VAGINAL SPECULUM AND CERVICAL SCREENING KIT

A vaginal speculum, conical in shape, made out of clear plastic resin or metal that when closed can easily and gently be inserted into the introitus (vaginal opening). In certain embodiments, a dilator is used to introduce and/or expand the speculum. Various mechanisms are disclosed for dilating the speculum, after it has been inserted, so as to allow inspection of the patient's cervix. Such dilation can be affected relative to multiple axes, or even in substantially continuous, radial fashion about the periphery of the speculum, for improved visualization. In addition, the speculum may include a mount for mounting auxiliary equipment for simplified handling. Such auxiliary equipment may include imaging elements, electrosurgical equipment, and smoke evacuation equipment, among other things. Associated processing equipment enables processing of image information locally or remotely via a data network.

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'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'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'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'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'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'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'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.

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.

FIGS.1Aand B illustrate perspective views of a speculum100in accordance with the present invention. Specifically,FIG.1Aillustrates the speculum100in contracted or closed configuration andFIG.1Billustrates the speculum100in a dilated or open configuration. The speculum100includes a handle102for gripping by a physician or other user, a petal assembly104for 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 dilator106for use in introducing the petal assembly104into the patient and for forcing the petal assembly104to the expanded configuration as shown inFIG.1B. Withdrawing the dilator106from the petal assembly104allows the petal assembly104to return to the contracted configuration as shown inFIG.1A.

The illustrated petal assembly104includes a number of petals107. As will described in more detail below, at the distal end108of the petal assembly104, remote from the handle102, the petals107can 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 assembly104preferably includes at least three petals107to allow expansion with respect to at least two axes or two dimensions, e.g., the Y and Z dimensions as shown inFIGS.1A and1Bwhere the X, Y and Z axes are mutually orthogonal and the X axis is aligned with the longitudinal axis110of the petal assembly104. The illustrated petal assembly104includes four petals107each of which extends about approximately one quarter or 90° of the periphery of the petal assembly104at the distal end108in the contracted configuration. The petals107may alternatively overlap or remain somewhat separated (e.g., to avoid pinching) in the contracted configuration.

The petal assembly104has a generally hollow, truncated conical or bullet-shaped configuration. In the contracted configuration as shown inFIG.1A, the petal assembly104has a diameter, D1, at the proximal end112, thereof, adjacent the handle102of about two inches and a diameter, D2, at the distal end thereof about 0.75 inches. In the expanded configuration as shown inFIG.1B, the diameter D2is, for example, about 1.5 inches. The illustrated petal assembly104further includes finger grips114that may be gripped by the physician or other user to facilitate insertion of the dilator106as will be described in more detail below. In the illustrated embodiment, as in the embodiments described below, the petal assembly104as well as the handle102and/or dilator106may 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 speculum100may be constructed from metal materials to allow for sterilization and reused if desired. In the illustrated embodiment, the petal assembly104is formed from a clear plastic resin.

For example, the body of the petal assembly104may 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 end112to define the petals107. Alternatively, the petals107may be formed by appropriate molding. In any event, the petals107in the illustrated embodiment do not extend the full length of the petal assembly104. Rather, the petals107come together at a location near the proximal end112to form a continuous cylinderal side wall. In this manner, the petals107flex outwardly to the expanded configuration when the dilator106is advanced into the hollow interior of petal assembly104from the proximal end112. When the dilator is withdrawn from the hollow interior of the petal assembly104, the petals107collapse 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 assembly104by the vaginal walls of the patient or by the user. Where metal materials are utilized, the petal assembly104can move between the expanded and the contracted configurations by flexing of the metal materials or by hinge mechanisms.

As noted above, the dilator106may be formed from plastic, metal or other materials. In the illustrated embodiment, the dilator is formed from a clear plastic resin material. The dilator106may have a generally cylindrical or conical configuration and is dimensioned to be received within the hollow interior of the petal assembly104at the proximal end112thereof. That is, the outside diameter of the dilator106(at least the proximal end thereof) is slightly smaller than the inside diameter of the petal assembly104at the proximal end112. For example, the outside diameter of the dilator106at its proximal end thereof may be between about 1.5 and 2 inches.

