WO2025120570A1

WO2025120570A1 - Handheld vascular doppler system

Info

Publication number: WO2025120570A1
Application number: PCT/IB2024/062271
Authority: WO
Inventors: Adi Ovadia YOSSEF
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-12-07
Filing date: 2024-12-05
Publication date: 2025-06-12
Anticipated expiration: 2026-06-07

Abstract

A handheld vascular Doppler device, comprising: an ultrasonic probe configured for generating ultrasonic raw data; a universal serial bus (USB); the USB comprises a plurality of channels; and a control circuit, the control circuit comprises a communication module and is configured for 5 segmenting the ultrasonic raw data into a plurality of data packets and for associating the plurality of data packets with the plurality of channels; wherein the USB is configured for transmitting the plurality of data packets via the plurality of Human Interface Device (HID) channels to a mobile computing device; the transmitting is for processing the ultrasonic raw data by the mobile computing device and for presenting the processed data to a user.

Description

HANDHELD VASCULAR DOPPLER SYSTEM

FIELD OF THE INVENTION

The present disclosure relates to medical diagnostic apparatuses in general, and to vascular Doppler system, in particular.

BACKGROUND OF THE INVENTION

Vascular Doppler ultrasound is employed for non-invasive assessments of vascular conditions. These Vascular Doppler ultrasound utilize high-frequency sound waves to detect and evaluate blood flow in arteries and veins, typically used for assessing peripheral vascular conditions.

Handheld Vascular Doppler ultrasound are inherently simple in their construct, typically equipped to output Doppler audio through built-in speakers and predominantly battery-operated for enhanced portability. A wide variance exists in their display features, ranging from models devoid of any display to those with 7-segment displays, and some equipped with elementary waveform displays, especially in zero-crossing Doppler modules.

SUMMARY OF THE INVENTION

The term mobile computing device refers herein to a device that includes a processing unit such as a tablet or a cellular device and an Android or iOS operating system.

The term module refers herein to a software module or a hardware module. The software module may be an application.

The subject matter discloses a handheld vascular Doppler system designed for non-invasive testing of blood flow in the peripheral vasculature.

According to some embodiments, a handheld vascular Doppler system includes a handheld vascular Doppler unit connected to an ultrasound pen Doppler probe and is capable of emitting and receiving ultrasonic waves via a piezoceramic crystal attached to the tip of the probe. An integrated electronic circuit within the handheld vascular Doppler unit calculates the Doppler shift and outputs it into integrated speakers.

According to some embodiments, the handheld vascular Doppler unit is in connectivity with a mobile computing device that analyzes data received from the handheld vascular Doppler and presents the results of the analysis.

According to some embodiments, the system includes a module installable on the mobile computing device. The module is configured for analyzing the raw Doppler shift data received from the handheld vascular Doppler unit and for presenting results. Such results may be, for example, a color-coded Doppler spectrum and an algorithm performed on the generated color- coded Doppler spectrum to calculate parameters and indices. Upon receiving the raw Doppler shift data from the ultrasound probe, the module processes this data through a series of digital signal processing steps. Initially, the module applies a high-pass filter to remove low-frequency noise and other undesired signals, isolating the true blood flow signal. Subsequently, the filtered signal is subjected to Fast Fourier Transform (FFT) algorithms, which decompose the Doppler audio signals into a spectrum of velocities, translating the acoustic data into a visual spectral display. In some embodiments, the module enhances the user experience by allowing the selection of the visual representation of the FFT output from a predefined list of color palettes. The module is configured to work on various operating systems, such as Android and iOS platforms, and may control the handheld vascular Doppler or the electronic inflation device, or a combination thereof.

In some embodiments, the handheld vascular Doppler unit includes physical buttons designed to function as a remote control for the module and/or for controlling the handheld vascular Doppler unit. The integration of physical buttons is adapted to remotely control the mobile computing device to simplify user interaction and offer the user a more efficient and intuitive method of operating the system when connected to the mobile computing device. The buttons enable, for example, quick adjustments of software settings, switching modes and data capture, without diverting attention from the patient. In some embodiments, the physical buttons include advanced functionalities, such as starting or stopping measurements, vessel label switching within the active protocol, and direct report printing or reviewing. In some embodiments, the handheld vascular Doppler unit includes an electronic inflation device, equipped with an electric air pump, an electronic controlled valve and an electronic pressure sensor. The pneumatic components are controlled by an electronic circuit and via a processing unit such as a microcontroller. The pneumatic components are connected internally via an air tube. The internal air tube is connected to an external air tube that can be connected to a pressure cuff. Such an electronic inflation device replaces a manual inflation pump. In some embodiments, the electronic inflation device includes a port for a Photoplethysmograph (PPG) sensor that connects to a PPG sensor. The PPG sensor is an infrared-based sensor that is attached to the skin surface and measures local blood perfusion. In some embodiments, the electronic inflation device is connected to the mobile computing device for transferring data, such as an electronic pressure sensor reading and a PPG curve for processing and display. In some embodiments, the electronic inflation device can be physically attached to the mobile computing unit in various ways, including mechanical attachments, Velcro or similar adhesive materials, or even housed within a dedicated bag or pouch.

In some embodiments, the mobile computing device controls the underlying functionalities of the handheld vascular Doppler system, or the electronic inflation device, or the devices combination.

In some embodiments, the module that is embedded or installed in the mobile computing device uses the processed spectrum of the Doppler shift frequencies as input for generating and for displaying an envelope curve. The envelope curve is the peak velocity of blood flow within the peripheral vasculature over time. The analysis effectively captures the physiological blood flow dynamics during the cardiac cycle. In some embodiments, the module on the mobile computing device provides direct printing of the final examination report. This functionality allows healthcare professionals to generate physical copies of the Doppler analysis immediately after the conclusion of the examination is performed via the mobile computing device. The printing capability is designed to be versatile, supporting various connectivity options, including wireless networking protocols and Bluetooth, as well as the option for a direct physical connection to the printer. This printing facilitates the rapid dissemination of hard-copy reports within the clinical workflow.

