The present invention relates to basic developmental biology, portable medical obstetric procedures and devices, and more particularly to the non-invasive monitoring of the positions and certain body parts of a developing human fetus inside the mother's womb.
Many of the developmental disorders of childhood—cerebral palsy, epilepsy, cognitive impairment from prematurity and autism—appear to result from an interaction of complex genetic traits and environmental factors. Likewise, adult psychiatric diseases may have their origins in impaired early, even fetal development, as proposed for schizophrenia [1]. Despite major efforts, these prevalent, debilitating, life-long disorders remain biologically unexplained. Based on animal studies, the development of most types of epilepsy, cerebral palsy, autism and schizophrenia is suggested to link to neonatal seizures and various disturbances during the fetal development. The intimate connection between mother, fetus and placenta, the vast array of hormones expressed in the mother or in the placenta, or a variety of other environmental factors (injuries, drug treatments, immune responses, infections, hypoxic stress) make the targets when investigating fetal environmental disruptions that can affect fetal health. In most cases, it is already too late after birth to permanently reverse the poor health outcomes, as they are being developed early due to microenvironmental alterations. Therefore, monitoring fetal activity is crucial to prevent certain diseases.
Detecting electrical signals is generally known in the medical arts. Use of ultrasound to display a fetus or to measure its Doppler cardiogram is also generally known in the medical arts. Recording of fetal brain wave and heart signals is known in the prior art, for example in U.S. Patent No. 20020193670, U.S. Patent No. 20100274145 , U.S. Pat. No. 6,556,861 to Prichep, and in U.S. Pat. No. 7,016,722 to Prichep. The entire disclosures of these patents are expressly referred to and incorporated herein by reference thereto.
Use of a maternity belt is known in the prior art, for example in U.S. Patent Pub. No. 2007/0037483, having a publication date of Feb. 15, 2007. The entire disclosure of this patent is expressly referred to and incorporated herein by reference thereto.
Use of an optical imaging system with 3D tracking facilities is known in the prior art, for example in U.S. Patent Pub. No. 2010/0010340, having a publication date of Jan. 14, 2010. The entire disclosure of this patent is expressly referred to and incorporated herein by reference thereto.
It is a problem in the prior art to detect spontaneous brain activity in a developing fetus. As a consequence, it is also a problem in the prior art to detect signs of epilepsy or other brain injuries or disorders in a developing fetus, as in most cases these are not correlated with responses to auditory stimuli. There is accordingly a need in the prior art for a small, portable device (e.g. a smartphone-based instrument) that provides the convenience to a pregnant woman to perform such long-term measurements at home, anytime; and preferably after being trained in its use by a physician.
It is a further problem and need in the prior art to provide a portable fetal-EEG recording device that is extremely sensitive, detecting potentials of even below 1-2 microvolts, capable of detecting and recording signals over an extended period of time, and perform the steps of analyzing the recorded signals for signs of developmental brain disorders in the developing fetus.
It is also a problem in the prior art to provide visual control of the fetus, in order to determine the movement of the fetus between the time of application of the electrodes to the time of later measurements. This is intended to prevent occurrence of artifacts in the recordings. In accordance with the present invention, the brain waves of the fetus can not only be correlated to its position and activity, but also to its ECG (electrocardiogram) patterns or its Doppler-based heart rate, to better understand how its current brain activity changes during awake and sleep states.
It is a problem in the prior art to determine the position of a fetus accurately without ultrasound scanning, which is a crucial criterion for signal interpretation. Most pregnant women don't feel comfortable using an ultrasound device on themselves; therefore an alternative technique for ultrasound imaging is needed in order to be able to perform fetal electrophysiology at home, without requiring a physician's supervision. There is accordingly a need in the prior art for a non-invasive and safe way of determining and displaying fetal positions, to locate the electrophysiology biosensors to the correct positions to record fetal heart- and brain waves.
