Sealed device for stinger wounds and method of making the dressing filled therewith

Abstract

The application discloses a sealing device for a nail channel wound and a preparation method of a filled dressing thereof, and belongs to the technical field of biomaterials and medical dressings. The technical scheme is as follows: the sealing device for a hole-shaped wound comprises two groups of shells arranged symmetrically, the tail portions of the two groups of shells are hingedly connected through rotating shafts, torsional springs are arranged between the tail portions of the two groups of shells, the inner sides of the head portions of the two groups of shells are each provided with a sealing piece, the two groups of sealing pieces are matched with each other, the inner sides of the top portions of the two groups of sealing pieces are each provided with a semicircular hole matched with each other, the outer sides of the bottom portions of the two groups of sealing pieces are each provided with a skirt, and the interiors of the two groups of sealing pieces are provided with antibacterial dressings; the preparation method is that the internal antibacterial dressing is prepared through cold freeze drying method by alternately immersing a polyurethane sponge matrix into a zinc ion solution and a sodium alginate solution for short-time crosslinking for multiple times. The application can conveniently change dressings, is simple to operate, can seal wounds, reduces the infection probability, and effectively improves the nursing efficiency and nursing effect.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of biomaterials and medical dressings, and particularly relates to a sealed device for a pin channel wound and a preparation method of a dressing filled therein. BACKGROUND

[0002] There are 180 million new fractures worldwide each year, and fracture external fixation and bone traction surgery is a common surgery in orthopedics, which requires bone needles to penetrate the bone marrow to form a mechanical fixation point to achieve fracture healing or traction of the fracture end. This process will form a pin channel wound for 2-3 months. Since the pin channel wound reaches the bone marrow cavity and is continuously open, the literature reports that the infection rate of the wound is 30-80%, and severe cases can cause osteomyelitis to cause disability. In addition, infection can also cause the bone pin to loosen, increase the risk of fixation failure, prolong hospitalization time, and significantly increase medical costs. Therefore, the disposal of the pin channel wound has become a global problem plaguing the field of orthopedics.

[0003] At present, the common method for disposing the pin channel wound is to wrap the wound with gauze after debridement, that is, to wrap the gauze around the pin channel. The prior art at least has the following problems: first, it cannot effectively prevent bacteria from invading the wound, and wound infection cannot be prevented, second, the gauze and the pin channel wound are easy to adhere and scab, which causes the inflammatory exudate in the deep part of the wound to be unable to be effectively discharged, increasing the probability of deep infection, third, the dressing is difficult to replace, the patient has obvious pain, and the medical staff is difficult to dispose, time-consuming and laborious. In addition, the unique pathophysiological characteristics of the pin channel wound make it easy for pathogenic bacteria such as Staphylococcus aureus to form a biofilm, leading to persistent and aggravated infection and causing severe local and systemic inflammatory reactions. This not only increases the incidence of complications, but even causes disability and endangers life.

[0004] Therefore, it is necessary to develop a sealed device suitable for the pin channel wound to solve the key problems in the nursing of the pin channel wound. SUMMARY

[0005] The present application provides a sealed device for a pin channel wound and a preparation method of an internal dressing thereof, which realizes the cooperation of the special physiological disposal requirements of the pin channel wound and the active and passive synergistic antibacterial effect, can not only effectively prevent bacterial invasion of the pin channel wound, but also effectively prevent the accumulation of inflammatory exudate in the deep part of the wound. The sealed device can also significantly weaken the virulence of pathogenic bacteria, has high wound disposal efficiency and no secondary damage. It is expected to provide a novel solution for the management of the pin channel wound, significantly improve the treatment effect of the patient, and reduce the consumption of medical resources.

[0006] The technical scheme of the present application is as follows:

[0007] In a first aspect, a sealing device for a nail track wound is disclosed, comprising two sets of housings symmetrically arranged, the tail portions of the two sets of housings are hingedly connected through a rotating shaft, a torsional spring is arranged between the tail portions of the two sets of housings, the inner sides of the head portions of the two sets of housings are each provided with a sealing member, the two sets of sealing members are matched with each other, the inner sides of the top portions of the two sets of sealing members are each provided with a semicircular hole matched with each other, the outer sides of the bottom portions of the two sets of sealing members are each provided with a skirt, and the interiors of the two sets of sealing members are provided with a main and passive collaborative antibacterial dressing.

[0008] Preferably, the inner side surface of the head portion of the housing is in a "C" shape, which can form a stable support framework, press the sealing member when closed, and prevent leakage.

[0009] Preferably, the skirt is arranged in a downward inclination, which can further improve the fitting effect of the skirt with the skin.

[0010] Preferably, the inner side of the bottom portion of the sealing member is horizontally provided with a patch, which can cooperate with the skirt to further improve the fitting effect of the bottom portion of the sealing member with the skin and reduce the probability of infection caused by bacteria entering the wound.

[0011] Preferably, the inner side wall of the sealing member is provided with a groove, which can reduce the thickness of the sealing member, increase the softness, and provide the fitting effect of the skirt with the skin.

[0012] In a second aspect, a preparation method of the antibacterial dressing is disclosed, which is prepared by alternately immersing a polyurethane sponge matrix into a zinc ion solution and a sodium alginate solution for short-time crosslinking multiple times, and then freeze-drying.

[0013] Preferably, the preparation method of the dressing comprises the following steps:

[0014] 1) Immersing the polyurethane sponge into the sodium alginate solution, standing, and squeezing the residual sodium alginate on the surface of the sponge;

[0015] 2) Immersing into the zinc chloride solution, standing, immersing into the prepared sodium alginate solution again, and standing;

[0016] 3) Repeating step 2), finally immersing into the zinc chloride solution and placing in a shaking bed for reaction, and then freeze-drying to obtain the antibacterial dressing.

[0017] Preferably, the standing time in step 1) is 2-5 min.

[0018] Preferably, the time for single immersion in the zinc chloride solution in step 2) is 10-20s, the time for single immersion in the sodium alginate solution is 10-20s, and the number of repetitions in step 3) is 3-6.

[0019] Preferably, the concentration of sodium alginate is 0.01-0.02g / mL, the concentration of zinc ions is 8-20mg / mL, the shaking table reaction temperature in step 3) is 37℃, and the reaction time is 2-6h.

