DE2208314A1 - Sterile surgical gloves - Google Patents

Description

PATENT LAWYERS

DR. I. MAAS

DR. F. VOITHENLEITNER
MUNICH 40

SCHLEISSHElMcR STR. 299-UL 3592201 / 2Q5

AMERICAN CYANAMID COMPANY Wayne, New Jersey, V.St.A.

Sterile surgical gloves

The invention relates to natural or synthetic rubber Manufactured products intended for use in surgical interventions, e.g. surgical gloves, which are or can be lubricated by dusting with a biodegradable powder. For years Powders of various kinds are used for dusting in surgical gloves, and the main task this powder is to make it easier for those working in an operating room to put their hands in natural or Synthetic rubber or latex-made gloves, such as those worn during surgical procedures will.

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It is desirable that the powder used on such articles, e.g., gloves, be non-toxic to living tissue and that it be biodegradable, i.e., ingestible by living tissue. To these qualities comes one of great importance because it is practically unavoidable during operations that parts of the powder from the gloved Hands of the surgeon are rubbed off or fall down and get into an exposed body opening; Furthermore, particles of such a powder from other areas of the operating room by air currents in an exposed Body orifice are introduced. Furthermore, the powder should not cause adverse effects in the patient's body, e.g. cause lesions such as adhesions, granulomas or the like, and the powder used on the gloves must be sterilized using clinical procedures leave, preferably both in the autoclave and by treatment with gaseous ethylene oxide. Furthermore, it must Powder have sufficient lubricity that the user of a surgical glove can easily put his hands in the gloves can insert, its particles must be sufficiently small, and the particles must have such properties as that they have the required lubricity. Finally, the powder must be available at a reasonable price and be easy to obtain; also, the powder must not be allowed to reach the surgeon, the auxiliary staff or the patient Cause skin irritation.

Talc was one of the first powders to be used by doctors in conjunction with surgical gloves. However, after talc was found to induce granulomas in the body, the use of talc as a powder for dusting gloves was quickly abandoned. The talc was replaced by starch powder because it was known that starch was biodegradable and because it was assumed that starch did not cause granules or other serious disturbances in the body. Currently, large-scale trade is a

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A common powder used for dusting surgical gloves, which is a specially "treated homogeneous amylose containing about 2 ^a / o magnesium oxide to prevent the formation of lumps.

However, starch-based powders have various disadvantages. The powders are very difficult to pour: and they tend to gelatinize in the presence of hot water or agglutinating, so that it becomes difficult to sterilize in a steam autoclave. Usually the starch must be treated in some way to remove these properties as much as possible. For example you can test the strength with a gown, e.g. epichlorohydrin, treat, as the strength is partially etherified, not to ensure that the powder is free-flowing after sterilization with steam.

furthermore, starch forms an excellent breeding ground for practically all vegetative bacteria, e.g. various pathogenic Liikroorganisms, so that their use from the oem reason does not recommend.

Although starch and magnesium oxide have been reported to cause granulomas, this is in the medical field still uses starch as no improved substitute is available.

Of course, it is desirable to dust surgical gloves to have a powder available that is easily absorbed by living tissues without damaging them Interactions occur, but so far there is no powder meeting these requirements of medical practice known.

According to the invention it has now been found that the above-mentioned requirements can be met by that one made from natural or synthetic chewing school Product for surgical purposes, e.g. a surgical

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glove »with an upper pull that causes lubrication a powder which consists of a polymer of glycolic acid and is hereinafter referred to as "glycolic acid polymer" referred to as. The glycolic acid polymer according to the invention is completely absorbed by living tissue within 90 days without any adverse effects being observed. As can be seen from Example 3 given below, the polyglycolic acid powder leads in the course of its biodegradation does not result in noticeable lesions such as adhesions or granulomas. According to example 2 to be explained a glove dusted with this powder can be sterilized in the autoclave without impairing the the desired properties of the powder, e.g. the flowability without the formation of lumps. Sas powder can also be sterilized using other known methods e.g. by sterilizing with gaseous ethylene oxide. The powder is non-toxic to living tissue, it does not lead to Skin irritation, and it is easy to manufacture synthetically.

