CATHETER-BASED ANNULOPLASTY USING VENTRICULARLY POSITIONED CATHETER

• US 20100324669A1
• Filed: 08/02/2010
• Published: 12/23/2010
• Est. Priority Date: 04/24/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Mitralign, Inc. (Edwards Lifesciences Corporation)
• Inventors: Podmore, Jonathan L., Hlavka, Edwin J., Spence, Paul A.
• Granted Patent: US 8,202,315 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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 17/0487 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 17/064 Surgical staples, i.e. penetrating the tissue
• 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• 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 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61F 2/2442 : Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• 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 2/246 : Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor

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

1-36. -36. (canceled)

37. A method for performing an annuloplasty procedure, comprising the steps of:

introducing a catheter into a left ventricle of a heart;

positioning the catheter into a gutter region of the heart under a mitral valve and at an intersection of the mitral valve and a left ventricular wall until the catheter forms an arc shape along a contour of the left ventricular wall in the gutter region;

deploying a plurality of anchors from the catheter into tissue of the heart in the gutter region, wherein the anchors are connected by at least one suture;

plicating the heart tissue by applying tension to the at least one suture to cause the anchors to be drawn together, thereby creating plications in the heart tissue; and

applying a lock to the suture so as to maintain the anchors drawn together and to maintain the plications in the heart tissue.

38. The method of claim 37, further comprising the steps of:

introducing a guide wire into the gutter region of the heart,

wherein the step of positioning the catheter includes advancing the catheter over the guide wire.

39. The method of claim 37, further comprising the steps of:

introducing a guide wire into the gutter region of the heart at one side of the mitral valve;

advancing the guide wire along the gutter region until the guide wire forms an arc shape along the contour of the left ventricular wall in the gutter region; and

removably attaching a distal end of the guide wire to the heart tissue at a second side of the mitral valve,

wherein the step of positioning the catheter includes advancing the catheter over the guide wire.

40. The method of claim 39, wherein the distal end of the catheter is advanced to a position proximate a distal end of the guide wire, and wherein the step of deploying a plurality of anchors further comprises:

deploying a first anchor into the heart tissue on a same side of the mitral valve as the distal end of the guide wire;

withdrawing the catheter along the guide wire to a next position; and

deploying a successive anchor at the next position, wherein the steps of withdrawing and deploying are repeated for each successive anchor.

41. The method of claim 37, further comprising the steps of:

introducing a delivery tube through an aortic valve of the heart;

directing a distal end of the delivery tube toward a top portion of the left ventricular wall; and

deploying the catheter through the delivery tube.

42. A method for performing an annuloplasty procedure, comprising the steps of:

introducing a catheter into a left ventricle of heart;

positioning the catheter into a gutter region of the heart at an intersection of a posterior leaflet of a mitral valve and a left ventricular wall until the catheter forms an arc shape along a contour of the left ventricular wall in the gutter region;

deploying a plurality of anchors into tissue of the heart in the gutter region from the catheter, wherein the anchors are connected by at least one suture;

applying tension to the at least one suture so as to plicate the heart tissue sufficient to reposition the posterior leaflet so that the mitral valve closes with a beat of the heart to reduce regurgitation through the mitral valve; and

locking the suture so as to maintain the posterior leaflet in the repositioned position.

43. The method of claim 42, further comprising the steps of:

introducing a guide wire into the gutter region of the heart at an intersection of the posterior leaflet of the mitral valve and the left ventricular wall until the guide wire forms an arc shape along the contour of the left ventricular wall in the gutter region,

wherein the step of positioning the catheter includes deploying the catheter over the guide wire.

44. A method for performing an annuloplasty procedure, comprising the steps of:

introducing a catheter into a gutter region of heart tissue that is a region formed by the intersection of a posterior leaflet of a mitral valve and a left ventricular wall until the catheter forms an arc shape along a contour of the left ventricular wall in the gutter region;

deploying a plurality of anchors into the heart tissue from the catheter, wherein the anchors are connected by at least one suture;

applying tension to the at least one suture to cause the anchors to be drawn closer together, thereby creating plications in the heart tissue; and

applying a lock to the suture so as to maintain the position of the anchors and the plications in the heart tissue.

45. The method of claim 44, further comprising the steps of:

introducing a guide wire into the gutter region of the heart at an intersection of the posterior leaflet of the mitral valve and the left ventricular wall until the guide wire forms an arc shape along the contour of the left ventricular wall in the gutter region,

wherein the step of positioning the catheter includes deploying the catheter over the guide wire.