US3848602A - Abortion facilitating device and process - Google Patents
Abortion facilitating device and process Download PDFInfo
- Publication number
- US3848602A US3848602A US00245310A US24531072A US3848602A US 3848602 A US3848602 A US 3848602A US 00245310 A US00245310 A US 00245310A US 24531072 A US24531072 A US 24531072A US 3848602 A US3848602 A US 3848602A
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- United States
- Prior art keywords
- abortion
- dilating
- cervix
- uterus
- dilating member
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- Expired - Lifetime
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
Definitions
- Drobile 5 7 ABSTRACT A process for cervical dilation prior to the perform ance 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.
- the invention relates to a cervical dilating apparatus v and process for performing an abortion which has the effects of dilating the cervix and facilitating, and, on some occasions, spontaneously initiating an 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 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.
- the process of the invention comprises the insertion of the dilationdevice of the invention into and through the cervix, so that the distal end thereto extends into the lower segment of the uterine cavity, expansion ofan 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.
- the abortion facilitator may be allowed to reside in place for a substantial period of time, preferably overnight.
- 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.
- 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 patients vagina during the dilation procedure with the distal end thereof which is located within the patients uterus.
- 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 theshaft 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
- the dilating member in the inflated state is of substantially cylindrical shape and has a transverse dimension of from about l'.5 cm. to about 4 cm., and a length of from about 5cm. to about 6 cm.
- the dilating member 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 as which surrounds it.
- the anchoringmember is supplied with fluid from a separate conduit formed in the shaft.
- the anchoring member body expands to a transverse dimension approximately equalto the expanded transverse dimension of the dilating member. it is inflated, in use, prior to inflation of the dilating member, and serves to an chor 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.
- a pair of wings Spaced from and proximate the proximal end of the dilating member is a pair of wings, extending transversely in the body of the shaftmember, 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.
- 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.
- 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 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,
- 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 44 of FIG. 2;
- FIG. 5 is a cross-sectional view taken along line 55 of FIG. 2;
- 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.
- the abortion facilitator unit of this invention 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 l4, l6 and 18.
- the conduits l4, l6 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.
- 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.
- conduits 14, 16 and 18 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 uterme.
- 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 l0, and having substantially the same cross-sectional 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.
- 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 l.O cm. to about 1.5 cm., for purposes more fully to be described hereinafter.
- 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.
- a second an chor member 50 Formed inboard the proximal end of dilating member 46, and spaced about 1 cm. therefrom, is a second an chor 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 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, nontoxic, non-irritating material, of a type which is wellknown 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 withinsional integrity of the dilating member is maintained, in
- 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 facilitatordevice inside, and replacing the interior of the envelope with a sterilizing medium such as ethylene oxide, and subsequently evacuating and sealing the envelope.
- a sterilizing medium such as ethylene oxide
- 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 l4 and 16 and channels 24 and 26 when the dilating unit is located in situ.
- 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).
- 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).
- 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.
- pregnancies which are at orbeyond 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 dila tation 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 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.
- 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. lf 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 doctors 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.
- the amount of cervical dilation desired is at least about l mm. Therefore, for performing abortions during the first 6 weeks of pregnancy, the length of the dilating member 46 would be about cm., and its inflated diameter would be about somewhat greater than mm. and would preferably be expandable up to about 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.
- 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 mm. and would also have a length of approximately 6 cm.
- 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 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
- 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.
- 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.
- 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.
- 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 intothe 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.
- the deflated dilating member 46 is seated within the cervical canal or cervical s and the proximal end of shaft member 10 and conduits 14, 16 and 18 extend substantially without the patients vagina, for easy connection to suitable fluid introduction devices.
- the distal end of the abortion facilitator unit, including anchor member 44 extend into the uterus in the manner shown in F IG. 6 (except that neither member 44 or 46 is yet inflated) and constitute a foreign and disruptive body in the uterus.
- the apertures 54 in wings 50 also allow thephysician 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.
- 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 physicians or other medical professionals 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 cc. of sterile water.
- 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.
- timing and rate of introduction of fluid is quite variable and will depend upon the physicians or other medical professionals judgment of the optimum conditions for the particular patient.
- 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.
- 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.
- medication such as a Rivanol solution, for example, this can be introduced through a syringe suitably connected at the proximal end 38 of conduit 18.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
- 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;
- 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 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.
- Apparatus for cervical dilation for and facilitation of an abortion comprising:
- 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;
- 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.;
- 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.
