Closure device and method

• US 5,964,782 A
• Filed: 09/18/1997
• Issued: 10/12/1999
• Est. Priority Date: 09/18/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Harrison, Kent D., Lafontaine, Daniel M.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/932,990
• Time in Patent Office: 754 Days
• Field of Search: 606/149, 606/139, 606/213, 606/148, 606/144
• 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 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• 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 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00279 deployable

Abstract

An apparatus is provided for closing a perforation in a wall of a patient'"'"'s blood vessel or other organs, and a method of introducing the apparatus and causing the closure are described. The apparatus includes an elongated support member having a distal end supporting one or more tissue engaging hooks configured to engage fibrous vessel tissue when moved in a first direction and to disengage the tissue when moved in a second direction, and a proximal end for applying rotational torque to the support member to cause the hooks to engage collagen fibrous tissue in the adventitia of the blood vessel or fibrous tissue in other body organs. The hooks engaging the collagen fiber causes the blood vessel tissue surrounding the perforation to be drawn into close proximity such that the perforation can be closed. The apparatus can be removed by applying reverse rotation of the support member, whereby the hooks are disengaged. The apparatus is deployed in an outer sheath with the hooks encased until a selected engaging location has been achieved. When positioned in the aperture to be closed, the hooks are exposed to allow interaction with the adventitia. Puncture closure can be accomplished by various techniques, including stasis, cauterizing, or by clamping. Various embodiments of the apparatus are described.

Claims

1. For use in closing an aperture in a body organ having at least a fibrous portion in proximity to the aperture, a closing device comprising:

support means having a distal end for extending through the aperture beyond the fibrous portion in proximity to the aperture to be closed and having a proximal end for selectively providing a first manipulation and a second manipulation;

engaging means mounted at said distal end of said support means, for engaging the fibrous portion in proximity to the aperture, whereby said first manipulation of said support means causes the aperture to be closed by said engaging means; and

sealing means for causing the closed aperture to be sealed, wherein said sealing means includes cauterizing means for cauterizing the closed aperture, said sealing means being connected to said support means.

2. A closing device as in claim 1, and further including:

delivering means for delivering said support means and said engaging means to an operative proximity with the aperture, said delivery means being slidably connected to said support means.

3. A closing device as in claim 2, wherein said delivery means includes:

positioning means for locating said engaging means within the aperture.

4. A closing device as in claim 3, wherein said positioning means includes blood flow detecting means for detecting the presence of blood flow during positioning.

5. A closing device as in claim 2, wherein said engaging means include hooks means arranged in a predetermined configuration for responding to said first manipulation to engage the fibrous portion for closing the aperture.

6. A closing device as in claim 5, wherein said hook means includes a plurality of hook members each having at least a flexible portion deflected within said delivery means, for extending said plurality of hooks members beyond said delivery means when said support means is moved within said delivery means.

7. An improved method of closing an aperture in the wall of an blood vessel, wherein the blood vessel has a lumen carrying blood, an outer facia, an adventitia layer, and a media layer, said method comprising the steps of:

a. inserting a plurality of hooks through the aperture into the lumen;

b. extending the plurality of hooks to engage the adventitia layer surrounding the aperture;

c. withdrawing the plurality of hooks through the media layer to engage the adventitia layer;

d. manipulating the plurality of hooks to cause the engaged adventitia to close the aperture; and

e. sealing the closed aperture, wherein the step of sealing includes cauterizing the closed aperture.

8. The method of claim 7, wherein the step of sealing includes clamping engaged adventitia between the plurality of hooks and a sealing ring.

9. The method of claim 7, and further including the step of:

occluding the flow of blood from the lumen out through the aperture during steps a-c.

10. The method of claim 7, and further including the step of:

sensing blood flow through the aperture for positioning the plurality of hooks prior to preforming step a.

11. For use in closing an opening in a blood vessel having a lumen carrying blood and collagen fibrous tissue in proximity to the opening, a closing device comprising:

a support member having an outer surface, a proximal end, a distal end, and having a length sufficient to place said distal end in proximity to the opening;

a plurality of hooks mounted in a predetermined pattern on said outer surface in predetermined proximity to said distal end, and adapted to cooperate with and to engage the fibrous tissue when said support member is actuated, wherein said support member includes a compliant inflatable balloon having a predetermined length, a distal atraumatic tip portion, and a proximal portion supporting said plurality of hooks.

12. A closing device as in claim 11, wherein said support member comprises an elongated flexible tube.

13. A closing device as in claim 12, wherein said elongated flexible tube has a diameter up to about 45 F.

14. A closing device as in claim 12, wherein said elongated flexible tube is constructed of stainless steel.

15. A closing device as in claim 11, wherein said plurality of hooks extend outwardly from said outer surface in a predetermined fibrous tissue hooking configuration.

16. A closing device as in claim 15, wherein each of said plurality of hooks is smooth, as a predetermined cross-section, and is adapted to cooperate with and engage the fibrous tissue when moved in a first manner and to release the fibrous tissue when moved in a second manner.

