Transvaginal device for improving the examination for early detection of the risk of cervical cancer

Abstract

The present invention relates to a transvaginal device designed to improve gynaecological examination, comprising a base supporting a fork in a sliding manner, this fork being hingedly attached to an arm by means of pivots. The base incorporates a fixed sheath having a predetermined inclination and containing part of an intermediate bend. This intermediate bend houses an endoscopic camera that has a fixed focus distance and is connected to an image processing unit. The present invention improves visualisation and handling during the transvaginal examination, providing a more accurate and effective diagnosis.

Description

[0001] TRANSVAGINAL DEVICE FOR IMPROVING EARLY DETECTION SCREENING FOR CERVICAL CANCER RISK

[0002] 5 FIELD OF THE INVENTION

[0003] The present invention relates to the field of medical devices, especially in relation to instruments used in gynecological procedures and other medical procedures that require visualization and access to body cavities.

[0004] 10

[0005] BACKGROUND OF THE INVENTION

[0006] The care of women with cervical cancer continues to be a global public health challenge. The latest available data indicate that in 2020, this cancer was the third leading cause of cancer death among women worldwide, with a mortality rate of 7.3 per 100,000 inhabitants, resulting in 341,831 deaths. In Latin America and Colombia, it is the second leading cause of death in women, with mortality rates of 6.5 and 7.6 per 100,000 inhabitants, respectively (IARC, n.d.). In Latin America and the Caribbean, the cervical cancer mortality rate is three times higher than in North America (Pan American Health Organization, 2016). In Colombia, women aged 15 to 49 are the most affected, resulting in the highest number of Years of Life Lost (YLL) (IARC, n.d.).), and being the leading cause of years of potential life lost (YPLL) due to preventable causes (National Institute of Health & National Health Observatory, 2015).

[0007] 25 In Colombia, cancer outcomes are generated by factors such as lack of access to and low availability of early diagnostic cancer services (Colombian Fund for High-Cost Diseases, High-Cost Account (CAC), 2022), particularly affecting vulnerable women. This can be attributed to a lack of timely diagnosis and treatment (Colombian Fund for High-Cost Diseases, 2022; National Institute of Health & National Health Observatory, 2015). From 2013 to 2017 in Colombia, according to the National Health Observatory, a total of 185,877 deaths from all preventable causes attributable to the health system were recorded, and 3.5% were due to cervical cancer (Colombian Fund for High-Cost Diseases, High-Cost Account (CAC), 2022).

[0008] Cervical cancer care consists of three stages: screening, diagnosis, and treatment. Access to screening varies depending on the availability of tests. In urban areas, in countries like Colombia, conventional or liquid-based cytology is performed on women aged 25 to 29 and on women under 25 with risk factors. For women aged 30 to 65, HPV DNA testing and cytology (interpretation based on HPV DNA results) are mandatory.Conversely, access for rural women is more limited, and visual inspection techniques using acetic acid (VIA) and Lugol's iodine (VILI) are often employed (Resolution 3280 of 2018, Adopting the Technical and Operational Guidelines for the Comprehensive Care Pathway for Health Promotion and Maintenance and the Comprehensive Health Care Pathway for the Maternal and Perinatal Population and Establishing Guidelines for its Operation, 2018). These techniques involve visual interpretation of the cervix by the healthcare provider, increasing the risk of false positives. Despite the fact that screening is the foundation for comprehensive cervical cancer control, access to diagnostic and pathology tests remains limited (National Institute of Health & National Health Observatory, 2015).

[0009] Diagnosis involves a colposcopy, and depending on the results, a biopsy is taken, which is considered the gold standard test. Colposcopy allows for magnified visualization of the cervix; and according to the staging system of the International Federation of Gynecology and Obstetrics (FIGO, 2019), precancerous lesions can be identified, including low- and high-grade lesions (CIN I-II-III) or adenocarcinoma in situ. Performing these procedures requires expensive equipment, which limits their use in resource-constrained settings and rural areas. According to the morbidity and mortality profile in the country, in 2021 55.6% of new cases of cervical cancer were diagnosed in advanced stages (IIB / IVB), and the opportunity for consultation for symptoms or delivery of screening results until the start of treatment was on average 1 14 days (National Cancer Institute (INC), 2022).

