Drug delivery methods and systems

• US 10,213,586 B2
• Filed: 01/28/2016
• Issued: 02/26/2019
• Est. Priority Date: 01/28/2015
• Status: Active Grant

• Current Assignee: Morningside Venture Investments Ltd. (Morningside Group Ltd.)
• Original Assignee: Chrono Therapeutics Inc.
• Inventors: Netzel, Zita S., Stacey, Gary, Norman, Alexander David, Huang, Congyi, Frearson, Timothy Charles, Kilby, Charles Frazer, Ruane, Patrick H., Levy, Alan J., Gelston, Kevin W., Darmour, Jennifer, Hapgood, Jenny E., Roth, David Evans, Overbeck, Ronald A., Tong, Ling-Kang
• Primary Examiner(s): Gilbert, Andrew
• Assistant Examiner(s): Ulsh, Dung
• Application Number:
  US15/009,683
• Publication Number:
  US 20160220798A1
• Time in Patent Office: 1,125 Days
• 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 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 35/00 Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• 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 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

A two-part bioactive agent delivery system, the system including a disposable part comprising an agent reservoir, a bolus chamber, the volume of the bolus chamber being less than the volume of the agent reservoir, an agent outlet, and a valve having a first position communicating the agent reservoir with the bolus chamber and a second position communicating the bolus chamber with the outlet; and a reusable part including a valve driver, a power source and control electronics, the control electronics being adapted to control the valve driver to actuate the valve to deliver bioactive agent from the agent reservoir to the agent outlet; the system further having a spring extending between the agent reservoir piston and a surface of the reusable part or of the disposable part to pressurize the agent reservoir when the spring is compressed and the agent reservoir contains a quantity of bioactive agent.

Claims

1. A method for delivering a bioactive agent to a user, the method comprising:

connecting a reusable part of a delivery system to a disposable part of the delivery system;

during the connecting step, compressing a first spring extending from an agent reservoir of the disposable part to pressurize the bioactive agent within the agent reservoir;

actuating a valve driver in the reusable part to move a valve in the disposable part to a first position to transfer the bioactive agent from the agent reservoir to a bolus chamber;

actuating the valve driver to move the valve to a second position to transfer the bioactive agent from the bolus chamber to an agent outlet; and

compressing a second spring extending from the bolus chamber to pressurize the bioactive agent within the bolus chamber.

2. The method of claim 1 wherein the disposable part comprises a transdermal patch communicating with the agent outlet, the method further including transferring the bioactive agent from the bolus chamber to the transdermal patch.

3. The method of claim 2 wherein the disposable part further comprises a solvent recovery chamber, the bioactive agent being dissolved in a solvent in a liquid phase, the method further comprising receiving the solvent in a gaseous phase from the transdermal patch in the solvent recovery chamber.

4. The method of claim 3 wherein the disposable part further comprises a vapor permeable membrane, the receiving step comprising passing the solvent in the gaseous phase through the vapor permeable membrane into the solvent recovery chamber.

5. The method of claim 2 wherein the transdermal patch comprises a polypropylene membrane with a plurality of pores having an average pore diameter of about 0.02 μ

m to about 0.10 μ

m.

6. The method of claim 1 wherein the bioactive agent is dissolved in a solution comprising alcohol and water in a ratio of alcohol to water of about 40:

60 to about 60;

40.

7. The method of claim 1 wherein the delivery system further comprises a piston movably disposed in the bolus chamber, the method further comprising moving the piston with the second spring to move the bioactive agent from the bolus chamber to the agent outlet.

8. The method of claim 1 wherein the second spring is compressed during the connecting step.

9. The method of claim 1 wherein the second spring is compressed when the bioactive agent is transferred from the agent reservoir into the bolus chamber.

10. The method of claim 1 wherein the valve rotates between 60°

to 90°

, inclusive, during the actuating steps.

11. The method of claim 1 further comprising, during or after the connecting step, providing an indication to a remote device that the disposable part has been connected to the reusable part.

12. The method of claim 1 further comprising generating an indication that the disposable part needs to be replaced.

13. The method of claim 12 wherein the generating step comprises monitoring time elapsed after connecting the disposable part to the reusable part and providing the indication that the disposable part needs to be replaced after a predetermined time.

14. The method of claim 1 further comprising receiving an input from the user on the reusable part indicating that the user is experiencing a craving.

15. The method of claim 14 further comprising wirelessly transmitting an indication of the input to a remote device.

16. The method of claim 15 further comprising receiving a wireless signal indicating a psychological support in response to the input from the user indicating the craving.

17. The method of claim 1, wherein the bioactive agent is moved through the valve when transferring from the agent reservoir to the bolus chamber and when transferring from the bolus chamber to the agent outlet.

18. The method of claim 1, wherein the step of actuating a valve driver in the reusable part to move a valve in the disposable part to a first position to transfer the bioactive agent from the agent reservoir to a bolus chamber is performed after the step of connecting a reusable part of a delivery system to a disposable part of the delivery system, and wherein the bioactive agent transferred from the agent reservoir to the bolus chamber is the pressurized bioactive agent.

19. The method of claim 1, wherein the delivery system further comprises a piston movably disposed in the agent reservoir, the method further comprising moving the piston with the spring to move the bioactive agent from the agent reservoir to the bolus chamber.

20. A method for delivering a bioactive agent to a user, the method comprising:

connecting a reusable part of a delivery system to a disposable part of the delivery system;

during the connecting step, compressing a first spring extending from an agent reservoir of the disposable part to pressurize the bioactive agent within the agent reservoir;

actuating a valve driver in the reusable part to move a valve in the disposable part to a first position, wherein moving the valve to the first position allows the spring to force the bioactive agent from the agent reservoir to a bolus chamber;

actuating the valve driver to move the valve to a second position to transfer the bioactive agent from the bolus chamber to an agent outlet; and

compressing a second spring extending from the bolus chamber to pressurize the bioactive agent within the bolus chamber.

21. The method of claim 20 wherein the disposable part comprises a transdermal patch communicating with the agent outlet, the method further including transferring the bioactive agent from the bolus chamber to the transdermal patch.

22. The method of claim 20 wherein the delivery system further comprises a piston movably disposed in the bolus chamber, the method further comprising moving the piston with the second spring to move the bioactive agent from the bolus chamber to the agent outlet.

23. The method of claim 20 wherein the second spring is compressed during the connecting step.

24. The method of claim 20 wherein the second spring is compressed when the bioactive agent is transferred from the agent reservoir into the bolus chamber.

25. The method of claim 20 wherein the valve rotates between 60°

to 90°

, inclusive, during the actuating steps.

26. The method of claim 20 further comprising, during or after the connecting step, providing an indication to a remote device that the disposable part has been connected to the reusable part.

27. The method of claim 20 further comprising generating an indication that the disposable part needs to be replaced.

28. The method of claim 27 wherein the generating step comprises monitoring time elapsed after connecting the disposable part to the reusable part and providing the indication that the disposable part needs to be replaced after a predetermined time.

29. The method of claim 20 further comprising receiving an input from the user on the reusable part indicating that the user is experiencing a craving.

30. The method of claim 29 further comprising receiving a wireless signal indicating a psychological support in response to the input from the user indicating the craving.

31. The method of claim 20, wherein bioactive agent is moved through the valve when transferring from the agent reservoir to the bolus chamber and when transferring from the bolus chamber to the agent outlet.