An oral-motor and sucking-swallowing assessment device

Abstract

The invention is a device (100) for an accurate and comprehensive oral-motor and sucking-swallowing assessment, wherein the device simultaneously assesses the negative intraoral pressure during sucking, the expression pressure which is the compression between the tongue and palatine during sucking, and the breathing coordination before, during and after a sucking / swallowing behavior, characterized in that it comprises two connector threads (115) for a head input and a charging input, to integrate the device (100) with the external sensor heads; an analysis interface (300) for displaying (340) the results via a display of a mobile device after the data transportation to a server and the data security protocols (230) are performed, subsequent to the control (220) of the connections; a lip-closing force measuring head (140) which is integrated into a head intermediate body (130) to measure the force applied by the lips for closing in units of pressure; and / or a sucking / swallowing positive expression pressure measuring head (160) which is integrated into a head intermediate body (130) to measure the compression force between the tongue and palate during sucking / swallowing; and / or a sucking / swallowing and breathing control measuring head (180)to track the exhalation behavior during and after sucking / swallowing, in which the measuring sensors are present.

Description

[0001] AN ORAL-MOTOR AND SUCKING-SWALLOWING ASSESSMENT DEVICE

[0002] Technical Field

[0003] The invention relates to a device for an accurate and comprehensive oral-motor and sucking-swallowing assessment, wherein the device simultaneously assesses the negative intraoral pressure during sucking, the expression pressure which is the compression between the tongue and palatine during sucking, and the breathing coordination before, during and after a sucking / swallowing behavior.

[0004] State of the Art

[0005] A newborn’s sucking ability requires the coordinated sucking-swallowing-breathing actions and is divided into two basic types: nutritive and non-nutritive. The non-nutritive sucking (NNS) is an infant’s ability to suck without any nutritional intake. In this context, NNS has a burst-pause pattern, with each burst containing 6-12 suck cycles and a within burst frequency of 2 Hz, and it has been stated that NNS can potentially predict later neurodevelopment in various domains (e.g., motor skills, balance, intelligence, and language) (Wolthuis-Stigter et al., 2015; 2017). In relation to that, Pineada and et al. (2019) found that the premature infants who had more variability and less stability in NNS patterns also had more medical complications. Indeed, these findings are in line with the other studies showing variable NNS patterns in infants with comorbidities such as respiratory distress syndrome (Poore et al., 2008) and preterm birth (da Costa et al., 2010). Additionally, infants born to mothers with gestational diabetes have been identified as another population with poor oral feeding. In relation to that, researchers observed that infants born to mothers treated with insulin had fewer suck bursts as well as a reduced number of sucks per suck burst, which is consistent with an immature sucking pattern. Researchers think that this is caused by neuro-immaturity in infants born to diabetic mothers (Bromiker et al., 2006).

[0006] Zimmerman et al., (2021), who examined the effect of prenatal environment exposures on the sucking pattern, examined the relationship between prenatal maternal stress and NNS in newborns and observed that a higher prenatal maternal stress differentiated the NNS pattern in the infant. Researchers suggest that this difference in NNS pattern may serve as an early indicator of later neurobiological problems. In parallel, Zimmerman et al. (2021) observed that intraoral negative pressure waves in the neonatal NNS had a lower frequency and a higher amplitude compared to the control group together with prenatal phthalate exposure as an environmental exposure. As a matter of fact, there are studies associating the phthalate exposure during pregnancy with low scores in language development in boys (Olesen et al., 2018; Bornehag et al., 2018). In addition, it is stated that the increased oxidative stress levels during pregnancy (Ferguson et al., 2014; Ferguson et al., 2015) may affect fetal neurodevelopment. In this context, defining the NNS as a sensitive indicator of neurotoxicity is thought to provide a tool for early detection of exposure-induced changes in neurodevelopment (Zimmerman et al., 2021). In this context, information on the NNS pattern of a newborn changing in relation to the prenatal environment exposure may help to early predict possible developmental delays during the postnatal period and guide the related treatments during early infancy and childhood. However, objective neonatal neurofunction assessments are limited. Although the standardized tests such as the Bayley scales are useful for the developmental assessment of newborns, they may be influenced by many factors, such as practitioner experience and training, and the other individual variables. Therefore, there is a need to develop quantitative and later development-related early physiological measurements. In this context, the non-nutritive sucking (NNS) may be an early measure of neonatal brain function (Slattery et al., 2012).

[0007] The Agency for Healthcare Research and Quality classifies telehealth into 3 distinct categories: (1) real-time video telehealth between the patient and a health care professional; (2) store and forward health data, such as the sharing of medical images or data between providers; and (3) technologies which involve the use of telehealth to remotely monitor patients' health, also known as remote patient monitoring (Health Information Technology, 2023). The general purpose of remote monitoring and treatment services is to monitor and / or treat more than one individual at the same time outside of the traditional health institutions. In remote monitoring, the relevant health functions are measured, and the individuals are given feedback about their health status. The data measured is sent to a central server system which provides these data to the authorized end users both in real time (live data) and off-line (stored in a database). The authorized end users (healthcare providers and technical personnel) may access data anytime and anywhere; therefore, they may display patient data via any mobile device when needed, regardless of time and patient location. In this context, remote monitoring is a method that makes it easier for individuals to reach the clinician. Thus, the sucking abilities of newborns, especially those at high risk of infection, may be obtained at home and / or in another place other than a hospital and may be instantly transmitted to the clinician (Hermens and Vollenbroek-Hutten, 2008). In this context, certain remote monitoring systems used especially in the pediatric and / or neonatal population (Sasangohar et al., 2018) include continuous glucose monitoring, cardiovascular implantable devices, non-contact heart rate monitoring in the neonatal intensive care unit (Bal, 2015), and mobile robotic devices for remotely monitoring patients in the neonatal intensive care unit.

[0008] Considering that sucking ability is one of the discharge criteria for premature infants, it is important to monitor the sucking abilities of both premature and term newborns. The main motivation of the proposed product is to provide a user-friendly, reliable and non- invasive tool which may objectively measure the coordination between sucking, swallowing and breathing and provide remote monitoring for the family and / or clinician. In addition, this device which may allow remote monitoring due to its remote monitoring system and KVKK compliant data security protocols will enable the clinician and the client / patient to share the data instantly and the clinician to access old data from all mobile devices with Internet access. Thanks to the loT integration of the system, the recording waves of historical and / or current measurements may be observed at any time or in any environment, via any smart device (with an Internet connection) without the need for any external equipment. This may also be a part of the application process of the exercises recommended for the rehabilitation of dry swallowing or sucking abilities of children with swallowing and / or sucking disorders. Thus, it is both a measurement system for the sucking assessment and a system which may be used for a rehabilitation step due to the instant data flow between the family and the clinician, without the need for a hospital visit in case of a possible sucking insufficiency and / or disorder. In addition, due to instant data flow, sucking and feeding monitoring of the newborn after discharge may be carried out more regularly and systematically.

