Suturing devices and methods for closing a patent foramen ovale

• US 9,131,938 B2
• Filed: 02/07/2013
• Issued: 09/15/2015
• Est. Priority Date: 03/29/2007
• Status: Active Grant

• Current Assignee: Scarab Technology Services, LLC
• Original Assignee: Nobles Medical Technologies, Inc (Medtronic Plc)
• Inventors: Nobles, Anthony A., Brosch, Benjamin G., Decker, Steven E., Mullen, Michael J.
• Primary Examiner(s): Miles, Jonathan W
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US13/761,683
• Publication Number:
  US 20130238001A1
• Time in Patent Office: 950 Days
• Field of Search: 606/139, 606144-150
• US Class Current: 1/1
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• 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
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments

Abstract

Methods and apparatuses are disclosed for closing a patent foramen ovale. Some of the disclosed apparatuses include an elongate body having a proximal end and a distal end, with first and second suture clasp arms adapted to hold end portions of a suture when in an extended position. A first suture catch mechanism is slidably housed in the elongate body and moves in a proximal-to-distal direction to engage the suture end held by the first suture clasp arm, and a second suture catch mechanism is slidably housed in the elongate body and moves in a distal-to-proximal direction to suture end held by the second suture clasp arm. The first suture clasp arm can be positioned around the septum primum to deliver a suture thereto, and the second suture clasp arm can be positioned around the septum secundum to deliver a suture thereto.

Claims

1. A method of closing a patent foramen ovale in a heart, the patent foramen ovale having a septum primum and a septum secundum, the method comprising:

delivering a first elongate body having a proximal end and a distal end to a location adjacent the patent foramen ovale, the first elongate body comprising a first suture clasp arm near the distal end holding a first suture end portion, the first elongate body being delivered at least partially over a first guidewire;

advancing a second guidewire distally from an opening in the first elongate body proximal to the first suture clasp arm, wherein when the second guidewire is advanced and when the first elongate body is in the location adjacent the patent foramen ovale, the second guidewire is positioned on one side of the septum secundum and the first elongate body is positioned on the other side of the septum secundum;

extending the first suture clasp arm from the first elongate body and positioning the first suture clasp arm so that the septum secundum is located between the first elongate body and the first suture clasp arm;

advancing a first needle through tissue of the septum secundum and into engagement with the first suture end portion held in the first suture clasp arm;

retracting the first needle through tissue of the septum secundum with the first suture end portion;

delivering a second elongate body discrete from the first elongate body having a second suture clasp arm to the tunnel of the patent foramen ovale;

positioning the second suture clasp arm around the septum primum, the second suture clasp arm holding a second suture end portion;

advancing a second needle through tissue of the septum primum and into engagaement with the second suture end portion held in the second suture clasp arm; and

retracting the second needle through tissue of the septum primum with the second suture end portion.

2. The method of claim 1, wherein the second suture clasp arm extends from the second elongate body.

3. The method of claim 1, further comprising drawing the septum primum and septum secundum closed.

4. The method of claim 1, wherein the second needle is advanced and retracted through tissue of the septum primum before the first needle is advanced and retracted through tissue of the septum secundum.

5. The method of claim 1, wherein after the second guidewire is advanced distally from the opening in the first elongate body, the first elongate body is further advanced to direct the elongate body toward the septum secundum.

6. The method of claim 1, wherein delivering the first elongate body to the location adjacent the patent foramen ovale comprises delivering the first elongate body into the tunnel of the patent foramen ovale.

7. The method of claim 1, wherein delivering the first elongate body to the location adjacent the patent foramen ovale comprises delivering the first elongate body into the superior vena cava.

8. The method of claim 1, wherein the second guidewire is positioned through the tunnel of the patent foramen ovale.

9. The method of claim 1, wherein the second guidewire is positioned only on the right atrial side of the septum secundum.

10. The method of claim 1, wherein the first suture clasp arm extends from the same side of the first elongate body as the opening from which the second guidewire is advanced.

11. The method of claim 1, wherein the first suture clasp arm extends distally from the first elongate body and the needle is advanced proximally through tissue of the septum secundum.

12. A method of closing a patent foramen ovale in a heart, the patent foramen ovale having a septum primum and a septum secundum, the method comprising:

delivering a first elongate body having a proximal end and a distal end to a location in the right atrium of the heart adjacent to the patent foramen ovale, the first elongate body comprising a first suture clasp arm near the distal end holding a first suture end portion, the first elongate body being delivered at least partially over a first guidewire advanced into the superior vena cava;

advancing a second guidewire distally from an opening in the first elongate body proximal to the first suture clasp arm through the patent foramen ovale between the septum primum and the septum secundum;

extending the first suture clasp arm from the first elongate body and positioning the first suture clasp arm so that the septum secundum is located between the first elongate body and the first suture clasp arm;

advancing a first needle through tissue of the septum secundum and into engagement with the first suture end portion held in the first suture clasp arm; and

retracting the first needle through tissue of the septum secundum with the first suture end portion;

delivering a second elongate body discrete from the first elongate body having a proximal end and a distal end to a location through the patent foramen ovale between the septum primum and the septum secundum, the second elongate body comprising a second suture clasp arm near the distal end holding a second suture end portion, the second elongate body being delivered at least partially over a guidewire advanced through the patent foramen ovale between the septum primum and the septum secundum;

extending the second suture clasp arm from the second elongate body and positioning the second suture clasp arm so that the septum primum is located between the second elongate body and the second suture clasp arm;

advancing a second needle through tissue of the septum primum and into engagement with the second suture end portion held in the second suture clasp arm; and

retracting the second needle through tissue of the septum primum with the second suture end portion.

13. The method of claim 12, wherein the second elongate body is through the patent foramen ovale and the second needle is advanced and retracted through tissue of the septum primum before the first elongate body is delivered.

14. The method of claim 12, further comprising drawing the septum primum and septum secundum together using suture portions advanced through tissue of the septum primum and the septum secundum.