NON-VAGINAL EXAMINATION CERVICAL DILATATION MEASUREMENT SYSTEM AND METHOD
Patent Information
- Application Number
- TR202613558
- Authority / Receiving Office
- TR · TR
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2026-08-11
- Publication Date
- 2026-09-21
Smart Images
Figure 00000018_0000
Abstract
Description
1 TARIFF NON-VAGINAL EXAMINATION CERVICAL DILATATION MEASUREMENT SYSTEM AND METHOD Technical Area The invention demonstrates that cervical dilation during labor is entirely dependent on vaginal palpation. without, objectively 5 using a non-invasive or minimally invasive measurement principle. It is related to evaluation. The invention specifically enables the collection of three-dimensional morphological data relating to cervical opening, processing of collected data and using an artificial intelligence-powered algorithm enabling the conversion to standardized cervical dilation values; thus It reduces observer-dependent differences in assessment, is measurable, repeatable, and 10 Generating digitized results, supporting patient comfort, and providing clinical decision support. a cervical dilation measurement system that provides objective data on its mechanisms and It is related to the method. State of the Art Today, in the clinical management of normal labor, the correct cervical dilation is considered to be 15. and reliable assessment, monitoring of the progress of the action, intervention in terms of making timely decisions and ensuring maternal-fetal safety It is considered a fundamental parameter. In current obstetric practice, the most known method for measuring cervical dilation is... The common technique involves a healthcare professional inserting 20 needles into the vaginal canal using their fingers. By entering the data, the cervical os opening can be estimated in finger widths or centimeters. It is a vaginal examination method based on the observation of labor. This method allows for the examination of the vaginal opening during childbirth. It is repeated at certain intervals from the beginning and the findings obtained depending on the stage of labor, whether oxytocin supplementation is needed, or It forms the basis for critical clinical decisions, including the decision for a cesarean section. 25 However, this method, by its very nature, depends entirely on the sensory perception of healthcare personnel and It is a highly subjective evaluation as it is based on professional experience. It is a tool. It is performed on the same patient simultaneously by different observers. Even during examinations, clinically significant differences can occur between measurements. This interobserver variability is well-defined in the literature, particularly in the 30s of labor. 2 making it difficult to accurately assess the dilation rate in the active phase, unnecessary This can lead to interventions or delays in intervention. The invasive nature of the method, however, brings with it another set of significant clinical problems. Vaginal examination involves direct manual contact with the patient's genital area. Because it requires it, it creates pain, significant anxiety, and a feeling of privacy violation for many women. 5 It is perceived as a psychosocial stressor. This situation affects the quality of the birth experience. not only does it negatively affect the fetus passing through the birth canal, It also indirectly leads to negative effects through maternal stress responses. It can open. In addition, vaginal openings, which are frequently repeated during labor. Digital rectal examinations disrupt the normal vaginal flora and increase the risk of ascending infections by 10%. This leads to a significant increase, especially in premature membrane rupture. in cases such as prolonged labor, chorioamnionitis and neonatal sepsis The risk of developing serious infectious complications from unnecessary or frequently repeated vaginal procedures. It is directly related to physical examinations. This risk of infection affects both the mother and the child. This poses a serious risk in terms of neonatal morbidity and mortality, and health 15 It also creates a significant cost burden on the system. With the current technique, apart from vaginal examination, there are no known methods for evaluating cervical dilation. While several alternative methods exist, each of these methods has different limitations. It carries. Ultrasonographic cervical evaluation is non-invasive because of its nature. Although it may seem advantageous, direct and quantitative dilation of the cervical canal is 20 Its measurement capacity is limited, especially regarding the position of the fetal head during the active phase of labor. Therefore, it is often not possible to obtain a clear image. Electronics Cervical dilation monitors, however, require invasive probes and compromise patient comfort. It has similar disadvantages to vaginal examination in terms of infection risk, and also... It also involves additional technical problems such as equipment cost and calibration accuracy. 25 Therefore, vaginal examination is used in obstetric practice because of its practicality and low cost. Although still considered the gold standard, as detailed above subjectivity, patient comfort, psychosocial impact, infection risk, and inter-observer factors. It retains its fundamental limitations, such as differences. As a result of research on this topic, the following systems were encountered: 30 Patent document number CN117158882A describes a vaginal examination device. It is stated that the system consists of a lower wing component, and a movable element attached to this lower wing component. 