Hemostatic vessel puncture closure system utilizing a plug located within the puncture tract spaced from the vessel, and method of use

• US 5,411,520 A
• Filed: 02/03/1993
• Issued: 05/02/1995
• Est. Priority Date: 11/08/1991
• Status: Expired due to Fees

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Nash, John, Evans, Douglas
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US08/012,816
• Time in Patent Office: 818 Days
• Field of Search: 606/1, 606/213, 606/215, 606/151, 128/887, 600/32, 604/51, 604/168, 604/900, 623/11
• US Class Current: 606/213
• 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 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2090/032 pressure limiting, e.g. hydrostatic
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 90/03 Automatic limiting or abutting means, e.g. for safety
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: F16G 11/101 deforming the cable by moving a part of the fastener
• CPC Class Codes: Y10S 604/90 Telltale showing entry of blood into body inserted conduit

Abstract

A system, a closure, and method for sealing a percutaneous puncture in a blood vessel. The puncture includes a tract leading to it from the skin of the being. The system includes an introducer sheath, a positioning device, a hemostatic puncture closure, and a deployment instrument. The positioning device positions the introducer sheath at a desired position within the vessel. The deployment instrument includes a tubular carrier having a distal end storing the closure. The carrier is extended via an introducer sheath through the tract and puncture into the blood vessel. The closure comprises a rigid anchor, a spacer member, a compressed collagen plug, and a thin filament connecting them in a pulley-like arrangement. The anchor has a centrally located domed projection. The carrier ejects the anchor through the introducer and puncture and then draws it against the free end of the introducer. The instrument and introducer are then withdrawn together to pull the anchor against the tissue contiguous with the puncture inside the artery and so that the domed portion of the anchor extends through the puncture. Further withdrawal draws the plug and spacer out of the carrier into the puncture tract, whereupon the spacer engages the domed portion of the anchor to prevent the plug from entering the puncture. A tensioning device limits the force applied to the filament. The carrier also includes a tamper which is used to mechanically deform the plug within the tract. Hemostasis occurs rapidly and the plug seals the tract.

Claims

1. A method of sealing a small percutaneous puncture in a blood vessel of a living being, the percutaneous puncture comprising an opening in the vessel and a tract contiguous therewith extending through tissue overlying the vessel, said method comprising providing a closure comprising anchoring means, sealing means, and spacer means, inserting said anchor means within the vessel so that a first portion of said anchor means is in engagement with the interior of the vessel contiguous with the opening and a second portion is located within said opening, introducing said sealing means and said spacer means within the tract so that said sealing means is located spaced from the vessel, with said spacer means interposed between said sealing means and said anchor means, moving said spacer means to a position spaced from the vessel but engaging said second portion of said anchor means, whereupon said spacer means prevents said sealing means from gaining ingress into the vessel via the opening.

2. The method of claim 1 wherein said closure means additionally comprises filament means, and wherein said method comprises coupling said anchor means, said sealing means and said spacer means together by said filament means, with said spacer means being interposed between said anchor means and said sealing means.

3. The method of claim 2 additionally comprising the step of pulling on said filament means to move said spacer means to a position within the tract spaced from the vessel but engaging said anchor means through the opening in the vessel and to cause said sealing means to engage said spacer means, whereupon said spacer means prevents said sealing means from gaining ingress into the vessel via the opening.

4. The method of claim 3 additionally comprising automatically ensuring that when said filament means is pulled the force applied thereto does not exceed a predetermined maximum value.

5. The method of claim 1 additionally comprising providing said closure means with radio-opaque means so that its position may be determined radiographically.

6. The method of claim 1 additionally comprising providing an introducer sheath and a deployment instrument, said introducer sheath having a distal end and a proximal portion, said deployment instrument having a distal end and a proximal portion, said closure being located within said deployment instrument, inserting said introducer sheath through the tract and the puncture into the interior of the blood vessel, introducing said deployment instrument into said introducer sheath until the distal end of said instrument is located distally of the distal end of said sheath, and utilizing an indicator member to measure the distance which said instrument should be moved proximally with respect to said introducer sheath to test for proper deployment of said anchor member within the blood vessel.

7. The method of claim 6 comprising the steps of holding the introducer sheath to prevent axial movement thereof and moving said introducer instrument proximally with respect thereto, to cause said anchor member to engage on to the distal end of the introducer sheath, whereupon some resistance will be felt by the user by the time that said indicator member has reached a predetermined point with respect to said proximal portion of said introducer sheath.

