Vascular access closure system

• US 20040243052A1
• Filed: 06/02/2003
• Published: 12/02/2004
• Est. Priority Date: 06/02/2003
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences Limited (Teleflex Incorporated)
• Original Assignee: Vascular Solutions Incorporated
• Inventors: Root, Howard, Kauphusman, James V., Prather, Richard
• Granted Patent: US 7,488,340 B2
• Time in Patent Office: Days
• US Class Current: 604/11
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• 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 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs

Abstract

A sealing device for sealing punctures in blood vessel walls including a flange connected to a flexible stem having an expansion portion in it. The flexible stem is adapted to be accommodated inside a delivery tube. The delivery tube further includes a hand-hold for ease of handling. The sealing device may further include a loader and a cutter. The flange and flexible stem are preferably constructed of a biodegradable material that has a tensile strength, rigidity, memory and other physical qualities similar to medical grade silicone. The resilient transverse expansion portion expands when deployed beyond the delivery tube in the tissue tract to create a frictional interface with the interior surface of the tissue tract to resist displacement of the flexible stem from a desired location in the tissue tract. The flexible stem also includes a flange at the distal end of the flexible stem to seal the puncture when the flexible stem is deployed.

Claims

1. A sealing device for percutaneously sealing a puncture in a vessel wall, the puncture being at a distal end of a tissue tract that passes through intervening tissues between the puncture in the vessel wall and a corresponding puncture through a skin, the sealing device being insertable in the tissue tract via an introducer, the sealing device comprising:

a delivery tube;

an elongate flexible stem loadable into the delivery tube and having a resilient transverse expansion portion that expands in an orientation generally transverse to a longitudinal axis of the stem when deployed distally beyond the delivery tube so as to create a frictional interface with an interior surface of the tissue tract that resists displacement of the flexible stem from a desired location in the tissue tract; and

a flange at a distal end of the flexible stem adapted to operably abut an interior of the puncture in the vessel wall to seal the puncture when the flexible stem is deployed.

2. The sealing device as claimed in claim 1, further comprising a semirigid stem having a distal end slidably engaged within the delivery tube that pushably deploys the sealing device distally beyond the introducer.

3. The sealing device as claimed in claim 1, in which the flexible stem is formed from a biodegradable material.

4. The sealing device as claimed in claim 1, in which the resilient expansion portion comprises a plurality of sigmoidal curves formed by at least a distal portion of the flexible stem.

5. The sealing device as claimed in claim 1, in which the resilient expansion portion further comprises friction enhancing ridges on at least a portion of an outer surface of the resilient expansion portion along the frictional interface.

6. The sealing device as claimed in claim 1, in which the flange is asymmetrically foldable about a distal end of the delivery tube when the sealing device is passing through the introducer.

7. The sealing device as claimed in claim 1, in which the transverse expansion portion comprises a helical form.

8. The sealing device as claimed in claim 1, in which the transverse expansion portion comprises a multi-winged form.

9. A system for percutaneously sealing a puncture in a vessel wall, the puncture being at a distal end of a tissue tract that passes through intervening tissues between the puncture in the vessel wall and a corresponding puncture through a skin, the system comprising:

a sealing device being insertable in the tissue tract, the sealing device comprising;

a delivery tube;

an elongate flexible stem having a resilient transverse expansion portion that expands in an orientation generally transverse to a longitudinal axis of the stem when deployed distally beyond the delivery tube so as to create a frictional interface with an interior surface of the tissue tract that resists displacement of the flexible stem from a desired location in the tissue tract; and

a flange at a distal end of the flexible stem adapted to operably abut an interior of the puncture in the vessel wall to seal the puncture; and

a cutter for severing the flexible stem at a desired location.

10. The system as claimed in claim 9, further comprising a semirigid stem having a distal end slidably engaged with a proximal end of the flexible stem within the delivery tube.

11. The system as claimed in claim 9, wherein the cutter is adapted for compressing the skin and the tissues intervening between the skin and the vessel wall puncture to facilitate severing the flexible stem at a desired location below a surface of the skin.

