A ball bead support bridge-like anti-blocking drainage device for negative pressure sealing drainage

Abstract

The application discloses a ball bead supporting bridging type anti-blocking drainage device for negative pressure sealing drainage, which comprises an upper supporting layer and a lower drainage layer; the surface of the upper supporting layer is provided with uniformly distributed ball bead supports and drainage holes, the drainage holes are through holes, and the ball bead supports and the drainage holes are arranged alternately; the surface of the lower drainage layer is provided with uniformly distributed drainage through holes, and the drainage through holes correspond to the drainage holes. The application adopts a porous multi-supporting double-layer design, so that the structure does not collapse under the condition of effective negative pressure, the drainage is smooth, and the PVA material almost does not become dry and hard, the resilience and permeability are greatly improved, the sealing is easy, the flushing is easy, the drainage is easy, and the treatment effect and efficiency are remarkably improved.

Description

Technical Field

[0001] This invention belongs to the field of negative pressure closed drainage technology, specifically referring to a ball-bead support bridging anti-blockage drainage device for negative pressure closed drainage. Background Technology

[0002] In 1994, Professor Qiu Huade first applied the Vacuum Sealing Drainage (VSD) technique to general surgery, pioneering its application in Chinese general surgery.

[0003] Existing VSD (Vacuum-Assisted Surgery) technology typically includes a medical-grade hydrophilic or hydrophobic foam material (hereinafter collectively referred to as porous foam material), a sealing film, drainage tubing, a collection container, and a negative pressure source (including a medical suction machine, a hospital central negative pressure device, or a negative pressure drainage bottle). By applying continuous or intermittent negative pressure suction to the wound cavity, exudate, necrotic tissue, toxins, and pus can be drained from the wound cavity into a collection container, thus directly expelling these substances and preventing reabsorption of harmful substances. This reduces the number of bacteria in the wound and alleviates edema. Simultaneously, negative pressure suction increases blood flow to the wound and stimulates cell secretion of growth factors, effectively promoting angiogenesis and granulation tissue growth, accelerating tissue repair, and shortening wound healing time. Using this technology, patients can avoid dressing changes for up to 3 days, effectively preventing cross-infection, reducing the workload of medical staff, improving patient compliance, and lowering the mortality and disability rates associated with trauma.

[0004] The VSD (Vacuum-Assisted Surgery) technique currently consists of three consecutive actions: "sealing the wound," "applying negative pressure," and "drainage," achieving a coordinated and symbiotic complete treatment system. This coordinated and symbiotic interaction and mutual assistance is achieved in the following way—

[0005] Sealing is accomplished using foam materials. It is the most basic and necessary medical procedure in clinical surgery to transform an open wound into a closed wound. At the same time, once the wound is sealed, the planar infected wound is artificially transformed into a cavity, which provides a space for the subsequent negative pressure to work.

[0006] Applying negative pressure (vacuum) is achieved through external drainage tubes and a negative pressure source. The negative pressure here refers to the pressure within the wound cavity relative to the blood pressure in the capillaries within the wound tissue, created by the work done by the negative pressure source. The pressure within the wound cavity is much lower than the pressure in the blood vessels, hence the term "negative pressure." Because the pressure within the capillaries is much greater than the pressure outside the capillaries, the negative pressure on the wound surface directly affects the dilation and protrusion of the capillary walls within the wound. The dilation of the capillary walls... The protrusion increases the volume of the capillary lumen. This increase in volume and space has two main effects: First, the increase in blood flow and velocity by 5-12 times or more provides the wound with the necessary large number of histocytes, oxygen-rich red blood cells, and platelet clusters (PRP) rich in repair growth factors. Second, the continuous increase in the volume and space of the local wound causes the network of capillaries to expand, twist, and clump together towards the sidewalls of the vessels, thus forming a fresh, neat, and densely packed bed of granulation tissue, resembling rubies.