There are also significant indications that the Applying the powder according to the invention to living tissue creates an environment that is bactericidal or bacteriostatic works. According to Example 4, which is yet to be explained, this emerges from the fact that wounds which have been intentionally infected with Staphylococcus aureus, without any signs of a Heal persistent infection if the wounds are also treated with the powder according to the invention. From the Example 5, still to be explained, this fact is further evident from the fact that aqueous suspensions of the powder are the Not sustaining growth of organisms like Staphylococcus aureus. It goes without saying that it is very desirable for To have a dusting powder available for medical purposes, which has a bacteriostatic and bactericidal effect at the same time. The polymerized glycolic acid used according to the invention can be produced using known polymerization processes used in the manufacture of sutures from polyglycolic acid and, for example, in the tJ.S.A. patent

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-5-3 297 033 are described.

Glycolic acid polymer can be used to produce a powder grind or otherwise pulverize until the desired particle size is achieved by using Grinding devices and grinding methods known type works. For example, the polymer can be in the form of fibers or put endless filaments in an ordinary ball mill and grind it for about 15 to 48 hours. The grinder is preferably earthed during the grinding process in order to prevent undesired agglomeration of particles, otherwise it would be caused by the static electricity that builds up on the grinder during the grinding process Particles can accumulate. The ground material can then be removed from the mill and passed through a set of vibrating screens of different mesh sizes, which are arranged on a sieve shaker. When choosing a powder, which should be suitable as a lubricant, the particle size of the ground polymer plays an important role *.

It is desirable that all of the particles of the powder be small enough to fit a 100 mesh per inch (149 micron sieve the U.S.A. sieve row). However, small amounts of up to about 1 percent by weight may be present in the powder somewhat larger particles can be present without unduly impairing the lubricity of the polyglycolic acid powder will. It is preferred that all powder particles be placed on a 200 mesh per inch (74 micron sieve) sieve U.S.A. sieve row). When the powder is through this sieve completely happens, it is an indication that there are no particles larger than about 74 microns in size are.

When producing powder for dusting surgical gloves, it is just as important that the powder is not too fine-grained, so that as much as possible, excess powder cannot get into the surrounding area if the hands,

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Surgical gloves and other objects are dusted. As mentioned, on the other hand, the powder must not over-; moderate particle size, and it must not be any significant Contain quantities of unusually large particles, otherwise the powder would exert an undesirable abrasive effect on the skin of the hand when the powder is used will. A suitable particle size range is from about 0.5 to about 149 microns, and the preferred range is from about 10 to 20 microns.

Products for surgical purposes made from natural or synthetic rubber are used for a wide variety of purposes. The most commonly used product is believed to be rubber gloves such as those worn by surgeons and auxiliaries during surgery or when examining a patient. Other sterile products that are used in surgical interventions can be, for example, catheters or drainage tubes made of rubber, which are inserted into a wound in order to effect drainage during the healing process. Such drainage tubes are often removed once the healing process has progressed so far that there is no more discharge. Regardless of whether a product for surgical purposes, e.g. a drainage tube, is left in the patient's body for several days or whether it is a surgical glove that only comes into contact with the fresh tissue of a wound for a few minutes , there is a risk that parts of a powder present on the surface of the rubber product will get into the patient's body. When foreign objects come into contact with living tissue, it usually leads to harmful reactions. The extent of such reactions can vary within wide limits, but even if the reaction is minimal, it is desirable to avoid such reactions as far as possible. ^;

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To prevent rubber products or parts of such products, e.g. the coils of a rubber hose or the slits of a surgical glove are glued together, it is desirable to have the surfaces of the products to be coated with a fine-grained powder in order to produce a lubricating effect. Such a lubricating effect is Particularly necessary for surgical gloves so that the gloves can be put on easily.

