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WO2025101666A1 - Procédés, systèmes et dispositifs de surveillance de la santé vasculaire par l'intermédiaire d'un dispositif implantable/insérable - Google Patents

Procédés, systèmes et dispositifs de surveillance de la santé vasculaire par l'intermédiaire d'un dispositif implantable/insérable Download PDF

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WO2025101666A1
WO2025101666A1 PCT/US2024/054804 US2024054804W WO2025101666A1 WO 2025101666 A1 WO2025101666 A1 WO 2025101666A1 US 2024054804 W US2024054804 W US 2024054804W WO 2025101666 A1 WO2025101666 A1 WO 2025101666A1
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vascular health
ultrasonic sensors
cases
electrical field
scanner
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Kyle FREDERICKS
Andres ORTEGA GARCIA
Marie Muller
Jean BISMUTH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0891—Clinical applications for diagnosis of blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/488—Diagnostic techniques involving Doppler signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/04—Measuring blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/06—Measuring blood flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/4472—Wireless probes

Definitions

  • Peripheral Vascular Occlusion affects more than 50 million people in the US alone. Peripheral Vascular Occlusion can oftentimes be asymptomatic and its late diagnosis can lead to severe vascular events such as leg amputation, stroke or heart attacks. Managing Peripheral Vascular Occlusion accounts for over $20 billion of annual expenditure in the US.
  • the devices, systems, and methods described herein may be configured for monitoring a medical condition through implantation or insertion of the device near the specifically targeted region designated for diagnostic examination.
  • a sensor module comprising one or more ultrasonic sensors, wherein said sensor module is configured to detect a distance from said one or more ultrasonic sensors to a vessel surface and to adjust an angle between an ultrasound beam released from said one or more ultrasonic sensors and said vessel surface based at least in part on the distance from said one or more ultrasonic sensors to said vessel surface, and said one or more ultrasonic sensors is configured to measure one or more of vascular health signals of said vessel; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • adjusting said angle between said ultrasound beam and said vessel surface comprises adjusting one or more beam-forming sequences. In some cases, adjusting said one or more beam-forming sequences comprising adjusting an output from said one or more ultrasonic sensors.
  • said one or more ultrasonic sensors comprise pulse-echo mode, wherein pulse-echo is configured to measure a frequency content, attenuation, time behavior, diffusion properties of backscattered signals, statistical properties of backscattered signals, or any combination thereof of an ultrasonic wave.
  • said one or more ultrasonic sensors comprises B-mode, wherein B- mode is configured to generate a two-dimensional ultrasound image or a plane wave image.
  • said one or more ultrasonic sensors is configured to conduct a time-of-flight ultrasound measurement. In some cases, said one or more ultrasonic sensors is configured to self-locate by creating a depth map in relation to said vessel surface, wherein said map comprises one or more distances between said one or more ultrasonic sensors and one or more of surrounding tissue, and between said one or more ultrasonic sensors and one or more vascular structures. In some cases, said one or more ultrasonic sensors is capable of selfcorrecting said angle between said one or more ultrasonic sensors and said vessel surface by using said depth map, thereby correcting a Doppler angle offset. In some cases, said device further comprises one or more electrical field sensors, wherein said one or more electrical field sensors is configured to measure an electrical field signal related to said vessel; and wherein said signal processor is configured to receive said electrical field signal.
  • a sensor module comprising one or more ultrasonic sensors and one or more electrical field sensors, wherein said one or more ultrasonic sensors is configured to measure one or more vascular health signals and wherein said one or more electrical field sensors is configured to measure an electrical field signal related to a vessel; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals and said electrical field signal; wherein said sensor module and said computer module are operably linked to each other.
  • said one or more ultrasonic sensors comprises one or more Capacitive Micro-Machined Ultrasonic Transducers (CMUTs).
  • CMUTs Capacitive Micro-Machined Ultrasonic Transducers
  • said one or more of ultrasonic sensors comprises one or more Piezo Micro-Machined Ultrasonic Transducers (PMUTs). In some cases, said one or more of ultrasonic sensors comprises one or more Piezoelectric single crystals. In some cases, said one or more vascular health signals comprises one or more ultrasound waveforms, wherein said one or more ultrasound waveforms are configured to reflect vascular structure, plaque structure, or both. In some cases, said one or more ultrasound waveforms are configured to reflect blood flow via one or more Doppler measurements. In some cases, said one or more ultrasonic sensors is configured to be arranged in a linear array. In some cases, said one or more ultrasonic sensors is configured to be arranged in a phased array.
  • PMUTs Piezo Micro-Machined Ultrasonic Transducers
  • said one or more of ultrasonic sensors comprises one or more Piezoelectric single crystals.
  • said one or more vascular health signals comprises one or more ultrasound waveforms, wherein said one or more ultrasound waveforms are configured to
  • said one or more ultrasonic sensors is configured to be arranged in a curvilinear array. In some cases, said one or more ultrasonic sensors is configured to be arranged in a one- dimensional array or a two-dimensional array. In some cases, said one or more electrical field sensors comprises one or more bio-compatible metals. In some cases, said one or more electrical field sensors comprises one or more dielectric materials. In some cases, said one or more electrical field sensors comprises one or more inter-digitated electrodes configured to enhance signal strength of an electrical field signal received by said one or more electrical field sensors. In some cases, said device further comprises a sensor carrier, wherein said one or more ultrasonic sensors, said one or more electrical field sensors, or both are configured to be disposed on said sensor carrier.
  • said computer module further comprises a power receiver, wherein said power receiver is configured to receive power from an external power source.
  • said computer module further comprises a data transceiver, wherein said data transceiver is configured to communicate said one or more vascular health signals and said electrical field signal to an external scanner.
  • said computer module further comprises a signal transceiver, wherein said signal transceiver is configured to digitize said one or more vascular health signals and said electrical field signal for wireless transmission to said external scanner by said data transceiver.
  • said signal transceiver is configured to process ultrasound waveforms to: extract quantitative ultrasound metrics, wherein said quantitative ultrasound metrics comprise one or more of signal statistical properties, time of flight, attenuation, envelope metrics, and backscatter metrics; form one or more images; or extract a Doppler measurement.
  • said sensor module and said computer module are operably linked to each other via a connecting tether.
  • said sensor module and said computer module are operably linked to each other by fusion of both modules into a single integrated body.
  • said single integrated body comprises an unfolding feature.
  • said unfolding feature is configured to stabilize an angle between said sensor module and an adjacent vessel upon implantation or insertion of said device.
  • said sensor module and said computer module are operably linked to each other via a near-field wireless connection.
  • a sensor module comprising one or more ultrasonic sensors configured to measure one or more vascular health signals, wherein said one or more ultrasonic sensors is arranged in a three-dimensional helical shape configuration; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • devices for monitoring vascular health in a subject comprising: a sensor module comprising one or more electrical field sensors configured to measure one or more of vascular health signals, wherein said one or more electrical field sensors is arranged in a three-dimensional helical shape configuration; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • said one or more ultrasonic sensors or said one or more electrical field sensors is disposed on a sensor carrier.
  • said sensor carrier is arranged in a three-dimensional helical shape.
  • said sensor carrier is operably linked to said one or more ultrasonic sensors via an electric communication.
  • said sensor carrier is operably linked to said one or more electrical field sensors via an electric communication.
  • said sensor carrier comprises a memory metal wire, wherein said memory metal wire is configured to enable real-time adjustment of a positioning of said one or more ultrasonic sensors or said one or more electrical field sensors.
  • said memory metal wire comprises a nitinol metal wire.
  • said device is configured to be hermetically sealed by an overmolding biocompatible thermoplastic elastomer (TPU).
  • said device is configured to be hermetically sealed by lamination of a biocompatible sheet of elastic polymer.
  • said laminated biocompatible sheet of elastic polymer comprises one or more of suture holes configured to allow surgical attachment of said computer module to said subject’s tissue.
  • a sensor module comprising one or more ultrasonic sensors configured to measure one or more vascular health signals of said vessel, wherein said sensor module is configured to evaluate said device’s position relative to a vessel upon insertion of said device in said subject; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • said device further comprises an unfolding feature.
  • said unfolding feature is configured to unlatch.
  • said unfolding feature is configured to unlock.
  • said unfolding feature comprises a spring extension.
  • said unfolding feature comprises a bistable metal flexure.
  • said device further comprises hyperechoic material situated at one or more ends of said device.
  • said hyperechoic material situated at one or more ends of said device comprises a tip that is configured to be reflective to ultrasound, wherein said tip is configured to determine said device’s position relative to said vessel.
  • said tip is configured to be used for calibration of said device by comparing an actual location of said device against an intended location.
  • said tip is configured to verify a position of said device by comparing an intended location against an actual location after said device has been calibrated.
  • a system for monitoring vascular health in a subject comprising: a vascular health monitoring device, comprising: a sensor module comprising one or more ultrasonic sensors, wherein said sensor module is configured to detect a distance from said one or more ultrasonic sensors to a vessel surface and to adjust an angle between said one or more ultrasonic sensors and said vessel surface based at least in part on the distance from said one or more ultrasonic sensors to said vessel surface, and said one or more ultrasonic sensors is configured to measure one or more of vascular health signals of said vessel; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals and said electrical field signal; wherein said sensor module and said computer module are operably linked to each other; and a scanner, wherein said scanner receives one or more vascular health data comprising said one or more vascular health signals and said electrical field signal from said vascular health monitoring device.
  • said one or more vascular health signals and said electrical field signal are configured to be transmitted via internet to said scanner.
  • the system can further comprise a cloud infrastructure.
  • said one or more vascular health signals and said electrical field signal are configured to be transmitted to one or more of said scanner and said cloud infrastructure.
  • said scanner is configured to communicate with said cloud infrastructure through an internet connection.
  • said cloud infrastructure is configured to share monitoring results through a clinical dashboard, a web-based interface, or an app-based interface.
  • said scanner comprises an external scanner, wherein said external scanner is external to said subject’s body.
  • said scanner is configured to act as an external power source, wherein said scanner is configured to supply power to said vascular health monitoring device.
  • said scanner is configured to communicate with said vascular health monitoring device through one or more of: Bluetooth, custom RF transceiver, or induction coil. In some cases, said scanner is configured to be powered by power cable, battery, or both. In some cases, said scanner is configured to be USB rechargeable. In some cases, the system further comprises an insertion device, wherein said insertion device is configured to insert said vascular health monitoring device into said subject. In some cases, said insertion device comprises hyperechoic material at one or more ends. In some cases, said hyperechoic material at one or more ends of said insertion device comprises a tip that is reflective to ultrasound. In some cases, said tip is configured to determine said insertion device’s position relative to a vessel.
