КАТЕТЕР ДЛЯ ИНЪЕКЦИЙ, ИСПОЛЬЗУЕМЫЙ ДЛЯ ПОДАЧИ ТЕРАПЕВТИЧЕСКОГО СРЕДСТВА В СУБСТРАТ

Изобретение относится к медицинской технике, а именно к катетерам для инъекций, и в частности, к катетерам для инъекций, используемым для подачи терапевтического средства в субстрат. Катетер для инъекций, используемый для подачи терапевтического средства в субстрат, содержит по меньшей мере одну полость, имеющую открытый дистальный конец, и изогнутый подающий элемент, выполненный с возможностью удлинения внутри субстрата. Указанная по меньшей мере одна полость выполнена с возможностью ее использования в качестве направляющего средства для изогнутого подающего элемента при размещении вне субстрата. Подающий элемент содержит полую трубку с дистальным отверстием и имеет по меньшей мере два отверстия, расположенные на его дистальном кончике. Дистальный кончик содержит дистальную область и проксимальную область. Удельная поверхность отверстий в дистальной области дистального кончика изогнутого подающего элемента больше, чем удельная поверхность указанных отверстий в проксимальной области дистального ...

УСТРОЙСТВО ДЛЯ АБЛЯЦИИ ТКАНИ С МЕХАНИЗМОМ ОБРАТНОЙ СВЯЗИ ОБРАЗОВАНИЯ ФОТОАКУСТИЧЕСКОГО УЧАСТКА ПОРАЖЕНИЯ

... 1. Устройство для абляции ткани, содержащее: ! по меньшей мере, один катетер (121, 221), вмещающий, по меньшей мере, один излучатель (21) энергии и, по меньшей мере, один фотоакустический датчик (22), согласованно скомпонованные для применения абляционной терапии ткани (60); ! при этом, по меньшей мере, один излучатель (21) энергии выполнен с возможностью испускания луча, иссекающего ткань (ИТ), внутрь целевого участка ткани (60) для образования в ней участка (61) поражения; ! надувной баллон (122, 222), прикрепленный к катетеру (121, 221) и окружающий, по меньшей мере, один излучатель (21) энергии и, по меньшей мере, один фотоакустический датчик (22), причем баллон (122, 222) выполнен с возможностью наполнения оптоакустической передающей средой (126, 226) посредством катетера (121, 221); ! по меньшей мере, один излучатель (21) энергии дополнительно выполнен с возможностью испускания фотовозбуждающего (ФВ) луча внутрь целевого участка ткани (60), чтобы вызвать фотоакустический отклик ткани ...

ИНЪЕКЦИОННЫЙ КАТЕТЕР ДЛЯ ВВЕДЕНИЯ ТЕРАПЕВТИЧЕСКОГО СРЕДСТВА В СУБСТРАТ

... 1. Катетер (1) для инъекций, используемый для подачи терапевтического средства в субстрат (12), содержащий по меньшей мере одну полость (14) и изогнутый подающий элемент (2), представляющий собой полую трубку,причем указанная по меньшей мере одна полость выполнена с возможностью ее использования в качестве направляющего средства для изогнутого подающего элемента (2) вне субстрата (12),подающий элемент (2) содержит отверстия (6), расположенные на его дистальном кончике (4), адистальный кончик (4) содержит дистальную область (10) и проксимальную область (8),отличающийся тем, чтоудельная поверхность отверстий (6) в дистальной области (10) дистального кончика (4) изогнутого подающего элемента (2) больше, чем удельная поверхность указанных отверстий в проксимальной области (8) дистального кончика (4) изогнутого подающего элемента (2).2. Катетер по п.1, отличающийся тем, что удельная поверхность в дистальной области (10) и в проксимальной области (8) дистального кончика составляет от 0,01 до ...

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

SYSTEMS AND PREPARATIONS TO THE MEDICINE DELIVERY TO INTERSTITIAL REGIONS OF THE MYOKARDIUMS

DEVICES FOR THE INTERSTITIAL INJECTION OF BIOLOGICAL ACTIVE SUBSTANCES IN FABRICS

DEVICE AND KIT FOR THE TREATMENT OF STÍRUNGEN OF THE HEART RHYTHM ADJUSTMENT SYSTEM

DEVICES FOR THE INTERSTITIAL INJECTION OF BIOLOGICAL MEANS IN FABRICS

EXPAND-CASH MEDICINE PRODUCT FOR THE TREATMENT OF HERZARRHYTHMIEN

ELECTRICALSURGICAL PROBE WITH A SHANK WITH A CHANNEL FOR LIQUIDS

EQUIPMENT FOR THE TREATMENT OF FABRIC WITH LIABILITIES INJECTION SYSTEMS

SYSTEMS AND PROCEDURES FOR THE ELECTRICALSURGICAL FABRIC TREATMENT IN PRESENCE ELECTRICAL OF LEADING LIQUIDS

CATHETER PURSUIT SYSTEM

DEVICE FOR REMOVING FROM MATERIALS FROM THE BODY

WITH PENETRATION DEPTH LIMITER MISTAKE SURGICAL DEVICE FOR PRODUCING CHANNELS

SYSTEM F�R INTERSTITIAL ONE TRANSVASKUL�RE SURGICAL INTERFERENCES

ARRANGEMENT FOR THE TREATMENT OF THE SKIN

DEVICE FOR PURPOSEFUL HEATING UP

LOCALLY FLEXIBLE ONE DILATORHÜLSE

CATHETER TO TRANSMYOKARDIALEN REVASKULARISATION

CATHETER PURSUIT SYSTEM

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

DEVICE FOR LOCKING THE PERSISTING FORAMEN OF OVALS

Method of inducing angiogenesis by micro-organs

Steerable catheter

Treatments for a patient with congestive heart failure

Devices, systems, and methods for accessing the epicardial surface of the heart

Devices, systems, and methods for accessing the internal and external tissues of the heart are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for localized delivery of leads to the heart tissue. In addition, various disclosed embodiments provide devices, systems, and methods for closing a hole in cardiac tissue.

FLEXIBLE POLYMER NEEDLE CATHETER

SEPTAL PUNCTURE DEVICE

CARDIAC HARNESS DELIVERY DEVICE

Methods and devices for accessing and delivering devices to a heart

Described here are devices, methods, and systems for accessing and delivering devices to a heart. Systems used to provide access to the heart via the left atrial appendage comprise a first access element with a first alignment member, a second access element with a second alignment member, a piercing element, an exchange element and may further comprise a left atrial appendage stabilization device. Methods of accessing and delivering devices to the heart via the left atrial appendage may comprise advancing a first access element into the left atrial appendage by an intravascular pathway and advancing a second access element towards the left atrial appendage through the pericardial space. The first and second alignment members form an attachment through the wall of the left atrial appendage so that the first and second access elements are aligned.

Methods and devices for treating atrial fibrillation

Described here are systems and methods for affecting tissue within a body to form a lesion. Some systems comprise tissue-affecting devices, devices that guide the advancement of the tissue-affecting elements to a target tissue region, devices that locate and secure tissue, and devices that help position the tissue-affecting devices along the target tissue. The methods described here comprise advancing a first tissue-affecting device to a first surface of a target tissue, advancing a second tissue-affecting device to a second surface of the target tissue, and positioning the first and second devices so that a lesion may be formed in the tissue between them. In some variations, the devices, systems, and methods described here are used to treat atrial fibrillation by ablating fibrillating tissue from an endocardial surface and an epicardial surface of a heart. Methods of closing, occluding, and/or removing the left atrial appendage are also described.

A maneuverable electrophysiology catheter for percutaneous orintraoperative ablation of cardiac arrhythmias

APPARATUS AND METHOD FOR THE MULTI-AXIAL PLACEMENT OF SURGICAL FASTENERS

Systems and methods for delivering beneficial agents into targeted tissue of a living being

A device, system and method for interstitial transvascular intervention

Self-sealing cannula

The present invention discloses a self-sealing cannula and methods of its use. The self-sealing cannula can be minimally invasively placed into the heart for drawing and/or returning blood with a self-sealing function at the interface of the blood access site. The disclosed cannula can be implemented as a single lumen cannula or a double lumen cannula, which can be used with ventricular assist devices for heart support or pump-oxygenators for ECMO and respiratory support. Through a self-sealing mechanism fixed on the ventricular wall or atrial wall, a cannula body is attached to the self-sealing fixture and blood is drawn into the lumen via an external pump and returned to the circulation system through a separate cannula. In the case of the double lumen cannula embodiment, the blood will be drawn into the drainage lumen of the double lumen cannula and returned through an infusion lumen at the desired location. The present invention achieves minimally invasive insertion without surgical ...

APPARATUS AND METHODS TO CREATE AND MAINTAIN AN INTRA-ATRIAL PRESSURE RELIEF OPENING

The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal. The present disclosure includes methods for creating and maintaining an opening in the 5 atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

System and method for cardiac dialysis

A system and method for treating a patient may include implanting an apparatus that includes a tube housing a one-way valve and having first and second surfaces. When the apparatus is implanted, the first surface is located inside the right atrium of the patient and the second surface is located on the skin of the patient. When implanted, the apparatus is used for drawing blood from the right atrium and/or providing a liquid to the patient. The apparatus may be designed to be hermetically sealed when disconnected from input and output lines.

Catheters and related devices for forming passageways between blood vessels or other anatomical structures

Mapping catheter

Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures

Apparatus and method for accessing the pericardial space

Intracardiac cell delivery and cell transplantation

Methods and apparatus for delivering medicament to tissue

Lasing device

Systems and methods for delivering drugs to selected locations within the body

Drug delivery module

Magnetically guided myocardial treatment system

Method and apparatus for advancing catheters

SYSTEM AND METHOD FOR FORMING A NON-ABLATIVE CARDIAC CONDUCTION BLOCK

A system forms a conduction block in a region of cardiac tissue at a location associated with a cardiac arrhythmia by delivering a material that is non- ablative into the region. The material includes living cells that do not form sufficient gap-junctions with cardiomyocytes to conduct, e.g. myoblasts, stem cells, or fibroblasts. The material may be a non-living agent, such as a polymer agent, e.g. fibrin glue agent or collagen agent. The material may be a combination of living and non-living material that enhances the cellular conduction block. A contact member (20, 420) delivers the material over a patterned region of tissue, such as arcuate, linear, or circumferential patterns. The contact member (20,420) may include an expandable member or balloon (430). A guidewire (480) may be used for delivery. Cells used may be autologous, prepared for injection with a kit. Conduction blocks are thus formed without substantially ablating cardiac tissue in the region.

PLACING A GUIDE MEMBER INTO THE HEART

A guide member (120) positioned through a coronary vessel, and the wall of the heart provides access to a heart chamber. A first end of the guide member (120) is passed through the coronary vessel, the heart wall into the heart chamber, and then is passed back out of the heart chamber. The end of the guide member (120) may then be used to deliver devices into the heart chamber to carry out various medical procedures. A conduit delivery system (110) is coupled to the end of the guide member, is delivered into the heart chamber, and then used to place a conduit in the heart wall to communicate the coronary vessel with the heart chamber.

METHODS AND DEVICES FOR ABLATION

An ablating device (522) has a cover (460) which holds an interface material such as a gel. The cover (460) contains the interface material during initial placement of the device (522). The ablating device (522) may also have a removable tip or a membrane (520) filled with fluid. In still another aspect the ablating device (522) may be submerged in liquid during operation.

TRANSSEPTAL CATHETERIZATION ASSEMBLY AND METHODS

Improved hand assemblies and methods combining a number of the separate known devices used in transseptal catheterization procedures, including sheaths, dilators, and needle assemblies (including a puncture device and a stylet, for example). The hand assemblies provide cooperating members that reduce the overall complexity and increase safety of transseptal catheterization procedures.

COAXIAL TRANSSEPTAL GUIDE-WIRE AND NEEDLE ASSEMBLY

A coaxial transseptal device (43) and methods of piercing a tissue within the heart (24). The coaxial transseptal device (43) includes a piercing device having a shaft with a distal sharpened portion. The coaxial transseptal device (44) also includes a coaxial guide-wire (46) configured to receive the piercing device (44) and move relative thereto. The flexibility of the coaxial guide-wire (46) increases from the proximal end to the distal end.

SYSTEM FOR PROVIDING ACCESS AND CLOSURE TO TISSUE

Embodiments are described for creating and closing tissue access ports or defects, such as transapical access ports, which involve placement of an elongate prosthesis in a helical configuration across the tissue structure site to be crossed, and confirmation that such helical suture configuration is positioned appropriately, before further interventional steps. A plug member may be included to assist with closure of the ports of defects. The elongate prosthesis and plug member may comprise bioresorbable materials.

METHOD AND APPARATUS FOR TRANSMYOCARDIAL REVASCULARIZATION USING A LASER

A surgical carbon dioxide laser is disclosed which includes a handpiece for directing a laser beam to a desired location. Mounted on the forward end of the handpiece is a hollow needle precisely aligned along the laser path. This permits the laser to be used in surgical applications where the needle perforates a portion of tissue to provide the laser beam direct access to distal tissue. The needle is mounted to the handpiece in a manner which provides for forward and lateral adjustment of the needle relative to the laser beam path which insures co-axiality between the laser beam and the needle lumen. This is crucial for the safe use of the laser. The needle is adjusted such that the focal point of the laser beam is approximately at the tip of the needle. This provides maximum energy at the tip of the needle where it is required. This apparatus is particularly useful in transmyocardial devices utilized to provide ischemic endocardial tissue direct access to blood within the ventricular cavity ...

METHOD AND APPARATUS FOR DELIVERY OF THERAPEUTIC AGENTS TO THE HEART

A method and system for delivering a therapeutic agent directly to the heart employing minimally invasive techniques and concepts. In particular. the delivery of vascular endothelial growth factors (VEGF) is performed endovascularly or endoxopically to a region of a patient's heart treated with transmyocardial revascularization (TMR). A system is provided for inducing cardioplegic arrest. An aortic occlusion device has an inflatable balloon which occludes the ascending aorta when inflated. Cardioplegic fluid may be infused through a lumen of the aortic occlusion device to stop the heart while the patient's circulatory system is supported on cardiopulmonary bypass_ A side-firing fiberoptic laser is introduced through the aortic occlusion device in the endovascular technique to perform TMR. Subsequently, a therapeutic agent delivery catheter is directed into one of the coronary arteries to deliver and dissipate the VEGF into the surrounding vascular plexus to promote angiogenesis stimulation ...

APPARATUS TO FACILITATE IMPLANTATION

A DEVICE A KIT FOR TREATMENT OF DISORDERS IN THE HEART RHYTHM REGULATION SYSTEM

A tissue cutting device is disclosed, which is structured and arranged to be inserted through thevascular system into a body vessel adjacent to the heart and/or into the heart, and to be subsequently subjected to a change of shape in order to penetrate into the heart tissue. The tissue cutting device may thus be used for treating disorders to the heart rhythm regulation system.A kit of devices provides a plurality of devices for creating a lesion pattern for treating such disorders.

METHODS AND SYSTEMS FOR ACCESSING THE PERICARDIAL SPACE

SYSTEM AND METHOD FOR CARDIAC DIALYSIS

A system and method for treating a patient may include implanting an apparatus that includes a tube housing a one-way valve and having first and second surfaces. When the apparatus is implanted, the first surface is located inside the right atrium of the patient and the second surface is located on the skin of the patient. When implanted, the apparatus is used for drawing blood from the right atrium and/or providing a liquid to the patient. The apparatus may be designed to be hermetically sealed when disconnected from input and output lines.

METHODS AND DEVICES FOR PUNCTURING TISSUE

DIRECTIONAL BALLOON TRANSSEPTAL INSERTION DEVICE FOR MEDICAL PROCEDURES

A transseptal insertion device suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum includes a sheath (12) that defines a lumen and has a distal end that is closest to the cardiac interatrial septum of a patient and a proximal end that is external to the patent, a balloon (14) that is connected to the distal end of the sheath (12), in which the balloon (14), when inflated, overhangs and extends past the distal end of the sheath (12), preventing accidental puncturing of the cardiac interatrial septum and stabilizing the transseptal insertion device against fossa ovalis of the cardiac interatrial septum, and a dilator (16) that is positioned within the at least one lumen. The dilator (16) has a distal end and is designed to and is capable of precisely puncturing the cardiac interatrial septum without the use of a needle or other sharp instrument.

SENSING SYSTEM FOR PERICARDIAL ACCESS

A surgical instrument includes an impedance sensing system for monitoring the position of the tip of the surgical instrument relative to the pericardial space. The surgical instrument consists of a guidewire or needle including a conductive core terminating at a distal tip of the guidewire or needle. The distal tip has a conductive surface exposed to patient tissues and/or fluids. The impedance sensing system includes a first electrode formed by the exposed surface of the guidewire or needle, and at least a second electrode isolated from the conductive core of the guidewire or needle. The second electrode may be formed on an outer surface of the guidewire or needle, or may be a pad electrode applied to the patient skin. The impedance sensing system also includes an impedance analyzer for measuring impedance and phase using one or more frequencies.

