High-viscosity rubber disc for medical ostomy bag

Abstract

The invention discloses a high-viscosity rubber disc for a medical ostomy bag. The high-viscosity rubber disc is mainly used for attaching an orificium fistulae. The rubber disc for the ostomy bag is formed by compounding two layers, the inner layer is a functional layer and is mainly used for being attached to an orificium fistulae and making contact with the skin, the outer layer is an auxiliary layer and is mainly used for shaping, assisting in bonding and fixing a liquid receiving bag, the outer edge of the outer layer exceeds the inner layer by 1-2 cm, and the inner edge of the outer layer is located on the front half section, close to the circle center, of the inner layer. And the two layers have functions and are stably combined through hot-pressing compounding and chemical reaction between the two layers. The plastic plate is firmly combined with the skin, feels comfortable, can quickly absorb the secretion of the orificium fistulae, has heat sensitivity, and can be easily peeled off from the skin when being heated to a certain temperature.

Description

TECHNICAL FIELD

[0001] The present application relates to a preparation method of a colostomy bag gel, and particularly to a preparation method of a colostomy bag gel with excellent adhesion, liquid absorption and comfort. BACKGROUND

[0002] "Colostomy" is caused by diseases of the digestive system or urinary system, which requires surgical treatment to separate the intestinal tract, and to lead one end of the intestinal tract out of the body surface (anus or urethra to the abdominal wall) to form an opening, so as to achieve the purpose of reducing pressure on the intestinal tract, reducing obstruction, protecting the anastomosis or damage of the distal intestinal tract, and promoting the recovery of intestinal and urinary tract diseases.

[0003] The colostomy patient changes the defecation mode due to surgical intervention, loses the control function of the sphincter, and needs to wear a colostomy bag on the waist to collect the excrement. The colostomy bag body includes one-piece and two-piece, but no matter which form is used, a biological gel base plate is needed to adhere to the skin to fix the colostomy bag and achieve functionality. Since it is close to the skin and the wound, it is very important to meet the requirements. The base plate not only needs to be able to fix the colostomy bag, play a very good long-term adhesion to the skin and fix the bag body, but also needs to absorb wound secretions, permeate urine, prevent corrosion, and protect the skin from the effects of excrement. In addition, it should be friendly to the skin, avoid irritating the skin, be easy to remove while having high adhesion, and other features.

[0004] The current colostomy bag gel plate has various formulations, including single-layer and double-layer modes, flat and concave forms, and spiral and pliable winch modes. Different modes use different adhesive systems. Foreign brands include ConvaTec and Coloplast, and domestic brands include Henkel. The winch used by all of them can achieve stable adhesion to the skin and long-term use. However, after use, it is difficult to remove from the skin due to the high adhesion, which can easily cause pulling on the wound.

[0005] In view of the above problems, the present application develops a new double-layer gel plate. The double layers are stably combined through reaction, the inner layer plays the role of adhesion and other functions, and the outer layer assists adhesion and maintains sufficient shrinkage of the inner layer through cohesion to further protect the wound or leak-proof strip and achieve good protection. At the same time, the base plate can be easily peeled off from the skin through heating to avoid secondary damage. The gel plate material can also be prepared into a flat or concave surface by a mold to adapt to different colostomy bag designs. SUMMARY

[0006] The present application aims to solve at least one of the problems existing in the prior art. To this end, the present application provides a double-layer gel plate which can stably adhere to the skin, maintain sufficient shape stability, and be easily peeled off by heating.

[0007] A high-adhesion adhesive disc for medical use, which is composed of an outer layer and an inner layer of double-layer adhesive material, the inner layer being a disc and the outer layer being a concentric ring of the inner layer, the thickness of the inner layer being between 0.5-1mm and the thickness of the outer layer being between 0.2-0.5mm, the outer layer being covered on the inner layer with its inner edge within the first half radius of the inner disc near the center and its outer edge extending 1-2.5cm beyond the outer edge of the inner layer, Further, the inner layer directly adheres to the skin, and a hole can be made at the center to expose and tightly wrap the fistula, and the outer layer adheres to the skin beyond the inner layer to assist the inner layer in maintaining stable shape and together with the inner layer tightly adhering to the skin; Further, reactive connectors A and B are arranged between the inner and outer layers, and the two layers are stably bonded through heat pressing and the chemical action of the connectors. Further, the inner layer has temperature sensitivity, and at normal temperature it can be stably and firmly adhered to the skin, while when heated to a certain temperature, it can lose part of the adhesion and be easily peeled off from the skin.

