Suturing devices and methods for closing a patent foramen ovale

• US 10,182,802 B2
• Filed: 09/10/2015
• Issued: 01/22/2019
• Est. Priority Date: 03/29/2007
• Status: Active Grant

• Current Assignee: Scarab Technology Services, LLC
• Original Assignee: Nobles Medical Technologies, Inc
• Inventors: Nobles, Anthony A., Brosch, Benjamin G., Decker, Steven E., Mullen, Michael J.
• Primary Examiner(s): SCHERBEL, TODD J
• Application Number:
  US14/850,210
• Publication Number:
  US 20150374351A1
• Time in Patent Office: 1,230 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 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;

at least a first suture catch mechanism slidably housed in said elongate body and configured to exit the elongate body through an opening in the elongate body, the first suture catch mechanism being movable in a proximal-to-distal direction 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 and prior to engagement with the first suture catch mechanism, the first suture clasp arm in the extended position forming an acute angle with a longitudinal axis of the elongate body, the acute angle facing the opening on the elongate body;

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 moveable in a distal-to-proximal direction 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 and prior to engagement with the second suture catch mechanism.

2. The suturing apparatus of claim 1, wherein the acute angle is between about 35-55°

.

3. The suturing apparatus of claim 1, wherein the second suture clasp arm in the extended position forms a second acute angle with the longitudinal axis of the elongate body, the second acute angle facing a second opening on the elongate body, wherein the second opening allows the second suture catch mechanism to exit 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.

4. The suturing apparatus of claim 1, wherein the elongate body is configured to house two guide wires therein.

5. The suturing apparatus of claim 1, further comprising a guide wire guide to direct a guide wire away from a longitudinal axis of the elongate body.

6. The suturing apparatus of claim 1, wherein at least one of the first and second suture clasp arms comprises a deflector configured to direct at least one of the first and second suture catch mechanisms into engagement with the first suture end portion.

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

8. The suturing apparatus of claim 7, wherein the distal end of the first needle comprises a groove for engaging an end portion of a suture.

9. The suturing apparatus of claim 1, further comprising at least a first guide configured to guide the first suture catch mechanism toward the first suture end portion held by the first suture clasp arm when the first suture clasp arm is in the extended position, the first guide located within the elongate body and terminating at the opening.

10. The suturing apparatus of claim 1, wherein the first and second suture clasp arms are configured to be extended simultaneously.

11. The suturing apparatus of claim 1, further comprising a first actuator which drives said first suture catch mechanism, and a second actuator which drives said second suture catch mechanism.

12. The suturing apparatus of claim 11, wherein said first and second actuators are configured to be non-simultaneously deployed.

13. The suturing apparatus of claim 1, 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 assembly 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.

14. The suturing apparatus of claim 1, wherein a distal portion of the second suture catch mechanism comprises a turned portion that is bent approximately 180 degrees, the turned portion configured to allow the distal end of the second suture catch mechanism to engage the second suture end portion when the second suture mechanism moves in the distal-to-proximal direction.