[0020] Compared with the prior art, the present application has the following beneficial effects:

[0021] 1. The closed device of the present application is based on the principle of "upper sealing and lower leading", and realizes the plugging of external pathogens and the efficient management of internal inflammatory exudates through the combination of physical barriers and active and passive sterilization materials. The sodium alginate-zinc ion gel layer is passive sterilization, and the zinc ions are active sterilization. The device can facilitate dressing change, is simple to operate, can close the wound, reduces the probability of infection, effectively improves the nursing efficiency and effect, and significantly solves the treatment problem under the complex pathophysiological characteristics of the nail channel wound.

[0022] 2. The closed device for nail channel wounds of the present application can form a clamp structure by setting the shell, shaft and torsional spring, which facilitates manual opening and installation by medical staff. After the hand is released, the two sets of shells can clamp the external fixation needle or drainage tube under the action of the torsional spring shaft, avoiding falling off. By setting the closure, a cavity can be formed with the shell, which can be covered on the hole-shaped wound for protection and fixation of the antibacterial dressing. The two sets of closures can also be opened to facilitate installation, and can form a closed cavity when the two sets of shells are closed. By setting the semicircular holes, a complete circular hole can be formed to stably clamp the external fixation needle or drainage tube, effectively sealing the connection and reducing the probability of infection caused by bacteria entering the wound, without adversely affecting the external fixation needle or drainage tube. By setting the skirt, a suction disc-like structure can be formed to fully adhere to the skin and achieve airtightness. By setting the antibacterial dressing, the blood and tissue fluid exuded from the wound can be continuously absorbed, reducing the frequency of wound soaking and dressing replacement.

[0023] 3. The closed device for nail channel wounds of the present application has high bacterial barrier and exudate management capability: the closed device forms a first physical barrier by designing the shell, effectively blocking the invasion of external pathogenic bacteria, and further improves the prevention and control by combining with the internal active sterilization material. The dressing uses a hydrophilic material based on polyurethane sponge, which forms a more stable three-dimensional network structure through instant multiple coating technology, can more efficiently absorb and discharge the inflammatory exudate from the wound, significantly reduces the inflammatory reaction, and prevents the spread of infection to the deep bone marrow cavity.

[0024] 4. The sealing device for nail channel wounds has significant antibacterial and virulence inhibition effects: the antibacterial rate of the sealing device for E. coli and S. aureus is as high as 90%, the antibacterial efficiency is more than 95%, and the liquid absorption rate is several times that of traditional gauze. In in vivo experiments, the sealing device significantly reduces local inflammation, reduces bacterial load and S. aureus abundance, and increases the diversity and richness of health-related flora.

[0025] 5. The present application adopts the technology of instantaneous multiple cross-linking, which is different from the traditional method of one-time cross-linking reaction and solidification into gel. The instantaneous multiple cross-linking refers to the continuous or multiple introduction of zinc ions during the gel formation process, aiming to enhance the cross-linking density of the gel network, thereby constructing a more stable three-dimensional network structure.

[0026] 6. The sealing device for nail channel wounds has good clinical transformation and economy: the design of the sealing device fully considers patient comfort and clinical ease of use, realizes painless replacement, simple and rapid, significantly reduces the risk of infection and patient pain in medical operations. The simple and practical design of the sealing device has good clinical transformation potential, and the cost is relatively low, which is expected to be widely used in clinical practice and reduce the consumption of medical resources. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 The loading surface structure diagram and application schematic diagram of the sealing device for dry nail channel wound damage of the present application.

[0028] Figure 2 The sealing device for nail channel wounds of the present application Figure 1 .

[0029] Figure 3 The sealing device for nail channel wounds of the present application Figure 2 .

[0030] Figure 4 The schematic diagram of the shell and the sealing element in the sealing device for nail channel wounds of the present application.

[0031] Figure 5 The exploded schematic diagram of the shell and the sealing element in the sealing device for nail channel wounds of the present application.

[0032] Figure 6 The surface morphology diagram of polyurethane (PU), ZAPU prepared in Example 1, ZAPU-L prepared in Comparative Example 2, and SAPU prepared in Comparative Example 1 of the present application.

[0033] Figure 7 The zinc ion release diagram of polyurethane (PU), ZAPU prepared in Example 1, ZAPU-L prepared in Comparative Example 2, and SAPU prepared in Comparative Example 1 of the present application.

[0034] Figure 8 Water absorption rate results chart for the gauze, PU, SAPU prepared in Comparative Example 1, and ZAPU prepared in Example 1 of the present application.

[0035] Figure 9 Porosity results chart for the PU, SAPU prepared in Comparative Example 1, and ZAPU prepared in Example 1 of the present application.

[0036] Figure 10 Permeability results chart for the PU, SAPU prepared in Comparative Example 1, ZAPU prepared in Example 1, and the blank control group of the present application.

[0037] Figure 11 In vitro antibacterial performance results chart for the PU, SAPU prepared in Comparative Example 1, ZAPU prepared in Example 1, and the blank control group of the present application.

[0038] Figure 12 In vitro bacterial resistance performance results chart for the PU, SAPU prepared in Comparative Example 1, ZAPU prepared in Example 1, and the blank control group of the present application.

[0039] Figure 13 Biological safety test (cytotoxicity a, hemolyticity b) results chart for the ZAPU dressing prepared in Example 1 of the present application.

[0040] Figure 14 Peg canal wound chart for the gauze group and the closed device group on the 7th day and the 14th day of the pig peg canal infection (PSI) model of the present application.

[0041] Figure 15 CT imaging of the peg canal and bone structure after the 14th day for the gauze group and the closed device group in the pig peg canal infection (PSI) model of the present application.

[0042] Figure 16 Chart of the soft tissue and medullary cavity after the 14th day for the gauze group and the closed device group in the pig peg canal infection (PSI) model of the present application.

[0043] Figure 17 Chart of the systemic inflammatory marker levels for the gauze group and the closed device group in the pig peg canal infection (PSI) model of the present application.

[0044] Figure 18 Histological analysis results chart for the gauze and the closed device in the pig peg canal infection (PSI) model of the present application.

[0045] Figure 19 Results chart for immunohistochemical staining of IL-1β to evaluate the inflammatory response of the peg canal in the pig peg canal infection (PSI) model of the present application.

