Vessel access and closure device

• US 10,149,677 B2
• Filed: 06/06/2015
• Issued: 12/11/2018
• 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 Charles, Johnson, Eric T., Safa, Bauback
• Primary Examiner(s): RODJOM, KATHERINE MARIE
• Application Number:
  US14/732,719
• Publication Number:
  US 20150265272A1
• Time in Patent Office: 1,284 Days
• 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

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 The device is withdrawn and replaced with a vessel dilator and an introducer sheath that opens up a larger access opening into the blood vessel and creates a pathway that passes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 After the interventional procedure is completed, the interventional device and the introducer sheath are withdrawn and the running suture is tightened and secured with a suture lock to close the access opening into the vessel.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 blood vessel access and closure device, comprising:

a helical suture needle having a proximal end and a distal end;

a torque transmitting member having a proximal end and a distal end, the distal end of the torque transmitting member being attached to the proximal end of the helical suture needle;

a suture having a proximal end and a distal end, the distal end of the suture being releasably attached near the distal end of the helical suture needle;

a suture anchor attached to the distal end of the helical suture;

a vessel dilator having a proximal end and a distal end, the vessel dilator having a tapered distal portion connected to a cylindrical body; and

a cutting element located on the tapered distal portion of the vessel dilator.

2. The blood vessel access and closure device of claim 1, wherein the torque transmitting member is a torque tube having a central lumen extending therethrough.

3. The blood vessel access and closure device of claim 1, further comprising:

an outer tube surrounding the torque transmitting member.

4. The blood vessel access and closure device of claim 3, further comprising:

a suturing tip connected to a distal end of the outer tube, the suturing tip being configured to redirect the helical suture needle from an orientation aligned with a longitudinal axis of the outer tube to an orientation aligned with a second axis that is at an angle with respect to the longitudinal axis of the outer tube.

5. The blood vessel access and closure device of claim 4, further comprising:

a needle guide located within the outer tube proximal to the suturing tip, the needle guide having a helical groove configured to engage the helical suture needle.

6. The blood vessel access and closure device of claim 3, further comprising:

a stationary handle attached to a proximal end of the outer tube; and

a rotatable handle attached to a proximal end of the torque transmitting member.

7. The blood vessel access and closure device of claim 6, wherein the stationary handle and the rotatable handle are configured to limit axial movement of the torque transmitting member with respect to the outer tube.

8. The blood vessel access and closure device of claim 1, further comprising:

an introducer sheath having a sheath lumen that is positioned around the cylindrical body of the vessel dilator.

9. The blood vessel access and closure device of claim 1, further comprising:

a scoring element located on the tapered distal portion of the vessel dilator.

10. The blood vessel access and closure device of claim 1, wherein the helical suture needle is tubular with a needle lumen extending therethrough, and the suture extends through the needle lumen.

11. The blood vessel access and closure device of claim 1, wherein the helical suture needle has a suture channel extending along an exterior of the helical suture needle, and the suture extends through the suture channel.

12. The blood vessel access and closure device of claim 1, wherein the distal end of the suture is releasably attached near the distal end of the helical suture needle by the suture anchor.

13. The blood vessel access and closure device of claim 1, wherein the suture anchor has at least one barb for attaching the suture anchor to a wall of a blood vessel.

14. The blood vessel access and closure device of claim 1, wherein the suture anchor has a retracted position and an expanded position, wherein, in the expanded position, the suture anchor is configured for attaching the suture anchor to a wall of a blood vessel.

15. The blood vessel access and closure device of claim 1, wherein the suture anchor is releasably attached to the distal end of the helical suture needle, and the suture anchor has a sharpened distal tip for penetrating a wall of a blood vessel.

16. The blood vessel access and closure device of claim 1, wherein the distal end of the helical suture needle has a sharpened distal tip for penetrating a wall of a blood vessel.

17. The blood vessel access and closure device of claim 1, further comprising:

a positioning device having an elongated guiding member and an eccentrically expandable biasing member mounted near a distal end of the elongated guiding member.

18. The blood vessel access and closure device of claim 17, wherein the eccentrically expandable biasing member is an inflatable balloon mounted on one side of the elongated guiding member.

19. The blood vessel access and closure device of claim 17, wherein the eccentrically expandable biasing member comprises a spacer arm that is biased to move away from the elongated guiding member.

20. The blood vessel access and closure device of claim 1, further comprising:

a hemostasis valve configured to allow insertion of a guidewire through the blood vessel access and closure device while controlling bleeding through the blood vessel access and closure device.

21. The blood vessel access and closure device of claim 1, further comprising:

a guiding element having a D-shaped cross section configured to guide the helical suture needle on a path through a wall of a blood vessel.

