Apparatus for delivering a substance having one or more needles driven at high velocity

• US 6,890,319 B1
• Filed: 08/13/1999
• Issued: 05/10/2005
• Est. Priority Date: 08/13/1998
• Status: Expired due to Fees

• Current Assignee: Imprint Pharmaceuticals Limited
• Original Assignee: Imprint Pharmaceuticals Limited
• Inventors: Crocker, Peter John
• Primary Examiner(s): Derakshani, Philippe
• Application Number:
  US09/762,887
• Time in Patent Office: 2,097 Days
• Field of Search: 604/156, 604/131
• US Class Current: 604/131
• CPC Class Codes: A01K 11/005 Branding or tattooing devices for animals
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 37/0076 Tattooing apparatus apparatus for marking animals A01K11/00; vaccine applicators having needles or other puncturing means A61B17/205
• 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 5/31531 Microsyringes, e.g. having piston bore diameter close or equal to needle shaft diameter
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61M 5/422 Desensitising skin
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

An apparatus for delivering a substance to a surface, such as the skin of a human being, animal or other organic matter has a needle. Also provided is means for supplying the substance to the tip of the needle in use, and driving means for driving the needle, in use, at a velocity in the range of 1 meter per second to 100 meters per second in order to penetrate the surface and deliver the substance thereto.

Claims

1. Apparatus for injecting a substance into a surface, such as the skin of a human being, animal or other organic matter, the apparatus comprising:

(a) at least one needle;

(b) means for supplying the substance to the tip of the needle;

(c) a driving means for driving the needle at a velocity in the range of 1 meter per second to 100 meters per second in which in use the majority of the energy for penetration comes from the momentum of the needle and associated moving parts and not from the continued force of the driving means.

2. Apparatus as claimed in claim 1 in which the driving means drives the needle at 5 to 50 meters per second.

3. Apparatus as claimed in claim 1 in which the driving means drives the needle at 6 to 35 meters per second.

4. Apparatus as claimed in claim 1 in which the driving means is pneumatically operated.

5. An apparatus as claimed in claim 1 in which there is a stopping means incorporated in the driving means adapted to bring the needle to a rapid stop at a predetermined depth of penetration.

6. An apparatus as claimed in claim 4 in which there is a stopping means incorporated in the driving means adapted to bring the needle to a rapid stop at a predetermined depth of penetration.

7. Apparatus as claimed in claim 1 in which there is a withdrawal means adapted to withdraw the needle from the surface.

8. Apparatus as claimed in claim 7 in which the driving means incorporates a means to drive the needle into the surface in a plurality of stages.

9. Apparatus as maimed in claim 1 in which the diameter of the one or more needles is in the range of 10 to 1000 microns and are arranged so that they form from 1 to 5000 holes per square centimeter.

10. An apparatus as claimed in claim 1 in which, in use the majority of the energy for penetration comes from the momentum of the needle and associated moving parts and not from the continued force of the driving means.

11. An apparatus as claimed in claim 5 in which, in use the majority of the energy for penetration comes from the momentum of the needle and associated moving parts and not from the continued force of the driving means.

12. Apparatus as claimed in claim 1 in which there is an end piece which forms part of, or is connected to the end of the needle which end piece is positioned at one end of a conduit, the said driving means comprising a block slidably mounted in the conduit and a pneumatic means adapted to apply a pneumatic force at one end of the conduit to propel the block down the conduit, so that the block strikes the said end piece.

13. Apparatus as claimed in claim 5 in which there is an end piece which forms part of, or is connected to the end of the needle which end piece is positioned at one end of a conduit, the said driving means comprising a block slidably mounted in the conduit and a pneumatic means adapted to apply a pneumatic force at one end of the conduit to propel the block down the conduit, so that the block strikes the said end piece.

14. Apparatus as claimed in claim 12 in which there are means to generate a pulse of air in the conduit which propels the block down the conduit.

15. Apparatus as claimed in claim 14 in which there are block withdrawal means to return the block to its original position by reduction of pressure in the conduit.

16. Apparatus as claimed in claim 13 in which the driving means applies a plurality of pulsed impulses to the block and the is a block withdrawal means to withdraw the block back down the conduit between pulses to its original position by reduction of pressure in the conduit.

17. Apparatus as claimed in claim 12 in which there are two or more blocks mounted within the conduit so that, in use, a plurality of blows impact on the end piece.

18. Apparatus as claimed in claim 1 in which the needle is separate and adjacent to a syringe containing the substance to be injected with one and of the needle fluidically and flexibly, connected to the end of the syringe and there being sufficient flexibility in this connection so that rapid acceleration and movement of the needle is not significantly inhibited by its connection to the syringe.

