Device and method for suturing intracardiac defects

• US 10,245,022 B2
• Filed: 10/12/2015
• Issued: 04/02/2019
• Est. Priority Date: 09/26/2003
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories
• Original Assignee: Abbott Laboratories
• Inventors: McIntosh, Scott A.
• Primary Examiner(s): Holwerda, Kathleen
• Application Number:
  US14/880,894
• Publication Number:
  US 20160135803A1
• Time in Patent Office: 1,268 Days
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0491 Sewing machines for surgery
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• 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 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

In accordance with the present invention there is provided a suturing device. The suturing device includes a length of suture that will be delivered to the site of the PFO and placed through the tissue adjacent the opening to close the PFO. As described in greater detail below, the suture is advanced through the tissue surrounding the opening by a pair of needles that penetrate the tissue adjacent to the opening. A knot is then loosely tied with the length of suture and advanced to the site of the PFO. The tails of the suture extending from the knot are then cut and removed. It is also contemplated that a pre-formed or pre-tied knot may be disposed on the device, wherein after deployment of the suture through the tissue adjacent to the PFO and removal of the device a loop of suture having a pre-tied knot will remain, wherein the pre-tied knot may then be tightened to close the PFO. Further still it is contemplated that other means may be utilized to retain the sutures. For example, it is contemplated that a suture clip or other clip like device may be utilized to retain the suture in a position such that the PFO is closed.

Claims

1. A method for closing a septal defect, the method comprising:

following positioning one of a proximal facing surface or a distal facing surface of a first extendable locating foot to engage but not penetrate septal tissue forming the septal defect in a first atrium communicating with one end of a tunnel of the septal defect, advancing a first needle toward the first extendable locating foot to advance a suture material portion through the septal tissue;

following positioning a facing surface of a second extendable locating foot in a second atrium communicating with another end of the tunnel of the septal defect, the first atrium being different from the second atrium, the second extendable locating foot engaging but not penetrating septal tissue forming the septal defect in the second atrium, and the facing surface facing oppositely to the one of the proximal facing surface or the distal facing surface of the first extendable locating foot engaging with the septal tissue, advancing a second needle towards the second extendable locating foot to advance other suture material portion through the septal tissue; and

securing the suture material portion and the other suture material portion to close a septal defect,

wherein, the first needle is advanced from the second atrium to enter the first atrium to advance the suture material through the septal tissue and the second needle is advanced from the first atrium to the second atrium to advance the other suture material portion through the septal tissue.

2. The method of claim 1, wherein the first extendable member pivots relative to an elongate locating foot.

3. The method of claim 1, wherein the second extendable member pivots relative to an elongate locating foot.

4. The method of claim 1, wherein advancing the suture material portion through the septal tissue comprises drawing the suture material portion proximally through the septal tissue.

5. A method for closing a septal defect, the method comprising:

positioning a first extendable member in a first atrium and against a septum secundum, a portion of a septum primum and a portion of a tunnel between the septum secundum and the septum primum being disposed between the first extendable member and a portion of the septum primum, the first extendable member being disposed on an opposite side of the septal defect from a first advanceable needle that is advanceable toward the first extendable member;

advancing a suture material portion through the septum secundum;

following positioning a second extendable member against tissue in a second atrium communicating with another end of the tunnel, the first atrium being different from the second atrium, and the second extendable member being disposed on an opposite side of the septal defect from a second advanceable needle that is advanceable toward the second extendable member, advancing other suture material portion through the tissue; and

securing the suture material portion to close the septal defect.

6. The method of claim 5, wherein advancing the suture material portion through the septum secundum comprises advancing the suture material proximally through the septum secundum.

7. The method of claim 5, wherein positioning the second extendable foot member against tissue in the second atrium comprises positioning the second extendable member against the septum primum.

8. The method of claim 5, further comprising advancing a toggle through the septum primum.

9. The method of claim 8, further comprising securing the suture material portion with the toggle.

10. A method for closing a septal defect, the method comprising:

positioning a first extendable foot, in a deployed extending configuration, in a first atrium communicating with one end of a tunnel of the septal defect, the first extendable foot engaging without penetrating septal tissue forming the septal defect;

advancing a first needle towards the first extendable foot to advance a suture material portion through the septal tissue;

positioning a second extendable foot, in a deployed, extending configuration, in a second atrium, the first atrium being different from the second atrium, and the second extendable foot engaging without penetrating other septal tissue forming the septal defect;

advancing a second needle towards the second extendable foot to advance another suture material portion through the other septal tissue; and

securing the suture material portion to close the septal defect,

wherein, the first needle is advanced from the second atrium to enter the first atrium to advance the suture material through the septal tissue and the second needle is advanced from the first atrium to the second atrium to advance the other suture material portion through the septal tissue.

11. The method for closing the septal defect of claim 10, wherein positioning the first extendable foot comprises positioning the first extendable foot against a proximal surface of a septum secundum.

12. The method for closing the septal defect of claim 10, wherein securing the suture material portion comprises advancing a slidable toggle along the suture.

13. The method for closing the septal defect of claim 10, wherein the suture material portion comprises a fixed toggle and a slidable toggle.

14. The method for closing the septal defect of claim 10, further comprising advancing a portion of an elongate member supporting the first extendable foot through a tunnel between a septum secundum and a septum primum.

15. The method for closing the septal defect of claim 14, wherein a bight of the suture material portion is supported by the elongate member.

16. The method for closing the septal defect of claim 10, wherein positioning the first extendable foot comprises moving an actuation wire, connected to the first extendable foot, proximally.