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WO2004016163A1 - Systeme et procede de controle foetal - Google Patents

Systeme et procede de controle foetal Download PDF

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Publication number
WO2004016163A1
WO2004016163A1 PCT/IL2003/000667 IL0300667W WO2004016163A1 WO 2004016163 A1 WO2004016163 A1 WO 2004016163A1 IL 0300667 W IL0300667 W IL 0300667W WO 2004016163 A1 WO2004016163 A1 WO 2004016163A1
Authority
WO
WIPO (PCT)
Prior art keywords
fetal
curvature
monitoring system
light
optical fiber
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/IL2003/000667
Other languages
English (en)
Inventor
Anatoly Babchenko
Valeri Chernyak
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.)
MYSENS Ltd
Original Assignee
MYSENS Ltd
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 MYSENS Ltd filed Critical MYSENS Ltd
Priority to AU2003249566A priority Critical patent/AU2003249566A1/en
Publication of WO2004016163A1 publication Critical patent/WO2004016163A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A61B5/02411—Measuring pulse rate or heart rate of foetuses
    • 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
    • A61B5/43—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
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0261—Strain gauges
    • A61B2562/0266—Optical strain gauges

Definitions

  • the present invention relates to a system and a method for monitoring fetal heart rate and fetal and maternal movements, for biophysical assessment of fetal well-being and tocodynamometry.
  • Fetal neuro-muscular activity is one of the basic physiological functions of the developing fetus and is necessary for its normal neural, muscular and skeletal development. Fetoplacental unit dysfunction or severe impairment of the supply of nutrients through maternal circulation are expected to, and do, lead to decreased fetal neuro-muscular activity. Accordingly, it has long been recognized that there is a direct correlation between fetal movement and the health of the pregnancy; in other words, reduced fetal movement has value as a predictor of intrauterine fetal death or as an ominous sign of the loss of fetal well-being. This knowledge has led to the clinical use of fetal movement assessment in preventing fetal death and untoward outcome of pregnancy, in both low and high risk pregnancies. Reassuring maternally perceived fetal activity has been defined as an average of four or more fetal movements per hour, when counting was performed for at least one hour per day. Three or less movements per hour, for two consecutive days, have been defined as abnormal.
  • Maternal compliance with any fetal movement-counting protocol is a major problem. Approximately only 80% of the patients adhere to the counting protocol; only 40-60% of those counting report decreased fetal movements when required to do so by the criteria set in their counting protocol. Thus, fetal movement-counting protocols are correctly exercised by only 50% of the participating patients. Given the unreliability of the measuring instrument, i.e., the mother, it is therefore truly remarkable that the great majority of the studies published to date clearly demonstrate the clinical usefulness of fetal movement-counting by the mother in preventing fetal death and exposure to danger. Maternally perceived fetal movement-counting is undoubtedly beneficial. The difficulties encountered in implementing the different fetal movement-counting protocols render extremely important the development of a device that will facilitate the recording of maternally perceived fetal movement and standardize the interpretation of the movement record.
  • a further parameter indicative of fetal well-being is the fetal heart rate, the determination of which assists the physician in deciding whether the condition of the fetus requires immediate medical attention.
  • fetal heart rate the determination of which assists the physician in deciding whether the condition of the fetus requires immediate medical attention.
  • Stethoscopes have been used to listen to the fetal heart rate; however, their use has been unsatisfactory, due to the high degree of extraneous or artifact noise or the maternal heart beat. In addition, such devices are impractical for in-home patient use.
  • Fetal heart beats are routinely detected indirectly from the interior abdominal wall, or directly by one of several methods. Such indirect methods of detection involve the use of electrodes, which pick up the weak fetal electrocardiogram on the maternal abdomen, or the employment of an ultrasonic Doppler transducer, which detects Doppler frequency shifts in ultrasonic energy reflected from moving components of the fetal cardiovascular system.
  • Ultrasonic Doppler systems for monitoring fetal heart rate have been generally inconvenient to use, because the fetal heart beat is difficult to locate and, once found, the device has to be frequently relocated.
  • Most of the ultrasonic Doppler systems available today include an ultrasound probe together with processing circuitry attached by wires to a loudspeaker.
