Apparatus and methods for delivering a vascular closure device to a body lumen

• US 6,780,197 B2
• Filed: 12/07/2000
• Issued: 08/24/2004
• Est. Priority Date: 01/05/2000
• Status: Expired due to Term

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated), Medical Technology Incorporated
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Roe, Steven N., Belef, W. Martin, Ginn, Richard S.
• Primary Examiner(s): ODLAND, KATHRYN P
• Application Number:
  US09/732,835
• Publication Number:
  US 20020026208A1
• Time in Patent Office: 1,356 Days
• Field of Search: 606/213, 606/139, 606/142, 606/144, 606/148, 606/214, 606/219, 227/175.1, 227/179.1
• 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 2017/00637 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 2017/00668 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 34/76 Manipulators having means for providing feel, e.g. force or tactile feedback

Abstract

An apparatus for delivering a closure element into a puncture communicating with a blood vessel includes an introducer sheath, and a locator member disposed within the sheath, the locator member having a distal portion extending distally beyond the distal end of the sheath. A plurality of splines are provided on the distal portion of the locator member, the splines being selectively expandable between an axial collapsed configuration and a transverse expanded configuration. An actuator is coupled to the locator member for controllably expanding the splines. A housing is slidably disposed on the sheath for deploying a closure element, such as a vascular clip. The locator actuator may automatically collapse the splines upon advancement of the housing.

Claims

1. 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;

an annular clip carried by the elongate member for closing the opening;

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;

one or more positioning elements on the distal portion of the locator member, the positioning elements being selectively expandable between a substantially axial collapsed configuration and a substantially transverse expanded configuration; and

a housing slidably disposed on the exterior of the elongate member, the housing configured for housing the clip and releasably holding the clip therein, the housing being actuable for advancing the clip distally towards the distal end of the elongate member.

2. The apparatus of claim 1, wherein the positioning elements comprise splines configured for expanding substantially transversely with respect to a longitudinal axis of the elongate member.

3. The apparatus of claim 2, wherein the one or more positioning elements comprise a plurality of substantially flexible splines.

4. The apparatus of claim 2, wherein the one or more positioning elements comprise a pair of splines disposed opposite one another about the distal portion.

5. The apparatus of claim 2, wherein each spline has a first fixed end and a second movable end, the second end being axially movable towards the first end to cause an intermediate region of the spline to expand transversely outward, thereby defining the substantially transverse expanded configuration.

6. The apparatus of claim 5, wherein the locator member comprises a control member having a distal end coupled to the second end of each spline, the control member being movable axially with respect to the elongate member to selectively expand the splines between the collapsed configuration and the expanded configuration.

7. The apparatus of claim 1, further comprising an actuator coupled to the locator member, the actuator configured for selectively expanding the positioning elements from the collapsed configuration to the expanded configuration.

8. The apparatus of claim 7, wherein the actuator is configured for selectively expanding the positioning elements to one of a plurality of expanded diameters.

9. The apparatus of claim 7, wherein the actuator is configured for selectively expanding the positioning elements to a desired angle with respect to a longitudinal axis of the locator member.

10. The apparatus of claim 9, wherein opposing positioning elements may be expanded to complementary angles with respect to the longitudinal axis.

11. The apparatus of claim 1, further comprising an actuator coupled to the housing, the actuator configured for advancing the housing distally to deploy the clip therefrom.

12. The apparatus of claim 11, wherein the actuator is further configured for automatically collapsing the positioning elements to the collapsed configuration upon advancement of the housing.

13. The apparatus of claim 11, further comprising a spring mechanism for biasing the housing distally upon activation of the actuator.

14. The apparatus of claim 1, wherein the elongate member comprises an introducer sheath including a lumen therethrough, and wherein the locator member is removably insertable into the lumen, the distal portion of the locator member having a size for insertion through the lumen when the positioning members are in the collapsed configuration.

15. The apparatus of claim 14, wherein the sheath and the locator member include cooperating detents for substantially securing the locator member axially with respect to the sheath when the locator member is fully inserted into the sheath.

16. The apparatus of claim 14, wherein the locator member comprises a substantially rigid sleeve extending beyond the distal end of the sheath, the positioning elements being deployable axially from within the sleeve.

17. An apparatus for delivering an annular clip into a passage communicating with an opening into a body lumen, comprising:

an elongate member comprising proximal and distal ends;

a housing slidable along an exterior of the elongate member, the housing configured for releasably holding annular clip therein;

a locator member comprising a distal portion extending distally beyond the distal end of the elongate member; and

one or more positioning elements on the distal portion of the locator member, the positioning elements being selectively expandable between a substantially axial collapsed configuration and a substantially transverse expanded configuration.

