FR2468355A1 - SEAL PROTECTIVE COMPOSITION, IN MOLDED FORM, FOR SURGICAL DRAINAGE OPENINGS - Google Patents

Abstract

The present invention relates to protective sealant compositions, in the form of molded sheets or rings intended to be applied around openings for surgical drainage of a fluid. These compositions comprise a gelled mixture of a particulate hydrocolloid gum absorbing water and a non-toxic liquid polyalcohol and their resistance to the action of the drained fluid (for example urine or intestinal fluids) is increased, in accordance with the invention, by incorporating a small amount of colloidal silica. It is preferred to use colloidal silica prepared by the dry route. By limiting the quantity of silica added, it is possible to avoid appreciable reductions in adhesiveness in a humid environment and / or in tackiness in a dry environment.

Description

The present invention relates to a composition

  sealing protector in molded form for opening

surgical drainage.

  Protective sealing compositions in the form of molded rings or sheets, intended to be applied

  located around surgical drainage drainage openings

  are known. According to a usual formulation, such compositions comprise a gelled mixture of Basra gum or karaya and glycerin. On this subject, one can refer for example to the patents of the United States of America Nos. 3,302,647 and No. 3,954,105. As described in the first of these patents, when it is a drainage orifice

  connected to a body conduit, the seal composition-

  karaya-glycerin can be used in the form

  a molded ring which is placed around said orifice

  this, between the joint of the ostomy appliance and the body

  of the patient wearing it. The purpose of this ring is to provide

  a protective seal, in other words to prevent the

  intestinal fluid or urine to escape from the pre-

  cited as a leak around the ring, so

  that all the discharged fluid is collected in the bag

  or pocket of the ostomy appliance. The seal ring-

  also plays a protective role in the region of

  skin surrounding the aforementioned opening with respect to the ir-

  laughing urine or intestinal fluid which, in the

  ileostomies, may contain gastric juices. Com-

  illustrated by the second of the aforementioned patents, the composition

  Karaya-glycerin may also be used in the form of a sheet or a dressing. Such dressings may also be used around natural orifices or, as

  described in patent No. 3,954,105, be implemented

  tower of drainage openings associated with injury or

to a surgical incision.

  The sealing compositions of the type described above preferably have an initial adhesiveness, usually called "adhesiveness in a dry medium", such that they ensure an initial adhesion, by adhesiveness,

  to the skin around the drainage opening. He left-

  especially important that these compositions provide a

  -2- high degree of adhesiveness when they are in contact with an aqueous fluid, this adhesiveness being usually called "adhesiveness in a humid medium". The hydrocolloid contained in the composition, such as the karaya, absorbs water, which causes the swelling of said hydrocolloid.

  and increases its stickiness. However, during an exhibition

  tion continues to the aqueous fluid, in particular when this fluid is urine or an intestinal fluid containing gastric juice, the composition tends to degrade, losing its mechanical resistance, and becomes fan of

  ineffective in its role as a protective seal

  as desired. Such sealing rings or dressings should be replaced frequently in practice. We wanted to increase the time during which

  such rings or dressings retain their properties

  mechanical and / or adhesive tees, but we have not found

  that at present no satisfactory means to achieve this result. The present invention is partly based on the fact that we have found that a new and surprising result

  is obtained by incorporating a small amount of sili-

  this colloidal preferably prepared by the dry route ("if-

  smoked strip "), in protective sealant compositions -

  which consist of a mixture of hydrocolloid gum

  polyalcohol daleet. More specifically, the resistance of these compositions, in the form of rings or molded sheets, to degradation by intestinal fluids and / or urine, is greatly increased by incorporation of only 0.2% of

  dry prepared silica. For concentra-

  tions of silica greater than 4.0%, the adhesiveness of the composition in a humid environment is reduced to a degree such that this composition is not effective. However, by limiting the amount of silica dispersed in the composition, the

  period during which the composition retains its properties

  mechanical tees can be increased without appreciable reduction

  its adhesiveness in a humid environment and a satisfactory adhesiveness

  Doing so in a dry environment can also be obtained.