19. Apparatus as claimed in claim 12 in which the needle is separate and adjacent to a syringe containing the substance to be injected with one end of the needle fluidically and flexibly connected to the and of the syringe and there being sufficient flexibility in this connection so that rapid acceleration and movement of the needle is not significantly inhibited by its connection to the syringe.

20. Apparatus as claimed in claim 18 in which the needle is coiled, looped or zig-zagged.

21. Apparatus as claimed in claim 1 in which there is a syringe which has a piston mounted therein with the said needle projecting through the end of the syringe and the other end of the needle having an extension projecting through the piston so the end of the extension can be struck by the driving means to drive the needle into the surface, there being a connection means between and the needle and the syringe whereby a substance in the syringe passes through the needle from the syringe as the piston is depressed.

22. Apparatus as claimed in claim 12 in which there is a syringe which has a piston mounted therein with the said needle projecting through the end of the syringe and the other end of the needle having an extension projecting through the piston so the end of the extension can be struck by said block to drive the needle into the surface, there being a connection means between the needle and the syringe whereby a substance in the syringe passes through the needle from the syringe as the piston is depressed.

23. Apparatus as claimed in claim 1 in which part of the momentum of the said block is transferred to the syringe to induce pressure which injects a quantity of the substance to be injected into the skin.

24. Apparatus as claimed in claim 1 in which the mass of the needle and associated moving parts is from 0.01 to 2.5 grams.

25. Apparatus as claimed in claim 23 in which the mass of the needle and associated moving parts is from 0.01 to 2.5 grams.

26. Apparatus as claimed in claim 1 in which there is a needle guide through which the needle can slide in use to restrict transaxial or lateral movement of the needle.

27. An apparatus as claimed in claim 26 in which the needle guide restricts the transaxial or lateral movement of the needle to below +/−

2 degrees.

28. Apparatus as claimed in claim 1 in which the needle is hollow with at least one aperture connecting to core directly adjacent to the tip to allow injections to be made at a depth of less than 1 mm below the skin surface.

29. An apparatus as claimed in claim 1 in which the needle has substantially non-cutting tip with substantially no sharpened edges or blades with smooth, tapered, radiused or beveled edges or surfaces.

30. Apparatus as claimed in claim 29 in which the needle is conical or with a radiused point and one or more slots are present which connect the core to the exterior to allow, in use, delivery of the substance below skin surface and in which when the needle is entering the skin the one or more slots are substantially closed to prevent entry of external material or tissue into the core.

31. Apparatus as claimed in claim 30 in which when fluidic pressure is applied from the care to the exterior the dimensions of the one or more slots increases to allow greater flow of fluidic substance.

32. Apparatus as claimed in claim 30 in which the one or more slots are linear and parallel to the needle axis, inclined at an angle to the axis, spiral in form or are arranged to define a moveable flap which closes like a valve when external pressure is applied to the needle and opens like a valve when internal pressure is applied.

33. An apparatus as claimed in claim 1 in which the needle has a blunt tip.

34. Apparatus as claimed in claim 12 in which there are means to generate is pulse of air in the conduit which propels the block down the conduit.

35. Apparatus as claimed in claim 14 in which there are block withdrawal means to return the block to its original position by redaction of pressure in the conduit.

36. Apparatus as claimed in claim 13 in which the driving means applies a plurality of pulsed impulses to the block and there is a block withdrawal means to withdraw the block back down the conduit between pulses to its original position by reduction of pressure in the conduit.

37. Apparatus as claimed in claim 12 in which there are two or more blocks mounted within the conduit so that, in use, a plurality of blows impact on the end piece.

38. Apparatus as claimed in claim 1 in which the needle is separate and adjacent to a syringe containing the substance to be injected with one end of the needle fluidically and flexibly connected to the end of the syringe and there being sufficient flexibility in this connection so that rapid acceleration and movement of the needle is not significantly inhibited by its connection to the syringe.

39. Apparatus as claimed in claim 12 in which the needle is separate and adjacent to a syringe containing the substance to be injected with one end of the needle fluidically and flexibly connected to the end of the syringe and there being sufficient flexibility in this connection so that rapid acceleration and movement of the needle is not significantly inhibited by its connection to the syringe.

40. Apparatus as claimed in claim 18 in which the needle is coiled, looped or zig-zagged.

41. Apparatus as claimed in claim 1 in which there is a syringe which has a piston mounted therein with the said needle projecting through the end of the syringe and the other end of the needle having an extension projecting through the piston so the end of the extension can be struck by the driving means to drive the needle into the surface, there being a connection means between and the needle and the syringe whereby a substance in the syringe passes through the needle from the syringe as the piston is depressed.

42. Apparatus as claimed in claim 12 in which there is a syringe which has a piston mounted therein with the said needle projecting through the end of the syringe and the other end of the needle having an extension projecting through the piston so the end of the extension can be struck by said block to drive the needle into the surface, there being a connection means between and the needle and the syringe whereby a substance in the syringe passes through the needle from the syringe as the piston is depressed.

