DE2320250A1 - ABORTUS FACILITATING DEVICE - Google Patents

Description

23 713

Morton Gutnick, Elkins Park, Pa / USA

Abortion-relieving device

The invention relates to a device for widening the building cervix for performing abortions. Of the more describes a method for performing the abortion. Kit of the device according to the invention can be attached to the neck of the building expand and thus facilitate the abortion and in some cases initiate a spontaneous abortion.

Although cervical dilators for widening the neck of the uterus and to facilitate labor during childbirth are known from US Pat. No. 3,480,017 satisfactory techniques and devices for

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pain-free widening of the; Building motherhood prior to making one, abortion does not develop, and further is a device or a procedure to generally facilitate the abortion and in some cases spontaneous. Initiate the same not been described.

When carrying out abortions by means of a technique in which the widening of the uterine neck is necessary to introduce a vacuum device to accomplish the abortion, up to now the widening of the uterine neck by means of steel dilators has been carried out. These were operated in such a way that the building cervix was stretched and stimulated in such a way that it widened relatively quickly to the desired size for the abortion. The extent of the cervical enlargement depends on the pregnancy status and ranges from about 10 mm for a pregnancy in about the fifth or sixth week to about Ik mm for a pregnancy in the third or fourth month. The treatment of the cervical cervix: with steel dilators often leads to tears and injuries to the neck of the uterus, which occasionally cause such serious injuries that they have to be sewn through. Furthermore, the use of steel dilators occasionally perforates the uterus, which is an extremely serious injury.

In addition, there was previously no device for initiation of abortions in the case of late pregnancy, i.e. in the area of 17 weeks and the times after injection of hypertonic saline remedies and before a miscarriage to accelerate, or sometimes the miscarriage without injection to initiate hypertonic saline remedies.

In contrast, the invention is based on the object ^ a Device for painless and relatively safe expansion of the neck of the back of a patient as the preceding one

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Step for performing an abortion and for introducing a foreign body into the uterus to stimulate a spontaneous one Creating abortion.

Another object of the invention is to provide an apparatus _; with which a preabortional widening of the building cervix can be carried out in such a way that the walls of the building cervix can be widened slowly and gradually at a controlled speed under the pressure of an expansion element.

Another object of the invention is to provide an apparatus of the type mentioned, which has an expansion element for uniform radial and gradual expansion of the cervix is provided and relative painless and without damaging the cervix or of the uterus can be inserted. At the same time, the device according to the invention should contain means that are inserted into the neck of the uterus penetrate and act as a foreign body, so that the pregnancy is interrupted, and which serve to to anchor the device during its use so that inadvertent displacement of the same can be avoided. In addition, the device according to the invention should have means be provided, which allow a drainage of fluid from the uterus and an introduction of fluids into the same target.

Another object of the invention is to provide a cervical enlargement device that comes in various sizes can be made so that it is optimally used for performing abortions in various states of pregnancy is possible.

The device according to the invention should si ch easily in the Cervix and uterine cavity painless and with one

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Allow minimum discomfort and pain to be introduced.

In addition, the device according to the invention is intended to stimulate the lower part of the uterus and put the uterus in a state of stimulating labor, so that by doing so a rapid miscarriage is induced in pregnancies seventeen weeks or more, or occasionally such a late pregnancy is spontaneously interrupted without the use of labor stimulants.

According to the invention, this is achieved by an elongated / solid, flexible, tubular body with a proximal and distal end of at least two near its proximal end End-commencing conduits forms an expandable circumferential expansion element integral with the tubular Body that ranges in length from about 5 cro to about 6 cm, the element in the unexpanded state having a. Cross-sectional dimension of about the same size as the cross-sectional dimension of the remainder of the tubular body has, while in the expanded state its Cross-sectional dimension is in the range from about 1.5 cm to about cm and its shape is essentially that of a cylinder with rounded ends "-" is integral with an expandable circumferential anchor on the tubular body, which is formed on the distal side of the expansion element at a distance therefrom and a cross-sectional dimension when fully expanded which is substantially equal to the expanded cross-sectional dimension of the expansion element, one of the two Lines with the interior of the expansion element and the other line with the interior of the anchoring element in connection stands. ■ ......