- said dilating means includes an inflatable wall having a fabric scrim substantially incorporated therein.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Surgery (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Gynecology & Obstetrics (AREA)
- Child & Adolescent Psychology (AREA)
- Biophysics (AREA)
- Pregnancy & Childbirth (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pulmonology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Surgical Instruments (AREA)
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US00245310A US3848602A (en) | 1972-04-19 | 1972-04-19 | Abortion facilitating device and process |
IN895/CAL/73A IN138715B (pt) | 1972-04-19 | 1973-04-17 | |
CA168,902A CA1010737A (en) | 1972-04-19 | 1973-04-17 | Miscarriage inducing apparatus |
BR2845/73A BR7302845D0 (pt) | 1972-04-19 | 1973-04-18 | Aparelho para facilitar aborto |
DE2320250A DE2320250A1 (de) | 1972-04-19 | 1973-04-19 | Abortus erleichternde vorrichtung |
FR7314428A FR2181024B1 (pt) | 1972-04-19 | 1973-04-19 | |
GB1909373A GB1426278A (en) | 1972-04-19 | 1973-04-19 | Abortion facilitating devices and processes |
JP48044609A JPS5125997B2 (pt) | 1972-04-19 | 1973-04-19 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US00245310A US3848602A (en) | 1972-04-19 | 1972-04-19 | Abortion facilitating device and process |
Publications (1)
Publication Number | Publication Date |
---|---|
US3848602A true US3848602A (en) | 1974-11-19 |
Family
ID=22926151
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US00245310A Expired - Lifetime US3848602A (en) | 1972-04-19 | 1972-04-19 | Abortion facilitating device and process |
Country Status (8)
Country | Link |
---|---|
US (1) | US3848602A (pt) |
JP (1) | JPS5125997B2 (pt) |
BR (1) | BR7302845D0 (pt) |
CA (1) | CA1010737A (pt) |
DE (1) | DE2320250A1 (pt) |
FR (1) | FR2181024B1 (pt) |
GB (1) | GB1426278A (pt) |
IN (1) | IN138715B (pt) |
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US4100923A (en) * | 1976-12-16 | 1978-07-18 | The Upjohn Company | Extra-amniotic administration device |
US4137922A (en) * | 1973-03-07 | 1979-02-06 | Ortho Pharmaceutical Corp. | Dilator for cervical canal |
WO1982000409A1 (en) * | 1980-07-28 | 1982-02-18 | T Fogarty | Calibrating dilatation catheter method and apparatus |
US4403603A (en) * | 1979-10-04 | 1983-09-13 | Hutchins Rhonda P | Method to enhance artificial dog breeding |
US4596554A (en) * | 1985-04-19 | 1986-06-24 | Dastgeer Ghulam M | Colo-rectal evacuator |
US4664114A (en) * | 1985-08-12 | 1987-05-12 | Kamran Ghodsian | Dilator for cervical canal |
US4686985A (en) * | 1985-05-15 | 1987-08-18 | Lottick Edward A | Anal dilator and occluder |
FR2612402A1 (fr) * | 1987-03-18 | 1988-09-23 | Bouton Vincent | Sonde sinusienne a canaux multiples |
US4790820A (en) * | 1981-07-13 | 1988-12-13 | Alza Corporation | Parenteral agent dispensing equipment with drug releasing member |
US4836204A (en) * | 1987-07-06 | 1989-06-06 | Landymore Roderick W | Method for effecting closure of a perforation in the septum of the heart |
US4857052A (en) * | 1981-07-13 | 1989-08-15 | Alza Corporation | Intravenous system for delivering a beneficial agent |
WO1989011890A1 (en) * | 1988-06-02 | 1989-12-14 | Advanced Surgical Intervention, Inc. | Balloon dilation catheter |
US5007898A (en) * | 1988-06-02 | 1991-04-16 | Advanced Surgical Intervention, Inc. | Balloon dilatation catheter |
US5009636A (en) * | 1989-12-06 | 1991-04-23 | The Kendall Company | Dual-lumen catheter apparatus and method |
US5082006A (en) * | 1987-09-15 | 1992-01-21 | Linda Jonasson | Device for preventing involuntary micturition |