[0009] There are different systems developed in this context. Kron et al. (1963) were the first researchers to record negative intraoral pressure values during active sucking by means of a pressure transducer (KRON apparatus) and define certain parameters (sucks per minute, volume consumed per minute and average pressure change per minute) on the wave they obtained. Researchers concluded that term infants altered their rate of sucking to increase the amount of liquid consumed on the second and third days of life (Kron et al., 1963).

[0010] Medoff-Cooper et al., (2009) examined the correlation of the scores obtained from a 5- minute non-nutritive sucking assessment and the Bayley Developmental Scale with a modified version of the KRON apparatus. The findings of the researchers are consistent with the suggestion that the regulation of sucking behavior during the neonatal period may be an early risk indicator for the neurodevelopmental delays that occur in premature infants (Mizuno and lleda, 2001). Based on a manual review of sucking pressure records, Mizuno and lleda (2001) confirmed that the sucking performance at 40 weeks PMA was a significant and independent predictor of the developmental status assessed with the Bayley Scale 1 year later. In this context, researchers stated that a tool to be developed for neonatal sucking assessment could offer a cost-effective early screening strategy for preterm infants at greatest risk for the developmental delay (Mizuno and lleda, 2001). Ongoing modifications of the KRON apparatus have been published under the name nutritive sucking apparatus (M-CNSA) (Medoff-Cooper et al., 2015). The final form of the apparatus is marketed under the name NeoSUCK-NTraniner device.

[0011] In order to better understand the relationship between sucking, swallowing, and breathing, Mizuno and Ueda (2003) modified feeding bottle nipples routinely used to measure negative intraoral pressure. The researchers found that the sucking pressure, frequency and duration mature with age for the healthy preterm infants, similar to the results of Bromiker et al., (2005). They also reported that breathing and swallowing coordination matured with age (Mizuno and Ueda, 2003).

[0012] Fucile et al., (2009) observed the sucking and expression performances of the standard feeding bottles and a vacuum-free feeding bottle system. The sucking and expression components were monitored via two pressure transducers (Model SPR- 524, Millar Instruments, Houston, TX). For sucking, one of the transducers was inserted through a polyethylene tube flush with the tip of the nipple without entering the infant's mouth. The expression was monitored through a second transducer connected to a catheter consisting of a soft plastic tube, and the compressible plastic portion was brought out at the level of the nipple. The catheter was positioned upward against the hard palate to ensure an accurate recording of the expression component. According to the results of the research, the use of non-vacuum feeding bottles in infants born between 26 and 29 weeks’ gestational age has been observed to improve the oral feeding performance compared to the use of standard feeding bottles, that is, it was characterized by greater overall intake, rate of milk transfer and shorter feeding time.

[0013] Lang et al., (2011) designed a system that monitors intraoral pressures during nutritive sucking (Orometer). The sucking ability of all infants was observed with the same type of feeding bottle and nipple (Orometer), and recordings were continued for up to 15 minutes or as long as the infant continued to feed. However, analyzes were limited to the first 8 minutes of feeding. A sucking burst was defined as a sucking group separated from adjacent sucking groups by >3 s, and an interburst pause was defined as any period of time longer than 4 s, measured from the time of the peak of the last sucking in one burst and the time of the peak of the first sucking of the following burst. The parameters examined in this context are: number of suck bursts during the time interval analyzed, number of sucking peaks, number of sucks per minute, mean of sucking peaks, mean of the number of suck bursts to the number of sucking peaks, mean suck burst duration, mean pause time, mean amplitude variability (standard deviation of consecutive suction amplitudes within the burst), mean variability of burst durations (standard deviation of pause durations between bursts), and coefficient of variation of suction amplitudes (standard deviation divided by the mean).

[0014] To measure both sucking and expression, Tamilia et al. (2016) developed a portable sucking monitoring device (SuMOD) designed to be easily integrated into any normal feeding bottle and an analytical automatic system for data analysis.

[0015] Capilouto et al. (2014) produced a pacifier with piezoelectric crystals strategically located to enable direct measurement of nipple kinematics during non-nutritive and nutritive sucking, however the researchers stated that this system was not practical for the assessment process, and they improved the system and created a system called nfant ® Feeding Solution (nFS; NFANT Labs, Marietta GA, USA). This system has been approved by the FDA for use in the neonatal intensive care unit to assess the sucking performance of infants and has researches, the validity of which has been proven (Capilouto et al., 2019a; 2019b). Ebrahimi et al., (2019) developed a portable pacifier with a system to assess nonnutritive sucking in infants. A BMP180 digital barometric pressure sensor (Bosch Sensortec®) was used as a sensor in the research to measure the negative pressure of suction. The sensor has a built-in 16-bit ADC, which eliminates the need for an external ADC and consequently reduces the power consumption of the system. The sampling rate of the sensor was set to 16 samples / second in this study in order to accurately analyze NNS frequency components (below 4 Hz) and also, optimize the power consumption and system memory. An Atmega328-AU microcontroller (Atmel ®) was used as the processor unit to communicate with the pressure sensor through the I2C interface. The microcontroller extracts the value of negative NNS pressure and is used to transfer and store the same in a text file on the on-board micro-SD memory card. The parameters examined in the research are rate of sucking peaks per minute (sucking frequency), number of sucks per minute, number of suck bursts per minute and mean duration of bursts, number of pauses per minute and mean duration of pauses, and maximum peak amplitude during sucking (mbar) (Ebrahimi et al., 2019).

[0016] Akbarzadeh et al., (2020) used a system (SLIMOD) that can record both nutritional and non-nutritive sucking patterns. Thanks to the system they developed, the researchers were able to record expression pressure (the positive pressure created by the compression of the closed-end rubber catheter by the palate and tongue) and the intraoral (negative) pressure occurring during sucking. 2 different pressure sensors were used to record both patterns. MP3V5004GP sensors were used for Expression Pressure (EP) measurement and MP3V5050V sensors were used for Intraoral sucking pressure (IP) measurement. The sensor used for IP measurement was also used by Tamilia et al., (2015). A microcontroller called "ATmega8A" was used to digitize the values of the sensor. The Analog-Digital Convector (ADC) and microcontroller used transmit the signals wirelessly to a host system via Bluetooth, and the system may save the signals in the internal memory thereof for off-line processing. The researchers used a low-pass filter (< 5 Hz) to remove artifacts occurring in the recorded EP and IP signals during analysis. All data were recorded for 2 minutes, and analyzes were performed over this period. The parameters analyzed are sucking frequency per minute (sucking peaks are counted numerically and divided by two), mean sucking duration (calculated by summing all intervals during which sucking occurs), and mean of the EP and IP pressure amplitudes during sucking (the duration corresponding to EP and IP signals is found, and the mean of the absolute value is calculated). Researchers examined the relationship between infants' APGAR scores and sucking patterns and showed that those with lower Apgar scores had lower pressure amplitudes during sucking (Akbarzadeh et al., 2020).

