DD299576A7 - METHOD AND DEVICE FOR CLEANING AND PACKAGING CATHETERS - Google Patents

Abstract

The invention relates to a method and a device for cleaning and subsequent packaging of medical tubes, such as catheters or probes, at the manufacturer or in medical facilities after use. In the method, the catheter (11) in a spuelot, the bottom opening (18) is closed with a stopper (13) mounted vertically and in the lumen (12) is a mixture of a volume of cleaning liquid, preferably ultrapure water and one to five Volume parts compressed gas bubbles. The mixture exits the lumen (12) at the lower end and subsequently cleans the outer surface of the catheter. The device avoids recontamination of the catheter (11) prior to packaging. The control of the cleaning process is carried out according to the degree of loading of the cleaning liquid. Fig. 2 {catheter; irrigation tube; Floor opening, locked, vertical, hang; lumen; Reinigungsfluessigkeit; ultrapure water; Gas bubbles, press in, clean; Surface; packaging; Avoid recontamination}

Description

For this 2 pages drawings

Dio invention relates to prefetching and cleaning and cleaning. subsequent packaging of medical shoe length or length, such as catheters or probes, at the point of manufacture or in medical facilities after use.

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Characteristic d © 3 hokonnteri StQndos of technology -,. '

For the purification of medical tubing, hereinafter generally referred to as a catheter, of infection matorial after Ersigobrauch, it is known to augment the catheter on a neck and to flush the lumen. Also, the flushing untor using a Informationspriuo is common and well-known. Diooer procedure takes place immediately before packing ursd sterilizing the catheters. Because of the intensive air purge, contamination of the catheters is not vermoitibar. Sn dor DE-OS 3638749, Kl. A61 L, 2/18 will bacchrioben a method in which an active oxygen-releasing Dcsinioktionslösung is pressed into the luman. The Dosinfektionslonung is mixed with a dye solution. In . o inom followorsdon rinsing process is rinsed along with water so that all Farbrosto are gegenrechwunden. During the execution of the procedure, the catheters float horizontally. In an elongated tub and the medium emerging from the catheter is collected in the tub and causes the external cleaning. During the rinsing process the effect of ultrasound on the catheter takes place.

A disadvantage of this method is the relatively high consumption of disinfectants, which causes costs and makes proper disposal necessary.

The flushing with dom disinfectants is carried out according to the schedule specified in the schedule, in which, consequently, a safety adjustment must be incorporated. One control dor Rolnhoit is not possible. It can only be determined if the dyed disinfectant was completely removed. After this process QlIe Kathater dor ambient air must be exposed in order to be subsequently packaged, which can lead to decontamination. , . '..'.

DE-OS 333GD91, Kl. B08B, 3/00 proposes the use of a metering device for disinfectants, which can be activated directly by a central drinking water line. Advantageously, hot water is used for this purpose. The deodorant solution prepared by dorart is forced through the lunar site and then discharged. Also in this metering device too much effort on Dssinfektlonsmltteln is necessary, this comes at additional cost for dio provision of hot water.

Opposite the solution according to DE-OS 3638749 is advantageous that the lumen is flowed through only with fresh solution. As a disadvantage, however, the problem of cleaning the outside of the catheter vorbloibt. Problems of protection of the purified catheters from orneutor contamination have not been addressed.

In EP-Pater.t 00117S5, C08 J, 7/02, an ancestor's removal of product-contaminated impurities and dusts from the surface of Ine's catheter is shown. In particular, holiconkautcichuk catheters arise at the mochonischon BeQf bung Franesn, Fährtchen and bumps. For the removal of these impurities, the catheter is about 5 minutes in oin organic solvent, wio Mothylenchlorldodor AcatortgotGUcht ....

