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 vagina cavity. The device is characterized by having adjustable blades, which can be withdrawn partially or completely for replacement with blades of other dimensions without withdrawing the entire speculum from the vagina. In a closed state, the distal ends of the blades form a bifocal lens, which can be used for visually detecting changes, associated with an earlier stage of cancer or erosion. 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.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     “Not Applicable”. 
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     “Not Applicable”. 
     REFERENCE TO “MICROFICHE APPENDIX” 
     “Not Applicable”. 
     BACKGROUND OF THE INVENTION 
     1. Field 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. 
     2. Description of the Related Art 
     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 but also for primary care physicians, geriatricians, urologists, and nurse practitioners for urological 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 herniation 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. 
     A procedure of examination of a vagina with the use of a speculum involves movements of the speculum in an expanded, i.e., an outwardly diverging state in the direction towards or away from the uterus. This is necessary for diagnosing aforementioned vaginal prolapses. However, since the opening of the vagina has a circular muscle, which is more resistant to dilations than the vaginal cavity, the aforementioned withdrawal of the expanded speculum may cause in patient discomfort and painful sensations. This is because in the course of the withdrawal of the speculum the diameter of its portion at the vaginal opening is stretched by the speculum. Furthermore, the conventional vaginal specula 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 is used for measuring 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 tools, as well as assembling and disassembling operations. Thus, it is impossible with conventional specula to conduct more concentrated and localized examination of one wall of the vaginal cavity without removing the entire speculum from the vagina. 
     In examining the conditions of the cervix with the use of known vaginal specula, it is difficult to diagnose cervical papilomas at the initial stage of their development. This is because such initial papilomas are very small. A papiloma is a growth pattern of epithelial tumors. 
     BRIEF SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide a disposable vaginal speculum, which is simple in construction, easy to operate, inexpensive to manufacture, allows painless withdrawal of the speculum blades in an expanded state, has adjustable blades, provides means for measuring the length of the vagina, testing for and measuring the severity of the prolapse, provides optical magnification means for enlargement of the observed area, and gives allowance to concentrate the observation separately on each wall of the vagina. 
     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 vagina cavity. The device is characterized by having moveable blades, which can be withdrawn partially or completely from an axially-fixed main parts and for replacement with blades of other dimensions without withdrawing the entire speculum from the vagina. In a closed state, the distal ends of the blades form a bifocal lens, which can be used for visually detecting changes, associated with an earlier stage of cancer or erosion. 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. 
    
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
     FIG. 1 is a side sectional elevation view of the speculum of the invention. 
     FIG. 2 is a sectional view along line II—II in FIG.  1 . 
     FIG. 3 is a view of the vaginal speculum of FIG. 1, which shows the blades of the speculum in an open or expanded position. 
     FIG. 4 is a sectional view along line IV—IV in FIG.  3 . 
     FIG. 5 is a rear view of the vaginal speculum of the invention in the direction of arrow A in FIG.  1 . 
     FIG. 6 is a side sectional elevation view of the speculum according to another embodiment of the invention, in which both blades are adjustable. 
     FIG. 7 is a sectional view along line VII—VII in FIG.  6 . 
     FIG. 8 is a view in the direction of arrow B in FIG.  6 . 
     FIG. 9 is a view in the direction of arrow C in FIG.  6 . 
     FIG. 10 illustrates another embodiment of the speculum of the invention in which the handle portion is bent backward to form an obtuse angle with the longitudinal direction of the adjustable blades. 
     FIG. 11 shows another embodiment of the speculum of the invention in which the proximal ends of the adjustable blades are bent radially outward from the longitudinal axis of the adjustable blades. 
     FIGS. 12 and 13 are fragmental views in the direction of arrows D and E of FIG. 6, respectively. 
     FIG. 14 is a sectional view of normal reproductive organs of a woman. 
     FIG. 15 shows an example of cystocele inside the vaginal canal. 
     FIG. 16 shows a condition of a cystocele protruding outside the vagina. 
    
    
     SUMMARY 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 vagina cavity. The device is characterized by having adjustable blades, which can be withdrawn partially or completely for replacement with blades of other dimensions without withdrawing the entire speculum from the vagina. In a closed state, the distal ends of the blades form a bifocal lens, which can be used for visually detecting changes, associated with an earlier stage of cancer or erosion. 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. 
     DETAILED DESCRIPTION OF THE INVENTION 
     In general, a vaginal speculum of the present invention is similar to the one described in U.S. Pat. No. 3,716,047 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 of the invention, the speculum  20  comprises a fixed blade member  22 , a slide member  24 , and a movable blade member  26 . 
