Not Applicable
Appendix A referenced herein is a computer program listing in a text file entitled “UC—2011—037—2_US_source_code_listing.txt” created on Jun. 25, 2013 and having a 27 kb file size. The computer program code, which exceeds 300 lines, is submitted as a computer program listing appendix through EFS-Web and is incorporated herein by reference in its entirety.
A portion of the material in this patent document is subject to copyright protection under the copyright laws of the United States and of other countries. The owner of the copyright rights has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the United States Patent and Trademark Office publicly available file or records, but otherwise reserves all copyright rights whatsoever. The copyright owner does not hereby waive any of its rights to have this patent document maintained in secrecy, including without limitation its rights pursuant to 37 C.F.R. §1.14.
1. Field of the Invention
This invention pertains generally to tissue oximetry, and more particularly to tissue oximetry and perfusion imaging.
2. Description of Related Art
Patients' skin integrity has long been an issue of concern for nurses and in nursing homes. Maintenance of skin integrity has been identified by the American Nurses Association as an important indicator of quality nursing care. Meanwhile, ulcers, and specifically venous and pressure ulcers, remain major health problems, particularly for hospitalized older adults. Detecting early wound formation is an extremely challenging and expensive problem.
When age is considered along with other risk factors, the incidences of these ulcers are significantly increased. Overall incidence of pressure ulcers for hospitalized patients ranges from 2.7% to 29.5%, and rates of greater than 50% have been reported for patients in intensive care settings. In a multicenter cohort retrospective study of 1,803 older adults discharged from acute care hospitals with selected diagnoses, 13.2% (i.e., 164 patients) demonstrated an incidence of stage I ulcers. Of those 164 patients, 38 (16%) had ulcers that progressed to a more advanced stage.
Pressure ulcers additionally have been associated with an increased risk of death within one year after hospital discharge. The estimated cost of treating pressure ulcers ranges from $5,000 to $40,000 for each ulcer, depending on severity. Meanwhile, venous ulcers can also cause significant health problems for hospitalized patients, especially in older adults. As many as 3% of the population suffer from leg ulcers, while this figure rises to 20% in those over 80 years of age. The average cost of treating a venous ulcer is estimated at $10,000, and can easily rise as high as $20,000 without effective treatment and early diagnosis.
Once a patient has been afflicted by a venous ulcer, the likelihood of the wound recurring is also extremely high, and ranges from 54% to 78%. This means that venous ulcers can have severely negative effects on those who suffer from them, significantly reducing quality of life and requiring extensive treatment. The impact of venous ulcers is often underestimated, despite accounting for as much as 2.5% of the total health care budget.
The high cost and incidence rates of venous ulcers, coupled with the difficulty in treating them, mark an extremely good opportunity to introduce a low cost, non-invasive system capable of early detection. While traditional laser Doppler systems are able to deliver relatively accurate and reliable information, they cannot be used for continuous monitoring of patients, since they require bulky and extremely expensive equipment. Such solutions that are too expensive or difficult to deploy significantly limit adoption.
Hence, there is a need to develop a monitoring and preventive solution to scan the tissue and measure tissue perfusion status as a measure for the level of oxygen distribution and penetration throughout the tissue as an indicator of tissue health. Accordingly, an object of the present invention is the use of photoplethysmographic in conjunction with pressure sensor signals to monitor perfusion levels of patients suffering from or at risk of venous ulcers.
The systems and methods of the present invention include a compact perfusion scanner configured to scan and map tissue blood perfusion as a mean to detect and monitor the development of ulcers. The device incorporates a platform, a digital signal processing unit, a serial connection to a computer, pressure sensor, pressure metering system, an LED and photodiode sensor pair and a data explorer visual interface.
The systems and methods of the present invention provide effective preventive measures by enabling early detection of ulcer formation or inflammatory pressure that would otherwise have not been detected for an extended period, thus increasing risk of infection and higher stage ulcer development.
In a preferred embodiment, the compact perfusion scanner and method of characterizing tissue health status according to the present invention incorporates pressure sensing components in conjunction with the optical sensors to monitor the level of applied pressure on target tissue for precise skin/tissue blood perfusion measurements and oximetry. The systems and methods of the present invention enable new capabilities including but not limited to: measurement capabilities such as perfusion imaging and perfusion mapping (geometric and temporal), signal processing and pattern recognition, automatic assurance of usage via usage tracking and pressure imaging, as well as data fusion.