  • Other known systems which utilize Doppler probes are hard-wired to speakers which, for example, can be clipped to the physician's shirt pocket. Such systems, however, are not intended to be used by a patient for self-testing purposes, let alone to be used at home in conjunction with means enabling subsequent analysis by a physician.
  • U.S. Patent No. 5,257,627 teaches a fetal monitoring apparatus comprising an ultrasonic transducer that generates ultrasonic vibrations which are directed at the fetal heart or other organs.
  • the reflected ultrasonic waves are sensed by an appropriate sensor and are analyzed using the well-known Doppler principle.
  • Such equipment is relatively large and bulky, and cannot monitor fetal well-being while the mother goes about her daily life.
  • Ultrasonic techniques also have the serious disadvantages of being of an invasive nature, applying a stream of high-frequency ultrasonic energy to the developing fetus and the fetal heart valves. Such invasive action may have significant detrimental effects on the fetus, as well as requiring a tedious alignment of the transducer with the fetal heart; even moderate movement of the patient will often result in erroneous readings.
  • U.S. Patent No. 5,140,992 teaches a passive fetal monitoring system, using a piezoelectric polymer material detector that is applied to the abdomen of the pregnant woman and produces an electrical signal as a result of fetal activity.
  • the sensors used in this system are relatively large and of a limited sensitivity, making it difficult to detect very small potential differences, such as those generated by weak fetal activity.
  • this method cannot be used with signals having an AC component, such as the signal produced by a heart beat. Disclosure of the Invention
  • a system for monitoring fetal heart rate and fetal and maternal movements comprising a flexible, but non-stretchable, belt portion, to be worn around the abdomen of a pregnant woman; at least one unit comprising a length of optical fiber leading from a light source to a light detector, said optical fiber is bent at least once on its way from the light source to the light detector, thereby producing at least one curvature; a mechanical linkage coupled between said belt portion and said bent fiber for converting a change in the circumference of the abdomen occasioned by the onset of fetal heart beat and/or fetal and/or maternal movement, to a corresponding change of said curvature; whereby light transmittance of said optical fiber is changed and detected by said detector.
  • the invention further provides a method monitoring fetal heart rate and fetal and maternal movements, comprising providing at least one system including a flexible, but non-stretchable, belt portion, to be worn around the abdomen of a pregnant woman, at least one unit comprising a length of optical fiber leading from a light source to a light detector, said optical fiber is bent at least once on its way from the light source to the light detector, thereby producing at least one curvature; affixing said belt portion to the abdomen of a pregnant woman for detecting changes in the circumference of the abdomen occasioned by the onset of a fetal heart beat and/or a fetal or maternal movement; detecting changes in light transmittance resulting from changes of fiber curvature, and processing and interpreting the signals received from said light detector.
  • Fig. 1 represents a pregnant woman wearing the monitoring system of the present invention
  • Fig. 2 illustrates a first embodiment of a monitoring system according to the present invention
  • Fig. 3 illustrates a modification of the embodiment of Fig. 2
  • Fig. 4 illustrates the monitoring system with the optical fiber loop in its initial state
  • Fig. 5 illustrates the monitoring system with the optical fiber loop compressed
  • Fig. 6 represents a cascade arrangement of the monitoring system.
  • Fig. 1 a pregnant woman wearing around her abdomen the monitoring system according to a preferred embodiment of the present invention.
  • the system is seen to comprise a belt portion or a belt 2 (hereinafter referred to as a "belt") made of a flexible but non-stretchable material, one end of which is threaded through a buckle 4 and pulled back and attached to the other end of the belt, advantageously by means of Velcro® fasteners.
  • Fig. 1 is a loop 6 formed by a bent optical fiber 7 accommodated in housing 8.
  • the ends 10, 10' of fiber 7 lead into another housing 12, containing a light source 11 (Figs. 2 and 4) which provides light for end 10 of loop 6, and a light detector 13 at end 10'.
  • a processing unit 14 Housings 8, 12 and processor 14 are fixedly attached to belt 2.
  • the working principle of this continuous monitoring system according to the present invention is based on the fact that light propagating in a light guide is attenuated when this light guide is bent, with attenuation increasing with increasing curvature, i.e., with a decreasing radius of the bend.
  • the preferred embodiment utilizes one or several fiber loops for two reasons: the overlapping of several loops of a fiber provides a controlled, more accurate movement of the fiber and amplifies the effect of the attenuation of light at the bent portions of the fibers, resulting from the pulling of the belt, and the plurality of loops renders it to be springy, positively effecting its return to an initial position.