[0008] Further, the thickness of the inner layer is between 0.5-1mm and the thickness of the outer layer is between 0.2-0.5mm.

[0009] Further, the radius of the inner disc is set according to medical standards.

[0010] Further, the hole of the inner disc can be set to several different radii of circles according to the needs of the fistula.

[0011] Further, the inner layer is composed of different molecular weight thermoplastic resin, tackifying resin, biomass adhesive, water absorbing agent and heat-sensitive resin, and the outer layer is composed of different molecular weight thermoplastic resin, tackifying resin, solid resin and heat-sensitive resin, and the joint surface of the double layers is coated with connector component A and connector component B. Further, the proportion of the substances of the inner layer is as follows in mass fraction: Thermoplastic resin: 100 Tackifying resin: 30-50 Biomass adhesive: 10-20 Water absorbing agent: 3-8 Heat-sensitive resin: 5-10 The proportion of the substances of the outer layer is as follows in mass fraction: Thermoplastic resin: 100 Tackifying resin: 10-20 Solid resin: 10-20 Water absorbing agent: 1-3 Heat-sensitive resin: 5-15 Further, the connecting component A is a multi-arm polyethylene glycol aldehyde solution with a mass concentration of 3-12%, and the connecting component B is a multi-arm polyethylene glycol amine solution with a mass concentration of 3-12%, which are respectively coated on the inner layer and the outer layer contact surface.

[0012] Further, the multi-arm aldehyde polyethylene glycol is between 2 arms and 8 arms, and the molecular weight is between 4000-10000.

[0013] Further, the thermoplastic resin includes styrene-based elastomer polystyrene-polyisoprene-polystyrene block copolymer, polystyrene-polybutadiene-polystyrene block copolymer, polystyrene-poly(ethylene-butylene)-polystyrene block copolymer, polystyrene-poly(ethylene-propylene)-polystyrene block copolymer, thermoplastic polyurethane elastomer, ethylene, propylene and non-conjugated diene terpolymer elastomer, and the molecular weight is between 150000-400000.

[0014] Further, the tackifying resin is polybutadiene resin and polyisobutylene resin with different molecular weights.

[0015] Further, for the inner layer, the tackifying resin has a molecular weight between 2000-200000; the resin with a molecular weight between 2000-60000 accounts for 20-60% of the total tackifying resin mass, preferably 30-50%; the resin with a molecular weight between 2000-10000 accounts for 10-25% of the total tackifying resin mass, preferably 15-25%.

[0016] Further, for the outer layer, the tackifying resin has a molecular weight between 2000-300000; the resin with a molecular weight between 2000-60000 accounts for 15-40% of the total tackifying resin mass, preferably 20-30%; the resin with a molecular weight between 2000-10000 accounts for 5-12% of the total tackifying resin mass, preferably 5-8%.

[0017] Further, the biomass colloid is one or a combination of gelatin or pectin, wherein the gelatin can be skin gelatin or bone gelatin, and the pectin can be orange pectin, apple pectin, guar gum.

[0018] Further, the heat-sensitive resin is a resin that will cause the molecular chain to move more intensely and soften when the temperature is increased, and the melting point is between 50-70 o C, and a poly-caprolactone or polyolefin elastomer resin POE with a certain molecular weight can be selected.

[0019] Further, the water absorbing agent is one or a combination of carboxymethyl cellulose and sodium polyacrylate in any proportion, and the carboxymethyl cellulose is preferred.

[0020] Furthermore, the solid resin is one of vinyl acetate-ethylene copolymer, ethylene-vinyl alcohol copolymer, and ethylene-acrylic acid copolymer; preferably, it is ethylene-vinyl alcohol copolymer with a molecular weight between 80,000 and 200,000.

[0021] Furthermore, the processing technology of the rubber disc is as follows: the inner layer and the outer layer are respectively obtained by compounding, screw extrusion and first rolling to obtain inner and outer layer sheets. After coating the bonding surface of the sheets with connecting component A and connecting component B, the double-layer composite sheet is obtained by second rolling.

[0022] Furthermore, the processing technology of the rubber disc is as follows: the inner layer and the outer layer are respectively obtained by mixing, screw extrusion and rolling of the compound material separately to obtain inner and outer layer sheets. After cutting, the connecting component A and connecting component B are coated on the bonding surface of the two sheets, and then the double-layer composite is achieved by hot pressing.

[0023] Furthermore, under heating conditions, the evaporation of water between components A and B results in a Schiff base reaction between aldehyde and amino groups to achieve cross-linking.

