Diagnosis and treatment integrated ostomy bag with customizable adhesive force and preparation method thereof

Abstract

The invention provides a diagnosis and treatment integrated ostomy bag with customizable adhesive force, which comprises an ostomy bag body convenient for a medical worker to wear on a hand, an adhesive layer for adhering pollutants, pathogens, impurities and other harmful substances, and a bag mouth base plate arranged between the adhesive layer and the ostomy bag body and used for connecting and rotating, the adhesion force and the wet environment adaptability of the adhesion layer can be customized according to the skin state of a patient, the adhesion layer is made of a material with good biocompatibility and antibacterial property, a temperature-sensitive color-changing material is doped in the adhesion layer, and a bottom valve playing a sealing role is arranged at the tail end of the lower portion of the ostomy bag body. The adhesive force can be customized through micro-nano structure design according to the skin state of a patient, the functions of temperature monitoring and skin wound healing can be achieved, and good biocompatibility and antibacterial property are achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an integrated diagnosis and treatment ostomy bag with customizable adhesion and a preparation method thereof. Background Art

[0002] With the advancement of medical technology, ostomy surgery has become a common treatment for patients with malignant tumors, inflammatory bowel disease, neurogenic diseases, congenital abnormalities or trauma. Such surgery usually requires the opening of a stoma in the abdomen, including an intestinal or urethral stoma, to excrete the body's metabolites. Regardless of the type of stoma or the way it is managed, the patient's postoperative recovery and rehabilitation depends largely on avoiding complications at the stoma site and the skin around it as much as possible. This requires relying on high-performance ostomy bag equipment. At present, there are some patent reports on improving the performance of ostomy bags at home and abroad. For example, adjustable and highly adhesive ostomy bags are improved by improving the material design of the adhesive surface and the adhesive composition such as medical silicone, polyurethane glue, etc.; self-healing adhesive ostomy bags, self-healing materials are usually composed of polymers, which can restore their original adhesion ability through molecular recombination after a slight scratch on the surface; smart ostomy bags, using temperature-sensitive, moisture-sensitive or pressure-sensitive materials, can automatically adjust their adhesion according to environmental conditions.

[0003] Although there have been some progress in technological development, the existing ostomy bags still have some technical defects, which are specifically manifested in the following aspects: 1. Adhesion is prone to failure in a humid environment, and the adhesion cannot be customized according to the patient's skin condition: The existing ostomy bags have poor adhesion in a humid environment, especially under the influence of the patient's sweat or excrement, and the adhesion is prone to failure. In addition, the existing equipment cannot customize the adhesion according to the specific condition of the patient's skin. 2. Single function: Most existing ostomy bags only have basic excrement collection functions, lack additional diagnostic and treatment functions, and cannot effectively monitor and feedback the patient's postoperative recovery. 3. Poor biocompatibility and antibacterial properties: The biocompatibility and antibacterial properties of existing ostomy bag materials need to be improved. During long-term use, due to the continuous stimulation of excrement, patients often suffer from skin problems such as infection or dermatitis.

[0004] Therefore, the present invention aims to overcome the above-mentioned deficiencies in the prior art and propose an innovative ostomy bag design that can solve the problems of customizable adhesion, good biocompatibility, and diagnostic and therapeutic functions, so as to further improve the patient's postoperative recovery effect. Summary of the invention

[0005] In response to the problems in practical applications, this patent proposes a diagnosis and treatment integrated ostomy bag with customizable adhesion and a preparation method thereof. The main technical improvement is on the adhesive layer of the ostomy bag, which can solve the following three technical problems: 1. The adhesion strength can be customized according to the patient's skin condition and is suitable for wet environments. By designing the digital microstructure of the surface in contact with the human body in the adhesion layer of the ostomy bag, ostomy bags with different adhesion strength values ​​can be customized. The digital microstructure of the adhesion layer can be realized by 3D printing or light curing.

[0006] 2. Integrated diagnosis and treatment design.

[0007] In terms of temperature monitoring, temperature is highly correlated with inflammation, infection, blood supply, etc. of the skin wound around the stoma, and it is beneficial to monitor the temperature during wound healing management. In the design of the material system of the ostomy bag adhesion layer, we introduced temperature-sensitive materials. The temperature-sensitive material is selected to be a material that is sensitive to temperatures above 38 degrees Celsius and causes discoloration, and both ink-like and powdered materials are acceptable. In terms of wound treatment, the material and microstructure design of the adhesion layer can absorb liquids such as tissue fluid and blood, and gradually promote the formation of a microenvironment between the hydrogel and the skin. In addition, the adhesion layer hydrogel forms an effective protective barrier at the wound site to prevent the entry of external pollutants and pathogens. This reduces the risk of infection and provides an optimal environment for cell proliferation and migration. In addition, the adhesion layer hydrogel system proposed in the present invention has significant antibacterial properties, which can inhibit bacterial regeneration, thereby accelerating wound healing.

[0008] 3 The material of the adhesive layer has good biocompatibility and antibacterial properties. The material system design of the adhesive layer adopts a hydrogel double network structure and is mixed with a temperature-sensitive color-changing material, and does not introduce additional hardware sensors, so it has good biocompatibility. The material formula design of the adhesive layer alone provides adhesion customization and diagnostic and treatment functions, and will not cause foreign body sensation or discomfort to patients.

[0009] In summary, the new integrated diagnosis and treatment ostomy bag with customizable adhesion described in this design has significant advantages, including being suitable for wet environments and being able to customize the adhesion size according to the patient's skin condition through micro-nanostructure design, being able to achieve temperature monitoring and skin wound healing functions, and having good biocompatibility and antibacterial properties.

