A device that calculates the time of birth

Abstract

The present invention relates to a device that autonomously obtains the data received from the Bishop scoring and many diversifiable measurements and visual data in addition to these data through a device with a sensor and camera system and calculates the time of birth with an artificial intelligence-based machine learning system through evaluations of the progress and time of birth, characterized in that it consists of a device body (C), a soft and flexible vaginal probe (1) positioned at the end of the device body (C), at least one sensor (2) measuring the changes in the cervix integrated into the probe (1), at least one camera (3) that obtains image data to detect and evaluate the changes in the cervix via the probe (1), a sensor (2) and a processor (5) that allows the analysis of the data obtained from the camera (3) with artificial intelligence algorithms, an information display (4) that allows the data results to be displayed, and a database (6) in which all data are continuously recorded.

Description

[0001] A DEVICE THAT CALCULATES THE TIME OF BIRTH

[0002] Technical Field

[0003] The present invention relates to a device that calculates the time of birth by autonomously obtaining the data obtained in the Bishop scoring and many diversifiable measurements and visual data in addition to these data through a device with a sensor and camera system and calculates the birth time of the evaluations of the progress and time of birth with an artificial intelligence-based machine learning system.

[0004] State of the Art

[0005] Childbirth is a process consisting of four stages. The first stage is characterized by painful uterine (womb) contractions and cervical dilatation that progresses to complete dilatation (opening) of the cervix. The second stage covers the period from the complete dilatation of the cervix to the birth of the baby. The third stage is the process from the birth of the baby to the removal of the placenta and membranes. The fourth stage includes the first four hours after the placenta is removed.

[0006] The first stage of birth is the longest. It consists of latent (0-6 cm), active (6-8 cm) and transition phase (8-10 cm). It takes an average of 12-16 hours in nulliparous pregnant women (who have not given birth before) and 6-8 hours in multiparous women (who have given birth before). The lower limit of cervical dilatation rate is 1.2 cm / hour in nulliparous and 1.5 cm / hour in multiparas. In the first stage of birth, the progression of birth is measured by Bishop scoring. In this way, appropriate interventions can be made, and measures can be taken when necessary.

[0007] The Bishop score is a medical assessment measure used to evaluate the maturation or opening of the cervix and is an instrument used in pregnancy management and birth planning to predict whether the birth is approaching. This score is used to determine how close vaginal birth is and estimate how long it takes for birth to begin. The Bishop score is determined by a healthcare professional during the physical examination and is based on the evaluation of the various components of cervical opening (dilatation), cervical length, cervical consistency, cervical forward inclination (anteflexion), and cervical position. Bishop score is determined by this examination, in which each parameter is evaluated numerically.

[0008] Since the cervix opens during vaginal birth and allows the baby to pass through the birth canal, the Bishop score measures how open the cervix is. When the cervix begins to mature correctly, the length of the cervix is also important for the detection of maturation because its length is shortened and is included in the Bishop score. Since the consistency, softness or hardness of the cervix is also important in terms of determining the birth process, it is one of the evaluation parameters. For example, the softening of the cervix may lead to the conclusion that the birth process is approaching. Parameters such as the position of the cervix and the forward inclination are among the parameters that are important in the control of the birth process in terms of providing information about the position of the uterus and the baby. The Bishop score is obtained by summing the scores given as a result of the evaluation of the parameters, and a higher Bishop score results in the cervix being mature and closer to the onset of birth. However, the Bishop score is not a tool used to determine exactly when the birth will start, but it only helps to make an estimate.

[0009] A Bishop score of <5 indicates immature cervix, while a score of >5 indicates mature cervix. The success rate is high if the necessary practices are performed for birth when the mature cervix is formed. If there is no progression in birth despite the Bishop score above 5 and the necessary intervention, operative delivery can be considered. This scoring is measured by a bimanual examination (vaginal examination).

