EP4054506A1 - Dispositif d'application de stimuli tactiles pendant des phases d'apnée chez des prématurés - Google Patents

Dispositif d'application de stimuli tactiles pendant des phases d'apnée chez des prématurés

Info

Publication number
EP4054506A1
EP4054506A1 EP20803505.5A EP20803505A EP4054506A1 EP 4054506 A1 EP4054506 A1 EP 4054506A1 EP 20803505 A EP20803505 A EP 20803505A EP 4054506 A1 EP4054506 A1 EP 4054506A1
Authority
EP
European Patent Office
Prior art keywords
cuff
pressure
pump
chamber
control device
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.)
Pending
Application number
EP20803505.5A
Other languages
German (de)
English (en)
Inventor
Martin Grunwald
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.)
Universitaet Leipzig
Original Assignee
Universitaet Leipzig
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 Universitaet Leipzig filed Critical Universitaet Leipzig
Publication of EP4054506A1 publication Critical patent/EP4054506A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00—Pneumatic or hydraulic massage
    • A61H9/005—Pneumatic massage
    • A61H9/0078—Pneumatic massage with intermittent or alternately inflated bladders or cuffs
    • A61H9/0092—Cuffs therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00—Pneumatic or hydraulic massage
    • A61H9/0007—Pulsating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/01—Constructive details
    • A61H2201/0173—Means for preventing injuries
    • A61H2201/0184—Means for preventing injuries by raising an alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/1635—Hand or arm, e.g. handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/164—Feet or leg, e.g. pedal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/165—Wearable interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1683—Surface of interface
    • A61H2201/1688—Surface of interface disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5007—Control means thereof computer controlled
    • A61H2201/501—Control means thereof computer controlled connected to external computer devices or networks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5071—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5089—Gas sensors, e.g. for oxygen or CO2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2203/00—Additional characteristics concerning the patient
    • A61H2203/04—Position of the patient
    • A61H2203/0443—Position of the patient substantially horizontal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/06—Arms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/06—Arms
    • A61H2205/065—Hands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/10—Leg
    • A61H2205/106—Leg for the lower legs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/20—Blood composition characteristics
    • A61H2230/207—Blood composition characteristics partial O2-value
    • A61H2230/208—Blood composition characteristics partial O2-value used as a control parameter for the apparatus

Definitions

  • the invention provides a device for the application of tactile stimuli in apnea phases of premature infants, having at least one pump, at least one pressure detection sensor, at least one cuff having at least one chamber, and at least one flexible line which connects an outlet of the at least one pump to the at least a cuff connects and can be filled and emptied with a fluid via the at least one chamber of the at least one cuff, wherein the pressure generated in the at least one cuff can be measured with the at least one pressure detection sensor, as well as a control device; wherein the at least one pump is configured to fill and empty the at least one chamber of the at least one cuff.
  • the invention further relates to a cuff for use in the device according to the invention, as well as a method for controlling the device during apnea phases in premature infants.
  • apnea attacks which can occur up to 20 times an hour. These respiratory arrests are life-threatening. In a newborn intensive care unit, therefore, children's breathing is often artificially supported.
  • conventional ventilation machines respirators
  • respirators are usually used, which either take over the complete ventilation of the premature baby (patient) or mechanically support their spontaneous breathing.
  • non-invasive artificial ventilation in which a mask is placed over the patient's mouth and nose, and invasive artificial ventilation via a tube that is pushed through the mouth or nose into the windpipe. With both measures, however, the risk of injury is high, especially in premature babies.
  • FIG. 8 of US Pat. No. 4,694,839 A A corresponding embodiment is shown in FIG. 8 of US Pat. No. 4,694,839 A, according to which a membrane is expanded by means of compressed air, which in turn moves a piston and an elastic element in the direction of the sole of the foot of the premature baby.
  • the pressure stimulation to restart breathing occurs only selectively via a pressure point.
  • a spring causes the diaphragm and piston to move away from the sole of the premature baby's foot.
  • US 5555891A discloses the stimulation by an unspecified vibrating element in contact with the hand or foot of the premature baby, which in one embodiment could be wireless. Nevertheless, the vibrating element is in any case an electrical conductor and thus in itself represents an increased risk. For this reason, too, the device would have to be removed before using diagnostic imaging methods. The vibration is very high with a frequency of 260 Hz and also generates noises that could disturb the newborn.
  • CN 103142395 B describes a device that can be strapped around the foot and stimulates with gentle pushes against the sole.
  • the sensitive skin of the premature baby could also be stressed too much by shock loads.
  • US 5277194 A describes a breathing monitor and stimulator in the form of a chest strap, a pressure sensor being contained in the chest strap.
  • the pressure sensor is used to measure changes in pressure on the chest strap that occur as a result of changes in breathing and thus changes in the movements of the chest on the chest strap.
  • the pressure sensor in US 5277194 A is only used to monitor breathing.
  • the chest strap contains a large number of electronic components for carrying out the respiratory monitoring, among other things, when a respiratory arrest is detected, acoustic signals are generated on the chest and consequently directly on the patient's body.
  • US 3942513 describes a breathing monitor and stimulator in the form of an air cushion that is placed under the premature baby. This air cushion only works in the supine position and is therefore not independent of the position. In addition, when air is blown into the air cushion near the head / ears, acoustic stimulation occurs. This is undesirable and annoying, especially in premature babies.
  • WO 2020/113350 describes a type of chest strap that is intended to trigger a tactile stimulus on a child's back.