3 an upper wing component mounted in this manner and an image acquisition device It includes a lower wing component, a coupling section, and a component attached to this coupling section. The lower wing consists of a lower wing component, while the upper wing component is a thrust piece and a top attached to this thrust piece. It consists of a wing. The thrust part slides and rotates over the gripping section, moving upwards. Adjusting the distance between the wing and the lower wing, and the opening angle. 5 It provides. The fundamental innovation of the invention is that the user holds the gripping section while... a button positioned so that it can be touched by sliding the thumb upwards with a pusher piece arranged to remain in the area and below this key area, Solving the problem of accidental button presses on existing devices The aim is to use a speculum (vaginal 10) for visual examination of the vaginal walls. while focusing on the structure of the speculum, the dilation of the cervical os during labor It does not aim to evaluate using a quantitative and non-subjective method. Patent document number CN208388583U describes a field of obstetrics and gynecology. This refers to a fully equipped vaginal examination device for diagnosing diseases. 15 The invention consists of an inspection guide tube, an inflatable balloon, and a handle. The inspection guide tube consists of a telescopic section, extending from the bottom to the top. It includes a transition section and a probe section. It surrounds the outside of the telescopic section. The inflatable balloon is connected to an external inflation mechanism. In the transition section, the temperature... The probe section has a recess containing the sensor, pH sensor and odor sensor, while the probe section is 20 The system includes a camera, an LED light ring, and a microarray pressure sensor. By combining visual, tactile, olfactory, and physiological parameters, a comprehensive examination is conducted inside the vagina. It enables examination. The system analyzes multiple physiological parameters. when measuring, it is especially important to determine the amount of dilation in three dimensions and numerically. It is unable to state its principle. 25 Patent document number CN208861564U describes a posterior vaginal fornix puncture. The model described is one of monitoring, examination, and guidance. The invention relates to clinical obstetrics and gynecology. and in the field of gynecology education, a model body, a model placed on that body A structure consisting of thigh fixation pins and model thighs attached to these pins. 30 It has a model body made of rubber material, which provides a tactile feel. It increases its realism. The system improves the skills of posterior vaginal fornix puncture. It provides a simulation platform for training and evaluation. The system is a It is designed as an educational tool and a real-time clinical decision support mechanism. It does not function as such. 35 4 Patent document number CN119257644A describes a gynecological clinical vaginal secretion. The sampling device is being discussed. The system includes a sampling hold section, this hold section... two curved connecting wings fixed to one end of the section and at the ends of these wings It includes a sampling mechanism along with a reinforcement block. Sampling 5 Its mechanism allows it to reach deep parts of the vagina, inaccessible by traditional methods. While enabling the collection of samples, vaginal pressure is applied to an inflatable tube. It allows secretions to be collected in a sampling container. The system is a While it is a biological sample collection tool, it is a quantitative tool for monitoring the progress of labor. It does not function as a measurement system that generates data. 10 Patent document number CN204336893U describes a new type of multifunctional physical examination device. The auxiliary device is mentioned. The system consists of a hammer body and a percussion hammer. The head consists of a hammer handle and a grip. At the lower end of the grip is a The head has a hammer handle at its upper end, and the body of the hammer is located at the end of the hammer handle. 15 The hammer body has a percussion hammer head at one end and an LED light head at the other. It has a pain examination needle at the top. The handle is hollow, At the end of the cap underneath is a tactile examination brush, and inside this brush is a The system includes a cotton swab for olfactory examination, a percussion hammer, and pain relief equipment. A device integrating an examination needle, touch brush, scent stick, and flashlight. 20 It offers a system that combines neurological and sensory examination tools. A solution specifically developed for quantifying an obstetric parameter. It does not offer. Patent document number CN118402822A describes a gynecological examination specimen as 25 The text refers to a collection device. The system consists of a first sheath, and to the other end of this sheath... a connected sampling mechanism and this mechanism by piercing the second and third casings It is formed by attaching it to a flap. The cotton swab initially has a third sheath. It is hidden inside and once the device is placed in the desired position inside the vagina, a The cotton swab is removed by pressing the button, and after sampling is complete, 30 When the button is released, the retractable wand automatically retracts. This allows the cotton swab to be removed. the stick touching other areas during insertion and removal from the vagina, for example This prevents contamination of biological samples. The system, a comparable invention, while aiming for contamination-free collection, for objective monitoring of labor. It is not intended to collect data via sterile sensors. 