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Claims for Patent: 8,983,594

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Claims for Patent: 8,983,594

Title:Electronic control of drug delivery system
Abstract: In an exemplary embodiment, a drug delivery device for driving an electrotransport current through a body surface of a user is provided. The device includes a patch with two electrodes and one or more reservoirs storing a therapeutic agent. The one or more reservoirs release the therapeutic agent into the body surface of the user when the reservoirs are positioned over the electrodes to form an electrical path for the electrotransport current. The device includes a controller which controls a controllable power supply to drive the electrotransport current through the body surface of the user in a predetermined profile.
Inventor(s): Saar; David (Titusville, NJ), Baudis; Bogdan Mariusz (Stoneham, MA), Gupta; Rainuka (Cambridge, MA), Kamat; Vaishali Vilas (Arlington, MA), Reich; Matthew Kent (Medford, MA), Srinivasan; Rajagopalan (Cambridge, MA)
Assignee: NuPathe, Inc. (Malvern, PA)
Application Number:12/648,726
Patent Claims: 1. A drug delivery device for driving an electrotransport current through an animal body surface, the device comprising: a patch comprising: two electrodes; and one or more reservoirs storing a therapeutic agent, the one or more reservoirs releasing the therapeutic agent through the animal body surface when the one or more reservoirs are positioned over the electrodes to form an electrical path for the electrotransport current traveling from one of the electrodes to the other of the electrodes; a controllable power supply for: applying an output voltage across the animal body surface; and driving the electrotransport current through the animal body surface; and a controller programmed to: determine a present value of the electrotransport current; determine a dynamic value representative of a target electrotransport current, the dynamic value determined based on the target electrotransport current, a resistance value of a sense resistor used to detect the electrotransport current flowing between the electrodes, a value of a bandgap voltage associated with the controller, and a fixed voltage value; and control the controllable power supply at least based on the present value of the electrotransport current and the dynamic value representative of the target electrotransport current.

2. The device of claim 1, wherein the controller controls the controllable power supply using a linear regulator.

3. The device of claim 2, wherein the controller is further programmed to: shut down the device upon detecting a potential safety issue; and provide an indication that the device has been shut down.

4. The device of claim 1, wherein the controller controls the controllable power supply using a switching regulator.

5. The device of claim 4, wherein the switching regulator performs pulse width modulation (PWM) and the controllable power supply is a PWM power supply.

6. The device of claim 5, wherein the controller is programmed to: control a duty cycle of the PWM power supply at least based on the present value of the electrotransport current and the dynamic value representative of the target electrotransport current.

7. The device of claim 5, wherein the controller is further programmed to: determine the present value of the electrotransport current and the dynamic value representative of the target electrotransport current at predetermined intervals using a timer.

8. The device of claim 5, wherein the controller is further programmed to: determine a present value of the output voltage; determine a dynamic value representative of a target output voltage; perform a first comparison between the present value of the output voltage and the dynamic value representative of the target output voltage; perform a second comparison between the present value of the electrotransport current and the dynamic value representative of the target electrotransport current; and control a duty cycle of the PWM power supply based on the first comparison or the second comparison.

9. The device of claim 8, wherein control of the duty cycle of the PWM power supply further comprises: determining that the present value of the output voltage is greater than the dynamic value representative of the target output voltage based on the first comparison; and reducing the duty cycle of the PWM power supply by one step without performing an electrotransport current correction.

10. The device of claim 8, wherein control of the duty cycle of the PWM power supply further comprises: determining that the present value of the output voltage is less than or equal to the dynamic value representative of the target output voltage based on the first comparison; and performing an electrotransport current correction based on the second comparison.

11. The device of claim 10, wherein performing the electrotransport current correction comprises: determining that the present value of the electrotransport current is greater than the dynamic value representative of the target electrotransport current based on the second comparison; and reducing the duty cycle of the PWM power supply by one step.

12. The device of claim 10, wherein performing the electrotransport current correction comprises: determining that the present value of the electrotransport current is equal to the dynamic value representative of the target electrotransport current based on the second comparison; and maintaining the duty cycle of the PWM power supply at its present step.

13. The device of claim 10, wherein performing the electrotransport current correction comprises: determining that the present value of the electrotransport current is less than the dynamic value representative of the target electrotransport current based on the second comparison; and increasing the duty cycle of the PWM power supply by one step.

14. The device of claim 1, wherein the patch and a power supply are separable.

15. The device of claim 1, wherein the controller is further programmed to: detect if there is a minimum level of energy in a power supply of the device; and drive the electrotransport current through the animal body surface only if the power supply has the minimum level of energy.

16. The device of claim 1, wherein the controller is re-programmable to drive the electrotransport current through the animal body surface in a second predetermined profile.

17. The device of claim 1, wherein the controller is further programmed to: maintain the output voltage below a maximum level irrespective of changes in the resistance of the animal body surface.

18. The device of claim 1, wherein the device is configured for a single use, and wherein the controller is programmed to slowly drain a power supply at the end of dosing of the therapeutic agent.

19. The device of claim 1, wherein the dynamic value representative of the target electrotransport current is determined based at least on the target electrotransport current and an operational characteristic of a power supply that varies during operation of the power supply.

20. The device of claim 19, wherein the operational characteristic of the power supply is a variable output voltage of the power supply.

21. The device of claim 19, wherein the dynamic value representative of the target electrotransport current is determined based at least on the target electrotransport current and a reference voltage at an analog-to-digital converter that varies during operation of the power supply.

22. A method of delivering a drug to a user, the method comprising administering the drug using the device of claim 1.

23. A method of treating a user, the method comprising transdermally administering to the user an effective amount of a drug, wherein the drug is administered using the device of claim 1.

24. The method according to any of claims 22-23, wherein the drug is a triptan compound.

25. A method of treating a triptan compound responsive state in a user, the method comprising transdermally administering to the user an effective amount of a triptan compound, wherein the triptan compound is administered using the device of claim 1.

26. The method according to claim 25, wherein the triptan compound responsive state is at least one state selected from the group consisting of migraines, familiar hemiplegic migraines (with and without aura), chronic paroxysmal headaches, cluster headaches, migraine headaches, basilar migraines, and atypical headaches accompanied by autonomic symptoms.

27. The method according to claim 26, wherein the triptan compound is sumatriptan succinate.
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