System and method for closure of an internal opening in tissue, such as a trans-apical access opening

• US 8,734,484 B2
• Filed: 04/21/2009
• Issued: 05/27/2014
• Est. Priority Date: 04/21/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ahlberg, Sarah, Simma, Sara, Rothstein, Paul T., Clements, Martin, Jelich, Damian, Laske, Timothy G., Clague, Cynthia, Green, Michael, Iaizzo, Paul
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US12/427,395
• Publication Number:
  US 20100268253A1
• Time in Patent Office: 1,862 Days
• Field of Search: 606/139, 606/142, 606/216, 606/217, 606/219, 606/232, 606/151, 606/157, 623/2.11, 623/2.36, 623/2.41, 623/904, 604/500
• US Class Current: 606/216
• 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 17/068 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 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0645 being elastically deformed for insertion
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/1142 Purse-string sutures
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A method for closing an opening at a target site including bodily tissue including embedding a plurality of self-closing clips into the target site in a spaced apart manner about a perimeter of the opening. Each of the clips has opposing clip ends and an intermediate segment. A flexible tether is coupled to the embedded clips to form a loop about the opening perimeter. A pulling force is applied onto at least one of the loop ends, thereby drawing the perimeter of the opening onto itself to completely close the opening. The loop ends are secured to maintain the target site in a closed state. In some embodiments, the target site is apical cardiac tissue, and the method is performed as part of a trans-apical access procedure.

Claims

1. A method for closing an opening at a target site including bodily tissue, the method comprising:

embedding a plurality of clips into the target site in a spaced apart manner about a perimeter of the opening, each clip being U-shaped and having two substantially straight parallel legs connected by an intermediate section extending between the legs, the legs and the intermediate section defining a first plane, and a substantially rigid coupling body which is configured to slidably capture a flexible tether and is assembled to and extends radially inward from the first plane of the legs and the intermediate section, at least one coupling body comprising a first portion through which the tether is slidably captured and a second portion shaped differently than the first portion and thereby configured to optionally attach a distal end of the tether or slidingly capture the tether, each leg having a pointed tip such that upon release from a delivery tool, each leg is embedded into the bodily tissue by self-transitioning from substantially straight to curved, during which self-transitioning each of the two ends legs forms an overlapping loop around an axis which remains parallel to a second plane containing the perimeter, the legs maintaining an essentially constant distance between each other; and

in the natural state, each pointed tip is directed radially outward while lying below and being generally parallel to the second plane containing the perimeter;

coupling the flexible tether to the coupling body of each of the embedded clips along an axis of the coupling body which is displaced radially inwardly from the first plane of each clip to form a loop about an entirety of the perimeter of the opening, the loop terminating at opposing loop ends;

applying a pulling force onto at least one of the opposing loop ends;

wherein the pulling force along the radially inwardly displaced axis of the coupling body is transposed onto the embedded clips to draw the perimeter of the opening onto itself to completely close the opening in transitioning the target site from an open state to a closed state; and

securing the opposing loop ends to maintain the target site in the closed state.

2. The method of claim 1, wherein the target site is apical cardiac tissue.

3. The method of claim 2, wherein the method is performed as part of a trans-apical access procedure.

4. The method of claim 3, wherein the method further includes:

inserting a surgical tool through the opening prior to the step of transitioning the target site to a closed state.

5. The method of claim 4, wherein inserting a surgical tool includes:

delivering a catheter through the opening;

deploying a prosthetic heart valve through the catheter;

implanting the prosthetic heart valve to a native annulus; and

withdrawing the catheter from the opening.

6. The method of claim 2, wherein embedding the plurality of clips includes:

driving the clips into an epicardial surface of the apical cardiac tissue.

7. The method of claim 1, further comprising:

deploying and withdrawing a surgical tool through the opening prior to the step of completely closing the opening.

8. The method of claim 1, wherein driving the clips includes:

retaining the clips in a deflected state within the delivery tool; and

releasing the clips from the delivery tool at the target site.

9. The method of claim 1, wherein an outer diameter of the second portion is less than a diameter of a passage of the first portion through which the tether is slidably retained, such that the tether extends about the second portion.

10. The method of claim 1, wherein the flexible tether is coupled to the clips prior to the step of embedding the plurality of clips at the target site.

11. The method of claim 10, further comprising:

loading the plurality of clips and the coupled flexible tether into a catheter-based delivery tool prior to embedding the plurality of clips into the target site.

12. The method of claim 11, wherein embedding the plurality of clips includes:

delivering a distal end of the catheter-based delivery tool on a minimally invasive basis to the target site.

13. The method of claim 12, wherein following the step of embedding the plurality of clips, at least one end of the flexible tether is accessible at a proximal end of the catheter-based delivery tool.

14. The method of claim 1, wherein the step of embedding the plurality of clips includes substantially simultaneously deploying the plurality of clips from the delivery tool.

15. The method of claim 1, wherein the target site includes a native heart valve annulus, and the opening is between the native annulus and an implanted prosthetic heart valve.

16. The method of claim 15, wherein embedding the plurality of clips includes:

securing at least some of the clips to tissue of the native annulus; and

securing at least some of the clips to a structure of the implanted prosthetic valve.

17. The method of claim 16, further comprising:

percutaneously implanting the prosthetic heart valve to the native annulus.

18. The method of claim 1, wherein the method is performed as part of a natural orifice transluminal endoscopic surgery.