SE447446B - DEVICE FOR SUPPLYING MEDICALLY ACTIVE SUBSTANCES TO PROMOTE ABORTION - Google Patents

Description

447 446 2 correct the infection. The widening of a body canal or cavity can thus in itself have a beneficial effect. In addition, this effect can be combined with the predetermined effect in a manner to be shown below, which is the subject of the present invention.

The present invention has for its object to provide a device, made of a hydrogel body, adapted to be inserted into a cervix for dilating the same while locally administering an abortifacient substance. The purpose of the invention is achieved by carrying out: the device conforms to the features specified in patent l.

In the accompanying drawing, Fig. 1 shows the device in the applied position in a case of use; and in Figs. 2-4 different embodiments of the device are shown in section.

The device according to the invention is formed by a body of a material which, when brought into contact with a body fluid, swells by volume at least 20% measured. soni lim-iir (zxpzinsíoii. l-'rånselt svšillníngsförbågwan is the body mainly inert to the body-cut and surrounding tissues. The swelling of the body in contact with body fluid is preferably at least 40%, for example at least 80%.

The swelling can vary between 20 - 300% linear. The body is intended to be inserted into cavities in humans and animals, for example in the cervix and ureter.

In this way a widening of these channels is effected, whereby in the mentioned examples an abortion can be facilitated and the healing of a urinary tract infection can be prevented.

Because the material in the body is hydrophilic, it can be caused to absorb water-soluble or emulsifiable substances and the inventive idea is also to design the body so that its hydrophilic material contains active substances. As the body, due to its swellability, is well suited for insertion into and remains in body cavities, whereby it can be brought to a good abutment against the walls of the body cavity by suitable dimensioning and swelling factor, it is also well suited as a carrier for body active substances. , which is suitably applied topically by keeping the substance in question in contact with the body tissue for a certain period of time. In this case, the body tissue is thus the walls of the cavity, usually a mucous membrane.

An example is the induction of abortion by the insertion of a body of the type mentioned in the cervix and into the uterus. By inserting the body in its unswollen state, it can have small dimensions and thus it can be easily inserted while, after absorbing water from the body fluid, it swells and dilates the cervix. This facilitates the expulsion of the fetus, which is effected by supplying the abortion directly to the uterus by means of the body. The active: nibstauscii can be pro »luglzludíncr, .which (after cn-vim. Time effect has an abortifacient effect here. S 447 446 highly effective abortion agent, which carries small risks of damage to the exposed organs, in addition to which the active substance is delivered directly to the treatment site and can be given a locally effective dose without the human or animal body being exposed to any significant general effect. If prostaglandin were to be given instead in the form of a general dose by injection, for example, in order to achieve the intended effect, it must be given in such a large dose that a general effect in the form of vomiting, nausea and diarrhea was obtained.

Furthermore, the device according to the invention is advantageous for the pharmacological treatment in that the swollen body in its elastic state gives a very good infiltration to surrounding body tissues, whereby a very good and well-controllable transfer of the active substance can take place. The soft body is also tissue-friendly and can remain for a longer time without irritation. It can be adjusted within wide limits for the desired duration of the release of the active substances as well as the dosage. The geometric shape of the body introduced into the cavity is not critical and the body may, for example, be substantially cylindrical, spherical, ovoid or hourglass-shaped. However, it must have a cross-section and shape in general, which after swelling is adapted to the cross-section and shape which is the channel-shaped cavity. The cross section of the unswollen body is so much smaller than the cross section of the ltanal cavity that the body can be inserted into the cavity with play against its walls. whereby the introduction can take place with the least possible difficulty. A wire is suitably attached to the body so that it can be removed without surgical intervention. This thread can be made of an X-ray-tight material, so that the position of the body can be checked. The body may alternatively itself be of X-ray contrasting material.

The material in the body swells as mentioned in contact with the body fluid at least 40%, suitably at least 80% and can swell even as much as 300%. The material must otherwise be substantially inert to the body fluid and not be harmful to and not be resorbed by the body tissues. A suitable group of materials are hydrogels. These materials swell by absorbing water from the body fluid.

Suitable hydrogels are polymers and copolymers of the acrylic type, for example crosslinked polyacrylamide and polymers and copolymers of methacrylic acid esters with at least one hydroxy group in the side chain. Suitable monomer is Z-hydroxyethyl methacrylate, the ester group being derived from diethylene glycol or triethylene glycol. Also useful is, for example, 2,3-dihydroxypropyl methacrylate. As the crosslinking agent, polyfunctional acrylates are diesters or the like. glycols, for example ethylene glycol bis-methacrylate, are useful.