[0017] Zimmerman et al., (2021) investigated whether exposure to phthalate metabolites during pregnancy had an effect on non-nutritive sucking parameters. The researchers recorded non-nutritive sucking by means of a pressure-sensor pacifier and stored the information in a data acquisition system (Power Lab, ADInstruments, Dunedin, New Zealand) and then analyzed the same on a system connected to a laptop computer via the LabChart software (ADInstruments). The recording period continued for 5 minutes, but the researchers selected and analyzed the most active 2 minutes. Researchers manually selected NNS bursts using the following criteria. The selection criteria are that “bursts should contain two or more suck cycles, the amplitude of each suck cycle should be above 1 emH 2 0, and a cycle is considered a new burst if there is an interval of >1,000 ms therebetween.” These criteria are similar to previous studies examining NNS in young infants (Barlow et al., 2012, Estep et al., 2008, Poore et al., 2008a, Poore et al., 2008b). According to the results of the research, the exposure to phthalate metabolites during pregnancy has been observed to be caused the infant's non- nutritive sucking frequency to be slower and the amplitude to be higher.

[0018] In parallel with the development of technology, the systems developed primarily for the identification of newborn sucking abilities have become a promising solution for the assessment of adult swallowing abilities, along with the use of sensitive pressure sensors for negative intraoral pressure measurement. In the relevant studies, assessments were made regarding the oral phase of swallowing by measuring the intraoral pressure generated during active or passive bolus intake of different consistencies. These systems, which arise from any structural disorder neurologically, or in oro-facial region and serve to assess especially the oral phase of swallowing, generally include GMSD2BR, GMSD350 and GMSD350MR (Greisinger electronics, Regenstauf, Germany) sensors, and the sensors are connected to a computeroperated manometer (GDLISB 1000 ®, Greisinger electronics, Regenstauf, Germany) (Adamske et al., 2021; Fuentes et al., 2015; Engelke et al., 2014; Engelke et al., 2011; Santander et al., 2013; Kndsel et al., 2016). Said studies discuss the results obtained with the systems designed for the nutritive and / or non-nutritive sucking assessment. In this context, an objective assessment of a newborn’s sucking behavior has been carried out and is continued to be carried out by researchers through different systems, conditions and participants. One of the systems developed for the objective assessment of a newborn’s sucking behavior is the invention subject to the patent application number US201213457154. The invention relates to methods for using a therapeutic system. Specifically, the present invention relates to procedures and methods for using a system with hardware, software and device components to assess and teach the non-nutritive sucking (NNS) pattern in a patient. The methods involve configuring hardware and software systems to receive data from the orofacial stimulator appliance and activate the same as a tactile stimulus.

[0019] Another study is the invention that is the subject of the patent application number WO2018US26384. The subject of the invention enables direct measurement of the movement of the tip of the nipple attached to the feeding bottle during non-nutritive and nutritive sucking and, as mentioned above, is sold under the trade name nfant ® Feeding Solution (nFS; NFANT Labs, Marietta GA, USA).

[0020] Another study is the invention that is the subject of the patent application number WO2021084524A1. The invention discloses an loT-enabled, portable device that measures intraoral pressure produced by an infant and occurred only during non- nutritional sucking; Intraoral pressure is measured during non-nutritive sucking, and then the measured pressure value is converted into a digital form using a transducer; then transmits the pressure value in digital form using loT (Internet-of-Things) controller to a server and / or to an application and / or a software installed on a smartphone device. The application and / or software installed on the smartphone device which receives the pressure measurement uses an algorithm to produce a stimulus such as music and / or haptic feedback for the premature infant, to train the premature infant to suck optimally; thereby improving self-feeding capability of the premature infant.

[0021] There are also different systems developed to assess tongue force only during sucking / swallowing. However, these systems are widely used not only for a sucking / swallowing assessment but also for a general oral-motor function assessment. One of the requirements for completing the oral phase during sucking / swallowing or creating the necessary intraoral pressure for sucking is the strength of the lip muscles. There are many systems developed to assess that issue. However, for an accurate sucking-swallowing assessment, an assessment which only measures intraoral pressure, tongue movement and / or force is quite limited and insufficient. In addition, breathing coordination during sucking-swallowing, aerodynamic sufficiency, and lip closing force, which is the primary factor to create a sufficient intraoral pressure during swallowing, should also be assessed. The abovementioned systems address these issues individually and do not allow for a comprehensive sucking / swallowing assessment and oral-motor assessment. Consequently, the need for An oral-motor and sucking-swallowing assessment device, which eliminates the disadvantages of the present art, and the inadequacy of the existing solutions have made it necessary to make a development in the relevant technical field.

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[0070] Brief Description of the Invention

[0071] The present invention relates to a device for an accurate and comprehensive oralmotor and sucking-swallowing assessment, which meets the above-mentioned requirements, eliminates all disadvantages and provides some additional advantages, wherein the device simultaneously assesses the negative intraoral pressure during sucking, the expression pressure which is the compression between the tongue and palatine during sucking, and the breathing coordination before, during and after a sucking / swallowing behavior. In addition, the device includes different heads that allow the lip force and blowing abilities to be assessed. Unlike all other systems, a head which aims to assess the sucking-swallowing and breathing coordination was designed for the first time, allowing the sucking-swallowing and breathing coordination to be assessed.

[0072] The object of the invention based on the state of the art is to provide a user-friendly, reliable and non-invasive tool which may objectively measure the coordination between sucking, swallowing and breathing and provide remote monitoring for the family and / or clinician. In addition, an object is also to provide a device which may allow remote monitoring due to its remote monitoring system and KVKK compliant data security protocols and will enable the clinician and the client / patient to share the data instantly and the clinician to access old data from all mobile devices with Internet access. Thanks to the loT integration of the system, the recording waves of historical and / or current measurements may be observed at any time or in any environment, via any smart device (with an Internet connection) without the need for any external equipment. This may also be a part of the application process of the exercises recommended for the rehabilitation of dry swallowing or sucking abilities of children with swallowing and / or sucking disorders. Thus, a measurement system for the sucking assessment and a system which may be used for a rehabilitation step due to the instant data flow between the family and the clinician, without the need for a hospital visit in case of a possible sucking insufficiency and / or disorder, have been presented. In addition, due to instant data flow, sucking and feeding monitoring of the newborn after discharge may be carried out more regularly and systematically.

