HEART CHAMBER PROSTHETIC VALVE IMPLANT WITH BASE, SPRING AND DOME SECTIONS WITH SINGLE CHAMBER ANCHORING FOR PRESERVATION, SUPPLEMENTATION AND/OR REPLACEMENT OF NATIVE VALVE FUNCTION

• US 20180042720A1
• Filed: 08/10/2017
• Published: 02/15/2018
• Est. Priority Date: 08/11/2016
• Status: Active Grant

• Current Assignee: 4C Medical Technologies, Inc.
• Original Assignee: 4C Medical Technologies, Inc.
• Inventors: Chambers, Jeffrey W.
• Granted Patent: US 10,828,152 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

Various embodiments of the present invention comprise a single-chamber collapsible and expandable prosthetic valve implant device comprising the following capabilities: (1) preservation of native valve functionality; (2) initial preservation of native valve functionality with subsequent full replacement of native valve functionality; (3) full replacement of native valve functionality; and/or (4) mitigation of the prolapsing distance of the dysfunctional leaflets by preventing the anterior excursion of the prolapsing leaflets above the upper annular surface and into the left atrial chamber in order to preserve native leaflet functionality for as long as possible. The expanded and implanted device does not extend beyond the boundaries of the subject heart chamber, e.g., the left atrium, thereby enabling the preservation of any remaining native valve functionality with subsequent full replacement of native valve functionality if and when needed.

Claims

1. A device for expanded implantation within a heart chamber that is in fluid communication with an annulus comprising an annular plane and with a native valve having leaflets, the device comprising:

a base section comprising a lower surface that is at least partially disposed on the annular plane, the lower surface at least partially disposed on the annular plane;

an atrial dome in pressured and frictional engagement with the chamber roof when the device is expanded and implanted;

an intermediate section comprising a spring-like section and operatively attached to the base section and the atrial dome in operable connection with the base frame and top section, wherein the intermediate section comprising a spring-like section is adapted to achieve non-elastic compression and generate a resultant biasing force;

a central cylinder valve support comprising a lower surface, the central cylinder valve support operatively attached to base section and comprising at least one prosthetic valve leaflet operatively attached therein, wherein the lower surface is located on or above the annular plane.

2. The device of claim 1, further comprising the at least one prosthetic valve leaflet attached within the central cylinder valve support at the lower surface of the central cylinder valve support.

3. The device of claim 1, further comprising the at least one prosthetic valve leaflet attached within the central cylinder valve support at a point that is located above the lower surface of the central cylinder valve support.

4. The device of claim 1, wherein the heart chamber comprises the left atrium and the native valve comprises the mitral valve comprising native leaflets.

5. The device of claim 1, further comprising the expanded and implanted device comprising no structural engagement presence in, or engagement with, with the native valve leaflets.

6. The device of claim 4, further comprising the expanded and implanted device comprising no structural presence in, or engagement with, one or more of the group consisting of:

the native mitral valve comprising native leaflets, the left ventricle, and a pulmonary artery.

7. The device of claim 1, wherein the atrial dome comprises a wire boundary.

10. The device of claim 1, the intermediate section further comprising a plurality of spring elements comprising springs or shock absorbers operationally connected between the base section and the atrial dome.

11. The device of claim 10, the spring-like section comprising one or more rigid wires operationally connected between the base section and the atrial dome.

12. The device of claim 10, the plurality of spring elements comprising an elastic or superelastic material.

13. The device of claim 12, the plurality of spring elements comprising nitinol.

9. The device of claim 9, wherein the atrial dome comprises a covered structure defined by a wire boundary.

8. The device of claim 9, wherein the atrial dome comprises an open structure defined by the wire boundary.

14. A method for preserving the functionality of a patient'"'"'s at least partially malfunctioning native heart valve with an implanted prosthetic heart valve device within a heart chamber comprising an annulus defining an annular plane, comprising:

