Air speculum with flexible vaginal interface

Abstract

A speculum includes a handle including a pressurized gas flow lumen, and a vaginal interface element coupled to a distal end of the handle, which has a flexible cup with folds and an air inlet septum. A probe passes through the vaginal interface element. A vaginal facing membrane covers a distal end of the vaginal interface element inwards with respect to the flexible cup. The probe passes through an air opening in the membrane which allows air to flow past sides of the probe.

Description

AIR SPECULUM WITH FLEXIBLE VAGINAL INTERFACEFIELD OF THE INVENTION

[0001] The present invention relates to vaginal speculums and particularly to a vaginal speculum that uses pressurized gas to maintain a passageway through the vagina, such as to gain access to the cervix or other anatomy.BACKGROUND OF THE INVENTION

[0002] PCT Patent Application PCT / IB2020 / 053647 (WO 2020 / 212923) describes an air speculum. The speculum includes a speculum sheath formed with a first lumen which is in fluid communication with a pump and controller unit for introducing pressurized air into a vagina. A second lumen is in fluid communication with the pump and controller unit for measuring air pressure in the vagina. A third lumen is provided for a viewing device.

[0003] PCT Patent Application PCT / IB2021 / 060539 (WO 2022 / 101864) describes another air speculum, which includes a vaginal interface element which is a soft, flexible cup with folds. The vaginal interface element may be pressed against the labia minora and / or labia majora of the vagina so as to reduce and flow of material outwards.

[0004] PCT Patent Application PCT / IB2023 / 062489 describes another air speculum, which includes a speculum sheath formed with one or more fluid flow lumens in fluid communication with a pump and controller unit for introducing pressurized fluid into a vagina, a pressure sensor lumen in fluid communication with the pump and controller unit for measuring fluid pressure in the vagina, and a third lumen in which is disposed a viewing device. A vaginal interface element includes flexible folds and is configured for pressing and sealing against a vagina. The vaginal interface element includes one or more pressure relief exit ports.SUMMARY OF THE INVENTION

[0005] The present invention seeks to provide an air speculum with added features to those of the air speculum described in PCT Patent Application PCT / IB2023 / 062489, as described in detail below.

[0006] There is thus provided in accordance with a non-limiting embodiment of the present invention a speculum including a handle including a pressurized gas flow lumen, a vaginal interface element coupled to a distal end of the handle, the vaginal interface element including a flexible cup with folds and an air inlet septum, a probe that passes through the vaginal interface element, and a membrane, which is avaginal facing membrane designed to seal against a vulva of a female, and which covers a distal end of the vaginal interface element inwards with respect to the flexible cup, and wherein the probe passes through an air opening in the membrane which allows air to flow past sides of the probe. In one non-limiting embodiment, the probe includes an imaging lumen which includes an optical window and the viewing device is positioned proximal to the optical window, and a biasing device is configured to urge the viewing device to abut against an inner surface of the optical window. The probe may also include a tool channel.

[0007] In accordance with a non-limiting embodiment of the invention an opaque ring is placed at a distal face of the imaging lumen, the opaque ring surrounding the optical window.

[0008] In accordance with a non-limiting embodiment of the invention the optical window is spaced proximally from a distal face of the imaging lumen.

[0009] In accordance with a non-limiting embodiment of the invention gas is flowable from the pressurized gas flow lumen to the vaginal interface element and then flowable through the air opening into a vaginal canal.

[0010] In accordance with a non-limiting embodiment of the invention viewing device is operative to capture images at different focal planes in a vagina or a cervix.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawing in which:

[0012] Figs. 1 and 2 are simplified pictorial and sectional illustrations, respectively, of an air speculum, in accordance with a non-limiting embodiment of the present invention, with a flexible vaginal interface element.

[0013] Fig. 3 is a simplified sectional illustration of the air speculum, showing an imaging lumen, a tool channel, and an optical window.

