Abstract:
A vaginal speculum includes a pair of opposed blades. One of the opposed blades is movably mounted for controllable movement towards and away from the other of the pair of opposed blades. Each blade includes an elongate arcuate paddle defining an interior compartment between the paddles. A solid rounded lip defines the terminal end of each side and the distal end of the blades. The lips may comprise a unitary structure which may be integrally formed with the paddle or separately formed and attached to each paddle such as by welding or mechanical attachment. The solid rounded lips protrude laterally from the first and second sides and the distal end of the blade to provide a smooth brim configured to urge tissue away from the blade. The solid rounded lip is preferably flush with the interior compartment defined by each elongate arcuate paddle. The solid rounded lip has a major radius of at least 2 mm and preferably 2 mm to 5 mm and approximately ½ to 1/20 times the blade radius.

Description:
FIELD OF THE INVENTION 
       [0001]    This invention generally relates to a vaginal speculum used for inspection of the vagina and cervix, and, more particularly, to a speculum having a solid rounded lip forming the free edge of each speculum blade. 
       BACKGROUND 
       [0002]    A vaginal speculum is a diagnostic instrument for dilating the opening of the vagina cavity to facilitate access for observation and treatment. A typical prior art vaginal speculum  100 , as shown in  FIGS. 1 and 2 , has a pair of blades  110 ,  145 , each having a curved distal end  105 ,  150 . The blades  110 ,  145  are inserted into the vagina in a closed state, with the distal ends  105 ,  150  initiating penetration into the vagina. When the blades  110 ,  145  are fully inserted the handles  125 ,  140  are squeezed towards one another, causing one blade (i.e., the upper blade  110  in the example speculum shown in  FIGS. 1 and 2 ) to pivot away from the opposite blade (i.e., the lower blade  145  in the example speculum shown in  FIGS. 1 and 2 ). The pivoting movement of the blade  110  dilates the vaginal cavity. An adjustment fork  135  and threaded locking nut  130  are provided to enable vertical adjustment of the distance between the pivoting axis of the upper blade  110  and the pivoting axis of the lower blade  145 . Thus, the speculum  100  may be adjusted to work within narrow and wide vaginal orifices, such as openings widened due to loss of muscle tone as a result of age or previous childbirths. A threaded locking shaft  120  and nut  115  are also provided to hold the upper blade  110  in an opened position within a dilated vaginal cavity. 
         [0003]    Unfortunately, patients frequently complain that conventional vaginal specula cause extreme discomfort. Such devices are typically comprised of surgical steel or like material, which can be sterilized in an autoclave before use. Such materials are initially unpleasantly cold to the touch. 
         [0004]    Dilation of the vaginal orifice and cavity with a conventional surgical steel speculum can be quite painful. Even when the blades  110 ,  145  are in a closed position, portions of the free edges  155  are exposed. The free edges  155  of the blades  110 ,  145  tend to be thin and feature sharp right angle, bevelled or chamfered corners. As the speculum blades  110 ,  145  are urged into a vaginal cavity, tissue that projects against the free edges  155  is scraped. As the blades  110 ,  145  are pivoted to dilate the vaginal cavity, tissue projected against the exposed free edges is grated. As the opening of the vagina has a circular muscle that is more resistant to dilations than the vaginal cavity, during withdrawal the speculum blades must be collapsed. Pivotal movement of the blades towards each other pinches protruding tissue. This scraping and pinching cause discomfort as well as trauma to the vaginal tissue. 
         [0005]    What is needed is an improved speculum that prevents or minimizes scraping and pinching of vaginal tissue caused by conventional specula. The improved speculum should be compatible with surgical steel or like materials for durability and to permit sterilization using conventional techniques (e.g., in an autoclave). The invention is directed to overcoming one or more of the problems and solving one or more of the needs as set forth above. 
