Closure devices and methods

• US 10,537,313 B2
• Filed: 11/07/2016
• Issued: 01/21/2020
• Est. Priority Date: 01/09/2009
• Status: Active Grant

• Current Assignee: Abbott Vascular Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Vascular Incorporated (Abbott Laboratories)
• Inventors: Gianotti, Marc G., Fortson, Aaron M.
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US15/344,978
• Publication Number:
  US 20170049426A1
• Time in Patent Office: 1,170 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 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments

Abstract

A method for closing a puncture in a vessel wall of a blood vessel that includes advancing a guide member into proximity with a puncture in a vessel wall, positioning a distal end of an angle adjustment member distal to openings of the guide member, deploying the needle guides from the guide member through the openings, advancing the deflected needle guides and the suture securing devices through the vessel wall, retracting the needle guides to release the suture securing devices distally of the vessel wall, and establishing tension in the sutures to move the suture securing devices toward each other to thereby close the puncture.

Claims

1. A method for closing a puncture in a vessel wall of a blood vessel, the method comprising:

advancing a guide member into proximity with a puncture in a vessel wall, the guide member having a proximal end, a distal end, openings near the distal end, and a plurality of needle guides disposed within the guide member, each needle guide comprises a suture attached to a suture securing device;

positioning a distal end of a needle guide angle adjuster distal to the openings of the guide member, the needle guide angle adjuster being slidably coupled to the guide member;

advancing an anchor through the guide member and distally away from the distal end of the guide member and expanding the anchor distally of the puncture before deploying the needle guides, wherein the anchor is expanded to laterally extend beyond a deployment location of at least one of the suture securing devices to be advanced through the vessel wall;

deploying the needle guides distally and radially away from the guide member through the openings;

deflecting the needle guides with the needle guide angle adjuster;

advancing the deflected needle guides and the suture securing devices through the vessel wall to the deployment location;

retracting the needle guides to release the suture securing devices distally of the vessel wall; and

establishing tension in the sutures to move the suture securing devices toward each other to thereby close the puncture.

2. The method of claim 1, wherein the needle guides are deployed distally and radially away from the guide member through the openings and advance through the vessel wall by moving an activation handle relative to the guide member.

3. The method of claim 1, further comprising positioning a plug against the vessel wall.

4. The method of claim 1, wherein the suture securing device comprises:

an elongated body having a proximal end, a distal end, and an inner cavity;

a first opening in the proximal end of the elongated body, the first opening being in communication with the inner cavity;

a cutout having a periphery extending distally from the first opening;

a plurality of tissue-engaging elements at least partially surrounding the cutout; and

the suture attached to the elongated body.

5. The method of claim 4, further comprising moving the elongated body between a first position wherein the elongated body is substantially parallel with a longitudinal axis of the suture and a second position wherein the elongated body is substantially non-parallel with the longitudinal axis of the suture and at least a portion of the suture is received within the cutout such that the elongated body can resist proximal movement against a distal surface of a vessel wall.

6. The method of claim 4, further comprising engaging the plurality of tissue-engaging elements against the vessel wall.

7. The method of claim 1, wherein the suture securing device comprises a tapered body.

8. A method for closing a puncture in a vessel wall of a blood vessel, the method comprising:

advancing a guide member into proximity with a puncture in a vessel wall, the guide member comprising a needle guide comprising a securing device;

advancing an anchor through the guide member to a deployment location within the blood vessel;

expanding the anchor to laterally extend beyond a deployment location of the securing device to be advanced through the vessel wall;

positioning a distal end of a needle guide angle adjuster distal to openings of the guide member and distal to a distal end of the guide member;

the needle guide angle adjuster being slidably coupled to the guide member,

deploying the needle guide distally and radially away from the guide member;

deflecting the needle guide with the needle guide angle adjuster;

advancing the needle guides and the securing device through the vessel wall to the deployment location of the securing device;

retracting the needle guide to release the securing device distally of the vessel wall; and

moving the securing device toward a longitudinal axis of the guide member to close the puncture.

9. The method of claim 8, further comprising actuating a handle relative to the guide member to deploy the needle guide distally.

10. The method of claim 8, further comprising positioning a plug against the vessel wall.

11. The method of claim 8, wherein at least a portion of the securing device rotates relative to the needle guide after the securing device is released from the needle guide.

12. A method for closing a puncture in a vessel wall of a blood vessel, the method comprising:

advancing a distal end of a guide member to position openings of the guide member, near the distal end, into proximity with a puncture in a vessel wall;

positioning a distal end of a needle guide angle adjuster distal to the openings of the guide member and distal to the distal end of the guide member, the needle guide angle adjuster being slidably coupled to the guide member;

deploying a plurality of needle guides distally and radially away from the guide member, each needle guide comprising a suture securing device, the suture securing device comprising;

an elongated body having a proximal end, a distal end, and an inner cavity;

a first opening in the proximal end of the elongated body, the first opening being in communication with the inner cavity;

a cutout having a periphery extending distally from the first opening;

a plurality of tissue-engaging elements at least partially surrounding the cutout; and

a suture attached to the elongated body;

advancing the needle guides and the suture securing device through the vessel wall;

penetrating the vessel wall by deflecting the needle guides away from a longitudinal axis of the guide member;

deploying each suture securing device from each needle guide of the plurality of needle guides to a deployment location;

moving the suture securing device toward the longitudinal axis of the guide member to close the puncture;

advancing an anchor through the guide member to a deployment location within the blood vessel; and

expanding the anchor to laterally extend beyond the deployment location of the securing device advanced through the vessel wall.

13. The method of claim 12, further comprising actuating a handle relative to the guide member to deploy the needle guide distally.

14. The method of claim 12, further comprising positioning a plug against the vessel wall.