  • vascular health monitoring device comprising: a sensor module comprising one or more ultrasonic sensors, wherein said sensor module is configured to detect a distance from said one or more ultrasonic sensors to a vessel surface and to adjust an angle between said one or more ultrasonic sensors and said vessel surface based at least in part on the distance from said one or more ultrasonic sensors to said vessel surface, and said one or more ultrasonic sensors is configured to measure one or more of vascular health signals of said vessel; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals and said electrical field signal; wherein said sensor module and said computer module are operably linked to each other; collecting and analyzing one or more data points comprising said one or more vascular health signals and said electrical field signal; and transmitting said analyzed one or more data points to a processor.
  • said collecting further comprises measuring a frequency content, an attenuation, a time behavior, a plurality of diffusion properties of backscattered signals, a plurality of statistical properties of backscattered signals, or any combination thereof of an ultrasonic wave.
  • said collecting further comprises generating a two-dimensional ultrasound image.
  • said collecting further comprises conducting a time-of-flight ultrasound measurement.
  • said analyzing further comprises digitizing said one or more vascular health signals comprising a measurement of ultrasonic waveforms into a compressed format, encoded format, or both.
  • said analyzing further comprises processing said digitized measurement of ultrasonic waveforms into a format that is readable by said scanner.
  • the method further comprises powering said vascular health monitoring device via an external power source.
  • said external power source comprises said scanner.
  • the method further comprises interpreting said transmitted one or more data points.
  • said processor comprises a scanner.
  • said interpreting comprises combining said transmitted one or more data points to generate one or more trends in said data points.
  • said interpreting occurs in an external computer processing system.
  • said external computer processing system comprises a cloud infrastructure.
  • the method further comprises generating a digital report for a health professional based on said interpretation of said transmitted one or more data points.
  • collecting and analyzing comprises steering an ultrasonic beam provided by the one or more ultrasonic sensors.
  • steering comprises autonomous steering by the sensor module.
  • adjusting an angle between said one or more ultrasonic sensors and said vessel surface is further based at least in part on one or more of time of flight assessment or image segmentation methods.
  • the image segmentation methods comprise machine learning methods.
  • collecting and analyzing one or more data points comprises processing said one or more vascular health signals and said electrical field signal, extracting metrics from said one or more vascular health signals and said electrical field signal, applying one or more predictive data models to said one or more metrics based on said one or more vascular health signals and said electrical field signal.
  • metrics comprise one or more of blood flow velocity, turbulence, vessel diameter, tissue characterization of densities and plaque levels, or flow rate.
  • transmitting comprises transmitting said analyzed one or more data points wirelessly to a wireless device or mobile phone for one or more of real-time display, real-time signal processing, or cloud storage and processing.
  • the method can further comprise monitoring the transmitted one or more data points, wherein monitoring comprises continuous data transmission and analysis to one or more of said mobile device or said cloud storage with integration capabilities for Electronic Health Records.
  • vascular health monitoring devices comprising: providing the devices as described above; collecting and analyzing one or more data points comprising said one or more vascular health signals and said one or more of electrical field signals using said vascular health monitoring device; and transmitting said analyzed one or more data points to a processor.
  • vascular health monitoring devices comprising: providing the systems as described above; collecting and analyzing one or more data points comprising said one or more vascular health signals and said one or more of electrical field signals using said vascular health monitoring device; and transmitting said analyzed one or more data points to said scanner.
  • a vascular monitoring device comprising a sensor module and a computer module.
  • said computer module comprises a power management system configured to function on low power input.
  • power management system is configured to integrate with energy-harvesting technologies to power the device over at least thirty minutes.
  • the power management system comprises a battery.
  • FIG. 1A provides an exploded perspective view of an example implantable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. IB provides a top-down view of an example implantable monitoring device showing its circuitry, in accordance with embodiments disclosed herein.
  • FIG. 1C provides a perspective view of an example implantable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. ID depicts another perspective view of an example implantable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. IE depicts another perspective view of an example implantable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. IF provides another perspective view of an example implantable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. 1G provides a perspective top view of an example implantable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. 2A provides an exploded perspective view of an example insertable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. 2B provides a perspective view of an example insertable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. 2C provides a perspective top view of an example insertable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. 2D provides another perspective view of an example insertable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. 2E provides a zoomed in top view of an example insertable monitoring device, in accordance with embodiments disclosed herein.
  • FIGS. 3A-3I depict exploded (FIG. 3A), perspective (FIGS. 3D, 3G-3I), top- down (FIGS. 3B-3C, 3E), and side (FIG. 3F) views of an alternate example insertable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. 3J shows example internal components of an example insertable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. 4A depicts an example embodiment of an insertion tool, in accordance with embodiments disclosed herein.
  • FIG. 4B depicts a side view of an example embodiment of an insertion tool, in accordance with embodiments disclosed herein.
  • FIGS. 5A-5H depicts perspective (FIGS. 5A-5B, 5C, 5E) and side (FIGS. 5D, 5F-5H) views of an alternate insertion tool in accordance with embodiments disclosed herein.
  • FIGS. 6A-6B depicts perspective (FIG. 6A) and top-down (FIG. 6B) views of an alternate insertion tool in accordance with embodiments disclosed herein.
  • FIGS. 7A-7F depict perspective (FIGS. 7A-7B, 7D-7E) and side (FIGS. 7C, 7F) views of an alternate insertion tool in accordance with embodiments disclosed herein.
  • FIGS. 8A-8C depict top-down (FIG. 8A), side (FIG. 8B), and perspective (FIG.
  • FIG. 9A depicts an example embodiment of a power delivery device showing its circuitry, in accordance with embodiments disclosed herein.
  • FIG. 9B provides a perspective top view of an example embodiment of a power delivery device, in accordance with embodiments disclosed herein.
  • FIG. 9C provides another perspective top view of an example embodiment of a power delivery device, in accordance with embodiments disclosed herein.
  • FIG. 9D provides a top view of an example embodiment of a power delivery device, in accordance with embodiments disclosed herein.
  • FIG. 9E provides another top view of an example embodiment of a power delivery device, in accordance with embodiments disclosed herein.
  • FIG. 9F provides a side view of an example embodiment of a power delivery device, in accordance with embodiments disclosed herein.
  • FIG. 9G provides another side view of an example embodiment of a power delivery device, in accordance with embodiments disclosed herein.
  • FIGS. 10A-10F show a series of snapshots of an example method for inserting an example insertable monitoring device, in accordance with embodiments disclosed herein.
  • FIG. 11 provides an example embodiment flow chart depicting a method for monitoring a medical condition according to an embodiment described herein.
  • the present disclosure proposes an implantable vascular health monitoring device that seeks to overcome the aforementioned limitations and usher in a new era of personalized and optimized vascular health monitoring.
  • the present disclosure system stands out by facilitating real-time surveillance coupled with post-measurement processed analysis, tailored to adapt to individual vascular structures. Consequently, it enables personalized and optimized health monitoring over extended durations without necessitating adjustments to the placement or setup, ensuring seamless and frequent data acquisition.
  • the present disclosure is configured to act as a fully enclosed system that is meant to live inside the body, whether under the skin, intramuscularly, or on a target vessel.
  • Doppler measurements can be more reliably captured when ultrasound waves are released as close to parallel flow as possible.
  • Doppler probes may be built to transmit signals at a given angle.
  • this issue is overcome by implementing a plurality of ultrasonic elements on an array to determine its angle to the vessel and additionally correct said angle of Doppler signals to steer a Doppler beam in any direction or compensate algorithmically for the angle offset.
  • phased array transducers can autonomously measure vessel angle, steer ultrasonic beams, allowing for the correction of mis-aligned vessel insonation ensuring accurate blood flow measurements without specialized user skills, enabling at-home monitoring for PAD (peripheral arterial disorder) and related conditions.
  • the system can automatically adjust its Doppler angle using advanced algorithms that include time of flight assessment and image segmentation methods, including but not limited to machine learning methods or vessel angle measurements through individual flow velocity measurements at specific depths through multiple insonation points along the vessel . This can provide accurate real-time blood flow despite non-axial sensor placement or positioning.
  • the medical condition comprises peripheral vascular occlusion; such as atherosclerosis, vessel ischemia, vascular thrombosis, vascular stenosis, aneurysm, dissection or a combination thereof.
  • Disclosed herein are devices, systems, and methods for improving vascular health monitoring through in-situ sensing.
  • the devices, systems, and methods provided herein facilitate daily user-friendly surveillance of vessel conditions in a home setting.
  • devices for monitoring vascular health in a subject comprising a sensor module comprising one or more ultrasonic sensors, wherein said one or more ultrasonic sensors is configured to measure one or more vascular health signals; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module are operably linked to each other.
  • the sensor module can further comprise one or more electrical field sensors, wherein said one or more electrical field sensors is configured to measure an electrical field signal related to a vessel.
  • the signal processor is configured to receive said electrical field signal.
  • the sensor module can comprise other sensors that are configured to measure vascular health signals.
  • a device can be either implanted or inserted to position a sensor near a specifically targeted vascular region designated for diagnostic examination, guided by a healthcare practitioner with specialized knowledge in vascular health.
  • This device can comprise a sensor module, a computer module, and an interconnect.
  • the device can further comprise a battery in one or more of the insertable or implantable device or the scanner reader.
  • the vascular health monitoring device is an implantable device that comprises a sensor module 15, a computer module 1, and an interconnect 2.
  • sensor module 15 comprises one or more piezo elements 10, one or more E-Field sensors 11, an inner shape memory alloy in the form of a strip 12, an outer shape memory alloy in the form of a wire 13, and a tension spring strip 14.
  • the inner shape memory alloy in the form of a strip is wider that the outer shape memory alloy in the form of a wire.
  • the sensor module 15 can comprise one or more piezo elements 10, one or more E-Field sensors 11, an inner shape memory alloy in the form of a strip 12, and an outer shape memory alloy in the form of a wire 13.
  • the outer shape memory alloy in the form of a wire 13 is external to the inner shape memory alloy in the form of a strip, such that if laid flat, the inner strip 12 can be in the center and the outer wire 13 can be along the edges.
  • the sensor module 15 can comprise one or more piezo elements 10, one or more E-Field sensors 11, a shape memory alloy in the form of a strip 12, and a tension spring strip 14.
