Drainage structure for continuous and uniform negative pressure conduction of full wound surface

Abstract

Disclosed is a drainage structure for continuous and uniform negative-pressure conduction on all wound profiles. The drainage structure is used in cooperation with a porous foam layer and configured for a negative pressure drainage operation, and comprises a structure body. The side of the structure body opposite to the porous foam layer is provided with a separator. The separator forms a cavity between the structure body and the porous foam layer. A through hole is formed in a position of the structure body opposite to the cavity. The through hole enables an upper space and a lower space of the structure body to communicate with each other. The present invention adopts a single-layer structure to enhance the negative pressure conduction effect, such that, when the drainage structure is applied to an uneven wound surface or a cavity gap, upper and lower layer misalignment cannot be generated in the negative pressure condition. When used in combination with a PVA material, the drainage structure provides a passage that will not dehydrate, stiffen, or collapse for the PVA material, achieves a certain moisturizing effect, and prevents the PVA material from dehydration, stiffening, or rebound resilience and permeation reduction, thus solving the blockage problems.

Description

Drainage structure for continuous and uniform negative pressure transmission across the entire wound surface Technical Field

[0001] The present invention belongs to the technical field of negative pressure sealed drainage, and specifically refers to a drainage structure that conducts negative pressure continuously and evenly over the entire wound surface. Background Art

[0002] Existing VSD technology, based on its basic configuration, consists of a medical hydrophilic foam material or a medical hydrophobic foam material (hereinafter collectively referred to as porous foam material), a sealing film, a drainage tube, a collection container, and a negative pressure source (including a medical suction machine, a hospital-based central negative pressure device, or a negative pressure drainage bottle). By applying continuous or intermittent negative pressure suction to the wound cavity, harmful substances such as exudate, necrotic tissue, toxins, and pus within the wound cavity can be drained into a collection container and then directly excreted from the body. This prevents reabsorption of harmful substances by the liver and kidneys, reduces the bacterial count in the wound, alleviates edema, and prevents the occurrence of multiple organ failure (MOF) and respiratory distress syndrome (ARDS). Furthermore, negative pressure suction increases blood flow to the wound and stimulates cell secretion of growth factors, effectively promoting the growth of new blood vessels and granulation tissue, promoting tissue repair, and shortening wound healing time. The use of this technology can effectively avoid cross infection, reduce the workload of medical staff, improve the healing rate of patients' wounds and cavities, and reduce the mortality and disability rates of trauma.

[0003] VSD technology currently consists of three consecutive actions: "sealing the wound (Sealing)" + "applying negative pressure (Vacuum)" + "connecting drainage (Drainage)" to achieve a complete treatment system of coordinated symbiosis. The process of coordinated symbiosis, interaction and mutual assistance is achieved in this way:

[0004] Sealing is done with foam materials. It is the most basic and necessary medical process in clinical surgery to convert an open wound into a closed wound. At the same time, after the wound is sealed, the flat infected wound is artificially transformed into a cavity, and the cavity provides a space for the next step of negative pressure to work.

[0005] Negative pressure is achieved by external drainage lines and negative pressure sources. The negative pressure here and now refers to the pressure in the cavity space on the wound surface compared with the blood pressure in the capillaries in the wound tissue due to the work done by the negative pressure source. The pressure in the cavity space on the wound surface is much smaller than the pressure in the blood vessels, so it is called negative pressure. Also, because the pressure in the capillaries is much greater than the pressure outside the capillaries, the negative pressure on the wound surface will directly affect the expansion and bulging of the capillary walls in the wound surface. The expansion and bulging of the capillary walls cause the capillaries to The spatial volume of the capillary cavity increases; the increase in space and volume has two major effects: First, the increase of 5-12 times or more in blood flow and blood flow velocity brings a large number of tissue stem cells, oxygen-rich red blood cells and platelet groups (PRP) rich in repair growth factors and various amino acid components for the production of tissue proteins necessary for wound repair... Second, the continuous increase in the space and volume of the local wound will cause the network-like capillaries to expand, twist and clump toward the side walls of the blood vessels, thus forming a fresh, neat and dense ruby-like granular granulation tissue bed.

