Abortion Facilitating Device And Process

Abstract

A process for cervical dilation prior to the performance of an abortion comprising the steps of inserting an abortion facilitator unit through the cervix and extending into the uterine cavity, gradually, uniformly radially expanding the portion of the dilator adjacent to the cervix at a controlled rate to dilate the cervix by introduction of a fluid, removing the fluid once the cervix has been dilated, removing the dilating unit, and completing the abortion. Apparatus for cervical dilation comprising a shaft member having three conduits extending therethrough, one conduit terminating substantially inboard the distal end and communicating with a dilating section of substantially cylindrical configuration when expanded, a second conduit terminating distal of said first conduit and terminating in an expandable anchoring member, and said third conduit terminating proximate the tip of said shaft member for permitting ingress and egress of fluids to the uterine cavity.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a cervical dilating apparatus and process for performing an abortion which has the effects of dilating the cervix and facilitating, and, on some occasions, spontaneously initiating an abortion.

2. State of the Art

Although cervical dilators have been suggested for use in dilating the cervix to facilitate labor during full-term birth, as disclosed in U.S. Pat. 3,480,017, satisfactory techniques and apparatus for dilating the cervix atraumatically prior to performing an abortion have not been developed, and no apparatus or process has been disclosed for generally facilitating and, on some occasions, spontaneously inducing an abortion.

In performing abortions by the technique in which dilation of the cervix is necessary to permit introduction of a vacuum device to accomplish the abortion, dilation of the cervix was previously accomplished by the use of steel dilators, which were manipulated in such a way as to stretch and stimulate the cervix to cause it relatively rapidly to dilate to the necessary degree to permit the abortion. The extent to which cervical dilation is required depends upon the stage of the pregnancy, ranging from approximately 10 mm. for a pregnancy at approximately the fifth or sixth week of its progress to approximately 14 mm. for a pregnancy which is in the third or fourth month of its progress. This manipulation of the cervix with steel dilators could, and frequently does, cause tearing and laceration of the cervix, occasionally resulting in severe lacerations of the cervix, often needed to be closed by suturing, and also could and occasionally does result in the much more serious incident of the perforation of the uterus.

Moreover, prior to this invention, there has been no apparatus or process known for use in inducing abortions in advanced pregnancies, on the order of 17 weeks, to accelerate the period after injection of hypertonic saline and prior to miscarriage and sometimes to induce miscarriage without the injection of hypertonic saline.

BRIEF SUMMARY OF THE INVENTION

The process of the invention comprises the insertion of the dilation device of the invention into and through the cervix, so that the distal end thereto extends into the lower segment of the uterine cavity, expansion of an anchoring member by introduction of fluid thereinto, to prevent accidental dislodging of the dilation device, and uniform and gradual radial expansion of the dilating member which occupies the entire length of the cervix, up to a transverse dimension of between about 1.5 cm. and 4 cm. or more, depending upon the stage of the pregnancy of the patient being treated. When the maximum desired degree of dilation has been achieved, which will desirably be achieved in four or more hours, the abortion facilitator may be allowed to reside in place for a substantial period of time, preferably overnight. When it is time to complete the abortion, if it has not occurred spontaneously, the dilating member is deflated to its normal dimension which is almost the same as the transverse dimension of the shaft member body per se, the anchor member is also deflated to its normal dimension, and the abortion facilitating device is removed. During the presence of the dilating device in situ, fluid can be removed from the uterine cavity or introduced thereinto through a conduit which communicates the proximal end of the shaft member, which extends outside the patient's vagina during the dilation procedure with the distal end thereof which is located within the patient's uterus.

During the residence in utero of the abortion facilitator device of this invention, the "pregnancy" is disrupted by the distal segment of the device and by the expansion of the anchoring member, and this tends to stimulate a spontaneous abortion due to the presence of a foreign body in the uterus.

The abortion facilitator apparatus of the invention comprises a thin, elongated shaft member, having a rounded distal end and a proximal end which preferably terminates in three separate conduits, each of which communicates with a distinct channel defined within the shaft member per se. One channel communicates with the dilating member of the shaft member, which is spaced a substantial distance from the distal end of the shaft member. The dilating member, in the deflated state, is of substantially the same dimensions and cross-section as the shaft member body per se, and in the inflated state is of substantially cylindrical shape and has a transverse dimension of from about 1.5 cm. to about 4 cm., and a length of from about 5 cm. to about 6 cm. In the expanded condition and in the expanding condition, the dilating member maintains the substantially cylindrical configuration, with rounded ends, so that, as it expands, the dilating member applies uniform pressure to the cervical os which surrounds it.

