СИСТЕМА ДЛЯ ОБНАРУЖЕНИЯ АНАЛИТА В ЖИДКОСТИ ТЕЛА

FIELD: medicine. SUBSTANCE: group of inventions relates to medical diagnostics. System for identifying at least one analyte in body fluid such as blood and/or interstitial fluid, in particular for determination of glucose level in blood, is made with possibility of generation of body fluid sample and at least partial transfer of said sample into at least one test element into the area of testing by means of lancet, made in form of at least partially open capillary. Sample volume constitutes less than 1 mcl. System is made in such a way that period of time between sample generation and application on test element constitutes less than 1 s, preferably less than 500 ms. Versions of system, differing in constructive implementation, are disclosed. EFFECT: increased accuracy due to elimination of influence on results of change of sample amount. 17 cl, 6 dwg РОССИЙСКАЯ ФЕДЕРАЦИЯ (19) RU (11) 2 496 406 (13) C2 (51) МПК A61B 5/00 (2006.01) ФЕДЕРАЛЬНАЯ СЛУЖБА ПО ИНТЕЛЛЕКТУАЛЬНОЙ СОБСТВЕННОСТИ (12) ОПИСАНИЕ ИЗОБРЕТЕНИЯ К ПАТЕНТУ (21)(22) Заявка: 2010136021/14, 21.01.2009 (24) Дата начала отсчета срока действия патента: 21.01.2009 (73) Патентообладатель(и): Ф.ХОФФМАНН-ЛЯ РОШ АГ (CH) (43) Дата публикации заявки: 10.03.2012 Бюл. № 7 2 4 9 6 4 0 6 (45) Опубликовано: 27.10.2013 Бюл. № 30 2 4 9 6 4 0 6 R U (85) Дата начала рассмотрения заявки PCT на национальной фазе: 30.08.2010 C 2 C 2 (56) Список документов, цитированных в отчете о поиске: СА 02657265 А, 24.01.2008. US 5100620 А, 31.03.1992. ЕР 0988828 А, 29.03.2000. WO 01/72220 А, 04.10.2001. WO 2007/111651 А, 04.10.2007. RU 2237426 С2, 10.10.2004. RU 2004117068 А1, 20.11.2005. RU 2194446 С2, 20.12.2002. RU 2238147 С2, 20.10.2004. (86) Заявка PCT: EP 2009/050640 (21.01.2009) (87) Публикация заявки РСТ: WO 2009/095343 (06.08.2009) Адрес для переписки: 129090, Москва, ул.Б.Спасская, 25, стр.3, ООО "Юридическая фирма Городисский и Партнеры", пат.пов. А.В.Мицу, рег.№ 364 (54) СИСТЕМА ДЛЯ ОБНАРУЖЕНИЯ АНАЛИТА В ЖИДКОСТИ ТЕЛА (57) ...

Analysegerät mit minimalem Handhabungsaufwand

Verfahren und Vorrichtung zum Ausdrücken von Körperflüssigkeiten aus einem Einstich

Vorrichtung zum Ausdrücken von Körperflüssigkeiten aus einer angestochenen Hautfläche beinhaltend ein Gehäuse und ein Haut-Einstechmedium sowie einen Haut-Stechmechanismus zum Anwenden des Haut-Einstechmediums, um in einer Haut einen Einstich zu bilden und das Haut-Einstechmedium aus dem Einstich der Haut wieder zu entfernen sowie ein an einem Ende des Gehäuses angebrachtes Stimulatorelement wobei das Stimulatorelement dafür ausgelegt ist, um an einem angestochenen Abschnitt einer Hautoberfläche eines Benutzers herum an diesem anzugreifen, so dass das Strömen von Körperflüssigkeit gefördert wird, dadurch gekennzeichnet, dass das Stimulatorelement eine Schraubenfeder aufweist und die Schraubenfeder zum Gehäuse hin zusammendrückbar ist, wenn die Haut eines Benutzers gegen das Stimulationselement gedrückt wird.

Methods and apparatus for expressing body fluid from an incision

A method for hardening at a surface a component

Lancet

BODY FLUID WITHDRAWAL DEVICE

DEVICE TO THE BODY FLUID WITHDRAWAL AND - ANALYSIS

LANZETTE WITH CAPILLARY CHANNEL

MULTILANZETTEN

ANALYZER AT MINIMUM HANDLING EXPENDITURE

LANZETTENSYSTEM

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

DEVICE FOR IMPROVEMENT THE TRANSDERMALEN DECREASE OF BODY FLUIDS

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

Devices, systems, and methods for sample collection

Disclosed herein are devices, apparatus, systems, methods and kits for collecting and storing a fluid sample from a subject. A device for collecting the fluid sample can include a housing comprising a recess having an opening, a vacuum chamber in the housing and in fluidic communication with the recess, and one or more piercing elements that are extendable through the opening to penetrate skin of the subject. The vacuum chamber can be configured for having a vacuum that draws the skin into the recess. The recess can be configured having a size or shape that enables an increased volume of the fluid sample to be accumulated in the skin drawn into the recess.

Means for sampling animal blood

A device (1410) for collecting a blood sample from an animal on sampling media placed (1456) next to the animal's flesh, the device comprising holding means () for holding the sampling media (1456) for placement on the flesh of an animal; spike means (1418) operable to first pass through the sampling media (1456) and to then penetrate into the flesh of the animal to create a puncture site to allow blood emerging from the site to be collected by the sampling media (1456) during and/or after penetration of the flesh, and retaining means (1427) for temporarily retaining the device (1410) on the animal whilst blood is collected on the sampling media and for allowing the device (1410) to be removed from the animal substantially intact for subsequent removal of the sampling media (1456) with the blood from the device.

Body fluid sampling device and methods of use

SYSTEM FOR DETECTION OF AN ANALYTE IN A BODY FLUID

A system (110) is proposed for detection of at least one analyte in a body fluid, in particular for detection of blood glucose. The system (110) is designed in order to generate a sample (130) of the body fluid and to transfer at least part of it to at least one test element (128), in particular a test panel (129). The system (110) is designed such that a time period between the generation of the sample (130) and the application to the test element (128) is less than 1 s, preferably less than 500 ms.

Lancet Blade Designed for Reduced Pain

Lancet drive system using eccentricity of depth control

DISPOSABLE BLOOD-LETTING LANCET

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.

Lancet device

A lancet device is provided capable of taking a sufficient amount of body fluid with less pain or readily healing wounds formed in the skin. The lancet device comprises a plurality of needles for the skin, such as that of a finger tip of a diabetic patient. In the lancet device, the needles are arranged at intervals of a predetermined distance or more, which prevents the wounds formed by needle punctures in the skin from connecting to each other.

УПАКОВКА ДЛЯ МЕДИЦИНСКОГО УСТРОЙСТВА, КОМПЛЕКТ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ

Группа изобретений относится к медицине. Упаковка содержит основной закупоривающий элемент и вспомогательный закупоривающий элемент. Основной закупоривающий элемент имеет выполненную в нем выемку. Основной закупоривающий элемент включает проксимальный конец и дистальный конец. Выемка имеет проем выемки на проксимальном конце основного закупоривающего элемента и конфигурирована для приема и прочного удерживания в ней по меньшей мере частично медицинского устройства с возможностью его извлечения. Вспомогательный закупоривающий элемент выполнен для закупоривания проема выемки, когда медицинское устройство вставлено в выемку. Выемка имеет по меньшей мере один боковой канал, который разделен на участок, используемый перед применением, и участок, используемый после применения. Участок, используемый перед применением, конфигурирован для приема и прочного удерживания с возможностью извлечения медицинского устройства в выемке, а участок, используемый после применения, конфигурирован для приведения ...

