Device and system for remote for in-clinic trans-abdominal/vaginal/cervical acquisition, and detection, analysis, and communication of maternal uterine and maternal and fetal cardiac and fetal brain activity from electrical signals
First Claim
1. A method for characterizing uterine electrical activity, comprising:
- a. applying an action potential measuring multi-polar arrangement of electrodes to an abdominal, vaginal or cervical surface of a patient;
b. isolating a system from the patient for analog filtering and amplifying an electrical signal as appropriate to isolate desired frequency components of said signal from background noise in said signal;
c. acquiring analog electrical uterine, maternal or fetal cardiac signals, fetal brain signals, or a combination thereof transmitted through said electrodes at a sampling frequency between about 0.5 and 1 kHz for a duration of time sufficient to record at least 3 bursts of action electrical potentials from said signals;
d. removing unwanted signal components through a multi-channel noise elimination scheme;
e. storing said acquired signals;
f. using detection algorithms to detect one or more attributes of said uterine, maternal or fetal cardiac activity, fetal brain activity, or combination thereof that are present in said acquired signals;
g. analyzing at least a portion of said activity, indicating parameters from at least one burst of the action potentials within the stored signals;
h. characterizing said activity from said patient based on said parameter analysis;
i. determining electrically when contractions occur and plotting the contractions;
j. simulating data output of a tocodynamometer or an intra-uterine pressure catheter; and
k. predicting when a patient will go into labor or delivery, or a combination thereof.
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Abstract
The present invention presents a method and apparatus for recording and analyzing uterine electrical activity, or electromyography (EMG), from the surface of the abdomen, vagina, or cervix of a patient for the purpose of diagnosing contractile patterns of the uterus in pregnant and non-pregnant women, as well as for monitoring maternal and fetal ECG and fetal brain activity. The method and apparatus described include methods for the systematic detection, analysis, characterization and communication of information about electrical signals recorded from the abdominal/vaginal/cervical surface. The present invention provides data analysis techniques for analyzing the electrical data measured from the surface of a patient to characterize their uterine, abdominal, and cardiac muscle activity, as well as cardiac and brain activity of the fetus simultaneously or separately. These techniques and apparatus are appropriate for use in a clinic or through landline or wireless communication for use as a remote or home uterine/fetal monitoring system.
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Citations
47 Claims
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1. A method for characterizing uterine electrical activity, comprising:
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a. applying an action potential measuring multi-polar arrangement of electrodes to an abdominal, vaginal or cervical surface of a patient;
b. isolating a system from the patient for analog filtering and amplifying an electrical signal as appropriate to isolate desired frequency components of said signal from background noise in said signal;
c. acquiring analog electrical uterine, maternal or fetal cardiac signals, fetal brain signals, or a combination thereof transmitted through said electrodes at a sampling frequency between about 0.5 and 1 kHz for a duration of time sufficient to record at least 3 bursts of action electrical potentials from said signals;
d. removing unwanted signal components through a multi-channel noise elimination scheme;
e. storing said acquired signals;
f. using detection algorithms to detect one or more attributes of said uterine, maternal or fetal cardiac activity, fetal brain activity, or combination thereof that are present in said acquired signals;
g. analyzing at least a portion of said activity, indicating parameters from at least one burst of the action potentials within the stored signals;
h. characterizing said activity from said patient based on said parameter analysis;
i. determining electrically when contractions occur and plotting the contractions;
j. simulating data output of a tocodynamometer or an intra-uterine pressure catheter; and
k. predicting when a patient will go into labor or delivery, or a combination thereof. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. A system for recording and analyzing uterine electrical activity for the abdominal, cervical or vaginal surface, comprising:
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a. an arrangement of at least three electrodes forming a multi-polar arrangement adapted to measure electrical signals due to action potentials emitted from an abdominal, vaginal, or cervical surface of a patient under analysis to establish uterine, maternal and fetal cardiac, and fetal brain signals and each electrode further adapted to conduct an analog signal indicative of said action potentials, each electrode-pair being identified with one channel of data;
b. at least one analog filter adapted to remove unwanted signal components from the uterine, maternal and fetal cardiac, and fetal brain signals;
c. at least one differential, isolated, analog amplifier electrically coupled to said electrodes to receive and amplify signals indicative of said action potentials measured by said electrodes;
