Redundant tissue closure methods and apparatuses

Abstract

A tissue closure device including a tissue eversion apparatus, and a first and a second, redundant closure element that are placed on the external surface of a tissue puncture wound to enhance the efficacy of closure. The first closure element and the second closure element are left resident on the external surface of or in proximity to the tissue puncture wound in order to provide redundancy of closure.

What is claimed is: 
     
         1 . A method of closing an opening in a body lumen, comprising:
 (a) deploying a tissue eversion apparatus into the opening in the body lumen;   (b) everting edges of the opening with a plurality of elongate tissue engaging members to form an everted tissue region;   (b) deploying a first closure element in a first configuration to the everted tissue region around the opening in the body lumen;   (c) transitioning the first closure element to a second smaller configuration so as to close the opening in the body lumen; and   (d) retracting the tissue eversion apparatus so as to release the everted edges.   
     
     
         2 . The method as recited in  claim 1 , further comprising deploying a second closure element over or around the first closure element so as to redundantly close the opening in the body lumen. 
     
     
         3 . The method as recited in  claim 2 , optionally performing deploying of the second closure element before retracting the tissue eversion apparatus. 
     
     
         4 . The method as recited in  claim 2 , the tissue eversion apparatus, the first closure element, and the second closure element being operatively coupled to the tubular member and deployable therefrom. 
     
     
         5 . The method as recited in  claim 1 , the elongate tissue engaging members of the tissue eversion apparatus having a first configuration substantially parallel to a long axis of the tubular member when disposed within the tubular member, and having a second configuration curving away from the long axis of the tubular member when the elongate tissue engaging members are deployed from the tubular member. 
     
     
         6 . The method as recited in  claim 1 , the deploying the tissue eversion apparatus further comprising:
 inserting at least a portion of the tissue eversion apparatus into the opening in the body lumen, the plurality of elongate tissue engaging members having a first configuration characterized by a long axis;   projecting the plurality of elongate tissue engaging members into the opening in the body lumen causing a distal portion of the elongate tissue engaging members to adopt a second configuration curving away from the long axis; and   partially retracting the tissue eversion apparatus causing the distal portion of the tissue engaging members to engage with tissue around the opening and forming the everted tissue region.   
     
     
         7 . The method as recited in  claim 6 , the elongate tissue engaging members having sharpened distal ends configured to penetrate a portion of the everted tissue region. 
     
     
         8 . The method as recited in  claim 6 , further comprising deploying the first closure element on the everted tissue region distal to the tissue engaging members. 
     
     
         9 . A method of closing an opening in a body lumen, comprising:
 (a) deploying a tissue eversion apparatus into the opening in the body lumen, the tissue eversion apparatus having a plurality of elongate tissue engaging members capable of approximating and everting edges of the opening to form an everted tissue region;   (b) deploying a first closure element in a first configuration to the everted tissue region around the opening in the body lumen;   (c) transitioning the first closure element to a second smaller configuration so as to close the opening in the body lumen;   (d) retracting the tissue eversion apparatus so as to release the everted edges; and   (e) deploying a second closure element over or around the first closure element so as to redundantly close the opening in the body lumen.   
     
     
         10 . The method as recited in  claim 9 , optionally performing act (e) before performing act (d). 
     
     
         11 . The method as recited in  claim 9 , the deploying the tissue eversion apparatus further comprising:
 inserting at least a portion of the tissue eversion apparatus into the opening in the body lumen, the plurality of elongate tissue engaging members having a first configuration characterized by a long axis;   projecting the plurality of elongate tissue engaging members into the opening in the body lumen causing a distal portion of the elongate tissue engaging members to adopt a second configuration curving away from the long axis; and   partially retracting the tissue eversion apparatus causing the distal portion of the tissue engaging members to engage with tissue around the opening and forming the everted tissue region.   
     
     
         12 . The method as recited in  claim 9 , the first closure element being a cincture element, the cincture element being selected from a group consisting of a loop of suture having at least one pre-tied slip-knot, a shape memory material having an expanded deliver configuration and a deployed configuration that resiliently closes the opening when the first closure element is deployed around the everted tissue region, and combinations thereof. 
     
     
         13 . The method as recited in  claim 9 , the second closure element being selected from a group consisting of sealant plugs, adhesive glues, occlusive substances, extraluminal clips, RF energy, thermal energy, electrical induction, infrared light, ultrasonic vibration, microwave or laser irradiation, sutures, and combinations thereof. 
     
     
         14 . A method of closing an opening in a blood vessel, comprising:
 (a) inserting a tubular member having a proximal end and a distal end regions, an exterior surface, and a lumen extending along an entire length of the tubular member into the opening in the blood vessel;   (b) deploying a tissue eversion apparatus having a plurality of elongate tissue engaging members capable of approximating and everting edges of the opening to form an everted tissue region, the tissue eversion apparatus being disposed within the lumen of the tubular member and deployable therefrom;   (c) partially withdrawing the tubular member proximally causing a distal portion of the tissue engaging members to engage with tissue around the opening and forming the everted tissue region;   (d) applying a first closure element in a first configuration to the everted tissue region distal to the tissue engaging members, the first closure element being operatively coupled to tubular member and deployable therefrom;   (e) transitioning the first closure element to a second smaller configuration so as to close the opening in the blood vessel;   (f) retracting the tissue eversion apparatus so as to release the everted edges; and   (g) applying a second closure element over or around the first closure element so as to redundantly close the opening in the body lumen, the second closure element being operatively coupled to the tubular member and deployable therefrom.   
     
     
         15 . The method as recited in  claim 14 , optionally performing act (g) before performing act (f). 
     
     
         16 . The method as recited in  claim 14 , the elongate tissue engaging members of the tissue eversion apparatus having a first configuration substantially parallel to a long axis of the tubular member when disposed within the tubular member, and having a second configuration curving away from the long axis of the tubular member when the elongate tissue engaging members are deployed from the tubular member. 
     
     
         17 . The method as recited in  claim 14 , the elongate tissue engaging members having sharpened distal ends configured to penetrate a portion of the everted tissue region. 
     
     
         18 . The method as recited in  claim 14 , the first closure element being a cincture element, the cincture element being selected from a group consisting of a loop of suture having at least one pre-tied slip-knot, a shape memory material having an expanded deliver configuration and a deployed configuration that resiliently closes the opening when the first closure element is deployed around the everted tissue region, and combinations thereof. 
     
     
         19 . The method as recited in  claim 14 , the second closure element being selected from a group consisting of sealant plugs, adhesive glues, occlusive substances, extraluminal clips, RF energy, thermal energy, electrical induction, infrared light, ultrasonic vibration, microwave or laser irradiation, sutures, and combinations thereof.