A FLOW REGULATING DEVICE IN THE HEART

A blood flow regulator (100) for creating a shunt in the heart, comprising; a proximal element (101) having a general disc-shape, defined by a braid of one or more wires extending about a central aperture (103) of the proximal element; a distal element (102) having a general disc-shape, defined by a braid of one or more wires extending about a central aperture (104) of the distal element; and a third element (105) defining a neck section intermediate the proximal and distal elements and forming a cavity (106) having a diameter no greater than a diameter of each of the distal and proximal elements, wherein said distal element comprises at least one loop (107) of a wire extending radially outwardly from a center (108) of the distal element and returning towards said center of said distal element.

METHODS AND APPARATUS FOR INTRODUCING CELLS AT A TISSUE SITE

The present invention relates to methods and devices for maintaining cellular viability and function for therapeutic purposes. The invention provides methods and devices for maintaining the proliferative and developmental potential of cellular preparations by protecting the from physical and physiological damage during storage, preparation, and delivery to a site (e.g., a tissue site). The invention also provides methods and devices for evaluating tissues and organs, and selecting appropriate sites for cellular delivery.

INJECTION ARRAY APPARATUS AND METHOD

A fluid delivery system for delivering and injecting fluid into heart tissue, or other organ tissues. The fluid delivery system includes an injection catheter disposed in an elongate sheath. A nozzle, including an injection array, is disposed adjacent the distal end of the injection catheter. In a first (microneedle) embodiment, the injection array comprises a plurality of microneedles each defining an injection lumen in fluid communication with the lumen of the catheter. In a second (needle-less) embodiment, the injection array comprises a plurality of injection lumens in fluid communication with the lumen of the catheter. Fluid is transferred to the injection lumen array from a fluid source through the lumen in the catheter. The injection lumen array distributes the fluid at the injection site over a greater area than would otherwise be achieved with a single needle injection. Thus, the injection lumen array improves fluid retention in the tissue at the injection site.

METHODS AND DEVICES FOR TREATING ATRIAL FIBRILLATION

Described here are systems and methods for affecting tissue within a body to form a lesion. Some systems comprise tissue-affecting devices, devices that guide the advancement of the tissue-affecting elements to a target tissue region, devices that locate and secure tissue, and devices that help position the tissue-affecting devices along the target tissue. The methods described here comprise advancing a first tissue-affecting device to a first surface of a target tissue, advancing a second tissue-affecting device to a second surface of the target tissue, and positioning the first and second devices so that a lesion may be formed in the tissue between them. In some variations, the devices, systems, and methods described here are used to treat atrial fibrillation by ablating fibrillating tissue from an endocardial surface and an epicardial surface of a heart. Methods of closing, occluding, and/or removing the left atrial appendage are also described.

Method and Apparatus for Advancing Catheters

A catheter comprises a catheter body (10) having a proximal end, a distal en d, and an electrode array disposed near he distal end (12). The electrode array includes a plurality of isolated electrode terminals (18). The electrode array and a common electrode (16) are connected to a high frequency power supply (32) an c9 the common electrode (16) may be located on the catheter, may be secured separately to a patient's skin, or may be formed as part of a movable guidewire. By contacting the electrode array against a target location in the patient's body, the target location may be selectively heated, with the current density being contacted at the points of contact between th e electrode terminals (18) and the tissue or stenotic material. For example, by positioning the common electrode within a stenotic region and contacting a leading surface of the stenotic region with the electrode array, the stenotic materi al can be heated by applying a high frequency voltage between the electrode array ...

ULTRASONIC AND INTERVENTIONAL CATHETER AND METHOD

... 2121353 9308738 PCTABS00021 A catheter (20) having a catheter body (22) with a proximal (24) and distal end (26). The catheter (20) including an ultrasonic transducer (30; 60) proximate its distal end (26). An access port (40) being provided in the catheter (20) for delivery of a therapeutic device (54; 56) or the like to proximate the distal end (26) of the catheter body (22). A guide wire port (42) being further provided for insertion therethrough of a guide wire.

ULTRASONIC AND INTERVENTIONAL CATHETER AND METHOD

A catheter (20) having a catheter body (22) with a proximal (24) and distal end (26). The catheter (20) including an ultra- sonic transducer (30; 60) proximate its distal end (26). An access port (40) being provided in the catheter (20) for delivery of a therapeutic device (54; 56) or the like to proximate the distal end (26) of the catheter body (22). A guide wire port (42) being fur- ther provided for insertion therethrough of a guide wire.

NEOVASCULARIZATION CATHETER

The present invention is a device and a method for boring a perfusion channel into the myocardial tissue of a patient. Structurally, the present invention includes a positioning catheter and a cutting catheter. The positioning catheter is formed with an inflation lumen and a deployment lumen and has an inflatable balloon mounted at its distal end. The cutting catheter has a sharpened distal end and is advanceable through the deployment lumen of the positioning catheter. Advancement of the cutting catheter through the deployment lumen causes the distal end of the cutting catheter to be directed radially outward from the positioning catheter. In use, the positioning catheter is positioned within a target vessel. The inflatable balloon is then expanded to anchor the distal end of the positioning catheter. The cutting catheter is then advanced through the deployment lumen, projecting the distal end of the cutting catheter radially outward from the positioning catheter, boring a perfusion channel ...

ANGLED BEAM DELIVERY HANDPIECE FOR LASER OR OTHER MONOCHROMATIC LIGHT SOURCE

An angled beam delivery handpiece (20) includes a barrel (22) for delivering a monochromatic light beam; a contact surface (24) at the distal end of the barrel (22); a window (32) in the side of the barrel (22) proximate the contact surface (24); an aperture (26) in the contact surface (22); and a refractive element in the barrel above the window (32) for diverting the beam carried by the barrel (22) to exit the aperture (26) at an angle to the laser beam in the barrel (22).

CONFORMAL CATHETER

This invention is an invasive probe apparatus including a flexible, elongate probe (20), having a distal end (22) for insertion into the body of a subject. The probe includes first and second position sensors (28, 30), fixed in a known relation to the distal end, which generates signals responsive to position coordinates thereof, and at least one contact sensor (70) along a radial surface thereof, which generates signals responsive to the contact of the radial surface with a surface inside the body. The apparatus further includes signal processing circuitry (36), which receives the position/responsive and contact/responsive signals, and processes them to determine the locations of a plurality of points along the length of a portion of the probe in a vicinity of the first and second position sensors.

METHOD AND ASSOCIATED DEVICE FOR REMOVING MATERIAL FROM BODY

This invention is a pull push device (10) for removing a clot. The device (10) includes an elongate tubular member (12) having a suction port (14) and an irrigation or fluid pressurization port (18) respectively connectable to a vacuum source (22) and a pressurized fluid reservoir. The tubular member also has a clot intake port (16) positionable through a patient's skin inside a clogged vascular vessel. The vacuum source (22) enables clot suction into the clot intake port (16) for severing while liquid pressure supplies fluid for clot ejection and device clearance. A single piece rotating or reciprocating cutter (28) and intake closure component (24) is mounted inside the tubular member for closing the clot intake port upon each small vacuum assisted severing of clot mass by the cutting element. By simultaneously severing the clot, and closing the intake port (16) by the closure component (24) the device automatically converts from a suction to a pressure mode, thus ejecting any clot through ...

PERCUTANEOUS ENDOMYOCARDIAL REVASCULARIZATION

This invention is a system and method for percutaneous myocardial revascularization using laser energy emitted from the distal end of a catheter. A technique for controlling beam direction allows the creation of channels in a patient's heart tissue with the channels having different orientations relative to the distal end. An arrangement provides for the creation of a plurality of channels at one time by simultaneous application of a plurality of beams of laser energy. A navigation arrangement uses two noncoplanar magnetic sensing coils (124F, 124T, 124S) in the distal end of the catheter cooperating with three sets of three magnetic field generating external coils (i.e., external to the patient) (120F1-120F3, 120S1-120S3, 120T1-120T3). Each of the three sets is sequentially energized and the sensing coils in the distal end sense the magnetic fields established. A computer compares the sensed fields with the known sequence of energizing the external coils and thereby determines the opposition ...

MONITORING OF MYOCARDIAL REVASCULARIZATION

This invention is an apparatus for PMR treatment, including an elongate probe (52) having a distal end (64) for engaging heart tissue (86) of a subject, and a revascularization device (60) which imparts energy to the heart tissue (86) for generating perfusion enhancing channels therein. A sensor (42) provides an indication responsive to the treatment, preferably by receiving signals generated by the body of the subject.

METHODS AND APPARATUS FOR MYOCARDIAL REVASCULARIZATION

An elongate probe for providing irradiation treatment of the heart, said probe having a distal end for engaging heart tissue of a subject, including a waveguide, which conveys radiation to the heart tissue; and a sensor, adjacent the distal end of the probe, which generates signals for use in controlling the treatment.

METHOD FOR VELOCITY COMPONENT VECTOR MAPPING

An elongate probe apparatus (20) for insertion into the body of a subject, comprising: a structure (24) having a substantially rigid configuration; a plurality of physiological sensors (26, 28, 30), which generate signals responsive to a physiological activity, said sensors (26, 28, 30)having substantially fixed positions on said structure (24) in said configuration; and one or more devices that generate position signals indicative of the positions of the physiological sensors on said structure in said configuration.

METHOD AND APPARATUS FOR ACCESSING THE PERICARDIAL SPACE

This invention is a pericardial centesis apparatus (100) and method for accessing the pericardial space. The invention consists of inserting a percutaneous tube (104) whose tip has a hole (123) which is positioned over and contacts the anterior pericardium. Introducing a vacuum within said tube (104) forms a pericardial bleb within that hole. A guided needle (124) within the tube is advanced to puncture the pericardial bleb while avoiding contact with the epicardium. A hollow filament or electro-cardial lead or flexible guide wire (114) within said needle can then be advanced into said pericardial cavity. The guide wire (114) may be used to guide an intra-pericardial catheter into the pericardial space for injection or infusion of selected therapeutic agents into the pericardial space to treat various heart and blood vessel diseases. Controlled drug release materials can be injected through said needle (124) for the slow and/or sustained delivery of said therapeutic agents into said pericardial ...

METHOD FOR TRANSVENOUSLY ACCESSING THE PERICARDIAL SPACE VIA THE RIGHT ATRIUM

A method for placing various types of catheters into the pericardial space takes advantage of the fact that the right auricle is a thin walled, lowpressure structure which can be readily penetrated without damaging the pericardium or the epicardium. A guide catheter (401) is passed through a selected peripheral vein to establish a trans-venous route to the right auricle of the heart. A needle catheter (401) is then passe through guide catheter and into the right auricle so that a distal end of the needle catheter (402) is positioned against a wall of the right auricle. The wall of the right auricle is than pierced with the needle catheter (402). A guide wire (403) is advanced through the needle catheter and into the pericardial space. Once in position the guide wire (403) can be used as a conduit over which a desired catheter may be introduced for performing a specific medical procedure.

INJECTION SYSTEM FOR GENE DELIVERY

An injection catheter is provided with a piezoelectric ultrasound emitting device at its distal end, capable of emitting ultrasound of differe nt energy levels. It can be used to image the location of penetration of an internal organ of a patient by the catheter needle, by supply of echocontrast materia l through the needle and analysis of the ultrasound reflections therefrom. It can also be used to cause tissue perturbation or disruption at the imaged location, e.g. to initiate tissue angiogenesis, by choice of suitable ultrasound energ y level of emission, and for delivery of therapeutic substances such as DNA to the disrupted tissue, for better uptake in gene therapy.

VIEWING SURGICAL SCOPE FOR MINIMALLY INVASIVE PROCEDURES

A viewing surgical scope apparatus is provided for minimally invasive surgical procedures such as transmyocardial revascularization (TMR) and capable of introducing a visualization scope and a working device such as an energy delivery device (e.g. an optical fiber). An elongated catheter has at least two working channels and a visualization device within the first working channel. A piercing needle having a lumen is within the second working channel and is translatable out of the distal end of the apparatus. A working device is provided in the lumen of the piercing needle and is translatable out of the distal end of the apparatus. An introducer assembly having an essentially rigid proximal portion and a flexible portion is coupled to the distal end of the catheter and a flexible cup member is coupled to the flexible distal portion of the introducer assembly.

DEVICE FOR INJECTIONS WITH MINIMUM GRIP AND ITS FIELD

EXPANDABLE MEDICAL DEVICE FOR TREATING CARDIAC ARRHYTHMIAS

L'invention concerne un dispositif médical expansible (10) comprenant une pluralité d'entretoises (14) de forme allongée, réunies entre elles de manière à former un dispositif sensiblement cylindrique (12) qui, sous la forme d'un cylindre d'un premier diamètre, peut se dilater en un cylindre d'un second diamètre. Au moins une desdites entretoises comporte au moins une ouverture (24, 26) s'étendant au moins partiellement à travers une épaisseur de ladite entretoise. Un agent utile est chargé en couches dans l'ouverture ménagée à l'intérieur de l'entretoise, ce qui permet d'obtenir la cinétique de libération temporelle souhaitée de l'agent. Cet agent utile peut être un agent d'ablation chimique utilisé pour créer une lésion de manière à traiter une fibrillation auriculaire. Une grande variété de profils de libération peut ainsi être obtenue, y compris des profils de libération d'ordre zéro, pulsatile, croissante, décroissante, sinusoïdale ou autres.

MICROCATHETER DEVICES AND METHODS FOR TARGETED SUBSTANCE DELIVERY

Delivery catheters useable to deliver substances, articles or devices to target locations within the bodies of human or animal subjects. The delivery catheter generally comprises a catheter having a tissue penetrating distal tip member on the distal end and one or more delivery aperture(s) whereby a substance, article or device may be delivered through the lumen of the catheter body and out of the delivery aperture(s). In some applications, the substance delivery catheter is used in combination with a transluminal tissue penetrating catheter having a penetrator that is advanced to a first location. The delivery catheter is then advanced through (or over) the penetrator, through intervening tissue, to a desired target location.

TRANSSEPTAL GUIDEWIRE

A transseptal guidewire and methods for perforating the intra-atrial septum of the heart are disclosed. The transseptal guidewire has an elongated body, an end section biased in a curved configuration to define a proximal curve, and a distal section biased in a curved configuration to defi ne a distal curve, the distal curve being oriented in a direction generally opposite that of the proximal curve.

Method and Apparatus for Delivering a Lead to a Heart

A method and apparatus for creating and accessing an anatomic space between a heart and a pericardial sac. The apparatus includes a catheter having a cryoadhesion member situated on the distal tip of the catheter. The cryoadhesion member is utilized to adhere to the pericardial sac and to retract the sac to create a tent like structure. The catheter allows introduction of an instrument to access the pericardial sac by puncture. The access to the pericardial sac allows delivery of a device, a drug, a biologic or other substance to the heart or the space around the heart.

Navigation System for Cardiac Therapies

An image guided navigation system for navigating a region of a subject includes an imaging device, a tracking device, a controller, and a display. The imaging device generates images of the region of the subject. The tracking device tracks the location of the instrument in the subject. The controller superimposes an icon representative of the instrument onto the images generated from the imaging device based upon the tracked location of the instrument. The display displays the image with the superimposed instrument.

Magnetic Ventricular Connector

A magnetic coupling for connecting a cannula to the apex of a ventricle comprising a first member having a first orifice, a first magnetic material attached to the first member, a means for attaching a cannula to the first member, a second member having a second orifice, a second magnetic material attached to the second member, a means for attaching the second member to a ventricle, so that when the first magnet is placed in proximity to the second magnet the first member and second member are held substantially concentric by magnetic force to allow for the communication of fluid between the first and second orifices.

Method and apparatus for performing transesophageal cardiovascular procedures

An apparatus for performing a transesophageal cardiovascular procedure includes an elongated tubular main access device having a first lumen with an open proximal end and a distal side opening, and a second lumen with a rigid outer wall and a collapsible inner wall. The second lumen is adapted to receive an elongated probe or surgical device. The apparatus further includes an inflatable sealing means on the outside of the main access device above and below the side opening, and a first fluid conduit extending along the main access device for inflating the sealing means so that when the main access device is inserted into a patient's esophagus and the sealing means are inflated. The portion of the esophagus opposite the side opening is isolated from the remainder of the esophagus above and below the side opening.

Systems and methods for navigating a surgical device

Systems and methods are disclosed for navigating a surgical device toward a target organ in the body of a patient. An example method includes providing a surgical needle and a guide wire, the surgical needle configured for insertion into a vein or a beating heart. The method also includes holding the guide wire within the surgical needle while the surgical needle is inserted into the vein or the beating heart. The method also includes generating output in two modes, the output based on at least one medical positioning system (MPS) sensor on the guide wire, the output corresponding to a position of the surgical needle and the guide wire for navigating the surgical needle and the guide wire toward a target in the vein or the heart. The methods can be carried out directly by a physician or via a computer processor-based surgical system.

