BLUTSTILLENDER SURGICAL FELT AND PROCEDURE FOR ITS PRODUCTION
The invention concerns blutstillenden surgical felt on basis of Polyglykolsäuren as well as a procedure for its production.
The problem of bleeding causes complications since generations with surgical interferences and after injuries. Different techniques were used for stopping the bleeding, like s laying of hot tar, reducing or tying bleeding containers on, used in more barbarian ages, the use of fuel iron, in order to burn the bleedings out, or the use of different clips, which are suitable for special surgical techniques. Also different federations were used, in order to favour coagulating the blood or to bring the bloodstream in other way to the stop. Different absorbable I0 of elements, which are to be brought to the wound with the surface in contact, was suggested, as for example foamed gel or worked oxidized regenerated cellulose. The history of the surgery shows many other materials, which were used for satisfying of bleedings.
Generally the desired characteristics of blutstillenden materials are well-known, although a constant need exists for new and improved blutstillende materials or Hämostatika. There is also fibers from synthetic polymers well-known, which can be absorbed by the fabric.
In particular the state of the art describes the use of Polyglykolsäure.
The US-PS Nr.3, 297.033 (Schmitt and Polistina, 10 January 1967, “Surgical Sutures”) describes absorbable seam, materials from Polyhydroxyessigsäureestern. The material is called also Polygiykolsäure and it indicated that small quantities of Comonomeren can be present, like DL lactic acid, the optically active forms of this substance as well as homologous and similar connections. The state of the art regards up to 15 as small quantities, which those the US-PS Nr.2, 608.162 (Lowe, 2.
February 1954, “Preparation OF High Molecular Weight Polyhydroxy Acetic ester”) clarifies.
In the US-PS Nr.3, 463.158 (Schmitt and Polistina, 26 August 1969, “Polyglycolic Acid Prosthetic DEVICE”) is descriptive and defined certain technical terms the surgical use of Polyglykolsäure.
The US-PS Nr.3, 620, 218 (Schmitt and Polistina, 16.November 1971, “Cylindrical Prosthetic DEVICE OF Polyglycolic Acid”) indicates a set of application purposes for Polyglykolsäure.
In the US-PS Nr.3, 736.646 (Schmitt and Epstein, 5 June 1973, “Method OF Attaching Surglcal Needles ton multi-filament Polyglycolic Acid Adsorbable Sutures”) is revealed surgical elements from a MischpoIFmerisat, which contains 15 to 85 mol glycol acid and 85 to 15 mol % lactic acid.
In the US-PS Nr.3, 739.773 (Schmitt and Polistina, 19 June 1973, “Polyglycolic Acid Prosthetic DEVICE”) becomes in particular bone pins, - plates, - nails and - screw from Polyglykolsäure stressed.
In the US-PS Nr.3 mentioned above, a set of US-PS is indicated 739.773, which is concerned with procedures for the production of Polyglykolsäure and the raw materials used for it.
In the above-mentioned US-PS Nr.3, 620.218 is in column 2 one. Series of medical applications of the Polyglykolsäuren enumerated, so in column 2, line of 52 worked or woven fiber products, including Velours, whereby in particular in line 53 fire federations are mentioned; in line of 57 felt or sponges for the StiUung of liver bleedings; in line of 63 absorbable sponges suitable for prosthetische purposes; and in the lines of 75 and 76 fire federations (in combination with other polymere foils and films).
In the US-PS Nr.3, a fibrous or fibrilliertes material is descriptive 783.093 (Sallacher, 1.Januar 1974, “Fibrous of polyethylenes of material”), whereby among other things Polyglykolsäure is specified, to whose production a resin is mixed with another and converted to fibers, according to which a 4S the resin under formation of a fabric from oriented, connected, arranged fiber-like strands, diaphragms, volumes, branched volumes and Fibrillen or fibers is out-lyed.
These materials can be used as bandages and for other medical purposes. In example 15 a product of 25 Teüen Polyglykolsäure and 75 parts polymethyl metacrylate is descriptive, which is leached out with acetone.
so the use of gauzes, felt and worked fabrics as Wundverbände is general practice.
Also the use of collagenartigen products was described as sponges or Kompressen.
Nr.343821 in the trade is available an oxidized regenerated cellulose as blutstillendes material. Further a gel foam product is in Blattform in the trade. These two products are absorbed by the fabric. Under certain circumstances the gel foam causes Gallenzysten. Preferably it is moistened at the time of the use with salt solution, whereby moistening with the salt solution, squeezing off, which renewed a moistening and renewed squeezing off is time-consuming and which make material smudgy flabby and in certain way, so that it at the instruments and the behandsehuhten fingers hitchhikers. Additionally the geschäurate gel possesses the inclination to pour in contact with blood and increase its volume. Also no suction effect can be caused by the foam through.
The oxidized cellulose can accept and at the gloves and the instruments stick a gel-like consistency. Since the material is worked, flakes of the material can spread when cutting.
It is far common to satisfy the bleeding of seeing CCIT wounds arisen when shaving thereby that one applies a small piece Toilettenpapier on the wound. If it concerns a small cut, the fabric at the skin adheres and satisfies the bleeding. The fabric is held by the Schorf, so that with the later distance in certain cases the wound begins to bleed again. Frequently the fabric on the accumulating blood swims, and other Maßnatunen becomes necessary the Sti] lung the bleeding.