35 Patent document number CN1200636C describes a vaginal speculum. The system is mentioned as being used for the internal examination of a body cavity such as the vagina. It is a structure that has at least two spoons. These spoons are connected to each other via a hinged pin. They are connected and in a closed position where the spoons touch each other, with 5 evenly spaced intervals. It is able to move between an expanded position from which it was separated. The system also, at least one operating arm that remains outside the body cavity during use, and that arm It includes a body support that works in conjunction with the spoons to allow them to expand. One of the spoons forms a U-shaped body, the outer part of which is the vagina. It is shaped to fit in the mouth. While the system is an imaging access tool, 10 independent method that quantifies cervical dilation without manual palpation It does not include a diagnostic system. Patent document number CN202976643U describes a woman undergoing a rectal examination. The model is being discussed. The system is a medical training model, consisting of a hip model and a 15 The anorectal module consists of a vagina, a uterine module, and a base. (Hip) The model extends from the navel to the upper half of the knee, requiring a lithotomy. It is designed to leave the anus exposed in this position. The anorectal module, vagina and the uterine module is positioned anatomically correctly within the hip model. It is located in and the symphysis pubis region can be separated for the replacement of modules. 20 The system offers a passive structure for teaching rectal examination skills, while active sensors... and does not include a solution that generates real-time data using algorithms. In document number CN202454152U, a gynecological examination model is described. It is stated that the system is basically based on a lower body model of an adult woman. It is formed and extends from the abdominal region to the upper third of the thigh. The model is in the lithotomy position, suitable for a standard gynecological examination, with the device inserted into the pelvis. It includes normal and abnormal uterus and its appendages, which can be implanted. Ovaries and Hydrosalpinx is attached to inflatable balloons, and its size is adjusted by injected air. It is adjustable. The model is suitable for colposcopy examination, rectal examination, cervical and vaginal examinations. training in various gynecological skills such as smear tests, bimagnetic examinations, and triage examinations. This allows the system to simulate anatomical structures that can be palpated. an objective measurement approach that completely eliminates the need for palpation It does not offer. 35 6 Patent document number CN202397524U describes a uterine examination sampler. The system is described as consisting of a hollow sampling tube, and a probe placed inside this tube. A probe consists of a handle at one end and a brush-like probe head at the other. It consists of. The probe has a length measurement scale. During use, The probe is first inserted into the cervical canal, then the probe head is attached using the handle. 5 A sample is taken by extending a sampling tube into the uterus, and the sampling tube... withdrawn from the container to collect the sample without touching the cervix and vagina. The system provides endometrial or cervical cytological samples. While it is a device aimed at contamination-free collection, during childbirth A measurement system for objectively determining the diameter of the cervical os. 10 It does not include. Patent document number CN117137445A describes a vaginal examination device. It is mentioned that the system consists of the first, second, third, and fourth internal tubes and these tubes... It contains a multi-stage telescopic mechanism. Inside the first internal tube, there are 15 There is a rotating plate attached to a mounting tube, and the outside of this rotating plate A touch bubble is attached to one surface, and a connecting rod is attached to the other. The invention relates to a touch balloon that connects the cervical os to the vaginal fornix, between the vagina. by allowing for extension and adjustment of position, it will replace the fingers. This system allows for palpation of the vaginal fornix in this way. The system is manual 20 While it is a tool that simulates palpation, quantitative palpation eliminates palpation entirely. It does not include a measurement system. Patent document number CN208954463U describes the extraction of a gynecological secretion. The text refers to a training simulation model. The system's exterior resembles a real human body. It is a training model that simulates the elasticity and tactile sensation of tissue, a model cavity and a simulated sponge material placed inside that cavity It consists of the uterus. The model represents the lower abdomen and pelvis region of an adult female. These include vaginal secretion sampling, observation and diagnosis of cervical lesions. It is used for practicing skills. The system is a passive training tool, and the actual 30 It fails to offer an active medical device solution that generates real-time clinical data. Patent document number RU2459205C1 describes the diagnosis of nonspecific vulvovaginitis in girls. A method is being described for this. The system involves bacterioscopic analysis of vaginal secretions. Along with the physical examination, cytological analysis of palpable smears of vaginal secretions was performed. 