NL8005990A - PROTECTIVE AND SEALING MIXTURE FOR SURGICAL APPLIED DRAIN VENTS AND ARTICLES MADE THEREFROM. - Google Patents

Description

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VO 111T

Protective and sealing mixture for surgically arranged drain holes and articles made therefrom

Protective and sealing mixtures in the form of rings or sheets for applying round. surgically arranged fluid drain holes are lent. A common formulation for such blends includes a gelled mixture of karaya gam and glycerin (U.S. Pat. the karaya gam and glycerine-based sealing mixture is used in the form of a pre-formed ring, which is placed around the stoma between the gasket of the receptacle 10 and the wearer's body. The purpose of the ring is a protective seal provide, ie prevent the visceral fluid or urine discharged from the stem from leaking around the ring, so that all of the effluent is collected in the pouch protected therefor. The sealing ring also has the function of protecting the skin around the stoma against the irritating urine or visceral fluid, which in the case of a duodenum stoma may also contain gastric juices. The second patent mentioned above illustrates that the mixture of karaya gum and glycerine can also be used in the form of a sheet. Such sheets may also be used around ostomy openings, and may include as many as; described in U.S. Pat. No. 3,995-105 are used around drainage openings from a wound or surgical incision.

Sealing blends of the type described are preferably initially tacky (dry tack) so that they initially adhere to the skin around the drain opening. It is particularly important that the mixtures 25 maintain a high adhesion when in contact with an aqueous liquid. This is commonly referred to as "wet tack". The hydrocolloid in the mixture, such as karaya gum, absorbs water, causing the hydrocolloid to swell and increase stickiness. On continued exposure to the aqueous liquid, especially when that liquid is urine or a visceral liquid containing gastric juices, the mixture tends to decompose, lose its mechanical strength and eventually become ineffective for its intended function. In use, such sealing rings or sheets often need to be replaced ο η n 5 o o n -2-. It has long been desired to improve the mechanical and / or adhesive durability of such rings or sheets, but no satisfactory solution has so far been found.

The invention is partly based on the discovery that a new and surprising result is obtained by processing a small amount of colloidal silicon oxide, preferably in the form of "fumed" silicon oxide, in the protective sealing mixtures, consisting of a mixture of a hydrocolloid gum and a polyhydric alcohol. In particular, the resistance of such mixtures in the form of rings and / or sheets to degradation under the influence of visceral liquids and / or urine is considerably increased by incorporating only 0.2% "fumed" silica. At a concentration of silicon oxide of more than Ο.Ο wt.%, The wet tack of the mixture is reduced to such an extent that the mixture is no longer effective. However, by limiting the amount of silica incorporated into the mixture, the mechanical durability of the mixture can be increased without significantly reducing the wet tack, while also providing a satisfactory dry tack. The invention can be applied to protective sealing mixtures prepared from gelled mixtures of particles of hydro-colloid gamm and a liquid polyvalent alcohol which can be formed into rings or sheets and then stiffened by gelling. In addition to the usual use, the hydrocolloid gcm is preferably karaya gam, but other gellable hydrocolloid gams can also be used to replace all or part of the karaya gum. Examples of such gellable hydrocolloid rams are ghatti, zedou, tragacanth, gelatin, dextran, pectin, xanthan, and similar natural gums. Synthetic gums can also be used, including sodium carboxymethyl cellulose and hydroxyethyl cellulose. Such hydrocollold ganes are polysaccharides, which are hydrophilic and water absorbent, and are gellable in mixtures with glycerine or other polyhydric alcohols.

According to the invention, the hydrocolloid rams were used in the form of fine particles, for example powders. Karaya gum is usually used in sufficient form of particles smaller than 0.15 mm. The gamphers are used in an air-dry state, i.e. they feel dry to the touch, but may contain some moisture, for example 10-18 wt.%.

The main liquid component of the sealing mixture is 80 0599 0 ', preferably a non-toxic liquid polyhydric alcohol. Following conventional use, glycerine is preferably used, but other polyhydric alcohols with similar properties can also be used, eg propylene glycol, sorbitol, etc. Preferably, the polyhydric alcohol is not only non-toxic and non-irritating when applied to the skin but preferably it also has a softening or softening action, as is the case with glycerine and similar softening polyvalent alcohols.