Spaced distally of the dilation member, a distance of about 1 cm. to about 1.5 cm., is an anchoring member, which extends into the uterus, and prior to inflation is of the same transverse dimension as the shaft member body per se. The anchoring member, as it is inserted in the uterus acts as a foreign body (with the tip of the abortion facilitator) and as it expands will disrupt the pregnancy, thereby stimulating the uterus to expel the foreign body and, on some occasions, to induce a spontaneous abortion. The anchoring member is supplied with fluid from a separate conduit formed in the shaft member body, and expands to a transverse dimension approximately equal to the expanded transverse dimension of the dilating member. It is inflated, in use, prior to inflation of the dilating member, and serves to anchor the cervical dilator unit in situ. In its expanded condition the diameter of the anchoring member is approximately equal to the diameter of the dilating member. Therefore, if spontaneous abortion occurs, the anchoring member will not interfere with the natural expulsion of the abortion facilitator, since its diameter will be equal to the dilated opening of the cervix.

Spaced from and proximate the proximal end of the dilating member is a pair of wings, extending transversely in the body of the shaft member, and having an aperture in each of the wings. The wings function to assist in the location of the shaft member with the cervical dilating member properly located within the cervix, and the apertures in the wings facilitate temporary suturing of the shaft member in place, and allow passage of a tenaculum through the opening in each wing.

The proximal end of the shaft member terminates in three distinct conduits, one for supplying an inflating fluid to each of the respective dilating and anchoring members, and one leading to a main channel which is internal to the body of the shaft member and extends therethrough to a point proximate the rounded tip at the distal end thereof. This latter channel permits drainage of fluid from the uterus and the introduction of medication into the uterus. Each of the two conduits leading to the respective anchoring and dilating members may be equipped, and preferably is equipped at its proximal end with a suitable valve device, to permit the attachment of a member or means for introducing fluid to the two expandable member conduits. The conduit connecting to the main channel, for introducing to or removing fluid from the uterus is preferably left open, and fluid or medication can be introduced into the uterine cavity by an irrigating-aspirating syringe, for example.

In the preferred form of the invention, the abortion facilitating device of the invention is produced in a number of different sizes, having somewhat different dimensions for use with women in different stages of pregnancy. Each abortion facilitator unit is preferably formed of a medically acceptable, firm but flexible material, and is also preferably packaged in a sterile package for one-time use and disposal.

OBJECTS OF THE INVENTION

It is therefore an object of this invention to provide a process for the atraumatic and relatively safe dilation of the cervix of a patient as a preliminary step to the performance of an abortion and including the insertion of a foreign body into the uterus to tend to stimulate spontaneous abortion.

Another object of this invention is to provide a process for the pre-abortion dilation of the cervix by slowly and gradually, at a controlled rate, expanding the walls of the cervix under the pressure of the dilating member of the invention.

Yet another object of the invention is to provide a dilating apparatus, for use prior to an abortion procedure, and comprising a dilating member for uniformly radially gradually dilating the cervix, relatively painlessly and without damaging the cervix or the uterus.

A concomitant object of this invention is to provide a cervical dilating apparatus including means obtruding into the cervix to act as a foreign body, to disrupt the pregnancy and to anchor the abortion facilitating apparatus in place during use, to prevent inadvertent displacement thereof during use, and further including means for facilitating drainage of liquid from the uterus and introduction of liquid into the uterus.

An attendant object of this invention is to provide a cervical dilation apparatus which can be produced in different sizes, for optimal use in performing abortions in persons at different stages of pregnancy.

A still further object of this invention is to provide an apparatus which may easily be inserted into the cervical os and uterine cavity atraumatically and with a minimum of discomfort and pain to the patient.

A still further object of this invention is to provide an apparatus for cervical dilation that will also stimulate the lower uterine segment and make the uterus more responsive to oxytocics, thereby inducing rapid miscarriage in pregnancies of 17 weeks and greater duration, and on occasion in such late pregnancies stimulate spontaneous abortion without the need of oxytocics.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary front elevational view of the apparatus of this invention, packaged in a sterile package prior to use;

FIG. 2 is a fragmentary front elevational view of the apparatus of this invention, in the fully expanded condition;

FIG. 3 is a cross-sectional view taken along line 3--3 of FIG. 2;

FIG. 4 is a cross-sectional view taken along line 4--4 of FIG. 2;

FIG. 5 is a cross-sectional view taken along line 5--5 of FIG. 2; and

FIG. 6 is a schematic representation of a uterus showing the operative end of the apparatus of the invention in place in the expanded condition.

