Abstract:
A vaginal speculum consists of two pivotally interconnected disconnectable parts. Each part slidingly supports a movable blade moveable in the longitudinal direction of the speculum. In addition to longitudinal movement, one of the blades can be moved circumferentially. Each blade can be completely withdrawn from the speculum, even during the procedure, i.e., without removing the speculum from the vagina. As a result, the same speculum can be used in procedures requiring both as well as only one blade. Furthermore, the entire upper part of the speculum, i.e., the guide portion together with the removable blade, can be completely disconnected from the speculum without removing the latter from the vagina. The remaining lower part can be used as a spatula. Circumferential displacement of one of the blades in both directions makes it possible to observe the vaginal cavity over the entire periphery without rotating the entire speculum or replacing it with another tool.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     The present patent application is continuation of our previous U.S. patent application Ser. No. 09/565,613 filed on May 4, 2000, which is now pending. 
    
    
     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. 
     BACKGROUND OF THE INVENTION 
     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. 
     DESCRIPTION OF THE PRIOR ART 
     One typical vaginal speculum is described in U.S. Pat. No. 3,716,047 issued in 1973 to W. C. Moore et al. 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. In the context of the present invention, the term “distal” is used with regard to the end of the speculum remote from the user&#39;s hand, while the end on the side of the part 26 is referred to as a proximal end of the speculum. 
     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 them from the vagina and reinserting other tools one at a time. Such multiple maneuvers are not only very inconvenient and time-consuming but also irritating and uncomfortable to the patient. 
     Furthermore, the speculum of U.S. Pat. No. 3,716,047 does not allow for observation of the entire periphery of the vaginal cavity without rotating the speculum as a whole, which is undesired and inconvenient. 
     An attempt to solve a problem associated with possibility of observing the entire periphery of the vaginal cavity is described in U.S. Pat. No. 6,048,308 issued in 2000 to John Strong. The speculum described in this patent is provided with two additional blades insertable into the speculum housing for spreading apart in lateral direction required for observation of the side walls of the vaginal cavity. A disadvantage of this device is that it requires the use of two additional blades. These blades cannot be disconnected from the speculum without removing the latter from the vaginal cavity. 
     An attempt to solve the problems regarding adjustability of the blades in a longitudinal direction is partially solved in a vaginal speculum described in U.S. Pat. No. 2,579,849 issued in 1951 to Louis Newman. The speculum described in the above patent has blades adjustable in the longitudinal direction by extending their distal ends. The adjustable blades are guided in pivotally interconnected parts and cannot be completely removed from the speculum but can only be shifted forward to increase the blades&#39; length. Since during the procedure the step formed at the point of protrusion of the adjustable portion from the guiding portion is located inside the vagina, there is a danger of pinching a mucosa during withdrawal of the adjustable blade towards the guide portion. The speculum of U.S. Pat. No. 2,579,849 does not allow for observing side walls of the vaginal cavity without completely removing it from the vagina and replacing with another instrument. 
     Furthermore, in examining the conditions of the cervix with the use of the aforementioned 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. 
     U.S. Pat. No. 2,579,849 issued to L. B. Newman in 1951 describes a vaginal speculum with adjustable blades which during the procedure are completely insertable into the vagina and only small distal tips thereof are adjusted inside the vagina. In other words, the adjustable blades of Newman are first inserted into the vagina and then could be adjusted in length by moving forward the distal ends of the blades. The Newman device is first inserted into the vagina only with its constant length and then can be slightly extended forward within the vagina. It can be seen from FIG. 3 of Newman&#39;s patent that the guide portions for the adjustable tips of Newman are completely inserted into the vagina and thus constitute the blades themselves. 
     The applicants made an attempt to solve the problems of the prior art by developing a vaginal speculum described in U.S. patent application Ser. No. 09/565,613 filed on May 4, 2000, now pending. The vaginal speculum described in the aforementioned patent application consists of two parts pivotally interconnected through a fork-like member. Each part slidingly supports a blade moveable in the longitudinal direction of the speculum so that each blade can be shifted to a required position and fixed in this position for further use. The removeable blades 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. The blades are provided with a scale for measuring the positions and dimensions of the prolapses. 