Vorrichtung und Verfahren zum Einschneiden

Eine Mehr-Schaft-Vorrichtung zum Einschneiden eines Substrats eines weichen, elastischen Materials, wie z. B. einem Körpergewebe. Die Einschneidevorrichtung weist zwei oder mehr Einschneideschäfte auf, die jeweils eine distale Kante aufweisen. Die Schäfte sind nicht aneinander befestigt, und es ist möglich, daß dieselben gegeneinander gleiten, um die distalen Kanten abwechselnd gegen das Substrat zu treiben, um das Substrat einzuschneiden. In dem Fall des Einschneidens eines Körpergewebes würde eine solche abwechselnde Bewegung weniger Schmerz für den Patienten ergeben als ein Einstich, der sich von einem scharfen Stoß durch einen scharfen Schaft einer ähnlichen Größe wie die Schäfte ergibt.

HILFSVORRICHTUNG ZUM ERZEUGEN VON LÖCHERN.

LANZETTENEINRICHTUNG

HAND ATTACHMENT FOR PRODUCING A PARTING WOUND

DIAGNOSTIC TEST ELEMENT AND PROCEDURE FOR ITS PRODUCTION

MEDICAL NEEDLE AND MEDICINE PRODUCT

Lancet blade designed for reduced pain

Disposable element for use in a body fluid sampling device

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.

MEANS FOR SAMPLING ANIMAL BLOOD

A device (1410) for collecting a blood sample from an animal on sampling media placed (1456) next to the animal's flesh, the device comprising holdin g means () for holding the sampling media (1456) for placement on the flesh of an animal; spike means (1418) operable to first pass through the sampling media (1456) and to then penetrate into the flesh of the animal to create a puncture site to allow blood emerging from the site to be collected by the sampling media (1456) during and/or after penetration of the flesh, and reta ining means (1427) for temporarily retaining the device (1410) on the animal whilst blood is collected on the sampling media and for allowing the device (1410) to be removed from the animal substantially intact for subsequent re moval of the sampling media (1456) with the blood from the device.

RAPID BLOOD EXPRESSION AND SAMPLING

Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, the device further comprising a fluid receiving means remotely spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.

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.

MULTI-LANCET DEVICE

The invention relates to a device for collecting samples of body fluids, comprising at least one lancet, which has a lancet body with at least two ti ps of different length. The device is characterized in that it has a selecti on means, with the aid of which only one tip is selected prior to the punctu re procedure. This selection means can have different functions and shapes. The selection means is used to select one tip from a plurality of lancet tip s of different lengths and to make only this tip available for use in the pu ncturing procedure. Since the various tips are mounted on a lancet body, it is possible to employ a buckling element, for example, to make only one lanc et tip available for use, which buckling element buckles one of the various tips out from the plane of the lancet body. This is especially preferable in lancet tips that are arranged linearly in relation to one another.

LANCET DEVICE

A lancet device includes a body (242) within which is slidably located a trigger (224) and fixedly located a base. The base (214) contains, in an armed position, the lance (202) with its needle (204) and a spring affixed to the lance. The trigger includes means to release the lance during use. In preferred embodiment, the lancet device of the present invention is self-activated by the finger (or other body part) to be pierced. Depression of the trigger with the finger releases the lance and the spring so that the needle protrudes through an orifice in the end of trigger and pierces the tissues. Because the spring is held in a pre-armed position, release of the spring is consistent, and reproducibility of incision is well controlled.

AID TO MAKING HOLES

... 2068535 9108712 PCTABS00005 An aid to making holes (1) for the purpose of puncturing of parts of the body, comprising a hole-maker (2) capable of being guided by a guide component (3). A hole-maker (2) is connected to an articulated link (6, 7) with a to-and-fro pliable effect attached to the guide component (3). The simple function and manufacture of the aid (1) in question are achieved thanks to the present invention.

Insertion needle and lancet with the same

An insertion needle (11) having a first blade surface (12A), a second blade surface (12B), and a third blade surface (12C). In the first blade surface (12A), a portion farthest from the needle tip is formed within a range of 1.5 - 2.5 mm as the distance (D1) in the axial direction (L1) from the needle tip. In the second and third blade surfaces (12B, 12C), portions farthest from the needle tip are formed within a rage of 0.4 - 0.68 mm as the distance (L2) in the axial direction (L1) from the needle tip. Preferably, the ratio (D2/D1) of the distance (D2) to the distance (D1) is set within a range of 0.22 - 0.38.

DEVICES, SYSTEMS, AND METHODS FOR SAMPLE COLLECTION

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.

Five-Bevel Cannula for Blood Acquisition Devices

A needle including a cannula having a multi-beveled point is disclosed. The multi-beveled point includes a primary bevel, two middle bevels, and two tip bevels. Each of the middle bevels extends between the primary bevel and one of the tip bevels. The primary bevel is provided on the cannula at a first angle of inclination and a first angle of rotation, the two middle bevels are provided on the cannula at a second angle of inclination and a second angle of rotation, and the two tip bevels are provided on the cannula at a third angle of inclination and a third angle of rotation. The third angle of inclination is greater than the second angle of inclination, the second angle of inclination is greater than the first angle of inclination, and the second angle of rotation is equal to the third angle of rotation.

Method and apparatus for penetrating tissue

A body fluid sampling system for use on a tissue site includes a single drive force generator. A plurality of penetrating members are operatively coupled to the force generator. The force generator moves each of the members along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A flexible support member couples the penetrating members to define a linear array. The support member is movable and configured to move each of the penetrating members to a launch position associated with the force generator.

Method and apparatus for a multi-use body fluid sampling device with sterility barrier release

A device for use with a gripper is provided. A cartridge is provided that defines a plurality of cavities. A plurality of penetrating members are at least partially contained in the cavities of the cartridge. The penetrating members are slidably movable to extend outward from the cartridge to penetrate tissue. Each cavity has a longitudinal opening that provides access to an elongate portion of the penetrating member. A sterility barrier is coupled to the cartridge. The sterility barrier covers a plurality of the longitudinal openings. The sterility barrier is configured to be moved so that the elongate portion is accessed by the gripper without touching the barrier.

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 ...

LIQUID SAMPLE MEASUREMENT DEVICE

This liquid sample measurement device is provided with: a lancet mounting part to and from which a lancet device having a skin contact section for puncturing skin can be attached and detached; a sensor mounting part to which a biosensor, which is spotted with blood that comes out from the punctured skin, can be attached; and a measurement part that uses the biosensor attached to the sensor mounting part to measure the amounts of substances in the blood. The liquid sample measurement device includes a feature that makes it necessary to replace a lancet device that has been attached to the lance mounting part and has punctured skin, each time a lancet device is used to puncture skin.

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.

