A wearable ultrasound device for detecting and modulating nerves and a method thereof

Abstract

A wearable ultrasound device for detecting and modulating nerves is disclosed The wearable ultrasound device includes a patch that is adhered on the skin of a patient. A printed circuit board placed within the patch is configured to receive an ultrasound image and is integrated with image processing to detect the position of the nerve. If the nerve is not found, a notification is sent to the healthcare provider to reapply the patch. The microcontroller verifies if parameters set by the healthcare provider in response to successful detection of the nerve. Variables corresponding to the position are obtained. A transceiver converts the variables to multi-channel analog echo signals and converts it from the phased transducer array to a digital echo signal. A phased transducer array is adapted to create ultrasound pulses resulting in an multi-channel analog echo signals and create ultrasound neuromodulation pulses thereby stimulating the nerve.

Description

[0001] A WEARABLE ULTRASOUND DEVICE FOR DETECTING AND MODULATING NERVES AND A METHOD THEREOF

[0002] EARLIEST PRIORITY DATE:

[0003] This Application claims priority from a Complete patent application filed in India having Patent Application No. 202441098345, filed on December 12, 2024, and titled “A WEARABLE ULTRASOUND DEVICE FOR DETECTING AND MODULATING NERVES AND A METHOD THEREOF”.

[0004] FIELD OF INVENTION

[0005] Embodiments of the present disclosure relate to the field of medical techniques and technologies, and more particularly to a wearable ultrasound device for detecting and modulating nerves and a method thereof.

[0006] BACKGROUND

[0007] For thousands of years, western medicine has utilized nerve stimulation as a therapeutic method. Historically, this was often achieved through methods like massaging, which aimed to relax patients and induce sleep.

[0008] Modem medicine has moved away from these traditional, manual methods toward more advanced and precise techniques. The current standard is the use of an invasive electrostimulation device implanted under the skin. This device uses electrical impulses to stimulate nerves, providing therapeutic benefits such as pain relief, treatment of neurological disorders, and improving certain physiological functions. However, this method is highly invasive and involves surgical implantation of devices, which include wires and a battery that needs to be replaced every few years. As a result, only a limited group of patients are eligible for such procedures.

[0009] Further, electrostimulation devices, often referred to as neurostimulators or neuromodulators, work by sending electrical signals to targeted nerves. Common examples include spinal cord stimulators and vagus nerve stimulators. They are implanted under the skin and can help control chronic pain or improve function in neurological disorders. This operation is very invasive leading to only a small group of patients being eligible for the procedure, which is worsened since both the wires as well as the battery have to be re-implanted every few years.

[0010] To address the limitations of implant-based methods, ultrasound nerve modulation has emerged as a non-invasive alternative. This technique uses focused ultrasound waves to stimulate nerves without the need for surgical implants, reducing the invasiveness and potential complications associated with traditional implant procedures.

[0011] Furthermore, ultrasound nerve modulation is a technology that uses focused ultrasound waves to achieve neuromodulation effects. Unlike implants, ultrasound can be targeted to specific nerve sites non-invasively, avoiding the need for surgery, reducing risks, and expanding the potential patient base for nerve modulation therapies. However, factors like tissue density, bone structure, and depth of the target nerve can affect the penetration and focus of ultrasound waves, leading to variability in treatment effectiveness between patients. Effective use of ultrasound nerve modulation requires specialized training to ensure correct targeting and application. Lack of expertise or improper use may reduce treatment efficacy or increase the risk of adverse effects.

[0012] Hence, there is a need for an improved system and method for detecting and modulating nerves which addresses the aforementioned issue(s).

[0013] OBJECTIVE OF THE INVENTION

[0014] An objective of the present invention is to provide a non-invasive and wearable neuromodulator that works by using ultrasound technology.

[0015] BRIEF DESCRIPTION

[0016] In accordance with an embodiment of the present disclosure, a wearable ultrasound device for detecting and modulating nerves is provided. The wearable ultrasound device includes a patch adapted to adhere to a predetermined area on the skin of a patient via an adhesive wherein the patch comprises a hydrogel cube in an enclosed tab wherein the hydrogel cube is adapted to concentrate waves to the skin. The wearable ultrasound device includes a printed circuit board placed within the patch. The printed circuit board includes an image processing unit configured to receive an ultrasound image from a microcontroller wherein the ultrasound image is integrated with the image processing to detect a position of one or more nerves within the predetermined area of the skin. The image processing unit is configured to obtain a plurality of variables corresponding to the position. The printed circuit board includes the microcontroller configured to receive the plurality of variables required for imaging sweep of a tissue surrounding the nerve. The microcontroller is configured to send a prompt to a healthcare provider to reapply the patch if the one or more nerves are not found. Further, the microcontroller is configured to verify one or more parameters set by the healthcare provider in response to successful detection of one or more nerves. The printed circuit board includes a transceiver connected between the microcontroller and the phased transducer array. The transceiver is configured to convert the plurality of variables to multi-channel analog echo signals. Further, the transceiver is configured to convert multi-channel analog echo signals from the phased transducer array to a digital echo signal. The printed circuit board includes a phased transducer array connected to the transceiver wherein the phased transducer array is configured to create ultrasound pulses resulting in an multi-channel analog echo signals. Further, the phased transducer array is configured create ultrasound neuromodulation pulses thereby stimulating the nerve for the said pre-defined time intervals set by the healthcare provider.