     In spite of all the advantages, the vaginal speculum of U.S. patent application Ser. No. 09/565,613 still has some drawback. Though the removeable blades can be shifted to any required position and even completely removed or replaced, the pivotally connected parts that guide the blades are not disconnectable. In some cases, however, a procedure may require that the physician must use only one blade. To accomplish this task with any known vaginal speculum, including the one described in the last-mentioned patent application, the physician has to withdraw the entire speculum from the vagina and replace it with a single-blade instrument. Another disadvantage of the non-disconnectable speculum is that it is inconvenient for cleaning, storage, and packing. Furthermore, the blades can be moved only linearly in a longitudinal direction of the speculum and cannot be moved circumferentially for observation of side walls of the vaginal cavity without replacing, removing or rotating the entire speculum. 
     OBJECTS OF THE INVENTION 
     It is an object of the present invention to provide a vaginal speculum, in which one of the blade guide parts can be disconnected or the blade can be removed from the speculum without interrupting the procedure. Another object is to provide a vaginal speculum which is convenient for cleaning, storage and packing and which allows observation of the vaginal walls over the entire perimeter of the vaginal cavity without withdrawing, replacing or rotating the entire speculum. Another object is to provide a vaginal speculum having blades moveable in axial as well as in circumferential direction. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1A is a side sectional elevation view of the vaginal speculum of the invention. 
     FIG. 1B is a sectional view along line IB—IB of FIG.  1 A. 
     FIG. 1C is a sectional view along line IC—IC of FIG.  1 A. 
     FIG. 2 is a partial side view of the speculum of FIG. 1A illustrating disassembling of main parts. 
     FIG. 3 is a top view on a part of the vaginal speculum of FIG. 1A with the upper blade removed. 
     FIG. 4 is a top view on one of the removeable blades of the speculum of FIG.  1 A. 
     FIG. 5 is a side view of a blade of FIG.  4 . 
     FIG. 6 is a view similar to the one of FIG. 3 with the upper blade inserted. 
     FIG. 7 is a sectional view along line VII—VII of FIG.  6 . 
     FIG. 8 is a view similar to the one of FIG. 6 with the upper blade turned circumferentially from the position shown in FIG.  6 . 
     FIG. 9 is a sectional view along line IX—IX of FIG.  8 . 
    
    
     SUMMARY OF THE INVENTION 
     A vaginal speculum consisting of two pivotally interconnected disconnectable parts. Each part slidingly supports a blade moveable in the longitudinal direction of the speculum. In addition to longitudinal movement, one of the blades can be moved circumferentially. Each blade can be completely withdrawn from the speculum, even during the procedure, i.e., without removing the speculum from the vagina. As a result, the same speculum can be used in procedures requiring both as well as only one blade. Circumferential displacement of one of the blades in both directions makes it possible to observe the vaginal cavity over the entire periphery without rotating the entire speculum or replacing it with another tool. 
     DETAILED DESCRIPTION OF THE INVENTION 
     In general, a vaginal speculum of the present invention is similar to the one described in our U.S. patent application No. 09/565,613 and is aimed at its improvement. Therefore some small details of the vaginal speculum of the present invention identical to those in the speculum of the previous patent application will be omitted from the description. 
     As can be seen from FIG. 1A, which is a side elevation view of the speculum  20  of the invention, the speculum  20  consists of three main parts: a first part  22  (hereinafter referred to as an upper part), a second part  24  (hereinafter referred to as a lower part), and a third part  26 , hereinafter referred to as a sliding part, which can slide in guides  28  formed on the rear side of the lower part  24  in a transverse direction shown by the arrow A with respect to the longitudinal direction of the vaginal speculum shown by the arrow B. The sliding part  26  has pins  30  and  32  (only one of which, i.e., a pin  30 , is shown in FIG.  1 A), which pivotally supports the upper part  22 . 
