Endolumenal stent-graft with leak-resistant seal

Implant deployment apparatus

Implant deployment apparatus

A delivery system including a restraining member maintains a collapsed implant in its collapsed state for delivery through a small passageway to a desired site in a mammalian body. Once the implant is positioned at the desired site, the restraining member is released so that the stent may expand or be expanded to its expanded state. In a preferred embodiment, the restraining member comprises a sheet of material that surrounds at least a portion of the collapsed stent. Portions of the restraining member are releasably coupled to one another with a low profile thread-like member or suture.

Kink resistant bifurcated prosthesis

The invention relates to an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Kink resistant bifurcated prosthesis

Endolumenal stent-graft with leak-resistant seal

Implant deployment apparatus

Kink resistant stent-graft

A stent-graft including a stent member having an inner surface and an outer surface, a generally tubular graft member and a coupling member that couples the stent member to the graft member. The coupling member, which is the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member and secures the stent member and graft member to one another. Alternatively, the coupling member can be described as interconnecting less than entirely the inner or outer surface of the graft member to the stent member. With this construction, regions of the stent member do not interfere with the coupling member. Shear stresses between the stent member and the coupling member and the risk of tearing the graft or coupling member or delamination therebetween may be reduced as compared to a fully enveloped stent member. This construction also provides improved flexibility and kink resistance.

Kink resistant bifurcated prosthesis

Implant deployment apparatus

A delivery system including a restraining member maintains a collapsed implant in its collapsed state for delivery through a small passageway to a desired site in a mammalian body. Once the implant is positioned at the desired site, the restraining member is released so that the stent may expand or be expanded to its expanded state. In a preferred embodiment, the restraining member comprises a sheet of material that surrounds at least a portion of the collapsed stent. Portions of the restraining member are releasably coupled to one another with a low profile thread-like member or suture.

MULTI-CATHETER STEERABLE GUIDING SYSTEM AND METHODS OF USE

Devices, systems, methods and kits are provided for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by a multi-catheter guiding system which is positioned in a desired configuration, generally directed toward the target tissue. Interventional devices may then be passed through the guiding system to the target tissue. Depending on the location of the target tissue and the desired angle of approach, the guiding system may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. The multi-catheter guiding system of the present invention comprises an outer guiding catheter and a coaxially positioned inner guiding catheter, each of which independently form curvatures so that together the curves properly direct the interventional device.

Device and method for variable blood flow occlusion

A blood flow control device having a catheter adapted to be advanced into a blood vessel to a blood flow control site within the blood vessel; an expandable anchor supported by the catheter, the expandable anchor being adapted to expand to engage a wall of the blood vessel, the expandable anchor having a blood impermeable wall defining an adjustable blood flow path extending through the expandable anchor from a proximal opening to a distal opening, the catheter being disposed outside of the adjustable blood flow path; a flow control element supported by the catheter, the flow control element being adapted to change a dimension of the adjustable blood flow path to change a rate of blood flow through the blood flow path; and a blood flow control actuator disposed at a proximal section of the catheter and adapted to actuate the flow control element.

Kink resistant stent-graft

A stent-graft including a stent member having an inner surface and an outer surface, a generally tubular graft member and a coupling member that couples the stent member to the graft member. The coupling member, which is the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member and secures the stent member and graft member to one another. Alternatively, the coupling member can be described as interconnecting less than entirely the inner or outer surface of the graft member to the stent member. With this construction, regions of the stent member do not interfere with the coupling member. Shear stresses between the stent member and the coupling member and the risk of tearing the graft or coupling member or delamination therebetween may be reduced as compared to a fully enveloped stent member. This construction also provides improved flexibility and kink resistance.

Method of making a kink resistant stent-graft

A stent-graft including a stent member having an inner surface and an outer surface, a generally tubular graft member and a coupling member that couples the stent member to the graft member. The coupling member, which is the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member and secures the stent member and graft member to one another. Alternatively, the coupling member can be to described as interconnecting less than entirely the inner or outer surface of the graft member to the stent member. With this construction, regions of the stent member do not interfere with the coupling member. Shear stresses between the stent member and the coupling member and the risk of tearing the graft or coupling member or delamination therebetween may be reduced as compared to a fully enveloped stent member. This construction also provides improved flexibility and kink resistance.

Delivery system for mitral valve leaflet apposition device

A delivery system for an interventional device includes an elongate catheter body, a catheter shaft extending within the elongate catheter body and configured to releasably attach to the interventional device, and at least one flexible element attached to a distal portion of the catheter shaft. The at least one flexible element has an expanded configuration in which the at least one flexible element extends beyond an outer circumference of the elongate catheter body and a collapsed configuration in which the at least one flexible element collapses within an inner circumference of the elongate catheter body. The at least one flexible element is configured to act as a tactile stop when pulled proximally against the elongate catheter body and/or to fold over the interventional device to act as a retraction aid.

Kink resistant stent-graft

A stent-graft including a stent member having an inner surface and an outer surface, a generally tubular graft member and a coupling member that couples the stent member to the graft member. The coupling member, which is the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member and secures the stent member and graft member to one another. Alternatively, the coupling member can be described as interconnecting less than entirely the inner or outer surface of the graft member to the stent member. With this construction, regions of the stent member do not interfere with the coupling member. Shear stresses between the stent member and the coupling member and the risk of tearing the graft or coupling member or delamination therebetween may be reduced as compared to a fully enveloped stent member. This construction also provides improved flexibility and kink resistance.

Methods, systems and devices for cardiac valve repair

Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

IMPLANT DEPLOYMENT APPARATUS

A delivery system including a restraining member maintains a collapsed implant in its collapsed state for delivery through a small passageway to a desired site in a mammalian body. Once the implant is positioned at the desired site, the restraining member is released so that the stent may expand or be expanded to its expanded state. In a preferred embodiment, the restraining member comprises a sheet of material that surrounds at least a portion of the collapsed stent. Portions of the restraining member are releasably coupled to one another with a low profile thread-like member or suture.

Multi-catheter steerable guiding system and methods of use

Devices, systems, methods and kits are provided for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by a multi-catheter guiding system which is positioned in a desired configuration, generally directed toward the target tissue. Interventional devices may then be passed through the guiding system to the target tissue. Depending on the location of the target tissue and the desired angle of approach, the guiding system may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. The multi-catheter guiding system of the present invention comprises an outer guiding catheter and a coaxially positioned inner guiding catheter, each of which independently form curvatures so that together the curves properly direct the interventional device.

Suture anchors and methods of use

The present invention provides apparatuses, systems, methods and kits for fastening sutures or similar devices used in medical surgical procedures. In particular, the present invention is suitable for use with percutaneous or minimally invasive procedures in which sutures are placed with catheter-based devices wherein the tying of knots is particularly challenging. Suture fasteners of the present invention provide for fastening the sutures together in a fixed position at any location along the suture strands. In addition, the fasteners are adjustable to allow repositioning of the fastener after placement to a new desired location along the suture strands. Similarly, such fasteners may be used to hold a single suture strand for various applications.