[0006] Drainage is the process of connecting a negative pressure source to the cavity on the wound surface through a drainage tube. Drainage: 1. It provides a negative pressure source for the cavity on the wound surface, making the blood pressure in the capillaries in the wound tissue much greater than the pressure in the cavity, so that the blood flow and blood flow velocity in the capillaries increase by 5-12 times compared with other tissues outside the wound surface; 2. It continuously and quickly cleans the pollutants, necrotic tissue and necrotic tissue debris, pus, tissue exudate, etc. on the wound surface.

[0007] Therefore, vacuum, sealing, and drainage form a complementary and efficient treatment system. Vacuum, sealing, and drainage are VSD!

[0008] However, there are still some major defects in clinical application, including at least the following problems:

[0009] (1) Porous foam materials tend to dry out and harden due to water loss after 2-4 days of clinical application, resulting in decreased material resilience, a significant reduction in effective drainage cavities, decreased permeability, and gradual blockage. In addition, under the action of organic colloids such as pus, tissue fluid, exudate, and blood, the pores of the foam material often become adhered, the foam elasticity decreases, and the foam material covering the entire wound surface is actually unable to rebound;

[0010] (2) When a double-layer drainage device is applied to an uneven wound cavity, under negative pressure, the curvatures of the upper and lower structures are different when bent, which will generate shear forces on the endothelial cells on the uneven wound surface, thereby damaging and puncturing the granulation tissue of the endothelial cells, causing the wound tissue bed to lose its repair vitality.

[0011] (3) The difference in curvature between the bottom of the double-layer drainage device and the PVA causes the PVA to fall off, resulting in the displacement of multiple layers up and down, making the overall negative pressure drainage system on the wound loose and even leaking and collapsing. Summary of the Invention

[0012] In response to the shortcomings of the existing technology, the present invention proposes a drainage structure that conducts negative pressure continuously and evenly across the entire wound surface. The single-layer structure enhances the negative pressure conduction effect and the amount of wound drainage. The resistance to negative pressure conduction is greatly reduced. The negative pressure effect is continuously and evenly distributed across the entire wound surface. The hydrophilic PVA material provides continuous wound moisturizing in the elastic space that can be freely retracted and expanded. The simple single-layer support and drainage structure also avoids deformation and displacement of other multi-layer designs.

[0013] To achieve the above-mentioned purpose, the present invention designs a structure for continuous and uniform negative pressure conduction and drainage of the entire wound surface, which is used in conjunction with a porous foam layer for negative pressure drainage operations. The special feature of the structure is that it includes a structural body; a separator is provided on the side opposite to the porous foam layer, and the separator forms a cavity between the structural body and the porous foam layer. A through hole is provided at the position opposite to the cavity of the structural body, and the through hole connects the upper space of the structural body with the lower space.

[0014] Furthermore, one end of the separator is fixed to the structural body, while the other end is a top end. The volume of the separator gradually decreases from the fixed end to the top end, thereby forming a gradually expanding surface along the surface of the separator from the fixed end to the top end. Under negative pressure, the gradually expanding surface gradually increases the contact area between the porous foam layer and the separator, thereby gradually reducing the pressure on the separator. As a result, the pressure exerted by the separator on the wound surface gradually and evenly decreases, reducing the pressure on the granulation tissue surface to the minimum physiological level.

[0015] Furthermore, the fixed end is a circle or a regular polygon, and the top end is a vertex or an end face. The circular or regular polygonal fixed end is connected to the bottom surface of the structural body, and the top end is connected to the porous foam layer.

[0016] Furthermore, the ratio of the spacing d2 between adjacent separators on the structural body to the width d1 of the separator bottom surface is 0.2 to 3. If the spacing between adjacent separators is too large, the separators will not be able to generate rebound force, and the porous foam layer and the structural body may adhere to each other due to residual colloidal substances in the drainage fluid, making them impossible to separate. If the spacing is too small, various colloidal drainage substances are likely to accumulate, preventing the drainage from being discharged from the wound surface in a timely manner.

[0017] Furthermore, the separator is a body of revolution, and the generatrix of the body of revolution is a straight generatrix or a curved generatrix. Thus, the structural distribution of the body of revolution makes the outer surface of the separator smooth and the force evenly distributed.

[0018] Furthermore, the axial section of the separator is in the shape of a triangle, a trapezoid, a circle, a semicircle, an ellipse, a rectangle, a parallelogram, or a combination of two of them.

[0019] Furthermore, the separator is a columnar structure with a plurality of flange structures extending axially outward.

[0020] Furthermore, the front end of the flange structure is a curved surface or a conical surface.

