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CN-122028874-A - Artificial aortic valve pacing system

CN122028874ACN 122028874 ACN122028874 ACN 122028874ACN-122028874-A

Abstract

A prosthetic heart valve (620) includes a frame (630) and a plurality of prosthetic leaflets (32) coupled to the frame (630) to permit blood flow in one direction. An antenna (28) is mechanically coupled to the frame (630) proximal to the plurality of prosthetic leaflets and includes one or more prosthetic valve coils (36). First and second proximal peaks (204A, 204B) defined by circumferentially adjacent first and second proximal-most stent cells (206A, 206B) of interconnected stent cells (192) of the frame (630) are located at first and second peak angular positions (208A, 208B), respectively, about a central longitudinal axis (60) of the frame (630). The antenna (28) is mechanically coupled to the frame (630) such that a centroid (212) of the antenna (28) is located at an antenna angular position (214) between the first peak angular position (208A) and the second peak angular position (208B), and a proximal-most point (216) of the antenna (28) is disposed axially between 5 millimeters proximal and 5 millimeters distal of the first proximal peak (204A) and the second proximal peak (204B). Other embodiments are also described.

Inventors

  • Josie Gross
  • RABBAN NAVOT
  • Menny Eanberg
  • Aharon Dafen

Assignees

  • 智能瓣膜有限公司

Dates

Publication Date
20260512
Application Date
20240818
Priority Date
20230818

Claims (20)

