Tissue closure device and method

• US 10,058,314 B2
• Filed: 07/01/2014
• Issued: 08/28/2018
• Est. Priority Date: 01/20/2010
• Status: Expired due to Fees

• Current Assignee: Micro Interventional Devices, Inc.
• Original Assignee: Micro Interventional Devices, Inc.
• Inventors: Whitman, Michael P., Datcuk, Peter
• Primary Examiner(s): David, Shaun L
• Application Number:
  US14/321,476
• Publication Number:
  US 20140316458A1
• Time in Patent Office: 1,519 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 17/0401 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 17/0466 Suture bridges
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0408 : Rivets
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 : having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 : having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0427 : having anchoring barbs or pins extending outwardly from the anchor body
• 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 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/0618 : elastic, e.g. stretchable
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0645 : being elastically deformed for insertion
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2090/065 : for measuring contact or contact pressure

Abstract

A device having a plurality of anchors configured to be driven into a tissue, and a closure element extending between the anchors and configured to urge the anchors toward each other, closing a wound and complying with motion of the tissue.

Claims

1. A device, comprising:

a plurality of anchors, each including a flexible stem extending proximally from a distal end, the distal end tapers to a distal tip configured to pierce tissue;

at least one inelastic closure element coupled to the anchors, wherein the closure element includes a knot;

a driver configured to drive the anchors, with the closure element coupled to the anchors, into the tissue; and

a tensioner configured to tension the closure element sufficient to (i) urge the anchors toward each other to close at least one of an aperture and a distance in the tissue located between the anchors driven into the tissue and (ii) resist opposing forces exerted on the anchors that urge the anchors apart, wherein, as the closure element is drawn proximally through the tensioner, the tensioner moves distally into approximation with the knot,

wherein a proximal end of the tensioner is removable from a body of the tensioner, wherein the closure element is coupled to the removable proximal end of the tensioner such that when the proximal end of the tensioner is removed from the body of the tensioner, the proximal end is a grip to at least one of pull and draw on the closure element.

2. The device according to claim 1, wherein the opposing forces are exerted on the anchors by at least one of (a) the tissue, (b) a fluid flow, (c) pneumatic pressure, (d) hydraulic pressure, and (e) external forces.

3. The device according to claim 1, further comprising a safety release mechanism including a plurality of spring-loaded members, each spring-loaded member independently movable between an engagement position and a disengagement position, the safety release mechanism adapted to prevent the driver from driving the anchors unless all of the spring-loaded members are in the engagement position.

4. The device of claim 1, wherein the anchors each include at least one barb extending proximally and radially outwardly from the distal end to a free end, the at least one barb including a radially exterior surface and a radially interior surface;

wherein the radially exterior surface includes longitudinally extending corrugations providing a plurality of proximally extending projections at the free end; and

wherein the flexible stem is flexible with respect to the at least one barb and the distal tip.

5. The device of claim 1, wherein the closure element is a suture.

6. The device of claim 5, wherein the anchors each include an eyelet configured to receive the suture.

7. The device of claim 6, wherein a first end of the closure element is tied in the knot prior to the closure element being received through the eyelets.

8. The device of claim 7, wherein the tensioner includes a hollow axial interior core such that the closure element runs through the tensioner via the interior core such that the knot is larger than a distal opening of the interior core.

9. The device of claim 7, wherein a second end of the closure element is tied through the knot after the closure element is received through the eyelets.

10. The device of claim 1, wherein the anchors are disposed along a ring-shaped circumference in a first configuration.

11. The device of claim 1, wherein the driver is configured to simultaneously drive the plurality of anchors.

12. The device of claim 11, wherein the driver comprises a spring-loaded element configured to impact and impart a distally directed momentum to the anchors.

13. The device of claim 12, further comprising a trigger configured to release the spring-loaded element from a preloaded position in order to drive the plurality of anchors.

14. The device of claim 12, further comprising a handle, the trigger being disposed in handle.

15. The device of claim 1, wherein the plurality of anchors and the closure element are formed of bioabsorbable materials.

16. The device of claim 1, wherein the tensioner includes a hollow axial interior core such that the closure element runs through the tensioner via the interior core.

17. The device of claim 1, wherein the closure element extends beyond the proximal end of the tensioner.

18. The device of claim 1, wherein the anchors are disposed in a rectangular shape in a configuration.

19. A device, comprising:

a plurality of anchors, each including a flexible stem extending proximally from a distal end, the distal end tapers to a distal tip configured to pierce tissue;

at least one inelastic closure element coupled to the anchors, wherein the closure element includes a knot;

a driver configured to drive the anchors, with the closure element coupled to the anchors, into the tissue; and

a tensioner including a hollow axial interior core such that the closure element runs through the tensioner via the interior core;

wherein, as the closure element is drawn proximally through the tensioner, the tensioner moves distally into approximation with the knot and exerts a tension sufficient to urge the anchors toward each other in a cinching action to bring the anchors into a closed position to close at least one of an aperture and a distance in the tissue located between the anchors driven into the tissue, to secure, by the knot, the closed position of the anchors and to resist opposing forces exerted on the anchors that urge the anchors apart,

wherein a proximal end of the tensioner is removable from a body of the tensioner, wherein the closure element is coupled to the removable proximal end of the tensioner such that when the proximal end of the tensioner is removed from the body of the tensioner, the proximal end is a grip to at least one of pull and draw on the closure element.