This method is characterized by a high U.M. exposure, which requires air maintenance costs, and also includes a cost for the solvent to be boron-oot-boron. Finally, the preformed catheters contain multiple remodeling of the catheters, so that a goring or MscSioniolor level is expected , To all these solutions hofioi of the Ncchtoii dn, ocos oo ssitaufwondig oind and that one statement about the achieved purity is not possible. Dsgo, however, is becoming increasingly common with the Herotolbr eriiobono requirement. This purity includes, - that the catheter vorpackt immediately after cleaning and thus must be protected.

Aim of the invention,. '. /,. , ·

The aim of the invention is to reduce the consumption of disinfectant solutions in the internal and external cleaning of catheters, to shorten the cleaning times and to avoid recontamination before packaging.

Presentation «SosWeson-Otter invention, '".' '·.

Object of the invention is to provide a method and apparatus for cleaning and packaging of catheters in which umwoitvertrüglicho, kostenigr ReinigungsfligksiteneingsESzt be, a continuous measurement of Partikolornission the catheter during cleaning is mögüch and the catheter vorpcckt protected from ambient air after cleaning can be. -. , _: ,. -.

Erfindungsgcmßß the task is goiöst in that in Dom Verfahron'siim cleaning and packaging of medical hoses catheter odor another ondllchor medical horseshoe tube in ainom spühlrohr, döesen Bodenssffnung is closed with a stopper, is placed in a vertical, freely hanging bed. In this position, a Gesbiossn-containing cleaning liquid hinoinhinrück from above into the Katheierlumen as a cleaning medium and thereby goreinigt first the inside of the catheter. ^:

In a ζννοίΐοη RoSnigungsphaco the exterior of the Kathoiorc is gerainigt by the cleaning medium after leaving the Lumons flows vertically upwards and bohendelt däo outer curse Ksthctsra.

The liquid nature of the operation of the vehicle is dependent on the degree and nature of the pollution. To eliminate clinical contamination by blood ODSR Sekrsto is necessary to use beSter.ntor FJsäragungs- and Dfasinfoktionsmittellösungen. For the purpose of simple pre-emptying, as well as production of products without any secretions of the mechanical skin, it is necessary to treat ultrapure water with water. The gas is applied in accordance with the method of the invention, when it is applied to the glasswaste oil, and it is distilled in the presence of flammable gas. Cleaning Müsko Eco will be a safe gas vorwcndot. Don Gsssra may be added to dslnfeiorasTido agents, such as EthySonoxide. The Vorhültnis dot Gosamtvolumlna of Roinigusuciciläsoigkslt and beisumiochendsn gas bubbles is 1 to 3. The diameter DSIR GacibSacon Gosi wooentlich kSsänsr sain slo the Durchmoscor dec Kathsterlumens and is in the stage of Entex ^ hens bsi maximsl 1 Milümetsr. DiQ wlnzlQsn GcsbloGsn oind dio Urscicho of cleaning effects of physical Nntur. The Reinigungsmsdium is pressed with a pressure in the Kathoioriumon whose size

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depends on the length and dom diameter of the Kntheterschlsucheo. He liogt in Borsich from 0.3 to 0, SMPa. This pressure can be generated on favorable Wego by applying a Druckiuftpölsters on the storage tank for the cleaning liquid. . ' _L

The temperature of the cleaning fluid is 15 to 25 ⁰ C and »communicates with storage of the storage container in the working space without supply from Fromdonergie.

The rewiring mode according to the invention is created immediately before the adapter. In the subsequent entry into the Kathoterlumon-habon the Gasblason the endeavor to voreinigen, causing a significant turbulence of Roinigurigsrnodiumo or sound waves occur in the lumen, dio achieve the required cleaning effect. This cleaning ipt at the same time connected with a visible, jumping movement of Kathetorschlcuches. Likewise, during the flow through the catheter lumena, the mean size of the air bubbles increases.

After Vorlasnondoa 'Kathetorlumens wird.das the cleaning medium, the outer © surface of the catheter flowing around, led vertically upwards. The outer surface of Kathetarschlauches is also cleaned.

