Drug delivery systems and methods

• US 6,478,771 B1
• Filed: 11/12/1999
• Issued: 11/12/2002
• 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): Casler, Brian L.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/439,963
• Time in Patent Office: 1,096 Days
• Field of Search: 604/82, 604/83, 604/85, 604/86, 604/87, 604/88, 604/89, 604/92, 604/93.01, 604/191, 604/232, 604/84
• US Class Current: 604/82
• 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. A fluid injection device comprising:

a housing comprising a first port, a second port and a skin-penetrating member aperture;

said first and second ports being in fluid communication with each other through a first channel in said housing;

said first port receiving a first container containing a solid compound therein;

said second port receiving a second container containing a fluid therein, said fluid being movable through said first channel and into said first container to form a mixture of said solid compound and said fluid in said first container;

a movable second channel being movable to be in fluid communication with said mixture in said first container; and

a skin-penetrating member movable from a storage position in said housing to an injection position extending outside said housing through said skin-penetrating member aperture.

2. The device of claim 1 wherein said housing further comprises an actuator that displaces said skin-penetrating member from the storage position to the injection position, said actuator including a plunger mechanism on a first housing surface that displaces said skin-penetrating member through said aperture on a second housing surface between the storage position and the injection position.

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

4. The device of claim 1 further comprising a locking mechanism that prevents movement of said skin-penetrating member to said injection position before the second container is inserted into said first port.

5. The device of claim 1 further comprising a locking mechanism that prevents movement of said skin-penetrating member to the injection position when said first container is not vertically oriented.

6. The device of claim 1 wherein said housing further comprises:

a second penetrating member fixed to said housing and that penetrates said second container;

a third penetrating member fixed to said housing and that penetrates said first container; and

a compression element in said housing that displaces the fluid in said second container.

7. The device of claim 6 further comprising a displaceable sealing element in said second container that is moved by said compression element, and is penetrated by said second penetrating member, upon insertion of said second container into said second port, said penetration of said displaceable sealing element and said movement of said displaceable sealing element transferring the fluid into said first channel.

8. The device of claim 1 comprising a biasing mechanism that resiliently biases said skin-penetrating member in said storage position.

9. The device of claim 1 further comprising a second and third penetrating member fixed to said housing that penetrates said first and second containers, respectively, said second and third penetrating members forming opposite ends of said first channel.

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

11. The device of claim 1 wherein said fluid is transferred into the first container upon insertion of the second container into the second port.

12. The device of claim 1 wherein the first container comprises a light transmissive vial having a visible surface when connected to the first port.

13. The device of claim 1 wherein said first container is oriented at a perpendicular angle relative to an injection axis of skin-penetrating member during injection.

14. The device of claim 1 wherein a compressed fluid, provided in said second container upon insertion of said second container into said second port, is used to inject said fluid.

15. The device of claim 1 wherein said housing is a single integrally molded housing.

16. The device of claim 1 wherein said first and second containers comprise vials having a two milliliter volume.

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

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

19. The device of claim 1 wherein the solid compound is a powdered drug.

20. The device of claim 1 further comprising an interlocking mechanism that prevents insertion of said second container before insertion of said first container into the housing.

21. The device of claim 1 wherein the solid compound for injection is a lyophilized drug.

22. The device 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.

23. A method of fluid injection comprising the steps of:

providing a housing member having a skin-penetrating member aperture;

providing a first port in said housing that receives a first container that contains a solid compound for injection;

inserting said first container in said housing;

providing a second port in said housing that receives a second container that contains a fluid;

inserting said second container in said housing;

providing a first channel in fluid communication between the first and second containers to permit the transfer of said fluid into said first container to form a mixture of said solid compound and said fluid in said first container;

coupling a skin-penetrating member in fluid communication with said mixture in said first container; and

injecting said mixture at an injection site with said skin-penetrating member extending through said skin-penetrating member aperture.

24. The method of claim 23 further comprising the step of displacing said skin-penetrating member between a storage position within said housing and an injection position outside said housing.

25. The method of claim 24 further comprising the step of locking said skin-penetrating member in said storage position after injection.

26. The method of claim 24 wherein said step of providing a first channel comprises the steps of:

providing a second penetrating member fixed to said housing and configured to penetrate said second container;

providing a third penetrating member fixed to said housing and configured to penetrate said first container; and

fluidly connecting said second and third penetrating members through said first channel.

