Apparatus and method for delivering a closure element

• US 8,758,398 B2
• Filed: 09/07/2007
• Issued: 06/24/2014
• Est. Priority Date: 09/08/2006
• Status: Expired due to Fees

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Inventors: Carley, Michael T.
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US11/852,190
• Publication Number:
  US 20080065152A1
• Time in Patent Office: 2,482 Days
• Field of Search: 606/232, 606/153, 606/213, 606/151, 606/142, 606/139, 606/143, 606/216, 606/215
• 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 17/0644 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 2017/0649 Coils or spirals

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 assembly 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 assembly is configured to carry and support the closure element in a substantially tubular configuration. The carrier assembly 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. A closure system for closing an opening formed in a body lumen perimeterically defined by opposing arterial walls, said system comprising:

a closure element adapted to deform from a natural, substantially resilient planar configuration to a substantially tubular configuration, having a substantially natural transverse cross-sectional dimension;

a delivery assembly positionable through said tissue and into the opening in the body lumen, and having an elongated body, a carrier assembly and a distal tissue engaging device, said carrier assembly configured to be slidably received in a lumen of an introducer sheath, said carrier assembly including a carrier seat configured to carry and peripherally support said closure element in the substantially tubular configuration, in a first diameter, and said distal tissue engaging device selectably axially displaceable relative to said carrier seat between an engaging condition, in which said distal tissue engaging device is configured to engage the opposing arterial walls of said body lumen adjacent to said opening, and a closing condition, in which said distal tissue engaging device is configured to urge the engaged opposing arterial walls substantially transversely together such that the closure element can be deployed from the carrier assembly, while substantially maintained in the first diameter, into the opposing arterial walls, said distal tissue engaging device including two or more opposed engaging tongs having respective tips, said two or more tongs being configured to resiliently move radially outwardly from a longitudinal axis of the carrier assembly to extend said respective tips outwardly beyond an outer diameter of the carrier seat, wherein the tissue engaging device is configured to cooperate with the introducer sheath to enable movement of said two or more tongs between the engaging condition, with said two or more tongs resiliently moving radially outwardly to the engaging condition, and the closing condition and the closure element being configured to be deployed between said two or more tongs; and

a pusher member slidably disposed about said elongated body for relative axial sliding displacement therebetween, said pusher member having a contact portion disposed proximally adjacent the closure element to selectively distally deploy said closure element from said carrier assembly, in the substantially tubular configuration, to engage said opposing arterial walls and to return to said natural, substantially planar configuration and said natural, transverse cross-sectional dimension such that the engaged opposing arterial walls are drawn substantially closed.

2. The apparatus of claim 1, wherein said two or more opposed engaging tongs having respective end tips are configured to open radially in directions extending beyond the outer diameter to initially engage the opposing portions of the arterial wall, in the engaging condition.

3. The apparatus of claim 1, wherein said carrier assembly having a cover member, said cover member being configured to protect at least said closure element which is contained therein.

4. The apparatus of claim 3, wherein said distal tissue engaging device is integral with a distal end of said cover member.

5. The apparatus of claim 1, wherein said carrier assembly is formed and dimensioned for sliding axial, reciprocating, receipt in a lumen of the introducer sheath extending through said tissue and terminating proximate the opening, wherein distal retraction of the introducer sheath exposes said two or more tongs to allow the tips to extend to the tissue engaging position and distal sliding of the introducer sheath moves said two or more tongs to the closing condition.

6. The apparatus of claim 1, further comprising a locator to position the carrier assembly and distal tissue engaging device adjacent to the opening in the body lumen, the locator having a distal locator portion selectably controllable between an unexpanded state and an expanded state for engaging the opposing portions of the arterial wall of said body lumen.

7. The apparatus of claim 1, further including a distal tissue locator portion contained on said delivery assembly, and configured to facilitate detection of the body lumen, said distal locator portion including one or more expansion elements configured to expand substantially transversely with respect to a longitudinal axis of the distal locator portion.

8. The apparatus of claim 7, wherein said distal locator portion is selectably controllable between an unexpanded state and an expanded state for engaging said opposing arterial walls of 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 closure system of claim 1, wherein said pusher member comprises one or more distally extending longitudinal extensions.

11. The closure system of claim 1, further comprising a locator slidably receivable within said pusher member and said delivery assembly.