8. The method of claim 7 additionally comprising the step of retracting said introducer sheath and said deployment instrument together once said resistance is felt by the user by the time that said indicator member has reached said predetermined point, whereupon the anchor member engages the interior of said blood vessel contiguous with the puncture.

9. The method of claim 8 additionally comprising the steps of retracting said introducer sheath and said deployment instrument after said anchor member has engaged said interior of the blood vessel, whereupon said spacer means and said sealing means are pulled out of said deployment instrument and into the tract.

10. The method of claim 8 additionally comprising the steps of retracting said introducer sheath and said deployment instrument after said anchor member has engaged the interior of the blood vessel, whereupon said spacer means and said sealing means are pulled out of said deployment instrument and into the tract.

11. The method of claim 7 wherein said indicator member comprises at least one elongated prong, said prong having engagement means thereon for cooperating with engagement means on said proximal portion of said introducer sheath to effect the simultaneous retraction of said introducer sheath and said deployment instrument.

12. The method of claim 11 wherein said indicator member comprises a pair of opposed prongs, said method additionally comprising squeezing said prongs together to cause the engagement means of said deployment instrument to releasably engage the engagement means of said introducer sheath, whereupon said introducer sheath and said deployment instrument can be retracted simultaneously.

13. A method of sealing a percutaneous puncture in a blood vessel of a living being by providing a system comprising carrier means, introducer means, and closure means, the puncture comprising a tract extending through tissue overlying the vessel, said closure means comprising anchoring means, spacer means, sealing means, and filament means, said filament means connecting said anchoring means to said sealing means with said spacer means interposed therebetween, said introducer means comprising a tubular member having a distal free end, said method comprising the steps of inserting said introducer means into the puncture tract and through the puncture, inserting said carrier means through said introducer means, expelling said anchoring means from said carrier means into the vessel, drawing said anchoring means into engagement with said distal free end of said introducer means, moving said introducer means and said carrier means together to draw said anchoring means into engagement with the interior tissue of the vessel contiguous with the puncture, and drawing on said filament means to pull said anchoring means and said sealing means relative to each other so that said spacer means engages a portion of said anchoring means through the puncture, while preventing said sealing means from gaining ingress into the puncture.

14. The method of claim 13 additionally comprising automatically ensuring that when said filament means is pulled the force applied thereto does not exceed a predetermined maximum value

15. The method of claim 14 additionally comprising introducing tamping means into the tract to tamp said sealing means therein.

16. A system comprising an instrument and a closure for use therewith for sealing a percutaneous puncture in the wall of a blood vessel, the blood vessel having a longitudinal axis, the puncture comprising a tract contiguous with the opening and extending at an angle to the longitudinal axis of the vessel through tissue overlying the vessel, said closure means comprising anchoring means, sealing means, spacer means, and filament means, said anchoring means comprising an elongated, substantially stiff, member orientable with respect to said sealing means, said sealing means being expandable, said filament means being coupled to said anchoring means, said spacer means, and said sealing means, said instrument being insertable into the puncture tract and through the opening in the wall of the vessel for expelling said anchoring member therefrom, said anchoring member being arranged to be brought by said instrument into engagement with the interior tissue of the vessel contiguous with the opening on the inside of the vessel wall and generally parallel to the longitudinal axis of the vessel, said sealing means being arranged to be located within the tract remote from and outside the vessel wall, whereupon said sealing means is expanded to seal the tract from the passage of fluid therethrough, said spacer means being located within the tract interposed between said sealing means and said anchoring member to prevent said sealing means from gaining ingress into the vessel via the opening, said spacer means being spaced from the vessel but engaging said anchoring member through the opening in the vessel wall.

17. The system of claim 16 wherein said spacer means comprises a disk-like member having at least one passageway therein through which said filament extends.

18. The system of claim 16 wherein said spacer means comprises a resorbable material.

19. The system of claim 18 wherein said spacer means comprises a radio-opaque material.

20. The system of claim 16 wherein said instrument comprises a tubular carrier means in which a portion of said closure is located, and wherein said system additionally comprises an introducer through which said instrument is inserted into said puncture, said introducer comprising a distal free end portion and a proximal portion at which hemostatic valve means is located, said carrier means being arranged to pass through said hemostatic valve means.

21. The system of claim 20 wherein said tubular carrier means is formed of a material to enable it to flex and has a distal end portion for holding said sealing means and said spacer therein, and wherein said system additionally comprises a bypass sleeve disposed on the distal end of said tubular carrier for holding said anchoring member therein, said bypass sleeve being arranged to pass into said hemostatic valve to enable said carrier means to pass therethrough.

