FORM-2
THE PATENTS ACT 1970
(39 OF 1970)
&
THE PATENTS RULES, 2003
PROVISIONAL SPECIFICATION
(See section 10 and rule 13)
1. A NOVEL DEVICE FOR INTRADERMAL INJECTION.
2. CADILA PHARMACEUTICALS LIMITED. "Cadila Corporate Campus", Sarkhej-Dholka Road, Bhat, Ahmedabad-382210.
Gujarat, India
Nationality: An Indian Company.
3. The following specification describes the invention.

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FIELD OF INVNETION:
The present invention relates to a novel device for intradermal
injection.
The invention particularly involves device, which facilitate delivery of substances such as drugs, vaccines and the like used in the prevention, diagnosis, alleviation, treatment or cure of diseases into an intradermal space.
More specifically, the present invention relates to device capable of fixing the orientation of the syringe needle cannula assembly at an appropriate angle in relation to skin of injection site and limiting penetration of the tip of the needle cannula into the skin. BACKGROUND OF THE INVENTION:
Intradermal injections are used for delivering a variety of substances. Many of these substances have proven to be more effectively absorbed into or react with the immune response system of the body when injected intradermally. Recently, clinical trials have shown that hepatitis B vaccines, rabies vaccine administered intradermally are more imounogenic compared to intramuscular administration. In addition, substances have been injected intradermally for diagnostic testing, such as, for example using what is
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known in the art as the "Mantoux test" to determine the immunity status of the animal against tuberculosis and the immediate hypersensitivity status of Type I allergic diseases.
An intradermal injection is made by delivering the substance into epidermis and upper layers of the de rmis. Below the dermis layer is subcutaneous tissue, moreover there is considerable variation in the skin thickness both between individuals and within the same individual at different sites of the body. Generally, the outer skin layer, epidermis, has a thickness between 50-200 microns, and the dermis the inner and thicker layer of the skin, has a thickness between 1.5-3.5 mm. Therefore, a needle cannula that penetrates the skin deeper than about 3.0 mm has a potential of passing through the dermis layer of the skin and making the injection into the subcutaneous region, which may result in an insufficient immune response, especially where the substance to be delivered intradermally has not been indicated for subcutaneous injection. Also, the needle cannula may penetrate the skin at too shallow a depth to deliver the substance and result in what is commonly known in the art as a "wet injection" because of reflux of the substance from the injection site.
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The standard procedure for making an intradermal injection is known to be difficult to perform, and therefore dependent upon experience and technique of the healthcare worker. The procedure is recommended to be performed by stretching the skin, orienting the bevel of a 26 Gauge short bevel needle cannula upwardly and inserting the needle cannula to deliver a volume of 0.5 ml or less of the substance into the skin of an animal with the needle cannula being inserted into the skin at an angle varying from around 10- 15 degrees relative to the plane of the skin to form a blister or wheal in which the substance is deposited or otherwise contained. Accordingly, the technique utilized to perform the standard intradermal injection is difficult and requires the attention of trained nurse or medical doctor. This procedure also makes it essentially impossible to self- administer an intradermal injection. Inserting the needle to a depth greater than about 3.0 mm typically results in a failed intradermal injection because the substance being expelled through the cannula will be injected into the subcutaneous tissue of the animal. Further, the existing methods are not suitable for self-administration of intradermal injections.
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In addition to this, a mantoux procedure is relatively complicated and requires technical skill from the medical professional or an individual administering the injection. Mantoux procedure is painful for the individual receiving the injection.
US patent 5527288 describes an intradermal drug delivery device for delivering a liquid drug to a subject via the subject's skin comprises of: a housing having a lower surface provided with an adhesive coating for adhering the housing to the subject's skin; a drug reservoir within the housing, a single hollow needle associated with the drug reservoir extending through the lower surface, having an inner end communicating with the drug reservoir and an outer end projecting outwards a sufficient distance so as to penetrate through the epidermis and into the dermis when the housing is pressed against the skin; and means for actively discharging the drug from the reservoir to the subject's skin via the needle. Since the design of the device is very complex and economically it is not feasible to manufacture on large scale production.
