Method and apparatus for catheter-based annuloplasty

• US 6,619,291 B2
• Filed: 04/24/2001
• Issued: 09/16/2003
• Est. Priority Date: 04/24/2001
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwin J. Hlavka, Paul A. Spence
• Inventors: Hlavka, Edwin J., Spence, Paul A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, William H.
• Application Number:
  US09/841,968
• Publication Number:
  US 20020156526A1
• Time in Patent Office: 875 Days
• Field of Search: 623/2-8-, 623/2.11, 623/904, 128/898, 606/151
• US Class Current: 128/898
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: Y10S 623/904 Heart

Abstract

The present invention relates to a minimally invasive method of performing annuloplasty. According to one aspect of the present invention, a method for performing a procedure on a mitral valve of a heart includes inserting an implant into a left ventricle and orienting the implant in the left ventricle substantially below the mitral valve. The implant and tissue around the mitral valve are connected and tension is provided to the implant, in one embodiment, in order to substantially reduce an arc length associated with the mitral valve. In another embodiment, the implant is inserted into the left ventricle through the aorta and the aortic valve.

Claims

1. A method for performing a procedure on a mitral valve of a heart, the method comprising:

inserting at least one implant into a left ventricle of the heart wherein inserting the implant into the left ventricle includes introducing the implant into an aorta and passing the implant through an aortic valve interposed between the aorta and the left ventricle;

introducing a guide element into the left ventricle, the guide element being configured to be positioned in the left ventricle between a plane of the mitral valve and a plane associated with papillary muscles of the heart, wherein inserting the implant into the left ventricle includes positioning the implant such that the implant uses the guide element as a track and wherein introducing the guide element into the left ventricle further includes (a) introducing a first catheter assembly into the aorta, the first catheter assembly including an angled catheter, and a gutter catheter, wherein the angled catheter substantially carries the gutter catheter, the angled catheter being arranged to facilitate positioning of the gutter catheter,(b) positioning the gutter catheter beneath the mitral valve between the plane of the mitral valve and the plane associated with the papillary muscles, wherein positioning the gutter catheter includes positioning the gutter catheter along a wall of the left ventricle, and (c) inserting the guide element into a lumen of the gutter catheter;

positioning the at least one implant with respect to the mitral valve, wherein positioning the implant includes orienting the implant in the left ventricle substantially below the mitral valve;

attaching the implant to tissue located near the mitral valve;

reducing an arc length of the implant, wherein reducing the arc length of the implant substantially reduces an arc length associated with the mitral valve; and

removing the guide element from the left ventricle after attaching the implant to the tissue.

2. A method as recited in claim 1 wherein introducing the guide element into the left ventricle further includes:

anchoring the guide element against the wall.

3. A method as recited in claim 1 wherein the tissue is fibrous tissue.

4. A method for performing a procedure on a mitral valve of a heart, the method comprising:

inserting at least one implant into a left ventricle of the heart wherein inserting the implant into the left ventricle includes introducing the implant into an aorta and passing the implant through an aortic valve interposed between the aorta and the left ventricle;

introducing a guide element into the left ventricle, the guide element being configured to be positioned in the left ventricle between a plane of the mitral valve and a plane associated with papillary muscles of the heart, wherein inserting the implant into the left ventricle includes positioning the implant such that the implant uses the guide element as a track;

positioning the at least one implant with respect to the mitral valve, wherein positioning the implant includes orienting the implant in the left ventricle substantially below the mitral valve;

attaching the implant to tissue located near the mitral valve, wherein attaching the implant to the tissue includes (a) introducing a catheter into the left ventricle using the guide element as a track, wherein the catheter includes at least one pointed wire, the pointed wire including a tip section, the pointed wire further being configured to carry a coupling element, the tip section being configured for insertion into the implant and the tissue, (b) pushing the tip section through the implant and the tissue, wherein pushing the tip section through the implant and the tissue positions at least a part of the coupling element on an atrial side of the tissue, and (c) retracting the tip section from the implant and the tissue, wherein retracting the tip section causes the coupling element to substantially couple the implant with the tissue;

reducing an arc length of the implant, wherein reducing the arc length of the implant substantially reduces an arc length associated with the mitral valve; and

removing the guide element from the left ventricle after attaching the implant to the tissue.