The abortion-facilitating device according to the invention therefore comprises a thin elongate device with a

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rounded distal end and a proximal end, which preferably ends in three separate lines. Each line is associated with a specific one, within the facility per se defined channel in connection. A channel is with the expansion element connected to the device, which is located ± n substantial distance from the distal end of the device is. The expansion element has in the folded together Condition essentially the same dimensions as the cross-section of the body of the device while in the expanded state State it has a cylindrical shape borrowed in the Weserfc assumes a cross-sectional dimension ranging from about 1.5 cm to 4 cm, with its length about 5 cm to about 6 cm amounts to. In the expanded state, the expansion element retains its substantially cylindrical shape with rounded ones Ends at so that the expansion element on it. surrounding The cervix exerts an even pressure.

Distal from the expansion element by about 1 centimeter to about An anchoring element is provided 1.5 cm away, which extends into the uterus and, prior to expansion, is the same cross-sectional dimension as the body of the device. When inserted into the uterus, the anchoring element acts as a Foreign body, (with its tip as an abortion-relieving agent) and when it is expanded it becomes the pregnancy interrupt. The uterus is stimulated to expel the foreign body and occasionally a spontaneous abortion is induced. The anchoring element is fed from a separate conduit in the body of the device with fluid to a To be expanded cross-sectional dimension, which is approximately equal to the cross-sectional dimension of the expansion element. It will when used before the expansion element is expanded, it is used to anchor the cervical expansion unit. In the expanded state, the diameter of the anchoring element is approximately equal to the diameter of the expansion element. Therefore, in the event of a spontaneous, the anchoring element

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tanen \ boi * tas niefot the nmtürllehe itastrelben derEinheit ^ since his Burebiiesser equal to the expanded opening of the Gebährnnitterhalses 1st- Ib close range \ roa prosdiÄalen end of Erwelterungseleiientes · Is one. Faar wings arranged, which extend sJLeii qper zub body of the ■ device, and each have a single opening. The wings serve as an aid for lacquering the EinrleteoBg mdLfc the cervical expansion element inoerfoalb the Cj-ebibrmiilfcfceFlialses ^ tHadie the openings in the wings facilitate an opening in the wing the EiEieielätang; iiireB Eimsatearfc and the Hlnäojrcfiileifeen of a T'enacle.

The proodlmale end of the catheter ends in three lines, one for the supply of one for the Aufweiifengs- or "TeranfeeruogseletEent" and one a main channel is located in the body of the device and looks through this up to. A point at the hub of the rounded tip extends at its dlstal end «The last-mentioned channel enables a fluid to be discharged from the. Uterus and the introduction of iron medicaments - In the same., Each line to the anchoring or "Aufweltengs ^ element leading" line should preferably be provided with a suitable Tentilelnrichtung at its proüdLmalen end, so that. A device for the introduction of the fluid to the. Two can be connected expandable elements "bie to AEEN main channel connected line for introducing vein removal of fluid to or from the uterus is preferably left open, the fluid or medicament into the uterlnären cavity through a Spülsaugspritze example, mono- or au-sgeleltet can be" ·

In a preferred embodiment of the invention, the abortion reliever in a number of different sizes with slightly different dimensions Manufactured for use in various states of pregnancy.

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Any: Abortion facilitating device is preferably made of a medically acceptable, strong, but flexible material and is preferably in sterile packaging packaged for single use.

