Apparatus and methods for providing tactile feedback while delivering a closure device

• US 7,842,068 B2
• Filed: 11/30/2001
• Issued: 11/30/2010
• Est. Priority Date: 12/07/2000
• Status: Expired due to Fees

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Ginn, Richard S.
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T.
• Assistant Examiner(s): Dornbusch; Dianne
• Application Number:
  US10/006,400
• Publication Number:
  US 20020072768A1
• Time in Patent Office: 3,287 Days
• Field of Search: 606/1, 606215-221, 606/213, 606139-159, 606190-200, 128/887, 600201-210
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• 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 2017/00663 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 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 34/76 Manipulators having means for providing feel, e.g. force or tactile feedback

Abstract

An apparatus for sealing a passage through tissue includes a tubular member, a plug, and a locator member. The plug is disposed on a distal end of the tubular member and includes an external thread. The locator member is inserted into a lumen of the tubular member until a distal portion is disposed beyond the plug. The distal portion includes a helically wound wire and a tether coupled to the wire that is movable for causing the wire to buckle. To seal a passage communicating with a blood vessel, the distal portion of the locator member is inserted into the passage, and the plug is threaded into the passage until the distal portion extends into the vessel. The tether is pulled to buckle the wire, and the plug is unthreaded until the buckled wire contacts a wall of the vessel, whereupon the plug is released to seal the passage.

Claims

1. An apparatus for positioning a closure device within a passage, comprising:

an elongate member comprising a proximal end, a distal end, and a lumen extending between the proximal and distal ends defining a longitudinal axis;

a clip deliverable from the elongate member for sealing the passage; and

a selectively expandable locator member extending through the lumen, the locator member comprising a distal portion extending distally beyond the distal end of the elongate member, the distal portion comprising an elongate deflectable element comprising a helically wound wire extending between a proximal end and a distal end, and having an intermediate portion therebetween, and a control element fixedly connected to the distal portion of the deflectable element and extending along an outer surface of at least one coil of the helical wound wire and passing through at least one coil of the helical wound wire in a pre-deployed configuration, the control element extending from the distal portion to the proximal end of the expandable locator member and being movable axially to buckle an intermediate portion of the deflectable element substantially transversely with respect to the longitudinal axis.

2. The apparatus of claim 1, wherein the control element comprises a tether extending along an outer surface of at least the intermediate portion of the helically wound wire.

3. The apparatus of claim 2, wherein the intermediate portion of the deflectable element has a cross-section in its buckled configuration that is larger than a cross-section of the distal portion.

4. The apparatus of claim 1, further comprising an actuator on a proximal end of the elongate member, the actuator coupled to the locator member, the actuator configured for moving the control element proximally for buckling the intermediate portion of the deflectable element.

5. The apparatus of claim 1, wherein the elongate member and the selectively expandable locator member comprise cooperating detents for substantially securing the selectively expandable locator member axially with respect to the elongate member when the selectively expandable locator member is fully inserted into the elongate member.

6. The apparatus of claim 1, further comprising a housing slidably disposed on an exterior of the elongate member, the housing configured for releasably holding the clip, the housing being actuable for advancing the clip distally towards the distal end of the elongate member for deploying the clip.

7. An apparatus for delivering a closure element into a passage communicating with an opening into a body lumen, comprising:

an elongate member comprising proximal and distal ends and defining a longitudinal axis;

a housing slidably coupled to the elongate member, the housing configured for releasably holding a closure element, the closure element comprising a clip; and

a locator member coupled to the elongate member, the locator member having a distal portion extending distally beyond the distal end of the elongate member, the distal portion comprising helically wound wire comprising a proximal end, a distal end, and an intermediate portion therebetween, and a control element fixedly connected to the distal end of the helically wound wire, the control element extending from the distal portion to the proximal end of the expandable locator member and between a first pair of adjacent uniform coils of the helical wound wire and along an outer surface of at least one coil of the helical wound wire and passing between a second pair of adjacent uniform coils of the helical wound wire in a pre-deployed configuration and being movable axially to buckle the intermediate portion of the helically wound wire substantially transversely with respect to the longitudinal axis.

8. The apparatus of claim 7, wherein the control element comprises a tether extending along an outer surface of at least the intermediate portion of the helically wound wire.

9. The apparatus of claim 7, wherein the elongate member and the locator member include cooperating detents for substantially securing the locator member axially with respect to the elongate member.