35 7 This includes the examination of the smears, with the urethra and vaginal vestibule exposed on the slide. It is obtained by pressing firmly on its surface. Leukocytes, eosinophils and segmented cells. Neutrophil count is used to diagnose vaginitis of allergic, viral, or bacterial etiology. It is installed. The system is a laboratory diagnostic method, used during labor. The measurement system used cannot provide a solution. 5 Patent document number MX2021015040A describes a procedure for a pelvic-uterine examination. An atraumatic device is being discussed. The system has a friction coefficient of 0.15 to 0.32. among them, exhibiting minimal adhesion and compatible with biological tissues, preferably It consists of a series of parts made of thermoplastic elastomer. The device is vaginal 10 with atraumatic edges and convex additions on the elements placed in the cavity It has a gradual opening mechanism. This allows it to adhere to the vaginal walls. by creating high and low pressure moments, without damaging the tissue and the patient It reduces discomfort and allows for examination. The system examines the vaginal walls. while optimizing its mechanical separation, this type of separation process becomes unnecessary. 15 It does not offer a non-invasive or minimally invasive measurement principle. Patent document number CN209770331U describes a field of obstetrics and gynecology. The speculum is mentioned. The system consists of a fuselage and an upper wing on this fuselage. And along with a lower wing, there is an upper wing stalk at one end of the upper wing. Upper 20 The upper part of the wing stalk features a viewing hole, while the lower part has a capacitive touchscreen. The system includes a sensor switch and a battery. The system provides lighting during inspection. It includes an LED light ring that provides capacitive touch. It is controlled by a sensor switch. Additionally, there are markings on the upper and lower wings for the patient. Medical silicone 25 that does not cause a feeling of coldness and protects the vaginal walls from injury. The system includes protective covers made of the same material. The vaginal speculum enhances patient comfort. and includes improvements aimed at increasing ease of use, while replacing vaginal examination. It does not offer an AI-powered measurement system that can detect this. In document number CN201939324U, it is stated that 30 from an integrated digital birth monitor The system is described as consisting of a duckbill-type speculum, a handle, and a colored speculum. The device consists of a camera, a pressure sensor assembly, a computer, and a cushion. A color camera and pressure sensor assembly is placed inside the handle. The invention, degree of cervical os dilation, fetal head descent level, fetal position changes, and fetal head descent thrust force related to birth power, etc., the progress of labor 35 8 It enables the digital monitoring of key parameters reflecting this. In this way, subjective evaluation mode of traditional vaginal palpation examination and traditional The indirect monitoring mode of the abdominal wall pressure sensors is being changed. The system is a Using a camera and pressure sensor integrated into the speculum, vaginal examination is performed. Alternatively, a less invasive or completely non-invasive approach 5 It does not offer. Patent document number CN201905879U describes a discrete type digital birth monitor. The system is described as consisting of a duckbill-type speculum, a color camera, and a pressure device. The sensing device consists of a computer and a cushion. The system targets the cervical os 10. degree of dilation, fetal head descent level, fetal position changes, and birth. Digital monitoring of parameters such as fetal head descent thrust force depending on power. It provides a subjective assessment of traditional vaginal palpation examination. It changes the mode and the indirect monitoring mode of the abdominal wall pressure sensors. The system works with a camera and sensors placed inside a speculum, and the measurement is 15 an artificial system that works integrated with sterile sensors or non-invasive imaging It has an intelligent algorithm and is particularly effective at reducing or eliminating the need for vaginal examination. It does not include a solution such as offering an approach to eliminate it. Patent document number CN201847663U describes 20 digital birth monitors. The system is described as consisting of a duckbill-type speculum, a color camera, and a digital device. The push-pull force meter consists of a computer and a stand. Duckbill type. The speculum can be connected reversibly with a digital push-pull force gauge. It can also be connected to a color camera in a reversible manner. The computer is connected to the camera via a cable, while the digital push-pull force meter is 25. The system connects to the computer via a USB cable. The system performs cervical os dilation and fetal head stimulation. digital monitoring of parameters such as descent, fetal position and birth force strength by providing a subjective assessment mode for traditional vaginal palpation examination and It changes the indirect monitoring mode of the abdominal wall pressure sensors. The system, In the assessment of cervical dilation, speculum and separate sensors are used. 30 It is based on an artificial intelligence-supported evaluation algorithm and three-dimensional measurement. It does not include the integrated use of the model and sterile sensor technology, therefore cervical dilation in a holistic, standardized, objective and non-invasive manner. It does not offer a system architecture for its evaluation. 