17. A closing device as in claim 15, wherein said plurality of hooks are constructed of atraumatic material selected from the class of materials including flexible plastic, Nitinol, stainless steel, plastic with dissolvable protective coating, hydroplastic and bio-absorbable plastic.

18. A closing device as in claim 11, wherein said plurality of hooks extend outwardly from said proximal portion in predetermined hooking configuration.

19. A closing device as in claims 18, wherein each of said plurality of hooks is smooth, has a predetermined cross-section and is adapted to cooperate with and engage the fibrous tissue when said support member is actuated in a first manner and to release the fibrous tissue when said support member is actuated in a second manner.

20. For use in closing an opening in a blood vessel, the blood vessel having a lumen carrying blood and fibrous tissue in proximity to the opening, a closing device comprising:

a heating element having a distal end, a proximal end, and a tip surface at said distal end;

a support member having a first end coupled to said proximal end and having a length sufficient to position said distal end in proximity to the opening, and a second end to manipulate said heating element; and

a plurality of hooks mounted in a predetermined pattern on said tip surface and arranged to engage the fibrous tissue when said second end is manipulated in a first direction and to release the fibrous tissue when said second end is manipulated in a second direction.

21. A closing device as in claim 20, and further including a power circuit coupled to said heating element.

22. A closing device as in claim 21, wherein said power circuit includes a radiofrequency source.

23. A closing device as in claim 22, and further including a delivery mechanism having a distal portion and a proximal portion, said heating element having a first position enclosed within said delivery mechanism until positioned near the opening and said heating element having a second position extending distally of said delivery mechanism.

24. A closing device as in claim 23, wherein said plurality of hooks extend outwardly from said tip surface in a predetermined hooking configuration.

25. A closing device as in claim 24, wherein said plurality of hooks are constructed of atraumatic material selected from the class of materials including flexible plastic, Nitinol, stainless steel, plastic with dissolvable protective coating, hydroplastic and bio-absorbable plastic.

26. A closing device as in claim 24, wherein said plurality of hooks are affixed to said tip surface by heat releasing glue.

27. A closing device as in claim 24, wherein said plurality of hooks are made of bio-absorbable material.

28. A closing device as in claim 24, wherein said plurality of hooks are made of material wherein said plurality of hooks are made of temperature sensitive material wherein each of said plurality of hooks maintains a hooking configuration at a first temperature and relaxes to a substantially straightened releasing configuration at a second temperature.

29. For use in closing an opening in a blood vessel utilizing the adventitia in proximity to the opening, a closing device comprising:

a support mechanism having a distal end, a proximal end, and a predetermined length sufficient to position said distal end through the opening while said proximal end is externally manipulatable;

a plurality of hooks coupled to said distal end, and arranged to engage the adventitia when said support member is manipulated, wherein each of said plurality of hooks includes a hooking portion, a shank portion, and a proximal interconnecting portion; and

a closure mechanism to engage said plurality of hooks and close the opening, wherein said closure mechanism includes an annular ring portion having an inner annular surface, a locking structure mounted to said inner annular surface and arranged to cooperate with said shank portion of each of said plurality of hooks, a peripheral surface on said locking structure, a first portion extending outwardly a predetermined distance from said peripheral surface, and a second annular portion extending toward said plurality of hooks.

30. A closing device as in claim 29, wherein said predetermined distance is selected to cause said second annular portion to cooperate with said plurality of hooks to secure adventitia therebetween.

31. A closing device as in claim 30, wherein each said shank portion includes retention protrusions to cooperate with said locking structure.

32. For use in closing an opening in a blood vessel utilizing the adventitia in proximity to the opening, a closing device comprising:

a positioning probe having a distal tip and a predetermined length sufficient to locate said distal tip through the opening, said positioning probe having a longitudinal channel along a predetermined portion of said predetermined length, said longitudinal channel having a proximal opening and a distal opening at said distal tip;

an electrode having a head portion having a distal end and configured to slidably cooperate with said longitudinal channel from said proximal opening to said distal opening, and having a handle portion to manipulate said head portion; and

a plurality of hooks mounted on said distal end and arranged to engage the adventitia when said handle portion is manipulated.

33. A closing device as in claim 32, and further including:

a source of radiofrequency power coupled to said electrode to cauterize the closed opening.

34. A closing device for use in closing a perforation in a body organ having fibrous tissue adjacent to at least a portion of the perforation, the closing device comprising:

an elastic material ring having an inner surface, an outer surface, a predetermined length, and first and second ends, said elastic material ring capable of having a stretched position and a relaxed position;

a plurality of fibrous tissue engaging members mounted on said outer surface; and

a hook and pile structure mounted on said inner surface.

35. A closing device as in claim 34, and further including a suture mechanism coupled to said elastic material ring.

36. A closing device as in claim 34, wherein said elastic material ring, said plurality of fibrous tissue engaging members, and said hook and pile structure are fabricated from bio-absorbable material.

37. A closing device as in claim 34, and further including:

a positioning device to position said elastic material ring in said stretched position to a location in proximity of the fibrous tissue;

an activation mechanism to cause said plurality of fibrous tissue engaging members to engage the fibrous tissue; and

a release mechanism coupled to said activation mechanism to cause said elastic material to be released, thereby allowing said elastic material ring to assume said released position to thereby cause said hook and pile structure to engage, whereby said elastic material ring closes the perforation.

