Drainage patch and method of making same

Abstract

The application provides a drainage patch and a manufacturing method thereof. The drainage patch comprises a hydrophilic layer and a hydrophobic layer arranged in a stack, an enzyme storage bin, and a plurality of enzyme flow channels in communication with the enzyme storage bin. The enzyme flow channels are arranged in the hydrophilic layer. Each enzyme flow channel is provided with a plurality of enzyme contact windows along the length direction. The enzyme storage bin is configured to deliver the enzyme inside to the enzyme flow channels, so that the enzyme is exposed to the hydrophilic layer at the enzyme contact windows. The drainage patch and the manufacturing method thereof of the application solve the core problems of poor portability of the existing negative pressure drainage device and difficulty in maintaining the continuous effect of the biological enzyme due to the loss of activity. The one-way wetting structure formed by the hydrophilic layer and the hydrophobic layer cooperates with the capillary force of the enzyme flow channel to realize spontaneous directional drainage without external equipment, completely eliminating the dependence on large negative pressure host and greatly improving the portability of the device. Meanwhile, the sealed enzyme storage bin is matched with the chitosan fixation system to isolate the air and maintain the long-acting activity of the biological enzyme.

Description

Technical Field

[0001] This invention relates to the field of medical supplies technology, and in particular to a drainage patch and its manufacturing method. Background Technology

[0002] Vacuum-assisted closure (VSD / VAC) is a first-line treatment for acute and chronic wounds. It creates a controlled negative pressure environment at the wound site to achieve continuous drainage of wound exudate and pus. At the same time, it can control infection, reduce edema, and promote granulation tissue growth. It is widely used in the field of wound repair.

[0003] However, existing clinical negative pressure drainage devices have significant technical defects. They generally rely on external large negative pressure suction equipment to create a negative pressure environment, which is extremely unportable and limits the patient's range of motion.

[0004] To remove pus from wounds, existing technologies also employ specific biological enzymes (proteases, deoxyribonucleases, mucopolysaccharides, etc.) to enzymatically hydrolyze the pus. These enzymes break down highly viscous macromolecules in the pus into water-soluble small molecules, thus degrading and transforming the pus. However, biological enzymes are relatively unstable and easily deactivated when exposed to air, resulting in a significant decrease in enzymatic hydrolysis efficiency and an inability to continuously remove pus.

[0005] In summary, among the existing wound treatment technologies, drainage devices are not portable and biological enzymes are easily deactivated and have difficulty maintaining their effectiveness. All of these technologies have significant shortcomings and cannot simultaneously meet the clinical needs of efficient pus removal, wound repair without damage, and ease of use.

[0006] In view of this, it is necessary to improve the existing traffic-driving patches to solve the above problems. Summary of the Invention

[0007] The purpose of this invention is to provide a drainage patch to solve the problems of poor portability and easy deactivation of biological enzymes in existing negative pressure drainage devices, which makes it difficult to maintain a sustained effect.

[0008] To achieve the above objectives, the present invention provides a drainage patch comprising a hydrophilic layer and a hydrophobic layer stacked together, an enzyme storage chamber, and a plurality of enzyme channels communicating with the enzyme storage chamber. The enzyme storage chamber is a sealed structure, and the enzyme channels are disposed within the hydrophilic layer. Each enzyme channel has a plurality of enzyme contact windows along its length. The enzyme storage chamber is configured to deliver the enzymes inside to the enzyme channels, so that the enzymes are exposed within the hydrophilic layer at the enzyme contact windows.

[0009] As a further improvement of the present invention, a plurality of the enzyme channels are arranged in a circumferential array around the enzyme storage chamber.

[0010] As a further improvement of the present invention, the enzyme flow channel is connected to the bottom of the enzyme storage chamber.

[0011] As a further improvement of the present invention, the drainage patch further includes a plurality of cell climbing balls disposed within the hydrophilic layer, and each cell climbing ball has a plurality of climbing pits recessed on its surface.

[0012] As a further improvement of the present invention, the cell climbing ball is made of a biodegradable material.

