DIAGNOSTIC ULTRASOUND MONITORING SYSTEM AND METHOD
20230093482 · 2023-03-23
Inventors
- Sergei Koptenko (Mississauga, CA)
- Thomas Hayes (Allison Park, PA, US)
- Matthew Lyon (North Augusta, SC, US)
Cpc classification
A61B8/485
HUMAN NECESSITIES
A61H2230/255
HUMAN NECESSITIES
A61N5/1049
HUMAN NECESSITIES
A61B8/5246
HUMAN NECESSITIES
A61B8/4477
HUMAN NECESSITIES
A61B8/4281
HUMAN NECESSITIES
A61H31/00
HUMAN NECESSITIES
A61B8/462
HUMAN NECESSITIES
A61B5/0024
HUMAN NECESSITIES
A61B8/4416
HUMAN NECESSITIES
A61B8/4245
HUMAN NECESSITIES
A61B5/01
HUMAN NECESSITIES
A61B8/4227
HUMAN NECESSITIES
International classification
A61B8/00
HUMAN NECESSITIES
A61H31/00
HUMAN NECESSITIES
Abstract
A distributed patient monitoring system comprises at least one standalone portable ultrasound imaging unit configured to be fixed to a stable position against the skin on a patient's body and capable of prolonged ultrasound data acquisition, including an ultrasound imaging array, transmit-receive circuitry, a beamformer, backend signal and image processing subsystem, power and communication subsystems, and a monitoring workstation connected to each standalone portable ultrasound imaging unit configured to request and receive ultrasound imaging information from each standalone portable ultrasound imaging unit, and configured to analyze and display acquired ultrasound information.
Claims
1. A distributed patient monitoring system comprising: at least one standalone portable ultrasound imaging unit configured to be fixed to a stable position against the skin on a patient's body and capable of prolonged ultrasound data acquisition, including an ultrasound imaging array, transmit-receive circuitry, a beamformer, backend signal and image processing subsystem, power and communication subsystems; and a monitoring workstation connected to each standalone portable ultrasound imaging unit configured to request and receive ultrasound imaging information from each standalone portable ultrasound imaging unit, and configured to analyze and display acquired ultrasound information.
2. The distributed patient monitoring system according to the claim 1 wherein a plurality of the said at least one standalone portable ultrasound imaging units are configured to monitor conditions of a patient from different scanning positions and orientations.
3. The distributed patient monitoring system according to the claim 1 wherein a plurality of the said at least one standalone portable ultrasound imaging units are configured to be connected to a multitude of patients to monitor the multitude of patients' conditions
4. The distributed patient monitoring system according to the claim 1 wherein the monitoring workstation is configured to request an ultrasound image from each standalone portable ultrasound imaging unit intermittently according to a pre-programmed frequency of acquisition, and wherein each ultrasound imaging array has multiple channels with each channel using less than 40 milliwatts.
5. The distributed patient monitoring system according to the claim 1 wherein an imaging frame orientation, a frequency of acquisition, and scanning parameters, are set dynamically by the monitoring workstation for each standalone portable ultrasound imaging unit, and wherein each ultrasound imaging array has multiple channels with each channel using less than 25 milliwatts.
6. The distributed patient monitoring system according to the claim 1 wherein an imaging frame orientation, a frequency of acquisition, and scanning parameters for each standalone portable ultrasound imaging unit are controlled from a remote location, and wherein each ultrasound imaging array has multiple channels with each channel using less than 40 milliwatts.
7. The distributed patient monitoring system according to the claim 1 wherein the monitoring workstation is configured to display at least one integrated parameter related to patient health condition inferred from ultrasound image and from ancillary sensor data, and wherein each ultrasound imaging array has multiple channels with each channel using less than 40 milliwatts.
8. The distributed patient monitoring system according to the claim 7 wherein the monitoring workstation is configured to alert an operator to changes in at least one parameter inferred from ultrasound image and ancillary sensor data.
9. The distributed patient monitoring system according to the claim 8 wherein the monitoring workstation is configured to alert operator to changes in at least one parameter and configured to suggest the operator an optimal course of action.