At a suitable. Stolio, which is above the uppermost end of the catheter lumen, the mixture is discharged in a pipeline. A nachgöschaltefer gas separator separates the two components gas and cleaning fluid from each other. The total time * to clean a catheter is 2 to 3 minutes, with a throughput of 2.5 liters of cleaning fluid per minute required

Upon completion of the cleaning operation, the supply of cleaning liquid is stopped while the supply of the gas flow is maintained. The cleaning liquid still in the flushing pipe is drained off and the plug is pulled out. On dio soil opening the Spülrohres a Verpackungsbeutol is plugged. The gas stream first dries the catheter inside and outside and flowers in time the packaging bag. This makes it possible to introduce the catheter contactless in don packaging bag.

When the catheter is completely surrounded by the packaging bag, the catheter and packaging bag are withdrawn together from the device. ,,

The advantages of the method according to the method are manifold. Thus, the proportion of cost-intensive and reversible liquor fl uats glycols has been reduced by the use of ultrapure water. This is possible because of the possibility of process control during the traverse sequence. Thus, at any stage of the cleaning cycle, the current state of cleaning can be detected by measurement of the particle concentration in the used cleaning liquid and, for example, switched from a disinfecting solution to an ultrapure water or the cycle can be terminated. Such a possibility does not exist in a fixed-programmed cleaning process. Here, a sufficient Sichorheitozußchlag should be provided, so that by the erfindungsgamäße method, a reduction of the cycle time is possible. ,

To detect the instantaneous state of cleaning, it is necessary to use opto-electronic opto-electronic © measuring methods with associated Fiochontochnlk. Dio measurement of Partikotemicaioncroio carried out by a granulometric analysis of the transported by dor cleaning fluid particles.

A Tsilstrom dor cleaning fluid is fed via a bypass to a grahulomotrischen sensor. Depending on the speed of the mammography acquisition and the computer evaluation evaluation, the output of the measured values takes place periodically. For each cleansing period, the output of several readings is required, for example every 10 seconds. , .

By comparing the particle size and -sohl in the cleaning liquid before and nech the cleaning of the catheter and implementation in digiiaäo display unit, it is possible to cancel the cleaning cycle bsi dsm desired result. , The subsequent removal and packaging of the catheter takes place in consideration of the greatest sepsis, as can not be achieved using known KQihertcr-WaochanlQgon. The catheter is protected from ooror recontamination in every phase of the combined cleaning and packaging process. Immediately after requesting the cleaning of this protection is exerted by the flushing pipe, while already the packaging Obsessioni is pushed onto the flushing pipe. A touch with the hand or by ambient StGUb is excluded. -

Thus, the ancestor can also be exercised in rooms with a lower degree of purity, so that © thereby further cost reduction occurs. , .

The device for carrying out the erfindungsgomäßan method bsstsht from a flushing pipe and an adapter. The flushing tube is the length of the catheter to be cleaned plus a Lfingo of 50 to 100 mm. It is closed at the bottom with a stopper. The plug has a bore into which a drain port with a drain valve is inserted.

The adapter has the form of a circular base plate having a ring groove arranged on the outer circumference. In this ring groove era sealing ring made of rubber is inserted. The adapter was located in Einbaulaga inside the flushing pipe, whereby by the sealing ring a sealing connection swicchen the inner wall dss Spülrohr® ^ and dor adapter plate is made. The fit swicchon adapter and inner rinse tube is so raked that the Adnptsr can be moved axially. For this purpose, type cäor top of the adapter, a push rod is mounted, the lung of which corresponds at least to a catheter and which protrudes from the upper opening of the flushing pipe. For the support of the cathotor during the cleaning, there is an adapter hole in the bottom of the undorsoite whose diameter is about 5% smaller than the outside diameter of the cathotor. In this hole the Kcthotorechlsuch is inserted by taking advantage of its elasticity. This makes oino continuous, that is, ansatafreia cleaning of Kathetorlumsns possible. _: ...

