DK174117B1 - Heat and moisture exchanging filters and breathing circuits comprising a filter of this kind and method for making such a filter - Google Patents

Heat and moisture exchanging filters and breathing circuits comprising a filter of this kind and method for making such a filter Download PDF

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DK174117B1
DK174117B1 DK199300701A DK70193A DK174117B1 DK 174117 B1 DK174117 B1 DK 174117B1 DK 199300701 A DK199300701 A DK 199300701A DK 70193 A DK70193 A DK 70193A DK 174117 B1 DK174117 B1 DK 174117B1
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filter
filter according
layer
hydrophilic
hydrophobic
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DK199300701A
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Danish (da)
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DK70193D0 (en
DK70193A (en
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Graham Desmond Lowe
Keith Stuart Morris
Roger Edward Page
Richard Guy Gutman
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Pall Corp
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D46/00Filters or filtering processes specially modified for separating dispersed particles from gases or vapours
    • B01D46/52Particle separators, e.g. dust precipitators, using filters embodying folded corrugated or wound sheet material
    • B01D46/521Particle separators, e.g. dust precipitators, using filters embodying folded corrugated or wound sheet material using folded, pleated material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/1045Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/105Filters
    • A61M16/1055Filters bacterial
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/105Filters
    • A61M16/106Filters in a path
    • A61M16/1065Filters in a path in the expiratory path
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/105Filters
    • A61M16/106Filters in a path
    • A61M16/107Filters in a path in the inspiratory path
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D39/00Filtering material for liquid or gaseous fluids
    • B01D39/14Other self-supporting filtering material ; Other filtering material
    • B01D39/16Other self-supporting filtering material ; Other filtering material of organic material, e.g. synthetic fibres
    • B01D39/18Other self-supporting filtering material ; Other filtering material of organic material, e.g. synthetic fibres the material being cellulose or derivatives thereof
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D39/00Filtering material for liquid or gaseous fluids
    • B01D39/14Other self-supporting filtering material ; Other filtering material
    • B01D39/20Other self-supporting filtering material ; Other filtering material of inorganic material, e.g. asbestos paper, metallic filtering material of non-woven wires
    • B01D39/2068Other inorganic materials, e.g. ceramics
    • B01D39/2082Other inorganic materials, e.g. ceramics the material being filamentary or fibrous
    • B01D39/2089Other inorganic materials, e.g. ceramics the material being filamentary or fibrous otherwise bonded, e.g. by resins
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D46/00Filters or filtering processes specially modified for separating dispersed particles from gases or vapours
    • B01D46/0027Filters or filtering processes specially modified for separating dispersed particles from gases or vapours with additional separating or treating functions
    • B01D46/003Filters or filtering processes specially modified for separating dispersed particles from gases or vapours with additional separating or treating functions including coalescing means for the separation of liquid
    • B01D46/0031Filters or filtering processes specially modified for separating dispersed particles from gases or vapours with additional separating or treating functions including coalescing means for the separation of liquid with collecting, draining means
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D46/00Filters or filtering processes specially modified for separating dispersed particles from gases or vapours
    • B01D46/10Particle separators, e.g. dust precipitators, using filter plates, sheets or pads having plane surfaces
    • B01D46/16Particle separators, e.g. dust precipitators, using filter plates, sheets or pads having plane surfaces arranged on non-filtering conveyors or supports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816Joints or connectors
    • A61M16/0833T- or Y-type connectors, e.g. Y-piece
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2273/00Operation of filters specially adapted for separating dispersed particles from gases or vapours
    • B01D2273/18Testing of filters, filter elements, sealings
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2275/00Filter media structures for filters specially adapted for separating dispersed particles from gases or vapours
    • B01D2275/10Multiple layers

Description

.-1- DK 174117 B1.-1- DK 174117 B1

Opfindelsen vedrører et varme- og fugtighedsvekslende filter af den art, der er angivet i krav l's indledende del.The invention relates to a heat and moisture exchanging filter of the kind set forth in the preamble of claim 1.

5 Mennesker filtrerer den indåndede luft ved hjælp af de nasale hulrum og det øvre respiratoriske system. Desuden indeholder den indåndede luft under de fleste klimaforhold en mængde vanddamp og gennem den indåndede lufts passage til lungerne bliver luften fuldstændigt mættet 10 med fugtighed fra den slim, der udskilles fra slimhindernes slimceller i luftvejene. Ved særlige medicinske fremgangsmåder og f.eks. ved luftforsyning i lukkede rum, såsom en flykabine, kan fugtighedsniveauet i den indåndede luft være mindre end ønskeligt for en tilfredsstillende 15 vejrtrækning.5 Humans filter the inhaled air using the nasal cavities and upper respiratory system. In addition, in most climatic conditions, the inhaled air contains a quantity of water vapor and through the passage of the inhaled air to the lungs, the air becomes completely saturated with moisture from the mucus secreted from the mucous membranes of the airways. In particular medical procedures and e.g. in closed room air supply, such as an aircraft cabin, the humidity level of the inhaled air may be less than desirable for satisfactory breathing.

Eksempelvis forbipasseres ved fremgangsmåder som intubation eller tracheostomering disse øvre luftveje, og der sker således ingen filtrering eller fugtighedsmætning af 20 gasserne, som indåndes fra ventileringsapparaterne, der bruges ved disse fremgangsmåder. De kliniske konsekvenser ved indånding af ufiltreret og fugtighedsumættede gasser er veldokumenterede, se f.eks. "Filtration and Humidification" af Lloyd and Roe, Vol. 4, nr. 4, oktober/december 25 1991 udgaven af publikationen "Problems in RespiratoryFor example, by methods such as intubation or tracheostomation, these upper airways are bypassed, and thus no filtration or moisture saturation of the gases inhaled from the ventilators used in these methods occurs. The clinical consequences of inhalation of unfiltered and moisture-unsaturated gases are well documented, see e.g. "Filtration and Humidification" by Lloyd and Roe, Vol. 4, No. 4, October / December 25 1991 edition of the publication "Problems in Respiratory

Care". Der henvises også til en artikel med titlen "Humidification for Ventilated Patients" af Ballard, Cheese-man, Ripiner and Wells, på s. 2-9, vol. 8 (1992) af publikationen "Intensive and Critical Care Nursing".Care ". Also refer to an article entitled" Humidification for Ventilated Patients "by Ballard, Cheese-man, Ripiner and Wells, at pp. 2-9, vol. 8 (1992) of the publication" Intensive and Critical Care Nursing ". .

3030

For at imødegå dette, problem, er det almindeligt: at indbygge en indretning, der både filtrerer den udåndede luft samt varmer og befugter den indåndede gas i ventileringsapparaturet. Sådanne indretninger er beskrevet i de -2- DK 174117 B1 . to ovennævnte publikationer og i artiklen "A Comparison of the Filtration Properties of Heat and Moisture Exchangers" af Hedley and Allt-Graham i publikationen "Anaesthesia 192, vol. 47, s. 414-420, og i artiklen "An 5 Alternative Strategy for Infection Control of Anesthesia Breathing Circuits: A Laboratory Assessment of the Pall HME Filter" af Berry and Nolte, s. 651-655, i publikationen "Anesth.Analg.", 1991, 72.To counter this, problem, it is common: to incorporate a device that filters both the exhaled air and heats and humidifies the inhaled gas in the ventilation apparatus. Such devices are described in the -2- 174177 B1. two above publications and in the article "A Comparison of the Filtration Properties of Heat and Moisture Exchangers" by Hedley and Allt-Graham in the publication "Anaesthesia 192, vol. 47, pp. 414-420, and in the article" An 5 Alternative Strategy for Infection Control of Anesthesia Breathing Circuits: A Laboratory Assessment of the Pall HME Filter "by Berry and Nolte, pp. 651-655, in the publication" AnesthesiaAnalg. ", 1991, 72.

10 Lloyd og Roe publikationen beskriver tre kategorier af varme- og fugtighedsvekslende filtre. Den første kategori kaldes "hygroskopiske (første generations)" varme- og fugtighedsvekslende filtre. Disse filtre indeholder uld, skum eller papirlignende materiale, der sædvanligvis er 15 imprægneret med hygroskopiske kemikalier som f.eks. lithiumchlorid eller calciumchlorid til absorption af kemiske vanddampmolekyler, der findes i den udåndede luft.10 The Lloyd and Roe publication describes three categories of heat and moisture alternating filters. The first category is called "hygroscopic (first generation)" heat and moisture alternating filters. These filters contain wool, foam or paper-like material which is usually impregnated with hygroscopic chemicals such as e.g. lithium chloride or calcium chloride for the absorption of chemical water vapor molecules found in the exhaled air.

Den anden kategori kaldes "hygroskopiske (anden generations)" varme- og fugtighedsvekslende filtre. Disse filtre 20 er de samme som første-generationsfiltrene, men omfatter derudover filtermateriale af elektretfilt. Elektreter er materialer, der opretholder en permanent elektrisk polaritet og danner et elektrisk felt omkring materialerne uden at danne et ydre elektrisk felt. Sådanne materialer 25 fjerner mikroorganismer ved elektrostatisk påvirkning. Et eksempel på dette er vist i EP-A1-0011847.The second category is called "hygroscopic (second generation)" heat and moisture alternating filters. These filters 20 are the same as the first generation filters, but additionally include electret felt filter material. Electrets are materials that maintain a permanent electrical polarity and form an electric field around the materials without forming an outer electric field. Such materials remove microorganisms by electrostatic action. An example of this is shown in EP-A1-0011847.

EP-A2-0265163 omhandler brugen af et lag hydrofobt filtermateriale og et lag hydrofilt skum i et hus. Lagene er 30 dannet af ikke-forbundne flade lag, der indbyrdes er i kontakt med hinanden. Det hydrofobe lag er fremstillet af polypropylenfibre, der er elektrostatisk opladet til udførelse af virus- og bakteriefiltrering og fungerer såle- -3- DK 174117 B1 des som et elektret, således som ved den anden kategori af de ovenfor beskrevne filtre. Skumlaget er indrettet til at absorbere fugtighed. Skumlaget fungerer svarende til anordningen, der kendes fra EP-A1-0011847 og med de 5 deraf følgende ulemper.EP-A2-0265163 discloses the use of a layer of hydrophobic filter material and a layer of hydrophilic foam in a housing. The layers are formed of unconnected flat layers which are in contact with each other. The hydrophobic layer is made of polypropylene fibers that are electrostatically charged to perform virus and bacterial filtration and thus function as an electret, as in the second category of the filters described above. The foam layer is adapted to absorb moisture. The foam layer functions similar to the device known from EP-A1-0011847 and with the 5 disadvantages thereof.