Apical puncture access and closure system

A device, system, and method for providing access to, and sealing of, a body organ includes an implant device. An implant device has a main body having an internal access lumen, with a plurality of prongs extending from a distal end of the main body. The main body can include two lumens, one slidable within the other, to form a single continuous lumen with an adjustable length. The main body has an expanded configuration with an expanded diameter, and an unexpanded configuration with an unexpanded diameter. The prongs have a generally straight configuration where they extend distally of the distal end of the main body, and a bent configuration where the prongs bend around so that their tips extend proximally of the distal end of the main body. The device may include a hemostatic barrier to prevent fluid leakage therethrough when the main body is in the unexpanded configuration.

Apparatus and methods to create and maintain an intra-atrial pressure relief opening

The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

Apparatus and Method for Ablating Tissue

A control system alters one or more characteristics of an ablating element to ablate tissue. In one aspect, the control system delivers energy nearer to the surface of the tissue by changing the frequency or power. In another aspect, the ablating element delivers focused ultrasound which is focused in at least one dimension. The ablating device may also have a number of ablating elements with different characteristics such as focal length.

Methods and devices for diastolic assist

The devices and method described herein allow for therapeutic damage to increase volume in these hyperdynamic hearts to allow improved physiology and ventricular filling and to reduce diastolic filling pressure by making the ventricle less stiff.

Transapical valve replacement

Techniques for reaching the interior of the heart, such as for aortic valve replacement, can combine elements of percutaneous implantation methods and elements of surgical implantation methods. In some instances, aortic valve replacement may include a dual transapical approach in which a transfemoral approach is used to reach the apex of the patient's heart from inside the left ventricle while a minimally invasive surgical procedure provides access to the exterior of the apex via an intercostal approach.

Systems and methods for vacuum-assisted regeneration of damaged tissue

A system and method for regenerating damaged or necrosed tissue. Negative or vacuum pressure is applied to a surface of the damaged tissue to stimulate the revascularization of the area and/or increased blood flow to the area, which encourages the regeneration of the damaged tissue. A negative pressure device is provided that is capable of providing a sequenced vacuum treatment regimen to damaged tissue.

Method and apparatus for performing transesophageal cardiovascular procedures

An apparatus for performing a transesophageal cardiovascular procedure includes an elongated tubular main access device having a first lumen with an open proximal end and a distal side opening, and a second lumen with a rigid outer wall and a collapsible inner wall. The second lumen is adapted to receive an elongated probe or surgical device. The apparatus further includes an inflatable sealing means on the outside of the main access device above and below the side opening, and a first fluid conduit extending along the main access device for inflating the sealing means so that when the main access device is inserted into a patient's esophagus and the sealing means are inflated. The portion of the esophagus opposite the side opening is isolated from the remainder of the esophagus above and below the side opening.

Reflectance-facilitated ultrasound treatment and monitoring

Apparatus comprising an ultrasound ablation system ( 10 ), which comprises a reflection-facilitation element ( 12 ), configured to be placed at an extramyocardial site of a subject, and to provide an extramyocardial reflective region; and an ultra-sound tool ( 20 ), which comprises at least one ultrasound transducer ( 40 ) configured to be positioned within a heart chamber of the subject. The ultrasound transducer ( 40 ) is configured to ablate myocardial tissue by applying ultrasound energy to the myocardial tissue such that at least a portion of the transmitted energy is reflected by the reflective region onto the myocardial tissue. Other embodiments are also described.

Robotic catheter system

A robotic catheter system includes a controller with a master input device. An instrument driver is in communication with the controller and has a guide instrument interface including a plurality of guide instrument drive elements responsive to control signals generated, at least in part, by the master input device. An elongate guide instrument has a base, distal end, and a working lumen, wherein the guide instrument base is operatively coupled to the guide instrument interface. The guide instrument includes a plurality of guide instrument control elements operatively coupled to respective guide drive elements and secured to the distal end of the guide instrument. The guide instrument control elements are axially moveable relative to the guide instrument such that movement of the guide instrument distal end may be controlled by the master input device.

Apex closure device

Wound closure devices, systems, and methods may be used to close an opening, such as a puncture wound or incision, formed in tissue, such as heart tissue. A wound closure device may be configured and adapted to be placed within the puncture wound or incision to close and/or seal the puncture wound or incision. A bioadhesive may be used to strengthen the closure and/or seal of the puncture wound after placement of the wound closure device relative to the puncture wound.

Heart valve chordae replacement methods and apparatus

Apparatus for attaching a prosthetic tether between a leaflet of a patient's heart valve and another portion of the patient's heart to help prevent prolapse of the leaflet and/or to otherwise improve leaflet function. The apparatus can be used with relatively low invasiveness of the patient's body. The apparatus releasably clamps the leaflet during attachment of the tether to the leaflet. The apparatus may include an integrated display for indicating how extensively the leaflet is being clamped, as well as structure for stabilizing the leaflet for better clamping. The apparatus may enter the heart through an aperture in the wall of the heart, and may include structure for helping to reduce blood leakage from that aperture. The apparatus may be able to enter the heart by following a guide wire. The apparatus may include various means for attaching the tether to the leaflet.

Delivery devices, systems and methods for delivering therapeutic agents

Delivery devices, systems, and methods are configured to increase the retention of the therapeutic agent, and thereby increase the dose of the agent delivered. The delivery device may include a delivery body and a retractable member configured to move with respect to the delivery body. The retractable member may include a puncture member configured to create a delivery channel at the treatment site. The body may include an opening through which an agent may be delivered after the retractable member has been retracted within the device.

Endoscopic Cannulas and Methods of Using the Same

Endoscopic cannulas and methods of their use are disclosed. In some embodiments, an endoscopic cannula may include an elongated body having a proximal end and a distal end. A viewing channel and a working channel may extend through the elongated body. The viewing channel can be configured for passing therethrough an endoscope to the distal end of the elongated body for viewing outside the elongated body, while the working channel can be configured for passing therethrough an injection needle distally of the elongated body. The cannula may also include a suction pod disposed on a bottom surface of the elongated member, the suction pod being in communication with a suction channel extending through the elongated body to create suction between the suction pod and a tissue surface to temporary attach the elongated body to the tissue surface.

Method and System for Treatment of Biological Tissue

A composition for reconstruction, replacement or repair of damaged or diseased biological tissue comprising an extracellular matrix (ECM) composition that includes an ECM scaffold component derived from a mammalian source and at least one additional bioactive component selected from the group consisting of a statin and a chitin derivative.

System and method for transapical access and closure

Embodiments are described for creating and closing tissue access ports, such as transapical access ports, which involve placement of an introducer across the subject tissue structure, and deployment of a controllable port closure device assembly configured to remain in place with a ratcheting mechanism, and to hold the tissue surrounding the previous access port location closed against a sealing disc with proximal and distal strut assemblies, after the introducer has been removed.

FOSSA OVALIS PENETRATION USING PROBING ELEMENTS

A method is provided for puncturing a fossa ovalis of a heart, the method including inserting a catheter into a right atrium of the heart, and advancing a distal portion of the catheter toward an interatrial septum of the heart. A flexible longitudinal member is slid through openings disposed at the distal portion of the catheter, such that the flexible longitudinal member is made to loop around a portion of an inside perimeter of the fossa ovalis. While the flexible longitudinal member is looped around the portion of the inside perimeter of the fossa ovalis, a hole is punctured in the fossa ovalis at a puncturing point. 1106-. (canceled)107. A method for puncturing a fossa ovalis of a heart , the method comprising:inserting a catheter into a right atrium of the heart;advancing a distal portion of the catheter toward an interatrial septum of the heart;sliding a flexible longitudinal member through openings disposed at the distal portion of the catheter, such that the flexible longitudinal member is made to loop around a portion of an inside perimeter of the fossa ovalis; andwhile the flexible longitudinal member is looped around the portion of the inside perimeter of the fossa ovalis, puncturing a hole in the fossa ovalis at a puncturing point.108212-. (canceled)213. The method according to claim 107 , further comprising stabilizing the catheter by pressing the flexible longitudinal member against the portion of the perimeter of the fossa ovalis claim 107 , before puncturing the hole in the fossa ovalis.214. The method according to claim 107 , wherein sliding the flexible longitudinal member through the openings comprises sliding the flexible longitudinal member through the openings claim 107 , such that the flexible longitudinal member is made to loop around most of the inside perimeter of the fossa ovalis.215. The method according to claim 107 , wherein sliding the flexible longitudinal member through the openings comprises sliding exactly one flexible ...

STEERABLE ENDOLUMINAL PUNCH

A transseptal punch with a steering mechanism within the punch, such that punch can be steered and deflected within a guide catheter during delivery, to avoid skiving of the guide catheter inner wall by passage of the punch tip through the guide catheter. The punch can be advanced through a body lumen in its straight configuration and then be selectively articulated or curved to permit negotiation of tortuous curvature or to permit optimal approach or access to a puncture site. The punch is able to create holes in the atrial septum of the heart or other structures and is easier to use than punches that are pre-curved near their distal tip since it is easier to advance through accessory catheters. 1. A transseptal punch system for penetrating the atrial septum of a patient , said system comprising:a guide catheter adapted for insertion into the right atrium of a patient's heart, said guide catheter characterized by a distal end, and proximal end, and a guide catheter lumen extending from the distal end to the proximal end; an outer tube, said outer tube characterized by a distal end and a proximal end, and an outer tube lumen extending from the distal end to the proximal end thereof, said outer tube having a flexible region near the distal end of the outer tube;', 'a control rod disposed within the outer tube, said control characterized by a distal end and a proximal end;', 'wherein the control rod is fixed to the distal end of the outer tube; and, 'a transseptal punch, said transseptal punch having a distal end and a proximal end, said transseptal punch fitting within the guide catheter lumen and being longitudinally advanceable within the guide catheter, said punch comprisingan inner tube fixed to the distal end of the outer tube, said inner tube having a sharp point for penetrating the atrial septum of the patient.2. The system of wherein:the control rod is fixed to the distal end of the outer tube, at a point distal to the flexible region.3. The system of wherein ...

Devices and methods for closure of transvascular or transcameral access ports

The present disclosure provides a variety of prostheses, delivery systems and techniques to facilitate closure of transvascular or transcameral access ports. Various embodiments of prostheses are provided including a plurality of radially expandable discs that can be filled with material to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.

Medical device and treatment method

A medical device and a treatment method, in which energy is accurately applied to a target site by suppressing a positional displacement between an expansion body and a biological tissue. The medical device includes an elongated shaft portion and an expansion body disposed in a distal portion of the shaft portion and configured to expand and contract in a radial direction. The expansion body includes a holding portion having a proximal side holding portion and a distal side holding portion configured to hold the biological tissue, and a movable portion configured to open and close the holding portion.

DEVICES AND METHODS OF VISUALIZING AND DETERMINING DEPTH OF PENETRATION IN CARDIAC TISSUE

Disclosed herein are devices and methods for assessing the surface of a target cardiac tissue and for delivering a tissue anchor to cardiac tissue at a preselected depth within the myocardium in a beating heart procedure. In one variation, an anchor delivery device comprises an elongate body, a tissue anchor disposed within a first longitudinal lumen of the elongate body, and a tissue depth indicator slidable within a second longitudinal lumen of the elongate body. The tissue depth indicator has a first configuration that indicates the boundary of the surface of the target tissue and a second configuration that indicates when the distal tip of the elongate body has been advanced to a preselected depth into the target tissue. In some variations, a tissue depth indicator may also be configured to resist or limit the penetration of the delivery device into tissue after a preselected depth has been reached. 1: A tissue anchor delivery device comprising:an elongate body comprising a proximal end, a distal end, a first distal opening located at the distal end of the elongate body, and a second distal opening located proximal to the distal end of the elongate body, wherein a longitudinal distance between the first distal opening and the second distal opening corresponds to a pre-selected tissue anchor delivery depth;a tissue depth indicator comprising a radiopaque indicator wire having a proximal portion and a distal portion that is extendable from the second distal opening and is more compliant than the proximal portion, wherein the tissue depth indicator comprises a first configuration wherein the distal portion of the radiopaque indicator wire extends toward the distal end of the elongate body and a second configuration wherein the distal portion of the radiopaque indicator wire extends away from the distal end of the elongate body, and wherein the tissue depth indicator is configured to transition from the first configuration to the second configuration after the ...

System(s), method(s) and device(s) for the prevention of esophageal fistula during catheter ablation

The present invention is directed to systems, devices and methods for trans-septally delivering carbon dioxide through a minimally invasive catheter to create a gaseous pocket or emphysema between the posterior wall of the left atrium and the esophagus during cardiac ablation of the left atrium. This pocket of gas expanded tissue serves to thermally insulate and separate the esophagus from the left atrium during ablation to prevent the formation of an atrial-esophageal fistula. The system comprises a control system to precisely deliver the gas to a desired location through a needle-based catheter assembly.

STEERABLE ENDOLUMINAL PUNCH

An endoluminal needle or punch is describes wherein the distal end of the endoluminal needle is able to articulate laterally out of the longitudinal axis of the steerable endoluminal needle. The endoluminal needle further comprise a blunted distal end configuration that is minimally traumatic. Under control by the user, at the proximal end of the endoluminal needle, a sharp stylet can be advanced to punch tissue and then be retracted to maximize safety. The endoluminal needle is configured for use within an introducer. 1. A device for penetrating a body lumen or hollow organ of a mammal comprising:an outer tube, said outer tube characterized by a distal end, and proximal end, and an outer tube lumen extending from the distal end to the proximal end thereof, said outer tube having a flexible region near the distal end of the outer tube;a first control rod disposed within the outer tube, said first control characterized by a distal end and a proximal end, said first control rod comprising a partial cylinder, wherein the control rod is longitudinally fixed to the distal end of the outer tube and extends proximally to the proximal end of the outer tube; anda hub disposed at the proximal end of the outer tube, said hub operable to pull the proximal end of the first control rod to exert compression force on the outer tube and thereby cause deflection of the flexible region relative to the less flexible regions of the outer tube proximal to the flexible region.2. The device of claim 1 , further comprising:a second control rod disposed within the outer tube, said second control rod characterized by a distal end and a proximal end, said first control rod comprising a partial cylinder, wherein the second control rod is longitudinally fixed to the distal end of the outer tube and extends proximally to the proximal end of the outer tube; whereinthe hub further is further operable to tension the proximal end of the second control rod to cause deflection of the flexible region ...

Electrosurgical Pericaridial Puncture

Devices and methods for providing access to the pericardial cavity while reducing risk of myocardial damage. One method includes using an apparatus to apply pressure to a parietal pericardium, retracting the apparatus, and puncturing the parietal pericardium by delivering electrical energy using a puncture device. Another method includes moving a portion of parietal pericardium away from a surface of myocardium of the heart and puncturing the parietal pericardium by delivering electrical energy using a puncture device. The methods may include a step of confirming that the puncture device is at least partially within the parietal cavity by injecting or aspirating fluid through a lumen in the puncture device or measuring the pressure or electrical impedance at the distal end of the puncture device. 121.-. (canceled)22. A method of accessing a pericardial cavity of a heart comprising:a. using an apparatus to apply pressure to a parietal pericardium;b. retracting the apparatus; andc. puncturing the parietal pericardium by delivering electrical energy using a puncture device.23. The method of claim 22 , further comprising the step of advancing the puncture device through the apparatus.24. The method of claim 22 , further comprising a step of confirming that the puncture device is at least partially within the pericardial cavity.25. The method of claim 24 , wherein the step of confirming that the puncture device is at least partially within the pericardial cavity comprises injecting a contrast fluid into the pericardial cavity through a lumen of the puncture device.26. The method of claim 24 , wherein the step of confirming that the puncture device is at least partially within the pericardial cavity comprises aspirating fluid from the pericardial cavity through a lumen of the puncture device.27. The method of claim 24 , wherein the step of confirming that the puncture device is at least partially within the pericardial cavity comprises measuring electrical impedance at a ...

IMAGE-GUIDED TRANSSEPTAL PUNCTURE DEVICE

Provided herein is a catheter assembly including an imaging device for identifying an anatomical structure. The catheter assembly includes a patient cannula configured to be drawn along a catheter or guide wire; a transseptal puncture catheter at least partially enclosed within the patient cannula; and an imaging catheter. The imaging catheter includes a transducer configured to emit an energy beam capable of reflecting from an anatomical structure and to detect energy reflected from the structure. The catheter assembly also includes a transmitter for conveying a signal representative of the detected energy from the transducer to a signal processor for obtaining information about the structure. An imagining system and a method for identifying a predetermined transseptal puncture location on an atrial septum are also provided herein. 1. A catheter assembly for performing a puncture of an anatomical wall , the catheter assembly comprising:a patient cannula configured to be drawn along a catheter or guide wire;a puncture catheter at least partially enclosed within the patient cannula;an imaging catheter comprising at least one transducer located on a distal portion of the imaging catheter configured to emit an energy beam in an axial direction, the energy beam being capable of reflecting from a portion of the anatomical wall and to detect energy reflected from the anatomical wall; anda transmitter for conveying a signal representative of the detected energy from the transducer to a signal processor for obtaining information for visually distinguishing thickness of different portions of the anatomical wall.2. The catheter assembly of claim 1 , wherein the puncture catheter comprises an introducer and a transseptal needle.3. The catheter assembly of claim 1 , wherein the imaging catheter is enclosed within claim 1 , co-formed claim 1 , or integrated with the patient cannula.4. The catheter assembly of claim 1 , wherein the imaging catheter extends parallel with and is ...

