Annuloplasty repair devices, systems and methods

• US 10,357,365 B2
• Filed: 03/07/2016
• Issued: 07/23/2019
• Est. Priority Date: 03/07/2016
• Status: Active Grant

• Current Assignee: Serca Biomedical, LLC
• Original Assignee: Serca Biomedical, LLC
• Inventors: Kuehn, Stephen
• Primary Examiner(s): Stransky, Katrina M
• Application Number:
  US15/062,908
• Publication Number:
  US 20170252162A1
• Time in Patent Office: 1,233 Days
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

An annuloplasty prosthesis and delivery system for implanting the prosthesis adjacent an annulus of a heart valve having leaflets for adjusting the annulus to improve valve function includes a ring prosthesis made of shape memory material and having tissue attachment members which attach to the annulus in the atrium and commissural legs extending from the ring between the leaflets and secure against the underside of the valve in the ventricle. The prosthesis is carried via an orientation loop and attaches to the heart tissue such that when the prosthesis is manipulated and relaxed the annulus is adjusted to reduce or eliminate regurgitation.

Claims

1. An annuloplasty prosthesis for implantation adjacent an annulus of a heart valve of a heart, the annulus having at least an anterior and posterior aspect adjacent anterior and posterior leaflets, respectively, the prosthesis comprising:

a closed ring body made of a single piece of shape memory material and having a central opening defined entirely by an inner perimeter edge of the ring body, the ring body comprising;

an anterior portion and a posterior portion shaped to conform to, and for implantation adjacent, the anterior and posterior aspects of the annulus, respectively; and

at least a first tissue attachment member having a point configured to secure into tissue of the annulus and integrally connected to and extending from the ring body; and

at least one commissural leg integrally connected to and extending from the ring body, the at least one commissural leg having a total length greater than a total length of the first tissue attachment member.

2. The prosthesis of claim 1 where the prosthesis is a unitary body made of a single piece of Nitinol.

3. The prosthesis of claim 1 where the at least a first tissue attachment member is curved.

4. The prosthesis of claim 3 where the at least a first tissue attachment member is configured to be attached to the valve annulus via relaxation-after-over-expression of the ring body.

5. The prosthesis of claim 1 where the at least one commissural leg is configured such that when the prostheses is implanted, the commissural leg will be located near the junction of the anterior and posterior aspects of the annulus and within a ventricle of the heart while the ring body is positioned in an atrium of the heart.

6. The prosthesis of claim 1 where the at least a first tissue attachment member is positioned at the anterior portion, the prosthesis further comprising a second tissue attachment member positioned at the posterior portion, the first commissural leg configured to insert into an anterolateral commissure formed by the leaflets and a second commissural leg extending from the ring body and configured to insert into a posteromedial commissure formed by the leaflets.

7. The prosthesis of claim 1 where the at least a first tissue attachment member extends downward from the ring body, the at least one commissural leg extending downward from the ring body, the commissural leg configured to extend between the anterior and posterior leaflets.

8. The prosthesis of claim 1 where the ring body is saddle-shaped such that a lower-most portion of the at least a first tissue attachment member is positioned above a lower-most portion of the at least one commissural leg extending downward from the ring body.

9. The prosthesis of claim 1 where the at least a first tissue attachment member is a hooked barb having a medially directed point and positioned at the anterior portion of the ring body, the ring body further comprising a second tissue attachment member having a medially directed point and positioned at the anterior portion of the ring body, the medially directed points directed toward each other.

10. The prosthesis of claim 1 where the ring body further comprises a control port passing through the ring body, the control port configured to receive a control pin of a prosthesis delivery system.

11. The prosthesis of claim 10 where control port passes through the ring body at a tissue attachment area.

12. An annuloplasty prosthesis for implantation adjacent an annulus of a heart valve of a heart, the annulus having at least an anterior and posterior aspect adjacent anterior and posterior leaflets, respectively, the prosthesis comprising:

a completely closed ring body comprising an anterior portion and a posterior portion shaped to conform to, and for implantation adjacent, the anterior and posterior aspects of the annulus, respectively, a central opening defined entirely by an inner perimeter edge of the ring body; and

at least a first self-folding commissural leg integrally connected to and extending from the ring body.

13. The prosthesis of claim 12 where the prosthesis is a unitary article made of a single piece of shape memory material, the first commissural leg configured such that when the prostheses is implanted, the commissural leg is positioned within a ventricle of the heart while the ring body is positioned in an atrium of the heart.

14. The prosthesis of claim 12 where a plurality of commissural legs extend from the ring body and are configured such that when the prosthesis is implanted, the legs are located near the junctions of the anterior and posterior aspects of the annulus and within the ventricle.

