Vessel access and closure device

• US 9,078,633 B2
• Filed: 09/02/2011
• Issued: 07/14/2015
• Est. Priority Date: 03/14/2009
• Status: Active Grant

• Current Assignee: VasoStitch Inc (CardioLogical Solutions, Inc.)
• Original Assignee: VasoStitch Inc (CardioLogical Solutions, Inc.)
• Inventors: Belson, Amir, Faulkner, Joelle, Burke, Phillip, Johnson, Eric, Safa, Bauback
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): PAEZ, LUCAS M
• Application Number:
  US13/224,666
• Publication Number:
  US 20120143226A1
• Time in Patent Office: 1,411 Days
• Field of Search: 606/139, 606/144, 606/148, 606222-224, 606/228, 606/232
• US Class Current: 1/1
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171

Abstract

A vessel access and closure device places a running suture in the wall of a blood vessel using a rotating helical suture needle that carries the suture along a helical path passing through the vessel wall, then reverses rotation to release a suture anchor attached to the distal end of the suture. A loose helical coil of suture is left behind as the helical suture needle withdraws. The device is withdrawn and replaced with a vessel dilator and an introducer sheath that opens up a larger access opening into the blood vessel and creates a pathway that passes though the helical coil of suture for introducing an interventional device into the blood vessel. After the interventional procedure is completed, the interventional device and the introducer sheath are withdrawn and the running suture is tightened and secured with a suture lock to close the access opening into the vessel.

Claims

1. A method, comprising:

positioning a distal end of a blood vessel access and closure device against a wall of a blood vessel in a patient;

advancing a distal end of a helical suture needle from the blood vessel access and closure device along a helical path that passes through the wall of the blood vessel, the suture having a distal end releasably attached near the distal end of the helical suture needle;

retracting the distal end of the helical suture needle into the blood vessel access and closure device along the helical path, leaving the suture in a helical suture coil that passes into the wall of the blood vessel;

creating an access opening through the wall of the blood vessel within an area of the wall bounded by the helical suture coil; and

tightening the helical suture coil to close the access opening in the wall of the blood vessel.

2. The method of claim 1, further comprising:

introducing an interventional device through the access opening into a lumen of the blood vessel;

performing an interventional procedure with the interventional device; and

withdrawing the interventional device from the access opening prior to closing the access opening in the wall of the blood vessel.

3. The method of claim 1, wherein the step of leaving the helical suture coil in the wall of the blood vessel further comprises:

redirecting the helical suture needle from an orientation aligned with a longitudinal axis of the blood vessel access and closure device to an orientation aligned with a second axis that is at an angle with respect to the longitudinal axis of the blood vessel access and closure device.

4. The method of claim 1, wherein the second axis is approximately parallel to a longitudinal axis of the blood vessel.

5. The method of claim 1, wherein the step of creating an access opening through the wall of the blood vessel within the helical suture coil comprises:

passing a vessel dilator through the helical coil of suture and dilating the access opening through the wall of the blood vessel with a tapered tip of the vessel dilator.

6. The method of claim 1, wherein the step of creating an access opening through the wall of the blood vessel within the helical suture coil comprises:

passing a vessel dilator having a tapered tip with a cutting element positioned on the tapered tip through the helical coil of suture and opening the access opening through the wall of the blood vessel with the tapered tip and the cutting element of the vessel dilator.

7. The method of claim 6, wherein the opening through the wall of the blood vessel is oriented longitudinally with respect to the blood vessel.

8. The method of claim 1, wherein the step of creating an access opening through the wall of the blood vessel within the helical suture coil comprises:

passing a vessel dilator having a tapered tip with a scoring element positioned on the tapered tip through the helical coil of suture and opening the access opening through the wall of the blood vessel with the tapered tip and the scoring element of the vessel dilator.

9. The method of claim 8, wherein the opening through the wall of the blood vessel is oriented longitudinally with respect to the blood vessel.

10. The method of claim 1, further comprising:

introducing at least one device through the access opening into a lumen of the blood vessel by passing the at least one device through the helical coil of suture.

11. The method of claim 10, further comprising:

performing an interventional procedure on the patient with the at least one device.

12. The method of claim 1, further comprising:

percutaneously accessing a lumen of the blood vessel with an access needle;

passing a guidewire through a guidewire lumen in the access needle into the lumen of the blood vessel; and

withdrawing the access needle, leaving the guidewire to maintain a pathway into the lumen of the blood vessel.

13. The method of claim 12, wherein the guidewire has a distal portion and a proximal portion with a bend between the distal portion and the proximal portion, and wherein the step of positioning a distal end of a blood vessel access and closure device against a wall of a blood vessel comprises:

placing tension on the guidewire while advancing the distal end of the blood vessel access and closure device along the guidewire to affirmatively position the distal end of the blood vessel access and closure device against the wall of the blood vessel.

14. The method of claim 1, wherein the step of positioning a distal end of a blood vessel access and closure device against a wall of a blood vessel comprises:

inserting a distal end of an elongated guiding member through a puncture site in the wall of the blood vessel into a lumen of the blood vessel;

expanding a biasing member mounted near the distal end of the elongated guiding member to bias the elongated guiding member against the wall of the blood vessel; and

advancing the distal end of a blood vessel access and closure device along the elongated guiding member to contact the wall of the blood vessel.

15. The method of claim 14, wherein the step of expanding a biasing member mounted near the distal end of the elongated guiding member comprises:

inflating an inflatable balloon attached to the elongated guiding member to bias the elongated guiding member against the wall of the blood vessel.

16. The method of claim 14, wherein the step of expanding a biasing member mounted near the distal end of the elongated guiding member comprises:

spreading a spacing arm apart from the elongated guiding member to bias the elongated guiding member against the wall of the blood vessel.

17. The method of claim 1, further comprising:

inserting a distal end of an elongated guiding member through a puncture site in the wall of the blood vessel into the lumen of the blood vessel;

positioning a portion of the elongated guiding member against an interior surface of the blood vessel wall; and

rotating the helical suture needle around the elongated guiding member.

18. The method of claim 17, wherein the elongated guiding member has a D-shaped cross section and the method comprises positioning a flat surface of the D-shaped elongated guiding member against an interior surface of the blood vessel wall.

19. The method of claim 1, further comprising:

making a needle puncture through the wall of the blood vessel;

placing at least one stitch of the helical suture coil in the wall of the blood vessel proximal to the needle puncture; and

placing at least one stitch of the helical suture coil in the wall of the blood vessel distal to the needle puncture.

20. The method of claim 1, further comprising:

exciting the helical suture needle with vibrational energy while advancing the distal end of the helical suture needle through the wall of the blood vessel.

21. The method of claim 1, wherein the suture is extendable.

22. The method of claim 1, wherein the suture is stretchable.

23. The method of claim 1, wherein additional length of the suture is placed along the helical path through the wall of the blood vessel.

24. The method of claim 1, further comprising:

securing the tightened helical suture coil with a suture lock.