COLLAPSIBLE TUBE FOR HEMOSTASIS

• US 20190142402A1
• Filed: 11/14/2018
• Published: 05/16/2019
• Est. Priority Date: 11/16/2017
• Status: Active Grant

• Current Assignee: Arterica, Inc.
• Original Assignee: M-V Arterica AB
• Inventors: LARZON, Thomas, LARZON, Cecilia
• Granted Patent: US 11,179,145 B2
• Time in Patent Office: 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 17/0401 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 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• 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: 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: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

Collapsible tube embodiments may be used to promote hemostasis at surgical sites or any other suitable location. In some cases, vascular closure device embodiments may include collapsible tube embodiments in order to promote hemostasis at a surgical site during a vascular closure procedure.

Claims

1. A vascular closure device, comprising:

a housing including an elongate configuration with an axial length greater than a transverse dimension thereof, a proximal end, a distal end and a distal section;

a plurality of anchor deployers configured to extend from the distal section of the housing, each anchor deployer comprising;

a deployment rod which is slidably disposed relative to the housing and which includes an elongate resilient configuration and a distal end that extends distally and radially from the distal section of the housing,

an anchor which is removably secured to the distal end of the deployment rod and which is configured to penetrate tissue in a distal direction,

a filament which is slidably disposed within the housing and which includes a distal end which is secured to the anchor, and

a collapsible tube disposed over a distal section of the filament proximal of and adjacent to the anchor, the collapsible tube including an elongate configuration having an axial length greater than a transverse dimension thereof and a wall structure that is configured to shorten in axial length and radially expand upon axial compression; and

and wherein the filaments of the plurality of anchor deployers are slidably disposed within the housing adjacent each other at the distal section of the housing.

2. The vascular closure device of claim 1 wherein the housing further comprises a guidewire lumen extending an axial length thereof.

3. The vascular closure device of claim 1 further comprising a handle secured to the proximal end of the housing.

4. The vascular closure device of claim 1 further comprising a rod pusher operatively coupled to the deployment rod.

5. The vascular closure device of claim 1 further comprising a filament tensioner operatively coupled to the filament of each anchor deployer.

6. The vascular closure device of claim 1 wherein the collapsible tubes comprise a distal section which tapers distally to a reduced outer transverse dimension.

7. The vascular closure device of claim 1 wherein the collapsible tubes comprise a distal end which is secured to the respective filaments adjacent the anchor.

8. The vascular closure device of claim 1 wherein the collapsible tubes comprise a distal end which is secured directly to the respective anchors.

9. The vascular closure device of claim 1 wherein the collapsible tubes comprise a longitudinal slit in a middle section of a wall thereof.

10. The vascular closure device of claim 9 wherein the collapsible tubes comprise a plurality of longitudinal slits in a middle section in the wall thereof.

11. The vascular closure device of claim 1 wherein the collapsible tubes comprise a material selected from the group consisting of polyurethane, polyethylene terephthalate (PET), polyetherether keytone (PEEK), polytetrafluoroethylene (PTFE), acrylic, silicone, polypropylene, and polyester.

12. The vascular closure device of claim 1 wherein the collapsible tubes comprise a thrombogenic material.

13. The vascular closure device of claim 12 wherein the thrombogenic material comprises a material selected from the group consisting of collagen, fibrin, fibrinogen, gelatin, polylactic acid (PLA), polyglycolic acid (PGA), alginate and fibronectin.

14. The vascular closure device of claim 1 wherein the collapsible tubes comprise a hydrogel material that swells to a larger volume over time in an aqueous environment.

15. The vascular closure device of claim 14 wherein the hydrogel material comprises a material selected from the group consisting of fibrin, collagen, gelatin, hyaluronic acid, alginate, agarose, poly(ethylene glycol), poly(acrylic acid), poly(vinyl alcohol), polypeptides, and poly(vinyl pyrrolidone).

16. The vascular closure device of claim 1 wherein the collapsible tubes comprise a slit through the wall of the tube extending distally from the proximal end of the collapsible tube.

17. The vascular closure device of claim 16 wherein the collapsible tube comprises a plurality of slits through the wall extending distally from the proximal end of the collapsible tube.

18. The vascular closure device of claim 17 wherein the plurality of slits through the wall extending distally from the proximal end of the collapsible tube comprise a length of about 1 mm to about 4 mm.

19. The vascular closure device of claim 1 wherein the wall thickness of the collapsible tubes tapers to a reduced wall thickness from a position which is distal of the proximal end of the collapsible tube to a position at the proximal end of the collapsible tube.

20. The vascular closure device of claim 1 wherein the collapsible tubes flare proximally to a larger outer transverse dimension from a position which is distal of the proximal end of the collapsible tube to a position at the proximal end of the collapsible tube.

21. The vascular closure device of claim 1 wherein the collapsible tubes comprise an axial length of about 3 mm to about 15 mm.

22. The vascular closure device of claim 1 wherein the collapsible tubes comprise an outer transverse dimension of about 0.5 mm to about 2 mm.

