Contactless system and method for assessing tissue viability and other hemodynamic parameters
RE049639 · 2023-09-05
Assignee
Inventors
- Michele Pierro (Westford, MA, US)
- Kyle Quinn (Fayetteville, AR, US)
- Alan Woessner (Fayetteville, AR, US)
Cpc classification
A61B5/445
HUMAN NECESSITIES
A61B5/02028
HUMAN NECESSITIES
A61B2560/0223
HUMAN NECESSITIES
A61B5/0205
HUMAN NECESSITIES
A61B5/1455
HUMAN NECESSITIES
A61B5/349
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
A61B5/02
HUMAN NECESSITIES
A61B5/0205
HUMAN NECESSITIES
A61B5/1455
HUMAN NECESSITIES
Abstract
A contactless system for assessing tissue viability and other hemodynamic parameters includes one or more light sources configured to emit lights at a predetermined wavelength sensitive to hemoglobin concentration associated with spontaneous hemodynamic oscillations at tissue in a predetermined area of a human subject. One or more polarizers are each coupled to one or more of the one or more light sources and are configured to polarize the light to a polarized state such that the polarized light in the polarized state diffuses into the tissue in the predetermined area at a predetermined depth and the polarized light is maintained in the polarized state at the predetermined depth. One or more detectors each including a detector polarizer coupled thereto are configured to discriminate the light maintained in the polarized state and at the predetermined depth and are configured to generate a plurality of frames of the tissue in the predetermined area at the predetermined depth. A controller is coupled to the one or more light sources and the one or more detectors. The controller is configured to: acquire the plurality of frames, select a region of interest having the same coordinates for each of the plurality of frames, average the number of pixels within each region of interest to create a raw reference signal, detrend the raw reference signal to create a detrended raw reference signal, perform frequency domain analysis of the detrended raw reference signal, identify a frequency band of interest associated with the spontaneous hemodynamic oscillations, and perform an inverse fast Fourier transform within the frequency band of interest to generate a reference signal indicative of blood volume oscillations at a selected spontaneous hemodynamic oscillation. For each sample of the reference signal at a predetermined point in time, the controller multiplies the sample by each pixel of a frame at the same predetermined point in time to generate a three-dimensional coordinate matrix including a plurality of correlation matrix frames at each predetermined point in time. The controller adds the plurality of correlation matrix frames at each predetermined point in time to generate a two-dimensional hemodynamic map indicative of the strength of the spontaneous hemodynamic oscillation to assess the viability of the tissue in the predetermined area.
Claims
1. A contactless system for assessing tissue viability and other hemodynamic parameters, the system comprising: one or more light sources configured to emit lights at a predetermined wavelength sensitive to hemoglobin concentration associated with spontaneous hemodynamic oscillations at tissue in a predetermined area of a human subject; one or more polarizers each coupled to one or more of the one or more light sources configured to polarize the light to a polarized state such that the polarized light in the polarized state diffuses into the tissue in the predetermined area at a predetermined depth and the polarized light is maintained in the polarized state at the predetermined depth; one or more detectors each including a detector polarizer coupled thereto configured to discriminate the light maintained in the polarized state and at the predetermined depth and configured to generate a plurality of frames of the tissue in the predetermined area at the predetermined depth; and a controller coupled to the one or more light sources and the one or more detectors, the controller configured to: acquire the plurality of frames, select a region of interest having the same coordinates for each of the plurality of frames, average the number of pixels within each region of interest to create a raw reference signal, detrend the raw reference signal to create a detrended raw reference signal, perform frequency domain analysis of the detrended raw reference signal, identify a frequency band of interest associated with the spontaneous hemodynamic oscillations, perform an inverse fast Fourier transform within the frequency band of interest to generate a reference signal .Iadd.including a plurality of samples and .Iaddend.indicative of blood volume oscillations at a selected spontaneous hemodynamic oscillation, for each sample of the reference signal at a predetermined point in time, multiply the sample by each pixel of a frame at the same predetermined point in time to generate a three-dimensional coordinate matrix including a plurality of correlation matrix frames at each predetermined point in time, and add the plurality of correlation matrix frames at each predetermined point in time to generate a two-dimensional hemodynamic map indicative of the strength of the spontaneous hemodynamic oscillation to assess the viability of the tissue .Iadd.and/or the other hemodynamic parameters .Iaddend.in the predetermined area.
