REFERENCE TO RELATED CASE
FIELD OF THE INVENTION
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.
- BACKGROUND OF THE INVENTION
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.
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.
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.
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.
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.
- OBJECTS OF THE INVENTION
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.
BRIEF DESCRIPTION OF THE INVENTION
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.
FIG. 1 is a side sectional elevation view of a vaginal speculum of the invention with a sliding removable ruler built into one blade of the vaginal speculum.
FIG. 2 is a cross-sectional view along the line II-II of the speculum of FIG. 1.
FIG. 3 is a rear view of the speculum of FIG. 1 in the direction of arrow A.
FIG. 4 is a top view on a sliding removable ruler built into one blade of the vaginal speculum shown in FIG. 1.
FIG. 5 is a sectional view of normal reproductive organs of a woman with the speculum inserted to the vagina.
FIG. 6 shows an example of cystocele inside the vaginal canal.
SUMMARY OF THE INVENTION
FIG. 7 shows a condition of a uterine prolapse protruding outside the vagina [ANANIAS! CHECK THIS STATEMENT. IS THIS A UTERINE PROLAPSE?].
- DETAILED DESCRIPTION OF THE INVENTION
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.
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.
As can be seen from FIG. 1, which is a side elevation view of the speculum 20 of the invention, the speculum 20 comprises a fixed blade member 22, a slide member 24, and a movable blade member 26. Herein, the term “moveable” means pivotally rotatable with respect to the fixed blade member 22. It should be noted that the speculum of the type corresponding to U.S. Pat. No. 3,716,047 is shown only as an example and that the principle of the invention can be realized in any other vaginal speculum having pivotally interconnected blades.
The fixed blade member 22 has an L-shaped configuration with a blade portion 22 a insertable into the patient's vagina, and a handle portion 22 b substantially perpendicular to the blade portion 22 a. The blade portion 22 a is hollow and, as can be seen from FIG. 2, which is a sectional view along line II-II in FIG. 1, it has a semicircular cross-section. The distal end 23 of the blade portion 22 a, i.e., the end opposite to the handle portion 22 a, is rounded.
Ratchet teeth 30 are formed on the lower rear side of the handle portion 22 b for the purposes explained later. The part of the handle portion 22 b located above the teeth 30 may have a slot shown by a broken line 32 in FIG. 1. This slot serves for guiding a complementary shaped part of the slide member 24.
The slide member 24 of the vaginal speculum 20 of the present invention has a fork-like straight portion 34 shown in FIG. 3, a rearward projection 36 which is substantially perpendicular to the straight portion 34 and has teeth 38 on one of its sides, and a tail portion 40 with a pawl 42 for engagement with ratchet teeth 30. FIG. 3 is a rear view of the vaginal speculum 20 of the invention in the direction of arrow A in FIG. 1. As can be seen from FIG. 3, the fork-like portion 34 of the slide has holes 44 and 46 on the inner sides of fork legs 34 a and 34 b. These holes receive projections 43 and 45 formed on the outer side walls of the proximal part 25 of the movable member 26. As a result, the movable member 26 can perform rotating or swinging movements around projections 43 and 45 as pivot points.
Similar to the fixed member 22, the movable member 26 has an L-shaped configuration (FIG. 1) with a blade portion 26 a insertable into the patient's vagina and a trigger portion 26 b formed on the proximal end 25 of the speculum and oriented substantially perpendicular to the blade portion 26 a. The insertable blade portion 26 a of the moveable member 26 is symmetrical to the insertable blade portion 22 a of the fixed member 22 and is complementary thereto so that in a closed state of the speculum 20 shown in FIG. 1 both blade portions form a substantially round cross section shown in FIG. 2.
As shown in FIG. 2, the moveable blade member 26 has, on the inner side, a longitudinal guide channel 50 which passes through the entire length of the moveable blade member 26 without separating it into two parts due to a solid portion 29 that remains at the distal end 23 of the blade 26. Longitudinal guide slits 27 a and 27 b are formed in wall of the moveable member 26 on the mutually facing sides of the guide channel 50.
The moveable blade member 26 provided with a measurement ruler 52 that has outwardly projecting edges 31 a and 31 b slidingly inserted into the longitudinal guide slits 27 a and 27 b of the moveable blade member 26 (FIG. 2) so that the measurement ruler can slide back and forth in the direction shown by the two-headed arrow C in FIG. 4, which is a top view on a sliding removable ruler built into the blade member 26 of the vaginal speculum shown in FIG. 1. In FIG. 4, the measurement ruler is shown in a non-extended position. An extended position 52′ of the ruler 52 is shown by broken lines in FIG. 1. It is seen from FIG. 2, that in a cross-section of the blade portion of the vaginal speculum 20, the longitudinal guide channel 50 is closed by the measurement ruler 52 so that, in combination with the remaining outer surface of the blade, the outer surface 53 of the measurement ruler 52, forms a complete circle.
