FI97944C - Active substance delivery device - Google Patents

Description

97944

ACTIVE SUBSTANCE DISSEMINATION DEVICE - ANORDING FOR AVAILABILITY

The invention relates to a substantially T-shaped device for intrauterine use, such as a hormone.

A commonly used intrauterine device is a T-shaped body made of plastic 5, which comprises an elongate body part, the other end of which communicates with the transverse body, so that the body part and the transverse body together form a substantially T-shaped body. There is a partially wound copper wire around the body, which is capable of releasing copper ions. The device is inserted into the uterus with a separate applicator. A wire is attached to the device that is so long that it extends out of the cervix when the device is inserted.

T-shaped intrauterine devices that deliver hormones and other active ingredients are also known in the literature for the prevention and treatment of hormonal disorders. U.S. Patent 3,935,860 describes a T-shaped body comprising a walled container in which the hormone is: mixed with a carrier. The wall is the active substance • · 20 controlled release substances. A carrier, whether solid or liquid, contains the active ingredient, which is a progestin or estrogenic hormone.

U.S. Patent 4,014,988 also describes a T-shaped body comprising a walled container containing a progestin hormone mixed with a carrier. The wall is made of · controlled hormone releasing material.

U.S. Patents 4,264,575 to 4,264,578 describe • intrauterine devices in which the active ingredient is dispersed in a controlled release: 30 silicone polymer. The patent publications do not separately describe any device structures, but it is mentioned that the 2 97944 device can be, for example, T-shaped.

U.S. Patent 4,180,064 describes various intrauterine devices, e.g. A T-shaped device in which a progestin or estrogenic hormone is mixed with a biodegradable polymer.

Common to the T-shaped devices for delivering hormones or other active ingredients described above is that both the body of the device and its transverse body together form a single body. For this reason, the manufacture of the device 10 is complicated and expensive and the insertion of the device into the uterus is problematic.

The levonorgestrel-releasing inhibitor on the market comprises a T-shaped device with a jacketed polymer container containing 15 levonorgestrel hormones arranged around a vertical body made of polyethylene. One way to prepare it is published in International Patent Application PCT / FI93 / 00296. One feature of this solution is that when the device is placed in the uterus, the delivery of the active substance 20 takes place only in the lower part of the uterus. For the treatment of active substances used for contraception as well as for other purposes, it is advantageous for them to be delivered as high as possible in the uterus. Such a result • · · ·. ·. ·. is available if the active substance container 25 is placed higher in the T-piece than in a known levonorgestrel-releasing inhibitor.

. The object of the present invention is to obviate the above-mentioned shortcomings and to provide a new, substantially T-shaped, * · * intrauterine device containing the active substance, which is as effective as possible in terms of treatment and whose manufacturing technique is simple and placement · / uterus easy.

... The so-called cable tie is e.g. commonly used in the packaging industry

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- 97944 3 fastening members. It comprises a strip made of a flexible material, for example plastic, with a circumference formed at one end with grooves inside. The other end of the strip is threaded through the circumference to form 5 loops. The strip is provided along its entire length with ridges that fit into the grooves formed in the circumference. The ridges and grooves are shaped so that pulling the strip to tighten the loop is possible while pulling the strip in the opposite direction to loosen the loop 10 is impossible.

Some of the solutions of this invention are based on the use of cable tie technology.

The features of the invention appear from claim 1.

The polymer matrix container 15 containing the active substance may be surrounded by a membrane capable of releasing the active substance at a controlled rate.

For example, the active ingredient may be a hormone suitable for the treatment of menopausal disorders or contraception, in particular an estrogenic or progestin hormone.

20 The matrix container and the overlay containing the active substance may be made of the same or different

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J of a polymer or polymer blend. It is essential that • ·; ·. ·. a flexible polymer has been used in both the matrix and the possible end layer. Silicone polymers are *! ’.! 25 particularly suitable for this purpose.

