System and method for non-invasive instantaneous and continuous measurement of cardiac chamber volume

• US 8,463,361 B2
• Filed: 05/23/2008
• Issued: 06/11/2013
• Est. Priority Date: 05/24/2007
• Status: Active Grant

• Current Assignee: LifeWave Biomedical, Inc.
• Original Assignee: LifeWave, Inc.
• Inventors: Tupin, Joe Paul Jr.
• Primary Examiner(s): Casler, Brian
• Assistant Examiner(s): LAURITZEN, AMANDA L
• Application Number:
  US12/601,665
• Publication Number:
  US 20100179421A1
• Time in Patent Office: 1,845 Days
• Field of Search: 600/407, 600/410, 600/411, 600/424, 600/425, 600/427, 600/429, 600/430, 600/437, 600/438, 606/130
• US Class Current: 600/427
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/0507 using microwaves or terahertz waves
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: A61B 6/508 for non-human patients

Abstract

A system and method for non-invasive and continuous measurement of cardiac chamber volume and derivative parameters including stroke volume, cardiac output and ejection fraction comprising an ultrawideband radar system having a transmitting and receiving antenna for applying ultrawideband radio signals to a target area of a subject'"'"'s anatomy wherein the receiving antenna collects and transmits signal returns from the target area which are then delivered to a data processing unit, such as an integrated processor or PDA, having software and hardware used to process the signal returns to produce a value for cardiac stroke volume and changes in cardiac stroke volume supporting multiple diagnostic requirements for emergency response and medical personnel whether located in the battlefield, at a disaster site or at a hospital or other treatment facility.

Claims

1. A method for determining changes in cardiac chamber volume in a body using an ultrawideband (UWB) medical radar transceiver, the UWB medical radar transceiver including a transmitter and a receiver and a signal processor including software elements and a central processing unit, the method comprising:

(a) transmitting from said transceiver a series of electromagnetic pulses into a body such that said electromagnetic impulses encounter a boundary between different biological regions in the body and small amounts of incident energy from said electromagnetic pulses encountering the boundary are reflected back towards said receiver as raw reflections;

(b) capturing said raw reflections and pre-processing them using said receiver wherein said receiver captures a plurality of said raw reflections using a high speed sample and hold circuit where capture time for a sample of said raw reflections is set equal to a round trip time of flight from said transmitter to one or more depth ranges of interest and back to said receiver;

(c) integrating said plurality of sampled reflections from said depth ranges of interest to form an integrated signal;

(d) filtering said integrated signal to minimize irrelevant high frequency noise so as to avoid corruption of desired data related to tracking instantaneous cardiac chamber volume;

(e) amplifying said integrated signal and passing said signal through a low-pass filter to prevent signal aliasing prior to digitization;

(f) collecting and integrating a predetermined number of reflections for a first range of interest

(g) changing said receiver sample timing and capturing reflections from a next range of interest

(h) repeating (a) through (g) until reflections from an entire range of interest across the cardiac chamber are collected;

(i) continually repeating (h) to deliver an updated instantaneous measure of cardiac volumetric changes.

2. The method according to claim 1 wherein said boundaries within a target range of interest move with respect to placement of said transceiver'"'"'s antenna, producing a complex series of time-varying reflections, and wherein said complex series of time-varying reflections are continually processed by said signal processor to extract information on the mechanical activity of the heart.

3. The method according to according to claim 2 wherein said signal processor and central processing unit provide calculation of cardiac chamber volume via the additional steps of:

range aligning said reflections on sweep boundaries;

said range-aligned reflections are passed through one or more filters to minimize low frequency noise and static clutter;

amplifying and coarse quantitized resultant data associated with all anatomical motion in said range of interest, including cardiac and pulmonary motion, using a binary quantizer where the quantizer threshold for a given sweep or row is based on the median value of the resultant data set, resulting in an intermediate black and white image,

further refining said intermediate image through the application of one or more 1-dimensional or 2-dimensional filters to remove random speckle noise and increase the sharpness of the image boundary edges, to improve accuracy of measurement of spatial changes in the target range of interest, thereby presenting an image space comprised of various spatial structures changing in time representing both heart wall motion and various noise sources including organs, bones, and stray radiofrequency emissions.

4. The method according to claim 3 wherein said data is further refined via the application of at least one additional metric to delineate and confirm that said spatial structures found in said image space are cardiac wall excursions.

