Suturing rings for implantable heart valve prosthesis

• US 20040015232A1
• Filed: 07/16/2002
• Published: 01/22/2004
• Est. Priority Date: 07/16/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shu, Mark C.S., Salazar, Luis A.
• Granted Patent: US 7,172,625 B2
• Time in Patent Office: Days
• US Class Current: 623/2.4
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: Y10S 623/902 Method of implanting

Abstract

Suturing rings and methods of use thereof facilitating initial implantation of new and replacement of dysfunctional tissue or mechanical heart valve mechanisms supported by the suturing ring are disclosed. The suturing ring annulus is adjustable to receive and engage the valve frame of the heart valve mechanism within the annulus. An interlocking mechanism applies restraint to fix the adjusted suturing ring annulus engaged against the valve frame to support the heart valve mechanism during chronic implantation. Sutures affixing the suturing ring to the valvar rim can be routed and entrapped between the suturing ring annulus and the valve frame when the suturing ring is restraint is applied. The restraint is released to replace a dysfunctional heart valve mechanism and reapplied when a new heart valve mechanism is fitted into the annulus.

Claims

1. A suturing ring adapted to support a heart valve mechanism having a valve frame and at least one occluder within a suturing ring annulus and to be surgically attached to a valvar rim of a living heart to form a heart valve prosthesis replacing a native heart valve comprising:

means for adjusting the suturing ring annulus to enable insertion and seating of the valve frame in the suturing ring annulus during initial implantation or replacement of the heart valve mechanism; and

means for interlocking the suturing ring annulus in seated engagement against the valve frame to retain the valve frame in the suturing ring annulus during chronic implantation of the heart valve prosthesis.

2. The suturing ring of claim 1, further comprising routing means for routing at least one suture sewn into the valvar rim between the suturing ring annulus and the valve frame to secure the suturing ring against the valvar rim.

3. The suturing ring of claim 2, wherein:

the suturing ring further comprises a stiffening band having an interior band sidewall defining the suturing ring annulus and an exterior band sidewall; and

the routing means comprises a suturing ring fabric disposed about at least the exterior band sidewall through which the suture is adapted to be sewn.

4. The suturing ring of claim 2, wherein:

the suturing ring further comprises a stiffening band having an interior band sidewall defining the suturing ring annulus and an exterior band sidewall; and

the routing means comprises at least one hole extending between the interior and exterior band sidewalls through which the suture is adapted to be routed.

5. The suturing ring of claim 2, wherein:

the suturing ring further comprises a stiffening band having an interior band sidewall defining the suturing ring annulus and an exterior band sidewall; and

the routing means comprises a suturing ring fabric disposed about at least the exterior band sidewall through which the suture is adapted to be sewn and at least one hole extending between the interior and exterior band sidewalls through which the suture is adapted to be routed.

6. The suturing ring of claim 2, wherein:

the suturing ring further comprises a stiffening band having an interior band sidewall defining the suturing ring annulus and an exterior band sidewall; and

the routing means comprise a plurality of spaced apart suture guides formed in the stiffening band to dispose a plurality of sutures spaced apart from one another and extending within the suturing ring annulus alongside the interior band sidewall.

7. The suturing ring of claim 6, wherein the plurality of spaced apart suture guides each comprise a hole extending between the interior and exterior band sidewalls through which the suture is adapted to be routed.

8. The suturing ring of claim 2, wherein:

the valve frame is formed with an outwardly extending valve frame flange;

the interior band sidewall is formed with at least one outwardly extending groove alongside at least one inwardly extending band flange adapted to seat the outwardly extending valve frame flange; and

the routing means comprise a plurality of spaced apart suture guides formed in the inwardly extending band flange to receive and dispose a plurality of sutures spaced apart from one another and extending within the suturing ring annulus alongside the interior band sidewall and between the outwardly extending groove and the outwardly extending valve frame flange.

9. The suturing ring of claim 8, wherein the suture guides each comprise a hole extending axially across the inwardly extending band flange through which a suture is adapted to be axially inserted.