[0046] Figure 20 Representative images of bacterial colonies on agar plates from samples collected at day 7 and day 14 from the pin tract wound site in the gauze group and the closed device group in the pig model of pin site infection (PSI) of the present application.

[0047] Figure 21 Classification of the microbiota at genus level based on 16S rRNA sequencing analysis of the pin tract wound microbiota at day 14 in the gauze group and the closed device group in the pig model of pin site infection (PSI) of the present application.

[0048] Figure 22 Microbial composition at genus level in the gauze group in the pig model of pin site infection (PSI) of the present application.

[0049] Figure 23 Microbial composition at genus level in the closed device group in the pig model of pin site infection (PSI) of the present application.

[0050] Figure 24 Graph of the microbial diversity results in the gauze group and the closed device group in the pig model of pin site infection (PSI) of the present application.

[0051] Figure 25 Graph of the Simper analysis results in the gauze group and the closed device group in the pig model of pin site infection (PSI) of the present application.

[0052] Figure 26 Graph of the T-test analysis results in the gauze group and the closed device group in the pig model of pin site infection (PSI) of the present application.

[0053] Figure 27 Surface topography of the dressing prepared in Comparative Example 3 of the present application.

[0054] Figure 28 Surface topography of the dressing prepared in Comparative Example 4 of the present application.

[0055] Figure 1, housing; 2, rotating shaft; 3, closure; 4, semicircular hole; 5, semicircular opening; 6, skirt; 7, plug; 8, slot; 9, patch; 10, groove; 11, handle; 12, torsional spring. DETAILED DESCRIPTION

[0056] In order to make the personnel in the technical field better understand the technical solutions in the present application, the technical solutions in the embodiments of the present application will be described clearly and completely below in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by the person of ordinary skill in the art without making creative efforts should belong to the protection scope of the present application.

[0057] The schematic diagram of the loading surface structure of the closed device for treating the wound of the nail track and the application schematic diagram are shown in Figure 1

[0058] The closed device for treating the wound of the nail track, the specific structure is shown in Figures 2 to 5 The two groups of shell bodies 1 are hinged through the rotating shaft 2 at the tail parts, and the two groups of shell bodies 1 are closed through the compressed torsion spring 12 after being hinged together, the inner side of the head part of the two groups of shell bodies 1 is respectively provided with the closed part 3, the closed part 3 is made of soft material, the two groups of closed parts 3 are matched with each other, the inner side of the top part of the two groups of closed parts 3 is respectively provided with the semicircular hole 4 matched with each other, the bottom part of the two groups of closed parts 3 is respectively provided with the semicircular opening 5 matched with each other, the outer side of the semicircular opening 5 is provided with the skirt 6, and the inner part of the two groups of closed parts 3 is provided with the antibacterial dressing.

[0059] The shell body 1, the rotating shaft 2 and the torsion spring 12 are arranged to form a clamp structure, which is convenient for medical staff to manually open and install, and after the hand is released, the two groups of shell bodies 1 can clamp the fracture external fixation needle or the drainage tube under the action of the torsion spring 12, so as to avoid falling off, the closed part 3 is arranged to form a cavity together with the shell body 1, which can be covered on the hole-shaped wound to protect and fix the antibacterial dressing, the two groups of closed parts 3 can be opened together with the corresponding shell body 1 to facilitate installation, and can form a closed cavity when the two groups of shell bodies 1 are closed, the semicircular hole 4 is arranged to form a complete circular hole by matching with each other, so as to stably clamp the fracture external fixation needle or the drainage tube, which can effectively seal the connection part, reduce the infection probability caused by the bacteria entering the wound, and will not have adverse effects on the fracture external fixation needle or the drainage tube, the skirt 6 is arranged to form a sucker structure by matching with each other, which can be fully attached to the skin to achieve the sealing effect, and the antibacterial dressing is arranged to continuously absorb the blood and tissue fluid exuded from the wound, so as to reduce the soaking of the wound and the replacement frequency of the dressing.

[0060] As shown in Figures 2 to 5 The inner side of the head part of the shell body 1 is in a “C” shape, which can form a stable support framework and press the closed part 3 when closed to prevent leakage.

[0061] As shown in Figure 5 The inner side of the head part of the shell body 1 is in a “C” shape, which can form a stable support framework and press the closed part 3 when closed to prevent leakage.

[0062] As shown in Figures 2 to 5 The skirt 6 is arranged to be inclined downward, which can further improve the attachment effect of the skirt 6 and the skin.

[0063] As shown in Figure 4 ​As shown, a patch 9 is horizontally provided on the inner side of the bottom of the sealing component 3. By setting the patch 9, firstly, it can work with the skirt 6 to further improve the fit between the bottom of the sealing component 3 and the skin, reducing the probability of infection caused by bacteria entering the wound; secondly, it can support and fix the antibacterial dressing.

[0064] like Figure 4 As shown, a groove 10 is provided on the inner wall of the sealing member 3. By providing the groove 10, the thickness of the sealing member 3 can be reduced, the softness can be increased, and the fit between the skirt edge 6 and the skin can be improved.

[0065] like Figure 2 and Figure 3 As shown, both sets of housings 1 are equipped with a handle 11 at their tail ends. The handle 11 makes it convenient for medical staff to open the two sets of housings 1.

[0066] In use, the antibacterial dressing ZAPU prepared in Example 1 is used. Medical personnel open both sets of housings 1 via handle 11. The two sets of housings 1 open the two sets of sealing elements 3. Then, the two sets of antibacterial dressing ZAPU are placed into the two sets of sealing elements 3 respectively, and positioned above the patch 9, with the bottom of the antibacterial dressing ZAPU tucked into the groove and the tops of the two sets of antibacterial dressing ZAPU corresponding to each other. Next, the two sets of sealing elements 3 are positioned on both sides of the fracture external fixation needle or drainage tube, aligning the fracture external fixation needle or drainage tube with the semi-circular hole 4. Then, pressure is applied to ensure the patch 9 and skirt 6 are fully adhered to the skin. Handle 11 is released, and under the action of torsion spring 12 and rotating shaft 2, housing 1 drives the sealing elements 3 to close the two sets of semi-circular holes 4. The fracture external fixation needle or drainage tube is clamped, and the tops of the two sets of antibacterial dressing ZAPU continuously absorb exudate of blood and tissue fluid, reducing wound maceration and the frequency of dressing changes.