  • the structure only works in the supine position and is limited to the child's sleep phases. Any movement of the child prevents the application of targeted tactile stimuli, so that no position-independent and stable prevention of apnea phases is possible.
  • the known devices mostly contain a device that recognizes an apnea, a control that connects a stimulator and a stimulus transmitter on the patient. Vibrating or at least electrically driven components are often used in combination with mechanical components for stimulation, which, however, have a number of disadvantages.
  • the object of the invention was therefore to provide a device for applying tactile stimuli during apnea phases of premature infants which does not have the disadvantages of the prior art.
  • the object of the invention is achieved by a device according to claim 1, a cuff according to claim 11 and a method according to claim 22.
  • the invention provides a device for applying tactile stimuli during apnea phases of premature infants, comprising: at least one pump, at least one pressure sensor, at least one cuff having at least one chamber, and at least one flexible line which has an output of the at least one pump connects to the at least one cuff and can be filled and emptied with a fluid via the at least one chamber of the at least one cuff, wherein the pressure generated in the at least one cuff can be measured with the at least one pressure sensor, as well as a control device; wherein the at least one pump is configured to fill and deflate the at least one chamber of the at least one cuff.
  • control device is preferably configured to control the filling and emptying of the at least one chamber of the at least one cuff with the at least one pump, in particular in the case of semi-automatic or automatic control of the at least one pump.
  • control device of the device according to the invention has a display which is set up to display the applied pressure and frequency. Consequently, pressure strength and frequency can be varied by manual operation, semi-automatic or automatic control or operation of the pump.
  • This has the advantage that when it is found that the stimulation is in a premature baby is not successful, the pressure can be changed, for example increased. Minimum and maximum print strengths can be set and saved variably. The same applies to the changes in the printing frequency.
  • the changes and adjustments to the pressure intensity and the pressure frequency are made automatically as a function of the apnea state of the premature baby that has been determined.
  • an apnea detection system operating in parallel supplies the data required to control the start and end of automatic stimulation.
  • the control device of the device of the invention can furthermore have a memory which is set up to store the pressure data measured by means of the pressure detection sensor.
  • the device of the invention has a monitoring system for case documentation, the control device being connected to the monitoring system via an interface and the interface being set up to receive the measurement data stored in the control device for the pressure (duration, Pressure intensity, frequency) to the monitoring system.
  • the control device is optionally set up to interrupt the pressure supply, i.e. the supply of the fluid into the chamber (s) of the cuff (s) when a pressure of 770 mbar is exceeded.
  • Interface in the sense of the invention is understood to mean a hardware interface that connects the control device to the monitoring system.
  • the connection between the control device and the monitoring system can either be wired via a hardware adapter or digitally, such as via Bluetooth, Infrared Data Association (IrDA) or Wireless Local Area Network (WLAN or Wi-Fi).
  • IrDA Infrared Data Association
  • WLAN Wireless Local Area Network
  • the control device is, for example, a control computer or a process computer, wherein the control computer or process computer can also be the control unit of an incubator for premature babies connected to the device according to the invention.
  • the control device preferably comprises a conventional processor, a pressure detection sensor and software for controlling the components and signal conversion.
  • the pressure detection sensor is preferably a differential pressure detection sensor which has high sensitivity.
  • the pressure changes measured with the pressure detection sensor can preferably be converted by means of the control device into control signals for controlling the at least one pump.
  • the pressure decrease for the pressure detection sensor can be done via the flexible line, with the at least one pump is connected to the at least one chamber of the cuff.
  • the at least one pressure detection sensor is preferably part of the control device and not the at least one cuff.
  • the preferred pressure strength and frequency of the applied tactile stimulus which is intended to lead to renewed spontaneous breathing and termination of the apnea, is controlled via the pressure detection sensor according to the invention.
  • tactile perception is understood to mean the surface sensitivity of the skin, the sense of touch and sensation. Different stimuli such as touch, pressure, temperature and pain are perceived via different receptors in the skin. Accordingly, a tactile stimulus within the meaning of the invention is a stimulus that is triggered by the action of touch, pressure and / or temperature on the premature baby. Pressure stimuli and / or temperature stimuli are preferred. In one embodiment of the invention, pressure stimuli are particularly preferred. Pressure stimuli can be applied to body parts of the premature baby, for example, through the action of pressure and subsequent pressure changes. Temperature stimuli can be triggered by temperature changes in the fluid in the at least one chamber of the at least one cuff.
  • the device preferably has at least one cuff.
  • the device has a plurality of cuffs, particularly preferably 2 to 10 cuffs, in particular 2, 3 or 4 cuffs. This makes it possible to apply tactile stimuli to different parts of the body of a premature baby, whereby the breathing of the premature baby can be stimulated more effectively and safely during apnea phases.
  • the cuff for applying tactile stimuli during apnea phases of premature infants preferably has at least one chamber and at least one flexible line, the at least one chamber being fillable and emptying with a fluid via the at least one flexible line.
  • the cuff can be a foot, leg, arm or hand cuff.
  • the cuff is in a preferred one Embodiment no breast cuff.
  • an ankle cuff is particularly preferred, since practical investigations, as described, for example, in Example 1, have shown that premature babies in apnea states react particularly sensitively to foot massages.
  • Another possibility is the use of several cuffs on different parts of the body of the newborn, especially if this means that different pressure levels and frequencies can be applied to different parts of the body.