     The upper part  22  has an L-shaped configuration with legs  34  and  36 . The leg  34  extends in the direction of aforementioned arrow B, and the leg  36  extends downward substantially perpendicular to the leg  34 . The leg  36  extends substantially in a downward transverse direction from the rear side of the leg  34  and is used for pushing on the upper part  22  when it is necessary to expand the speculum  20  inside the patient&#39;s vagina. The horizontal leg  34  of the upper part  22  has longitudinal guides  38  for an upper removable blade  40 . 
     The lower part  24  also has an L-shaped configuration with a horizontal leg  42  and a downward vertical leg or handle portion  44 . The leg  42  extends in the direction of aforementioned arrow B. The leg  42  has longitudinal guides  46  for a lower removable blade  48  that can move in the aforementioned guides  46  in the direction of arrow B. The aforementioned guides  28  for the sliding part  26  are located on the rear end face of the handle  44 . 
     The sliding part  26  has a rearward projection  52 , which is substantially perpendicular to the fork-like straight portion  54  and has teeth  56  on one of its sides. The teeth  56  engage a pawl  57  formed on the surface of the slot (not shown) formed in the leg  36 . The sliding part  26  also has a tail portion  58  with a pawl  60  for engagement with ratchet teeth  62  formed in the lower rear side of the straight portion  54 . 
     As can be seen from FIG. 1B, which is a cross-sectional view along line IB—IB of FIG. 1A, the removable blades  40  and  48  have semicircular cross sections so that in a closed state of the speculum shown FIG. 1, both removable blades form a hollow tubular body having a complete round cross-section. 
     Furthermore, as can be seen from FIG. 1C, which is a cross-sectional view along line IC—IC of FIG. 1A, the aforementioned horizontal leg portions  34  and  42  also have semicircular cross-sections. It is shown in the same FIG. 1C that the aforementioned guides  38  and  46  are formed by radial outward grooves in the inner surface at the edges of the guide  38  and by radial outward grooves in the inner surface at the mating edges of the guide  42 . On the other hand, the removable blades  40  and  48  have radial outward projections on the mating edges, i.e., projections  40   a ,  40   b  on the blade  40  and projections  48   a ,  48   b  on the blade  48 . The projections  40   a ,  40   b ,  48   a ,  48   b  are rounded so that the outer surfaces of the blades remain smooth. 
     In order to provide rotation of the upper removable blade  40  by guiding in circumferential grooves described below, the guides  38  are formed on a part of length of the upper part  34 , so that for rotation the blade  40  should be first moved forward away from the proximal part until the projections  40   a  and  40   b  are freed from the guides  38  and then the blade  40  can be easily rotated. 
     The proximal ends  40   c  and  48   c  of respective removable blades  40  and  48  are bent outward in the upper and lower directions, respectively, to form parts convenient for pushing on the respective blades  40  and  48  to move them forward or for pulling them away when it is required to withdraw or replace the respective blade. 
     A distinguishing feature of the vaginal speculum  20  of the present invention consists in that the entire speculum  20  can be disassembled, i. e., all three main parts, i.e., the upper part  22 , the lower part  24 , the sliding part  26 , as well as the upper removable blade  40  and the lower removable blade  48  are disconnectable. More specifically, as shown in FIG.  1 A and FIG. 2, which is a partial side view of the speculum of FIG. 1A with the lower part  24  disconnected from the upper part  22 , the upper end of the fork-like sliding part  26  has hook-like shape with bayonet slots  64 ,  66  (the slot  66  is formed on the side of the fork-like part which is not seen in FIG.  2 ). The slots  64  and  66  serve for insertion of the pins  30  and  32 . The pin  32  is seen in FIG. 3 which is a top view on a part of the vaginal speculum  20  of FIG. 1A with the upper removable blade  40  and the sliding part  26  removed. Arrows C in FIG. 2 show directions of assembling disassembling of parts  22  and  24 . 