Den tredje kategori af filtre omfatter brugen af en hydrofob membran, der fjerner mikroorganismer ved ren filtrering og tilbageholder fugtighed på overfladen af mem-10 branen som følge af hydrofobiciteten.The third category of filters includes the use of a hydrophobic membrane which removes microorganisms by pure filtration and retains moisture on the surface of the membrane due to the hydrophobicity.

Alle tre filterkategorier fungerer på i alt væsentligt samme måde. Ved udånding kondenseres den udåndede vanddamp på filteret, og ved indånding opsamler de indåndede 15 gasser vanddamp (og varme) fra indretningen ved fordampning. Mikroorganismer såsom bakterier og vira fjernes fra den udåndede og indåndede luft ved hjælp af filtre i deres respektive strømningskanaler.All three filter categories operate in essentially the same way. Upon exhaling, the exhaled water vapor condenses on the filter, and upon inhalation, the inhaled 15 gases collect water vapor (and heat) from the device by evaporation. Microorganisms such as bacteria and viruses are removed from the exhaled and inhaled air by means of filters in their respective flow channels.

20 Den første kategori af filtre finder kun ringe anvendelse i dag. Disse filtre har lav effektivitet til fjernelse af bakterier, der findes i luften, selv når filtrene er imprægnerede med bakteriedræbende midler. Ydermere opnår filtrene ikke omgående maksimal varme- og fugtighedsveks-25 lingseffektivitet som følge af deres virkemåde, og de har en relativt lang akklimatiseringsperiode, før de fungerer ensartet og stabilt. Filtrene har tilmed relativt store porer og en relativt stor tykkelse, hvilket muliggør, at væske strømmer ind i porerne og passerer gennem materia-30 let, hvilket medfører en vandmættet tilstand og en deraf følgende forøget strømningsmodstand.20 The first category of filters is of little use today. These filters have low efficiency in removing bacteria found in the air, even when the filters are impregnated with bactericidal agents. Furthermore, the filters do not immediately achieve maximum heat and humidity exchange efficiency due to their operation and have a relatively long acclimation period before operating uniformly and stably. The filters also have relatively large pores and a relatively large thickness, which allows liquid to flow into the pores and pass through the material, resulting in a water-saturated state and consequent increased flow resistance.

-4- DK 174117 B1-4- DK 174117 B1

Den anden kategori af filtre har forbedret mikroorganis-mefiltrering sammenlignet med den første generation af hygroskopiske filtre. Imidlertid er forurenede væsker, der passerer gennem lagene på grund af de relativt store 5 porer, stadig et problem. Desuden kan filtereffektivite-terne, som beskrevet i Lloyd og Roe referencen, ikke nå op på 99,9977%, der er foreslået som minimumfjernelsesniveau for filtre, der skal være egnede til klinisk brug.The second category of filters has improved microorganism filtering compared to the first generation of hygroscopic filters. However, contaminated liquids passing through the layers due to the relatively large 5 pores are still a problem. In addition, as described in the Lloyd and Roe reference, the filter efficiencies cannot reach 99.9977%, proposed as the minimum removal level for filters that should be suitable for clinical use.

10 Den tredje kategori af filtre, hvor der benyttes hydrofobe membraner, har særligt små porer, typisk med et alko-holboblepunkt, der er større end 710 mm (28") H^O. Boblepunktet er målt i overensstemmelse med forskrifterne fra American Society of Testing Materials. Disse membraner 15 forhindrer passage af forurenede væsker ved sædvanlige ventilationstryk. Disse filtre fungerer også som en barriere for mikroorganismer, der findes i vandet, og muliggør en effektivitet på mere end 99.9977%. 1 mange tilfælde har hydrofobe membranfiltre vist sig at kunne tilveje-20 bringe en varme- og fugtveksling, der kan sammenlignes med en normal nasal vejrtrækning. En optimal befugtnings-effektivitet opnås næsten omgående.The third category of filters employing hydrophobic membranes has particularly small pores, typically with an alcohol bubble greater than 710 mm (28 ") H 2 O. The bubble point is measured in accordance with the regulations of the American Society of Testing Materials These membranes 15 prevent the passage of contaminated liquids at usual ventilation pressures, which also act as a barrier to microorganisms found in the water, and provide an efficiency of more than 99.9977 %.1 In many cases, hydrophobic membrane filters have been shown to be capable of provide a heat and moisture exchange comparable to a normal nasal breathing, an optimal wetting efficiency is achieved almost immediately.

Udåndingsluft indeholder vand, ikke bare i form af 25 vanddråber og -perler, men også i form af vanddamp. Det er muligt for denne vanddamp at passere gennem filteret og forsvinde i systemet. Det betyder, at ved indånding er ikke alt udåndet vand tilgængelig for befugtning. Dette er sædvanligvis ikke noget problem. Imidlertid kan som 30 omtalt i den tekniske rapport "Use of the Pall Heat and Moisture Exchange Filter (HMEF) with Cold Humidification" af Belkowski and Brandwein fra Pali Corporation, publiceret i 1992 som Pall Technical Publication PCC19210M, et -5- DK 174117 B1 lille antal langtidspatienter med åndedrætslidelser behøve større befugtning af indåndingsluften, end et varme-og fugtvekslingsfilter af den tredie kategori kan tilvejebringe. I den tekniske rapport anføres, at dette pro-5 biem kan løses ved at inkorporere en befugtningsindret-ning i åndedrætskredsløbet. I et alternativt forsøg på at løse dette problem er det hydrofobe materiale kombineret med en hygroskopisk materiale af den type, der benyttes i den første og anden kategori for at absorbere vand.Exhaled air contains water, not only in the form of 25 drops and beads, but also in the form of water vapor. It is possible for this water vapor to pass through the filter and disappear into the system. This means that when inhaled, not all exhaled water is available for wetting. This is usually no problem. However, as mentioned in the technical report "Use of the Pall Heat and Moisture Exchange Filter (HMEF) with Cold Humidification" by Belkowski and Brandwein of Pali Corporation, published in 1992 as Pall Technical Publication PCC19210M, a -5- DK 174117 B1 A small number of long-term patients with respiratory disorders need greater humidification of the inhalation air than a third-category heat and moisture exchange filter can provide. The technical report states that this problem can be solved by incorporating a humidifier into the respiratory circuit. In an alternative attempt to solve this problem, the hydrophobic material is combined with a hygroscopic material of the type used in the first and second categories to absorb water.

10 I GB-A-2167307 er beskrevet et varme- og fugtvekslingsfilter omfattende alternerende hydrofobe og hydrofile skiver, der er anbragt i et hus, idet de hydrofile skiver er imprægneret med et hygroskopisk materiale. Disse filt-15 re har tendens til at blive mættet med vand.GB-A-2167307 discloses a heat and moisture exchange filter comprising alternating hydrophobic and hydrophilic discs housed in a housing, the hydrophilic discs being impregnated with a hygroscopic material. These filters tend to be saturated with water.

Formålet med opfindelsen er at angive et varme- og fug-tighedsudvekslende filter, som har høj fjernelseseffektivitet for mikroorganismer kombineret med et forholdsvis 20 lille varmetab.The object of the invention is to provide a heat and moisture exchange filter which has high removal efficiency for microorganisms combined with a relatively small heat loss.

Formålet opnås ved et varme- og fugtvekslende filter omfattende et hus med en første del for tilslutning til en forsyning af indåndingsgas og et udåndingsrør samt en an-25 den del for tilslutning til en person, der ind- og udånder gassen, hvor huset indeholder et lag hydrofilt filtermateriale og et lag hydrofobt filtermateriale anbragt i serie i en strømningsvej mellem den første og den anden del, hvor det hydrofile materiale er nærmest den første 30 del i strømningsvejen, hvilket filter er ejendommeligt ved, at det hydrofobe materiale har et alkoholboblepunkt højere end 710 mm (28") H20 til fjernelse af mikroorganismer .The object is achieved by a heat and moisture exchanging filter comprising a housing with a first part for connecting to a supply of inhalation gas and an exhalation tube, and a second part for connecting to a person breathing and exhaling the gas, the housing containing a a layer of hydrophilic filter material and a layer of hydrophobic filter material arranged in series in a flow path between the first and second portions, where the hydrophilic material is closest to the first portion of the flow path, which filter is characterized in that the hydrophobic material has an alcohol bubble higher than 710 mm (28 ") H2 O to remove microorganisms.

-6- DK 174117 B1 I alle tre filterkategorier er det af afgørende betydning, at filtermaterialet ikke bevirker et betydeligt tryktab, således af indåndingen og udåndingen vanskelig-5 gøres. Dette er sædvanligvis ikke noget problem med filtre fra den første og anden kategori, da porestørrelsen i filtermaterialet er tilstrækkelig til, at der ikke sker et problematisk tryktab. Filtrene fra den tredie kategori kan imidlertid være behæftet med denne ulempe.-6- DK 174117 B1 In all three categories of filters, it is essential that the filter material does not cause a significant loss of pressure, thus making inhalation and exhalation difficult. This is usually not a problem with filters from the first and second categories, as the pore size of the filter material is sufficient to prevent a problematic pressure loss. However, the filters of the third category may suffer from this disadvantage.

1010

Filtermaterialelagene er fortrinsvis foldede. Dette giver et større materialeareal og reducerer dermed tryktabet.The filter material layers are preferably folded. This gives a larger material area and thus reduces the pressure loss.

