ANALYTISCHES HILFSMITTEL MIT STERILSCHUTZ FÜR DIE LANZETTE UND TESTKAMMER

Sampling catheter having radially extending mixers

A catheter 50 for taking a plurality of samples from within a length of a blood vessel. The catheter includes an elongate central body 52 arranged to be inserted into and positioned along a central region of a blood vessel. A plurality of collection areas are defined along the elongate central body for collecting samples at the central region of the blood vessel. A plurality of mixers 54, 55, 56, 57 are provided radially outwardly of the elongate central body 52 and arranged to create a flow of blood from a boundary layer at a wall of the blood vessel to the elongate central body 52. This enables the collection areas to collect samples from the boundary layer.

Improvements relating to finger pricking lancets

A method for hardening at a surface a component

Lancet

MICRON-ENNOBLE FOR MINIMAL INVASIVE MEDICINE ADMINISTRATION OR FOR DIAGNOSTIC SAMPLE TAKING

LANZETTE, LANZETTENVORRATSBAND AND STECHGERÄT FOR PRODUCING A PARTING WOUND

LANZETTEN FOR THE WITHDRAWAL OF BODY FLUIDS ON A VOLUME

ANALYTIC AID WITH STERILE PROTECTION FOR THE LANZETTE AND TEST CHAMBER

MEDICINE PRODUCT FOR THE ANALYTENÜBERWACHUNG AND DRUG DELIVERY

DEVICE FOR COLLECTING LIQUIDS WITH INTEGRATED LANZETTE AND REACTION RANGE

LANZETTENSYSTEM

ANALYTIC AID WITH LANZETTE AND TEST ELEMENT

DEVICE FOR IMPROVEMENT THE TRANSDERMALEN ADMINISTRATION OF MEDICINES OR THE DECREASE OF BODY FLUIDS

DEVICE FOR IMPROVEMENT THE TRANSDERMALEN DECREASE OF BODY FLUIDS

MIKROKLINGEANORDUNGSAUFPRALLAPPLIKATOR

STRIP FOR THE PACKING OF ONE MULTI-PAYS FROM DEVICES TO THE LIQUID WITHDRAWAL AND TESTING AS WELL AS PROCEDURE FOR THE PRODUCTION AND USE OF THE STRIP

DEVICE FOR IMPROVEMENT THE TRANSDERMALEN ADMINISTRATION OF MEDICINES OR THE DECREASE OF BODY FLUIDS

Medical device for analyte monitoring and drug delivery

MEDICAL DEVICE FOR ANALYTE MONITORING AND DELIVERY 5 Disicosed is an ingestible, implantable or wearable medical device comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical 10 parameter data of an interaction between the disease marker biological analyte with the bioactive agent; a biometric recognition device capable of comparing the physical parameter data with an analyte interaction profile; optionally a therapeutic agent releasing device capable of controlling release of the therapeutic agent from the reservoirs; an interface device capable of facilitating communications between the microarray scanning 15 device, biometric recognition device and the therapeutic agent releasing device ...

Method for producing an analytical magazine

A method for producing an analytical magazine (110) is proposed. The analytical magazine (110) is designed for receiving a plurality of analytical aids (134) in a plurality of chambers (122). The method comprises the following steps: - providing at least a first component (112) of the analytical magazine (110), wherein the first component (112) comprises a plurality of receptacles (120), - providing a plurality of analytical aids (134), wherein the analytical aids (134) are connected to one another, and preferably aligned in relation to one another, by at least one holding element (144), - introducing the analytical aids (134) into the receptacles (120); and - separating the analytical aids (134) from the holding element (144).

Biological fluid sampling apparatus

Microfluidic devices and fabrication

Methods for mass production of new microfluidic devices are described. The microfluidic devices may include an array of micro-needles with open channels in fluid communication with multiple reservoirs located within a substrate that supports the micro-needles. The micro-needles are configured so as to sufficiently penetrate the skin in order to collect or sample bodily fluids and transfer the fluids to the reservoirs. The micro-needles may also deliver medicaments into or below the skin.

Percutaneous biological fluid constituent sampling and measurement devices and methods

INTRACUTANEOUS EDGED MICRONEEDLE STRUCTURE

A hollow microneedle with a substantially sharp edge is provided that includes at least one longitudinal blade at the top surface or tip of the microneedle to aid in penetration of the stratum corneum of skin. The blade's edge can run the entire length of the microneedle from its very top surface to its bottom surface where it is mounted onto the substrate, or the edge can be discontinued partway down the length of the microneedle. In a preferred embodiment, a three pointed star-shape is used, in which each blade has an isosceles triangular cross-section when viewed from the top of the microneedle. At least one hole through the substrate is located near the side surfaces of the pairs of blades of the solid microneedle.

A MICRONEEDLE AND A CHIP

A microneedle and a chip are disclosed for extraction of fluids. The microneedle (101) provided on a substrate (102), comprises an elongated body (503) extending from a distal end (504) with a bevel (505) to a proximal end (506) on the substrate along a longitudinal axis; the elongated body comprises a capillary bore (507) extending in a longitudinal direction thereof and defines a fluid path (508); the proximal end is integrally connected with the substrate and the capillary bore is in fluid communication with a fluid channel (309) of the substrate. The cross-sectional area of the capillary bore in the distal end is larger than the cross-sectional area of the capillary bore in the proximal end.

DIAGNOSTIC TAPE UNIT AND A PROCESS FOR ITS PRODUCTION

The invention concerns a process for producing a diagnostic tape unit (10) i n which disposable test units (20) are applied to a rollable transport tape (18) and the transport tape (18) is wound onto an unwinding spool (14) and is connected t o a take-up spool (16) such that the test units (20) can be successively made available to a user by winding on the transport tape (18). According to the invention it is proposed that the leading end of the transport tape (18) is connected to the take-up spool (16) by means of an auxiliary tape (24) and/or the trailing end of the transport tape is connected to the unwinding spool (14) by means of an auxiliary tape (24', 24").

LANCETS FOR BODILY FLUID SAMPLING SUPPLIED ON A TAPE

A multi-use lancing device including a housing having a lancet opening and containing a supply reel, a storage reel, and a take-up reel, wherein the supply reel, the storage reel, and the take-up reel are each configured to rotate independently of the housing, an elongated flexible carrying tape configured for reel-to-reel transfer from the supply reel to the storage reel; a plurality of lancets sequentially positioned along the carrying tape and each having a lancet length and a distal portion defining a sharp tip; and a sterile removable cover over the lancets in the supply reel, where rotation of the take-up reel removes the cover from the lancets as the lancets are advanced from the supply reel to the storage reel.

APPARATUS AND METHODS FOR DRUG DELIVERY USING MICRONEEDLES

A microneedle has a proximal end portion and a distal end portion and defines a lumen. The proximal end portion is configured to be coupled to a cartridge to place the lumen in fluid communication with the cartridge. The proximal end portion includes a base surface that is configured to be placed in contact with a surface of a target tissue. The distal end portion of the microneedle includes a beveled surface. The beveled surface defines a tip angle of less than about 20 degrees and a ratio of a bevel height to a bevel width of less than about 2.5.

LANCETS FOR BODILY FLUID SAMPLING SUPPLIED ON A TAPE

A method for obtaining a bodily fluid sample, including providing a reel-to- reel tape carrying lancets non-circular in cross section along a major portion of their length, the tape having a supply section, a storage section and an activating section spanning between and translatable independently of the supply and storage sections; advancing the tape to position a first lancet adjacent a bend in the activating section of the tape with a sharp tip of the first lancet spaced from the tape; translating only the activating section with a mechanism without activating the supply and storage sections to pierce tissue with the sharp tip; and after the piercing, advancing the tape to bring the sharp tip closer to the tape. The supply and storage sections are respectively wrapped around supply and storage reels spaced apart from each other. Either the supply reel or the storage reel is configured to advance the tape.

LANCETS FOR BODILY FLUID SAMPLING SUPPLIED ON A TAPE

... ²A device for bodily fluid sampling including a housing having a lancet opening ²and a ²carrying tape having at least one test media for receiving a bodily fluid and ²at least One lancet ²contained on the tape, with the test media being provided on the tape near the ²lancet. Also, a ²method of contacting bodily fluid with a test media including advancing a ²carrying tape having a ²lancet and a test media fixed thereon to position the lancet in an activating ²position, engaging the ²lancet with an activator, activating the lancet to obtain the bodily fluid ²sample, positioning the ²test media adjacent the lancet opening to receive the bodily fluid sample, and ²contacting the ²bodily :fluid sample to the test media.²² ...

MECHANISM TO THE BLOOD WITHDRAWAL.

Surgical instrument i.e. injection needle, for patient, has instrument section insertable into patient body and provided with ultrasonic reflective coating on part of its outer surface, where section is formed in shape of shaft or cannula

The instrument (10) has an instrument section (18) insertable into a patient body and provided with an ultrasonic reflective coating (36') on a part of its outer surface. The section is formed in shape of a hollow shaft (20) or cannula, and has diameter in a range of o.5 mm to 5 mm. The coating is made of an electrically insulating material e.g. ceramic such as non-oxide ceramic, silicon carbide, boron nitride or mixed-oxide ceramic. The coating is comprised of yttrium, aluminum, boron, nitrogen, silicon, oxygen, silicon, carbon, diamond or zirconium.

DISPOSABLE BLOOD-LETTING LANCET

lancet for sampling bodily fluid supplied in a tape

método para produção de cartucho analítico

Improved micro-needles and methods of manufacture and use thereof

A micro-needle is provided which is particularly useful for the minimally invasive sampling of a biological fluid and/or the minimally invasive delivery of a drug or other formulation across the skin. The micro-needle has a structure having a base at a proximal end and a vertex at a distal end, and an open lumen extending there through and through which fluid may be transferred. The structure defines a structural axis that intersects the lumenal axis defined by the open lumen. The point of intersection between these axes is at a point below the vertex of the micro-needle to provide a sharp apex at the distal end of the micro-needle and defines the general configuration of the distal end of the micro-needle, which may be selected or customized depending on the intended use of the microneedle. The micro-needle may be integral with a measurement device for measuring the concentration of a constituent within sampled biological fluid and/or with a fluid reservoir for containing a fluid to be ...

POLYMERIC MICRONEEDLES AND RAPID ADDITIVE MANUFACTURING OF THE SAME

The invention generally relates to microneedle devices, methods of making same, pharmaceutical compositions comprising same, and methods of treating a disease comprising administering same. Specifically, the disclosed microneedle devices comprise a plurality of biocompatible microneedles having one or more of: (i) a curved, discontinuous (figure 5D), undercut (figures 1E, 28A, 28B), and/or perforated sidewall (figures 2, 3); (ii) a sidewall comprising a breakable support (figure 1); and (iii) a cross-section that is non-circular and non-polygonal (figure 6A). The microneedles may also be tiered (figures 4B, 29).

Medical needle and medical device

One of aspects of the present invention is to provide a medical needle extending along a predetermined direction and having a vertical cross-section taken along a plane perpendicular to the predetermined direction of which cross-sectional area varies based upon a distance from a needle tip. The medical needle includes a plurality of maximal points where the cross-sectional area of the vertical cross-section is locally maximal, and a plurality of minimal points where the cross-sectional area of the vertical cross-section is locally minimal. The vertical cross-section at the maximal point closest to the needle tip has the cross-sectional area not less than those at any other maximal points.

DIAGNOSTIC TAPE UNIT AND A PROCESS FOR ITS PRODUCTION

A diagnostic tape unit and a process for producing is are provided, in which disposable, test units are applied to a rollable transport tape which is wound onto an unwinding spool and is connected to a take-up spool such that the test units can be successively made available to a user by winding on the transport tape. One or both of the leading end and trailing end of the transport tape is connected to their corresponding spools by means of an auxiliary tape.

Systems and methods of sample processing and fluid control in a fluidic system

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

MICRONEEDLE

The application relates to microfluidic needles and their manufacturing methods. The microfluidic needle comprises an interface portion containing at least one fluid communication channel, an elongated needle portion (40) projecting away from the interface portion (44), the needle portion having a tip and sidewalls connecting the tip to the interface portion, and at least two microfluidic channels (43 A-B) within the needle portion in fluidic connection with the at least one communication channel, the microfluidic channels being at least partly oriented parallel to the elongated needle portion. According to the application, the microfluidic channels exit the needle portion at the sidewalls of the needle portion. The needle may be fabricated by ALD-assisted silicon micromachining. The needle can be used for injection and/or sampling fluids to/from tissue or individual cells.

INTRAVENOUS THERAPY SYSTEM FOR BLOOD VESSEL ACCESS VIA A CURVED NEEDLE AND CURVED CATHETER

An intravenous therapy system may include a curved needle; and a curved catheter formed around the outside surface of the curved needle; wherein, upon insertion of a first length of the curved needle and curved catheter into a patient's body, a curvature angle of the curved needle and curved catheter causes the curved needle and curved catheter to intersect axially with a blood vessel in the patient's body.

Biological fluid constituent sampling and measurement devices and methods

A device for accessing biological fluid, sampling biological fluid constituents and determining the concentration of at least one target constituent within the accessed biological fluid is provided. The device has at least one micro-piercing member used to penetrate the skin to a selected depth and to access biological fluid, a constituent sampling means and a constituent measuring means. The constituent sampling means comprises a constituent transfer medium, such as a hydrophilic gel material, by which sampled constituents are transferred from the micro-piercing member to the measuring means. The measuring means includes an electrochemical cell having at least one porous electrode through which at least one sampled constituent is caused to enter into the electrochemical cell. Methods of sampling constituents within the skin and measuring the sampled constituents, as well as kits for practicing the invention are provided.

Автоматически втягиваемая игла для забора крови

Изобретение относится к медицинской технике, а именно к автоматически втягиваемой игле для забора крови, включающей иглодержатель (1), содержащий первую трубку (11), вторую трубку (12) и хвостовую часть (13); иглу (2), установленную в первую трубку (11); встроенную выдвижную втулку (3), представляющую собой удлиненный сквозной элемент, поперечное сечение которого имеет С-образную форму; полый и удлиненный корпус иглы (4); пружину, надетую на первую трубку (11). Вторая трубка (12) устанавливается во встроенную выдвижную втулку (3) с возможностью скольжения вперед и назад. Встроенная выдвижная втулка (3) устанавливается в корпусе иглы (4) с возможностью перемещения вперед и назад. Механизм фиксации образован хвостовой частью иглодержателя (13) и корпусом иглы (4). Когда хвостовая часть держателя (13) выходит из зацепления с корпусом иглы (4), усилие пружины толкает вторую трубку (12), заставляя ее скользить назад, сдвигая встроенную выдвижную втулку (3) назад в положение фиксации с корпусом ...

СПОСОБ СОЗДАНИЯ МАГАЗИНА АНАЛИТИЧЕСКИХ СРЕДСТВ

... 1. Способ изготовления магазина (110) аналитических средств, в котором магазин (110) аналитических средств выполнен с возможностью приема множества аналитических вспомогательных средств (134) во множестве отсеков (122), при этом способ содержит следующие этапы:создание, по меньшей мере, одного первого компонента (112) магазина (110) аналитических средств, при этом первый компонент (112) содержит множество приемных частей (120),создание множества аналитических вспомогательных средств (134), при этом аналитические вспомогательные средства (134) соединены друг с другом и предпочтительно ориентированы относительно друг друга посредством, по меньшей мере, одного удерживающего элемента (144),введение аналитических вспомогательных средств (134) в приемные части (120), при этом множество или предпочтительно все отсеки (122) загружаются одновременно; иотделение аналитических вспомогательных средств (134) от удерживающего элемента (144), при этом аналитические вспомогательные средства (134) изготовлены ...

Устройство дл определени концентрации анализируемого вещества и способы их применени

... 1. Индикаторная полоска для определения концентрации, по меньшей мере, одного анализируемого вещества в физиологической пробе, содержащая множество прикрепленных к ней игл для прокалывания кожи, при этом индикаторная полоска выполнена с возможностью приема в измеритель. 2. Индикаторная полоска по п.1, в которой множество элементов для прокалывания кожи расположено по существу перпендикулярно индикаторной полоске. 3. Индикаторная полоска по п.1, в которой множество элементов для прокалывания кожи расположено по существу параллельно индикаторной полоске. 4. Индикаторная полоска по п.1, которая дополнительно содержит два электрода, разделенные прокладочным слоем, при этом, по меньшей мере, один электрод сопряжен с инертным материалом подложки. 5. Индикаторная полоска по п.4, в которой множество элементов для прокалывания кожи прикреплено к инертному материалу подложки. 6. Индикаторная полоска по п.4, в которой множество элементов для прокалывания кожи образовано указанным инертным материалом ...

СПОСОБ СОЗДАНИЯ МАГАЗИНА АНАЛИТИЧЕСКИХ СРЕДСТВ

... 1. Магазин (110) аналитических средств, содержащий множество аналитических вспомогательных средств (134), при этом магазин (110) аналитических средств имеет, по меньшей мере, два отсека (122), в которые аналитические вспомогательные средства (134) могут быть помещены, причем аналитические вспомогательные средства (134) помещают, по меньшей мере, в одни из отсеков (122), при этом каждое из аналитических вспомогательных средств (134) содержит, по меньшей мере, один тестирующий элемент (170) с, по меньшей мере, одним химическим реактивом (158) для распознавания, по меньшей мере, одного аналита в пробе жидкости, в частности, жидкости организма, при этом магазин (110) аналитических средств имеет корпус (156), по меньшей мере, с двумя компонентами (112, 148), причем, по меньшей мере, два компонента (112, 148) соединены друг с другом с помощью способа лазерной сварки, при этом первый из, по меньшей мере, двух компонентов (112, 148) и второй из, по меньшей мере, двух компонентов (112, 148) имеют ...