  • the device according to the invention has, in a further preferred embodiment, further pumps and pressure detection sensors. It is particularly preferred if each cuff or each chamber of a cuff is connected to a pump and can be separately filled with a fluid and emptied again. It is also particularly preferred if the pressure in each cuff or each chamber is controlled by a separate pressure detection sensor. For this purpose, the device according to the invention has a corresponding number of pressure detection sensors. This enables individual control and filling of the chambers or cuffs with different pressure levels and frequencies in order to treat apnea phases more effectively.
  • the cuff in particular the foot cuff, has a means for preventing slippage on the body of the premature baby.
  • This means can be, for example, a band attached to the cuff with a fastener, such as a Velcro fastener or another conventional fastener, which is placed around the ankle in the case of an ankle cuff or around the wrist of the premature baby in the case of a hand cuff.
  • the cuff has exactly one chamber which can be alternately filled and emptied with a fluid.
  • This chamber can be designed in such a way that it encompasses the entire cuff, that is to say that the one chamber represents the cuff, so to speak.
  • the cuff more than one chamber, preferably 2, 3, 4 or more chambers, which can be alternately filled and emptied with a fluid.
  • the cuff can be tubular, band-shaped or a closed ring.
  • cuffs of different sizes can be provided.
  • size is understood to mean, for example, the width of the band of a band-shaped cuff or the hose diameter of a hose-shaped cuff or the diameter of the ring containing the at least one chamber, an annular cuff.
  • the cuff according to the invention does not provide punctual but extensive pressure stimulation over the entire area of the cuff.
  • the cuffs according to the invention can be used regardless of the body position of the premature baby and do not generate any disruptive acoustic stimuli.
  • the at least one pump is preferably a hydraulic or pneumatic pump, such as a hose or roller pump, which can be controlled or operated manually, semi-automatically or automatically.
  • Conventional hydraulic or pneumatic pumps can in principle be used in the device according to the invention.
  • the person skilled in the art is able to select and provide suitable pumps in relation to the medium to be conveyed, the delivery rate and the pressure intensity for use in the device according to the invention.
  • the pump can be controlled or operated manually.
  • the pumping frequency and pressure level are specified by the medical personnel using the manual pumping process.
  • the pump has, for example, a pump handle with which a piston of the pump can be actuated.
  • the applied pressure is measured by a pressure detection sensor and visualized on a screen display of the pump. By visually checking the pressure display, the applied pressure can be increased or decreased by the medical staff during manual pump operation.
  • the pump can be controlled or operated semi-automatically.
  • the device is switched on and off manually, but the pump is activated automatically by the control device.
  • the at least one pump can be switched automatically, the device according to the invention is set up in such a way that the at least one pump after detection of a life-threatening change in physiological parameters, such as an oxygen deficiency, bradycardia or changes in the raising and lowering of the chest as an indication of changed breathing Premature infants, is controlled by the control device and the pump alternately filling and emptying at least one chamber of at least one cuff for the application of tactile stimuli during apnea phases of premature infants with a fluid with a predetermined frequency and a predetermined pressure strength.
  • physiological parameters such as an oxygen deficiency, bradycardia or changes in the raising and lowering of the chest as an indication of changed breathing Premature infants
  • the device according to the invention can have a warning device and / or be connected to at least one warning device.
  • a warning device and / or be connected to at least one warning device.
  • the warning means can, for example, be an acoustic (sound) or optical (warning light or warning display on a computer screen) or a combination thereof.
  • warning message is given and an acoustic warning signal is given at the same time on the computer screen of a control unit which is connected, for example, to an incubator for premature babies.
  • the warning signal can also be a vibration alarm that is triggered on a mobile phone or another terminal device with which the medical staff is equipped.
  • the fluid for filling and emptying the at least one chamber can preferably be pumped.
  • Suitable fluids are, for example, gases, liquids, gel-like media and viscous media.
  • gas in the context of the invention also includes gas mixtures. Suitable gases for use in the device and cuff according to the invention are, for example, oxygen, nitrogen or noble gases or mixtures thereof.
  • liquid in the context of the invention also includes liquid mixtures.
  • Suitable liquids for use in the device according to the invention and Cuffs are non-reactive liquids, ie liquids that will not damage or irritate human skin on contact.
  • a preferred liquid is water. Purified water or distilled water is particularly preferred.
  • gel is understood to mean a disperse system which consists of at least two components.
  • the solid component forms a sponge-like, three-dimensional network, the pores of which are filled with a liquid (lyogel) or a gas (xerogel).
  • xerogels are aerogels, in which the network is highly porous and air is the stored gas.
  • the chamber (s) are preferably filled and emptied with a gas, more preferably with a gas mixture, particularly preferably with air.
  • each chamber is connected to the at least one pump via at least one flexible line.
  • each chamber is connected to a separate pump via a flexible line.
  • each cuff is connected to at least one pump via at least one flexible line.
  • the device of the invention has 2, 3 or 4 flexible lines, each of which connects an outlet of the at least one pump to one of the 2, 3 or 4 sleeves and each of the 2, 3 or 4 via the at least one chamber Cuffs can be filled and drained with a fluid. It is particularly preferred if each chamber of each cuff is connected to the at least one pump via at least one flexible line. It is also particularly preferred if each chamber of each cuff is connected to a respective pump via at least one flexible line.
  • the flexible line is preferably a hose made of a material common in medical technology, such as EPDM / PP (ethylene-propylene-diene / polypropylene), FPM (fluororubber), LDPE (low density polyethylene, soft polyethylene) , PUR (polyurethane), PVC-vinyl, TPE (thermoplastic elastomer) or silicone.
