Adhesive chassis and manufacturing process
By employing an alternating composite structure of silicone gel and hydrocolloid layers and an extended outer ring design in the stoma tray, the problems of easy corrosion and poor adhesion of the stoma tray have been solved, achieving improved corrosion resistance and adhesion, reducing the risk of leakage, and improving the quality of life for patients.
Patent Information
- Application Number
- CN202511391225.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-26
- Publication Date
- 2025-11-04
AI Technical Summary
Existing stoma trays are easily corroded by excrement and do not adhere firmly, leading to the risk of skin maceration and leakage, and cannot meet the requirements for corrosion resistance and adhesion for long-term use.
It adopts a multi-layered composite structure with alternating silicone gel and hydrocolloid layers, and designs an outer extension structure. The silicone gel layer contacts the skin to provide corrosion resistance and sealing, the hydrocolloid layer provides cushioning protection, and the outer extension structure enhances adhesion.
It significantly improves the service life and adhesion of stoma trays, reduces the risk of leakage, prevents fecal dermatitis, and improves the quality of life for patients.
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Figure CN120884420A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of medical devices, in particular to a viscous adhesive base plate and a manufacturing process. BACKGROUND
[0002] The existing stoma adhesive plate is mainly of hydrogel material. When the stoma bag is used by a stoma therapist or a patient, it is cut and pasted around the stoma. The stoma excretions flow into the connected stoma bag through the cutting hole for collection. The patient discharges or replaces the bag when the excretions collected in the bag reach a certain degree according to personal habits. However, the existing stoma bag has several defects.
[0003] 1. The stoma adhesive plate is usually made of hydrogel material containing a large amount of high-molecular water-absorbing substances. After the hydrogel is cut, it is pasted around the stoma. The stoma excretions will continuously contact the cutting section or the inner circle section, causing continuous corrosion until swelling or dissolving. The stoma patient needs to use it for a long time, which will cause the skin around the stoma to be immersed, causing fecal water dermatitis.
[0004] 2. The stoma adhesive plate usually needs to bear about 1 kg of excretions. The adhesive plate and the skin need a lot of friction and adhesion to ensure that the excretions do not slide down after being transferred. The traditional adhesive plate is made of different formulations of hydrogel with equal thickness or thin edges. Equal thickness is easy to cause the edges to rise, reducing the contact area between the adhesive plate and the skin and increasing the probability of sliding. Thin edges can reduce the edge lifting. When the skin around the stoma is uneven, the thin adhesive layer is not enough to infiltrate the skin, and the pasting effect is not good, which can easily cause the channel and cause leakage.
[0005] In summary, the existing stoma adhesive plate has the technical problems of not meeting the requirements of corrosion resistance and adhesion. SUMMARY
[0006] The technical problem to be solved by the present application is to provide a viscous adhesive base plate and a manufacturing process to solve the problems of easy corrosion of the stoma adhesive plate by excretions and poor adhesion caused by long-term bearing of heavy objects.
[0007] TECHNICAL SOLUTION
[0008] To solve the above problems, the technical solution provided by the present application is as follows:
[0009] A viscous adhesive base plate comprises a main body layer, the main body layer comprises an inner circle and an outer circle, the inner circle is sleeved in the outer circle, the inner circle is a composite structure, the inner circle comprises a plurality of silicone gel circle layers and a plurality of hydrogel circle layers arranged alternately, the silicone gel circle layer is located at the innermost side of the inner circle, a cutting hole is arranged in the silicone gel circle layer at the innermost side, the outer circle is a hydrogel circle layer, and the outermost side of the inner circle is a silicone gel circle layer.
[0010] Further, the outer ring is provided with an outer ring extension structure at one end, the outer ring extension structure comprises a connecting portion and a thin edge portion, and the connecting portion is connected between the thin edge portion and an outer ring end face.
[0011] Further, the inner diameter of the outer ring extension structure gradually increases from the side close to the outer ring body to the side away from the outer ring body.
[0012] Further, the silicone gel ring layer and the hydrogel ring layer are alternately sleeved, and the hydrogel ring layer of the outer ring covers the outermost silicone gel ring layer of the inner ring.
[0013] Further, the thickness of the thin edge portion of the outer ring extension structure is 0.3-1.5mm, the width of the thin edge portion of the outer ring extension structure is 1-5mm, the diameter of the inner ring is 10-60mm, the width of a single silicone gel ring layer is 0.1-5mm, and the width of a single hydrogel ring layer is 0.1-5mm.