[0010] The object of the present invention is achieved in that: A diagnosis and treatment integrated ostomy bag with customizable adhesion and a preparation method thereof, characterized in that the ostomy bag comprises an ostomy bag body, an adhesive layer and a bag bottom plate, the upper and middle part of the ostomy bag body is in an elliptical spherical shape, the lower part of the ostomy bag body is in a cylindrical shape, the bag bottom plate is arranged in the upper and middle part of the ostomy bag body, the bag bottom plate is composed of two circular rings of different sizes and a connecting shaft, the small circular ring is arranged inside the ostomy bag body, the large circular ring is arranged outside the ostomy bag body through the connecting shaft, the adhesive layer is in an elliptical shape, and the adhesive layer is horizontally arranged on the disk surface of the large disk, and medical staff rotate the adhesive layer by rotating the bag bottom plate, so that the adhesive layer can better absorb harmful substances; Furthermore, the adhesive layer can control its adhesion through digital microstructure, so as to customize the adhesion and suitability for wet environments according to the patient's skin condition; Furthermore, the adhesive layer is made of a material with good biocompatibility and antibacterial properties, and is doped with a thermochromic material, and the thermochromic material has the characteristic that the color changes with temperature, thus realizing the temperature monitoring function. Combined with the temperature change feedback, it can effectively monitor the wound situation and support wound healing management; Furthermore, the adhesive layer contains a hydrogel material, which can make the adhesive layer have the functions of liquid absorption, antibacterial and protective barrier, and can well optimize the post-wound healing environment and accelerate the function of wound healing; Furthermore, a bottom valve having a sealing effect is provided at the lower end of the ostomy bag body.

[0011] The preparation method of the diagnosis and treatment integrated ostomy bag with customizable adhesion of the present invention is: 1. Production of ostomy bag body and bag bottom plate 1. Bag production ① Material selection: The bag body is usually made of soft, durable, and impermeable plastic materials such as polyethylene or polyvinyl chloride. The material should be leak-proof, anti-bacterial and comfortable.

[0012] ②Cutting and forming: Cut the selected plastic film into the required size and shape. Through heat sealing technology, multiple layers of materials are bonded together to form the shape of the bag, such as round, rectangular, etc.

[0013] ③Heat-sealed edge: The edge of the bag is sealed by heat-sealing process to ensure that the bag is sealed and not easy to break.

[0014] ④Reinforced bottom: In some designs, an additional reinforcement layer or bottom valve can be added to the bottom of the bag to facilitate waste discharge.

[0015] 2. Production of bag bottom plate ① Chassis material: The chassis is usually made of soft but durable plastic materials such as polyethylene PE or polyvinyl chloride PVC. These materials have good adhesion and anti-permeability, which can ensure good contact with the skin and prevent leakage.

[0016] ② Chassis molding: First, mold molding, using a special mold to press or injection mold the basic shape of the chassis. Common chassis shapes are round, oval or other customized shapes. This process ensures that the size and shape of the chassis meet the requirements of use, and the surface is smooth to facilitate adhesion in subsequent processes. Secondly, surface treatment, after the chassis is formed, surface treatment may be performed, such as heating, polishing, etc., to ensure the smoothness and surface cleanliness of the adhesion area and increase the adhesion of the adhesive.

[0017] 3. Connection between the bag bottom plate and the ostomy bag body ① Heat sealing or bonding: The connection between the chassis and the bag body needs to be heat sealed or bonded with adhesives to form a stable connection between the bag bottom and the bag body. The heat sealing process can heat the plastic parts at high temperatures to melt and bond them, ensuring the sealing of the connection parts.

[0018] ②Sealing test: After the connection is completed, perform a sealing test to ensure that there is no leakage or penetration at the joint between the chassis and the bag body.

[0019] 2. Preparation of the main hydrogel pre-curing solution material of the adhesion layer The main material is composed of polyacrylamide PAAm, polyethylene glycol diacrylate PEGDA and MXene materials. This material formula provides good mechanical and electrical properties. Specifically, 35g acrylamide (AM, aladdin, acrylamide), 1mg polyethylene glycol diacrylate (PEGDA), 50mg phenyl 2,4,6-trimethylbenzoyl phosphate lithium photoinitiator LAP, Engineering For Life, 5mg photoresist (UVAM-001) and temperature-sensitive ink are mixed and dissolved in 100ml of deionized water DI, and the mixture is stirred overnight until a clear solution is obtained. Then use an ultrasonic cleaner to vibrate for five minutes.

[0020] 3. Mold production with micro-nano structures 1. Digital design and modeling of microstructures First, it is necessary to design a 3D model with a micro-nano scale structure array. The structure can be selected according to different adhesion requirements. For example, columnar structure, suction cup structure, plane structure, etc. Different types of micro-nano structures are selected according to the design requirements of the ostomy bag. There are mainly the following common types: ① Columnar structure: Suitable for areas that require stronger adhesion. The columnar structure can provide a larger contact area and good fixing force.

[0021] ②Suction cup structure: Suitable for scenes that require high adhesion and stability. The suction cup structure can increase adhesion through the vacuum effect.

[0022] ③ Planar structure: Suitable for applications with lower adhesion requirements. The design of the planar structure is simpler and convenient for mass production.

[0023] Use computer-aided design (CAD) software to perform 3D modeling of micro-nano structures. The following points should be considered during design: ①Structural size and proportion: The size of the micro-nano structure is set according to the actual application requirements to ensure that it can meet the adhesion requirements of different skin types. In the experimental data, the diameter of the microstructure is 1.2mm, and the spacing between the microstructure arrays is 200um.

[0024] ② Array arrangement: Select an appropriate arrangement such as grid, symmetrical arrangement, random arrangement, etc. to ensure that the micro-nano structure is evenly distributed during the application process and provide stable adhesion.

[0025] ③ Spacing and density: The spacing and density between micro-nano structures should be adjusted according to the required adhesion. Generally speaking, the smaller the spacing, the stronger the adhesion, but it is also necessary to avoid excessive contact pressure.

[0026] After completing the model in the CAD software, use 3D modeling software such as AutoCAD, SolidWorks, etc. to export the STL file format suitable for 3D printing.

[0027] 2. Mold printing stage After the design is completed and the 3D model is exported, the mold printing stage begins, and 3D printing technology is used to realize the production of micro-nano structure molds.

[0028] The production method uses stereolithography SLA, and the printing material selects photosensitive resin to achieve fine printing of micro-nano structures.

[0029] 3D Printing Process: ① Prepare the printer: According to the selected 3D printing technology, set the printer parameters such as resolution, layer thickness, printing speed, etc.

[0030] ②Printing process: Import the digital design file STL file into the 3D printer and start printing the mold. The printing process is usually divided into multiple layers and stacked step by step. Ensure that the material is evenly deposited during the printing process to avoid structural defects or distortion.

[0031] ③ Post-processing: After printing is completed, post-processing is required, such as removing support structures, curing photosensitive resins, and surface treatment to ensure the accuracy and smoothness of the mold.