According to some embodiments, the handheld vascular Doppler unit and the mobile device are mechanically attached by, for example, a locking mechanism that allows the mobile device to be securely fastened to the handheld Doppler. The locking mechanism may be, for example, a clip-on attachment or a sliding dock on the Doppler unit, where the mobile device snaps into place and is held securely during use. The mechanical connection may be designed to be strong enough to prevent accidental detachment while allowing for easy release when necessary. Such a mechanism ensures that the mobile device remains attached even during active patient assessments, providing a stable platform for viewing and interacting with the Doppler data.

According to some other embodiments, the handheld vascular Doppler unit and the mobile device are attached by use of Velcro or a similar adhesive material. Such an attachment method provides a less permanent but still secure attachment, allowing for quick removal and reattachment of the device as needed. The Velcro strips could be strategically placed on the back of the Doppler and the corresponding side of the mobile device, offering a flexible yet firm bond between the two.

According to some other embodiments, the handheld vascular Doppler unit and the mobile device are placed in a dedicated bag. The bag, may be made of a durable and cleanable material like ballistic nylon, and may be designed to hold the handheld Doppler on one side, with custom cut-outs aligning with the Doppler probe's connector, USB connectors, speakers, and controls for unimpeded access. On the reverse side, the mobile device is attached, also with specific openings for essential functions such as the charging port and touchscreen access. This bag not only protects the devices but also integrates them into a single unit that can be easily transported and handled within various clinical environments.

Attaching the handheld vascular Doppler unit to the mobile device provides the flexibility to suit different clinical needs and preferences, ensuring that the handheld Doppler and mobile device can function as a cohesive, user-friendly diagnostic tool. The attachment mechanisms enhance the device's portability and ease of use while ensuring that important functionalities, such as charging, audio output, and data interaction, remain accessible at all times.

[0001] One technical problem dealt with by the present disclosure is how to enhance the functionality of the handheld vascular Doppler unit. Despite the advancements in Doppler technology, traditional handheld vascular Doppler devices are largely confined to their original, basic designs, unable to display or utilize a color-coded Doppler spectrum.

One technical solution is a handheld vascular Doppler device; comprising: an ultrasonic pen Doppler probe configured for transmitting and receiving ultrasonic signals; a universal serial bus (USB) interface; the USB interface comprises a plurality of Human Interface Device (HID) channels; and a control circuit, the control circuit is configured for processing the ultrasonic signals to generate ultrasonic Doppler shift raw data; the control circuit further comprises a communication module and is configured for segmenting the ultrasonic Doppler shift raw data into a plurality of data packets and for associating the plurality of data packets with the plurality of HID channels; wherein the USB is configured for transmitting the plurality of data packets via the plurality of HID channels to a mobile computing device; the transmitting is for generating processed data from the ultrasonic Doppler shift raw data by the mobile computing device and for presenting the processed data.

One other technical problem is how to transmit the Doppler shift audio data to the mobile computing device via the USB HID Interface in order to generate a color-coded Doppler spectrum in the module. The HID transfer rate is typically designed for low-bandwidth data transfers and not for high- volume data such as Doppler shift audio samples. Displaying a color- coded Doppler spectrum on the mobile computing device depends on the following parameters, which define the size of the Doppler shift raw data: • Pulse Repetition Frequency (PRF): PRF is related to the rhythm at which the Doppler device operates. It's the frequency at which ultrasound pulses are emitted by the device. A PRF of 8 kHz, for example, means that 8,000 ultrasound pulses are sent out every second. This rate is crucial because it influences the device's ability to accurately measure how fast blood is flowing.

• Real and Imaginary Components: The sound waves that the Doppler picks up are complex signals. The device breaks down each sound wave into two parts: a 'real' part and an 'imaginary' part.

• Resolution: Each of these real and imaginary parts of the sound wave is recorded with a high level of detail, known as resolution. For example, 24 bit resolution means that for each part of the sound wave, the device can distinguish between more than 16 million different levels of information.

In another example, in a scenario where the Pulse Repetition Frequency (PRF) is 8 kHz, the audio data stream might consist of 8,000 samples per second, with each sample containing both real and imaginary components, each being 24 bits or 3 bytes in size. This amounts to 48,000 bytes per second that need to be transferred, not including additional data overhead. The standard HID protocol poses a limitation here; it is generally limited to a maximum of 64 bytes per packet for full-speed USB devices, with a frequency of one packet per millisecond, totaling a theoretical maximum transfer rate of 64,000 bytes per second. Additionally, the system accommodates the transfer of additional operational data such as status bytes, physical button presses and user interaction signals from the mobile computing device. This extra information adds to the overall data burden, increasing the overhead and exacerbating the limitations of the HID protocol. This limitation becomes a bottleneck when dealing with the Doppler data stream, which is near the upper limit of what HID can handle, leading to potential issues such as data congestion, latency, and the risk of packet loss. In a medical diagnostic context, any loss or delay in data can lead to inaccuracies in the diagnostic results, which is unacceptable.

One technical solution is a full-speed USB communication interface for communicating between the handheld vascular Doppler unit, the electronic inflation device and the module on the mobile computing device. In some embodiments, the communication is via the Human Interface Device (HID) protocol over a Universal Serial Bus (USB) port. In order to handle the bandwidth of transferring data, the data transfer is enhanced through the deployment of multiple HID channels. The multiple HID channels operate in parallel over a single USB data bus. The raw Doppler shift audio samples are split across multiple HID channels and then synchronized and merged on the mobile computing device prior to processing and display. Such a solution provides real-time transmission of complex vascular Doppler information such as raw Doppler shift audio samples. In such a solution, the system maintains universal USB and HID protocol compatibility, ensuring ease of use and immediate recognition by the mobile computing device. This solution eliminates the need for additional drivers or specialized software, maintaining the plug-and-play attributes inherent to HID interfaces.

