Patent Application
20060058831
The present invention relates to a system and method of labor induction, and in particular, to a special intracorporeal system, comprising balloons, designed to induce cervical dilation and labor induction, while performing monitoring tasks related to the labor.
There are various reasons to induce labor. For example, when a woman is two or more weeks overdue (postdate), and labor does not start on its own, it may be desirous to induce labor, due to fetal or maternal indications, such as placental dysfunction, pregnancy induced hypertension, Preeclampsia, Diabetes, intra-uterine growth restriction, conditions that may jeopardize fetal well-being, or other conditions that may effect the woman's health.
Additionally,
Labor may be induced by causing the cervix 16 to soften and open. For example, the pharmaceutical substance, prostaglandin (PG), leads to local biochemical and biophysical alterations in the cervical region that reduce cervical resistance and induce myometrial contractions. Endocervical, or vaginal application of PG, in a gel form, has gained acceptance for priming the cervix 16 before labor induction and for labor induction. A pre-manufactured mixture of 0.5 mg PGE2 and 2.5 mg triacetin gel, such as Prepidil Gel (supplied by Pharmacia N.V./S.A., For Pharmacia & Upjohn Company, a subsidiary of Pharmacia Corporation, Kalamazoo, Mich. 49001, USA) is now available, and recent trials exhibited no gel-specific problems relating to stability, homogeneity, or sterility.
Currently, the Prepidil Gel is applied by intra-cervical injection using a syringe with a simple canula. However, it is extremely difficult, if not impossible, to administer 3 ml of gel in a strictly endocervical fashion without applying some of the gel retroamniotically, which may cause side effects to uterine hypercontractility, and may lead to fetal distress.
A mechanical device for labor induction is also known. U.S. Pat. No. 4,976,692, to Atad, describes a double-balloon catheter 30, illustrated in
In accordance with a first embodiment, the catheter 30 is used for inserting a medication, such as Prepidil Gel, via a third lumen 36, in communication with the opening 48. The balloons 44 and 42 apply the gel between the external cervical os 15 and the internal cervical os 17, thus inducing labor. In accordance with a second embodiment, the proximal and distal balloons 44 and 42 alone, without gel, are used to induce labor, by pressing against the openings of the external cervical os 15 and the internal cervical os 17, triggering hormone secretion from the deciduas adjacent to the internal cervical os 17, leading to cervical dilation and labor induction without medication.
However, the double-balloon catheter 30 has certain disadvantages. The distal balloon 42 may press against the fetal head 29 (
There is thus a need for an inflatable system for cervical dilation and labor induction devoid of these limitations.
The present invention successfully addresses the shortcomings of the presently known configurations by providing an inflatable system, of between one and three balloons, for cervical dilation and labor induction. The inflatable system may have a uterine balloon, for positioning at a proximal portion of the uterus, with respect to an operator, adjacent to the cervical internal os, the uterine balloon being shaped so as to maximize the pressure against the decidua and the internal cervical os and so as to minimize the pressure on the fetal head. Additionally or alternatively, the inflatable system may have a vaginal balloon, for positioning in the vagina, for applying pressure on the external cervical os. Additionally or alternatively, the inflatable system may have a cervical balloon, for positioning in the cervical canal, the cervical balloon being shaped so as to maximize the contact area with the cervix. The balloons are operative to stimulate the secretion of hormone, by exerting pressure on the proximal decidual surfaces of the uterus and on the cervix, so as to soften and ripen the cervix, cause the cervix to dilate, and induce labor. The balloons, which may have rough external surfaces, in order to keep them anchored in place, may be inflated by the operator, directly after their insertion, or manually and gradually, by the woman herself. Various sensors and other instruments may be used with the inflatable system, to monitor cervical dilation, fetal well-being, and the woman's conditions.
