FORM 2
THE PATENTS ACT, 1970 (39 of 1970)
COMPLETE SPECIFICATION
(Section 10)
"A LOADNG DEVICE TO LOAD AN INTRA UTERINE DEVICE (COPPER T) SAFELY AND ASCEPTICALLY INTO THE UTERUS WITHOUT HUMAN TOUCH"
PREGNA INTERNATIONAL LIMITED,
Chakan-Talegaon Road,
Chakan,
PUNE-411501. Maharashtra State, India
An Indian Company registered under the
Provisions of the Companies Act,, 1956


The following specification describes the nature of this invention and the manner in which it is to be performed.

2 9 NOV-04

The present invention relates to a safe loading device for loading Intra Uterine Device (Copper "T") into the inserter before introduction into the uterus. This invention particularly relates to a well designed device with a perfectly designed profile to help safely load the Intra Uterine Device (IUD) into the uterus without any human touch to avoid possible bacterial infection when medical providers insert IUD into the uterus.
At present there are basically three ways of handling I.U.Ds to introduce it in the uterus (a) pouch containing I.U.D. is partially opened (b) pouch containing I.U.D. is fully opened, and (c) pouch containing I.U.D. is not opened.
Practice A : In this practice pouch containing I.U.D. is partially opened and the vital parts of I.U.D. Cu T 380 A are held by hand (with / without gloves) to bend horizontal arms of Copper T in to a specific shape to put in to inserter tube. After that IUD. can be introduced through cervix into the uterus.
Practice B : In this practice pouch containing I.U.D. has a component to fold horizontal arms of Copper T. For making use of this component, the pouch is required to be peeled open fully and the I.UD- components are exposed to the environment. Thereafter the various components are handled manually (with or -without gloves) to make I.U.D. ready for insertion.
Practice C : In this practice I.U.D. is loaded in the pouch without the help of any device and without opening the pouch. This is very difficult, cumbersome and in the process the pouch may get damaged and could deform the horizontal arms of the I.U.D.
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All the above practices have some drawbacks/deficiencies.
(1) Presently the medical providers have to struggle to load the Cu "T" by bending (preforming) the horizontal arms of IUD in a particular shape by hand and to get engaged in to the inserter tube prior to the IUD insertion.
(2) Medical providers invariably touch the IUD with or without gloves directly or indirectly which may cause bacterial infection.
(3) As the bending of Copper T arms is done manually (without having a specific designed profile) and the bent arms are engaged in to inserter manually, it may get deformed and may harm the user.
(4) The present practices are cumbersome and time consuming.
(5) Vital components of IUD are exposed to the environment, which may not have bacterial control.
Therefore, the purpose of this invention is to load IUD safely in to the inserter without any human touch prior to inserting the IUD into the uterus through cervix. This will totally protect the patient from any bacterial infection (that may be caused if it is done manually / without the help of any device). The device helps the IUD's horizontal arms to be in the exact pre designed uniform shape / form - a very smooth one and for ease in inserting the IUD through cervix in the uterus without any deformation.
The device as per the present invention comprises of a two part component assembly. The bottom half portion has profile and acts as guide to hold CT' in proper location and to keep insertion tube in its position securely in its recess, but at the same time guides it smoothly during bending operation by providing well designed guide ways. The upper half portion is provided with a well designed
profile guide ways at its bottom which acts as a smooth guide path to
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have horizontal arms bending in to a smooth required profile leading to proper assembly of 'T' arms and insertion tube. Both halves are firmly secured together by well designed locators and pins such that it acts as a one piece device and the operation of IUD insertion is carried out smoothly, easily and quickly without any touch.
According to the invention, therefore, a loading device to load an Intra Uterine Device (Copper T') safely and asceptically into the uterus without human touch comprises two part component assembly, a bottom half portion and an upper half portion, characterized in that the bottom half portion of the device has profile which acts as guide to hold the said intra uterine device (Copper 'T') and keeps the insertion tube in its position securely in its recess, and guides it smoothly during loading operation by providing well designed guide ways, the upper half portion is provided with a well designed profile at its bottom acting as a smooth guide path to have horizontal arms of the said Intra Uterine Device bending into a required profile leading to proper assembly of 'T' arms and the insertion tube; both the upper and bottom portions secured together by locators and pins to act as a one piece device.
The invention will now be described with the help of. accompanying drawings wherein the salient features have been shown with suitable numerals and referred to appropriately in the following description.
The drawing comprises 4 figures.
Fig. 1 shows the safe loading device in which the upper half portion and bottom half portion fitted together in male female arrangement as a single device.
Referring to fig. 2, which is the upper half portion of the safe loading device consisting of the designed profile (1), locating pins (2) and locators (3). The said locating pins (2) are placed on either side of the said designed profile (1).
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Referring to fig 3, which is the bottom half portion of the safe loading device consisting of guideway (4), four holes (5) placed equidistantly on either side of the guideway (4), Copper "T location (6) and slots (7) for the locators (3).
Fig.4 shows the complete safe loading device with pouch assembly.
Operation of the invention:
Stage I:
Opening the pouch partially at the other end of the device, which is kept in the
pouch along with the Copper "T" assembly, inserter tube and a solid rod, wherein
the Copper "T arms are located in the in the Copper "T" location and the inserter
tube is firmly secured in its location.
Stage II
Guiding the inserter tube along with copper T assembly into the guideway of the
safe loading device to give designed profile to the said copper T and to load the
inserter tube without human touch by arranging the inserter tube in such a fashion
so as to hold the bent Copper "T" arms firmly.
Stage in
Turning the said inserter tube with loaded copper T assembly along with the solid
rod at an angle of 90° clockwise or anti clockwise in vertical direction for easily
withdrawing from the said safe loading device just in time for inserting the I.U.D.
into the uterus.
Advantages of the invention are -
1. The first and foremost advantage of this device is to perform safely without any human touch operation of profiling and pre-forming of CU T arms (bending) and make perfectly Copper "T" assembly (Copper "T" with insertion tube) and thus achieve very safe loading of IUD.
2. As the device helps to bend horizontal arms with copper sleeves uniformly
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and smoothly because of well designed profile guideways, there is ease in introducing Copper "T" in uterus through cervix. The safe load device is also a 'easy load device'.
3. In the present practice, the medical provider has to perform "T bending and locating it inside insertion tube manually without any mechanical aid. This results into cumbersome, time consuming activity and some times it may get deformed also. The device is so perfect with its well-designed profile that this operation can be done quickly without any trouble ('quick load device') just in time prior to insertion.
4. General practice at present is to keep the Copper "T" 380A bent and keep it ready in an assembled form before actual insertion for sometime As with the help of this Safe load device, the assembly is easy and quick, this assembly can be done just in time before the actual insertion thus avoiding its prolonged exposure to environment, which may contain bacteria.
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WE CLAIM :
1. A loading device to load an Intra Uterine Device (Copper 'T') safely and asceptically into the uterus without human touch comprising two part component assembly, a bottom half portion and an upper half portion, characterized in that the bottom half portion of the device has profile which acts as guide to hold the said intra uterine device (Copper 'T') and keeps the insertion tube in its position securely in its recess, and guides it smoothly during loading operation by providing well designed guide ways, the upper half portion is provided with a well designed profile at its bottom acting as a smooth guide path to have horizontal arms of the said Intra Uterine Device bending into a required profile leading to proper assembly of "T arms and the insertion tube; both the upper and bottom portions secured together by locators and pins to act as a one piece device.
Dated this 23rd Day of November, 2002.

AGENT
FOR APPLICANT
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