Suturing Devices and Methods for Closing a Patent Foramen Ovale

• US 20080269786A1
• Filed: 03/27/2008
• Published: 10/30/2008
• Est. Priority Date: 03/29/2007
• Status: Active Grant

• Current Assignee: Gary S. Kohler, Pandora Select Partners, L.P., Scarab Technology Services, LLC, Scot W. Malloy
• Original Assignee: Nobles Medical Technologies, Inc
• Inventors: Decker, Steven E., Nobles, Anthony A., Brosch, Benjamin G., Mullen, Michael J.
• Granted Patent: US 8,246,636 B2
• Time in Patent Office: Days
• US Class Current: 606/145
• 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 J-shaped suture needles A61B2017/0608
• 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 suturing apparatus for suturing a patent foramen ovale, comprising:

an elongate body having a proximal end and a distal end configured to be delivered percutaneously into the patent foramen ovale;

at least a first suture clasp arm adapted to hold a first suture end portion, the first suture clasp arm being extendable from said body from a retracted position to an extended position and configured to be placed around one of the septum primum and septum secundum of the patent foramen ovale; and

at least a first suture catch mechanism slidably housed in said elongate body, the first suture catch mechanism being movable through one of the septum primum and septum secundum of the patent foramen ovale to engage a distal end of the first suture catch mechanism with the first suture end portion held by the first suture clasp arm when the first suture clasp arm is in the extended position.

2. The suturing apparatus of claim 1, further comprising:

at least a second suture clasp arm adapted to hold a second suture end portion, the second suture clasp arm being extendable from said body from a retracted position to an extended position and configured to be placed around the other of the septum primum and septum secundum of the patent foramen ovale; and

a second suture catch mechanism slidably housed in said elongate body, the second suture catch mechanism being moveable through the other of the septum primum and septum secundum of the patent foramen ovale to engage a distal end of the second suture catch mechanism with the second suture end portion held by the second suture clasp arm when the second suture clasp arm is in the extended position.

3. The suturing apparatus of claim 2, wherein the first suture catch mechanism is moveable in a proximal-to-distal direction to engage the distal end of the first suture catch mechanism with the first suture end portion held by the first suture clasp arm when the first suture clasp arm is in the extended position.

4. The suturing apparatus of claim 3, wherein the second suture catch mechanism is moveable in a distal-to-proximal direction to engage the distal end of the second suture catch mechanism with the second suture end portion held by the second suture clasp arm when the second suture clasp arm is in the extended position.

5. The suturing apparatus of claim 1, wherein the first suture clasp arm forms an acute angle with a longitudinal axis of the elongate body.

6. The suturing apparatus of claim 1, wherein the first suture clasp arm is configured to extend between about 35-55°

from a longitudinal axis of the elongate body.

7. The suturing apparatus of claim 2, wherein the first and second suture clasp arms form acute angles with a longitudinal axis of the elongate body, the first suture clasp arm having a distal end that extends generally proximally in its extended position, and the second suture clasp arm having a distal end that extends generally distally in its extended position.

8. The suturing apparatus of claim 1, wherein the elongate body is configured to house two guidewires therein.

9. The suturing apparatus of claim 1, wherein the suture clasp arm comprises a guidewire guide to direct a guidewire away from a longitudinal axis of the elongate body.

10. The suturing apparatus of claim 1, wherein the suture clasp arm comprises a deflector configured to direct the suture catch mechanism into engagement with the first suture end portion.

11. The suturing apparatus of claim 1, wherein the first suture catch mechanism comprises a first needle.

12. The suturing apparatus of claim 11, wherein the distal end of the first needle comprises a groove for engaging an end portion of a suture.

13. The suturing apparatus of claim 1, further comprising at least a first guide configured to guide the first suture catch mechanism toward the suture clasp on the first suture clasp arm when the first suture clasp arm is in the extended position.

