MXPA97003985A - Insertion element for the placement of an intrauter device - Google Patents

Abstract

The present invention relates to an essentially T-shaped insert for the placement of an intrauterine device (IUD), said IUD comprises an elongated body having a transverse piece attached to one end of said body, said transverse piece comprises two wings, said insertion element comprises: a plunger having a front end adapted to receive the IUD and a rear end, a handle formed in or attached to the rear end of the plunger, a locking device operatively connected to said plunger, said plunger device. The latch is adapted to lock a bead attached to the IUD, such that the IUD remains stationary relative to the front end of the plunger, and a protective tube adapted to contain said IUD in a contracted configuration in which the wings of the IUD crosspiece, essentially in the form of T, are pressed with each other, said protective tube has a front end adapted for the insertion in the elongate, and a rear end, wherein the protective tube is adapted in sliding relation about the symbol, so that it can be pushed, at the front end, by passing the plunger at a distance that corresponds substantially along the IUD in said configuration contracted, and wherein the rear end of the protective tube has a first abutment surface operatively connected thereto, and wherein the plunger has a second abutment surface operatively connected thereto, located such that said second abutment surface will contact said first surface stop, thereby producing a stop movement of the protective tube in the lumbar direction, when the front end of the protective tube is in a position in which the tips of said wings, of the transverse piece of said T-shaped IUD , remain partially uncovered by the protective tube, but the wings, however, remain pressed one with the other

