Patent Publication Number: US-2023148856-A1

Title: Vaginal speculum and cervical screening kit

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to the U.S. Provisional Application No. 63/280,438, filed on Nov. 17, 2021, entitled “VAGINAL SPECULUM AND CERVICAL SCREENING KIT”. The contents of the above-noted application are incorporated herein by reference as if set forth in full and priority to this application is claimed to the full extent allowable under U.S. law and regulations. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to vaginal specula and, in particular, to a radially expanding speculum that improves visualization of the cervix and thereby enhances cervical analysis and procedures as well as associated structure for facilitating mounting of auxiliary equipment, e.g., for imaging or executing transvaginal medical procedures. 
     BACKGROUND 
     Vaginal specula are used to dilate the vagina and visualize the uterine cervix to screen and treat for cancerous and benign lesions of the cervix. Generally, existing vaginal specula are two-bladed including a stationary blade (relative to the speculum handle) and a pivoting blade. Some designs allow the pivot point to move linearly away from the stationary blades. Nonetheless, the moveable blade is substantially limited to moving away from and back towards the stationary blade in relation to one axis. 
     There are several drawbacks to existing speculum designs. The most important of these is the potential failure to fully visualize the cervix which could lead to failure to diagnose cervical cancer—a life threatening condition. In some women, with the two-bladed speculum, the vaginal walls collapse between the two-blades and obscure the view of the cervix. The current two-bladed design has relatively large blades that are difficult to introduce into the vagina of an apprehensive patient. In addition, the current speculum also does not take into account the variation in patient anatomy. The uterine cervix typically sits at a 90° angle to the vagina. The two-bladed speculum, as designed, opens asymmetrically. This may cause excessive dilation in certain parts of the vagina thus causing discomfort to the patient. Moreover, when closing and removing the two-bladed speculum, there are two “pinch points” along the length of the blade members, which can cause patient discomfort upon closing of the blades in preparation for withdrawal. 
     As noted above, the speculum may be used for diagnosis and treatment. Diagnosis or screening involves employing a speculum to visualize the patient&#39;s cervix and, in some cases, may further involve obtaining images of the cervix. Such images may be analyzed manually or by employing a digital analysis tool, e.g., accessed via a network. For example, a culposcope may be used for visualization as well as to obtain images for further analysis. Conventional culposcopes are large pieces of equipment supporting, in some cases, a binocular imaging system that can be positioned to view the patient&#39;s cervix through the central opening of a speculum. If a lesion or other condition of concern is identified, treatment may involve cryoablation, electrosurgical incision, or other transvaginal procedures via the central opening of the speculum. 
     Such diagnosis and treatment can be cumbersome to execute, sometimes requiring multiple skilled clinicians or otherwise involving some risk of misdiagnosis, mistreatment, or incomplete care. In particular, it is difficult for a single clinician to properly position the speculum while manipulating other equipment so that optimal visualization, imaging, or treatment can be executed. For example, positioning a colposcope may require a clinician to release the speculum. However, if pressure is released from the speculum, the speculum may be moved out of position or ejected from the patient, potentially requiring the use of a new speculum or at least requiring the speculum to be reinserted or repositioned, thus involving further discomfort for the patient and extending examination times. To avoid such outcomes, multiple clinicians may be involved but that may increase expense and be impractical for already underserved populations. 
     SUMMARY 
     The present invention is directed to a speculum that facilitates mounting of auxiliary equipment. In this manner, the clinician&#39;s hands are freed for use in additional procedures such as imaging or other medical procedures. In addition, a clinician may be able to utilize multiple pieces of equipment—such as a speculum, and electrosurgical instrument, and a smoke evacuation system—in a limited space, thereby potentially improving procedures and outcomes. A clinician can also readily implement cervical imaging processes and access diagnostic processing systems, including via remote processing platforms. In certain implementations, such functionality can be implemented using relatively low cost and readily available equipment and devices. The invention may also reduce the personnel required by a clinic to implement a range of diagnostic and treatment functions, thereby reducing costs and improving service for underserved populations. 
     In accordance with one aspect of the present invention, a method and apparatus (“utility”) is provided for use in cervical imaging and diagnosis. The utility generally involves a speculum, an imaging system, and a data network. The speculum includes a distal portion, for positioning within a subject to dilate the subject to provide an enlarged opening to the subject&#39;s cervix in alignment with an axis of the speculum, and a proximal portion including a handle for gripping. The imaging system is employed for obtaining one or more images of the subject&#39;s cervix via the enlarged opening of the speculum. The data network is operatively associated with the imaging system for transmitting the images, via a data network, to a remote data terminal for analysis. The speculum further includes a mount for receiving structure of the imaging system in an imaging position in relation to the speculum for imaging the subject&#39;s cervix. The invention thus facilitates coordinated operation of a speculum and an imaging system thereby simplifying imaging and potentially improving results and reducing costs. 
     In one implementation, the imaging system includes a smart phone and the mount comprises an assembly for supporting the phone. For example, the support assembly may be disposed on a handle of the speculum. Preferably, the support assembly is movable in relation to the handle of the speculum to enable positioning of the phone for acquiring images as well as allowing the phone to be moved aside to accommodate other procedures. Alternatively, the imaging assembly may include an imaging detector and an optical element for use in transmitting imaging information from an optical interface to an imaging detector. In such cases, the mount may be adapted for supporting the detector or optical element. 
     In accordance with another aspect of the present invention, a utility is provided for facilitating mounting of auxiliary equipment for use with a speculum. The utility generally involves a speculum and a mounting system for mounting a medical device. The speculum includes a petal assembly, for positioning within an introitus of a subject to dilate the subject so as to provide an enlarged opening to the subject&#39;s cervix, and a dilator, separate from the petal assembly, for dilating and contracting the petal assembly. The mounting system is adapted for mounting the medical device on the dilator. For example, the mounting system may be adapted for holding a smoke evacuation tube, an imaging element of an imaging system, or equipment for executing a transvaginal procedure via a central opening of the speculum. 
     It will be appreciated that, among other things, the invention encompasses a speculum, methods for making and using the speculum, cervical screening and treatment processes involving the speculum and associated processing systems. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a more complete understanding of the present invention, and further advantages thereof, reference is now made to the following detailed description taken in conjunction with the drawings in which: 
         FIGS.  1 A and  1 B  show perspective views of a vaginal speculum, constructed in accordance with the present invention, in a contracted (closed) and an expanded (open) configuration, respectively; 
         FIGS.  2 A and  2 B  illustrate a vaginal speculum in accordance with the present invention in contracted and expanded configurations, respectively, where the speculum in shown inserted into the introitus of a patient and certain physiology of the patient is depicted for purposes of illustration; 
         FIGS.  3 A and  3 B  are perspective views of a vaginal speculum, in accordance with an alternate embodiment of the present invention, in expanded and contracted configurations, respectively; 
         FIG.  3 C  is a side view of the speculum of  FIGS.  3 A- 3 B  in the contracted configuration; 
         FIG.  3 D  is a side view of the speculum of  FIG.  3 A  in the expanded configuration; 
         FIG.  3 E  is a end view of the dilation assembly of the speculum of  FIGS.  3 A- 3 B ; 
         FIG.  3 F  is a expanded view of the worm gear ratchet mechanism of the speculum of  FIGS.  3 A and  3 B ; 
         FIG.  3 G  is a expanded view of the linkage for interconnecting the worm gear racket assembly to the dilation assembly of the speculum of  FIGS.  3 A and  3 B . 