On its proximal end, the ruler 52 has a tab 55, which is used for pushing the ruler 52 forward when the ruler is used for measuring positions and severity of vaginal prolapses. It is understood that the distance L (FIG. 1) from the tab 55 to the rear or proximal end 25 of the moveable blade 66 should be sufficient to make all necessary inside and outside of the vagina.
As can be seen from FIG. 4, the sliding measurement rules has a scale 56, while a complementary scale or scales 58 and 60 can be formed on the outer surface of the moveable blade member 26. The numbers of the scales may have different arrangements. For example, in the embodiment shown in FIG. 4, the numbers on the ruler increase in the direction from the distal end 23 towards the proximal end 25 of the moveable blade 26. For convenience in use and in selection of the reference points for measurements, the scale 58 may have numbers increasing in the direction opposite to that for the numbers on the scale of the measurement ruler, while the scale 60 may have numbers increasing in the same direction as the numbers on the ruler 52.
As shown in FIGS. 1 and 3, the trigger portion 26 b has an opening 26 g with a tooth 26 k on the solid part of the trigger 26 b for engagement with the teeth 38 on the projection 36 (FIG. 1). The tooth 26 k and teeth 38 may be formed as ratchet teeth and a pawl so that pushing on the trigger 26 in the direction of arrow A will rotate the movable member 26 on pivot projections 43 and 45 for expanding the speculum blades 22 and 26. Due to the ratchet engagement between the teeth 26 k and 38, after the trigger is releases, the blades 22 and 26 will remain in the expanded position 20′ shown in FIG. 1 by the broken line.
Procedure for the use of the Vaginal Speculum with a Sliding Measurement Ruler
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.
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 FIGS. 1 through 4, the insertable blade portions 26 a and 22 a of the blade members 22 and 26 are then lubricated using a water-soluble lubricant. The insertable ends 26 a and 22 a of the speculum 20, are then gently inserted into the vaginal canal in a closed state of the speculum 20 shown in FIG. 1, and are advanced all the way to the vaginal vault or at the level of the uterine cervix 101, shown in FIG. 5, which is a sectional view of normal reproductive organs of a woman.
If necessary, after insertion of the blades into the vagina, as shown in FIG. 5, the physician can measure the length of the vagina. This measurement can be made by reading the numbers on one of the scales 56, 58, 60 and by manipulating with the measurement ruler 52. After measuring the length of the vagina or the distance LI from the hymeneal ring 103 to the vault 100 in a closed state of the blades, the physician will then expand the speculum by pushing on the trigger portion 26 b so that the teeth 26 k slide in a ratchet manner over the teeth 38 of the projection 36. As a result, the blade members 22 and 26 of the speculum assume the positions shown by broken lines in FIG. 1. The speculum is then slowly retracted away from the vagina. If a prolapse appears, the blades are moved further away from the vagina to point at which the prolapse P is entirely exposed. The movement of the speculum and hence of the blades is then discontinued with the position of the tips of the blade 26 at the distal edge 105 of the prolapse P, i.e., at distance L2 from the hymeneal line 103. The ruler 52 is then moved forward to the proximal edge 107 of the prolapse P. In this position, which is shown in FIG. 6, the tip of the ruler 52 is located from the distal edge 105 of the prolapse at the distance L3 (FIGS. 6). Thus, knowing the length of the vagina L1 and the distances L2 and L3, one can now determine the distance L4 from the proximal edge 107 of the prolapse P to the vault 100 by subtracting L2+L3 from L1.
If the prolapse is so severe that, as shown in FIG. 7, it is coming out of the vaginal opening which can be observed even before the speculum is inserted or after the speculum is completely removed and the organ prolapsing (for example, the uterine prolapse 110 is protruding out), then the measurement of the prolapse will be a distance L5 from the hymeneal line 103 to the furthest tip of the prolapsing part. This distance is measured by means of the scale on the tip of the measurement ruler 52.
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 52 and using the scales on the blades and on the ruler. The speculum and the ruler can be made of metal or plastic. The speculum may be a disposable instrument, the ruler can be replaceable. The specula and the rulers can be made with different width, length, or shape. They can be disposable, or have replaceable rulers, etc. The sliding ruler can be provided in the lower blade or in both blades.