Description

ELE OF INSERTION FOR THE PLACE OF AN INTRAUTERINE DEVICE This invention relates to an insertion ele for the place of an intrauterine device. The invention also relates to a set of the insertion ele and the intrauterine device. An intrauterine contraceptive device (named intrauterine device = IUD) commonly used is a T-shaped object, made of plastic material, this object consists of an elongated ele that has at one end a transverse ele comprising two fins, this elongated ele and the transverse ele forms a substantially T-shaped part, when the device is placed inside the uterus. The elongated ele has a copper wire wrapped partially around it, this wire is capable of releasing copper ions. The device has an attached thread, long enough to protrude out of the cervical canal when the device is in place within the uterus. This device is inserted into the uterus by means of a separate insertion ele, the device is in a shrunken state during insertion, in order to facilitate its introduction through the cervical canal. The tips of the fins of the transverse ele are hemispherical in order to facilitate the introduction of the device, contained within the insertion ele, through the cervical canal. In addition to the T-shaped IUDs, for example, devices in the form of a ring, of a "7" or an "S" are known. There are also IUDs capable of releasing hormones or other active agents and they are used as contraceptives or for the treat of hormonal problems. There are several types of insertion eles for the place of intrauterine devices. The most common of these insertion eles for a T-shaped IUD consists of a piston with a handle, inside a protective tube. Preparing to place the device inside the uterus, the IUD, which is placed on the end of the plunger, retracts towards the handle so that the device enters the tube and the fins of the transverse ele of the device bend to each other. Then, the protective tube, with its content IUD, is introduced through the cervical canal. When the device is placed correctly, it is released by retracting the protective tube to the outside. The fins of the transverse ele are then expanded and the device assumes the configuration of a "T". A contraceptive device, which is available on the market and which releases levonorgestrel, consists of a T-shaped IUD, which has an elongated ele made of polyethylene, equipped with a reservoir fitted around it and containing the hormone levonorgestrel. The device is sold in a sterile package, together with the insertion ele with the plunger, which is a solid piece, contained within the protective tube. The T-shaped device is placed at the front end of the plunger with the elongated ele, which contains the hormone, protected by a tube. The fins of the transverse ele, on the other hand, expand in order to prevent fatigue. The cords by which the T-shaped device retracts outward, go between the plunger and the protection tube and the end, at the end of the handle. Figure 1 illustrates such a device. The T-shaped IUDs, which have an elongated ele wound with the copper wire, are packaged in a similar manner. A problem associated with the insertion eles of the T-shaped devices, which contain active compounds, refers to obtaining the correct place of the IUDs within the protective tube. The difficulty is due to the larger diameter of the elongated ele of these devices, compared to the IUD containing the copper wire, which means that the diameter of the protective tube is also greater. Lasa hemispherical end pieces of the fins of the transverse element are small in relation to the diameter of the protective tube. It is therefore extremely important that these end pieces are in the correct position exactly in relation to the edge of the protective tube at the moment of introducing the device into the uterus. Figure 2A shows an example of the correct placement of the T-shaped device inside the protective tube of the insertion element. If the IUD is pulled into the protective tube by means of the removal cord, which is the case with the devices described above, it will be understood that it is difficult to make the IUD stop in the correct position if the relative movement of the protective tube and the plunger are not restricted by some stop element. Pulling with too much force easily makes the tips of the fins of the transverse element enter almost completely into the protective tube (Figure 2B). During the insertion of the device, the sharp edges of the protective tube may interfere with the introduction of the device through the cervical canal. If, on the other hand, the device is not stretched sufficiently deep inside the protective tube, a situation like that shown in Figure 2c occurs, in which the fins of the transverse element project outward due to a protective tube too wide. . The diameter at the level of the fins remains too wide, which makes it more difficult to insert the device during insertion. It is easier to make the fins stop in the correct position (Figure 2D) in the case of copper wire devices, because the tube is narrow in relation to the fins. Therefore, there is no risk that the fins are thrown too deep into the tube, still pulling with great force. Methods are known in the patent literature, according to which the IUD is placed inside a protective tube when the device is introduced into the uterus. Patent GP 1,600,717 describes an insert suitable for IUD in the form of T or in the form of Y. The IUD is retracted into the protective tube by means of an attached cord. Patent publications US 3,842,826 and WO 94 / 13,233 also describe methods for retracting the IUD within a protective tube prior to the insertion of this IUD. GB 1,403,393 discloses a method in which the IUD, contained within a protective tube, is pushed towards the end of the tube, prior to insertion of the device. No prior method has been described in which an IUD is inserted into the protective tube, pushing the tube over the device, or pulling the device into the protective tube, where the relative movement of the plunger and protective tube is restricted by a protective element. cap, to make sure that the correct configuration of the IUD has been achieved. It is the object of the present invention to introduce an element to overcome the above-described problems and produce a new kind of insertion element, which allows the correct placement of the IUD also in those cases in which the elongated element of an IUD in the form of T contains active material, which implies a larger diameter than that of the elongated element of an IUD of copper wire. It is also our objective to produce an insertion element which is firm and stable and where some risk of non-resilient bending of the protective tube is involved. The features of the invention are described in claim 1. The invention will now be described with reference to the following drawings, in which: Figures 1A-1B illustrate the technical level of the unit combination of an insert element and an IUD; Figures 2A-2D illustrate the T-shaped IUDs, retracted within the protective tube, in the correct manner or in the wrong manner; Figures 3A-3D illustrate the operation principle of an insertion element according to the invention; Figures 4A-4B illustrate the configuration and the end of the plunger; and Figure 5 illustrates one embodiment of the invention. Figure 1A shows a design according to the technical level, in which the elongated element 45, in the form of T, of the IUD 40, has been placed inside the protective tube 12 of the insertion element, and the fins 42 and 43 of the cross-sectional element of the IUD expand. The plunger 11 is a solid rod with a handle 20 at one end. The withdrawal cords 41 go through the space between the plunger 11 and the protective tube 12. The reference 50 is a pointing device, which can slide along the surface of the protective tube and is placed in the desired location. When the IUD is inserted, the signaling device comes into contact with the cervical canal and signals the correct depth of the IDU placement. Before the device becomes operational, the withdrawal cord is pulled in the direction of the handle 20. This allows the entry of the IUD into the protective tube 12, at the time that the wings 42 and 43 are folded together. Figure IB shows the IUD protected by tube 12, in the form in which it is inserted. After the assembly of Figure IB has been placed inside the uterus, so that this IUD is correctly positioned, the IUD is released by retracting the protective tube 12 outwards, while the piston 11 is stationary.