[0007] Connecting a drainage tube to a negative pressure source and a cavity in the wound involves using a drainage tube. Connecting a drainage tube serves two purposes: First, it provides a negative pressure source to the cavity in the wound, making the blood pressure in the capillaries within the wound tissue much higher than the pressure inside the cavity. This results in a 5-12 times increase in blood flow and velocity in the capillaries compared to other tissues outside the wound. Second, it continuously and rapidly cleans the wound of contaminants, necrotic tissue and debris, pus, and tissue exudate.

[0008] Therefore, vacuum, sealing, and drainage form a complementary and highly effective treatment system, which is VSD!

[0009] However, there are also significant drawbacks in its current clinical application. These mainly manifest as follows: hydrophilic porous foam materials tend to dry out and harden after 2-4 days of clinical application due to water loss, resulting in decreased material resilience, a significant reduction in effective drainage cavities, decreased permeability, and gradual blockage. Furthermore, under the influence of organic colloids such as pus, tissue fluid, exudate, and blood, the foam material pores often adhere together, leading to decreased elasticity and inability to rebound. All of these factors weaken the effectiveness and efficiency of the VSD device in wound repair and treatment.

[0010] In the prior art, some have proposed a structure in which an upper layer of straight column support columns and a porous panel form a multi-cavity groove network. However, this structure has the problem that the straight column support columns are too thin and long, and therefore the straight column support columns are prone to tilting and misaligning into the drainage holes after being stressed, leading to blockage. Others have proposed a three-layer honeycomb-shaped multi-cavity anti-blockage and anti-collapse wound drainage device, but this three-layer structure has too much space, which can easily lead to poor negative pressure conduction, large dead volume, and difficulty in suctioning medium and small amounts of exudate. Summary of the Invention

[0011] To address the shortcomings of existing technologies, this invention proposes a ball-bead support bridging anti-blockage drainage device for negative pressure closed drainage. It adopts a double-layer ball-bead support design, which ensures smooth drainage and prevents blockage. It also prevents the PVA material from drying out and hardening, and significantly improves its resilience and permeability. It is easy to seal and rinse, making drainage easy and significantly improving the treatment effect.

[0012] To achieve the above objectives, the present invention provides a ball-bead support bridging anti-blocking drainage device for negative pressure closed drainage, which is characterized by comprising an upper support layer and a lower drainage layer.

[0013] The upper support layer has a smooth upper surface and a lower surface with evenly distributed ball support and drainage holes. The lower surface area of ​​the ball support is smaller than the upper surface area, and the drainage holes are through holes that are arranged alternately with the ball support.

[0014] The lower drainage layer surface is provided with uniformly distributed drainage holes and support surfaces, and the support surfaces correspond to the ball support.

[0015] Furthermore, a connecting hole is provided on the support surface, and the lower surface of the ball support is embedded in the connecting hole and fixed to the lower drainage layer.

[0016] Furthermore, the ball support has a connecting groove in the middle, and a connector is provided on the support surface. The connector is embedded in the connecting groove and fixed in a limited position.

[0017] Furthermore, the lower surface of the ball support is an arc surface.

[0018] Furthermore, the upper surface of the upper support layer is connected to one or more suction cups, and the lower surface is connected to the lower drainage layer through ball support.

[0019] Furthermore, the upper support layer and the lower drainage layer are embedded in a negative pressure sealed drainage material.

[0020] Furthermore, PVA can be flocked onto the lower surface of the lower drainage layer using a spray-forming process, with the PVA layer thickness ranging from 0.2 mm to 0.8 mm.

[0021] Furthermore, the porosity of the upper support layer is 20% to 30%, and the porosity of the lower drainage layer is 25% to 35%.

[0022] Furthermore, the upper support layer and the lower drainage layer are made of soft and elastic hydrophobic material, and their shapes are cut and shaped according to the shape of the wound or cavity.

[0023] Furthermore, the upper support layer and the lower drainage layer are formed by a molding process, an injection molding process, or a compression molding process.

[0024] Furthermore, the negative pressure sealing and drainage material is polyvinyl alcohol foam, polyurethane foam, or polyvinyl alcohol polyurethane multilayer foam.