[0021] Furthermore, the outer surface of the separator is provided with evenly or unevenly distributed protrusions for better combining with the PVA raw material during the flocking process.

[0022] Furthermore, the surface of the structural body close to the wound surface is connected to the porous foam layer, and the surface away from the wound surface is connected to one or more suction cups.

[0023] Furthermore, the porous foam layer is made of one or more materials selected from polyvinyl alcohol resin PVA, modified polyvinyl alcohol resin PVA, polyurethane elastomer PU or modified polyurethane elastomer PU.

[0024] Furthermore, a sealing film is provided on the surface of the structural body away from the wound surface, and a drainage hole is provided on the sealing film. The skirt of the suction cup is in contact with the semipermeable membrane, and the cavity in the middle of the suction cup is opposite to the drainage hole.

[0025] Furthermore, the surface of the structural body on the side away from the wound surface is a rough plane, which is used to generate damping for the sealing membrane to prevent displacement.

[0026] Furthermore, the structural body and the porous foam layer are fixedly connected by suturing or gluing, and the structural body and the porous foam layer can be cut and spliced ​​as needed according to the size of the wound surface.

[0027] Furthermore, the fixing points between the structural body and the porous foam layer are evenly distributed to ensure effective fixation within the cutting area when cutting for use.

[0028] Furthermore, the structural body is flocked on the surface of the porous foam layer after being heat-dried through a coating process.

[0029] Furthermore, there are a plurality of separators, which are evenly arranged on the surface of the structural body close to the wound surface.

[0030] Furthermore, the bottom diameter of the separator is no more than 10 mm, and the height is no more than 6 mm.

[0031] Furthermore, the porosity of the structural body is 15% to 70%.

[0032] Furthermore, the structural body and the separator are made of thermosetting elastomer, rubber or thermoplastic elastomer.

[0033] Furthermore, the structural body is formed by a composite molding process, an injection molding process or a compression molding process.

[0034] Furthermore, the hardness of the structural body is in the range of 5 to 35 degrees, and the hardness of the separator is in the range of 5 to 40 degrees. The hardness of the separator can be slightly greater than that of the structural body to give the structural body appropriate resilience.

[0035] The structure for continuous and uniform negative pressure conduction and drainage of the entire wound surface proposed in the present invention is used in conjunction with a porous foam layer in negative pressure drainage treatment. The separator arranged on the lower surface of the structural body forms a cavity between the structural body and the porous foam layer below, thereby forming an effective conduction channel on the surface of the porous foam layer, while reducing the pressure between the porous foam layer and the wound surface, and greatly reducing the pressure on the capillary endothelial cells on the granulation tissue bed; after drainage is completed, the separator helps the structural body to rebound upward, so that the cavity volume is gradually restored, thereby maintaining a relatively stable space between the structural body and the porous foam layer, and the effective drainage gap is restored.

[0036] Compared with the prior art, the present invention has the following beneficial technical effects:

[0037] 1. The design of the separator prevents the pillar from tilting, skewing or dislocating during negative pressure suction; it can adapt to the specific requirements of any wound surface topography, such as twisting, stepping, curling or even bending;

[0038] 2. In actual use, the range between the maximum and minimum negative pressures required for clinical wound treatment varies greatly. The gradual and gentle deformation of the arc curvature of the separator provides a space for wound negative pressure drainage treatment that can adapt to drastic pressure changes while ensuring continuous and effective drainage and continuous rebound.

[0039] 3. The spacing between the separators should be designed within a reasonable range to prevent the porous foam layer and the structural body from being adhered to each other by colloid substances and unable to be separated due to excessive spacing, and to prevent the accumulation of various colloid-like drainage substances due to excessive spacing, which will prevent the drainage substances from being discharged out of the wound in time.

[0040] 4. During the negative pressure drainage operation, as the pressure continues to increase, the pressure on the wound surface will continue to increase; while when the separator contacts the wound surface, as the pressure continues to increase, the contact area will gradually increase, so that the pressure on the wound surface is significantly reduced compared to that of a straight column support, and the possibility of blood flow blockage in the wound tissue and compressive necrosis of tissue cells is greatly reduced;

[0041] 5. When the drainage structure designed by the present invention is clinically applied to uneven wound surfaces and cavity gaps, under negative pressure conditions, no upper and lower layer displacement or shearing will occur;

