Drug delivery technology

• US 8,574,188 B2
• Filed: 08/25/2011
• Issued: 11/05/2013
• Est. Priority Date: 09/11/2001
• Status: Expired due to Term

• Current Assignee: Enesi Pharma Limited
• Original Assignee: Glide Pharmaceutical Technologies Limited
• Inventors: Potter, David Stuart, Potter, Charles David Ogilvy
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): STOHR, LEAH C
• Application Number:
  US13/217,672
• Publication Number:
  US 20110313348A1
• Time in Patent Office: 803 Days
• Field of Search: 604/59, 604 68- 72, 604/117, 604/93.01, 604130-135, 604/181, 604/187, 604/218, 604/225, 604/227, 604/232, 604/234, 604/235, 604/115
• US Class Current: 604/59
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 2005/005 Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/3015 for injecting a dose of particles in form of powdered drug, e.g. mounted on a rupturable membrane and accelerated by a gaseous shock wave or supersonic gas flow cell injection devices C12M3/006
• CPC Class Codes: F42B 12/54 by implantation, e.g. hypodermic projectiles

Abstract

The invention relates to a novel drug delivery technology. More particularly the invention relates to a method of delivering at least one therapeutic compound or a formulation comprising the at least one therapeutic compound to a patient; to a throwaway or reusable device for delivering at least one therapeutic compound or a formulation comprising the at least one therapeutic compound to a patient in a manner as set out by the method; to a pioneer projectile for use in said method; to formulations for use in said method and to an injectate comprising a pioneer projectile and formulation. It also relates to a disposable component containing either a pioneer projectile or an injectate. The invention also relates to a throwaway or reusable device for delivering at least one therapeutic compound, or a formulation comprising the at least one therapeutic compound (hereafter drug) to a patient, and a method for administering a drug to a patient using said device. It also relates to a packaged drug for use with said device.

Claims

1. A drug delivery device comprising a housing, said housing comprising:

i) an upper barrel at one end of the device which houses a generator of a force capable of pushing a drug from a packaging into a human or animal body; and

ii) a lower barrel, at the end remote from the upper barrel, which houses;

a) a packaged drug assembly;

b) a striker to cause the drug to be pushed from the packaged drug assembly;

c) a receiver for receiving the packaged drug assembly;

d) a trigger device; and

said lower barrel being in operative communication with said upper barrel;

and wherein the packaged drug assembly and striker are slidably mounted in the device, and pushing the device against the skin with sufficient force causes the packaged drug assembly and striker to slide up the lower barrel and the device to be primed and actuated.

2. A drug delivery device as claimed in claim 1 wherein the generator is capable of generating a force of from 10-40N.

3. A drug delivery device as claimed in claim 1 wherein the transmitter causes the drug to be pushed from the packaging at less than 10m/s.

4. A drug delivery device as claimed in claim 1 wherein said packaged drug assembly is slidably disposed in the receiver.

5. A drug delivery device as claimed in claim 1 wherein the packaged drug assembly is slidably disposed in the lower barrel and comprises a a packaged drug assembly housing having a channel running there through in which is disposed a drive pin, a skin piercing element and the drug;

said packaged drug assembly housing further comprising

a region allowing the packaged drug assembly to be slidably mounted to the drug delivery device at the receiver.

6. A drug delivery device as claimed in claim 5 wherein the skin piercing element is a pioneer projectile, a syringe needle or the head of a drug splinter.

7. A drug delivery device as claimed in claim 5 wherein the drive pin or other element has a flat or enlarged head.

8. A drug delivery device as claimed in claim 5 further comprising a resilient element below or otherwise in association with the drive pin or other element to ensure the drive pin is withdrawn after use.

9. A drug delivery device as claimed in claim 5 wherein the packaged drug assembly further comprises an end adapted to engage and tension the skin.

