Closure devices, systems, and methods

• US 9,173,644 B2
• Filed: 01/08/2010
• Issued: 11/03/2015
• Est. Priority Date: 01/09/2009
• Status: Active Grant

• Current Assignee: Abbott Vascular Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Vascular Incorporated (Abbott Laboratories Incorporated)
• Inventors: Voss, Laveille K.
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US12/684,400
• Publication Number:
  US 20100179571A1
• Time in Patent Office: 2,125 Days
• Field of Search: 606/142, 606/151, 606/157, 606/158, 606/213, 606/215, 606/216, 606219-221
• US Class Current: 1/1
• 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 17/068 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 2017/00659 located only on one side 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0645 being elastically deformed for insertion

Abstract

The present disclosure includes vessel closure devices, systems, and methods. A closure system configured to close a body lumen opening may include a handle member. A tube set configured to deliver and/or deploy a closure element may be coupled to the handle member. The closure system may also include an inner lumen with an anchor member at least partially disposed in the inner lumen. A plunger member may be movably coupled to the handle member.

Claims

1. A closure system comprising:

a handle member;

a tube set configured to deliver or deploy a closure element, the tube set having a distal end and a proximal end, the proximal end of the tube set being coupled to the handle member;

an inner lumen disposed at least partially within the tube set;

a plunger member movably coupled to the handle member; and

an anchor member at least partially disposed within the inner lumen, the anchor member comprising an anchor portion, a first elongate portion, and a second elongate portion, the anchor portion being disposed in the inner lumen in an initial configuration and configured to move to an expanded configuration in a transverse plane to said elongate portion once deployed from the inner lumen without additional external force, the expanded configuration including a first portion and a second portion, the second portion being an inverted mirror image of the first portion about an intersection between the first portion and the second portion, the first elongate portion, the second elongate portion, the first portion, and the inverted second portion are continuously connected the anchor member configured to locate the closure system within a body lumen, the anchor member being configured to be retracted through the closure element.

2. The closure system of claim 1, the plunger member being longitudinally slidable with respect to the handle member.

3. The closure system of claim 1, the closure element disposed within the tube set in an initial configuration and being configured to move to a deployed configuration once deployed from the tube set.

4. The closure system of claim 1, the plunger member being at least partially disposed within a recess in the handle member.

5. The closure system of claim 1, the inner lumen being movable relative to the tube set and handle member.

6. The closure system of claim 1, the anchor member comprising shape memory or superelastic materials.

7. The closure system of claim 6, the anchor portion further comprising an elongate wire forming the elongate portion and the anchor portion.

8. The closure system of claim 6, wherein the first or second elongate portion of the anchor member is coupled to the plunger member.

9. The closure system of claim 8, wherein the plunger member is configured to slide in a distal direction relative to the handle member to deploy and expand the anchor portion of the anchor member from the initial configuration to the expanded configuration.

10. The closure system of claim 9, wherein the handle member is configured to move in a distal direction relative to the plunger member to advance the distal end of the tube set to proximity with the anchor portion of the anchor member.

11. The closure system of claim 1, the expanded configuration of the anchor portion comprising a plurality of projections laying in a plane that is transverse to a longitudinal axis of the elongate portion of the anchor member.

12. The closure system of claim 11, wherein at least one of the projections is shaped similar to a petal or leaf.

13. The closure system of claim 12, wherein the expanded configuration of the anchor portion is substantially similar in shape to a four-leaf clover, figure eight, a ball, or a configuration having more than four leaves.

14. The closure system of claim 1, further comprising the handle member or tube set being configured to deploy the closure element from the distal end of the tube set.

15. The closure system of claim 1, the closure element comprising a clip or staple.

16. The closure system of claim 1, the handle member further comprising one or more indentations or flanges configured to facilitate gripping or manipulating the handle member.

17. The closure system of claim 1, wherein the tube set comprises a garage tube, a pusher tube, and a carrier tube.

18. A closure system comprising:

a handle member;

a tube set including one or more tubular members configured to contain, deliver or deploy a closure element, the tube set having a distal end and a proximal end, the proximal end of the tube set being coupled to the handle member, wherein the closure element is disposed within the tube set in an open configuration;

an inner lumen disposed at least partially within the tube set;

a plunger member movably coupled to the handle member; and

an anchor member at least partially disposed within the inner lumen, the anchor member comprising a first elongated portion, a second elongated portion, and an anchor portion with at least two looped portions, the first elongated portion, the second elongated portion, and the anchor member, with the at least two looped portions, being continuously connected from the first elongated portion to the second elongated portion, the anchor portion being disposed in the inner lumen in an initial configuration and configured to move to an expanded configuration once deployed from within the inner lumen without additional external force, wherein distal movement of the plunger member deploys the anchor member to the expanded configuration and proximal movement of the plunger member retracts the anchor member back to the initial configuration, the expanded configuration including a first portion and a second portion, the second portion being an inverted mirror image of the first portion about an intersection between the first portion and the second portion the anchor member configured to locate the closure system within a body lumen, the anchor member being configured to be retracted through the closure element.

19. The closure system of claim 18, the inner lumen being movable relative to the tube set and handle member and the anchor member comprising shape memory or superelastic materials.

20. The closure system of claim 18, the anchor portion further comprising an elongate wire forming the first and second elongate portions and the anchor portion.

21. The closure system of claim 18, wherein the first and second elongate portions of the anchor member are coupled to the plunger member.

22. The closure system of claim 18, wherein the one or more tubular members comprise a garage tube, a pusher tube, and a carrier tube.

23. A method of closing a body lumen opening having a lumen wall comprising:

advancing a closure system at least partially into a body lumen opening, the closure system comprising;

a handle member;

a tube set configured to deliver or deploy a closure element, the tube set having a distal end and a proximal end, the proximal end of the tube set being coupled to the handle member;

an inner lumen disposed at least partially within the tube set;

a plunger member movably coupled to the handle member; and

an anchor member at least partially disposed within the inner lumen, the anchor member comprising an anchor portion having at least two looped portions and a pair of elongate portions, the anchor portion, with the at least two looped portions, and the pair of elongate portions being continuously connected together, the anchor portion being disposed in the inner lumen in an initial configuration and configured to move to an expanded configuration in a transverse plane to said first elongate portion and said second elongate portion once deployed from the inner lumen without external force, the expanded configuration including a first portion and a second portion, the second portion being an inverted mirror image of the first portion about an intersection between the first portion and the second portion, the first elongate portion, the second elongate portion, the first portion, and the inverted second portion are continuously connected the anchor member configured to locate the closure system within the body lumen, the anchor member being configured to be retracted through the closure element;

deploying the anchor portion of the anchor member within the body lumen;

positioning the anchor portion of the anchor member against a distal surface of the lumen wall proximate the body lumen opening;

advancing the tube set in a distal direction to position the distal end of the tube set against a proximal surface of the lumen wall proximate the body lumen opening; and

deploying a closure element into the lumen wall proximate the body lumen opening to close the body lumen opening.

24. The method of claim 23, further comprising advancing the plunger member to deploy the anchor portion of the anchor member and retracting the plunger member to retract the anchor portion of the anchor member.