The illustrated dilator106has a thumb grip116extending from the rear surface thereof. The thumb grip116can be gripped by the user to advance the dilator106into petal assembly104and to withdraw the dilator106from the petal assembly104. In the illustrated embodiment, the dilator106includes a rib (not shown) extending from the bottom of the dilator106. This rib and/or the bottom of thump grip116runs in a longitudinal dilator track118formed in an outer surface of the handle102so as to guide the longitudinal movement of the dilator106. The thumb grip116may be ergonomically shaped and textured so as to facilitate operation by a physician or other user. In the case of a conical dilator106can be inserted, distal end first, into the petal assembly104to facilitate introduction of the petal assembly104into the introitus. The dilator can then be flipped and reinserted into the petal assembly104proximal (fat) end first to expand the petal assembly104to the extent desired. In the case of a cylindrical dilator106, the dilator106would be advanced into the petal assembly104only after the petal assembly104is positioned within the introitus. In such cases, the petal assembly104may be bullet-shaped to better resist petal separation during introduction. In this regard, a cylindrical dilator106may facilitate better visualization as it provides a wide aperture across its entire length. The dilator106may 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 assembly104via a rotary, screw-like motion.

The illustrated speculum100also includes a latex sleeve120to protect against penetration of the vaginal walls between the petals and potential pinching. As can be seen inFIG.1B, the petals107are separated from one another by spaces in the expanded configuration. As the petals107collapse 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 sleeve120. The latex sleeve120can be placed over the petal assembly104at one end thereof and unrolled like a condom to extend around substantially the entire external surface of the petal assembly104. In this manner, the latex sleeve120guards against collapsing of the patient's uterine wall tissue into the spaces between the petals107.

The handle102of the illustrated embodiment has a generally cylindrical configuration. If desired, the exterior surface of the handle102may be formed for improved ergonomics. The illustrated handle102has a hollow interior cylinder receptacle122dimensioned to receive a light source. The light source can be activated by the user to transmit light through the handle102and through the petal assembly104so as to illuminate a procedure site such as the patient's uterine walls and/or cervix. In the illustrated embodiment a light pipe124is formed in a portion of the petal assembly104to 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 speculum100, the illustrated speculum100can also be designed to receive an inexpensive pen light within the cylinder receptacle122. The cylinder receptacle122may 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 receptacle122. 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 receptacle122.

FIGS.2A and2Billustrate a speculum200, generally similar in construction to the speculum100ofFIGS.1A and1Bbut with a slightly different configuration, for use on a patient. Specifically, in use, the speculum200can be introduced into the introitus of the patient in a contracted configuration as shown inFIG.2A. As shown, the speculum200is advanced into the patient until the distal end of the speculum200is adjacent to the patient's cervix201. It will be appreciated that the speculum200is dimensioned appropriately in this regard. For example, the petal assembly203may have a length of about 6.5 inches and the handle205may 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 speculum200has been inserted to the full extent desired, the physician or other user can advance the dilator207into the proximal end of the petal assembly203so 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 withFIGS.1A and1B, 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 handle205to 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 dilator207and petal assembly203to 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 dilator207is withdrawn from the petal assembly203allowing the petal assembly203to collapse to the contracted configuration. The speculum200can then be withdrawn from the patient's introitus and disposed of and or sterilized as appropriate.

FIGS.3A-3Gillustrates a speculum300constructed in accordance with alternative embodiment of the present invention. The speculum300generally includes a petal assembly302a handle304including a receptacle306for holding a light source308and a ratchet assembly310for use in expanding the petal assembly302. The ratchet assembly310is operated using a thumb lever312.