Figures 3A and 3B show an embodiment of the invention, which illustrates the principle of operation. Figure 3A shows an insertion element 10 with an IUD 40 positioned at the front end (entry into the uterus), so that the elongate element 45 is inside the protective tube 12. Before insertion, the cord 41 it is tightened and locked in the locking device (not shown in the figure), associated with the plunger 11, with the tip of the elongated element abutting the end of the plunger. The method described in this figure involves a hollow plunger, and the cord 41 advantageously goes into the hole 13 of the plunger. The cord thus slides freely and there is no risk of its jamming between the plunger and the tube. This plunger has two abutting elements, which project radially, R2 and R4. The protective tube casing 12 has an axially directed groove 14 corresponding to the stop elements R2 and R4 (the cross section is shown in Figure 3C) and is designed to allow movement of the protective tube 12 in the axial direction . The sheath of the protective tube has a joined stop element R, with abutment surfaces Rl and R3 projecting in the direction of the radius of the piston. Figure 3D is a cross section showing the stop element R. Preparatory to the use of the device, the tightening and locking of the withdrawal cord is checked. Then, while retaining the handle of the plunger, the protective tube is pushed towards the IUD until the surface Rl of the stop element makes contact with the stop element R2, thus stopping the movement of the protective tube. At this time, the IUD is substantially inside the protective tube, and ready for insertion (Figure 3B). The location of the stop elements Rl and R2 is designed to allow pushing the protective tube past the plunger at a desired distance L, which corresponds substantially to the length of the assembled IUD for insertion. The stop elements Rl and R2 are advantageously located so that the edge 12a of the protective tube, which goes inside the uterus, is stopped at a level at which the hemispherical points 42a, 43a of the fins 42, 43 of the transverse element a T-shaped IUD, remain partially uncovered by the protective tube 12, while the fins 42, 43 remain still together. Alternatively, the surface Rl of the stop element R can be maintained in contact with the stop element R2, in which the protective tube extends by passing the plunger at a distance corresponding essentially to the length of the assembled IUD for insertion into the uterus. . If the IUD is placed inside the device, so that the elongated element 45 is placed inside the protective tube, but the fins 42, 43 are outside the protective tube, the IUD can be placed in the correct position to insert by stretching the IUD inside. of the protective tube.

The device, according to Figure 3B, is pushed into the uterus until the IUD is in the correct location. This IUD is released from the protective tube, while retaining the absolutely stationary piston, by retracting the protective tube towards the handle, until the stop surface R3 encounters the stop element R4 attached to the plunger. The location of the stop devices R3 and R4 has been selected so that, when these stop devices meet, they will clearly indicate the time at which the IUD, at the front end of the plunger, has been released from the protective tube, as it moves towards the handle. The stop element R4 can, but it is not necessary to be constructed such that it stops the movement of the protective tube in the direction of the handle. The stop elements R2 and R4, as shown in Figures 3A-3D, do not need to be attached to the plunger itself. Instead, they can be part of an element which connects itself to the plunger. The same applies to the stop elements Rl and R3. They can be attached to the protective tube itself or to an element connected to the protective tube. The stop elements Rl and R3 can be part of the same element R, as in Figures 3A-3B, but they can also be separate elements.

The plunger is advantageously hollow or has a groove that goes in the axial direction and allows the cord 41 to slide freely therein. It is important in the insertion of the T-shaped IUD that the fins can be projected laterally and not forward or backward (considered from the patient). The directional rigidity of the IUD during insertion can be ensured, for example, by configuring the forward end of the plunger, so that the IUD assumes a specific constant configuration when the cord retracts. The IUD will not twist like this during insertion. An example of such a design is presented in Figures 4A and 4B. The end 45b of the elongate element that abuts the plunger is configured as an eyelet, having a attached cord 41 for retraction. The figures show that the leading end Ia of the plunger is not level, but hollowed out to form a kind of shallow funnel. When the cord 41 attached to the eyelet 45b retracts, this eyelet 45b slides inside the funnel and is captured there. Figure 4A is a front view and Figure 4B is a side view of the eyelet 45. The front parts (directed towards the uterus) of the plunger and the protective tube may be straight or curved, to thereby conform to the anatomy of the uterus. A suitable embodiment of the invention is illustrated in Figure 5. The front portion 20 'of the handle 20 forms a construction 21 that runs in the longitudinal direction of the plunger. The construction has at the front end 21 'a channel, in which the protective tube 12 will slide in the longitudinal direction. This protective tube has an R button at the distal end (away from the uterus). The surface Rl, in the direction of the uterus, of the button R and the surface 21a, in the direction of the handle 20, of the end 21 * of the construction 21, together form a pair of stop elements Rl, R2. The edge R3, in the direction away from the uterus, of the button R, and the surface 21b of the base of the construction 21, together form a pair of stop elements R3, R4. If desired, one or more pointing devices can be arranged between the stop elements R1 / R2 and R3 / R4. Such a pointing device can, for example, be positioned in such a way that the doctor, when preparing to release the IUD, notices the moment in which the fins of the transverse element of the IUD have been released from the protective tube, while the elongated element is still protected by the tube. Such a pointing device, of course, must not effectively stop the retraction of the tube, because then the IUD could not be released. This invention provides an insertion element that allows easy placement of an IUD at a predetermined location within the protection tube, because the stop elements guarantee an exact placement of the IUD during insertion and its exact release. According to this invention, it is not necessary to provide too clear between the plunger and the protective tube, as in the insertion elements in which the IUDs are placed by retraction, without some stop element that stops the movement of these IUD. This results in an extremely stable construction, which does not imply risk of irremediable tube bending. The insertion element, according to the invention, is particularly suitable for the placement of the IUD in the form of a T, but is also applicable to other types of IUDs, as long as they can be managed to enter the protective tube by arrangements appropriate. While the invention is applicable to the placement of copper wire type IUDs, the advantages will be better appreciated in the case of devices containing active agents. An insert member, in accordance with this invention, is particularly suitable for the placement of such a T-shaped IUD, which has an elongated element 45, having a wrapper-type polymer reservoir, containing an active agent wound around the same. Suitable active agents include the hormones used for the treatment of menopausal problems or for contraception.