Opfindelsen angår desuden en fremgangsmåde til fremstil-15 ling af et varme- og fugtighedsvekslende filter omfattende anvendelse af et lag hydrofobt materiale med to indbyrdes modstående yderflader og et lag hydrofilt materiale med to indbyrdes modstående yderflader, hvilken fremgangsmåde er ejendommelig ved, at laget af hydrofobt ma-20 teriale har et alkoholboblepunkt, der er større end 710 mm (28") H:0, og ved at en yderflade af det hydrofobe materiale forbindes med en yderflade af det hydrofile materiale.The invention further relates to a method for producing a heat and moisture exchange filter comprising the use of a layer of hydrophobic material having two mutually opposite outer faces and a layer of hydrophilic material having two mutually opposite outer faces, the process being characterized in that the layer of hydrophobic material has an alcohol bubble point greater than 710 mm (28 ") H: 0 and by connecting an outer surface of the hydrophobic material to an outer surface of the hydrophilic material.

25 I den følgende detaljerede beskrivelse beskrives som eksempler nogle udførelsesformer for opfindelsen med henvisning til den medfølgende tegning, hvor fig. 1 skematisk viser et varme- og fugtighedsvekslende 30 filter dannet af foldet filtermateriale og set fra den ene ende, -7- DK 174117 B1 fig. 2 skematisk viser en første konfiguration af et hydrofilt materiale i filteret vist på fig. 1, fig. 3 skematisk viser en anden konfiguration af et hy-5 drofilt materiale i filteret vist på fig. 1, fig. 4 skematisk viser en patientattrap til brug ved afprøvning af effektiviteten ved det varme- og fugtigheds-vekslende filter, 10 fig. 5 viser den på fig. 4 afbildede patientattrap forbundet til en ventilator i en første konfiguration til kalibrering før test, 15 fig. 6 viser den på fig. 4 afbildede patientattrap forbundet til en ventilator i en anden konfiguration til test af varme- og fugtighedsvekslingseffektiviteten, og hvor 20 fig. 7 skematisk viser et diagram af udstyr, der benyttes ; til bestemmelse af et filters effektivitet ved en aerosolsammenligningstest .In the following detailed description, exemplary embodiments of the invention are described with reference to the accompanying drawings, in which: FIG. 1 schematically shows a heat and moisture-exchanging filter formed of folded filter material and seen from one end; FIG. 2 schematically shows a first configuration of a hydrophilic material in the filter shown in FIG. 1, FIG. 3 schematically shows another configuration of a hydrophilic material in the filter shown in FIG. 1, FIG. Figure 4 shows schematically a patient trap for use in testing the efficiency of the heat and humidity-changing filter; 5 shows the one shown in FIG. 4 depicts patient dummy connected to a fan in a first configuration for pre-test calibration; FIG. 6 shows that in FIG. 4 depicts patient traps connected to a fan in a different configuration for testing the heat and moisture exchange efficiency, and wherein FIG. 7 schematically shows a diagram of equipment used; for determining the efficiency of a filter in an aerosol comparison test.

Som det fremgår af fig. 1, omfatter filteret et lag hy-25 drofobt materiale 10 foldet sammen med et hydrofilt materiale 11. De to lag kan være adskilt eller indbyrdes forbundne ved laminering eller ved sammenkobling ved hjælp af en hvilken som helst passende fremgangsmåde. Filtermaterialet er indkapslet i et hus 12 med to åbninger 13,14, 30 der respektivt fører til modstående sider af filtermaterialet. Som det fremgår af fig. 1 og 6, udfylder det foldede filtermateriale huset 12 således, at folderne på én side af filtermaterialet er tæt beliggende ved den ene -8- DK 174117 B1 åbning 13, og folderne ved den anden side filtermaterialet er tæt beliggende ved den anden åbning 14.As shown in FIG. 1, the filter comprises a layer of hydrophobic material 10 folded together with a hydrophilic material 11. The two layers may be separated or interconnected by lamination or by coupling by any suitable method. The filter material is encased in a housing 12 with two openings 13, 14, 30 respectively leading to opposite sides of the filter material. As shown in FIG. 1 and 6, the folded filter material fills the housing 12 such that the folds on one side of the filter material are closely located at one opening 13, and the folds at the other side the filter material are closely located at the other opening 14.

Det hydrofobe materiale 10 er fortrinsvis keramiske fib-5 re, der er sammenlimet ved hjælp af harpiks, og som fjerner mikroorganismer ved direkte mekanisk påvirkning og således har et alkoholvædet boblepunkt på over 710 mm(28") H^O. Dette er målt ved hjælp af den fremgangsmåde til en sådan test, som angives af American Society of 10 Testing Materials. Det hydrofile materiale er fortrinsvis et cellulosemateriale. Materialet skal være af en ikke-partikel udskillende art.The hydrophobic material 10 is preferably ceramic fibers which are bonded together by resin and which remove microorganisms by direct mechanical action and thus have an alcohol wetted bubble point of over 710 mm (28 ") H 2 O. The hydrophilic material is preferably a cellulose material, the material being of a non-particulate separating nature.

Filteret har fortrinsvis et tryktab, der ikke er større 15 end 3,0 cm H;0 ved en luftgennemstrømning på 60 1/min og en aerosol-bakteriefjernelseseffektivitet på over 99,999% målt ved en aerosolsammenligningstest, som beskrives i det følgende.The filter preferably has a pressure drop not greater than 3.0 cm H 0 at an air flow rate of 60 l / min and an aerosol bacterial removal efficiency greater than 99.999% as measured by an aerosol comparison test described below.

20 Det hydrofile materiale kan, som det fremgår af fig. 2, være et kontinuert materialestykke. Som det fremgår af fig. 3, kan materialet imidlertid også være udformet diskontinuert med et antal rækker gennemgående parallelle slidser i indbyrdes afstand fra hinanden. Slidserne sik-25 rer ved deres tilstedeværelse, at det maksimale tryktab over indretningen kontrolleres af det hydrofobe materiale. Slidserne tillader strømning gennem det hydrofile materiale i tilfælde af, at dette skulle blive gennemvædet (f.eks. blive mættet med vand).The hydrophilic material can, as can be seen from FIG. 2, be a continuous piece of material. As shown in FIG. 3, however, the material may also be formed discontinuously with a plurality of rows of parallel slots spaced apart. The slots ensure, in their presence, that the maximum pressure drop across the device is controlled by the hydrophobic material. The slots allow flow through the hydrophilic material in the event that it should be soaked (for example, being saturated with water).

Indretningen bruges ved patient-enden af et åbent vejrtrækningssystem der i hovedsagen bruges intensive behandlingsenheder. Sådanne systemer bruges af patienter, der 30 -9- DK 174117 B1 har behov for ventilation gennem længere tid, og af patienter, som på grund af deres kliniske tilstand af systemet kræver ekstra befugtning under ventilering.The device is used at the patient end of an open breathing system which is used in the main intensive care units. Such systems are used by patients who require long-term ventilation and by patients who, due to their clinical state of the system, require additional wetting during ventilation.

5 Sådanne systemer omfatter en ventilator, et rør til forbindelse af ventilatoren til en åbning på indretningen ved den side, hvor det hydrofile materiale 11 befinder sig, og et rør, der forbinder den anden åbning på siden, hvor det hydrofobe materiale befinder sig, til patienten, 10 som ind- og udånder gas fra ventilatoren. Derudover forefindes et ventilsystem, som tillader udåndingsluften at undvige gennem en udåndingsåbning efter passage gennem indretningen.Such systems include a fan, a tube for connecting the fan to an opening on the device at the side where the hydrophilic material 11 is located, and a tube connecting the second opening on the side where the hydrophobic material is located. the patient, 10 which inhales and exhales gas from the ventilator. In addition, there is a valve system which allows the exhaled air to evade through an exhalation opening after passage through the device.

15 Ved brug bliver det hydrofobe materiale 10 ikke gennemvædet med væske fra patienten og giver lav luftstrømningsmodstand samt en høj effektivitet ved fjernelse af mikroorganismer ved mekanisk opsamling.In use, the hydrophobic material 10 is not soaked with fluid from the patient and provides low air flow resistance as well as a high efficiency of removal of microorganisms by mechanical collection.

20 Det hydrofile materiale 11 fungerer på følgende måde.The hydrophilic material 11 functions as follows.

Vand, der passerer gennem det hydrofobe materiale i hovedsagen i form af vanddamp opfanges af det hydrofile materiale på grund af dettes hydrofile egenskaber. Opfanget fugt spredes derpå over hele det hydrofile materiale 11's 25 areal. På denne måde passerer indåndingsgasserne først gennem det hydrofile materiale 11, hvor de opsamler denne fugt, før gasserne på normal vis optager yderligere fugt fra det hydrofobe materiale. Det har den fordel, at der ikke er behov for en yderligere befugter ved forøgelse af 30 befugtningsniveauet.Water passing through the hydrophobic material, mainly in the form of water vapor, is captured by the hydrophilic material due to its hydrophilic properties. Trapped moisture is then spread over the entire area of the hydrophilic material 11. In this way, the inhalation gases first pass through the hydrophilic material 11, where they collect this moisture, before the gases normally absorb additional moisture from the hydrophobic material. It has the advantage that no additional humidifier is needed to increase the wetting level.

Derudover overvindes et yderligere problem ved hjælp af det hydrofobe materiale. Problemet består i, at der kan -10- DK 174117 B1 vasre områder af materialet, som ikke dækkes af vand, idet vand ikke vil spredes jævnt over et hydrofobt materiale.In addition, a further problem is overcome by the hydrophobic material. The problem is that there can be areas of the material that are not covered by water, since water will not spread evenly over a hydrophobic material.

Derved skabes foretrukne passager for indåndingsgasser gennem det hydrofobe materiale, hvor der kun finder en 5 ringe eller slet ingen befugtning sted. Når fugt spredes jævnt gennem det hydrofile materiale, undgås dette problem.Thereby, preferred passages for inhalation gases are created through the hydrophobic material, where only a little or no wetting takes place. When moisture is evenly spread through the hydrophilic material, this problem is avoided.