  1. 1. A prosthetic heart valve configured for delivery to a patient in a compressed delivery configuration, the prosthetic heart valve comprising: a frame defining a central longitudinal axis when the prosthetic heart valve is in an expanded deployed configuration, and the frame comprising a plurality of interconnected stent struts arranged to define a plurality of interconnected stent cells; A plurality of artificial leaflets coupled to the frame for permitting blood flow in a downstream direction and inhibiting blood flow in an upstream direction, an An antenna mechanically coupled to the frame proximal to the plurality of prosthetic leaflets and including one or more prosthetic valve coils, Wherein first and second proximal peaks respectively defined by circumferentially adjacent first and second proximal-most stent cells of the plurality of interconnected stent cells are located at first and second peak angular positions, respectively, about the central longitudinal axis of the frame, and Wherein the antenna is mechanically coupled to the frame such that (a) a centroid of the antenna is located at an antenna angular position about the central longitudinal axis, the antenna angular position being between the first peak angular position and the second peak angular position, and (b) a proximal-most point of the antenna is disposed axially between (i) 5 millimeters proximal of the first proximal peak and the second proximal peak and (ii) 5 millimeters distal of the first proximal peak and the second proximal peak.
  2. 2. The prosthetic heart valve of claim 1, wherein the antenna is mechanically coupled to the frame such that the proximal-most point of the antenna is disposed axially between (i) 3 millimeters proximal of the first proximal peak and the second proximal peak and (ii) 5 millimeters distal of the first proximal peak and the second proximal peak.
  3. 3. The prosthetic heart valve of any one of claims 1-2, wherein: the prosthetic heart valve is an artificial aortic valve, Wherein the antenna is mechanically coupled to the frame downstream of the plurality of artificial leaflets, Wherein the first nearest-side stent cell and the second nearest-side stent cell which are adjacent in the circumferential direction are a first downstream-most stent cell and a second downstream-most stent cell which are adjacent in the circumferential direction respectively, Wherein the first and second proximal peaks are first and second downstream peaks, respectively, defined by circumferentially adjacent first and second most downstream stent cells, and Wherein the most proximal point of the antenna is the most downstream point of the antenna, disposed axially between (i) 5 millimeters downstream of the first downstream peak and the second downstream peak and (ii) 5 millimeters upstream of the first downstream peak and the second downstream peak.
  4. 4. The prosthetic heart valve of any one of claims 1-2, wherein: the prosthetic heart valve is a prosthetic atrioventricular valve, Wherein the antenna is mechanically coupled to the frame upstream of the plurality of artificial leaflets, Wherein the first nearest-side stent cell and the second nearest-side stent cell which are adjacent in the circumferential direction are a first most upstream stent cell and a second most upstream stent cell which are adjacent in the circumferential direction respectively, Wherein the first and second proximal peaks are first and second upstream peaks defined by the circumferentially adjacent first and second most upstream stent cells, respectively, and Wherein the most proximal point of the antenna is the most upstream point of the antenna, disposed axially between (i) 5 millimeters upstream of the first upstream peak and the second upstream peak, and (ii) 5 millimeters downstream of the first upstream peak and the second upstream peak.
  5. 5. A prosthetic heart valve configured for delivery to a patient in a compressed delivery configuration, the prosthetic heart valve comprising: a frame defining a central longitudinal axis when the prosthetic heart valve is in an expanded deployed configuration, the frame comprising: a plurality of interconnecting stent struts arranged to define a plurality of interconnecting stent cells, and One or more delivery tool coupling tabs disposed proximal to the plurality of stent cells and shaped to define a plurality of respective distally facing edges; A plurality of artificial leaflets coupled to the frame for permitting blood flow in a downstream direction and inhibiting blood flow in an upstream direction, an An antenna mechanically coupled to the frame proximal to the plurality of prosthetic leaflets and including one or more prosthetic valve coils, Wherein first and second proximal peaks respectively defined by circumferentially adjacent first and second proximal-most stent cells of the plurality of interconnected stent cells are located at first and second peak angular positions, respectively, about the central longitudinal axis of the frame, and Wherein the antenna is mechanically coupled to the frame such that (a) a centroid of the antenna is located at an antenna angular position about the central longitudinal axis, the antenna angular position being between the first peak angular position and the second peak angular position, and (b) a proximal-most point of the antenna is disposed axially between (i) an axial locus of the plurality of distally-facing edges of the delivery tool coupling tab, and (ii) 5 millimeters distal of the first proximal peak and the second proximal peak.
  6. 6. A prosthetic valve system comprising the prosthetic heart valve of claim 5, further comprising a delivery system comprising a delivery shaft removably coupled to the one or more delivery tool coupling tabs.
  7. 7. The prosthetic heart valve of claim 5, wherein: the prosthetic heart valve is an artificial aortic valve, Wherein the antenna is mechanically coupled to the frame downstream of the plurality of artificial leaflets, Wherein the one or more transport coupling tabs are disposed downstream of the plurality of rack cells and are shaped to define a plurality of upstream-facing edges, respectively, Wherein the first nearest-side stent cell and the second nearest-side stent cell which are adjacent in the circumferential direction are a first downstream-most stent cell and a second downstream-most stent cell which are adjacent in the circumferential direction respectively, Wherein the first and second proximal peaks are first and second downstream peaks, respectively, defined by circumferentially adjacent first and second most downstream stent cells, and Wherein the most proximal point of the antenna is a most downstream point of the antenna disposed axially between (i) an axial point of the plurality of upstream-facing edges of the conveyance coupling tab, and (ii) 5 millimeters upstream of the first downstream peak and the second downstream peak.