[0017] In accordance with another embodiment of the present disclosure, a method for detecting and modulating nerves by a wearable ultrasound device is provided. The method includes adhering, a patch via an adhesive, to a predetermined area on the skin of a patient. The method includes receiving, by an image processing unit of a printed circuit board, an ultrasound image from a microcontroller wherein the ultrasound image is integrated with image processing to detect a position of the one or more nerves within the predetermined area of the skin. The method includes obtaining, by an image processing unit of a printed circuit board, a plurality of variables corresponding to the position. The method includes receiving, by the microcontroller, the plurality of variables required for imaging sweep of a tissue surrounding the nerve and converting the plurality of variables into alpha angle, phi angle and focus depth. The method includes sending, by the microcontroller, a prompt to a healthcare provider to reapply the patch if the one or more nerves are not found. The method includes verifying, by the microcontroller, one or more parameters set by the healthcare provider in response to successful detection of the one or more nerves. The method includes converting, by a transceiver connected between the microcontroller and the phased transducer array, the plurality of variables to multi-channel analog echo signals. The method includes converting, by a transceiver connected between the microcontroller and the phased transducer array, multi-channel analog echo signals from the phased transducer array to a digital echo signal. The method includes creating, by a phased transducer array connected to the transceiver, ultrasound pulses resulting in an multi-channel analog echo signals. The method includes creating, by the phased transducer array connected to the transceiver, ultrasound neuromodulation pulses thereby stimulating the nerve for the said pre-defined time intervals set by the healthcare provider.

[0018] To further clarify the advantages and features of the present disclosure, a more particular description of the disclosure will follow by reference to specific embodiments thereof, which are illustrated in the appended figures. It is to be appreciated that these figures depict only typical embodiments of the disclosure and are therefore not to be considered limiting in scope. The disclosure will be described and explained with additional specificity and detail with the appended figures.

[0019] BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The disclosure will be described and explained with additional specificity and detail with the accompanying figures in which:

[0021] FIG. 1 is an exploded representation of a wearable ultrasound device for detecting and simulating nerves, in accordance with an embodiment of the present disclosure;

[0022] FIG. 2 is a schematic representation of a battery of FIG. 1, in accordance with an embodiment of the present disclosure;

[0023] FIG. 3 is a schematic representation of a cooling unit of FIG. 1, in accordance with an embodiment of the present disclosure;

[0024] FIG. 4a, FIG. 4b and FIG. 4c are schematic representations of a case of FIG. 1, in accordance with an embodiment of the present disclosure; FIG. 5 is a schematic representation of an ultrasound phased array of FIG. 1, in accordance with an embodiment of the present disclosure;

[0025] FIG. 6 is a schematic representation of a printed circuit board of FIG. 1, in accordance with an embodiment of the present disclosure;

[0026] FIG. 7a, FIG. 7b and FIG. 7c are schematic representations of a patch of FIG. 1, in accordance with an embodiment of the present disclosure;

[0027] FIG. 8 is a flow chart representing the steps involved by a healthcare specialist until neuromodulation is triggered, in accordance with an embodiment of the present disclosure;

[0028] FIG. 9 is a flow chart representing the steps involved in the neuromodulation procedure, in accordance with an embodiment of the present disclosure;

[0029] FIG. 10a illustrates a flow chart representing the steps involved in a method for detecting and simulating nerves by using a wearable ultrasound device in accordance with an embodiment of the present disclosure; and

[0030] FIG. 10b illustrates continued steps of the method of FIG. 10a in accordance with an embodiment of the present disclosure.

[0031] Further, those skilled in the art will appreciate that elements in the figures are illustrated for simplicity and may not have necessarily been drawn to scale. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the figures with details that will be readily apparent to those skilled in the art having the benefit of the description herein.

[0032] DETAILED DESCRIPTION

[0033] For the purpose of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiment illustrated in the figures and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Such alterations and further modifications in the illustrated system, and such further applications of the principles of the disclosure as would normally occur to those skilled in the art are to be construed as being within the scope of the present disclosure.

[0034] The terms “comprises”, “comprising”, or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such a process or method. Similarly, one or more devices or subsystems or elements or structures or components preceded by "comprises... a" does not, without more constraints, preclude the existence of other devices, sub-systems, elements, structures, components, additional devices, additional sub-systems, additional elements, additional structures or additional components. Appearances of the phrase "in an embodiment", "in another embodiment" and similar language throughout this specification may, but not necessarily do, all refer to the same embodiment.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs. The system, methods, and examples provided herein are only illustrative and not intended to be limiting.

[0036] In the following specification and the claims, reference will be made to a number of terms, which shall be defined to have the following meanings. The singular forms “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise.

