CROSS-REFERENCE TO RELATED APPLICATIONS

5This application claims priority to U.S. Provisional Patent Application No. 63/296,836 entitled "Adaptive and Radially Expanding Disposable Speculum," filed Jan. 5, 2022, the entire disclosure of which, including the specification and drawings, is incorporated herein by reference.

BACKGROUND OF THE INVENTION

5Speculums have a variety of uses, including use in inspecting and visualizing orifices on humans and animals. These speculums may expand such orifices to allow a user to further examine such orifice and visualize potential concerns and issues.

10One common type of speculum is a vaginal speculum, which typically includes an instrument that allows dilation of the vaginal walls for internal genital organs examination. Current speculum designs, which may be constructed of metal or plastic, often include two hinged blades and a handle. The two blades are "closed" when the speculum is inserted to facilitate its entry and "opened" in its final position where they can be fixed in position by a screw mechanism or the like.

20In addition to hinges, currently known speculums can also include joints, edges, and other structure that can cause discomfort in patients when in contact with the body. The blades of these speculums can also hinder proper visualization or specimen collection. Moreover, the resulting shape created by the speculums, when widened or opened, does not necessarily reflect the generally cylindrical shape of the anatomy and lacks the ability to retain the vaginal walls from covering the visual field to accurately examine the cervix.

30Moreover, speculums may be made of opaque, solid materials and may prevent a user from visualizing the majority of the orifice. In addition, body size and shape varies from patient to patient. However, currently known speculums are not able to adapt to such different sizes and shapes. Because of this, many examinations cannot occur due to the incorrect size of the speculum that is available.

40Additionally, many users struggle to examine an orifice when using a speculum assembly, as the users are required to maintain the speculum assembly at a desirable location and position and are unable to use and access both hands during the examination process. Further yet, currently known speculums must be administered and be put into place by a second person (e.g., physician or other healthcare provider).

50Finally, with currently known speculums, there is a need for sanitation and concerns of cross-contamination exist between patients even after sterilization of the speculum. Accordingly, a need exists for a speculum that allows for maximum visibility, improved comfort, adaptability to various anatomy sizes and shapes, enhanced ability to collect specimens, operation with one hand including by a patient, and adaption for single use.

BRIEF SUMMARY OF THE INVENTION

5The present invention is directed generally to a speculum that includes an expansor. The expansor can be configured to exert an outward force against an orifice into which it is inserted, gradually expand the orifice upon insertion into the orifice, and retain the orifice in an expanded state until the expansor is removed from the orifice.

15The expansor may include a plurality of proximal transition portions, a plurality of distal transition portions, and a plurality of generally longitudinal sections, wherein each longitudinal section extends between a respective proximal transition portion and a respective distal transition portion. In expanding and retaining the orifice, at least the longitudinal sections are configured for engaging a wall of the orifice.

25It will be appreciated that the expansor is radially expending and contracting. The expansor can form a radial compression spring that can be radially compressed when an inward radial force is exerted thereon. It also is adapted for exerting outward radial force, for example when placed in an orifice.

35The expansor can be configured for transitioning between at least (a) a compressed state wherein the expansor has a first cross section or first cross-sectional area, (b) a partially expanded (or partially compressed) state wherein the expansor has a second cross section or second cross-sectional area, and (c) an equilibrium or expanded state wherein the expansor has a third cross section or third cross-sectional area. The second cross-sectional area is greater than the first cross-sectional area, and the third cross-sectional area is greater than the second cross-sectional area.

50The speculum may further include an extraction mechanism that may have a drawstring which, when pulled, engages the proximal transition portions and reduces a cross section of at least a portion of the expansor such that it may be removed from the orifice.

57Another embodiment of the present invention is directed generally to a speculum assembly made up of an expansor (as described above) and an applicator. The applicator may be made up of an outer tube and an inner plunger received at least partially within the tube. The tube is configured for receiving the expansor in a compressed state and inserting it into an orifice in a partially expanded state.

DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

5In the accompanying drawings, which form a part of the specification and are to be read in conjunction therewith in which like reference numerals are used to indicate like or similar parts in the various views:

• 10FIG. 1 is an exploded perspective view of a speculum assembly including a speculum and an applicator in accordance with one embodiment of the present invention;
• FIG. 2 is an assembled perspective view of a speculum assembly including a speculum and an applicator in accordance with one embodiment of the present invention;
• 20FIG. 3A is a first perspective view of the speculum assembly in operation, illustrating the applicator plunger in a fully extended position and the speculum located fully within the applicator in accordance with one embodiment of the present invention;
• FIG. 3B is a second perspective view of the speculum assembly in operation, illustrating the applicator plunger in a partially retracted position and the speculum located partially within and partially extending from the applicator;
• 30FIG. 3C is a third perspective view of the speculum assembly in operation, illustrating the applicator plunger in a fully retracted position and the speculum located entirely within the patient;
• FIG. 3D is a fourth perspective view of the speculum assembly in operation, illustrating the drawstring of the speculum being pulled in order to reduce the diameter of the expansor during removal from the patient;
• 40FIG. 4A is a perspective view of an expansor, illustrating the expansor in a generally expanded orientation in accordance with one embodiment of the present invention;
• FIG. 4B is a top view of the expansor of FIG. 4A;
• 48FIG. 5A is a perspective view of an expansor, illustrating the expansor in a generally contracted orientation in accordance with one embodiment of the present invention;
• FIG. 5B is a top view of the expansor of FIG. 5A;
• 55FIG. 6A is a side view of a speculum including an expansor and an extraction mechanism in accordance with another embodiment of the present invention;
• FIG. 6B is a partial enlarged view of the speculum of FIG. 6A;
• 63FIG. 7A is a perspective of an expansor in a generally expanded orientation in accordance with another embodiment of the present invention;
• FIG. 7B is a top view of the expansor of FIG. 7A;

DETAILED DESCRIPTION OF THE INVENTION

5Various embodiments of the present invention are described and shown in the accompanying materials. For purposes of clarity in illustrating the characteristics of the present invention, proportional relationships of the elements have not necessarily been maintained in the drawings.

12The present invention is directed generally to an improved speculum, applicator assembly, and method of using same. The speculum assembly 10, as best shown in FIGS. 1–2, may include a speculum 12 and an applicator 14. The speculum 12 may include an expansor 16 and an optional attached extraction mechanism 18. According to various embodiments, the extraction mechanism 18 includes a drawstring 20 attached to a loop 22. A user may remove the expansor 16 from an orifice 24 after insertion by using the extraction mechanism 18.

25As shown in FIG. 1, the speculum 12 may be inserted and deployed in an orifice 24 by an applicator 14. The applicator 14 may include a plunger 26 and an outer tube 28. The plunger 26 may have a smaller diameter than the diameter of the outer tube 28, such that the plunger 26 fits within the outer tube 28. According to one embodiment, the plunger 26 is inserted into a base 30 of the outer tube 28, as shown in FIG. 2.

36Turning now to FIGS. 3A–3D, the speculum assembly 10 may be used to insert the expansor 16 into an orifice 24. When the outer tube 28 is being inserted, the plunger 26 may be in a fully extended position and the expansor 16 may be located fully within the applicator 14, as demonstrated in FIG. 3A. The plunger 26 may then be pushed toward the outer tube 28, as shown in FIG. 3B.

47The speculum 12 may be completely removed from the applicator 14 through the distal end 32 upon the plunger 26 being fully inserted into the outer tube 28, as shown in FIG. 3C. As the expansor 16 exits the applicator 14, it expands from a compressed state to a partially expanded state. The expansor 16 will exert a force against the orifice 24 that causes that orifice to expand and be retained in a manner that may allow for an examination or procedure.

57As shown in FIG. 3D, the expansor 16 may be removed from the orifice 24 via an optional extraction mechanism 18. In one embodiment, the extraction mechanism 18 includes a drawstring 20. A loop 22 may be positioned at a terminal end of the drawstring. When the drawstring 20 is engaged, the lower portion 34 of the expansor 16 may be retracted or tightened into a generally frustoconical shape.

5According to one embodiment, and as illustrated in FIGS. 4A–4B, the expansor 16 may have a generally cylindrical cross section. The expansor 16 may take the form of a radial compression spring configured to expand and contract in a generally radial orientation.

