A cut-to-size free shapeable hydrocolloid ostomy base and ostomy pouch

Abstract

The utility model provides a kind of cutting-free shapeable hydrocolloid stoma base plate and stoma bag, including release layer, hydrocolloid layer and flexible film layer;Release layer is attached to one side of hydrocolloid layer, and flexible film layer is attached to the other side of hydrocolloid layer;Flexible film layer covers the entire hydrocolloid layer to correspond to construct a whole shapeable structure, and a drainage port is provided on the shapeable structure for stoma to pass through;Flexible film layer is configured to provide elastic force to shapeable structure, so that shapeable structure is deformed under the action of external force, to change the size of drainage port;Elastic film layer does not fully rebound to original size, can maintain the shape after deformation within a certain range, ensure that drainage port maintains the required opening in clinical use, and does not shrink excessively due to abdominal wall movement or body position change, and the elastic film layer is stretched to adhere to the edge of hydrocolloid layer, and is attached to skin together, effectively blocking external pollution and leakage liquid.

Description

Technical Field

[0001] This utility model relates to the field of ostomy bag technology, specifically to a cut-free, malleable hydrocolloid ostomy base plate and its ostomy bag. Background Technology

[0002] In stoma care, baseplates are often made of hydrocolloid materials to provide both skin adhesion and leak prevention. However, existing hydrocolloid stoma baseplates have non-adjustable drainage port sizes. Most products have the drainage port opening size set during manufacturing, making it difficult to adjust on-site for different stoma diameters or postoperative abdominal distension. In particular, they lack elastic deformation mechanisms, making the baseplate more prone to stress concentration when the tissues around the stoma are stretched due to movement or changes in body position, leading to adhesion failure or skin damage. Utility Model Content

[0003] In view of this, the purpose of this utility model is to provide a cut-free, malleable hydrocolloid stoma base plate and its stoma bag to solve the above problems.

[0004] The present invention adopts the following solution: This application provides a cut-free, malleable hydrocolloid stoma baseplate, comprising a release layer, a hydrocolloid layer, and a flexible film layer; the release layer is attached to one side of the hydrocolloid layer, and the flexible film layer is attached to the other side of the hydrocolloid layer; the flexible film layer covers the entire hydrocolloid layer to form a malleable structure, and the malleable structure has a drainage port for the stoma to pass through; the flexible film layer is configured to provide elasticity to the malleable structure so that the malleable structure can deform under external tearing force, thereby changing the size of the drainage port.

[0005] As a further improvement, the flexible film layer is an elastic membrane with inherent stretchability and flexibility.

[0006] As a further improvement, the elastic membrane is made of LDPE, TPU, LLDPE, HDPE, BOPP, CPP, PVC or EVA.

[0007] As a further improvement, the thickness of the elastic membrane is 0.01 mm to 0.06 mm.

[0008] As a further improvement, the elongation of the elastic membrane is 200% or more.

[0009] As a further improvement, the flexible film layer forms a shaping surface on the hydrocolloid layer in a stacked attachment manner, which is used to further provide a malleable elastic force after the drainage port is stretched and deformed to change size.

[0010] As a further improvement, the malleable structure is a ring-shaped or circular structural layer, and the release layer is attached and covered on the lower surface side in a stacked and attached manner.

[0011] As a further improvement, the drainage port is located at the center of the malleable structure.

[0012] This application also provides an ostomy bag, including a bag body and a cut-free, malleable hydrocolloid ostomy base plate as described above.

[0013] By adopting the above technical solution, the present invention can achieve the following technical effects: 1. The cut-free, malleable hydrocolloid stoma base plate of this application has a malleable structure that deforms after being torn by external force. Its elastic film layer provides elastic force to further reshape the malleable structure, while the flexible film layer further enhances the elasticity. The size of the drainage port can be freely adjusted by tearing and deforming the structure to meet the needs of different stoma diameters and postoperative abdominal distension changes. Moreover, the flexible film layer can stretch and absorb energy under external force, reduce stress concentration, absorb some energy at the moment of stretching, play a buffering role, and improve the tear resistance of the entire base plate.