[0032] 4. Preparation of the adhesive layer of the ostomy bag The adhesive layer of the ostomy bag is prepared by pouring the pre-cured solution prepared in the first step into the mold containing the micro-nano structure prepared in the second step and then photocuring it. The adhesive layer of the ostomy bag with micro-nano structure can be prepared by curing the area by ultraviolet light for half an hour. This method not only accurately controls the morphology and size of the micro-nano structure, but also provides customized adhesion, ensuring that the adhesive layer can meet the skin requirements and usage environment of different patients. The specific steps are as follows: 1. Prepare the Micro-nanostructure Mold According to the design and printing process in the second step, a mold with the desired micro-nano structure array is prepared. The mold is usually made of photosensitive resin or other materials suitable for micro-nano structure replication through 3D printing or other methods. The mold surface should be clean, free of dust and impurities to ensure the accuracy of the micro-nano structure.

[0033] The size and shape of the mold should be made according to the design requirements of the final ostomy bag, especially the arrangement, size and density of the micro-nano structure. Ensure that the micro-nano structure in the mold can be accurately transferred to the adhesive layer to produce the required adhesion characteristics.

[0034] 2. Pour in the pre-curing solution Pour the prepared pre-curing solution into the prepared mold containing the micro-nano structure, and the liquid level of the solution is 2mm. At this time, it is necessary to ensure that the liquid evenly fills each microstructure array of the mold to avoid bubbles or unevenness. In order to avoid the generation of air bubbles, you can take methods such as gentle vibration or vacuuming to ensure that the liquid fully penetrates into each micro-nano structure. At this time, the photosensitive resin is in an uncured state and can contact well with the micro-nano structure of the mold to form a preliminary structure.

[0035] 3. UV light curing The pre-curing solution poured into the mold is cured by ultraviolet light. Ultraviolet light irradiation will excite the photoinitiator, causing the resin to undergo photopolymerization reaction, thereby curing in a short time to form an adhesion layer. UV light source setting: Select a suitable UV light source such as a UV lamp or LED UV lamp, and adjust the intensity and irradiation time of the UV light. Usually, the irradiation time is 30 minutes, and the light intensity should be moderate to ensure that the resin can be cured evenly, while avoiding damage to the mold due to excessive exposure.

[0036] 4.Complete curing and mold taking After 30 minutes of UV irradiation, the pre-curing solution has completed the curing process, and the shape and micro-nanostructure characteristics of the adhesion layer have stabilized. At this point, the mold can be removed and the following treatments can be performed: ① Remove excess material: If there is excess solution in the mold, use a scraper or other tools to remove excess resin to ensure that the adhesive layer surface of the ostomy bag is smooth.

[0037] ② Demolding: Carefully remove the cured adhesive layer from the mold, and avoid damaging the micro-nano structure of the adhesive layer during the process. Usually, gently pry or use appropriate tools to help demold to ensure the integrity of the structure.

[0038] ③ Post-curing: Sometimes, in order to enhance the strength and durability of the adhesive layer, the adhesive layer can be further cured under ultraviolet light after being removed to ensure the thoroughness of the photopolymerization reaction.

[0039] 5. Fixing the adhesive layer to the bag bottom plate In this step, the prepared adhesive layer with micro-nano structure is firmly bonded to the bottom plate of the bag opening of the ostomy bag, which is usually a base or substrate. In order to ensure a long-term and stable bond between the two, a high-strength adhesive is used as a fixing medium. This process must ensure a strong mechanical adhesion to ensure the reliability and safety of the final product in long-term use.

[0040] 1. Adhesive selection Choosing a high-performance strong glue suitable for the medical field is the key to ensure a firm bond between the two. The following types of adhesives are recommended: Medical-grade acrylic adhesive: This type of adhesive has excellent adhesion, durability and biocompatibility. Acrylic adhesive forms a strong adhesive layer after curing, which can effectively fix the adhesive layer to the bag bottom plate together to adapt to changes in the skin and environment. Epoxy resin adhesive: Epoxy resin adhesive can provide strong structural strength during the curing process and is suitable for occasions that need to withstand external forces for a long time. Due to its high mechanical strength and stability, it is particularly suitable for environments with high requirements for water resistance and heat resistance.

[0041] 2. Fixation process ① Surface cleaning and treatment: Before bonding the adhesive layer and the bag bottom plate, the contact surface of the two needs to be thoroughly cleaned and treated. Cleaning work includes removing surface oil, dust and impurities that may affect the bonding effect. Solvents such as isopropyl alcohol are often used for cleaning to ensure that there are no contaminants on the surface.

[0042] ② Adhesive coating: According to the type of adhesive, use appropriate coating methods to evenly coat the adhesive on the contact surface of the bag bottom plate. For adhesives with strong fluidity, you can use a scraper, brush or roller coating; for thicker adhesives, you can apply them by dispensing or spraying. During the coating process, ensure that the adhesive is evenly distributed to avoid bubbles or uneven bonding areas.

[0043] ③Fix and pressurize: Align the bottom plate of the bag with the adhesive and the adhesive layer, and gently press the two together. You can use a press, press manually or add weights to pressurize to ensure that the two surfaces can maintain good contact during the curing process of the adhesive, thereby ensuring the stability of the joint. The time and pressure of pressurization should be adjusted according to the curing requirements of the selected adhesive.

[0044] ④ Curing process: The curing process of adhesives may be chemical reaction type such as epoxy resin glue or physical reaction type such as silicone. For epoxy resin glue, it usually needs to be cured for a certain period of time at room temperature, or accelerated curing under heating conditions; for acrylic glue or silicone, ultraviolet irradiation or natural air curing may be required. Make sure that the adhesive is completely cured before proceeding with subsequent operations.

[0045] 3. Post-fixation processing and inspection Cross-section inspection: After fixing is completed, take a sample to check the cross-section of the joint to ensure that the adhesive is evenly applied and there are no bubbles or defects. The joint surface can be carefully analyzed by microscope or scanning electron microscope SEM to ensure that there is no delamination between the adhesive layer and the substrate.

[0046] Durability test: Durability test is carried out for a certain period of time by simulating the actual wearing environment. These tests may include adhesion evaluation under temperature and humidity changes, tensile test, shear force test, etc., to ensure that in actual application, the bonding between the adhesive layer and the bag bottom plate does not loosen or fail.

