U.S. patent application number 16/367132 was filed with the patent office on 2020-10-01 for system and method for child-birth monitoring and assistance.
The applicant listed for this patent is Kamran Ghodsian. Invention is credited to Kamran Ghodsian.
Application Number | 20200305742 16/367132 |
Document ID | / |
Family ID | 1000003992561 |
Filed Date | 2020-10-01 |
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United States Patent
Application |
20200305742 |
Kind Code |
A1 |
Ghodsian; Kamran |
October 1, 2020 |
SYSTEM AND METHOD FOR CHILD-BIRTH MONITORING AND ASSISTANCE
Abstract
The invention is generally a system, apparatus, and method for
monitoring and measuring a change in intrauterine pressure without
rupturing the amniotic sac. A catheter is coupled to a pressure
sensing module. The pressure sensing module is configured with a
chamber that is in fluid communication with a balloon of the
catheter. The chamber includes a pressure-sensing membrane coupled
to sensing circuitry. The sensing circuitry is configured to detect
a pressure applied to the pressure-sensing membrane and communicate
the condition to a monitor of the system. Methods include inserting
the catheter through the cervix so that the balloon may be inflated
and situated in the lower segment of the uterus, resting against
the amniotic sac. Because the balloon of the catheter is in fluid
communication with the pressure-sensing membrane, pulsations of the
amniotic sac will be sensed by the sensing circuitry of the
pressure sensing module.
Inventors: |
Ghodsian; Kamran; (Newport
Beach, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ghodsian; Kamran |
Newport Beach |
CA |
US |
|
|
Family ID: |
1000003992561 |
Appl. No.: |
16/367132 |
Filed: |
March 27, 2019 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 1/303 20130101;
A61B 2562/0271 20130101; A61B 2562/0247 20130101; A61B 5/6875
20130101; A61B 5/035 20130101; A61B 5/6853 20130101 |
International
Class: |
A61B 5/03 20060101
A61B005/03; A61B 5/00 20060101 A61B005/00; A61B 1/303 20060101
A61B001/303 |
Claims
1. A system for monitoring and measuring a change in intrauterine
pressure during labor, without rupturing an amniotic sac,
comprising: a catheter configured for manipulation by an operator,
the catheter including: a distal end adapted to be placed at least
partially inside a cervix of a patient; a uterine balloon situated
substantially at the distal end of the catheter adapted to be
placed at least partially inside a lower segment of a uterus of the
patient; a first port situated at the proximal end of the catheter;
a conduit fluidly communicating the first port to an interior of
the uterine balloon, wherein the uterine balloon is inflated by
introducing a fluid through the first port; a blunt distal tip
having a distal opening; a lumen extending throughout the length of
the catheter from the distal opening to the proximal end; a hollow
tubular support in the lumen to support the uterine balloon and
maintain patency of the lumen to provide access to the amniotic sac
through the distal opening; and a pressure-sensing module coupled
to the catheter configured to detect a pressure applied to the
uterine balloon of the catheter.
2. (canceled)
3. (canceled)
4. The system of claim 1, wherein the catheter further comprises a
second balloon that is a vaginal balloon situated closer to the
proximal end of the catheter than the uterine balloon and adapted
to secure the uterine balloon inside the uterus.
5. The system of claim 1, further comprising sensing circuitry
including a communications module to transmit sensing data
concerning the pressure applied to the uterine balloon of the
catheter.
6. (canceled)
7. The system of claim 1, wherein the pressure-sensing module is
removably coupled to the sensing circuitry, the sensing circuitry
situated external to the pressure-sensing module.
8. The system of claim 1, further comprising a monitor for reading
sensing data concerning the pressure applied to the uterine balloon
of the catheter.
9. (canceled)
10. (canceled)
11. (canceled)
12. (canceled)
13. (canceled)
14. (canceled)
15. (canceled)
16. A method for monitoring and measuring a change in intrauterine
pressure during labor, without rupturing the amniotic sac,
comprising the steps of: coupling a pressure-sensing module to a
catheter; inserting the catheter into a vagina and through a
cervical canal of a female patient, wherein: a distal end of the
catheter is placed inside the cervical canal, and a proximal end of
the catheter is kept outside the cervical canal, the catheter
including: a uterine balloon in fluid communication with the
proximal end and attached at or near the distal end of the
catheter, a first port situated at the proximate end of the
catheter, a second port situated at the proximate end of the
catheter, a conduit fluidly communicating the first port and the
second port to an interior of the uterine balloon, and a vaginal
balloon situated closer to the proximate end of the catheter than
the uterine balloon and adapted to secure the uterine balloon
inside the uterus; inflating the uterine balloon from the proximal
end and through the catheter by introducing a fluid through a first
port of the catheter so that the fluid inflates the balloon and
enters a first chamber of the sensing module; inflating the vaginal
balloon to anchor the uterine balloon inside the lower segment of
the uterus so that the uterine balloon rests against an amniotic
sac of the female patient; and reading a pressure output from the
pressure-sensing module.
17. The method of claim 16, further comprising positioning the
uterine balloon at a lower segment of a uterus of the female
patient, prior to inflating the uterine balloon.
18. The method of claim 16, further comprising positioning the
vaginal balloon at an external orifice of the uterus of the female
patient, prior to inflating the vaginal balloon.
19. The method of claim 16, further comprising inserting, through
an opening at the distal end of the catheter, a temperature
transducer.
20. The method of claim 16, further comprising inserting, through
an opening at the distal end of the catheter, an image transducer.
Description
TECHNICAL FIELD OF THE INVENTION
[0001] The present invention relates generally to processes of
child-birth monitoring and assistance. More specifically, the
present invention relates to a system, apparatus, and method for
monitoring and measuring a change in intrauterine pressure during
labor, without rupturing the amniotic sac.
COPYRIGHT AND TRADEMARK NOTICE
[0002] A portion of the disclosure of this patent application may
contain material that is subject to copyright protection. The owner
has no objection to the facsimile reproduction by anyone of the
patent document or the patent disclosure, as it appears in the
Patent and Trademark Office patent file or records, but otherwise
reserves all copyrights whatsoever.
[0003] Certain marks referenced herein may be common law or
registered trademarks of third parties affiliated or unaffiliated
with the applicant or the assignee. Use of these marks is by way of
example and should not be construed as descriptive or to limit the
scope of this invention to material associated only with such
marks.
BACKGROUND OF THE INVENTION
[0004] 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, intrauterine growth
restriction, conditions that may jeopardize fetal well-being, or
other conditions that may affect the woman's health.
[0005] Labor may be induced by causing the cervix 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, is presently used for priming the cervix before
labor induction and for labor induction. Currently, the Prepidil
Gel is applied by intracervical 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.
[0006] Intracorporeal labor induction systems of the prior art do
not control or measure uterus/amniotic-fluid pressure. By clogging
the cervical canal, the existing systems make it hard, if not
impossible, to insert a separate pressure measuring instrument into
a patient's reproductive system to measure uterus and
amniotic-fluid pressures. Furthermore, available
uterus/amniotic-fluid pressure measurement devices are inherently
inaccurate.
[0007] During many labor-inducing procedures, it is desirable to
monitor and measure a condition within the uterus. However, known
methods often rely on apparatus or devices that are inherently
inaccurate and often cause or require the amniotic sac to be
ruptured. An advantage of obtaining accurate measurements without
breaching the amniotic sac is a decrease in the rate of
intrauterine infection for the mother and decrease of infection for
the fetus during labor. For example, it is desirable to evaluate
the intrauterine pressure during labor before rupturing the
amniotic sac. Current methods inadequately address this need.
[0008] Accordingly, the prior art inadequately addresses labor
monitoring systems that: (i) may induce labor while accurately
measuring the uterus and amniotic fluid pressure without rupturing
the amniotic sac, (ii) facilitate control of the uterus and
amniotic fluid pressure without rupturing the amniotic sac, and
(iii) facilitate measuring and or observing a frequency of uterine
contractions, without rupturing the amniotic sac.
[0009] Therefore, there is a need for a system, apparatus, and
method that facilitates the monitoring and measuring of a condition
inside the uterus during labor, without rupturing the amniotic sac.
It is to these ends that the present invention has been
developed.
SUMMARY OF THE INVENTION
[0010] To minimize the limitations in the prior art, and to
minimize other limitations that will be apparent upon reading and
understanding the present specification, the present invention
describes a system and method for child-bearing monitoring and
assistance.
