Suture and method for repairing a heart

Patent metadata

Field	Value
Publication number	US-9572667-B2
Application number	US-201615232274-A
Country	US
Kind code	B2
Filing date	Aug 9, 2016
Priority date	Feb 14, 2007
Publication date	Feb 21, 2017
Grant date	Feb 21, 2017

Abstract

Devices and methods for treating or repairing a heart are disclosed. The device includes at least one radially expandable tissue-engaging element, an elongate member (e.g., suture) coupled to the expandable element, and a locking mechanism (e.g., locking clip, suture knot). The expandable element may be anchored to heart tissue within the heart, such as in the left ventricle, with the elongate member extending from the expandable element and across a heart chamber to a second location such as the heart apex where the elongate member is held by the locking mechanism.

First claim

What is claimed is:

1. A method for treating a heart in a patient, comprising:
advancing a distal end portion of a delivery catheter to a position adjacent heart tissue at a first location, wherein the distal end portion comprises a distal end sheath having an anchor therein, wherein the anchor is configured to radially expand from a delivery configuration to a tissue-engaging configuration, wherein the anchor comprises a central body having a central lumen and a plurality of radially extendable elements positioned around a circumference of a distal end of the central body, wherein in the delivery configuration the radially extendable elements are radially retracted, and wherein in the tissue-engaging configuration the radially expandable elements are radially extended in flowered fashion away from the central body, wherein the radially extendable elements are formed from nitinol, wherein during advancing of the distal end portion the radially extendable elements are compressibly held in the delivery configuration within the distal end sheath;
deploying the anchor into contact with heart tissue at the first location, comprising releasing the anchor from the sheath whereby the anchor transforms from the delivery configuration to the tissue-engaging configuration wherein the radially extendable elements radially extend away from the central body into contact with the heart tissue at the first location;
passing an elongate member from the first location, across a heart chamber, and through a heart wall, wherein a first end of the elongate member is secured to the anchor;
securing a clip to heart tissue at a second location, wherein the second location is an apex of the heart, wherein the clip is configured to slidingly receive the elongate member and to lock onto the elongate member to prevent sliding movement by the elongate member with respect to the clip, wherein the second location is on the opposite side of the heart wall from the first location, wherein the elongate member is slidingly received within the clip;
adjusting the length of the elongate member between the anchor and clip by sliding the elongate member within the clip such that the elongate member extends across the heart chamber and provides tension between the anchor and the clip;
locking the clip to the elongate member to prevent sliding movement therewith; and
removing the delivery catheter from the patient.

2. The method of claim 1 , wherein the radially extendable elements comprise sharp points at distal ends thereof, wherein deploying the anchor comprises passing the sharp points into the tissue at the first location.

3. The method of claim 1 , wherein the first location is in an exterior heart wall.

4. The method of claim 1 , wherein the heart chamber is a left ventricle.

5. The method of claim 4 , wherein the clip is positioned on the outside of the heart wall at the apex.

6. The method of claim 5 , wherein the anchor and elongate member are implanted in the patient via a transapical approach.

7. A method of improving heart function in a human heart, comprising:
advancing an elongate tensioning element and a radially-expandable device into a ventricle of a human heart via a catheter using a transapical approach, wherein the radially-expandable device is secured to a distal end of the elongate tensioning element, wherein the radially-expandable device comprises a memory-material frame defining a central orifice and radially-extendable elements, wherein the radially-extendable elements are held in a radially restrained condition by a restraining portion of the catheter, wherein the radially-extendable elements are configured to be biased via memory-material toward a radially expanded state such that the radially-extendable elements radially extend from the device in flower-like fashion when released from the catheter;
deploying the radially-expandable device at a first location within the human heart by releasing the radially-extendable elements from a restraining portion of the catheter, whereby the radially-extendable elements extend radially outward to engage the device into engagement with heart tissue at the first location;
selectively tensioning the elongate tensioning element within the heart by pulling on a proximal portion of the elongate tensioning element extending outside of the heart wall via an opening at the heart apex; and
placing a locking clip against an outside surface of the heart at the heart apex with the elongate tensioning element locked in the locking clip to thereby hold the elongate tensioning element in a desired level of tension between the locking clip and the radially-expandable device.

8. The method of claim 7 , wherein the restraining portion of the catheter comprises a distal end of the catheter, whereby releasing the radially-extendable elements from the catheter comprises ejecting the radially-expandable device out of the distal end of the catheter.

9. The method of claim 7 , wherein the radially-extendable elements comprise prongs having sharp ends, wherein deploying the radially-expandable device comprises passing the sharp ends into the tissue at the first location.

10. The method of claim 9 , wherein deploying the radially-expandable device comprises exposing the radially-extendable elements to the heart tissue.

11. The method of claim 10 , wherein the surface of the radially-extendable elements is configured to promote tissue ingrowth.

12. The method of claim 7 , wherein the first location is at a wall of the ventricle.

13. The method of claim 7 , further comprising:
actively monitoring heart function to confirm that proper tension is applied by the elongate tensioning element between the radially-expandable device and the locking clip.

14. The method of claim 7 , further comprising:
after placing the locking clip against an outside surface of the heart, cutting excess portions of the elongate tensioning element that extend proximally from the locking clip.

15. A method of repairing heart function, comprising:
advancing a distal end of a catheter into a heart of a patient via a transapical approach, wherein the distal end comprises a distal opening, wherein an expandable device is positioned and compressively restrained in a delivery configuration within the distal end of the catheter, wherein the expandable device is configured to be anchored to heart tissue, wherein a distal end of an elongate member is secured to the expandable device, the expandable device comprising a memory-metal frame defining a central lumen and a plurality of radially-extendable elements, wherein the plurality of radially-extendable elements are at a distal end of the memory-metal frame, wherein in the delivery configuration of the expandable device the radially-extendable elements are compressively restrained, and further comprises a deployed configuration wherein the radially-extendable elements extend radially outward from the central lumen, wherein the memory-metal frame is biased via memory-metal properties such that the radially-extendable elements when released from radial compression in the delivery configuration radially expand outward in flower-like fashion as the expandable device transitions from the delivery configuration into the deployed configuration;
positioning the distal end of the catheter adjacent a first position in the heart;
pushing the expandable device out of the distal end of the catheter, whereby the radially-extendable elements expand outwardly in flower-like fashion and the expandable device engages heart tissue at the first position in the heart;
pulling on a proximal portion of the elongate memb

Assignees

• Edwards Lifesciences Corp

Inventors

• Solem Jan Otto

Classifications

• A61B17/00234

  for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence) · CPC title

• A61B2017/06057

  Double-armed sutures, i.e. sutures having a needle attached to each end · CPC title

• A61B17/0401 Primary

  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 title

• A61B2017/003

  Steerable · CPC title

• A61F2/2466

  Delivery devices therefor · CPC title