27. The method of claim 24 further comprising the step of extending skin-penetrating member out of the housing in the range of 5-12 millimeters in said injection position.

28. The method of claim 23 further comprising the step of forcing said fluid from said second storage container into said first container upon inserting said second container into said second port such that said mixture is pressurized in said first container.

29. The method of claim 23 wherein said step of providing a first channel comprises the steps of:

providing a second and third penetrating member fixed to said housing that penetrates that first and second containers respectively; and

fluidly connecting said second and third penetrating members through said first channel.

30. The method of claim 23 further comprising the step of preventing movement of said skin-penetrating member to said injection position before said second container is inserted into said second port.

31. The method of claim 23 further comprising the step of preventing displacement of said skin-penetrating member to the injection position when said first container is not vertically oriented.

32. A drug delivery device comprising:

a housing having a skin-penetrating member aperture;

a first port in said housing that receives a first vial that contains a first drug component;

a second port in said housing that receives a second vial that contains a second drug component to be mixed with said first drug component to form a mixture;

a manifold that fluidly connects said first and second vials;

a skin-penetrating member movable from a first position inside the housing to a second position extending outside the housing through the skin-penetrating member aperture; and

an actuator which causes the manifold to come into fluid communication with the skin-penetrating member.

33. The device of claim 32 further comprising a locking mechanism that prevents displacement of said skin-penetrating member to said second position after a single injection.

34. The device of claim 32 further comprising a biasing mechanism that resiliently biases said skin-penetrating member in said first position.

35. The device of claim 32 further comprising a penetrating member retraction system that retracts said skin-penetrating member into the housing after injection.

36. The device of claim 32 wherein said skin-penetrating member extends outside of the housing to establish fluid communication with the first vial.

37. The device of claim 32 wherein said second drug component is transferred under pressure into the first vial upon insertion of the second vial into the second port.

38. The device of claim 32 wherein the first vial comprises glass which is visible during transferring of the second drug component and during injection.

39. The device of claim 32 wherein said mixture in said first vial is pressurized to inject said mixture.

40. The device of claim 32 wherein the first drug component is a lyophilized drug.

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

providing a housing having a skin-penetrating member aperture;

providing a first port that receives a first vial that contains a first drug component;

providing a second port that receives a second vial that contains a second drug component to be mixed with said first drug component to form a mixture in said first vial;

providing a manifold fluidly connecting said first and second vials;

providing a skin-penetrating member movable from a first position inside the housing to a second position outside the housing through the skin-penetrating aperture; and

causing the manifold to come into fluid communication with said mixture in said first vial and said skin-penetrating member.

42. The method of claim 41 further comprising the step of locking said skin-penetrating member in the first position after injection.

43. The method of claim 41 further comprising the step of retracting said skin-penetrating member to the first position after injection.

44. The method of claim 41 further comprising the step of preventing movement of said skin-penetrating member before said second vial is inserted into said second port.

45. The method of claim 41 further comprising the step of preventing movement of said skin-penetrating member when the first vial is not vertically oriented.

46. A drug delivery device comprising:

a housing having a skin-penetrating member aperture and a first port that receives a first container that contains a solid compound;

a second port in said housing that receives a second container that contains a fluid to be transferred into said first container to form a mixture;

a pressurizing mechanism that pressurizes said mixture in said first container; and

a skin-penetrating member movable from a storage position in said housing to an injection position extending through said skin-penetrating member aperture outside said housing, said skin-penetrating member being in fluid communication with said mixture in said first container.

47. The device of claim 46 further comprising a sealing member to maintain said mixture in said first container in an upper end of said housing.

48. The device of claim 47 wherein said skin-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.

49. The device of claim 46 further comprising an actuator that displaces said skin-penetrating member between the storage position and the injection position.

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

providing a housing having a skin-penetrating member aperture and a first port that receives a first container that contains a solid compound;

providing a second port in said housing that receives a second container that contains a fluid that is transferred into said first container to form a mixture;

pressurizing said mixture in said first container; and

moving a skin-penetrating member from a storage position to an injection position, said skin-penetrating member being in fluid communication with said mixture in said first container; and

penetrating the body of a living being with a first end of said skin-penetrating member and then coming into fluid communication with said mixture with a second end of skin-penetrating member.