         FIG.  4 A  shows a speculum, in accordance with a still further embodiment of the present invention, positioned for inspection of a patient&#39;s cervix; 
         FIGS.  4 B- 4 C  are side views showing the speculum of  FIG.  4 A  in the open and closed configurations respectively; 
         FIGS.  4 D- 4 E  show perspective views of a portion of the speculum of  FIG.  4 A  in the open and closed configurations, respectively; 
         FIGS.  5 A- 5 B , are perspective views of a speculum, in accordance with another embodiment of the present invention, in closed and open configurations, respectively; 
         FIGS.  5 C- 5 D , are top views of the speculum of  FIGS.  5 A- 5 B  in the closed and open configurations, respectively; 
         FIGS.  5 D- 5 F  are side views of distal end petal portions of the speculum of  FIGS.  5 A- 5 B  in the closed and open configurations, respectively; 
         FIG.  6 A  is a side view of a speculum constructed in accordance with the present invention in a contracted configuration; 
         FIG.  6 B  is a side view of the speculum of  FIG.  6 A  in a dilated configuration; 
         FIG.  7 A  is a perspective view of a speculum body of the speculum of  FIG.  6 A ; 
         FIG.  7 B  is a rear perspective view of the speculum of  FIG.  6 A ; 
         FIG.  7 C  is a rear view of the speculum of  FIG.  6 A ; 
         FIG.  7 D  is a perspective view of the speculum of  FIG.  6 A ; 
         FIG.  7 E  is an exploded perspective view of certain components of the speculum of  FIG.  6 A ; 
         FIG.  7 F  is an enlarged perspective view of a portion of the speculum of  FIG.  6 A ; 
         FIG.  8 A  is a top view of the dilator of the speculum of  FIG.  6 A ; 
         FIG.  8 B  is a side view of the dilator of the speculum of  FIG.  6 A ; 
         FIG.  8 C  is a rear view of the dilator of the speculum of  FIG.  6 A ; 
         FIGS.  9 A- 9 B  show instructions that may be included in a screening and treatment kit including the speculum of  FIG.  6 A ; 
         FIGS.  10 A- 10 D  show an embodiment of a speculum system in accordance with the present invention including an imaging/data device mount; 
         FIGS.  11 A- 11 C  show another embodiment of a speculum system in accordance with the present invention including an imaging/data device mount; 
         FIGS.  12 A- 12 B  show a still further embodiment of a speculum system in accordance with the present invention including an imaging/data device mount; 
         FIG.  13    shows a speculum system in accordance with the present invention including a data network architecture; 
         FIGS.  14 A- 14 C  show a speculum system in accordance with the present invention including a smoke evacuation tube mount; 
         FIG.  15    shows a speculum dilator with an accessory channel in accordance with the present invention; and 
         FIGS.  16 A- 16 B  show accessory mounts for a speculum system in accordance with the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     In the following description, the invention is set forth with respect certain specific embodiments of vaginal specula and associated structure and equipment, as well as related functionality and processing. While these embodiments illustrate the principles of the present invention, it is anticipated that further embodiments of the invention are possible and will be apparent to those skilled in the art upon consideration of the present disclosure. Accordingly, the invention is not limited to the embodiments as set forth herein. 
     In the following description, various embodiments of the inventive speculum are first described. Thereafter, certain structure and functionality are described for facilitating mounting of auxiliary equipment on the inventive speculum, for example, for imaging and other medical procedures. 
     Speculum Embodiments 
       FIGS.  1 A  and B illustrate perspective views of a speculum  100  in accordance with the present invention. Specifically,  FIG.  1 A  illustrates the speculum  100  in contracted or closed configuration and  FIG.  1 B  illustrates the speculum  100  in a dilated or open configuration. The speculum  100  includes a handle  102  for gripping by a physician or other user, a petal assembly  104  for dilating and retaining the vaginal walls of the patient so as to facilitate visual inspection of the uterine walls and cervix as well as associated medical procedures, and a dilator  106  for use in introducing the petal assembly  104  into the patient and for forcing the petal assembly  104  to the expanded configuration as shown in  FIG.  1 B . Withdrawing the dilator  106  from the petal assembly  104  allows the petal assembly  104  to return to the contracted configuration as shown in  FIG.  1 A . 
     The illustrated petal assembly  104  includes a number of petals  107 . As will described in more detail below, at the distal end  108  of the petal assembly  104 , remote from the handle  102 , the petals  107  can spread apart from one another so as to define the dilated configuration and can come back together in order to define the contracted configuration. The petal assembly  104  preferably includes at least three petals  107  to allow expansion with respect to at least two axes or two dimensions, e.g., the Y and Z dimensions as shown in  FIGS.  1 A and  1 B  where the X, Y and Z axes are mutually orthogonal and the X axis is aligned with the longitudinal axis  110  of the petal assembly  104 . The illustrated petal assembly  104  includes four petals  107  each of which extends about approximately one quarter or 90° of the periphery of the petal assembly  104  at the distal end  108  in the contracted configuration. The petals  107  may alternatively overlap or remain somewhat separated (e.g., to avoid pinching) in the contracted configuration. 
     The petal assembly  104  has a generally hollow, truncated conical or bullet-shaped configuration. In the contracted configuration as shown in  FIG.  1 A , the petal assembly  104  has a diameter, D 1 , at the proximal end  112 , thereof, adjacent the handle  102  of about two inches and a diameter, D 2 , at the distal end thereof about 0.75 inches. In the expanded configuration as shown in  FIG.  1 B , the diameter D 2  is, for example, about 1.5 inches. The illustrated petal assembly  104  further includes finger grips  114  that may be gripped by the physician or other user to facilitate insertion of the dilator  106  as will be described in more detail below. In the illustrated embodiment, as in the embodiments described below, the petal assembly  104  as well as the handle  102  and/or dilator  106  may be formed from a clear plastic resin, other plastic or metal. In this regard, plastic or resin materials allow for low cost construction as may be desired for single use disposable applications. The speculum  100  may be constructed from metal materials to allow for sterilization and reused if desired. In the illustrated embodiment, the petal assembly  104  is formed from a clear plastic resin. 
     For example, the body of the petal assembly  104  may be constructed by obtaining or molding the plastic resin in generally cylinderal or conical shape. The plastic resin can then be cut or slit from the distal end toward the proximate end  112  to define the petals  107 . Alternatively, the petals  107  may be formed by appropriate molding. In any event, the petals  107  in the illustrated embodiment do not extend the full length of the petal assembly  104 . Rather, the petals  107  come together at a location near the proximal end  112  to form a continuous cylinderal side wall. In this manner, the petals  107  flex outwardly to the expanded configuration when the dilator  106  is advanced into the hollow interior of petal assembly  104  from the proximal end  112 . When the dilator is withdrawn from the hollow interior of the petal assembly  104 , the petals  107  collapse to the contracted configuration, e.g., due to material memory of the clear plastic resin material or forces exerted on the exterior of the petal assembly  104  by the vaginal walls of the patient or by the user. Where metal materials are utilized, the petal assembly  104  can move between the expanded and the contracted configurations by flexing of the metal materials or by hinge mechanisms. 
     As noted above, the dilator  106  may be formed from plastic, metal or other materials. In the illustrated embodiment, the dilator is formed from a clear plastic resin material. The dilator  106  may have a generally cylindrical or conical configuration and is dimensioned to be received within the hollow interior of the petal assembly  104  at the proximal end  112  thereof. That is, the outside diameter of the dilator  106  (at least the proximal end thereof) is slightly smaller than the inside diameter of the petal assembly  104  at the proximal end  112 . For example, the outside diameter of the dilator  106  at its proximal end thereof may be between about 1.5 and 2 inches. 
     The illustrated dilator  106  has a thumb grip  116  extending from the rear surface thereof. The thumb grip  116  can be gripped by the user to advance the dilator  106  into petal assembly  104  and to withdraw the dilator  106  from the petal assembly  104 . In the illustrated embodiment, the dilator  106  includes a rib (not shown) extending from the bottom of the dilator  106 . This rib and/or the bottom of thump grip  116  runs in a longitudinal dilator track  118  formed in an outer surface of the handle  102  so as to guide the longitudinal movement of the dilator  106 . The thumb grip  116  may be ergonomically shaped and textured so as to facilitate operation by a physician or other user. In the case of a conical dilator  106  can be inserted, distal end first, into the petal assembly  104  to facilitate introduction of the petal assembly  104  into the introitus. The dilator can then be flipped and reinserted into the petal assembly  104  proximal (fat) end first to expand the petal assembly  104  to the extent desired. In the case of a cylindrical dilator  106 , the dilator  106  would be advanced into the petal assembly  104  only after the petal assembly  104  is positioned within the introitus. In such cases, the petal assembly  104  may be bullet-shaped to better resist petal separation during introduction. In this regard, a cylindrical dilator  106  may facilitate better visualization as it provides a wide aperture across its entire length. The dilator  106  may be advanced linearly (and may thereafter maintain its position by friction or a ratchet mechanism) or may be threaded so as to advance into the petal assembly  104  via a rotary, screw-like motion. 
