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WO2001050953A1 - Detecteur a contact de succion, notamment pour mesures non-invasives sur un foetus, telles que frequence du pouls - Google Patents

Detecteur a contact de succion, notamment pour mesures non-invasives sur un foetus, telles que frequence du pouls Download PDF

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Publication number
WO2001050953A1
WO2001050953A1 PCT/EP2000/000089 EP0000089W WO0150953A1 WO 2001050953 A1 WO2001050953 A1 WO 2001050953A1 EP 0000089 W EP0000089 W EP 0000089W WO 0150953 A1 WO0150953 A1 WO 0150953A1
Authority
WO
WIPO (PCT)
Prior art keywords
contact
suction
suction head
fetus
sensor
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/EP2000/000089
Other languages
German (de)
English (en)
Inventor
Alfons Schmid
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.)
Agilent Technologies Inc
Original Assignee
Agilent Technologies Inc
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 Agilent Technologies Inc filed Critical Agilent Technologies Inc
Priority to PCT/EP2000/000089 priority Critical patent/WO2001050953A1/fr
Publication of WO2001050953A1 publication Critical patent/WO2001050953A1/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
    • A61B5/43—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
    • 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
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/252—Means for maintaining electrode contact with the body by suction
    • 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
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
    • A61B5/259—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes using conductive adhesive means, e.g. gels
    • 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
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]