In accordance with one aspect of the present invention, there is provided an inflatable system for cervical dilation and labor induction, comprising:
a catheter, which defines a coordinate system of x;y axes, a length axis substantially along the x-axis, and proximal and distal ends, with respect to an operator, along the length axis, the catheter comprising:
a uterine balloon having a uterine-balloon height, substantially parallel with the x-axis and a uterine-balloon diameter, substantially parallel with the y-axis, wherein the uterine balloon is designed to inflate so that the uterine-balloon height is no more than about 0.75 of the uterine-balloon diameter; and
a uterine-balloon lumen, in communication with the uterine balloon, via an opening in the uterine balloon lumen,
the catheter being designed for insertion into a reproductive system of a woman, having a vagina, a cervical canal, and a uterus, so that the uterine balloon and the opening in the uterine-balloon lumen are positioned at a proximal portion of the uterus, and the uterine balloon is inflated in the proximal portion of the uterus.
In accordance with an additional aspect of the present invention, the uterine balloon is designed to inflate so that the uterine-balloon height is no more than about 0.50 of the uterine-balloon diameter.
In accordance with an additional aspect of the present invention, the uterine balloon is shaped as a substantially flat disk.
In accordance with an alternative aspect of the present invention, the uterine balloon is shaped as an ellipse.
In accordance with an alternative aspect of the present invention, the uterine balloon is concave, with an apex at a proximal side thereof.
In accordance with an alternative aspect of the present invention, the uterine balloon is shaped as a cone, having a base, at a distal end thereof, parallel with the y-axis, and an apex at a proximal end thereof.
In accordance with an additional aspect of the present invention, the uterine balloon has a surface roughness, for anchoring the uterine balloon in place.
In accordance with an additional aspect of the present invention, the uterine balloon is adapted for inflation by a hand pump, by the woman, after insertion.
In accordance with an additional aspect of the present invention, the catheter further includes a cervical balloon, in communication with a cervical-balloon lumen, via an opening in the cervical-balloon lumen, the catheter being designed for insertion into the reproductive system of the woman, so that the cervical balloon and the opening in the cervical-balloon lumen are positioned within the cervical canal and the cervical balloon is inflated in the cervical canal.
In accordance with an additional aspect of the present invention, the cervical balloon is shaped as a cylinder, having a base parallel with the y-axis.
In accordance with an alternative aspect of the present invention, the cervical balloon extends proximally to the vagina and is shaped as a cone, having a base, at a proximal end thereof, in the vagina, parallel with the y-axis, and an apex at a distal end thereof, in the cervical canal.
In accordance with an additional aspect of the present invention, the cervical balloon has a surface roughness, for anchoring the cervical balloon in place.
In accordance with an additional aspect of the present invention, the cervical balloon is adapted for inflation by a hand pump, by the woman, after insertion.
In accordance with an additional aspect of the present invention, the catheter further includes a vaginal balloon, in communication with a vaginal-balloon lumen, via an opening in the vaginal-balloon lumen, the catheter being designed for insertion into the reproductive system of the woman, so that the vaginal balloon and the opening in the vaginal-balloon lumen are positioned within the vagina, at a distal portion thereof, and the vaginal balloon is inflated in the vagina.
In accordance with an additional aspect of the present invention, the vaginal balloon has a surface roughness, for anchoring the vaginal balloon in place.
In accordance with an additional aspect of the present invention, the vaginal balloon is adapted for inflation by a hand pump, by the woman, after insertion.
In accordance with an additional aspect of the present invention, the inflatable system is designed for insertion by palpation.
In accordance with an additional aspect of the present invention, the inflatable system is designed as a stand-alone system.
In accordance with an additional aspect of the present invention, the inflatable system includes at least one additional lumen, having at least one opening, the at least one additional lumen being operable for inserting at least one device to the reproductive system of the woman.
In accordance with an additional aspect of the present invention, the at least one additional lumen is operable for inserting the at least one device to the uterus.
In accordance with an alternative aspect of the present invention, the at least one additional lumen is operable for inserting the at least one device to the cervical canal.
In accordance with an alternative aspect of the present invention, the at least one additional lumen is operable for inserting the at least one device to the vagina.
In accordance with an additional aspect of the present invention, the at least one device is selected from the group consisting of a device for breaking water, a device for sensing amniotic-fluid temperature, a device for sensing fetal heart-beat, a device for measuring an extent of cervical dilation, a device for measuring a frequency of uterine contractility, a device for measuring an intensity of uterine contractility, a device for amnioscopy, a device for fetoscopy, and a device for scalp blood pH sampling.