[0014] Further, the other end of the outer ring is provided with an outer ring lip.
[0015] Further, the main body layer is further attached with a backing film and a release layer, the backing film is attached on the outer ring extension structure, and the release layer is attached on the outer ring lip.
[0016] A manufacturing process for manufacturing the adhesive bottom disc is also disclosed, and the hydrogel adhesive layer and the silicone gel adhesive layer are manufactured;
[0017] The manufactured hydrogel adhesive layer and silicone gel adhesive layer are alternately laid;
[0018] The laid hydrogel adhesive layer and silicone gel adhesive layer are wound to obtain a composite adhesive roll layer;
[0019] The composite roll layer is sliced to obtain a plurality of single pieces;
[0020] One end of the outer ring layer pure hydrogel portion on the single piece is heated and calendered, and an outer ring lip is arranged at the other end.
[0021] The obtained main body layer is respectively attached with a backing film and a release layer.
[0022] Further, the length of the alternately laid hydrogel adhesive layer and silicone gel adhesive layer gradually decreases.
[0023] Further, the composite adhesive roll layer is covered with a release material and is placed in a refrigeration chamber for refrigeration.
[0024] Advantages
[0025] Compared with the prior art, the technical scheme provided by the present application has the following advantages:
[0026] The stomal nursing device adopts an innovative multi-layer composite structure design, and forms a composite protection system through alternately arranged silicone gel ring layers and hydrocolloid ring layers. Medical staff can accurately cut the innermost silicone gel ring layer and the adjacent hydrocolloid ring layer according to the actual size of the stomal of the patient, which can effectively solve the defect that the traditional hydrocolloid stomal adhesive disc is easily corroded by excretion. The silicone gel layer, as the excretion passage directly contacting the stoma, has excellent corrosion resistance and sealing performance, significantly prolonging the service life of the base; at the same time, the hydrocolloid ring layer provides good buffering and protection, and the double protection mechanism greatly reduces the risk of stomal leakage, thereby effectively preventing the occurrence of fecal water dermatitis. In addition, the device is specially designed with an outer ring extension structure, and the unique thin edge processing process significantly enhances the overall adhesion, which can better resist the phenomenon of adhesive disc sliding down caused by the gravity of excretion, and greatly improves the adhesion firmness. This structure optimization significantly reduces the probability of the base falling off from the skin matrix, providing a more safe and reliable stomal nursing solution for patients, greatly improving the life quality and convenience of patients. BRIEF DESCRIPTION OF DRAWINGS
[0027] Fig. 1 is a side view of embodiment 1 of the present application;
[0028] Fig. 2 is a top view of embodiment 1 of the present application.
[0029] 1, main layer; 2, outer ring extension structure; 3, hydrocolloid ring layer; 4, silicone gel ring layer;
[0030] 5, cutout; 6, outer ring lip; DETAILED DESCRIPTION
[0031] In order to make the technical scheme of the present application clearer, the present application will be further described in detail below in combination with the drawings and specific embodiments.
[0032] Embodiment 1
[0033] In combination with the drawings Figs. 1-2 , a sticky adhesive disc, comprising a main layer 1, the main layer 1 is a paste layer, the main layer 1 is divided into an inner ring and an outer ring, the inner ring and the outer ring are both annular structures, the inner ring is a multi-layer composite structure composed of multiple annular rings nested together, and the inner ring is nested inside the outer ring.
[0034] The outer ring is made of hydrogel, and the outer ring is composed of an outer ring body and an outer ring extension structure 2. The outer ring body is a ring structure, and the outer ring extension structure 2 is an outwardly expanding structure integrally arranged on one side of the outer ring body. The outer ring extension structure 2 is gradually outwardly expanded from the annular end face of the outer ring body. The inner diameter of the outer ring extension structure 2 gradually increases from the side close to the outer ring body to the side away from the outer ring body, and the thickness of the outer ring extension structure 2 also gradually decreases outwardly.
[0035] The outer ring extension structure 2 includes a connecting portion and a thin edge portion. The thin edge portion is used to contact the base body of the adhesive bottom disc, so as to fix the adhesive bottom disc on the base body. The connecting portion is used to connect and transition between the outer ring end face and the thin edge structure. The thickness of the thin edge structure is smaller than that of the outer ring body. The outer ring extension structure 2 combined with the connecting portion and the thin edge portion is a mushroom-shaped structure or a suction disc-shaped structure. The outer ring can be connected with the stable base body through the outer ring extension structure 2.
