Intradermal delivery device including a needle assembly

• US 6,494,865 B1
• Filed: 10/14/1999
• Issued: 12/17/2002
• 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.
• Primary Examiner(s): Mendez, Mannel
• Application Number:
  US09/417,671
• Time in Patent Office: 1,160 Days
• Field of Search: 604/46, 604/47, 604/117, 604/192, 604/198, 604/171, 604/197
• 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 2202/0445 Proteins immunoglobulin A61M2202/0417; beta-2-microglobulin A61M2202/0421; thrombin A61M2202/0425; haemoglobin A61M2202/0433
• 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 5/3202 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 5/3278 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 drug delivery device including a needle assembly facilitates making intradermal injections using a variety of drug container types such as a syringe. A hub supports the needle while a limiter surrounds the needle. The limiter includes a skin engaging surface that is adapted to be received against the skin of an animal to be intradermally injected. A forward end of the needle extends beyond the skin engaging surface a selected distance to limit a depth that the needle penetrates into the animal'"'"'s skin.

Claims

1. A hypodermic needle assembly for use in intradermally injecting vaccines into the skin of an animal, comprising:

a hub portion that is able to be attached to a prefillable container for storing a vaccine;

a needle supported by the hub portion, the needle having a hollow body with a forward end extending away from the hub portion; and

a limiter portion that surrounds the needle and extends away from the hub portion toward the forward end of the needle, the limiter portion includes a generally flat skin engaging surface extending through a plane that is generally perpendicular to an axis of the needle and is adapted to be received against the skin of an animal to receive an intradermal injection of a vaccine, the needle forward end extending beyond the skin engaging surface from approximately 0.5 mm to approximately 3 mm such that the limiter portion limits penetration of the needle to the dermis layer of the skin of an animal so that the vaccine is injected into the dermis layer of the animal.

2. The assembly of claim 1, wherein the hub portion and the limiter portion are formed as separate pieces.

3. The assembly of claim 2, wherein the limiter portion includes an inner cavity that receives at least a portion of the hub portion and the inner cavity includes an abutment surface that engages corresponding structure on the hub portion to thereby limit the amount that the needle forward end extends beyond the skin engaging surface.

4. The assembly of claim 2, wherein the limiter portion is integrally formed as part of the prefillable container and the hub portion is received within the limiter portion.

5. The assembly of claim 4, wherein the skin engaging surface surrounds the needle, and has a thickness defined between an inner diameter and an outer diameter and wherein the inner diameter is at least five times greater than an outside diameter of the needle.

6. The assembly of claim 5, wherein the skin engaging surface is generally circular.

7. The assembly of claim 1, wherein the skin engaging surface includes a central opening that is slightly larger than an outside dimension of the needle and the skin engaging surface is continuous.

8. The assembly of claim 1, wherein the skin engaging surface is generally circular.

9. The assembly of claim 1, wherein the forward end of the needle extends beyond the skin engaging surface a fixed distance.

10. The assembly of claim 1, wherein the needle has a diameter no greater than that of a 30 gauge needle.

11. The assembly of claim 1, wherein the skin engaging surface includes a contact surface area that is large enough to stabilize the assembly in a desired orientation relative to the skin.

12. The assembly of claim 1, wherein the prefillable container is a syringe and the animal is human.

13. An intradermal delivery device for use in intradermally injecting vaccines into the skin of an animal, comprising:

a prefillable container having a reservoir adapted to contain a selected vaccine and an outlet port that allows the vaccine to exit the reservoir during an injection;

a needle in fluid communication with the outlet port the needle having a forward end that is adapted to penetrate the skin of an animal; and

a limiter that surrounds the needle and has a generally flat skin engaging surface extending through a plane that is generally perpendicular to an axis of the needle and is adapted to be placed against the skin of the animal to receive an intradermal injection of a vaccine, the needle forward end extending away from the skin engaging surface from approximately 0.5 mm to approximately 3 mm such that the limiter limits penetration of the needle forward end to the dermis layer of the skin of an animal so that the vaccine is injected into the dermis layer of the animal.

14. The device of claim 13, wherein the prefillable container is a syringe including a generally hollow, cylindrical body portion and a plunger that is received within the reservoir, the plunger being selectively movable within the reservoir to cause the vaccine to be forced out of the outlet port during an injection.

15. The device of claim 13, including a hub portion that supports the needle and the hub portion is selectively secured to the prefillable container near the outlet port.

16. The device of claim 13, wherein the needle has a length and wherein the forward end of the needle extends beyond the skin engaging surface a distance that is much less than the needle length.

17. The device of claim 13, wherein the skin engaging surface surrounds the needle, and has a thickness defined between an inner diameter and an outer diameter and wherein the inner diameter is at least five times greater than an outside diameter of the needle.

18. The device of claim 13, wherein the skin engaging surface is generally circular.

19. The device of claim 13, wherein the skin engaging surface includes a central opening that is slightly larger than an outside dimension of the needle and the skin engaging surface is continuous.

20. The device of claim 13, wherein the skin engaging surface includes a contact surface area that is large enough to stabilize the assembly in a desired orientation relative to the skin.

21. The device of claim 13, wherein the prefillable container is prefilled with a vaccine.

22. The device of claim 13, wherein the needle has a diameter no greater than that of a 30 gauge needle.

23. A method of intradermally injecting at least one vaccine into the skin so that the vaccine is only injected into the dermis layer of the skin, comprising the steps of:

pressing a needle having a diameter no greater than that of a 30 gauge needle perpendicularly to the skin of an animal to receive an injection, said needle in fluid communication with an outlet port of a prefillable container having a reservoir adapted to contain a selected vaccine and the outlet port allows the vaccine to exit the reservoir during an intradermal injection of the vaccine;

injecting the vaccine into the dermis layer of the skin of the animal with the depth of penetration of the needle being limited to the intradermal space by a limiter that surrounds the needle and has a generally flat skin engaging surface extending through a plane that is generally perpendicular to an axis of the needle and adapted to be placed against the skin of the animal and a forward end of the needle extending away from the skin engaging surface from approximately 0.5 mm to approximately 3 mm such that the limiter limits penetration of the needle forward end to the dermis layer of the skin of the animal so that the vaccine is injected into the dermis layer of the animal.

24. The method of claim 23, wherein the step of pressing the needle perpendicularly to the skin of the animal includes orienting the needle perpendicularly to the skin.

25. The method of claim 23, wherein the step of injecting the vaccine includes moving a plunger that is received within the reservoir, with the plunger being selectively movable within the reservoir to cause the vaccine to be forced out of the outlet port during the injection.

26. The method of claim 23, further comprising the step of filling the prefillable container with the vaccine to be intradermally injected.

27. The method of claim 23, wherein said prefillable container is a syringe and said animal is human.