[0047] Through the above steps, the adhesive layer is fixed to the bottom plate of the bag mouth with a high-performance adhesive, which not only ensures the stability of the product, but also ensures the use effect of the ostomy bag under the premise of ensuring biocompatibility and environmental adaptability. Appropriate adhesive selection and optimized fixing process ensure the long-term stable combination between the adhesive layer and the bottom plate of the ostomy bag, thereby improving the reliability of the product and the comfort of patients when using it.

[0048] Compared with the prior art, the present invention has the following beneficial effects: 1. This diagnosis and treatment ostomy bag can accurately adjust the adhesion according to the patient's skin condition, which not only ensures the stability of the ostomy bag, but also avoids excessive adhesion causing damage or discomfort to the skin. Especially in wet environments, it can maintain good adhesion and avoid falling off or looseness caused by liquid penetration, thereby improving the reliability of the product in practical applications and the feasibility of long-term wear.

[0049] 2. This diagnosis and treatment integrated ostomy bag not only has the traditional adhesion function by introducing temperature-sensitive color-changing materials, but also can monitor temperature changes in real time, provide real-time feedback for wound management, and increase the versatility of the ostomy bag. In terms of wound treatment, the hydrogel in the adhesion layer can not only absorb tissue fluid and blood, but also form an effective protective barrier to prevent external pollutants from entering the wound and reduce the risk of infection. At the same time, the hydrogel system has significant antibacterial properties, which helps to inhibit bacterial growth, accelerate wound healing, and improve treatment effects.

[0050] 3. This integrated diagnosis and treatment ostomy bag avoids the use of additional hardware sensors commonly found in traditional diagnosis and treatment equipment, reduces irritation to the patient's skin, and also makes the ostomy bag lighter and easier to wear. The biocompatibility of the material ensures that it will not cause allergic reactions or other adverse reactions when in contact with the skin for a long time, thereby improving the safety of the product and patient acceptance. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Figure 1 This is a structural diagram of the integrated diagnosis and treatment ostomy bag.

[0052] Figure 2 Customize different adhesion force diagrams for different noble structure arrays.

[0053] Figure 3 Schematic diagram of the shear strength of different microstructure arrays.

[0054] Figure 4 Schematic diagram of the biocompatibility test of the adhesion layer material and the hydrogel adhesion layer.

[0055] Figure 5 Schematic diagram of antibacterial test for adhesion layer materials.

[0056] Figure 6 Flow chart for the preparation of a diagnostic and therapeutic ostomy bag with customizable adhesion.

[0057] Among them, 1 is the body of the ostomy bag, 2 is the adhesive layer, 3 is the bottom plate of the bag opening, and 4 is the bottom valve. DETAILED DESCRIPTION

[0058] like Figure 1-6 As shown, an integrated diagnosis and treatment ostomy bag with customizable adhesion is characterized in that it includes an ostomy bag body 1, an adhesive layer 2 and a bag bottom plate 3, the upper and middle part of the ostomy bag body 1 is ellipsoidal, the lower part of the ostomy bag body 1 is cylindrical, the bag bottom plate 3 is arranged in the upper and middle part of the ostomy bag body 1, the bag bottom plate 3 is composed of two circular rings of different sizes and a connecting shaft, the small circular ring is arranged inside the ostomy bag body 1, and the large circular ring is arranged outside the ostomy bag body 1 through the connecting shaft, the adhesive layer 2 is elliptical, and the adhesive layer 2 is horizontally arranged on the disk surface of the large disk, and medical staff rotates the adhesive layer 2 by rotating the bag bottom plate 3, so that the adhesive layer 2 can better absorb harmful substances.

[0059] Furthermore, the adhesive layer 2 can control its adhesive force through a digital microstructure, so as to customize the adhesive force and suitability for wet environments according to the patient's skin condition.

[0060] Furthermore, the adhesive layer 2 is made of a material with good biocompatibility and antibacterial properties, and is doped with a thermochromic material inside. The thermochromic material has the characteristic that the color changes with temperature, thereby realizing the temperature monitoring function. Combined with the temperature change feedback, it can effectively monitor the wound situation and support wound healing management.

[0061] Furthermore, the adhesive layer 2 contains hydrogel material, which can enable the adhesive layer 2 to have the functions of liquid absorption, antibacterial and protective barrier, and can well optimize the post-wound healing environment and accelerate the function of wound healing.

[0062] Furthermore, a bottom valve 4 for sealing is provided at the lower end of the ostomy bag body 1 .

[0063] Furthermore, a method for preparing a diagnosis and treatment integrated ostomy bag with customizable adhesion is as follows: 1. Production of ostomy bag body 1 and bag bottom plate 3 2. Bag making ① Material selection: The bag body is usually made of soft, durable, and impermeable plastic materials such as polyethylene or polyvinyl chloride. The material should be leak-proof, anti-bacterial and comfortable.

[0064] ②Cutting and forming: Cut the selected plastic film into the required size and shape. Through heat sealing technology, multiple layers of materials are bonded together to form the shape of the bag, such as round, rectangular, etc.

[0065] ③Heat-sealed edge: The edge of the bag is sealed by heat-sealing process to ensure that the bag is sealed and not easy to break.

[0066] ④ Reinforced bottom: In some designs, an additional reinforcement layer or bottom valve 4 can be added to the bottom of the bag to facilitate waste discharge.

[0067] 2. Production of bag bottom plate 3 ① Chassis material: The chassis is usually made of soft but durable plastic materials such as polyethylene PE or polyvinyl chloride PVC. These materials have good adhesion and anti-permeability, which can ensure good contact with the skin and prevent leakage.

[0068] ② Chassis molding: First, mold molding, using a special mold to press or injection mold the basic shape of the chassis. Common chassis shapes are round, oval or other customized shapes. This process ensures that the size and shape of the chassis meet the requirements of use, and the surface is smooth to facilitate adhesion in subsequent processes. Secondly, surface treatment, after the chassis is formed, surface treatment may be performed, such as heating, polishing, etc., to ensure the smoothness and surface cleanliness of the adhesion area and increase the adhesion of the adhesive.