10. The apparatus of claim 7, further comprising an actuator coupled to the housing, the actuator configured for advancing the housing distally to deploy the closure element therefrom.

11. The apparatus of claim 7, further comprising the closure element located within the housing.

12. The apparatus of claim 7, wherein at least a portion of the helically wound wire is configured to communicate with the body lumen.

13. An apparatus for positioning a closure device within a passage through tissue communicating with a body lumen, comprising:

an elongate member comprising a proximal end, a distal end, and a lumen extending between the proximal and distal ends defining a longitudinal axis;

a clip deliverable from the elongate member for sealing the passage; and

a locator member extending through the lumen, the locator member comprising a distal portion extending distally beyond the distal end of the elongate member, the distal portion comprising an elongate deflectable element comprising a proximal end and a distal end, and a control element fixedly connected to a distal portion of the deflectable element, the control element extending from the distal portion to the proximal end of the locator member and being moveable axially to buckle an intermediate portion of the deflectable element substantially transversely with respect to the longitudinal axis wherein the deflectable element comprises a helically wound wire extending between the proximal and distal ends of the deflectable element and having an intermediate portion therebetween, and wherein the control element comprises a tether extending along an outer surface of at least the intermediate portion of the helically wound wire in a pre-deployed configuration.

14. The apparatus of claim 13, wherein the intermediate portion of the deflectable element has a cross-section in its buckled configuration that is larger than a cross-section of the distal portion.

15. The apparatus of claim 13, further comprising an actuator on a proximal end of the elongate member, the actuator coupled to the locator member, the actuator configured for moving the control element proximally for buckling the intermediate portion of the deflectable element.

16. The apparatus of claim 13, wherein the elongate member and the locator member comprise cooperating detents for substantially securing the locator member axially with respect to the elongate member when the locator member is fully inserted into the elongate member.

17. The apparatus of claim 13, further comprising a housing slidably disposed on an exterior of the elongate member, the housing configured for releasably holding the clip, the housing being actuable for advancing the clip distally towards the distal end of the elongate member for deploying the clip.

18. The apparatus of claim 13, wherein at least a portion of the helically wound wire is configured to communicate with the body lumen.

19. A method for sealing a passage communicating with a body lumen using an elongate member comprising proximal and distal ends, and a closure element deployable from the distal end of the elongate member, the method comprising:

providing a selectively expandable locator member coupled to the elongate member such that a distal portion of the locator member extends distally beyond the distal end of the elongate member;

advancing the distal end of the elongate member through a patient'"'"'s skin towards the body lumen via the passage until the distal portion of the locator member is located within the body lumen;

moving a control element fixedly connected to a distal end of the deflectable element to buckle the deflectable element on the distal portion of the selectively expandable locator member from an axial collapsed configuration to a transverse expanded configuration, the deflectable element comprising a helically wound wire extending between a proximal end and a distal end and having an intermediate portion therebetween and the control element extending from the distal portion to the proximal end of the expandable locator member and extending along an outer surface of at least one coil of the helical wound wire and passing through at least one coil of the helical wound wire in a pre-deployed configuration;

manipulating the elongate member until the deflectable element in the expanded configuration contacts a proximal wall of the body lumen, thereby providing a tactile indication of a location of the distal end of the elongate member relative to the body lumen; and

deploying the closure element from the distal end of the elongate member within the passage, the closure element comprising a clip.

20. The method of claim 19, further comprising withdrawing the elongate member and the selectively expandable locator member from the passage, leaving the closure element to substantially close the opening.

21. The method of claim 19, wherein the elongate member comprises an introducer sheath, and wherein the method further comprises introducing one or more instruments through the lumen of the sheath into the body lumen prior to performing the steps of:

providing a selectively expandable locator member coupled to the elongate member such that the distal portion of the locator member extends distally beyond the distal end of the elongate member;

advancing the distal end of the elongate member through the patient'"'"'s skin towards the body lumen via the passage until the distal portion of the locator member is located within the body lumen;

buckling the deflectable element on the distal portion of the selectively expandable locator member from the axial collapsed configuration to the transverse expanded configuration, the deflectable element comprising a helically wound wire extending between the proximal end and the distal end;

manipulating the elongate member until the deflectable element in the expanded configuration contacts the proximal wall of the body lumen, thereby providing the tactile indication of the location of the distal end of the elongate member relative to the body lumen; and

deploying the closure element from the distal end of the elongate member within the passage.

