Clip applier and methods of use

• US 9,271,707 B2
• Filed: 03/08/2013
• Issued: 03/01/2016
• Est. Priority Date: 01/30/2003
• Status: Active Grant

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Palermo, Thomas J., Belef, William M., Carley, Michael T., Ginn, Richard S., Pantages, Anthony J., Jabba, Ronald J., Ellingwood, Brian A., Voss, Laveille Kao, McCrystle, Kelly J., Gross, T. Daniel, Kokish, Arkady
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/791,846
• Publication Number:
  US 20130190778A1
• Time in Patent Office: 1,089 Days
• 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 17/064 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 2017/0003 of parts of the instruments
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• 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 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/12018 Elastic band ligators
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure

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 can have a 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. A vessel closure device delivery system for closing an opening formed in a wall of a body lumen or body tissue, comprising:

a delivery device that couples to a vessel closure clip for delivering the clip onto a blood vessel, the delivery device having a proximal end, a distal end and a lumen extending therethrough;

a vessel locator selectively deployable from the delivery device, the vessel locator having a proximal portion and a distal end portion forming an anchor loop, the anchor loop adapted to transition between a collapsed state while positioned within the delivery device that is suitable for insertion into a vessel and an expanded state when deployed from delivery device that lodges against a wall of the vessel from inside the vessel; and

a vessel closure clip,

wherein the delivery device is configured to position the vessel closure clip adjacent to the opening from outside the vessel and to distally deploy the vessel closure clip into tissue surrounding the opening of the body lumen such that the body lumen is drawn substantially closed, and

wherein the anchor loop is selectively detachable from the proximal portion of the vessel locator and cooperates with the vessel closure clip to retain the opening in a substantially closed position.

2. A system as in claim 1, wherein the delivery device comprises a clip carrier assembly, the clip carrier assembly comprising an elongated member retaining the vessel closure clip in a deliverable configuration, a pusher member adapted to deploy the vessel closure clip, and an actuator to actuate the pusher member with respect to the elongated member to deploy the clip.

3. A system as in claim 2, wherein the carrier assembly further comprises a cover member for retaining the vessel closure clip on the elongated member during delivery, the cover member coupled to an actuator to release the clip during deployment.

4. A system as in claim 1, wherein the vessel locator is part of a locating device sized and constructed to function as a guidewire in the collapsed state, and wherein the locating device may be used to guide the delivery device to the vessel wall.

5. A system as in claim 4, wherein the delivery device may be removed from the locating device so that the locating device can be used to deliver a procedural sheath.

6. A system as in claim 1, wherein the vessel locator comprises a wire and wherein the anchor loop is biased in the expanded state.

7. A system as in claim 6, wherein the vessel closure clip comprises a plurality of tines that, following deployment of the vessel closure clip, extend through the wall of the body lumen and capture at least a portion of the detachable anchor loop.

8. A system as in claim 7 further comprising:

an anchor sheath having a proximal end, a distal end and a lumen extending therethrough; and

a pusher member having a proximal end and a distal end, a proximal end of the wire being coupled to the distal end of the pusher member, and the pusher member being positioned within the lumen of the anchor sheath and being axially slideable relative to the anchor sheath to selectively transition the vessel locator between the collapsed state and the expanded state.

9. A system as in claim 8, wherein the distal end portion of the wire is configured to selectively decouple the anchor loop from the pusher member following deployment of the anchor loop.

10. A system as in claim 9, wherein the anchor loop is made of a biocompatible, implantable metal or plastic.

11. A system as in claim 9, wherein the anchor loop is made of a biocompatible, dissolvable or degradable material.

12. A system as in claim 8, wherein the delivery device, the anchor sheath, and the pusher member are slidably coupled as a plurality of nested, telescoping members with a common longitudinal axis.

13. A system as in claim 6, wherein the distal end portion of the wire is made from a shape memory material.

14. A system as in claim 6, wherein a portion of the vessel locator is substantially axially aligned with, and at least partially slidably disposable within, the lumen of the delivery device.

15. A system as in claim 6, wherein the delivery device comprises a carrier assembly having a carrier member for retaining said vessel closure clip in a substantially tubular configuration within the carrier assembly, and a pusher member adapted to deploy the closure element.

16. A system as in claim 6, further comprising an expandable hemostasis member configured to conform to an outer wall of the body lumen so as to create hemostasis across the opening while the vessel locator is in an expanded state and positioned against a wall of the vessel from inside the vessel.

17. A system for delivering a closure element to an opening formed in a wall of a body lumen or body tissue, comprising:

a locator assembly having a distal end region and a locator control system coupled to a proximal end region of said locator assembly, said locator control system being configured to selectively control said distal end region of said locator assembly between an unexpanded state and an expanded state for engaging said wall of said body lumen or said body tissue adjacent to said opening, the distal end region of said locator assembly being selectively detachable;

from said proximal end region of said locator assembly and

a carrier assembly coupled with said locator assembly, said carrier assembly comprising a carrier member for retaining said closure element in a substantially tubular configuration within said carrier assembly, and a pusher member adapted to deploy said closure element.

18. The system of claim 17, wherein said distal end region of said locator assembly includes an expansion element configured to expand substantially transversely with respect to a longitudinal axis of the locator assembly.

19. The apparatus of claim 18, wherein said expansion element comprises a wire, at least a distal portion of which is biased to form an anchor loop in the expanded state.

20. A system for delivering a closure element to an opening formed in a wall of a body lumen or body tissue, comprising:

a closure element having a plurality of tissue piercing tines for engaging body tissue adjacent the opening;

a locator assembly comprising

an anchor sheath having a proximal end, a distal end and a lumen extending therethrough;

a pusher member having a proximal end and a distal end, the pusher member slidably positioned within the lumen of the anchor sheath;

a wire having a proximal end and a distal portion, the proximal end of the wire being coupled to the distal end of the pusher member and the distal portion of the wire being configured to extend through tissue into the opening and expand to selectively engage an internal surface of the body lumen adjacent to the opening so as to provide a desired position of the system relative to the body lumen; and

a carrier assembly being slidably associated with the locator, the carrier assembly having a carrier member supporting the closure element and a cover member retaining the closure element within the carrier assembly, the carrier assembly being configured to position the closure element adjacent to the opening and being configured to distally deploy the closure element into tissue surrounding the opening of the body lumen such that the body lumen is drawn substantially closed,

wherein the distal portion of the wire is selectively detachable from the proximal end of the wire after deployment within the body lumen and cooperates with the closure element to retain the opening in a substantially closed position.