Occlusion member and tensioner apparatus and methods of their use for sealing a vascular puncture

• US 7,316,704 B2
• Filed: 03/22/2004
• Issued: 01/08/2008
• Est. Priority Date: 06/04/2003
• Status: Expired due to Fees

• Current Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Original Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Inventors: Khosravi, Farhad, Pai, Suresh S., Domingo, Nicanor, Domingo, Juan, Bagaoisan, Celso J.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/806,927
• Publication Number:
  US 20040267307A1
• Time in Patent Office: 1,387 Days
• Field of Search: 606/157, 606/213, 606/214, 606/220, 606/228, 606/229, 606/192, 606/193, 606/144, 606/148
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation

Abstract

Apparatus for sealing a puncture includes an elongate occlusion member having a balloon attached to distal ends of telescoping inner and outer members. A housing on the proximal end of the outer member includes a piston coupled to the inner member and slidable within a chamber communicating with a fluid reservoir. A switch on the housing is actuated to direct fluid from the reservoir through the outer member into the balloon to expand the balloon and into the chamber to move the piston and pull the inner member, shortening the balloon as it expands. During use, the distal end of the occlusion member is introduced into a puncture communicating with a vessel until the collapsed balloon is disposed within the vessel. The balloon is expanded, and a tensioner is connected to the housing to apply a proximal force holding the balloon against the vessel wall to seal the puncture.

Claims

1. A method for sealing a puncture extending from a patient'"'"'s skin to a body lumen, comprising:

introducing a distal end of an occlusion member into the puncture with an expandable member thereon in a collapsed state until the expandable member is disposed within the body lumen;

expanding the expandable member to an expanded state within the body lumen;

placing a foot of a tensioner against the patient'"'"'s skin adjacent the puncture, the tensioner comprising a shaft extending from the foot, and a saddle movable along the shaft towards the foot and biased to move away from the foot;

directing the saddle along the shaft towards the foot to reduce a distance between the saddle and the foot;

connecting the saddle to a proximal end of the occlusion member; and

releasing the saddle, whereupon the saddle automatically moves away from the foot, thereby applying a proximal force on the occlusion member to hold the expandable member against a wall of the body lumen and substantially seal the puncture from the body lumen.

2. The method of claim 1, further comprising introducing a sealing compound into the puncture with the expandable member substantially sealing the body lumen from the puncture.

3. The method of claim 1, further comprising introducing a delivery sheath into the puncture, wherein the distal end of the occlusion member is introduced into the puncture through the delivery sheath, and wherein the sealing compound is introduced into the puncture through the delivery sheath.

4. The method of claim 1, further comprising collapsing the expandable member to a collapsed state, and withdrawing the occlusion member from the puncture.

5. The method of claim 1, wherein the expandable member is expanded by removing a cover overlying the expandable member, wherein the expandable member resiliently expands to an expanded state.

6. The method of claim 1, wherein the expandable member comprises a plurality of elongate struts, and wherein the expandable member is expanded by buckling an intermediate region of the struts outwardly.