The speculum300ofFIGS.3A-3Eshares many characteristics with the speculum ofFIGS.1A and1B. For example, the speculum300is used by inserting the petal assembly302into the patient's introitus with the speculum300in a contracted configuration (as shown inFIGS.3B and3C). The speculum300is then expanded to the dilated configuration (as shown inFIGS.3A and3D). The light source308can then be activated to illuminate patient's vaginal walls and cervix which can be inspected visually by looking through the hollow petal assembly302. Moreover, like the embodiment ofFIGS.1A and1B, the speculum300expands radially with respect to multiple axes for improved viewing without interference due to collapsing vaginal walls.

However, the speculum300has some differences in relation to the embodiment ofFIGS.1A and1B. In particular, whereas the petals inFIGS.1A and1Bare separated by spaces at least in the expanded configuration, the petals314of the speculum300overlap as can best be seen inFIGS.3E and3G. When the petal assembly302is expanded or contracted, the petals slide circumferentially over one another (as generally indicated by arrows305) 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 speculum300and that ofFIGS.1A and1Bis the mechanism for actuating expansion of the petal assembly302. Specifically, the petal assembly302is expanded by operation of the thumb lever312. The thumb lever312interfaces with a worm gear ratchet as shown inFIG.3Fsuch that depressing the thumb lever closes the speculum300to the contracted configuration and pulling outwardly on the thumb lever312causes the speculum300to be expanded to the dilated configuration. The thumb lever312causes the worm gear of ratchet assembly316to rotate. The worm gear ratchet assembly316is then connected to the proximal ends313of the petals314by appropriate linkage (as shown inFIGS.3F and3G) to expand and contract the petal assembly302as desired.

The illustrated speculum300is dimensioned to accommodate a range of patients including larger patients. For example, the diameter D1, of the proximal end of the petal assembly302may be about 1.5 inches. The diameter, D2, 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 assembly302has a length, L1, of about 6.5 inches and the handle304has a length, L2, of about 3.5 inches for an overall length, L3, of about 10 inches for the speculum300.

FIGS.4A-4Eillustrate a still further embodiment of a speculum400in accordance with the present invention. The speculum400includes a number of overlapping speculum petals402generally similar to the petals in the embodiment of theFIGS.3A-3G. In this case, however, the petals are expanded and contracted directly by rotating retention ring404rather than using a ratchet assembly as described in connection with the embodiment ofFIGS.3A-3G. In addition, the handle406is offset vertically, by offset structure407, from the expansion assembly408which may facilitate visual inspection through the expansion assembly408. The handle406further includes a receptacle410for receiving a light source and a light pipe412for directing light from the source to the patient's cervix.

FIGS.5A-5Fillustrate a speculum500in accordance with a still further embodiment of the present invention. The speculum500is similar to the speculum100ofFIGS.1A-1B, with some additional features shown and minor differences in configuration. The speculum500generally includes: a generally conical petal assembly502including a number of petals504; a generally cylindrical dilator506for expanding the petal assembly502and allowing it to contract; and a handle508including a receptacle510for receiving a light source512. As discussed above, the speculum can be formed, for example, from clear plastic or metal as desired.

The illustrated petals504are formed in an overlapping, collapsible configuration. That is, adjacent petals504extend circumferentially over one another, and slide over one another as the petal assembly502is expanded and contracted. In this manner, gaps between the petals504are avoided, even in the expanded configuration, thus reducing the likelihood that tissue of the patient will be pinched due to operation of the speculum500.

The speculum500further includes a ratchet mechanism514for advancing and withdrawing the dilator506into and out of the petal assembly502. The ratchet mechanism514includes a ratcheted handle surface516that interfaces with a bottom of a thumb lever518. The thumb lever518includes an advance surface520and a release surface522. The physician or other user can press on the advance surface520, as generally indicated by arrow524, to move the thumb lever518forward. The thumb lever518presses against the dilator506so that it also moves forward thus expanding the petal assembly502. The ratchet mechanism514is then effective to hold the speculum in the expanded configuration.

To release the ratchet mechanism514so that the dilator506can be withdrawn from the petal assembly502to close the petals504, the user can press on the release surface522as generally indicated by arrow526. This causes the rear edge of the thumb lever578to lift and disengages the ratchet mechanism514. The user can then slide the thumb lever518rearwardly to withdraw the dilator506from the petal assembly502.

