ES2335075B1 - MATERNAL-FETAL MONITORING SYSTEM FOR REMOTE DIAGNOSIS. - Google Patents

Abstract

Monitoring system Maternal-fetal for remote diagnosis.

The present invention relates to a system of maternal-fetal monitoring for remote diagnosis which has a local subsystem (6) that facilitates clean signals of the electrocardiograms of the fetus and the mother and that connects to through a communications network (7) with a center of monitoring (8) that can receive a plurality of signals from various local subsystems (6) making them available through of a data network (9), of medical centers or terminals (10) corresponding. Each local subsystem (6) has a pickup device (1) composed of sensors (2) connected to a monitoring chip (3) and housed in a textile support or belt applicable to the pregnant woman, and with a portable patient terminal (5) connected to the chip (3) and the communication network (7).

Description

Monitoring system Maternal-fetal for remote diagnosis.

Object of the invention

The present invention, as expressed in the statement of this specification refers to a system maternal-fetal monitoring for diagnosis remote whose essential purpose is to monitor remotely and non-invasively the heartbeat of an unborn fetus. He electrocardiogram (ECG) is a very important tool in the diagnosis of diseases and cardiac abnormalities, both in children As in adults. In particular, obtaining fetal ECG and cardiac rates of the fetus and mother (FHR, MHR), can reach determine the conditions of the fetus's heart and, in some cases, to diagnose early heart defects such as arrhythmias, ischemia or cardiac abnormalities. In this way, it detect factors that could lead to premature death of the fetus, being able to avoid it sometimes by means of simple Medical treatments applied to the mother. Thus, another object of the invention is that the pregnant woman can remain in her address or continue your daily activity during monitoring, avoiding unnecessary transfers to the hospital, which is very useful in risk gestations

The invention is a pioneer in the area of engineering applied to health, involving a job multidisciplinary in the information sciences, electronics and medicine; being oriented to cover a clear need for the woman during the gestation stage, with the possibility of increase control over the state of the fetus in the later stages of pregnancy, using the new technologies of information and communications, in a comfortable, non-invasive and viable way from the patient's home.

Background of the invention

They are known in the state of the art the following patents related to the invention:

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Patent: MATERNAL-FETAL MONITORING SYSTEM

WO Patent No. 2005/117692.

Date publication: December 15, 2005

Inventors: Marossero, Dorothee; Luliano, Tammy, Y.

It presents a maternal-fetal monitoring system for use during all stages of pregnancy. The system of this invention it comprises a set of sensors, an amplification stage and filtering, a computing and a graphical interface. The data clinics can be extracted and provided to the user in real time using the system of the invention, including signals such as: maternal electrocardiogram (MECG), mother's heart rate, Fetal electrocardiogram and fetal heart rate. System maternal-fetal monitoring of the invention includes  smart media, such as a neural network system, to analyze and interpret clinical data for use in clinical diagnosis in delivery, delivery and postpartum.

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Patent: APPARATUS FOR MONITORING FETAL HEART-BEAT

No. of Publication: WO / 2003/028550.

Date Publication: April 10, 2003.

Inventors: Smith, Mark, John; Penney, Richard, William.

The device serves to monitor the beat of a fetal heart and is able to extract one or more fetal electrocardiograms from a set of signals detected in the abdomen of a pregnant woman. He device includes specific low noise components: a set of low noise electrodes for placement in the abdomen during pregnancy and also a set of processing means Low noise The data obtained is digitized and processed in order to generate a plurality of signal sources, at least one of which represents the fetal electrocardiogram.

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Patent: MINOTOR FETAL DISPOSAL PATCH

No. of publication WO / 2005 / 122883A2

Date Publication: June 2, 2005.

Inventor: Shennib, Adnan.

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This invention provides a disposable patch. Low-cost non-invasive, which continuously monitors the fetal electrocardiogram (FECG). This patch detects the FECG by a maternal electrocardiogram filtering (MECG) .An electrode placed in the upper areas of the pregnant woman is used to obtain a relatively pure signal from the MECG for its cancellation of the signal obtained in the abdomen. On the other hand, multiple are used electrodes placed in the abdominal area and characteristics Periodic dominant MECGs are identified and eliminated. He patch for fetal monitoring is thin, flexible and incorporates a Battery and an alarm. The alarm is activated in case of conditions adverse for the fetus. On the other hand, the patch is programmable and It records the FECG that can be transmitted to a remote receiver.

