Vaginal speculum

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, an obturator 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 effected relative to multiple axes, or even in substantially continuous, radial fashion about the periphery of the speculum, for improved visualization. In addition, this speculum has a handle that is oriented such that a vaginal exam can be performed on a standard exam table. The handle also includes a receptacle that receives a standard pen light. A light pipe directs light from the pen light to illuminate the cervix.

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.

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 blade. Nonetheless, the blades are substantially limited to moving apart and back together 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-blade 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 dilatation 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. In addition, the current handles on vaginal speculums are generally oriented at 90 degrees relative to the blades necessitating a specialized gynecologic table with stirrups. Certain existing specula also require a halogen light source that is costly and requires AC/DC current. Lastly, the current speculum on the market when opened creates a very disconcerting clicking sound.

SUMMARY

The present invention provides a new and unique design for a vaginal speculum that reduces or eliminates these existing drawbacks. The ideal speculum, in accordance with the present invention, would be comfortable and non-threatening for the patient, consistently accurate at visualizing the cervix, universal for all body types and anatomy, simple and easy to use for the clinician, and cost effective to manufacture and use on an ongoing basis.

In accordance with one aspect of the present invention, a vaginal speculum is provided that expands in more than one dimension. As noted above, a common type of speculum on the market today expands substantially only in relation to a single dimension. That is, the speculum has two-blades, one of which pivots about an axis so that the associated blade moves on an arcuate path away from or towards the stationary blade. Although the moveable blade and its pivot point may also be moved linearly towards or away from the stationary blade, expansion of the speculum is still substantially limited to a single axis transverse to the longitudinal axis of the blades. This has a number of disadvantages, as described above, including that the vaginal walls of some patients can collapse between the blades impairing visualization of the procedure site.

The inventive speculum in accordance with the present aspect of the invention includes a handle, a dilation assembly for separating and retaining the vaginal walls of a patient and a dilation actuator. The dilation assembly has a proximal end portion near the handle and a distal end portion remote from the handle and is movable between a contracted configuration, wherein the distal end portion has a reduced circumference, and expanded configuration wherein the distal end portion is expanded for improved visualization of the cervix. The dilation actuator is operative to expand the distal end portion of the dilation assembly in relation to at least a first axis and a second axis transverse to the first axis.

Unlike conventional specula that have a stationary blade (fixed in relation to the handle) and a moveable blade, the inventive speculum may include multiple (two or more) moveable blades. Moreover, the inventive speculum preferably has at least three blades. In one embodiment, the speculum has three or more blades, each of which moves outward from a central axis of the dilation assembly. In some embodiments the blades move radially outward whereas, in other embodiments, the blades expand radially outwardly while concomitantly traveling circumferentially in relation to the central axis. Such movement may be actuated by an obturator which is inserted into a hollow interior of the dilation assembly, and withdrawn therefrom, so as to move between the expanded and contracted configurations. The obturator may be moved into and out of the dilation assembly in linear fashion or by operation of a screw mechanism. The speculum may also include a light source receptacle assembly for receiving a light source so that light can be transmitted through the dilation assembly to a procedure site.

In accordance with another aspect of the present invention, a method for using a vaginal speculum is provided. The method includes the steps of: introducing a dilation assembly of a speculum into the introitus of a patient; operating a dilation actuator to expand the dilation assembly with respect to a first axis and with respect to second axis transverse to the first axis; upon concluding a medical procedure, operating the dilation actuator to contract the dilation assembly to a contracted configuration; and withdrawing the dilation assembly from the introitus of the patient. The step of expanding the dilation assembly may involve, for example, advancing an obturator into a hollow interior of the dilation assembly from a proximate end of the dilation assembly so as to force the dilation assembly into the expanded configuration. The process may further involve operating a light source mounted in a handle of the speculum to transmit light through the dilation assembly so as to illuminate the procedure site.

DETAILED DESCRIPTION

In the following description, the invention is set forth with respect certain specific embodiments of vaginal specula. 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.

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 an expanded or open configuration. The speculum100includes a handle102for gripping by a physician or other user, a dilation 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 an obturator106for use in introducing the dilation assembly104into the patient and for forcing the dilation assembly104to the expanded configuration as shown inFIG. 1B. Withdrawing the obturator106from the dilation assembly104allows the dilation assembly104to return to the contracted configuration as shown inFIG. 1A.