Definitions

  • the present invention relates to sensors with suction contact, in particular for non-invasive fetal measurements such as the pulse rate.
  • spiral electrodes or scalpel electrodes. These spiral electrodes have a single or double spiral (helix) at their upper end, which is intended to make electrical contact with the fetus, which is screwed or screwed into the fetus with a manipulator.
  • Surgicraft-Copeland offers another solution, primarily in Great Britain, which makes electrical contact via a curved needle as a closed ring.
  • WO 91/15996 and WO 96/41570 are described, inter alia, in WO 91/15996 and WO 96/41570.
  • These solutions are a suction electrode 10, in which a soft (latex, elastomer), conical and outwardly opening suction body 20, which seals at the edges with a sealing lip 25, is sucked in by a negative pressure and thus adheres to the fetus 30 sucks.
  • a bellows 40 or a piston / cylinder version 50 is proposed, each of which generates the negative pressure in the absorbent body 20 from outside the womb with the aid of a hose 60. '
  • An electrical contact to the fetus 30 is generated with a metal body 70 with a cable connection 80.
  • the metal body 70 located in the middle of the suction body is pressed against the body of the fetus 30.
  • the suction element 40 or 50 for generating the negative pressure and the associated connecting hose 60 must remain connected to the suction body 20 in order to
  • the invention solves this problem on the one hand by providing an improved structure of the electrode suction head, which does not require any further external means for producing and maintaining a negative pressure, and on the other hand by using a contact compound for mechanical sealing of the absorbent body and / or for electrical contacting.
  • a contact compound for mechanical sealing of the absorbent body and / or for electrical contacting are preferably used in combination, but they can also be used independently.
  • the improved construction of a fetal electrode according to the invention works in a similar way to the known electrodes shown in FIG. 1 with the principle of creating a negative pressure for establishing a contact between the
  • Electrode and the fetus Electrode and the fetus.
  • the negative pressure in the suction head 20 of the electrode facing the fetus 30 is generated and maintained by external means 40 or 50 located outside the womb, according to the invention such external means are completely eliminated, and the negative pressure in the suction head becomes brought about solely by mechanical actuation of the suction head.
  • the suction head according to the invention allows a volume reduction, e.g. by squeezing, its elastic structure, however, opposes the volume reduction and essentially tries to return to its starting position and thereby increase its volume again.
  • a volume reduction e.g. by squeezing
  • the air in the suction head is displaced and pushed out of the suction head via a valve.
  • the elastic body of the suction head expands again counter to the pressing direction, thereby increasing its volume.
  • the valve blocks the gas supply back into the suction head, so that due to the volume expansion of the suction head, a negative pressure is created in the suction head, which can be used to attach the suction electrode to the fetus.
  • This negative pressure is maintained until air, for example, penetrates the suction head through the seal between the fetus and the suction head. No special measures or external means to maintain the negative pressure are required. If the negative pressure subsides, the electrode can be re-attached by pressing or the negative pressure can be increased.
  • the suction head is provided with a bellows which, when compressed, elastically reduces the volume of the suction head and, when the contact pressure is removed, again endeavors to return to its starting position.
  • the suction electrode according to the invention thus leads to smaller and easier-to-apply units which, because of the lack of external means for producing a negative pressure, can also withstand greater tensile and bending stresses. As a result, the birth process is hampered as little as possible, both technically and emotionally. Finally, the suction electrode according to the invention can also be easily released again by opening the valve.
  • the suction head is sealed according to the invention with the aid of an elastic sealing compound with at least a slight adhesive effect, which leads to sticking when contact is formed and can thus also sealingly enclose possibly existing hair.
  • an electrically conductive contacting compound can also be used to improve the electrical contact between the fetus and the electrode. When using an electrically conductive material for the sealing and contacting compound, this can take on the task of both mechanical sealing and electrical contacting.
  • Hydrogels have been shown to be particularly favorable as a use for the contact mass. Hydrogels are highly hydrated, ductile, biocompatible, electrically conductive, sticky, slimy and organic. They meet two conditions:
  • Hydrogels adapt perfectly to any surface shape and have been tested for many applications on and in the human body. Hydrogels consist of water-insoluble polymer molecules, the structural form of which is such that water molecules are built in between the individual polymer molecules in order to obtain a polymer chain.
  • the contact material As a requirement for the contact material, it must be biocompatible, be able to adapt to the shape of the head and, if necessary, the hair, and thus provide the appropriate sealing effect.
  • the contact mass should also have an adhesive effect in order to improve the holding force.
  • the contact mass should also be electrically conductive so that electrical contact can be made with the fetus.
  • Various hydrogels have been shown to be particularly advantageous:
  • PAA Polyacrylamides
  • PHEMA Polyhydroxyethyl methacrylates
  • an outer edge of the suction head facing the fetus is provided with a sealing ring consisting of the contact material.
  • an electrically conductive contact mass (preferably a hydrogel) is used as the contact mass for the sealing ring
  • the electrical contact formation can also take place directly via the outer sealing ring without any further special electrode contact to the fetus being required. This not only allows a further reduction in components, but also makes it unnecessary to make another contact in addition to the sealing contact. From a mechanical point of view, too, the electrical contact along the sealing contact is cheaper than, for example, an extra contact in the center area of the suction head.
  • the sealing contact diminishes, as a result of which the electrical contact is also reduced, this is also noticeable to the outside by a reduction in the adhesion of the entire suction head. If the seal and the electrical contact are separated, however, the seal can be intact while the electrical contact is released. By simultaneously sealing and making electrical contact, the safety and reliability of the electrical contact is significantly increased.
  • a contact compound according to the invention thus not only leads to a significantly increased application safety by improving the adhesive property, but in turn also allows the vacuum requirement to be reduced in order to burden the baby as little as possible.
  • the electrical contact of the electrode to the fetus can be significantly improved in order to get the electrophysiological signal in better quality or to improve the pulse rate measurement by an optical measuring method (such as a pulse sensor, SpO2 sensor). Due to the improved sealing properties of the contact mass, a lower suction volume is usually sufficient to suction the electrode. By suitable selection of a soft ductile material for the contact mass, sufficient electrical contact can be made even with strong hair growth. It can be seen that the inventive provision of the suction head with a contact mass is independent of the principle chosen for producing a negative pressure.
  • the use of a contact material according to the invention can be used in particular in the embodiment of a fetal electrode which is improved according to the invention, but also in the conventional suction electrodes known in the prior art.
  • the aspects according to the present invention lead to a significant improvement in the quality in the determination of the pulse rate of the unborn child and this with improved comfort for mother and clinic staff.
  • the invention has been described with regard to the application for fetal pulse rate measurement, it can be seen that the invention is not restricted to these, but for any form of fetal measurement in which a more or less permanent contact with the fetus is to be established, can be applied.