One particular benefit of the sensor-enhanced system of the present invention is the ability to better manage each individual patient, resulting in a timelier and more efficient practice in hospitals and even nursing homes. This is applicable to patients with a history of chronic wounds, diabetic foot ulcers, pressure ulcers or post-operative wounds.
In addition, alterations in signal content may be integrated with the activity level of the patient, the position of patient's body and standardized assessments of symptoms. By maintaining the data collected in these patients in a signal database, pattern classification, search, and pattern matching algorithms may be used to better map symptoms with alterations in skin characteristics and ulcer development.
An aspect is an apparatus for monitoring perfusion oxygenation of a target tissue region of a patient, comprising: a scanner comprising: a planar sensor array; the sensor array configured to be positioned in contact with a surface of the target tissue region; the sensor array comprising one or more LED's configured to emit light into the target tissue region at a wavelength keyed for hemoglobin; the sensor array comprising one or more photodiodes configured to detect light reflected from the LED's; and a data acquisition controller coupled to the one or more LED's and to the one or more photodiodes for controlling the emission and reception of light from the sensor array to obtain perfusion oxygenation data associated with the target tissue region.
Another aspect is a system for monitoring perfusion oxygenation of a target tissue region of a patient, comprising: (a) a scanner comprising: a planar sensor array; the sensor array configured to be positioned in contact with a surface of the target tissue region; the sensor array comprising one or more light sources configured to emit light into the target tissue region at a wavelength keyed for hemoglobin; the sensor array comprising one or more sensors configured to detect light reflected from the light sources; a pressure sensor coupled to the sensor array; the pressure sensor configured to obtain pressure readings of the sensor array's contact with a surface of the target tissue region; and (b) a data acquisition controller coupled to the one or more sensors and for controlling the emission and reception of light from the sensor array to obtain perfusion oxygenation data associated with the target tissue; and (c) a processing module coupled to the data acquisition controller; (d) the processing module configured to control sampling of the pressure sensor and sensor array for simultaneous acquisition of perfusion oxygenation data and pressure sensor data to ensure proper contact of the scanner with the surface of the target tissue region.
A further aspect is a method for performing real-time monitoring of perfusion oxygenation of a target tissue region of a patient, comprising: positioning a sensor array in contact with a surface of the target tissue region; emitting light from lights sources in the sensor array into the target tissue region at a wavelength keyed for hemoglobin; receiving light reflected from the light sources; obtaining pressure data associated with the sensor array's contact with a surface of the target tissue region; obtaining perfusion oxygenation data associated with the target tissue region; and sampling the perfusion oxygenation data and pressure data to ensure proper contact of the sensor array with the surface of the target tissue region.
It is appreciated that the systems and methods of the present invention are not limited to the specific condition of ulcer or wound, but may have broad application in all forms of wound management, such as skin diseases or treatments.
Further aspects of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention without placing limitations thereon.
The invention will be more fully understood by reference to the following drawings which are for illustrative purposes only:
The system 10 comprises sensing hardware component 16 that includes arrays of emitters/sensors (44, 46, 50) and data acquisition unit 40, preferably in a handheld enclosure (not shown). The LED array 44 and photodiode arrays 46 coupled to the data acquisition unit 40 (e.g. through cabling or wireless connection) can be physically configured in a variety of arrays. The data acquisition unit 40 is preferably capable of interfacing with a large number of individual LEDs and photodiodes. Signal amplification and filtering unit 49 may be used to condition the photodiode signal/data prior to being received by the data acquisition unit 40. In a preferred embodiment, the photodiode signal amplification and filtering unit 49 may comprise a photodiode read circuit 120 shown in
Sensing/scanning hardware component 16 may also include an intensity controller 42 for controlling the output of LED array 44. Intensity controller 42 preferably comprises LED driver circuit 100 shown in
The data acquisition system 40 also interfaces with application module 14 on PC 154 (see
The pressure sensor 50 is configured to measure the pressure applied from the hardware package 16 on to the patient's tissue, such that pressure readings may be acquired to maintain consistent and appropriate pressure to the skin 52 while measurements are being taken. The pressure sensor 50 may be coupled to pre-conditioning or metering circuitry 48 that includes amplification and filtering circuitry to process the signal prior to being received by the data acquisition controller 40.