[0010] A colposcopy is used to magnify the image of the cervix with a lens device so that a healthcare professional can evaluate the images obtained. In this case, a speculum is required to open the vaginal cavity. However, these professionals must be well-trained to visually determine the presence of abnormalities in the tissue examined to diagnose the potential risk of cancer.

[0011] Regarding other technological developments related to cervical cancer screening and diagnosis, other devices are known:

[0012] This is the case of the device described in patent document US20120157767, which reports a digital system for the detection of cervical cancer with clinical application. The device is inserted into the user's genital cavity and consists of a camera and a light source at its distal end to take photographs of the cervix and its surrounding environment. This device can be used by the user herself or by healthcare professionals.

[0013] Furthermore, patent WO2017083588 discloses a transvaginal apparatus and a method for detecting cervical cancer and tuberculosis, wherein the device comprises an insertable end configured to be inserted into an opening within a user's body and a non-insertable end configured to be outside the opening, a camera, a light source, and a nozzle for releasing a liquid into the opening. The non-insertable end comprises an electronic device configured to store and analyze images captured by the camera. The electronic device is further configured to control the quantity of liquid released through the nozzle into the opening, to validate image quality, and to perform automated image analysis to diagnose a lesion or pathological abnormality within the opening.

[0014] In the prior art, there are some solutions related to the object of the invention. In the patent literature, for example, patent application US20120157767 shows a device for the detection of cervical cancer with clinical application, in which a device is inserted into the user's genital cavity and is composed of a camera and a light source at the distal end in order to take pictures of the cervix and its contour.

[0015] International publication WO2017083588 discloses a transvaginal device and method for detecting cervical cancer and tuberculosis. The device comprises an insertable end configured to be inserted into an opening within a user's body and a non-inserted end configured to remain outside the opening, a camera, a light source, and a nozzle for releasing a liquid into the opening. The non-inserted end includes an electronic device configured to store and analyze images captured by the camera. The electronic device is further configured to control the amount of liquid released through the nozzle into the opening, to validate image quality, and to perform automated image analysis to diagnose a lesion or pathological abnormality within the opening.

[0016] Patent application CN102188228 describes a portable electron microscopy detection technique for cervical cancer prevention, comprising a light source supply circuit system and a microelectronic microcamera system. The microelectronic microcamera is preset and fixed, with zoom capability to obtain a magnified image for use with an electron microscope for sharper imaging. The light source supply circuit controls the required light intensity by adjusting a knob. These two devices are integrated into the front end of a detection tube cavity to complete the acquisition of cervical image data and transmit it to an image display device for user self-diagnosis.

[0017] US patent application US20190150725A1 discloses colposcopes and mammoscopes with curved and flat ends, associated methods, and speculum-free imaging techniques known as inserts. These include a portable endoscopic camera with integrated lights of various types, connected via USB to a computer for visualizing the cervix and linked to an endoscope. Among the inserts, one stands out with an elongated body that defines an internal space, featuring a tapered distal end and a proximal end. This internal space serves as a working channel for forceps, brushes, and for inserting the colposcope. Both devices work well together, although they can also be used separately. While the insert is an alternative to the speculum, the latter still provides a better field of view.

[0018] US patent 10188298B2 discloses a system for directly imaging, diagnosing, and removing abnormal cells in the cervix. It includes a disposable optical speculum, an imaging system with the speculum mechanically assembled and secured, configured to capture a single or multiple images or videos of cells within the target tissue using bright-field or dark-field ring illumination, and a laser module for ablating abnormal cells. Although it is an imaging system for abnormal cells for removal, it is considered more of a diagnostic and treatment system than a screening or early detection system for cervical cancer risk levels.

[0019] The publication of patent application US2022 / 0218318A1 discloses a portable, self-administered gynecological device for women to collect a cervical cell sample for a Pap test without the need for a gynecologist. The device has a protective guide with an upper chamber for an endoscope and a lower chamber for a brush. The endoscope illuminates and views the cervix, while the brush extends to collect cells. A computer enhances visualization and guidance. The device allows for the convenience and privacy of self-Pap testing.

[0020] International patent publication WO2022 / 120212A1 describes a transvaginal device and method for cervical cancer detection. This method uses a probe equipped with an endoscopic camera and a light source at its distal end, along with a proximity sensor to capture images in fixed focus. The system incorporates an image processor that segments the area of ​​interest and displays the results on a screen.