     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 of the blade portion  22   a , i.e., the end opposite to the handle portion  22   a , has a half-lens  25 , which is formed, e.g., molded, integrally with the remaining part of the blade portion  22   a . The half-lens  25 , in fact, is a portion of a biconvex lens obtained by cutting a lens by half along an optical axis X—X (FIG.  1 ). FIG. 3 is a view of the vaginal speculum  20  of the invention, which shows the blades of the speculum of FIG. 1 in an open or expanded position. 
     Ratchet teeth  30  are formed on the lower rear side of the handle portion  22   b  for the purposes explained later. As shown in FIG. 4, which is a sectional view along line IV—IV in FIG. 3, the part of the handle portion  22   a  located above the teeth  30  may have a slot  32  of a T-shaped cross-section for guiding a complementary shaped part of the slide member  24 , which also has a T-shaped cross-section. 
     The slide member  24  of the vaginal speculum  20  of the present invention has a fork-like straight portion  34 , 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. 5 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. 5, 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 proximal part 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&#39;s vagina and a trigger portion  26   b  formed on the proximal end 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. In other words, the blade portion  26  has a semicircular or oval cross-section shown in FIG.  2  and has a half-lens  48  with a flat surface  50  (FIG.  3 ). Thus, as shown in FIG. 1, in a closed state of the speculum, the blade portions  22  and  26  form a tubular body of a complete round or oval cross-section with a complete biconvex lens formed by two half-lenses  25  and  48  at the distal end of the speculum. 
     As shown in FIG. 2, in the embodiment shown in FIGS. 1 through 5, the movable blade member  26  has, on the inner side, guide edges  26   c  and  26   d , which are bent upward and form guide grooves  26   e  and  26   f . As shown in FIG. 1, guide edges  26   c  and  26   d , may be formed only on a short portion (L) of the entire length of the movable member  26 . The grooves  26   e  and  26   f  are used for slidingly guiding an adjustable blade  54  (FIGS. 1,  2 , and  3 ) of the moveable member  26 . In other words, moveable member  26 , in turn, consists of two parts, i.e., the main part  27  with the trigger portion  26   b  and the adjustable blade  54 , which contains the aforementioned insertable part  26   a . The adjustable blade  54  may have tight sliding fit in the grooves  26   e  and  26   f  r, so that it can be shifted in the rearward direction, i.e., in the direction opposite to the direction of arrow A in FIG. 1, to assume a position shown in FIG.  3 . For convenience of shifting, the adjustable blade  54  may have a tab  55  on its rear end. Thus, after the adjustable blade  54  has been shifted in the rearward direction, it will be held in the adjusted position by the aforementioned tight fit. Furthermore, as shown in FIG. 3, in this case the expansion diameter D 2  will be smaller than the expansion diameter D 1  for non-adjustable blade member  26  shown in FIG. 3 by the broken line  26 ′. 
     In order to prevent the adjustable blade  54  from sliding relative to moveable member  26  during insertion of the speculum into the patient&#39;s vagina, the proximal end of the adjustable blade  54  has a dent  54   a  on its outer surface, whereas the moveable portion  26  has an indent  26   h  on its inner surface for engagement with the dent  54   a . Normally the dent  54   a  is engaged with the indent  26   h  under the effect of resiliency of the adjustable blade  54 , so that during insertion of the distal end of the speculum  20  into the patient&#39;s vagina the adjustable blade will not slide relative the moveable portion. In addition, during insertion the tab  55  will bears up against the thumb of a physician who inserts the speculum. In order to adjust the position of the adjustable blade  54  and thus to move it relative to the moveable portion  26 , it is necessary to slightly push the proximal end of the adjustable blade  54  down in order to disengage the indent  26   h  from the dent  54   a  and then to move the adjustable blade  54   a  in a required direction. 
     As shown in FIG. 1, trigger portion  26   b  has an opening  26   g  with teeth  26   k  on the solid part of the trigger  26   b  for engagement with the teeth  38  on the projection  36  (FIG.  1 ). The teeth  26   k  and  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 shown in FIG.  3 . 
     The adjustable blade  54  can be completely removed and replaced by another blade having a different length. 
     If necessary, in addition to the movement of the adjustable blade  54  in the axial direction of the speculum  20 , another adjustment can be carried out by guiding the sliding member  24  in guide grooves  32  (FIG.  4 ), thus raising or lowering the pivot projections  43  and  45  together with the movable member  26  with respect to the fixed member  22 . This allows expanding the adjustment range. 