35 9 Studies have shown that cervical dilation is used in the clinical management of labor. Current techniques for evaluation appear to have significant limitations. In known systems, cervical dilation measurement is essentially done with the healthcare professional's fingers. It is based on the manual vaginal examination method, and this method is entirely... Because it depends on the user's experience and sensory perception, it is highly subjective. 5 It is an assessment tool and clinical evaluation among different observers on the same patient. Significant differences can arise. In the current technique, in addition to vaginal examination, cervical examination is also performed. Although there are some systems developed to assess dilation, these Most of these systems involve vaginal speculums, which mechanically insert devices into the vaginal walls. It is based on invasive devices that differentiate them; such devices have 10 integrated into them. imaging of the cervical region via cameras or pressure sensors, or Although it allows for the indirect measurement of dilation, it essentially still does not involve a passage into the vaginal cavity. This requires the placement of the device, which compromises patient comfort and privacy. The disadvantages of vaginal examination, in terms of infection risk, are largely similar. It carries. In addition, some existing birth monitoring systems detect cervical 15 camera and force sensors placed inside a speculum to measure dilation However, the accuracy of these systems depends on the positioning of the sensor and This varies depending on the user's ability to position the device correctly. These devices demonstrate a three-dimensional view of the cervical os opening, and most of these devices also provide this view. It provides point or two-dimensional measurements, not morphological data. Again, the existing 20 In technique, inflatable balloon mechanisms for vaginal fornix palpation, vaginal Sampling tubes for secretion sampling or simulation models for training purposes. There are various devices available, but none of these devices can be used during childbirth. cervical dilation is an objective, repeatable, quantitative, and observer-independent test. It does not offer a direct solution to the problem of measuring in this way. The current technique has 25... All these limitations make subjective manual palpation or invasive speculum-based methods irrelevant. not based on measurements, causing minimal discomfort to the patient, and reducing the risk of infection. an innovative solution that does not increase efficiency and produces consistent results regardless of the user. This clearly demonstrates the need for a cervical dilation measurement system. In conclusion, due to the negative aspects described above and the current solutions regarding issue 30 Due to its shortcomings, an improvement is needed in the relevant technical field. It has been made. Purpose of the Invention The invention was created by drawing inspiration from existing situations and overcoming the aforementioned drawbacks. It aims to solve the problem. The main purpose of the invention is to improve cervical dilation during childbirth. The subjectivity inherent in the vaginal examination method used in the evaluation is 5 and to offer a fundamental solution to the problem of high discrepancies between observers. In this way, Regardless of the experience of healthcare personnel, consistent and repeatable in every case. and by obtaining reliable measurement results, uncertainties in the clinical decision-making process It is eliminated. Another aim of the invention is to reduce maternal discomfort caused by the invasive nature of vaginal examination. The aim is to eliminate comfort problems and feelings of privacy violation. The subject of the invention is the system. It works integrated with sterile sensor technology or non-invasive imaging units. Thanks to this, the need for repeated manual contact with the patient's vaginal canal is reduced, or completely eliminated, thus improving the quality of the birthing experience and the patient Psychosocial well-being is preserved. 