Device for renal decongestion

Methods and apparatuses for pumping blood within a blood vessel are described. The methods and apparatuses can be used for renal decongestion by pumping blood through the kidney(s), thereby increasing a pressure gradient across the kidney(s). The apparatuses can include one or more inflatable elements that can be repeatedly inflated and deflated to cause a pumping action within the blood vessel. In some embodiments, the one or more inflatable elements are positioned within one or more stents.

Kink resistant bifurcated prosthesis

The invention consists of an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Steerable access sheath and methods of use

The present invention provides devices, systems, methods and kits for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by an access sheath which is positioned in a desired configuration, generally directed toward the target tissue. Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. In addition, the access sheath has a locking feature to hold the sheath in place and maintain the desired configuration. Interventional devices may then be passed through the sheath to the target tissue.

Methods and devices for tissue grasping and assessment

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Kink-resistant bifurcated prosthesis

The invention consists of an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Suture fasteners and methods of use

The present invention provides apparatuses, systems, methods and kits for fastening sutures or similar devices used in medical surgical procedures. In particular, the present invention is suitable for use with percutaneous or minimally invasive procedures in which sutures are placed with catheter-based devices wherein the tying of knots is particularly challenging. Suture fasteners of the present invention provide for fastening the sutures together in a fixed position at any location along the suture strands. In addition, the fasteners are adjustable to allow repositioning of the fastener after placement to a new desired location along the suture strands. Similarly, such fasteners may be used to hold a single suture strand for various applications.

Kink-resistant bifurcated prosthesis

The invention consists of an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Kink resistant stent-graft

A stent-graft including a stent member having an inner surface and an outer surface, a generally tubular graft member and a coupling member that couples the stent member to the graft member. The coupling member, which is the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member and secures the stent member and graft member to one another. Alternatively, the coupling member can be described as interconnecting less than entirely the inner or outer surface of the graft member to the stent member. With this construction, regions of the stent member do not interfere with the coupling member. Shear stresses between the stent member and the coupling member and the risk of tearing the graft or coupling member or delamination therebetween may be reduced as compared to a fully enveloped stent member. This construction also provides improved flexibility and kink resistance.

KINK RESISTANT BIFURCATED PROSTHESIS

The invention relates to an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Methods and devices for capturing and fixing leaflets in valve repair

The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

Methods and devices for capturing and fixing leaflets in valve repair

The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

Kink-resistant bifurcated prosthesis

The invention consists of an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

METHODS, SYSTEMS AND DEVICES FOR CARDIAC VALVE REPAIR

Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart. 1. A chordal replacement device comprising:a proximal anchor comprising a flexible patch and a leaflet attachment device, wherein the flexible patch is affixed to an upper surface of a portion of a flailing leaflet with the leaflet attachment device;a distal anchor extending and affixed to a distal attachment site in a ventricle; anda flexible tether coupled to and tensioned between the proximal and distal anchors.2. The device of claim 1 , wherein the leaflet attachment device comprises a pair of expandable elements interconnected by a central attachment rod.3. The device of claim 2 , wherein the pair of expandable elements sandwich the flexible patch and the leaflet.4. The device of claim 1 , wherein the leaflet attachment device comprises an expandable element.5. The device of claim 1 , wherein the expandable element is self-deploying.6. The device of claim 5 , wherein the expandable element comprises a star-shaped barb claim 5 , a mesh web claim 5 , or a mesh ball.7. The device of claim 1 , wherein the proximal anchor further comprises a mesh stent deployable within an atrium.8. The device of claim 7 , wherein the mesh stent is coupled to a flexible rod that extends through a valve commissure into the ventricle.9. The device of claim 8 , wherein a distal end of the flexible rod couples to the distal anchor and ...

METHODS, SYSTEMS AND DEVICES FOR CARDIAC VALVE REPAIR

Disclosed are devices and methods for treating regurgitation through a valve in the heart. The devices can include an expandable, fluid-tight bladder configured to be deployed between valve leaflets of the heart valve. The bladder can include an upper portion that extends into the atrium of the heart; a lower portion that extends into the ventricle of the heart; and a middle portion positionable within the line of valve leaflet coaptation that provides a sealing surface for one or more of the leaflets. 1. A method for treating regurgitation through a valve in a heart , the heart having an atrium fluidically coupled to a ventricle by the valve , the valve including at least two leaflets which coapt along a line of coaptation , the method comprising:introducing percutaneously a medical device system into a patient's heart to a vicinity of a gap within the line of coaptation of the valve, the medical device system comprising: a steerable guide catheter configured for delivery through the patient's vasculature to the vicinity of the gap; a retractable sheath moveably disposed over a device comprising a frame sized to fit within a heart chamber and a pair of arms moveably coupled to the frame, the arms are structurally configured to move from a fluid flow-blocking position during a systole to a fluid flow-allowing position during a diastole in response to pressure changes occurring between the systole and the dystole;using the guide catheter to position the device within the gap along the line of coaptation;retracting the sheath to release the blocker from compressive forces maintaining the device in the delivery configuration;expanding the device after positioning the device along the line of coaptation; andretracting the catheter and the sheath from the heart.2. The method of claim 1 , wherein the frame further comprises a stationary portion coupled to a proximal portion of the pair of arms claim 1 , wherein the stationary portion is positioned above the level of the ...

METHODS AND DEVICES FOR TISSUE GRASPING AND ASSESSMENT

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation. 1. A method comprising:advancing a minimally invasive device into a chamber of a heart having a valve with valve leaflets, wherein the chamber comprises the left atrium and the valve comprises the mitral valve, and wherein the device comprises a stabilizer;temporarily stabilizing the valve leaflets by reducing movement of the valve leaflets by positioning the stabilizer against the ventricular side of the leaflets so as to reduce flail of the leaflets,wherein temporarily stabilizing the valve leaflets comprises temporarily slowing the natural pace of the heart with a pacing instrument member against the chordae.2. A method as in claim 1 , wherein the stabilizer comprises an expandable member claim 1 , a flap or at least one loop.3. A method as in claim 1 , wherein the device includes at least one loop claim 1 , and wherein temporarily stabilizing comprises positioning the at least one loop against the leaflets so as to reduce movement of the leaflets.4. A method as in claim 3 , wherein temporarily stabilizing further comprises moving the at least one loop along the leaflets toward the center of the valve so as to reduce movement of the leaflets.5. A method as in claim 1 , wherein the chamber comprises a ventricle including chordae extending from the ventricle to the valve leaflets claim 1 , and wherein temporarily stabilizing comprises holding the chordae with the device so as to reduce movement of the valve leaflets.6. A method as in claim 5 , wherein the device includes an expandable member and wherein holding the chordae comprises expanding the expandable member against the chordae. The present application is a continuation of U.S. patent application Ser. No. 13/239, ...

