CA2460063A1 - Microneedle-based pen device for drug delivery and method for using same - Google Patents

Microneedle-based pen device for drug delivery and method for using same Download PDF

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Publication number
CA2460063A1
CA2460063A1 CA002460063A CA2460063A CA2460063A1 CA 2460063 A1 CA2460063 A1 CA 2460063A1 CA 002460063 A CA002460063 A CA 002460063A CA 2460063 A CA2460063 A CA 2460063A CA 2460063 A1 CA2460063 A1 CA 2460063A1
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CA
Canada
Prior art keywords
microneedle
delivery device
substance
contact surface
intradermal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002460063A
Other languages
French (fr)
Other versions
CA2460063C (en
Inventor
Ronald Pettis
Frank Martin
Scott Kaestner
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Becton Dickinson and Co
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Individual
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Filing date
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Publication of CA2460063A1 publication Critical patent/CA2460063A1/en
Application granted granted Critical
Publication of CA2460063C publication Critical patent/CA2460063C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/288—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened by piercing without internal pressure increase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • A61M5/3298—Needles arranged in parallel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/31568—Means keeping track of the total dose administered, e.g. since the cartridge was inserted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Abstract

A system and method is provided for an injectable substance delivery pen (80 ) comprising a microneedle hub assembly (44) removably engaged with a pen devi ce body (66) which includes a cartridge (68), a plunger (72), and a drive mechanism (73). The hub assembly (44) includes at least one microneedle (50) for intradermal or shallow subcutaneous injection of the contents of the cartridge (68). The cartridge, plunger and drive mechanism components of the pen body are fabricated of non-compliant and non-compressible materials to allow effective communication of the cartridge contents via the microneedle patient interface.

Claims (72)