Transcatheter insertion device and method

The present invention relates to a transcatheter method for providing fluid communication between two anatomical compartments. The present invention also relates to a transcatheter system comprising an intracorporeal connector for fluid communication between two anatomical compartments through at least one anatomical wall, wherein said connector is adapted to receive a flow regulating device, a connector, a flow regulating device and an insertion device.

PERICARDIAL MODIFICATION SYSTEMS AND METHODS FOR HEART FAILURE TREATMENT

This document relates to devices and methods for the treatment of heart conditions. For example, this document relates to devices and methods for treating heart failure with preserved ejection fraction, including diastolic heart failure, by performing a pericardial modification procedure.

Transcatheter atrial anchors and methods of implantation

Anchor assemblies for endovascular introduction and implantation for tethering a replacement heart valve to a cardiac wall. An anchor delivery system introduces the assembly. The anchor may be either implanted with a tether connected thereto or implanted and then connected to a tether. If the latter, a tether assembly is mounted to the implanted anchor to connect the anchor to the valve. The anchors may be implanted into any cardiac wall including the interventricular septum or the epicardial space and the valve may replace the mitral or tricuspid valve.

TRANSCATHETER SYSTEM AND METHOD FOR REGULATING FLOW OF FLUID BETWEEN TWO ANATOMICAL COMPARTMENTS

The present invention relates to a transcatheter method for providing fluid communication between two anatomical compartments. The present invention also relates to a transcatheter system comprising an intracorporeal connector for fluid communication between two anatomical compartments through at least one anatomical wall, wherein said connector is adapted to receive a flow regulating device, a connector, a flow regulating device and an insertion device. 1. A transcatheter system comprising an intracorporeal flow regulating device for regulating the flow of fluid between two anatomical compartments through at least one anatomical wall , wherein the flow regulating device comprises means for intracorporeally securing the flow regulating device to an connector intracorporeal connector positioned through said anatomical wall(s).2. The system according to claim 1 , wherein the flow regulating device comprises an actuator to allow or prevent fluid flow through the intracorporeal connector.3. The system according to claim 1 , wherein the flow regulating device comprises a first portion located in use in the first compartment claim 1 , a second portion located in use in the second compartment claim 1 , and an intermediate portion located in use through the anatomical wall(s).4. The system according to claim 3 , wherein the first portion and/or the second portion comprises one or more apertures for fluid passage from the first compartment to the second compartment.5. The system according to claim 3 , wherein the first portion comprises a cross-section of larger diameter than the diameter of the cross-section of the intermediate portion.6. The system according to claim 1 , wherein when the flow regulating device is coupled to the connector claim 1 , fluid can flow from the first compartment to the second compartment claim 1 , and when the flow regulating device is not coupled to the connector claim 1 , fluid is prevented from flowing from the first compartment to the second ...

Catheter having tissue-engaging device

An elongated catheter includes a tissue-engaging device configured to be urged to move and contact a first surface of the first biological wall. The tissue-engaging device extends from the distal catheter section. The tissue-engaging device is configured to be urged to puncture through the first biological wall. The tissue-engaging device is also configured to be urged to contact the first biological wall without impinging the second biological wall, after the tissue-engaging device has punctured through the first biological wall.

APPARATUSES AND METHODS FOR CUTTING A TISSUE BRIDGE AND/OR REMOVING A HEART VALVE CLIP OR SUTURE

Disclosed is an instrument having an elongated shaft, a first member configured in the elongated shaft such that the first member can be deployed from a first portion of the instrument. The first member, when deployed, is configured over a tissue bridge within a heart, the tissue bridge having a clip or suture. A second member is also configured in the elongated shaft such that the second member is deployed from a second portion of the elongated shaft, wherein the second member, when deployed, is configured under the tissue bridge and the clip or suture. The elongated shaft is configured such that the second member, when deployed, moves towards the first member to yield a combined member which receives the tissue bridge and the clip or suture. The elongated shaft receives the combined member. The first member and/or the second member include a signal emitter to cut the tissue bridge. 1. A method comprising:inserting an instrument into a valve orifice within a human heart;deploying a first member from a first portion of the instrument, wherein the first member is configured over a tissue bridge having an associated clip or suture;deploying a second member from a second portion of the instrument, wherein the second member is configured below the tissue bridge having the associated clip or suture;moving the second member towards the first member, to yield a combined member such that the tissue bridge is cut and the combined member contains the associated clip or suture;folding the combined member into the instrument; andretrieving the instrument from the valve orifice.2. The method of claim 1 , wherein cutting the tissue bridge occurs via an interaction between edges of the first member and the second member.3. The method of claim 1 , wherein cutting the tissue bridge occurs via an electromagnetic signal emitted from one of the first member or the second member.4. The method of claim 1 , wherein the combine member comprises a cylindrical shaped member containing the ...

APPARATUS AND METHODS FOR CUTTING AN ATRIAL WALL

A method includes coupling, at least temporarily, a support member adjacent to a target tissue. The support member is configured to support the target tissue and to define a path along which a cutting device can move. The method includes moving the cutting device along the path defined by the support member to cut and/or dilate the target tissue. In some embodiments, the method optionally includes disposing a cannula of a device within the cut defined in target tissue. The cannula is coupled to the target tissue such that a lumen defined by the cannula is in fluid communication with a volume defined at least in part by the target tissue. 1. A method for cutting a tissue wall comprising:inserting a support member including a contact portion into a first opening in an organ wall;moving the support member beyond the organ wall to transition the contact portion from a linear configuration to a non-linear configuration; andretracting the support member toward the organ wall to position the contact portion proximate a surface of the organ wall.2. The method according to claim 1 , further comprising piercing the organ wall from a first side of the organ wall to a second side of the organ wall to form a second opening in the organ wall claim 1 , the second opening larger than the first opening.3. The method according to claim 1 , wherein the non-linear configuration includes the contact portion formed as an annular ring.4. The method according to claim 1 , further comprising applying a cutting force to the organ wall when the contact portion is proximate the surface of the organ wall.5. The method according to claim 1 , wherein the support member includes a guide portion claim 1 , and the contact portion surrounds the guide portion when the contact portion is in the non-linear configuration.6. The method according to claim 1 , wherein the organ wall is an atrial wall.7. A method for cutting an atrial wall comprising:coupling a support member to a vacuum source, the support ...

METHOD AND CATHETER FOR CREATING AN INTERATRIAL APERTURE

A catheter device with a cutting structure or means on the distal portion is disclosed, along with a medical procedure for using the device. The catheter is configured in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue. 1. A medical device assembly comprising: an elongated sheath shaft, the sheath shaft having a first bend region, a central lumen and a distal end,', 'a first steering wire, the steering wire having a first position and a second position, wherein at the first position the first bend region is substantially linear, and wherein at the second position the distal end of the sheath is substantially perpendicular to a longitudinal axis of the sheath,, 'a sheath, the sheath comprising 'a catheter shaft, the catheter shaft having a central lumen,', 'a catheter inside the sheath, the catheter comprising 'a blade cutting edge that is oriented at a substantially right angle to the longitudinal axis of the sheath when the sheath is oriented substantially perpendicular to the inter atrial septum, and is adapted to cut a 3 mm or larger durable aperture in the interatrial septum,', 'a shaped blade, the shaped blade comprisinga tissue articulator adapted to hold the interatrial septum.2. The assembly of further comprising a marker to identify the catheter location on a visualization system.3. The assembly of claim 1 , wherein the articulator is a suction device.4. The assembly of claim 3 , wherein the assembly does not comprise a component adapted to cross the interatrial septum such as a guidewire or needle.5. The assembly of claim 3 , wherein the articulator is adapted to retain the interatrial septum from only the same side of the interatrial septum as the shaped blade cuts the interatrial septum.6. The assembly of wherein the shaped blade is selected from the group consisting of a circular blade claim 1 , a square blade claim 1 , a triangular blade claim 1 , a sawtoothed ...

DIRECTIONAL BALLOON TRANSSEPTAL INSERTION DEVICE FOR MEDICAL PROCEDURES

A transseptal insertion device suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum includes a sheath that defines a lumen and has a distal end that is closest to the cardiac interatrial septum of a patient and a proximal end that is external to the patent, a balloon that is connected to the distal end of the sheath, in which the balloon, when inflated, overhangs and extends past the distal end of the sheath, preventing accidental puncturing of the cardiac interatrial septum and stabilizing the transseptal insertion device against fossa ovalis of the cardiac interatrial septum, and a dilator that is positioned within the at least one lumen. The dilator has a distal end and is designed to and is capable of precisely puncturing the cardiac interatrial septum without the use of a needle or other sharp instrument. 1. A transseptal insertion device which is suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum , comprising:a sheath that defines at least one lumen therein and has a distal end that is closest to the cardiac interatrial septum of a patient when the transseptal insertion device is in use and a proximal end that is external to the patent;a balloon that is connected to the distal end of the sheath, wherein the balloon, when inflated and the transseptal insertion device is in use, overhangs and extends past the distal end of the sheath, preventing accidental puncturing of the cardiac interatrial septum and stabilizing the transseptal insertion device against fossa ovalis of the cardiac interatrial septum; anda dilator that is positioned within the at least one lumen when the transseptal insertion device is in use, wherein the dilator has a distal end and is designed to and is capable of precisely puncturing the cardiac interatrial septum without the use of a needle or other sharp instrument.2. The transseptal insertion device of wherein the balloon portion that overhangs and ...

Directional balloon transseptal insertion device for medical procedures

A transseptal insertion device suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum includes a sheath that defines a lumen and has a distal end that is closest to the cardiac interatrial septum of a patient and a proximal end that is external to the patent, a balloon that is connected to the distal end of the sheath, in which the balloon, when inflated, overhangs and extends past the distal end of the sheath, preventing accidental puncturing of the cardiac interatrial septum and stabilizing the transseptal insertion device against fossa ovalis of the cardiac interatrial septum, and a dilator that is positioned within the at least one lumen. The dilator has a distal end and is designed to and is capable of precisely puncturing the cardiac interatrial septum without the use of a needle or other sharp instrument.

METHOD FOR REPLACEMENT OF HEART VALVE

A method for implanting a replacement heart valve within a diseased valve includes accessing a patient's heart by piercing a myocardium, advancing a guidewire into the patient's heart, and installing an access device in a wall of the heart. The access device preferably has at least one valve mechanism. A valve delivery device is advanced over the guidewire and through the access device. The valve delivery device has a replacement heart valve disposed along a distal end portion thereof. The replacement heart valve preferably includes an outer support structure and a leaflet valve disposed within the outer support structure. The replacement heart valve is radially expanded within the diseased valve. During implantation, the outer support structure conforms to a diameter of the diseased valve and the leaflet valve expands to a fixed size having a diameter smaller than the diameter of the diseased valve. 1. A method for implanting a replacement heart valve within a diseased valve , the method comprising:accessing a patient's heart by piercing a myocardium;advancing a guidewire into the patient's heart;installing an access device in a wall of the heart, the access device having at least one valve mechanism for preventing blood from escaping the patient's heart;advancing a valve delivery device over the guidewire and through the access device, the valve delivery device having a replacement heart valve disposed along a distal end portion thereof, the replacement heart valve including an outer support structure and a leaflet valve disposed within the outer support structure; andradially expanding the replacement heart valve in the diseased valve;wherein the outer support structure conforms to a diameter of the diseased valve and the leaflet valve expands to a fixed size with a diameter smaller than the diameter of the diseased valve.2. The method of claim 1 , wherein the leaflet valve comprises leaflets made from pericardium.3. The method of claim 2 , wherein the outer ...

Engagement catheter devices, systems, and methods to use the same under suctional tissue engagement

Engagement catheter devices, systems, and methods to use the same under suctional tissue engagement. A method of the present disclosure comprises the steps of engaging a targeted tissue under suction/vacuum using an engagement catheter, delivering a substance into or through the targeted tissue using a needle positioned within a first lumen of the engagement catheter, injecting a fluid within the first lumen of the engagement catheter to flush at least part of the first lumen with the fluid, and suctionally removing the injected fluid from within the first lumen of the engagement catheter.

Minimally invasive methods and apparatus

Methods and apparatus are provided to facilitate the minimally invasive removal of tissue biopsies and to facilitate the direct approach to anesthetizing the chest wall, in accordance with embodiments of the present invention. A pull-type cutting device 1 comprises two coaxially nested tubes, each extending from a proximal end 21 to a distal end 22 . The first tube 61 defines a guide wire lumen 23 for slidingly receiving a guide wire. The second tube 63 extends over the first tube 60 and coupled thereto at the distal end 22 defining an expandable portion 13 adjacent the distal end 22 . The second tube 63 defines an inflation lumen 25 extending from the shaft proximal end 21 to the expandable portion 13 . The inflation lumen 25 communicates inflation fluid from the proximal end 21 to the expandable portion 13 so as to inflate and deploy the expandable portion 13 . Disposed adjacent the shaft distal end 22 is a cutting head 10 comprising the expandable portion 13 having a cutting portion 11 distal from the shaft distal end 22.

METHOD FOR POSITIONING TERMINAL END OF PACEMAKER LEAD, WHICH HAS PASSED THROUGH CORONARY SINUS, IN INTERVENTRICULAR SEPTUM

The present invention relates to a method for positioning a tip of a pacemaker lead that has passed through coronary sinus into an interventricular septum. More particularly, it relates to a method for positioning a tip of a pacemaker lead that has passed through a coronary sinus into an interventricular septum in order to more effectively transmit an electrical stimulus in a treatment using a pacemaker for patients with arrhythmia. 170-. (canceled)71. A method of positioning a distal portion of a pacemaker lead , the method comprising:a step of positioning an intervention wire through a proximal septal vein a step of inserting a safe zone catheter inserted in an inferior vena cava into the right ventricle through a right atrium and a safe zone of a tricuspid valve;a step of inserting a guide wire through the safe zone catheter;a step of pulling out the safe zone catheter toward the inferior vena cava with the guide wire maintained in the right ventricle of the heart;a step of capturing the intervention wire with a capture catheter inserted along the guide wire;a step of pulling out the intervention wire captured by the capture catheter toward the inferior vena cava by pulling out the capture catheter toward the inferior vena cava with the guide wire maintained in the right ventricle of the heart; anda step of holding both ends of the intervention wire and positioning the distal portion of the lead into the interventricular septum by inserting the pacemaker lead along the intervention wire.72. The method of claim 71 , wherein the step of positioning an intervention wire includes a step of finding a proximal septal vein positioned in the interventricular septum by inflating a balloon at a front end of a balloon-tipped guiding catheter to block and contrast the coronary sinus by injecting air into the balloon from the outside.73. The method of claim 71 , wherein the step of positioning an intervention wire includes a step of boring that uses an interventricular septum ...

Electrosurgical Pericardial Puncture

Devices and methods for providing access to the pericardial cavity while reducing risk of myocardial damage. One method includes advancing a distal end of a puncture device towards the heart from a subxiphoid region of a patient wherein the distal end of the puncture device is atraumatic and comprises an energy delivery device; positioning the energy delivery device at a target site on a pericardium of the heart using ultrasound for imaging; and delivering energy from the energy delivery device to a tissue of the target site to create a channel to the pericardial cavity. The method may include repeating one or more of the above steps until the energy delivery device is located within the pericardial cavity. Some embodiments of the method include using supplemental means of monitoring, including medical imaging and using contrast fluid.

Cardiac tissue anchoring devices, methods, and systems for treatment of congestive heart failure and other conditions

A heart tissue gripping device may include a body portion, an elongate shaft, and a tissue gripping member that is attached to the distal end of the elongate shaft. The tissue gripping member being may be positioned adjacent a heart surface by insertion through an incision in the body. The tissue gripping member may releasably attach to tissue of the heart surface to facilitate a surgical instrument in performing one or more procedures. A coupling of the tissue gripping member may releasably attach the surgical device to the tissue gripping member to allow the device to access the tissue of the heart surface.

