CS213645B1 - Medical bandage for wounds and method of making the same - Google Patents

Abstract

The present invention relates to the production of a medicinal wound dressing comprising a polyurethane foam wherein a non-compressed, open-celled original polyurethane soft foam material film with a thickness of 0.5 to 10mm. is softened on one surface, without thermal decomposition, up to stickiness and bonded to a polyurethane soft foam material film which has been completely irreversibly compressed 2 to 30 fold and with a thickness of 0.1 to 2 mm. in a gas- and water vapour-permeable manner, optionally followed by physical and/or chemical cleaning.

Description

When such dressing material is removed from the wounds for inspection and treatment, the wound or scab may be damaged, which disrupts or heals the wound process. even opens the wound again.

R813 845

For years, it has been sought to produce a dressing material from a completely sealed material, such as polyethylene. Such a dressing material provides a satisfactory environment for skin regeneration near the wound, but does not satisfactorily exudate the exudate, so that liquid is collected in the wound, which is undesirable.

According to DOS 2 103 590 a medical desert dressing for a dull desert to burn burns and the like is known, which consists of an upper layer of a neutral, thromboigenic, cross-linked foam material with open tubes and fastened thereon in the same direction, for gas-permeable, microporous backs - The front is made of mesh polyurethane soft foam and the back is made of polyolefin or polypropylene foil and both sides are connected to each other, for example with a gas-permeable adhesive - This wound dressing has the drawback that its manufacture is extremely costly due to the starting materials required according to the invention and the layer arrangement, and in particular the use of specially pretreated polyurethane soft foam plays an important role. Furthermore, the back of the wound dressing does not have sufficient mectaic strength to prevent agitation. p topically in medical use, so that local defense against bacteria is not ensured. Another drawback of this wound dressing is the perfect impermeability to the liquids, which makes it impossible to control the wound due to the abrasion of the wound without removing the wound dressing. This impermeability of the back side - the wound dressing for liquids leads to infinite wind. . collecting kappaine, which is an optimal healing process.

Further, according to DOS 248 813, an unreinforced polyurethane foam article is known for use as a coating material, wherein the foam tubes in the vicinity of at least one surface are partially collapsing relative to the foam tubes. the polyurethane foam article has a shortness when it is used as a dressing material, that it has neither a defined surface and open tubes, nor any original structure of the tubes of the starting material, nor does it exhibit a defined compacted surface with repeatable properties. stiff and dark enough to withstand the wound.

It does not guarantee any constant propuctivity for gas and water vapor over the entire surface and does not have a favorable protective effect against external wound infection. Furthermore, this medical dressing is not suitable as a temporary substitute for the treatment of 2nd and 3rd degree burns, ulcus cruris (leg ulcer) and other large-area skin defects, does not favorably affect the rapid formation of new capillary branches and - darkness. formation of enanthalantable skin base with uniform granulation growth, because the original cell structure is missing.

It is an object of the present invention to provide a versatile, inexpensive medical wound dressing, with good gas and water vapor permeability ^{, and} having sufficient protection against bacteria, having the desired mechanical and good mechanical properties. In particular, this medical wound dressing should be particularly suitable for the treatment of burns and similar injuries, while acting as a skin covering (temporary skin substitute) for oohana and treatment. It is another object of the present invention to provide an economical method for producing this many B13S

The wound medical dressing, in particular as a temporary skin replacement for large-area wounds, consisting of a face and back of a polyurethane soft foam, according to the invention, is characterized in that the wound face of the medical wound dressing facing the wound consists of open-cell, lyophilic, non-crosslinked, polyurethane soft foam having a foam thickness of 0.5 to 10 mm, preferably 1.2 to 2 mm and foam-pervious to it, foam-permeable and foam-permeable as well as conditionally liquid-permeable lyophilic backsheets for polyurethane foams 2 to 30 times mostly irreveirlably compacted, with a thickness of 0.1 to 2 mm, and an advantage of 0.3 already 0.6 mm wherein the backside tree exhibits an average apparent pore size of 3 x 10 ^- 8 to 8 x 10 - * mm.