     FIG. 6 illustrates another embodiment of the vaginal speculum of the invention, in which both blades, i.e., a blade  56   a  of a movable member  56  and a blade  58   a  of a fixed member  58  are adjustable. The rest of the construction is the same as in the embodiment shown in FIGS. 1 through 5. As shown in FIG. 7, which is a sectional view along line VII—VII in FIG. 6, the fixed member  58  has on the inner side of the blade portion  58   a , guide edges  58   c  and  58   d , which are bent downward and form guide grooves  58   e  and  58   f . As shown in FIG. 6, guide edges  58   c  and  58   d , may be formed only on a short portion (L 1 ) of the entire length of the fixed member  58 . The grooves  58   e  and  58   f  are used for slidingly guiding the adjustable blade  58   a  (FIGS. 6) of the fixed member  58 . The speculum of FIG. 6 makes it possible to adjust the positions of both adjustable blades  56   a  and  58   a , so that along with the significant decrease in the diameter D 3  (FIG.  6 ), it becomes possible to ensure painless partial withdrawal of the of the blades in an expanded state for observation of the proximal part of the vagina. 
     In order to prevent the adjustable blade  5   8   a  from sliding relative to fixed member  58  during insertion of the speculum into the patient&#39;s vagina, the proximal end of the adjustable blade  58   a  has a dent  62   a  on its outer surface, whereas the fixed member  58  has an indent  58   b  on its inner surface for engagement with the dent  62   a.    
     The construction of the dent  56   b  and the indent  56   c  in the upper adjustable blade  56   a  and the moveable portion  56  are the same as in the moveable part  26  and in the adjustable blade  54  of the embodiment of FIG.  1 . 
     The vaginal speculum of the present invention is additionally provided with means for locating a position of a vaginal prolapse, of both cystocele-type and rectocele type. For locating a position of the aforementioned prolapses, both adjustable blades have on their proximal ends scales, e.g., in centimeters. FIGS. 8 and 9 are fragmental views in the direction of arrows B and C of FIG. 6, respectively. As can be seen from these drawings, the adjustable blade  56   a  has a scale  64  with divisions applied onto its outer surface and has the very end as a zero or a reference point with the number in centimeters or inches increased from this point to the proximal end. In other words, the scale  64  can be used as a conventional ruler. Similarly, a scale  68  has divisions applied onto the inner surface of the blade  58   a . The divisions should be made black so that they could be seen on the transparent background of the material of the adjustable blades  56   a  and  58   a . The lower scale also has its reference point at the outermost distal point of the adjustable blade  58   a.    
     FIG. 10 shows another embodiment of the speculum of the invention in which the handle portion  80  can be bent backward to form an obtuse angle α with the longitudinal direction of the adjustable blades  82  and  84  in order not to interfere with outwardly extending parts of the patient&#39;s body, such as buttocks, e.g. in overweight women. 
     FIG. 11 shows another embodiment of the speculum of the invention in which the proximal ends  86  and  88  of the adjustable blades  90  and  92  are bent radially outward from the longitudinal axis of the adjustable blades  90  and  92 . This is necessary in order not to obscure the vision through the central opening of the speculum when, during expansion of the distal ends of the blades  90  and  92 , their proximal ends  86  and  88  move radially inwardly toward each other. 
     FIGS. 12 and 13 are fragmental views in the direction of arrows D and E of FIG. 6, respectively. As can be seen from these drawings, the scale  64  on the movable or adjustable blade  56   a  may extend further to the protruding proximal end  60  of the adjustable blade  56   a , so that measurements can be read with regard to the rear edge  66  of the movable part  56 . The same principle can applied to the fixed member  58 , where divisions of the scale  68  can extend to the protruding proximal end  72  (FIG.  13 ), so that measurements can be read with regard to the rear edge  70  of the fixed member  58 . 
     Procedure for the use of the retractable vaginal speculum 
     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 retractable vaginal speculum of a required size is then chosen. 
     Since a retractable 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 5, the insertable ends  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. 14, which is a sectional view of normal reproductive organs of a woman. 
     The physician first visually observes the condition of the uterus cervix through the optical lens formed by semilenses  48  and  25 . The purpose of this observation is to detect initial changes on the cervix that could not be detected by a naked eye. Such changes may be initial erosion, papilomas, etc. 
     The speculum  20  is then opened by moving the blade members  22  and  26  apart to further visualize the vaginal vault or the cervix. This is done 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 in FIG.  3  and thus expand the vaginal cavity (not shown in the drawings). 