[0011] Generally, the invention involves systems, apparatus, and
methods for child-bearing monitoring and assistance but more
specifically, a system, apparatus, and method for monitoring and
measuring a condition inside the uterus without rupturing the
amniotic sac, which in exemplary embodiments employs a pressure
sensing module for use with a single or multi-balloon catheter. The
single or multi-balloon catheter may be coupled to the pressure
sensing module so that a chamber within the pressure-sensing module
is in fluid communication with a balloon of the catheter. The
chamber includes an impermeable pressure-sensing membrane in
communication with a sensor or sensing circuitry. The sensor or
sensing circuitry is configured to detect a condition, for example
a pressure, applied to the impermeable pressure-sensing membrane
and communicate the condition to a monitor of the system. Methods
include inserting the catheter through a cervix so that the balloon
may be inflated and situated in the lower segment of the uterus,
resting against the amniotic sac. Because the balloon of the
catheter is in fluid communication with the impermeable
pressure-sensing membrane, pulsations of the amniotic sac will be
sensed by the sensing circuitry of the pressure sensing module. In
this way, a change in intrauterine pressure during labor may be
evaluated and monitored without rupturing the amniotic sac.
[0012] A system, in accordance with the present invention, for
monitoring and measuring a change in intrauterine pressure during
labor without rupturing the amniotic sac, may comprise: a catheter
configured for manipulation by an operator, the catheter including:
a distal end adapted to be placed at least partially inside a
cervix of a patient; a uterine balloon situated substantially at
the distal end of the catheter adapted to be placed at least
partially inside a lower segment of a uterus of the patient; a
first port situated at the proximate end of the catheter; a second
port situated at the proximate end of the catheter; and a conduit
fluidly communicating the first port and the second port to an
interior of the uterine balloon, wherein the uterine balloon is
inflated by introducing a fluid through the first port; and a
pressure sensing module coupled to the second port, the pressure
sensing module including an enclosure having a chamber in fluid
communication with the uterine balloon via the conduit, a
pressure-sensing membrane coupled to the chamber, and a sensing
circuitry coupled to the pressure-sensing membrane configured to
detect a pressure applied to the uterine balloon of the
catheter.
[0013] A pressure sensing module, in accordance with the present
invention, for monitoring and measuring a change in intrauterine
pressure during labor without rupturing the amniotic sac, may
include: an enclosure configured to couple to a first port of a
catheter, the catheter including: a distal end adapted to be placed
at least partially inside a cervix of a patient; a uterine balloon
situated substantially at the distal end of the catheter adapted to
be placed at least partially inside a lower segment of a uterus of
the patient; a second port situated at the proximate end of the
catheter; and a conduit fluidly communicating the first port and
the second port to an interior of the uterine balloon, wherein the
uterine balloon is inflated by introducing a fluid through the
first port; a chamber within the enclosure including a chamber port
adapted for fluid communication with the uterine balloon via the
conduit; a pressure-sensing membrane coupled to the chamber; and a
sensing circuitry coupled to the pressure-sensing membrane
configured to detect a pressure applied to the uterine balloon of
the catheter.
[0014] A method, in accordance with practice of the present
invention, for monitoring and measuring a change in intrauterine
pressure during labor without rupturing the amniotic sac, may
include the steps of: coupling a pressure sensing module to a
catheter; inserting the catheter into a vagina and through a
cervical canal of a female patient, wherein: a distal end of the
catheter is placed inside the cervical canal, and a proximal end of
the catheter is kept outside the cervical canal, the catheter
including: a uterine balloon in fluid communication with the
proximal end and attached at or near the distal end of the
catheter, a first port situated at the proximate end of the
catheter, a second port situated at the proximate end of the
catheter, a conduit fluidly communicating the first port and the
second port to an interior of the uterine balloon, and a vaginal
balloon situated closer to the proximate end of the catheter than
the uterine balloon and adapted to secure the uterine balloon
inside the uterus; positioning the uterine balloon at a lower
segment of a uterus of the female patient; inflating the uterine
balloon from the proximal end and through the catheter by
introducing a fluid through a first port of the catheter so that
the fluid inflates the balloon and enters a first chamber of the
sensing module; positioning the vaginal balloon at an external OS
of the cervical canal of the female patient; inflating the vaginal
balloon to anchor the uterine balloon inside the lower segment of
the uterus so that the uterine balloon rests against an amniotic
sac of the female patient; and reading a pressure output from the
pressure sensing module.
[0015] Various objects and advantages of the present invention will
become apparent from the following description taken in conjunction
with the accompanying drawings wherein are set forth, by way of
illustration and example, certain embodiments of this invention.
The drawings submitted herewith constitute a part of this
specification, include exemplary embodiments of the present
invention, and illustrate various objects and features thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Elements in the figures have not necessarily been drawn to
scale in order to enhance their clarity and improve understanding
of the various embodiments of the invention. Furthermore, elements
that are known to be common and well understood to those in the
industry are not depicted in order to provide a clear view of the
various embodiments of the invention.
[0017] FIG. 1 is a schematic diagram of the women's reproductive
system during pregnancy.
[0018] FIG. 2 illustrates an inflatable system in accordance with
the present invention.
[0019] FIG. 3A illustrates an example of possible arrangements for
fluid communication from a proximate end to a distal end of an
inflatable system in accordance with the present invention.
[0020] FIG. 3B illustrates an example of possible arrangements for
fluid communication from a proximate end to a distal end of an
inflatable system in accordance with the present invention.
[0021] FIG. 3C illustrates an example of possible arrangements for
fluid communication from a proximate end to a distal end of an
inflatable system in accordance with the present invention.
[0022] FIG. 3D illustrates an example of possible arrangements for
fluid communication from a proximate end to a distal end of an
inflatable system in accordance with the present invention.
[0023] FIG. 4 illustrates an exemplary inflatable system in
accordance with the present invention, shown inside a woman's
reproductive system.
[0024] FIG. 5 illustrates an exemplary system in accordance with
some embodiments of the present invention that employs a pressure
sensing module coupled to a one-balloon catheter.
[0025] FIG. 6A illustrates an exemplary system in accordance with
some embodiments of the present invention that employs a pressure
sensing module coupled to a multi-balloon catheter.
[0026] FIG. 6B-6D illustrate an exemplary stylet that may be
implemented with some exemplary embodiments of a catheter in
accordance with the present invention, which includes a tubular
support for facilitating the introduction of other instruments
through the catheter.
[0027] FIG. 7 illustrates a block diagram of an exemplary system
employing a pressure sensing module in accordance with some
embodiments of the present invention.
[0028] FIG. 8A illustrates an exemplary pressure sensing module in
accordance with some embodiments of the present invention.
[0029] FIG. 8B illustrates an exemplary pressure sensing module in
accordance with some embodiments of the present invention.
[0030] FIG. 8C illustrates an exemplary pressure sensing module in
accordance with some embodiments of the present invention.
[0031] FIG. 9 illustrates an exemplary multi-balloon catheter
system in accordance with the present invention, shown inside a
woman's reproductive system.
[0032] FIG. 9A illustrates an exemplary method in accordance with
practice of the present invention.
[0033] FIG. 10 illustrates an exemplary method in accordance with
practice of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0034] In the following discussion that addresses a number of
embodiments and applications of the present invention, reference is
made to the accompanying drawings, which form a part thereof.
Depictions are made, by way of illustration, of specific
embodiments in which the invention may be practiced; however, it is
to be understood that other embodiments may be utilized, and
changes may be made without departing from the scope of the present
invention. Wherever possible, the same reference numbers are used
in the drawings and the following description to refer to the same
or similar elements.
[0035] In the following detailed description, numerous specific
details are set forth by way of examples in order to provide a
thorough understanding of the relevant teachings. However, it
should be apparent to those skilled in the art that the present
teachings may be practiced without such details. In other
instances, well-known structures, components, and/or functional or
structural relationship thereof, etc., have been described at a
relatively high level, without detail, in order to avoid
unnecessarily obscuring aspects of the present teachings.
[0036] Throughout the specification and claims, terms may have
nuanced meanings suggested or implied in context beyond an
explicitly stated meaning. Likewise, the phrase "in one
embodiment/example," as used herein, does not necessarily refer to
the same embodiment, and the phrase "in another
embodiment/example," as used herein, does not necessarily refer to
a different embodiment. It is intended, for example, that the
claimed subject matter include combinations of example embodiments
in whole or in part.
