EP0088704B1 - Isolateur pour le confinement et le transport en atmosphère stérile d'êtres humains, notamment de nouveaux-nés - Google Patents

Isolateur pour le confinement et le transport en atmosphère stérile d'êtres humains, notamment de nouveaux-nés Download PDF

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Publication number
EP0088704B1
EP0088704B1 EP83400485A EP83400485A EP0088704B1 EP 0088704 B1 EP0088704 B1 EP 0088704B1 EP 83400485 A EP83400485 A EP 83400485A EP 83400485 A EP83400485 A EP 83400485A EP 0088704 B1 EP0088704 B1 EP 0088704B1
Authority
EP
European Patent Office
Prior art keywords
temperature
enclosure
atmosphere
heating element
fan
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.)
Expired
Application number
EP83400485A
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German (de)
English (en)
French (fr)
Other versions
EP0088704A1 (fr
Inventor
Gilles Mercey
Claude Picard
Bernard Saint Martin
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.)
Getinge Life Science France SAS
Original Assignee
La Calhene SA
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=9271924&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP0088704(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by La Calhene SA filed Critical La Calhene SA
Publication of EP0088704A1 publication Critical patent/EP0088704A1/fr
Application granted granted Critical
Publication of EP0088704B1 publication Critical patent/EP0088704B1/fr
Expired legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G11/00—Baby-incubators; Couveuses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G11/00—Baby-incubators; Couveuses
    • A61G11/009—Baby-incubators; Couveuses with hand insertion windows, e.g. in the walls
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G2203/00—General characteristics of devices
    • A61G2203/30—General characteristics of devices characterised by sensor means
    • A61G2203/46—General characteristics of devices characterised by sensor means for temperature