  • the sensor module 15 can comprise a shape memory alloy in the form of a strip 12.
  • the sensor module 15 can comprise one or more piezo elements 10, one or more E-Field sensors 11, and a shape memory alloy in the form of a wire 13.
  • an external view of sensor module 15 can comprise a tension spring strip 14.
  • computer module 1 comprises an induction coil 3, a microprocessor 4, a communication antenna 5, an EMI shield material 6, a top layer of elastomeric coating 7, a bottom layer of elastomeric coating 8, and suture holes 9.
  • an internal view of computer module 1 can comprise an induction coil 3, a microprocessor 4, and a communication antenna 5.
  • an external view of computer module 1 can comprise a top layer of elastomeric coating 7, and a bottom layer of elastomeric coating 8.
  • the vascular health monitoring device is an insertable device that comprises a sensor module 20, a computer module 1, and an interconnect 2.
  • the sensor module 20 can comprise one or more piezo elements 10, one or more E-Field sensors 11, a stiffener strip 21, a transducer array carrier structure 22, multiple hyperechoic reflective material areas 23 and 24, and an unfolding positional securement feature 25.
  • the sensor module 20 can comprise one or more piezo elements 10 and a stiffener strip 21.
  • FIG. 2C displays an external view of the sensor module 20.
  • the sensor module 20 can comprise one or more piezo elements 10, a transducer array carrier structure 22, and an unfolding positional securement feature 25.
  • the sensor module 20 can comprise one or more piezo elements 10 and an absence of material that is filled with air 26.
  • the absence of material that is filled with air 26 can act as air backing against the piezo element to directionally bias the ultrasonic energy towards a target vessel using a high difference of acoustic impedance.
  • computer module 1 comprises an induction coil 3, a microprocessor 4, a communication antenna 5, an EMI shield material 6, a top layer of elastomeric coating 7, a bottom layer of elastomeric coating 8, and suture holes 9.
  • an internal view of computer module 1 can comprise an induction coil 3, a microprocessor 4, and a communication antenna 5.
  • an external view of computer module 1 can comprise a top layer of elastomeric coating 7, and a bottom layer of elastomeric coating 8.
  • the device can be hermetically sealed by over-molding biocompatible elastomer.
  • the device can be hermetically sealed by over-molding biocompatible thermoplastic elastomer.
  • the device can be hermetically sealed by overmolding biocompatible thermoplastic polyurethane (TPU).
  • the device can be hermetically sealed by over-molding biocompatible polyester-based thermoplastic polyurethane (TPU), including but not limited to thermoplastic polyurethane derived from adipic acid esters.
  • TPU thermoplastic polyurethane
  • the device can be hermetically sealed by over-molding biocompatible polyether-based thermoplastic polyurethane, including but not limited to thermoplastic polyurethane derived from tetrahydrofuran (THF) ethers.
  • THF tetrahydrofuran
  • the device can be hermetically sealed by lamination of biocompatible sheet of elastic polymer, creating an uninterrupted surface that can be sterilized and is compatible with body tissue.
  • the device can be hermetically sealed by lamination of biocompatible sheet of thermoplastic elastomer.
  • the device can be hermetically sealed by lamination of biocompatible sheet of thermoplastic polyurethane, including but not limited to thermoplastic polyurethane derived from adipic acid esters.
  • the device can be hermetically sealed by lamination of biocompatible sheet of thermoplastic polyurethane, including but not limited to thermoplastic polyurethane derived from tetrahydrofuran (THF) ethers.
  • THF tetrahydrofuran
  • a feature of the elastic lamination is suture holes 9, which allow for surgical attachment of the computer module to bodily tissue.
  • the device comprises a sensor module with ultrasonic transducers mounted on an adjustable sensor carrier.
  • the sensor module can comprise E- Field sensors mounted on an adjustable sensor carrier.
  • the sensor module can comprise both ultrasonic and E-Field sensors mounted on an adjustable sensor carrier.
  • E- Field sensors can be electrical field sensors.
  • the sensor module can comprise ultrasonic transducers which are configured and aligned to directly interface with the targeted vessel, enabling the detection of a spectrum of vascular abnormalities including, but not limited to, occlusion, turbulent blood flow, irregular flow rates, abnormal pressure patterns, or any combination thereof.
  • the device comprises proximity sensors affixed to the target vessel to detect fluctuations in the electrical field induced by vascular issues, such as occlusion, turbulent blood flow, irregular flow rates, abnormal pressure patterns, or any combination thereof.
  • vascular issues such as occlusion, turbulent blood flow, irregular flow rates, abnormal pressure patterns, or any combination thereof.
  • other sensors can be used to measure vascular health signals and vascular abnormalities, including, but not limited to, occlusion, turbulent blood flow, irregular flow rates, abnormal pressure patterns, or any combination thereof.
  • an implantable sensor module comprises one or more of: a piezo element, an E-Field sensor, a shape memory alloy in the form of a strip, a shape memory alloy in the form of a wire, and a tension spring strip.
  • an insertable sensor module comprises one or more of: a piezo element, an E-Field sensor, a stiffener strip, a transducer array carrier structure, multiple hyperechoic reflective material areas, and an unfolding positional securement feature.
  • an ultrasonic sensor comprises one or more piezo elements 10.
  • piezo element 10 comprise Piezoelectric single crystals.
  • the ultrasonic sensor can comprise an ultrasonic transducer.
  • the ultrasonic transducer can comprise a Capacitive Micro-Machined Ultrasonic Transducers (CMUT).
  • the ultrasonic transducer can comprise a Piezo Micro-Machined Ultrasonic Transducers (PMUT).
  • the transducers conduct measurements to collect ultrasound waveforms. These waveforms can comprise vascular health signals.
  • the ultrasound waveforms can reflect vascular structure, plaque structure, or both.
  • the ultrasound waveforms can reflect blood flow via one or more Doppler measurements.
  • the Doppler measurements are conducted in a configuration that is planar across multiple sensory elements, allowing for the transmission and reception of Doppler flow data.
  • the Doppler measurements are conducted in a configuration where the sensor forms an angle with the vessel.
  • the angle is evaluated by ultrasonic pulse echo measurement prior to the Doppler measurements. facilitating the accurate measurement of flow velocities.
  • the device comprises a pulse-echo mode.
  • pulse-echo can be used for quantitative characterization of the vessel wall and any potential occlusions by measuring the frequency content, attenuation, time behavior, diffusion and statistical properties of the backscattered signals, or any combination thereof, yielding a comprehensive analysis of vascular health.
  • Signal statistical properties can include, but are not limited to, envelope statistics.
  • Envelope metrics can be measured using models such as, but not limited to, homodyned-K or Nakagami models.
  • Backscatter metrics can include but are not limited to, backscatter coefficients and their spectral properties, for example midband fit, spectral slope, and intercept.
  • the analysis of vascular health can be based on, but is not limited to, occlusion, turbulent blood flow, irregular flow rates, and abnormal pressure patterns, or any combination thereof.
  • the ultrasonic transducers of piezo element 10 are strategically arrayed across the sensor carrier to interface with the selected vessel, emit ultrasonic waves that may transmit through, reflect, or deflect at various interfaces within the vessel. In some cases, positioning of the ultrasonic transducers is essential for mapping the vessel's diameter measurements during systolic and diastolic periods. In some cases, the ultrasonic transducers of piezo element 10 are arranged in a linear array. The ultrasonic transducers can be arranged in a phased array. The ultrasonic transducers can be arranged in a curvilinear array. The ultrasonic sensors can be arranged in a one-dimensional or two-dimensional array.
  • E-Field sensor 11 can comprise electrical field sensors.
  • E-Field sensor 11 can be affixed to the target vessel which detects the fluctuations in the electrical field induced by the irregularities of targeted vessel such as, but not limited to, occlusion turbulent blood flow, irregular flow rates, and abnormal pressure patterns, or any combination thereof.
  • E-Field sensors can be constructed by bio-compatible metal and dielectric materials.
  • E-field sensors can be designed to maximize sensitivity to capture electrical field change induced by vascular issues.
  • the E-Field sensor design adopts inter-digitated electrodes to augment the fringe electric field, thereby enhancing signal integrity, as any changes in occlusion disturb the fringe electric field, inducing a change in impedance. Through the application of a proprietary occlusion model, this impedance value can be correlated to the percentage of blockage, thus offering doctors and patients an insightful metric to gauge occlusion status and determine the necessity for medical intervention.
  • the E-Field sensors can be constructed with bio-compatible materials.
  • E-Field sensors can be a metallic compound suitable for PCB manufacturing.
  • E- Field sensors can be constructed with noble metals.
  • Noble metals can include platinum and gold.
  • E-Field sensors can be copper coated by gold plating, for example, electroless nickel immersion gold plating.
  • E-Field sensors comprise a dielectric layer.
  • the dielectric layer can be constructed with biocompatible polymers.
  • a sensor module comprises a sensor carrier.
  • a sensor carrier can comprise a shape memory alloy in the form of a strip 12 or in the form of a wire 13. In other embodiments, a sensor carrier can be made using a different alloy.
  • a sensor carrier can comprise a transducer array carrier structure 22. In some cases, a sensor carrier can be made in a different form.
  • Piezo element 10 can be attached to the sensor carrier.
  • E-Field sensor 11 can be attached to the sensor carrier. With reference to FIG. 1A and FIG. 2A, both piezo element 10 and E-field sensor 11 can be attached to the sensor carrier.
  • a sensor carrier can convey sensory data from the piezo element 10 or the E-Field sensor 11 to the computer module 1 via an interconnect 2.
  • the E-Field sensors are spaced across the sensor carrier. In certain embodiments, the E-Field sensors are spaced between the ultrasonic transducers in an array. In certain embodiments, the E-Field sensors are spaced between the ultrasonic transducers in individual sections for more localized measurements. In some cases, the E-Field sensors are spaced around the ultrasonic transducers in an array. In some cases, the E-Field sensors are spaced around the ultrasonic transducers in individual sections for more localized measurements. In some cases, E-Field sensors span the entire length of the sensor carrier and conduct a gross measurement on the entire vessel surface.
  • a sensor carrier is constructed with bio-compatible material.
  • the sensor carrier can be constructed with a noble metal conductor, such as but not limited to platinum and gold.
  • the sensor carrier can be constructed with a pure gold conductor.
  • the sensor carrier can comprise a pure gold conductor inside a bio-compatible insulator.
