Pretreatment for lubricated surgical needles

Abstract

A method for siliconizing surgical needles is provided whereby the needles are treated with acid before they are siliconized.

What is claimed is:  
     
         1 . A method comprising the steps of: 
 providing a surgical needle having a surface;    contacting the surface of the needle with a pretreating solution comprising an acid to form a pretreated needle.    
     
     
         2 . The method of  claim 1  wherein a lubricant composition is applied on at least a portion of the surface of the pretreated needle.  
     
     
         3 . The method of  claim 1  wherein the acid is a mineral acid selected from the group consisting of hydrochloric acid, sulfuric acid, phosphoric acid, hydrobromic acid, nitric acid, and water soluble salts thereof.  
     
     
         4 . The method of  claim 1  wherein the acid is an organic acid selected from the group consisting of citric acid, acetic acid, tartaric acid, trifluoroacetic acid, and water soluble salts thereof.  
     
     
         5 . The method of  claim 1  wherein the pretreating solution comprises citric acid in a concentration of about 1.0 wt. % to about 10 wt. %.  
     
     
         6 . The method of  claim 2  further comprising the step of rinsing the surface of the needle after applying the pretreating solution but before applying the lubricant composition.  
     
     
         7 . The method of  claim 2  wherein the lubricant composition comprises a silicone.  
     
     
         8 . The method of  claim 2  wherein the lubricant composition comprises an aminoalkyl siloxane.  
     
     
         9 . The method of  claim 8  wherein the lubricant composition further comprises a second siloxane that is copolymerizable with the aminoalkyl siloxane.  
     
     
         10 . The method of  claim 8  wherein the lubricant composition further comprises a second siloxane that does not copolymerize with the aminoalkyl siloxane.  
     
     
         11 . The method of  claim 8  further comprising the step of curing the aminoalkyl siloxane.  
     
     
         12 . The method of  claim 2  wherein the lubricant composition comprises a polydimethylsiloxane having amino and alkoxy functional groups.  
     
     
         13 . The method of  claim 2  wherein the lubricant composition comprises a polydimethylsiloxane and hexane.  
     
     
         14 . The method of  claim 11  wherein the step of curing the lubricant composition comprises: 
 subjecting the lubricant composition to an atmosphere of from about 20% to about 80% relative humidity, at a temperature from about 10° C. to about 50° C. for a time period ranging from about 1 hour to about 6 hours; and,  
 heating to a temperature of from about 100° C. to about 200° C. for a time period ranging from about 2 hours to about 48 hours to effectively polymerize the lubricant composition.  
 
     
     
         15 . A method for manufacturing a siliconized surgical needle comprising the steps of: 
 providing a surgical needle having a surface;    contacting the surface of the needle with a pretreating solution comprising an acid to form a pretreated needle;    applying a lubricant composition to at least a portion of the surface of the pretreated needle, the lubricant composition comprising at least one polydialkylsiloxane and at least one other siliconization material which does not covalently bond with the polydialkylsiloxane, the siliconization material being capable of crosslinking; and,    curing the lubricant composition on the surface of the needle whereby the siliconization material cross-links to physically interlock the polydialkylsiloxane in the coating and provide an interpenetrating network coating.    
     
     
         16 . The method of  claim 15  wherein the acid is a mineral acid selected from the group consisting of hydrochloric acid, sulfuric acid, phosphoric acid, hydrobromic acid, nitric acid, and water soluble salts thereof.  
     
     
         17 . The method of  claim 15  wherein the acid is an organic acid selected from the group consisting of citric acid, acetic acid, tartaric acid, trifluoroacetic acid, and water soluble salts thereof.  
     
     
         18 . The method of  claim 15  further comprising the step of rinsing the surface of the needle after applying the pretreating solution but before applying the lubricant composition.  
     
     
         19 . The method of  claim 15  wherein the step of curing comprises: 
 subjecting the lubricant composition to an atmosphere of from about 20% to about 80% relative humidity, at a temperature from about 10° C. to about 50° C. for a time period ranging from about 1 hour to about 6 hours; and,  
 heating to a temperature of from about 100° C. to about 200° C. for a time period ranging from about 2 hours to about 48 hours.  
 
     
     
         20 . An article of manufacture comprising: 
 a surgical needle having a tip portion, a body portion and suture attachment portion, at least a portion of a surface of the surgical needle being acid-treated; and    a silicone-containing coating applied over the acid-treated portion of the surgical needle.    
     
     
         21 . An article of manufacture as in  claim 20  wherein the silicone-containing coating comprises an aminoalkyl siloxane.  
     
     
         22 . An article of manufacture as in  claim 20  wherein the silicone-containing coating comprises an interpenetrating network.  
     
     
         23 . An article of manufacture as in  claim 20  wherein the silicone-containing coating comprises a copolymer of an aminoalkyl siloxane and a second siliconization material.  
     
     
         24 . A surgical needle having reduced penetration force comprising: 
 a surgical needle having an acid-treated surface; and    a silicone-containing coating on at least a portion of the acid treated surface,    whereby the surgical needle has a penetration force on a fifth pass through tissue that is at least 10% less than the penetration force on a fifth pass through tissue of a needle having the same silicone-containing coating on the same surgical needle having no surface that is acid treated.    
     
     
         25 . A surgical needle as in  claim 24  wherein the silicone-containing coating comprises an aminoalkyl siloxane.  
     
     
         26 . An article of manufacture as in  claim 24  wherein the silicone-containing coating comprises an interpenetrating network.  
     
     
         27 . An article of manufacture as in  claim 24  wherein the silicone-containing coating comprises a copolymer of an aminoalkyl siloxane and a second siliconization material.