VASCULAR CLOSURE DEVICE

• US 20170086804A1
• Filed: 09/27/2016
• Published: 03/30/2017
• Est. Priority Date: 09/28/2015
• Status: Active Grant

• Current Assignee: Arterica, Inc.
• Original Assignee: M-V Arterica AB
• Inventors: LARZON, Thomas, WHIRLEY, Robert G., KARLSSON, Daniel, NYMAN, Henrik, HUMPHREY, Joseph, LARZON, Cecilia
• Granted Patent: US 10,639,020 B2
• Time in Patent Office: Days
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00676 promotion of self-sealing of the puncture
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The present disclosure relates to a vascular closure device adapted for use in closing a puncture in a blood vessel after e.g. a percutaneous interventional procedure. The disclosure also relates to a method for vascular closure using such a vascular closure device.

Claims

1. A vascular closure device for closing a passage through tissue proximate to a blood vessel, the vascular closure device comprising:

an elongated housing having a proximal end and a distal end, the distal end adapted to be proximate the tissue;

a first and a second engagement member releasably arranged with the elongated housing;

a deployment member arranged with the elongated housing and adapted to deploy the first and the second engagement member at a distance from each other in engaged contact with said tissue, without engaging a wall portion of the blood vessel; and

a retraction member arranged with the elongated housing and adapted to reduce the distance between the first and the second engagement member to close said passage.

2. The vascular closure device according to claim 1, wherein the first and the second engagement member are adapted to engage with said tissue at a predetermined distance from the distal end of the vascular closure device.

3. The vascular closure device according to claim 1, wherein the first and the second engagement member are adapted to mechanically capture the tissue.

4. The vascular closure device according to claim 1, wherein the first and the second engagement member are adapted to engage with a fascia membrane of said tissue.

5. The vascular closure device according to claim 1, further comprising an anvil member adapted to provide a reference point in relation to the blood vessel, wherein the first and the second engagement member are adapted to engage with said tissue at a predetermined distance from anvil member.

6. The vascular closure device according to claim 5, wherein the anvil member is configured to provide an orientation in relation to the blood vessel.

7. The vascular closure device according to claim 5, wherein the anvil member is configured to provide a two-dimensional orientation (x-y) in relation to the blood vessel.

8. The vascular closure device according to claim 5, wherein the anvil member comprises one of a balloon, a deployable disk, a deployable positioning feature or an anchoring plate.

9. The vascular closure device according to claim 5, wherein the anvil member forms part of the elongated housing.

10. The vascular closure device according to claim 1, further comprising a suture connected to the first and the second engagement member, wherein the retraction member is adapted to retract the suture to reduce the distance between the first and the second engagement member.

11. The vascular closure device according to claim 10 wherein the suture and a corresponding further suture is individually connected to the first and the second engagement member, respectively.

12. The vascular closure device according to claim 10, wherein the suture is connected to both of the first and the second engagement member.

13. The vascular closure device according to claim 10, wherein the suture is formed of a biodegradable or bio-absorbable material.

14. The vascular closure device according to claim 1, wherein the first and the second engagement member is formed of a biodegradable or bio-absorbable material.

15. The vascular closure device according to claim 10, further comprising a locking member arranged with the elongated housing and adapted to maintain the suture in a retracted state, thereby creating a tissue lock.

16. The vascular closure device according to claim 15, wherein the locking member comprises a preloaded coil arranged to clench the suture in the retracted state.

17. The vascular closure device according to claim 15, wherein the locking member comprises a wire positioned to encircle the suture to maintain the suture in the retracted state.

18. The vascular closure device according to claim 15, wherein the locking member is formed of a biodegradable and bio-absorbable material.

19. The vascular closure device according to claim 1, wherein the first and the second engagement member comprises one of a barb, a hook, a needle, an anchor and a spear.

20. The vascular closure device according to claim 1, wherein the first and the second engagement member comprises an anchor, the anchor arranged as a flexible structure.

21. The vascular closure device according to claim 19, wherein the anchor is adapted to rotate, pivot or expand once in engaged connection with said tissue.

22. The vascular closure device according to claim 1, wherein the first and the second engagement member comprises a hypotube section having an inclined end portion.

23. The vascular closure device according to claim 1, further comprising a third and a fourth engagement member.

24. The vascular closure device according to claim 1, wherein the vascular closure device further comprises a guidewire lumen allowing the vascular closure device to be advanced over a guidewire.

25. The vascular closure device according to claim 1, wherein the deployment member comprises a spring-loaded portion adapted to project the first and the second engagement member into the tissue.

26. The vascular closure device according to claim 1, wherein the retraction member is adapted to apply a predetermined retraction force to thereby reduce the distance between the first and the second engagement member.

27. The vascular closure device according to claim 1, further comprising a tapered nosecone arranged at the distal end of the elongated housing.

28. The vascular closure device according to claim 1, further comprising a device positioning member to be aligned with a longitudinal axis of the blood vessel prior to deploying the first and the second engagement member.

40. Use of the vascular closure device according to claim 1 for closing a passage through tissue proximate to a blood vessel.

29. A method of closing a passage through tissue proximate to a blood vessel, the method comprising:

providing a vascular closure device, the vascular closure device comprising;

an elongated housing having a proximal end and a distal end;

a first and a second engagement member releasably arranged with the elongated housing;

a deployment member arranged with the elongated housing; and

a retraction member arranged with the elongated housing positioning the distal end of the vascular closure device proximate to the tissue,

deploying, using the deployment member, the first and the second engagement member from the vascular closure device to engage with said tissue at a distance from each other, without engaging a wall portion of the blood vessel, and

applying a predetermined retraction force, using the retraction member, to reduce the distance between the first and the second engagement member to close said passage.

