A PROCESS FOR THE OBTENTION OF INTRA UTERINE
CONTRACEPTIVE DEVICE AND INTRA UTERINE
CONTRACEPTIVE DEVICE.
The present invention refers to a process for the obtention of intra uterine contraceptive device and the corresponding intra uterine contraceptive device. Particularly, the present invention refers to a process which reduces or eliminates Human manipulation during the stages of production of the mentioned device and so producing a hygienic and perfectly sterilized ready-to-use device.
BACKGROUND OF THE INVENTION:
Intra uterine contraceptive devices of the art, the most common, are plastic material type having a "T" shape, and the opposing ends of the "T" top comprise have short gauge tubes of copper, and the vertical end of the "T" is reel covered by a thin copper wire and a thin cord for the contraceptive device removal from the uterus.
The above described device is placed into the applicator tube having a suitable gauge and the product is set ready-to-use into the sterilized package. In view of the device is dispackaged and applied in loco by qualified professional, i.e., the package is open and the product is applied directly into the uterus, is clearly seen that severe hygiene and sterilization conditions have to be taken in the manufacture phase. The process of the art presently employed comprises mechanical equipment and Human mounting operators for manipulation steps of the process.
Main steps related to the common process are: a) plastic injection for forming the "T" shaped piece; b) cutting copper tubes having suitable size for the "T" piece; c) sequence distribution of the pieces on the conveyor belt maintaining the same position for all pieces; d) supplying the copper tubes in storing apparatuses having conveyor belts for conducting the tubes to a double discharge end tube feeder; e) connection of the "T" pieces and the corresponding copper tubes in the tube feeder; f) mechanical narrowing of the "T" top parts by means of punction apparatus or any other apparatus of the art, in order to make a safe connection of the tubes and the top parts of the piece; g) The post- mounted products are conducted by conveyor belt to a reeling wire section where the thin copper wire is reeled around the vertical part of the "T" piece; h) the pieces are sequentially and manually placed on the axis of a reel machine for receiving the thin copper wire around the vertical part of the piece; i) the "T" shaped piece is conducted to a manual section for insertion of the cord; j) mechanically or manually disposed, the devices are used to feed a machine which is made for introduce the device into de application tube; k) the finished product is conducted to a packaging section for separated packaging, overpackaging of a set of packaged devices and sterilization.
As above decribed, many of the steps permits hand contact of the operators, although the use of sterilized protection means, as gloves and masks, a totally hygienic condition is not achieved. SUMMARY OF THE INVENTION:
According to the present invention, the process of the obtention of an intra uterine device is to have all menchanic steps, avoiding several preliminar steps and providing a fast, safe and hygienic process, for offer a more confident product and more fitted to an uterus application.
The process of the invention provides a robotized equipment at the initial part of the process, for mechanize the steps "a" to "f, turning said steps in a single one, the equipment provides a robot for feeding a plastic injection device having moulds receiving the copper tubes, resulting in the "T" shaped devices (T- devices) having the copper tubes immediately.
"T" shaped devices are withdrawn from the moulds by the same mechanical arms which conduct to a storing system standing by the reeling step and the cord insertion. Finished devices are conducted to be inserted into the application tube ( applicator), said tube can the common tubes of the art or, according to the invention, the application tube comprises a body which has able to coupling identical pieces, the pieces have longitudinal channel and the narrowed ends have transversal fitting bending channels. Inside these channels, the T-device is inserted, keeping the copper tubes and the cord positioned outwards after the identical pieces coupling.
The narrowed end of the applicator is connected to an elongated body being responsible for the conduction and positioning of the T-device inside the uterus.
Finally, manufactured product is sent to the packaging step for separated packaging of the finished T-devices, and to a final packaging step of the set of ready-to-use T- devices.
The process of the present invention is faster, more efficient and more confident in view of the art, due the fact that chances of contamination are avoided, the finished product is more fitted to the woman uterus and also facilitates the application, since the contraceptive devices of the art comprises a large gauge tube for receiving the T-device of the art previously folded and ready to be introduced into the uterus.
A person skilled in the art can see that, since the T-device of the art which is made of injected plastic material and being placed in a forced position into the applicator, it may curve the top parts of the T-device permanently, causing a not suitable application.