15. The prosthesis of claim 12 where the anterior portion includes at least a first tissue attachment member and the posterior portion includes at least a second tissue attachment member, each tissue attachment member comprising a barb having a medially directed point.

16. The prosthesis of claim 12 where the ring body is made of a metal shape memory material, the ring body configured to express outwardly in an anterior-posterior direction.

17. The prosthesis of claim 12 where a first pair of commissural legs integrally extend from the ring body opposite a second pair of commissural legs, a pair of tissue attachment members each having a point configured to secure into tissue of the annulus and integrally extend from the ring body opposite a second pair of tissue attachment members each having a point configured to secure into tissue of the annulus, the commissural legs configured for positioning between the leaflets.

18. The prosthesis of claim 12 further comprising at least one tissue attaching member having a point configured to secure into tissue of the annulus and integrally connected to the ring body, the tissue attaching member extending downward from the ring body.

19. The prosthesis of claim 12 having a second commissural leg extending from the ring body at a position opposite the first commissural leg, a height dimension spanning from a lowermost aspect of the first commissural leg to an uppermost aspect of the ring body and a width dimension spanning from an outer aspect of the first commissural leg to an outer aspect of the second commissural leg, the height dimension having a measure substantially less than a measure of the width dimension when the prosthesis is in a relaxed state.

20. The prosthesis of claim 12 where the first commissural leg is configured to self-fold upon release from a guide and after release from a delivery catheter.

21. The prosthesis of claim 12 further comprising means for attaching the ring body into tissue of the annulus.

22. The prosthesis of claim 21 where the means for attaching the ring body into tissue of the annulus includes a point configured to secure into tissue.

23. An annuloplasty prosthesis for percutaneous implantation via a catheter adjacent an annulus of a heart valve of a heart, the annulus having at least an anterior and posterior aspect adjacent anterior and posterior leaflets, respectively, the prosthesis comprising:

a ring body comprising an anterior portion and a posterior portion shaped to conform to, and for implantation adjacent, the anterior and posterior aspects of the annulus, respectively; and

at least a first commissural leg integrally connected to and extending from the ring body, the first commissural leg configured to self-fold after release from the catheter.

24. The prosthesis of claim 23 where the first commissural leg is configured to sit within a guidehead and contract and/or expand upon sliding of the guidehead.

25. The prosthesis of claim 23 where the prosthesis is a unitary article made of a single piece of shape memory material, the first commissural leg configured such that when the prostheses is implanted, the first commissural leg is positioned within a ventricle of the heart.

26. The prosthesis of claim 25 where the anterior aspect includes at least a first tissue attachment member having a point configured to secure into tissue of the annulus and the posterior portion includes at least a second tissue attachment member having a point portion configured to secure into tissue of the annulus, the prosthesis further including at least a second commissural leg configured to self-fold after release from a guidehead such that when implanted is positioned within the ventricle.

27. The prosthesis of claim 25 where the first commissural leg is positioned within a ventricle of the heart while the ring body is positioned in an atrium of the heart.

28. The prosthesis of claim 23 further comprising a second commissural leg extending from the ring body and configured to self-fold after release from the catheter, the first and second commissural legs positioned adjacent each other on the ring body and configured to sit within a guidehead and self-fold in opposite directions upon sliding of the guidehead.

29. An annuloplasty prosthesis for implantation adjacent an annulus of a heart valve of a heart, the annulus having at least an anterior and posterior aspect adjacent anterior and posterior leaflets, respectively, the prosthesis comprising:

a completely closed ring body comprising an anterior portion and a posterior portion shaped to conform to, and for implantation adjacent, the anterior and posterior aspects of the annulus, respectively, a central opening defined entirely by an inner perimeter edge of the ring body; and

at least a first self-folding commissural leg integrally connected to and extending from the ring body and where the commissural leg is a non-tissue-penetrating leg.

30. The prosthesis of claim 29 where the commissural leg includes a smooth surface configured to contact with an underside of the leaflet or a sub annular groove of the valve.

31. An annuloplasty prosthesis being a unitary article made of a single piece of shape memory material for implantation adjacent an annulus of a heart valve of a heart, the annulus having at least an anterior and posterior aspect adjacent anterior and posterior leaflets, respectively, the prosthesis comprising:

a closed ring body made of a single piece of shape memory material and having a central opening defined entirely by an inner perimeter edge of the ring body, the ring body comprising an anterior portion and a posterior portion shaped to conform to, and for implantation adjacent, the anterior and posterior aspects of the annulus, respectively; and

at least one commissural leg integrally connected to and extending from the ring body, the at least one commissural leg configured such that when the prostheses is implanted, the commissural leg locates near the junction of the anterior and posterior aspects of the annulus and within a ventricle of the heart while the ring body is positioned in an atrium of the heart.