In accordance with an additional aspect of the present invention, the at least one device further includes a transmitter for transmitting a measurement extracorporeally.
In accordance with an additional or an alternative aspect of the present invention, the at least one device includes a drug form, designed for passive dispensing of a medication.
In accordance with an additional aspect of the present invention, the passive dispensing of a medication is performed in a manner selected from the group consisting of instantaneous release, delayed release, pulsating release, timed release, and slow release.
In accordance with an alternative aspect of the present invention, the at least one device is designed for electronically-controlled dispensing of a medication.
In accordance with an additional aspect of the present invention, the device for electronically-controlled dispensing of a medication is pre-programmed.
In accordance with an additional aspect of the present invention, the device further includes a receiver and the electronically-controlled dispensing of a medication is performed responsive to an extracorporeal input.
In accordance with an additional aspect of the present invention, the device further includes at least one sensor, and the electronically-controlled dispensing of a medication is performed responsive to a measurement of the sensor, in a closed-loop manner.
In accordance with another aspect of the present invention, there is provided an inflatable system for cervical dilation and labor induction, comprising:
a catheter, which defines a coordinate system of x;y axes, a length axis substantially along the x-axis, and proximal and distal ends, with respect to an operator, along the length axis, the catheter comprising:
a cervical balloon, mounted on the catheter; and
a cervical-balloon lumen, in the catheter, in communication with the cervical-balloon, via an opening in the cervical-balloon lumen,
the catheter being designed for insertion into a reproductive system of a woman, having a vagina, a cervical canal, and a uterus, so that the cervical balloon and the opening in the cervical-balloon lumen are positioned in the cervical canal, and the cervical balloon is inflated in the cervical canal.
In accordance with an additional aspect of the present invention, the cervical balloon is shaped as a cylinder, having a base parallel with the y-axis.
In accordance with an alternative aspect of the present invention, the cervical balloon extends further to the vagina and is shaped as a cone, having a base, at a proximal end thereof, parallel with the y-axis, and an apex at a distal end thereof.
In accordance with an additional aspect of the present invention, the cervical balloon has a surface roughness, for anchoring the cervical balloon in place.
In accordance with an additional aspect of the present invention, the cervical balloon is adapted for inflation by a hand pump, by the woman, after insertion.
In accordance with an additional aspect of the present invention, the catheter further includes a vaginal balloon, in communication with a vaginal-balloon lumen, via an opening in the vaginal-balloon lumen, the catheter being designed for insertion into the reproductive system of the woman, so that the vaginal balloon and the opening in the vaginal-balloon lumen are positioned within the vagina, at a distal portion thereof, and the vaginal balloon is inflated in the vagina.
In accordance with an additional aspect of the present invention, the vaginal balloon has a surface roughness, for anchoring the vaginal balloon in place.
In accordance with an additional aspect of the present invention, the vaginal balloon is adapted for inflation by a hand pump, by the woman, after insertion.
In accordance with an additional aspect of the present invention, the inflatable system is designed for insertion by palpation.
In accordance with an additional aspect of the present invention, the inflatable system is designed as a stand-alone system.
In accordance with an additional aspect of the present invention, the inflatable system includes at least one additional lumen, having at least one opening, the at least one additional lumen being operable for inserting at least one device to the reproductive system of the woman.
In accordance with an additional aspect of the present invention, the at least one additional lumen is operable for inserting the at least one device to the uterus.
In accordance with an alternative aspect of the present invention, the at least one additional lumen is operable for inserting the at least one device to the cervical canal.
In accordance with an alternative aspect of the present invention, the at least one additional lumen is operable for inserting the at least one device to the vagina.
In accordance with an additional aspect of the present invention, the at least one device is selected from the group consisting of a device for breaking water, a device for sensing amniotic-fluid temperature, a device for sensing fetal heart-beat, a device for measuring an extent of cervical dilation, a device for measuring a frequency of uterine contractility, a device for measuring an intensity of uterine contractility, a device for amnioscopy, a device for fetoscopy, and a device for scalp blood pH sampling.
