CONTROLLABLE DRUG DELIVERY DEVICE

• US 20100087778A1
• Filed: 10/22/2009
• Published: 04/08/2010
• Est. Priority Date: 04/23/2007
• Status: Active Grant

• Current Assignee: United Therapeutics Corporation
• Original Assignee: SteadyMed Ltd. (United Therapeutics Corporation)
• Inventors: Goldstein, Jonathan, Aldar, Yossi, Bachar, Yehuda, Fleisher, Niles A., Genosar, Amir
• Granted Patent: US 7,918,843 B2
• Time in Patent Office: Days
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2205/0272 Electro-active or magneto-active materials
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/1486 the bags being substantially completely surrounded by fluid

Abstract

A controllable drug delivery device for delivering a liquid injectable drug, said device comprising a drug reservoir (22), a drug administration device (28), a displacement-generating battery (20), and a current-depletion circuit (85), wherein displacement generated by said battery as current is depleted from the battery by the current depletion circuit displaces a wall of the drug reservoir thereby causing the reservoir to expel liquid injectable drug contained therein via said drug administration device, and wherein the drug delivery device further includes a controller (78) that is responsive to a measured parameter indicative of displacement generated by the battery for applying a variable load (80) across the battery in order to provide a substantially constant-current depletion of said battery and thereby cause said drug delivery device to deliver a substantially constant drug delivery rate.

Claims

1. A controllable drug delivery device for delivering a liquid injectable drug, said device comprising:

a drug reservoir;

a drug administration device;

a displacement-generating battery;

a displacement sensor for producing a signal indicative of the actual displacement produced by said battery;

a current-depletion circuit;

a controller for applying a variable load across said battery; and

a battery status unit coupled to the battery for determining at least one property of said battery that is indicative of battery displacement;

wherein displacement generated by said battery under the control of said controller as current is depleted from the battery by the current depletion circuit displaces a wall of the drug reservoir thereby causing the reservoir to expel liquid injectable drug contained therein via said drug administration device,

the inputs to said controller include both the displacement sensor and the battery status unit, such that two independent indications of the displacement achieved are available to said controller;

the controller is responsive to a discrepancy between said two indications for determining that a malfunction has occurred, and

the controller provides a substantially constant-current depletion of the battery and thereby causes said drug delivery device to deliver a substantially constant drug delivery rate.

2. The drug delivery device of claim 1, wherein the properties of the battery determined by the battery status unit include internal resistance and accumulated discharge.

3. The drug delivery device of claim 1, where the drug delivery rate is calculated according to accumulated charge depletion from said battery.

4. The device according to claim 1, wherein the current depletion circuit is adapted to vary a duty cycle of a switch so as to vary a mean current passed thereby.

5. The device according to claim 1, wherein:

the current depletion circuit includes a bipolar junction transistor having a collector and emitter coupled across the battery, and

the controller is adapted to apply a controlled bias voltage to a base of the bipolar junction transistor for varying an effective output impedance of the bipolar junction transistor.

6. The device according to claim 1, wherein the displacement sensor includes a strain gauge.

7. The device according to claim 1, wherein the displacement sensor is adapted to measure capacitance between a pair of electrically conductive plates disposed on opposite sides of the drug reservoir.

8. The device according to claim 1, wherein the current-depletion circuit is settable between different depletion rates in order to generate different drug delivery rates.

9. The device according to claim 1, wherein the controller is adapted to set lock-outs between boluses.

10. The device according to claim 1, wherein the battery operates based on intercalation between two metals.

11. The device according to claim 1, wherein the battery contains an electrochemical cell that is fluidly coupled to a bellows and, on expansion of the cell, fluid is forced out of the cell into the expanding wall thus causing the expanding wall to expand.

12. The device according to claim 11, wherein the fluid is a hydraulic fluid.

13. The device according to claim 11, wherein the fluid is electrolyte.

14. The device according to claim 1, wherein the battery is a thin-film battery.

15. The device according to claim 1, wherein the battery provides sufficient pressure to deliver drugs in viscosity range 20-200 centipoise.

16. The device according to claim 1, wherein the drug reservoir includes a flexible pouch.

17. The device according to claim 1, wherein the drug administration device comprises a cannula and an associated insertion mechanism.

18. The device according to claim 16, wherein the cannula insertion mechanism is at least partially mounted in parallel with the battery.

19. The device according to claim 1, wherein the drug administration device comprises at least one microneedle.