As noted above, the handle508includes a receptacle510for receiving a light source512. Although any appropriate light source can be used, the illustrated receptacle510can receive a low-cost pen light type of light source512, thereby reducing costs and inconvenience in relation to some conventional systems. The light source512may 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 handle508, and directed through the petal assembly502to the procedure site by a plastic light pipe528. Optionally, a brightly colored tag530or strap may be attached to the light source512to assist in locating the light source and to remind the user not to accidentally dispose of the light source512when the speculum500is discarded after a single use.

The petals504of the illustrated speculum500overlap, as indicated by arrow532, so that there are substantially no spaces between the petals504in the dilated configuration. In this regard, the petals504may 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 petals504may slide circumferentially over one another while expanding like an expandable colander.

The speculum500is preferably dimensioned to accommodate a range of patients. For example, the petal assembly502may have a length L1, of about 3.5 inches and the handle508may have a length, L2, of about 3.5 inches for an overall speculum length of 7 inches. In the contracted configuration, the distal end of the petal assembly502has a diameter, D1, of about 1.5 inches. The distal end of the petal assembly502preferably has a bullet-shaped configuration, as can be seen inFIG.5E, that helps maintain the petal assembly502in the contracted configuration as the petal assembly502is introduced into the introitus. Optionally, one or more pegs534and mating receptacles may be provided at the distal end of the petal assembly502to 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 speculum600in accordance with the present invention is shown inFIGS.6A-9B. The speculum600generally includes a speculum body602and a dilator604. The speculum body602, in turn, includes a petal assembly606and a handle608.

FIG.6Ashows the speculum600in a retracted configuration andFIG.6Bshows the speculum600in a dilated configuration. The speculum600is moved between the retracted and dilated configurations by advancing or withdrawing the dilator604relative to the speculum body602along the longitudinal axis610of the speculum600. In the fully inserted position of the dilator604, corresponding to the fully dilated configuration of the speculum600, the collar614of dilator604buts against the rear surface616of the speculum body602. The dilator604also includes ratchet teeth618that allow the dilator604to 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's assistant, clinic staff member or other person, can insert a light source607(FIG.9B) into the handle608, 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 speculum600, if desired, and a lubricant may be applied to the sheath or forward end. The user can then grip the speculum600using the handle608and advance the forward end620of the speculum620into the patient and advance the speculum600until the speculum600meets resistance. At that point, the user may press against the rear flange622of the dilator604, for example, using the thumb of the same hand that grips the handle608or the user's other hand, and advances the dilator604in relation to the speculum body602to 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 lever624, for example, using the thumb of the same hand that grips the handle608or the user's other hand, allowing the dilator604to be withdrawn from the speculum body602to reach the fully retracted configuration. The speculum600can then be readily withdrawn from the patient.

The handle608of the illustrated speculum600is angled in relation to the petal assembly606. More specifically, the handle608is oriented such that an angle, θ, that is less than 90°, is defined between the longitudinal axis612of the handle608in relation to the longitudinal axis610of the speculum600and petal assembly606. 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 dilator604. At the same time, the angled configuration positions the user's hand on the handle608outside of a line of viewing and access to the patient generally corresponding to the longitudinal axis610. 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.7A-7Eshow various views of the speculum body602. More specifically,FIGS.7A-7Cshow the speculum body602alone in order to better illustrate certain features whereasFIG.7Dshows the full speculum600including the speculum body602and the dilator604.FIG.7Eshows an expanded view of certain portions of the speculum body602. As shown, the speculum body602includes the petal assembly606and the handle608. The petal assembly606includes a number of petals626. The number of petals626may vary, but the assembly606will generally include at least three petals626so as to allow for dilation relative to more than one axis for improved treatment site visualization and access. The assembly606may have many petals with the upper limit being determined by practical considerations such as ensuring that each petal626is 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 petals626, and the amount of support provided by the dilator604when inserted into the assembly606. In the illustrated embodiment, five petals626are provided in the petal assembly606.