Of course, it is very desirable that such a lubricating powder be used on the living tissue of the Does not irritate the patient in any way. It has been recognized that it is desirable to have a chemically neutral powder available that can be completely absorbed by the body, but none is available for medical purposes as yet Powder available that has the required lubricity and is completely absorbable by the body, with under under all circumstances there is a guarantee that only a minimal reaction of living tissues will be produced.

As mentioned, it has been shown that polyglycolic acid in the form of very fine particles gives the rubber the desired slipperiness verleins, and that polyglycolic acid, which has got into a wound, from living tissue within a medical one Weight points of an acceptable period of time apparently completely is recorded. When used as a suture, polyglycolic acid is drawn into normal muscle tissue fully absorbed in less than 90 days. Polyglycolic acid is found in surgical wounds regardless of whether the powder is for dusting a drainage tube left in the wound has been used or got into the wound from a glove, usually only present in small amounts, and Observations have shown that the material can no longer be detected in any way after an increase of less than 90 days leaves. Of course, only relatively small amounts of the powder are rubbed off from surgical gloves, so that they are in get the wound; if larger amounts are used for experimental purposes

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deliberately introduces the powder into a wound and closes the wound, however, it can be determined that the polyglycolic acid is absorbed, and that here the tissue reacts only to a minimal extent.

Because polyglycolic acid has a low pH value in its property as an acid, which is more harmful to growth Microorganisms is not favorable, the growth of microorganisms is at least partially prevented as long as until the acidic effect of the polyglycolic acid has been neutralized by contact with other substances.

In addition to surgical gloves, other products for surgical purposes are used on a large scale, however, the most important is the use of polyglycolic acid powder to dust the surfaces of surgical gloves Field of use. In view of this, the invention will now be described in more detail with respect to such gloves described, which are provided with a coating of polyglycolic acid to produce a lubricating effect.

Since the powdered polyglycolic acid used for dusting on the surface of rubber gloves and other rubber products does not need to have any particular mechanical strength and can even be somewhat elastic in practice, a mixed polymer of polyglycolic acid that contains small amounts of lactic acid can also be used, e.g. as a result of a Copolymerization of polyglycolic acid and lactic acid. Such copolymers are also referred to below by the term "glycolic acid polymers". A copolymer usually tends to be more elastic or to have rubber-like properties than a homopolymer. If maximum strength is required, homopolymers often prove to be extremely suitable, but with a powder of the type in question, in which the tensile strength is not decisive, good lubricity results if the powder is made from a copolymer

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It is also a powder for dusting gloves do not need to use the manufacturing process to achieve maximum tensile strength, which prove to be advantageous if polyglycolic acid is to be used as a suture material, because the powder for Dusting gloves is the most important characteristic of lubricity, and if a rubber glove is on its Surface has been dusted with a powder, can be easily applied, i.e. when the user puts his hand lightly can insert into such a glove, the glove sliding over the hand even if the hand is slightly damp is, and if the surgeon is given the same feeling of being used to it, the powder has done its job, of course it is necessary that the glove glides smoothly on the surface of the surgeon's skin so that the thin, membrane-like rubber material the sensitivity of the! fingers of the surgeon so that the surgeon can easily feel any object through the glove.

Polyglycolic acid in the form of sutures has tensile strength, which can withstand the comparison with the tensile strength of steel taking into account the dimensions and Comparable to alloy steel on the basis of weight, but if this material is used in surgical gloves is to be used as a lubricant, the strength requirements are so low that batches of polyglycolic acid, which do not meet the requirements for tensile strength in the case of sutures, pulverized and with in can be made into a glove dusting powder with satisfactory results in all respects.