[0042] 6. When used in combination with PVA porous foam materials, it provides a channel that will not dry out and collapse, and has a certain moisturizing effect, thereby solving the problem that PVA porous foam materials are prone to drying out and hardening due to water loss, the resilience and permeability of the foam materials gradually decrease, and the drainage channel blockage that gradually occurs as a result;

[0043] 7. It can reduce the number of times wound surface and cavity materials are replaced in clinical practice, reduce the possibility of wound surface being contaminated by air, prolong the continuous use time of negative pressure drainage materials in the wound surface and cavity, reduce the workload of medical staff, reduce the pain of patients in removing and changing dressings, greatly reduce medical costs, and greatly improve diagnosis and treatment efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] FIG1 is a schematic diagram of the main structure of Example 1 of the present invention;

[0045] FIG2 is a bottom view of the structure of Example 1 of the present invention;

[0046] FIG3 is a schematic diagram of a top view of the structure of Example 1 of the present invention;

[0047] FIG4 is a schematic diagram of the main structure of a single separator having a trapezoidal axial section in Example 2 of the present invention;

[0048] FIG5 is a schematic diagram of the three-dimensional structure of a single separator having a triangular axial section in Example 2 of the present invention;

[0049] FIG6 is a schematic diagram of the main structure of a single separator having a truncated cone-shaped axial section in Example 2 of the present invention;

[0050] FIG7 is a schematic diagram of the three-dimensional structure of a single separator having a truncated cone-shaped axial section in Example 2 of the present invention;

[0051] FIG8 is a schematic diagram of the main structure of a single separator having an elliptical axial section in Example 2 of the present invention;

[0052] FIG9 is a schematic diagram of the three-dimensional structure of a single separator having an elliptical axial section in Example 2 of the present invention;

[0053] FIG10 is a schematic diagram of the main structure of a single separator having an outer flange structure in Example 3 of the present invention;

[0054] FIG11 is a schematic diagram of the three-dimensional structure of a single separator having an outer flange structure in Example 3 of the present invention;

[0055] FIG12 is a schematic diagram of the front view of the drainage structure for continuous and uniform negative pressure transmission across the entire wound surface according to Example 4 of the present invention;

[0056] FIG13 is a schematic diagram of the front view of the drainage structure for continuous and uniform negative pressure transmission across the entire wound surface according to Example 5 of the present invention;

[0057] FIG14 is a schematic diagram of the front view of the drainage structure for continuous and uniform negative pressure transmission across the entire wound surface according to Example 6 of the present invention;

[0058] FIG15 is a schematic diagram of the structure of the drainage structure for continuous and uniform negative pressure conduction across the entire wound surface according to Example 6 of the present invention;

[0059] FIG16 is a schematic diagram of the front view of the drainage structure for continuous and uniform negative pressure conduction across the entire wound surface according to Example 7 of the present invention.

[0060] In the figure: structural body 1, porous foam layer 2, separator 3, fixed end 3-1, top end 3-2, cavity 4, through hole 5, sealing membrane 6, suction cup 7, drainage hole 8. Implementation Method

[0061] The present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0062] Example 1

[0063] As shown in Figures 1 to 3, this embodiment proposes a drainage structure for continuous and uniform negative pressure conduction across the entire wound surface, including a structural body 1. The lower surface of the structural body 1 is provided with evenly distributed separators 3, and the separators 3 form a cavity 4 between the structural body 1 and the porous foam layer 2 below; the structural body 1 is provided with a through hole 5 at a position opposite to the cavity 4, and the through hole 5 connects the upper space of the structural body 1 with the lower space.

[0064] The structural body 1 and the porous foam layer 2 are both flexible structures. The structural body 1 can be a sheet structure, or a roughly sheet structure with irregular deformations such as depressions, protrusions, twists, folds, etc. on the basis of the structure.