From the DE-OS 2248813 the production of Verbandsteffen from polyurethan-foam is well-known. Before the treatment planned in the aforementioned German disclosure writing the foam exhibits a rubber surface, which non-absorbing is. This non-absorbing rubber surface is eliminated by use of warmth and pressure, as the cells are brought in the surface range of the foam to bursting, so that body fluid can penetrate the inside the burst cells.
The blutstillende surgical Fil2 according to invention differs from the aforementioned German disclosure writing admitted to dressing materials from polyurethan-foam according to the material, the obtained effect and the kind, in question, like this effect is reached, substantially. Blutstillende surgical felt according to invention on basis of Polyglykolsäuren is characterized in its nature thereby that felt consists of a coined/shaped fleece or a coined/shaped mat with a thickness from 0,26 to 0.29 mm and a weight per unit area within the range of 72,8 to 79.6 g/ra2 of statistically deposited Polyglykolsäurefasern.
Felt from statistically deposited fibers felt from verwobenen fibers can be differentiated easily, for example by visiting under a microscope from.
Those as federation of usable felt are according to invention from unverwobenen fibrous mat and/or such a fleece zus.rùrnengesetzt. The mat and/or the VHes is warm-EFF-coined/shaped, whereby a hämostatisches material with improved firmness and pliancy will receive. This distributes is received, without the permeability of the haemostatischen material is lost.
After a special execution form of the invention that exhibits blutstlllenden surgical felt screen end coined/shaped fleece or those blutstillenden surgical felt screen end mat Polyglykolsäurefasern with a titer between 0,5 and 12 that and a length from 0,64 to 7.6 cm.
Blutstillende surgical felt according to invention can be also received to forming procedures after that the subject of the invention thereby that one verspinnt a synthetic polymer absorbable of the fabric to fibers with a titer of 0,5 to 12, the fibers to segments with a length from at least 0.6 cm cuts, which deposit fibers statistically under education of a mat or a Verlieses with a weight per unit area from 72,8 to 79.6 g/m2, the mat or the fleece with a texturierten surface heated up consolidates and forms thus coined/shaped felt.
The fibers can be cut on a length from 0,64 to 7.6 cm and be converted by air deposit to felt.
In the context of the procedure according to invention it is also possible to use and individual blutstillenden felt with ethylen oxide sterilize homopolymere Polyglykolsäurefasern and drying in mikrobenund dampproof packing to pack.
Blutstillende surgical felt according to invention exhibits at least one surface, which was consolidated under heat effect. Consolidating and heat coining/shaping promote a stopping of blutstillenden surgical felt at the surface of the wound, so that the bleeding is normally stopped in effective way, since felt adheres firmly due to its KapiUarkräfte. If a large blood vessel is injured, the blutstillende sponge can be away-washed by the surface of the wound, although with a multiplicity of measures, as the out operating of a part of the liver or with the neurosurgery, which is so large adhesion that the bleeding is presently/immediately stopped. Consolidated blutstillende felt is preferably so thick and so close that no blood withdraws from the s outside surface. Because of the absorbability of felt can blutsti! lende felt when locking the wound to be left on the spot, whereby an effective staunching of bleeding during the surgical treatment and later bleedings are reached are held on a minimum, whereby the material is absorbed easily by the living fabric, so that it is not necessary to remove the blutstillende material which could entail a renewed bleeding.
Blutstillende felt is formed by the statistic deposit by fibers, for example by air deposit, on which felt under heat effect is coined/shaped. Usually the fibers possess a titer of 0,5 to 12 that and a length of at least 0.64 cm, although cutting the continuous fibers simplifies a handling and the air deposit of felt on a length from 0,64 to 5.1 cm or 7.6 cm. The fabric received by air deposit can be felted then in more usually is way, by rubbing the material either nondirectionally or also with Widerhaken provided needles nadelt, whereby a connection of the fibers is caused with one another. After coining/shaping a mechanical felt formation can be used, is not however not necessary.
Even if the fiber deposit procedure or the Filzprozc causes cine certain orientation, consolidating felt leads to a sufficient strengthening in all directions, so that consolidated felt represents a good blutstillendes material.
While usual felt, as it is descriptive in the US-PS Nr.3, 620.218 indicated above, did not consolidate at least a certain staunching of bleeding caused, devoted, felted fibers felt, which can be abgeschwemmt by a bleeding surface and which is too porous. The normal texture of the Filzoberftäche has the consequence that felt is kept away because of the statistic arrangement of the fibers and the soft surface of the usual felt surface from the surface of the wound.
It was now shown that coining/shaping and consolidating the fibers on the surface affecting the fabric lead to that felt so near hitchhikers that it is held back at the wound, while consolidating the lying exposed surface decreases the inclination of the blood to through-hire by felt. Felt is thinner, which decreases the blood volume in the blutstillenden material, whereby the absorption takes place during the healing procedure faster. The absorbable felt fibers, which consist for example of Polyglykolsäure, are easily absorbed during the healing process, while solid blood lumps staying can represent a larger problem. It is desired from there that only minimum accumulations of blood or blood lump in the wound are formed, so that the absorption of the run blood takes place faster.