Verfahren zur selektiven Sterilisation von diagnostischen Testelementen

Die Erfindung betrifft ein Verfahren zur Herstellung integrierter, diagnostischer Testelemente, die einen Stechbereich und einen Nachweisbereich aufweisen. Der Stechbereich dient hierbei dem Erzeugen einer Hautöffnung und der Nachweisbereich dem Nachweis eines Analyts in einer Körperflüssigkeit. Durch die selektrive Sterilisation wird der Stechbereich, nicht jedoch der Nachweisbereich, durch Elektronenstrahlung sterilisiert. DOLLAR A Das erfindungsgemäße Verfahren umfasst die Schritte Abschirmung des Nachweisbereichs auf dem Testelement gegen Elektronenstrahlung und anschließende Bestrahlung des Testelements mit Elektronenstrahlung. DOLLAR A Weiterhin betrifft die Erfindung ein erfindungsgemäßes Verfahren, bei dem die Testelemente bzw. Stechbereiche zusammenhängend angeordnet sind und durch Bewegung der gesamten Anordnung in den Strahlungsbereich gebracht werden. DOLLAR A Schließlich betrifft die Erfindung ein diagnostisches Testelement, das gemäß dem erfindungsgemäßen Verfahren hergestellt ...

Catheter

Catheter

LANZETTENVORRICHTUNG TO DOTTING THE SKIN

PROCEDURE FOR THE PRODUCTION OF HOLDING FOR REPLACEABLE EVACUATED TEST TUBES FOR THE BLOOD WITHDRAWAL AND THEREBY MANUFACTURED PRODUCTS

BROKEN LANZETTE

LANZETTENVORRICHTUNG ZUM PUNKTIEREN DER HAUT

SYSTEM FOR THE WITHDRAWAL OF SMALL BODY FLUID QUANTITIES

PROCEDURE FOR THE PRODUCTION OF MICRON ENNOBLING AND ITS APPLICATIONS

DIAGNOSTIC TEST ELEMENT AND PROCEDURE FOR ITS PRODUCTION

MICRON ARISTOCRACY MECHANISMS AND PROCEDURES FOR THE THEIR PRODUCTION

INTEGRATED LANZETTE AND TESTSTREIFEN FOR ANALYTIC MEASUREMENT

PROCEDURE FOR THE PRODUCTION OF A STECHELEMENTS

MEDICAL NEEDLE AND MEDICINE PRODUCT

PHYSIOLOGICAL COLLECTING DEVICES

LANZETTENVORRICHTUNG TO DOTTING THE SKIN

A DISPOSABLE NEEDLE ASSEMBLY HAVING SENSORS FORMED THEREIN PERMITTING THE SIMULTANEOUS DRAWING AND ADMINISTERING OF FLUIDS AND METHOD OF FORMING THE SAME

Biological fluid constituent sampling and measurement devices and methods

Method of reducing the effect of direct interference current in an electrochemical test strip

A microbiopsy device

A microbiopsy device for taking biological samples, comprising a body including two or more cutting elements for cutting tissue to form a biological sample; and a chamber inside the body for receiving and retaining the biological sample, the chamber having an opening between the cutting elements, wherein the cutting elements are arranged to cut a section of tissue having a width of less than 1 mm.

Methods and apparatus for lancet actuation

A lancet driver is provided wherein the driver exerts a driving force on a lancet during a lancing cycle and is used on a tissue site. The driver comprises of a drive force generator for advancing the lancet along a path into the tissue site, and a manual switch for a user interface input.

MICRONEEDLE DEVICES AND METHODS OF MANUFACTURE AND USE THEREOF

Microneedle devices for transport of therapeutic and diagnostic materials and/or energy across tissue barriers, and methods for manufacturing the devices, are provided. The microneedles are hollow and/or porous and have diameters between about l0nm and lmm. The microneedle devices permit drug delivery (or removal or sensing of body fluids) at clinically relevant rates across skin or other tissue barriers, without damage, pain, or irritation to the tissue. Microfabrication techniques are used to cost-effectively produce arrays of microneedles from metals, silicon, silicon dioxide, ceramic, and polymeric materials. Methods are provided for making porous or hollow microneedles.

A MICRONEEDLE AND A CHIP

A microneedle and a chip are disclosed for extraction of fluids. The microneedle (101) provided on a substrate (102), comprises an elongated body (503) extending from a distal end (504) with a bevel (505) to a proximal end (506) on the substrate along a longitudinal axis; the elongated body comprises a capillary bore (507) extending in a longitudinal direction thereof and defines a fluid path (508); the proximal end is integrally connected with the substrate and the capillary bore is in fluid communication with a fluid channel (309) of the substrate. The cross-sectional area of the capillary bore in the distal end is larger than the cross-sectional area of the capillary bore in the proximal end.

LANCETS FOR BODILY FLUID SAMPLING SUPPLIED ON A TAPE

A multi-use lancing device for sampling a bodily fluid including a housing , a carrying tape having at least one bend in an activating section, and lancets carried along the tape. A lancet adjacent the bend travels through an activating phase such that the distal portion having the sharp tip extends away from an adjacent surface of the carrying tape for lancing. The lancets are oriented such that their proximal portions precede their sharp tips as they are carried by advancement of the tape. The supply section and storage section of the carrying tape are respectively wrapped around supply and storage reels spaced apart from each other. The carrying tape is contained in the housing, the sharp tip of the lancet extends through a lancing slot for lancing tissue and the sharp tip of the lancet retracts through the lancing slot after forming an incision in tissue.

LANCETS FOR BODILY FLUID SAMPLING SUPPLIED ON A TAPE

A method for obtaining a bodily fluid sample, including providing a reel-to- reel tape carrying a first lancet on a service loop portion of the tape, the tape having a length and defining a supply section of the tape, a storage section of the tape, and the service loop portion of the tape that spans between the supply and the storage sections, the service loop portion of the tape is translatable independently of the supply and the storage sections, moving either the storage section or the supply section of the tape to position the first lancet carried by the tape adjacent a bend in the service loop portion of the tape, and relatively translating only the service loop portion of the tape with a mechanism without activating the remainder of the tape to lance tissue with the first lancet.

BODY FLUID LANCING, ACQUIRING, AND TESTING CARTRIDGE DESIGN

A lancet wheel (22) having a rim (23) with a plurality of lancets (24) extending radially inward from the rim is dropped in a circular frame (30) having a plurality of spokes forming a plurality of chambers (32) for facilitating drop -in assembly of the modular lancet wheel with the frame. A test ring (26) having a plurality of test sections (28) is assembled on the frame such that one test section is located adjacent each lancet to form an integrated cartridge (20). Each lancet includes a lancet tip (46) defining a capillary groove sized to collect a body fluid sample from the incision via capillary action. The lancet tip exits the chamber to form the incision in skin, the capillary groove collects the body fluid sample, the lancet tip retracts into the chamber, and a portion of the lancet contacts the test section to transfer the sample from the capillary groove to the test section to analyze the sample.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Said apparatus includes a sheath, a device support movable between a proximal and distal position, a sharp support movable between a proximal and distal position, a handle movable between a proximal and distal position, and a driver.

METHODS AND STRUCTURES FOR ASSEMBLING LANCET HOUSING ASSEMBLIES FOR HANDHELD MEDICAL DIAGNOSTIC DEVICES

A method of assembling a lancet housing assembly (600) comprising multiple lancets for use in a portable handheld medical diagnostic device (10) for sampling bodily fluids from a skin site of a patient is provided. The method includes forming a plurality of the lancet structures (606) in a lancet sheet (704). The lancet sheet has a removeable ledge (706,708) for releasing the lancet structures. The removeable ledge of the lancet sheet is flexed for releasing the lancet structures from the removeable ledge.

LANCET NEEDLE WITH ALIGNMENT AND RETENTION NOTCH

A lancet needle (10) with an alignment and engagement notch (30), with material of the lancet body extending into the notch to more securely retain the needle to the lancet body, whereby a shorter needle can be utilized than with typical lancets. The notch optionally also provides a registration point for rotational and/or axial alignment of the needle during overmolding to form the lancet body, for example to maintain consistent positioning of the needle's beveled point.

INTRA-MOLD STERILIZATION OF PLASTIC-EMBEDDED NEEDLE

Methods for intra-mold sterilization of a plastic-embedded metal component of a product, such as a medical lancet having a metal needle embedded within a plastic lancet body. For example, a lancet needle is retained within a mold, plastic is injected to encapsulate the needle, and a specified minimum temperature is maintained for a specified minimum cycle time. In example forms, the specified minimum mold temperature is at least about 370 degrees Fahrenheit and the specified minimum cycle time is at least about 10 seconds.

ANTICOAGULANT INTERNALLY COATED NEEDLE

To prevent the dilution effect that causes inaccuracy in the measurement of the characteristics of blood drawn from a patient, a needle assembly (2) has the interior portion of its cannula (6) and at least one portion of its hub (4) covered by a dry coat of anticoagulant. To provide the dry coat of anticoagulant onto the interior surfaces of the cannula (6) and the hub (4), a liquid anticoagulant is atomized thereto so that an even coat of the anticoagulant is provided to the interior surfaces of the cannula and hub. The volume and concentration of the anticoagulant atomized to the inside of the needle assembly are controlled as the liquid anticoagulant is ultra-sonically atomized to the interior portion of the needle assembly.

Cateter para tomar una pluralidad de muestras dentro de un vaso sanguineo, que incluye un cuerpo central elongado, al menos un area de recoleccion a lo largo del cuerpo central, y al menos un mezclador con elementos de tipo pala alrededor del cuerpo central para crear un flujo desde una pared del vaso sanguineo al cuerpo central; y método.

CATETER (10) Y METODO ASOCIADO PARA TOMAR UNA PLURALIDAD DE MUESTRAS DENTRO DE UNA LONGITUD DE UN VASO SANGUINEO (2), QUE INCLUYE: UN CUERPO CENTRAL ELONGADO (12, 52, 122, 164) DISPUESTO PARA SER INSERTADO EN Y POSICIONADO A LO LARGO DEL VASO SANGUINEO (2); AL MENOS UN AREA DE RECOLECCION (14) DEFINIDA A LO LARGO DEL CUERPO CENTRAL ELONGADO (12) PARA RECOGER LAS MUESTRAS EN LA REGION CENTRAL DEL VASO SANGUINEO; Y AL MENOS UN MEZCLADOR (18, 28, 38, 44-47, 54-57, 124, 125) PROVISTO RADIALMENTE HACIA EL EXTERIOR DEL CUERPO CENTRAL ELONGADO (12) Y DISPUESTO PARA INTERFERIR CON EL FLUJO DE SANGRE A LO LARGO DEL VASO (2), DE MODO TAL DE CREAR UN FLUJOSANGUINEO DESDE UNA CAPA LIMITE A UNA PARED DEL VASO SANGUINEO (2) AL CUERPO CENTRAL ELONGADO (12) A FIN DE PERMITIR AL MENOS UN AREA DE RECOLECCION (14) PARA RECOGER MUESTRAS DESDE LA CAPA LIMITE.

MICRONEEDLE DEVICES AND METHODS OF MANUFACTURE AND USE THEREOF

Microneedle devices are provided for transport of therapeutic and biological molecules across tissue barriers. In a preferred embodiment, the microneedle devices permit drug delivery (or removal or sensing of body fluids) at clinically relevant rates across skin or other tissue barriers, without damage, pain, or irritation to the tissue. Methods of making these devices, which can include hollow and/or porous microneedles, are also provided. A preferred method for making a microneedle includes forming a micromold having sidewalls which define the outer surface of the microneedle, electroplating the sidewalls to form the hollow microneedle, and then removing the micromold from the microneedle. In a preferred method of use, the microneedle device is used to deliver fluid material into or across a biological barrier from one or more chambers in fluid connection with at least one of the microneedles. The device preferably further includes a means for controlling the flow of material through the microneedles. Representative examples of these means include the use of permeable membranes, fracturable impermeable membranes, valves, and pumps.

DEVICE FOR ENHANCING TRANSDERMAL SAMPLING

A device (10, 88, 98, 104) for piercing the stratum corneum of a body surface to form pathways through which an agent can be withdrawn. The device comprises: a sheet (6) having a plurality of microblades (4) extending downward therefrom for piercing the stratum corneum, and a collector (26, 90, 106) on the sheet (6) which withdraws the agent through the pathways.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

Tape transport lance sampler

A lancet-sampler system is configured to automatically remove a protective cover from a lancet and automatically unpack a test pad just prior to use. This minimizes the risk of injury and reduces the chance of cross-contamination between the lancet and the test pad. The lancet defines a capillary groove for drawing body fluid from the incision via capillary action and a sample transfer opening for collecting the fluid from the groove. A carrier tape is coupled to the lancet. The carrier tape includes a test pad for analyzing the fluid. The tape is folded around the test pad to form an airtight package. The test pad is located at a position to align with the sample transfer opening when the tape is unfolded. The protective cover covers a portion of the lancet, and when the tape is pulled, the protective cover is automatically pulled from the lancet.

MEDICAL PUNCTURE NEEDLE AND METHOD FOR MANUFACTURING PUNCTURE NEEDLE

A medical puncture needle includes a rod-shaped main body portion; and a blade surface formed at a distal end portion of the main body portion. The blade surface includes a first blade surface portion and a second blade surface portion that intersect to form a blade edge. A needle tip is formed at a location at which a distal end of the blade edge intersects a first ridge line at an outer edge of the first blade surface and a second ridge line at an outer edge of the second blade surface. At least one of the blade surface portions is planar, and, in a central axis direction of the main body portion, said at least one blade surface portion extends to a location proximal of a middle position of a blade surface region in which the blade surface is formed.

Method for the selective sterilization of diagnostic test elements

The invention concerns a method for producing integrated, diagnostic test elements (1) which have a lancing area (2) and a detection area (3). The lancing area is used to generate an opening in the skin and the detection area is used to detect an analyte in a body fluid. The selective sterilization sterilizes the lancing area but not the detection area by electron radiation. The method according to the invention comprises the steps of screening the detection area on the test element against electron radiation and subsequently irradiating the test element with electron radiation. The invention additionally concerns a method according to the invention in which the test elements and lancing areas are in a connected arrangement and are brought into the radiation area by moving the entire arrangement. Finally the invention concerns a diagnostic test element which has been produced according to the inventive method.

Lancet integrated test element tape dispenser

A lancet integrated test element tape includes a plurality of lancet integrated test elements. The lancet integrated test elements each include a lancet configured to form an incision in tissue and a test element configured to analyze body fluid from the incision in the tissue. A cartridge includes a supply compartment configured to store an unused section of the tape. The tape is folded within the supply compartment to limit damage to the lancet integrated test elements. The cartridge can further include a waste compartment in which a used section of the tape is stored. An indexing mechanism moves the tape between the supply and waste compartments.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter. 125-. (canceled)26. An apparatus comprising:a housing;a sheath slidably coupled with the housing and defining an interior cavity;a sharp carrier moveable within the interior cavity and having a proximal edge;a device carrier configured to move within the interior cavity, the device carrier comprising a proximally-extending carrier arm moveable from a first position with the proximally-extending carrier arm initially engaged with the proximal edge to a second position with the proximally-extending carrier arm disengaged from the proximal edge; anda spring disposed between the sharp carrier and the device carrier;wherein the spring is configured to be secured in a compressed state when the proximally-extending carrier arm is in the first position, and the spring is configured to be released to urge the sharp carrier away from the device carrier when the proximally-extending carrier arm is moved to the second position.27. The apparatus of claim 26 , wherein the proximally-extending carrier arm comprises a detent at a proximal end thereof.28. The apparatus of claim 26 , wherein a proximal end portion of the proximally-extending carrier arm is configured to extend radially outward from the sharp carrier when the proximally-extending carrier arm is moved to the second position.29. The apparatus of claim 26 , further comprising a cylindrical support wall having an interior support wall surface to engage an outer surface of the proximally-extending carrier arm.30. The apparatus of claim 29 , wherein the proximally-extending carrier arm is configured to flex in response to a bias of ...

TAPE TRANSPORT LANCE SAMPLER

A lancet-sampler system is configured to automatically remove a protective cover from a lancet and automatically unpack a test pad just prior to use. This minimizes the risk of injury and reduces the chance of cross-contamination between the lancet and the test pad. The lancet defines a capillary groove for drawing body fluid from the incision via capillary action and a sample transfer opening for collecting the fluid from the groove. A carrier tape is coupled to the lancet. The carrier tape includes a test pad for analyzing the fluid. The tape is folded around the test pad to form an airtight package. The test pad is located at a position to align with the sample transfer opening when the tape is unfolded. The protective cover covers a portion of the lancet, and when the tape is pulled, the protective cover is automatically pulled from the lancet.

TAPE TRANSPORT LANCE SAMPLER

A lancet-sampler system is configured to automatically remove a protective cover from a lancet and automatically unpack a test pad just prior to use. This minimizes the risk of injury and reduces the chance of cross-contamination between the lancet and the test pad. The lancet defines a capillary groove for drawing body fluid from the incision via capillary action and a sample transfer opening for collecting the fluid from the groove. A carrier tape is coupled to the lancet. The carrier tape includes a test pad for analyzing the fluid. The tape is folded around the test pad to form an airtight package. The test pad is located at a position to align with the sample transfer opening when the tape is unfolded. The protective cover covers a portion of the lancet, and when the tape is pulled, the protective cover is automatically pulled from the lancet.