  • EPDM / PP ethylene-propylene-diene / polypropylene
  • FPM fluororubber
  • LDPE low density polyethylene, soft polyethylene
  • PUR polyurethane
  • PVC-vinyl polyvinyl
  • TPE thermoplastic elastomer
  • the frequency of the application of tactile stimuli to a relevant part of the body of the premature baby leads to termination of apnea states in the range from 0.11-5.66 Hz, preferably from 0.26 to 3.75 Hz and particularly preferably from 0.92 to 1.01 Hz.
  • the invention therefore provides a device or a cuff, the cuff being set up such that the chambers operate at a frequency in the range from 0.1 Hz to 5.66 Hz, preferably from 0.26 to 3, 75 Hz and particularly preferably from 0.92 to 1.01 Hz can be filled and emptied, whereby the tactile stimulus is applied at this frequency to a relevant part of the body of the premature baby.
  • each individual chamber can be filled and emptied with a frequency in the specified ranges. It is also particularly preferred if, in an embodiment with more than one cuff, each individual cuff can be filled and emptied with a frequency in the specified ranges.
  • the pressure strength of the application of tactile stimuli to a relevant part of the body of the premature infant to end apnea states in the range from 10 to 770 mbar, preferably from 10 to 428 mbar or 11 to 227 mbar and particularly preferred from 110 to 240 mbar.
  • the invention therefore provides a device or a cuff, wherein the cuff is set up so that the chambers with a pressure strength in the range from 10 to 770 mbar, preferably from 10 to 428 mbar or 11 to 227 mbar and especially preferably 110 to 240 mbar can be applied, whereby the tactile stimulus is applied with this pressure strength to a relevant part of the body of the premature baby.
  • each individual chamber can be subjected to a pressure level in the specified ranges. It is particularly preferred if, in an embodiment with more than one cuff, each individual cuff can be filled and emptied with a frequency in the specified ranges. Throttled chambers in the cuff are also conceivable so that certain patterns can be generated in the pressure distribution. A throttling of the chamber pressure in the cuff can be achieved by using various materials that contain the chambers or of which the chambers are made. Diaphragms made of a plastic or rubber allow the chambers to be throttled.
  • the throttling of the chambers can also be achieved by using a separate feed line for a flexible pipe for each chamber and individual control of the associated pump, whereby different pressure levels can be applied to individual chambers.
  • pressure strength and “pressure” are used synonymously for the purposes of the invention. This is explicitly not the pressure that is generated by the premature baby through its own breathing, but rather the pressure generated by the at least one pump of the device according to the invention to stimulate the resumption of breathing during apnea phases in premature babies.
  • variable and / or stochastic cycles is understood to mean a constant change in the pressure intensity, duration and frequency of the tactile stimuli in order to prevent the premature baby from getting used to rhythmic stimuli.
  • the effect of the tactile stimuli on the relevant part of the preterm baby's body, i.e. the alternating filling and emptying of the chamber (s) of the cuff, is activated as soon as possible after the required oxygen saturation has been reached, i.e. a target value for the oxygen partial pressure in the blood of the preterm baby and / or the reinsertion independent breathing, ended.
  • each chamber can be controlled separately so that a separate pressure stimulus with a separate pressure intensity and frequency can be implemented in each chamber.
  • each cuff can also be activated separately so that a separate pressure stimulus with a separate pressure intensity and frequency can be implemented in each cuff.
  • Further treatment beyond that would be avoided in everyday clinical practice since every touch stimulus in premature babies is potentially also a pain stimulus, since the skin of premature babies is extremely thin.
  • the treatment is ended by the medical staff switching off the at least one pump. If a clinical monitoring system is available, the at least one pump is automatically switched off as soon as the apnea phase has ended or the physiological parameters of the child have reached normal values.
  • the cuff is free of electrical or electronic components.
  • the corresponding sensors are present in the control device of the device according to the invention and / or in the clinical monitoring system of the incubator with which the device according to the invention is connected.
  • Other sensors can be located directly on the premature baby's body.
  • these sensors are not part of the cuff according to the invention, but rather with separate means attached separately to the body of the premature baby.
  • An example of such separate sensors are temperature sensors on the body of the premature baby.
  • the pressure sensing sensor of the device according to the invention measures the pressure that is generated to fill the chamber (s) of the at least one cuff, ie the pressure that should lead to resumption of breathing, this pressure being determined on the basis of the stimulation carried out by the pump .
  • the data from separate sensors can, however, be passed on to the control device of the device according to the invention.
  • the separate sensors can send their data to a monitor system, the monitor system recording all incoming data or using it to control other, external devices.
  • the monitor system can emit an acoustic or other type of warning signal and control the oxygen supply devices in such a way that the premature baby is supplied with more oxygen. Data can also be exchanged between the pump and the monitor system and used for control purposes. In the device according to the invention, the monitor systems therefore exercise monitoring, storage and control functions, but not the cuffs.
  • the cuff according to the invention preferably consists of a conventional, sterilizable and elastic material or is designed as a disposable cuff.
  • the material of which the at least one chamber of the cuff is made is preferably impervious to the fluid with which the chambers of the cuff can be filled, such as, for example, gas-tight and / or liquid-tight.
  • the cuff can have conventional fasteners, such as a Velcro fastener or the like.
