METHOD FOR IMPLANTATION OF A HEART VALVE PROSTHESIS

• US 20160324634A1
• Filed: 07/19/2016
• Published: 11/10/2016
• Est. Priority Date: 09/12/2000
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Gabbay, Shlomo
• Application Number:
  US15/214,261
• Publication Number:
  US 20160324634A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 securing the heart valve prosthesis to a distal portion of an implanter apparatus. An opening is created in muscle tissue of the patient'"'"'s heart, through which a length of the barrel is inserted such that an end of the barrel is advanced toward 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 to anchor the prosthesis into adjacent tissue.

Claims

1. A method for implanting a prosthetic heart valve into a patient, the method comprising:

inserting an expandable prosthetic heart valve into a barrel of an implanter, wherein the expandable prosthetic heart valve is in a reduced cross-sectional configuration within the barrel of the implanter, wherein the barrel has an outer diameter;

creating a small opening through a muscular wall of a heart of the patient, wherein the opening is sized to tightly receive an outer diameter of the barrel of the implanter;

inserting a length of the barrel of the implanter through the opening such that an end of the barrel is positioned within a heart chamber and tissue around the small opening tightly engages the outer diameter of the barrel;

advancing the expandable prosthetic heart valve through the barrel and into the heart chamber;

positioning the expandable prosthetic heart valve at the desired implantation site;

expanding the expandable prosthetic heart valve at the desired implantation site from a reduced cross-sectional dimension to an expanded cross-sectional dimension, such that an exterior portion of the prosthetic heart valve engages adjacent tissue to secure the prosthetic heart valve relative to the adjacent tissue.

2. The method of claim 1, wherein positioning the expandable prosthetic heart valve at the desired implantation site comprises discharging at least a portion of the expandable prosthetic heart valve from the barrel of the implanter.

3. The method of claim 1, wherein the heart chamber is a ventricle of the heart.

4. The method of claim 3, wherein the opening is in an exterior ventricular wall of the heart.

5. The method of claim 4, wherein the implantation site is adjacent an upper region of the ventricle of the heart.

6. The method of claim 5, wherein the implantation site is at a pulmonary position.

7. The method of claim 1, wherein the expandable prosthetic heart valve is self-expanding.

8. The method of claim 1, wherein expanding the expandable prosthetic heart valve at the desired implantation site further comprises urging the expandable prosthetic heart valve radially outward using a balloon catheter.

9. A method for implanting a prosthetic heart valve into a patient, the method comprising:

creating a small opening in at least one of heart muscle, aortic wall, or pulmonary artery wall of the patient, wherein the small opening comprises an incision or puncture of relatively small size;

advancing a distal end of a barrel of an implanter through the small opening and into a heart chamber, wherein the relatively small size of the small opening results in tissue around the small opening being tight around the barrel of the implanter to thereby mitigate blood loss;

distally advancing a radially-expandable prosthetic heart valve with respect to the barrel of the implanter;

releasing the radially-expandable prosthetic heart valve from the implanter at a desired deployment position; and

radially expanding the radially-expandable prosthetic heart valve into contact with tissue at the desired deployment position.

10. The method of claim 9, wherein the radially-expandable prosthetic heart valve comprises a self-expanding support stent comprising shape memory material, and wherein distally advancing the radially-expandable prosthetic heart valve with respect to the barrel results in radially expanding the radially-expandable prosthetic heart valve.

11. The method of claim 9, wherein the heart chamber comprises a ventricle, and the small opening is formed in an exterior wall of the ventricle.

12. The method of claim 11, wherein the desired deployment position is a pulmonary position.

13. The method of claim 9, wherein creating the small opening comprises applying a purse string suture to tissue around the incision or puncture.

14. The method of claim 9, wherein radially expanding the radially-expandable prosthetic heart valve comprises applying radially expansive force to the radially-expandable prosthetic heart valve via a balloon catheter.

15. The method of claim 9, wherein the method is performed in the absence of cardiopulmonary bypass on the patient.

16. A method for implanting a prosthetic heart valve into a patient, the method comprising:

securing the prosthetic heart valve in a radially compressed configuration at a distal end of a catheter, wherein the prosthetic heart valve comprises a support stent and valve leaflets, the prosthetic heart valve comprising the radially compressed configuration and a radially expanded configuration, wherein the prosthetic heart valve is configured to radially expand from the radially compressed configuration to the radially expanded configuration;

creating an opening in heart muscle tissue to provide a path into a heart chamber, wherein the opening is configured to tightly receive a distal portion of the catheter therein;

passing the distal end of the catheter through the opening;

positioning the distal end of the catheter adjacent a desired implantation site;

releasing the prosthetic heart valve from the distal end of the catheter at the desired implantation site; and

expanding the prosthetic heart valve from the radially compressed dimension to the radially expanded configuration, whereby the prosthetic heart valve expands into engagement with tissue at the desired implantation site to thereby anchor the prosthetic heart valve at the desired implantation site.

17. The method of claim 16, wherein the heart chamber is a ventricle of the heart, and the opening is in an exterior wall of the ventricle.

18. The method of claim 17, wherein the ventricle is a right ventricle.

19. The method of claim 18, wherein the implantation site is at a pulmonic position of the heart.

20. The method of claim 16, wherein the prosthetic heart valve comprises a self-expanding stent, wherein the prosthetic heart valve is held in radial compression by the catheter and wherein expanding the prosthetic heart valve is effectuated by releasing the prosthetic heart valve from the distal end of the catheter.