DETAILED DESCRIPTION OF THE INVENTION

Viewing FIG. 2, the abortion facilitator unit of this invention, generally designated by the numeral 8, is seen to comprise a shaft member, generally designated as 10, having an elongated body, formed of medically acceptable, sterilizable, firm, flexible material, more fully described hereinafter, and terminating at its distal end in a rounded tip 12 and at its proximal end in three discrete conduits, respectively designated 14, 16 and 18. The conduits 14, 16 and 18 are integrally formed with and connected to the shaft member member 10 at its proximal end 20. The shaft member member 10, between its proximal end 20 and extending toward its distal end 12, defines three discrete channels, respectively designated 24, 26 and 28, best seen in FIG. 4. The longest channel, channel 28, extends from the proximal end of the shaft member, where it is in fluid communication with conduit 18, to a point spaced proximate the distal end 12 of the shaft member where channel 28 communicates with a plurality of apertures 30 which extend to the surface of the shaft member 12, and which permit fluid flow from the ambient at the distal end of the shaft member, into channel 28 and therefrom into conduit 18, and exiting through the proximal end 38 of conduit 18.

It may be desired, to avoid any confusion, to label each of the conduits 14, 16 and 18 with some identifying language indicating the particular communication which each provides, such as by labelling conduit 14 "anchor," conduit 16 "dilator," and conduit 18 "uterine."

Channel 24 extends to a point spaced inwardly from the distal end 12 of the catheter and is in fluid communication, via a transverse channel 34, seen in FIG. 3, wth the inflatable anchor section or member 44 of the catheter. Anchor section 44 is shown in the deflated condition in FIG. 1 and in the inflated condition in FIGS. 2 and 6. Anchor member 44 comprises a thin, expandable, peripheral membrane, like a balloon, formed at the outer surface of shaft member member 10, and having substantially the same cross-sectional size and configuration as the remainder of the body of the catheter 12 when in the deflated condition shown in FIG. 1. Upon introduction of fluid, through conduit 14, into channel 24, and through channel 34 to anchor member 44, the anchor member 44 is inflated to the squat toroidal configuration shown in FIG. 2, in which the anchor member 44 preferably has a maximum diameter in the range from about 1.5 to about 4 cm., approximately equal to the inflated diameter of the dilating member 46; different sizes of abortion facilitators will have different maximum diameters, depending upon the stage of pregnancy for which the device of this invention is to be used.

Also formed at the outer periphery of the shaft member body 10, is an inflatable dilating member 46. Dilating member 46 comprises a thin, expandable peripheral membrane, like a balloon, which, when in the deflated condition shown in FIG. 1, has a cross-section approximately equal to the cross-section of the shaft member body, and, when in the inflated condition, has the substantially cylindrical shape, with rounded ends, illustrated in FIG. 2. The dilating member 46 is in fluid communication with channel 26, through a transverse channel 36 in the body of the shaft member 10, to allow the dilating member to be inflated, by the introduction of fluid through conduit 16, into channel 26, and therefrom through transverse channel 36 into the dilating member 46. The upper end of dilating member 46 is spaced below the lower end of anchor member 44 a distance of about 1.0 cm. to about 1.5 cm., for purposes more fully to be described hereinafter.

The dimensions of dilating member 46 may be varied, in accordance with the stage of pregnancy of the patient whose cervix is being dilated, and the dimensional differences will also be more fully described hereinafter. However, in one embodiment of the invention, usable for patients during the sixth to twelfth week of pregnancy, the dilating member 46, in the expanded condition, will have a diameter of approximately 3 cm. and a longitudinal dimension of approximately 6 cm. The construction of the dilating member 46 is such that the longitudinal portions of the outer wall 48 of the dilating member are approximately parallel, and remain approximately parallel as the dilating member expands from the deflated condition of FIG. 1 to the inflated condition of FIG. 2.

Formed inboard the proximal end of dilating member 46, and spaced about 1 cm. therefrom, is a second anchor member 50, which is best seen in FIG. 5 to comprise two loop sections 52 formed on opposite sides of the shaft member body 10, each of the loops defining a central aperture 54. The function of the anchor member 50 is to assist in anchoring the shaft member in place, as will be more fully described hereinafter.

