U.S. patent application number 11/234357 was filed with the patent office on 2006-01-26 for devices and methods for cervix measurement.
This patent application is currently assigned to Cervilenz, Inc.. Invention is credited to Rosalyn P. Baxter-Jones, Joseph Stemler, Lindy Yow.
Application Number | 20060020230 11/234357 |
Document ID | / |
Family ID | 25371138 |
Filed Date | 2006-01-26 |
United States Patent
Application |
20060020230 |
Kind Code |
A1 |
Baxter-Jones; Rosalyn P. ;
et al. |
January 26, 2006 |
Devices and methods for cervix measurement
Abstract
The present invention provides several devices and methods for
determining dimensions of female reproductive organs. In one
embodiment, a device for determining a dimension of a female
reproductive organ includes a hollow member having a lumen, a
measurement member insertable into the lumen of the hollow member
and having a measurement scale disposed along a proximal portion,
and a flange having a body offset substantially perpendicular to
the hollow member. A device having a measurement member with a
distal end extending substantially perpendicular to a main body,
and an outer member with an open face and a space for advancement
therethrough of the measurement member, wherein the outer member
slidably engages the measurement member, is also provided.
Inventors: |
Baxter-Jones; Rosalyn P.;
(San Diego, CA) ; Stemler; Joseph; (Corona Del
Mar, CA) ; Yow; Lindy; (Costa Mesa, CA) |
Correspondence
Address: |
O'MELVENY & MYERS LLP
610 NEWPORT CENTER DRIVE
17TH FLOOR
NEWPORT BEACH
CA
92660
US
|
Assignee: |
Cervilenz, Inc.
|
Family ID: |
25371138 |
Appl. No.: |
11/234357 |
Filed: |
September 23, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10924411 |
Aug 23, 2004 |
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11234357 |
Sep 23, 2005 |
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10366024 |
Feb 12, 2003 |
6802817 |
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10924411 |
Aug 23, 2004 |
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09877986 |
Jun 8, 2001 |
6524259 |
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10366024 |
Feb 12, 2003 |
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Current U.S.
Class: |
600/591 ;
600/587 |
Current CPC
Class: |
A61B 5/1076 20130101;
A61B 5/435 20130101 |
Class at
Publication: |
600/591 ;
600/587 |
International
Class: |
A61B 5/103 20060101
A61B005/103 |
Claims
1. A device for determining a dimension of an organ comprising: a
measurement member having a main body, a distal end having a
portion extending substantially perpendicular to the main body, and
a measurement scale along the member, and an outer member having a
space for advancement therethrough of the measurement member,
wherein the outer member slidably engages the measurement
member.
2. The device of claim 1, wherein the outer member comprises a
plurality of extensions configured to secure the measurement member
within the space of the outer member.
3. The device of claim 1, wherein the space of the outer member
interlocks with the measurement member to slidably engage the
measurement member.
4. The device of claim 1, wherein the portion of the distal end of
the measurement member extending substantially perpendicular to the
main body comprises a shape chosen from the group consisting of a
tear-drop shape and a circular shape.
5. The device of claim 1, wherein the measurement member is angular
in cross-section.
6. The device of claim 5, wherein the space of the outer member is
angular in cross-section and configured to slidably engage the
measurement member.
7. The device of claim 1, wherein the outer member is rectangular
in cross-section.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of application Ser. No. 10/924,411,
filed Aug. 23, 2004, now allowed, which is a continuation of
application Ser. No. 10/366,024 entitled "Devices and Methods for
Cervix Measurement," filed on Feb. 12, 2003, issued as U.S. Pat.
No. 6,802,817, which is a continuation of application Ser. No.
09/877,986 entitled "Devices and Methods for Cervix Measurement,"
filed on Jun. 8, 2001, issued as U.S. Pat. No. 6,524,259, the
disclosures of which are expressly incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to medical devices and methods
of using such devices. More particularly, the invention relates to
instruments and methods to measure the length of the cervix in the
fornix vaginae and the dilation of the cervix uteri.
BACKGROUND
[0003] Preterm labor, or labor before 37 weeks gestation, has been
reported in 7 to 10 percent of all births but accounts for more
than 85 percent of all perinatal complications and death. Rush et
al., BMJ 2:965-8 (1976) and Villar et al., Res. Clin. Forums
16:9-33 (1994), which are both incorporated herein by reference. An
inverse relationship between cervical length in the fornix vaginae
and the risk of preterm labor has also been observed. Anderson et
al., Am. J. Obstet. Gynecol. 163:859 (1990); Iams et al., N. Eng.
J. Med. 334:567-72 (1996) and Heath et al., and Ultrasound Obstet.
Gynecol. 12:312-7 (1998), which all are incorporated herein by
reference. Accordingly, many physicians find it useful to examine
the cervix in the fornix vaginae as part of normal prenatal care in
order to assess risk of preterm labor.
[0004] It has long been known that the cervix normally undergoes a
series of physical and biochemical changes during the course of
pregnancy, which enhance the ease and safety of the birthing
process for the mother and baby. For example, in the early stages
of labor the tissues of the cervical canal soften and become more
pliable, the cervix shortens (effaces), and the circumference of
the proximal end of the cervical canal begins to increase at the
internal os. As labor progresses, growth of the cervical diameter
propagates to the distal end of the cervical canal, toward the
external os. In the-final stages of labor, the external os dilates
allowing for the unobstructed passage of the fetus.
[0005] In addition to the physical and biochemical changes
associated with normal labor, genetic or environmental factors,
such as medical illness or infection, stress, malnutrition, chronic
deprivation and certain chemicals or drugs can cause changes in the
cervix. For example, it is well known that the in utero exposure of
some women to diethylstilbestrol (DES) results in cervical
abnormalities and in some cases gross anatomical changes, which
leads to an incompetent cervix where the cervix matures, softens
and painlessly dilates without apparent uterine contractions. An
incompetent cervix can also occur where there is a history of
cervical injury, as in a previous traumatic delivery, or as a
result of induced abortion of the cervix is forcibly dilated to
large diameters. Details of the incompetent cervix are discussed in
Sonek, et al., Preterm Birth, Causes, Prevention and Management,
Second Edition, McGraw-Hill, Inc., (1993), Chapter 5, which is
incorporated by reference herein.
[0006] Cervical incompetence is a well-recognized clinical problem.
Several investigators have reported evidence of increased cervical
os diameter as being consistent with cervical incompetence (see
Brook et al., J. Obstet. Gynecol. 88:640 (1981); Michaels et al.,
Am. J. Obstet. Gynecol. 154:537 (1986); Sarti et al., Radiology
130:417 (1979); and Vaalamo et al., Acta Obstet. Gynecol. Scan
62:19 (1983), all of which are incorporated by reference herein).
Internal os diameters ranging between 15 mm to 23 mm have been
observed in connection with an incompetent cervix. Accordingly, a
critical assessment in the diagnosis of an incompetent cervix
involves measurement of the internal cervical os diameter.
[0007] There are also devices and methods to measure the diameter
of the external cervical os. For example, cervical diameter can be
manually estimated by a practitioner's use of his or her digits.
Although an individual practitioner can achieve acceptable
repeatability using this method, there is significant variation
between practitioners due to the subjective nature of the
procedure. To address these concerns, various monitoring and
measuring devices and methods have been developed. For example, an
instrument for measuring dilation of the cervix uteri is described
in U.S. Pat. No. 5,658,295. However, this device is somewhat large,
leading to a risk of injury to the fundus of the vagina or cervical
os. Additionally, it is not disposable and requires repeated
sterilization. Another device for measuring cervical diameter is
described, for example, in U.S. Pat. No. 6,039,701. In one version,
the device described therein has a loop element that is secured to
the cervix. The loop expands or contracts with the cervix and a
gauge is coupled to the loop for measuring changes in the loop
dimension. Such changes can then be detected by electronic means.
Accordingly, this device is rather complex and expensive to
manufacture.
[0008] Even if a woman is found to have an apparently normal
internal cervical os diameter, there may nonetheless be a risk for
preterm labor and delivery. Currently, risk assessment for preterm
delivery remains difficult, particularly among women with no
history of preterm birth. However, the findings that preterm
delivery is more common among women with premature cervical
shortening or effacement suggest that measuring the length of the
cervix would be predictive for preterm labor.
[0009] Currently, a physician has at least two options to measure
the length of the cervix in the fornix vaginae. One such method
involves serial digital examination of the cervix by estimating the
length from the external cervical os to the cervical-uterine
junction, as palpated through the vaginal fornix. Although this is
useful for general qualitative analysis, it does not afford an easy
nor accurate measurement of the length of the cervix from the
external cervical os to the cervical-uterine junction (also
described herein as the length of the cervix extending into the
vagina) and, therefore, does not provide an accurate assessment of
the risk of preterm labor. Despite the use of gloves, vaginal exams
always carry with them the risk of transmitting infectious agents,
especially to the fetal membranes, the lining and/or muscle of the
uterus, or the fetus itself.
[0010] Another method involves real-time sonographic evaluation of
the cervix. This method provides relatively quick and accurate
cervical dimensions. However, it requires expensive equipment,
highly skilled operators, as well as skill in interpretation of
results, which are all subject to human error. Also, due to the
expense of the procedure many women, especially those without
proper health insurance, cannot afford to have a sonographic test
performed.
[0011] It would be beneficial if there were an instrument a
practitioner could use to measure the cervix quickly and
accurately, and with little material expense. Although there are
several instruments available for determining various dimensions of
the uterus, there is no suitable instrument for measuring the
length of the cervix in the fornix vaginae. For example, U.S. Pat.
No. 4,016,867 describes a uterine caliper and depth gauge for
taking a variety of uterine measurements, which although useful for
fitting an intrauterine contraceptive device, is not capable of
measuring the length of the cervix in the fornix vaginae due to
interference by the caliper's wings. In fact, similar devices
described in U.S. Pat. Nos.: 4,224,951; 4,489,732; 4,685,747; and
5,658,295 suffer from similar problems due to their use of
expandable wings or divergable probe tips. These devices are also
relatively sophisticated, making them expensive to manufacture and
purchase. U.S. Pat. No. 3,630,190 describes a flexible intrauterine
probe, which is particularly adapted to measuring the distance
between the cervical os and the fundus of the uterus. The stem
portion of the device has a plurality of annular ridges spaced
apart from each other by a predetermined distance, preferably not
more than one-half inch apart. However, this device is not adapted
for accurately measuring the length of the cervix in the fornix
vaginae because of the lack of an appropriate measuring scale and a
stop for automatically recording the measurement.
