CN-122028873-A - Systems and methods for improving prosthetic valve deployment

Abstract

The present disclosure provides apparatus, systems, and methods for various devices, such as prosthetic valves. Some examples relate to improvements in anchoring at native heart valves, which may reduce trauma that may be caused to the treatment or implantation site. Compliant and flexible anchoring features and methods are disclosed to reduce forces experienced at treatment or implantation sites around the mitral or tricuspid valve leaflet, including heart tissue. Improved device deployment mechanisms, including motorized methods, are also disclosed.

Inventors

• M. R. Sarari
• Y. D. Kaufman
• S. Wade
• A. Y. Kupai
• C. A.L. Chavez
• T. J. Gasca
• M.A. PETERSON

Assignees

• 爱德华兹生命科学公司

Dates

Publication Date

20260512

Application Date

20241001

Priority Date

20231003

Claims (20)

1. 1. A device for use at or deployment to a native heart valve, the device comprising: A support structure comprising a proximal portion and a distal portion, and One or more anchors extending radially outward from or capable of extending radially outward from the support structure, wherein the one or more anchors include one or more of (a) a hook shape, (b) anchor arms bifurcated to form a plurality of prongs circumferentially diverging from each other, (c) a tip portion having undulations to increase flexibility of itself, (d) a tip portion having a braid, and/or (e) a tip portion having a loop.
2. 2. The device of claim 1, wherein the proximal end portion is an inlet end portion, the distal end portion is an outlet end portion, and a passageway extends between the inlet end portion and the outlet end portion.
3. 3. The device of any one of claims 1-2, wherein the support structure comprises an inner frame having a proximal end portion and a distal end portion.
4. 4. The device of claim 3, wherein the support structure further comprises an outer frame comprising a proximal end portion.
5. 5. The device of claim 4, wherein the proximal end portion of the outer frame is coupled to the proximal end portion of the inner frame.
6. 6. The device of any one of claims 1-5, wherein the support structure comprises a platform portion extending radially outward from the proximal portion of the support structure to a shoulder of the support structure.
7. 7. The device of claim 6, wherein the support structure includes an axially extending portion extending axially from the shoulder to the distal portion of the support structure, the shoulder tilting the platform portion relative to the axially extending portion.
8. 8. The device of any one of claims 6 to 7, wherein the platform portion comprises a flexible feature that allows the platform portion to deflect to axially translate the inner frame relative to the shoulder.
9. 9. The device of claim 8, wherein the flexible feature comprises a portion of a brace of the support structure that is more flexible than an adjacent portion of the brace.
10. 10. The device of any of claims 8-9, wherein the flexible feature comprises an undulation of a strut of the outer frame.
11. 11. The device of any one of claims 1 to 10, wherein the device is a prosthetic heart valve deployable at a native heart valve.
12. 12. The device of any one of claims 1-11, further comprising a valve portion positioned within a passageway of the support structure, wherein the valve portion permits blood flow through the passageway in one direction but prevents blood flow in an opposite direction.
13. 13. The device of claim 12, wherein the valve portion comprises a plurality of prosthetic valve leaflets.
14. 14. The device of any one of claims 1-13, further comprising one or more anchors coupled to the distal portion of the support structure.
15. 15. The device of claim 14, wherein the one or more anchors each have a hook shape.
16. 16. The device of any one of claims 14 to 15, wherein the one or more anchors each comprise an anchor arm that diverges to form a plurality of prongs that diverge from one another.
17. 17. The apparatus of claim 16, wherein the anchor arm includes a split portion that diverges the anchor arm, and a stem portion positioned radially inward of the split portion.
18. 18. The device of claim 17, wherein the lever portion has a combined circumferential width equal to or greater than a circumferential width of each of the plurality of prongs.
19. 19. The device of claim 17 or claim 18, wherein the one or more anchors comprise a plurality of the anchors, and the plurality of prongs of the plurality of the anchors extend at least about 120 degrees across a perimeter of the device.
20. 20. The device of any one of claims 14 to 19, wherein the one or more anchors each comprise a tip portion having undulations for increasing the flexibility of the tip portion.

