Drug Delivery Apparatus and Method for Automatically Reducing Drug Dosage

• US 20120277732A1
• Filed: 10/26/2011
• Published: 11/01/2012
• Est. Priority Date: 08/27/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medallion Therapeutics, Inc.
• Inventors: Shelton, Brian M.
• Granted Patent: US 8,747,390 B2
• Time in Patent Office: Days
• US Class Current: 604/891.1
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

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.

Claims

1. A fluid drug delivery device comprising:

a reservoir for storing a fluid;

a catheter for transferring fluid from said reservoir to a selected body site, said catheter having a proximal end for receiving fluid from said reservoir and a distal end for delivering fluid to said body site;

a controllable fluid transfer device coupling said reservoir to said catheter proximal end;

a controller storing data defining a delivery rate specifying a quantity of fluid to be delivered to said catheter within a specified period;

a source of modification data;

said controller being responsive to said modification data for iteratively modifying said stored delivery rate; and

wherein

said fluid transfer device is responsive to said modified delivery rate for delivering a specified quantity of fluid to said catheter proximal end.

2. The delivery device of claim 1 wherein said controller includes a programmable microprocessor;

and wherein

said controller includes means for executing an algorithm to iteratively reduce said stored delivery rate based on said modification data.

3. The combination of claim 1 wherein said drug delivery device comprises an implantable pump;

and further including

a clinician operable programmer external to said drug delivery device for transmitting said modification data.

4. The combination of claim 3 wherein said drug modification data defines a periodic reduction ratio;

and wherein

said controller iteratively processes the stored delivery rate and said reduction ratio to produce a modified delivery rate.

5. The combination of claim 4 wherein said reduction ratio has a value less than one;

and wherein

said controller processing includes multiplying the stored delivery rate times said reduction ratio.

6. The combination of claim 4 wherein said modification data defines a periodic reduction ratio having a value less than one;

and wherein

said controller stores a current delivery profile defining at least one delivery rate; and

wherein

said controller operates to iteratively multiply said periodic reduction ratio times each delivery rate in said current delivery profile to produce a new delivery profile.

7. The combination of claim 1 wherein said modification data specifies a number of periodic reduction steps and a reduction ratio having a value less than one;

and wherein

said controller multiplies said stored delivery rate and said reduction ratio for each of said reduction steps to successively produce new and reduced delivery values.

8. A method of operating an implantable drug delivery device for transferring a drug from a reservoir to a catheter for delivery to a body site, said method including:

providing said reservoir with a first drug;

storing a current dosage value;

generating dosage modification data;

periodically modifying said stored dosage value in accordance with said dosage modification data; and

controllably transferring said first drug from said reservoir to said catheter in accordance with the currently stored dosage value.

9. The method of claim 8 wherein said step of periodically modifying comprises iteratively reducing said stored dosage value.

10. The method of claim 8 wherein said step of generating dosage modification data includes calculating a rate reduction ratio;

and wherein

said step of periodically modifying comprises iteratively multiplying said stored dosage valve times said reduction ratio.

11. A fluid drug delivery system comprising:

an implantable drug delivery pump including a controller for transferring a fluid drug from said pump at delivery rates defined by a stored drug delivery profile;

an external programmer for generating drug delivery modification data; and

wherein

said controller includes means responsive to said drug modification data for iteratively modifying said defined delivery rates as a function of said modification data.

12. The system of claim 11 wherein said modification data specifies a discrete number of modification steps and a modification ratio for each of said steps;

and wherein

for each of said steps said controller modifies the stored drug delivery profile as a function of said modification ratio to successively define modified delivery rates.

13. The system of claim 12 wherein said modification data specifies a discrete number of reduction steps and a reduction ratio for each of said steps having a value less than one;

and wherein

for each of said steps said controller modifies the stored drug delivery profile as a function of said reduction ratio to successively define reduced delivery rates.

14. The system of claim 13 wherein said programmer includes processor means for calculating said reduction ratio.

15. The system of claim 14 further including telemetry means for communicating said calculated reduction ratio to said pump controller.

16. The system of claim 11 wherein said drug delivery pump further includes a fluid reservoir and a fluid transfer means for transferring fluid from said reservoir to a patients body site;

and wherein

said controller controls said fluid transfer means in accordance with said defined delivery rates.