PUSH- OR TWIST- INITIATED BLOOD METERING, FILTERING AND/OR STORAGE

A device uses twist- or push-initiated force to collect, meter, filter and store a blood sample.

Hollow microneedle with beveled tip

An article having at least one microneedle (160, 260) is provided. The microneedle includes a base (162), an elongated body (161) having a central axis (130) and a body diameter (168), a tip portion (166), and a hollow channel (170). The a tip portion includes a tip (164), a first bevel face (140) oriented diagonally with respect to the central axis and extending through at least 75% of the body diameter, a second bevel face (146) oriented substantially perpendicular to the central axis and intersecting the first bevel face, and a bevel opening defined by a first edge (174) of the first bevel face and a second edge (176) of the second bevel face. The hollow channel extends axially into the body from the bevel opening (172).

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

ЛАНЦЕТ

Изобретение относится к медицине и может быть использовано для получения капли крови. Ланцет для прокалывания кожи включает иглу, тело для удерживания иглы и колпачок для защиты, по меньшей мере, острия иглы. По меньшей мере, один захватный элемент для колпачка сформован на теле, и по меньшей мере, один захватный элемент для тела сформован на колпачке. Захватный элемент выполнен с возможностью создания освобождаемого механического сцепления с захватным элементом, тем самым с возможностью фиксации колпачка на теле в положении защиты. Способ изготовления ланцета для прокалывания кожи включает размещение части иглы в форме, литьевое формование тела вокруг иглы с обеспечением выступа острия иглы из тела и литьевое формование колпачка вокруг, по меньшей мере, острия иглы. 2 н. и 9 з.п. ф-лы, 3 ил.

Прокалывающий кожу элемент, индикаторна полоска и система дл определени концентрации анализируемого вещества, способ вз ти физиологического образца

... 1. Прокалывающий кожу элемент, содержащий по меньшей мере один канал для текучей среды, в котором по меньшей мере существенная часть дальнего конца указанного по меньшей мере одного канала для текучей среды открыта для внешней среды. 2. Прокалывающий кожу элемент по п.1, в котором указанная существенная часть дальнего конца указанного по меньшей мере одного канала для текучей среды открыта для внешней среды на одной или более сторонах, или в любой точке окружности указанного по меньшей мере одного канала для текучей среды. 3. Прокалывающий кожу элемент по п.1, в котором вся длина указанного дальнего конца указанного по меньшей мере одного канала для текучей среды открыта для внешней среды на указанной одной или более сторонах, или в любой точке окружности указанного прокалывающего кожу элемента. 4. Прокалывающий кожу элемент по п.1, в котором указанный по меньшей мере один канал для текучей среды оканчивается вблизи дальней оконечности. 5. Прокалывающий кожу элемент по п.1, в котором содержится ...

Streifen zur Verpackung einer Mehrzahle von Geräten zur Flüssigkeitsentnahme und Testung sowie Verfahren zur Herstellung und Verwendung des Streifens

Geschlossenes Lanzettenband mit einer Mehrzahl von Lanzetten

Die Erfindung betrifft ein geschlossenes Lanzettenband mit einer Mehrzahl von Lanzetten (1), wobei jede einzelne Lanzette (1) einem sie haltenden Lanzettenkörper (2) aufweist, aus dem ein distales Lanzettenende (3) herausragt, und wobei benachbarte Lanzettenkörper (2) mittels eines Steges (5) derart verbunden sind, dass zwischen einer Mittellängsachse (6) des geschlossenen Lanzettenbandes und den Mittellängsachsen (7) der einzelnen Lanzetten (1) ein spitzer Winkel gebildet ist und dass die Stege (5) zur parallelen Ausrichtung der Lanzetten (1) zueinander beweglich bzw. elastisch ausgebildet sind.

Lancet

A skin pricking lancet 101 comprising a needle 104, a body 102 for holding the needle 104 and a cap 103 for shielding at least the tip of the needle 104. At least one cap engagement formation 106 is formed on the body 102, and at least one body engagement formation 108 is formed on the cap 102. The body engagement formation 106 is configured to form a releasable mechanical interlock with the cap engagement formation 108, thereby securing the cap 103 to the body 102 in the shielded position.

LANZETTEN IMPROVEMENTS CONCERNED

POLYGONAL ONE LANZETTENNADEL

Lancet integrated test element tape dispenser

A lancet integrated test element tape includes a plurality of lancet integrated test elements. The lancet integrated test elements each include a lancet configured to form an incision in tissue and a test element configured to analyze body fluid from the incision in the tissue. A cartridge includes a supply compartment configured to store an unused section of the tape. The tape is folded within the supply compartment to limit damage to the lancet integrated test elements. The cartridge can further include a waste compartment in which a used section of the tape is stored. An indexing mechanism moves the tape between the supply and waste compartments.

Glucose Monitoring System

A body fluid sampling system for use on a tissue site includes a drive force generator and one or more microneedles operatively coupled to the drive force generator. Each of a microneedle has a height of 500 to 2000 μm and a variable tapering angle of 60 to 90°. A sample chamber is coupled to the one or more microneedles. A body fluid is created when the one or more microneedles pierces a tissue site flows to the sample chamber for glucose detection and analysis.

Integrated lancing device

A lancing device is provided that has a housing with a length greater than a width. Electronics are positioned in an interior of the housing. A test strip aperture is in the housing and is adapted to receive a body fluid test strip. A lancet aperture is positioned in line with the test strip aperture.

Tissue penetration device

A body fluid testing device has at least one penetrating member and a penetrating member driver configured to be coupled to the at least one penetrating member. A plurality of analyte sensors are coupled to a spoked disk substrate. Each of a penetrating member can pass between spokes of the disk substrate to provide that a used penetrating member can be removed and a new penetrating inserted without removing the disk. A disposable houses the at least one penetrating member and the plurality of analyte sensors.

Lancet, method for manufacturing the lancet, and mold for the method

There is provided a process of producing a lancet which suppresses curving (or flexing) of the front end portion of the pricking member. In the production of a lancet by injection molding of a resin with a pricking member inserted in a mold, upon forming at least a portion of a lancet cap in which portion a molten resin supplied to the mold surrounds a front end portion of the pricking member, a mold is used which is configured such that at least a portion of the molten resin which forms said portion of the lancet cap flows along the front end portion including a leading end of the pricking member toward its leading end.

SYSTEM FOR WITHDRAWING SMALL AMOUNTS OF BODY FLUID

A system is provided for withdrawing small amounts of body fluid from an animal or human. The system includes a holder and a disposable lancing unit attached to the holder. The lancing unit also includes an open capillary channel for transporting the body fluid and piercing the skin. 1. A system , comprising:a disposable lancing unit having a needle with a distal end for piercing a surface of skin, wherein the needle has at least one capillary structure that is open to the outside from at least the distal end to at least an upper end of the needle; anda drive unit configured to hold the distal end of the needle below the surface of the skin and the upper end above the surface of the skin during fluid collection.2. The system of claim 1 , in which the disposable lancing unit has a holding area.3. The system of claim 2 , in which the holding area has a detection zone for detecting one or several analytes claim 2 , the detection zone being arranged for taking up body fluid from the capillary structure.4. The system of claim 3 , wherein the detection zone includes a reagent for detecting the analytes in the body fluid.5. The system of claim 2 , in which the capillary structure and holding area are integrally connected together.6. The system of claim 2 , in which the holding area and capillary structure are integrally manufactured from a single piece of material.7. The system of claim 2 , in which the holding area and capillary structure are manufactured from a semiconductor.8. The system of claim 1 , wherein the drive unit is configured to partially retract the lancing unit in the skin so that the capillary structure remains in part in the skin to promote pooling of body fluid.9. The system of claim 1 , in which the length of the capillary structure is in the range from 0.3 to 3 mm and the cross-section of the capillary structure is in the range from 0.03 to 0.8 mm.10. The system of claim 1 , wherein:the capillary structure has an aspect ratio from 2 to 5; andthe ...

Low pain penetrating member

Reducing the volume or drag on skin or sharpness of the penetrating member entering the wound during the cutting process will reduce the pain associated with lancing, and result in less power desired for retraction of the penetrating member from the skin. A variety of other penetrating member configuration as shown in the application.

Sensor module with enhanced capillary flow

A sensor module is disclosed herein. The sensor module includes a main housing defining an analysis zone within the housing. The sensor module also includes a skin piercing member mounted within the main housing. The skin piercing member is movable relative to the main housing between a retracted position and an extended position. The main housing of the sensor module defines a fluid sample flow passage that extends from a sampling end of the main housing to the analysis zone. The fluid sample flow passage includes a funnel structure through which the skin piecing member extends when in the extended position. The fluid sample flow passage also includes capillary flow enhancing slots that extend outwardly from opposite sides of the funnel structure.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 119-. (canceled)20. A glucose monitoring system comprising: the glucose sensor, wherein a distal end of the glucose sensor is configured to be inserted under skin of the subject;', 'a distal surface including an adhesive layer, wherein the distal surface is configured to be positioned on the skin of the subject such that the adhesive layer adheres to the skin of the subject;', 'an interior of the insertion assembly including a first spring in a loaded position, a second spring, a sliding member, and a straight track having a length, wherein the sliding member is configured to move only within the straight track; and', wherein the button is further configured to release the first spring from the loaded position upon being pressed, such that the first spring causes the sliding member to move within the straight track along a second axis different from the first axis, wherein the second axis is defined by the length of the straight track,', 'wherein movement of the sliding member within the straight track causes an actuator to advance in a distal direction along an insertion axis different from the first axis and the second axis, wherein advancement of the actuator causes advancement of a sharp and the glucose sensor in the distal direction along the insertion axis such that the distal end of the glucose sensor is inserted under the skin of the subject,', 'wherein the sliding member is further configured to continue moving within the straight track after the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis,', 'wherein the sliding member is operatively engaged with the actuator throughout the movement of the sliding member within the straight track,', 'wherein, the second spring is configured to expand and retract the sharp in a proximal direction along the insertion axis while the distal ...

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 119-. (canceled)20. A glucose monitoring system comprising: the glucose sensor, wherein a distal end of the glucose sensor is configured to be inserted under skin of the subject;', 'a distal surface including an adhesive layer, wherein the distal surface is configured to be positioned on the skin of the subject such that the adhesive layer adheres to the skin of the subject;', 'an interior of the insertion assembly including a first spring in a loaded position, a second spring, a sliding member, and a straight track having a length, wherein the sliding member is configured to move only within the straight track; and', wherein the button is further configured to release the first spring from the loaded position upon being pressed, such that the first spring causes the sliding member to move within a first section of the straight track along a second axis different from the first axis, wherein the second axis is defined by the length of the straight track,', 'wherein movement of the sliding member within the first section of the straight track causes an actuator to advance in a distal direction along an insertion axis different from the first axis and the second axis, wherein advancement of the actuator causes advancement of a sharp and the glucose sensor in the distal direction along the insertion axis such that the distal end of the glucose sensor is inserted under the skin of the subject,', 'wherein the sliding member is further configured to move within a second section of the straight track, and wherein the movement of the sliding member within the second section of the straight track causes the actuator to move in a proximal direction along the insertion axis,', 'wherein the second spring is configured to expand and retract the sharp in a proximal direction along the insertion axis while the distal end of the glucose sensor ...

Medical device inserters and processes of inserting and using medical devices

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter.

METHOD OF HARVESTING TISSUE USING SEQUENTIAL SECTIONS OF A TWO DIMENSIONAL ARRAY OF NEEDLES

In one aspect, the present disclosure relates to a method for harvesting biological tissue. In some embodiments, the method includes providing a device having a plurality of segments of hollow tubes, each hollow tube having at least one point at the distal end of the hollow tube, the plurality of segments forming a two dimensional array of hollow tubes, wherein each segment can include a plurality of hollow tubes; positioning the two dimensional array of hollow tubes proximal to an upper surface of a biological tissue; advancing a first segment of the two dimensional array of hollow tubes into the biological tissue to sever portions of the biological tissue from the surrounding tissue; raising the first segment of the two dimensional array of hollow tubes such that the biological tissue remains in each of the hollow tubes of the first segment; advancing a second segment of the two dimensional array of hollow tubes into the biological tissue to sever portions of the biological tissue from the surrounding tissue; and raising the second segment of the two dimensional array of hollow tubes such that the biological tissue remains in each of the hollow tubes of the second segment. 1. A method for harvesting biological tissue , the method comprising:providing a device having a plurality of segments of hollow tubes, each hollow tube comprising at least one point at the distal end of the hollow tube, the plurality of segments forming a two dimensional array of hollow tubes, wherein each segment comprises a plurality of hollow tubes;positioning the two dimensional array of hollow tubes proximal to an upper surface of a biological tissue;advancing a first segment of the two dimensional array of hollow tubes into the biological tissue to sever portions of the biological tissue from the surrounding tissue;raising the first segment of the two dimensional array of hollow tubes such that the biological tissue remains in each of the hollow tubes of the first segment;advancing a ...

MICRONEEDLE AND CHIP

A microneedle and a chip are disclosed for extraction fluids. The microneedle is provided on a substrate and comprises an elongated body extending from a distal end with a bevel to a proximal end on the substrate along a longitudinal axis. The elongated body comprises a capillary bore extending in a longitudinal direction thereof and defines a fluid path. The proximal end is integrally connected with the substrate and the capillary bore is in fluid communication with a fluid channel of the substrate. The cross-sectional area of the capillary bore in the distal end is larger than the cross-sectional area of the capillary bore in the proximal end. 1. A microneedle provided on a substrate , comprising: the elongated body comprises a capillary bore extending in a longitudinal direction thereof and defines a fluid path;', 'the proximal end is connected to the substrate and the capillary bore is in fluid communication with a fluid channel of the substrate;', 'wherein the cross-sectional area of the capillary bore comprises a triangular cross-section in a perpendicular direction relative the longitudinal direction of the microneedle., 'an elongated body extending from a distal end thereof with a bevel to a proximal end on the substrate along a longitudinal axis, wherein2. A microneedle according to claim 1 , wherein the triangular cross-section of the capillary bore further comprises at least one rounded corner.3. A microneedle according to claim 1 , wherein the triangular cross-section of the capillary bore comprises a convex base connected to straight sections via two rounded corners.4. A microneedle according to claim 1 , wherein the capillary bore comprises a hydrophilic surface.5. A microneedle according to claim 1 , wherein the fluid channel is configured to provide an under-pressure claim 1 , relative the atmospheric pressure claim 1 , to the capillary bore claim 1 , whereby fluid flow through the capillary bore is promoted.6. A microneedle according to claim 1 , ...

Microneedle template and microneedle prepared using the same

Provided are a microneedle template including: a substrate on which at least one microneedle shapes are formed; and a diamond layer formed on the surface of the at least one microneedle shapes, a method for preparing the microneedle template, a microneedle prepared using the microneedle template, and a method for preparing the microneedle.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 119-. (canceled)20. A glucose monitoring system comprising: the glucose sensor, wherein a distal end of the glucose sensor is configured to be inserted under skin of the subject;', 'a distal surface including an adhesive layer, wherein the distal surface is configured to be positioned on the skin of the subject such that the adhesive layer adheres to the skin of the subject;', 'an interior of the insertion assembly including a first spring in a loaded position, a second spring, a sliding member, and a straight track having a length, wherein the sliding member is configured to move only within the straight track; and', wherein the button is further configured to release the first spring from the loaded position upon being pressed, such that the first spring causes the sliding member to move within the straight track along a second axis different from the first axis, wherein the second axis is defined by the length of the straight track,', 'wherein movement of the sliding member within the straight track causes advancement of a sharp and the glucose sensor in a distal direction along an insertion axis different from the first axis and the second axis such that the distal end of the glucose sensor is inserted under the skin of the subject,', 'wherein the sliding member is further configured to continue moving within the straight track after the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis,', 'wherein the second spring is configured to expand and retract the sharp in a proximal direction along the insertion axis while the distal end of the glucose sensor remains under the skin of the subject, and wherein expansion of the second spring does not stop before the sliding member has stopped moving,', 'wherein the second spring is a compression spring, and', 'wherein the glucose sensor is ...

Medical device inserters and processes of inserting and using medical devices

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

Polymeric Microneedles and Rapid Additive Manufacturing of the Same

The invention generally relates to microneedle devices, methods of making same, pharmaceutical compositions comprising same, and methods of treating a disease comprising administering same. Specifically, the disclosed microneedle devices comprise a plurality of biocompatible microneedles having one or more of: (i) a curved, discontinuous, undercut, and/or perforated sidewall; (ii) a sidewall comprising a breakable support; and (iii) a cross-section that is non-circular and non-polygonal. The microneedles may also be tiered. Alternatively, the microneedles may be tiered. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present invention. 1. A microneedle device comprising:(a) a backing; and (i) a curved, discontinuous, undercut, and/or perforated sidewall;', '(ii) a sidewall comprising a breakable support; and', '(iii) a cross-section that is non-circular and non-polygonal,', 'and/or wherein the microneedles are tiered, and wherein the microneedles have a cross-sectional width that varies in both dimensions along at least a portion of their length., '(b) a plurality of biocompatible microneedles projecting from the backing, and wherein the microneedles comprise one or more of2. The device of claim 1 , wherein the microneedles have a tip diameter of less than about 10 micrometers.3. The device of claim 1 , wherein the backing and the microneedles comprise the same material.4. The device of claim 1 , wherein the backing and the microneedles comprise different materials.5. The device of claim 1 , wherein the microneedles comprise a curved claim 1 , discontinuous claim 1 , or undercut sidewall.6. The device of claim 1 , wherein the microneedles comprise a perforated sidewall.7. The device of claim 6 , wherein the sidewall is physically perforated.8. The device of claim 6 , wherein the sidewall is chemically perforated.9. The device of claim 1 , wherein the sidewall comprises a breakable ...