In some embodiments, the communication between the handheld vascular Doppler device and the mobile device is wireless by using wireless protocols instead of, or in addition to, the wired USB interface. Such wireless protocols may be Wi-Fi or Bluetooth.

In some embodiments, the handheld vascular Doppler system, when connected to a mobile computing device, provides enhanced clinical reporting and compatibility with digital imaging and communications in Medicine (DICOM) standards, providing seamless and efficient workflow in the analysis, reporting, and communication of Doppler ultrasound data within clinical settings. In some embodiments, the system imports DICOM modality worklists. This function streamlines the process of associating patient information with specific Doppler diagnostic data and improves the accuracy and efficiency of patient data management. In some embodiments, the system transmits a final report directly to a Picture Archiving and Communication System (PACS). The report is achieved through multiple formats for versatility and compliance with existing hospital infrastructure. The system can create a series of Bitmap (BMP) images, where each image represents a page of the report, thereby maintaining the integrity of the document layout and content when viewed on various PACS stations.

In some embodiments, in addition to the Bitmap (BMP) format, the system may also transmit final reports as a series of joint photographic experts Group (JPEG) images. The final reports provide efficient data storage and transmission while preserving the necessary image quality for clinical evaluation. For comprehensive documentation purposes, in some embodiments, the system may transmit final reports as encapsulated Portable Document Format (PDF) files to PACS. This format ensures that the report remains unaltered and secure during electronic transmission. In some embodiments, the system is designed to handle the transmission of complex waveform data, converting and encapsulating captured Doppler waveforms as a series of images. This feature ensures that vital waveform information can be archived and retrieved with high fidelity, aiding in the longitudinal assessment of patient studies. In some embodiments, the module transmits a final report to PACS utilizing structured reporting DICOM protocols. Structured reporting includes critical patient details, which are pivotal for patient identification and associating the diagnostic imaging studies. The structured reporting encompasses study details such as identification, date, time, and examination specifics, thus providing a comprehensive overview of the diagnostic procedure. In some embodiments, the structured reporting includes detailed numerical and textual Doppler test results, presenting blood flow velocities, spectral waveform analyses and interpretive diagnostics in a structured format. Such reporting promotes standardization, interoperability, and ease of access to patient data across different healthcare systems.

One exemplary embodiment of the disclosed subject matter is a handheld vascular Doppler device; comprising: an ultrasonic pen Doppler probe configured for transmitting and receiving ultrasonic signals; a universal serial bus (USB) interface; the USB interface comprises a plurality of human interface device (HID) channels; and a control circuit, the control circuit configured for processing the ultrasonic signals to generate ultrasonic Doppler shift raw data; the control circuit further comprises a communication module and is configured for segmenting the ultrasonic Doppler shift raw data into a plurality of data packets and for associating the plurality of data packets with the plurality of hid channels; wherein the USB is configured for transmitting the plurality of data packets via the plurality of hid channels to a mobile computing device; the transmitting is for generating processed data from the ultrasonic Doppler shift raw data by the mobile computing device and for presenting the processed data.

According to some embodiments, the process data comprises a color-coded Doppler spectrum. According to some embodiments, the handheld vascular Doppler device is in communication with an electronic inflation device. According to some embodiments, the handheld vascular Doppler device comprises a Wi-Fi module configured for transmitting the plurality of data packets to the mobile computing device. According to some embodiments, the handheld vascular Doppler device comprises a Bluetooth module configured for transmitting the plurality of data packets to the mobile computing device. According to some embodiments, the handheld vascular Doppler system the processed data comprises a clinical report.

One other exemplary embodiment of the disclosed subject matter is a handheld vascular Doppler device; comprising: an ultrasonic pen Doppler probe configured for transmitting and receiving ultrasonic signals; an at least one button; the button is configured for receiving an event of user interaction with the button; a control circuit, the control circuit is configured for processing the ultrasonic signals to generate ultrasonic Doppler shift raw data; the control circuit further comprises a communication module; the control circuit is configured for associating the event with a command and for transferring the command and the ultrasonic Doppler shift raw data to a mobile computing device via the communication module; wherein the command is for controlling the operation of the mobile computing device.

According to some embodiments, the command is for processing the ultrasonic raw data on the mobile computing device. According to some embodiments, the handheld vascular Doppler unit further comprises a module embedded or installed in the mobile computing device; the module is configured for transmitting a command to control the functionality of the handheld vascular Doppler device.

One other exemplary embodiment of the disclosed subject matter is a handheld vascular Doppler system; the system comprises: a handheld vascular Doppler device adapted for generating ultrasonic raw data; an electronic inflation device adapted for inflating a pressure cuff; the electronic inflation device comprises an electric air pump, an electronic controlled valve and an electronic pressure sensor; the electronic inflation device is in connectivity with the handheld vascular Doppler device; a module being embedded or installed in a mobile computing device configured for receiving the ultrasonic raw data from the handheld vascular Doppler device and the electronic pressure sensor reading from the electronic inflation device, for processing the ultrasonic raw data and the pressure sensor reading and for presenting the processed data.

According to some embodiments, the electronic inflation device further comprises a Photoplethysmograph (PPG) port to connect a PPG sensor. According to some embodiments, the processed data comprises a clinical report. According to some embodiments, the handheld vascular Doppler device is physically attached to the mobile computing device via a mounting device.