TRANSSEPTAL GUIDE WIRE PUNCTURE SYSTEM

A trans-atrial septal catheter system for delivery of a steerable sheath into the left atrium contains three components. The first component is a three-segmented needle-guide wire composed of a distal needle designed to flex sharply in relation to the conjoined looped guide wire segment after fossa ovalis puncture and needle advancement. The distal guide wire loops are advanced into the left atrium maintaining the angled needle in a central location relevant to the loops for preserving an atraumatic position while stabilizing the loops in the left atrium. The elongated proximal extra stiff guide wire segment is conjoined to the looped segment which crosses the fossa ovalis and extends proximally to become externalized to the femoral vein. This segment is extra stiff and significantly elongated to permit catheter and device exchanges. The guide wire serves as a support rail over which the dilator and sheath can be advanced into the left atrium. This transseptal system is uniquely forward looking and permits cautious and iterative delivery of the dilator into the fossa ovalis for “tenting” by way of a proximal sheath activator that interacts with the dilator. The proximal externalized GW is then advanced to permit puncture of the fossa ovalis. After puncturing a precise location of the fossa ovalis, the needle and coiled guide wire loops are further advanced into the left atrium. With the proximal activator, the dilator is advanced across the fossa ovalis into the left atrium using single-handed maneuvering for separate dilator advancement and steering of the sheath by way of turning or actuating the sheath handle. 1. A transseptal guide wire , comprising a proximal end , a distal end and a middle segment ,a. wherein the proximal end is in continuity with the middle segment via a proximal guide wire segment;b. wherein the proximal guide wire segment is stiff and further comprises a distal segment and a proximal segment connected by a secondary bend in achieving a more ...

METHODS AND SYSTEMS FOR ACCESSING A PERICARDIAL SPACE AND PREVENTING STROKES ARISING FROM THE LEFT ATRIAL APPENDAGE

The invention presents methods and systems for accessing a pericardial space and preventing strokes arising from a left atrial appendage (“LAA”) by achieving a complete occlusion of the LAA using an epicardial approach without creating a puckering of the LAA ostium. A complete occlusion of the LAA is desired because bleeding arising from the LAA often leads to embolic strokes. Due to the peculiar anatomy of the LAA ostium, traditional LAA ligation techniques using sutures can lead to puckering, thus compromising the occlusion of the LAA. The invention achieves a complete occlusion and a more effective hemostatic seal with the use of inflatable balloons having electromagnetic coils internally, as well as hydrogels, sponges, and caliber tubes attached to the respective balloon's exterior, anchoring balloons, a closure device having a suture looped through two semi-rigid hollow tube that can be coated with hydrogel or silicone, and locking mechanisms. 1. A method for accessing a pericardial cavity and preventing strokes arising from a left atrial appendage (LAA) , said method comprising:introducing a catheter into a body cavity, wherein the catheter comprises an inner sheath, an outer sheath, and an inner catheter;advancing a distal end of the inner sheath to position the distal end of the inner sheath in an interior of the LAA;inflating a first inflatable balloon, wherein the first inflatable balloon is on the distal end of the inner sheath, wherein the first inflatable balloon is non-compliant, and wherein the first balloon is inflated within the LAA interior adjacent to an ostium of the LAA;pulling the inflated first balloon in a direction from within the LAA interior and towards the LAA ostium;inflating a second inflatable balloon, wherein the second balloon is on the distal end of the inner sheath, wherein the second balloon is inflated within a distal portion of the LAA interior, and wherein upon inflation, the inflated second balloon pushes the inflated first ...

Methods and Devices for Puncturing Tissue

A method and system are disclosed for puncturing tissue, comprising a puncture device for puncturing tissue and a supporting member for supporting the puncture device. The puncture device is capable of being insertable within the supporting member and being selectively usable in co-operation therewith during a portion of a procedure for puncturing tissue and wherein the puncture device is usable independently therefrom during another portion of the procedure. 1. A needle assembly for puncturing tissue and enhancing procedural efficiency by facilitating exchange and positioning , the needle assembly comprising:a puncture device for puncturing tissue; anda supporting member for supporting the puncture device:wherein the puncture device is capable of being insertable within the supporting member and being selectively usable in co-operation therewith during a portion of a procedure for puncturing tissue and wherein the puncture device is usable independently therefrom during another portion of the procedure.2. The needle assembly of claim 1 , wherein the puncture device comprises a substantially flexible puncture device.3. The needle assembly of claim 1 , wherein the puncture device comprises a substantially atraumatic distal tip claim 1 , wherein the puncture device is substantially atraumatic.4. The needle assembly of claim 1 , wherein the puncture device comprises an energy based puncture device.5. The needle assembly of claim 1 , wherein the puncture device comprises a mechanical puncture device.6. The needle assembly of claim 2 , wherein the puncture device comprises a substantially atraumatic distal tip claim 2 , wherein the puncture device is substantially atraumatic.7. The needle assembly of claim 6 , wherein the puncture device comprises an energy based puncture device.8. The needle assembly of claim 7 , wherein the puncture device comprises a flexible RF guidewire.9. The needle assembly of claim 1 , wherein the supporting member comprises a needle shaft ...

METHOD AND CATHETER FOR CREATING AN INTERATRIAL APERTURE

A catheter device with a cutting structure or means on the distal portion is disclosed, along with a medical procedure for using the device. The catheter is utilized in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue. 1. A method of treating congestive heart failure comprising the steps of: a shaft,', 'a shaped cutting blade arranged around a distal catheter portion,', 'a tissue articulator, the tissue articulator having a first position and a second position,', 'an actuator connected to the tissue articulator, 'inserting a catheter into the right atrium of the heart, the catheter comprisingcrossing the interatrial septum,actuating the actuator to move the tissue articulator into a second position that holds the tissue for the shaped cutting blade,cutting an aperture in the interatrial septum between the right atrium and the left atrium,removing a cut tissue from the right atrium.2. The method of further comprising a step of attaching a tissue removal device to the interatrial septum.3. The method of claim 2 , further comprising the step of actuating the tissue removal device to remove the cut tissue.4. The method of claim 3 , wherein the tissue removal device comprises a hook claim 3 , a balloon claim 3 , a disk claim 3 , or an expandable basket.5. The method of claim 4 , further comprising the step of tenting the tissue using the tissue removal device to pull claim 4 , grasp claim 4 , or push the tissue into a catheter lumen or the shaped blade before it is cut.6. The method of claim 2 , wherein the tissue removal device comprises a proximal portion and a distal portion claim 2 , and further comprising the step of actuating the tissue removal device.7. The method of claim 6 , wherein the step of actuating the tissue removal device reduces the distance between the proximal portion and distal portion of the tissue removal device.8. The method of claim 7 , wherein actuating ...

TRANSSEPTAL ACCESS DEVICE AND METHOD OF USE

Systems, devices, and methods are provided for transseptal access of septa within a patient. The device can be advanced to a septum, e.g., towards a fossa ovalis. Instead of applying positive pressure to “tent” the septum, a negative pressure is applied to a lumen within a sheath, e.g., within an elongated member slidable within the sheath, via a negative pressure source such as a syringe on the proximal end of the sheath. This results in the septum pulling inward. The sheath employs a stationary needle-like central core component contained within the lumen of the sheath that punctures the septum when the same is pulled passed it by the negative pressure. The stationary needle-like central core component may be hollow and may form a portion of the elongated member or may be coupled to a distal end thereof. 1. A method of gaining access through a septum or other tissue comprising:a. delivering a device to a selected location at a septum or other tissue, the device including a funnel with a proximal end and a distal end and an interior therebetween, the distal end having a greater radius than the proximal end;b. placing the distal end of the funnel against the selected location;c. drawing a negative pressure in the interior, such that a portion of the septum or other tissue and selected location are pulled within the interior of the device; andd. continuing to draw a negative pressure in the interior until an indication is received that the septum or other tissue has been pulled past a stationary needle disposed within the interior.2. The method of claim 1 , wherein claim 1 , upon receipt of the indication claim 1 , the negative pressure is increased to zero.3. The method of claim 1 , wherein claim 1 , upon receipt of the indication claim 1 , a lumen in which the negative pressure was drawn is valved off.4. The method of claim 1 , wherein the drawing a negative pressure includes coupling a syringe to a lumen claim 1 , the lumen in pressure communication with the ...

Transseptal Puncture Apparatus and Method for Using the Same

Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure. 1. A method comprising:telescopically disposing a blunt end cannula into a flexible introducer having an interior lumen, a distal curve, and a distal taper to define a predetermined shape and steerability to at least a distal portion of the introducer, where the flexible introducer has insufficient columnar strength and unsuitable shape for accessing a selected location on the cardiac septal wall of a patient's heart when the cannula is not disposed within the interior lumen of the introducer and in close proximity to the distal taper thereof, but is able to access the predetermined location on the cardiac septal wall when the cannula is disposed within the interior lumen of the introducer and in close proximity to the distal taper thereof;intravascularly accessing a right atrium of a patient's heart with the introducer;steering the distal taper of the introducer to the selected location on a septal wall of the heart to tent the septal wall at the selected location;advancing a sharp ended floppy guidewire telescopically disposed within an interior lumen of the cannula while being supported by the cannula to provide sufficient columnar strength to the floppy guidewire to allow it to be pushed through the septal wall into a left atrium of the patient's heart; andadvancing the sharp ended floppy ...

TRANSEPTAL NEEDLE WITH LOW TIP PRESSURE DESIGN

A method and device for puncturing the atrial septum to gain access to the left atrium without causing unintended injury to left atrial tissue. Specifically, the device includes a transseptal needle having a compressible shaft and a puncturing tip. As the transseptal needle is advanced through a delivery sheath and into contact with the septum, the compressible shaft is compressed and stores a minimal amount of mechanical energy but allows force transfer along its length. Force continues to be applied to the needle by the user until the puncturing tip punctures the septum. As the puncturing tip advances through the puncture and into the left atrium, any mechanical energy stored in the compressible shaft is immediately released, and the transfer of force is discontinued, by physical deformation of the compressible shaft. Thus, the puncturing tip enters the left atrium without causing injury to left atrial wall tissue. 1. A transseptal device , comprising:a needle including a compressible shaft with a proximal portion and a distal portion, the distal portion having a puncturing tip.2. The transseptal device of claim 1 , wherein the compressible shaft is configured to compress when a force is applied to the proximal portion of the compressible shaft.3. The transseptal device of claim 2 , wherein the needle is configured to be advanced through a delivery sheath claim 2 , the compressible shaft being configured to be compressed when the needle is within the delivery sheath and uncompressed when the needle is advanced distally out of the delivery sheath.4. The transseptal device of claim 1 , wherein the puncturing tip has a distalmost surface.5. The transseptal device of claim 4 , wherein the distalmost surface of the puncturing tip is tapered to a point configured to puncture septal tissue.6. The transseptal device of claim 1 , wherein the puncturing tip is composed of a low-mass material.7. The transseptal device of claim 2 , wherein the compressible shaft is a spring.8 ...

PERICARDIAL INFLATION CATHETER AND SYSTEMS AND METHODS EMPLOYING SAME

A method for performing a therapeutic intervention in a pericardial space of a heart includes delivering a catheter into a right atrium of the heart and steering the catheter so that a distal end of the catheter is positioned adjacent an access site in the right atrium. The distal end of the catheter is anchored in a heart wall of the right atrium adjacent the access site and the heart wall is inverted to separate an exterior surface of the inverted heart wall from contact with parietal pericardial tissue. The inverted heart wall is penetrated to provide access to the pericardial space around the heart. A device is delivered through the penetrating in the inverted heart wall to perform the therapeutic intervention in the pericardial space. 1. A method for performing a therapeutic intervention in a pericardial space of a heart , the method comprising:delivering a catheter into a right atrium of the heart;steering the catheter within the right atrium so that a distal end of the catheter is positioned adjacent an access site in the right atrium;anchoring the distal end of the catheter in a heart wall of the right atrium adjacent the access site;inverting the heart wall at the access site to separate an exterior surface of the inverted heart wall from contact with parietal pericardial tissue;penetrating the inverted heart wall at the access site to provide access to the pericardial space of the heart; anddelivering a device through a penetration in the inverted heart wall to perform the therapeutic intervention in the pericardial space of the heart.2. The method of claim 1 , wherein anchoring the distal end of the catheter in the heart wall comprises engaging the heart wall with an anchoring member that is disposed within a lumen of the catheter.3. The method of claim 2 , wherein the anchoring member comprises a rotatable screw claim 2 , a barb claim 2 , a hook claim 2 , a snare claim 2 , or a suction device.4. The method of claim 2 , further comprising retracting the ...

Magnetic Resonance Compatible RF Transseptal System

An MR compatible RF transseptal needle system is provided. The transseptal needle system includes a transseptal needle having a main cannula portion and a distal tip portion; and a delivery tool with a distal tip electrode. In some embodiments the transseptal needle system further includes a linear position measurement mechanism including a wiper member; and two or more conductive strip members. 1. An MR compatible RF transseptal needle system comprising:a transseptal needle having a main cannula portion and a distal tip portion;a delivery tool with a distal tip electrode.2. The MR compatible RF transseptal needle system of wherein the distal tip portion of the transseptal needle is a conductive material such as copper claim 1 , gold claim 1 , platinum iridium claim 1 , stainless steel claim 1 , MP35n claim 1 , or the like.3. The MR compatible RF transseptal needle system of wherein the main cannula portion is comprised of an MR safe material such as PEEK claim 1 , grilamid claim 1 , polyimide claim 1 , fiber claim 1 , nylon claim 1 , fiber re-enforced epoxy claim 1 , ceramic claim 1 , or some other polymer.4. The MR compatible RF transseptal needle system of wherein the delivery tool distal tip electrode is a conductive material such as copper claim 1 , gold claim 1 , platinum iridium claim 1 , stainless steel claim 1 , MP35 claim 1 , or the like.5. The MR compatible RF transseptal needle system of wherein the delivery tool distal tip electrode is a ring electrode.6. The MR compatible RF transseptal needle system of wherein the delivery tool distal tip electrode is positioned within the inner lumen of the delivery tool.7. The MR compatible RF transseptal needle system of wherein the delivery tool distal tip electrode is positioned at a tip of the delivery tool.8. The MR compatible RF transseptal needle system of wherein the delivery tool distal tip electrode is operably coupled to one or more conduction lines.9. The MR compatible RF transseptal needle system of ...

METHODS AND DEVICES FOR DIASTOLIC ASSIST

The devices and method described herein allow for therapeutic damage to increase volume in these hyperdynamic hearts to allow improved physiology and ventricular filling and to reduce diastolic filling pressure by making the ventricle less stiff. For example, improving a diastolic heart function in a heart by creating at least one incision in cardiac muscle forming an interior heart wall of the interior chamber where the at least one incision extends into one or more layers of the interior heart wall without puncturing through the interior heart wall and the incision is sufficient to reduce a stiffness of the interior chamber to increase volume of the chamber and reduce diastolic filing pressure. 1positioning a medical device within a body of the patient;advancing the medical device into an interior chamber of the heart;creating at least one incision in cardiac muscle forming an interior heart wall of the interior chamber without cutting through the interior heart wall, where the incision is sufficient to reduce a stiffness of the interior chamber to increase volume of the chamber and reduce diastolic filing pressure.. A method of improving a diastolic heart function in a heart of a patient having diastolic heart dysfunction, the method comprising: This application is a continuation of U.S. patent application Ser. No. 12/176,564, filed on Feb. 10, 2014, which is a divisional of U.S. patent application Ser. No. 13/277,158, filed on Oct. 19, 2011, which claims the benefit of U.S. Provisional Application Nos. 61/394,759 filed on Oct. 19, 2010; 61/478,495 filed on Apr. 23, 2011; and 61/504,641 filed on Jul. 5, 2011, the contents of which are incorporated herein by reference in its entirety.Congestive heart failure (CHF) in the United States has a prevalence of approximately 5.8 million people and an incidence of approximately 550,000 people annually. CHF is a rapidly growing medical problem. CHF can be categorized as either systolic heart failure (SHF) or diastolic ...

Surgical system and related methods

A surgical system can include a surgical probe having a deflectable tip, and a plurality of guide arms that are movable so as to cause the tip to deflect. Thus, the surgical probe can be steered toward a target anatomical location. The surgical system can further include a control system that includes a free floating user interface, and a motion sensor that detects motion of the user interface. The control system is configured to cause the probe tip to deflect in response to the detected motion of the user interface.

STEERABLE LESION EXCLUDING HEART IMPLANTS FOR CONGESTIVE HEART FAILURE

Devices, systems, and methods for treating a heart of a patient may make use of one or more implant structures which limit a size of a chamber of the heart, such as by deploying a tensile member to bring a wall of the heart toward (optionally into contact with) a septum of the heart. 120.-. (canceled)21. A method for treating a heart , the heart having a first chamber bordered by a septum and a wall , wherein the chamber comprises a left ventricle of the heart , the heart having a second chamber separated from the first chamber by the septum , the method comprising:providing a perforation device having a distal tip that is configured to deliver electrosurgical energy to heart tissue to enable the perforation device to penetrate through the heart tissue;penetrating, via the perforation device, the septum at a first location selected for deployment of an implant;penetrating, via the perforation device, the wall at a second location selected for the deployment of the implant;controllably steering the perforation device between the first location and the second location; anddeploying the implant by affixing a first anchor of the implant adjacent the penetration of the septum, affixing a second anchor of the implant adjacent the penetration of the wall, and applying tension between the first anchor and the second anchor;wherein the tensioned members are tensioned sufficiently to bring the wall and septum into engagement, and thereby effectively exclude a region of the wall and septum from the left ventricle with scar tissue extending along the excluded region.22. The method of claim 21 , further comprising sensing a pressure from a distal end of the perforation device advancing through the heart tissue at the first and/or second locations so as to characterize the tissue.23. The method of claim 21 , further comprising penetrating the wall at a plurality of additional locations claim 21 , wherein a plurality of separate implants are deployed claim 21 , each deployed ...