[0069] 3. Connection between the bag bottom plate 3 and the ostomy bag body 1 ① Heat sealing or bonding: The connection between the chassis and the bag body needs to be bonded by heat sealing or adhesive, so that the bag bottom plate 3 and the bag body form a stable connection. The heat sealing process can heat the plastic parts at high temperature to melt and bond them, ensuring the sealing of the connection parts.

[0070] ②Sealing test: After the connection is completed, perform a sealing test to ensure that there is no leakage or penetration at the joint between the chassis and the bag body.

[0071] 2. Preparation of the main hydrogel pre-curing solution material of the adhesion layer 2 The main material is composed of polyacrylamide PAAm, polyethylene glycol diacrylate PEGDA and MXene materials. This material formula provides good mechanical and electrical properties. Specifically, 35g acrylamide (AM, aladdin, acrylamide), 1mg polyethylene glycol diacrylate (PEGDA), 50mg phenyl 2,4,6-trimethylbenzoyl phosphate lithium photoinitiator LAP, Engineering For Life, 5mg photoresist (UVAM-001) and temperature-sensitive ink are mixed and dissolved in 100ml of deionized water DI, and the mixture is stirred overnight until a clear solution is obtained. Then use an ultrasonic cleaner to vibrate for five minutes.

[0072] 3. Mold production with micro-nano structures 1. Digital design and modeling of microstructures First, it is necessary to design a 3D model with a micro-nano scale structure array. The structure can be selected according to different adhesion requirements. For example, columnar structure, suction cup structure, plane structure, etc. Different types of micro-nano structures are selected according to the design requirements of the ostomy bag. There are mainly the following common types: ① Columnar structure: Suitable for areas that require stronger adhesion. The columnar structure can provide a larger contact area and good fixing force.

[0073] ②Suction cup structure: Suitable for scenes that require high adhesion and stability. The suction cup structure can increase adhesion through the vacuum effect.

[0074] ③ Planar structure: Suitable for applications with lower adhesion requirements. The design of the planar structure is simpler and convenient for mass production.

[0075] Use computer-aided design (CAD) software to perform 3D modeling of micro-nano structures. The following points should be considered during design: ①Structural size and proportion: The size of the micro-nano structure is set according to the actual application requirements to ensure that it can meet the adhesion requirements of different skin types. In the experimental data, the diameter of the microstructure is 1.2mm, and the spacing between the microstructure arrays is 200um.

[0076] ② Array arrangement: Select an appropriate arrangement such as grid, symmetrical arrangement, random arrangement, etc. to ensure that the micro-nano structure is evenly distributed during the application process and provide stable adhesion.

[0077] ③ Spacing and density: The spacing and density between micro-nano structures should be adjusted according to the required adhesion. Generally speaking, the smaller the spacing, the stronger the adhesion, but it is also necessary to avoid excessive contact pressure.

[0078] After completing the model in the CAD software, use 3D modeling software such as AutoCAD, SolidWorks, etc. to export the STL file format suitable for 3D printing.

[0079] 2. Mold printing stage After the design is completed and the 3D model is exported, the mold printing stage begins, and 3D printing technology is used to realize the production of micro-nano structure molds.

[0080] The production method uses stereolithography SLA, and the printing material selects photosensitive resin to achieve fine printing of micro-nano structures.

[0081] 3D Printing Process: ① Prepare the printer: According to the selected 3D printing technology, set the printer parameters such as resolution, layer thickness, printing speed, etc.

[0082] ②Printing process: Import the digital design file STL file into the 3D printer and start printing the mold. The printing process is usually divided into multiple layers and stacked step by step. Ensure that the material is evenly deposited during the printing process to avoid structural defects or distortion.

[0083] ③ Post-processing: After printing is completed, post-processing is required, such as removing support structures, curing photosensitive resins, and surface treatment to ensure the accuracy and smoothness of the mold.

[0084] 4. Preparation of Ostomy Bag Adhesive Layer 2 The adhesive layer 2 of the ostomy bag is prepared by pouring the pre-cured solution prepared in the first step into the mold containing the micro-nano structure prepared in the second step and then photocuring it. The adhesive layer 2 of the ostomy bag with the micro-nano structure can be prepared by generating a regional photoreaction and curing for half an hour by ultraviolet irradiation. This method not only accurately controls the morphology and size of the micro-nano structure, but also provides customized adhesion, ensuring that the adhesive layer 2 can meet the skin requirements and usage environment of different patients. The specific steps are as follows: 1. Prepare the Micro-nanostructure Mold According to the design and printing process in the second step, a mold with the desired micro-nano structure array is prepared. The mold is usually made of photosensitive resin or other materials suitable for micro-nano structure replication through 3D printing or other methods. The mold surface should be clean, free of dust and impurities to ensure the accuracy of the micro-nano structure.

[0085] The size and shape of the mold should be made according to the design requirements of the final ostomy bag, especially the arrangement, size and density of the micro-nano structure, to ensure that the micro-nano structure in the mold can be accurately transferred to the adhesive layer 2 to produce the required adhesion characteristics.

[0086] 2. Pour in the pre-curing solution Pour the prepared pre-curing solution into the prepared mold containing the micro-nano structure, and the liquid level of the solution is 2mm. At this time, it is necessary to ensure that the liquid evenly fills each microstructure array of the mold to avoid bubbles or unevenness. In order to avoid the generation of air bubbles, you can take methods such as gentle vibration or vacuuming to ensure that the liquid fully penetrates into each micro-nano structure. At this time, the photosensitive resin is in an uncured state and can contact well with the micro-nano structure of the mold to form a preliminary structure.

[0087] 3. UV light curing The pre-curing solution poured into the mold is cured by ultraviolet light. Ultraviolet light irradiation will excite the photoinitiator, causing the resin to undergo photopolymerization reaction, thereby curing in a short time to form an adhesion layer 2. UV light source setting: Select a suitable UV light source such as a UV lamp or LED UV lamp, and adjust the intensity and irradiation time of the UV light. Usually, the irradiation time is 30 minutes, and the light intensity should be moderate to ensure that the resin can be evenly cured, while avoiding damage to the mold caused by excessive exposure.

[0088] 4.Complete curing and mold taking After 30 minutes of UV irradiation, the pre-curing solution has completed the curing process, and the shape and micro-nanostructure characteristics of the adhesion layer 2 have stabilized. At this time, the mold can be removed and the following treatments can be performed: ① Remove excess material: If there is excess solution in the mold, use a scraper or other tools to remove excess resin to ensure that the surface of the adhesive layer 2 of the ostomy bag is flat.