In preparing the sealing mixture, a sufficient amount of the polyhydric alcohol is used to obtain a liquid mixture, which can be formed into the desired ring or sheet and then stiffened by gelling and gelling. The mutual ratio of the polyvalent alcohol and the hydrocolloid can be varied while still obtaining the above-mentioned results. If too small an amount of alcohol is present, the mixture will be too stiff to be poured into the mold, and if too much alcohol is present, the resulting mixture will be too soft and not gel enough. In line with current practice for mixtures of karaya gum and glycerine, good results are obtained with equal parts by weight of gum and alcohol. However, a moldable mixture can be obtained with more or less glycerol or with another polyvalent alcohol. Generally, the mixture may contain 35-55 wt% karayagcm or other hydrocolloid gum and additionally 35-55 wt% glycerol or other polyhydric alcohol. In particular, it is advantageous to prepare mixtures with 80-120 parts by weight glycerol / 100 parts by weight karayagcm.

According to the invention, colloidal silicon oxide is incorporated into the sealing mixture, which is preferably dispersed homogeneously therein.

Preferably "fumed" silicon oxide is used, although colloidal silica gel can also be used. The "fumed" silica is obtained by surface hydrolysis of silicon tetrachloride. It can be obtained from various manufacturers, including the "Cab-0-Sil" products of Cabot Corporation, Boston, Massachusetts, and the "Aerosil" products of Degussa, Inc. New York, NY, USA These products consist of colloidal silicon dioxide with a very large specific surface area. M-5 from Cab-0-Sil.

According to the invention, colloidal silicon oxide is incorporated into the mixture in an amount of 0.1 - 0.0 wt.% (This percentage and other percentages are based on the total weight of the mixture, including 8 5 5 β on -k-iri notion of the silica and all other components of the finished product). Within the said range, the resistance of the gel mixture upon contact with urine and / or visceral fluids is greatly improved, while the wet tack remains sufficient. Preferably, however, no more than 1.5 # of silicon oxide is used, for example 0.1-1.5 #, so that the dry adhesive and the wet adhesive are both more fully retained.

To the viscosity of. In order to reduce the mixture and to facilitate shaping, it has been found desirable to additionally include sodium carboxymethylcellulose (CMC) in the mixture. For example, one can use 2-15 # CMC 10. In. typical compositions, 3-8 parts by weight of CMC is combined with 50% by weight of karaya gum and 1 + 0-50 parts by weight of glycerine and 0.5-1.2 parts by weight of fumed silica. left aside, the optimum amount of silicon oxide is slightly smaller, for example 0.2-0.8 #, based on the mixture.

The mixtures may additionally contain minor amounts of other ingredients, such as preservative and bactericidal agents. For example, an alkyl 2-hydroxybebzoate or a mixture of such benzoates can be used as a preservative. For example, one can use a mixture of methyl, ethyl, propyl and butyl parabens. When parabens 20 are used, in amounts of, for example, 0.1-0.5%, it may be desirable to first dissolve the parabens in propylene glycol or another co-solvent in which the parabens dissolve better than in glycerin. For example, 2-10 parts of propylene glycol can be used per 100 parts of glycerine.

When combining the ingredients to prepare the moldable mixture, the parabens can first be dissolved in the small amount of propylene glycol and then the resulting solution of parabens mixed with the larger amount of glycerine. Subsequently, the "fumed" silicon oxide can be dispersed in these polyhydric alcohols until a uniform dispersion is obtained. Then, the hydrocolloidal gum in the form of powder is added and mixing is continued until the mixture is evenly mixed. The mixture is then molded before gelling, which can take place within 5-10 minutes. For molding, the mixture can be poured into ring or sheet molds and molded under desired pressure, for example, with a movable plate or top mold. During shaping, the mixture will quickly stiffen into a gel. If desired, the isolation can be accelerated by heating the mixture, either in the mold or after molding. For example, antiwave heating can be applied to the mixture in the form or the pre-formed rings or sheets through a tunnel with infrared heating. The heating temperature is not very critical, because the gelling also occurs and is completed at room temperature.