[0024] Furthermore, the processing technology of the rubber disc is as follows: the extrusion temperature of the inner layer is 120-140°C. o C; The extrusion temperature of the outer layer is 130-160℃. o C, The temperature of the roller is between 80-110°C. o The temperature between C and 140-160°C is required for hot pressing. o Between C, the pressure is 2-5 MPa, and the residence time is 15-30 s.

[0025] Furthermore, the adhesive disc can be formed into a convex disc by hot pressing with a concave mold after lamination.

[0026] Furthermore, after the adhesive disc adheres to human skin, the adhesion force is between 3-6 KN / m. Under a vertical load of 2 kg, it remains adhered to the skin for 30 days without falling off; under a vertical load of 3 kg, it remains adhered to the skin for 15 days without falling off.

[0027] Furthermore, the maximum water absorption capacity of the rubber disc is between 3-10 g / g rubber disc, and the water absorption rate is between 0.1-0.5 ml / h.

[0028] Furthermore, the rubber disc is corrosion resistant and does not corrode or deform under acidic conditions of pH=2 for 24 hours.

[0029] Furthermore, the rubber disc has a certain degree of shrinkage, and the inner layer can shrink according to the shape due to the cohesive force of the outer layer, thereby ensuring good fistula protection. Even if the shape of the fistula changes to a certain extent, it can adapt to the shape.

[0030] Furthermore, if the adhesive tape is too tightly bonded to be easily removed, it can be heated to 50 degrees Celsius on the surface of the tape. o C helps peel the rubber disc off the skin.

[0031] Furthermore, the adhesive tray can be adapted to various one-piece and two-piece ostomy bags.

[0032] Furthermore, the beneficial effects of this invention patent are as follows: on the basis of good performance of a single layer, the synergistic effect between the two layers achieves excellent adhesion, liquid absorption, and shaping effects; the tight bond between the two layers ensures that the rubber disc does not separate under long-term stress, thus ensuring that it can bear weight for a long time without deformation or falling off during use; the winch also overcomes the problem of difficulty in removing the skin after it is tightly adhered to it, and can be peeled off without residue by heating the outer surface. Attached Figure Description

[0033] Figure 1 This is a plan view of the rubber disc prepared in Example 1; Figure 2 This is a plan view of the rubber disc prepared in Example 2. Detailed Implementation

[0034] The implementation schemes of this application will be described in detail below with reference to the embodiments. However, those skilled in the art will understand that the following embodiments are only used to illustrate this application and should not be regarded as limiting the scope of this application. Example 1

[0035] A high-viscosity adhesive disc for medical ostomy bags, such as Figure 1 As shown, it is composed of two layers. The inner layer 1-1 is a disk, the outer layer 1-2 is a ring, and 1-3 is the shape after the two layers are superimposed. The two layers share the same center. The diameter of the inner layer 1-3-1 is 10cm. The outer edge of the outer layer 1-3-2 extends 2cm beyond the outer edge 1-3-3 of the inner layer 1-3-1. The inner edge of the outer layer 1-3-2 is 3cm away from the center.

[0036] The outer layer has a thickness of 0.3 mm, and the inner layer has a thickness of 0.7 mm.

[0037] The inner layer is composed of thermoplastic resin, tackifying resin, biomass colloid, water absorbent, and heat-sensitive resin; The proportions of the inner layer's substances, expressed in parts by mass, are as follows: Thermoplastic resin: 100 Tackifying resin: 45 Biomass colloids: 15 Water absorbent: 6 Thermosensitive resin: 8 The outer layer is composed of thermoplastic resins of different molecular weights, tackifying resins, solid resins, and heat-sensitive resins; The proportions of the outer layer of material, expressed in parts by mass, are as follows: Thermoplastic resin: 100 Tackifying resin: 16 Solid resin: 15 Water absorbent: 2 Thermosensitive resin: 10 The connecting component A is a 6% (w / w) four-arm polyethylene glycol aldehyde solution; the connecting component B is an 8% (w / w) four-arm polyethylene glycol amine solution. The molecular weight of the four-arm polyethylene glycol aldehyde is 6000, and the molecular weight of the four-arm polyethylene glycol amine is 8000. Connecting component A is coated on the outer surface of the inner layer, and connecting component B is coated on the inner surface of the outer layer. Components A and B are in contact with each other.

[0038] For the inner layer: The thermoplastic resin is a polystyrene-polyisoprene-polystyrene block copolymer with a molecular weight of 260,000.

[0039] The tackifying resin is polyisobutylene resin with molecular weights of 180,000, 40,000, and 2,000, respectively, in a mass ratio of 2:1:0.5.

