Reconstitution and injection system

• US 20030036725A1
• Filed: 09/20/2001
• Published: 02/20/2003
• Est. Priority Date: 09/21/2000
• Status: Abandoned Application

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Bar-Or, Jonathan, Yigal, Gjl, Lavi, Gilad
• Application Number:
  US09/957,179
• Publication Number:
  US 20030036725A1
• Time in Patent Office: Days
• US Class Current: 604/91
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/208 Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2205/582 by tactile feedback
• 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 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Abstract

This reconstitution and injection system delivers a drug in solution under pressure, and injects powdered or lyophilized drugs that require reconstitution, rehydration or dilution. In one embodiment, the system includes a syringe having a barrel, a plunger, a handle, a pump and a channel communicating the barrel with an injection needle. The pump pushes a liquid from the barrel through the injection needle via the channel upon fluid communication between the barrel and the injection needle for delivery of the liquid. In another embodiment, the system includes a first port receiving a syringe, a second port receiving a drug vial, a channel providing communication between the first and second ports, and a controller permitting or inhibiting fluid communication between the first and second ports. In yet another embodiment, the system includes an actuator and a housing having a channel providing fluid communication between a reservoir and the injection needle.

Claims

1. A drug delivery device, comprising:

a syringe having a barrel, a plunger, a handle and a pump, said barrel having a drug reservoir therein, said reservoir being arranged to have a liquid therein, said plunger slidingly located within said barrel and coupled to said plunger, and said pump located between said plunger and said handle; and

a first channel arranged for selectively providing fluid communication between said drug reservoir and a hollow needle,

said pump being arranged to drive the liquid from the drug reservoir through said needle via said first channel upon said fluid communication between said drug reservoir and said needle to deliver the liquid to a site.

2. The drug delivery device of claim 1, wherein said pump comprises a compression spring.

3. The drug delivery device of claim 1, wherein said handle includes clips arranged to couple said handle to said barrel to at least temporarily place said pump in a compressed state between said plunger and said handle.

4. The drug delivery of claim 1, wherein said pump biases said plunger to drive the liquid from said drug reservoir through said needle via said first channel upon said fluid communication between said drug reservoir and said needle.

5. The drug delivery device of claim 1, additionally comprising a vial receptacle arranged to receive a vial and a housing, and wherein said first channel is located in said housing, said housing including a second channel arranged for selectively providing fluid communication between said drug reservoir and the vial in said vial receptacle.

6. The drug delivery device of claim 5, wherein said vial receptacle includes a spiking needle having a first end communicating with said second channel and a second end arranged for selectively providing fluid communication with the interior of the vial in said vial receptacle.

7. The drug delivery device of claim 5, wherein said device further comprises a pathway controller arranged for inhibiting fluid communication between said drug reservoir and the interior of the vial.

8. The drug delivery device of claim 7, wherein said pathway controller includes a stem slidingly engaged within said second channel to permit fluid communication between said drug reservoir and the interior of the vial when said pathway controller is in a first position and to inhibit fluid communication between said drug reservoir and the interior of the vial when said pathway controller is in a second position.

9. The drug delivery device of claim 7, wherein said pathway controller includes a stem rotatably engaged within said housing and adjacent said second channel to permit fluid communication between said drug reservoir and the interior of the vial when said pathway controller is in a first position and to inhibit fluid communication between said drug reservoir and the interior of the vial when said pathway controller is in a second position.

10. The drug delivery device of claim 9, wherein said pathway controller comprises an arm extending from said pathway controller such that when said pathway controller is in the second position said arm abuts the vial to inhibit removal of the vial from said housing and said stem allows fluid communication between said drug reservoir and said injection needle.

11. The drug delivery device of claim 5, wherein said housing includes an interlocking arm that releasably secures the vial to said housing.

12. The drug delivery device of claim 1, further comprising an actuator coupled to said housing, said actuator arranged for aligning an opening in said needle with said first channel to permit the fluid communication between said drug reservoir and said needle.