Apical control of transvascular delivery of prosthetic mitral valve

Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve. In some embodiments, after a prosthetic valve has been at least partially delivered from a delivery sheath into the left atrium of a heart, a valve positioning device can be used to engage with and position the prosthetic valve within the mitral annulus. The valve positioning device can include an alignment member configured to engage with a prosthetic valve such that the alignment member can control the distal, proximal, lateral and/or rotational movement of the prosthetic valve. The prosthetic valve can include a tether that can be inserted or threaded through the alignment member such that the alignment member can be moved along the tether into engagement with the prosthetic valve.

Apparatus And Methods For Alignment And Deployment Of Intracardiac Devices

Apparatus and methods are described herein for use in the alignment and deployment of a prosthetic heart valve, such as a mitral valve. In some embodiments, an apparatus includes a tube assembly and a needle assembly configured to be received through a lumen of an outer tube member of the tube assembly. The needle assembly includes an elongate needle having a distal tip configured to be inserted through the epicardial surface of a heart. An imaging probe is coupled to a coupling member and includes an imaging element. The imaging probe is configured to provide image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of the mitral valve and the annular region of the heart such that a prosthetic mitral valve can be positioned within the heart based at least in part on the C-C plane and the A-P plane. 1. A method , comprising:positioning an alignment device near an epicardial surface of a heart of a patient such that an imaging element mounting member of the alignment device is disposed in contact with the epicardial surface of the heart, the alignment device including a tube assembly including an outer tube member and a coupling member, and a needle assembly movably disposed at least partially within a lumen of the outer tube member, the needle assembly including a needle tube and an elongate needle movably disposed within the needle tube;actuating the alignment device to image the heart with an imaging element coupled to the imaging element mounting member, the imaging producing image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of a mitral valve and an annular region of the heart;determining an insertion point on the epicardial surface for the needle assembly;inserting a distal end portion of the needle assembly through the epicardial surface at the insertion point and into a left ventricle of the heart;removing ...

Transcatheter anchoring assembly for a mitral valve, a mitral valve, and related methods

A medical assembly implanting a transcatheter heart valve in the heart at a valve deployment site and related methods of implantation and delivery. An anchor is endovascularly introduced into the heart and implanted to a cardiac wall with an anchor delivery system and delivery cable. A second delivery system introduces a tether which coupled to the implanted anchor and a transcatheter heart valve. The transcatheter heart valve includes either a top or bottom brim which is positioned to conform to the atrial floor at the deployment site.

DIRECTIONAL BALLOON TRANSSEPTAL INSERTION DEVICE FOR MEDICAL PROCEDURES WITH IMPROVED TRANSSEPTAL PUNCTURE SYSTEM WITH PUNCTURE MEMBER BALLOON SEAL

The disclosed invention provides a transseptal insertion device which is suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum. The transseptal insertion device includes a sheath that defines at least one lumen therein, one or more positioning balloons that are connected to a distal end of the sheath, a puncture member movably positioned within the at least one lumen, and a puncture member balloon located on the puncture member. The positioning balloons are inflated and deflated through hypotubes, and the puncture member balloon is inflated and deflated through an additional tube. The transseptal insertion device includes a wire member movably positioned in a center lumen formed in the puncture member. The wire member may be Brockenbrough needle, a radiofrequency tip needle, a radiofrequency wire, a pigtail catheter that delivers fluid or pharmaceuticals in the left atrial appendage, or a transseptal wire. 1. A transseptal insertion device which is suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum , comprising:a sheath that defines at least one lumen therein and has a distal end that is positioned toward the cardiac interatrial septum of a patient when the transseptal insertion device is in use and a proximal end that is external to the patient;one or more positioning balloons that are connected to the distal end of the sheath, wherein the one or more positioning balloons, when inflated and the transseptal insertion device is in use, overhang and extend past the distal end of the sheath, wherein the sheath includes one or more hypotubes respectively connected to the one or more positioning balloons to inflate and deflate the one or more positioning balloons;a puncture member movably positioned within the at least one lumen, wherein the puncture member has a distal end that is positioned toward the cardiac interatrial septum of the patient, wherein the puncture member has a distal ...

Catheters and dilators for trans-septal procedures and methods for making and using them

Devices and methods are provided for performing a medical procedure using a trans-septal approach. The device includes a dilator including a proximal end, a distal end terminating in a distal tip, and a lumen extending between the dilator proximal and distal ends, and a needle device including a proximal end, a distal end sized for introduction into the dilator lumen and terminating in a sharpened distal tip. The needle is movable relative to the dilator to selectively expose the needle device distal tip distally from the dilator lumen and advance the dilator relative to the needle device. The dilator may have a complex tapered shape on its distal tip, e.g., including first and second tapered regions. The needle device may include an inner needle including the sharpened distal tip and an outer tube including a substantially blunt distal end that slidably receives the inner needle.

Steerable endoluminal punch

A steerable transseptal punch system and method of using the steerable transseptal punch system to access the left atrium.

Apparatus and method for targeting a body tissue

An apparatus for targeting a desired target site on a body tissue that separates a first body cavity from a second body cavity of a patient includes a catheter having a longitudinally extending catheter lumen and adapted to provide access to the first body cavity. A framing member has a collapsed condition in which the framing member is adapted for insertion into the first body cavity through the catheter lumen and an expanded condition in which the framing member is adapted for placement within the first body cavity. The framing member has a framing member body. At least one target point is carried by the framing member and is adapted for placement adjacent the desired target site. At least one target pathway is attached to at least one target point. At least a portion of the target pathway extends through the catheter lumen. The target pathway is substantially spaced apart from the framing member body. A method of using the apparatus is also described.

FOSSA OVALIS PENETRATION

Apparatus and methods are described, including a catheter shaped to define a catheter lumen. A wall of the catheter comprises a braided portion, and is shaped to define first and second longitudinally-running channels therethrough. A distal portion of the catheter is shaped to define first and second lateral openings, which are approximately equidistant from the distal end of the catheter. A flexible longitudinal member passes (a) from a proximal portion of the catheter to the distal portion of the catheter via the first channel, (b) out of the first channel via the first lateral opening, (b) into the second channel via the second lateral opening, and (c) from the distal portion of the catheter to the proximal portion of the catheter via the second channel. Other applications are also described. 120-. (canceled)21. Apparatus comprising:a hollow needle comprising:a proximal portion having an outer diameter between 0.7 and 3 mm, a length between 650 and 1200 mm, and a wall thickness between 0.1 and 0.3 mm; anda helical distal portion having an outer diameter between 0.5 and 1.5 mm and a length between 50 and 200 mm; anda fluid-impermeable cover surrounding the helical distal portion of the needle.22. (canceled)23. Apparatus comprising:a hollow needle comprising:a proximal portion having an outer diameter between 0.7 and 3 mm, a length between 650 and 1200 mm, and a wall thickness between 0.1 and 0.3 mm; anda distal portion (a) having an outer diameter between 0.5 and 1.5 mm and a length between 50 and 200 mm, and (b) comprising a wall that is shaped to define a plurality of openings that pass completely therethrough; anda fluid-impermeable cover surrounding the laser-cut distal portion of the needle.24. The apparatus according to claim 23 , wherein the wall of the distal portion of the hollow needle is shaped to define a plurality of slits therethrough.2534-. (canceled)36. A method for puncturing a fossa ovalis of a heart claim 23 , the method comprising:inserting a ...

STEERABLE ENDOLUMINAL PUNCH

An endoluminal needle or punch is describes wherein the distal end of the endoluminal needle is able to articulate laterally out of the longitudinal axis of the steerable endoluminal needle. The endoluminal needle further comprise a blunted distal end configuration that is minimally traumatic. Under control by the user, at the proximal end of the endoluminal needle, a sharp stylet can be advanced to punch tissue and then be retracted to maximize safety. The endoluminal needle is configured for use within an introducer. 1. A device for penetrating a body lumen or hollow organ of a mammal comprising:an outer tube, said outer tube characterized by a distal end, and proximal end, and an outer tube lumen extending from the distal end to the proximal end thereof, said outer tube having a flexible region near the distal end of the outer tube;a first control rod disposed with the outer tube, said first control characterized by a distal end and a proximal end; wherein the control rod is fixed to the distal end of the outer tube and extends proximally to the proximal end of the outer tube; anda second control rod disposed with the outer tube, said first control characterized by a distal end and a proximal end; wherein the control rod is fixed to the distal end of the outer tube and extends proximally to the proximal end of the outer tube; whereinthe first control rod and the second control rod comprise partial cylinders disposed coaxially within the outer tube.2. The device of further comprising a fluid impermeable tubular liner dispose within the outer tube lumen claim 1 , and within the first and second control rod.3. The device of further comprising:a keeper, comprising a partial cylinder, disposed within the outer tube, in the flexible region, and disposed radially displaced from the first and second control rods, wherein said keeper is not fixed directly to the control rod.4. The device of claim 3 , wherein the keeper is free-floating within the outer tube.5. A device ...

Steerable endoluminal punch with cutting stylet

An endoluminal punch with a penetrating stylet and a vibration generator. The vibration generator is operable to cause vibrations and rapid reciprocation of the distal tip of the stylet to facilitate penetration of the stylet through resistant body tissue such as the fossa ovalis. The vibration generator may also be operable to cause vibration of the distal tip of the punch itself, to facilitate passage of the punch through an initial perforation created by the stylet.

Reflectance-facilitated ultrasound treatment and monitoring

Apparatus comprising an ultrasound ablation system, which comprises a reflection-facilitation element, configured to be placed at an extramyocardial site of a subject, and to provide an extramyocardial reflective region; and an ultrasound tool, which comprises at least one ultrasound transducer configured to be positioned within a heart chamber of the subject. The ultrasound transducer is configured to ablate myocardial tissue by applying ultrasound energy to the myocardial tissue such that at least a portion of the transmitted energy is reflected by the reflective region onto the myocardial tissue. Other embodiments are also described.

Transseptal insertion device

A transseptal insertion device is provided including device housing, a pusher slidably disposed in the device housing and a guide element extending from the pusher. The device housing is configured to be inserted into the right atrium of a patient's heart and the guide element can then be advanced from the device housing and against the cardiac septum to facilitate stable puncturing of the cardiac septum by a needle carried by a catheter inserted through the device housing, to provide access to the left atrium. The guide element can be formed as a webbing or ring. The pusher and/or guide element can optionally be inflatable.

FOSSA OVALIS PENETRATION

A method is provided, including transvascularly inserting a guidewire into a right atrium of a subject. Apparatus is provided that includes (a) a catheter, and (b) a hollow needle disposed within a lumen of the catheter, the hollow needle including a proximal portion and a distal portion that is more flexible than the proximal portion. The apparatus is passed into the right atrium by passing the needle over the guidewire. Following the passing of the apparatus into the right atrium, the guidewire is partially withdrawn into the needle, while keeping a distal end of the guidewire within the needle and in a body of the subject. Thereafter, a hole is formed through an interatrial septum of the subject with the needle. Other embodiments are also described. 1. A method comprising:transvascularly inserting a guidewire into a right atrium of a subject;providing apparatus that includes (a) a catheter and (b) a hollow needle disposed within a lumen of the catheter, the hollow needle including a proximal portion and a distal portion that is more flexible than the proximal portion;passing the apparatus into the right atrium by passing the needle over the guidewire;following the passing of the apparatus into the right atrium, partially withdrawing the guidewire into the needle, while keeping a distal end of the guidewire within the needle and in a body of the subject; andthereafter, forming a hole through an interatrial septum of the subject with the needle.2. The method according to claim 1 , further comprising claim 1 , after forming the hole through the interatrial septum claim 1 , advancing the guidewire into a left atrium of the subject.3. The method according to claim 2 , further comprising claim 2 , after advancing the guidewire into the left atrium claim 2 , proximally withdrawing the needle from the right atrium.4. The method according to claim 3 , further comprising claim 3 , after proximally withdrawing the needle from the right atrium claim 3 , introducing claim 3 , ...

STEERABLE ENDOLUMINAL PUNCH WITH CUTTING STYLET

An endoluminal punch with a penetrating stylet and a vibration generator. The vibration generator is operable to cause vibrations and rapid reciprocation of the distal tip of the stylet to facilitate penetration of the stylet through resistant body tissue such as the fossa ovalis. The vibration generator may also be operable to cause vibration of the distal tip of the punch itself, to facilitate passage of the punch through an initial perforation created by the stylet. 1. An endoluminal punch comprising:a first tube having a proximal end, a distal end, and a lumen extending from said proximal end to said distal end, said first tube having a sharp distal tip;a stylet having a proximal end and a distal end, said stylet slidably and rotatably disposed within the lumen of the inner tube, with a spiral wire section and a sharp distal tip at the distal end of the stylet, said spiral wire section being resilient and configured to be inserted through, and withdrawn through the first tube.2. The endoluminal punch of claim 1 , further comprising:a motor operably connected to the proximal end of the stylet, said motor operable to rotate the stylet within the lumen of the first tube.3. The endoluminal punch of claim 2 , wherein:the motor comprises a hollow shaft, and the proximal end of the stylet is disposed within said hollow shaft and extends proximally from the motor, and the stylet is longitudinally translatable within the hollow shaft.4. The endoluminal punch of claim 1 , further comprising:a second tube, disposed about the first tube, said second tube having a proximal and a distal end, wherein the first tube is longitudinally fixed to the second tube proximate the distal end of the second tube;whereby the first tube may be tensioned relative to the second tube to cause deflection of a distal portion of the endoluminal punch.5. An endoluminal punch comprising:a first tube having a proximal end, and distal end, and a lumen extending from said proximal end to said distal ...

METHOD AND DEVICE FOR SAFE PERCUTANEOUS PERICARDIAL DRAINAGE

A safe, reliable, reproducible system and method for entry into the pericardial sac. The method and system described generally includes penetration of the subcutaneous tissue with a guide sheath or a relatively blunt stylet contained within a sheath. The stylet is removed from the sheath and a hook mechanism is installed. Once in contact with the pericardium, the hook is engaged with the pericardial tissue, allowing the hook mechanism to draw the pericardium away from the heart to create a greater space between the heart and pericardium allowing needle insertion into the pericardial cavity in a much safer and controlled manner. 1. A system for safe entry into a pericardial sac (membrane) , comprising:an outer sheath with at least one lumen therein; anda hooking/grasping mechanism positioned within said lumen, said hooking/grasping mechanism having an engagement member on an end thereof.2. The system of claim 1 , said engagement member further comprising a spiral shaped hook extending from said hooking mechanism.3. The system of claim 2 , wherein a distal end of said engagement member is disposed approximately 90 degrees relative to a longitudinal axis extending through said hooking mechanism.4. The system of claim 2 , wherein rotation of said hooking mechanism causes said engagement member to penetrate and engage a pericardial membrane5. The system of claim 1 , said engagement member further comprising at least one hook extending from said engagement member.6. The system of claim 5 , wherein a distal end of said engagement member is disposed approximately 90 degrees relative to a longitudinal axis extending through said hooking mechanism.7. The system of claim 5 , wherein rotation of said hooking mechanism causes said engagement member to penetrate and engage a pericardial membrane8. The system of claim 1 , said hooking mechanism having a lumen therein for insertion of a large bore needle.9. The system of claim 8 , further comprising a guide wire inserted within ...

METHODS AND DEVICES FOR DIASTOLIC ASSIST

The devices and method described herein allow for therapeutic damage to increase volume in these hyperdynamic hearts to allow improved physiology and ventricular filling and to reduce diastolic filling pressure by making the ventricle less stiff. For example, improving a diastolic heart function in a heart by creating at least one incision in cardiac muscle forming an interior heart wall of the interior chamber where the at least one incision extends into one or more layers of the interior heart wall without puncturing through the interior heart wall and the incision is sufficient to reduce a stiffness of the interior chamber to increase volume of the chamber and reduce diastolic filing pressure. 1positioning a medical device within a body of the patient;advancing the medical device into an interior chamber of the heart;creating at least one incision in cardiac muscle forming an interior heart wall of the interior chamber without cutting through the interior heart wall, where the incision is sufficient to reduce a stiffness of the interior chamber to increase volume of the chamber and reduce diastolic filing pressure.. A method of improving a diastolic heart function in a heart of a patient having diastolic heart dysfunction, the method comprising: This application is a continuation of U.S. patent application Ser. No. 15/719,347, filed on Sep. 28, 2017, which is a continuation of U.S. patent application Ser. No. 12/176,564, filed on Feb. 10, 2014, which is a divisional of U.S. patent application Ser. No. 13/277,158, filed on Oct. 19, 2011, which claims the benefit of U.S. Provisional Application Nos. 61/394,759 filed on Oct. 19, 2010; 61/478,495 filed on Apr. 23, 2011; and 61/504,641 filed on Jul. 5, 2011, the contents of which are incorporated herein by reference in its entirety.Congestive heart failure (CHF) in the United States has a prevalence of approximately 5.8 million people and an incidence of approximately 550,000 people annually. CHF is a rapidly growing ...

