Surgical system and methods of use

Abstract

A surgical system including an implantable medical device having a size and shape. The surgical device having a substrate and a coating that covers at least a portion of the substrate. The coating including collagen, glycerin and a hemostatic agent. The substrate including a first piece and a second piece that is joined with the first piece. The first piece and the second piece forming a pocket having a cavity and an opening that is in communication with the cavity. The device being pre-formed such that a size and shape of the cavity conforms to the size and shape of the implantable medical device.

What is claimed is: 
     
         1 . A surgical system comprising:
 an implantable medical device having a size and shape;   a surgical device comprising a substrate and a coating that covers at least a portion of the substrate, the coating comprising collagen, glycerin and a hemostatic agent, the substrate comprising a first piece and a second piece that is joined with the first piece, the first piece and the second piece forming a pocket having a cavity and an opening that is in communication with the cavity, the device being pre-formed such that a size and shape of the cavity conforms to the size and shape of the implantable medical device.   
     
     
         2 . The surgical system recited in  claim 1 , wherein the implantable medical device is configured to be inserted through the opening and into the cavity. 
     
     
         3 . The surgical system recited in  claim 1 , wherein the implantable medical device is a pacemaker. 
     
     
         4 . The surgical system recited in  claim 1 , wherein the implantable medical device is a cardioverter-defibrillator. 
     
     
         5 . The surgical system recited in  claim 1 , wherein the implantable medical device is positioned in the cavity. 
     
     
         6 . The surgical system recited in  claim 5 , wherein the implantable medical device is a pacemaker. 
     
     
         7 . The surgical system recited in  claim 5 , wherein the implantable medical device is a cardioverter-defibrillator. 
     
     
         8 . The surgical system recited in  claim 1 , wherein the hemostatic agent is trans-4-(aminomethyl)cyclohexanecarboxylic acid (C 8 H 15 NO 2 ). 
     
     
         9 . The surgical system recited in  claim 1 , wherein the coating consists of collagen, glycerin and the hemostatic agent. 
     
     
         10 . The surgical system recited in  claim 1 , wherein the collagen is CPP collagen. 
     
     
         11 . The surgical system recited in  claim 1 , wherein the collagen is CPX collagen. 
     
     
         12 . The surgical system recited in  claim 1 , wherein the coating is free of ECM collagen. 
     
     
         13 . The surgical system recited in  claim 1 , further comprising a package, the package including an aperture and an insert positioned within the aperture, the insert being configured to be positioned in the cavity to maintain the size and shape of the cavity. 
     
     
         14 . The surgical system recited in  claim 1 , further comprising a package, the package including an aperture and an insert positioned within the aperture, the insert being positioned in the cavity to maintain the size and shape of the cavity. 
     
     
         15 . A surgical system comprising:
 a package, the package including an aperture and an insert positioned within the aperture;   an implantable medical device having a size and shape, wherein the implantable medical device is a pacemaker or a cardioverter-defibrillator;   a surgical device comprising a substrate and a coating that covers at least a portion of the substrate, the coating comprising collagen, glycerin and a hemostatic agent, the collagen including CPP collagen or CPX collagen, the substrate comprising a first piece and a second piece that is joined with the first piece, the first piece and the second piece forming a pocket having a cavity and an opening that is in communication with the cavity, the device being pre-formed such that a size and shape of the cavity conforms to the size and shape of the implantable medical device, the insert being positioned in the cavity to maintain the size and shape of the cavity.   
     
     
         16 . The surgical system recited in  claim 15 , wherein the hemostatic agent is trans-4-(aminomethyl)cyclohexanecarboxylic acid (C 8 H 15 NO 2 ). 
     
     
         17 . The surgical system recited in  claim 16 , wherein the coating consists of collagen, glycerin and the hemostatic agent. 
     
     
         18 . A surgical system comprising:
 a package, the package including an aperture and an insert positioned within the aperture;   an implantable medical device having a size and shape, wherein the implantable medical device is a pacemaker or a cardioverter-defibrillator;   a surgical device comprising a substrate and a coating that covers at least a portion of the substrate, the coating comprising collagen, glycerin and a hemostatic agent, the collagen including CPP collagen or CPX collagen, the substrate comprising a first piece and a second piece that is joined with the first piece, the first piece and the second piece forming a pocket having a cavity and an opening that is in communication with the cavity, the device being pre-formed such that a size and shape of the cavity conforms to the size and shape of the implantable medical device, the implantable medical device being positioned in the cavity, the insert being configured to be positioned in the cavity to maintain the size and shape of the cavity.   
     
     
         19 . The surgical system recited in  claim 18 , wherein the hemostatic agent is trans-4-(aminomethyl)cyclohexanecarboxylic acid (C 8 H 15 NO 2 ). 
     
     
         20 . The surgical system recited in  claim 19 , wherein the coating consists of collagen, glycerin and the hemostatic agent.