  • the attenuation coefficient ⁇ for a step index fiber is given by the expression
  • n ⁇ refractive index of fiber core
  • Fig. 2 there is illustrated a further embodiment of the invention. Seen are the ends 2', 2" of the belt 2, pull elements 16, 16', e.g., a pull rod, pull wire of the like, each attached to one end of a U-shaped bent fiber 7, forming a curvature 9, receiving light from the light source 11 and transmitting light at its other end 10' to the light detector 13.
  • pull elements 16, 16' e.g., a pull rod, pull wire of the like
  • FIG. 3 A modification of the embodiment of Fig. 2 is shown in Fig. 3.
  • the fiber instead of a fiber 7 having a single curvature, the fiber is bent over to form at least one loop 6 having several curvatures 9, 9'.
  • semi-rigid or rigid surfaces 17, 17' e.g., rods, bars, slats or the like, affixed to the linear portions of loop or loops 6, so as to avoid the bending of these portions, but only of the curved portions. This will result in a more accurate and sensitive monitoring system.
  • optical fiber 7 forms an elongated loop 6, which may have one or more turns.
  • the slightest movement of the fetus, and even the miniscule pressure wave generated by the fetal heart beat, are transferred to belt 2 and are transmitted by the latter to a mechanical linkage comprised of buckle 4, to which are operatively attached non-stretchable pull element 16, a lever 18 and a rigid pressure surface 20, which is in constant contact with the non-curved portions of the loop 6.
  • Lever 18, to which pull element 16 is articulated at point 22, has a fulcrum 24.
  • Pressure surface 20 is articulated to the free end of lever 18.
  • this impulse transferred by the mother's abdominal wall to non-stretchable belt 2, causes the pull element 16 attached to the buckle 4 to move from its position of rest by a distance a (Fig. 4).
  • the change in curvature produces an attenuation of the light flux originating in light source 11 and passing along optical fiber 7. This attenuation is sensed by light detector 13, which produces a signal that is led to processor 14.
  • the elastic resilience of fiber loop 6 restores its original shape, as well as the original position of the mechanical linkage.
  • the sensitivity of the mechanical arrangement is determined by the relationship
  • Processor 14 includes an amplifier and a comparator.
  • the voltage signals are amplified and compared with an array of previously determined signals characteristic of potential fetal and maternal activities.
  • the processor may also include a digital recording system and computer memory, permitting the signals detected by detector 13 to be stored for later replay and analysis by a supervising clinician. Further envisioned are a real-time display screen, with signals supplied by processor 14, as well as an alarm block for real-time warning about dangerous changes in fetal (or maternal) conditions.
  • Processor 14 may also provide the possibility to communicate with remote locations, using different linking means such as e-mail, mobile phone, telephone, and others.
  • Processor 14 also includes a battery compartment.
  • belt 2 is not a one-piece belt, one end of which is threaded through buckle 4, pulled back and attached to the other end of the belt by Velcro® fasteners, but rather, consists of at least two separate, but mechanically interlinked sections, one section carrying housings 8 and 12 and processor 14, and the other section being fixedly attached to buckle 4, which serves as an interlinking member. It is possible that in some cases, the fetal and/or maternal movements such as contractions are so large that compression of loop 6 would cause the critical angle ⁇ c to be exceeded, thus frustrating total internal reflection of the light. For such cases, the invention provides the cascade arrangement shown in Fig. 6, in which several units, such as those illustrated in Figs. 4 and 5, are series-connected.
  • Unit I is provided with stops (not shown) that prevent the compression of loop 6 beyond the point where its critical angle ⁇ c would be exceeded.
  • unit II is activated.
  • the loop 6 of unit II must be formed of a fiber 7 stiffer than that of unit I.
  • unit III comes into action.
  • fiber 7 of unit III must be stiffer, than that of unit II. The signals from each unit have to be measured separately.
  • bent fibers and the loops shown in the drawings are half-turn, full-turn loops or, as mentioned above, multi-turn loops made of single fiber, twisting or braiding the curved portions of the fibers has an enhancing effect on the sensitivity of the arrangement.
  • the belt need not necessarily surround the entire abdomen or waist and that the belt could be constituted by two sections, each connected at one end to the housing 8 and attachable to the body of a pregnant woman by means of stickers or sticking members, for example, at the body's sides or back.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Cardiology (AREA)
  • Reproductive Health (AREA)
  • Physiology (AREA)
  • Pediatric Medicine (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