1. A microneedle delivery device, comprising:
a hub housing, having a proximate end and a distal end with a skin contact surface, said proximate end having a coupling member for removably coupling said device to a supply reservoir containing a substance to be delivered to a patient;
a piercing member located at said proximate end of said housing and having a length sufficient to pierce said supply reservoir and communicate said substance to a microneedle; and said microneedle attached to and extending from said skin contact surface and having a length sufficient to penetrate the skin of a patient to a selected depth fur communicating said substance to said selected depth.
2. A microneedle delivery device as claimed in claim 1, further comprising a depth limiting member extending from said skin contact surface for limiting a depth of penetration of said microneedle into said skin.
3. A microneedle delivery device as claimed in claim 2, wherein said depth limiting member comprises a post having an axial dimension and an outer face, and wherein said microneedle extends axially from said outer face.
4. A microneedle delivery device as claimed in claim 2, wherein said depth limiting post has a height above said patient contact surface and a width sufficient to allow substantially complete penetration of said microneedle.
5. A microneedle delivery device as claimed in claim 1, wherein said skin contact surface further comprises at least one tensioning member for tensioning said skin during insertion of said microneedle into said skin.
6. A microneedle delivery device as claimed in claim 5, wherein said tensioning member comprises a ridge extending from said skin contact surface and concentrically located about said microneedle.
7. A microneedle delivery device as claimed in claim 5, wherein said tensioning member extends from said contact surface a height of less than or equal to said height of said depth limiting post.
8. A microneedle delivery device as claimed in claim 1, wherein said device is further adapted to allow delivery of said substance of said supply reservoir from said supply reservoir to said selected depth at a rate substantially equivalent to delivery via a single 31 gauge needle.
9. A microneedle delivery device as claimed in claim 1, wherein said distal end includes an engagement opening defining said coupling member.
10. A microneedle delivery device as claimed in claim 1, wherein said coupling member is selected from the group consisting of a threaded fitting, a luer fitting and a snap fit fitting.
11. A microneedle delivery device as claimed in claim 1, wherein said skin contact surface is formed at an angle of 90 degrees or less relative to a center line of said hub housing.
12. A microneedle delivery device as claimed in claim 1, wherein said piercing member is made from a material selected from the group consisting of stainless steel, silicon, silicon compound and plastic.
13. A microneedle delivery device as claimed in claim 1, wherein said piercing member comprises a needle.
14. A microneedle delivery device as claimed in claim 1, wherein said piercing member comprises a 31 gauge needle.
15. A microneedle delivery device as claimed in claim 1, wherein said microneedle is made from a material selected from the group consisting of stainless steel, silicon, silicon compound and plastic.
16. A microneedle delivery device as claimed in claim 1, wherein said microneedle comprises a microneedle of at least 30 gauge.
17. A microneedle delivery device as claimed in claim 1, wherein said microneedle comprises a microneedle of at least 31 gauge.
18. A microneedle delivery device as claimed in claim 1, wherein said microneedle comprises a microneedle of at least 34 gauge.
19. A microneedle delivery device as claimed in claim 1, wherein said microneedle includes a first and second end, said first end having a smaller gauge than said second end, said second end comprising said piercing member.
20. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length of between about 0.3 mm and about 5.0 mm.
21. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length of between about 0.3 mm and about 2.0 mm to access intradermal tissue space.
22. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length of between about 0.75 mm and about 1.70 mm to access intradermal tissue space.
23. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length of between about 2.0 mm and about 5.0 mm to access shallow subcutaneous tissue space.
24. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length of between about 1.7 mm and about 5.0 mm to access shallow subcutaneous tissue space.
25. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length of between about 1.7 mm and about 3.0 mm to access shallow subcutaneous tissue space.
26. A microneedle delivery device as claimed in claim 1, wherein said device comprises a plurality of said microneedles extending from said skin contact surface.
27. A microneedle delivery device as claimed in claim 1, wherein said device comprises a plurality of said depth limiting members extending from said skin contact surface.
28. A microneedle delivery device as claimed in claim 1, wherein said device comprises a plurality of said skin tensioning members extending from said skin contact surface.
29. A substance delivery device, comprising:
a supply housing having an outlet;
a cartridge in said supply housing containing a substance and having a septum at a first end and a stopper at a second end to seal said cartridge, said stopper being positioned to engage a plunger;