2. The system of claim 1 in which the spontaneous hemodynamic oscillations have a frequency in the range of 0.05 Hz to about 1.5 Hz.
3. The system of claim 1 in which the predetermined wavelength is in the range of about 500 nm to about 1,000 nm.
4. The system of claim 1 in which the predetermined depth is in the range of about 0.1 mm to about 0.5 mm.
5. The system of claim 1 in which the other hemodynamic parameters include one or more of: heart rate, resting heart rate, heart rate variability, and tissue saturation for patients suffering from diminished blood circulation.
6. The system of claim 1 in which the one or more detectors include a CCD camera.
7. The system of claim 1 in which the one or more detectors include a CMOS camera.
8. The system of claim 1 in which the predetermined area includes a burn area of the human subject.
9. The system of claim 1 in which the predetermined area includes a wound area of a human subject.
10. The system of claim 1 further including a light filtering lens coupled to one or more light sources.
11. A contactless method for assessing tissue viability and other hemodynamic parameters, the method comprising: emitting light at a predetermined wavelength sensitive to hemoglobin concentration associated with spontaneous hemodynamic oscillations at tissue in a predetermined area of a human subject; polarizing the light to a polarized state such that the polarized light in the polarized state diffuses into the tissue in the predetermined area at a predetermined depth and the polarized light is maintained in the polarized state at the polarized depth; discriminating the light maintained in the polarized state and at the predetermined depth and generating a plurality of frames of the tissue in the predetermined area at the predetermined depth; acquiring the plurality of frames; selecting a region of interest having the same coordinates for each of the plurality of frames; averaging the number of pixels within each region of interest to create a raw reference signal; detrending the raw reference signal to create a detrended raw reference signal; performing frequency domain analysis of the detrended raw reference signal; identifying a frequency band of interest associated with the spontaneous hemodynamic oscillations; performing an inverse fast Fourier transform within the frequency band of interest to generate a reference signal .Iadd.including a plurality of samples and .Iaddend.indicative of blood volume oscillations at a selected spontaneous hemodynamic oscillation; for each sample of the reference signal at a predetermined point in time, multiplying the sample by each pixel of a frame at the same predetermined point in time to generate a three-dimensional coordinate matrix including a plurality of correlation matrix frames at each predetermined point in time; and adding the plurality of correlation matrix frames at each predetermined point in time to generate a two-dimensional hemodynamic map indicative of the strength of the spontaneous hemodynamic oscillation to assess the viability of the tissue .Iadd.and/or the other hemodynamic parameters .Iaddend.in the predetermined area.
12. The method of claim 11 in which adding the plurality of correlation matrix frames at each predetermined point in time to generate a two-dimensional hemodynamic map indicative of the strength of the spontaneous hemodynamic oscillation assess the viability of other hemodynamic parameters including one or more of: heart rate, resting heart rate, heart rate variability, and tissue saturation for patients suffering from diminished blood circulation.
13. The method of claim 11 in which the spontaneous hemodynamic oscillations have a frequency in the range of 0.05 Hz to about 1.5 Hz.