СИСТЕМЫ ВЗЯТИЯ ФИЗИОЛОГИЧЕСКОЙ ЖИДКОСТИ И КОНТРОЛЯ, СОДЕРЖАЩЕГОСЯ В НЕЙ АНАЛИТА

ÐÎÑÑÈÉÑÊÀß ÔÅÄÅÐÀÖÈß (19) RU (51) ÌÏÊ 7 (11) 2005 104 830 (13) A A 61 B 5/15 ÔÅÄÅÐÀËÜÍÀß ÑËÓÆÁÀ ÏÎ ÈÍÒÅËËÅÊÒÓÀËÜÍÎÉ ÑÎÁÑÒÂÅÍÍÎÑÒÈ, ÏÀÒÅÍÒÀÌ È ÒÎÂÀÐÍÛÌ ÇÍÀÊÀÌ (12) ÇÀßÂÊÀ ÍÀ ÈÇÎÁÐÅÒÅÍÈÅ (21), (22) Çà âêà: 2005104830/14, 07.06.2004 (71) Çà âèòåëü(è): ËÀÉÔÑÊÅÍ, ÈÍÊ. (US) (30) Ïðèîðèòåò: 06.06.2003 US 60/476,733 28.08.2003 US 10/653,023 04.06.2004 US 10/861,749 (85) Äàòà ïåðåâîäà çà âêè PCT íà íàöèîíàëüíóþ ôàçó: 21.02.2005 (74) Ïàòåíòíûé ïîâåðåííûé: Åãîðîâà Ãàëèíà Áîðèñîâíà (87) Ïóáëèêàöè PCT: WO 2004/107977 (16.12.2004) A R U Ôîðìóëà èçîáðåòåíè 1. Ñèñòåìà âç òè ïðîáû èíòåðñòèöèàëüíîé æèäêîñòè (ISF) è êîíòðîë , ñîäåðæàùåãîñ â íåé àíàëèòà, ïðè ýòîì ñèñòåìà ñîäåðæèò êîíòåéíåð, ñîäåðæàùèé ìîäóëü âç òè ïðîáû äë âç òè ïðîáû ISF èç íàìå÷åííîãî ìåñòà òåëà; è ìîäóëü àíàëèçà äë èçìåðåíè àíàëèòà â ïðîáå ISF; è ìîäóëü ëîêàëüíîãî êîíòðîëëåðà, ýëåêòðè÷åñêè ñâ çàííûé ñ êîíòåéíåðîì, ïðè ýòîì, ëîêàëüíûé êîíòðîëëåð âûïîëíåí ñ âîçìîæíîñòüþ ïîëó÷åíè äàííûõ èçìåðåíèé èç ìîäóë àíàëèçà è õðàíåíè óêàçàííûõ äàííûõ, â êîòîðîé ìîäóëü âç òè ïðîáû ñîäåðæèò ïî ìåíüøåé ìåðå îäíî íàæèìíîå êîëüöî, âûïîëíåííîå ñ âîçìîæíîñòüþ ïðèëîæåíè äàâëåíè ê òåëó âáëèçè íàìå÷åííîãî ìåñòà, è â êîòîðîé ìîäóëü âç òè ïðîáû âûïîëíåí òàê, ÷òî íàæèìíîå êîëüöî ìîæåò ïðèëàãàòü äàâëåíèå ñ îñöèëëèðîâàíèåì, òåì ñàìûì ñîêðàùà ñäâèã ïî ãëþêîçå ISF â ïðîáå ISF, îòáèðàåìîé ìîäóëåì âç òè ïðîáû. 2. Ñèñòåìà ïî ï.1, â êîòîðîé íàæèìíîå êîëüöî âûïîëíåíî ñ âîçìîæíîñòüþ ïðèëîæåíè äàâëåíè â òå÷åíèå ïðèáëèçèòåëüíî 85 ñ èç ïðèáëèçèòåëüíî 15-ìèíóòíîãî öèêëà âç òè ïðîáû. 3. Ñèñòåìà ïî ï.1, â êîòîðîé ìîäóëü âç òè ïðîáû äîïîëíèòåëüíî ñîäåðæèò ýëåìåíò ðåãóëèðîâàíè ãëóáèíû âíåäðåíè . 4. Ñèñòåìà ïî ï.3, â êîòîðîé ýëåìåíò ðåãóëèðîâàíè ãëóáèíû âíåäðåíè îáúåäèíåí ñ ïî ìåíüøåé ìåðå îäíèì íàæèìíûì êîëüöîì ìîäóë âç òè ïðîáû. 5. Ñèñòåìà ïî ï.1, â êîòîðîé ìîäóëü âç òè ïðîáû ñîäåðæèò ïðîíèêàþùèé ýëåìåíò, ïðè ýòîì ïðîíèêàþùèé ýëåìåíò ìîæíî ïåðåìåùàòü íåçàâèñèìî îò ïî ìåíüøåé ìåðå îäíîãî Ñòðàíèöà: 1 RU A (54) ÑÈÑÒÅÌÛ ÂÇßÒÈß ÔÈÇÈÎËÎÃÈ×ÅÑÊÎÉ ÆÈÄÊÎÑÒÈ È ...

СИСТЕМА ДЛЯ ИЗВЛЕЧЕНИЯ ОБРАЗЦОВ ЖИДКОСТИ ТЕЛА И МОНИТОРИНГА АНАЛИТА В НЕЙ, УСТРОЙСТВО И СПОСОБ ИЗВЛЕЧЕНИЯ ВНУТРИТКАНЕВОЙ ЖИДКОСТИ