[0013] As a further improvement of the present invention, the hydrophilic layer, enzyme storage chamber, and enzyme flow channel are all made of biodegradable materials.

[0014] As a further improvement of the present invention, the drainage patch further includes an enzyme replenishment chamber, which is connected to the enzyme storage chamber. The enzyme replenishment chamber includes a first part disposed within the hydrophobic layer and a second part connected to the first part and protruding outside the hydrophobic layer. The second part is used to insert into the enzyme storage chamber.

[0015] As a further improvement of the present invention, the enzyme replenishment chamber and the enzyme storage chamber are connected by a snap-fit ​​connection.

[0016] As a further improvement of the present invention, the enzyme replenishment chamber has an inverted frustum-shaped structure, and the cross-sectional area of ​​the side facing the enzyme storage chamber is smaller than the cross-sectional area of ​​the side away from the enzyme storage chamber.

[0017] This invention also provides a method for manufacturing a drainage patch, which achieves the manufacturing of the drainage patch as described above, characterized by comprising the following steps:

[0018] S1: Construct an enzyme storage chamber, an enzyme flow channel, and an enzyme replenishment chamber, wherein an enzyme contact window is formed on the enzyme flow channel;

[0019] S2: A hydrophilic layer is formed outside the enzyme storage chamber and enzyme flow channel during spinning, and cell climbing balls are added during the spinning process;

[0020] S3: A hydrophobic layer is formed by spinning outside the enzyme replenishment chamber;

[0021] S4: Inject enzyme into the enzyme replenishment chamber and snap the enzyme replenishment chamber to the enzyme storage chamber to achieve contact between the hydrophilic layer and the hydrophobic layer.

[0022] As a further improvement of the present invention, step S3 specifically involves: providing a production tooling with a receiving groove, placing the second part in the receiving groove, and then spinning a hydrophobic layer on the outside of the first part.

[0023] The beneficial effects of this invention are as follows: The drainage patch and preparation method of this invention specifically solve the core problems of poor portability and easy inactivation of biological enzymes in existing negative pressure drainage devices, making it difficult to maintain continuous effectiveness. Through the unidirectional moisture-guiding structure composed of hydrophilic and hydrophobic layers combined with the capillary force of the enzyme flow channel, spontaneous directional drainage without external equipment is achieved, completely eliminating the dependence on large negative pressure main units and greatly improving the portability of the device; at the same time, the sealed enzyme storage chamber combined with the chitosan fixation system isolates the biological enzymes from air and keeps them active for a long time. Attached Figure Description

[0024] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings:

[0025] Figure 1 This is a top view of the drainage patch of the present invention;

[0026] Figure 2 This is a side view of the drainage patch of the present invention;

[0027] Figure 3 This is a side cross-sectional view of the drainage patch of the present invention;

[0028] Figure 4 This is a schematic diagram of the enzyme storage chamber, enzyme flow channel, and enzyme replenishment chamber of the drainage patch of the present invention;

[0029] Figure 5 This is a side view of the enzyme storage compartment and enzyme flow channel of the drainage patch of the present invention;

[0030] Figure 6 This is a schematic diagram of the cell climbing ball structure of the drainage patch of the present invention;

[0031] Figure 7 This is a schematic diagram of step S2 of the method for manufacturing the drainage patch of the present invention;

[0032] Figure 8 This is a schematic diagram of step S3 of the method for manufacturing the drainage patch of the present invention;

[0033] Figure 9 This is a flowchart of the method for manufacturing the drainage patch of the present invention.

[0034] Reference numerals: 100, Drainage patch; 1, Hydrophilic layer; 2, Hydrophobic layer; 3, Enzyme storage chamber; 4, Enzyme flow channel; 41, Enzyme contact window; 5, Cell climbing ball; 51, Climbing pit; 6, Enzyme replenishment chamber; 61, Part 1; 62, Part 2; 20, Production tooling. Detailed Implementation

[0035] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0036] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0037] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, the technical features involved in the different embodiments of this invention described below can be combined with each other as long as they do not conflict with each other.