[0021] Utility model patent CO15149171 describes a modification to the design of a conventional speculum. This document addresses the utility model patent, which refers to a disposable vaginal speculum with a two-movement opening: vertical opening and angled opening. The purpose of this modification is to allow the examiner to perform the examination more effectively to visualize the cervix, while minimizing discomfort for the patient. This speculum incorporates a one-handed locking and unlocking mechanism, leaving the other hand free for other procedures. Furthermore, it is made of single-use material to prevent cross-contamination. The patent focuses exclusively on the speculum, without adding any other components.

[0022] Taking into account the aforementioned state of the art, the present invention solves the problem associated with performing gynecological procedures and other medical procedures that require visualization and access to body cavities by means of a speculum-shaped device that improves inspection visibility, incorporating an ergonomically advantageous configuration for both the patient and the health professional performing the examination.

[0023] SUMMARY OF THE INVENTION

[0024] The present invention discloses a transvaginal device for improving examinations for the early detection of cervical cancer risk. This device includes elements that provide two degrees of freedom with precise adjustment and positioning in various directions and angles, significantly improving accessibility and visibility of the area of ​​interest during procedures. This device is particularly suitable for interventions requiring delicate and precise tissue manipulation, allowing the medical professional to make fine adjustments and ensure optimal exposure of the visual field by means of a specially adjusted camera.

[0025] The transvaginal apparatus comprises a base that slides to support a fork pivotally attached to an arm. The arm includes an upper wing portion and a U-shaped structure with parallel members and an adjustment tab. The base has a lower wing portion, a neck, and a handle. The fork has an alignment bar and a ratchet extension with teeth for rotating adjustment of the arm. Furthermore, the base integrates a sleeve with an intermediate elbow that houses an endoscopic camera, connected by wiring to an image processing unit with artificial intelligence, including an adjustable lighting unit, where the invention ensures accuracy and comfort during examinations.

[0026] The device being disclosed is suitable for implementation in cancer prevention services, as it is a portable, disposable, low-cost, and easy-to-operate solution that does not require an internet connection. It allows for the timely detection of cervical cancer risk levels based on artificial intelligence supported by a clinical case-control study. This reduces waiting times, optimizes diagnostic opportunities, and facilitates the initiation of appropriate treatments.

[0027] In the preferred embodiment, the device of the present invention is integrated into an image analysis module based on artificial intelligence algorithms, which can be embedded in a mobile or web application that, in turn, can operate offline or without internet access. This mobile application, through computer-operated instructions, guides the healthcare provider step-by-step through the screening process and provides a response regarding the level of risk associated with cervical cancer; it also allows for tracking the patient's previous screenings.

[0028] BRIEF DESCRIPTION OF THE FIGURES

[0029] To complement the description and to facilitate a better understanding of the technical characteristics of the invention, a set of figures defined as follows is attached to this descriptive document and forms an integral part thereof:

[0030] FIG. 1 A. Isometric view of the transvaginal apparatus in closed position.

[0031] FIG. 1 B. Isometric view of the transvaginal apparatus in angular open position.

[0032] FIG. 2A. Isometric view of the transvaginal apparatus in open angular position and without expansion.

[0033] FIG. 2B. Isometric view of the transvaginal apparatus in the open, angular, and expanded position. FIG. 3. Cross-sectional view of the transvaginal apparatus.

[0034] FIG. 4A. Symmetrical view of the arm.

[0035] FIG. 4B. Side view of the arm.

[0036] FIG. 5A. Symmetrical view of the base.

[0037] FIG. 5B. Side view of the base.

[0038] FIG. 6A. Symmetrical view of the fork.

[0039] FIG. 6B. Side view of the fork.

[0040] FIG. 7A. Isometric view of the intermediate elbow.

[0041] FIG. 7B. Cross-section view of the intermediate elbow.

[0042] DETAILED DESCRIPTION OF THE INVENTION

[0043] The present invention discloses a transvaginal device for improving early detection of cervical cancer risk, incorporating two degrees of freedom that allow for greater flexibility and control during medical procedures. Unlike conventional specula, this device features joints and mechanisms that provide multiple degrees of freedom of movement, enabling the healthcare professional to adjust and position the speculum more precisely within the vaginal cavity, adapting it to the patient's particular anatomy and providing wider access and improved visibility of the area of ​​interest. The invention also describes design features that enhance the device's stability and durability, making it safer and more effective for clinical use.

