Drug-delivery pump with intelligent control

• US 9,849,238 B2
• Filed: 09/24/2013
• Issued: 12/26/2017
• Est. Priority Date: 05/08/2008
• Status: Expired due to Fees

• Current Assignee: MiniPumps, LLC
• Original Assignee: MiniPumps, LLC
• Inventors: Li, Po-Ying, Li, Shengtao, Lee, Jonathan K., Ryan, Patrick, Lai, Alice, Caffey, Sean, Humayun, Mark S.
• Primary Examiner(s): Vu, Quynh-Nhu H
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US14/035,702
• Publication Number:
  US 20140094770A1
• Time in Patent Office: 1,554 Days
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2205/0222 Materials for reducing friction
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3341 stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8231 using electrochemical gas generating device for the driving gas
• CPC Class Codes: A61M 2205/8293 Solar
• 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 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/14586 : pressurised by means of a flexible diaphragm
• 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 5/155 : pressurised by gas introduced into the reservoir
• CPC Class Codes: A61M 5/16804 : Flow controllers
• CPC Class Codes: A61M 5/16809 : by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• 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: A61M 5/3146 : Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

Embodiments of the present invention utilize a closed-loop feedback control system to ensure accurate drug delivery. This control system may, for example, utilize a flow sensor to measure the volume of delivery and an intelligent control algorithm to anticipate and compensate for overdoses and underdoses. Feedback control systems in accordance herewith can be applied to any piston- or plunger-driven pump system utilizing sensors that measure flow directly or indirectly. In some embodiments, adjustments are made during a “priming” stage when liquid is pumped through the internal fluid path but does not exit the pump.

Claims

1. A drug pump device comprising:

a drug reservoir containing a fluid;

an exit member for fluidically connecting the reservoir with a drug injection site;

a sensor;

an electrolysis pump comprising a pump chamber in mechanical communication with the drug reservoir via an intervening displacement member, the electrolysis pump being operable to exert a pressure to drive the intervening displacement member toward the exit member and thereby force therethrough the fluid in the drug reservoir; and

control circuitry for (i) storing one or more delivery parameters and target values therefor, (ii) operating the electrolysis pump in a priming stage to force a volume of the fluid from the drug reservoir into the exit member but substantially before any delivery of fluid from the exit member, (iii) based on signals received from the sensor during the priming stage before substantially any delivery of fluid from the exit member, determining a deviation between a target value of one or more delivery parameters and a measured value thereof for delivery of a target volume of fluid, and (iv) based at least in part on the determined deviation, operating the pump in a delivery stage to force the target volume of fluid from the drug reservoir out through the exit member.

2. The device of claim 1, wherein the sensor is at least one pressure sensor.

3. The device of claim 1, wherein the sensor is at least one flow sensor.

4. The device of claim 1, wherein the sensor comprises at least one flow sensor and at least one pressure sensor.

5. The device of claim 1, wherein the one or more delivery parameters are at least one of flow volume or flow rate.

6. The device of claim 1, wherein the measured value is obtained directly or indirectly from the sensor signals.

7. The device of claim 1, wherein the electrolysis pump is operable to force fluid from the drug reservoir into the exit member in pulses having time windows each defined by a pump-start time when pumping begins and a pump-stop time when the pump is shut off, the control circuitry being configured to operate the pump during the time windows at a maximum dosing and to adjust the time window during the delivery stage based at least in part on the deviation determined during the priming stage in order to force the target volume of fluid from the drug reservoir out through the exit member.

8. The device of claim 7, wherein at least one pulse corresponds to a non-therapeutic dose.

9. The device of claim 7, wherein the one or more delivery parameters is flow volume, the measured flow volume including a pulse volume expelled during the pulse and an additional tail volume expelled after the pulse, the determined deviation corresponding to the tail volume.

10. The device of claim 1, wherein the control circuitry causes delivery of a single bolus during the delivery stage.

11. The device of claim 1, wherein the target volume of fluid from the drug reservoir is dispensed through the exit member over a sequence of time-separated pulses occurring over a time interval.

12. The device of claim 1, wherein the intervening displacement member comprises a piston, a diaphragm, a bladder, or a plunger.

13. A method of controlling an actual delivery volume of fluid in a drug pump device comprising a drug reservoir containing a fluid, an exit member for fluidically connecting the reservoir with a drug injection site, and an electrolysis pump operable to exert a pressure to drive the displacement member toward the exit member and thereby force therethrough the fluid in the drug reservoir to conform to a target delivery volume, the method comprising:

operating the electrolysis pump in a priming stage to force a volume of the fluid from the drug reservoir into the exit member but substantially before any delivery of fluid from the exit member;

during the priming stage before substantially any delivery of fluid from the exit member, receiving signals from a sensor and, based thereon, determining a deviation between an expected value of one or more delivery parameters and a measured value thereof for delivery of the target delivery volume; and

based at least in part on the determined deviation, operating the pump in a delivery stage to force the target delivery volume of fluid from the drug reservoir out through the exit member.

14. The method of claim 13, wherein the one or more delivery parameters are at least one of flow volume or flow rate.

15. The method of claim 14, wherein the one or more delivery parameters is flow volume, the measured flow volume including a pulse volume expelled during the pulse and an additional tail volume expelled after the pulse, the determined deviation corresponding to the tail volume.

16. The method of claim 13, wherein fluid is forced from the drug reservoir into the exit member in pulses having time windows each defined by a pump-start time when pumping begins and a pump-stop time when the pump is shut off, the pump being operated during the time windows at a maximum dosing rate, the time window during the delivery stage being adjusted based at least in part on the deviation determined during the priming stage in order to force the target volume of fluid from the drug reservoir out through the exit member.

17. The method of claim 16, wherein at least one pulse corresponds to a non-therapeutic dose.

18. The method of claim 13, wherein a single bolus is expelled during the delivery stage.

19. The method of claim 13, wherein the target delivery volume is dispensed through the exit member over a sequence of time-separated pulses occurring over a time interval.