Suturing devices and methods for suturing an anatomic valve

• US 10,610,216 B2
• Filed: 04/28/2017
• Issued: 04/07/2020
• Est. Priority Date: 04/15/2011
• Status: Active Grant

• Current Assignee: Heartstitch, Inc
• Original Assignee: Heartstitch, Inc
• Inventors: Nobles, Anthony A., Brosch, Benjamin G., Cohn, William Ettlinger
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US15/582,079
• Publication Number:
  US 20170296168A1
• Time in Patent Office: 1,075 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185

Abstract

Suturing apparatuses configured to suture biological tissue, such as an anatomical valve. The suturing apparatuses can comprise an elongate member having a proximal end, a distal end, one or more arms, and one or more needles. A protective member may be used to inhibit contact between a distal end of a needle and surrounding tissue. Methods for suturing bodily tissue such as an anatomical valve may be performed with the suturing apparatuses. The suturing apparatuses may be used to suture adjacent valve leaflets or the base of a valve in order to treat or repair the valve.

Claims

1. A method of suturing an anatomic valve, comprising:

positioning a suturing device comprising an elongate body through the valve;

extending a plurality of arms from the elongate body of the suturing device, each of the arms carrying an end of a suture;

positioning at least a pair of arms at or near a base of the valve;

extending a protection member from the elongate body toward a first one of the arms positioned at or near a base of the valve;

advancing a needle through the protection member, through tissue of the valve at a first location, and into contact with a first one of the suture ends carried by the first arm;

retracting the needle through the tissue of the valve to draw the first suture end through the tissue;

rotating the protection member along the elongate body such that the protection member extends toward a second one of the arms positioned at or near a base of the valve;

advancing a needle through the protection member, through tissue of the valve at a second location, and into contact with a second one of the suture ends carried by the second arm;

retracting the needle through the tissue of the valve to draw the second suture end through the tissue; and

closing a distance between the first and second locations with said suture placed through said locations.

3. The method of claim 1, wherein the valve is a mitral valve.

4. The method of claim 1, further comprising delivering the suturing device through a transapical opening.

5. The method of claim 1, further comprising advancing the needles through tissue of a beating heart.

6. The method of claim 1, wherein each of the arms comprises a pair of suture mounts for releasably holding end portions of one or more sutures.

7. The method of claim 1, wherein the suturing device comprises six arms.

8. The method of claim 1, wherein extending a protection member comprises extending the protection member between adjacent chordae, and wherein the protection member remains between the adjacent chordae until the second suture end is drawn through the tissue.

2. A method of applying suturing to tissue, comprising:

providing a suturing device, the suturing device comprising a proximal end and a distal end, an elongate body extending between the proximal end and the distal end, and a handle at the proximal end;

delivering at least the distal end of the suturing device to a location adjacent the tissue;

extending a first arm and a second arm from the elongate body from a first position wherein the first arm and the second arm are retracted into the elongate body to a second position wherein the first arm and the second arm have free ends extending away from the elongate body and the first arm and the second arm form an angle between each other, the first arm carrying a first suture end and the second arm carrying a second suture end;

positioning the first and the second arm adjacent a first side of the tissue;

moving a needle arm from a retracted position wherein the needle arm is retracted into the elongate body to an extended position wherein the needle arm extends toward the first arm, the needle arm being located on the opposite side of the tissue from the first arm and the second arm;

advancing a first needle out of the needle arm, through the tissue at a first location, and into contact with the first suture end;

retracting the first needle through the tissue to draw the first suture end through the tissue, a first length of suture running from the first suture end and through the tissue;

rotating the needle arm toward the second arm such that the needle arm extends toward the second arm;

advancing a second needle out of the needle arm, through the tissue at a second location, and into contact with the second suture end;

retracting the second needle through the tissue to draw the second suture end through the tissue, a second length of suture running from the second suture end and through the tissue;

moving the needle arm back to the retracted position;

moving the first and second arms from the second position back to the first position; and

withdrawing the suturing device from the tissue location, the first and second lengths of suture remaining within the tissue.

9. The method of claim 2, wherein the location is a mitral valve.

10. The method of claim 9, further comprising delivering the suturing device transapically into the left ventricle of the heart, and wherein positioning the first and the second arm at or near a base of the valve comprises positioning the first and the second arm at or near a base of the valve on the atrial side of the valve.

11. The method of claim 2, further comprising closing a distance between the first and second locations using a suture placed between the first and second locations.

12. The method of claim 2, wherein the angle between the first arm and the second arm when extended is approximately 90 degrees.

13. The method of claim 2, wherein the first suture end and second suture end are ends of the same suture.

14. The method of claim 2, wherein the first suture end and second suture end are ends of different sutures.

15. The method of claim 2, wherein the needle arm is moved from a retracted position first to an initial extended position between the first arm and the second arm.

16. The method of claim 15, wherein the initial extended position is between adjacent chordae, and wherein the protection member remains between the adjacent chordae until the second suture end is drawn through the tissue.