Atrial appendage closure device and related methods

An atrial appendage closure device is provided that includes an insertion rod having a first end and a second end. An occluding member having an outer surface and an inner surface is connected to the first end of the insertion rod. The occluding member is moveable between a retracted position and a deployed position such that, in the deployed position, the occluding member is configured to provide a seal between a left atrial appendage and a left atrium of a heart. An anchoring member is further connected to the insertion rod and is configured to slide along the insertion rod to secure the device to a wall of a left atrial appendage. Methods for occluding a left atrial appendage that make use of the closure devices are also provided.

DUAL LUMEN DILATOR FOR USE IN TRANSSEPTAL PUNCTURES

A dilator assembly comprising an elongated body having a proximal end and a distal end, a first lumen extending along the body, a second lumen extending along the body so that it is a parallel to the first lumen, and a joint lumen disposed adjacent the distal end of the body, wherein both the first lumen and second lumen are in fluid communication with the joint lumen. A guidewire has a first end and a second end, and the first end of the guidewire is slidably received in the first lumen and the second end of the guidewire is slidably received in the second lumen. 1. A dilator assembly comprising;an elongated body having a proximal end and a distal end, a first lumen extending along the body, a second lumen extending along the body so that it is a parallel to the first lumen, and a joint lumen disposed adjacent the distal end of the body, wherein both the first lumen and second lumen are in fluid communication with the joint lumen; anda guidewire having a first end and a second end,wherein the first end of the guidewire is slidably received in the first lumen and the a second end of the guidewire is slidably received in the second lumen.2. The dilator assembly of claim 1 , further comprising:a first lumen having a first luer line that is fluid communication with the first lumen; anda second luer having a second luer line that is in fluid communication with the second lumen.3. The dilator assembly of claim 2 , further comprising:a control hub, wherein the elongated body extends outwardly from a first end of the central hub and the first and the second luer lines extend outwardly from a second end of the central hub.4. The dilator assembly of claim 2 , wherein the distal end of the elongated body includes a tapered end.5. The dilator assembly of claim 4 , wherein the tapered end of the elongated body is defined by an outer frustoconical surface.6. A dilator assembly for use with a guidewire having a first end and second end claim 4 , comprising;an elongated body ...

TRANSAPICAL INTRODUCER

A transapical introducer includes a housing near a proximal end of the introducer, a first valve in the housing, a proximal tube coupled to the housing, and a distal tube coupled to a distal end of the proximal tube. 1. An introducer comprising:a housing near a proximal end of the introducer;a foam seal located in the housing;a flexible proximal tube coupled to the housing; anda rigid distal tube coupled to a distal end of the proximal tube;wherein the proximal tube is more flexible than the distal tube and is capable of being clamped to prevent fluid flow therethrough.2. The introducer of claim 1 , wherein the proximal tube is translucent.3. The introducer of claim 1 , wherein the foam seal includes a first slit on a first surface of the foam seal and a second slit on a second surface of the foam seal claim 1 , the first surface being opposite the second surface and the first slit being generally perpendicular to the second slit.4. The introducer of claim 1 , wherein the housing further comprises a shoulder and a housing cap claim 1 , the foam seal being positioned between the shoulder and the housing cap.5. The introducer of claim 4 , wherein the housing further comprises at least one foam seal retaining element.6. The introducer of claim 5 , wherein the at least one foam seal retaining element is a spike extending radially inward from the housing.7. The introducer of claim 4 , wherein the housing further comprises a plurality of spikes spaced circumferentially around an inside of the housing claim 4 , each of the plurality of spikes extending radially inward from the housing.8. The introducer of claim 1 , wherein the proximal tube is formed of a material selected from the group consisting of polytetrafluoroethylene claim 1 , polyfluoroethylene claim 1 , polyurethane claim 1 , and polyethylene.9. The introducer of claim 1 , wherein the distal tube is formed of a material selected from the group consisting of stainless steel claim 1 , carbon reinforced nylon claim ...

Pericardial access device

A method is provided for accessing a pericardial space of a subject. The method includes advancing a guide member toward a heart, having (a) a transparent blunt distal end, and (b) a side-facing suction port. During advancing of the guide member, an imaging device disposed in the guide member generates an image of part of the heart. Subsequently to contacting the pericardium with the suction port, the imaging device is retracted proximally in the guide member. Subsequently, a portion of the pericardium is drawn into the guide member through the suction port. Following the drawing of the portion into the guide member, an image of the pericardium disposed within the suction port, is generated. Subsequently, a puncturing element is advanced in the guide member to puncture the portion of the pericardium that is in the guide member. Other applications are also described.

Steerable Guidewire and Method of Use

A steerable guidewire. The steerable guidewire is fabricated includes an outer tube, an inner tube, a hub, and a distal articulating region. The steerable guidewire hub can be removed to permit advancement of catheters over its proximal end followed by re-attachment of the hub to permit deflection of the distal end of the steerable guidewire. 1. A steerable guidewire comprising:an outer tube characterized by a proximal end, a distal end, and a flexible region at said distal end of the outer tube, said flexible region also characterized by a proximal and a distal end; andan inner tube characterized by a proximal end and a distal end, and a flexible region near said distal end of the inner tube;said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally proximate the distal end of the outer tube, said inner tube longitudinally fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube; whereinthe flexible region of the outer tube comprises a segment of the outer tube which is snake-cut with a plurality of radially oriented slots in the wall of the outer tube, said radially oriented slots being radially aligned along one side of the outer tube; andthe flexible region of the inner tube comprises a segment of the inner tube with a longitudinally oriented slot, wherein said longitudinally oriented slot divides the flexible region of the inner tube into a first partial cylinder segment and a second partial cylinder segment.2. The steerable guidewire of claim 1 , wherein the longitudinally oriented slot of the inner tube terminates at one end in an angled lead-in communicating from the longitudinally oriented slot claim 1 , at an angle to a longitudinal axis of the inner tube claim 1 , and opening through the side wall of the inner tube.3. The steerable guidewire of claim 1 , wherein the inner tube is fixed to ...

FOSSA OVALIS PENETRATION CATHETER

Apparatus for puncturing a fossa ovalis includes a catheter shaped so as to define a central catheter lumen open through a catheter distal end opening. An angle between (i) a first line running between first and second lateral openings defined by the catheter and (ii) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight, is between 30 and 150 degrees. A flexible longitudinal member passes (a) from a proximal portion of the catheter to a distal portion of the catheter, (b) out of the first lateral opening, and (c) into the second lateral opening, so as to form a loop outside the catheter. The flexible longitudinal member is configured to assume a deployment configuration in which a distal-most portion of the loop is curved and is distal to the catheter distal end opening. Other embodiments are also described. 152-. (canceled)53. Apparatus for puncturing a fossa ovalis , the apparatus comprising:a catheter, which (a) has a distal portion that is shaped so as to define a catheter distal end opening at a distal end of the catheter, and first and second lateral openings, and (b) is shaped so as to define a central catheter lumen open through the catheter distal end opening, wherein an angle between (i) a first line running between the first and the second lateral openings and (ii) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight, is between 30 and 150 degrees; anda flexible longitudinal member, which:passes (a) from a proximal portion of the catheter to the distal portion of the catheter, (b) out of the first lateral opening, and (c) into the second lateral opening, so as to form a loop outside the catheter, andis configured to assume a deployment configuration in which a distal-most portion of the loop is curved and is distal to the catheter distal end opening.54. The apparatus according to claim 53 , wherein the angle between the first and the second lines ...

Medical apparatus for fluid communication

This disclosure describes embodiments of a kit and its constituent components which together form an apparatus in which fluid communication between a medical device's lumen and the surrounding environment is provided by a conduit cooperatively defined by the medical device and a tubular member into which the device is inserted. The medical device and tubular member are configured to fit together such that an outer surface of the distal region of the medical device cooperates with an inner surface of the tubular member to define the conduit between the side-port of the medical device and a distal end of the tubular member. The conduit is operable to be used for injecting fluid, withdrawing fluid, and measuring pressure, for example. Methods of assembling and using the apparatus are described as well.

TRANSCATHETER MEDICAL IMPLANT DELIVERY

A medical implant delivery system can comprise a puncture needle, a medical implant delivery catheter and the puncture needle being configured to be slidably advanced through a puncture needle lumen of the medical implant delivery catheter, a medical implant device positioned on the medical implant delivery catheter, and an outer delivery catheter comprising a medical implant delivery lumen, the medical implant delivery catheter being configured to slidably extend through the medical implant delivery lumen. A medical implant delivery system can comprise a puncture needle, a medical implant delivery catheter and the puncture needle being configured to slidably extend through the puncture needle lumen of the medical implant delivery catheter, a medical implant device positioned on the medical implant delivery catheter, an elongate housing adjacent to the medical implant delivery catheter, and an outer sheath around a portion of the medical implant delivery catheter and the elongate housing. 1. A medical implant delivery system comprising:a puncture needle comprising an elongate portion and a puncture component associated with a distal end of the elongate portion, the puncture component being configured to pierce and form an opening in a target tissue wall;a medical implant delivery catheter comprising a puncture needle lumen, the puncture needle being configured to be advanced through the puncture needle lumen, the puncture component being configured to be extended through a puncture needle outlet opening associated with a distal portion of the medical implant delivery catheter;a medical implant device positioned on the medical implant delivery catheter; andan outer delivery catheter comprising a medical implant delivery lumen, the medical implant delivery catheter being configured to be advanced through the medical implant delivery lumen, the distal portion of the medical implant delivery catheter being configured to be received within the medical implant delivery ...

Adjustable Heart Valve Implant

Systems and methods are provided for repairing a heart valve, such as a mitral, tricuspid or aortic valve, using an adjustable and removable implant that can be delivered to the heart through the apex in a simplified and non-invasive manner. The implant can include a prosthetic valve portion coupled to a proximal end of a shaft, and an anchor portion coupled to a distal end of the shaft. The prosthetic valve can be suspended within an opening of the heart valve while the anchor portion is affixed to the apex of the heart. When the implant is deployed, a distance between the prosthetic valve portion and the anchor portion can be adjusted, and/or the implant or a portion thereof can be rotated to thereby change the position of the prosthetic valve within the heart valve. This can allow correcting for post-implantation movements of the implant to mitigate potential complications. 1. A system for repairing a heart valve , comprising:an outer shaft; andan implant disposed within the outer shaft, the implant including an inner shaft, a prosthetic valve coupled to a distal end of the inner shaft and having a prosthetic valve body and at least one positioning member, the prosthetic valve being configured to be distally advanced from the outer shaft such that the prosthetic valve moves from an unexpanded configuration, and the at least one positioning member being configured to suspend the prosthetic valve within an opening in tissue, and an anchor portion coupled to a proximal end of the inner shaft and configured to be removably affixed to tissue;wherein a distance between the prosthetic valve and the anchor portion is adjustable.2. The system of claim 1 , wherein the prosthetic valve body comprises prosthetic valve leaflets and the at least one positioning member comprises at least two arms coupled to the prosthetic valve body.3. The system of claim 1 , wherein the prosthetic valve body comprises an expandable frame and the at least one positioning member comprises an ...

Adjustable Heart Valve Implant

Systems and methods are provided for repairing a heart valve, such as a mitral, tricuspid or aortic valve, using an adjustable and removable implant that can be delivered to the heart through the apex in a simplified and non-invasive manner. The implant can include a prosthetic valve portion coupled to a proximal end of a shaft, and an anchor portion coupled to a distal end of the shaft. The prosthetic valve can be suspended within an opening of the heart valve while the anchor portion is affixed to the apex of the heart. When the implant is deployed, a distance between the prosthetic valve portion and the anchor portion can be adjusted, and/or the implant or a portion thereof can be rotated to thereby change the position of the prosthetic valve within the heart valve. This can allow correcting for post-implantation movements of the implant to mitigate potential complications.

SYSTEMS AND METHODS FOR HELICALLY ADVANCING SUTURE IN TISSUE

Systems and methods for providing transapical access to a heart chamber for performing an intra cardiac procedure are described. The systems include a helical needle driver and a dilator. The helical needle driver rotates and translates a shuttle member which advances one or more helical needles to place a helical suture within the myocardium. After removing the needles, the dilator is advanced through the pre-placed helical suture, dilating both a passage and the circumscribing suture. After performing procedure, the pre-placed suture may be closed by proximally retracting an external end of the suture. 1. A system for helically advancing suture through tissue , said system comprising:a handle having a distal end, a proximal end, and a central passage extending between said ends;a knob rotatably carried on the proximal end of the handle;a shuttle member reciprocatably disposed in the central passage of the handle, said shuttle member having a distal end, a proximal end, and a central passage extending between said ends;at least one helical needle coupled to the distal end of the shuttle member; andsuture releasably carried by the at least one helical needle;wherein the knob is coupled to the shuttle member so that the rotation of the knob rotates and axially translates the shuttle member to rotate and translate the at least one helical needle, wherein the knob does not axially translate as it is rotated.2. A system for helically advancing suture through tissue as in claim 1 , further comprising a needle-dilator assembly adapted to be received through a central passage in the shuttle member.3. A system for helically advancing suture through tissue as in claim 2 , wherein the distal end of the handle is adapted to be engage a pericardial or myocardial surface of a patient's heart.4. A system for helically advancing suture through tissue as in claim 2 , wherein the handle is adapted to access the pericardial or myocardial surface of an apical region of the heart ...

DEVICES, SYSTEMS, AND METHODS FOR DELIVERING A SUBSTANCE WITHIN A MAMMALIAN LUMINAL ORGAN OR AREA ADJACENT THERETO

Devices, systems, and methods for delivering a substance within a mammalian luminal organ or area adjacent thereto. In at least one exemplary embodiment of a system of the present disclosure, the system comprises an inner delivery device, comprising an inner portion configured to receive a substance therein, a pock tip at or near a distal end of the inner delivery device, the pock tip configured to deliver the substance from the inner portion, through a pock tip aperture defined within the pock tip, and into a mammalian tissue and/or luminal organ, and an embolus positioned within the inner portion, the embolus configured so that the substance remains distal to the embolus when the substance is positioned within the inner portion. In another embodiment, the system further comprises an outer catheter, comprising an elongate body, a guidewire lumen defined within the elongate body and configured to receive at least part of a guidewire therein, and a central lumen defined within the elongate body, the central lumen configured to receive at least a portion of the inner delivery device. 1. An inner delivery device , comprising:an inner portion configured to receive a substance therein; anda pock tip at or near a distal end of the inner delivery device, the pock tip configured to deliver the substance from the inner portion, through a pock tip aperture defined within the pock tip, and into a mammalian tissue and/or luminal organ.2. The inner delivery device of claim 1 , further comprising:an embolus positioned within the inner portion, the embolus configured so that the substance remains distal to the embolus when the substance is positioned within the inner portion.3. The inner delivery device of claim 2 , further comprising:a delivery shaft positioned proximal to the embolus, the delivery shaft configured to fit within the inner delivery device and facilitate delivery of the substance by way of distal advancement of the embolus within the inner delivery device.4. The ...

Method and device for percutaneous left ventricular reconstruction

A method for reducing left ventricular volume, which comprises identifying infracted tissue during open chest surgery; reducing left ventricle volume while preserving the ventricular apex; and realigning the ventricular apex, such that the realigning step comprises closing the lower or apical portion of said ventricle to achieve appropriate functional contractile geometry of said ventricle in a dyskinetic ventricle of a heart.

Pericardial needle mechanism

Apparatus is provided including a surgical tool configured to be advanced distally within a body of a subject. The surgical tool is shaped to define a side-facing suction port at a distal portion of the surgical tool to facilitate drawing tissue through the suction port and into the surgical tool, and includes a slidable transparent shutter configured to be disposed over the suction port, and to be slidably removed from the suction port. A needle is configured to be slidably disposed within the surgical tool and configured to puncture the tissue while the tissue is in the surgical tool.