       SUMMARY OF THE INVENTION 
       [0006]    To solve one or more of the problems set forth above, in an exemplary implementation of the invention, a speculum having a rounded lip forming the free edge of each speculum blade is provided. The vaginal speculum includes a pair of opposed blades configured for insertion into a vaginal orifice. One of the opposed blades is movably mounted for controllable movement towards and away from the other of the pair of opposed blades. Each blade includes an elongate arcuate paddle defining an interior compartment. The elongate arcuate paddle has first and second sides, a proximal end and a distal end. Each of the first and second sides, proximal end and distal end have a terminal end. Each blade further includes a solid rounded lip defining the terminal end of each of the first and second sides. Each blade further includes a solid rounded lip defining the terminal end of the distal end. The movably mounted opposed blade is pivotally mounted for pivoting movement towards and away from the other of the pair of opposed blades. The distal end of each blade comprises a spheroid quadrant formed integrally with the elongate arcuate paddle. The lips may comprise a unitary structure which may be integrally formed with the paddle or separately formed and attached to each paddle such as by welding or mechanical attachment. The solid rounded lips protruding laterally from the first and second sides and the distal end of the blade to provide a smooth brim configured to urge tissue away from the blade. The solid rounded lip is preferably flush with the interior compartment defined by each elongate arcuate paddle. The solid rounded lip has a major radius of at least 2 mm and preferably 2 mm to 5 mm and approximately ½ to 1/20 times the blade radius, which is large enough to comfortably distribute stresses on contacted vaginal tissue. The speculum is comprised of surgical stainless steel, or other metal such as martensitic steel, austenitic steel, titanium, and titanium alloy, or a plastic such as polysulphone, polyetherimide, polyphenylsulfone, polyphenylene sulfide, polyetheretherketone, and syndiotactic polystyrene. The material is capable of withstanding repeated sterilization in an autoclave. 
         [0007]    The exemplary speculum features blades with solid rounded lips extending outwardly from the free edges of the blades. Advantageously, each lip is a solid structure that prevents infiltration by contaminants and entrapment of tissue. Each lip is comprised of a material that can be sterilized in an autoclave or using other conventional sterilization techniques, if the device is reusable. Each lip protrudes laterally from the side edges and distal end of the blade body to provide a smooth brim that urges adjacent tissue away from the blade, without encroaching into or comprising visibility through the interior compartment defined by the space between the blades. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    The foregoing and other aspects, objects, features and advantages of the invention will become better understood with reference to the following description, appended claims, and accompanying drawings, where: 
           [0009]      FIG. 1  is a side view of an exemplary prior art speculum; and 
           [0010]      FIG. 2  is a perspective view of the exemplary prior art speculum; and 
           [0011]      FIG. 3  shows a perspective view of an exemplary upper blade of an exemplary speculum according to principles of the invention; and 
           [0012]      FIG. 4  shows a perspective view of an exemplary lower blade of an exemplary speculum according to principles of the invention; and 
           [0013]      FIG. 5  shows a side view of an exemplary speculum according to principles of the invention; and 
           [0014]      FIG. 6  shows a perspective view of an exemplary speculum according to principles of the invention; and 
           [0015]      FIG. 7A  shows a profile view of a section of an exemplary blade of a speculum according to principles of the invention; and 
           [0016]      FIG. 7B  shows a perspective view of a section of an exemplary blade of a speculum according to principles of the invention; and 
           [0017]      FIG. 8A  shows a profile view of a section of an exemplary blade of a speculum according to principles of the invention; and 
           [0018]      FIG. 8B  shows a perspective view of a section of an exemplary blade of a speculum according to principles of the invention; and 
           [0019]      FIG. 9A  shows a profile view of a section of an exemplary blade of a speculum according to principles of the invention; and 
           [0020]      FIG. 9B  shows a perspective view of a section of an exemplary blade of a speculum according to principles of the invention; and 
           [0021]      FIG. 10A  shows a perspective view of a section of an exemplary rounded lip of a speculum according to principles of the invention; and 
           [0022]      FIG. 10B  shows a plan view of a section of an exemplary rounded lip of a speculum according to principles of the invention; and 
           [0023]      FIG. 11A  shows a close-up plan view of a rounded lip of a speculum according to principles of the invention; and 
           [0024]      FIG. 11B  shows a close-up plan view of another rounded lip of a speculum according to principles of the invention; and 
           [0025]      FIG. 12A  shows a profile view of a section of an exemplary rounded lip of a speculum according to principles of the invention; and 
           [0026]      FIG. 12B  shows a perspective view of a section of an exemplary rounded lip of a speculum according to principles of the invention; and 
           [0027]      FIG. 13A  shows a profile view of a section of an exemplary rounded lip of a speculum according to principles of the invention; and 
           [0028]      FIG. 13B  shows a perspective view of a section of an exemplary rounded lip of a speculum according to principles of the invention. 