[0073] The object of the invention is to provide an accurate and comprehensive oral-motor and sucking-swallowing assessment by simultaneously assessing the negative intraoral pressure during sucking, the expression pressure indicating the compression between the tongue and palate during sucking, and the breathing coordination before, after and during the sucking / swallowing behavior.

[0074] Another object of the invention is to provide a comprehensive motor assessment and assessment of the aerodynamic capacity of a child at older ages (during preschool period) by measuring the lip closing force required to blow and create sufficient intraoral pressure.

[0075] A further object of the invention is to enable a comprehensive oral-motor assessment thanks to a single main body and different designed heads of the device.

[0076] Another object of the invention is to provide remote monitoring of data and remote control of the system, due to the IOT integration.

[0077] Another object of the invention is to allow the device to be used by caregivers at home, or by clinicians providing therapy / treatment services in a clinical setting, for the therapy / treatment follow-up of pediatric, adult and geriatric groups who have advanced neurological, motor disorders, and / or who can only take liquid foods.

[0078] The structural and characteristic features and all advantages of the invention will be understood more clearly with the figures provided below and the detailed description provided with reference to those figures, and thus, the evaluation should be made by taking these figures and the detailed descriptions into consideration.

[0079] Brief Description of the Drawings

[0080] In order to better understand the embodiment and the advantages of the present invention with additional components, it should be evaluated together with the figures described below.

[0081] Fig.-1 is a schematic overview of the device with a sucking / swallowing positive expression pressure measuring head,

[0082] Fig. -2 is a schematic overview of the aerodynamic measuring hose / head and the sucking / swallowing and breathing control measuring head on the device,

[0083] Fig. -3 is a schematic overview of the disassembled main body,

[0084] Fig. -4 is a schematic overview of the disassembled microcontroller,

[0085] Fig. -5 is a work flow diagram of the device,

[0086] Fig. -6 is a schematic overview of the analysis interface,

[0087] Fig. -7 is a screen shot of the sucking analysis, lip force analysis and expression analysis, Fig. -8 is a screen shot of the blowing analysis and sucking-breathing coordination analysis,

[0088] Fig. -9 is a detail view of the head intermediate body,

[0089] Fig. -10 is a schematic overview of the disassembled head intermediate body,

[0090] Fig. -11a is a schematic overview of the implementation of the device,

[0091] Fig.- 11b is a schematic overview of the implementation of the device in a different perspective,

[0092] Fig. -12 is a detail view of the lip closing force measuring head,

[0093] Fig. -13 is a detail view of the disassembled lip closing force measuring head,

[0094] Fig. -14a is a schematic overview of the sucking / swallowing negative pressure measuring head,

[0095] Fig. -14b is a schematic overview of the sucking / swallowing negative pressure measuring head in a different perspective,

[0096] Fig. -15 is a detailed schematic overview of the sucking / swallowing negative pressure measuring head,

[0097] Fig. -16 is a schematic overview of the disassembled sucking / swallowing negative pressure measuring head,

[0098] Fig. -17a is a schematic overview of the sucking / swallowing positive expression measuring head,

[0099] Fig. -17b is a schematic overview of the sucking / swallowing positive expression measuring head in a different perspective,

[0100] Fig. -18 is a detailed schematic overview of the sucking / swallowing positive expression measuring head,

[0101] Fig. -19 is a schematic overview of the disassembled sucking / swallowing positive expression measuring head,

[0102] Fig. -20a is an implementation schematic overview of the aerodynamic measuring hose / head,

[0103] Fig. -20b is a schematic overview of the implementation of the aerodynamic measuring hose / head in a different perspective,

[0104] Fig. -21 is a detailed schematic overview of the aerodynamic measuring hose / head,

[0105] Fig. -22 is an schematic overview of the disassembled aerodynamic measuring hose / head,

[0106] Fig. -23a is a schematic overview of the sucking / swallowing and breathing control measuring head, Fig.- 23b is a schematic overview of the sucking / swallowing and breathing control measuring head in a different perspective,

[0107] Fig. -24 is a schematic overview of the sucking / swallowing and breathing control measuring head,

[0108] Fig. -25 is a schematic overview of the sucking / swallowing and breathing control measuring head in a different perspective,

[0109] Fig. -26 is a schematic overview of the disassembled sucking / swallowing and breathing control measuring head,

[0110] Fig. -27 is a detail view of the nasal sensor interconnection hose on the separator plate, Fig. -28 is a detail view of the perforated pacifier head and nasal pressure sensor.

[0111] Reference Numerals

[0112] 100. Device

[0113] 110. Main body

[0114] 111. Plastic housing box

[0115] 112. Battery chamber

[0116] 113. Microcontroller

[0117] 114. Voltage regulator

[0118] 115. Connector thread

[0119] 116. Turn on-off switch

[0120] 117. Charging module

[0121] 120. Head connecting cable

[0122] 130. Head intermediate body

[0123] 131. Interconnection

[0124] 1311. Interconnection upper cover

[0125] 1312. Interconnection body

[0126] 1313. Interconnection lower cover

[0127] 132. Handle upper cover

[0128] 133. Handle body

[0129] 134. Pressure sensor

[0130] 1341. Sensor connecting hose

[0131] 135. Handle lower cover

[0132] 140. Lip closing force measuring head

[0133] 141. Plastic bulb 142. Head connecting hose

[0134] 150. Sucking / swallowing negative pressure measuring head

[0135] 151. Perforated pacifier

[0136] 152. Pacifier-sensor interconnection hose

[0137] 153. Head connecting ring

[0138] 160. Sucking / swallowing positive expression pressure measuring head

[0139] 161. Non-perforated pacifier

[0140] 162. Non-perforated head connecting ring

[0141] 163. Non-perforated pacifier-sensor interconnection hose

[0142] 170. Aerodynamic measuring hose / head

[0143] 180. Sucking / swallowing and breathing control measuring head

[0144] 181. Two-chamber Rothenberg mask

[0145] 182. Perforated pacifier head

[0146] 183. Y-tube

[0147] 184. Nasal / nostril pad

[0148] 185. Nasal sensor interconnection hose

[0149] 186. Separator plate

[0150] 187. Oral sensor interconnection hose

[0151] 188. Head stabilizer

[0152] 189. Oral pressure sensor

[0153] 190. Nasal pressure sensor

[0154] 191. Sensor stabilizer

[0155] 200. Work flow diagram

[0156] 210. Start

[0157] 220. Connection control

[0158] 230. Transmission of data to the server and data security protocols

[0159] 240. Result indicator

[0160] 300. Analysis interface

[0161] 310. Sucking analysis

[0162] 320. Lip force analysis

[0163] 330. expression analysis

[0164] 340. Blowing analysis

[0165] 350. Sucking-breathing coordination analysis

[0166] Detailed Description of the Invention In this detailed description, the device (100) for an accurate and comprehensive oralmotor and sucking-swallowing assessment of the invention is described only as an example for a better understanding of the subject in a non-limiting sense, wherein the device simultaneously assesses the negative intraoral pressure during sucking, the expression pressure which is the compression between the tongue and palatine during sucking, and the breathing coordination before, during and after a sucking / swallowing behavior.