[0065] When implementing negative pressure drainage using the present invention, the wound surface is first sealed with a medical sealing film (sealing). This seal transforms the flat surface of the infected wound into a sac, creating a space for the negative pressure to work. Next, an external negative pressure device applies negative pressure to the sac. The strong negative pressure within the sac actually causes the pressure inside the capillaries to be much greater than the pressure outside the capillaries. Consequently, the negative pressure on the wound surface directly affects the expansion and bulging of the capillary walls within the wound. Under the negative pressure, the structural body 1 is squeezed and deformed toward the source of the negative pressure. The underlying porous foam layer 2 exerts an upward compressive force on the separator 3, reducing the pressure on the contact surface between the porous foam layer 2 and the separator 3. This significantly reduces the pressure on the capillary endothelial cells in the granulation tissue bed. Furthermore, the separator 3 is simultaneously stressed from the bottom and sides, preventing it from twisting and deforming. Next, a drainage tube connects the negative pressure source to the sac on the wound surface, enabling drainage. Drainage fluid is conducted from the porous foam layer 2 to the cavity 4 and then drained out through the through-holes 5. As the negative pressure increases, the volume of the cavity 4 is continuously compressed, and the contact area between the porous foam layer 2 and the separator 3 gradually increases, reducing the pressure on the separator 3 and, consequently, the pressure on the wound. After drainage is completed, the pressure within the wound cavity drops, and the porous foam layer 2, no longer subject to negative pressure, begins to rebound, gradually moving away from the lower surface of the separator 3. This gradually restores the volume of the cavity 4, and the separator 3 maintains the relative space between the structural body 1 and the porous foam layer 2, thus restoring the effective drainage gap.

[0066] Example 2

[0067] The shape, structure and arrangement of the separator 3 can be designed in various ways and can be adjusted adaptively according to actual needs.

[0068] As one embodiment of the present invention, the separator 3 is a body of revolution, and the generatrix of the body of revolution is a straight generatrix. The axial cross-section of the separator 3 is one or a combination of a triangle, a trapezoid, a circle, a semicircle, a truncated cone, an ellipse, a rectangle, or a parallelogram. A structure in which the axial cross-section of the separator 3 is a trapezoid is shown in FIG4 , a structure in which the axial cross-section is a triangle is shown in FIG5 , a structure in which the axial cross-section is a truncated cone is shown in FIG6 and FIG7 , and a structure in which the axial cross-section is an ellipse is shown in FIG8 and FIG9 .

[0069] One end of the separator 3 is the fixed end 3-1 fixed to the bottom of the structural body 1, and the other end is the top 3-2; the volume of the separator 3 gradually shrinks from the fixed end 3-1 to the top 3-2, so that the cavity 4 forms a gradually expanding surface along the surface of the separator 3 from the fixed end 3-1 to the top 3-2.

[0070] The structural body 1 and separator 3 are made of thermosetting elastomer, rubber, or thermoplastic elastomer. This structure can be formed using a composite molding process, injection molding, or compression molding. The effective porosity of the structural body 1 is preferably 15%-70%. The bottom diameter of the separator 3 is no greater than 10 mm, and the height is no greater than 6 mm. The hardness of the structural body 1 ranges from 5 to 35 degrees, and the hardness of the separator 3 ranges from 5 to 40 degrees.

[0071] During use, the structural body 1 is placed on the porous foam layer 2, or the two are fixedly connected by suturing or gluing. The structural body 1 is a sheet-like structure, and its shape can be cut and spliced ​​according to the shape and size of the wound surface or wound cavity. The fixing points between the structural body 1 and the porous foam layer 2 are evenly distributed, ensuring effective fixation within the cutting area during cutting and use. The top 3-2 of the separator 3 contacts the porous foam layer 2, so that the downwardly convex curved surface of the separator 3's lower surface forms an upwardly tapering cavity 4 on the upper surface of the porous foam layer 2.

[0072] Under the action of negative pressure, the drainage fluid is conducted from the porous foam layer 2 to the cavity 4 and drained out through the through hole 5. Since the area of ​​the top 3-2 of the separator 3 is smaller than the bottom area of ​​the fixed end 3-1, under the action of high negative pressure, the lower porous foam layer 2 will contact the side of the separator 3 after being squeezed and deformed. The arc-shaped side increases the contact area between the porous foam layer 2 and the separator 3, thereby reducing the pressure on the separator 3 and reducing the pressure on the wound.

[0073] Example 3

[0074] The difference between this embodiment and embodiment 1 is that the separator 3 is a columnar body of revolution, and the generatrix of the body of revolution is a curved generatrix. Several flange structures extend axially outward from the separator 3, as shown in Figures 10 and 11. The front end of the flange structure is a curved surface or a conical surface.

[0075] When the separator 3 in this embodiment is used, the flange structure increases the surface area of ​​the separator 3. During the negative pressure drainage operation, the pressure on the separator 3 will be further reduced due to the larger surface area, so that the drainage structure has less pressure on the wound surface, reducing the patient's pain.

