CLIP APPLIER AND METHODS OF USE

• US 20080312666A1
• Filed: 06/20/2008
• Published: 12/18/2008
• Est. Priority Date: 01/30/2003
• Status: Active Grant

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Original Assignee: Abbott Laboratories
• Inventors: Gross, T. Daniel, Voss, Laveille K., Ellingwood, Brian A., McCrystle, Kelly
• Granted Patent: US 8,202,293 B2
• Time in Patent Office: Days
• US Class Current: 606/142
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall

Abstract

An apparatus for delivering a closure element can include a splittable carrier tube and a splitter to split the tube. The carrier tube can have an outer surface retaining a closure element in a tubular configuration and can be split into radially-expandable flaps. A closure element has can have shape-memory body having a relaxed configuration with a planar-annular body defining a lumen with tines directed inwardly from the body. The clip can be held in a retaining configuration having a substantially asymmetrically-elongated tubular shape with a trapezoidal longitudinal cross-sectional profile and a proximal end having the tines being longitudinally directed with a first tine being more distally oriented compared to a substantially opposite second tine being more proximal, and retracting to a deploying configuration having a tubular shape with a rectangular longitudinal cross-sectional profile with the first tine being even with the second tine when being delivered.

Claims

1. An apparatus for delivering a closure element to an opening formed in a wall of a body lumen or body tissue, comprising:

carrier tube having an outer surface retaining said closure element in a substantially tubular configuration, the carrier tube having a lumen and at least one slit at a distal end of the carrier tube, and the carrier tube being configured to split at the slits so as to form outwardly bendable carrier flaps; and

a splitter disposed adjacent to the slits so that the splitter splits the carrier tube at the distal end to form and outwardly bend the carrier flaps.

2. An apparatus as in claim 1, wherein the splitter is disposed distally from the carrier tube and configured to move into the lumen with respect to the carrier tube to split the carrier tube into the carrier flaps, and the splitter has a proximal end with a cross-sectional profile smaller than a cross-sectional profile of the distal end of the carrier tube.

3. An apparatus as in claim 1, wherein the splitter is an expandable splitter that selectively expands to split the carrier tube to form and outwardly bend the carrier flaps.

4. An apparatus as in claim 1, further comprising:

a pusher tube having slits at a distal end and being configured to split into outwardly bendable pusher flaps by the splitter.

5. An apparatus as in claim 4, wherein the pusher tube is split by the splitter being moved oppositely with respect to said carrier tube to deploy said closure element over the outwardly bendable carrier flaps after expanding over the splitter.

6. An apparatus as in claim 5, wherein the splitter is an expandable splitter that selectively expands to split the pusher tube to form and outwardly bend the pusher flaps.

7. An apparatus as in claim 1, wherein the splitter is coupled to a support tube so as to form a splitter tube.

8. An apparatus as in claim 1, wherein the splitter is coupled to a wire disposed within the lumen of the carrier tube.

9. An apparatus as in claim 8, wherein the wire extends through a passage in the splitter and has an end with a retaining member disposed within a cavity in the splitter so that the end cannot pass through the passage.

10. An apparatus as in claim 1, wherein the splitter is comprised of a series of combinable splitters, wherein proximally disposed combinable splitters each have a recess for receiving a proximal portion of a distally-adjacent combinable splitter.

11. An apparatus as in claim 1, wherein the splitter is a tissue-grabbing splitter and includes at least one of teeth or barbs.

12. An apparatus for delivering a closure element to an opening formed in a wall of a body lumen or body tissue, comprising:

carrier tube having a total length and slits extending at least partially along said total length from a distal end, the slits being configured to split and separate a distal portion of the carrier tube into outwardly bendable carrier flaps, said carrier tube having an outer surface retaining a closure element in a substantially tubular configuration at the distal portion; and

a splitter disposed adjacent to the slits so that the splitter splits the carrier tube at the distal end to form and outwardly bend the carrier flaps.

13. An apparatus as in claim 12, wherein the splitter is disposed distally from the carrier tube and configured to move into the lumen with respect to the carrier tube to split the carrier tube into the carrier flaps, and the splitter has a proximal end with a cross-sectional profile smaller than a cross-sectional profile of the distal end of a lumen of the carrier tube and the splitter has a distal end with a cross-sectional profile larger than the cross-sectional profile of the distal end of the lumen of the carrier tube.