3s suitable materials, of which according to invention suitable the fibers can be made, cover Polyglykolsäure, Polymilchsäure, Poly (N-acetyl-D-glukosamin) u.dgl. the blutstillenden materials made according to invention of such synthetic fibers are conventional blutstillenden products, which are made of natural materials, as the commercial blutstillenden gel sponges and regenerated Oxydcellulosen blutstillenden, clearly superior.
The fibers can be absorbed by the living fabric, so that any fibers, which are present in the wound, without unfavorable effects are absorbed by the fabric.
Consolidated, absorbable felt according to invention can for nearly each Wundart, with which the skin broke through, and with the body fluids, in particular blood and serum, from the wound out-step, to be used. It is predominantly suitable as blutstillendes material for any bleeding 4s surfaces and is particularly adapted on working methods, with which consolidated blutstillende felt is included into a wound, where felt is absorbed during the healing process by the living fabric. Felt is likewise very effective for the treatment of wounds at the skin surface, whereby consolidated blutstillende felt is laid on on the skin surface and at least one part of felt by the wound be included can. It can be used also as sponge in such a way, in order to wipe liquids off of Gcwebeoberflächen, whereby the advantage results that any replaced and fibers brought into the wound are innocuous, since they are absorbed.
Consolidated felt must be flexible, so that it can adapt to that photo of the wound and must be sufficiently flexible, so that consolidated felt can move with the moving fabric.
In the case of a use as blutstillendes material the blood coagulates within the felt structure and can harden therein so that the characteristics of the run blood determine the flexibility of the attaching structure.
The fibers absortierbaren of the fabric, which can be used for the production of blutstillenden surgical felt, include those fibers, which sufficiently fast, i.e. within one period of less than about 90 days, by which fabrics are absorbed. Polymers, which are absorbed by a hydrolytic splitting of the glycol acid ester connections by the fabric, lead l0 to good results. Since the firmness of the fibers is not from particularly great importance, a substantial lactic acid containing is lVlischpolymerisat suitable as good blutstillendes material. Such polymers are descriptive in the US-PS Nr.3, 736.646 indicated above.
One receives a preferential fiber absorbable of the fabric from homopolymerer Polyglykolsäure, which described under other polymers in indicated above the Patentschrfften of Schmitt IS are, and which is used with economic success as surgical Nahtmaterlal. Since this material is used frequently as seam material, it was recognized by the health authorities authorized and by the medical experts as usable, so that in the following the indicated examples and the following description are concerned predominantly with fibers from this material, although it understands itself that also different fibers absorbable of the fabric can be used. For similar reasons places a Polyglykolsäuremischpolymerisat, which one by polymerizing a Glykolid/Laktid mixture (90/10), likewise prefers used material receives.
Since felt stands normally only under a minimum load, a form of the Polyglykolsäure, which a smaller exhibits firmness than the suitable the products for the seam materials, is for which blutstillenden felt completely satisfyingly, and the blutstillende effect is needed predominantly there during 2S of the operation, leads a Polyglykolsäure, which loses its firmness less within 24 h or, good results and during the healing process fast of the fabric is too much absorbed. After the bleeding is closed completely stopped and the wound, those is probably Unw for a renewed bleeding clearly decreased, whereby the brightening process after a length of time of only it unites few days so far progressed that bleedings do not represent no more problem so. For reasons of a sufficient safety quantity and a certain protection of the Wundoberfläche during a considerable period of the healing process it is desired that the firmness will maintain during at least some fewer days.
Because of the different product types and the variations of the individual representatives of a certain type of product and because of the differences of the characteristics of the fabrics, in which the bleeding SS is satisfied, the minimum and maximum absorption times can vary considerably. In order to be on the safe side, it is desired that blutstillende felt lies within a annelunbaren range. A material, which maintains and within 90 days is essentially completely absorbed a substantial portion of its firmness during at least 3 days, leads to extremely favourable results.
It is of importance that it concerns with the polymer absorbable of the fabric a material, which is not harmful for the living human fabric, and which to a fiber will versponnen can, which forms such a fine structure that the blood and other liquids moisten the material, however not fast by the material through-hires. The polymer must possess a sufficient firmness, in order to maintain the co-operation of blutstillenden felt during its 4S production and use. It should be absorbed, before it can work after the sound of the wound as foreign bodies.
In the two patent applications indicated above examples of such materials are specified.
Since the favorable characteristics of consolidated felt according to invention are predominant a function of the size, the form and the structure, the so homopolymeren Polygiykolsäurefasern described more exactly in the following examples can be replaced also by other materials absorbable of the fabric.
Polyglykolsäurefasern and their production are descriptive and in particular in the Patentschrlften indicated above in the patent specifications, which are specified in the US-PS Nr.3, 739.773 indicated above.
The Polyglykolsäure becomes be suitable-proves threads with a titer of approximately 0.5 to 12 per thread versponnen. Thinner threads are difficult to spiders, while thicker threads are more rigidly than desired, although there is a set of application purposes, with which thicker and thinner threads are suitable. Normally a titer of approximately 2 to 6 represents the compromise between the easy Verspinnbarkeit and the sufficient flexibility, necessary good per thread, for the education of good felt and is preferential from there. Aptitude way, however not necessarily, becomes a group from fibers to a strand versponnen. The strand can be heat treated gezwirnt or at least le falschdrahtge2wirnt and, in order to ripple/crinkle the yarn and texturieren, according to which it is preferably cut with application of usual cut techniques to pile fibers with a segment length from approximately 0.64 to approximately 7.6 cm.