10. The suturing ring of claim 8, wherein the suture guides each comprise a slotted hole extending across the inwardly extending band flange through which a suture is adapted to be laterally routed.

11. A suturing ring adapted to support a heart valve mechanism having a valve frame and at least one occluder and to be surgically attached to a valvar rim of a living heart to form a heart valve prosthesis replacing a native heart valve comprising:

a substantially cylindrical, split stiffening band having an exterior band sidewall and an interior band sidewall defining a suturing ring annulus, the stiffening band split to present generally opposed first and second band split ends separated by a gap, the stiffening band formed of a resilient material enabling the gap between the band split ends to be expanded or contracted by force applied to the band split ends to adjust the suturing ring annulus to bear against and support the valve frame of the heart valve mechanism; and

an interlocking restraint that extends between the band split ends adapted to be engaged in a surgical procedure in which the valve frame is inserted into the suturing ring annulus to fix the gap between the band split ends and inhibit separation of the band split ends apart sufficiently to release the valve frame from the annulus during chronic implantation.

12. The suturing ring of claim 11, wherein the restraint is further adapted to be selectively released in a surgical procedure to enable adjustment of the valve frame annulus to release the valve frame of a dysfunctional valve mechanism from the suturing ring annulus and to enable insertion of a replacement valve mechanism into the suturing ring annulus without surgically removing the suturing ring from the valvar rim.

13. The suturing ring of claim 12, wherein the restraint is selected from the group consisting of sutures, clamps, hooks, teeth, or buttons that can released even after chronic implantation so that a dysfunctional heart valve mechanism can be replaced.

14. The suturing ring of claim 12, wherein the restraint further comprises a first suture retainer adjacent the first band split end and a second suture retainer adjacent the second band split end, the first and second suture retainers adapted to be engaged by a suture during the surgical implantation of the suturing ring and heart valve mechanism.

15. The suturing ring of claim 12, wherein the restraint further comprises a first suture hole extending between the interior band sidewall and the exterior band sidewall adjacent to the first band split end and a second suture hole extending between the interior band sidewall and the exterior band sidewall adjacent to the first band split end, the first and second suture holes adapted to receive a surgical suture passed through the first and second suture holes and the suturing ring fabric overlying the first and second suture holes and tied off.

16. The suturing ring of claim 12, wherein the restraint further comprises a spring member extending between the first and second band split ends to tension the first and second band split ends when a valve housing is seated in the suturing ring annulus.

17. The suturing ring of claim 12, wherein the restraint further comprises a first hooking mechanism arranged on the first band split end and a second hooking mechanism arranged of the second mechanism, the first and second hooking mechanisms adjustably overlapping and engaging one another to enable selective adjustment of the sewing ring annulus.

18. The suturing ring of claim 12, wherein the restraint further comprises a strap member extending between the first and second band split ends and adapted be attached to or released from at least one of the first and second band split ends to enable selective adjustment of the sewing ring annulus.

19. The suturing ring of claim 11, wherein the restraint is selected from the group consisting of sutures, clamps, hooks, teeth, or buttons that can released even after chronic implantation so that a dysfunctional heart valve mechanism can be replaced.

20. The suturing ring of claim 11, wherein the restraint further comprises a first suture retainer adjacent the first band split end and a second suture retainer adjacent the second band split end, the first and second suture retainers adapted to be engaged by a suture during the surgical implantation of the suturing ring and heart valve mechanism.

21. The suturing ring of claim 11, wherein the restraint further comprises a first suture hole extending between the interior band sidewall and the exterior band sidewall adjacent to the first band split end and a second suture hole extending between the interior band sidewall and the exterior band sidewall adjacent to the first band split end, the first and second suture holes adapted to receive a surgical suture passed through the first and second suture holes and the suturing ring fabric overlying the first and second suture holes and tied off.