[0037] Conditional language used herein, such as, among others,
"can," "could," "might," "may," "e.g.," and the like, unless
specifically stated otherwise, or otherwise understood within the
context as used, is generally intended to convey that certain
embodiments include, while other embodiments do not include,
certain features, elements, and/or steps. Thus, such conditional
language is not generally intended to imply that features,
elements, and/or steps are in any way required for one or more
embodiments, whether these features, elements, and/or steps are
included or are to be performed in any particular embodiment.
[0038] The terms "comprising," "including," "having," and the like
are synonymous and are used inclusively, in an open-ended fashion,
and do not exclude additional elements, features, acts, operations,
and so forth. Also, the term "or" is used in its inclusive sense
(and not in its exclusive sense) so that when used, for example, to
connect a list of elements, the term "or" means one, some, or all
of the elements in the list. Conjunctive language such as the
phrase "at least one of X, Y, and Z," unless specifically stated
otherwise, is otherwise understood with the context as used in
general to convey that an item, term, etc., may be either X, Y, or
Z. Thus, such conjunctive language is not generally intended to
imply that certain embodiments require at least one of X, at least
one of Y, and at least one of Z to each be present.
[0039] The term "and/or" means that "and" applies to some
embodiments and "or" applies to some embodiments. Thus, A, B,
and/or C can be replaced with A, B, and C written in one sentence
and A, B, or C written in another sentence. A, B, and/or C means
that some embodiments can include A and B, some embodiments can
include A and C, some embodiments can include B and C, some
embodiments can include only A, some embodiments can include only
B, some embodiments can include only C, and some embodiments can
include A, B, and C. The term "and/or" is used to avoid unnecessary
redundancy. Similarly, terms such as "a," "an," or "the," again,
may be understood to convey a singular usage or to convey a plural
usage, depending at least in part upon context. In addition, the
term "based on" may be understood as not necessarily intended to
convey an exclusive set of facts and may, instead, allow of the
existence of additional factors not necessarily expressly
described, again, depending at least in part on context.
[0040] While exemplary embodiments of the disclosure may be
described, modifications, adaptations, and other implementations
are possible. For example, substitutions, additions, or
modifications may be made to the elements illustrated in the
drawings, and the methods described herein may be modified by
substituting, reordering, or adding stages to the disclosed
methods. Thus, nothing in the foregoing description is intended to
imply that any particular feature, characteristic, step, module, or
block is necessary or indispensable. Indeed, the novel methods and
systems described herein may be embodied in a variety of other
forms; furthermore, various omissions, substitutions, and changes
in the form of the methods and systems described herein may be made
without departing from the spirit of the invention or inventions
disclosed herein. Accordingly, the following detailed description
does not limit the disclosure. Instead, the proper scope of the
disclosure is defined by the appended claims.
[0041] Generally, the invention involves systems, apparatus, and
methods for monitoring and measuring a condition inside the uterus
without rupturing the amniotic sac, which in exemplary embodiments
employs a pressure sensing module for use with a single or
multi-balloon catheter. Coupled to the catheter, a pressure sensing
module is configured with a plurality of chambers wherein at least
a first of the plurality of chambers is adapted to receive a fluid
that is applied via a catheter port and wherein at least a second
of the plurality of chambers is adapted to contain air or another
fluid separated from the first chamber by a membrane. A sensor
coupled to the second chamber may be configured to detect a change
in pressure applied to the membrane in order to communicate the
pressure change to, for example, a pressure monitor of the
system.
[0042] In some exemplary embodiments of the present invention, a
system for inducing labor may include: a catheter with at least
one, two or three balloons (or more) inflatable balloons that are
configured to keep the system in an exact position within woman's
reproductive system, monitor and/or control pressures inside
uterus, exert controllable pressure on the cervical canal walls,
stimulate cervical canal, monitor pressures inside cervical canal,
and, if desired, administer pharmaceutical substances and/or
rupture an amniotic sac.
[0043] In some exemplary embodiments of the present invention, a
uterine balloon may be positioned at a proximal portion of the
uterus, with respect to an operator, adjacent to the cervical
internal orifice of the uterus (internal OS). In some embodiments,
the uterine balloon may have different shapes so as to, for
example, maximize the pressure against the decidua and the external
orifice of the uterus (external OS) and to minimize the pressure on
the fetal head. In other embodiments, the uterine balloon may have
different surface roughness, for example, for anchoring the uterine
balloon in place.
[0044] In some exemplary embodiments of the present invention, the
system may optionally or additionally include a vaginal balloon for
positioning in the vagina for applying pressure on the external OS.
The combination of a uterine balloon and a vaginal balloon may
stabilize the position of the inflatable system within the woman's
reproductive system as long as both balloons are inflated.
[0045] In some exemplary embodiments of the present invention, the
system may optionally or additionally include a cervical balloon
for positioning in the cervical canal, shaped so as to maximize the
contact area with the cervix. The shape and the surface roughness
of the cervical balloon may also be designed in order to maximize
cervix contact and stimulation.
[0046] In exemplary embodiments, the one or more balloons of the
system may stimulate the secretion of hormone by exerting pressure
on the proximal decidual surfaces of the uterus and on the cervix,
to soften and ripen the cervix, to cause the cervix to dilate, and
to induce labor. The balloons, which in some embodiments 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 patient.
[0047] In some exemplary embodiments of the present invention,
various sensors and instruments may be used as part of the system
to monitor cervical dilation, fetal well-being, and the woman's
conditions. In some embodiments, pharmaceutical substances may also
be applied to the cervix canal through a cervical canal portion of
the disclosed device.
[0048] Turning now to the figures, FIG. 1 is a schematic diagram of
the women's reproductive system during pregnancy. More
specifically, FIG. 1 illustrates a woman's reproductive system 100
during pregnancy, showing a vagina 112, a cervix 116 forming a
cervical canal 114, an ectocervix or external OS 115, an internal
OS 117, a uterus 118, an endometrium 121 which is the mucous
membrane lining the uterus 118, an amniotic sac 125 containing a
fetus 127 having a head 129, and a decidua 123 which is the mucous
membrane lining the uterus 118 in preparation for, and during
pregnancy.
[0049] Turning now to the next figures, FIG. 2 illustrates an
inflatable system in accordance with the present invention. More
specifically, FIG. 2 schematically illustrates an embodiment of
system 200 for cervical dilation, labor induction and uterus and
cervical canal pressure monitoring and control. As seen in FIG. 2,
system 200 includes a catheter 210 having a proximal end 220 and a
distal end 230, with respect to an operator, wherein the distal end
230 enters a woman's reproductive system and the proximal end 220
remains outside her body to be manipulated by an operator/medical
staff.
[0050] In some exemplary embodiments, catheter 210 may include: (1)
a uterine balloon 240 substantially at the distal end 230 and a
conduit/tube (not shown) inside the catheter 210, spanning from the
proximal end 220 to the distal end 230 and in fluid communication
with the uterine balloon 240. In some exemplary embodiments, the
catheter 210 may also include a cervical balloon 250, in fluid
communication with a cervical-balloon conduit/tube (not shown)
inside the catheter 210, spanning from the proximal end 220 to the
distal end 230.
[0051] As seen in FIG. 2, the location of the cervical balloon 250
on the catheter 210 is closer to catheter's proximal end 220 than
the location of the uterine balloon 240 is. The catheter 210 is
designed for insertion into the woman's reproductive system, so
that the cervical balloon 250 is positioned and inflated within the
cervical canal 114. The cervical balloon 250 is designed for
applying pressure on the cervix 116. It will be appreciated that
the pressure on the cervix 116 may further include pressure on the
internal OS 117 and on the external OS 115.
[0052] In some embodiments, the inflatable system 200 may include a
vaginal balloon 260, in fluid communication with a vaginal-balloon
conduit/tube (not shown) inside the catheter 210, spanning from the
proximal end 220 to the distal end 230. The vaginal balloon 260 is
adapted for positioning within the vagina 1 12, at a distal portion
thereof, for pressing against the external cervical OS 115. The
one, two or three-balloons of system 200, from catheter 210's
distal end 230, may be inserted into a woman's reproductive system
100, prior to inflation of the balloons.