Description

Systems and methods for improving prosthetic valve deployment Cross Reference to Related Applications The present application claims the benefit of U.S. provisional application No. 63/542,259, filed on month 3 of 2023, the entire contents of which are incorporated herein by reference. Technical Field Features of the present disclosure relate to implants, including prosthetic valves for replacing the function of a native heart valve. Background The function of a human heart valve, including the aortic valve, pulmonary valve, mitral valve, and tricuspid valve, is substantially similar to a one-way valve that operates in synchronization with the pumping heart. The valve allows blood to flow downstream but prevents blood from flowing upstream. Diseased heart valves exhibit damage, such as narrowing or regurgitation of the valve, which inhibits the ability of the valve to control blood flow. Such damage can reduce the blood pumping efficiency of the heart and can lead to debilitating and life threatening conditions. For example, valve insufficiency may lead to conditions such as cardiac hypertrophy and ventricular dilation. Accordingly, there has been a great deal of effort to develop methods and apparatus for repairing or replacing damaged heart valves. Recently, there has been great effort to develop replacement heart valves, particularly tissue-based replacement heart valves, which can be delivered with less trauma to the patient than open heart surgery. Replacement valves are expected to achieve proper deployment and sealing at the implantation site. Disclosure of Invention This summary is intended to provide some examples and is not intended to limit the scope of the disclosure in any way. For example, any feature included in an example of this summary is not claimed unless the claim explicitly states such feature. Furthermore, the features, components, steps, concepts, etc. described in some embodiments of the disclosure and elsewhere in this disclosure may be combined in a variety of ways. Various features and steps described in other parts of the disclosure may be included in examples summarized herein. In some embodiments herein, implantable prostheses or implantable devices, such as replacement heart valves and/or valve repair devices, are provided. In some embodiments, the prostheses or devices herein include compliant anchoring mechanisms for prosthetic heart valves (also referred to as replacement heart valves). In some embodiments, improved delivery systems are provided for better controlling rotational and/or axial movement of a prosthesis or device (e.g., a prosthetic heart valve, prosthetic device, etc.). In some embodiments, improved imaging systems are provided for enhancing visualization during implantation procedures. These and other concepts may be used alone or in combination with other concepts described herein to facilitate implantation of a prosthetic heart valve. In some embodiments, prostheses or devices (e.g., heart valves, prosthetic devices, replacement devices, etc.) having improved anchoring are disclosed. In some embodiments, the prosthesis or device may be configured for use and/or implantation at a treatment site (e.g., implantation site, repair site, etc.). In some embodiments, the treatment site may be a native mitral valve or a native tricuspid valve (although other valves are contemplated for implantation, such as aortic, pulmonary, vena cava, etc.). In some embodiments, the improved anchoring features and/or methods are configured to improve stability while reducing trauma at or around the treatment or implantation site. For example, the systems, devices, methods, etc. herein are configured to reduce the likelihood of shock, compression, and/or potential bruises (e.g., pseudoaneurysms, myocardial punctures, or electrical conduction disorders). In some embodiments, the improved anchoring systems disclosed herein include compliant anchoring structures. In some embodiments, the anchor is a compliant or flexible anchor and is configured to reduce trauma to surrounding tissue at the treatment or implantation site. In some embodiments, mechanisms and/or methods for operation of the delivery system are also disclosed herein. In some embodiments, the mechanisms/methods are provided to improve the handling and deployment of devices or implants from an elongate delivery catheter, enabling treatment (e.g., repair, implantation, etc.) via a percutaneous non-invasive procedure. Various other improvements are disclosed. In some embodiments, a prosthesis or device (e.g., a prosthetic heart valve repair device, a replacement device, an implant, a therapeutic device, etc.) for and/or deployed to a native heart valve is provided. In some embodiments, a device (e.g., a prosthetic heart valve, etc.) includes a support structure having an inlet end portion. In some embodiments, the support structure includes an outlet end portion. The prosthesis or device may include any of the features of th