[0025] This invention further proposes a ball-bead support bridging anti-blockage drainage device for negative pressure closed drainage, characterized in that: it includes an upper support layer, the upper surface of which is smooth, and the lower surface is provided with uniformly distributed ball-bead supports and drainage holes. The lower surface area of ​​the ball-bead supports is smaller than the upper surface area, and the drainage holes are through holes, arranged alternately with the ball-bead supports; the upper support layer is embedded in the negative pressure closed drainage material, the upper surface of which is exposed, and the negative pressure closed drainage material directly contacts the wound or wound cavity.

[0026] Furthermore, the lower surface of the ball support is curved. Even further, the upper surface of the upper support layer is detachably connected to an external negative pressure device or flushing device and a drainage bag via one or more suction cups.

[0027] Furthermore, the upper support layer is made of a soft and elastic hydrophobic material, and its shape is cut and shaped according to the shape of the wound or cavity.

[0028] Furthermore, the upper support layer is formed by a copy molding process, injection molding process, or compression molding process.

[0029] Furthermore, the negative pressure sealing and drainage material is polyvinyl alcohol foam, polyurethane foam, or polyvinyl alcohol polyurethane multilayer foam.

[0030] Furthermore, the porosity of the upper support layer is 20% to 30%.

[0031] The foam material in existing VSD devices has a microscopic physical structure resembling a three-dimensional, fibrous network. When external negative pressure is applied, this network collapses, causing the organic colloids remaining within the cavity to adhere. This transforms the foam material's original three-dimensional network structure into a flat, non-rebounding structure, like a sheet of paper. This flat, non-expandable, paper-like material on the wound surface cannot provide the necessary negative pressure environment, rendering VSD's role in wound treatment limited to closure and coverage, without negative pressure drainage. To achieve a rebound effect and ensure unobstructed drainage space, straight columnar structures are sometimes used as supports for VSD wound materials. However, under high negative pressure, these structures often exert direct and rigid pressure on the capillary endothelial cells in the granulation tissue bed, causing endothelial cell compression necrosis and interruption of blood flow to the wound's capillary network, resulting in unsatisfactory treatment outcomes and efficiency for VSD wound treatment. Furthermore, the cylindrical support structure can cause the VSD wound material to harden and harden under high negative pressure during actual clinical operations, making it unable to adapt to the specific shape requirements of any wound terrain, such as twisted, stepped, rolled, or even folded wounds.

[0032] Compared with the prior art, the present invention has the following beneficial technical effects:

[0033] 1. The design of the upper ball support and the lower connecting hole or connector ensures that the upper and lower layers match and are firmly connected, preventing the support from tilting, skewing or misaligning during negative pressure suction; adaptable to the specific shape requirements of any wound surface terrain such as twisted, stepped, rolled or even folded.

[0034] 2. In actual use, the range between the maximum and minimum negative pressure required for clinical wound treatment varies considerably. The gradual and gentle deformation of the arc curvature of the supporting ball provides a space for VSD wound treatment that can adapt to drastic pressure changes while ensuring continuous and effective drainage and continuous rebound.

[0035] 3. When a straight columnar structure that provides support comes into contact with the wound, the contact area remains unchanged as pressure continues to increase, thus the pressure continues to increase. However, when a ball-bead support comes into contact with the wound, the contact area gradually increases as pressure continues to increase, thereby significantly reducing the pressure on the wound compared to a straight column support. This greatly reduces the possibility of blood flow obstruction within the wound tissue and compressive necrosis of tissue cells.

[0036] 3. The porous and multi-support design prevents structural collapse and blockage under effective negative pressure conditions;

[0037] 4. When used in combination with PVA materials, it provides pathways that do not dry out and collapse, and has a certain moisturizing effect. Therefore, it solves the problem that PVA materials are prone to drying out and hardening due to water loss, and that their elasticity and permeability gradually decrease, eventually leading to blockage.

[0038] 5. The upper support layer has a smooth and flat surface, making it easy to seal with medical sealing film and reducing the difficulty of operation for doctors.