[0036] The thin edge structure of the outer ring extension structure 2 can well adapt to the roughness of the base body, so as to ensure effective contact and prevent edge lifting. The thin edge structure can effectively reduce stress concentration and reduce and prevent the formation and development of cracks between the contact surfaces of the thin edge structure. The separation tendency of the contact interface tends to be transmitted from the center to the periphery of the thin edge structure. Therefore, the thin edge structure can be slightly deformed under tension to form a small vacuum cavity, generate additional vacuum suction force, and improve adhesion. Compared with the structure in which the separation tendency of the conventional flat end structure is transmitted from the edge to the center, the outwardly expanded thin edge structure can generate additional vacuum suction force, which is up to 10% of the total adhesion.
[0037] The ring structure of the outer ring body is a hollow structure. The cavity reserved in the outer ring body is used to install the inner ring. The outer ring body and the outer ring extension structure 2 are both made of hydrogel.
[0038] The inner ring is composed of alternating ring structures, which are formed by alternately sleeving a silica gel ring layer 4 and a hydrogel ring layer 3. The silica gel ring layer 4 and the hydrogel ring layer 3 are both ring structures, and only differ in outer diameter and inner diameter.
[0039] The ring layer located on the outermost side of the inner ring and in contact with the inner surface of the outer ring body of the outer ring is a silica gel ring layer 4. The inner side of the outermost silica gel ring layer 4 is a hydrogel ring layer 3. Then, a new silica gel ring layer 4 is arranged in the hydrogel ring layer 3, and so on. The hydrogel ring layer 3 and the silica gel ring layer 4 are alternately arranged. The ring layer located on the innermost side of the inner ring is a silica gel ring layer 4. The inner part of the silica gel ring layer located on the innermost side is a shear hole 5. The shear hole 5 penetrates the inner ring. The shear hole 5 is a reserved drainage hole. The excrement is discharged through the shear hole 5.
[0040] In actual use, the user can cut the inner ring by himself / herself to change the inner diameter of the cut hole 5, so as to obtain the most suitable discharge hole for the patient. When cutting the inner ring, cut from the inside to the outside, and each time cut from the innermost layer of the silicone gel ring layer 4 to the next layer of the silicone gel ring layer 4, and the discharge hole needs to be kept in the annular silicone gel ring layer 4, and the excrement discharged from the discharge hole directly contacts the silicone gel ring layer 4.
[0041] By alternately arranging the silicone gel ring layer 4 and the hydrocolloid ring layer 3, the medical staff can cut the inner ring according to the stoma size of the patient to adjust the size of the cut hole 5 to correspond to the stoma size. When cutting, cut from the silicone gel ring layer 4 of the initial ring layer to the silicone gel ring layer 4 of the appropriate size. After cutting, the inner surface in contact with the stoma excrement is silicone gel, which has the advantages of not absorbing water and good corrosion resistance, and is not easy to be corroded by excrement, thereby reducing the risk of long-term excrement leakage.
[0042] The thickness of the thin edge of the outer ring extension structure 2 is 0.3-1.5 mm, the width of the mushroom-shaped thin edge structure is 1-5 mm, and the mushroom-shaped thin edge structure is uniformly distributed in the outer ring layer; the diameter of the inner ring formed by the alternation of the silicone gel and the hydrocolloid is 10-60 mm, the width of the single silicone gel ring layer 4 is 0.1-5 mm, and the width of the single hydrocolloid ring layer 3 is 0.1-5 mm.
[0043] Preferably, the thickness of the thin edge of the outer ring extension structure 2 is 0.6 mm, the width of the mushroom-shaped thin edge structure is 3 mm, the diameter of the inner ring formed by the alternation of the silicone gel and the hydrocolloid is 50 mm, the width of the single silicone gel ring layer 4 is 3 mm, and the width of the single hydrocolloid ring layer 3 is 2 mm.
[0044] One side of the two end faces of the outer ring is provided with the outer ring extension structure 2, and the other side is provided with the outer ring lip 6. The outer ring lip 6 is used in cooperation with the excrement collecting component such as the waist urine bag. The waist urine bag can be installed on the adhesive bottom disc through the outer ring lip 6, so that the excrement directly flows into the waist urine bag through the cut hole 5.
