JPS6121103B2 - - Google Patents

Description

[Detailed description of the invention]

INDUSTRIAL APPLICATION This invention relates to a protective sealing composition in the form of a molded ring or sheet for application around a surgical drain. BACKGROUND OF THE INVENTION Protective sealing compositions in the form of molded rings or sheets for application around surgical drains are known. Such compositions generally consist of a gelling mixture of karaya gum and glycerin. See, for example, US Pat. Nos. 3,302,647 and 3,954,105. When the drainage port is a stoma, as described in the first cited patent, the Karaya-glycerin sealing composition is applied around the stoma between the gasket of the anastomotic device and the body. Used in the form of a molded ring that is placed. The purpose of the ring is to provide a protective sheet. That is, intestinal fluid or urine discharged from the small hole is prevented from leaking around the ring, and all of the discharged fluid is collected in the bag or pouch of the anastomotic device. In the case of an ileal or intestinal anastomosis, the urine or intestinal fluids also contain gastric fluids, and the sealing ring serves to prevent irritation and burning of the skin around the stoma on the patient's body. As described in the second patent, the Karaya-glycerin compositions may be used in the form of sheets or blankets. Such blankets may be used around small holes or around drainage from wounds or surgical incisions as described in US Pat. No. 3,954,105. PROBLEM TO BE SOLVED BY THE INVENTION This type of sealing composition usually preferably has an initial tack, referred to as "dry tack", which means that it does not adhere to the skin around the drainage hole. Good adhesion is desirable. It is particularly important that the composition be highly adhesive when in contact with liquids. This is commonly referred to as "wet tack." The hydrocolloid in the composition, such as Karaya, absorbs water causing the hydrocolloid to swell and become sticky. However, upon continued contact with fluids, especially if the fluid is urine or intestinal fluids containing gastric fluids, the composition will break down and lose its mechanical strength, rendering the desired protective sealing function ineffective. Therefore, such sealing rings or blankets must be replaced frequently. It is therefore desirable to increase the mechanical durability and/or adhesive durability of such rings or blankets, but heretofore there has been no good means for achieving this objective. SUMMARY OF THE INVENTION The present invention incorporates a small amount of colloidal silica, preferably in the form of fumed silica, into a protective sealing composition comprising a mixture of hydrocolloid gum and polyhydroxyalcohol. It is based on the discovery that new and surprising effects can be obtained by Briefly, the present invention provides a protective sealing composition in the form of a shaped gelling ring or sheet for application around a surgical drainage port.
The composition comprises a mixture of a water-absorbing particulate hydrocolloid gum capable of gelling and a non-toxic liquid polyhydroxy alcohol, with 0.1 to 4.0% by weight of colloidal silica selected from the group consisting of fumed silica and colloidal silica gel dispersed therein. The present invention provides a protective sealing composition characterized in that: More particularly, according to the invention, the resistance of the composition in the form of a shaped ring or sheet to modification by intestinal fluids and/or urine is 0.2
% of fumed silica. Silica concentration is 4.0
If it is higher than %, there will be a problem that the adhesiveness of the composition in a wet state will be reduced. However, by appropriately limiting the amount of silica dispersed in the composition, the mechanical durability of the composition can be increased, while the wet tack is not reduced, and good dry tack can also be obtained. It will be done. OPERATION The present invention utilizes protective sealing compositions made from a gelling mixture of a particulate hydrocolloid gum and a liquid polyhydroxyalcohol that is formed into a ring or sheet and hardens by gelation.