ÐÎÑÑÈÉÑÊÀß ÔÅÄÅÐÀÖÈß (19) RU (51) ÌÏÊ 7 (11) 2004 117 068 (13) A A 61 B 5/15 ÔÅÄÅÐÀËÜÍÀß ÑËÓÆÁÀ ÏÎ ÈÍÒÅËËÅÊÒÓÀËÜÍÎÉ ÑÎÁÑÒÂÅÍÍÎÑÒÈ, ÏÀÒÅÍÒÀÌ È ÒÎÂÀÐÍÛÌ ÇÍÀÊÀÌ (12) ÇÀßÂÊÀ ÍÀ ÈÇÎÁÐÅÒÅÍÈÅ (21), (22) Çà âêà: 2004117068/14, 04.06.2004 (71) Çà âèòåëü(è): ËÀÉÔÑÊÅÍ, ÈÍÊ. (US) (30) Ïðèîðèòåò: 06.06.2003 US 60/476,733 28.08.2003 US 10/653,023 (43) Äàòà ïóáëèêàöèè çà âêè: 20.11.2005 Áþë. ¹ 32 (54) ÑÈÑÒÅÌÀ ÄËß ÈÇÂËÅ×ÅÍÈß ÎÁÐÀÇÖΠÆÈÄÊÎÑÒÈ ÒÅËÀ È ÌÎÍÈÒÎÐÈÍÃÀ ÀÍÀËÈÒÀ  R U Ôîðìóëà èçîáðåòåíè 1. Ñèñòåìà äë èçâëå÷åíè îáðàçöîâ æèäêîñòè òåëà è ìîíèòîðèíãà àíàëèòà â íåé, ñîäåðæàùà îäíîðàçîâûé êàðòðèäæ, âêëþ÷àþùèé â ñåá áëîê îòáîðà îáðàçöîâ, âûïîëíåííûé ñ âîçìîæíîñòüþ èçâëå÷åíè îáðàçöà æèäêîñòè òåëà èç òåëà, è áëîê àíàëèçà, âûïîëíåííûé ñ âîçìîæíîñòüþ èçìåðåíè àíàëèòà â îáðàçöå æèäêîñòè òåëà, è áëîê ëîêàëüíîãî êîíòðîëëåðà, èìåþùåãî ýëåêòðîííóþ ñâ çü ñ îäíîðàçîâûì êàðòðèäæåì, ïðè÷åì ëîêàëüíûé êîíòðîëëåð âûïîëíåí ñ âîçìîæíîñòüþ ïðèåìà äàííûõ èçìåðåíè èç áëîêà àíàëèçà è ñîõðàíåíè äàííûõ. 2. Ñèñòåìà ïî ï.1, â êîòîðîé áëîê îòáîðà îáðàçöîâ âûïîëíåí ñ âîçìîæíîñòüþ èçâëå÷åíè îáðàçöà âíóòðèòêàíåâîé æèäêîñòè (ÂÒÆ) è èçìåðåíè ãëþêîçû â îáðàçöå ÂÒÆ. 3. Ñèñòåìà ïî ï.2, â êîòîðîé áëîê îòáîðà îáðàçöîâ âêëþ÷àåò â ñåá ïðîíèêàþùèé ýëåìåíò, âûïîëíåííûé ñ âîçìîæíîñòüþ ïðîíèêíîâåíè â öåëåâóþ îáëàñòü ñëî êîæè ïîëüçîâàòåë è, âïîñëåäñòâèè ïîñòî ííîãî íàõîæäåíè â ñëîå êîæè ïîëüçîâàòåë è èçâëå÷åíè îáðàçöà ÂÒÆ èç íåå, è ïî ìåíüøåé ìåðå, îäíî ïðèæèìíîå êîëüöî, âûïîëíåííîå ñ âîçìîæíîñòüþ ïðèëîæåíè äàâëåíè ê ñëîþ êîæè ïîëüçîâàòåë â íåïîñðåäñòâåííîé áëèçîñòè îò öåëåâîé îáëàñòè, â òî âðåì êàê ïðîíèêàþùèé ýëåìåíò íàõîäèòñ â ñëîå êîæè ïîëüçîâàòåë , ïðè÷åì áëîê îòáîðà îáðàçöîâ âûïîëíåí òàêèì îáðàçîì, ÷òî ïðèæèìíîå êîëüöî âûïîëíåíî ñ âîçìîæíîñòüþ ïðèëîæåíè äàâëåíè â âèäå êîëåáàíèé, ïîñðåäñòâîì ÷åãî ñãëàæèâàåòñ ñäâèã ãëþêîçû ÂÒÆ îáðàçöà ÂÒÆ, èçâëå÷åííîãî ïðè ïîìîùè ïðîíèêàþùåãî ýëåìåíòà. 4. Ñèñòåìà ïî ï.1, â êîòîðîé îäíîðàçîâûé êàðòðèäæ è ëîêàëüíûé êîíòðîëëåð âûïîëíåíû ñ âîçìîæíîñòüþ íîøåíè íà òåëå. 5. Ñèñòåìà ïî ï.1, ...

Probenentnahmevorrichtung für Körperflüssigkeit

Vorrichtung zum Ausdrücken von Körperflüssigkeit aus einem in der Hautoberfläche gebildeten Einschnitt, die aufweist: ein Gehäuse mit einem Ende; ein Einweglanzettenelement, das im Gehäuse angeordnet ist; und ein Stimulatorelement mit einem ersten Ende, das im Gehäuse angeordnet ist, und einem zweiten Ende, das angepasst ist, um über das Ende des Gehäuses hinaus zu ragen, wobei das Stimulatorelement in Längsrichtung relativ zum Gehäuse verschiebbar ist.

Blutlanzette

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.

Body fluid sampling device and methods of use

A device for sampling body fluid includes a housing (12) having a sleeve (102) at a forward end thereof which is displaceable in response to being pressed against a user's skin to trigger the firing of a lancet (150). After the lancet (150) is removed from the incision, the sleeve (102) is repeatedly pressed against the skin to depress a ring of body tissue in surrounding relationship to the incision to express body fluid outwardly through the incision. A pusher member (24) is then actuated to push a capillary tube (164) through a front end of the housing for drawing in body fluid. The lancet (150) is a disposable lancet which includes a body supporting a skin lancing member (154) and the capillary tube (164). The disposable lancet (150) passes through an upper end of a lancet carrier (16) when being installed or removed. The device cannot be armed until the disposable lancet (150) is installed in the housing (12), because the capillary tube (164) functions to push a safety device to a ...

Devices, systems, and methods for sample collection

POLYGONAL ONE LANZETTENNADEL

BLUTLANZETTE.

BLUTLANZETTE.

DIAGNOSTIC A-PAINT-HURRY

SELFOPTIMIZING LANZETTENVORRICHTUNG WITH ADAPTATION MEANS FOR TEMPORAL FLUCTUATIONS OF SKIN CHARACTERISTICS

Method and apparatus for improving success rate of blood yield from a fingerstick

Medical device package, kit and associated methods

Multiple tip lancet

Device for enhancing transdermal agent delivery or sampling

Methods and apparatus for sampling and analyzing body fluid

Systems and methods for the transport of fluids through a biological barrier andproduction techniques for such systems

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.

ELICITING A BLOOD SAMPLE

Apparatus (100) for eliciting a blood sample, the apparatus compris¬ ing a testing member (208) rotatably mounted on a shaft (204) and an aperture (105) for positioning a body part of the user relative to the edge (305) of the testing member wherein an edge of the testing member is shaped such as repeatedly to exert pressure on the skin of a user when the testing member is rotated.

SAMPLE CAPTURE IN ONE STEP FOR TEST STRIPS

A test strip is provided with sample capture that provides for a one step process to achieve a lancing event, sample capture and sample transport in a sensor design that supports one step testing. In various embodiments, the present invention provides for one step testing by, (i) analyte sample capture layout; (ii) analyte sample capture and transport configurations; (iii) structures of sample capture; (iv) processes for forming sample transport, and the like.

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.

Rapid blood expression and sampling

The invention relates to rapid blood expression and sampling. Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, the device further comprising a fluid receiving means remotely spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.

Devices, systems, and methods for sample collection

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 ...

Lancet system

TOe invention concerns a lancet system comprising a plurality of essentially needle-shaped lancets, a drive unit which has a drive element which is moved from a resting position into a lancing position in order to carry out a lancing process, a storage area to store the lancets, a withdrawal area to guide at least the tip of the lancet out of the system during the lancing process and a transport unit which can transport lancets from the storage area into the withdrawal area, wherein the drive element is arranged in such a manner that in the withdrawal area it can act on the lancet located there to carry out a lancing process and thus move the lancet from a resting position into a lancing position and wherein the system has a retraction device in the withdrawal area which can interact with the lancet located in the withdrawal area in order to move the lancet after completion of the lancing process from the lancing position into the resting position and it concerns a lancet magazine adapted ...

Method and apparatus for penetrating tissue

A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

"blood sample collection apparatus and kits"

Blood sample collection apparatus and kits are devised as easy-to-use, reduced pain devices operable by persons not having medical training or other expertise or knowledge. A flexible strip having adhesives on two portions of a first side accommodate therebetween and absorbent pad and substrate with microstructures. The substrate includes microstructures arranged to gently penetrate or pierce skin and cause a small amount of blood to pass to the external surface of a user's flesh. An absorbent pad receives and absorbs a blood sample therein. The absorbent pad may additionally support a plurality of chemical agents which further advances mobility of blood in the collection system. These chemical agents may include anticoagulants and blood anticlotting agents to facilitate blood transfer from a donor to the absorbent pad. Additionally, these systems may also include a blood preservative to stabilize blood collected for an extended shipping and transfer period. These blood sample collection ...