The front and back sides of the medical wound dressing preferably consist of a polyether or polyester polyurethane soft foam having a spatial moisture content of 15 to 100 kg and a high proportion of residual cell walls.

In a preferred embodiment, the backings of the medical wound dressing average size influx W &pórů'3 x 10 "^ and ^f .. 8 x 10" ^ mm.

The principle of the method for the production of a medical wound dressing with a polyurethane soft foil foil as a face side and a densified backside of the polyurethane soft foam according to the invention is characterized in that it is generally 2 to 20 times, preferably 10 to 20 times irreversibly compacted after ^ <^! ^ i ^: s flexible polyurethane foam digested in tan ^Ké film having a thickness of O, ^{1 '0,} 4 mm, and these ^f Olie is SPOOO ^F OLIIA of uncompacted ^e pol ^y urethane soft "foam open-cell masses in the original state after foaming and a thickness of 0.6 to 10 mm, preferably 1.2 to 3 mm, permeable to gas and water vapor, wherein the uncompacted polyurethane soft foam sheet melts to the surface without thermal decomposition and then optionally carrying out physical and / or fire purification.

stickiness on povrota than ^h UTN Step ^{E: tert} original lie ^p ol ^y urethane 'p ^of line in a new soft material with open. pores and at the same time softening its surface is carried out by the breed in the temperature range from 500 to 700 ^° C. dwell time 0.05 to 0.6 s.

The generally irreversibly compacted polyurethane soft foam sheet is produced in a continuous manner and is generally split into irreversibly compacted polyurethane soft foam sheets having a width of up to 2,500 mm.

Irrevereibilně compacted foil flexible polyurethane foam is 'preferably compacted continuously from the flexible polyurethane foam of thickness 1 to 80 mm, s'50'mm preferably, two steel oozí ^p • teplctě ascomata at ^{200 F} and ²⁸⁰ DEG C., Vol ^{characterized} him ^d ou 23 ⁰ 0 at Dow delays 2 ^and 10 softening, preferably 3 minutes, and the compaction ratio of 2: 1 to 30: 1, preferably 10: 1 to 20 t 1 oboiustranně generally irrevereibilně and then continuously cleaved to film with a thickness of 0.1 to 2.0 mm, preferably 0.3 to 0.6 mm, in a width of up to 2500 mm. Preferably, the backsheet and the backsheet are substantially irreversibly compacted polyurethane foamed material with a thickness of 0, 2 to 0.6 mm and is used for another way of slaughter, so possible. - contamination and twisting cannot affect the He ^feed .

The polyurethane soft foam film usable according to the invention may be a polyurethane soft foam based on a polyester or polyether, preferably polyurethane soft foam β with a high proportion of residual cell walls. The space weight is

213 · 48 to 100 kg / ø ³ .

Preferably, a foam of the following composition is used as the polyester-based polyurethane soft foam of the following composition: 100.0 parts of a polyester alcohol for adipic acid, diol and triol quencher,

4.0 water

1.5 tertiary amine

44.0 toluylenedilisocyanate

The uncompacted, open-pored, polyurethane soft foam sheet forms the front side and the generally irreversibly compacted polyurethane soft foam sheet the back of the wound dressing made according to the invention.

The water permeability of the wound dressing made according to the invention is preferably about 120 g / n ² per 24 hours and the air permeability of the sine is preferably about 0.2 dm ³ . Pa ^_ ^ ² s ~ ^.

The wound dressing produced according to the invention is immunologically inactive, sterilizable ideally both with β-rays and ethylene oxide, and in autoclave for coloring without deteriorating properties.

The front side of the wound dressing produced according to the present invention with the original structure and open pips covers the wound surface and the largely irreversibly compacted layer acts in the presence of a fairly high proportion of residual cell walls with a labyrinth effect which guarantees an apparent average porosity of 3 x 10 x 10® "are preferably 4 x 10 ** ^ mm to 6 x 10" ^ mm sufficient blockade against bacteria invasion from outside, gas and water permeability necessary for the healing process, · regulates liquid management and can be specially locate excessive collection of secretion and exudate without removing the wound dressing of the invention.