[0037] In accordance with an embodiment of the present disclosure, a wearable ultrasound device for detecting and simulating nerves is provided. The wearable ultrasound device includes a patch adapted to adhere to a predetermined area on the skin of a patient. The wearable ultrasound device includes a printed circuit board (110) placed within the patch. The printed circuit board (110) includes an image processing unit configured to receive an ultrasound image from a microcontroller wherein the ultrasound image is integrated with the algorithm to detect a position of the one or more nerves within the predetermined area of the skin. The image processing unit is configured to obtain a plurality of variables corresponding to the position. The printed circuit board (110) includes the microcontroller configured to receive the plurality of variables required for imaging sweep of a tissue surrounding the nerve. The microcontroller is configured to send a prompt to a patient / healthcare provider to reapply the patch if the one or more nerves are not found. Further, the microcontroller is configured to verify one or more parameters set by the healthcare provider in response to successful detection of the one or more nerves. The printed circuit board includes a transceiver connected between the microcontroller and the phased transducer array. The transceiver is configured to convert the plurality of variables to multi-channel analog echo signals. Further, the transceiver is configured to convert multi-channel analog echo signals from the phased transducer array to a digital echo signal. The printed circuit board includes a phased transducer array connected to the transceiver wherein the phased transducer array. The phased transducer array is configured to create ultrasound pulses resulting in an multi-channel analog echo signals. Further, the phased transducer array is configured create ultrasound neuromodulation pulses thereby stimulating the nerve for the said pre-defined time intervals set by the healthcare provider.

[0038] FIG. 1 is an exploded representation of a wearable ultrasound device for detecting and simulating nerves, in accordance with an embodiment of the present disclosure. The wearable ultrasound device (100) includes a wearable and autonomous patch (105) that is placed / adhered on a predetermined area on the skin of a patient via micro needles or an adhesive. The patch (105) includes a hydrogel cube in an enclosed tab wherein the hydrogel cube is adapted to concentrate waves to the skin. Typically, the hydrogel cube typically refers to a small, three-dimensional cube made from a hydrogel material. In one embodiment, the patch (105) is flexible and is adapted with a locking mechanism (140) to ensure secure fit. In one embodiment, the locking mechanism (140) is a groove-based snap-and-fit locking mechanism. The patient is an individual who is undergoing a medical evaluation or treatment, particularly for conditions that require nerve detection and stimulation. The patient could be any person someone experiencing nerve-related issues, undergoing rehabilitation, or needing diagnostic monitoring through the wearable ultrasound device. Essentially, the patient is the end-user for whom the device is intended to provide medical or therapeutic benefit. Further, the patch (105) is applied to a "predetermined area," meaning a specific location chosen based on the area where nerve detection or stimulation is needed. The predetermined area is typically selected based on clinical requirement, a specific nerve or region of interest. Examples of the predetermined area includes, but is not limited to the following:

[0039] 1. Wrist or Forearm: To detect or stimulate the median nerve or ulnar nerve for conditions like carpal tunnel syndrome or ulnar neuropathy.

[0040] 2. Neck: To detect or stimulate the vagus nerve for therapies related to epilepsy, depression, or to manage inflammation.

[0041] 3. Lower Back: To detect or stimulate nerves in the lumbar region, such as for managing lower back pain or sciatica.

[0042] 4. Knee or Thigh: To monitor or stimulate the sciatic nerve or femoral nerve, potentially for pain management or recovery after knee surgery.

[0043] 5. Upper Arm or Shoulder: To focus on the brachial plexus or other nerves in the arm, often useful for rehabilitation after a stroke or nerve injury.

[0044] 6. Foot or Ankle: For conditions like diabetic neuropathy, the device could be placed over the tibial nerve or peroneal nerve to monitor nerve function or provide stimulation.

[0045] Further, the wearable ultrasound device (100) includes a printed circuit board (110) (PCB) placed within the patch (105). The PCB (110) is a flat board that contains electrical components and circuitry necessary for the device to function. In one embodiment, the printed circuit board (110) includes a USB-c connector (not shown in FIG. 1). In one embodiment, the printed circuit board (110) may include other USB types, as well as proprietary and legacy connectors.

[0046] The printed circuit board (110) includes an image processing unit image processing unit configured to receive an ultrasound image from a microcontroller (125). The image processing unit is configured to perform the task of identifying nerves within the body using ultrasound imaging. The ultrasound image is integrated with image processing to detect a position of the one or more nerves within the predetermined area of the skin. The ultrasound images are processed using a neural network, which is a type of an artificial intelligence (Al) model. The neural network helps to analyse the image to accurately detect the position of one or more nerves within the predetermined area on the skin. This integration allows the device to perform complex image recognition and analysis tasks automatically and in real-time. Additionally, the image processing unit is configured to obtain a plurality of variables corresponding to the position. The plurality of variables include the depth of the nerve, its size, shape, orientation, or other characteristics that are important for diagnostics or treatment.