At the forward end620of the assembly606, each of the petals626is rounded and turned inwardly toward a centerline (generally corresponding to the axis610ofFIGS.6A-6B) so as to define a blunt nose shape to the forward end620for improved penetration and patient comfort. The petals626are separated by slots628. The slots628are shaped such that the edges of adjacent petals626are substantially abutting when the petal assembly606is in the fully retracted position. In this manner, the risk of pinching during insertion and withdrawal is reduced. The edges of the petals626may also be slightly rounded or otherwise shaped so as to reduce pinching during transition from the dilated configuration to the retracted configuration of the assembly606. In addition, as shown, the base630of each of the slots628may be rounded so as to eliminate stress points and potential cracking of the speculum body structure.

As noted above, the petals626are turned inwardly at the front end620to define a blunt nose shape. Specifically, the petals626may turn inwardly over the last 0.25 inches adjacent the tips of the petals626. At the start of this turn, the front end may have a diameter d1(FIG.7A), of no more than about 0.75 inches, for example, about 0.5 inches, in the contracted configuration, and a diameter, d2(FIG.6B), of at least 1.5 inches, for example, about 1.75 inches, in the dilated configuration.

In addition, the length of the handle608may 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 base640may include ribs or other contouring for improved gripping and ergonomics. The overall length of the petal assembly606may be between about 4-7 inches, for example, between about 5-6 inches. The illustrated assembly is about 5.5 inches long. The individual blades626may 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 speculum600may be about 0.06-0.15 inches with the thickness varying, e.g., to define flex points.

The overall length of the dilator604may 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 collar614to the front end of the dilator604may be between about 4-5 inches, for example, about 4.5 inches. The diameter of the dilator604is selected to extend within and expand the blade assembly606. As noted above, the diameter of the dilator604may taper over at least a front section thereof. In the illustrated embodiment, the inside diameter of the dilator604at 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 speculum600may be provided in other sizes, e.g., for young or small patients (or larger patients).

The petal assembly606is connected to the handle608via a reinforced central section634. Hinge portions632may be defined where each of the petals626meets the central section634. In the illustrated embodiment, the speculum body602is formed from molded plastic. The hinge portion632is provided at a narrowed area of each of the petals626corresponding to the widened base630of the slots628. The thickness of the plastic may be slightly reduced at the hinge portion632to define a fabric hinge. The fabric hinge632thus defines the principal location of flexion associated with moving between the dilated and retracted configurations of the assembly606. More specifically, when the dilator604is advanced forwardly so that the forward edge of the dilator604extends beyond the hinge portion632the dilator604begins to press outwardly against the inner surfaces of the petals626causing the petals626to flex outwardly at the hinge portion632.

As best seen inFIG.7D, the handle608has a generally U-shaped cross-section defined by a base640and sidewalls642with an open top644. A light source receptacle646is provided in the interior area of the handle608. The receptacle646is defined by receptacle walls648and650. The walls648and650are 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 receptacle646thus 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 walls648and650further includes continuous or intermittent retaining members645for retaining the light source in the receptacle646. The members645are disposed adjacent the upper ends of the walls648and650away from the base640of the handle608, and extend slightly inwardly toward the center of the receptacle646and towards the opposing wall. The plastic walls648and650can flex sufficiently to allow the light source to be inserted into the receptacle646via the open top644of the handle608such that the light source snaps into place in the receptacle. Alternatively, the light source can be inserted into the receptacle646longitudinally by sliding the light source along the length of the receptacle646.

The open top configuration of the handle608and receptacle646also 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 stop652at the forward end of the receptacle646defines the forwardmost position of the light source in the receptacle646. In this manner, the sidewalls648and650together with the stop652ensure proper positioning of the light source so that the light source is aligned as desired with the light directing block656as will be described in more detail below. In this regard, the stop652extends upwardly from the base640of the handle608sufficiently to engage and stop the light source but without blocking light from the light source. The illustrated stop652has a generally semicircular cross-section and is received within a correspondingly shaped recess653formed in the base640of the handle608.