Methods and Structures for Assembling Lancet Housing Assemblies for Handheld Medical Diagnostic Devices

A method of assembling a lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is disclosed. The method includes forming a plurality of lancet structures in a lancet sheet. The lancet sheet has a removable ledge for releasing the lancet structures. The removable ledge of the lancet sheet is flexed for releasing the lancet structures from the removable ledge. 1. A lancet sheet providing multiple lancets for a lancet housing assembly for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient , the lancet sheet comprising:a removable ledge formed of material forming the lancet sheet;a plurality of lancet structures formed of material forming the lancet sheet, the plurality of lancet structures comprising a skin penetrating end and a blood transport portion adjacent the skin penetrating end, wherein the skin penetrating end is shaped and sized to penetrate the patient's skin at the skin site to provide an amount of blood; anda plurality of spring components formed of material that forms the lancet sheet that releasably connect the plurality of lancet structures to the removable ledge.2. The lancet sheet of claim 1 , wherein the plurality of spring components comprise:an attachment spring arm connected to a lancet structure of the plurality of lancet structures; anda ledge attachment arm that connects the attachment spring arm to the removable ledge.3. The lancet sheet of claim 2 , wherein the attachment spring arm is connected to the lancet structure by a lancet attachment arm claim 2 , wherein the lancet attachment arm is connected at a first end of the attachment spring arm claim 2 , the attachment spring arm being connected at a second opposite end to the ledge attachment arm.4. The lancet sheet of claim 3 , wherein the lancet attachment arm is connected to the lancet structure by a breakable finger.5. ...

ON-BODY MICROSENSOR FOR BIOMONITORING

A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor. 1. A method for manufacturing analyte sensing microneedles , the method comprising:removing material from needle bodies to form sharp tips of microneedles; andforming at least one layer along at least one of the sharp tips of a respective one of the microneedles, which has an electrically conductive inner portion and an electrically insulating material surrounding the electrically conductive inner portion, wherein the at least one layer is configured to detect at least one analyte in interstitial fluid when the microneedles are positioned within a user's skin.2. The method of claim 1 , wherein the electrically conductive inner portion defines an active region between the electrically insulating material and an apex of the at least one of the sharp tips claim 1 , wherein the at least one layer extends along the active region.3. The method of claim 1 , wherein the electrically insulating material is an oxide layer.3. The method of claim 1 , wherein forming the at least one layer includes applying a plurality of layers to a sloped surface of the at least one of the sharp tips.4. The method of claim 1 , wherein the at least one layer extends along a sloped region of the ...

ON-BODY MICROSENSOR FOR BIOMONITORING

A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor. 1. A multi-filament sensor for sensing at least one analyte in a body fluid of a user , the multi-filament sensor comprising:a substrate; and a conductive columnar core including a tip region;', 'an insulating material surrounding the conductive columnar core and exposing an active region at the tip region; and', 'at least one layer at the tip region, wherein the at least one layer is configured to generate an electronic signal in a presence of a concentration of at least one analyte present in the body fluid, wherein the at least one layer is in communication with the active region such that the electronic signal is transmitted through the conductive columnar core., "an analyte-sensing filament connected to the substrate and configured for insertion into the user's skin, wherein the analyte-sensing filament includes:"}2. The multi-filament sensor of claim 1 , wherein the at least one sensing layer overlays conductive material of the conductive columnar core between a distal tip of the analyte-sensing filament and the insulating material.3. The multi-filament sensor of claim 1 , wherein the at least one layer includes a sensing layer claim 1 , a conductive layer claim ...

RAPID DELIVERY AND/OR RECEIVING OF FLUIDS

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus. For example, blood may be received from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. In another aspect, the present invention is generally directed to arrangements of skin insertion objects such as microneedles and methods of forming and arranging skin insertion objects. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like. 137-. (canceled)38. A microneedle structure comprising:an annular ring having an inner circumference and an outer circumference; anda first plurality of microneedles that each includes a base portion and a penetrating portion, the base portions of the first plurality of microneedles lying in a plane and arranged in a circular configuration at the outer circumference of the annular ring, the penetrating portions of the first plurality of microneedles extending in a direction ...

SENSOR MODULE WITH ENHANCED CAPILLARY FLOW

A sensor module is disclosed herein. The sensor module includes a main housing defining an analysis zone within the housing. The sensor module also includes a skin piercing member mounted within the main housing. The skin piercing member is movable relative to the main housing between a retracted position and an extended position. The main housing of the sensor module defines a fluid sample flow passage that extends from a sampling end of the main housing to the analysis zone. The fluid sample flow passage includes a funnel structure through which the skin piecing member extends when in the extended position. The fluid sample flow passage also includes capillary flow enhancing slots that extend outwardly from opposite sides of the funnel structure. 1. (canceled)2. A sensor module comprising:a main housing defining an analysis zone within the housing;a skin piercing member mounted within the main housing, the skin piercing member being movable relative to the main housing between a retracted position and an extended position;first and second electrodes positioned at the analysis zone, at least one of the electrodes including analyte sensing chemistry, the analysis zone being sealed to limit a degree to which the sensing chemistry is exposed to air.3. The sensor module of claim 2 , further comprising a fluid sample flow passage that extends from an exterior of the main housing to the analysis zone.4. The sensor module of claim 3 , where the skin piercing member passes through the fluid sample flow passage when in the extended position.5. The sensor module of claim 4 , further comprising a sealing member affixed to the exterior of the main housing which covers the fluid sample flow passage.6. The sensor module of claim 5 , wherein the skin piercing member pierces the sealing member when the skin piercing member is moved to the extended position.7. A sensor module comprising:a main housing defining an analysis zone within the housing, the main housing having a sampling ...

Method and System for Harvesting Biological Tissue

In one aspect, the dual bevel needle can include a hollow tube having a proximal end, a distal end, a first lateral side, and a second lateral side opposite the first lateral side; a first needle point at the distal end of the hollow tube; a second point at the distal end of the hollow tube; a first bevel on each of the first lateral side and the second lateral side, the first bevel comprising a first bevel angle relative to a longitudinal axis of the tube; and a second bevel on each of the first lateral side and the second lateral side, the second bevel having a second bevel angle relative to the longitudinal axis of the tube, wherein the first and second bevels each form a portion of an ellipse, the ellipse having an inner cutting edge and terminating in the first and second needle points at the distal end of the tube, the second bevel angle being shallower than the first bevel angle, the second bevel being located adjacent the proximal end of the first bevel, and the inner cutting edge converging to a narrow heel.

Polymeric Microneedles and Rapid Additive Manufacturing of the Same

The invention generally relates to microneedle devices, methods of making same, pharmaceutical compositions comprising same, and methods of treating a disease comprising administering same. Specifically, the disclosed microneedle devices comprise a plurality of biocompatible microneedles having one or more of: (i) a curved, discontinuous, undercut, and/or perforated sidewall; (ii) a sidewall comprising a breakable support; and (iii) a cross-section that is non-circular and non-polygonal. The microneedles may also be tiered. Alternatively, the microneedles may be tiered. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present invention. 1. A microneedle device comprising:(a) a backing; and (i) a curved, discontinuous, undercut, and/or perforated sidewall;', '(ii) a sidewall comprising a breakable support; and', '(iii) a cross-section that is non-circular and non-polygonal,', 'and/or wherein the microneedles are tiered, and wherein the microneedles have a cross-sectional width that varies in both dimensions along at least a portion of their length., '(b) a plurality of biocompatible microneedles projecting from the backing, and wherein the microneedles comprise one or more of2. The device of claim 1 , wherein the microneedles have a tip diameter of less than about 10 micrometers.3. The device of claim 1 , wherein the backing and the microneedles comprise the same material.4. The device of claim 1 , wherein the backing and the microneedles comprise different materials.5. The device of claim 1 , wherein the microneedles comprise a curved claim 1 , discontinuous claim 1 , or undercut sidewall.6. The device of claim 1 , wherein the microneedles comprise a perforated sidewall.7. The device of claim 6 , wherein the sidewall is physically perforated.8. The device of claim 6 , wherein the sidewall is chemically perforated.9. The device of claim 1 , wherein the sidewall comprises a breakable ...

Medical device inserters and processes of inserting and using medical devices

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter. 1. An apparatus for inserting a medical device through the skin of a subject , which comprises:a sheath defining a distal surface for placement on the skin of the subject;a device support movable between a proximal and distal position, and adapted to support the medical device, the device support comprising a first engagement member for releasably coupling the device support to the sharp support and a second engagement member for engaging the medical device;a sharp support movable between a proximal and a distal position and adapted to support a sharp for inserting the medical device into the skin of the subject and extending through a portion of said device support, a handle movable between a proximal position and a distal position relative to the sheath and adapted to urge the device support and the sharp support from a proximal to a distal position to insert the sharp into the skin of the subject; anda driver for advancing the sharp support towards the proximal position when the sharp support reaches the distal position.2. The apparatus of claim 1 , wherein the handle and sheath comprise an interlocking configuration which prevents relative movement of the handle with respect to the sheath which is overcome by a force applied to the handle.3. The apparatus of claim 1 , wherein the second engagement member comprises one or more movable arms for engaging the device.4. The apparatus of claim 3 , wherein the one or more movable arms are normally biased in a position spaced apart from the medical device.5. The apparatus of claim 4 , wherein the one or more movable arms are ...

COAXIAL MICRONEEDLE ASSEMBLIES AND METHODS THEREOF

The present invention is directed to devices including one or more hollow needles and a transducing wire disposed within at least one needle. In particular instances, arrays of such needles can be employed. Methods for fabricating and using such devices are also disclosed herein. 1. A device comprising:a hollow needle, wherein the needle has an interior surface facing a hollow lumen and an exterior surface, a distal end of the exterior surface comprises a puncturing edge, and the needle has a length of more than about 0.5 mm and/or a width or diameter of less than about 1 mm;at least one transducing wire disposed within the lumen of the needle; andan insulating layer disposed within at least a portion of a surface of the lumen and/or upon at least a portion of a surface of the transducing wire.2. The device of claim 1 , wherein the puncturing edge of the needle comprises a needle face claim 1 , wherein the transducing wire comprises a wire face disposed at a distal end claim 1 , and wherein a plane of the needle face and a plane of the wire face are sufficiently parallel.3. The device of claim 1 , wherein the insulating layer is disposed upon the surface of the transducing wire.4. The device of claim 1 , wherein the insulating layer is disposed within the surface of the lumen.5. The device of claim 1 , further comprising a conductive component providing an electrical connection to the transducing wire.6. The device of claim 5 , wherein the conductive component comprises a carbon-based paste or a conductive polymer.7. The device of claims 1 , wherein a distal end of the transducing wire comprises an exposed surface.8. The device of claim 7 , wherein the exposed surface is conductive and optionally comprises one or more electrochemical modifications.9. The device of claim 7 , further comprising a conductive component disposed on the exposed surface of the transducing wire claim 7 , wherein the conductive component optionally comprises one or more entrapped capture ...

Biological test kit

The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet.

METHOD FOR THE MASK-ETCHING OF A PIERCING ELEMENT

A method is disclosed for the mask-etching of a piercing element having an elongate shaft, a distally protruding tip, a proximal holding part, and a laterally open collecting channel that collects bodily fluid and extends along the shaft as far as the area of the tip, wherein a side of a double-sided etching mask is applied respectively to the two sides of a substrate and, under the action of an etching agent, the piercing element is formed as a part made by chemical blanking, wherein a channel side of the etching mask is provided with a channel etching slit for unilateral etching of the collecting channel. 1. A piercing element comprising an elongate shaft , a distally protruding tip , a proximal holding part , and a laterally open collecting channel configured for collecting bodily fluid and extending along the elongate shaft as far as the area of the tip , wherein the collecting channel , at least at one of its end portions , extends with a continuously decreasing cross-sectional area and is formed by a mask-etching method in which a double-sided etching mask is applied to two sides of a substrate and , under the action of an etching agent , the piercing element is formed as a part made by chemical blanking , wherein a channel side of the double-sided etching mask is provided with a channel etching slit for unilateral etching of the collecting channel , wherein the channel etching slit has a proximal end portion and a distal end portion located opposite the proximal end portion , wherein the proximal and/or distal end portion of the channel etching slit is configured to taper toward the end of the channel etching slit.2. The piercing element of claim 1 , wherein the double-sided etching mask is provided with a flange-forming area claim 1 , which adjoins the channel etching slit in a proximal direction claim 1 , and the flange-forming area is undercut to form a flange edge forming a mouth of the collecting channel.3. The piercing element of claim 2 , wherein the ...

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter. 125-. (canceled)26. A glucose monitoring assembly , the assembly comprising:(1) an inserter comprising a sharp configured to insert a portion of a transcutaneous glucose sensor into a subject; and an on body electronics unit housing comprising a plurality of recesses disposed on a periphery of the on body electronics unit housing;', 'the transcutaneous glucose sensor; and', 'on body electronics coupled with the transcutaneous glucose sensor, wherein the on body electronics is disposed in the on body electronics unit housing,, '(2) an on body electronics unit, comprising advance the on body electronics unit and the sharp from a proximal position entirely within the inserter to a distal position such that the sharp pierces skin of the subject and the on body electronics unit housing is secured to the skin of the subject in the distal position,', 'automatically retract the sharp from the distal position to a retracted position entirely within the inserter,, 'wherein the inserter is configured towherein the plurality of recesses is detachably engaged with the inserter when the on body electronics unit and the sharp are in the proximal position,wherein the on body electronics unit housing further comprises a top surface and a bottom surface, wherein the top surface comprises an aperture of the top surface and the bottom surface comprises an aperture of the bottom surface, and wherein the sharp extends through the aperture of the bottom surface when the on body electronics unit and the sharp are in the proximal position, andwherein the inserter further comprises a distal end ...

On-body microsensor for biomonitoring

A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

MICROBIOPSY DEVICE

A microbiopsy device for taking biological samples, comprising a body including two or more cutting elements for cutting tissue to form a biological sample; and a chamber inside the body for receiving and retaining the biological sample, the chamber having an opening between the cutting elements, wherein the cutting elements are arranged to cut a section of tissue having a width of less than 1 mm. 141.-. (canceled)42. A microbiopsy device for taking biological samples , comprisinga body including two or more cutting elements for cutting tissue to form a biological sample; anda chamber inside the body for receiving and retaining the biological sample, the chamber having an opening between the cutting elements, wherein the cutting elements are arranged to cut a section of tissue having a width of less than 1 mm.43. The microbiopsy device of claim 42 , wherein the two or more opposed cutting elements together define at least one cutting edge claim 42 , preferably a substantially continuous cutting edge.44. The microbiopsy device of claim 42 , wherein the two or more opposed cutting elements are arranged to cut a section of tissue having a width less than 750 microns claim 42 , preferably less than 500 microns claim 42 , more preferably less than 400 microns claim 42 , more preferably less than 300 microns claim 42 , more preferably less than 200 microns claim 42 ,45. The microbiopsy device of claim 42 , wherein the section of tissue is non circular.46. The microbiopsy device of claim 42 , comprising an assembly of at least two plates claim 42 , wherein each cutting element is defined by a respective tapered section of one of said plates.47. The microbiopsy device of claim 46 , wherein the chamber is defined by one or more recesses in the plates.48. The microbiopsy device of claim 42 , wherein the chamber retains the biological sample therein by friction.49. The microbiopsy device of claim 42 , further including retaining elements to retain the biological sample therein ...

CATHETER

A catheter and associated method for taking a plurality of samples from within a length of a blood vessel. The catheter includes an elongate central body arranged to be inserted into and positioned along a central region of a blood vessel. A plurality of collection areas are defined along the elongate central body for collecting samples at the central region of the blood vessel. A plurality of mixers are provided radially outwardly of the elongate central body and arranged to create a flow of blood from a boundary layer at a wall of the blood vessel to the elongate central body. This enables the collection areas to collect samples from the boundary layer. 1. A method of sampling blood in vivo from within a length of a blood vessel , the method comprising:introducing a vascular catheter into a blood vessel over a guidewire, the vascular catheter having an elongate body section provided with a plurality of longitudinally spaced blood collection ports for collecting discrete blood samples within the body of the catheter;deploying a static mixer, positioned upstream of at least one blood collection port, radially outwardly of the elongate body section to create a flow of blood from a boundary layer at a wall of the blood vessel around the periphery of the blood vessel, thereby to mix blood; and,collecting discrete samples of mixed blood at the plurality of blood collection ports for subsequent analysis.215. A method according to claim , further comprising deploying a plurality of static mixers by locating each of the plurality of static mixers upstream of at least one blood collection port.3. A method according to claim 1 , further comprising analysing the discrete blood samples collected by the respective blood collection ports to determine a data profile of the concentration levels of one or more biomarkers along the length of the blood vessel.4. A method according to claim 1 , wherein said deploying a catheter comprises deploying a catheter to have a plurality of ...