According to current usage, the hydrocolloid gum is preferably gum karaya, although other gellingable hydrocolloid gums may be used as partial or complete substitutes for gum karaya. Examples of such hydrocolloid gums that can be gelled include Gatsuchi gum;
These include zedau, gum tragacanth, gelatin, dextrin, pectin, xanthan and similar natural gums. Synthetic gums such as sodium carboxymethyl cellulose and hydroxyethyl cellulose may also be used. These hydrocolloid gums are polysaccharides, which are hydrophilic and water-absorbing, and have the characteristics of being able to gel as a mixture with glycerin and other polyhydroxyalcohols. For purposes of the present invention, hydrocolloid gums are used in the form of fine granules (ie, powders). For example, karaya gum is usually used in powder form fine enough to pass through a sieve of 100 mesh or less. The powdered rubber used is air-dried to a touch-dry state, but may contain some moisture, on the order of 10-18% by weight. The primary liquid component of the sealing composition is preferably a non-toxic liquid polyhydroxyalcohol. According to current applications, glycerin is the preferred alcohol, but other polyhydroxy alcohols with similar properties, such as propylene glycol,
Sorbitol etc. can also be used. Preferably, when applied to the skin, the polyhydroxy alcohol is not only non-toxic and non-irritating to the skin, but also has a soothing or alleviating effect. In making the encapsulating composition, a sufficient amount of polyhydroxy alcohol is used to form a flowable mixture that is formed into the desired ring or sheet shape and then cured by gelation. The relative proportions of polyhydroxy alcohol and hydrocolloid can be varied as appropriate. If too little alcohol is present, the mixture will be too hard to cast into molds, and if too much alcohol is present, the composition will be too soft and will not gel well. For mixtures of Karao gum and glycerin, good results are obtained if approximately equal amounts of gum and alcohol are used. However, castable mixtures can be prepared with greater or lesser amounts of glycerin or other polyhydroxy alcohols. Generally, the mixture contains 35-55% karaya gum or other hydrocolloid gum and 35-55% glycerin or other polyhydroxy alcohol. Generally, the mixture is 80% per 100 parts by weight of karaya gum.
Prepared using ~120 parts by weight of glycerin. According to the invention, colloidal silica is incorporated into the sealing composition, and the silica is preferably homogeneously dispersed. Fumed silica is particularly preferred, but colloidal silica gels can also be used. Fumed silica is produced by flame hydrolysis of silicon tetrachloride. It is commercially available from a variety of manufacturers, including "Cab-O-Sil" from Cabot Corporation, Boston, Mass.
and "Aerosil" products from Degussa, Inc. of New York. These products are silicon dioxide in colloidal form with a very high surface area. For example, one suitable product is Grade
It is M-5 Cab-O-Sil. According to the invention, the colloidal silica is between 0.1 and 4.0
It is incorporated into the composition in an amount of % by weight. The percentages herein are based on the total weight of the composition. The presence of silica in amounts within the aforementioned ranges significantly enhances the durability of the gel composition in contact with urine and/or intestinal fluids without compromising the tackiness in the wet state. However, in order to better maintain dry and wet tack, it is preferred not to use more than 1.5% silica (ie, the preferred usage is between 0.1 and 1.5%). It has been discovered that it is desirable to incorporate sodium carboxymethyl cellulose (CMC) into the mixture to reduce its viscosity and facilitate casting or molding. For example, 2-15%
CMC is used. Typical composition is CMC3~
8 parts by weight, 40-50 parts by weight of Karaya gum, glycerin
40-50 parts by weight and 0.5-1.2 parts by weight of fumed silica. If CMC is omitted, the optimal amount of fumed silica is reduced somewhat, e.g.