  • inventive principles can generally be extended to other applications of sensors with suction contact. Examples are: the SpO2 measurement in the reflection method, optical absorption and reflection methods for measuring medical parameters, pH measurement, transcutaneous measurements of oxygen partial pressure (pO2) and carbon partial pressure (pC02) or other transcutaneous parameters, or intracranial pressure when applied the Fontanelle.
  • Figure 1 shows the structure of known fetal suction electrodes
  • Figure 2 shows the structure of a preferred embodiment of a fetal suction electrode according to the invention.
  • FIG. 2 shows the structure of a preferred exemplary embodiment of a fetal suction electrode 200 according to the invention.
  • the suction electrode 200 has a suction head 210 which is applied to a fetus (not shown) with the aid of an insertion tube 420.
  • the suction head 210 has a sealing ring 220 which is preferably wrapped around on three sides and, in the application, is pressed against the unborn child with the open fourth side.
  • the sealing ring 220 is a simple ring, the cross-sectional shape of which can have any shape, but is preferably round or has a rectangular cross-section, preferably with the narrower side up / down, that is to say the wider side in diameter.
  • the sealing ring 220 is preferably made of an elastic material with at least a slight adhesive effect, which leads to easy bonding when contact is formed and thus also sealingly encloses any existing hair.
  • the sealing ring 220 is preferably made of a hydrogel, but other materials can also be used accordingly, which ensure sufficient sealing properties, in particular even in the presence of hair.
  • the suction head 210 also has a suction body 230, which preferably has a shape as a bellows.
  • the absorbent body 230 reduces its volume under the influence of a force in the direction of the arrow.
  • the absorbent body 230 is preferably a soft elastomer part, e.g. B. made of silicone.
  • Other preferred materials for the absorbent body 230 can also be soft PVC, polyurethane (PUR) or (preferably sprayable) elastomers.
  • PUR polyurethane
  • the undercuts resulting from the shape and the bellows can preferably be molded in silicone.
  • the absorbent body 230 closes off from the fetus with a sealing lip 240.
  • the sealing ring 220 nestles against the sealing lip 240.
  • the sealing lip 240 preferably projects slightly beyond the sealing ring 220. The sealing effect of the absorbent body 230 can be decisively improved by the combination of the sealing lip 240 and the sealing ring 220.
  • the sealing ring 220 In order to reduce lateral pushing of the sealing ring 220 or so that the sealing ring 220 cannot be pulled inward by the suction effect, it is preferably embedded in the suction body 230 between a retaining ring 250 and the sealing lip 240 of the suction body 230 and is thus held in position ,
  • valve 270 In a bottom region 260 (that is, in a region facing away from the fetus) of the absorbent body 230 there is a valve 270, which preferably consists of a valve
  • Flap valve 270 becomes the pressure lip 290 when an overpressure builds up in the
  • Absorbent body 230 opened, and the gases in the absorbent body 230 can escape. On the other hand, if the volume of the absorbent body 230 expands again, so that a negative pressure is created in the absorbent body 230, the
  • valve 270 instead of the flap valve 270 shown in FIG. 2, any type of valve can be used, the valve 270 being adapted to the corresponding application and environmental conditions and to the geometric embodiment of the absorbent body 230.
  • a holding ring 300 which serves to let the suction head 210 rest on the insertion tube 420, also adjoins the bottom region 260. At the same time, the retaining ring 300 allows the insertion tube 420 to be easily removed by pulling the insertion tube 220 against the direction of the arrow shown in FIG.
  • a reference contact 310 is also connected to the bottom region 260, which is preferably located in the insertion state between the bottom region 260 and the insertion tube 420.
  • the reference contact 310 preferably a metal ring, serves to establish the electrical contact of the reference electrode.
  • the reference contact 310 is followed, preferably via a metallic connection such as a soldered or welded connection, by a cable 320 which is guided to the outside in a protected manner via the insertion tube 420.
  • Another cable 330 for making electrical contact with the fetus is preferably led into the absorbent body 230 through a recess in the base region 260.
  • the cable 330 is conductively connected to the metal body 70.
  • the sealing ring 220 is made electrically conductive by suitable material selection and itself serves as an electrode opposite the fetus.
  • the cable 330 is connected to the sealing ring 220 in an electrically conductive manner.
  • the sealing ring 220 By pressing the absorbent body 230 against the fetus, the sealing ring 220 now not only provides a seal for the absorbent body 230, but also establishes electrical contact with the fetus. This interaction of densities and electrical contacting of the sealing ring makes it unnecessary to attach a special electrode contact (such as the metal body 70 in FIG. 1) in the absorbent body 230.
  • the cable 330 can of course also be routed outside the absorbent body 230.
  • the insertion tube 420 is used for the targeted and simple insertion of the suction head 210 into the womb towards the fetus.
  • the suction head 210 When the suction head 210 has touched the body of the fetus, the suction head 210 is pressed by means of the insertion tube 420, whereby the volume of the suction body 230 is reduced.
  • the valve 270 opens under the influence of excess pressure when the absorbent body 230 is compressed. During this compression (in the direction of the arrow), the sealing lip 240 and the sealing ring 220 are also pressed against the fetus. If the insertion tube 420 is withdrawn again, the suction body 230 tries to follow this movement.
  • the suction head 220 initially adheres to the fetus. Since the valve 270 now closes, but at the same time the suction body 230 strives to return to its original shape, that is to say expands, a negative pressure is created in the suction body 230, which in turn presses it more firmly against the fetus.
  • the sealing lip 240 By pressing the suction head 210, the sealing lip 240 is opened and the sealing ring 220 mechanically (and possibly also electrically) makes contact with the body of the fetus. Electrical contact to the fetus is made via the electrical conductor of the cable 330 (and the sealing ring 220) and the pulse rate can be measured in a known manner.
  • the suction head 210 is preferably produced by spraying technology, parts such as the cable 330, the reference contact 310 and the valve 270 being able to be injected into the suction body 230 when the latter is being sprayed.
  • the sealing ring 220 must be inserted later.
  • the pressure lip 290 is preferably a simple preformed elastomer plate (preferably silicone).
  • the conductors of the two cables 320 and 330 are preferably treated galvanically in order to avoid corrosion, particularly in a hydrogel environment used as a sealing ring 220.
  • buttons part 340 which can be pressed, glued or otherwise attached to the insertion tube 220.
  • the button part 340 serves to facilitate the application process.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Cardiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Physiology (AREA)
  • Pediatric Medicine (AREA)
  • Reproductive Health (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne une électrode de succion foetale (200) pour mesures non-invasives, en particulier fréquence du pouls, sur un foetus. L'électrode de succion présente une tête de succion (210) pour la production d'un contact de succion au foetus, par formation d'une dépression dans la tête de succion. La tête de succion présente en outre un soufflet pour réduction de volume par compression sous actionnement mécanique. Le soufflet est réalisé élastiquement de façon qu'il s'oppose à la réduction de volume et ait tendance à revenir sensiblement à sa position initiale, permettant ainsi à son volume d'augmenter de nouveau. L'électrode de succion peut en outre présenter une masse de contact élastique (220) ayant au moins une légère action adhésive durant la formation du contact, assurant ainsi l'étanchéité de la dépression. La masse de contact peut être électroconductrice, et un contact électrique approprié correspondant peut être établi avec le foetus par l'intermédiaire de ladite masse de contact (220).
PCT/EP2000/000089 2000-01-07 2000-01-07 Detecteur a contact de succion, notamment pour mesures non-invasives sur un foetus, telles que frequence du pouls Ceased WO2001050953A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2000/000089 WO2001050953A1 (fr) 2000-01-07 2000-01-07 Detecteur a contact de succion, notamment pour mesures non-invasives sur un foetus, telles que frequence du pouls