Muligheden for blokering af filteret ved gennemvædning af 10 det hydrofile materiale, dvs. at det hydrofile materiale bliver mættet med vand, undgås ved at vælge et cellulosemateriale med en passende porestørrelse og -tykkelse, således at det har et boblepunkt, der er tilstrækkeligt lavt til at tillade fjernelse af overskydende vand ved 15 gasgennemstrømning. Eksempelvis findes et cellulosemateriale fra Pali Corporation, der har et alkoholboblepunkt på mellem 64 mm og 114 mm (2,5" til 4,5") H20. Dette er målt efter fremgangsmåden, der angives af American Institute of Testing Materials.The possibility of blocking the filter by soaking the hydrophilic material, ie. that the hydrophilic material becomes saturated with water is avoided by selecting a cellulose material of an appropriate pore size and thickness such that it has a bubble point sufficiently low to permit the removal of excess water at gas flow. For example, there is a cellulose material from Pali Corporation which has an alcohol bubble of between 64 mm and 114 mm (2.5 "to 4.5") H2 O. This is measured according to the method set by the American Institute of Testing Materials.

2020

En sammenkobling af lagene, hvor dette er hensigtsmæssigt, gør det lettere at folde lagene, uden at danne mellemrum, hvori der kan opsamles vand. Derudover er sammenkoblingen fordelagtig til formindskelse eller undgåelse 25 af gennemvædning af det hydrofile materiale 11's befugtning.An interconnection of the layers, where appropriate, makes it easier to fold the layers without creating spaces in which water can be collected. In addition, the coupling is advantageous for reducing or avoiding soaking of the wetting of the hydrophilic material 11.

Den kendsgerning, at materialet 10,11 udfylder huset 12, minimerer de døde rum i huset 12. Dette er fordelagtigt, 30 idet volumenet af genindåndet gas herved minimeres.The fact that the material 10, 11 fills the housing 12 minimizes the dead space in the housing 12. This is advantageous, since the volume of the inhaled gas is thereby minimized.

I det følgende beskrives tests af en indretning af den ovenfor angivne art med henvisning til tegningerne og i - ii - DK 174117 B1 sammenligning med to kommercielt tilgængelige filtre af den anden kategori, som er angivet i indledningen til denne beskrivelse {benævnt 2A henholdsvis 2B i nedenstående tabel 1), to filtre af den tredie kategori som angi-5 vet i indledningen til denne beskrivelse (benævnt 3A henholdsvis 3B i nedenstående tabel 1) samt to filtre af den tredie kategori, som er tilføjet et hygroskopisk materiale for tilbageholdelse af fugtighed (benævnt M3A henholdsvis M3B i nedenstående tabel 1).In the following, tests of a device of the kind described above are described with reference to the drawings, and - ii - DK 174117 B1 comparison with two commercially available filters of the second category given in the preamble to this specification {referred to as 2A and 2B respectively. Table 1 below), two filters of the third category indicated in the introduction to this description (referred to as 3A and 3B of Table 1 below, respectively) and two filters of the third category, which have added a hygroscopic moisture retention material ( referred to as M3A and M3B respectively in Table 1 below.

1010

Det som eksempel beskrevne filter ifølge opfindelsen blev udformet som angivet ovenfor med et areal på ca. 640 til 650 cm2.The example described filter according to the invention was designed as indicated above with an area of approx. 640 to 650 cm2.

15 Det hydrofobe materiale i det som eksempel beskrevne filter ifølge opfindelsen blev fremstillet af forud blandede keramiske fibre sammenlimet med en egnet, destabiliseret harpiks og havde et alkoholboblepunkt på mere end 710 mm (28") H^O målt som beskrevet ovenfor. Mængden af harpiks 20 var 10% i forhold til fibrene (vægt/vægt). De sammenlimede fibre blev derefter gjort hydrofobe ved hjælp af en kendt fremgangsmåde.The hydrophobic material in the exemplary filter according to the invention was made from premixed ceramic fibers glued together with a suitable, destabilized resin and had an alcohol bubble of more than 710 mm (28 ") H 2 O as measured above. 20 was 10% relative to the fibers (w / w) The glued fibers were then made hydrophobic by a known method.

Det som eksempel beskrevne filters hydrofile filtermate-25 riale ifølge opfindelsen blev fremstillet af cellulosefiltre sammenlimet med et bindemiddel og med følgende sammensætning og egenskaber:The hydrophilic filter material of the invention described by way of example is made of cellulose filters bonded to a binder and having the following composition and properties:

Fibre: 100% hampFiber: 100% hemp

Bindemiddel: ViskoseBinder: Viscose

Tryktab: 74 (mm vandsøjle) (2,9" vandsøjle)Pressure Loss: 74 (mm water column) (2.9 "water column)

Trækstyrke: 92-115 (kg/mm) (8-10 Ibs/in)Tensile strength: 92-115 (kg / mm) (8-10 lbs / in)

Tykkelse: 0,081 mm (3,2" x 10~3) - 12- DK 174117 B1Thickness: 0.081 mm (3.2 "x 10 ~ 3) - 12- DK 174117 B1

Trækstyrke: 103 kg/itun (8,9 Ib/in) fugtet med olieTensile strength: 103 kg / itun (8.9 lb / in) moistened with oil

Trækstyrke: 44 kg/mm (3,8 lbs/in) fugtet med vandTensile strength: 44 kg / mm (3.8 lbs / in) moistened with water

Brudstyrke: 3520-4400 kg/mm2 (12-15 lb/in2)Breakage strength: 3520-4400 kg / mm2 (12-15 lb / in2)

Alle filtrene blev undersøgt for vandtab, bakteriefjernelseseffektivitet og virusfjernelseseffektivitet under anvendelse af de nedenfor beskrevne undersøgelsesmetoder.All filters were tested for water loss, bacterial removal efficiency and virus removal efficiency using the study methods described below.

55

UNDERSØGELSE AF VANDTABINVESTIGATION OF WATER LOSS

Denne undersøgelse beskrives med henvisning til fig. 4-6.This study is described with reference to FIG. 4-6.

10 Den på fig. 4 viste patientattrap omfatter en befugter 20, der kan levere udåndet luft med et forudbestemt fugtindhold og en forudbestemt temperatur. En første åbning 21 på befugteren forbindes til en gummilunge 22 med en kapacitet på 2 liter og til et forbindelsesrør 23 gennem 15 en styreventil, der forhindrer strømning fra åbningen 21 til forbindelsesrøret 23 og tillader strømning i modsat retning.10 The embodiment of FIG. 4 includes a humidifier 20 capable of delivering exhaled air with a predetermined moisture content and a predetermined temperature. A first opening 21 of the humidifier is connected to a rubber tube 22 having a capacity of 2 liters and to a connecting tube 23 through 15 a control valve which prevents flow from the opening 21 to the connecting tube 23 and allows flow in the opposite direction.

Befugteren 20's anden åbning 25 er forbundet til et T-20 formet forbindelsesstykke 26 gennem en styreventil 27 og tillader strømning fra den anden åbning 25 til den T-formede konnektor 26 og forhindrer strømning i den modsatte retning. Det T-formede forbindelsesstykke 26 er forbundet til den anden ende af forbindelsesrøret 23 via 25 en tredie styreventil 28, der tillader strømning fra det T-formede forbindelsesstykke 26 til forbindelsesrøret 12, men forhindrer strømning i den modsatte retning.The second opening 25 of the humidifier 20 is connected to a T-20 shaped connector 26 through a control valve 27 and permits flow from the second opening 25 to the T-shaped connector 26 and prevents flow in the opposite direction. The T-shaped connector 26 is connected to the other end of the connector 23 via 25 a third control valve 28 which allows flow from the T-shaped connector 26 to the connector 12, but prevents flow in the opposite direction.

-13- DK 174117 B1-13- DK 174117 B1

Befugteren 20 omfatter en temperaturkontrolindretning 29, der styrer temperaturen af den luft, der afgives fra be-fugteren 20.The humidifier 20 comprises a temperature control device 29 which controls the temperature of the air emitted from the humidifier 20.

5 Ved brug påfyldes befugteren 20 destilleret vand. Som det fremgår af fig. 5, skal udgangen 30 på det T-formede forbindelsesstykke 26 derefter forbindes til stammen 31 på et Y-formet forbindelsesstykke 32. En gren 33 på det Y-formede forbindelsesstykke forbindes via et rør 34 til en 10 indgangsåbning på en ventilator 35, og den anden gren 36 på det Y-formede forbindelsesstykke 32 forbindes via et rør 37 til udgangen på ventilatoren 35.5 In use, the humidifier 20 is filled with distilled water. As shown in FIG. 5, the output 30 of the T-shaped connector 26 must then be connected to the stem 31 of a Y-shaped connector 32. A branch 33 of the Y-shaped connector is connected via a tube 34 to an inlet opening of a fan 35, and the the second branch 36 of the Y-shaped connector 32 is connected via a pipe 37 to the outlet of the fan 35.

Ventilatoren leverer gasser, der kan indåndes, i pulser, 15 hvis volumen og frekvens kontrolleres. Det i en puls leverede volumen betegnes "respirationsvolumen", og frekvensen måles i "åndedrag/minut".The fan delivers inhalable gases in pulses whose volume and frequency are controlled. The volume delivered in a pulse is called "respiratory volume" and the frequency is measured in "breath / minute".

Ved undersøgelse af varme- og fugtighedsvekslingseffekti-20 viteten indstilles ventilatoren 35’s respirationsvolumen til en kendt værdi, f.eks. 660 ml, og frekvensen til en kendt værdi, f.eks. 15 åndedrag/minut. Hvert volumen luft, der afgives fra ventilatoren 35, strømmer i røret 37 til det T-formede forbindelsesstykke 26. Styret af 25 styreventilerne 24,27,28 passerer denne gas rundt via forbindelsesrøret 23 og ind i gummilungen 22, der udvides til optagelse af luften. Når luftpulsen slutter, udånder gummilungen 22 luft, der styret af styreventilen passerer gennem befugteren 20 og bortledes gennem den anden åbning 30 25 og det T-formede forbindelsesstykke 26 for at vende tilbage til ventilatoren 35Ts indgang gennem røret 34.Upon examination of the heat and humidity exchange efficiency, the ventilation volume of the fan 35 is set to a known value, e.g. 660 ml, and the frequency to a known value, e.g. 15 breaths / minute. Each volume of air emitted from the fan 35 flows into the tube 37 to the T-shaped connector 26. The control of the 25 control valves 24,27,28 passes this gas through the connecting tube 23 and into the rubber tube 22 which is expanded to receive the air. . When the air pulse ends, the rubber tube 22 exhales air controlled by the control valve through the humidifier 20 and is discharged through the second opening 30 25 and the T-shaped connector 26 to return to the inlet of the fan 35T through the tube 34.