       
    
    
       [0029]    Those skilled in the art will appreciate that the figures are not intended to be drawn to any particular scale; nor are the figures intended to illustrate every embodiment of the invention. The invention is not limited to the exemplary embodiments depicted in the figures or the speculum, shapes, relative sizes, ornamental aspects or proportions shown in the figures. 
       DETAILED DESCRIPTION 
       [0030]    Referring to the Figures, in which like parts are indicated with the same reference numerals, various views of an exemplary speculum and components thereof according to principles of the invention are shown. The term “speculum” is used herein for convenience to refer to any vaginal speculum with a pair of opposed blades, regardless of the orientation of the blades. The invention is not limited to the particular exemplary speculum shown in the Figures. Instead, the invention may be utilized with any type of vaginal speculum with a pair of opposed blades, in any sizes. 
         [0031]    Referring now to  FIG. 3 , a perspective view of an exemplary upper blade  300  is conceptually illustrated. The upper blade  300  has a generally L-shaped configuration with a blade body  110  configured (i.e., sized and shaped) for insertion into a vaginal orifice, and a handle  125  substantially perpendicular to the blade body  110 . The blade body  110  has a semicircular or concave cross-section. The distal end  105  of the blade  300 , i.e., the end opposite to the handle  125 , is a spherical (or nearly spherical) quadrant  105  formed integrally with the remaining body of the blade  110 . 
         [0032]    A smooth rounded lip  305 ,  310 ,  315  covers the free edge of each side of the blade  300 , including the free edge of the distal end  105 . The rounded lip  305 ,  310 ,  315  may be a separate structure attached to or formed integrally with the blade body  110  and distal end  105 . The rounded lip  305 ,  310 ,  315  protrudes laterally from the edge of the blade body  110  and distal end  105  to provide a smooth brim that urges adjacent tissue away from the blade  300 . The lip is preferably solid, as a hollow or rolled structure is conducive to infiltration by contaminants and tissue and entrapping contaminants in the compartment of the hollow or rolled structure. 
         [0033]    Referring now to  FIG. 4 , a perspective view of an exemplary lower blade  400  is conceptually illustrated. Like the upper blade  300 , the lower blade  400  has a generally L-shaped configuration with a blade body  145  configured (i.e., sized and shaped) for insertion into a vaginal orifice, and a handle  140  substantially perpendicular to the blade body  145 . The blade body  145  has a semicircular or concave cross-section. The distal end  150  of the blade  400 , i.e., the end opposite to the handle  140 , is a spherical (or nearly spherical) quadrant  150  formed integrally with the remaining body of the blade  145 . The lower blade  400  is longer than the upper blade  300 , enabling the distal end  150  of the lower blade  400  to extend beneath the ectocervix. 
         [0034]    As with the upper blade  300 , a smooth rounded lip  405 ,  410 ,  415  covers the free edge of each side of the blade  400 , including the free edge of the distal end  150 . The rounded lip  405 ,  410 ,  415  may be a separate structure attached to or formed integrally with the blade body  145  and distal end  150 . The rounded lip  405 ,  410 ,  415  protrudes laterally from the edge of the blade body  145  and distal end  150  to provide a smooth brim that urges adjacent tissue away from the blade  400 . 
         [0035]    Referring to  FIGS. 5 and 6 , side and perspective views of an exemplary vaginal speculum  100  having a pair of blades  300 ,  400  equipped with rounded lips is conceptually shown. The blades  300 ,  400  are configured for insertion into a vaginal orifice in a closed state, with the distal ends  105 ,  150  initiating penetration into the vagina. When the blades  300 ,  400  are fully inserted, the handles  125 ,  140  are squeezed towards one another, causing one blade (i.e., the upper blade  300  in the example speculum shown in  FIGS. 5 and 6 ) to pivot away from the opposite blade (i.e., the lower blade  400  in the example speculum shown in  FIGS. 5 and 6 ). The pivoting movement of the blade  300  dilates the vaginal cavity. An adjustment fork  135  and threaded locking nut  130  are provided to enable vertical adjustment of the distance between the pivoting axis of the upper blade  300  and the pivoting axis of the lower blade  400 . Thus, the speculum  100  may be adjusted to work within narrow and wide vaginal orifices, such as openings widened due to loss of muscle tone as a result of age or previous childbirths. A threaded locking shaft  120  and nut  115  are also provided to hold the upper blade  300  in an opened position within a dilated vaginal cavity. 