[0012] Accordingly, there is currently no commercially available,
quick, and inexpensive as well as accurate device to assess the
risk of preterm labor by measuring the length of the cervix in the
fornix vaginae. Therefore, many women at risk for preterm labor may
be unaware of the risk to their pregnancy and their unborn child.
If such a device were available, many more women would be better
informed about the course of their pregnancy and would then be able
to make better choices about becoming pregnant at all, or about
managing their pregnancy to reduce the risk of preterm labor and
injury to the unborn child.
[0013] Thus, there exists a need for a simple and inexpensive
device that can be used to determine the length of the cervix in
the fornix vaginae and, thus, predict the risk of preterm labor, as
well as other conditions. There is also a need for such a device
that can measure the dilation of the cervix uteri, to provide an
overall assessment of the cervix and to determine the particular
stage of labor. Ideally, the device should be adapted for use by a
physician or obstetrician or even a trained nurse in the doctor's
office or clinic. Preferably, the device should be disposable or
capable of being sterilized. In addition, it is desirable that
device record the measurement automatically. The present invention
satisfies these needs and provides related advantages as well.
SUMMARY OF THE INVENTION
[0014] The present invention provides devices and methods for
determining a dimension of a female reproductive organ.
[0015] In one aspect of the present invention, a device for
determining a dimension of an organ may include a hollow member
with a distal end, a proximal end, and a lumen therebetween, and a
measurement member with a distal portion, a proximal portion, and a
measurement scale disposed along the proximal portion, wherein the
measurement member may be inserted into the lumen of the hollow
member. The measurement scale of the measurement member may have a
plurality of color-coded incremental markings. Additionally, the
device may include a flange having a body offset substantially
perpendicular to the hollow member, wherein the flange is attached
to the distal end of the hollow member. A light element configured
to emit light toward the distal end of the measurement member may
also be provided on the device.
[0016] The light element of the device may comprise a light
emitting component and an attachment means coupled to the light
emitting component, wherein the attachment means is configured to
secure the light element to the hollow member. In one embodiment,
the attachment means comprises screws. In another embodiment, the
attachment means comprises snap-on clips. When equipped with a
light element, the device may also include a power source and a
plurality of lead wires electrically coupling the light emitting
component of the light element to the power source. In embodiments
where the light element is disposed within the distal portion of
the measurement member, the device may comprise a handle having an
interior space, wherein the handle is attached to the proximal
portion of the measurement member, a power source disposed within
the interior space of the handle, and a plurality of lead wires
attached to the power source and extending through the measurement
member. In this embodiment, the lead wires electrically couple the
light element with the power source.
[0017] The flange of the device may include a plurality of
measurement markings on the body, and an opening suitable for
advancement therethrough of the measurement member. The flange may
be constructed of a substantially translucent material.
[0018] In another aspect of the present invention, a device for
determining a dimension of an organ is provided that includes a
hollow member having a distal end, a proximal end, and a lumen
therebetween, and a measurement member having a distal portion, a
proximal portion, and a measurement scale disposed along the
proximal portion. The measurement member may be inserted into the
lumen of the hollow member. The device may include a flange having
a body offset substantially perpendicular from the hollow member
and an opening for advancement of the measurement member
therethrough. The flange may be attached to the distal end of the
hollow member.
[0019] The device may also incorporate a light element disposed
within the measurement member. In one embodiment, at least the
distal portion of the measurement member is substantially
translucent. The device may include a handle attached to the
proximal portion of the measurement member and housing a power
source, wherein the power source is coupled to the light element.
Additionally, an outer sleeve may surround the handle. The outer
sleeve may comprise an outer shell with an interior space having a
proximal region and a distal region, and a resilient element within
the proximal region of the interior space of the outer shell,
wherein the handle is disposed in the distal region of the interior
space of the outer shell.
[0020] In another aspect of the present invention, a device for
determining a dimension of an organ is provided that may include a
measurement member having a main body, a distal end extending
substantially perpendicular to the main body, and a measurement
scale along the member, and an outer member having a distal end, a
proximal end, an open face, and a space for advancement
therethrough of the measurement member. The outer member slidably
engages the measurement member. The outer member may include a
plurality of extensions parallel to the open face. Here, the
extensions secure the measurement member within the space of the
outer member. In another embodiment, the space of the outer member
interlocks with the measurement member to slidably engage the
measurement member.
[0021] The distal end of the measurement member may be a tear-drop
shape. In another embodiment, the distal end of the measurement
member may be a circular shape. The measurement member may be
angular in cross-section. When the measurement member is angular in
cross-section, the space of the outer member may be angular in
cross-section and configured to slidably engage the measurement
member. Alternatively, the outer member may be rectangular in
cross-section.
[0022] Other objects and features of the present invention will
become apparent from consideration of the following description
taken in conjunction with the accompanying drawings.
DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 illustrates a device of the present invention having
a measurement member, a hollow member, a flange, a locking
mechanism, and a pin on the measurement member that travels within
a slot on the hollow member.
[0024] FIG. 2 illustrates a flange suitable for incorporation with
the devices of the present invention.
[0025] FIG. 3 illustrates a device as shown in FIG. 1 and further
including a detachable light emitting component attached to the
circumference of the hollow member.
[0026] FIG. 4 illustrates a device of the present invention that
includes a light emitting component integrated into the measurement
member and located in the distal portion of the measurement member,
and a handle that includes a power source for the light
component.
[0027] FIG. 5 illustrates a device of the present invention having
another embodiment of a locking mechanism.
[0028] FIG. 6a(i) is a cross-sectional view of a device of the
present invention that includes a hollow member and a measurement
member having shapes configured for fixing the position of the
measurement member without the need for an additional locking
mechanism.
[0029] FIG. 6a(ii) is a cross-sectional view of the device shown in
FIG. 6a(i) showing a locked position of the hollow member and the
measurement member.
[0030] FIG. 6b is a cross-sectional view of a device of the present
invention incorporating a self-locking feature that includes a slot
on the hollow member and a protrusion on the measurement member
designed to engage a side wall of the slot in order to fix the
position of the measurement member.
[0031] FIG. 6c is a cross-sectional view of a device of the present
invention incorporating a self-locking feature that includes an
opening on the hollow member, a fastening member inserted into the
opening, and a flat face on the measurement member, wherein the
fastening member is inserted into the opening and engages the flat
face to fix the position of the measurement member.
[0032] FIG. 6d is a cross-sectional view of a device of the present
invention incorporating a self-locking feature that includes a
protrusion on the inner wall of the hollow member and a flat face
on the measurement member, wherein the protrusion engages the flat
face to fix the position of the measurement member.
[0033] FIG. 6e is a cross-sectional view of a device of the present
invention incorporating a self-locking feature that includes an
opening on the hollow member, a fastening member, such as, e.g., a
screw, inserted into the opening, and an indentation extending
longitudinally on the measurement member, wherein the fastening
member is inserted into the opening and engages the indentation to
fix the position of the measurement member.
[0034] FIG. 6f is a cross-sectional view of a device of the present
invention incorporating a self-locking feature that includes a
protrusion on the inner wall of the hollow member and an
indentation extending longitudinally on the measurement member,
wherein the protrusion engages the indentation to fix the position
of the measurement member.
[0035] FIG. 6g(i)is a cross-sectional view of a device of the
present invention incorporating a self-locking feature that
includes an opening on the hollow member, a fastening member
inserted into the opening, and two flat faces on the measurement
member.
[0036] FIG. 6g(ii)is a cross-sectional view of the device shown in
FIG. 6g(ii) along the line 6g(i).
[0037] FIG. 7 is a device of the present invention that includes a
pressure controlling sleeve surrounding the handle of the
device.
[0038] FIG. 8 is a top plan view of another device of the present
invention.
[0039] FIG. 8A is a cross-sectional view of the device shown in
FIG. 8 along the line 8A-8A.
[0040] FIG. 8B is a cross-sectional view of the device shown in
FIG. 8 along the line 8B-8B.
[0041] FIG. 8C is a side view of the device shown in FIG. 8.
[0042] FIG. 8D is a side view of a measurement member of the device
shown in FIG. 8.
[0043] FIG. 9 is a top plan view of another embodiment of a device
of the present invention.
[0044] FIG. 9A is a cross-sectional view of the device of FIG. 9
along the line 9A-9A.
[0045] FIG. 9B is a cross-sectional view of the device shown in
FIG. 9 along the line 9B-9B.
[0046] FIG. 9C is a side view of the device shown in FIG. 9.
[0047] FIG. 9D is a side view of a measurement member of the device
shown in FIG. 9.
DETAILED DESCRIPTION
[0048] The present invention provides various devices and methods
for determining dimensions of female reproductive organs. For
example, the device is particularly adapted for determining the
length of the cervix in the fornix vaginae, which, as described
above, is related to the risk of preterm labor in an individual.
The device is also suited for determining the dilation of the
cervix uteri, for predicting the risk of preterm labor or the
particular stage of delivery. It is, however, contemplated herein,
and also understood by those skilled in the art, that the invention
can be used not only for determining various dimensions of female
reproductive organs. For example, the invention is usable for
determining the dimension of any body cavity or passageway where
such a device would be insertable, such as a vagina, uterus, mouth,
throat, nasal cavity, ear channel, rectum, and also to any cavity
created and opened by surgery, for example, during chest, abdominal
or brain surgery. The device is also preferably fabricated from
relatively inexpensive materials and the measurement is quick to
perform. Thus it allows the practitioner to repeat the test over
time and therefore to more closely monitor a woman's pregnancy and
risk for preterm labor. It is also contemplated that the device
records the various measurements automatically, where the only
input required by the practitioner is the proper insertion of the
device into the body cavity or passageway. This is accomplished by
the use of the flange to stop progression of the hollow member of
the device while still allowing the measurement member to be
advanced within the body.