[0014] Fig. 4 is a simplified end-view illustration of the air speculum, showing the imaging lumen, the tool channel, and the flexible vaginal interface element.

[0015] Fig. 5 is an enlarged illustration of the imaging lumen, showing an opaque ring at the distal face of the imaging lumen and the clear, transparent optical window.

[0016] Fig. 6 is a simplified illustration of the different focal planes in the vagina or cervix.

[0017] Fig. 7 is an illustration of a display of the different focal planes imaged by the system.

[0018] Fig. 8 is an illustration of another version of the air speculum, in which a blower is disposed in the pressurized gas tube to increase and / or regulate the air flow.

[0019] Fig. 9 is an illustration of another embodiment of the air speculum in which the imaging lumen and / or tool channel are movable with respect to the handle.

[0020] Fig. 10 is an illustration of detachment of the vaginal interface element from the handle of the air speculum.DETAILED DESCRIPTION OF EMBODIMENTS

[0021] Reference is now made to Figs. 1 and 2, which illustrate an air speculum frontend 10, or simply air speculum 10, constructed and operative in accordance with a non-limiting embodiment of the present invention. Fig. 2 shows a section of the air speculum frontend shown in Fig. 1.

[0022] Speculum 10 includes a handle 12, which may include a pressurized gas flow lumen 14, into which a pressurized gas tube 16 may be inserted. Gas tube 16 is fluidly connected to a pressurized gas source (e.g. as seen in Fig. 8 and described below, or outside of the handle, which is not shown). Handle 12 may include one or more controls 18, such as on / off, pressure increase / decrease, flow increase / decrease, buttons and other controls related to flow supply or any other parameters of the system described below. The handle 12 of the air speculum 10 may be coupled to a backend server (not shown) or include internally a front end server, that provides air flow 33 (through gas tube 16 and into flow lumen 14) and electric power, and which has a controller that receives camera images and other digital inputs (e.g., flow meter readings, control commands, etc.) and regulates air flow 33. In some cases, electric power for operation may be sourced from batteries inside handle 12 (not shown). In some cases, communication with an external server or with I / O devices (screen, keyboard etc.) may be done wirelessly.

[0023] Handle 12, may further include a viewing device 32. The viewing device 32 may include, without limitation, a small diameter tube camera (e.g., 4-6 mm external diameter) with a wide lens (90°-120° or 90-180°), good resolution (e.g. 2-8 MPxl or spatial resolution of at least 1 pm or at least 10 pm on the subject) and means to transfer imaged data to a controller (e.g. MIPI interface, coax connection, USB connection or other connections known in the art). The small diameter tubecamera may be a fixed focus camera or an autofocus camera comprising a means (e.g. VCM (voice coil motor) actuator) to shift the lens of the camera relative to the camera sensor.

[0024] A distal end 20 of handle 12 is configured to be coupled to a vaginal interface element 40, described below. Vaginal interface element 40 may be connected and / or detached (released) from handle 12, as shown in Fig. 10. Handle 12 may include a button 21 (Fig. 1) to securely connect and / or release vaginal interface element 40. Handle 12 is preferably reusable, whereas vaginal interface element 40 is preferably disposable, but alternatively both could be disposable or reusable, in which case vaginal interface element 40 would be sterilized, disinfected or cleaned before each use, according to known medical standards. Preferably, vaginal interface element 40 is designed to be sealed from fluid transfer from a patient to handle 12, to avoid patient cross contamination. In particular, imaging lumen 30 (see below) is designed to seal viewing device 32 from fluid connection to a patient.

[0025] The vaginal interface element 40 may include a soft, flexible cup 41 with folds 42, shaped as a bellows, for example. Folds 42 are designed to withhold the pressure of the air speculum and / or handle 12 against the exterior of a vagina (e.g. the pubic mound, the vulva, the labia majora) of a female patient. In a preferred embodiment, without limitation, folds 42 are designed to contract under compression by 5-15 mm due to a pressure of 5-20 newton force. The vaginal interface element 40 may include an air inlet septum 44, through which the distal end of pressurized gas tube 16 may be inserted, so that pressurized gas can enter vaginal interface element 40, as designated by reference numeral 33 in Fig. 2.

