Access and closure device and method

• US 20060271078A1
• Filed: 05/12/2006
• Published: 11/30/2006
• Est. Priority Date: 05/12/2005
• Status: Active Grant

• Current Assignee: Arstasis, Inc.
• Original Assignee: Arstasis, Inc.
• Inventors: Modesitt, D. Bruce
• Granted Patent: US 8,241,325 B2
• Time in Patent Office: Days
• US Class Current: 606/167
• 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 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00676 promotion of self-sealing of the puncture
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 25/065 Guide needles

Abstract

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make both steeply sloping and flat access paths into a vascular lumen is disclosed. The device can also form arteriotomies with sections cleaved between a vessel'"'"'s intima and adventitia. Methods for using the device are also disclosed.

Claims

1. A method for accessing a biological lumen having a lumen wall and surrounding tissue, the method comprising:

forming a path between the lumen wall and the surrounding tissue;

extending the path through the lumen wall; and

opening the path to the lumen.

2. The method of claim 1, wherein forming the path comprises inserting a device between the lumen wall and the surrounding tissue.

3. The method of claim 2, wherein extending the path comprises inserting the device through the lumen wall.

4. The method of claim 3, wherein opening the path comprises inserting the device into the lumen.

5. The method of claim 4, further comprising delivering a filler into the path.

6. The method of claim 1, further comprising filling the path.

7. The method of claim 6, wherein filling the path comprises delivering a filler into the path.

8. The method of claim 7, wherein the filler comprises a solid-setting liquid.

9. The method of claim 8, wherein the filler comprises an epoxy.

10. The method of claim 1, further comprising applying pressure to the path

11. The method of claim 10, Wherein applying the pressure comprises delivering filler adjacent to the path.

12. The method of claim 11, wherein delivering filler comprises delivering filler between the lumen wall and the surrounding tissue.

13. The method of claim 11, wherein delivering filler comprises delivering filler in the lumen wall.

14. The method of claim 11, wherein delivering filler comprises delivering filler in the surrounding tissue.

15. A method for forming an arteriotomy in a lumen having a lumen wall and surrounding tissue, the method comprising:

translating a device substantially between the lumen wall and the surrounding tissue;

turning the device toward the lumen;

translating the device through the lumen wall; and

removing the device from the lumen wall.

16. The method of claim 15, wherein the surrounding tissue comprises adventitia.

17. The method of claim 15, wherein turning comprises relaxation of a pre-formed configuration in the device.

18. The method of claim 15, further comprising translating a guide through the device.

19. The method of claim 18, wherein translating a guide comprises translating the guide into the lumen.

20. The method of claim 15, further comprising translating a guide into the lumen.

21. The method of claim 20, wherein translating a guide comprises translating the guide through the device.

22. An access device for accessing a biological lumen comprising:

an introduction device having a relaxed configuration comprising a first flat section, a first bend at an end of the first flat section, and a first slope extending at a first end from the first bend, the wherein the introduction device is configured to be translated with respect to the access device.

23. The device of claim 22, wherein the relaxed configuration of the introduction device further comprises a second bend at a second end of the first slope, a second flat section extending at a first end from the second bend, a third bend at a second end of the second flat section, and a second slope extending from the third bend.

24. The device of claim 23, further comprising a delivery guide, wherein the delivery guide is configured to deliver the introduction device.

25. The device of claim 24, further comprising an anchor, wherein the anchor extends from the delivery guide, and wherein the anchor is configured to stabilize the access device with respect to the lumen.