[0044] The transvaginal device is portable, disposable, and low-cost, with bidirectional opening that allows for adjustment at different heights and angles. It includes a removable endoscopic camera containing an LED illumination unit for capturing images of the cervix. The endoscopic camera connects to a real-time display unit via a wired connection.

[0045] With regard to the figures accompanying this descriptive report, FIG. 1A reveals a transvaginal apparatus (1) with means to improve the examination which includes a base (20) that slides to support a fork (30) to which an arm (10) is articulated.

[0046] The arm (10) has an upper wing portion (11) extending to a U-shaped structure (12) that includes two substantially parallel members (121) extending to a lower section (122) that has an adjustment tab (123).

[0047] The base (20) includes a lower wing portion (21) that extends through a neck (23) to a handle portion (22) into which the fork (30) slides.

[0048] The fork (30) includes an alignment bar (34) that slides in a guide on the handle (22), and also includes a ratchet extension (33) with teeth to secure the position of the arm (10) relative to the pivots (13) in a fixed but rotatably adjustable position, where the pivots (13) are the connection points between the arm (10) and the fork (30).

[0049] FIG. 1B reveals the transvaginal apparatus (1) with means for improving the examination of FIG. 1A, where the rotary position of the arm (10) has been adjusted by means of the adjusting tab (123) against the teeth of the ratchet section (31), allowing an angular opening between the upper wing (11) and the lower wing (21) around the pivot (13), this first degree of rotational freedom allowing the examined cavity to be enlarged in a first manner.

[0050] FIG. 1 B also reveals the sleeve (24) which is fixed, integral and part of the base (20), the sleeve (24) has a substantially tubular shape which allows the internal coupling of an intermediate tubular elbow (40), in which an endoscopic camera (50) with lighting elements (52) is located inside as shown in FIG. 3.

[0051] Figures 2A and 2B reveal the transvaginal apparatus described in the previous figures. Figure 2A shows the apparatus in an open angular position without vertical expansion, while Figure 2B shows the apparatus in an open angular position with vertical expansion. This second degree of translational freedom allows for a second expansion of the examined cavity. The vertical translational movement of the fork (30) and arm (10) occurs together with respect to the base (20). Specifically, the alignment bar (34) and guide members (31) of the fork (30) slide in the guide channels of the base (20), allowing for an additional opening, either vertically or vertically, to improve visibility within the examined cavity.

[0052] Within the context of the present invention, the term “vertical” should be interpreted exclusively in an explanatory and referential manner for the figures of the present invention.

[0053] The transvaginal apparatus (1) which includes the first and second degree of freedom with its means to improve visibility, has sufficient space to fulfill the function as a working channel for inserting swabs or forceps for cleaning, applying contrast medium liquids to the cervix and / or taking samples of the Human Papillomavirus (HPV).

[0054] The upper wing (1 1 ) and lower wing (21 ) are elongated and curved structures designed to fit the patient's anatomy. The surface of the wings is substantially smooth and free of irregularities to minimize patient discomfort and improve hygiene conditions. The wings are rounded and gently contoured to facilitate insertion.

[0055] FIG. 3 reveals a cross-section of the transvaginal apparatus (1), as described in the previous figures, and also shows the angle (3, defined between the wing axis and aof reference that is contained in a plane that passes through the upper edge of the lower wing (21 ) and the central axis e c of reference that passes substantially through the center of the sleeve (24) or the center of the first tubular portion of the intermediate elbow (40) that is inserted into the sleeve (24) or the center of the endoscopic chamber (50).

[0056] The angle [3 is defined in the range between 5 o at 20°, preferably between 6 o at 15° and even more preferable among 8 oAt 12°. This camera position (60) improves comfort during the examination for both the patient and the healthcare professional performing the examination, and also improves the quality of the images acquired for subsequent diagnostic processing. The fork (30) with a ratchet extension (33) or ratchet lock allows the device's wings to be held in a fixed, open position during the examination. When locked by a U-shaped structure (12), the ratchet extension (33) ensures that the upper (11) and lower (21) wings do not close accidentally, providing the physician with a stable and clear view of the vaginal canal and cervix. The toothed ratchet facilitates precise adjustment of the opening as needed for patient comfort and the purpose of the examination.