[0010] Table 1. Bimanual examination is an extremely necessary application to monitor the progression of birth and to detect and intervene in high-risk situations in the early period. However, the first stage of birth is a long phase, and women who are waiting for birth at this stage need to be examined bimanually many times by different people in a row. However, especially in this stage, which lasts the longest, performing this examination at frequent intervals and not showing the necessary care during this application causes pain, discomfort, anxiety, and feelings such as fear, shame, guilt, weakness, stress, and decreased satisfaction of women related to birth. For example, stress causes the release of catecholamines via the HPA axis. In this case, the release of pain hormone (oxytocin) required for birth may be inhibited, and as a result, the incidence of prolonged birth and / or operative birth may increase.

[0011] In a study, women stated that "they were embarrassed (57.9%) during vaginal examination and that the reasons for embarrassment were due to showing their private parts (58.7%), that they experienced discomfort during the examination (88.4%) and that the feeling of discomfort they experienced was due to the fact that it was a "stressful" application (40.5%), and that they would feel safe (46.3%) if they were treated more gently and slowly during the vaginal examination." Frequent vaginal examination also causes vaginal dryness and susceptibility to infection.

[0012] Bimanual examination is a medical examination method that requires a healthcare professional to use both hands to evaluate the patient's body or organs. This examination method is frequently used during the pelvic examination, where the female reproductive organs are usually evaluated. During this examination, one hand is inserted into the vagina or rectum, while the other hand is used to assess the abdominal area from the outside. This type of examination, which helps the doctor or healthcare professional to better understand the patient's condition and to detect problems occurring in internal organs, tissue anomalies or pathological changes, plays an important role in diagnosing the patient's condition in the monitoring process and making appropriate interventions in a timely manner. However, this type of examination should always be performed very delicately compared to others and with a high degree of care for the comfort of the patient.

[0013] In the bimanual examination or in other words, in the vaginal examination method, the external genital area is evaluated first. If there is a visible lesion, the location of this lesion is determined. This method, which makes it possible to evaluate our genital organs in the abdomen and even to detect large masses in the uterus or ovaries, has an important place among the gynecological examination stages. Although it is a very useful tool in the diagnosis and evaluation of many medical conditions such as detecting and treating hidden vaginal infections in the early period and taking the necessary precautions at the right time by making early diagnosis and evaluation without worsening the process, it also has some disadvantages. For example, bimanual examination can often be an uncomfortable or embarrassing experience for patients. In particular, vaginal or rectal examinations may cause pain or discomfort in patients, as they involve the manual evaluation of sensitive tissues. Apart from this, when performed with non-sterile hands, it becomes a very open type of examination for infection. In addition, with this examination, knowledge and experience are needed to create an accurate diagnosis and treatment plan by correctly evaluating factors such as the consistency, position and patency of the tissues. Training, experience, and time are needed to apply bimanual examination skills correctly. Therefore, healthcare professionals who do not receive appropriate training or do not have sufficient experience may have difficulties in making an accurate assessment. In particular, it can be misinterpreted by new healthcare personnel with lack of experience, and since this incorrect evaluation will lead to a wrong diagnosis and an incomplete treatment plan, it causes misinformation about the progression of birth. Meanwhile, the fact that the finger sizes of the people are different may lead to incorrect, incomplete or individualized evaluation results.

[0014] As a result, a new technology is needed that can overcome the above-mentioned disadvantages.

[0015] Definition of the Invention

[0016] This invention is a device that calculates the time of birth, characterized in that it is a new technology that allows the Bishop score to be calculated with high accuracy and high precision and the evaluations of the progress and time of birth to be made entirely with an artificial intelligence-based machine learning system.

[0017] In order to realize all the objects that will emerge from the abovementioned and detailed description below, the invention aims to determine the progression and time of birth as a result of the processing of these data with a machine learning system by obtaining the data obtained in the Bishop scoring autonomously through a device with a sensor and a camera system without the need for a bimanual examination in women in birth.