a hub housing having a proximate end and a distal end, said distal end having a skin contact surface and at least one microneedle extending from said skin contact surface, said proximate end removably coupled to said outlet of said supply housing and having a piercing member oriented to pierce said septum, said at least one microneedle having a length suitable for intradermal or shallow subcutaneous delivery of said substance, said microneedle being in fluid communication with said piercing member for receiving said substance from said cartridge; and a drive mechanism located within said supply housing for moving said plunger and said stopper toward said septum to dispense said substance from said cartridge through said piercing member to said at least one microneedle for delivering said substance to a patient.
30. A substance delivery device as claimed in claim 29, wherein said patient contact surface further comprises a depth limiting post to support and limit a depth of insertion for said microneedle, said post formed about said microneedle and extending above said patient contact surface.
31. A substance delivery device as claimed in claim 30, wherein said depth limiting post includes an axial dimension and an outer face, and wherein said microneedle extends axially from said outer face.
32. A microneedle delivery device as claimed in claim 30, wherein said depth limiting post has a height above said patient contact surface and a width sufficient to allow substantially complete penetration of said microneedle.
33. A substance delivery device as claimed in claim 29, wherein said patient contact surface further comprises a tensioning ring to tension patient skin during insertion of said microneedle, said ring comprising a ridge raised from said patient contact surface and concentrically located about said microneedle.
34. A substance delivery device as claimed in claim 33, wherein said tensioning ring extends from said contact surface a height of less than or equal to said height of said depth limiting post.
35. A substance delivery device as claimed in claim 29, wherein said engagement opening comprises a mechanical coupling mechanism to securely engage said pen body housing, said engagement bringing said piercing member into contact with said contents of said medication cartridge and allowing communication of said contents to said microneedle via said fluid delivery channel.
36. A substance delivery device as claimed in claim 35, wherein said mechanical coupling is selected from the group consisting of a threaded fitting, a luer fitting and a snap fit fitting.
37. A substance delivery device as claimed in claim 29, wherein said device is further adapted to allow delivery of said contents from said cartridge to said patient at a rate substantially equivalent to delivery via a single 31 gauge needle.
38. A substance delivery device as claimed in claim 29, wherein said patient contact surface is formed at an angle of 90 degrees or less relative to a center line of said medication delivery pen.
39. A substance delivery device as claimed in claim 29, wherein said piercing member is made from a material selected from the group consisting of stainless steel, silicon, silicon compound and plastic.
40. A substance delivery device as claimed in claim 29, wherein said piercing member comprises a needle.
41. A substance delivery device as claimed in claim 29, wherein said piercing member comprises a 31 gauge needle.
42. A substance delivery device as claimed in claim 29, wherein said microneedle is made from a material selected from the group consisting of stainless steel, silicon, silicon compound and plastic.
43. A substance delivery device as claimed in claim 29, wherein said microneedle comprises a microneedle of at least 30 gauge.
44. A substance delivery device as claimed in claim 29, wherein said microneedle comprises a microneedle of at least 31 gauge.
45. A substance delivery device as claimed in claim 29, wherein said microneedle comprises a microneedle of at least 34 gauge.
46. A substance delivery device as claimed in claim 29, wherein said microneedle includes a first and second end, said first end having a smaller gauge than said second end and said second end comprising said piercing member.
47. A substance delivery device as claimed in claim 29, wherein said microneedle has an exposed length of between about 0.3 mm and about 5.0 mm.
48. A substance delivery device as claimed in claim 29, wherein said microneedle has an exposed length of between about 0.3 mm and about 2.0 mm to access intradermal tissue space.
49. A substance delivery device as claimed in claim 29, wherein said microneedle has an exposed length of between about 0.75 mm and about 1.70 mm to access intradermal tissue space.
50. A substance delivery device as claimed in claim 29, wherein said microneedle has an exposed length of between about 2.0 mm and about 5.0 mm to access shallow subcutaneous tissue space.
51. A substance delivery device as claimed in claim 29, wherein said microneedle has an exposed length of between about 1.7 mm and about 5.0 mm to access shallow subcutaneous tissue space.
52. A substance delivery device as claimed in claim 29, wherein said microneedle has an exposed length of between about 1.7 mm and about 3.0 mm to access shallow subcutaneous tissue space.
53. A substance delivery device as claimed in claim 29, wherein said stopper is made from a material which is substantially non-compressible in use delivering said substance to a patient.
54. A substance delivery device as claimed in claim 29, wherein said plunger is made from a material which is substantially non-compressible in use delivering said substance to a patient.
55. A substance delivery device as claimed in claim 29, wherein said septum is made from a material which is substantially non-compressible in use delivering said substance to a patient.