  • the tactile stimulation on the foot of premature infants could be optimized so that the stimulation does not harm the premature infant, ie the tactile stimulation occurs with a randomly varying frequency in the range from 0.1 Hz to 5.66 Hz and / or with a randomly varying pressure in the range from 10 to 770 mbar.
  • the cuff only needs to be applied once to the premature baby, preferably to the foot. To prevent slipping or slipping, the slipping protection of the cuff is used in a previously unique way.
  • the incubator no longer has to be opened to treat the apnea phases. As a result, there is less heat loss and moisture loss from the incubator and the risk of germs entering can be reduced.
  • the pumps which are part of the device according to the invention, are located outside the incubator and can be installed in such a way that they do not generate any noise emission into the incubator.
  • the device according to the invention makes it possible for the first time to replace a method that has been used very successfully so far, but which is carried out and controlled purely subjectively, by an objective method, whereby human errors can be excluded.
  • the cuff has no mechanical components. In contrast to the solutions known from the prior art, this prevents mechanical parts from penetrating too far into the patient's foot / body in the event of excess pressure or malfunctions and thereby leading to injuries. Accordingly, in a particularly preferred embodiment, the cuff according to the invention is free of mechanical components.
  • mechanical component is understood to mean the smallest component that can no longer be sensibly dismantled and is used again and again in the same or similar form in a technical area of application. This includes both individual components such as screws, pins, shafts, gears, springs, etc., as well as components that consist of several individual components, but are used as a single component in terms of their use, such as roller bearings, clutches, valves, etc. As a rule, mechanical components contain parts that are made of a metal.
  • the cuff according to the invention is designed in such a way that injuries to the premature baby are avoided as far as possible. Injuries could also be caused, among other things, by the fact that, in the event of a defect, too high a pressure is built up in the at least one chamber of the cuff, which is transmitted to the foot of the premature baby. This could lead to unwanted bruises. Even the uncontrolled bursting the chambers can lead to injury to the premature baby.
  • the cuff is therefore designed so that the medium escapes in a controlled manner in the event of a malfunction of the device or cuff according to the invention when a pressure of more than 770 mbar (577.547 mm Hg) is reached in the at least one chamber.
  • controlled escape means that the connection points or surfaces, such as, for example, adhesive surfaces, seams or weld seams, with the aid of which the at least one chamber of the cuff is formed, dissolve. Practical experience has shown that at a pressure below 770 mbar in the at least one chamber, no damage or injuries occur to the premature baby.
  • the device according to the invention is preferably connected to or can be used together with a conventional incubator and / or warming bed for premature babies.
  • the invention therefore provides an incubator for premature infants which has the device according to the invention.
  • any conventional incubator for premature babies is suitable for combining the device according to the invention.
  • Any necessary adjustments to conventional incubators in order to connect the device according to the invention to an incubator or to integrate it into it are of a rather minor nature and can be carried out by the person skilled in the art on the basis of his general specialist knowledge.
  • the invention further relates to a method for controlling a device for applying tactile stimuli during apnea phases of premature infants after an alarm has been triggered, in particular an oxygen alarm.
  • the invention provides a method for controlling a device for the application of tactile stimuli during apnea phases of premature infants after an alarm has been triggered, the device having at least one pump, at least one pressure sensing sensor, at least one cuff having at least one chamber, and at least one flexible line which connects an outlet of the at least one pump to the at least one cuff and can be filled and emptied with a fluid via the at least one chamber of the at least one cuff wherein the pressure generated in the at least one cuff can be measured with the at least one pressure detection sensor, as well as a control device; wherein the at least one pump is configured to fill and empty the at least one chamber of the at least one cuff, and the method comprises the steps of:
  • Detecting an alarm alternating filling and emptying of the at least one chamber of the at least one cuff with a fluid by means of the at least one
  • each chamber is preferably filled and emptied with the specified frequency and / or the specified pressure strength.
  • Each chamber can preferably also be filled and emptied with a different frequency and / or pressure strength.
  • the method can be carried out manually.
  • the medical staff operates the pump of the device mechanically or manually after the alarm has been detected, for example by the clinical monitoring system in the premature baby.
  • the device of the invention comprises in this embodiment a manual pump, a control device with pressure detection sensor, the control device for measuring the Pressure strength and is configured for recording or storing the measurement data of the pressure.
  • the pumping frequency and pressure level are specified by the medical staff using the manual pumping process.
  • the applied pressure is measured by a pressure sensor and visualized on a display of the device. By visually checking the pressure display, the applied pressure can be increased or decreased by the medical staff during manual pump operation.
  • the display also shows the duration of the stimulation.
  • the method can be carried out semi-automatically.
  • the method is started after an alarm, for example by the clinical monitoring system in the premature baby, by manual switching on of the at least one pump by the medical operating personnel.
  • the pump frequency and the pressure intensity are automatically regulated by the control device during the phase of application of the tactile stimuli.
  • the method is ended manually by the medical staff switching off the at least one pump after the required oxygen saturation has been achieved and breathing is resumed in the premature baby. If the control device is set up to store the measurement data of the pressure, these pressure data can be forwarded via a corresponding interface to the clinical monitoring system for case documentation.
  • the method can be carried out automatically.
  • the pump is automatically controlled by the control device, taking into account the physiological-technical parameters. This means that the switching on, pressure intensity and frequency during operation of the pump and switching off of the pump take place automatically with this alternative without manual intervention by the operating personnel.
  • the detection of the alarm can be done by the staff with manual or semi-automatic control.
  • the alarm signal is (automatically) forwarded to the control device and recorded by it.
