Heart valve prosthesis anchoring device and methods

• US 8,840,664 B2
• Filed: 06/14/2012
• Issued: 09/23/2014
• Est. Priority Date: 06/15/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Karapetian, Emil, Okos, Chris J., Winston, Matthew T.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US13/517,810
• Publication Number:
  US 20120323317A1
• Time in Patent Office: 831 Days
• Field of Search: 623/1.24, 623/2.26, 623/2.1, 623/2.11, 623/2.14, 623/2.17, 623/2.34, 623 236- 24, 623/2.15
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Apparatus and methods for securing heart valve repair or replacement prostheses in or near the heart. The apparatus and methods are particularly well suited for traditional surgery or minimally invasive surgery. The invention secures a heart valve repair or replacement prosthesis in place while lowering surgical exposure. The invention improves the ease of implantation because it reduces the number of surgical knots a clinician would normally tie in the limited space in and around the heart.

Claims

1. A knotless heart valve prosthesis, comprising:

a lower segmented ring having an implanted size that can be collapsed to a smaller size for passage through an annulus, the lower segmented ring comprising three separate segments arranged in a circumferential array with gaps therebetween;

an upper securing ring;

a prosthetic heart valve connected to the securing ring; and

a plurality of elongated flexible connection members extending upward from the lower segmented ring through mating apertures formed in the securing ring so as to couple the two rings together and clamp a valve annulus therebetween.

2. The prosthesis of claim 1, further including a plurality of protruding members that extend generally radially outward from the lower segmented ring that help anchor the heart valve to the valve annulus.

3. The prosthesis of claim 1, wherein the lower segmented ring includes rows of teeth on an upper surface thereof that help anchor the heart valve to the valve annulus.

4. The prosthesis of claim 1, wherein the connection members are more closely spaced at the lower segmented ring than at the securing ring.

5. The prosthesis of claim 1, further including flexible links joining the three separate segments of the lower segmented ring.

6. The prosthesis of claim 1, wherein the connection members comprise elongate strips with ratcheting teeth, and the mating apertures in the securing ring include ratchet pawls that engage the ratchet teeth on the connection members.

7. The prosthesis of claim 1, wherein the connection members comprise sutures, and the mating apertures in the securing ring comprise suture clamps.

8. The prosthesis of claim 1, wherein the securing ring has an undulating contour with three axially elevated peaks intermediate three axial valleys, and wherein the lower segmented ring mimics the undulating contour of the securing ring and has three segments that correspond to the three axially valleys of the securing ring, and wherein there are at least two connection members extending upward from each segment of the lower segmented ring.

9. A knotless aortic heart valve prosthesis, comprising:

a prosthetic heart valve having a securing ring extending outward from an inflow end thereof, the securing ring having an undulating contour with three outwardly projecting lobes intermediate three radially inward relief areas, the relief areas defining axial peaks and the lobes defining axial valleys, the securing ring having apertures therethrough;

a lower segmented ring smaller in circumference than the securing ring and having an undulating shape that mimics the undulating contour of the securing ring, the lower segmented ring comprising three separate segments arranged in a circumferential array with gaps therebetween; and

a plurality of elongated flexible connection members extending upward from the lower segmented ring through the apertures formed in the securing ring so as to couple the two rings together and clamp a valve annulus therebetween.

10. The prosthesis of claim 9, further including a plurality of protruding members that extend generally radially outward from the lower segmented ring that help anchor the heart valve to the valve annulus.

11. The prosthesis of claim 9, wherein the lower segmented ring includes rows of teeth on an upper surface thereof that help anchor the heart valve to the valve annulus.

12. The prosthesis of claim 9, wherein the connection members are more closely spaced at the lower segmented ring than at the securing ring.

13. The prosthesis of claim 9, further including flexible links joining the three separate segments of the lower segmented ring.

14. The prosthesis of claim 9, wherein the connection members comprise elongate strips with ratcheting teeth, and the apertures in the securing ring include ratchet pawls that engage the ratchet teeth on the connection members.

15. The prosthesis of claim 9, wherein the connection members comprise sutures, and the apertures in the securing ring comprise suture clamps.

16. A knotless heart valve prosthesis, comprising:

a lower segmented ring having an implanted size that can be collapsed to a smaller size for passage through an annulus;

an upper securing ring having an undulating contour with three axially elevated peaks intermediate three axial valleys, and wherein the lower segmented ring mimics the undulating contour of the securing ring and has three segments that correspond to the three axially valleys of the securing ring;

a prosthetic heart valve connected to the securing ring; and

a plurality of elongated flexible connection members extending upward from the lower segmented ring through mating apertures formed in the securing ring so as to couple the two rings together and clamp a valve annulus therebetween, and wherein there are at least two connection members extending upward from each segment of the lower segmented ring.

17. The prosthesis of claim 16, further including a plurality of protruding members that extend radially outward from the lower segmented ring that help anchor the heart valve to the valve annulus.

18. The prosthesis of claim 16, wherein the lower segmented ring includes rows of teeth on an upper surface thereof that help anchor the heart valve to the valve annulus.

19. The prosthesis of claim 16, wherein the connection members comprise elongate strips with ratcheting teeth, and the apertures in the securing ring include ratchet pawls that engage the ratchet teeth on the connection members.

20. The prosthesis of claim 16, wherein the connection members comprise sutures, and the mating apertures in the securing ring comprise suture clamps.