Drug-delivery pumps with dynamic, adaptive control

• US 9,199,035 B2
• Filed: 08/18/2010
• Issued: 12/01/2015
• Est. Priority Date: 05/08/2008
• Status: Active Grant

• Current Assignee: MiniPumps, LLC
• Original Assignee: MiniPumps, LLC
• Inventors: Shih, Jason, Brennan, Jeffrey, Jiang, Fukang, Caffey, Sean
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US12/858,808
• Publication Number:
  US 20110202032A1
• Time in Patent Office: 1,931 Days
• Field of Search: 604/891.1, 604/890.1, 604/67
• US Class Current: 1/1
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

In various embodiments, actuation of a drug-delivery pump is controlled based on a change in a condition of the pump.

Claims

1. A drug-delivery pump operating at period time intervals, comprising:

a drug reservoir configured to hold a liquid drug;

a cannula for conducting the liquid drug from the reservoir to a target site;

a pump actuator comprising electrolysis electrodes driven by a current for forcing the liquid drug from the reservoir through the cannula;

at least one physical sensor for measuring at least one quantitative electrical or flow pump operating parameter;

a memory for storing (i) a fixed dosage of the liquid drug to be delivered by the pump actuator through the cannula during each of a plurality of dosing intervals and (ii) a value of the at least one quantitative pump operating parameter measured by the at least one physical sensor obtained during a previous at least one dosing intervals interval, the pump actuator being operative during the previous dosing interval to deliver the fixed dosage; and

circuitry for controlling the current supplied to the pump actuator by computing actuator settings based at least in part on the stored fixed dosage and a change in a condition of the pump actuator specified by a quantitative difference between the stored value of the pump operating parameter and a current value of the pump operating parameter, and adjusting the pump actuator in accordance with the computed actuator settings to thereby compensate for the change in a maximum flow rate reached while the current is supplied to the actuator pump in the current dosing interval or an amount of liquid delivered due to residual pressure after the current is no longer supplied to the actuator pump in the current dosing interval.

2. The pump of claim 1, wherein the circuitry maintains delivery of the fixed dosage of the liquid drug at periodic time intervals to the target site.

3. The pump of claim 1 further comprising a flow sensor for measuring a flow rate of the liquid drug through the cannula.

4. The pump of claim 3, wherein the circuitry controls the pump actuator based, at least in part, on an analysis of the flow rate.

5. The pump of claim 4, wherein the circuitry further controls the pump actuator based on real-time data from the pump actuator.

6. The pump of claim 1, wherein the pump actuator further comprises:

an electrolyte chamber;

an expandable diaphragm separating the chamber and the drug reservoir and providing a fluid barrier therebetween; and

the electrolysis electrodes for causing evolution of a gas in the electrolyte chamber to thereby expand the expandable diaphragm so that the liquid drug is forced from the drug reservoir into the cannula.

7. The pump of claim 6, wherein diaphragm expansion is adjusted by varying actuation current supplied to the electrolysis electrodes.

8. The pump of claim 6, wherein diaphragm expansion is adjusted by varying an actuation duration of the electrodes.

9. The pump of claim 6, wherein the electrolysis electrodes are driven with a constant current.

10. The pump of claim 6, wherein the electrolysis electrodes are driven with a time-varying current waveform.

11. The pump of claim 1, wherein the circuitry is configured to store values of the at least one pump operating parameter in the memory at each of the plurality of dosing intervals.

12. The pump of claim 1, wherein each of the at least one pump operating parameter is a flow-related parameter selected from the group consisting of (i) the current flowing through the electrolysis electrode of the actuator pump, (ii) a maximum flow rate of the liquid drug through the cannula, (iii) a variation in flow patterns of the liquid drug through the cannula, (iv) an actuation time required for the pump to achieve a particular flow rate of the liquid drug through the cannula, (v) a time required for a flow of the liquid drug to ramp down from a particular flow rate to a flow rate of zero, (vi) a time delay between an initial actuation of the pump actuator and an initial flow of liquid drug through the cannula, (vii) an efficiency of the pump actuator, (viii) an internal pressure of the drug reservoir, (ix) an acceleration experienced by the pump actuator, (x) a resistance of a flow sensor, and (xi) at least one physical dimension of the pump actuator, the drug reservoir, or the cannula.

13. The drug-delivery pump of claim 12, wherein the efficiency of the pump actuator is determined based at least in part on an amount of charge pumped through the pump actuator and an amount of gas generated by the electrolysis electrodes.

14. The drug-delivery pump of claim 1, wherein the at least one quantitative electrical or flow pump operating parameter is obtained by direct measurement.

15. The drug-delivery pump of claim 1, wherein the circuitry is configured to control the pump actuator to maintain a target dosage level.

16. The drug-delivery pump of claim 1, wherein the circuitry adjusts the pump actuator to continue delivering the fixed dosage during the current dosing interval.

17. The drug-delivery pump of claim 1, wherein the computed actuator settings comprises an actuation time required for the pump actuator to achieve a particular flow rate of the liquid drug through the cannula, and a flow profile of the pump actuator resulting from activation of the pump actuator in accordance with the computed actuator settings comprises a time required for a flow of the drug to ramp down from a particular flow rate to a flow rate of zero.

18. A drug-delivery pump comprising:

a drug reservoir configured to hold a liquid drug;

a cannula for conducting the liquid drug from the reservoir to a target site;

a pump actuator comprising electrolysis electrodes driven by a current for forcing the liquid from the reservoir through the cannula during a plurality of dosing cycles;

at least one physical sensor for measuring at least one quantitative electrical or flow pump operating parameter;

a memory for storing (i) a fixed dosage to be delivered by the pump actuator through the cannula during each of a plurality of different dosing cycles and (ii) values of the at least one quantitative electrical or flow pump operating parameter measured by the at least one physical sensor obtained during each of the plurality of different dosing cycles, the pump actuator being operative during each of the plurality of different dosing cycles to deliver the fixed dosage; and

circuitry for adaptively controlling the current supplied to the pump actuator by computing actuator settings for a new dosing cycle based at least in part on the stored fixed dosage and a change in the values between the plurality of different dosing cycles stored in the memory, and adjusting the pump actuator in accordance with the computed actuator settings to thereby compensate for a change in a maximum flow rate reached while the current is supplied to the actuator pump or an amount of liquid delivered due to residual pressure after the current is no longer supplied to the actuator pump.