However, by heating the sheets or rings to 70-Ö2 ° C, the stiffening and gelling can be completed in a shorter time. There is usually no loss of the polyhydric alcohol during stiffening and therefore the mixture should not be heated to a temperature above the boiling point of the polyhydric alcohol.

Preferred embodiments of the invention and the results obtained therewith are illustrated by the following examples. Example I

A protective and sealing mixture is prepared according to the invention with the following formulation:

TABLE A

Ingredients Wt. $ (1) 2% fumed silica ^ in a glycerin mixture ^ 50.0 (h) (2) Karaya gum powder ^ -5.0 20 (3) Hatrium carboxymethylellulose (CMC) ^ 5.0 100.0 (a) This yields 1 fumed silica: Cah-0-Sil M-5 (Carbot Corporation, Boston, Massachusetts).

(b) <0.1 mm; 10-18 $ moisture.

(C) CMC 7H0X8F (Hercules, Incorporated, Wilmington, Delaware).

(d) Glycerin Mixture: 9, 795 $ glycerine, 839 $ propylene glycol, 0.161 $ methyl paraben, 0.028 $ propyl paraben, and 0.177 $ butyl paraben.

When the above components are combined, the glycerine mixture with the evenly dispersed silica therein is mixed with the powdered karayagcm and with the sodium carboxymethylcellulose until an evenly gellable mixture is obtained. Before gelling, the mixture is poured into molds to form rings or sheets and the mixture is stiffened in those shapes to obtain rings or sheet products. The stiffening can be accomplished by leaving the mixture in the molds overnight at room temperature. Stiffening can also be accelerated by applying heat - with an infrared lamp or by irradiation with microwaves. Microwave heating is preferably used.

In order to improve the dry tack, if desired, a small amount of a suitable pressure-sensitive adhesive can be applied to the bottom of the molds before those molds are filled with the mixture. This adhesive may be, for example, the "HU9" vinyl acrylic medical grade pressure sensitive adhesive. Adhesives, Chicago, Illinois, U.S.A.

Example II

In another embodiment, a protective and sealing mixture is prepared according to the invention having the following composition:

TABLE B

Components Wt% (1) Propylene Glycol (USP) 2.25 15 (2) Methyl Paraben 0.075 (3) Propyl Paraben 0.013 (U) Butyl Paraben 0.082 (5) Glycerin (USP, 99%) 46.58 (6) "Fumed" Silicon Oxide 0.50 20 (7) Karaya gum powder 50.50 100,000

When combining the above components, components 2-4, the parabens, are dissolved in component 1, and propylene glycol. This solution is added to the glycerine component 5 and mixed with hcmo-25. Then, component 6, the "fumed" silica, is dispersed in the liquid solution of the above components, and the dispersion is mixed until all is hydrogen. Component 7, the karaya gum, is then added with continuous stirring until an evenly gellable mixture is obtained. Before gelling, this mixture is poured into molds to form rings or sheets and it stiffens into rings or sheets in those molds. This stiffening can be achieved by leaving the mixture in the molds overnight at room temperature.

Here too, stiffening can be accelerated by supplying heat through infrared lamps or microwave irradiation.

In this example, Cab-O-Sil M-5 (Cabot Corporation, Boston, Massachusetts) was used as the silicon oxide. The karaya gum consists of a • powder with particles smaller than 0.1 mm and it can contain 10-18% moisture.

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Example III

A mixture is prepared as described in Example II except that an equal weight amount of algin powder is used instead of the karaya gum. The algin used was supplied by Kelco 5 Company, Clark, New Jersey.

Example IV

Using the procedure described in Example II, a protective and sealing mixture was prepared with the composition of Table C.

TABLE C

10 Components Wt. $ (1) Propylene glycol (üSP) 2.88 (2) Methylparaben 0.098

(3) Propylparaben 0.01T

(½) Butylparaben 0.105 .15 (5) Glycerin (USP, 99%) 56.4- (6) "fumed" silica 0.5 (7) Xanthan gum 40.0 100,000

In the above table, the xanthan gum is a food grade 20 supplied by Kelco Company, Clark, Few Jersey.

