Abstract:
Remote monitoring of biological signals such as ECG waveforms, in which an FM encoded version of an ECG waveform is transmitted from a patient&#39;s home to a central station where it is analyzed to estimate local frequencies at many more time points than the zero crossovers of the FM signal. A plurality of ECG waveforms is encoded in a composite FM signal any one point of which can represent at the same time a number of ECG waveforms. The composite waveform is analyzed at the central station to extract and reconstruct the individual waveforms by separation in the frequency domain.

Description:
FIELD 
     This patent specification is in the field of remote monitoring of biomedical data, such as ECG (electrocardiographam) data. 
     BACKGROUND 
     Transtelephonic monitoring of cardiographic data such as ECG waveforms and heart pacer information has been used for many years. Typically, a cardiac transducer at a patient&#39;s home produces an electrical ECG signal in the form of a voltage across a pair of ECG pads that are in electrical contact with the patient&#39;s body. The resulting ECG waveform is used to frequency modulate a carrier, and the resulting FM signal drives a speaker producing an acoustic FM signal played into the mouthpiece of a telephone receiver that converts the acoustic signal back to an electrical FM signal. Via the telephone network, a central station receives the transmitted signal and processes it to reconstruct, display, and record the ECG waveform or to extract other information. If the cardiac signal is pacer related, the information of interest could be the duration of a pacer pulse or the time between pulses. The conversion to an acoustic signal and back to an electrical signal can be avoided if the patient has suitable equipment and skill for the purpose. Examples of transtelephonic monitoring of cardiac information can be found in U.S. Pat. Nos. 4,938,229 and 5,467,773 (each incorporated by reference herein), and 5,735,285, as well as in references cited in said patents. 
     The assignee of this patent specification supplies such equipment and services, described further at its Website. Typically, information from different ECG pads or combinations of pads (vectors), or from a pacer, is embedded in the FM signal serially, and packets of additional information such as device ID and time stamps usually are inserted. Only one ECG waveform, or only one pacer pulse, or only one item of identifying information, modulates the carrier at any one time. It is believed that several years ago an entity called the Cardiac Evaluation Center in Milwaukee, Wis. offered, and may still be offering, a two-channel transmitter and a proprietary receiver, encoding two ECG waveforms at the same time into a single FM signal that is separated at a proprietary receiver believed to have used analog bandpass filters for the separation. It is not known what technique that system used to demodulate the FM signal. 
     In the two patents incorporated by reference herein, the FM signal was demodulated at the receiving station to extract the ECG waveform by finding the zero crossings of the FM signal and measuring the time between those zero crossings. In particular, the patented systems counted a clock during the intervals between adjacent zero crossings and converted the counts to frequency, thereby reconstructing the original ECG waveform. U.S. Pat. No. 5,735,285 is understood to propose another zero crossing detection technique, involving an examination of the area where digitized samples of the FM signal transition between positive and negative values. While such zero crossing analysis of the FM signal, with appropriate suppression of noise and other sources of inaccuracies, has been used for years, it is believed that a need still remains for: (1) a more accurate and reliable reconstruction of the original ECG waveform; (2) the simultaneous transmission of multiple ECG waveforms or other information coupled with such more accurate and reliable reconstruction of the original information; and (3) such simultaneous transmission demodulated at the receiving station using a general purpose computer that can be conveniently adapted through programming to different formats of information transmission and can be less costly and more acceptable than proprietary hardware. 
     SUMMARY 
     This patent specification discloses a system and a method for remotely monitoring, at a central station, cardiac conditions existing at a remote station. In a preferred embodiment, three or more ECG waveforms are derived from a patient at a local station. These ECG waveforms frequency modulate respective different carriers to thereby produce three or more respective FM signals. These FM signals are combined into a composite FM signal containing concurrent information from the three or more ECG waveforms, and are transmitted to a central station. At the central station, the received composite FM signal is processed both in the time domain and in the frequency domain to reconstruct the three or more individual ECG waveforms in a manner that comprises estimating local frequencies at portions of the composite FM signal that are substantially closer to each other than zero crossovers of the composite FM signal. The process calculates local phase differences and uses them to estimate said local frequencies. The local phase differences are calculated by combining digital samples of the composite FM signal with a phase shifted version of the digital samples. 
    