The central section634connects the handle608to the petal assembly626, serves as a mounting structure for various elements as will be described below, and receives the dilator604. Accordingly, the central section634will bear substantial forces in operation and needs to be sufficiently strong and stiff. In this regard, the central section634may 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 section634is formed from inner636and outer638members that collectively thicken and reinforce the central section634as well as simplifying manufacturing. The inner member636and outer member638include complementary tongue and groove connections657that allow for convenient sliding interconnection as well as proper alignment and orientation of the members636and638. A groove658formed in the inner member636receives the ratcheting teeth618(FIG.6A) of the dilator604and a recess660formed in the groove658allows each tooth618to register and lock into position. For example, the teeth618may be spaced so as to correspond to 0.125-0.25 inch measurements in dilation diameter of the petal assembly606. The inner member636and outer member638also have slots formed therein for receiving the light directing block656including the dilator retaining guides654as will be described in more detail below.

FIG.7Eshows expanded perspective views of the light directing block656and the stop652. Although these components are illustrated as separate pieces, the block656and stop652may be formed as a single integral unit or both the block656and stop652may be integrally formed (e.g., molded) as part of the speculum housing602. In the illustrated implementation, the block656is provided as a separate molded plastic piece that is placed in position and fused or bonded to the base of the central portion634of the speculum housing602. Similarly, the illustrated stop652is provided as a separate molded plastic piece that can be received in the channel653of the handle608and can then slide forward in the channel until it abuts the bottom of the block656. The stop652can then be fused or bonded in the desired position.

The illustrated block656includes stop retaining guides654. As will be understood from the description below, the guides654extend through a slot formed on the bottom surface of the dilator to guide the sliding motion of the dilator604through the petal assembly606. In addition, the front surfaces of the guides654abut against the rear surface of the slot formed in the dilator604to define the forwardmost position of the dilator604with respect to the petal assembly606. The forward surface of the guides654also abut against the forwardmost end of the slot formed in the dilator604to define the fully retracted position of the dilator604with respect to the petal assembly606and to prevent inadvertent separation of the dilator604from the speculum body602.

When the light source is placed in the receptacle646and turned on, light passes above the upper surface of the stop652generally in the direction indicated by arrow657and is incident on a bottom surface of the guide656. If desired, a face may be molded into the bottom surface of the guide656and oriented normal (or in another desired orientation) to the direction of the light657. Through processes of refraction, diffusion and/or internal reflection, light exits the forwardmost surfaces of the block656and guides654generally in the direction indicated by arrow659. 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 body602and dilator604, is sufficient to illuminate the procedure site at the front end of the speculum600. The direction659of the exiting light is thus generally aligned with the longitudinal axis of the speculum600.

FIGS.8A-8Cshow various views of the dilator604. Like the other parts of the speculum600, the dilator604may be formed from molded transparent plastic. As shown, the dilator604is slightly tapered from its rear end662its forward end662. This shape better matches the shape of the inner surfaces of the petal assembly606, facilitates insertion of the dilator604into the petal assembly606and supports the petal assembly606under pressure from the vaginal walls in the dilated configuration. The speculum600may 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 dilator604includes a thumb flange at the rear end660thereof that the user can press to advance the dilator604. The dilator604also includes a collar to limit forward movement of the dilator604relative to the speculum body602. The ratchet teeth618are formed on a cantilevered lever defined by slots666. The cantilevered lever664is sufficiently flexible that the lever664can be depressed by pressing on the finger grip668so as to release the teeth618from the recess660. In this manner, the dilator604can be readily withdrawn from the speculum housing602and the dilator604can be advanced into the speculum body602to a desired position without a clicking sound that may be distracting to some patients. The forward ends of the slots666flare outwardly slightly from a centerline of the dilator604to reduce any structural weakness associated with a single flexion point of the cantilevered portion664. The bottom surface of the dilator604includes an elongate slot668. The slot668receives the guides654(FIG.7F) and allows for controlled sliding of the dilator604in relation to the speculum housing602. A stop670is provided at the forward end of the slot668to define the fully retracted position of the dilator604in relation to the speculum body602and to inhibit inadvertent separation of the dilator604from the speculum body602. The stop670is sized, in conjunction with the tapered shape of the dilator604, to enable separation of the dilator604from the speculum body602when 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 inFIGS.9A-9Bwhich also provide a convenient set of illustrations for describing the kit. Referring toFIG.9A, 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 toFIG.9B, 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 panel10to 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'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'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'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.10A-10Dshow a speculum system1000in accordance with the present invention. The system1000enables a portable imaging/networking device such as a phone1002to be mounted on an improved speculum1012such 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's cervix and to transmit those digital images to a remote analyst for analysis, e.g., via email or other networking functionality.