[0049] As used herein the term "distal" refers to the end or
portion of a device of the present invention, or a component
thereof, that is adapted to be inserted first into a body cavity or
passageway. As such, it will be that part of a device of the
present invention furthest from the user while the device is
inserted and progressed within the body cavity. Conversely, as used
herein, the term "proximal" refers to the end or portion of the
device nearest the user while the device is being inserted and
progressed within the body cavity.
[0050] Turning to FIG. 1, a measuring device 100 of the present
invention is illustrated. Measuring device 100 includes an
elongated hollow member 104 having a distal region with a distal
end, a proximal region with a proximal end, and a lumen extending
between the distal and proximal ends. An elongated measurement
member 102 is provided and is designed to be inserted into the
hollow member 104, and specifically into the lumen of the hollow
member 104. The measurement member 102 is elongate in shape and has
a proximal region with a proximal end and a distal region with a
distal end. The measurement member 102 is capable of being
progressed coaxially within hollow member 104 both proximally and
distally. In the illustrated embodiment of measuring device 100,
attached to the proximal end of the measurement member 102 is a
handle 112. In one embodiment, the handle 112 is molded from the
same material as the measurement member 102. Suitable materials and
methods for the manufacture of the devices of the present invention
are discussed herein. Alternatively, the handle 112 is a rubber or
foam component that is fitted on to and over the proximal end of
the measurement member 102.
[0051] A measurement scale 118 is disposed along the proximal
portion of the measurement member 102. As used herein, the
"measurement scale" refers to any number of a series of visual
markings on the measurement member 102 at or near the proximal end,
which relate a measurement or distance. In a particularly preferred
embodiment, the measuring scale 118 includes a plurality of
millimeter (mm) incremental markings and a plurality of centimeter
(cm) incremental markings. As illustrated in FIG. 1, the
measurement scale 118 includes relatively larger markings at 1, 2,
3, 4, and 5 cm in addition to a plurality of millimeter incremental
markings between the centimeter markings. Further, a critical mark
120 is preferably present at approximately 2.5 cm. In one
embodiment, the critical mark 120 is presented in a different
color, such as, e.g., a red color, relative to the other
incremental markings of the measurement scale 118. The critical
mark 120 is used to quickly notify a user of device 100 that a
particular cervix length represents a greater risk of preterm
delivery relative to longer cervix lengths. In another embodiment
of the device 100, the measurement scale 118 is coded into a
plurality of regions. For example, in one implementation of this
embodiment, the incremental markings less than 2 cm are coded in a
first color, such as, e.g., red, the incremental markings from 2 to
3 cm are coded in a second color, such as, e.g., yellow, and the
incremental markings from 3 to 5 cm are coded in a third color,
such as, e.g., green. In this embodiment, the measurement scale 118
is color-coded into three regions that each visually represents the
relative risks of preterm delivery for a cervix length falling
within the respective region. In the above described example, for
instance, the red zone indicates a shorter cervix, and therefore a
higher risk of preterm delivery, than the yellow zone, which
indicates a cervix length that reflects a higher risk of preterm
delivery than the green zone. The measurement scale 118 is capable
of being coded into regions based upon other distinguishing marks
also, such as, e.g., a first region having a first type of marking
for the measurement increments, a second region having a second
type of marking for the measurement increments, and a third region
having a third type of marking for the measurement increments. In
other embodiments of device 100, the incremental markings are in
English measurements, such as inches and increments thereof, rather
than the metric increments previously discussed.
[0052] As illustrated, the device 100 preferably includes a slot
114 oriented along the length-wise axis of hollow member 104.
Additionally, measurement member 102 includes a pin 116 disposed
distally from the measurement scale 118. In operation, measurement
member 102 is placed within hollow member 104 such that pin 116
protrudes through slot 114. As a result, measurement member 102 is
slidable within hollow member 104 while the rotation of measurement
member 102 within hollow member 104 is significantly reduced.
[0053] In another embodiment of device 100 designed to reduce the
amount of rotation of measurement member 102 while progressed
within hollow member 104, the measurement member 102 and hollow
member 104 are not circular in shape. For example, both the
measurement member 102 and hollow member 104 may be rectangular
octagonal, square, or another shape having at least one angle such
that any rotation of the measurement member 102 within hollow
member 104 is substantially reduced and prevented by the angles of
the measurement member 102 and hollow member 104. A non-circular
measurement member 102 and hollow member 104 may additionally
include slot 114 on the hollow member 104 and pin 116 on the
measurement member 102 to further decrease the amount of rotation
between the two members.
[0054] Attached to the distal end of hollow member 104 is a flange
106 that is shaped for non-abrasive contact with tissue. As seen in
FIG. 1 and FIG. 2, which is an illustration of device 100 along the
line 2-2, the flange 106 is preferably flat and spherically or
conically shaped. Alternatively, however, the flange 106 may be any
other non-abrasive shape to reduce irritation and scraping of the
cervical canal, fundus of the vagina or perforation of the fundus
of the uterus. The main body of flange 106 is also preferably
offset from the longitudinal axis of device 100. Additionally,
flange 106 includes an opening 105 through which measurement member
102 may be advanced distally after the flange 106 contacts a bodily
surface. When the device 100 is used to measure the length of a
cervix, the device 100 is advanced into the vagina until flange 106
is placed into contact with the end of the cervix at the external
uterine opening. At this point, further forward progress of the
hollow member 104 within the cervical canal or further within the
body is prevented as a result of the contact between flange 106 and
the end of the cervix at the external uterine opening. Since flange
106 is preferably offset from the longitudinal axis of device 100,
in one manner of operation optimal for measuring the length of the
cervix, flange 106 is placed both in contact with the end of the
cervix and also covering the external uterine opening. As a result,
device 100 is oriented so that measurement member 102 is still able
to be progressed within the fornix, rather than being advanced
through the uterus, since the body of flange 106 is, with this
method, covering the external uterine-opening. Subsequently,
measurement member 102 is continued to be advanced through opening
105 of flange 106 until the distal end of the measurement member
102 contacts a wall of the body, such as, e.g., the anterior
fornix. The length of the cervix is then measured by observing the
position of the proximal end of the hollow member 104 along the
measurement scale 118 of the measurement member 102.
[0055] In another embodiment of the device 100, the flange 106
further includes a plurality of measurement marks 122 that are, for
example, usable for measuring the dilation of the cervix or
external uterine opening. Here, the flange 106 is preferably
manufactured from a substantially transparent or translucent
material, such as plastic, so that the user is able to observe the
flange 106 while the flange 106 is placed within the body. After
the flange 106 contacts the external uterine opening, the user is
able to measure the dilation of the cervix by comparing the size of
the external uterine opening with the measurement marks 122 on the
flange 106. The measurement marks 122 may be metric, such as, e.g.,
incremental marks of millimeters, centimeters, or a combination
thereof, or in English scale, such as, e.g., inches.
[0056] Preferably, the flange 106 is secured to the distal end of
the hollow member 104 using a suitable attachment means, such as,
e.g., an adhesive. Alternatively, the flange 106 may be formed as
an integral component of the hollow member 104.
[0057] Referring back to FIG. 1, a locking mechanism 124 is
preferably located on the device 100 that allows a user to secure
the measurement member 102 within the hollow member 104 after a
measurement of a body part, such as, e.g., the length of the
cervix, has been taken. The locking mechanism 124 preferably
includes a collar 108 disposed around the circumference of the
hollow member 104 and a locking knob 110 insertable into the collar
108. In one embodiment, as shown in FIG. 1, the locking knob 110
resembles a fastening member, such as, e.g., a screw, with an
enlarged area to facilitate the handling of the locking knob 110.
Preferably, the locking knob 110 is ergonomically designed so that
it may also be used as a handle during the operation and
positioning of the device 100 within the body. The collar 108
preferably includes an opening through which the locking knob 110
is capable of being inserted. Additionally, in this embodiment, the
hollow member 104 also includes an opening through which the
locking knob 110 is inserted after the locking knob 110 is inserted
into the collar 108. For example, after a measurement of a body
part is taken with the device 100, a user may lock the position of
the measurement member 102 within the hollow member 104, and
therefore the position of the proximal end of the hollow member 104
along the measurement scale 118 of the measurement member 102, by
ensuring that the openings of the collar 108 and the hollow member
104 are aligned and then inserting the locking knob 110 through
both openings simultaneously. The locking knob 110 is then threaded
through the collar 108 and the hollow member 104 until the locking
knob 110 engages the measurement member 102. Once the locking knob
110 engages the measurement member 102, the locking knob 110 is
tightened so that movement of the measurement member 102 proximally
or distally within the hollow member 104 is prevented. In another
embodiment, rather than having an opening on the hollow member 104
for the locking knob 110, the hollow member 104 includes a
deformable region around the circumference of the hollow member 104
at the approximate region where the locking mechanism 124 is
placed. Here, continued tightening of the locking knob 110
compresses the deformable region of the hollow member 104, thereby
placing pressure against the measurement member 102 at the
approximate point of the deformable region. Once the deformable
region of the hollow member 104 is sufficiently compressed by the
locking knob 110, the measurement member 102 is fixed in place
within the hollow member 104. In one embodiment, the deformable
region is formed by forming a plurality of slits along the
circumference of the hollow member 104 at the approximate location
of the deformable region.
[0058] Turning to FIG. 3, a device 100 of the present invention is
shown that includes a light component 126 secured to the hollow
member 104. The light component 126 is capable of being oriented to
direct light toward the distal end of the hollow member 104. In
operation, the light component 126 provides illumination within the
body in order to facilitate the placement of the device 100 within
the body. Also, in embodiments of the device 100 where the flange
106 includes a plurality of measurement marks 122, the light
component 126 is capable of being oriented to also direct light
toward the flange 106, thereby increasing the visibility of the
measurement marks 122 on the flange 106 when the device 100 is
within the body. As illustrated, the light component 126 includes
attachment means 128 used to secure the light component 126 to the
hollow member 104. In one embodiment, the attachment means 128 are
removable from the hollow member 104. The attachment means 128 may
be, for example screws designed for secure insertion into
corresponding openings on the hollow member 104, or snap-on clips.
