Patent Publication Number: US-11659985-B2

Title: Universal vaginal speculum

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 16/795,643, filed Feb. 20, 2020, which claims priority to U.S. Provisional Patent Application No. 62/936,738, filed Nov. 18, 2019, and is a continuation-in-part of U.S. patent application Ser. No. 16/395,756, filed Apr. 26, 2019, now U.S. Pat. No. 11,147,445, each of which are incorporated herein by reference in their entireties. 
    
    
     BACKGROUND 
     Surgical vaginal speculums are self-retaining retractors used to obtain exposure to the vaginal canal to permit vaginal surgery. The existing speculums are composed of a blade that is inserted into the vaginal canal and a stem or handle which may or may not incorporate a weight to cause depression of the posterior vaginal wall to create space. The length of the blade for each speculum is fixed for which reason the operating room has to have an array of speculums of different sizes to adjust for the depth of the vagina and, in some cases, none of the array is properly sized for patient&#39;s vagina. Furthermore, the existing speculums have a fixed angle between the blade and the stem and, therefore, they are not always a proper fit corresponding to the pitch of the vagina, which depends on the pliability of the posterior wall. This can affect the degree of exposure created by the speculum. Because the pitch of the vagina depends on the pliability of the posterior vaginal wall, the angled speculums, which are meant to be self-retaining, cannot be properly inserted in those cases where the vaginal canal has little or no pliability. In this case, a 90 degree angle speculum is used which requires an assistant to apply downward pressure on the blade since these speculums do not incorporate a weight. And with the existing specula, there is no possibility of rotating the blade to allow for exposure of different parts of the vagina. 
     SUMMARY 
     The device and method presented addresses these deficiencies of the current vaginal speculums. As shown on  FIGS.  1  and  12    the disclosed universal vaginal speculum includes a fixed blade ( 2 ) and a movable blade ( 1 ). The movable blade ( 1 ) can be extended or retracted as required in order to adjust to the length of the vaginal canal of the patient undergoing surgery. The disclosed vaginal speculum also includes a mechanism to allow the height of the blades above the base to be adjusted. The disclosed vaginal speculum further includes various features and embodiments including a blade angle mechanism and a blade pivoting mechanism, which allows and controls the angle and rotation of the blades in relation to its base. A vacuum connection and a light features are also disclosed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1   . Shows an isometric view of an exemplary Universal Speculum wherein the blade is extended and at the top most position on the columns. 
         FIG.  2   . Shows a close-up isometric view of an exemplary Universal Speculum wherein the blade is extended and the ratchet back side in view. 
         FIG.  3   . Shows a close-up isometric view of an exemplary Universal Speculum wherein the blade is extended, the ratchet back side in view, and the blade assembly is pivoted. 
         FIG.  4   . Shows a close-up front view of an exemplary Universal Speculum wherein the blade is at the top most position on the columns and the blade assembly is pivoted. 
         FIG.  5   . Shows an isometric view of an exemplary Universal Speculum looking from the bottom up wherein the blade is extended and at the top most position on the columns indicating the rotational angel of the blade motion. 
         FIG.  6   . Shows a side view of an exemplary Universal Speculum wherein the blade is extended and at the top most position on the columns. 
         FIG.  7   . Shows a side view of an exemplary Universal Speculum wherein the blade is extended, on an angle, and at the top most position on the columns. 
         FIG.  8   . Shows a side view of an exemplary Universal Speculum wherein the blade is extended and at the bottom most position on the columns. 
         FIG.  9   . Shows a side view of an exemplary Universal Speculum wherein the blade is retracted, on an angle, and at the bottom most position on the columns. 
         FIG.  10   . Shows an exploded view of an exemplary Universal Speculum indicating the four main components. 
         FIG.  11   . Shows a front view of an exemplary Universal Speculum wherein the blade is at the top most position on the columns. 
         FIG.  12   . Shows an isometric view of another embodiment of an exemplary Universal Speculum wherein the blade is extended and at the top most position on the column. 
         FIG.  13   . Shows a close-up isometric view of another embodiment of an exemplary Universal Speculum wherein the blade is extended and the ratchet back side in view. 
         FIG.  14   . Shows a close-up isometric view of another embodiment of an exemplary Universal Speculum wherein the blade is extended, the ratchet back side in view, and the blade assembly is pivoted. 
         FIG.  15   . Shows a close-up front view of another embodiment of an exemplary Universal Speculum wherein the blade is at the top most position on the column and the blade assembly is pivoted. 
         FIG.  16   . Shows an isometric view of another embodiment of an exemplary Universal Speculum looking from the bottom up wherein the blade is extended and at the top most position on the column indicating the rotational angel of the blade motion. 
         FIG.  17   . Shows a side view of another embodiment of an exemplary Universal Speculum wherein the blade is extended and at the top most position on the column. 
         FIG.  18   . Shows a side view of another embodiment of an exemplary Universal Speculum wherein the blade is extended, on an angle, and at the top most position on the column. 
         FIG.  19   . Shows a side view of another embodiment of an exemplary Universal Speculum wherein the blade is extended and at the bottom most position on the column. 
         FIG.  20   . Shows a side view of another embodiment of an exemplary Universal Speculum wherein the blade is retracted, on an angle, and at the bottom most position on the column. 
         FIG.  21   . Shows an exploded view of another embodiment of an exemplary Universal Speculum indicating the four main components. 
         FIG.  22   . Shows a front view of another embodiment an exemplary Universal Speculum herein the blade is at the top most position on the column. 
     
