SYSTEM AND METHOD FOR CLOSURE OF AN INTERNAL OPENING IN TISSUE, SUCH AS A TRANS-APICAL ACCESS OPENING

• US 20100268253A1
• Filed: 04/21/2009
• Published: 10/21/2010
• Est. Priority Date: 04/21/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Green, Michael, Ahlberg, Sarah, Simma, Sara, Iaizzo, Paul, Clague, Cynthia, Clements, Martin, Rothstein, Paul T., Laske, Timothy G., Jelich, Damian
• Granted Patent: US 8,734,484 B2
• Time in Patent Office: Days
• US Class Current: 606/142
• 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
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• 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, the plurality of self-closing clips each having opposing clip ends and an intermediate segment extending between the clip ends;

coupling a flexible tether to the intermediate section of each of the embedded clips 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 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 3, wherein the steps of embedding the clips and coupling the flexible tether further include:

a) deploying the clips to the target site prior to forming the opening;

b) coupling the flexible tether to the clips prior to forming the opening;

c) forming the opening through a thickness of the target site tissue, the opening being within a region bounded by the loop;

wherein the step of completely closing the opening is performed after the step of forming the opening.

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

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

9. The method of claim 8, wherein at least one of the ends of each of the clips forms a piercing body, and further wherein driving the clips includes:

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

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

wherein the clips self-transition from the deflected state toward a natural state upon release from the delivery tool to force the piercing body into the epicardial surface.

10. The method of claim 9, wherein both ends of each of the clips forms a piercing body such that upon release from the delivery tool, both of the piercing bodies are forced into the epicardial surface with self-transitioning of the corresponding clip from the deflected state.

11. The method of claim 1, wherein each of the plurality of clips includes a clasp configured to slidably capture the flexible tether.

12. The method of claim 11, wherein the flexible tether is coupled to the clasps prior to the step of embedding the plurality of clips at the target site.

13. The method of claim 12, 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.

14. The method of claim 13, 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.

15. The method of claim 14, 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.

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

17. 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.

18. The method of claim 17, 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.

19. The method of claim 18, further comprising:

percutaneously implanting the prosthetic heart valve to the native annulus.

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

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

a plurality of clip assemblies each including;

a self-closing clip defined by opposing leg segments and an intermediate segment, each of the leg segments terminating at a piercing end,

wherein each of the clips are self-transitionable from a deflected state to a natural state in which the leg segments are curved in extension from the intermediate segment and the intermediate segment is relatively straight, the deflected state including the leg segments approaching a straightened shape,

a clasp coupled to the intermediate segment; and

a flexible tether extending between and interconnecting each of the clasps.

22. The system of claim 21, wherein the flexible tether is slidably coupled to each of the clasps.

23. The system of claim 22, wherein the flexible tether is a suture.

24. The system of claim 21, further comprising:

a delivery tool configured to maintain the clips in the deflected state and the flexible tether.

25. The system of claim 24, wherein the delivery tool is further configured to substantially simultaneously deploy the clip assemblies.

26. The system of claim 24, wherein the delivery tool is configured to maintain the clip assemblies in a circular arrangement.

27. A method for sealing a paravalvular leak defined by a cavity between an implanted prosthetic valve and a native annulus, the method comprising:

inserting a homogenous plug body into the cavity; and

deploying at least one self-closing clip into the plug body and tissue of the native annulus to secure the plug body to the tissue.

28. The method of claim 27, wherein the plug body is selected from the group consisting of a sponge, Dacron, and foam.

29. A method of delivering an endocardial lead for an implantable cardiac stimulation device, the method comprising:

embedding a plurality of clips into tissue of a bodily target site in a spaced apart manner to collectively define a clip perimeter, the plurality of self-closing clips each having opposing clip ends and an intermediate segment extending therebetween;

coupling a flexible tether to the intermediate section of each of the embedded clips to form a loop along the clip perimeter, the loop terminating at opposing loop ends;

forming an opening through the target site within the clip perimeter, the opening defined by a target site opening perimeter;

passing the lead through the opening such that a segment of the lead is disposed within the opening;

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

wherein the pulling force is transposed onto the embedded clips to draw an entirety of the target site opening perimeter into contact with the lead segment to 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.

30. The method of claim 29, wherein the target site is a jugular vein.

31. The method of claim 29, wherein the target site is a right atrium.