14. A kit for suturing a patent foramen ovale comprising the suturing apparatus of claim 1 and a second suturing apparatus, the second suturing apparatus comprising:

a second elongate body having a proximal end and a distal end configured to be delivered percutaneously into the patent foramen ovale;

at least a second suture clasp arm adapted to hold a second suture end portion, the second suture clasp arm being extendable from said body from a retracted position to an extended position and configured to be placed around the other of the septum primum and septum secundum of the patent foramen ovale; and

at least a second suture catch mechanism slidably housed in said elongate body, the second suture catch mechanism being movable through the other of the septum primum and septum secundum to engage a distal end of the second suture catch mechanism with the second suture end portion held by the second suture clasp arm when the first suture clasp arm is in the extended position.

15. The kit of claim 14, wherein the first suture catch mechanism moves toward the distal end of the suturing apparatus of claim 1 when moving to engage the distal end of the first suture clasp arm, and the second suture catch mechanism moves toward the proximal end of the second suturing apparatus when moving to engage the second suture clasp arm.

16. A system for suturing a patent foramen ovale, comprising a first suturing apparatus and a second suturing apparatus;

the first suturing apparatus comprising;

a first elongate body having a proximal end and a distal end;

a first suture clasp arm adapted to hold a first suture end portion, the first suture clasp arm being extendable from said body from a retracted position to an extended position and configured to be placed around the septum primum of the patent foramen ovale, and

a first suture catch mechanism slidably housed in said elongate body, the first suture catch mechanism being moveable in a proximal to distal direction through the septum primum of the patent foramen ovale to engage a distal end of the first suture catch mechanism with the first suture end portion held by the first suture clasp arm when the first suture clasp arm is in the extended position; and

the second suturing apparatus comprising;

a second elongate body having a proximal end and a distal end;

a second suture clasp arm adapted to hold a second suture end portion, the second suture clasp arm being extendable from said body from a retracted position to an extended position and configured to be placed around the septum secundum of the patent foramen ovale;

a second suture catch mechanism slidably housed in said elongate body, the second suture catch mechanism being moveable in a distal-to-proximal direction through the septum secundum of the patent foramen ovale to engage a distal end of the second suture catch mechanism with the second suture end portion held by the second suture clasp arm when the second suture clasp arm is in the extended position.

17. A suturing apparatus for suturing a patent foramen ovale, comprising:

an elongate body having a proximal end and a distal end;

a first suture clasp arm adapted to hold a first suture end portion, the first suture clasp arm being extendable from said body from a retracted position to an extended position and configured to be placed around the septum primum of the patent foramen ovale;

a second suture clasp arm adapted to hold a second suture end portion, the second suture clasp arm being extendable from said body from a retracted position to an extended position and configured to be placed around the septum secundum of the patent foramen ovale;

a first suture catch mechanism slidably housed in said elongate body, the first suture catch mechanism being moveable in a proximal-to-distal direction through the septum primum of the patent foramen ovale to engage a distal end of the first suture catch mechanism with the first suture end portion held by the first suture clasp arm when the first suture clasp arm is in the extended position; and

a second suture catch mechanism slidably housed in said elongate body, the second suture catch mechanism being moveable in a distal-to-proximal direction through the septum secundum of the patent foramen ovale to engage a distal end of the first suture catch mechanism with the second suture end portion held by the second suture clasp arm when the second suture clasp arm is in the extended position.

18. The suturing apparatus of claim 17, wherein the first and second suture clasp arms are configured to be extended simultaneously.

19. The suturing apparatus of claim 17, further comprising a first actuator which drives said first suture catch mechanism, and a second actuator which drives said second suture catch mechanism.

20. The suturing apparatus of claim 17, wherein said first and second actuators are configured to be non-simultaneously deployed.

21. The suturing apparatus of claim 17, wherein said elongate body further comprises:

an elongate tubular member having a plurality of lumens extending therethrough;

a spreader assembly mounted to said elongate body, said spreader having a plurality of lumens extending therethrough; and

a distal tip mounted to said spreader assembly;

wherein said plurality of spreader lumens are aligned with said plurality of tubular member lumens to form a plurality of continuous passageways through said elongate tubular member and said spreader assembly.

22. A method of closing a patent foramen ovale having a septum primum and a septum secundum, comprising:

positioning a first suture clasp arm around one of the septum primum and the septum secundum, the first suture clasp arm holding a first suture end portion;

advancing a first needle through tissue of one of the septum primum and 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 one of the septum primum and septum secundum with the first suture end portion carried by the first needle;

positioning a second suture clasp arm around the other of the septum primum and the septum secundum, the second suture clasp arm holding a second suture end portion;

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

retracting the second needle through tissue of the other of the septum primum and septum secundum with the second suture end portion; and

drawing the septum primum and the septum secundum closed.