23. The vascular closure device of claim 1 further comprising a filament grip that is disposed on the distal end of the housing adjacent the filaments and which is configured to compress and secure the filaments relative to each other once deployed from the distal end of the housing.

24. The vascular closure device of claim 23 wherein the filament grip comprises a lock ring disposed about the filaments which includes a self-retracting coil with a central lumen which is disposed about the filaments, which is sized to allow free movement of the filaments with the self-retracting coil in an expanded state and which has an interior surface of the central lumen that is configured to compress the filaments when in a retracted state.

25. The vascular closure device of claim 1 further comprising a lateral surface configured to extend radially from a distal extension of the housing while the lateral surface is disposed within a blood vessel to provide a reference point between axial relative positions of the wall of the blood vessel and the anchors prior to deployment of the anchors.

26. The vascular closure device of claim 25 wherein the anchors can be deployed a predetermined axial distance from the wall of the blood vessel as measured from the lateral surface which is disposed against the wall of the blood vessel.

27. A method of preventing blood leakage from a closure site of a passage in a tissue layer, comprising:

disposing a distal end of a housing of a vascular closure device to a position adjacent the passage in the tissue layer;

deploying a plurality of anchor deployers from a distal section of the housing in a distal and radially outward direction from the housing into the tissue layer in positions disposed about the passage in the tissue layer;

penetrating the tissue layer with the plurality of anchor deployers of the vascular closure device and extending each of the plurality of anchor deployers distally through the tissue layer until a proximal end of a collapsible tube of each of the plurality of anchor deployers extends distally beyond a lower surface of the tissue layer;

proximally retracting an anchor of each of the anchor deployers by proximally retracting a filament which is secured thereto;

axially compressing the collapsible tube of each of the plurality of anchor deployers between the respective anchor and lower surface of the tissue layer by applying tension to the filament which is secured to the anchor and which is disposed within an inner lumen of the collapsible tube until the collapsible tube shortens in axial length and expands in an outward radial direction adjacent the passage; and

applying tension to the filaments from a distal section of the housing to reduce a distance between the anchors drawing the anchors and adjacent tissue of the tissue layer radially inward so as to reduce the size of the passage in the tissue layer.

28. The method of claim 27 further comprising proximally withdrawing deployment rods of each of the plurality of anchor deployers from respective anchors and into the distal section of the housing.

29. The method of claim 27 further comprising deploying a filament grip onto the filaments and securing the filaments relative to each other at the filament grip after the size of the passage in the tissue layer has been reduced.

31. The method of claim 27 wherein the collapsible tubes comprise a thrombogenic material, the collapsible tubes are deployed in a blood field below the tissue layer, and further comprising forming thrombus adjacent the collapsible tubes.

32. The method of claim 27 further comprising radially expanding and axially collapsing a proximal end of the collapsible tubes against the lower surface of the tissue layer in an outward radial direction while axially compressing the collapsible tubes.

33. The method of claim 32 wherein radially expanding the proximal ends of the collapsible tubes comprises splaying leafs of respective proximal ends of the collapsible tubes that include slits from the proximal ends thereof.

34. The method of claim 27 comprising disposing a flared proximal end of the collapsible tube against the lower surface of the tissue layer and spaced from a lumen formed by the respective anchor deployers.

35. The method of claim 27 comprising crumpling the proximal ends of the collapsible tubes which have a reduced wall thickness against the lower surface of the tissue layer.

36. A hemostasis device, comprising:

a housing including an elongate configuration with an axial length greater than a transverse dimension thereof, a proximal end, a distal end and a distal section;

an anchor deployer comprising;

a deployment rod which is slidably disposed relative to the housing and which includes an elongate resilient configuration and a distal end that extends distally and radially from the distal section of the housing,

an anchor which is removably secured to the distal end of the deployment rod and which is configured to penetrate tissue in a distal direction and prevent tissue penetration in a proximal direction,

a filament which is slidably disposed within the housing and which includes a distal end which is secured to the anchor, and

a collapsible tube disposed over a distal section of the filament proximal of the anchor, the collapsible tube including an elongate configuration having an axial length greater than a transverse dimension thereof and a wall structure that is configured to buckle in an axial orientation upon axial compression.

30. The method of claim 39 wherein deploying the filament grip onto the filaments comprises sliding a self-contracting lock ring in an expanded state from a distal end of the housing and allowing the self-contracting lock ring to contact to a relaxed state over the filaments.

37. The hemostasis device of claim 36 further comprising a handle secured to the proximal end of the housing.

38. The hemostasis device of claim 36 further comprising a rod pusher operatively coupled to the deployment rod.

39. The hemostasis device of claim 36 further comprising a filament tensioner operatively coupled to the filament.

40. The hemostasis device of claim 36 wherein the collapsible tube comprises a distal section which tapers distally to a reduced outer transverse dimension.

41. The hemostasis device of claim 36 wherein the collapsible tube comprises a longitudinal slit in a middle section of a wall thereof.

