JP2001170159A - Contact skin member having buffering capability - Google Patents

Abstract

PROBLEM TO BE SOLVED: To eliminate a problem of bringing about a large skin disturbance due to strong enzyme activity of an excreted liquid excreted from a fistula or the like indicating a pH for giving an adverse influence to the skin. SOLUTION: The contact skin member for adhering a bag for recovering an excreted liquid to the surface of a skin is formed by mixing a hydrophobic polymer with a hydrophilic polymer. As the hydrophobic polymer, a polymer for forming no matrix and a polymer for forming a small amount of the matrix are used in combination. The hydrophilic polymer is formed by mixing a polymer having an action for buffering the pH and the other polymer. Since the hydrophilic polymer having the action for buffering the pH is held by the hydrophobic polymer for forming the small amount of the matrix, the excreted liquid excreted from the fistula or the like is easily contacted with the hydrophilic polymer to buffer the pH of the excreted liquid to weaken its enzyme activity and to effectively maintain an adhered state as well without giving the adverse influence to the skin.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a skin-contacting member to be attached to a fistula or the like.

[0002]

2. Description of the Related Art The state in which the epithelial surface of an organ or organ and the epithelial surface of another organ or organ communicate with each other is called a fistula. ”And“ external fistulas ”connecting the skin of the body surface and the visceral epithelium. Since the external fistula is a kind of open wound, its management is performed based on the principle of open wound.However, in this external fistula, internal secretions and exudates from the fistula are constantly or intermittently excreted. The management of the wound must be performed while performing the above processing.

[0003] In particular, in a fistula with a large amount of drainage represented by a small intestinal fistula, since the discharge is strongly alkaline having a pH of about 7 to 9, it often causes a high degree of skin damage, which delays the healing of the wound. And its local management is becoming more difficult.

[0004] In such a case, conventionally, an oily ointment is applied to the periphery of the wound, and the excreted liquid is absorbed into the excreted liquid absorber such as gauze or absorbent cotton to manage the wound. However, the oily ointment has a short duration, the drainage absorbed by the absorbent comes into contact with the skin, and the drainage has an alkaline pH as described above, and has a strong enzyme activity such as small intestinal juice, pancreatic juice, and bile. Therefore, these may damage the skin and cause skin damage.

[0005] Therefore, a collecting bag for collecting drainage from a fistula has come to be used. This collection bag is to be stuck to the periphery of the fistula using an adhesive, and acrylic and rubber-based adhesives were used.
There have been many reports of skin irritation. This is because the adhesive itself does not have a function of absorbing and retaining water, so sweat accumulates between the adhesive and the skin, and this sweat causes a rash on the skin, further peeling of the adhesive, and small intestinal fluid in that part , Pancreatic juice, bile, etc., invade and adhere, causing severe skin damage.

[0006] Furthermore, it has been attempted to mount the above-mentioned collecting bag using a skin protective agent for a stoma. However, it is assumed that a waste solution having strong alkalinity and high enzyme activity is collected. It wasn't enough.

[0007]

DISCLOSURE OF THE INVENTION The present invention absorbs a buffer which has a pH which adversely affects the skin excreted from a fistula or the like and has a high enzyme activity even if it comes into contact with the skin, thereby buffering the pH. The purpose is to obtain a skin contact member having a buffering ability that has an appropriate adhesive action and can be securely attached so as not to damage the skin by weakening the enzyme activity and not to cause skin damage. It is.

[0008]

According to the present invention, an insulting member to be adhered to a skin surface is formed by mixing a hydrophobic polymer and a hydrophilic polymer, and the hydrophobic polymer is composed of a polymer which does not form a matrix and a small amount of a matrix. Are used in combination. The hydrophilic polymer has a pH
Is formed by mixing a polymer having a buffering action with another polymer. Since the above-mentioned hydrophilic polymer having an action of buffering the pH is held in a small amount of the hydrophobic polymer forming the matrix, the excreted liquid discharged from the fistula or the like easily comes into contact with the hydrophilic polymer and is excreted. The pH of the solution is buffered to weaken the enzyme activity, so that the skin is not adversely affected and the state of application can be reliably maintained.