RADIAL AND TRANS-ENDOCARDIAL DELIVERY CATHETER

A needle-injection catheter includes a catheter body having a distal end, a proximal end, a stiff proximal portion, a flexible distal portion, and a delivery lumen extending therethrough. In a first embodiment, a straight injection needle extends coaxially from a distal tip of the flexible portion of the catheter body, and a plurality of penetration limiting elements positioned circumferentially about a base of the straight injection needle and configured to fold radially inwardly against a shaft of the needle when constrained in a tubular lumen and to extend radially outwardly when unconstrained. In a second embodiment, a helical needle extends from the distal tip of the flexible portion of the catheter body. The helical needle has at least one helical delivery lumen connected to receive an injectable substance from the delivery lumen of the catheter body. 1. A method of forming a helical needle , the method comprising:(a) wrapping a distal portion of a hypotube onto a mandrel, the wrapped distal portion of the hypotube being in a helical configuration about a central axis of the helical distal portion when wrapped onto the mandrel;(b) cutting a primary facet at the distal end of the helical distal portion;(c) cutting at least one secondary facet at the distal end of the helical distal portion; and(d) forming a tail portion proximal to the helical distal portion.2. The method of wherein the tail axis is offset from the center axis of the helical distal portion.3. The method of wherein the primary face is substantially perpendicular to a plane coincident with the central plane of the catheter shaft.4. The method of claim 1 , further comprising cutting a side hole into the hypotube.5. The method of claim 1 , wherein the hypotube is formed of stainless steel claim 1 , gallium claim 1 , or both.6. The method of claim 1 , wherein the hypotube has a gauge of 23 to 32.7. The method of claim 1 , wherein the primary facet is formed perpendicular to a plane coincident with ...

DEVICE AND METHOD FOR TRANSSEPTAL PUNCTURE

The present invention provides transseptal puncture devices configured to access structures on the left side of the heart from the right side of the heart without requiring open-heart surgery. The devices have adjustable stiffness to enter the vasculature in a flexible, atraumatic fashion, then become rigid once in place to provide a stable platform for penetration of the fossa ovalis. The devices are further configured to controllably and stably extend a needle to puncture the FO. The devices include an indwelling blunt stylus that can extend perpendicularly from the device to increase the accuracy of placement near the fossa ovalis. 123-. (canceled)24. A method , comprising:with a deflectable stylus disposed within a right atrium of a heart, extending an atraumatic support (1) having an end effector at its distal end, and (2) that is disposed at least partially within the stylus, distally from a distal end portion of the stylus such that the end effector contacts the septum; andwith the end effector in contact with the septum, extending a puncture member that is slidably disposed within the atraumatic support distally from the end effector such that the puncture member pierces the septum.25. The method of claim 24 , wherein the stylus is coupled to a shaft claim 24 , the method further comprising:inserting the shaft into the heart such that a distal end portion of the stylus is disposed in the right atrium of the heart; anddeflecting the stylus such that the distal end portion of the stylus points towards the septum of the heart.26. The method of claim 25 , wherein the extending the puncture member distally from the atraumatic support includes extending the puncture member distally along a longitudinal axis that is substantially perpendicular to a longitudinal axis of the shaft.27. The method of claim 25 , further comprising:visualizing from outside the patient a radiopaque or echo-bright marker that is disposed at the shaft, the atraumatic support, the end ...

TRANSSEPTAL PUNCTURE APPARATUS AND METHOD FOR USING THE SAME

Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure. 1. A transseptal instrument for accessing a cardiac septal wall within a heart comprising:a flexible introducer having an interior lumen, a distal curve, and a distal taper; anda cannula having an interior lumen with an inner diameter, a distal curve, and a distal blunt end, the cannula being telescopically disposed into the flexible introducer;where the flexible introducer has insufficient columnar strength and unsuitable shape for accessing a predetermined location on the cardiac septal wall when the cannula is not disposed within the interior lumen of the introducer and in close proximity to the distal taper thereof, but is able to access the predetermined location on the cardiac septal wall when the cannula is disposed within the interior lumen of the introducer and in lose proximity to the distal taper thereof.2. The transseptal instrument of where the flexible introducer comprises a blunt end outer sheath and a tapered blunt end dilator telescopically disposed in the outer sheath.3. The transseptal instrument of further comprising a proximal hub claim 1 , a valve included within the hub; and where the cannula is coupled to the proximal hub and valve.4. The transseptal instrument of where the cannula is composed of metal claim 1 , polymer claim 1 , composite claim 1 , or glass claim 1 , though ...

Devices, systems, and methods for delivering a substance within a mammalian luminal organ or area adjacent thereto

Devices, systems, and methods for delivering a substance within a mammalian luminal organ or area adjacent thereto. In at least one exemplary embodiment of a system of the present disclosure, the system comprises an inner delivery device, comprising an inner portion configured to receive a substance therein, a pock tip at or near a distal end of the inner delivery device, the pock tip configured to deliver the substance from the inner portion, through a pock tip aperture defined within the pock tip, and into a mammalian tissue and/or luminal organ, and an embolus positioned within the inner portion, the embolus configured so that the substance remains distal to the embolus when the substance is positioned within the inner portion.

APPARATUS AND METHOD FOR SEPTAL PUNCH

In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum. 1. A method , comprising:inserting a shaft having a guide attached thereto via a guide coupler into a heart of a patient such that (1) the shaft spans an inferior vena cava (IVC) of the heart and a superior vena cava (SVC) of the heart, and (2) a distal end of the guide is disposed in the right atrium of the heart;with the shaft spanning the IVC and SVC and the distal end of the guide disposed in the right atrium, deflecting the distal end of the guide about the guide coupler such that the distal end of the guide points towards a septum of the heart;extending an elongate member that is disposed within the guide distally from the guide and towards the septum, the elongate member having an end effector extending from its distal end, the extending the elongate member including tenting a target puncture site of the septum with the end effector; andwith the target puncture site tented by the end effector, extending a septum penetrator that is slidably disposed within the elongate member distally from the elongate member such that the septum penetrator pierces the septum at the target puncture site.2. The method of claim 1 ,wherein the inserting the ...

Methods and Devices for Puncturing Tissue

Novel and unique medical devices and associated methods are disclosed, for facilitating efficient and repeatable puncture of a tissue site while allowing vascular access from various access sites of a patient's body. Disclosed medical devices include dilators and wires usable alone or in combination and configured to facilitate tissue access and puncture at various anatomical locations from desired access sites. The medical devices each include one or more sections having sufficient flexibility for accessing the tissue site from the access site while retaining sufficient stiffness to perform one or more additional functions. 1. A medical device for puncturing tissue at a tissue site , the medical device comprising:an elongate member having a proximal section, a distal section and a rail section between the proximal and distal sections; andan active tip at a distal end of the distal section, the active tip operable to deliver energy to create a puncture through the tissue;the rail section being configured to both act as a rail for supporting installation of one or more tubular members thereupon as well as to be maneuverable for enabling access to the tissue site.2. The medical device of claim 1 , wherein the rail section is operable to bend at least 180 degrees for enabling access to the tissue site.3. The medical device of claim 2 , wherein a stiffness of the rail section is between about 150 N/m and about 600 N/m to enable the rail section to be bendable by at least 180 degrees and to function as a rail for supporting installation of one or more tubular members thereupon.4. The medical device of any one of - claim 2 , wherein the rail section has a length of between about 700 mm to about 1750 mm to enable access to the tissue site.5. The medical device of claim 4 , wherein the rail section has a length of between about 1200 mm to about 1300 mm.6. The medical device of claim 1 , wherein the distal section defines a distal section curved portion configured to ...

TRANSSEPTAL GUIDE WIRE PUNCTURE SYSTEM

A trans-atrial septal catheter system for delivery of a steerable sheath into the left atrium contains three components. The first component is a three-segmented needle-guide wire composed of a distal needle designed to flex sharply in relation to the conjoined looped guide wire segment after fossa ovalis puncture and needle advancement. The distal guide wire loops are advanced into the left atrium maintaining the angled needle in a central location relevant to the loops for preserving an atraumatic position while stabilizing the loops in the left atrium. The elongated proximal extra stiff guide wire segment is conjoined to the looped segment which crosses the fossa ovalis and extends proximally to become externalized to the femoral vein. This segment is extra stiff and significantly elongated to permit catheter and device exchanges. The guide wire serves as a support rail over which the dilator and sheath can be advanced into the left atrium. This transseptal system is uniquely forward looking and permits cautious and iterative delivery of the dilator into the fossa ovalis for “tenting” by way of a proximal sheath activator that interacts with the dilator. The proximal externalized GW is then advanced to permit puncture of the fossa ovalis. After puncturing a precise location of the fossa ovalis, the needle and coiled guide wire loops are further advanced into the left atrium. With the proximal activator, the dilator is advanced across the fossa ovalis into the left atrium using single-handed maneuvering for separate dilator advancement and steering of the sheath by way of turning or actuating the sheath handle. 1. A transseptal guide wire , comprising a proximal end , a distal end and a middle segment ,a. wherein the distal end comprises a transseptal needle attached to the guide wire distal end and positioned in continuity with the distal end of the guide wire;b. wherein the middle segment is formed of a shape memory material to form at least one looped segment; ...

HOLLOW PLUG

A mounting element defining a bore, the mounting element being configured to mount to an exterior surface of an organ of a patient. A one way valve sized to be received and retained within the bore of the mounting element is included, the one way valve having an open position and a closed position. The one way valve substantially occludes the bore when the valve is in the closed position. The one way valve is biased in the closed position. A plug having a lumen extending there through is included, the plug being configured to be releasably inserted through at least a portion of the one way valve. The plug is configured to transition the one way valve from the closed position to the open position and to maintain the one way valve in the open position when the plug is inserted within the bore. 1. A mounting kit , comprising:a mounting element defining a bore, the mounting element being configured to mount to an exterior surface of an organ of a patient;a one way valve sized to be received and retained within the bore of the mounting element, the one way valve having an open position and a closed position, the one way valve substantially occluding the bore when the valve is in the closed position, the one way valve being biased in the closed position; anda plug having a lumen extending there through, the plug being configured to be releasably inserted through at least a portion of the one way valve, the plug being configured to transition the one way valve from the closed position to the open position and to maintain the one way valve in the open position when the plug is inserted within the bore.2. The mounting kit of claim 1 , wherein the plug has a flange configured to provide for a maximum depth insertion of the plug within the bore.3. The mounting kit of claim 1 , wherein the one way valve is one from the group consisting of a tri-leaflet valve claim 1 , flap valve claim 1 , butterfly valve claim 1 , and duckbill valve.4. The mounting kit of claim 1 , wherein the ...

DEVICE, SYSTEM AND METHOD FOR PERICARDIAL ACCESS

Device for accessing a pericardial space of a subject in need thereof, the device including a tubular member having an atraumatic distal end and a thread formed on, and at least partially around, the outer surface of the tubular member, proximally to the distal end; wherein the thread is configured to cut, puncture and/or penetrate a pericardium. 137.-. (canceled)38. A device for accessing a pericardial space of a subject in need thereof , the device comprising:a tubular member having an open ended atraumatic distal end, a proximal end, and a wall having an outer surface and an inner surface forming a lumen; anda thread formed on, and at least partially around, said outer surface, proximal to said atraumatic distal end, wherein said thread comprises a sharp distal tip,wherein said thread is configured to cut, puncture and/or penetrate a pericardium, when in use, at an essentially perpendicular and/or tangential angle relative to said longitudinal axis of said tubular member, andwherein the atraumatic distal end is configured to protect said subject's heart and/or myocardium from being damaged.39. The device according to claim 38 , further comprising at least one sensor configured to detect penetration of said device into said pericardial space.40. The device according to claim 39 , wherein said sensor is selected from a bio-impedance sensor and a pressure sensor.41. The device according to claim 39 , wherein the at least one sensor is positioned on said atraumatic distal end and/or on said thread.42. The device according to claim 38 , wherein the proximal end of said tubular member comprises an attachment mechanism configured to reversibly attach said tubular member to a handle.43. The device according to claim 42 , wherein the proximal end of said tubular member comprises a securing element configured to ensure proper connection of said tubular member to said handle.44. The device according to claim 38 , wherein said tubular member is open ended claim 38 , thereby ...

DEVICES, SYSTEMS, AND METHODS FOR DELIVERING A SUBSTANCE WITHIN A MAMMALIAN LUMINAL ORGAN OR AREA ADJACENT THERETO

Devices, systems, and methods for delivering a substance within a mammalian luminal organ or area adjacent thereto. In at least one exemplary embodiment of a system of the present disclosure, the system comprises an inner delivery device, comprising an inner portion configured to receive a substance therein, a pock tip at or near a distal end of the inner delivery device, the pock tip configured to deliver the substance from the inner portion, through a pock tip aperture defined within the pock tip, and into a mammalian tissue and/or luminal organ, and an embolus positioned within the inner portion, the embolus configured so that the substance remains distal to the embolus when the substance is positioned within the inner portion. In another embodiment, the system further comprises an outer catheter, comprising an elongate body, a guidewire lumen defined within the elongate body and configured to receive at least part of a guidewire therein, and a central lumen defined within the elongate body, the central lumen configured to receive at least a portion of the inner delivery device. 1. An inner delivery device , comprising:an inner portion configured to receive a substance therein; anda tapered pock tip forming a distal end of the inner delivery device, the pock tip configured to deliver the substance from the inner portion, through a pock tip aperture defined within the pock tip, and into a mammalian tissue and/or luminal organ.2. The inner delivery device of claim 1 , further comprising:an embolus positioned within the inner portion, the embolus configured so that the substance remains distal to the embolus when the substance is positioned within the inner portion.3. The inner delivery device of claim 2 , further comprising:a delivery shaft positioned proximal to the embolus, the delivery shaft configured to fit within the inner delivery device and facilitate delivery of the substance by way of distal advancement of the embolus within the inner delivery device.4. ...

SYSTEM AND METHOD FOR TREATING CONNECTIVE TISSUE

A method and system of treating connective tissue to increase flexibility of the connective tissue or decrease tension in the connective tissue includes forming perforations in the connective tissue to at least 90% of the depth or thickness of the connective tissue and maintaining the perforations in the connective tissue. The method alters the tissue to enhance the fundamental mechanisms involved the immunology, biochemistry, and molecular genetics of the metabolism of the connective tissue. 1. A method of treating connective tissue comprising:forming a two-dimensional array of pores in the connective tissue to at least 90% of the depth of the connective tissue; andat least partially affecting normal healing of the perforations;wherein the pores are arrayed according to rows and columns; andwherein the pores are arranged in a polygonal shape.2. The method of claim 1 , wherein the connective tissue is ear tissue.3. The method of claim 1 , wherein the connective tissue is kidney tissue.4. The method of claim 1 , wherein the connective tissue is ovary tissue.5. The method of claim 1 , wherein the connective tissue is aponeurose tissue.6. The method of claim 1 , wherein the connective tissue is neural sheath tissue.7. The method of claim 1 , wherein the connective tissue is bone.8. The method of claim 1 , wherein the connective tissue is cartilage.9. The method of claim 1 , wherein the connective tissue is ligament.10. The method of claim 1 , wherein the connective tissue is tendon.11. The method of claim 1 , wherein the connective tissue is dura mater.12. The method of claim 1 , wherein the connective tissue is lymph node tissue.13. The method of claim 1 , wherein the connective tissue is spleen tissue.14. The method of claim 1 , wherein the connective tissue is vascular vessel tissue.15. The method of claim 1 , wherein the connective tissue is heart tissue.16. The method of claim 1 , wherein the connective tissue is muscle tissue.17. The method of claim 1 , wherein ...

Methods and devices for intra-atrial shunts having selectable flow rates

Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. The devices are adapted to permit fluid flow across the membrane in which the device is implanted at first rate, and at a second rate, wherein a difference between the first rate and the second rate is not solely dependent upon variations in blood pressure differential across the membrane due to the heart's pumping cycle.

METHOD AND CATHETER FOR CREATING AN INTERATRIAL APERTURE

A catheter device with a cutting structure or means on the distal portion is disclosed, along with a medical procedure for using the device. The catheter is configured in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue. 1. A medical device assembly comprising: a catheter shaft, the catheter shaft having a central lumen and a radiopaque marker,', 'a blade cutting edge that is oriented at a substantially right angle to the longitudinal axis of the catheter,', 'a shaped blade, the shaped blade comprising, 'a proximal tissue retention device,', 'a distal tissue retention device,, 'a catheter assembly, the catheter assembly comprisingan actuator, the actuator configured to reduce a gap between the proximal and distal tissue retention devices; anda first steering element configured to orient the shaped blade toward a tissue.2. The medical device of claim 1 , further comprising a locking mechanism configured to hold a force on the tissue between the proximal and distal tissue retention devices.3. The medical device of claim 1 , wherein the first steering element comprises a pull wire.4. The medical device of claim 1 , wherein the first steering element comprises a shape memory material or a preformed bend.5. The medical device of claim 1 , further comprising: a lumen, the lumen configured to contain the catheter inside the sheath,', 'an elongated sheath shaft, the sheath shaft having a first bend region, a central lumen and a distal end, and', 'wherein the first steering element is on the sheath, and is configured to move the first bend region from a substantially linear orientation to a second orientation substantially perpendicular to a longitudinal axis of the sheath., 'a sheath, the sheath comprising6. The medical device of claim 1 , wherein the actuator forces the proximal and distal tissue retention devices together with a preset force.7. The medical device of claim 1 , ...