Abstract:
A vaginal speculum having a universal connection between the handle and each of a plurality of blades, for selectively detaching and attaching one or more of the blades at any one of a plurality of angles between the handle axis and the blade axis. Preferably, the vaginal speculum is part of a kit having a plurality of elongated blades adapted to penetrate and fully enter a vagina while providing surgical access, each being interchangeably connectable to the handle, thereby providing a variety of options for blade length, blade width, or blade contour to better fit the vaginal structure of a particular patient. Each blade is made of a rigid or semi-rigid plastic, that is disposable after each use. The handle is preferably made of heavy metal, with a permanent plastic sheath or coating.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     The present invention relates to a weighted vaginal speculum of the type comprising an elongated blade having a contour adapted to penetrate and fully enter a vagina while providing surgical access, and an elongated, weighted handle connected to the blade, for initially manipulating the blade and providing a counter weight to the blade during surgery.  
         [0002]     A variety of vaginal specula have been used or described in printed publications, for maintaining access to a female vagina while the surgeon inserts various instruments along or through the blade to perform the necessary procedures within the vagina. Such specula have been adapted for use in conjunction with particular instruments, such as fiber optic cables, and other unique forms of diagnostic, monitoring and incision related equipment. In general these specula have been designed for compatibility with the type of diagnostic or surgical procedure, and in particular for unique instruments and equipment, rather than for the particular characteristics of the patient&#39;s anatomy.  
         [0003]     From patient to patient, the vagina can vary as to length, width, taper angle, and angle of the vaginal centerline relative to the surface of a surgery table on which the patient lies. In typical vaginal diagnostic or surgical procedures, the doctor or surgeon must adapt the positioning and support of the speculum to the particular characteristics of the patient&#39;s vagina. This adaptation is either very time consuming, for example, by selecting one of a plurality of available specula and trying one after the other until a good fit is obtained, or else using a standardized speculum that must be supported in an awkward or less than ideal orientation. Moreover, if multiple specula are tried before the “best fit” is identified, this requires that for each operation multiple specula be available, and multiple specula will require autoclave treatment before reuse.  
       SUMMARY OF THE INVENTION  
       [0004]     It is an object of the present invention to provide a vaginal speculum that is adjustable in the surgical field, as to one or both of blade length and blade angle.  
         [0005]     In one embodiment, each of a variety of blades is connectable to a universal handle.  
         [0006]     In another embodiment, any particular blade can be secured to a universal handle, at any of a range of angles.  
         [0007]     It is a preferred object of the present invention to provide a vaginal speculum having a universal connection between the handle and each of a plurality of blades, for selectively detaching and attaching one or more of the blades at any one of a plurality of angles between the handle axis and the blade axis.  
         [0008]     Preferably, the vaginal speculum is part of a kit having a plurality of elongated blades adapted to penetrate and fully enter a vagina while providing surgical access, each being interchangeably connectable to the handle, thereby providing a variety of options for blade length, blade width, or blade contour to better fit the vaginal structure of a particular patient.  
         [0009]     In another aspect, each blade is made of a rigid or semi-rigid plastic, that is disposable after each use. The handle is preferably made of heavy metal, with a permanent plastic sheath or coating. Having all the exposed surfaces as a plastic material is beneficial during cauterizing, both to minimize heat transfer to the surgeon&#39;s hand and/or the vaginal tissue at unwanted locations, and for easier grasping and handling by the surgeon.  
         [0010]     According to the invention, a master handle can be autoclaved and reused almost indefinitely, whereas bags of sterile blades can be easily manufactured, stored, and disposed of after use. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]      FIG. 1  is an elevational, partly tilted side view of the vaginal speculum according to the preferred embodiment of the invention;  
         [0012]      FIG. 2  is an elevational, partly tilted view, showing one side and the front of the speculum;  
         [0013]      FIG. 3  is a perspective view of the upper portion of the speculum handle, where the connection is made to the blade;  
         [0014]      FIG. 4  is a perspective view of the speculum, showing another side and the back; and  
         [0015]      FIG. 5  is an illustrative view of one blade suitable for connection to the handle.  
