Drug delivery systems and methods

• US 6,364,865 B1
• Filed: 11/12/1999
• Issued: 04/02/2002
• Est. Priority Date: 11/13/1998
• Status: Expired due to Fees

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Lavi, Gilad, Tsals, Izrail, Gross, Joseph, Yigal, Gil
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/439,614
• Time in Patent Office: 872 Days
• Field of Search: 604/264, 604/191, 604/407, 604/411, 604/232, 604/518, 604/82, 604/86, 604/87, 604/412-415, 141/25-27, 141/105, 141/107, 141/329, 141/375
• US Class Current: 604/411
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2017 having three or more piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3223 Means impeding or disabling repositioning of used needles at the syringe nozzle
• CPC Class Codes: A61M 2205/215 Tilt detection, e.g. for warning or shut-off
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• 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 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/2448 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3234 : Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user

Abstract

The present invention relates to a drug delivery device for mixing and delivering a drug by injection. The device includes a housing having a first port or opening therein that receives a first container that contains a fluid or powdered drug, for example a lyophilized drug. The housing can also include a second port or opening that receives a second container that contains a fluid to be mixed with the drug to form an injectable fluid. The device includes a manifold having a channel that fluidly connects the first and second containers. A penetrating membrane such as a needle s used to inject the drug into a patient which is in fluid communication with the first container. The needle is movable from a storage position in the housing to an injection position extending through the housing.

Claims

1. A transfer system comprising:

a housing;

a first port in said housing that receives a first container having first contents therein;

a second port in said housing that receives a second container that contains a second contents to be mixed with the first contents to form a material;

a pressure source in communication with the second container upon activation;

a first channel that enables the second contents from the second container to move to the first container; and

an activator.

2. The system of claim 1 further comprising a second channel to transfer the material.

3. The system of claim 1 further comprising an interlock such that the first container must be received by the first port before the second container can be received by the second port.

4. The system of claim 1 further comprising a first penetrating member fixed to said housing and that penetrates said first container.

5. The system of claim 1 further comprising a second penetrating member fixed to said housing and that penetrates said second container.

6. The system of claim 1 wherein the material is a drug that is transferred with a needle into tissue.

7. The system of claim 1 wherein the material is a drug that is transferred to a drug delivery device.

8. The system of claim 7 wherein the actuator includes a pressure source.

9. The system of claim 1 further comprising a support surface on the housing such that the first and second containers are received along axes extending orthogonal to the support surface.

10. The system of claim 1 wherein the contents of the first container is a solid material.

11. The system of claim 1 further comprising a metering element that controls a volume of the drug being transferred.

12. The system of claim 8 wherein the metering element includes a penetrating member that extends an adjustable distance into the first container.

13. The system of claim 1 further comprising a position indicator that indicates a position of the first container.

14. The system of claim 1 further comprising a transfer indicator that indicates movement of the drug within the housing.

15. The system of claim 1 further comprising a membrane that impedes the transfer of a gas.

16. The system of claim 1 further comprising a support surface on the housing such that a user can insert the first container and the second container with one hand while the housing is positioned with the support surface.

17. The system of claim 7 wherein the solid material is a lyophilized drug.

21. The method of claim 16, further comprising providing a first contents that is a liquid drug.

22. The method of claim 16 further comprising providing a first contents that is a powder.

23. The method of claim 16 further comprising providing a first contents that is a lyophilized drug.

24. The method of claim 16 wherein a user inserts the first container and the second container into the housing using one hand.

25. The method of claim 16 further comprising providing an interlock such that the first container must be inserted before the second container.

26. The method of claim 16 further comprising providing a position indicator that indicates a position of the housing to a user.

27. The method of claim 16 further comprising providing a transfer indicator that indicates a movement of the solution to a user.

28. The method of claim 16 further comprising a membrane that prevents movement of a gas.

29. The system of claim 1 wherein the longitudinal axes of the first and second containers are oriented vertically.

30. The system of claim 1 wherein the pressure source is only in communication with the second container.

31. The system of claim 1 wherein the second channel only communicates between the second container and the first container.

32. The system of claim 10 wherein the solid material comprises a powder.

18. A method for forming a drug comprising:

providing a housing that receives a first container having a first contents therein and that receives a second container having a second contents therein, and that has a first channel that enables the second contents from the second container to move to the first container upon activation, and a pressure source in communication with the second container upon activation, and an activator;

inserting first container and the second container into the housing;

activating the pressure source thereby moving the second contents from the second container into the first container along the first channel in the housing to form a solution in the first container.

19. The method of claim 18 further comprising the step of transferring the solution from the first container.

20. The method of claim 19 wherein the step of pressurizing the second container includes the use of one of a compressed air container, a changeable volume container, a syringe, and a chemical gas generator.