[0026] Fig. 8 illustrates another version, in which a blower 80 is disposed in pressurized gas tube 16 to increase and / or regulate the air flow 33. Regulation of the air flow may be carried out in a control loop, in which the output of blower 80 is controlled in accordance with information provided to a controller by a sensor, as described below. The air input into air blower 80 (or entering an external air blower, not shown) may be filtered by filter 81. Filter 81 is designed to keep dirt (dust and other particles) from entering the body, as well as keeping air blower 80 clean.

[0027] The air inlet septum 44 seals vaginal interface element 40 against flow lumen 14. The air inlet septum 44 may be offset from the longitudinal central axis of vaginal interface element 40. Folds 42 may be asymmetric with respect to thelongitudinal central axis of vaginal interface element 40; as seen, the folds 42 may be more compressed on one side of the longitudinal central axis as opposed to the opposite side. The folds 42 may be slanted (not perpendicular) with respect to the longitudinal central axis of vaginal interface element 40. Folds 42 allow the application of pressure of the handle and cup on the patient’s body to seal against air leaks.

[0028] An imaging lumen 30 may pass through vaginal interface element 40. Imaging lumen 30 may be rigid and designed to enter the vaginal canal of a female. The imaging lumen may extend distally beyond the flexible cup of vaginal interface. In a preferred embodiment, imaging lumen 30 extends distally beyond the flexible cup of vaginal interface, without limitation, by 2-5 cm, or by 3-4.5 cm. The imaging lumen 30 may house or accommodate the viewing device. In one example, imaging lumen 30 may have an internal diameter larger than the small diameter camera, e.g., without limitation, an internal diameter larger than 6 mm or larger than 7 mm and smaller than 10 mm. Imaging lumen 30 external diameter may be smaller than 12 mm or smaller than 11.5 mm or smaller than 11 mm, such that it can enter easily into a female vagina.

[0029] Reference is now made to Fig. 5. The imaging lumen 30 may be a transparent light guide made of a transparent material, such as but not limited to, polycarbonate, polyethylene, PMMA (poly(methylmethacrylate)), or other engineering plastics. In an embodiment a light source 50, seen in Fig. 10) may be located on handle 12, wherein light from light source 50 travels through imaging lumen 30. In another embodiment light source 50 may be located along viewing device 32 or on the tip of viewing device 32. An opaque ring 36 (e.g., a black ring) may be placed at the distal face 37 of imaging lumen 30 to reduce glare effects from this illumination. The opaque ring 36 may surround a clear, transparent optical window 38. Optical window 38 may be made from a transparent plastic, such as but not limited to, polycarbonate, polyethylene, PMMA or other engineering plastics or from glass. The optical window 38 is preferably proximal to the distal face 37, such as, without limitation, by a distance of 1.2-6 mm, which reduces or completely prevents the window 38 from contacting mucus, tissues, fluids or other debris inside the patient’s vagina. In this application, “distal” means toward the patient side and “proximal” means toward the air input side. In one embodiment, imaging lumen 30 may be designed such that its distal external face is finished in matte plasticmolding (e.g., SPI standard for surface finish grades C1-D3). Such a surface finish may serve as a diffuser for light traveling in the light guide toward patient creating more spread or soft illumination in the scene. In one embodiment, lumen 30 may be designed such that its proximal external and / or all its internal faces are finished in high-gloss plastic molding (e.g., SPI standard for surface finish grade A). Such a surface finish may reduce diffusion (losses of light) toward unwanted directions.