Definitions

  • the present invention relates to the field of transport in a sterile atmosphere of human beings who need, for medical reasons, to be confined in a sterile atmosphere and transferred from one place to another within the same hospital, or even on a journey of several tens or hundreds of kilometers, consequently comprising a transport in an autonomous vehicle (automobile, helicopter, plane) without breaking the tightness and sterility of the environment in which they bathe, nor the possibility of medically intervening on them to carry out certain essential emergency treatments.
  • This is the case in particular of individuals who have temporarily lost at least all or part of their immunological defenses and also of certain premature newborns to whom it is necessary to sometimes travel long distances to provide them with treatment for suitable survival.
  • isolators which make it possible to biologically separate a patient completely from the outside, while communicating with him in both directions (entry and exit objects or materials) using waterproof transfer devices or also waterproof intervention devices, some of which such as gloves, diving suits and others can be at least partially an integral part of the wall of the enclosure.
  • An enclosure of this nature is generally ventilated by an air circuit between an inlet and an outlet, each having an absolute filter which stops the entry or exit of any microbial germ.
  • a microbicidal agent circulating in the ventilation circuit for a certain time, such as for example peracetic acid.
  • the present invention specifically relates to an isolator for the containment and transport in a sterile atmosphere of human beings which makes it possible to resolve the above difficulties, using insulator or sealed enclosures of the type mentioned above, using exclusively a battery. accumulators to ensure the operation of the assembly.
  • This insulator of the type which includes, in a known manner, a sealed enclosure, ventilated by a forced circulation of fresh air set in motion by a first fan through an absolute input filter and an absolute filter outlet, fast and watertight transfer devices with the outside for the transfer of material objects, also watertight intervention devices, some of which are an integral part of the wall of the enclosure, is characterized in that it comprises, between the inlet and the outlet of fresh air, a bypass provided with a second fan and a variable temperature heating element , automatically limited to a maximum value of around 120 ° C, so as to create reheating and regulation at a set temperature of the internal atmosphere by partial recycling thereof, all of the energy required to the operation of the installation being supplied by an autonomous storage battery which may be that of the transport vehicle.
  • the automatic limitation to a maximum value of the order of 120 ° C but frequently of 80 ° C or 90 ° C of the variable temperature heating element avoids bringing elements to red in the recycling circuit of the internal atmosphere of the enclosure, which is fundamental in particular when, for biological reasons, the internal atmosphere is enriched with oxygen and could lead to significant ignition risks in the event of a leak.
  • the sealed enclosure thus equipped with its two ventilation and recycling circuits can be moved at will on a simple cart having an autonomous accumulator battery which ensures its independence during different transfers within the same hospital for example . As soon as a transport by vehicle is necessary, one can at will either keep the same accumulator battery which will be asked for an additional contribution of the order of 100 W, or use the battery of this vehicle.
  • the isolator according to the invention has the great advantage of allowing transfer and transport from one sterile chamber to another, located several hundred kilometers away, without ever breaking the seal and the biological sterility of the atmosphere. in which the patient is confined, and this while continuing to administer to him continuously medication and care that he may need.
  • the rotational speeds of the first and second fans are maintained at preset pre-selected values, and the set temperature of the atmosphere of the enclosure is obtained by adjusting the temperature of the heating element simultaneously using, on the one hand, a basic control taking into account the difference between the external and set temperature and the operating or quiescent state of the first fan and, on the other hand, a complementary fine servo loop whose error signal is generated from the difference between the internal and set temperature.
  • the heating element located in the recycling bypass is constituted by power transistors traversed by a current regulated by the basic control and the control loop and whose cooling fins are immersed in the air recycling bypass.
  • the heating element is further equipped with thermistors which vary with temperature and which, if necessary, automatically reduce the current in the power transistors so as to limit the temperature of the heating element to a maximum value of the order of 120 ° C.
  • This design of the embodiment of the heating element makes it possible both to avoid the presence of red dots or sparks, which could occur with ordinary electrical resistances and would lead to very significant risks in the event that a oxygen therapy is necessary for the transported patient.