42. The hemostasis device of claim 41 wherein the collapsible tube comprises a plurality of longitudinal slits in a middle section in the wall thereof.

43. The hemostasis device of claim 36 wherein the collapsible tube comprises a material selected from the group consisting of polyurethane, PET, PEEK, acrylic, silicone, polypropylene, and polyester.

44. The hemostasis device of claim 36 wherein the collapsible tube comprises a thrombogenic material.

45. The hemostasis device of claim 44 wherein the thrombogenic material comprises a material selected from the group consisting of collagen, fibrin, fibrinogen, gelatin, polylactic acid (PLA), polyglycolic acid (PGA), alginate and fibronectin.

46. The hemostasis device of claim 36 wherein the collapsible tube comprises a hydrogel material that swells to a larger volume over time in an aqueous environment.

47. The hemostasis device of claim 46 wherein the hydrogel material comprises a material selected from the group consisting of fibrin, collagen, gelatin, hyaluronic acid, alginate, agarose, poly(ethylene glycol), poly(acrylic acid), poly(vinyl alcohol), polypeptides, and poly(vinyl pyrrolidone).

48. The hemostasis device of claim 36 wherein the collapsible tube comprises a slit through the wall of the tube extending distally from the proximal end of the collapsible tube.

49. The hemostasis device of claim 48 wherein the collapsible tube comprises a plurality of slits through the wall extending distally from the proximal end of the collapsible tube.

50. The hemostasis device of claim 49 wherein the plurality of slits through the wall extending distally from the proximal end of the collapsible tube comprise a length of about 1 mm to about 4 mm.

51. The hemostasis device of claim 36 wherein the wall thickness of the collapsible tube tapers to a reduced wall thickness from a position which is distal of the proximal end of the collapsible tube to a position at the proximal end of the collapsible tube.

52. The hemostasis device of claim 36 wherein the collapsible tube flares proximally to a larger outer transverse dimension from a position which is distal of the proximal end of the collapsible tube to a position at the proximal end of the collapsible tube.

53. The hemostasis device of claim 36 wherein the collapsible tube comprises an axial length of about 3 mm to about 15 mm.

54. The hemostasis device of claim 36 wherein the collapsible tube comprises an outer transverse dimension of about 0.5 mm to about 2 mm.

55. The hemostasis device of claim 36 further comprising a filament grip that is disposed on the distal end of the housing adjacent the filament and which is configured to be secured to the filament and prevent passage of the filament distally through the tissue layer.

56. The hemostasis device of claim 55 wherein the filament grip comprises a lock ring disposed about the filament which includes a self-retracting coil with a central lumen which is disposed about the filament, which is sized to allow free movement of the filament therethrough with the self-retracting coil in an expanded state and which has an interior surface of the central lumen that is configured to compress the filament when in a retracted state.

57. A method of preventing blood leakage from a tissue layer, comprising:

disposing a distal end of a housing of a hemostasis device at a position adjacent the tissue layer;

deploying an anchor deployer from a distal section of the housing in a distal direction from the housing into the tissue layer;

penetrating the tissue layer with the anchor deployer and extending the anchor deployer distally through the tissue layer until a proximal end of a collapsible tube of the anchor deployer extends distally beyond a lower surface of the tissue layer;

proximally retracting an anchor of the anchor deployer by proximally retracting a filament which is secured thereto; and

axially compressing the collapsible tube between the anchor and lower surface of the tissue layer by applying tension to the filament which is secured to the anchor and which is disposed within an inner lumen of the collapsible tube until the collapsible tube shortens in axial length and expands in an outward radial direction.

58. The method of claim 57 wherein deploying the anchor deployer comprises distally advancing a deployment rod in a distal direction and further comprising proximally withdrawing the deployment rod from the anchor and into the distal section of the housing.

59. The method of claim 57 further comprising deploying a filament grip onto the filament and securing the filament to prevent distal movement of the filament through the tissue layer.

60. The method of claim 59 wherein deploying the filament grip onto the filament comprises sliding a self-contracting lock ring in an expanded state from a distal end of the housing and allowing the self-contracting lock ring to contact to a relaxed state over the filament.

61. The method of claim 57 wherein the collapsible tube comprises a thrombogenic material, the collapsible tube is deployed in a blood field below the tissue layer, and further comprising forming thrombus adjacent the collapsible tube.

62. The method of claim 57 further comprising radially expanding and axially collapsing a proximal end of collapsible tube against the lower surface of the tissue layer in an outward radial direction while axially compressing the collapsible tube.

63. The method of claim 62 wherein radially expanding the proximal end of the collapsible tube comprises splaying leafs of a proximal end of the collapsible tubes that includes slits from the proximal end thereof.

64. The method of claim 57 comprising disposing a flared proximal end of the collapsible tube against the lower surface of the tissue layer which is spaced from a puncture hole formed by the deployment of the anchor deployer.

65. The method of claim 57 further comprising crumpling the proximal end of the collapsible tube which has a reduced wall thickness against the lower surface of the tissue layer.