The distal end 12 of the unit has a rounded tip of approximately 0.5 cm. length, and the distance from the tip to the distal end of anchor member 44 is approximately 2.0 cm. to 3.5 cm.

The distance from the proximal end of anchor member 50 to the proximal end of conduit 18 is, in the preferred embodiment of the invention, about 30 cm. to about 32 cm.

The diameter of shaft member 10 is preferably in the range from about 5 mm. to about 7 mm. The anchor members 50 are approximately 3 mm. in their longitudinal dimension.

The abortion facilitating device of the invention is formed of a medically acceptable, sterilizable, non-toxic, non-irritating material, of a type which is well-known in the art, such as latex, rubber, silicone rubber, or Silastic, a silicone elastomer. It may be desirable, depending upon the particular rigidity of the material of which the shaft member is constructed, to mold a scrim of Dacron or similar material into the material of the shaft member, in a well-known manner, to give it greater rigidity, and thereby make it more convenient to handle. The abortion facilitator of this invention is preferably molded of a unitary body of material, in a manner which is known in the art, although it is within the purview of this invention to mold elements separately and bond them together utilizing adhesives, plasticizers or other well-known techniques or means.

It may also be desirable to incorporate a reinforcing scrim of Dacron or similar material into the wall 48 of dilating member 46, in order to insure that the dimensional integrity of the dilating member is maintained, in substantially cylindrical form, as the dilating member is expanded against the walls of the cervix, in the manner described hereinafter.

As shown in FIG. 1, the abortion facilitator device of the invention is packaged in a closed, hermetically sealed envelope 60, of a type which is well-known in the art, and which is sterilized within the envelope, such as by initially evacuating the envelope with the abortion facilitator device inside, and replacing the interior of the envelope with a sterilizing medium such as ethylene oxide, and subsequently evacuating and sealing the envelope. This would insure the sterility of the unit prior to its use.

In manufacturing the cervical dilator device of this invention, the respective terminal ends 34 and 36 of conduits 14 and 16 may be formed, in a manner which is well-known in the art, with a resealable membrane of rubber, latex, or the like, to permit the maintenance of the sterility of the interior of conduits 14 and 16 and channels 24 and 26 when the dilating unit is located in situ. Alternatively, each of the conduits or one or more of the conduits could be packaged with a Luer lock adapter inserted therein, to permit connecting of the respective conduits to suitable syringes or other devices for the introduction of fluids, having mating Luer lock members, in a manner which is well-known in the art.

The abortion facilitator device of this invention, and the process of its use of this invention, are utilized in connection with the performance of an abortion, which is usually performed by dilatation and curettage, or, in the case of pregnancies of 17 weeks or greater duration, the medicated inducement of spontaneous abortion (as by the use of hypertonic saline plus oxytocics). One currently popular way for performing such an abortion is by the use of a vacuum device. Such a vacuum device, using different-sized cannulae, each of which has a substantial cross-sectional dimension, on the order of 10 to 14 mm. of the cannula or suction tip portion which enters the uterus. A substantial amount of cervical dilation is necessary, prior to undertaking the actual abortion procedure, in order to allow the cannula or suction tip of the vacuum device to be inserted in the uterus. The particular size of the cervix, and the amount of dilation necessary in order to allow a properly sized vacuum device to enter the uterus and evacuate the uterus will depend upon the stage of the pregnancy. The earlier the pregnancy, the less the amount of dilatation of the uterus which is necessary prior to performing the abortion.

Also, pregnancies which are at or beyond the 17 week stage, require, in addition to substantial dilatation, a stimulation of the lower uterine segment, in order to have an effective abortion. The stimulation of the lower uterine segment is desirable in order to cause spontaneous abortion to occur and expel naturally most of the products of conception; then the remaining products of conception in the uterus may be removed relatively easily by abortion curettage or the usual dilatation and curettage procedure. The commencement of abortion at the 17 week or later stage is usually commenced by the introduction trans-abdominally of hypertonic saline to stimulate spontaneous abortion to remove most of the products of conception, after which a conventional D & C is performed.