56. A substance delivery device as claimed in claim 29, wherein said cartridge is made from a material which is substantially non-compressible in use delivering said substance to a patient.
57. A substance delivery device as claimed in claim 29, wherein said device comprises a plurality of said microneedles extending from said skin contact surface.
58. A substance delivery device as claimed in claim 30, wherein said device comprises a plurality of said depth limiting posts extending from said skin contact surface.
59. A substance delivery device as claimed in claim 33, wherein said device comprises a plurality of said tensioning rings extending from said skin contact surface.
60. A method for intradermal delivery of a substance, comprising:
engaging a hub assembly, having a patient contact surface with a tensioning member, a depth limiting member, a piercing member and a microneedle of a length suitable for intradermal or shallow subcutaneous penetration, with a pen body housing containing a cartridge, a plunger and a drive mechanism;
piercing a septum of said cartridge in said pen body housing, said cartridge having said septum at a first end and a stopper at a second end to seal contents within said cartridge, said piercing member engaging said contents of said cartridge;
controlling said pen body housing to insert said microneedle at an insertion site on a patient while maintaining said pen body at an angle of 90 degrees or less relative to the plane of said insertion site surface such that said patient contact surface is parallel to said insertion site surface and applying tension to said insertion site via said tensioning member; and controlling said drive mechanism located within said pen body housing to engage said plunger and said stopper causing said contents to flow from said cartridge through said hub assembly and into said insertion site.
61. A method for intradermal delivery of a substance as claimed in claim 60, wherein said applied tension is created by said tensioning member comprising a ridge raised from said patient contact surface and concentrically located about said microneedle and adapted to tension said injection site during insertion of said microneedle.
62. A method for intradermal delivery of a substance as claimed in claim 60, wherein said applied tension is created by said depth limiting member comprising a depth limiting post formed about said microneedle and extending above said patient contact surface, said post having an axial dimension and an outer face wherein said microneedle extends axially from said outer face
63. A method for intradermal delivery of a substance as claimed in claim 60, wherein said patient contact surface is formed at an angle of 90 degrees or less relative to a center line of said hub assembly.
64. A method for intradermal delivery of a substance as claimed in claim 60, wherein said microneedle has an exposed length of between about 0.3 mm and about 5.0 mm.
65. A method for intradermal delivery of a substance as claimed in claim 60, wherein said microneedle has an exposed length of between about 0.3 mm and about 2.0 mm to access intradermal tissue space.
66. A method for intradermal delivery of a substance as claimed in claim 60, wherein said microneedle has an exposed length of between about 0.75 mm and about 1.70 mm to access intradermal tissue space.
67. A method for intradermal delivery of a substance as claimed in claim 60, wherein said microneedle has an exposed length of between about 2.0 mm and about 5.0 mm to access shallow subcutaneous tissue space.
68. A method for intradermal delivery of a substance as claimed in claim 60, wherein said microneedle has an exposed length of between about 1.7 mm and about 5.00 mm to access shallow subcutaneous tissue space.
69. A method for intradermal delivery of a substance as claimed in claim 60, wherein said microneedle has an exposed length of between about 1.7 mm and about 3.0 mm to access shallow subcutaneous tissue space.
70. A method for intradermal delivery of a substance as claimed in claim 60, wherein said hub assembly comprises a plurality of said microneedles extending from said patient contact surface.
71. A method for intradermal delivery of a substance as claimed in claim 60, wherein said hub assembly comprises a plurality of said tensioning members raised from said patient contact surface.
72. A method for intradermal delivery of a substance as claimed in claim 60, wherein said hub assembly comprises a plurality of said depth limiting members extending above said patient contact surface.
CA2460063A 2001-09-12 2002-09-11 Microneedle-based pen device for drug delivery and method for using same Expired - Lifetime CA2460063C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US31888601P 2001-09-12 2001-09-12
US31891301P 2001-09-12 2001-09-12
US60/318,913 2001-09-12
US60/318,886 2001-09-12
PCT/US2002/028785 WO2003022330A2 (en) 2001-09-12 2002-09-11 Microneedle-based pen device for drug delivery and method for using same

Publications (2)

Publication Number Publication Date
CA2460063A1 true CA2460063A1 (en) 2003-03-20
CA2460063C CA2460063C (en) 2010-07-20

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CA2460063A Expired - Lifetime CA2460063C (en) 2001-09-12 2002-09-11 Microneedle-based pen device for drug delivery and method for using same

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US (3) US7556615B2 (en)
EP (1) EP1432466B1 (en)
JP (1) JP4383168B2 (en)
CN (1) CN100349629C (en)
AU (1) AU2002333554C1 (en)
BR (1) BRPI0212496B8 (en)
CA (1) CA2460063C (en)
DK (1) DK1432466T3 (en)
ES (1) ES2393282T3 (en)
MX (1) MXPA04002283A (en)
WO (1) WO2003022330A2 (en)
ZA (1) ZA200401969B (en)

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US8900186B2 (en) 2014-12-02
US7556615B2 (en) 2009-07-07

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