RAPID DELIVERY AND/OR RECEIVING OF FLUIDS

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus. For example, blood may be received from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. In another aspect, the present invention is generally directed to arrangements of skin insertion objects such as microneedles and methods of forming and arranging skin insertion objects. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like. 137-. (canceled)38. A microneedle structure comprising:a first plurality of microneedles that each includes a base portion and a penetrating portion, the base portions of the first plurality of microneedles being arranged at the periphery of a first closed loop lying in a plane, the penetrating portions of the first plurality of microneedles each being bent upwardly from the plane and extending at a respective angle away from the plane of the first closed loop,wherein the ...

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 1. An apparatus for inserting a medical device through the skin of a subject , which comprises: a sheath defining a distal surface for placement on the skin of the subject;', 'a handle movable between a proximal position and distal position;', 'a device support for supporting the medical device and defining an aperture therethrough, the device support coupled to the handle;', 'a sharp support for supporting a sharp extending through said aperture and coupled to the device support; and', 'a first driver for biasing the sharp support towards the proximal position; and, 'a first subassembly comprising'} a housing configured for removable attachment to the first subassembly; and', 'a second driver for advancing the sharp support towards the distal position., 'a second subassembly comprising'}2. The apparatus of claim 1 , wherein the second driver comprises a rotatable cam.3. The apparatus of claim 1 , wherein the second driver comprises a torsion spring.4. The apparatus of claim 1 , wherein the second driver comprises an axial driver and a crank assembly.5. The apparatus of claim 1 , wherein the second driver comprises a compression spring.6. The apparatus of claim 1 , wherein the handle is at least partially disposed surrounding the sheath.7. The apparatus of claim 1 , further comprising a bellows portion disposed between the sheath and the handle.8. The apparatus of claim 1 , further comprising a retention member for retaining the device support in the distal position.9. The apparatus of claim 1 , wherein the device support is coupled to the handle until the device support reaches a distal position.10. The apparatus of claim 1 , further comprising a second driver for biasing the device support towards the distal position.11. An apparatus for inserting a medical device at least partially through the skin of a subject claim 1 , which ...

Method for the mask-etching of a piercing element

A method is disclosed for the mask-etching of a piercing element having an elongate shaft, a distally protruding tip, a proximal holding part, and a laterally open collecting channel that collects bodily fluid and extends along the shaft as far as the area of the tip, wherein a side of a double-sided etching mask is applied respectively to the two sides of a substrate and, under the action of an etching agent, the piercing element is formed as a part made by chemical blanking, wherein a channel side of the etching mask is provided with a channel etching slit for unilateral etching of the collecting channel. 1. A method for the mask-etching of a piercing element comprising an elongate shaft , a distally protruding tip , a proximal holding part , and a laterally open collecting channel that collects bodily fluid and extends along the shaft as far as the area of the tip , in which method a double-sided etching mask is applied to the two sides of a substrate and , under the action of an etching agent , the piercing element is formed as a part made by chemical blanking , wherein a channel side of the etching mask is provided with a channel etching slit for unilateral etching of the collecting channel , wherein a proximal and/or distal end portion of the channel etching slit is configured to taper toward the end of the slit.2. The method of wherein the proximal and/or distal end portion of the channel etching slit tapers linearly claim 1 , such that the etched collecting channel extends in the direction of the taper with a constant or continuously decreasing cross-sectional area.3. The method of wherein the channel etching slit in a proximal region of the etching mask is positioned such that the etched collecting channel opens out at the front end of the holding part.4. The method of wherein the etching mask is provided with a flange-forming area claim 1 , which adjoins the channel etching slit in the proximal direction claim 1 , and the flange-forming area is undercut to ...

ON-BODY MICROSENSOR FOR BIOMONITORING

A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor. 1a substrate; and [ a base end coupled to the substrate,', 'a columnar protrusion having a proximal portion coupled to the base end and a distal portion, and', 'a tip region coupled to the distal portion of the columnar protrusion and configured to provide access to the body fluid of the user;, 'a substrate core including, 'a conductive layer, isolated to the tip region of the substrate core and away from the base end as an active region that enables transmission of electronic signals generated upon detection of an analyte within the body fluid;', 'an insulating layer surrounding the substrate core and exposing a portion of the conductive layer, thereby defining a boundary of the active region; and', 'a sensing layer, in communication with the active region, configured for at least one of amperometric sensing and potentiometric sensing of the analyte., 'a filament including. A sensor for sensing analytes present in a body fluid of a user, the sensor comprising: This application is a continuation of U.S. patent application Ser. No. 14/876,692 filed 6 Oct. 2015, which is a continuation of U.S. patent application Ser. No. 14/211,404, filed 14 Mar. 2014, which claims the ...

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter. 125-. (canceled)26. A glucose monitoring assembly , the assembly comprising: an inserter housing; and', 'a sharp carrier assembly disposed in the inserter housing, wherein the sharp carrier assembly comprises a sharp configured to insert a portion of a glucose sensor into a subject;, '(1) an inserter, comprising an on body electronics unit housing comprising a top surface and a bottom surface, wherein the top surface comprises a first aperture, the bottom surface comprises a second aperture, and wherein a passageway extends through the on body electronics unit between the first aperture and the second aperture;', 'the glucose sensor; and', 'on body electronics coupled with the glucose sensor, wherein the on body electronics are disposed within the on body electronics unit housing, and wherein the on body electronics comprise a processor, memory, a power supply, and wireless communication circuitry configured to wirelessly communicate data indicative of a glucose level,, '(2) an on body electronics unit, comprisingwherein the sharp carrier assembly is directly and removably engaged with the on body electronics unit housing at a location external to the passageway, advance the sharp carrier assembly and the on body electronics unit from a proximal position within the inserter housing to a distal position,', 'cause the sharp to insert the portion of the glucose sensor into the subject, and', 'retract the sharp carrier assembly from the distal position to a retracted position within the inserter housing, and, 'wherein the inserter is configured towherein the sharp extends through ...

APPARATUS AND METHODS FOR DRUG DELIVERY USING MICRONEEDLES

A microneedle has a proximal end portion and a distal end portion and defines a lumen. The proximal end portion is configured to be coupled to a cartridge to place the lumen in fluid communication with the cartridge. The proximal end portion includes a base surface that is configured to be placed in contact with a surface of a target tissue. The distal end portion of the microneedle includes a beveled surface. The beveled surface defines a tip angle of less than about 20 degrees and a ratio of a bevel height to a bevel width of less than about 2.5. 1. An apparatus , comprising:a microneedle having a distal end portion and a proximal end portion, and defining a lumen, the proximal end portion configured to be coupled to a cartridge to place the lumen in fluid communication with the cartridge, the proximal end portion including a base surface configured to contact a surface of a target tissue,the distal end portion including a beveled surface, the beveled surface defining a first bevel angle and a second bevel angle different than the first bevel angle.2. The apparatus of claim 1 , wherein the first bevel angle is less than the second bevel angle.3. The apparatus of claim 1 , wherein the first bevel angle is less than 20 degrees and the second bevel angle is greater than the first bevel angle.4. The apparatus of claim 1 , wherein:the first bevel angle is a tip angle; andthe second bevel angle is an inside angle.5. The apparatus of claim 1 , wherein a ratio of a bevel height to a bevel width is less than about 2.5.6. The apparatus of claim 1 , wherein the first bevel angle is less than about 18 degrees.7. The apparatus of claim 1 , wherein the first bevel angle is less than about 12 degrees.8. The apparatus of claim 1 , wherein the second bevel angle is greater than about 45 degrees.9. The apparatus of claim 1 , wherein at least a portion of the bevel surface is curved.10. The apparatus of claim 1 , wherein:a bevel height is less than about 500 μm; anda bevel width is ...

CATHETER

A catheter and associated method for taking a plurality of samples from within a length of a blood vessel. The catheter includes an elongate central body arranged to be inserted into and positioned along a central region of a blood vessel. A plurality of collection areas are defined along the elongate central body for collecting samples at the central region of the blood vessel. A plurality of mixers are provided radially outwardly of the elongate central body and arranged to create a flow of blood from a boundary layer at a wall of the blood vessel to the elongate central body. This enables the collection areas to collect samples from the boundary layer. 1. A method of sampling blood in vivo from within a length of a blood vessel , the method comprising:introducing a vascular catheter into a blood vessel over a guidewire, the vascular catheter comprising an elongate body section provided with a plurality of longitudinally spaced blood collection ports for collecting discrete blood flow samples within the body of the catheter;deploying at least a first plurality of mixing elements, at successive elongate positions upstream of at least a first one of the plurality of blood collection ports, radially outwardly of the elongate body section to divert blood flow circumferentially around the blood vessel, the first plurality of mixing elements respectively being deployed at a number of different radial positions around the elongate body section to interfere with different parts of the blood flow's cross section so as to mix the blood flow; and thencollecting the discrete blood flow samples at the plurality of blood collection ports at the same time for subsequent analysis.2. The method of claim 1 , wherein the deploying comprises deploying the first plurality of mixing elements such that circumferentially diverted blood flow from each mixing element claim 1 , except the blood flow circumferentially diverted from the most downstream of the first plurality of mixing ...

LANCET DEVICE WITH FLEXIBLE COVER

The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet. 1. A biological test kit comprising: a) a rigid first layer; b) one or more lancets secured to the first layer , said lancets each having a sharp region disposed substantially away from the first layer; c) one or more second layers disposed in an opposed arrangement relative to the first layer , the first and second layers being arranged to form one or more cavities there-between , each of the one or more second layers forming one or more covers , each cover over one of the lancets; and d) each of the one or more covers having a first unconstrained configuration in which the lancet sharp region does not protrude past or through the cover and having a second compressed configuration in which the lancet sharp region protrudes through the cover.2. The biological test kit of wherein said covers are resilient such that the cover can pass from the unconstrained configuration to the compressed configuration when a compression force is applied and return from the compressed configuration to the unconstrained configuration when said compression force is removed.3. The biological test kit of further comprising: a) at least one chemical test strip for capturing biological samples.4. The biological test kit of further comprising a testing apparatus for testing one or more chemical properties of biological samples present on said test strip.5. A biological test kit comprising: a) a rigid first layer claim 3 , b) one or more lancets secured to the first layer claim 3 , said lancets each having a sharp region ...

Hollow microneedle with bevel opening

An article having at least one microneedle ( 160, 260 ) is provided. The microneedle includes a base ( 162 ), an elongated body ( 161 ) having a central axis ( 130 ) and a body diameter ( 168 ), a tip portion ( 166 ), a first channel ( 170 ), and a second channel ( 176 ). The tip portion includes a tip ( 164 ), a beveled surface ( 140 ), and a bevel opening ( 172 ) in the beveled surface. The first channel extends axially from the bevel opening through at least a portion of the elongated body and has a first wall that is substantially aligned with the central axis. The second channel extends radially from the first channel to the bevel opening and has a second wall that is oriented substantially orthogonal to the central axis. The first channel and second channel merge to form the bevel opening.

Vascular access blood collection devices and related methods

The present disclosure is directed to a needle assembly for drawing blood. The needle assembly can be a standalone or part of an over-the-needle medical device, such as an intravenous catheter. A blood collection device is attached directly or indirectly to the needle hub of the needle assembly and/or to a catheter hub, such as through a Y-site or adaptor connected to a tubing that is connected to the catheter hub. The needle is configured to access the vascular system to draw blood, which then passes to the blood collection device via the needle lumen, which has a tip having a discontinuity opening, an opening with a movable stem, or a shaft element with a lumen.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 119-. (canceled)20. An insertion assembly for inserting a glucose sensor into a subject , the insertion assembly comprising:the glucose sensor, wherein a distal end of the glucose sensor is configured to be inserted under skin of the subject;a distal surface comprising an adhesive layer, wherein the distal surface is configured to be positioned on the skin of the subject such that the adhesive layer adheres to the skin of the subject;an interior of the insertion assembly comprising a first spring in a loaded position, a second spring, a rotatable element, a sliding element, and a straight track having a length, wherein the sliding element is configured to move only within the straight track; and wherein the button is further configured to release the first spring from the loaded position upon being pressed, such that the first spring causes the sliding element to move within the straight track,', 'wherein movement of the sliding element within the straight track causes advancement of a sharp and the glucose sensor in a distal direction along an insertion axis different from the depression axis such that the distal end of the glucose sensor is inserted under the skin of the subject,', 'wherein the sliding element is further configured to continue moving within the straight track after the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis,', 'wherein the second spring is configured to expand and retract the sharp in the proximal direction along the insertion axis while the distal end of the glucose sensor remains under the skin of the subject,', 'wherein the sharp is configured to be retracted fully within the interior of the insertion assembly,', 'wherein the insertion assembly comprises a maximum height parallel with the insertion axis and a maximum width parallel with the length of the ...

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 119-. (canceled)20. An insertion assembly for inserting a glucose sensor into a subject , the insertion assembly comprising:the glucose sensor, wherein a distal end of the glucose sensor is configured to be inserted under skin of the subject;a distal surface comprising an adhesive layer, wherein the distal surface is configured to be positioned on the skin of the subject such that the adhesive layer adheres to the skin of the subject;an interior of the insertion assembly comprising a first spring in a loaded position, a second spring, a sliding element, an actuator, and a straight track having a length, wherein the sliding element is configured to move within the straight track; and wherein the button is further configured to release the first spring from the loaded position upon being pressed, such that the first spring causes the sliding element to move within the straight track,', 'wherein movement of the sliding element within the straight track causes advancement of a sharp and the glucose sensor in a distal direction along an insertion axis different from the depression axis such that the distal end of the glucose sensor is inserted under the skin of the subject,', 'wherein the sliding element is further configured to continue moving within the straight track after the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis,', 'wherein the sliding element is further configured to apply a force on the actuator in a proximal direction along the insertion axis after the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis,', 'wherein the second spring is configured to expand and retract the sharp in the proximal direction along the insertion axis while the distal end of the glucose sensor remains under the skin of the subject,', 'wherein the sharp ...

Lancet device with flexible cover

The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet.

MEDICAL DEVICES WITH RETRACTABLE NEEDLE AND RELATED METHODS

Needle safety assemblies and related methods are disclosed. Exemplary needle safety assemblies include a needle with a sharpened tip attached directly or indirectly to an elongate tube having a proximal end that is constrained from proximal axial movement. An elongate shield with a distal end opening and a body extends over at least a portion of the elongate tube. 1. A needle safety assembly , comprising:a needle with a sharpened tip attached directly or indirectly to a flexible tube portion having a proximal end that is constrained from proximal axial movement;an elongate shield comprising a distal end opening and a body with a lumen extending over at least a portion of the flexible tube portion with the distal end opening spaced a first distance from the sharpened tip in a needle extended position;a needle holder coupled directly or indirectly to the elongate shield and fixed axially relative to the elongate shield; said needle holder comprising a proximal opening sized and shaped to receive a sampling device; anda tab comprising a pin extending radially outwardly from within the lumen of the elongate shield and through a slot formed with the elongate shield, the tab being movable in a proximal direction to retract the needle tip in the proximal direction.2. The needle safety assembly of claim 1 , wherein the flexible tube portion is located between a first end defined by the pin on the tab and a distal end of the needle holder claim 1 , said flexible tube portion has a weakened portion that shrinks in length when a compressive force is imparted by the tab.3. The needle safety assembly of claim 1 , wherein an end axially aligned with the flexible tube portion is pressed fit within a bore of the needle holder and fixedly secured thereto.4. The needle safety assembly of claim 1 , further comprising a socket assembly attached to the needle holder and the elongate shield.5. The needle safety assembly of claim 1 , further comprising a vacutainer positioned in a ...

Medical Device For Analyte Monitoring And Drug Delivery

The invention relates to an ingestible, implantable or wearable medical device comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical parameter data of an interaction between the disease marker biological analyte with the bioactive agent; a biometric recognition device capable of comparing the physical parameter data with an analyte interaction profile; optionally a therapeutic agent releasing device capable of controlling release of the therapeutic agent from the reservoirs; an interface device capable of facilitating communications between the microarray scanning device, biometric recognition device and the therapeutic agent releasing device; and an energy source to power the medical device. Specifically, the invention relates to a medical device capable of detecting an analyte in a bodily fluid comprising at least one microneedle capable of obtaining a sample of a bodily fluid, a first microchannel through which the sample flows and is in fluid communication with the at least one microneedle, a second microchannel in fluid communication with the first microchannel, through which a buffer flows, wherein the second channel comprises a microarray with a bioactive agent, a microarray scanning device to detect an interaction between the bioactive agent and the analyte in the bodily fluid; and an interface device. 123-. (canceled)24. An ingestible medical device , comprising:a microchip enclosed in the ingestible medical device, the microchip comprising an interface device that is configured to wirelessly transmit a signal that is generated upon interaction of the device with gastric fluid to an external device located outside the subject, and is configured to transmit ...

