Valve body, process for producing valve body, and medical instrument including the valve body

Abstract

A valve body, e.g. a valve body adapted to be disposed in a connector to be connected to a catheter, has an opening/closing part which opens upon inserting a member into the opening/closing part and which closes upon withdrawing the member from the opening/closing part. The valve body includes a main body part made of a silicone rubber and a surface layer disposed on a surface of the main body part. This surface layer serves as a sliding surface which, when a guide wire has been inserted into the opening/closing part, slides on the guide wire. The surface layer is constituted mainly of silicon oxide and hence improves the sliding properties of the guide wire. Thus, the valve body is reduced in the resistance of sliding on the guide wire.

1 . A medical instrument comprising:
 a tubular medical instrument main body through which extends a lumen which is open at opposite ends;   a valve body positioned in the lumen of the tubular medical instrument main body, the valve body comprising an opening/closing part which opens when an elongated member is slidably inserted into the opening/closing part and which closes when the elongated member is slidably withdrawn from the opening/closing part;   at least the opening/closing part of the valve body has a main body part made of a silicone rubber;   the main body possessing a surface on which is provided a surface layer that contacts the elongated member when the elongated member is slidably inserted into the opening/closing part;   the surface layer which contacts the elongated member when the elongated member is slidably inserted into the opening/closing part being a material different from the main body part; and   the material of the surface layer including silicon oxide.   
     
     
         2 . The medical instrument according to  claim 1 , wherein the medical instrument is an introducer or a Y-connector. 
     
     
         3 . A valve body comprising:
 an opening/closing part which opens upon inserting a member into the opening/closing part and which closes upon withdrawing the member from the opening/closing part;   at least the opening/closing part of the valve body has a main body part comprised of a silicone rubber;   a surface layer provided on a surface of at least the main body part; and   the surface layer being comprised of silicon oxide.   
     
     
         4 . The valve body according to  claim 3 , wherein the surface layer has an average thickness of 10 nm to 100 μm. 
     
     
         5 . The valve body according to  claim 3 , wherein the surface layer is comprised of an aggregate of silicon oxide. 
     
     
         6 . The valve body according to  claim 3 , wherein the surface layer is comprised of an aggregate of particles of silicon oxide. 
     
     
         7 . The valve body according to  claim 3 , wherein the surface layer is comprised of a plurality of spaced apart dots dispersed on the surface of the main body part and together forming a plurality of spaced apart projecting surface layers. 
     
     
         8 . The valve body according to  claim 7 , wherein each of the dots projects from the surface of the main body part. 
     
     
         9 . The valve body according to  claim 8 , wherein the dots possess a projection height at which the dots project from the surface of the main body part, the projection height of the dots being 500 nm to 50 μm. 
     
     
         10 . The valve body according to  claim 7 , wherein the plurality of projecting surface layers are arranged in a density of 300 to 3000 pieces/mm 2 . 
     
     
         11 . The valve body according to  claim 3 , wherein the main body part extends throughout the valve body, and the surface layer covering the entire surface of the main body part. 
     
     
         12 . The valve body according to  claim 3 , further comprising, between the main body part and the surface layer, an intermediate layer comprised of a material which transitions between a material constituting the main body part and a material constituting the surface layer. 
     
     
         13 . The valve body according to  claim 12 , wherein a content of an organic component in the intermediate layer gradually decreases from a side of the main body part toward a side of the surface layer. 
     
     
         14 . The valve body according to  claim 12 , wherein each of the surface layer and the intermediate layer is a laser beam-irradiated layer. 
     
     
         15 . The valve body according to  claim 3 , wherein the opening/closing part is comprised of at least one slit. 
     
     
         16 . The valve body according to  claim 3 , wherein an overall shape of the valve body is a columnar shape or plate-shape. 
     
     
         17 . The valve body according to  claim 1 , wherein the member to be inserted is a sheath, a dilator, a catheter, a guide wire or a needle. 
     
     
         18 . A process for producing a valve body comprising an opening/closing part which opens upon inserting a member into the opening/closing part and which closes upon withdrawing the member from the opening/closing part, the process comprising:
 forming a surface layer comprised of silicon oxide at least in a region that includes the opening/closing part; and   the surface layer comprised of silicon oxide being formed on a surface of a base material having the opening/closing part, the base material on which is formed the surface layer comprised of silicon oxide being a silicone rubber.   
     
     
         19 . The process for producing the valve body according to  claim 18 , wherein the forming of the surface layer of silicon oxide comprises irradiating at least a region of a surface of the opening/closing part with a laser beam so that the silicone rubber in the region is modified into silicon oxide and raised. 
     
     
         20 . The process for producing the valve body according to  claim 19 , wherein the laser beam has a wavelength of not more than 200 nm. 
     
     
         21 . The process for producing the valve body according to  claim 19 , wherein the irradiating with the laser beam comprises directing the laser beam through a photomask having a window part of a predetermined shape, the irradiation of the surface layer of silicone rubber with the laser beam modifying the silicone rubber into silicon oxide in the region having a shape corresponding to the predetermined shape. 
     
     
         22 . The process for producing the valve body according to  claim 21 , wherein the photomask is comprised of a mesh-shaped member or a punching metal. 
     
     
         23 . The process for producing the valve body according to  claim 18 , wherein the surface layer is formed by forming a layer of silicon oxide at least in a region of a surface of the opening/closing part. 
     
     
         24 . The process for producing the valve body according to  claim 18 , wherein the surface layer is formed by forming a silicon layer at least in a region on a surface of the opening/closing part, and thereafter subjecting the silicon layer to an oxidizing treatment so as to modify silicon into silicon oxide.