     The illustrated speculum  100  also includes a latex sleeve  120  to protect against penetration of the vaginal walls between the petals and potential pinching. As can be seen in  FIG.  1 B , the petals  107  are separated from one another by spaces in the expanded configuration. As the petals  107  collapse to the contracted configuration, the edges of the petals come together creating a risk that of tissue of a patient will be captured therebetween and pinched. This risk can be reduced by use of the optional latex sleeve  120 . The latex sleeve  120  can be placed over the petal assembly  104  at one end thereof and unrolled like a condom to extend around substantially the entire external surface of the petal assembly  104 . In this manner, the latex sleeve  120  guards against collapsing of the patient&#39;s uterine wall tissue into the spaces between the petals  107 . 
     The handle  102  of the illustrated embodiment has a generally cylindrical configuration. If desired, the exterior surface of the handle  102  may be formed for improved ergonomics. The illustrated handle  102  has a hollow interior cylinder receptacle  122  dimensioned to receive a light source. The light source can be activated by the user to transmit light through the handle  102  and through the petal assembly  104  so as to illuminate a procedure site such as the patient&#39;s uterine walls and/or cervix. In the illustrated embodiment a light pipe  124  is formed in a portion of the petal assembly  104  to guide light to and concrete light on the procedure site. Conventional vaginal specula typically require an expensive custom light source. Though such light sources can be provided in connection with illustrated speculum  100 , the illustrated speculum  100  can also be designed to receive an inexpensive pen light within the cylinder receptacle  122 . The cylinder receptacle  122  may be formed so that the pen light is turned on, e.g., by depressing a button on the pen light, when the pen light is inserted into the cylinder receptacle  122 . Alternatively, the pen light may have an on/off button exposed at a rear end thereof that can be accessed by the user after the pen light is inserted into cylinder receptacle  122 . 
       FIGS.  2 A and  2 B  illustrate a speculum  200 , generally similar in construction to the speculum  100  of  FIGS.  1 A and  1 B  but with a slightly different configuration, for use on a patient. Specifically, in use, the speculum  200  can be introduced into the introitus of the patient in a contracted configuration as shown in  FIG.  2 A . As shown, the speculum  200  is advanced into the patient until the distal end of the speculum  200  is adjacent to the patient&#39;s cervix  201 . It will be appreciated that the speculum  200  is dimensioned appropriately in this regard. For example, the petal assembly  203  may have a length of about 6.5 inches and the handle  205  may have a length of about 3.5 inches for an overall speculum length of about 10 inches. Such dimensions are believed to accommodate a substantial range of physiological variability among patients. Once the speculum  200  has been inserted to the full extent desired, the physician or other user can advance the dilator  207  into the proximal end of the petal assembly  203  so that the petals of the petal assembly are radially separated. 
     It will be appreciated, that, in the case of a four petal assembly as described in connection with  FIGS.  1 A and  1 B , two of the petals may separate along a front to back axis with respect to the patient and two of the petals may separate along a side to side axis with respect to the patient. This creates an unobstructed view. The petals may be formed to separate along other axes if desired. The user can then insert or otherwise activate a light source at the speculum handle  205  to illuminate the uterine walls and cervix of the patient. The physician or other user can then visually inspect the uterine walls and cervix of the patient by looking through the hollow interior of the dilator  207  and petal assembly  203  to obtain a clear view of the procedure site. When the inspection or any other desired procedure (e.g., obtaining an analysis sample by introducing an instrument through the hollow interior of the speculum) is complete, the dilator  207  is withdrawn from the petal assembly  203  allowing the petal assembly  203  to collapse to the contracted configuration. The speculum  200  can then be withdrawn from the patient&#39;s introitus and disposed of and or sterilized as appropriate. 
       FIGS.  3 A- 3 G  illustrates a speculum  300  constructed in accordance with alternative embodiment of the present invention. The speculum  300  generally includes a petal assembly  302  a handle  304  including a receptacle  306  for holding a light source  308  and a ratchet assembly  310  for use in expanding the petal assembly  302 . The ratchet assembly  310  is operated using a thumb lever  312 . 
     The speculum  300  of  FIGS.  3 A- 3 E  shares many characteristics with the speculum of  FIGS.  1 A and  1 B . For example, the speculum  300  is used by inserting the petal assembly  302  into the patient&#39;s introitus with the speculum  300  in a contracted configuration (as shown in  FIGS.  3 B and  3 C ). The speculum  300  is then expanded to the dilated configuration (as shown in  FIGS.  3 A and  3 D ). The light source  308  can then be activated to illuminate patient&#39;s vaginal walls and cervix which can be inspected visually by looking through the hollow petal assembly  302 . Moreover, like the embodiment of  FIGS.  1 A and  1 B , the speculum  300  expands radially with respect to multiple axes for improved viewing without interference due to collapsing vaginal walls. 
     However, the speculum  300  has some differences in relation to the embodiment of  FIGS.  1 A and  1 B . In particular, whereas the petals in  FIGS.  1 A and  1 B  are separated by spaces at least in the expanded configuration, the petals  314  of the speculum  300  overlap as can best be seen in  FIGS.  3 E and  3 G . When the petal assembly  302  is expanded or contracted, the petals slide circumferentially over one another (as generally indicated by arrows  305 ) in manner analogous to a collapsible colander. Accordingly, there are no spaces between the petals in either the expanded contracted configuration. This may further protect against collapsing of the vaginal walls and potential pinching. 
     Another difference between the illustrated speculum  300  and that of  FIGS.  1 A and  1 B  is the mechanism for actuating expansion of the petal assembly  302 . Specifically, the petal assembly  302  is expanded by operation of the thumb lever  312 . The thumb lever  312  interfaces with a worm gear ratchet as shown in  FIG.  3 F  such that depressing the thumb lever closes the speculum  300  to the contracted configuration and pulling outwardly on the thumb lever  312  causes the speculum  300  to be expanded to the dilated configuration. The thumb lever  312  causes the worm gear of ratchet assembly  316  to rotate. The worm gear ratchet assembly  316  is then connected to the proximal ends  313  of the petals  314  by appropriate linkage (as shown in  FIGS.  3 F and  3 G ) to expand and contract the petal assembly  302  as desired. 
     The illustrated speculum  300  is dimensioned to accommodate a range of patients including larger patients. For example, the diameter D 1 , of the proximal end of the petal assembly  302  may be about 1.5 inches. The diameter, D 2 , of the distal end of the petal assembly may be about 1.4 inches in the expanded configuration and about 0.7 inches in the contracted configuration. The petal assembly  302  has a length, L 1 , of about 6.5 inches and the handle  304  has a length, L 2 , of about 3.5 inches for an overall length, L 3 , of about 10 inches for the speculum  300 . 
       FIGS.  4 A- 4 E  illustrate a still further embodiment of a speculum  400  in accordance with the present invention. The speculum  400  includes a number of overlapping speculum petals  402  generally similar to the petals in the embodiment of the  FIGS.  3 A- 3 G . In this case, however, the petals are expanded and contracted directly by rotating retention ring  404  rather than using a ratchet assembly as described in connection with the embodiment of  FIGS.  3 A- 3 G . In addition, the handle  406  is offset vertically, by offset structure  407 , from the expansion assembly  408  which may facilitate visual inspection through the expansion assembly  408 . The handle  406  further includes a receptacle  410  for receiving a light source and a light pipe  412  for directing light from the source to the patient&#39;s cervix. 
