Suture and method for repairing a heart

• US 10,154,838 B2
• Filed: 01/10/2017
• Issued: 12/18/2018
• Est. Priority Date: 02/14/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Solem, Jan Otto
• Primary Examiner(s): Miles, Jonathan
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US15/402,603
• Publication Number:
  US 20170119368A1
• Time in Patent Office: 707 Days
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• 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 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/0086 : for preferentially controlling or promoting the growth of specific types of cells or tissues
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/009 : magnetic

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.

Claims

1. A method for treating a heart in a patient, the method 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 away from the central body, wherein during advancing of the distal end portion the radially extendable elements are in the delivery configuration within the distal end sheath;

deploying the anchor into contact with heart tissue at the first location and transforming the anchor 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 at 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 the clip by sliding the elongate member within the clip so 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 between the clip and the elongate member; and

removing the delivery catheter from the patient.

2. The method of claim 1, wherein the radially extendable elements have sharp points at distal ends of the radially extendable elements, and 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 the elongate member are implanted in the patient via a transapical approach.

7. A method of improving heart function in a human heart, the method 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 includes radially-extendable elements, wherein the radially-extendable elements are held in a radially restrained condition;

deploying the radially-expandable device at a first location within the human heart by extending the radially-extendable elements radially outward to engage the device 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 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 extending the radially extendable elements radially outward includes ejecting the radially-expandable device out of the distal end of the catheter.

9. The method of claim 7, wherein the radially-extendable elements include prongs with sharp ends, and wherein engaging the device with heart tissue at the first location includes passing the sharp ends into the tissue at the first location.

10. The method of claim 7, wherein the surface of the radially-extendable elements is configured to promote tissue ingrowth.

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

12. 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.

13. 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.

14. A method of repairing heart function, the method 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 within the distal end of the catheter, wherein the expandable device is configured to be anchored to heart tissue with a plurality of radially-extendable elements movable between a delivery configuration in which the radially-extendable elements are retracted, and a deployed configuration in which the radially-extendable elements extend radially outward from the expandable device;

positioning the distal end of the catheter adjacent a first location in the heart;

extending the radially-extendable elements outwardly to engage heart tissue at the first location in the heart;

pulling on a proximal portion of an elongate member extending outside of an apex of the heart to adjust a length of the elongate member extending between the apex and the expandable device; and

positioning a locking clip against an outside surface of the heart at the heart apex with the elongate member locked in the locking clip to fix the length of the elongate member extending between the apex and the expandable device.

15. The method of claim 14, wherein the first location is within a left ventricle of the heart.

16. The method of claim 14, wherein the first location is at an exterior wall of the heart.

17. The method of claim 14, further comprising:

actively monitoring heart function prior to positioning the locking clip against an outside surface of the heart at the heart apex with the elongate member locked in the locking clip.

18. The method of claim 14, wherein the radially-extendable elements includes prongs with sharp ends, and wherein deploying the expandable device includes passing the sharp ends into heart tissue at the first location.