- 3 -

  The present invention is applicable to the compounds

  protective sealants prepared from

  gelled mixtures of a particular hydrocolloidal gum

  re and a liquid polyalcohol, which can be in the form of rings or sheets molded and solidified or solidified by gelation. According to the tests carried out, the hydrocolloidal gum is preferably Basra gum or karaya, but other hydrocolloidal gums

  gellables can be used to replace partial-

  either the karaya or completely. Such hydro-

  colloidal gellables include ghatti gum, zedu, tragacanth, gelatin, dextran,

  pectin, xanthan and similar natural gums.

  We can use synthetic gums, such as carbon

  Sodium xymethylcellulose and sodium hydroxyethylcellulose Such hydrocolloid gums are characterized by

  that they are polysaccharides, that they are hydro-

  philes and that they absorb water, and that they are geli-

  reliable when mixed with glycerin or other polyalcohol.

  In the composition according to the invention, the hydrocolloid gums are used in a fine particulate form, that is to say in the form of powders. The karaya is for example usually used in a sufficiently

  finely divided, so that the powder has di-

  particle mensions at most equal to 0.149 mm. The gom-

  my powders as used are dry "in the air", that is to say dry to the touch, but they can contain

  a little humidity, for example 10 to 18% by weight of humidity

  you. The main liquid component of the sealing composition is preferably a non-toxic liquid polyalcohol. According to research, glycerin is

  preferred alcohol, but other poly-

  alcohols with similar properties, such as

  pylene glycol, sorbitol, etc. Preferably, the polyalcohol is not only non-toxic and non-irritant when applied to the skin, but it also has a calming or emollient activity, as in the case of glycerin

  or similar emollient polyalcohols.

  To prepare the sealing composition, a sufficient quantity of alcohol is used to form a flowable mixture, which can be made into the desired form of ring or sheet, for example by

  molding, and then solidified by gelation. The propor-

  The relative proportions of the polyalcohol and the hydrocoilide may vary while still giving these general results. If too little alcohol is present, the mixture is too consistent to flow into the mold while the molded composition is too soft and insufficiently

  gelled if too much alcohol is present.

  According to the practice of the present invention, in the case of mixtures of knraya and glycerin, good results are obtained with practically equal weights of the gum.

  and alcohol. However, a soft mixture can be prepared.

  lable using more or less glycerin or other poly-

  alcohol. In general, the mixture can contain 35 to 55%

  of karaya or other hydrocolloid and 35 to 55% of glycé-

  rine or other polyalcohol. More specifically, we can pre-

  adorn mixtures containing 80 to 120 parts by weight of

  glycerin per 100 parts by weight of karaya.

  In accordance with the present invention,

  pore of colloidal silica in the coating composition

  ment, this silica being preferably dispersed, so

  re homogeneous, in said composition. We prefer to use sili-

  this prepared by the dry route although it can also be used

  see a colloidal silica gel. The dry process silica is pro-

  pick by flame hydrolysis of silicon tetrachloride

  cium. It can be obtained from various manufacturers,

  for example under the name "Cab-O-Sil" (Cabot Corpora-

  ticn, Boston, Massachusetts) and under the name "Aerosil" (Degussa, Inc. New York, N. Y., United States of America). These products consist of silicon dioxide, under

  colloidal shape, with a very high specific surface

  vee. A specific product that is particularly suitable

  for example, the M-5 quality of the Cab-O-Sil.

  In the broadest aspect of this invention, the colloidal silica is incorporated into the composition in an amount of 0.1 to 4.0% by weight (these percentages as well as the other percentages indicated are expressed relative to the weight total composition, including the

  silica and all other ingredients of the finished product).

  For the specified proportion range, the shelf life of the properties of the gel-forming composition,

  while in contact with urine and / or fluids

  intestinal, is considerably increased while the adhesiveness in a humid environment remains adequate. However, it is preferable not to use more than 1.5% of silica

  (i.e. 0.1 to 1.5%) so that the properties

  dry adhesion and medium adhesiveness tees

  are more completely preserved.