[0067] Example 1

[0068] The preparation method of the antibacterial dressing ZAPU includes the following steps:

[0069] 1) Immerse the polyurethane sponge (PU, purchased from Silikang Medical Materials (Tianchang) Co., Ltd.) in a solution of dissolved sodium alginate (SA, purchased from Qingdao Jueda Algae Industry Group Co., Ltd.) (viscosity 80mPas, 0.01g / mL), let it stand for 5 minutes, and gently squeeze off the sodium alginate residue on the surface of the sponge.

[0070] 2) Immerse the polyurethane sponge containing sodium alginate in zinc chloride (Sigma-Aldrich, USA) solution (12 mg / mL) for 10 seconds, then immerse it again in the prepared sodium alginate solution (viscosity 80 mPas, 0.01 g / mL) and let it stand for 10 seconds.

[0071] 3) After repeating step 2) three times, finally put into zinc chloride solution (12 mg / mL) and placed in a 37°C shaker for 2h, freeze-dried to obtain the antibacterial dressing ZAPU.

[0072] Comparative Example 1

[0073] The preparation method of the dressing SAPU is: directly immerse the polyurethane sponge PU into the sodium alginate solution (viscosity of 80 mPas, 0.01 g / mL) and placed in a 37°C shaker for 2h, freeze-dried to obtain the dressing SAPU.

[0074] Comparative Example 2

[0075] The preparation method of the dressing ZAPU-L is: by blending method, first immerse the polyurethane sponge PU into the zinc ion solution (12 mg / mL) and then directly add the sodium alginate solution (viscosity of 80 mPas, 0.01 g / mL), and placed in a 37°C shaker for 2h, freeze-dried to obtain the dressing ZAPU-L.

[0076] Comparative Example 3

[0077] Different from Example 1, step 2) is to immerse in zinc chloride solution (12 mg / mL) for 20 seconds, and then immerse in the prepared sodium alginate solution for 20 seconds again; the rest is the same as Example 1, the surface morphology of the prepared dressing is shown in Figure 27 , the sponge inside the opening structure appears a wrinkled state of gelation, and the level is unclear.

[0078] Comparative Example 4

[0079] Different from Example 1, step 3) is changed from "repeat step B) three times" to "repeat step B) once"; the rest is the same as Example 1, the surface morphology of the prepared dressing is shown in Figure 28 , the morphology and structural integrity of the sponge is not affected. And it shows similar opening structure and soft foam characteristics as the base sponge.

[0080] The antibacterial dressing prepared in Example 1 and the dressings prepared in Comparative Examples 1-2 were subjected to physicochemical property characterization and biological performance test, as follows:

[0081] The pore structure changes of the antibacterial dressing ZAPU prepared in Example 1, the dressing ZAPU-L prepared in Comparative Example 2, the dressing SAPU prepared in Comparative Example 1 and the polyurethane sponge PU were observed by scanning electron microscope to confirm the uniformity of the coating and the integrity of the porous structure, and the results are shown in Figure 6As shown in the figure, it can be seen that the polyurethane sponge PU and the ZAPU prepared in Example 1 both exhibit a porous and interconnected structure, and the ZAPU prepared in Example 1 maintains good porous properties after modification, and the surface appears a gelated wrinkle structure, that is, the sodium alginate-zinc ion gel layer adheres to the surface of the sponge after freeze-drying to form an uneven interface. Compared with the blended cross-linked ZAPU-L prepared in Comparative Example 2, the pore structure of the ZAPU prepared in Example 1 is more stable and hierarchical. The internal open pore structure of the SAPU prepared in Comparative Example 1 is loose and not clear, and the sodium alginate is easy to block the sponge pore after drying.

[0082] The zinc ion release performance of the antibacterial dressing ZAPU prepared in Example 1, the dressing ZAPU-L prepared in Comparative Example 2, the dressing SAPU prepared in Comparative Example 1 and the polyurethane sponge PU was explored. Specifically, an Elabscience zinc (Zn) colorimetric assay kit was used. The zinc ions in the sample can form a colored complex with the chromogenic agent 5-Br-PADAP in the reagent, and the color depth is proportional to the zinc ion concentration. The extract of ZAPU, ZAPU-L, SAPU and PU was mixed with the reagent two (protein precipitant) at a volume ratio of 1:1, centrifuged at 4°C and a centrifugal force of 13780 for 10 min, and the supernatant was taken for testing. After adding the chromogenic agent and measuring the OD value using an enzyme marker (545-575 nm), the zinc ion concentration was calculated according to the formula provided by the test kit: (concentration (μmol / L) = (ΔA 560-b ) ÷ a x 2 * x f; where y = 0.01534x-0.00139, R 2 = 0.9997; y: OD value of standard well-OD value of blank well (OD value when the standard concentration is 0), x: concentration of standard, a: slope of standard curve, b: intercept of standard curve f: dilution multiple of sample before adding to the detection system, 2*: dilution multiple during sample pretreatment). The test results are shown in Figure 7 As shown in the figure, it can be seen that the zinc ion release performance of the antibacterial dressing ZAPU prepared in Example 1 gradually increases with the extension of the soaking time, indicating that the antibacterial dressing ZAPU prepared in Example 1 can achieve slow and continuous release of zinc ions, enhancing the antibacterial effect. Compared with the ZAPU-L dressing prepared in Comparative Example 2, the gelation modification for a short time multiple times can achieve long-term and continuous release of zinc ions. PU and SAPU have no zinc ions added, and the release amount in each time period is 0.

[0083] The water absorption capacity of the wound dressing is an important property for evaluating the cleaning effect of wound exudate. An ideal wound dressing should maintain the moisture of the wound while effectively preventing excessive exudate from accumulating on the surface of the wound.​

[0084] The water absorption rate of commercially available gauze (referred to as Guaze), polyurethane sponge PU, the dressing SAPU prepared in Comparative Example 1, and the antibacterial dressing ZAPU prepared in Example 1 was determined, and the water absorption rate can be evaluated according to the method of YY / T0471.1-2004. The gauze, PU, SAPU, and ZAPU dry samples used for measurement were weighed in triplicate, then immersed in phosphate buffered saline (PBS, pH = 7.4), and finally placed in an oven at 37°C for 10 minutes. After standing for 30 seconds, the sample was taken out with tweezers, weighed until the droplet formation stopped, and the water absorption capacity of the sponge was calculated according to the formula.