  • a biocompatible insulator can comprise liquid crystal polymer.
  • a bio-compatible insulator can comprise a polyimide or glass substrate.
  • the sensor carrier can comprise gold-coated copper trace materials.
  • the sensor carrier can comprise gold-coated copper trace materials applied to a laminate substrate.
  • the laminate substrate can comprise resin, polyimide, fiberglass, or any combination thereof, enclosed by a thick biocompatible thermoplastic elastomer sufficient to hermetically seal the sensor carrier.
  • the devices described herein can comprise a sensor module comprising one or more ultrasonic sensors configured to measure one or more vascular health signals, wherein said one or more ultrasonic sensors is arranged in a three-dimensional helical shape configuration; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • the devices described herein can comprise a sensor module comprising one or more electrical field sensors configured to measure one or more vascular health signals, wherein said one or more electrical field sensors is arranged in a three- dimensional helical shape configuration; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • the sensor carrier can comprise a helix-shaped structure.
  • the helix-shaped structure can comprise a three-dimensional helix-shaped structure.
  • ultrasound transducers can be arranged across the sensor carrier in a three-dimensional helix-shaped structure.
  • E-Field sensors can be arranged across the sensor carrier in a three-dimensional helix-shaped structure.
  • a helix-shaped structure can offer secure and robust attachment without constriction, thereby safeguarding against potential vessel damage while ensuring flexibility along the vessel axis.
  • the sensor carrier can comprise an approximately flattened polygon-shaped structure.
  • the sensor carrier can be elliptical, circular, rectangular, square, triangular, pentagonal, hexagonal, or another polygon structure.
  • ultrasound transducers can be arranged across the sensor carrier.
  • the ultrasound transducers are arranged side-by-side across the sensor carrier.
  • E-Field sensors can be arranged across the sensor carrier.
  • the E-Field sensors can be located on the part of the sensor carrier nearest to the interconnect.
  • the sensor carrier is constructed by flexible circuits which are electrically connected to the ultrasound sensors. In some cases, the sensor carrier is constructed by flexible circuits which are electrically connected to the E-field sensors. In some cases, the sensor carrier comprises post-implant adjustment capabilities. As a nonlimiting example, the sensor carrier can comprise a memory metal wire construction made of nitinol, which enables real-time adjustments of the sensor’s positioning, improving the accuracy and sensitivity of ultrasound measurements and accommodating vessels of varying sizes. In other embodiments, the design similarly enhance the device’s adaptability and functionality in monitoring vessels.
  • the implantable devices described herein comprise a three- dimensional helix.
  • the device can be implanted by invasive surgery.
  • the device can sit around the target vessel.
  • the three-dimensional helix surrounds the vessel.
  • the insertable devices described herein can be inserted by non- invasive surgery.
  • the devices described herein can be inserted via an injection tool.
  • the device can be inserted subcutaneously or intramuscularly. The device can sit adjacent to the target vessel.
  • the devices described herein are placed in substantially the same area regardless of whether the devices are implanted or inserted.
  • the devices described herein can comprise a sensor module comprising one or more ultrasonic sensors, wherein said sensor module is configured to detect a distance from said one or more ultrasonic sensors to a vessel surface and to adjust an angle between an ultrasound beam released from said one or more ultrasonic sensors and said vessel surface based at least in part on the distance from said one or more ultrasonic sensors to said vessel surface, and said one or more ultrasonic sensors is configured to measure one or more of vascular health signals of said vessel; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • adjusting an angle can comprise compensating for an angle between said ultrasound beam and said vessel surface.
  • the sensor module of the vascular monitoring devices described herein comprises an ultrasonic self-locating feature (not shown).
  • the self-locating feature can allow evaluation of the device’s angle relative to the vessel of interest. If the device is inserted or implanted approximately parallel, then the self-locating feature can identify the difference in angle between the intended and actual angle.
  • the angle of a device described herein can be determined by utilizing ultrasound imaging and an external probe during the insertion or implantation process or the device.
  • the ultrasound imaging and external ultrasonic probe can help to insert or implant the device parallel, or approximately parallel, to a vessel of interest using the hyperechoic location features 23 and 24.
  • the angle of a device described herein is determined by the device itself after insertion or implantation.
  • the ultrasonic self-locating feature can utilize various ultrasound techniques to identify the distance from an ultrasonic sensor in a sensor module to a vessel surface.
  • the ultrasonic self-locating feature can utilize various ultrasound techniques to identify the distance from each ultrasound element to the vessel surface.
  • the ultrasonic self-locating feature can utilize various ultrasound techniques to adjust an angle, or compensate for the angle, between an ultrasonic transmitted beam and a vessel surface. Examples of ultrasound techniques include, but are not limited to, B-mode, pulse echo, or time-of-flight measurement ultrasound.
  • Pulse echo and backscatter mode can comprise measuring the frequency content, attenuation, time behavior, diffusion properties of backscattered signals, statistical properties of backscattered signals, or any combination thereof.
  • pulse echo mode the same piezo element can be used to transmit and receive.
  • backscatter mode different elements can be used to transmit and receive respectively.
  • Signal statistical properties can include, but are not limited to, envelope statistics.
  • Envelope metrics can be measured using models such as, but not limited to, homodyned-K or Nakagami models.
  • Backscatter metrics can include but are not limited to, backscatter coefficients and their spectral properties, for example midband fit, spectral slope, and intercept.
  • B-mode can comprise generating a two-dimensional ultrasound image. Images can be formed through A- or B- mode ultrasound methodology and can be used to compute a 2- dimensional spatial map of the sensor’s position relative to the vessel using information obtained in the image. B-mode can comprise generating a two-dimensional ultrasound image by a series of ultrasound echoes. The ultrasound sensors can sense ultrasound echo signals. The amplitude of the echo signal that returns to the ultrasound sensor correlates to a brightness of a pixel. A collection of the dots can generate a two-dimensional image. In some cases, similar results can be attained by plane wave imaging.
  • Time-of-flight measurement can be used to measure distances.
  • the ultrasonic sensor can release a short, high-frequency sound pulse on a cyclical basis.
  • the sound frequency can be above the threshold of human hearing.
  • the distance to an object can be measured based on assuming a speed of sound, and measuring how long it takes for the ultrasound pulses to go to the object and back to the ultrasound sensor.
  • the devices described herein can use this measurement to determine the distance between the devices and a vessel.
  • the device can use a multitude of these measurements to judge distances between the device and more than one vessel. This technique can be used to create a distance map of surrounding vessels and vascular structure relative to the device.
  • time-of-flight measurement can be used to measure the speed of signal propagations upstream and downstream the flow of a certain medium to estimate total flow velocity.
  • ultrasound sensors can be used to estimate the time-of-flight measurement, and thus the total flow velocity, of the vessel to which they are attached.
  • the vessel is a cardiac vessel.
  • Adjusting the angle can be done by an electrically adjustable sensor carrier to facilitate postimplantation adjustments for customized, optimal health monitoring over prolonged periods of time without requiring alterations in the device’s positioning.
  • the angle of the device can be compensated for by altering the ultrasound transmitted pulses used for determining properties of a vessel of interest.
  • the ultrasound transmitted pulses can be adjusted by adjusting beam-forming sequences after insertion or implantation.
  • a plane wave can be transmitted using some or all of the elements of an array of ultrasound transducers.
  • the target vessel can automatically be segmented and the angle between the sensor and the vessel can be determined. Pulse transmit delays can be calculated based on this measured angle, and beam steering can be performed using delay and sum ultrasound beamforming to compensate for the angle.
  • a medical provider can measure vascular abnormalities including, but not limited to, occlusion, turbulent blood flow, irregular flow rates, abnormal pressure patterns, or any combination thereof.
  • vascular abnormalities including, but not limited to, occlusion, turbulent blood flow, irregular flow rates, abnormal pressure patterns, or any combination thereof.
  • a medical provider can also instruct the device to compensate for the angle of insertion or implantation of the device relative to the vessel of interest. This way, a medical provider can monitor a target vessel with properly aimed Doppler and ultrasound beams.
  • Manipulating beam-forming sequences can be done without being in physical contact with the devices described herein, for example with an external device such as a scanner or a reader.
  • Described herein are devices for monitoring vascular health in a subject comprising a sensor module comprising one or more ultrasonic sensors configured to measure one or more vascular health signals of said vessel, wherein said sensor module is configured to evaluate said device’s position relative to a vessel upon insertion of said device in said subject; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • the device comprises ultrasonic identifiable feature to guide the sensor positioning during and measure sensor position angle.
  • the device comprises an insertable device for monitoring vascular health.
  • the sensor module can be used to evaluate said device’s position and rotation.
  • the sensor module can be used to evaluate said device’s position and rotation during or after insertion.
  • imaging by an external ultrasound probe can be used to evaluate said device’s position after insertion.
  • the sensor module can comprise an ultrasonic positional identification feature.
  • the sensor module can evaluate a vascular monitoring device’s position.
  • an external ultrasonic probe can be used in conjunction with the sensor module to evaluate a vascular monitoring device’s position.
  • An external ultrasonic probe may identify and locate hyperechoic material features on the device allowing for positional and rotational understanding during insertion to aid a medical practitioner in correct placement relative to a target vessel. Placing the device parallel to the vessel axis can allow for accurate and reliable Doppler flow velocities.
  • the ultrasonic positional identification feature can be formulated by situating hyperechoic reflective material 23 and 24 at one or both ends of the insertable device, insertion tool, or any other embodiment of the devices, systems, and methods disclosed herein.
  • the ultrasonic positional identification feature can allow evaluation of the insertable device's position relative to the vessel of interest by utilizing an external ultrasound during the insertion process. Evaluation of the insertable device’s position can gauge if the device has been inserted parallel, or near parallel, to a vessel of interest. If the device is inserted approximately parallel, then the positional identification feature can help a medical practitioner identify the difference in position between the intended and actual position.
  • the tip of the ultrasonic positional identification feature can comprise hyperechoic material.
  • Hyperechoic material can be situated at one or more ends of the vascular health monitoring device.
  • the tip of the feature is sensitive to and reflective of ultrasound.
  • the tip can be used to determine the device’s position relative to a vessel.
  • the tip of the feature comprises a combination of hard and soft materials to effectively locate feature tips and determine geometry for orientation.
  • the tip can be used to calibrate the devices described herein by comparing an actual location of the device against the device's internal model of its spatial position. After calibration, the tip can be used to verify the position of a vascular health monitoring device by comparing an intended location against the actual location of the reflective tip.