[0089] ② Demolding: Carefully remove the cured adhesive layer 2 from the mold, and avoid damaging the micro-nano structure of the adhesive layer 2 during the process. Usually, gently pry or use appropriate tools to help demolding to ensure the integrity of the structure.

[0090] ③ Post-curing: Sometimes, in order to enhance the strength and durability of the adhesive layer 2, the adhesive layer 2 may be further cured under ultraviolet light after being removed to ensure the thoroughness of the photopolymerization reaction.

[0091] 5. Fixing of Adhesive Layer 2 and Bag Bottom Plate 3 In this step, the prepared adhesive layer 2 with micro-nano structure is firmly bonded to the bag bottom plate 3 of the ostomy bag, which is usually a base or substrate. In order to ensure a long-term stable bond between the two, a high-strength adhesive is used as a fixing medium. This process must ensure a strong mechanical adhesion to ensure the reliability and safety of the final product in long-term use.

[0092] 1. Adhesive selection Selecting high-performance strong glue suitable for the medical field is the key to ensure a firm bond between the two. The following types of adhesives are recommended: Medical grade acrylic adhesive: This type of adhesive has excellent adhesion, durability and biocompatibility. Acrylic adhesive forms a strong adhesive layer after curing, which can effectively fix the adhesive layer 2 and the bag bottom plate 3 together to adapt to changes in the skin and environment. Epoxy resin adhesive: Epoxy resin adhesive can provide strong structural strength during the curing process and is suitable for occasions that need to withstand external forces for a long time. Due to its high mechanical strength and stability, it is particularly suitable for environments with high requirements for water resistance and heat resistance.

[0093] 2. Fixation process ① Surface cleaning and treatment: Before bonding the adhesive layer 2 and the bag bottom plate 3, the contact surfaces of the two need to be thoroughly cleaned and treated. Cleaning work includes removing surface oil, dust and impurities that may affect the bonding effect. Solvents such as isopropyl alcohol are often used for cleaning to ensure that there are no contaminants on the surface.

[0094] ② Adhesive coating: According to the type of adhesive, use appropriate coating methods to evenly coat the adhesive on the contact surface of the bag bottom plate 3. For adhesives with strong fluidity, a scraper, brush or roller coating can be used; for thicker adhesives, dispensing or spraying can be used for coating. During the coating process, ensure that the adhesive is evenly distributed to avoid bubbles or uneven bonding areas.

[0095] ③Fix and pressurize: Align the bag bottom plate 3 coated with adhesive with the adhesive layer 2, and gently press the two together. Pressurization can be performed using a press, manual pressing, or weights to ensure that the two surfaces can maintain good contact during the curing process of the adhesive, thereby ensuring the stability of the joint. The time and pressure of pressurization should be adjusted according to the curing requirements of the selected adhesive.

[0096] ④ Curing process: The curing process of adhesives may be chemical reaction type such as epoxy resin glue or physical reaction type such as silicone. For epoxy resin glue, it usually needs to be cured for a certain period of time at room temperature, or accelerated curing under heating conditions; for acrylic glue or silicone, ultraviolet irradiation or natural air curing may be required. Make sure that the adhesive is completely cured before proceeding with subsequent operations.

[0097] 3. Post-fixation processing and inspection Cross-section inspection: After fixing is completed, take a sample to check the cross-section of the joint to ensure that the adhesive is evenly applied and there are no bubbles or defects. The joint surface can be carefully analyzed by microscope or scanning electron microscope SEM to ensure that there is no delamination between the adhesive layer and the substrate.

[0098] Durability test: Durability test is performed for a certain period of time by simulating the actual wearing environment. These tests may include adhesion evaluation under temperature and humidity changes, tensile test, shear force test, etc., to ensure that in actual application, the combination of the adhesive layer 2 and the bag bottom plate 3 does not loosen or fail.

[0099] Through the above steps, the adhesive layer (2) and the bag bottom plate (3) are fixed together using a high-performance adhesive, which not only ensures the stability of the product, but also ensures the use effect of the ostomy bag under the premise of ensuring biocompatibility and environmental adaptability. Appropriate adhesive selection and optimized fixing process ensure long-term stable bonding between the adhesive layer (2) and the bottom plate of the ostomy bag, thereby improving the reliability of the product and the comfort of patients when using it.

[0100] The present invention is not limited to the above-mentioned embodiments. On the basis of the technical solution disclosed in the present invention, technicians in this field can make some substitutions and deformations to some technical features therein according to the disclosed technical content without creative labor, and these substitutions and deformations are all within the protection scope of the present invention.

Claims

1. A diagnosis and treatment integrated ostomy bag with customizable adhesion, characterized in that: The invention comprises an ostomy bag body (1), an adhesive layer (2) and a bag bottom plate (3); the upper middle portion of the ostomy bag body (1) is ellipsoidal, the lower portion of the ostomy bag body (1) is cylindrical, the bag bottom plate (3) is arranged at the upper middle portion of the ostomy bag body (1), the bag bottom plate (3) is composed of two circular rings of different sizes and a connecting shaft, the small circular ring is arranged inside the ostomy bag body (1), and the large circular ring is arranged outside the ostomy bag body (1) via the connecting shaft, the adhesive layer (2) is ellipsoidal, and the adhesive layer (2) is arranged horizontally on the disk surface of the large circular disk, and medical staff rotate the adhesive layer (2) by rotating the bag bottom plate (3), so that the adhesive layer (2) can better absorb harmful substances.

2. The diagnosis and treatment integrated ostomy bag with customizable adhesion according to claim 1, characterized in that: The adhesive layer (2) can control its adhesive force through a digital microstructure, thereby customizing the adhesive force and suitability for wet environments according to the patient's skin condition.

3. The integrated diagnosis and treatment ostomy bag with customizable adhesion according to claim 1, characterized in that: The adhesive layer (2) is made of a material with good biocompatibility and antibacterial properties, and is doped with a temperature-sensitive color-changing material. The temperature-sensitive color-changing material has the characteristic that its color changes with temperature, thus realizing a temperature monitoring function. Combined with temperature change feedback, it can effectively monitor the wound condition and support wound healing management.

