METHOD FOR DIRECT IMPLANTATION OF A HEART VALVE PROSTHESIS

• US 20110238166A1
• Filed: 06/10/2011
• Published: 09/29/2011
• Est. Priority Date: 09/12/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: GABBAY, SHLOMO
• Granted Patent: US 9,414,912 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A method for implanting a heart valve into a patient'"'"'s heart can include inserting the heart valve prosthesis into a barrel of an implanter apparatus, such that the heart valve prosthesis has a reduced cross-sectional dimension relative to a fully expanded cross-sectional dimension of the heart valve prosthesis. An opening is created in muscle tissue of the patient'"'"'s heart to provide a substantially direct path that extends from the opening to a desired implantation site in the heart. A length of the barrel is inserted through the opening in the tissue such that an end of the barrel and the opening are along the direct path to the implantation site. The heart valve prosthesis is advanced through the barrel to the implantation site. The heart valve prosthesis is positioned at the desired implantation site. The heart valve prosthesis can be expanded at the desired implantation site from the reduced cross-sectional dimension toward the expanded cross-sectional dimension, such that an exterior portion of the heart valve prosthesis engages adjacent tissue to mitigate movement of the heart valve prosthesis relative to the adjacent tissue.

Claims

1. A method for implanting a heart valve prosthesis into a patient'"'"'s heart, the method comprising:

inserting the heart valve prosthesis into a barrel of an implanter apparatus, such that the heart valve prosthesis has a reduced cross-sectional dimension relative to a fully expanded cross-sectional dimension of the heart valve prosthesis;

creating an opening in muscle tissue of the patient'"'"'s heart to provide a substantially direct path that extends from the opening to a desired implantation site in the heart;

introducing a length of the barrel through the opening in the tissue such that an end of the barrel and the opening are along the direct path to the implantation site;

advancing the heart valve prosthesis through the barrel to the implantation site;

positioning the heart valve prosthesis at the desired implantation site;

expanding the heart valve prosthesis at the desired implantation site from the reduced cross-sectional dimension toward the expanded cross-sectional dimension, such that an exterior portion of the heart valve prosthesis engages adjacent tissue to mitigate movement of the heart valve prosthesis relative to the adjacent tissue.

2. The method of claim 1 wherein the opening is in a ventricle of the heart.

3. The method of claim 2 wherein the opening is made with a purse string suture.

4. The method of claim 2 wherein the implantation site is at an aortic valve.

5. The method of claim 2 wherein the implantation site is at a mitral valve.

6. The method of claim 2 wherein the implantation site is at a pulmonic valve.

7. The method of claim 2 wherein the implantation site is at a tricuspid valve.

8. The method of claim 2 wherein the positioning is performed using x-ray imaging.

9. The method of claim 2, 3, 4, 5, 6, 7 or 8 wherein the heart valve prosthesis is expanded using a balloon catheter.

10. The method of claim 2, 3, 4, 5, 6, 7 or 8 wherein the heart valve prosthesis is self expandable.

11. A method for implanting a heart valve prosthesis into a patient'"'"'s heart, the method comprising:

inserting the heart valve prosthesis into a catheter, such that the prosthesis has a reduced cross-sectional dimension corresponding to a dimension of the catheter, the heart valve prosthesis being configured to expand from the reduced cross-sectional dimension to an expanded cross-sectional dimension, which is greater than the reduced cross-sectional dimension;

creating an opening in tissue to provide a substantially linear path extending along a substantially straight line from the opening to a desired implantation position for replacing a heart valve in the patient'"'"'s heart;

passing an open end of the catheter through the opening;

positioning the open end of the catheter adjacent the desired implantation position in the patient'"'"'s heart such that the open end of the catheter and the opening are along the substantially straight line;

discharging the heart valve prosthesis from the catheter at the desired implantation position, whereupon the heart valve prosthesis expands from the reduced cross-sectional dimension to an expanded cross-sectional dimension, such that an exterior portion of the heart valve prosthesis engages adjacent tissue to mitigate movement of the heart valve prosthesis relative to the adjacent tissue.

12. The method of claim 11 wherein the opening is in a ventricle of the heart.

13. The method of claim 12 wherein the opening is made with a purse string suture.

14. The method of claim 12 wherein the implantation site is at an aortic valve.

15. The method of claim 12 wherein the implantation site is at a mitral valve.

16. The method of claim 12 wherein the implantation site is at a pulmonic valve.

17. The method of claim 12 wherein the implantation site is at a tricuspid valve.

18. The method of claim 12 wherein the positioning is performed using x-ray imaging.

19. The method of claim 12, 13, 14, 15, 16, 17 or 18 wherein the heart valve is self expandable.

20. The method of claim 12, 13, 14, 15, 16, 17 or 18 wherein the heart valve is expanded with a balloon catheter.