10. A drug delivery device as claimed in claim 1 wherein the generator is a spring.

11. A drug delivery device as claimed in claim 10 wherein the spring is a coil or gas spring.

12. A drug delivery device as claimed in claim 10 wherein the force generated by the spring is adjustable.

13. A drug delivery device as claimed in claim 10 further comprising a sliding piston, wherein the packaged drug assembly acts against the sliding piston and causes the spring to be tensioned and the device primed.

14. A drug delivery device as claimed in claim 1 wherein the trigger device comprises a region of the striker that is shaped to fit a correspondingly shaped surface in a wall separating the upper and lower barrels defined by the housing and wherein the striker is aligned to strike a drive pin in the packaged drug assembly on actuation.

15. A drug delivery device as claimed in claim 14 wherein the device comprises a slewing spring, a sliding piston having an aperture therein, all housed in the lower barrel and the device is triggered by the sliding of the piston up the lower barrel until the shoulder region of the striker engages the shaped surface and aligns the striker with the aperture in the sliding piston such that the striker moves down the aperture under the action of the generator.

16. A device as claimed in claim 15 wherein the action of pushing the packaged drug assembly up the lower barrel with sufficient force causes the sliding piston to move up the lower barrel thereby causing the striker to be pushed up the lower barrel out of a first position in which it is not axially aligned with the aperture in the sliding piston which operatively communicates with the packaged drug assembly and at the same time acts on a spring follower in the upper barrel causing the spring to be compressed and the device primed such that when the required delivery force is generated the striker is axially aligned with the aperture of the sliding piston and is thus actuated such that the spring acts through the spring follower and striker upon the drive pin in the packaged drug assembly to deliver the drug into the human or animal body.

17. A drug delivery device as claimed in claim 1 wherein the striker comprises a substantially frustoconical shoulder region which engages a substantially frustoconical surface in the wall separating the upper and lower barrels defined by the housing.

18. A drug delivery device as claimed in claim 1 wherein the device is primed and actuated by a single action.

19. A device as claimed in claim 1 wherein the device is primed and actuated by two separate actions.

20. A drug delivery device as claimed in claim 1 wherein the upper barrel and lower barrel are formed as separate components.

21. A drug delivery device as claimed in claim 1 wherein the drug is in a contained form.

22. A drug delivery device as claimed in claim 21 wherein the drug is either:

a liquid contained by a membrane;

a liquid with a viscosity of at least 500 centipoises, a semi solid, a paste, a gel or a solid.

23. A drug delivery device as claimed in claim 1 wherein the packaged drug assembly is an integral part of the device.

24. A drug delivery device as claimed in claim 1 in which the device and/or packaged drug assembly is sealed in a foil pouch or the like to prevent ingress at:

for example, moisture, oxygen, light, bacteria or other drug degrading or contaminating agents.

25. A drug delivery device as claimed in claim 1 further comprising a positive lock retention system to ensure the packaged drug assembly does not come away from the device under gravity yet is free to slide up the device.

26. A single use drug delivery device as claimed in claim 1 wherein the

packaged drug assembly forms an integral part of the device.

27. A drug delivery device as claimed in claim 1 wherein the packaged drug assembly is disposable.

28. A drug delivery device as claimed in claim 1 wherein the striker is in a non-axially aligned position prior to device actuation.

29. A drug delivery device as claimed in claim 1 wherein prior to actuation the striker is held in a first non-axially aligned position and the sliding of the packaged drug assembly up the lower barrel causes the striker to move into a second, axially aligned position to actuate the device.

30. A drug delivery device as claimed in claim 1 further comprising a slewing spring that holds the striker in a non-axially aligned position prior to actuation and returns the striker to the non-axially aligned position after actuation.

31. A packaged drug assembly, for use with the drug delivery device of claim 1, comprising a packaged drug assembly housing having a channel running there through and in which is disposed a drive pin, a skin piercing element, and a drug, said packaged drug assembly housing further comprising

i) a region allowing the packaged drug assembly to be slidably mounted to the drug delivery device;

and

ii) an end adapted to engage and tension the skin.