The illustrated system1000includes a mounting member1004, a first adjustable support assembly1006, a second adjustable support assembly1008, and an assembly mount1010. The mounting member1004is configured to snap into the handle1014of the speculum1012. As discussed above, the speculum1012is formed to receive an illumination source such as a penlight in a channel of the handle1014so as to illuminate the subject's cervix. The structure can be used to receive the mounting member1004. For example, the mounting member1004may be a penlight or a dedicated mounting member1004having similar dimensions.

The first and second support assemblies1006and1008are adjustable to receive a variety of devices1002. One practical implementation is adapted to support a phone1002such 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 assemblies1006and1008may be adjustable to securely hold smart phones of a variety of dimensions. In addition, the assemblies1006and1008may allow for vertical positioning of the smart phone so that a camera of the smart phone is aligned with an axis of the speculum1012to obtain an image of the subject's cervix. In this regard, the assembly1006may include slides or other telescoping mechanisms to enable longitudinal expansion and contraction to engage the sides of the phone1002. Similarly, the assembly1008may include slides or other telescoping mechanisms to allow the mechanism1008to be vertically raised or lowered to position the camera of the device1002as desired.

The illustrated system1000also includes a mount1010for mounting the device support assembly1001on the mount member1004. In the illustrated embodiment, the assembly1001is substantially permanently mounted on the member1004using bands, zip ties, or other mounting structure. Alternatively, the assembly1001may be removably mounted on the member1004via a snapping plastic grip or similar mechanism. The assembly1001may further include an adjustable joint1016for allowing the assembly1001to be movable so as to move the device1002to a desired position and angle. In this regard, joint1016may rotate or pivot and translate or allow for linear motion of the assemblies1006and1008relative to the mount1004. Moreover, as shown inFIG.10D, the joint1016also allows the device1002two 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.11A-11Cshow another embodiment of a speculum system1100in accordance with the present invention. The system1100includes a speculum600that is generally similar to the speculum described above in connection withFIGS.6A-6Band corresponding elements identified by the same reference numerals as in those Figs. However, the illustrated system1100further includes a removable imaging system680that can be movably mounted on the handle608. As shown, the imaging system680includes an elongate body681and a digital imaging detector682. Alternatively, the system680may include a fiber optic element connected to a remote detector. Although not shown, the system680may further include lenses, filters, fiber optic reducers, or other imaging elements. The body681is movably mounted in an elongate slot684formed in the handle608. For example, the body681may include one or more protrusions that are received in an opening686at an end of the slot684. In this manner, the body681and detector682can move longitudinally within the slot684.