[0039] 6. It can reduce the number of times wound materials need to be replaced clinically, extend the continuous use time of wounds, reduce the workload of doctors, reduce patient discomfort, and lower medical costs. Attached Figure Description

[0040] Figure 1 This is a side view of the structure of the present invention.

[0041] Figure 2 This is a schematic diagram of the upper support layer in Example 1.

[0042] Figure 3 This is a schematic diagram of the lower drainage layer in Example 1.

[0043] Figure 4 This is a schematic diagram of the structure in Example 1 where the upper support layer and the lower drainage layer are used in combination.

[0044] Figure 5 This is a schematic diagram of the structure in Embodiment 1 of the present invention, showing the combination of an upper support layer and a lower drainage layer.

[0045] Figure 6 This is a schematic diagram of the lower drainage layer in Example 2.

[0046] Figure 7 This is a side view structural diagram of Example 3.

[0047] Figure 8 This is a schematic diagram of the upper support layer in Example 3.

[0048] Figure 9 This is a schematic diagram of the lower drainage layer in Example 3.

[0049] Figure 10 Data from animal experiments using this device.

[0050] Figure 11 For clinical trial data using this device.

[0051] In the figure: upper support layer 1, ball support 1-1, drainage hole 1-2, connecting groove 1-3, lower drainage layer 2, drainage hole 2-1, support surface 2-2, connecting hole 2-3, connector 2-4, negative pressure sealing drainage material 10. Detailed Implementation

[0052] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0053] This invention proposes a ball-bead support bridging anti-blockage drainage device for negative pressure closed drainage, comprising an upper support layer 1 and a lower drainage layer 2; the upper surface of the upper support layer 1 is smooth, and the lower surface is provided with uniformly distributed ball-bead supports 1-1 and drainage holes 1-2, the lower surface area of ​​the ball-bead supports 1-1 is smaller than the upper surface area, and the drainage holes 1-2 are through holes, which are arranged alternately with the ball-bead supports 1-1; the surface of the lower drainage layer 2 is provided with uniformly distributed drainage holes 2-1 and support surfaces 2-2, and the support surfaces 2-2 correspond to the ball-bead supports 1-1.

[0054] Example 1

[0055] like Figures 1-3 As shown, this embodiment, as a preferred structure, is specifically a ball-bead support bridging anti-blockage drainage device for negative pressure closed drainage, including an upper support layer 1 and a lower drainage layer 2; the upper support layer 1 has a plurality of drainage holes 1-2 evenly distributed, and its upper surface is a smooth plane, which is convenient for sealing with a medical sealing film; its lower surface has a plurality of ball-bead supports 1-1 evenly distributed, and the radius of the circular bottom surface of the lower surface of the ball-bead support 1-1 opposite to the lower drainage layer 2 is smaller than the radius of the circular bottom surface of the upper surface, thereby forming a downwardly convex frustum; the drainage holes 1-2 are evenly distributed around the ball-bead supports 1-1.

[0056] The lower drainage layer 2 has multiple support surfaces 2-2 evenly distributed, and the support surfaces 2-2 correspond to the bottom surfaces of the ball bearing supports 1-1 in the upper support layer 1. Multiple drainage holes 2-1 are evenly distributed around the support surfaces 2-2. When the upper support layer 1 and the lower drainage layer 2 are combined, the ball bearing supports 1-1 correspond one-to-one with the support surfaces 2-1, which can not only provide support but also ensure unobstructed flow.

[0057] In one embodiment, the effective porosity of the upper support layer 1 is preferably 20%-30%, and the effective porosity of the lower drainage layer 2 is preferably 25%-35%; the height of the ball support 1-1 is preferably 2-4 mm.

[0058] Furthermore, PVA can be flocked onto the lower surface of the lower drainage layer using a spray-forming process, with the PVA layer thickness ranging from 0.2 mm to 0.8 mm.

