FORM - 2


THE PATENTS ACT, 1970
(39 OF 1970)
AND
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See section 10; rule 13)
AN APPLICATOR

HITECH PLAST LIMITED
an Indian Company of C/130, Solaris 1, Opp. L & T Gate No.6, Powai, Mumbai 400 072,
Maharashtra, India
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED


FIELD OF THE INVENTION
The present invention relates to applicator device. In particular, the present invention relates to applicator device for viscous material like vagina) or rectal gel.
BACKGROUND OF THE INVENTION & PRIOR ART
An applicator is an instrument for applying some liquid or viscous material, such as medicine, cosmetic, etc. Such applicators are used to administer medicaments to various body cavities like nasal cavity, oral cavity, auditory canal, navel cavity, vaginal and rectal cavities. Many of these parts are not easily accessible. Moreover, when self application is required, it becomes difficult for a person to apply the medicament properly and hence an applicator is required.
The applicators are made up of various materials like plastic, wood or glass. Various types of applicators are available in the market. One of such applicators is the graduated type applicator. More often than not, these graduations are difficult to visualize and hence there is difficulty in delivering accurate amount of medicament. This also leads to wastage of the medicament which is not sensible.
There are various demerits of over and under dosage of the medicament. Over dosage may lead to burning sensation, redness, stinging, itching of the skin, stomach cramps, skin rashes, headache, hives, etc.
On the contrary, underdosage of the medicament is not effective in carrying out the desired action. Thus, reapplication of the medicament may the required.
Further, over dosage results in oozing out of the excess medicament from the clothing, trickling down from the ear canal which is unhygienic.
Vaginal gels like contraceptive gel (spermicidal) and other microbicidal gels are applied with the help of an applicator.

A number of applicator devices have been designed in the prior art. Given below is a brief outline of some of the applicator devices known in the prior art.
International Patent Application No. PCT/US2004/001131 discloses vaginal or rectal applicators for the delivery of small volume of pharmaceutical preparation, i.e. less than lml. The delivery of a small volume of pharmaceutical preparation allows for the transvaginal delivery of the preparation to the region of the upper vaginal vault or rectum for the treatment of diseases and disorders of the female urogenital system, cervix, uterus, ovaries, fallopian tubes and peritoneal cavity and the lower abdomen. The vaginal or rectal applicators of this invention contain four main parts, an applicator barrel, a plunger, a plunger tip, an applicator cap. The applicator functions similar to a syringe. The applicator is filled with a pharmaceutical preparation with the plunger in the back position. The cap is attached to seal the pharmaceutical preparation in the applicator. To use the applicator, the cap is removed, the applicator is positioned, and the plunger is depressed. However, the applicator disclosed in this prior art document is suitable for the delivery of only a small volume of pharmaceutical preparation, i.e. less than 1 ml.
US Patent No. 6,537,260 discloses an applicator for applying or delivering a substance into a body cavity. The applicator includes a deformable reservoir for receiving and expelling the substance. The reservoir has an inlet spaced from an outlet, the inlet being configured to be connected to a container containing the substance. Valve means is positioned in the inlet to inhibit flow of the substance into the body cavity is in flow communication with the reservoir through the outlet of the reservoir. This applicator is not efficient in delivering precise volume of medicament.
US Patents Des.279,504, Des.294,063, Des.320,084 and Des. 494,676S disclose vaginal applicators with varying shapes and configurations. The problem associated with such applicator devices is the precision in delivering or applying the accurate amount of the medicament and hence are not user friendly. This inaccuracy may pose serious health hazards if the product to be applied is of therapeutic or other similar nature. Thus, there is a need for a device which aids in delivering accurate amount of product with ease and

comfort, consumes lesser time and at the same time avoids or minimizes any sort of wastage of the product.
The instant invention overcomes the limitations of the prior art and discloses an applicator device which ensures the delivery of accurate amount of product and is user
OBJECTS OF THE INVENTION
It is an object of the present invention to provide an applicator device.
It is another object of the present invention to provide an applicator device for viscous material.
It is yet another object of the present invention to provide an applicator device for viscous material like vaginal or rectal gel.
It is still another object of the present invention to provide an applicator device which is easy to operate and user friendly.
It is still another object of the present invention to provide an applicator which minimizes the wastage of medicament.
It is still another object of the present invention to provide an applicator device which is cost-effective.
STATEMENT OF THE INVENTION
Accordingly, the present invention relates to an applicator for dispensing precise quantities of a viscous material, said applicator comprising:
a. a barrel having a hollow body; an internal chamber defined in said hollow body having two sections: a first section for holding a precise volume of viscous material and having a pre-determined first cross-section and a

