ANATOMICALLY COMFORTABLE WEARABLE NECK ULTRASOUND PATCH SYSTEM AND METHOD
Patent Information
- Authority / Receiving Office
- TR · TR
- Patent Type
- Applications
- Current Assignee / Owner
- DATASURGERY YAZILIM & DANIŞMANLIK ANONİM ŞİRKETİ
- Filing Date
- 2026-05-20
- Publication Date
- 2026-06-22
Smart Images
Figure 00000012_0000
Abstract
Description
1 TARIFF ANATOMICALLY COMFORTABLE WEARABLE NECK ULTRASOUND PATCH SYSTEM AND METHOD Technical Area This invention is in the field of medical imaging systems, specifically using ultrasonography. Detection of thyroid nodules and malignancy risk analysis can be performed with anatomical ease. 5 This relates to the wearable neck ultrasound patch system and method. Previous Technique Thyroid nodules are now largely detected using ultrasonography. However, This process requires manual scanning by the operator, resulting in low repeatability. It has significant disadvantages, such as being open to subjective evaluation. 10 Even with increasing capabilities of ultrasound devices, the operator's imaging skills and the individual needs of each patient remain the same. The amount of time spent on this can vary. In addition, current systems require the operator to mark specific areas for nodule detection. It is necessary. If there are multiple nodules, their marking cannot be done automatically. The images obtained are generally static, and video-based analysis is limited; clinical decision-making is 15. Support systems operate based on limited parameters. Ultrasonic patch systems, developed to partially overcome these drawbacks, are described in the literature. While they exist, they are generally focused on a specific region. This type of equipment... None of them provide systematic screening of the entire neck region, specific to the disease. It is unable to perform parameter optimization and AI-assisted malignancy analysis 20 It is unable to accomplish this. The technique is described in the US patent application number US2019065489, which concerns a patient's skin. The invention being discussed is an adhesive patch probe. This invention involves a matrix-shaped... Thanks to the arranged probe cells, regional measurements can be taken. However, this invention... Because it does not have optimization specific to the thyroid, full neck comprehensive, systematic screening 25 It is unable to do so. Furthermore, there is no information regarding performing AI analysis for malignancy with multiple nodules. This development is not mentioned in this application, which was submitted in 2017. 2 Brief Description of the Invention The aim of this invention is to automatically detect thyroid nodules without operator intervention. The goal is to develop a skin-based adhesive patch probe system that will enable this. A complete ultrasound imaging system covering the entire neck area during the procedure. And another objective of the invention is to enable the realization of reproducible imaging. 5 The invention also allows for the simultaneous analysis of multiple nodules thanks to an adhesive patch. Measurements can be taken at different frequencies and using different scanning methods without shifting in the scanned area. The aim is to repeat the process. The data obtained and the ultrasound results are returned to the operator. The invention will enable the creation of artificial intelligence training data along with its notifications. Furthermore... Thanks to the relevant dataset, the risk of malignancy over time can be predicted with high accuracy using artificial intelligence. This determination will again be possible with a patch probe. Definitions of the Figures Illustrating the Invention To better explain the invention, the ultrasonic neck patch system developed with this invention is... The diagram used and the related explanations are given below. Figure 1 Schematic of the patch element of the ultrasonic neck patch system according to the invention. It is the appearance. The elements shown in the figures are numbered, and their corresponding elements are given below. 1. Ultrasonic patch 2. Probe 3. Connector 20 Detailed Description of the Invention The present invention enables the detection of nodules occurring in the thyroid gland, and the analysis of these nodules. ultrasonic imaging, classification, and monitoring of changes over time. Ultrasonic patch developed for the purpose of monitoring and assessing the risk of malignancy (1) and relates to its method of use. The invention relates, on the one hand, to ultrasound data from the neck region 25 a skin-mountable / wearable body containing numerous probes (2) for obtaining and on the other hand, it processes the data obtained from this hardware to generate clinical decision support. 3 It encompasses the software infrastructure. Therefore, the invention is not merely a display device, also involves interpreting and comparing images and from a medical perspective. It is a comprehensive analytical system that enables interpretation. The main aim of the invention is to move away from the classical operator-dependent approach to thyroid ultrasonography. The goal is to make it more systematic, more repeatable, and more holistic by distancing it from others. 