Systems and Methods of Sample Processing and Fluid Control in a Fluidic System

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

LANCET NEEDLE WITH ALIGNMENT AND RETENTION NOTCH

A lancet needle with an alignment and engagement notch, with material of the lancet body extending into the notch to more securely retain the needle to the lancet body, whereby a shorter needle can be utilized than with typical lancets. The notch optionally also provides a registration point for rotational and/or axial alignment of the needle during overmolding to form the lancet body, for example to maintain consistent positioning of the needle's beveled point. 1. A lancet comprising:{'sub': 'B', 'a lancet body having a length Land comprising a head portion and a body portion;'}{'sub': N', 'B', 'M', 'B, 'a lancing needle having a length Lno more than 75% the lancing body length Land comprising an elongate needle body, an embedded portion having length Lno more than 50% the lancet body length L, a sharp tip exposed from the head portion of the lancet body opposite the body portion, and a notch, wherein the embedded portion is embedded within the lancet body;'}wherein the notch is formed at least partially on the embedded portion; andwherein the sharp tip is formed on an end of the elongate needle body opposite the embedded portion.2. The lancet of claim 1 , wherein the head portion is positioned at a first end of the lancet body and the body portion extends perpendicularly from the center of the head portion towards a second end of the lancet body.3. The lancet of claim 2 , wherein the lancet head portion comprises a circular disk-like member and the lancet body portion comprises a generally oblong member having a first substantially flat side and a second substantially flat side opposite the first side.4. The lancet of claim 1 , wherein the needle body defines a thickness and the notch defines a notch depth of less than one-half the needle body thickness.5. The lancet of claim 1 , wherein the elongate needle body extends along a longitudinal axis.6. The lancet of claim 1 , wherein the notch defines a notch axis generally transverse to the longitudinal axis of the ...

PLASTIC BLOOD LANCET

The present invention provides a surgically invasive pointed article for skin penetration and capillary whole blood extraction whose penetration ability can be disabled after use by deforming the tips. The present invention is made by injection moulding a plastic needle having an anchoring means using a first material, followed by another injection moulding process to over-mould a first body segment and second body segment using a second material to encase the plastic needle thereby anchoring the plastic needle to prevent further movement of the plastic needle The encasing of the second material provide a barrier isolating the plastic needle from the ambient to protect the tips from damage and once sterilized, to conserve the sterile conditions till point of use. The barrier formed by a second over-moulding process comprises a detachable cap and a body The present invention is normally used for blood sampling applications but can also be used for applications such as vaccination or skin allergy testing, and transdermal/intradermal drug delivery. 1. A plastic blood lancet comprisinga) A plastic needle made from a first material that has a glass transition temperature,b) A first body segment, andc) A second body segment, both the first and the second body segment are made from a second material at the same time, and which has a melting temperature that is lower than the glass transition temperature of the first material, and which does not form covalent bonding or have chemical reaction with the first material.2. A plastic blood lancet in claim 1 , wherein the plastic needle further comprisingi) a hole portion for anchoring the plastic needle onto the second body segment,ii) a rectangular section for providing a sliding means for the first body segment to be pulled of linearly, and for preventing the first body segment to be twisted,iii) a needle tip, andiv) an apex, of which the taper angle is much larger than the needle tip.3. A plastic blood lancet in claim 1 , ...

APPARATUS AND METHODS FOR DRUG DELIVERY USING MICRONEEDLES

A microneedle has a proximal end portion and a distal end portion and defines a lumen. The proximal end portion is configured to be coupled to a cartridge to place the lumen in fluid communication with the cartridge. The proximal end portion includes a base surface that is configured to be placed in contact with a surface of a target tissue. The distal end portion of the microneedle includes a beveled surface. The beveled surface defines a tip angle of less than about 20 degrees and a ratio of a bevel height to a bevel width of less than about 2.5. 129-. (canceled)30. An apparatus , comprising:a housing, a proximal end portion of the housing defining an opening configured to receive a portion of a medicament container therein, a distal end portion of the housing including a base surface configured to contact a surface of a target tissue; anda microneedle coupled to the distal end portion of the housing, a proximal end portion of the microneedle in fluid communication with the medicament container when the portion of the medicament container is disposed within the opening, a distal end portion of the microneedle including a beveled surface that defines (1) a first segment arranged at a first angle relative to a centerline of a lumen defined by the microneedle, and (2) a second segment arranged at a second angle relative to the centerline, the first angle being different than the second angle, the first segment having a length different than a length of the second segment.31. The apparatus of claim 30 , wherein the microneedle is fixedly coupled to the base surface such that the microneedle has a length extending beyond the base surface of about 900 microns.32. The apparatus of claim 30 , wherein:the base surface is normal to the centerline; andthe microneedle is fixedly coupled to the base surface such that the microneedle has a length extending beyond the base surface of about 900 microns.33. The apparatus of claim 30 , wherein the beveled surface defines a first ...

Intra-mold sterilization of plastic-embedded needle

Methods for intra-mold sterilization of a plastic-embedded metal component of a product, such as a medical lancet having a metal needle embedded within a plastic lancet body. For example, a lancet needle is retained within a mold, plastic is injected to encapsulate the needle, and a specified minimum temperature is maintained for a specified minimum cycle time. In example forms, the specified minimum mold temperature is at least about 370 degrees Fahrenheit and the specified minimum cycle time is at least about 10 seconds.

Method and System for Harvesting Biological Tissue

In one aspect, the dual bevel needle can include a hollow tube having a proximal end, a distal end, a first lateral side, and a second lateral side opposite the first lateral side; a first needle point at the distal end of the hollow tube; a second point at the distal end of the hollow tube; a first bevel on each of the first lateral side and the second lateral side, the first bevel comprising a first bevel angle relative to a longitudinal axis of the tube; and a second bevel on each of the first lateral side and the second lateral side, the second bevel having a second bevel angle relative to the longitudinal axis of the tube, wherein the first and second bevels each form a portion of an ellipse, the ellipse having an inner cutting edge and terminating in the first and second needle points at the distal end of the tube, the second bevel angle being shallower than the first bevel angle, the second bevel being located adjacent the proximal end of the first bevel, and the inner cutting edge converging to a narrow heel.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 110-. (canceled)11. A method of inserting a medical device into a subject , the method comprising:positioning an insertion assembly on skin of the subject such that an adhesive layer adheres to the skin, the insertion assembly comprising a housing, a torsion spring in a loaded position, a slidable body having a slot and releasably coupled with a needle and the medical device, and a rotor having a projection received within the slot; anddepressing a button of the insertion assembly,wherein depression of the button releases the torsion spring from the loaded position such that the torsion spring causes rotation of the rotor and projection,wherein rotation of the rotor and projection advances the slidable body within the housing, andwherein advancement of the slidable body causes advancement of the needle and the medical device through an aperture in the adhesive layer and into the subject, followed by expansion of a compression spring that causes retraction of the needle.12. The method of claim 11 , wherein the slidable body is a first slidable body claim 11 , further wherein a first end of the compression spring is in contact with the first slidable body and a second end of the compression spring is in contact with a second slidable body.13. The method of claim 12 , wherein the rotation of the rotor and projection advances the first slidable body and the second slidable body simultaneously.14. The method of claim 12 , wherein movement of the second slidable body away from the skin of the subject retracts the needle from the subject.15. The method of claim 12 , wherein rotation of the rotor and projection advances the first slidable body and the second slidable body towards the skin of the subject.16. The method of claim 12 , wherein the second slidable body comprises a slot claim 12 , wherein the projection is received within the slot ...

TUBULAR SENSOR, CONSTITUENT MEASURING DEVICE, AND TUBULAR SENSOR MANUFACTURING METHOD

A puncture needle sensor manufacturing method includes applying an insulation layer to a metal sheet and applying spaced apart stripe-shaped electrodes on the insulation layer after the insulation layer is applied on the metal sheet. The manufacturing method also includes cutting the metal sheet to produce a plate-shaped body that includes at least two of the electrodes. The plate-shaped body is press-worked to form the plate-shaped body into a tubular body, and a pointed, beveled end portion is formed at the distal end of the tubular body. 1. A puncture needle sensor manufacturing method comprising:applying an insulation layer to a metal sheet;applying a plurality of spaced apart stripe-shaped electrodes on the insulation layer after the insulation layer is applied on the metal sheet;cutting the metal sheet, after applying the plurality of electrodes, to produce a plate-shaped body that includes at least two of the electrodes;press-working the plate-shaped body to form the plate-shaped body into a tubular body possessing an inner circumferential surface and a longitudinal extent, the tubular body possessing a distal end portion and a proximal end portion; andforming a pointed, beveled end portion at the distal end of the tubular body to produce the puncture needle sensor.2. The puncture needle sensor manufacturing method according to claim 1 , wherein the at least two electrodes are positioned on the inner circumferential surface of the tubular body and extending in a direction of the longitudinal extent of the tubular body.3. The puncture needle sensor manufacturing method according to claim 1 , further comprising welding a longitudinally extending seam of the tubular body after the press-working of the plate-shaped body.4. The puncture needle sensor manufacturing method according to claim 1 , wherein the cutting of the metal sheet comprises cutting the metal sheet so that the plate-shaped body remains partially connected claim 1 , during at least some of the ...

Methods and Structures for Assembling Lancet Housing Assemblies for Handheld Medical Diagnostic Devices

A method of assembling a lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is disclosed. The method includes forming a plurality of lancet structures in a lancet sheet. The lancet sheet has a removable ledge for releasing the lancet structures. The removable ledge of the lancet sheet is flexed for releasing the lancet structures from the removable ledge. 1. A lancet sheet providing multiple lancets for a lancet housing assembly for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient , the lancet sheet comprising:a removable ledge formed of material forming the lancet sheet;a plurality of lancet structures formed of material forming the lancet sheet, the plurality of lancet structures comprising a skin penetrating end and a blood transport portion adjacent the skin penetrating end, wherein the skin penetrating end is shaped and sized to penetrate the patient's skin at the skin site to provide an amount of blood; anda plurality of spring components formed of material that forms the lancet sheet that releasably connect the plurality of lancet structures to the removable ledge.2. The lancet sheet of claim 1 , wherein the plurality of spring components comprise:an attachment spring arm connected to a lancet structure of the plurality of lancet structures; anda ledge attachment arm that connects the attachment spring arm to the removable ledge.3. The lancet sheet of claim 2 , wherein the attachment spring arm is connected to the lancet structure by a lancet attachment arm claim 2 , wherein the lancet attachment arm is connected at a first end of the attachment spring arm claim 2 , the attachment spring arm being connected at a second opposite end to the ledge attachment arm.4. The lancet sheet of claim 3 , wherein the lancet attachment arm is connected to the lancet structure by a breakable finger.5. ...

PUSH- OR TWIST- INITIATED BLOOD METERING, FILTERING AND/OR STORAGE

A device uses twist- or push-initiated force to collect, meter, filter and store a blood sample. 1. A blood sample collection device comprising:a housing; the collection well having an opening at a top and a pierceable membrane located adjacent a bottom, the collection well further defined by a lower region having a defined volume for collecting a metered portion of the blood sample, and an upper region for accepting an excess portion of the blood sample in excess of the defined volume, and', 'the cap engaging the upper region of the well, and providing twist- or push-initiated mechanical force on the well, and also piercing the membrane in response to the mechanical force;', 'absorptive media, disposed adjacent and in fluid communication with the upper region of the well, for storing the excess portion of the blood sample in excess of the defined volume;', 'a filter, disposed adjacent the pierceable membrane, for filtering the metered portion of the blood sample to provided a filtered blood sample; and', 'a storage media, disposed within the housing adjacent the filter, for storing the the filtered blood sample., 'a metering component comprising a collection well and a cap,'}2. The device of additionally wherein the storage media is disposed below the pierceable membrane.3. The device of additionally wherein the defined volume is further defined by a ledge formed on the periphery of the well.4. The device of additionally wherein fluid communication between the upper region of the well and the absorptive media is provided by one or more ports formed in the housing adjacent the ledge.5. The device of additionally wherein the cap engages the ledge for providing the twist- or push-initiated mechanical force.6. The device of additionally wherein the storage media is a microfluidic separation media for separating plasma from whole blood in the blood sample.7. The device of additionally comprising one or more supports for supporting the microfluidic separation media ...

METHOD OF MAKING MICRONEEDLES, MOLD ASSEMBLY THEREFOR AND MICRONEEDLES ARRAY

A mold assembly for forming a microneedle array exhibiting different aspect ratios is described. The mold assembly comprises a plurality of laminate mold layers , each of the laminate mold layers having a plurality of laminate recesses and wherein the plurality of laminate recesses cooperate with an adjacent laminate mold layer to define a plurality of laminate cavities, and a base mold portion having a base cavity configured to be disposed adjacent the plurality of laminate cavities such that the base cavity and the laminate cavities cooperate to define a mold for a microneedle array, wherein at least a portion of the plurality of laminate cavities vary in size relative to each other to provide a varying aspect ratio.

INTRA-MOLD STERILIZATION OF PLASTIC-EMBEDDED NEEDLE

Methods for intra-mold sterilization of a plastic-embedded metal component of a product, such as a medical lancet having a metal needle embedded within a plastic lancet body. For example, a lancet needle is retained within a mold, plastic is injected to encapsulate the needle, and a specified minimum temperature is maintained for a specified minimum cycle time. In example forms, the specified minimum mold temperature is at least about 370 degrees Fahrenheit and the specified minimum cycle time is at least about 10 seconds. 1. A method for manufacturing a sterile lancet comprising:retaining a lancet needle within a mold cavity of a mold;injecting plastic to form a lancet body substantially encapsulating the needle therein; andmaintaining a specified minimum mold temperature for a specified minimum cycle time effective to sterilize the lancet needle.2. The method of claim 1 , wherein the lancet further comprises a removable endcap detachably secured to the plastic lancet body and covering a sharp tip of the needle.3. The method of claim 1 , wherein the specified minimum temperature is at least about 370° Fahrenheit.4. The method of claim 1 , wherein the specified minimum time is at least about 10 seconds.5. The method of claim 1 , wherein the specified minimum mold temperature is maintained by a heating element at least partially embedded in the mold and adjacent the mold cavity.6. The method of claim 5 , wherein the heating element is embedded completely within the mold and does not interfere with the mold cavity.7. A lancet comprising a needle having a sharp tip and a plastic lancet body claim 5 , wherein the needle is at least partially embedded in the plastic lancet body claim 5 , and wherein at least the sharp tip of the needle is sterilized during manufacture by molding the plastic lancet body around the needle in a mold and maintaining a specified minimum mold temperature for a specified minimum cycle time effective to sterilize the sharp tip of the needle.8. A ...

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 110-. (canceled)11. An inserter assembly for inserting a glucose sensor into a subject , the inserter assembly comprising:an inserter housing;the glucose sensor disposed within the inserter housing, wherein a part of the glucose sensor is configured to be inserted under a skin surface of the subject;a rotor disposed within the inserter housing, the rotor comprising a rotor follower projection;a torsion spring received within the rotor, wherein the torsion spring is configured to cause rotation of the rotor and the rotor follower projection;a first slidable body disposed within the inserter housing, the first slidable body comprising a slot, wherein the rotor follower projection is received within the slot, and wherein the rotation of the rotor and the rotor follower projection causes the first slidable body, a second slidable body, and the glucose sensor to advance within the inserter housing in a direction towards an insertion site on the skin surface of the subject;the second slidable body disposed within the inserter housing, wherein the second slidable body is coupled with a needle; anda compression spring configured to expand and to retract the second slidable body and the needle in a direction away from the insertion site while the glucose sensor remains at the insertion site.12. The inserter assembly of claim 11 , wherein a first end of the compression spring is in contact with the first slidable body and a second end of the compression spring is in contact with the second slidable body.13. The inserter assembly of claim 11 , wherein the rotation of the rotor and the rotor follower projection causes the first slidable body and the second slidable body to advance simultaneously.14. (canceled)15. The inserter assembly of claim 11 , wherein at least a portion of the glucose sensor is disposed within the needle during advancement ...

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 110-. (canceled)11. A glucose monitoring system , comprising:a glucose sensor disposed within an inserter housing; the inserter housing comprising a recess and a button;', 'a rotor comprising a cylindrical shape, wherein the rotor is disposed within the recess of the inserter housing, and wherein the rotor comprises a rotor follower projection;', 'a torsion spring received within the rotor, wherein the torsion spring is in a loaded state prior to depression of the button, and wherein the torsion spring is configured to cause rotation of the rotor upon depression of the button;', 'a first slidable body disposed within the inserter housing, the first slidable body comprising a slot, wherein the rotor follower projection is received within the slot, wherein the rotation of the rotor causes the first slidable body, a second slidable body, and the glucose sensor to advance within the inserter housing in a direction towards an insertion site on a skin surface of the subject, such that a distal end of the glucose sensor is inserted under the skin surface of the subject at the insertion site;', 'the second slidable body disposed within the inserter housing, wherein the second slidable body is coupled with a needle; and', 'a compression spring configured to expand and to retract the second slidable body and the needle in a direction away from the insertion site while the distal end of the glucose sensor remains under the skin surface of the subject at the insertion site; and, 'an inserter, comprising wherein the rotation of the rotor causes the first slidable body and the second slidable body to advance simultaneously towards the insertion site,', 'and', 'wherein the glucose sensor is configured to operate for a period of about seven days or more., 'a mount configured to be applied by the inserter on the skin surface of the subject before ...

Medical device for analyte monitoring and drug delivery

The invention relates to an ingestible, implantable or wearable medical device comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical parameter data of an interaction between the disease marker biological analyte with the bioactive agent; a biometric recognition device capable of comparing the physical parameter data with an analyte interaction profile; optionally a therapeutic agent releasing device capable of controlling release of the therapeutic agent from the reservoirs; an interface device capable of facilitating communications between the microarray scanning device, biometric recognition device and the therapeutic agent releasing device; and an energy source to power the medical device. Specifically, the invention relates to a medical device capable of detecting an analyte in a bodily fluid comprising at least one microneedle capable of obtaining a sample of a bodily fluid, a first microchannel through which the sample flows and is in fluid communication with the at least one microneedle, a second microchannel in fluid communication with the first microchannel, through which a buffer flows, wherein the second channel comprises a microarray with a bioactive agent, a microarray scanning device to detect an interaction between the bioactive agent and the analyte in the bodily fluid; and an interface device.