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The invention will now be described with reference to the accompanying drawings, in which

Figure 1 shows a top view of a T-shape according to the invention; : 30 pieces in which the body part is locked to the transverse body by tightening the fastening member formed at the end of the body part around the transverse body 4 97944

Figure 2 shows a side view of the T-shaped piece of Figure 1

Figure 3 shows a T-shaped piece fitted to the setting tube 5

Figure 4 shows a cross-section of a body part in which the fastening member forms an integral part with the body part 10

Fig. 5 shows the body part of Fig. 4 according to another embodiment

Fig. 6 shows a body part of Fig. 4 according to a third embodiment Fig. 7 shows a body part of Fig. 4 according to a fourth embodiment

Fig. 8 shows a body portion of Fig. 4 according to a fifth embodiment

Fig. 9 shows a body portion of Fig. 4 according to a sixth embodiment ♦

Fig. 10 shows a body part f; ·. · To be connected to a transverse body, in which the fastening member is a separate body which can be locked to the body part. · · · · • «« · 25 Fig. 11 shows a T-shaped body in which the body part is also effective a polymer matrix container containing the substance

Fig. 12 shows a fastening member 30 suitable for connecting the body part and the transverse part of Fig. 11.

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Fig. 13 shows the fastening member of Fig. 12 according to another embodiment

Fig. 14 shows a T-shaped body in which two crosspieces 5 are connected to the body part. Fig. 15 shows a body part suitable for connecting two crosspieces.

Figure 1 shows a T-shaped body 10 according to the invention, in which the body part 20 is locked to the transverse body 40 by tightening a fastening member 22 formed at the end 21 10 of the body part around the so-called transverse body 40. according to bundling technology. The locking takes place in the circumference 25 at the end of the fastening member in a manner which is more clearly seen, for example, in Figures 4 and 5. An pull-out wire 50 is attached to the opposite end 23 of the body part 20. Figure 2 shows the T-shaped body of Figure 1 In this solution, the transverse body 40 comprises both a polymer matrix container 41 containing the active substance and a coating film 42 surrounding the container 41; '20 which is able to control the rate of release of the active substance. The ends 43a of the transverse body 40,:. 43b (Figure 1) are preferably uncoated. In this case ..A release of the active substance occurs faster · »· .... > ···· «·« * '· ends than the area covered by the membrane 42 and this is an advantage for the treatment result.

Figure 3 shows a T-shaped body from the front. . ·. fitted to the cut-out applicator tube 51.

«· · III ^ The dimension 25 of the circumference of the fastening member 22 corresponds to s learn my streak Haan. the outer diameter of the applicator tube 51. The figure shows that • the diameter of the fastening member 30 tapers upwards. This shape is:: particularly suitable for installation. The transverse body · '40 is made of a very flexible polymeric material and when the applicator is inserted through the cervix the double wings 44a, 44b 6 97944 of the body 40 fastening member 22 easily bend downwards so as to follow the applicator tube as indicated by the broken line as it passes through the cervix. The polymeric material must be flexible enough for the body 40 to extend inside the uterus again.

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Figure 4 is a cross-sectional view of one embodiment of the body portion 20 of the T-shaped body of Figures 1 to 3 and the looped fastening member. The fastening member 22, which is the same piece as the body part itself, also comprises a rim 25 formed at its end 10. The fastening member 22 is provided with ridges 27 at least in the region of the locking point, which lock into grooves 26 formed inside the rim 25. The ridges 27 and grooves 26 are thus formed the direction of the arrow EVENT tightening is possible, but the loosening direction of the arrow 15 in the opposite direction is prevented.

If desired, the body part 20 can be provided with ridges along its entire length, whereby the adjustment possibilities are not limited.

In Figure 5, the ridges 27 have been replaced by a single dovetail-shaped barb 27 'which locks against the lower surface of the circumference 25.

Fig. 6 shows a third embodiment of the body part 20 and the fastening member. The attachment member 25 is again of the same piece as the body portion itself, and it comprises an annular • · V 'circumferentially 25, a hole is just large enough so that a spherical bodies arranged in the frame part 28 can be pulled through the hole by pulling hard enough in the direction of the arrow.