Système servant à contrôler le rythme cardiaque d'un foetus, ainsi que les mouvements foetaux et maternels, et comprenant une partie ceinture souple mais non extensible, conçue pour être portée autour de l'abdomen de la femme enceinte, un ensemble possédant une longueur de fibre optique s'étendant entre une source de lumière et un détecteur de lumière, cette fibre optique étant incurvée au moins une fois sur son trajet depuis la source de lumière jusqu'au détecteur de lumière, ce qui produit une incurvation, un accouplement mécanique entre la partie ceinture et la fibre incurvée servant à convertir une modification de l'abdomen provoquée par le déclenchement du rythme cardiaque du foetus et/ou d'un mouvement maternel et/ou foetal, en une modification correspondante de l'incurvation, ce qui permet de modifier la transmittance lumineuse de la fibre optique et de la détecter au moyen du détecteur. L'invention concerne également un procédé servant à contrôler le rythme cardiaque du foetus et les mouvements foetaux et maternels.
PCT/IL2003/000667 2002-08-15 2003-08-12 Systeme et procede de controle foetal Ceased WO2004016163A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003249566A AU2003249566A1 (en) 2002-08-15 2003-08-12 System and method for fetal monitoring

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL151284 2002-08-15
IL15128402A IL151284A0 (en) 2002-08-15 2002-08-15 System and method for fetal monitoring

Publications (1)

Publication Number Publication Date
WO2004016163A1 true WO2004016163A1 (fr) 2004-02-26

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IL (1) IL151284A0 (fr)
WO (1) WO2004016163A1 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007108028A1 (fr) * 2006-03-23 2007-09-27 Roberto Angioli Unité intégrée de surveillance de grossesse
WO2011003132A1 (fr) * 2009-07-06 2011-01-13 Heard Systems Pty Ltd Mesure non invasive d’un processus physiologique
GB2505424A (en) * 2012-08-28 2014-03-05 Jessica Leigh Jones Fibre optic uterine contraction monitor
US8761865B2 (en) 2005-03-10 2014-06-24 Anatoly Babchenko Optical sensor and a method of its use
WO2017162686A1 (fr) * 2016-03-21 2017-09-28 Koninklijke Philips N.V. Système et procédé de surveillance des mouvements du fœtus
CN108471986A (zh) * 2016-01-21 2018-08-31 普莱西公司 用于使用身体部位的周长改变进行健康监测的装置、系统和方法
WO2018211403A1 (fr) * 2017-05-15 2018-11-22 Bloom Technologies NV Systèmes et procédés de surveillance du bien-être fœtal
WO2019109119A1 (fr) * 2017-12-06 2019-06-13 Umweltdata G.M.B.H. Dispositif de mesure de la circonférence d'arbres
CN111163689A (zh) * 2017-10-06 2020-05-15 皇家飞利浦有限公司 用于测量子宫收缩和胎儿心率的设备
JP2020138022A (ja) * 2019-02-27 2020-09-03 国立大学法人信州大学 胎児心拍数測定方法並びに胎児および母体の同時監視方法
CN113693577A (zh) * 2021-08-09 2021-11-26 武汉理工大学 基于光纤传感的胎心监护托腹带
CN113974943A (zh) * 2021-09-30 2022-01-28 湖北佑庭科技有限公司 一种基于光纤传感的监听托腹带及其监测方法
US11672477B2 (en) 2017-10-11 2023-06-13 Plethy, Inc. Devices, systems, and methods for adaptive health monitoring using behavioral, psychological, and physiological changes of a body portion