[0018] The invention allows to automatically obtain the data obtained in the Bishop scoring, which helps to estimate how close the birth is by evaluating the maturation status of the cervix, through a device with a sensor and camera system. In this way, high-precision, real-time, high accuracy result data are obtained in more sterile and safe ways. This helps to better plan the delivery process for both patients and healthcare professionals and is important to better control the timing of birth and intervene when necessary.

[0019] The invention enables the evaluation of the condition of the cervix with a fully automated system by reducing the need for bimanual examination, to guide healthcare professionals on how to direct birth, to help patients and healthcare professionals make the right decisions, to monitor the birth process and to prevent unnecessary interventions.

[0020] This invention allows the Bishop score to be calculated with high accuracy and high precision with a bimanual examination and the evaluations of the progress and time of birth to be made entirely with an artificial intelligence-based machine learning system.

[0021] The system of the invention helps to prevent possible complications, to make preliminary interventions on time and to reduce C-section rates.

[0022] The present invention eliminates the necessity of performing the Bishop scoring, which is a medical measurement generally used in the late stages of pregnancy or during the bimanual examination to monitor the onset of birth and to evaluate the maturation, opening status, consistency, length, and position of the cervix. Obtaining all the data with a high accuracy rate with an automatic system helps to estimate how close the birth is.

[0023] The present invention enables the contractions that will lead to the opening of the cervix and the onset of birth, and the severity and frequency of these contractions, to be collected automatically from the patient, indicating that the birth is about to begin, including the leakage of the amniotic fluid. The present invention shows that it is possible to perform this scoring without bimanual examination, which normally requires direct palpation to assess factors such as the opening, consistency, length and position of the cervix and the position of the baby's head.

[0024] This invention eliminates the necessity of calculating the Bishop score, which helps to estimate how close the birth is by evaluating the maturation status of the cervix, under the supervision and during the examination of a healthcare professional with high knowledge and experience due to the commitment to bimanual examination. Since this provides important information about how to direct and monitor birth, it can help healthcare professionals to better plan the birth process, regardless of whether they are experienced or inexperienced.

[0025] The invention is a hygienic, sterile and safe device with a portable design, working with batteries or any rechargeable power supply, offering painless measurement and evaluation, providing ease of use. Since the device has small dimensions, it is easily used both at home and in the hospital environment, and this design of the device allows it to be easily placed in the vagina, providing minimal discomfort.

[0026] The invention saves time and effort for healthcare professionals, provides a less painful measurement experience by reducing patients' hospital visits, and reduces the crowd in hospitals by providing special space and comfort for patients.

[0027] In this invention, automatic calculation of the Bishop score, which allows to determine the ideal time of birth, is important to better control the timing of birth and intervene when necessary. Since the progress of the pregnancy and the progress of the birth depending on the body structure of the woman vary and when it will start, it is aimed to increase the accuracy rate of these predictions made by bimanual examination, which is insufficient to evaluate this process, with the system of the invention.

[0028] This invention allows for more accurate estimates of the progress of birth and when birth will begin, as it allows more professional collection of signs and signals that birth is approaching and this data is analyzed with this system based on machine learning or artificial intelligence systems. After the data collected in the system subject to the invention is transferred to the artificial intelligence-based system for processing, the time of birth is automatically calculated by the system as a result of the processing of the data collected here and presented to the healthcare professionals or the patient.

[0029] The structural and characteristic properties and all the advantages of the product subject to the invention will be understood more clearly with the figures given below and the detailed description with reference to these figures, and therefore the evaluation should be made by taking these figures and detailed description into consideration.

[0030] Description of the Figures

[0031] The invention will be described with reference to the accompanying drawings so that the features of the invention will be more clearly understood and appreciated, but it is not intended to limit the invention to these particular embodiments. On the contrary, it is intended to encompass all alternatives, modifications and equivalents which may be included in the scope of the invention as defined by the appended claims. It should be understood that the details shown have been provided to ensure the demonstration of preferred embodiments of the present invention and shaping of the methods and to provide the most useful and understandable definition of the rules and conceptual features of the invention. The figures are as follows:

[0032] Figure 1 A front view of the device of the invention.