In accordance with an additional aspect of the present invention, the at least one device further includes a transmitter for transmitting a measurement extracorporeally.
In accordance with an additional or an alternative aspect of the present invention, the at least one device includes a drug form, designed for passive dispensing of a medication.
In accordance with an additional aspect of the present invention, the passive dispensing of a medication is performed in a manner selected from the group consisting of instantaneous release, delayed release, pulsating release, timed release, and slow release.
In accordance with an alternative aspect of the present invention, the at least one device is designed for electronically-controlled dispensing of a medication.
In accordance with an additional aspect of the present invention, the device for electronically-controlled dispensing of a medication is pre-programmed.
In accordance with an additional aspect of the present invention, the at least one device further includes a receiver and the electronically-controlled dispensing of a medication is performed responsive to an extracorporeal input.
In accordance with an additional aspect of the present invention, the at least one device further includes at least one sensor, and the electronically-controlled dispensing of a medication is performed responsive to a measurement of the sensor, in a closed-loop manner.
In accordance with still another aspect of the present invention, there is provided a method for cervical dilation and labor induction, comprising:
providing an inflatable system for cervical dilation and labor induction, which comprises:
inserting the catheter into a reproductive system of a woman, having a vagina, a cervical canal, and a uterus, so that the uterine balloon and the opening in the uterine-balloon lumen are positioned at a proximal portion of the uterus; and
inflating the uterine balloon in the proximal portion of the uterus.
In accordance with yet another aspect of the present invention, there is provided a method for cervical dilation and labor induction, comprising:
providing an inflatable system for cervical dilation and labor induction, which comprises:
inserting the catheter into a reproductive system of a woman, having a vagina, a cervical canal, and a uterus, so that the cervical balloon and the opening in the cervical-balloon lumen are positioned in the cervical canal; and
inflating the cervical balloon in the cervical canal.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.
In the drawings:
The present invention relates to an inflatable system, of between one and three balloons, for cervical dilation and labor induction. The inflatable system may have a uterine balloon, for positioning at a proximal portion of the uterus, with respect to an operator, adjacent to the cervical internal os, the uterine balloon being shaped so as to maximize the pressure against the decidua and the internal cervical os and so as to minimize the pressure on the fetal head. Additionally or alternatively, the inflatable system may have a vaginal balloon, for positioning in the vagina, for applying pressure on the external cervical os. Additionally or alternatively, the inflatable system may have a cervical balloon, for positioning in the cervical canal, the cervical balloon being shaped so as to maximize the contact area with the cervix. The balloons are operative to stimulate the secretion of hormone, by exerting pressure on the proximal decidual surfaces of the uterus and on the cervix, so as to soften and ripen the cervix, cause the cervix to dilate, and induce labor. The balloons, which may have rough external surfaces, in order to keep them anchored in place, may be inflated by the operator, directly after their insertion, or manually and gradually, by the woman herself. Various sensors and other instruments may be used with the inflatable system, to monitor cervical dilation, fetal well-being, and the woman's conditions.
The principles and operation of the present invention may be better understood with reference to the drawings and accompanying descriptions.
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways.
Referring now to the drawings,
As seen in
a uterine balloon 62 having a uterine-balloon height HU, substantially parallel with the x-axis, and a uterine-balloon diameter DU, substantially parallel with the y-axis, the uterine balloon 62 being shaped so that the uterine-balloon height HU is no more than about 0.75, and preferably, no more than 0.50 of the uterine-balloon diameter DU; and
a uterine-balloon lumen 64, in fluid communication with the uterine balloon 62, via an opening 63, in the uterine-balloon lumen 64.
In accordance with a first embodiment of the present invention, the catheter 52 is designed for insertion into a woman's reproductive system 20 (
Additionally, in accordance with a preferred embodiment of the present invention, the catheter 52 includes a cervical balloon 66, in communication with a cervical-balloon lumen 68, via an opening 67, in the cervical-balloon lumen 68, the cervical balloon 66 having a cervical-balloon height HC, substantially parallel with the x-axis, and a cervical-balloon diameter DC, substantially parallel with the y-axis. The catheter 52 is designed for insertion into the woman's reproductive system 20, so that the cervical balloon 66 and the opening 67 are positioned within the cervical canal 14, and the cervical balloon 66 is inflated in the cervical canal 14. In accordance with an embodiment of the present invention, the cervical balloon 66 may further extend to a distal portion of the vagina 12. The cervical balloon 66 is designed for applying pressure on the cervix 16. It will be appreciated that the pressure on the cervix 16 may further include pressure on the internal cervical os 17 and on the external cervical os 15.
