WO2023113764A2

WO2023113764A2 - Touch glove

Info

Publication number: WO2023113764A2
Application number: PCT/TR2023/050224
Authority: WO
Inventors: Selda İldan ÇALIM; Pelin BAŞKURT
Original assignee: Midwifery And Womens Health Innovation Teknoloji̇ Li̇mi̇ted Şi̇rketi̇
Priority date: 2023-03-07
Filing date: 2023-03-07
Publication date: 2023-06-22
Also published as: WO2023113764A3

Abstract

The aim of the present invention pertains to the development of a vaginal touch glove (A) intended for assessing the degree of cervical dilatation (i.e., openness) during childbirth, specifically in healthcare settings where birth education, care, and services are rendered.

Description

DESCRIPTION

TOUCH GLOVE

Technical Field

The aim of the present invention pertains to the development of a vaginal touch glove intended for assessing the degree of cervical dilatation during childbirth, specifically in healthcare settings where birth education, care, and services are rendered.

Prior art

During the process of childbirth, a medical procedure known as a vaginal examination is conducted in order to assess the degree of cervical dilation and effacement. A vaginal examination is a medical procedure involving the manual assessment of the cervix. The procedure involves the introduction of the index and middle fingers of one hand into the vaginal canal in order to evaluate the condition of the cervix. In the present state of art, disposable gloves or sterile surgical examination gloves are used for vaginal examination at birth. Assessment of cervical dilation is a crucial component of monitoring labor progression during childbirth. During the process of assessing cervical dilation through a vaginal examination, healthcare professionals, such as doctors or midwives, utilize their gloved fingers to manually assess the cervix. By opening their fingers within the cervical canal, they are able to estimate the degree of dilation and convey this information to other members of the care team. For example, if there is enough space for only one finger to enter the cervical canal, it's evaluated as 1cm dilation, if there is enough space for two fingers to enter the cervical canal, it is evaluated as two or three cm. These measurement evaluations are subjective and may differ among individuals. Objective data cannot be obtained during the vaginal examination due to individual characteristics, such as the experience of healthcare professionals, distance perception, and finger thickness. This situation causes different results in the vaginal examinations results between healthcare professionals monitoring the labor. The inconsistency of vaginal examination results among healthcare professionals causes women to be more frequently examined vaginally, increasing the risks of infection, and decreasing the comfort and satisfaction of women in labor. Another existing challenge with the current technique is related to the training of students in acquiring the necessary skills for vaginal examinations. Currently, skills training on how to perform vaginal examinations during childbirth is primarily conducted using vaginal touch models and hospital-based practices. The students are taught to identify the opening and effacement of the cervix on the model by estimating the distance between their fingers. Subsequently, they are required to insert their fingers into the vagina touch model to learn the skill of locating the cervix and estimating the opening. However, this knowledge and experience are typically obtained through real-life patient examinations. It is neither ethical nor appropriate for students to learn this examination by experimenting on real patients many times in the hospital, and its almost impossible for them to reach findings containing objective data about the examination since the measurements are based on estimation. The fact that the signs are based on the individual estimation of the health personnel in the evaluation of the cervix during a vaginal examination causes subjective data to be obtained and unreliable results in the follow-up of labor. Unsafe signs obtained during the childbirth process related to vaginal examination create a worrying situation for the healthcare professionals monitoring the birth and the woman in labor.

None of the gloves used in the health field in the known applications of the technique are capable of measuring the distance between the fingers. Nowadays; while evaluating the cervical opening with the vaginal examination, the distance between fingers is expressed by an estimated measurement. The healthcare professional performs a vaginal examination while wearing disposable latex gloves, he places the index and middle fingers on the cervix and expresses the distance between the fingers as an approximation. If there is not enough cervical opening to open the fingers, an estimation is made based on finger thickness. This estimated subjective expression is derived from the experience of students and healthcare professionals. There isn't a material or an apparatus that measures the cervical opening by vaginal examination. When evaluating the cervical opening with the vaginal examination, the estimated measurement is expressed in centimeters or in fingers (ex: there is a finger opening; there is an opening of 3-4 cm; if the cervix is fully retracted and cannot be felt, the opening is referred to as complete). Scientific studies in this field; states that there are individual measurement differences in the evaluation of cervical dilatation by vaginal touch, and objective data cannot be obtained in the cervical examination.

With the advance in technology, transperineal ultrasonography can be used to measure the cervical opening. Since transperineal ultrasonography is costly and its use is under the authority of the physician, its usage in birth monitoring is not common. The monitoring and management of normal birth are under the midwives responsibility, and in most countries, midwives are not authorized to use ultrasonography. Therefore, the usage of transperineal ultrasonography devices to monitor labor anytime, anywhere, and by all healthcare professionals is neither appropriate nor possible.