[0045] In addition to the main body layer 1, the adhesive bottom disc further includes a backing film and a release layer which are attached to the main body layer 1. The backing film is attached to the outer ring extension structure 2. When the outer ring extension structure 2 is used to fix the adhesive bottom disc on the base body, the backing film attached to the outer ring extension structure 2 is removed. The backing film covers the outer ring extension structure 2 when the adhesive bottom disc is not in use, preventing the outer ring extension structure 2 from being contaminated, thereby preventing the patient from feeling uncomfortable when contacting the outer ring extension structure 2 when pasted on the base body.
[0046] The release layer is attached to the outer lip 6, and the outer lip 6 has adhesion on the side away from the outer body. The release film is attached to the outer lip 6 on the side with adhesion. When the waist urine bag needs to be installed, the release paper on the outer lip 6 is removed, the waist urine bag is installed on the outer lip 6, and the waist urine bag is adhered to the outer lip 6 to prevent the waist urine bag from falling off.
[0047] The backing layer is one of a PE film, an EVA film or an EMA film; and the release layer is release paper or a release film.
[0048] A manufacturing process of a viscose bottom disc, specifically comprising:
[0049] Manufacturing a hydrocolloid glue layer and a silicone gel glue layer;
[0050] Alternately laying the manufactured hydrocolloid glue layer and silicone gel glue layer;
[0051] Winding the laid hydrocolloid glue layer and silicone gel glue layer to obtain a composite glue roll layer;
[0052] Slicing the composite roll layer to obtain a plurality of single pieces;
[0053] Heating and calendering one end of the outer ring layer hydrocolloid part on the single piece, and setting an outer lip on the other end;
[0054] Attaching a backing film and a release layer to the obtained main body layer.
[0055] Specifically:
[0056] The hydrocolloid is shaped into a hydrocolloid glue layer with uniform thickness by a press roller forming machine, and the silicone gel is coated into a silicone gel glue layer with uniform thickness by a coating machine. Multiple hydrocolloid glue layers and silicone gel glue layers with different lengths need to be prepared. Since the hydrocolloid glue layer and the silicone gel glue layer are alternately arranged in the subsequent process, if the lengths of the hydrocolloid glue layer and the silicone gel glue layer are the same, the complete annular structure cannot be formed by winding.
[0057] The two glue layers are compounded by a compound machine, and the two glue layers are alternately laid and wound to form a composite glue roll layer, wherein the hydrocolloid layer is located on the outer side, and the silicone gel layer is located on the inner side.
[0058] The water gel adhesive layer as the outer ring is laid on the bottom layer, and then the length-reduced silicone gel adhesive layer is laid on the water gel adhesive layer on the bottom layer, and the silicone gel adhesive layer and the water gel adhesive layer are on the same side; then a water gel adhesive layer is laid again on the silicone gel adhesive layer laid on the bottom water gel adhesive layer, and at this time, the length of the water gel adhesive layer on the third layer from bottom to top is shorter than that of the silicone gel adhesive layer on the second layer from bottom to top, and so on, so as to complete the alternating composite of the two adhesive layers, and the adhesive layer on the uppermost side is the silicone gel adhesive layer.
[0059] The laid layers are aligned at the same end, and the aligned end is used as the starting point of winding, so that the adhesive layers are wound around the roller, the roller is coated with a release agent to facilitate taking down the wound composite adhesive roll layer, and the diameter of the roller used for winding is the diameter of the inner ring cutout.
[0060] Then, the wound composite adhesive roll layer is covered with a release material and placed in a freezer for refrigeration to fix its shape.
[0061] The cooled composite adhesive roll layer is removed from the center of the roller, and slicing is performed with a slicing machine, so as to obtain a plurality of single pieces, and the single piece presents that the inner ring part in the middle is a multi-layer alternating distribution of silicone gel and water gel interactive layers, and the outer ring is a pure water gel layer. The hollow center part of the wound composite adhesive roll layer after the roller is removed is the cutout for excretion.
[0062] The outer ring layer of the pure water gel part is heated and calendered to form an outer ring extension structure, and the outer ring lip is fixed at the other end at the same time.
[0063] The single piece is attached to the backing layer and the release layer, the backing layer is attached to the outer ring extension structure, and the release layer is attached to the outer ring lip.
[0064] Specific implementation: a water gel adhesive block is made by a mixing process, and the water gel adhesive block is extruded into a uniform adhesive layer with a thickness of 0.1-5 mm by a compression roller forming machine and is wound with a release film to obtain a water gel adhesive layer. The silicone gel is coated by a solvent adhesive coating machine to obtain a silicone gel adhesive layer with a thickness of 0.1-5 mm. The water gel adhesive layer and the silicone gel adhesive layer are covered with a release film for easy storage and can be used at any time.