[0047] The microcontroller (125) is operatively coupled to the image processing unit wherein the microcontroller (125) is configured to receive the plurality of variables required for imaging sweep of a tissue surrounding the nerve. In one embodiment, the microcontroller (125) may not receive the plurality of variables for each image sweep. The microcontroller (125) scans the area of the skin to monitor the position of the one or more nerves. The plurality of variables received by the microcontroller (125) includes the depth of the tissue being scanned, the angle or direction of the ultrasound waves, the speed of the ultrasound waves and adjustments required for different tissue densities. Typically, the imaging sweep involves scanning a broad area to create a comprehensive image, helping to identify and map out the exact location of nerves The microcontroller (125) is also configured to send a prompt to a healthcare provider (or a user) to reapply the patch (105) if the one or more nerves are not found. This prompt could be a visual or auditory alert indicating that the patch (105) is not correctly positioned or adhered, and it needs to be reapplied to a different location or adjusted on the patient's skin. This process repeats until the exact nerve is found. Additionally, the microcontroller (125) is configured to verify one or more parameters set by the healthcare provider in response to successful detection of the one or more nerves. The one or more parameters includes the specific nerves that need to be detected, the desired scanning area or range, sensitivity settings for nerve detection and thresholds for a successful detection of the one or more nerves. The microcontroller (125) ensures that these parameters are met and maintained during the detection process.

[0048] Further, the microcontroller (125) connects to the user device (not shown) via Wi-Fi or Bluetooth connections.

[0049] In one embodiment, the microcontroller (125) connects to a user device operated by the healthcare provider to allow the healthcare provider to set the one or more parameters for simulation of the one or more nerves. Examples of the one or more parameters includes, but is not limited to, time and frequency. Examples of the user device includes, but is not limited to, a mobile phone, desktop computer, portable digital assistant (PDA), smart phone, tablet, ultra-book, netbook, laptop, multiprocessor system, microprocessor-based or programmable consumer electronic system, or any other communication device that a user may use.

[0050] The PCB (110) includes a transceiver connected between the microcontroller (125) and the phased transducer array (135). The transceiver (130) is an electronic component placed on the PCB (110) of the wearable ultrasound device. The transceiver (130) is designed to both transmit and receive signals. It acts as an interface between the microcontroller (125) (which processes data and controls the device) and the phased transducer array (which emits and receives ultrasound waves) (135).

[0051] The transceiver (130) is configured to convert the plurality of variables to multichannel analog echo signals (also referred as electronic pulse signals). This involves obtaining the variables (such as parameters for imaging, like frequency, phase, and amplitude) provided by the microcontroller (125) and translating them into electrical signals that can be sent to each individual element of the phased transducer array (135).

[0052] Additionally, the transceiver (130) is configured to convert multi-channel analog echo signals from the phased transducer array (135) to a digital echo signal. Typically, multi-channel analog echo signals refers to signals with different delays sent to each transducer element, enabling the phased transducer array (135) to emit ultrasound waves in a coordinated manner, which allows for precise focusing and steering of the ultrasound beam. When the phased transducer array (135) emits ultrasound waves, these waves bounce off tissues and structures within the body and return as echo signals. These returned signals are initially multi-channel analog signals because they are captured by the individual elements of the transducer array (135) in analog form. The transceiver (130) converts these multi-channel analog echo signals into digital signals. This involves converting the continuous analog signals into a digital format (discrete values that can be processed by the microcontroller (125)).

[0053] Further, the PCB (110) includes a phased transducer array (135) connected to the transceiver (130). This connection allows the transceiver (130) to control and coordinate the ultrasound pulses emitted by the phased transducer array (135). The phased transducer array (135) is made up of multiple small transducer elements that can be individually controlled. In other words, each of the multiple small transducer elements have different material properties resulting in different resonance frequencies. In a specific embodiment, the phased transducer array (135) includes three different sub array corresponding to a low frequency resonance frequency for ultrasound neuromodulation, a middle frequency for imaging and a high frequency for perfusion. The phased transducer array (135) is configured to create ultrasound pulses resulting in an multi-channel analog echo signals. The pulses are emitted into the body, and as they encounter different tissues, they are reflected back to the phased transducer array (135). The returning echoes are captured by the array's multiple elements, generating multi-channel analog echo signals. Each element of the array captures a portion of the reflected sound waves, resulting in multiple analog signals that represent the echoes from various directions and depths within the body. The transceiver (130) then converts these analog signals into digital signals, allowing the microcontroller (125) to process them and create detailed ultrasound images.

[0054] Additionally, the phased transducer array (135) is configured to create ultrasound neuromodulation pulses thereby stimulating the nerve for the said pre-defined time intervals set by the healthcare provider. Typically, the neuromodulation pulses are specific types of ultrasound waves designed to stimulate nerves rather than just create images. By focusing these neuromodulation pulses at a particular nerve or region of interest, the nerve activity can be modified or influenced. This can be useful for therapeutic purposes, such as pain management, nerve rehabilitation, or treatment of certain neurological conditions. Further, the stimulation is performed for pre-defined time intervals that are set by the healthcare provider. This allows for precise control over the duration and intensity of the nerve stimulation, ensuring it is tailored to the patient's specific therapeutic needs.