[0076] Furthermore, the separator 3 with a tooth-shaped flange structure better maintains the cavity 4 between the structural body 1 and the porous foam layer 2, so that the structural body 1 and the porous foam layer 2 can rebound immediately after the negative pressure drainage is completed. At the same time, the separator 3 made of elastic material can provide a higher elastic coefficient, and continue to provide rebound force like a spring structure during rebound, thereby maintaining the effect of negative pressure conduction.

[0077] Example 4

[0078] The difference between this embodiment and embodiment 1 is that, as shown in FIG12 , the ratio of the distance d2 between adjacent separators 3 on the structural body 1 to the width d1 of the bottom surface of the separator 3 is 0.2-3.

[0079] In this embodiment, 30 samples each with a large d2 / d1 ratio, a d2 / d1 ratio of 0.2 to 3, and a small d2 / d1 ratio were selected for performance testing. The samples were continuously pumped for 7 days under a negative pressure of 85 mmHg without flushing. The test results are shown in Table 1:

[0080] Table 1 Comparison of experimental effects of d2 / d1 ratio changes

[0081]

[0082] Experimental results confirm that when the ratio of d2 / d1 is too large, the cavity 4 formed by the gradually expanding surface of adjacent separators 3 is too large. When the negative pressure increases, the cavity 4 between the porous foam layer 2 and the structural body 1 that lacks the support of the separator 3 gradually disappears. The porous foam layer 2 is in direct contact with the structural body 1, and the negative pressure on the wound will act on the wound without being reduced by the separator 3; after the drainage is completed, due to the lack of the rebound force generated by the separator 3, the porous foam layer 2 and the structural body 1 may be unable to separate due to adhesion caused by the residual colloidal substance in the drainage fluid, causing the volume of the cavity 4 to shrink, so that the structural body 1 begins to dry and harden locally from the upper surface, gradually causing large-scale drying and hardening and comprehensive blockage.

[0083] When the ratio of d2 / d1 is within a reasonable range of 0.2 to 3, the structural body 1 can remain moist and soft after continuous suction for 3 to 5 days, the drainage efficiency is not hindered, there is no blockage, and the drainage effect is good.

[0084] When the ratio d2 / d1 is too small, the cavity 4 formed by the gradually expanding surfaces of adjacent separators 3 is small, which easily causes drainage fluid to accumulate and cannot be discharged through the through hole 5 in time. In addition, the colloid in the drainage fluid easily causes the through hole to be blocked.

[0085] Example 5

[0086] The difference between this embodiment and embodiment 1 is that the upper surface of the structural body 1 is a non-smooth rough surface, as shown in FIG13 .

[0087] The upper surface of the structural body 1 is sealed by a sealing film 6. A damping is formed between the structural body 1 with a rough surface and the sealing film 6 to prevent the structural body 1 from being displaced relative to the sealing film 6, thereby causing the risk of loosening or falling off.

[0088] Example 6

[0089] In this embodiment, the surface of the structural body 1 near the wound surface is connected to the porous foam layer 2, and the surface away from the wound surface is connected to one or more suction cups 7, facilitating sealing with a medical sealing membrane 6, as shown in Figure 14. The sealing membrane 6 is provided with drainage holes 8. The skirt of the suction cup 7 is in contact with the semipermeable membrane, and the central cavity of the suction cup 7 is located opposite the drainage holes 8, as shown in Figure 15.

[0090] After sealing, the structure can be detachably connected to the external negative pressure device and the drainage bag through the suction cup 7. After the connection is completed, the external negative pressure device is started, and the entire system begins to perform negative pressure suction.

[0091] Example 7

[0092] As shown in FIG16 , this embodiment proposes another preferred structure, which differs from embodiment 1 in that the outer surface of the separator 3 is provided with protrusions that are densely regularly or irregularly distributed, and the front section of the protrusion can be designed as a spike or a cone, or a chamfered protrusion.

[0093] When the structural body 1 adopts a coating process and heat-drying to flock PVA on the lower surface of the structural body 1, the gas mixed in the foam material liquid expands in volume due to the heat during the heating process, forming bubbles that evaporate and rise. The bubbles form channels and cavities in the rising process, and the small bubbles on the top layer gradually break. When the small bubbles at the crack opening meet the bulge on the outer surface of the separator 3, the small bubbles solidify on the bulge surface at the gap between the bulge and the small bubbles filled, and are firmly bonded to the outer surface of the separator 3.

