WO2008139303A2

WO2008139303A2 - A novel device for intradermal injection

Info

Publication number: WO2008139303A2
Application number: PCT/IB2008/001151
Authority: WO
Inventors: Indravadan Ambalal Modi; Subodh Nanubhai Naik; Bakulesh Mafatlal Khamar
Original assignee: Cadila Pharmaceuticals Ltd.
Priority date: 2007-05-10
Filing date: 2008-05-09
Publication date: 2008-11-20
Also published as: WO2008139303A3

Abstract

A Novel device for Intradermal injection referred in figure 1 - 10 comprising bottom surface 'A' and top surface 'S'. It includes Channel /tunnel (1) to guide needle syringe assembly in intradermal space, on surface 'B'. Stoppering mechanism (2) to control penetration of the tip of the needle into intradermal space is provided along channel/tunnel. Holding mechanism (3) with a means to hold the device over injection site is provided at side of device. It also provides a Distal part (4) to control protrusion of skin to facilitate introduction of the tip of needle in intradermal space. The device engages syringe needle assembly to penetrate the skin at a fixed angle so that it only enters intradermal space. The device also provide a method of limiting penetration of needle into intradermal space by controlling protrusion of skin.

Description

Title: A NOVEL DEVICE FOR INTRADERMAL INJECTION. FIELD OF INVNETION:

The present invention relates to a novel device for intradermal injection.

The invention particularly involves a device, which facilitates 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 a device capable of fixing the orientation of the syringe needle cannula assembly at an appropriate angle in relation to skin at the injection site and limiting penetration of the tip of the needle cannula in the intradermal space so as to ensure delivery of the drug into the intradermal space . 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 system of the body when injected intradermalIy. 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, the "Mantoux test" to determine the immunity status of an animal against tuberculosis and the immediate hypersensitivity status of Type I allergic diseases. It is well accepted that the Mantoux procedure is painful and relatively complicated ats it requires technical skill from the medical professional or an individual administering the injection. An intradermal injection is delivered into the epidermis and upper layers of the dermis. Below the dermis layer are subcutaneous tissues, and 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. It is therefore imperative that a needle cannula penetrating the skin deeper than about 3.0 mm has the danger of passing through the dermis layer of the skin and delivering the drug by means of an injection into the subcutaneous region. Such an event would result in insufficient immune response, especially in cases of substances that necessarily need to be delivered intradermally. Further, the needle cannula may penetrate the skin at too shallow a depth to deliver the substance which could result in what is commonly known in the art as a "wet injection" because of reflux of the substance from the injection site.

The act of giving intradermal injection is difficult to perform, and therefore it requires experienced and technical person. The procedure for administration of intradermal injection invloves 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 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 in-is-r-t-ion i Q riiffiniU and requires the attention of trained nurse or medical doctor. 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. This procedure of giving intradermal injections makes the process of self-administration difficult and in several cases impossible. The existing methods are not suitable for self-administration of intradermal injections.

US patent 5527288 describes an intradermal drug delivery device for delivering a liquid drug to a subject via the subject's skin comprising 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, it is not feasible to manufacture this device on large scale production lines .

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 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 is commercially not feasible.

US patent 4886499 discloses a portable injection appliance comprises a housing having patient engaging surface to contact a patients skin,- 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 a highly specialized injector. The design for this injector includes relatively complex arrangements of components that cannot be economically manufactured and hence have found limited applications .

US patents 7083599, US 6494865, US 7083592 B2 , 6971999 disclose devices with varying and highly specialized mechanism for the intradermal injection. Other US patents 6,843,781 B2 , US 7108679 B2 , disclose intradermal syringe and needle assemblies .

There is a need for an intradermal injection device which is suitable for use with conventional syringe needle assemblies without the limitations of the prior art and that can be economically manufactured. SUMMARY OF THE INVENTION:

The present invention provides a device for intradermal injection, which is suitable for use with conventional syringe needle / cannula assemblies and which can readily be used by persons with minimum skill and training.

Another object of the present invention is to provide a device, which limits the penetration of the tip of the needle cannula in the intradermal space so as to deliver the drug in the intradermal space of the skin.

Yet another 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.

Yet another 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 only enters intradermal space .

Another object of the invention is to provide a method of limiting penetration of needle into intradermal space by controlling protrusion of skin.

Yet another object of the invention is to provide a device which causes adequate protrusion of skin for penetration of the needle into intradermal space while delivering drug intradermally. BREIF 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. Fig 1-8: shows different sectional view of the device comprising Channel/tunnel (1) , stoppering mechanism (2) , Holding mechanism (3) & Distal portion (4)

Fig 9 : shows front view of the intradermal device DETAIL DESCRIPTION OF THE INVENTION: The inventive device is described in Figures 1 - 9. A novel device for intradermal injection as referred in Figures comprising of, bottom surface "A" and top surface "B" wherein the surface "B" contains Channel/tunnel (1) , Stoppering mechanism (2) , optionally Holding mechanism (3) and optionally a Distal part (4) .

A novel device for intradermal injection as referred in Fig. 1 - 9 is in the form of a rectangle block comprising skin engaging bottom surface "A" and containment mechanism top surface "B" for needle syringe assembly above the skin engaging surface-. The needle syringe assembly for the purpose of this invention includes a drug reservoir with a mechanism to introduce drug into the body of a mammal including conventional syringes and its modifications with hypodermic needles & all its modifications. Figure 1 - 8 illustrate the block with section "A" skin engaging surface, containment mechanism for "B" at an angle to "A". Skin engaging surface "A" is curved and has a radius of 50-75 mm, preferably 66 mm. The angle between surface "A" and surface "B" guides introduction of needle syringe assembly in superficial layer of skin for intradermal injection.