When the light component 126 uses snap-on clips as the attachment
means 128, the light component 126 may be positioned at various
locations along the length of the hollow member 104 and at various
positions around the circumference of the hollow member 104. In
another embodiment, the light component 126 is an integral part of
the hollow member 104. Here, the light component 126 is permanently
affixed to the hollow member 104 in a predetermined orientation,
such as, e.g., an orientation that directs light substantially
toward the distal end of the hollow member 104 and to flange 106,
and is not removable from the hollow member 104.
[0059] In one embodiment of light component 126, light component
126 is powered using a battery that is disposed within the interior
of light component 126. In another embodiment, an external power
source is provided in lieu of a battery integrated into the
interior of the light component 126. When an external power source
is used, lead wires are provided that electrically couple the light
component to the external power source. The lead wires preferably
include a positive wire, a negative wire, and a ground wire.
Alternatively, the lead wires include a positive wire and a
negative wire, with one of the wires being grounded at some
location outside the body, such as, e.g., near the external power
source.
[0060] FIG. 4 is a device 200 of the present invention that
incorporates a light element 230 as part of the measurement member
202. The device 200 includes a hollow member 204 and a measurement
member 202 configured to slide coaxially within the hollow member
204. Measurement member 202 includes a measurement scale 218 on its
proximal portion that is substantially the same as measurement
scale 118 of device 100. Similarly, device 200 includes a locking
mechanism 224 that is substantially the same as locking mechanism
124 of device 100. For example, as with locking mechanism 124,
locking mechanism 224 preferably includes a collar 208 disposed
around the circumference of the hollow member 204 and a locking
knob 210 insertable into the collar 208. Further, flange 206 of
device 200 is substantially the same as flange 106 of device 100
and is located at the distal end of hollow member 204.
[0061] Measurement member 202 of device 200 includes a lumen 216.
Additionally, device 200 includes a light element 230 disposed
within lumen 216. As illustrated, the light element 230 is located
in the lumen 216 in the distal portion of the measurement member
202. In a preferred embodiment, the light element 230 is located at
the distal end of the measurement member 202. Light element 230 is
a light-emitting component capable of generating light that is
directed substantially in a distal direction when the device 200 is
placed within the body. Light element 230 may be any suitable light
source, such as, e.g., a light-emitting diode, a laser, an
incandescent light bulb, a fluorescent substance, or the like. In
another embodiment, the light element 230 is an array of individual
light-emitting components rather than a single light-emitting
component. When an array of individual light emitting components
are used instead of a single light emitting component, the light
element 230 is capable of continually emitting light in the event
one of the array of light emitting components fails during the
operation of device 200.
[0062] To allow for light to pass there through, measurement member
202 is preferably manufactured of a substantially transparent or
translucent material such as plastic. In one embodiment, the entire
measurement member 202 is constructed from a substantially
transparent or translucent material. In another embodiment, the
distal portion of the measurement member 202 is constructed from a
substantially transparent or translucent material while the
remaining portion of the member 202 is constructed from a
substantially opaque material such as a metallic substance.
[0063] A set of leads 232a and 232b electrically couple the light
element 230 to a power source 214. In a preferred embodiment, one
of the leads is a positive electrical wire while the other lead is
a negative electrical wire. In one embodiment, the leads 232a, 232b
are disposed within the lumen 230 of the measurement member 202.
The power source 214 is a component that is capable of providing
power to the light element 230, such as, e.g., a battery or the
like. As illustrated in FIG. 4, the power source 214 is preferably
located at the proximal end of the measurement member 202 and,
specifically, housed within a handle 212. The handle. 212 is
preferably positioned at the proximal end of measurement member
202. The handle 212 has an internal space 222 designed to house the
power source 214. The internal space 222 is preferably water tight
to prevent damage to the power source 214, a switch 216, or other
components that may be disposed therein.
[0064] The handle 212 also includes a switch 216 electrically
coupled to the power source 214 that enables a user to control the
power supplied to the light element 230, as desired. In one
embodiment, the switch 216 enables a user to either turn on or turn
off the supply of power to the light element 230. Alternatively,
the switch enables a user to vary the amount of power supplied to
the light element 230, thereby allowing a user to variably dim the
light element 230 rather than merely turning it on or off. In the
illustrated embodiment, the switch 216 is a toggle or flip switch
that may be alternated between a first position and a second
position. The first and second positions generally correspond to on
and off positions respectively. In another embodiment, the switch
216 is positioned at the proximal end of the handle 212, and is
operated by turning the switch 216 in a circular fashion.
Alternatively, the switch 216 is a membrane component positioned at
the proximal end of the handle 212, and is operated by depressing
the membrane.
[0065] In an alternative embodiment of device 200, measurement
member 202 does not include a lumen 216 but, rather, is a solid
member formed of a transparent or translucent material such as
plastic. In this embodiment, the material that is used to form
measurement member 202 encases both light element 230 and leads
232a, 232b. This is in comparison to the embodiment of device 200
illustrated in FIG. 4 wherein light element 230 and leads 232a and
232b are positioned within a lumen 216. When the device 200
includes a solid measurement member 202 encasing light element 230
and leads 232a, 232b, movement of either light element 230 or leads
232a, 232b within the member 202 is substantially restricted. This
embodiment of measurement member 202 may be manufactured by
coextruding, from a plastic material, both measurement member 202
and leads 232a, 232b, thereby manufacturing a member 202 with
built-in leads 232a, 232b. With the embodiment illustrated in FIG.
4, by comparison, leads 232a and 232b lie freely within lumen
216.
[0066] In another embodiment of device 200, hollow member 204 is
composed of a substantially transparent or translucent material.
When constructed of substantially transparent or translucent
material, hollow member 204 enables light emitted from the light
element 230 to also be emitted there through. As a result, this
embodiment of device 200 enables light element 230 to emit a
greater percentage of light to the areas surrounding device
200.
[0067] Device 200, in another embodiment, includes a plurality of
ports on the distal portion of hollow member 204, such as ports 326
shown in FIG. 5 and to be discussed herein. The ports allow an
amount of light to be emitted through the hollow member 204 even
when the hollow member 204 is not constructed of a translucent
material. For example, a hollow member 204 manufactured from a
metallic material or an opaque plastic material will still allow
some amount of light to shine there through and onto the areas
surrounding the device 200 when hollow member 204 includes a
plurality of ports on its distal portion.
[0068] Illustrated in FIG. 5 is a device 300 of the present
invention. Device 300 includes a hollow member 304 and a
measurement member 302 configured to slide coaxially within the
hollow member 304. Flange 306, located at the distal end of the
hollow member 304, is substantially the same as flange 106 of
device 100. Measurement member 302 is substantially similar to
measurement member 202 of device 300. For example, measurement
member 302 includes a measurement scale 318 along its proximal
region.
[0069] Also, measurement member 302 includes a light element 330
disposed in the distal portion of measurement member 302 and leads
332a, 332b electrically coupled to the light element 330. In a
preferred embodiment, light element 330 is located at the distal
end of measurement member 302. Also, light element 330 is a
light-emitting component capable of generating light, such as,
e.g., a light-emitting diode, a laser, an incandescent light bulb,
a fluorescent material, or the like, and may be either a single
light-emitting component or an array of light-emitting
components.
[0070] In one embodiment of measurement member 302, member 302 has
a lumen 316 in which light element 330 and leads 332a, 332b are
disposed. In another embodiment, measurement member 302 has no
lumen, but is solid and manufactured from a substantially
transparent or translucent material, such as, e.g., plastic. Here,
measurement member 302 encases light element 330 and leads 332a,
332b, reducing the degree of movement of leads 332a, 332b, as
compared to the measurement member 302 having a lumen 316 and leads
332a, 332b lying freely within lumen 316. For example, this
embodiment of measurement member 302 may be manufactured by being
coextruded from a plastic material, and having built-in leads 332a,
332b.
[0071] The leads 332a, 332b are preferably a positive electrical
wire and a negative electrical wire. Further, the leads 332a, 332b
electrically couple light element 330 to a power source 314, with
may be, e.g., a battery or the like. As with device 200, the power
source 314 of device 300 is preferably located at the proximal end
of the measurement member 302 and, specifically, housed within a
handle 312. The handle 312 is preferably positioned at the proximal
end of measurement member 302. The power source is housed within an
internal space 322 of handle 312. A switch 316 on the handle 312
and electrically coupled to power source 314 enables a user to turn
on or off the power supplied to light element 330. Alternatively,
switch 316 allows a user to vary the level of power supplied to
light element 330 rather than merely providing an on or an off
setting.
[0072] Device 300 includes a locking mechanism 324 that includes a
locking knob 310 insertable into a collar 308. The collar 308 is
disposed between fixed stops 328a and 328b. Fixed stop 328a is
located adjacent to the distal end of collar 308, whereas fixed
stop 328b is located adjacent to the proximal end of collar 308.
Fixed stops 328a and 328 b maintain collar 308 at a fixed position
along the length of hollow member 304, i.e., the fixed stops 328a
and 328b prevent the collar 308 from moving along the length of
hollow member 304. Although collar 308 is fixed in place along the
length of hollow member 304 by fixed stops 328a, 328b, the collar
308 is still rotatable around the circumference of hollow member
304. As a result of the rotating aspect of collar 308, manipulation
and operation of locking mechanism 324 is facilitated since a user
is able to rotate collar 308 to a suitable position while operating
device 300. Other than the rotating aspect of locking mechanism
324, locking mechanism 324 operates in substantially the same
manner as locking mechanism 124 of device 100. For example, in one
embodiment, hollow member 304 includes an opening that is
configured for the insertion of the locking knob 310 there through.
Further, collar 308 also includes an opening that is capable of
being aligned with that opening of the hollow member 304.
Therefore, when a user desires to lock the position of measurement
member 302 within hollow member 304, the user tightens locking knob
310, while knob 310 is inserted into collar 308 and while the
openings of collar 308 and hollow member 304 are aligned. The user
continues tightening locking knob 310 until locking knob 310
engages and contacts measurement member 302. As a result, locking
knob 310 places pressure on measurement member 302, thereby
substantially preventing proximal or distal movement of the
measurement member 302 within hollow member 304. As with locking
mechanism 124, another embodiment of locking mechanism 324 operates
by compressing a deformable region on the hollow member 304 located
substantially where collar 308 is placed on the circumference of
the hollow member 304. Here, continued tightening of locking knob
310 exerts pressure on the deformable region, thereby compressing
that region and also placing pressure on measurement member
302.