  • the presence of thermistors which make it possible to limit the temperature to a maximum value of the order of 80 ° C. to 120 ° C. also constitutes security both with regard to the risk of fire and the risk of overheating. of the enclosure.
  • the isolator according to the invention may also include inside the waterproof enclosure a breathing helmet supplied from the outside and which covers the head of the patient in a non-waterproof manner, to condition the nature and / or the hygrometric degree of the atmosphere which it breathes, the consumed part of this atmosphere being, at least in part, discharged directly into the enclosure.
  • This breathing helmet allows, using his ali autonomous mentation sealingly passing through the walls of the enclosure, almost independent respiratory feeding of the assisted patient; it is very useful for all cases where it is desired to provide the patient with a particular respiratory mixture, and in particular for oxygen therapy sessions. It also makes it possible to solve in a simple and elegant way the problem of the hygrometry of the gaseous atmosphere breathed by the newborns; this helmet being simply placed without any particular seal on the patient's head, the latter rejects, directly into the sealed enclosure itself, part of the gases or moisture thus brought, which does not offer serious drawbacks on the hygrometry plan because the portion of the gaseous atmosphere discharged into the enclosure always remains very small and is diluted in the current of the whole.
  • FIG 1 we see a sealed enclosure or insulator 1 of a type known per se and intended for the transport of a newborn 2.
  • the enclosure 1 has a volume of 120 liters.
  • the newborn 2 rests, in the particular case, on a vacuum mattress 3 of a kind known per se and constituted by a number of small diameter plastic balls enclosed in a flexible and waterproof envelope in which there is empties.
  • a vacuum mattress 3 of a kind known per se and constituted by a number of small diameter plastic balls enclosed in a flexible and waterproof envelope in which there is empties.
  • Such a mattress 3 is very useful for molding the shape of the patient's body 2 while ensuring its support and its maintenance in position during variations in acceleration which arise due to transport.
  • the sealed enclosure 1 comprises, in a known manner, a fresh air inlet 4 and waste air outlet pipe 5 on which the absolute filters 6 and 7 are located respectively, the pore size of which is chosen so that they are likely to stop any bacterial transfer.
  • the pipe 4 is located before the filter 6, the fin of the first fan 8 whose motor and electrical control are not shown and which ensures the circulation of fresh air for the breathing of the newborn 2 in the enclosure 1.
  • This fan has a power of the order of 8 W and it ensures inside the enclosure 1, a circulation of fresh air at constant flow rate of the order of 3 m 3 / h.
  • a sealed double door transfer system 9, of a type known per se, in particular by FR-A-2 040 616 of April 4, 1969, allows rapid introduction and exit into enclosure 1 of all accessories and materials necessary for the patient without breaking the watertightness of the installation.
  • a recycling bypass 10 placed between the inlet 4 and used air outlet 5 pipes, comprises a second fan 11 and a heating element 12 which make it possible to recycle a constant flow of the order of 9 m 3 / h of the atmosphere contained in the enclosure 1 by heating it in contact with the heating fins 13 of the heating element 12.
  • the whole of the insulator described in FIG. 1 is made autonomous from an energy point of view thanks to the conventional storage battery 14 which supplies all the fans 8 and 11 and the heating element 12 to the through a general electrical control 15, certain details of which will be described and shown below with reference to FIG. 3.
  • the assembly is carried on a mobile carriage 16 and can either move independently inside the same hospital for example, or be placed on board a transport ambulance which there is then no need to prepare by disinfecting it beforehand.
  • the walls of the sealed enclosure 1 also include intervention devices forming part of this wall such as gloves 17 and 18; various other useful medical accessories can also be provided on the transport cart 16, such as for example feeding probes and the oxygen cylinder 19 which is used to supply the breathing helmet 20 covering the head of the transported newborn baby 2. All these accessories can be, in a conventional and known manner, handled and used thanks to the double door system 9 and to the handling gloves 17 and 18 without at any time the confinement of the sealed enclosure 1 being broken.
  • the enclosure 1 is preheated by preferably using the sector if there is one available, or the battery 14 otherwise.
  • the fan 11 which, for reasons of simplicity already explained, has only one rotation speed, delivers about 9 m 3 / h for an enclosure 1 of 120 liters of capacity approximately.
  • This flow of 9 m 3 / h results from a choice which results from an optimization to ensure both a minimum transfer of heat energy from the heating element 12 to the enclosure 1 and to avoid at the same time too much air mixing in the enclosure 1 which would lead to too high heat losses.
  • the patient 2 can be introduced through the sealed double door 9 of course. From this moment, it is essential to start the ventilator 8 located on the air duct 4 to propel the fresh respiratory air to the patient 2 (arrows F).
  • the fan 8 also rotates at constant speed and ensures, in the particular case described, an hourly flow rate of approximately 3 m 3 / h.