Overcoming the unevenness of gas and water vapor permeability was initially a major problem in confirming such materials as a medical wound dressing in practical use. Surprisingly, it has now been found that, in contrast to materials compacted only from one side, which do not guarantee any uniformity of parameters, the inventive method can, with the largely irreversible compaction of normal original polyurethane foam sheets to a largely irreversibly compacted polyurethane foam sheet; following thinning, produce! hitherto unprocessable, porous foil and with degree of compaction, spatial weight of the starting foam and foil-dependent and precisely adjustable gas and water vapor permeability, which when combined with the non-densified foil of the original open-cell polyurethane soft foam will provide a medical wound dressing produced according to the invention, with said advantages over known bandages.

Moreover, it was unexpected that, despite the thermal load uncompacted origi- film ¹ 'tional flexible polyurethane foam having open-cell, not in the processing of the flame to achieve tackiness caused no adverse influence to be of therapeutic effect and can thus be used, this method effectively vysooe in contrast to non- joining with physiologically safe adhesives. This results in no toxic side effects. On the contrary, a medical wound dressing with better therapeutic properties than previously known products is obtained by the method according to the invention.

213 845 Examples

Example 1.

From a block of soft polyurethane foam and open pores based on polyester with a spatial weight of 42 kg / m and a width of 1500 mm. in a known manner, a 50 mm and a 2 mm thick strip of foam is now peeling.

The 50 mm thick foam strip is continually compacted irreversibly through the heated steel strips. Temperature ocelovýc ^hp Aesir others ^{No. 2} 5 ¹ ° C dote delay. 4 minutes and a compaction ratio of 17: 1. The compacted foam sheet is then cut into 0.3 mm thick sheets. The top and bottom layers are now smoked with a thickness of 0.4 mm and used for other purposes, so that any soiling or twisting cannot negatively affect the quality of the irreversibly compacted polyurethane foam.

Thereafter, the 2 mm thick open-cell compacted polyurethane foam sheet is guided together with an all-irreversibly compacted polyurethane foam sheet between the two rollers and joined, whereby the surface of the compacted polyurethane foam sheet with open tubes is facing on the facing side mostly irreversibly. pressed film flexible polyurethane foam softens without thermal decomposition POMC> CI flame te ^pl OTN between 5 ^m and ⁰⁰ °° ^≧ 7 °, ^and to achieve lepivost.Válce are Kons-tíruovány and ^'Z ^^ e pushes than íjnou foil polyure Yes in ^{t é é} rotary soft foam with ^t and ^p Evren ^yM OR ^y against largely irreversibly densified film of polyurethane soft foam hmty, wherein both foils extend equally quickly. The bandage is then wound up. The finished material with known methods divx into single-edged pieces, packaged and sterilized in a known manner.

Testing of the material produced according to Example 1 was carried out with an apparatus consisting of a gas burette of Д50 m ( _{f) of a} separating funnel (250 m) and of two tubes. Both tubes are identical to tubes C and D of the apparatus described under arsenic ion testing in the 2nd AB.-GDR. The difference in level between the level in the separating funnel and the zero point in the gas burette was 650 mm. The material to be tested was fixed by screwing both ends of the flat joint of the Ca D tubes.

Under these conditions, the following results were obtained: the blank test corresponded to the running time. liquids without maaerial charge 7 sec.

Pnrní cf. ⁿ Avaco hhdnota corresponded NDL ^ ^f orézníu irtru pore diameter. 2 x 10 “Dream = 32s.

Dr ^{in the} HA srovnávací- hhdnota corresponded mn ^ ^filt orézníu prtoěrem ru s ^to R 4 ^{s, 5} x 10 ^and Mn = 22 • eighth

The third &quot; swelling &quot; value corresponded to a multi-porous ^filter having a pore diameter of x x 20 ^А о = 15s.