5 Ultrasonography is the most commonly used method for the initial detection of thyroid nodules. However, current In these procedures, the physician or technician places the probe (previously handheld) on the neck. The model must manually move the machine around the relevant area, scanning it visually and through experience. This the situation is such that the examination varies from person to person, some small nodules may be missed, the same the inability to compare the patient's examinations at different times in a standardized manner and 10 In many cases, this leads to subjective differences in interpretation. Especially In patients with multiple nodules, each nodule must be identified separately. sizing, description and risk assessment are further This is becoming more difficult. The current invention aims to overcome these problems by adapting to the anatomy of the neck. to train artificial intelligence with an ultrasonic patch (1) that provides systematic data collection and 15 In the future, this will offer a new platform that operates with the help of artificial intelligence trained on this data. The hardware component of the invention is a flexible ultrasonic patch that can be placed around the neck. (1) constitutes. The patch (1) differs from the classic handheld ultrasound probes. In other words, it does not require the user to continuously scan a specific point manually, and is adapted to the anatomy of the neck. a 20 that adapts and can make contact with all or most of the front neck area. It is structured in such a way that direct adhesion is possible for the patch (1) to be placed on the patient's neck. as is, the patient is placed in a supine position with the exposed neck area, the patient is upright It can also be done by dressing it in a way that wraps around the neck while in that position. (Contact) all elements that are skin-friendly and firming / gripping even in long-term use 25 It should be at a safe level that allows viewing but does not apply unnecessary pressure. will be provided. Because the thyroid gland is located on the front of the neck, relatively close to the skin's surface, With the help of a patch (1) placed in this area, the thyroid tissue and this tissue Systematic visualization of the nodules within it becomes possible. Patch (1) Its flexible structure allows it to adapt to the curved surface of the neck, which varies from patient to patient. 30 4 This enables the provision of continuity of ultrasonic contact and measurement stability. This approach is being increased. This approach is particularly relevant for superficial but anatomically significant areas like the thyroid, such as the right and left sides. Divided into lobes, containing an isthmus region, and surrounded by blood vessels, muscles, lymph nodes, and airways. It allows for a more holistic assessment of an organ with its own structures. Patch (1) contains 5 for generating ultrasound waves and detecting the returning echoes. Elements called piezoelectric-based multi-transducer probes (2) are used. This consists preferably of pMUT type piezoelectric micromechanical ultrasound transducers. probes (2) are able to operate with low voltages and high resolution imaging. It was preferred in this application of the invention because it offers a suitable architecture for this. The converters, in a suitable array of configurations, adapt specifically to the curved geometry of the neck. It is installed via patch (1) in such a way as to provide only a single one. Instead of taking measurements from a single point, a measurement that includes the right and left sides of the neck and the midline can be used. A wide-area and controlled ultrasonic scanning setup is created. Arrangement of probes (2) Its form can be linear, matrix-ordered, curvilinear, phase-arranged, or a combination thereof. This can be done. The main purpose here is to examine 15 lobes of the thyroid gland and the isthmus region. The goal is to ensure that data is collected completely and reproducibly. The texture of the ultrasonic patch (1) can be flexible, rigid or mesh, and it can separate the probes (2) from each other. It could even be a structure that brings them closer together. The aim is to provide the best possible support to the patient's neck area. a patch (1) that grips and positions the probes (2) immobile during measurements It is the development of. 20 To visualize the nodules on the right and left, the ultrasonic patch (1) was placed on both sides. Multiple and preferably 16x16 array pMUT probes (2) with 256 elements will be created. The densely packed structure is not only used to create a wider coverage area, but also By providing higher scanning intensity over time, nodule boundaries, tissue transitions, and It was preferred for more clearly determining local echo differences. Especially thyroid 25 to identify contour irregularities in the nodules that are significant in terms of malignancy It has been preferred. A suitable coupling is required to establish healthy acoustic transmission between the patch (1) and the skin. Standard ultrasound gel will be preferred as the medium. In this way, the patch (1) contains Ultrasound waves emitted from the transducers are effectively transferred to the skin surface, Echoes returning from the tissue can also be detected with sufficient sensitivity. The system only It is not limited to superficial imaging, but also includes imaging of thyroid tissue at different depths. It will operate dynamically in terms of frequency and focusing so that its structures can also be examined. It is designed in this way. 5 In various applications of the invention, instead of classic ultrasound gel and / or in contact with neck layers gel reservoir, hydrogel layer, microfluidic coupling layer to increase You can create the longitudinal layer of the soft layer patch (1). The contact distance of the patch (1) with the skin affects its focusing and data reading capabilities. pressure sensor, contact sensor, impedance or coupling layer quality 10 for enhancement A control element (coupling quality feedback) can be added. This allows for control before and during measurement. During the measurement process, additional data will be collected to improve measurement and prevent measurement errors. Either directly through the hardware such as probe (2) on the patch (1) or manually The data obtained revealed the patient's neck movements and natural movements resulting from physiology. It is also possible to recognize them and filter their effects. 