  It has been found desirable to incorporate sodium carboxymethylcellulose (CMC) into the mixture to reduce its viscosity and facilitate its molding or other form of shaping. For example, 2 to 15% CMC can be used. In accordance with characteristic formulations, 3 to 8 parts by weight of CMC are combined and 0.5 to 1.2 parts by weight of dry silica at 40-50% parts of each of the

  two constituents that form karaya and glycerin.

  When CMC is not used, the optimal amount of this silica is somewhat lower, for example

only 0.2 to 0.8% of the mixture.

  The compositions may include ingredients

  secondary, in small quantities, such as preservatives

  anti-bacterial agents. We can use by

  example, as a preservative, a para-hydroxyben-

  alkyl zoate (paraben) or a mixture of such benzoates,

  in particular a mixture of methyl-, ethyl-, propyl- and butyl-

  parabens. When using parabens, for example in

  amounts of O 1 to 0.5%, it may be desirable to dissolve

  dre first these parabens in propylene glycol or other co-solvent with glycerin, in which the parabens are more soluble than in glycerin. For example, 2 to 10 parts of propylene glycol can be used per 100 parts -6-

glycerin.

  When combining the ingredients to prepare the flowable molding composition, the parabens can first be dissolved in the small amount of propylene glycol and the solution of the parabens in the propylene glycol then be mixed with the glycerin which represents a larger quantity. Dry process colloidal silica can be

  then dispersed in the combined polyalcohols, by mixing juice -

  only to obtain a uniform dispersion. Gum powder

  hydrocolloidal is then added and the metering operation

  diaper is continued until the composition is homo

  homogeneous. This composition is then molded before gelling.

  cation, the latter may occur after 5 to 10 minutes. For molding, the composition can be poured

  in ring molds or flat molds for molds

  age of leaves and it can be put in the desired form

  created under slight pressure, for example by using, as a top mold element, a movable element or plate. During the molding process, the composition is

  solidifies quickly to give a gelled mass. When-

  as desired, gelation can be promoted by heating the composition, either in the mold or after molding. For example, microwave composition may be applied to the composition while it is in the mold, or the molded rings may be passed through or

  the sheets molded in an infrared heating tunnel

  ge. The heating temperature is not critical since gelation occurs and becomes complete at room temperature. However, by heating the molded sheets or rings to a temperature of about 71 to 820 C, the solidification and gelling are completed

  after a shorter period. During the solidification

  cation, there is usually no loss of polyalcohol and the composition therefore does not need to be

  heated to a temperature above the boiling point

lition of said polyalcohol.

  The present invention is illustrated by the preferred embodiments below, with reference to the examples

  following which also give the results obtained.

EXAMPLE I

  In a currently preferred reaction mode,

  a protective sealing composition is prepared.

  form to the present invention using the following formulation:

FORMULATION

  Ingredients% by weight (1) 2% if colloidal silica prepared by dry process (a) in glycerin-based mixture (d) 50.0 (2) Karaya powder (b) 45.0 (3) Sodium carboxymethylcellulose ( CMC) (c) 5.0.0 (a) Makes 1% dry colloidal silica: Cab-0-Sil M-5 (Cabot Corporation, Boston, Massachusetts) o (b) Particle sizes less than 0.105 mm; at 18% humidity (c) CMC 7HOX8F (Hercules, Incorporated, Wilmington,

Delaware).

  (d) Glycerin-based mixture: 94.795% glycerin, 4.839% propylene glycol, 0.161%. of methylparaben

and 0.177% butylparaben.

  To obtain the composition from the abovementioned ingredients, the glycerin-based mixture in which the colloidal silica prepared by the dry route is uniformly dispersed, is mixed with the karaya powder and the sodium carboxymethylcellulose until obtaining a uniform gelable mixture. This mixture, before gelation, is poured into molds to form rings or sheets and it is subjected to maturation, in these molds, to obtain the product in the form of a ring or sheet. The hardening can be obtained by leaving the composition in - 8 -

  mussels for 16 hours at room temperature

  you. According to another embodiment, the hardening

  can be accelerated by heating using a rayon-

  infrared or microwave. Micro heating

  waves is preferred. To improve the adhesiveness in a dry environment, if it is desired to be so, it is deposited in the bottom of the molds

  before filling with the mixture, a low quan-

  tzr of suitable pressure sensitive adhesive. By

  example, pressure sensitive adhesive may be the

  "H 49" vinyl acrylic, for medical use,

  qué by U.S. Adhesives, Chicago, Illinois, United States of America.