There is, of course, also the possibility of a traditional shiahuil (of which) the catheter tube, under widening, becomes Qufgoccitobon. However, the precondition for the use of garlic is that the uncleaned preparation does not interfere with the later application of the catheter. Di © receiving bore ce "" ii into a smaller through-hole, which drills through the adapter and passes over the dopson top in αίηαη Rohrstutzon. The pipe socket is provided with a connection to which a psriphoric siasfsncfsougungorncduS Qngoochlossen is attached. The bubble-generating module is connected to a respective hose line for supplying the cleaning liquid and the gas. In the biofiltering module, the cleaning fluid produced by the cleaning liquid-gas-bubble mixture is produced from the cleaning fluid supplied in a hose line and the likewise supplied gas. '' ·. , '.' .-. ' - '

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In a preferred embodiment, a partial flow is branched off from the stirred rectification solution and, for the purpose of carrying out a granulometric analysis, is diverted to a measuring point for determining the in the unused cleaning liquid

to abstain'Partikoi. '. .

On dor Untersoiio dos adapter there is another hole, however, runs with a uniform diameter, as a through hole also ends on the top of the adapter and there übargeht in another pipe socket with a Artschlußgowindo. Connected to this port is a hose line leading to a gas separator. After dom Gacabocheidor there is a branch in the hose line. A line of the branch leads to a sewer line, while the other line is connected to a measuring device for granulomstrischen measurement of entrained in the dirty cleaning liquid particles. The existing measuring device is connected to known devices for the csöktronischen Meßwertverarbeitung in which the catheter-induced particle emission is determined by comparison.

In the following, the operation of erfindungsgomäßsn device is shown.

The adapter is connected to the already shown supply and supply connections.

Into the homebuilder.g au? The underside of the adapter is inserted into the Ketetor® tube up to a noticeable adhesion.

The now adhering to the adapter catheter is completely inserted into the provided flushing tube and the adapter sealing in

the flushing pipe is pressed. .

The flushing pipe is closed with the stopper. To clean the catheter is now the cleaning fluid and the gas

fed in dia connections of the bubble generation module. -,

The cryogenic gas cleaning fluid-gas-biases mixture is generated immediately above the pipe stub and then

pressed vertically into the catheter after tanning. '

It has been found that the pressure building up on the cathotorus sinus eusplcht to keep the catheter frictionally during cleaning. The spent cleaning medium flows continuously through the through-hole in the adapter.

Depending on the final state to be achieved, which is the result of the particles being charged in the dirty cleaning liquid, the supply of cleaning liquid is interrupted. The flush pipe is completely removed from residual cleaning liquid and removed from the plug. The gas flow is maintained during this time. Then the decoupling kit is pushed onto the lower end of the irrigation tube and the catheter is inserted into the pre-pouching bag by pushing the adapter vertically downwards with the push rod in the irrigation tube. Dor flowing down from the Kstheterlumen gas flow causes a Logostabilisieirung the catheter and inflation of the packaging bag, so that a non-contact insertion is possible. If the catheter is completely enveloped by the packaging bag, then both are locked together by their cbgojogon holders and the packaging bag.

Ausfüforungotos53js! Eä, <. - '·

The invention has been described below.

According to the present invention, the ancestor is to be packaged with a 3.3 mm diameter (10 Cherrior) and 600mm lung su roSnlgon with production, etching, and foreign dust contaminated Kathsterschlouch. For this purpose, it is used as Rainingsrnodium © in prepared pure-Turner-Luftblosert mixture.

For this purpose, particle-free RS and non-free-of-air, oil-free and dried air were produced in the previous Arboits tests. Dio size of the particles in the air is below the Zühlberoiciioa of the particles in the ultrapure water and is therefore not relevant.