15 Another aim of the invention is to reduce the reliance on unnecessary or frequently repeated vaginal examinations. The aim is to minimize the risk of ascending infection developing as a result of cervical dilation. The measurement is performed using a non-invasive or minimally invasive method, vaginal. by preventing disruption of the flora, especially in cases of early membrane rupture or prolonged inflammation. serious infectious diseases such as chorioamnionitis and neonatal sepsis during labor 20 It helps prevent complications. Another aim of the invention is to provide three-dimensional morphological data for cervical dilation measurement. The aim is to enable this to be done quantitatively based on artificial intelligence. Thanks to this data processed with evaluation algorithms, the two existing techniques... a comprehensive and precise measurement that cannot be provided by 25-dimensional or point measurement methods Dilation analysis is provided so that the progress of labor can be more accurately assessed. It is monitored. Another aim of the invention is to create a standardized solution that can be easily integrated into clinical practice. and to offer a measurement system that produces reliable results independently of the user. In this way, the existing 30 for monitoring labor in healthcare institutions 11 while contributing to the digital transformation of protocols, health This also reduces the workload and training needs of the staff. Another aim of the invention is to provide treatment, especially during the active phase of labor and intervention. in situations where decisions are critical, such as the decision to take oxytocin supplements or perform a cesarean section. The aim is to ensure that important clinical decisions are made based on more objective data. The current 5 The numerical and repeatable dilation values produced by the system eliminate unnecessary medical issues. This allows for the prevention of interventions and safer management of childbirth. He recognizes. Another aim of the invention is to prioritize patient comfort and safety in the field of obstetrics. The goal is to contribute to the formation of a new care paradigm. Non-invasive or 10 Thanks to its minimally invasive measurement principle, it eliminates the problems created by the traditional vaginal palpation method. By eliminating disadvantages such as pain, anxiety, and the risk of infection, it becomes a women-friendly environment. Leadership is provided in improving maternity services. To achieve the purposes described above, the invention involves a device used during childbirth. Measurement of the cervical os opening in the patient's cervix and cervical dilation of 15 It is a cervical dilation measurement system for evaluation. Accordingly, the system; Three-dimensional morphological data regarding cervical os patency were obtained under sterile conditions. a system that collects data and operates according to the principle of non-invasive or minimally invasive measurement. sensor unit, processing the raw morphological data collected by the aforementioned sensor unit, 20 noise removal and digitization, and data with the aforementioned sensor unit. a data collection and processing module that enables communication, digitized data processed by the aforementioned data collection and processing module standardized and quantitative analysis by analyzing three-dimensional morphological data. a trained artificial neural network that converts cervical dilation values 25 an artificial intelligence processing unit with its architecture, Quantitative cervical data generated by the aforementioned artificial intelligence processing unit dilation values, changes in these values over time, and visualizing clinical decision support data regarding the progression of labor a display and user interaction unit that presents to the user, 30 the aforementioned sensor unit, data collection and processing module, artificial intelligence the energy needs of the processing unit and the display and user interaction unit a power supply that meets 12 It includes. The invention also refers to the cervical os in a patient's cervix during labor. a cervical examination to measure the opening and assess cervical dilation It also includes the dilation measurement method. Accordingly, the method is; 5 Determining the cervical region where the measurement will be performed and the sensor positioning of the unit toward the cervical os opening, Three-dimensional information regarding cervical os opening can be obtained via the aforementioned sensor unit. Morphological data were collected under sterile conditions, using non-invasive or minimally invasive methods. Collection according to the measurement principle, 10 raw morphological data collected by the aforementioned sensor unit to be sent to the collection and processing module, Raw morphological data are collected and processed by the aforementioned data collection and processing module. processing, noise removal and digitization, An artificial intelligence process processes and digitizes three-dimensional morphological data. 15 transfer to the unit, trained artificial neural network located in the aforementioned artificial intelligence processing unit Analysis of three-dimensional morphological data and cervical using architecture standardized quantitative dilation values expressing os opening production, 20 The quantitative dilation values produced are not comparable to the quantitative values obtained in previous measurements. Cervical dilation over time is compared with dilation values. determining the change, the quantitative dilation values mentioned, their change over time, and Clinical decision support data regarding the progression of labor through imaging and 25 forwarded to the user interaction unit. Quantitative analysis through the aforementioned display and user interaction unit dilation values, changes in these values over time, and clinical Visualizing and presenting decision support data to the user. During the measurement period, the sensor unit, the data acquisition and processing module, and the artificial 30 energy for the intelligence processing unit and the display and user interaction unit its needs are met by the power supply It includes the steps involved in the process. 