One other exemplary embodiment of the disclosed subject matter is a case for carrying handheld vascular Doppler system, the case comprises a first housing attached to a second housing, the first housing is adapted for housing a handheld vascular Doppler unit and the second housing is adapted for housing a mobile device; the handheld vascular Doppler unit is configured for transmitting ultrasound data to the mobile computing device; the mobile computing device is configured for processing the ultrasound data; the case comprises a first hole in the a first outer space of the first housing and a second hole in a second outer space of the second housing, the first hole is adapted for connecting a first port of a USB cable to the handheld vascular Doppler unit and the second hole is adapted for connecting a second port of the USB cable to the mobile computing device for connecting the handheld vascular Doppler unit and the mobile computing device via the USB cable, the connecting is for the transmitting the ultrasonic data. According to some embodiments, the case further comprising a sleeve attached to the first outer surface or the second outer surface adapted for holding a probe of the handheld vascular Doppler unit; wherein the case further comprising a third hole in the first outer surface; the third hole is adapted for connecting a port of a probe cable to the handheld vascular Doppler wherein a port of the probe cable is connectable to the probe for providing communication between the probe and the handheld vascular Doppler unit via the probe cable. According to some embodiments, the handheld vascular Doppler unit further comprising a button for operating the mobile computing device as a result of user interaction with the button, wherein the first surface further comprising a fourth hole adaptable for surrounding the button for providing the user interaction. According to some embodiments, the handheld vascular Doppler unit further comprising a speaker to output Doppler audio, wherein the first surface further comprising a speaker opening adaptable for the speaker. According to some embodiments, at least part of the second surface being transparent for providing visibility and touch sensitivity to the mobile computing device. According to some embodiments, the case further comprising a handle.

In some aspects of the present invention relates to a non - transitory computer - readable medium comprising instructions which when executed by at least one control circuit causes the control circuit to perform the method of the present invention.

Embodiments of the invention may be implemented as a computer process (method), a computing system, or as an article of manufacture, such as a computer program product or a non- transitory computer-readable media. The computer program product may be a computer storage media readable by a computer system and encoding a computer program of instructions for executing a computer process on the computer and network devices. The computer program product may also be a propagated signal on a carrier readable by a computing system and encoding a computer program of instructions for executing a computer process.

THE BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The present disclosed subject matter will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which corresponding or like numerals or characters indicate corresponding or like components. Unless indicated otherwise, the drawings provide exemplary embodiments or aspects of the disclosure and do not limit the scope of the disclosure. In the drawings:

Fig. 1 shows a block diagram of an environment of the handheld vascular Doppler system, in accordance with some exemplary embodiments of the subject matter;

Fig. 2 shows a block diagram of the handheld vascular Doppler module, in accordance with some exemplary embodiments of the disclosed subject matter; Fig 3A shows a block diagram of a first view of an exemplary apparatus for carrying handheld vascular Doppler system, in accordance with some exemplary embodiments of the disclosed subject matter;

Fig 3B shows a block diagram of a second view of an exemplary apparatus for carrying handheld vascular Doppler system, in accordance with some exemplary embodiments of the disclosed subject matter;

Fig 3C shows a block diagram of a third view of an exemplary apparatus for carrying handheld vascular Doppler system, in accordance with some exemplary embodiments of the disclosed subject matter; and

Fig 4 shows a flowchart diagram of the protocol for transmitting data between the handheld vascular Doppler unit and the mobile computing device.

DETAILED DESCRIPTION

Fig. 1 shows a block diagram of handheld vascular Doppler environment, in accordance with some exemplary embodiments of the subject matter.

Environment 100 includes a handheld Doppler Unit 101, electronic inflation device 102, external system interface 103 and mobile computing device 104.

The handheld vascular Doppler Unit 101 is adapted for emitting ultrasonic waves for detecting and monitoring blood flow in the peripheral vasculature. The frequency and intensity of the waves are optimized to ensure accurate readings while maintaining patient safety.

The handheld vascular Doppler unit 101 includes an ultrasonic probe 1011, a control circuit 1012, a battery 1013, buttons 1014 and communication module 1015.

The ultrasonic probe 1011 is a pen Doppler that is attached to the patient skin and is configured for transmitting and receiving ultrasonic signals.

The control circuit 1012 is designed to control the operations of the Doppler device, including the operation of the buttons 1014. The control circuit 1012 may be, for example, a microcontroller.

The handheld vascular Doppler unit 101 is powered by the battery 1013 and is operated via buttons 1014. Battery 1013 may be a rechargeable battery, allowing for extended periods of usage. Battery 1013 may feature a battery level indicator, ensuring the awareness of clinicians to the remaining power.

The buttons 1014 are configured for operating the handheld vascular Doppler unit 101. The buttons 1014 are further configured for operating the module that is installed on the computing device 104. The buttons 1014 may be composed of Lexan with metal dome buttons for providing tactile feedback and durability and to be conducive to frequent clinical use. In some other embodiments, the buttons 1014 may be constructed from rubber or silicone, materials that may be preferable in certain clinical environments due to their ease of cleaning and resistance to contamination.

Such buttons 1014 may be fixed or programmable. The buttons 1014 may control, for example, the starting or stopping measurements, vessel label switching within the active protocol of the entire study and direct report printing or reviewing.

The buttons 1014 are in connectivity with the control circuity 1012. Upon the actuation of button 1014, the control circuit 1012 detects the event and transmits the event associated with the button to the mobile computing device 104.

The control circuit 1012 is configured for receiving an event of user interaction from the buttons 1014, for associating a command to the event and for transferring the command to the mobile computing device.

The control circuity 1012 may differentiate between a short press and a long press of the buttons 1014, each may trigger a certain action within the module. For instance, a short press might initiate a standard operation, such as starting or stopping the measurement, while a long press may activate a secondary function, such as switching to the next vessel label in the study protocol.

The communication module 1015 is configured for transmitting data between the handheld vascular Doppler unit 101 and the mobile computing device 104. In some embodiments, the communication module 1015 includes a USB interface, which provides a reliable and direct connection. In some embodiments, the communication module 1015 supports wireless interfaces such as Wi-Fi or Bluetooth.

The electronic inflation device 102 is adapted for inflating a pressure cuff.

The electronic inflation device 102 includes an electric air pump 1021, an electronic controlled valve 1022, an electronic pressure sensor 1023, a Photoplethysmograph (PPG) port 1024, a pressure cuff 1025 and a communication module 1026.