  • control device of the device according to the invention has a corresponding interface
  • the print data can be forwarded to the clinical monitoring system for case documentation.
  • the control device is optionally set up to control the pressure supply, ie the supply of the fluid in to interrupt the chamber (s) of the cuff (s) when a pressure of 770 mbar is exceeded.
  • the display of the control device shows the current pressure of the at least one chamber, the duration of the stimulation and the applied pressure frequency.
  • the method is started in all variants of the method, ie either manually or automatically, after a life-threatening change in physiological parameters such as an oxygen deficiency, bradycardia or changes in the raising and lowering of the chest as an indication of changed breathing and triggering of an alarm, for example by the clinical monitoring system in premature babies.
  • a life-threatening change in physiological parameters such as an oxygen deficiency, bradycardia or changes in the raising and lowering of the chest as an indication of changed breathing and triggering of an alarm, for example by the clinical monitoring system in premature babies.
  • the raising and lowering of the chest is monitored with acceleration sensors, for example.
  • An alarm is triggered when such a life-threatening change in physiological parameters is detected in the premature baby.
  • the procedure is terminated immediately after the required oxygen saturation has been reached, i.e. a target value for the oxygen partial pressure in the blood of the premature infant and / or the resumption of independent breathing, but at the latest after a defined time (for example 30-40 seconds), either manually or automatically, Like previously described.
  • the invention also relates to a method for preventing or treating apnea phases in premature infants by means of the device according to the invention for applying tactile stimuli to premature infants, the device having at least one pump, at least one pressure sensor, at least one cuff having at least one chamber, and at least one flexible Line which connects an outlet of the at least one pump to the at least one cuff and can be filled and emptied with a fluid via the at least one chamber of the at least one cuff, with the at least one pressure detection sensor being able to measure the pressure generated in the at least one cuff, as well as a control device; wherein the at least one pump is configured to fill and deflate the at least one chamber of the cuff, and the method comprises the steps of:
  • tactile stimuli to the premature baby after an alarm has been triggered comprising the steps of: alternating filling and emptying of the at least one chamber of the at least one cuff with a fluid by means of the at least one pump via the at least one flexible line; o with a frequency in the range from 0.1 Hz to 5.66 Hz. o with a pressure strength in the range from 10 to 770 mbar, preferably from 10 to 428 mbar or 11 to 227 mbar and particularly preferably from 110 to 240 mbar, whereby the tactile stimulus is applied to a relevant part of the body of the premature baby with this pressure.
  • the invention relates to the use of the device and / or cuff described herein for preventing or treating phases of apnea in premature infants.
  • Preferred variants of the device according to the invention, the cuff according to the invention and the method according to the invention relate to:
  • Device for applying tactile stimuli during apnea phases of premature babies having at least one pump (30), at least one pressure detection sensor (41), a cuff (10) having at least one chamber (11, 11 '), and at least one flexible line (12, 12') which connects an outlet of the at least one pump (30) to the cuff (10) and via the at least one Chamber (11, 11 ') of the cuff (10) can be filled and emptied with a fluid, the pressure generated on the cuff (10) being measurable with the pressure detection sensor, as well as a control device (40) for controlling the at least one pump ( 30) in the event of an apnea, the control device (40) being configured to control the at least one pump (30) for filling and emptying the at least one chamber (11, 11 ') of the cuff (10).
  • Cuff (10) for applying tactile stimuli during apnea phases of premature infants having at least one chamber (11, 11 '), at least one flexible line (12, 12'), the at least one chamber (11, 11 ') via which at least one flexible line (12, 12') can be filled and emptied with a fluid, characterized in that the cuff (10) has a means (14) for preventing slippage on the body of the premature baby (15).
  • Device or cuff according to item 1 or 2 characterized in that the cuff (10) is a foot cuff, leg cuff, arm cuff or hand cuff, preferably a foot cuff.
  • Device or cuff (10) according to one of the preceding objects, characterized in that the cuff (10) has 2, 3, 4 or more chambers (11, 11 ‘).
  • Device or cuff (10) according to one of the preceding objects characterized in that the cuff (10) is set up so that the chambers (11, 11 ') can be filled and emptied alternately with the fluid.
  • Device or cuff (10) according to one of the preceding items characterized in that the cuff (10) is set up so that the chambers (11, 11 ') with a frequency in the range from 0.1 Hz to 5.66 Hz can be filled and emptied.
  • Device or cuff (10) according to one of the preceding objects, characterized in that the cuff (10) is set up so that the chambers (11, 11 ') can be filled and emptied with a pressure in the range from 11 mbar to 770 mbar are.
  • Device or cuff (10) according to one of the objects, characterized in that the cuff (10) has one or more sensors selected from pressure sensors, heat sensors, movement sensors and sensors for measuring the oxygen saturation of the blood.
  • Device or cuff (10) according to one of the preceding objects, characterized in that the cuff (10) is made of sterilizable elastic material or is designed as a disposable cuff (10).
  • Device or cuff (10) according to one of the preceding objects, characterized in that the cuff (10) has no mechanical components.