22. The method of claim 21, further comprising performing a diagnostic or therapeutic procedure using the one or more instruments at a location accessed via the body lumen.

23. The method of claim 22, wherein the body lumen comprises a blood vessel, and wherein the procedure comprises at least one of angioplasty, atherectomy, stent delivering, delivery of a therapeutic agent, and tissue ablation.

24. The method of claim 19, wherein the deploying step comprises advancing a housing distally along an exterior of the elongate member, the housing having the closure element detachably held thereto.

25. The method of claim 24, wherein the housing is movable between a proximal position and a distal position, the distal position being a predetermined distance from the deflectable element in its expanded configuration.

26. The method of claim 19, wherein the control element comprises a tether extending along an outer surface of at least the intermediate portion of the helically wound wire.

27. The method of claim 19, wherein at least a portion of the helically wound wire communicates with the body lumen when the helically wound wire is in the transverse expanded configuration.

28. A method for sealing a passage communicating with a body lumen using a tubular member comprising proximal and distal ends and a lumen extending therebetween, and a closure element deployable from the distal end of the tubular member, the method comprising:

advancing the distal end of the tubular member through a patient'"'"'s skin into the passage towards the body lumen;

introducing a selectively expandable locator member into the lumen of the tubular member until a distal portion of the locator member extends beyond the distal end of the tubular member;

moving a control element fixedly connected to a distal portion of a deflectable element to buckle the deflectable element of the distal portion of the selectively expandable locator member from a collapsed configuration to a transversely expanded configuration within the body lumen, the deflectable element comprising a helically wound wire extending between a proximal end and a distal end and having an intermediate portion therebetween and the control element extending from the distal portion to the proximal end of the expandable locator member and extending along an outer surface of at least one coil of the helical wound wire and passing through at least one coil of the helical wound wire in a pre-deployed configuration;

manipulating the tubular member until the deflectable element in the expanded condition contacts a proximal wall of the body lumen, thereby providing a tactile indication of a location of the distal end of the tubular member relative to the body lumen; and

deploying the closure element from the distal end of the tubular member within the passage, the closure element comprising a clip.

29. The method of claim 28, wherein the selectively expandable locator member is introduced into the lumen of the tubular member before the distal end of the tubular member is advanced into the passage such that the distal portion of the selectively expandable locator member is advanced through the passage into the body lumen as the distal end of the tubular member is located into the passage.

30. The method of claim 28, wherein the selectively expandable locator member is introduced into the lumen of the tubular member after the distal end of the tubular member is advanced into the passage.

31. The method of claim 28, wherein the deploying step comprises advancing a housing distally along an exterior of the elongate member, the housing having the closure element detachably held thereto.

32. The method of claim 28, wherein the buckling step comprises directing the control element coupled to the distal end of the helically wound wire proximally, the control element comprising a tether extending along an outer surface of at least the intermediate portion of the helically wound wire.

33. The method of claim 28, wherein at least a portion of the helically wound wire communicates with the body lumen when the helically wound wire is in the transversely expanded configuration.

34. A method for sealing a passage communicating with a body lumen, the method comprising:

introducing a selectively expandable locator member into the passage until a distal portion of the selectively expandable locator member extends into the body lumen;

moving a control element fixedly connected to a distal portion of a deflectable element to buckle the deflectable element on the distal portion of the selectively expandable locator member from a collapsed configuration to a transversely expanded configuration within the body lumen, the deflectable element comprising a helically wound wire extending between a proximal end and a distal end and having an intermediate portion therebetween and the control element extending from the distal portion to the proximal end of the expandable locator member and extending along an outer surface of at least one coil of the helical wound wire and passing through at least one coil of the helical wound wire in a pre-deployed configuration;

manipulating the selectively expandable locator member until the deflectable element in the expanded condition contacts a proximal wall of the body lumen;

advancing a clip having tines which extend substantially axially and distally along the selectively expandable locator member until the clip is disposed at a predetermined location relative to the distal portion of the locator member;

returning the distal portion of the selectively expandable locator member from the expanded condition to the collapsed configuration; and

withdrawing the locator member from the passage, leaving the clip in the passage.