15 In addition, the thickness of the patch (1) is sufficient to provide good acoustic coupling, Small and suitable element pitch, -6 dB bandwidth, suitable beamforming, elevation. It will have features such as plane control and Doppler sensitivity. This will enable the wearable device to... The measurement success of the equipment will be improved. For best contact, the patch (1) body is different. It can be produced from flexible materials. As a result, 20 containing separate left and right probes (2) There could be an active zone and a flexible bridge connection in the middle. One of the key features of the invention is that the imaging is fixed and at a single frequency. This is not done. The system keeps the positions of the probes (2) fixed during scanning. It has a structure that can gradually change its frequency. This allows it to reach deeper tissues. It will also be possible to examine superficial tissues. In short, the subject of the invention is ultrasonic 25 Thanks to the patch (1), different tissue depths can be scanned in the same patient, within the same scan session. It will be able to automatically activate different frequency ranges. This is especially true for thyroid patients. characteristics of the nodules such as size, depth, echogenicity, and the presence of microcalcifications 6 It is necessary because they differ in terms of quality. The invention aims to meet these two needs within the same system. By combining them, it will enable a more effective and adaptive screening process. Due to the superficial location of the thyroid gland, the ultrasonic patch (1) system used in this invention The frequency selection will be in the range of 7 MHz to 15 MHz. The aforementioned frequency value... 5 during live data collection from the patient, either hardware or software-wise. It can be changed. Frequency changes follow a predefined protocol in a specific sequence or... again, using a predefined protocol, a This can be done with the active intervention of a decision support system. More detailed resolution is required. In these cases, the probes (2) operate in a wide frequency range of 18 MHz and above. This will be provided. Thyroid tissue is mostly located approximately 1 cm to 4 cm deep from the skin surface. It is located within this range. Thanks to the preferred high frequencies, it can penetrate up to 6 cm deep. Examinations can be performed with a resolution of up to 0.5 mm. As the frequency increases, the sound wave penetrates the tissue. While the ability to penetrate decreases, the image resolution increases. Especially for small objects. Identification of nodules of varying diameters, millimeter-sized structural irregularities, and microcalcifications. This high frequency will be utilized. The corresponding frequency value corresponds to the technically highest 15. The resolution limit will be a maximum of 0.5 mm in the axial direction and a maximum of 0.5 mm in the lateral direction. Therefore, the ultrasonic patch (1) of the present invention is dependent on a fixed ultrasonic frequency. without being able to evaluate both the superficial and deeper parts of the thyroid region together. By applying gradual frequency changes, it will be able to record data based on location. Only in this way will it be possible to detect any other possible thyroid disorders in the patient. 20 One of the important reasons for choosing the pMUT probe (2) structure in the invention is the classical PZT It allows operation at much lower voltages compared to more complex systems. Very thin. Thanks to the pMUT probe (2) elements with piezoelectric layers, 10 V to 40 V peak-to- A high electric field can be generated in the peak voltage range. The probes (2) are especially suitable for 10 It is intended to operate with CMOS compatible drivers in the range of V to 30 V. Low voltage 25 This operation is particularly necessary and required to reduce heating in high-density systems with 256 channels. The pulse durations corresponding to the frequencies at which the probes (2) operate are also important for nodule imaging. These are factors that directly affect its resolution. The sensor is active in 7 MHz operation. The pulse duration is approximately 75 nanoseconds, and the effective pulse duration is at 15 MHz operation. 7 It is estimated to be approximately 33 nanoseconds. Also, a standard B-mode imaging In its cycle, it has an active transmission time of approximately 100 nanoseconds at around 10 MHz. It has been determined that the pulse duration is kept so short to allow for separation in the depth direction. This will increase the power, or axial resolution, of the probes. The resolution is 0.5 microseconds. Burst-type deliveries will be applied. The pulse duration of the ultrasonic patch (1) is 5 Depending on the frequency, it operates for approximately 30 to 100 nanoseconds, total. The transmission time, as mentioned above, is a very short 0.5 microseconds. It is planned that this will happen in the form of explosions. Thus, the system will have sufficient image quality. This will achieve the desired resolution while also reducing unnecessary energy consumption and heating. With regard to the screening process, the invention is not limited to a single application method, but can be used in 10 different clinical settings. It has been expanded to cover usage scenarios. Accordingly, the system covers the neck area. It will also be able to analyze data using segmented (regional) scanning and scrolling (row-by-row) scanning methods. In the segmented scanning approach, the neck region is divided into specific sub-regions / areas, and each An area is surveyed separately, in a controlled and comparable manner. The selection of these regions... This can be done automatically or as a predefined operator setting. This method depends on the specific needs of the patient. 