13. The drug delivery device of claim 12, wherein said actuator includes a hub that holds said needle, said hub being arranged for moving said needle from a first position where said opening in said needle is not in fluid communication with said drug reservoir to a second position where the opening in said needle is in fluid communication with said drug reservoir.

14. The drug delivery device of claim 13, wherein said needle comprises a tip that is concealed by said drug delivery device when said needle is in said first position and is exposed when said needle is in said second position.

15. The drug delivery device of claim 13, further comprising a second pump located between said housing and said actuator, said second pump being arranged to bias said actuator such that said needle is concealed by said drug delivery device upon completion of the delivery of the liquid to the injection site.

16. The drug delivery device of claim 15, wherein said second pump comprises a compression spring.

17. The drug delivery device of claim 13, wherein said actuator includes an actuator housing and a shield, said actuator housing having a first end coupled to the housing and a second end adjacent said shield, said shield arranged to conceal said tip of said needle when said needle is in said first position.

18. The drug delivery device of claim 17, further comprising a second pump located between said housing and said hub, said second pump being arranged to bias said hub to push said needle from said first position to said second position.

19. The drug delivery device of claim 18, wherein said second pump is a helical compression spring.

20. The drug delivery device of claim 18, further comprising a latch coupled to said actuator and said hub, said latch being arranged to activate said second pump to push said needle to said second position.

21. The drug delivery device of claim 18, further comprising a third pump located between said housing and said shield, said third pump being arranged to bias said shield such that said needle is concealed by said drug delivery device upon completion of the delivery of the liquid to the injection site.

22. The drug delivery device of claim 21, wherein said second and third pumps comprise compression springs.

23. The drug delivery device of claim 1, wherein said needle is an injection needle.

24. The drug delivery device of claim 23, wherein said injection needle has a penetration length of about 7 mm.

25. The drug delivery device of claim 1, wherein the site of delivery is to or through the skin of a mammal.

26. The drug delivery device of claim 1, wherein said needle has a gage of about #26.

27. A syringe, comprising:

a barrel having a drug reservoir therein, said drug reservoir being arranged to hold a liquid therein;

a plunger slidingly engaged within said barrel;

a handle coupled to said plunger; and

a pump located between said plunger and said handle, said drug reservoir and a needle being arranged to be selectively placed in fluid communication with each other, said pump arranged for driving the liquid from said drug reservoir through said needle upon said fluid communication between said drug reservoir and said needle for delivery of the liquid to a site.

28. The syringe of claim 27, wherein said pump comprises a compression spring.

29. The syringe of claim 27, wherein said handle includes at least one clip arranged to couple said handle to said barrel to at least temporarily place said pump in a state of potential energy between said plunger and said handle.

30. The syringe of claim 27, wherein said pump is arranged to bias said plunger to drive the liquid from said drug reservoir through said needle upon fluid communication between said drug reservoir and said needle.

31. The syringe of claim 27, wherein said plunger comprises a piston coupled to a rod, said piston forming a sliding seal within said barrel, said rod slidingly engaged within said handle and having a proximal end arranged to snap-fit said handle.

32. The syringe of claim 27, wherein said needle is an injection needle.

33. The syringe of claim 27, wherein the site of delivery is to or through the skin of a mammal.

34. The syringe of claim 27, wherein said needle has a penetration length of about 7 mm.

35. The syringe of claim 27, wherein said needle has a gage of about #26.

36. A mixing device coupled to a syringe, the syringe having a drug reservoir therein, said mixing device comprising:

a first port arranged for receiving the syringe, the syringe having a barrel coupled to or integral with said first port, the barrel having a drug reservoir therein, the drug reservoir being in fluid communication with said first port;

a second port arranged for receiving a vial, the vial having an interior in fluid communication with said second port;

a first channel arranged for selectively communicating said first port with said second port; and

a pathway controller in fluid communication with the first channel and between said first and second ports, said pathway controller arranged for permitting the fluid communication between said first and second ports when said controller is in a first position and for inhibiting the fluid communication between said first and second ports when said controller is in a second position.