[0038] like Figures 1 to 8 As shown, the drainage patch 100 of the present invention includes a hydrophilic layer 1 and a hydrophobic layer 2 stacked together, an enzyme storage chamber 3, and a plurality of enzyme channels 4 connected to the enzyme storage chamber 3.

[0039] The contact here can be direct contact or indirect contact through a transition layer.

[0040] The enzyme storage chamber 3 is a sealed structure, and it stores biological enzyme preparations with a preservation system, which is a chitosan immobilization system.

[0041] The enzyme channel 4 is disposed within the hydrophilic layer 1. Each enzyme channel 4 has multiple enzyme contact windows 41 along its length. The enzyme storage chamber 3 is configured to transport the enzyme inside to the enzyme channel 4, so that the enzyme is exposed to the hydrophilic layer 1 at the enzyme contact window 41.

[0042] In this embodiment, the enzyme storage chamber 3 is also disposed within the hydrophilic layer 1.

[0043] The hydrophilic layer 1 and the hydrophobic layer 2 together form a composite layer structure with unidirectional moisture-wicking function. The hydrophilic layer 1 is located on the side of the patch closest to the wound surface and has strong capillary water absorption capacity, which can quickly absorb bodily fluids such as pus and exudate from the wound surface. The hydrophobic layer 2 is located on the side of the hydrophilic layer 1 away from the wound surface, forming a hydrophobic barrier and a unidirectional moisture-wicking channel, realizing the core function of "rapid fluid absorption by the hydrophilic layer on the wound side and prevention of backflow by the hydrophobic layer on the flow channel side".

[0044] The enzyme storage chamber 3 contains a specific biological enzyme preparation immobilized with chitosan. The specific biological enzyme includes one or more combinations of protease, deoxyribonuclease, and mucopolysaccharide enzyme. The chitosan immobilization system can maintain the biological activity of the enzyme for a long time, while giving the enzyme preparation a suitable viscosity to avoid uncontrolled leakage.

[0045] One end of each of the multiple enzyme channels 4 is connected to the outlet of the enzyme storage chamber 3, and the other end is arranged inside the hydrophilic layer 1 to achieve uniform distribution of the enzyme preparation throughout the entire patch wound coverage area.

[0046] The enzyme contact window 41 connects the inner cavity of the enzyme channel 4 with the capillary pore structure of the hydrophilic layer 1, allowing the biological enzyme in the enzyme storage chamber 3 to continuously flow into each enzyme channel 4 through pressure difference and capillary action, and slowly exudate through the enzyme contact window 41, making full contact with the wound pus and exudate adsorbed by the hydrophilic layer 1.

[0047] The unidirectional moisture-wicking structure formed by the hydrophilic layer 1 and the hydrophobic layer 2, combined with the capillary action of the enzyme channel 4, achieves continuous and controllable negative pressure drainage without the need for an external large negative pressure unit. This is achieved solely through the material's structural characteristics: the hydrophilic layer 1 rapidly absorbs wound pus and exudate into the patch via capillary action, while the enzymatically hydrolyzed small-molecule liquids are smoothly drained through the unidirectional moisture-wicking channel of the hydrophobic layer 2. Simultaneously, the hydrophobic barrier of the hydrophobic layer 2 prevents backflow of external liquids and secondary contamination of the wound. This design significantly improves the device's portability, allowing patients to move normally and meeting the needs of home and day treatment. It can effectively shorten hospital stays and reduce medical costs.

[0048] The combined design of the enzyme storage chamber 3 and the enzyme flow channel 4 provides an airtight storage environment for the bio-enzymes, significantly extending their activity retention period and fundamentally solving the problem of easy inactivation upon exposure in existing technologies. Simultaneously, the enzyme storage chamber 3 continuously supplies fresh bio-enzymes to each enzyme flow channel 4. When enzymes in the flow channels become ineffective due to enzymatic reactions, they can be replenished immediately, ensuring long-term stability of pus enzymatic hydrolysis efficiency. Furthermore, the enzyme preparation in the enzyme storage chamber 3 can be replenished when depleted, further extending the patch's service life and reducing the frequency of dressing changes. In addition, the chitosan-modified enzyme preparation has a suitable viscosity, preventing uncontrolled leakage of the enzyme preparation from the enzyme contact window 41, while also enabling slow release through the enzyme contact window 41, ensuring sufficient contact between the enzyme and the pus.