       FIGS.  5 A- 5 F  illustrate a speculum  500  in accordance with a still further embodiment of the present invention. The speculum  500  is similar to the speculum  100  of  FIGS.  1 A- 1 B , with some additional features shown and minor differences in configuration. The speculum  500  generally includes: a generally conical petal assembly  502  including a number of petals  504 ; a generally cylindrical dilator  506  for expanding the petal assembly  502  and allowing it to contract; and a handle  508  including a receptacle  510  for receiving a light source  512 . As discussed above, the speculum can be formed, for example, from clear plastic or metal as desired. 
     The illustrated petals  504  are formed in an overlapping, collapsible configuration. That is, adjacent petals  504  extend circumferentially over one another, and slide over one another as the petal assembly  502  is expanded and contracted. In this manner, gaps between the petals  504  are avoided, even in the expanded configuration, thus reducing the likelihood that tissue of the patient will be pinched due to operation of the speculum  500 . 
     The speculum  500  further includes a ratchet mechanism  514  for advancing and withdrawing the dilator  506  into and out of the petal assembly  502 . The ratchet mechanism  514  includes a ratcheted handle surface  516  that interfaces with a bottom of a thumb lever  518 . The thumb lever  518  includes an advance surface  520  and a release surface  522 . The physician or other user can press on the advance surface  520 , as generally indicated by arrow  524 , to move the thumb lever  518  forward. The thumb lever  518  presses against the dilator  506  so that it also moves forward thus expanding the petal assembly  502 . The ratchet mechanism  514  is then effective to hold the speculum in the expanded configuration. 
     To release the ratchet mechanism  514  so that the dilator  506  can be withdrawn from the petal assembly  502  to close the petals  504 , the user can press on the release surface  522  as generally indicated by arrow  526 . This causes the rear edge of the thumb lever  578  to lift and disengages the ratchet mechanism  514 . The user can then slide the thumb lever  518  rearwardly to withdraw the dilator  506  from the petal assembly  502 . 
     As noted above, the handle  508  includes a receptacle  510  for receiving a light source  512 . Although any appropriate light source can be used, the illustrated receptacle  510  can receive a low-cost pen light type of light source  512 , thereby reducing costs and inconvenience in relation to some conventional systems. The light source  512  may have an on/off button at its rear end that can be easily accessed by the user during a procedure. Light from the light source is guided through the handle  508 , and directed through the petal assembly  502  to the procedure site by a plastic light pipe  528 . Optionally, a brightly colored tag  530  or strap may be attached to the light source  512  to assist in locating the light source and to remind the user not to accidentally dispose of the light source  512  when the speculum  500  is discarded after a single use. 
     The petals  504  of the illustrated speculum  500  overlap, as indicated by arrow  532 , so that there are substantially no spaces between the petals  504  in the dilated configuration. In this regard, the petals  504  may move linearly (or arcuately with substantially no circumferential component) in a radial direction when expanding while maintaining their overlapped, stacked relationship at their proximal ends like flower petals, or the petals  504  may slide circumferentially over one another while expanding like an expandable colander. 
     The speculum  500  is preferably dimensioned to accommodate a range of patients. For example, the petal assembly  502  may have a length L 1 , of about 3.5 inches and the handle  508  may have a length, L 2 , of about 3.5 inches for an overall speculum length of 7 inches. In the contracted configuration, the distal end of the petal assembly  502  has a diameter, D 1 , of about 1.5 inches. The distal end of the petal assembly  502  preferably has a bullet-shaped configuration, as can be seen in  FIG.  5 E , that helps maintain the petal assembly  502  in the contracted configuration as the petal assembly  502  is introduced into the introitus. Optionally, one or more pegs  534  and mating receptacles may be provided at the distal end of the petal assembly  502  to further assist in maintaining the contracted configuration. 
     In the various embodiments disclosed above, the handles generally extend rearwardly in alignment with or at an acute angle to the longitudinal axis of the petal assembly in each case. 
     Another embodiment of a speculum  600  in accordance with the present invention is shown in  FIGS.  6 A- 9 B . The speculum  600  generally includes a speculum body  602  and a dilator  604 . The speculum body  602 , in turn, includes a petal assembly  606  and a handle  608 . 
       FIG.  6 A  shows the speculum  600  in a retracted configuration and  FIG.  6 B  shows the speculum  600  in a dilated configuration. The speculum  600  is moved between the retracted and dilated configurations by advancing or withdrawing the dilator  604  relative to the speculum body  602  along the longitudinal axis  610  of the speculum  600 . In the fully inserted position of the dilator  604 , corresponding to the fully dilated configuration of the speculum  600 , the collar  614  of dilator  604  buts against the rear surface  616  of the speculum body  602 . The dilator  604  also includes ratchet teeth  618  that allow the dilator  604  to be positioned in various intermediate positions between the fully inserted and fully retracted positions. Such intermediate positions may be preferred depending, among other things, on the anatomy of the patient and the procedure being performed. 
     In operation, a user, who may be a physician, physician&#39;s assistant, clinic staff member or other person, can insert a light source  607  ( FIG.  9 B ) into the handle  608 , as will be described in more detail below, and turned the light source on. A sheath formed from latex or other suitable material may be applied around the forward end of the speculum  600 , if desired, and a lubricant may be applied to the sheath or forward end. The user can then grip the speculum  600  using the handle  608  and advance the forward end  620  of the speculum  620  into the patient and advance the speculum  600  until the speculum  600  meets resistance. At that point, the user may press against the rear flange  622  of the dilator  604 , for example, using the thumb of the same hand that grips the handle  608  or the user&#39;s other hand, and advances the dilator  604  in relation to the speculum body  602  to the desired position. Various procedures can then be performed as will be discussed in more detail below. At the conclusion of the procedure or procedures, the user can depress the ratchet release lever  624 , for example, using the thumb of the same hand that grips the handle  608  or the user&#39;s other hand, allowing the dilator  604  to be withdrawn from the speculum body  602  to reach the fully retracted configuration. The speculum  600  can then be readily withdrawn from the patient. 
     The handle  608  of the illustrated speculum  600  is angled in relation to the petal assembly  606 . More specifically, the handle  608  is oriented such that an angle, θ, that is less than 90°, is defined between the longitudinal axis  612  of the handle  608  in relation to the longitudinal axis  610  of the speculum  600  and petal assembly  606 . Conventional specula have handles that are oriented perpendicular to the longitudinal axis of the speculum. This is customary and works well when the patient is reclined on an appropriate examination table. However, in many cases, including clinics in geographies where medical resources may be more limited, such an examination table may not be available. Moreover, the illustrated angled configuration facilitates convenient access to the dilator  604 . At the same time, the angled configuration positions the user&#39;s hand on the handle  608  outside of a line of viewing and access to the patient generally corresponding to the longitudinal axis  610 . It is noted that some of these considerations can alternatively be addressed by providing a handle that is generally aligned with the longitudinal axis of the speculum but is offset from the longitudinal axis of the speculum by depending structure extending between the handle and the speculum body as generally shown above. 
     In the illustrated embodiment, the angle, θ, is less than 75°. More preferably, the angle is between about 30°-75°. Most preferably, the angle is between about 40°-60°. In the illustrated embodiment, the angle is about 50°. 
       FIG.  7 A- 7 E  show various views of the speculum body  602 . More specifically,  FIGS.  7 A- 7 C  show the speculum body  602  alone in order to better illustrate certain features whereas  FIG.  7 D  shows the full speculum  600  including the speculum body  602  and the dilator  604 .  FIG.  7 E  shows an expanded view of certain portions of the speculum body  602 . As shown, the speculum body  602  includes the petal assembly  606  and the handle  608 . The petal assembly  606  includes a number of petals  626 . The number of petals  626  may vary, but the assembly  606  will generally include at least three petals  626  so as to allow for dilation relative to more than one axis for improved treatment site visualization and access. The assembly  606  may have many petals with the upper limit being determined by practical considerations such as ensuring that each petal  626  is sufficiently strong or stiff so as not to collapse under pressure from the vaginal walls. This will depend on a number of factors including materials, any stiffening structure formed in the petals  626 , and the amount of support provided by the dilator  604  when inserted into the assembly  606 . In the illustrated embodiment, five petals  626  are provided in the petal assembly  606 . 
