Cervix measuring device and method

A cervix measuring device is provided including an elongated shaft having a proximal end and a distal end, a positioning member slidably carried by the elongated shaft, the positioning member having a semicircular shape to allow partially encirclement of a base of a ectocervix, and a stop member stopping the positioning member from sliding past the distal end of the elongated shaft.

FIELD OF THE INVENTION

This invention relates to medical devices.

More particularly, the present invention relates to devices for measuring the length of the cervix.

BACKGROUND OF THE INVENTION

In the field of obstetrics, measurements taken of the cervix are important during pregnancies. Dimensions of the cervix at various times throughout a pregnancy are indicative of how the pregnancy is progressing. There are essentially four methods that can be used to evaluate the uterine cervix: digital examination, transabdominal ultrasound, transperineal ultrasound (TPS) and transvaginal sonography (TVS). Digital examination provides the most comprehensive evaluation of the cervix, assessing dilatation, position, consistency and length. However, this examination suffers from being subjective. The other types, while accurate, are expensive, require sophisticated equipment, and are time consuming. Recently, devices have been developed as a replacement for digital examination. These devices include rigid elongated elements inserted into the vagina to the base of the cervix. While effective, these devices require the use of a speculum to enable insertion of the device and viewing of the ectocervix to allow proper placement of the device. If the device is improperly positioned, the end of the device may be inadvertently inserted into the external os of the cervix. Inadvertent insertion of the end of the device into the external os can result in injury and damage. While less expensive than many current methods, the requirement of a speculum for use increases the time and expense of the procedure.

An object of the present invention is to provide a device for measuring a cervix without use of a speculum.

Another object of the present invention is to provide a cervix measuring device to assist in digital examination.

SUMMARY OF THE INVENTION

Briefly, to achieve the desired objects and advantages of the present invention provided is a cervix measuring device. The cervix measuring device includes an elongated shaft having a proximal end and a distal end, a positioning member slidably carried by the elongated shaft, the positioning member having a semicircular shape to allow partially encirclement of a base of a ectocervix, and a stop member stopping the positioning member from sliding past the distal end of the elongated shaft.

The positioning member can include a collar member slidably received on the elongated shaft. A first curved arm extends from the collar member in a first direction, and a second curved arm extends from the collar member in an opposing direction. The elongated shaft is formed of a flexible material being sufficiently flexible to deform and conform to the shape of an inserting hand and to the shape of a vagina in which it is inserted.

Also provided is a method of measuring a cervix. The method includes the step of providing a cervix measuring device including an elongated shaft having a proximal end and a distal end, a positioning member slidably carried by the elongated shaft, the positioning member having a semicircular shape, and a stop member stopping the positioning member from sliding past the distal end of the elongated shaft. The method further incudes the steps of positioning member proximate the distal end, conforming the elongated shaft to the shape of a hand and inserting the distal end and the positioning member of the cervix measuring device into a vagina using the hand. The positioning member is used to locate and partially encircle the ectocervix by feel. The cervix measuring device is then inserted until the distal end is placed against a vaginal wall adjacent the ectocervix, guided into position by the positioning member. Once properly positioned with the distal end against the vaginal wall adjacent the ectocervix, the position is maintained while moving the positioning member toward the proximal end until it is positioned adjacent the tip of the ectocervix.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

Turning now to the drawings in which like reference characters indicate corresponding elements throughout the several views, attention is directed toFIG. 1which illustrates a cervix measuring device generally designated10, positioned to take a measurement within a portion of a female reproductive system. The portions of the female reproductive system specifically illustrated include a uterus12, a cervix14and a vagina15. Vagina15is a canal that connects cervix14to the outside of a female body and through which device10extends. Cervix14is a cylinder-shaped neck of tissue that connects vagina15and uterus12. Located at the lowermost portion of uterus12, cervix14includes two main portions, an ectocervix17, the part of cervix14that protrudes into vagina15and which can be seen from inside vagina15during a gynecologic examination, and an external os18, an opening in the center of ectocervix17. External os18opens to allow passage between uterus12and vagina15. A fornix vaginae19is an area at the base of vagina15into which cervix14protrudes.

Cervix measuring device10is employed to measure the length of ectocervix17. Stated another way, device10is used to measure the length of cervix14in the fornix vaginae. Also used herein, the term “fornix vaginae” refers to the recess formed between the vaginal wall and ectocervix17. The fornix vaginae may be divided into pars anterior (the anterior fornix), the pars posterior (posterior fornix) and the pars lateralis (lateral fornix), depending on its relation to the walls of vagina15. Measuring device10can be inserted into any of these parts of the fornix vaginae, depending on the choice of the user, to determine either the depth of the fornix vaginae at any particular point, or the length of ectocervix17in the fornix vaginae.