[0167] Achievement of independent oral feeding of the newborn has been accepted by the American Academy of Pediatrics as one of the criteria for hospital discharge (American Academy of Pediatrics, 2008). Therefore, the transition of infants to independent feeding is an important factor affecting the length of hospital stay (Lau, 2016). Additionally, infants with feeding difficulties are at risk for feeding-related readmissions, such as failure to thrive, resulting in increased healthcare costs (Underwood et al., 2007). Therefore, not only oral feeding is an essential requirement for most infants before discharge from the neonatal intensive care unit, but also developing these skills is also a factor for the growth and developmental success in the future (Azuma and Maron, 2020). Therefore, assessing the sucking ability of newborns is thought to be very important for the assessment of the infant's neuro-motor function. Therefore, it would be very valuable for this assessment to be carried out by a measurement device that is easy to use, non-invasive and may provide objective results. In addition, it is predicted that as the sucking is assessed, both the rate of hospital readmission due to nutritional disorders may be reduced and the workload of neonatal clinicians may be reduced by means of the remote monitoring system. Considering all these factors, the device (100) of the invention has been developed to assess in detail the infant's sucking and other oral motor functions in later stages and to also respond to remote monitoring service.

[0168] Fig.-1 shows a system with more than one measuring heads, which is designed for an oral-motor assessment. The device (100) comprises a main body (110) containing a microcontroller (113); a head connecting cable (120) which integrates different measurement heads with the main body (110) and has Type-C male and female ends; a head intermediate body (130) into which different measuring heads may be integrated, such as a lip closing force measuring head (140), a sucking / swallowing negative pressure measuring head (150), a sucking / swallowing positive expression pressure measuring head (160). The main body (110) is connected to the main measuring heads specially designed for the device (100) via said connecting cable (120). The measuring heads allow the measurement of different skills, and they perform this function by means of the pressure sensors therein. An aerodynamic measuring hose / head (170) or a suction / swallowing and breathing control measuring head (180)may also be integrated into the head intermediate body (130) located in the main body (110) shown in Fig. -2..

[0169] The main body (110) shown in Fig. -3 consists of a plastic electrolyte housing box (111) to protect, organize and isolate all components in the circuit in the main body (110) from external factors; a battery chamber (112) in which the battery providing the energy needed for the device (100) to operate is located; a microcontroller (113); a voltage regulator (114) shown in fig. -4; two connector threads (115) for a head input and charging input; a turn on-off switch (116) which enables the device (100) to be turned on and off, and a charging module (117) showing the charging status. In said device (100), a NodeMCU ESP32 microcontroller (113) is used as the processor. This microcontroller (113) was preferred due to its low power consumption and high processing power. It reads data from the sensors, processes these data and allows the device (100) to establish a wireless connection and transfers the data to a remote server. ESP32 is a solution often used in loT projects due to a broad range of wireless connection options, the low power consumption and the powerful processing capabilities thereof. When the features and functions of ESP32 are examined, the micro-controller (113) ESP32 has a microcontroller with a low power consumption and a high performance. Wireless connectivity supports wireless communication protocols such as ESP32, Wi-Fi and Bluetooth. In this way, it is possible to remotely control the device (100) or transfer data via a mobile application or the Internet. Input / output pins, ESP32 has various input / output pins. These pins allow the connection and control of the external components (sensors, motors, LEDs, etc.). When the components on the NodeMCU ESP32 board are examined, the NodeMCU ESP32 board has some additional components in addition to the ESP32 microcontroller. These are: a USB interface (NodeMCU ESP32 board connects with the computer for programming and communication via the USB interface); power connections (There are suitable locations on the board for external power supply or battery connection); an integrated antenna (The NodeMCU ESP32 board has an integrated antenna and may efficiently receive and transmit wireless communication signals.). 18650 3.3V 2000mAh battery chamber (112) is the power source of the device (100). This battery uses a lithium-ion technology and has a high energy density. The battery is charged via a TP5100 charging module (117). The charging module uses constant current and constant voltage method to charge the battery accurately. The MT3608 2A voltage regulator (114) controls the output voltage of the battery and makes it compatible with the ESP32-WROOM microcontroller (113). The voltage regulator (114) is preferred due to the high efficiency and low heat loss thereof. In this context, the MT3608 2A voltage regulator (114) meets the voltage requirements of the device (100). The turn on-off switch (116) is used for energy control of the circuit. While one pin of the connections leads to the battery chamber (112), the other pin is connected to the voltage regulator (114). Type-C connector threads (115) are used to integrate the device (100) with the external sensor heads. While one of the connector threads (115) connects with the Esp32 microcontroller (113), the other one connects with the charging module (117). In this way, the first of the connector threads (115) is integrated with the input sensor heads, while the other one is used to charge the device (100).

[0170] As can be seen from the device work flow diagram (200) showing the operating principle of the device (100) shown in Fig. -5, the device (100) is operated by turning it on (210), then the connection control (220) is performed, then the data is transferred to the server and the data security protocols (230) are performed, and finally the results (340) are displayed. Displaying (340) the results is carried out on the display of the mobile device through the analysis interface (300) shown in fig. -6. The sucking analysis (310), including the analysis of the sucking function shown in fig. -7, the lip force analysis (320), including the analysis of the lip force function, the expression analysis (330), including the analysis of the expression function, the blowing analysis (340), including the analysis of the blowing function shown in fig. -8, and the sucking-breathing coordination analysis (350), including the analysis of the sucking-breathing coordination function, are displayed aia said analysis interface (300).