         [0016]      FIGS. 6-9  are show another embodiment with views corresponding to  FIGS. 1-3  and  5 , respectively; and  
         [0017]      FIGS. 10A and 10B  are schematic representations of one possible technique for the universal mounting of interchangeable blades having different angles relative to the handle. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0018]     A first embodiment of the invention will be described with reference to the accompanying  FIGS. 1-5 , with the overall device illustrated in  FIGS. 1 and 2 . The speculum  10  has a blade  12  attached to a handle  14  with an adjustable connection  16  therebetween. The blade has a distal end  18  and a proximal end  20 , and the handle has a weighted distal end  24  and a proximal end  26 . The connection  16  is between the proximal end  20  of the blade and the proximal end  26  of the handle.  
         [0019]     The blade  12  has a concave curvature in the base  28 , and upturned sidewalls  30 ,  32 , thereby providing a channel having an open front. The overall length, width, and contouring are adapted to penetrate and fully enter a vagina, such that the channel provides access for surgical instruments or diagnostic devices, as is well known. The proximal end of the blade  12  has a pair of transversely spaced apart connector tabs  34 , the purpose of which will be discussed further below. It should be appreciated that one can readily project a centerline through the channel, thereby defining a blade axis.  
         [0020]     The handle  14  preferably has a flat back  36  and substantially square side walls  38 . As shown in  FIG. 3 , the front of the handle preferably has a semicircular channel or the like  40  through which a centerline can establish a handle axis that intersects the blade axis at a particular included angle and together define a vertical plane of angulation. The proximal end  26  of the handle has a pair of transversely spaced apart connector bosses  42 , for connection to the spaced apart tabs  34  on the blade  12 .  
         [0021]     In use, the surgeon would hold the speculum in one hand, with the front of the handle facing the surgeon and the front of the blade extending away from the surgeon for entry into the vagina. After insertion of the blade  12 , the base  28  bears against the lower surface of the vagina, with much of the weight of the handle  14 .  
         [0022]     The preferred connection is effectuated between a mounting hole  46  on each connector boss  42 , and a pivot pin  44  projecting outwardly from each connector tab  34  at the proximal end of the blade  12 . This connection is easily made and broken in the surgical field by a surgeon. Preferably, the inside surface of the bosses  42  have channels  43  or the like, to facilitate the sliding of the pivot pins  44  into the holes  46 . For example, if the pin  44  has a nominal diameter D, the ends of the pins can be semi-circular with a maximum width transverse to the diameters, of D/2. The channel in the boss can have a width substantially equal to D/2 whereby when the blade  12  is substantially coaxially aligned with the channel, the pin can slide through the channel, into the hole  46 . Upon rotating the blade axis away from the handle axis, the pin will rotate within the hole  46  and will be trapped in the hole until the blade is again coaxially aligned with the handle.  
         [0023]     Not only is the selected blade easily attachable to the handle, but the surgeon has flexibility to select the ideal angulation between the blade and the handle. The spaced apart bosses  42  have a fan shaped region adjacent the mounting holes  46 , on which are formed a plurality of detents or slots  48  as shown in more detail in  FIGS. 3 and 4 . As shown in  FIG. 5 , the spaced apart connector tabs  34  also have an enlarged portion adjacent the pivot pins  44  on which is carried a tooth or the like  52 . When the connector bosses overlap the connector tabs and the mounting pins  44  are in the mounting holes  46 , the tooth  52  is situated in one of the plurality of angulation detents  48 . This relationship is analogous to a ratchet, such that the blade can either be attached, or once attached, adjusted, to any one of a plurality of angles between the angle axis and the blade axis.  
         [0024]      FIG. 4  also shows a continuity of the channel  40 , at the adjustable connection  16 , so that cables, instruments or the like that are within channel  40  can easily bend around the connection onto the channel of the blade.  
         [0025]     Of course, the mounting bores  46  and associated mounting pins  44  could be provided on the other of the bossed or tabs, with equivalent functionality and the tabs could be outside rather than inside the bosses.  
         [0026]     Not only can a particular blade be secured in any one of the plurality of angular relationship relative to the handle, but as shown in  FIG. 1 , the surgeon can have a plurality of blades, each having a different length, width, and/or contouring. One such additional blade is shown at  12 ′, having the same width and contour as blade  12 , but having a substantially longer length.  