Those skilled in the art will appreciate that many variations and adaptations of the present invention will fall within the scope of the claims presented in the following section.

Claims (9)

1. CLAIMS 1. An insertion element, for the placement of an intrauterine device (IUD), essentially T-shaped, inside the uterus, this insertion element includes a plunger, a handle attached to the plunger, a cord, for the removal of the IUD, a locking device, to lock the cord, in such a way that the IUD remains immobile in relation to the plunger, and a protective tube around the plunger, in which this protective tube is adjusted in relation to the plunger in such a way that it can be pushed to the front end, which goes into the uterus, passing the plunger to the distance L, which corresponds substantially to the length of the IUD assembled by the insert, and the back the protective tube, or the piece connected to that part, has a stop element and the plunger or the piece connected thereto, has another stop element, in such a way that the stop elements stop the movement of the protective tube in the direction of the uterus, characterized by such u bite the stop elements that the front edge of the protective tube stops in a configuration in which the hemispherical tips of the transverse element fins of a T-shaped IUD remain partially uncovered by the protective tube, but the fins , nevertheless, they remain pressed together.
2. 2. The insertion element, according to claim 1, characterized in that the rear part of the protective tube, or the part connected to that part, has a stop element, and by the plunger or the piece connected to it, has another stop element, such that these stop elements, when they abut, indicate the time at which the protective tube, when moving towards the handle, releases the IUD, associated with the forward end of the plunger.
3. 3. The insertion element, according to claim 1 or 2, characterized in that the piston is hollow, so that the withdrawal cord of the IUD can go inside the plunger bore.
4. The insertion element, according to any of claims 1, 2 or 3, characterized in that the plunger has a concave front end, in which the tip of the elongate element of the IUD is captured, when the cord is tightened, and the twisting of the IUD during insertion is thus impeded.
5. 5. The insertion element according to any of claims 1 to 4, characterized in that the plunger parts and the protective tube, which are directed towards the uterus, have a curved shape.
6. The insertion element, according to any of claims 2 to 5, characterized in that the front part of the handle, or a piece connected to this part, forms a construction that goes in the direction of the plunger and contains at the front end a channel in which the protective tube slides in the longitudinal direction, and by the rear end of the tube having a button, with the front surface of the button and the surface of the end of the construction, directed toward the handle, forming together a pair of stop elements, and with the surface, directed away from the uterus, the button and the base surface of the construction, forming a pair of stop elements together.
7. 7. An assembly comprising an intrauterine device (IUD) and an insertion element, for the placement of the IUD inside the uterus, characterized in that the insertion element complies with the specifications of any of claims 1 to 6.
8. 8. The assembly , according to claim 7, characterized in that the elongated element of the IUD comprises a core piece, around which a wrapper-type polymer deposit containing an active agent has been adapted. The assembly, according to claim 8, characterized in that the active agent is a hormone, used for the treatment of menopausal problems or for contraception.