Drug delivery apparatus and method for automatically reducing drug dosage

• US 8,747,390 B2
• Filed: 10/26/2011
• Issued: 06/10/2014
• 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.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US13/281,432
• Publication Number:
  US 20120277732A1
• Time in Patent Office: 958 Days
• Field of Search: 604/890.1, 604/891.1, 604/503, 604/93.01, 604 65- 66
• 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. 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

a controller, carried within the implantable housing, that stores a stored delivery profile including one or more delivery times and one or more delivery rates for the one or more delivery times, controls the fluid transfer device to deliver fluid in accordance with the stored delivery profile, receives modification data that is representative of a reduction rate, and repeatedly reduces all of the one or more delivery rates in the stored delivery profile to iteratively produce and store a plurality of modified delivery profiles which, in a first reduction, have all of the one or more delivery rates in the stored delivery profile reduced in response to a single receipt of modification data and, in each subsequent iterative reduction, have all of the one or more delivery rates in the preceding stored modified delivery profile reduced in response to the single receipt of modification data.

2. An implantable drug delivery device as claimed in claim 1, wherein the stored delivery profile specifies a first delivery time, a first delivery rate for the first delivery time, a second delivery time, and a second delivery rate for the second delivery time, the second delivery rate being different than the first delivery rate.

3. An implantable drug delivery device as claimed in claim 1, wherein the stored delivery profile specifies a plurality of delivery rates, at least two of which are different, for respective portions of a 24-hour period.

4. An implantable drug delivery device as claimed in claim 1, wherein the stored delivery profile comprises a delivery profile for a 24-hour period.

5. An implantable drug delivery device as claimed in claim 1, wherein the one or more delivery rates are defined in terms of pump strokes.

6. An implantable drug delivery device as claimed in claim 1, wherein the modification data comprises a reduction ratio having a value that is less than 1.

7. A fluid drug delivery device as claimed in claim 1, wherein the controller repeatedly reduces the stored delivery profile by (1) reducing all of the one or more delivery rates in the stored delivery profile, (2) maintaining the modified stored delivery profile for a predetermined period, and (3) repeating steps (1) and (2) after the expiration of the predetermined period.

8. A fluid drug delivery device as claimed in claim 7, wherein the predetermined period comprises a period of at least about 2 hours.

9. A fluid drug delivery device as claimed in claim 7, wherein the predetermined period comprises a period of between about 2 hours and about 24 hours.

10. A method, comprising:

repeatedly modifying a stored delivery profile, which includes a plurality of delivery times and a plurality of delivery rates that correspond to the delivery times and is stored within an implantable drug delivery device that is entirely implanted within a body, with the implantable drug delivery device in response to a single receipt by the implantable drug delivery device of wirelessly transmitted modification data that is representative of a reduction rate by

(1) creating a modified delivery profile by reducing the all of the plurality of delivery rates in the stored delivery profile,

(2) storing the modified delivery profile for a predetermined period of at least about 2 hours,

(3) creating a modified delivery profile after the expiration of the predetermined period of at least about 2 hours by reducing all of the plurality of delivery rates in the modified delivery profile stored in step (2), and

(4) repeating steps (2) and (3).

11. A method as claimed in claim 10, 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.

12. A method as claimed in claim 10 wherein the predetermined period is between about 2 hours and about 24 hours.

13. A method as claimed in claim 10, 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 plurality of delivery rates in the stored delivery profile by the reduction ratio.

14. A method as claimed in claim 10, wherein

the step of repeating steps (2) and (3) comprises repeating steps (2) and (3) a plurality of times over the course of more than 24 hours in response to the single receipt of wirelessly transmitted modification data.

15. A method of modifying the dosage of a drug supplied by a drug delivery device that stores a delivery profile including one or more delivery rates 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 all of the one or more delivery rates over the course of more than 24 hours by calculating reduced values for all of the one or more delivery rates in each iteration 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.

16. A method as claimed in claim 15, wherein the final daily dosage value is expressed in terms of volume per time period.

17. A method as claimed in claim 15, wherein the final daily dosage value is expressed in terms of volume per day.

18. A method as claimed in claim 15, wherein the reduction rate is expressed as a percentage reduction per time period or a reduction ratio per time period.

19. A method as claimed in claim 15, wherein the reduction rate is expressed as a percentage reduction per day or a reduction ratio per day.

20. A method as claimed in claim 15, wherein the reduction interval is expressed in days.