[0059] The upper surface of the upper support layer 1 is a smooth plane, which can connect to various types of suction cups, and can connect to one or more suction cups. It is easy to seal with a medical sealing film. After sealing, the device can be detachably connected to the external negative pressure device and drainage bag via the suction cups. After connection, the external negative pressure device is activated, and the entire system begins negative pressure suction. In one embodiment, the ball-bead support bridging anti-blockage drainage device used for negative pressure closed drainage is made of a soft and elastic material, specifically medical silicone, rubber, or polyurethane. The anti-blockage drainage device for negative pressure closed drainage can be formed by a molding process, injection molding process, or compression molding process.

[0060] When in use, the shapes of the upper support layer 1 and the lower drainage layer 2 can be cut according to the shape and size of the wound or cavity.

[0061] The upper support layer 1 can be used alone or in combination with the lower drainage layer 2.

[0062] Furthermore, when the upper support layer 1 is used alone, it can be embedded on various negative pressure sealing drainage materials 10 (such as polyvinyl alcohol foam, polyurethane foam, polyvinyl alcohol polyurethane multilayer foam, etc.) to play a supporting, anti-blocking and drainage role.

[0063] Furthermore, when the upper support layer 1 and the lower drainage layer 2 are used in combination, the two layers can be used directly after being aligned and combined, or they can be embedded in various negative pressure sealing drainage materials 10 (such as polyvinyl alcohol foam, polyurethane foam, polyvinyl alcohol polyurethane multilayer foam, etc.) to play a supporting, anti-blocking and drainage role.

[0064] like Figure 4 and 5 As shown, when the ball-bead support bridging anti-blocking drainage device for negative pressure closed drainage is used in combination with the negative pressure closed drainage material 10, the ball-bead support bridging anti-blocking drainage device for negative pressure closed drainage can be embedded in the negative pressure closed drainage material 10 and the upper surface of the upper support layer 1 is exposed. In use, the negative pressure closed drainage material 10 is in direct contact with the wound or wound cavity, and the upper surface of the upper support layer 1 is connected to the suction cup.

[0065] During the use of this device, the wound is first sealed using a medical sealing film, thus sealing the wound. Once sealed, the planar infected wound is artificially transformed into a sac-like cavity, providing space for negative pressure to work. Then, the suction cup, external negative pressure device, and drainage bag apply negative pressure. Because the pressure inside the capillaries is much greater than the pressure outside, the negative pressure on the wound surface directly affects the expansion and protrusion of the capillary walls. Under the influence of negative pressure, the lower drainage layer 2 is deformed towards the negative pressure source, applying upward pressure to the ball support 1-1. During the upward deformation of the support surface 2-1... Applying compressive force to the lower surface of the ball bead support 1-1, since the radius of the circular bottom surface of the lower surface of the ball bead support 1-1 opposite to the lower drainage layer 2 is smaller than the radius of the circular bottom surface of the upper surface, under high negative pressure, the support surface 2-1 of the lower drainage layer 2 will contact the side of the ball bead support 1-1 after being compressed and deformed, increasing the contact area between the support surface 2-1 and the ball bead support 1-1, reducing the pressure on the contact surface, and greatly reducing the pressure on the capillary endothelial cells in the granulation tissue bed. Moreover, the ball bead support 1-1 is simultaneously subjected to force from the bottom and the side, preventing the ball bead support 1-1 from twisting and deforming. Next, the drainage tube connects the negative pressure source and the cavity on the wound surface to connect the drainage.

[0066] Furthermore, in a preferred embodiment, the lower surface of the ball-bead support 1-1 is a downwardly convex arc surface. Under negative pressure, the contact area between the support surface 2-1 of the lower drainage layer 2 and the ball-bead support 1-1 is larger, and the pressure on the ball-bead support 1-1 is smaller. After drainage is completed, the pressure inside the wound cavity decreases, the support surface 2-1 is no longer subjected to upward negative pressure, and rebounds downward, separating from the lower surface of the ball-bead support 1-1. The ball-bead support 1-1 maintains the relative space between the upper support layer 1 and the lower drainage layer 2, and the effective drainage gap is restored.