37. The mixing device of claim 36, wherein said second port includes a spiking needle having a first end communicating with said first channel and a second end arranged for selectively providing fluid communication with the interior of the vial in said vial receptacle.

38. The mixing device of claim 36, wherein said pathway controller comprises a stem slidingly engaged within said first channel.

39. The mixing device of claim 36, wherein said pathway controller comprises a stem rotatably engaged within said mixing device and adjacent said first channel.

40. The mixing device of claim 39, wherein said pathway controller comprises an arm extending from said pathway controller such that when said pathway controller is in said second position, said arm abuts the vial to inhibit removal of the vial from said mixing device.

41. The mixing device of claim 36, further comprising:

a third port arranged for receiving an actuator, said actuator comprising a needle, and

a second channel between said first port and said third port for communicating said drug reservoir with said needle.

42. The mixing device of claim 41, wherein said actuator includes a hub that holds the needle, said hub being arranged for moving said needle from a first position where the opening in said needle is not in fluid communication with said second channel to a second position where the opening in said needle is in fluid communication with said second channel.

43. The mixing device of claim 42, wherein said needle is an injection needle.

44. A drug delivery apparatus, comprising:

an actuator having a hub and a hollow needle, said hub holding said needle, said needle having a tip at its distal end and an opening proximal to the tip; and

a housing coupled to said actuator, said housing including a channel arranged to selectively provide fluid communication between a liquid reservoir holding a liquid and said needle, wherein

said hub is arranged for moving said needle from a first position where said opening in said needle is not in fluid communication with said channel to a second position where said opening in said needle is in fluid communication with said channel to deliver a liquid from the liquid reservoir.

45. The drug delivery apparatus of claim 44, wherein said needle is an injection needle.

46. The drug delivery apparatus of claim 45, wherein said injection needle has a penetrating length of about 7 mm.

47. The drug delivery apparatus of claim 45, wherein said injection needle comprises a tip, and said tip of said injection needle is concealed by said drug delivery apparatus when said injection needle is in said first position and is exposed when said injection needle is in said second position.

48. The drug delivery apparatus of claim 47, wherein said injection needle has a penetration length of about 7 mm.

49. The drug delivery apparatus of claim 44, wherein said actuator further comprises a pump located between said housing and said hub, said pump being arranged to bias said hub such that said tip of said needle is concealed by said drug delivery apparatus upon completion of the delivery of the liquid.

50. The drug delivery apparatus of claim 49, wherein said pump comprises a compression spring.

51. The drug delivery apparatus of claim 44, wherein said actuator further includes an actuator housing and a shield, said actuator housing having a first end coupled to said housing and a second end adjacent said shield, said shield being arranged to conceal said needle when said needle is in said first position.

52. The drug delivery apparatus of claim 51, wherein said actuator further comprises a first pump located between said housing and said hub, said first pump being arranged to bias said hub to push said needle from said first position to said second position beyond said shield.

53. The drug delivery apparatus of claim 52, wherein said first pump comprises a compression spring.

54. The drug delivery apparatus of claim 52, wherein said actuator further includes a second pump located between said housing and said shield, said second pump being arranged to bias said shield and push said shield away from said housing such that said needle is concealed by said shield upon completion of the delivery of the liquid.

55. The drug delivery apparatus of claim 54, wherein said first and second pumps comprise compression springs.

56. The drug delivery apparatus of claim 52, further comprising a latch coupled to said actuator and said hub, said latch being arranged to activate said first pump to push said needle to said second position.

57. A method of ejecting a fluid from a barrel of a syringe having a handle, a barrel, a plunger and a needle, said barrel having the fluid therein, said needle being hollow, the method comprising:

securing said handle of the syringe to said barrel to bias said plunger against said fluid in said barrel placing said fluid under pressure; and

actuating a movement of said needle to place the hollow interior of said needle in fluid communication with said fluid whereupon said plunger automatically pushes said fluid through said needle.