[0073] As previously mentioned, device 300 includes a light element
330 that is either disposed within a lumen 316 of measurement
member 302 or encased by measurement member 302 when member 302
does not include a lumen 316. The measurement member 302 is
constructed, in whole or in part, of a transparent or translucent
material in order to allow light emitted from the light element 330
to pass there through. In one embodiment, the entire measurement
member 302 is constructed from a substantially transparent or
translucent material. In another embodiment, the distal portion of
the measurement member 302 is constructed from a substantially
transparent or translucent material while the remaining portion of
the member 302 is constructed from a substantially opaque material
such as a metallic substance.
[0074] In the illustrated embodiment, device 300 includes a
plurality of ports 326 located on the distal portion of hollow
member 304. Ports 326 allow an amount of light to be emitted
through hollow member 304 even when hollow member 304 is
manufactured from an opaque material, such as, e.g., a metallic
substance. When hollow member 304 is manufactured from a metallic
material or an opaque plastic material, light emitting from light
element 330 will pass through both the measurement member 302, at
the transparent or translucent portions of member 302, and through
ports 326 of hollow member 304. As a result, ports 326 increase the
area surrounding device 300 that is illuminated by light element
330, particularly when hollow member 304 is composed of an opaque
material. In an alternative embodiment, the entire body of hollow
member 304 is manufactured from a transparent or translucent
material, thereby allowing light emitting from light element 330 to
pass through substantially the entire length of hollow member
304.
[0075] All of the devices of the present invention include
alternative embodiments where the position of the measurement
member within the hollow member, after determining the length of
the bodily part being measured, is capable of being fixed without
the use of locking mechanisms 124, 224, or 324. Rather than
requiring a separate locking mechanism component 124, 224, or 324,
these alternative embodiments of the devices of the present
invention include hollow members and measurement members designed
to self-lock, i.e., without requiring the separate locking
mechanisms of devices 100, 200, or 300. Several devices having
self-locking hollow members and measurement members are illustrated
in cross-section in FIGS. 6a-f. The devices in FIGS. 6a-f
incorporate hollow members and measurement members incorporating
self-locking features that, first, allow for the measurement member
to travel longitudinally within the hollow member while also
restricting the rotation of the measurement member within the
hollow member. Second, the self-locking features of these devices
allow for a user to fix the position of the measurement member
within the hollow member after a measurement of a body part has
been taken.
[0076] With the exception of the specifically discussed features,
the devices illustrated in FIGS. 6a-f are substantially similar to
devices 100, 200, and 300. For example, the devices illustrated in
FIGS. 6a-f all include an elongated measurement member insertable
into an elongated hollow member and capable of being advanced
coaxially within the hollow member. A flange is present on the
distal end of the hollow member and is operable to stop the
progression of the hollow member within a body while enabling
continued progression of the measurement member. The measurement
member includes a measuring scale located on a proximal portion of
the member, in addition to a handle attached to the proximal end of
the measurement member. Further, the devices illustrated in FIGS.
6a-f may incorporate any of the light emitting components discussed
herein. Unlike devices 100, 200, and 300, however, the devices in
FIGS. 6a-d do not include a separate locking mechanism but, rather,
include the integrated self-locking features described herein.
[0077] Referring to FIGS. 6a(i) and 6a(ii), one embodiment of a
self-locking device of the present invention, device 400(a), is
illustrated. As previously discussed, with the exception of a
separate locking mechanism, device 400(a) includes substantially
the same components as the other devices of the present invention,
such as device 200 and 300, and is operated in substantially the
same manner to obtain a measurement of a dimension of a body part.
Device 400(a) includes a hollow member 404(a) and a measurement
member 402(a). Hollow member 404(a) and measurement member 402(a)
are substantially similar to hollow member 104 and measurement
member 102, with the exception of the shapes of hollow member
404(a) and measurement member 402(a). Hollow member 404(a) and
measurement member 402(a) are oval in cross-section. Further,
measurement member 402(a) is slightly flatter in cross-section that
hollow member 404(a), i.e., has a shorter minor axis 419 than the
minor axis 421 of hollow member 404(a). As with the other
embodiments of the devices of the present invention, measurement
member 402(a) is still capable of being placed within hollow member
404(a) and manipulated coaxially within hollow member 404(a). As
seen in FIG. 6a(i), when a user desires to progress measurement
member 402(a) within hollow member 404(a), device 400(a) is
operated so that measurement member 402(a) is capable of being
progressed coaxially within hollow member 404(a). For example, to
enable to move measurement member 402(a) either distally or
proximally within hollow member 404(a), device 400(a) is operated
so that the major axis 403 of measurement member 402(a) is
substantially parallel to the major axis 405 of hollow member
404(a). When the major axes 403, 405 are substantially parallel,
measurement member 402(a) may be advanced within hollow member
404(a).
[0078] Due to the relative cross-sectional shapes of the members,
however, the ability to rotate measurement member 402(a) while
traveling within hollow member 404(a) is restricted. The
restriction of the rotation of measurement member 402(a) increases
the ability to determine the position of the proximal end of hollow
member 404(a) along the measurement scale of measurement member
402(a). Further, the position of measurement member 402(a) within
hollow member 404(a) is capable of being fixed by forcibly rotating
measurement member 402(a) while a portion of member 402(a) is still
within hollow member 404(a). For example, to fix the position of
measurement member 402(a) relative to hollow member 404(a), a user
will forcibly rotate measurement member 402(a) so that major axes
403, 405 are no longer in a parallel relationship. As a result,
measurement member 402(a) will come into contact with the internal
walls of hollow member 404(a) at at least two points along the
internal walls of hollow member 404(a). The user then proceeds to
exert sufficient force to fix the position of measurement member
402(a) within hollow member 404(a). Therefore, unlike devices 100,
200, and 300, a separate locking mechanism is not required to fix
the position of measurement member 402(a) within hollow member
404(a). Alternative embodiments of device 400(a) are capable of
utilizing different cross-section shaped measurement members 402(a)
and hollow member 404(a) but having major axes 403, 405 that, when
in substantial parallel relationship, enable measurement member
402(a) to be manipulated within hollow member 404(a) and, when
displaced from a substantial parallel relationship, result in the
fixation of measurement member 402(a) within hollow member
404(a).
[0079] Referring to FIG. 6b, another embodiment of a self-locking
device of the present invention, device 400(b), is illustrated.
Device 400(b) includes a hollow member 404(b) having a slot 413
defined by side walls 413a and a measurement member 402(b) having a
protrusion 415. With the exception of a separate locking mechanism,
device 400(b) includes substantially the same components as the
other devices of the present invention, such as device 200 and 300,
and is operated in substantially the same manner to obtain a
measurement of a dimension of a body part. As with the other
devices of the present invention, measurement member 402(b), during
operation of device 400(b), is placed within, and in coaxial
alignment with, hollow member 404(b) to allow measurement member
402(b) to be manipulated proximally and distally within hollow
member 404(b). Slot 413, in a preferred embodiment, extends length
wise, and for substantially the entire length, of hollow member
404(b). In another embodiment, slot 413 extends longitudinally
along the distal portion of hollow member 404(b) for at least a
length that is substantially equivalent to the length of the
measurement scale on the proximal portion of the measurement member
402(b). Protrusion 415 of measurement member 402(b), in one
embodiment, is a single protrusion located at one position on
measurement member 402(b). In another embodiment, protrusion 415 is
a protrusion that extends length wise along substantially the
entire length of measurement member 402(b). In the embodiment where
slot 413 extends longitudinally along the distal portion of hollow
member 404(b) for at least a length that is substantially equal to
the length of the measurement scale, protrusion 415 is preferably a
single protrusion located on the distal portion of measurement
member 402(b).
[0080] While manipulating measurement member 402(b) within hollow
member 404(b), protrusion 415 is oriented so that it lies within
slot 413. The positioning of protrusion 415 within slot 413
prevents undesired rotation of measurement member 402(b) within
hollow member 404(b) while a body part is being measured. After
measuring a bodily part using measurement member 402(b), the
position of member 402(b) within hollow member 404(b) is capable of
being fixed by rotating measurement member 402(b) in order to
forcibly engage protrusion 415 against a side wall 413a of slot
413. This is accomplished by, for example, continuing to rotate
measurement member 402(b) until protrusion 415 physically contacts
a side wall 413a and then continuing to apply rotational pressure
in that direction in order to force at least a portion of
protrusion 415 beyond slot 413, i.e., at least a portion of
protrusion 415 is forced under a side wall 413a. Consequently, the
position of measurement member 402(b) becomes fixed within hollow
member 404(b) without requiring a separate locking mechanism.
[0081] FIG. 6c illustrates another embodiment of a self-locking
device of the present invention, device 400(c). Device 400(c)
includes a hollow member 404(c) and a measurement member 402(c).
Hollow member 404(c) includes an opening 417 through which a
fastening member 407 may be inserted. As with the other fastening
members of the other devices discussed herein, fastening member 407
may be, e.g., a screw. Measurement member 402(c) includes a flat
face 409 that preferably extends the length of the member 402(c).
In another embodiment, flat face 409 extends longitudinally along
the distal portion of measurement member 402(c) for at least a
length that is substantially equivalent to the length of the
measurement scale on the proximal portion of the measurement member
402(c). With this embodiment, the opening 417 and the fastening
member 407 are disposed on the distal portion of the hollow member
404(c).
[0082] Like the other devices of the present invention, measurement
member 402(c), during operation of device 400(c), is placed within,
and in coaxial alignment with, hollow member 404(c). Measurement
member 402(c) is then manipulated proximally or distally within
hollow member 404(c) in order to determine the length of the body
part being measured by observing the location of the proximal end
of hollow member 404(c) along a measurement scale on the proximal
portion of measurement member 402(c). With the exception of a
separate locking mechanism, device 400(c) includes substantially
the same components as the other devices of the present invention,
such as device 200 and 300, as is operated in substantially the
same manner to obtain a measurement of a dimension of a body
part.