When polyglycolic acid powder is sterilized in an environment in which water is present in considerable quantities, e.g. in an autoclave, it is important to put the powder in include packaging that is substantially impermeable to water or steam. Will this precaution not hit, the polymer will be hydrolyzed by water once a day

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so that it becomes rubbery and sticky. A special one A suitable waterproof packaging material is a laminate in the form of a film made from a polymeric ester of Ethylene glycol and terephthalic acid and polyethylene such as that described in U.S. Patent 2,949,181. If polyglycolic acid is packaged using a water-impermeable material of the type described above, Can it be sterilized in the autoclave, and in doing so, according to example 2 to be explained below, it retains the one Powder for medicinal purposes.

Powders for dusting gloves are used in a variety of ways in the medical field. Surgical gloves made of rubber are usually sold in pairs in a non-sterile state, with in an envelope One of the gloves comes with a pack filled with a dusting powder. Should use the gloves are sterilized together with the package containing the powder, usually in an autoclave. Of the The surgeon then opens the powder pack, which usually contains around 1.5 g of powder, and pours the powder onto his hands. After the surgeon has distributed the powder on all the surfaces of his hands, he guides his hands that have been provided with the powder into the surgical gloves, whereby the powder acts as a lubricant and makes it easier to put on the gloves Reusable gloves are replaced by the gloves the completion of the operation washed, dried, examined for the presence of holes and then in preparation usually dusted with powder on both the inside and outside upon re-use. This dusting becomes common carried out in such a way that the gloves together with a prescribed amount of the powder in a rotatable Introduces the drum and keeps the drum moving for a period of time sufficient to cover the inner and outer surfaces to coat the gloves with the powder. Then the dusted gloves are packed again, sterilized in the autoclave.

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and handed over to the surgeon for further use. Since the powder often also adheres to the outer surfaces of the gloves, it is obvious that part of the powder should be applied to the surface verse from the gloves into a patient's surgical wound.

Surgical gloves, which are usually made of latex, are also available for medical purposes for single use only. Such gloves can be put on the market in pairs in connection with a pack of the dusting powder which is packaged in an appropriate manner. However, they are usually sold as pre-dusted gloves, ie the inside and outside surfaces of the gloves have been dusted with a powder before packaging. If the contents of the envelope, ie the gloves and the powder, are sterile, the entire envelope must first be sterilized in the autoclave or otherwise. When the operation is over, the gloves are thrown away.

The gloves of the invention can also be packaged in a tightly sealed peelable enclosure.

According to the above, the inventive Powder either separately in a packaging made of a suitable material or in connection with a product for surgical use or a pair of surgical gloves, sterile or non-sterile. That Powder itself can be both sterile and non-sterile. It can easily be in the autoclave or by treating with vapor Sterilize ethylene oxide and does not require lengthy pre-treatment to avoid the risk of clumping during sterilization.

If desired, sterile, dusted surgical gloves, a sterile powder or a sterile combination of surgical gloves and a separately packaged powder for dusting on the market, it is advisable to

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the sterile products in a sterile inner container which is then put into a sterile outer wrapper. The outer enclosure is made with provided with a peelable closure, which then makes it easy to present the sterile contents to the user, since it is only necessary to peel off the outer enclosure to reveal a completely sterile envelope, wherein both the outer surface of the inner wrapper and the contents are sterile so that the sterile contents are accessible to the user can be handed out. The user can then open the inner envelope and remove the sterile product from it without that there is a risk of contamination of the contents by touch with the outer surface of the inner envelope.

It is advisable to dust the gloves with polyglycolic acid in the form of very fine particles before the gloves sterilized, and the dusted gloves then sterilize and use them in a sterile state to be ready. It is also useful to apply the powdered polyglycolic acid in a sterile state to the surface in a more sterile manner To apply gloves at the time the gloves are put on. The timing of dusting the Gloves and the time of storage may vary according to the user's procedure and timing, e.g. clinic or individual surgeon. If sterile gloves are used, it is advisable to use them only once Use of certain so-called disposable gloves. If the gloves are to be used several times, the time at which the powder is applied and sterilization can be used can be varied according to the number of gloves to be kept ready at all times or according to other aspects.

The invention and advantageous details of the invention are explained in more detail below using exemplary embodiments.