d. at least one analog to digital converter adapted to generate digital signals from the analog signals produced by the amplifiers;
e. at least one memory comprising sufficient storage capacity to store data resulting from a sampling of electrical signals at a sampling frequency of at least 100 Hz from a single patient for at least 1 hour, said memory adapted to receive a digital input from said analog to digital converter;
f. a computer programmed to import electrical signal data from multiple channels, or multiple differential signals from multiple electrode-pairs, formed from an array of said multi-polar arrangement of electrodes, and to perform mathematical functions on at least two of the potentials measured to generate multiple channels of data which are the result of at least one mathematical combination of said potentials from said mathematical functions;
g. said computer programmed to perform multi-channel filtering on at least one of the channels of data to remove unwanted noise components common to one or more channels;
h. said computer programmed to analyze frequency, duration, amplitude, power density spectrum, wavelet transforms, Fourier transforms, rate of rise and fall of signals, spectral-temporal mapping, complexity, chaos, fractals, zero-crossings, randomness, non-linearity, likelihood ratios, statistical evaluations, Wigner-Ville or Heisenberg-Gabor analysis, or other joint time-frequency analysis on the uterine, cardiac, and brain signals acquired, said computer further being adapted to characterize uterine, maternal and fetal cardiac, and fetal brain activity based upon said analysis. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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43. A remote uterine monitoring system for remotely characterizing uterine activity, comprising:
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a. at least three electrodes forming a multi-polar arrangement adapted to measure electrical signals of action potentials emitted from an abdominal, vaginal, or cervical surface of a patient under analysis and further adapted to emit an analog signal indicative of action potentials measured by said electrodes;
b. an isolation system comprising analog filters adapted to remove unwanted signal components from the uterine, maternal and fetal cardiac, and fetal brain signals;
c. at least one analog differential amplifier coupled to said electrodes, isolated from the patient optically, electrically, or by other standard means, and adapted to receive and amplify signals indicative of action potentials measured by said electrodes;
d. at least one analog to digital converter adapted to produce digital signals from the analog signals produced by the amplifiers;
e. a computer programmed to import electrical signal data from multiple channels, or multiple differential signals from multiple electrode-pairs, formed from an array of said multi-polar arrangement of electrodes, and to perform mathematical functions on two or more of the channels to generate channels of data, which are the result of such mathematical combination of said potentials;
f. said computer adapted to perform multi-channel filtering on said channels of data to remove unwanted noise components common to one or more channels;
g. said computer programmed to analyze the frequency, duration, amplitude, power density spectrum, wavelet transforms, Fourier transforms, rate of rise and fall of signals, spectral-temporal mapping, complexity, chaos, fractals, zero-crossings, randomness, non-linearity, likelihood ratios, statistical evaluations, Wigner-Ville or Heisenberg-Gabor analysis, or other joint time-frequency analysis on the uterine, cardiac, and brain signals acquired, said expert system further being adapted to characterize maternal uterine, maternal and fetal cardiac, and fetal brain activity based upon said analysis;
h. at least one data transmission system, coupled to said computer, adapted to transmit uterine, maternal and fetal cardiac, and fetal brain signals, processed or unprocessed, to a remote location from said computer via a telecommunications link;
i. at least one remote analog to digital converter coupled to said data transmission system to receive an analog input from said amplifier indicative of action potentials measured by said electrodes;
j. at least one memory comprising sufficient storage capacity to store data resulting from a sampling of trans-abdominal, trans-vaginal, trans-cervical electrical signals, or a combination thereof, at a sampling frequency of at least 100 Hz from a single patient for at least 1 hour, said memory adapted to receive a digital input from said analog to digital converter indicative of action potential signals received by said converter;
k. at least one receiver adapted to collect the uterine, cardiac, or brain data, processed or unprocessed, which is transmitted from said computer at the site of the patient; and
l. at least one remote computer located remote from the patient and coupled to said receiver to import received data from the site of the patient and programmed to analyze the frequency, duration, amplitude, power density spectrum, wavelet transforms, Fourier transforms, rate of rise and fall of signals, spectral-temporal mapping, complexity, chaos, fractals, zero-crossings, randomness, non-linearity, likelihood ratios, statistical evaluations, Wigner-Ville or Heisenberg-Gabor analysis, or other joint time-frequency analysis on the uterine, cardiac, and brain signals acquired, said remote computer further being capable of characterizing maternal uterine, maternal and fetal cardiac, and fetal brain activity based upon said analysis. - View Dependent Claims (44, 45, 46, 47)
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Specification