Needle-free injection device

• US 20060089594A1
• Filed: 06/13/2005
• Published: 04/27/2006
• Est. Priority Date: 10/26/2004
• Status: Abandoned Application

• Current Assignee: Bioject Incorporated
• Original Assignee: Bioject Incorporated
• Inventors: Landau, Sergio
• Application Number:
  US11/152,688
• Publication Number:
  US 20060089594A1
• Time in Patent Office: Days
• US Class Current: 604/68
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2037 having valve means
• CPC Class Codes: A61J 1/2044 having slits
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2205/11 with means for preventing cross-contamination when used for multiple patients
• CPC Class Codes: A61M 2205/583 by visual 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 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod
• CPC Class Codes: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321

Abstract

The disclosure provides a filling cap for use in a needle-free injection system. The filling cap includes a vial-engagement portion and a needle-free syringe-engagement portion with a frangible portion extending therebetween. The vial-engagement portion is designed to removably engage a vial of fluid to be transferred into a needle-free syringe, and the needle-free syringe-engagement portion is designed to nonremovably engage a needle-free syringe.

Claims

1. A filling cap for use in a needle-free injection system comprising a vial-engagement portion and a needle-free syringe-engagement portion, with a frangible portion extending therebetween, the vial-engagement portion designed to removably engage a vial of fluid to be transferred into a needle-free syringe, the needle-free syringe-engagement portion designed to nonremovably engage an needle-free syringe.

2. The filling cap of claim 1, further comprising means for preventing the needle-free syringe from being filled more than once.

3. The filling cap of claim 1, further comprising a plurality of extensions or depressions facing outwardly from the needle-free syringe that prevent the needle-free syringe from being used more than once.

4. The filling cap of claim 1 wherein the needle-free syringe-engagement portion includes a non-smooth surface facing outwardly from the needle-free syringe to minimize the likelihood of the needle-free syringe being used more than once.

5. The filling cap of claim 1 wherein the needle-free syringe-engagement portion includes at least one raised member facing outwardly from the needle-free syringe to minimize the likelihood of the needle-free syringe being used more than once.

6. The filling cap of claim 5, further comprising a plurality of raised members facing outwardly from the needle-free syringe to minimize the likelihood of the needle-free syringe being used more than once.

7. The filling cap of claim 1 wherein the needle-free syringe-engagement portion includes at least one undercut portion facing outwardly from the needle-free syringe to minimize the likelihood of the needle-free syringe being used more than once.

8. The filling cap of claim 7 in which the undercut portion is a slot.

9. The filling cap of claim 7, further comprising at least one raised member facing outwardly from the needle-free syringe to minimize the likelihood of the needle-free syringe being used more than once.

10. The filling cap of claim 1 wherein the vial-engagement portion includes a recess designed to compliment the configuration of a vial adaptor having an outwardly extending member, such that the recess receives the outwardly extending member.

11. The filling cap of claim 1 wherein the needle-free syringe-engagement portion includes a centrally-disposed solid portion facing the needle-free syringe.

12. The filling cap of claim 1 wherein the needle-free syringe-engagement portion includes at least one outwardly-facing, off-center aperture.

40. The filling cap of claim 1, wherein the vial-engagement portion includes a plurality of resilient fingers designed to engage the vial.

41. The filling cap of claim 1, wherein the vial-engagement portion includes a spike configured to pierce a covering on the vial and permit fluid to be drawn from the vial through the spike.

13. A method for filling a needle-free injector with injection fluid comprising the following steps, but not necessarily in the order recited:

selecting a needle-free syringe having an injection orifice at one end;

selecting a vial with injection fluid therein;

mounting one end of a vial adaptor to the vial such that a second end of the vial adapter faces away from the vial;

selecting a filling cap with one end complementing the configuration of the one end of the needle-free syringe and the other end complimenting the configuration of the second end of the vial adaptor, and having a frangible portion disposed between the two ends;

nonremovably fixing the one end of the filling cap to the one end of the needle-free syringe;

mounting the other end of the filling cap to the second end of the vial adaptor;

transferring injection fluid from the vial to the needle-free syringe; and

breaking the frangible portion of the filling cap without removing the one end from the needle-free syringe.

14. The method of claim 13 wherein the step of breaking the frangible portion of the filling cap is performed without removing the other end of the filling cap from the vial adaptor.