As previously noted, the currently accepted technique for cervical dilation prior to vacuum mechanism insertion to perform abortion, is by inserting into the cervix, which has a soft and pulpy consistency during pregnancy, metal dilators which are used to dilate and stretch the cervix to the dilated condition. The use of such metal dilators is undesirable for a number of reasons, including the likelihood that minor or even major lacerations of the cervix could occur, causing pain and requiring suturing, and occasionally the more disastrous possibility of a uterine perforation can occur. Such uterine perforations can result in bowel injury or an accidental hysterectomy. Also, traumatizing the cervix by the use of metal dilators may cause dangerous hemorrhaging and also may have deleterious effects on later pregnancies of the patient.

The apparatus and process of the instant invention provide for the gradual, controlled, uniform dilation of the cervix by the device of the invention which, because of the construction of the device and because it is formed of medically acceptable, flexible smooth materials, permits atraumatic dilatation to be achieved without damage to the cervix. The atraumatic nature of the process, without sacrificing safety or comfort of the patient, can avoid, to a substantial extent, the necessity for heavily anesthetizing the cervical area, which is otherwise necessary because of the pain and discomfort attendant upon dilatation of the cervix using metal dilators.

Moreover, the process and apparatus of this invention, by introducing a foreign body into the uterus and further disturbing the pregnancy by the expansion of anchoring device 44, create a reasonable prospect that spontaneous abortion will occur, leaving only a minor removal of residual pregnancy to be done by the medical professional.

It is also desirable, during the dilation of the cervix, on occasion, to permit drainage of fluid from the uterine cavity, and it is sometimes desirable to be able to introduce medication into the uterine cavity, such as Rivanol both of which desiderata are provided by the apparatus of this invention.

The process of this invention comprises the introduction of a foreign body into the uterus and gradual and uniform dilation of an otherwise undilated cervix, prior to the performing of an abortion, by gradually and radially uniformly mechanically expanding the cervix, and, after the cervix is fully dilated, allowing the foreign body to remain in utero for a period of up to about 24 hours. The expandable dilating member is uniformly and gradually radially expanded during a period of up to about four hours, while maintaining substantially along its entire length, and therefore substantially along the entire length of the cervix, a generally uniform cross-sectional dimension. The precise rate of expansion of the dilating member will be determined by the physician or medical professional, and may be varied as indicated by experience with the patient, until the cervix is dilated to the maximum necessary extent. It is to be appreciated that the extent of dilation of the cervix will vary in accordance with the duration of the pregnancy of the patient being aborted.

In the process of this invention the physician or other medical professional could either insert the abortion facilitator device on the evening before the day on which the abortion is to be performed, or on the day the abortion is to be performed. If done the previous evening, anchor 44 is promptly fully dilated, such as within a one or two minute period, and dilator member 46 will be expanded gradually during a period of up to about four hours and the device, in fully expanded condition, is allowed to remain in place overnight. The next morning, if abortion has not occurred spontaneously, the abortion facilitator may be removed and the abortion completed. If the abortion facilitator device is inserted on the day of the abortion, it would be inserted, the anchor 44 would be inflated quickly, and the dilating member 46 would be expanded gradually during a period of up to about 4 hours. Thereafter, the abortion facilitator may be permitted to remain in place for several hours before removal to attempt to initiate a spontaneous abortion, or it may be removed promptly after it is fully expanded to perform the abortion. If spontaneous abortion does occur, and this is a very desirable result, then all which remains to be done is to use vacuum curettage or evacuation and curettage to remove from the uterus the remaining products of conception. It is notable that the insertion of the abortion facilitating member of the invention may be done at a doctor's office or clinic and the patient could be sent home overnight with the abortion facilitating member in place in the fully expanded condition. The patient would return the next morning for removal of the abortion facilitating member and completion of the abortion.

Generally, if the abortion is being performed during about the sixth week of the pregnancy, the amount of cervical dilation desired is at least about 10 mm. Therefore, for performing abortions during the first 6 weeks of pregnancy, the length of the dilating member 46 would be about 5 cm., and its inflated diameter would be about somewhat greater than 10 mm. and would preferably be expandable up to about 15 mm. In a unit intended to be used during the first 6 weeks of pregnancy, the anchoring member 44 would have a diameter of about 1.5 cm. in the inflated condition and a length of about 1 cm.

For women having pregnancies of more than about 6 weeks and up to about 12 weeks duration, at least about 12 mm. of cervical dilation is desired, and, accordingly, the dilating member of a device intended to be used with a person in this stage of pregnancy would have an inflated diameter of at least about 12 mm. and would preferably be expandable up to a diameter of about 30 mm. and would also have a length of approximately 6 cm. In such a unit, the anchoring member 44 would have an inflated diameter of at least about 12 mm. and preferably up to about 30 mm. and a length of about 1 cm.