14. An apparatus as in claim 12, wherein the splitter is an expandable splitter that selectively expands to split the carrier tube to form and outwardly bend the carrier flaps.

15. An apparatus as in claim 12, wherein the splitter is coupled to support tube so as to form a splitter tube.

16. An apparatus as in claim 12, wherein the splitter is coupled to a wire disposed within the lumen of the carrier tube.

17. An apparatus as in claim 16, wherein the wire extends through a passage in the splitter and has an end with a retaining member disposed within a cavity in the splitter so that the end cannot pass through the passage.

18. An apparatus as in claim 12, wherein the splitter is comprised of at least a proximal combinable splitter and a distal combinable splitter, wherein the proximal combinable splitter has a recess for receiving a proximal end of the distal combinable splitter.

19. An apparatus as in claim 12, wherein the splitter is a tissue-grabbing splitter that includes at least one of teeth or barbs.

20. A method for closing an opening formed in a wall of a body lumen or body tissue, comprising:

positioning a carrier tube adjacent to the opening, the carrier tube having a distal end with an outer surface retaining a closure element in a substantially tubular configuration, said carrier tube having a lumen and being configured to split into carrier flaps;

splitting a distal end of the carrier tube with a splitter so as to form the carrier flaps that deform outwardly over the splitter; and

deploying said closure element from the outwardly deformed carrier flaps of the carrier tube and over the splitter so that said closure element engages at least a portion of said wall of said body lumen or said body tissue whereby said opening is drawn substantially closed.

21. A method as in claim 20, wherein the splitting is induced by at least one of the following:

moving the splitter distally with respect to the carrier tube;

moving the carrier tube proximally with respect to the splitter;

simultaneously moving the splitter proximally with respect to the carrier tube and moving the carrier tube distally with respect to the splitter;

expanding the splitter;

or

expanding a distal end of the splitter.

22. A method as in claim 20, further comprising:

grabbing tissue around the opening with barbs on the splitter; and

drawing the grabbed tissue toward the opening when the splitter is being pulled therethrough.

23. A clip for closing an opening formed in a wall of a body lumen or body tissue, the clip comprising:

a shape-memory clip having a relaxed configuration with a substantially annular body defining a lumen with a plurality of tines directed inwardly from the body, the clip being in a retaining configuration having a substantially asymmetrically-elongated tubular shape with a substantially trapezoidal longitudinal cross-sectional profile and a proximal portion having the plurality of tines being longitudinally and distally directed with a first tine of the plurality being more distally oriented compared to a substantially opposite second tine being more proximal when the clip is disposed in a clip applier, wherein the clip relaxes from the retaining configuration to the relaxed configuration when the clip is being released from the clip applier.

24. A clip as in claim 23, wherein the clip has a deploying configuration having a substantially tubular shape with a substantially rectangular longitudinal cross-sectional profile with the first tine being substantially even with the second tine, and wherein the clip relaxes from the retaining configuration to the deploying configuration before relaxing to the relaxed configuration when the clip is being released from the clip applier.

25. A clip as in claim 23, wherein the lumen in the retaining configuration has a smaller orthogonal cross-sectional profile compared to the lumen in the deploying configuration.

26. A clip as in claim 23, wherein the lumen in the retaining configuration has an oval orthogonal cross-sectional profile.

27. A clip as in claim 23, wherein the clip automatically retracts into the deploying configuration when being released from the clip applier.

28. A clip as in claim 27, wherein the clip automatically converts to the relaxed configuration from the deploying configuration after being released from the clip applier.

29. A clip as in claim 23, wherein the relaxed configuration is substantially planar or substantially curved so as to conform with the external surface of a blood vessel.

30. A clip as in claim 23, wherein the deploying configuration includes the first tine of the plurality being more distally oriented compared to a substantially opposite second tine being more proximal so that the deploying configuration is offset.

31. A clip as in claim 23, wherein the deploying configuration is substantially symmetrical.

32. A clip applier apparatus for delivering a clip to an opening formed in a wall of a body lumen or body tissue, the clip applier comprising:

a shape-memory clip being in a retaining configuration having a substantially asymmetrically-elongated tubular shape with a substantially trapezoidal longitudinal cross-sectional profile and a proximal end having a plurality of tines being longitudinally directed with a first tine of the plurality being more distally oriented compared to a substantially opposite second tine being more proximal when the clip is disposed in a clip applier;

a carrier tube having an outer surface configured for slidably retaining the clip in the retaining configuration and slidably delivering the clip in the deploying configuration.