Also different usual rippling/crinkling procedures can be used, how the upsetting rippling/crinkling procedure, a work Entwirk procedure or the use of rippling/crinkling gear wheels or one can use a Zweikompols more nentenfaser, the polymers with different molecular weights than components contain.
A ungekräuselte fiber results in needles, a usual felt education technology, good results after that.
The cut fibers are deposited by Aufstreuen or by air deposit to a non-woven cloth with a weight per unit area. The mats or fleeces can be converted with the help of usual Reiboder needle techniques to felt, whereby itself a three-dimensional structure out with one another versch] ungenen fibers result in, which lends its firmness to felt. The material can be also only coined/shaped under heat effect, in order to attain the appropriate firmness.
Felt is coined/shaped preferably on both sides, so that one receives less porous felt and a material, with which the fibers which are because of the surface into the structure is in-pressed.
Thereby that the fibers which are because of the surface are pressed into the structure, so that a 2s will receive smoother surface can coined/shaped felt, if it is brought with a Wundoberfläche in contact of the wound match the contour more closely and prevents thereby the formation of cavities, in which blood or other liquids can collect. Due to the capillary forces blutstillende felt is consulted to the wound and noted so firmly of the Wundoberfläche that it is not abgeschwemmt.
Coining/shaping knows be suitable-proves thereby to be reached that one a heated up, texturierte surface, for example a hot embossing roll, used, those, without causing a melting of the fibers, to the fibers a continuing coinage and a smooth, flat surface lends. At higher speeds higher temperatures of the embossing roll can be used. One obtains good results with a roller temperature of for instance 177°C a pressure of approximately 187.5 kg/cm contact distance of the rollers and a conveying speed of 4,6 m/min. One uses an embossing roll heated up from stainless steel and a nylon against roller.
Coining/shaping the fabric affecting surface leads too eincr verbcsserten adhesion at the fabric and an increase of the effective surface, which comes with the blood into contact. The blood can through-hire by coined/shaped blutstiilenden felt and accumulate on the free surface. If the free surface is likewise coined/shaped, this leads to a local increased density, which prevents the out penetrating of the blood from the free surface, so that only felt licgende between the two coined/shaped surfaces is filled with blood. Since only a minimum thickness of felt is filled with blood, the later absorption of the blood lump is accelerated. The material, like the homopolymere glycol acid, absorbable of the fabric, is absorbed with a such speed of 4s that the presence of this material in the wound does not cause complications. A grölBerer blood lump can entail a scar formation or a retarded absorption.
Although a restriction is not intended on it, it is appropriate to make felt according to invention of fibers which are used for surgical seam materials. The ultimate tensile strength of such fibers varies from approximately 1406 kg/cm2 up to over 7030 kg/cm2. There is also less strong fibers for than blutstillende materials used sponges suitably.
As blutstil] end to materials of used felt thereby are usually manufactured that one submits un ekräuselte fibers, how they are used for seam materials a Nadelbehandiung, although one can coin/shape felt, also without him to needles.
Nr.343821 the stiffness of felt can be determined with the help of the standard methods, which are indicated to federal test Method standard 191 in that by the 31.Dezember 1968, method 5206. With this method a test sample from a rectangular fabric with a length is presented by 15,24 cm and a width by 2,54 cm on a horizontal level and postponed on test conditions over the edge, until the end of the fabric up to an angle of 41 1/2° dropped under the place of the surface of the level. The material is tested under the standard conditions, which are indicated to federal test Method standard 191 in that. Also different test procedures can be used, whereby it is to be held that the relative stiffness of coined/shaped felt is opposite not coined/shaped felt one of the characteristics of satisfyingly coined/shaped blutstülenden felt.
I0 is not towards-ennobled if felt, but the Faservlles formed by air deposit is only used, is this material somewhat more flexibly than the towards-ennobled material, whereby felt is consolidated by coining/shaping under heat effect, to which either an embossing roll with lozenge sample or fabric sample is used, and a satisfying blutsti] lendes material results in.
Another measure for the effect of the heat coinage is the Luftdurchlässlgkeit. The air permeability appropriately with the help of the standard test for regulation air by] ässigkeit of Textflgeweben, which ASTM standard designation D 737-69 (S. October 1969) determines. With this method under standard conditions air with a pressure is blown by 1,27 cm water gauge by a nozzle, which exhibits a übHcherweise diameter of 6,985 cm, over which the fabric is smoothly spread, whereby the air flow speed is usually indicated in cubic meters of air per minute per square meter of fabrics for a difference of pressure by 1,27 cm water gauge. A Gurley Permeometer stands a device suitable for this test procedure and uses a protection ring, which prevents a withdrawing of Nebenluft by the edges of the fabric. As is indicated further down, the fabric coined/shaped under heat effect possesses a substantially smaller air by] ässigkeit than it exhibits felt before coining/shaping under heat effect.
Aptitude way, edoch not necessarily, possesses the embossing roll a multiplicity of small, rhombic recesses, so that the fabric with a group is coined/shaped by lines, which divide the surface of felt into rhombically raised ranges.