СИСТЕМА ВЫЯВЛЕНИЯ АНАЛИЗИРУЕМОГО ВЕЩЕСТВА, СПОСОБИССЛЕДОВАНИЯ КОНЦЕНТРАЦИИ АНАЛИЗИРУЕМОГО ВЕЩЕСТВА

Изобретение относится к медицинской диагностике. Система использует индикаторную полоску для анализируемого вещества, включающую в себя биодатчик и ланцет. Объединение элементов ланцета и датчика устраняет необходимость совмещать датчик с образцом биологической жидкости после того, как ланцет и вскрывающее устройство используются в комбинации для прокалывания кожи. Система включает устройство, содержащее две части корпуса, которые скользят относительно друг друга и для взведения, и для выпуска индикаторной полоски на целевом участке. В устройстве используют накопитель, загруженный испытательными полосами, причем каждый раз, когда устройство приводят в действие, из накопителя берется одна полоса. Раскрыт способ включения анализируемого вещества с использованием системы. Изобретения позволяют получить и исследовать образцы биологической жидкости с минимальным объемом работы пользователя. 2 н. и 7 з.п. ф-лы, 12 ил.

СИСТЕМА ДЛЯ ОБНАРУЖЕНИЯ АНАЛИТА В ЖИДКОСТИ ТЕЛА

... 1. Система (110) для определения по меньшей мере одного аналита в жидкости тела, в частности для определения уровня глюкозы в крови, причем указанная система (110) выполнена с возможностью генерации образца (130) жидкости тела и по меньшей мере частичного переноса указанного образца в по меньшей мере один тестовый элемент (128), в частности, в область (129) тестирования, причем система (110) выполнена таким образом, что период времени между генерацией образца (130) и нанесением на тестовый элемент (128) составляет менее 1 с, предпочтительно менее 500 мс. ! 2. Система (110) по п.1, причем система (110) выполнена с возможностью выполнения переноса образца (130) в тестовый элемент (128) с помощью одного или нескольких следующих средств: ! с помощью по меньшей мере одного капилляра (132); ! с помощью по меньшей мере одного ланцета (120), выполненного по меньшей мере частично в виде капилляра (132), в частности в виде частично открытого капилляра (132), в частности ланцета (120) со встроенным ...

УПАКОВКА ДЛЯ МЕДИЦИНСКОГО УСТРОЙСТВА, КОМПЛЕКТ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ

... 1. Упаковка для медицинского устройства, содержащая основной закупоривающий элемент с выполненной в нем выемкой, причем основной закупоривающий элемент включает проксимальный конец и дистальный конец, вспомогательный закупоривающий элемент, в котором выемка имеет проем выемки на проксимальном конце основного закупоривающего элемента, выемка конфигурирована для, по меньшей мере, частичного приема и прочного удерживания в ней с возможностью освобождения медицинского устройства и вспомогательный закупоривающий элемент, выполненный для закупоривания проема выемки, когда медицинское устройство вставлено в выемку. 2. Упаковка для медицинского устройства по п.1, в которой основной закупоривающий элемент включает, по меньшей мере, один боковой канал, при этом медицинское устройство прочно и с возможностью извлечения удерживается за счет трения между медицинским устройством и, по меньшей мере, одним боковым каналом. 3. Упаковка для медицинского устройства по п.1, в которой основной закупоривающий ...

PRAEZISIONSSCHNEPPER ZUM SETZEN VON NORMSTICHWUNDEN IN DIE HAUT FUER DIAGNOSEZWECKE

Apparatus and method for incising

A multi-shaft apparatus, for incising a substrate of soft resilient material such as a body tissue, particularly for collecting a blood sample, comprises two or more incision shafts 112, 114 each having a distal edge 118, 128. The shafts 112, 114 are not affixed to each other and are allowed to slide against each other to drive the distal edges 118, 128 alternately against the substrate to incise the substrate by, for example, a pizoelectric mechanism. In the case of incising a body tissue, such alternating motion results in less pain to the patient than a puncture resulting from a sharp jab by a sharp shaft of similar size to the shafts 112, 114. In a further embodiment, (Fig 8) the outer shaft is blunt and stationary whilst the inner shaft cuts by rotating motion. In another embodiment, (Fig 9) the shafts comprise a single tube split in two.

Blood and interstitial fluid sampling device

Devices, systems, and methods for sample collection

A handheld device 100 for collecting a blood sample from a subject comprises a housing having a base 132 which is placed on the skin of the subject. An interface e.g. button 167 on the housing is moved in a first direction in order to activate one or more piercing elements 158 that are extendable in a second direction through an opening 140 of the housing. The second direction is different to the first direction e.g. non-parallel, orthogonal, oblique. By moving the interface in a direction different to the direction of the piercing elements the perception of pain may be reduced. Skin is drawn into a recess 136 in the base of the housing under vacuum. An interface 115 may be provided for manually activating the vacuum, or it may be automatic upon sensing that the device has been placed on skin.

ANALYZER AT MINIMUM HANDLING EXPENDITURE

EQUIPMENT FOR THE INCREASE OF THE SUCCESS RATE REGARDING THE BY A FINGER PASS PRESERVATION BLOOD YIELD

SERVOMECHANISM FOR PRODUCING HOLES.

HANDHELD MEDICAL DIAGNOSTIC DEVICES WITH LANCING SPEED CONTROL

A method of controlling lancing speed of a lancet structure of a portable handheld medical diagnostic device (10) includes providing an elongated lancet structure (24; 406; 432; 450; 506; 606) having a skin piercing end (90; 408; 434; 462; 508; 608) and a blood transport portion (92; 464; 510; 610) adjacent the skin piercing end (90; 408; 434; 462; 508; 608). The skin piercing end (90; 408; 434; 462; 508; 608) when displaced makes an incision at a skin site to produce an amount of bodily fluid from the skin site and in which the blood transport portion (92; 464; 510; 610) transports the amount of bodily fluid away from the skin site for use by a measurement system (32) in making a physiological measurement. A spring-driven motor assembly (144) is operatively connected to the lancet structure (24; 406; 432; 450; 506; 606). The spring-driven motor assembly (144) displaces the lancet structure (24; 406; 432; 450; 506; 606) toward the skin site to make the incision for producing the amount ...

LIQUID SAMPLE MEASUREMENT DEVICE

This liquid sample measurement device is provided with: a lancet mounting part to and from which a lancet device having a skin contact section for puncturing skin can be attached and detached; a sensor mounting part to which a biosensor, which is spotted with blood that comes out from the punctured skin, can be attached; and a measurement part that uses the biosensor attached to the sensor mounting part to measure the amounts of substances in the blood. The liquid sample measurement device includes a feature that makes it necessary to replace a lancet device that has been attached to the lance mounting part and has punctured skin, each time a lancet device is used to puncture skin.

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.

DEVICE FOR ENHANCING TRANSDERMAL AGENT DELIVERY OR SAMPLING

A percutaneous agent delivery or sampling device (10, 88, 98, 104) comprisin g a sheet (6) having a plurality of microblades (4) for piercing and anchoring to the skin for increasing transdermal flux of an age nt and for improving the attachment of the device (10, 88, 98, 104) to the skin. The device comprises a sheet (6) having at least one openi ng (8) therethrough and a plurality of blades (4) extending downward therefrom, and an anchoring means for anchoring the device (2) to t he body surface.

