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WO2019211818A1 - Analyse de processus intrapartum et diagnostic d'urgence par un dispositif biomédical non invasif permettant une interférence - Google Patents

Analyse de processus intrapartum et diagnostic d'urgence par un dispositif biomédical non invasif permettant une interférence Download PDF

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Publication number
WO2019211818A1
WO2019211818A1 PCT/IB2019/053659 IB2019053659W WO2019211818A1 WO 2019211818 A1 WO2019211818 A1 WO 2019211818A1 IB 2019053659 W IB2019053659 W IB 2019053659W WO 2019211818 A1 WO2019211818 A1 WO 2019211818A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
surveillance device
intrapartum
labour
probes
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2019/053659
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English (en)
Inventor
Gayathri Mandada
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
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Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2019211818A1 publication Critical patent/WO2019211818A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
    • A61B5/4356—Assessing uterine contractions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/344—Foetal cardiography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
    • A61B5/4362—Assessing foetal parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0866—Clinical applications involving foetal diagnosis; pre-natal or peri-natal diagnosis of the baby
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/488—Diagnostic techniques involving Doppler signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5215—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data
    • A61B8/5223—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for extracting a diagnostic or physiological parameter from medical diagnostic data
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2505/00—Evaluating, monitoring or diagnosing in the context of a particular type of medical care
    • A61B2505/01—Emergency care