[0049] Multiple enzyme channels 4 are arranged in a circular array around the enzyme storage chamber 3.

[0050] Through the array-like arrangement of enzyme channels 4 and the multi-window sustained-release design, the bio-enzymes can be evenly distributed throughout the entire wound coverage area, fully contacting the high-viscosity pus adsorbed by the hydrophilic layer 1. Through specific enzymatic hydrolysis, the high-viscosity macromolecules such as proteins, nucleic acids, and polysaccharides in the pus are directionally decomposed into water-soluble small molecule products such as small molecule peptides, monosaccharides, and amino acids, completely solving the problems of high viscosity, easy accumulation, and difficulty in drainage of pus. At the same time, the fluidity of the small molecule liquid after enzymatic hydrolysis is greatly improved, and it can be smoothly discharged through the hydrophobic layer 2, avoiding the pus from clogging the channels and spindle pores, realizing the self-cleaning function of the patch, and ensuring the long-term stability of the drainage effect.

[0051] In this embodiment, the enzyme flow channel 4 is connected to the bottom of the enzyme storage chamber 3. By connecting the enzyme flow channel 4 to the bottom of the enzyme storage chamber 3, gravity allows the viscous biological enzyme preparation fixed by chitosan in the enzyme storage chamber 3 to continuously and smoothly flow into each enzyme flow channel 4. This effectively avoids dead space for enzyme preparation residue in the enzyme storage chamber 3 and reduces ineffective waste of enzyme preparation. Even when the remaining amount of enzyme preparation in the enzyme storage chamber 3 is low, active enzyme can still be stably supplied to the enzyme flow channel 4, ensuring the continuous and stable enzymatic hydrolysis effect of pus. At the same time, it is compatible with the manual enzyme replenishment design of the enzyme storage chamber 3. The replenished enzyme preparation can quickly enter the enzyme flow channel 4 through the bottom connection port to take effect, further improving the stability and long-term effectiveness of the device.

[0052] The drainage patch 100 also includes multiple cell climbing balls 5 disposed within the hydrophilic layer 1, each of which has multiple climbing pits 51 recessed on its surface. By arranging cell climbing balls 5 with multiple climbing pits 51 recessed on their surface within the hydrophilic layer 1, a large number of three-dimensional, multi-dimensional cell anchoring and climbing sites can be provided for fibroblasts, epithelial cells, and granulation tissue related to wound repair. This overcomes the technical limitations of existing wound treatment technologies that do not have dedicated cell-priority growth structures, effectively guiding orderly cell colonization, proliferation, and crawling growth, significantly accelerating the regeneration of wound granulation tissue and the epithelialization process. At the same time, this structure does not hinder the capillary adsorption of wound pus and exudate by the hydrophilic layer 1, nor does it affect the full contact reaction between biological enzymes and body fluids within the enzyme channel 4. Under the premise of ensuring the stable realization of the patch's core functions of drainage and enzymatic hydrolysis, it can further improve wound healing efficiency and repair quality.

[0053] The cell climbing ball 5 is made of biodegradable material. The use of biodegradable material in the cell climbing ball 5 allows it to be compatible with the entire medical implant-grade biodegradable system of the drainage patch 100. Its degradation cycle can be precisely controlled through material ratios, closely matching the wound healing process. During the process of guiding cell colonization, proliferation, and creeping growth, it gradually degrades as the wound heals, eliminating the need for secondary surgery or frequent dressing changes due to structural retention. This completely avoids secondary tearing damage to newly formed granulation tissue caused by the removal or dressing changes of traditional non-degradable structures, significantly reducing patient suffering.