The inventive method comprises inserting the dilator into and through the uterine neck so that the distal end extends into the lower portion of the uterine cavity and expanding the anchoring element by introducing a fluid so that accidental slippage of the dilator is avoided . Furthermore, the expansion element, which occupies the entire length of the neck of the birth mother, is expanded uniformly and gradually radially up to a cross-sectional dimension of approximately 1.5 ctn to 4 cm and _N more, this depending on the pregnancy state of the patient to be treated. Has the desired degree of expansion been achieved, which is best after four or more times? Hours is the case, the abortion-relieving unit remains in place for a considerable period of time, preferably overnight Folded catheter body corresponding dimensions and also pulled the anchoring element together to its normal dimensions, so that the device can be removed. With the dilator in situ, fluid can be removed or introduced from the uterine cavity through a conduit that communicates with the proximal end of the catheter. The lead extends outwardly through the patient's vagina during the expansion procedure, while the distal end of the lead is located within the patient's uterus. during the presence of the device according to the invention in the uterus, the pregnancy is'"through the distal segment of the

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Device and interrupted by the expansion of the anchoring element, or is hereby due to the presence of a Foreign body in the uterus stimulates a spontaneous abortion.

An embodiment of the invention is based on the drawing explained in more detail below. Show it:

Figure 1 is a fragmentary front view of the device of the present invention encased in a sterile package before use,

2 shows a fragmentary front view of the device according to the invention in the fully expanded state;

3 shows a cross section along the section line j5-J5 ■ Fig. "2,

Fig. H. _Ä a cross section along the section line 4-Λ according to Fig. 2,

Fig. 5 shows a cross section along the section line 5-5 of Fig. 2, and

Figure 6 is a schematic view of the uterus showing the operative end of the device of the invention in place when expanded.

According to FIG. 2, the unit facilitating the abortion according to FIG of the invention has the general reference number 8 and comprises a device marked with the general reference number 10, Polygamy consists of an elongated body that consists of a medically acceptable sterilizable rigid and flexible material and is described in more detail below. The body ends at its distal end in a round point 12 and at its proximal end in three separate lines ^,

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which are provided with the relevant reference numerals 14, 16 and 18 are. The lines 14, 16 and 18 are integrally formed on the device 10 at its proximal end 20 and with the Establishment connected. The device 10 forms three individual channels 24, 26 and 28 between its proximal ends 20, see in particular Pig. 4 extending to the distal end 12 of the device. The longest canal that extends canal 28 / away from the proximal end of the device where it is in Pluid connection with the channel 18 is, up to one near the distal end 12 of the device spaced apart location, ViO the channel 28 with a plurality of openings 30 connected is. These openings extend to the surface of the tip 12 and allow fluid flow from the environment at the distal End of the device in the channel 28 and from this in the channel 13 and an exit of the same through the proximal End 38 of line 18.

In order to avoid any confusion, if desired, Each line 14, 16 and 18 can be provided with a label which in each case an identifying note regarding the particular connection that the individual lines create, having. For example, the line 14 labeled "Anchor ^" the line 16 labeled "Dilator" and the line 18 labeled "Uterus". provided v / earth.

The channel 24 extends to a point inferiorly remote from the distal end 12 of the device and overhangs one Transverse channel 34, see Fig. 3, in fluid communication with the inflatable Anchoring portion or body 44 of the device. The anchoring portion 44 is in Fig. 1 in the folded State and shown in Figs. 2 and 6 in the expanded state. The anchoring body 44 comprises a thin, expandable circumferential membrane similar to a balloon attached to the outer Surface of the device 10 is formed and has substantially the same cross-sectional dimension and shape as the rest of the

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Body of the device 12, if they look in the collapsed state according to Pig. I is located. Make an introduction of a fluid through the line 14 into the channel 24 and through the channel j54 to the Ve ranke approximately organ 44, this becomes the flattened one inflated annular shape according to FIG. 2, the anchoring element 44 preferably having a maximum Diameters in the range from about 1.5 cm to about 4 cm approximately equal to the inflated diameter of the expansion element 46 occupies; different sizes of the abortion reliever unit have different maximum diameters depending on the state of pregnancy for which the device according to the invention is used.