         [0027]     The manual adjustablility of the angulation between the blade and the handle is indicated at alpha in  FIG. 1 . Even if the pivoting connection is permanent, the angulation feature still provides significantly greater flexibility to the surgeon than is available with conventional weighted specula. However, the preferred embodiment includes manual interchangeability and angulation. In this context, “manual” means that no tool, such a wrench, screw driver, hammer, or the like, is needed to make the adjustment.  
         [0028]      FIGS. 6-9  illustrate another embodiment of the invention. This embodiment of the weighted speculum  110  also has a blade  112  attached to a handle  114  with an adjustable connection  116  therebetween. The blade has a distal end  118  and a proximal end  120 , and the handle likewise has a distal end  124  and a proximal end  126 . The connection  116  is between the proximal end  120  of the blade and the proximal end  126  of the handle.  
         [0029]     The blade  112  has a concave curvature in the base  128 , and upturned sidewalls  130 ,  132 , and an upturned, spoon type, rather than open, front. The proximal end of the blade  112  has a pair of transversely spaced apart connector tabs  134 . The tabs in this embodiment are larger and more flexible, enhancing the surgeon&#39;s ability to quickly change the angle, or substitute a new blade. The underside of the blade has a multiplicity of spaced apart, transverse projecting ribs  154  that help retain the blade within the vagina during the medical procedure.  
         [0030]     This handle  114  has contoured back and side walls  136 ,  138 . As shown in  FIG. 8 , the front of the handle preferably has a semicircular channel or the like  140  through which a centerline can establish a handle axis that intersects the blade axis at a particular included angle. The proximal end  126  of the handle has a pair of transversely spaced apart connector bosses  142  that extend in parallel with the handle axis, rather than transversely as in the previously described embodiment, for connection to the spaced apart tabs  134  on the blade  112 . A ramp  156  extends obliquely to the axis at the base of the bosses, rising from the front toward the back of the handle.  
         [0031]     The connection is effectuated between a mounting hole  146  on each connector boss  142 , and a pivot pin  144  projecting outwardly from each connector tab  134  at the proximal end of the blade  112 . This connection is easily made and broken in the surgical field by a surgeon. Preferably, the inside surface of the bosses  142  have channels  143  or the like formed transversely to the handle axis, to facilitate the sliding of the pivot pins  144  into the holes  146 .  
         [0032]     The spaced apart bosses  142  have a region above the mounting holes  146  along the handle axis, on which are formed a plurality of detents or slots  148 . As shown in  FIG. 9 , the spaced apart connector tabs  134  also have an enlarged portion for the pivot pins  144  and a tooth or the like  152  which is spaced generally above the pin, i.e., the spacing direction is transverse to the blade axis. When the connector bosses overlap the connector tabs and the mounting pins  144  are in the mounting holes  146 , the tooth  152  is situated in one of the plurality of angulation detents  148 . The blade can either be attached, or once attached, adjusted, to any one of a plurality of angles between the handle axis and the blade axis. The contouring of the tabs  134  is convex at the back  158  and substantially flat at the bottom  160 , such that shape of the tabs  134  permits the edge of the tab to be placed on the ramp  156  of the handle for easy alignment of the pins  144  with the channels  143  and sliding through until the pins snap into the mounting holes  146 . When the blade and handle are connected, the back  158  of the tabs extends beyond the boss (see  FIG. 6 ), whereby the surgeon can squeeze the tabs toward each other to facilitate change of blade or angulation. The edge of the tabs also provides support as the tabs  134  are pivoted to adjust the angulation, facilitating angulation adjustment while the blade is in the vagina.  
         [0033]     Those familiar with this field of technology can readily appreciate the significant advantages arising from the use of a universal handle that can be autoclaved and reused, in conjunction with a wide range of blade sizes, contours, and angulation that can be quickly selected and implemented in the surgical field. For example, once the patent is in the proper position for examination or surgery, the surgeon can open a bag of sterilized blades of varying sizes and/or contours, from experience and a modest degree of trial and error, select the blade that is most suitable for the particular procedure to be performed. Upon selection of that blade, the surgeon can then easily attach that particular blade to the handle and at a best-guess angulation. Upon insertion of the blade into the vagina, the angulation can be checked and, if necessary slight adjustments made. With the present invention, such adjustment can, be made while the blade remains in the vagina. Optionally, the blade can be removed to make the adjustment.  