[0009]

BEST MODE FOR CARRYING OUT THE INVENTION This skin patch to be adhered to the skin surface is formed by uniformly mixing a hydrophobic polymer and a hydrophilic polymer. The hydrophobic polymer and the hydrophilic polymer can be mixed in an appropriate ratio depending on the case.
The ratio may be about 15 to 15, preferably about 7 to 13.

The above-mentioned hydrophobic polymer is formed by a polymer forming a matrix and a polymer not forming a matrix. The polymer forming the matrix acts to hold other mixed components, whereby the shape retention property of the skin patch member is kept excellent and the state of application to the skin can be maintained. The polymer forming the matrix is used in a relatively small amount, and is preferably about 2 to 20%, preferably about 2 to 15%, more preferably about 2 to 10% of the hydrophobic polymer.

As the hydrophobic polymer forming the matrix, a thermoplastic elastomer can be used. As the styrene-based thermoplastic elastomer, styrene / isoprene / styrene block copolymer (SIS), styrene / butadiene / styrene copolymer (SEBS), styrene-ethylene-butylene-styrene copolymer (SEBS), and the like, and polypropylene (PP), polyethylene (PE), ethylene vinyl acetate resin (EV
A), and other urethane-based thermoplastic elastomers,
Polyester-based thermoplastic elastomer, polyamide-based thermoplastic elastomer, PVC-based thermoplastic elastomer,
There are 1,2 polybutadiene-based thermoplastic elastomers and fluorine-based thermoplastic elastomers. In addition, acrylic pressure-sensitive adhesives that are cross-linked hydrophobic polymers, UV-curable pressure-sensitive adhesives,
An epoxy resin or the like can also be used.

As the hydrophobic polymer that does not form the matrix, various kinds of polymers can be used, and usually, polyisobutylene (PIB), polybutene (PB), or the like is often used.

The hydrophilic polymer includes a polymer having an action of buffering pH and other polymers.
Examples of the polymer having an action of buffering pH include, for example,
There are karaya gum, citrus pectin, carboxymethyl cellulose (CMC) and the like. Other polymers also include
Gelatin, guar gum, silium seed gum, polyacrylic acid, and other bulking agents can be used.

The content of the polymer having a function of buffering the pH in the hydrophilic polymer is preferably generally large. When the whole of the hydrophobic polymer and the hydrophilic polymer is mixed, a uniform and durable skin member is obtained. As long as is obtained, its content can be increased.

The hydrophobic polymer and the hydrophilic polymer described above are uniformly mixed well as a whole, and the mixture is rolled thinly to obtain a skinned member. The thickness of the skin-contacting member is set to an appropriate thickness depending on the application, but usually, it is often about 0.5 to 5 mm. This skin contact member is cut into an appropriate size in the affected part according to the shape and a hole corresponding to a fistula etc. is provided,
It is preferable to fix a bag for collecting drainage and the like. The surface of the skin contact member is covered with an appropriate release sheet until used.

When this is used, the bag for collecting drainage and the like can be set in place by peeling the release sheet and affixing the surface of the skin-contacting member to the affected part (periphery of the fistula or the like). This skin contact member can be guided to the collection bag without leaking the drainage discharged from the fistula in close contact with the skin surface, absorbs the discharge from the fistula at the periphery of the fistula and absorbs the drainage in the skin member. A hydrophilic polymer having a buffering action readily reacts with the
Since H is buffered and enzyme activity is weakened, the skin can be kept healthy without adversely affecting the skin.