43. Apparatus as claimed in claim 23 in which part of the momentum of the said block is transferred to the syringe to induce pressure which injects a quantity of the substance to be injected into the skin.

44. Apparatus as claimed in claim 1 in which the mass of the needle and associated moving parts is from 0.01 to 2.5 grams.

45. Apparatus as claimed in claim 1 in which the mass of the needles and associated moving parts is from 0.01 to 2.5 grams.

46. Apparatus as claimed in claim 1 in which there is a needle guide through which the needle can slide in use to restrict transaxial or lateral movement of the needle.

47. Apparatus as claimed in claim 26 in which the needle guide restricts the transaxial or lateral movement of the needle to below +/−

2 degrees.

48. Apparatus as claimed in claim 1 in which the needle is hollow with at least one aperture connecting to core directly adjacent to the tip to allow injections to be made are a depth of less than 1 mm below the skin surface.

49. An apparatus as claimed in claim 1 in which the needle has substantially non-cutting tip with substantially no sharpened edges or blades with smooth, tapered, radiused or beveled edge or surfaces.

50. Apparatus as claimed in claim 30 in which the needle is conical or with a radiused point end and one or more slots are present which connect the core to the exterior to allow, in use, delivery of the substance below skin surface and in which when the needle is entering the skin the one or more slots are substantially closed to prevent entry of external material or tissue into the core.

51. Apparatus as claimed in claim 30 in which when fluidic pressure is applied from the core to the exterior the dimensions of the one or more slots increases to allow greater flow of fluidic substance.

52. Apparatus as claimed in claim 30 in which the one or more slots are linear and parallel to the needle axis, inclined at an angle to the axis, spiral in form or are arranged to define a moveable flap which closes like a valve when external pressure is applied to the needle and opens like a valve when internal pressure is applied.

53. Apparatus for injecting a substance into a surface, such as the skin of a human being, animal or other organ matter, the apparatus comprising:

(d) at least one needle;

(e) means for supplying the substance to the tip of the needle a driving means for driving the needle at a velocity in the range of 5 meters per second to 100 meters per second in which the driving means is adapted to deliver an impact to the needle to drive the needle.

54. An apparatus as claimed in claim 53 in which the driving means is adapted to accelerate the needle to an acceleration between 1 to 20,000 g.

55. An apparatus as claimed in claim 53 in which the needle has a blunt tip.

56. Apparatus as claimed in claim 53 in which the driving means drives the needle at 5 to 50 meters per second.

57. Apparatus as claimed in claim 53 in which the driving means drives the needle at 6 to 35 meters per second.

58. Apparatus as claimed in claim 54 in which the driving means is pneumatically operated.

59. An apparatus as claimed in claim 55 in which there is stopping means incorporated in the driving means adapted to bring the needle to a rapid stop at a predetermined depth of penetration.

60. An apparatus as claimed in claim 53 in which there is stopping means incorporated in the driving means adapted to bring the needle to a rapid stop at a predetermined depth of penetration.

61. Apparatus as claimed as claim 53 in which there is a withdrawal means adapted to withdraw the needle from the surface.

62. Apparatus as claimed in claim 53 in which the driving means incorporates a means to drive the needle into the surface in a plurality of stages.

63. Apparatus as claimed in claim 53 in which the diameter of the one or more needles is in the range of 10 to 1000 microns and are arranged so that they form from 1 to 5000 holes per square centimeter.

64. An apparatus as claimed in claim 53 in which, in use the majority of the energy for penetration comes from the momentum of the needle and associated moving parts and not from the continued force of the driving means.

65. Apparatus as claimed in claim 53 in which there is an end piece which forms part of, or is connected to the end of the needle which end piece is positioned at one end of a conduit, the said driving means comprising a block slidably mounted in the conduit and a pneumatic means adapted to apply a pneumatic force at one end of the conduit to propel the block down the conduit, so that the block strikes the said end piece.

66. Apparatus as claimed in claim 53 in which there are means to generate a pulse of air in the conduit which propels the block down the conduit.

67. Apparatus as claimed in claim 53 in which there are one or more slots extending linear and parallel to the needle axis, inclined at an angle to the axis, spiral in form or are arranged to define a moveable flap which closes like a valve when external pressure is applied to the needle and opens like a valve when internal pressure is applied.

68. A method for injecting a substance into a surface which method comprises using an injector which consists of at least one needle and a means for supplying the substance to the tip of the needle in which method the needle is placed against the surface and the end of the needle struck by an impact to drive the needle into the surface at a velocity in the range of 1 to 100 meters per second and the substance supplied to the tip of the needle to inject the substance into the surface.