[0014] 2. After being released, the elastic film layer will not fully rebound to its original size, but will maintain its deformed shape within a certain range, ensuring that the drainage port maintains the required opening during clinical use and will not shrink excessively due to abdominal wall movement or changes in body position. Moreover, after being stretched, the elastic film layer adheres tightly to the edge of the hydrocolloid layer and is attached to the skin together to form a continuous sealing surface, effectively blocking external contamination and leakage. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the structure of the cut-free, malleable hydrocolloid stoma base plate according to an embodiment of the present invention; Figure 2 yes Figure 1 A schematic diagram of the structure after the drainage port has been torn and resized. Figure 3 This is a cross-sectional view of the cut-free, malleable hydrocolloid stoma base of this utility model embodiment; Figure 4 This is a schematic diagram of the deformation of the malleable structure of the no-cut malleable hydrocolloid stoma chassis according to an embodiment of the present invention under external tearing force. Figure 5 and Figure 6 This is an application scenario diagram of the no-cut, malleable hydrocolloid stoma chassis according to an embodiment of this utility model.

[0016] icon: 1-Ostomy base plate; 2-Release layer; 3-Hydrocolloid layer; 4-Flexible film layer; 5-Drainage port. Detailed Implementation

[0017] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model. Therefore, the following detailed description of the embodiments of this utility model provided in the accompanying drawings is not intended to limit the scope of the claimed utility model, but merely to represent selected embodiments of this utility model. Example

[0018] Combination Figures 1 to 6 This embodiment provides a cut-free, malleable hydrocolloid stoma base plate 1, including a release layer 2, a hydrocolloid layer 3, and a flexible film layer 4. The release layer 2 is attached to one side of the hydrocolloid layer 3, and the flexible film layer 4 is attached to the other side of the hydrocolloid layer 3. The flexible film layer 4 covers the entire hydrocolloid layer 3, correspondingly constructing a complete malleable structure, and a drainage port 5 for the stoma to pass through is provided on the malleable structure. The flexible film layer 4 is configured to provide elasticity to the malleable structure, thereby deforming the malleable structure under external tearing force, thus changing the size of the drainage port 5.

[0019] The aforementioned cut-free, malleable hydrocolloid stoma base plate 1 has a malleable structure that deforms after being torn by external force. Its elastic film layer provides elastic force to further reshape the malleable structure, while the flexible film layer 4 further enhances the elasticity. The size of the drainage port 5 can be freely adjusted by tearing and deforming the structure to meet the needs of different stoma diameters and postoperative abdominal distension changes. Furthermore, the flexible film layer 4 can extend and absorb energy under external force, reducing stress concentration. It absorbs some energy during the stretching moment, playing a buffering role and improving the tear resistance of the entire base plate.

[0020] After being released, the elastic film layer will not fully spring back to its original size, but will maintain its deformed shape within a certain range, ensuring that the drainage port 5 maintains the required opening during clinical use and will not shrink excessively due to abdominal wall movement or changes in body position. Furthermore, after being stretched, the elastic film layer adheres tightly to the edge of the hydrocolloid layer 3 and is then attached to the skin to form a continuous sealing surface, effectively blocking external contamination and leakage.

[0021] Preferably, the flexible film layer 4 is an elastic membrane with inherent stretchability and flexibility. Obviously, the elastic membrane itself has a predetermined tensile modulus and can stretch uniformly in all directions under external force. Furthermore, by manually tearing it, a predictable amount of deformation can be generated on the elastic membrane, thereby precisely adjusting the diameter and shape of the drainage port 5 without the need for other structures. In addition, after stretching and deformation, the elastic membrane does not completely return to its original state but remains at a new stress equilibrium point, ensuring that the drainage port 5 stably maintains the required opening during subsequent use.

[0022] Specifically, the elastic membrane is made of LDPE, TPU, LLDPE, HDPE, BOPP, CPP, PVC, or EVA. On one hand, materials such as LDPE, LLDPE, CPP, and EVA have high elongation and controllable tensile modulus, allowing the film layer to stretch uniformly under external tearing force and maintain its opening after deformation. TPU, due to its excellent resilience and shape memory effect, can maintain a predetermined opening after stretching, ensuring the stability of the drainage port 5 size. High-strength materials such as HDPE, PP, and BOPP have tightly packed polymer chains that slide and rearrange during stretching, significantly improving tear resistance. PVC and EVA materials have smooth surfaces, are flexible and conform to skin folds, reducing local shear irritation.

[0023] The thickness of the elastic membrane is between 0.01 mm and 0.06 mm. This ensures that the elastic membrane is thin enough to easily stretch and deform under external tearing force, allowing for flexible shaping adjustment. Preferably, when the thickness is 0.03 mm, the membrane is sufficient to absorb and disperse local stress during stretching, reducing the shear force at the interface between the hydrocolloid layer 3 and the skin.