22. The system of claim 20 wherein said system additionally comprises position indicating means to provide a visual indication when said distal free end of said introducer means is located within the interior of the vessel and adjacent the puncture.

23. The system of claim 16 additionally comprising tensioning means mounted to a portion of said instrument and coupled to said filament means for preventing a force in excess of a predetermined maximum value from being applied to said filament means during the positioning of said closure means to seal the puncture.

24. The system of claim 23 wherein said tensioning means comprises a ball, a ball seat, an a relieved recess in a portion of the periphery of said ball seat, and spring means to bias said ball against said seat, with said filament extending within said relieved recess between said ball and said seat.

25. The system of claim 24 wherein said instrument comprises a tubular carrier means in which said closure is located, and wherein said instrument comprises a recess in which a supply of said filament means is located, with a portion of said filament means extending through said tensioning means, and down said tubular carrier means to said closure means.

26. The system of claim 25 wherein said filament means comprises a resorbable suture.

27. The system of claim 23 wherein said filament means comprises a resorbable suture.

28. The system of claim 16 wherein said instrument comprises a housing portion arranged to be held in the hand of a user, and wherein said instrument comprises a tubular carrier means in which a portion of said closure is located, said tubular carrier means having a proximal end releasably secured by a snap-fitting coupling located within said housing portion.

29. The system of claim 28 additionally comprising tensioning means located within said housing portion for preventing a force in excess of a predetermined maximum value from being applied to said filament means during the positioning of said closure means to seal the puncture.

30. The system of claim 29 wherein said tensioning means comprises a ball, a ball seat, an a relieved recess in a portion of the periphery of said ball seat, and spring means to bias said ball against said seat, with said filament extending within said relieved recess between said ball and said seat.

31. The system of claim 30 wherein said instrument comprises a tubular carrier means in which said closure is located, and wherein said instrument comprises a recess in which a supply of said filament means is located, said recess being located within the housing means, a portion of said filament means extending through said tensioning means, and down the tubular carrier means to said closure means.

32. The system of claim 16 wherein said anchoring means comprises an elongated member having a lower surface, and an upper surface having a generally domed projection at an intermediate point therealong, said upper surface being arranged to engage the interior of the blood vessel contiguous with said puncture so that said domed projection extends through said puncture, whereupon said spacer member is seated on top of said domed projection.

33. The system of claim 32 wherein said domed projection includes an opening through which said filament means extends.

34. The system of claim 32 wherein said sealing means is formed of a resorbable hemostatic material and wherein said anchoring means is formed of a resorbable non-hemostatic material.

35. The system of claim 34 wherein said sealing means is formed of collagen.

36. The system of claim 35 wherein said collagen is compressed prior to introduction into the body of the being and is arranged to automatically expand in the presence of blood.

37. The system of claim 16 additionally comprising tamping means arranged to be slid along said filament means to tamp said sealing means into the tract to cause said sealing means to spread out therein.

38. The system of claim 37 wherein said tamping means is mounted on said filament and arranged to slide therealong.

39. The system of claim 38 wherein said filament means is arranged to be pulled to cause said tamping means to be ejected from said instrument.

40. The system of claim 16 wherein said sealing means is formed of collagen.

41. The system of claim 40 wherein said collagen is compressed prior to introduction into the body of the being and is arranged to automatically expand in the presence of blood.

42. The system of claim 16 wherein said sealing means is formed of a resorbable hemostatic material and wherein said anchoring means is formed of a resorbable non-hemostatic material.

43. A closure for sealing a percutaneous puncture in a blood vessel having a longitudinal axis, the puncture comprising an opening in the vessel and a tract contiguous therewith extending at an angle to the longitudinal axis of the vessel through tissue overlying the vessel, said closure comprising anchoring means, sealing means, spacer means and filament means, said anchoring means comprising an elongated, substantially stiff, member orientable with respect to said sealing means, said anchoring member, said sealing means and said spacer means being coupled together by said filament means, said anchoring member being orientable with respect to said sealing means and insertable within the vessel so that a first portion thereof extends generally parallel to the longitudinal axis of the vessel and is in engagement with the interior of the vessel contiguous with the opening and with a second portion of said anchor means extending into the opening, said sealing means and said spacer means being insertable within the tract so that said sealing means is located spaced from the vessel, with said spacer means being interposed between said sealing means and said second portion of said anchoring member, said filament means being engagable to move said spacer means to a position spaced from the vessel but with a portion of said spacer means engaging said second portion of said anchoring member, whereupon said spacer means prevents said sealing means from gaining ingress into the vessel via the opening.