Furthermore, on the outer periphery of the device 10 is an inflatable Expansion element 46 is formed. The expansion element 46 similarly comprises a thin, circumferential expandable membrane a balloon, which in the folded state according to Fig. 1 shows a. Cross section approximately the same as the cross section of the device and, after being expanded, assumes an essentially cylindrical shape with rounded ends as shown in FIG. The expansion element 46 is through a transverse channel 36 in the Body of device 10 in fluid communication with channel 26, so that it is by introducing a fluid into the channel 26 over inflate channel 16 and thereafter through transverse channel 36 can be. The upper end of the expansion element 46 is approximately 1.0 to 1.5 cm below the lower end of the anchoring element 44 arranged for the purpose described in more detail below.

The dimensions of the expansion element 46 can be accordingly the state of pregnancy of the patient, her building cervix should be expanded, changed; the dimensional differences are also described in more detail below.

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At the end of the 6th to 12th week of pregnancy, the widening element 46 has a diameter of approximately 3 cm and a longitudinal extent of approximately 6 cm in the expanded state. The structure of the expansion element 46 is such that the longitudinal regions of the outer wall l ± 8

- lie approximately parallel and also remain approximately parallel when the expansion element expands from the folded state according to FIG. 1 to the inflated state according to FIG. 2.

Inward to the proximal end of the expansion element 46 and at a distance of about 1 cm from it is a second Arranged anchoring element 50, which according to Figure 5 two loop-shaped portions 52 formed on opposite sides of the device 10. Each loop forms ^ .a central opening 54. The anchorage ent 50 serves da. ^ u, anchoring the establishment in place too as described in more detail below.

The distal end 12 of the unit has a rounded tip about 0.5 cm in length, the distance from the tip to the distal end of anchoring element 44 approximately 2.0 to 3 * 5 cm.

The distance from the proximal end of the anchoring element 50 to the proximal end of the line 18 in the preferred embodiment of the configuration is about 30 to about 32 cm.

The diameter of the device 10 is preferably in the range from about 5 mm to about 7 mm. The anchoring elements 50 have a longitudinal dimension of about 3 mm.

The abortion facilitating the device according to the invention consists of a sterilizable medically acceptable never ht toxic and non-irritating material of a known

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Kind, such as latex, rubber, silicone rubber or Silastik, a silicone elastomer. Depending on the particular rigidity of the material from which the device is made, it may be appropriate to use a coarse fabric (scrim) of Dacron or similar material in the material of the facility to be molded in a known manner, so that greater rigidity and thus more convenient handling is achieved the abortion relieving unit according to the invention is preferably made from a unitary body of material in a known manner shaped, although it is also within the scope of the invention to form separate elements and to use adhesives, Plasticizers or other known techniques or To combine resources.

It may also be desirable to have a reinforcing fabric made from it Dacron or similar material in the wall 48 of the expansion element 46 to ensure that the dimensional consistency of the expansion body is maintained is, or this its substantially cylindrical shape takes when it is against the wall of the uterine neck is expanded in the manner previously described.

According to FIG. 1, the device according to the invention in a closed and hermetically sealed envelope 60 is better known Kind of packed and is sterilized in the sleeve in which one For example, initially the envelope with the device located therein is evacuated and then the interior of the envelope is evacuated a sterilizing medium such as ethylene oxide fills up and then evacuated and sealed. To this In this way, the sterility of the unit is guaranteed before it is used.

When making the cervical dilator according to of the invention, the ends j54 or. j56 of lines 14. and 16 with a removable membrane in a known manner

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Rubber, latex or the like are provided, so that the sterility of the interior of the lines 14 and 16 and the channels 24 and 2.6 is maintained when the sewn on is placed in situ. As an alternative to this, each line or one or more lines could be provided with a Luer lock adapter inserted therein so that connection of the lines concerned to suitable Eustachian tubes or other means for introducing fluids with suitable Luer elements in a known manner is possible.