23. The method of claim 22, wherein the first needle is advanced in a first direction and the second needle is advanced in a second direction, the second direction being generally opposite to the first direction.

24. The method of claim 22, wherein the first suture clasp arm is positioned over the septum primum, and the second suture clasp arm is positioned over the septum secundum.

25. The method of claim 24, wherein the first suture clasp arm is positioned over the septum primum before the second suture clasp arm is positioned over the septum secundum.

26. The method of claim 22, wherein drawing the septum primum and the septum secundum closed comprises applying a knot to the first suture end portion and second suture end portion.

27. The method of claim 26, further comprising applying a second knot to the first suture end portion and second suture end portion.

28. The method of claim 22, further comprising applying a patch to the patent foramen ovale delivered over the suture end portions.

29. The method of claim 22, wherein the first and second suture clasp arms extend from an elongate body delivered percutaneously into the tunnel of the patent foramen ovale, and wherein the first suture clasp arm in its extended position forms an acute angle with a longitudinal axis of the elongate body, and extends in a proximal direction, and the second suture clasp arm in its extended position forms an acute angle with a longitudinal axis of the elongate body, and extends in a distal direction.

30. The method of claim 22, wherein the first suture clasp arm and first needle are provided in a first suturing apparatus, and the second suture clasp arm and second needle are provided in a second suturing apparatus, the first and second suturing apparatuses being separately delivered to the patent foramen ovale.

31. A method of closing a patent foramen ovale having a septum primum and a septum secundum, comprising:

advancing a first elongate body into a tunnel of a patent foramen ovale;

extending a first suture clasp arm from the first elongate body from a retracted position to an extended position, the first suture clasp arm holding a first suture end portion;

positioning the first suture clasp arm around one of the septum primum and the septum secundum;

advancing a first needle positioned in the elongate body outwardly from the body through tissue of one of the septum primum and septum secundum and into engagement with the first suture end portion held in the first suture clasp arm;

retracting the first needle into the first elongate body with the first suture end portion carried by the first needle;

withdrawing the first elongate body from the tunnel of the patent foramen ovale;

advancing a second elongate body near the tunnel of a patent foramen ovale;

extending a second suture clasp arm from the second elongate body from a retracted position to an extended position, the second suture clasp arm holding a second suture end portion;

positioning the second suture clasp arm around the other of the septum primum and the septum secundum;

advancing a second needle positioned in the second elongate body outwardly from the body through tissue of the other of the septum primum and septum secundum and into engagement with the second suture end portion held in the second suture clasp arm;

retracting the second needle into the second elongate body with the second suture end portion carried by the second needle;

withdrawing the second elongate body from the tunnel of the patent foramen ovale; and

drawing the septum primum and the septum secundum closed.

32. The method of claim 31, wherein the elongate body is advanced over a guidewire into the tunnel of the patent foramen ovale.

33. The method of claim 32, further comprising advancing a second guidewire into the superior vena cava, and advancing the elongate body over the second guidewire.

34. The method of claim 31, wherein the elongate body is advanced over a guidewire toward the superior vena cava when positioning the first or second suture clasp arms around the septum secundum.

35. The method of claim 34, further comprising advancing a second guidewire into the tunnel of the patent foramen ovale, and advancing the elongate body over the second guidewire to place one of the first and second suture clasp arms around the septum secundum.

36. The method of claim 31, further comprising:

advancing a third elongate body near the tunnel of a patent foramen ovale;

extending a third suture clasp arm from the third elongate body from a retracted position to an extended position, the third suture clasp arm holding a third suture end portion;

positioning the third suture clasp arm around the other of the septum primum and the septum secundum;

advancing a third needle positioned in the third elongate body outwardly from the body through tissue of the other of the septum primum and septum secundum and into engagement with the third suture end portion held in the third suture clasp arm;

retracting the third needle into the second elongate body with the third suture end portion carried by the second needle;

withdrawing the third elongate body from the tunnel of the patent foramen ovale.