Beating-heart mitral valve chordae replacement

• US 10,624,743 B2
• Filed: 04/19/2017
• Issued: 04/21/2020
• Est. Priority Date: 04/22/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Keidar, Yaron, Yestrepsky, Adam J.
• Primary Examiner(s): Stransky, Katrina M
• Assistant Examiner(s): Byrd, Brigid K
• Application Number:
  US15/491,809
• Publication Number:
  US 20170304050A1
• Time in Patent Office: 1,098 Days
• 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 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Methods and devices for the treatment of cardiac valve dysfunction through the placement of lines and anchors. The lines and anchors can form artificial chordae between valve leaflets and the ventricular wall or papillary muscles or connect the two valve leaflets together. The methods and devices offer a mechanism for performing this technique with the heart still beating, and allows for the placement of multiple lines with a single device.

Claims

1. A method comprising the steps of:

introducing into a ventricle of a heart proximate to a heart valve leaflet a catheter with a suction cup at a distal end, and a needle positioned within the catheter, wherein the needle comprises an opening;

contacting a ventricular side of the heart valve leaflet with a distal end of the suction cup;

partially axially collapsing the suction cup while engaging the ventricular side of the heart valve leaflet and applying a negative pressure through the suction cup to the ventricular side of the heart valve leaflet;

advancing the needle out of the suction cup to pierce the heart valve leaflet while applying the negative pressure to the ventricular side of the heart valve leaflet through the suction cup and partially axially collapsing the suction cup, wherein the heart valve leaflet is pierced by passing the portion of the needle with the opening through the heart valve leaflet;

deploying through the opening of the needle onto the atrial side of the heart valve leaflet a distal end of a line;

withdrawing the needle from the heart valve leaflet into the catheter such that a portion of the distal end of the line remains on the atrial side of the heart valve leaflet; and

releasing the negative pressure to remove the suction cup from the ventricular side of the heart valve leaflet.

2. The method of claim 1, wherein a first pledget is disposed at the distal end of the line, the method further comprising contacting the ventricular side of the heart valve leaflet with the suction cup and applying negative pressure a second time;

extending the needle out of the distal end of the suction cup;

piercing the heart valve leaflet with the line a second time while the negative pressure is applied the second time;

deploying through the opening of the needle onto the atrial side of the heart valve leaflet a second pledget, wherein the second pledget is slidably attached to the line;

withdrawing the needle from the heart valve such that the second pledget remains on the atrial side of the heart valve leaflet; and

removing the negative pressure and the suction cup from the ventricular side of the heart valve leaflet.

3. The method of claim 2, further comprising contacting the ventricular side of the heart valve leaflet with the suction cup and applying negative pressure a third time;

extending the needle out of the distal end of the suction cup;

piercing the heart valve leaflet with the needle a third time while the negative pressure is applied the third time;

deploying through the opening of the needle onto the atrial side of the heart valve leaflet a third pledget, wherein the third pledget is slidably attached to the line; and

withdrawing the needle from the heart valve such that the third pledget remains on the atrial side of the heart valve leaflet.

4. The method of claim 1, wherein a first pledget is disposed at the distal end of the line, the method further comprising withdrawing the needle from the ventricle of the heart;

anchoring the line to the heart;

reintroducing the needle into the ventricle of the heart proximate to one of the heart valve leaflet or a second heart valve leaflet;

applying a negative pressure to the heart valve leaflet or the second heart valve leaflet through the suction cup;

extending the needle out of the distal end of the suction cup;

contacting a ventricular side of the heart valve leaflet or the second heart valve leaflet with the needle;

piercing the heart valve leaflet or the second heart valve leaflet with the needle while the negative pressure is applied;

deploying through the opening of the needle onto the atrial side of the heart valve leaflet or the second heart valve leaflet a second pledget, wherein the second pledget is slidably attached to the line; and

withdrawing the needle from the heart valve leaflet or the second heart valve leaflet such that the second pledget and a portion of the distal end of the line remains on the atrial side of the heart valve leaflet or the second heart valve leaflet.

5. The method of claim 4, further comprising contacting the ventricular side of the heart valve leaflet or the second heart valve leaflet with the needle a second time;

applying a negative pressure to the heart valve leaflet or the second heart valve leaflet through the suction cup;

extending the needle out of the distal end of the suction cup;

deploying through the opening of the needle onto the atrial side of the heart valve leaflet or the second heart valve leaflet a third pledget, wherein the third pledget is slidably attached to the line; and

withdrawing the needle from the heart valve such that the third pledget remains on the atrial side of the heart valve leaflet or the second heart valve leaflet.

6. The method of claim 5, further comprising the step of deploying a connector attached to the line and stored in the needle after the needle is withdrawn from the heart valve leaflet or the second heart valve leaflet.

7. The method of claim 1, further comprising fixing a proximal portion of the line to the heart.