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5134281A (en) * 1990-01-31 1992-07-28 E.L. Bryenton & Associates Inc. Microbend optic sensor with fiber being sewn thereto in a sinuously looped disposition
US5140992A (en) * 1990-07-16 1992-08-25 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Passive fetal monitoring sensor
IL110210A (en) * 1994-07-04 1997-11-20 Jerusalem College Tech Device for sensing movements of a body

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5134281A (en) * 1990-01-31 1992-07-28 E.L. Bryenton & Associates Inc. Microbend optic sensor with fiber being sewn thereto in a sinuously looped disposition
US5140992A (en) * 1990-07-16 1992-08-25 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Passive fetal monitoring sensor
IL110210A (en) * 1994-07-04 1997-11-20 Jerusalem College Tech Device for sensing movements of a body

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 9809, Derwent World Patents Index; AN 1998-089852, XP002263295, "Device for sensing movements of a body - comprises elastically interconnected members, and an optic fibre connected to a source of light" *

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8761865B2 (en) 2005-03-10 2014-06-24 Anatoly Babchenko Optical sensor and a method of its use
WO2007108028A1 (fr) * 2006-03-23 2007-09-27 Roberto Angioli Unité intégrée de surveillance de grossesse
WO2011003132A1 (fr) * 2009-07-06 2011-01-13 Heard Systems Pty Ltd Mesure non invasive d’un processus physiologique
US8652063B2 (en) 2009-07-06 2014-02-18 Heard Systems Pty Ltd Non-invasively measuring physiological process
GB2505424A (en) * 2012-08-28 2014-03-05 Jessica Leigh Jones Fibre optic uterine contraction monitor
CN108471986B (zh) * 2016-01-21 2021-09-07 普莱西公司 用于使用身体部位的周长改变进行健康监测的装置、系统和方法
CN108471986A (zh) * 2016-01-21 2018-08-31 普莱西公司 用于使用身体部位的周长改变进行健康监测的装置、系统和方法
CN109414207A (zh) * 2016-03-21 2019-03-01 皇家飞利浦有限公司 胎动监测系统和方法
WO2017162686A1 (fr) * 2016-03-21 2017-09-28 Koninklijke Philips N.V. Système et procédé de surveillance des mouvements du fœtus
WO2018211403A1 (fr) * 2017-05-15 2018-11-22 Bloom Technologies NV Systèmes et procédés de surveillance du bien-être fœtal
CN111163689A (zh) * 2017-10-06 2020-05-15 皇家飞利浦有限公司 用于测量子宫收缩和胎儿心率的设备
CN111163689B (zh) * 2017-10-06 2022-06-28 皇家飞利浦有限公司 用于测量子宫收缩和胎儿心率的设备
US11672477B2 (en) 2017-10-11 2023-06-13 Plethy, Inc. Devices, systems, and methods for adaptive health monitoring using behavioral, psychological, and physiological changes of a body portion
WO2019109119A1 (fr) * 2017-12-06 2019-06-13 Umweltdata G.M.B.H. Dispositif de mesure de la circonférence d'arbres
JP2020138022A (ja) * 2019-02-27 2020-09-03 国立大学法人信州大学 胎児心拍数測定方法並びに胎児および母体の同時監視方法
CN113693577A (zh) * 2021-08-09 2021-11-26 武汉理工大学 基于光纤传感的胎心监护托腹带
CN113974943A (zh) * 2021-09-30 2022-01-28 湖北佑庭科技有限公司 一种基于光纤传感的监听托腹带及其监测方法
CN113974943B (zh) * 2021-09-30 2024-07-26 湖北民族大学 一种基于光纤传感的监听托腹带及其监测方法

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Publication number Publication date
IL151284A0 (en) 2003-04-10
AU2003249566A1 (en) 2004-03-03

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