US5104377A (en) * | 1989-08-10 | 1992-04-14 | C. R. Bard, Inc. | Uterine access device with automatic cervical adjustment |
USRE34365E (en) * | 1981-07-13 | 1993-08-31 | Intravenous system for delivering a beneficial agent | |
US5248304A (en) * | 1992-05-29 | 1993-09-28 | Michael Vigdorchik | Single use intrauterine injector |
US5312430A (en) * | 1986-12-09 | 1994-05-17 | Rosenbluth Robert F | Balloon dilation catheter |
US5374245A (en) * | 1990-01-10 | 1994-12-20 | Mahurkar; Sakharam D. | Reinforced multiple-lumen catheter and apparatus and method for making the same |
US5527336A (en) * | 1986-12-09 | 1996-06-18 | Boston Scientific Corporation | Flow obstruction treatment method |
US5634936A (en) * | 1995-02-06 | 1997-06-03 | Scimed Life Systems, Inc. | Device for closing a septal defect |
US5797869A (en) * | 1987-12-22 | 1998-08-25 | Vas-Cath Incorporated | Multiple lumen catheter |
US5891457A (en) * | 1997-05-12 | 1999-04-06 | Neuwirth; Robert S. | Intrauterine chemical necrosing method, composition, and apparatus |
WO2000018464A1 (en) * | 1998-09-29 | 2000-04-06 | Smiths Industries Public Limited Company | Uterine catheter |
US6187346B1 (en) | 1995-06-07 | 2001-02-13 | Ablation Products, Inc. | Intrauterine chemical cauterizing method and composition |
US6197351B1 (en) | 1995-06-07 | 2001-03-06 | Robert S. Neuwirth | Intrauterine chemical necrosing method and composition |
USRE37704E1 (en) | 1990-03-22 | 2002-05-14 | Argomed Ltd. | Thermal treatment apparatus |
US20040116955A1 (en) * | 2002-12-12 | 2004-06-17 | Jonathan Foltz | Cervical canal dilator |
US20040122463A1 (en) * | 2002-11-21 | 2004-06-24 | Hibler Timothy B. | Cervical medical device, system and method |
US20050055043A1 (en) * | 2002-12-12 | 2005-03-10 | Os Technology, Llc. | Cervical canal dilator |
US20060079845A1 (en) * | 2004-10-08 | 2006-04-13 | Eben Howard And Pamela A. Howard | Movable inflatable anchor for medical devices |
US20070288051A1 (en) * | 2006-04-17 | 2007-12-13 | Bruce Beyer | Fluid-filled cervical dilator |
US20080077054A1 (en) * | 2006-08-28 | 2008-03-27 | Femsuite, Llc | Cervical dilator and methods of use |
US20080215031A1 (en) * | 2007-02-09 | 2008-09-04 | Belfort Michael A | Pelvic balloon tamponade |
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US20090227970A1 (en) * | 2006-10-17 | 2009-09-10 | C.R. Bard, Inc. | Waste management system |
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CN102805660A (zh) * | 2012-08-13 | 2012-12-05 | 东南大学 | 一种用于可视化人流的子宫撑开及内窥装置 |
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US20140336574A1 (en) * | 2011-12-16 | 2014-11-13 | Musc Foundation For Research Development | Double balloon catheter |
WO2016067233A1 (en) | 2014-10-31 | 2016-05-06 | Glam Snc | A system of curettage of the uterine cavity and dilation of the cervical canal |
FR3085853A1 (fr) * | 2018-09-14 | 2020-03-20 | Laurent Ejnes | Dispositif medical de dilatation du col de l'uterus d'un etre humain ou animal |
US11241254B2 (en) | 2012-03-15 | 2022-02-08 | Alydia Health, Inc. | Uterine hemorrhage controlling system and method |
US20220226606A1 (en) * | 2021-01-20 | 2022-07-21 | Gregory Douglas Wood | Obstetrical Urinary Catheter |
US20220233211A1 (en) * | 2019-03-19 | 2022-07-28 | Atropos Limited | Curette and use thereof |
US11471654B2 (en) * | 2018-06-01 | 2022-10-18 | Projectd, Llc | Dilation device and method of use |
US11517336B2 (en) * | 2016-08-24 | 2022-12-06 | Alydia Health, Inc. | Uterine hemorrhage controlling system and method |
US12076047B2 (en) | 2012-03-15 | 2024-09-03 | Alydia Health, Inc. | Uterine hemorrhage controlling system and method |
Families Citing this family (12)