[0085]

[0086] In the formula: m1- initial mass of sponge, g; M2- mass of sponge after absorbing water, g. The test results are shown in Table 1. Figure 8 The weight of the gauze after absorption is 1.2 times its dry weight, while the weight of the ZAPU prepared in Example 1 after absorption is 15 times its dry weight, which is significantly higher than that of the gauze, and the absorption capacity has not been weakened after modification, and the weight after absorption is also increased compared with PU and SAPU. It shows that the ZAPU prepared in Example 1 has extremely strong liquid absorption capacity.

[0087] Porosity generally affects the performance of biomaterials, including liquid absorption, water retention, and water vapor permeability. The porosity of polyurethane sponge PU, the dressing SAPU prepared in Comparative Example 1, and the antibacterial dressing ZAPU prepared in Example 1 was determined by liquid volume displacement method. The sample was weighed and its volume was measured and calculated (cylindrical, radius r about 1.1 cm, thickness h about 0.5 cm), its mass was weighed and recorded as W1, and it was placed in anhydrous ethanol and soaked for 5 min to fully absorb the anhydrous ethanol. Then the sample was taken out from the anhydrous ethanol, the excess anhydrous ethanol was gently absorbed and wiped off, and immediately weighed and recorded the mass W2. The porosity of the sample was calculated using the following formula:

[0088]

[0089] where W1 and W2 are the initial weight and the final weighed weight of the sponge sample, respectively. The porosity was calculated based on three parallel sample tests, expressed as the arithmetic mean and standard deviation (M ± SD, n = 3). The test results are shown in Table 2. Figure 9As shown, the results show that the porosity of ZAPU prepared in Example 1 is 83.14±0.3%, higher than that of PU (80.96±1.3%) and SAPU prepared in Comparative Example 1 (80.10±0.5%), indicating that the short-time and multiple modification method increases the interconnectivity of the pores, and the interconnected pores increase the specific surface area of the sponge, so that more ethanol is absorbed in the pores, thereby increasing the measured porosity. Combined with the scanning electron microscope (SEM) images Figure 6 Analysis, ZAPU prepared in Example 1 exhibits a regular and complete porous structure, providing an advantage of efficient absorption of exudates for its application in wound dressings.

[0090] An ideal wound dressing should maintain the moisture of the wound while effectively preventing excessive exudate from accumulating on the wound surface. A certain degree of moisture and gas permeability through the wound dressing is important to prevent excessive dehydration and exudate accumulation in the wound. Therefore, appropriate water vapor transmission rate (WVTR) is also particularly important. The transmission rate of the antibacterial dressing ZAPU prepared in Example 1, the SAPU dressing prepared in Comparative Example 1, and PU was determined, and the water vapor transmission rate (WVTR) of the dressing was measured according to YY / T0471.2-2004. First, a certain amount of pure water was added to a centrifuge tube, and the sponge dressing ZAPU, SAPU and PU prepared in Example 1 were cut into uniform shapes and placed at the opening of the centrifuge tube, and then the device was placed in a constant temperature incubator at 37°C. After different time periods, the volume change was measured. The specific formula is as follows:

[0091]

[0092] In the formula: m0- the initial mass of the centrifuge tube device with sponge and water, g;

[0093] m t - the mass of the entire device after time t, g;

[0094] S- the area of the centrifuge tube opening, mm;

[0095] t- the number of days the entire device is placed in the constant temperature incubator, d; the control group is the blank group, i.e. the bottle opening is not covered with any dressing. The test results are shown in Figure 10 As shown, the results show that the water vapor transmission performance (WVTR) of ZAPU prepared in Example 1 is 2875.4 g·m 2 / day, which is significantly lower than that of the blank group (14708.9 g·m 2 / day), reducing water loss by 80.45%. Compared with PU and SAPU prepared in Comparative Example 1, ZAPU prepared in Example 1 maintains an ideal water vapor transmission rate, which helps to regulate the moisture of the wound and avoid excessive dehydration.

[0096] In vitro antibacterial performance exploration: Colony counting method was used to evaluate the antibacterial activity of polyurethane sponge PU, comparative example 1 prepared SAPU and example 1 prepared ZAPU against E. coli and S. aureus. PU, SAPU and ZAPU sponges were cut into a cylinder with a height of 5 mm and a diameter of 20 mm, and then ultraviolet sterilized for 30 min. 4 mL of PBS was added to the sterilized sponge for sufficient soaking, followed by the addition of 200 uL of S. aureus and E. coli bacterial solution (10 6 CFU / mL) respectively, and incubated at 37°C for 2 h. After incubation, the bacterial solution was diluted and 100 uL of bacterial solution was spread on agar plates. After incubation at 37°C for 24 h, the colonies on the agar plates were observed and photographed, as shown in Figure 11 Example 1 prepared ZAPU, compared with the blank control group, the inhibition rates of PU and comparative example 1 prepared SAPU against S. aureus were 0 and 8.5% ± 1.0, respectively, and the antibacterial rates of PU and comparative example 1 prepared SAPU against E. coli were 11.25% ± 0.9 and 36.36% ± 1.9, respectively. The antibacterial effect of example 1 prepared ZAPU was significantly better than that of the two, and the antibacterial rates of ZAPU against S. aureus (90.23% ± 0.5) and E. coli (91.23% ± 1.2) were both excellent, mainly due to the inhibition of zinc ions on bacterial biofilm and its metabolic interference.