    
    
     PARTS LIST 
     
         
           1 . Movable vacuum blade 
           2 . Fixed blade 
           3 . Blade Angle Mechanism 
           4 . Blade Assembly 
           5 . Columns 
           6 . Support Structure 
           7 . Slider track 
           8 . Blade Pivoting Mechanism 
           9 . Light assembly 
           10 . Slider Arm 
           11 . Clamping base assembly 
           12 . Blade vacuum opening 
           13 . Vacuum Connection 
           14 . Pivot Connection 
           15 . Lower Portion of Base Assembly 
           16 . Pivot track 
           17 . Base 
           20 . Rails 
       
    
     DETAILED DESCRIPTION 
     The Universal Vaginal Speculum disclosed addresses all the above-identified deficiencies of the current vaginal speculums. It adds additional features relative to those included in U.S. patent application Ser. No. 16,395,756, which is incorporated into this disclosure. 
     The disclosed speculum shown on the figures include a blade assembly ( 4 ) with which can be extended or retracted by virtue as warranted for a particular patient. The blade assembly includes a support structure ( 6 ) along with a movable suction blade ( 1 ), which glides over a fixed blade ( 2 ) in order to adjust to the length of the vaginal canal of the patient undergoing surgery. The movable blade ( 1 ) can also include an internal cavity with small openings ( 12 ) near the front edge and a vacuum connection ( 13 ) on the rear of the movable blade ( 1 ) to connect to standard medical vacuum tubing, which provides suction to remove surgical and bodily fluids present during operation. 
     The blade assembly is mounted on at least one column ( 5 ) which is mounted a clamping base assembly ( 11 ).  FIGS.  1 - 11    depict two columns ( 5 ) and  FIGS.  12 - 22    depict one columns ( 5 ). The base assembly ( 11  includes a base ( 17 ) in an upper portion of the base assemble which can be designed to slide between the top of the surgical table and the foam table pad. The lower portion of the base assembly ( 15 ) can include a clamping mechanism to secure the Universal Vaginal Speculum to a surgical table. The support structure ( 6 ) of the blades assembly ( 4 ) can further include slides ( 7 ) for mounting on the one or more columns ( 5 ) to which allows it to be positioned at any height along the height of the column(s) ( 5 ). 
     The Universal Vaginal Speculum can include a blade angle mechanism ( 3 ) to allow changing the angle of the blade assembly ( 4 ) in an upward or downward direction. One option for the blade angle mechanism ( 3 ), which is depicted on the figures, is a spring loaded ratcheting mechanism that allows the angle of the blade assembly ( 4 ) to be adjusted so that it corresponds to the vaginal pitch and thereby gain as much exposure as possible depicted on the figures. Other well-known mechanisms to adjust an angle can also be used. 
     Another feature depicted on the figures is a blade pivoting mechanism ( 8 ) to allow the blade assembly ( 4 ) to be rotated in a clockwise or counterclockwise direction. This provides improved access to the side walls of the vaginal canal. 
       FIGS.  1 - 11    depict one embodiment the pivoting mechanism ( 8 ) includes a pivot track ( 16 ) on which the blade assembly ( 4 ) support structure ( 6 ) slides to allow pivoting of the blades. 
       FIGS.  12 - 22    depict another embodiment the pivoting mechanism ( 8 ) in which the blade assembly includes a pivot connection ( 14 ) which allows the blade assembly ( 4 ) to pivot 360 degrees. 
       FIG.  2    shows the blade assembly attached to the slider track ( 16 ) that topically allows rotation of the blade assembly of at least 15 degrees to the right of the midline and at least 15 degrees to the left of the midline for vertical position.  FIG.  14    shows the blade assembly attached to a slider arm ( 10 ) via a pivoting connection ( 14 ) which allows for 360 degrees rotation of the blade assembly. 