[0094] The seven structures proposed by the present invention, when performing negative pressure suction, form conductive cavities around the separators under the influence of negative pressure. In clinical practice, even in proximal tissues such as the abdomen, back, and face with a rich blood supply, the separators 3 remain stable and firm, thus forming multiple stable conductive cavities. For distal extremities with poor blood supply, the conductive cavities remain stable and firm even when suction pressure reaches 400 mmHg. Even if the lower-layer pores become clogged with blood clots or pus-like colloids, the multiple conductive cavities continue to transmit negative pressure and aspirate the clots or pus-like colloids, thus resolving the blockage issue.

[0095] The present invention significantly reduces the area of ​​pressure on the granulation tissue on the wound surface and is superior to PVA materials, PU materials, and gauze. The reasons are: 1. The separator structure forms an LCP (limited contact plane), which forms a bridge-like connection network between the wound surface and the granulation tissue bed, providing sufficient space for granulation tissue growth; 2. The LCP formed by the separator structure of the present invention is far less than that of PVA materials, PU materials, and gauze, so it more effectively reduces the pressure of the wound material on the granulation tissue; 3. The pressure per unit area of ​​the LCP of the separator structure of the present invention is much lower than the pressure of the LCP of PVA materials, PU materials, and gauze.

[0096] The present invention can be used for both surface wounds and internal wound cavities. When used for surface wounds, since the body surface is prone to dehydration and drying, designing the lower surface of the present invention as a PVA flocking structure or using the present invention's chimeric PVA wound material will make the material more compatible with the wound tissue and provide an optimal moist healing environment for the healthy growth of granulation tissue endothelial cells; when used for internal wound cavities, since the inner wall of the deep cavity is always moist and the present invention is soft and flexible, the separator structure avoids compression of the granulation tissue to the greatest extent, so directly using the present invention will significantly improve the wound treatment effect compared to simply using PVA material, PU material, gauze material, etc.

[0097] The present invention has an excellent therapeutic effect on surface wounds with complex wound topography and is suitable for burns, blast injuries, lacerations of the perineum, anus, axilla, and submandibular area, as well as blast injuries caused by crushing of the limbs. Because the arc curvature of the separator gradually and smoothly decreases, the absolute support height reaches the relative optimal value required for wound healing physiology. The number, height, and curvature of the separators determine the number and size of the conduction cavities, and thus the anti-blocking effect; in order to ensure the stability of the separators, the bottom diameter of the separators is set to no more than 10 mm, the height is set to no more than 6 mm, and the hardness is set to 5 to 40 degrees.

[0098] The drainage structure proposed in the present invention can conduct negative pressure continuously and evenly across the entire wound surface. Due to its porous and multi-support design, it allows for smooth drainage without blockage. When used in combination with PVA material, it provides a pathway that will not dry out and collapse, and has a certain moisturizing effect, preventing the PVA material from drying out and hardening. At the same time, its resilience and permeability are greatly improved. It is easy to seal, rinse, and drain, thus significantly improving the therapeutic effect and efficiency.

[0099] While the specific embodiments of the present invention have been described in detail above, these are merely exemplary and the present invention is not limited thereto. 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, any equivalent changes and modifications made without departing from the spirit and scope of the present invention are intended to be encompassed within the scope of the present invention.

Claims

1. A drainage structure for continuous and uniform negative pressure conduction across the entire wound surface, used in conjunction with a porous foam layer (2) for negative pressure drainage operations, characterized in that: It includes a structural body (1); a separator (3) is arranged on the side of the structural body (1) opposite to the porous foam layer (2), and a cavity (4) is formed between the structural body (1) and the porous foam layer (2) by the separator (3). A through hole (5) is provided at the position of the structural body (1) opposite to the cavity (4), and the through hole (5) communicates the upper space and the lower space of the structural body (1).

2. The drainage structure for continuous and uniform negative pressure conduction across the entire wound surface according to claim 1, wherein: One end of the separator (3) is a fixed end (3-1) fixed on the structural body (1), and the other end is a top end (3-2). The volume of the separator (3) tapers from the fixed end (3-1) to the top end (3-2), so that the cavity (4) forms a gradually expanding surface from the fixed end (3-1) to the top end (3-2) along the surface of the separator (3).

3. The drainage structure with continuous and uniform negative pressure conduction for the entire wound surface according to claim 2, characterized in that: The fixed end (3-1) is circular or regular polygonal, and the top end (3-2) is a vertex or an end face.

