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CN-121971219-A - Ostomy chassis and manufacturing method

CN121971219ACN 121971219 ACN121971219 ACN 121971219ACN-121971219-A

Abstract

The application relates to an ostomy chassis which is characterized by comprising a laminating layer, a buffer layer and a buffering layer, wherein the middle part of the laminating layer is provided with a through hole which is matched with the ostomy size, the inner surface of the laminating layer is provided with textures, the rigidity of the laminating layer is gradually distributed from the edge of the stoma to the peripheral direction, the rigidity of the contact part of the laminating layer and a concave area of the skin surface is lower than that of a flat area adjacent to the periphery of the laminating layer, the rigidity of the edge of the laminating layer is higher than that of the flat area adjacent to the periphery of the laminating layer, and the buffering layer is provided with a porous structure. According to the application, through the synergistic design of the rigidity gradient of the attaching layer and the softening of the local concave area and the edge hardening, the attaching layer can be accurately adapted to the unique abdomen curved surface and the skin microscopic topography of a patient, and the design can realize dynamic deformation matching when the patient breathes and moves, so that the problem of excrement leakage caused by static non-attaching and dynamic gaps is eliminated, and complications such as skin inflammation and infection caused by the problems are fundamentally prevented.

Inventors

  • XU LIFEN
  • LI YANYAN
  • HU YING

Assignees

  • 华中科技大学同济医学院附属协和医院

Dates

Publication Date
20260505
Application Date
20260202

Claims (10)

  1. 1. An ostomy chassis, which comprises a base plate and a pair of side plates, characterized by comprising the following steps: The middle part of the laminating layer is provided with a through hole matched with the size of the stoma, the inner surface of the laminating layer is provided with textures, the rigidity of the laminating layer is distributed in a gradient decreasing manner from the edge of the stoma to the peripheral direction, the rigidity of the contact part of the laminating layer and the concave area of the skin surface is lower than that of the adjacent flat area around the laminating layer, and the rigidity of the edge of the laminating layer is higher than that of the adjacent flat area around the laminating layer; The buffer layer with porous structure, the buffer layer set up in the laminating layer outside and with laminating layer integrated into one piece, the buffer layer includes first region, second region and the third region that the porosity is progressively increased in proper order.
  2. 2. The ostomy chassis of claim 1, wherein the bonding layer is a medical silicone-based composite layer, the thickness of the bonding layer is 0.3 mm-0.5 mm, the texture depth is 50-100 μm, and an antibacterial component is arranged in the bonding layer.
  3. 3. The ostomy chassis of claim 2, wherein the antimicrobial structures are nano-silver particles.
  4. 4. The ostomy chassis of claim 1, wherein the buffer layer is a porous polyurethane elastic layer, and the thickness of the buffer layer is 1 mm-2 mm.
  5. 5. The ostomy chassis of claim 1, further comprising: A sensing circuit disposed inside the buffer layer, the sensing circuit including a pressure sensing array disposed around the through-hole and/or a humidity sensing unit disposed in an expected seepage accumulation area; The fixed layer is arranged on the outer side of the buffer layer and the sensing circuit, and a wireless transmission module connected with the sensing circuit is arranged in the fixed layer.
  6. 6. The ostomy chassis of claim 5, wherein the pressure sensing array comprises a plurality of radially distributed star-shaped electrode pairs, the electrode material of the star-shaped electrode pairs being a flexible conductive polymer doped with carbon nanotubes; The humidity sensing unit comprises an interdigital electrode and a hydrophilic polymer layer wrapping the interdigital electrode.
  7. 7. A method of manufacturing an ostomy chassis based on claim 1, comprising the steps of: acquiring three-dimensional form data of a stoma and a surrounding abdominal region of a patient, generating a skin digital model based on the three-dimensional form data, and generating a stoma chassis basic volume model by taking the skin digital model as a reference surface and outwards biasing a preset thickness; Defining a fitting layer in an inner region of the basic volume model by taking an edge of a stoma in the skin digital model as a geometric reference, and planning a spatial rigidity distribution, wherein the spatial rigidity distribution is configured to be gradually reduced from the edge of the stoma to a preset rigidity value in the peripheral direction; defining a buffer layer region in the basic volume model outside the attaching layer, performing topological optimization on the buffer layer region based on stress distribution data obtained by finite element mechanical simulation on the skin digital model, and generating a buffer layer model comprising the first region, the second region and the third region; Adopting a light curing printing process based on energy field spatial modulation, and integrally forming the lamination layer according to the spatial rigidity distribution data of the lamination layer; and adopting a deposition printing process, and depositing an elastomer material according to the buffer layer model to integrally form the buffer layer.
  8. 8. The method of making an ostomy chassis of claim 7, wherein the ostomy chassis further comprises: A sensing circuit disposed inside the buffer layer, the sensing circuit including a pressure sensing array disposed around the through-hole and/or a humidity sensing unit disposed in an area where seepage is expected to accumulate; the fixed layer is arranged outside the buffer layer, and a wireless transmission module connected with the sensing circuit is arranged in the fixed layer; The hierarchical design further includes: Designing an embedded sensing circuit at a preset depth of the buffer layer model, wherein the sensing circuit comprises a pressure sensing array arranged around a stoma and humidity sensing units distributed in an expected seepage accumulation area, and planning a lead path connected to the edge of the buffer layer; and designing a fixed layer, namely designing a fixed layer area outside the buffer layer model.
  9. 9. The method of manufacturing an ostomy chassis of claim 8, wherein, when depositing an elastomeric material to integrally form a cushioning layer in accordance with the cushioning layer model, further comprising: Synchronously executing a first printing path and a second printing path by adopting a multi-material deposition printing process, depositing an elastomer material along the first printing path to construct the buffer layer, and simultaneously depositing a conductive functional material along the second printing path at a design position corresponding to the sensing circuit, so that the sensing circuit conformally embedded is formed in situ while the buffer layer is printed; And depositing packaging materials to cover and protect the buffer layer and the sensing circuit, forming a fixed layer, and integrating a wireless transmission module electrically connected with the sensing circuit in the edge area of the fixed layer.
  10. 10. The method of claim 8, wherein the spatially distributing the stiffness further comprises adjusting the spatial stiffness distribution of the conformable layer such that the predetermined stiffness value is lower for the skin fold region than for the adjacent planar region therearound and higher for the contoured edge seal region than for the adjacent planar region therearound.

