Apparatus and method for delivering a closure element

• US 8,926,633 B2
• Filed: 06/19/2006
• Issued: 01/06/2015
• Est. Priority Date: 06/24/2005
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Carly, Michael T.
• Primary Examiner(s): Houston, Elizabeth
• Application Number:
  US11/455,993
• Publication Number:
  US 20070021778A1
• Time in Patent Office: 3,123 Days
• Field of Search: 606/232, 606139-142, 606/151, 606157-158, 606191-195, 606/198
• US Class Current: 606/139
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

An apparatus for delivering and deploying a closure element to an opening formed in a body lumen, including a delivery assembly positionable through the tissue and into the opening. The delivery assembly includes a distal locator portion and a carrier portion oriented proximal to the distal locator portion. The distal locator portion is configured to selectably engage the body lumen adjacent to the opening, and the carrier portion is configured to carry and support the closure element in a substantially tubular configuration. The carrier portion is further configured to urge the closure element toward an expanded cross-sectional dimension for deployment thereof, such that the closure element is oriented to engage the tissue when deployed and, when released, to return to the natural, substantially planar configuration and the natural cross-section dimension wherein the engaged tissue is drawn substantially closed.

Claims

1. An apparatus for delivering and deploying a closure element to an opening formed in a body lumen, said apparatus comprising:

a closure element configured to resiliently deform between a natural, substantially planar configuration to a substantially tubular configuration, and further configured to substantially radially displace between a reduced substantially tubular configuration and an expanded substantially tubular configuration having a greater cross-sectional dimension; and

a delivery assembly positionable through said tissue and into said opening in the body lumen, and having a distal locator portion and a carrier portion oriented proximal to said distal locator portion, each of said distal locator portion and said carrier portion being supported by a support member and being selectively expandable to an expanded state and selectively contracted from said expanded state to an unexpanded state around the support member, a proximal end of the distal locator portion and a distal end of the carrier portion being fixed to an intermediate support region disposed at the distal end of the delivery assembly, said distal locator portion being configured to selectably engage said body lumen adjacent to said opening, and said carrier portion being configured to carry and support said closure element, in the reduced substantially tubular configuration with said carrier portion in said unexpanded state, and further configured to urge said closure element toward the expanded substantially tubular configuration for deployment thereof when said carrier portion is selectively expanded to said expanded state,

wherein said closure element is oriented to engage said tissue when deployed in the expanded substantially tubular configuration, and to return toward said natural, substantially planar configuration such that the engaged tissue is drawn substantially closed.

2. The apparatus of claim 1, further including:

a cover member protecting said delivery assembly such that at least said carrier portion and said closure element, in the reduced substantially tubular configuration, are fully contained therein, in a support configuration.

3. The apparatus of claim 2, wherein said cover member defines a lumen sized and dimensioned for relative axial sliding receipt of said delivery assembly therein from the support configuration to a predeployment configuration, exposing at least a distal portion of said closure element to enable radial expansion thereof by said carrier portion from the reduced substantially tubular configuration to the expanded substantially tubular configuration, for deployment thereof.

4. The apparatus of claim 3, wherein a distal portion of said cover member is biased and tapered radially inward.

5. The apparatus of claim 4, wherein said distal portion of said cover member includes a plurality of substantially resilient extension members tapered radially inward.

6. The apparatus of claim 5, wherein in said pre-deployment configuration, each extension member is configured to retain at least a proximal portion of the closure element against the carrier portion as said carrier portion is selectably moved from said unexpanded state to said expanded state urging said closure element from the reduced substantially tubular configuration to the expanded substantially tubular configuration, for deployment thereof.

7. The apparatus of claim 6, wherein said carrier portion includes one or more expansion elements configured to expand substantially transversely with respect to a longitudinal axis of the carrier portion to said expanded state.

8. The apparatus of claim 1, wherein said distal locator portion includes a distal obturator selectably controllable between an unexpanded state and an expanded state for engaging said body lumen.

9. The apparatus of claim 8, wherein

in said unexpanded state, said distal locator portion has a transverse cross-sectional dimension less than that of said opening, and

in said expanded state, said distal locator portion has a transverse cross-sectional dimension greater than or substantially equal to that of said opening.

10. The apparatus of claim 8, wherein said distal obturator includes one or more expansion elements configured to expand substantially transversely with respect to a longitudinal axis of the distal locator portion.

11. The apparatus of claim 8, further including:

a locator control system coupled to a proximal end region of said delivery assembly, said locator control system being configured to selectively control said distal locator portion between said expanded state and said unexpanded state.

12. The apparatus of claim 1, wherein

said carrier portion includes a proximal obturator selectably controllable between an unexpanded state and an expanded state urging said closure element from the reduced substantially tubular configuration to the expanded substantially tubular configuration, for deployment thereof.

13. The apparatus of claim 12, wherein said proximal obturator includes one or more expansion elements configured to expand substantially transversely with respect to a longitudinal axis of the carrier portion.

14. The apparatus of claim 13, further including:

a carrier control system coupled to a proximal end region of said delivery assembly, said carrier control system being configured to selectively control said carrier portion between said expanded state and said unexpanded state.

15. The apparatus of claim 2, further including:

a pusher member slideably disposed within said cover member, said pusher member including a contact end region configured to distally displace said closure member longitudinally along said delivery assembly.

16. The apparatus of claim 15, wherein said delivery assembly, said pusher member and said cover member are provided as a plurality of nested, telescoping members with a substantially common longitudinal axis.

17. The apparatus of claim 16, wherein

said contact end region of said pusher member includes one or more longitudinal extensions extending distally and being configured to expand radially as said distal end region of said pusher member moves distally and engages a distally-increasing transverse cross-sectional dimension of said closure element on said carrier portion.