14. The method of claim 11 in which the predetermined wavelength is in the range of about 500 nm to about 1,000 nm.
15. The method of claim 11 in which the predetermined depth is in the range of about 0.1 mm to about 0.5 mm.
16. The method of claim 11 in which the predetermined area includes a burn area of the human subject.
17. The method of claim 11 in which the predetermined area includes a wound area of a human subject.
.Iadd.18. A contactless system for assessing tissue viability and other hemodynamic parameters, the system comprising: one or more light sources configured to emit lights at a predetermined wavelength sensitive to hemoglobin concentration associated with spontaneous hemodynamic oscillations into tissue at a predetermined area of a human subject; one or more polarizers each coupled to one or more of the one or more light sources configured to polarize the light to a polarized state such that the polarized light in the polarized state diffuses into the tissue in the predetermined area at a predetermined depth range and the polarized light is maintained in the polarized state at the predetermined depth range; one or more detectors each including a detector polarizer coupled thereto configured to discriminate the light maintained in the polarized state and at the predetermined depth range from polarized light reflected from the tissue in the predetermined area which has not been maintained in the polarized state and configured to generate a plurality of frames of the tissue in the predetermined area at the predetermined depth; and a controller coupled to the one or more light sources and the one or more detectors configured to acquire the plurality of frames and configured to assess the viability of the tissue and/or the other hemodynamic parameters in the predetermined area using the discriminated light maintained in the polarized state and at the predetermined depth range..Iaddend.
.Iadd.19. The system of claim 18 in which the controller is configured to generate a two-dimensional hemodynamic map indicative of the strength of the spontaneous hemodynamic oscillation to further assess the viability of the tissue and/or the other hemodynamic parameters..Iaddend.
.Iadd.20. The system of claim 18 in which the controller is configured to perform one or more or all of the following: select a region of interest having the same coordinates for each of the plurality of frames; average the number of pixels within each region of interest to create a raw reference signal; detrend the raw reference signal to create a detrended raw reference signal; perform frequency domain analysis of the detrended raw reference signal; identify a frequency band of interest associated with the spontaneous hemodynamic oscillation; perform an inverse fast Fourier transform within the frequency band of interest to generate a reference signal including a plurality of samples and indicative of blood volume oscillations at a selected spontaneous hemodynamic oscillation; for each sample of the reference signal at a predetermined point in time, multiply the sample by each pixel of a frame at the same predetermined point in time to generate a three-dimensional coordinate matrix including a plurality of correlation matrix frames at each predetermined point in time; and add the plurality of correlation matrix frames at each predetermined point in time to generate a two-dimensional hemodynamic map indicative of the strength of the spontaneous hemodynamic oscillation to assess the viability of the tissue and/or the other hemodynamic parameters in the predetermined area..Iaddend.
.Iadd.21. The system of claim 18 in which the spontaneous hemodynamic oscillations have a frequency in the range of 0.05 Hz to about 1.5 Hz..Iaddend.
.Iadd.22. The system of claim 18 in which the predetermined wavelength is in the range of about 500 nm to about 1,000 nm..Iaddend.
.Iadd.23. The system of claim 18 in which the predetermined depth is in the range of about 0.1 mm to about 0.5 mm..Iaddend.
.Iadd.24. The system of claim 18 in which the other hemodynamic parameters include one or more of: heart rate, resting heart rate, heart rate variability, and tissue saturation for patients suffering from diminished blood circulation..Iaddend.
.Iadd.25. The system of claim 18 in which the one or more detectors include a CCD camera..Iaddend.
.Iadd.26. The system of claim 18 in which the one or more detectors include a CMOS camera..Iaddend.
.Iadd.27. The system of claim 18 in which the predetermined area includes a burn area of the human subject..Iaddend.
.Iadd.28. The system of claim 18 in which the predetermined area includes a wound area of a human subject..Iaddend.
.Iadd.29. The system of claim 18 further including a light filtering lens coupled to one or more light sources..Iaddend.
.Iadd.30. A contactless method for assessing tissue viability and other hemodynamic parameters, the method comprising: emitting light at a predetermined wavelength sensitive to hemoglobin concentration associated with spontaneous hemodynamic oscillations into tissue at a predetermined area of a human subject; polarizing the light to a polarized state such that the polarized light in the polarized state diffuses into the tissue in the predetermined area at a predetermined depth range and the polarized light is maintained in the polarized state at the polarized depth range; discriminating the light maintained in the polarized state and at the predetermined depth range from polarized light reflected from the tissue in the predetermined area which has not been maintained in the polarized state and generating a plurality of frames of the tissue in the predetermined area at the predetermined depth range; and acquiring the plurality of frames to assess the viability of the tissue and/or the other hemodynamic parameters in the predetermined area using the discriminated light maintained in the polarized state and at the predetermined depth range..Iaddend.