[0040] The biomass colloid is a combination of gelatin and apple pectin in a mass ratio of 1:1.

[0041] The heat-sensitive resin is a polyolefin elastomer resin (POE) with a melting point of 65°C. o C.

[0042] The absorbent is carboxymethyl cellulose.

[0043] For the outer layer: The thermoplastic resin is a polystyrene-poly(ethylene-butene)-polystyrene block copolymer with a molecular weight of 300,000.

[0044] The tackifying resin is polybutadiene resin with molecular weights of 200,000, 60,000, and 2,000, respectively, in a mass ratio of 10:2:1.

[0045] The solid resin is an ethylene-vinyl alcohol copolymer with a molecular weight of 64,000.

[0046] The thermosensitive resin is polycaprolactone, with a melting point of 62°C. o C.

[0047] The absorbent is carboxymethyl cellulose.

[0048] The processing technology of the rubber disc is as follows: The inner layer composite material is first mixed into a homogeneous mixture by intensive mixing at a mixing temperature of 120°C. o After 10 minutes of intensive mixing, the temperature is raised to 130°C.o C. Continue mixing for 10 minutes. The biomass colloid is added to 40% water by mass, left to stand for 20 minutes, and then added to the mixing process. The outer composite material is first mixed into a homogeneous mixture by intensive mixing at a mixing temperature of 130°C. o After 10 minutes of intensive mixing, the temperature is raised to 140°C. o C continues to refine for another 10 minutes; The inner layer composite material and the outer layer composite material are fed into two twin-screw extruders respectively, at a speed of 130... o C and 150 o C is used for extrusion; The inner and outer composite materials were respectively fed into 90 o After the first roller, sheets of 0.8 mm and 0.4 mm are obtained. Then, the inner and outer composite materials are coated with bonding component A and bonding component B respectively through the coating roller device. The inner and outer sheets are hot-pressed together at a temperature of 145°C. o C, pressure is 2.5MPa, residence time is 20s.

[0049] The performance of the rubber disc is as follows: After the adhesive disc adheres to human skin, the adhesion force is 5.2 KN / m. It can adhere to the skin for 42 days under a load of 2 kg before falling off, and under a vertical load of 3 kg, it can adhere to the skin for 22 days before falling off.

[0050] The maximum water absorption capacity of the rubber disc is 7.2 g / g of rubber disc, and the water absorption rate is 0.45 ml / h.

[0051] The rubber disc is corrosion resistant and does not corrode or deform under acidic conditions of pH=2 for 24 hours.

[0052] The rubber disc is heated to 45-50 degrees Celsius on its upper surface, causing the biomass colloid to be entirely heated. o After C, peeling can be achieved.

[0053] Example 2 A high-viscosity adhesive disc for medical ostomy bags, such as Figure 2 As shown, it is composed of two layers. The inner layer 2-1 is a disk, the outer layer 2-2 is a ring, and 2-3 is the shape after the two layers are superimposed. The two layers share the same center. The diameter of the inner layer 2-3-1 is 10cm. The outer edge of the outer layer 2-3-2 extends 1.5cm beyond the outer edge 1-3-3 of the inner layer 1-3-1. The inner edge of the outer layer 1-3-2 is 2.5cm away from the center.

[0054] The outer layer has a thickness of 0.4 mm, and the inner layer has a thickness of 0.5 mm.

[0055] The inner layer is composed of thermoplastic resin, tackifying resin, biomass colloid, water absorbent, and heat-sensitive resin; The proportions of the inner layer's substances, expressed in parts by mass, are as follows: Thermoplastic resin: 100 Tackifying resin: 48 Biomass colloids: 12 Water absorbent: 5 Thermosensitive resin: 6 The outer layer is composed of thermoplastic resins of different molecular weights, tackifying resins, solid resins, and heat-sensitive resins; The proportions of the outer layer of material, expressed in parts by mass, are as follows: Thermoplastic resin: 100 Tackifying resin: 14 Solid resin: 18 Water absorbent: 3 Thermosensitive resin: 12 The connecting component A is a 6% (w / w) four-arm polyethylene glycol aldehyde solution; the connecting component B is a 10% (w / w) four-arm polyethylene glycol amine solution. The molecular weight of both the four-arm polyethylene glycol aldehyde and the four-arm polyethylene glycol amine is 8000. Connecting component A is coated on the outer surface of the inner layer, and connecting component B is coated on the inner surface of the outer layer. Components A and B are in contact with each other.

[0056] For the inner layer: The thermoplastic resin is a polystyrene-polyisoprene-polystyrene block copolymer with a molecular weight of 180,000.