44. The closure of claim 43 wherein said spacer means comprises a disk-like member having at least one passageway therein through which said filament extends.

45. The closure of claim 43 wherein said spacer means comprises a resorbable material.

46. The closure of claim 43 wherein said spacer means comprises a radio-opaque material.

47. The system of claim 43 wherein said sealing means is formed of a resorbable hemostatic material and wherein said anchoring means is formed of a resorbable non-hemostatic material.

48. The closure of claim 47 wherein said anchoring member has a lower surface and an upper surface having a generally domed projection at an intermediate point therealong, said upper surface being arranged to engage the interior of the blood vessel contiguous with the puncture so that said domed projection extends through the puncture, whereupon said spacer member is seated on top of said domed projection.

49. The closure of claim 48 wherein said domed projection includes an opening through which said filament means extends.

50. The closure of claim 47 wherein said filament is resorbable.

51. The closure of claim 43 wherein said anchoring member has a lower surface and an upper surface having a generally domed projection at an intermediate point therealong, said upper surface being arranged to engage the interior of the blood vessel contiguous with the puncture so that said domed projection extends through the puncture, whereupon said spacer member is seated on top of said domed projection.

52. The closure of claim 43 wherein said sealing means is formed of collagen.

53. The closure of claim 52 wherein said collagen is compressed prior to introduction into the body of said being and is arranged to automatically expand in the presence of blood.

54. A system for sealing a percutaneous incision or puncture in the wall of a blood vessel of a living being, the blood vessel having a longitudinal axis, said system comprising carrier means, introducer means, and closure means, the puncture comprising a tract extending at an angle to the longitudinal axis through tissue overlying the vessel, said closure means comprising anchoring means, spacer means, sealing means, and filament means, said anchoring means comprising an elongated, substantially stiff member orientable with respect to said sealing means, said filament means connecting said anchoring member to said sealing means with said spacer means interposed therebetween, said introducer means comprising a tubular member having a distal free end arranged to be inserted into the puncture tract and through the puncture in the wall, said carrier means being arranged to be inserted through said introducer means to expel said anchoring member therefrom and to draw said anchoring member into engagement with said distal free end of said introducer means, said introducer means and said carrier means being arranged to be moved together to orient said anchoring member generally parallel to the longitudinal axis of the vessel and to draw said anchoring member into engagement with the interior tissue of the vessel contiguous with the puncture, said filament means being arranged to pull said anchoring member and said spacer means and said sealing means relative to one other, whereupon said spacer means prevents said sealing means from engaging the exterior of the blood vessel contiguous with the puncture.

55. The system of claim 54 wherein said introducer means comprises hemostatic valve means through which said carrier means is arranged to pass.

56. The system of claim 54 wherein said system additionally comprises position indicating means to provide a visual indication when said distal free end of said introducer means is located within the interior of said vessel and adjacent said puncture.

57. The system of claim 54 wherein said system additionally comprises position indicating means to provide a visual indication when said anchor means is in engagement with the distal free end of said introducer means.

58. The system of claim 57 wherein said position indicating means comprises at least one elongated prong on said carrier means, said prong having engagement means thereon for cooperating with engagement means on said introducer means to effect the simultaneous retraction of said carrier means and said introducer means.

59. A closure for sealing a percutaneous puncture in a blood vessel having a longitudinal axis, the puncture comprising an opening in the vessel and a tract contiguous therewith extending at an angle to the longitudinal axis of the vessel through tissue overlying the vessel, said closure comprising anchoring means, sealing means, spacer means and filament means, said anchoring means comprising an elongated, substantially stiff member orientable with respect to said sealing means, said anchoring member and said sealing means being coupled together by said filament means, said anchoring member being insertable within the vessel so that it extends generally parallel to the longitudinal axis of the vessel, with a first portion of said anchoring member being in engagement with the interior of the vessel contiguous with the opening and with a second portion of said anchoring member extending into the opening, said sealing means and said spacer means being insertable within the tract so that said sealing means is located spaced from the vessel, with said spacer means being interposed between said sealing means and said second portion of said anchoring member and in engagement with said second portion of said anchoring member, whereupon said spacer means prevents said sealing means from gaining ingress into the vessel via the opening.

60. The closure of claim 59 wherein said spacer means comprises a separate component of said closure and is coupled via said filament means to said anchoring means and said sealing member.