A device as referred in Fig 1 - 9 wherein, surface "B" contains Channel /tunnel (1) to guide needle syringe assembly in intradermal space. Fig 6 - 9 illustrates a device wherein the containment mechanism "B" for engaging needle syringe assembly in the form of a channel in the block. Channel / tunnel (1) is at an angle' of 4 - 8° with surface "A" . Channel /tunnel (1) is having a distal end pointing upward (IA) and proximal end pointing downward (IB). Channel/tunnel (1) has width to accommodate syringe needle assembly in such a way that syringe n«-f-m«- acs^pmhiv i-^pinsin^ς in position throughout the process of intradermal drug delivery. Channel/tunnel (1) is either open in its entire length or covered in a part of a length.

A novel device as referred in Fig 1 - 3 contains stoppering mechanism (2) in the form of groove across the length of channel /tunnel (Fig 5-9) or at one or two ends of channel/tunnel. Stoppering mechanism (2) is in the form of constriction for penetration of needle syringe assembly (Fig. 1-4) , at one or both end or across the length of channel/tunnel (1) .

A novel device as referred in Fig 1 - 9 illustrates Holding mechanism. Construction of Holding (3) in a device is optional. Optionally Holding may hold whole or part of "B" by a slot or groove interlocking to enable fixing of a device. Holding is in the form of adjustable strap, any holding means used in wrist watch, arm belts, medical device, clamps fixed to the block or combination thereof with spring loaded to facilitate control protrusion of skin at distal part (4) .

A novel device as referred in Fig 3 - 9 illustrates mechanism in the device which controls the protrusion of the skin. A device contains distal part (4) in the surface "B" extended beyond distal end of channel/tunnel (IB) wherein channel/tunnel opens into an open area to allow penetration of needle syringe assembly. Open area may be circle, triangle or any other shape or in combination thereof. For penetration of needle syringe assembly. Diameter of distal portion (4) is in such a area for control protrusion of skin.

While the invention has been described in conjunction with certain embodiments, it is understood t-hat- varinnς mnrfifiral-ions and changes may be made without departing from the spirit and scope of the invention.

A novel device is used for intradermal drug delivery into the skin. It is typically given over the deltoid region of upper arm. The device is attached to the skin by holding it with the use of holding mechanism on upper arm. The device is held in such a way that surface "A" lies over skin. The distal end of device (1) lies away from site of injection while skin protrusion control mechanism (4) surrounds proposed site of injection. The syringe needle assembly is fixed in such a way in a channel/tunnel that needle remains outside skin with bevel facing upwards . The syringe needle assembly is gradually advanced in a tunnel for penetration of skin &^■ introduction of tip of the needle in intradermal space till it is stopped by stoppering mechanism (2) . The position of bevel of needle is inspected visually to ensure its entire length to be in '^intradermal space. The plunger of syringe is moved forward to have drug delivered into intradermal space. The intradermal injection give per de orange appearance to skin at the site of injection. Drug substance is injected into the skin through the needle syringe assembly and penetrating the needle over^' the control of the device with a adequate protrusion of the skin.

Claims

We claim,

1. A Novel device for Intradermal injection comprising bottom surface A and top surface B wherein the surface B contains Channel/tunnel (1) to guide needle syringe assembly in intradermal space, Stoppering mechanism (2) to control penetration of the tip of the needle into intradermal space, Optionally Holding mechanism (3) with a means to hold the device over injection site and Optionally a Distal part (4) with a means to control protrusion of skin to facilitate introduction of the tip of needle in intradermal space.

2. Surface A as claimed in claim 1 is curved, has radius of 50-75 mm.

3. Surface A as claimed in claim 1 & 2 has radius preferably 66 mm.

4. A novel device as claimed in claim 1 wherein Channel/tunnel is at an angle with surface A, preferably with 4 to 8°.

5. A novel device as claimed in claim 1 & 4 wherein Channel/tunnel is having distal end pointing upward (IA) and proximal end pointing downward (IB) .

6. Channel/tunnel as claimed in claim 1, 4 and 5 has width to accommodate syringe needle assembly in such a way that syringe needle assembly remains in position throughout the process of intradermal drug delivery.

7. Channel/tunnel as claimed in claim 4 to 6 is either open in its entire length or covered in an entire length or part of a length.

8. The Stoppering mechanism as claimed in claim 1 is in the form of groove across the length of channel/ tunnel or at one or two ends of channel/tunnel .

9. The Stoppering mechanism as claimed in claim 1 is in the form of constriction at one or both end or across the length of channel/tunnel .

10. The construction of Holding mechanism as claimed in claim 1 is optionally adapted to have slot or groove interlocking to enable fixing a device.

11. Holding mechanism as claimed in claim 10 for fixing a device by using adjustable straps and any holding means as used in wrist watch, arm belts, medical device etc.

12. A novel device contains Distal part to control protrusion of skin as claimed in claim 1 is in the surface B extending beyond distal end of channel/tunnel (IB) wherein channel/tunnel opens into an open area to allow penetration of needle syringe assembly.

13. A novel device for intradermal injection having an open area to control protrusion of skin as claimed in claim 12 is circle, triangle, or any other shape or in combination thereof.