Compressible, deformable, or deflectable tissue closure devices and method of manufacture

• US 8,992,567 B1
• Filed: 09/21/2009
• Issued: 03/31/2015
• Est. Priority Date: 04/24/2001
• Status: Active Grant

• Current Assignee: CardioVascular Technologies, Inc.
• Original Assignee: CardioVascular Technologies, Inc.
• Inventors: Houser, Russell A.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US12/563,297
• Time in Patent Office: 2,017 Days
• Field of Search: 606/95, 606/108, 606/109, 606/213, 604/174, 604/175, 604/907
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/08 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 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00628 T-shaped occluders

Abstract

A vascular closure system includes a swellable or bioabsorbable sealing element and a plunger advancement tool. The sealing element and plunger advancement tool is configured to be inserted into the inside of a tubular medical device (such as a vascular introducer sheath, catheter, cannula, trocar, electrode wire, etc.) with the sealing element being advanced distally past the end of the tubular medical device to a desired area within the body (near or at least partially within an arteriotomy, for example) by the plunger. Once in contact with blood (or other fluid) the sealing element may swell, sealing the puncture site. The system may include one of several different features designed to assist the physician to position the sealing element in the desired location. Additional versions of the system described herein can be used for cardiovascular applications where hemostasis (temporary or permanent) is desired. Additionally, the system can be used with simple modifications for any vessel, area on, in or near any vessel, tissue area, tubular structure, duct, organ, hollow body cavity, chamber, tissue wall, or any other structures or tissues, where temporary or permanent sealing, plugging, reduction of flow, reduction of an open space, stabilization or reinforcement is needed. The system is adaptable for use in cardiovascular, gastrointestinal, neurological, reproductive, lymphatic, respiratory, and orthopedic procedures.

Claims

1. A tissue closure device for delivery into an opening in a blood vessel wall using a plunger and a medical device, the tissue closure device consisting of:

a proximal end configured to coupled with a distal end of the plunger during advancement of the tissue closure device;

a distal end;

an elongate non-tapered surface with a solid core between the proximal end and the distal end;

a first radially extending element extending radially outward from the surface positioned at the distal end of the tissue closure device, the first radially extending element comprising a proximal surface; and

a second radially extending element extending radially outward from the surface positioned between the distal end and the proximal end of the tissue closure device, the second radially extending element comprising a distal surface;

wherein the first and second radially extending elements are at least partially compressible, deformable or deflectable to have a first configuration when positioned within the medical device and a second configuration when advanced beyond a distal end of the medical device,

wherein the proximal surface of the first radially extending element is adapted to contact and conform to an inner surface of the blood vessel wall near the blood vessel wall opening when the radially extending element is in the second configuration, and

wherein the distal surface of the second radially extending element is adapted to contact and conform to an outer surface of the blood vessel wall near the blood vessel wall opening when the radially extending element is in the second configuration,

wherein the tissue closure device is formed from a single piece.

2. The tissue closure device of claim 1 wherein the elongate non-tapered surface with the solid core has a cross-sectional geometry selected from the group comprising round, oval, elliptical, triangular, rectangular, square, ridged, x-shaped, star-shaped, cross-shaped, and combinations thereof.

3. The tissue closure device of claim 1, wherein the medical device is selected from the group comprising at least one of an introducer, a needle, a catheter, an endoscope, a trocar, a cannula, and an electrode wire.

4. The tissue closure device of claim 1, wherein the closure device is deliverable through an introducer sheath.

5. The tissue closure device of claim 1, wherein the closure device has a first diameter along a first portion of its length and at least a second diameter along a second portion of its length.

6. The tissue closure device of claim 1, wherein at least one of the proximal end or the distal end is flared.

7. The tissue closure device of claim 1, wherein the first radially extending element extends further from the surface than the second radially extending element.

8. The tissue closure device of claim 1, wherein the portion of the tissue closure device between the proximal end and the distal end is solid.

9. The tissue closure device of claim 1, wherein the tissue closure device has an hourglass shape.

10. The tissue closure device of claim 9, wherein the hourglass shape is adapted to seat the tissue closure device within the tissue opening.

11. The tissue closure device of claim 10, wherein the tissue closure device has a small diameter section bordered by two larger diameter sections and further wherein a distance is provided longitudinally between a first larger diameter section and a second larger diameter section.

12. The tissue closure device of claim 1, wherein the tissue closure device has a cross-sectional geometry selected from the group comprising:

oval, elliptical, rectangular, square, ridged, triangle, x-shaped, star-shaped, cross-shaped, and combinations thereof.

13. The tissue closure device of claim 1, wherein the tissue closure device is made from a material that is at least one of biocompatable, bioabsorbable, swellable, and biodegradable.

14. The tissue closure device of claim 13, wherein the material is one or more material selected from the group comprising:

collagen, cellulose, hydrogels, polyglycolide, polyglycolic acid, polylactic acid, starch, polymer, polyethylene polymer, lactide, and caprolactone.

15. The tissue closure device of claim 13, wherein the material is swellable in the presence of fluid.

16. The tissue closure device of claim 15, wherein the fluid is selected from the group comprising blood, saline and subcutaneous fluid.

17. The tissue closure device of claim 1, wherein the tissue closure device is made from one or more materials that are bioabsorbable.

18. The tissue closure device of claim 1, wherein the tissue closure device is removable from the blood vessel wall opening.

19. The tissue closure device of claim 1, wherein the tissue closure device is manufactured in part from a radiopaque material.

20. The tissue closure device of claim 1, wherein the tissue closure device is configured to include a tissue engagement area.

21. The tissue closure device of claim 1, wherein the tissue closure device is adapted to deliver a therapeutic or an adhesive agent to at or near the tissue opening.

22. The tissue closure device of claim 1, wherein the tissue closure device is adapted to temporarily or permanently cinch, anchor, close, compress, seal, stabilize, reduce an open space for tissue or reinforce tissue.

23. The tissue closure device of claim 1, wherein the tissue closure device is configured to be used with the medical device.

24. The tissue closure device of claim 23, wherein the medical device is selected from the group comprising at least one of an introducer, a needle, a catheter, an endoscope, a trocar, a cannula, and an electrode wire.

25. The tissue closure device of claim 1 wherein the first radially extending element and the second radially extending element are deflected proximately when positioned within the medical device, and are expanded when advanced beyond the distal end of the medical device.

26. The tissue closure device of claim 25, wherein the first radially extending element and the second radially extending element are configured to contact and conform to a tissue surface when in the expanded state.

27. The tissue closure device of claim 26 wherein the tissue surface is an artery.

28. The tissue closure device of claim 1 wherein the surface with the solid core does not extend distally past the first radially extending element positioned at the distal end of the tissue closure device.

29. The tissue closure device of claim 28 wherein the second radially extending element is a continuous piece.

30. The tissue closure device of claim 1 wherein first radially extending element positioned at the distal end has a different geometry than the second radially extending element between the distal end and the proximal end.

31. The tissue closure device of claim 1 wherein the tissue closure device is removable from the tissue opening.