38. A closing device as in claim 37, wherein said elastic material ring further includes suture material coupled thereto, whereby said suture material can be utilized to draw said elastic material ring into a tightly relaxed position to thereby firmly engage said hook and pile structure, whereby the elastic material ring tightly closes the perforation.

39. A closing device as in claim 38, wherein said positioning device includes blood flow ports to allow blood flow to be detected for use in positioning said elastic material ring.

40. For use in closing an opening in a blood vessel having a lumen carrying blood and collagen fibrous tissue in proximity to the opening, a closing device comprising:

a support member having an outer surface, a proximal end, a distal end, and having a length sufficient to place said distal end in proximity to the opening;

a plurality of hooks mounted in a predetermined pattern on said outer surface in predetermined proximity to said distal end, and adapted to cooperate with and to engage the fibrous tissue when said support member is actuated, and further including a closure mechanism, wherein said closure mechanism includes a plurality of engaging members to engage the fibrous tissue when brought in contact by said plurality of hooks, wherein said closure mechanism includes a selectively actuatable electrode.

41. A closing device as in claim 40, wherein said closure mechanism includes a locking ring to lock in cooperation with said plurality of hooks to thereby engage at least the fibrous tissue therebetween.

42. A closing device as in claim 41, wherein said locking ring and said plurality of hooks are bio-absorbable.

43. A closing device as in claim 40, and further including:

a delivery mechanism having a distal portion and a proximal portion, said delivery mechanism having a positioning mode to encase said plurality of hooks and at least a portion of a said support member to allow insertion of said distal portion of said delivery mechanism and said distal end of said support member through the opening, and said delivery mechanism having a closure mode to expose said plurality of hooks in proximity to the fibrous tissue at the opening to allow said plurality of hooks to be manipulated by said support mechanism for effecting closure of the opening.

44. A closing device as in claim 43, and further including:

a blood flow detecting structure to aid in positioning said distal portion of said delivery mechanism through the opening into the lumen.

45. For use in closing an opening in a blood vessel utilizing the adventitia in proximity to the opening, a closing device comprising:

a support mechanism having a distal end, a proximal end, and a predetermined length sufficient to position said distal end through the opening while said proximal end is externally manipulatable;

a plurality of hooks coupled to said distal end, and arranged to engage the adventitia when said support member is manipulated, wherein each of said plurality of hooks includes a hooking portion, a shank portion, and a proximal interconnecting portion; and

a closure mechanism to engage said plurality of hooks and close the opening, wherein said proximal interconnecting portion of each of said plurality of hooks is coupled to said support mechanism by dissolvable glue.

46. A closing device as in claim 45, wherein said plurality of hooks and said closure mechanism are fabricated from bio-absorbable plastic.

47. For use in closing an opening in a blood vessel utilizing the adventitia in proximity to the opening, a closing device comprising:

a support mechanism having a distal end, a proximal end, and a predetermined length sufficient to position said distal end through the opening while said proximal end is externally manipulatable;

a plurality of hooks coupled to said distal end, and arranged to engage the adventitia when said support member is manipulated, wherein each of said plurality of hooks includes a hooking portion, a shank portion, and a proximal interconnecting portion; and

a closure mechanism to engage said plurality of hooks and close the opening, wherein said support mechanism includes a plurality of distal connecting members each having a distal interconnection portion, each of said plurality of distal connecting members coupled to a respective one of said plurality of hooks.

48. A closing device as in claim 47, wherein said plurality of distal connecting members are substantially parallely aligned during positioning and are biased to urge said plurality of hooks to a separated position.

49. A closing device as in claim 48, wherein said closure mechanism includes:

an annular ring portion having an inner annular surface; and

a locking structure mounted to said inner annular surface, and arranged to cooperate with said shank portion of each of said plurality of hooks.

50. A closing device as in claim 49, wherein said closure mechanism includes:

a peripheral surface on said locking structure;

a first annular portion extending outwardly a predetermined distance from said peripheral surface; and

a second annular portion extending toward said plurality of hooks.

51. A closing device as in claim 50, wherein said predetermined distance is selected to cause said second annular portion to cooperate with said plurality of hooks to secure adventitia therebetween.

52. A closing device as in claim 51, wherein each said shank portion includes retention protrusions.

53. A closing device as in claim 52, wherein said proximal interconnecting portion of each of said plurality of hooks is coupled to said support mechanism by dissolvable glue.

54. A closing device as in claim 48, and further including:

a positioning mechanism surrounding said support mechanism and said plurality of hooks, said positioning mechanism having a distal end, and adapted to position said plurality of hooks in proximity within the opening; and

a deployment mechanism within said positioning mechanism and movably positionable along said support mechanism to position said closure mechanism in a closing relationship with said plurality of hooks.

55. A closing device as in claim 54, and further including:

a releasing mechanism to cooperate with and release said plurality of hooks from said support mechanism.