Drug delivery methods and systems

• US 10,232,156 B2
• Filed: 09/08/2017
• Issued: 03/19/2019
• 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): Price, Nathan R
• Assistant Examiner(s): Ulsh, Dung
• Application Number:
  US15/699,382
• Publication Number:
  US 20180117291A1
• Time in Patent Office: 557 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 two-part bioactive agent delivery system, the two-part bioactive agent delivery system comprising:

a disposable part comprising

an agent reservoir, the agent reservoir comprising a piston movably disposed in a chamber,

a bolus chamber, the bolus chamber comprising a piston movably disposed in a chamber, the volume of the bolus chamber being less than the volume of the agent reservoir,

an agent outlet communicating with the bolus chamber to receive a bioactive agent dissolved in a solvent from the bolus chamber, 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 agent outlet; and

a reusable part comprising 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 the bioactive agent from the agent reservoir to the agent outlet;

a first spring extending between the agent reservoir piston and a surface to pressurize the agent reservoir when the first spring is compressed and the agent reservoir contains a quantity of the bioactive agent; and

a second spring extending between the bolus chamber piston and a surface, the second spring being at least partially loaded when a quantity of the bioactive agent is present in the bolus chamber.

2. The two-part bioactive agent delivery system of claim 1 further comprising a transdermal patch communicating with the outlet and adapted to transdermally deliver the bioactive agent to a user.

3. The two-part bioactive agent delivery system of claim 2 further comprising a solvent recovery chamber disposed in the disposable part and communicating with the transdermal patch, the solvent recovery chamber being adapted to receive gaseous phase solvent from the transdermal patch, and a desiccant or absorbent material disposed in the solvent recovery chamber.

4. The two-part bioactive agent delivery system of claim 3 further comprising a vapor permeable membrane in the disposable part adjacent to the transdermal patch and in fluid communication with the solvent recovery chamber.

5. The two-part bioactive agent delivery system of claim 4 wherein the agent outlet is configured to provide the bioactive agent dissolved in the solvent to a space between the transdermal patch and the vapor permeable membrane.

6. The two-part bioactive agent delivery system of claim 2 wherein the transdermal patch comprises a polypropylene membrane.

7. The two-part bioactive agent delivery system of claim 6 wherein the polypropylene membrane has pores with an average pore diameter of about 0.02 μ

m to about 0.10 μ

m.

8. The two-part bioactive agent delivery system of claim 1 wherein the first spring wherein the spring is disposed in the disposable part prior to connecting the disposable part to the reusable part.

9. The two-part bioactive agent delivery system of claim 1 wherein the first spring wherein the spring is disposed in the reusable part prior to connecting the disposable part to the reusable part.

10. The two-part bioactive agent delivery system of claim 1 wherein the second spring extends between the bolus chamber piston and a surface in the disposable part, the bolus chamber piston being adapted to move and load the second spring when pressurized bioactive agent enters the bolus chamber from the agent reservoir through the valve.

11. The two-part bioactive agent delivery system of claim 1 wherein the second spring extends between the bolus chamber piston and a surface in the reusable part.

12. The two-part bioactive agent delivery system of claim 1 wherein the valve is a rotatable valve having a range of motion between 60°

to 90°

, inclusive.

13. The two-part bioactive agent delivery system of claim 1 wherein the surface comprises a surface in the reusable part, the first spring becoming at least partially loaded when the disposable part is connected to the reusable part and the agent reservoir contains a quantity of the bioactive agent.

14. The two-part bioactive agent delivery system of claim 1 wherein the agent reservoir and bolus chamber are configured to contain a bioactive agent and a solvent solution comprising alcohol and water, wherein the solvent solution has a ratio of water to alcohol of about 40:

60 to about 60;

40.

15. The two-part bioactive agent delivery system of claim 1 further comprising a connection indicator operatively connected to the control electronics to provide an indication that the reusable part has been connected to the disposable part.