IP Library › Granted Patent US 12,636,146
Granted Patent B2
US 12,636,146 · App. 17/338,968 · Granted May 26, 2026

Heart chamber prosthetic valve implant with elevated valve section and single chamber anchoring for preservation, supplementation and/or replacement of native valve function

Inventor: Jeffrey W. Chambers (Maple Grove, MN)
Assignee: 4C Medical Technologies, Inc.
A61F2/2418A61F2/24A61F2/2409A61F2/2412A61F2/2442A61F2/2487A61F2/2445A61F2/2454A61F2/2463A61F2/2469A61F2210/0014A61F2230/0069A61F2250/0048
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Quick Facts
Patent No.
US 12,636,146
App. No.
17/338,968
Granted
May 26, 2026
Kind
B2
Abstract

Various embodiments of the present invention comprise a single-chamber collapsible and expandable prosthetic valve implant device with an elevated valve section and 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 (44)

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

a base section defining a base section lower surface;

an atrial dome that is configured to be in pressured engagement with a roof of the heart chamber when the device is expanded and implanted in the heart chamber;

an intermediate section that extends from the base section to the atrial dome; and

a valve support extending within an interior defined by the base, the atrial dome and the intermediate section, wherein:

the valve support defines:

a valve support lower surface; and

a height;

the valve support lower surface extends from the base section lower surface; and

the valve support:

includes at least one prosthetic valve leaflet that allows blood to flow therethrough in an antegrade direction while preventing blood flow therethrough in a retrograde direction; and

wherein the at least one prosthetic valve leaflet is attached to the valve support at a location along the height that is above the valve support lower surface.

2 . The device of claim 1 wherein the base section comprises a shape memory material.

3 . The device of claim 1 further comprising a material covering at least a portion of an outside surface of the base section.

4 . The device of claim 1 wherein the device, when expanded in the heart chamber, is configured to achieve a plurality of expanded configurations.

5 . The device of claim 1 wherein the heart chamber is a left atrium and the native valve is a mitral valve.

6 . The device of claim 1 wherein the heart chamber is a right atrium and the native valve is a tricuspid valve.

7 . The device of claim 1 wherein the device, when implanted in the heart chamber, is configured to have no structural engagement with the leaflets.

8 . The device of claim 5 wherein the device, when implanted in the heart chamber, is configured to have no structural engagement with the leaflets.

9 . The device of claim 5 , wherein the device, when implanted in the heart chamber, is configured to have no structural presence within a left ventricle.

10 . The device of claim 5 wherein the device, when implanted in the heart, is configured to have no structural presence within a pulmonary artery.

11 . A method for preserving functionality of a at least partially malfunctioning heart valve by implanting a prosthetic heart valve device within a heart chamber, the method comprising:

providing the device of claim 1 ;

expanding and implanting the device within the heart chamber; and

preserving remaining native functionality of the heart valve by implanting the device.

12 . The method of claim 11 wherein the heart chamber is a left atrium and the heart valve is a mitral valve comprising native leaflets.

13 . The method of claim 12 wherein the device, when implanted in the heart chamber, is configured to have no structural presence in, or engagement with, the mitral valve or with a left ventricle.

14 . The method of claim 11 wherein the device, when implanted in the heart chamber, is configured to have no structural presence in, or engagement with, a pulmonary artery.

15 . A method for replacing heart valve functionality of a heart valve by implanting a prosthetic heart valve device within a heart chamber, the method comprising:

providing the device of claim 1 ;

expanding and implanting the device within the heart chamber; and

replacing the heart valve functionality by implanting the device.

16 . The method of claim 15 wherein the heart chamber is a left atrium and the heart valve is a mitral valve comprising leaflets.

17 . The method of claim 16 wherein the device, when implanted in the heart chamber, is configured to have no structural engagement with the mitral valve or a left ventricle.

18 . The method of claim 15 wherein the device, when implanted in the heart chamber, is configured to have no structural presence in, or engagement with, a pulmonary artery.

19 . The device of claim 1 wherein the device, when expanded and implanted, is configured to sit in an annulus and pin back the leaflets.

20 . The device of claim 1 wherein the intermediate section comprises an expandable mesh.

21 . The device of claim 1 wherein the base section comprises a stent.

22 . The device of claim 20 wherein the base section comprises a stent.

23 . The device of claim 1 wherein the atrial dome comprises molded material.

24 . The device of claim 20 wherein the atrial dome:

comprises molded material; and

is connected to the expandable mesh.

25 . The device of claim 1 wherein the base section, when expanded and implanted, is configured to sit in an annulus.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 4, 2021
From: CHAMBERS, JEFFREY W.
To: 4C MEDICAL TECHNOLOGIES, INC
Reel/Frame 056439/0182 →
Continuity (5)
Continuation 15674041 · Aug 10, 2017
Provisional Application 62373560 · Aug 11, 2016
Provisional Application 62373541 · Aug 11, 2016
Provisional Application 62373551 · Aug 11, 2016
Related Publication 20210290383A1 · Sep 23, 2021
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