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Some other patents related to invention are as follows:

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BLIND ADAPTIVE FILER EXTRACTION OF FETAL ELECTROCARDIOGRAM SIGNAL ESTIMATE, WO 2006/081447 A2, August 3, 2006, inventors: Graupe, Daniel and Zhong, Yunde.

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SEPARATING MIXED SIGNALS, US 2007/0027396 Al, February 1, 2007, Inventors: Khaled Assaleh and Hasan Al-Nashash.

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ELECTROCARDIOGRAM SIGNAL PROCESSING METHOD AND ELECTROCARDIOGRAM SIGNAL PROCESSING DEVICE, JP2006204759, August 10, 2006, inventors: Kimura Yoshitaka, Nakao Mitsuyuki; Shinichi path; Okamura Kunihiro; Sato Michiyishi; Ito Takuya; Shimazaki Takayuki; Sugawara Junichi; Senoo Masato

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As for any of the items found which relate to the invention it is possible to mention:

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DESING OF LOW-COST FPGA HARDWARE FOR REAL-TIME ICA-BASED BLIND SOURCE SEPARATION ALGORITHM, authors: Charayaphan Charoensak and Farook Sattar Eurasip Journal on Applied Signal Processing 2005: 18, 3076-3086.

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WIRELESS SYSTEM FOR BIOMEDICAL SENSORS INTERCONNECTION BASED ON BLUETOOTH SYSTEMS, Authors: Luis Alberto Rodríguez García, José Alberto Rabadán Borges, Miguel Ángel Bacallado Marrero, Rafael Pérez Jiménez. Department of Signals and Communications of the University of Las Palms of Gran Canaria.

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WIRELESS BIOMETRIC SYSTEM: ZIGBEE VS BLUETOOTH, authors: Miguel Domínguez durán, Francisco García Sigler, Juan de la Torre Peláez, Francisco Coslado Aristizábal, Amalia Cristina Urdiales García, Sergio Pérez Parras, Rosario Trapero Miralles, Francisco Sandoval Hernández. University of Malaga, Andalusian Center for Innovation and ICT Foundation (CITIC), Communications Technology Center (CETECOM). USSR 2006 - Oviedo, 12-15 September 2006.

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IMPLEMENTATION OF A REGISTRATION SYSTEM AND ECG MANAGEMENT FOR A TELECARDIOLOGY SERVICE, J.D. Wheat, J.M. San Martín, A. Alesanco, P. Serrano, J. García. Group of Communications Technology (GTC), Research Institute de Ingeniería de Aragón (13A), University of Zaragoza, Hospital Lozano Blesa University Clinic.

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We do not know in the current state of the art no maternal-fetal monitoring system with the characteristics of the present invention.

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Description of the invention

To achieve the objectives indicated with previously, the invention consists of a monitoring system maternal-fetal, for remote diagnosis, which Applies to the acquisition and transmission in real time of electrocardiograms and / or heart rates maternal-fetal.

Novelly, according to the invention, the system of it has a local subsystem that facilitates fees cardiac and / or clean signals of the electrocardiograms of the fetus and of the mother with freedom of movement for her and that connects through a communications network with a monitoring center which can receive a plurality of signals from various equipment local making them available, through a data network, of  corresponding medical centers or terminals; where each Local subsystem has:

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a pickup device and a monitoring chip to which connect them. These elements are housed in a support that It consists of biometric sensors connected to a chip monitoring and that is housed in a textile support applicable to the pregnant or patient, and

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a portable patient terminal that connects via communication short-range wireless with the monitoring chip and, through the aforementioned communications network, with the aforementioned center of monitoring

According to the preferred embodiment of the invention, the aforementioned biometric sensors consist of sensor electrodes low noise arranged on a support designed for this purpose and whose number is minimized, so it is the indispensable to capture electrocardiograms of sufficient quality.