Thus, as seen from
Similarly, the cervical balloon 66 is operative to stimulate hormone secretion by the cervix 16. Again, the hormone secretion is operative to soften and ripen the cervical canal 14 and induce labor.
For maximum effect, the following criteria are met:
i. the uterine balloon 62 is shaped so as to apply maximum pressure on the decidua 23 and on the internal cervical os 17;
ii. the uterine balloon 62 is further shaped so as to minimize the pressure on the fetus, inflating sideways, in the ±y direction, with minimal inflation distally, towards the fetal head, in the +x direction, so that the uterine-balloon height HU is no more than about 0.75, and preferably, no more than 0.50 of the uterine-balloon diameter DU; and
iii. the cervical balloon 66 is shaped so a to have a maximum contact area with the cervix 16, for applying pressure on the cervix 16, preferably, including the internal cervical os 17 and the external cervical os 15, to accelerate cervical dilation.
Preferably, the inflatable system 50 is inflated in stages, as illustrated in
For withdrawal, the inflatable system 50 is deflated, returning to the state of t=0 (
As seen in
It will be appreciated that the system 50 may be designed as a stand-alone system, so the woman may move freely with the system 50 inserted.
In accordance with a preferred embodiment of the present invention, seen in
The uterine balloon 62, shaped so that the uterine-balloon height HU is no more than about 0.75, and preferably, no more than 0.50 of the uterine-balloon diameter DU, the uterine balloon 62 being in fluid communication with the uterine balloon lumen 64, via the opening 63, and the uterine balloon 62 being adapted for positioning at the proximal portion of the uterus 18, for applying pressure on the internal cervical os 17 and the decidua 23. For example, the uterine-balloon diameter DU may be 6 cm and the uterine-balloon height HU may be 2 cm. It will be appreciated that other dimensions are also possible.
Additionally, the inflatable system 50 may include the cervical balloon 66, in fluid communication with the cervical-balloon lumen 68, via the opening 67, the cervical balloon 66 being adapted for positioning within the cervical canal 14, for applying pressure on the cervix 16. It will be appreciated that the pressure on the cervix 16 may further include pressure on the internal cervical os 17 and on the external cervical os 15. Preferably the cervical balloon 66 is shaped so that the cervical-balloon diameter DC is greater than the cervical-balloon height HC. For example, the cervical-balloon diameter may be 6 cm, and the cervical-balloon height HC may be 4 cm. It will be appreciated that other dimensions are also possible. Alternatively, a round cervical balloon may be used.
Furthermore, the inflatable system 50 may include a vaginal balloon 59, in fluid communication with a vaginal-balloon lumen 55, via an opening 57, the vaginal balloon 59 being adapted for positioning within the vagina 12, at a distal portion thereof, for pressing against the external cervical os 15. Preferably, a vaginal-balloon diameter DV is greater than a vaginal-balloon height HV. For example, the vaginal-balloon diameter DV may be 6 cm, and the vaginal-balloon height HV may be 3 cm. It will be appreciated that other dimensions are also possible. Alternatively, a round balloon may be used.