5. The method according to claim 4 wherein said at least one additional metric is cardiac rate wherein the cardiac rate is integrated within said signal processor and is detected via application and processing of said electromagnetic signals, said signal processor calculating the cardiac rate via conversion of an entire swept image space to a predetermined frequency domain using an algorithm, wherein said algorithm identifies and isolates an image region of said entire swept image space containing a strongest cardiac signal, while simultaneously determining a range of depth containing said strongest cardiac signal, wherein said cardiac signal depth and said cardiac signal is used to determine one or more additional metrics.

6. The method according to claim 4 wherein said at least one additional metric is cardiac structure completeness comprising the identification and verification of completeness of a target cardiac structure as said target cardiac structure changes over time by evaluating sustained and rhythmic behavior of said target cardiac structure, wherein said signal processor and said central processing unit in conjunction with said software identifies qualifying signals for further analysis by capturing and prioritizing those said qualifying signals with respect to minimum discontinuities, wherein a conversion process includes a chain coding technique in conjunction with at least one structural morphological technique to minimize signal discontinuities caused by noise loss.

7. The method according to claim 4 wherein said at least one additional metric is the continual and repeated identification and tracking of an ellipsoid characteristic in said image space wherein said ellipsoid characteristic best characterizes the approximate motion of anterior and posterior cardiac walls through time, and, wherein a corollary component of said identification and tracking of said ellipsoid characteristic is the isolation and avoidance of signals having a non-ellipsoid characteristic, wherein said non-ellipsoid signals indicate the likely presence of a non-cardiac signal source.

8. The method according to claim 4 wherein said at least one additional metric is the development of a correlation between the time-domain characteristics of an isolated cardiac range bin identified by a first cardiac rate metric with points identified in said image space that represent minimum, maximum, and zero-crossing points of cardiac wall excursions in said image space as identified by a second and a third metric.

9. The method according to claim 3 wherein said data is further refined via the application of at least one additional metric to delineate and confirm that said spatial structures found in said image space are cardiac wall excursions and not caused by other signal sources, and wherein image regions that meet the requirements of said at least one additional metric are isolated and identified as qualifying candidates for further analysis wherein a likely image region providing a most probable representation of instantaneous cardiac volume is an image region having the strongest characteristic in said at least one additional metric.

10. The method according to claim 9 wherein said likely image region is chosen, minimum and maximum cardiac wall excursions are identified and quantified using prior data acquired and already available from assessment of at least one additional metric, and wherein actual chamber wall displacement is calculated using said minimum and maximum cardiac wall excursions by counting spatial pixels traversed from a minimum point to a maximum point of the cardiac waveform to determine a count of spatial pixels traversed and multiplying said count of pixels by a resolution of the data capture device.

11. The method according to claim 10 wherein instantaneous cardiac volume is determined by the additional step of applying presumed dimensions of the target cardiac chamber in conjunction with said minimum and maximum cardiac wall excursions to determine volumetric changes in the target heart chamber.

12. The method according to claim 11 wherein said presumed dimensions of the target cardiac chamber are represented by one or more different shapes, wherein said shapes determine accuracy of calculated chamber volume and derivative stroke volume.

13. The method according to claim 12 wherein one of said one or more different shapes is a simplified sphere.

14. The method according to claim 12 wherein one of said one or more different shapes is an asymmetric changing ellipsoid.

15. The method according to claim 12 wherein one of said one or more different shapes is the actual shape of the cardiac chamber as determined by other precursor imaging and sizing methods, including x-ray, magnetic resonance imaging, ultrasound, surgery or other similar methods capable of determining dimensions of the target cardiac chamber.

16. The method according to claim 12 further including the additional steps of determining one or more cardiac performance parameters.

17. The method according to claim 16 wherein one of said one or more cardiac performance parameters is stroke volume, said stroke volume calculated by taking a difference between a maximum chamber volume and a minimum chamber volume on a beat-by-beat basis.

18. The method according to claim 17 wherein another one of said one or more cardiac performance parameters is cardiac output, said cardiac output calculated by multiplying said stroke volume by the heart rate.

19. The method according to claim 17 wherein another one of said one or more cardiac performance parameters is ejection fraction, said ejection fraction calculated by dividing said stroke volume by a maximum chamber volume.