The device according to the invention and the method according to the invention for its application are used to carry out an abortion, which is usually carried out by enlargement and scraping or, in the case of seventeen weeks or longer pregnancies, by medically inducing a spontaneous abortion (for example by using a hypertonic saline agent plus labor-stimulating agents). One way of performing such an abortion that is now widely used is through the use of a vacuum device. In such a vacuum device using differently sized cannulas, each cannula essentially has a cross-sectional dimension in the range of 10 to 14 mm at the cannula end or suction region which penetrates the uterus. Before the actual abortion process begins, the uterine cervix must be substantially dilated so that the cannula or the suction tip of the vacuum device can be inserted into the uterus. The particular size of the cervical cervix and the required expansion ^{in order to be able to introduce a suitably dimensioned vacuum void / IcIIt 1} UiJ ₀ into the uterus and to evacuate it depends on the state of pregnancy. The shorter the pregnancy, the smaller the amount of uterine expansion that is required before the abortion is carried out.

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Pregnancies of 17 weeks or more require stimulation in addition to significant dilatation of the lower uterine section, making it more effective Abortion occurs. Stimulation of the lower uterine section is desirable in order to provide a spontaneous To allow abortion to occur and to expel most of the product of conception naturally; Dan alas, the remains of conception remaining in the uterus can relatively easily removed by scraping the abortion or by ordinary enlargement and removal will. The abortion at a 17 week old or later Pregnancy is usually made transabdominal by the introduction of a hypertonic saline agent to stimulate a spontaneous abortion "initiated so that most of the pregnancy products are removed, followed by conventional D&C.

As mentioned before, "is currently widely accepted technique for cervical extension before the introduction of the vacuum mechanism for performing the abortion is that you _/ the oak during pregnancy v /, fleshy consistency v / eist in Gebäjftrmutterhals metallic dilators introduced The use of such metallic dilators is undesirable for a number of reasons, inter alia, because a more or less extensive tearing of the cervix can occur, which is associated with pain Occasionally, the more serious case that the uterus is pierced can occur. Such uterine perforations can lead to injury to the intestines or an accidental hystere-tomia. In addition, injury to the cervix of the uterus can occur during the operation use

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dangerous bleeding caused by metallic dilators and further health-endangering effects cause later pregnancies of the patient.

The device according to the invention and the related Processes create a gradual, controlled, uniform expansion of the pastry neck. The invention Device allows because of its design and the use of medically acceptable, flexible, smooth Materials an injury-free expansion without damaging the neck of the building. The atraumatic process of the Procedure can be strong to a substantial degree without sacrificing safety and comfort for the patient Avoid numbing the cervical area, such as by widening the cervical neck with metallic ones Dilators was previously required because of the pain and discomfort associated with them.

In addition, the method and apparatus of the invention provide by introducing a foreign body into the Uterus and subsequent interruption of pregnancy by expanding the anchoring element 44. the high ! • Probability of spontaneous abortion and the doctor only needs to remove small remnants of the pregnancy.

It is also during the expansion of the uterine neck Occasionally desirable a drainage of liquid from the uterine cavity. Conversely, it is sometimes desirable to have a medicinal agent in the uterine cavity such as rivanol. Both are possible with the aid of the device according to the invention feasible.

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The procedure according to the invention is as follows: introduction of a foreign body into the uterus and gradual and uniform widening of an otherwise unexpanded neck of the cervix before the abortion is carried out, this widening by gradually and uniformly mechanical expansion of the neck of the cervix in the radial direction and leaving it in place of the foreign body after the uterine cervix is fully expanded in utero over a period of up to about 24 hours. The expandable expansion member is expanded uniformly and gradually in a radial direction for a period of time up to about 4 hours, maintaining substantially a generally uniform cross-sectional dimension along its entire length, and thus substantially the entire length of the neck of the appliance. The exact extent of the expansion of the expansion element is determined by the doctor and can according to the needs. characteristics of the patient can be varied until the. The neck of the uterus is expanded to the "maximum required amount. It should be noted that the amount of expansion of the neck of the uterus is changed depending on the pregnancy.