Medical device for analyte monitoring and drug delivery

The invention relates to an ingestible, implantable or wearable medical device comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical parameter data of an interaction between the disease marker biological analyte with the bioactive agent; a biometric recognition device capable of comparing the physical parameter data with an analyte interaction profile; optionally a therapeutic agent releasing device capable of controlling release of the therapeutic agent from the reservoirs; an interface device capable of facilitating communications between the microarray scanning device, biometric recognition device and the therapeutic agent releasing device; and an energy source to power the medical device. Specifically, the invention relates to a medical device capable of detecting an analyte in a bodily fluid comprising at least one microneedle capable of obtaining a sample of a bodily fluid, a first microchannel through which the sample flows and is in fluid communication with the at least one microneedle, a second microchannel in fluid communication with the first microchannel, through which a buffer flows, wherein the second channel comprises a microarray with a bioactive agent, a microarray scanning device to detect an interaction between the bioactive agent and the analyte in the bodily fluid; and an interface device.

Rapid delivery and/or receiving of fluids

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus. For example, blood may be received from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. In another aspect, the present invention is generally directed to arrangements of skin insertion objects such as microneedles and methods of forming and arranging skin insertion objects. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

BLOOD COLLECTABLE PERIPHERAL INTRAVENOUS CATHETER ASSEMBLIES AND RELATED METHODS

Peripheral intravenous catheter assemblies with capabilities for both blood sampling and catheterization can have a blood collection holder with a needle hub attached to a catheter hub. The combination catheter assembly and blood sampling holder can be called a catheter and holder assembly. Blood sampling can be done directly through the needle and the blood collection holder after cannulation. After blood sampling, the blood collection holder and the needle can be removed, leaving the catheter hub with the patient for IV infusion. The catheter hub can be a straight catheter hub or can include a side fluid port for use in as an integrated IVC. 117-. (canceled)18. A catheter and holder assembly comprising:a catheter hub having a catheter tube with a distal opening attached to the catheter hub;a needle comprising a sharpened distal needle tip and a sharpened proximal needle tip and wherein the sharpened distal needle tip projects out the distal opening of the catheter tube; anda blood collection holder having needle hub with a bore having the needle passing therethrough and a housing having an interior space dimensioned to receive a vacutainer;wherein the catheter hub is in contact with the blood collection holder and the sharpened proximal needle tip is located within the interior space of the housing in a ready to use position.19. The catheter and holder assembly according to claim 18 , wherein the needle comprises a notch claim 18 , a crimp claim 18 , a sleeve claim 18 , or a buildup located proximally of the sharpened distal needle tip.20. The catheter and holder assembly according to claim 18 , wherein the blood collection holder comprises an end wall and a sidewall defining the interior space and the needle hub is integrated with the end wall.21. The catheter and holder assembly according to claim 18 , wherein the sharpened proximal needle tip is in the interior space of the blood collection holder when the catheter and holder assembly is in the ready to use ...

LANCET DEVICE WITH FLEXIBLE COVER

The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet. 1. A biological test kit comprising: a) a rigid first layer; b) one or more lancets secured to the first layer , said lancets each having a sharp region disposed substantially away from the first layer; c) one or more second layers disposed in an opposed arrangement relative to the first layer , the first and second layers being arranged to form one or more cavities there-between , each of the one or more second layers forming one or more covers , each cover over one of the lancets;and d) each of the one or more covers having a first unconstrained configuration in which the lancet sharp region does not protrude past or through the cover and having a second compressed configuration in which the lancet sharp region protrudes through the cover.2. The biological test kit of wherein said covers are resilient such that the cover can pass from the unconstrained configuration to the compressed configuration when a compression force is applied and return from the compressed configuration to the unconstrained configuration when said compression force is removed.3. The biological test kit of further comprising: a) at least one chemical test strip for capturing biological samples.4. The biological test kit of further comprising a testing apparatus for testing one or more chemical properties of biological samples present on said test strip.5. A biological test kit comprising: a) a rigid first layer claim 3 , b) one or more lancets secured to the first layer claim 3 , said lancets each having a sharp region ...

A meter for use in an improved method of reducing interferences in an electrochemical sensor using two different applied potentials

본 발명은 시료들의 측정에서 간섭 화합물의 영향들을 감소시키는 방법을 이용하는 개선된 계량기에 관한 것이고, 보다 상세하게는 테스트 스트립이 2개 이상의 작업 전극들을 이용하는 시스템에서 간섭 화합물들의 영향을 감소시키는 방법에 관한 것이다. 본 발명에 있어서, 제1 전위(E1)는 제1 작업 전극(12)에 인가되고, 동일한 극성을 가지지만 제1 전위(E1)보다 큰 크기를 가지는 제2 전위는 제2 작업 전극(14)에 인가되는 계량기를 설명하고 있다. 이 계량기는 발생된 전류를 측정하고, 측정된 전류를 교정하여 샘플에서의 간섭 화합물의 존재를 보상하도록 소정 알고리즘을 사용한다. The present invention relates to an improved meter using a method of reducing the effects of interference compounds in the measurement of samples, and more particularly to a method of reducing the effects of interference compounds in a system in which a test strip uses two or more working electrodes. will be. In the present invention, the first potential E1 is applied to the first working electrode 12, and the second potential having the same polarity but larger than the first potential E1 is the second working electrode 14. Describes the meter being applied to. This meter uses a predetermined algorithm to measure the generated current and to calibrate the measured current to compensate for the presence of interfering compounds in the sample. 계량기, 포도당, 시료, 테스트 스트립, 간섭 화합물, 작업 전극, 기준 전극. Meter, glucose, sample, test strip, interference compound, working electrode, reference electrode.

Device and method for piercing skin with micro protrusions

FIELD: medicine; medical engineering. SUBSTANCE: method involves making microincisions in cornea layer with microprojecting element. Microprojecting element has single or several protrusions for producing single or several microincisions in cornea layer. The operation is executed with microprotrusions using microprojecting power element of 0.05 J/cm 2 per 10 ms or less with matter introduced or withdrawn via said microincisions. Device has applicator having contact surface, and microprojecting element having single or several protrusions. The microprojecting element is mountable on the applicator after having been unlocked. The applicator enables one to bring contact surface in engagement with the microprojecting element after having been set in action. The microprojecting element acts upon corneal layer with power equal to or less than 0.05 J/cm 2 per 10 ms or less. EFFECT: enhanced effectiveness of treatment. 39 cl, 7 dwg, 1 tbl ÐÎÑÑÈÉÑÊÀß ÔÅÄÅÐÀÖÈß RU (19) (11) 2 275 871 (13) C2 (51) ÌÏÊ A61B 17/20 (2006.01) ÔÅÄÅÐÀËÜÍÀß ÑËÓÆÁÀ ÏÎ ÈÍÒÅËËÅÊÒÓÀËÜÍÎÉ ÑÎÁÑÒÂÅÍÍÎÑÒÈ, ÏÀÒÅÍÒÀÌ È ÒÎÂÀÐÍÛÌ ÇÍÀÊÀÌ (12) ÎÏÈÑÀÍÈÅ ÈÇÎÁÐÅÒÅÍÈß Ê ÏÀÒÅÍÒÓ (21), (22) Çà âêà: 2003110431/14, 12.10.2001 (24) Äàòà íà÷àëà îòñ÷åòà ñðîêà äåéñòâè ïàòåíòà: 12.10.2001 (43) Äàòà ïóáëèêàöèè çà âêè: 27.08.2004 (56) Ñïèñîê äîêóìåíòîâ, öèòèðîâàííûõ â îò÷åòå î ïîèñêå: WO 98/28037 A1, 02.07.1998. GB 2064329 A, 17.06.1981. SU 209631 À, 14.03.1968. US 4527561 A, 09.07.1985. (85) Äàòà ïåðåâîäà çà âêè PCT íà íàöèîíàëüíóþ ôàçó: 11.04.2003 2 2 7 5 8 7 1 R U (87) Ïóáëèêàöè PCT: WO 02/30301 (18.04.2002) C 2 C 2 (86) Çà âêà PCT: US 01/31936 (12.10.2001) Àäðåñ äë ïåðåïèñêè: 129010, Ìîñêâà, óë. Á.Ñïàññêà , 25, ñòð.3, ÎÎÎ "Þðèäè÷åñêà ôèðìà Ãîðîäèññêèé è Ïàðòíåðû", ïàò.ïîâ. Þ.Ä.Êóçíåöîâó (54) ÓÑÒÐÎÉÑÒÂÎ È ÑÏÎÑÎÁ ÄËß ÏÐÎÊÀËÛÂÀÍÈß ÊÎÆÈ ÌÈÊÐÎÂÛÑÒÓÏÀÌÈ (57) Ðåôåðàò: Ãðóïïà èçîáðåòåíèé îòíîñèòñ ê õèðóðãèè è ìîæåò áûòü èñïîëüçîâàíà, â ÷àñòíîñòè, äë ÷ðåñêîæíîãî ââåäåíè âåùåñòâ. Ñïîñîáû ââåäåíè èëè èçú òè âåùåñòâà ÷åðåç ðîãîâîé ñëîé ...

Устройства и способы для отбора проб и измерения компонента биологической жидкости

2002115719 А ко РОССИЙСКАЯ ФЕДЕРАЦИЯ (19) ФЕДЕРАЛЬНАЯ СЛУЖБА ПО ИНТЕЛЛЕКТУАЛЬНОЙ СОБСТВЕННОСТИ, ПАТЕНТАМ И ТОВАРНЫМ ЗНАКАМ <: м 77 & ВО” 2002 д 7 Х р 7 72 27 > > 2% 2 51) МК’ С 01 М 33/487 (12 ИЗВЕЩЕНИЯ К ЗАЯВКЕ НА ИЗОБРЕТЕНИЕ (21), (22) Заявка: 2002115719/14, 11.06.2002 (30) Конвенционный приоритет: 12.06.2001 Ц$ 09/879,188 (43) Дата публикации заявки: 20.01.2004 Адрес для переписки: 129010, Москва, ул. Б.Спасская, 25, стр.3, ООО "Юридическая фирма Городисский и Партнеры", пат.пов. Г.Б. Егоровой (71) Заявитель(и): ЛАЙФСКЕН, ИНК. (Ц5$) (72) Автор(ы): ШАРТЛ Роберт (0$), ЛЕОНГ Коон-вах (1$), КАЙСЕР Эрнест (ЦЗ) (74) Патентный поверенный: Егорова Галина Борисовна (54) Устройства и способы для отбора проб и измерения компонента биологической жидкости ГАЭА - Признание заявок на изобретение отозванными в связи с непредставлением в установленный срок ходатайства о проведении экспертизы заявки по существу Дата отзыва заявки: 14.07.2006 Извещение опубликовано: 27.08.2006 БИ: 24/2006 Страница: 1 бя о00Сс ПЧ А"

Lancet analyte sensors and methods of manufacturing

本发明在一些方面提供一种用于获得并检测生物流体样本中分析物浓度水平的分析物传感器。该分析物传感器具有包含半导体材料的传感器主体、连接到传感器主体的活性区以及设置在分析物传感器上的刺血针。所述传感器主体可包括纤维，所述纤维具有导电材料构成的芯部和包围芯部的半导体包层。本发明还提供多种其他方面的改进。

Biological fluid constituent sampling and measurement devices and methods

생물학적 유체를 액세싱(access)하고, 생물학적 유체 성분을 샘플링한 다음, 액세싱된 생물학적 유체내 하나 이상의 표적 성분의 농도를 측정하기 위한 장치가 제공된다. 장치는 선택된 깊이로 피부를 천공시키고 생물학적 유체를 액세싱하기 위해 사용되는 하나 이상의 미세 천공 부재, 성분 샘플링 수단 및 성분 측정 수단을 갖는다. 성분 샘플링 수단은 샘플링된 성분을 미세 천공 부재로부터 측정 수단으로 운반하는 성분 운반 매질, 예를 들면, 친수성 겔 물질을 포함한다. 측정 수단은 하나 이상의 샘플링된 성분을 전기 화학적 셀로 도입시키는 하나 이상의 다공성 전극을 갖는 전기 화학적 셀을 포함한다. 피부 내 성분을 샘플링하고 샘플링된 성분을 측정하는 방법뿐만 아니라 본 발명을 수행하기 위한 키트가 제공된다.

Applicator for power influence by microknives set

FIELD: surgery. SUBSTANCE: applicator can be used for through-skin injection of matters. Devices for power influence by penetrating member onto corneous layer have case with first and second ends, piston, power spring, blocking mechanism and unblocking mechanism. First end of case is made for placement of penetrating member. Piston is disposed for slide inside the case for power influence by penetrating member on corneous layer. Power spring intends for generation of influence force onto piston and for displacement of piston behind first end of case. The spring is capable of compressing matter along the passage of piston inside case. Blocking mechanism is made for unblock of engagement of piston and case by one hand after the piston finds its place inside the case. Power spring effects by piston onto penetrating member and presses penetrating member out into mentioned corneous layer. Methods of triggering of the device and of power influencing by penetrating member onto corneous layer have steps of displacement and block of device with piston and case. Displacement of piston to position of triggering relatively case is carried out by pressing piston and case with blocked piston at triggering position by mentioned pressing. Device is made for triggering and blocking by means of one hand only. As a result spring-loaded applicator is proposed for through-skin member which is triggered by one hand of user. EFFECT: improved efficiency; minimal force of hand. 22 cl, 7 dwg ÐÎÑÑÈÉÑÊÀß ÔÅÄÅÐÀÖÈß RU (19) (11) 2 277 390 (13) C2 (51) ÌÏÊ A61B 17/20 (2006.01) ÔÅÄÅÐÀËÜÍÀß ÑËÓÆÁÀ ÏÎ ÈÍÒÅËËÅÊÒÓÀËÜÍÎÉ ÑÎÁÑÒÂÅÍÍÎÑÒÈ, ÏÀÒÅÍÒÀÌ È ÒÎÂÀÐÍÛÌ ÇÍÀÊÀÌ (12) ÎÏÈÑÀÍÈÅ ÈÇÎÁÐÅÒÅÍÈß Ê ÏÀÒÅÍÒÓ (21), (22) Çà âêà: 2003110432/14, 12.10.2001 (30) Êîíâåíöèîííûé ïðèîðèòåò: 13.10.2000 (ïï.1-21) US 60/240,436 (73) Ïàòåíòîîáëàäàòåëü(è): ÀËÇÀ ÊÎÐÏÎÐÅÉØÍ (US) (43) Äàòà ïóáëèêàöèè çà âêè: 27.08.2004 R U (24) Äàòà íà÷àëà îòñ÷åòà ñðîêà äåéñòâè ïàòåíòà: 12.10.2001 (72) Àâòîð(û): ÒÐÎÒÌÝÍ Äæîçåô Ê. (US), ÊÈÍÝÍ ...

Biological fluid constituent sampling and measurement devices

생물학적 유체에 접근하여 당해 생물학적 유체 성분을 샘플링한 다음, 접근한 생물학적 유체내 하나 이상의 표적 성분의 농도를 측정하기 위한 장치가 제공된다. 장치는 소정 깊이로 피부를 천공시키고 생물학적 유체에 접근하기 위해 사용되는 하나 이상의 미세 천공 부재, 성분 샘플링 수단 및 성분 측정 수단을 갖는다. 성분 샘플링 수단은 샘플링된 성분을 미세 천공 부재로부터 측정 수단으로 운반하는 성분 운반 매질, 예를 들면, 친수성 겔 물질을 포함한다. 측정 수단은 하나 이상의 샘플링된 성분을 전기 화학적 전지로 도입시키는 하나 이상의 다공성 전극을 갖는 전기 화학적 전지를 포함한다. 피부 내 성분을 샘플링하고 샘플링된 성분을 측정하는 방법뿐만 아니라 본 발명을 수행하기 위한 키트가 제공된다. 생물학적 유체, 미세 천공 부재, 성분 샘플링 수단, 성분 측정 수단, 전기 화학적 전지.