     At the forward end  620  of the assembly  606 , each of the petals  626  is rounded and turned inwardly toward a centerline (generally corresponding to the axis  610  of  FIGS.  6 A- 6 B ) so as to define a blunt nose shape to the forward end  620  for improved penetration and patient comfort. The petals  626  are separated by slots  628 . The slots  628  are shaped such that the edges of adjacent petals  626  are substantially abutting when the petal assembly  606  is in the fully retracted position. In this manner, the risk of pinching during insertion and withdrawal is reduced. The edges of the petals  626  may also be slightly rounded or otherwise shaped so as to reduce pinching during transition from the dilated configuration to the retracted configuration of the assembly  606 . In addition, as shown, the base  630  of each of the slots  628  may be rounded so as to eliminate stress points and potential cracking of the speculum body structure. 
     As noted above, the petals  626  are turned inwardly at the front end  620  to define a blunt nose shape. Specifically, the petals  626  may turn inwardly over the last 0.25 inches adjacent the tips of the petals  626 . At the start of this turn, the front end may have a diameter d 1  ( FIG.  7 A ), of no more than about 0.75 inches, for example, about 0.5 inches, in the contracted configuration, and a diameter, d 2  ( FIG.  6 B ), of at least 1.5 inches, for example, about 1.75 inches, in the dilated configuration. 
     In addition, the length of the handle  608  may be between about 3-6 inches, for example, between 4-5 inches. In the illustrated embodiment, the handle is about 4.25 inches. At least the external surface of the handle base  640  may include ribs or other contouring for improved gripping and ergonomics. The overall length of the petal assembly  606  may be between about 4-7 inches, for example, between about 5-6 inches. The illustrated assembly is about 5.5 inches long. The individual blades  626  may be between about 4-5 inches, for example, about 4.5 inches. The illustrated blades have a maximum width of about 0.8-0.9 inches. The thickness of the plastic forming the speculum  600  may be about 0.06-0.15 inches with the thickness varying, e.g., to define flex points. 
     The overall length of the dilator  604  may be between about 4-7 inches, for example, between about 5-6 inches. The illustrated dilator is about 5.25 inches long. The length from the collar  614  to the front end of the dilator  604  may be between about 4-5 inches, for example, about 4.5 inches. The diameter of the dilator  604  is selected to extend within and expand the blade assembly  606 . As noted above, the diameter of the dilator  604  may taper over at least a front section thereof. In the illustrated embodiment, the inside diameter of the dilator  604  at the back end may be about 1.5-1.6 inches and the inside diameter at the front end may be about 1.1-1.2 inches. While the noted dimensions are believed to be suitable to accommodate a large range of patients, the speculum  600  may be provided in other sizes, e.g., for young or small patients (or larger patients). 
     The petal assembly  606  is connected to the handle  608  via a reinforced central section  634 . Hinge portions  632  may be defined where each of the petals  626  meets the central section  634 . In the illustrated embodiment, the speculum body  602  is formed from molded plastic. The hinge portion  632  is provided at a narrowed area of each of the petals  626  corresponding to the widened base  630  of the slots  628 . The thickness of the plastic may be slightly reduced at the hinge portion  632  to define a fabric hinge. The fabric hinge  632  thus defines the principal location of flexion associated with moving between the dilated and retracted configurations of the assembly  606 . More specifically, when the dilator  604  is advanced forwardly so that the forward edge of the dilator  604  extends beyond the hinge portion  632  the dilator  604  begins to press outwardly against the inner surfaces of the petals  626  causing the petals  626  to flex outwardly at the hinge portion  632 . 
     As best seen in  FIG.  7 D , the handle  608  has a generally U-shaped cross-section defined by a base  640  and sidewalls  642  with an open top  644 . A light source receptacle  646  is provided in the interior area of the handle  608 . The receptacle  646  is defined by receptacle walls  648  and  650 . The walls  648  and  650  are generally parallel and are otherwise configured to receive a light source, such as a penlight, therebetween. In this regard, the walls define a receptacle that has a width, w, and a height, h, selected to securely receive a cylindrical penlight therein. The particular dimensions may be selected to accommodate the desired penlight. In this regard, penlights are typically generally cylindrical in shape and have a diameter selected to securely hold a AAA battery that is often used as a power source. As the AAA battery has a diameter of 0.41 inches, the penlight diameter is generally slightly larger. In the illustrated embodiment, the width, w, of the receptacle and the height, h, of the receptacle are each about 0.4-0.6 inches, for example, about 0.47 inches. The length of the receptacle is about 3-4 inches. The receptacle  646  thus accommodates a variety of penlights that are commercially available including penlights having a diameter of between about 0.45-0.6 inches and a length of between about 3-6 inches. 
     Each of the walls  648  and  650  further includes continuous or intermittent retaining members  645  for retaining the light source in the receptacle  646 . The members  645  are disposed adjacent the upper ends of the walls  648  and  650  away from the base  640  of the handle  608 , and extend slightly inwardly toward the center of the receptacle  646  and towards the opposing wall. The plastic walls  648  and  650  can flex sufficiently to allow the light source to be inserted into the receptacle  646  via the open top  644  of the handle  608  such that the light source snaps into place in the receptacle. Alternatively, the light source can be inserted into the receptacle  646  longitudinally by sliding the light source along the length of the receptacle  646 . 
     The open top configuration of the handle  608  and receptacle  646  also allows access to on/off switches of light sources that are located on the rear end of the light source or on a side surface of the light source thus providing additional flexibility in selecting a light source, e.g., to reduce costs. A stop  652  at the forward end of the receptacle  646  defines the forwardmost position of the light source in the receptacle  646 . In this manner, the sidewalls  648  and  650  together with the stop  652  ensure proper positioning of the light source so that the light source is aligned as desired with the light directing block  656  as will be described in more detail below. In this regard, the stop  652  extends upwardly from the base  640  of the handle  608  sufficiently to engage and stop the light source but without blocking light from the light source. The illustrated stop  652  has a generally semicircular cross-section and is received within a correspondingly shaped recess  653  formed in the base  640  of the handle  608 . 
     The central section  634  connects the handle  608  to the petal assembly  626 , serves as a mounting structure for various elements as will be described below, and receives the dilator  604 . Accordingly, the central section  634  will bear substantial forces in operation and needs to be sufficiently strong and stiff. In this regard, the central section  634  may be formed from stronger materials, may be thicker, may be structurally reinforced, or otherwise provided with sufficient strength to perform the noted functions. In the illustrated embodiment, the central section  634  is formed from inner  636  and outer  638  members that collectively thicken and reinforce the central section  634  as well as simplifying manufacturing. The inner member  636  and outer member  638  include complementary tongue and groove connections  657  that allow for convenient sliding interconnection as well as proper alignment and orientation of the members  636  and  638 . A groove  658  formed in the inner member  636  receives the ratcheting teeth  618  ( FIG.  6 A ) of the dilator  604  and a recess  660  formed in the groove  658  allows each tooth  618  to register and lock into position. For example, the teeth  618  may be spaced so as to correspond to 0.125-0.25 inch measurements in dilation diameter of the petal assembly  606 . The inner member  636  and outer member  638  also have slots formed therein for receiving the light directing block  656  including the dilator retaining guides  654  as will be described in more detail below. 
       FIG.  7 E  shows expanded perspective views of the light directing block  656  and the stop  652 . Although these components are illustrated as separate pieces, the block  656  and stop  652  may be formed as a single integral unit or both the block  656  and stop  652  may be integrally formed (e.g., molded) as part of the speculum housing  602 . In the illustrated implementation, the block  656  is provided as a separate molded plastic piece that is placed in position and fused or bonded to the base of the central portion  634  of the speculum housing  602 . Similarly, the illustrated stop  652  is provided as a separate molded plastic piece that can be received in the channel  653  of the handle  608  and can then slide forward in the channel until it abuts the bottom of the block  656 . The stop  652  can then be fused or bonded in the desired position. 