SEE DANS LA PEAU EN VUE D'UN DIAGNOSTIC

Pour effectuer une petite piqûre ou coupure standardisée, en vue de mesurer le temps de saignement, le dispositif comporte une masse d'équilibrage 13 partant en sens inverse de la lancette 2 lors du déclenchement, et un ressort de rappel 18 pour que l'instrument ne reste pas dans la plaie. Les blessures etant standardisées, on peut faire des études comparatives valables.

AIGUILLE OBTENUE EN UNE SEULE PIECE D'UNE MATIERE SYNTHETIQUE ET DESTINEE A PROVOQUER L'APPARITION D'UNE GOUTTE DE SANG

L'AIGUILLE EST DESTINEE A ETRE ENFONCEE A TRAVERS LA PEAU D'UN PATIENT POUR PROVOQUER L'APPARITION EN SURFACE D'UNE GOUTTE DE SANG ET ELLE EST DU TYPE COMPRENANT UN CORPS 1, UNE EXTREMITE POINTUE 4 ET UN ENTOURAGE DE PROTECTION 5, LE TOUT OBTENU PAR MOULAGE EN UNE SEULE PIECE D'UNE MATIERE SYNTHETIQUE. ELLE EST CARACTERISEE EN CE QUE L'EXTREMITE POINTUE 4 PRESENTE LA FORME D'UN VOLUME A PAROI(S) A GENERATRICE(S) CONVERGEANT VERS UN SOMMET 17, MAIS LIMITE PAR UNE FACE 18 SITUEE DANS UN PLAN PASSANT PAR LE SOMMET 17 ET CONTENANT L'AXE VIRTUEL Y DUDIT VOLUME NON LIMITE, ET EN CE QUE L'ENTOURAGE 5 EST SEPARE DE L'EXTREMITE POINTUE 4 PAR UN ESPACE X ET POSSEDE, EN VUE DE SON RETRAIT POUR DEGAGER L'EXTREMITE POINTUE 4 LORS DE SON UTILISATION, DES POINTES CASSANTES 8 ET 9 RELIEES AU CORPS 1 DE L'AIGUILLE, LOIN DE LADITE EXTREMITE POINTUE 4.

Puncture needle, and method and device for producing same

RAPID BLOOD EXPRESSION AND SAMPLING

DEVICE TO CROSS THE CORNEOUS LAYER OF A CORPORAL SURFACE AND METHOD OF SAMPLING TRANSDERMICO WITH THE SAME

Un dispositivo de administración o muestreo percutáneo de agente que comprende una lámina que tiene una pluralidad de microcuchillas para atravesary anclar a la piel para aumentar el caudal transdérmico de un agente y para mejorar lavincu lación del dispositivo a la piel; y un método de muestreotrasdérmico con el mismo.

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.

Simultaneous acquisition of biometric data and nucleic acid

Disclosed are devices and methods for collection and analyzing biological samples containing nucleic acid in conjunction with collecting at least one ridge and valley signature of a test subject, while keeping the sample and signature associated with each other. Such devices and methods are used in forensic, human identification, screening, and access control technologies to rapidly process an individual's identity or determine the identity of an individual.

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.

Apparatus and method for manually powered bodily fluid extraction

Apparatuses and methods are disclosed herein for extracting bodily fluids. The apparatus consists of a housing, a releasable lancet stored in the housing, an inlet flow channel formed in the housing, a mechanically powered vacuum generator, and a storage area formed in the housing. The releasable lancet is released to pierce the skin of the subject to allow fluid to be extracted from the subject. The vacuum generator generates a partial vacuum within the inlet flow channel. After the lancet has pierced the skin of the subject, the partial vacuum draws fluid from the subject and into the inlet flow channel. The storage area is in fluid connection with the inlet flow channel, and receives the fluid drawn from the subject from the inlet flow channel.

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.

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.

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 ...

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 ...

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.

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 ...

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 ...

BLOOD PICKER

A blood picker including one or more needles, a storage device, and a fluid transmission control system is provided. The needle is adapted to be inserted into a blood vessel of a human for blood detection. The storage device is in communication with the needle and provided with a drawing tube in communication with an inner space of the storage device. The fluid transmission control system includes a fluid transmission device, a driving controller, and a power supply. The fluid transmission device is in communication with one end of the drawing tube. The power supply provides a power source for the driving controller to enable the fluid transmission device, so that after the fluid transmission device is enabled, the inner space of the storage device is controlled by the fluid transmission device to generate a pressure difference, thereby allowing the blood to be drawn and stored in the storage device. 1. A blood picker adapted to draw blood from a human for blood detection , wherein the blood picker comprises:at least one needle adapted to be inserted into a blood vessel of the human for blood detection;a storage device in communication with the at least one needle, wherein the storage device is adapted to collect the blood and provided with a drawing tube in communication with an inner space of the storage device; anda fluid transmission control system comprising a fluid transmission device, a driving controller, and a power supply, wherein the fluid transmission device is in communication with one end of the drawing tube for drawing the fluid in the inner space of the storage device; and the power supply is provided with a power source for the driving controller to enable the fluid transmission device, so that after the fluid transmission device is enabled, the inner space of the storage device is controlled by the fluid transmission device to generate a pressure difference with respect to the outside environment of the storage device, thereby allowing the blood in ...

Simultaneous acquisition of biometric data and nucleic acid

Disclosed are devices and methods for collection and analyzing biological samples containing nucleic acid in conjunction with collecting at least one ridge and valley signature of a test subject, while keeping the sample and signature associated with each other. Such devices and methods are used in forensic, human identification, screening, and access control technologies to rapidly process an individual's identity or determine the identity of an individual.

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 ...

COMBINATION BLOOD LANCET AND ANALYZER

Methods and systems for collecting and analyzing blood are provided. The methods and systems generally operate by collecting a blood sample on a portion of a lancet and subjecting the blood sample to optical spectroscopy. 1. A method of collecting and analyzing blood , said method comprising:cutting the skin of a subject with a lancet;collecting a blood sample of the subject with the lancet;passing light through the blood sample on the lancet; andcollecting the light passed through the blood sample with an optical spectrometer for analysis of the blood sample.2. The method of claim 1 , wherein the method further comprises allowing the liquid blood sample to dry on the lancet to form a dried blood sample.3. The method of claim 2 , further comprising subjecting the dried blood sample to optical spectroscopy.4. The method of claim 1 , wherein collecting the blood sample of the subject with the lancet comprises collecting a volume of less than 10 μL of blood.5. The method of claim 1 , wherein collecting the blood sample of the subject with the lancet comprises collecting a volume of less than 5 μL of blood.6. The method of claim 1 , wherein collecting the blood sample of the subject with the lancet comprises collecting a volume of less than 1 μL of blood.7. The method of claim 2 , further comprising subjecting the dried blood sample to infrared spectroscopy.8. The method of claim 2 , further comprising subjecting the dried blood sample to mid-infrared spectroscopy.9. The method of claim 1 , further comprising conducting optical spectroscopy upon a plurality of dried blood samples obtained from a plurality of subjects to obtain a plurality of dried blood spectra.10. The method of claim 9 , further comprising constructing a model from the plurality of dried blood spectra.11. The method of claim 10 , wherein the model is constructed using one or more multivariate least squares methods.12. The method of claim 10 , wherein the model is constructed using an augmented ...