[0057] The endoscopic camera (50) has a fixed focus distance between the lens and the target that is selected in the range between 60mm to 80mm, more preferably between 65mm to 75mm and even more preferably between 68mm to 72mm, where particular focus distance improves the quality of the acquired images, for applications where accuracy and repeatability are essential.

[0058] The endoscopic camera (50) is located inside the intermediate elbow (40) and this is coupled to the sleeve (24), in this way the endoscopic camera (50) is fixed to the base (20), and also the endoscopic camera (50) allows to be conveniently removable.

[0059] The removable endoscopic camera (50) has an intensity-adjustable lighting unit (52) by means of a potentiometer, which allows adjusting the amount of light for observation and image capture of the cervix, where the lighting unit (52) is preferably of the LED type.

[0060] The endoscopic camera (50) has a wired connection (51) to an AI-powered image processing and diagnostic unit. This unit sends images to an AI-based image analysis module embedded in a mobile application that can operate offline or without internet access. The AI-powered image processing and diagnostic unit includes computer-readable media or software within the mobile and web application. This software guides the healthcare provider step-by-step through the screening process and sends the images of the cervix to the AI ​​module. The software provides a response in less than five seconds regarding the risk level associated with cervical cancer. It also allows for tracking previous screenings and retraining the AI ​​module.

[0061] In the preferred embodiment, the transvaginal apparatus is preferably made of polystyrene material.

[0062] FIG. 4A and 4B show the arm (10) including the upper wing (11) extending to the U-shaped structure (12) having two substantially parallel members (121) extending to a lower section (122) having and extending to an adjustment flange (123).

[0063] FIG. 5A and 5B show the base (20) which includes a lower wing (11) that extends to a handle (22) connected by a neck (23), over the lower wing (11) is integrated or fixed a sleeve (24) which houses part of the intermediate elbow (40) as shown in FIG. 7A and 7B.

[0064] The handle (22) includes slots (231) where the fork guides (31 1) are housed as shown in FIG. 6A and 6B, and also includes a hooking surface (222).

[0065] The neck (23) includes a slotted cavity (221) where the alignment guides (341) of the alignment bar (34) shown in FIG. 6A and 6B are housed.

[0066] Figures 6A and 6B show the fork (30), which includes two substantially parallel guide members (31) extending and joining at a cross portion (32). It also includes an alignment bar (34) extending from a point adjacent to the junction of one of the guide members (31) and the cross portion (32). The guide members (31) and the alignment bar (34) are substantially parallel to each other. Furthermore, the guide members (31) and the alignment bar (34) are substantially perpendicular to the cross portion (32). The ratchet extension (33) protrudes in a curved shape from the cross portion (32).

[0067] The guide members (31) include guide fittings (311) that slide and substantially match the grooves (231), as shown in FIG. 5A. The alignment bar (34) includes alignment guides (341) that slide and substantially match the grooved cavity (221), also as shown in FIG. 5A. The alignment bar (34) slides in a guide cavity (221) located in the handle (22). In addition, the fork includes a ratchet extension (33) with teeth that allow the rotational position of the arm (10) to be adjusted relative to the pivot point of the pivots (13). The pivots (13) are the connection points between the arm (10) and the fork (30) and engage in the holes (312). The male-female coupling between the pivots (13) and the holes (312) can be interchanged with female-male according to the particular design needs.

[0068] The alignment bar (34) further includes a gripping surface (342) that allows the user to move the fork (30) with a translational motion, and further includes a clip contact (343) with clip release means (344), wherein the clip contact (343) allows it to be adjusted and locked against the engagement surface (222) and wherein the clip release means (344) are pressed by the operator of the apparatus to release the engagement between the clip contact (343) and the engagement surface (222) as shown in FIG. 5A.