  • the ultrasonic positional identification feature may facilitate the unfolding or unlocking features 25 of a vascular monitoring device by ensuring the insertable device is centered accurately after insertion or restricting the sensor's rotation along its axis.
  • the unfold features 25 can comprise a spring extension, a bistable metal flexure, additional methods of unfolding part of a vascular monitoring device, or a combination thereof.
  • the unfolding feature may facilitate accelerated scarring of the surrounding tissue to prevent adjustments in position and rotation. This unfolding feature can allow for an axial positional shift without a rotational positional shift, as the unfolding feature will fold or lock back into the original state when shifted along its axis to improve insertion as well as removal.
  • the device comprises a computer module with circuits for power management, data processing, and wireless signal communication.
  • the computer module augments the sensor module, comprising a blend of components including power regulation, rectifying and filtering linked with an array of sensors and transducers through a interconnect between computer module and sensor. This module can conduct wireless data transmission for efficient data exchanges.
  • the computer module can be comprised of a microcontroller processor and digital signal processor that oversees the signal collection, data relay, and energy reception tasks for uninterrupted operation.
  • the computer module can be a subdermal module.
  • the computer module can be an intramuscular module.
  • the computer module is implantable.
  • the computer module is insertable.
  • a computer module comprises an induction coil 3, a microprocessor 4, a communication antenna 5, an EMI shield material 6, a top layer of elastomeric coating 7, a bottom layer of elastomeric coating 8, and suture holes 9.
  • a computer module comprises an induction coil 3, a microprocessor 4, a communication antenna 5, an EMI shield material 6, a top layer of elastomeric coating 7, and a bottom layer of elastomeric coating 8.
  • the computer module encapsulates the circuits and features for reduction of thermal energy in the body. Thermal energy can be reduced by tethering the electronics away from the sensor deep in the body and increasing wireless power efficiency by moving the computer module to the subdermal surface of the skin.
  • induction coil 3 acts as a power transceiver.
  • the coil can utilize inductance-based or resonance-based wireless power harvesting to ensure a ceaseless power supply to the implanted sensor device for uninterrupted monitoring during a cardiovascular assessment.
  • Induction coil 3 can receive power from an electromagnetic radiated field source.
  • the power source can be external to the body.
  • microprocessor 4 houses a signal processor (not shown), data transceiver (not shown) and signal transceiver (not shown).
  • the signal processor can oversee the sensor measurements.
  • the signal processor can process and digitize the signals captured in the sensor module for effective transmission and subsequent analysis.
  • the signal transceiver can further digitize data to prepare it for wireless transmission to an external scanner.
  • the signal processor conducts a preliminary digitization step and the signal transceiver conducts a subsequent digitization step.
  • the signal processor is sufficient for digitization.
  • the signal transceiver is sufficient for digitization.
  • the signal processor digitizes ultrasound waveforms into a uniform format.
  • the signal processor digitizes ultrasound waveforms into a compressed or encoded format.
  • the signal transceiver digitizes the uniform format into a format that a processor, reader, scanner, computer, or any combination thereof could read.
  • the signal processor can process raw ultrasound waveforms received by the sensor module to: 1) extract quantitative ultrasound metrics such as individual spectral components and subsequent variable frequency information, signal statistical properties, time-of-flight measurements, attenuation, envelope metric, or backscatter metrics, or any combination thereof; 2) form one or more images based on the ultrasound waveforms; or 3) extract Doppler measurements.
  • Signal statistical properties can include, but are not limited to, envelope statistics.
  • Envelope metrics can be measured using models such as, but not limited to, homodyned-K or Nakagami models.
  • Backscatter metrics can include but are not limited to, backscatter coefficients and their spectral properties, for example midband fit, spectral slope, and intercept.
  • Images can be formed through A- or B- mode ultrasound methodology and can be used compute a 2-dimensional spatial map of the sensor’s position relative to the vessel using information obtained in the image. Images can be formed through plane wave ultrasound methodology.
  • the data transceiver communicates the processed data to an external reader.
  • the external reader can be used to receive sensory data from the computer module 1.
  • the external reader can be read by the patient and licensed healthcare professional.
  • the external reader is external to the body.
  • the devices described herein comprise a physical and electronic connection between the sensor module and the computer module.
  • the device described herein can comprise an electronic connection between the sensor module and the computer module.
  • the connection comprises a connecting tether.
  • the sensor module 15 and computer module 1 are connected via an interconnect 2.
  • the sensor module 20 and computer module 1 are connected via an interconnect 2.
  • the interconnect can be an interconnecting tether.
  • the interconnect can be a tether feature.
  • the interconnect can be a cable feature.
  • the sensory module and computer module are connected by fusing both modules into an integrated body.
  • the integrated body can expedite the scarring process and secure sensor orientation through an unfolding feature 25.
  • the unfolding feature 25 has a folded state and an unfolded state.
  • the unfolding feature 25 is held in its folded state in the body of the monitoring device when contained in an insertion tool.
  • the unfolding feature 25 can function when fully inserted into the body of the patient.
  • the unfolding feature 25 can function by, but is not limited to, the following: unfolding, unlatching, using a spring extension, using a bistable metal flexure, or any combination thereof to promote and accelerate tissue scarring around the unlatched feature.
  • the unfolding feature 25 can stabilize and solidify the position of the sensor in the body.
  • the unfolding feature 25 secures sensor orientation by stabilizing an angle between the sensor module and an adjacent vessel upon implantation or insertion of the device.
  • the devices described herein can fold and unfold when inserted or removed along one axis, so the folding feature is smooth and round when moving axially.
  • the folding feature can fold when moved along the insertion or removal axis but unfold or expand outwards when the movement is relaxed.
  • the interconnect functions via a near-field wireless connection, allowing the modules to communicate effectively while remaining physically separate.
  • the wireless connection can be through, but not limited to, Bluetooth or custom RF frequency.
  • the flexible device may have a sensor module, computer module, and interconnect as described above.
  • FIGS. 3A-3H depict exploded (FIG. 3A), perspective (FIGS. 3D, 3G-3H), top- down (FIGS. 3B-3C, 3E), and side (FIG. 3F) views of a flexible insertable monitoring device 100.
  • the device 100 can comprise transducer sensor body 102, positional stabilizer 104, air backing structure 106, one or more transducers 108, flexible interconnect printed circuit board 110, biocompatible elastomeric polymer 112, computer module 114, and computer module housing 116.
  • the biocompatible elastomeric polymer allows for a flexible interconnect.
  • polymer 112 and interconnect pcb 110 make up the interconnect between the sensor module and the computer module.
  • the number of transducers 108 can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more transducers.
  • the tail of the device can comprise the computer module 114 and computer module housing 116. There can be a strip connecting the tail and sensor module via a flexible circuit.
  • the entire device can be coated in biocompatible elastic polymer.
  • the tail may contain a rigid housing that the electronics are placed or molded into, and then the biocompatible elastic polymer can be then coated overtop of the tail housing, sensor, and flex strip. The entire sensor and tail can be kept within a maximum width.
  • the sensor can comprise an optional expandable feature which expands after insertion and aids in stabilization of position and minimization of scarring of tissue.
  • the backing for the transducers 108 can comprise an air backing layer 106 comprising air pockets. This can help to direct ultrasound energy out of the exposed face of the device 100.
  • the transducers 108 can be built on a substrate with air pockets to have the rear of the transducer rest against air while supported by its edges..
  • FIG. 3B shows the capture geometry 126 of the insertable device 100 that can be used when gripping the device by a forceps tool through an additional incision, as shown in FIG. 10F
  • FIG. 3C shows induction antenna 118, microcontroller 120, power and communication circuitry (e.g., chip antenna configuration) 122, the flexible interconnect 112, and the pointed tip of the sensor for tissue separation 128.
  • power and communication circuitry e.g., chip antenna configuration
  • FIG. 3F shows the tip of the sensor designed to be flush with a cartridge housing of an insertion tool for insertion ease into tissue 130.
  • FIGS. 3G-3H show open and closed folded versions, respectively, of the tail end of device 100.
  • Device 100 can comprise the compute unit 132 (e.g., the tail comprising the computer module 114 and the computer module housing 116), an induction antenna in an unfolded 134 or folded 136 state, a biocompatible flexible polymer substrate 138 backing the antenna, and an induction antenna coil 140.
  • the antenna can be flexible.
  • the antenna 134 can be wrapped around the housing 116 in un-deploy ed form when in an insertion tool cartridge. The antenna can then unfold after insertion. In some cases, the insertion tool may have features to unfold it. In some cases, the antenna is held in compression and is biased to unfold naturally once released from the compression of the cartridge.
  • FIG. 31 shows an external version of the entirety of monitoring device 100 as a non-exploded form of FIG. 3A.
  • FIG. 3 J shows internal components of an insertable monitoring device.
  • the device can be device 15, 20, 100, or any other insertable monitoring devices described herein.
  • FIG. 3 J shows ultrasonic system control unit 142, driving and sensing circuit 144, power and management circuit 146, antenna 148, battery 150, control unit enclosure base 152, and control unit enclosure lid 154.
  • the system comprises a vascular health monitoring device as described herein and an external reader device equipped with features that supply power, aid in data processing, and allow for cloud uploads.
  • the reader can receive vascular health data comprising vascular health signals, electrical field signals, or both from the vascular health monitoring device.
  • the vascular health signals can be derived from ultrasound signals.
  • a signal processing system that can process ultrasonic data, extract metrics (e.g., blood flow velocity, vessel diameter, blood pressure, flow rate), apply predictive data models to identify early signs of vascular occlusion or stenosis, and transmit the data wirelessly to a mobile app for real-time display and/or cloud storage.
  • the system can connect wirelessly to a mobile app and/or cloud platform, enabling continuous data transmission and analysis, with integration capabilities for Electronic Health Records (EHR) to allow seamless data sharing between patients and healthcare providers.
  • EHR Electronic Health Records
  • the system can comprise a low-power electronics system that can drive and acquire data from the high density transducer matrix.
  • the system can enable low power application while maintaining high accuracy measurement.
  • the power management unit can include options for charging and integration with energy -harvesting technologies to power the device over long periods.
  • the system can comprise a software ecosystem paired with cloud infrastructure to accumulate, secure, and disseminate insights into vascular health to accredited medical personnel.