LIQUID SAMPLE MEASUREMENT DEVICE WITH REMOVABLE LANCET OR BIOSENSOR

This liquid sample measurement device is provided with: a lancet mounting part to and from which a lancet device having a skin contact section for puncturing skin can be attached and detached; a sensor mounting part to which a biosensor, which is spotted with blood that comes out from the punctured skin, can be attached; and a measurement part that uses the biosensor attached to the sensor mounting part to measure the amounts of substances in the blood. The liquid sample measurement device includes a feature that makes it necessary to replace a lancet device that has been attached to the lance mounting part and has punctured skin, each time a lancet device is used to puncture skin. 1. A liquid sample measurement device to which a biosensor may be removably attached , the biosensor having a blood sample deposited on it created by a puncturing of a skin , the liquid sample measurement device comprising:a sensor port to which the biosensor is removably attached;a measuring sensor configured to measure an amount of a substance in the blood sample and produce a first measurement by applying a voltage or a current to electrodes of the biosensor; anda display section configured to display the first measurement of the measuring sensor;a sensor wearing detecting section configured to detect whether or not the biosensor is attached to the liquid sample measurement device and transmit a result of the detection; anda controller configured to control the measuring sensor,the controller receives the result of the detection from the sensor wearing detecting section after the measuring sensor measures the blood sample and produces the first measurement, and makes the display section display instructing removing the biosensor continuously and prohibits from proceeding to a next step unless a user removes the biosensor from the liquid sample measurement device.2. The liquid sample measurement device according to claim 1 , whereinthe controller inquires the sensor wearing detecting ...

TEST CARTRIDGE AND LANCET FOR AUTOMATED MEDICAL SAMPLE COLLECTION AND TESTING

A disposable lancet assembly includes: a spring aligned along a linear axis; a lancet aligned along the linear axis adjacent to the spring; a needle cup aligned along the linear axis adjacent to the lancet; and a housing including a channel that accepts an actuator interface such that the needle cup and lancet are able to be moved along the linear axis via the actuator interface. A medical test cartridge includes: a bottom plate; a microfluidic chip; and a top plate, wherein the top plate is coupled to the bottom plate such that the microfluidic chip is retained between the top plate and the bottom plate. A sample collection and testing device includes: a lancet assembly; a lancet actuator coupled to the lancet assembly; and a microfluidic test chip. 1. A disposable lancet assembly comprising:a spring aligned along a linear axis;a lancet aligned along the linear axis adjacent to the spring;a needle cup aligned along the linear axis adjacent to the lancet; anda housing comprising a channel that accepts an actuator interface such that the needle cup and lancet are able to be moved along the linear axis via the actuator interface.2. The disposable lancet assembly of claim 1 , wherein the lancet comprises a cylindrical body claim 1 , the housing is cylindrical claim 1 , and the channel runs along the linear axis.3. The disposable lancet assembly of further comprising a support plate coupled to the housing claim 1 , the support plate comprising a needle guide aligned with the lancet along the linear axis.4. The disposable lancet assembly of further comprising a microfluidic chip claim 1 , a top support plate claim 1 , and a disposable cover.5. The disposable lancet assembly of claim 1 , wherein the lancet comprises a cylindrical body and a needle partially embedded into the cylindrical body.6. The disposable lancet assembly of claim 1 , wherein the needle cup has a cylindrical body that partially encloses the cylindrical body of the lancet. The disposable lancet assembly ...

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 ...

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.

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。

Apparatus and method for incising

A multi-shaft apparatus for incising a substrate of soft resilient material such as a body tissue. The incising apparatus includes two or more incision shafts each having a distal edge. The shafts are not affixed to each other and are allowed to slide against each other to drive the distal edges alternately against the substrate to incise the substrate. In the case of incising a body tissue, such alternate motion would result in less pain to the patient than a puncture resulting from a sharp jab by a sharp shaft of similar size to the shafts.

Tissue penetration device

A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

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.

Tissue penetration device

An agent injection device is provided that is capable of injecting an agent to a known predetermined tissue depth. An injection member has an elongate injection shaft with an outlet port configured to dispense an agent at a controllable time. A controllable driver is coupled to the elongate injection shaft and is configured to drive the injection member into target tissue. A velocity control system is in communication with the controllable driver and is configured to control the velocity of the elongate injection shaft.

Body fluid sampling module with a continuous compression tissue interface surface

A body fluid sampling device includes a housing, a penetrating member positioned in the housing and a test strip. A compliant front end is coupled to the housing. The compliant front-end includes a rigid member with an interior aperture to receive the body fluid from a wound site.

Body fluid sampling device with a capacitive sensor

A body fluid sensing device with a body fluid capture structure and a body fluid measurement sensor positioned in the body fluid capture structure. A capacitance sensor is coupled to the body fluid measurement sensor. The capacitance sensor is used to assist in the positioning of a body part relative to the body fluid capture structure.

Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing

A device for use with a penetrating member driver to penetrate tissue is provided. The device includes a single cartridge coupled to a plurality of penetrating members and operatively couplable to the penetrating member driver. The penetrating members are movable to extend radially outward from the cartridge to penetrate tissue. A plurality of optical analyte sensors are coupled to the single cartridge and positioned to receive body fluid from a wound in the tissue created by the penetrating member.

Method and apparatus for penetrating tissue

A tissue penetrating system has a housing member, a plurality of penetrating members positioned in the housing member and a plurality of sample chambers. Each sample chamber is associated with a penetrating member. A tissue stabilizing member has a tissue interface surface configured to be applied to a tissue surface and provide for spontaneous flow of blood for sample capture. The tissue stabilizing member is coupled to the housing.

Method and apparatus for penetrating tissue

A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Method and apparatus for penetrating tissue

A skin penetrating system is provided with a drive force generator and a disposable housing member. A plurality of penetrating members are positioned in the disposable housing member. Each penetrating member is coupled to the drive force generator. A plurality of analyte detecting members are each associated with a penetrating member and are positioned in the disposable housing member. Each analyte detecting member is positioned in a sample chamber with a volume of less than 1 μL, The sample chambers have openings for transport of a body fluid into the sample chamber. Each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

Tissue penetration device

A body fluid sampling system is provided for use on a tissue site. A drive force generator is coupled to penetrating members. The penetrating members are at least partially housed in a penetrating member housing. The penetrating member housing has openings for the penetrating members. The penetrating members are launched along a launch path by the drive force generator through an opening in the penetrating member housing. Analyte sensors are housed in a analyte sensor housing. Each analyte sensor is associated with a penetrating member. The analyte sensor housing and the penetrating member housing are coupled to provide that each analyte sensor is positioned out of a launch path of a penetrating member. The analyte sensor housing includes desiccant pockets for receiving desiccant plugs.

Tissue penetration device

A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

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.

Method and apparatus for an improved sample capture device

A body fluid sampling device is provided. A mesh may be used to guide blood or fluid to travel directly from the wound to an analyte detecting port on the cartridge. Thus the volume of blood or body fluid produced at the wound site irregardless of its droplet geometry can be reliable and substantially completely transported to the analyte detecting member for measurement.