     Another unique feature of the vaginal speculum of the present invention consists in that in addition to movements in the axial direction shown by arrow B, at least one of the blades, e.g., the upper removable blade  40 , can be turned circumferentially around the longitudinal axis coinciding with the of arrow B (FIG. 1A) of the speculum  20 . This is achieved by forming a longitudinal slot and at least one circumferential slot in the upper surface in the rear side of the upper part  22  of the speculum (FIG.  3 ). Three such circumferential slots  70   a ,  70   b , and  70   c , which intersect the longitudinal slot  68 , are formed in the embodiment shown in FIG.  3 . The upper removable blade  40  has a vertical guide pin  72  shown in FIG. 4 which is a top view on one of the removable blades of the speculum of FIG.  1 A. FIG. 5 is a side view of a blade of FIG.  4 . FIG. 6 is a view similar to the one of FIG. 3 with the upper blade inserted. The pin  72  can be guided in the longitudinal slot  68  and in the circumferential slots  70   a ,  70   b , and  70   c , so that guiding in the longitudinal slot  68  defines axial movements of the upper blade  40  while guiding of the pin  72  in the circumferential slots  70   a ,  70   b , and  70   c  defines rotation of the upper blade  40  around the longitudinal axis. Position of the pin  72  in the longitudinal slot  68  is shown in FIG. 7, which is a sectional view along line VII—VII of FIG.  6 . FIG. 8 is a view similar to the one of FIG. 6 with the upper blade turned circumferentially from the position shown in FIG. 6 by guiding the pin  72  in the circumferential slot  70   a , and FIG. 9 is a sectional view along line IX—IX of FIG.  8 . Only upper guide part  22  and the upper removable blade  40  are shown in FIGS. 7 and 9. 
     Similar to the vaginal speculum of U.S. patent application Ser. No. 09/565,613, the speculum  20  of the present invention can be provided with a scale  74  formed on the upper removable blade  40  (FIG.  6 ). Similarly, the scale (not shown) can be formed on the lower blade  48 . The scales can be used for measuring the positions and dimensions of the vaginal prolapses. 
     As shown in FIG. 1A, similar to the vaginal speculum of U.S. patent application Ser. No. 09/565,613, in the speculum of the present invention the distal end of the upper removable blade  40  has a half-lens  76 , which is formed, e.g., molded, integrally with the remaining part of the blade  40 . The half-lens  76 , in fact, is a portion of a biconvex lens obtained by cutting a lens by half along an optical axis, which in this case coincides with longitudinal axis of the speculum. A similar half-lens  78  is formed at the distal end of the lower removable blade  48 . As a result, in a closed state of the speculum  20 , the blades  40  and  48  form a tubular body of a complete round or oval cross-section with a complete biconvex lens formed by two half-lenses  76  and  78  at the distal end of the speculum. 
     The vaginal speculum of the present invention is used in a manner described below. 
     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 vaginal speculum  20  of the invention having a required size is then chosen. 
     Since this vaginal speculum  20  is normally a disposable instrument, which is sterilized and packed into a sealed package in the form of the upper part  22 , a lower part  24 , a sliding part  26 , and removable blades  40  and  48 , it is unpacked and removed from the package and is assembled from the aforementioned disconnectable part. More specifically, the sliding part  26  is inserted into the guides  28  formed on he rear side of the handle portion  44  of the lower part  24  of the speculum and is fixed on it be engaging the pawl  60  with the ratchet teeth  62 . The upper part  22  is then pivotally connected to the sliding portion  26  by inserting pins  30  and  32  (FIGS. 2 and 3) into the slots  64 ,  66 . The removable blades  40  and  48  are inserted into their respective guides  38  and  46  (FIGS. 1A and 1C) and fixed in a required position with the use of dimples on the inner surface of the upper part and of a projection (not shown) on the outer surface in the proximal part of the removable blade  40 . 