[0057] The tackifying resin is polybutadiene resin. For the inner layer, three resins with different molecular weights are used, with molecular weights of 120,000, 60,000, and 3,000, respectively, in a mass ratio of 2:1:1.

[0058] The biomass colloid is a combination of gelatin and orange pectin in a mass ratio of 2:1.

[0059] The thermosensitive resin is polycaprolactone, with a melting point of 62°C. o C.

[0060] The absorbent is carboxymethyl cellulose.

[0061] For the outer layer: The thermoplastic resin is a polystyrene-poly(ethylene-propylene)-styrene block copolymer with a molecular weight of 320,000.

[0062] The tackifying resin is polybutadiene resin, which is formulated with three resins of different molecular weights, namely 240,000, 50,000, and 6,000, in a mass ratio of 8:3:1.

[0063] The heat-sensitive resin is a polyolefin elastomer resin (POE) with a melting point of 65°C. o C.

[0064] The solid resin is a vinyl acetate-ethylene copolymer with a molecular weight of 85,000.

[0065] The absorbent is carboxymethyl cellulose.

[0066] The processing technology of the rubber disc is as follows: The inner layer composite material is first mixed into a homogeneous mixture by intensive mixing at a mixing temperature of 110°C. o After 10 minutes of intensive mixing, the temperature will rise to 125°C. o C. Continue mixing for 10 minutes. The biomass colloid is added to 35% water by mass, left to stand for 20 minutes, and then added to the mixing process. The outer composite material is first mixed into a homogeneous mixture by intensive mixing at a mixing temperature of 130°C. o After 10 minutes of intensive mixing, the temperature is raised to 140°C. o C continues to refine for another 10 minutes; The inner layer composite material and the outer layer composite material are respectively fed into two twin-screw extruders at a speed of 125. o C and 150 o C is used for extrusion; The inner and outer composite materials were each fed with 100... o After the first roller, sheets of 0.6 mm and 0.5 mm are obtained. Then, the inner and outer composite materials are coated with bonding component A and bonding component B respectively through the coating roller device. The inner and outer sheets are hot-pressed together at a temperature of 150°C. o C, pressure is 3.0 MPa, residence time is 15 s.

[0067] After the adhesive disc adheres to human skin, the adhesion force is 5.1 KN / m. It can adhere to the skin for 45 days under a load of 2 kg before falling off, and under a vertical load of 3 kg, it can adhere to the skin for 24 days before falling off.

[0068] The maximum water absorption capacity of the rubber disc is 6.1 g / g of the disc, and the water absorption rate is 0.34 ml / h.

[0069] The rubber disc is corrosion resistant and does not corrode or deform under acidic conditions of pH=2 for 24 hours.

[0070] The rubber disc is heated to 45-50 degrees Celsius on its upper surface, causing the biomass colloid to be entirely heated. o After C, peeling can be achieved.

[0071] Example 3 A high-viscosity adhesive disc for medical ostomy bags is composed of two layers: an inner disc and an outer concentric ring. The outer layer is 0.3 mm thick and the inner layer is 0.7 mm thick. The inner layer has a diameter of 12 cm, and the outer edge of the outer layer extends 1.8 cm beyond the outer edge of the inner layer. The inner edge of the outer layer is 2.8 cm away from the center of the inner layer.

[0072] The inner layer is composed of thermoplastic resin, tackifying resin, biomass colloid, water absorbent, and heat-sensitive resin; The proportions of the inner layer's substances, expressed in parts by mass, are as follows: Thermoplastic resin: 100 Tackifying resin: 32 Biomass colloids: 18 Water absorbent: 6 Thermosensitive resin: 8 The outer layer is composed of thermoplastic resins of different molecular weights, tackifying resins, solid resins, and heat-sensitive resins; The proportions of the outer layer of material, expressed in parts by mass, are as follows: Thermoplastic resin: 100 Tackifying resin: 16 Solid resin: 15 Water absorbent: 2 Thermosensitive resin: 10 The connecting component A is an 8% (w / w) eight-arm polyethylene glycol aldehyde solution; the connecting component B is a 10% (w / w) four-arm polyethylene glycol amine solution. The molecular weight of the eight-arm polyethylene glycol aldehyde is 8000, and the molecular weight of the four-arm polyethylene glycol amine is 4000. Connecting component A is coated on the outer surface of the inner layer, and connecting component B is coated on the inner surface of the outer layer. Components A and B are in contact with each other.

[0073] For the inner layer: The thermoplastic resin is a thermoplastic polyurethane elastomer with a molecular weight of 320,000.