METHODS AND DEVICES FOR CAPTURING AND FIXING LEAFLETS IN VALVE REPAIR

The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation. 1. A method for repairing a cardiac valve having valve leaflets , the method comprising:advancing a catheter having a capture device through an atrium of the heart to a location near the cardiac valve, wherein the capture device comprises at least one proximal element and at least one distal element adapted to protrude radially outward;holding the at least one proximal element upward by a suture;extending the at least one distal element radially outward after advancing the capture device to the location near the cardiac valve of the heart;atraumatically positioning the at least one distal element against at least one leaflet of the cardiac valve;releasing the at least one proximal element by slacking the suture to allow the at least one proximal element to extend radially outward to capture the at least one leaflet between the at least one proximal element and the at least one distal element; anddetaching the capture device from the catheter.2. The method of claim 1 , wherein advancing the catheter comprises advancing the catheter through the inferior vena cava or the superior vena cava to the atrium of the heart.3. The method of claim 2 , wherein advancing the catheter further comprises advancing the catheter across an interatrial septum.4. The method of claim 1 , wherein advancing the catheter across an interatrial septum ...

STEERABLE ASSEMBLY FOR SURGICAL CATHETER

A catheter configured for intraluminal delivery to a location in the body of a patient, the catheter comprising a steerable assembly comprising a first segment connected to a second segment; the first segment comprises first and second cylindrical elements connected to each other by a first revolute joint in a first single plane; the second segment comprises third and fourth cylindrical elements connected to each other by a second revolute joint in a second single plane, wherein the first single plane and the second single plane are offset by an angle from each other. 1. A catheter configured for intraluminal delivery to a location in the body of a patient , the catheter comprising:an elongate hollow tubular body having a proximal end and a distal end; the steerable assembly comprises a first segment connected to a second segment;', 'the first segment comprises first and second elements each element defining an internal bore and connected to each other by a first revolute joint configured to bend in a first single plane, the first revolute joint being a bearing joint;', 'the second segment comprises third and fourth elements each element defining an internal bore and connected to each other by a second revolute joint configured to bend in a second single plane, the second revolute joint being a bearing joint;', 'wherein the first single plane and the second single plane are offset by an angle from each other., 'a steerable assembly attached to the distal end of the tubular body; wherein'}2. The catheter of claim 1 , wherein the first segment further comprises:a fifth element defining an internal bore, and connected to the second element by a third revolute joint configured to bend in the first single plane, the third revolute joint being a bearing joint;a sixth element defining an internal bore, and connected to the fourth element by a fourth revolute joint configured to bend in the second single plane, the fourth revolute joint being a bearing joint.3. The catheter ...

DEVICE AND METHOD FOR VARIABLE BLOOD FLOW OCCLUSION

A blood flow control device having a catheter adapted to be advanced into a blood vessel to a blood flow control site within the blood vessel; an expandable anchor supported by the catheter, the expandable anchor being adapted to expand to engage a wall of the blood vessel, the expandable anchor having a blood impermeable wall defining an adjustable blood flow path extending through the expandable anchor from a proximal opening to a distal opening, the catheter being disposed outside of the adjustable blood flow path; a flow control element supported by the catheter, the flow control element being adapted to change a dimension of the adjustable blood flow path to change a rate of blood flow through the blood flow path; and a blood flow control actuator disposed at a proximal section of the catheter and adapted to actuate the flow control element. 1. A blood flow control device comprising:a catheter adapted to be advanced into a blood vessel to a blood flow control site within the blood vessel;an expandable anchor supported by the catheter, the expandable anchor being adapted to expand to engage a wall of the blood vessel, the expandable anchor comprising a blood impermeable wall defining an adjustable blood flow path extending through the expandable anchor from a proximal opening to a distal opening, the catheter being disposed outside of the adjustable blood flow path;a flow control element supported by the catheter, the flow control element being adapted to change a dimension of the adjustable blood flow path to change a rate of blood flow through the blood flow path; anda blood flow control actuator disposed at a proximal section of the catheter and adapted to actuate the flow control element.2. The blood flow control device of claim 1 , wherein the flow control element is adapted to change a shape of the adjustable blood flow path.3. The blood flow control device of claim 1 , wherein the flow control element is adapted to change a shape of the expandable anchor. ...

DELIVERY SYSTEM FOR MITRAL VALVE LEAFLET APPOSITION DEVICE

A delivery system for an interventional device includes an elongate catheter body, a catheter shaft extending within the elongate catheter body and configured to releasably attach to the interventional device, and at least one flexible element attached to a distal portion of the catheter shaft. The at least one flexible element has an expanded configuration in which the at least one flexible element extends beyond an outer circumference of the elongate catheter body and a collapsed configuration in which the at least one flexible element collapses within an inner circumference of the elongate catheter body. The at least one flexible element is configured to act as a tactile stop when pulled proximally against the elongate catheter body and/or to fold over the interventional device to act as a retraction aid. 1. A delivery system for an interventional device comprising:an elongate catheter body;a catheter shaft extending within the catheter body and configured to releasably attach to the interventional device; andat least one flexible element attached to a distal portion of the catheter shaft, the at least one flexible element having an expanded configuration in which the at least one flexible element extends beyond an outer circumference of the elongate catheter body and a collapsed configuration in which the at least one flexible element collapses within an inner circumference of the elongate catheter body;wherein the at least one flexible element in the expanded configuration is configured to provide a tactile stop when moved proximally relative to and against a distal end of the elongate catheter body with a first amount of force, and wherein the at least one flexible element is configured to collapse from the expanded configuration to the collapsed configuration to fit within the elongate catheter body when the at least one flexible element is moved relative to and against the distal end of the elongate catheter body with a second amount of force that is greater ...

METHODS AND DEVICES FOR TISSUE GRASPING AND ASSESSMENT

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation. 1. A method comprising:advancing a minimally invasive device into a chamber of a heart having a valve with valve leaflets, wherein the chamber comprises the left atrium and the valve comprises the mitral valve, and wherein the device comprises a stabilizer;temporarily stabilizing the valve leaflets by reducing movement of the valve leaflets by positioning the stabilizer against the ventricular side of the leaflets so as to reduce flail of the leaflets,wherein temporarily stabilizing the valve leaflets comprises temporarily slowing the natural pace of the heart with a pacing instrument member against the chordae.2. A method as in claim 1 , wherein the stabilizer comprises an expandable member claim 1 , a flap or at least one loop.3. A method as in claim 1 , wherein the device includes at least one loop claim 1 , and wherein temporarily stabilizing comprises positioning the at least one loop against the leaflets so as to reduce movement of the leaflets.4. A method as in claim 3 , wherein temporarily stabilizing further comprises moving the at least one loop along the leaflets toward the center of the valve so as to reduce movement of the leaflets.5. A method as in claim 1 , wherein the chamber comprises a ventricle including chordae extending from the ventricle to the valve leaflets claim 1 , and wherein temporarily stabilizing comprises holding the chordae with the device so as to reduce movement of the valve leaflets.6. A method as in claim 5 , wherein the device includes an expandable member and wherein holding the chordae comprises expanding the expandable member against the chordae. The present application is a continuation of U.S. patent application Ser. No. 14/070, ...