[0033] Figure 2 A perspective view of the inventive device.

[0034] Figure 3 A perspective view of the device of the invention.

[0035] Figure 4 A view of a block diagram of the working principle of the device of the invention

[0036] The figures that will assist the understanding of this invention are numbered as specified in the enclosed image and given below along with their names.

[0037] Description of the References:

[0038] 1. Probe

[0039] 2. Sensor

[0040] 3. Camera 4. Information Display

[0041] 5. Processor

[0042] 6. Database

[0043] C. Device Body

[0044] Description of the Invention

[0045] The invention consists of a device body (C), a soft and flexible vaginal probe (1) positioned at the end of the device body (C), at least one sensor (2) measuring the changes in the cervix integrated into the probe (1), at least one camera (3) that obtains image data to detect and evaluate the changes in the cervix integrated into the probe (1), a sensor (2) and a processor (5) that allows the data obtained from the camera (3) to be analyzed with artificial intelligence algorithms, an information display (4) that allows the data results to be displayed and a database (6) where all data are constantly recorded.

[0046] The invention has at least one sensor (2) configured to measure the uterine contractions and the severity and frequency of these contractions, to detect cervical changes such as opening of the cervix (cervical dilatation), length, position, forward inclination (anteflexion), consistency, thinning and softening degree, and the position of the baby's head, to detect the amnion's open or closed state and the leaked amniotic fluid as a result of the rupture of the amniotic membrane. The invention has an information display (4) positioned on the surface of the device body (C).

[0047] There is a probe (1) in the product of the invention, which specially includes the features of transvaginal ultrasonography (TVUS) and special endoscopic devices such as hysteroscopy. The sensors (2) in the product subject to the invention can be of many types and features. It can be an electrical sensor (2) that detects changes by measuring its conductivity properties.

[0048] The invention comprises an acoustic or touch or thermal or laser doppler vibrometer sensor (2) that measures the opening of the cervix and / or the hardness and / or elasticity and / or consistency of the tissue using the reflection of the sound waves from the tissue. It also includes a pressure or force sensor (2) that obtains the opening and / or position and / or inclination and / or hardness and / or softness degree and / or consistency data of the cervix by measuring the changes applied to the tissue. The invention has a conductivity sensor (2) that measures the electrical conductivity of the amniotic fluid and conveys information about the components, compositions and density of the fluid. There is a color sensor (2) to detect whether the amniotic fluid is clear or the presence of meconium (baby feces) by analyzing its color in the product subject to the invention.

[0049] The invention comprises an enzyme sensor (2) for detecting specific enzyme activities in the amniotic fluid. It also includes a pH sensor (2) to measure the vaginal pH level.

[0050] Detailed Description of the Invention

[0051] In the invention, there is at least one sensor (2) measuring by positioning in the vagina and a soft and flexible vaginal probe (1) in which at least one camera (3) is integrated at the end of the device body (C). There is an information display (4) with LED light on the handle part controlled by the operator to ensure that this probe (1) is manipulated correctly to the patient. This information display (4) is configured to allow the measurement results to be displayed by the operator. The integration of LED lights to this information display (4) allows the probe (1) to continue its function in dark environments.

[0052] At least one sensor (2) in the invention is configured to measure the uterine contractions and the severity and frequency of these contractions; to detect cervical changes such as opening of the cervix (cervical dilatation), length, position, forward inclination (anteflexion), consistency, thinning and softening degree and the position of the baby's head; to detect the amnion's open or closed state and the leaked amniotic fluid as a result of the rupture of the amniotic membrane. Image data are obtained to detect and evaluate the changes in the cervix with at least one camera (3) placed at the end of the vaginal probe (1).

[0053] In the invention, a high-resolution image is obtained by including the transvaginal ultrasonography (TVUS) features of the ultrasonography device in the vaginal probe (1) positioned in the vagina. With the vaginal probe (1), which integrates these features that make up the uterine, cervical and intrauterine images for evaluation using high-frequency sound waves, measurement data on the cervical opening and / or the inclination / forward inclination (anteflexion) and / or position of the cervix and / or the cervical length and structure and / or data on the amniotic fluid levels and amount and / or image data to help display the position of the baby and the lower, upper or lateral position of the head to evaluate the position of the head in the birth canal are obtained.