  • a method for controlling a device for applying tactile stimuli in apnea phases of premature infants after an alarm has been triggered the device having at least one pump (30), at least one pressure detection sensor (41), a cuff (10) having at least one chamber ( 11, 11 '), and at least one flexible line (12, 12 ') which connects an outlet of the at least one pump (30) to the cuff (10) and can be filled with a fluid via the at least one chamber (11, 11') of the cuff (10) can be emptied, with the pressure sensor measuring the pressure generated on the cuff (10), as well as a control device (40) for controlling the at least one pump (30) in the event of apnea, the control device (40) for controlling the at least one pump (30) is configured for filling and emptying the at least one chamber (11, 11 ') of the cuff (10), and the method comprises the steps of:
  • Figure 1 shows an embodiment of the cuff according to the invention
  • FIG. 2 shows an alternative embodiment of the cuff according to the invention
  • FIG. 3 shows an embodiment of the device according to the invention in an incubator
  • FIG. 4 shows an example of a cuff according to the invention, attached to the foot of a premature baby;
  • Figure 5 is a schematic representation of the test environment.
  • FIG. 6 Tukey box plots of the mean and maximum pressure values of the four
  • the horizontal lines in the boxes mark the medians.
  • the star and the circles outside the boxes indicate outlier values that were not taken into account when determining the median values or the mean values.
  • the boxes represent the middle 50% of the pressure values.
  • Antennas and outliers represent the outer 50% of the pressure values.
  • FIG. 7 A schematic representation of an embodiment of the device according to the invention (shown without a cuff).
  • FIG. 1A shows an embodiment of the cuff 10 according to the invention with a chamber 11 which can be filled and emptied again with a fluid such as a gas, a gel or a liquid.
  • the chamber 11 can be filled with air and emptied again.
  • the chamber is filled and emptied via the flexible line 12, here a hose 12 which is connected to a pump 30 (not shown).
  • the cuff shown in FIG. 1 is a disposable cuff which can be fastened to an extremity of a premature baby 15 by means of a Velcro fastener 13.
  • the cuff contains a band-shaped anti-slip device 14 which can be placed around the ankle or wrist of a premature baby 15 and, in the embodiment shown here, can also be closed by means of a Velcro fastener.
  • the embodiment of the cuff 10 shown here is free of electronic, electrical and mechanical components.
  • FIG. 1B shows an embodiment of the cuff 10 according to the invention as in FIG. 1A, in which, however, the chamber 11, which can be filled and emptied with a fluid such as a gas, a gel or a liquid, encompasses the entire cuff.
  • FIG. 2 shows a cuff according to the invention as in FIG. 1, but in an embodiment with two chambers 11, 11 ', each chamber having a separate one Hose 12, 12 'can be connected to a pump 30 (not shown).
  • a pump 30 not shown.
  • Alternative embodiments with three, four or more chambers and the corresponding number of tubes are also possible.
  • FIG. 3 shows an incubator 20 for premature babies 15 which comprises the device according to the invention with a pump 30 and a control device 40.
  • a pressure detection sensor 41 is contained in the control device 40.
  • the premature baby 15 located in the incubator has a cuff 10 on its foot, which is connected to the pump 30 and the control device 40 via an air hose 12.
  • the embodiment of the device according to the invention shown here is an automatically operating device.
  • the pump 30 is activated by the control device 40 and the chamber 11 of the cuff 10 is alternately filled and emptied with air by means of the pump 30 via the air hose 12.
  • the alternating filling and emptying of the chamber 11 is carried out at a frequency in the range from 0.1 Hz to 5.66 Hz.
  • the chamber 11 of the cuff 10 is filled, the chamber 11 is subjected to a pressure in the range from 11 mbar to 770 mbar.
  • the pressure in the cuff 10, i.e. the pressure exerted on the foot of the premature baby 15, is measured with a pressure detection sensor 41 in the control device 40.
  • the pump 30 is automatically switched off by the control device 40 immediately after the required oxygen saturation has been reached, i.e. a target value for the oxygen partial pressure in the blood of the premature baby 15 and the resumption of independent breathing.
  • FIG. 4 shows the cuff 10 according to the invention, attached to the foot of a premature baby 15.
  • the cuff 10 is connected via the hose 12 to a pump 30 (not shown) and secured with the band 14 against falling off or slipping.
  • FIGS. 5 and 6 are explained below in connection with Example 1.
  • FIG. 7 shows a device with an on / off switch 31 and a display 32 as a display for the pressure level. Medical personnel manually turn the device on and off.
  • the device contains a control device 40 with a pressure detection sensor 41 and a memory unit, the pressure intensity being measured with the pressure detection sensor 41 and the memory unit being configured for recording or storing the measurement data of the pressure.
  • the pump 30 is switched on manually by the medical operator when an oxygen alarm is triggered.
  • the pump is automatically controlled by the control device 40, ie the pump frequency and pressure intensity are regulated by the control device 40.
  • the method is terminated manually after the required oxygen saturation has been reached and breathing is resumed in the premature baby, but at the latest after a defined time (for example 30-40 seconds) automatically.
  • the device can optionally contain a data port as a digital or hardware interface 34 for forwarding the print data to the clinical monitoring system for the purpose of case documentation.
  • the device is connected to a cuff 10 via the hose 12.
  • the device can be attached directly to a medical device, such as an incubator, or it can be detachable. In the latter case, the device is subject to stresses caused by movement by the medical operating personnel.
  • the embodiment of the device shown here therefore has a bending protector 16 to protect the hose 12. Power can be supplied via a cable 33.
  • Example 1 Study to characterize the tactile stimulation carried out by medical staff in apnea states of premature infants
  • the pressure levels of nurses when performing foot massages in apnea conditions were analyzed using a premature infant model.