[0053] In an exemplary three-balloon inflatable system 200, the
uterine balloon 240 and the vaginal balloon 260 are partly
operative to anchor the cervical balloon 250 in place and to
enhance hormonal secretion by applying pressure on the decidual
123, the internal OS 117, and the external OS 115. At the same
time, the cervical balloon 250, anchored within the cervical canal
114, may accelerate cervical dilation, by applying pressure on the
cervix 116, and preferably also, the internal OS 117 and on the
external OS 115.
[0054] In various embodiments the inflatable system 200 may also
have openings, such as opening 255, which is in fluid communication
with a conduit/tube (not shown) inside the catheter 210, spanning
from the proximal end 220 to the distal end 230. Opening 255 is
situated on the catheter 210 such that, for example, upon placement
in a woman's reproductive system the opening 255 is positioned
within the cervical canal 114 and is used to insert pharmaceutical
substances into the cervical canal 114.
[0055] In accordance with the present invention, the inflation of
the balloons of the inflatable system 200 may be performed by a
doctor or a midwife (not shown) directly after its insertion. In
some exemplary embodiments, the inflation of the balloons of the
inflatable system 200 may be performed by the patient via a hand
pump 270, in a gradual manner, for example over several hours.
Alternatively still, uterine balloon 240 and or vagina balloon 260
may be inflated by the doctor or midwife, while the inflation of
the cervical balloon 250 may be performed by the patient, for
example, via a hand pump 270. Without limiting the scope of the
present invention, pump 270 in FIG. 2 represents any kind of manual
or automatic gas or fluid pump suitable for inflating the one or
more balloons of catheter 210 of system 200.
[0056] Having a pressure sensor at the distal end of the inflatable
instrument, inside the uterus and/or cervix canal, has some
limitations and disadvantages including: (1) the pressure sensor
must be small enough, such as a few millimeters, to fit and/or move
inside the instrument, which has to pass through the cervix canal;
(2) the pressure sensor must be disposable since the entire
intracorporeal part of the system needs to be discarded after use;
(3) the sensed pressures need to be transmitted outside the woman's
body for recording or display, by wire or wirelessly; and (4) the
system will be more expensive and bulkier as a result of the
mentioned limitations and disadvantages.
[0057] Accordingly, a system for labor induction and
monitoring/control in accordance with the present invention will be
much smaller, less expensive and simpler if the pressures inside
the uterus and/or cervical canal can be transferred to one or more
sensors situated outside the woman's body. To do so, a very simple
and instantaneous transfer of pressure is possible by using gasses
and fluids. However, pressure transfer through a gaseous medium is
not as accurate as through incompressible fluids since gasses are
compressible and their compressibility varies by temperature and
pressure, which introduce undesirable variables into the sensing
subsystem. On the other hand, pressure may be accurately sensed at
any point of a fluid body without any erroneous effect from the
surrounding variables. Therefore, the preferred embodiment of this
specification inflates, at least, the uterine balloon by nontoxic
incompressible fluids such as water.
[0058] In the uterus, as a result of hydraulic principles, the
pressure inside the fluid-filled uterine balloon will rapidly come
to static equilibrium with the pressures of the amniotic sac and
the uterus walls. At such stage, the pressure of the amniotic
fluid, the uterine balloon fluid and the pressure on the uterus
walls are equal. Hence a sensor outside the woman's body and in
fluid contact with the uterine balloon will sense the exact
pressure of the uterus/amniotic fluid. The uterus/amniotic fluid
pressure may be controllably increased or decreased by inflating or
deflating the uterine balloon, respectively. While inflating or
deflating the uterine balloon, the exact pressure inside the uterus
may also be sensed and observed. With fluid, no wait time is
required for pressure equilibrium. A pressure sensing module that
may be used with system 200 or other systems in accordance with
exemplary embodiments of the present invention, is discussed
further below with reference to FIG. 5, FIG. 6A, FIG. 7, and FIGS.
8A-8C.
[0059] The same is true about a cervical balloon and the monitoring
and control of the cervix pressures. In some embodiments, the fluid
inside the cervical canal balloon may even be pulsated to further
stimulate the canal walls. The pulsation may be caused manually or
mechanically. Here also, the cervical balloon itself may be a
combination of multiple balloons which may be inflated separately
or as a group.
[0060] The inflation/deflation of multiple balloons may be
controlled together or independently to allow stimulation of the
cervical canal with variable pressures across both time and
position within the cervical canal. Such an arrangement may be used
to create a pressure signal, varying over time and space, to
stimulate different regions within the canal at different pressures
and at different times, which may be helpful in stimulating
dilation more effectively.
[0061] For example, if two balloons are employed, their inflation
and deflation may be alternated to create a two-point variable
pressure signal. In some embodiments, the inflatable system 200 may
be coupled with a pressure controller to automatically inflate and
deflated the multiple balloons according to a predefined signal
pattern chosen by the operator. For example, the pressure
controller may have several settings such as sinusoidal pattern,
ramped inflation/deflation, and pulsed/rapid inflation/deflation,
each of which may be selected by the operator to inflate and
deflate the balloons accordingly for different types of
stimulation. In multiple balloon embodiments, each balloon may need
its own separate micro-tube for independent inflation/deflation, in
which the micro-tubes pass through a larger outer tube to allow
easy handling and control of the inflatable system, in a manner
similar to those shown in FIGS. 3A-3D discussed below.
[0062] In general, a vaginal balloon in accordance with the present
invention need not be inflated by fluid because it is usually not
used to sense or control any pressure; however, if fluid is used to
inflate the other balloons, it may be easier to do the same with
the vaginal balloon. The vaginal balloon may also consist of more
than one balloon controlled as a group or separately in a manner
similar to the cervical canal balloons described above.
[0063] In exemplary embodiments, at least one of the balloons is
inflated by fluid such as water to accurately measure and control
the pressure of its surrounding. An increase or decrease of the
size of the balloons will increase or decrease, respectively, the
pressure of their environment which at the same time can be
measured. For example, a small fluid inflation of the uterine
balloon 240 enables an accurate measurement of the uterus and
amniotic fluid pressures while any increase in the uterine balloon
size will increase the uterus and amniotic fluid pressures. Same is
true with cervical canal pressure measurement and control. Usually
there is no need for measurement and/or control of vaginal pressure
and therefore the vaginal balloon may be inflated by air instead of
a fluid.
[0064] FIG. 2, shows an example system 200 with four connection
ports 280, 282, 284, and 286, to which gas and fluid pumps, sensors
and gauges, and other instruments may be attached. Each port may be
of different kind and use different operating mechanisms. For
example, connection port 280 may be closed in its unattached state
and be open as long as being connected to any device. Or, for
example, port 286 may have a manually operated valve 288.
[0065] Therefore, connection port 280, which in this example is
assumed to be in fluid communication with uterine balloon 240, may
first be connected to a pressure gauge 290 and a fluid pump 270
until the uterine balloon 240 is inflated to a desired pressure or
size and subsequently be disconnected from the pump, if needed. In
such a case, the uterus pressures can be continuously monitored. If
constant monitoring of the pressure is not needed, both the
pressure gauge 290 and the fluid pump 270 may be removed and the
pressure of uterus be checked at the connection port 280 whenever
desired. In some embodiments, the conduit/tube connecting
connection port 280 to uterine balloon 240 may even have a separate
dedicated port for connecting to sensors and gauges. In yet another
example, connection port 280 may be attached to an automated
machine for monitoring and/or controlling the pressure of the
uterus. In various embodiments, dedicated monitoring ports for each
balloon may be connected to a monitoring device(s) while ports,
such as port 280, are dedicated to injection, manipulation and/or
pumping devices. In these embodiments the pumping device can be a
mere syringe 281. There is no need for complicated pumping devices
with pressure gauge. Assuming that connection port 284 is in fluid
communication with cervical balloon 250, it can be connected to a
fluid pulsating device that is capable of controlled fluid
pulsation with desired low and high pressures.
[0066] If fluid is used to inflate the balloons, there are several
ways to eliminate the air in the conduits/tubes. In one embodiment
the conduits and the balloons of the system 200 may be manufactured
in a collapsed or vacuumed initial form. In other embodiments the
connection ports may provide manual release valves to empty the
trapped air while inserting fluid into the conduits. Such solutions
are known to those skilled in the art and need no further
elaboration.
