Size-efficient drug-delivery device

• US 10,112,005 B2
• Filed: 09/26/2011
• Issued: 10/30/2018
• Est. Priority Date: 09/27/2010
• Status: Active Grant

• Current Assignee: United Therapeutics Corporation
• Original Assignee: SteadyMed Ltd. (United Therapeutics Corporation)
• Inventors: Rotem, Nir, Fradkin, Keren, Goldstein, Jonathan
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Frehe, William
• Application Number:
  US13/825,806
• Publication Number:
  US 20140148761A1
• Time in Patent Office: 2,591 Days
• Field of Search: 6048901, 6048911, 604131, 604140-146
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure

Abstract

A drug-delivery device comprising a drug-reservoir assembly, displacement-generating actuator, and drug administration unit is described, wherein the drug-reservoir assembly comprises at least one flexible wall and a constraining ring, such that the displacement generated by the actuator collapses a flexible wall of the assembly expelling the drug contents of the drug-reservoir towards said drug administration means.

Claims

1. A drug delivery device comprising a substantially cylindrical drug-reservoir assembly, said substantially cylindrical drug-reservoir assembly comprising:

a collapsible semi-flexible drug reservoir chamber, the chamber having an interior defined by a flexible upper wall, a rigid base wall and a joint region between said flexible upper wall and said rigid base wall;

a housing;

a rigid constraining ring, which constraining ring substantially surrounds outer boundaries of the flexible upper wall, the rigid base wall or a combination thereof of said collapsible semi-flexible drug reservoir chamber, and wherein;

the constraining ring is disposed within the housing,

the constraining ring is separate from the housing, and

the constraining ring is separate from the rigid base wall;

a drug administration unit in fluid communication with said semi-flexible drug reservoir chamber; and

a displacement-generating actuator, located proximally to said semi-flexible drug reservoir chamber, wherein the displacement-generating actuator moves perpendicular to a patient skin surface upon which the drug delivery device is placed;

whereby displacement generated by said displacement-generating actuator operationally connected to said semi-flexible drug reservoir chamber, causes said flexible upper wall to collapse, promotes folding or rolling of said flexible upper wall between the displacement actuating generator and the constraining ring as said flexible upper wall collapses against the rigid base wall of said semi-flexible drug reservoir chamber within the constraints of said rigid constraining ring surrounding a circumference of said flexible upper wall, which further causes substantially expelling drug contents of said semi-flexible drug reservoir chamber toward said drug administration unit thereby delivering said drug contents from said drug delivery device.

2. The drug delivery device of claim 1, wherein said joint region is substantially flexible.

3. The drug delivery device of claim 1 where the upper wall comprises an interior-facing layer comprising a plastic selected from the group consisting of COP (cyclic olefin polymer) and COC (cyclic olefin copolymer), the base wall comprises an interior-facing layer comprising a plastic selected from the group consisting of COP (cyclic olefin polymer) and COC (cyclic olefin copolymer), and the joint region comprises an interior-facing layer comprising a plastic selected from the group consisting of COP (cyclic olefin polymer) and COC (cyclic olefin copolymer), for long-term storage of drugs.

4. The drug delivery device of claim 1 where said displacement-generating actuator comprises a member selected from the group consisting of a spring, a hydrogel or an expanding material selected from the group consisting of a compressed sponge, a gas-generating assembly, a clockwork mechanism and a displacement-generating battery.

5. The drug delivery device of claim 4 wherein said displacement-generating actuator comprises said displacement-generating battery, and where said battery comprises electrodes and electrolyte such that the discharge or charge of said battery causes the total volume of said electrode and electrolyte to expand, thereby generating said displacement.

6. The drug delivery device of claim 4 wherein said displacement-generating actuator comprises said displacement-generating battery, and where said displacement-generating battery generates gas internally as said battery is discharged or charged, causing the battery to expand and generate said displacement.

7. The drug delivery device of claim 1,

wherein said semi-flexible drug reservoir chamber has a volume capacity of from about 1 to about 20 ml,

wherein said semi-flexible drug reservoir chamber has a volume capacity of from about 3 to about 10 ml,

wherein said semi-flexible drug reservoir chamber has a diameter of from about 20 to about 70 mm, or

wherein said semi-flexible drug reservoir chamber has a height of from about 1 mm to about 5 mm.

8. The drug delivery device of claim 1, wherein said semi-flexible drug reservoir chamber comprises a multi-layer plastic film.

9. The drug delivery device of claim 8, wherein said multi-layer plastic film comprises additional layers which serve as a water vapor barrier, an oxygen barrier or a combination thereof, and wherein said multi-layer plastic film has further additional separation or tie-layers.

10. The drug delivery device of claim 1, wherein said semi-flexible drug reservoir chamber contains a drug therein.

11. The drug delivery device of claim 1, wherein said drug administration unit comprises a micro-needle, a micro-needle array, a rigid cannula or a soft cannula.

12. The drug delivery device of claim 1, further comprising one or more collapsible semi-flexible drug reservoir chambers.

13. A method of drug delivery to a subject comprising contacting a subject with the drug delivery device of claim 1.

14. The drug delivery device of claim 1, wherein said joint region is substantially flexible, and wherein said displacement generated by said displacement-generating actuator causes said substantially flexible joint region to collapse and promotes folding or rolling of said substantially flexible joint region as the substantially flexible joint region collapses.

15. The drug delivery device of claim 1, wherein a piston of the displacement-generating actuator moves relative to the constraining ring and the housing as a result of the displacement generated by the displacement-generating actuator.

16. The drug delivery device of claim 1, wherein the constraining ring limits sideways movement of the joint region while said drug contents are delivered from said drug delivery device.

17. The drug delivery device of claim 1, wherein the joint region folds against itself to form a concentric area as a result of the displacement generated by the displacement-generating actuator.

18. The drug delivery device of claim 1, wherein a piston of the displacement-generating actuator slides concentrically within the constraining ring as a result of the displacement generated by the displacement-generating actuator.

19. The drug delivery device of claim 1, wherein the constraining ring remains stationary relative to the housing while said drug contents are delivered from said drug delivery device.

20. The drug delivery device of claim 1, wherein the joint region folds against itself between the constraining ring and a piston of the displacement-generating actuator as a result of the displacement generated by the displacement-generating actuator.

21. The drug delivery device of claim 1, wherein the constraining ring and a piston of the displacement-generating actuator are disposed to provide a space therebetween that promotes folding of the joint region against itself as a result of the displacement generated by the displacement-generating actuator.

22. The drug delivery device of claim 1, wherein said displacement generated by said displacement-generating actuator promotes folding or rolling of said flexible upper wall between the rigid constraining ring and said displacement-generating actuator as the displacement-generating actuator moves perpendicular to the patient skin surface upon which the drug delivery device is placed.

23. The drug delivery device of claim 1, wherein said flexible upper wall and said rigid base wall of said collapsible semi-flexible drug reservoir chamber are welded together.

24. The drug delivery device of claim 23, wherein said flexible upper wall and said rigid base wall of said collapsible semi-flexible drug reservoir chamber are welded together via a circular welding contour line.

25. The drug delivery device of claim 1, wherein said displacement-generating actuator comprises an outer piston wall, wherein said constraining ring is disposed between said housing and said outer piston wall, and wherein said constraining ring is parallel with said outer piston wall.

26. The drug delivery device of claim 1, wherein said constraining ring is perpendicular to said rigid base wall at a point on said rigid base wall where said constraining ring contacts said rigid base wall.