     The illustrated block  656  includes stop retaining guides  654 . As will be understood from the description below, the guides  654  extend through a slot formed on the bottom surface of the dilator to guide the sliding motion of the dilator  604  through the petal assembly  606 . In addition, the front surfaces of the guides  654  abut against the rear surface of the slot formed in the dilator  604  to define the forwardmost position of the dilator  604  with respect to the petal assembly  606 . The forward surface of the guides  654  also abut against the forwardmost end of the slot formed in the dilator  604  to define the fully retracted position of the dilator  604  with respect to the petal assembly  606  and to prevent inadvertent separation of the dilator  604  from the speculum body  602 . 
     When the light source is placed in the receptacle  646  and turned on, light passes above the upper surface of the stop  652  generally in the direction indicated by arrow  657  and is incident on a bottom surface of the guide  656 . If desired, a face may be molded into the bottom surface of the guide  656  and oriented normal (or in another desired orientation) to the direction of the light  657 . Through processes of refraction, diffusion and/or internal reflection, light exits the forwardmost surfaces of the block  656  and guides  654  generally in the direction indicated by arrow  659 . When a standard LED penlight is used as the light source, it has been found that this light, together with other light that illuminates the speculum body  602  and dilator  604 , is sufficient to illuminate the procedure site at the front end of the speculum  600 . The direction  659  of the exiting light is thus generally aligned with the longitudinal axis of the speculum  600 . 
       FIGS.  8 A- 8 C  show various views of the dilator  604 . Like the other parts of the speculum  600 , the dilator  604  may be formed from molded transparent plastic. As shown, the dilator  604  is slightly tapered from its rear end  662  its forward end  662 . This shape better matches the shape of the inner surfaces of the petal assembly  606 , facilitates insertion of the dilator  604  into the petal assembly  606  and supports the petal assembly  606  under pressure from the vaginal walls in the dilated configuration. The speculum  600  may be provided in different sizes and shapes in this regard to accommodate different patients, e.g., different ages or different sizes. 
     As noted above, the dilator  604  includes a thumb flange at the rear end  660  thereof that the user can press to advance the dilator  604 . The dilator  604  also includes a collar to limit forward movement of the dilator  604  relative to the speculum body  602 . The ratchet teeth  618  are formed on a cantilevered lever defined by slots  666 . The cantilevered lever  664  is sufficiently flexible that the lever  664  can be depressed by pressing on the finger grip  668  so as to release the teeth  618  from the recess  660 . In this manner, the dilator  604  can be readily withdrawn from the speculum housing  602  and the dilator  604  can be advanced into the speculum body  602  to a desired position without a clicking sound that may be distracting to some patients. The forward ends of the slots  666  flare outwardly slightly from a centerline of the dilator  604  to reduce any structural weakness associated with a single flexion point of the cantilevered portion  664 . The bottom surface of the dilator  604  includes an elongate slot  668 . The slot  668  receives the guides  654  ( FIG.  7 F ) and allows for controlled sliding of the dilator  604  in relation to the speculum housing  602 . A stop  670  is provided at the forward end of the slot  668  to define the fully retracted position of the dilator  604  in relation to the speculum body  602  and to inhibit inadvertent separation of the dilator  604  from the speculum body  602 . The stop  670  is sized, in conjunction with the tapered shape of the dilator  604 , to enable separation of the dilator  604  from the speculum body  602  when desired and re-insertion thereof. 
     The inventive speculum as described above is believed to provide a number of performance advantages in relation to conventional specula. For example, the inventive speculum is believed to provide improved visualization and access to the cervix as well as improved support of the vaginal walls so as to prevent collapsing into the field of view. For example, the multiple petal design and the configuration of the forward petal ends tends to allow for improved access. 
     The inventive speculum also has potential cost advantages. In this regard, the speculum is of simple and inexpensive construction. In addition, the speculum can be used with an off-the-shelf penlight rather than expensive, custom light sources as sometimes required in connection with conventional specula. Moreover, the configuration of the inventive speculum enables use of the speculum even where custom examination tables are not available. 
     These potential cost advantages, together with certain other cost-effective measures as described below, allow for the possibility of providing a low cost kit for cervical screening and treatment. Such a kit may be provided in one or more containers that include the principal components needed for cervical screening and treatment. For example, components of the kit deemed to be single use components may be provided in a single sealed container such as a sealed plastic bag. Other components that may be deemed suitable for re-use may be provided in a second container or separately. As a practical matter, this may greatly increase the number of women worldwide who are able to receive screening and treatment and has the potential to dramatically reduce deaths from cervical cancer. 
     One of the components that may be included in such a kit is a simple set of instructions. An example of what such a set of instructions may look like is shown in  FIGS.  9 A- 9 B  which also provide a convenient set of illustrations for describing the kit. Referring to  FIG.  9 A , the first panel of the instructions for screening and treating for cervical cancer shows an example of components that may be included in a kit. The illustrated components include a speculum, surgical gloves, a container of lubricant, a container of a visualization aid, applicators, and a compressed gas container. The use of each of these components will be further explained in the instructions. All of the components shown in the first frame may be included in a single sealed container to provide a relatively inexpensive, self-contained kit for a single procedure. Alternatively, certain components that may be used for more than one procedure, for example, the can of compressed air, the lubricant, and the visualization aid container, may be provided separately such that the kit is defined by multiple kit containers. 
     As shown in the second panel of the instructions, the user may then snap a penlight (provided as part of the speculum or provided separately as part of the kit) into the handle of the speculum and can turn the penlight on. Panel three instructs the user to apply lubricant to the speculum, e.g., to a latex sleeve extending around the forward end of the petals or directly to the petals. The entire speculum can then be advanced into the patient until resistance is met as shown in panel four. Once the speculum is thus positioned, the user can advance the dilator to dilate the petal assembly to the desired configuration as shown in panel five. Panel six illustrates use of an applicator to apply a visualization agent to the cervix by inserting the applicator through the hollow center of the speculum. Although the instructions indicate that the visualization agent is dilute acetic acid, iodine or other visualization aids are possible. 
     Referring to  FIG.  9 B , the instructions proceed with panel seven. Panel seven instructs that, after 45 seconds, the cervix may be observed for any acetowhite lesions. Panel eight provides a depiction of precancerous lesions and cancer of the cervix as well as a normal cervix. Panels nine and ten illustrate a convenient and cost-effective treatment for white lesions. In particular, such lesions may be treated by cryoablation which induces a response in healthy patients that may prevent progression to cancer. In this case, a can of compressed gas is used such as compressed gas cans typically used to remove dust from electronic equipment. Such cans typically include difluoroethane, trifluoroethane or tetrafluoroethene. While these products are marketed as compressed gas containers, the cans generally contain gases that are compressible into liquids. When the can is used in an upright position, high-pressure gas is emitted from the nozzle upon depressing the nozzle and the gas can be precisely directed to the desired location via an elongate tube connected to the nozzle. However, if the can is inverted, a liquid or gas liquid mix may be dispensed. This fluid is dispensed at a very low temperature that, subject to approval or control by a physician where required, may be applied to the lesions for cryoablation treatment. 
     Thus, panel nine of the instructions directs the user to turn the bottle upside down and spray the tip of the applicator. The applicator can then be inserted through the speculum as shown in panel  10  to apply the cold treatment to the lesions. When treatment is complete, the user can press down on the finger grip of the cantilevered portion of the speculum to withdraw the dilator from the speculum body as shown in panel eleven. The speculum can then be withdrawn from the patient. Panel twelve instructs the user to dispose of the speculum while retaining the penlight for future use. 
     Mounting Structure 
     As noted above, a variety of equipment and procedures may be used in conjunction with a speculum. This may involve imaging the cervix, processing images of the cervix for screening or diagnosis, and implementing transvaginal procedures for diagnosis or treatment. In this regard, it may be useful to mount certain equipment or components in relation to the speculum for simplified handling. Such equipment may include, for example, imaging systems or components thereof, medical equipment, or smoke evacuation systems or components thereof as will be described in more detail below. 