FIGS.11A-11Cshow the body in a fully withdrawn position (FIG.11A), for example, to avoid interfering with viewing or performing medical procedures on the patient's cervix, a partially inserted position (FIG.11B), and a fully inserted position (FIG.11C), for example, for obtaining images of the subject's cervix. It will be appreciated that the body681can extend through an opening formed in the body of the speculum600and dilator604. For example, such openings may be circular, rectangular, or, in the case of the dilator604, an elongate slot to permit movement of the dilator604in relation to the body of the speculum600. The illustrated system1100further includes a cord688for 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.12A-12Bshow a further embodiment of a speculum system1200in accordance with the present invention. The illustrated system1200includes a speculum600, such as described above in connection withFIGS.6A-6B, and a colposcope hand-held imaging device1202. As shown inFIG.12B, the device1202can be longitudinally inserted into the central opening of the speculum600to obtain images of the subject's cervix. In this regard, the illustrated speculum600includes a device support1204that is hingedly mounted on the handle608of the speculum600at pivot1206. In this manner, the support1204is movable between a retracted position, where the support1204is withdrawn into the handle608and a deployed position, as shown inFIG.12B, where the support1204supports the body of the device1202. The support1204may 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 device1202to further secure the device1202within the dilator of the speculum600. It will be appreciated that the system1200thus allows a user to conveniently position both the speculum600and the device1202using the handle608. The user's other hand is thus available to operate light and camera controls1208on the device1202or for other operations.

FIG.13shows an image processing system1300in accordance with the present invention. The illustrated system includes an imaging site1302, a remote analysis site1304, a network1306, and an optional processing platform1308. At the imaging site, the user can operate a speculum system including a speculum1312and a device1310, as described above, for obtaining one or more images of a subject's cervix. The resulting digital images can be transmitted to the remote analysis site1304via the network1306. For example, the network1306may 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 site1304. Alternatively, a user may download an application of a processing system in accordance with the present invention to the device1310. The application may work in coordination with logic resident on a processor1314of the remote analysis site1304or resident on the processing platform1308. For example, the application on the device1310may 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 display1316at the remote analysis site1304for review by an analyst. The analyst can then provide feedback to the user at the imaging site1302based 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 device1310, or other means.

Optionally, images from the imaging site1302and other imaging sites may be processed by a processing platform1308. For example, the processing platform1308may be a cloud-based processing platform and may be embodied in one or more machines at a single location or geographically distributed. The illustrated platform1308includes a communications module1318, a processor1320, a knowledge base1322and an image analysis/enhancement module1324. The communications module1318manages communications with the imaging site1302and remote analysis site1304, among others, and may perform functionality including formatting messages, extracting data fields from messages, data feature identification and extraction, and the like.

The module1324is operative to process and enhance imaging information from the site1302. For example, the functionality implemented by the module1324may 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 base1322. For example, the module1324may 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 base1322stores 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 platform1308may receive or access various sources of demographic information, medical records, medical literature, and other information to assist in such analysis. The processor1320controls operation of the modules1318,1324, and1322. It will be appreciated that such a cloud-based platform1308may 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 site1302without requiring the expertise of an analyst at a remote platform1304.

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.14A-14Cshow a speculum system in accordance with the present invention including a mount for holding a smoke evacuation hose. Specifically, the system includes a speculum1400and an imaging/data device1402as generally described above in connection withFIGS.10A-10D. The illustrated system further includes a smoke evacuation tube mount1404such as a ring or tube segment for securely receiving a smoke evacuation tube1406therein as shown inFIG.14C. The evacuation tube1406has one end extending into the internal cavity the speculum1400so as to draw smoke from the procedure site. Although the tube mount1404is shown as being attached to the imaging/data device mount, it will be appreciated that the tube mount1404may 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 mount1404is positioned so as to support the smoke evacuation tube1406in 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 withFIGS.9A-9B. It will be appreciated that the other end of the tube1406may 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.15shows a dilator1500including a notch1502and a longitudinal channel1504for receiving an accessory mount.FIGS.16A-16Bshow examples of accessory mounts1600and1604that may be received within the notch1502and longitudinal channel1504. Specifically, the mount1600includes a base1601, dimensioned to be received within the notch1502of the dilator1500, and a “C” shaped tube receptacle for receiving a smoke evacuation tube1602. The mount1604includes an elongate base1607, dimensioned to be received within the notch1502of the dilator1500, and one or more receptacles1606for receiving an imaging element1605of an imaging system. The imaging element1605can move longitudinally through the receptacle(s)1606so that an imaging detector at the end of the element1605is 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.