As a result, the inadequacy of the current solutions has made it necessary to develop a new technique in the related technical field to solve the aforementioned problem.

The Aim of the Invention

The gloves utilized for vaginal touching during childbirth serve the primary purpose of maintaining hygiene standards and do not possess any exceptional attributes. The aim of this invention is to imbue gloves utilized during vaginal examination with the ability to measure the cervical canal and furnish precise data. This approach aims to obtain objective and precise data regarding the cervical opening, rather than relying on subjective estimations of the distance between fingers (such as 1cm, 2cm, ...10cm) during a vaginal examination. The absence of another device, such as gloves, able to measure the opening of the cervix by vaginal examination, makes the vaginal touch gloves, which is the subject of this invention, the first and unique element. Since clear results will be obtained with the vaginal touching glove, which is the subject of the invention, inconsistency between the examination findings of health workers is prevented. Healthcare professionals monitoring the labor with vaginal touching gloves will be able to safely monitor the labor with objective data. Determining the cervix examination with clear measurements will also prevent unnecessary vaginal examination of the pregnant woman. Women who have unnecessary and frequent vaginal examinations feel both physical and psychological discomfort at birth. Another aim of this invention is to avoid frequent vaginal examinations, protect women's health and privacy during labor, and increase the satisfaction of normal birth. Two distinct variants of vaginal touching gloves will be made available, with one version incorporating a sensor and the other version incorporating both a sensor and Bluetooth technology. The vaginal touch glove equipped with both sensor and Bluetooth capabilities is capable of capturing measurements, which can then be seamlessly transmitted to other devices, such as phones or tablets, through remote access. This data can be further analyzed with the aid of computer program software. The sensor-enabled vaginal touch glove allows the measurements to be transferred to the computer environment with software, to record the examination findings and to create evidence at birth. Thus, it allows the healthcare professionals responsible for childbirth to access the data quickly. These recorded measurements furnish health professionals with vital information and evidence pertaining to the timely diagnosis of abnormalities and effective management of labor. Moreover, they serve as essential evidence in conditions such as prolonged labor, enabling healthcare professionals to make informed decisions.

When students in childbirth education or healthcare workers examine the cervix on the model with the vaginal touch glove, which is the subject of this invention, their perception, and coordination about the distance between their fingers develop because they obtain concrete data. The instantaneous visual and objective data provided by the vaginal touch glove significantly enhance the active learning and decision-making processes of students and healthcare workers in a positive manner. Through the use of advanced technologies that provide objective data, students can refine their vaginal touching skills, resulting in more accurate and safer examinations in hospital settings. Midwifery and other health sciences students can use the vaginal touching glove, which is the subject of the invention, in hospital applications in order to prevent frequent examination of women during childbirth and to obtain objective concrete data. In the skill training of midwives who have just started in the delivery room, vaginal touching gloves can be used to improve their coordination and perception of the distance between the fingers. In addition, healthcare professionals such as paramedics and emergency medical technicians who have to manage delivery in emergency situations can also use vaginal touching gloves, which are the subject of the invention, to obtain concrete data on vaginal examination. Detailed Description of the Invention

Figures of the vaginal touching gloves that are suitable for the intended purposes of the invention are as follows;

Figure 1 - The general appearance of the sensor-enabled touch glove which is the subject of the invention.

Figure 2 - The block diagram of the vaginal touch glove with sensor feature subject to the invention.

Figure 3 - Block diagram of the subject of the invention with the sensor and Bluetooth-enabled vaginal touch glove.

The elements depicted in the aforementioned figures have been assigned numerical identifiers, which will be utilized throughout the remainder of the description:

A. Vaginal Touch Glove

1. Magnetic sensor

2. Magnet

3. Instrumentation Amplifier

4. Microcontroller

5. Power Supply Management Module

6. Battery

7. Screen

8. USB

9. Bluetooth Module

10. Measuring System

The subject matter of this invention concerns the vaginal touch glove (A), which comes in two variants: one equipped with sensors and another variant that is sensor-enabled and Bluetooth-compatible. In order to manufacture the vaginal touch glove (A), a range of fabrics such as jersey, combed cotton, nitrile, vinyl, latex, and bags can be utilized, in addition to materials like 3D printing and nanotechnology. The vaginal touch glove (A) may incorporate elements that are positioned on/within the glove and its duct system. The magnetic sensor (1), magnet (2), measuring system (10), and screen (7) can be mounted on the vaginal touch glove (A). The measuring system (10) is a circuit that is preferably located on the wrist of the glove and comprises the instrumentation amplifier (3), microcontroller (4), power supply management module (5), and battery (6). The screen (7) is situated on the measuring system (10). The magnet (2) can be located on either the index or middle finger of the vaginal touch glove (A), and serves as a magnetic field source for measuring the distance of cervical dilation from the reference point. When the magnet (2) is situated on either the index or middle finger, the magnetic sensor (1) is placed on the remaining free finger. The magnetic field generated by the magnet (2) can be detected by the magnetic sensor (1). A non-linear voltage is generated based on the intensity of the magnetic field detected by the magnetic sensor (1). (Figure-1)