METHODS AND DEVICES FOR CAPTURING AND FIXING LEAFLETS IN VALVE REPAIR

The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation. 1. A device for repairing a cardiac valve , said device comprising:an interventional catheter adapted to pass from the remote vasculature of a patient to a position within a heart of the patient adjacent to the cardiac valve; anda capture device on the interventional catheter comprising at least one distal element coupled to the catheter, wherein the distal element is protrudable radially outward and is adapted to press against a downstream surface of at least one leaflet,wherein the capture device fixedly couples the valve leaflet to a second valve leaflet; anda pledget adjacent the distal element, the pledget adapted to obstruct blood flow through a gap created by the device along a coaptation line between the at least one leaflet and a second leaflet.2. The device of claim 1 , wherein the pledget is disk shaped.3. The device of claim 1 , further comprising at least one proximal element disposed proximal to the distal element.4. The device of claim 3 , wherein the proximal element is protrudable radially outward.5. The device of claim 3 , wherein the pledget is positioned between the proximal and distal elements.6. The device of claim 3 , wherein the at least one leaflet is captured between the proximal and distal elements.7. A device for repairing a cardiac valve claim 3 , said device comprising:an interventional catheter ...

Device for renal decongestion

Methods and apparatuses for pumping blood within a blood vessel are described. The methods and apparatuses are can be used for renal decongestion by pumping blood through the kidney(s), thereby increasing a pressure gradient across the kidney(s). The apparatuses can include one or more inflatable elements that can be repeatedly inflated and deflated to cause a pumping action within the blood vessel. In some embodiments, the one or more inflatable elements are positioned within one or more stents.

METHODS, SYSTEMS AND DEVICES FOR CARDIAC VALVE REPAIR

Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart. 1. A chordal replacement device comprising: a flexible patch; and', 'a leaflet attachment device,', 'wherein the flexible patch is affixed to an upper surface of a portion of a flailing leaflet with the leaflet attachment device;, 'a proximal anchor comprisinga distal anchor extending in a ventricle; anda flexible tether coupled to and tensioned between the proximal and distal anchors.2. The device of claim 1 , wherein the proximal anchor further comprises a mesh stent deployable within an atrium.3. The device of claim 2 , wherein the mesh stent is coupled to a flexible rod that extends through a valve commissure into the ventricle.4. The device of claim 3 , wherein a distal end of the flexible rod couples to the distal anchor and provides consistent tension on the tether during a heart cycle.5. The device of claim 3 , wherein the flexible rod has a deflectable claim 3 , spring-formed shape.6. The device of claim 3 , wherein the flexible rod is jointed.7. The device of claim 1 , wherein the distal anchor comprises a balloon and wherein infusion of fluid into the balloon increases tension on the tether. The present application is a divisional of U.S. patent application Ser. No. 13/852,459 (pending) filed Mar. 28, 2013, which is a divisional application of Ser. No. 12/883,095 filed Sep. 15, 2010 (abandoned), which ...

METHODS AND DEVICES FOR CAPTURING AND FIXING LEAFLETS IN VALVE REPAIR

The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation. 1. A capture device for fixation of leaflets of a cardiac valve comprising:at least one distal element adapted to be extended radially outward from a center of the capture device after the capture device is advanced to a location near the cardiac valve of the heart, the at least one distal element being configured to be atraumatically positioned against at least one leaflet of the cardiac valve; andat least one proximal element held proximally upward by a suture in a tensioned condition, wherein the at least one proximal element has a bias configured to extend radially outward from the center of the capture device when the suture is slacked towards a slacked condition to enable capture of the at least one leaflet between the at least one proximal element and the at least one distal element.2. The device of claim 1 , wherein the at least one distal element includes a pair of distal elements claim 1 , and the at least one proximal element includes a pair of proximal elements.3. The device of claim 1 , wherein the at least one distal element comprises a loop.4. The device of claim 1 , wherein the at least one distal element comprises a wire.5. The device of claim 1 , wherein the at least one distal element comprises a petal shape.6. The device of claim 1 , wherein the at least one proximal element is biased toward the at least one ...

METHODS, SYSTEMS AND DEVICES FOR CARDIAC VALVE REPAIR

Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart. 1. A method of attaching a chordal replacement device , the method comprising:advancing a proximal anchor into a heart;attaching a flexible patch of the proximal anchor to the heart;attaching a leaflet attachment device of the proximal anchor to the heart to an upper surface of a portion of a flailing leaflet;advancing a distal anchor of the chordal replacement device into a ventricle of the heart, the distal anchor including a balloon; and 'wherein a portion of the distal anchor is configured to extend only partially into a sidewall of the ventricle.', 'filling the balloon with fluid to increase tension on a flexible tether, which is coupled to and tensioned between the proximal and distal anchors,'}2. The method of claim 1 , wherein the proximal anchor further comprises a mesh stent deployable within an atrium.3. The method of claim 2 , wherein the mesh stent is coupled to a flexible rod that is configured to extend through a valve commissure and into the ventricle.4. The method of claim 3 , wherein a distal end of the flexible rod couples to the distal anchor and is configured to provide consistent tension on the tether during a heart cycle.5. The method of claim 3 , wherein the flexible rod has a deflectable claim 3 , spring-formed shape.6. The method of claim 3 , wherein the flexible rod is jointed. The ...

Methods and devices for tissue grasping and assessment

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

METHODS, SYSTEMS AND DEVICES FOR CARDIAC VALVE REPAIR

Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart. 1. A device for treating a heart valve , comprising:a first wedge-shaped element; andan anchor coupled to the first wedge-shaped element and configured to secure the first wedge-shaped element to heart tissue;wherein the first wedge-shaped element is configured to provide support to a lower surface of a first heart valve leaflet.2. The device of claim 1 , wherein the first wedge-shaped element comprises a contoured shape configured to provide the support to the lower surface of the first heart valve leaflet.3. The device of claim 1 , wherein the first wedge-shaped element is configured to be positioned below the first heart valve leaflet and a second heart valve leaflet.4. The device of claim 1 , wherein the first wedge-shaped element has a size configured to shift a line of coaptation of the heart valve.5. The device of claim 1 , wherein the first wedge-shaped element comprises an ungula-of-a-cylinder shape.6. The device of claim 1 , wherein the first wedge-shaped element comprises a cone shape.7. The device of claim 1 , wherein the first wedge-shaped element comprising a frustoconical shape.8. The device of claim 1 , further comprising a second wedge-shaped element.9. The device of claim 8 , wherein the second wedge-shaped element is configured to provide support to a lower surface of a second heart valve leaflet ...

Methods and devices for capturing and fixing leaflets in valve repair

The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

Implant deployment apparatus

Methods and devices for tissue grasping and assessment

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Steerable access sheath and methods of use

The present invention provides devices, systems, methods and kits for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by an access sheath which is positioned in a desired configuration, generally directed toward the target tissue. Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. In addition, the access sheath has a locking feature to hold the sheath in place and maintain the desired configuration. Interventional devices may then be passed through the sheath to the target tissue.

