Abstract:
A pair of lateral structures is removably attached to a vaginal speculum after the speculum is inserted and opened to retract anterior and posterior vaginal tissue. Each of the lateral structures includes a blade extending along a side of a space provided between the opposed blades of the vaginal speculum to retract lateral vaginal tissue.

Description:
BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   This invention relates to a vaginal speculum and, more particularly, to a vaginal speculum including means providing for retraction of the lateral walls of the vagina. 
   2. Summary of the Background Art 
   A vaginal speculum is an important medical tool for providing visual access to structures within the vaginal opening, including the cervix, during a gynecological examination. A conventional vaginal speculum includes a pair of opposed blades movable between a closed position, with the opposed blades lying against one another, and an open position, with the opposed blades spaced apart from one another. During a gynecological examination, the blades of the speculum are inserted into the vagina with the opposed blades in the closed position. Then opposed blades are then opened, allowing the vagina to be visualized through an opening in a frame disposed adjacent a proximal end of the blades. Typically, the speculum additionally includes latching or screw means to hold the movable blade in its open position, or in additional positions between its closed and fully open positions. 
   When the conventional speculum is thus inserted and opened, its blades press upon the anterior and posterior walls of the vagina. However, since the blades do not extend along the lateral walls of the vagina, in certain patients, these lateral walls collapse inward, blocking visual examination of the vagina and cervix as required during a gynecological examination. This problem is often encountered in patients who have had multiple vaginal deliveries of babies and in obese patients. The levator and musculature of a patient who has experienced multiple vaginal deliveries may be relaxed so that the lateral vaginal walls collapse inward during the examination, with the muscles having been mechanically overstressed from the multiple deliveries and from weight gain associated with multiple pregnancies. An obese patient may present a similar problem during examination due to excessive connective tissue beneath the pelvic peritoneum. One effect of this problem is that the clinician may extend the blades of the speculum farther than otherwise necessary in an attempt to pull sagging tissue into a stretched condition, resulting in additional patient discomfort. 
   This problem may be alleviated by providing the speculum with an elastic sheet or membrane extending between the blades in their open position to hold the lateral vaginal wall tissue in place. For example, International Application WO 98/33431 describes the use of a sleeve of elastic material, placed over the blades or jaws of the speculum to stretch when the jaws are opened so that sleeve portions span openings between the jaws, preventing the prolapse of tissue into these openings. The sleeve can be supplied in a rolled condition for ease of application, and may have a bead at one end to assist in its removal from the speculum jaws. Alternately, as described in U.S. Pat. No. 6,432,048, loose vaginal tissue may be retained in a lateral direction by a speculum including a flexible membrane structure, such as a pair of membranes that extend between the blades. The membranes are configured to remain in a generally collapsed configuration when the blades are in the closed position to avoid interfering with insertion or withdrawal of the speculum. What is needed is a speculum having rigid surfaces for holding the prolapsed lateral tissue in place, since such surfaces do not rely on the forces necessary to stretch membranes or elastic materials sufficiently for such purposes. 
   Alternately, lateral vaginal sidewall tissue may be held in place with a device that expands laterally, such as the vaginal speculum described in U.S. Pat. No. 4,994,070, which has a sheet member of inherently resistant material capable of being rolled into a normal position in which the member forms a narrow, generally elongate shape. The sheet member is expandable under its inherent resilience to a dilated position in which the member forms a hollow generally open ended shape having a substantially continuous sidewall. The sheet member is provided with first and second handle members that are attached to the sheet member along left and right edges, respectively. Again, what is needed is a speculum having rigid surfaces for holding the prolapsed tissue in place, since such rigid surfaces can be shaped optimally for this purpose. 
   As described in U.S. Pat. No. 6,527,710, the lateral walls of the vagina may alternately be supported by a number of rounded ribs, extending parallel to one another between a stationary blade and a link fashioned as a moving blade of a speculum. Each of the ribs is pivotally attached at one end to the stationary blade and at the other end to the link. When the speculum is closed, the ribs and the link lie against the stationary blade. As the speculum is opened, the ribs pivot away from the surface of the stationary blade with the link. What is needed is a speculum having rigid surfaces for holding the prolapsed tissue in place without multiple twisting movements, which may cause patient discomfort. 
   U.S. Pat. Nos. 5,509,893 and 6,436,033 describe vaginal specula having four blades, comprising two pairs of blades that open in directions perpendicular to one another. While two of these blades would support sagging lateral vaginal tissue, the closed state of the speculum presents a cylindrical blade structure. What is needed is a speculum having insertable lateral blades, so that the speculum can be inserted into the vagina in a flattened condition, presenting a minimum cross sectional area for ease of insertion and minimum patient discomfort. 
