Tissue aperture securing and sealing apparatuses and related methods of use

• US 20080287988A1
• Filed: 04/08/2008
• Published: 11/20/2008
• Est. Priority Date: 05/17/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Weitzner, Barry, Golden, John, Smith, Paul J.
• Granted Patent: US 9,545,258 B2
• Time in Patent Office: Days
• US Class Current: 606/216
• 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 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• 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 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06042 : located close to needle tip
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body

Abstract

Embodiments of the invention may be directed to apparatuses for securing and sealing apertures in tissue and related methods of use.

Claims

1. An apparatus for collapsing an aperture in a wall of tissue, comprising:

a base; and

a plurality of collapsible fingers extending from the base,

wherein the collapsible fingers are configured to collapse about tissue adjacent to and defining the aperture so as to close the aperture in the wall of tissue.

2. The apparatus of claim 1, wherein the base defines a gap in an expanded state of the base, the base further having a collapsed state without the gap.

3. An assembly including the apparatus of claim 1 and a delivery apparatus, the delivery apparatus comprising:

an elongate flexible member; and

a distal assembly connected to the elongate flexible member,

wherein the distal assembly is configured to accommodate the apparatus.

4. The assembly of claim 3, wherein the base defines an aperture for receiving the distal assembly therethrough.

5. The assembly of claim 3, wherein the distal assembly includes a distal tip configured to puncture the wall of tissue and form the aperture.

6. The assembly of claim 3, wherein the distal assembly includes a member and a stepped portion configured to accommodate the base,

wherein a cross-sectional area of the stepped portion is larger than a cross-sectional area of the member immediately proximal to the stepped portion.

7. The assembly of claim 6, wherein an outer surface of the base lies essentially flush with a surface of the distal assembly that is distal to the stepped portion.

8. The assembly of claim 3, wherein the distal assembly includes at least one strand connected to the base,

wherein the at least one strand is configured to assist in positioning the apparatus about the aperture to be closed.

9. The assembly of claim 8, wherein the at least one strand is connected to the distal assembly.

10. The assembly of claim 9, wherein a distal end of the elongate member includes a notch configured to accommodate the at least one strand therethrough,

wherein the notch is configured to allow the at least one strand to assist in deploying the base about the distal end of the elongate member.

11. The apparatus of claim 1, wherein at least a portion of the base is configured to overlap with another portion of the base, and

wherein at least some of plurality of fingers are configured to overlap others of the plurality of fingers.

12. A method of closing an aperture in a wall of tissue, comprising:

providing an apparatus including a base and a plurality of collapsible fingers extending from the base;

providing a delivery apparatus including an elongate member;

advancing the apparatus through the body lumen via the delivery apparatus;

expanding the apparatus around the aperture; and

collapsing the apparatus about tissue adjacent to and defining the aperture so as to close the aperture.

13. The method of claim 12, wherein the delivery apparatus further includes a distal assembly, the apparatus being disposed about the distal assembly.

14. The method of claim 13, wherein during the step of expanding the apparatus a gap is formed in the base.

15. The method of claim 13, wherein the base defines an aperture for receiving the distal assembly therethrough.

16. The method of claim 13, further comprising forming the aperture by advancing a distal tip of the distal assembly through the wall of tissue.

17. The method of claim 13, wherein the distal assembly includes a member and a stepped portion configured to accommodate the base,

wherein a cross-sectional area of the stepped portion is larger than a cross-sectional are of the member immediately proximal to the stepped portion,

the method further comprising expanding the base so as to move the base over and distal to the stepped portion.

18. The method of claim 13, wherein the distal assembly includes at least one strand connected to the base,

the method further comprising placing a proximal force on the at least one strand so as to assist in positioning the apparatus about the aperture to be closed.

19. The method of claim 18, wherein the at least one strand is connected to the distal assembly,

the method further comprising retracting the distal assembly in the proximal direction so as to place the proximal force on the at least one strand.

20. The method of claim 18, wherein a distal end of the elongate member includes a notch configured to accommodate the at least one strand therethrough,

the method further comprising disposing the at least one strand in the notch;

and

deploying the base about the distal end of the elongate member.

21. The method of claim 18, further comprising detaching the at least one strand from the base so as to collapse the apparatus.

22. The method of claim 12, further comprising overlapping at least a portion of the base with another portion of the base, and

overlapping at least some of plurality of fingers with others of the plurality of fingers.

23. A method of closing an aperture in a wall of tissue, comprising:

providing an apparatus including an elongate member including a first end and a second end, each of the first end and the second end including a hook;

advancing the apparatus to a first side of the wall;

advancing the first and second ends through the aperture to a second side of the wall;

after advancing the first and second ends through the aperture, advancing the first and second ends through the wall to the first side of the wall; and

coupling the first and second ends together so as to close the aperture.