Definitions

  • the present disclosure generally relates to the field of biomedical devices. More particularly, the present disclosure relates to monitoring delivery (intrapartum) process which includes the maternal efforts (uterine contractions), fetal descent (fetal position) corresponding cervical dilatation, and maternal and fetal parameters monitoring during intrapartum in a non-invasive manner.
  • the infections again may be indirect from mother either chronic or recent infection, and direct to the foetus by invasive repeated p/v examinations by doctors, by staff nurses by ANMs in government hospitals, in medical collage hospitals, and even by medical students during the intrapartum analysis.
  • An accurate assessment of foetus and its response to various processes of labour by a non-invasive biomedical device would result in prevention of perinatal morbidity and also reduce the morbidity of the patient by eliminating repeated p/v examinations as it causes tissue damage and infection.
  • the existing methods have been invasive, thus causing injury to the soft and vulnerable parts of the patient’s body.
  • Exemplary embodiments of the present disclosure are directed towards a device and method of assessment of intrapartum process and fetal and mother’s parameters.
  • An exemplary object of the present disclosure is directed towards non-invasive method during intrapartum assessment.
  • Another exemplary object of the present disclosure is directed towards monitoring the patient and fetal condition during intrapartum without touching the patient.
  • Another exemplary object of the present disclosure is directed towards reduced repetitive pelvic examination of the patient.
  • Another exemplary object of the present disclosure is directed towards reduced morbidity and mortality rate in the patient and in foetus.
  • Another exemplary object of the present disclosure is directed towards reduced malpractice by recording every step taken during intrapartum analysis.
  • Another exemplary object of the present disclosure is directed towards accuracy in calculation of uterine contractions, dilation of cervix, and descent of foetus in a given time.
  • Another exemplary object of the present disclosure is directed towards operating the device at low radiations like ultrasound.
  • Another exemplary object of the present disclosure is to do single pelvic e amination and to have pelvic measurements to know pelvic diameters, position, presentation, and lie of the foetus, and to assess whether the conditions are favorable for normal delivery and the probable mother can be subjected to the device if else the delivery will by LSCS.
  • Another exemplary object of the present disclosure is directed towards customizable time interval for obtaining the analysed data.
  • Another exemplary object of the present disclosure is directed towards giving respect to a woman with 9 months pregnancy in labour from removing her pain anxiety tension and shame feeling by invasive techniques.
  • Yet another exemplary object of the present disclosure is directed towards minimizing risk for the foetus by avoiding repeated p/v examinations
  • An exemplary aspect of the present subject matter is directed towards the device to monitor foetus and patient, upon the onset of labour.
  • Another exemplary aspect of the present subject matter is directed towards a bunch of probes to send the ultrasound waves into the body of the patient to receive the echoes generated by the waves when placed on the abdominal region; and the cervical region of the patient for imaging.
  • An exemplary aspect of the present subject matter is directed towards suspecting the delay if the contractions are not strong and not in the required number and the foetus not descending and the dilatation of the cervix is slow or not at all dilating according to the time depending norms recognized by the noninvasive biomedical device without touching the patient.
  • An exemplary aspect of the present subject matter is directed towards quick recognition of a problem by non-invasive technique, and quick decision making to interfere with the labour by Lower segment Cesarian section (LSCS) to save the foetus and the mother.
  • Another exemplary aspect of the present subject matter is directed towards a plurality of monitors to display a data analysed by the surveillance device where the monitors are connected to the surveillance device through the bunch of probes for monitoring 4 or 5 people at a time in maternity wards in medical collage Hospitals where the patient’s load is more thus avoiding unnecessary movement of staff and avoiding disturbance to the patient.
  • Another exemplary aspect of the present subject matter is directed towards a user’s personal device connected to the surveillance device through a network and the graphical user interface displays the analysed data and enables interactions between the users.
  • Another exemplary object of the present disclosure is directed towards sitting at one place and supervise the monitor or monitors with full observation.
  • FIG. 1 is a block diagram, depicting the environment for intrapartum process monitoring.
  • FIG. 2 is a flow chart depicting the method for intrapartum process monitoring.
  • FIG. 1 is a block diagram 100, depicting the environment for process monitoring.
  • the figure comprises of a surveillance device 102 which is configured to monitor the fetal activity and the activity of the patient 106 upon onset of labour.
  • the patient 106 may be not limited to, a female about to undergo labour and/or already in labour.
  • the details of the patient 106 may be fed into the surveillance device 102 through a keyboard and/or a touch screen method.
  • the surveillance device 102 may be powered by being electrically operated and/or battery operated thus making it safe for use in remote areas where power cuts are a major concern.
  • the device further comprises of a micro-processor and a memory unit (not shown in the figure) along with a single monitor and/or series of monitors 104 ranging from Ml - Mn.
  • the monitors act as a display unit for the data analysed by the surveillance device 102 which may use electrode patterns to detect the activity of the foetus and the response of the patient 106 when connected to the surveillance device 102 through a bunch of probes 112.
  • the electrical activity generated in the uterine region is recorded along with pelvic measurements.
  • the bunch of probes 112 is configured to send the ultrasound waves into the body of the patient 106 and to receive the echoes generated by the waves when placed on and/or over the abdominal and / or cervical region for imaging as a part of monitoring.
  • the surveillance device 102 is configured to measure non-invasively the fetal and maternal electrocardiography.
  • the surveillance device 102 is further configured to generate data not limiting to, the number of uterine contractions at regular intervals, dilation of cervix, descent time of foetus, fetal heart rate (brachycardia and tachycardia), pulse rate of the patient, oxygen saturation of both the patient and the foetus, and the like.
  • the surveillance device 102 is further connected to a user’s personal device 110 through a network cloud 108.
  • the user here may be the physician in-charge for the patient 106 or any other medical personal attending the patient to have the analysed data to be shared.
  • Another exemplary aspect of measuring the foetal blood flow is the implementation of Colour Doppler Effect through a colour Doppler probe 114 which would detect the presence of umbilical cord around the neck of the foetus.
  • the transverse lie and vertical lie of the baby is detected while performing the pelvic examination of the mother.
  • a high resolution colour Doppler wavelengths are passed through the positioned baby to check the inflow of blood through the umbilical cord. This colour effect detects whether the umbilical cord has been around the neck of the baby. This, confirmed may lead to suffocation thus; the physician accelerates the process of birth through C-section.
  • FIG. 2 is a flow chart diagram 200, depicting the method for intrapartum fetal surveillance.
  • the method starts at step 202 by initiating the intrapartum assessment by connecting a bunch of probes of the surveillance device preferably to the abdomen of the patient undergoing labour. Further, the basic details of the patient are fed into the surveillance device, not limiting to, name, gender, age, details of pre-existing complications, due date, and also programming the analytical parameters of the patient at step 204. Primarily the parameters not limiting to, the fetal heart rate, uterine contraction and cervical dilation of the patient, and the time of descent of the baby are analysed at step 206.
  • Reading the assessments through a visual display on the multiple monitors attached to the probes and colour Doppler probe is done at step 208.
  • the surveillance device for intrapartum analysis is connected to the personal device of the user through a cloud based network at step 210. This enables the physician to obtain a real time status of the condition of the patient without the need of being physically present. This aids the physician to examine multiple patients in a single time and assess an emergency.
  • Monitoring the assessments through the data generated by the surveillance device at regular intervals is done at step 212. The regular intervals may be customized as per the requirement. Determining the uterine contractions accurate for pushing the foetus as a baby through the cervix of the patient is done at step 212.
  • the assessment at step 212 stands crucial for a safe exit of the foetus through the womb of the patient. Active labour starts when cerivical dilatation is 4 cm for every one hour approximately the cervix dilate by 1 cm along with decent of the baby till it dilate about 9.5 to 10 cm which is normal diameter of the baby head (biperital) enabling the delivery of the baby.
  • the device is configured to generate the data at regular intervals till the foetus is pushed down as a baby from the patient’s cervix.
  • the descent of the baby is calculated as per the distance of the descent in a given time, along with this the dilation of the cervix per given time is also calculated.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Cardiology (AREA)
  • Data Mining & Analysis (AREA)
  • Databases & Information Systems (AREA)
  • Physiology (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Pediatric Medicine (AREA)
  • Epidemiology (AREA)
  • Primary Health Care (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