     The physician can then observe the appearance of the vaginal mucosa at the level of the vault, or observe the appearance of the cervix. If necessary, the length of the vaginal canal is measured from the vaginal vault or the posterior aspect of the cervico-vaginal junction to the level of the hymenal line. This is achieved by pushing down on the tab  55  of the adjustable blade  54  for disengaging the dent  54   a  from the indent  26   h  and by moving the adjustable blade  54  to a required position. Measurement is made by reading the numbers of the scale  64  with regard to the hymeneal line, as will be described later. As shown in FIGS. 8 and 9, where FIG. 8 is a view in the direction of arrow B, and FIG. 9 is a view in the direction of arrow C in FIG. 6, the divisions of the scale are applied onto the entire length of the blades  54  and  25  in the embodiment of FIG. 1, and of the blades  54   a  and  58   a  in the embodiment of FIG. 6, so that the physician could measure the distance from the hymeneal ring to the cervix, as well as the distance to the end of the prolapse using the very end of the distal end as the reference point for measurement. If necessary, the physician performs paps smear and/or collection of fluids for culture and or cytology as indicated. Slight thickening of the curved end walls on the distal ends of the blades  20  and  22  caused by the formation of semilenses does not create any obstacles for this operation. 
     For separate observation of the condition of one of the walls of the vagina, the adjustable blade, e.g. blade  54  (FIGS. 1 and 2) is then retracted halfway so that the blade of the speculum  20  (or speculum  56 ) is in a position required for the observation of the exposed wall. Since one of the blades, i.e., the blade  22  remain in the initial position (FIG. 3) and another blade, i.e.,  26 , is partially withdrawn, the physician may observe the condition of the exposed part of the vagina wall for observation and thus to see prolapses on the exposed wall. This would be unattainable for the conventional speculum without completely withdrawing the entire speculum, disassembling it, and using only one part as a spade for pressing on one wall of the vagina in order to expose the opposite wall for observation. In the case of the embodiment of FIG. 6, both adjustable blades  56   a  and  58   a  can be withdrawn in alternating sequence, or can be retracted both together to see if the uterus or the vaginal vault (dome) will drop further down. The degree of the drop of the uterus or the vaginal vault (dome)(if the uterus is gone) in relation to the hymeneal line can be measured with the calibrated retractable blade. This is easily done by positioning the tip of the sliding blade to the lowest edge of the prolapsing organ, i.e. cervix or vaginal vault or cystocele or rectocele and measuring from that distance to the level of the hymeneal line. 
     The aforementioned measuring procedure will be now explained with reference to FIGS. 14,  15 , and  16 ; wherein FIG. 12 shows a normal anatomy of female reproductive organs, FIG. 15 shows an example of cystocele inside the vaginal canal and method for measuring its position and dimensions, and FIG. 16 shows a condition of a cystocele protruding outside the vagina and a method for measuring the length of this cystocele. 
     As shown in FIG. 14, the distance L between the tip of the cervix  100  and the hymeneal ring is measured by inserting the speculum  102  in a closed state shown in FIG. 1 to contact with the dome of the uterus  100  and by reading the number on the scales of the blades at the hymeneal line  104 . The distance between these two points will be in centimeters and will be recorded as a minus number. For example, if the cervix is prolapsing (not shown) and the distance between the edge of the cervix inside the vaginal canal to the hymeneal ring is  3  centimeters, then the cervix prolapse is −3 cm. Likewise, if, as shown in FIG. 15, there is a cystocele  106  and it is prolapsing or dropping, the physician can retract the adjustable blade  54  (FIG.  3 ), or the adjustable blade  56   a  (FIG.  6 ), and then move it to contact of the distal tip of this adjustable blade with the edge of the systole. The distance L 1  between with the edge of the cystocele  106 , touching the tip of the retractable blade  106 , and the level of the hymeneal line  108  is then measured with regard to the hymeneal line  104  as a reference point. If L 1  is  4  centimeters, then the prolapsing cystocele is −4 cm. The same procedure can be performed with regard to rectocele (not shown) by moving the adjustable blade  58   a  (FIG.  6 ). 
     If the prolapse is so severe that, as shown in FIG. 16, 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 cystocele  110  is protruding out, then the measurement of the prolapse will be a distance L 2  from the hymeneal line  112  to the furthest tip of the prolapsing cystocele. This distance is measured by means of the scale on the tip  114  of the speculum  116  as by a conventional ruler. If the prolapse is dropping outside the hymeneal line; i.e. is 5 centimeters, the cystocele prolapse is +5 cm. 
     In accordance with an alternative method, the severity and positions of the prolapses can be measured by using rear edges  66  (FIG. 12) and  70  (FIG. 13) of respective proximal portions of the blades. In this case, the distance L 1  can be measured by reading the number on the scale  68  between the edge  70  of the cystocele  106  touching the tip of the retractable blade  106  and between the edge  70  and the hymeneal line  108 . The length L 1  will be determined by subtracting the second reading from the first one. The same is applicable for measuring rectocele (not shown).