Since the skin-forming member contains a polymer forming a matrix, the network can maintain the shape of the whole skin-forming member and maintain the adhered state without fail. Since the content is also relatively low, the drainage excreted from the fistula and the hydrophilic polymer having a buffering action can freely react,
It can be performed sufficiently without hindering the buffering action. This skin-contacting member can be effectively used for fixing a bag, an instrument, and the like for collecting various drainage after surgery in addition to the above-mentioned fistula to the skin surface.

[0018]

EXAMPLES (Example 1) Hydrophobic polymer Styrene / isoprene / styrene copolymer (SIS) 9.6% Polyisobutylene (PIB) 38.4% Tackifier 12.0% Hydrophilic polymer Karaya gum 10.0 % Citrus pectin 10.0% Extender (gelatin, etc.) 20.0% Total 100.0% The above mixture was mixed with a pressure kneader, and the mixture was rolled to form a 1 mm thick sheet and skin A member was formed.
In the above formulation, karaya gum and citrus pectin function as components having a buffering action. (The above% is
% By weight. same as below. )

(Examples 2 to 15) In the same manner as in Example 1 described above, skin-coating members were formed according to the formulations shown in Tables 1 and 2. In Tables 1 and 2, the ratio of the hydrophobic polymer to the hydrophilic polymer and the ratio of SIS to PIB in each example are shown. Table 1 also shows Example 1 above.

[0020]

[Table 1]

[0021]

[Table 2]

(Comparative Examples 1 to 3) In the same manner as in Example 1, skinning members were formed according to the formulations shown in Table 2.

(Evaluation Test) Examples 1 to 15 and Comparative Examples 1 to
For each of the skinning members of No. 3, the buffer capacity (pH buffering test), water absorption (water absorption test), initial tack (pikuma tack test), and holding power (creep test) were evaluated, and the overall evaluation was further performed. went.

(PH buffering action test) The change in pH when bile and pancreatic juice acted on each skin graft member was measured. Samples were prepared by cutting each skin material of the example and the comparative example into a square of 30 × 30 mm, and two samples were juxtaposed on a petri dish with the sticking surface side up. Bile (pH 8.18) was placed in the center of one specimen on the petri dish at 0.5.
ml of pancreatic juice (pH
8.64) was placed in 0.5 ml, and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours,
Every 4 hours, the presence or absence of absorption of bile and pancreatic juice was confirmed, and the pH was measured. The pH was measured using a HORIBA pH meter D-21T and an electrode 6261-10C. Each example and comparative example were measured three times, and the average was taken.

(Water absorption test) JIS-K6258-4.
The test was performed according to 5.2. 1. The skin contact member was cut into a size of 30 mm in diameter to obtain a test piece. Three test pieces were prepared for each example and comparative example. 2. The weight of the test piece was measured. All test pieces were placed in 3.1 liter of physiological saline (0.9% aqueous sodium chloride solution) and stored in a thermostat kept at 37 ° C. After 4.3 hours and 24 hours, the weight of the test piece was measured, and the absorption rate was measured.

(Picmatack test) Mitsuhashi method; JIS-T
The test was performed according to 9233-3.8.6 (2). 1. Specimens were cut from those having skin width of 15 mm and length of 100 mm from the skin members of Examples and Comparative Examples. 2. The surface of the adhesive disc (made of aluminum having a diameter of 50 mm and a thickness of 14 mm) of the tack meter was washed with hexane and dried at room temperature for 10 minutes. 3. The test piece was stuck on a fixed plate with a double-sided adhesive tape. 4. The start button of the pima tack tack meter was pressed, the adhesive disc was lowered, and the specimen was brought into contact with the test piece. Load 5
After contacting with 00 gf for 2.5 seconds, the film was pulled up at a speed of 30 mm / min. (Test piece temperature: 23 ° C, bonded disc temperature: 23 ° C, measurement chamber temperature: 23 ° C) The force when the test piece was separated from the adhesive disc was read. 6. For the measurement, five test pieces were sampled from the same skin member and tested, and the average value was used as the measured value.