[0097] To test the in vitro bacterial barrier performance of the hard shell combined with the ZAPU prepared in example 1, the antibacterial effect of polyurethane sponge PU, comparative example 1 prepared SAPU and example 1 prepared antibacterial dressing ZAPU combined with hard shell (the hard shell is the part of the sealed device for nail channel wound without dressing) was evaluated. The specific method is as follows: after ultraviolet sterilization of the cylindrical sponge with a height of 10 mm and a diameter of 22 mm for 30 min, it was embedded in a rubber shell and ultraviolet sterilized again. Then it was placed in a 25 mm diameter and 15 mm high acrylic cylinder, and a 22 mm diameter hyaluronic acid air filter membrane (HAFM) was placed on a clean transparent plate. It is worth noting that HAFM is a porous structure filter membrane constructed by ethanol-induced phase separation strategy (patent 202410540252.7, example 1, porous filter membrane for efficient capture and instant quantitative detection of air pathogens), and the bottom of the cylinder is in contact with the filter membrane (but not with the polyurethane sponge). An aerosol bottle containing S. aureus (S. aureus, ATCC29213) and E. coli (E. coli, ATCC8739) bacterial solution (1 × 10 4CFU / L, 5 mL) was sprayed over the top of the pvc cylinder, which was aligned with the sponge of the dressing, and the spraying was timed for 30 s. After the spraying was completed, the HAFM was left to stand for 1 min, and then it was removed and placed in a LB Petri dish for 30 s, after which the membrane was dissolved and the plate was prepared. After incubation at 37 °C for 24 h, the colonies on the agar plate were observed and photographed, as shown in Figure 12 The results showed that the passive antibacterial performance of the closed device (referred to as PINSHIELD) was significantly better than that of the traditional gauze dressing, with a bacterial blocking rate of 99% for both S. aureus and E. coli. The first physical barrier of the closed device effectively prevented the invasion of exogenous bacteria, but due to the short duration of the test, the functional inner layer did not yet have the ability to kill bacteria, and only a few bacteria entered the bottom filter membrane through the gap and colonized. The gauze had a pore size that was too large and was difficult to attach bacteria, with a bacterial blocking effect of 20% ± 0.4 for S. aureus and only 16.8% ± 1.6 for E. coli.

[0098] Biocompatibility is a basic prerequisite for the clinical transformation of wound dressings. To test the biocompatibility of the antibacterial dressing ZAPU prepared in Example 1, we conducted cytotoxicity tests and hemolysis tests.

[0099] CCK-8 method was used to evaluate the cytotoxicity of the dressing. L929 cells were cultured in DMEM medium containing 10% fetal bovine serum and double antibodies. The ZAPU prepared in Example 1 was soaked in high-sugar culture medium DMEM for 24 hours, and then filtered using a 0.22 μm filter membrane (Sartorius, Germany) to obtain a sponge extract. Then it was diluted to 0.25, 0.5, 0.75 and 1 mg / mL. The concentration of L929 cells was adjusted to 5 x 10 4 cells / mL, 100 μL per well was inoculated in a 96-well plate, and after the cells adhered, the different concentrations of sponge extract were replaced, and then 100 μL of sponge extract was used to replace the culture medium for further culture for 24 h and 72 h. After the corresponding time of culture, the original culture medium was aspirated, 100 μL of CCK-8 detection solution (CCK-8:DMEM medium = 1:9) was added to each well, and it was incubated at 37 °C for 2 h. The OD value was measured at 450 nm using an enzyme-labeled instrument. The calculation formula of cell proliferation rate is as follows:

[0100]

[0101] wherein OD1 and OD0 represent the absorbance values of the experimental object and the negative control, respectively.

[0102] The test results are shown in Figure 13 (a), and the results show that compared with the control group, each concentration group has no effect on cell activity, with no statistical difference.

[0103] Hemolysis test: New Zealand white rabbits' anticoagulant whole blood was used to evaluate the hemolysis of polyurethane sponge PU, SAPU and the dressing ZAPU prepared in Example 1. Red blood cells were obtained by centrifuging whole blood at 1500 rpm for 15 minutes, then washed in PBS until the supernatant was colorless. 1 mL of red blood cells was added to 9 mL of sterile PBS to prepare a red blood cell suspension. Then, 1 mg of sample was added to 1 mL of diluted blood as the experimental group, and red blood cells were added to deionized water and PBS as positive and negative controls, respectively. After incubation at 37°C for 1 hour, all groups were centrifuged at 2000 rpm for 5 minutes. The absorbance of the supernatant at 540 nm was measured by UV-visible spectrophotometer. The hemolysis ratio (HR) of the dressing sponge was calculated according to the following formula (5).

[0104]

[0105] where OD S represents the absorbance of the dressing, OD (+) represents the absorbance of the positive sample, and OD (-) represents the absorbance of the negative sample. A hemolysis rate of less than 2% is the minimum standard for the clinical application of biomedical materials. The test results are shown in Figure 13 (b). The results show that the extract released from ZAPU prepared in Example 1 has no significant effect on the viability of L929 cells, demonstrating its good biocompatibility. In addition, through live and dead cell staining and hemolysis test, the hemolysis rates of PU and SAPU were 0.21% ± 0.05 and 0.61% ± 0.1, respectively, and the hemolysis rate of ZAPU was 1% ± 0.1%, which verified its safety and met the clinical standards of medical materials.

[0106] To evaluate the bacterial barrier effect of the closed device and its effect on microorganisms, a porcine spike infection (PSI) model was established. Adult male pigs (about 40 kg) with skin structure similar to that of humans were selected as experimental subjects. 4% sevoflurane was used for induction of anesthesia, and 2% sevoflurane and 1% oxygen were used to maintain anesthesia. The hind limbs were shaved, and povidone-iodine, 70% ethanol and sterile bone pins were inserted into the tibia. After the insertion of the bone pins, a suspension of Staphylococcus aureus (ATCC 25923) (1 x 10^8 CFU / mL) was sprayed on the site of the bone pins to simulate contamination. The pigs were randomly assigned to the gauze group and the closed device group (referred to as PINSHIELD), respectively. The clinical symptoms of infection and dressing changes were monitored daily, and the vital signs including body temperature and body weight were recorded every three days. All animal experiments were approved by the animal protection agency and the Qingdao University Use Committee, agreement number QDU-AEC-2024707. The experimental results are shown in Figure 14The wound surface of the closed device group was clean, with only mild redness and no obvious exudation, showing a significant effect in early infection control. By the 14th day, the infection in the gauze group worsened further, with the skin around the nail channel becoming more inflamed, the nail channel mouth significantly increasing, the edge tissue congesting and blackening, and the exudate being thick and pus-like in appearance, indicating that the infection had spread and may have been accompanied by osteomyelitis risk, highlighting the limitations of traditional gauze in nail channel infection prevention and control. In the closed device group, however, there were obvious signs of wound healing, with almost complete resolution of redness and no abnormal exudate from the surrounding tissue, indicating that the infection was effectively controlled. This healing trend highlights the significant advantages of the closed device in nail channel infection prevention and control, showing that it can effectively reduce the incidence of infection complications in clinical applications.

