IP Library Granted Patent US 12,161,620
Granted Patent B2
US 12,161,620 · App. 17/319,365 · Granted Dec 10, 2024

Devices and methods for facilitating and controlling use of a medication

Inventor: Clark Allphin (Seattle, WA)
Assignee: Jazz Pharmaceuticals, Inc.
A61K31/365A61J3/00A61J7/0076A61K31/19A61K31/191A61K31/22A61K31/485A61J3/002
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Quick Facts
Patent No.
US 12,161,620
App. No.
17/319,365
Granted
Dec 10, 2024
Kind
B2
Abstract

A device includes a reservoir configured to store a drug formulation including at least one abuse-preventing additive. The device further includes means configured to remove the at least one abuse-preventing additive. The device further includes means configured to prevent access to the drug formulation.

Claims (64)

1. A device, comprising:

a compartment configured to hold an undiluted form of a substance;

a diluent reservoir configured to hold a diluent;

a dilution chamber configured to hold a diluted form of the substance;

a valve coupled with the compartment and configured to control dispensing of the undiluted form of the substance to an outlet port;

a communication interface operable by a user of the device; and

a controller operably coupled to the valve, wherein the controller is configured to;

control dispensing a dose amount of the substance;

receive a dosing schedule, the dosing schedule including an indication of the dose amount of the substance and a set of dosing times;

communicate, at a first dosing time of the set of dosing times, an indication to the user of availability of the substance;

receive, via the communication interface, a first request from the user to dispense the substance;

operate the valve for dispensing the dose amount of the substance at the first dosing time;

communicate, to the user via the communication interface, an indication of a lockout period during which dispensing of the substance is prohibited;

communicate, at a second dosing time of the set of dosing times, the indication to the user of availability of the substance and of expiration of the lockout period;

receive, via the communication interface, a second request from the user to dispense the substance; and

operate the valve for dispensing the dose amount of the substance at the second dosing time.

2. The device of claim 1 , wherein the substance comprises gamma hydroxybutyrate (GHB).

3. The device of claim 1 , wherein the first-compartment is removably attached to a chamber configured to receive the compartment.

4. The device of claim 1 , wherein the dilution reservoir is removably attached to the device.

5. The device of claim 1 , wherein the controller is configured to automate dispensing of the dose amount.

6. The device of claim 1 , wherein the dosing schedule is a first dosing schedule and the dose amount is a first dose amount, the controller further configured to:

receive the first dosing schedule, the first dosing schedule including an indication of the first dose amount of the substance and the first dosing time;

communicate, at the first dosing time, the indication to the user of availability of the substance;

receive, via the communication interface, the first request from the user to dispense the substance;

operate the valve for dispensing the first dose amount of the substance at the first dosing time;

communicate, to the user via the communication interface, an indication of the lockout period during which dispensing of the substance is prohibited;

receive a second dosing schedule, the second dosing schedule including an indication of a second dose amount of the substance and the second dosing time, the second dose amount different from the first dose amount;

communicate, at the second dosing time, the indication to the user of availability of the substance and of expiration of the lockout period;

receive, via the communication interface, the second request from the user to dispense the substance; and

operate the valve for dispensing the second dose amount of the substance at the second dosing time.

7. The device of claim 1 , the controller further configured to:

receive, via the communication interface, an indication to dispense multiple dose amounts of the substance at a third dosing time;

operate the valve for dispensing the multiple dose amounts of the substance at the third dosing time; and

communicate, to the user via the communication interface, an indication of an extended lockout period during which dispensing of the substance is prohibited, the extended lockout period based on a sum of multiple lockout durations, each lockout duration associated with a dose amount of the multiple dose amounts.

8. The device of claim 1 , further comprising a metering pump configured to deliver the undiluted form of the substance from the compartment to the dilution chamber.

9. The device of claim 1 , further comprising a switching valve configured to control delivery of the diluent from diluent reservoir to the diluent chamber.

10. The device of claim 9 , wherein the switching valve is configured to control gravity-driven delivery of the diluent from the diluent reservoir to the diluent chamber.

11. The device of claim 1 , wherein the controller is further configured to:

generate compliance information association with dispensing of the substance at the first dosing time, at the second dosing time, or both; and

transmit an indication of the compliance information.

12. The device of claim 1 , further comprising a memory, the controller further configured to:

generate compliance information associated with dispensing of the substance at the first dosing time, at the second dosing time, or both; and

store an indication of the compliance information to the memory.

13. The device of claim 1 , wherein the communication interface comprises a light emitter, the controller further configured to communicate, to the user via the light emitter, an indication of the lockout period.

14. The device of claim 1 , wherein the compartment is disposed within a user-accessible portion of the device.

15. The device of claim 14 , wherein the user-accessible portion comprises a lock.

16. The device of claim 15 , wherein the lock is a keyed lock, a combination lock, an electronic lock, or a card key lock.

17. The device of claim 15 , wherein the lock is configured to control unlocking of the user-accessible portion using biometric information.

18. The device of claim 17 , wherein the biometric information comprises fingerprint information, a retinal signature, or a voice signature.

19. A device, comprising:

a compartment comprising an undiluted form of gamma hydroxybutyrate (GHB);

a diluent reservoir comprising a diluent;

a dilution chamber configured to hold a diluted form of the GHB;

a first valve coupled to the compartment and configured to control the flow of the undiluted GHB to the dilution chamber;

a second valve coupled to the diluent reservoir and configured to control the flow of the diluent to the dilution chamber; and

a controller configured to:

receive a dosing schedule, the dosing schedule including an indication of the dose amount of the diluted form of the GHB and a set of dosing times;

communicate, at a first dosing time of the set of dosing times, an indication to the user of availability of the diluted form of the GHB;

receive, via the communication interface, a first request from a user to dispense the diluted form of the GHB;

dispense the dose amount of the diluted form of the GHB at the first dosing time;

communicate, to the user via a communication interface, an indication of a lockout period during which dispensing of the diluted form of the GHB is prohibited;

communicate, at a second dosing time of the set of dosing times, an indication to the user of availability of the diluted form of the GHB and of expiration of the lockout period;

receive, via the communication interface, a second request from the user to dispense the diluted form of the GHB; and

dispense the dose amount of the diluted form of the GHB at the second dosing time.

Assignments (2)
SECURITY AGREEMENT Recorded Jul 26, 2024
From: CAVION, INC.; CELATOR PHARMACEUTICALS, INC.; GW PHARMA LIMITED; JAZZ PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS RESEARCH UK LIMITED (F/K/A GW RESEARCH LIMITED)
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 068173/0155 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 27, 2023
From: ALLPHIN, CLARK
To: JAZZ PHARMACEUTICALS, INC.
Reel/Frame 064080/0119 →