.Iadd.31. The method of claim 30 further including generating a two-dimensional hemodynamic map indicative of the strength of the spontaneous hemodynamic oscillation to further assess the viability of the tissue and/or the other hemodynamic parameters in the predetermined area..Iaddend.
.Iadd.32. The method of claim 30 further including performing one or more or all of the following: acquiring the plurality of frames; selecting a region of interest having the same coordinates for each of the plurality of frames; averaging the number of pixels within each region of interest to create a raw reference signal; detrending the raw reference signal to create a detrended raw reference signal; performing frequency domain analysis of the detrended raw reference signal; identifying a frequency band of interest associated with the spontaneous hemodynamic oscillations; performing an inverse fast Fourier transform within the frequency band of interest to generate a reference signal including a plurality of samples and indicative of blood volume oscillations at a selected spontaneous hemodynamic oscillation; for each sample of the reference signal at a predetermined point in time, multiplying the sample by each pixel of a frame at the same predetermined point in time to generate a three-dimensional coordinate matrix including a plurality of correlation matrix frames at each predetermined point in time; and/or adding the plurality of correlation matrix frames at each predetermined point in time to generate a two-dimensional hemodynamic map indicative of the strength of the spontaneous hemodynamic oscillation to assess the viability of the tissue and/or the other hemodynamic parameters in the predetermined area..Iaddend.
.Iadd.33. The method of claim 30 in which the other hemodynamic parameters include one or more of: heart rate, resting heart rate, heart rate variability, and tissue saturation for patients suffering from diminished blood circulation..Iaddend.
.Iadd.34. The method of claim 30 in which the spontaneous hemodynamic oscillations have a frequency in the range of 0.05 Hz to about 1.5 Hz..Iaddend.
.Iadd.35. The method of claim 30 in which the predetermined wavelength is in the range of about 500 nm to about 1,000 nm..Iaddend.
.Iadd.36. The method of claim 30 in which the predetermined depth is in the range of about 0.1 mm to about 0.5 mm..Iaddend.
.Iadd.37. The method of claim 30 in which the predetermined area includes a burn area of the human subject..Iaddend.
.Iadd.38. The method of claim 30 in which the predetermined area includes a wound area of a human subject..Iaddend.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
(1) Other objects, features and advantages will occur to those skilled in the art from the following description of a preferred embodiment and the accompanying drawings, in which:
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DETAILED DESCRIPTION OF THE INVENTION
(8) Aside from the preferred embodiment or embodiments disclosed below, this invention is capable of other embodiments and of being practiced or being carried out in various ways. Thus, it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the drawings. If only one embodiment is described herein, the claims hereof are not to be limited to that embodiment. Moreover, the claims hereof are not to be read restrictively unless there is clear and convincing evidence manifesting a certain exclusion, restriction, or disclaimer.
(9)
(10) System 10 also includes one or more polarizers each coupled to one or more light sources.
(11) Polarized light 14.sup.p emitted from each polarizer 22 provides a relatively low-cost solution to enable real-time assessment of the tissue viability and other hemodynamic parameters of tissue 16 in predetermined area 18. As polarized light 14.sup.p transversely propagates through time and space, it contains both oscillating orthogonal electric and magnetic field vectors. The polarization of polarized light 14.sup.p as disclosed herein refers to the direction and manipulation of the oscillating electric field vector. Polarization may be produced and manipulated by polarizer 22 coupled to one or more light sources 12. Polarizer 22 may be placed in any desired position along path of light 14 from detectors 12,
(12) In the example discussed above with reference to
(13) System 10 may also include one or more light filtering lenses coupled to one or more light sources 12, e.g., light filtering lens 46 shown coupled to polarizer 22. Light filtering lens 46 is preferably configured to be transmissive within the desired operating spectrum discussed above and configured to block EM waves outside of the desired spectrum.