33. A clip applier as in claim 32, further comprising:

a pusher tube being configured to distally push the clip in the retaining configuration over the carrier tube toward a distal end of the carrier tube.

34. A clip applier as in claim 33, further comprising:

the pusher tube being configured to distally push the clip over the distal end of the carrier tube so that the clip retracts to a deploying configuration having a substantially tubular shape with a substantially rectangular longitudinal cross-sectional profile with the first tine being substantially even with the second tine.

35. A clip applier as in claim 34, further comprising:

the pusher tube being configured to distally push the clip over the distal end of the carrier tube so that the clip retracts to a deploying configuration having a substantially symmetrical tubular shape with a substantially rectangular longitudinal cross-sectional profile with the first tine being substantially even with the second tine.

36. A clip applier as in claim 34, further comprising:

the pusher tube being configured to distally push the clip over the distal end of the carrier tube so that the clip retracts to a deploying configuration having a substantially offset tubular shape with a substantially offset longitudinal cross-sectional profile with the first tine being more distally oriented compared to a substantially opposite second tine being more proximal.

37. A clip applier as in claim 33, wherein a lumen of the clip in the retaining configuration has a smaller orthogonal cross-sectional profile compared to the lumen of the clip in a deploying configuration having a substantially tubular shape.

38. A clip applier as in claim 33, wherein a lumen of the clip in the retaining configuration has an oval orthogonal cross-sectional profile.

39. A clip applier as in claim 38, wherein the carrier tube has a corresponding substantially oval orthogonal cross-sectional profile.

40. A clip applier as in claim 33, further comprising a selectively expandable shape-memory clip expander configured to expand the clip during deploying.

41. A clip applier as in claim 40, wherein the clip expander is disposed at a distal portion of the carrier tube.

42. A clip applier as in claim 41, further comprising a cover tube defining a lumen retaining the clip in the retaining configuration and retaining the clip expander in a contracted orientation, the clip expander being capable of expanding when moved distally past a distal end of the cover tube.

43. A method for closing an opening formed in a wall of a body lumen or body tissue, the method comprising:

positioning a carrier tube adjacent to the opening, the carrier tube having a distal portion with an outer surface retaining a shape-memory clip in a retaining configuration having a substantially asymmetrically-elongated tubular shape with a substantially trapezoidal longitudinal cross-sectional profile and a proximal end having a plurality of tines being longitudinally directed with a first tine of the plurality being more distally oriented compared to a substantially opposite second tine being more proximal when the clip is disposed in a clip applier;

pushing the clip over a distal end of the carrier tube so that the clip retracts to a deploying configuration having a substantially tubular shape; and

ejecting the clip from the carrier tube so that at least a portion of the plurality of tines engage a portion of the wall of the body lumen or the body tissue whereby the opening is drawn substantially closed, wherein the clip relaxes from the deploying configuration to a relaxed configuration having a substantially annular body defining a lumen with a plurality of tines directed inwardly from the body.

44. A method as in claim 43, further comprising pushing the clip toward the distal end of the carrier tube with a pusher tube being configured to distally push the clip in the retaining configuration.

45. A method as in claim 43, further comprising relaxing the clip to a relaxed configuration with a substantially planar-annular body defining a lumen with a plurality of tines directed inwardly from the body of the clip, wherein at least a portion of the tines have inwardly drawn a portion of the wall of the body lumen or the body tissue so as to substantially close the opening.

46. A method as in claim 43, further comprising relaxing the clip to a relaxed configuration with a substantially curved annular body defining a lumen with a plurality of tines directed inwardly from the body of the clip, wherein at least a portion of the tines have inwardly drawn a portion of the wall of the body lumen or the body tissue so as to substantially close the opening and the curved annular body substantially conforms with the external surface of a blood vessel.

47. A method as in claim 43, further comprising expanding the clip from the retaining configuration having a lumen with a smaller orthogonal cross-sectional profile to the deploying configuration so that the lumen has a larger orthogonal cross-sectional profile.

48. A method as in claim 47, wherein the clip is expanded by a selectively expandable shape-memory clip expander.

49. A method as in claim 47, further comprising expanding the clip from the retaining configuration having a lumen with a more oval orthogonal cross-sectional profile to the deploying configuration so that the lumen has a more circular orthogonal cross-sectional profile.