The dilating member for use with women having pregnancy of a duration of more than about 12 weeks, would have an expanded diameter of at least about 14 mm. and preferably up to about 40 mm. for the dilating member 46, which would also have a length of 6 cm., to achieve dilatation of at least about 14 mm., and the anchoring member 44 would correspondingly haVe an expanded diameter of at least about 14 mm. and preferably up to about 40 mm. and would have a length of 1 cm.

It is to be noted that the expandable member 46 is preferably designed to be expanded substantially in excess of the minimum degree of cervical dilatation necessary to perform the abortion. This design preference is recommended in order to permit maximum flexibility in the use of the inventive device and to provide maximum dilatation for ease of abortion.

Accordingly, 3 different sizes of abortion facilitator units would reasonably be able to accommodate the different degrees of cervical dilatation desired for insertion of the currently used sizes of cannulae or suction tips for suction curettage during different stages of pregnancies. Of course, in the event that more limited and controlled amounts of expansion are desired, units can be made having smaller increments of difference of dimensions. Also, since the dimensions and conditions of a patient may vary, it may be necessary or desirable to use a smaller or larger unit than usual with a particular person, and it is to be noted that the dimensions of the abortion facilitator unit to be used as described herein and the extent of dilatation to be achieved with patients with different stages of pregnancies are general recommendations only.

Once the desired degree of dilatation is achieved, the dilating member 46 and anchor member 44 are deflated to their original sizes, and the abortion facilitator member is removed from the patient to permit the remainder of the abortion procedure to take place.

More specifically, in the performance of the process of the invention, the examining physician or other medical professional would examine the patient to determine the condition of the patient and the size of the pregnant uterus, so that the appropriate size of abortion facilitating device would be selected. The physician or other medical professional would also determine whether the uterus is anteverted or retroverted. When this is determined, a non-traumatizing tenaculum could be attached temporarily to the anterior lip of the cervix in order to steady it, and an antiseptic applied to the cervix, this being done while visualizing the cervix through a speculum.

Using sterile gloves and maintaining a sterile set-up, the abortion facilitating device 8 of this invention of appropriate size, is then removed from its sterile envelope 60, and a small amount of KY jelly is applied to the distal end 12 thereof. The abortion facilitating device 8 would then be slid into the uterus, it being appreciated that, at this point in the process, both anchor member 44 and dilating member 46 are in the deflated condition. Anchor member 50 determines the approximate maximum degree to which the distal portion of the dilating member of the abortion facilitator device of the invention can be inserted in the cervix, and, in the usual position, the anchor member 50 would be spaced approximately 1 cm. from the anterior end of the cervix. At this point, the deflated dilating member 46 is seated within the cervical canal or cervical os and the proximal end 20 of shaft member 10 and conduits 14, 16 and 18 extend substantially without the patient's vagina, for easy connection to suitable fluid introduction devices. At this point also, the distal end of the abortion facilitator unit, including anchor member 44, extend into the uterus in the manner shown in FIG. 6 (except that neither member 44 or 46 is yet inflated) and constitute a foreign and disruptive body in the uterus.

It may be desired to fasten initially the abortion facilitator unit 8 in place by applying a few sutures to the cervix and around the wings 50. The apertures 54 in wings 50 also allow the physician to pass a tenaculum through the aperture in each wing and thus grasp the cervix on either side for possible carbocaine injections of the parametria.

Anchor member 44 and dilating member 46 are next inflated to their appropriate maximum sizes which will be in the range of 1.5 cm. to 4 cm., depending upon the particular size of abortion facilitating unit being used. This expansion may be accomplished by injecting a suitable amount of sterile water into the respective conduits 14 and 16. This water can be introduced through a syringe having a suitable Luer lock connection member, for example, if a Luer lock connection is packaged as part of the abortion facilitation member of the invention. Liquid is introduced via conduit 14 to promptly and fully inflate member 44, and conduit 16 is then connected to a Harvard infusion pump (not shown) with a Luer lock or other suitable connection, for the purpose of introducing at a gradual and controlled rate, a controlled quantity of liquid to inflate member 46. If resealable closure members at the ends of conduit 14 and 16 are utilized, a syringe needle can be used for introducing the proper amount of liquid.