[0067] Example 2

[0068] like Figures 6-7 As shown, this embodiment proposes another preferred structure. The difference from embodiment 1 is that a connecting hole 2-3 is provided on the support surface 2-2 of the lower drainage layer 2. The lower surface of the ball support 1-1 of the upper support layer 1 is embedded in the connecting hole 2-3 and fixed with the lower drainage layer 2. This can provide support and ensure unobstructed flow.

[0069] Because the lower drainage layer 2 of this structure has a connecting hole 2-3 on its support surface 2-2, and the lower surface of the ball support 1-1 of the upper support layer 1 is embedded in the connecting hole 2-3, the overall thickness of this structure after the upper and lower layers are combined is 1 mm less than that of the structure in Example 1, that is, 4 mm thick. This design has the following three beneficial effects: 1. The limiting effect is more solid than that in Example 1; 2. It is suitable for flat wounds with small undulations or small curvatures; 3. The moisturizing effect is better.

[0070] Example 3

[0071] like Figures 8-9 As shown, this embodiment proposes another preferred structure. The difference from embodiment 1 is that the middle part of the ball support 1-1 of the upper support layer 1 is provided with a connecting groove 1-3, and the support surface 2-2 of the lower drainage layer 2 is provided with a connector 2-4. The connector 2-4 is embedded in the connecting groove 1-3 for limiting and fixing, which plays a supporting role and can also ensure smooth flow without blockage.

[0072] Since the upper support layer 1 has a connecting groove 1-3 in the middle of the ball support 1-1, and the lower drainage layer 2 has a connector 2-4 on the support surface 2-2, and the connector 2-4 is embedded in the connecting groove 1-3 for limiting and fixing, this structure has the following two beneficial effects: 1. The limiting effect is more solid than that of Example 2; 2. It is suitable for uneven or curved wound surfaces.

[0073] The three structures proposed in this invention, during negative pressure aspiration, cause the upper and lower layers to be drawn together under negative pressure. This creates conductive cavities around the ball-shaped support. In clinical application, when a negative pressure of 120 mmHg is applied to proximal tissues such as the abdomen, back, and the face (which have rich blood supply), the ball-shaped support remains stable and secure, preventing it from tipping over, thus forming multiple stable conductive cavities. Even in distal extremities with poor blood supply, when the aspiration negative pressure reaches 400 mmHg, these conductive cavities remain stable and secure. When the lower layer pores are blocked by blood clots, the multiple conductive cavities can continue to conduct negative pressure and remove the blood clots, thereby solving the blockage problem.

[0074] This invention significantly reduces the pressure area on granulation tissue on the wound surface, and is superior to PVA, PU, ​​and gauze. The reasons are as follows: 1. The beaded support structure of the upper support layer forms an LCP (limited contact plane), creating a bridge-like connection between the wound surface and the granulation bed, providing sufficient space for granulation tissue growth; 2. The LCP formed by the beaded support structure of this invention is far less than that of PVA, PU, ​​and gauze, thus more effectively reducing the pressure of wound materials on granulation tissue; 3. The pressure per unit area of ​​the LCP in the beaded support structure of this invention is far lower than that of the LCP in PVA, PU, ​​and gauze.

[0075] This invention can be used for both surface wounds and internal wound cavities. When used on surface wounds, since the skin is prone to dehydration and drying, using the PVA flocking structure on the lower surface of the drainage layer described in this invention, or the PVA wound material inlaid in this invention, will provide a more skin-friendly, moisturizing, and comfortable experience. When used on internal wound cavities, since the inner walls of deep cavities are always moist, and because this invention is soft and flexible, and the bead support structure avoids compressing granulation tissue to the greatest extent, directly using this invention will significantly improve the treatment effect compared to PVA materials, PU materials, and gauze.

[0076] This invention has excellent therapeutic effects on complex wound surfaces and is suitable for burns, blast injuries, lacerations, crush injuries, and flattening injuries of the perineum, anus, armpit, and submandibular region. The ball-bead support ensures that the smooth and gradual change of the arc curvature achieves the minimum absolute support height required by clinical needs.