Les modes de réalisation de la présente invention concernent un dispositif de surveillance de processus intrapartum à l'aide d'un dispositif de surveillance pour surveiller une activité foetale et une activité de patiente, l'activité étant surveillée lors du déclenchement du travail ; un groupe de sondes sert à envoyer des ondes ultrasonores dans le corps de la patiente en vue de recevoir les échos générés par les ondes lorsque ledit groupe de sondes est placé sur une région abdominale et une région cervicale de la patiente à des fins d'imagerie ; une pluralité de moniteurs affichent des données analysées par le dispositif de surveillance, les moniteurs étant connectés au dispositif de surveillance par l'intermédiaire du groupe de sondes. Un dispositif personnel d'utilisateur, connecté au dispositif de surveillance par l'intermédiaire d'un réseau et par lequel l'interface utilisateur graphique affiche les données analysées, et permet des interactions entre les utilisateurs.
PCT/IB2019/053659 2018-05-04 2019-05-04 Analyse de processus intrapartum et diagnostic d'urgence par un dispositif biomédical non invasif permettant une interférence Ceased WO2019211818A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201841016911 2018-05-04
IN201841016911 2018-05-04

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Publication Number Publication Date
WO2019211818A1 true WO2019211818A1 (fr) 2019-11-07

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PCT/IB2019/053659 Ceased WO2019211818A1 (fr) 2018-05-04 2019-05-04 Analyse de processus intrapartum et diagnostic d'urgence par un dispositif biomédical non invasif permettant une interférence

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120238894A1 (en) * 2006-12-11 2012-09-20 Principe Jose C System and Method for Analyzing Progress of Labor and Preterm Labor
US9078582B2 (en) * 2009-04-22 2015-07-14 Lifewave Biomedical, Inc. Fetal monitoring device and methods

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120238894A1 (en) * 2006-12-11 2012-09-20 Principe Jose C System and Method for Analyzing Progress of Labor and Preterm Labor
US9078582B2 (en) * 2009-04-22 2015-07-14 Lifewave Biomedical, Inc. Fetal monitoring device and methods

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