Devices, systems and methods for repairing lumenal systems

• US 10,449,046 B2
• Filed: 08/06/2014
• Issued: 10/22/2019
• Est. Priority Date: 09/22/2011
• Status: Active Grant

• Current Assignee: MEHR Medical LLC
• Original Assignee: Transmural Systems LLC
• Inventors: Rafiee, Nasser
• Primary Examiner(s): Yabut, Diane D
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US14/453,478
• Publication Number:
  US 20150039083A1
• Time in Patent Office: 1,903 Days
• Field of Search: 623 21, 623 211, 623 218, 623 111
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

The disclosure provides systems and related methods for delivering a prosthesis to a target location. Various embodiments of useful valve prostheses are also disclosed.

Claims

1. A valvular prosthesis that is implantable over a native valve annulus, comprising:

a) a main circumferential frame, substantially covered by a curved membrane, having a supra annular frame portion and a sub annular frame portion, wherein, upon deployment into a native valve location, the supra annular frame portion rests above a valve annulus over a native valve leaflet and the sub annular frame portion extends downwardly;

b) at least one deployable spring-loaded anchor attached to the main circumferential frame, wherein the at least one deployable anchor includes;

an elongate body formed from a nickel-titanium alloy shape memory wire material formed into an elongate loop having a first end and a second free end, the free end having a rounded tip, and being configured to rest against native cardiac tissue; and

at least one coil-shaped stress relief loop formed from said nickel-titanium alloy shape memory wire connecting the main circumferential frame to the first end of the elongate body, said at least one coil-shaped stress relief loop being configured and arranged to urge said elongate body to swing outwardly along an arcuate path about said at least one coil-shaped stress relief loop toward native cardiac tissue, wherein said at least one coil-shaped stress relief loop is configured to deflect and absorb bending stress along its length when said elongate body is forced inwardly to permit said elongate body of said at least one deployable anchor to be fully collapsed without fracturing said nickel-titanium alloy shape memory wire;

c) at least one guiding tether, wherein said at least one coil-shaped stress relief loop is configured and arranged to serve as a guide eyelet configured and arranged to receive the at least one guiding tether, and wherein said at least one guiding tether is configured and arranged such that when received by the at least one coil-shaped stress relief loop, said at least one guiding tether can hold the at least one deployable anchor in an undeployed position;

d) a plurality of counter fixation retainers disposed on the supra annular frame portion of the prosthesis, wherein at least two of the counter fixation retainers are configured and arranged to engage a native tissue wall proximate opposing native commissures,

wherein the prosthesis is configured and arranged to expand outwardly toward the commissures of the valve during implantation and is configured and arranged to self-align in the valve opening.

2. The prosthesis of claim 1, wherein said free end of said at least one deployable anchor is configured to deploy against a portion of a native left ventricular site.

3. The prosthesis of claim 2, wherein said at least one deployable anchor includes at least two deployable anchors said at least two deployable anchors being configured and arranged to self-expand against the left ventricle under force applied by said coil-shaped stress relief loops to help hold the prosthesis in place.

4. The prosthesis of claim 3, wherein said at least two deployable anchors includes three deployable anchors, said three deployable anchors being configured and arranged to self-expand against the left ventricle to help hold the prosthesis in place.

5. The prosthesis of claim 4, wherein two of the three deployable anchors are configured and arranged to self-expand laterally into the ventricle near the middle of the mitral annulus, and the third deployable anchor is configured and arranged to self-expand toward a location underneath a central region of the posterior mitral annulus.

6. The prosthesis of claim 3, wherein the main circumferential frame of the prosthesis includes a third deployable anchor that is configured and arranged to self-expand toward a location underneath a central region of the posterior mitral annulus.

7. The prosthesis of claim 6, wherein the curved membrane is stretched over the third deployable anchor.

8. The prosthesis of claim 7, wherein the curved membrane of the prosthesis defines a curved plane that stretches from above the mitral annulus proximate the periphery of the mitral annulus and curves downwardly into the left ventricle and bends upwardly to contact the underside of a central posterior region of the mitral annulus.

9. The prosthesis of claim 1, wherein the main circumferential frame includes at least one perimeter wire loop that traverses the perimeter of the curved membrane.

10. The prosthesis of claim 9, wherein the at least one perimeter wire loop forms a saddle shape when the prosthesis is deployed to match a saddle shape of a native mitral annulus in which the prosthesis is configured to be implanted.

11. The prosthesis of claim 9, wherein the main circumferential frame includes an outer perimeter structural wire attached to an inner circumferential loop, wherein the at least one deployable anchor is attached to the inner circumferential loop.

12. The prosthesis of claim 11, wherein the at least one coil-shaped stress relief loop is disposed in a sub annular location.

13. The prosthesis of claim 11, wherein the outer perimeter structural wire extends outwardly laterally beyond the inner circumferential loop to form crescent shaped frames on each side of the prosthesis to facilitate positioning of the prosthesis upon installation.

14. The prosthesis of claim 1, wherein one of the counter fixation retainers and the coil-shaped stress relief loop are formed from the same length of nickel-titanium alloy shape memory wire.

15. The prosthesis of claim 1, wherein the main circumferential frame is formed from nickel-titanium alloy shape memory wire.

16. The prosthesis of claim 1, further comprising a first attachment point disposed in a central region of the sub annular frame portion and configured to removably receive a first control rod of a delivery system.

17. The prosthesis of claim 16, further comprising a second attachment point disposed in a central posterior region of the supra annular frame portion and configured to removably receive a second control rod of the delivery system.

18. The prosthesis of claim 1, wherein the prosthesis is shaped to fit into a native tricuspid valve annulus.

19. The prosthesis of claim 1, wherein the prosthesis is shaped to fit into a native mitral valve annulus.

20. The prosthesis of claim 1, wherein the at least one deployable anchor can be permitted to expand outwardly when the at least one guiding tether is loosened.