15. The method of claim 13, further comprising the step of selecting a one-piece vial adaptor.

16. A needle-free syringe for use in a needle-free injection system comprising:

a needle-free syringe body that is open on one end and includes an injection orifice at a second end;

a plunger disposed in the open end of the needle-free syringe body for drawing injection fluid into and driving injection fluid out of the needle-free syringe body via the injection orifice; and

a filling cap frangibly mounted to the second end of the needle-free syringe body and having an outwardly-extending recess for receiving an outwardly-extending portion of a vial adapter mounted to an injection-fluid-containing vial.

17. The needle-free syringe of claim 16 wherein a non-smooth surface faces outwardly from the second end of the needle-free syringe body to minimize the likelihood of the needle-free syringe being used more than once.

18. The needle-free syringe of claim 16, further comprising at least one raised member facing outwardly from the second end of the needle-free syringe body to minimize the likelihood of the needle-free syringe being used more than once.

19. The needle-free syringe of claim 16, further comprising a plurality of raised members facing outwardly from the second end of the needle-free syringe body to minimize the likelihood of the needle-free syringe being used more than once.

20. The needle-free syringe of claim 16 wherein the needle-free syringe-engagement portion includes at least one undercut portion facing outwardly from the second end of the needle-free syringe body to minimize the likelihood of the needle-free syringe being used more than once.

21. The needle-free syringe of claim 20 in which the at least one undercut portion comprises a slot.

22. The needle-free syringe of claim 20, further comprising at least one raised member facing outwardly from the second end of the needle-free syringe body to minimize the likelihood of the needle-free syringe being used more than once.

23. The needle-free syringe of claim 16, further comprising means for preventing the needle-free syringe from being refilled.

24. The needle-free syringe of claim 16, further comprising a plurality of raised or undercut portions at the second end of the needle-free syringe.

25. The needle-free syringe of claim 16 wherein the outwardly-extending recess receives the outwardly-extending portion of a vial adaptor in a luer fitting.

26. The needle-free syringe of claim 16 wherein the filling cap is mounted to the needle-free syringe in a luer filling.

27. The needle-free syringe of claim 16 wherein the filling cap includes at least one aperture facing the needle-free syringe which is offset with respect to the injection orifice.

28. The needle-free syringe of claim 16 wherein the filling cap includes a solid surface that faces the injection orifice.

29. A needle-free injection system comprising:

an injector body;

a trigger system disposed on the body for firing the injector;

a needle-free syringe to be positioned within the body, the needle-free syringe including an open end having a plunger positioned for drawing injection fluid into and driving injection fluid out of the needle-free syringe, and having a second end including an injection orifice;

a system for providing power to drive the plunger forward to drive injection fluid out of the injection orifice;

a filling system including a filling cap having one end that is frangibly mounted adjacent the second end of the needle-free syringe, radially outwardly of the injection orifice, the filling cap having another end defining a vial adapter mount for removably mounting the filling cap to a vial adapter that is positioned on a vial having injection fluid therein.

30. The filling cap of claim 29 wherein the second end of the needle-free syringe provides a non-smooth surface facing outwardly from the needle-free syringe to minimize the likelihood of the needle-free syringe being used more than once.

31. The injection system of claim 29 wherein at least one extension is disposed adjacent the second end of the needle-free syringe to minimize the likelihood of the needle-free syringe being re-filled after the frangibly mounted filling cap is broken away from the needle-free syringe.

32. The injection system of claim 29 wherein at least one depression is positioned adjacent the second end of the needle-free syringe to minimize the likelihood of the needle-free syringe being re-filled after the frangibly mounted filling cap is broken away from the needle-free syringe.

33. The injection system of claim 29, further comprising at least one extension disposed adjacent the second end of the needle-free syringe to minimize the likelihood of the needle-free syringe being re-filled after the frangibly mounted filling cap is broken away from the needle-free syringe.

34. The injection system of claim 29 wherein the filling cap is mounted adjacent the second end of the needle-free syringe in a luer fitting.

35. The injection system of claim 29 wherein the filling cap is removably mounted to the vial adapter in a luer fitting.

36. The injection system of claim 29, further comprising a one-piece vial adapter to be mounted to the vial.

37. The injection system of claim 29 wherein the one end of the filling cap includes a solid surface facing the injection orifice.

38. The injection system of claim 29, further comprising means for preventing re-use of the needle-free syringe.

39. The injection system of claim 29, further comprising a plurality of extensions and/or depressions defined in the second end of the needle-free syringe.