[0055] Furthermore, the phased transducer array (135) is configured to perform perfusion measurements and ultrasound thermometry. Perfusion refers to the flow of blood through tissues or organs. Measuring perfusion is essential for understanding the oxygen and nutrient supply to tissues, especially in organs like the heart, brain, and kidneys. It’s also important in monitoring tissue health, healing after surgery, and assessing areas affected by diseases like cancer or stroke. Ultrasound thermometry is the measurement of tissue temperature using ultrasound. It is particularly valuable in procedures where controlled heating of tissue is involved, such as thermal ablation (using heat to destroy cancer cells) and neuromodulation.

[0056] In one embodiment, the wearable ultrasound device (100) includes a cooling unit (150) fabricated with a conductive material to evenly distribute heat across a surface. Further, the wearable ultrasound device (100) includes a battery (160) adapted to be charged by the microcontroller (125) via a power source. The battery (160) is rechargeable via a USB-C interface. In one embodiment, the battery (160) is a rechargeable Li-Po battery.

[0057] In one embodiment, the wearable ultrasound device (100) includes a case (165) adapted to enclose the battery (160), cooling unit (150), ultrasound phased transducer array (135) and printed circuit board (110) wherein the case (165) is watertight and lined from inside with a padding material. The case (165) is attached to the patch (105). In such an embodiment, the case (165) includes a slot for charging the wearable ultrasound device (100). Further, the case (165) includes the USB-C is present on the case (165).

[0058] Consider a non-limiting example of a patient ‘X’ . As a pre-requisite, a healthcare provider attending to the requirements of the patient ‘X’, programs the wearable ultrasound device (100) by assigning a desired time and frequency for the neurostimulation via a user device. The wearable ultrasound device (100) is turned ‘ON’ and adhered to the skin of the patient ‘X’ on his / her neck region to target the vagus nerve. Subsequently, the wearable ultrasound device (100) makes a scan to monitor the position of the nerve by the ASIC. If the nerve is not found, the healthcare provider is notified via a feedback sent by the microcontroller (125) or from the user device. This notification prompts the healthcare provider to reapply the wearable ultrasound device (100). In other words, the healthcare provider is notified to change the position of the patch (105). This is repeated until the nerve is found. At this point, the microcontroller (125) verifies if the required parameters set by the healthcare provider are correct. Now, the neuromodulation is performed and is completely controlled by the microcontroller (125). The microcontroller (125) will contain the variables (Angles, focus depth, pitch) needed for a complete imaging sweep of the tissue surrounding the vagus nerve. This information will be sent via I / O ports towards the transceiver (130), where it will be converted into shifted pulses. These shifted pulses are used to drive the phased ultrasound transducer array (135) where it will be converted towards ultrasound waves. The echoes from these ultrasound waves will be converted by the transceiver (130) into a digital signal. The microcontroller (125) will receive these echo signals and convert them into a complete image. In one embodiment, the object detection unit (115) may also be configured to receive these echo signals and convert them into a complete image. This complete image will be sent through electronic circuitry to the object detection unit (115) or ASIC, or via a wireless connection towards a GPU within the user device. The image sent towards the object detection ASIC / GPU will be put through a neural network, resulting in the position of the nerve with a degree of certainty. Once calculated, the position will be sent towards the microcontroller (125) which will calculate the angles and focus depth which then again will be sent towards the transceiver (130) in order to neuromodulation.

[0059] FIG. 2 is a schematic representation of a battery of FIG. 1, in accordance with an embodiment of the present disclosure. In one embodiment, the battery (160) is a standard rechargeable Li-Po battery that can be recharged via a USB-C interface. The slot for the USB-C is on the case (165). The battery (160) includes negative and positive terminals.

[0060] FIG. 3 is a schematic representation of a cooling unit of FIG. 1, in accordance with an embodiment of the present disclosure. The cooling unit (150) utilizes a passive cooling technique with a metal plate to transfer the heat to the surface of the wearable ultrasound device (100). The cooling unit (150) includes a plurality of fins (155) positioned on the metal plate that is used to dissipate the heat.

[0061] FIG. 4a, FIG. 4b and FIG. 4c are schematic representations of a case of FIG. 1, in accordance with an embodiment of the present disclosure. The case (165) encompasses the battery (160), cooling unit (150), ultrasound phased transducer array (135) and printed circuit board (110). The case (165) also includes a hallow cavity in the bottom region to allow the ultrasound phased array (135) to emit ultrasound without disruption. The PCB (110) and the case (165) are glued watertight wherein the PCB (110) touches the edges of the square hole.

[0062] The case (165) also includes a female end of the locking mechanism (140).

[0063] FIG. 5 is a schematic representation of an ultrasound phased array of FIG. 1, in accordance with an embodiment of the present disclosure. The ultrasound phased array (135) produces both imaging pulses and neuromodulation pulses for modulation with n-number of elements. Each element within the phased array (135) consists of top to bottom - a matching layer, a piezo material, and a backing material. All of these elements are placed on top of a flexible PCB (110) in order to maximise contact with the skin. The distance between the centre of each element next to each other, referred to as the pitch, is twice the wavelength of the produced ultrasound wave in order to protect from distortion referred to as grating lobes. In order to compensate for the natural curvature of the patient's body using the ultrasound patch (105) the distance between the edges of the elements is widened.