[0030] Referring again to Fig. 2, it is seen that viewing device 32 may be biased by a biasing device 39, such as a coil spring, which urges viewing device 32 to abut against the inner surface of optical window 38. The biasing device 39 reduces the distance between viewing device 32 and window 38 to zero (thus compensating for any distance caused by manufacturing variance in plastic moldings) and thereby increases the optical field of view of viewing device 32. In an embodiment, pressing button 21 (described above) will release vaginal interface element 40, while biasing device 39 presses vaginal interface element 40 away from handle 12, allow disposing vaginal interface element 40 without having to touch it by hand, which may help reduce post examination contaminations.

[0031] As seen in Fig. 2, a tool channel (lumen) 43 may pass through vaginal interface element 40. In some cases, tool channel 43 may be opened from both proximal and distal sides, such that tool channel 43 may facilitate the passage of working tools (such as but not limited to, cutting tools, drug delivery tools, grasping tools, Pap smear test stick, etc.) through vaginal interface element 40 and into the vagina. Tool channel 43 may include a tool channel plug 48 that temporarily seals the passage of a tool channel 43 from air and / or fluid coming out of the vagina during procedures. Plug 48 may be removed and tools may be introduced into the working channel. In some cases, tool channel 43 may be opened from the proximal side and sealed from distal side, such that tool channel 43 may facilitate the passage of tools only into the working channel (such as but not limited to, more imaging tools, RF radiation tools, IR or UV illumination tools, lasers etc.). In some cases, vaginal interface element 40 may be made without a tool channel.

[0032] The vaginal interface element 40 may include one or more pressure relief exit ports (not shown). When vaginal interface element 40 is pressed against the labia minora and / or labia majora and / or vulva of the vagina and pressurized gas is introduced to inflate the vaginal canal, the pressure in the inflated vagina up to the cervix is about equal to the pressure in the inner volume of vaginal interfaceelement 40. This pressure is greater than the external atmospheric pressure. When vaginal interface element 40 is moved away from the labia minora and / or labia majora of the vagina and / or vulva, unwanted air flow sounds may be caused. The pressure relief exit ports prevent such unwanted sounds by venting some of the pressurized gas.

[0033] Figs. 3 and 4 illustrate the vaginal interface element 40 in a front view. Fig.3 is a sectional view and Fig. 4 is an end view. In an embodiment, without limitation, the distance of the top part of flexible cup 41 from probe is 20-45 mm (marked A in Fig. 4). In an embodiment, without limitation, the distance of the bottom part of flexible cup 41 from the probe is 20-30 mm (marked B in Fig. 4). A may be equal to B or they may differ in size. In an embodiment, without limitation, the front face width of flexible cup 41 is 45-55 mm or 40-60mm wide (marked C in Fig. 4). In the front view the tool channel 43 and imaging lumen 30 are seen. A membrane 49, which may be made of a soft polymer or other suitable material, covers the distal end of the vaginal interface element 40, slightly inwards of the end of the flexible cup. The imaging lumen 30 and tool channel 43 pass through an opening in membrane 49. This opening, called air opening 47, allows air to flow past the sides of imaging lumen 30 and tool channel 43. The two channels are designed tangent to one another. Air opening 47 is preferably, although not necessarily, narrow to follow the outer contours of imaging lumen 30 and tool channel 43; thus, since they are tangent to each other, air opening 47 may take on the shape of the number “8”. Other shapes are also within the scope of the invention. In general, there is a probe, which includes imaging lumen 30 and which may additionally include tool channel 43) that passes through the opening in membrane 49. The probe has a cross section in the plane perpendicular to the optical axes of the camera that is concave (in the case of a figure “8” shape, the concave shapes are at the middle of the 8-shape where the upper and lower circles of the “8” meet each other). This concave shape allows air to flow from the cup into the vagina. In an embodiment, without limitation, the area trapped in the concave part of the cross section of the probe (or the sum of areas in case of a few concave parts as seen in Fig. 3 and marked with D) is 5-15 square mm.