[0054] In the invention, image data are obtained with the camera (3) by including the features of the endoscopy device in the vaginal probe (1) positioned in the vagina, more specifically, the features of special endoscopic devices such as hysteroscopy. With the vaginal probe (1), which integrates these features, measurement data on the cervical opening and / or the inclination and / or position of the cervix and / or the cervical length and structure are obtained.

[0055] At least one sensor (2) of the invention can be an electrical sensor (2) that detects changes by measuring the electrical conductivity properties of tissues. With the vaginal probe (1), which integrates these features of the sensor (2), for example, the cervical opening can be measured.

[0056] At least one sensor (2) of the invention can be a thermal sensor (2) that detects changes in body or tissue temperature and provides data on the cervical opening and / or the hardness and / or elasticity of the tissue.

[0057] At least one sensor (2) of the invention can be an acoustic sensor (2) that measures the opening of the cervix and / or the hardness and / or elasticity and / or consistency of the tissue using the reflection of the sound waves from the tissue.

[0058] At least one sensor (2) of the invention can be a touch sensor (2) configured to measure the hardness and / or softness of the cervical tissue and / or the resistance and / or elasticity and / or consistency of the surface.

[0059] At least one sensor (2) of the invention can be configured as a laser doppler vibrometer that measures the vibration properties of the surfaces and obtains data on the hardness and / or elasticity and / or consistency of the tissue.

[0060] At least one sensor (2) of the invention can be a pressure sensor (2) that obtains data on the position and / or inclination of the cervix and / or the degree and / or consistency of the hardness and / or softness by measuring the pressure and pressure changes applied to the tissue. For example, the pressure sensor (2) may be configured to measure the pressure changes that occur during the expansion of the cervical opening.

[0061] At least one sensor (2) of the invention can be a force sensor (2) that detects the changes created by the force applied by contacting the tissue and produces data on the hardness and / or softness and / or consistency and / or elasticity of the tissue.

[0062] At least one sensor (2) of the invention can be a conductivity sensor (2) that will provide information about the components, compositions and density of the fluid by measuring the electrical conductivity of the amniotic fluid, a color sensor (2) to detect whether the amniotic fluid is clear by measuring its color or the presence of meconium (baby feces), and an enzyme sensor (2) to detect specific enzyme activities in the amniotic fluid.

[0063] At least one sensor (2) of the invention can be configured as a pH sensor (2) to measure the vaginal pH level.

[0064] At least one sensor (2) of the invention can be any sensor that detects cervical mucus and measures the consistency and / or color of this discharge.

[0065] In the invention, at least one sensor (2) integrated into the vaginal probe (1) and at least one camera (3) obtained by uterine contractions, the severity and frequency of these contractions, opening-opening of the cervix (cervical dilatation), cervical length, cervical position, cervical inclination-forward inclination (anteflexion), cervical consistency, cervical thinning and softening degree, cervical hardness, cervical elasticity, baby's position and head position data are analyzed with artificial intelligence algorithms on the processor (5) and many diversifiable results data are obtained such as the progress of the patient's pregnancy process, predictions about whether the birth is approaching or not.

[0066] In the invention, the data collected on the amount, components, color, electrical conductivity, enzyme amount, vaginal pH level, consistency and color of the amniotic fluid leaked as a result of the rupture of the amniotic membrane, which is obtained by at least one sensor (2) integrated into the vaginal probe (1) and at least one camera (3), are analyzed with artificial intelligence algorithms in the processor (5) and many diversifiable result data are obtained, including the progress of the patient's pregnancy process, whether the birth is approaching and estimates of the time of birth.

