Intradermal delivery device including a needle assembly

• US 9,750,897 B2
• Filed: 12/19/2014
• Issued: 09/05/2017
• Est. Priority Date: 10/14/1999
• Status: Expired due to Fees

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Alchas, Paul G.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US14/576,347
• Publication Number:
  US 20150231338A1
• Time in Patent Office: 991 Days
• Field of Search: 604117, 604192, 604 82- 92, 604187, 604199, 604235, 604200, 604198, 604171, 604197
• 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. An intradermal delivery device for use in making intradermal injections, comprising:

a drug container formed of two sheets of thermoplastic material including a body portion that is generally flat and surrounds a reservoir adapted to contain a selected substance and an outlet port that allows the substance to exit the reservoir during an injection;

a needle having a fixed length, wherein said fixed length is selected to be suitable for handling during manufacture of said intradermal delivery device, the needle having a forward end that is adapted to penetrate the skin of an animal;

a limiter that is substantially located at a distal end of the needle, wherein said limiter surrounds the needle and is fixed with respect to said outlet port and has a skin engaging surface that is adapted to be placed against the skin of the animal to receive an intradermal injection, the needle forward end extending away from the skin engaging surface a preselected distance from 0.5 mm to 3.0 mm which is set during manufacture of the intradermal delivery device such that the limiter limits an amount that the needle forward end penetrates the skin which is equivalent to the preselected distance and wherein the preselected distance is substantially less than the needle fixed length;

a receiver secured to the outlet port of the drug container, the receiver comprising a flange that rests against the body portion of the drug container, an extension that extends away from the flange in a direction opposite from the outlet port, wherein the needle is received within the extension, wherein the receiver supports a sealing membrane that closes the outlet port,

a hub portion that supports the needle and is secured at a first end via a snap fit arrangement within the extension of the receiver, wherein an opposite end of the hub portion includes a plurality of extensions that are nestingly received against abutment surfaces within the limiter, wherein the hub portion and the limiter are integrally molded as a single piece of plastic material, wherein the needle penetrates the sealing membrane when the hub portion is received within the extension of the receiver,

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,

wherein limiter comprises a plurality of ribs, and wherein the plurality of ribs are provided on an outer surface of the limiter and extend radially therefrom a greater distance than a remainder of the outer surface of the limiter.

2. The device of claim 1, wherein the skin engaging surface is generally flat and extends through a plane that is generally perpendicular to an axis of the needle.

3. The device of claim 1, wherein the skin engaging surface is continuous.

4. The device 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.

5. The device of claim 1, wherein the plurality of ribs extend beyond the skin engaging surface.

6. The device of claim 1, wherein the skin engaging surface is concave.

7. The device of claim 1, wherein the plurality of ribs does not extend beyond the skin engaging surface.

8. The device of claim 1, wherein the plurality of ribs provides structural integrity and facilitates handling of the intradermal delivery device.

9. An intradermal delivery device for use in making intradermal injections, comprising:

a drug container formed of two sheets of thermoplastic material including a body portion that is generally flat and surrounds a reservoir adapted to contain a selected substance and an outlet port that allows the substance to exit the reservoir during an injection;

a needle having a fixed length, wherein said fixed length is selected to be suitable for handling during manufacture of said intradermal delivery device, the needle having a forward end that is adapted to penetrate the skin of an animal;

a receiver secured to the outlet port of the drug container, the receiver comprising a flange that rests against the body portion of the drug container, an extension that extends away from the flange in a direction opposite from the outlet port, wherein the needle is received within the extension, wherein the receiver supports a sealing membrane that closes the outlet port;

a hub portion that supports the needle and is secured at a first end via a snap fit arrangement within the extension of the receiver, wherein the needle penetrates the sealing membrane when the hub portion is received within the extension of the receiver,

wherein the extension of the receiver provides a limiter that is substantially located at a distal end of the needle, wherein said limiter surrounds the needle and is fixed with respect to said outlet port and has a skin engaging surface that is adapted to be placed against the skin of the animal to receive an intradermal injection, the needle forward end extending away from the skin engaging surface a preselected distance from 0.5 mm to 3.0 mm which is set during manufacture of the intradermal delivery device such that the limiter limits an amount that the needle forward end penetrates the skin which is equivalent to the preselected distance and wherein the preselected distance is substantially less than the needle fixed length.

10. The device of claim 9, further comprising a needle shield removably provided on the hub portion and the needle, wherein the needle shield is configured to insert the hub portion and the needle within the receiver until the hub portion is received within the extension.