Under these conditions, the "medical wound dressing produced according to the invention measured 20 's." Intersection ^{of Erny, p} Rumer apparent ^after RU was ohylboval ^{p p} roto at about ⁴ x ^{10 A} 9 mm. ^T ento. dia ^about ěr'l ^o · -zdán solid ductile pore diameter piů3obí'dostatečně inhibionš towards bakkerií ,. so make a wound dressing,. made according to the invention is particularly suitable for karats. typical images of wounds. as

- ^p o ^p álβoio stages 2 and 3. with or without previous surgical treatment

- ulcus cruris / leg ulcer / 1

- large-area skin and abrasion defects, or after surgical interventions;

213 64S “

Example 2. '

From the block of polyurethane soft foam with open tubes based on polyester β spatial - massosH 28 kg / m? Now zntaým manner uPA ^ ^é foamed strip material 40 mm thick and 2 'mm. The 40 mm thick foam strip is compacted irreversibly continuously between the heated steel strips. The temperature of the steel strips is. 258 ° C, dwell time 3.5 minutes - and a compaction ratio of 10: 1. A 0.5 mm-adhered film ^d and Hoima olní FC-eye layer was separated with -tlouš ^ cou 0.3 mm, and ^{- p} o ^u £ IV ^and for different purpose of use, so that any contaminants - and twisting can not be controlled! negative quality of irreversibly compacted polyurethane soft foam foil.

Then they are all irreversibly compacted! role after ^ URE ^ ^p new soft enoic ^s mass and nezhutntaá film flexible polyurethane foam with open pores connected together, is wound and - divided into pieces having fun in jednooiivé sterilized.

Testing mrVeriálu prepared according to Example 2, identical to the arrangement -probíhalo tests specified in Example - 1, keeping the blind in pokusu- three reference values and for postyyio prútolu liquid ¹ 4 s ^ at ^ zůanUvý reverse to the diameter ^after RU-TUD-ranges around 6 x ^{- 10} '? mm in still provides a sufficient proo! invasion of bacteria.

The medical wound dressing made according to the invention is suitable for the wound dressings exemplified

The medical wound dressing according to the invention has no total liquid cap, but it also allows the capillary effect of the generally compacted backside to increase the absorption of the exudate in the secretion in the wound without removing it! wound dressing detection of the exposed wound surface from the outside with respect to local βhr (lubrication or increased formation of wound secretion and exudate), as well as the decision to quickly change the dressing in part for optimum wound treatment.

Example 3.

From the block sl ^{p y s} ureevnsv ^PE soft materials with ^{newly -} opened! ^p ORY based potyesieru with - Just-Tor hmotano! 15 kg / m² n ^y it peels Zn ^ M ^ p ^≤ m zptoobem ^PE material with ^{newly-oušíkou 60} mm and 2 шш. The 60 mm thick sheet of material is compacted continuously with the steel strip being heated. Temperature is 237 - C _'t time - 4.3 minutes dwell and compaction ratio of 30 s - 1 · z ^ Thus tnfeý ^{Fr PE newly} mass - ^ i spurting then at 0.2 mm to standardize ^ NE.

The lower v-layer is now separated by 0.3 mm thickness for other purposes, so that any contamination in the torsion cannot be affected! The quality of the polyurethane soft foam can be reliably compacted.

Then - generally ^{i r, b} ILN ^of reversion from ^H UTN Step ^A ^ Ile ^PE soft polyurethane nov. ^The polyesters together with the non-densified film of the open-pored polyurethane soft foam according to Example 1 are rolled up. in individual pieces, - packs in sterilized.

Zkpuuení maVeelált prepared according to Example 3 was carried out by appropriately ordering the tests shall cause Example 1 Secondary messenger, ztónl ^ y diameter ^after RU ^5, 8 x Ю '^ шш fits in is equal to ^ RVN dressings listed in the Example 1.

Example 4. _w .

From a block of polyurethane soft foam with open cavities n in polyester base with a weight of 100 kg / cm @ 3, two 2 mm thick sheets are now peeled in a known manner.

One of the two belts of the polyurethane soft foam is. compacted continuously by passing between heated, corrosion-resistant steel strips. The temperature of the steel strips is 248 ° C, the residence time is 6 minutes and the compaction ratio is 2: 1.