[0171] The head intermediate body (130) shown in Fig. -9 comprises an interconnection (131) for integrating different measuring heads into the head intermediate body (130); a handle upper cover (132); a handle body (133) for ease of use and easier hand grip during measurement; a pressure sensor (134), and a handle lower cover (135). The interconnection (131) shown in Fig. -10 has a clawed interconnection upper cover (1311) and interconnection lower cover (1313) to better grip the measuring heads, and a main connection body (1312) into which said interconnection upper cover (1311) and interconnection lower cover (1313) are integrated. Said pressure sensor (134) is connected via a sensor connecting hose (1341). Due to the handle body (133), the heads may be held during measurement. The MPX5100DP pressure sensor (134) is located in this handle body (133). The pressure sensor (134) changes the resistance depending on the pressure, due to a piezoresistive measuring element therein. The internal structure of the pressure sensor (134) includes a compartment and measuring element exposed to pressure. Pressure acts on this compartment and causes a mechanical deformation. The piezoresistive measuring element detects this deformation and a change in its resistance occurs. This change results in a significant change in voltage at the output terminal of the pressure sensor (134). Thus, the pressure is measured with the voltage value changing depending on the pressure.

[0172] In a preferred embodiment of the invention, the lip closing force measuring head (140) is connected to the head intermediate body (130) shown in Fig.-11 a and Fig. -11b. The lip closing force measuring head (140) shown in Fig. -12 and Fig. -13 is integrated into the head intermediate body (130). The integration is provided by the head connecting hose (142). This head connecting hose (142) is compatible with the interconnection (131). Due to the air-filled plastic bulb (141), the air compressed by the lips is measured by the sensor. Thus, the force applied by the lips to close may be measured in units of pressure.

[0173] In a preferred embodiment of the invention, the sucking / swallowing negative pressure measuring head (150) is connected to the head intermediate body (130) shown in Fig.- 14a and Fig. -14b. The sucking / swallowing negative pressure measuring head (150) shown in Fig. -15 and Fig. -16 is integrated into the head intermediate body (130). The sucking / swallowing negative pressure measuring head (150) is directly integrated into the handle body (133) via the head connecting ring (153). The negative pressure formed in the mouth during sucking / swallowing can be measured by the perforated pacifier (151). The negative pressure changes during sucking / swallowing are integrated into the sensor connecting hose (1341) and then into the pressure sensor (134) by the pacifier-sensor interconnection hose (152). In a preferred embodiment of the invention, the sucking / swallowing positive expression pressure measuring head (160) is connected to the head intermediate body (130) shown in Fig. -17a and Fig. -17b. The sucking / swallowing positive expression pressure measuring head (160) shown in Fig. -18 and Fig. -19 is integrated into the head intermediate body (130). The integration is directly made to the handle body (133) by the non-perforated head connecting ring (162). The compression force between the tongue and palate during sucking / swallowing can be measured by the non-perforated pacifier (161). This type of pressure is called expression pressure. The positive pressure changes during expression are integrated into the sensor connecting hose (1341) and then into the pressure sensor (134) by the non-perforated pacifier-sensor interconnection hose (163).

[0174] In a preferred embodiment of the invention, the aerodynamic measuring hose / head (170) is connected to the head intermediate body (130) shown in Fig. -20a and Fig.- 20b. The aerodynamic measuring hose / head (170) shown in Fig. -21 and Fig. -22 consists of a single piece and is directly integrated into the interconnection upper cover (1311). The aerodynamic measuring tube / head (170) enables the measurement of air coming directly from the lungs and blown under pressure.

[0175] In a preferred embodiment of the invention, the sucking / swallowing and breathing control measuring head (180) is connected to the head intermediate body (130) shown in Fig. -23a and Fig. -23b. The sucking / swallowing and breathing control measuring head (180) shown in fig. -24, fig. -25 and fig. -26 comprises a two-chamber Rotenberg mask (181), a perforated pacifier head (182), and a y-tube (183). The sucking / swallowing and breathing control measuring head (180) shown in fig. -27 and fig. -28 also includes a nasal / nostril pad (184), a nasal sensor interconnection hose (185), a sensor plate (186), an oral sensor interconnection hose (187), a head stabilizer (188), an oral pressure sensor (189), a nasal pressure sensor (190), and a sensor stabilizer (191). Unlike the other measuring heads, the sucking / swallowing and breathing control measuring head (180) is not connected to the head intermediate body (130). Therefore, the measuring sensors are located in the sucking / swallowing and breathing control measuring head (180). There are 2 different sensors, the oral pressure sensor (189) and the nasal pressure sensor (190), in the sucking / swallowing and breathing control measuring head (180). The connection of the oral pressure sensor (189) and nasal pressure sensor (190) is combined and connected to the connection extension cable (120) and the main body (110). It has a separator plate (186) between the two-chamber Rotenberg mask (181) to isolate the oral and nasal zones from each other. In this way, the two-chamber Rotenberg mask (181) is divided into two different chambers: an oral and nasal zone. The nasal / nostril pad (184) is integrated into the nostril and made into a single piece by means of the y-tube (183). The nasal sensor interconnection hose (185) is then integrated into the nasal pressure sensor (190). In this way, an assembly is provided to record the breathing pattern during the sucking-swallowing-breathing cycle. In order to record sucking / swallowing, a perforated pacifier head (182) is integrated into the oral chamber of the mask. Thus, the negative pressure changes during sucking / swallowing may be recorded. The connection between said sucking / swallowing and breathing control measuring head (180) and the oral pressure sensor (189) is made with the oral sensor interconnection hose (187). The perforated pacifier head (182) is fixed to the oral chamber via the head stabilizer (188). The sensors are fixed to the separator plate (186) by the sensor stabilizers (191). As a result, the exhalation behavior during and after sucking / swallowing maybe monitored by the sucking / swallowing and breathing control measuring head (180).

[0176] According to the circuit diagram steps of the device (100):

[0177] Firstly, energy is provided to the system. 18650 batteries located in the battery chamber (112) is used as the power source of the system. The system also has a second connector thread (115) (Type C) for charging. The DC voltage obtained in the battery is connected to the energy input on the circuit. The energy is then transmitted to the voltage regulator (114) via the charging module (117). The voltage regulator (114) regulates the energy provided and stabilizes the same to a certain voltage level. This step is important to ensure a stable and suitable power supply. The voltage regulator (114) feeds the ESP32 microcontroller (113) and the sensor located in the external measuring heads. ESP32 is a powerful microcontroller unit with the integrated WiFi and Bluetooth capabilities.

[0178] The steps of the work flow diagram (200) of the device (100) are as follows:

[0179] During the start (210) step when the system is started, all components and connections are made ready, and the necessary numerical data are obtained by converting the data obtained through the processes detailed in the device circuit diagram from the pressure sensor by the ADC.

[0180] During the Connection Control (220) step, the ESP32 scans for Wi-Fi networks and selects a network to connect to the server. It tries to connect to a predefined Wi-Fi network. If the connection fails, it tries again and repeats this step until it connects. When the connection is successful, the ESP32 connects to the server and logs in with the user account.