The electric air pump 1021 is configured for inflating the pressure cuff to a predetermined level. The operation of the electric air pump is controlled by the processing unit.

The electronic controlled valve 1022 is configured to hold the pressure at a predetermined level and regulate the rate at which the cuff deflates to ensure that the pressure decreases at a steady, controlled pace. The operation of the electronic controlled valve 1022 is controlled by the processing unit. The electronic pressure sensor 1023 is configured to monitor the pressure within the cuff continuously. The electronic pressure sensor 1023 provides real-time data on the pressure levels during both the inflation and deflation phases. This real time data is for determining blood pressure values and also for ensuring patient safety, as it helps prevent excessive inflation of the cuff. The electronic pressure sensor can be read by the processing unit.

The Photoplethysmography (PPG) 1024 is configured to be used in conjunction with the pressure cuff, particularly for blood pressure measurement setups. The Photoplethysmography (PPG) 1024 is configured for detecting blood volume, for changes in the microvascular bed of tissue using a light-based technology. The (PPG) 1024 typically attaches to a digit (like a toe or finger) or is placed on the skin over a major blood vessel. The Photoplethysmography (PPG) 1024 provides valuable data on blood flow characteristics and can be used to calculate parameters like the ankle-brachial index, toe-brachial index or assess venous reflux.

The pressure cuff 1025 is configured to be wrapped around the patient's limb (arm or leg). The pressure cuff 1025 is further configured to apply uniform pressure over the area it covers. The cuff is made from durable, comfortable material and may be in various sizes to accommodate different patients.

The communication module 1026 is configured for transmitting data between the electronic inflation device 102 and the mobile computing device 104. In some embodiments, the communication module 1026 includes a USB interface, which provides a reliable and direct connection. In some embodiments, the communication module 1026 supports wireless interfaces such as Wi-Fi or Bluetooth.

The External Systems Interface 103 includes medical data repositories such as DICOM and Picture Archiving and Communication System (PACS) and communicates with the mobile computing device via Wi-Fi communication 1031.

The Mobile Computing Device 104 is configured for communicating with the handheld vascular Doppler unit 101, the electronic inflation device 102 and the external interface 103, for analyzing the raw data, handling user interactions, for generating reports and for presenting the results to the user.

The mobile computing device 104 includes a communication module 1041 and module 1044. The communication module 1041 is configured for communicating with the handheld vascular Doppler unit 101, the electronic inflation device 102 and the external interface 103. The communication module 1041 includes a USB interface 105, a Bluetooth interface 106, and a WiFi interface 107. The operation of module 1044 is explained in greater detail in figure 2. The communication module 1015 transmits auditory signals and commands to the communication module 1041.

The communication module 1026 transmits raw data such as an electronic pressure sensor reading 1023 and PPG raw signals 1024 from the electronic inflation device 102 to the mobile computing device communication module 1041.

Fig. 2 shows a block diagram of the handheld vascular Doppler module, in accordance with some exemplary embodiments of the disclosed subject matter.

The module 1044 includes a module for processing user interaction 201, a module for controlling the Doppler operation 202, a digital signal processing module for raw data of Doppler shift audio samples 203, a controller for PPG operation 204, a digital signal processing for PPG raw data 205, a controller for pneumatic operation 206, a digital signal processing for pressure sensor reading 207, a module for displaying the processes data 208 and a module for handling user interface via touch screen 209.

The module for processing user interaction 201 is configured for receiving the commands from the handheld vascular Doppler device, for executing the command and for providing feedback to the user. The feedback may be in the form of visual cue on the mobile screen an auditory signal or tactile response from the button.

The module for controlling the Doppler operation 202 is configured for managing and directing the handheld vascular Doppler device. The module for controlling the Doppler operation 202 interacts with the handheld Doppler's microcontroller. The module for controlling the Doppler operation 202 translates user inputs such as button presses on the touchscreen into actionable commands that control the physical device. The module for controlling the Doppler operation 202 functions as a command hub by sending operational signals to the Doppler unit to regulate its various modes and settings.

The module for controlling the Doppler operation 202 transfers data to the handheld vascular Doppler 101.

The functions of the module for controlling the Doppler operation 202 include:

• Start/Stop Measurements: initiating and terminating the Doppler's measurement mode upon command. In one example the 'Start' command causes the Doppler unit to emit ultrasonic waves and to collect the returning echoes, which are used to analyze blood flow. In one other example the 'Stop' command ceases the activity of the device, effectively halting data collection and preserving the device's battery life and processing resources.

• Audio Volume Up/Down: The module for controlling the Doppler operation 202 is configured to adjust the audio output volume of the Doppler device. Increasing the volume is useful during manual assessments or when providing auditory feedback to patients. Decreasing the volume is useful s in noise-sensitive environments or to conserve battery power when audio feedback is not required.

The digital signal processing module 203 is configured for processing the raw audio data captured by the handheld vascular Doppler 101. Such raw data is made up of digital samples that represent the sound waves at discrete points in time. Such raw data includes sound waves reflected from moving blood cells with frequencies that are shifted due to the movement of blood within the body and generate the Doppler effect.

The digital signal processing module 203 receives data from the handheld Doppler 101.

The operation of the digital signal processing module includes:

• Filtering process: removing unrelated noise and external interference from the raw audio data to isolate the frequencies that correspond to the blood flow. The filtering is performed by a high-pass filter that removes low-frequency sounds, which are not relevant to the Doppler readings.

• Fast Fourier Transform (FFT): converting the time-domain signal (refer also as waveform) into the frequency domain. The FFT is for transforming the raw audio into a spectrum that shows the velocities of blood flow at various frequencies.

• Color-Coded Spectrum: transform the data from audio into a color-coded Doppler spectrum. This spectrum provides a visual representation of blood flow velocities, with different colors indicating different speeds. Visualization is for enabling to interpret the data quickly and accurately.