[0054] The hydrophilic layer 1, enzyme storage chamber 3, and enzyme flow channel 4 are all made of biodegradable materials. Specifically, all three are made of medical implant-grade biodegradable polymer materials. They can use a homologous biodegradable material system, which is fully compatible with the overall biodegradable design of the drainage patch 100. The degradation cycle of each component can be precisely controlled by material ratio and molding process parameters, achieving precise matching with the healing process of acute and chronic wounds.

[0055] The hydrophilic layer 1 uses medical-grade polycaprolactone (PCL) or polylactic-co-glycolic acid copolymer (PLGA) as the base biodegradable material and is formed by electrospinning. By adjusting the ratio of polymer monomers, the filament diameter and deposition density, the degradation rate and capillary fluid conduction performance of the hydrophilic layer 1 can be controlled simultaneously. Its degradation cycle can cover the complete healing cycle of common acute and chronic wounds in clinical practice. During the degradation process, it can maintain a stable pore structure, ensuring the continuous adsorption of wound pus and exudate and the uninterrupted one-way fluid conduction function.

[0056] The enzyme storage chamber 3 and enzyme channel 4 are made of medical-grade PCL or PLGA biodegradable material homologous to the hydrophilic layer 1, and are integrally formed by 3D printing. The two are directly connected to form a biomimetic tree-like enzyme supply network system. By adjusting the material wall thickness and polymer ratio, the degradation rate of the enzyme storage chamber 3 and enzyme channel 4 can be individually controlled, making its degradation cycle longer than that of the hydrophilic layer 1. This ensures that the sealing and enzyme storage performance of the enzyme storage chamber 3 and the fluid flow and sustained release performance of the enzyme channel 4 remain stable throughout the entire wound healing cycle, avoiding enzyme leakage and channel collapse and blockage caused by premature degradation. At the same time, this biodegradable material has good compatibility with chitosan-fixed specific biological enzyme preparations and will not react with the enzyme preparations to affect the enzyme's biological activity, thus maintaining the enzyme survival environment in the enzyme storage chamber 3 for a long time.

[0057] The hydrophilic layer 1, enzyme storage chamber 3, and enzyme flow channel 4 are all made of biodegradable materials. Together with the other components of the patch, they form a complete biodegradable system. The device can gradually degrade during the wound healing process, eliminating the need for secondary surgery to remove it and frequent dressing changes. This fundamentally solves the long-standing industry problem of existing negative pressure drainage sponge dressings causing secondary tearing damage to the wound during dressing changes due to granulation tissue growing into the material pores. It significantly reduces patient pain and reduces the burden of medical and nursing operations and the risk of cross-infection of the wound caused by frequent dressing changes.

[0058] The drainage patch 100 also includes an enzyme replenishment chamber 6, which is connected to the enzyme storage chamber 3. The enzyme replenishment chamber 6 includes a first part 61 disposed in the hydrophobic layer 2 and a second part 62 connected to the first part 61 and protruding outside the hydrophobic layer 2. The second part 62 is used to insert into the enzyme storage chamber 3, thereby achieving a seal of the enzyme storage chamber 3.

[0059] This embodiment features an enzyme replenishment chamber 6, which is connected to the enzyme storage chamber 3 and consists of a first part 61 embedded in the hydrophobic layer 2 and a second part 62 protruding into the enzyme storage chamber 3. The second part 62 forms a sealed connection with the enzyme storage chamber 3, enabling convenient and sterile replenishment of fresh, active biological enzymes without removing or disassembling the drainage patch 100. This completely solves the problem of needing to replace the entire patch after the enzyme preparation in the enzyme storage chamber 3 is depleted, significantly extending the single-use cycle of the patch, reducing the frequency of dressing changes, and avoiding secondary tearing damage to newly formed granulation tissue caused by frequent dressing changes. Simultaneously, the sealed enzyme replenishment channel prevents external air and contaminants from entering the enzyme storage chamber 3 and the wound area during enzyme replenishment, effectively preventing enzyme exposure and inactivation, maintaining the enzyme's catalytic activity for a long time, and flexibly adjusting the enzyme dosage and frequency according to the healing process and pus condition of different wounds. This significantly improves the device's clinical adaptability, ease of use, and stability of treatment effects.