58. A method of mixing a drug in a vial with a liquid from a reservoir, comprising:

(a) establishing fluid communication between a control valve and the interior of said vial, the interior of said vial containing a drug;

(b) adjusting said control valve to selectively establish fluid communication between said liquid in said reservoir and the interior of said drug vial via said control valve, said reservoir being in fluid communication with said control valve; and

(c) transferring said liquid to the interior of said drug vial, said liquid mixing with said drug to form a drug compound.

59. The method of claim 58, further comprising:

transferring said drug compound to said reservoir;

adjusting said control valve to cease fluid communication between said reservoir and the interior of said drug vial;

terminating fluid communication between said control valve and the interior of said drug vial;

establishing fluid communication between said control valve and the interior of another drug vial, the interior of said other drug vial containing another material;

adjusting the control valve to establish fluid communication between the reservoir and the interior of the other drug vial; and

transferring said drug compound to the interior of said other drug vial, the drug compound mixing with said other material to form a reconstituted drug compound.

60. The method of claim 58, prior to step (a), further comprising:

adjusting said control valve to establish fluid communication between said reservoir and the interior of a diluent vial having the liquid therein;

aspirating the liquid into said reservoir;

adjusting said control valve to cease fluid communication between said reservoir and the interior of said diluent vial; and

terminating fluid communication between said control valve and the interior of said diluent vial.

61. A method of ejecting a liquid from a barrel of a syringe, said syringe comprising a needle, a plunger located within the barrel and having a stem and a handle, comprising:

depressing said handle of said plunger to cause said plunger to slide within the barrel to couple said handle to said barrel to place said liquid under pressure; and

actuating a movement of said needle within said syringe for insertion into an injection site, the movement of the needle establishing fluid communication between an interior of the needle and said liquid which releases the pressure of said liquid in said barrel and enables said plunger to push said liquid through the needle to the injection site.

62. The method of claim 61, wherein a compression pump is associated with said syringe, and depressing the handle of said plunger causes said compression pump to pressurize said liquid.

63. The method of claim 62, wherein said compression pump comprises a spring, and said method comprises compressing said spring.

64. A method of ejecting a liquid from a barrel of a syringe, said syringe comprising a hollow needle, a plunger, and a compression pump, said method comprising:

applying a bias against said plunger in communication with said liquid to place the liquid under pressure; and

actuating a movement of said needle within said syringe for insertion into an injection site, the movement of said needle establishing fluid communication between the hollow interior of said needle and said liquid which releases the pressure of said liquid in said barrel and enables said compression pump to push said plunger within said barrel and force said liquid through the needle.

65. The method of claim 64, wherein the bias is applied by depressing said compression pump against the plunger.

66. The method of claim 65, wherein the compression pump comprises a spring, and said spring is operated to compress it.

67. A method of mixing a drug in a vial with a liquid from a reservoir to form a drug compound, and ejecting the drug compound from a reservoir in an drug delivery device, said drug delivery device having a needle, a plunger located within the reservoir, and a control valve therebetween, the method comprising:

(a) adjusting said control valve to establish fluid communication between the liquid in said reservoir and an interior of said drug vial via said control valve, the interior of said drug vial containing the drug;

(b) transferring the liquid from said reservoir to the interior of said drug vial, the liquid mixing with the drug to form the drug compound;

(c) transferring the drug compound to said reservoir;

(d) adjusting said control valve to terminate fluid communication between said reservoir and the interior of said drug vial;

(e) biasing said plunger against the drug compound in said reservoir to place the drug compound under pressure; and

(f) actuating a movement of said needle, the movement of said needle establishing fluid communication between the interior of said needle and the drug compound, the communication releasing the pressure of the drug compound in said reservoir and enabling said plunger to push the drug compound through said needle.