It is necessary for the healthcare professional overseeing the labor to wear disposable gloves or sterile surgical examination gloves over the sensor-enabled vaginal touch glove (A). The vaginal touch glove (A) features a magnet (2) positioned on the outer surface of the middle finger, facing the ring finger, and a magnetic sensor (1) situated on the upper outer surface of the index finger, facing the thumb. The fingers containing the magnet (2) and magnetic sensor (1) can be interchangeable. In other words, the magnetic sensor (1) can be positioned on the middle finger facing the ring finger, and the magnet (2) on the index finger facing the thumb. As the primary objective is to ascertain the distance between the index finger and the middle finger, a magnetic sensor (1) placed in one of the fingers and a magnet (2) installed in the other finger would suffice for this purpose. To ensure clarity in the explanation, an illustrative instance will be provided, where the magnetic sensor (1) is positioned on the index finger while the magnet (2) is positioned on the middle finger of the vaginal touch glove (A).

When a healthcare professional opens their fingers in the cervical canal of the pregnant woman, tension occurs between the magnet (2) in the middle finger and the magnetic sensor (1) in the index finger. An analog output voltage is generated depending on the distance between the magnetic sensor (1) and the magnet (2). The resulting sensor output voltage is amplified through the instrumentation amplifier (3). The aforementioned system utilizes an instrumentation amplifier (3) to carry out the crucial signal-matching process between the voltage output of the sensor and the microcontroller (4). The microcontroller (4) initially linearizes the analog input voltage and subsequently converts the voltage parameter into distance. This entire process is facilitated by the microcontroller (4), which then transfers the resulting data to the screen (7) for display purposes. Thus, screen (7) serves as the primary platform for visualizing the distance measurement results obtained through the integrated workings of the microcontroller (4) and the aforementioned components. In this system, a lithium-based battery (6) is preferably used as an energy source. The battery (6) is used as an energy source in the measurement system (10). The battery (6) voltage is increased to 5V by the power supply management system (5). At the same time, the power supply management system (5) ensures that the battery (6) can be charged via USB (8). (Figure - 2)

The distinguishing feature of the present invention, which is the vaginal touch glove (A) with sensor and Bluetooth, lies in the inclusion of a Bluetooth module (9) that is absent in the previous version of the vaginal touch glove (A) with a sensor. This Bluetooth module (9) is integrated with the microcontroller (4), which in turn facilitates the conversion of the analog input voltage to the linearized voltage parameter, and ultimately to distance measurement. The resulting data is then transmitted to the screen (7) for display purposes, and subsequently, through the aid of the Bluetooth module (9), can be remotely accessed and recorded on devices with Android and/or IOS systems. This integration of features is depicted in Figure- 3.

Claims

1. A vaginal touch glove (A) used in the measurement of the dilation of the cervix of the pregnant woman during childbirth, comprising; a. a magnet (2) positioned on the index or middle finger which creates a magnetic field source at the reference point for the measurement of the distance of the dilatation of the cervix, b. In the event of the said magnet (2) is positioned on either the index or middle finger of the said vaginal touching glove (A), a magnetic sensor (1) is placed on the remaining free finger and produces linear tension according to the said magnetic field strength by detecting the magnetic field created by the said magnet (2), c. Microcontroller (4) linearizing non-linear analog input voltage, d. An instrumentation amplifier (3) that amplifies the output voltage generated by the said magnetic sensor (1) and performs the signal matching process between the said output voltage and the said microcontroller (4), e. A battery (6) used as the energy source of the said vaginal touch glove (A), f. A power supply management module (5) which increases the voltage of the said battery (6), g. a measuring system (10), positioned on the wrist part of the said vaginal touching glove (A), which is a circuit that houses the said instrumentation amplifier (3), the said microcontroller (4), the said power supply management module (5) and the said battery (6), and h. a screen (7) positioned on the said measurement system (10), which enables the display of the measurement results obtained after the voltage parameter is converted to distance with the help of the said microcontroller (4).

2. A vaginal touch glove (A) suitable to Claim 1, characterized in that; contains USB (8) that enables the battery (6) to be charged.

3. A vaginal touch glove (A) suitable to Claim 1, characterized in that; includes a Bluetooth module(9) that transfers data to the screen(7) and enables remote access to data and recording of data by transferring data to devices with Android and/or IOS system.