Stented transcatheter prosthetic heart valve delivery system and method
First Claim
1. A delivery device for percutaneously deploying a stented heart valve prosthesis, the device including:
- an inner shaft assembly defining a distal tip, a proximal end, and an intermediate portion providing a coupling structure configured to selectively engage a stented heart valve prosthesis;
a sheath forming a lumen sized to slidably receive at least the intermediate portion of the inner shaft assembly, the sheath terminating at a distal region; and
a tubular delivery capsule formed separately from the sheath, the capsule includes a cut tube defining;
a proximal zone attached to the distal region of the sheath,a distal zone terminating a distal end, wherein the distal zone is configured to transition between a normal state and a flared state, a diameter of the distal end being greater in the flared state than in the normal state, the distal zone including a base opposite the distal end and a plurality of generally longitudinally extending primary splines extending from the base and each terminating at a spline distal end opposite the base, wherein the plurality of splines includes a first spline, a second spline immediately adjacent the first spline, and a third spline immediately adjacent the first spline opposite the second spline, and even further wherein the spline distal ends of the first and second splines are interconnected at a bond point, and the spline distal ends of the first and third splines are not interconnected by a bond point,wherein the capsule includes a shape memory component constructed to naturally assume the normal state;
wherein the device is configured to slidably receive a stented heart valve prosthesis within the delivery capsule and is operable to perform a reversible partial deployment procedure in which a portion of the stented heart valve prosthesis is exposed distal the capsule and radially expands, followed by distal advancement of the capsule relative to the stented heart valve prosthesis whereby the distal zone transitions to the flared state and imparts a collapsing force onto the stented heart valve prosthesis, causing the stented heart valve prosthesis to radially collapse.
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Accused Products
Abstract
A percutaneous stented valve delivery device including an inner shaft, a sheath, and a delivery capsule. The sheath slidably receives the inner shaft. A capsule proximal zone is attached to the sheath. A capsule distal zone is configured to transition between normal and flared states. A diameter of the distal zone is greater in the flared state, and the capsule includes a shape memory component that naturally assumes the normal state. The device is operable to perform a reversible partial deployment procedure in which a portion of the prosthesis is exposed distal the capsule and allowed to radially expand. Subsequently, with distal advancement of the capsule, the distal zone transitions to the flared state and imparts a collapsing force onto the prosthesis, causing the prosthesis to radially collapse and become recaptured within the delivery capsule. The capsule can include a laser cut tube encapsulated by a polymer.
100 Citations
14 Claims
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1. A delivery device for percutaneously deploying a stented heart valve prosthesis, the device including:
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an inner shaft assembly defining a distal tip, a proximal end, and an intermediate portion providing a coupling structure configured to selectively engage a stented heart valve prosthesis; a sheath forming a lumen sized to slidably receive at least the intermediate portion of the inner shaft assembly, the sheath terminating at a distal region; and a tubular delivery capsule formed separately from the sheath, the capsule includes a cut tube defining; a proximal zone attached to the distal region of the sheath, a distal zone terminating a distal end, wherein the distal zone is configured to transition between a normal state and a flared state, a diameter of the distal end being greater in the flared state than in the normal state, the distal zone including a base opposite the distal end and a plurality of generally longitudinally extending primary splines extending from the base and each terminating at a spline distal end opposite the base, wherein the plurality of splines includes a first spline, a second spline immediately adjacent the first spline, and a third spline immediately adjacent the first spline opposite the second spline, and even further wherein the spline distal ends of the first and second splines are interconnected at a bond point, and the spline distal ends of the first and third splines are not interconnected by a bond point, wherein the capsule includes a shape memory component constructed to naturally assume the normal state; wherein the device is configured to slidably receive a stented heart valve prosthesis within the delivery capsule and is operable to perform a reversible partial deployment procedure in which a portion of the stented heart valve prosthesis is exposed distal the capsule and radially expands, followed by distal advancement of the capsule relative to the stented heart valve prosthesis whereby the distal zone transitions to the flared state and imparts a collapsing force onto the stented heart valve prosthesis, causing the stented heart valve prosthesis to radially collapse. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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Specification