Biocompatible and biostable implantable medical device

Abstract

The present invention is related to a biocompatible and biostable implantable medical device. The present invention can include an implantable medical device including an electro-mechanical component. The electro-mechanical component can be coated with various novel and nonobvious coating combinations designed to promote biocompatibility and biostability. One layer of the coating combinations can be a tie layer. Another layer of the coating combinations can be a layer formed on top of the tie layer, and having biocompatible and biostable properties.

1 . An access port for use in conjunction with a gastric band, the access port comprising:
 a housing; and   an electro-mechanical component located within the housing, wherein the electro-mechanical component is coated with a coating combination.   
     
     
         2 . The access port of  claim 1 , wherein the gastric band is a hydraulically adjustable gastric band. 
     
     
         3 . The access port of  claim 1  further comprising:
 a penetrable septum formed on the housing; and 
 a conduit configured to carry fluid between the penetrable septum and an inflatable portion of the gastric band. 
 
     
     
         4 . The access port of  claim 3 , wherein the electro-mechanical component is a pressure sensor in communication with a fluid within the gastric band and configured to monitor a parameter of the fluid, generate a pressure value signal based on the parameter, and communicate the pressure value signal to an external control unit via RF telemetry. 
     
     
         5 . The access port of  claim 4 , further comprising a plate element positioned between the penetrable septum and the pressure sensor to guard the pressure sensor against a needle damaging it. 
     
     
         6 . The access port of  claim 1 , wherein the electro-mechanical component is a printed circuit board assembly. 
     
     
         7 . The access port of  claim 1 , wherein the electro-mechanical component is a motor. 
     
     
         8 . The access port of  claim 1  wherein the coating combination includes a tie layer. 
     
     
         9 . The access port of  claim 1 , wherein the coating combination comprises at least two different layers selected from the group consisting of parylene, diamond like carbon, titanium nitride, titanium carbide, silicon nitride, cyclo olefin copolymer, cyclo olefin polymer, epoxy, silicone polymer, glass, chloro-tri-fluoro-ethylene, poly-chloro-tri-fluoro-ethylene, poly-ether-ether-ketone, polysulfone, polyoxymethylene, polypropylene, liquid crystal polymer, ultra high molecular weight polyethylene, fluoropolymer acrylate, and synthetic diamond. 
     
     
         10 . The access port of  claim 9 , wherein the at least two different layers are applied by one or more of chemical vapor deposition, physical vapor deposition, plasma enhanced chemical vapor deposition, injection molding, compression molding, transfer molding, film forming, thermoforming, vacuum forming, or dipping. 
     
     
         11 . The access port of  claim 1 , wherein the coating combination is biocompatible for at least 10 years. 
     
     
         12 . The access port of  claim 1  wherein the coating combination includes a first layer having conformal and adhesive properties, and a second layer on top of the first layer having biocompatible and biostable properties. 
     
     
         13 . An access port for a gastric band comprising:
 a penetrable septum defining an outer wall of a housing;   a conduit configured to provide fluid communication between the penetrable septum and the gastric band;   a pressure sensor in fluid communication with a fluid within the gastric band; and   a printed circuit board assembly connected to the pressure sensor, wherein the printed circuit board assembly is coated with a coating combination.   
     
     
         14 . The access port of  claim 13 , wherein the coating combination comprises at least two different layers selected from the group consisting of parylene, diamond like carbon, titanium nitride, titanium carbide or silicon nitride, cyclo olefin copolymer, cyclo olefin polymer, epoxy, silicone polymer, glass, chloro-tri-fluoro-ethylene, poly-chloro-tri-fluoro-ethylene, poly-ether-ether-ketone, polysulfone, polyoxymethylene, polypropylene, liquid crystal polymer, ultra high molecular weight polyethylene, fluoropolymer acrylate, and synthetic diamond. 
     
     
         15 . The access port of  claim 13  wherein the coating combination includes a tie layer. 
     
     
         16 . The access port of  claim 15  wherein the coating combination includes a layer formed on top of the tie layer, and which has biocompatible and biostable properties. 
     
     
         17 . The access port of  claim 13  wherein the pressure sensor is coated with the coating combination. 
     
     
         18 . An access port for a gastric band comprising:
 a penetrable septum defining an outer wall of a housing;   a conduit configured to provide fluid communication between the penetrable septum and the gastric band; and   a pressure sensor in fluid communication with a fluid within the gastric band, wherein the pressure sensor is coated with a coating combination.   
     
     
         19 . The access port of  claim 18 , wherein the coating combination comprises at least two different layers selected from the group consisting of parylene, diamond like carbon, titanium nitride, titanium carbide, silicon nitride, cyclo olefin copolymer, cyclo olefin polymer, epoxy, silicone polymer, glass, chloro-tri-fluoro-ethylene, poly-chloro-tri-fluoro-ethylene, poly-ether-ether-ketone, polysulfone, polyoxymethylene, polypropylene, liquid crystal polymer, ultra high molecular weight polyethylene, fluoropolymer acrylate, and synthetic diamond. 
     
     
         20 . The access port of  claim 18  wherein the coating combination includes a tie layer. 
     
     
         21 . The access port of  claim 20  wherein the coating combination includes a layer formed on top of the tie layer, and which has biocompatible and biostable properties. 
     
     
         22 . An implantable medical device comprising:
 an electro-mechanical component coated with a coating combination including a tie layer.   
     
     
         23 . The implantable medical device of  claim 22 , wherein the coating combination comprises at least two different layers selected from the group consisting of parylene, diamond like carbon, titanium nitride, titanium carbide, silicon nitride, cyclo olefin copolymer, cyclo olefin polymer, epoxy, silicone polymer, glass, chloro-tri-fluoro-ethylene, poly-chloro-tri-fluoro-ethylene, poly-ether-ether-ketone, polysulfone, polyoxymethylene, polypropylene, liquid crystal polymer, ultra high molecular weight polyethylene, fluoropolymer acrylate, and synthetic diamond. 
     
     
         24 . The implantable medical device of  claim 22  wherein the coating combination includes a layer formed on top of the tie layer, and which has biocompatible and biostable properties. 
     
     
         25 . A method for protectively coating a long term medical device comprising:
 coating the long term medical device with a tie layer; and   coating the long term medical device with a biostable and biocompatible material.   
     
     
         26 . The method of  claim 25 , wherein the biostable and biocompatible material is selected from a group consisting of parylene, diamond like carbon, titanium nitride, titanium carbide, silicon nitride, cyclo olefin copolymer, cyclo olefin polymer, epoxy, silicone polymer, glass, chloro-tri-fluoro-ethylene, poly-chloro-tri-fluoro-ethylene, poly-ether-ether-ketone, polysulfone, polyoxymethylene, polypropylene, liquid crystal polymer, ultra high molecular weight polyethylene, fluoropolymer acrylate, and synthetic diamond. 
     
     
         27 . The method of  claim 25  further comprising plasma treating the long term medical device. 
     
     
         28 . The method of  claim 25  further comprising coating the long term medical device in a clean room meeting the ISO class 6 ISO 14644-1 clean room standard.