         [0036]    As discussed above, a smooth rounded lip  305 ,  310 ,  315  covers the free edge of each side of the blade  300 , including the free edge of the distal end  105 . The rounded lip  305 ,  310 ,  315  may be a separate structure attached to or formed integrally with the blade body  110  and distal end  105 . The rounded lip  305 ,  310 ,  315  protrudes laterally from the edge of the blade body  110  and distal end  105  to provide a smooth brim that urges adjacent tissue away from the blade  300 . 
         [0037]    As with the upper blade  300 , a smooth rounded lip  405 ,  410 ,  415  covers the free edge of each side of the blade  400 , including the free edge of the distal end  150 . The rounded lip  405 ,  410 ,  415  may be a separate structure attached to or formed integrally with the blade body  145  and distal end  150 . The rounded lip  405 ,  410 ,  415  protrudes laterally from the edge of the blade body  145  and distal end  150  to provide a smooth brim that urges adjacent tissue away from the blade  400 . 
         [0038]    The upper and lower blades  300 ,  400  have similar or identical cross-section shapes. Illustratively, exemplary embodiments of section A-B of the exemplary lower blade  400  are shown in  FIGS. 7A ,  7 B, and  FIGS. 8A ,  8 B, and  FIGS. 9A ,  9 B. In each example, the rounded lip does not protrude substantially, if at all, into the interior compartment defined by the blade. Thus, the lip does not impede visibility through the interior compartment. In each example, the rounded portion of the lip protrudes outwardly in a lateral direction from the blade. The outward rounded protrusion comprises a smooth brim that urges tissue away from the edge of the blade  400 . The major radius r 2  (i.e., the largest most prominent radius) of the protrusion is approximately at least 2 mm, which provides a broad enough surface to comfortably distribute force exerted on abutting tissue, avoid stress concentrations, and maintain a safe distance between the tissue and the interior compartment defined by the blades. A major radius r 2  of approximately 2 mm to 5 mm is preferred. The radius r 1  of the blades is approximately 10 mm to 20 mm. Thus, the preferred ratio of the blade radius r 1  to the protrusion radius r 2  is approximately 2 to 10. In the embodiments illustrated in  FIGS. 8A ,  8 B and  FIGS. 9A ,  9 B, the outwardly projecting portion of the lip eases into a convex curve that gradually merges with the blade, forming a teardrop shape. 
         [0039]    Referring now to  FIGS. 10A ,  10 B,  11 A and  11 B, embodiments with rounded lips having broad lateral edges, i.e., a flat or substantially flat lateral edge or a lateral edge with a relatively large radius of curvature r 5 , and a relatively small superior lateral radius r 4  and a relatively small inferior lateral radius r 6 . Superior and inferior medial radii r 3  and r 7  provide a smooth gradual curved transition from the lip to the blade. The lip profile (i.e., a section plan view as illustrated in  FIGS. 11A and 11B ) generally has a shape of a rectangle with rounded corners or a superellipse, Lamé curve, squircle, filleted square or filleted rectangle. Other profiles resembling a circle, oval, ellipse, ellipsoid, hyperellipse, hypoellipse, parabola, may also be utilized and are intended to come within the scope of the invention. The rounded lip does not protrude substantially, if at all, into the interior compartment defined by the blade. Thus, the lip does not impede visibility through the interior compartment. In each example, the lip protrudes outwardly in a lateral direction from the blade. The outward protrusion comprises a smooth brim with a broad lateral edge that distributes stress, avoids stress concentrations, and urges tissue away from the edge of the blade  400 . The major radius r 5  (i.e., the largest most prominent radius) of the protrusion is approximately at least 2 mm, which provides a broad enough surface to comfortably distribute force exerted on abutting tissue, avoid stress concentrations, and maintain a safe distance between the tissue and the interior compartment defined by the blades. The major radius r 5  is approximately at least twice the thickness t of the blade, and preferably approximately 2 to 5 times the thickness t of the blade. A major radius r 2  of approximately 2 mm to 5 mm is preferred. The other lateral radii r 4  and r 6  are smaller than the major radius. Lateral and medial transitional radii r 3  and r 7  are configured to provide a smooth, gradual, curved transition from the rounded lip to the blade. In the embodiments illustrated in  FIGS. 10A ,  10 B and  FIGS. 11A ,  11 B, the outwardly projecting portion of the lip eases into a convex curve that gradually merges with the blade. 
