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.
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.
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.
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.
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.
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 findus 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.
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.
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.
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.
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.
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.
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.
The present invention provides devices and methods for determining a dimension of a female reproductive organ.
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.
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.
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.
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.
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.
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.
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.
Other objects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
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