Using a Sheathed Speculum to Visualize and Access the Cervix in Women With Excessive Vaginal Tissue

This new invention addresses the inadequate and incomplete visualization of the cervix in
patients with excessive vaginal tissue. In general these patients are obese, or are
multiparous with a history of multiple vaginal deliveries.

A vaginal speculum is a vital medical instrument that allows a health care provider to
visualize the interior aspects of the vagina, as well as the distal portion of the uterus,
the cervix. It is composed of 2 blades assembled together and held by a handle. The blades
and the handle form a 90 degree-angle. As the user holds the handle, a lever attached to the
top blade allows it to open away from the inferior blade.

When the instrument is inserted into the vagina, the two blades are separated in order to
keep the anterior and posterior vaginal walls apart. In that position, the cervix and the
walls of the vagina can be seen if the patient does not have an excess of loose vaginal
tissue. However, in patients with excessive tissue, the sidewalls of the vagina simply
collapse toward the midline between the blades because of the fact that no part of the
speculum is in direct contact with the lateral walls of the vagina. This collapse prevents
the complete and crucial visualization of the cervix for purposes of cervical cultures, pap
smears, visual assessment of ruptured membranes, visual assessment of the degree of
dilation, biopsies, and other procedures requiring access to the cervix or the uterus.

When clinicians face this dilemma, they may try the largest speculum available, and will
open it as wide as possible in order to keep the lateral walls apart. Most often, they have
to improvise by cutting the tip of a condom, or the thumb off a glove, or they use a sterile
lateral-wall retractor. These other creative solutions can take several minutes of precious
times and may still result in an inadequate visualization and suboptimal access.

A vaginal speculum sheath for retaining vaginal tissue in a lateral direction conforms to a
pair of blades that are movable between an opened position and a closed position. The blades
in the closed position are adapted for insertion into a vagina, and in the open position,
they allow dilating the vagina in order to provide access to the cervix.

This new design includes a flexible, transparent polyurethane sleeve structure that extends
between the blades when the speculum is opened. The stretched sheath is adapted to retain
the lateral walls of the vagina in the open position. The elastic sleeve is designed to
remain in a collapsed configuration when the blades are in a closed position to avoid
interfering with insertion or withdrawal of the speculum [Reference: U.S. patent 6432048
(2002-8-13)]. Polyurethane material is FDA approved for vaginal use.

The purpose of this study is to compare standard of care speculum vs. sheathed speculum in
the examination of patients with collapsing vaginal sidewalls during a gynecological
speculum exam.

The primary hypothesis testing for this study will be to compare the standard of care
speculum exam to a sheathed speculum exam in a prospective, randomized clinical trial.