The illustrated dilation assembly104includes a number of blades107. As will described in more detail below, at the distal end108of the dilation assembly104, remote from the handle102, the blades107can spread apart from one another so as to define the expanded configuration and can come back together in order to define the contracted configuration. The dilation assembly104preferably includes at least three blades107to allow expansion with respect to at least two axes or two dimensions, e.g., the Y and Z dimensions as shown inFIGS. 1A and 1Bwhere the X, Y and Z axes are mutually orthogonal and the X axis is aligned with the longitudinal axis110of the dilation assembly104. The illustrated dilation assembly104includes four blades107each of which extends about approximately one quarter or 90° of the periphery of the dilation assembly104at the distal end108in the contracted configuration. The blades107may alternatively overlap or remain somewhat separated (e.g., to avoid pinching) in the contracted configuration.

The dilation assembly104has a generally hollow, truncated conical or bullet-shaped configuration. In the contracted configuration as shown inFIG. 1A, the dilation 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 dilation assembly104further includes finger grips114that may be gripped by the physician or other user to facilitate insertion of the obturator106as will be described in more detail below. The dilation assembly104as well as the handle102and/or obturator106may 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 dilation assembly104is formed from a clear plastic resin.

For example, the body of the dilation 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 blades107. Alternatively, the blades107may be formed by appropriate molding. In any event, the blades107in the illustrated embodiment do not extend the full length of the dilation assembly104. Rather, the blades107come together at a location near the proximal end112to form a continuous cylinderal side wall. In this manner, the blades107flex outwardly to the expanded configuration when the obturator of106is advanced into the hollow interior of dilation assembly104from the proximal end112. When the obturator is withdrawn from the hollow interior of the dilation assembly104, the blades107collapse to the contracted configuration, e.g., due to material memory of the clear plastic resin material or forces exerted on the exterior of the dilation assembly104by the vaginal walls of the patient or by the user. Where metal materials are utilized, the dilation assembly104can move between the expanded and the contracted configurations by flexing of the metal materials or by hinge mechanisms.

As noted above, the obturator106may be formed from plastic, metal or other materials. In the illustrated embodiment, the obturator is formed from a clear plastic resin material. The obturator106may have a generally cylindrical or conical configuration and is dimensioned to be received within the hollow interior of the dilation assembly104at the proximal end112thereof. That is, the outside diameter of the obturator106(at least the proximal end thereof) is slightly smaller than the inside diameter of the dilation assembly104at the proximal end112. For example, the outside diameter of the obturator106at its proximal end thereof may be between about 1.5 and 2 inches.

The illustrated obturator106has a thumb grip116extending from the rear surface thereof. The thumb grip116can be gripped by the user to advance the obturator106into dilation assembly104and to withdraw the obturator106from the dilation assembly104. In the illustrated embodiment, the obturator106includes a rib (not shown) extending from the bottom of the obturator. This rib and/or the bottom of thump grip116runs in a longitudinal obturator track118formed in an outer surface of the handle102so as to guide the longitudinal movement of the obturator106. 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 obturator106can be inserted, distal end first, into the dilation assembly104to facilitate introduction of the dilation assembly104into the introitus. The obturator can then be flipped and reinserted into the dilation assembly104proximal (fat) end first to expand the dilation assembly104to the extent desired. In the case of a cylindrical obturator106, the obturator106would be advanced into the dilation assembly104only after the dilation assembly104is positioned within the introitus. In such cases, the dilation assembly104may be bullet-shaped to better resist blade separation during introduction. In this regard, a cylindrical obturator106may facilitate better visualization as it provides a wide aperture across its entire length. The obtuator 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 dilation assembly104via a rotary, screw-like motion.