10. The distributed patient monitoring system according to the claim 1 wherein the monitoring workstation is configured to wirelessly transmit patient data to an ancillary portable display, and wherein each ultrasound imaging array has multiple channels with each channel using less than 40 milliwatts.
11. The distributed patient monitoring system according to the claim 1 wherein each ultrasound imaging array comprises a 2D array, and wherein each ultrasound imaging array has multiple channels with each channel using less than 40 milliwatts.
12. The distributed patient monitoring system according to the claim 11 wherein each 2D ultrasound imaging array, transmit-receive circuitry, and beamformer are formed as a single chip ultrasound system.
13. The distributed patient monitoring system according to the claim 12 wherein each standalone portable ultrasound imaging unit comprises the single chip ultrasound system.
14. The distributed patient monitoring system according to the claim 1 wherein each standalone portable ultrasound imaging unit includes a small visual display attached to unit and configured to display at least one of i) vital integrated data or health parameters the unit receives from the workstation, ii) progress of the scan, iii) guidance and directions to the operator for the attention of the operator or a patient.
15. The distributed patient monitoring system according to the claim 1 wherein ultrasound data recorded by each unit includes at least one of raw RF data, I/Q data, B-mode data, continuous wave Doppler, color Doppler, vector flow imaging data, shear-wave elastography, and acoustic radiation pressure imaging data.
16. A distributed patient monitoring system for cardiopulmonary resuscitation (CPR) comprising: A standalone portable ultrasound imaging unit configured to be fixed to a stable position against the neck of a patient's body and capable of prolonged ultrasound data acquisition, including an ultrasound imaging array, transmit-receive circuitry, a beamformer, backend signal and image processing subsystem, power and communication subsystems, wherein the standalone portable ultrasound imaging unit is configured to measure a carotid blood flow for detecting an underlying rhythm during cardiopulmonary resuscitation (CPR) in order to provide a rescuer with information including at least one of i) an efficacy of chest compressions, ii) a return of spontaneous circulation, and iii) an underlying cardiac rhythm without cessation of external cardiac compression by the rescuer; and A monitoring workstation connected to the standalone portable ultrasound imaging unit configured to request and receive ultrasound imaging information from the standalone portable ultrasound imaging unit, and configured to analyze and display acquired ultrasound information.
17. The distributed patient monitoring system for cardiopulmonary resuscitation according to the claim 16 wherein the standalone portable ultrasound imaging unit is integral with a display of acquired ultrasound information.
18. The distributed patient monitoring system for cardiopulmonary resuscitation according to the claim 16 wherein the display includes means for providing visual and/or auditory cues to change a rate, a rhythm, or a force of the chest compressions to the rescuer to optimize cerebral blood flow.
19. A patient monitoring system for cardiopulmonary resuscitation (CPR) comprising: A standalone portable unit configured to be fixed to a stable position against the skin on a patient's body and configured to measure a carotid blood flow for detecting an underlying rhythm during cardiopulmonary resuscitation (CPR); and A display connected to the standalone portable unit configured to provide a rescuer with information including at least one of i) an efficacy of chest compressions, ii) a return of spontaneous circulation, and iii) an underlying cardiac rhythm without cessation of external cardiac compression by the rescuer.
20. The patient monitoring system for cardiopulmonary resuscitation (CPR) according to the claim 19 wherein the standalone portable unit includes a strain sensor for measurement of carotid blood flow, and ECG sensor, and a CPR magnetic sensor.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
[0045] The present invention relates to ultrasound diagnostic systems, such as used in medical diagnostic systems for medical human and animal applications. Some aspects of the present invention, such as the construction and operation of an analog store digital read beamforming system and method are understood in connection with WO/2014/125371, corresponding to PCT/IB2014/000281 and WO/2016/077822 corresponding to PCT/US15/60861, which applications are incorporated herein by reference. The analog store digital read beamforming system and method used in the present system allows for each channel to use less than 40 milliwatts in operation and generally less than 25 milliwatts in operation. Outside of human and animal applications, the system and method of the present invention is also applicable to non-destructive testing/evaluation (e.g., pipeline testing, airframe testing, turbine blades testing, bridge and structural testing, and manufacturing testing), particularly where there is a need for task of long-term remote ultrasound monitoring. The system and method of the present invention is also applicable to sonar applications, and generally any ultrasound imaging (or image-like) applications requiring long term ultrasound based monitoring.