It is 0.2-0.8%. The compositions may also contain other minor ingredients, such as preservatives or bactericidal agents. As preservatives, alkyl parahydroxybenzoates (parabens) or mixtures thereof, such as methyl,
Mixtures of ethyl, propyl and butyl parabens can be used. When using parabens in an amount of, for example, 0.1 to 0.5%, it is preferable that the parabens are first dissolved in propylene glycol, which is a co-solvent for glycerin, or the like, in which the parabens are more soluble than in glycerin. For example, 2 to 10 parts of propylene glycol per 100 parts of glycerin can be used. When preparing a casting composition by mixing the ingredients,
The parabens are first dissolved in a small amount of propylene glycol, and then the paraben propylene glycol solution is mixed with a large amount of glycerin. Thereafter, the fumed silica is dispersed in the polyhydroxy alcohol and mixed until a uniform dispersion is obtained. Next, add hydrocolloid gum powder,
Continue mixing until the composition is uniformly mixed. The composition is shaped before gelling, and gelling takes place between 5 and 10
Happens within minutes. For molding, the composition is poured into a ring or sheet mold and molded into the desired shape using light pressure using a movable casting die or plate as the upper molding member. During the molding process, the composition rapidly hardens to a gel state. Gelation can optionally be promoted by heating the composition in the mold or after molding. For example, the composition in the mold may be subjected to microwave heating, or the formed ring or sheet may be passed through an infrared heating oven. The heating temperature is not critical since gelation can occur and be completed even at room temperature. However, molded sheets or rings from approx.
By heating to a temperature of 82.2°C (160-180°), curing and gelation are completed within a shorter period of time. To avoid loss of polyhydroxy alcohol during curing, the composition must not be heated above the boiling point of the polyhydroxy alcohol. EXAMPLES The present invention will be explained in more detail by the following examples (hereinafter simply referred to as examples). EXAMPLES Protective sealing compositions are prepared in accordance with the present invention using the compositions described below as preferred embodiments. Composition A component weight % (1) Glycerin mixture containing 2 g humid silica (a) (d) 50.0 (2) Karaya gum powder (b) 45.0 (3) Sodium carboxymethyl cellulose
(CMC) (c) 5.0 100.0 (a) Provides 1% fumed silica: Cab-O
-Sil M-5 (Cabot Corporation, Boston, MA) (b) <140 mesh; 10-18% moisture (c) CMC 7HOX8F (Hercules, Incorporated, Wilmington, DE) (d) Glycerin mixture: 94.795% glycerin,
4.839% propylene glycol, 0.161% methylparaben, 0.028% propylparaben, and
0.177% Butylparaben. When mixing the components, the humid silica, homogeneously dispersed glycerin mixture is mixed with the karaya gum powder and sodium carboxymethyl cellulose until a homogeneous gelatable mixture is obtained. This mixture is poured into a mold to form a ring or sheet before gelling, and cured in the mold to produce a ring or sheet product. Curing is accomplished by leaving the composition in the mold at ambient room temperature overnight. Alternatively, curing may be accelerated by infrared or microwave heating. Particularly preferred is microwave heating. To improve dry tack, if desired, a suitable pressure-sensitive adhesive is placed on the bottom of the mold before filling with the mixture. For example, adhesives in the United States;
“H49” from USAdhesives in Chicago, Illinois
vinyl-acrylic medical pressure-sensitive adhesives. EXAMPLES In another embodiment, the following compositions are used to prepare protective sealing compositions in accordance with the present invention. Composition B component weight% (1) Propylene glycol 2.25 (2) Methylparaben 0.075 (3) Propylparaben 0.013 (4) Butylparaben 0.082 (5) Glycerin (99% purity) 46.58 (6) Humid silica 0.50 (7) Karaya gum powder 50.50 100.000 When mixing the above components, the parabens of components (2) to (4) are dissolved in the propylene glycol of component (1).