15 It will be useful for making the primary observation that is heard. Sliding scan is performed along the scanning region where the probes (2) are arranged by the patch (1). It is based on the principle of advancing the scan sequentially. Thus, an uninterrupted process. This allows for visualization of the continuity between anatomical structures. to evaluate and better understand the relationships of nodules with neighboring tissues 20 This will make it possible. The invention covers both approaches within its scope of protection and can be implemented. Accordingly, one of these can be chosen, or both approaches can be used together within the same system. It is available for use. In order to effectively utilize the multi-element pMUT probe (2) array Beamforming will be performed. In the 256-channel beamforming process, each 25 The delay between sensors can be adjusted to be less than 5 nanoseconds. In the preferred application of the invention, phase shift in a 256 sensor pMUT probe array (2) During scanning, the pulse repetition frequency (PRF) is approximately between 5 kHz and 10 kHz. will be selected. After each short transmission, in order to receive the echoes returning from the tissue 8 A specific resting period is allowed. Approximately in the foreseen operating dynamics of the invention. After a 100 nanosecond transmission, the echo is between 60 and 80 microseconds. It will have a return slope. This corresponds to a depth range of approximately 4 cm to 6 cm. Improving the clarity of images at different depths through phase shifting. This will be provided. Focused, clear images from different depths will be obtained from imaging in different phases. 5 This will ensure that it is obtained. On the other hand, artifact management will also help the patient with movement and swallowing. This will also ensure that natural physiological activities such as these are filtered. Ultrasound data collected thanks to the ultrasonic patch (1) is very good for training an artificial intelligence. These will be data sets. For this, only the operator's opinion for the same patient will be obtained from the data received. And matching them with new imaging studies in the advanced stages of the disease is sufficient. In this way, 10 an artificial intelligence that can be trained will process images over time to produce meaningful clinical results. will be enabled to produce it. For this purpose, the ultrasonic patch (1) can be repeated by standardizing the data collection process. It will generate information. In the first stage, ultrasound images or sequential ultrasound via patch (1). The data will be collected. Then, these images will be checked under expert supervision. 15 The assessment will be stored by matching it with the obtained data set. In this way, thyroid evaluation will be carried out over time. artificial tissue has the ability to distinguish between nodules and, if necessary, surrounding anatomical structures. It will be instilled in the intelligence. The goal is for artificial intelligence to perform segmentation from images obtained individually in the future. and then the size, shape, border structure, echogenicity, and internal structure of the detected nodules were determined. 20 Extraction of numerous features such as calcification status, surrounding parenchymal characteristics, and so on. In the final stage, these characteristics will be used to determine the risk level of the nodule. The invention is not limited to the evaluation of a single nodule. Multiple nodules in the same patient. If found, the system can automatically detect each nodule individually. can limit, identify features and separately determine the risk of malignancy 25 It is able to evaluate all multiple nodules systematically and automatically thanks to the invention. It can be analyzed and reported in this way. Especially in existing commercial solutions, multiple nodules While recognition and comprehensive analysis of all nodules simultaneously are lacking, this invention... 9 The aim is to address this deficiency. Images obtained for this purpose... Creating AI training content based on operator-assisted malignancy detection, again This is one of the aims of the invention. With this data, an artificial intelligence can be trained to repeat the same process. more effective malignancy risk thanks to a patch (1) hardware capable of collecting data. It will be possible to detect it. 5 The system not only detects the presence of nodules, but also tracks the progression of the nodules over time. It will also be possible to monitor its changes through repeated measurements. Thus, the growth of the nodule, Its shrinkage, changes in its internal structure, and contour characteristics can be observed. This will allow the invention to be analyzed. It is also possible to create a three-dimensional digital twin of the thyroid gland and the detected nodules. It is configurable. Such a digital twin would show the combined data of the same patient's examinations from different dates. It is an important tool in patient monitoring by allowing comparison through a model. will create. The results obtained from the invention are reported in a format suitable for use by operators / physicians. This will be brought in, and the interpretation of the data obtained through expert supervision will be enhanced. This will especially enable the development of artificial intelligence infrastructure. 