14As shown, the expansor 16 may include a plurality of distal or upper transition portions 38 and a plurality of proximal or lower transition portions 40, with generally longitudinal sections 44 extending therebetween. Depending upon its orientation, the distal transition portions 38 may be referred to as forming peaks and the proximal transition portions 40 may be referred to as forming valleys. In one embodiment, the distal and proximal transition portions 38 and 40 may each form a curved portion and may optionally include coils or loops 42. Each individual loop 42 may generally take the form of a torsion spring.

28When in an expanded or equilibrium state, the expansor 16 may have a generally cylindrical cross section, as shown in FIG. 4B, and have a diameter D₁. In one embodiment, when the expansor 16 is in an expanded state, the diameter D₁ may range from 55 to 70 mm.

35The expansor 16 may be forced into a compacted or loaded orientation, as illustrated in FIG. 5A. When in a compacted or retracted orientation, the expansor 16 may have a diameter D₂, as shown in FIG. 5B, which is smaller than the expanded diameter D₁. In one embodiment, when the expansor 16 is in a compact state, the diameter D₂ may range from 15 to 25 mm. The expansor 16 may have a height of 90 to 150 mm.

45According to various embodiments and as shown in FIG. 6A, the extraction mechanism 18 may be attached to the expansor 16 via loops 42 located at the valleys 40 of the expansor 16. The drawstring 20 may be fed through the loops 42 in a manner as shown in FIG. 6B.

57According to one embodiment, the expansor 16 may take the shape, including those as shown in FIGS. 7A and 7B, and may or may not include any loops 42. As further demonstrated in FIGS. 8A and 8B, the longitudinal sections 44 may take on a curved or contoured shape.

5What is claimed is:

1. 7A speculum comprising: an expansor comprising a plurality of proximal transition portions; a plurality of distal transition portions; and a plurality of generally longitudinal sections, each longitudinal section extending between a respective proximal transition portion and distal transition portion; wherein the expansor is configured to exert an outward force against an orifice into which it is inserted; and wherein, upon insertion into the orifice, the expansor is configured to gradually expand to an expanded state, and wherein the expanded state is dependent upon a size and a force exerted by the orifice.
2. 20The speculum of claim 1, wherein the expansor is configured to gradually expand the orifice upon insertion into the orifice.
3. The speculum of claim 2, wherein the expansor is configured to retain the orifice in an orifice expanded state, wherein the orifice expanded state is dependent upon the size and the force exerted by the orifice.
4. 28The speculum of claim 1, wherein at least the longitudinal sections of the expansor are configured to directly contact and engage a wall of the orifice.
5. The speculum of claim 1, wherein the expansor is configured for transitioning between a compressed state wherein the expansor has a first cross section having a first cross-sectional area and a partially expanded state wherein the expansor has a second cross section having a second cross-sectional area, and wherein the second cross-sectional area is greater than the first cross-sectional area.
6. 40The speculum of claim 5, wherein the expansor is further configured for transitioning to an equilibrium state wherein the expansor has a third cross section having a third cross-sectional area, and wherein the third cross-sectional area is greater than the second cross-sectional area.
7. The speculum of claim 1, wherein the expansor forms a radial compression spring that can be radially compressed when an inward radial force is exerted thereon.
8. 50The speculum of claim 1, wherein the speculum is adapted for being delivered via an assembly comprising a plunger, and wherein the plunger is adapted for being at least in a partially retracted position when the expansor is being inserted into the orifice.
9. The speculum of claim 1, wherein gradual expansion of the expansor continues until the expansor reaches an equilibrium, and wherein the equilibrium is based at least in part on the size and the force exerted by the orifice.
10. 60A speculum comprising: an expansor comprising a plurality of proximal transition portions; a plurality of distal transition portions; and a plurality of generally longitudinal sections; and an extraction mechanism that, when engaged, reduces a cross section of only a lower portion of the expansor, wherein the lower portion adopts a generally frustoconical profile when the extraction mechanism is engaged, and wherein the cross section of the lower portion is smaller than a cross section of an upper portion of the expansor; wherein the expansor is configured to exert an outward force against an orifice into which it is inserted.
11. The speculum of claim 10, wherein the extraction mechanism includes a drawstring that, when pulled, engages the proximal transition portions and reduces a cross section of only the lower portion of the expansor.

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