18. The apparatus of claim 1, wherein said distal locator portion has a first transverse dimension and said carrier portion has a second transverse dimension, said first transverse dimension being greater than said second transverse dimension.

19. A system for closing an opening formed in a body lumen, comprising:

a superelastic closure element configured to resiliently deform between a natural, substantially planar configuration to a substantially tubular configuration, and further configured to substantially radially displace between a reduced substantially tubular configuration and an expanded substantially tubular configuration, having a greater cross-sectional dimension, said apparatus comprising;

a delivery assembly positionable through said tissue and into said opening in the body lumen, and having a distal locator portion and a carrier portion oriented proximal to said distal locator portion, each of said distal locator portion and said carrier portion being supported by a tubular member and being individually selectively expandable to an expanded state and selectively contracted from said expanded state to an unexpanded state through proximal and distal movement of respective control members extending longitudinally within a lumen of the tubular member, a proximal end of the distal locator portion being fixed relative to a distal end of the carrier portion by an intermediate support region, the proximal end of the distal locator portion and the distal end of the carrier portion being fixed to the intermediate support reach, each of the distal locator portion and the carrier portion including one or more expansion elements, said distal locator portion being configured to selectably engage said body lumen adjacent to said opening, and said carrier portion being disposed proximal to the distal locator portion by a fixed distance during insertion and deployment, said carrier portion being configured to carry and support said closure element, in the reduced substantially tubular configuration, and further configured to urge said closure element toward the expanded substantially tubular configuration for deployment thereof; and

a cover member protecting said delivery assembly such that at least said carrier portion and said closure element, in the reduced substantially tubular configuration, are fully contained therein, in a support configuration;

said carrier portion including a proximal obturator selectably controllable between said unexpanded state and said expanded state urging said closure element from the reduced substantially tubular configuration to the expanded substantially tubular configuration, for deployment thereof; and

a pusher member slideably disposed within said cover member, said pusher member including a contact end region configured to distally displace said closure element longitudinally along said delivery assembly, said contact end region of said pusher member including one or more longitudinal extensions extending distally and being configured to expand radially as said distal end region of said pusher member moves distally and engages a distally-increasing transverse cross-sectional dimension of said closure element on said carrier portion,

wherein said closure element is oriented to engage said tissue when deployed in the expanded substantially tubular configuration, and to return toward said natural, substantially planar configuration such that the engaged tissue is drawn substantially closed.

20. The system of claim 19, wherein said cover member defines a lumen sized and dimensioned for relative axial sliding receipt of said delivery assembly therein from the support configuration to a predeployment configuration, exposing at least a distal portion of said closure element to enable radial expansion thereof by said carrier portion from the reduced in the reduced substantially tubular configuration to the expanded substantially tubular configuration, for deployment thereof.

21. The system of claim 20, wherein said distal portion of said closure element includes two or more tines distally directed, in the substantially tubular condition.

22. The system of claim 21, wherein a distal portion of said cover member is biased and tapered radially inward.

23. The system of claim 22, wherein said distal portion of said cover member includes a plurality of substantially resilient extension members tapered radially inward.

24. The system of claim 23, wherein in said pre-deployment configuration, each extension member is configured to retain at least a proximal portion of the closure element against the carrier portion as said carrier portion is selectably moved from said unexpanded state to said expanded state, urging said closure element from the reduced substantially tubular configuration to the expanded substantially tubular configuration, for deployment thereof.

25. The system of claim 19, wherein said distal locator portion includes a distal obturator selectably controllable between said unexpanded state and said expanded state for engaging said body lumen.

26. The system of claim 25, wherein in said unexpanded state, said distal locator portion has a transverse cross-sectional dimension less than that of said opening, and in said expanded state, said distal locator portion has a transverse cross-sectional dimension greater than or substantially equal to that of said opening.

27. The system of claim 19, wherein said one or more expansion elements of said distal locator portion are configured to expand substantially transversely with respect to a longitudinal axis of the distal locator portion, and said one or more expansion elements of said carrier portion are configured to expand substantially transversely with respect to a longitudinal axis of the carrier portion.

28. The system of claim 27, further including:

a locator control system coupled to a proximal end region of said delivery assembly, said locator control system being configured to selectively control said distal locator portion between said expanded state and said unexpanded state; and

a carrier control system coupled to a proximal end region of said delivery assembly, said carrier control system being configured to selectively control said carrier portion between said expanded state and said unexpanded state.

29. A method for closing an opening formed in a body lumen, comprising:

extending a distal end region of a distal locator portion of a delivery apparatus through tissue into the opening in the body lumen;

engaging said body lumen adjacent to said opening;

positioning a carrier portion of the delivery apparatus through said tissue adjacent to said opening, said carrier portion being oriented proximal to said distal locator portion, a proximal end of said distal locator portion and a distal end of said carrier portion being fixed to an intermediate support region disposed at a distal end of the delivery assembly, each of said distal locator portion and said carrier portion being supported by a support member and being selectively expandable to an expanded state and selectively contracted from the expanded state to an unexpanded state around said support member, said carrier portion, in an unexpanded state being configured to support a closure element that resiliently deforms between, a natural, substantially planar configuration to a substantially tubular configuration;

radially expanding the closure element from the reduced, substantially tubular configuration to an expanded, substantially tubular configuration, via the carrier portion; and

urging said closure element toward the expanded substantially tubular configuration with said carrier portion when said carrier portion is selectively expanded to said expanded state;

distally deploying said closure element from said carrier portion such that said closure element substantially uniformly expands to a cross-section that is greater than a natural cross-section of said closure element, engages said tissue, and returns to said natural, planar configuration and said natural cross-section such that said tissue is drawn substantially closed.