   U.S. Pat. No. 6,569,091 describes a vaginal speculum consisting of two pivotally interconnected and disconnectable jaws, each of which supports a blade assembly movable in a longitudinal direction. Additionally, one of the blades can be moved circumferentially. Each blade can be completely withdrawn from the speculum, even during the procedure. 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. However, to permit such circumferential movement, both the blade and the jaw on which it is mounted are arcuate in shape, with the jaws being shown as coming together to form a cylinder split into halves along its axis. What is needed is a speculum including connectable blades for retaining prolapsed tissue without placing such requirements on the shape of the speculum in it closed condition, in which it is inserted into the vagina. 
   SUMMARY OF THE INVENTION 
   According to a first aspect of the invention, apparatus is provided for retracting wall surfaces within a vagina during examination with a speculum having opposed blades opened for retracting tissue from anterior and posterior wall surfaces of the vagina and a frame having an opening through which internal structures are visualized. The apparatus includes a first lateral structure having a first handle portion and a first lateral blade. The first handle portion includes a downwardly open slot for removably attaching the first lateral structure to a first side of the frame of the speculum. The first lateral blade extends downward from the first handle portion, laterally adjacent a space between the opened opposed blades of the speculum, with the first side of the frame engaged within the downwardly open slot of the first handle portion. 
   The apparatus preferably additionally includes a second lateral structure having a second handle portion and a second lateral blade. The second handle portion includes a downwardly open slot for removably attaching the second lateral structure to a second side of the frame of the speculum. The second lateral blade extends downward from the second handle portion, laterally adjacent a space between the opened opposed blades of the speculum, with the second side of the frame engaged within the downwardly open slot of the second handle portion. 
   According to another aspect of the invention, a method is provided for performing a vaginal examination. The method includes: inserting an opposed pair of blades of a speculum into a vaginal opening with the opposed blades lying against one another; opening the opposed pair of blades to expose internal structures within the vaginal opening through a space between the opposed pair of blades; after opening the opposed pair of blades, inserting a first lateral blade within the vaginal opening to extend along a first side of the space between the opposed pair of blades; attaching a handle portion disposed at a proximal end of the first lateral blade to a first side of an open frame of the speculum, extending adjacent a proximal end of the space between the opposed pair of blades; removing the handle portion of the first lateral structure from the frame of the speculum; withdrawing the first lateral blade from the vaginal opening; closing the opposed pair of blades within the vaginal opening to lie against one another; and removing the opposed pair of blades from the vaginal opening. 

   
     BRIEF DESCRIPTION OF THE FIGURES 
       FIG. 1  is a left elevation of a speculum built in accordance with the invention; 
       FIG. 2  is a plan view of the speculum of  FIG. 1 ; 
       FIG. 3  is a cross-sectional view of the speculum of  FIG. 1 , taken as indicated by section lines  3 — 3  therein; and 
       FIG. 4  is a cross-sectional view of an alternative version of a speculum built in accordance with the invention, taken as the cross-sectional view of  FIG. 3 . 
   

   DETAILED DESCRIPTION OF THE INVENTION 
     FIG. 1  is a left elevation of a speculum  10  built in accordance with the invention to include a pair of detachable lateral sections  12  for holding prolapsed vaginal tissue in place after the speculum  10  is inserted and opened. Various other aspects of the speculum  10  may be conventional. For example, the speculum  10  includes a handle  14 , a stationary blade  16  attached to descend from the handle  14 , and a movable blade  18  attached to a lever  20 , being slidably and pivotally attached to the handle. The movable blade  18  and lever  20  are shown in solid lines with the speculum fully open and in dashed lines  22  with the speculum fully closed. In the fully closed position, the movable blade  18  lies against the stationary blade  16 , presenting a minimally sized structure for insertion into the vagina. Thus, the stationary blade  16  and the movable blade  18  together form a pair of opposed blades  16 ,  18 , movable between a closed position and an open position. 
     FIG. 2  is a plan view of the speculum  10 , shown in a fully open position with the lateral sections  12  attached thereto. The movable blade  18  is seen to be attached to the lever  20  by means of a frame  24 , extending from a proximal end  25  of the movable blade  18  upwardly adjacent a proximal end  26  of the stationary blade  16 . The frame  24  includes an opening  27  through which the structure of the vagina and cervix are visualized with the blades  16 ,  18  inserted and separated by opening. 
   The movable blade  18  is pivotally attached to the lever  20  by means of a pair of pins  28  extending outward within slots  30  in the frame  24 . The slots  30  include a stepped surface  32  providing several locations at which the movable blade  18  may be pivoted on the handle  14 . The angle of attachment between the movable blade  18  and the handle  14  is further determined by a slotted tabs  34  extending downward, in the direction of arrow  36 , from opposite sides of a slot  38  within the lever  20 . When the lever  20  is slid fully in the direction of arrow  40  to close the speculum  10 , the slotted tabs  34  can be freely moved within an enlarged opening  40  within the handle  14 . As the lever  20  is slid opposite the direction of arrow  20  to open the speculum  10 , the sides of a narrowed slot  42  within the handle engage slots  44  within the slotted tabs  34 , preventing rotation of the lever  20  about the pins  28  while permitting sliding movement. 
