Access and closure device and method

• US 8,241,325 B2
• Filed: 05/12/2006
• Issued: 08/14/2012
• Est. Priority Date: 05/12/2005
• Status: Expired due to Fees

• Current Assignee: Arstasis, Inc.
• Original Assignee: Arstasis, Inc.
• Inventors: Modesitt, D. Bruce
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US11/432,982
• Publication Number:
  US 20060271078A1
• Time in Patent Office: 2,286 Days
• Field of Search: 606/167, 606/213, 606/215, 606/216, 606/221, 604/164.01, 604/11, 604/158, 604/115
• US Class Current: 606/215
• 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 lumen of a vessel, the lumen defined by a vessel wall, the method comprising:

a. advancing a first elongate member across the vessel wall to a deployed configuration wherein at least a portion of the first elongate member occupies the lumen, the first elongate member creating a first pathway through the vessel wall;

b. using the deployed configuration of the first elongate member to mechanically enforce an introduction angle for advancing a second elongate member across at least a portion of the vessel wall;

c. advancing the second elongate member across the vessel wall to a position wherein a second pathway is created through the vessel wall to the lumen; and

d. delivering a filler into the second pathway, wherein the filler comprises a solid setting liquid.

2. The method of claim 1, wherein advancing the first elongate member comprises inserting an introduction device between an outer surface of the vessel wall and tissue surrounding the outer surface of the vessel wall.

3. The method of claim 2, wherein the tissue surrounding the outer surface of the vessel wall comprises adventitia.

4. The method of claim 1, wherein the first elongate member comprises an anchor, and wherein using the deployed configuration to mechanically enforce an introduction angle comprises using the anchor to stabilize the second elongate member with respect to the lumen.

5. The method of claim 4, wherein the second elongate member is advanced through the vessel wall while the anchor stabilizes the second elongate member with respect to the lumen.

6. The method of claim 1, wherein the second pathway is a self-sealing pathway.

7. The method of claim 1, wherein the filler comprises an epoxy.

8. The method of claim 1, further comprising advancing a third elongate member through the second elongate member.

9. A method for accessing a lumen of a vessel, the lumen defined by a vessel wall, the method comprising:

a. advancing a first elongate member across the vessel wall to a deployed configuration wherein at least a portion of the first elongate member occupies the lumen, the first elongate member creating a first pathway through the vessel wall;

b. using the deployed configuration of the first elongate member to mechanically enforce an introduction angle for advancing a second elongate member across at least a portion of the vessel wall;

c. advancing the second elongate member across the vessel wall to a position wherein a second pathway is created through the vessel wall to the lumen; and

d. applying pressure to the second pathway by delivering a filler adjacent to the second pathway.

10. The method of claim 9, wherein delivering filler comprises delivering filler into a portion of the second pathway located between an outer surface of the vessel wall and tissue surrounding the outer surface of the vessel wall.

11. The method of claim 9, wherein delivering filler comprises delivering filler in the vessel wall.

12. The method of claim 9, wherein delivering filler comprises delivering filler into tissue surrounding an outer surface of the vessel wall.

13. The method of claim 9, further comprising advancing a third elongate member through the second elongate member.

14. The method of claim 9, wherein the filler comprises a solid setting liquid.

15. The method of claim 14, wherein the filler comprises an epoxy.