US2016135833A1PendingUtilityA1

Tissue access site system and method

Assignee: APICA CARDIOVASCULAR IRELAND LTDPriority: Jul 7, 2008Filed: Jan 20, 2016Published: May 19, 2016
Est. expiryJul 7, 2028(~2 yrs left)· nominal 20-yr term from priority
A61B 17/3209A61B 17/0482A61B 17/3415A61B 17/3417A61M 29/00A61B 2017/3454A61B 2017/00672A61B 2017/00637A61B 2017/22038A61B 2017/00778A61B 17/32053A61B 2017/0472A61B 2017/00663A61B 17/0057A61B 17/0469A61B 17/08
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Claims

Abstract

A tissue access site system and methods for opening and closing a tissue access site are provided. A method for opening and closing an access site in a body lumen includes attaching a plurality of closure elements to a perimeter wall of a body lumen by advancing closure elements from an access and closure device associated with a guide wire positioned through the perimeter wall. A tissue cutting element of the access and closure device is advanced along the guide wire to cause the tissue cutting element to penetrate through the perimeter wall to open an access site in the perimeter wall that includes a plurality of tissue flaps. Each of the tissue flaps has a predetermined geometry and is attached to at least one of the closure elements. The closure elements are used to close the access site.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for opening and closing an access site in a body lumen, the method comprising:
 attaching a plurality of closure elements to a perimeter wall of a body lumen by advancing the plurality of closure elements from an access and closure device associated with a guide wire positioned through the perimeter wall;   advancing a tissue cutting element of the access and closure device along the guide wire to cause the tissue cutting element to penetrate through the perimeter wall to open an access site in the perimeter wall that includes a plurality of tissue flaps, each of the plurality of tissue flaps having a predetermined geometry and attached to at least one of the plurality of closure elements; and   inserting a medical instrument and/or a sheath into the body lumen through the access site;   removing the medical instrument and/or the sheath from the body lumen through the access site; and   using the plurality of closure elements to close the access site.   
     
     
         2 . The method of  claim 1 , wherein:
 the tissue cutting element comprises a central rod and a plurality of blades positioned in a circumferential array around the central rod; and   the plurality of blades and the central rod are jointly penetrated through the perimeter wall to generate the access site.   
     
     
         3 . The method of  claim 1 , wherein:
 the tissue cutting element comprises a central rod and a plurality of deployable blades supported by the central rod and reconfigurable between a stowed configuration and a deployed configuration in which the deployable blades are positioned in a circumferential array around the central rod;   the tissue cutting element is penetrated into the body lumen with the deployable blades in the stowed configuration;   the deployable blades are reconfigured from the stowed configuration to the deployed configuration; and   the tissue cutting element is retracted along the guide wire with the deployable blades in the deployed configuration to cut the perimeter wall to form the plurality of tissue flaps.   
     
     
         4 . The method of  claim 1 , further comprising:
 exposing an external surface of the perimeter wall of the body lumen; and   advancing a housing of the access and closure device along the guide wire into contact with the external surface of the perimeter wall.   
     
     
         5 . The method of  claim 4 , wherein advancing the tissue cutting element along the guide wire comprises advancing the tissue cutting element relative to the housing while the housing contacts the external surface of the perimeter wall. 
     
     
         6 . The method of  claim 5 , comprising:
 advancing a plurality of tubes of the access and closure device along the guide wire relative to the housing into contact with the external surface of the perimeter wall while the housing contacts the external surface of the perimeter wall; and   ejecting the plurality of closure elements from the plurality of tubes into the body lumen through the perimeter wall.   
     
     
         7 . The method of  claim 1 , wherein the plurality of closure elements comprises a plurality of sutures. 
     
     
         8 . The method of  claim 7 , wherein attaching the plurality of closure elements to the perimeter wall comprises:
 penetrating an end of each of the plurality of sutures through the perimeter wall; and   pulling the end of each of the plurality of sutures out of the body lumen through the access site via retraction of a suture drawing element.   
     
     
         9 . The method of  claim 8 , wherein:
 the tissue cutting element comprises the suture drawing element; and   the suture drawing element is retracted by retracting the tissue cutting element.   
     
     
         10 . The method of  claim 7 , wherein the plurality of sutures are advanced through tissue overlying the perimeter wall of the body lumen. 
     
     
         11 . The method of  claim 1 , wherein the plurality of closure elements comprises a plurality of metal clips. 
     
     
         12 . The method of  claim 1 , wherein the plurality of closure elements is ejected from a respective plurality of tubes of the access and closure device. 
     
     
         13 . The method of  claim 1 , wherein the tissue cutting element comprises a lumen through which the guide wire extends. 
     
     
         14 . The method of  claim 1 , wherein the plurality of closure elements is attached to the perimeter wall prior to advancing the tissue cutting element along the guide wire to generate the access site. 
     
     
         15 . The method of  claim 1 , wherein the plurality of closure elements is attached to the perimeter wall during advancement of the tissue cutting element along the guide wire to generate the access site. 
     
     
         16 . The method of  claim 1 , wherein the plurality of closure elements is attached to the perimeter wall subsequent to advancing the tissue cutting element along the guide wire to generate the access site. 
     
     
         17 . The method of  claim 1 , wherein advancing the tissue cutting element along the guide wire comprises advancing the tissue cutting element through tissue overlying the perimeter wall of the body lumen. 
     
     
         18 . The method of  claim 1 , wherein the tissue cutting element is advanced along the guide wire in a direction approximately 45 degrees to a direction in which the body lumen extends. 
     
     
         19 . A method for opening and closing an access site in a blood vessel, the method comprising:
 positioning an access and closure device relative to a blood vessel;   advancing a plurality of closure elements from the access and closure device into the blood vessel;   advancing a tissue cutting element of the access and closure device to penetrate the blood vessel to open an access site in the blood vessel that includes a plurality of tissue flaps, each of the plurality of tissue flaps having a predetermined geometry and penetrated by at least one of the plurality of closure elements; and   using the plurality of closure elements to close the access site.   
     
     
         20 . The method of  claim 19 , further comprising penetrating a guide wire into the blood vessel through a perimeter wall of the blood vessel, wherein the tissue cutting element is advanced along the guide wire.

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