Adjustable rate drug delivery implantable device

Abstract

Embodiments herein relate to an implantable device comprising a casing, a semi-permeable membrane plug at or near a first end of the casing, a piston, beads, and an opening for release of the beads from the implantable device within a body of a human or an animal; wherein the implantable device is configured to be implanted within the body of the human or the animal during delivery of the beads into the body of the human or the animal; wherein the beads comprise a core and a shell with the core being enclosed by the shell and the beads contain a drug; and wherein the implantable device is configured to produce a desired flow rate of elution of the drug from the implantable device when the implantable device is implanted within the body of the human or the animal.

What is claimed is: 
     
         1 . A system comprising an implantable device and an energy source that produces electricity, the implantable device comprising:
 A. a casing that is substantially tubular and has at least a first end and a second end opposite to the first end,   B. a first chamber,   C. a second chamber comprising a drug,   D. a third chamber,   E. a semi-permeable membrane plug at or near the first end,   F. a piston,   G. a plate with holes therein, and   H. an opening for release of the drug from the implantable device into a body of a human or an animal;   wherein:   a. the implantable device is configured to be implanted within the body of the human or the animal during delivery of the drug into the body of the human or the animal,   b. the piston is located between the semi-permeable membrane plug and the plate,   c. the plate is located between the piston and the second end,   d. the first chamber occupies volume between the semi-permeable membrane plug and the piston,   e. the second chamber occupies volume between the piston and the plate,   f. the third chamber occupies volume between the second chamber and the second end; and   g. the implantable device is configured to produce a desired flow rate of elution of the drug from the implantable device by delivering a consistent drug level through the opening.   
     
     
         2 . The system of  claim 1 , wherein delivery of the consistent drug level by the implantable device comprises a desired dosage cycle. 
     
     
         3 . The system of  claim 1 , wherein depending on a dosing requirement of a particular drug, the implantable device provides over time a constant drug concentration, an increasing drug concentration or a decreasing drug concentration. 
     
     
         4 . The system of  claim 1 , wherein the implantable device provides a constant concentration for a certain amount of time, no drug release for some time, and repeats the constant concentration for the certain amount of time. 
     
     
         5 . The system of  claim 1 , wherein the system delivers the consistent drug level by producing a drug release profile that is either programmed ahead of time or implemented in real-time. 
     
     
         6 . The system of  claim 1 , wherein the desired flow rate of elution the drug is such that a maximum limit and a minimum limit of a concentration of the drug in a blood serum of the human or the animal are Cmax and Cmin, respectively. 
     
     
         7 . The system of  claim 6 , wherein the Cmin and the Cmax are 80% to 125% of a desired concentration of the drug in the body of the human or the animal. 
     
     
         8 . The system of  claim 6 , wherein the Cmin and the Cmax are such that a 90% confidence interval of a peak concentration of the drug in the blood serum of the human or an animal versus a reference is within 80% to 125% of a desired concentration of the reference in the blood serum of the human or the animal, wherein the reference is a product approved by United States Food and Drug Administration. 
     
     
         9 . The system of  claim 1 , wherein the energy source is biocompatible. 
     
     
         10 . The system of  claim 1 , wherein the implantable device comprises the energy source. 
     
     
         11 . The system of  claim 1 , wherein the energy source comprises a battery, a photo-energy source, or a galvanic cell. 
     
     
         12 . The system of  claim 11 , wherein the battery is charged by radio-frequency (RF) charging. 
     
     
         13 . The system of  claim 1 , further comprising an electromagnet and a circuitry. 
     
     
         14 . The system of  claim 1 , further comprising a sensor attached to the implantable device. 
     
     
         15 . The system of  claim 1 , further comprising a sensor that is placed within the body of the human or the animal to measure a drug concentration. 
     
     
         16 . A system comprising (A) a remote control device, (B) an energy source that produces electricity, and (C) an implantable device comprising (i) an osmotic pump comprising a piston, (ii) a drug, and (iii) a plate with holes therein;
 wherein:
 a. the implantable device is configured to be implanted within a body of a human or an animal during delivery of the drug into the body of the human or the animal, and 
 b. the implantable device delivers a consistent drug level through an opening. 
   
     
     
         17 . The system of  claim 16 , wherein delivery of the consistent drug level by the implantable device comprises a dosage cycle. 
     
     
         18 . The system of  claim 16 , wherein depending on a dosing requirement of a particular drug, the implantable device provides over time a constant drug concentration, an increasing drug concentration or a decreasing drug concentration. 
     
     
         19 . The system of  claim 16 , wherein the implantable device provides a constant concentration for a certain amount of time, no drug release for some time, and repeats the constant concentration for the certain amount of time. 
     
     
         20 . A method of treating a disease comprising delivering a drug in a body of a human or an animal using a system comprising (A) a remote control device, (B) an energy source that produces electricity, and (C) an implantable device comprising (i) an osmotic pump comprising a piston, (ii) a drug, and (iii) a plate with holes therein;
 wherein:
 a. the implantable device is configured to be implanted within the body of the human or the animal during delivery of the drug into a body of a human or an animal, and 
 b. the implantable device delivers a consistent drug level through an opening.