A further good embossing roll carries on the surface into for instance the sample of a fabric, so that finished felt shows the appearance of a fabric. Also different samples can be used.
SO the embossing effect of the pressure roller consists of it, ranges of different compression too devoted, which have a texture of the surface to the rim, which improve flexibility and cause an excellent controlling of the blood permeability.
As surgical material it is obviously desired, if a not condition that blutstillende felt is sterile at the time of its use. Felt can be sterilized with application $5 suitable sterilization yklus using ethylen oxide as sterilization means. If ethylen oxide is used for sterilizing, it is of advantage to dilute ethylen oxide with carbon dioxide or a chlorine fluorine alkane in a such extent that the sterilizing gas is not explosive. With appropriate performing the available also the radiation sterilisation or the heat sterilisation can be used.
For the purpose of storage stability it is desired that blutstillende felt is protected by atmosphere influences. In particular if blutstiUende felt exhibits hydrolyzable Poiyglykolesterbindungen, the connections can be hydrolyzed with open storage by the humidity existing in the area. Since the firmness requirements of felt lie comparatively low, a certain measure of the dismantling is justifiable, and there long lasting Festigkeitserfordelmisse of the 4s of fabric is not necessary, is still suitable surgical felt also if he is reduced in a such extent that the fibers absorbable of the fabric are absorbed in a comparatively short length of time, i.e. within a few days. Desirable way such conditions of support are used that blutstillende felt in a dry environment is kept, so that felt whether it is used now immediately after packing or after multiyear S0 storage, which possesses same characteristics and possesses from there predictable characteristics, as far as it concerns the treating surgeon.
A good Sterillsationsund storage method is that, like it for Polyglykolsäurenahtmaterialien to technical extent is used and in the US-PS Nr.3, 728.839 (Arthur Glick, 24.April 1973, “Storag Stable Surgically Adsorbable Polyglycolic Acid Products”) is descriptive. As in this state of the art it described the Polyglykolsäureprodukt bone drying in a dampproof covering is kept, into which the product is brought in the way that first a side is left open, according to which the material with diluted and not-explosive ethylen oxide is sterilized and dried while maintaining the sterility in the vacuum and locked the covering.
After the foil covering is hermetically locked, as it is indicated in this patent specification, blutstillende felt can be held for several years in a usable form while maintaining its characteristics during one tent duration by at least I0. Aptitude way, however not necessarily, can be brought in felt between two paper sheets or a simple folded paper sheet, so that felt is held during the storage and with the use by the surgeon in flat condition.
In the case of large sheets felt can be folded, although sheets with a size up to 10,16 x it be suitable-proves 15.24 cm into a so large covering is brought that the sheet can be kept flat. Wishing case can be brought several sheets into only one covering. Single sheets with the dimensions 10.16 x 15.24 cm possess a by surgery acceptable size, whereby felt is cut to the time of its use of the surgeon or a Assisenten on the desired GrSBe. For many surgical measures ledigüch individual sheet is necessary.
A double covering, as it is descriptive in the US-PS Nr.3, 728.839 indicated above, is well suitable and uses the techniques, which are usual for the packing of seam materials. The double covering makes a sterile handling for a locked covering possible, so that the surgeon or the assistant can open the internal covering within a sterile range.
Individual covering, like it in the US-PS Nr.3, 017.990 (Singerman, 23.Januar 1962, “sterile package For Surgical Fabric”) is descriptive, represents likewise an economical and effective packing.
Preferential polymers are those, which exhibit glycol acid ester connections, and which are characterized further by that they are reduced hydrolytically under education from not-toxic, absorbable components compatible with the fabric. Is preferential homopolymere Polyglykolsäurefasern with a titer from 0,5 to 12 that and a length from 0,64 to 7.6 cm. They can be manufactured thereby that one cuts the fibers to segments with a length of at least 0.64 cm, which deposit cut fibers statistically under education of a fleece or a mat with a Flächengewieht from 72,8 to 79.6 g/m2 and which fleece or the mat with a texturierten surface under education of coined/shaped felt consolidates. The fibers can to be converted by air deposit to the fleece and sterilized with ethylen oxide and the blutstillenden materials be able in (more drained) form in one mikrobenund dampproof container to be packed more bone-dryly.
The blutstillenden materials have a thickness from 0,26 to 0.29 mm. The thicknesses are determined using 210 g a weighing weight and to correspond to an average density of cloth of 76,2 g/m2 or to lie in a range from 72,8 to 79.6 g/m2.
The air permeability can vary substantially, although a Luftdurchlässigkelt from 1432 to 1453 represents cms air per minute per square meter with a pressure of 1,27 cm water gauge an optimum value.
Stiffness or flexibility can likewise vary within a wide range, although a stiffness, which is same or larger than with 1,27 cm not-supported an inclination of 41 1/2° material is acceptable.