• Envelope Tracing Algorithm: identifying the outline or envelope of the Doppler signal from the processed audio data. The envelope represents the maximum blood flow velocity over time.

• Cardiac Cycle Detection Algorithm: The cardiac cycle detection algorithm is processed in parallel with the envelope tracing for identifying the individual cycles of heartbeats within the Doppler data. The identifying is by detecting the start and end points of each cardiac cycle. Such an algorithm is for segmenting the continuous Doppler data into discrete heartbeats.

• Parameters calculation algorithm: analyses the data gleaned from the envelope tracing and cardiac cycle detection to calculate various hemodynamic parameters. Such parameters may include peak systolic velocity, end-diastolic velocity, mean velocity, as well as indices such as Pulsatility Index (PI), Resistive Index (RI), and the Systolic/Diastolic (S/D) ratio. The algorithm may also compute the rise time (the time taken for blood flow to go from diastolic to peak systolic velocity) and heart rate based on the identified cardiac cycles. The calculated parameters are for diagnosing and assessing the severity of vascular conditions and are typically displayed to the clinician for interpretation and further clinical decision-making.

The controller for PPG operation 204 is configured for controlling the operations of the Photoplethysmography (PPG) sensor that is part of the electronic inflation device 102. The controlling is by translating the user inputs, such as touch commands, into commands that manage the sensor's operation.

The controller for PPG operation 204 transmits data to the electronic inflation device 102.

The digital signal processing for PPG raw data 205 is configured for processing the data collected from the photoplethysmography (PPG) sensor of the electronic inflation device 102. The digital signal processing for PPG raw data 205 transforms the raw PPG data into a format that is useful for medical analysis. The raw data from the PPG sensor typically includes a mix of useful signals and various types of noise or artifacts.

The digital signal processing for PPG raw data 205 receives data from the electronic inflation device 102.

The processing of the PPG raw data 205 includes:

• Filter for AC Signal: This process is configured for filtering the alternating current (AC) component of the PPG signal, which is related to the pulsatile changes in blood volume with each heartbeat. The filtering is for separating the vital fluctuations from other non-pulsatile components.

• Filter for DC Signal: This process is configured for filtering out the AC component to focus on the DC level, providing information about the overall blood volume and any non- pulsatile changes that occur. The direct current (DC) component represents the baseline level of blood volume.

• Cardiac Cycle Detection Algorithm: This process is configured for post-filtering. The process identifies the cardiac cycles within the PPG AC data. The process detects the rhythmic pattern associated with the heartbeats, which is crucial for assessing various cardiovascular parameters.

• Parameters Calculation Algorithm: The process is configured for calculating the various parameters from the filtered and for processing the PPG signal. The process may include metrics such as heart rate, amplitude, rise time and other indices that provide insights into cardiovascular health and the efficiency of blood circulation.

The control for pneumatic operation 206 is configured for managing the electronic inflation device's pneumatic functions. The control for pneumatic operations 206 manages the mechanical components responsible for the inflation and deflation of the pressure cuff used in blood pressure related measurements or pulse volume recording measurements. The control for pneumatic operation 206 translates user commands into mechanical actions via the electronic inflation device microcontroller.

The control for pneumatic operation 206 transmits commands to the electronic inflation device 102.

The functions of the controller for pneumatic operations 206 include:

• Start/Stop Measurements: The process in configured for initiating the inflation of the pressure cuff to commence blood pressure measurement and halts the process once adequate data has been collected or upon user command.

• Control Pressure Inflation Phase: This process is configured for managing the rate and extent of cuff inflation, ensuring that it reaches the pressure required for a specific clinical module.

• Control Hold Pressure Phase: the process is configured for maintaining the cuff at a steady pressure to stabilize the measurement conditions, which is critical for blood pressure readings or for pulse volume recording measurements.

• Control Pressure Deflation Phase: The process is configured for managing the rate of cuff deflation, for accurately determining systolic blood pressure. The deflation is neither too rapid nor too slow, as it can affect the measurement's accuracy.

The digital signal processing for pressure sensor reading 207 is configured for performing processing of the raw data captured by the electronic pressure sensor 1023 within the electronic inflation device 102.

The digital signal processing for pressure sensor reading 207 include:

• Filter for AC Signal: This process is configured for separating the alternating current (AC) component from the electronic pressure sensor's signal. The AC component is associated with the pulsations corresponding to the cardiac cycles, which is required for measurements such as pulse volume recording.

• Filter for DC Signal: The direct current (DC) component reflects the baseline pressure in the cuff, not influenced by the pulsations. Filtering out the AC signal allows for the analysis of the DC component, which provides essential information about the overall pressure applied by the cuff on the patient's limb.

• Cardiac Cycle Detection Algorithm: performing cardiac cycle detection algorithm. This algorithm is designed to identify the timing of the heartbeats as reflected in the pressure changes.

• Parameters Calculation Algorithm: Calculating key blood pressure parameters from isolated cardiac cycle data. This calculating includes the heart rate, amplitude and rise time. • Systolic Blood Pressure Detection Algorithm: pinpointing the precise moment at which the Doppler or PPG pulse reappears following the limb occlusion and graduate release.

The module for displaying the processed data 208 is configured for preparing the data to be presented to the user.

The module for displaying the processed data 208 includes:

• Color Coded Spectrum Display: The color coding allows for immediate and intuitive interpretation of the intensity level at each measured velocity within the blood vessel. This visual representation is particularly relevant for the Doppler ultrasound data, where different blood flow velocities are depicted in coded colors.

• PPG Curve Display: The processed photoplethysmography (PPG) data is visualized as a waveform that reflects the blood volume changes in the microvascular bed of tissue with each heartbeat. The display is crucial for assessing the cardiovascular system's health, especially the peripheral circulation.