[0181] During the step of Data Transmission to the Server and Data Security Protocols (230), the MQTT (Message Queuing Telemetry Transport) is a messaging protocol. It is especially widely used in loT (Internet of things) applications. MQTT is frequently used to provide an efficient communication in networks with a low bandwidth and a high latency. In this context, the basic structures of MQTT consist of three components: a client, a broker and a publish / subscribe pattern. The client represents a device that produces or receives data. The broker is a middle-ware that manages the communication. The publish / subscribe pattern is a structure where the clients may subscribe to certain topics and listen to publications. As a matter of fact, MQTT works with a publish / subscribe pattern. The clients may publish on a particular topic and other clients may listen to that publication. The communication between the client and the broker is accomplished using a lightweight message format. This message format allows data to be transported quickly and the network traffic to be minimized. The broker receives MQTT messages, processes them and delivers them to the subscribers. The clients connect with the broker and may subscribe to a particular topic or publish. The broker receives subscribers' messages and may forward them to the relevant clients. In this way, the data is shared effectively. Briefly, the MQTT is a lightweight messaging protocol, and the broker is a middle-ware that manages the MQTT messages. By the publish / subscribe pattern of the MQTT, the data sharing may be easily achieved in the loT applications. In this context, given the reasons for choosing the MQTT protocol in this device, it has advantages such as low resource consumption, easy applicability, security and scalability. Therefore, it is a frequently preferred protocol in the loT (Internet-of-things) applications. A reliable and efficient communication may be achieved by using MQTT and brokers in various scenarios such as data collection, remote control, sensor networks. loT is an application running on the ESP32 microcontroller (113). Esp32, on the other hand, uses Wi-Fi technology for data communication. In this way, the Esp32 device transmits data to the AWS (Amazon Web Services) cloud platform. During data transmission, the MQTT (Message Queuing Telemetry Transport) protocol is used. MQTT is a lightweight messaging protocol and preferred for exchanging data between loT devices. By this protocol, data is transmitted to the server in a safe and quick manner. Data security is an important issue, and security measures have been taken on the device. Data is encrypted using strong encryption algorithms such as AES (Advanced Encryption Standard). In this way, the security and confidentiality of the data is ensured. Furthermore, Wi-Fi connection supports security protocols such as WPA2 (Wi-Fi Protected Access 2), so the network connection is secured. The data collected from our device is transferred to the AWS loT Core service. AWS loT Core is a cloud platform that enables loT devices to be securely connected and the data to be collected and managed. Data is processed by AWS loT Core, stored and recorded in a database accessible to the relevant clinicians. This database allows the clinicians to review and analyze patients' sucking and swallowing data. The information in the loT 2 Database is important for the accurate diagnosis and treatment processes of the clinicians. The data associated with information such as the patient's name and surname are used to create a patient file and ensure follow-up. Thus, the clinicians may monitor patients' health status, optimize treatment processes and intervene when necessary. The data collected by the sensor and Esp32 is securely transmitted to the AWS server and stored in a database accessible to the clinicians. In this way, changes in infants' sucking and swallowing force may be monitored, their health status may be monitored, and their development may be analyzed.

[0182] In order for the system to be KVKK compliant and to ensure data security, the data collected by the device (100) is encrypted and stored on Microsoft Azure / Amazon AWS servers. In this context, even if the data is stolen, there will be no access to any information as it is encrypted.

[0183] Accordingly, data security is of great importance in the design of loT devices. There are a number of protocols used to ensure data security of these devices. One of them, the WiFi Manager library, is the Arduino library for the microcontrollers such as ESP8266 and ESP32. By this library, the device may be connected to a WiFi network, and the configuration settings may be stored. In this way, the device may easily connect to different WiFi networks and the settings thereof are saved. Additionally, the WiFi Manager library provides a user-friendly web interface, so the users may easily change WiFi settings.

[0184] Another protocol is the OTA (Over-The-Air) protocol. This is a protocol which allows a device to receive firmware updates wirelessly. The OTA protocol allows the users to install the latest updates on their devices, provided the devices are connected to the wireless networks. This protocol includes a number of techniques used to ensure security. These techniques include encryption and signing of the updates, and the other security measures. In this way, the security of devices may be protected during OTA updates. The device developed in this context includes both protocols.

[0185] The device (100) is currently used as a server provider with loT integration on the Bylink platform (a demo application). However, a professional service may also be received through a server provider which belongs entirely to the device (100).

[0186] During the step of Result Display (240), the data collected from the sensors is sent to the server. In this way, the user may instantly track data via any mobile device, or then, access old archived data. The details about the result display and user interface are included. The analysis interface (300) contains all options regarding the intended subanalysis. After the relevant measuring head is attached, the relevant sub-measurement is selected on the home screen and then recorded. The measurement for the sucking analysis (310) measures the non-nutritive sucking by the negative pressure measuring head (150). The measurement for the expression analysis (330) measures the expression pressure, and this is carried out by the sucking / swallowing positive expression pressure measuring head (160). The measurement made for the lip force analysis (320) measures the lip closing force by the lip closing force measuring head (140). The measurement for the blowing analysis (340) measures the air flow during blowing, and this is carried out by the aerodynamic measuring hose / head (170). Finally, the measurement for the sucking-breathing coordination analysis (350) is carried out by the sucking / swallowing and breathing control measuring head (180) designed with dual pressure sensors in order to assess the sucking and breathing coordination together. Different heads containing pressure sensors used for measurement are designed for different purposes, and there are 5 different measurement heads in total. Different heads may be designed and integrated into the system depending on the measurement purpose. In this context, except for the suction / swallowing and breathing control measuring head (180), the remaining measuring heads are integrated into the head intermediate body (130), and the signals are sent to the main body (110) via the head connection cable (120) by the pressure sensor located in this intermediate body (130).

[0187] The sensor has an analog output during the step of data transmission to the server and data security protocols (230). The output voltage of the sensor is connected to the analog-to-digital converter (ADC) so that it may be read by the ESP32. ADC converts the analog signal into a digital format and then into data that the ESP32 may understand. During this conversion process, the analog voltage value from the sensor is measured at regular intervals by a sampling method and converted into a numerical value. By processing this digital data, ESP32 obtains information about the sucking force and performs the necessary processes.