     FIG. 3  is a cross-sectional view of the speculum  10 , taken as indicated by section lines  3 — 3  in  FIG. 1 , to particularly show how the lateral sections  12  are removably attached to the frame  24 . Each of the lateral sections  12  includes a curved handle portion  46  having a downwardly open J-shaped slot  48  fitting over a straight lateral portion  50  of the frame  24  and additionally extending inwardly over part of a curved end portion  51  of the frame  24 . Each of the lateral sections  12  also includes a lateral blade portion  52  extending downward outwardly adjacent a space  54  between the stationary blade  16  and the moving blade  18  with the speculum  10  fully open. Thus, each of the curved handle portions  46  is disposed at a proximal end  55  of the associated lateral blade portion  52 . 
   According to one version of the invention, the stationary blade  16  and the movable blade  18  are first inserted into the vagina with the speculum  10  in the closed position, so that these blades  16 ,  18  are held together as indicated by the dashed lines  22 , presenting a minimum cross-section for easiest insertion, and with the lateral sections  12  disconnected from the speculum  10 . Then, the lever  20  is pivoted in the direction of arrow  56 , being moved into place against the handle portion  14 . Next, the lever  20  is slid opposite the direction of arrow  40 , bringing the movable blade  18  into the fully open position indicated by dashed lines  22 . Next, the curved blade portion  52  of each of the lateral sections  12  is individually inserted into the vagina, being held by the corresponding handle portion  46 , and being manipulated to push sagging tissue from a corresponding lateral vaginal wall outward. This insertion movement moves the downwardly open J-shaped slot  48  within each of the handle portions  46  into engagement with a corresponding portion  50  of the frame  24 , with this engagement subsequently holding the lateral section  12  in place. 
   When the lateral sections  12  have been installed in this way, each of the lateral sections  12  extends downward through the opening  27 . Since the opening  12  diminishes as the speculum  10  is closed, with the opening  12  moving in the direction of arrow  40  into place mostly over the curved upper portion  56  of the stationary blade  16 , it is necessary to remove the lateral sections  12  before the speculum  10  is fully closed. Thus, after the examination has been completed, the lateral sections  12  are disengaged from the frame  24  and removed from the speculum  10  and from the vagina. Then, the speculum is closed and withdrawn from the vagina. 
     FIG. 4  is a cross-sectional view of an alternative version  60  of a speculum built in accordance with the invention, including a pair of lateral sections  62  extending downward outside the frame  24  instead of inside the opening  27  within the frame  24 . The cross-section of  FIG. 4  is taken in the manner of the cross-section of  FIG. 3 . The lateral sections  62  are additionally shown as being held in place by a pair of clamping screws  64 . Other aspects of the alternative version  60  are as explained above for the speculum  10  in  FIGS. 1–3 , with like reference numbers being accorded. 
   While the alternative version  60  is preferably inserted within the vagina as described above, the lateral sections  62  need not be removed before the alternative version  60  is closed. Thus, the lateral sections  62  can be removed separately after the alternative version  60  is closed. This version of the process of using the alternative version  60  has the advantage of preventing the pinching of sagging lateral vaginal tissue between the stationary blade  16  and the moving blade, thereby eliminating a potential cause for patient discomfort. However, the version of  FIG. 3  has an advantage of relatively easy insertion of the curved blade portions  52  within the vagina. 
   While both the specula  10 ,  60  are shown generally as being composed of an opaque thermoplastic resin, it is understood that the such devices, and portions thereof, such as the lateral sections  12 ,  62  can readily be composed of transparent thermoplastic materials to aid in the visualization of certain areas. It is further understood that such devices and portions thereof may be composed of metal for greater strength and stiffness. Metal versions of specula, to which lateral sections may be applied in the manner of the invention, are known to have clamping screws providing for fine adjustments in the sliding and pivoting motions of the movable blade relative to the handle and stationary blade. The thumbscrews  64  may be optionally applied to the version of the lateral sections  12  otherwise shown in  FIG. 3 . 
   The lateral sections  12 ,  62  may be packaged and sold separately from the remaining portions of a speculum, or these parts may be packaged and sold together. Two or more variations of lateral sections  12 ,  62  may be sold for use with a single version of a speculum, with the different versions of the lateral sections  12 ,  64  being optimized for use at different degrees in which the speculum is opened for different procedures and different patients. 
   While the invention has been described and shown in its preferred versions or embodiments, it is understood that this description has been given only by way of example, and that many variations in the arrangement of parts may be made without departing from the spirit and scope of the invention, as described in the appended claims.