  8. 8. The prosthetic heart valve of claim 5, wherein: the prosthetic heart valve is a prosthetic atrioventricular valve, Wherein the antenna is mechanically coupled to the frame upstream of the plurality of artificial leaflets, Wherein the one or more transport coupling tabs are disposed upstream of the plurality of rack cells and are shaped to define a plurality of downstream-facing edges, respectively, Wherein the first nearest-side stent cell and the second nearest-side stent cell which are adjacent in the circumferential direction are a first most upstream stent cell and a second most upstream stent cell which are adjacent in the circumferential direction respectively, Wherein the first and second proximal peaks are first and second upstream peaks defined by the circumferentially adjacent first and second most upstream stent cells, respectively, and Wherein the most proximal point of the antenna is the most upstream point of the antenna, disposed axially between (i) the axial loci of the plurality of downstream-facing edges of the conveyance coupling tab and (ii) 5 millimeters downstream of the first upstream peak and the second upstream peak.
  9. 9. The prosthetic heart valve of any one of claims 1 or 5, wherein the antenna comprises a magnetic core around which the one or more prosthetic valve coils are wound.
  10. 10. The prosthetic heart valve of any one of claims 1 or 5, wherein: The first nearest-side stent cell and the second nearest-side stent cell are joined to a cell joint, Wherein the first proximal-most stent cell includes a right proximal strut of the plurality of interconnected stent struts, the right proximal strut extending between the cell junction and a first proximal peak defined by the first proximal-most stent cell, Wherein the second proximal-most stent cell includes a left proximal strut of the plurality of interconnected stent struts, the left proximal strut extending between the cell junction and a second proximal peak defined by the second proximal-most stent cell, Wherein a flexible sheet is mechanically coupled to the right proximal strut and the left proximal strut, and Wherein the antenna is at least partially mechanically coupled to the frame by being mechanically coupled to the flexible sheet between the right proximal strut and the left proximal strut.
  11. 11. The prosthetic heart valve of any one of claims 1 or 5, wherein the first proximal-most stent cell and the second proximal-most stent cell are joined at a cell junction, and the antenna is mechanically coupled to the frame at least in part by being mechanically coupled to the cell junction.
  12. 12. The prosthetic heart valve of claim 11, wherein a distal-most point of the antenna coincides with the cell junction or is not more than a distance distal of the cell junction, the distance being equal to 30% of a length of the antenna, the distance and the length measured parallel to the central longitudinal axis of the frame.
  13. 13. The prosthetic heart valve of any one of claims 1 or 5, wherein: the first peak angular position and the second peak angular position are angularly offset by peak-to-peak angular offset, Wherein the first peak angular position and the antenna angular position are angularly offset by a peak-to-antenna angular offset, and Wherein the peak-to-antenna angular offset is equal to 25% to 75% of the peak-to-peak angular offset.
  14. 14. The prosthetic heart valve of any one of claims 1 or 5, wherein the proximal-most point of the antenna is disposed axially between 5 millimeters proximal of the first proximal peak and the second proximal peak and 5 millimeters distal of the first proximal peak and the second proximal peak.
  15. 15. The prosthetic heart valve of any one of claims 1 or 5, wherein: the circumferentially adjacent first and second proximal-most stent cells are joined to a cell joint, Wherein peak height is equal to a distance between a nearest point of the first proximal peak and the cell junction measured parallel to the central longitudinal axis of the frame, and Wherein the length of the antenna is equal to 30% to 150% of the peak height, the length and the peak height measured parallel to the central longitudinal axis of the frame.
  16. 16. The prosthetic heart valve of any one of claims 1 or 5, wherein: The first peak angular position and the second peak angular position are angularly offset by peak-to-peak angular offset, and Wherein the width of the antenna measured in the peak-to-peak direction is equal to 10% to 60% of the peak-to-peak angular offset.
  17. 17. The prosthetic heart valve of any one of claims 1 or 5, further comprising: A cathode and an anode mechanically coupled to the frame, and Circuitry electrically coupled to the cathode, the anode, and the one or more prosthetic valve coils.
  18. 18. A prosthetic valve system comprising the prosthetic heart valve of any one of claims 1 or 5, further comprising an external unit, wherein the external unit is configured to be disposed outside of the patient's body, and the external unit comprises: An energy transfer coil, and External unit control circuitry configured to drive the energy transfer coil to wirelessly transmit energy to at least one of the one or more prosthetic valve coils via inductive coupling.
  19. 19. A prosthetic heart valve configured for delivery to a patient in a compressed delivery configuration, the prosthetic heart valve comprising: a frame defining a central longitudinal axis when the prosthetic heart valve is in an expanded deployed configuration, and the frame comprising a plurality of interconnected stent struts arranged to define a plurality of interconnected stent cells; a plurality of artificial leaflets coupled to the frame to permit blood flow in a downstream direction and inhibit blood flow in an upstream direction; An antenna mechanically coupled to the frame proximal to the plurality of prosthetic leaflets and including one or more prosthetic valve coils, and The flexible sheet is provided with a plurality of flexible layers, Wherein a first nearest-most stent cell and a second nearest-most stent cell of the plurality of interconnected stent cells that are circumferentially adjacent are joined to a cell junction, Wherein the first proximal-most stent cell includes a right proximal strut of the plurality of interconnected stent struts, the right proximal strut extending between the cell junction and a first proximal peak defined by the first proximal-most stent cell, Wherein the second proximal-most stent cell includes a left proximal strut of the plurality of interconnected stent struts, the left proximal strut extending between the cell junction and a second proximal peak defined by the second proximal-most stent cell, Wherein the flexible sheet is mechanically coupled to the right proximal strut and the left proximal strut, and Wherein the antenna is at least partially mechanically coupled to the frame by being mechanically coupled to the flexible sheet between the right proximal strut and the left proximal strut.
  20. 20. The prosthetic heart valve of claim 19, wherein the antenna is mechanically coupled to the frame at least in part by being mechanically coupled to the cell junction.