Detachment mechanism for implantable fixation devices

The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Kink resistant stent-graft

This invention is a stent graft (2) including a stem member (6) having an inner surface and an outer surface, a generally tubular graft member (4) and a coupling member (8) that couples the stent member (6) to the graft member (4). The coupling member (8), which in the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member (6) and secures the stent member (6) and graft member (4) to one another. Alternatively, the coupling member (8) can be described as interconnecting less than entirely the inner or outer surface of the graft member (4) to the stent member (6). With this construction, regions of the stent member (6) do not interface with the coupling member (8). Shear stresses between the stent member (6) and the coupling member (8) and the risk of tearing the graft (4) or coupling member (8) or delamination therebetween may be reduced as compared to a fully enveloped stent member (6). This construction also provides improved flexibility and kink resistance.

Kink resistant bifurcated prosthesis

The invention relates to an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stem or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stem-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Catheter shaft with an oblong transverse cross section

A balloon dilatation catheter having a catheter shaft (11) with an oblong transverse cross section with one transverse dimension in a direction perpendicular to the first direction. The first dimension is about 1.1 to about 3 times greater, preferably about 1.2 to about 2.5 times greater than the second dimension. In one embodiment, a length of the distal shaft section has inner (12) and outer (13) tubular members where about 30 % to not more than about 90 % of the inner periphery of the outer tubular member takes the shape of and is secured to the exterior of the inner tubular member. In another embodiment the flexible distal shaft section is an extruded section having an oval or elliptical transverse cross section. Preferably a pseudoelastic hypotube of NiTi alloy defines at least part of the inflation lumen within the catheter shaft. In another embodiment of the invention the proximal shaft of the catheter has an inner and outer tubular member.

Methods and devices for tissue grasping and assessment

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Methods, systems and devices for cardiac valve repair

Disclosed are devices and methods for treating regurgitation through a valve in the heart. The devices can include an expandable, fluid-tight bladder configured to be deployed between valve leaflets of the heart valve. The bladder can include an upper portion that extends into the atrium of the heart; a lower portion that extends into the ventricle of the heart; and a middle portion positionable within the line of valve leaflet coaptation that provides a sealing surface for one or more of the leaflets.

Twisted Torsion Resistant Prosthesis

Una prótesis endoluminal implantable, que comprende: un miembro (126; 126'; 782; 786) de stent que tiene una superficie externa, un miembro (124; 780; 784) de injerto; un primer miembro (128) de cinta que tiene una primera anchura y un segundo miembro (128) de cinta que tiene una segunda anchura distinta de dicha primera anchura, cubriendo dicho primer miembro (128) de cinta únicamente una porción de dicha superficie externa de dicho miembro (126; 126'; 782; 786) de stent y fijando el miembro (126; 126'; 782; 786) de stent y el miembro (124; 780; 784) de injerto entre sí, cubriendo dicho segundo miembro (128) de cinta únicamente una porción de dicha superficie externa de dicho miembro (126; 126'; 782; 786) de stent y fijando el miembro (126; 126'; 782; 786) de stent y el miembro (124; 780; 784) de injerto entre sí. An implantable endoluminal prosthesis, comprising: a stent member (126; 126 '; 782; 786) having an outer surface; a graft member (124; 780; 784); a first tape member (128) having a first width and a second tape member (128) having a second width other than said first width, said first tape member (128) covering only a portion of said outer surface of said stent member (126; 126 '; 782; 786) and fixing the stent member (126; 126'; 782; 786) and graft member (124; 780; 784) together, covering said second member ( 128) taping only a portion of said outer surface of said stent member (126; 126 '; 782; 786) and securing the stent member (126; 126'; 782; 786) and the stent member (124; 780; 784) graft each other.

Endolumenal stent-graft with leak-resistant seal

An implantable medical device has a tubular member and a sealing member secured to an outer surface of the tubular member. The tubular member is expandable to engage an endolumenal wall and has a lumen for providing an artificial conduit for flow through an endolumenal space defined by that wall. The seal member occludes flow around the tubular member between the outer surface and the endolumenal wall. One suitable tubular member for use in the present invention is a stent-graft which may be bifurcated for use in protecting vascular wall malformations adjacent to vascular bifurcations against endolumenal pressure and flow. The seal member may be a flange that is oriented on the outer surface at one end of the tubular member as a one-way valve against flow. Multiple seal members may be used, either on opposite ends of the tubular member or in series at one end therof. Where anchors are used to secure the tubular member to the endolumenal wall, the seal member is positioned to protect against flow through leakage paths formed at localized areas of deformation in the tubular wall adjacent to the anchors. One or more seal members may also be used with two or more tubular members to prevent flow through endolumenal spaces that remain open to flow due to gaps between the multiple, parallel tubular members.

Kink resistant bifurcated prosthesis

The invention relates to an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed m have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Kink resistant stent-graft

Devices for cardiac valve repair

Methods and devices for tissue grasping and assessment

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Endolumenal stent-graft with leak-resistant seal

An implantable medical device has a tubular member and a sealing member secured to an outer surface of the tubular member. The tubular member is expandable to engage an endolumenal wall and has a lumen for providing an artificial conduit for flow through an endolumenal space defined by that wall. The seal member occludes flow around the tubular member between the outer surface and the endolumenal wall. One suitable tubular member for use in the present invention is a stent-graft which may be bifurcated for use in protecting vascular wall malformations adjacent to vascular bifurcations against endolumenal pressure and flow. The seal member may be a flange that is oriented on the outer surface at one end of the tubular member as a one-way valve against flow. Multiple seal members may be used, either on opposite ends of the tubular member or in series at one end therof. Where anchors are used to secure the tubular member to the endolumenal wall, the seal member is positioned to protect against flow through leakage paths formed at localized areas of deformation in the tubular wall adjacent to the anchors. One or more seal members may also be used with two or more tubular members to prevent flow through endolumenal spaces that remain open to flow due to gaps between the multiple, parallel tubular members.

Kink resistant stent-graft

This invention is a stent graft (2) including a stent member (6) having an inner surface and an outer surface, a generally tubular graft member (4) and a coupling member (8) that couples the stent member (6) to the graft member (4). The coupling member (8), which in the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member (6) and secures the stent member (6) and graft member (4) to one another. Alternatively, the coupling member (8) can be described as interconnecting less than entirely the inner or outer surface of the graft member (4) to the stent member (6). With this construction, regions of the stem member (6) do not interface with the coupling member (8). Shear stresses between the stent member (6} and the coupling member (8) and the risk of tearing the graft (4) or coupling member (8) or delamination therebetween may he reduced as compared to a fully enveloped stent member (6). This construction also provides improved flexibility and kink resistance.