Sweat 'are all irreveribiloě densified film flexible polyurethane foam unites tlphifáe now at ¹ mm ^tert li: d ^h OEZ UTN ^E do not polyure Yes in ^{n s p} a soft ^mass to ěooVé ccording example. 1. The bandage is then sieved and cut into loose-width strips in a known manner. The dressing material according to the invention can be used as an elastic dressing at any distance and is particularly suitable as a bandage and for a varicose symptomatic complex.

Example 5.

From a block of polyurethane soft foam with. The open pores based on polyester with a spatial density of 30 kg / hr are peeled in known manner into two sheets of foam having a thickness of 10 mm and 30 mm. The 30 mm thick polyurethane foam sheet is generally irreversibly compacted continuously between the heated steel strips. The temperature of the steel strips is 254 ° C, the residence time

4.5 minutes and compaction ratio * 15: 1.

Subsequently, a compacted 2 mm thick polyurethane soft foam strip was broken down into two equally thick 1 mm thick sheets. A 1 mm thick, generally irreversibly compacted polyurethane soft foam sheet connects to a 10 mm thick surface of a foamed polyurethane foam, the compacted open-cell polyurethane soft foam sheet of Example 1, then expanded and expanded in a known manner. belts volo optional width. The dressing material according to the invention can be used in any length as an elastic dressing and is particularly suitable for varicose ulcerative campes, wherein the dressing material can be used in any length. ideally supports the tail of the veins.

The material according to the invention can also be used successfully in the form of a composition.

Example 6.

From the block of soft polyurethane with open pores pěnové'hmoty OA polyester base with the spatial network hmon ^ 20 kg / m ^ ^p ou l.ou with a known 'method) ^f em Olle ¹⁰ mm and ^1, 5 mm.

The 10 mm thick polyurethane soft foam sheet is generally irreversibly compacted between two heated steel strips resistant to corrosion. The temperature of the steel strips is 257 ° C, the residence time is 4.6 minutes and the compaction ratio 5. ; 1. Afterwards, all the irreversibly compacted 2 mm thick polyurethane soft foam sheet without any treatment of the upper and lower covering surfaces is guided together with a non-compacted 1.2 mm thick, 2-roll open-ended polyurethane foam sheet with two rollers, following the procedure of Example 1.

The fabric obtained in accordance with the invention is cut in known manner into free-width belts and suitably used as an elastic bandage and shortens the high slip resistance.

213 · 645

Example 7. '

From a block of polyurethane soft foam with open pores and a density of 30 kg per h? · TE in a known manner in the rock band ^é foam material 50 mm thick, and is generally tantinuálnS irrevejriibiloě compacted between heated steel belts. The temperature of the steel strips is 252 ° 0, the residence time is 3.5 minutes, and the compaction ratio is 8: 1. Then it is generally irreversibly compacted. the polyurethane soft foam web is split into a 0.4 mm thick layer after removal of the top and bottom cover layers. irrevers ^Ibi Loe ^H UTN from Step ^{E: tert} Lie soft polyurethane enoic ^{p s} 0.8 mm thick material ·

The second block of flexible polyurethane foam · open-pore polyester base with ^ ostorávou hmotonobí 5 ° ^kg / m ³ Lou ^p e ^p ol ^y film ure't ANOVA ^E · ^s soft foam material 4 mm Si-LNA. 0.8 mm thick films generally irreveirsibilně compacted soft polyurethane foam w) connects with the rólH · ^ lyure tannic soft-enoic ^p · ^s mass with open ^p OR ^y · 4 mm sl ln ^{E =} ccording pfckladu · 1 · The bandage with known methods cut into strips of freely selectable width.

The dressing material according to the invention can be cut in any special purpose using lengths and used as elastic dressings with excellent healing effect.

Example 8.

