Drug Delivery Apparatus and Method for Automatically Reducing Drug Dosage

Abstract

A drug delivery device which includes a fluid drug reservoir, a catheter, a controllable fluid transfer device, e.g., a pump mechanism or valve, and a drug delivery control means. The drug delivery control means comprises a controller, e.g., a microprocessor or microcontroller which is operable to automatically reduce the rate of drug delivery over a certain reduction interval (e.g., multiple days) from an initial dosage value to a final dosage value.

1 - 16 . (canceled) 
   
   
       17 . An implantable drug delivery device, comprising:
 an implantable housing configured for implantation into a body;   a reservoir within the implantable housing;   a fluid transfer device within the implantable housing in fluidic communication with the reservoir; and   means, carried within the implantable housing, for repeatedly modifying an entire stored delivery profile including at least one delivery rate in response to a single receipt of modification data.   
   
   
       18 . An implantable drug delivery device as claimed in  claim 17 , wherein the stored delivery profile includes at least two different delivery rates. 
   
   
       19 . An implantable drug delivery device as claimed in  claim 17 , wherein the stored delivery profile includes a plurality of delivery rates, at least two of which are different, that are associated with respective portions of a 24-hour period. 
   
   
       20 . An implantable drug delivery device as claimed in  claim 17 , wherein the stored delivery profile comprises a delivery profile for a 24-hour period. 
   
   
       21 . An implantable drug delivery device as claimed in  claim 17 , wherein the at least one delivery rate is defined in terms of pump strokes. 
   
   
       22 . An implantable drug delivery device as claimed in  claim 17 , wherein the modification data comprises a reduction ratio having a value that is less than 1. 
   
   
       23 . A method of operating an implantable drug delivery device, comprising the step of:
 repeatedly modifying a delivery profile that includes a plurality of delivery rates and is stored within the implantable drug delivery device with the implantable drug delivery device in response to a single receipt of wirelessly transmitted modification data.   
   
   
       24 . A method as claimed in  claim 23 , further comprising the step of:
 receiving wirelessly transmitted modification data with the implantable drug delivery device while the entire implantable drug delivery device is carried within a patient's body.   
   
   
       25 . A method as claimed in  claim 23 , wherein the step of repeatedly modifying a stored delivery profile comprises performing the following steps with the implantable drug delivery device in response to a single receipt of wirelessly transmitted modification data:
 (1) creating a modified delivery profile by reducing the delivery rates in the stored delivery profile,   (2) storing the modified delivery profile for a predetermined period, and   (3) repeating steps (1) and (2) after the expiration of the predetermined period.   
   
   
       26 . A method as claimed in  claim 25 , wherein the predetermined period is at least about 2 hours. 
   
   
       27 . A method as claimed in  claim 25 , wherein the predetermined period is between about 2 hours and about 24 hours. 
   
   
       28 . A method as claimed in  claim 25 , wherein
 the modification data comprises a reduction ratio having a value less than 1.0; and   the step of creating a modified delivery profile comprises multiplying the delivery rates in the delivery profile by the reduction ratio.   
   
   
       29 . A method as claimed in  claim 25 , wherein
 the step of repeating steps (1) and (2) comprises repeating steps (1) and (2) after the expiration of the predetermined period a plurality of times over the course of a plurality of days in response to a single receipt of wirelessly transmitted modification data.   
   
   
       30 . A method of modifying the dosage of a drug supplied by a drug delivery device that stores a delivery profile including at least one delivery rate and is located entirely within a patient, the method comprising the steps of:
 wirelessly transmitting a final daily dosage value to the drug delivery device located entirely within the patient;   wirelessly transmitting a reduction rate or a reduction interval to the drug delivery device located entirely within the patient; and   allowing the drug delivery device located entirely within the patient to itself iteratively reduce the at least one delivery rate over the course of a plurality of days as a function of the transmitted final daily dosage value and the transmitted reduction rate or as a function of the transmitted final daily dosage value and the transmitted reduction interval.   
   
   
       31 . A method as claimed in  claim 30 , wherein the final dosage value is expressed in terms of volume per time period. 
   
   
       32 . A method as claimed in  claim 30 , wherein the final dosage value is expressed in terms of volume per day. 
   
   
       33 . A method as claimed in  claim 30 , wherein the reduction rate is expressed as a percentage reduction per time period or a reduction ratio per time period. 
   
   
       34 . A method as claimed in  claim 30 , wherein the reduction rate is expressed as a percentage reduction per day or a reduction ratio per day. 
   
   
       35 . A method as claimed in  claim 30 , wherein the reduction interval is expressed in days. 
   
   
       36 . A method of operating an implantable drug delivery device, comprising the steps of:
 initiating a dosage reduction mode in response to a single event; and   modifying a delivery profile that includes one or more clinically significant delivery rates and is stored within the implantable drug delivery device by reducing the one or more clinically significant delivery rates to one or more lower clinically significant delivery rates with the implantable drug delivery device in response to the initiation of the dosage reduction mode.   
   
   
       37 . A method as claimed in  claim 36 , where in the step of initiating a dosage reduction mode comprises initiating a dosage reduction mode in response to a single receipt of wirelessly transmitted modification data. 
   
   
       38 . A method as claimed in  claim 36 , where in the step of modifying a delivery profile comprises repeatedly modifying a delivery profile that includes one or more clinically significant delivery rates and is stored within the implantable drug delivery device by reducing the one or more clinically significant delivery rates to one or more lower clinically significant delivery rates with the implantable drug delivery device in response to the initiation of the dosage reduction mode. 
   
   
       39 . A method as claimed in  claim 36 , where in the step of modifying a delivery profile comprises modifying a delivery profile that includes a plurality of clinically significant delivery rates and is stored within the implantable drug delivery device by reducing the plurality of clinically significant delivery rates to a plurality of lower clinically significant delivery rates with the implantable drug delivery device in response to the initiation of the dosage reduction mode.