Prefillable intradermal injector

• US 6,569,123 B2
• Filed: 04/13/2001
• Issued: 05/27/2003
• Est. Priority Date: 10/14/1999
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Alchas, Paul G., Korisch, Marina S., Guillermo, Carlos E.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/834,669
• Publication Number:
  US 20010056263A1
• Time in Patent Office: 774 Days
• Field of Search: 604/117, 604/187, 604/192, 604/198, 604/110, 604/164, 604/165, 604/162
• US Class Current: 604/192
• 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 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 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• 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 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3278 Apparatus for destroying used needles or syringes needle resheathing means destroying the needle A61M5/321
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A prefillable delivery device for administering intradermal injections includes a prefillable container adapted to store a substance. The substance is expelled through a needle cannula having a forward tip adapted to administer the intradermal injection. A limiter surrounds the needle cannula having a generally flat skin engaging surface extending in a plane generally perpendicular to the needle cannula. An insert is centrally located within the skin engaging surface and is piercable by the forward tip. A sleeve with a first end and a second end surrounds the prefillable container. The limiter is slidably inserted through the first end and the second end is affixed to a depressable plunger for expelling the substance from the container. The limiter is movable between a first position and a second position thereby exposing the forward tip and is selectively movable between a third position and a fourth position thereby concealing the forward tip.

Claims

1. A prefillable intradermal injector for use in intradermally injecting substances into the skin of an animal comprising:

a prefillable reservoir adapted to store a substance and having an outlet port at a first end enabling the substance to be expelled from said reservoir and a stopper in a second open end;

a needle cannula defining an axis and said needle cannula in fluid communication with said reservoir to receive the substance from said outlet port and having a forward tip adapted to penetrate the skin of an animal;

a limiter surrounding said needle cannula, said limiter including a generally flat skin engaging surface extending in a plane generally perpendicular to an axis of said needle cannula, said limiter limiting penetration of said forward tip of said needle cannula into the dermis layer of the skin of the animal; and

a sleeve having a first end and a second end, said sleeve surrounding and slidable relative to said reservoir along said axis and said sleeve fixed relative to said stopper whereby movement of said sleeve causes said stopper to move through said reservoir to expell said substance from said reservoir through said needle cannula.

2. The prefillable intradermal injector as defined in claim 1, wherein said limiter is moveable axially relative to said needle cannula from a retracted position wherein said forward tip of said needle cannula extends through said limiter to an extended position wherein said needle cannula forward tip is enclosed within said limiter.

3. The prefillable intradermal injector as defined in claim 2, wherein said forward tip of said needle cannula extends through said limiter beyond said skin engaging surface no more than from about 0.5 mm to about 3.0 mm in said retracted position of said limiter.

4. The prefillable intradermal injector as defined in claim 1, wherein said limiter is moveable axially relative to said reservoir from a first position wherein said forward tip of said needle is located within said limiter to a second position wherein said needle extends through said limiter beyond said skin engaging surface no more than from about 0.5 to 3.0 mm.

5. A prefillable intradermal injector as set forth in claim 4, wherein said limiter includes an axial opening therethrough receiving said forward tip of said needle cannula and said opening includes pierceable insert sealing said axial opening.

6. The prefillable intradermal injector as set forth in claim 4, wherein said forward tip of said needle cannula extends beyond said skin engaging surface no more than from about 1.0 to 2.0 mm.

7. The prefillable intradermal injector as set forth in claim 4, wherein said forward tip of said needle cannula extending beyond said skin engaging surface about 1.5 mm±

0.2 to 0.3 mm.

8. The prefillable intradermal injector as set forth in claim 5, wherein said forward tip of said needle cannula pierces said insert when said limiter is located in said second position thereby exposing said forward tip enabling administration of the intradermal injection.

9. A prefillable intradermal injector as set forth in claim 2, wherein said limiter includes a locking arm and said sleeve includes a catch engaging said locking arm when said limiter is located in said extended position enclosing said forward tip of said needle cannula.

10. A prefillable intradermal injector as set forth in claim 9, wherein said locking arm includes a hook disposed upon a distal end and said catch includes a slot disposed in said sleeve, said hook engaging said slot when said limiter is located in said extended position.