In accordance with the preferred embodiment of the present invention, of the three-balloon inflatable system 50, illustrated in
As seen in
As seen in
As seen in
As seen in
As seen in
For withdrawal, the inflatable system 50 is deflated, returning to the state of t=0 (
In accordance with the present invention, the inflation of the balloons of the inflatable system 50 may be performed by the doctor or midwife (not shown) directly after their insertion. Alternatively, the inflation of the balloons of the inflatable system 50 may be performed by the woman, via hand pumps 65 (
Referring further to the drawings,
With regard to the uterine balloon 62, shaped so that the uterine-balloon height HU is no more than about 0.75, and preferably, no more than 0.50 of the uterine-balloon diameter DU, in order to maximize the pressure against the decidua 23 and the internal cervical os 17, and to minimize the pressure on the fetal head 29:
However, in accordance with an alternative embodiment, seen in
With regard to the cervical balloon 66, designed to apply pressure on the cervix 16, the internal cervical os 17, and preferably also the external cervical os 15:
However, in accordance with an alternative embodiment, seen in
It will be appreciated that in accordance with alternative embodiments of the present invention, seen in
It will be appreciated that even for the three-balloon system, the uterine balloon 62 may be shaped as any one of the uterine balloons of
Referring further to the drawings,
Preferably, the system 50 includes at least one additional lumen 70, having at least one opening 69, to the uterus 18, and possibly an additional opening 61, to the cervical canal 14. The at least one additional lumen 70 is operable for inserting at least one device 90 to the woman's reproductive system 20.
In accordance with an aspect of the present invention, the at least one additional lumen 70 is operable for inserting the at least one device 90 to the uterus 18, via the opening 69.
Alternatively, the at least one additional lumen 70 is operable for inserting the at least one device 90 to the cervical canal 14, via the opening 61.
As seen in
As seen in
It will be appreciated that the device 90 may be selected from the group consisting of device for breaking water, a device for sensing amniotic-fluid temperature, a device for sensing fetal heart-beat, a device for measuring an extent of cervical dilation, a device for measuring a frequency of uterine contractility, a device for measuring an intensity of uterine contractility, a device for amnioscopy, a device for fetoscopy, a device for scalp blood pH sampling, and other measuring devices as known.
As seen in
The passive dispensing of a medication may be by instantaneous release, delayed release, pulsating release, timed release, slow release, or another release form, as known, operable via the opening 69 to the uterus 18, or via the openings 61 to the cervical canal 14.
As seen in
As seen in
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As seen in
Referring further to the drawings,
Accordingly, the devices 94 and (or) 96 include:
a sensor 102, for performing the sensing or the measuring;
preferably also, a transmitter 106, such as an RF or an IR transmitter, for transmitting the sensing or the measuring, extracorporeally;
a power source 104, for powering the device 90; and
a dedicated circuitry 100, as needed.
Accordingly, the device 95 includes a drug pouch 105, controlled by an electronically controlled valve 108, which is powered by the power source 104. The dedicated circuitry 100, may be included, as needed, and may be preprogrammed for a specific drug-release schedule.
Accordingly, the device 95 includes the drug pouch 105, controlled by the electronically controlled valve 108, which is powered by the power source 104, and which dispenses the drug, responsive to extracorporeal instructions, as received via a receiver 110. The dedicated circuitry 100, may be included, as needed.
Accordingly, the device 95 includes the drug pouch 105, controlled by the electronically-controlled valve 108, which is powered by the power source 104, and which dispenses the drug, responsive to input of the sensor 102. The dedicated circuitry 100, may be included, as needed. The sensor 102 may be, for example, a sensor for amniotic-fluid temperature, a sensor for fetal heart-beat, or a device for measuring the extent of cervical dilation.
It will be appreciated that in any one of
Referring further to the drawings,
At times, it may be desirous for the inflatable system 50 to include only the cervical balloon 66. This may happen, for example, that spontaneous labor has started, but the woman wishes to speed it up. Using the hand-pump 65C, she may inflate the cervical balloon 66 gradually, so as to continuously increase the pressure on the cervix 16 and hasten its dilation. However, without being anchored by the vaginal balloon 59, or held in place by the uterine balloon 62, the cervical balloon 59 may slide out of position. Therefore, as seen in
It will be appreciated that the surface roughness 73 may be similarly applied to the uterine balloon 62 and (or) to the vaginal balloon 59. Additionally, the surface roughness 73 may be applied whether the inflatable system 50 is of a single balloon, two balloons, or three balloons.
As used herein the term “about” refers to ±20%.
It is expected that during the life of this patent, many relevant inflatable systems for cervical dilation may be developed and the scope of the term inflatable system for cervical dilation and labor induction is intended to include all such new technologies a priori.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, a citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.
