Drug delivery systems and methods

• US 20040015134A1
• Filed: 07/14/2003
• Published: 01/22/2004
• Est. Priority Date: 11/13/1998
• Status: Abandoned Application

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Lavi, Gilad, Gross, Joseph, Tsals, Izrail, Yigal, Gil
• Application Number:
  US10/618,894
• Publication Number:
  US 20040015134A1
• Time in Patent Office: Days
• US Class Current: 604/183
• 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 is 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. An injection device comprising:

a housing having a penetrating member aperture,

a port in said housing that receives a rigid container that contains an injectable drug;

a first penetrating member movable from a storage position in the housing to an injection position extending outside the housing through the aperture; and

a channel that brings said penetrating member into fluid communication with the first container.

2. The injection device of claim 1 wherein the channel comprises a fluid pathway in a manifold, the manifold further comprising a second channel to transfer the injectable drug from the housing to the user.

3. The injection device of claim 1 further comprising an actuator that displaces the penetrating member from the storage position to the injection position.

4. The injection device of claim 3 wherein the actuator includes a plunger mechanism on a first housing surface that displaces said first penetrating member through the aperture on a second housing surface between the storage position and the injection system.

5. The device of claim 1 further comprising a locking mechanism that prevents displacement of said first penetrating member to said injection position after injection.

6. The injection device of claim 1 further comprising a biasing mechanism that resiliently biases the penetrating member in said storage position.

7. The injection device of claim 1 further comprising a penetrating member retraction system that retracts said penetrating member into the housing after injection.

8. The injection device of claim 1 wherein the penetrating member extends in the range of 5-12 millimeters out of said housing in said injection position for a subcutaneous injection.

9. The injection device of claim 1 wherein the penetrating member extends up to about 3 cm out of said housing in said injection position for an intermuscular injection.

10. A drug injection device comprising:

a housing having a port that receives a container of injectable fluid;

a pressurizing mechanism that pressurizes the container to move the injectable fluid; and

a penetrating member movable from a storage position in the housing to an injection position extending outside the housing, the penetrating member being in fluid communication with the container.

11. The device of claim 10 further comprising a sealing member to maintain the injectable fluid in an upper end of the housing.

12. The device of claim 11 wherein the sealing member further comprises a membrane that is gas impermeable.

13. The device of claim 11 wherein the injection penetrating member includes a first end to pierce skin of the body being injected and a second end to pierce the sealing member after the first end has penetrated the skin.

14. The device of claim 10 further comprising an actuator that displaces the injection penetrating member between the storage position and the injection position.

15. A method of drug delivery comprising the steps of:

providing a housing having a first port that receives a first container of injectable fluid;

pressurizing the fluid in the container; and

moving an injection penetrating member from a storage position to an injection position, the injection penetrating member being in fluid communication with the first container.

16. The method of claim 15 further comprising the steps of:

providing a movable member slidable and sealingly positioned within the first port, the movable member fixedly supporting a first penetrating member in fluid communication with the container; and

collapsing a collapsible volume with the movable member upon insertion of the first container into the first port, the collapsible volume being in sealed communication with the first penetrating member to pressurize the container.

17. The method of claim 15 further comprising a second port in the housing that receives a second container that pressurizes the fluid in the first container as said second container contains a fluid to be transferred into the first container, further comprising the step of pressurizing the first container upon transfer of the fluid.

18. The method of claim 15 further comprising the step of penetrating the body with a first end of the injection penetrating member and then coming into fluid communication with the injectable fluid with a side opening of the injection penetrating member.

19. The method of claim 15 further comprising the step of retracting and locking the injection penetrating member within the housing after injection.

20. The method of claim 15 further comprising providing a gas impermeable membrane along at least a portion of a fluid path between the container and the penetrating member.

21. The method of claim 15 further comprising providing a compressible volume, and compressing the volume to pressurize the container.