[0074] The tackifying resin is polyisobutylene resin. For the inner layer, it is a combination of three resins with different molecular weights: 160,000, 45,000, and 2,400, in a mass ratio of 2.5:0.5:1.

[0075] The biomass colloid is gelatin.

[0076] The thermosensitive resin is polycaprolactone, with a melting point of 62°C. o C.

[0077] The absorbent is carboxymethyl cellulose.

[0078] For the outer layer: The thermoplastic resin is a polystyrene-poly(ethylene-propylene)-styrene block copolymer with a molecular weight of 320,000.

[0079] The tackifying resin is polybutadiene resin, which is formulated with three resins of different molecular weights, namely 240,000, 50,000, and 6,000, in a mass ratio of 8:3:1.

[0080] The solid resin is an ethylene-acrylic acid copolymer with a molecular weight of 120,000.

[0081] The thermosensitive resin is polycaprolactone, with a melting point of 62°C. o C.

[0082] The absorbent is sodium polyacrylate resin.

[0083] The processing technology of the rubber disc is as follows: The inner layer composite material is first mixed into a homogeneous mixture by intensive mixing at a mixing temperature of 120°C. o After 10 minutes of intensive mixing, the temperature will rise to 135°C. o C. Continue mixing for 10 minutes. The biomass colloid is added to 40% water by mass, left to stand for 20 minutes, and then added to the mixing process. The outer composite material is first mixed into a homogeneous mixture by intensive mixing at a mixing temperature of 135°C. o After 10 minutes of intensive mixing, the temperature will rise to 145°C. o C continues to refine for another 10 minutes; The inner layer composite material and the outer layer composite material are fed into two twin-screw extruders respectively, at a speed of 130... o C and 150 o C is used for extrusion; The inner and outer composite materials were each fed with 100... o After the first roller, sheets of 0.8 mm and 0.35 mm are obtained. Then, the inner and outer composite materials are coated with bonding component A and bonding component B respectively through the coating roller device. The inner and outer sheets are hot-pressed together at a temperature of 155°C. o C, pressure is 3.5 MPa, residence time is 15 s.

[0084] After the adhesive disc adheres to human skin, the adhesion force is 4.3 KN / m. It can adhere to the skin for 32 days under a load of 2 kg before falling off, and under a vertical load of 3 kg, it can adhere to the skin for 16 days before falling off.

[0085] The maximum water absorption capacity of the rubber disc is 6.4 g / g of the disc, and the water absorption rate is 0.36 ml / h.

[0086] The rubber disc is corrosion resistant and does not corrode or deform under acidic conditions of pH=2 for 24 hours.

[0087] The rubber disc is heated to 45-50 degrees Celsius on its upper surface, causing the biomass colloid to be entirely heated. o After C, peeling can be achieved.

[0088] Comparative Example 1: Referring to Example 1, the formulations of the inner and outer layers remain unchanged, but the thickness is adjusted so that the outer layer thickness is 0.2 mm and the inner layer thickness is 0.8 mm. The properties are as follows: After the adhesive disc adheres to human skin, the adhesion force is 3.2KN / m, and it can continuously adhere to the skin for 42 days under a load of 2 kg.

[0089] The maximum water absorption capacity of the rubber disc is 7.2 g / g of rubber disc, and the water absorption rate is 0.45 ml / h.

[0090] The rubber disc is corrosion resistant and does not corrode or deform under acidic conditions of pH=2 for 24 hours.

[0091] The rubber disc is heated to 45-50 degrees Celsius on its upper surface, causing the biomass colloid to be entirely heated. o After C, peeling can be achieved.

[0092] Comparative Example 2: Referring to Example 1, the formula ratio of the inner layer material was adjusted, while other aspects remained unchanged. The inner layer material became: The proportions of the inner layer's substances, expressed in parts by mass, are as follows: Thermoplastic resin: 100 Tackifying resin: 25 Biomass colloids: 10 Water absorbent: 4 Thermosensitive resin: 10 The performance of the rubber disc is as follows: After the adhesive disc adheres to human skin, the adhesion force is 1.4 KN / m. It can adhere to the skin for 8 days under a load of 2 kg before falling off; under a vertical load of 3 kg, it can adhere to the skin for 16 hours before falling off.

[0093] The maximum water absorption capacity of the rubber disc is 6.3 g / g of the disc, and the water absorption rate is 0.44 ml / h.

[0094] The rubber disc is corrosion resistant and does not corrode or deform under acidic conditions of pH=2 for 24 hours.

[0095] The rubber disc is heated to 45-50 degrees Celsius on its upper surface. o After C, peeling can be achieved.

