Blood vessel closure clip and delivery device

• US 8,469,995 B2
• Filed: 06/04/2012
• Issued: 06/25/2013
• Est. Priority Date: 06/04/2002
• Status: Expired due to Fees

• Current Assignee: Abbott Vascular Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Vascular Incorporated (Abbott Laboratories Incorporated)
• Inventors: Cummins, Christy, Stevenson, Robert
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US13/488,233
• Publication Number:
  US 20120310261A1
• Time in Patent Office: 386 Days
• Field of Search: 606/151, 606/153, 606/157, 606/158, 606/213, 606/232, 606/142, 606/192, 606/194
• 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 17/064 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 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/22061 for spreading elements apart

Abstract

A clip for closing a puncture in a body lumen comprises a clip having a resiliently expandable circumference and a plurality of barbed prongs extending at least approximately in the same direction from one edge of the clip. A device for deploying such a clip is described. A method for deploying such a clip is also described.

Claims

1. A device for closing a puncture hole in a blood vessel, comprising:

an elongated body having a front end for insertion through the hole into the blood vessel;

a clip expander positioned on the body rearward of the front end, the clip expander comprising an inflatable balloon coaxially surrounding the elongated body and being in fluid communication with a port to allow inflation and deflation of the balloon, the balloon having a distal expandable region axially adjacent to an expandable proximal region, the distal expandable region having a first inflated diameter that is less than a second inflated diameter of the proximal expandable region, a transition between the first inflated diameter and the second inflated diameter forming a shoulder;

a clip mounted on the balloon and having a ring disposed around the balloon and prongs projecting towards the front end of the elongated body, the clip being mounted on the balloon with the shoulder disposed behind the ring, the ring being resiliently expandable with the balloon and the clip being advanceable into tissue surrounding the puncture hole with the shoulder preventing proximal movement of the clip upon distal movement of the elongated body.

2. The device of claim 1, wherein the proximal expandable region is made of a thicker material than the distal expandable region.

3. The device of claim 1, wherein the prongs converge slightly towards the center of the ring.

4. The device of claim 1, wherein the ring is sinuous.

5. The device of claim 1, wherein the ring comprises a plurality of elongated segments each with a longitudinal center slit, the segments being disposed side by side around the ring with their longitudinal axes substantially parallel and being joined each to the next by a relatively narrow waist.

6. The device of claim 1, wherein the body has a longitudinal bore to slidably accommodate a guide wire pre-positioned at the puncture hole.

7. The device of claim 1, wherein the body has a longitudinal bore to serve as a blood return channel.

8. A method for closing a puncture in a body lumen, the method comprising:

advancing a catheter until an indication that the catheter is positioned within a body lumen;

increasing a dimension of a clip expander to increase a dimension of a clip, the a clip expander comprising an inflatable balloon having a distal region axially adjacent to a proximal region, the proximal region forming a shoulder of greater diameter behind the adjacent distal region when the balloon is inflated,

the clip having a ring disposed around the inflatable balloon and having prongs projecting towards a front end of the catheter;

advancing the catheter to penetrate tissue surrounding the wall of the body lumen with the clip, wherein the shoulder allows the clip to be advanced with the catheter;

decreasing a dimension of the clip expander; and

removing the catheter from the tissue tract causing the clip to pull the surrounding tissue together substantially sealing the puncture.

9. The method of claim 8, wherein the proximal region of the balloon is made of a thicker material than the distal region.

10. The method of claim 8, wherein the indication that the catheter is positioned within a body lumen further comprises an indication of blood in a bleed back indicator.

11. The method of claim 8, wherein the increasing a dimension of the clip expander increases a dimension of the ring of the clip.

12. The method of claim 8, wherein advancing the catheter to cause the clip to penetrate tissue surrounding the wall of the body lumen is performed after increasing the dimension of the clip expander to increase a dimension of the clip.

13. The method of claim 8, wherein decreasing the dimension of the clip expander is performed after advancing the catheter to cause the clip to penetrate tissue surrounding the wall of the body lumen.

14. The method of claim 13, wherein the decreasing the dimension of the clip expander includes deflating the balloon.

15. A method for closing a puncture in a body lumen, the method comprising:

advancing a catheter, with a balloon, until an indication that a clip is positioned a pre-determined distance from a wall of the body lumen, the balloon having a distal region axially adjacent to a proximal region, the proximal region being made of a thicker material than the distal region, the distal region being expandable to a first inflation diameter less than a second inflation diameter of the adjacent proximal region, the distal region and the proximal region forming a shoulder configured to engage within the clip;

after advancing the catheter until the indication that the clip is positioned, inflating the balloon disposed around the catheter to increase a dimension of the clip, the distal region inflating to the first inflation diameter that is less than that of the second inflation diameter of the adjacent proximal region;

while the dimension of the clip expander is increased, advancing the catheter, with the shoulder disposed behind the clip and preventing proximal movement of the clip, to penetrate tissue surrounding the wall of the body lumen with the clip,

after advancing the catheter to penetrate tissue with the clip, deflating the balloon; and

removing the catheter from the tissue tract, the clip pulling the surrounding tissue together to substantially seal the puncture.