Controlled Viscosity Tissue Adhesive

Abstract

Disclosed are methods and compositions for closing and sealing a wound, laceration, incision, or other percutaneous opening using an adhesive. In one preferred embodiment, the sides of the percutaneous opening are brought together in apposition and the adhesive is applied topically over the apposed opening and the skin adjacent thereto. Adhesives used in the methods of the preferred embodiments exhibit sufficient viscosity to substantially prevent flow of the adhesive into the percutaneous opening. Adhesives may also be used in surgical applications, as a covering for a trauma to the outer surface of the skin, or as a secondary means of closure in combination with other means of closure, including staples and sutures. In a preferred embodiment, the adhesive is a adhesive comprising cyanoacrylate monomer, cyanoacrylate polymer, and a plasticizer.

1 . A method of closing a percutaneous opening, having a first dermal surface on a first side of the opening and a second dermal surface on a second side of the opening and. generally coplanar with the first dermal surface, the method comprising the step of:
 applying an adhesive layer across at least a portion of the first and second dermal surfaces and spanning the opening, wherein the adhesive comprises one or more cyanoacrylate monomers, cyanoacrylate polymer, and plasticizer; and wherein the adhesive exhibits a sufficient viscosity to substantially prevent flow of the adhesive into the opening.   
   
   
       2 . A method as in  claim 1 , wherein the viscosity is within the range of from about 100 to about 50,000 centipoise. 
   
   
       3 . A method as in  claim 1 , wherein the viscosity is within the range of from about 100 to about 5,000 centipoise. 
   
   
       4 . A method as in  claim 1 , wherein the viscosity is at least about 100 centipoise. 
   
   
       5 . A method as in  claim 1 , wherein the adhesive comprises about 70-95% cyanoacrylate monomer, about 1-15% cyanoacrylate polymer, and about 2-15% plasticizer. 
   
   
       6 . A method as in  claim 5 , wherein the adhesive comprises about 80-90% cyanoacrylate monomer, about 5-10% cyanoacrylate polymer, and about 5-10% plasticizer. 
   
   
       7 . A method as in  claim 1 , wherein the cyanoacrylate monomer comprises a mixture of octylcyanoacrylate and butylcyanoacrylate. 
   
   
       8 . A method as in  claim 7 , wherein the cyanoacrylate monomer comprises about 60% to about 80% octylcyanoacrylate and about 20% to about 40% butylcyanoacrylate. 
   
   
       9 . A method as in  claim 7 , wherein the cyanoacrylate monomer comprises about 65% to about 75% octylcyanoacrylate and about 25% to about 35% butylcyanoacrylate. 
   
   
       10 . A method as in  claim 1 , wherein the cyanoacrylate polymer comprises poly(octylcyanoacrylate). 
   
   
       11 . A method as in  claim 1 , wherein the plasticizer is tributyl citrate. 
   
   
       12 . A method as in  claim 1 , wherein the adhesive layer has a thickness over the opening of at least 1 millimeter. 
   
   
       13 . A method of closing ad sealing a joint formed between a tissue of a patient and a second surface, comprising: positioning a tissue of a patient adjacent to a second surface;
 securing the tissue to the second surface using a primary closure modality to form a joint; delivering an adhesive comprising cyanoacrylate monomer, cyanoacrylate polymer, and a plasticizer to the joint; and permitting the adhesive to polymerize.   
   
   
       14 . A method as in  claim 13 , wherein the second surface is an autologous tissue, allograph tissue, animal tissue, biologically compatible metal, polymeric material, or prosthetic device. 
   
   
       15 . A method as in  claim 13 , wherein the primary closure modality is sutures or staples. 
   
   
       16 . A method as in  claim 13 , wherein the tissue and the second surface are adjacent surfaces of the skin of a patient. 
   
   
       17 . A method of closing and sealing a wound in a patient, comprising the steps of:
 identifying a percutaneous wound having first and second sides; delivering a layer of wound closure adhesive comprising one or more   cyanoacrylate monomers, cyanoacrylate polymer, and plasticizer to the surface of skin on each of the first and second sides and across the wound in a quantity sufficient to retain closure and sealing of said wound; and   restraining adhesive from entering the wound.   
   
   
       18 . A method as in  claim 17 , wherein the restraining step comprises providing the wound closure adhesive with a sufficient viscosity to extend in a layer across the wound, while substantially preventing the adhesive from entering the wound. 
   
   
       19 . A method as in  claim 18 , wherein the viscosity is at least 100 centipoise. 
   
   
       20 . A method of covering a trauma to an outer layer of a skin in a patient comprising:
 delivering an adhesive comprising cyanoacrylate monomer, cyanoacrylate polymer, and a plasticizer to a surface of the skin covering an area of the trauma to the outer layer of the skin in a quantity sufficient to cover said trauma; and   permitting the adhesive to polymerize.   
   
   
       21 . A method as in  claim 20 , further comprising applying an aqueous solution to the trauma prior to delivering the adhesive. 
   
   
       22 . A method as in  claim 20 , wherein the adhesive has a prepolymerization viscosity of at least about 100 centipoise. 
   
   
       23 . A method as in  claim 20 , wherein the trauma is selected from the group consisting of abrasions, scrapes, burns, blisters, bedsores, ulcers, chapping, and chafing.