[0188] The equation used to process data from an analog sensor in Arduino and calculate the result in kilopascal (kPa) unit is given below:

[0189] 'float sensorValue = ((analogRead(36) * ADC_mV - SensorOffset) / sensitivity * mmh2O_kpa);'

[0190] In the context of Electronic Terms, Piezoresistive Measuring Element: is a component, the resistance of which changes depending on the piezoelectric effect. When exposed to pressure, the resistance thereof changes due to deformation in the crystal structure. The Analog-digital Converter (ADC): is an electronic component which converts the analog signals into a digital form. It converts the analog voltage value from the sensor into digital data by sampling at a certain resolution. Sampling: is a process of measuring an analog signal at certain intervals and obtaining sample values at certain period of times. The sampling frequency determines how often the signal is measured and affects the resolution of the ADC. The pressure sensor (134) is connected to the other measuring heads via the sensor connecting hose (1341). The sensor connecting hose (1341) is a hollow hose designed to have a width enough to accommodate the pressure sensor (134) inlet and is positioned inside the handle body (133). The upper end of the sensor connecting hose (1341) leads to the level of the upper cover (1311) of the handle body and the interconnection lower cover (1313). The lower end of the sensor connecting hose (1341) ends at the pressure sensor (134). The existing pressure sensor (134) is integrated into the lower cover (135) of the handle body and the connection end is exposed to the outside. In this way, the measuring heads are connected to the main body (110) by the connecting cable (120).

Claims

CLAIMS1. A device (100) for an accurate and comprehensive oral-motor and suckingswallowing assessment, wherein the device simultaneously assesses the negative intraoral pressure during sucking, the expression pressure which is the compression between the tongue and palatine during sucking, and the breathing coordination before, during and after a sucking / swallowing behavior, characterized in that it comprises: two connector threads (115) for a head input and a charging input, to integrate the device (100) with the external sensor heads; an analysis interface (300) for displaying (340) the results via a display of a mobile device after the data transportation to a server and the data security protocols (230) are performed, subsequent to the control (220) of the connections; a lip-closing force measuring head (140) which is integrated into a head intermediate body (130) to measure the force applied by the lips for closing in units of pressure; and / or a sucking / swallowing positive expression pressure measuring head (160) which is integrated into a head intermediate body (130) to measure the compression force between the tongue and palate during sucking / swallowing; and / or a sucking / swallowing and breathing control measuring head (180) to track the exhalation behavior during and after sucking / swallowing, in which the measuring sensors are present.

2. The device (100) according to claim 1, characterized in that it comprises a main body (110) in which a microcontroller (113) is located.

3. The device (100) according to claim 1, characterized in that it comprises a head connecting cable (120) which integrates different measurement heads with the main body (110) and has Type-C male and female ends.

4. The device (100) according to claim 1 , characterized in that it comprises a battery chamber (112) in which the battery providing the energy needed for the device (100) to operate is located.

5. The device (100) according to claim 1, characterized in that it comprises a microcontroller (113) to read data from the sensors, process these data, and allow the device (100) to establish a wireless connection and transfer the data to a remote server.

6. The device (100) according to claim 1, characterized in that it comprises a voltage regulator (114) to control an output voltage of the battery and make it compatible with the microcontroller (113).

7. The device (100) according to claim 1, characterized in that it comprises an expression analysis (330) which includes an analysis of the expression function displayed via the analysis interface (300).

8. The device (100) according to claim 1, characterized in that it comprises a sucking-breathing coordination analysis (350) which includes an analysis of the sucking-breathing coordination function displayed via the analysis interface (300).

9. The device (100) according to claim 1, characterized in that it comprises a head intermediate body (130) to integrate different measuring heads such as a lipclosing force measuring head (140), a sucking / swallowing negative pressure measuring head (150), or a sucking / swallowing positive expression pressure measuring head (160).

10. The device (100) according to claim 9, characterized in that it comprises an interconnection (131) for integrating different measuring heads into the head intermediate body (130).

11. The device (100) according to claim 10, characterized in that it comprises a claw interconnection upper cover (1311) and interconnection lower cover (1313) to better grip the measuring heads.

12. The device (100) according to claim 10, characterized in that it comprises a main connecting body (1312) into which the interconnection upper cover (1311) and the interconnection lower cover (1313) are integrated.

13. The device (100) according to claim 9, characterized in that it comprises an upper handle cover (132).

14. The device (100) according to claim 9, characterized in that it comprises a handle body (133) for ease of use during measurement and for an easier hand grip.

15. The device (100) according to claim 9, characterized in that it comprises a lower handle cover (135).

16. The device (100) according to claim 1, characterized in that it comprises an airfilled plastic bulb (141) to measure the air compressed by the lips by a sensor.

17. The device (100) according to claim 1, characterized in that it comprises a head connecting hose (142) to integrate the lip closing force measuring head (140) into the head intermediate body (130).

18. The device (100) according to claim 1 , characterized in that it comprises a sucking / swallowing negative pressure measuring head (150) integrated into the head intermediate body (130).

19. The device (100) according to claim 18, characterized in that it comprises a head connecting ring (153) to integrate the sucking / swallowing negative pressure measuring head (150) directly into the handle body (133).

20. The device (100) according to claim 18, characterized in that it comprises a pacifier-sensor interconnection hose (152) to integrate the negative pressure changes during sucking / swallowing into the sensor connecting hose (1341) and then into the pressure sensor (134).

21. The device (100) according to claim 1, characterized in that it comprises a nonperforated pacifier (161) to measure the compression force between the tongue and palate during sucking / swallowing.

22. The device (100) according to claim 1 characterized in that it comprises a nonperforated head connecting ring (162) to integrate the sucking / swallowing positive expression pressure measuring head (160) directly into the handle body (133).

23. The device (100) according to claim 1, characterized in that it comprises a nonperforated pacifier-sensor interconnection hose (163) to integrate the positive pressure changes during expression into the sensor connecting hose (1341) and then into the pressure sensor (134).

24. The device (100) according to claim 1, characterized in that it comprises an aerodynamic measuring hose / head (170) which consists of a single piece and is directly integrated into the interconnection upper cover (1311), for measuring the air coming directly from the lungs and blown under pressure.

25. The device (100) according to claim 1 , characterized in that it comprises a nasal sensor interconnection hose (185) integrated into a nasal pressure sensor (190) to record the breathing pattern during a sucking-swallowing-breathing cycle.

26. The device (100) according to claim 1, characterized in that it comprises an oral sensor interconnection hose (187) which connects the sucking / swallowing and breathing control measuring head (180) and the oral pressure sensor (189).

27. The device (100) according to claim 1, characterized in that it comprises a head stabilizer (188) to fix the perforated pacifier head (182) to the oral cabin.

28. The device (100) according to claim 1, characterized in that it comprises an oral pressure sensor (189) and a nasal pressure sensor (190), which are positioned in the sucking / swallowing and breathing control measuring head (180) and are connected together to a connection extension cable (120) and the main body (110).

29. The device (100) according to claim 1, characterized in that it comprises sensor stabilizers (191) to fix the sensors to a separator plate (186).

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