US patent 5328483 describes, hypodermic injection device contained prepackaged unit dose of medication through a needle with an integral needle guard. Since, the device disclosed herein requires a
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specially designed injector and therefore, it is not readily adapted to be used with a variety of syringe types. Moreover, mass production of such device in manufacturing site is economically not feasible.
US patent 4886499 discloses a portable injection appliance comprises a supply vessel for retaining the formulation to be injected; an injection needle adapted to communicate with the vessel; pump for securing the appliance to an appropriate part of the patient's body. The device described in the said patent is highly specialized injectors. The design for this injectors include relatively complex arrangements of components that cannot be economically manufactured on a mass production scale. Therefore such devices have limited applicability and use.
Moreover, US 7083599, US 6494865, US 7083592 B2, 6971999 patents involve device consisting of different and highly specialized mechanism for the intradermal injection. While the other patents US 6,843,781 B2, US 7108679 B2, disclosed with intradermal syringe and needle assembly.
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There is a need for an intradermal injection device that is suitable for use with a conventional syringe needle assembly. Additionally, there is a need for an intradermal injection device that can be economically manufactured on a mass production scale. SUMMARY OF THE INVENTION:
The present invention provides a device for intradermal injection, which is suitable for use with a conventional syringe needle / cannula assembly and which can readily be used more particularly by persons with minimum of training.
An object of the present invention is to provide a device, which limits the penetration of the tip of the needle cannula into the skin.
The object of the invention is to provide a device for intradermal injections using conventional needle syringe assembly.
Another object of the invention is to administer drug intradermaly and not subcutaneously.
The other object of the invention is to provide a device, which engages syringe needle / cannula assembly to penetrate the skin at a fixed angle so that it enters intradermal space.
One more object is to provide a method of limiting penetration of needle into intradermal space by controlling protrusion of skin.
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The further object of the invention is to provide a device which causes protrusion of skin while delivering drug intradermally. BRIEF DESCRIPTION OF THE DRAWINGS:
Advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein some of the designs of the device as per present invention are illustrated. Each figure describes the device from different sectional view. DETAIL DESCRIPTION OF THE INVENTION:
The inventive device is described in Fig 1 to Fig 8. The novel device as per present invention is in the form of a block which has atleast one skin engaging surface (A) and containment mechanism for engaging needle syringe assembly (B) above the skin engaging surface wherein the angel between A and B guides introduction of distant and of B into superficial layers of skin. The distal portion of A optionally has a mechanism to limit protrusion of the skin, which will come in contact with distal part of B. A optionally has mechanisms to limit penetration of skin by B. The containment of B above A is longitudinally disposed such that the angle between A and B decides
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penetration of superficial layers of skin. Containment mechanism may hold whole or part of B. Containment mechanism can be a tunnel in the block, a slot in the block, clamp/s fixed to the block or combination thereof. The containment mechanism may be spring loaded to facilitate appropriate penetration of distal part of B.
Fig. 1-8 illustrate the device is in the form of a block which comprises skin engaging surface (A) and containment mechanism for engaging needle syringe assembly (B). They illustrate the block with section (A) skin engaging surface, containment mechanism for B at an angle to A. Fig 1-5 illustrate the containment mechanism as tunnel in the block. Fig. 6-8 illustrates a device wherein the containment mechanism for engaging needle syringe assembly (B) is in the form of slot in the block. Fig 3-8 also illustrates mechanism (extension) in the device which controls the protrusion of the skin.
The device disclosed in the present invention is held against skin surface for administration of the drug by means of a strap or adhesive or any type of holding mechanism. Conventional holding mechanisms such as those used in wristwatch, arm bend etc may be deployed. Fig. 1-8 has a mechanism to fix such a strap.
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While the invention has been described in conjunction with certain embodiments, it is understood that various modifications and changes may be made without departing from the spirit and scope of the invention.
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