[0060] The enzyme replenishment chamber 6 and the enzyme storage chamber 3 are connected by a snap-fit ​​mechanism. This snap-fit ​​connection between the enzyme replenishment chamber 6 and the enzyme storage chamber 3 enables a convenient and detachable sealed connection between the hydrophobic layer 2 carrying the enzyme replenishment chamber 6 and the hydrophilic layer 1 integrating the enzyme storage chamber 3 and enzyme flow channels 4. This allows for quick assembly and disassembly of the two layers without the need for specialized tools. While ensuring a stable seal at the connection point, preventing enzyme leakage and external contaminant intrusion, and without compromising the one-way moisture-wicking barrier of the hydrophobic layer 2 and the capillary absorption function of the hydrophilic layer 1, this design avoids the pulling and disturbance to the wound caused by frequent patch replacements, minimizing secondary tearing damage to newly formed granulation tissue.

[0061] The enzyme replenishment chamber 6 has an inverted frustum shape, with the cross-sectional area of ​​the side facing the enzyme storage chamber 3 being smaller than the cross-sectional area of ​​the side away from the enzyme storage chamber 3. Designing the enzyme replenishment chamber 6 as an inverted frustum shape, smaller on the side facing the enzyme storage chamber 3 and larger on the side away from the enzyme storage chamber 3, serves two purposes: First, the smaller end design allows for precise and smooth insertion into the enzyme storage chamber 3, improving the ease and fit of the connection and ensuring a tight seal. Second, the conical structure of the inverted frustum, combined with gravity, creates additional pressure on the enzyme preparation within the chamber. Compared to a straight cylindrical structure, this pressure promotes a smoother and more efficient flow of the enzyme preparation into the enzyme storage chamber 3, preventing enzyme stagnation and enabling rapid and sufficient replenishment. This continuously ensures enzyme activity and pus hydrolysis efficiency within the enzyme flow channel 4. Simultaneously, this pressure reduces the probability of air entering during enzyme replenishment, further lowering the risk of enzyme exposure and inactivation.

[0062] like Figures 7 to 9 As shown, the present invention also provides a method for manufacturing a drainage patch 100, comprising the following steps:

[0063] S1: Fabricate enzyme storage chamber 3, enzyme flow channel 4, and enzyme replenishment chamber 6, wherein enzyme contact window 41 is formed on enzyme flow channel 4; This step first independently prepares enzyme storage chamber 3 and enzyme flow channel 4, which can be precisely molded using 3D printing technology, ensuring the connection and sealing between enzyme storage chamber 3 and enzyme flow channel 4, and the dimensional accuracy of enzyme replenishment chamber 6. At the same time, independent fabrication allows for targeted control of parameters such as wall thickness and pore size of each component, adapting to the subsequent biodegradability and enzyme supply and replenishment function requirements, laying the structural foundation for subsequent spinning composite and component assembly, and improving the molding accuracy and functional stability of the overall device.

[0064] S2: A hydrophilic layer 1 is formed by spinning outside the enzyme storage chamber 3 and enzyme flow channel 4, and cell climbing balls 5 are added during the spinning process. This step uses electrospinning to integrally form the hydrophilic layer 1 on the outside of the enzyme storage chamber 3 and enzyme flow channel 4, so that the hydrophilic layer 1 is closely attached to the enzyme storage chamber 3 and enzyme flow channel 4, avoiding the gap between layers from affecting the capillary absorption and enzyme contact effect, and ensuring the rapid adsorption capacity of the hydrophilic layer 1 for wound pus. The simultaneous addition of cell climbing balls 5 during the spinning process allows the cell climbing balls 5 to be evenly dispersed inside the hydrophilic layer 1 without the need for additional fixing process. This ensures that the cell climbing balls 5 provide sufficient three-dimensional attachment sites for wound repair cells, without damaging the pore structure and capillary fluid conduction performance of the hydrophilic layer 1, thus achieving the structural integration of drainage function and cell healing function.