In the process according to the invention, the doctor or other Medically skilled people insert the abortion relief device the evening before the day of the abortion is carried out. It can also be introduced on the same day will'. If this is done the previous evening, the anchoring element 44 is immediately, for example expanded within a minute or two and the expansion element 46 gradually expanded over a period of up to extended to four hours / and the device remains in the fully expanded state overnight in place,

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If the abortion did not occur spontaneously the next morning the unit is removed and the abortion is completed. If the device according to the invention is on Inserted on the day of the abortion, the anchoring element 44 and the expansion element are rapidly inflated 46 is gradually expanded over a period of up to four hours. After that, the abortion Leave the relieving unit in place for a few hours before removing and inducing a spontaneous abortion be, or else it will be complete immediately after Expansion removed to perform the abortion. When a spontaneous abortion occurs, and this is a very the only desirable result remaining is the use of vacuum scraping or evacuation and scraping to clean the uterus of any remaining products of conception. It should be noted that the introduction of the abortion-relieving body according to the invention in a medical practice or clinic can be done, and the patient overnight with the fully expanded body in place can be sent home. The next morning the patient is asked to remove the body and finish return of the abortion. ·

If the abortion is to be performed around six weeks of pregnancy, it is generally advisable make the cervical widening to at least about 10 mm. Therefore, in case of abortions during the first six weeks of pregnancy the length of the expansion element 46 will be about 5 cm while its inflated average should be slightly larger than about 10 mm unc-i Preferably can be expanded up to about 15 mm. With a unit that used during the first six weeks of full-term pregnancy

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is to be, the anchoring element 44 should have a diameter of about 1.5 cm when inflated and a Have a length of about 1 cm.

For pregnancies of more than six weeks up to about twelve weeks, a cervical dilation of at least about 12 mm is desirable and accordingly the dilation element for a device that is used in persons in this state of pregnancy should have an inflated diameter of at least about 12 mm and preferably be expandable up to a diameter of about 150 mm, whereby it should have a length of about 6 cm. In such a unit, the anchoring member 44 would have an inflated diameter of at least about 12 mm and preferably be inflatable to J> Q mm; its length should be about 1 cm.

The dilator element for use in women who are more than about 12 weeks pregnant would include an inflator Have a diameter of at least about 14 mm and preferably up to about 40 mm and a length of 6 cm, so that one. Expansion ... of .at least "about 14 mm is possible is. The anchoring element 44 would correspondingly have an expanded diameter of at least about 14 mm and preferably up to about 40 mm and a length of 1 cm.

It should be noted that the expandable element 46 is preferably designed so that it is significantly above the minimum amount required to perform the abortion can be expanded. This is recommended insofar as to a maximum adaptability for the invention Device to create and maximum expansion to be provided for a slight abortion.

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Accordingly, there are three different sizes of the invention Unit capable of introducing the varying amounts of cervical dilatation currently in use Great for the cannulas or suction tips for suction scraping during the various states of pregnancy meet. Pure in the event, however, that a more limited one and controlled expansion is desired, the units can also have smaller dimensional differences are executed. Furthermore, since the dimensions and circumstances of a patient can be different, it can be expedient or necessary to use a smaller or larger unit than usual and further ' it should be noted that the dimensions of the abortion-relieving unit described here and the extent of the Details that should be applied to patients in various states of pregnancy are general only Present point recommendations.

As soon as the desired degree of widening is achieved, the widening element K6 and the anchoring element hk are folded together to their original dimensions and the body is removed from the patient so that the rest of the abortion procedure can take place.

More specifically, to carry out the invention according to the procedure the examining doctor or other medical trained staff examine the patient to determine her circumstances and the size of the pregnant uterus determine so that an appropriate size of the abortion facilitating device can be selected. Further The doctor will determine whether the present uterus is displaced forwards or backwards acts. Then a non-painful tenacle can temporarily work on the. look like mouth of the mother

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haises are attached to make them immobile, and an antiseptic is applied to the cervix during visual observation of the cervix through a speculum fed.