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2000/000089 WO2001050953A1 (fr) 2000-01-07 2000-01-07 Detecteur a contact de succion, notamment pour mesures non-invasives sur un foetus, telles que frequence du pouls

Publications (1)

Publication Number Publication Date
WO2001050953A1 true WO2001050953A1 (fr) 2001-07-19

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PCT/EP2000/000089 Ceased WO2001050953A1 (fr) 2000-01-07 2000-01-07 Detecteur a contact de succion, notamment pour mesures non-invasives sur un foetus, telles que frequence du pouls

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011107309A1 (fr) * 2010-03-05 2011-09-09 Siemens Aktiengesellschaft Dispositif capteur et procédé permettant d'utiliser le dispositif capteur
SE2050692A1 (en) * 2020-06-11 2021-12-12 Coala Life Ab Fastening device for temporarily fastening a portable sensor device to a human body

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE7207287U (de) * 1972-02-26 1972-05-18 H Sachs Elektronik Kg Elektrodenanordnung fuer ein kardioskop
US4469105A (en) * 1981-06-18 1984-09-04 Clinton Meyering Medical electrode apparatus and kit of components therefor
WO1991015996A1 (fr) 1990-04-19 1991-10-31 Egnell Ameda Limited Sonde medicale non invasive munie d'une ventouse
EP0676170A1 (fr) * 1994-04-04 1995-10-11 Graphic Controls Corporation Sonde à foetus noninvasiblée
WO1996041570A1 (fr) 1995-06-08 1996-12-27 Egnell Ameda Ltd Regulation de flux dans un tube au moyen d'une valve
US5833622A (en) * 1994-04-04 1998-11-10 Graphic Controls Corporation Non-invasive fetal probe having improved mechanical and electrical properties

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE7207287U (de) * 1972-02-26 1972-05-18 H Sachs Elektronik Kg Elektrodenanordnung fuer ein kardioskop
US4469105A (en) * 1981-06-18 1984-09-04 Clinton Meyering Medical electrode apparatus and kit of components therefor
WO1991015996A1 (fr) 1990-04-19 1991-10-31 Egnell Ameda Limited Sonde medicale non invasive munie d'une ventouse
EP0676170A1 (fr) * 1994-04-04 1995-10-11 Graphic Controls Corporation Sonde à foetus noninvasiblée
US5833622A (en) * 1994-04-04 1998-11-10 Graphic Controls Corporation Non-invasive fetal probe having improved mechanical and electrical properties
WO1996041570A1 (fr) 1995-06-08 1996-12-27 Egnell Ameda Ltd Regulation de flux dans un tube au moyen d'une valve

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011107309A1 (fr) * 2010-03-05 2011-09-09 Siemens Aktiengesellschaft Dispositif capteur et procédé permettant d'utiliser le dispositif capteur
SE2050692A1 (en) * 2020-06-11 2021-12-12 Coala Life Ab Fastening device for temporarily fastening a portable sensor device to a human body
SE544782C2 (en) * 2020-06-11 2022-11-15 Coala Life Ab Fastening device for temporarily fastening a portable sensor device to a human body by means of a bellows

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