[0069] Figures 7A and 7B reveal the intermediate elbow (40) having a first tubular portion (41) extending to a second tubular portion (42) connected by an intermediate curved section (43); within the first tubular section (41) in the first channel (411) the endoscopic camera (50) is located as shown in Figure 3; the first channel (411) extends and connects to the second channel (421); within the second channel (421) the wiring (51) of the endoscopic camera (50) is routed as shown in Figure 3, thus improving the handling of the wiring in the transvaginal apparatus, routing the wiring (51) in the best possible way to reduce discomfort or obstruction in its manipulation.

[0070] The device's bidirectional opening configuration offers a significant improvement, allowing for greater amplitude and more precise adjustment during the examination. Furthermore, the configuration of the endoscopic camera (50), fixed to the base (20) located within the intermediate elbow (40) coupled to the sheath (24), enables the capture of detailed images of the vaginal canal and cervix, significantly enhancing the diagnostic and documentation capabilities of the procedure. Although the present invention has been described with the preferred embodiments shown, it is understood that modifications and variations that preserve the spirit and scope of this invention fall within the scope of the appended claims.

[0071] References

[0072] • Colombian Fund for High-Cost Diseases. (2022). Effect of breast and cervical cancer screening on mortality, early diagnosis, and TNM staging: An ecological approach. https: / / cuentadealtocosto.org / publicaciones / informe-especial-efecto-de-la-tamizacion-en-cancer-de-mama-y-de-cervix / .

[0073] • Colombian Fund for High Cost Diseases, High Cost Account (CAC). (2022). Cancer situation in the adult population served by the SGSSS of Colombia, 2021.

[0074] • IARC. (n.d.). Global Cancer Observatory. Retrieved June 12, 2024, from https: / / gco.iarc.fr /

[0075] • National Cancer Institute (INC). (2022). Statistical Yearbook 2021 [Yearbook].

[0076] • National Institute of Health, & National Health Observatory. (2015). National Report on Social Inequalities in Health in Colombia, (pp. 1-366).

[0077] • Pan American Health Organization & Pan American Health Organization. (2016). Manual for Monitoring Health Inequalities, with special emphasis on low- and middle-income countries. https: / / iris.paho.Org / handle / 10665.2 / 3121 1 .

[0078] • Resolution 3280 of 2018, By which the Technical and Operational Guidelines of the Comprehensive Care Route for the Promotion and Maintenance of Health and the Comprehensive Health Care Route for the Maternal Perinatal Population are adopted and the Guidelines for its operation are established, 3280 Resolution (2018).

Claims

CLAIMS 1. A transvaginal apparatus (1) with means for improving the examination comprising: a base (20) that slideably supports a fork (30) to which an arm (10) is articulated by means of pivots (13); the arm (10) includes an upper wing portion (11) extending to a U-shaped structure (12) that includes two parallel members (121) extending to a lower section (122) having an adjustment flange (123); the base (20) includes a lower wing portion (21) extending by means of a neck (23) to a handle portion (22);and the fork (30) includes an alignment bar (34) that slides on the alignment guides (341) within the handle (22) in a slotted cavity (221), and also includes a ratchet extension (33) with teeth to secure the position of the arm (10) relative to the pivots (13) in a fixed but rotatably adjustable position, where the pivots (13) are the connection points between the arm (10) and the fork (30).

2. The transvaginal apparatus according to claim 1, characterized in that it further includes a sheath (24) that is fixed to the base (20).

3. The transvaginal apparatus according to claim 2, characterized in that it further includes an intermediate elbow (40) coupled to the sheath (24).

4. The transvaginal apparatus according to claim 3, characterized in that it further includes an endoscopic camera (50) that is fitted inside the intermediate elbow (40).

5. The transvaginal apparatus according to claim 4, characterized in that the endoscopic camera (50) is connected by means of wiring (51) to an image processing and diagnostic unit implemented with artificial intelligence.

6. The transvaginal apparatus according to claim 4, characterized in that the fixed lens endoscopic camera (50) has a focusing distance in the range between 60mm and 80mm.

7. The transvaginal apparatus according to claim 4, characterized in that the endoscopic camera (50) includes an adjustable lighting unit (52).

8. The transvaginal apparatus according to claim 5, characterized in that the wiring (51) passes through the intermediate elbow (40).

9. The transvaginal apparatus according to claim 2, characterized in that the sheath (24) has an angle [3 within the range between 5 o at 20°.

10. The transvaginal apparatus according to claim 1, characterized in that it is made of polystyrene material.

Images