Medical devices for analyte monitoring and drug delivery

Microblade array impact applicator

어플리케이터 장치(10)는 미세 돌기 어레이를 갖는 패치(44)를 각질층에 부착하기 위하여 제공된다. 어플리케이터 장치(10)는 장치 몸체(12) 및 장치 몸체 내에서 이동 가능한 피스톤을 포함한다. 장치(10)가 각질층을 미세 돌기 어레이(44, 90)로 충격시키기 위하여 캡(16)은 장치 몸체(12) 상에 제공된다. 장치(10)는 사용자의 한 손 작동에 의해 코킹될 수 있으며, 이는 다른 형태의 어플리케이터 장치들을 코킹시키기 위한 힘도 손재주도 갖고 있지 않은 환자들에 의해 장치(10)가 사용되는 것을 가능하게 한다. The applicator device 10 is provided for attaching a patch 44 having a fine protrusion array to the stratum corneum. Applicator device 10 includes a device body 12 and a piston moveable within the device body. A cap 16 is provided on the device body 12 for the device 10 to impinge the stratum corneum onto the microprojection arrays 44, 90. The device 10 can be caulked by one-handed operation of the user, which enables the device 10 to be used by patients who have neither the strength nor dexterity to caulk other types of applicator devices. 마이크로블레이드, 미세돌기 어레이, 각질층, 투과 부재, 충격 장치 Microblade, Microprojection Array, Horny Layer, Permeable Member, Impact Device

DEVICES AND METHODS FOR SLEEPING SAMPLING AND MEASURING THE COMPONENT OF BIOLOGICAL LIQUID

2002115721 А ко РОССИЙСКАЯ ФЕДЕРАЦИЯ (19) ФЕДЕРАЛЬНАЯ СЛУЖБА ПО ИНТЕЛЛЕКТУАЛЬНОЙ СОБСТВЕННОСТИ, ПАТЕНТАМ И ТОВАРНЫМ ЗНАКАМ 77 & (11) | _(13) ВИ 2002115? А < скКх А х \ 7 7 2 51) МК’ 6 04 М 33/48 (12 ИЗВЕЩЕНИЯ К ЗАЯВКЕ НА ИЗОБРЕТЕНИЕ (21), (22) Заявка: 2002115721/14, 11.06.2002 (30) Конвенционный приоритет: 12.06.2001 Ц$ 09/878,742 (43) Дата публикации заявки: 20.01.2004 Адрес для переписки: 129010, Москва, ул. Б.Спасская, 25, стр.3, ООО "Юридическая фирма Городисский и Партнеры", пат.пов. Г.Б. Егоровой (71) Заявитель(и): ЛАЙФСКЕН, ИНК. (Ц5$) (72) Автор(ы): СОХРАБ Борзу (1$) (74) Патентный поверенный: Егорова Галина Борисовна (54) УСТРОЙСТВА И СПОСОБЫ ДЛЯ ПОДКОЖНОГО ОТБОРА ПРОБ И ИЗМЕРЕНИЯ КОМПОНЕНТА БИОЛОГИЧЕСКОЙ ЖИДКОСТИ ГАЭА - Признание заявок на изобретение отозванными в связи с непредставлением в установленный срок ходатайства о проведении экспертизы заявки по существу Дата отзыва заявки: 14.07.2006 Извещение опубликовано: 27.08.2006 БИ: 24/2006 Страница: 1 ся о00с пы“ А"

Methods and apparatus for lancet actuation

A lancet driver is provided wherein the driver exerts a driving force on a lancet during a lancing cycle and is used on a tissue site. The driver comprises of a drive force generator for advancing the lancet along a path into the tissue site, and a manual switch for a user interface input.

Low pain penetrating

Reducing the volume or drag on skin of the penetrating member (183) entering the wound during the cutting process will reduce the pain associated with lancing and result in less power desired for retraction of the penetrating member from the skin (233). A variety of other penetrating member configuration is shown in the application.

Tissue penetration device

A body fluid testing device has at least one penetrating member and a penetrating member driver configured to be coupled to the at least one penetrating member. A plurality of analyte sensors are coupled to a spoked disk substrate. Each of a penetrating member can pass between spokes of the disk substrate to provide that a used penetrating member can be removed and a new penetrating inserted without removing the disk. A disposable houses the at least one penetrating member and the plurality of analyte sensors.

A microbiopsy device

A microbiopsy device for taking biological samples, comprising a body including two or more cutting elements for cutting tissue to form a biological sample; and a chamber inside the body for receiving and retaining the biological sample, the chamber having an opening between the cutting elements, wherein the cutting elements are arranged to cut a section of tissue having a width of less than 1 mm.

Two-dimensional needle array device and method of use

In one aspect, the present disclosure relates to a device for obtaining biological tissue. In some embodiments, the device can include a first row of a plurality of hollow tubes; a second row of a plurality of hollow tubes, adjacent the first row of hollow tubes; a third row of a plurality of hollow tubes, adjacent the second row of hollow tubes, the first, second and third rows forming an array of hollow tubes; wherein each hollow tube can include at least one point at the distal end of the hollow tube, the plurality of rows forming a two dimensional array of hollow tubes; wherein an inner diameter of the at least one tube is less than about 1 mm, the distal end of each of the hollow tubes is configured to be inserted into a biological tissue donor site to remove a portion of tissue therefrom when each of the hollow tubes is withdrawn from the donor site.

Systems and methods of sample processing and fluid control in a fluidic system

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

Method for producing an analytical magazine

분석 수집부 (110) 를 제조하는 방법이 제공된다. 상기 부석 수집부 (110) 는 다수의 챔버 (122) 내에 다수의 분석 보조 장치 (134) 를 수용하도록 구성된다. 상기 제조 방법은 - 상기 분석 수집부의 다수의 수용부 (120) 가 형성된 적어도 하나의 (110) 제 1 요소 (112) 를 제공하는 단계, - 서로 연결되고, 적어도 하나의 유지 부재 (144) 를 통해 바람직하게는 배열된 다수의 분석 보조 장치 (134) 를 제공하는 단계, - 상기 수용부 (120) 에 상기 분석 보조 장치 (134) 를 인도하여, 상기 챔버 (122) 다수 또는 바람직하게는 모두가 동시에 장착되는 단계, - 상기 유지 부재 (144) 로부터 상기 분석 보조 장치 (134) 를 분리하는 단계를 포함한다. A method of manufacturing the assay collection unit 110 is provided. The pumice collector 110 is configured to receive a plurality of analysis aids 134 in the plurality of chambers 122. The above- Providing at least one (110) first element (112) in which a plurality of receptacles (120) of said analytical collection part are formed, Providing a plurality of analytical aids 134 connected to each other and preferably arranged through at least one retaining member 144, Directing the analytical aids 134 to the receptacle 120 such that a plurality or preferably all of the chambers 122 are simultaneously mounted, Separating the assay aid 134 from the retaining member 144.

Microneedle devices and methods of manufacture

Microneedle devices and methods of manufacturing the microneedle devices. The microneedle devices include microneedles protruding from a substrate, with the microneedles piercing a cover placed over the substrate surface from which the microneedles protrude. The cover and the microneedle substrate together define a capillary volume in fluid communication with the base of each microneedle. One manner of using microneedle arrays of the present invention is in methods involving the penetration of skin to deliver medicaments or other substances and/or extract blood or tissue. Manufacturing methods may include simultaneous application of pressure and ultrasonic energy when piercing the cover with the microneedles.

Microneedle arrays and methods of manufacturing the same

Microneedle arrays, methods of manufacturing microneedles and methods of using microneedle arrays. The microneedles in the microneedle arrays may be in the form of tapered structures that include at least one channel formed in the outside surface of each microneedle. The microneedles may have bases that are elongated in one direction. The channels in microneedles with elongated bases may extend from one of the ends of the elongated bases towards the tips of the microneedles. The channels formed along the sides of the microneedles may optionally be terminated short of the tips of the microneedles. The microneedle arrays may also include conduit structures formed on the surface of the substrate on which the microneedle array is located. The channels in the microneedles may be in fluid communication with the conduit structures. One manner of using microneedle arrays of the present invention is in methods involving the penetration of skin to deliver medicaments or other substances and/or extract blood or tissue.

Apparatus and method for piercing skin with microprotrusions

A method and device are described for applying a microprotrusion member (44) including a plurality of microprotrusions (90) to the stratum corneum with impact. The method and device are used to improve transport of an agent acro ss the skin for agent delivery or sampling. The applicator (10, 60, 80) causes the microprotrusion member (44) to impact the stratum corneum with a certain amount of impact determined to effectively pierce the skin with the microprotrusions (90). The preferred applicator (10, 60, 80) impacts the stratum corneum with the microprotrusion member (44) with an impact of at least 0.05 joules per cm2 of the microprotrusion member (44) in 10 msec or less.

Microneedles and methods for fabricating microneedles

A plastic microneedle comprising: a body portion tapering from a larger end of the body portion towards a tip portion of the body portion; at least one side port; and a lumen extending from the larger end of the body portion and within the body portion of the microneedle, wherein the side port extends into the lumen such that the side port and the lumen are in fluid communication with each other.

Microneedle device for transport of molecules across tissue

Microneedle devices for transport of therapeutic and diagnostic materials and/or energy across tissue barriers, and methods for manufacturing the devices, are provided. The microneedles are hollow and/or porous and have diameters between about 10 nm and 1 mm. The microneedle devices permit drug delivery (or removal or sensing of body fluids) at clinically relevant rates across skin or other tissue barriers, without damage, pain, or irritation to the tissue. Microfabrication techniques are used to cost-effectively produce arrays of microneedles from metals, silicon, silicon dioxide, ceramic, and polymeric materials. Methods are provided for making porous or hollow microneedles.

Medical device for analyte monitoring and drug delivery

본 발명은 질병 마커 생물 피분석물과 상호작용할 수 있는 생활성제를 포함하는 마이크로어레이; 1종 이상의 치료제를 포함하고 의료 기기로부터 상기 치료제(들)를 방출할 수 있는 저장소; 질병 마커 생물 피분석물과 생활성제 사이의 상호작용의 물리적 파라미터 데이타를 수득할 수 있는 마이크로어레이 스캐닝 장치, 상기 물리적 파라미터 데이타와 피분석물 상호작용 프로파일을 비교할 수 있는 생체 인식 장치, 임의로 저장소로부터의 치료제의 방출을 제어할 수 있는 치료제 방출 장치, 상기 마이크로어레이 스캐닝 장치, 상기 생체 인식 장치 및 상기 치료제 방출 장치 사이의 정보전달을 촉진할 수 있는 인터페이스 장치를 포함하는 복수개의 마이크로칩; 및 의료 기기에 동력을 공급하는 에너지원을 포함하는 것인, 섭취가능하거나, 이식가능하거나 또는 착용가능한 의료 기기에 관한 것이다. 구체적으로, 본 발명은 채액 샘플을 수득할 수 있는 하나 이상의 미세바늘, 샘플이 흐르는 채널이며 하나 이상의 미세바늘과 유체 통신 상태에 있는 제1의 마이크로채널, 제1의 마이크로채널과 유체 통신 상태에 있고, 완충제가 흐르는 채널이며, 1종 이상의 생활성제를 갖는 마이크로어레이를 추가로 포함하는 제2의 마이크로채널, 생활성제와 채액 중의 피분석물 사이의 상호작용을 검출하는 마이크로어레이 스캐닝 장치, 및 인터페이스 장치를 포함하는, 체액 중의 피분석물을 검출할 수 있는 의료 기기에 관한 것이다. The present invention provides a microarray comprising a bioactive agent capable of interacting with a disease marker biomarker; A reservoir containing one or more therapeutic agents and capable of releasing the therapeutic agent (s) from the medical device; A disease marker, a microarray scanning device capable of obtaining physical parameter data of the interaction between the biological analyte and the bioactive agent, a biometric device capable of comparing the physical parameter data with the analyte interaction profile, A plurality of microchips including a therapeutic agent releasing device capable of controlling the release of the therapeutic agent, the microarray scanning device, an interface device capable of promoting information transfer between the biometric device and the therapeutic agent releasing device; And an energy source that powers the medical device. &Lt; RTI ID = 0.0 &gt; [0002] &lt; / RTI &gt; Specifically, the present invention relates to a microchannel comprising: at least one microneedle capable of obtaining a sample of beads; a channel through which the sample flows; a first microchannel in fluid communication with the at least one microneedle; A second microchannel further comprising a microarray having one or more ...

Medical lancet instrument

Medical device for analyte monitoring and drug delivery

본 발명은 질병 마커 생물 피분석물과 상호작용할 수 있는 생활성제를 포함하는 마이크로어레이; 1종 이상의 치료제를 포함하고 의료 기기로부터 상기 치료제(들)를 방출할 수 있는 저장소; 질병 마커 생물 피분석물과 생활성제 사이의 상호작용의 물리적 파라미터 데이타를 수득할 수 있는 마이크로어레이 스캐닝 장치, 상기 물리적 파라미터 데이타와 피분석물 상호작용 프로파일을 비교할 수 있는 생체 인식 장치, 임의로 저장소로부터의 치료제의 방출을 제어할 수 있는 치료제 방출 장치, 상기 마이크로어레이 스캐닝 장치, 상기 생체 인식 장치 및 상기 치료제 방출 장치 사이의 정보전달을 촉진할 수 있는 인터페이스 장치를 포함하는 복수개의 마이크로칩; 및 의료 기기에 동력을 공급하는 에너지원을 포함하는 것인, 섭취가능하거나, 이식가능하거나 또는 착용가능한 의료 기기에 관한 것이다. 구체적으로, 본 발명은 채액 샘플을 수득할 수 있는 하나 이상의 미세바늘, 샘플이 흐르는 채널이며 하나 이상의 미세바늘과 유체 통신 상태에 있는 제1의 마이크로채널, 제1의 마이크로채널과 유체 통신 상태에 있고, 완충제가 흐르는 채널이며, 1종 이상의 생활성제를 갖는 마이크로어레이를 추가로 포함하는 제2의 마이크로채널, 생활성제와 채액 중의 피분석물 사이의 상호작용을 검출하는 마이크로어레이 스캐닝 장치, 및 인터페이스 장치를 포함하는, 체액 중의 피분석물을 검출할 수 있는 의료 기기에 관한 것이다. The present invention provides a microarray comprising a bioactive agent capable of interacting with a disease marker biomarker; A reservoir containing one or more therapeutic agents and capable of releasing the therapeutic agent (s) from the medical device; A disease marker, a microarray scanning device capable of obtaining physical parameter data of the interaction between the biological analyte and the bioactive agent, a biometric device capable of comparing the physical parameter data with the analyte interaction profile, A plurality of microchips including a therapeutic agent releasing device capable of controlling the release of the therapeutic agent, the microarray scanning device, an interface device capable of promoting information transfer between the biometric device and the therapeutic agent releasing device; And an energy source that powers the medical device. &Lt; RTI ID = 0.0 &gt; [0002] &lt; / RTI &gt; Specifically, the present invention relates to a microchannel comprising: at least one microneedle capable of obtaining a sample of beads; a channel through which the sample flows; a first microchannel in fluid communication with the at least one microneedle; A second microchannel further comprising a microarray having one or more ...

Lancet assembly

A lancet assembly includes an injection molded housing with a metal stylet mounted therein and a cap or shield. The stylet is held in position by adhesive and a plurality of supports that retain a centrally located hub within a lower portion of the housing. An improved cap is provided for mounting over the stylet on the lower portion of the housing to shield the stylet prior to use. The cap also includes an octagonal flange at its lower end to ease removal of the cap from the housing and to provide a flat octagonal surface for independent standing during reshielding. The housing of the lancet assembly includes a plurality of molded-in longitudinal splines that provide a textured surface on the exterior of the housing to make the housing easier to handle and manipulate when loading the lancet assembly into a blood sampling instrument and includes an annular flange extending from the exterior surface of the housing to make insertion/removal of shielded lancet assembly into/from a blood sampling instrument easier.

Microneedle devices and methods of manufacture and use thereof

Microneedle devices are provided for transport of therapeutic and biological molecules across tissue barriers and for use as microflameholders. In a preferred embodiment for transport across tissue, the microneedles are formed of a biodegradable polymer. Methods of making these devices, which can include hollow and/or porous microneedles, are also provided. A preferred method for making a microneedle includes forming a micromold having sidewalls which define the outer surface of the microneedle, electroplating the sidewalls to form the hollow microneedle, and then removing the micromold from the microneedle. In a preferred method of use, the microneedle device is used to deliver fluid material into or across a biological barrier from one or more chambers in fluid connection with at least one of the microneedles. The device preferably further includes a means for controlling the flow of material through the microneedles. Representative examples of these means include the use of permeable membranes, fracturable impermeable membranes, valves, and pumps.

Device for enhancing transdermal release or sampling of drugs

Microprotrusion array and methods of making a microprotrusion

A microprotrusion array is formed from a silicon wafer by a plurality of sequential plasma and wet isotropic and anisotropic etching steps. The resulting microprotrusions (14) have sharpened tips (18) or cutting edges formed by wet isotropic etching, wherein each microprotrusion has a substantially pyramid shape with each side (16) having a concave surface. The tip of each microprotrusion has a substantially flat top surface (20) extending parallel to base (12).

Microneedles for minimally invasive drug delivery

The present invention provides a microneedle incorporating a base that is broad relative to a height of the microneedle, to minimize breakage. The microneedle further includes a fluid channel and a beveled non-coring tip. Preferably arrays of such microneedles are fabricated utilizing conventional semiconductor derived micro-scale fabrication techniques. A dot pattern mask is formed on an upper surface of a silicon substrate, with each orifice of the dot pattern mask corresponding to a desired location of a microneedle. Orifices are formed that pass completely through the substrate by etching. A nitride pattern mask is formed to mask all areas in which a nitride layer is not desired. A nitride layer is then deposited on the bottom of the silicon substrate, on the walls of the orifice, and on the top of the silicon substrate around the periphery of the orifice. The nitride layer around the periphery of the orifice is offset somewhat, such that one side of the orifice has a larger nitride layer. Anisotropic etching is used to remove a substantial portion of the substrate, creating a plurality of angular, blunt, and generally pyramidal-shaped microneedles. A subsequent removal of the nitride layer, followed by an isotropic etching step, softens and rounds out the blunt angular microneedles, providing generally conical-shaped microneedles. The uneven nitride layer adjacent the orifice ensures that the microneedles will include a beveled tip. Such microneedle arrays are preferably incorporated into handheld diagnostic and drug delivery systems.