. . ·. Figure 7 shows a fourth embodiment of the body part and the fastening member. The fastening member 22, which together with the body part • · * <· forms the same piece, is a loop, the ends '29 and 30 of which can be locked to each other by a dovetail-shaped barb 27' formed at the end 29 and formed at the end 30. ·. by means of the groove 26 '. 1

Figure 8 shows an embodiment of the body part and the fastening member Fifth 7 97944. The end 29 of the loop-forming fastening member 22 is provided with ridges 27 and the loop can be locked by inserting the end provided with ridges 29 to a desired depth into an opposite end 30 provided with grooves 26 such that after locking the end 29 is prevented from being pulled out of the end 30.

In Fig. 9, the fastening member 22 forms an open loop, the ends 29, 30 of which do not need to be locked together. In the manufacture of a T-shaped body, a transverse body 10 is pressed down between the flexible ends 29, 30. Due to the tension of the loop ends 29, 30, the transverse body remains in place in the grip of the loop.

Figure 10 shows a body part in which the fastening member 22 is a separate loop lockable in the body part 20. Its ends 29, 30 have barbs and the locking takes place when the ends are placed opposite each other and inserted into a groove 26 made in the shaped end 21 of the body part.

Figure 11 shows a T-shaped body in which the body 20 part 20 is also a polymer matrix container containing the active substance. The body portion 20 and the transverse body 40 are connected to each other by a separate: fastening member 22, which is shown in more detail in Figures 12 and 13. The operating principle of the fastening member of Figure 12 corresponds to: 25 the loops shown in Figure 9. A vertical loop 22 retains the transverse portion of the T-piece and a horizontal open loop 33 retains the end of the body portion. Due to the tension of the ends 34, 35 of the loop 33, the end of the body part remains firmly in the grip of the loop.

• · • · · • · · • *. . Fig. 13 shows an alternative solution of Fig. 12. Also in this solution, the vertical loop 22: holds the transverse part of the T-piece in place and the horizontal loop 33 holds the end of the body part. The ends are locked together by the principle of the solution 35 in Figure 7.

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Fig. 14 shows a T-shaped body in which two transverse bodies 40 and 40 'are connected to the body part, both of which comprise polymeric marice containers containing the active substance.

Fig. 15 shows a body part 20 suitable for fastening the two transverse pieces. The lower fastening member 22 ', which operates on the same fastening principle as the upper fastening member 10 22, opens to one of the two sides, and the lower cross member 40' is fastened by pushing it from the side into the loop 22 '.

In those solutions where the device 10 comprises two different polymer matrix containers, either with the device 15 having two transverse bodies 40, 40 'or with the body part 20 also forming a polymer matrix container, the containers may contain the same or different active substance. For example, one container may contain a hormone and the other a container an anti-inflammatory agent.

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It will be apparent to those skilled in the art that various embodiments of the invention may vary within the scope of the claims set forth below.

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Claims (3)

An intrauterine use intended and an active substance containing, substantially T-shaped piece (10), the soot comprises a longitudinal elongate portion (20), to which one end (21) has been attached a transverse elongated piece (40), such that This together with the body part (20) forms a substantially T-shaped piece (10), the transverse piece (40) comprising a polymer matrix container (41) for dispensing the active substance and the body part (20) either comprising a polymer matrix container for dispensing the the active substance 10 or that it is a piece which is not intended to contain any active substance characterized in that - the body part (20), which is a piece intended not to contain active substance and is made of a suitable material, is read at the the transverse piece (40) by feeding the part (22) partially or completely around the transverse piece (40), which is at the end (21) of the body part, and (i) the body part (20) and fasteners the member (22) forms a unitary piece, or (ii) the fastener (22) is a plate readable at the body member (20), or the body member (20) comprising a polymer matrix container intended for delivery of the active substance is attached to the body. transverse piece (40) by means of a legible fastening means (22) readable at the * ♦ ·· 'body part (20). • · • · ·: V 2. A T-shaped piece according to claim 1, characterized in that the body part (20) and the fastener (22) form a unitary piece, and there is also in the body part another fastener (22 ') to which another polymer matrix container is attached. (41 ') for delivery of an active substance. 3. A T-shaped piece according to claim 1 or 2, characterized in that the transverse piece (40, 40 ') consists of a polymer matrix container (41, 41') for dispensing the active substance and a film (42, 42 ') which 97944 surrounds this one, whereby the film shatters release the verksaituna substance at a predetermined rate. • «• • • • • · •« «