(Creep test) JIS-Z0237-1
The test was performed according to 1. 1. Test pieces of 25 mm in width and 50 mm in length were cut from the skin-contacting members of Examples and Comparative Examples, and three test pieces were collected. 2. Place one end of the test piece on one end of the test plate washed with ethyl acetate.
A 5 × 25 mm portion was affixed so as to be in contact, and a portion not affixed was folded with the adhesive surface inside. 3. The roller was reciprocated 5 times from above the test piece and pressed. 4. The test plate to which the test piece was attached was suspended in a constant temperature bath at 40 ° C. with the test piece facing down, and warmed for 20 minutes. 5. A 500 g weight was attached to the lower end of the test piece, and the test piece was kept in a constant temperature bath at 40 ° C. for 60 minutes. 6. The offset distance of the test specimen or the time until the test specimen fell off the test plate was measured. 6. The measurement was performed on each of three test pieces.

(Evaluation of pH buffering action test) ：: The active region of digestive enzymes, pH 7.2 to 7.8, is removed within 1 hour. Δ: The active region pH 7.2 to 7.8 of the digestive enzyme is removed within 3 hours. ×: It takes 3 hours or more to escape the active region of digestive enzymes, pH 7.2 to 7.8.

(Evaluation of water absorption test) 〇: Water absorption after 300 hours is 300% or more. Δ: Water absorption after 24 hours is 200% or more. X: The water absorption after 24 hours is less than 200%.

(Evaluation of the pima tack test) ：: The initial tack was 8.0 N or more. Δ: Initial tack is less than 5.0 to 8.0 N. X: Initial tack is less than 5.0N.

(Evaluation of creep test) (Holding force) 〇: The holding time is 60 minutes or more. Δ: Holding time is less than 20 to 60 minutes. X: Holding time is less than 20 minutes. (Those with low evaluations in this test are the displacement of the skin material when applied to the skin surface,
Causes residue on skin when peeled. )

(Comprehensive evaluation) ：: When all of the above tests are の. ：: In each of the above tests, there is one △ other than ○. Δ: In each of the above tests, two Δs or one X in addition to the buffer capacity. ×: The buffer capacity is ×, or × is 2 or more, or Δ is 3 or more.

(Results) Examples 1 to 15 and Comparative Examples 1 to
Table 3 shows the evaluation and overall evaluation of each test of No. 3.

[0034]

[Table 3]

(Consideration) The skin member of the embodiment has a sufficient cushioning ability, is excellent in water absorption rate, initial tack and holding power, and is useful as a skin member having a buffering ability. You can see that. In particular, Examples 9, 12, 14,
In the case of No. 15, excellent results were obtained by comprehensive judgment. In Comparative Examples 1 to 3, sufficient buffer capacity was not obtained or the overall evaluation was low, indicating that it was not practical as a skin member having a buffer capacity.

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Claims (4)

[Claims] Claims: 1. A skin member to be attached to a fistula or the like for use, comprising a hydrophobic polymer and a hydrophilic polymer, wherein the hydrophobic polymer is a polymer that does not form a matrix and a polymer that forms a small amount of a matrix. A skin material having a buffering ability, wherein the hydrophilic polymer comprises a polymer having an action of buffering pH and another polymer. 2. The hydrophobic polymer and the hydrophilic polymer, wherein the ratio of hydrophobic polymer: hydrophilic polymer is 10: 5 to 15
2. The skin member having a buffering ability according to claim 1, wherein 3. The content of a polymer forming a matrix in the hydrophobic polymer is 20% or less.
Or a skin contact member having a buffering ability according to 2. 4. A polymer that forms a matrix in the hydrophobic polymer is a styrene-isoprene-styrene copolymer, and a polymer that does not form a matrix is polyisobutylene, and acts to buffer the pH in the hydrophilic polymer. The skin material having a buffering ability according to any one of claims 1 to 3, wherein the polymer having (i) is one or a mixture of two or more selected from karaya gum, gelatin, citrus pectin, and carboxymethyl cellulose.