-14- DK 174117 B1-14- DK 174117 B1

Det T-formede forbindelsesstykke 26 er isoleret for at forhindre kondens.The T-shaped connector 26 is insulated to prevent condensation.

Systemet arbejder i 30 minutter for at tillade det at 5 varme op med den for patientattrappen fastsatte temperatur på 30 °C eller 34 °C. Efter 30 minutter afbrydes ventilatoren 35 og patientattrappens temperaturkontrolindretning 29.The system works for 30 minutes to allow it to warm up with the temperature set for the patient dummy at 30 ° C or 34 ° C. After 30 minutes, the fan 35 and the patient dummy temperature control device 29 are switched off.

10 Derefter fjernes røret 34 fra den første gren 33 på det Y-formede forbindelsesstykke 32 og erstattes af et rør med et dertil forbundet hus 38 indeholdende 100 g tørremiddel. Huset 38 forbindes således til den første gren 33 på det Y-formede forbindelsesstykke 32 og til indgangsåb-15 ningen på ventilatoren 35.Then the tube 34 is removed from the first branch 33 of the Y-shaped connector 32 and replaced by a tube with an associated housing 38 containing 100 g of desiccant. The housing 38 is thus connected to the first branch 33 of the Y-shaped connector 32 and to the inlet opening of the fan 35.

Desuden monteres det varme- og fugtighedsvekslende filter 39, der skal undersøges, i røret mellem udgangsåbningen 30 og stammen 31 på det Y-formede forbindelsesstykke 32.In addition, the heat and moisture exchanging filter 39 to be examined is mounted in the tube between the outlet opening 30 and the stem 31 on the Y-shaped connector 32.

2020

Derpå vejes patientattrappen, og komponenterne mellem det T-formede forbindelsesstykke 26 og ventilatoren vejes. Vejningen omfatter huset 38 og dets indhold samt filteret 39. Vægtene angives med én decimal.The patient dummy is then weighed and the components between the T-shaped connector 26 and the fan are weighed. The weighing comprises the housing 38 and its contents as well as the filter 39. The weights are indicated by one decimal place.

2525

Ventilatoren 35 og patientattrappen aktiveres igen i én time. Hvis omgivelsestemperaturen under denne periode ikke reguleres, måles udåndingsluftens temperatur (dvs. temperaturen i røret 37) med regelmæssige mellemrum. Den 30 bør være ca. 20 °C og bør ikke overstige 23 °C. Hvis temperaturen overstiger 23 °C, bør der anbringes is eller afkølet vand omkring røret for at reducere temperaturen.The fan 35 and the patient dummy are reactivated for one hour. If the ambient temperature is not controlled during this period, the temperature of the exhalation air (ie the temperature of the tube 37) is measured at regular intervals. The 30 should be approx. 20 ° C and should not exceed 23 ° C. If the temperature exceeds 23 ° C, ice or cool water should be placed around the tube to reduce the temperature.

- 15- DK 174117 B1- 15- DK 174117 B1

Efter én time afbrydes ventilatoren 35 og temperatursty-ringsindretningen 29. De ovenfor vejede objekter vejes igen, og deres vægt angives med én decimal.After one hour, the fan 35 and the temperature control device 29 are switched off. The objects weighed above are weighed again and their weight is indicated by one decimal place.

5 Vandtabet kan derefter beregnes under anvendelse af følgende formel: G^TVXt.The water loss can then be calculated using the following formula: G ^ TVXt.

1.000 10 idet G = gasstrømning i liter per minut TV = respirationsvolumen i ml f = åndedrætsfrekvens per minut t = testens varighed i minutter.1,000 10 with G = gas flow in liters per minute TV = volume of respiration in ml f = respiratory rate per minute t = duration of test in minutes.

15 Ydermere kan det procentuelle areal af kredsløbet også beregnes under anvendelse af følgende formel: E_100.(Wi-Wf)In addition, the percentage area of the circuit can also be calculated using the following formula: E_100. (Wi-Wf)

Vil 20 hvor E = effektiviteten wt = testkredsløbets vægt før testen, målt i g Wf = testkredsløbets vægt efter testen, målt i g W;, = patientattrappens vægttab målt i g 25 Dette tal bør ikke overstige 10%. Hvis det overstiger 10%, er forsøget ugyldigt og skal gentages.Will 20 where E = efficiency wt = test circuit weight before test, measured in g Wf = weight of test circuit after test, measured in g W ;, = weight loss of patient dummy measured in g 25 This figure should not exceed 10%. If it exceeds 10%, the attempt is invalid and must be repeated.

Endelig kan patientens vandtab beregnes ud fra følgende formel:Finally, the patient's water loss can be calculated from the following formula:

pi-SLPI-SL

GG

30 -16- DK 174117 B1 hvor PL = patientens vandtab målt i mg vand per liter luft, og30 -16- DK 174117 B1 where PL = the patient's water loss measured in mg of water per liter of air, and

Wi og G har de ovenfor anførte betydninger.Wi and G have the above meanings.

55

AEROSOLSAMMENLIGNINGSTESTAEROSOLSAMMENLIGNINGSTEST

Udstyret omfatter en forstøver 50 af den type, der forhandles af Devilbiss som Model 40. Forstøverens indløb 10 forbindes til et filter 51, og står via en styreventil 52 i forbindelse med atmosfæren. Forstøveren 50's udløb forbindes til indgangsåbningen på et testfilter 53 gennem et rør 54. Røret modtager desuden luft fra et andet indløb gennem en luftstrømningsmåler 55, en styreventil 56 og et 15 beskyttelsesfilter 57.The equipment comprises a nebulizer 50 of the type marketed by Devilbiss as Model 40. The nebulizer inlet 10 is connected to a filter 51 and is connected to the atmosphere via a control valve 52. The outlet of the nebulizer 50 is connected to the inlet opening of a test filter 53 through a tube 54. The tube additionally receives air from a second inlet through an air flow meter 55, a control valve 56 and a protective filter 57.

Testfilteret 53’s udløb er forbundet til en vakuumkilde (ikke vist) gennem et beskyttelsesfilter 58 og et vakuummeter 59. Udløbet er desuden forbundet til en væskekolli-20 sionsprøveudtager 60 med udløb 61, der er styret af en ventil.The outlet of the test filter 53 is connected to a vacuum source (not shown) through a protective filter 58 and a vacuum meter 59. The outlet is further connected to a liquid collision sampler 60 with outlet 61 controlled by a valve.

Første trin er forberedelsen af en bakterieopløsning.The first step is the preparation of a bacterial solution.

Dette gøres ved at pode 100 ml tryptonsoyabuillon af en 25 enkelt koloni fra en tryptonsoyaagarafskæring. Denne kultur inkuberes til den følgende dag i et rystevandbad ved 30 + 2 °C for at sikre optimal vækst.This is done by inoculating 100 ml of tryptone soy broth of a 25 single colony from a tryptone soy agar cut. This culture is incubated for the following day in a shaking water bath at 30 + 2 ° C to ensure optimal growth.

Derefter centrifugeres 5 ml portioner af kulturen fra den 30 foregående dag (ved omtrent 2300 9 i 10 minutter). Super-natanten fjernes, og celleklumperne resuspenderes i 3 ml sterilt vand. De vaskede celler samles derefter ved igen at centrifugere ved omtrent 2300 g i 10 minutter. De va- -17- DK 174117 B1 skede celleklumper resuspenderes derpå igen i tilstrækkelig sterilt vand til at give en cellesuspension på omtrent lxlO8 bakterier/ml.Then, 5 ml portions of the culture are centrifuged from the previous 30 days (at approximately 2300 9 for 10 minutes). The supernatant is removed and the cell lumps resuspended in 3 ml of sterile water. The washed cells are then pooled by centrifuging again at approximately 2300 g for 10 minutes. The sheathed cell clumps are then resuspended in sufficient sterile water to give a cell suspension of approximately 1x10 8 bacteria / ml.

5 En gramfarvning udføres dernæst. Udførelsen undersøges ved hjælp af compoundmikroskop med et kalibreret okkular-mikrometermål og en olieiramersionsobjektivlinse (x 100) . Adskillige mikroskopfelter undersøges for organismestørrelse og cellearrangement. Pseudomonas diminuta bakteri-10 erne skal være gram-negative, stavformede organismer og omkring 0,3-0,4 μιη x 0,6-1,0 μιη i størrelse samt fortrinsvis optræde som enkelte celler.A gram staining is then performed. The performance is investigated by means of compound microscope with a calibrated ocular micrometer target and an oil irradiation lens (x 100). Several microscope fields are examined for organism size and cell arrangement. The Pseudomonas diminuta bacteria must be gram-negative, rod-shaped organisms and about 0.3-0.4 μιη x 0.6-1.0 μιη in size and preferably act as single cells.

Derpå kontrolleres udstyret for strømningshastighed. Ved 15 denne kontrol fjernes testfilteret 53 og erstattes af en strømningsmåler (ikke vist). Forstøveren 50 påfyldes 5 ml sterilt vand, og kollisionsprøveudtageren 60 påfyldes 20 ml sterilt vand. Styreventilen 52 til forstøveren 50 lukkes, og styreventilen 60 til luftstrømnings- måleren 55 20 åbnes, vakuum skabes, og luft trækkes ind i udstyret i 30 sekunder. Ved 0,5 bar vakuum eller mere skal luftgennemstrømningen være 28 1/min afhængigt af kollisionsprøveudtageren 60's kritiske åbning.Then the flow rate equipment is checked. At this check, the test filter 53 is removed and replaced by a flow meter (not shown). Atomizer 50 is filled with 5 ml of sterile water and collision sampler 60 is filled with 20 ml of sterile water. The control valve 52 for the nebulizer 50 is closed, and the control valve 60 for the air flow meter 55 20 is opened, a vacuum is created and air is drawn into the equipment for 30 seconds. At 0.5 bar vacuum or more, the air flow rate must be 28 l / min depending on the critical opening of the collision sampler 60.

