Disposable fetal monitor patch
First Claim
1. A non-invasive integrated fetal monitor device for obtaining vital signs of a fetus, comprising:
- at least one electrode for contacting the surface of the skin of a pregnant mother at or near her abdomen, said at least one electrode receiving a surface potential of a fetal ECG signal, wherein said fetal ECG signal is contaminated with a maternal ECG signal;
an amplifier for amplifying said ECG signals from said at least one electrode;
a processor for performing real-time processing and analysis of said amplified ECG signals;
a power source for powering said fetal monitor device;
a thin flexible substrate for housing said amplifier, said processor, said at least one electrode, and said power source; and
means for extracting filtered fetal ECG data, relatively free from maternal ECG components, from said amplified ECG signals.
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Accused Products
Abstract
The invention provides a low cost, fully integrated, disposable patch for the non-invasive, continuous monitoring of fetal electrocardiogram (ECG). The patch detects fetal ECG by filtering the dominant maternal ECG therefrom. In one embodiment, an upper electrode is used to obtain a relatively pure maternal ECG signal for its cancellation from the signal obtained from the abdominal fetal ECG. In another embodiment, multiple abdominal electrodes are used and the dominant periodic features of maternal ECG are identified and eliminated. The fetal monitor patch is thin, flexible, and incorporates a battery and an alarm within. The alarm is activated during an adverse health condition for the fetus. The fetal monitor patch is particularly designed for long-term wear applications exceeding one week and lasting up to several months. The patch is unobtrusive and thus worn continuously, even during sleep and bathing. In another embodiment, the fetal monitor patch is programmable and stored fetal ECG data can be transmitted to a remote receiver.
226 Citations
51 Claims
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1. A non-invasive integrated fetal monitor device for obtaining vital signs of a fetus, comprising:
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at least one electrode for contacting the surface of the skin of a pregnant mother at or near her abdomen, said at least one electrode receiving a surface potential of a fetal ECG signal, wherein said fetal ECG signal is contaminated with a maternal ECG signal;
an amplifier for amplifying said ECG signals from said at least one electrode;
a processor for performing real-time processing and analysis of said amplified ECG signals;
a power source for powering said fetal monitor device;
a thin flexible substrate for housing said amplifier, said processor, said at least one electrode, and said power source; and
means for extracting filtered fetal ECG data, relatively free from maternal ECG components, from said amplified ECG signals. - 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, 32, 33, 34, 35, 36)
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37. A programmable, non-invasive fetal monitor patch for monitoring vital signs of a fetus, comprising:
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at least one electrode for contacting the surface of the skin of a pregnant mother at or near her abdomen, said at least one electrode receiving a surface potential of a fetal ECG signal, wherein said fetal ECG signal is contaminated with a maternal ECG signal;
an ECG amplifier connected to said at least one electrode;
a processor;
a power source;
a wireless sensor element for receiving wireless commands from an external programming unit;
a thin, flexible substrate for housing said ECG amplifier, said processor, said at least one electrode, said power source, and said wireless sensor element;
means for extracting a filtered fetal ECG and for removing a maternal ECG component therefrom; and
means for configuring operation of said processor responsive to wireless commands received by said wireless sensor element from said external programming unit. - View Dependent Claims (38, 39, 40)
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41. A non-invasive, fetal monitor patch for monitoring vital signs of the fetus, comprising;
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at least one electrode for contacting the surface of the skin of a pregnant mother at or near her abdomen, said at least one electrode receiving a surface potential of a fetal ECG signal, wherein said fetal ECG signal is contaminated with a maternal ECG signal;
an ECG amplifier connected to said at least one electrode;
a processor for receiving amplified ECG signals;
a power source for powering said fetal monitor device;
a flexible substrate for housing said ECG amplifier, said processor, said at least one electrode, and said power source;
means for extracting a filtered fetal ECG and for removing a maternal ECG component therefrom;
a memory for storing fetal ECG data therein; and
means for transmitting stored fetal ECG data from said memory to a remote instrument. - View Dependent Claims (42, 43)
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44. A method of non-invasive fetal monitoring, comprising the steps of;
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adhesively attaching a patch on the abdomen area of a pregnant woman, said patch comprising a thin flexible substrate, an ECG amplifier, a processor, at least one electrode contacting the skin of the pregnant woman in her abdomen area, a power source, and an alarm indicator;
amplifying a fetal ECG signal obtained from said at least one electrode, said fetal ECG signal being contaminated with a maternal ECG signal;
converting an amplified fetal ECG signal to fetal ECG data contaminated with maternal ECG data;
extracting filtered fetal ECG data from said amplified fetal ECG signal by removing said maternal ECG data therefrom;
computing at least one vital sign for said fetus from said filtered fetal ECG data; and
activating said alarm indicator automatically if said at least one vital sign is outside a predetermined limit. - View Dependent Claims (45, 46, 47)
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48. A method of non-invasive fetal monitoring, comprising the steps of;
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adhesively attaching a fetal monitor patch on an abdomen area of a pregnant woman, said patch incorporating within a thin flexible substrate, an ECG amplifier, an analog to digital converter, a processor, at least one electrode for contacting the skin of said pregnant woman in her abdomen area, a power source, and a heartbeat indicator;
amplifying a fetal ECG signal from said at least one electrode;
converting an amplified fetal ECG signal to fetal ECG data with said analog to digital converter, said fetal ECG data being contaminated with maternal ECG data;
extracting filtered fetal ECG data from said amplified fetal ECG signal by canceling maternal ECG data from contaminated fetal ECG data;
computing and obtaining at least one fetal vital sign from said filtered fetal ECG data; and
activating said heartbeat indicator with each incidence of a fetal QRS complex detected by said processor. - View Dependent Claims (49, 50, 51)
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Specification