12. The system as claimed in claim 9, in which the transverse expansion portion comprises a sigmoid curve.

13. The system as claimed in claim 9, in which the transverse expansion portion comprises a helical form.

14. The system as claimed in claim 9, in which the transverse expansion portion comprises a multi-winged form.

15. A sealing device for percutaneously sealing a puncture in a vessel wall, the puncture being at the termination of a tissue tract that passes through intervening tissues between the vessel wall puncture and a corresponding puncture through the skin, the sealing device being insertable through an introducer, the sealing device comprising:

an elongate flexible stem pushable through the introducer; and

a flexible flange operably attached to a distal end of the flexible stem, the flange having a greatest dimension substantially larger than an outer dimension of the introducer, the flexible flange being asymmetrically foldable within the introducer when pushed through the introducer and being resiliently biased to return to a generally unfolded state upon deployment distally of the introducer.

16. The sealing device as claimed in claim 15, further comprising a semirigid stem, having a distal end slidably engaged within the delivery tube, the flexible stem having a proximal end axially engaged to the distal end of the semirigid stem and coaxially joined with the semirigid stem.

17. The sealing device as claimed in claim 15, further comprising a semirigid delivery tube by which the flexible stem is pushable through the introducer.

18. The sealing device as claimed in claim 15, in which the flexible stem comprises a biodegradable material.

19. The sealing device as claimed in claim 15, the flexible stem further including a resilient transverse expansion portion which expands in an orientation generally transverse to the longitudinal axis when deployed distally beyond the introducer so as to create a frictional interface with an interior surface of the tissue tract so as to resist displacement of the flexible stem from a desired location in the tissue tract.

20. The sealing device as claimed in claim 19, in which the resilient transverse expansion portion comprises a plurality of sigmoidal curves.

21. The scaling device as claimed in claim 19, in which the resilient transverse expansion portion comprises friction enhancing ridges on at least a portion of a surface of the sigmoidal curves along the frictional interface.

22. The sealing device as claimed in claim 19, in which the transverse expansion portion comprises a helical form.

23. The sealing device as claimed in claim 19, in which the transverse expansion portion comprises a multi-winged form.

24. A sealing device for percutaneously sealing a puncture in a blood vessel wall, the puncture being at the termination of a tissue tract that passes through intervening tissues between the vessel wall puncture and a corresponding puncture through the skin, the sealing device being insertable through an introducer, the sealing device comprising:

a semirigid outer delivery tube;

a flexible stem coaxially located within the delivery tube, the flexible stem having a resilient transverse expansion portion tensionable axially and compressible laterally into a generally linear state and to resiliently contract axially and resiliently expand laterally upon deployment distally beyond the delivery tube and to resiliently frictionally interface with an interior surface of the tissue tract so as to resist the displacement of the flexible stem from a desired location in the tissue tract; and

a flange at a distal end of the flexible stem that operably abuts an interior of the puncture in the vessel wall to seal the puncture when the flexible stem is deployed distally beyond the introducer.

25. The sealing device as claimed in claim 24, further comprising a semirigid stem, having distal end, slidably engaged within the introducer.

26. The sealing device as claimed in claim 24, in which the flexible stem and the flange are formed integrally from a biodegradable material.

27. The sealing device as claimed in claim 24, in which the resilient transverse expansion portion comprises a plurality of sigmoidal curves.

28. The sealing device as claimed in claim 24, in which the resilient transverse expansion portion further comprise friction enhancing ridges on at least a portion of an outer surface of the resilient transverse expansion portion along the frictional interface.

29. The sealing device as claimed in claim 24, in which the flange is asymmetrically foldable to facilitate passing the flange through the introducer.

30. The sealing device as claimed in claim 24, in which the transverse expansion portion comprises a helical form.

31. The sealing device as claimed in claim 24, in which the transverse expansion portion comprises a multi-winged form.

32. A sealing device for percutaneously sealing a puncture in a blood vessel wall, the puncture being at the termination of a tissue tract that passes through intervening tissues between the vessel wall puncture and a corresponding puncture through the skin, the sealing device being insertable through an introducer, the sealing device comprising:

a semirigid delivery tube;

a flexible stem being resiliently biased toward an undulating configuration, the undulating configuration being fully achieved when the stem is in an unrestrained state and the tendency of the stem toward an undulating configuration upon deployment beyond the introducer tending to resiliently grip the interior of the tissue tract so as to resist the displacement of the stem from a desired location in the tissue tract; and

a flange at a distal end of the flexible stem that operably abuts an interior of the puncture in the vessel wall to seal the puncture when the flexible stem is deployed distally beyond the introducer.

33. The sealing device as claimed in claim 32, further comprising a semirigid stem, having a distal end, slidably engaged within the delivery tube.