25 Forstøveren 50 aktiveres derpå ved en fuldstændig åbning af den tilhørende styreventil 52. Samtidig lukkes luftstrømningsmåleren 55's styreventil 56 delvist til opretholdelse af en luftgennemstrømning på 28 1/min gennem ap-paratet. Strømningshastigheden som vist på luftstrøm-30 ningsmåleren 55 gennem den tilhørende styreventil 56 registreres dernæst. Apparatet køres i 20 min. for at sikre, at luftgennemstrømningen på 28 1/min opretholdes.The atomizer 50 is then actuated by fully opening the associated control valve 52. At the same time, the air flow meter 55's control valve 56 is partially closed to maintain an air flow of 28 l / min through the apparatus. The flow rate as shown on the air flow meter 55 through the associated control valve 56 is then recorded. The device runs for 20 minutes. to ensure that the air flow rate of 28 l / min is maintained.

- 18- DK 174117 B1- 18- DK 174117 B1

Udstyret kontrolleres derpå med hensyn til opsamling af Pseudomonas diminuta-bakterierne. For at gøre dette fjernes det på fig. 7 viste testfilter 53 og erstattes af en 6-trins Anderson prøveudtager. Glaspetriskålen, der hører 5 til prøveudtageren, fyldes derpå med tryptonsoyaagar på hvert trin. luften, hvorfra der skal udtages prøver, indføres gennem prøveudtagerens åbning og hvirvler gennem de efterfølgende åbningstrin med til stadighed stigende åbningshastigheder fra trin 1 til trin 6. Successivt mindre 10 partikler slår til at begynde med ned på agaropsamlingsoverfladerne på hvert trin.The equipment is then checked for collection of the Pseudomonas diminuta bacteria. To do this, it is removed in FIG. 7 test filter 53 shown and is replaced by a 6-stage Anderson sampler. The glass petri dish belonging to the sampler is then filled with tryptone soya agar at each stage. The air from which samples are to be taken is introduced through the sampler orifice and swirls through the subsequent orifice stages with increasing rates of opening from step 1 to step 6. Gradually smaller 10 particles initially strike the agar collection surfaces at each stage.

Derpå fortyndes 1 ml af omtrent 1 x lOVral Pseudomonas diminuta suspension til 1 x lOVml ved hjælp af sterilt 15 vand. Forstøveren 50 påfyldes 5 ml af denne opløsning.Then, 1 ml of approximately 1 x LOVral Pseudomonas diminuta suspension is diluted to 1 x 10 ml with sterile water. Atomizer 50 is filled with 5 ml of this solution.

Med styreventilen 56 åben og styreventilen 52 lukket skabes vakuum i udstyret, og luft trækkes ind i dette i 30 sekunder. Ved 0,5 bar vakuum eller mere vil luftgennem-20 strømningen være 28 1/min afhængig af kollisionsprøveud-tagerens kritiske åbning.With control valve 56 open and control valve 52 closed, vacuum is created in the equipment and air is drawn into it for 30 seconds. At 0.5 bar vacuum or more, the air flow rate will be 28 l / min depending on the critical aperture of the collision sampler.

Derpå aktiveres forstøveren 50 ved fuldstændig åbning af den tilhørende styreventil 52. Samtidig lukkes styreven-25 tilen 56 delvist til det forudbestemte niveau, der bestemtes ved strømningshastighedskontroltesten. Dette sikrer gennemstrømning af suppleringsluft og opretholder luftgennemstrømningen på 28 1/min gennem apparatet. Efter en testtid på 15 min lukkes ventilen 52, og ventilen 56 30 åbnes helt. Efter yderligere 30 sekunder til fjernelse af aerosol fra systemet afbrydes vakuumkilden.Then, the nebulizer 50 is activated by fully opening the associated control valve 52. At the same time, the control valve 56 is partially closed to the predetermined level determined by the flow rate control test. This ensures the flow of supplementary air and maintains the air flow of 28 l / min through the apparatus. After a test time of 15 minutes, valve 52 closes and valve 56 30 opens completely. After an additional 30 seconds to remove the aerosol from the system, the vacuum source is disconnected.

-19- DK 174117 B1-19- DK 174117 B1

Agaropsamlingspladerne fjernes derpå fra Anderson prø-veudtageren og inkuberes ved 30 ± 2 °C. De kolonidannende enheder (ctu) tælles efter 24 og 48 timer.The agar collection plates are then removed from the Anderson sampler and incubated at 30 ± 2 ° C. The colony forming units (ctu) are counted after 24 and 48 hours.

5 Udstyret er funktionsdygtigt, hvis Pseudomonas diminuta opsamles på trinene 6 eller 5 i Anderson prøveudtageren.5 The equipment is functional if Pseudomonas diminuta is collected at steps 6 or 5 of the Anderson sampler.

Dette bekræfter, at monodisperse organismer produceres af udstyret.This confirms that monodisperse organisms are produced by the equipment.

10 Efter disse tests bruges udstyret til at måle filtrenes effektivitet på følgende måde.10 After these tests, the equipment is used to measure the efficiency of the filters as follows.

Et testfilter 53 indsættes i udstyret som vist på fig. 7.A test filter 53 is inserted into the equipment as shown in FIG. 7th

20 ml sterilt vand anbringes i væskeprøveudtageren 60, og 15 forstøveren påfyldes 5 ml 1 x 10® ml Pseudomonas diminuta opløsning.20 ml of sterile water is placed in the liquid sampler 60 and the nebulizer is filled with 5 ml of 1 x 10 10 ml of Pseudomonas diminuta solution.

Derpå åbnes styreventilen 56, og styreventilen 52 lukkes. Vakuum skabes i udstyret, og luft trækkes ind i apparatet 20 i 30 sekunder. Ved 0,5 bar vakuum eller mere vil luft:?· strømningen være 28 ]/min afhængigt af den kritiske åbning af væskeprøveudtageren 60. Derpå aktiveres forstøveren 50 ved fuldstændig åbning af den tilhørende styreventil 52 og delvis lukning af styreventilen 56 til niveauet 25 bestemt ved funktionstesten for at opretholde en luftstrøm på 28 1/min.The control valve 56 is then opened and the control valve 52 is closed. Vacuum is created in the equipment and air is drawn into the device 20 for 30 seconds. At 0.5 bar vacuum or more, air: flow will be 28] / min depending on the critical opening of the liquid sampler 60. Then, the nebulizer 50 is activated by fully opening the associated control valve 52 and partially closing the control valve 56 to the level 25 determined at the function test to maintain an air flow of 28 l / min.

Efter en testtid på 15 minutter lukkes ventilen 52, og ventilen 56 åbnes fuldstændigt. Efter yderligere 30 se-30 kunder til fjernelse af aerosol fra systemet slås vakuumkilden fra.After a test time of 15 minutes, valve 52 closes and valve 56 opens completely. After a further 30 se-30 customers to remove aerosol from the system, the vacuum source is switched off.

-20- DK 174117 B1 Væsken, der er tilbage i forstøveren 50, trækkes derpå ud ved hjælp af en 5 ml sprøjte med en nål. Det tilbageværende volumen måles derpå ved brug af et 10 ml glasmåle-bæger, og dette volumen seriefortyndes derpå ti gange med 5 vand syv gange i træk. Fortyndinger, der indeholder omtrent 102 bakterier pr. ml, filtreres derpå gennem en 0,2 μπι analysemembran ved brug af sterifiler. Analysemembranerne placeres derpå på tryptonsoyaagarplader, der inkuberes ved 30 ± 2 °C. Cfu tælles efter 24 og 48 timer, og 10 antallet af kolonier på membraner, der viser mellem 20 og 200 kolonier, registreres.-20- GB 174117 B1 The liquid remaining in the nebulizer 50 is then withdrawn by means of a 5 ml syringe with a needle. The remaining volume is then measured using a 10 ml glass measuring cup, and this volume is then diluted ten times with 5 water seven times in a row. Dilutions containing about 102 bacteria per is then filtered through a 0.2 μπι assay membrane using sterifiles. The assay membranes are then placed on tryptone soya agar plates incubated at 30 ± 2 ° C. Cfu is counted after 24 and 48 hours and the number of colonies on membranes showing between 20 and 200 colonies is recorded.

Forstøversammenligningstiteren udregnes derpå. Væsken i kollisionsprøveudtageren udtages derpå ligeledes. Væskens 15 volumen måles ved brug af et 20 ml glasmålebæger, og dette volumen seriefortyndes ti gange med sterilt vand og tre gange i træk. Den tilbageværende rene opløsning og fortyndingerne filtreres gennem en 0,2 μπι analysemembran ved brug af sterifiler. Analysemembranerne placeres på 20 tryptonsoyaagarplader, og åbningen af kollisionsprøven undersøges for at sikre, at den ikke er tilstoppet.The nebulizer comparison titer is then calculated. The liquid in the collision sampler is then also withdrawn. The volume of the liquid is measured using a 20 ml glass measuring cup and this volume is diluted ten times with sterile water and three times in a row. The remaining pure solution and dilutions are filtered through a 0.2 μπι assay membrane using sterifils. The analysis membranes are placed on 20 tryptone soya agar plates and the opening of the collision test is examined to ensure that it is not clogged.

Agarpladerne inkuberes derpå ved 30 ± 2 °C. Cfu tælles efter 24 og 48 timer, og antallet af kolonier på membra-25 ner, der viser mellem 20 og 200 kolonier, registreres, og antallet af bakterier, der er genindvundet nedstrøms for filteret, udregnes. Udstyrets effektivitet udregnes derpå fra formlen:The agar plates are then incubated at 30 ± 2 ° C. Cfu is counted after 24 and 48 hours, and the number of colonies on membranes showing between 20 and 200 colonies is recorded and the number of bacteria recovered downstream of the filter is calculated. The efficiency of the equipment is then calculated from the formula:

Bt x 100 30 Re=~-Bt x 100 30 Re = ~ -

Tf«Vn hvor Re = udstyrseffektiviteten målt i procent DK 174117 B1 -21 -Tf «Vn where Re = equipment efficiency measured as a percentage DK 174117 B1 -21 -

Bt = totale antal fundne bakterierBt = total number of bacteria found

Tf = det endelige forstøvede titer i CFU/mlTf = final atomized titer in CFU / ml

Vn = the forstøvede volumen 5 Bakteriepåvirkningen på filteret beregnes på grundlag af følgende formel: C = Vn *Re «Πξ 10 hvor C = total påvirkningVn = the atomized volume 5 The bacterial effect on the filter is calculated on the basis of the following formula: C = Vn * Re «Πξ 10 where C = total influence

Vn og Re har den ovenfor angivne betydning, og Nt er forstøvningspåvirkningstiteren i CFU/ml.Vn and Re have the meaning given above and Nt is the nebulizer titer in CFU / ml.