[0107] CT imaging was performed on the nail channel and bone structure of the gauze group and closed device group after the 14th day. Specifically, after the bone nail was removed, the surrounding bone and tissue structure was evaluated using a dual-energy 128-slice CT scanner (GE Healthcare, USA) with the following parameters: 200 mA tube current, alternating tube voltage of 140 kVp and 80 kVp, slice thickness of 5 mm, pixel spacing of 0.625 mm, and DFOV of 20 cm 2 . The average number of scans was 3 repeats. The reconstructed images were analyzed using an aw4.7 workstation (GE) (American Healthcare). Image storage and retrieval were performed through the PACS system. The focus was on evaluating the integrity of the cortex, density changes, and signs of osteomyelitis or abscess formation. The CT imaging images are shown in Figure 15 , and the 14th day imaging and pathological examination further confirmed the significant differences between the two groups. The CT image of the gauze group showed that after the nail was removed, an inflammatory barrier or pseudomembrane was formed in the nail channel, with high-density signals indicating inflammatory calcification deposition. Low-density lesions appeared outside the nail channel, indicating tissue fluid exudation and pus formation, further supporting the diagnosis of osteomyelitis. In addition, low-density signals in the bone marrow cavity around the nail channel and signs of nail loosening indicated that the infection had spread to the deep tissues and may have affected bone stability and the healing process. In contrast, the CT images of the closed device group showed no abnormal signals or inflammation in the bone tissue, the nail channel was clean with no abnormal density signals, the bone marrow tissue density was uniform, and the bone cortex edge was complete. These imaging results indicate that the closed device of the present invention effectively inhibits inflammation and tissue destruction in the prevention and control of nail channel infection.

[0108] MRI measurement signal intensity using t2-weighted was performed to evaluate the soft tissue and medullary cavity of the above-mentioned gauze group and closed device group after 14 days. Specifically, MRI scanning was performed on a 3.0T MRI system (GE MR750, USA) using a multi-channel animal coil. The imaging sequence included t1-weighted (T1WI), t2-weighted (T2WI), and MENSA (multiple echo non-subtraction acquisition) enhancement for the detection of inflammatory areas. The parameters were as follows: TR = 3000 ms, TE = 67.3 ms, FOV = 1 cm x 1 cm, slice thickness = 4 mm, slice interval = 4.5 mm, matrix size = 96 x 128, SAR = 0.875, average = 2. The total imaging time for each sample was approximately 7 minutes and 50 seconds. The images were processed and stored in the PACS system for subsequent analysis, as shown in Figure 16 The MRI scan of the gauze group showed high signal intensity at the site of the nail channel, indicating that the soft tissue infection extended from the medullary cavity, and was accompanied by patchy high signal areas, suggesting residual infection. The inflammatory pseudomembrane and low signal area suggested the presence of gas gangrene. In contrast, the nail channel treated with the PINSHIELD group showed no abnormalities in CT or MRI, the nail channel was clean, the bone marrow density was uniform, and the cortical bone was complete.

[0109] To evaluate the bacterial barrier effect of the closed device and its impact on microorganisms, systemic inflammatory marker exploration was conducted in the pig nail channel infection (PSI) model, including white blood cell and neutrophil count on day 7 and cytokine (IL-6 and IL-1β) level determination. Before dressing change / euthanasia, whole blood samples (10 mL) were collected using a disposable syringe for blood index evaluation. The samples were transported to the laboratory within 2 hours at 4°C using an Icebox for hematology analysis. The results, as shown in Figure 17 The blood test for systemic inflammatory markers showed that the white blood cell count, neutrophil count, and inflammatory factors (IL-6 and IL-1β) of the gauze group were significantly higher than those of the closed device group on day 7, indicating that the gauze group had a significant systemic inflammatory response.

[0110] Histological analysis of gauze and the closed device of the present application was performed using HE (hematoxylin-eosin staining) to evaluate inflammatory cell infiltration and tissue necrosis, including semi-quantitative analysis of bar charts (scale = 1000 μm). The bone nail pericapsular tissue specimens were fixed with tissue fixative (Servicebio, G1101-15ML) for 24 hours and dehydrated with a tissue processor (histore). Paraffin embedding, sectioning (4 μm), and staining were performed. The standard protocol was followed. Hematoxylin and eosin staining was then dehydrated and coated with neutral balsam. The slides were examined using a high-resolution imaging Nikon ECLIPSE CI microscope (Nikon, Japan), and the results are shown in Figure 18HE staining showed that the gauze group had a significant acute inflammatory response around the nail track, with a large number of inflammatory cell infiltration, fibrous tissue hyperplasia and partial tissue necrosis. In contrast, the closed device group showed only a small amount of inflammatory cells, indicating that the infection was well controlled.

[0111] The gauze group and the closed device group of the present application were stained with immunohistochemistry to evaluate the inflammatory response of the nail track. IL-1β is an important cytokine that plays an important role in immune and inflammatory processes. The accompanying semi-quantitative data is represented in a bar graph (scale bar = 1000 μm). To detect IL-1β, the tissue sections were deparaffinized, rehydrated, and antigen extracted in citrate buffer (pH = 6.0). After blocking with serum, the primary antibody IL-1β (Abmart, PK56359M, 1:100) was incubated overnight at 4°C. Then the secondary antibody (Bioss, bs-0295G-HRP, 1:200) was incubated. Then DAB staining (Beyotime Biotechnology, P0203) was performed. After counterstaining with hematoxylin, dehydration and mounting, the microscope was observed under a Nikon ECLIPSE CI (Nikon, Japan), as shown in Figure 19 The IHC staining results of IL-1β showed that the expression of IL-1β in the gauze group was significantly up-regulated around the nail track, especially in the active inflammatory area, with a significant increase in IL-1β positive cells, reflecting a strong immune response. The PINSHIELD group had a lower expression of IL-1β, and the inflammatory response was significantly reduced, indicating that the PINSHIELD group effectively controlled the infection by reducing the expression of inflammatory factors.