According to a preferential manufacturing process wh'd a mat or a fleece with a width rollers heated up by 45,72 cm with a middle Flächengewieht of 76,2 g/mz between a group of passed through, which are for example heated up on the desired temperature (174 to 191°C for in such a way a polymer with a fusion point of 230°C) and the desired pressure exercises (for example 178.6 to 357.2 kg/cm). The mat and/or the fleece preferably becomes with a firm linear speed (for example 3.05 to 6.1 m/min hindurehgeführt by the group of rollers. Optimal conditions for a No. 343821 such polymer are with 177°C, 187.5 kg/cm and a speed of 4,6 m/min. One knows an upper chromium plating engraved steel roller, which inside a Hei2que] le exhibits, for the education of the embossing sample and one with nylon or in similar way covered lower roller for the admission of the Walzendrucks of the embossing roll to use. Around each side to coin/shape two passages of the fabric are necessary.
Alternatively one can use also a suitable pair of chromium plating, engraved Prägewalzen.
In this case one can use a conveying speed from 3,05 to 4.6 m/min, which heat rollers up on 149 to 163°C and use a minimum load of the upper roller. The weight of the roller alone could be already sufficient.
The following examples serve the further explanation of the invention.
B e i s p i e 1 1: One polymerizes Glykolid under formation of a polymer with an internal viscosity of approximately 1.05 and extrudes the material with use of the techniques under education, used by the manufacturers for the seam materials described above, of fibers with a titer of approximately 2 per thread. The endless threads are inserted on a length of 3,81 cm cut, into a blower fan, suspended in air and put down statistically on a paper sheet under formation of a material with an even weight per unit area by 76,2 g/m2. Felt is passed through under an embossing roll, which exhibits engraved lozenges with a distance of 2.38 mm. The Ffl is consolidated against a nylon against roller, whereby the embossing roll is operated at a temperature from 174 to 179°C a pressure of 187,5 kg/cm and a speed of 4,6 m/min. After the free surface of felt under the embossing roll is passed through, felt is turned, the supporting paper is removed and felt under the embossing roll is passed through again, in order to coin/shape the second side.
Before coining/shaping under heat effect the fibers are flexible and are inclined to set up itself so that the Fitz has a soft fusselige surface and the thickness is not assignable.
A ähn1 icher felt is passed through with the same speed under the application of the same printing conditions and the same temperature under an embossing roll with a fabric sample. This lends a sample, which resembles that of a fabric (burlap to the surface of felt).
Then felt is cut on the dimensions of approximately 7.6 x 12.7 cm and presented on a Pergaminblatt, which is then umgefaltet, in order to cover coined/shaped felt in such a manner that it overlaps felt at all edges something. In umgefalteten paper available felt then in somewhat larger covering from Fonenmaterial kind, as it is descriptive in the above-mentioned US-PS Nr.3, 728.839, brought in, on which the partial still open Hüne, which is so arranged that she can be closely locked with parallel catch clamps on the open side, into an ethylen oxide furnace is brought, which is evacuated and beschiekt with 12% ethylen oxide in 88% Dichlordifluormethan 3S, on which one lets the material stand during 2 h, the furnace again evacuated and in the vacuum leaves, until ethylen oxide and jegnche humidity traces are distant, on which one would bring the vacuum in through from dry nitrogen waives. Under maintenance of the sterility the Hüne is locked then at the open side, brought into a larger up-ricable covering and the intermediate area sterilized, so that one packed one doubly, absorbable surgical felt receives, which is ready for the use lagerstabfl and at any time. In this packing the material maintains seihe characteristics during at least some years and probably even still longer.
The investigations accomplished so far could not determine yet the end of the useful life span.
B e i s p i e 1 2: A fast, sighting investigation for a blutstfllendes material is the 4S Vena cava test " at the rabbit, with which an oblong cut with a length is caused by approximately 6.35 mm in the Vena cava a rabbit, on which the blutstinende material is presented on the opening and held with the finger of the surgeon during approximately 15 seconds, according to which the finger is taken off and the blutstinende material is in such a way examined whether it interrupts the bloodstream. The blutstillende material according to invention exists this test both with rhombic and fabric-like embossing sample.
Comparison example 1: Stiffness and air permeability of the blutstinenden material.
With application of the procedure of the method 5206 federal test of the Ylethod standard 191 sections of coined/shaped felt are examined, by presenting and is the far over end postponing them in such a way on the test equipment that the edge of the sample up to an angle of 41 1/2° drops. Fabric stiffness is indicated as half of the length, which over-hangs the sample, if it reaches an inclination of 41 1/2°.
In the case of the material of the example 1 stiffness results as follows:
With lozenge sample coined/shaped:
Horizontal (parallel to the passage by the coining machine) vertical (perpendicular to the run direction by the machine) with fabric sample coined/shaped:
Horizontal vertically Nichtgeprägtes fabric:
For a regulation too little rigidly.
2.67 cm 2.92 cm 3.43 cm 4.65 cm similar investigations are accomplished regarding the air permeability with the help of the ASTM method D-737-69. The results are indicated as cubic meters of air per minute per square meter for a difference of pressure of 1,27 cm water gauge:
With lozenge sample coined/shaped:
Weight per unit area = 76.2 g/m2 air permeability = 1432 m3 per minute per square meter of the fabric with a difference of pressure coined/shaped by 1,27 cm water gauge with fabric sample:
Weight per unit area = 76.2 g/m2 air permeability = 1453 m3 per minute per square meter of fabrics with a difference of pressure of 1,27 cm water gauge.
Nichtgeprägtes fabric:
Weight per unit area = 76.2 g/m2 air permeability = 3875 m3 per minute per square meter of fabrics with a difference of pressure of 1,27 cm water gauge.