    
     BRIEF DESCRIPTION OF THE DRAWING 
     The FIGURE illustrates a system embodying a preferred example of the disclosure. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Cardiac ECG Event Monitors, Loop Recorders and Post Event Recorders are examples of sensor/transmitters used at a remote location such as a patient&#39;s home. Multi-channel sensor/transmitters produce several channels of ECG waveforms, e.g., from different combinations of ECG pads. One known pattern is to use three ECG waveforms derived from differences between signals from three pairings of ECG pads (three vectors). In a preferred embodiment, the system described herein simultaneously encodes the three ECG waveforms into a single FM signal at the remote location, and reconstructs the ECG waveforms at a receiving station using techniques more reliable than zero crossing detection. In the preferred embodiment, the reconstruction of the ECG waveforms is implemented solely through a general purpose computer, such as a PC, running suitable utility and application programs. While the detailed description below uses the example of three ECG waveforms simultaneously encoded into a single FM signal, in its general form the disclosure herein is applicable to N waveforms, where N≧2, and to biomedical signals in addition to ECG waveforms. In addition, the techniques disclosed herein for reconstructing a waveform more reliably than when using zero crossing detection are applicable to the case where only a single waveform is encoded in the FM signal. 
     At the transmitting end (typically the patient&#39;s home), the patient uses a sensor/transmitter that is otherwise similar in FM encoding technique to those currently supplied by the assignee hereof but FM encodes each of three ECG waveforms into a respective channel and then sums the three FM encoded channels into a single, composite FM signal. For example, a first ECG channel FM modulates a 1700 Hz carrier in a frequency band of 1500-1900 Hz for a first channel of ECG data, a second ECG channel uses a 1950-2350 Hz band on a 2150 Hz carrier, and a third ECG channel uses a 2400-2800 Hz band on a 2600 Hz carrier. The resulting three FM signals are summed into a composite FM signal that is transmitted to the central station. Additional data such as, without limitation, an ID of the transmitting device, pacemaker pulse measurements, and time stamps, can be embedded in the composite FM signal, such as by the known and long used techniques of shifting frequency for several milliseconds out of a signal band frequency, thus indicating the presence of binary data in the FM analog signal. The transmission can be by first converting the composite FM signal into an acoustic signal by a speaker at the sensor/transmitter and playing the acoustic signal into the receiver of a telephone connected over the public telephone system to the central or receiving station, or a direct electrical transmission can be used that does not go through an audio stage. 
     At the central station, the composite FM signal received over the telephone line is supplied to a general purpose digital computer such as a PC with a sound card, and is analyzed to extract the information defining the three ECG channels, as well as additional information that may have been encoded therein. In principle, the process carried out at the central station converts the received composite FM signal to digital samples x(t), separates them into frequency bands matching the individual FM signals, finds for each band the difference in instantaneous frequency between adjacent digital samples, and uses these frequency differences to reconstruct the original ECG waveforms and any other data of interest. 
     Referring to FIG. 1 for an illustration of a system using an embodiment disclosed herein, ECG pads  10  used as known at a remote location such as a patient&#39;s home generate three channels or vectors of ECG analog waveforms. A local transmitter  11  comprises FM encoders  12 - 1 ,  12 - 2 , and  12 - 3  each encoding a respective channel of ECD data into a frequency modulated analog waveform in a respective frequency band. Local transmitter  11  also includes a summing device  14  which combines the three FM channels into a single, composite FM signals. If a pacer  16  is used, summing device  14  may embed pacer-related information in the composite FM signal as known in the art. Further as known in the art, summing device  14  may embed in the composite FM signal other information such as an ID of the local transmitter, a time stamp, etc. A speaker  18  at the remote location converts the composite FM signal into an audio signal which a receiver of a remote location telephone  20  converts back to a composite, analog electrical FM signal. This FM signal is transmitted through the public telephone switching system, or through some other communication link, to a central station for analysis and recording. If special equipment and skills are available at the remote location, the conversion to an audio signal and back to an analog electrical signal can be avoided, and the composite FM signal from summing device  14  can be transmitted directly to the central station using a suitable communication link. 