[0065] S3: A hydrophobic layer 2 is formed by electrospinning outside the enzyme replenishment chamber 6; This step involves electrospinning a hydrophobic layer 2 on the outside of the enzyme replenishment chamber 6, so that the hydrophobic layer 2 is precisely attached to the enzyme replenishment chamber 6. This utilizes the unidirectional moisture-guiding function of the hydrophobic layer 2 to form an anti-backflow barrier, ensuring the unidirectional drainage of the patch. At the same time, the hydrophobic layer 2 forms a protective coating on the enzyme replenishment chamber 6, preventing enzyme leakage and the intrusion of external contaminants during enzyme replenishment. Meanwhile, the hydrophobic layer 2 is only combined with the enzyme replenishment chamber 6 and does not interfere with the capillary absorption function of the hydrophilic layer 1 and the enzyme solution slow release function of the enzyme channel 4, thus realizing the functional zoning and structural adaptation of the hydrophilic and hydrophobic layers 2.

[0066] S4: Inject enzyme into enzyme replenishment chamber 6, and then connect enzyme replenishment chamber 6 to enzyme storage chamber 3 via a snap-fit ​​connection to achieve contact between hydrophilic layer 1 and hydrophobic layer 2. This step first injects enzyme preparation into enzyme replenishment chamber 6, and then achieves rapid sealing and docking of enzyme replenishment chamber 6 and enzyme storage chamber 3 through snap-fit ​​connection. At the same time, it completes the precise fitting and assembly of hydrophilic layer 1 and hydrophobic layer 2. The snap-fit ​​connection does not require professional tools, is convenient to assemble, and has strong sealing performance. It not only avoids leakage and exposure inactivation of enzyme preparation during assembly, but also ensures that hydrophilic layer 1 and hydrophobic layer 2 are tightly attached without damaging the one-way moisture-guiding channel of hydrophobic layer 2 and the capillary liquid absorption structure of hydrophilic layer 1. The integrated assembly allows enzyme preparation to flow quickly from enzyme replenishment chamber 6 into enzyme storage chamber 3 and be slowly released through enzyme flow channel 4, so that the drainage patch 100 can take effect quickly after assembly. At the same time, the detachable snap-fit ​​connection provides an operational basis for subsequent enzyme preparation replenishment and component replacement, improving the flexibility and long-term effectiveness of the device.

[0067] Step S3 specifically involves: providing a production fixture 20, which has a receiving groove, placing the second part 62 in the receiving groove, and then spinning a hydrophobic layer 2 on the outside of the first part 61. Step S3 involves setting up a production fixture 20 with a receiving groove and embedding the second part 62 of the enzyme replenishment chamber 6 within it. The hydrophobic layer 2 is spun only onto the first part 61. This precisely defines the forming area of ​​the hydrophobic layer 2, ensuring that the hydrophobic layer 2 only covers the first part 61 of the enzyme replenishment chamber 6 embedded within it. This prevents the spinning material from covering the protruding second part 62, ensuring the structural integrity and surface smoothness of the second part 62. This provides a structural foundation for the subsequent precise snap-fit ​​connection and smooth insertion with the enzyme storage chamber 3. Simultaneously, the positioning function of the fixture allows the enzyme replenishment chamber 6 to maintain a stable forming posture, ensuring the fit between the hydrophobic layer 2 and the first part 61. This prevents interlayer gaps during spinning from affecting the sealing and one-way moisture conduction effect, and also prevents the spinning material from overflowing into the enzyme replenishment chamber 6 and causing flow channel blockage. This ensures the smooth flow of subsequent enzyme preparations, significantly improving the forming accuracy of the hydrophobic layer 2 and the overall assembly compatibility of the device.

[0068] It should be noted that in step S2, the production tooling also needs to restrict the forming of the hydrophilic layer 1 to ensure the flatness of the side in contact with the hydrophobic layer 2. In step S3, the production tooling 20 restricts the forming of the hydrophobic layer 2 to ensure the flatness of the side in contact with the hydrophilic layer 1.