Using sterile gloves and maintaining a sterile environment, the device according to the invention of a suitable size is then removed from its sterile sheath 60 and a small amount of KY jellies is placed on the distal end 12 It is ironic that at this point in time both the anchoring element 44 and the extension element 46 are in the folded-up state. The anchoring element 50 determines the approximate maximum amount up to which the distal region of the expansion element of the device according to the invention can be inserted into the uterine cervix and usually the anchoring element 50 will be about 1 cm from the front end of the building cervix. At this point, the collapsed expansion element 46 sits within the cervical canal or cervix and the proximal end 20 of the catheter 10 and the lines 14-, 16 and 18 extend substantially out of the patient's vagina so that a simple connection to suitable, Fluid introducing devices can be made. At this point, also the distal end of the unit confining · lent extends the Veraxikerungselementes 44 into the uterus, the manner shown in Fig. 6 -According (except that _/ neither the member 44 nor the members are inflated 46), and forming a destructive Foreign bodies in the uterus,

For initially securing the unit 8 in place it may be desirable to have a few seams on the cervix and to attach the wings 50. The openings 54

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in the wings 50 allow the doctor to go through each Passing opening a tenacle and on. this way that Pastry neck from both sides for possible carbonated injections to take.

The anchoring element 44 and the expansion element 46 are then to their appropriate maximum sizes, the ranging from 1.5 to 4 cm, depending on the particular dimension of the unit used, inflated. This expansion can be achieved by introducing an appropriate amount of sterile Water can be made in the lines 14 and 16, respectively. The water can be poured through a syringe with a suitable Luer lock connector, for example, if a luer lock connection is introduced as part of the abortion facilitating organ is packaged according to the invention. The liquid is rapid and complete via line 14 Inflating the body 44 is inserted and the line 16 is then connected to a Harvard infusion pump, not shown with a Luer lock or another suitable one Connection connected to supply a controlled amount of fluid in a controlled and gradual manner Introduce expansion of the element 46. If removable closure members are used at the ends of the lines 14 and 16 a syringe needle can be used to introduce the appropriate amount of liquid.

For an anchoring element with an inflated diameter of 1.5 cm, approximately three quarters of sterile water is required for proper expansion. In the case of an expansion element in which the expanded diameter of the anchoring element is 44 J cm, approximately 5 cirr V / water are required and the anchoring element, which reaches a diameter of 4 cm when inflated, requires approximately 10 cwr

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Water to a clean expansion. The anchoring elements are usually quickly removed within about one or more hours inflated two minutes. It should be noted, however, that the exact timing and degree of fluid introduction is quite variable and on the judgment of the doctor or other medically trained staff to achieve optimal conditions for the respective patient depends.

The amount of liquid required to expand the expansion element 46 depends on the size of the expansion element. With an expansion element 46 having a diameter of 1.5 cm and a length of 5 cm when inflated, approximately 12 cm sterile water or some other fluid will be required for a clean expansion. With an expansion element 46, which in the expanded state has a diameter of about 5 cm and a length of about 6 cm, about 30 cm of sterile water and with an expansion element 46 with a diameter of about 4 cm and a Length of about 6 cm in the expanded state, about 60 cm sterile water may be required for a clean expansion. When expanding the expansion element 46, it may initially be desirable to enter 10 to 20% of the filling capacity of the expansion element, since the fluid introduction can be temporarily interrupted at any point in time if the patient experiences any significant pain or discomfort. The remaining fluid may then be introduced at a rate of approximately 10 % of the filling capacity of the expansion element 46 over a period of half an hour. It goes without saying, however, that the exact timing and filling rate of the fluid is very variable and depends on the judgment of the doctor or other medically trained personnel,

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depends on the optimal conditions for each patient.

It should be noted that the anchoring element 44 should preferably be expanded relatively quickly before the expansion of the expansion element 46 begins.

The length of time that the expansion takes place depends of course, on the amount of expansion to be achieved, and the expansion becomes highly desirable over a period of time gradually made about 4 hours. The widening of the neck of the building can also be much less than four hours to complete, however, proceeding too quickly can cause pain for the patient, like this that an essential advantage of the procedure according to the invention would be lost. The precise timing and fill rate is best determined by the attending physician, but it is very desirable that the patient be informed about the situation Bucket is done at a relatively uniform rate for best results with minimal time and minimal annoyance to the patient.