The claimed method and portable system provides a new, inexpensive and non-invasive fetal visualization process that helps to locate fetal body parts and identify fetal positions without exposing the fetus to prolonged ultrasound irradiation. Associating location data with biological electrophysiology signal patterns and/or light absorption/ reflection-related tissue-specific local fetal body composition data enables the generation of a 3D anatomical and functional map of the fetal body through the expecting mother's womb, which will be essential for long-term home monitoring of a fetus during pregnancy.
The present invention, discussed in detail hereunder, relates to a portable device and a method for using the portable device to detect fetal heart rate and EEG signals, and to detect signs of normal and abnormal fetal development. The device of the present invention provides an Internet connection, and it serves as an apparatus for performing and analyzing fetal-EEG and ECG recordings in parallel with fetal visualization. Furthermore it is also capable of associating 3D maternal abdominal locations to fetal tissue-specific optical features (light absorption, reflection), and matches fetal body anatomy with functional organ-specific electric activity patterns.
In many countries, practically all pregnant women undergo routine obstetric ultrasound (US) examinations, once or several times during pregnancy. Usually, one of the examinations is done at 16 to 22 gestational weeks for detection of fetal anomalies. At this time of pregnancy, the migration of neurons into the fetal neocortex is not finished [2] and concerns have been expressed that ultrasound might disturb this process [3]. In a Norwegian study [4], a cohort of pregnant women were divided in two groups. Half of the mothers had real ultrasound scanning during pregnancy while the others had a sham investigation. When the children were examined after birth there was significant excess of left-handedness only in the group exposed to real ultrasonography. In addition, recent in vitro and in vivo results demonstrate that US can be used to modulate action potential firing and synaptic transmission [5-11]. Consequently, there has been an emerging need to develop a new fetal visualization technique as an alternative to ultrasound scanning that may be suitable for everyday home use for monitoring high-risk pregnancies.
Technologies which can be used in the present invention, and which are commercially known and available for use, are known in the art and samples of these are as follows. Portable computer software capable of overlaying computer graphics on the real world (e.g. a real-time camera image) are broadly known and referred to as Augmented Reality (AR) in prior arts. Examples would be known to any one skilled in the 3D imaging arts and especially the patents classified in US patent class 345/633 (real-time Augmented Reality), such as Nokia's U.S. Patent Application 20120075341 published on Mar. 29, 2012. The type of electrodes and method of use feasible for the present invention are known, for example in U.S. Pat. No. 6,162,101 issued on Sep. 3, 1998 to Fisher and Iversen; U.S. Pat. No. 6,024,702 issued on Feb. 3, 1997 to Iversen; U.S. Pat. No. 5,961,909 issued on Sep. 3, 1997 to Iverson; U.S. Pat. No. 5,902,236 issued on Sep. 3, 1997 to Iversen; as well as in other patent documents. The possibility of recording spontaneous electrical brain and heart activity of a fetus in utero has also been published [12, 13].
Hand-held optical probes utilizing near-infrared (NIR) 3D imaging for diagnostic purposes have also been known in prior art, for example from U.S. Patent Application 2010/0010340 A1 published on Jan. 14, 2010. In addition, it has been reported that different biological tissue types show differences in their light absorption and reflection properties [14]. Accordingly, for example fetal tissue types that are rich in fat and water (such as the brain) have a maximum absorption peak at the wavelenth of ˜930 nm; whereas umbilical arteries and veins have their highest absorption peaks at ˜410 nm and ˜580 nm. These differences have been utilized for agricultural purposes (quality control of food items) or body composition screening (for example, U.S. Pat. No. 7,711,411 B2; issued on May 4, 2010), and in medical device arts to screen intracranial bleeding in head trauma patients (for example, U.S. Pat. No. 8,060,189), or placental circulation [15]. However, it has never been proposed as an indirect alternative of ultrasound, feasible for fetal monitoring via measuring the body composition of the fetus.
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The element 186 can be a fetal-EEG and/or ECG recording device which records EEG and/or ECG signals from electrodes. The portable device 10A can be similar or identical to the portable device 10 shown and discussed hereinabove, or it can be a variation of that device.
