CN-122028876-A - Systems, devices, and methods for reducing heart valve regurgitation

Abstract

Embodiments described herein relate to an implant delivery system for delivering an implant to reduce heart valve regurgitation. The implant delivery system may include an implant catheter disposed in an inner lumen of a guide catheter. The implant catheter may include one or more hypotubes disposed therein, each hypotube configured to receive an elongate member, such as a braided tether. The distal end of the implant catheter may be coupled to an implant holder configured to receive the implant. The implant holder may define one or more channels, each channel configured to receive a portion of a respective elongate member. The elongate member is configured to couple the implant to the implant holder and transition the implant between configurations. The implant is configured to be disposed around a portion of a leaflet of a heart valve to improve engagement of the heart valve.

Inventors

• Shao Yi Muradihar Padala

Assignees

• 埃默里大学

Dates

Publication Date

20260512

Application Date

20240823

Priority Date

20240724

Claims (20)

1. 1. An implant for reducing heart valve regurgitation, the implant comprising: An attachment portion comprising at least a first portion of a first arm and a second arm configured to couple the implant to a first native leaflet, and An engagement portion configured to provide a contact surface for a second native leaflet, Wherein the engagement portion includes a plurality of support members, each support member extending from the first arm to a respective free end.
2. 2. The implant of claim 1, wherein the second portion of the second arm forms a portion of the engagement portion.
3. 3. The implant of claim 1, wherein the engagement portion is further configured to receive at least a portion of the first native leaflet.
4. 4. The implant of claim 1, wherein the maximum width of the first arm is about 1.05 times to about 1.75 times greater than the maximum width of the second arm.
5. 5. The implant of claim 1, wherein the length of the first arm is about 1.05 times to about 1.5 times greater than the length of the second arm.
6. 6. The implant of claim 1, wherein the first arm comprises a first planar portion and the second arm comprises a second planar portion.
7. 7. The implant of claim 6, wherein each of the first and second planar portions is configured to contact the first native leaflet.
8. 8. The implant of claim 6, wherein the first planar portion and the second planar portion are configured to be coplanar in a first configuration.
9. 9. The implant of claim 8, wherein in the first configuration, a distal end of the first arm extends distally beyond a distal end of the second arm.
10. 10. The implant of claim 1, wherein the implant has a length that is between about 50% and about 100% of the length of the first native leaflet.
11. 11. The implant of claim 1, wherein the length of the second arm is between about 25% and about 75% of the length of the implant.
12. 12. The implant of claim 1, wherein the first arm is configured to be coupled to an atrial surface of the native leaflet and the second arm is configured to be coupled to a ventricular surface of the first native leaflet.
13. 13. The implant of claim 1, wherein the plurality of support members comprises between two and six support members.
14. 14. The implant of claim 13, wherein the plurality of support members comprises four support members.
15. 15. The implant of claim 1, wherein a portion of at least one support member of the plurality of support members is configured to contact the first native leaflet.
16. 16. The implant of claim 1, wherein at least one support member of the plurality of support members is configured to avoid contact with the first native leaflet.
17. 17. The implant of claim 1, wherein each support member of the plurality of support members is configured to be temporarily deformed for placement within a delivery device.
18. 18. The implant of claim 1, wherein a portion of a first support member of the plurality of support members is configured to contact the first native leaflet and a second support member of the plurality of support members is configured to avoid contact with the first native leaflet.
19. 19. The implant of claim 1, wherein at least one support member of the plurality of support members is configured to be comprised by the second native valve She Pianzhuai.
20. 20. The implant of claim 1, wherein at least one of the support members has a first portion having a convex shape and a second portion having a concave shape.