42. A device for filling a needle-free syringe, comprising:

a vial-engagement portion and a needle-free syringe-engagement portion, with a frangible portion extending therebetween, the vial-engagement portion designed to engage a vial of fluid to be filled into the needle-free syringe, the needle-free syringe-engagement portion designed to nonremovably engage an needle-free syringe.

43. The device of claim 42, further comprising means for preventing the needle-free syringe from being filled more than once.

44. The device of claim 43, wherein the means for preventing the needle-free syringe from being filled more than once comprises a plurality of extensions or depressions facing outwardly from the needle-free syringe that prevent the needle-free syringe from being used more than once.

45. The device of claim 43, wherein the means for preventing the needle-free syringe from being filled more than once comprises a non-smooth surface in the needle-free syringe-engagement portion, facing outwardly from the needle-free syringe.

46. The device of claim 43, wherein the means for preventing the needle-free syringe from being filled more than once comprises at least one raised member in the needle-free syringe-engagement portion, facing outwardly from the needle-free syringe.

47. The device of claim 46, further comprising a plurality of raised members facing outwardly from the needle-free syringe engagement portion.

48. The device of claim 43, wherein the means for preventing the needle-free syringe from being filled more than once comprises at least one undercut portion in the needle-free syringe engagement portion, facing outwardly from the needle-free syringe.

49. The device of claim 48, in which the undercut portion comprises at least one slot.

50. The device of claim 48, wherein the means for preventing the needle-free syringe from being filled more than once further comprises at least one raised member facing outwardly from the needle-free syringe.

51. The device of claim 42, further comprising means for preventing engagement of the device with the needle-free syringe after the frangible portion has been broken.

52. The device of claim 42, wherein the device is without a system for forming the device back into a single, fluid-tight unit after the frangible portion has been broken.

53. The device of claim 42, wherein the device is fabricated of rigid plastic material.

54. The device of claim 42, wherein the device is fabricated of a rigid material so that if the vial onto which the vial-engagement portion is mounted is tilted with respect to the needle-free syringe onto which the needle-free syringe-engagement portion is mounted, the device will break at the frangible portion.

55. A method for filling a needle-free syringe, comprising:

selecting a needle-free syringe having an injection orifice and a fluid chamber with a plunger therein;

providing a device having a fluid channel, a vial-engagement portion and a needle-free syringe-engagement portion, with a frangible portion extending between the vial-engagement and needle-free syringe-engagement portions;

engaging the device with a vial having fluid therein to be passed into the syringe;

non-removably engaging the device with the syringe;

retracting the plunger to draw fluid into the syringe; and

breaking the device at the frangible portion while retaining the vial-engagement portion on the vial.

56. The method of claim 55, wherein the step of retracting the plunger to draw fluid into the syringe causes fluid to pass from the vial, through the channel, through the orifice, and into the fluid chamber.

57. The method of claim 56, wherein the step of retracting the plunger causes fluid to pass from the vial, through the channel, through a plurality of spaced apertures disposed radially outwardly of the orifice, and then through the orifice and into the fluid chamber.

58. The method of claim 55, wherein the step of breaking the device at the frangible portion comprises breaking the device such that it cannot be re-attached into a fluid-tight connection.

59. The method of claim 55, wherein the step of providing a device comprises providing a rigid device, and wherein the step of breaking the device at the frangible portion comprises tilting the vial with respect to the syringe until the device breaks at the frangible portion.

60. A needle-free syringe structure comprising:

a syringe portion adjacent one end, the syringe portion including a fluid chamber for receiving injection fluid and holding it for injection, an injection orifice for permitting injection fluid to be injected therethrough from the fluid chamber during injection, and a plunger for drawing injection fluid into and forcing fluid out of the fluid chamber via the injection orifice;

a vial-engagement portion adjacent an opposite end of the syringe structure for engaging the mouth of a vial containing injection fluid; and

a frangible connection between the syringe portion and the vial-engagement portion, the frangible connection being adapted to be broken after the chamber has been filled with injection fluid to prepare the syringe structure for injection.

61. The syringe structure of claim 60, wherein the frangible connection comprises a rigid plastic structure disposed radially outward of the orifice.

62. The syringe structure of claim 60, wherein the frangible connection further comprises structure that prevents a fluid-tight seal to be formed at the frangible connection after the connection has been broken.

63. The syringe structure of claim 60, wherein the syringe structure is rigid so that the frangible connection breaks when the vial-engagement portion is tilted with respect to the syringe portion.