Drug reconstitution and delivery device and methods

• US 9,999,720 B2
• Filed: 09/27/2012
• Issued: 06/19/2018
• Est. Priority Date: 09/27/2012
• Status: Active Grant

• Current Assignee: Xerox Corporation (Xerox Holdings Corp.)
• Original Assignee: Palo Alto Research Center, Inc. (Xerox Holdings Corp.)
• Inventors: Uhland, Scott A., Linn, Felicia, Recht, Michael I.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US13/629,184
• Publication Number:
  US 20140088486A1
• Time in Patent Office: 2,091 Days
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing

Abstract

Devices and methods are provided for drug delivery. The device may include a housing having a first compartment containing a drug in a dry, solid form, a second compartment containing a liquid carrier for the drug, and an expansion member located within or adjacent to the first or second compartment. The second compartment may be fluidly connectable to the first compartment by a rupturable barrier or mechanical valve. The device may also include an actuation system configured to expand the expansion member to rupture the rupturable barrier or open the mechanical valve and permit the liquid carrier to flow into the first compartment and mix with the drug to form a reconstituted drug solution.

Claims

1. A drug delivery device comprising:

a housing configuration for implantation in a human or animal subject which comprises;

a first compartment containing a drug in a dry, solid form;

a second compartment containing a liquid carrier for the drug, the second compartment being fluidly connectable to the first compartment by a rupturable barrier or mechanical valve; and

an expansion member located within or adjacent to the first or second compartment, wherein the expansion member is a balloon structure comprising a flexible, elastomeric sheet; and

an actuation system configured to expand the expansion member to rupture the rupturable barrier or open the mechanical valve and to expand and contract the expansion member to produce a mixing action to permit the liquid carrier to flow into the first compartment and mix with the drug to form a reconstituted drug solution.

2. The device of claim 1, wherein the device is configured such that continued expansion of the expansion member causes the reconstituted drug solution to be expelled from the device via a release outlet in at least one of the first and second compartments.

3. The device of claim 1, wherein the actuation system is configured to generate a displacement fluid that expands the expansion member.

4. The device of claim 1, wherein the actuation system comprises an electrochemical pump.

5. The device of claim 1, wherein the rupturable barrier comprises a friable or dissolvable seal.

6. The device of claim 1, wherein the device is configured for intravaginal retention in the human or animal subject.

7. The device of claim 1, further comprising at least one additional housing.

8. The device of claim 1, wherein the expansion member comprises a protrusion member effective to open the mechanical valve upon expansion of the expansion member.

9. The device of claim 1, wherein the expansion member comprises a spike member effective to puncture the rupturable barrier upon expansion of the expansion member.

10. The device of claim 1, wherein the drug comprises a lyophilized drug formulation.

11. The device of claim 1, wherein an interior surface of the first and/or second compartments comprises a hydrophobic or hydrophilic coating.

12. The device of claim 1, wherein the liquid carrier comprises water and one or more pharmaceutically acceptable excipients.

13. A method of delivering a drug comprising:

deploying a drug delivery device into a human or animal subject, wherein the drug delivery device comprises a first compartment containing a drug in a dry, solid form and a second compartment containing a liquid carrier for the drug;

inflating an expandable membrane to rupture a rupturable barrier or open a mechanical valve to fluidly connect the first and second compartments;

mixing the liquid carrier with the drug to form a reconstituted drug solution, wherein the step of mixing the liquid carrier with the drug comprises expanding and contracting the expandable membrane; and

releasing the reconstituted drug solution from the first and/or second compartment.

14. The method of claim 13, wherein the drug comprises a lyophilized drug formulation.

15. The method of claim 13, wherein the step of releasing the reconstituted drug solution comprises inflating the expandable membrane to displace the reconstituted drug solution from the first and/or second compartments through at least one release outlet in at least one in the first and/or second compartments.

16. The method of claim 13, wherein the expansion member comprises a protrusion member effective to open the mechanical valve upon expansion of the expansion member.

17. The method of claim 13, wherein the expansion member comprises a spike member effective to puncture the rupturable barrier upon expansion of the expansion member.

18. The method of claim 13, wherein the drug delivery device is deployed into the human or animal subject intravaginally.

19. A drug delivery device comprising:

a first compartment containing a drug in a dry, solid form;

a second compartment containing a liquid carrier for the drug, the second compartment being fluidly connectable to the first compartment by a rupturable barrier;

an expansion member; and

an actuation system configured to expand and contract the expansion member to mix the liquid carrier with the drug, after the rupturable barrier is ruptured, to form a reconstituted drug solution and expel the reconstituted drug solution from the device via a release outlet.

20. The device of claim 19, wherein the rupturable barrier comprises a material configured to degrade upon being heated to a specified temperature and/or exposed to light irradiation of a specified wavelength.

21. The device of claim 19, wherein the rupturable barrier comprises a material soluble in the liquid carrier.

22. A method of administering a drug to a human or animal subject, the method comprising:

providing a drug delivery device which comprises;

a first compartment containing a drug in a dry, solid form,

a second compartment containing a liquid carrier for the drug, and

an expansion member;

rupturing a rupturable barrier to place the first and second compartments in fluid communication with one another;

deploying the drug delivery device in the human or animal subject; and

controlling the expansion member to (i) expand and contract to facilitate mixing of the liquid carrier with the drug to form a reconstituted drug solution, and (ii) release the reconstituted drug solution from a release outlet of the device.

23. The method of claim 22, wherein the rupturing of the rupturable barrier is performed prior to the deployment of the drug delivery device in the human or animal subject.

24. The method of claim 23, wherein the step of rupturing the rupturable barrier comprises manually shaking the device.

25. The method of claim 24, wherein the drug comprises particles configured to puncture the rupturable barrier upon shaking.

26. The method of claim 22, wherein the rupturing of the rupturable barrier is performed after the deployment of the drug delivery device in the human or animal subject.

27. The method of claim 22, wherein the drug delivery device is deployed intravaginally in the human or animal subject.