Prefillable intradermal delivery device

• US 8,066,680 B2
• Filed: 09/01/2009
• Issued: 11/29/2011
• Est. Priority Date: 10/14/1999
• Status: Expired due to Fees

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Heyman, Peter W., Alchas, Paul G., Laurent, Philippe Emile Fernand, Korisch, Marina S., Guillermo, Carlos E.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US12/551,971
• Publication Number:
  US 20090318888A1
• Time in Patent Office: 819 Days
• Field of Search: 604/110, 604/192, 604/198, 604/171, 604/197, 604/117, 604/187, 604/263
• US Class Current: 604/198
• CPC Class Codes: A61D 7/00 Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals for reproduction or fertilisation A61D19/00 ; devices for implanting pellets, radon seeds or the like A61M37/0069
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2005/3284 Deformaton of needle by deflection or bending
• CPC Class Codes: A61M 2202/0445 Proteins
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/321 Means for protection against accidental injuries by used needles
• CPC Class Codes: A61M 5/3257 Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

An intradermal delivery method for use in intradermally injecting substances into the skin of an animal includes a needle cannula supported by a hub portion that is attachable to a prefillable container. A limiter portion surrounds the needle cannula and extends away from the hub portion toward a forward tip of the needle cannula. The limiter portion includes a skin engaging surface extending in a plane generally perpendicular to an axis of the needle cannula. The skin engaging surface is received against skin of an animal to administer an intradermal injection. The forward tip extends beyond the skin engaging surface a distance that enables penetration of the needle cannula into the dermis layer of the skin of the animal enabling injection of the substance into the dermis layer of the animal. The device includes enclosure means that is moveable for concealing the needle cannula after the injection has been administered.

Claims

1. A method of injecting a medical substance into the skin using a delivery device so that the medical substance is only injected into the dermis layer of the skin, comprising the steps of:

providing said delivery device comprising a prefillable container adapted for storing a medical substance;

pressing a needle cannula attached to said delivery device said needle cannula having a forward tip extending away from said delivery device and a hub portion secured around said needle cannula and a limiter portion surrounding said needle cannula and extending away from said hub portion toward said forward tip of said needle cannula, said limiter portion, said forward tip extending a pre-selected fixed distance beyond a skin engaging surface of approximately 0.5 mm to approximately 3 mm,

engaging the surface of the skin with the skin engaging surface extending in a plane generally perpendicular to an axis of said needle cannula wherein said limiter portion limits penetration of said needle cannula into the dermis layer of the skin of the animal thereby injecting substance into the dermis layer of the animal;

wherein said hub portion defines a locator for said limiter thereby positioning said limiter upon said device; and

deploying an enclosure for concealing said needle cannula after administering said intradermal injection, wherein said enclosure does not comprise any portion of said limiter.

2. A method as set forth in claim 1 wherein said enclosure, which is slidably disposed upon said hub having at least a first position and a second position, said first position exposing said forward tip of said needle cannula and said second position concealing said forward tip of said needle cannula.

3. A method as set forth in claim 2 wherein said enclosure includes at least one slot oriented generally parallel to said needle cannula and having a protuberance disposed on one side thereof.

4. A method as set forth in claim 3 wherein said hub includes at least one locking finger and at least one stop, said at least one locking finger cantilevered away from said forward tip and said at least one stop being cantilevered toward said forward tip.

5. A method as set forth in claim 4 wherein said at least one locking finger includes a tab received by said slot in said enclosure.

6. A method as set forth in claim 5 wherein said tab is snappable over said protuberance for moving said enclosure from said first position to said second position.

7. A method as set forth in claim 6 wherein said protuberance is disposed between said tab and said at least one stop when said enclosure is located in said first position.

8. A method as set forth in claim 7 further comprising the step of engaging a catch which engages said at least one stop when said enclosure is in said second position thereby preventing said enclosure from being moved into said first position from said second position.

9. A method as set forth in claim 2 further comprising attaching said hub portion to an outlet port of said prefillable container.

10. A method as set forth in claim 2 further including removing a cap positioned adjacent said skin engaging surface thereby exposing said forward tip of said needle cannula wherein said cap has an outside dimension equal to or less than said limiter.

11. A method as set forth in claim 10 wherein said cap comprises an elastomeric material.

12. A method as set forth in claim 10 wherein said forward tip of said needle cannula penetrates said cap when said cap is attached to said delivery device thereby sealing said needle cannula.

13. A method of injecting a medical substance into the skin using a delivery device so that the medical substance is only injected into the dermis layer of the skin, comprising the steps of:

providing a prefillable container having a reservoir adapted to contain a selected substance and an outlet port that allows the substance to be expelled from said reservoir during an injection with a needle cannula in fluid communication with said outlet port and having a forward tip adapted to penetrate the skin of an animal;

placing against the skin a limiter surrounding said needle and having a generally flat skin engaging surface extending in a plane generally perpendicular to an axis of said needle cannula;

administering an intradermal injection of the substance, said needle forward tip extending away from the said skin engaging surface a pre-selected, fixed distance from approximately 0.5 mm to approximately 3 mm such that said limiter limits penetration of said forward tip into the dermis layer of the skin of the animal thereby injecting the substance into the dermis layer of the animal; and

deploying an enclosure moveable to conceal said needle cannula.

14. The method as set forth in claim 13 wherein said prefillable container comprises a syringe having a generally hollow, cylindrical body portion and a plunger received within said reservoir, further comprising:

moving said plunger within said reservoir thereby causing the substance to be forced out of said outlet port while administering an intradermal injection.

15. The method as set forth in claim 14 including securing a hub portion supporting said needle cannula to said prefillable container near said outlet port.

16. The method as set forth in claim 13 further comprising depressing a needle bending plunger, wherein said needle bending plunger is inserted radially through said limiter thereby bending said needle cannula thereby retracting said needle cannula into said limiter.

17. The method as set forth in claim 16 wherein said needle bending plunger is oriented generally perpendicular to said needle cannula.

18. The method as set forth in claim 13 further comprising removing a removable cap positioned adjacent said skin engaging surface thereby concealing said forward tip of said needle cannula having an outside dimension equal to or less than said limiter.

19. The method as set forth in claim 18 wherein said cap comprises an elastomeric material.

20. The method as set forth in claim 19 wherein said forward tip of said needle cannula penetrates said cap thereby sealing said needle cannula and preventing the substance from leaking from said reservoir.