[0096] Compared to the example, the comparative example has a reduced amount of the main adhesive material in the inner layer, resulting in a significant decrease in adhesion and making stable adhesion impossible.

[0097] Comparative Example 3: Referring to Example 1, the formula ratio of the outer layer material was adjusted, while other aspects remained unchanged. The outer layer material became: The proportions of the inner layer's substances, expressed in parts by mass, are as follows: Thermoplastic resin: 100 Tackifying resin: 10 Biomass colloids: 10 Water absorbent: 4 Thermosensitive resin: 10 The performance of the rubber disc is as follows: After the adhesive disc adheres to human skin, the adhesion force is 4.8 KN / m. It can adhere to the skin for 12 days under a load of 2 kg; under a vertical load of 3 kg, it will adhere to the skin for 2 days before falling off.

[0098] The maximum water absorption capacity of the rubber disc is 6.3 g / g of the disc, and the water absorption rate is 0.44 ml / h.

[0099] The rubber disc is corrosion resistant and does not corrode or deform under acidic conditions of pH=2 for 24 hours.

[0100] The rubber disc is heated to 45-50 degrees Celsius on its upper surface, causing the biomass colloid to be entirely heated. o After C, peeling can be achieved.

[0101] Compared to the embodiment, the main adhesive material of the outer layer in the comparative example is reduced. Although the outer layer is not the main adhesive unit, its auxiliary adhesive effect is significant. When the adhesiveness is reduced, although the adhesive force is not reduced much, the continuous adhesive ability is significantly reduced and it is easy to deform.

[0102] Comparative Example 4: Referring to Example 3, no heat-sensitive resin was added to either the outer or inner layer formulation system, and there were no other changes.

[0103] The properties of the resulting rubber disc are as follows: After the adhesive disc adheres to human skin, the adhesion force is 4.8 KN / m. It can adhere to the skin for 41 days under a load of 2 kg before falling off, and under a vertical load of 3 kg before falling off after 22 days.

[0104] The maximum water absorption capacity of the rubber disc is 6.8 g / g of rubber disc, and the water absorption rate is 0.42 ml / h.

[0105] The rubber disc is corrosion resistant and does not corrode or deform under acidic conditions of pH=2 for 24 hours.

[0106] The rubber disc is heated to a temperature of 45°C on its upper surface, which is equivalent to the total temperature of the biomass colloid. o After C, it cannot be detached and its adhesiveness increases, but the biomass colloid is generally soft.

[0107] Compared to the previous example, since there is no heat-sensitive resin, the proportion of tackifying resin increases, resulting in an overall increase in viscosity. However, the heat-release effect is lost, and the morphological stability deteriorates.

[0108] Comparative Example 5: Referring to Example 3, the outer and inner layers are completely identical in shape, the inner and outer edges are aligned, and there are no other changes.

[0109] The properties of the resulting rubber disc are as follows: After the adhesive disc adheres to human skin, the adhesion force is 4.3 KN / m. It can adhere to the skin for 18 days under a load of 2 kg before falling off, and under a vertical load of 3 kg before falling off after 9 days.

[0110] The maximum water absorption capacity of the rubber disc is 6.2 g / g of rubber disc, and the water absorption rate is 0.35 ml / h.

[0111] The rubber disc is corrosion resistant and does not corrode or deform under acidic conditions of pH=2 for 24 hours.

[0112] The rubber disc is heated to 45-50 degrees Celsius on its upper surface, causing the biomass colloid to be entirely heated. o After C, peeling can be achieved.

[0113] Compared to the previous example, since the outer layer does not function independently of the inner layer, the synergy is insufficient, resulting in a weakened sustained adhesion effect even though the adhesion force is not reduced.

Claims

1. A high-adhesion adhesive disc for a medical ostomy bag, comprising an outer and inner layer of colloidal material, wherein the inner layer is a disc and the outer layer is a concentric ring of the inner layer; the thickness of the inner layer is between 0.5-1 mm, and the thickness of the outer layer is between 0.2-0.5 mm; the outer layer covers the inner layer, with its inner edge located within the first half radius of the inner disc's radius closest to the center; the outer edge extends 1-2.5 cm beyond the outer edge of the inner layer. Its characteristics also include: The inner layer adheres directly to the skin, and an opening can be made at the center to expose and tightly wrap the fistula. The outer layer extends beyond the inner layer and adheres to the skin to help the inner layer maintain its shape and stability, and together with the inner layer, they play the role of tightly adhering to the skin. Reactive binders A and B are provided between the inner and outer layers, and the two layers achieve stable interlayer adhesion through hot pressing and the chemical action of the binders; The inner colloid is temperature sensitive. It can adhere stably and firmly to the skin at room temperature, but when heated to a certain temperature, it can lose some of its adhesiveness and easily peel off from the skin.