Method and apparatus for a variable user interface

An analyte monitoring system is provided. The system may include a housing (200) and a visual display (206) on the housing (200), the visual display (206) having at lease one visual indicator position next to a corresponding marking (208, 210, 212, 214 and 216) on the housing (200). The system may include a processor (60) driving the visual display (206), wherein the processor (60) runs software that is modifiable to provide a variable user interface on the visual display (206). The system may include a wireless communication to allow applets or programs to be downloaded by the processor (60).

Method and apparatus for improving fluidic flow and sample capture

A system and method is provided for the capture of bodily fluid upon lancing of a patient. In one embodiment, the fluid sample capture aperture mesh ( 320 ) ring is placed in the pathway of a finger penetrating member ( 340 ). The aperture mesh ring has a center clearance area that allows the penetrating member to pierce the skin unobstructed. The aperture mesh ring may contain a series of fluid sampling meshes as to allow the release bodily fluid to “wick” into the fluid sampling meshes for transport to the respective sensor. The invention may also relate to a method of improving the fluidic flow through a membrane mesh structure for the transportation of bodily fluids from a point of sampling to a point of measurement.

Method and apparatus for a fluid sampling device

Method and apparatus for a fluid sampling device

A blood analyzer device has a housing with a top section coupled to a bottom section, a driver and a plurality of penetrating members housed in a disposable positionable in the housing. A gripper engages each penetrating member. A manually actuated button advances the disposable to move penetrating members into launch positions. A power is source coupled to the driver. A display is at the housing.

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.

Rapid blood pumping and sampling

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 and a processor coupled to the drive force generator capable of changing the direction and magnitude of force exerted on the lancet during the lancing cycle. The driver further includes a human interface on the housing providing at least one output for communicating with the patient.

APPARATUS FOR INCREASING THE SUCCESS RATE IN RESPECT OF BLOOD EXPLOITATION OBTAINED BY A FINGERSTICK

Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties

Tissue penetration device

A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

Device and method for variable speed lancet

A method of penetrating tissue is provided. The method uses a lancet driver to advance a lancet into the tissue; advancing the lancet at a first desired velocity in a first layer of tissue; advancing the lancet at a second desired velocity in a second layer of tissue; and advancing the lancet at a third desired velocity in a third layer of tissue. In one embodiment, the method may including using a processor having logic for controlling velocity of the lancet in each layer of tissue.

Fluid sampling device with improved analyte detecting member configuration

An assembly is described that combines blood chemical analysis with lancing in a single multiple-test disposable cartridge. The penetrating members can be assembled and sterilized without damaging the analytical chemistry, and the functioning of the present radical disc cartridge mechanism is not substantially modified.

Wearable device with microneedle array delivery system

A wearable device (204) comprising: a base coupled to a user; a recessed portion formed in the base; a microneedle array (200) supported by the base wherein the microneedle array includes a plurality of microneedles; and an actuator (208) coupled to the microneedle array to move the microneedle array into and out of the recessed portion in the base.

Device for enhancing transdermal release or sampling of drugs

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.

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.

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.

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.

Analyte sensor inserter

Medical device inserters and processes of inserting and using medical devices

An apparatus including a sheath defining a distal surface for placement on a skin surface, a device support movable between a proximal and distal position, and adapted to support a medical device, a sharp support movable between a proximal position and a distal position and adapted to support a sharp for inserting the medical device under the skin surface and extending through a portion of the 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 under the skin surface, and a driver for advancing the sharp support towards the proximal position when the sharp support reaches the distal position.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 methods of inserting medical devices.

Extruded electrode structures and methods of using same

The present disclosure provides electrode structures and integrated electrode structures having one or more conductive materials coextruded with one or more dielectric materials. The disclosed electrode structures can be configured for use as analyte sensors. Also provided, are methods of making and using the electrode structures and integrated electrode structures described herein.

Lancet for capillary puncture blood samples

A lancet for obtaining a drop of blood by capillary puncture is formed by a needle having a coating thereon of a composition which precludes contact clotting activation of the blood sample.

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, 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.

For the microsensor on the human body of biological monitoring

一种微传感器及微传感器的制造方法，包括丝状体阵列，其中丝状体阵列的每个丝状体包括基体和耦合到基体且被配置成用于促进分析物检测的导电层。丝状体阵列的每个丝状体可进一步包括配置成隔离由导电层界定的用于分析物检测的区域的绝缘层、配置成实现将离子浓度转换为电子电压的耦合到导电层的传感层和配置成便于特定目标分析物/离子的检测的耦合到传感层的选择性涂层。该微传感器有利于与微传感器交互地检测使用者的体液中存在的至少一种分析物。

Inserter device including rotor subassembly

An inserter subassembly including a rotor and drive member such that rotation of the rotor is translated to a linear motion including insertion and refraction paths.

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.

Devices and methods for glucose measurement using rechargeable battery energy sources

An analyte measurement device has a housing and a visual display on said housing. The visual display has at lease one visual indicator position next to a corresponding marking on the housing. A processor drives the visual display and runs software that is modifiable to provide a variable user interface on the visual display. A rechargeable battery is provided.

Method and apparatus for analyte measurement test time

A method is provided for the analyte measurement by a user using an analyte measurement device. A penetrating member and unused analyte detecting member of the analyte measurement device are presented into an active position. The penetrating member is fired to prick the skin and bring a fluid sample to the analyte detecting member. The analyte level is measured. These three steps occur in less than 10 seconds.

Tissue Penetrating Apparatus

A body fluid sampling system is provided for use on a tissue site. A drive force generator is provided. A housing has at least a first handle portion with a first average diameter, and a head portion with a second average diameter that is larger than the first average diameter. The housing includes a plurality of analyte sensors and a plurality of sample chambers. Each analyte sensor is associated with a sample chamber and is configured to receive body fluid from a wound in tissue created by a penetrating member. A plurality of penetrating members are operatively coupled to the drive force generator. The drive force generator moves each of the penetrating members along a path out of the housing into the tissue site, stops in the tissue site, and withdraws out of the tissue site. Each penetrating member is at least partially positioned adjacent to an analyte sensor in a sample chamber.

Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein

An interstitial fluid (ISF) extraction device includes a penetration member configured for penetrating a target site of a user's skin layer and, subsequently, residing in the user's skin layer and extracting an ISF sample therefrom and at least three concentrically-arranged pressure rings, each adapted for applying pressure to the user's skin layer in the vicinity of the target site while the penetration member is residing in the user's skin layer. In addition, the ISF extraction device is configured such that (i) the pressure rings apply pressure in an oscillating manner with asymmetric deployment and retraction cycles and (ii) only one of the at least three concentrically-arranged pressure rings is deployed at a time, thereby mitigating an ISF glucose lag of the ISF sample extracted by the penetration member.

Method and apparatus for a multi-use body fluid sampling device

A device for use in penetrating tissue to obtain a body fluid sample is provided. A cartridge may be included. A plurality of penetrating members are slidably coupled to the cartridge. Each penetrating member has a distal end that is sufficiently sharp to pierce tissue. Each penetrating member may be moveable relative to the other ones of the penetrating members so that the sharpened distal ends extend radially outward to penetrate tissue. The penetrating members are elongate members without molded attachments.

Method and apparatus for improving success rate of blood yield from a fingerstick

Blood samples can be collected without substantial contamination from ambient air, such that the blood sample may be analysed accurately for gaseous components such as oxygen and carbon dioxide. An embodiment of the device has integrated actuation, lancing, and sample acquisition components, which in some embodiments are miniatuized and/or disposable.