• Pressure Curve Display: The display for blood pressure measurements shows the momentary pressure during the inflation and deflation cycles of the pressure cuff. This curve is instrumental in identifying systolic pressure points, which are the primary readings used in blood pressure assessment. In addition, the curve can also be used for the display of pulse volume recording waveform.

• Parameters Display: The calculated parameters, such as the Pulsatility Index (PI), Resistive Index (RI), Systolic/Diastolic (S/D) ratios, heart rate, and others derived from both Doppler and PPG data, are displayed in a numerical format.

The module for handling user interface via the touch screen 209 is configured for handling user commands for controlling the handheld vascular Doppler and/or the electronic inflation device. The user may tap, swipe, hover or perform any other gestures on the screen. The inputs of the user may be associated with starting or stopping measurements, adjusting settings, switching between different modes or views or inputting patient data. The module for handling user interface via touch screen 209 identifies the command associated with the user’s gesture, for example, a swipe may be identified as a scroll through various views of the Doppler data, while a tap may select a specific function.

Figures 3a, 3b and 3c show various side views of case 300. According to some embodiments, there is provided a case for carrying a handheld vascular Doppler system, the case includes a first housing attached to a second housing, the first housing is adapted for housing a handheld vascular Doppler unit and the second housing is adapted for housing a mobile device; the handheld vascular Doppler unit is configured for transmitting ultrasound data to the mobile computing device; the mobile computing device is configured for processing the ultrasound data; the case comprises a first hole in the first outer space of the first housing and a second hole in a second outer space of the second housing, the first hole is adapted for connecting a first USB port of a USB cable to the handheld vascular Doppler unit and the second hole is adapted for connecting a second USB port of the USB cable to the mobile computing device for connecting the handheld vascular Doppler unit and the mobile computing device via the USB cable. The USB connection is for communication between the handheld vascular Doppler unit and the mobile computing device to transmit the raw Doppler shift data.

According to some embodiments, the case further comprising a sleeve attached to the first outer surface or the second outer surface adapted for holding a probe of the handheld vascular Doppler unit; wherein the case further comprising a third hole in the first outer surface; the third hole is adapted for connecting a port of a probe cable to the handheld vascular Doppler wherein a port of the probe cable is connectable to the probe for providing communication between the probe and the handheld vascular Doppler unit via the probe cable. The communication is for transmitting and receiving ultrasonic data.

According to some embodiments, the handheld vascular Doppler unit further comprising a button for operating the mobile computing device as a result of user interaction with the button, wherein the first surface further comprising a fourth hole adaptable for surrounding the button for providing the user interaction. According to some embodiments, the handheld vascular Doppler unit further comprising a speaker to output Doppler audio, wherein the first surface further comprising a speaker opening adaptable for the speaker. According to some embodiments, at least part of the second surface is transparent for providing visibility to the mobile computing device and its touch screen. According to some embodiments, the case of further comprising a handle.

Fig 3A shows a block diagram of a first view of an exemplary apparatus for carrying handheld vascular Doppler system, in accordance with some exemplary embodiments of the disclosed subject matter.

Fig 3A shows the probe 1011, the sleeve 340, the first housing 310, the second housing 305, the probe cable 350, the second outer space 320, the USB cable 335 and the handle 370.

Fig 3B shows a block diagram of a second view of an exemplary apparatus for carrying handheld vascular Doppler system, in accordance with some exemplary embodiments of the disclosed subject matter.

Figure 3B shows the handle 370, the probe 1011, the sleeve 340, the probe cable 350, the USB cable 335, speaker opening 365, the fourth hole 360 and the first outer space 330. Fig 3C shows a block diagram of a third view of an exemplary apparatus for carrying handheld vascular Doppler system, in accordance with some exemplary embodiments of the disclosed subject matter.

Fig 3C shows the probe cable 350, the USB cable 335, the first hole 345, the second hole 325, the third hole 355, the first housing 310, the fourth hole 360, the speaker opening 365, the sleeve 340, the first outer space 330, the second housing (305), and the probe 1011.

Fig 4 shows a flowchart diagram of the protocol for transmitting data between the handheld vascular Doppler unit and the mobile computing device over a full-speed Universal Serial Bus (SUB) interface. According to some embodiments, in order to handle the bandwidth of transferring data, the data transfer is enhanced through the deployment of multiple Human Interface Device (HID) channels. The multiple HID channels operate in parallel over a single USB data bus. Such a solution provides real-time transmission of complex vascular Doppler information such as color-coded Doppler spectral data and auditory signals. In such a solution, the system maintains universal HID protocol compatibility, ensuring ease of use and immediate recognition by the mobile computing device. This solution eliminates the need for additional drivers or specialized software, maintaining the plug-and-play attributes inherent to HID interfaces.

According to some embodiments, the system provides multiple HID interfaces in parallel. According to some embodiments, the system increases the report size and utilizes a plurality of interfaces. The Doppler raw data is divided across these channels, effectively distributing the load and reducing the strain on any single data transfer path. Such a solution increases the performance demands on the mobile computing device and minimizes the risk of packet loss. The data is aggregated from the multiple HID interfaces and is reassembled by the module into a complete Doppler shift audio stream for further processing into a visual spectrum.

Referring now to the drawing

At block 400 the system performs Doppler data acquisition. The acquisition includes collecting ultrasonic data by the handheld vascular Doppler device. The data includes raw Doppler shift audio samples that are reflections of the ultrasonic waves from the moving blood within the patient's vessels.

At block 405 the system segments the data into smaller packets. In accordance with the requirements of the HID protocol.

At block 410 the segmented packets are distributed between the multiple HID interfaces. Each interface operates as a channel for transmitting the segmented packets. The system associates each. The distribution is for overcoming the bandwidth limitations of a single HID interface. At block 415 each HID interface transmits the data packets to the mobile computing device. The transmission is a convergence of multiple streams of data packets from the separate HID interfaces into a single receiving point on the mobile device.