(14) System 10 also includes one or more detectors 40,
(15) Each of detector polarizer 42 are configured to discriminate between polarized light 14.sup.pd maintained in the polarized state and at the predetermined depth, d-24, .[.in.]. from tissue 16 and polarized light 14.sup.p reflected from tissue 16 which has not been maintained in the polarized state and at the predetermined depth. For example, as shown generally by arrow 43, each detector polarizer 42 coupled to detector 40 discriminates between polarized light 14.sup.pd that has been maintained in the polarized state at predetermined depth, d-24, in tissue 16 and polarized light 14.sup.p which has not been maintained in the polarized state at predetermined depth, d-24.
(16) One or more detectors 40,
(17) System 10 also includes controller 50,
(18) Controller 50 acquires the plurality of frames 40,
(19) Controller 50 then averages the number of pixels from i=I to i=n within each ROI-52 of each of the plurality of frames 40, at times t.sub.1, t.sub.2, t.sub.3 . . . t.sub.N, indicated at 54, to create raw reference signal 56. In one example, controller 50 uses equation (1) below to averages the number of pixels within each ROI-52:
(20)
where n is the number of pixels in the selected ROI and N is the number of acquired frames.
(21) Controller 50 then detrends raw reference signal 56, indicated at 58, to create detrended raw reference signal 60.
(22) Controller 50 then performs frequency domain analysis of detrended raw reference signal 60 and identifies a frequency band of interest associated with the spontaneous hemodynamic oscillations. In this example, controller 50 has identified the frequency band of interest between F.sub.1-62 and F.sub.2-64 associated with spontaneous hemodynamic oscillations 66. The frequency band of interest associated with the spontaneous hemodynamic oscillations is typically in the range of 0.05 Hz to about 1.0 Hz, as discussed above.
(23) Controller 50 then performs inverse fast Fourier transform (iFFT), indicated at 68, within the frequency band of interest, F.sub.1-62 to F.sub.2-64, to generate reference signal (R.sub.s) 70 indicative of blood volume oscillations at selected hemodynamic oscillations.
(24) For each sample of reference signal 70 at a predetermined point in time, controller 50 multiplies the sample by each pixel of a frame at the same predetermined point in time to generate three-dimensional correlation matrix 72 which includes a plurality of correlation matrix frames 74 at each predetermined point in time. As discussed above, each of the plurality of frames 40 is acquired at a various point of time, e.g., time ranging from t.sub.1, t.sub.2, t.sub.3, . . . t.sub.N. Reference signal 70, shown in greater detail in
(25) In one example, correlation matrix 72 is generated using equation (2):
FRAME.sub.i*R.sub.Si (2)
where FRAME.sub.i is each individual pixels in specific frame at time i, e.g., t.sub.1, t.sub.2, t.sub.3, . . . t.sub.N, and R.sub.Si is a sample at time i of the Reference Signal, e.g., t.sub.1, t.sub.2, t.sub.3, . . . t.sub.N.
(26) Controller 50 then adds the plurality of correlation matrix frames 74 at each predetermined point in time to generate two-dimensional hemodynamic map 100,
(27)
where i is correlation matrix at time, i, e.g., t.sub.1, t.sub.2, t.sub.3, . . . t.sub.N. N is the total amount of is acquired frames, and CMx is the hemodynamic map showing areas of viable tissue.
(28) In one design, system 10,
(29) The result is system 10 provides hemodynamic map 100,
(30) Hemodynamic map 100,
(31) Controller 50,
(32) To reduce and minimize the impact of uncontrolled ambient light changes, system 10 and the method thereof may implement spectral estimation techniques of the ambient illumination to remove uncontrolled ambient light changes. In other designs, system 10 and the method thereof may remove ambient lighting artifacts at the acquisition level by removing temporal changes in ambient illumination measured during programmed periods of non-active tissue illumination.
(33) System 10 also preferably includes user interface 112 coupled to controller 50 electronically or wirelessly which may allow a user of system 10 to visualize and interact with the stored or real-time data. Data may be retrieved from controller 50 and storage device 110 via a data jack or by wireless communication, as known by those skilled in the art. System 10 also includes power supply 116 configured to provide power to one or more light sources 12, one or more detectors 20, controller 50, and/or display device 102. In one design, power supply 116 may include batteries for portable applications.