  • This premature infant model was equipped with a sensor system to measure the stimulus pressure and to measure the frequency of the tactile stimulation. In this way, the minimum and maximum massage pressures and their scatter values as well as the range of the stimulation frequency for tactile foot stimulation in apnea states of premature infants could be determined.
  • the hand positions and the stimulation modes of the nurses were also recorded. 70 participants took part in the experiment. It was also analyzed whether The mode and intensity of tactile stimulation can be influenced by work experience and age.
  • tactile stimulation is common practice, the style and intensity of tactile interventions have not yet been studied. Even if these measures are used to treat very critical situations during apnea, the treatment approach is very subjective. If the apnea is left untreated, side effects can occur for life. This means that it is unclear which techniques and pressures are used by medical staff and whether they differ in their effectiveness. It can therefore be assumed that every medical employee has different, individual ideas of gentle or strong tactile stimulation. So far, no attempt has been made to objectively measure the different pressure intensities that are used to treat central apnea in premature infants. There is also no classification of the different types of tactile foot stimulation.
  • a small baby doll was used as the basis for the model.
  • the hollow polyvinyl chloride (PVC) frame of the doll was filled with small sandbags to accommodate the weight of a premature baby of 1000 g.
  • a water-filled bag (31.1 mm x 38.2 mm x 9.1 mm) was attached to the sole of the right foot ( Figure 5), which was connected to a pressure sensor (24PCCFA6D, Honeywell Int. Inc.) and with the the pressure exerted on the bag was measured (measuring range: ⁇ 1034.21 mbar).
  • the sensor output was registered by a Sigma / Delta analog-to-digital converter (MCP3423-E / UN, Microchip Technology Inc.) with a resolution of 14 bits and an average sampling rate of 60 samples per second.
  • the infant model and measuring devices were placed in a state-of-the-art incubator.
  • the manual stimulation process was recorded via a webcam (Logitech C270; 640 x 480pixel; 30 images per second) which was attached to the incubator wall with a suction flange.
  • the video data was used to classify hand and finger positions during foot stimulation (stimulation modes).
  • ICU intensive care unit
  • IMG intermediate care unit
  • a handedness test was carried out (8). All participants were right-handed. All tests were performed between 12:30 p.m. and 3:00 p.m. during the shift changeover.
  • Frictional movements were performed by 81.4% and 80% of the participants during the LIA and HIA, respectively. In both LIA and HIA, 14.3% pressed the foot. The remaining 4.3% (LIA) and 5.7% (HIA) participants performed tickling or tapping stimulations (Table 1). The pressure was statistically the same for the friction and squeeze stimulation (see Table 2).
  • the participants used six different finger positions or movements: squeezing the sole of the foot with the tips of the thumbs, massaging the sole of the foot with the thumb, pressing the entire foot with the hand, rubbing the sole of the foot with one or more fingers, tapping or tickling the sole of the foot.
  • the mean pressure values varied strongly between test persons and fingers and ranged from 11.11 to 226.87 mbar during the LIA and from 9.89 to 428.15 mbar during the HIA (FIG. 6).
  • Table 1 Mean and maximum stimulus pressure in millibars of the various stimulation modes and their frequency.
  • M medium pressure between participants
  • SD standard deviation
  • SDmax standard deviation of Mmax
  • Table 2 Comparison of the applied pressure in millibars when rubbing and squeezing.
  • HIA mean median _ 148.56 _ 108.41 0.186
  • LIA low intensity apnea
  • HIA high intensity apnea
  • Mean mean pressure values per person
  • Max maximum pressure values per person
  • Table 3 Groups compare: mean and maximum stimulus pressure in millibars of ICU and IMC participants.
  • LIA mean median 51.87 50.83 0.388
  • HIA mean median 117.72 88.08 0.172
  • the present study was designed to use a manikin to analyze the different types of tactile stimulation used to terminate premature apnea and to measure the pressure intensity and frequency of these stimulations.
  • rhythmic stimulation movements with a mean frequency of about 1 Hz.
  • Different modes rubbing, squeezing, tickling and tapping
  • finger positions were used.
  • the differences in stimulus pressures depend on the apnea intensity and range from 11.11 to 226.87 mbar at low intensity and from 9.89 to 428.15 mbar at high intensity.
  • the variance in stimulus pressure between the test subjects could not be explained by work experience.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rehabilitation Therapy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

L'invention permet d'obtenir un dispositif d'application de stimuli tactiles pendant des phases d'apnée chez les prématurés (15), ayant - au moins une pompe (30), - au moins un capteur de détection de pression (41), - au moins un manchon (10) comportant au moins une chambre (11, 11'), et - au moins une conduite flexible (12, 12') qui relie une sortie de la ou des pompes (30) au ou aux manchons (10) et par l'intermédiaire de laquelle au moins une chambre (11, 11') du ou des manchons (10) peut être remplie et vidée d'un fluide, la pression générée au niveau du ou des manchons (10) peut être mesurée avec le ou les capteurs de détection de pression (41), et - un dispositif de contrôle, la ou les pompes (30) étant configurées pour remplir et vider la ou les chambres (11, 11') du ou des manchons (10). L'invention concerne en outre un manchon (10) destiné à être utilisé dans le dispositif selon l'invention, ainsi qu'une méthode de contrôle du dispositif lors de phases d'apnée chez les prématurés (15).
EP20803505.5A 2019-11-06 2020-11-05 Dispositif d'application de stimuli tactiles pendant des phases d'apnée chez des prématurés Pending EP4054506A1 (fr)

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Citations (2)

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