Kink resistant bifurcated prosthesis

The invention relates to an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed m have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

ENDOLUMINAL STENT FABRIC WITH LEAK RESISTANT SEAL

Catheter shaft with an oblong transverse cross section

A balloon dilatation catheter having a catheter shaft (11) with an oblong transverse cross section with one transverse dimension in a direction perpendicular to the first direction. The first dimension is about 1.1 to about 3 times greater, preferably about 1.2 to about 2.5 times greater than the second dimension. In one embodiment, a length of the distal shaft section has inner (12) and outer (13) tubular members where about 30 % to not more than about 90 % of the inner periphery of the outer tubular member takes the shape of and is secured to the exterior of the inner tubular member. In another embodiment the flexible distal shaft section is an extruded section having an oval or elliptical transverse cross section. Preferably a pseudoelastic hypotube of NiTi alloy defines at least part of the inflation lumen within the catheter shaft. In another embodiment of the invention the proximal shaft of the catheter has an inner and outer tubular member.

Implant deployment apparatus

A delivery system (100), including a restraining member (102), maintains a collapsed implant (106) in its collapsed state for delivery through a small passageway to a desired site in a mammalian body. Once the implant is positioned at the desired site, the restraining member is released so that the stent may expand or be expanded to its expanded state. In a preferred embodiment, the restraining member comprises a sheet of material that surrounds at least a portion of the collapsed stent. Portions of the restraining member are releasably coupled to one another with a low profile thread-like member or suture.

Method for producing a stent graft

Kink resistant stent-graft

This invention is a stent graft (2) including a stent member (6) having an inner surface and an outer surface, a generally tubular graft member (4) and a coupling member (8) that couples the stent member (6) to the graft member (4). The coupling member (8), which in the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member (6) and secures the stent member (6) and graft member (4) to one another. Alternatively, the coupling member (8) can be described as interconnecting less than entirely the inner or outer surface of the graft member (4) to the stent member (6). With this construction, regions of the stem member (6) do not interface with the coupling member (8). Shear stresses between the stent member (6} and the coupling member (8) and the risk of tearing the graft (4) or coupling member (8) or delamination therebetween may he reduced as compared to a fully enveloped stent member (6). This construction also provides improved flexibility and kink resistance.

Catheter with an expandable perfusion lumen

An intravascular catheter such as a dilatation catheter for angioplasty procedures which is provided with a perfusion lumen extending which is expanded when disposed within a desired location with the patient's body lumen so as to increase the perfusion of body fluid such as oxygenated blood through the perfusion lumen.

Kink resistant stent-graft

This invention is a stent graft (2) including a stent member (6) having an inner surface and an outer surface, a generally tubular graft member (4) and a coupling member (8) that couples the stent member (6) to the graft member (4). The coupling member (8), which in the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member (6) and secures the stent member (6) and graft member (4) to one another. Alternatively, the coupling member (8) can be described as interconnecting less than entirely the inner or outer surface of the graft member (4) to the stent member (6). With this construction, regions of the stent member (6) do not interface with the coupling member (8). Shear stresses between the stent member (6) and the coupling member (8) and the risk of tearing the graft (4) or coupling member (8) or delamination therebetween may be reduced as compared to a fully enveloped stent member (6). This construction also provides improved flexibility and kink resistance.

Low profile dilatation catheter

An intravascular catheter, such as a balloon dilatation catheter, which has at least a distal section (35) of an outer tubular member (31) conforms to the shape of and preferably is secured to an inner tubular member (36) over a significant portion there-of to provide a catheter shaft having small transverse dimensions and improved flexibility with little or no loss in pushability. The catheter construction can be employed in a wide variety of catheters.

Endolumenal stent-graft with leak-resistant seal

An implantable medical device has a tubular member and a sealing member secured to an outer surface of the tubular member. The tubular member is expandable to engage an endolumenal wall and has a lumen for providing an artificial conduit for flow through an endolumenal space defined by that wall. The seal member occludes flow around the tubular member between the outer surface and the endolumenal wall. One suitable tubular member for use in the present invention is a stent-graft which may be bifurcated for use in protecting vascular wall malformations adjacent to vascular bifurcations against endolumenal pressure and flow. The seal member may be a flange that is oriented on the outer surface at one end of the tubular member as a one-way valve against flow. Multiple seal members may be used, either on opposite ends of the tubular member or in series at one end therof. Where anchors are used to secure the tubular member to the endolumenal wall, the seal member is positioned to protect against flow through leakage paths formed at localized areas of deformation in the tubular wall adjacent to the anchors. One or more seal members may also be used with two or more tubular members to prevent flow through endolumenal spaces that remain open to flow due to gaps between the multiple, parallel tubular members.

Suture fasteners and methods of use

The present invention provides apparatuses, systems, methods and kits for fastening sutures or similar devices used in medical surgical procedures. In particular, the present invention is suitable for use with percutaneous or minimally invasive procedures in which sutures are placed with catheter-based devices wherein the tying of knots (108) is particularly challenging. Suture fasteners (102) of the present invention provide for fastening the fasteners, and the fasteners are adjustable to allow repositioning of the fastener after placement to a new desired location along the suture strands.

Device for cardiac valve repair

Disclosed are devices and methods for treating regurgitation through a valve in the heart. The devices can include an expandable, fluid-tight bladder configured to be deployed between valve leaflets of the heart valve. The bladder can include an upper portion that extends into the atrium of the heart; a lower portion that extends into the ventricle of the heart; and a middle portion positionable within the line of valve leaflet coaptation that provides a sealing surface for one or more of the leaflets.

DEVICES FOR TAKING AND FIXING SAILINGS IN FLAP REPARATION

Holding system for coiled intravascular products

This invention is directed to a member which is mounted on an elongated intraluminal device such as a catheter or a guidewire, preferably the proximal portion thereof, which releasably holds at least one turn of a coiled product. The coiled product may be the intraluminal device on which the fixture is mounted or it may be a separate product. In one embodiment of the invention, the turn holding member has a body and at least one flexible arm which holds a turn against the body of the fixture. In another embodiment of the invention, the holding member is a tubular element having a wall portion with a spirally shaped cutout through which a turn of coiled product can be advanced into the inner lumen or the tubular element.

Methods and devices for tissue grasping and assessment

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Methods, systems and devices for cardiac valve repair

Disclosed are devices and methods for treating regurgitation through a valve in the heart. The devices can include an expandable, fluid-tight bladder configured to be deployed between valve leaflets of the heart valve. The bladder can include an upper portion that extends into the atrium of the heart; a lower portion that extends into the ventricle of the heart; and a middle portion positionable within the line of valve leaflet coaptation that provides a sealing surface for one or more of the leaflets.

Dilatation catheter with a small cross-section

Implant deployment apparatus

Methods, systems and devices for cardiac valve repair

A chordal replacement device comprising: a proximal anchor (3910), a distal anchor (3915) extending and affixed to a distal attachment site in a ventricle; and a flexible tether (3920) coupled to and tensioned between the proximal and distal anchors, wherein the proximal anchor may comprise a flexible crimp clip having one or more barbs that embed into and affix to a portion of a leaflet (LF) or a flexible patch and a leaflet attachment device, wherein the flexible patch is affixed to an upper surface of a portion of a flailing leaflet with the leaflet attachment device. The proximal anchor may also comprise a mesh stent deployable within an atrium, wherein the mesh stent is coupled to a flexible rod that extends through a valve commissure into the ventricle and wherein a distal end of a flexible rod couples to a distal anchor and provides consistent tension on the tether during a heart cycle.