(34) In other designs, contactless system 10 and method for assessing tissue viability and other hemodynamic parameters may be a standalone device for operation room, a portable device, or integrated into wearable tools wore by medical personnel.
(35) One example of the method for assessing tissue viability and other hemodynamic parameters includes emitting light at a predetermined wavelength sensitive to hemoglobin concentration associated with spontaneous hemodynamic oscillations at tissue in a predetermined area of a human subject, step 150,
(36) The result is system 10 and the method thereof provides a contactless real-time assessment of tissue viability and other hemodynamic parameters that allows a user to quantitatively assess the tissue health to provide objective metrics to support and guide accurate tissue excision of a burn wound or similar type wound. System 10 and the method thereof allows clinicians to selecting a level of debridement of a burn wound at a desired depth to minimize inflammation and determine the optimal treatment and remove virtually all the necrotic tissue in the burn wound or similar type wound in a time efficient manner. System 10 and the method thereof eliminates the need for intrusive tissue contact and preferably provides for long distance tissue viability assessment monitoring when compared to more conventional invasive imaging systems and methods discussed in the Background section. System 10 and the method thereof may provide opportunities in settings where multi-individual assessment may be extremely difficult or not feasible, such as intensive care units, emergency rooms, or where the condition of the patient may not allow for contact measurements.
(37) One advantage of system 10 and the method thereof relying on spontaneous hemodynamic oscillation measurements discussed above with reference to one or more of FIG. 1-6, rather than absolute concentration measurements of chromophores present in the cardiovascular system, is an optical path length factor approximation is not required by system 10 and the method thereof. This may eliminate the need to rely on estimation errors. System 10 and method thereof, unlike conventional near infrared spectroscopy (NIRS) techniques, preferably does not require absolute concentration retrieval of the chromophores present in the cardiovascular system of tissue 16 of predetermined area 18 of human subject 16. Instead, system 10 and the method thereof preferably utilizes controller 50, one or more light sources 12, and one or more detectors 20. In one example.
(38) For enablement purposes only, the following code portions are provided which can be executed on one or more processor, a computing device, or computer to carry out the primary steps and/or functions of contactless system 10 and method for assessing tissue viability and other hemodynamic parameters discussed above with reference to one or more of
(39) TABLE-US-00001 %Acquire image Frame = get frame (n,m) from camera/sensors etc. %Determine ROI (region of interest) maskmother = zeros(n,m) %set to zero a matrix equal to the size of the acquired image % Set to 1 an area of interest where reference signal will be calculated from mask_1 = ones (maskmother (n,m) ) %Average pixels within selected ROI: im = Frame.* mask_1 %Detrend im signal im = im − im_Trend %identify frequency components in im signal by FFT (Fast Fourier Transform) PSD = FFT (im) %Extrapolate Reference Signal by performing Inverse Fourier Transform only between frequency range of interest (for example HR, respiration rate etc.). Discard imaginary part Ref = Real [FFT.sup.−1( PSD(C1<f<C2) )] %Integrate reference signal and acquired images product over time to obtain hemodynamic map (S): S = sum.sub.t (Ref.*Frame)
(40) Although specific features of the invention are shown in some drawings and not in others, this is for convenience only as each feature may be combined with any or all of the other features in accordance with the invention. The words “including”, “comprising”, “having”, and “with” as used herein are to be interpreted broadly and comprehensively and are not limited to any physical interconnection. Moreover, any embodiments disclosed in the subject application are not to be taken as the only possible embodiments.
(41) In addition, any amendment presented during the prosecution of the patent application for this patent is not a disclaimer of any claim element presented in the application as filed: those skilled in the art cannot reasonably be expected to draft a claim that would literally encompass all possible equivalents, many equivalents will be unforeseeable at the time of the amendment and are beyond a fair interpretation of what is to be surrendered (if anything), the rationale underlying the amendment may bear no more than a tangential relation to many equivalents, and/or there are many other reasons the applicants cannot be expected to describe certain insubstantial substitutes for any claim element amended.
(42) Other embodiments will occur to those skilled in the art and are within the following claims.