Drug delivery device

• US 7,384,413 B2
• Filed: 06/13/2003
• Issued: 06/10/2008
• Est. Priority Date: 03/23/1998
• Status: Expired due to Term

• Current Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Lavi, Gilad, Carmel, Ehoud, Gross, Joseph, Yigal, Gil, Tsals, Izrail
• Primary Examiner(s): Lucchesi; Nicholas D.
• Assistant Examiner(s): Stigell; Theodore J
• Application Number:
  US10/461,040
• Publication Number:
  US 20030236498A1
• Time in Patent Office: 1,824 Days
• Field of Search: 604140-141, 604145-147, 604/890.1, 604/131, 604/181, 604/151, 604/143, 604/153, 604/93.01, 128/DIG.12
• US Class Current: 604/141
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 33/22 Boron compounds
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/14533 cam actuated
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/155 pressurised by gas introduced into the reservoir
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31571 Means preventing accidental administration for automatic syringes A61M5/20
• CPC Class Codes: A61M 5/31586 performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle
• CPC Class Codes: Y10S 128/12 Pressure infusion
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A drug delivery device having a housing containing a gas generator controlled by an electronic controller. The gas generator generates gas into a reciprocable chamber, whereby reciprocation of the chamber causes a lever to reciprocate a pawl, and this action causes a ratchet to The device may also be provided with manually control for delivering a bolus dose of drug when necessary.

Claims

1. A drug delivery device comprising:

a housing containing a drug reservoir;

a slidable piston operable to expel drug from the drug reservoir;

a mechanism in communication with the piston the mechanism being operable to undergo incremental advancement and thereby to drive the drug from the reservoir in a series of fixed increments;

a member operatively associated with the mechanism to cause the incremental advancement of the mechanism as the member moves in a first direction; and

a gas generator located within the housing and operable to generate gas to expand in a chamber, the member being in transmission relation to the chamber, whereby the member is driven by the movement of the chamber to advance the mechanism and thereby drive the drug from the reservoir in the series of fixed increments, each of the fixed increments corresponding to a respective advancement of the mechanism.

2. The drug delivery device according to claim 1 wherein the member moves in a reciprocable fashion.

3. The drug delivery device according to claim 2, wherein the reciprocable movement of the member causes the stepwise advancement of the mechanism.

4. The drug delivery device according claim 2, wherein the member is connected to a wall of the chamber, whereby the reciprocable movement of the member is driven by the expansion and contraction of the chamber.

5. The drug delivery device according to claim 1, wherein the chamber is elastically biased to revert to a contracted state, and wherein a venting member is provided to enable contraction of the chamber after gas generation has expanded the chamber.

6. The drug delivery device according to claim 5, wherein the venting member is passive and allows escape of gas therethrough when the chamber is pressurized relative to atmospheric pressure.

7. The drug delivery device according to claim 6, wherein the gas generator is adapted to generate gas at a rate higher than the rate at which venting occurs, whereby when the gas generator is active, the chamber becomes pressurized and expands, and when the gas generator is inactive, the venting means member causes depressurization and contraction of the chamber.

8. The drug delivery device according to claim 6, wherein the venting member comprises a permeable or semi-permeable member.

9. The drug delivery device according to claim 8, wherein the venting member is a silicone membrane.

10. The drug delivery device according to claim 1, wherein the member comprises a lever extending between the chamber and the mechanism.

11. The drug delivery device according to claim 1, wherein the mechanism comprises a rigid ratchet element having spaced formations on a surface thereof.

12. The drug delivery device according to claim 11, wherein the formations have a sawtooth cross section.

13. The drug delivery device according claim 11, wherein the formations are grooves on a surface of the rigid ratchet element.

14. The drug delivery device according to claim 11, further comprising a pawl carried on the member, the pawl being adapted to make ratcheting engagement with the formations on the rigid ratchet element.

15. The drug delivery device according to claim 14, wherein the pawl is resiliently biased against the formations on the rigid ratchet element.

16. The drug delivery device according to claim 15, wherein the pawl is in the form of a substantially flat spring an end of which bears against the formations on the rigid ratchet element.

17. The drug delivery device according to claim 15, wherein the formations are regularly spaced along the rigid ratchet element, and wherein the pawl comprises a pair of pawl members resiliently biased against the rigid ratchet element at different points along the length of the rigid ratchet element, the axial distance between the pair of pawl members being different to the axial distance between successive formations.

18. The drug delivery device according to claim 17, wherein the distance between successive formations is twice the distance between the pawl members.

19. The drug delivery device according to claim 17, wherein the pawl is in the form of a resilient member which terminates in the pawl members which are in the form of a plurality of fingers biased against the ratchet element.

20. The drug delivery device according to claim 1, further comprising electronic control means for controlling the delivery rate.

21. The drug delivery device according to claim 20, wherein the electronic control means comprises a timing mechanism which alternately energizes and de-energizes the gas generator for controlled periods.

22. The drug delivery device according to claim 20, wherein the electronic control means is programmable for different delivery programs.

23. A method of delivering drug to a patient comprising the steps of:

affixing a drug delivery device to the surface of the patient'"'"'s skin, the drug delivery device comprising;

a housing containing a drug reservoir;

a piston slidably supported in the housing and operable to expel drug from the drug reservoir;

a mechanism in communication with the piston, the mechanism being operable to in cycles to drive the drug from the reservoir in a series of fixed increments;

a member operatively associated with the mechanism to start the cyclical operation of the mechanism as the member moves in a first direction; and

a gas generator located within the housing and operable to generate gas to expand a chamber, the member being in transmission relation to the chamber; and

activating the device whereby the member is driven by the movement of the chamber to cycle the mechanism and thereby drive the drug from the reservoir in the series of fixed increments, each of the fixed increments corresponding to a respective cycle of the mechanism.

24. The method according to claim 23, wherein the mechanism in communication with the facilitation means comprises a ratchet.

25. The method according to claim 24, wherein the reciprocable movement of the reciprocable member causes the cyclical operation of the mechanism.

26. The method according to claim 23, wherein the member moves in a reciprocable fashion.

27. The method according to claim 26, wherein the member is connected to a wall of the chamber, whereby the reciprocable movement of the member is driven by the expansion and contraction of the chamber.

28. A drug delivery device comprising:

a housing containing a drug reservoir in fluid communication with a needle;

a piston slidably supported within the housing and operable to expel drug from the drug reservoir and through the needle;

a mechanism in communication with the piston, the mechanism being operable in cycles to drive the drug from the reservoir in a series of increments;

a gas generator located within the housing and operable to generate gas to expand a chamber;

a vent configured to allow escape of gas from the chamber to enable contraction of the chamber after gas generation has expanded the chamber;

a member operatively associated with the mechanism and in transmission relation to the chamber, the member being pivotably supported and driven in a first direction during expansion of the chamber, and in a second direction opposite the first direction during contraction of the chamber, such movement of the member causing a cycle of operation of the mechanism, successive cycles of the mechanism driving the drug through the needle in the series of increments, each of the increments corresponding to a respective cycle of the mechanism.