Z ^b lo ^k u ^ lyuretanové soft foam ^é w> the open ^Pó bolt hole ^b aci ^p olye ester and having a spatial tamtono ^ 22 kg / m ³ · with ^Zn ° YM manner Lou ^Pa belt ^ new w) those in 36 mm thick, and ^k he ⁿ is generally compacted between heated steel strips. The temperature of the steel strips is 262 ° C, the residence time is 4.5 · minutes and · the ratio · compaction 12: 1.

Thereafter, the generally inversibly compacted polymer-based polyurethane foam sheet after breaking through the top and bottom covering layers at a thickness of 0.3 mm is split into an all-irreversibly compacted polyurethane-soft foam sheet having a thickness of 0.8 mm. The second block of a poly-tannic soft foam open cell polyester base with the spatial hmotnootí 80 kg / rn ³ Lou ^P e Tohei tol ^ re tannic Me ^kk é pfoové mass SZILI ^1, 5 mm and connects with altogether ir ^ a versatile compacted film of 0.8 mm thick polyurethane soft foam according to Example 1.

The resultant! According to the invention, the strips are cut in a freely selectable manner by known methods. This dressing material can be made-up in any special purpose of appropriate length, and is particularly suitable as elastic dressings since the very thin, non-compacted layer of open-cell soft foam prevents the individual wound layers from slipping together

Claims (6)

PREVIOUS C H E N G U R E Z U A medical wound dressing, grounded as a temporary skin substitute, for large-area wounds, consisting of a front and back side, a polyurethane soft foam, and a foamed himoy, characterized in that the front side of the medical wound dressing faces the wound. Consisting of open cell lyophilic uncrosslinked polyurethane soft foam, in its original state after foaming with a thickness of 0.5 to 10 mm, preferably 1.2 to 2 mm, and a deflector mounted on it 213 645 gas and water vapor permeable. and conditionally liquid-permeable lyophilic. the reverse side of the flexible polyurethane foam of 2 to 30tinásobně mostly irreversible compacted with a thickness ^{of 0.1 and} 2 mm ^{characterized} Vol him ou ^{d 0,} 3, ^{and 0.6} mm, ^{and the} holding ^of Tran backing has an average apparent size ^p ORU 3 x 1 ° ^and 8 ° x 10 ^-4л О. Second medical bandage ha wounds according to claim 1, characterized tml líoová and the reverse side * becomes a polyurethane soft foam'm thinking about those polyether-based or polyester and spatial bnotoootí ¹ 5-100 ^kg / rn ^P with high ^S hare residual cell walls . 3 »Medical wound dressing according to claim 1 including znn čuuící in that the reverse side has a mean apparent pore size 3 x 1 ^ ^{0, and} 8 x 1" ° mm. 4 · Zpíůsob producing a medical wound dressing with a film of flexible polyurethane foam "as the RS and compacted reverse side of 'soft polyurethane foam hmooy, v ^ ^j ^ i ^ ^s ^ C ^ UUI ^ i ^{^:} Í tm that is generally 2 to mutually 20tihátoboě preferably - 10 to 20tinasoboě irreversi ble-compacted porous flexible polyurethane foam cut into a thin film on tlou8 ^s CE ^{from 0,4} and ^0,1 mm, and they lie with ^tert drawbar with ^p ^ lK from Wipe Oaz ^{h é PE} soft polyurethane ^newly ĥ olty - with open pores in the original condition after foaming with a thickness of 0.6 to 10 mm, preferably 1.2 to 3 mm, permeable to gases and water vapor, wherein the film-compacted of polyurethane soft foam does not melt to the surface without thermal decomposition and then, if necessary, physical and / or chemical cleaning is carried out · 5 · The method according to item 4, which follows. - that the non-compacted original film. open-cell polyurethane soft foam is softened per surface with a flame in the temperature range of 500 to 700 ° C and with a dwell time of 0.05 to 0.6 s until tack is achieved · 6 · Zpiůsob according to claim 4, ^^ i ^ i ^ € ^ C ^^ ^ ear ^ ^c: d in that the compacted sheet toreversibilně generally flexible polyurethane foam is produced by continuous digestion irreveгsibiloě generally compacted soft polyurethane foam hmoO; y. widths up to 2,500 mm.