  • the uploaded sensor data whether ultrasound, electrical field, both, or any other type of sensor data, is processed to extract quantitative parameters such as envelope statistical properties, attenuation, scattering parameters, time of flights, field strength, or any combination thereof, to delineate vascular health condition.
  • a baseline sensor signal is recorded after placing an implant, wherein the signal change over a monitoring period is used to detect vascular condition change.
  • the devices described herein wirelessly communicate with a mobile device and app, where the processed data is visualized in a user-friendly interface for both patients and clinicians.
  • the app can integrate with cloud infrastructure for data storage and additional post processing, allowing for detailed health trend analysis and real-time alerts. It may also support Electronic Health Record (EHR) integration, facilitating seamless data sharing with healthcare systems.
  • EHR Electronic Health Record
  • the system can comprise an advanced electronics system that can drive and acquire data from the high density ultrasonic transducer matrix.
  • the electronics system can remain energy-efficient while maintaining high accuracy.
  • Wireless charging or battery integration can be used for a simple and user-friendly operation, encouraging compliance with regular use.
  • the vascular monitoring device can comprise a sensor module comprising one or more ultrasonic sensors or one or more electrical field sensors, wherein said one or more ultrasonic sensors is configured to measure one or more vascular health signals and wherein said one or more electrical field sensors is configured to measure an electrical field signal related to a vessel; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals and said electrical field signal; wherein said sensor module and said computer module are operably linked to each other.
  • the vascular health monitoring device can comprise a sensor module comprising one or more ultrasonic sensors, wherein said sensor module is configured to detect a distance from said one or more ultrasonic sensors to a vessel surface and to adjust an angle, or compensate for the angle, between said one or more ultrasonic sensors and said vessel surface based at least in part on the distance from said one or more ultrasonic sensors to said vessel surface, and said one or more ultrasonic sensors is configured to measure one or more of vascular health signals of said vessel; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • the vascular health monitoring device can comprise a sensor module comprising one or more ultrasonic sensors configured to measure one or more vascular health signals, wherein said one or more ultrasonic sensors is arranged in a three- dimensional helical shape configuration; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • the vascular health monitoring device can comprise a sensor module comprising one or more electrical field sensors configured to measure one or more of vascular health signals, wherein said one or more electrical field sensors is arranged in a three-dimensional helical shape configuration; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • the vascular health monitoring device can comprise a sensor module comprising one or more ultrasonic sensors configured to measure one or more vascular health signals of said vessel, wherein said sensor module is configured to evaluate said device’s position relative to a vessel upon insertion of said device in said subject; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals; wherein said sensor module and said computer module is operably linked to each other.
  • the system can comprise a reader, wherein the reader can receive one or more vascular health data points from the vascular health monitoring device.
  • the reader can receive vascular health data and signals from the monitoring device via internet connection.
  • the reader can receive vascular health data and signals from the monitoring device via cloud infrastructure.
  • the vascular health monitoring device can transmit signals to the reader, the cloud infrastructure, or both.
  • the reader can communicate with the cloud infrastructure via internal connection.
  • Cloud infrastructure can be used to share monitoring results through one or more of a clinical dashboard, a web-based interface, or an app-based interface accessible to the patient, a medical practitioner, or both.
  • the scanner can comprise an external scanner that is external to the body.
  • the scanner can be worn on the body as a wearable device.
  • the scanner can be a free-standing scanner that is not worn on the body.
  • the scanner can be configured to communicate with a vascular health monitoring device as described herein through one or more of: a Bluetooth wireless connection, a custom RF transceiver, or an induction coil.
  • the scanner can be battery powered.
  • the scanner can be USB rechargeable.
  • the scanner can be charged via wire or wirelessly.
  • the scanner can be charged with a docking system.
  • the scanner handles communication to and from the monitoring device.
  • the scanner can act as the external reader.
  • scanner uses the electrical PCB 46 to direct communication.
  • the scanner’s inner coil 43 may also be used alternately or in conjunction with the outer coil 42 to communicate wirelessly to the computer module of a monitoring device by using a proprietary communication protocol.
  • the scanner communicates to the device through, but not limited to, Bluetooth, custom RF frequency, or encoded information sent through the power delivery system.
  • information can be sent between induction coils in the scanner and the monitoring device.
  • the scanner acts as a data bridge between the sensor and the patient’s terminal by collecting vascular signals, encoding the signal data, and sending this information by Bluetooth or RF frequency.
  • the system can comprise an external power source that is external to the body.
  • the external power source can be the same device as the scanner device.
  • the external power source can be a different device than the scanner device.
  • the external power source is the scanner.
  • the scanner can be configured to supply power to the vascular health monitoring devices described herein.
  • the power delivery device can be a scanner.
  • the scanner can comprise a scanner ring body 40, a scanner handle body 41, an outer coil 42, an inner coil 43, and operational button 44, an indicator beam 45, an electrical printed circuit board (PCB) 46, a USB connector port 47, and a battery holder 48.
  • the scanner can be used to interact with a device disclosed herein.
  • the scanner can be used in an at-home setting or in a medical setting.
  • the scanner can be used by the patient or by a licensed medical practitioner.
  • the user can hold the scanner by the scanner handle body 41.
  • the user can aim the scanner ring body 40 above the skin where the monitoring device was inserted or implanted.
  • the user can operate the scanner by pressing operational button 44 to transfer power to the monitoring device or to communicate with the monitoring device.
  • the user is notified of the communication status and power of the scanner by lights on the indicator beam 45.
  • the scanner can operate as a power delivery device to the computer module of a monitoring device.
  • the scanner can use the electrical PCB 46 to direct power transmissions.
  • the scanner uses outer coil 42.
  • the scanner uses inner coil 43.
  • the scanner uses both outer coil 42 and inner coil 43.
  • the scanner may use the outer coil 42, the inner coil 43, or a combination of, to amplify and focus the magnetic flux of a transformer.
  • the transformer can be separate.
  • the transformer can be part of the scanner.
  • the scanner can deliver power to the computer module of a monitoring device through wireless power based upon, but not limited to, induction methods, resonance-based methods, or both.
  • the scanner is battery powered and uses battery holder 48.
  • the scanner is USB rechargeable and has a USB connector port 47.
  • the scanner can be both battery powered and USB rechargeable.
  • the scanner can be charged via wire or wirelessly.
  • the scanner can be charged with a docking system.
  • the system comprises an insertion tool.
  • the vascular monitoring device can be inserted via an insertion tool.
  • the insertion tool comprises an insertion plunger 30, finger grasp feature 31, a device loading area 32, a device insertion finger 33, and hyperechoic locating features 34 and 35.
  • Licensed medical personnel can handle the insertion tool.
  • a medical practitioner can hold the insertion tool at the finger grasp feature 31 with forefinger and middle finger while having his or her thumb on the insertion plunger 30.
  • a medical practitioner can insert a vascular monitoring device into the device loading area 32 via the device insertion finger 33.
  • the insertion tool can come preloaded and configured with a vascular monitoring device as described herein, such that a medical practitioner can open up a packet with the insertion tool and be able to use it without loading a vascular monitoring device.
  • the devices described herein can fold and unfold when inserted or removed along one axis, so the folding feature is smooth and round when moving axially.
  • the folding feature can fold when moved along the insertion or removal axis but unfold or expand outwards when the movement is relaxed.
  • the insertion tool can comprise an ultrasonic positional identification feature.
  • the ultrasonic positional identification feature can be formulated by situating hyperechoic locating features 34 and 35 at one or both ends of the insertion tool.
  • the ultrasonic positional identification feature can allow evaluation of the insertion tool's position relative to the vessel of interest by utilizing an ultrasound and an external probe. Evaluation of the insertion tool’s position can improve the ability to insert a device as described herein parallel to a vessel of interest. Evaluation of the insertion tool’s position can improve the ability to insert a device as described herein approximately parallel to a vessel of interest. If the device is inserted approximately parallel, then the positional identification feature can identify the difference in position between the intended and actual position.
  • the ultrasonic positional identification feature can allow evaluation of the insertable device's position relative to the vessel of interest by utilizing external ultrasound.
  • the tip of the feature is sensitive and reflective to ultrasound.
  • the tip of the feature is made up of a combination of hard and soft materials to effectively locate feature tips and determine geometry for orientation.
  • the identification features on the tool can be used for positional aid and locating of the proposed insertion area.
  • the identification features on the sensor are utilized for position verification and, but not limited to, device calibration of positional location against theoretical self-located position.
  • the tip can be used to calibrate the devices described herein by comparing an actual location of the device against an intended location by determining where the tip is reflecting the ultrasound.
  • the tip can be used to determine the insertion tool’s position relative to a vessel of interest.
  • the insertable devices described herein can be inserted by non- invasive surgery.
  • the devices described herein can be inserted via an injection tool.
  • the device can be inserted subcutaneously or intramuscularly. The device can be injected to sit adjacent to the target vessel.
  • FIGS. 5A-5H depicts perspective (FIGS. 5A-5B, 5C, 5E) and side (FIGS. 5D, 5F-5H) views of an alternate insertion tool 200.
  • FIGS. 5A-5B show a vascular monitoring device 202 (e.g., device 100) that is then inserted into the insertion device 200.
  • FIGS. 5A-5B show sensor module 204.
  • compute unit/tail 206 similar to 132
  • a structural fin 208 that acts as a positional immobilizer
  • capture geometry 210 in a structural frame for connecting to the insertion tool body. All of 202-210 make up the cartridge contents 212 which are inserted into the insertion tool 200.
  • the interconnect may be longer and thus the capture geometry and structural fin may not rest against the tail and thus may avoid moving the tail when the insertion device is withdrawn and the capture geometry 210 is dissociated from the monitoring device
  • the body of the handheld tool 200 can mate with the structural support beam (capture geometry 210) inside the cartridge which holds the beam still, subsequently holding the sensor in position as the cartridge retracts.
  • FIGS. 5C-5E show insertion device 200 comprising cartridge needle 214, ratcheting teeth 216, grip features 218 for a finger hold, a rotational ratchet mechanism 220 in-axis, and sensor leaded in the cartridge 222 (e.g., 202 as part of 212).
  • FIGS. 5F-5H show insertion device 200 comprising cartridge body 224, slotted needle tip 226, sharp edge feature (e.g., the needle point of the cartridge) 228, and ratcheting teeth 230.
  • the slotted needle tip 226 allows the cartridge to fully retract through the insertion device 200 and the structural fin 208 to pass through to the insertion device body.
  • These ratcheting teeth 230 are the teeth for the ratchet feature 216 to engage with.