Implant deployment apparatus

A delivery system (100), including a restraining member (102), maintains a collapsed implant (106) in its collapsed state for delivery through a small passageway to a desired site in a mammalian body. Once the implant is positioned at the desired site, the restraining member is released so that the stent may expand or be expanded to its expanded state. In a preferred embodiment, the restraining member comprises a sheet of material that surrounds at least a portion of the collapsed stent. Portions of the restraining member are releasably coupled to one another with a low profile thread-like member or suture.

Endolumenal stent-graft with leak-resistant seal

An implantable medical device has a tubular member and a sealing member secured to an outer surface of the tubular member. The tubular member is expandable to engage an endolumenal wall and has a lumen for providing an artificial conduit for flow through an endolumenal space defined by that wall. The seal member occludes flow around the tubular member between the outer surface and the endolumenal wall. One suitable tubular member for use in the present invention is a stent-graft which may be bifurcated for use in protecting vascular wall malformations adjacent to vascular bifurcations against endolumenal pressure and flow. The seal member may be a flange that is oriented on the outer surface at one end of the tubular member as a one-way valve against flow. Multiple seal members may be used, either on opposite ends of the tubular member or in series at one end thereof. Where anchors are used to secure the tubular member to the endolumenal wall, the seal member is positioned to protect against flow through leakage paths formed at localized areas of deformation in the tubular wall adjacent to the anchors. One or more seal members may also be used with two or more tubular members to prevent flow through endolumenal spaces that remain open to flow due to gaps between the multiple, parallel tubular members.

Kink-resistant bifurcated prosthesis

【課題】 従来技術の問題及び不利点を回避する管腔内人工器官を提供する。 【解決手段】 本発明の一実施態様の人工器官は分岐したステント又はステント移植片である。本発明のステント移植片構成は少なくとも二つのステント移植片部分を備えていてもよく、これらステント移植片部分は互いに異なった構造特性を有する。この構造特性は柔軟性及び軸方向剛性を含んでいてもよい。このような構成の場合には、性能特性を理想的な搬送に合わせて最適化すると同時に、装置の捩れ抵抗、展開された位置を維持する能力、及び順応性（これは血管壁に対する所望のシール性能を実現するのを助ける）を高めることが可能となる。好適な実施態様においては、軸線方向剛性が、延在する支柱機能部の有無又は様々な厚さ又は幅のテープ部材の使用に応じて変化させられる。 【選択図】 図１４Ａ

Devices for cardiac valve repair

Catheter with rapid exchange and OTW operative modes

An intravascular catheter having a relatively long proximal shaft portion, a relatively short distal shaft section and a flexible intermediate shaft which allows the articulation of the distal and proximal shaft sections. The intermediate shaft section has a guidewire port in fluid communication with a guidewire receiving inner lumen which extends through the catheter shaft. In one presently preferred embodiment the portion of the intermediate shaft section through which the guidewire lumen extends is formed by a helical coil having an expanded portion which defines the guidewire port. The catheter allows both rapid exchange and over-the-wire modes of operation.

Endolumenal stent-graft with leak-resistant seal

Kink resistant bifurcated prosthesis

The invention relates to an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular component adopted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Multi-catheter steerable guiding system and methods of use

Devices, systems, methods and kits are provided for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by a multi-catheter guiding system which is positioned in a desired configuration, generally directed toward the target tissue. Interventional devices may then be passed through the guiding system to the target tissue. Depending on the location of the target tissue and the desired angle of approach, the guiding system may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. The multi-catheter guiding system of the present invention comprises an outer guiding catheter and a coaxially positioned inner guiding catheter, each of which independently form curvatures so that together the curves properly direct the interventional device.

Methods, systems and devices for cardiac valve repair

Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heat chambers from the patient's arterial or venous vasculature remote from the heat. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

Articulatable access sheath and methods of use

The present invention provides devices, systems, methods and kits for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by an access sheath which is positioned in a desired configuration, generally directed toward the target tissue. Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. In addition, the access sheath has a locking feature to hold the sheath in place and maintain the desired configuration. Interventional devices may then be passed through the sheath to the target tissue.

Kink resistant bifurcated prosthesis

Methods and devices for capturing and fixing leaflets in valve repair

The present invention provides methods and devices (100) for grasping (106), and optional repositioning and fixation of the valve leaflets (LF) to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to inclu de grasping which pierces or otherwise permanently affects the leaflets. In som e of these cases, the grasping step includes fixation (115).

Catheter shaft with an oblong transverse cross-section

A balloon dilatation catheter having a catheter shaft with an oblong transverse cross-section with one transverse dimension in a first direction being significantly larger than a second transverse dimension in a direction perpendicular to the first direction. The first dimension is about 1.1 to about 3 times greater, preferably about 1.2 to about 2.5 times greater than the second dimension. In one embodiment, a length of the distal shaft section has inner and outer tubular members where about 30% to not more than about 90% of the inner periphery of the outer tubular member takes the shape of and is secured to the exterior of the inner tubular member. In another embodiment the flexible distal shaft section is an extruded section having an oval or elliptical transverse cross-section. Preferably a pseudoelastic hypotube of NiTi alloy defines at least part of the inflation lumen within the catheter shaft. In another embodiment of the invention the proximal shaft of the catheter has an inner and outer tubular member.

Kink resistant bifurcated prosthesis

Device for renal decongestion

Methods and apparatuses for pumping blood within a blood vessel are described. The methods and apparatuses are can be used for renal decongestion by pumping blood through the kidney(s), thereby increasing a pressure gradient across the kidney(s). The apparatuses can include one or more inflatable elements that can be repeatedly inflated and deflated to cause a pumping action within the blood vessel. In some embodiments, the one or more inflatable elements are positioned within one or more stents.

Implant deployment apparatus

A delivery system (100), including a restraining member (102), maintains a collapsed implant (106) in its collapsed state for delivery through a small passageway to a desired site in a mammalian body. Once the implant is positioned at the desired site, the restraining member is released so that the stent may expand or be expanded to its expanded state. In a preferred embodiment, the restraining member comprises a sheet of material that surrounds at least a portion of the collapsed stent. Portions of the restraining member are releasably coupled to one another with a low profile thread-like member or suture.

Knickbeständige bifurkationsprothese

Detachment mechanism for implantable fixation devices

Device and method for variable blood flow occlusion

A blood flow control device having a catheter adapted to be advanced into a blood vessel to a blood flow control site within the blood vessel; an expandable anchor supported by the catheter, the expandable anchor being adapted to expand to engage a wall of the blood vessel, the expandable anchor having a blood impermeable wall defining an adjustable blood flow path extending through the expandable anchor from a proximal opening to a distal opening, the catheter being disposed outside of the adjustable blood flow path; a flow control element supported by the catheter, the flow control element being adapted to change a dimension of the adjustable blood flow path to change a rate of blood flow through the blood flow path; and a blood flow control actuator disposed at a proximal section of the catheter and adapted to actuate the flow control element.

