HEART VALVE PROSTHESIS ANCHORING DEVICE AND METHODS

• US 20120323317A1
• Filed: 06/14/2012
• Published: 12/20/2012
• Est. Priority Date: 06/15/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Karapetian, Emil, Okos, Chris, Winston, Matthew
• Granted Patent: US 8,840,664 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• 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;

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 segmented ring through mating apertures formed in the securing ring so as to couple the two rings together and clamp a valve annulus therebetween, thereby securing the heart valve to the valve annulus without sutures.

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 lower segmented ring comprises three separate segments arranged in a circumferential array with gaps therebetween.

5. The prosthesis of claim 4, 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 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 generally 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 shape of the securing ring; and

a plurality of elongated flexible connection members extending upward from the segmented ring through the apertures formed in the securing ring so as to couple the two rings together and clamp a valve annulus therebetween, thereby securing the heart valve to the valve annulus without sutures.

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 lower segmented ring comprises three separate segments arranged in a circumferential array with gaps therebetween.

13. The prosthesis of claim 12, 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 mating apertures in the securing ring comprise suture clamps.

16. A method for implanting an aortic heart valve prosthesis comprising the steps of:

inserting a segmented lower ring downward through an aortic annulus from the atrial to ventricular side, the lower ring having three segments that may be arranged together below the aortic annulus in a non-circular ring shape, each segment having at least one connection member secure thereto and projecting upward through the aortic annulus to the atrial side thereof;

advancing a heart valve and securing ring toward the aortic annulus, the securing ring extending outward from an inflow end of the heart valve and having apertures therethrough;

inserting each of the connection members extending upward from the lower ring through an aperture in the securing ring around the heart valve;

advancing the heart valve and securing ring into contact with the aortic annulus;

applying tension to the connection members so as to clamp the aortic annulus between the lower ring and the securing ring;

securing the position of each connection member within its respective aperture; and

trimming each connection member closely above its respective aperture.

17. The method of claim 16, wherein the three segments of the lower ring are joined by flexible links.

18. The method of claim 16, wherein the securing ring has an undulating contour with axial peaks intermediate axial valleys, and a non-circular periphery with outwardly projecting lobes coinciding with the axial valleys and radially inward relief areas coinciding with the axial peaks.

19. The method of claim 18, wherein the three segments of the segmented lower ring coincide with the outwardly projecting lobes of the securing ring, and have gaps therebetween coinciding with the radially inward relief areas of the securing ring.

20. The method 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, and wherein the step of securing the position of each connection member within its respective aperture occurs by applying tension to the connection member.