The LED arrays 44 are configured to project light at wavelengths keyed for hemoglobin in the target tissue 52, and the photodiode sensor arrays 46 measure the amount of light that passes through tissue 52.
The signal processing module 12 then further processes and filters the acquired data via processing scripts 24 and filtering module 22. The signal processing module 12 further comprises a feature extraction module 28, which may be output to visual interface 36 for further processing and visualization. A perfusion data module 26 converts data into a Plethysmograph waveform, which may be displayed on a monitor or the like (not shown). The interface 36 and processing module 12 may also be configured to output an overlay image of the tissue and captured perfusion data 26.
In order to produce the wavelengths of light corresponding to deoxy and oxyhemoglobin absorption, the system 12 preferably uses light emitting diodes for the emitting source array 44. In a preferred embodiment, the system 10 incorporates the DLED-660/880-CSL-2 dual optical emitter combinations from OSI Optoelectronics. This dual emitter combines a red (660 nm) and infrared (880 nm) LED into a single package. Each red/infrared LED pair requires a 20 mA current source and have a 2.4/2.0V forward voltage respectively. It is appreciated that other light sources may also be used.
In order to measure a photoplethysmograph, the light reflected from the LED array 44 is detected by the photodiode array 46. In a preferred embodiment, the PIN-8.0-CSL photodiode from OSI Optoelectronics is used. This photodiode has a spectral range of 350 nm to 1100 nm and has a responsivity of 0.33 and 0.55 to 660 nm and 900 nm light respectively.
As shown in
Referring to
The arrays 44, 46 are shown in
Driver circuit 100 includes a low-noise amplifier 110 coupled to the LED 64. In a preferred embodiment, the amplifier 110 comprises a LT6200 chip from Linear Technologies. However, it is appreciated that other amplifiers available in the art may also be employed. LED driver circuit 100 further comprises a p-channel MOS field-effect transistor (FET) 112 (e.g. MTM76110 by Panasonic), which provides negative feedback. As voltage is increased at the input, so is the voltage across the 50 ohm resistor 102. This results in larger current draw, which goes through the LED 64, making it brighter. At 2V, approximately 40 mA is drawn through the LED 64, providing optimal brightness. If the voltage at the input is increased too far, the voltage drop across the LED 64 will be insufficient to turn it off, but there will still be a large amount of current flowing through the LED 64 and resistor 102, resulting in large heat buildup. For this reason, the input voltage is ideally kept below 3V to minimize overheating and prevent component damage. If the input to the op-amp 110 is floated while the amp 110 is powered, a 100 k pull-down resistor 104 at the input and 1 k load resistor 108 at the output ensure that the circuit 100 remains off. The 1 k load resistor 108 also ensures that the amp 110 is able to provide rail to rail output voltage. The 1 uF capacitor 114 ensures that the output remains stable, but provides enough bandwidth for fast LED 64 switching. To provide further stabilization, the driver circuit 100 may be modified to include Miller compensation on the capacitor 114. This change improves the phase margin for the driver circuit 100 at low frequencies, allowing more reliable operation.
The photodiode read circuit 120 operates via a simple current to voltage op-amp 124 as shown in
The feedback is controlled by a simple low pass filter 126 with a 2.7 pF capacitor 129 and a 100 kilo-ohm resistor 130. The 0.1 uF capacitor 128 is used to decouple the voltage divider from ground. The circuit amplifies the current output of the photodiode and converts it to voltage, allowing the data acquisition unit to read the voltage via its voltage input module.
It is appreciated that the individual components of the LED driver circuit 100 and photodiode read circuit 120 are shown for exemplary purposes only, and that other models, or types of components may be used as desired.
In one embodiment of the present invention, the data acquisition controller 40 comprises National Instruments CompactRIO 9014 real-time controller coupled with an NI 9104 3M gate FPGA chassis. The data acquisition controller 40 interfaces with the LED arrays 44 and photodiodes 46 using three sets of modules for current output, current input, and voltage input.
In one embodiment, the controller 40 comprises a processor, real-time operating system, memory, and supports additional storage via USB (all not shown). The controller 40 may also include an Ethernet port (not shown) for connection to the user interface PC 154. The controller 40 comprises an FPGA backplane, current output module (e.g. NI 9263), current input module (e.g. NI 9203), and voltage input module (e.g. NI 9205) allowing multiple voltage inputs from photodiode/amplifier modules.