[0077] The number, height, and curvature of the ball bearing supports determine the number and size of the conductive cavities, which in turn determine the anti-blocking effect. To ensure the stability of the ball bearing supports, we set the bottom diameter of the ball bearing supports to 3mm, the height to 3mm, and the hardness to 30 degrees. Then, we conducted animal experiments comparing three different numbers and curvatures of the structure 1 of this invention to verify the principle and effectiveness. The specific experimental methods and data are as follows:

[0078] Animal testing methods:

[0079] Clean-grade New Zealand rabbits, weighing 3.0-3.5 kg and male, were randomly divided into three groups (A, B, and C), with 30 rabbits in each group. Group A had 70 ball supports in the upper support layer with a curvature of 45°, Group B had 32 ball supports in the upper support layer with a curvature of 30°, and Group C had 139 ball supports in the upper support layer with a curvature of 60°.

[0080] 1. Construct an animal model.

[0081] 2. Combine the upper and lower layers of the structure 1 of the present invention together, and trim it to a suitable size according to the size of the wound. After thoroughly cleaning and stopping the bleeding, cover the wound with the trimmed structure 1 of the present invention. If necessary, perform appropriate suturing and fixation, and then seal the whole with a medical sealing film.

[0082] 3. Cut a small opening in the medical sealing film at an appropriate location and seal the suction cup over the opening.

[0083] 4. Connect the suction cup's drainage tube to the drainage bottle (a straight or three-way connector can be used to extend the drainage tube if necessary), connect the drainage bottle to the negative pressure suction machine, adjust to a suitable negative pressure and continue suctioning for 3 to 7 days. Starting from the second day, observe the wound healing process daily and record the data.

[0084] Animal test data such as Figure 10 As shown in the figure, number a represents the time to the outcome of the first-stage treatment, which refers to the time it takes for the wound and wound cavity to form a wound bed that can be repaired for a second stage of direct suturing, skin grafting, or tissue flap transfer after treatment with negative pressure wound therapy; number c represents the epithelialization rate. The epithelialization process includes three stages: migration, proliferation, and differentiation of keratinocytes, and is an important marker of the tissue repair process; the epithelialization rate is a significant indicator of the epithelial repair process.

[0085] According to animal test results, the design parameters should be: 70 spherical supports in the upper support layer and a curvature of 45°. The structure of this invention made according to these parameters can obtain a relatively larger conductive cavity, thereby improving the anti-blocking effect to a greater extent.

[0086] The optimized structure was fabricated according to these parameters and subjected to clinical trials, compared with ordinary negative pressure wound therapy materials. The experimental data are as follows: Figure 11 As shown:

[0087] Number A indicates the time of outcome of the first stage of treatment, which refers to the time when the wound and wound cavity are repaired by negative pressure wound therapy to form a wound bed that can be repaired in the second stage, such as direct suturing, skin grafting, or tissue flap transfer.

[0088] The designation C indicates the epithelialization rate. The epithelialization process includes three stages: migration, proliferation, and differentiation of keratinocytes, and is an important marker of the tissue repair process; the epithelialization rate is a significant indicator of the epithelial repair process.

[0089] The number D represents the blood perfusion volume of the wound surface and cavity, which refers to the amount of blood (ml) that can flow into the wall of the wound surface or cavity per square centimeter per minute from 100g of blood per minute. The greater the blood perfusion volume of the wound surface and cavity, the more active the formation of capillaries per unit area and the faster the growth rate of granulation tissue. PU = ml·100g-1·min-1.

[0090] The number F indicates the granulation tissue filling rate, which refers to the proportion of granulation tissue filling the wound surface and cavity. The higher the granulation tissue filling rate, the more the wound surface and cavity are filled with new granulation tissue, and the better the wound healing.

[0091] The number H indicates the number of days to dry, which refers to the time when the product becomes noticeably dry and hard.

[0092] The above experimental results show that the ball-bead support bridging anti-blockage drainage device for negative pressure closed drainage proposed in this invention has a structure with matching concave and convex parts, making the connection between the upper and lower layers stable and preventing tilting, skewing, or misalignment during negative pressure suction. When used alone, its double-layer, multi-porous, and multi-support design ensures smooth drainage without blockage. When used in combination with PVA material, it provides a pathway that does not dry out or collapse and has a certain moisturizing effect, preventing the PVA material from drying out and significantly improving its resilience and permeability. It is easy to seal, easy to rinse, and easy to drain, thus significantly improving the treatment effect and efficiency.