[0067] In the invention, at least one sensor (2) integrated into the vaginal probe (1) positioned in the vagina and configured in various variations as described above and all measurement and image data obtained through the camera (3) are recorded in the database (6) to monitor and evaluate the birth process. All data obtained from the vaginal probe (1) positioned inside the patient are transferred to the processor (5) and converted into a meaningful data set with artificial intelligence algorithms. These data are collected in various stages and analyzed in the processor (5) with the support of the constantly updated database (6) about the progression of birth and high accuracy result data are obtained. After the data obtained by the sensor (2) and camera (3) integrated into the vaginal probe (1) are processed and analyzed in the processor (5) with artificial intelligence algorithms, the resulting data are displayed on a LED light information display (4) on the handle part controlled by the operator to ensure that the probe (1) is accurately manipulated to the patient. These data observed on the information display (4) are continuously monitored and interpreted by healthcare professionals to determine the stage of birth and plan appropriate medical interventions. Data on the uterine status are continuously collected from the place where the vaginal probe (1) is placed, and analysis result data are obtained with artificial intelligence algorithms in the processor (5) continuously. The resulting data can be transferred by visualizing with numerical data and / or a graph. These data are stored in the database (6) and are constantly updated to make comparisons, monitor treatment or increase the accuracy of medical diagnoses. The resulting data is monitored remotely by transferring to any electronic equipment such as phones, computers, tablets, etc. with a wired or wireless communication network.

Claims

CLAIMS1. The invention relates to a device for calculating the time of birth, characterized in that it comprises the following:- a device body (C),- a soft and flexible vaginal probe (1) positioned at the end of the device body (C),- at least one sensor (2) integrated in the probe (1) that measures changes in the cervix,- at least one camera (3) integrated in the probe (1) that acquires image data to detect and evaluate changes in the cervix,- a processor (5) that allows the data obtained from the sensor (2) and camera (3) to be analyzed with artificial intelligence algorithms,- an information display (4) allowing the display of data results; and- a database (6) where all data are constantly recorded.

2. A device for calculating the time of birth according to claim 1, characterized in that it comprises at least one sensor (2) configured to measure the uterine contractions and the severity and frequency of these contractions, to detect cervical changes such as opening of the cervix (cervical dilatation), length, position, forward inclination (anteflexion), consistency, thinning and softening degree, and the position of the baby's head, to detect the open or closed state of the amnion and the leakage of amniotic fluid due to rupture of the amniotic membrane.

3. A device for calculating the time of birth according to claim 1, characterized in that it comprises an information display (4) positioned on the surface of the device body (C).

4. A device for calculating the time of birth according to claim 1, characterized in that it comprises a probe (1) which is specially equipped with features for transvaginal ultrasonography (TVUS) and features for special endoscopic devices such as hysteroscopy.

5. A device for calculating the time of birth according to claim 1, characterized in that it comprises an electrical sensor (2) that detects changes by measuring the electrical conductivity properties of the tissues.

6. A device for calculating the time of birth according to claim 1, characterized in that it comprises an acoustic or touch or thermal or laser doppler vibrometer sensor (2) that measures the opening of the cervix and / or the firmness and / or elasticity and / or consistency of the tissue using the reflection of sound waves from the tissue.

7. A device for calculating the time of birth according to claim 1, characterized in that it comprises a pressure or force sensor (2) which measures changes applied to the tissue and obtains data on the opening and / or position and / or inclination and / or hardness and / or softness and / or consistency of the cervix.

8. A device for calculating the time of birth according to claim 1, characterized in that it comprises a conductivity sensor (2) which measures the electrical conductivity of the amniotic fluid and provides information about the components, composition and density of the fluid.

9. A device for calculating the time of birth according to claim 1, characterized in that it comprises a color sensor (2) for measuring the color of the amniotic fluid to determine whether it is clear or the presence of meconium (baby feces).

10. A device for calculating the time of birth according to claim 1, characterized in that it comprises an enzyme sensor (2) for detecting specific enzyme activities in the amniotic fluid.

11. A device for calculating the time of birth according to claim 1, characterized in that it comprises a pH sensor (2) for measuring the vaginal pH level.

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