[0034] As seen in Figs. 2 and 4, the pressurized gas 33 flows through air opening 47 located around the outer contours of imaging lumen 30 and tool channel 43. Accordingly, pressure is increased through the air speculum 10 in two stages. First,the pressurized gas 33 flows through pressurized gas flow lumen 14 and flows to fill the inner volume of vaginal interface element 40. Next, the pressurized gas 33 flows through air opening 47 into the vaginal canal to build up pressure in the vaginal canal.

[0035] Inflation gas may be used to inflate the vaginal canal at least to 5 mmHg and up to 20 mmHg or up to 30 mmHg, without limitation. The inflation gas may be, without limitation, air, CO2 or nitrogen, for example. In an embodiment a gas pressure sensor (not seen) may be located in or on handle 12 to measure the realtime pressure in the inner volume of vaginal interface element 40 and / or pressurized gas flow lumen 14. A controller (not seen) receives the reading of pressure sensor and controls the flow rate of pressurized gas 33, e.g., by controlling current or voltage drop over blower 80, or by other means of control (e.g., opening or closing electro-mechanical valves). The controller may also use data received from one or more sensors that sense operational parameters of blower 80, such as but not limited to, rotational speed (revolutions per minute (RPM)), or current or electric power consumption, as inputs for control algorithm. A pressure relief valve (not seen) may be employed for safety. The pressure of the inner volume of vaginal interface element 40 may be sensed by the pressure sensor and sent to a control unit that operates in a control loop feedback for optimal safety and efficiency. The controller may also use a combination of readings of pressure sensor, blower rotational speed, blower current consumption and blower voltage drop to identify several situation such as: (1) assembly of vaginal interface element 40 over handle 12, (2) insertion of speculum 10 into the body of a patient, (3) fault (abnormal) pressure sensor readings and (4) filter 81 clogs or blockage.

[0036] Fig. 6 illustrates the different focal planes 75 in the vagina or cervix, which are imaged by the viewing device.

[0037] According to one non-limiting example of operation, the system for vaginal imaging may operate as follows:

[0038] a. Focus on the cervix or vagina, for example on the most proximal plane of focus or the furthest plane of focus.

[0039] b. Change the focus plane to image the cervix or vagina in several focal planes, for example every 50 or 100 micrometers, or for example, on 5-15 focal planes from the most proximal to the furthest focal plane.

[0040] c. Provide the user an image of the cervix or the vagina in all focal planes.

[0041] According to another non-limiting example, the vagina or cervix may be imaged in multispectral imaging. In one case, the illumination in the vaginal canal may be changed in different wavelengths: blue, green, red, deep-red, infra-red, etc., and the images may be combined to a single multicolor image or shown to the user in several panels.

[0042] Fig. 7 illustrates a non-limiting exemplary display 80 of the different focal planes and different color schemes imaged by the system. Such a display may aid the user to identify medical abnormalities (e.g. lesions, scars, fungi etc.).

[0043] Fig. 9 illustrates an option of the air speculum in which the imaging lumen 30 and / or tool channel 43 are movable with respect to the handle 12, while maintaining a proper seal (with air inlet septum 44) from contamination using the soft folds 42 of vaginal interface element 40. In this embodiment, a manipulator 90 may be coupled to the probe that includes imaging lumen 30 and tool channel 43 (or may be optionally coupled just to imaging lumen 30 or just to tool channel 43). Manipulator 90 may be manually moved (or moved by a robotic interface, for example) to move imaging lumen 30 and / or tool channel 43, up and down, or left and right, or tilted with respect to a longitudinal or lateral axis of the device, or a combination of translation and rotation along and / or about any convenient axis. This option increases the viewing capability of the air speculum.