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Example 1 - Preparation of a lubricious powder from Polyglycolic acid

Endless threads made of polyglycolic acid, e.g. U.S. Patent 3,297,033 were made in placed in a ball mill and milled for several hours. The milled product consisted of chopped pieces of thread with a width of about 0.050 to 0.100 mm and a length of about 0.305 to 0.508 mm. The particles were not cylindrical, but a flat shape and were frayed.

The ball milled product was then ball milled for 3 hours and then microscopically ground examined to see if further crushing had taken place. It became needle-shaped particles found varying in size from 0.5 microns to large pieces of the chopped endless filaments.

The product was then ball milled for an additional 15 hours. After this treatment happened a portion of more than $ 90 of the grist has a sieve with one Mesh size of about 178 microns and it has been found that most of the material has a particle size between less than 0.5 microns and 15 microns. The larger dimensions comprising material that passed through a 178 micron mesh screen, which was either acicular and had a diameter in the above range or it was due to static charges held together agglomerations. The powder retained by the 178 micron mesh screen was discarded.

Example 2 - Sterilizing Polyglycolic Acid Powder

The powder produced according to Example 1 was placed in a transparent envelope made of a laminate was made, which consisted of a polymeric ester of ethylene glycol and terephthalic acid and polyethylene. This laminate is suitable for both liquid and water

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impermeable even in the vapor state. In the laminate used, the polyester layer had a thickness of about 0.028 to 0.038 mm and the polyethylene layer a thickness of about 0.076 to 0.089 mm. The polyethylene layer of the laminate forms the inner surface of the package to facilitate heat sealing of the packages.

The pack was then heat-sealed into an autoclave of the usual design and exposed to ^{a vapor pressure of approximately 1.05 atmospheres and a temperature of approximately 121 ° C.} The pack was then removed from the autoclave and opened. The contents of the pack were found to be free-flowing and showed no signs of stickiness. The powder was applied to the hands of a subject who then donned two rubber surgical gloves. The effect of the powder in making it easier to insert the hands into the gloves was quite satisfactory. When the gloves were worn for a long time, it was found that the powder did not cause skin irritation.

Example 3 - Comparative Study of the Lesion Creation Properties of Starch and Polyglycolic Acid / Tb Dust Powder of living beings

In two female New Zealand albino rabbits, incisions were made in the peritoneum wall on either side. On one side, a 5 percent sterile saline solution with polyglycolic acid powder according to Example 1 was applied to the peritoneum wall upset. On the other hand, a corresponding solution has been widely used commercially Starch powder applied.

The rabbits were sacrificed after three months, and the peritoneum wall was examined general and histologically for the presence Any lesions examined, and the existing lesions examined separately. The part of the peritoneum wall who had been treated with the polyglycolic acid powder, apart from the presence of a few small, nodular granulomas, essentially free of lesions. The one with the strength

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Powder-treated rope of the peritoneum wall, on the other hand, had numerous immediately noticeable lesions and contained numerous several G-ranulomas and a large adhesion point.

These experimental results show that the formation of lesions is to be expected to a lesser extent if instead of the currently used starch powder, the polyglycolic acid powder according to the invention is used.

Example 4 - Investigation of the bacteriostatic and bactericidal properties of polyglycolic acid powder on living things

Two ventral incisions were made in two female New Zealand albino rabbits and both incisions were made intentionally infected with Staphylococcus aureus. Sterile polyglycolic acid powder prepared according to Example 2 was applied to one of the viunds while no powder was applied to the other wound. Both wounds were then sewn. After 7 days of healing, the wound treated with the polyglycolic acid powder did not show any signs infection, and the wound appeared to have healed properly. Examination of the untreated wound showed against it immediately that this wound was still badly infected.

These results indicate that the polyglycolic acid powder appears to be bacteriostatic and bactericidal in living things Properties shows.