[0083] During operation, fastening member 407 is inserted into
opening 417 of hollow member 404(c). While a measurement is being
taken, the position of fastening member 407 within opening 417
restricts the ability to rotate measurement member 402(c) within
hollow member 404(c). After a measurement is taken, the position of
measurement member 402(c) within hollow member 404(c) is fixed by
further tightening fastening member 407 until it contacts the flat
face 409 of measurement member 402(c). To facilitate this process,
it may be necessary to orient measurement member 402(c) in order
for flat face 409 to align with opening 417 of hollow member
404(c). Once fastening member 407 contacts the flat face 409,
additional tightening of fastening member 407 exerts pressure upon
measurement member 402(c), thereby fixing measurement member 402(c)
at that position within hollow member 404(c). As a result, device
400(c) enables a user to fix the measurement member 402(c) at a
given position within hollow member 404(c) without requiring the
use of a separate locking mechanism, as compared to device 100,
200, and 300.
[0084] Referring now to FIG. 6d, another embodiment of a
self-locking device of the present invention is shown. Device
400(d) includes a measurement member 402(d) suitable for insertion
within a hollow member 404(d). Like measurement member 402(c) of
device 400(c), measurement member 402(d) includes a flat face 409
that preferably extends substantially the length of the member
402(d). Hollow member 404(d) includes, on its internal surface, a
ridge 411. In one embodiment, ridge 411 extends substantially the
entire length of hollow member 404(d). In another embodiment, ridge
411 is a single dimple or protuberance at one location on the
internal surface of hollow member 404(d). In another embodiment of
device 400(c), flat face 409 extends longitudinally along the
distal portion of measurement member 402(d) for at least a length
that is substantially equivalent to the length of the measurement
scale on the proximal portion of member 402(d). With this
embodiment, ridge 411 is a single protuberance disposed at one
location on the internal surface of the distal portion of hollow
member 404(d).
[0085] Device 400(c) includes substantially the same components as
devices 200 and 300, with the exception of the locking mechanisms
of those devices, i.e., device 400(c) does not require a separate
locking mechanism. Device 400(d) is also operated in substantially
the same manner of the other devices of the present invention in
order to determine a dimension of a body part.
[0086] With device 400(d), however, measurement member 402(d),
while a dimension of a body part is being determined, is preferably
oriented within hollow member 404(d) such that flat face 409 is
oriented toward ridge 411. In this manner, measurement member
402(d) is freely slidable coaxially or longitudinally within hollow
member 404(d). Additionally, the range of rotational movement of
measurement member 402(d) within hollow member 404(d) is limited by
the combination of ridge 411 and flat face 409, i.e., ridge 411
restricts the rotation of measurement member 402(d) when ridge 411
contacts an edge of flat face 409.
[0087] To fix the position of measurement member 402(d) within
hollow member 404(d), after determining the dimension of a body
part, such as the length of the cervix, the measurement member
402(d) is rotated so that one edge of flat face 409 contacts ridge
411. Sufficient additional rotational force is then applied to
measurement member 402(d) so that flat face 409, and therefore
measurement member 402(d), is maintained in a fixed position by
ridge 411. As a result, the incorporation of a ridge 411 on the
internal surface of hollow member 404(d) and a flat surface 409 on
measurement member 402(d) allows a user to fix the position of
measurement member 402(d) within hollow member 404(d), thereby
preserving the location of the proximal end of hollow member 404(d)
along a measuring scale on the proximal portion of measurement
member 402(d), i.e., a measurement of a dimension of a body part,
without the use of a separate locking mechanism.
[0088] Turning to FIG. 6e, another embodiment of a self-locking
device of the present invention is shown. Device 400(e) includes a
measurement member 402(e) suitable for insertion within a hollow
member 404(e). Measurement member 402(e) includes an indentation
420 that extends longitudinally along the length of measurement
member 402(e). Indentation 420 preferably extends substantially the
length of measurement member 402(e). Hollow member 404(e) includes
an opening 417 through which a fastening member 407 may be
inserted. Device 400(e) includes substantially the same components
as devices 200 and 300, with the exception of the locking
mechanisms of those devices, i.e., device 400(e) does not require a
separate locking mechanism. Device 400(e) is also operated in
substantially the same manner of the other devices of the present
invention in order to determine a dimension of a body part.
[0089] With device 400(e), however, measurement member 402(e),
while a dimension of a body part is being determined, is preferably
oriented within hollow member 404(e) such that fastening member
407, which is inserted into opening 417 during operation, extends
into indentation 420. As a result, measurement member 402(e) is
freely slidable coaxially or longitudinally within hollow member
404(e). Further, the range of rotational movement of measurement
member 402(e) within hollow member 404(e) is limited by the
extension of fastening member 407 within indentation 420.
[0090] To fix the position of measurement member 402(e) within
hollow member 404(e), after determining the dimension of a body
part, such as the length of the cervix, fastening member 407 is
tightened such that it engages the bottom surface of indentation
420. Subsequently, fastening member 407 is additionally tightened
to ensure that measurement member 402(e) is maintained in a fixed
position by the engagement of the bottom surface of indentation 420
by fastening member 407. As a result, the incorporation of an
indentation 420 on measurement member 402(e), in combination with a
fastening member 407 insertable into hollow member 404(e) and
capable of being engaged with indentation 420, allows a user to fix
the position of measurement member 402(e) within hollow member
404(e), thereby preserving the location of the proximal end of
hollow member 404(e) along a measuring scale on the proximal
portion of measurement member 402(e), i.e., a measurement of a
dimension of a body part, without the use of a separate locking
mechanism.
[0091] Referring now to FIG. 6f, another embodiment of a
self-locking device of the present invention is shown. Device
400(f) includes a measurement member 402(f) suitable for insertion
within a hollow member 404(f). Like measurement member 402(e) of
device 400(e), measurement member 402(f) includes an indentation
422 that preferably extends longitudinally along substantially the
length of the member 402(f). Hollow member 404(f) includes, on its
internal surface, a protrusion 424. In one embodiment, protrusion
424 extends substantially the entire length of hollow member
404(f). In another embodiment, protrusion 424 is a single dimple or
detent at one location on the internal surface of hollow member
404(f). Device 400(f) includes substantially the same components as
devices 200 and 300, with the exception of the locking mechanisms
of those devices, i.e., device 400(f) does not require a separate
locking mechanism. Device 400(f) is also operated in substantially
the same manner of the other devices of the present invention in
order to determine a dimension of a body part.
[0092] With device 400(f), however, measurement member 402(f),
while a dimension of a body part is being determined, is preferably
oriented within hollow member 404(f) such that protrusion 424 lies
within indentation 422. In this manner, measurement member 402(f)
is freely slidable coaxially or longitudinally within hollow member
404(f). Additionally, the range of rotational movement of
measurement member 402(f) within hollow member 404(f) is limited by
the positioning of protrusion 424 within indentation 422.
[0093] To fix the position of measurement member 402(f) within
hollow member 404(f), after determining the dimension of a body
part, such as the length of the cervix, the measurement member
402(f) is rotated so that one edge of indentation 422 contacts
protrusion 424. Sufficient additional rotational force is then
applied to measurement member 402(f) so that indentation 422, and
therefore measurement member 402(f), is maintained in a fixed
position by protrusion 424. As a result, the incorporation of a
protrusion 424 on the internal surface of hollow member 404(f) and
an indentation on measurement member 402(f) allows a user to fix
the position of measurement member 402(f) within hollow member
404(f), thereby preserving the location of the proximal end of
hollow member 404(f) along a measuring scale on the proximal
portion of measurement member 402(f), i.e., a measurement of a
dimension of a body part, without the use of a separate locking
mechanism.
[0094] Turning to FIGS. 6(g)(i) and 6(g)(ii), another embodiment of
a self-locking device of the present invention, device 500, is
shown. FIG. 6(g)(ii) is a cross-sectional view of device 500 along
the line 6(g)(ii). Device 500 includes a hollow member 504 and a
measurement member 502. A flange 506 is located at the distal end
of hollow member 504 and allows for measurement member 502 to slide
there through. Hollow member 504 includes an opening 517 through
which a fastening member 507 may be inserted. As with the other
fastening members of the other devices discussed herein, fastening
member 507 may be, e.g., a screw. Further, fastening member 507, in
one embodiment of device 500, is permanently fixed in position
within opening 517 and hollow member. 504. Measurement member 502
includes a first and second flat face 509a, 509b that are in
opposing relation to each other. The embodiment of device 500
illustrated in FIG. 6g(i)includes flat faces 509a, 509b that extend
longitudinally along the distal portion of measurement member 502
for at least a length that is substantially equivalent to the
length of a measurement scale 518 on the proximal portion of the
measurement member 502. Here, the opening 517 and the fastening
member 507 are disposed on the distal portion of the hollow member
504.
[0095] Like the other devices of the present invention, measurement
member 502, during operation of device 500, is placed within, and
in coaxial alignment with, hollow member 504. Measurement member
502 is then manipulated proximally or distally within hollow member
504 in order to determine the length of the body part being
measured by observing the location of the proximal end of hollow
member 504 along a measurement scale on the proximal portion of
measurement member 502. With the exception of a separate locking
mechanism, device 500 includes substantially the same components as
the other devices of the present invention, such as device 200 and
300. In the embodiment of device 500 shown in FIGS. 6(g)(i) and
6(g)(ii), the device 500 includes a handle 512 attached to the
proximal end of the measurement member 502 that houses a power
source 514 and a switch 516 that controls the application of power
from the source 514 to a light element 530. The light element 530
is preferably located within the distal portion of measurement
member 502 and is electrically coupled to the power source 514 via
lead wires 532a and 532b. Lead wires 532a and 532b also
electrically couple the power source 514 to the switch 516. When a
light element 530 is provided, the measurement member 502 and the
hollow member 504 are manufactured from a substantially translucent
material such as plastic. Alternatively, device 500 is provided
without light element 530, power source 514, switch 516, and lead
wires 532a, 532b in order to reduce manufacturing costs of the
device 500.
[0096] Device 500 is operated in substantially the same manner as,
e.g., devices 200 and 300 to obtain a measurement of a dimension of
a body part. During operation, fastening member 507 is disposed
within opening 517 of hollow member 504. Preferably, measurement
member 502 is oriented within hollow member 504 such that one of
flat faces 509a or 509b is positioned toward the fastening member
507. In one embodiment, corresponding markings are provided on the
proximal portions of both measurement member 502 and hollow member
504 that, when in alignment, indicate to the user that measurement
member 502 is oriented such that one of flat faces 509a or 509b is
positioned toward fastening member 507.