[0067] As illustrated in FIG. 2, different devices may be used as a
part of such inflatable system 200. In various embodiments the
inflatable system 200 may include at least one additional
conduit/tube (not shown), having at least one opening 235, to the
uterus. The at least one additional conduit/tube is operable for
inserting at least one device 236 to the woman's reproductive
system. In the embodiment of FIG. 2, the at least one additional
tube is operable for inserting the at least one device 236 into the
uterus, via the opening 235. Similarly, another conduit/tube may be
used for inserting another device into the cervical canal, via a
similar opening. In FIG. 2, the at least one device 236 is a device
for rupturing the amniotic sac. Device 236 may be operated as a
plunger-like device, using a handle at the proximal end 220 of the
inflatable system 200. After the puncture, device 236 may be
withdrawn from one of the connection ports.
[0068] In yet other embodiments, the at least one device 236 may be
a sensor, for example, for sensing amniotic-fluid temperature, or
for sensing fetal heart-beat, preferably operable via the opening
235 to the uterus. The measurements may be transmitted
extracorporeally in a wired or wireless manner.
[0069] It will be appreciated that the device 236 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 the like.
[0070] Alternatively, the at least one device 236 may include a
drug form, designed for passive dispensing of a medication. The
drug form may be inserted with a syringe 281, and the syringe 281
may then be withdrawn. 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 235 to the uterus, or via a similar
opening(s) to the cervical canal. Device 236 may be
electronically-controlled, pre-programmed, or may be wirelessly
controlled from an extracorporeal station.
[0071] In yet other embodiments, device 236 may include a device
for measuring an extent of cervical dilation, operable via an
opening to the cervical canal. The measurements may be transmitted
extracorporeally by wire or wirelessly. In various embodiments,
device 236 may be a combination of several devises and/or
sensors.
[0072] FIG. 3A-FIG. 3D illustrate several exemplary embodiments of
conduits for a catheter in accordance with the present invention.
In FIG. 3A, a first tube 310 may include separate conduits 301,
302, and 303 corresponding to separate tubes 311, 312, and 313, all
of which reside within a conduit of tube 310. In exemplary
embodiments, each of tubes 311, 312, and 313 may connect to a
connection port, to a balloon or an opening via their own
respective conduits 301, 302, and 303.
[0073] As will be evident from the following figures, other
configurations of tubes and conduits may be possible without
deviating or limiting the scope of the present invention. In FIG.
3B, tubes 340 and 330 may be nested within tube 320, each of the
tubes providing concentric conduits 341, 331, and 321,
respectively. In other embodiments the arrangement of the tubes may
be a combination of the arrangements in FIGS. 3A and 3B. For
example, and without limiting the scope of the present invention,
FIG. 3C shows tube 350 housing tube 351, which in turn houses
several tubes 352, 353, and 354. FIG. 3D shows yet another
embodiment, in which a single catheter tube may include two smaller
tubes with conduits therein, such as tube 360 housing tube 361 and
tube 362.
[0074] Turning now to the next figure, FIG. 4 depicts a
three-balloon catheter 410 that has been inserted into a woman's
reproductive system 400 and subsequently inflated, so that the
uterine balloon 420 is in contact with the amniotic sac 450 in the
lower segment of the uterus, the cervical balloon 430 is in the
cervical canal, and the vaginal balloon 440 is in the distal end of
the vagina.
[0075] In the example of FIG. 4, the uterine balloon 420 applies
pressure on the decidua and the internal OS. The cervical balloon
430 applies pressure on the cervix walls, and the vaginal balloon
440 applies pressure on the external OS. For withdrawal, the
balloons are deflated.
[0076] As seen from FIG. 4, the uterine balloon 420 is operative
partly to separate the amniotic sac 450 from the decidua in the
lower segment of the uterus, thereby stimulating endogenous hormone
secretion of PG from the decidua. The hormone secretion by the
decidua is operative to soften and ripen the cervical canal and
induce labor. Similarly, the cervical balloon 430 is operative to
stimulate hormone secretion by the cervix. Again, the hormone
secretion is operative to soften and ripen the cervical canal and
induce labor.
[0077] In some embodiments electrocardiogram of the fetus heart may
be obtained by temporarily or permanently attaching a desired type
and number of electrodes on the surface of the uterine balloon 420,
to be directly in contact with the fetus head or indirectly through
the amniotic sac, and to send the sensed signals to an
extracorporeal EKG or ECG machine, by wire or wirelessly. In some
embodiments the electrodes may be a part of or be ingrained in the
material of the uterine balloon 420.
[0078] Turning now to the next figure, FIG. 5 depicts system 500,
which includes a catheter 501 having a proximal end 502 and a
distal end 503, with respect to an operator, wherein the distal end
503 enters a woman's reproductive system and the proximal end 502
remains outside her body to be manipulated by the operator, such as
a physician or medical staff.
[0079] In some exemplary embodiments, catheter 501 may include: a
single balloon 510 that serves as a uterine balloon, substantially
at the distal end 503 of catheter 501; a conduit (not shown) inside
the catheter 510, spanning from the proximal end 502 to the distal
end 503 in fluid communication with balloon 510 via said conduit
with openings 504 and 505; a first port 506 for introducing a fluid
into the balloon 510; and a second port 507 coupled directly to a
pressure sensing module 520. Catheter 501 may include a tip 508
that is blunt so as to not rupture the amniotic sac or may be
alternatively configured to rupture the amniotic sac. The blunt tip
508 may include an opening 509 so that an instrument, such as a
temperature transducer or an imaging transducer, may be provided
access to the lower segment of the uterus and amniotic sac of a
patient via opening 509. Moreover, as will be explained below, in
some exemplary embodiments, pressure sensing module 520 may be
coupled to an external component such as a sensing device or
monitor via communication means 511.
[0080] In exemplary embodiments, system 500 includes a catheter 501
configured for manipulation by an operator, the catheter including:
a distal end 503 adapted to be placed at least partially inside a
cervix of a patient; a balloon 510 situated substantially at the
distal end 503 of the catheter 501 adapted to be placed at least
partially inside a uterus of the patient; a first port 506 situated
at the proximate end of the catheter 501; a second port 507
situated at the proximate end 502 of the catheter 501; and a
conduit fluidly communicating the first port 506 and the second
port 507 to an interior of the balloon 510, wherein the balloon is
inflated by introducing a fluid through the first port 506; and a
pressure sensing module 520 coupled to the second port, the
pressure sensing module 520 including an enclosure having a first
chamber in fluid communication with the conduit, a second chamber
in fluid communication with a sensor, and an pressure-sensing
membrane separating the first chamber from the second chamber,
wherein the pressure sensing module is configured to detect a
pressure applied to the balloon of the catheter.
[0081] In exemplary embodiments of the present invention, the
conduit of the catheter 501 includes: a first conduit communicating
the first port 506 to a first opening 504 on the distal end of the
catheter situated at the interior of the balloon 510; and a second
conduit communicating the second port 507 to a second opening 505
on the distal end of the catheter situated at the interior of the
balloon 510.
[0082] In exemplary embodiments of the present invention, the first
port 506 of the catheter may include a valve configured to prevent
a fluid injected through port 506 and into the conduit that fills
the balloon 510 from returning back out of port 506. Similarly, a
first chamber of pressure sensing module 520 may also include a
valve, such as a check-valve or otherwise sealable valve 521a,
which allows any air inside the chamber to exit the pressure
sensing module as the fluid is received. Once adequately filled, a
user may seal the valve 512a in order to maintain the fluid
within.
[0083] Turning now to the next figure, FIG. 6A a similar exemplary
embodiment as that shown in FIG. 5, comprising a catheter 601 that
may include: a uterine balloon 610 substantially at the distal end
603 and a conduit/tube (not shown) inside the catheter 601,
spanning from the proximal end 602 to the distal end 603 and in
fluid communication with the uterine balloon 610, and a vaginal
balloon 692, in fluid communication with a vaginal-balloon
conduit/tube (not shown) inside the catheter 601, spanning from the
proximal end 602 to the distal end 603. The vaginal balloon 692, is
spaced apparat and situated a distance closer to the proximate end
602 of the catheter 601 so that when catheter 601 is inserted
through the cervix of a patient, balloon 610 may be situated at a
lower segment of the uterus and balloon 693 may be situated outside
of the uterus and against an exterior portion of the cervix
anchoring the balloon at or proximate to the external OS 115 of the
patient (see also FIG. 9 and related discussion below).