Description

Ostomy chassis and manufacturing method Technical Field The invention relates to the technical field of ostomy chassis design, in particular to a ostomy chassis and a manufacturing method thereof. Background Ostomy is a common means for treating diseases such as intestinal tracts, urinary bladder and the like, postoperative patients need to be connected with an ostomy bag through a ostomy chassis, excrement collection and management are achieved, and the suitability, comfort and tightness of the ostomy chassis directly influence the life quality of the patients and postoperative recovery. At present, most of clinically used ostomy chassises are standardized mass production products, the skin form around a patient's stoma, the size and the position of the stoma are obviously different from each other, the standardized chassises are difficult to completely attach to a skin curved surface, gaps are easy to appear, excrement leakage is caused, skin inflammation, infection and other complications are caused, about 35% of ostomy patients are damaged due to the fact that the chassises are attached to the patient according to clinical data statistics, the existing chassises are mainly made of uniform medical adhesive layers and base materials, parameters such as hardness, elasticity and air permeability of the existing chassises are fixed, dynamic adjustment according to the individual differences of the patients is difficult to be carried out, for example, materials with lower sensitivity are difficult to provide for patients with sensitive skin, and problems such as skin swelling, itching and uncomfortable feeling of pressure or unexpected falling of the chassises are difficult to provide for patients with large activity, and for patients with complicated special body types or stoma forms, the traditional customizing chassises are required to be manually mapped, model manufacturing procedures are generally long for 7-15 days, emergency use requirements of the patients are difficult to meet, and therefore a new manufacturing scheme is required to be designed for solving the problems. Disclosure of Invention The application provides an ostomy chassis and a manufacturing method thereof, which can realize rapid and accurate personalized adaptation and have the adjusting capability of dynamic comfort. In a first aspect, embodiments of the present application provide an ostomy chassis comprising: The middle part of the laminating layer is provided with a through hole matched with the size of the stoma, the inner surface of the laminating layer is provided with textures, the rigidity of the laminating layer is distributed in a gradient decreasing manner from the edge of the stoma to the peripheral direction, the rigidity of the contact part of the laminating layer and the concave area of the skin surface is lower than that of the adjacent flat area around the laminating layer, and the rigidity of the edge of the laminating layer is higher than that of the adjacent flat area around the laminating layer; The buffer layer with porous structure, the buffer layer set up in the laminating layer outside and with laminating layer integrated into one piece, the buffer layer includes first region, second region and the third region that the porosity is progressively increased in proper order. With reference to the first aspect, in one embodiment, the bonding layer is a medical silicone-based composite layer, the thickness of the bonding layer is 0.3 mm-0.5 mm, the texture depth is 50 μm-100 μm, and an antibacterial component is disposed in the bonding layer. With reference to the first aspect, in one embodiment, the antimicrobial structure is a nano silver particle. With reference to the first aspect, in one embodiment, the buffer layer is a porous polyurethane elastic layer, and the thickness of the buffer layer is 1 mm-2 mm. With reference to the first aspect, in an implementation manner, the method further includes: A sensing circuit disposed inside the buffer layer, the sensing circuit including a pressure sensing array disposed around the through-hole and/or a humidity sensing unit disposed in an expected seepage accumulation area; The fixed layer is arranged on the outer side of the buffer layer and the sensing circuit, and a wireless transmission module connected with the sensing circuit is arranged in the fixed layer. With reference to the first aspect, in one embodiment, the pressure sensing array includes a plurality of radial star-shaped electrode pairs, and an electrode material of the star-shaped electrode pairs is a flexible conductive polymer doped with carbon nanotubes; The humidity sensing unit comprises an interdigital electrode and a hydrophilic polymer layer wrapping the interdigital electrode. In a second aspect, an embodiment of the present application provides a manufacturing method based on an ostomy chassis, including the steps of: acquiring three-dimensional form data of a stoma and a surrounding abdomin