[0044] In some cases, handle 12 may include a wireless communication transmitter capable of short-distance communication (e.g. radio frequency identification (RFID) or near field communication (NFC), not shown in the figure). Vaginal interface element 40 may include a matching ID tag, passive or active, having a unique identifier. In an example, the system may be configured to have a training vaginal interface element (not shown), such as an interface identical in shape, size, materials etc. to all other vaginal interface elements. The training vaginal interface element differs by having a unique identifier marked as “training ID”. Upon connection of the training vaginal interface element to handle 12, the system identifies the training ID and shifts operation to a training virtual reality (VR) mode in which all user communication is simulated in the controller without activating it (e.g., inflating, taking images). The user may thus experience simulation for training and exhibition purposes.

[0045] According to one example, system 10 may have a cradle (not shown) in which handle 12 may be placed (parked) when not used. Parking handle 12 in thecradle may be used for charging internal batteries through dedicated electric connectors or via wireless charging. The NFC transmitter may be used to identify cases in which handle 12 is located in the cradle but not charging well. The system may prompt users in such a case.

Claims

CLAIMSWhat is claimed is:

1. A speculum comprising: a handle comprising a pressurized gas flow lumen and a viewing device; a vaginal interface element coupled to a distal end of said handle, said vaginal interface element comprising a flexible cup with folds and an air inlet septum; a probe which passes through said vaginal interface element; and a membrane, which is a vaginal facing membrane designed to seal against a vulva of a female, and which covers a distal end of said vaginal interface element inwards with respect to said flexible cup, and wherein said probe passes through an air opening in said membrane which allows air to flow past sides of said probe.

2. The speculum according to claim 1, wherein said air opening is positioned such that pressure is increased through said speculum in two stages, wherein gas first flows through said pressurized gas flow lumen and flows to fill an inner volume of said vaginal interface element, and then afterwards the gas flows through said air opening into a vaginal canal to build up pressure in the vaginal canal.

3. The speculum according to claim 1, wherein said probe comprises first and second channels which are tangent to each other.

4. The speculum according to claim 1, wherein said probe comprises an imaging lumen.

5. The speculum according to claim 1, wherein said probe comprises a tool channel.

6. The speculum according to claim 1, wherein said air opening has a shape that follows an outer contour of said probe.

7. The speculum according to claim 4, wherein said imaging lumen comprises an optical window, wherein said viewing device is positioned proximal to said optical window, and a biasing device is configured to urge said viewing device to abut against an inner surface of said optical window.

8. The speculum according to claim 4, wherein an opaque ring is placed at a distal face of said imaging lumen, said opaque ring surrounding said optical window.

9. The speculum according to claim 4, wherein said optical window is spaced proximally from a distal face of said imaging lumen.

10. The speculum according to claim 1, wherein a blower is disposed in said pressurized gas flow lumen.

11. The speculum according to claim 1, wherein a manipulator is coupled to said probe and adapted to move said probe in any combination of translation and / or rotation.

12. The speculum according to claim 1, wherein said air opening has a concave shaped cross section.

13. The speculum according to claim 1, wherein said air opening has an “8” shaped cross section.

14. The speculum according to claim 1, wherein said vaginal interface is detachable from said handle.

15. The speculum according to claim 1, wherein said viewing device is operative to capture images at different focal planes in a vagina or a cervix.

16. The speculum according to claim 4, wherein said imaging lumen seals said viewing device from contamination external to said viewing device.

17. A method for vaginal imaging comprising the following steps: a. focusing on a focus plane at or near a cervix or a vagina; b. changing the focus plane to image the cervix or the vagina in several focal planes; and c. providing images of the cervix or the vagina in all focal planes.

18. The method according to claim 17, wherein the focus plane is the most proximal plane of focus or the furthest plane of focus in the cervix or the vagina.

19. The method according to claim 17, wherein the several focal planes comprise planes located every 50 or 100 micrometers from the most proximal to the furthest focal plane in the cervix or the vagina.

20. The method according to claim 17, wherein the several focal planes comprise 5-15 focal planes from the most proximal to the furthest focal plane in the cervix or the vagina.

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