Method and apparatus for performing catheter-based annuloplasty using local plications

• US 8,460,371 B2
• Filed: 10/21/2003
• Issued: 06/11/2013
• Est. Priority Date: 10/21/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Mitralign, Inc. (Edwards Lifesciences Corporation)
• Inventors: Hlavka, Edwin J., Spence, Paul A.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US10/689,872
• Publication Number:
  US 20040172046A1
• Time in Patent Office: 3,521 Days
• Field of Search: 623/2.11, 623 236- 241, 606/139, 606142-143, 606/151, 128/898
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0649 Coils or spirals

Abstract

The present invention relates to minimally invasive methods and apparatus for performing annuloplasty. According to one aspect of the present invention, a method for performing annuloplasty includes creating a first plication in the tissue near a mitral valve of a heart, using at least a first plication element, and creating a second plication in the tissue near the mitral valve such that the second plication is substantially coupled to the first plication. In another aspect, an apparatus for performing annuloplasty includes a distal catheter portion having a sidewall defining a lumen, anchor delivery structure disposed in the lumen, and al least one anchor supported on the anchor delivery structure. The anchor delivery structure is movable from a first position wherein the anchor is disposed within the lumen, to a second position wherein the anchor is moved through an opening.

Claims

1. An anchor delivery catheter for performing catheter-based annuloplasty by delivering anchors to heart tissue, the anchor delivery catheter comprising:

a distal catheter portion adapted to be received into a chamber of a heart, said distal catheter portion including a distal tip and at least one sidewall defining a lumen along the catheter;

an opening in said sidewall of said distal catheter portion and spaced proximally from said distal tip, said opening communicating with said lumen to facilitate the delivery of anchors through said lumen and said opening to heart tissue;

anchor delivery structure disposed in said lumen;

a plurality of anchors releasably supported on said anchor delivery structure and adapted to anchor to the heart tissue, wherein each anchor includes a rigid member at a distal end thereof and the rigid member is at least partially disposed along said anchor delivery structure, wherein the anchor delivery structure extends through each of the rigid members of the plurality of anchors which are located in series along the anchor delivery structure; and

at least one elongate tensile member having a free proximal end, the elongate tensile member having a distal end operatively coupled to the rigid member of the at least one anchor, the at least one elongate tensile member extending proximally from the rigid member;

said anchor delivery structure being movable relative to the distal catheter portion in the chamber of the heart from a first position wherein said anchor is disposed within said lumen, to a second position wherein said anchor is moved through said opening to engage the heart tissue, and to a third position wherein said anchor is separated from said anchor delivery structure and remains engaged with the heart tissue.

2. The anchor delivery catheter of claim 1, wherein said distal catheter portion is convertible between a first condition wherein said distal catheter portion has a shape that does not conform to the contour of the gutter of the mitral valve, and a second condition wherein the shape of said distal catheter portion conforms to the contour of the gutter of the mitral valve.

3. The anchor delivery catheter of claim 1, further comprising at least a second anchor disposed within said lumen and supported on said anchor delivery structure, the second anchor including a rigid member at a distal end thereof and a second elongate tensile member extending proximally therefrom.

4. The anchor delivery catheter of claim 3, wherein said anchor delivery structure is further moveable to move said second anchor through said opening to engage the heart tissue.

5. The anchor delivery catheter of claim 3, further comprising a locking element coupled to said tensile members for movement therealong relative to said anchors, wherein said locking element is adapted to remain coupled to said tensile members and separated from the anchor delivery catheter.

6. An anchor delivery catheter for performing catheter-based annuloplasty by delivering anchors to heart tissue, the anchor delivery catheter comprising:

a distal catheter portion adapted to be received into a chamber of a heart, said distal catheter portion including a distal tip and at least one sidewall defining a lumen along the catheter;

an opening in said sidewall of said distal catheter portion and spaced proximally from said distal tip, said opening communicating with said lumen to facilitate the delivery of anchors through said lumen and said opening to heart tissue;

anchor delivery structure disposed in said lumen;

at least first and second anchors releasably and serially supported on said anchor delivery structure and adapted to anchor to the heart tissue, wherein each anchor includes a rigid member at a distal end thereof and each rigid member is at least partially disposed along said anchor delivery structure, wherein the anchor delivery structure extends through each of the rigid members of the first and second anchors, the rigid members being supported in series along the anchor delivery structure; and

at least first and second elongate tensile members each having a free proximal end, and each elongate tensile member having a distal end operatively coupled to a respective rigid member of the at first and second anchors, the at least first and second elongate tensile members extending independently and alongside one another and proximally the respective rigid members;

said anchor delivery structure being movable relative to the distal catheter portion in the chamber of the heart from a first position wherein said first anchor is disposed within said lumen, to a second position wherein said first anchor is moved through said opening to engage the heart tissue, and to a third position wherein said first anchor is separated from said anchor delivery structure and remains engaged with the heart tissue while said elongate tensile members extend alongside one another proximally to a location that is accessible exteriorly of a patient.

7. The anchor delivery catheter of claim 6, wherein said distal catheter portion is convertible between a first condition wherein said distal catheter portion has a shape that does not conform to the contour of the gutter of the mitral valve, and a second condition wherein the shape of said distal catheter portion conforms to the contour of the gutter of the mitral valve.

8. The anchor delivery catheter of claim 6, wherein said anchor delivery structure is further moveable to move said second anchor through said opening to engage the heart tissue.

9. The anchor delivery catheter of claim 8, further comprising a locking element coupled to said tensile members for movement therealong relative to said anchors, wherein said locking element is adapted to remain coupled to said tensile members and separated from the anchor delivery catheter.