22. The suturing ring of claim 11, wherein the restraint further comprises a spring member extending between the first and second band split ends to tension the first and second band split ends when a valve housing is seated in the suturing ring annulus.

23. The suturing ring of claim 11, wherein the restraint further comprises a first hooking mechanism arranged on the first band split end and a second hooking mechanism arranged of the second mechanism, the first and second hooking mechanisms adjustably overlapping and engaging one another to enable selective adjustment of the sewing ring annulus.

24. The suturing ring of claim 11, wherein the restraint further comprises a strap member extending between the first and second band split ends and adapted be attached to or released from at least one of the first and second band split ends to enable selective adjustment of the sewing ring annulus.

25. The suturing ring of claim 11, wherein:

the valve frame is formed with an outwardly extending valve frame flange;

the interior band sidewall is formed with at least one outwardly extending groove adapted to seat the outwardly extending valve frame flange.

26. The suturing ring of claim 11, wherein the split stiffening band has a predetermined axial width adapted to be received with in a U-shaped channel of the outer wall of a valve frame, whereby the valve frame is seated in the suturing ring annulus when the restraint is engaged.

27. The suturing ring of claim 11, further comprising a suturing ring fabric sewn to the stiffening band around at least the exterior band sidewall, and wherein the restraint is further adapted to be selectively released in a surgical procedure to enable adjustment of the valve frame annulus to release the valve frame of a dysfunctional valve mechanism from the suturing ring annulus and to enable suturing together of the surgically attached suturing ring to an integral suturing ring of a replacement heart valve prosthesis seated in or bearing against the suturing ring annulus without surgically removing the attached suturing ring from the valvar rim.

28. A method of implanting a suturing ring adapted to support a heart valve mechanism having a valve frame and at least one occluder within a suturing ring annulus and to be surgically attached to a valvar rim of a living heart to form a heart valve prosthesis replacing a native heart valve comprising:

inserting the valve frame into the suturing ring annulus;

adjusting the suturing ring annulus to seat the valve frame within the suturing ring annulus;

operating an interlocking mechanism to apply restraint to the adjusted suturing ring annulus in seated engagement against the valve frame to retain the valve frame in the suturing ring annulus during chronic implantation of the heart valve prosthesis; and

suturing the suturing ring to the valvar rim.

29. The method of claim 28, further comprising:

removing a dysfunctional valve mechanism from the suturing ring annulus by;

operating the interlocking mechanism to release the applied restraint;

unseating the heart valve frame from the suturing ring annulus; and

removing the dysfunctional heart valve prosthesis from the suturing ring annulus; and

inserting the valve frame of a replacement new heart valve mechanism into the suturing ring annulus;

adjusting the suturing ring annulus to seat the valve frame within the suturing ring annulus; and

operating the interlocking mechanism to apply restraint to the adjusted suturing ring annulus in seated engagement against the valve frame to retain the valve frame in the suturing ring annulus during chronic implantation of the replacement heart valve prosthesis.

30. The method of claim 28, further comprising:

removing a dysfunctional valve mechanism from the suturing ring annulus by;

operating the interlocking mechanism to release the applied restraint;

unseating the heart valve frame from the suturing ring annulus; and

removing the dysfunctional heart valve prosthesis from the suturing ring annulus; and

attaching a replacement new heart valve prosthesis comprising a valve mechanism and integral suturing ring to the surgically attached suturing ring by suturing the integral suturing ring to the surgically attached suturing ring.

31. A method of implanting a suturing ring adapted to support a heart valve mechanism having a valve frame and at least one occluder within a suturing ring annulus and to be surgically attached to a valvar rim of a living heart to form a heart valve prosthesis replacing a native heart valve comprising:

forming the suturing ring having a substantially cylindrical, split stiffening band having an exterior band sidewall and an interior band sidewall defining a suturing ring annulus, the stiffening band split to present generally opposed first and second band split ends separated by a gap, the stiffening band formed of a resilient material;

inserting the valve frame into the suturing ring annulus while adjusting the gap to thereby adjust the suturing ring annulus to seat the valve frame within the suturing ring annulus;

operating an interlocking mechanism to apply restraint to the adjusted suturing ring annulus in seated engagement against the valve frame to retain the valve frame in the suturing ring annulus during chronic implantation of the heart valve prosthesis; and

suturing the suturing ring to the valvar rim.