[0097] While a measurement is being taken, the position of
fastening member 507 within opening 517 restricts the ability to
rotate measurement member 502 within hollow member 504. For the
embodiment of device 500 where the fastening member 507 is fixed in
position within opening 517, after a measurement is taken, the
position of measurement member 502 within hollow member 504 is
fixed by forcibly rotating the measurement member 502 until one of
the ends 510, i.e., not flat face 509a or 509b, faces fastening
member 507. When this is achieved, measurement member 502 is held
in place within hollow member 504 by pressure exerted by fastening
member 507 on one of the ends of measurement member 502.
Alternatively, in an embodiment of device 500 where fastening
member 507 is not permanently fixed but, rather, is removable from
opening 517, to fix the position of measurement member 502 a user
may further tighten fastening member 507 until it contacts a flat
face 509a or 509b of measurement member 502. Once fastening member
507 contacts a flat face 509a or 509b, additional tightening of
fastening member 507 exerts pressure upon measurement member 502,
thereby fixing measurement member 502 at that position within
hollow member 504 ). As a result, device 500 enables a user to fix
the measurement member 502 at a given position within hollow member
504 without requiring the use of a separate locking mechanism, as
compared to devices 100, 200, and 300.
[0098] In another embodiment of the present invention, any of the
devices disclosed herein is modified by the addition of a
spring-loaded outer sleeve 700 to the handle of that device. The
spring-loaded outer sleeve 700 of the present invention, when used
in conjunction with one of the devices disclosed herein, allows a
constant pressure to be maintained on the device, and specifically
on the measurement member, while the device is being advanced
within the body. The outer sleeve 700 also prevents undue pressure
from being exerted against a bodily surface during the operation of
the device by absorbing some of the pressure used to manipulate the
device within the body. As a result, outer sleeve 700 reduces the
risk of the device puncturing a bodily wall while a measurement of
a dimension of a body part is taken with the device.
[0099] As illustrated in FIG. 7, outer sleeve 700 includes an outer
shell 704 capable of being placed over a handle of a device of the
present invention. As shown in Figure 7, outer sleeve 700, and
specifically outer shell 704, is placed over handle 212 of device
200. Outer sleeve 700 is, however, capable of being placed over any
of the other handles of the other devices disclosed herein. Outer
shell 704 includes sufficient interior space to accommodate a
handle of a device of the present invention as well as a spring
element 702, or other resilient structure. In a preferred
embodiment, spring element 702 is secured to a proximal wall of the
outer shell 704 using a suitable attachment means, such as, e.g.,
an adhesive.
[0100] Preferably, outer shell 704 is placed over, for example,
handle 212 of device 200, and handle 212 is situated distally
relative to spring element 702. A user will then advance
measurement member 202 by manipulating outer sleeve 700. As
measurement member 202 is advanced, spring element 702 absorbs any
force over a preset level, the level being dependent on the
resiliency of the spring element 702 incorporated into outer sleeve
700. Therefore, outer sleeve 700 prevents the force used to advance
measurement member 202 from exceeding a present level.
Additionally, after the distal end of measurement member 202
contacts a body wall or surface, outer sleeve 700 prevents
measurement member 202 from puncturing that surface by absorbing
additional force via spring element 702.
[0101] In one embodiment, outer sleeve 700 is manufactured from a
metallic material, such as, e.g., brass, stainless steel, or the
like. In another embodiment, outer sleeve 700 is manufactured from
a plastic material. When formed from plastic, outer sleeve 700 may
be manufactured using a plastic extrusion technique known in the
art. Preferably, the outer sleeve 700 is placed on a handle of a
device of the present invention, such as handle 212, at the time
the entire device is manufactured and assembled. In one embodiment,
the handle is placed into the outer shell 704 and distal relative
to the spring element 702. The distal end of the outer shell 704 is
then crimped in order to fix the outer sleeve 700 around the
handle. In another embodiment, the handle is placed within the
outer shell 704 and then a suitable element, such as, e.g., a
washer or the like, is affixed over the distal opening of the outer
shell 704 using a suitable adhesive or soldering technique in order
to maintain the handle within the outer sleeve 700. Alternatively,
the outer surface of the handle and the inner surface of the outer
shell 704 of the sleeve 700 may contain corresponding threads or
grooves, thereby enabling the sleeve 700 to be threaded onto the
handle. The outer sleeve 700, in another embodiment, is press fit
onto the handle.
[0102] Illustrated in FIG. 8 is another embodiment of the present
invention, device 800. FIG. 8 is a top plan view of device 800,
FIG. 8C is a side view of device 800, and FIG. 8D is a side view of
the measurement member 802 of device 800 in isolation. Further,
FIG. 8A is a cross-sectional view of device 800 along the line
8A-8A shown in FIG. 8, and FIG. 8B is a cross-sectional view of
device 800 along the line 8B-8B shown in FIG. 8. Device 800
includes a measurement member 802 and an outer member 804.
Measurement member 802 includes a measurement scale 818 that has a
plurality of incremental markings. The incremental markings, in one
embodiment of device 800, extend for substantially the entire
length of measurement member 802. Outer member 804 includes an open
side 805, seen in FIG. 8A, through which measurement member 802,
and therefore the measurement scale 818, is visible while the
measurement member 802 is disposed within the outer member 804. The
open side 805 also includes two extensions 807 that cover an edge
of measurement member 802 while member 802 is disposed within outer
member 804. Extensions 807 secure measurement member 802 within
outer member 804 while simultaneously allowing for movement of
member 802 distally and proximally. Measurement member 802 also
includes a flange 806 located on its distal end. The flange 806 is
preferably a circular shape, a tear-drop shape, or another shape
that does not exhibit sharp angles.
[0103] In operation, measurement member 802 is placed within and is
slidably engaged by outer member 804. Measurement member 802 is
capable of being advanced distally and proximally while engaged by
outer member 804. In one exemplary use of device 800, device 800 is
used to measure the length of the cervix. When used to do so, the
device 800 is placed within the vagina and advanced distally until
the distal end of outer member 804 comes into contact with the
cervical-uterine junction. Then, the measurement member 802 is
advanced distally until flange 806 contacts the proximal surface of
the cervix, thereby preventing further distal movement of the
measurement member 802. A user measures the length of the cervix by
observing the location of the measurement scale 818 relative to the
proximal end of the outer member 804.
[0104] In one embodiment, the position of the measurement member
802 relative to the outer member 804 is maintained by friction
between the members. For example, in this embodiment, measurement
member 802 is manufactured to fit snugly within outer member 804,
but still allowing for movement distally and proximally while
engaged within outer member 804. The snug fit between the members
enables the maintenance of the position of measurement member 802
within outer member 804 after a measurement is recorded.
[0105] FIG. 9 illustrates another embodiment of a device of the
present invention, device 900. FIG. 9 is a top plan view of device
900, FIG. 9C is a side view of device 900, and FIG. 9D is a side
view of the measurement member 902 of device 900 in isolation. FIG.
9A is a cross-sectional view of device 900 along the line 9A-9A
shown in FIG. 9, and FIG. 9B is a cross-sectional view of device
900 along the line 9B-9B shown in FIG. 9. Device 900 is similar to
device 800 in that it includes a measurement member 902, having a
measurement scale 918 with a plurality of incremental markings, and
an outer member 904. Outer member 904 includes an open side 905,
seen in FIG. 9A, through which measurement member 902 and
measurement scale 918 is visible while measurement member 902 is
disposed within outer member 904. Measurement member 902 also
includes a flange 906 located on its distal end that is preferably
a circular shape, a tear-drop shape, or another shape that does not
exhibit sharp angles. Device 900 is also operable in substantially
the same manner as device 800.
[0106] Rather than the extensions 807 of device 800 that maintain
measurement member 802 within outer member 804, the outer member
904 of device 900 interlocks with measurement member 902. As seen
in FIGS. 9A and 9B, outer member 904 engages measurement member 902
without requiring extensions such as extensions 807 of device 800.
Here, measurement member 902 includes an angled body. Outer member
904 has angled space 903 configured to accept measurement member
902. Due to the interlocking fit of outer member 904 and
measurement member 902, measurement member 902 is capable of being
manipulated proximally and distally while disposed within angled
space 903 of outer member 904. Also, the interlocking fit of the
members allows for measurement member 902 to be slidably engaged by
outer member 904. During manufacture of device 900, outer member
904 may be crimped onto measurement member 902.
[0107] With regard to materials of manufacture, the devices of the
present invention are capable of being formed from either metallic
materials or plastic materials. In one embodiment, the devices are
manufactured from a metal, such as, e.g., brass, stainless steel,
aluminum, or the like, using techniques known in the art. When the
devices of the present invention are formed of a metallic material,
the devices are capable of being sterilized in order to allow a
device to be used repeatedly. Here, the devices are sterilized
using an appropriate means, including, e.g., chemical
sterilization, thermal sterilization, radiation, and the like,
after use in order to allow to extend the lifetime of the device.
In another embodiment, the devices of the present invention are
formed from a plastic material. With these embodiments, the devices
may be extruded from plastic using techniques known in the art.
When plastic is used to manufacture the devices, the devices are
disposable. Consequently, contamination issues are avoided by
virtue of producing devices that are designed to be disposed after
use, as compared to the embodiments formed with metal and requiring
sterilization. The relative reduced cost of utilizing plastics to
manufacture the devices, as opposed to metals, allows for the
plastic embodiments of the devices to be intended as disposable
units.
[0108] The present invention also provides various methods using
the devices. For example, the invention provides a method for
predicting the risk of preterm labor in an individual by performing
the following steps. First, a device that includes a measurement
member having a distal region and a proximal region, a hollow
member through which the measurement member is inserted and
advanced, and a flange engaged with the distal end of the hollow
member, is inserted into the vagina. The flange of the device has a
surface adapted to contact the cervix at the external uterine
opening after the distal end of the hollow member is inserted into
the vagina. The device is advanced within the vagina until the
flange contacts the cervix at the external uterine opening. At this
point, forward progress of the hollow member is prevented. The
measurement member is continued to be advanced until the distal
region of the measurement member contacts the cervical-uterine
junction at the fornix vaginae. Subsequently, the length of the
cervix in the fornix vaginae is determined by observing the
position of the proximal end of the hollow member along a
measurement scale located on the proximal portion of the
measurement member. The length of the cervix in the fornix vaginae
is inversely related to the risk of preterm labor.