The POM system 10 preferably employs a pressure sensor 50 to measure pressure and ensure consistent results (e.g. 1 lb. Flexiforce sensor). Due to the confounding effect varying pressure can have on plethysmograph measurements, readings from the pressure sensor 50 provide a metric from which the user can apply the sensor hardware 16 to the patient's skin 52.
The pressure sensor 50 is preferably attached behind the LED array 44, and measures the pressure used in applying it to a target location. The pressure sensor 50 is preferably configured to deliver accurate measurements of pressure in a specified range, e.g. a range from zero to approximately one pound, which encompasses the range of pressures that can reasonably be applied when using the POM sensing hardware 16.
The pressure sensor 50 is used to guide the user into operating the scanner 16 more consistently, so that the sensor/scanner 16 is positioned in a similar manner every measurement. The oximetry data that is taken is thus verified to be accurately taken by readings from the pressure sensor 50.
In a preferred embodiment, the pressure sensor 50 is calibrated in order to ensure that the pressure sensor gives repeatable, well understood measurements that can be directly translated into raw pressure values.
The results in
While the system 10 optimally uses data from the pressure sensor 50 to verify proper disposition of the scanner on the target tissue site 52, it is appreciated that in an alternative embodiment the user may simply forego pressure monitoring and monitor pressure manually (e.g. tactile feel or simply placing the scanner 16 on the tissue site 52 under gravity).
Referring to
With respect to the PC 154 interface shown in
In order to provide a more informative map of perfusion in a local region, interpolation of blood oximeter data may be conducted using sensor tracking data. The optical oximeter sensor 16 provides absolute SPO2 readings, giving the percent of blood that is oxygenated. This information, when associated with the location it was taken from, can be used to generate a map of blood oxygenation. In a preferred embodiment, the LED array 44 used for generating SPO2 readings is also used for determining location. However, it is appreciated that another optical sensor, e.g. laser (not shown), may be used to obtain location readings independently of the LED SPO2 readings. In such configuration, a low-power laser (similar to a laser-tracking mouse) is used to image a small area at very fast intervals, and then detects movement by how that image has shifted. This information is then converted to two dimensional ‘X’ and ‘Y’ position and displacement measurements.
In a preferred embodiment, interpolation is performed via a Kriging algorithm, and data points are mapped using the oximeter sensor 16 to track movement of the sensor 16 over the test area. Kriging is a linear least squares interpolation method often used for spatially dependent information. The interpolation is used to fill in the blank spots that a scan may have missed with estimated values. The interpolated data is compiled into a color coded image, and displayed to the user. This allows an accurate, anisotropic interpolation of the raw data, which makes the end result much easier to visualize. An example interpolation is shown in
To aid in visualizing the collected blood oximetry data, the processing software 12 preferably includes a feature extraction module 28 that that can detect markers on a picture, and then properly align and overlay blood oximetry data 26 (see
In one embodiment a mobile application (not shown) may be used to facilitate easy capture and integration of pictures for the processing software 12. The application allows a user to quickly take a picture with a mobile device (e.g. smartphone, or the like) and have it automatically sent over Bluetooth for capture by the processing software 12. The picture may then be integrated with the mapping system.
Acquired data from the data acquisition unit 40 (which may be stored on server 32) is first extracted at step 222 (via processing scripts 24). This extracted data is then used for simultaneously extracting location data, perfusion data and pressure data from each measurement point. The processing software 12 may simultaneously sample location, perfusion, and pressure readings (e.g. at 3 Hz interval), in order to creating a matching set of pressure, position, and blood oxygen measurements at each interval.
In order to generate useful information and metrics from the raw data recorded by the perfusion module 228, a number of algorithms are used.
At step 230, features are extracted from the data (e.g. via the feature extraction module 28). Position data corresponding to the hardware sensor 16 location is then mapped at step 232. After a scan has been completed, the oximetry data is mapped at step 234 to appropriate coordinates corresponding to the obtained sensor position data from step 232. At step 236, the mapped data is interpolated (e.g. using the Kriging algorithm shown in
On the perfusion side, RF noise filtering is then performed on the extracted data at step 224. Motion noise is then removed at step 226 to obtain the perfusion data at step 228. Steps 224 and 226 may be performed via filtering module 22.