In that preferred embodiment of the invention, The monitoring chip includes specific adaptation means and separation that allow to differentiate electrocardiograms from fetus and mother, means of processing and analysis that allow the obtaining cardiac rates and detecting abnormalities in said electrocardiograms, compression means using algorithms specific ones that allow a high quality of reconstruction of the signals corresponding to those electrocardiograms and means of Wireless communication with the patient terminal.

In addition, in the preferred embodiment of the invention the portable patient terminal allows a local monitoring in addition to the remote, including an interface of user that presents a screen or display, some controls and some luminous, acoustic or both indicators, including a warning signal that the sensors are missing correctly located on the patient; presenting also said patient terminal means of connection to the network communications, media with the chip monitoring, a memory card for data storage and USB connectivity.

According to the preferred embodiment of the invention the aforementioned communication between the patient terminal and the chip monitoring is preferably infrared technology, of ultrasound or radio. In addition, according to the embodiment Preferred of the invention, the aforementioned data network may consist in the Internet network and the referred communications network can consist of a mobile telephone network.

The system of the invention must have security and privacy means for protection of medical data and  confidential through the application of protocols processing in the transmission of the corresponding signs.

With the structure described, the system of the invention has a number of advantages, among which highlight the specificity of its design to monitor information fetal, with its differential characteristics compared to others biomedical signals and that has a remote operation not invasive, in real time, allowing control and diagnosis immediate doctor, while the mother can remain at rest in your home or with your daily activity, with total mobility, also presenting great comfort and ease of use, since the pregnant herself can handle the system in regards to local subsystem, given the simple placement of corresponding sensors. In addition, the invention allows to minimize hospitalization times, avoid unnecessary displacement, avoid excessive waiting lists, get early diagnoses and get a more thorough medical control, redundant all in lower associated health costs. The system of the invention is advantageous both in pregnancies at risk and in Pregnancy without risk.

Then, to facilitate a better understanding of this descriptive report and being an integral part of the same, some figures are accompanied in which with character illustrative and not limiting the object of the invention.

Brief description of the figures

Figure 1.- Schematically represents a functional block diagram of a monitoring system maternal-fetal for remote diagnosis performed according to the present invention.

Figure 2.- Schematically represents the physical aspect of a local subsystem that is included in the diagram  of blocks of the previous figure 1.

Figure 3.- Represents a partial view and in perspective of a pregnant woman using a device existing uptake in the local subsystem of the previous figure 2.

Description of an embodiment of the invention

Following is a description of a example of the invention with reference to numbering Adopted in the figures.

The monitoring system maternal-fetal for remote diagnosis of the present example applies to the acquisition and transmission in real time of heart rates and / or electrocardiograms maternal-fetal and has a local subsystem 6 that facilitates this data, with freedom of movement for the mother and that connects through a communications network 7 with a center of monitoring 8 that can receive a plurality of signals from various local subsystems 6 making them available, through of a data network 9, of medical centers or terminals 10 corresponding, as illustrated in figure 1.

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In addition, as can be seen in that figure 1, each local subsystem 6 has a pickup device 1 that It consists of 2 biometric sensors connected to a chip monitoring 3, housing those sensors and chip on a stand applicable to the pregnant or patient 11; also counting the local subsystem 6 with a portable patient terminal 5 that connect via a short range wireless communication 4 with the monitoring chip 3 and through the aforementioned network of communications 7 with the aforementioned monitoring center 8.

Figure 2 shows the constitution of the referred to local subsystem 6, while in figure 3 you can see  the arrangement of the capture device 1 composed of the Biometric sensors 2 and by the monitoring chip 3.

The system of the present example allows the remote monitoring of maternal (MHR) and fetal heart rates (FHR) and / or the fetal electrocardiogram (FECG) non-invasively, through local subsystem 6, capable of acquiring, processing and transmit the FECG signals in real time. The sensors 2 are Low noise sensor electrodes that capture the chest signal and / or abdomen of a pregnant woman or patient 11 and deliver the information captured to the monitoring chip 3, which is a small device in which it is processed and conveniently adapted the corresponding signal, separating the electrocardiograms from the mother and fetus, so that each of the signals corresponding to its two electrocardiograms is processed and analyzed to obtain cardiac rates and detection Immediate anomalies, also compressing with specific algorithms to make the system more efficient maintaining a high quality of reconstruction. Chip monitoring 3, together with the biometric sensors 2 make up the pickup device 1.