     At the central location, a telephone unit  30  receives the composite FM signals and supplies it to a suitably programmed general purpose computer such as PC with a sound card. Using the sound card as an ADC (analog-to-digital converter)  32 , the central station converts the received composite FM signal to arrays of time domain digital samples x(t), which an FFT (Fast Fourier Transform) analyzer  34  converts to arrays of frequency domain digital samples fft(t). These samples fft(t) are separated into three bands, corresponding to the three channels of ECG information, at bandpass filters  36 - 1 ,  36 - 2 , and  36 - 3 , and the output of each bandpass filter is subjected to IFFT (Inverse Fast Fourier Transform) analysis at a respective one of analyzers  38 - 1 ,  38 - 2 , and  38 - 3 . A unit  40  receives the output of these analyzers and reconstructs, records and displays the three ECG waveforms. If additional information, such as pacer information is embedded in the composite FM signals, a pacer analyzer  42  extracts it and supplies it to unit  40  for display and recording. The equipment at the central station can be, and in a preferred embodiment is, implemented by programming a PC. As earlier noted, conventional PC sound card hardware and utilities of a PC are used to digitize the composite FM signal. FFT analyzer  34  can be implemented by using an off-the-shelf FFT program. Bandpass filters  36  can be implemented by nulling certain frequency bins as discussed below. IFFT analyzers  38  can be implemented by using off-the-shelf IFFT and Hilbert transform programs. Pacer analyzer  42  can be implemented as known in the art and used by the assignee hereof for years for single channel ECG data. Finally, unit  40  can be implemented using the conventional data storage and display capacities of a PC. 
     In an alternative embodiment, the path starting with remote location telephone set  20  and ending with central station telephone set  30  can be replaced by a microphone  31  that is sufficiently close to speaker  18  to convert the sound from speaker  18  into an analog electrical signal, which analog signal is then supplied to ADC  32 . As a further alternative (not illustrated in the drawing), the analog electrical signal from summing circuit  14  can be supplied directly to ADC  32 , thereby eliminating the path starting with speaker  18  and ending with central station telephone set  30 . 
     In an exemplary and non-limiting example disclosed herein, the process as applied to ECG vectors includes the following main steps that are computer-implemented using a PC with a sound card and suitable programming: 
     1. At the patient&#39;s home, or another remote or transmitting location, obtain three ECG channels (vectors), each in the form of a respective ECG electrical waveform. This can be done using currently commercially available equipment, for example equipment available from the assignee hereon; 
     2. Use each ECG vector to frequency modulate a respective carrier to thereby generate three FM ECG signals, each in a respective frequency band, e.g. a carrier frequency of 1700 Hz and bandwidth of 1500-1900 Hz for channel  1 , a carrier frequency of 2150 Hz and bandwidth of 1950-2350 Hz for channel  2 , and a carrier frequency of 2600 Hz and bandwidth of 2400-2800 Hz for channel  3 . The encoding for each individual channel can also be done using equipment currently available commercially, for example from the assignee hereof; 
     3. Sum the three FM ECG signals into a single, composite FM signal. This can be done using an analog summing circuit, for example currently commercially available circuits of this type; 
     4. Convert the composite FM signals into an audio signal. This can be done using a speaker, such as in currently commercially available home transmitter, such as those available from the assignee hereof; 
     5. Convert the audio signal back to a composite FM signal and transmit as such to a central station. This can be done using a telephone set at the patient&#39;s home, such as described in the patents incorporated by reference herein; 
     6. Digitize the composite FM signal received at the central station into arrays of time domain digital samples x(t). This can be done using the sound card of a conventional PC. The preferred format is to digitize the incoming composite FM signals at sampling rate of 8 Khz (8,000 samples per second), into arrays of 1024 samples each, overlapped by 512 samples, i.e., the first 512 samples of the second array are the same as the last 512 samples of the first array, etc. Each sample is 16 bits long, representing the instantaneous amplitude (x) of the composite FM signal at a respective time (t). The result is a succession of arrays of 1024, 16-bit values each, overlapped by 512 samples. For computational convenience in a preferred embodiment, the arrays are converted to single precision arrays: 
     7. Filter the digital samples x(t) to reduce noise, e.g., with a Hamming Window filter. This can be done using an off-the-shelf utility for Hamming Window filtering in a PC; 
     8. Pass the arrays of digital samples x(t) through an FFT (Fast Fourier Transform) Analyzer to convert them into frequency domain digital sample arrays fft(t), where each sample is a value of a coefficients of a Fourier series representation of the x(t) arrays. This can be done using an off-the-shelf FFT program running in a PC. The result is the conversion of each of the 1024-element x(t) array into a corresponding 1025-element, complex-conjugate symmetric fft(t) array. The elements of the fft(t) array are related to the values of coefficients for respective frequencies, and are stored in respective frequency bins in PC memory. Additional filtering can be done at this point to null coefficient values for frequencies outside the bandwidths of the three ECG signals. For example, a bandpass filter of 750-3250 Hz can be applied by zeroing frequency bins corresponding to 0 Hz, 7.8125 Hz, 15.625 Hz, . . . , 742.1875 Hz (i.e., elements 1-95 inclusive of each fft(t) array), and bins corresponding to 3257.8125 Hz, 3265.625 Hz, . . . 4000 Hz (i.e., elements 417-513 of each fft(t) array); 
     9. Separate the samples fft(t) into respective spectral bands each matching the frequency band of a respective one of the ECG channels that were FM encoded at the remote location (the patient&#39;s home). This can be done by making three copies of the (filtered) fft(t) array and in each nulling the elements that correspond to frequencies outside the frequency band of the respective ECG signal; 
     10. Pass the samples fft(t) through IFFT (Inverse Fast Fourier Transform) and Hilbert transform analysis to obtain arrays of digital samples of an analytical signal z(t), where each z(t) sample has a real part matching the time domain samples x(t) of the composite FM signal and an imaginary part jh(t) that matches a Hilbert transform of x(t), according to the expressions: 
     
