Abstract:
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having a removable ruler, which slides in guides formed on the inner surface of at least one of the blades and can be withdrawn partially or completely or shifted forward beyond the limits of the distal end of the blade.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.

Description:
REFERENCE TO RELATED CASE  
       [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. 
     
    
     
       FIELD OF THE INVENTION  
         [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.  
         BACKGROUND OF THE INVENTION  
         [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.  
         OBJECTS OF THE INVENTION  
         [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. 
       
    
    
     BRIEF DESCRIPTION OF THE INVENTION  
       [0009]    [0009]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.  
         [0010]    [0010]FIG. 2 is a cross-sectional view along the line II-II of the speculum of FIG. 1.  
         [0011]    [0011]FIG. 3 is a rear view of the speculum of FIG. 1 in the direction of arrow A.  
         [0012]    [0012]FIG. 4 is a top view on a sliding removable ruler built into one blade of the vaginal speculum shown in FIG. 1.  
         [0013]    [0013]FIG. 5 is a sectional view of normal reproductive organs of a woman with the speculum inserted to the vagina.  
         [0014]    [0014]FIG. 6 shows an example of cystocele inside the vaginal canal.  
         [0015]    [0015]FIG. 7 shows a condition of a uterine prolapse protruding outside the vagina [ANANIAS! CHECK THIS STATEMENT. IS THIS A UTERINE PROLAPSE?]. 
     
    
     SUMMARY OF THE INVENTION  
       [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.  
       DETAILED DESCRIPTION OF THE INVENTION  
       [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 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.  
         [0019]    The fixed blade member  22  has an L-shaped configuration with a blade portion  22   a  insertable into the patient&#39;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.  
         [0020]    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 .  
         [0021]    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.  
         [0022]    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&#39;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.  
         [0023]    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 .  
         [0024]    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.  
         [0025]    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.  
         [0026]    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 .  
         [0027]    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.  
         [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 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.  
         [0031]    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 L 2  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 L 3  (FIGS. 6). Thus, knowing the length of the vagina L 1  and the distances L 2  and L 3 , one can now determine the distance L 4  from the proximal edge  107  of the prolapse P to the vault  100  by subtracting L 2 +L 3  from L 1 .  
         [0032]    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 L 5  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 .  
         [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  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.