As soon as the device according to the invention is localized in place within the uterus, any blood within the uterine cavity can be drained to the outside through the openings J> 0 and the channel 28 and through the line 18. A suitable syringe can also be connected to line 18 for removal of blood or other fluid. Similarly, if it is desirable to introduce a drug into the uterine cavity, such as a Rivanol solution, it can be introduced through a syringe conveniently connected to the proximal end 58 of the line 18.

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As soon as the expansion is completed, the Liquid in anchoring element 44 in the same way as with the original introduction by means of an appropriate syringe and any, the anchoring element 50 with the building nut neck Seams cut through and removed.

At this point in time, it is necessary to expand the expansion element 46 liquid used by means of a syringe connected to the proximal end 36 of the line 16 or pump away, and as a result, folds the expansion element 46 in the state shown in FIG. 1. At this point in time it is the easing of the abortion Unit 8 prepared to be easily removed by the doctor, with the neck of the breast expanded to the desired extent and the abortion can expire.

It should be noted that, although sterile water the preferred means for expanding the anchoring element 44 and the expanding element 46 is other sterile, medically acceptable fluids such as either pressurized gases or liquids can be used.

From the foregoing it is therefore clear that the device and the method of the invention provides a convenient, safe, and effective method of induction and relief of abortion! and to safely perform a cervical Represent widening, this device being the drainage of fluids in the uterus and the input of drugs before -Performing the abortions permitted.

It goes without saying that although special materials, shape

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Conditions and dimensions of the device and the procedure according to the invention have been described, certain Changes in materials, shape and the dimensions as well as the procedures can be carried out without deviating from the essence of the invention »

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Claims (7)

Claims Device for widening the neck of the building for making an abortion by an elongated, rigid, flexible, tubular Body with a proximal and a distal End forming at least two conduits beginning near the proximal end; an expandable, circumferential expansion element, which is an integral Is part of the tubular body and has a length in the range of about 5 cm to about 6 cm, the Elemept a cross-sectional dimension in the unexpanded Has a state of approximately the same size as the cross-sectional dimension of the tubular body, while in the expanded state there is a cross-section erosion is in the range of about 1.5 cm to about 4 cm and the element is substantially in the shape of a cylinder occupies with rounded ends in the expanded state; an expandable, circumferential anchoring element as integral part of the tubular body which is spaced on the distal side of the expansion element is formed by this and in the fully expanded state has a cross-sectional dimension, approximately polygamy equal to that of the expansion element in the expanded State Jst ^ and which are further characterized by that one of the two lines with the interior of the expansion element and the other line with the interior of the anchoring element are in connection. - 27 ■■ -309843 / 0547 2. Device according to claim 1, characterized in that that the tubular body forms a third conduit extending from a point near the proximal end of the tubular body to a Location near the distal end thereof, where the third conduit communicates with the surface of the unit near the distal end thereof, whereby fluid can be diverted from the uterus or introduced into the uterus through the third conduit. 3>. Device according to claim 1, characterized in that close to the tubular body and at a distance from the proximal end of the expansion element a stop element is formed which extends transversely to the device and at least has an opening extending axially through the stop member so that an attachment of the element is possible in situ. 4. Apparatus according to claim 1, characterized in that that the tubular body has a rounded distal end, while the proximal End ends in three separate, spaced lines. 5. The device according to claim 1, characterized in that the tubular body consists of a sterilizable, smooth material is. 6. The device according to claim 1, characterized in that the proximal end of each the two lines are closed by a removable membrane. 309843/0547 - 28 - 7. The device according to claim 1, characterized in that the anchoring element is a proximal end and the expansion element has a distal end, the distance between the ends ranges from about 1 cm to about 2 cm .. 30 9843/054 ft * Blank page