[0093] The specific embodiments of the present invention have been described in detail above, but they are merely examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions to the present invention are also within the scope of the present invention. Therefore, all equivalent transformations and modifications made without departing from the spirit and scope of the present invention should be covered within the scope of the present invention.

Claims

1. A ball-bead supported bridging anti-blocking drainage device for negative pressure closed drainage, characterized in that: It includes an upper support layer (1) and a lower drainage layer (2); The upper support layer (1) has a smooth upper surface and a lower surface with evenly distributed ball support (1-1) and drainage holes (1-2). The lower surface area of ​​the ball support (1-1) is smaller than the upper surface area. The drainage holes (1-2) are through holes and are arranged alternately with the ball support (1-1). The lower drainage layer (2) is provided with uniformly distributed drainage holes (2-1) and support surfaces (2-2) on its surface. The support surfaces (2-2) correspond to the ball support (1-1). The lower surface of the ball support (1-1) is an arc surface. The ball support (1-1) is provided with a connecting groove (1-3) in the middle. The support surface (2-2) is provided with a connector (2-4). The connector (2-4) is embedded in the connecting groove (1-3) and fixed in a limited position. The lower surface of the lower drainage layer (2) is a plane. The lower drainage layer (2) is squeezed and deformed towards the negative pressure source under negative pressure, and an upward squeezing force is applied to the ball support (1-1). During the upward deformation process, the support surface (2-2) applies a squeezing force to the lower surface of the ball support (1-1). The contact area between the support surface (2-2) of the lower drainage layer (2) and the ball support (1-1) is larger, and the pressure on the ball support (1-1) is smaller. After drainage is completed, the pressure inside the wound cavity decreases, the support surface (2-2) is no longer subjected to upward negative pressure, rebounds downward, and detaches from the lower surface of the ball support (1-1). The ball support (1-1) maintains the relative space between the upper support layer (1) and the lower drainage layer (2), and the effective drainage gap is restored. The porosity of the upper support layer (1) is 20%~30%, and the porosity of the lower drainage layer (2) is 25%~35%.

2. The ball-bead support bridging anti-blocking drainage device for negative pressure closed drainage according to claim 1, characterized in that: The upper surface of the upper support layer (1) is connected to one or more suction cups, and the lower surface is connected to the lower drainage layer (2) through ball support (1-1).

3. The ball-bead support bridging anti-blocking drainage device for negative pressure closed drainage according to claim 1, characterized in that: The upper support layer (1) and the lower drainage layer (2) are embedded in the negative pressure sealed drainage material (10).

4. The ball-bead support bridging anti-blocking drainage device for negative pressure closed drainage according to claim 1, characterized in that: The upper support layer (1) and the lower drainage layer (2) are made of soft and elastic hydrophobic material, and their shapes are cut and shaped according to the shape of the wound or cavity.

5. The ball-bead support bridging anti-blocking drainage device for negative pressure closed drainage according to claim 1, characterized in that: The upper support layer (1) and the lower drainage layer (2) are formed by a molding process, injection molding process or compression molding process.

6. The ball-bead support bridging anti-blocking drainage device for negative pressure closed drainage according to claim 1, characterized in that: The lower surface of the lower drainage layer (2) is flocked with a PVA layer using a spray-flocking process, and the PVA layer thickness is 0.2mm~0.8mm.

7. The ball-bead support bridging anti-blocking drainage device for negative pressure closed drainage according to claim 3, characterized in that: The negative pressure sealing drainage material (10) is polyvinyl alcohol foam or polyurethane foam.

8. The ball-bead support bridging anti-blocking drainage device for negative pressure closed drainage according to claim 7, characterized in that: The negative pressure sealing drainage material (10) is a multilayer polyvinyl alcohol polyurethane foam.

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