Devices, systems, and methods for reshaping a heart valve annulus

• US 9,861,475 B2
• Filed: 08/12/2009
• Issued: 01/09/2018
• Est. Priority Date: 09/20/2000
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Machold, Timothy R., Rahdert, David A., Macoviak, John A., Chang, Robert T., Soss, Rick A.
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US12/462,956
• Publication Number:
  US 20090306622A1
• Time in Patent Office: 3,072 Days
• Field of Search: 600 37, 623 236, 623 237, 623 238, 623 21, 606151, 606157, 606158
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• 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 2/2445 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Devices, systems, and methods employ an implant that is sized and configured to attach to the annulus of a dysfunctional heart valve annulus. In use, the implant extends across the major axis of the annulus above and/or along the valve annulus. The implant reshapes the major axis dimension and/or other surrounding anatomic structures. The implant restores to the heart valve annulus and leaflets a more functional anatomic shape and tension. The more functional anatomic shape and tension are conducive to coaptation of the leaflets during systole, which, in turn, reduces regurgitation. The implant improves function to the valve, without surgically cinching, resecting, and/or fixing in position large portions of a dilated annulus, or without the surgical fixation of ring-like structures.

Claims

1. A method of treating a heart valve having a native heart valve annulus, valve leaflets and valve leaflet commissures positioned on opposite ends of a major axis of the heart valve annulus, the method comprising:

introducing an implant into a chamber of the heart valve, the implant having one or more rails extending between a first strut and a second strut,

and

deploying the implant

by engaging the valve leaflet commissures on opposite ends of the major axis of the heart valve annulus with the first and second struts so as to anchor the implant by a compressive loading of the one or more rails in a direction along the major axis so as to repair, replace or supplement the native heart valve with the implant,

wherein the implant anchors by engaging internal cardiac tissues without penetrating or engaging an outer epicardial surface and the one or more rails extend in a direction along the major axis.

2. The method of claim 1

wherein introducing the implant includes carrying the implant in a collapsed configuration within a sheath during intravascular deliver to the heart valve annulus, and withdrawing the sheath to deliver the implant at the heart valve annulus.

3. The method of claim 1

wherein introducing the implant further comprises advancing a catheter along an intravascular path, the catheter having a column strength to maintain force on the first strut during deployment.

4. The method of claim 1 wherein deploying the implant includes placing the first strut into contact with tissue at a first native valve leaflet commissure and subsequently placing the second strut into contact with tissue at a second native valve leaflet commissure while the one or more rails urges the first and second struts away from each other so as to elongate the major axis of the native heart valve after deployment.

5. The method of claim 1 further comprising:

outwardly displacing tissue along the major axis of the heart valve annulus thereby reshaping the native mitral heart valve annulus to improve coaptation of the native valve.

6. The method of claim 1 wherein the implant further comprises a pseudo-annulus that replaces valve function of the native valve annulus.

7. The method of claim 1 wherein the implant further comprises a neoleaflet element coupled to the one or more rails that supplements or replaces the native valve annulus when deployed.

8. The method of claim 1 wherein the one or more rails define a fabric covered bridge structure that supplements or replaces the native valve annulus when deployed.

9. The method of claim 1 wherein the implant is foldable between a delivery configuration and a deployed configuration such that deploying the implant comprises unfolding the implant.

10. The method of claim 9 wherein unfolding the implant comprises moving one or more tether or wire loops engaged with the implant.

11. The method of claim 1 wherein the rail is elastic such that the implant is movable to an elastically loaded state, wherein deploying the implant comprises:

prior to the elastic body being moved to the elastically loaded state of net compression, maintaining force on the first strut to elastically inwardly compress the elastic body while subsequently placing the second strut into contact with tissue at or near the second valve commissure to place the elastic rail under compressive load.

12. The method of claim 11, wherein the rail is defined in a shape so as to provide a spring constant when under a compressive load applied between the first and second struts thereby providing compliance to allow the implant to adapt to tissue morphology during use.

13. The method of claim 1, wherein the one or more rails circumscribe the native heart annulus within the chamber in which the heart valve is located.

14. The method of claim 13 wherein the native heart valve comprises a mitral valve or a tricuspid valve.

15. The method of claim 14, further comprising:

establishing an intravascular path that extends from a right atrium through a septum into the left atrium.

16. A method of treating a heart valve having a native heart valve annulus with valve leaflets and valve leaflet commissures on opposite ends of a major axis of the heart valve annulus, the method comprising:

introducing an implant into a chamber of the heart valve, the implant having one or more rails extending between opposing curvilinear engagement surfaces, the one or more rails sized and configured to extend between the opposing curvilinear engagement surfaces;

deploying the implant so as to engage the valve leaflet commissures on opposite ends of the major axis of the heart valve annulus with the opposing curvilinear engagement surfaces, respectively;

anchoring the implant within the native heart valve annulus by a compressive loading of the one or more rails while opposing curvilinear surfaces are engaged with the opposing valve leaflet commissures, wherein the implant anchors by engaging internal tissues without penetrating or engaging an outer epicardial surface and the one or more rails extending in a direction along the major axis; and

repairing, replacing or supplementing the native heart valve annulus with the implant.

17. The method of claim 16, wherein the one or more rails are defined within a bridge structure that extends about the native heart annulus within the chamber in which the heart valve is located.

18. The method of claim 16, wherein anchoring comprising engaging the valve leaflet commissures with the opposing curvilinear engagement surfaces such that each curvilinear surface engages tissue within the atrium above the commissure and engages tissue within a ventricle below the commissure.

19. The method of claim 16, wherein the implant is foldable between a collapsed configuration for intravascular delivery and an expanded configuration for deployment such that deploying the implant comprises unfolding the implant by moving one or more tethers or wire loops engaged with the implant.

20. The method of claim 16, wherein the implant comprises a fabric covered bridge structure supported by the one or more rails, the fabric covered bridge structure including one or more neo-leaflets that supplement or replace function of the native valve annulus when deployed.

21. A method of treating a heart valve having a native heart valve annulus, the annulus having a major axis and a minor axis, valve leaflets and valve leaflet commissures positioned on opposite ends of a major axis, the method comprising:

introducing an implant into a chamber of the heart valve, the implant having one or more rails extending between a first strut and a second strut, the one or more rails having a spring constant that, when the one or more rails are compressed, urges the first strut and the second strut away from each other; and

deploying the implant by engaging the implant with the annulus with the one or more rails above the native heart valve and the first and second struts engaging tissue at the lengthwise ends of the major axis in a compressed condition such that the first and second struts are urged away from each other to stretch the annulus lengthwise along its major axis while allowing the sides of the annulus to approach each other along the minor axis.