         [0040]    The lips  400 ,  500  may be integrally formed with the blades  110 ,  145  or separately formed and attached to the blades  110 ,  145 . Blades  110 ,  145  with integrally formed lips may be produced by machining or casting. Rounded edges may be formed by folding blade material. In a preferred embodiment, the folded sections are tightly packed to avoid formation of any cavities or compartments that may otherwise entrap contaminants. 
         [0041]    Separately formed lips  400 ,  500  may be surface mounted to edges of the speculum blades  110 ,  145 . Alternatively, the separately formed lips  400 ,  500 , sections of which are conceptually illustrated in  FIGS. 12A ,  12 B,  13 A and  13 B, may include a channel  415  or cutout  510  to receive the free edge of a blade  110 ,  145 . The channel  415  or cutout  510  may be sized and shaped to securely receive the free edge. In a preferred implementation, the channel or cutout is off-center relative to the cross-section of the lip. This eccentric arrangement positions the edge of the blade flush (as in  FIGS. 13A ,  13 B) or nearly flush with a side of the lip. A transition  410  may be provided to smoothly merge with the free edge of the blade. Thus, the rounded lip does not protrude substantially, if at all, into the interior compartment defined by the blade. Consequently, the lip does not impede visibility through the interior compartment formed by the blade. Concomitantly, the rounded portion  405 ,  505  of the lip  400 ,  500  protrudes outwardly in a lateral direction from the blade. The outward rounded protrusion comprises a smooth brim that urges tissue away from the edge of the blade  110 ,  145 , minimizes or eliminates sharp edges that contact adjacent tissue and reduces and/or eliminates pinching. The rounded protrusion also facilitates insertion of the speculum blades into the vaginal cavity. The invention is not limited to the attachable circular projection illustrated in  FIGS. 12A ,  12 B,  13 A and  13 B. Other rounded configurations, including but not limited to the teardrop shapes, of  FIGS. 8A ,  8 B,  9 A and  9 B, may comprise attachable lips in accordance with principles of the invention. 
         [0042]    The lips and blades may be comprised of the same materials. In a preferred embodiment, the composition is stainless steel, particularly surgical stainless steel, which is easy to clean and sterilize, strong and corrosion-resistant. However, the invention is not limited to a particular material. Other materials suitable for medical device manufacture may be used within the scope of the invention. For example, other metals such as other martensitic steels, austenitic steels, titanium and alloys thereof may be utilized. Additionally, medical equipment grade plastics may be used in disposable and reusable embodiments. By way of example and not limitation, polysulphone, polyetherimide, polyphenylsulfone, polyphenylene sulfide, polyetheretherketone, and syndiotactic polystyrene, are plastic materials of choice for implementations that can be autoclaved. 
         [0043]    In embodiments where the lips  400 ,  500  are separately formed and attached to the blades  110 ,  145 , welding, soldering, brazing and mechanical attachments may be utilized. Welding entails coalescence by melting the work pieces (i.e., the blades and lips) and adding a filler material to form a pool of molten material (i.e., a weld puddle) that cools to become a strong joint. Soldering and brazing involve melting a lower-melting-point material between the work pieces to form a bond between them, without melting the work pieces. Attachment comprising mechanical joints, such as interlocking tongue and groove joints may also be used. 
         [0044]    In embodiments where the lips  400 ,  500  are separately formed and attached to the blades  110 ,  145 , casting and machining operations may be utilized. Machining operations include turning, milling, drilling, and grinding operations. 
         [0045]    Advantageously, regardless of the method of manufacture, the resulting speculum features blades with rounded lips extending outwardly from the free edges of the blades. Each lip is a solid structure that prevents infiltration by contaminants and entrapment of tissue. Each lip is comprised of a material that can be sterilized in an autoclave or using other conventional sterilization techniques, if the device is reusable. Each lip protrudes laterally from the side edges and distal end of the blade body to provide a smooth brim that urges adjacent tissue away from the blade. 
         [0046]    While an exemplary embodiment of the invention has been described, it should be apparent that modifications and variations thereto are possible, all of which fall within the true spirit and scope of the invention. With respect to the above description then, it is to be realized that the optimum relationships for the components and steps of the invention, including variations in order, form, content, function and manner of operation, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. The above description and drawings are illustrative of modifications that can be made without departing from the present invention, the scope of which is to be limited only by the following claims. Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents are intended to fall within the scope of the invention as claimed.