Kits for surgical repair of soft tissue defects and components, packaging, and methods of use thereof

Abstract

The present disclosure describes kits for surgical repair of soft tissue defects, including hernias. The kits include any combination of components selected from an implantable sheet, a central tie, a delivery device, an insertion member, and/or a rolling device. Packaging for the kits and/or components and methods of using the kits and/or components are also provided.

What is claimed is: 
     
         1 . A two-piece delivery device configured to deliver an implantable sheet, the delivery device comprising:
 a first body member including a central arm extending between a first proximal end portion and a first distal end portion, the first proximal end portion including a tube defining a tube lumen and the first distal end portion including a body locking recess defined therein, and   a second body member positioned on top of the first body member, the second body member including a pair of resilient arms extending between a second proximal end portion and a second distal end portion, the second proximal end portion including a handle received within the tube lumen of the first body member, and the distal end portion including a locking member received within the body locking recess of the first body member locking the first body member to the second body member.   
     
     
         2 . The two-piece delivery device of  claim 1 , wherein the tube further comprises a tube slot extending a length of the tube forming a split tube. 
     
     
         3 . The two-piece delivery device of  claim 1 , wherein the central arm comprises at least a first area which defines a T-shaped cross-section. 
     
     
         4 . The two-piece delivery device of  claim 1 , wherein the central arm further comprises a second area which defines a T-shaped cross-section, the second area separated longitudinally along the central arm from the first area by a space. 
     
     
         5 . The two-piece delivery device of  claim 4 , wherein the space of the central arm further comprises one or more tie holes defined therethrough. 
     
     
         6 . The two-piece delivery device of  claim 1 , wherein the first distal end portion of the first body member further comprises a slot distal the locking recess, the slot separating the first distal end portion of the first body member into an upper and lower jaw member, the slot configured to secure a distal end portion of an implantable sheet between the upper and lower jaw members. 
     
     
         7 . The two-piece delivery device of  claim 1 , wherein the pair of resilient arms are configured to transition between an expanded configuration with the pair of resilient arms spaced farthest apart from each other and a restrained configuration with the pair of resilient arms generally adjacent each other. 
     
     
         8 . The two-piece delivery device of  claim 1 , wherein the handle is configured to slide longitudinally within the tube lumen of the tube. 
     
     
         9 . A two-piece delivery device configured to deliver an implantable sheet, the delivery device comprising:
 a first body member including a pair of resilient arms extending between a first proximal end portion and a first distal end portion, the first proximal end portion including a first tube defining a first tube lumen and the first distal end portion including a second tube defining a second tube lumen, the second tube further including a body locking recess defined therein, and   a second body member including an arm extending between a second proximal end portion and a second distal end portion, the second proximal end portion received within the first tube lumen of the first body member, and the second distal end portion including a body locking member and a slot distal the locking member, the locking member received within the body locking recess of the first body member locking the first body member to the second body member and the slot separating the second distal end portion of the second body member into an upper and lower jaw member, the slot configured to secure a distal end portion of an implantable sheet between the upper and lower jaw members.   
     
     
         10 . The two-piece delivery device of  claim 9 , wherein the first tube lumen defines a generally square-shaped cross-section. 
     
     
         11 . The two-piece delivery device of  claim 10 , wherein the first tube lumen further comprises a guide member extending a length of the first tube lumen and protruding into at least one side of the square-shaped cross-section. 
     
     
         12 . The two-piece delivery device of  claim 11 , wherein at least the second proximal end portion of the second body member defines a generally square-shaped cross-section including at least one groove extending a length of the second body member, the groove configured to accommodate the guide member. 
     
     
         13 . The two-piece delivery device of  claim 9 , wherein each of the pair of the resilient arms define a half-moon cross-section. 
     
     
         14 . The two-piece delivery device of  claim 9 , wherein the central arm further comprises first and second tie holes defined therethrough. 
     
     
         15 . The two-piece delivery device of  claim 9 , wherein the pair of resilient arms are configured to transition between an expanded configuration with the pair of resilient arms spaced farthest apart from each other and a restrained configuration with the pair of resilient arms generally adjacent each other. 
     
     
         16 . The two-piece delivery device of  claim 9 , wherein the first tube is configured to slide longitudinally along the second proximal end portion of the second body member. 
     
     
         17 . A surgical kit comprising:
 a two-piece delivery device configured to deliver an implantable sheet; and   an insertion member including:
 an insertion member having an elongate body extending between an insertion end portion including a first socket and a rolling end portion including a second socket, the insertion member defining a first longitudinal axis, and each of the first and second sockets being configured to matingly engage the proximal end portion of the one-piece delivery device, 
 a clamp tube having a tubular body extending between a first clamp tube end portion configured to attach to and extend away from the rolling end portion of the insertion member and a second clamp tube end portion opposite the first tube end portion, the second clamp tube end portion free of the insertion member and configured to receive at least the proximal end portion of the delivery device therein to transition a pair of resilient arms from an expanded configuration to a restrained configuration, and 
 a finger extending between a fixed first end portion and a free second end portion, the fixed first end portion affixed to the rolling end portion of the insertion member, the free second end portion extending away from the rolling end portion of the insertion member and over at least the first clamp tube end portion of the clamp tube, the free second end portion of the finger defining a sheet gap between the finger and the clamp tube, the sheet gap configured to receive and maintain a proximal end of an implantable mesh. 
   
     
     
         18 . The surgical kit of  claim 15 , wherein the clamp tube further comprises one or more longitudinal slots defined therethrough.