34. The sealing device as claimed in claim 32, in which the flexible stem and the flange are formed integrally from a biodegradable material.

35. The sealing device as claimed in claim 32, in which the undulating configuration comprises a plurality of sigmoidal curves.

36. The sealing device as claimed in claim 35, in which the sigmoidal curves further comprise friction enhancing ridges on at least a portion of a surface of the sigmoidal curves along a frictional interface with an interior surface of the tissue tract.

37. The sealing device as claimed in claim 32, in which the flange is asymmetrically foldable to facilitate passing the flange through the introducer.

38. The sealing device as claimed in claim 32, in which the undulating configuration comprises a helical form.

39. A sealing device for percutaneously sealing a puncture in a blood vessel wall, the puncture being at the termination of a tissue tract that passes through intervening tissues between the vessel wall puncture and a corresponding puncture through the skin, the sealing device being insertable through an introducer, the sealing device comprising:

means for delivering the sealing device through the introducer;

flexible means for resiliently, transversely expansibly gripping the interior of the tissue tract so as to resist the displacement from a desired location in the tissue tract, the flexible, resilient gripping means being passable through the delivery means; and

means for occluding the vessel wall puncture.

40. The sealing device as claimed in claim 39, the flexible resilient transverse gripping means further being resiliently biased toward an undulating configuration, the undulating configuration being full achieved when the flexible means is in an unrestrained state.

41. The sealing device as claimed in claim 39, in which the occluding means comprises a flange integrally joined to the flexible resilient transverse gripping means.

42. The sealing device as claimed in claim 39, in which the occluding means and the flexible resilient gripping means comprise a biodegradable material.

43. The sealing device as claimed in claim 39, in which the occluding means is asymmetrically foldable to facilitate passage through the introducer.

44. The sealing device as claimed in claim 39, in which the means for transversely expansibly gripping comprises a helical form.

45. The sealing device as claimed in claim 39, in which the means for transversely expansibly gripping comprises a multi-winged form.

46. A method for percutaneously sealing a puncture in a blood vessel wall, the puncture being at the termination of a tissue tract that passes through intervening tissues between the vessel wall puncture and a corresponding puncture through the skin, the method comprising the steps of:

inserting a flexible stem into a delivery tube;

in the process of inserting the flexible stem into the delivery tube, tensioning the flexible stem so that the flexible stem alters from an transversely expanded state to a generally linear state within the delivery tube;

inserting the delivery tube including the joined flexible stem into an introducer already placed in the tissue tract, the flexible stem having a flange at a distal end thereof;

pushing the delivery tube through the introducer until the distal end of the flexible stem is within a lumen of the blood vessel;

withdrawing the delivery tube;

from the introducer;

withdrawing the flexible stem until the flange is flush with the blood vessel wall; and

withdrawing the introducer from the tissue tract until the flange is flush with the blood vessel wall; and

maintaining tension on the flexible stem.

47. The method as claimed in claim 46, further comprising the step of severing the flexible stem at a desired location.

48. The method as claimed in claim 46, further comprising the step of advancing a cutter over the flexible stem to sever the flexible stem.

49. The method as claimed in claim 46, further comprising the step of engaging a loader to the introducer to facilitate the insertion of the delivery tube and the flexible stem into the introducer.

50. The method as claimed in claim 46, further comprising the step of asymmetrically folding the flange while inserting it into the introducer.

51. The method as claimed in claim 46, further comprising the step of utilizing a flexible stem made from a biodegradable material.

52. A sealing device for percutaneously sealing a puncture in a blood vessel wall, the puncture being at the termination of a tissue tract that passes through intervening tissues between the vessel wall puncture and a corresponding puncture through the skin, the sealing device comprising:

a sealing device being insertable through an introducer, the sealing device comprising;

means for delivering the sealing device through the introducer;

flexible means for resiliently, transversely, expansibly, gripping the interior of the tissue tract so as to resist the displacement from a desired location in the tissue tract, the flexible, resilient gripping means being pushable through the introducer; and

means for occluding the vessel wall puncture.

53. The sealing device as claimed in claim 52, further comprising means for severing the flexible resilient gripping means at a desired location.

54. The sealing device as claimed in claim 52, further comprising means for loading the sealing device into the introducer.

55. The sealing device as claimed in claim 53, in which the severing means further comprises means for compressing the skin and intervening tissues to facilitate severing the flexible resilient gripping means at the desired location.