13 The structural and characteristic features and all the advantages of the invention are given in the figures below. This becomes clearer thanks to the detailed explanation written with references to these figures. This will be understood as such, and therefore the evaluation will also take these forms and detailed explanations into account. This should be done taking that into consideration. Figures that will help understand the invention. Figure 1 shows a schematic representation of the system that is the subject of the invention. Explanation of Part References 1. Patient 2. Sensor unit 10 3. Data collection and processing module 4. Artificial intelligence processing unit 5. Display and user interaction unit 6. Power supply Detailed Description of the Invention 15 This detailed explanation describes the preferred system and method for the invention. Their structures are explained solely to facilitate a better understanding of the subject. The invention describes the cervical os in the cervix (1.1) of a patient (1) during labor. a cervical examination to measure the opening and assess cervical dilation It is a dilation measurement system. Figure 1 shows a schematic view of the system that is the subject of the invention. 20 This is provided. Accordingly, the system provides a three-dimensional morphological view of the cervical os opening. data collected under sterile conditions, based on non-invasive or minimally invasive measurement principles. According to the sensor unit (2) which operates, the raw materials collected by the aforementioned sensor unit (2) the aforementioned sensor processes, denoises, and digitizes morphological data. a data collection and processing module (3) that provides data communication with unit (2), mentioned 25 Digitized three-dimensional processed by the data collection and processing module (3) Standardized and quantitative cervical dilation by analyzing morphological data. an artificial intelligence with a trained artificial neural network architecture that converts values into tangible results 14 The processing unit (4) is the quantitative data produced by the aforementioned artificial intelligence processing unit (4). cervical dilation values, changes in these values over time, and visualizing clinical decision support data regarding the progression of labor a display and user interaction unit (5) that presents to the user, the mentioned sensor unit (2), data collection and processing module (3), artificial intelligence processing unit (4) and 5 a power supply that meets the energy needs of the display and user interaction unit (5) It includes source (6). The subject of the invention is the objective and quantitative assessment of cervical dilation during childbirth. It is a three-dimensional measurement system that enables evaluation, and its working principle is non-invasive. or morphological data collected via non-invasive methods and an AI-assisted process It is based on analysis by the unit. The system starts labor on patient (1), and the aforementioned Patient (1) By determining the cervix (1.1) region on which the measurement procedure will be applied, 15 is activated and at this stage the sensor unit (2) is located inside the aforementioned cervix (1.1) It is directed toward the cervical os opening. The sensor unit (2) is placed under sterile conditions and working on an invasive or non-invasive principle, within the mentioned cervix (1.1) It begins collecting three-dimensional morphological data of the cervical os opening in real-time. The collected raw morphological data are instantly transmitted to the data collection and processing module (3). and the mentioned data collection and processing module (3), from the mentioned sensor unit (2) processing this incoming data by removing noise and digitizing it. It performs. The processed and digitized three-dimensional morphological data, more then it is transferred to the artificial intelligence processing unit (4). 25 Using the trained artificial neural network architecture within the artificial intelligence processing unit (4) It analyzes this data; as a result of the analysis, it is completely free from subjective evaluations. It produces independent, standardized, and quantitative dilation values. This quantitative The values are the numerical expression of the cervical os opening in millimeters or centimeters. 30 and also the rate of change compared with previous measurements. It includes. This data, generated by the artificial intelligence processing unit (4), includes imaging and is transmitted to the user interaction unit (5) and the aforementioned viewing and user interaction unit (5), these quantitative dilation values, their change over time and birth by visualizing clinical decision support data regarding the progress of the action to the user presents. Throughout the entire operation process of the system, the sensor unit (2) collects and processes data. module (3), artificial intelligence processing unit (4) and display and user interaction unit 5 (5) energy needs are met continuously by the power supply (6). The mentioned power source (6), in a way that will allow portable or fixed use of the system It is structured.