Example 5 - In Vitro Study of Bacteriostatic and bactericidal properties of polyglycolic acid powder

Polyglycolic acid powder produced according to Example 1 wurae added in an amount of 4 g to an amount of water of 80 cm. The pH of the resulting suspension was slightly less than 2. A lot of this suspension became of 10 cm '' placed in a test tube labeled 1. The pH of the remaining amount of 70 cm ^ was reduced to 6 increased by adding about 0.3 g of sodium carbonate. One Amount of 10 cm ^ of the suspension with the pH value 6 was in a with 2 designated! test tube introduced. The pH of the

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remaining amount of 60 cnr was added to 7 by

3 increased by about 0.4 g of sodium bicarbonate. A lot of 10 cm with a pH of 7 was placed in a test tube labeled 3. Another test tube labeled 4 contained deionized water.

In each of the four test tubes an amount of 0.5 cm ^ of a 48 hour old suspension of Staphylococcus aureus in a broth was added. The test tubes were then incubated at 37 ^° C. for 24 hours.

An amount of 0.4 cm was then removed from each test tube and transferred onto cast agar-agar supports. This <
beer.

These plates were cast for 48 hours at 37 ⁰ C incubators

The results of this experiment are in the table below compiled.

Test tube pH result

No.

1 2 No growth

2 6 Moderate growth

3 7 Strong growth

4 - Strong growth

It can be seen from the above results that aqueous suspensions of polyglycolic acid powder have bacteriostatic and bactericidal properties in vitro. Of the acidic pH plays an important role in gloves or in a wound until it is increased, as in this case the environment is not favorable for numerous microorganisms.

Example 6 - Gloves dusted with powder

A set of freshly dipped gloves made of latex were placed in a drum together with about 1 g of the powder according to Example 1 per glove in the delivery state and before dusting. The gloves were rolled up and

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shaken until they are evenly coated with the powder after which the gloves were shaken to remove any excess powder. Me treated gloves were combined in pairs, folded and wrapped between two laminate sheets of polyester film and polyethylene arranged in accordance with U.S. Patent 2,949,181. The laminate was, as described in the said U.S.A. patent, Sealed by touching the surfaces made of polyethylene so that a lip and a tearable closure originated. A set of the wrapped gloves was then placed in an autoclave and brought to sterilization temperature heated.

The gloves produced and treated in this way could be accessed in a sterile state by removing the packaging and were then ready to use.

Example 7

A set of gloves that were 6 dusted according to the example with Polyglykolsäurepulver were between pieces of a laminate of the type described polyester and P _o lyäthylen sealed using a tear-open closure, and a set of gloves was placed in an ethylene oxide-containing chamber to allowing the ethylene oxide to enter the package through the seal point of the laminate, as described in U.S. Patent 2,917,878.

Expectations;

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Claims (6)

22083U AIS PACKAGES 1J product for use in surgical interventions, characterized in that the product consists of natural or synthetic rubber and on its surface a small amount, but sufficient to produce a lubricating effect, of a very fine particle forming, carries biodegradable powder made from a glycolic acid polymer. 2. Product according to claim 1, characterized in that the product is in the form of a surgical glove Has. 3. Product or glove according to claim 2, characterized in that the biodegradable powder consists essentially of polyglycolic acid having a particle size of 0.5 to 149 microns. 4. Glove according to claim 3 »characterized in that the glove is in the sterile state and in an inside sterile, strippable, off a laminate existing packaging is included. 5. ^v -g <** £ ühT »QTi _J γ» «η ft« hpi Λ PT »fiarm-hgiirig pjnp ° ° TJff * or synthetic rubber for surgical products Intervention enables the reactive living tissue To reduce to a minimum, as ^ Wrch indicated that a product made of rubber is used is, whose surface with ^ iner to achieve a lubricating effect sufficient quantity of a biodegradable Glycolic acid polymer in the form of very fine particles is. 6. worship according to claim 5, characterized in that g e k e η η ζ e i / Ch net that the product is a ORIGINAL INSPECTED 209837/0818