Method of implantation of a heart valve prosthesis through a tubular catheter

• US 7,803,185 B2
• Filed: 10/08/2002
• Issued: 09/28/2010
• Est. Priority Date: 09/12/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): Pellegrino; Brian E.
• Application Number:
  US10/266,380
• Publication Number:
  US 20030040792A1
• Time in Patent Office: 2,912 Days
• Field of Search: 623/902, 623/903, 623/904, 623/2.11, 623/1.2, 623/1.26, 623/1.24, 606/108
• 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 of implanting a heart valve prosthesis is disclosed. A valve is mounted within a support apparatus that is deformable between an expanded and a reduced cross-sectional condition. The prosthesis can be implanted into a patient'"'"'s heart, such as during a direct vision procedure through a generally tubular implantation apparatus that maintains the prosthesis in its reduced cross-sectional condition until discharged from the tubular apparatus at a desired implantation site.

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, such that the prosthesis has a reduced cross-sectional dimension relative to a fully expanded cross-sectional dimension of the prosthesis;

opening a patient'"'"'s chest;

creating an opening in tissue located within the open patient'"'"'s chest to provide a substantially direct path that extends from the opening to a desired implantation site in the patient'"'"'s heart, the opening in the tissue being created in the patient'"'"'s pulmonary artery, the patient'"'"'s aorta or heart muscle of the patient so that the opening opposes the desired implantation site;

passing a length of the barrel through the opening in the tissue to position an end of the barrel of the implanter adjacent the desired implantation site in the patient'"'"'s heart such that the end of the barrel and the opening are along the direct path;

discharging the heart valve prosthesis from the barrel of the implanter adjacent the desired implantation site; and

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 prosthesis relative to the adjacent tissue.

2. The method of claim 1, the expanding occurring automatically in response to removal of the heart valve prosthesis from the barrel.

3. The method of claim 1 occurring in the absence of caridiopulmonary bypass.

4. The method of claim 1, further comprising urging a portion of the tissue that surrounds the opening in the tissue into engagement with part of the implanter to mitigate blood loss through the opening.

5. The method of claim 4, the urging further comprising applying a purse string around the opening and tightening the purse string around an adjacent part of the implanter at the opening to mitigate the blood loss through the opening.

6. The method of claim 1, the heart valve prosthesis further comprising a generally cylindrical support extending between opposed ends thereof, a plurality of elongated support features extending generally axially between the opposed ends of the support, the support features being interconnected at ends of the support, and a tissue valve mounted within the support so as to radially expand commensurately with the support.

7. The method of claim 6, the support further comprising a generally circular array of biasing elements at each end of the support that interconnect adjacent support features and urge the interconnected adjacent support features apart from each other.

8. The method of claim 6, the support further comprising a set of projections at each of the opposed ends of the support and biased to extend axially and radially outwardly from the support, the projections engaging adjacent tissue after the heart valve prosthesis expands to the expanded cross-sectional dimension to help anchor the prosthesis relative to the patient'"'"'s heart.

9. The method of claim 1, further comprising attaching a length of at least one suture to the prosthesis and, after discharging the prosthesis, using the at least one suture to adjust the relative position of the prosthesis.

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

inserting the heart valve prosthesis into a generally cylindrical and elongated enclosure, such that the prosthesis has a reduced cross-sectional dimension corresponding to a dimension of the cylindrical enclosure, the prosthesis being configured to self-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 line of sight from the opening to a desired implantation position for replacing a heart valve in the patient'"'"'s heart;

passing an open end of the cylindrical enclosure through the opening;

positioning the open end of the cylindrical enclosure adjacent the desired implantation position in the patient'"'"'s heart such that the open end of the cylindrical enclosure and the opening;

discharging the heart valve prosthesis from the cylindrical enclosure 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 prosthesis relative to the adjacent tissue.

11. The method of claim 10, the cylindrical enclosure being substantially rigid and substantially linear, such that when the open end of the cylindrical enclosure is positioned adjacent the desired implantation position, the open end of the cylindrical enclosure and the opening are along the linear path.

12. The method of claim 11, further comprising urging an adjacent part of the tissue that surrounds the opening into engagement with part of the cylindrical enclosure to mitigate blood loss through the opening.

13. The method of claim 12, the urging further comprising applying a purse string around the adjacent part of the blood vessel that surrounds the opening and tightening the purse string around part of the cylindrical enclosure to mitigate the blood loss through the opening.

14. The method of claim 10, the tissue comprising heart muscle of the patient.

15. The method of claim 10, further comprising attaching a length of at least one suture to the prosthesis and, after discharging the prosthesis, using the at least one suture, part of which extends from the heart valve prosthesis through the opening, to adjust the relative position of the prosthesis.

16. The method of claim 10, wherein the heart valve prosthesis further comprises:

a generally cylindrical support extending between opposed ends thereof, a plurality of support features extend generally axially between the opposed ends of the support and are interconnected so as to bias the support radially outwardly; and

a natural tissue heart valve mounted within the support to define a supported valve, the supported valve being deformable between a reduced cross sectional dimension and the expanded cross sectional dimension.

17. The method of claim 10, wherein the opening is created in one of the patient'"'"'s pulmonary artery or the patient'"'"'s aorta.

18. A method for implanting a heart valve prosthesis, comprising:

creating an opening in a tissue that provides a linear path extending from the opening to a desired implantation position in the patient'"'"'s heart, the opening being created in one of the patient'"'"'s pulmonary artery, the patient'"'"'s aorta or heart muscle of the patient to provide the linear path;

passing a length of a cylindrical barrel through the opening to position an end of the barrel at the desired position in the patient'"'"'s heart, an expandable heart valve prosthesis being located within the barrel; and

discharging the heart valve prosthesis from the barrel to the desired implantation position for replacing a heart valve in the patient'"'"'s heart so that the discharged heart valve prosthesis expands to an expanded cross sectional dimension that contacts adjacent tissue in the patient'"'"'s heart to mitigate movement of the heart valve prosthesis relative to the patient'"'"'s heart.

19. The method of claim 18, further comprising, after discharging the heart valve prosthesis, using at least one suture, which extends from the prosthesis through the opening, to adjust the relative position of the prosthesis.

20. The method of claim 18, wherein the heart valve prosthesis:

a generally cylindrical support extending between opposed ends thereof, a plurality of support features extend generally axially between the opposed ends of the support and are interconnected so as to bias the support radially outwardly; and

a natural tissue heart valve mounted within the support to define a supported valve, the supported valve being deformable between the reduced cross sectional dimension and the expanded cross sectional dimension.

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

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

creating an opening through the patient'"'"'s heart muscle such that a desired implantation site in the patient'"'"'s heart is in a line of sight with the opening;

inserting a length of the barrel through the opening in the heart muscle to position an end of the barrel to a location that is adjacent the desired implantation site in the patient'"'"'s heart, such that the end of the barrel is in a line of sight with the opening;

discharging the heart valve prosthesis from the barrel of the implanter at the location adjacent the desired implantation site; and

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 prosthesis relative to the adjacent tissue.

22. The method of claim 21, wherein the desired implantation site is the pulmonic position.

23. The method of claim 21, wherein the desired implantation site is the aortic position.

24. The method of claim 21, wherein the expansion of the heart valve prosthesis at the desired implantation site occurs automatically in response to be discharged from the barrel.

25. The method of claim 21, wherein the barrel further comprises a substantially rigid elongated cylinder that extends axially from a first end and terminates in the end of the barrel, the substantially rigid elongated cylinder having an inner diameter in a range from about 5 mm to about 15 mm.