Biopsy incision closure device

Abstract

A biopsy incision closure device includes a base having a frame incorporated therein. Together, the base and frame define an opening for performing a biopsy incision when the device is placed over a tissue surface. The base is typically composed of an elastomeric material and the frame comprises resilient inelastic members which can be used to close the opening in a highly uniform manner with minimum distortion and stress introduced into the tissue edges being drawn together.

1 . A biopsy incision closure device comprising:
 a base having an opening and a tissue-adhering surface, the base being formed from a first material; and   a frame incorporated in the base, the frame having a first leg disposed along one side of the opening and a second leg disposed along an opposed side of the opening, the frame being formed from a second material more rigid than the first material;   wherein the frame has a first configuration wherein the legs hold the opening in an elliptical shape through which the biopsy can be performed and a second configuration wherein the legs close the opening.   
     
     
         2 . A device as a  claim 1 , wherein the first material comprises a soft elastomeric material. 
     
     
         3 . A device as in  claim 2 , wherein the elastomeric material is selected from the group consisting of silicone rubber. 
     
     
         4 . A device as in  claim 1 , wherein the base comprises a woven fabric. 
     
     
         5 . A device as in  claim 1 , wherein the base comprises two or more laminated layers. 
     
     
         6 . A device as in  claim 1 , wherein the second material comprises a hard, flexible plastic or metal. 
     
     
         7 . A device as in  claim 6 , wherein the first material comprises a soft elastomeric material molded over the frame. 
     
     
         8 . A device as in  claim 1 , wherein the frame is in the closed leg configuration when no biasing forces are applied to the frame. 
     
     
         9 . A device as in  claim 8 , wherein the frame is opened by axially compressing the first and second legs which causes them to deform into the elliptical, wherein a user can adjust the size of the opening by varying the amount of axial compression. 
     
     
         10 . A device as in  claim 1 , wherein the frame is in the open leg configuration when no biasing forces are applied to the frame. 
     
     
         11 . A device as a  claim 10 , further comprising a latching mechanism which hold the legs in a closed or partially closed configuration. 
     
     
         12 . A device as in  claim 11 , wherein the latching mechanism is adjustable to hold the legs together at varying spacings there between. 
     
     
         13 . A device as in  claim 12 , wherein the latching mechanism compresses a ratchet member which extends between the first leg and the second leg. 
     
     
         14 . A device as in  claim 1 , wherein the legs are joined together at each end by hinges. 
     
     
         15 . A device as in  claim 14 , wherein the hinge comprises a keyhole. 
     
     
         16 . A device as in  claim 14 , wherein the hinge comprises a leaf spring structure which applies an outward force which flattens the tissue at each end of an incision when the frame is closed. 
     
     
         17 . A device as in  claim 14 , wherein the hinge comprises a living hinge, a ball and socket, a barrel and pin, a coil spring, or ball ends embedded in the base. 
     
     
         18 . A device as in  claim 1 , wherein the base stretches preferentially in the axial direction. 
     
     
         19 . A device as in  claim 18 , wherein the first material comprises an anisotropic material which has a higher elasticity in the axial direction than in a lateral direction. 
     
     
         20 . A device as in  claim 18 , wherein the first material has isotropic elastic properties, and wherein the base is reinforced to inhibit stretching in a lateral direction while allowing uninhibited stretching in the axial direction. 
     
     
         21 . A device as in  claim 20 , wherein the frame comprises lateral reinforcement elements which inhibit lateral stretching of the base. 
     
     
         22 . A biopsy incision closing device as in  claim 1 , further comprising an eversion lip along each of the first and second legs of the frame, wherein the eversion lip is oriented to adhere to tissue within the opening and to deflect upwardly as the frame is closed to evert the edges of the tissue upwardly.