[0024] The elastic membrane has a tensile strength of over 200%. A tensile strength ≥ 200% indicates that the membrane can withstand an extension at least twice its original length, easily increasing the diameter of the drainage opening to meet various stoma requirements, from small to large diameters. Within this high strain range, the material maintains excellent shape memory: after being stretched to the target opening, it solidifies into a new shape upon release, and does not crack or shrink when the patient moves.

[0025] In this embodiment, the flexible film layer 4 forms a shaping surface on the hydrocolloid layer 3 in a stacked attachment manner. This surface provides a malleable elastic force after the drainage port 5 is stretched and deformed. The stacked attachment ensures a tight bond between the flexible film layer and the hydrocolloid layer 3, allowing both layers to share the stress during tearing deformation and preventing excessive elongation or localized breakage of a single layer. The shaping surface provides a predetermined deformation trajectory, allowing the flexible film to slide uniformly along the hydrocolloid contour during stretching, ensuring smooth edges without sharp corners after the opening expands.

[0026] Furthermore, after being torn and deformed, the flexible film layer 4 can at least form a barrier on the entire outer surface to prevent moisture and impurities from entering or leaving, while the hydrocolloid layer 3 is exposed on the periphery due to deformation, thereby absorbing residual stoma excrement and reducing skin corrosion.

[0027] Furthermore, the malleable structure is a ring-shaped or circular structural layer, and the release layer 2 is attached and covered to the lower surface in a stacked manner. When the release layer 2 is removed, the ring-shaped or circular structural layer immediately adheres to the skin, and the ring edge provides mechanical protection to prevent the chassis from slipping or rotating during body movement.

[0028] In this embodiment, the drainage port 5 is located at the center of the malleable structure. By placing the drainage port 5 at the geometric center of the annular malleable structure, the tensile force in all directions is uniformly transmitted outward through the center during tearing, so that the opening expands to maintain a circular or preset shape, making it less prone to eccentric tearing or irregular deformation.

[0029] In addition, this embodiment provides another ostomy bag, including a bag body and a cut-free, malleable hydrocolloid stoma base plate 1 as described above. The bag body and the malleable base plate fit tightly together, and the elastic annular structure of the base plate and the central adjustable drainage port 5 ensure that the bag opening completely covers the stoma, achieving seamless connection regardless of the stoma location, diameter, or postoperative tissue changes.

[0030] The above are merely preferred embodiments of this utility model. The protection scope of this utility model is not limited to the above embodiments. All technical solutions that fall within the scope of this utility model's concept are protected by this utility model.

Claims

1. A cut-free, malleable hydrocolloid stoma base plate, characterized in that, It includes a release layer, a hydrocolloid layer, and a flexible thin film layer; The release layer is attached to one side of the hydrocolloid layer, and the flexible film layer is attached to the other side of the hydrocolloid layer; The flexible film layer covers the entire hydrocolloid layer to form a complete malleable structure, and the malleable structure is provided with a drainage port for the ostomy to pass through. The flexible film layer is configured to provide elasticity to the malleable structure, thereby deforming the malleable structure under external tearing force to change the size of the drainage port.

2. The non-cutting, malleable hydrocolloid stoma base plate according to claim 1, characterized in that, The flexible film layer is an elastic membrane with inherent stretchability and flexibility.

3. The non-cutting, malleable hydrocolloid stoma base plate according to claim 2, characterized in that, The elastic membrane is made of LDPE, TPU, LLDPE, HDPE, BOPP, CPP, PVC or EVA.

4. The non-cutting, malleable hydrocolloid stoma base plate according to claim 2, characterized in that, The thickness of the elastic membrane is 0.01 mm to 0.06 mm.

5. The non-cutting, malleable hydrocolloid stoma base plate according to claim 2, characterized in that, The elongation of the elastic membrane is 200% or more.

6. The non-cutting, malleable hydrocolloid stoma base plate according to claim 1, characterized in that, The flexible film layer forms a shaping surface on the hydrocolloid layer in a stacked and attached manner, which is used to further provide a malleable elastic force after the drainage port is stretched and deformed to change size.

7. The non-cutting, malleable hydrocolloid stoma base plate according to claim 1, characterized in that, The malleable structure is a ring-shaped or circular structural layer, and the release layer is attached and covered on the lower surface in a stacked and bonded manner.

8. The non-cutting, malleable hydrocolloid stoma base plate according to claim 1, characterized in that, The drainage port is located at the center of the malleable structure.

9. An ostomy bag, characterized in that, Includes a bag body and a cut-free, malleable hydrocolloid stoma base plate as described in any one of claims 1-8.

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