     As shown on the drawings the blade assembly ( 4 ) is mounted on a support structure [ 6 ] with fasteners, which will allow the blade assembly ( 4 ) to travel up and down along one or more columns ( 5 ). It has a clamping base ( 11 ), which acts as the fulcrum, and at least one column ( 5 ) which allows for height adjustment of the blade assembly ( 4 ) from the surface of the surgical table to the posterior angle of the vaginal opening. The upper portion of the clamping base ( 11 ) is designed to slide between the top of the surgical table and the foam table pad, while the bottom screwing knob secures the base ( 17 ) to the table by clamping. 
     An additional, forward-facing, clip-on light assembly ( 9 ) can be added to improve visibility during operation. As shown in the drawings, the speculum may include rails ( 20 ), which are provided to allow an extension of the movable blade ( 1 ) beyond the length of the fixed blade ( 2 ). 
     The process/steps for use of the Universal Vaginal Speculum are as follows: 
     select a blade assembly comprising: a support structure and two blades wherein a first blade is a fixed blade and a second blade is a movable blade wherein the movable blade can extend beyond a length of the fixed blade; a blade angle mechanism as part of the blade assembly; a blade pivoting mechanism as part of the blade assembly; at least one column mounted on a base assembly; the blade assembly mounted on the at least one column on the base; 
     place the patient in the lithotomy position; 
     prep a patient and insert a pelvic drape between a pad and a hard surface of a table; 
     insert a base of the vaginal speculum between the pad and the hard surface of the table and secure the base to the table using a clamping mechanism; 
     extend the movable blade of the speculum to match a patient&#39;s depth of the vagina (blade assembly can be simultaneously inserted into the vagina); 
     adjust the height of the blade assembly such that the blades lie on the surface of the posterior wall of the vagina; 
     use the blade angle mechanism and the blade pivoting mechanism to achieved optimal exposure without undue pressure against the vaginal wall (once reaching the maximal achievable exposure without undue pressure on the posterior wall, the ratchet system will keep the blade in this fixed position); 
     Complete the draping 
     At the end of surgery, the following steps should be followed: 
     Adjust the blade angle mechanism and the blade pivoting mechanism as needed for removal of the vaginal, release the clamping mechanism, and remove the vaginal speculum. 
     The construction of the current Universal Vaginal Speculum is radically different in design from any other speculum on the market at this time. By re-designing the surgical vaginal speculum there is now no need to have a variety of speculums since the current speculum addresses all the deficiencies of the currently available speculums. 
     More specifically, it is self-retaining, adjusts for variable vaginal depths, adjusts to the variable posterior vaginal angle, and adjusts for increased access to the side walls, thus allowing for maximum exposure of the canal. 
     The new Universal Vaginal Speculum can be created in 4 components; blade assembly ( 4 ), extended blade ( 1 ), light ( 9 ), and clamping base assembly ( 11 ) which can be easily assembled and taken apart for proper sterilization ( FIG.  10   ). 
     The above is a detailed description of particular embodiments of the invention. It is recognized that departures from the disclosed embodiments may be made within the scope of the invention and that obvious modifications will occur to a person skilled in the art. Those of skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments which are disclosed herein and still obtain a like or similar result without departing from the spirit and scope of the invention. All of the embodiments disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.