Claims
16 REQUESTS 1. During labor, the cervical os (1.1) in the cervix of a patient (1) a cervical examination to measure the opening and assess cervical dilation It is a dilation measurement system, and its features are: Three-dimensional morphological data regarding cervical os patency were obtained under sterile conditions. 5 a system that collects data and operates according to the principle of non-invasive or minimally invasive measurement. sensor unit (2), processing the raw morphological data collected by the mentioned sensor unit (2), noise removal and digitization and data with the mentioned sensor unit (2) a data collection and processing module that enables communication (3), 10 processed by the mentioned data collection and processing module (3) By analyzing digitized three-dimensional morphological data, standardized and a trained artificial neural network that converts quantitative cervical dilation values. an artificial intelligence processing unit with network architecture (4), Quantitative cervical 15 produced by the mentioned artificial intelligence processing unit (4) dilation values, changes in these values over time, and visualizing clinical decision support data regarding the progression of labor a display and user interaction unit (5) that presents to the user the mentioned sensor unit (2), data collection and processing module (3), artificial energy of the intelligence processing unit (4) and the display and user interaction unit (5) 20 a power supply that meets your needs (6) It includes.
2. During labor, the cervical os (1.1) in the cervix of a patient (1) a cervical 25 for measuring the opening and evaluating cervical dilation It is a dilation measurement method, and its characteristic feature is; Determining the cervix (1.1) region where the measurement procedure will be applied and the sensor positioning of the unit (2) toward the cervical os opening, through the mentioned sensor unit (2), three-dimensional information regarding cervical os opening. Morphological data were collected under sterile conditions, using non-invasive or minimally invasive techniques. 30 collection according to the measurement principle raw morphological data collected by the mentioned sensor unit (2) to be sent to the collection and processing module (3), 17 raw morphological data is collected and processed by the mentioned data collection and processing module (3). data processing, noise removal and digitization, An artificial intelligence process processes and digitizes three-dimensional morphological data. transfer to unit (4), trained artificial neural network located in the mentioned artificial intelligence processing unit (4) 5 Analysis of three-dimensional morphological data and cervical using architecture standardized quantitative dilation values expressing os opening production, The quantitative dilation values produced are not comparable to the quantitative values obtained in previous measurements. Cervical dilation over time was compared with dilation values 10 determining the change, the quantitative dilation values mentioned, their change over time, and imaging and clinical decision support data regarding the progression of labor forwarding to the user interaction unit (5), Quantitative 15 through the mentioned display and user interaction unit (5) dilation values, changes in these values over time, and clinical Visualizing and presenting decision support data to the user. During the measurement, the sensor unit (2), the data collection and processing module (3), artificial intelligence processing unit (4) and display and user interaction unit (5) energy needs are met by the power supply (6) 20 It includes the steps of the process.
3. The method is compliant with Request-2 and its feature is that it is processed by an artificial intelligence processing unit (4). The quantitative dilation value produced indicates the cervical os opening in millimeters or Expressing it in centimeters means it includes the processing step. 25 4. The method is compliant with Request-2 and its feature is that it is processed by an artificial intelligence processing unit (4). The quantitative dilation value produced is higher than the quantitative value produced in previous measurements. Comparison of dilation values and the time of cervical dilation It is the determination of the rate of change within it. 30