Another example of a material suitable for the body according to the invention is a copolymer of a hydrophilic monomer and a hydrophobic monomer. In this material 447 446 material, by varying the proportions between the hydrophilic and the hydrophobic monomer, the water absorption capacity and thus the swelling can be varied within wide limits. Examples of the hydrophilic component are monomers in the group consisting of N-vinyl pyrrolidones and vinylpyridines, and examples of the hydrophobic component are monomers in the group consisting of methyl acrylate and methyl methacrylate. Polymerization is conveniently effected by subjecting the starting materials to electromagnetic radiation in the ultraviolet-gamma radiation range or by heating. In this case, sterilization of the body is also achieved, which is important in the present context so that there is no risk of microorganisms being added to the body tissue. This is important as the device is intended for use in internal, and for infections susceptible body cavities.

Addition of the active substance to the material of the body can be effected by immersing it after the polymerization in a sterile solution or optionally emulsion with the active substance or substances in water. The body's hydrophilic material will then absorb the aqueous solution and the emulsion, respectively. If the water is then allowed to evaporate by evaporation, the active substance remains in the body's material and can then be released when the body is brought into contact again. with an aqueous fluid, thus the body fluid after insertion of the body.

By controlling the concentration of the liquid and the duration of the fluid uptake, the body can be impregnated with the active substance to different depths, which leads to different durations of the treatment, thus the body's uptake of the active substance, as well as the dosage. It is even possible to carry out the impregnation in several steps for a gradually changing concentration and possibly substance type, whereby a time-varying treatment can be achieved.

The body should be substantially elastic and only to a very small extent plastic. It can be stiff and / or hard in the swollen (not hydrated) state, but should suitably soften during swelling. The body may contain agents that make it more X-ray dense, such as salts of barium or bismuth or metal powder (eg silver).

In use, the body is inserted into the cavity in an unswollen state and then swells in contact. with bodyvšitszkan, so that the body, as at iriförandvt. can pass through the cavity, swell and be brought into good contact with the walls of the cavity. Due to the pressure which then arises on the body from the walls, the elastic body is compressed, at the same time as the elastic cavity walls may be expanded. The body thus rests well against the walls of the cavity and is held in position in the cavity. The inserted body can, if desired, be taken out again as the zildrngrxirigg 'when the body is combined with the adjacent trachea, in which case the drawing can take place. 447 446 (n The body thus acquires in its inserted position a good anchoring in the body canal or the cavity in which it is inserted, after the body material has absorbed body wellness and swelling. However, this takes some time and before this has occurred ufqrví. ~. ~: | r the body spell-um içczntemol.the surrounding tissue walls.As mentioned .iir body in herring fmvšilldu condition much smaller than the cavity or canal, that it can be easily inserted into the body cavity in question. In this case, the body must be inserted a longer distance into a body canal and thereby possibly pass a place which is narrower than the place where the body is to be located, a considerable undersize of the body is required.

However, the condition means that the body does not always receive a secure anchorage; until swelling has occurred and therefore an uncertainty period may arise immediately. after the insertion, when the body under unfavorable circumstances can move by flow of body fluid through the channel or movements of it. as here the inserted body. The body may, however, be equipped with at least one member of a material with an adapted rigidity. This member has external parts which, at least in the unswollen state of the body, project beyond the body, and so far that they come into contact with the walls of the surrounding cavity when the body has been inserted in the intended manner. In this way, these projecting parts thus act as locking means, which during suspension hold the body in its inserted place. Suitably these suspension means are designed with a locking action, so that they spring away in the direction of insertion, but strive to lock themselves out when moving out of the channel.

The projecting parts of the organ thus serve as anchoring only or mainly before the body has assumed its swollen state. They can therefore have such a dimension that they will for the most part be inside the surface of the body when it has assumed its swollen state and is thereby retained. This avoids that the protruding portions are pressed too much into the surrounding body tissue during the state of permanence, when the body has assumed its swollen state, nor during the extraction.

A device 1 according to the invention intended for insertion into a woman's uterus is shown in longitudinal section in Fig. 3. It is formed by an elongate body 2 of the said swellable material with a narrow end 3 and middle portion 7 and an outer spherical end 4. In the body 2 is inserted a wire 5 preferably of polyamide fibers which terminates inside the end 3 but extends from the body at the end 4 with a free part 6. It should be X-ray tight. A drainage channel 8 with openings 9 and 10 extends through the body.