second section co-axial with the first section having a second cross-section; said second cross-section being greater than the first cross-section.
b. an opening defined at one end of said first section; and
c. a plunger co-axial with said first and second sections in its operative
configuration, said plunger having a resilient head having an external
cross-section complementary to said first cross-section and said plunger
being adapted to be displaced through the first and second sections in a
manner that during its traverse through the first section, the plunger head
applies a suction pressure at the opening, which suction pressure is broken
during the traverse through the second section for sucking precise volume
of viscous material in said first section.
Typically, said barrel has flange at its distal end.
Typically, said barrel is transparent.
In accordance with this invention, a nozzle is defined at the opening.
In accordance with another aspect of the invention, said plunger head is made up of a material selected from a group comprising Low-Density Polyethylene (LDPE), High-Density Polyethylene (HDPE), Linear Low-Density Polyethylene (LLDPE), elastomers and copolymers thereof, preferably LLDPE.
Typically, the distal end of said plunger is preferably cusp-shaped.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
The invention will now be described with the help of drawings in which:
Fig. 1(a) illustrates an applicator for viscous material in closed state i.e., plunger in non-extended position. This figure also reveals the second cross-section being greater than the first cross-section.

Fig. 1(b) illustrates an applicator for viscous material in open state i.e., plunger in extended position.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to an applicator for dispensing precise quantities of viscous material generally indicated by reference numeral 100.
As shown in Fig. 1(a), the applicator (100) consists of a barrel (10) having a hollow body (12) and an internal chamber (14) defined in said hollow body (12).
The internal chamber (14) has two sections (16 and 18). The first section (16) holds a precise volume of viscous material and has a pre-determined cross-section. The second section (18) is co-axial with the first section (16). The cross-section of the second section (18) is greater than the cross-section of the first section (16).
An opening (20) is defined at the end of the first section (16).
The applicator (100) for dispensing precise quantities of viscous material has a plunger (22) which in its operative configuration is co-axial with the first and second sections (16 and 18 respectively) of the internal chamber (14) of the barrel (10).
The plunger (22) has a resilient head (24). The external cross-section of the head (24) is complementary to the cross-section of the first section (16). The plunger (22) is adapted to be displaced through the first and second sections (16 and 18).
While traversing through the first section (16), the plunger head (24) applies a suction pressure at the opening (20). When the plunger head (24) reaches the second section (18), the suction pressure is broken because the cross section of the second section (18) is greater than the external cross-section of the plunger head (24) [as shown in Fig.l(b)], and no further viscous material is sucked through the opening (20). By adjusting the length of the first section (16), a precise volume of viscous material is introduced and held in the first section (16).

By reversing the movement of the plunger head (24), the viscous material held in the first section (16) is ejected through the opening (20) to the target site.
Typically, the barrel (10) has flange (26) at its distal end.
Typically, the barrel (10) is transparent.
Typically, a nozzle (28) is defined at the opening (20).
Typically, the plunger head (24) is made up of a material selected from a group comprising Low-Density Polyethylene (LDPE), High-Density Polyethylene (HDPE), Linear Low-Density Polyethylene (LLDPE), elastomers and copolymers thereof, preferably LLDPE.
Typically, distal end of said plunger (22) is preferably cusp-shaped.
Advantages of the Present invention: The instant invention provides several advantages, some of which are as follows:
• The applicator device of the instant invention can be used for delivering different types of viscous material including vaginal or rectal gel.
• The applicator of the present invention has a precise vacuum-breaking mechanism which ensures delivery of accurate amount of product at the desired site.
• Further, the applicator device disclosed in this invention is easy to operate and is user friendly.
• Moreover, the applicator device minimizes the wastage during delivery of the product and is cost-effective.
While considerable emphasis has been placed herein on the particular features of this invention, it will be appreciated that various modifications can be made, and that many changes can be made in the preferred embodiment without departing from the principles

of the invention. These and other modifications in the nature of the invention or the preferred embodiments will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is. to be interpreted merely as illustrative of the invention and not as a limitation.

We Claim:
1) An applicator for dispensing precise quantities of a viscous material, said
applicator comprising:
a. a barrel having a hollow body; an internal chamber defined in said hollow
body having two sections: a first section for holding a precise volume of
viscous material and having a pre-determined first cross-section and a
second section co-axial with the first section having a second cross-
section; said second cross-section being greater than the first cross-section.
b. an opening defined at one end of said first section; and
c. a plunger co-axial with said first and second sections in its operative
configuration, said plunger having a resilient head having an external
cross-section complementary to said first cross-section and said plunger
being adapted to be displaced through the first and second sections in a
manner that during its traverse through the first section, the plunger head
applies a suction pressure at the opening, which suction pressure is broken
during the traverse through the second section for sucking precise volume
of viscous material in said first section.
2) The applicator as claimed in claim 1, wherein said banel has flange at its distal end.
3) The applicator as claimed in claim 1, wherein said barrel is transparent.
4) The applicator as claimed in claim 1, wherein a nozzle is defined at the opening.
5) The applicator as claimed in claim 1, wherein said plunger head is made up of a material selected from a group comprising Low-Density Polyethylene (LDPE), High-Density Polyethylene (HDPE), Linear Low-Density Polyethylene (LLDPE), elastomers and copolymers thereof, preferably LLDPE.

6) The applicator as claimed in claim 1, wherein distal end of said plunger is preferably cusp-shaped.
7) An applicator as substantially herein described with reference to examples and figures.
Dated this 2nd day of January, 2009.