     The speculum  20  is closed so that the blades  40  and  48  assume positions shown in FIG. 1C by solid lines. This is achieved by pushing the leg  36  in a counterclockwise direction around the pins  30  and  36  as fulcrum points. The removable blades are then lubricated using a water-soluble lubricant and gently inserted into the vaginal canal in the aforementioned closed state of the speculum. The blades  40  and  48  are advanced all the way to the vaginal vault or at the level of the uterine cervix (not shown). 
     The physician first visually observes the condition of the uterus cervix through the optical lens formed by semilenses  76  and  78 . 
     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 blades  40  and  48  apart to further visualize the vaginal vault or the cervix. This is done by pushing on the trigger portion  36  to turn it in a clockwise direction around pins  30  and  32  so that the pawl  57  slides in a ratchet manner over the teeth  56  of the leg  36 . As a result, the blade members  40  and  48  of the speculum  20  assume the positions shown in FIG. 1A by broken lines 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  40   c  of the removable blade  40  for disengaging the dent from the respective indent (not shown) and by moving the blade  40  to a required position. Measurement is made by reading the numbers of the scale  74  with regard to the hymeneal line, as is described in our previous U.S. patent application Ser. No. 09/565,613. The speculum of the present invention can be provided with the same measurement system as the speculum of our aforementioned patent application and allows all the measurements described in detail in that application. As the measurement system and method are beyond the scope of the present patent application, their description is omitted. 
     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 removable blade, e.g. blade  40  (FIGS. 1 and 5) is then retracted halfway so that only the blade  48  of the speculum  20  remains in the initial position. Since another blade  40  is partially withdrawn (these positions are not shown in the drawings), the physician may observe the condition of the exposed part of the vagina wall 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. If necessary, both removable blades  40  and  48  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. 
     Some procedures may required that the physician must use only one blade. To accomplish this task, the physician may completely disconnect the entire upper part  22 , from the lower part  24  sliding portion  26  by disengaging the projections  30  and  32  from respective slots  64  and  66  of the hook-like projection on the upper end of the fork-like sliding part  26 . The upper part  22  can be disconnected from the speculum without removing the latter from the vagina or when the speculum is removed from the vagina. 
     When it is necessary to observe the vagina wall covered with the blade, then, without removing the speculum  20  from and without rotating it inside the vaginal cavity, the physician will slide the pin  72  along the longitudinal slot  68  to a position of a require circumferential slot, e.g., the slot  70   a  (FIG. 8) and is then turned in the circumferential slot  70   a  to a lateral position (FIGS. 8 and 9) for exposing the area of interest. 
     All manipulations described above, i.e., partial or complete withdrawal of the removable blades  40 ,  48 , dilation of the vaginal cavity, complete disconnection of one of the guide parts of the speculum, etc., can be fulfilled without removing the speculum from the vaginal cavity. 
     If the speculum is intended for multiple use, complete disconnection of its parts facilitates its cleaning and storage. 
     Thus it has been shown that the vaginal speculum of the present invention allows complete disconnection of one of the blade guide parts or removal of the removable blade from the speculum without interrupting the procedure. The proposed vaginal speculum is convenient for cleaning, storage and packing and allows observation of the vaginal walls over the entire perimeter of the vaginal cavity without withdrawing, replacing or rotating the entire speculum. The vaginal speculum has blades moveable in axial as well as in circumferential direction. 
     Although the vaginal speculum of invention has been described in detail with reference to specific embodiments and drawings, it is understood that these embodiments do not limit the field of application of the invention and that any changes and modifications are possible, provided they do not go beyond the scope of the patent claims. For example, the hook and pin connection can be different from the one shown in the drawings and may be fulfilled, e.g., as a pin and sleeve connection with a sliding fit. The number of circumferential groove can vary from 1 to several. Both guide portions or only one of them may have replaceable removable blades.