Tissue closure device and method

• US 9,980,708 B2
• Filed: 03/15/2013
• Issued: 05/29/2018
• Est. Priority Date: 01/20/2010
• Status: Active Grant

• Current Assignee: Micro Interventional Devices, Inc.
• Original Assignee: Micro Interventional Devices, Inc.
• Inventors: Whitman, Michael P., Datcuk, Peter
• Primary Examiner(s): DANG, ANH TIEU
• Application Number:
  US13/843,930
• Publication Number:
  US 20140039548A1
• Time in Patent Office: 1,901 Days
• Field of Search: 606139, 606142, 606151, 606153, 606213-216, 606219
• 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 17/064 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 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 2017/0437 : 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 that, when implanted in the heart, closes the wound and complies with wall motion (i.e., expands and contracts with the myocardium).

Claims

1. A device, comprising:

a plurality of anchors, each one of the plurality of anchors having a distal end tapered to a distal tip configured to pierce tissue and at least one wing configured to flex relative to each anchor;

a driver including a plurality of pins, each pin in contact with a shoulder of a respective one of the plurality of anchors, configured to exert a driving force on the plurality of anchors, via the pins, to simultaneously drive the plurality of anchors into the tissue; and

at least one closure element coupled to the plurality of anchors and configured to receive the driving force, to enter a deformed state based on the driving force, and to urge the plurality of anchors toward each other by an elastic tension between the plurality of anchors during the deformed state of the at least one closure element;

wherein the at least one closure element is configured to comply with a myocardium of a beating heart without interfering with the movement of the walls of the heart, and transfer sufficient force to urge the plurality of anchors, driven into the tissue, toward each other to close an aperture in the tissue located between the plurality of anchors driven into the tissue.

2. The device of claim 1,

wherein the pins are configured to drive the plurality of anchors distally beyond a surface of the tissue;

and wherein the plurality of anchor are configured to engage with the tissue and resist proximal movement.

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

4. The device of claim 1, wherein each one of the plurality of anchors includes the at least one wing extending proximally and radially from a proximal end of the distal tip to a free end.

5. The device of claim 4, wherein the at least one wing of each one of the plurality of anchors is configured to resist proximal movement of the respective one of the plurality of anchors after the respective one of the plurality of anchors is driven into the tissue.

6. The device of claim 1, wherein each of the plurality of anchors comprises a coupling element configured to maintain engagement between the at least one closure element and the respective one of the plurality of anchors.

7. A surgical device, comprising:

a plurality of anchors, each anchor having a distal end tapered to a distal tip configured to pierce tissue, a proximal end configured to receive at least one closure element, and at least one wing extending proximally and radially outwardly from the distal end to a free end from the distal end at a shoulder of each anchor, wherein the at least one wing is configured to flex relative to each respective anchor in compliance with movement of living tissue; and

a driver including a plurality of pins, each pin in contact with the shoulder of each respective anchor, configured to exert a driving force on the plurality of anchors, via the pins, to simultaneously drive the plurality of anchors distally into the tissue;

wherein the at least one closure element is configured to receive the driving force, to enter a deformed state based on the driving force, and to urge at least two of the plurality of anchors toward each other by an elastic tension between the at least two of the plurality of anchors during the deformed state of the at least one closure element.

8. The surgical device of claim 7, wherein each pin is configured to drive each anchor distally beyond a surface of the tissue;

and wherein each anchor is configured to engage with the tissue and resist proximal movement.

9. The surgical device of claim 8, wherein the at least one wing extends proximally beyond the shoulder of each respective anchor.

10. The surgical device of claim 8, wherein each pin is configured to retract from the shoulder of each respective anchor after each anchor is driven into the tissue.

11. The surgical device of claim 7, wherein each anchor is disposed in a configuration with the plurality of anchors, and further wherein the driver is configured to simultaneously drive the plurality of anchors.

12. The surgical device of claim 11, wherein each anchor is disposed in a configuration with the plurality of anchors along a ring-shaped circumference.

13. The surgical device of claim 7, wherein the driver is configured to drive each anchor a predefined distance.

14. The surgical device of claim 7, wherein the driver comprises a spring-loaded element configured to impact and impart a distally directed momentum to each anchor.

15. The surgical device of claim 7, wherein the proximal end of each anchor is a reduced-diameter portion.

16. The surgical device of claim 7, wherein the proximal end of each anchor is a hook.

17. A surgical device, comprising

a plurality of surgical anchors, each one of the plurality of surgical anchors having a distal end tapered to a distal tip configured to pierce tissue, at least one wing extending proximally and radially outwardly from the distal end to a free end, and a proximal end configured to receive at least one closure element;

and

a delivery mechanism configured to house the plurality of surgical anchors, eject the plurality of surgical anchors, and simultaneously drive the plurality of surgical anchors into the tissue, the delivery mechanism having a plurality of pins in contact with a respective one of the plurality of surgical anchors, configured to exert a driving force on the plurality of surgical anchors to simultaneously drive the plurality of surgical anchors distally into the tissue;

wherein the at least one closure element is configured to receive the driving force, to enter a deformed state based on the driving force, and to urge at least two of the plurality of surgical anchors toward each other by an elastic tension between the at least two of the plurality of anchors during the deformed state of the at least one closure element;

wherein the at least one wing is in a relaxed position prior to ejection of the respective one of the plurality of surgical anchors from the delivery mechanism, and is configured to be compressed when driven into the tissue from a relaxed position to a compressed position; and

wherein the at least one wing is configured to return to the relaxed position after being driven into the tissue to resist proximal movement.