[0064] FIG. 6 is a schematic representation of a printed circuit board of FIG. 1, in accordance with an embodiment of the present disclosure. The PCB (110) includes the image processing unit (115), ultrasound transceiver (130) and the microcontroller (125). The image processing unit (115) receives an ultrasound image as an input and outputs the position of the selected nerves within the ultrasound image. This is done by using Neural Network (NN) configured with the image processing unit (115). The Neural Network is trained to recognize patterns specific to nerves within these images. By learning from a dataset of labelled ultrasound images, the NN can detect subtle features and differentiate nerves from surrounding tissues. Further, the ultrasound transceiver (130) is connected between a microcontroller (125) and a 2D phased array transducer (135).

[0065] The microcontroller (125) is also connected to the user device via a wireless connection (for instance, Bluetooth or Wi-Fi) for further user functionality / feedback and allowing a healthcare official to program neuromodulation parameters such as time and frequency. The microcontroller (125) is configured to send a bitstream in order to send delay data towards the transceiver (130) and the input data required for creating an ultrasound beam. Similarly, the microcontroller (125) receives digital ultrasound echo signals and saves it within its internal memory. These signals are sent either wirelessly towards a GPU on the user device or towards the image processing unit (115). In both of these cases the microcontroller (125) receives the position of the requested nerve and in turn will convert the position into an alpha angle, phi angle and focus depth.

[0066] FIG. 7a, FIG. 7b and FIG. 7c are schematic representations of a patch (105) of FIG. 1, in accordance with an embodiment of the present disclosure. The patch (105) includes the male end of the locking mechanism (140). This allows the case (165) to be safely removed in scenarios where the patch (105) is damaged and hence does not adhere to the skin correctly. The patch (105) adheres to the skin via microneedles (145) thereby allowing it to be reusable. The patch (105) consists of a set of male connectors to attach to the skin.

[0067] FIG. 8 is a flow chart representing the steps involved by a healthcare specialist until neuromodulation is triggered, in accordance with an embodiment of the present disclosure. The patch must be programmed before use via the healthcare specialist by setting the frequency and time of the neurostimulation at step (805). The patch is turned ‘ON’ and attached to the patient’s skin at step (810). At this point of time, the patch performs a short scan to monitor the position of the nerve using the ASIC at step (815). If the nerve is not found, the patient will be prompted by a feedback from the microcontroller or from a user device to change the position of the patch. If the nerve is found, the parameters (frequency and time) set by the healthcare specialist is verified at step (820). Finally, the neuromodulation procedure begins at step (825).

[0068] FIG. 9 is a flow chart representing the steps involved in the neuromodulation procedure, in accordance with an embodiment of the present disclosure. Once the frequency and time is set-up as discussed in FIG. 8, the neuromodulation procedure begins. The microcontroller (905) verifies if the nerve is found at step (925). If the nerve is not found, then a feedback is sent to the user to reapply the patch at step (930). The microcontroller (905) then retrieves delays for imaging at step (935) and transmits to the transceiver (910). The transceiver (910) converts the variables to multi-channel signals at step (940) and transmits to the ultrasound phased transducer array (920). The ultrasound phased transducer array (920) creates ultrasound pulses resulting in echo analog signals at step (945) and transmits it to the transceiver (910). The transceiver (910) converts the multi-channel analog echo signals to digital echo signals at step (950) and transmits to the microcontroller (905). The microcontroller (905) combines all the incoming digital echo signals into an ultrasound image in step (955) and transmits to ASIC. The ASIC returns the coordinates of the nerve to the microcontroller for further verification at step (960).

[0069] Alternatively, if the nerve is found at step (925), then the microcontroller (905) calculates angles and focalspot depth based on coordinates at step (965). These values are sent to the transceiver (910) which converts the variables to multi-channel signals at step (970). These signals are transmitted to the ultrasound phased transducer array which finally creates the ultrasound neuromodulation pulses at step (975).

[0070] FIG. 10a illustrates a flow chart representing the steps involved in a method (300) for detecting and simulating nerves by using a wearable ultrasound device in accordance with an embodiment of the present disclosure. FIG. 10b illustrates continued steps of the method (300) of FIG. 10a in accordance with an embodiment of the present disclosure. The method (300) includes adhering, a patch, to a predetermined area on the skin of a patient in step (305). In one embodiment, the patch is flexible and is adapted with a locking mechanism (140) to ensure secure fit.

[0071] The method (300) includes receiving, by an image processing unit of a printed circuit board, an ultrasound image from a microcontroller wherein the ultrasound image is integrated with image processing to detect a position of the one or more nerves within the predetermined area of the skin in step (310).

[0072] In one embodiment, the microcontroller connects to a user device operated by the healthcare provider to allow the healthcare provider to set the one or more parameters for simulation of the one or more nerves, wherein the one or more parameters comprises time and frequency.

[0073] The method (300) includes obtaining, by an image processing unit of a printed circuit board, a plurality of variables corresponding to the position in step (315).