[0084] In exemplary embodiments, system 600 includes a catheter 601
configured for manipulation by an operator, the catheter including:
a distal end 603 adapted to be placed at least partially inside a
cervix of a patient; a balloon 610 situated substantially at the
distal end 603 of the catheter 601 adapted to be placed at least
partially inside a uterus of the patient; a first port 606 situated
at the proximate end of the catheter 601; a second port 607
situated at the proximate end 602 of the catheter 601; and a
conduit fluidly communicating the first port 606 and the second
port 607 to an interior of the balloon 610, wherein the balloon is
inflated by introducing a fluid through the first port 606; and a
pressure sensing module 620 coupled to the second port, the
pressure sensing module 620 including an enclosure having a first
chamber in fluid communication with the conduit, the first chamber
including a pressure-sensing membrane in communication with a
sensor (see for example FIG. 7, or FIGS. 8A-8C), wherein the
pressure sensing module is configured to detect a pressure applied
to the uterine balloon 610 of the catheter 601. In exemplary
embodiments of the present invention, the first port 606 of the
catheter may include a valve configured to prevent a fluid injected
through port 606 and into the conduit that fills the balloon 610
from returning back out of port 606. Similarly, a first chamber of
pressure sensing module 620 may also include a valve, such as a
check-valve or otherwise sealable valve 621a, which allows any air
inside the chamber to exit the pressure sensing module as the fluid
is received. Once adequately filled, a user may seal the valve 621a
in order to maintain the fluid within.
[0085] As seen in FIG. 6A, the location of the vaginal balloon 692
on the catheter 610 is closer to catheter's proximal end 603 than
the location of the uterine balloon 610 is. The vaginal balloon 692
is adapted for positioning within the vagina 112, at a distal
portion thereof, for pressing against the external cervical OS 115.
The distal portion of the two-balloon catheter of system 600 in
such embodiment, from catheter 601's distal end 602, may be
inserted into a woman's reproductive system 100, prior to inflation
of the balloons.
[0086] In an exemplary two-balloon inflatable system 600, the
vaginal balloon 692 is at least partly operative to anchor the
uterine balloon 692 in place. That is, vaginal balloon 692 will
help stabilize uterine balloon 610 so that uterine balloon 610 may
rest securely against an unruptured amniotic sac of the patient. In
this way, more accurate readings may be obtained. More
specifically, when uterine balloon is filled and placed against an
unruptured amniotic sac, a pressure change within the unruptured
amniotic sac may be detected via the pressure sensing module since
any change in pressure within the unruptured amniotic sac will be
transferred to the uterine balloon, which is in fluid communication
with a pressure sensing membrane of the pressure sensing module 620
(see also FIG. 7). Moreover, as with previously discussed exemplary
embodiments, pressure sensing module 620 may be coupled to an
external component such as a sensing device or monitor via
communication means 611.
[0087] In various embodiments, the inflatable system 600 may also
have openings, such as opening 688, which is in fluid communication
with a conduit/tube (not shown) inside the catheter 601, spanning
from the proximal end 602 to the distal end 603. Opening 688 is
situated on the catheter 610 such that, for example, upon placement
in a woman's reproductive system the opening 688 is positioned
within the cervical canal 114 and is used to insert pharmaceutical
substances into the cervical canal 114. Similarly, catheter 601 may
include a tip 608 that is blunt so as to not rupture the amniotic
sac or may be alternatively configured to rupture the amniotic sac.
The blunt tip 608 may include an opening 609 so that an instrument,
such as a temperature transducer or an imaging transducer, may be
provided access to the lower segment of the uterus and amniotic sac
of a patient via opening 609.
[0088] In accordance with the present invention, the inflation of
the balloons of the inflatable system 600 may be performed by a
doctor or a midwife (not shown) directly after its insertion.
Alternatively, the inflation of the balloons of the inflatable
system 600 may be performed by the patient via a hand pump, in a
gradual manner, for example over several hours. Without limiting
the scope of the present invention, a pump may include any kind of
manual or automatic gas or fluid pump suitable for inflating the
one or more balloons of catheter 610 of system 600.
[0089] As a person of ordinary skill in the art will appreciate,
several conduits within catheter 601 will facilitate the inflation
of the vaginal and uterine balloons, as well as the introduction of
devices such as a stylet and or instruments that may be desirably
introduced through the catheter. For example, and without limiting
the scope of the present invention, catheter 601 may include (in
addition to the ports mentioned above) several ports 693, 694, and
695. In order to inflate balloon 692, a port 693 may be employed.
Furthermore, in order to guide catheter 601 into the desired
position, another port 694 may be implemented for inserting a
stylet (not shown here but see for example FIGS. 6B-6E). Similarly,
an additional port 695 may be used in embodiments in which opening
688 is included in order to provide a means for supplying a
pharmaceutical or therapeutic agent via said port 695 through
opening 688.
[0090] Turning now to the next set of figures, FIGS. 6B-6D
illustrate an exemplary stylet that may be implemented with some
exemplary embodiments of a catheter in accordance with the present
invention, which includes a tubular support for facilitating the
introduction of other instruments through the catheter. More
specifically, these figures show stylet 650, which includes a
handle 651 and a substantially hollow tubular support 652 coupled
to stylet 650 via at least one detachable arm 653. The hollow
tubular support 652 may be detached or broken off from stylet 650,
typically by pressure applied by the operator. It is supposed that
braking away the stylet leaves the tubular support inside a conduit
of the catheter in order to provide support so that opening 609 may
be kept accessible to other devices. As mentioned above, other
devices may include a temperature transducer or an imaging
transducer, which may be provided access to the lower segment of
the uterus and amniotic sac of a patient via opening 609. As
illustrated in this set of figures, FIG. 6B shows stylet 650
outside of a conduit of catheter 601; FIG. 6C shows stylet 650
inside the conduit and facilitating a positioning of the tubular
support 652 within the conduit; and FIG. 6D shows how once within a
desired region (for example a region 610a that may support uterine
balloon 610), arms 653 may be broken or snapped off from the
tubular support in order to remove stylet 650 and leave the tubular
support 652 inside the conduit of catheter 601.
[0091] Turning now to the next figure, FIG. 7 illustrates a block
diagram of an exemplary system employing a pressure sensing module
in accordance with some embodiments of the present invention. More
specifically, FIG. 7 depicts system 700 in accordance with some
exemplary embodiments of the present invention, which is configured
to assist an operator in evaluating an intrauterine pressure during
labor before rupturing the amniotic membrane. In some exemplary
embodiments, system 700 comprises a catheter 701 having at least
one balloon--a uterine balloon 702--in fluid communication with a
fluid chamber 703 of a pressure-sensing module 720. The fluid
chamber 703 exemplarily includes an impermeable pressure-sensing
membrane 704 situated within an enclosure 705 that houses fluid
chamber 703. A port 706 of the pressure sensing module 720
communicates a conduit 701c of catheter 701 that fluidly connects
balloon 702 to fluid chamber 703. A sensing circuitry 707 is
coupled to pressure-sensing membrane 704 and configured to detect a
change in pressure applied to balloon 702.
[0092] In exemplary embodiments, sensing circuitry 707 typically
includes a sensor module 708, a microcontroller 709 having a memory
710 that includes a set of executable instructions for reading
sensing data from the sensor module 708, a communications module
711 for transmitting the sensing data to a remote device having a
transceiver 712 or directly to a monitor via monitor interface 713,
and a power module 714 to supply power to the components of sensing
circuitry 707.
[0093] In some exemplary embodiments, sensor module 708 may
comprise one or more sensors adapted to generate sensing signals
concerning a pressure applied to the uterine balloon 702 via
sensing a change in pressure applied to pressure-sensing membrane
704. The sensors may include optical sensors, strain gauges,
capacitive sensors, Hall Effect sensors, and the like, and may
measure stress and/or strain and/or deflection of the
pressure-sensing membrane 704.
[0094] As may be appreciated from the block diagram, because
uterine balloon 702 of catheter 701 is in fluid communication with
the pressure-sensing membrane 704, a pressure or force F.sub.p
applied to uterine balloon 702 will be transferred to
pressure-sensing membrane 704. Accordingly, pulsations of the
amniotic sac will be sensed by the sensing circuitry of the
pressure sensing module. In this manner, changes in the
intrauterine pressure of a patient in labor may be monitored before
rupturing the amniotic sac. As briefly mentioned above, an
advantage of monitoring intrauterine pressure without rupturing the
amniotic sac is a decrease in the risk of intrauterine infections
for the mother and fetus during labor that is typically associated
with prematurely rupturing the amniotic sac. Moreover, this allows
for improved recording of the number of contractions and
contraction patters. Further, use of system 700 may further cause
the cervix to be diluted and ripen.