This solution is added to component (5) glycerin and mixed until homogeneous. The fumed silica of component (6) is then dispersed in the liquid solution of said component;
The dispersion is dispersed and the dispersion is mixed until homogeneous. Thereafter, ingredient (7), karaya gum powder, is added with continued mixing until a homogeneous gelatinable mixture is obtained. This mixture is poured into a mold to form a ring or sheet before gelling, and cured in the mold to produce a ring or sheet product. Curing is accomplished by leaving the composition in the mold at ambient room temperature overnight. Alternatively, curing may be accelerated by infrared or microwave heating. In this example, the fumed silica used was
Cab-O-Sil M-5 (manufactured by Cabot Corporation, Boston, Mass.). Karaya gum is in the form of a powder that passes through a 140 mesh sieve and contains 10-18% moisture. EXAMPLE A composition was prepared exactly as in the example except that instead of karaya gum powder an equal weight of algin powder was used. Algin is supplied by Kelco Company of Clark, New Jersey. EXAMPLE A protective sealing composition was prepared according to the procedure of the example using the composition below. Composition C component weight% (1) Propylene glycol 2.88 (2) Methylparaben 0.098 (3) Propylparaben 0.017 (4) Butylparaben 0.105 (5) Glycerin (99% purity) 56.4 (6) Humid silica 0.5 (7) Xanthan gum 40.0 100.000 In the above composition, the xanthan gum is a food grade product supplied by Kelco Company of Clark, New Jersey. EXAMPLE A protective sealing composition was prepared using the following composition as described in the example procedure. Composition D component weight% (1) Propylene glycol 2.37 (2) Methylparaben 0.079 (3) Propylparaben 0.014 (4) Butylparaben 0.087 (5) Glycerin (99% purity) 46.45 (5A) Sorbitol (70% purity) 5.0 (6) Humid silica 1.5 (7) Zedau gum powder 44.5 100.000 When mixing the above ingredients, ingredients (5) and (5A)
The glycerin and sorbitol are combined as described for component (5) glycerin in the example procedure. EXAMPLE A protective sealing composition was prepared using the following composition as described in the example procedure. Composition E component weight% (1) Propylene glycol 3.05 (2) Methylparaben 0.10 (3) Propylparaben 0.02 (4) Butylparaben 0.11 (5) Glycerin (99% purity) 59.72 (6) Humid silica 2.0 (7) Sodium carboxy methylcellulose
35.0 100.000 Sodium Carboxymethyl Cellulose, Hercules, Wilmington, Terrace;
CMC 7HOXF supplied by Incorporated
It is. The molded ring or sheet is preferably cured by microwave heating. EXAMPLE A protective sealing composition was prepared using the following composition. Composition F component weight% (1) Propylene glycol 2.71 (2) Methylparaben 0.09 (3) Propylparaben 0.020 (4) Butylparaben 0.1 (5) Glycerin (99% purity) 53.08 (6) Deionized water 3.0 (7) Humid Silica 1.0 (8) Sodium Carboxymethyl Cellulose
15.0 (9) Karaya Gum Powder 25.0 100.000 When mixing the above ingredients, the same mixing procedure as in the example is used for ingredients (1) to (5). Thereafter, ingredient (6), deionized water, is added and mixing is continued until a homogeneous mixture is obtained. Thereafter, component (7), fumed silica, is dispersed in the solution to form a uniform dispersion. Thereafter, component (8), sodium carboxymethylcellulose, is added with continuous mixing, and finally component (9), karaya gum powder, is added, and mixing is continued until a uniform gelatinable composition is obtained. The shaping and gelling procedure is the same as in the example. Example: The amount of silica (Cab-O-Sil M-5) is 0 to 2.5.
Durability and tack tests were conducted using the following base compositions, varying over a range of %. Basic composition component parts by weight (1) Propylene glycol 0.735 (2) Methylparaben 0.098 (3) Propylparaben 0.029 (4) Butylparaben 0.049 (5) Glycerin (99% purity) 49.04 (6) Humid silica 0to2.5 (7) Karaya Gum Powder 50.0 For durability tests, samples of intestinal fluid were tested at U.