[0109] As used herein the term "risk of preterm labor" refers to
the risk that an individual will enter labor before the
thirty-seventh week of gestation or pregnancy. Using the methods
and devices of the present invention, in certain circumstances this
risk can be predicted either when the individual is already
pregnant or when the individual is not pregnant. When it is
possible to evaluate the risk of preterm labor, a patient may gain
valuable insight on what may occur during the pregnancy. Also as
used herein the term "preterm delivery" is used interchangeably
with preterm birth and refers to birth of the fetus as the result
of preterm labor. Accordingly, it is contemplated that preterm
delivery would occur as the result of preterm labor. Because babies
born prematurely may have serious health problems, practitioners
try to avoid preterm labor it at all possible. If vaginal bleeding
occurs or if the fetal membranes rupture, preterm labor is
difficult to stop. If, however, vaginal bleeding does not occur,
and the membranes are not leaking amniotic fluid, bed rest with
fluid given intravenously helps approximately one in two women. It
should also be noted that if the cervix dilates beyond 5
centimeters, labor usually continues until the baby is born.
Typically, magnesium sulfate given intravenously stops labor in a
majority of cases. Using the devices and methods of the present
invention will indicate whether such treatment may be needed in the
future.
[0110] The invention also provides a method for predicting the risk
of miscarriage in an individual. First, a device that includes a
measurement member having a distal region and a proximal region, a
hollow member through which the measurement member is inserted and
advanced, and a flange engaged to the distal end of the hollow
member, is inserted into the vagina. The flange of the device has a
surface adapted to contact the cervix after the distal end of the
hollow member is inserted into the vagina. The device is advanced
within the vagina until the flange contacts the cervix, preferably
at the external uterine opening. At this point, forward progress of
the hollow member is prevented. The measurement member is continued
to be advanced until the distal region of the measurement member
contacts the cervical-uterine junction at the fornix vaginae.
Subsequently, the length of the cervix in the fornix vaginae is
determined by observing the position of the proximal end of the
hollow member along a measurement scale located on the proximal
portion of the measurement member. The length of the cervix in the
fornix vaginae is inversely related to the risk of miscarriage.
[0111] The present invention also provides methods for predicting
the ease of inducing labor. First, a device that includes a
measurement member having a distal region and a proximal region, a
hollow member through which the measurement member is inserted and
advanced, and a flange engaged to the distal end of the hollow
member, is inserted into the vagina. The flange of the device has a
surface adapted to contact the cervix after the distal end of the
hollow member is inserted into the vagina. The device is advanced
within the vagina until the flange contacts the cervix, preferably
at the external uterine opening. At this point, forward progress of
the hollow member is prevented. The measurement member is continued
to be advanced until the distal region of the measurement member
contacts the cervical-uterine junction at the fornix vaginae.
Subsequently, the length of the cervix in the fornix vaginae is
determined by observing the position of the proximal end of the
hollow member along a measurement scale located on the proximal
portion of the measurement member. The length of the cervix in the
fornix vaginae is inversely related to the ease of inducing
labor.
[0112] The invention further provides a method for assessing the
fertility of an individual. First, a device that includes a
measurement member having a distal region and a proximal region, a
hollow member through which the measurement member is inserted and
advanced, and a flange engaged to the distal end of the hollow
member, is inserted into the vagina. The flange of the device has a
surface adapted to contact the cervix after the distal end of the
hollow member is inserted into the vagina, includes a measurement
scale, and is substantially translucent. Also, the flange is
preferably off-set to the side of the hollow member to allow the
flange to cover the external uterine opening while also allowing
for the further advancement of the measurement member toward the
fornix. The device is advanced within the vagina until the flange
contacts the cervix, and preferably is placed against the external
uterine opening. At this point, forward progress of the hollow
member is prevented. The measurement member, however, is continued
to be advanced toward the fornix until the distal region of the
measurement member contacts the cervical-uterine junction at the
fornix vaginae. Subsequently, the length of the cervix in the
fornix vaginae is determined by observing the position of the
proximal end of the hollow member along a measurement scale located
on the proximal portion of the measurement member. Additionally,
the dilation of the cervix is measured using the measurement scale
on the flange. The length of the cervix in the fornix vaginae is
inversely related to the fertility of an individual.
[0113] As used herein, the term "fertility" refers to the ability
of a female to carry a fetus to the point where it is viable or can
survive with the help of medical science, if necessary, when
delivered, a female attempting pregnancy, preconceptional
evaluation, or procedures involved with infertility treatment.
Accordingly, fertility generally refers to the ability of a female
to carry a fetus to a normal nine month term, as well as to any
other shorter term where the infant would survive on its own or
with critical care. By assessing the cervical length and diameter,
a practitioner may achieve an appreciation of the fertility of the
female, because a risk for preterm labor can be predicted. For
example, if the practitioner can determine that a female is at risk
for preterm labor and preterm delivery, and that the infant's
chances for survival would be small, then the practitioner can
advise the female of the risk. Accordingly, the female can make the
decision to avoid pregnancy or can, with the assistance of her
physician; take steps through diet, rest, and medications to lessen
the risk of preterm labor.
[0114] As used herein the term "female" refers to a mammalian
female, such as a human, horse, dog, cow, pig or monkey. Although
the devices and methods are particularly adapted for use in a human
female, one skilled in the art understands that they may be used in
any female mammal. Accordingly, the devices and methods of the
present invention could be used in veterinary medicine, if desired.
When used in veterinary medicine, the devices and methods are
specifically adapted for the type of animal on which the devices
and methods will be used. For example, a device of the present
invention adapted for equine use will include a hollow member and a
measurement member that is greater in length relative to a device
adapted for human use. The hollow member and the measurement member
must both be of a sufficient length to enable a veterinarian to
measure the length of the cervix, the dilation of the cervix, and
the depth of the uterus of a female horse. Since the equine vaginal
canal is longer than a human vaginal canal, both the hollow member
and the measurement member of the devices of the present invention
must accordingly be longer when adapted for equine use.
EXAMPLE I
Cervix Length Measurement
[0115] This example provides measurement of the length of the
cervix in the vagina in a subject and correlation with reported
criteria for determining the risk of preterm delivery.
[0116] The subject preferably lies in a prone position on her back.
In one procedure, the practitioner uses a speculum to first examine
the vaginal cavity and to observe the optimum position for placing
the device. The practitioner then inserts into the vagina a device
that includes a measurement member having a distal region and a
proximal region, a hollow member through which the measurement
member is inserted and advanced, and a flange engaged to the distal
end of the hollow member. Alternatively, the practitioner may
insert the device into the vagina without first using the speculum.
The flange of the device has a surface adapted to contact the
cervix at the external uterine opening after the distal end of the
hollow member is inserted into the vagina. The practitioner next
advances the hollow member within the vagina until the flange
contacts the cervix at the external uterine opening. At this point,
forward progress of the hollow member is prevented. The
practitioner then progresses the measurement member through the
hollow member until the distal region of the measurement member
contacts the cervical-uterine junction at the fornix vaginae.
Subsequently, the practitioner determines the length of the cervix
in the fornix vaginae by observing the position of the proximal end
of the hollow member along a measurement scale located on the
proximal portion of the measurement member. Since the length of the
cervix in the fornix vaginae is inversely related to the risk of
preterm delivery, the practitioner is then able to determine that
risk in the patient. The practitioner uses the data provided herein
in Table 1, discussed in Iams et al., N. Eng. J. Med. 334:567
(1996); which is incorporated by reference herein, in order to
determine the relative risk of preterm delivery. TABLE-US-00001
TABLE I Relative Risk of Preterm Delivery Length of cervix (mm)
Percentile at 24 weeks at 28 weeks 40 .ltoreq.75 2 2.8 35
.ltoreq.50 2.4 3.5 30 .ltoreq.25 3.8 5.4 26 .ltoreq.10 6.2 9.6 22
.ltoreq.5 9.5 13.9 13 .ltoreq.1 14 24.9
[0117] As used herein, the term "relative risk" refers to the
likelihood that there will be a preterm delivery when compared to
the population that does not have that finding. In this subject,
the length of the cervix is determined to be 22 mm. Since the
subject is at 24 weeks of gestation, the relative risk for preterm
delivery for this subject is 9.5. In other words, this subject has
a 9.5 higher risk for preterm delivery than an individual whose
cervix is greater than 22 mm in length.
EXAMPLE II
Cervix Dilation Measurement
[0118] This example demonstrates the use of the invention disclosed
herein to measure the dilation of the cervix uteri in the same
subject as in Example 1, to predict the risk for preterm delivery
or the particular stage of delivery in a normal pregnancy.
[0119] One of the devices of the present invention is used to
measure the dilation of the cervix uteri. A physician inserts into
the vagina a device that includes a measurement member having a
distal region and a proximal region, a hollow member through which
the measurement member is inserted and advanced, and a flange
engaged to the distal end of the hollow member. The flange of the
device has a surface adapted to contact the cervix after the distal
end of the hollow member is inserted into the vagina, includes a
measurement scale, and is substantially translucent. Also, the
flange is preferably off-set to the side of the hollow member to
allow the flange to cover the external uterine opening while also
allowing for the further advancement of the measurement member
toward the fornix. The device is advanced within the vagina until
the flange contacts the cervix at the external uterine opening. The
physician then measures the dilation of the cervix by comparing the
dilation of the cervix with the measurement scale on the flange.
Using this procedure, the dilation of the cervix uteri is this
subject is found to be 5 cm. Accordingly, the physician advises the
subject that delivery is imminent. Since this subject is in her
24.sup.th week of pregnancy, this delivery is premature or
preterm.
[0120] Although the invention has been described with reference to
the examples provided above, it should be understood that various
modifications can be made without departing from the spirit of the
invention. Accordingly, the invention is limited only by the
claims.
* * * * *