Derefter beregnes reduktionen af filtreret titer på 15 grundlag af følgende formel:Then, the reduction of filtered titer is calculated on the basis of the following formula:

CC

TR =-TR = -

Bt hvor TR = filtertiterreduktionen, og C og B- har den ovenfor angivne betydning.Bt where TR = filter titer reduction and C and B- have the meaning given above.

2020

Ud fra ovenstående kan den procentuelle filtereffektivitet beregnes på grundlag af følgende formel: roFrom the above, the percentage filter efficiency can be calculated on the basis of the following formula: ro

Filteref fektivitet=l--X100 25 Vandtabet blev målt som beskrevet ovenfpr. Respirationsvolumenet var 660 ml, hastigheden 15 åndedrag pr. minut, og patientattråppens udåndingstemperatur var 32 °C.Filter efficiency = 1 - X100 25 Water loss was measured as described above. The volume of respiration was 660 ml, the rate of 15 breaths per minute. The patient's exhalation temperature was 32 ° C.

Bakteriefjernelseseffektiviteten blev testet ved aerosol-30 sammenligningstest som beskrevet ovenfor, med Pseudomonas diminuta. Virusfjernelseseffektiviteten blev testet ved -22- DK 174117 B1 en aerosolsammenligningstest af den ovenfor beskrevne art med M52 bakteriofag.The bacterial removal efficiency was tested by aerosol comparison test as described above, with Pseudomonas diminuta. Virus removal efficiency was tested by an aerosol comparison test of the type described above with M52 bacteriophage.

Resultaterne er vist i tabel I.The results are shown in Table I.

TABEL 1TABLE 1

Fjernelseseffektivitetremoval Efficiency

Filter Type Vandtab Bakterier (%) Virus (%) mg/1 2A 10, 1 99, 9976 99, 999 2B 5,3 99,91 Ingen data 3A 8,9 99, 9992 99,999 (påstået) 3B 10,4 99,999 99,999 M3A 4,2 99, 95 99,1 M3B 7,0 99,981 Ingen dataFilter Type Water Loss Bacteria (%) Virus (%) mg / 1 2A 10, 1 99, 9976 99, 999 2B 5.3 99.91 No data 3A 8.9 99, 9992 99.999 (alleged) 3B 10.4 99.999 99.999 M3A 4.2 99, 95 99.1 M3B 7.0 99.981 No data

Filteret ifølge 8,4 + 0,4 99,999 99,999 opfindelsen (n=18) 5The filter according to the 8.4 + 0.4 99.999 99.999 invention (n = 18) 5

Som det vil fremgå, havde filtrene fra anden kategori enten et højt vandtab med en relativt høj fjernelseseffektivitet (2A) eller et meget lavere vandtab, men med en tilsvarende reduceret fjernelseseffektivitet (2B) (sam-10 menlignet med fjernelseseffektiviteten på 99,9977% som af Lloyd og Roe angives som minimum til klinisk brug). Filtrene fra tredie kategori havde meget højere fjernelseseffektivitet, men forholdsvis høje vandtab. De modificerede filtre fra tredie kategori havde meget lavere vandtab som 15 følge af det hydroskopiske materiales tilstedeværelse, men havde forholdsvis meget lavere fjernelseseffektivitet. I modsætning hertil havde det ovenfor og med henvisning til tegningerne beskrevne filter ifølge opfindelsen en høj fjernelseseffektivitet og forholdsvis lavt vandtab 20 (mindre end 8,5 ml/1).As will be seen, the filters of the second category had either a high water loss with a relatively high removal efficiency (2A) or a much lower water loss, but with a correspondingly reduced removal efficiency (2B) (compared with the removal efficiency of 99.9977% as of Lloyd and Roe as a minimum for clinical use). The third-category filters had much higher removal efficiency but relatively high water losses. The modified third-category filters had much lower water losses due to the presence of the hydroscopic material, but had relatively much lower removal efficiency. In contrast, the filter of the invention described above and with reference to the drawings had a high removal efficiency and relatively low water loss 20 (less than 8.5 ml / l).

-23- DK 174117 B1-23- DK 174117 B1

Det ovenfor med henvisning til fig. 1 beskrevne filter med de i tabel 1 anførte testresultater blev desuden monteret i en ventilator ved en klinisk test og sammenlignet 5 med det kommercielt tilgængelige filter 3A fra tabel 2. Filtrene blev testet under to betingelser (A og B) som angivet i tabel 2, og vandtabet baseret på brug i 24 timer. Ved betingelse A var respirationsvolumenet 480 ml ved 15 åndedrag/min og udåndingstemperaturen på 32,4 ± 10 1,0 °C. Ved betingelse B var respirationsvolumenet 780 ml ved 15 åndedrag/min og udåndingstemperaturen 33,2 ± 1,0 °C.Referring to FIG. In addition, 1 filter described with the test results set forth in Table 1 was mounted in a fan in a clinical test and compared 5 with the commercially available filter 3A from Table 2. The filters were tested under two conditions (A and B) as listed in Table 2. and water loss based on use for 24 hours. At Condition A, the volume of respiration was 480 ml at 15 breaths / min and the exhalation temperature of 32.4 ± 10 1.0 ° C. At Condition B, the volume of respiration was 780 ml at 15 breaths / min and the exhalation temperature was 33.2 ± 1.0 ° C.

TABEL 2TABLE 2

Filter type Vandtab (mg (H20)/1 iUft)Filter Type Water Loss (mg (H2 O) / 1 iUft)

Betingelse A Betingelse BCondition A Condition B

3A 7,2 ± 1,1 (n=12) 12,1 ± 1,2 (n=12)3A 7.2 ± 1.1 (n = 12) 12.1 ± 1.2 (n = 12)

Filteret ifølge 5,3 ± 1,0 (n=12) 8,8 i 1,2 (n=12) opfindelsen 15 Det vil fremgå, at ved begge funktionsbetingelser udviser filteret beskrevet med henvisning til tegningen et stærkt reduceret vandtab.The filter according to 5.3 ± 1.0 (n = 12) 8.8 in 1.2 (n = 12) invention 15 It will be seen that in both operating conditions, the filter described with reference to the drawing exhibits a greatly reduced water loss.

Dette reducerede vandtab opretholdes ved en lang række 20 funktionsbetingelser. Af tabel 3 nedenfor fremgår det vandtab, der forekommer ved de specificerede, forskellige funktionsbetingelser for ventilatoren. Det fremgår heraf, at over et bredt område af minutvolumener (respirationsvolumen x frekvens) fra 7,2 1/min til 12 1/min varierer 25 vandtabet ikke signifikant (7 mg/] til 10 mg/]) ved en konstant temperatur (32 °C) .This reduced water loss is maintained at a wide range of 20 operating conditions. Table 3 below shows the water loss that occurs with the specified different operating conditions of the fan. It can be seen that over a wide range of minute volumes (respiratory volume x frequency) from 7.2 l / min to 12 l / min, the water loss does not vary significantly (7 mg /] to 10 mg /]) at a constant temperature (32 ° C).

-24- DK 174117 B1-24- DK 174117 B1

Ved de ovenstående eksempler anvendes specifikke materialer. Det vil imidlertid være indlysende, at andre egnede hydrofobe og hydrofile materialer kan anvendes til filtre af den ovenfor beskrevne type.In the above examples, specific materials are used. However, it will be obvious that other suitable hydrophobic and hydrophilic materials can be used for filters of the type described above.

55

Selv om de ovenfor anførte eksempler vedrører medicinsk anvendelse, kan kombinationen af hydrofilt og hydrofobt materiale anvendes andre steder, hvor indåndings- og udåndingsluft filtreres, og hvor der opstår et problem, der 10 kræves brug af et varme- og fugttilbageholdende filter. Eksempelvis kan dette være tilfældet, hvis luftforsyningen i en flykabine sker gennem et filter og ikke har en passende temperatur og fugtighed. Anvendelsen af et filter af den ovenfor beskrevne type kan tilvejebringe en 15 forsyning af luft til en flykabine, hvilken luft har den ønskede temperatur og fugtighed.Although the above examples relate to medical use, the combination of hydrophilic and hydrophobic material may be used elsewhere where inhalation and exhalation air is filtered and where a problem arises which requires the use of a heat and moisture retaining filter. For example, this may be the case if the air supply in an aircraft cabin is through a filter and does not have the appropriate temperature and humidity. The use of a filter of the type described above can provide a supply of air to an aircraft cabin which has the desired temperature and humidity.

tabel 3Table 3

Respirationsvolumen 480 660 800 1000 660 660 (ml)Respiratory volume 480 660 800 1000 660 660 (ml)

Frekvens (bpm) 15 15 15 10 15 15Frequency (bpm) 15 15 15 10 15 15

Temperatur °C 32 32 32 32 30 34Temperature ° C 32 32 32 32 30 34

Min. volumen 1/min 7,2 9,9 12,0 10,0 9,9 9,9Mine. volume 1 / min 7.2 9.9 12.0 10.0 9.9 9.9

Vandtab mg (H;0) llu.t 8,110,2 8,4±0,4 8,6±0,8 9,4±0,5 7,3±0,5 10,05 (n-5) (n=18) (n=3) (n=4) (n=3) (n=2) 20Water loss mg (H; 0) llu.t 8.110.2 8.4 ± 0.4 8.6 ± 0.8 9.4 ± 0.5 7.3 ± 0.5 10.05 (n-5) ( n = 18) (n = 3) (n = 4) (n = 3) (n = 2) 20

Claims (17)