EXAMPLE II

  According to another embodiment, a protective sealing composition is prepared in accordance with the present invention using the following formulation:

FORMULATION B

  Ingredients% by 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) Colloidal silica prepared by route dry 0.50 (7) Karaya powder 50.50, 000 To mix the above ingredients, parabens, i.e. ingredients (2) to (4), are

  dissolved in ingredient (1), i.e. propylene-

  glycol. The solution obtained is added to the ingredient

  (5), i.e. glycerin, and mixed until

  tion of a uniform product. The ingredient (6), that is to say the colloidal silica prepared by the dry route, is then

  dispersed in the liquid solution of the above ingredients

  - 9 - teeth and this dispersion is mixed until a homogeneous state is obtained. Then add the karaya powder,

  that is to say the ingredient (7), while continuing the operation

  mixing ration until a general composition is obtained

  homogeneous readable. This composition, before gelation, is poured into molds to form rings or

  leaves and it is subject to hardening, in the-

  so-called molds to obtain the desired products in the form of rings or sheets. Hardening can be obtained

  leaving the composition in the molds for approx.

  ron 16 hours, at room temperature. According to another embodiment, the hardening can be accelerated by heating by means of infrared radiation or

  microwave. In the previous example, the silica collected

  The dale used is Cab-O-Sil M-5 (Cabot Corporation, Boston, Massachusetts). The karaya is in the form of a powder with smaller particle sizes

  at 0.105 mm, this powder which can contain 10 to 18% of

midity.

EXAMPLE III

  A composition is prepared as described in Example II, except that the karaya powder is replaced

  by an equal weight of alginine powder. The algin is supplied

  denied by Kelco Company, Clark, New Jersey.

EXAMPLE IV

  Using the mixing process described in Example II, a protective sealing composition in accordance with the following formulation is prepared:

FORMULATION C

  Ingredients% by weight (1) Propylene glycol 2.88 (2) Methylparaben 0.098 (3) Propylparaben 0.017 (4) Butylparaben 0.105 (5) Glycerin (purity: 99%) 56.4 (5) Glycerin (purity: 99% ) 5,

- 10 -

  FORMULATION C (continued) (6) Colloidal silica prepared by the dry route 0.5 (7) Xanthan gum. 4.0.0, 000 In the above formulation, xanthan gum is a food grade product supplied by Kelco

Company, Clark, New Jersey.

EXAMPLE V

  A protective sealant composition is prepared.

  using the mixing and molding process of Example II, applying it to the following formulation:

FORMULATION D

  Ingredients% by weight (1) Propylene glycol. 2.37 (2) Methylparaben 0.079 (3) Propylparaben 0.014 (4) Butylparaben 0.087 (5) Glycerin (purity: 99%) 46.45 (5A) Sorbitol (purity: 70%) 5.0 (6) Silica colloidal prepared by the dry route 1.5 (7) Zedou gum powder 44.5, 000 When mixing the above-mentioned ingredients, glycerin and sorbitol, that is to say ingredients (5) and (5A), are combined as described for the ingredient

  (5), i.e. glycerin, in the process of the ex-

ple I.

EXAMPLE VI

  A protective sealant composition is prepared.

  in accordance with the mixing process of Example II,

  using the formulation below.

- he -

FORM4ULATION E

  Ingredients (1) Propylene glycol (2) Methylparaben (3) Propylparaben (4) Butylparaben (5) Glycerin (purity 99%) (6) Colloidal silica prepared by dry process (7) Carboxymethylcellulose-sodium% by weight 3.05 0 , 10 0, 02 0.11 l 59.72 2.0, 0, 000 Sodium carboxymethylcellulose is CMC 7HOXF supplied by Hercules, Incorporated, Wilmington,

  Delaware. The molded rings or sheets are preferably

  this subjected to curing by heating by means of micro-

waves.