24. The method of claim 23, wherein the apparatus includes a plurality of apparatuses.

25. The method of claim 23, wherein coupling includes tying.

26. The method of claim 23, wherein the first and second ends each form individual apertures on substantially opposite sides of the aperture.

27. The method of claim 23, further comprising providing a tool for use with the apparatus, the tool including a distal assembly configured to accommodate the hooks of the apparatus in a substantially straight configuration;

and

advancing at least a portion of the distal assembly through the aperture,

wherein the step of advancing the first end through the wall includes advancing the first end out of the distal assembly such that the hook reverts to a hooked configuration.

28. The method of claim 27, wherein the distal assembly defines a plurality of inner channels, the plurality of inner channels being substantially parallel to a longitudinal axis of the distal assembly;

wherein the hook is disposed in the one of the plurality of inner channels in a substantially straight configuration.

29. The method of claim 27, wherein at least one of the elongate member and the distal assembly defines a plurality of slots,

wherein the step of advancing the first end out of the distal assembly includes advancing the first end out of one of the plurality of slots.

30. An apparatus, comprising:

an elongate member;

a distal assembly connected to the elongate member;

a plurality of inner channels defined by the distal assembly, the plurality of inner channels being substantially parallel to a longitudinal axis of the distal assembly;

a plurality of slots defined by at least one of the elongate member and the distal assembly; and

a hook disposed in one of the plurality of inner channels, the hook being disposed in the one of the plurality of inner channels in a substantially straight configuration,

wherein the distal assembly is configured so that the hook may be advanced out of the one of the plurality of inner channels through one of the plurality of slots.

31. An apparatus, comprising:

a plurality of hooks configured to be disposed in a wall of tissue;

at least one strand connecting the plurality of hooks; and

a tool configured to detachably accommodate the plurality of hooks, the tool including a perforation configured to accommodate a medical device therethrough.

32. The apparatus of claim 31, wherein the perforation is biased toward a closed configuration when not accommodating a medical device therethrough.

33. The apparatus of claim 31, wherein the tool includes a septum with a slit, the slit being configured to accommodate the medical device therethrough.

34. The apparatus of claim 31, wherein the plurality of hooks are disposed around the perforation when the plurality of hooks are attached to the tool.

35. The apparatus of claim 31, wherein the at least one strand connects the plurality of hooks such that when the plurality of hooks are disposed in the wall of tissue, placing a proximal force on the at least one strand causes the plurality of hooks to move closer together.

36. The apparatus of claim 31, wherein a portion of the plurality of hooks are detachably secured to a plurality of apertures in the tool.

37. A method of closing an aperture in a wall of tissue, comprising:

providing a plurality of hooks;

distally advancing the plurality of hooks through a body and embedding each of the plurality of hooks in a wall of tissue around an aperture;

connecting the plurality of hooks via a strand; and

placing a proximal force on the strand so as to bring the plurality of hooks closer together and close the aperture.

38. The method of claim 37, further comprising providing a tool, the plurality of hooks being detachably attached to a distal end of the tool;

and

after the step of embedding, detaching the plurality of hooks from the distal end of the tool.

39. The method of claim 38, wherein the tool includes a perforation configured to accommodate a medical device therethrough,

the method further comprising biasing the perforation toward a closed configuration when not accommodating the medical device therethrough.

40. The method of claim 38, wherein the tool includes a septum with a slit, the slit being configured to accommodate the medical device therethrough.

41. The method of claim 38, wherein a portion of the plurality of hooks are press-fit into a plurality of apertures in the tool.

42. A method of closing an aperture in a wall of tissue, comprising:

providing an apparatus including a plurality of hooks, each of the hooks being connected to an elongate member;

distally advancing the apparatus to a first side of the wall;

distally advancing each of the plurality of hooks through the aperture to a second side of the wall;

after advancing each of the plurality of hooks through the aperture, advancing each of the plurality of hooks through the wall to the first side of the wall;

placing the plurality of elongate members through a connector; and

proximally advancing the plurality of elongate members through the connector so as to bring the plurality of hooks closer together and close the aperture.

43. The method of claim 42, wherein the connector includes a portion of the elongate member of one of the hooks.

44. The method of claim 42, further comprising after the step of proximally advancing the plurality of elongate members, placing a collar around at least some of the plurality of elongate members at a location proximal to the connector.

45. The method of claim 42, wherein the step of proximally advancing the plurality of elongate members includes proximally advancing at least some of the plurality of elongate members in substantially the same direction.

47. The method of claim 42, wherein the step of proximally advancing the plurality of elongate members includes proximally advancing at least some of the plurality of elongate members in different directions.