The volumetric efficiency of the reservoir to storeroom is 1: 2.5, and the air bubbles are said to be very small. They are produced by drilling holes of 60 μm. Slide water temperature is 22 degrees and the applied pressure

in RoinstwQC "crsp3tchorist4bar.

With a throughput of 2.5l / min Rainstwaocer, the lumen and outer catheter are cleaned in a flushing tube, the Bodonöffnung is closed with a stopper until the Portiegeiobiragung has reached a predetermined limit.

After switching off the Wsssarzulaufes. Emptying the spout tube and removing c2ss plug from the rinse tube, a packaging boutel is plugged onto the bottom opening of the irrigation tube and the catheter abutting, but in the lumen

introduced reduced air pressure in the Verpsckungsboutel. .

The erfindungp @ om5S® device is intended to be subsequently attached to an Aucführungcboispiol, in the associated

Show drawings,

Fig. 1 is a sectional view of the device during cleaning of a cathotor; Fig. 2 is a sectional view of the device during packaging of the cleaned catheter.

Referring to Fig. T, the apparatus is booting to the adapter 1 'and the flushing pipe 2. The flushing pipe 2 is closed by a plug 13. Dor stopper 13 is provided with a drain 14, which closes the valve by dpa valve 15. The valve 15 may be opened or closed depending on the method of cleaning and packaging knob lights. The adapter 1 site in the Snnsron of Spülrohros Si The seal is effected by the Dtchkring 3.

At the Untorcostodcs adapters 1, the receiving bore 4 is provided, in which the catheter 11 was inserted with hisam proximal end with slight constriction. The receiving hole 4 is connected to the pipe socket 6 via the bore 5. Era dor drawing, the diameter of the receiving bore 4 was shown on a larger scale than the other tests dor device. .''_ ' ^: . '/

According to FIG. 1, the oufberosictQ Rcinstwaosor-Lufiblassn-Gemäccäi siis enters a SiasenoaQugungsmodul not shown in the pipe socket 0 in the arrow direction. The supply of Reirioiwsscar and Storiitufi to the Bksenerzeugungsmodul takes place via separate Schlauchieitungen. In eirsar preferred execution is in the Reinstwaacor leading hose line

Abiwoig ongoordnst, wool in the ebgoiltigten line elna measuring device for detecting in the unused r.oinstwasspr mitßoführton dirt particles is present.

From the pipe socket 6, the cleaning medium flows through the bore 5 and the lumen 12 of the catheter 11 and occurs at the bottom of dom Lumtjn 12 in the flushing pipe 2 over. In the flushing pipe 2 of the Relnlgungsmodlüm is guided vertically upwards and then derived by dia Durchgsngsbohrung 8 from dtrn flushing pipe 2. For this purpose oino not shown hose line which is connected to Anschlußgawinda 10 dos Rohrstutsona 9 is used. In diceor hose is a gas separator and then oin branch; wherein the branched line a measuring device for Erfiäosung dor entrained in the water Schmutzpartiko! nactogaordnot is. In Fig. 2, the device according to the invention is shown during the packaging of the cleaned cathotar 11. Hiersu was first dao shown in Fig. 1 ® valve 15 is opened and the existing in the flushing pipe 2 Restwesserabgeloitet. Subsequently, the stopper 13 eua dam flushing pipe 2 was withdrawn. '.