         [0034]     In another approach, the surgeon can make an educated selection of a particular blade and angle that should be suitable, and connect such blade to the handle at such angle. The blade can then be inserted in the vagina and the handle positioned in accordance with the contemplated surgical procedure. If the combination of blade length and angulation are not ideal, the surgeon can adjust the angulation either while the blade is in the vagina or after the blade has been removed.  
         [0035]     In a relatively simple kit, three blades of different length and proportional contouring would be available to the surgeon. Whether only one, or all three are tried before deciding on the final combination of blade and handle, the cost-effectiveness of quickly achieving an optimum fit while using only one component that requires autoclaving (the handle), and disposing of rather than requiring autoclaving of the blades, should be very attractive.  
         [0036]     It should be appreciated that the invention also encompasses embodiments that may not provide all the advantages or achieve all the objectives set forth herein. For example, at a first, basic level, the angular adjustablility of a fixed blade, or the combination of a universal, reusable handle with a uniform, disposable blade, achieves advantages relative to current practice. Moreover, in the next level of innovation, such uniform, disposable blade is adjustable to any one of a range of angles relative to the handle. Yet another aspect of improvement relative to the basic innovation, is in the form of a kit comprising a plurality of blades of different size, angle of projection and/or contouring that are interchangeably connectable to a universal handle. Of course, the most advantageous embodiment of the invention includes interchangeability of blades of different size and/or contour, with each blade also being adjustable as to angulation relative to the handle.  
         [0037]     It should also be appreciated that the use of tabs and bosses with pivot pin for making the connection between the blade and the handle as described above, is only one of many techniques for implementing the invention. This particular connection achieves three functions between the tabs and the bosses: 
        (1) attaches the blade to the handle so that they do not separate,     (2) provides a rotational degree of freedom for permitting adjustment of the angulation; and     (3) provides fixation of the angle as selected by the surgeon. 
 
 In the illustrated embodiments, the interaction of the pivot pins  44 ,  144  and the mounting holes  46 ,  146  achieves functions (1) and (2), whereas the detents  48 ,  148  and associated tooth  52 ,  152  provide the function (3). 
       
 
         [0041]     In less comprehensive embodiments, function (2) may not be present at the connection. For example, for any given blade, the attachment to the handle establishes a constant angulation. In one such implementation, a plurality of blades having different lengths would all be securable interchangeably, but at the same angle, relative to the handle. In another variation, the kit contains blades of three different sizes, with each such size having three angle variations that are determined by the size and/or shape of the blade structure that connects to the handle. This attachment concept is illustrated in  FIG. 10 .  FIG. 10A  is a schematic representation of a connection  216  on the handle having a slot or other receiving cavity  246  in which a connecting projection  244  associated with blade  212 A is securable, thereby establishing a particular orientation of blade axis  212 A′.  FIG. 10B  shows the same connecting structure  216  on the handle and the same projection  244  on the blade  212 B, but in this instance the orientation of the blade relative to the projection  244  is along a different axis  212 B′. In this manner, several blades having the same length and/or contour are available to provide a different angulation for the speculum, while using the same mounting on the universal handle.  
         [0042]     Other ways of achieving the same effect as described with respect to  FIGS. 10A and 10B  are also possible, such as a variable wedge projection corresponding to projection  244  on the blade with a constant or varying inverse wedge corresponding to  246  on the handle, with associated clamping for securing the blade to the handle, e.g., bayonet or similar mounts.  
         [0043]     Furthermore, other functionally equivalent, manually adjustable techniques for making, tightening or loosening the connection for one or both of blade interchangeability or blade angulation, should be considered as falling within the scope of the invention. These can include bolts and associated wing nuts, spring pin detents, or ratchet rollers. These may not facilitate the speed of change afforded by the preferred embodiments, but to the extent these fall within the literal and equivalent scope any claims, they should be deemed within the scope of the invention.