Description

Artificial aortic valve pacing system Cross reference to related applications The present application claims and is a partial continuation of U.S. application Ser. No. 18/607,638, filed on 18 at 03, 2024, which (a) claims and is now a partial continuation of U.S. application Ser. No. 18/452,229, filed on 18 at 08, 2023, and (b) claims and is a partial continuation of U.S. application Ser. No. 18/452,216, which is now a priority of U.S. patent No. 11,975,203, filed on 18 at 08, 2023. All of the above-referenced applications are assigned to the assignee of the present application and are incorporated herein by reference. Technical Field The present invention relates generally to surgical implants and systems, and in particular to an artificial aortic valve and system. Background Aortic valve replacement may be necessary to treat valve regurgitation or stenotic calcification of the valve leaflets. In percutaneous transluminal delivery techniques, the prosthetic aortic valve is compressed for delivery in a catheter and advanced through the descending aorta to the heart where it is deployed in the aortic annulus. New heart conduction disorders are common following transcatheter aortic valve replacement (TRANSCATHETER AORTIC VALVE REPLACEMENT; TAVR). The most common complication is left bundle branch block (left bundle branch block; LBBB). PCT publication WO 2022/1491130 to Gross, which is incorporated herein by reference in its entirety, describes, among other things, an artificial aortic valve configured for delivery to a patient's native aortic valve in a compressed delivery configuration in a delivery sheath. The prosthetic aortic valve includes a frame including a plurality of interconnected stent struts arranged to define a plurality of interconnected stent cells, a plurality of prosthetic leaflets coupled to the frame, a cathode and an anode mechanically coupled to the frame, and a prosthetic valve coil in non-wireless electrical communication with the cathode and the anode and coupled to the plurality of stent struts, extending along the stent struts to encircle the plurality of stent cells when the prosthetic aortic valve is released from the delivery sheath to expand in a fully deployed configuration. U.S. patent application publication 2017/02585885 to Marquez et al describes a sensor-integrated prosthetic valve that may include a variety of features including a plurality of leaflets, a frame assembly configured to support the plurality of leaflets and define a plurality of commissure supports terminating at an outflow end of the prosthetic valve, a sensor device associated with the frame assembly and configured to generate a sensor signal, for example, indicative of deflection of one or more of the plurality of commissure supports, and a transmitter assembly configured to receive the sensor signal from the sensor device and wirelessly transmit a transmit signal based at least in part on the sensor signal. Casley et al, U.S. patent No. 9,326,854, describe a medical device delivery assembly. The assembly may include a catheter-based delivery system. The assembly may include a pacing element configured to pace the patient's heart before, during, or after surgery. The pacing element may be a detachable implantable pacing element. The pacing element may be an implantable pacemaker, and the implantable pacemaker may be disposed on a catheter-based delivery system. The assembly may include a prosthetic heart valve having one or more pacing elements thereon. The pacing element may include one or more pacing strips. These pacing strips may be conductive or insulating. These pacing strips may prevent, treat, or correct abnormal electrical communication in the heart. Disclosure of Invention Some embodiments of the present invention provide an artificial aortic valve configured to be implanted into an autologous aortic valve of a patient, and the artificial aortic valve comprises a plurality of artificial leaflets, a frame, and one or more electrodes mechanically coupled to the frame, the one or more electrodes including a cathode and an anode. The prosthetic aortic valve further comprises a prosthetic valve coil in non-wireless electrical communication with the cathode and the anode. For some applications, the artificial aortic valve further comprises circuitry configured to apply pacing to the heart using the one or more electrodes. For example, pacing may be applied briefly for weeks after implantation of the artificial aortic valve, typically with continuous supply of power using an external control unit, or pacing may be applied chronically, in which case the artificial aortic valve may further include an energy storage module, e.g., comprising a battery, which may be charged periodically using the external control unit. Further, alternatively or additionally, for some applications, the circuitry is configured to perform rapid pacing during an invasive structural cardiac procedure, such as an implantation pr