Complementary drug delivery sheath for an implantable medical device

Abstract

A complementary drug delivery sheath for implantable medical devices. The complementary drug delivery sheath is covered, impregnated or otherwise carries one or more drugs. The complementary drug-delivery sheaths are manufactured separately from to the implantable device and are operationally combined with the device subsequent to the device's manufacture and/or sterilization. For example, embodiments of the complementary drug-delivery sheaths may be configured, for example, to attain an implanted position adjacent to one or more surfaces of an implantable medical device. In certain embodiments, the sheath is configured in the form of a glove, pocket, pouch, or the like to receive and to partially or completely wrap around or envelop an implantable medical device. Embodiments of the complementary drug delivery sheath may be implanted into the recipient prior to, concurrently with, or subsequent to the implantation of the implantable medical device.

1 . A kit of implantable components for implantation in a recipient, comprising:
 an implantable medical device;   a drug delivery sheath physically separate from the device and configured to be implanted in the recipient proximate to the device, comprising: at least one pannicular substrate configured to be operably positioned adjacent to one or more surfaces of the device subsequent to the device's manufacture, and at least one drug carried on the at least one substrate so as to be released into the recipient.   
     
     
         2 . The kit of  claim 1 , wherein said at least one drug-delivery sheath is configured in the form of a pouch having interior dimensions that enable the pouch to receive and to partially or completely envelop the implantable medical device. 
     
     
         3 . The kit of  claim 1 , wherein the drug-delivery sheath is configured as a pouch that at least partially envelops the implantable medical device. 
     
     
         4 . The kit of  claim 1 , wherein said drug-delivery sheath comprises:
 a top sheath; and   a bottom sheath.   
     
     
         5 . The kit of  claim 4 , wherein said top and bottom sheaths are joined to each other to form a pouch dimensioned to receive the device. 
     
     
         6 . The kit of  claim 1 , wherein one or more exterior dimensions of the drug-delivery sheath approximate a corresponding exterior dimension of the implantable medical device. 
     
     
         7 . The kit of  claim 1 , wherein said drug-delivery sheath is formed of a plurality of pannicular substrates adhered together. 
     
     
         8 . The kit of  claim 7 , wherein two or more of the substrates carry a different drug. 
     
     
         9 . The kit of  claim 1 , wherein the drug-delivery sheath comprises a substrate constructed of a polymeric material in which components of the drug are disposed within the chemical structure of the substrate. 
     
     
         10 . A complementary drug-delivery sheath for implantation into a recipient of an implantable medical device comprising:
 a pannicular substrate having dimensions which enable the sheath to be implanted proximate to one or more surfaces of the device; and   at least one drug carried in the substrate for release into the body of the recipient.   
     
     
         11 . The sheath of  claim 10 , wherein said drug-delivery sheath is configured in the form of a pouch having interior dimensions that enable the pouch to receive and to partially or completely envelop the implantable medical device. 
     
     
         12 . The sheath of  claim 10 , wherein the drug-delivery sheath is configured as a pouch that at least partially envelops the implantable medical device. 
     
     
         13 . The sheath of  claim 10 , wherein said drug-delivery sheath comprises:
 a top sheath; and   a bottom sheath.   
     
     
         14 . The sheath of  claim 13 , wherein said top and bottom sheaths are joined to each other to form a pouch dimensioned to receive the device. 
     
     
         15 . The sheath of  claim 10 , wherein one or more exterior dimensions of the drug-delivery sheath approximate a corresponding exterior dimension of the implantable medical device. 
     
     
         16 . The sheath of  claim 10 , wherein said drug-delivery sheath is formed of a plurality of pannicular substrates adhered together. 
     
     
         17 . The sheath of  claim 16 , wherein two or more of the substrates carry a different drug. 
     
     
         18 . The sheath of  claim 10 , wherein the drug-delivery sheath comprises a substrate constructed of a polymeric material in which components of the drug are disposed within the chemical structure of the substrate. 
     
     
         19 . A method of implanting a medical device, comprising:
 acquiring an implantable medical device; and   acquiring a drug delivery apparatus separate from the implantable medical device; and   implanting the medical device and the drug delivery apparatus, at least one of simultaneously or temporally separately, in the recipient, the method further comprising:
 substantially temporally proximate the implantation of the medical device in the recipient, operably positioning the drug delivery apparatus adjacent to one or more surfaces of the implantable medical device, wherein 
   the drug delivery apparatus includes at least one drug carried thereon so as to be released into the recipient.   
     
     
         20 . The method of  claim 19 , wherein:
 the drug delivery apparatus is a sheath that comprises at least one pannicular substrate;   at least one drug is carried on the at least one substrate so as to be released into the recipient; and   the method further comprising:
 operably positioning the at least one pannicular substrate adjacent to one or more surfaces of the device, wherein 
 the pannicular substrate includes at least one drug carried thereon so as to be released into the recipient.