     In certain cases, it is desirable to obtain an image of the subject&#39;s cervix. For example, such images may be obtained to provide a baseline image for later comparison or a real-time image for analysis of a condition of interest, e.g., a lesion, discoloration, anomaly or other suspicious cervix condition or other condition. In this regard, a digital image of the subject&#39;s cervix may be obtained for digital analysis and/or analysis by a physician, technician, or other analysts. Such analysis may be conducted locally, e.g., on a display screen at the procedure site, or remotely by transmitting one or more images from the procedure site to a remote data terminal, e.g., a phone, tablet computer, desktop computer, or medical image processing system. It will be appreciated that such remote viewing enables convenient access to remote sources and expertise. Moreover, in the case of underserved communities, such remote review can potentially provide access to services that were previously unavailable or impractical. 
     The present invention facilitates acquisition of digital images as well as transmission of such images via a data network, e.g., the Internet, and remote review and analysis. The invention enables this functionality for modern medical facilities as well as less equipped facilities and even temporary field sites for underserved populations. 
     Currently, the gold standard for imaging a subject&#39;s cervix is colposcope imaging. Colposcopes come in a variety of forms. One common form is typically implemented as multiple pieces of equipment mounted on a mobile cart. The equipment includes a binocular viewer/camera mounted on an arm that can be positioned to view the cervix via the central opening of a conventional, two-blade speculum. A display and a control unit are also mounted on the cart. A user can use the viewer to view the cervix and position the camera for obtaining an image. Images are then displayed in real time on the display. In other cases, the camera component is implemented as a hand-held transvaginal probe that is inserted through the central opening of the conventional, two-related speculum imaging. 
     These conventional systems for imaging the cervix have a number of drawbacks. First, such imaging requires expensive and bulky equipment that may be impractical for smaller facilities, and especially temporary field sites for underserved populations. Accordingly, some subjects may not be afforded the opportunity for imaging support. In addition, such systems can be cumbersome to operate as they require simultaneous operation of a speculum and a separate imaging system. It may be difficult for an individual user to properly position the speculum and the imaging system while also operating the imaging system to obtain images is desired. Finally, the systems are typically intended for real-time image analysis, at the imaging site, by a physician skilled in such analysis. While this can provide excellent healthcare service for some women, such services are not available to women in many settings. 
     Accordingly, the present invention includes various embodiments for speculum systems that can interface with imaging systems and data networks for remote image analysis. This includes low-cost, convenient interfaces implemented using, e.g., a smart phone, as well as embodiments that can be implemented in a variety of clinical environments. These speculum systems allow for mounting of imaging system components on a speculum with improved visualization, as described above, so as to enable convenient operation of the speculum system, including by a single user. Moreover, the systems allow for remote analysis by a skilled analyst, with or without image enhancement/digital analysis, to better service women in a variety of clinical/field settings. Finally, the invention makes real-time or nonreal-time image analysis available for many women would otherwise not be able to avail themselves of those services, thus potentially improving health and substantially reducing morbidity and mortality. 
       FIGS.  10 A- 10 D  show a speculum system  1000  in accordance with the present invention. The system  1000  enables a portable imaging/networking device such as a phone  1002  to be mounted on an improved speculum  1012  such as described above. In this manner, users, including users practicing in smaller clinics or temporary field sites, to conveniently obtain high-quality images of a patient&#39;s cervix and to transmit those digital images to a remote analyst for analysis, e.g., via email or other networking functionality. 
     The illustrated system  1000  includes a mounting member  1004 , a first adjustable support assembly  1006 , a second adjustable support assembly  1008 , and an assembly mount  1010 . The mounting member  1004  is configured to snap into the handle  1014  of the speculum  1012 . As discussed above, the speculum  1012  is formed to receive an illumination source such as a penlight in a channel of the handle  1014  so as to illuminate the subject&#39;s cervix. The structure can be used to receive the mounting member  1004 . For example, the mounting member  1004  may be a penlight or a dedicated mounting member  1004  having similar dimensions. 
     The first and second support assemblies  1006  and  1008  are adjustable to receive a variety of devices  1002 . One practical implementation is adapted to support a phone  1002  such as any of various commercially available smart phones. It will be appreciated that this is practical for smaller facilities or field sites as smart phones are readily available, images, and enable convenient data network access. In this regard, the phone can transmit digital images to a remote analyst using email or using an application loaded on the phone for uploading images directly to a facility of the analyst or a platform such as a cloud-based platform as will be discussed in more detail below. 
     The support assemblies  1006  and  1008  may be adjustable to securely hold smart phones of a variety of dimensions. In addition, the assemblies  1006  and  1008  may allow for vertical positioning of the smart phone so that a camera of the smart phone is aligned with an axis of the speculum  1012  to obtain an image of the subject&#39;s cervix. In this regard, the assembly  1006  may include slides or other telescoping mechanisms to enable longitudinal expansion and contraction to engage the sides of the phone  1002 . Similarly, the assembly  1008  may include slides or other telescoping mechanisms to allow the mechanism  1008  to be vertically raised or lowered to position the camera of the device  1002  as desired. 
     The illustrated system  1000  also includes a mount  1010  for mounting the device support assembly  1001  on the mount member  1004 . In the illustrated embodiment, the assembly  1001  is substantially permanently mounted on the member  1004  using bands, zip ties, or other mounting structure. Alternatively, the assembly  1001  may be removably mounted on the member  1004  via a snapping plastic grip or similar mechanism. The assembly  1001  may further include an adjustable joint  1016  for allowing the assembly  1001  to be movable so as to move the device  1002  to a desired position and angle. In this regard, joint  1016  may rotate or pivot and translate or allow for linear motion of the assemblies  1006  and  1008  relative to the mount  1004 . Moreover, as shown in  FIG.  10 D , the joint  1016  also allows the device  1002  two be rotated to a horizontal position to be out of the way, for example, to allow a user to view the cervix or access the cervix for a medical procedure such as cryoablation or sampling. 
       FIGS.  11 A- 11 C  show another embodiment of a speculum system  1100  in accordance with the present invention. The system  1100  includes a speculum  600  that is generally similar to the speculum described above in connection with  FIGS.  6 A- 6 B  and corresponding elements identified by the same reference numerals as in those Figs. However, the illustrated system  1100  further includes a removable imaging system  680  that can be movably mounted on the handle  608 . As shown, the imaging system  680  includes an elongate body  681  and a digital imaging detector  682 . Alternatively, the system  680  may include a fiber optic element connected to a remote detector. Although not shown, the system  680  may further include lenses, filters, fiber optic reducers, or other imaging elements. The body  681  is movably mounted in an elongate slot  684  formed in the handle  608 . For example, the body  681  may include one or more protrusions that are received in an opening  686  at an end of the slot  684 . In this manner, the body  681  and detector  682  can move longitudinally within the slot  684 . 
       FIGS.  11 A- 11 C  show the body in a fully withdrawn position ( FIG.  11 A ), for example, to avoid interfering with viewing or performing medical procedures on the patient&#39;s cervix, a partially inserted position ( FIG.  11 B ), and a fully inserted position ( FIG.  11 C ), for example, for obtaining images of the subject&#39;s cervix. It will be appreciated that the body  681  can extend through an opening formed in the body of the speculum  600  and dilator  604 . For example, such openings may be circular, rectangular, or, in the case of the dilator  604 , an elongate slot to permit movement of the dilator  604  in relation to the body of the speculum  600 . The illustrated system  1100  further includes a cord  688  for supplying power to the imaging system and communicating with a remote system for image processing. It will be appreciated that the image information may be processed locally or remotely via a data network as discussed in more detail below. 