The monitoring process can be carried out in locally or remotely since chip 3 incorporates capabilities of wireless communication with the portable patient terminal 5 for sending clinical data to the assigned terminal or medical center 10 through latest generation mobile technologies. This allows its home use in a simple and comfortable way. The communication between the pickup device 1 and the patient terminal 5 is Wireless and short range, presenting low consumption, while long-distance system links are based on state-of-the-art advanced mobile technologies.

Patient terminal 5 is small in size, Lightweight, portable and incorporates a simple user interface constituted by a display, some controls and some indicators luminous and / or acoustic, which facilitates home use of simple and comfortable way without limiting mobility at any time and patient autonomy 11 during monitoring.

The acquisition of the signals of interest is made through a network of low noise sensors 2 placed in the mother's abdomen and chest, as shown in figure 3. The collection device 1 is integrated into a textile support that the pregnant can be easily placed. This way you guarantee that the position of the electrodes or sensors 2 is correct without involve any difficulty for the patient 11. To ensure that the  uptake is carried out correctly it is planned that a processing and control unit in the local subsystem 6 measure the quality of the collected signal, and in the event that it is not adequate notice is given through the patient terminal 5. With it patient 11 knows when the electrodes are not in the correct position and relocation is necessary. Total number of sensors 2 used is the minimum possible to get a good  signal quality, as this provides greater comfort to the patient.

The fundamental part of the system is the chip monitoring 3, which is a device that receives the signals of the various electrodes 2 connected to the mother, and process them to obtain the desired medical interest signals. These signals obtained by the sensors 2 are processed with low noise processing media that have enough sensitivity to detect signals of magnitude of fetal electrocardiogram The corresponding processor circuit is responsible for amplifying the signal through bass amplifiers noise and high resolution, since the fetal signal range is approximately between 10 microvolts and 20 microvolts. He referred circuit is also responsible for filtering the signal to eliminate all unwanted noises and present a signal Amplified and clean for further digital processing. In This stage extracts medical information of diagnostic interest: heart rates and / or fetal and maternal electrocardiograms, through the use of advanced processing techniques. Also I know employs a specific compression procedure to encourage system communications efficiency, without this negatively affects the quality of the signals involved

On the other hand, the comfort of the patient, using wireless technology to communicate the chip monitoring 3 with patient terminal 5, with preference short range technologies and low consumption and dimensions, suitable For medical applications.

To get to the medical center or terminal 10 the corresponding information that the terminal has collected patient 5 this could be a conventional mobile device with wireless link to send data to a center 8 monitoring that will process, store and distribute conveniently

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The system in this example provides four operating modes described below:

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Mode in network: The information obtained is transmitted from the computer uptake 1 to patient terminal 5 that will function as central monitoring device. This communication will have place using a short range 4 wireless link based on the new technologies of low consumption, cost and size. The information collected is sent in real time to the center of monitoring 8 and to an assigned medical terminal 10 within the medical-client service, through technologies advanced mobiles capable of supporting time communication actual between patient terminal 5 and medical terminal 10. Since long range use communications are used public, appropriate security and privacy measures are applied that guarantee the protection of confidential medical data. In this mode of operation is achieved that the reaction time in case of anomaly it is very short, facilitating the taking of doctor's decisions and interaction with the patient in case of be necessary.

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Mode Direct: Thanks to a USB connectivity presented by the terminal patient 5, the system can be used in medical centers during a routine consultation To do this, during the collection it is directly download the signal logs correctly processed on a computer for viewing using a specific display software.

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Mode Holter: Thanks to the use of an auxiliary memory card in the patient terminal 5 electrocardiograms can be stored captured, which will then be supplied to the doctor. This Work mode resembles the usual Holter for ECG. Is Recommended for studies that require continuous monitoring for a prolonged period of time. The possibility is offered of, in addition to storing the corresponding data, every certain time send a signal segment to the doctor using the procedure defined as network mode for more control detailed.

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Mode stand-alone: The monitoring device through the terminal patient 5 can work independently, capturing and processing the FECG and MECG signals to supply the patient simple information through a series of light indicators and acoustics and a display, to indicate fetal heart rates and maternal (FHR, MHR).