Endoluminales stent-gewebe mit leckbeständiger dichtung

Mitral valve implants

Implants and methods for treating diseased heart valves. The implants may include a support member configured for placement near the diseased valve and an anchoring system coupled to the support member. The support member may be used to treat regurgitation and/or support a valve replacement therein. The support member may have an annular shape with an opening configured to generally align with an opening of the diseased valve. In some examples, the support member includes a coaptation structure configured to seal with the native leaflets. The anchoring system may include one or more tethers anchored to tissue of a ventricle, such as a ventricle wall and/or a papillary muscle. In some examples, sufficient tension is applied on the tethers to stabilize or reduce ventricle dilation.

Vorrichtung zur entfaltung eines implantats

Mitral valve implants

Implants and methods for treating diseased heart valves. The implants may include a support member configured for placement near the diseased valve and an anchoring system coupled to the support member. The support member may be used to treat regurgitation and/or support a valve replacement therein. The support member may have an annular shape with an opening configured to generally align with an opening of the diseased valve. In some examples, the support member includes a coaptation structure configured to seal with the native leaflets. The anchoring system may include one or more tethers anchored to tissue of a ventricle, such as a ventricle wall and/or a papillary muscle. In some examples, sufficient tension is applied on the tethers to stabilize or reduce ventricle dilation.

Device and method for variable blood flow occlusion

A blood flow control device having a catheter adapted to be advanced into a blood vessel to a blood flow control site within the blood vessel; an expandable anchor supported by the catheter, the expandable anchor being adapted to expand to engage a wall of the blood vessel, the expandable anchor having a blood impermeable wall defining an adjustable blood flow path extending through the expandable anchor from a proximal opening to a distal opening, the catheter being disposed outside of the adjustable blood flow path; a flow control element supported by the catheter, the flow control element being adapted to change a dimension of the adjustable blood flow path to change a rate of blood flow through the blood flow path; and a blood flow control actuator disposed at a proximal section of the catheter and adapted to actuate the flow control element.

Device for renal decongestion

Methods and apparatuses for pumping blood within a blood vessel are described. The methods and apparatuses are can be used for renal decongestion by pumping blood through the kidney(s), thereby increasing a pressure gradient across the kidney(s). The apparatuses can include one or more inflatable elements that can be repeatedly inflated and deflated to cause a pumping action within the blood vessel. In some embodiments, the one or more inflatable elements are positioned within one or more stents.

Verfahren zur herstellung eines nickbeständigen stent-transplantates

Cardiac valve prosthesis delivery system and methods of use

Delivery systems, devices, and methods for delivering a valve prosthesis to a native valve annulus are provided. The valve prosthesis may be secured to the native valve via an anchor that encircles the native valve annulus and the valve prosthesis. The anchor may be deployed around the chordae tendinea and/or leaflets of the native valve. A tether may be connected to the anchor and extend outside of the patient's body to maintain communication with the anchor. After the anchor is deployed, a guidewire may be advanced through the patient's vessels parallel to the tether and through the native valve annulus. A valve delivery catheter carrying the valve prosthesis may be advanced over the guidewire and into the native valve annulus where the valve prosthesis is released and deployed. The tether may be used to position the anchor and/or valve prosthesis during one or more operations of the valve delivery process.

Cardiac valve prosthesis delivery system and methods of use

Delivery systems, devices, and methods for delivering a valve prosthesis to a native valve annulus are provided. The valve prosthesis may be secured to the native valve via an anchor that encircles the native valve annulus and the valve prosthesis. The anchor may be deployed around the chordae tendinea and/or leaflets of the native valve. A tether may be connected to the anchor and extend outside of the patient's body to maintain communication with the anchor. After the anchor is deployed, a guidewire may be advanced through the patient's vessels parallel to the tether and through the native valve annulus. A valve delivery catheter carrying the valve prosthesis may be advanced over the guidewire and into the native valve annulus where the valve prosthesis is released and deployed. The tether may be used to position the anchor and/or valve prosthesis during one or more operations of the valve delivery process.

Implant deployment apparatus

Kink resistant bifurcated prosthesis

Vorrichtungen zum ergreifen und festlegen von segeln bei der klappenreparatur

Device and method for variable blood flow occlusion

A blood flow control device having a catheter adapted to be advanced into a blood vessel to a blood flow control site within the blood vessel; an expandable anchor supported by the catheter, the expandable anchor being adapted to expand to engage a wall of the blood vessel, the expandable anchor having a blood impermeable wall defining an adjustable blood flow path extending through the expandable anchor from a proximal opening to a distal opening, the catheter being disposed outside of the adjustable blood flow path; a flow control element supported by the catheter, the flow control element being adapted to change a dimension of the adjustable blood flow path to change a rate of blood flow through the blood flow path; and a blood flow control actuator disposed at a proximal section of the catheter and adapted to actuate the flow control element.

Articulatable access system

Device and method for variable blood flow occlusion

A blood flow control device having a catheter adapted to be advanced into a blood vessel to a blood flow control site within the blood vessel; an expandable anchor supported by the catheter, the expandable anchor being adapted to expand to engage a wall of the blood vessel, the expandable anchor having a blood impermeable wall defining an adjustable blood flow path extending through the expandable anchor from a proximal opening to a distal opening, the catheter being disposed outside of the adjustable blood flow path; a flow control element supported by the catheter, the flow control element being adapted to change a dimension of the adjustable blood flow path to change a rate of blood flow through the blood flow path; and a blood flow control actuator disposed at a proximal section of the catheter and adapted to actuate the flow control element.

Cardiac valve prosthesis delivery system and methods of use

Delivery systems, devices, and methods for delivering a valve prosthesis to a native valve annulus are provided. The valve prosthesis may be secured to the native valve via an anchor that encircles the native valve annulus and the valve prosthesis. The anchor may be deployed around the chordae tendinea and/or leaflets of the native valve. A tether may be connected to the anchor and extend outside of the patient's body to maintain communication with the anchor. After the anchor is deployed, a guidewire may be advanced through the patient's vessels parallel to the tether and through the native valve annulus. A valve delivery catheter carrying the valve prosthesis may be advanced over the guidewire and into the native valve annulus where the valve prosthesis is released and deployed. The tether may be used to position the anchor and/or valve prosthesis during one or more operations of the valve delivery process.

Device and method for variable blood flow occlusion

A blood flow control device with a catheter advanceable into a blood vessel to a blood flow control site; an anchor having an uncompressed configuration and a compressed configuration, the anchor comprising a proximal portion and a distal portion with a smaller diameter than the proximal portion, the proximal portion expandable toward the uncompressed configuration to engage a wall of the blood vessel, a blood impermeable wall defines a blood flow path through the anchor from a proximal opening to a distal opening at a distal end of the distal portion, the catheter being disposed outside of the adjustable blood flow path; a flow element comprising a cinching line to change a shape of the distal portion of the anchor and a rate of blood flow through the blood flow path when the distal portion of the anchor changes from a first shape to a second shape.

Minimal frame prosthetic cardiac valve delivery devices, systems, and methods

Methods and devices for tissue grasping and assessment

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.