Method and apparatus for catheter-based annuloplasty using local plications

• US 7,037,334 B1
• Filed: 07/18/2003
• Issued: 05/02/2006
• Est. Priority Date: 04/24/2001
• Status: Expired due to Fees

• Current Assignee: Mitralign, Inc. (Edwards Lifesciences Corporation)
• Original Assignee: Mitralign, Inc. (Edwards Lifesciences Corporation)
• Inventors: Hlavka, Edwin J., Spence, Paul A., Podmore, Jonathan L.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, William H
• Application Number:
  US10/623,182
• Time in Patent Office: 1,019 Days
• Field of Search: 623/2.36, 623/2.37, 606/139, 606142-144, 606/151, 606/153, 606155-159
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus

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 annuloplasty includes accessing a left ventricle of a heart to provide a discrete plication element to the left ventricle, and engaging the plication element to tissue near a mitral valve of the heart. Engaging the plication element includes causing the plication element to gather a portion of the tissue to create a plication. In one embodiment, accessing the left ventricle of the heart to provide the plication element includes accessing the left ventricle of the heart using a catheter arrangement.

Claims

1. A system for use in an annuloplasty procedure, the system comprising:

a catheter assembly configured for insertion through an aorta of the heart into a left ventricle of the heart to reach a region of the left ventricle substantially below the mitral valve; and

a suture structure comprising a first bar member, a second bar member, a thread, and a locking element, the first bar member and the second bar member being coupled to the thread, the locking element being arranged to move over the thread, the catheter assembly being configured to cause the first bar member and the second bar member to penetrate tissue near the mitral valve, the catheter assembly further being configured to move the locking element over the thread into contact with the tissue on a ventricular side of the mitral valve, wherein a plication is created in the tissue substantially between the first bar member, the second bar member, and the locking element.

2. A system for use in an annuloplasty procedure, the system comprising:

a catheter assembly configured for introduction through the vascular system and into the heart of a patient to a location near the mitral valve; and

a plication assembly including a first plicating element, a second plicating element, a first thread portion, a second thread portion, and a locking element, the first plicating element and the second plicating element being respectively coupled to the first and second thread portions, the locking element being arranged to move over the first and second thread portions, the catheter assembly being configured to cause the first plicating element and the second plicating element to penetrate tissue near the mitral valve, the catheter assembly further being configured to move the locking element over the first and second thread portions toward the first and second plicating elements to create a plication in the tissue substantially between the first plicating element, the second plicating element, and the locking element.

3. The system of claim 2, wherein said locking element further comprises a one-way locking element.

4. The system of claim 2, further comprising:

a first pledget coupled for movement along the first thread portion and configured to be positioned on an opposite side of the tissue from the first plicating element, and

a second pledget coupled for movement along the second thread portion and configured to be positioned on an opposite side of the tissue from the second plicating element,

whereby the tissue is held between the first plicating element and the first pledget and between the second plicating element and the second pledget.

5. The system of claim 4, wherein the first and second pledgets are formed from a material that supports the growth of scar tissue therethrough.

6. The system of claim 2, wherein the first and second thread portions are connected together on a side of the locking element opposite to the first and second plicating elements.

7. The system of claim 2, wherein the first and second thread portions each have free ends on a side of the locking element opposite to the first and second plicating elements.

8. A system for use in an annuloplasty procedure, the system comprising:

a catheter assembly configured for introduction through the vascular system and into the heart of a patient to a location near the mitral valve; and

a plication assembly comprising a first plicating element, a second plicating element, a first thread portion coupled to the first plicating element, a second thread portion coupled to the second plicating element, and a locking element coupled for movement along the first and second thread portions at a location generally between the first and second plicating elements, the catheter assembly being configured to cause the first and second plicating elements to penetrate tissue near the mitral valve, the catheter assembly further being configured to move the locking element over the first and second thread portions toward the first and second plicating elements to create a plication in the tissue substantially between the first plicating element, the second plicating element, and the locking element.

9. The system of claim 8, wherein said locking element further comprises a one-way locking element.

10. The system of claim 8, further comprising:

a first pledget coupled for movement along the first thread portion and configured to be positioned on an opposite side of the tissue from the first plicating element, and

a second pledget coupled for movement along the second thread portion and configured to be positioned on an opposite side of the tissue from the second plicating element,

whereby the tissue is held between the first plicating element and the first pledget and between the second plicating element and the second pledget.

11. The system of claim 10, wherein the first and second pledgets are formed from a material that supports the growth of scar tissue therethrough.

12. The system of claim 8, wherein the first and second thread portions are connected together on a side of the locking element opposite to the first and second plicating elements.

13. The system of claim 8, wherein the first and second thread portions each have free ends on a side of the locking element opposite to the first and second plicating elements.

14. A system for use in an annuloplasty procedure, the system comprising:

a catheter assembly configured for introduction through the vascular system and into the heart of a patient to a location near the mitral valve; and

a plication assembly including a first plicating element, a second plicating element, a first thread portion, a second thread portion, and a locking element, the first plicating element and the second plicating element being respectively coupled to the first and second thread portions, the locking element being arranged to move over the first and second thread portions, the catheter assembly being configured to move the locking element over the first and second thread portions toward the first and second plicating elements after the first and second plicating elements have been penetrated into tissue near the mitral valve with movement of the locking element thereby creating a plication in the tissue substantially between the first plicating element, the second plicating element, and the locking element.