2. A high-adhesion adhesive tray for a medical ostomy bag as described in claim 1, characterized in that, The inner layer is composed of thermoplastic resins of different molecular weights, tackifying resins, biomass colloids, water absorbents, and heat-sensitive resins; the outer layer is composed of thermoplastic resins of different molecular weights, tackifying resins, solid resins, and heat-sensitive resins; the bonding surfaces of the two layers are coated with connecting component A and connecting component B. That The features also include: The proportions of the inner layer's substances, expressed in parts by mass, are as follows: Thermoplastic resin: 100 Tackifying resin: 30-50 Biomass colloids: 10-20 Water absorbent: 3-8 Heat-sensitive resin: 5-10 The proportions of the outer layer of material, expressed in parts by mass, are as follows: Thermoplastic resin: 100 Tackifying resin: 10-20 Solid resin: 10-20 Water absorbent: 1-3 Heat-sensitive resin: 5-15 Its characteristics also include: The connecting component A is a multi-arm polyethylene glycol aldehyde solution with a mass concentration of 3-12%, and the connecting component B is a multi-arm polyethylene glycol amine solution with a mass concentration of 3-12%. Both are coated on the contact surfaces of the inner and outer layers before the double-layer composite.

3. A high-adhesion adhesive tray for a medical ostomy bag as described in claim 1, characterized in that, The thermoplastic resin includes styrene-based elastomers such as polystyrene-polyisoprene-polystyrene block copolymers, polystyrene-polybutadiene-polystyrene block polymers, polystyrene-poly(ethylene-butene)-polystyrene block copolymers, polystyrene-poly(ethylene-propylene)-polystyrene block copolymers, thermoplastic polyurethane elastomers, and ethylene, propylene, and non-conjugated diene terpolymer elastomers, with molecular weights between 150,000 and 400,000.

4. A high-viscosity adhesive tray for a medical ostomy bag as described in claim 1, characterized in that, The tackifying resin is polybutadiene resin or polyisobutylene resin with different molecular weights; in the inner layer, the molecular weight is between 2,000 and 200,000; the content of resin with a molecular weight between 2,000 and 60,000 is between 20% and 60% of the total tackifying resin mass; the content of resin with a molecular weight between 2,000 and 10,000 is between 10% and 25% of the total tackifying resin mass; in the outer layer, the molecular weight is between 2,000 and 300,000; the content of resin with a molecular weight between 2,000 and 60,000 is between 15% and 40% of the total tackifying resin mass; and the content of resin with a molecular weight between 2,000 and 10,000 is between 5% and 12% of the total tackifying resin mass.

5. A high-adhesion adhesive tray for a medical ostomy bag as described in claim 1, characterized in that, The biomass colloid is one or more combinations of gelatin or pectin.

6. A high-viscosity adhesive tray for a medical ostomy bag as described in claim 1, characterized in that, The thermosensitive resin is a resin whose molecular chain movement intensifies and softens when the temperature is increased, and its melting point is between 50-70°C.

7. A high-adhesion adhesive tray for a medical ostomy bag as described in claim 1, characterized in that, The absorbent is one or a combination of two of carboxymethyl cellulose and sodium polyacrylate in any proportion.

8. A high-viscosity adhesive tray for a medical ostomy bag as described in claim 1, characterized in that, The solid resin is one of vinyl acetate-ethylene copolymer, ethylene-vinyl alcohol copolymer, and ethylene-acrylic acid copolymer, with a molecular weight between 80,000 and 200,000.

9. A high-viscosity adhesive tray for a medical ostomy bag as described in claim 1, characterized in that, The processing technology of the rubber disc is as follows: the inner layer and the outer layer are respectively obtained by mixing, screw extrusion and rolling of the compound material separately to obtain inner and outer layer sheets. After cutting, the connecting component A and connecting component B are coated on the inner surface where the two sheets are joined, and then the double-layer composite is achieved by hot pressing.

10. A high-viscosity adhesive tray for a medical ostomy bag as described in claim 1, characterized in that, The processing technology of the rubber disc is as follows: the extrusion temperature of the inner layer is 120-140℃; the extrusion temperature of the outer layer is 130-160℃; the temperature of the roller is between 80-110℃; the temperature of hot pressing is between 140-160℃; the pressure is 2-5MPa; and the residence time is 15-30s.

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