  • the device 200 can comprise a sharp tip which acts as a tissue deflector.
  • the features of device 200 can be contained in a cylindrical form.
  • the unsheathing of the cartridge can be rotational-based as rotational ratchet mechanism 220 rotates, moving the cartridge back and forth. There can be divots for fingers to rest for a comfortable hand feel.
  • the cartridge can be retracted around the monitoring device to keep its position intact and precise. This way, the sensor position can remain deployed.
  • the insertion tool can be inline and held like a pencil.
  • the cartridge can be housed in the insertion device assembly and comprise a tube with a needle-like point which holds the monitoring device.
  • the cartridge can also hold a structural element - structural fin 208 can be used to hold the monitoring device in position from inside the cartridge while the cartridge’s outer sheath is pulled back.
  • the user may insert the cartridge into the handheld insertion device or the handheld insertion device may be pre-packaged with the cartridge and sensor inside it.
  • the surgeon can push the insertion device subcutaneously, plunge it to the desired depth and angle by utilizing duplex ultrasound (b-mode Doppler as described herein), and once positioned the surgeon can rotate the handle feature to begin retracting the housing around the sensor. This is further discussed in methods below.
  • FIGS. 6A-6B depicts perspective (FIG. 6A) and top-down (FIG. 6B) views of an alternate insertion tool 300.
  • Insertion tool 300 can comprise the insertion tool body 302, cartridge 304, rotational ratcheting mechanism off-axis 306, and a release mechanism for the ratchet teeth 308. Pressing this release mechanism 308 switch releases the ratchet 306 and the user can then pull the cartridge by hand to accelerate the removal of the cartridge after delicate positional deployment of the sensor.
  • Insertion tool 300 can comprise a dial that is placed tangentially to the cylindrical body. This dial may control the retraction of the housing. There may be a button or switch placed on the device body which releases the ratchet mechanism for manual control if the user wishes to pull the cartridge by hand or reseat the cartridge position during the insertion process.
  • FIGS. 7A-7F depict perspective (FIGS. 7A-7B, 7D-7E) and side (FIGS. 7C, 7F) views of an alternate insertion tool 400.
  • insertion tool 400 can comprise the insertion tool body 402, the sensor cartridge 404, a threaded retainer cap 406, an ejection rod 408, a trigger-based ratchet mechanism 410, and ratcheting teeth 412 which engage with the trigger 410.
  • insertion tool 400 can comprise the sensor cartridge 404, sensor unit 414 (e.g., a sensor unit as in insertion device 100), and retaining feature 416. A user can hold at the diagonal grip.
  • the sensor cartridge 404 can be replaceable.
  • the device 400 may come in different cartridges, one for the sensor and one for the tail, and during each insertion step the cartridge can be loaded and screwed on using the threaded retainer cap 406, which is locked to the cartridge housing.
  • the ejection rod 408 can be a toothed rod that travels the length of the insertion tool 400 and rests on the rear of the cartridge. The rod 408 can eject the cartridge contents through the needle, thereby pushing the sensor through the cartridge.
  • the retaining feature edge 416 can block the monitoring device (e.g., device 100) from being pushed back inside the sheathing cartridge.
  • the "assembled" or “loaded cartridge” state as shown in FIGS. 7D-7F may not have exposed geometry that can cause friction, tearing, or tissue buildup on the tip during insertion, allowing for a low friction insertion and reduced scarring. This may also decrease clogging or jamming of the insertion tool opening.
  • FIGS. 8A-8C depict top-down (FIG. 8A), side (FIG. 8B), and perspective (FIG. 5C) views of an alternate insertion tool 500.
  • Insertion tool 500 can comprise insertion tool body 502, cartridge 504, housing body 506, advancing trigger 508, thumb rest 510, needlelike cartridge tip 512, and ratcheting teeth in cartridge 514.
  • the cartridge can be the same as described in insertion tools 200-400.
  • the handheld can be symmetrical to allow for ambidextrous holding.
  • a finger can be wrapped around the knob (advancing trigger 508) for control of cartridge movement.
  • the advancing trigger can be a knob which traverses axially along the barrel of the cartridge. It can be spring loaded to return to position and engage the teeth of the cartridge to advance the retraction of the cartridge once the tool has been positioned. This knob 508 may also be turned or pulled vertically to unlock the latching mechanism and allow for free movement of the cartridge for easy manual retraction after the sensor is deployed.
  • FIG. 11 depicts a flow chart of an example system for monitoring a medical condition using devices disclosed herein.
  • the flow chart is divided into a clinical side 70 and a patient side 71.
  • the implanted or inserted monitoring device can act as a biosensor device 50 that can communicate via RF wireless communication 51 to a scanner tool 52, which in turns communicates via Bluetooth 53 to a patient terminal 54, which communicates to a Cloud backend 55 through the internet 56, and ends up in a clinical dashboard 57.
  • a clinician can then send sensor configuration data back to the biosensor by sending information from the clinical dashboard 57 to the Cloud backend 55 through the internet 56 to arrive at the patient terminal 54, which communicates with the scanner tool 52 via Bluetooth 53, and the scanner tool communicates with the biosensor 50 via RF wireless communication 51.
  • Both the patient and clinician can access communicated information via tablet 58, desktop computer 59, mobile phone 60, or web browser 61.
  • the patient terminal 54 can act as a hub for the patient’s access via tablet 58, desktop computer 59, mobile phone 60, or web browser 61, or any combination thereof.
  • the clinical dashboard 57 can act as a hub for a medical practitioner’s access via tablet 58, desktop computer 59, mobile phone 60, or web browser 61, or any combination thereof.
  • the medical practitioner can access the clinical dashboard 57 from any distance away from the patient, such that the medical practitioner can view biosensor results in the clinical setting while the patient is at home.
  • the medical practitioner can also view biosensor results while the patient is at the clinic in proximity to the medical practitioner.
  • the communication methods between each step are not limited to the ones disclosed above.
  • the scanner can transfer data through a mobile device (terminal) to the cloud. In some cases, the scanner can directly transfer from scanner data to the cloud (public or private) or local network.
  • the biosensor device 50 can comprise a vascular monitoring device as described herein.
  • the vascular monitoring device can be insertable or implantable.
  • the vascular monitoring device can be powered by the scanner 52.
  • Signals from the biosensor device 50 can be collected and digitized by the scanner 52 or digitized in the computer module of the device and sent wirelessly to the scanner for collection. Subsequently, this digitized data may be uploaded to a patient’s dashboard 54 and then transferred to a cloud infrastructure 55 for further analysis. Insights derived from the cloud-based analysis can then be shared with the patient and authorized healthcare providers through a clinical dashboard 57 or other webbased 61 or app-based interface.
  • the flow of data can be bidirectional between all links of the system, allowing for the clinical dashboard 57 to configure or modify the patient's dashboard 54 or the biosensor 50 indirectly.
  • data can be saved at the time of implant.
  • Calibration data for the angle of the devices disclosed herein can be saved at the time of implant.
  • the devices and systems described herein can comprise a calibration mode where the angle at which the device is implanted or inserted is recorded.
  • vascular health monitoring device comprising a sensor module comprising one or more ultrasonic sensors and one or more electrical field sensors, wherein said one or more ultrasonic sensors is configured to measure one or more vascular health signals and wherein said one or more electrical field sensors is configured to measure an electrical field signal related to a vessel; and a computer module comprising a signal processor, wherein said signal processor is configured to receive said one or more vascular health signals and said electrical field signal; wherein said sensor module and said computer module are operably linked to each other; b) collecting and analyzing one or more data points comprising said one or more vascular health signals and said electrical field signal; and c) transmitting said analyzed one or more data points to a processor. In some cases, this data is then processed to yield insights into vascular conditions, which are securely distributed to both patients and authorized healthcare providers.
  • FIGS. 10A-10F show a series of snapshots of a method for inserting an insertable monitoring device as described herein using one of insertion devices 200-500.
  • the method can use an insertion device 602 (e.g., devices 200-500) for inserting a monitoring device, which is inserted relative to skin 604 and fascia layer 606.
  • the insertion tool 602 can be loaded with the cartridge which includes the monitoring device and stabilizer. An incision can be made and the device can be inserted under the skin. The fascia muscle layer may or may not be punctured.
  • the rotatable (assuming 218 of device 200) or otherwise activatable section (of device 300-500) 608 can be activated to push the sensor module 610 out of the insertion device 602.
  • the cartridge (outer sheathing) is retracted away from the monitoring device and pulled back while the stabilizer can hold the monitoring device in position.
  • pulling back the outer sheathing can increase positional stability in comparison to pushing the device out of the nozzle into place so that the device remains in the ideal inserted position. If it had been pushed out, it may end up "swimming" or rotating out of the desired position.
  • the stabilizer can be disconnected with a button allowing the entire cartridge to be removed.
  • the insertion device can then be withdrawn from the skin along with the remnants of the cartridge and structural frame, leaving the sensor module 610 in the skin 604 but above the fascia layer 606 and the computer module 612 and substantial part of the interconnect outside of the skin 604.
  • the insertion tool can be discarded, the stabilizer can be discarded and the tail can be draped on the skin.
  • the tail and interconnect can be pushed into the incision just under the skin, as shown in FIG. 10E, using standard surgical tools (e.g., forceps). Alternatively, the tail and interconnect can be loaded into the insertion tool for a second round of insertion or simultaneously with the original insertion.
  • the second option can be to cut another incision upstream in order to grab and pull the tail through via forceps 614 that grab onto the capture geometry 126, which while being rounded can also have a divot or indentation for forceps to grab.
  • the senor module and computer module may be integrated as one device, and this integrated form factor may be inserted as directed above without flexible interconnect or tail computer module insertion steps.
  • vascular health monitoring devices comprising providing a vascular health monitoring device as described herein, collecting one or more data points comprising said one or more vascular health signals and said one or more of electrical field signals using said vascular health monitoring device; analyzing said one or more data points using said device; and transmitting said analyzed one or more data points to a processor.
  • vascular health monitoring system as described herein, collecting one or more data points comprising said one or more vascular health signals and said one or more of electrical field signals using said vascular health monitoring device; analyzing said one or more data points using said device; and transmitting said analyzed one or more data points to a processor.
  • a processor is external to the body.
  • the processor can be a scanner.
  • the processor can be the same scanner as described above, wherein the scanner comprises power functions and receipt of data from the devices described herein.
  • the processor can be a cloud processor, computer, or other information processing technology.