15 Physical and acoustic imaging of the ultrasonic transducer according to the material's properties It depends on the preferred dumping method for the data provided by the probes (2) to be meaningful. The material has a Q factor coefficient of approximately 0.5 and a resonance frequency of approximately 10. The preferred bandwidth would be around 20 MHz. Therefore... A structure based on Polydimethylsiloxane (PDMS) is considered as an elastic carrier material. 20 In addition, the neck of the flexible patch (1) is made by using a flexible carrier material similar to PDMS. to better adapt to its anatomy and curve and to position the probes (2) correctly The work will be ensured. After the probes (2) are placed in a curved structure to wrap around the neck, these elements The resulting signals are first routed through the flexible PCB to a coaxial cable 1 to 2 meters long. The FPC cable will reach the connector (3). Direct wired connection via connector (3). It can be done. On the other hand, instead of the connector (3), it can also be done via wireless connection protocols. Transferring data to a PC, tablet, or mobile device requires internet access and a server and cloud infrastructure. It is possible to transfer data. In conclusion, the present invention systematically uses an ultrasonic patch (1) that is compatible with neck anatomy. collecting data, processing this data using different scanning strategies and different frequency levels. It will enrich the process and be able to combine the resulting images in various ways. Furthermore, the obtained images... AI training and subsequent analysis support thanks to repeatable measurement data obtained. This platform is based on classic handheld ultrasound probes and is operator-dependent. and more systematic, compared to practices that can be standardized to a limited extent. It offers the possibility of a repeatable, more comprehensive and more objective evaluation. The same hardware, screening strategy, frequency management, data processing and clinical decision support in time The fact that its components are brought together in a single heuristic unit makes it superior to existing technology. According to [source / organization name], this represents a significant technical advancement. 10 The patch (1) will be in a structure that conforms to the neck curves. Preferably on the superior part of the neck. submental, submandibular and, if necessary, suboccipital areas, and even inferiorly to the parotid space. and the folds, creases and angulations that correspond to the thoracic junction and supraclavicular fossae, It will be an extension. Therefore, it will either have a flexible form field structure or a pre-formed one. Its structure will wrap around the neck. 15 With its flexible bridge structure in the middle section, it allows wearable technology to be displayed on the right and left viewing areas. With the one-piece flexible structure, probe (2) placement will be possible. In addition, the patch in question (1) It should be flexible enough to be stretched over the head and have a Velcro closure. It is also possible for it to be adhesive, magnetic, or lockable. Basic ultrasound imaging with ultrasonic patch (1) and probes (2) within the scope of the invention 20 In addition to these modes, it features electronic beam steering and dynamic focusing. (dynamic focusing), harmonic imaging, Doppler, elastography (shear wave), microvascular flow analysis (microfascicular flow imaging) and similar advanced imaging modes This will support AI-based automated targeting of the data generated by this hardware. It is possible to process it in a way that is suitable for recognition and serial tracking analysis. 25 It is possible that heat will be generated during the application of the probes (2) contained in the Patch (1). Temperature and leakage current control on patch (1) to prevent heat and voltage risks. This will ensure the patient's current safety against leakage current and contact current.
Claims
11 REQUESTS 1. Detection of nodules occurring in the thyroid gland, ultrasound examination of these nodules. visualization, classification, and tracking of changes over time for the purpose of examination and assessment of malignancy risks, 5 - a device that can be attached to / worn on the skin and obtains ultrasound data from the neck area. containing numerous probes (2) used to do, - for generating ultrasound waves and detecting the returning echoes Piezoelectric-based imaging of both nodules on the right and left. It is a multi-array system operating between 7 MHz and 15 MHz, preferably pMUT 10. probe (2) array and acoustic transmission between the skin can be established in a healthy way. with ultrasound gel and / or neck layers as a suitable coupling medium gel reservoir, hydrogel layer, microfluidic coupler to enhance contact a layer characterized by a coupling layer or a soft layer ultrasonic patch (1). 15 2. Wide frequencies of 18 MHz and above for situations requiring more detailed resolution. An ultrasonic probe as in Claim 1, characterized by probes (2) operated in the range. patch (1).
3. By generating a high electric field in the peak-to-peak voltage range of 10 V to 40 V. pMUT probe (2) elements with thin piezoelectric layers that enable operation 20 An ultrasonic patch (1) as in any of the claims 1-2, characterized by. At 4.7 MHz, the sensor's effective pulse duration is approximately 75 nanoseconds, and at 15 MHz... In working condition, the probe has an effective pulse duration of approximately 33 nanoseconds (2) like in any of the 1-3 claims characterized by its elements ultrasonic patch (1). 25