[0069] The drainage patch 100 and its preparation method of the present invention specifically address the core problems of poor portability and easy inactivation of biological enzymes in existing negative pressure drainage devices, making it difficult to maintain a sustained effect. By using a one-way moisture-guiding structure composed of a hydrophilic layer 1 and a hydrophobic layer 2, combined with the capillary force of the enzyme channel 4, spontaneous directional drainage without external equipment is achieved, completely eliminating the dependence on large negative pressure main units and significantly improving the portability of the device. At the same time, the sealed enzyme storage chamber 3 combined with the chitosan fixation system isolates the biological enzyme from air and keeps it active for a long time. Combined with the gravity enzyme supply design that connects the enzyme channel 4 and the enzyme storage chamber 3, the problem of easy enzyme inactivation and difficulty in maintaining a sustained effect is solved. Furthermore, the array arrangement and multi-window design of the enzyme channel 4 allow the enzyme to fully contact the pus and efficiently enzymatically decompose it, avoiding channel blockage and ensuring synergistic and long-term stable drainage and enzymatic decomposition functions.

[0070] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0071] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A drainage patch, characterized in that: The drainage patch includes a hydrophilic layer and a hydrophobic layer stacked together, an enzyme storage chamber, multiple enzyme channels communicating with the enzyme storage chamber, and an enzyme replenishment chamber. The enzyme storage chamber is a sealed structure. The enzyme channels are disposed within the hydrophilic layer. Each enzyme channel has multiple enzyme contact windows along its length. The enzyme storage chamber is configured to deliver its internal enzymes to the enzyme channels, so that the enzymes are exposed within the hydrophilic layer at the enzyme contact windows. The multiple enzyme channels are arranged in a circumferential array around the enzyme storage chamber. The enzyme channels are connected to the bottom of the enzyme storage chamber. The drainage patch also includes multiple cell climbing balls disposed within the hydrophilic layer. The surface of each cell climbing ball is recessed with multiple climbing pits. The drainage patch also includes an enzyme replenishment chamber communicating with the enzyme storage chamber. The enzyme replenishment chamber includes a first part disposed within the hydrophobic layer and a second part connected to the first part and protruding outside the hydrophobic layer. The second part is used to insert into the enzyme storage chamber.

2. The drainage patch according to claim 1, characterized in that: The cell climbing ball is made of biodegradable material.

3. The drainage patch according to any one of claims 1-2, characterized in that: The hydrophilic layer, enzyme storage chamber, and enzyme flow channel are all made of biodegradable materials.

4. The drainage patch according to claim 1, characterized in that: The enzyme replenishment chamber and the enzyme storage chamber are connected by a snap-fit ​​mechanism.

5. The drainage patch according to claim 1, characterized in that: The enzyme replenishment chamber has an inverted frustum-shaped structure, and the cross-sectional area of ​​the side facing the enzyme storage chamber is smaller than the cross-sectional area of ​​the side away from the enzyme storage chamber.

6. A method for manufacturing a drainage patch, for realizing the manufacturing of a drainage patch as described in any one of claims 1-5, characterized in that: Includes the following steps: S1: Construct an enzyme storage chamber, an enzyme flow channel, and an enzyme replenishment chamber, wherein an enzyme contact window is formed on the enzyme flow channel; S2: A hydrophilic layer is formed outside the enzyme storage chamber and enzyme flow channel during spinning, and cell climbing balls are added during the spinning process; S3: A hydrophobic layer is formed by spinning outside the enzyme replenishment chamber; S4: Inject enzyme into the enzyme replenishment chamber and snap the enzyme replenishment chamber to the enzyme storage chamber to achieve contact between the hydrophilic layer and the hydrophobic layer.

7. The method for manufacturing the drainage patch according to claim 6, characterized in that: Step S3 specifically involves: providing a production fixture with a receiving groove, placing the second part in the receiving groove, and then spinning a hydrophobic layer on the outside of the first part.

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