Comparison example 2:
3s Leberektomie it are accomplished subtotale Leberektomien at altogether 15 white New Zealand rabbits of different sex with a weight by 2 to 3 kg. The operation runs as follows: The animals are betäubt by intravenous administration by Natriumpentobarbital. The belly is shaved and it is durchgefiihrt directly a transverserunning cut underneath the edge of rib, in order to open the liver. The right middle, the left middle and the left lateral edge of liver are identified and a stick one Penis-clip is fastened to everyone of the two or three sections as close as possible to the Hilus, according to which the appropriate liver section is cut off along the clip.
Then the clip is removed and the blood is let run, until either the bleeding stops automatically or the animal ended. If the animal survives after stopping the bleeding, the 4s abdominal wall is locked in usual way and the animal into the cage is returned. The animal is treated preventively intramuskulär with 1 ml penicillin and Dihydrostreptomycin.
In similar way groups of 10 rabbits with for instance the same weight and different sex with use of the Polyglykolsäure of containing blutstillenden material of example 1, a absortierbaren gel foam, a worked absortierbaren material are examined out so oxidized regenerated cellulose and seam material mats from 2/0 surgical chrome seam material. In each case 20 to 30% of the liver inferred, whereby the blutstillenden materials are cut on a size, slightly more largely is than the Schnittoberfläehe and with 2 or 3 Seichen with a 5/0-Nahtmaterial from Polyglykols ure fastened, which is led about 5 mm below the cut by the Parenchym and fastened with surgical knots to the top side of the material.
Then the clip is removed. The covered surface varied from animal to animal, amounts to however about 12 to 13 cmZ. In the case of the animals treated with the seam materials 2 or 3 seam material mats are applied parallel to the cut surface and interlocked with the belly surface of the liver sheet.
S the abdominal wall will become then with a 3/0-Nahtmaterial from Polyglykolsäure in usual way locked and the animals without further treatment into the cages returned.
Results:
From the animals, which are treated without blutstillende materials, end to 73% between 6 min and 12 h after the surgical treatment.
I0 in the case of the blutstillenden materials was the effectiveness in all groups in approximately similar. After removing the clip usually a slight out seeping of the blood takes place during a short time along the edges of the blutstillenden material. Hardly oozing the blood is to be determined by the material. Blutstillende felt from the Polyglykolsäure in contact with the blood shining through, changed however its appearance and his dimensions otherwise not. The gel foam pours and fills its cavities with blood. The oxidized regenerated Ceilulose becomes black and accepts a gel-like consistency.
The gel foam must be pressed out before with salt solution courageously, moistened again and again pressed out, which is time-consuming and which makes material flabby and paste-like, so that it sticks at the instruments and the gloves, the worked oxidized regenerated cellulose frays at the edges out and adheres likewise at the instruments and the gloves. The seam material mats are to be fastened with difficulty firmly enough, in order to prevent the bleeding, without the liver covering tears.
Results:
In the case blutstillendeu of felt from Polyglykolsäure no signs for an post office-operational 2s bleeding or unusual pathological findings are to be determined. The investigations show a slight fokale Infarzierung directly underneath the material, whereby certain parts of the blutstillenden material with Galle are angefärbt, although no signs for a peritoneum provoking can be determined by running out Galle. After 15 days the local necrosis dissolved on the whole, while the Polyglykolsäure shows a certain absorption.
After 30 days can be recognized only a very small quantity of the blutstillenden filter from the Polyglykolsäure, and no fabric provoking can be determined.
After 60 and 90 days the reaction is with exception of a thin fibrous coat in the operation place and it shows up negatively a regeneration of the liver.
One of the animals of the group did not wake up from the Betäubung any longer. It shows however no 3s bleeding in the operation place.
Under similar conditions the iraplantierte gel foam is filled after 3 days with blood and Galle and it shows up a slight Infarzierung underneath the implant. The reaction after 7 days is similarly, however more diffuse.
After 15 days a Fibroplasie in the operation place, ranges a fokalen of a necrosis and Gallenzysten show up. The gel foam is still to a large extent intact.
The gel foam is absorbed after approximately 30 days, although with one of the animals Gallenzysten and a Fibroplasie arise.
After 60 and 90 days the above findings cannot be determined any longer and it are a liver recovery to be observed. After 60 days partly absorbed lumps in the belly 4S of an animal and a Gallenzysten in the case of another animal can be determined. Two animals end at a lung congestion and a secondary edema due to an overdose of the Betäubungsmittels. No sign of an post office-operational bleeding lets itself determine.
Oxidized regenerated cellulose the findings after 3 days covers a slight local Infarzierung underneath the implant s0 and Blutldumpen beside the implantierten oxidized regenerated cellulose, which refers to an post office-operational bleeding by the material.
The reaction after? Is similar to days.
The findings during 15 days are similar to the findings after 3 and after 7 days. Can additional be determined in some cavities within the liver Entzündungsexudate, Fibroplasien and partly absorbed blood lumps. The oxidized regenerated cellulose is absorbed to approximately 50%. The findings after 30, 60 and 90 days are on the whole insignificant, with the difference that after 60 and 90 days in the animals traces of regenerated cellulose are.