[0095] In some exemplary embodiments of the present invention,
system 700 may include: a catheter 701 configured for manipulation
by an operator, the catheter 701 including: a distal end adapted to
be placed at least partially inside a cervix of a patient; a
uterine balloon 702 situated substantially at the distal end of the
catheter 701 adapted to be placed at least partially inside a lower
segment of a uterus of the patient; a port 701a situated at a
proximate end of the catheter 701; a port 701b situated also at the
proximate end of the catheter; and a conduit 701c fluidly
communicating port 701a and port 701b to an interior of the uterine
balloon 702, wherein the uterine balloon 702 is inflated by
introducing a fluid through the port 701a; and a pressure sensing
module 720 coupled to port 701b, the pressure sensing module
including an enclosure 705 having a fluid chamber 703 in fluid
communication with the uterine balloon 702 via the conduit 701c, a
pressure-sensing membrane 704 coupled to the fluid chamber 703, and
optionally a sensing circuitry 707 coupled to the pressure-sensing
membrane 704 configured to detect a pressure applied to the uterine
balloon of the catheter. In some exemplary embodiments, the sensing
circuitry is external to pressure sensing module 720 (so that the
sensing circuitry is housed separately). In some exemplary
embodiments, the sensing circuitry is integral with the
pressure-sensing module 720 so that the sensing circuitry is housed
together with the other components of pressure-sensing module 720,
for example wherein enclosure 705 of pressure-sensing module 720
includes a second chamber that houses sensing circuitry 707.
[0096] In some exemplary embodiments of the present invention, a
pressure sensing module 720 may include: an enclosure 705
configured to couple to port 701b of a catheter 701, wherein the
catheter 701 includes: a distal end adapted to be placed at least
partially inside a cervix of a patient; a uterine balloon 702
situated substantially at the distal end of the catheter adapted to
be placed at least partially inside a uterus of the patient; a port
701a and a port 701b situated at the proximate end of the catheter
701; and a conduit 701c fluidly communicating ports 701a and 701b
to an interior of the uterine balloon 702, wherein the uterine
balloon 702 is inflated by introducing a fluid through the port
701a. The enclosure 705 houses fluid chamber 703 within the
enclosure 705 and includes chamber port 706 adapted to couple with
port 701b for achieving fluid communication between fluid chamber
703 and the uterine balloon 702 via the conduit 701c. In exemplary
embodiments of the present invention, the port 701a of catheter 701
may include a valve (not shown) configured to prevent a fluid
injected through port 701a and into the conduit 701c that fills the
balloon 702 from returning back out of port 701a. Similarly, fluid
chamber 703 of enclosure 705 may also include a valve, such as a
check-valve or otherwise a sealable valve 705a, which allows any
air inside fluid chamber 703 to exit as the fluid is received
therein. Once adequately filled, a user may seal the valve 705a in
order to maintain the fluid within fluid chamber 703, conduit 701c,
and balloon 702.
[0097] Moreover, pressure-sensing module 720 includes a
pressure-sensing membrane 704 coupled to the fluid chamber 703, and
a sensing circuitry 707 coupled to or in communication with the
pressure-sensing membrane 703, said sensing circuitry 707
configured to detect a pressure applied to the uterine balloon 702
of the catheter 701.
[0098] Now turning to the next set of figures, FIG. 8A illustrates
an exemplary pressure sensing module 820 in accordance with some
exemplary embodiments of the present invention. In the shown
embodiment, the pressure sensing module 820 includes an enclosure
821 having a valve 821a, first chamber 822 in fluid communication
with the conduit 829, a second chamber 823 in fluid communication
with a sensor 826, and an pressure-sensing membrane 824 separating
the first chamber 822 from the second chamber 823, wherein the
pressure sensing module 820 is configured to detect a pressure
applied to the balloon 810 of the catheter 801. In some exemplary
embodiments, such as the one depicted in FIG. 8A, the second
chamber 822 of the pressure sensing module 820 houses a second
fluid that is distinct from the fluid introduced through the first
port 806 into the first chamber 822. In some exemplary embodiments,
the fluid in the second chamber 823 is a gas or a liquid. In some
exemplary embodiments, a gas in the second chamber may be simply
air. In some exemplary embodiments, the fluid introduced through
the first port 806 into the first chamber 822 is water or a
nontoxic liquid.
[0099] Now turning to the next figure, FIG. 8B illustrates pressure
sensing module 820 in accordance with some exemplary embodiments of
the present invention. In embodiments such as the one depicted in
this figure, a pressure sensing module 820 for monitoring and
measuring a change in intrauterine pressure during labor, without
rupturing the amniotic sac, may include an enclosure 821 configured
to couple to a first port 807 of a catheter 801, the catheter 801
including: a distal end 803 adapted to be placed at least partially
inside a cervix of a patient; a balloon 810 situated substantially
at the distal end 803 of the catheter adapted to be placed at least
partially inside a uterus of the patient; a second port 806
situated at the proximate end 802 of the catheter 801; and a
conduit fluidly communicating the second port 806 and the first
port 807 to an interior of the balloon 801, wherein the balloon 801
is inflated by introducing a fluid through the second port 806; a
first chamber 822 housed within the enclosure 821 and in fluid
communication with the conduit; a second chamber 823 housed within
the enclosure 821 and in fluid communication with a sensor 826; and
an pressure-sensing membrane 824 separating the first chamber 822
from the second chamber 823, wherein the sensor 826 is configured
to detect a pressure applied to the balloon 810 of the catheter
801. In the shown embodiments, air that may be occupying chamber
822 prior to a liquid being introduced, may be ejected out of
chamber 822 via a valve 821a.
[0100] In some exemplary embodiments, the pressure sensing module
820 may include a second chamber 823 that houses a second fluid
that is distinct from the fluid introduced through the second port
806 into the first chamber 822. In some embodiments, the fluid in
the second chamber 823 is a gas or a liquid. In some exemplary
embodiments, the gas in the second chamber 823 is air.
[0101] In some exemplary embodiments, the enclosure 821 of the
pressure sensing module 820 includes a third chamber 825 for
housing the sensor 826. In some exemplary embodiments, the
enclosure 821 is removably coupled to the sensor 826, wherein the
sensor 826 is situated external to the enclosure 821.
[0102] Now turning to the next figure, FIG. 8C illustrates pressure
sensing module 820 in accordance with yet another exemplary
embodiment of the present invention. In embodiments such as the one
depicted in this figure, a pressure sensing module 820 for
monitoring and measuring a change in intrauterine pressure during
labor, without rupturing the amniotic sac, may include a second
chamber 823 configured to house the sensing circuitry 826, which is
coupled to the pressure-sensing membrane 824 without any interface
fluid in-between. In some exemplary embodiments, sensing circuitry
826 may employ transmitters or transceivers and the like to
communicate with a remote monitor or monitoring device 828.
[0103] In some exemplary embodiments, sensing circuitry 826 may
comprise one or more sensors adapted to generate sensing signals
concerning a pressure applied to the pressure-sensing membrane 824.
The sensors may include optical sensors, strain gauges, capacitive
sensors, Hall Effect sensors, and the like, and may measure stress
and/or strain and/or deflection of the pressure-sensing membrane
824.
[0104] Monitoring device 828 may facilitate presenting sensing data
including but not limited to changes in the intrauterine pressure
of a patient in labor, which may be monitored before rupturing the
amniotic sac. As briefly mentioned above, an advantage of
monitoring intrauterine pressure without rupturing the amniotic sac
is a decrease in the ration of intrauterine infections for the
mother and fetus during labor. Moreover, a monitoring device 828
may facilitate recording of the number of contractions and visually
appreciating contraction patters that will be useful t the operator
during the patient's labor.
[0105] Turning now to the next figure, FIG. 9 illustrates an
exemplary multi-balloon catheter system in accordance with the
present invention, shown inside a woman's reproductive system. More
specifically, FIG. 9 depicts system 900, comprising: a catheter 901
including a uterine balloon 902, as well as a vaginal balloon 903
situated below or closer to the proximate end of the catheter than
the uterine balloon and adapted to secure the uterine balloon
inside the uterus; more specifically vaginal balloon 903 secures
catheter 901 so that uterine balloon 902 may be more stable in its
position in the lower section of the uterus. Moreover, catheter 901
includes several ports. In the embodiment shown in FIG. 9, catheter
901 includes ports 904, 905, 906, and 907.