The portable device 10A includes a memory device 102 which can, for example, be a high capacity SD card or other type of memory device. The portable device 10A also includes a controller 104 which can, for example, be a computer or computer chip, a smartphone, smart touchpad device having computer techology, etc.
The portable device 10A also includes an analyzing function means 106 such as local software used by the controller 104, or else supplies data to a remotely based computer for software analysis using the internet or cell phone technology.
The portable device 10A provides outputs, which can include fetal heart rate, noise and artifact filtered EEG, ECG and/or integrated EEG signals 202, 3D optical and fetal body composition map, and an indication of fetal developmental abnormalities such as intrauterine seizures or other abnormal brain- or heart activity, or abnormal durations of sleep and awake states 206. These signals can be obtained using the software represented by block 106.
The detection and determination of normal and abnormal human fetal brain activity is an evolving field. It is anticipated that future discoveries may be made in this evolving field, and it is contemplated that the results of such discoveries can be used in the indication of abnormal fetal development 206.
In step 240, a portable multi-channel electrophysiology recording is connected to the electrodes. Step 260 is using the portable device 10 or 10A to record the brain and/or heart activity of the fetus (using the signals received from the electrode or electrode sheet) for extended time periods. In step 280, the organ-specific electric signals are associated with 3D locations, and the electrode position where the maximum amplitudes of fetal ECG signal appears is matched with a virtual heart position, and the electrode positions where the maximum amplitudes of fetal brain-wave signals appear are correlated to fetal head positions.
In step 300, the fetal image projected in step 210 is adjusted to the 3D signal map determined in step 280. Finally, in step 330 the portable device 10 or 10A records and stores the registered data and images, analyzes the signals and determines the health status, movements and developmental stage of the fetus.
In another embodiment, step 230 is attaching multiple electrodes, light sources and sensors, and/or ultrasound transducers and detectors to the abdomen of the mother. In step 250, a portable multi-channel electrophysiology recording and signal processing device is connected to the electrodes. Step 270 is using the portable ultrasound and/or imaging module with CCD system, detector fibers and multiple-point ultrasound transducers and/or light sources to launch ultrasound signals and/or light rays of specific wavelengths on the abdomen of the mother in a simultaneous or sequential manner. In step 290, the reflected bodypart- or object-distance-specific ultrasound signal, and/or the tissue-specific light intensity, and/or functional electric signals are associated with 3D locations.
In step 310, portable device 10 or 10A generates a 3D fetal body composition and/or functional tissue-specific electric signal map and/or ultrasound image map based on the optical, ultrasound and electric input data. In step 320, the fetal image projected in step 210 is adjusted to the 3D signal map determined in step 320. Finally, in step 330 the portable device 10 or 10A records and stores the registered data and images, analyzes the signals and determines the health status, movements and developmental stage of the fetus according to the previously generated 3D map.
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Optionally, step 330 may include using the portable system to take pictures and/or videos and/or sound files of the baby to send to relatives, friends, and/or medical professionals, and/or to provide a continuous stream of video for webcam or videoconferencing purposes. In another embodiment, the imaging software is further capable of detecting fetal motions, and adjusting the 3D data map automatically, according to the newly recorded electric signal-maximum or body composition data coordinates, or reflected ultrasound signals.
The invention being thus described, it will be evident that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention and all such modifications are intended to be included within the scope of the claims.
This application is a continuation-in-part of U.S. Ser. No. 14/068,951 filed on Oct. 31, 2013, now pending, which in turn is a continuation-in-part of U.S. Ser. No. 13/396,233 in the name of the inventor Marianna Kiraly filed on Feb. 14, 2012, now pending, which in turn claims the priority of Provisional Patent Application Ser. No. 61/627,626, filed on Oct. 14, 2011, in the name of the inventor Marianna Kiraly. These applications are hereby expressly incorporated herein in their entirety by reference thereto.
Number | Date | Country | |
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Parent | 13396233 | Feb 2012 | US |
Child | 14259172 | US | |
Parent | 14068951 | Oct 2013 | US |
Child | 13396233 | US |