       FIGS.  12 A- 12 B  show a further embodiment of a speculum system  1200  in accordance with the present invention. The illustrated system  1200  includes a speculum  600 , such as described above in connection with  FIGS.  6 A- 6 B , and a colposcope hand-held imaging device  1202 . As shown in  FIG.  12 B , the device  1202  can be longitudinally inserted into the central opening of the speculum  600  to obtain images of the subject&#39;s cervix. In this regard, the illustrated speculum  600  includes a device support  1204  that is hingedly mounted on the handle  608  of the speculum  600  at pivot  1206 . In this manner, the support  1204  is movable between a retracted position, where the support  1204  is withdrawn into the handle  608  and a deployed position, as shown in  FIG.  12 B , where the support  1204  supports the body of the device  1202 . The support  1204  may be securely maintained in the deployed position by a ratchet or locking mechanism among other possibilities. In addition, if desired, a flexible annular support ring may be mounted on a forward portion of the device  1202  to further secure the device  1202  within the dilator of the speculum  600 . It will be appreciated that the system  1200  thus allows a user to conveniently position both the speculum  600  and the device  1202  using the handle  608 . The user&#39;s other hand is thus available to operate light and camera controls  1208  on the device  1202  or for other operations. 
       FIG.  13    shows an image processing system  1300  in accordance with the present invention. The illustrated system includes an imaging site  1302 , a remote analysis site  1304 , a network  1306 , and an optional processing platform  1308 . At the imaging site, the user can operate a speculum system including a speculum  1312  and a device  1310 , as described above, for obtaining one or more images of a subject&#39;s cervix. The resulting digital images can be transmitted to the remote analysis site  1304  via the network  1306 . For example, the network  1306  may include a wireless network and a data network such as the Internet. In one implementation, the user can attach one or more images to an email and send the email to the remote analysis site  1304 . Alternatively, a user may download an application of a processing system in accordance with the present invention to the device  1310 . The application may work in coordination with logic resident on a processor  1314  of the remote analysis site  1304  or resident on the processing platform  1308 . For example, the application on the device  1310  may communicate with such logic via an API defining messaging protocols, data fields, and formats among other things. In this manner, the digital images or enhanced versions thereof may be displayed on the display  1316  at the remote analysis site  1304  for review by an analyst. The analyst can then provide feedback to the user at the imaging site  1302  based on analysis of the images. Such feedback may be provided, for example, by phone, text messaging, email, messaging interfaces of the application running on the device  1310 , or other means. 
     Optionally, images from the imaging site  1302  and other imaging sites may be processed by a processing platform  1308 . For example, the processing platform  1308  may be a cloud-based processing platform and may be embodied in one or more machines at a single location or geographically distributed. The illustrated platform  1308  includes a communications module  1318 , a processor  1320 , a knowledge base  1322  and an image analysis/enhancement module  1324 . The communications module  1318  manages communications with the imaging site  1302  and remote analysis site  1304 , among others, and may perform functionality including formatting messages, extracting data fields from messages, data feature identification and extraction, and the like. 
     The module  1324  is operative to process and enhance imaging information from the site  1302 . For example, the functionality implemented by the module  1324  may include contrast enhancement, resolution enhancement, identifying and analyzing image features or other areas of interest, annotating the image in relation to areas of interests or other information, and comparison of image features to known features and conditions as stored in a knowledge base  1322 . For example, the module  1324  may implement artificial intelligence or machine learning to progressively improve identification of areas of interest within an image and correlation of image features to known or learned medical conditions. 
     The knowledge base  1322  stores knowledge learned from analysis of images. This may include information concerning features, values, variations, correlations involving subject demographic or medical information, or the like. In this regard, the platform  1308  may receive or access various sources of demographic information, medical records, medical literature, and other information to assist in such analysis. The processor  1320  controls operation of the modules  1318 ,  1324 , and  1322 . It will be appreciated that such a cloud-based platform  1308  may have access, over time, to a large volume of imaging information regarding cervical examination so as to develop substantial expertise in identification of potential missions of interest. In some cases, this may enable analysis of conditions at the imaging site  1302  without requiring the expertise of an analyst at a remote platform  1304 . 
     Certain medical procedures may involve ablation, cauterization, or other treatments that may generate smoke at the procedure site. For example, in connection with a cervical examination, a physician may perform a LEEP (Loop Electrosurgical Excisional Procedure) to treat pre-cancers and cancers of the cervix. In such procedures, the wire filament of the electrosurgical device may be heated to about 2000 degrees Fahrenheit and may generate considerable smoke that can obstruct viewing of the surgical site if not removed, potentially resulting in unnecessary tissue burns or resulting in failure to fully remove the diseased tissue. While expensive and bulky smoke evacuators have been used for this purpose in clinical settings, it is envisioned that a compact, and optionally battery-operated fan/vacuum unit may be employed for this purpose in accordance with the present invention. In this regard, the battery and fans of a conventional hand-vac system, modified to interface with an evacuation tube as described below, may be sufficient for many applications. 
       FIGS.  14 A- 14 C  show a speculum system in accordance with the present invention including a mount for holding a smoke evacuation hose. Specifically, the system includes a speculum  1400  and an imaging/data device  1402  as generally described above in connection with  FIGS.  10 A- 10 D . The illustrated system further includes a smoke evacuation tube mount  1404  such as a ring or tube segment for securely receiving a smoke evacuation tube  1406  therein as shown in  FIG.  14 C . The evacuation tube  1406  has one end extending into the internal cavity the speculum  1400  so as to draw smoke from the procedure site. Although the tube mount  1404  is shown as being attached to the imaging/data device mount, it will be appreciated that the tube mount  1404  may alternatively or additionally be disposed on the handle of the speculum, the dilator of the speculum, or another location. For example, a first tube mount element may be provided on the imaging/data device mount as shown and a second tube mount element such as a molded tube support ring may be provided on the dilator of the spectrum to secure the end of the tube. 
     In the illustrated embodiment, the tube mount  1404  is positioned so as to support the smoke evacuation tube  1406  in alignment with the speculum when the imaging/data device mount is rotated away from the speculum opening as shown. The imaging/data device mount and smoke evacuation tube mount may be provided as part of a speculum system kit as described above in connection with  FIGS.  9 A- 9 B . It will be appreciated that the other end of the tube  1406  may be attached to a fan, vacuum device, or other device for drawing air and smoke through the tube away from the procedure site. Such a device may include a power source. For some applications, it may be convenient to provide a battery-operated fan or vacuum device, e.g., to eliminate power cords from the procedure site or where grid power is unavailable or inconvenient to access. 
     In certain situations, it may be desired to mount accessories on the speculum system. For example, it may be desired to mount a smoke evacuation tube, an imaging system element, or an electrosurgical instrument guide/rest on the speculum. Mounting structure may be provided on the dilator of the speculum for this purpose. In this regard,  FIG.  15    shows a dilator  1500  including a notch  1502  and a longitudinal channel  1504  for receiving an accessory mount.  FIGS.  16 A- 16 B  show examples of accessory mounts  1600  and  1604  that may be received within the notch  1502  and longitudinal channel  1504 . Specifically, the mount  1600  includes a base  1601 , dimensioned to be received within the notch  1502  of the dilator  1500 , and a “C” shaped tube receptacle for receiving a smoke evacuation tube  1602 . The mount  1604  includes an elongate base  1607 , dimensioned to be received within the notch  1502  of the dilator  1500 , and one or more receptacles  1606  for receiving an imaging element  1605  of an imaging system. The imaging element  1605  can move longitudinally through the receptacle(s)  1606  so that an imaging detector at the end of the element  1605  is positioned at a desired location in relation to the subject. It will be appreciated that other mounts for other equipment may be provided, for example, as part of a kit as described above. 
     The foregoing description of the present invention has been presented for the purpose of illustration and description. Furthermore, the description is not intended to limit the invention to the form disclosed herein. Consequently, variations and modifications commensurate with the above teachings, and skill and knowledge of the relevant art are within the scope of the present invention. The embodiments described herein above are further intended to explain best modes known of practicing the invention and to enable others skilled in the art to utilize the invention in such or other embodiments and with various modifications required by the particular application(s) or use(s) of the present invention. It is intended that the appended claims be construed to include alternative embodiments to the extent permitted by the prior art.