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JPS5239596B2 (pt) * | 1974-04-04 | 1977-10-06 | ||
JPS5214488U (pt) * | 1975-07-18 | 1977-02-01 | ||
JPS5234233A (en) * | 1975-09-12 | 1977-03-16 | Mitsubishi Petrochemical Co | Film for farming |
JPS5243637A (en) * | 1975-09-25 | 1977-04-05 | Eiji Arie | Synthetic resin film for cultivation of leaf and stem vegetable |
CH616337A5 (pt) * | 1977-10-21 | 1980-03-31 | Schneider Medintag Ag | |
JPS6030347B2 (ja) * | 1978-07-06 | 1985-07-16 | 積水化学工業株式会社 | 熱可塑性樹脂成形品 |
JPS5794852U (pt) * | 1980-12-02 | 1982-06-11 | ||
FR2545360B1 (fr) * | 1983-07-29 | 1986-01-10 | Archeny Jean Pierre | Sonde intra-uterine pour hysterographie et mesure de la permeabilite des trompes |
FR2551978B1 (fr) * | 1983-09-15 | 1988-12-16 | Archeny Jean Pierre | Sonde intra-uterine pour hysterographie et mesure de la permeabilite des trompes |
JPS61170322A (ja) * | 1985-01-24 | 1986-08-01 | 三菱化成ビニル株式会社 | 農業用合成樹脂フイルム |
US5454788A (en) * | 1991-04-24 | 1995-10-03 | Baxter International Inc. | Exchangeable integrated-wire balloon catheter |
DE69224636T2 (de) * | 1991-04-24 | 1998-11-05 | Advanced Cardiovascular System | Auswechselbarer ballonkatheter mit integriertem führungsdraht |
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- 1973-04-17 CA CA168,902A patent/CA1010737A/en not_active Expired
- 1973-04-17 IN IN895/CAL/73A patent/IN138715B/en unknown
- 1973-04-18 BR BR2845/73A patent/BR7302845D0/pt unknown
- 1973-04-19 JP JP48044609A patent/JPS5125997B2/ja not_active Expired
- 1973-04-19 GB GB1909373A patent/GB1426278A/en not_active Expired
- 1973-04-19 DE DE2320250A patent/DE2320250A1/de active Pending
- 1973-04-19 FR FR7314428A patent/FR2181024B1/fr not_active Expired
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Cited By (81)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4137922A (en) * | 1973-03-07 | 1979-02-06 | Ortho Pharmaceutical Corp. | Dilator for cervical canal |
US4100923A (en) * | 1976-12-16 | 1978-07-18 | The Upjohn Company | Extra-amniotic administration device |
US4403603A (en) * | 1979-10-04 | 1983-09-13 | Hutchins Rhonda P | Method to enhance artificial dog breeding |
WO1982000409A1 (en) * | 1980-07-28 | 1982-02-18 | T Fogarty | Calibrating dilatation catheter method and apparatus |
US4328811A (en) * | 1980-07-28 | 1982-05-11 | Fogarty Thomas J | Calibrating dilation catheter |
US4857052A (en) * | 1981-07-13 | 1989-08-15 | Alza Corporation | Intravenous system for delivering a beneficial agent |
USRE34365E (en) * | 1981-07-13 | 1993-08-31 | Intravenous system for delivering a beneficial agent | |
US4790820A (en) * | 1981-07-13 | 1988-12-13 | Alza Corporation | Parenteral agent dispensing equipment with drug releasing member |
US4596554A (en) * | 1985-04-19 | 1986-06-24 | Dastgeer Ghulam M | Colo-rectal evacuator |
US4686985A (en) * | 1985-05-15 | 1987-08-18 | Lottick Edward A | Anal dilator and occluder |
US4664114A (en) * | 1985-08-12 | 1987-05-12 | Kamran Ghodsian | Dilator for cervical canal |
US5836951A (en) * | 1986-12-09 | 1998-11-17 | Boston Scientific Corporation | Balloon dilation catheter |
US5752971A (en) * | 1986-12-09 | 1998-05-19 | Boston Scientific Technology, Inc. | Method of treating a flow obstruction |
US5527336A (en) * | 1986-12-09 | 1996-06-18 | Boston Scientific Corporation | Flow obstruction treatment method |
US5312430A (en) * | 1986-12-09 | 1994-05-17 | Rosenbluth Robert F | Balloon dilation catheter |
FR2612402A1 (fr) * | 1987-03-18 | 1988-09-23 | Bouton Vincent | Sonde sinusienne a canaux multiples |
US4836204A (en) * | 1987-07-06 | 1989-06-06 | Landymore Roderick W | Method for effecting closure of a perforation in the septum of the heart |
