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[0001] This application is continuation of U.S. patent application Ser. No. 09/565,613 filed May 4, 2000 for which Notice of Allowance was granted.
[0002] The present invention relates to medical diagnostic instruments, in particular to a vaginal speculum for visual examination of the vaginal cavity, vaginal walls, and conditions of the cervix. More specifically, the invention relates to a vaginal speculum equipped with means for measuring severity and positions of vaginal prolapses, or for fulfilling other vaginal measurements associated with urological or gynecological procedures.
[0003] A vaginal speculum is a diagnostic instrument for dilating the opening of the vagina cavity in order that the interior may be more easily visible for observation. A vaginal speculum has two expandable blades, which are inserted into the vagina in a closed state and then expanded, or moved apart for dilating the vaginal cavity. In particular, a vaginal speculum is an indispensable instrument not only for gynecologists and urologists but also for primary care physicians, geriatricians, and nurse practitioners for examination of patients suffering from urinary incontinence in order to exclude the presence of vaginal prolapses, such as rectocele, cystocele, enterocele, and uterine prolapse. Vaginal prolapses of the aforementioned type are protrusions or herniations of the urethra or other pelvic organs into the vagina.
[0004] One typical vaginal speculum is described in U.S. Pat. No. 3,716,047. The instrument consists of three parts of molded non-toxic plastic materials, i.e., a fixed member, a movable member, and a sliding member. The sliding member is slidingly installed in the fixed member and pivotally supports the movable member so that the movable member can be rotated around the pivot at the proximal end of the fixed member. As a result, the distal ends of the movable and fixed members, which form expandable blades insertable into the vagina, can dilate the vagina cavity and thus allow internal vaginal observations. The members are made from a transparent plastic and the blades form a thin-wall circular or oval cross-section, which allows the observation.
[0005] Conventional vaginal specula, however, do not have features for measuring the length of vagina and for testing and measuring the severity of the prolapses without completely removing the entire speculum. Normally, the physician disassembles the speculum and inserts only one of the blades for pressing on one wall of the vagina for exposing and observing the opposite wall. In case of prolapses, a separate ruler, i.e., an instrument separate from the speculum, is used for measuring the length of vaginal and the length and position of the prolapse or prolapses. The procedure is then repeated for expositing the opposite wall of the vagina cavity. In some cases, the physician uses a separate single metal blade for pressing on the anterior and posterior walls of the vagina cavity. Thus, the examination involves the use of several instruments, as well as assembling and disassembling operations. Thus, it is impossible with conventional specula to conduct measurements and the use of separate measurement instruments is required.
[0006] The above problems can be solved with the use of a vaginal speculum having removable blades described in U.S. patent application Ser. No. 09/565,613 filed by the same applicants on May 4, 2000, for which a Notice of Allowance was recently granted. In general, the aforementioned vaginal speculum is similar to a conventional one in that it consists of two blades pivotally interconnected through a fork-like member so that the blades can be expanded and fixed in an expanded state in order to dilate the vagina for observing the condition of the vagina cavity. However, this speculum has removable blades, which can be partially withdrawn or completely removed without withdrawing the entire speculum from the vagina. Provision of retractable blades makes it possible for a physician to withdraw the blades in an alternating sequence for exposing one of the walls of the vagina cavity by pressing down with the longer blade on the opposite wall. The blades are made from a transparent material and have scales applied onto the outer surface of the upper blade and onto the inner surface of the lower blade, so that the physician can perform measurements required for determining positions and severity of vaginal prolapses or any other measurements associated with vaginal examinations or treatment procedures.
[0007] Although the aforementioned vaginal specula with completely removable blades are convenient for urological and gynecological examination of patients with regard to the presence of vaginal prolapses, such as rectocele, cystocele, enterocele, and uterine prolapse, just for vaginal measurements and for simple examination procedures it would be preferable to have a vaginal speculum of less expensive and less complicated construction.
[0008] It is an object of the present invention to provide a vaginal speculum equipped with a sliding removable measurement tool built at least into one of speculum blades. It is another object to provide a vaginal speculum of the aforementioned type which is simple in construction, easy to operate, and inexpensive to manufacture. Another object is to provide a disposable vaginal speculum with a sliding removable ruler, which slides along the inner surface of the blade without violating the smoothness of the outer blade surface. Still another object is to provide a vaginal speculum of the aforementioned type with scales on the ruler and on the outer surface of the transparent blade in which the ruler slides. Another object is to provide a vaginal speculum for simple examination procedures and mainly for vaginal measurements.
[0009]
[0010]
[0011]
[0012]
[0013]
[0014]
[0015]
[0016] A vaginal speculum consisting of two blades pivotally interconnected through a fork-like member so that the blades can be expanded and fixed in an expanded state in order to dilate the vagina for observing the condition of the vaginal cavity. The device is characterized by having a removable ruler, which slides in guides formed on the inner surface of at least one of the blades and can be withdrawn partially or completely or shifted forward beyond the limits of the distal end of the blade. The ruler has a scale applied onto its surface. The blade is made from metal or a transparent plastic and also may have a scale for use separately or in combination with the scale of the ruler. The vaginal speculum with a removable ruler can be used for measuring severity and positions of vaginal prolapses or for other measurements associated with urological or gynecological procedures without the use of additional instruments.
[0017] In general, a vaginal speculum of the present invention is similar to the one described in U.S. Pat. No. 3,716,047, which is incorporated herein by reference, and is aimed at its improvement, as well as at an improvement of any other vaginal speculum of the type having two blades which are expanded by rotating around a pivot at their proximal ends.
[0018] As can be seen from
[0019] The fixed blade member
[0020] Ratchet teeth
[0021] The slide member
[0022] Similar to the fixed member
[0023] As shown in
[0024] The moveable blade member
[0025] On its proximal end, the ruler
[0026] As can be seen from
[0027] As shown in
[0028] Procedure for the use of the Vaginal Speculum with a Sliding Measurement Ruler
[0029] The procedure is started from inspection of the vaginal introitus to determine the status of the vaginal skin, the size of the vaginal outlet, and the presence or absence of pelvic organ prolapse. A vaginal speculum of a required size with a measurement ruler is then chosen.
[0030] Since a vaginal speculum is normally a disposable instrument, which is sterilized and packed into a sealed package, it is unpacked and removed from the package. In the case of the speculum of
[0031] If necessary, after insertion of the blades into the vagina, as shown in
[0032] If the prolapse is so severe that, as shown in
[0033] It is understood that the measurements described above were given only as an example and that any other measurements such as determination of rectocele, cystocele, enterocele, uterine prolapse, etc., can be made by manipulating the ruler