5. A method as recited in claim 4 wherein the coupling element is a T-bar.

6. A method as recited in claim 4 wherein the tissue is fibrous tissue.

7. A method for performing annuloplasty on a mitral valve of a heart, the method comprising:

inserting a first catheter assembly into a left ventricle through an aorta of the heart and an aortic valve of the heart;

positioning a guide element along a wall of the left ventricle beneath the mitral valve using the first catheter assembly, wherein the first catheter assembly includes a first catheter and a second catheter, the second catheter being located at least partially within the first catheter, the first catheter being arranged to facilitate the positioning of the second catheter along the wall of the left ventricle, and wherein positioning the guide element along the wall includes inserting the guide element through the second catheter, and anchoring the guide element against the wall;

positioning at least one implant in the left ventricle beneath the mitral valve using the guide element as a guide; and

connecting the at least one implant to tissue near the mitral valve.

8. A method as recited in claim 7 further including:

removing the first catheter and the second catheter from the left ventricle; and

inserting a third catheter into the left ventricle, the third catheter configured to carry the implant and to use the guide element as a guide.

9. A method for performing annuloplasty on a mitral valve of a heart, the method comprising:

inserting a first catheter assembly into a left ventricle through an aorta of the heart and an aortic valve of the heart;

positioning a guide element along a wall of the left ventricle beneath the mitral valve using the first catheter assembly;

positioning at least one implant in the left ventricle beneath the mitral valve using the guide element as a guide; and

connecting the at least one implant to tissue near the mitral valve, wherein connecting the implant to the tissue near the mitral valve includes inserting a second catheter into the left ventricle, the second catheter being configured to carry a first connection element and inserting the first connection element through the implant and the tissue such that the implant and the tissue are coupled by the first connection element, wherein the second catheter is further configured to carry a second connection element; and

inserting the second connection element through the implant and the tissue such that the implant and the tissue are coupled by the second connection element.

10. A method for performing annuloplasty on a mitral valve of a heart, the method comprising:

inserting a first catheter assembly into a left ventricle through an aorta of the heart and an aortic valve of the heart;

positioning a guide element along a wall of the left ventricle beneath the mitral valve using the first catheter assembly;

positioning at least one implant in the left ventricle beneath the mitral valve using the guide element as a guide, wherein positioning the implant in the left ventricle beneath the mitral valve using the guide element further includes inserting at least one balloon into the left ventricle and inflating the balloon, wherein inflating the balloon positions the implant generally against the mitral valve; and

connecting the at least one implant to tissue near the mitral valve, wherein connecting the implant to the tissue near the mitral valve includes inserting a second catheter into the left ventricle, the second catheter being configured to carry a first connection element and inserting the first connection element through the implant and the tissue such that the implant and the tissue are coupled by the first connection element.

11. A method for performing annuloplasty on a mitral valve of a heart, the method comprising:

inserting a first catheter assembly into a left ventricle through an aorta of the heart and an aortic valve of the heart;

positioning a guide element along a wall of the left ventricle beneath the mitral valve using the first catheter assembly;

positioning at least one implant in the left ventricle beneath the mitral valve using the guide element as a guide, wherein positioning the implant in the left ventricle beneath the mitral valve using the guide element further includes inserting at least one expandable element into the left ventricle and expanding the expandable element, wherein expanding the expandable element positions the implant generally against the mitral valve; and

connecting the at least one implant to tissue near the mitral valve, wherein connecting the implant to the tissue near the mitral valve includes inserting a second catheter into the left ventricle, the second catheter being configured to carry a first connection element and inserting the first connection element through the implant and the tissue such that the implant and the tissue are coupled by the first connection element.