Cartridge-based drug delivery device

• US 5,858,001 A
• Filed: 12/10/1996
• Issued: 01/12/1999
• Est. Priority Date: 12/11/1995
• Status: Expired due to Term

• Current Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Original Assignee: Elan Medical Technologies Ltd. (Perrigo Company PLC)
• Inventors: Lavi, Gilad, Tsals, Izrail, Gross, Joseph
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/763,311
• Time in Patent Office: 763 Days
• Field of Search: 604/131, 604/132, 604/134, 604/135, 604/140, 604/141, 604/143, 604/145, 604/156, 604/223, 604/233, 604/187, 604/218, 604/51, 604/232, 604/136, 604/137, 604/157
• US Class Current: 604/135
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork

Abstract

A liquid drug delivery device is adapted to be adhered to the skin of a subject by a base member defining a skin-contacting surface having an adhesive coating. A columnar cartridge serves as reservoir for the drug and is incorporated in a housing which is connected to the base member such that in use the longitudinal axis of the cartridge is disposed substantially parallel to the skin-contacting surface. A delivery needle communicating in use with the interior of the cartridge penetrates the skin of the subject when the housing snaps downward relative to the base member. This action also causes the actuation of a citric acid/sodium bicarbonate gas generator which generates a gas to move a piston within the cartridge, compressing the drug compartment. This compression causes a stopper to be penetrated by a conduit in communication with the delivery needle, allowing the drug to be ejected from the compartment through the needle and into the subcutaneous tissue of the subject.

Claims

1. A liquid drug delivery device comprising a base member defining a skin-contacting surface for application to the skin of a subject, a columnar cartridge having a longitudinal axis and an interior serving as reservoir for the drug and which is connected to the base member such that in use the longitudinal axis of the cartridge is disposed substantially parallel to the skin-contacting surface, a delivery needle communicating in use with the interior of the cartridge and adapted to penetrate the skin of the subject, and means for expelling a drug out of the interior of the cartridge and through the skin of the subject via the delivery needle.

2. A device according to claim 1, wherein a portion of the interior of the cartridge defines a drug compartment for the drug, the drug being expelled from the compartment by a piston actuated by the expelling means.

3. A device according to claim 2, wherein the interior of the cartridge also defines a chamber housing the expelling means, such that the actuation of the piston by the expelling means causes the expansion of said chamber and the contraction of said drug compartment.

4. A device according to claim 2, further comprising a conduit establishing fluid communication in use between the drug compartment and the delivery needle.

5. A device according to claim 4, wherein the conduit extends at substantially right angles from the delivery needle.

6. A device according to claim 5, wherein the conduit is integral with the delivery needle.

7. A device according to claim 4, wherein the delivery needle and the conduit form part of a needle assembly mounted on an end of the cartridge.

8. A device according to any claim 1, further comprising a mechanism for actuating the expelling means.

9. A device according to claim 1, wherein the cartridge and the base member are hinged relative to one another thereby allowing relative movement therebetween from an initial configuration to a working configuration.

10. A device according to claim 9, further comprising a mechanism for actuating the expelling means and wherein said relative movement operates the mechanism for actuating the expelling means.

11. A device according to claim 9, wherein said relative movement the hinge causes the establishment of fluid communication between the drug compartment and the delivery needle.

12. A device according to claim 9, wherein the hinge enable the cartridge and the base member to be pressed towards one another from a spaced-apart initial configuration to an adjacent working configuration.

13. A device according to claim 1, wherein the skin-contacting surface is provided with an aperture through which the delivery needle extends in use.

14. A device according to claim 1 in which a portion of the interior of the cartridge defines a drug compartment for the drag and the device is provided with a conduit enabling fluid communication to be established in use between the drug compartment and the delivery needle, wherein an end of the cartridge is provided with a stopper and the conduit and stopper are located proximate to one another, and prior to use, the conduit penetrates through the stopper and thereby establishes said communication.

15. A device according to claim 14, wherein the needle assembly is fixed with respect to the cartridge, and the stopper moves relative to both the cartridge and the needle assembly.

16. A device according to claim 15, wherein the actuation of the expelling means creates increased pressure within the drug compartment which causes the stopper to press against and penetrate the conduit.

17. A device according to claim 15, wherein the stopper is fixed with respect to the cartridge, and the needle assembly moves relative to both the cartridge and the stopper.

18. A device according to claim 1, wherein the expelling means comprises a pre-compressed spring.

19. A device according to claim 18 and further comprising a mechanism for actuating the expelling means, wherein the mechanism for actuating the expelling means comprises a catch which when released enables the pre-compressed spring to relax.

20. A device according to claim 19, wherein the connection between the cartridge and the base member allows relative movement therebetween from an initial configuration to a working configuration and wherein said relative movement causes the catch to be released.

21. A device according to claim 1, wherein the expelling means comprises a gas generator which generates a gas when two or more reactants are brought into contact.

22. A device according to claim 21, wherein the gas generator comprises at least one liquid.

23. A device according to claim 22, wherein the gas generator comprises the components of an effervescent couple.

24. A device according to claim 1, wherein the expelling means comprises a material which swells in the presence of a liquid, and also comprises a supply of said liquid.

25. A device according to claim 24, wherein said material is a swellable gel and said liquid is water.

26. A device according to claim 8 in which the expelling means comprises a material which swells in the presence of a liquid or a gas generator which generates a gas when two or more reactants, at least one reactant comprising a liquid, are brought into contact, wherein said liquid is contained within a rupturable compartment and the mechanism for actuating the expelling means comprises a penetrating member, the penetrating member and the rupturable compartment being moved relative to one another upon the relative movement of the cartridge and the base member, so as to cause the penetration of said rupturable compartment and the actuation of the expelling means.

27. A device according to claim 9, further comprising a snap mechanism which maintains a stable initial configuration and a stable working configuration and which when actuated causes the device to snap from said initial configuration to said working configuration.

28. A device according to claim 27, further comprising resilient means biasing the device to said initial configuration and means for disengaging said snap mechanism when delivery has been completed.

29. A device according to claim 28, wherein a portion of the interior of the cartridge defines a drug compartment for the drug, the drug being expelled from the compartment by a piston actuated by the expelling means and wherein said disengaging means comprises a member linked to said piston such that when the piston has completed the expulsion of drug from the drug compartment, said member is caused to move and said movement causes the disengagement of said snap mechanism, such that said resilient means causes the device to resume said initial configuration.

30. A device according to claim 29, wherein the delivery needle is in the shape of a segment of arc of an imaginary circle, said circle having a radius equal to the distance between the delivery needle and the hinge and lying in a plane which is substantially normal to the plane of the skin-contacting surface.

31. A device according to claim 1, wherein the delivery needle is straight.