[0046] The present invention is directed in particular the way signals coming from the one, or a bank or series, of compact standalone ultrasound imaging units are treated. The invention describes an improved ultrasound monitoring system that provides better image quality combined with significant reduction in systems' size, power consumption and production cost as compared to current systems.
[0047] Thus, even though the main area of application of this invention is in medical ultrasound, this architecture and the hardware and software built upon its principles can be used in other areas such as non-destructive testing, sonar, radar, terahertz, infrared, optical imaging systems or for seismic geophysical exploration, just to name a few examples.
[0048] The general idea of the invention is to create a remote patient monitoring system that would use a portable standalone ultrasound imaging unit, and optionally physiological signals from an ancillary array of sensors, to remotely monitor the patient's health, diagnose the patient condition and alert an operator if some actions need to be taken.
[0049]
[0050] Specialized mounting components may be provided for stable positioning on different places of a subject's anatomy and are designed with one or more integral or detachable mounts for receiving a portable ultrasound unit 100, and positioning such a unit 100 on a skin surface of a patient. Elastic bands, skin adhesive or similar components may be provided to at least partially underlie the framework component of the unit 100, providing a comfortable interface with a subject's anatomical surface and providing an effective mounting surface for a framework component. In one embodiment, a band 102 may be provided as a flexible, elastic component sized and configured to contact (directly or indirectly) a desired location on a subject's anatomy and provide a contact surface for a framework component of the unit 100.
[0051] In some embodiments, bands 102 provided for contacting a subject are adjustable and may incorporate padding or comprise a material that's comfortable against a skin surface.
[0052] In some embodiments, bands 102 provided for contacting a subject and providing an interface for positioning the framework component of each unit 100 may comprise both flexible and substantially rigid portions.
[0053] In some embodiments, such bands 102 may be provided with stiff framework interface member(s) that mate with a corresponding interface member(s) provided on the framework component of each unit 100 for stably and positively positioning the framework component of the unit 100 on the band. In some embodiments, the imaging unit 100 may be temporarily or semi-permanently attached to the skin of the patient using skin adhesive.
[0054] The probe mount system also allows for an ultrasonically transparent standoff pad (spacer) be secured between the unit 100 and the patient's skin for imaging of hard to reach places, or for other reasons.
[0055] Each portable ultrasound imaging unit 100 is a small, generally a disc which is 25 mm in height and 75 mm in diameter or smaller, standalone battery powered, analog store digital read, ultrasound device that wirelessly transmits ultrasound data or images via wireless link 104, or wired link 106, to a remote patient monitoring system, workstation or a display.
[0056] The preferred embodiment has the ultrasound 2D array 124 with fully addressable elements 126, however in other embodiment this array 124 can be an annular, curved, linear or some combination thereof, of a phased 1.75D, 1.5D, or 1D array, composed of piezo, cMUT or pMUT elements. The array is connected to analog front-end and beamformer 122 that outputs analog beamformed RF signal to the back-end block 128 where this signal is digitized and processed to for an ultrasound image frame.
[0057] In other embodiments, the array 124 is divided into a number of sub-apertures and analog front-end 122 instead of a single RF signal is capable of producing a multitude of beamformed analog RF signal one for every sub-aperture.
[0058] In other embodiments, the portable ultrasound imaging unit may have a visual display attached to the top or being an integral part of the device itself, that may be used to display some vital integrated data, such as a progress of the scan, guidance and directions to the operator or other information for immediate attention of the operator or a patient.
[0059] In the preferred embodiment, ultrasound unit 100 is capable of continuously acquiring ultrasound data or can be program to acquire a frame or volume of data intermittently
[0060] In the preferred embodiment, the 2D array 124 of ultrasound unit 100 is fully addressable such that remote operator can select which plane or a volumetric slice to capture.
[0061] In the preferred embodiment, ultrasound unit 100 is capable of continuously or intermittently acquiring ultrasound data for B-mode imaging as well as for various other ultrasound modalities including, but not limited to, continuous wave Doppler, color Doppler, vector flow imaging methods, shear-wave elastography (SWE), acoustic radiation pressure imaging etc.