48. A method of closing an aperture in a wall of tissue, comprising:

providing a strand in a preformed configuration including a plurality of loops;

distally advancing the strand to a first side of the wall, through an aperture in the wall, to a second side of the wall;

proximally retracting the plurality of loops of the strand, through a plurality of individual apertures, from the second side of the wall to the first side of the wall; and

placing a proximal force on at least some of the plurality of loops so as to shorten a length of the strand disposed on the second side of the wall and close the aperture,

wherein the plurality of individual apertures are disposed around the aperture.

49. The method of claim 48, wherein the preformed configuration includes a square knot.

50. The method of claim 48, further comprising providing a tool including a distal end having a plurality of hooks;

placing the plurality of loops on the plurality of hooks; and

proximally advancing the tool so as to place the proximal force on the strand.

51. The method of claim 48, further comprising providing an elongate member configured to accommodate the strand in the preformed configuration,

wherein the step of distally advancing includes distally advancing the strand via the elongate member.

52. The method of claim 51, wherein during the step of distally advancing, the strand is disposed within the elongate member.

53. The method of claim 51, wherein during the step of distally advancing, the strand is removably attached to an exterior surface of the elongate member.

54. The method of claim 48, wherein in the preformed configuration the plurality of loops are disposed in a substantially proximal direction.

55. An assembly for delivering an apparatus for closing an aperture in a wall of tissue, comprising:

an elongate flexible member having a proximal portion, a distal portion, and a lumen extending between the proximal portion and the distal portion; and

a distal assembly connected to the distal portion of the elongate flexible member, wherein the distal assembly includes a distal tip, wherein the distal assembly is configured to accommodate the apparatus on a portion that is proximal to the distal tip, and wherein the distal tip is configured to invert during delivery of the apparatus.

56. The assembly of claim 55, wherein the apparatus is disposed about the distal assembly.

57. The assembly of claim 55, wherein the apparatus includes a base and a plurality of collapsible fingers extending from the base.

58. The assembly of claim 57, wherein the apparatus is configured to move between collapsed and expanded configurations.

59. The assembly of claim 55, wherein the distal tip is configured to pierce tissue.

60. A system for closing an aperture in a wall of tissue, comprising:

an elongate member having a proximal portion, a distal portion, and a lumen extending therebetween;

an apparatus for closing the aperture mounted about the distal portion of the elongate member, wherein the apparatus is configured to move between a first delivery configuration and a second deployed configuration; and

an actuator for moving the apparatus from the first delivery configuration to the second deployed configuration.

61. The system of claim 60, wherein the apparatus includes a base and a plurality of fingers extending from the base.

62. The system of claim 61, wherein the fingers are disposed radially about the base.

63. A system for closing an aperture in a wall of tissue, comprising:

a first elongate member having a proximal portion, a distal portion, and a lumen extending therebetween;

a second elongate member having a proximal portion, a distal portion, and a lumen extending therebetween, wherein the second elongate member is slidably disposed within the lumen of the first elongate member;

an actuating head connected to the distal portion of the second elongate member; and

an apparatus for closing the aperture, wherein the apparatus is mounted about the actuating head.

64. The system of claim 63, wherein the actuating head includes a lumen in fluid communication with the lumen of the second elongate member.

65. The system of claim 63, wherein the apparatus includes a base and a plurality of collapsible fingers extending from the base, wherein the collapsible fingers are configured to collapse about tissue adjacent to and defining the aperture so as to close the aperture in the wall of the tissue.

66. The system of claim 65, wherein the apparatus is configured to move between a first collapsed configuration and a second expanded configuration.

67. The system of claim 66, wherein sliding the second elongate member proximally moves the apparatus from the first collapsed configuration to the second expanded configuration.

68. An assembly for delivering an apparatus for closing an aperture in a wall of tissue, comprising:

an elongate flexible member having a proximal portion, a distal portion, and a lumen extending between the proximal portion and the distal portion; and

a member having a proximal portion and a distal portion slidably disposed within the lumen of the elongate flexible member;

an apparatus disposed about the distal portion of the member, wherein the apparatus is retained within the lumen of the elongate flexible member in a collapsed configuration, and wherein the apparatus is configured to partially expand when the apparatus is advanced out of the lumen of the elongate flexible member; and

an actuator for fully expanding the apparatus.

69. A method for maintaining a sterile environment within a lumen of a delivery device when the delivery device is being advanced through a patient'"'"'s body, comprising:

inserting into a patient'"'"'s body a delivery device having a proximal end, a distal end, and a lumen extending between an opening at the proximal end and an opening at the distal end, wherein the opening at the distal end is closed by a distal tip that is removably secured to the opening at the distal end;

advancing the delivery device to a treatment site; and

removing the distal tip to allow access to the treatment site via the lumen.