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Claims for Patent: 9,364,656

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Claims for Patent: 9,364,656

Title:Method of storing an electrotransport drug delivery device
Abstract: A switch operated therapeutic agent delivery device is described. The device comprises two parts, which are assembled by a user prior to use. A first part contains a power supply and circuitry for the device; and a second part comprises electrodes and reservoirs containing the therapeutic agent to be delivered. The action of combining the two parts of the device causes the two parts to be irreversibly coupled together, completes an electrical connection between the two parts, and closes one or more switches, thereby connecting a power source, such as a battery, into the device's circuitry, thereby powering the device on so that it is ready for use. The device can then be attached to a patient, who can operate the device by pressing a button in a proper sequence.
Inventor(s): Netzel; Zita S. (Los Altos, CA), Lemke; John (Pleasanton, CA), Seward; David (Seattle, WA), Read; Brian W. (Brier, WA), White; Bradley E. (Lebanon, OH), Chen; Corinna X. (Oakland, CA), Hayter; Paul (Mountain View, CA)
Assignee: Incline Therapeutics, Inc. (Redwood City, CA) Alza Corporation (Vacaville, CA)
Application Number:14/002,909
Patent Claims: 1. A method of storing an electrotransport drug delivery device to resist corrosion prior to use, the method comprising: separately storing an electrical module and a reservoir module, so that circuitry in the electrical module is electrically isolated from a power source in the electrical module by a power-on contact between the circuitry and the power source when the electrical module is separated from the reservoir module, wherein the power source is isolated from the circuitry by the power-on contact while the power-on contact is open; combining the electrical module and the reservoir module to form a unitary drug delivery device by connecting the circuitry via an electrical output to an input connector on the reservoir module, wherein combining the electrical module and the reservoir module causes battery contact actuators on the reservoir module to close the power-on contact allowing the power source to power the circuitry; and electrically connecting the circuitry in the electrical module to at least a pair of active electrodes in the reservoir module when the electrical module is combined with the reservoir module.

2. The method of claim 1, further comprising forming a seal upon combining the electrical module and the reservoir module.

3. The method of claim 2, wherein forming the seal comprises forming a seal that is water- and/or particulate-tight.

4. The method of claim 1, further comprising forming a seal around the input connector and the electrical output when the electrical module and the reservoir module are combined to form the unitary device.

5. The method of claim 1, wherein separately storing the electrical module and the reservoir module comprises storing the electrical module so that circuitry in the electrical module is electrically isolated from the power source by two or more power-on contacts between the circuitry and the power source.

6. The method of claim 1, wherein separately storing the electrical module and reservoir module comprises storing the electrical module so that the power-on contact is sealed water- and/or particulate-tight.

7. The method of claim 1, further comprising maintaining a seal over each power-on contact in the electrical module when the power-on contact is closed by the battery contact actuator.

8. The method of claim 1, wherein combining the electrical module and the reservoir module to cause the battery contact actuators on the reservoir module to close the power-on contact comprises deforming a flexible polymer seal over the power-on contact with the battery contact actuator when the electrical module is combined with the reservoir module, whereby the battery contact actuator mechanically acts through the seal to close the power-on contact.

9. The method of claim 1, further comprising maintaining a seal sealing the electrical output before, during, and after the electrical module is combined with the reservoir module.

10. The method of claim 1, further comprising coupling a coupler on the reservoir module or the electrical module with a corresponding coupler receptor on the electrical module or reservoir module, respectively, to maintain the connection between the electrical module and reservoir module.

11. The method of claim 10, wherein coupling the coupler comprises coupling a snap that is mechanically biased to snap into a corresponding snap receptor.

12. The method of claim 11, wherein coupling the coupler comprises coupling a one-way snap.

13. The method of claim 1, wherein combining the electrical module and the reservoir module comprises combining the electrical module and the reservoir module in a particular orientation determined by the configuration of the electrical module and the reservoir module.

14. The method of claim 1, wherein combining the electrical module and the reservoir module to cause battery contact actuators on the reservoir module to close the power-on contact comprises depressing a receptacle on the electrical module with a protruding region of the battery contact actuator of the reservoir module.

15. The method of claim 1, wherein combining the electrical module and the reservoir module to cause battery contact actuators on the reservoir module to close the power-on contact comprises depressing a deformable member of a receptacle on the electrical module with a protruding region of the battery contact actuator of the reservoir module.

16. The method of claim 1, further comprising executing a power-on check using a controller within the electrical module when the power source is connected to the circuitry.

17. The method of claim 1, further comprising incrementing a logic flag when the electrical module is combined with the reservoir module, wherein the drug delivery device is configured such that, if the logic flag has met or exceeded a predetermined value, the device will either not power on or will power off if it has already powered on.

18. The method of claim 1, further comprising recording an error code if the logic flag has met or exceeded the predetermined value.

19. The method of claim 1, further comprising removing the power source from the circuitry if the electrical module and the reservoir module are separated after they have been combined.

20. The method of claim 1, wherein separately storing the electrical module and the reservoir module, comprises storing the electrical module so that circuitry in the electrical module is electrically isolated from the power source in the electrical module by two power-on contacts between the circuitry and the power source that are separated from each other by at least 0.5 cm.

21. The method of claim 1, further comprising delivering fentanyl or analogs of fentanyl to a user wearing the device.

22. A method of storing an electrotransport drug delivery device to resist corrosion prior to use, the method comprising: separately storing an electrical module and a reservoir module, so that circuitry in the electrical module is electrically isolated from a power source in the electrical module by at least two power-on contacts between the circuitry and the power source when the electrical module is separated from the reservoir module, wherein the power source is isolated from the circuitry by the power-on contacts while any of the power-on contacts are open; combining the electrical module and the reservoir module to form a unitary drug delivery device by connecting the circuitry via an electrical output to an input connector on the reservoir module, wherein combining the electrical module and the reservoir module causes battery contact actuators on the reservoir module to close the power-on contacts allowing the power source to power the circuitry; and electrically connecting the circuitry in the electrical module to at least a pair of active electrodes in the reservoir module when the electrical module is combined with the reservoir module.

23. A method of storing an electrotransport drug delivery device to resist corrosion prior to use, the method comprising: separately storing an electrical module and a reservoir module, so that circuitry in the electrical module is electrically isolated from a power source in the electrical module when the electrical module is separated from the reservoir module; combining the electrical module and the reservoir module to form a unitary drug delivery device by connecting the circuitry via an electrical output to an input connector on the reservoir module, wherein combining the electrical module and the reservoir module causes the power source to power the circuitry; electrically connecting the circuitry in the electrical module to at least a pair of active electrodes in the reservoir module when the electrical module is combined with the reservoir module; incrementing a power-on counter when the circuitry is powered on; and powering off or preventing the device from powering on if the number of counts in the power-on counter exceeds a predetermined value.
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