Efficient implantation of heart valve prostheses

• US 7,563,280 B2
• Filed: 07/07/2003
• Issued: 07/21/2009
• Est. Priority Date: 04/28/1999
• Status: Expired due to Fees

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Langanki, Danney J., Anderson, Kimberly A.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US10/614,741
• Publication Number:
  US 20040078074A1
• Time in Patent Office: 2,206 Days
• Field of Search: 623 21- 219, 623/904, 623/1.26, 623/910, 623/922, 606/142, 606/143, 606/151, 606213-221
• US Class Current: 623/2.13
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• CPC Class Codes: A61B 2017/1157 applying the staples radially
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Tools can be used to assist with the implantation of heart valve prostheses, especially stentless aortic heart valve prostheses. In some embodiments, a heart valve prosthesis includes a plurality of flexible leaflets, a commissure support and a plurality of fasteners inserted into the inner surface of the commissure support and protruding from the outer surface of the commissure support. The fasteners comprise an elongated portion and a tip at an end of the elongated portion. In other embodiments, a heart valve prosthesis includes a plurality of flexible leaflets and a reinforcement secured to an inner surface of a valve commissure support. The reinforcement has an aperture. The heart valve prosthesis and fastener components can be placed into kits. The fasteners can be used to perform improved implantation procedures.

Claims

1. A method for attaching a heart valve prosthesis in a patient, the method comprising:

providing a fastener having a head and a sharp tip, a prosthesis, and a separate reinforcement, the reinforcement comprising a first leg and a second leg connected together with a top portion;

positioning the prosthesis comprising leaflets with a plurality of commissure supports separated by a plurality of scallops in a selected position proximate an aortic wall, a root, or a pulmonary artery wall;

positioning the reinforcement along an inner surface of at least one of the commissure supports, wherein the reinforcement has at least one aperture, wherein an end of the first leg extends to a first scallop and an end of the second leg extends to a second scallop, wherein the reinforcement is configured to be positioned proximate a curved outflow edge of the at least one commissure supports; and

inserting the tip of the fastener through the at least one aperture in the reinforcement, the prosthesis and the aortic wall or root or the pulmonary artery wall to attach the heart valve prosthesis in a patient.

2. The method of claim 1 wherein the heart valve prosthesis comprises a stentless porcine valve.

3. The method of claim 1 wherein each of the commissure supports of the prosthesis comprises at least one reinforcement.

4. The method of claim 1 wherein a plurality of fasteners are inserted to secure the prosthesis to the aortic wall or root or the pulmonary artery wall.

5. The method of claim 4 wherein the fasteners are inserted along a curvilinear path.

6. The method of claim 1 wherein the fastener further comprises an elongated portion, the tip at an end of the extended portion and the head on the end opposite the tip, the tip passing through the commissure support and through the aortic wall or root or the pulmonary artery wall to secure the prosthesis to the aortic wall or root or the pulmonary artery wall.

7. The method of claim 6 further comprising providing the head of the fastener with a shape such that the head is larger than a diameter of the elongated portion of the fastener.

8. The method of claim 6 wherein the elongated portion of the fastener extends through the prosthesis and the aortic wall or root or the pulmonary artery wall to secure the prosthesis to the aortic wall or root or the pulmonary artery wall.

9. The method of claim 1 further comprising providing a barb on the tip of the fastener to maintain the fastener in place after insertion.

10. The method of claim 1 wherein the heart valve prosthesis comprises a tissue valve.

11. The method of claim 1 wherein the heart valve prosthesis comprises a polymer valve.

12. The method of claim 1 wherein the prosthesis further comprises a second reinforcement attached to a scallop formed between the commissure supports of the prosthesis, the reinforcement having apertures for insertion of the fastener.

13. The method of claim 1 wherein the tip of the fastener is tapered.

14. A method for attaching a heart valve prosthesis in a patient, the method comprising:

providing a separate reinforcement having at least one aperture, the reinforcement comprising a first leg and a second leg connected together with a top portion;

providing a fastener having a head and a sharp tip;

inserting the fastener through the at least one aperture in the reinforcement;

positioning a prosthesis comprising leaflets with a plurality of commissure supports separated by a plurality of scallops in a selected position proximate an aortic wall, a root, or a pulmonary artery wall;

positioning the reinforcement along an inner surface of at least one of the commissure supports, wherein an end of the first leg extends to a first scallop and an end of the second leg extends to a second scallop, wherein the reinforcement is configured to be secured proximate a curved outflow edge of the commissure supports; and

inserting the tip of the fastener through the prosthesis and through an aortic wall or root or a pulmonary artery wall to attach the heart valve prosthesis to a patient.

15. The method of claim 14 wherein each of the commissure supports of the prosthesis comprises at least one reinforcement.

16. The method of claim 14 wherein a plurality of fasteners are inserted to secure the prosthesis to the aortic wall or root or the pulmonary artery wall.

17. The method of claim 14 wherein the fastener further comprises an elongated portion, the tip at an end of the extended portion and the head on the end opposite the tip, the tip passing through the commissure support and through the aortic wall or root or the pulmonary artery wall to secure the prosthesis to the aortic wall or root or the pulmonary artery wall.

18. A method for attaching a heart valve prosthesis in a patient, the method comprising:

providing a fastener having a head and a sharp tip, a prosthesis, and a separate reinforcement, the reinforcement comprising a first leg and a second leg connected together with a top portion;

positioning the prosthesis comprising leaflets with valve commissure supports separated by a plurality of scallops in a selected position proximate an aortic wall, a root, or a pulmonary artery wall;

positioning the reinforcement along an outer surface of the prosthesis, the reinforcement having at least one aperture, wherein an end of the first leg extends to a first scallop and an end of the second leg extends to a second scallop, wherein the reinforcement is configured to be proximate a curved outflow edge of the prosthesis;

inserting the tip of the fastener through the prosthesis, the at least one aperture in the reinforcement, and through an aortic wall or root or a pulmonary artery wall to attach the heart valve prosthesis to the patient.

19. The method of claim 18 wherein the reinforcement is positioned along at least one of the valve commissure supports along the outer surface of the prosthesis.

20. The method of claim 18 wherein the reinforcement is positioned on the outside surface of the aorta.