providing a collapsible prosthetic heart valve device, including an anchoring structure comprising a base section having a lower surface, a top section and an intermediate section comprising a spring-like section, wherein the intermediate section is operationally connected between the base section and the top section;

providing a central cylinder valve support operationally attached to the lower surface of the base section and comprising prosthetic valve leaflets operationally attached therein;

expanding and implanting the prosthetic heart valve device within a single heart chamber wherein the heart chamber is at least partially protected from retrograde flow by the at least partially malfunctioning native valve, wherein at least a portion of the lower surface of the base section is disposed on the annular plane, and wherein the central cylinder valve support does not extend below the annular plane; and

preserving the remaining normal native functionality of the at least partially malfunctioning native valve with the expanded and implanted prosthetic heart valve device.

15. The method of claim 14, wherein the single chamber of the heart comprises the left atrium and the native valve is the mitral valve comprising native leaflets.

16. The method of claim 15, comprising ensuring the expanded and implanted prosthetic heart valve device has no structural presence in, or engagement with, at least one of the group consisting of:

the mitral valve comprising native leaflets, the patient'"'"'s left ventricle, and a pulmonary artery.

17. A method for preserving and supplementing the functionality of a patient'"'"'s at least partially malfunctioning native heart valve with an implanted prosthetic heart valve device within a heart chamber comprising an annulus defining an annular plane, comprising:

providing a collapsible prosthetic heart valve device, including an anchoring structure comprising a base section having a lower surface, a top section and an intermediate section comprising a plurality of spring elements, the spring elements of the intermediate section operationally connected between the base section and the top section;

providing a central cylinder valve support operationally attached to the lower surface of the base section and comprising prosthetic valve leaflets operationally attached therein;

expanding and implanting the prosthetic heart valve device within a single heart chamber wherein the heart chamber is at least partially protected from retrograde flow by the at least partially malfunctioning native valve, wherein at least a portion of the lower surface of the base section is disposed on the annular plane, and wherein the central cylinder valve support does not extend below the annular plane; and

preserving and supplementing the remaining normal native functionality of the at least partially malfunctioning native valve with the implanted prosthetic heart valve device.

18. The method of claim 17, wherein the single chamber of the heart comprises the left atrium and the native valve is the mitral valve.

19. The method of claim 18, further comprising ensuring the expanded and implanted prosthetic heart valve device has no structural presence in, or engagement with, at least one of the group consisting of:

the mitral valve comprising native leaflets, the patient'"'"'s left ventricle, and a pulmonary artery.

20. A method for preserving and supplementing any remaining native functionality of a patient'"'"'s at least partially malfunctioning native heart valve and replacing the heart valve functionality with an implanted prosthetic heart valve device with an implanted prosthetic heart valve device within a heart chamber comprising an annulus defining an annular plane, comprising:

providing a collapsible prosthetic heart valve device, including an anchoring structure comprising a base section having a lower surface, a top section and an intermediate section comprising a plurality of spring-like elements, the intermediate section operationally disposed between the base section and the top section;

providing a central cylinder valve support operationally attached to the lower surface of the base section and comprising prosthetic valve leaflets operationally attached therein;

expanding and implanting the prosthetic heart valve device within a single heart chamber wherein the heart chamber is at least partially protected from retrograde flow by the at least partially malfunctioning native valve, wherein at least a portion of the lower surface of the base section is disposed on the annular plane, and wherein the central cylinder valve support does not extend below the annular plane;

preserving and supplementing the remaining normal native functionality of the malfunctioning native valve with the implanted prosthetic heart valve device; and

completely replacing the native valve functionality when the native valve ceases to provide any normal native functionality.

21. The method of claim 20, wherein the single chamber of the heart is the left atrium and the native valve is the mitral valve comprising native leaflets.

22. The method of claim 21, further comprising ensuring the expanded and implanted prosthetic heart valve device has no structural engagement with at least one of the group consisting of:

the native mitral valve comprising leaflets, the patient'"'"'s left ventricle, and a pulmonary artery.