4. The drainage structure with continuous and uniform negative pressure conduction for the entire wound surface according to claim 1, characterized in that: The ratio of the distance d2 between adjacent separators (3) on the structural body (1) to the bottom width d1 of the separator (3) is 0.2 to 3.

5. The drainage structure for continuous and uniform negative pressure conduction across the entire wound surface according to claim 1, wherein: The separator (3) is a solid of revolution, and the generatrix of the solid of revolution is a straight generatrix or a curved generatrix.

6. The drainage structure with continuous and uniform negative pressure conduction across the entire wound surface according to claim 1, wherein: The axial section of the separator (3) is one or a combination of two of a triangle, a trapezoid, a circle, a semi-circle, an ellipse, a rectangle, and a parallelogram.

7. The drainage structure with continuous and uniform negative pressure conduction for the entire wound surface according to claim 1, characterized in that: The separator (3) is a columnar structure, and a plurality of flange structures extend outwards axially.

8. The drainage structure with continuous and uniform negative pressure conduction for the entire wound surface according to claim 7, wherein: The front end of the flange structure is an arc surface or a conical surface.

9. The drainage structure with continuous and uniform negative pressure conduction across the wound surface according to claim 1, characterized in that: The outer surface of the separator (3) is provided with protrusions distributed uniformly or non-uniformly.

10. The drainage structure for continuous and uniform negative pressure conduction across the entire wound surface according to claim 1, wherein: The surface of the structural body (1) close to the wound surface is connected to the porous foam layer (2), and the surface of the structural body (1) far from the wound surface is communicated with one or more suction cups (7).

11. The drainage structure with continuous and uniform negative pressure conduction across the wound surface according to claim 10, characterized in that: The porous foam layer (2) is made of one or more of polyvinyl alcohol resin PVA, modified polyvinyl alcohol resin PVA, polyurethane elastomer PU, or modified polyurethane elastomer PU.

12. The drainage structure with continuous and uniform negative pressure conduction for the entire wound surface according to claim 10, wherein: A sealing film (6) is arranged on the surface of the structural body (1) far from the wound surface. A drainage hole (8) is provided on the sealing film (6). The skirt of the suction cup (7) is attached to the semi-permeable membrane, and the middle cavity of the suction cup (7) is opposite to the position of the drainage hole (8).

13. The drainage structure for continuous and uniform negative pressure conduction across the entire wound surface according to claim 12, characterized in that: The surface of the structural body (1) far from the wound surface is a rough plane.

14. The drainage structure with continuous and uniform negative pressure conduction across the wound surface according to claim 1, characterized in that: The structural body (1) and the porous foam layer (2) are fixedly connected by suture or adhesion.

15. The drainage structure for continuous and uniform negative pressure conduction across the entire wound surface according to claim 14, characterized in that: The fixing points between the structural body (1) and the porous foam layer (2) are evenly distributed.

16. The drainage structure with continuous and uniform negative pressure conduction for the whole wound surface according to claim 1, wherein: The structural body (1) is flocked on the surface of the porous foam layer (2) by a coating process and then heat-dried.

17. The drainage structure with continuous and uniform negative pressure conduction for the whole wound surface according to any one of claims 1 to 16, characterized in that: There are several separators (3), which are evenly arranged on the surface of the structural body (1) close to the wound surface.

18. The drainage structure for continuous and uniform negative pressure conduction across the entire wound surface according to any one of claims 1 to 16, characterized in that: The bottom diameter of the separator (3) is not more than 10 mm, and the height is not more than 6 mm.

19. The drainage structure with continuous and uniform negative pressure conduction for the whole wound surface according to any one of claims 1 to 16, characterized in that: The porosity of the structural body (1) is 15% to 70%.

20. The drainage structure for continuous and uniform negative pressure conduction across the entire wound surface according to any one of claims 1 to 16, characterized in that: The structural body (1) and the separator (3) are made of thermosetting elastomer, rubber, or thermoplastic elastomer.

21. The drainage structure for continuous and uniform negative pressure conduction across the entire wound surface according to any one of claims 1 to 16, characterized in that: The structural body (1) is formed by a replication molding process, an injection molding process, or a compression molding process.

22. The drainage structure with continuous and uniform negative pressure conduction for the entire wound surface according to any one of claims 1 to 16, characterized in that: The hardness range of the structural body (1) is: 5 to 35 degrees, and the hardness range of the separator (3) is: 5 to 40 degrees.

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