1. Varme- og fugtighedsvekslende filter omfattende 5 et hus med en første del for tilslutning til en forsyning af indåndelig gas og et udåndingsrør samt en anden del til forbindelse med en person, der indånder og udånder gassen, hvor huset indeholder et lag hydrofilt filtermateriale (11) og et lag hydrofobt filtermateriale (10) an-10 bragt i serie i en strømningsvej mellem den første og den anden del, hvor det hydrofile materiale (11) er nærmest den første del i den nævnte strømningsvej, kendetegnet ved, at det hydrofobe materiale (10) har et alkoholboble-punkt højere end 710 mm (28") H20 til fjernelse af mikro-15 organismer.A heat and moisture exchange filter comprising a housing with a first portion for connection to a supply of breathable gas and an exhalation tube, and a second portion for connection with a person breathing and exhaling the gas, wherein the housing contains a layer of hydrophilic filter material ( 11) and a layer of hydrophobic filter material (10) arranged in series in a flow path between the first and second portions, wherein the hydrophilic material (11) is closest to the first portion of said flow path, characterized in that the hydrophobic material (10) has an alcohol bubble point higher than 710 mm (28 ") H2 O to remove micro-organisms. 2. Filter ifølge krav 1, kendetegnet ved, at det hydrofile materialelag (11) er i kontakt med det hydrofobe materialelag (10). 20Filter according to claim 1, characterized in that the hydrophilic material layer (11) is in contact with the hydrophobic material layer (10). 20 3. Filter ifølge krav 2, kendetegnet ved, at lagene (10, 11) er indbyrdes forbundne.Filter according to claim 2, characterized in that the layers (10, 11) are interconnected. 4. Filter ifølge krav 2, kendetegnet ved, at lagene 25 (10, 11) er laminerede.Filter according to claim 2, characterized in that the layers 25 (10, 11) are laminated. 5. Filter ifølge et hvilket som helst af kravene 1- 4, kendetegnet ved, at det hydrofobe materiale (10) er fremstillet af keramiske fibre s ammen limede med en har- 30 piks. 1 35 Filter ifølge et hvilket som helst af kravene 1- 5, kendetegnet ved, at det hydrofile materiale (11) er et cellulosemateriale. -26- DK 174117 B1Filter according to any one of claims 1-4, characterized in that the hydrophobic material (10) is made of ceramic fibers which are glued to the resin with a resin. Filter according to any one of claims 1 to 5, characterized in that the hydrophilic material (11) is a cellulose material. -26- DK 174117 B1 7. Filter ifølge et hvilket som helst af kravene 1-6, kendetegnet ved, at lagene af filtermateriale (10, 11) er foldede.Filter according to any one of claims 1-6, characterized in that the layers of filter material (10, 11) are folded. 8. Filter ifølge krav 7, kendetegnet ved, at huset omfatter et kammer omgivet af en ydre væg med to åbninger i hver sin ende af huset, hvor den ene åbning udgør en forbindelsesdel for den nævnte forsyning af indåndelig gas og den nævnt'e udåndingsrørdel, og den anden åbning 10 omfatter en forbindelsesdel til den nævnte person, der ind- og udånder gassen, og hvor de foldede lag (10, 11) fylder det nævnte kammer således, at folderne på den ene side støder op til den ene del, og folderne på den anden side af lagene støder op til den anden del. 15Filter according to claim 7, characterized in that the housing comprises a chamber surrounded by an outer wall with two openings at each end of the housing, the one opening forming a connecting part for said supply of breathable gas and said exhalation pipe part. and said second aperture 10 comprises a connecting portion to said person inhaling and exhaling the gas and wherein said folded layers (10, 11) fill said chamber such that the folds abut one side on one side, and the folds on the other side of the layers are adjacent to the other part. 15 9. Filter ifølge et hvilket som helst af kravene 1- 8, kendetegnet ved, at laget af hydrofilt materiale (11) er kontinuert.Filter according to any one of claims 1-8, characterized in that the layer of hydrophilic material (11) is continuous. 10. Filter ifølge et hvilket som helst af kravene 1- 8, kendetegnet ved, at laget af hydrofilt materiale (11) er forsynet med et antal parallelle, gennemgående slidser i indbyrdes afstand fra hinanden.Filter according to any one of claims 1-8, characterized in that the layer of hydrophilic material (11) is provided with a number of parallel, continuous slots spaced apart. 11. Filter ifølge et hvilket som helst af kravene Ι- ΙΟ, kendetegnet ved, at filteret har et tryktab, der ikke er større end 3,0 cm HsO ved en luftgennemstrømning på 60 1/min.Filter according to any one of claims Ι-ΙΟ, characterized in that the filter has a pressure drop not greater than 3.0 cm HsO at an air flow of 60 l / min. 12. Filter ifølge et hvilket som helst af kravene 1- 11, kendetegnet ved, at filteret har en aerosol bakteriefjernelseseffektivitet, der er større end 99, 999% målt ved en aerosolsammenligningstest.Filter according to any one of claims 1- 11, characterized in that the filter has an aerosol bacterial removal efficiency greater than 99, 999% as measured by an aerosol comparison test. 13. Filter ifølge et hvilket som helst af kravene 1- 12, kendetegnet ved, at filteret har et vandtab (som de- -27- DK 174117 B1 fineret i beskrivelsen) på mellem 7 mg/1 og 10 mg/1 i et minutvolumeninterval fra 7 1/min til 12 1/min ved en temperatur på 32 °C. 5 14. Åndingskredsløb kendetegnet ved/ at det omfatter en ventilator (35), et rør (37) til forbindelse af ventilatoren til den første del af et filter ifølge et hvilket som helst af kravene 1-13, og et udåndingsrør (33) fra den nævnte første del og et rør, der fører fra den anden 10 del af det nævnte filter til en person, der ind- og udånder gassen fra ventilatoren.Filter according to any one of claims 1- 12, characterized in that the filter has a water loss (as defined in the specification) of between 7 mg / 1 and 10 mg / 1 in a minute volume range. from 7 l / min to 12 l / min at a temperature of 32 ° C. A respiratory circuit characterized by / comprising a fan (35), a tube (37) for connecting the fan to the first portion of a filter according to any one of claims 1-13, and an exhalation tube (33) from said first portion and a pipe passing from said second portion of said filter to a person breathing and exhaling the gas from the fan. 15. Fremgangsmåde til fremstilling af et varme- og fugtighedsvekslende filter omfattende anvendelse af et 15 lag hydrofobt materiale (10) med to indbyrdes modstående yderflader og et lag hydrofilt materiale (11) med to indbyrdes modstående yderflader, kendetegnet ved, at laget af hydrofobt materiale har et alkoholboblepunkt, der er større end 710 mm (28") H^O, og ved at en yderflade af 20 det hydrofobe materiale forbindes med en yderflade af det hydrofile materiale.A method of producing a heat and moisture exchange filter comprising the use of a 15 layer hydrophobic material (10) having two mutually opposite outer faces and a layer of hydrophilic material (11) having two mutually opposite outer faces, characterized in that the layer of hydrophobic material has an alcohol bubble point greater than 710 mm (28 ") H 2 O, and by connecting an outer surface of the hydrophobic material to an outer surface of the hydrophilic material. 16. Fremgangsmåde ifølge krav 15, kendetegnet ved, at forbindelsen mellem den nævnte overflade af det hydro- 25 fobe materiale (10) med nævnte overflade af det hydrofile materiale (11) omfatter sammenlimning.Method according to claim 15, characterized in that the connection between said surface of the hydrophobic material (10) with said surface of the hydrophilic material (11) comprises bonding. 17. Fremgangsmåde ifølge krav 15, kendetegnet ved, at forbindelsen mellem den nævnte overflade af det hydro- 30 fobe materiale med nævnte overflade af det hydrofile materiale sker ved laminering.Method according to claim 15, characterized in that the connection between said surface of the hydrophobic material with said surface of the hydrophilic material takes place by lamination. 18. Fremgangsmåde ifølge et hvilket som helst af kravene 15-17, kendetegnet ved, at det hydrofobe materia- 35 le (10) udgøres af keramiske fibre sammenlimede med har- -28- DK 174117 B1 piks, og hvor det hydrofile materiale (11) er et cellulosemateriale .Method according to any one of claims 15-17, characterized in that the hydrophobic material (10) is made of ceramic fibers bonded with resin and the hydrophilic material (11). ) is a cellulose material. 19. Fremgangsmåde ifølge et hvilket som helst at 5 kravene 15-18, kendetegnet ved, yderligere at omfatte foldning af de indbyrdes forbundne materialelag (10, 11).A method according to any one of claims 15-18, characterized in further comprising folding the interconnected material layers (10, 11).
DK199300701A 1992-06-11 1993-06-11 Heat and moisture exchanging filters and breathing circuits comprising a filter of this kind and method for making such a filter DK174117B1 (en)

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DK70193D0 (en) 1993-06-11
AU4018493A (en) 1993-12-16
GB9311889D0 (en) 1993-07-28
FR2692153A1 (en) 1993-12-17
NO932126D0 (en) 1993-06-10
NO302861B1 (en) 1998-05-04
DE4319458A1 (en) 1993-12-16
SE9301970L (en) 1993-12-12
JPH0663141A (en) 1994-03-08
SE510976C3 (en) 1999-08-30
FR2749173A1 (en) 1997-12-05
NL194750C (en) 2003-02-04
IT1260845B (en) 1996-04-23
GB2267661B (en) 1995-10-18
DE4319458B4 (en) 2005-06-09
CA2098132A1 (en) 1993-12-12
SE510976C2 (en) 1999-07-19
NL9301022A (en) 1994-01-03
NO932126L (en) 1993-12-13
CH687297A5 (en) 1996-11-15
FI932661A0 (en) 1993-06-10
DK70193A (en) 1993-12-12
ITTO930424A0 (en) 1993-06-10
ES2074002A2 (en) 1995-08-16
ITTO930424A1 (en) 1994-12-10
FR2749173B1 (en) 1998-11-06
NL194750B (en) 2002-10-01
FI932661A (en) 1993-12-12
CA2098132C (en) 2000-10-17
FI110236B (en) 2002-12-31
AU667538B2 (en) 1996-03-28
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SE9301970D0 (en) 1993-06-09
GB2267661A (en) 1993-12-15
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GB9212399D0 (en) 1992-07-22
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