35. The method of claim 34, wherein the step of introducing the selectively expandable locator member comprises:

disposing a tubular member through a patient'"'"'s skin into the passage until a distal end of the tubular member is disposed proximate the body lumen;

introducing the selectively expandable locator member into a lumen of the tubular member until the distal portion of the locator member extends beyond the distal end of the tubular member into the body lumen.

36. The method of claim 35, further comprising withdrawing the tubular member from the passage before advancing the clip into the passage.

37. The method of claim 34, wherein the step of advancing the clip comprises advancing an elongate member having the clip thereon into the passage over the selectively expandable locator member, and wherein the method further comprises deploying the clip from the elongate member at the predetermined location.

38. The method of claim 37, wherein the selectively expandable locator member and the elongate member comprise cooperating elements for identifying when the closure device reaches the predetermined location.

39. The method of claim 38, wherein the cooperating elements comprise a marker on the selectively expandable locator member having a predetermined relationship with the distal portion of the selectively expandable locator member.

40. The method of claim 37, wherein the step of advancing the clip comprises advancing a housing along the elongate member until the clip reaches the predetermined location.

41. The method of claim 37, wherein the deflectable element is collapsed during the deployment step.

42. The method of claim 41, wherein the elongate member comprises a tubular member, and wherein the distal portion of the selectively expandable locator member is retracted into the lumen after the deflectable element is collapsed.

43. The method of claim 34, wherein the clip comprises a generally annular clip having tines which extend substantially axially and distally carried on an exterior of the elongate member, and wherein advancing a clip along the selectively expandable locator member until the clip is disposed at a predetermined location relative to the distal portion of the locator member further comprises advancing the clip towards the distal end of the elongate member until tines of the clip penetrate tissue adjacent the body lumen.

44. The method of claim 34, wherein the buckling step comprises directing the control element coupled to the distal end of the helically wound wire proximally, the control element comprising a tether extending along an outer surface of at least the intermediate portion of the helically wound wire.

45. The method of claim 34, wherein at least a portion of the helically wound wire communicates with the body lumen when the helically wound wire is in the transversely expanded configuration.

46. A method for sealing a passage communicating with a body lumen using an elongate member comprising proximal and distal ends, and a closure element deployable from the distal end of the elongate member, the method comprising:

coupling a locator member to the elongate member such that a distal portion of the locator member extend distally beyond the distal end of the elongate member;

advancing the distal end of the elongate member through a patient'"'"'s skin towards the body lumen via the passage until the distal portion of the locator member is located within the body lumen;

moving a control element fixedly connected to a distal portion of a deflectable element to buckle the deflectable element comprising a helically wound wire on the distal portion of the locator member from an axial collapsed configuration to a transverse expanded configuration, the helically wound wire extending between a proximal end and a distal end and having an intermediate portion therebetween and the control element extending from the distal portion to the proximal end of the locator member and extending along an outer surface of at least one coil of the helical wound wire and passing through at least one coil of the helical wound wire in a pre-deployed configuration;

manipulating the elongate member until the deflectable element in the expanded configuration contacts a proximal wall of the body lumen, thereby providing a tactile indication of a location of the distal end of the elongate member relative to the body lumen; and

deploying the closure element from the distal end of the elongate member within the passage, the closure element comprising a clip.

47. The method of claim 46, further comprising withdrawing the elongate member and the locator member from the passage, leaving the closure element to substantially close the passage.

48. The method of claim 46, wherein the elongate member comprises an introducer sheath, and wherein the method further comprises introducing one or more instruments through the lumen of the sheath into the body lumen.

49. The method of claim 48, further comprising performing a diagnostic or therapeutic procedure using the one or more instruments at a location accessed via the body lumen.

50. The method of claim 48, wherein the body lumen comprises a blood vessel, and wherein the procedure comprises at least one of angioplasty, atherectomy, stent delivery, delivery of a therapeutic agent, and tissue ablation.

51. The method of claim 46, wherein the deploying step comprises advancing a housing distally along an exterior of the elongate member, the housing having the closure element detachably held thereto.

52. The method of claim 51, wherein the housing is movable between a proximal position and a distal position, the distal position being a predetermined distance from the deflectable element in its expanded configuration.

53. The method of claim 46, wherein the control element comprises a tether extending along an outer surface of at least the intermediate portion of the helically wound wire.

54. The method of claim 46, wherein at least a portion of the helically wound wire communicates with the body lumen when the helically wound wire is in the transverse expanded configuration.