4. The diagnosis and treatment integrated ostomy bag with customizable adhesion according to claim 1, characterized in that: The adhesive layer (2) contains a hydrogel material inside. The hydrogel material can enable the adhesive layer (2) to have the functions of liquid absorption, antibacterial and protective barrier, and can well optimize the post-wound healing environment and accelerate the function of wound healing.

5. The diagnosis and treatment integrated ostomy bag with customizable adhesion according to claim 1, characterized in that: The lower end of the ostomy bag body (1) is provided with a bottom valve (4) which performs a sealing function.

6. The method for preparing a diagnosis and treatment integrated ostomy bag with customizable adhesion according to claim 1 is:

1. Production of the ostomy bag body (1) and the bag bottom plate (3) 1. Bag production ① Material selection: The bag body is usually made of soft, durable, and impermeable plastic material (such as polyethylene or polyvinyl chloride); the material should be leak-proof, anti-bacterial and comfortable; ②Cutting and forming: Cut the selected plastic film into the required size and shape. Through heat sealing technology, multiple layers of materials are bonded together to form the shape of the bag (such as round, rectangular, etc.); ③Heat-sealing edge: The edge of the bag is sealed by heat-sealing process to ensure that the bag is sealed and not easy to break; ④ Reinforced bottom: In some designs, an additional reinforcement layer or bottom valve (4) can be added to the bottom of the bag to facilitate waste discharge; 2. Fabrication of the bag bottom plate (3) ① Chassis material: The chassis is usually made of soft but durable plastic materials such as polyethylene (PE) or polyvinyl chloride (PVC). These materials have good adhesion and anti-permeability, which can ensure good contact with the skin and prevent leakage; ② Chassis molding: First, mold molding, using a special mold to press or injection mold the basic shape of the chassis. Common chassis shapes are round, oval or other customized shapes. This process ensures that the size and shape of the chassis meet the requirements of use, and the surface is smooth to facilitate adhesion in subsequent processes. Secondly, surface treatment, after the chassis is formed, surface treatment may be performed, such as heating, polishing, etc., to ensure the smoothness and surface cleanliness of the adhesion area and increase the adhesion of the adhesive; 3. Connection between the bag bottom plate (3) and the ostomy bag body (1) ① Heat sealing or bonding: The connection between the bottom plate and the bag body needs to be heat sealed or bonded with adhesives, so that the bottom plate (3) at the bag mouth and the bag body form a stable connection. The heat sealing process can heat the plastic parts at high temperatures to melt and bond them, thereby ensuring the sealing of the connection parts; ②Sealing test: After the connection is completed, perform a sealing test to ensure that there is no leakage or penetration at the joint between the chassis and the bag body; 2. Preparation of the main hydrogel pre-curing solution material of the adhesion layer (2) The main material is composed of polyacrylamide (PAAm), polyethylene glycol diacrylate (PEGDA) and MXene materials. This material formula provides good mechanical and electrical properties. Specifically, 35g acrylamide (AM, aladdin, acrylamide), 1mg polyethylene glycol (diol) diacrylate (PEGDA), 50mg phenyl (2,4,6-trimethylbenzoyl) lithium phosphate (photoinitiator LAP, Engineering For Life), 5mg photoresist (UVAM-001) and temperature-sensitive ink are mixed and dissolved in 100ml of deionized water (DI), and the mixture is stirred overnight until a clear solution is obtained. Then use an ultrasonic cleaner to vibrate for five minutes; 3. Mold production with micro-nano structures 1. Digital design and modeling of microstructures First, it is necessary to design a 3D graphic model with a micro-nano scale structure array. The structural form can select a suitable micro-nano structure form according to different adhesion requirements, such as columnar structure, suction cup structure, planar structure, etc. Different types of micro-nano structures are selected according to the design requirements of the ostomy bag. There are mainly the following common types: ① Columnar structure: suitable for areas that require strong adhesion, the columnar structure can provide a larger contact area and good fixing force; ②Suction cup structure: suitable for scenes that require high adhesion and stability. The suction cup structure can increase adhesion through the vacuum effect; ③ Planar structure: suitable for applications with lower adhesion requirements. The design of the planar structure is simpler and convenient for mass production; Use computer-aided design (CAD) software to perform 3D modeling of micro-nano structures; the following points should be considered during design: ①Structural size and proportion: The size of the micro-nanostructure is set according to the actual application requirements to ensure that it can meet the adhesion requirements of different skin types; the diameter of the microstructure in the experimental data is 1.2mm, and the spacing between the microstructure arrays is 200um; ② Array arrangement: Select an appropriate arrangement (such as grid, symmetrical arrangement, random arrangement, etc.) to ensure that the micro-nano structures are evenly distributed during the application process and provide stable adhesion; ③ Spacing and density: The spacing and density between micro-nano structures should be adjusted according to the required adhesion; generally speaking, the smaller the spacing, the stronger the adhesion, but it is also necessary to avoid excessive contact pressure; After completing the model in the CAD software, use 3D modeling software (such as AutoCAD, SolidWorks, etc.) to export the STL file format suitable for 3D printing; 2. Mold printing stage After the design is completed and the 3D model is exported, the mold printing stage begins, using 3D printing technology to realize the production of micro-nano structure molds; The production method uses stereolithography (SLA), and the printing material is photosensitive resin, which can print micro-nano structures in detail; 3D Printing Process: ①Prepare the printer: Set the printer parameters (such as resolution, layer thickness, printing speed, etc.) according to the selected 3D printing technology; ②Printing process: Import the digital design file (STL file) into the 3D printer and start printing the mold; the printing process is usually divided into multiple layers and stacked step by step; Ensure that during the printing process, the material is deposited evenly to avoid structural defects or distortion; ③ Post-processing: After printing, post-processing is required, such as removing support structures, curing (for photosensitive resins) and surface treatment to ensure the accuracy and smoothness of the mold; 4. Preparation of the Ostomy Bag Adhesive Layer (2) The adhesive layer (2) of the ostomy bag is prepared by pouring the pre-cured solution prepared in the first step into the mold containing the micro-nano structure prepared in the second step and then photocuring it. The adhesive layer (2) of the ostomy bag with the micro-nano structure can be prepared by generating a regional photoreaction and curing it for half an hour by ultraviolet light irradiation. This method not only accurately controls the morphology and size of the micro-nano structure, but also provides customized adhesion, ensuring that the adhesive layer (2) can meet the skin requirements and usage environment of different patients. The specific steps are as follows:

1. Prepare the Micro-nanostructure Mold According to the design and printing process in the second step, a mold with the desired micro-nano structure array is prepared; the mold is usually made of photosensitive resin or other materials suitable for micro-nano structure replication through 3D printing or other methods; the mold surface should be clean, free of dust and impurities to ensure the accuracy of the micro-nano structure; The size and shape of the mold should be made according to the design requirements of the final ostomy bag, especially the arrangement, size and density of the micro-nanostructures; Ensure that the micro-nanostructure in the mold can be accurately transferred to the adhesive layer (2) to produce the desired adhesion characteristics; 2. Pour in the pre-curing solution Pour the prepared pre-curing solution into the prepared mold containing the micro-nano structure, and the liquid level height of the solution is 2mm; At this point, it is necessary to ensure that the liquid evenly fills each microstructure array of the mold to avoid bubbles or unevenness. In order to avoid the generation of air bubbles, gentle vibration or vacuuming can be used to ensure that the liquid fully penetrates into each micro-nano structure. At this point, the photosensitive resin is in an uncured state and can be in good contact with the micro-nano structure of the mold to form a preliminary structure.

3. UV light curing The pre-curing solution poured into the mold is cured by ultraviolet light. The ultraviolet light will excite the photoinitiator, causing the resin to undergo a photopolymerization reaction, thereby curing in a short time to form an adhesion layer (2); UV light source setting: select a suitable ultraviolet light source (such as a UV lamp or an LED UV lamp), and adjust the intensity and exposure time of the ultraviolet light; usually, the exposure time is 30 minutes, and the light intensity should be moderate to ensure that the resin can be evenly cured, while avoiding damage to the mold due to excessive exposure; 4.Complete curing and mold taking After 30 minutes of UV irradiation, the pre-curing solution has completed the curing process, and the shape and micro-nanostructure characteristics of the adhesion layer (2) have stabilized; At this point, the mold can be removed and processed as follows: ① Remove excess material: If there is excess solution in the mold, use a scraper or other tool to remove excess resin to ensure that the surface of the adhesive layer (2) of the ostomy bag is smooth; ② Demolding: Carefully remove the cured adhesive layer (2) from the mold, and avoid damaging the micro-nano structure of the adhesive layer (2) during the process; usually, gently pry or use appropriate tools to help demolding to ensure the integrity of the structure; ③ Post-curing: Sometimes, in order to enhance the strength and durability of the adhesive layer (2), the adhesive layer (2) may be further cured under ultraviolet light after being removed to ensure the thoroughness of the photopolymerization reaction; 5. Fixing the Adhesive Layer (2) and the Bag Bottom Plate (3) In this step, the prepared adhesive layer with micro-nano structure (2) is firmly bonded to the bag opening bottom plate (3) (usually a base or substrate) of the ostomy bag; in order to ensure a long-term stable bond between the two, a high-strength adhesive is used as a fixing medium; this process must ensure a strong mechanical bonding force to ensure the reliability and safety of the final product in long-term use; 1. Adhesive selection Selecting high-performance strong glue suitable for the medical field is the key to ensure a firm bond between the two. The following types of adhesives are recommended: Medical grade acrylic adhesive: This type of adhesive has excellent adhesion, durability and biocompatibility. After curing, acrylic adhesive forms a strong adhesive layer that can effectively fix the adhesive layer (2) and the bag bottom plate (3) together to adapt to changes in the skin and environment. Epoxy resin adhesive: Epoxy resin adhesive can provide strong structural strength during the curing process and is suitable for occasions that need to withstand external forces for a long time. Due to its high mechanical strength and stability, it is particularly suitable for environments with high requirements for water resistance and heat resistance.

2. Fixation process ① Surface cleaning and treatment: Before bonding the adhesive layer (2) and the bag bottom plate (3), the contact surfaces of the two need to be thoroughly cleaned and treated. The cleaning work includes removing surface oil, dust and impurities that may affect the bonding effect. Solvents such as isopropyl alcohol are often used for cleaning to ensure that there are no contaminants on the surface. ② Adhesive coating: according to the type of adhesive, use appropriate coating methods to evenly coat the adhesive on the contact surface of the bag bottom plate (3); for adhesives with strong fluidity, a scraper, brush or roller coating method can be used; for thicker adhesives, dispensing or spraying can be used for coating; during the coating process, ensure that the adhesive is evenly distributed to avoid bubbles or uneven bonding areas; ③ Fixing and pressurizing: Align the bag bottom plate (3) coated with adhesive with the adhesive layer (2), and gently press the two together; pressurizing can be performed using a press machine, manual pressing, or adding weights to ensure that the two surfaces can maintain good contact during the curing process of the adhesive, thereby ensuring the stability of the joint; the time and pressure of pressurizing should be adjusted according to the curing requirements of the selected adhesive; ④ Curing process: The curing process of adhesives may be chemical reaction type (such as epoxy resin glue) or physical reaction type (such as silicone glue); for epoxy resin glue, it usually needs to be cured for a certain period of time at room temperature, or accelerated curing under heating conditions; for acrylic glue or silicone glue, ultraviolet irradiation or natural air curing may be required; ensure that the adhesive is completely cured before subsequent operations; 3. Post-fixation processing and inspection Cross-section inspection: After fixing is completed, take samples to inspect the cross-section of the joint to ensure that the adhesive is evenly applied and there are no bubbles or defects. The joint surface can be carefully analyzed by microscope or scanning electron microscope (SEM) to ensure that there is no delamination between the adhesive layer and the substrate. Durability test: by simulating the actual wearing environment, durability tests are carried out for a certain period of time; these tests may include adhesion evaluation under temperature and humidity changes, tensile tests, shear force tests, etc., to ensure that in actual use, the bonding between the adhesive layer (2) and the bag bottom plate (3) does not loosen or fail; Through the above steps, the adhesive layer (2) and the bag bottom plate (3) are fixed together using a high-performance adhesive, which not only ensures the stability of the product, but also ensures the use effect of the ostomy bag under the premise of ensuring biocompatibility and environmental adaptability; appropriate adhesive selection and optimized fixing process ensure the long-term stable combination between the adhesive layer (2) and the bottom plate of the ostomy bag, thereby improving the reliability of the product and the comfort of the patient when using it.

Images