In a preferred method illustrated in
As illustrated in
For the single sided method, only the preceding noise information from area 1 is used, and the relevant noise level is assumed to be the same in area 1 and 3. For the double sided method, noise from areas 1 and 2 is averaged. Finally, interpolation of the noise at 3 is attempted via interpolation, using the data from all available noise periods, preceding and following the target data point (3). The measurement data is averaged in these areas to generate a single point for each LED 64 pulse. The result is then low-pass filtered at the end to remove high frequency noise.
For the frequency response plots shown in
Frequency domain analysis/experiments were performed with the frequency domain signals of the plethysmograph measurements. The experiments revealed not only high magnitude elements at the heart rate frequency, but also its harmonics. This appears fairly consistent between locations.
In order to verify that the harmonics shown in the frequency domain were not the result of noise or jitter, but represented real components of the pulse waveform, a sinusoid wave was constructed. The sinusoid was created by summing sinusoids at the frequency for each separate pulse waveform peak. This superposition was intended to model the effects of frequency jitter in the waveform, while removing any frequency components due to the pulse waveform shape.
A comparison of signals is shown in
Experiments were performed on number of body locations, including neck, thumb and forehead using the perfusion system 10 of the present invention. Samples of extracted plethysmograph signals are reported in
The perfusion system 10 was also tested on a black tape, as a means to mark locations on tissue. Black tape was used to test as a marker on the skin. The sensor was used to measure signals on the tape, and just to the side of it. An impression on the skin can be seen where the reflectance sensor was used off the tape.
Embodiments of the present invention may be described with reference to flowchart illustrations of methods and systems according to embodiments of the invention, and/or algorithms, formulae, or other computational depictions, which may also be implemented as computer program products. In this regard, each block or step of a flowchart, and combinations of blocks (and/or steps) in a flowchart, algorithm, formula, or computational depiction can be implemented by various means, such as hardware, firmware, and/or software including one or more computer program instructions embodied in computer-readable program code logic. As will be appreciated, any such computer program instructions may be loaded onto a computer, including without limitation a general purpose computer or special purpose computer, or other programmable processing apparatus to produce a machine, such that the computer program instructions which execute on the computer or other programmable processing apparatus create means for implementing the functions specified in the block(s) of the flowchart(s).
Accordingly, blocks of the flowcharts, algorithms, formulae, or computational depictions support combinations of means for performing the specified functions, combinations of steps for performing the specified functions, and computer program instructions, such as embodied in computer-readable program code logic means, for performing the specified functions. It will also be understood that each block of the flowchart illustrations, algorithms, formulae, or computational depictions and combinations thereof described herein, can be implemented by special purpose hardware-based computer systems which perform the specified functions or steps, or combinations of special purpose hardware and computer-readable program code logic means.
Furthermore, these computer program instructions, such as embodied in computer-readable program code logic, may also be stored in a computer-readable memory that can direct a computer or other programmable processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function specified in the block(s) of the flowchart(s). The computer program instructions may also be loaded onto a computer or other programmable processing apparatus to cause a series of operational steps to be performed on the computer or other programmable processing apparatus to produce a computer-implemented process such that the instructions which execute on the computer or other programmable processing apparatus provide steps for implementing the functions specified in the block(s) of the flowchart(s), algorithm(s), formula(e), or computational depiction(s).
From the discussion above it will be appreciated that the invention can be embodied in various ways, including the following:
Although the description above contains many details, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. Therefore, it will be appreciated that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” All structural, chemical, and functional equivalents to the elements of the above-described preferred embodiment that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase “means for.”
Appendix A contains source code that is submitted by way of example, and not of limitation, as an embodiment of signal processing in the present invention. Those skilled in the art will readily appreciate that signal processing can be performed in various other ways, which would be readily understood from the description herein, and that the signal processing methods are not limited to those illustrated in Appendix A.
This application is a 35 U.S.C. §111(a) continuation of PCT international application number PCT/US2012/021919 filed on Jan. 19, 2012, incorporated herein by reference in its entirety, which is a nonprovisional of U.S. provisional patent application Ser. No. 61/434,014 filed on Jan. 19, 2011, incorporated herein by reference in its entirety. Priority is claimed to each of the foregoing applications. The above-referenced PCT international application was published as PCT International Publication No. WO 2012/100090 on Jul. 26, 2012 and republished on Sep. 13, 2012, and is incorporated herein by reference in its entirety.
Number | Date | Country | |
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61434014 | Jan 2011 | US |
Number | Date | Country | |
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Parent | PCT/US2012/021919 | Jan 2012 | US |
Child | 13942649 | US |