  • An isolator of the type described in FIG. 1 operates in total autonomy on a battery 14 to which a total power of the order of 100 W is required. This means that it allows long-distance transport (several hundred kilometers) in ambulances or vehicles that do not need to be specialized or prepared in advance. With this type of equipment, a temperature difference of 30 ° C can be obtained if necessary between the temperature of the sealed enclosure 1 and the outside temperature, which is of great interest in countries where winter is very cold, like Canada or the USSR and where until now, such remote transport independently was practically very delicate. Of course, the biological protection of the patient 2 remains during all the transport thanks to the action of the filters 5 and 6.
  • FIG. 2 shows the detail of use of a respiratory helmet 20 on the head of patient 2 when the need arises.
  • two inlet 21 and outlet 22 pipes for respiratory gas pass tightly through the wall 1 of the enclosure and enter the helmet 20 which is simply placed without any seal on the head of the patient 2, who can thus rejecting part of the atmosphere breathed into the internal atmosphere of the enclosure 1.
  • This helmet 20 allows, as already explained previously, both to choose a respiratory atmosphere of particular composition desired and to regulate the humidity of this same atmosphere.
  • FIG. 3 schematically represents the control and the control of the heating of the enclosure 1.
  • the internal temperature sensors 25 and external 26 we see the internal temperature sensors 25 and external 26.
  • the desired set temperature for the interior of the enclosure 1 is displayed on the temperature control 27.
  • the internal temperature 25 is displayed on an external thermometer 28 which in any case allows the doctor supervising the patient to be informed at any time about the value of this temperature.
  • a first adder Si constitutes the temperature error signal between the set temperature displayed at 27 and the external temperature 26. It delivers a first signal which, after passing through the corrector 30, feeds one of the three inputs 31 of the adder S 3 .
  • the corrector 30 has two positions depending on the state of rest or rotation of the fresh air circulation fan 8. When this fan 8 is stopped, the error signal present at 29 is transmitted in the state at 31 to the adder S 3 ; when, on the contrary, the fan 8 is operating at its nominal speed, the signal present at 29 is multiplied before being transmitted on the line 31 by a fixed factor which takes account of the constant cooling introduced into the enclosure 1 by the fresh air flow.
  • the circuit 29, 30, 31 thus carries out the basic control which ensures through the summator S 3 and its output 32 towards the heating element 12 a basic adjustment of this element 12 which makes it possible to approach the temperature prevailing in enclosure 1 of the setpoint displayed at 27.
  • an additional fine control loop makes it possible to complete the adjustment of the heating element 12 as follows: a second error signal constructed from the difference between the indications of the internal sensor 25 and of the temperature control 27 is produced in the summer S 2 and transmitted on line 33 through a corrector network 34 at the input 35 of the summer S 3 . Finally, a thermal safety device 36 consisting of variable thermistors and connected to the heating element 12 transmits on line 37 to the adder S 3 indications concerning a possible exceeding of the admissible limit temperature for the heating element 12 and which most often located in the vicinity of 80 ° C to 120 ° C.
  • control loop will only work for the command of: and the temperature difference between the setpoint and the interior will only be: which leads to internal regulation at the value of: and the temperature difference between the internal temperature and the set temperature has therefore increased from:
  • FIG. 4 one finally shows one of the possible diagrams of embodiment of the heating element 12 in the pipe 10 for recycling air from the sealed enclosure.
  • a certain number of power transistors such as 40, mounted on wafers 41 are provided with their cooling fins 42.
  • Each transistor 40 is supplied across its bias resistance 43.
  • the wafers 41 are mounted two by two face to face, in the pipe 10 of which they constitute a part of the walls and the fins 42, licked by the recycling air which circulates in this pipe 10 serve to dissipate the heat produced by the passage in the transistors 40 of the current determined by the basic control of the servo loop.
  • the transistors 40 can, at certain points, heat up inside to a temperature of the order of 200 ° C., but the corresponding housings do not exceed step 120 ° C, because protective thermistors mounted on transistors 40 prevent the external temperature of these boxes from exceeding 120 ° C as has been explained in connection with the diagram in FIG. 3.
  • the advantage of the embodiment of FIG. 4 resides in the fact that the plates 41 provided with their power transistor 40 and the cooling fins 42 are elements which are found on the market and which adapt on a pipe 100 to constitute the element heating 12 at desired power.
  • the heating element 12 thus perfectly meets all the criteria for dissipation of energy at low temperature and the absence of red dots which can cause fires imposed by the safety of use of installations in accordance with the invention.