The illustrated speculum100also includes a silicone sleeve120to protect against penetration of the vaginal walls between the blades and potential pinching. As can be seen inFIG. 1B, the blades107are separated from one another by spaces in the expanded configuration. As the blades107collapse to the contracted configuration, the edges of the blades come together creating a risk that of tissue of a patient will be captured there between and pinched. This risk can be reduced by use of the optional silicone sleeve120. The silicone sleeve120can be placed over the dilation assembly104at one end thereof and unrolled like a condom to extend around substantially the entire external surface of the dilation assembly104. In this manner, the silicone sleeve120guards against collapsing of the patient's uterine wall tissue into the spaces between the blades107.

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 dilation 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 dilation 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 and 2Billustrate a speculum200, generally similar in construction to the speculum100ofFIGS. 1A and 1Bbut with a slightly different configuration, in 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 dilation 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 obturator207into the proximal end of the dilation assembly203so that the blades of the dilation assembly are radially separated.

It will be appreciated, that, in the case of a four bladed dilation assembly as described in connection withFIGS. 1A and 1B, two of the blades may separate along a front to back axis with respect to the patient and two of the blades may separate along a side to side axis with respect to the patient. This creates an unobstructed view. The blades 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 obturator207and dilation 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 obturator207is withdrawn from the dilation assembly203allowing the dilation 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 dilation assembly302a handle304including a receptacle306for holding a light source308and a ratchet assembly310for use in expanding the dilation assembly302. The ratchet assembly310is operated using a thumb lever312.

The speculum300ofFIGS. 3A-3Eshares many characteristics with the speculum ofFIGS. 1A and 1B. For example, the speculum300is used by inserting the dilation assembly302into the patient's introitus with the speculum300in a contracted configuration (as shown inFIGS. 3B and 3C). The speculum300is then expanded to the expanded configuration (as shown inFIGS. 3A and 3D). The light source308can then be activated to illuminate patient's vaginal walls and cervix which can be inspected visually by looking through the hollow dilation assembly302. Moreover, like the embodiment ofFIGS. 1A and 1B, 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 and 1B. In particular, where as the blades inFIGS. 1A and 1Bare separated by spaces at least in the expanded configuration, the blades314of the speculum300overlap as can best be seen inFIGS. 3E and 3G. When the dilation assembly302is expanded or contracted, the blades slide circumferentially over one another (as generally indicated by arrows305) in manner analogons to a collapsible colander. Accordingly, there are no spaces between the blades 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 and 1Bis the mechanism for actuating expansion of the dilation assembly302. Specifically, the dilation 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 expanded configuration. The thumb lever312causes the worm gear of ratchet assembly316to rotate. The worm gear ratchet assembly316is then connected to the proximal ends313of the blades314by appropriate linkage (as shown inFIGS. 3F and 3G) to expand and contract the dilation 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 dilation assembly302may be about 1.5 inches. The diameter, D2, of the distal end of the dilation assembly may be about 1.4 inches in the expanded configuration and about 0.7 inches in the contracted configuration. The dilation 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 blades402generally similar to the blades in the embodiment of theFIGS. 3A-3G. In this case, however, the blades 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 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 dilation assembly502including a number of blades504; a generally cylindrical obturator506for expanding the dilation 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 blades504are formed in an overlapping, collapsible configuration. That is, adjacent blades504extend circumferentially over one another, and slide over one another as the dilation assembly502is expanded and contracted. In this manner, gaps between the blades504are 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 obturator506into and out of the dilation 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 obturator506so that it also moves forward thus expanding the dilation assembly502. The ratchet mechanism514is then effective to hold the speculum in the expanded configuration.

To release the ratchet mechanism514so that the obturator506can be withdrawn from the dilation assembly502to close the blades504, 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 obturator506from the dilation 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 dilation 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 blades504of the illustrated speculum500overlap, as indicated by arrow532, so that there are substantially no spaces between the blades504in the expanded configuration. In this regard, the blades504may 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 blades504may slide circumferentially over one another while expanding like an expandable colander.

The speculum500is preferably dimensioned to accommodate a range of patients. For example, the dilation 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 dilation assembly502has a diameter, D1, of about 1.5 inches. The distal end of the dilation assembly502preferably has a bullet-shaped configuration, as can be seen inFIG. 5E, that helps maintain the assembly502in the contracted configuration as the assembly502is introduced into the introitus. Optionally, one or more pegs534and mating receptacles may be provided at the distal end of the dilation 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 dilation assembly in each case.