[0062] In one embodiment, a portable ultrasound unit can be a TEE probe with wireless link to the workstation 110.
[0063] In another embodiment one or some of ultrasound units 100 could be connected to other medical devices, such as a nasogastric tube, endotracheal tube, Foley catheter, etc.
[0064] In another embodiment one or some of ultrasound units 100 could be placed within a body cavity, such as rectal or gynecological probes for IGRT organ position tracking, surgery or monitoring.
[0065] The digitized data from the back-end processor 128 are sent to the remote workstation 110 via wireless data controller 130. In the preferred embodiment controller 130 is capable of operating in WiFi mode or UWB or Bluetooth mode depending on the data throughput, range and power available.
[0066] In another embodiment, wireless controller 130 is also capable of sending data via wired link using available common data transfer protocol such as USB3.
[0067] Each portable ultrasound unit 100 can work for extended periods of time ether on batteries 132 or using external power.
[0068] The portable ultrasound unit 100 also has brackets 134 for straps or mounts that keep the unit 100 secured on the patient's body.
[0069] In one embodiment, the portable ultrasound unit has additional array of sensors 140 that can provide supplemental physiological data, such as skin temperature, conductivity, pulse, blood oxygenation levels (such as via photo-plethysmography), etc. to the monitoring station 110. The types of supplemental physiologic sensors 140 is limitless and any known sensors with low power requirements can be utilized as desired. In another embodiment, some of additional sensors 140 could be interventional.
[0070] In one embodiment, a portable ultrasound unit 100 has a gel pouch or pack and a gel feeding device that can be used to replenish the contact gel between the transducer surface and the skin.
[0071] In the preferred embodiment, a single or a multitude of portable ultrasound units 100 are connected to the remote patient monitoring system 110 by a wireless data transmission link 112 as illustrated by
[0072] The remote patient monitoring system 110 can be a computer workstation, a specialized unit or as simple as a smartphone or a tablet.
[0073] In another embodiment the remote patient monitoring system 110 can be a specially constructed miniature controller that can use a common flat TV to display ultrasound images and physiological information.
[0074] In another embodiment the remote patient monitoring system 110 can include a workstation with telemedicine capabilities relating diagnostic information to the remote observer and allowing the remote operator to control scanning process on the portable ultrasound unit 100.
[0075] In another embodiment, the portable ultrasound units 100, instead of connecting directly to the remote station 110, can be connected to an interface unit 108 secured to the patient by straps 102 that takes the task of communicating to the remote patient monitoring system by a wireless data transmission link 112.
[0076] In another embodiment, the interface unit 108 can be connected to ultrasound units 100 via wired link 106.
[0077] In another embodiment, the interface unit 108 can communicate to multitude of ultrasound units 100, combine their signals for transmission to the remote station 110.
[0078] In another embodiment, ultrasound units 100 that are connected to interface unit 108 by wired link can be supplied with power from the interface unit 108.
[0079] In another embodiment, illustrated by the
[0080] In another embodiment, illustrated by the
[0081] One significant area for applications of portable ultrasound monitors is the cardiopulmonary resuscitation (CPR) procedures with the main goal of the portable ultrasound monitor being to provide the rescuer with information relating to the efficacy of chest compressions, return of spontaneous circulation, and underlying cardiac rhythm without cessation of external cardiac compression by the rescuer.
[0082] Currently during CPR, there is no method to detect return of spontaneous circulation without doing a physical “pulse check”. A pulse check consists of stopping external cardiac compression (CPR) in order to palpate the carotid artery for a pulse. However, palpation is limited in accuracy and is unreliable (CPR is given when not needed 36% of the time and not given when needed 14% of the time according to Tibballs J., et al. “Reliability of pulse palpation by healthcare personnel to diagnose pediatric cardiac arrest”. Resuscitation. 2009; 80). Further, current Advanced cardiac life support (ACLS) recommendations that any stoppage in CPR be limited as much as possible as delays in CPR decrease survival. The American Heart Association (AHA) and European Resuscitation Council developed the most recent ACLS guidelines. Certainly, not giving CPR when there is no cardiac output is detrimental to survival. However, giving CPR when the pulse has returned may also be detrimental as there may be initiation of an arrhythmia due to cardiac compression during certain portions of the heart's electrical cycle.