22. A blood vessel access and closure device, comprising:

a helical suture needle having a proximal end and a distal end;

a torque transmitting tube having a proximal end and a distal end, the distal end of the torque transmitting tube being attached to the proximal end of the helical suture needle;

an outer tube surrounding the torque transmitting tube;

a stationary handle attached to a proximal end of the outer tube;

a rotatable handle attached to a proximal end of the torque transmitting member, wherein the stationary handle and the rotatable handle are configured to limit axial movement of the torque transmitting tube with respect to the outer tube;

a suturing tip connected to a distal end of the outer tube, the suturing tip being configured to redirect the helical suture needle from an orientation aligned with a longitudinal axis of the outer tube to an orientation aligned with an axis that is at an angle with respect to the longitudinal axis of the outer tube;

a needle guide located within the outer tube proximal to the suturing tip, the needle guide having a helical groove configured to engage the helical suture needle;

a suture having a proximal end and a distal end;

a suture anchor attached to the distal end of the helical suture, the suture anchor being releasably attached near the distal end of the helical suture needle;

a vessel dilator having a proximal end and a distal end, the vessel dilator having a tapered distal portion connected to a cylindrical body;

a cutting or scoring element located on the tapered distal portion of the vessel dilator; and

an introducer sheath having a sheath lumen that is positioned around the cylindrical body of the vessel dilator.

23. A system for blood vessel access and closure, comprising:

an access needle having a needle lumen extending therethrough;

a guidewire insertable through the needle lumen of the access needle, the guidewire having a distal portion and a proximal portion with a bend between the distal portion and the proximal portion;

a blood vessel access and closure device, comprising;

a helical suture needle having a proximal end and a distal end;

a torque transmitting member having a proximal end and a distal end, the distal end of the torque transmitting member being attached to the proximal end of the helical suture needle;

a suture having a proximal end and a distal end, the distal end of the suture being releasably attached near the distal end of the helical suture needle;

a suture anchor attached to the distal end of the helical suture;

a vessel dilator having a proximal end and a distal end, the vessel dilator having a tapered distal portion connected to a cylindrical body;

a cutting element located on the tapered distal portion of the vessel dilator; and

an introducer sheath having a sheath lumen that is positioned around the cylindrical body of the vessel dilator.

24. The system of claim 23, wherein the torque transmitting member is a torque tube having a central lumen extending therethrough.

25. The system of claim 23, further comprising:

an outer tube surrounding the torque transmitting member.

26. The system of claim 25, further comprising:

a suturing tip connected to a distal end of the outer tube, the suturing tip being configured to redirect the helical suture needle from an orientation aligned with a longitudinal axis of the outer tube to an orientation aligned with a second axis that is at an angle with respect to the longitudinal axis of the outer tube.

27. The system of claim 26, further comprising:

a needle guide located within the outer tube proximal to the suturing tip, the needle guide having a helical groove configured to engage the helical suture needle.

28. The system of claim 23, further comprising:

a scoring element located on the tapered distal portion of the vessel dilator.

29. The system of claim 25, further comprising:

a stationary handle attached to a proximal end of the outer tube; and

a rotatable handle attached to a proximal end of the torque transmitting member.

30. The system of claim 23, wherein the helical suture needle is tubular with a needle lumen extending therethrough, and the suture extends through the needle lumen.

31. The system of claim 23, wherein the helical suture needle has a suture channel extending along an exterior of the helical suture needle, and the suture extends through the suture channel.

32. The system of claim 23, wherein the distal end of the suture is releasably attached near the distal end of the helical suture needle by the suture anchor.

33. The system of claim 23, wherein the suture anchor has at least one barb for attaching the suture anchor to a wall of a blood vessel.

34. The system of claim 23, wherein the suture anchor has a retracted position and an expanded position, wherein, in the expanded position, the suture anchor is configured for attaching the suture anchor to a wall of a blood vessel.

35. The system of claim 23, wherein the suture anchor is releasably attached to the distal end of the helical suture needle, and the suture anchor has a sharpened distal tip for penetrating a wall of a blood vessel.

36. The system of claim 23, wherein the distal end of the helical suture needle has a sharpened distal tip for penetrating a wall of a blood vessel.

37. The system of claim 23, further comprising:

a positioning device having an elongated guiding member and an eccentrically expandable biasing member mounted near a distal end of the elongated guiding member.

38. The system of claim 37, wherein the eccentrically expandable biasing member is an inflatable balloon mounted on one side of the elongated guiding member.

39. The system of claim 37, wherein the eccentrically expandable biasing member comprises a spacer arm that is biased to move away from the elongated guiding member.

40. The system of claim 23, further comprising:

a hemostasis valve configured to allow insertion of the guidewire through the blood vessel access and closure device while controlling bleeding through the blood vessel access and closure device.

41. The system of claim 23, further comprising:

a guiding element having a D-shaped cross section configured to guide the helical suture needle on a path through a wall of a blood vessel.