[0065] The side of the water gel adhesive layer and the side of the silicone gel adhesive layer are stripped off by a stripping laminating machine, and the exposed surface of the water gel adhesive layer and the exposed surface of the silicone gel adhesive layer are adhered together by a laminating roller, and so on, so as to form a multi-layer alternating arrangement structure.
[0066] The multi-layer composite water gel adhesive layer and silicone gel adhesive layer are wound around a roller coated with a release agent with a diameter of 1.5 mm, and the adhesive layers are continuously rolled and wound, wherein the length of the water gel layer and the silicone gel layer arranged alternately gradually shortens, and the wound adhesive roll is observed from the cross section, and the inner circle of the silicone gel layer and the water gel layer are interlaced with each other, and the outer circle is a pure water gel, wherein the maximum diameter of the inner circle composed of the silicone gel adhesive layer and the water gel adhesive layer is 10-70 mm, and the outermost diameter of the outer circle of the pure water gel layer is 110-150 mm. The wound adhesive roll is wrapped with a release material and placed in a freezer at minus 20℃ for freezing for 2-4 hours, so that the structure of the formed composite adhesive roll layer is kept stable, the center roller is removed, and a slicing machine is used to slice, and the pure water gel part of the outer circle layer is heated and calendered synchronously during the process of adhering the backing layer and the release layer, the outer circle extension structure is formed through the calendering die, and the backing layer and the release layer are adhered on the outer circle.
[0067] The above embodiments only express several embodiments of the present application, and the description is more specific and detailed, but it cannot be understood as a limitation on the scope of the patent of the present application. It should be noted that for ordinary skilled in the art, without departing from the concept of the present application, several modifications and improvements can be made, which belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.
Claims
1. An adhesive chassis, characterized in that, The system includes a main body layer, which comprises an inner ring and an outer ring. The inner ring is fitted inside the outer ring and has a composite structure. The inner ring includes several alternating silicone gel rings and several hydrocolloid rings. The silicone gel rings are located on the innermost side of the inner ring and have shear holes. The outer ring is a hydrocolloid ring, and the outermost side of the inner ring is a silicone gel ring.
2. The adhesive chassis according to claim 1, characterized in that, The outer ring is composed of an outer ring body and an outer ring extension structure. The outer ring extension structure is disposed on one side of the outer ring body. The outer ring extension structure includes a connecting part and a thin edge part. The connecting part connects the thin edge part and the outer ring end face.
3. The adhesive chassis according to claim 2, characterized in that, The inner diameter of the outer ring extension structure gradually increases from the side closer to the outer ring body to the side farther away from the outer ring body.
4. The adhesive chassis according to claim 2, characterized in that, The silicone gel layer and the hydrocolloid layer are alternately nested, with the outermost hydrocolloid layer covering the outermost silicone gel layer of the inner circle.
5. The adhesive chassis according to claim 4, characterized in that, The thickness of the thin edge portion of the outer ring extension structure is 0.3-1.5mm, the width of the thin edge portion of the outer ring extension structure is 1-5mm, the diameter of the inner ring is 10-60mm, the width of the single ring of the silicone gel ring is 0.1-5mm, and the width of the single ring of the hydrocolloid ring is 0.1-5mm.
6. The adhesive chassis according to claim 5, characterized in that, The other end of the outer ring is provided with an outer ring lip.
7. The adhesive chassis according to claim 6, characterized in that, A backing film and a release layer are also attached to the main body layer. The backing film is attached to the outer ring extension structure, and the release layer is attached to the outer ring lip.
8. A manufacturing process for producing the adhesive chassis according to any one of claims 1-7, characterized in that, Fabrication of hydrocolloid and silicone gel layers; The prepared hydrocolloid layer and silicone gel layer are laid alternately; The laid hydrocolloid adhesive layer and silicone gel adhesive layer are wound together to obtain a composite film roll layer; The composite interleaved layer is sliced to obtain several individual slices; One end of the pure water colloid portion of the outer ring layer on the single sheet is heated and calendered, and an outer ring lip is set at the other end; A backing film and a release layer are then bonded onto the obtained main body layer.
9. The manufacturing process of an adhesive chassis according to claim 8, characterized in that, The alternating hydrocolloid layers and silicone gel layers gradually shorten in length.
10. The manufacturing process of an adhesive chassis according to claim 9, characterized in that, The composite film layer is coated with release material and placed in a freezer for refrigeration.