Example V

A protective and sealing mixture was prepared using the procedure of Example II and the composition of Table D.

TABLE D

25 Components Wt,% (1) Propylene Glycol (USP) 2.37 (2) Methyl Paraben 0.079 (3) Propyl Paraben 0.014 (1) Butyl Paraben 0.087 30 (5) Glycerin (USP, 99%) 46.45 (5A) Sorbitol ( USP, 70 $) 5.0 (6) "Fumed" silica 1.5 (7) Zedou gum powder 44.5 100,000 35 When mixing said components, components 5 and 5a, namely glycerine and sorbitol, were combined, as described for the glycerin component 5 in Example I.

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Example VI

A protective and sealing mixture was prepared using the procedure of Example II and the composition of Table E.

TABLE E

5 Components Wt% (1) Propylene Glycol (USP) 3.05 (2) Methyl Paraben 0.10 (3) Propyl Paraben 0.02 (K) Butyl Paraben 0.11 10 (5) Glycerin (USB, 99%) 59.72 (6) "Fumed" silicon oxide 2.0 (7) Hatrium carboxymethylcellulos e 35.0 100,000

The sodium carboxymethyl cellulose was CMC 7H0XF grade supplied by Hercules, Incorporated, Wilmington, Delaware. Also: here again, the formed rings or sheets were preferably stiffened with microwave heating.

Example VII

A protective and sealing mixture was prepared with the composition of Table F.

TABLE F

Components Gev% (l) Propylene glycol (USP) 2.71 (2) Methylparaben 0.09 25 (3) Propylparaben 0.020 (U) Butylparaben 0.1 (5) Glycerine (USP, 99%) 53.08 (6) Deionized water 3.0 (7) "Fumed" silica 1.0 30 (8) sodium carboxymethyl cellulose 15.0 (9) Karayagcm powder 25.0 100,000

When combining the above components, the same mixing procedure as in Example II was used for the Campaigns 1-5 referred to there. Component 6, the dis-distalized water, is then added and mixing is continued until an even mixture is obtained. Then, component 7, the silica, is dispersed in the liquid solution to form a uniform dispersion. Component 8, the sodium carboxyethyl cellulose, is then added with continuous stirring and finally component 9, the karaya gum, is added and the mixture is continued until a uniform gelling hair mixture is obtained. The shaping and gelling procedure is the same as described in Example II.

Example VIII

Durability and tack tests were performed using the composition below and with aliquots of silica (Cab-O-Sil M-5) ranging from 0-2.5% *

IA.BEL G

Components Qev.% (1) Propylene glycol (USP) 0.735 15 (2) Methylparaben 0.098 (3) Propylparaben 0.029 (h) Butylparaben 0.0h9 (5) Glycerine (USP, 99%) U9.0 ^ (6) "Fumed" silicon oxide 0 to 2.5 20 (7) Karaya gum powder 50.0

For the durability tests, a simulated visceral fluid was prepared as described in U.S.P. XIX "Intestinal Fluid, Simulated, TS," pg. 765 (197 ^). Simulated urine pasture. Prepared as described in Remington's Pharmaceutical Sciences, Urine ", pg. 590-9 »Ed 15 (1975) · The tests to determine the dry tack and wet tack were performed according to a modification of the ASTM method 02979-71 with a 0.5 cm diameter stamp.

The equipment for determining durability comprises a tank containing the simulated visceral or urine and a number of three-legged test devices which can be placed in the tank in contact with the flow solution. The test device has a platform at the top with a floor in which the sample is placed. The central part of the floor has been cut out, so that an opening is formed by the platform. When placed in place, the samples bridge these openings. U-shaped weights are then placed over the samples. These weights are in the form of steel hooks weighing approximately 7.0 g. During use, these 80 059 9 0-10 hooks are placed over the samples so that when the hooks drop through the samples, they can fall freely through the openings in the platform. Nylon wires are attached to the upper transverse sections of the inverted U-shaped hooks and these wires are attached to the microswitch operating arms 5, while the length of the wires is selected so that when the sample breaks, the microswitch is converted and the measuring clock for the sample in question is stopped. At the start of the test, the samples are first placed in the tank and the wires attached to the microswitch, then the simulated urine or visceral liquid is introduced into the tank to a level above the location of the samples and the dial indicators are initiated for each sample. In this manner, the time elapsed before each sample breaks is recorded automatically.