Regarding the monitoring center 8 fits indicate that you receive all the information from the patients monitored, for advanced processing, classification, storage and distribution to medical centers. This center 8 links to a mobile communications network to connect with the local computer 6, and uses the Internet as a data network 9 to transmit the information collected to specialists corresponding that are in each medical terminal 10.

From the monitoring center 8, they are managed all additional services of alerts, notices, etc. Thank you to the link with networks 7 and 9, giving great versatility to system. The monitoring center 8 will include a module of access control and security given the highly Confidential of the information handled, being important the use of encryption and authentication techniques to ensure data privacy and integrity; fulfilling like this scrupulously the associated recommendations and regulations of the LOPD

Moreover, the monitoring center 8 can facilitate a virtual monitoring center with the object to facilitate access, analysis and understanding of information received from local subsystems 6 monitored by the medical-client services, being given to authorized specialists restricted access via web to said center virtual monitoring, which consists of a medical portal specialized, designed to provide adequate visualization of Signal records Thus, the clinical data of interest will be available to the doctor ubiquitously, which results in great utility in case of emergency, and always safely to Safeguard the privacy of the data. The virtual center of monitoring not only offers the possibility of displaying fetal signals, but makes available to the doctor additional tools for monitoring each patient, through a specific database capable of hosting all the clinical information of interest and the medical history of each of they. Likewise, forums are offered for interprofessional consultation, possibility of sharing information with other colleagues, publication of events or news of gynecological interest, and others features that facilitate data networks such as Internet.

Claims (7)

1. Maternal-fetal monitoring system for remote diagnosis, which is applied to the real-time acquisition and transmission of maternal-fetal heart rates, maternal-fetal electrocardiograms (ECG), or a combination of both; characterized in that it has a local system (6) that facilitates cardiac rates, clean signals of the electrocardiograms of the fetus and of the mother, or a combination of both, with freedom of movement for the mother and that connects through a communications network (7) with a monitoring center (8) that can receive a plurality of signals from various local subsystems (6) by making them available to corresponding medical centers or terminals (10) through a data network (9); where each local subsystem (6) has:

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a pickup device (1) consisting of sensors biometric (2) connected to a monitoring chip (3) and which lodges in a textile support applicable to the pregnant or patient (11 and

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a portable patient terminal (5) that connects by means of a short range wireless communication (4) with the chip monitoring (3) and through the aforementioned communications network (7) with the aforementioned monitoring center (8).

2. Maternal-fetal monitoring system for remote diagnosis, according to claim 1, characterized in that said biometric sensors (2) consist of low noise sensor electrodes arranged in a specific support. 3. Maternal-fetal monitoring system for remote diagnosis, according to claim 1, characterized in that said monitoring chip (3) includes specific means of adaptation and separation that allow differentiating the fetal and mother electrocardiograms, processing and analysis means that allow calculate cardiac rates and detect abnormalities in said electrocardiograms, compression means by means of specific algorithms that allow a high quality of reconstruction of the signals corresponding to those electrocardiograms and means of wireless communication with the patient terminal (5). 4. Maternal-fetal monitoring system for remote diagnosis, according to claim 1, characterized in that said portable patient terminal (5) allows local monitoring in addition to the remote, including a user interface that has a screen or display, controls and some luminous, acoustic indicators or a combination of both, including a warning signal that the sensors (2) are not correctly located on the patient (11); further presenting said patient terminal (5) means of connection with the communication network (7), means of communication with the monitoring chip (3), a memory card for data storage, and USB connectivity. 5. Maternal-fetal monitoring system for remote diagnosis, according to claim 1, characterized in that the communication between the monitoring chip (3) and the patient terminal (5) is carried out by wireless infrared, ultrasonic, radioelectric or radio technology. other. 6. Maternal-fetal monitoring system for remote diagnosis, according to claim 1, characterized in that said data network (9) consists of the Internet network, and the communications network (7) consists of a mobile telephone network. 7. Maternal-fetal monitoring system for remote diagnosis, according to claim 1, characterized in that it has security and privacy means for the protection of confidential medical data through the application of processing protocols in the transmission of the corresponding signals.