Blutstillende Naht_materialien in the case of the seam materials result after 3 days heavy Leberinfarzierungen, which surround the Nahtmateriatmatten, whereby after 7 days similar findings can be determined. After 15 to 90 days a progressive improvement of the above findings results. An animal ends on the fourth day for a technical reason, which does not have to do anything with the liver damage. A further animal ended on the first day and shows large blood lumps to the liver and generally speaking belly blood serum liquid.
It is to be seen that with a mortality of 73% due to the liver damage with the untreated depths in the case with blutstiilenden felt on Polyglykolsäure or the gel foam or the regenerated oxide cellulose, no animal ends itself to the treatment due to of bleedings.
Coined/shaped felt from the Polygiykolsäurefaservlies is superior to the conventional materials with the treatment. When using coined/shaped felt from the Polyglykolsäurefaservlies no post office-operational bleedings result.
Coined/shaped felt from the Polyglykolsäurefaservlies sticks not at instruments or gloves, maintains its co-operation better and can in damp condition, without tearing up and stick without at the instruments, to be handled, manipulated and hinund moved and is substantially better suitable from there for the use. The material is so rigid that it can be sewn gewünschtenfalls and used as pads.
B e i s p i e 1 3: Samples of coined/shaped blutstillenden felt from Polyglykolsäure are examined with neurosurgical operations of the brains of the test animals. Small pieces of blutstillenden felt are presented on the surfaces of the brain, on which a bleeding is to be determined, and held with the finger of the surgeon. A fine suction tube is used for the distance of the blood 2s, which seeps by the blutstillende material or around the blutstillende material. After a short length of time the bloodstream is completely brought to the stop, whereby a very small quantity blood is absorbed in blutstillenden felt, since it was removed by the suction effect.
During the operation measures flowing the blood into and around felt can be observed easily. If one uses a gel foam in contrast to it with the same purpose, then one must hold in usual way with the help of a Baumwolltampons on the spot, what makes the observation more difficult and the possibility disturbs the distance of the blood open that cotton stapels are included into the wound. After locking the wound results untcr leaving coined/shaped, blutstillenden felt from the PolFgiykolsäurefaservlies hardly a risk of a bleeding and the healing runs normally. The Autopsie does not show bleeding and a fast absorption 3S of the Polyglykolsäurefilzes in the animal and only a small influence on the sound of the wound.
In the Humanmedizin cause coined/shaped surgical felt according to invention from Polyglykolsäure in the case of brain injuries or other damages of the nerve tissue a good staunching of bleeding and make possible the recovery at least just as fast as the conventional surgical procedures.
The titer of the threads, the thickness of the felt sponge, the stiffness of the material and the handling characteristics can be varied with use of threads of different size, threads of different lengths and different temperatures and printing conditions during the embossing measures, so that felt with a thickness and a stiffness will receive can, which are particularly well suitable for a certain operation technology. Since different surgeons make different demands and it strongly varying surgical techniques give, with which a Blutstiliung is desired, can materials with different thickness and stiffness be manufactured.
Normally the material of the example I is sufficiently versatile, so that it is suitable for most operation techniques and fulfills the requirements of most surgeons and forms thus an effective blutstillendes material which can be used variously, which does not raise Lagerund of supply problems. Tissue absorbable synthetic polymeric fibers, such as polyglycolic acid, are felted to form a thin mat with at least one, and preferably both, surfaces compacted by contact with a heated embossing surface such as a hot roller. Porosity is reduced but the compacted felt retains its flexibility, and conforms readily to the surface of a bleeding wound to give effective rapid hemostasis. The hemostatic felt is conveniently but not necessarily allowed to remain in place during the healing process and is absorbed by living tissue. NR .343821 1. BlutstiUender surgical felt on basis of Polyglykolsäuren, D A D u r C h g e k e n n - z e i C h n e t, which felt consists of a coined/shaped fleece or a coined/shaped mat with a thickness from 0,26 to 0.29 mm and a Flächcngewicht within the range of 72,8 to 79 6 g/m2 of statistically deposited Polyglykolsäurefasern. 2. Felt according to requirement 1, D A D u r C h g e k e n n z egg C h n e t that the coined/shaped fleece or the coined/shaped mat exhibits forming Polyglykolsäurefasern a titer between 0,5 and 12 that and a length from 0,64 to 7.6 cm. 3. Procedure for the production of blutstiUenden surgical felt according to requirement 1 or 2, D A D u r C h g e k e n n z e i C h n e t that one verspinnt a synthetic polymer absorbable of the fabric to fibers with a titer of 0,5 to 12, the fibers to segments with a length of at least 0.6 cm cuts, which deposit fibers statistically under education of a mat or a fleece with a weight per unit area of 72, 8 to 79.6 g/m2, the mat or the VHes with a texturierten surface heated up consolidates and forms thus coined/shaped felt. 4. Procedure according to requirement 3, D A D u r C h g e k e n n z e i C h n e t that the fibers are cut on a length from 0,64 to 7 cm and converted by air deposit to felt.
B. Procedure according to requirement 4, D A D u r C h g e k e n n z e i C h n e t, which one uses homopolymere Polyglykolsäurefasern and which individual blutstillenden felt with ethylen oxide sterilized and drying in mikrobenund dampproof packing packs.
Pressure: Ing.E.Voytjech, Vienna