US5082006A (en) * | 1987-09-15 | 1992-01-21 | Linda Jonasson | Device for preventing involuntary micturition |
US6206849B1 (en) | 1987-12-22 | 2001-03-27 | Vas-Cath Incorporated | Multiple lumen catheter |
US7229429B2 (en) | 1987-12-22 | 2007-06-12 | Vas-Cath Inc. | Multiple lumen catheter |
US5797869A (en) * | 1987-12-22 | 1998-08-25 | Vas-Cath Incorporated | Multiple lumen catheter |
US5007898A (en) * | 1988-06-02 | 1991-04-16 | Advanced Surgical Intervention, Inc. | Balloon dilatation catheter |
US5030227A (en) * | 1988-06-02 | 1991-07-09 | Advanced Surgical Intervention, Inc. | Balloon dilation catheter |
WO1989011890A1 (en) * | 1988-06-02 | 1989-12-14 | Advanced Surgical Intervention, Inc. | Balloon dilation catheter |
US5104377A (en) * | 1989-08-10 | 1992-04-14 | C. R. Bard, Inc. | Uterine access device with automatic cervical adjustment |
US5009636A (en) * | 1989-12-06 | 1991-04-23 | The Kendall Company | Dual-lumen catheter apparatus and method |
US5374245A (en) * | 1990-01-10 | 1994-12-20 | Mahurkar; Sakharam D. | Reinforced multiple-lumen catheter and apparatus and method for making the same |
USRE37704E1 (en) | 1990-03-22 | 2002-05-14 | Argomed Ltd. | Thermal treatment apparatus |
US5248304A (en) * | 1992-05-29 | 1993-09-28 | Michael Vigdorchik | Single use intrauterine injector |
US5634936A (en) * | 1995-02-06 | 1997-06-03 | Scimed Life Systems, Inc. | Device for closing a septal defect |
US6270515B1 (en) | 1995-02-06 | 2001-08-07 | Scimed Life Systems, Inc. | Device for closing a septal defect |
US6187346B1 (en) | 1995-06-07 | 2001-02-13 | Ablation Products, Inc. | Intrauterine chemical cauterizing method and composition |
US6197351B1 (en) | 1995-06-07 | 2001-03-06 | Robert S. Neuwirth | Intrauterine chemical necrosing method and composition |
US6165492A (en) * | 1997-05-12 | 2000-12-26 | Neuwirth; Robert S. | Intrauterine chemical necrosing method, composition, and apparatus |
US5891457A (en) * | 1997-05-12 | 1999-04-06 | Neuwirth; Robert S. | Intrauterine chemical necrosing method, composition, and apparatus |
WO2000018464A1 (en) * | 1998-09-29 | 2000-04-06 | Smiths Industries Public Limited Company | Uterine catheter |
US20040122463A1 (en) * | 2002-11-21 | 2004-06-24 | Hibler Timothy B. | Cervical medical device, system and method |
US20070032814A1 (en) * | 2002-11-21 | 2007-02-08 | Hibler Timothy B | Cervical Medical Device, System and Method |
US7105007B2 (en) * | 2002-11-21 | 2006-09-12 | Hibler Timothy B | Cervical medical device, system and method |
US20040116955A1 (en) * | 2002-12-12 | 2004-06-17 | Jonathan Foltz | Cervical canal dilator |
US20050055043A1 (en) * | 2002-12-12 | 2005-03-10 | Os Technology, Llc. | Cervical canal dilator |
US20050149100A1 (en) * | 2002-12-12 | 2005-07-07 | O.S. Technology Llc | Cervical canal dilator |
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US20060079845A1 (en) * | 2004-10-08 | 2006-04-13 | Eben Howard And Pamela A. Howard | Movable inflatable anchor for medical devices |
US20070288051A1 (en) * | 2006-04-17 | 2007-12-13 | Bruce Beyer | Fluid-filled cervical dilator |
US20080077054A1 (en) * | 2006-08-28 | 2008-03-27 | Femsuite, Llc | Cervical dilator and methods of use |
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Also Published As
Publication number | Publication date |
---|---|
FR2181024A1 (pt) | 1973-11-30 |
IN138715B (pt) | 1976-03-20 |
BR7302845D0 (pt) | 1974-08-29 |
JPS4917093A (pt) | 1974-02-15 |
GB1426278A (en) | 1976-02-25 |
JPS5125997B2 (pt) | 1976-08-03 |
FR2181024B1 (pt) | 1978-11-03 |
DE2320250A1 (de) | 1973-10-25 |
CA1010737A (en) | 1977-05-24 |
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