EXAMPLE VII

  A protective sealant composition is prepared.

  corresponding to the following formulation:

FORMULATION F

  Ingredients (1) Propylene glycol (2) Methylparaben (3) Propylparaben (4) Butylparaben (5) Glycerin (purity 99%) (6) Deionized water (7) Colloidal silica prepared by dry process (8) Carboxylethylcellulose-sodium (9) ) Karaya powder% by weight 2.71 0.09 0.020 0.1 53.08 3.0 1.0, 0, 0, 000

- 12 -

  To prepare this composition from the

  above ingredients, the same mixing process as in Example II is used, with regard to ingredients (1) to (5). The ingredient (6), that is to say the deionized water, is then added and the homogenization is continued until a uniform mixture is obtained. The ingredient (7) (silica prepared by dry goose) is then dispersed in

  the liquid solution so as to form a uniform dispersion

  form. The ingredient (8), i.e. the carboxymethylcel-

  lulose-sodium is then added while continuing the

  diaper and the ingredient (9), ie karaya, is added

  t last, the mixing operation being continued until a uniform gelable composition is obtained. The

  molding and gelling process is the same as this-

describes him in Example II.

EXAMPLE VIII

  Tests are carried out to determine the shelf life, properties and adhesiveness using the following basic formulation and quantities of colloidal silica prepared by the dry route (CabO-Sil

M-5) from O to 2.5%.

BASIC FORMULATION

  Ingredients Parts by weight (1) Propylene glycol 0.735 (2) Methylparaben 0.098 (3) Propylparaben 0.029 (4) Butylparaben 0.049 (5) Glycerin (purity: 99%) 49.04 0 (6) Colloidal silica prepared by the dry route O to 2.5 (7) Powder de-karaya 50.0 For the tests of shelf life of properties, a simulated intestinal fluid such as dacrit is prepared in Pharmacopoeia of the United States of America, XIX

  "Intestinal Fluid, Simulated, TS," page 765 (1974). The uri-

  no simulated is prepared as described in Remington's

- 13 -

  Pharmaceutical Sciences, "Urine", pages 598-599, 15th edition (1975). The adhesiveness tests in dry and wet conditions are carried out using a modification of the method ASTM 02979 - 71, using a probe of 0.5 cm in diameter. The apparatus for testing the duration

  storage container includes a container for

  hold simulated intestinal fluid or simulated urine and more

  Several tripod fixing devices, intended for the test, which can be placed in the container, in contact with the solution. The fixing device comprises, at its top,

  a platform provided with a recess for receiving the sample

  lon. The central part of the recess is cut so

  to present an opening which crosses the platform. When-

  that the test samples are placed in the position

  corresponding to the test, they form bridges on the openings.

  Weights, U-shaped, are placed on said samples.

  These weights are in the form of steel hooks weighing approximately 7.4 grams. In the position of use, the hooks are placed on the samples so that, when these hooks break the samples and pass through them, they

  fall freely through the platform openings

  shapes. Nylon threads are attached to the parts

  upper, forming transverse arms, hooks in form

  me of inverted U, said wires also being connected

  to the microswitch control levers and the long

* feeders of said wires being chosen so that, when the sample is broken, the microswitch is actuated while a recording clock corresponding to the particular sample is stopped. When we start

  after placing the samples in the tank

  see and attach the wires to the levers of the micro-switches

  We introduce the simulated urine or the simulated intestinal fluid into the tanks to a level higher than that of the samples and start the clocks.

  register corresponding to the different samples.

  The length of time until each sample breaks

  it is automatically registered.

- 14 -

  Samples for testing

  mination of the properties shelf life are

  suitably cut portions of rings from

  resulting from the molding of formulations corresponding to te-

  variable values in colloidal silica prepared by the dry process. Each test sample weighs approximately 1.0 g and

  is elongated. The central parts of the samples-

  lons, on which the tared hooks are engaged have

  dimensions of approximately 3.8 to 7.6 cm. The measurement of the-

  The time elapsed until rupture is corrected as follows: the duration measured is multiplied by 1.0 g of the sample and divided by the actual weight of said sample. For

  the adhesiveness tests, of the cut portions of the an-

  They are applied to test discs with a central opening through which the adhesion probe extends. Adhesiveness in a dry environment is determined while the surface of the sample is in a dry state while adhesiveness in a wet environment is determined

  after putting the sample in contact with water.