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  • Health & Medical Sciences (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pediatric Medicine (AREA)
  • Pregnancy & Childbirth (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Accommodation For Nursing Or Treatment Tables (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)
EP83400485A 1982-03-12 1983-03-09 Isolateur pour le confinement et le transport en atmosphère stérile d'êtres humains, notamment de nouveaux-nés Expired EP0088704B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR8204199A FR2522963A1 (fr) 1982-03-12 1982-03-12 Installation pour le confinement et le transport en atmosphere sterile d'etres humains, notamment de nouveau-nes
FR8204199 1982-03-12

Publications (2)

Publication Number Publication Date
EP0088704A1 EP0088704A1 (fr) 1983-09-14
EP0088704B1 true EP0088704B1 (fr) 1986-02-19

Family

ID=9271924

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Application Number Title Priority Date Filing Date
EP83400485A Expired EP0088704B1 (fr) 1982-03-12 1983-03-09 Isolateur pour le confinement et le transport en atmosphère stérile d'êtres humains, notamment de nouveaux-nés

Country Status (5)

Country Link
US (1) US4509505A (enrdf_load_stackoverflow)
EP (1) EP0088704B1 (enrdf_load_stackoverflow)
CA (1) CA1202220A (enrdf_load_stackoverflow)
DE (1) DE3362140D1 (enrdf_load_stackoverflow)
FR (1) FR2522963A1 (enrdf_load_stackoverflow)

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JP4300863B2 (ja) * 2003-04-25 2009-07-22 澁谷工業株式会社 無菌システムとその使用方法
YU70203A (sh) * 2003-09-05 2006-05-25 Nikola Pavlović Trofunkcionalni neonatalni pokretni inkubator
DE602004026646D1 (de) * 2004-08-18 2010-05-27 Lg Electronics Inc Kontrollverfahren zum automatischen trocknen
WO2010071705A1 (en) * 2008-12-16 2010-06-24 Draeger Medical Systems, Inc. Warming therapy device including dual channel air circulation system
RU2580894C2 (ru) * 2009-07-09 2016-04-10 Конинклейке Филипс Электроникс Н.В. Фототерапевтическое устройство на органических светодиодах
SE534945C2 (sv) * 2010-07-05 2012-02-28 Paer Andersson Med P Andersson Consulting Fa Säkringsanordning för transport av neonatala patienter i en normotempererad kuvös
US10076266B2 (en) 2010-07-07 2018-09-18 Aspect Imaging Ltd. Devices and methods for a neonate incubator, capsule and cart
IL226488A (en) 2013-05-21 2016-07-31 Aspect Imaging Ltd Baby crib
US10499830B2 (en) 2010-07-07 2019-12-10 Aspect Imaging Ltd. Premature neonate life support environmental chamber for use in MRI/NMR devices
US11278461B2 (en) 2010-07-07 2022-03-22 Aspect Imaging Ltd. Devices and methods for a neonate incubator, capsule and cart
CN101947170B (zh) * 2010-09-10 2012-06-20 深圳市宝安区妇幼保健院 一种婴儿温箱及婴儿头部固定装置
US9597246B2 (en) 2010-09-16 2017-03-21 Aspect Imaging Ltd. Premature neonate closed life support system
SG10201802035VA (en) 2013-03-15 2018-04-27 Childrens Hospital Philadelphia Extracorporeal life support system and methods of use thereof
WO2015029046A1 (en) * 2013-09-02 2015-03-05 Aspect Imaging Ltd. An active thermo-regulated neonatal transportable incubator
DE202013104934U1 (de) 2013-11-03 2013-11-20 Aspect Imaging Ltd. Patiententransportinkubator
US10383782B2 (en) 2014-02-17 2019-08-20 Aspect Imaging Ltd. Incubator deployable multi-functional panel
CN105333963A (zh) * 2014-08-11 2016-02-17 夏新月 具有温度报警装置的外置线路隐藏板
JP6766081B2 (ja) 2015-06-19 2020-10-07 ザ・チルドレンズ・ホスピタル・オブ・フィラデルフィアＴｈｅ Ｃｈｉｌｄｒｅｎ’Ｓ Ｈｏｓｐｉｔａｌ Ｏｆ Ｐｈｉｌａｄｅｌｐｈｉａ 早産児の生体外支援のための方法および器具
US11988730B2 (en) 2016-08-08 2024-05-21 Aspect Imaging Ltd. Device, system and method for obtaining a magnetic measurement with permanent magnets
KR20190100241A (ko) 2016-12-14 2019-08-28 더 칠드런스 호스피탈 오브 필라델피아 조산 태아를 위한 체외 지원을 제공하도록 구성된 시스템 및 방법
JP6479090B2 (ja) * 2017-05-10 2019-03-06 アトムメディカル株式会社 保育器
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Also Published As

Publication number Publication date
CA1202220A (en) 1986-03-25
US4509505A (en) 1985-04-09
EP0088704A1 (fr) 1983-09-14
DE3362140D1 (en) 1986-03-27
FR2522963A1 (fr) 1983-09-16
FR2522963B1 (enrdf_load_stackoverflow) 1984-05-25

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