30. The method according to claim 29, wherein the method further comprises:

arranging the first and the second engagement member to mechanically capture the tissue.

31. The method according to claim 29, wherein the first and the second engagement member are adapted to engage with a fascia membrane of said tissue at a predetermined distance from the distal end of the vascular closure device.

32. The method according to claim 29, wherein the vascular closure device further comprises an anvil member adapted to provide a reference point in relation to the blood vessel, and the method further comprises:

positioning the anvil member within the blood vessel.

33. The method according to claim 29, wherein the method further comprises:

advancing the vascular closure device over a guidewire.

34. The method according to claim 29, wherein the method further comprises:

connecting a suture to the first and the second engagement member, and

creating a tissue lock by retracting the suture using the retraction member.

35. The method according to claim 34, wherein the method further comprises:

applying a locking member at the suture to maintain the suture in a retracted state.

36. The method according to claim 29, wherein a suture is connected to the first and the second engagement member and the retraction member is adapted to retract the suture to reduce the distance between the first and the second engagement member, and the method further comprises:

applying a locking member at the suture to maintain the suture in a retracted state, thereby creating a tissue lock.

37. The method according to claim 29, wherein the vascular closure device further comprises a hemostasis member adapted to block blood flow through the passage, and the method further comprises:

positioning the hemostasis member within the blood vessel prior to deploying the first and the second engagement member.

38. The method according to claim 29, wherein the vascular closure device further comprising a device-positioning member, and the method further comprises:

aligning the device positioning member with a longitudinal axis of the blood vessel prior to deploying the first and the second engagement member.

39. The method according to claim 29, wherein the first and the second engagement member are deployed to engage with said tissue according to predetermined pattern.

41. A vascular closure device for treating a passage in a blood vessel by closing a passage through tissue proximate to a blood vessel, the vascular closure device comprising:

an elongated housing having a proximal end, a distal end, and a distal section;

a plurality of engagement members which are each adapted to be secured to tissue upon deployment into tissue;

a plurality of deployment members adapted to extend from the distal section of the elongated housing in a distal and radially outward direction, each of the deployment members being adapted to deploy at least one of the engagement members into the tissue proximate to the blood vessel such that the engagement members are secured to the tissue proximate to the blood vessel and disposed at a distance from each other in engaged contact with said tissue, without engaging a wall portion of the blood vessel;

a plurality of elongate flexible tension elements, each tension element being secured to at least one engagement member; and

a retraction member coupled in operative arrangement with the tension elements and adapted to apply axial tension to the tension elements and reduce the distance between the engagement members to a radially retracted state to close the passage in the tissue proximate to the blood vessel.

42. The vascular closure device according to claim 41, further comprising a locking member adapted to secure the tension elements relative to each other in the retracted state thereby creating a tissue lock.

43. The vascular closure device according to claim 42, wherein the locking member comprises a preloaded self-retracting coil with an interior passage which is disposed about the tension elements, which is sized to allow free movement of the tension elements with the coil in an expanded state and which has an interior surface that is adapted to clench the tension elements when in retracted state.

44. The vascular closure device according to claim 43, wherein the locking member is formed of a biodegradable and bio-absorbable material.

45. The vascular closure device according to claim 41, wherein the deployment members are adapted to deploy the engagement members with the tissue proximate to the blood vessel at a predetermined radial distance from the distal end of the vascular closure device.

46. The vascular closure device according to claim 41, wherein the engagement members are adapted to mechanically capture the tissue proximate to the blood vessel.

47. The vascular closure device according to claim 41, wherein the engagement members are adapted to rotate, pivot or expand once in engaged connection with the tissue.

48. The vascular closure device according to claim 47, wherein the engagement members each comprise a hypotube section having an inclined sharpened end portion.

49. The vascular closure device according to claim 41, wherein the engagement members are adapted to engage with a fascia membrane of said tissue.

50. The vascular closure device according to claim 41, further comprising a radially expandable anvil member adapted to extend distally from the distal end of the elongated housing into an interior volume of the blood vessel while in a constrained state, be deployed within the interior volume of the blood vessel and thereafter provide a reference point in relation to the wall portion of the blood vessel, and wherein the deployment members are adapted to engage the engagement members with the tissue proximate to the blood vessel at a predetermined distance from anvil member.

51. The vascular closure device according to claim 50, wherein the anvil member comprises one of a balloon, a deployable disk, a deployable positioning feature or an anchoring plate.

52. The vascular closure device according to claim 41, wherein the elongate flexible tension members comprise sutures secured to the engagement members, and wherein the retraction member is adapted to retract the sutures toward a common position adjacent a surface of the tissue proximate the blood vessel in order to reduce the distance between the engagement members and associated tissue respectively engaged therewith.

53. The vascular closure device according to claim 52, wherein the sutures are formed of a biodegradable or bio-absorbable material.

54. The vascular closure device according to claim 41, wherein the engagement members are formed of a biodegradable or bio-absorbable material.

55. The vascular closure device according to claim 41, wherein the elongated housing further comprises a guidewire lumen allowing the vascular closure device to be advanced over a guidewire.

56. The vascular closure device according to claim 41, wherein the deployment members further comprise a spring-loaded portion adapted to project the engagement members into the tissue.

57. The vascular closure device according to claim 41, wherein the retraction member is adapted to apply a predetermined retraction force to the tension elements to thereby reduce the distance between the engagement members which have been secured to the tissue.

58. The vascular closure device according to claim 41, further comprising a tapered nosecone arranged at the distal end of the elongated housing.

59. The vascular closure device according to claim 41, further comprising a device positioning member which is adapted to be aligned by visual approximation with a longitudinal axis of the blood vessel prior to deploying the engagement member.