[0106] Port 904 may, for example and in no way limiting the scope
of the present invention, fluidly communicate with a conduit within
catheter 901 that may be used by an operator for inserting a stylet
that guides the catheter into cervix of the patient. Port 905 may,
for example and in no way limiting the scope of the present
invention, fluidly communicate with a conduit that fluidly connects
port 905 to port 906 via an interior of the uterine balloon 902, in
a manner such that injecting a fluid into port 906 may inflate
balloon 902 as well as reach a chamber within pressure-sensing
module 901 fluidly coupled to port 906. Port 907 may, for example
and in no way limiting the scope of the present invention, fluidly
communicate with vaginal balloon 903 so that injecting a fluid via
port 907 will inflate vaginal balloon 903.
[0107] In some exemplary embodiments, system 900 comprises: a
catheter 901 configured for manipulation by an operator, the
catheter including: a distal end adapted to be placed at least
partially inside a cervix of a patient; a uterine balloon 902
situated substantially at the distal end of the catheter 901
adapted to be placed at least partially inside a uterus of the
patient; a vaginal balloon 903 situated closer to the proximate end
of the catheter 901 than the uterine balloon 902 and adapted to
secure the uterine balloon 902 inside the uterus; a first port 905,
a second port 906, a third port 907, and a fourth port 904 situated
at the proximate end of the catheter, wherein the third port 907 is
in fluid communication with the vaginal balloon 903; and a conduit
fluidly communicating the first port 905 and the second port 906 to
an interior of the uterine balloon 902, wherein the uterine balloon
902 is inflated by introducing a fluid through the first port 905;
and a pressure sensing module coupled to the second port 906, the
pressure-sensing module including an enclosure having a chamber in
fluid communication with the uterine balloon 902 via the conduit, a
pressure-sensing membrane coupled to the chamber, and a sensing
circuitry coupled to the pressure-sensing membrane configured to
detect a pressure applied to the uterine balloon 902 of the
catheter 901.
[0108] A method in accordance with practice of the present
invention, may include a method 910 for monitoring and measuring a
change in intrauterine pressure during labor, without rupturing the
amniotic sac. With reference to FIG. 9 and FIG. 9A, by way of
example and in no way limiting the scope of the present invention,
such method 910 may include the following steps, disclosed in one
particular sequence although other sequences may be practiced
without limiting from the scope of the present invention.
[0109] In step 911, a pressure-sensing module may be coupled to a
catheter as described above.
[0110] In step 912, the catheter may be inserted into a vagina and
through a cervical canal of a female patient, wherein a distal end
of the catheter is placed inside the cervical canal, and a proximal
end of the catheter is kept outside the cervical canal, the
catheter including: a uterine balloon in fluid communication with
the proximal end and attached at or near the distal end of the
catheter, a first port situated at the proximate end of the
catheter, a second port situated at the proximate end of the
catheter, a conduit fluidly communicating the first port and the
second port to an interior of the uterine balloon, and a vaginal
balloon situated closer to the proximate end of the catheter than
the uterine balloon and adapted to secure the uterine balloon
inside the uterus.
[0111] In step 913, the uterine balloon may be positioned at a
lower segment of a uterus of the female patient. In exemplary
embodiments, subsequent to positioning the uttering balloon at the
lower segment of a uterus of the female patient, at step 913a, the
uterine balloon may be inflated from the proximal end and through
the catheter by introducing a fluid through the first port of the
catheter so that the fluid inflates the balloon and enters a first
chamber of the pressure-sensing module.
[0112] In step 914, the vaginal balloon may be positioned at an
external OS of the cervical canal of the female patient, prior to
inflating the vaginal balloon. Subsequently, at step 914a, the
vaginal balloon may be inflated to anchor the uterine balloon
inside the lower segment of the uterus so that the uterine balloon
rests against an amniotic sac of the female patient.
[0113] In step 915, once the vaginal balloon is secured and the
uterine balloon is anchored or secured in place against the
amniotic sac of the female patient--as discussed above--a pressure
output may be read from the pressure-sensing module, which detects
a change in intrauterine pressure or a change in pressure inside
the unruptured amniotic sac, without having to rupture the amniotic
sac.
[0114] In some exemplary embodiments, during or after the procedure
or after taking several readings, it may be desirable to take
additional measurements with instruments or devices that may be
introduced through the catheter. For example, and in no way
limiting the scope to the present invention, temperature
transducers or imaging transducers may be inserted through an
opening at the distal end of the catheter.
[0115] Turning now to the last figure, FIG. 10 depicts another flow
chart of a method in accordance with practice of the present
invention. More specifically, FIG. 10 depicts method 1000, for
monitoring and measuring a change in intrauterine pressure during
labor, without rupturing the amniotic sac. Although method 1000 is
exemplarily shown with a series of steps in one particular
sequence, method 1000 may include fewer or more steps in
alternative sequences without deviating from the scope of the
present invention.
[0116] In exemplary embodiments, a method for monitoring and
measuring a change in intrauterine pressure during labor, without
rupturing the amniotic sac, may include steps 1001-1005. In
exemplary embodiments, step 1001 may include coupling a pressure
sensing module to a catheter.
[0117] Step 1002 may include inserting the catheter into a vagina
and through a cervical canal of a female patient, wherein: a distal
end of the catheter is placed inside the cervical canal, and a
proximal end of the catheter is kept outside the cervical canal,
the catheter including: a balloon in fluid communication with the
proximal end and attached at or near the distal end of the
catheter, a first port situated at the proximate end of the
catheter, a second port situated at the proximate end of the
catheter, and a conduit fluidly communicating the first port and
the second port to an interior of the balloon. In some exemplary
embodiments, the catheter may include a plurality a plurality of
balloons and accordingly this step may further include: a first
balloon is placed inside the uterus, and a second balloon is placed
inside the vagina. In some exemplary embodiments, the catheter may
include a plurality a plurality of balloons and accordingly this
step may further include: a first balloon is placed inside the
uterus, a second balloon is placed inside the vagina, and a third
balloon is placed inside the cervical canal.
[0118] In exemplary embodiments, step 1003 may include inflating
the balloon from the proximal end and through the catheter by
introducing a fluid through a first port of the catheter so that
the fluid enters inflates the balloon and enters a first chamber of
the sensing module.
[0119] In exemplary embodiments, step 1004 reading a pressure
output from the pressure sensing module.
[0120] In exemplary embodiments, step 1005 optionally controlling a
pressure of the balloon by further inflating or deflating the
balloon. In some exemplary embodiments, this step may comprise
manually inflating or deflating the balloon. In some exemplary
embodiments, this step may comprise automatically inflating or
deflating the balloon, by for example implementation of a pump
device.
[0121] As mentioned above, the presented embodiments disclose an
inflatable system that may use a single uterine balloon, a uterine
balloon and a vaginal balloon, or a uterine and a vaginal and a
cervical balloon, or any combination thereof. In various
embodiments, each of the named balloons (vaginal, uterine,
cervical) may itself be a combination of several balloons. In some
embodiments the uterine balloon and/or the cervical balloon are
inflated by incompressible fluids, such as water or oil, to
transfer the intracorporeal pressures to extracorporeal pressure
sensors. While fluid is the best medium for transfer of pressure
throughout the system, air or other gases may also be used for this
purpose. In all applications, nontoxic liquids or gases are
preferable.
[0122] The balloons, which may have rough external surfaces in
order to keep them anchored in place, may be inflated by the
operator or by the patient herself. Various sensors and other
instruments may be used along with or as a part of the inflatable
system to monitor cervical dilation, fetal well-being, and the
woman's conditions. The disclosed inflatable system is not limited
in its application to the details of construction and the
arrangement of the components set forth in this specification or
illustrated in the drawings.
[0123] A system and method for child-bearing monitoring and
assistance has been described. The foregoing description of the
various exemplary embodiments of the invention has been presented
for the purposes of illustration and disclosure. It is not intended
to be exhaustive or to limit the invention to the precise form
disclosed. Many modifications and variations are possible in light
of the above teaching without departing from the spirit of the
invention.
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