       
           z ( t ) =ifft [B ( i ){circle around (×)} fft ( t )]= x ( t )+ jh ( t ) 
       
     
      Where: 
     ifft denotes an Inverse Fourier Transform, 
     B(i)=2 for i=[0, N/(2−1)], 
     B(i)=0 for i=[N/2, N−1], 
     i denotes an element of an fft(t) array of N elements, 
     {circle around (×)} denotes conjugate, 
     fft denotes Fast Fourier Transform, 
     j denotes an imaginary part, and 
     h(t) denotes a Hilbert transform of an array x(t). 
      This can be done by using off-the-shelf Hilbert Transform and IFFT programs run on a PC. As evident from the expression above, the Hilbert Transform involves zeroing the coefficient values in all the negative frequency bins of the fft(t) arrays (i.e., array elements 514-1025, inclusive) and doubling the coefficient values in all the positive frequency bins of the fft(t) arrays (i.e., elements 1-513, inclusive). The result is subjected to IFFT, converting each fft(t) array (that has been Hilbert-transformed) into a 1024-element complex array z(t) in which: (1) the real portion contains the original data x(t) enhanced by the windowing and filtering described above, and (2) the imaginary portion contains the Hilbert transform of the same original data. 
     11. Find an instantaneous phase angle p(t) for each sample position of x(t) in accordance with: 
     
       
           p ( t )= a tan [ h ( t )]/ [x ( t )]=tan −1   [h ( t )]/ [x ( t )]. 
       
     
      This can be done by programming a PC to carry out the division and the trigonometric calculation set forth immediately above for each of the time samples (t). The result is a phase angle value p(t) for each instant (t) at which the composite FM signals was sampled to generate to arrays x(t); 
     12. Find the instantaneous frequency f(t) for each sample position of x(t) in accordance with: 
     
       
           f ( t )=[½ π]{[dp ( t )]/ [dt]}=[ ½ π]{[Δp ( t )]/[ Δt]},   
       
     
     Where Δp(t) is the difference in value between two adjacent samples on the instantaneous phase angle p(t), and Δt is the time spacing between two adjacent samples of x(t). 
      This can be done by programming a PC to carry out the arithmetic operations set forth immediately above for each pair of adjacent values of p(t) and (t), in effect producing an 1024-element array of instantaneous frequency values f(t) for each array x(t); 
     13. Convert the instantaneous frequencies f(t) to amplitudes of samples of reconstructed ECG waveform (using 56 sample moving average) to get 14-bit long, averaged, reconstructed ECG samples. This can be done by first discarding the first and last 25% of each array f(t) (because of the large attenuation in these portions of the arrays due to the Hamming Window filtering earlier). Because of the 50% overlap of the x(t) arrays described earlier, the elements discarded from one array f(t) is present in the preceding and succeeding array, so this process still derives an instantaneous frequency f(t) for each instant in which the composite FM signals was sampled. The purpose of using a moving average of 56 samples of f(t) is to reduce the influence of noise or other artifacts. The result is a string of averaged values of frequency at a rate of 142.85714 Hz (i.e., the original sampling rate of 8,000 Hz divided by 56, the number of samples used in averaging). For computational convenience, the resulting values can be multiplied by 5 and converted to integer form, to produce a string of 14-bit values representing the instantaneous frequencies at respective 1/142.85714 time slots in the respective ECG signals; 
     14. Edge detect for FSK/pacer pulse analysis, and encode result into 2-bit encoder data. This can be done as currently carried out in commercial equipment available, for example, from the assignee hereof. In principle, the process involves detecting high-frequency, high-amplitude edges in the composite FM signal, carrying FSK (frequency shift key)/pacer pulse analysis, and encoding detected FSK/pacer pulse data as successive 2-bit values; 
     15. Format the resulting data into 16-bit samples at 142.85714 Hz, where the top two bits are FSK/pacer data of which 20 bits are stored across ten 16-bit samples; 
     16. Display/record the reconstructed ECG and any other relevant data. This can be done using frequency to amplitude conversion techniques as currently used commercially, for example by the assignee hereof, and as described in the patents incorporated by reference herein for single-channel ECG data, adapted to displaying three-channel data in this case.