32. The method of claim 31, wherein the step of operating an interlocking mechanism comprises suturing the generally opposed first and second band split ends together with an interlocking suture.

33. The method of claim 31, further comprising welding the interlocking suture ends together to prevent release.

34. The method of claim 31, further comprising:

removing a dysfunctional valve mechanism from the suturing ring annulus by;

operating the interlocking mechanism to release the applied restraint;

unseating the heart valve frame from the suturing ring annulus; and

removing the dysfunctional heart valve prosthesis from the suturing ring annulus; and

inserting the valve frame of a replacement new heart valve mechanism into the suturing ring annulus;

adjusting the suturing ring annulus to seat the valve frame within the suturing ring annulus; and

operating the interlocking mechanism to apply restraint to the adjusted suturing ring annulus in seated engagement against the valve frame to retain the valve frame in the suturing ring annulus during chronic implantation of the replacement heart valve prosthesis.

35. The method of claim 31, further comprising:

removing a dysfunctional valve mechanism from the suturing ring annulus by;

operating the interlocking mechanism to release the applied restraint;

unseating the heart valve frame from the suturing ring annulus; and

removing the dysfunctional heart valve prosthesis from the suturing ring annulus; and

attaching a replacement new heart valve prosthesis comprising a valve mechanism and integral suturing ring to the surgically attached suturing ring by suturing the integral suturing ring to the surgically attached suturing ring.

36. A method of implanting a suturing ring adapted to support a heart valve mechanism having a valve frame and at least one occluder within a suturing ring annulus and to be surgically attached to a valvar rim of a living heart to form a heart valve prosthesis replacing a native heart valve comprising:

suturing at least one suture into valvar rim tissue;

routing a segment of the at lease one suture through the suturing ring annulus;

situating the suturing ring against the valvar rim; and

inserting the valve frame into the suturing ring annulus, whereby the segment of the suture is disposed between the suturing ring annulus and the valve frame.

37. The method of claim 36 further comprising the steps of;

adjusting the suturing ring annulus to seat the valve frame within the suturing ring annulus; and

interlocking the adjusted suturing ring annulus in seated engagement against the valve frame and the segment of the suture to secure the suturing ring against the valvar rim and to retain the valve frame in the suturing ring annulus during chronic implantation of the heart valve prosthesis.

38. The method of claim 36, wherein the suturing and routing steps further comprise suturing a running suture in a plurality of loops through the suturing ring annulus and a plurality of sites of the valvar rim tissue, whereby a plurality of suture segments are disposed between the suturing ring annulus and the valve frame.

39. The method of claim 38, further comprising the step of attaching the ends of the running suture extending from an entrapped segment of the running suture to the suturing ring.

40. The method of claim 36, wherein:

the suturing step further comprise suturing a plurality of sutures through a plurality of valvar rim sites;

the routing step further comprises routing the plurality of sutures through the suturing ring annulus, whereby a plurality of suture segments are disposed between the suturing ring annulus and the valve frame.

41. The method of claim 40, further comprising the step of attaching an end of each suture extending from the entrapped segment of each suture to the suturing ring.

42. The method of claim 40, wherein the suturing ring is formed with suture guides extending through the suturing ring, and wherein the routing step further comprises routing each suture segment through a suture guide and around a segment of the suturing ring, and further comprising:

tying a hitch in each suture extending around the segment of the suturing ring.

43. The method of claim 40, wherein the suturing ring is formed with suture guides, and the routing step further comprises routing each suture segment through a suture guide.

44. The method of claim 36, wherein the suturing ring is formed with suture guides, and the routing step further comprises routing each suture segment through a suture guide.