According to Flg. 2, the floor insulation ISdosflülrohrea 2 was pushed on a box. Dar catheter 11 bofindötöt still indor Anahmenahhrung 4. lh the lumen 12 is in the direction of arrow oin air stream, which causes a drying dos'Cathetore 11 and boim inserting the catheter 11 in the Vorpackungcboutsl 16 a position stabilization of Vorsckungobeutols 16. This avoids the mutual sticking of the khothotor 11 and packaging bag 16 during packaging. The catheter 11 is inserted completely into the packaging bag 16 by means of an injection device 1 inside the flushing tube 2, vertically downward. Serves for this purpose pushrod 17, which is attached to the top of the adapter 1 and ihro Hubbetwegung by © inom not darnoctolitan machine element, for example, receives a Mydrauükkolbsn. Dio push rod is shown in Fig. 1. The air leaves after insertion of the catheter 11 in the Ver'packungsboutel 16 the cavity formed via dia through hole. 8

Finally, packaging bag 16 and catheter 11 were withdrawn together from the device and the VerpackungcbQutel 1 S closed.

Considerable documents:. '. , , '

DE-OS 3338C91 : '. · '' -.

DE-OS 3638749 DE-PS 3819257

Claims (9)

An ancestor for cleaning and packaging of catheters, wherein the lumen of the catheter is flushed under pressure with a liquid cleaning medium, at the same time the outer surface of the catheter is cleaned, in which then the catheter lumen is dried by a blown gas stream and wherein the Catheter is inserted into a packaging bag, dsdurcSvgokoransoiclhinot, that the cleaning medium, consisting of a mixture of a volumänioil cleaning fluid and oln to five volumes of gas bubbles, with a pressure of 0.3 to 0.6JVIPa into the lumen (12) ctes Kathetars (11) is pressed in, the vertical! is suspended in a flushing pipe (2), the bottom opening (18) of which is closed with a plug (13) so that the cleaning medium is still flowing vertically upwards, thereby cleaning the outer surface of the catheter (11) and then discharged into the wastewater, that after cleaning the flushing tube (2) emptied and the plug is removed and the bottom opening (18) of the packaging bag (16) is plugged into the catheter (11) with simultaneous injection of a gas stream in the lumen (12) is inserted. 2. A method according to claim 1, wherein the cleaning medium is made of a mixture of ultrapure water and sterile air. 3. The method according to claim 1, characterized golkairaraeleteot ,, that when used combustible  "Cleaning fluids are used as gas an inert gas. 4. The method according to claim .1 to 3, characterized g © k © ii5i2G5cto <3t that the cleaning liquid is a disinfecting center! is added. ., · '- 5. The method according to claim 1 to 4, characterized sokorarasoiamoi that the change from one cleaning liquid to another or di © completion of the cleaning process takes place when measured in the Rsinigungsflüssigkeit Partikelabtragung has reached a predetermined limit. , -. , '' - '.' 6. Device zpr Implementation of the method according to claim .1 to 5, characterized goko5Tinsc5cfäno4, dass.in a flushing pipe (2), the bottom opening (18) is closed with a plug (13), by means of roofing ring (3) axially displaceable adapter ( 1) is arranged, at the Untorsoäts © in the receiving bore (4) is present, dio via © ine bore (5) with a pipe socket (6) is connected, that on the underside still osne through hole (8) is vorhsnden on dor Top of the adapter (1) merges into a pipe socket (9) and that the adapter (1) on a push rod (17) attached est. . 7. Device according to claim 6, characterized g © Ei © nR2 © kGiffi © t _f that at the connecting thread (7) of the pipe socket (6) a bubble generation module is connected and that in the, cleaning liquid leading to the bubble generation module hose a branch is arranged and in the branched line a measuring device for detecting the entrained in the unused cleaning liquid dirt particles is present. 8. Device according to claim 6 and 7, dadwefo goEtoiisraoIchnot that the diameter of the receiving bore (4) is smaller by 5 to 20%, than the outer diameter of the to be cleaned Catheter (11). ' , -. , - '' / ' . _; 9. Device according to claim 6 to 8, characterized gokoiTDiniseSeSuffaQt that in the AnschlußgGwind © (10) of the-Rohrstutzens (9) angoschlossonon hose a gas separator and then a branch is arranged, wherein the branched line a measuring device for detecting d © r in the cleaning liquid entrained dirt particles is arranged downstream.