[0074] The method (300) includes receiving, by the microcontroller, the plurality of variables required for imaging sweep of a tissue surrounding the nerve and converting the plurality of variables into alpha angle, phi angle and focus depth in step (320). In one embodiment, the microcontroller scans the area of the skin to monitor the position of the one or more nerves. The microcontroller uses the plurality of variables to scan the area. Ultrasound waves are emitted at the angles and depth specified by the alpha and phi angles and focus depth. Consequently, the position of one or more nerves is continuously monitored by analysing the returned echo signals.

[0075] The microcontroller receives the plurality of variables necessary for conducting an imaging sweep of the tissue around the nerve. These variables could include data such as tissue density, expected nerve location, or imaging parameters. These variables help configure the ultrasound device to perform an effective scan.

[0076] Subsequently, the plurality of variables are converted into three specific parameters namely, alpha angle, phi angle and focus depth. By converting the received variables into these parameters, the microcontroller optimizes the ultrasound device to scan the tissue effectively, considering the angles and depth required for accurate nerve detection. Specifically, the alpha angle represents the tilt or orientation of the ultrasound beam with respect to the surface of the skin. Adjusting the alpha angle allows the ultrasound waves to penetrate the tissue at different angles, which helps in acquiring a clearer and more detailed image of the nerve structures. Likewise, the phi angle refers to another dimension of rotation or steering of the ultrasound beam. It allows for further directional control of the beam in a different plane, enabling a three- dimensional scan of the targeted area. Further, the focus depth is a parameter that defines the depth at which the ultrasound beam is focused. It ensures that the ultrasound energy is concentrated at the appropriate depth within the tissue.

[0077] The method (300) includes sending, by the microcontroller, a prompt to a healthcare provider to reapply the patch if the one or more nerves are not found in step (325). The prompt is triggered if the one or more nerves is not detected within the area of the skin being scanned. This failure could occur for several reasons, such as, but not limited to,

[0078] 1. The patch is not correctly positioned over the area where the nerves are located.

[0079] 2. Insufficient contact between the patch and the skin, leading to poor ultrasound wave transmission.

[0080] 3. The nerve is outside the current imaging range or scanning parameters.

[0081] 4. Technical issues, such as a low-quality signal or interference. The prompt therefore informs the healthcare provider that the patch needs to be reapplied or repositioned.

[0082] The method (300) includes verifying, by the microcontroller, one or more parameters set by the healthcare provider in response to successful detection of the one or more nerves in step (330). The one or more parameters refers to the time and frequency of the simulation to be applied.

[0083] The method (300) includes converting, by a transceiver connected between the microcontroller and the phased transducer array, the plurality of variables to multichannel signals in step (335). The transceiver takes these variables and translates them into multi-channel electrical signals. This means that it creates separate electrical signals for each of the individual elements within the phased transducer array. By doing so, the transceiver controls the precise timing, frequency, and amplitude of the ultrasound pulses emitted by each element. The multi-channel signals allow the phased transducer array to steer and focus the ultrasound beam in different directions and at different depths.

[0084] The method (300) includes converting, by a transceiver connected between the microcontroller and the phased transducer array, multi-channel analog echo signals from the phased transducer array to a digital echo signal in step (340). After the phased transducer array emits ultrasound pulses into the body, these pulses travel through the tissue and are reflected back as echoes when they encounter the one or more nerves. In other words, the analog signals are converted to digital signals.

[0085] The method (300) includes creating, by a phased transducer array connected to the transceiver, ultrasound pulses resulting in an multi-channel analog echo signals in step (345). Each element of the phased transducer array receives these returning echoes and converts them into analog electrical signals. Since each element may receive the echoes at slightly different times and intensities, the result is a set of multi-channel analog echo signals. These signals are the raw data needed to create an ultrasound image or detect the presence and position of nerves within the tissue. By capturing multiple signals from different elements, a comprehensive, high-resolution image is generated, allowing for accurate detection and monitoring of nerves. The term "multi-channel" indicates that there are multiple signals corresponding to each element of the array, each providing a slightly different view or perspective of the scanned area.

[0086] The method (300) includes creating, by the phased transducer array connected to the transceiver, ultrasound neuromodulation pulses thereby stimulating the nerve for the said pre-defined time intervals set by the healthcare provider in step (350). Ultrasound neuromodulation pulses are specialized ultrasound pulses designed to interact with nerves in a way that either stimulates or inhibits their activity. The ultrasound energy can modulate (adjust) the nerve's function, potentially altering pain signals, improving nerve function, or treating various neurological conditions. The ultrasound energy is focused on specific nerves by adjusting the phase and amplitude of the pulses, ensuring that the targeted nerve receives the appropriate amount of stimulation.

[0087] Various embodiments of the present disclosure provides a wearable ultrasound device for detecting and simulating nerves with several benefits. The wearable ultrasound device can be simply applied by the patient, turned on and the designated nerve will be stimulated at pre-programmed intervals set by a healthcare provider. Further, the wearable ultrasound device provides a non-invasive alternative, broadening eligibility and minimizing potential complications. Additionally, the wearable ultrasound device utilizes the neuromodulation parameters that enhances targeting and can be customized to meet patient-specific needs.