At block 420 the module of the mobile computing device performs data reassembly. The reassembly is performed upon receiving the packets from all the channels. The reassembly regenerates the original continuous stream of Doppler audio data.

At block 425 the module performs buffer preparation. The module prepares the reassembled Doppler data stream for processing in a buffer. The buffer serves as a holding area for the digital signal processing steps.

At block 430 the Digital Signal Processing (DSP) module applies filtering to remove noise and to convert the time-domain data into a frequency-domain representation. The end result is a color-coded Doppler spectrum, which visualizes the blood flow velocities for clinical analysis.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

It should be noted that, in some alternative implementations, the functions noted in the block of a figure may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved.

Any of the steps, operations, or processes described herein may be performed or implemented with one or more hardware or software modules, alone or in combination with other devices. In one embodiment, a software module is implemented with a computer program product comprising a computer-readable medium containing computer program code, which can be executed by a computer control circuit for performing any or all of the steps, operations, or processes described.

Claims

CLAIMS What is claimed is:

1. A handheld vascular Doppler device; comprising: an ultrasonic pen Doppler probe configured for transmitting and receiving ultrasonic signals; a universal serial bus (USB) interface; said USB interface comprises a plurality of Human Interface Device (HID) channels; and a control circuit said, said control circuit configured for processing said ultrasonic signals to generate ultrasonic Doppler shift raw data; said control circuit further comprises a communication module and is configured for segmenting said ultrasonic Doppler shift raw data into a plurality of data packets and for associating said plurality of data packets with said plurality of HID channels; wherein said USB is configured for transmitting said plurality of data packets via said plurality of HID channels to a mobile computing device; said transmitting is for generating processed data from said ultrasonic Doppler shift raw data by said mobile computing device and for presenting said processed data.

2. The handheld vascular Doppler unit of claim 1 wherein said process data comprises a color coded Doppler spectrum.

3. The handheld vascular Doppler device of claim 1, wherein said handheld vascular Doppler device being in communication with an electronic inflation device.

4. The handheld vascular Doppler device of claim 1, wherein said handheld vascular Doppler device comprises a Wi-Fi module configured for transmitting said plurality of data packets to said mobile computing device.

5. The handheld vascular Doppler device of claim 1, wherein said handheld vascular Doppler device comprises a Bluetooth module configured for transmitting said plurality of data packets to said mobile computing device.

6. The handheld vascular Doppler system of claim 1, wherein said processed data comprises a clinical report.

7. A handheld vascular Doppler device; comprising: an ultrasonic pen Doppler probe configured for transmitting and receiving ultrasonic signals; an at least one button; said button is configured for receiving an event of user interaction with said button; a control circuit, said control circuit is configured for processing said ultrasonic signals to generate ultrasonic Doppler shift raw data; said control circuit further comprises a communication module; said control circuit is configured for associating said event with a command and for transferring said command and said ultrasonic Doppler shift raw data to a mobile computing device via said communication module; wherein said command is for controlling the operation of said mobile computing device.

8. The handheld vascular Doppler unit of claim 7 wherein said command is for processing said ultrasonic raw data on said mobile computing device.

9. The handheld vascular Doppler unit of claim 7 further comprises a module embedded or installed in said mobile computing device; said module is configured for transmitting a command to control the functionality of said handheld vascular Doppler device.

10. A handheld vascular Doppler system; said system comprises: a handheld vascular Doppler device adapted for generating ultrasonic raw data; an electronic inflation device adapted for inflating a pressure cuff; said electronic inflation device comprises an electric air pump, an electronic controlled valve and an electronic pressure sensor; said electronic inflation device is in connectivity with said handheld vascular Doppler device; a module being embedded or installed in a mobile computing device configured for receiving said ultrasonic raw data from said handheld vascular Doppler device and said electronic pressure sensor reading from said electronic inflation device, for processing said ultrasonic raw data and said pressure sensor reading and for presenting said processed data.

11. The handheld vascular Doppler system of claim 9, wherein said electronic inflation device further comprises a Photoplethysmograph (PPG) port to connect a PPG sensor.

12. The handheld vascular Doppler system of claim 9, wherein said processed data comprises a clinical report.

13. The handheld vascular Doppler device of claim 1, wherein said handheld vascular Doppler device is physically attached to said mobile computing device via a mounting device.

14. A case for carrying handheld vascular Doppler system, said case comprises a first housing attached to a second housing, said first housing is adapted for housing a handheld vascular Doppler unit and said second housing is adapted for housing a mobile device; said handheld vascular Doppler unit is configured for transmitting ultrasound data to said mobile computing device; said mobile computing device is configured for processing said ultrasound data; said case comprises a first hole in said a first outer space of said first housing and a second hole in a second outer space of said second housing, said first hole is adapted for connecting a first port of a USB cable to said handheld vascular Doppler unit and said second hole is adapted for connecting a second port of said USB cable to said mobile computing device for connecting said handheld vascular Doppler unit and said mobile computing device via said USB cable, said connecting is for said transmitting said ultrasonic data.

15. The case of claim 14, further comprising a sleeve attached to said first outer surface or said second outer surface adapted for holding a probe of said handheld vascular Doppler unit; wherein said case further comprising a third hole in said first outer surface; said third hole is adapted for connecting a port of a probe cable to said handheld vascular Doppler wherein a port of said probe cable is connectable to said probe for providing communication between said probe and said handheld vascular Doppler unit via said probe cable.

16. The case of claim 14, wherein said handheld vascular Doppler unit further comprising a button for operating said mobile computing device as a result of user interaction with said button, wherein said first surface further comprising a fourth hole adaptable for surrounding said button for providing said user interaction.

17. The case of claim 14, wherein said handheld vascular Doppler unit further comprising a speaker to output Doppler audio, wherein said first surface further comprising a speaker opening adaptable for said speaker.

18. The case of claim 14, wherein at least part of said second surface being transparent for providing visibility and touch sensitivity to said mobile computing device.

19. The case of claim 14, further comprising a handle.