  • the methods comprise managing implantable or insertable vascular sensing devices for vascular health monitoring.
  • the method comprises implanting or inserting a vascular monitoring device as described herein into a patient.
  • the method involves positioning the sensor device within the patient's body, powering the sensors, and collecting and transmitting the sensor data to an external reader and cloud infrastructure.
  • the method can comprise positioning the vascular health monitoring device’s sensor module close to the target vessel for diagnosis.
  • the methods comprise collecting a variety of data from raw ultrasound waveforms that are sensed by the ultrasonic sensors.
  • the methods comprise collecting a variety of data from the electrical field sensors.
  • Data can be collected to gauge vascular health and health of the target vessel, or in a nearby vessel if the sensor is not positioned on the vessel, to which the vascular monitoring device is affixed.
  • Vascular health can be judged based on the thickness of the vessel, the vessel’s ability to conduct blood flow, and other metrics. Multiple techniques can be used to collect a variety of signals to determine vascular health.
  • collecting vascular health signals can comprise pulse echo mode.
  • Pulse echo mode can comprise measuring a frequency content, an attenuation, a time behavior, a plurality of diffusion properties of backscattered signals, a plurality of statistical properties of backscattered signals, or any combination thereof of an ultrasonic wave.
  • Signal statistical properties can include, but are not limited to, envelope statistics.
  • Envelope metrics can be measured using models such as, but not limited to, homodyned-K or Nakagami models.
  • Backscatter metrics can include but are not limited to, backscatter coefficients and their spectral properties, for example midband fit, spectral slope, and intercept.
  • collecting vascular health signals can comprise B-mode.
  • B-mode can comprise generating a two-dimensional ultrasound image. Images can be formed through A- or B- mode ultrasound methodology and can be used compute a 2-dimensional spatial map of the sensor’s position relative to the vessel using information obtained in the image.
  • B- mode can comprise generating a two-dimensional ultrasound image by computing a series of ultrasound echoes.
  • the ultrasound sensors can sense ultrasound echo signals. The amplitude of the echo signal that returns to the ultrasound sensor correlates to a brightness of a dot. A collection of the dots can generate a two-dimensional image. Plane wave imaging can also be used to generate a two-dimensional image.
  • collecting vascular health signals can comprise time-of-flight measurement.
  • Time-of-flight measurement can be used to measure distances.
  • the ultrasonic sensor can release a short, high-frequency sound pulse on a cyclical basis. The sound can be above the threshold of human hearing in frequency.
  • the distance to an object can be measured based on assuming or measuring a speed of sound and measuring how long it takes for the ultrasound pulses to go to the object and back to the ultrasound sensor.
  • the devices described herein can use this measurement to determine the distance between the devices and a vessel. The device can use a multitude of these measurements to judge distances between the device and more than one vessel. This technique can be used to create a distance map of surrounding vessels and vascular structure relative to the device.
  • time-of-flight measurement can be used to measure the speed of signal propagations upstream and downstream the flow of a certain medium to estimate total flow velocity.
  • ultrasound sensors can be used to estimate the time-of-flight measurement, and thus the total flow velocity, of the vessel to which they are attached.
  • the vessel is a cardiac vessel.
  • Doppler measurements can also be based on other types of ultrasound measurements.
  • analyzing vascular health signals can comprise digitizing the signals into a uniform format.
  • the method comprises digitizing measurements of ultrasonic waveforms.
  • the computer module of the vascular health monitoring device digitizes signals into a uniform format.
  • the uniform format can be a format readable to the computer module.
  • the uniform format can be a format readable to other devices, for example external devices not limited to computers, processors, readers, or any combination thereof.
  • the methods can further comprise powering a vascular health monitoring device.
  • the device can be powered via an external power source that is external to the body.
  • the external power source is a scanner.
  • the scanner can be configured to supply power to the vascular health monitoring devices described herein.
  • the scanner can operate as a power delivery device to the computer module of a monitoring device.
  • the scanner uses the electrical PCB to direct power transmissions.
  • the scanner uses an outer coil.
  • the scanner uses an inner coil.
  • the scanner uses both outer coil and inner coil.
  • the scanner may use an outer coil, an inner coil, or a combination thereof, to amplify and focus the magnetic flux of a transformer.
  • the transformer can be separate.
  • the transformer can be part of the scanner.
  • the scanner can deliver power to the computer module of a monitoring device through wireless power based upon, but not limited to, induction methods, resonance-based methods, or both.
  • the methods described herein can further comprise transmitting data points derived from vascular health signals and electrical field signals.
  • the data points can be transmitted by the vascular health monitoring device.
  • the data points can be transmitted by the computer module of the device.
  • the data points can be transmitted by the data transceiver in the computer module of the device.
  • the data can be transmitted to a reader.
  • the reader can be an external reader that is external to the body.
  • the reader can be a scanner, computer, or other electronic device.
  • the data can be transmitted directly to a computer, phone, or other electronic device directly accessible to a patient or medical practitioner, bypassing the scanner.
  • the methods comprise interpreting the transmitted data points.
  • interpreting can comprise combining data points to generate trends in the data points, including but not limited to trend lines, bar graphs, linear graphs, other graphical representations.
  • interpreting can comprise transforming coded data legible by a computer software and transmitted by a scanner, reader, or vascular health device, or any combination thereof, into something legible by a human that includes words and numbers.
  • interpreting can comprise generating sufficient information for a medical practitioner to create a diagnosis.
  • interpreting can be done by a computer software, reader software, monitoring device, or other processor, or any combination thereof.
  • a human can manually interpret the transmitted data points.
  • the methods further comprise generating a report for a health professional based on the interpretation of the transmitted data points.
  • the report can consist of words, numbers, trends, recommended diagnosis, and other medically relevant considerations, or any combination thereof.
  • the report can be delivered first to the medical practitioner, then to the patient; first to the patient, then to the medical practitioner; or simultaneously to both the medical practitioner and the patient.
  • the data model may be a statistical model, a non-AI/ML model, or an AI/ML model.
  • range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
  • determining means determining if an element is present or not (for example, detection). These terms can include quantitative, qualitative or quantitative and qualitative determinations. Assessing can be relative or absolute.
  • ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof.
  • Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited.
  • Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers, and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result.
  • the term “about” or “approximately” may mean within an acceptable error range for the particular value, which will depend in part on how the value is measured or determined, e.g., the limitations of the measurement system.
  • the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.
  • “about” may mean within 1 or more than 1 standard deviation, per the practice in the art.
  • “about” may mean a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value.
  • the term “about” a number refers to that number plus or minus 10% of that number.
  • the term “about” a range refers to that range minus 10% of its lowest value and plus 10% of its greatest value. Where particular values are described in the application and claims, unless otherwise stated the term “about” meaning within an acceptable error range for the particular value may be assumed.
  • the terms “external reader” and “scanner” are interchangeable.

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Abstract

L'invention concerne des dispositifs, des systèmes et des procédés de surveillance d'un état médical par l'intermédiaire d'un dispositif implantable ou insérable. Dans certains cas, le dispositif comprend un module capteur doté de transducteurs ultrasonores et de capteurs de champ électrique montés sur un support de capteurs réglable. Dans certains cas, le dispositif comprend un module informatique doté de circuits pour la gestion de puissance, le traitement de données et la réduction d'énergie thermique. Dans certains cas, le système comprend un moyen d'interaction avec un scanner externe pour un transfert d'énergie, une communication par l'intermédiaire d'une infrastructure en nuage, ainsi qu'une analyse de données et une accessibilité aux données améliorées pour les patients et les prestataires de soins de santé.
PCT/US2024/054804 2023-11-08 2024-11-06 Procédés, systèmes et dispositifs de surveillance de la santé vasculaire par l'intermédiaire d'un dispositif implantable/insérable Pending WO2025101666A1 (fr)

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US20170331474A1 (en) * 2015-09-29 2017-11-16 Beijing University Of Technology An Interdigitated Capacitive Proximity Sensor with Varied Space Electrode Structure
US20170332919A1 (en) * 2014-09-12 2017-11-23 Vanderbilt University Device and Method for Hemorrhage Detection and Guided Resuscitation and Applications of Same
WO2017198867A1 (fr) * 2016-05-20 2017-11-23 Koninklijke Philips N.V. Dispositifs et procédés de détermination de la vitesse des ondes de pouls sur la base des changements de diamètre du vaisseau
US20180336970A1 (en) * 2017-05-19 2018-11-22 Cardiac Pacemakers, Inc. Systems and methods for assessing the health status of a patient
WO2020044261A1 (fr) * 2018-08-28 2020-03-05 Access For Life Inc. Méthode et dispositif d'accès vasculaire
US20200253583A1 (en) * 2017-05-31 2020-08-13 Foundry Innovation and Research 1, Ltd. Implantable Ultrasonic Vascular Sensor
US20200289196A1 (en) * 2017-11-30 2020-09-17 Alleviant Medical, Inc. Transcatheter device for interatrial anastomosis
US20230329640A1 (en) * 2016-12-16 2023-10-19 Zoll Medical Corporation Electrode falloff detection

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150099942A1 (en) * 2013-10-04 2015-04-09 Volcano Corporation Vascular securement catheter with imaging
US20170332919A1 (en) * 2014-09-12 2017-11-23 Vanderbilt University Device and Method for Hemorrhage Detection and Guided Resuscitation and Applications of Same
US20170331474A1 (en) * 2015-09-29 2017-11-16 Beijing University Of Technology An Interdigitated Capacitive Proximity Sensor with Varied Space Electrode Structure
WO2017198867A1 (fr) * 2016-05-20 2017-11-23 Koninklijke Philips N.V. Dispositifs et procédés de détermination de la vitesse des ondes de pouls sur la base des changements de diamètre du vaisseau
US20230329640A1 (en) * 2016-12-16 2023-10-19 Zoll Medical Corporation Electrode falloff detection
US20180336970A1 (en) * 2017-05-19 2018-11-22 Cardiac Pacemakers, Inc. Systems and methods for assessing the health status of a patient
US20200253583A1 (en) * 2017-05-31 2020-08-13 Foundry Innovation and Research 1, Ltd. Implantable Ultrasonic Vascular Sensor
US20200289196A1 (en) * 2017-11-30 2020-09-17 Alleviant Medical, Inc. Transcatheter device for interatrial anastomosis
WO2020044261A1 (fr) * 2018-08-28 2020-03-05 Access For Life Inc. Méthode et dispositif d'accès vasculaire

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