[0083] While ACLS CPR guidelines recommend a compression depth of 1.5 to 2 cm, with the goal of providing cerebral perfusion while there is inadequate cardiac contractility due to arrhythmia. Currently, there is no way to estimate if there is adequate cerebral blood flow except for palpation of the carotid artery during CPR. While a person palpating the carotid can provide feedback to the person performing CPR by asking for more depth of compression, this requires 2 people to perform the chest compressions, and this is not feasible in many settings where a cardiac arrest may occur (out of hospital settings, ambulance transport, wards or emergency departments in smaller hospitals).
[0084] ACLS recommendations also recommend “complete recoil” during compressions and specific compressions to respirations (compression to ventilation ratio). Both of these recommendations are related to allowing the heart of completely fill with blood prior to subsequent chest compressions. During a cardiac arrest event, carrying out these tasks can be difficult (tracking compression to ventilation and allowing for chest recoil). All of this can impact the cerebral blood flow. By having a blood flow monitor, the person performing CPR can be guided to the most effective rate, depth, and rhythm for effective CPR.
[0085] There is currently no method for detecting the underlying rhythm during CPR. During CPR, the chest where the electrocardiographic (ECG) monitors are located is subjected to movement. Consequently, the ECG signal reflects the motion of the chest and not the underlying cardiac electrical rhythm. Currently, CPR has to be stopped to evaluate the underlying rhythm. Since any stoppage in CPR results in a detriment in survival, current recommendations are that CPR should occur immediately after defibrillation and any stoppage in CPR should not occur more frequently than every 2 minutes. It is known that rapid defibrillation of ventricular fibrillation results in a higher success in return of spontaneous circulation. Thus being able to detect the underlying rhythm during CPR (without stopping CPR) could be an advantage for survival because there would be no need to stop CPR to check the rhythm and if ventricular fibrillation occurred during CPR, the provider would immediately know and could treat immediately.
[0086]
[0087] Such tasks however can be accomplished with an aid of much simpler device, that have reduced number of sensors, but having an integrated visual display to guide the operator (rescuer) in course of CPR or to give an instant rating or gauging of patient health state. This may represent another embodiment of the same basic invention.
[0088]
[0089] An integrated adherent strap that facilitate the contact of the arrays 124 to the skin of the patient can be fixed to underside of the device 140 to hold device in place as well as to provide the acoustic contact for the array and ancillary sensors.
[0090] The strap could be a self-adherent strap (e.g., peel off cover revealing adhesive layer) or it could be an elastic band as it was described elsewhere in the patent.
[0091] The sensor could be incorporated into the wiring of the defibrillator pads of an AED (automatic external defibrillator) or as part of a Life Pak monitor defibrillator.
[0092] The ancillary sensor array could include a strain sensor for carotid blood flow, ECG sensors, and a CPR sensor (magnet). There would be a processor to correlate the CPR sensor signals to the strain (carotid) sensor and the ECG sensors.
[0093] The strain (carotid) sensor will be compared to the CPR (magnet) sensors to determine the effectiveness of the chest compressions. The processor using the strain sensor input and the CPR sensor input would give visual and auditory cues via display 146 to change the rate, rhythm, and force of the chest compressions to optimize the cerebral blood flow.
[0094] The ECG sensors would be correlated to the strain (carotid) sensor for detection of return of normal circulation. (ECG and Pulse correlated after removing the CPR signals).
[0095] The ECG sensor would be correlated to the CPR signal and with the CPR motion removed from the signal, the underlying rhythm can be determined in a real time basis during CPR. This information can be used to optimize defibrillation timing.
[0096] During periods of arrhythmia needing pacing, the ECG sensors can be used in conjunction with the strain (carotid) sensor to optimize the current output and sensitivity settings of the electrical paced rhythm for external pacing.
[0097] In one embodiment, multiple units 100 can be strapped to a patient, or on many different patients, and one or all monitors can be communicating with the remote station. The remote station 110 can be monitoring many separate patients and ultrasound units 100 simultaneously.