11. A prefillable intradermal injector as set forth in claim 4, wherein said prefillable container includes a stop to terminate movement of said limiter at said second position when moving said limiter between said first position and said second position.

12. A prefillable intradermal injector as set forth in claim 2, further comprising a spring biasing said limiter to move from said retracted position to said extended position.

13. A prefillable intradermal injector as set forth in claim 12, wherein said spring is coiled around said reservoir.

14. A prefillable intradermal injector as set forth in claim 1, wherein said sleeve includes a stopper engaging portion.

15. A prefillable intradermal injector as set forth in claim 14, wherein said stopper engaging portion includes a plunger rod operably connected to said second end of said sleeve.

16. A method of administering an intradermal injection through a needle cannula from a prefillable intradermal injector having a substance stored in a reservoir in fluid communication with a needle cannula defining an axis, comprising the steps of:

providing a limiter slideably disposed on said reservoir and having a generally flat skin engaging surface extending in a plane generally perpendicular to said axis of said needle cannula having a forward tip located within said limiter;

moving said limiter in a first direction relative to said reservoir to expose said forward tip, wherein said limiter limits penetration of the forward tip of said needle cannula into the dermis layer of the skin;

expelling the substance from said reservoir through said needle cannula into the skin of an animal; and

moving said limiter in a second direction relative to said reservoir to enclose said forward tip inside said limiter.

17. A method as set forth in claim 16, wherein said step of moving said limiter in said first direction includes piercing an insert centrally located within said limiter.

18. A method as set forth in claim 16, further including the step of depressing said skin engaging surface against the skin of the animal thereby inserting the forward tip into the skin of the animal.

19. A method as set forth in claim 16, further including the step of locking said forward tip inside said limiter after administering the intradermal injection.

20. A method as set forth in claim 19, wherein said step of locking said forward tip inside said limiter is further defined by locking said limiter in a position relative to said prefillable container.

21. A method as set forth in claim 16, wherein said penetration of said forward tip of said needle cannula is limited to about 0.5 to 3.0 mm.

22. A method as set forth in claim 16, wherein said penetration of said forward tip of said needle cannula is limited to about 1.0 to 2.0 mm.

23. A method as set forth in claim 16, wherein said penetration of said forward tip of said needle cannula is limited to 1.5 mm±

0.2 to 0.3 mm.

24. A prefillable intradermal injector, comprising:

a reservoir prefillable with a substance having a generally closed proximal end and an open distal end;

a needle cannula having a distal end in fluid communication with said substance in said reservoir extending through said proximal end and an exposed forward tip;

a stopper slideably received in said open distal end of said reservoir moveable in said reservoir to expel said substance through said forward tip of said needle cannula; and

a limiter having a distal end slideably supported around said reservoir and moveable relative to said reservoir and a generally closed proximal end including a flat skin engaging surface having an opening therethrough receiving said forward tip of said needle cannula therethrough as said limiter moves relative to said reservoir and said limiter limiting extension of said forward tip of said needle cannula beyond said skin engaging surface a distance of more than 3.0 mm.

25. The prefillable intradermal injector as set forth in claim 24, wherein said proximal end of said reservoir engages a surface of said limiter as said limiter is moved toward said reservoir, thereby limiting movement of said limiter relative to said reservoir.

26. The prefillable intradermal injector as set forth in claim 24, wherein said intradermal injector includes a sleeve surrounding said reservoir operably fixed to said stopper whereby movement of said sleeve relative to said reservoir moves said stopper through said reservoir.

27. The prefillable intradermal injector as set forth in claim 24, wherein said opening through said proximal end of said limiter includes a pierceable closure and said forward tip of said needle cannula pierces said closure as said limiter is moved toward said reservoir.

28. The prefillable intradermal injector as set forth in claim 24, wherein said forward tip of needle cannula extends through said limiter beyond said skin engaging surface no more than from about 1.0 to 2.0 mm.

29. The prefillable intradermal injector as set forth in claim 28, wherein said forward tip of said needle cannula extends through said limiter 1.5±

0.2 to 0.3 mm.

30. The prefillable intradermal injector as set forth in claim 24, further comprising a spring biased between said reservoir and said limiter moving said limiter to an extended position enclosing said forward tip of said needle cannula following injection.