The T-device of the invention is maintained in a suitable position into the applicator and being ready to be applied into the uterus via an application piston which pushes the T- device through the applicator. The top parts return to the original form when inserted finally applied. BRIEF DECRIPTION OF THE DRAWINGS:
The follwing drawings are described below in order to offer a better comprehension of the description:
Figure 1 - illutrates a schematic presentation of the invention process;
Figure 2 - shows the process performed in the step a); Figures 3 and 4 - illustrate the intra uterine device presently obtained, this is an exploded view and a transversal plane section; and
Figures 5, 6 and 7 - illustrate the sequence of contraceptive introduction in a uterus. DISCLOSURE OF THE INVENTION:
Referring to the drawings the present invention discloses A PROCESS FOR THE OBTENTION OF INTRA UTERINE CONTRACEPTIVE DEVICE AND INTRA UTERINE CONTRACEPTIVE DEVICE, the process (P) is responsible for the contraceptive device (1) assembling, the device (1) is formed by a T-piece (2) having top parts (2a) with copper tubes (3), the vertical part (2b) is reeled by a copper wire (4), the part (2c) presents a hole (2d) receiving a cord (5) for extraction.
According to the present invention, the process (P) comprises the folowing steps: a) robotized station (R) for obtain the T-pieces (2) having top parts (2a) are injected into the tubes (3), for forming a single piece; b) conveyor belt conduction to a copper wire reeling station for reel the vertical part (2b) with a copper wire (4), the reeling is performed by a special machine having a micro motor which is able to make a synchronized reel movement; c) conveyor belt conduction to a manual cord insertion (5); d) totally assembled device (1) conduction to the mechanical station for insertion in applicator body (6); e) mechanical station for separated packaging of the applicator (6) containing the device (1), the outter tube (7) and the piston (8); f) packaging of sets of ready to use applicatiors in boxes; g) sterilization. The invention is presently disclosed. The step a), robotized station (R) is installed into a box witout Human access, except for inspection and repairs of the equipment, the station comprises a central mechanism (A) having a movable arm
(B) able to perform synchronized work with the equipment in order to take pairs of copper tubes (3), which are stored in feeding containers (C), transferring them (position x) to mould cavties of a plastic injection apparatus (D), which makes plastic material injection for forming the top parts (2a) of the T- piece (2) inside the copper tubes (3) the tubes are fixed by narowing the end boards.
When the injection apparatus is opened, the movable arm (B) withdrawn the pieces (2) injected in the tubes (3) (position y), conducting them to a storing rail (E). When the injection apparatus is on working, the arm (B) removes parts of the rail devices (E) and places these parts in a conveyor belt (F) (position w). The arm (B) keeps feeding the the injection apparatus (D) performing synchronized movements to return to the station (C) (position k). The belt (F) conducts the pieces (1) to the station (b) for palletizing and reeling the copper wire (4) in the part (2b), as previous described.
The resulting product is obtained by the referred process (P) and comprises an applicator body (6), formed by two identical pieces (6a) and (6b) being complementars by pins (6c) connection.
Each piece (6a-6b) has a longitudinal channel (6d) and narrowed edges (6e); the inner part of these edges (6e) is provided a transversal channel (6f) which are concurrent in relation to the channel extremity (6d) due the curves (6g). External extremities of the edges (6e) are threaded (6h) in order to receive the complementar extremity of conductor tube (7).
The cross portion made by the channels (6d- 6f) receives the device (1) and the cord (5) occupies the remaining part of the channel (6d).
In order to make effective the application of device (1) inside the uterus (U), the applicant have to introduce the conductor tube (7) in the uterus channel, pushing the device (1) by means of the piston (8).
When the device (1) is pushed through the body (6), the parts (2a) having copper tubes (3) are forced to be folded at the curves (6g), permitting the device (1) be introduced inside the tube(7).
Crossing the tube(7) due the piston (8) action, the parts (2a) return to the original shape causing therefore, a perfect positioning at the inner part of the uterus. As clearly see, the process of this invention provides better hygiene and sterilization conditions and the final product is suitable to an uterus introduction and is easily handled by a health professional. The invention also provides an ergonomic shape of the device, avoiding ulceration in the uterus cavity when the application is done.
The present description does not limit the scope of the invention, and other variantions of production steps, application, or many other embodiments can be foreseen from the present content.