  The force required to separate the probe from the sample

  It is measured in grams and recorded in grams per centimeter of diameter of the probe, this diameter being 0.5 cm. The tests carried out on each example are repeated and the values recorded are averages for five

identical samples.

  The results obtained in these adhesion tests

  properties and shelf life are summarized

més in table A below.

- 15 -

TABLE A

  % of colloidal silica prepared by dry method Nil 0.25 d 0.5%

1.0%

1.75%

2.5%

Contact time Contact time

  servation of the servation of the properties properties in the urine in the simulated simulated urine 2.0 h more than 24 h 18.75 h more than 24 h more than 24 h more than 24 h 1.5 h 16.0 h more than 24 h more than 24 h more than 24 h more than 24 h Adhesiveness (g / 0.5 cm) medium dry moist environment

EXAMPLE IX

  Other tests of adhesiveness and

  shelf life of properties using the form-

  basic mulation as well as the process given in the example

  ple I. The silica content is varied from 0.2 to 4.0%.

  The total of the colloidal silica prepared by the dry route and of the glycerin-based mixture is maintained at 50% by weight, the amount of this glycerine-based mixture being correspondingly reduced when the amount of this colloidal silica increases. The retention times of the properties are expressed in hours per gram of test sample, the diameter of said test samples being 0.25 cm. The results obtained are summarized in the table

B below.

--16 - '

TABLE B

  % of colloidal silica prepared by the dry route 0.2 0.5 1.0 2 0 3.0 4.0 Test of shelf life of properties (h / g) Simulated urine 98.7 61.0 148.7 128.8 Simulated intestinal fluid! 6 87.1 64.7 114.7 103.2 1.5 Adhesiveness (g / O, 5 cm) in a dry humid environment -4 or 59 hours

EXAMPLE X

  In any formulation in which the molded sheet or ring has insufficient adhesiveness in a dry environment, a side can be applied to the side of the ring or sheet which will be pressed against the wearer's skin.

  coating with suitable pressure sensitive adhesive.

  For example, a vinyl acrylic adhesive can be used

  pressure sensitive, medical use, such as

  sif H 49, manufactured by U.S. Adhesives, Chicago, Illinois, United States of America. According to another embodiment,

  an adhesive can be incorporated into the mixture, before molding

  ge, for example in the form of an emulsion of the adhesive

in glycerin.

- 17 -

Claims (7)

R E V E N D I C A T I 0 N S   I. A protective sealing composition, in the form of a gelled, molded sheet or ring, intended to be applied around a surgical drainage opening for a fluid, this composition   taking a mixture of a particular hydrocolloid gum   re absorbable and gellable and of a liq.ui polyalcohol   non-toxic, characterized in that it contains 0.1 to 4.0% by weight of colloidal silica dispersed in said composition.   2. Composition according to claim 1, charac-   terized in that the aforementioned colloidal silica is prepared dry process known as fumed silica.   3. Composition according to claim 1 or 2, characterized in that the aforementioned silica is present in   an amount of 0.1 to 1.5% by weight.   4. Composition according to one of claims   previous, characterized in that the hydrocolloida- gum   the above is karaya powder.   5. Composition according to one of claims   above, characterized in that the aforementioned polyalcohol   is glycerin or a mixture of glycerin and propylene ne-glycol.   6. Composition according to one of claims   previous, characterized in that it also contains 2   15% by weight of sodium carboxymethylcellulose.   7. Composition according to claim 1, charac-   terized in that it essentially consists of a mixture of karaya powder and glycerin in which 0.1 to 1.5% by weight of colloidal silica are dispersed   prepared dry and 3 to 8% by weight of carboxymethyl- sodium thylcellulose.