Examples of suitable dimensions for the body 2 in the described application are a length in addition to the free part 6 of the trees of 70 mm and a maximum diameter of 4 mm at the end 4 and 12 mm for the middle part 7. 44? ¿44e 6 Fig. 1 shows a variant of the device for insertion into the uterus. If the device in the shape shown in Fig. 3 can be said to have a sponge shape, the device according to Fig. 4 is more hourglass-shaped, thus with both ends widened and the middle part designed as a narrower waist.

One or more means 11 for the said anchoring of the body which here is close to cylindrical is shown in Fig. 5. The means extends through it and has in the non-swell state of the body 2 projecting portions 12. The middle portion, from which the outer portions 1.2 emanate , is inside the material 2 of the body 2 even in its unswollen state and thus forms an anchorage for the member 11. In addition, the wire 5 extends through a hole 13 in the member, whereby an excellent anchoring of the member and the wire 5 in the material of the body 2 is mutually obtained. Fig. 1 shows the device 1 according to Fig. 3 inserted in the uterus of a woman.

The uterine cavity is denoted by 20 and the cervix by 24. As can be seen from the figure, the bud-shaped extension 4 of the device is located in the uterine cavity while the rest of its part extends through the cervix. After the body has been inserted, it absorbs water from the body fluid and swells. In this way it fills the cervix and dilates it. Through contact with the surrounding body tissues, they absorb the active substance carried by the body's material, in this case prostaglandins, which after a period of action have an abortifacient effect. Liquid which is formed and which is not absorbed by the material of the body can escape through the drainage channel S. As can be seen from the figure, the wire 5 extends through the uterine pin 21, thereby obtaining an indication that the device remains and an opportunity to pull out the body when the treatment is to end.

It is of course within the scope of the invention that a device of a similar type as the zin device 1 can be used for insertion into the uterus for the treatment of inflammation. The body must then be a carrier of, for example, some antibiotic. In the foregoing, an example has been shown of how the device can be designed and how it can be used. In addition to this, however, other designs are conceivable than those described above; The different elements of the device such as different mold elements, the pull-out wire and the anchoring means need not be bonded to each other in the manner indicated but can also be combined in other ways.

Claims (6)

1. 447 446 PATENT REQUIREMENTS 1. Device for supplying medically active substances and presenting a body »(2), which consists of a hydrogel which, in contact with white body particles, drips body fluid and thereby swells in volume and which is provided with the medically active substance. and arranged to be placed against the body tissue of a human or an animal, the medically active substance being of such a nature that it is able to be taken up by the body tissue when the substance is applied by the body and retained against the body tissue for a period of time, characterized in amber, that the body (2) is substantially elongated in shape and is arranged in its dimension to be at least partially accommodated in a living lofler neck. wherein the body to its cross-sectional dimerization in the swollen state is arranged to be able to be inserted into the cervix and to swell at least 402, calculated linearly and thereby dilate the cervix beyond its normal cross-section, with the medically active substance in the form of an abortifacient substance such as a prostaglandin, after hospitalization is suitable for promoting an abortion by simultaneously causing a dilation of the cervix and a transfer of the abortifacient substance to tissues surrounding the body. Device according to claim 1, characterized in that corypori (2) in its Išingtlliktí gen-Jmlršinges by a channel (8) arranged to pass through such body fluid, which would have its outlet through the cervix. Device according to claim 1 or 2, characterized in that the body (2) has at its central portion a cylindrical or slightly conical first portion (S, 7). and at least at one end a wider, bud-shaped end portion (4), the first portion being arranged to rest in the cervix while the second portion and the respective portions are arranged to be adjacent to its termination and terminations, respectively. fl. 4. Ancwrdníng according to something. of the preceding claims, characterized in that an indicator and pull-out wire (5) is attached to the body, which: a free end protrudes outside the body (2). 5. A device according to any one of the preceding claims, characterized in that locking means (12) are inserted into the body, with outer end portions which 447 446 8: niorrlriacie to rise when inserting the body into the cervix in insertion. - the direction, but to block out when trying to move the body towards the insertion direction. which means (12) are so arranged in the body (2) that the end portions project a relatively long distance outside the body in its unswollen state, but project a short distance or are completely inside the surface of the body in its swollen state. Device according to any one of the preceding claims, characterized in that the hydrogel in the body (2) consists of a copolymer of a hydrophilic monomer and a hydrophobic monomer, the swelling ability of the body being matched by the proportions between the two monomers.