For an anchor member having an inflated diameter of 1.5 cm. approximately 3 cc. of sterile water would be required for proper inflation. In a dilating member in which the expanded diameter of anchor 44 is 3 cm., approximately 5 cc. of water would be required, and in the anchoring member which will be 4 cm. in diameter in the inflated condition approximately 10 cc. of water would be required for proper inflation. The anchoring members are usually inflated rapidly, within about a minute or two. However, it is to be understood that the exact timing and rate of introduction of fluid is quite variable and will depend on the physician's or other medical professional's judgement of the optimum conditions for the particular patient.

The amount of liquid which is required to inflate the dilating member 46 will depend upon the size of the dilating member. For a dilating member 46 which will have a diameter of 1.5 cm. and a length of 5 cm. in the inflated condition, approximately 12 cc. of sterile water or other fluid would be required for proper inflation. A dilating member 46 which, in the inflated condition, would have a diameter of about 3 cm. and a length of about 6 cm. would be inflated with approximately 30 cc. of sterile water, and a dilating member 46 which, in the inflated condition, would have a diameter of about 4 cm. and a length of about 6 cm. would be inflated with approximately 60 cc. of sterile water. In inflating the dilating member 46, it will initially be desirable to introduce 10 to 20 percent of the filled capacity of the dilating member, recognizing that introduction of fluid can be dicontinued temporarily at any time if the patient is experiencing any substantial pain or discomfort. The remaining fluid may be introduced at a rate of about 10 percent of the filled capacity of the dilating member 46 during each half hour. However, it is to be understood that the exact timing and rate of introduction of fluid is quite variable and will depend upon the physician's or other medical professional's judgment of the optimum conditions for the particular patient.

It is to be noted that the anchoring member 44 will preferably be inflated relatively rapidly prior to commencement of inflation of dilating member 46.

The time period during which the dilatation takes place, will, of course, depend upon the amount of dilation which is to be achieved, and dilatation will most desirably be achieved gradually during a period of about 4 hours. The dilatation of the cervix can be accomplished in substantially less than 4 hours, but if done too quickly it may be painful to the patient thereby avoiding an important benefit of the practice of this invention. The precise timing and the rate will best be determined by the physician handling the patient, but it is quite desirable to do the dilating at a relatively uniform rate in order to achieve optimum results in the minimum time period with minimum patient discomfort.

As soon as the abortion facilitating device 8 of this invention is located in place within the uterus, any blood within the uterine cavity is allowed to drain out through the apertures 30 and channel 28 and exit through conduit 18. A suitable syringe may be connected to conduit 18, for the removal of any blood or other fluid. Similarly, if it is desirable to introduce medication into the uterine cavity, such as a Rivanol solution, for example, this can be introduced through a syringe suitably connected at the proximal end 38 of conduit 18.

Once the dilation has been completed, the liquid in anchor member 44 would first be removed, in the same fashion as was originally introduced, by the use of a suitable syringe, and any sutures fastening anchor member 50 to the cervix would also be cut and removed.

At this time, the liquid utilized to inflate dilating member 46 would be removed by using a syringe or pump connected to the proximal end 36 of conduit 16, as a result of which the dilating member 46 would deflate to its condition illustrated in FIG. 1. At this point in time, the abortion facilitator unit 8 would be ready for removal, and could easily be removed by the physician, at which time the cervix will be dilated to the desired degree, and the abortion can proceed.

It is to be noted that, although sterile water is preferred as the means for inflating anchor member 44 and dilating member 46, other sterile, medically acceptable fluids can be used, which could either be gases under pressure or liquids.

It will therefore be recognized that the apparatus and process of this invention provide a convenient, safe and effective method for initiating and facilitating abortions and for safely achieving cervical dilation and permitting uterine drainage and administration of medication prior to the performing of abortions.

It will be appreciated that, although particular materials, shapes and dimensions of the apparatus and of the process of this invention have been described, certain changes in these materials and shapes and dimensions and process conditions can be made without departing from the purview of this invention.

Claims

What is claimed is:

1. A process for performing an abortion to a uterus containing at least one human fetus during approximately the first 24 weeks of pregnancy, comprising steps of:

a. Inserting into the undilated cervix a radially expandable dilating member which is substantially coextensive therewith;

b. Substantially radially uniformly and gradually enlarging the expandable portion of said dilating member by the introduction therein of a fluid until the cervix is dilated an amount in the range from about 1.5 cm. to about 4 cm.;

c. Exhausting said dilating member; and

d. Removing said dilating member from the cervix.