18. The apparatus of claim 17, wherein the elongate member and the locator member include cooperating detents for substantially securing the locator member axially with respect to the elongate member.

19. The apparatus of claim 17, further comprising an actuator coupled to the housing, the actuator configured for advancing the housing distally to deploy an annular clip therefrom.

20. The apparatus of claim 19, wherein the actuator is further configured for automatically collapsing the positioning elements to the collapsed configuration upon advancement of the housing.

21. The apparatus of claim 19, further comprising a spring mechanism for biasing the housing distally upon activating the actuator.

22. The apparatus of claim 17, wherein each positioning element comprises a spline having a first fixed end and a second movable end, the second end being axially movable towards the first end to cause an intermediate region of the spline to expand transversely outward, thereby defining the substantially transverse expanded configuration.

23. The apparatus of claim 17, further comprising an actuator coupled to the locator member, the actuator configured for selectively expanding the positioning elements from the collapsed configuration to the expanded configuration.

24. The apparatus of claim 23, wherein the actuator is configured for selectively expanding the positioning elements to one of a plurality of expanded diameters.

25. The apparatus of claim 17, wherein the elongate member comprises an introducer sheath, and wherein the locator member is insertable into a lumen of the sheath.

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

a tubular member comprising proximal and distal ends;

an annular housing overlying the tubular member and slidable towards the distal end of the tubular member;

an annular clip releasably carried within the housing; and

a locator member within the tubular member, the locator member having a distal portion extending distally beyond the distal end of the tubular member, the distal portion comprising a plurality of positioning elements, the positioning elements being selectively expandable between a substantially axial collapsed configuration and a substantially transverse expanded configuration.

27. The apparatus of claim 26, wherein the locator member is insertable into the tubular member, the locator member and tubular member comprising cooperating detents for substantially securing the locator member with respect to the tubular member.

28. The apparatus of claim 26, further comprising an actuator coupled to the housing for advancing the housing and the closure element therein towards the distal end of the tubular member for deploying the closure element from the housing.

29. The apparatus of claim 28, wherein the actuator is configured for automatically collapsing the positioning elements when the housing reaches a distal position for deploying the closure element.

30. The apparatus of claim 29, wherein the actuator is configured for retracting the positioning elements into the tubular member when the closure element is deployed from the housing.

31. A method for delivering a closure element into a passage communicating with an opening in a wall of a body lumen, the method comprising:

positioning an elongate member through a patient'"'"'s skin towards the body lumen via the passage, the elongate member including a lumen extending between its proximal and distal ends; and

providing a locator comprising a distal portion extending beyond the distal end of the elongate member and into the body lumen;

expanding one or more positioning elements on the distal portion of the locator from a collapsed configuration to an expanded configuration;

withdrawing the elongate member and locator partially until the positioning elements in their expanded configuration contact the wall of the body lumen, thereby providing a tactile indication of a location of the distal end of the elongate member; and

delivering a clip located in a housing slidably mounted on the elongate member via the elongate member into the passage by advancing the housing distally along the exterior of the elongate member, the housing releasably holding the clip therein.

32. The method of claim 31, further comprising withdrawing the elongate member and locator from the body lumen and opening, leaving the clip to substantially close the opening.

33. The method of claim 31, 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.

34. The method of claim 33, further comprising performing a diagnostic or therapeutic procedure using the one or more instruments at a location accessed via the body lumen.

35. The method of claim 34, 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.

36. The method of claim 31, wherein the elongate member comprises a tubular body, wherein the locator is inserted into the tubular body and is axially fixed with respect to the tubular body when the locator is fully inserted into the tubular body.

37. The method of claim 31, wherein the housing is movable between a proximal position and a distal position, the distal position being a predetermined distance from the positioning elements in their expanded configuration.

38. The method of claim 37, wherein the positioning elements automatically return to the collapsed configuration when the housing is advanced to the distal position.

39. The method of claim 31, further comprising collapsing the one or more positioning elements to the collapsed configuration before withdrawing the elongate member and locator.

40. The method of claim 31, wherein the housing comprising a cavity carrying the clip therein, and wherein the delivering step comprises deploying the clip from the cavity.

41. The method of claim 31, wherein the one or more positioning elements comprise a pair of opposing splines on the distal portion, the splines being expandable from a substantially axial collapsed configuration to a substantially transverse expanded configuration.