[0088] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the disclosure and are not intended to be restrictive thereof.

[0089] While specific language has been used to describe the disclosure, any limitations arising on account of the same are not intended. As would be apparent to a person skilled in the art, various working modifications may be made to the method in order to implement the inventive concept as taught herein.

[0090] The figures and the foregoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment. For example, the order of processes described herein may be changed and are not limited to the manner described herein. Moreover, the actions of any flow diagram need not be implemented in the order shown; nor do all of the acts need to be necessarily performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts. The scope of embodiments is by no means limited by these specific examples.

Claims

I CLAIM:

1. A wearable ultrasound device (100) for detecting and simulating nerves comprising: characterized in that, a patch (105) adapted to adhere to a predetermined area on the skin of a patient via an adhesive wherein the patch (105) comprises a hydrogel cube in an enclosed tab wherein the hydrogel cube is adapted to concentrate waves to the skin; a printed circuit board (110) placed within the patch (105) comprising: an image processing unit (115) configured to: receive an ultrasound image from a microcontroller (125) wherein the ultrasound image is integrated with image processing to detect a position of the one or more nerves within the predetermined area of the skin; and obtain a plurality of variables corresponding to the position; the microcontroller (125) operatively coupled to the image processing unit (115), wherein the microcontroller (125) is configured to: receive the plurality of variables required for imaging sweep of a tissue surrounding the nerve and convert the plurality of variables into alpha angle, phi angle and focus depth; send a prompt to a healthcare provider to reapply the patch if the one or more nerves are not found; verify one or more parameters set by the healthcare provider in response to successful detection of the one or more nerves; an transceiver (130) connected between the microcontroller (125) and a phased transducer array (135) wherein the transceiver (130) is configured to: convert the plurality of variables to multi-channel analog echo signals; and convert multi-channel analog echo signals from the phased transducer array (135) to a digital echo signal; the phased transducer array (135) connected to the transceiver (130) wherein the phased transducer array (135) is configured to:create ultrasound pulses resulting in an multi-channel analog echo signals; and create ultrasound neuromodulation pulses thereby stimulating the nerve for the said pre-defined time intervals set by the healthcare provider.

2. The wearable ultrasound device (100) as claimed in claim 1, wherein the patch (105) is flexible and is adapted with a locking mechanism (140) to ensure secure fit and wherein the patch comprises a plurality of microneedles (145) to adhere to the skin of the patient.

3. The wearable ultrasound device (100) as claimed in claim 1, wherein the printed circuit board (110) comprises a USB-c connector.

4. The wearable ultrasound device (100) as claimed in claim 1, comprising: a cooling unit (150) fabricated with a conductive material to evenly distribute heat across a surface via a plurality of fins (155); and a battery (160) adapted to be charged by the microcontroller (125) via a power source.

5. The wearable ultrasound device (100) as claimed in claim 1, comprising a case (165) adapted to enclose the battery (160), cooling unit (150), phased transducer array (135) and printed circuit board (110) wherein the case (165) is watertight and lined from inside with a padding material.

6. The wearable ultrasound device (100) as claimed in claim 5, wherein the case (165) comprises a slot for charging.

7. The wearable ultrasound device (100) as claimed in claim 1, comprising a lens adapted to act as a medium for focusing ultrasound waves onto the skin.

8. The wearable ultrasound device (100) as claimed in claim 1, wherein the microcontroller (125) connects to a user device operated by the healthcare provider to allow the healthcare provider to set the one or more parameters for simulation of theone or more nerves, wherein the one or more parameters comprises time and frequency.

9. The wearable ultrasound device (100) as claimed in claim 1, wherein the microcontroller (125) scans the area of the skin to monitor the position of the one or more nerves.

10. A method (300) for detecting and simulating nerves comprising: adhering, a patch, to a predetermined area on the skin of a patient; (305) receiving, by an image processing unit of a printed circuit board, an ultrasound image from a microcontroller wherein the ultrasound image is integrated with image processing to detect a position of the one or more nerves within the predetermined area of the skin; (310) obtaining, by an image processing unit of a printed circuit board, a plurality of variables corresponding to the position; (315) receiving, by the microcontroller, the plurality of variables required for imaging sweep of a tissue surrounding the nerve and converting the plurality of variables into alpha angle, phi angle and focus depth; (320) sending, by the microcontroller, a prompt to a healthcare provider to reapply the patch if the one or more nerves are not found; (325) verifying, by the microcontroller, one or more parameters set by the healthcare provider in response to successful detection of the one or more nerves; (330) converting, by a transceiver connected between the microcontroller and the phased transducer array, the plurality of variables to multi-channel analog echo signals; (335) converting, by a transceiver connected between the microcontroller and the phased transducer array, multi-channel analog echo signals from the phased transducer array to a digital echo signal; (340) creating, by a phased transducer array connected to the transceiver, ultrasound pulses resulting in an multi-channel analog echo signals; (345) andcreating, by the phased transducer array connected to the transceiver, ultrasound neuromodulation pulses thereby stimulating the nerve for the said predefined time intervals set by the healthcare provider. (350)

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