2. A process for performing an abortion to a uterus containing at least one human fetus during approximately the first 24 weeks of pregnancy, comprising the steps of:

a. Inserting substantially into the uterine cavity an abortion facilitating device extending from the vagina into the uterine cavity and comprising a radially expandable cervical dilating member and an expandable foreign body member;

b. Seating in the undilated cervix the radially expandable dilating member and seating in the uterus the foreign body member;

c. Expanding the foreign body in the uterus;

d. Substantially radially uniformly and gradually enlarging the expandable dilating member until the cervix is dilated an amount in the range from about 1.5 cm. to about 4 cm.;

e. Exhausting said dilating member and said foreign body member; and

f. Removing said abortion facilitating device from the uterus.

3. A process as set forth in claim 2, wherein said enlarging of said dilating member occurs during a period of up to about four hours.

4. A process for performing an abortion to a uterus containing at least one human fetus during approximately the first 24 weeks of pregnancy, comprising the steps of:

a. Inserting substantially into the uterine cavity an abortion facilitating device and simultaneously seating in the substantially undilated cervix a radially expandable dilating member;

b. Substantially radially uniformly and gradually enlarging the expandable portion of said dilating member during a period of up to about 4 hours until the cervix is dilated an amount in the range from about 1.5 cm. to about 4 cm.;

c. Exhausting said dilating member; and

d. Removing said abortion facilitating device from the uterus.

5. A process as set forth in claim 4, including the final step of inserting an aborting device into the uterus to complete the abortion.

6. A process as set forth in claim 5, including the step, after insertion of the abortion facilitating device into the uterus, and prior to expansion of the dilating member, of relatively fixedly immobilizing said abortion facilitating device with respect to the cervix by expanding an anchoring member of said device within the uterus.

7. A process as set forth in claim 4 including the step of allowing the expanded dilating member to remain in the cervix for at least several hours prior to removal of the abortion facilitating device.

8. A process as set forth in claim 4, including the step of introducing medication directly into the uterus through the portion of said device extending into the uterine cavity.

9. Apparatus for cervical dilation for and facilitation of an abortion, comprising:

a. An elongated, firm, flexible shaft member having a proximal end and a distal end and defining at least two conduits commencing proximate its proximal end;

b. An expandable peripheral dilating member integral with said shaft member and having a length in the range from about 5 cm. to about 6 cm., said dilating member having a transverse dimension in the unexpanded condition of approximately the same size as the transverse dimension of the remainder of the shaft;

c. Said dilating member when inserted in the cervix of a human up to about 24 weeks pregnant being expandable in the cervix substantially in the form of a cylinder with rounded ends in the fully expanded condition and in all partially expanded conditions and having a transverse dimension in the expanded condition in the range from about 1.5 cm. to about 4 cm.;

d. An expandable peripheral anchoring member integral with said shaft member formed on the distal side of the dilating member and spaced at least in the range from about 2 cm. to about 6 cm. therefrom, and having a fully expanded transverse dimension which is approximately equal to the expanded dimension of the dilating member; and

e. One of said two conduits communicating with the interior of said dilating member and the other of said two conduits communicating with the interior of said anchoring member.

10. Apparatus as set forth in claim 9, wherein said dilating means includes an inflatable wall having a fabric scrim substantially incorporated therein.

11. Apparatus as set forth in claim 9, wherein said shaft member defines a third conduit extending from a point proximate the proximal end thereof to a point proximate the distal end thereof, said third conduit communicating with the surface of said unit proximate the distal end thereof, whereby fluid can be drained from the uterus or introduced into the uterus through said third conduit.

12. Apparatus as set forth in claim 9, including a stop member formed on said shaft member proximate and spaced about 1 cm. from the proximal end of said dilating member, and extending transverse to said shaft member and defining at least one aperture extending axially through said stop member to permit the affixation of said member in situ.

13. Apparatus as set forth in claim 9, wherein said shaft member has a rounded distal end and the proximal end terminates in three separate, spaced conduits.

14. Apparatus as set forth in claim 9, wherein said shaft member is formed of a sterilizable, smooth material.

15. Apparatus as set forth in claim 9, wherein the proximal end of each of said two conduits is closed by a resealable membrane.

16. Apparatus as set forth in claim 9, wherein said expandable anchoring member has a proximal end and said dilating member has a distal end and wherein the spacing therebetween is in the range from about 1 cm. to about 2 cm.