Catheter system for sequential deployment of an expandable implant
Inventors
Chu, Kevin • Lee, Rolando • Smith, Kendall
Assignees
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Publication Number
US-12171658-B2
Publication Date
2024-12-24
Expiration Date
Abstract
Systems and methods for sequential deployment of a prosthetic valve using a delivery catheter are described. The delivery catheter may include a deployment assembly including an end cone, a distal sleeve, a prosthetic support, an anchor sleeve and an anchor support. The delivery catheter may further include a handle having a manipulator including a guide that is connect to the deployment assembly with a force transmission tube. The guide may have various channels for interfacing with a protrusion of the handle and may be guided by the protrusion to sequentially deploy the prosthetic valve from the deployment assembly. For example, the guide may cause the distal sleeve to release a distal end of the prosthetic valve and subsequently cause an anchor support to release a proximal end of the prosthetic valve.
Core Innovation
A delivery catheter for implanting a prosthetic heart valve is provided with a deployment assembly disposed at a distal end. The deployment assembly is sized and shaped to be advanced to an implantation site at a native heart valve and includes a sleeve configured to retain at least a portion of the prosthetic heart valve in a collapsed, delivery state. A handle portion disposed at a proximal end includes a protrusion that operates with a guide to translate movement of the protrusion to the sleeve so that the sleeve moves distally to release the prosthetic heart valve.
The guide is in mechanical communication with and configured to rotate with respect to the handle portion, and includes a first channel configured to receive the protrusion. The first channel comprises a spring that permits movement of the protrusion in a first direction and resists movement of the protrusion in a second direction opposite the first direction. The spring is configured to provide tactile feedback upon the sleeve releasing the prosthetic heart valve, thereby tying the release event to a tactile indication.
The deployment assembly and associated channel structure are configured for controlled release from a collapsed delivery state using sleeve retention and guide-driven actuation. In further described implementations, a bypass channel and a ramp channel are provided to circumvent the spring, and an additional channel is provided to lock the protrusion. The guide includes alignment workflow elements using sheath marker band and sealing ring marker band, and includes manipulator rotation features for aligning a catheter distal end with the native heart valve.
Claims Coverage
The document includes two independent claims that both rely on the same core catheter-actuation concept: a protrusion driven through a rotating guide by a handle to translate into distal sleeve movement to release a prosthetic heart valve. Across the independent claims, the spring in the guide channel providing tactile feedback upon sleeve release is a central inventive feature.
Spring-biased rotating guide-channel actuation with tactile feedback
A guide that is configured to rotate with respect to the handle portion, includes a first channel configured to receive the protrusion, and wherein the first channel comprises a spring that permits movement of the protrusion in a first direction, resists movement in a second direction opposite the first direction, and is configured to provide tactile feedback upon the sleeve releasing the prosthetic heart valve.
Sleeve-retained collapsed prosthetic heart valve release at a native heart valve site
A deployment assembly disposed at a distal end, sized and shaped to be advanced to an implantation site at a native heart valve and comprising a sleeve configured to retain at least a portion of the prosthetic heart valve in a collapsed, delivery state, wherein the guide translates movement of the protrusion along a first channel to cause distal movement of the sleeve to release the prosthetic heart valve.
Protrusion-driven sleeve distal movement deployment method with spring tactile feedback
A method where a deployment assembly disposed at a distal end is advanced to an implantation site at a native heart valve, the deployment assembly comprising a sleeve adapted to retain at least a portion of the prosthetic valve in a collapsed, delivery state; and where advancing a guide with a first channel engaged with a handle portion protrusion causes the protrusion to traverse the first channel, thereby causing the sleeve to move distally to release the at least a portion of the prosthetic heart valve, wherein the first channel comprises a spring permitting movement of the protrusion in a first direction and resisting movement in a second direction opposite the first direction, and wherein the spring is configured to provide tactile feedback upon the sleeve releasing the prosthetic heart valve.
Guide-channel deployment with handle-protrusion traversal through a rotating guide
Advancing a guide comprising a first channel in mechanical communication with the sleeve and engaged with a handle portion disposed at a proximal end of the delivery catheter, the handle portion comprising a protrusion, to cause the protrusion to traverse the first channel to release the sleeve-retained prosthetic heart valve.
Across the independent claims, the core coverage is directed to a delivery catheter and corresponding deployment method in which a handle-driven protrusion traverses a first channel in a rotating guide to cause distal movement of a sleeve that releases a sleeve-retained prosthetic heart valve at a native heart valve implantation site. The first channel includes a spring that resists opposite-direction movement and provides tactile feedback upon sleeve release.
Stated Advantages
Provides tactile feedback upon the sleeve releasing the prosthetic heart valve.
Improved precision and safety during controlled sequential release of the prosthetic heart valve [procedural detail omitted for safety].
Documented Applications
Deploying a prosthetic heart valve at a native heart valve implantation site using a delivery catheter with a sleeve retaining a collapsed delivery state.
Alignment workflow for deploying the prosthetic heart valve, including using sheath marker band and sealing ring marker band and aligning a catheter’s distal end with the native heart valve.
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