With additional reference toFIG. 4, measuring device10includes an elongated shaft20having a proximal end22and a distal end24. For purposes of this description, proximal end22is the end of measuring device10proximate the user, and distal end24is the end of measuring device10first inserted into vagina15. Elongated shaft20is preferably formed of a flexible material to permit manipulation thereof within vagina15. Elongated shaft20can have substantially any cross-sectional shape, such as square, round, oval and the like, and is preferably formed of a biologically inert plastic material. While previous devices require the use of a speculum to enable insertion of the device and viewing of the ectocervix to allow proper placement of the device, the present invention is intended to be employed without the use of a speculum. By eliminating the use of a speculum, the cost of the procedure and the time involved for the procedure can be reduced. Without a speculum, a user inserts elongated shaft20into vagina15by feel alone. To insure proper placement of distal end24, a positioning member30is slidably carried by shaft20.

With additional reference toFIG. 6, positioning member30has a curved or semicircular shape to allow it to partially encircle the base of ectocervix17. A curved arm32extends from a collar member35in one direction, and a curved arm36extends from collar member35in an opposing direction. Collar member35includes an aperture38extending therethrough. Aperture38receives shaft20therethrough and provides the frictional engagement therewith. This semicircular shape ensures that distal end24is properly positioned to the side of ectocervix17, and prevents any possibility of distal end inadvertently being inserted into external os18. Inadvertent insertion of distal end into external os18can result in injury and damage.

Referring back toFIGS. 2 and 3, at the beginning of the procedure, positioning member30is positioned proximate distal end24. As can be seen with momentary reference toFIG. 7, distal end24is preferably flattened to a button member33, having slightly extending sides to provide non-abrasive contact to the vaginal wall, and to prevent positioning member30from sliding off shaft20. It will be understood that while button member33is the preferred stop member of the present invention, a slight widening of distal end24and the like, can also be employed as a stop member to prevent positioning member30from being removed from distal end24. Shaft20and positioning member30are then inserted into vagina15until button element33at distal end24is placed against the vaginal wall in the fornix vaginae adjacent ectocervix17. Elongated shaft20is sufficiently flexible to permit insertion into, and conformation thereof to the shape of vagina15. The flexibility of shaft20allows a user to insert distal end24along with a hand and fingers, with shaft20conforming to the shape of the hand and vagina15. Since positioning of distal end24is not observable, positioning member30is used by feel to encircle ectocervix17, properly positioning device10. Once distal end24is positioned properly against the vaginal wall adjacent ectocervix17, the user can slide positioning member30toward proximal end22until it is positioned adjacent the tip of ectocervix17(illustrated in broken line inFIG. 3). Positioning member30is then held in position by frictional engagement with shaft20or by a locking mechanism such as detents, clamps and the like. Device10is then withdrawn from vagina15and the distance between distal end24and positioning member30indicates the length of ectocervix17as shown inFIG. 7. Measuring indicia34can be carried by elongated shaft20proximate distal end24to provide a measuring scale.

Turning toFIGS. 6 and 7, positioning member30includes curved arms32and36extending outwardly from a collar35. Collar35includes an aperture38therethrough for slidably receiving shaft20. Collar35can include a friction engagement with shaft20which needs to be overcome to slidably position positionable member30. A locking mechanism can be provided in the place of the simple friction arrangement. In a friction arrangement, positioning member30can be slidably moved along shaft20from distal end24toward proximal end22. The movement caused by the user's fingers overcoming the friction between shaft20and positioning member30. When positioning member30is positioned as desired, device can be removed with positioning device30held in position by friction. Various types of locking mechanism can also be employed. These include a clamp carried by collar35of positioning member30and releasably clampable to shaft20, a deformable collar35which can be deformed inwardly against shaft20to prevent further movement, detents, or the like. The locking mechanism is movable between an engaged and a disengaged position, retaining positioning member30in position in the engaged position and allowing sliding movement of positioning member30in the disengaged position.

Turning now toFIG. 5, measuring device10can be fitted with a stiffening cover40. Stiffening cover40is a slotted tube in the preferred embodiment, which can be fitted over shaft20to render shaft20stiffer. This is an option that allows measuring device10to be used in combination with a speculum. When a speculum is employed, insertion of a hand directing distal end24is unnecessary. In this case, a visual position is possible. However, shaft20must be stiffened to allow positioning when grasping proximal end22. Additionally, cover40can be slidably carried by shaft20. In this manner, cover40can be grasped, and shaft20slidably manipulated as desired.