[0098] In one embodiment, intelligent software can be utilizing intelligent algorithms to process the ultrasound images and detect problems, issues or specific occurrences with the patient. During the long term monitoring (i.e. cardiac) the image acquisition can be triggered by an external event (i.e. change in pulse or blood pressure). If such issues are detected, alerts can be sounded for hospital staff, and emails, texts, etc. sent to alert the staff.
[0099] The remote station 110 can be programmed to scan wakeup, scan and produce ultrasound images or volumes, collect physiological information from a chosen patients and selected units 100, send them back to the remote station 100 or send them via email, text, etc. to appropriate medical personnel.
[0100] The portable ultrasound units 100 can be turned on, off and imaging parameters changed from the anywhere in the connected network. They can be programmed to scan for X period of time while recording video, and then do that every hour etc.
[0101] In the preferred embodiment, the array of ultrasound unit 100 is capable of obtaining 2D image slice in any projection or 3D volume with orientation and scan parameters remotely controlled by an operator.
[0102] In the preferred embodiment, portable ultrasound units 100 are capable of acquiring Doppler imaging.
[0103] In one embodiment, portable ultrasound units 100 can be capable BW ultrasound only.
[0104] In another embodiment, some portable ultrasound units 100 can be capable BW ultrasound only while other units are Doppler enabled.
[0105] In the preferred embodiment, data from few ultrasound imaging units 100 can be combined (fused) to create a single image or data volume. For example if one unit 100 images the heart from apical prospective while second unit looks at the heart parasternal, the data volumes could be fused to create a single cardiac image.
[0106] In another preferred embodiment, ultrasound units 100 could be equipped with position and orientation sensors such as inertial navigation system, such that the position and orientation of each unit 100 can be obtained and ultrasound data from such units could be combined into a single image or volume. Essentially, the multitude of position tracked units 100 can be seen as a single composite ultrasound array.
[0107] In another embodiment, one of such position tracked enabled units 100 can be used as a stationary imaging unit while another position tracked unit 100 is used for free hand image acquisition with data from all units fused for imaging and analysis.
[0108] It should be noted that the patient monitoring system is implemented partially in hardware, partially in firmware and partially in software such that precise boundaries between these parts can be established by the needs of the implementation. Further, in all descriptions and schematic diagrams the placement of elements or blocks, etc. that are secondary to the understanding of the invention are not strictly followed, assuming that anybody with ordinary knowledge of electronic design would understand their functions would determine where they should be placed in the actual working schematics, their structure, and parameters.
[0109] The above description describes an ultrasound patient monitoring system and method for an ultrasound imaging system comprising the steps of: i) Providing an ultrasonic array formed of individual ultrasonic array elements configured for transmission and receiving; ii) Dividing the individual array elements into individual channels, wherein each channel comprises at least one array element; iii) Creating a receiving input signal for each channel from inputs received from each array element of the channel; iv) Sampling each receiving input signal for each channel at a sampling rate and storing the sampled data in a data bank which is associated with that channel; v) Selecting at least one data from at least one channel for each particular output time for each beamforming instance in accordance with a beamforming algorithm; vi) Summing all of the selected data from the associated channels for the beamforming instance forming an analog beamformed received signal sample for the beamforming instance; vii) Digitizing the analog beamformed received signal sample; viii) Producing an image frame or a volume slice from the data; ix) Sending data to the remote workstation; x) Sending physiological sensor information to the remote workstation; xi)
[0110] Another advantage of the invention is that such compact system allows sending data and diagnostic images wirelessly to any image display equipped to receive such transmissions or having such a receiver attached to data ports such as USB or FireWire of the display unit.
[0111] Another advantage of the invention is that it has scalable architecture enabling the construction of distributed ultrasound arrays with any number of elements by linear expansion.
[0112] Another advantage of the invention is that it improves image quality and reduces the cost of systems built with 1.5D, 1.75D and 2D arrays.
[0113] Although the present invention has been described with particularity herein, the scope of the present invention is not limited to the specific embodiments disclosed. It will be apparent to those of ordinary skill in the art that various modifications may be made to the present invention without departing from the spirit and scope thereof.