Description

Systems, devices, and methods for reducing heart valve regurgitation Government supported validation statement The present invention was completed with government support under grant HL135145 awarded by the national institutes of health. The government has certain rights in this invention. Cross Reference to Related Applications The present application claims the benefit of U.S. patent application Ser. No. 18/782,496, entitled "Systems, devices, and Methods for Reducing HEART VALVE Regurgitation," filed 24 at 7, 2024, which claims the priority of U.S. provisional application Ser. No. 63/578,923, entitled "Systems, devices, and Methods for Reducing HEART VALVE Regurgitation," filed 25, 8, 2023, the disclosure of which is incorporated herein by reference. Technical Field Embodiments described herein relate to implants and implant delivery systems for reducing heart valve regurgitation. In particular, embodiments described herein relate to transcatheter delivery systems for delivering an implant to a mitral heart valve. Background Heart valve regurgitation, particularly Functional Mitral Regurgitation (FMR), is a common heart valve pathology in Heart Failure (HF) patients, and has been shown to exacerbate the progression of heart failure and increase mortality in patients. Most heart failure patients have too high surgical risk due to poor health. Minimally invasive transcatheter methods exist for delivering implants to heart valves (e.g., mitral valves), however, current implantation techniques do not adequately treat FMR and can disrupt native valve dynamics, resulting in poor long-term durability. Drawings Fig. 1A is a diagram showing the coaptation at the annular plane of the heart valve (left) and the expansion of the annulus and ventricular chambers that deform the heart valve and cause regurgitation of the heart valve. Fig. 1B is a diagram showing mitral regurgitation (left) during systole and treating heart valve regurgitation (right) with an implant. Fig. 2A-2C are schematic diagrams of an implant delivery system for reducing heart valve regurgitation during different phases of implant delivery according to an embodiment. Fig. 3 is a schematic block diagram of an implant holder of an implant delivery system according to an embodiment. Fig. 4 is a schematic view of an implant for reducing heart valve regurgitation in accordance with an embodiment. Fig. 5A is an illustration of an implant delivery system including a multi-lumen implant catheter and an implant holder according to an embodiment. Fig. 5B shows a close-up of the distal end of the implant delivery system according to an embodiment. Fig. 5C is an image of an implant delivery system including a handle assembly, an implant catheter, and an implant holder according to an embodiment. Fig. 6 shows images of the proximal control mechanism of each catheter and the steerability of the catheter of the implant delivery system according to an embodiment. Fig. 7A-7C illustrate the maneuverability of an implant delivery system including three catheters according to an embodiment. Fig. 8 is a diagram of an implant holder of an implant delivery system according to an embodiment. Fig. 9A-9C illustrate images of an implant holder of an implant delivery system including an implant coupled thereto according to an embodiment. Fig. 10-15 depict implants for treating heart valve regurgitation in accordance with various embodiments. Fig. 16A-16C illustrate front perspective (fig. 16A), rear perspective (fig. 16B), and bottom views (fig. 16C) of an implant according to an embodiment. Fig. 17A illustrates a front view of an implant according to an embodiment. Fig. 17B illustrates a front view of the first arm of the implant of fig. 17A, according to an embodiment. Fig. 17C illustrates a front view of a second arm of the implant body of fig. 17A, according to an embodiment. Fig. 17D illustrates a rear perspective view of the implant of fig. 17A, according to an embodiment. Fig. 17E illustrates a front perspective view of the implant of fig. 17A, according to an embodiment. Fig. 17F shows a bottom view of the implant of fig. 17A. Fig. 17G shows a side view of the implant of fig. 17A. Fig. 18A-18C illustrate front, rear and bottom views, respectively, of a first plate of an implant according to an embodiment. Fig. 19A-19C illustrate front, side and bottom views of a second plate of an implant according to an embodiment. Fig. 20A illustrates a top perspective view of an implant according to an embodiment. Fig. 20B-20E illustrate an edge of an implant where one or more plates are welded to the implant, according to an embodiment. Fig. 21A-21B illustrate a portion of a first arm showing a visual marker received within an implant, according to an embodiment. Fig. 22A-22C illustrate a cover for an implant for treating heart valve regurgitation according to an embodiment. Fig. 23A shows a top view of a cover in a flat configuration according to an embodiment. Fig. 23B-23C ill