Device and method for treating conditions of a joint

Abstract

An implantable drug delivery system is provided including a mechanical member attachable to a portion of a body, a first chamber having an opening configured to receive a sustained release device, a sustained release device, and a removably attachable retainer for retaining the sustained release device in the first chamber. A method for administering a drug to a joint is provided including the steps of positioning a mechanical member in or adjacent a bone, the mechanical member configured to hold a sustained release drug delivery device bearing at least one drug, and outputting the at least one drug from the sustained release drug delivery device at a substantially controlled rate. Also provided is a sustained release device intraarticularly implantable into a joint to deliver a therapeutically effective compound within a synovial capsule of the joint such that, in one aspect, the synovial fluid concentration of the compound is greater than the plasma concentration of the compound during the prolonged lifetime of the device, thereby eliminating unwanted systemic side effects and the need for frequent and repeated administrations.

What is claimed is:  
     
         1 . A method for locally administering a therapeutically effective compound to a joint of a mammal, the method comprising the step of: 
 intraarticularly implanting a sustained release device to deliver the therapeutically effective compound within a synovial capsule of the joint such that synovial fluid concentration of the compound is greater than plasma concentration of the compound during substantial lifetime of the device.    
     
     
         2 . The method of  claim 1 , wherein the plasma concentration is substantially non-toxic.  
     
     
         3 . The method according to  claim 1 , wherein the synovial fluid concentration is therapeutic.  
     
     
         4 . The method according to  claim 1 , wherein the device releases the therapeutically effective compound for at least 8 weeks.  
     
     
         5 . The method according to  claim 1 , wherein the device releases the therapeutically effective compound for at least 12 months.  
     
     
         6 . The method according to  claim 1 , wherein the device releases the therapeutically effective compound for about 3 years.  
     
     
         7 . The method according to  claim 1 , wherein the synovial fluid concentration of the compound remains several orders of magnitude greater than the plasma concentration over the lifetime of the device.  
     
     
         8 . The method according to  claim 1 , wherein the therapeutically effective compound is fluocinolone acetonide.  
     
     
         9 . The method according to  claim 1 , wherein the therapeutically effective compound is a cyclosporine.  
     
     
         10 . A method for treating arthritis of joint, the method comprising the step of: 
 intraarticularly implanting a sustained release device into a joint to deliver a therapeutically effective compound within a synovial capsule of the joint such that synovial fluid concentration of the compound is greater than plasma concentration of the compound during substantial lifetime of the device.    
     
     
         11 . An implantable sustained release device for locally administering a drug, the device comprising: 
 a bone screw including a hollow portion configured to receive a sustained release holding device, said sustained release holding device itself configured to receive a drug payload.    
     
     
         12 . An implantable sustained release device in accord with  claim 11 , wherein the sustained release holding device is removably provided within said hollow portion.  
     
     
         13 . An implantable sustained release device in accord with  claim 12 , further comprising: 
 a drug payload including one or more drugs;    a rate-limiting barrier configured to limit a release rate of a drug from the drug payload to thereby provide sustained release of the drug.    
     
     
         14 . An implantable sustained release device in accord with  claim 13 , 
 wherein the rate-limiting barrier is configured to provide a steady-state release rate of a drug from the drug payload substantially equal to a steady-state rate of elimination of the drug from a treatment site, and    wherein the rate-limiting barrier is configured to provide a predetermined therapeutic concentration of the drug in the treatment site, said predetermined therapeutic concentration of the drug being greater than a plasma concentration of the drug until substantially all of the drug in the drug payload is depleted.    
     
     
         15 . A system comprising: 
 a mechanical member attachable to a portion of a body;    a first chamber having an opening configured to receive a sustained release device;    a sustained release device; and    a removably attachable retainer for retaining the sustained release device in the first chamber.    
     
     
         16 . The system according to  claim 15 , wherein the mechanical member is substantially rigid and is configured for at least partial insertion into a bone.  
     
     
         17 . The system according to  claim 16 , wherein the mechanical member comprises a screw.  
     
     
         18 . The system according to  claim 17 , wherein the first chamber is defined within a head of the screw.  
     
     
         19 . The system according to  claim 18 , wherein the sustained release device comprises a drug-bearing insert attachable within said first chamber.  
     
     
         20 . The system according to  claim 19 , wherein the drug-bearing insert is removably attachable within said first chamber by a mechanical fastener.  
     
     
         21 . The system according to  claim 15 , wherein the sustained release device comprises an inner core comprising an effective amount of a low solubility agent; and 
 a non-bioerodible polymer coating layer, the polymer layer being permeable to the low solubility agent, wherein the polymer coating layer covers the inner core and is essentially non-release rate limiting.    
     
     
         22 . The system according to  claim 15 , wherein said removably attachable retainer partially occludes the chamber opening.  
     
     
         23 . A system comprising: 
 a mechanical member attachable to a portion of a body;    a chamber disposed within the mechanical member configured to receive a sustained release device bearing at least one drug; and    an opening in the chamber to permit release of the at least one drug borne by the sustained release device.    
     
     
         24 . The system according to  claim 23 , further comprising a sustained release device configured for placement in said chamber of said mechanical member.  
     
     
         25 . The system according to  claim 24 , wherein the sustained release device comprises an inner core comprising an effective amount of at least one low solubility agent; and 
 a non-bioerodible polymer coating layer, the polymer layer being permeable to the at least one low solubility agent, wherein the polymer coating layer covers the inner core and is essentially non-release rate limiting.    
     
     
         26 . The system according to  claim 25 , wherein the mechanical member is substantially rigid and is configured for at least partial insertion into a bone.  
     
     
         27 . The system according to  claim 26 , wherein the mechanical member comprises a screw.  
     
     
         28 . The system according to  claim 27 , wherein the chamber is defined within a head of the screw.  
     
     
         29 . A method for administering a drug to a joint, the method comprising the step of: 
 positioning a mechanical member in or adjacent a bone, said mechanical member configured to hold a sustained release drug delivery device bearing at least one drug; and    outputting said at least one drug from said sustained release drug delivery device at a substantially controlled rate.    
     
     
         30 . The method of  claim 29 , wherein the drug comprises a steroid.