SPXIX “Intestinal Fluid, Simulated, TS”
(765, 1974). Urine sample is Remington's
Pharmaceutical Science, “Urine” (Nos. 598-599)
15th edition, 1975). Dry and wet tack tests using ASTM 0.5 cm diameter probes
This was done by applying Method 02979-71. The durability test device has a tank containing a sample of intestinal fluid or urine, and a plurality of tripod-mounted fixtures placed in the tank so as to be in contact with the sample liquid. The tripod fixture has a base having a recess at the top for receiving the test material. The center of the recess is cut out and has a hole passing through the platform. When carrying out the test, the test material is bridged into said hole. A U-shaped weight is then placed on the test material. This hook-shaped steel weight has a weight of approximately 7.4 g. This U
The glyph hook is placed on top of the test material so that when the hook ruptures the test material, it falls freely through the hole in the platform. A nylon string is attached to the end of the U-shaped hook, and this string is attached to the control lever of the micro switch. is adjusted so that it stops. To begin the test, place the test material in the tank, attach the string to the microswitch lever, then pour the urine or intestinal fluid sample into the tank until it is above the level of the test material and start the clock. . The time taken for each test material to break is thereby automatically recorded. The test materials for the durability tests were ring sections molded from compositions with varying silica contents. Each test material weighed approximately 1.0 g and had a stretched shape. The center of the test material where the hook-like overlap hits is approximately 3.8 mm x 7.6
It had a size of mm (0.15 inch x 0.3 inch). The measurement time until tearing was corrected by dividing the actual weight of the test material by 1.0 g and multiplying it by the measurement time. For the tack test, a section of the ring was placed over a test disk that had a hole in the center through which the tack probe extended. Dry tack was measured with the surface of the test material dry, and wet tack was measured after the test material was brought into contact with water. The force required to separate the probe from the test material was measured and expressed as grams per 0.5 cm probe diameter. The test was repeated five times for each test material and the average value was calculated. The results obtained for the durability and tack tests are summarized in Table A below.

Table: Examples Further durability and tack tests were carried out using the basic compositions described in the examples. The silica content was varied in the range of 0.2-4.0%. The total amount of fumed silica and glycerin mixture was kept at 50% by weight, and as the amount of fumed silica was increased, the amount of glycerin mixture was decreased accordingly. Durability time is expressed in hours per gram of test material, and the test material was prepared to have a diameter of 0.25 cm. The results obtained are summarized in Table B below.

[Table] Example: Even if the dry adhesion of a molded ring or sheet is insufficient, it can still function effectively by coating the side of the ring or sheet that is pressed against the patient's skin with an appropriate pressure-sensitive adhesive. can be accomplished. For this purpose, vinyl-acrylic medical pressure sensitive adhesives can be used, for example, adhesive H49 supplied by USAdhesives of Chicago, Illinois, USA. Alternatively, it may be mixed into the mixture before being molded into a glycerin emulsion with an adhesive. EFFECTS OF THE INVENTION By incorporating a small amount of colloidal silica selected from fumed silica and colloidal silica gel into a protective sealing composition consisting of a mixture of hydrocolloid gum and polyhydroxy alcohol, molded rings or sheets can be formed. The durability against deterioration by urine is significantly increased, the mechanical durability is increased, the tackiness in wet conditions does not decrease, and good dry tackiness is also obtained.

Claims (1)

Claims: 1. A protective sealing composition in the form of a molded gelling ring or sheet for application around a surgical drain, said composition comprising a gelatable, water-absorbing granular hydrocolloid gum. and a non-toxic liquid polyhydroxyalcohol, wherein said composition has 0.1 to 4.0% by weight of colloidal silica selected from the group consisting of fumed silica and colloidal silica gel dispersed therein. composition for stopping use. 2. A composition according to claim 1, wherein the silica is present in an amount of 0.1 to 1.5% by weight. 3. The composition according to claim 1 or 2, wherein the hydrocolloid gum is karaya gum powder. 4. The composition according to any one of claims 1 to 3, wherein the polyhydroxy alcohol is glycerin or a mixture of glycerin and propylene glycol. 5. A composition according to any one of claims 1 to 4, wherein the composition also contains 2 to 15% by weight of sodium carboxymethylcellulose. 6. The composition of claim 1, wherein the composition consists essentially of a mixture of 0.1-1.5% by weight of glycerin and karaya gum powder dispersed with fumed silica and 3-8% by weight of sodium carboxymethyl cellulose.