The samples for the durability tests were cut sections 15 of rings formed from the compositions of varying silica content. Each test sample weighed about 1.0. g and an elongated shape. The central portions of the samples, which were loaded by the hooks, were approximately x 8 mm in size. The measured breakthrough time was corrected by dividing the measured time by the weight of the sample in grams.

For the adhesion tests, cut-out sections of the rings were applied to test discs with a central opening through which the adhesive tester protrudes. The dry tack was determined while the sample surface was dry, and the wet tack was determined after the sample had been contacted with water. The force required to separate the stamp from the sample was measured and expressed in grams and converted as grams per cm diameter of the stamp, this diameter was 0.5 cm · Duplicates were made with each sample and the final value was . calculated as the average of 5 equal samples.

The results obtained in the durability test and in the adhesion tests are summarized in table H below.

8 0 05 9 9 0 -11- TABLE Η $ Durability Durability

Si0o in simulated in simulated Tr, / n r urine hour visceral fluid - “- ^ - 5 __ hours Dry_Hat

None 2.0 hours 1.5 hours 216 324 0.25 / 5> 24 hours 16.0 hours 342 4o6 0.5 $ 18.75 hours> 24 hours 338 428 1.0 $> 24 hours> 24 hours 246 312 10 $ 1.75> 24 hours> 24 hours 164 270 2.5 $> 24 hours> 24 hours 100 270

Example XI

Other durability tests and adhesion tests were carried out using the composition described in Example 1. The silica content was varied from 0.2-4.0 wt.%. The total amount of silica and glycerine mixture was kept at 50% by weight, so that the amount of glycerine mixture increased accordingly. reduced when the amount of silicon oxide was increased. Durability was measured on an hour / g sample and the samples were prepared with a 0.25 cm diameter. The results obtained are summarized in Table J below.

TABLE J

$ Durability Durability

SiO 2 in simulated in simulated / Q

25 hours of urine liquid - “- 2 hours Dry_Hat_ 0.2 98.7 87.1 322 594 0.5 61.0 64.7 390 558 1.0 93 68 320 586 302.0 148.7 114.7 38 552 3.0 128.8 103.2 4 370? 4.0 132 71.5 0 334

Example X.

In any composition where the formed ring or sheet has an insufficiently dry adhesive, a coating of a suitable pressure sensitive adhesive may be applied to the side of the ring or sheet which will be against the skin of the wearer pressed.

8005990 -12-

For example, one can use a vinyl acrylic pressure sensitive adhesive for medical purposes, such as the adhesive H ^ 9 supplied by U.S. Pat. Adhesive Chicago Illinois. An adhesive may also be incorporated into the mixture to form, for example, in the form of an emulsion of the adhesive in glycerine.

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Claims (7)

1. Protective and sealing mixture in the form of a gelled ring. or a gelled sheet for use around a surgical draining hole for fluids, said mixture comprising a gellable, water-absorbing hydrocolloid gum and a non-toxic liquid polyvalent alcohol, characterized in that in the mixture 0.1-4.0. % colloidal silicon oxide is dispersed. 2. Mixture according to claim 1, characterized in that the silicon oxide is "fumed" 1 silicon oxide. 3. Mixture according to claim 1 or 2, characterized in that it contains 0.1-1.5% by weight of silicon oxide. Mixture according to claims 1-3, characterized in that the hydro-colloid gum is karaya gum. Mixture according to claims 1-4, characterized in that the polyhydric alcohol is glycerine or a mixture of glycerine and propylene glycol. 15 Mixture according to claims 1 to 5, characterized in that it also contains 2-15% by weight of sodium carboxymethyl cellulose. 7. Mixture according to claims 1-6, characterized in that it mainly consists of karayagcm and glycerine, in which 0.1-1.5 wt.% Of fumed silicon oxide is dispersed, together with 3-8 wt. $ sodium carbomethyl-20 cellulose. 80 059 9 0