[0112] To evaluate the bacterial barrier effect of the closed device and its impact on microorganisms, a pig spike tunnel infection (PSI) model was established. Samples were collected from the pin tunnel wound site of the gauze group and the closed device group on day 7 and day 14. Representative images of bacterial colonies on agar plates and CFU quantification of pin tunnel wound microbial load were explored to compare bacterial growth between PINSHIELD and gauze on day 7 and day 14. Specifically, the tissue sample was chopped and resuspended with 2 mL of PBS, with a mass-volume ratio of 1:10. The mixture was evenly spread on a solid agar plate. After 12-16 h of incubation at 37°C, the bacterial load was determined. Specifically, the truncated pin was fixed in electron microscope fixing solution (Sevier, G1102) and rinsed with phosphate buffer (PB, pH 7.4). After osmium fixation, the dried sample was coated with gold for 240 seconds in a critical point dryer (K850, Quorum) using an ion sputtering device (MC1000, Hitachi) at an acceleration voltage of 15.00 kilovolts. Scanning electron microscopy (JSM-6390LV, Nihon Electronics, Japan) was used to observe biofilm formation, and the results are shown in Figure 20 As shown in the results, the bacterial load of the gauze group was significantly higher than that of the PINSHIELD group. The CFU count results showed that the bacterial load of the gauze group increased significantly, while the bacterial load of the PINSHIELD group remained at a low level, showing a stable bacteriostatic effect. By day 14, the infection in the gauze group was further aggravated, indicating that the infection was worsening, while the bacterial load in the PINSHIELD group remained relatively stable during the entire observation period, effectively inhibiting the progression of the infection.

[0113] Comparing the PINSHIELD group and the gauze group, the bacterial barrier effect of the closed device and its impact on microorganisms were analyzed based on 16S rRNA sequencing. The taxonomic composition of the microbial community at the genus level in the pin tunnel wound on day 14 in the pig spike tunnel infection (PSI) model is shown in Figure 21Microbial level tests such as 16S rRNA sequencing were determined by Qingdao Pishang Biotechnology Co., Ltd., and microbial analysis used CTAB method to extract DNA and library construction. Specifically, DNA was extracted from the tissue around the nail channel using CTAB lysis buffer and lysozyme. After centrifugation, the supernatant was mixed with phenol chloroform isopropanol, followed by chloroform-isopentanol treatment and isopropanol precipitation. The DNA was washed, air-dried and dissolved in ddH2O, and RNase A was added for RNA digestion. PCR amplification was performed using 16S rRNA V4 region to evaluate bacterial diversity. Libraries were constructed using NEBNext Ultra II FS DNA PCR-free Library Prep Kit (New England Biolabs), and sequencing was performed on the NovaSeq 6000 platform. Raw reads were assembled and aligned using FLASH (Version 1.2.11) for quality control and denoising (Magoc et al., 2011) to generate tags. Low-quality reads were filtered using fastp software (Version 0.23.1) (Bokulich et al., 2012) and denoised in QIIME2 (Version 2022) using the DADA2 plugin to obtain high-quality amplicon sequence variants (ASVs). In bacterial taxonomic annotation and phylogenetic tree construction, species annotation was performed in QIIME2 using the Silva138.1 database, and phylogenetic relationships were determined by sequence alignment.

[0114] Figure 22 The pie chart shows the microbial composition at the genus level of the gauze group, highlighting the significant proportion of pathogenic genera, Figure 23 The pie chart shows the microbial composition at the genus level of the PINSHIELD group, showing an increase in beneficial genera and a decrease in pathogenic bacteria. From Figures 21 to 23 As shown, PINSHIELD not only reduces the load of pathogenic bacteria, but also enhances the diversity of beneficial microorganisms. In particular, pathogenic genera such as Staphylococcus and Clostridium have lower abundance in the PINSHIELD group, while health-related genera such as Actinomyces and Porphyromonas are significantly enriched Figures 22 to 23 These results highlight the potential of the PINSHIELD group in restoring microbial community balance and promoting a healthier wound environment.

[0115] Alpha diversity analysis was performed on the above PINSHIELD group and gauze group, as shown in Figure 24As shown, Alpha diversity analysis showed that the diversity of the PINSHIELD group was significantly higher than that of the gauze group, indicating that it had a more stable microbial composition. Figure 25 The Simper analysis highlighted the changes in the relative abundance of pathogenic bacteria and anti-infection genera. The PINSHIELD group significantly reduced the abundance of Staphylococcus aureus and enriched genera with anti-infection ability, such as Porphyromonas and Bacteroides. Figure 26 The T-test analysis showed that the abundance of repair-related genera (such as Desulfovibrio) in the PINSHIELD group-treated wounds was significantly increased, which helped to maintain microbial stability, further confirming the role of the PINSHIELD group in increasing the abundance of repair-related genera, such as Desulfovibrio, further strengthening its role in pathogen control and microbial balance. In summary, these results showed that the PINSHIELD group could promote the establishment of an anti-infection microenvironment by remodeling the wound microbial community.

[0116] Using 16S rRNA sequencing technology, we demonstrated that the PINSHIELD group could regulate the microbial community by reducing pathogenic bacteria (such as Staphylococcus) and increasing probiotics (such as Actinomyces). This remodeling of the microbial community supported the hypothesis that increasing microbial diversity could provide a protective barrier against infection, thereby promoting more efficient wound recovery and reducing complications such as osteomyelitis and delayed healing. The PINSHIELD group could effectively reduce local inflammation, reduce bacterial load, reduce the abundance of Staphylococcus aureus, and increase the diversity and abundance of healthy-related flora.

Claims

1. A method for the preparation of a sealed device filled dressing for use in stapled wounds, characterized by, The closed device for nail track wound comprises two groups of symmetrically arranged shells (1), the tails of the two groups of shells (1) are hinged through a rotating shaft (2), a torsional spring (12) is arranged between the tails of the two groups of shells (1), the inner sides of the heads of the two groups of shells (1) are each provided with a closure piece (3), the two groups of closure pieces (3) are matched with each other, the inner sides of the top portions of the two groups of closure pieces (3) are each provided with a semicircular hole (4) matched with each other, the outer sides of the bottom portions of the two groups of closure pieces (3) are each provided with a skirt (6), and the interiors of the two groups of closure pieces (3) are provided with main and passive collaborative antibacterial dressings; the inner side surface of the head of the shell (1) is in a "C" shape; a plug plate (7) is arranged on the inner side surface of the head of the shell (1), and the closure piece (3) is each provided with a plug groove (8) matched with the plug plate (7); a patch (9) is horizontally arranged on the inner side of the bottom portion of the closure piece (3); a recess (10) is arranged on the inner side wall of the closure piece (3); and the tails of the two groups of shells (1) are each rotationally provided with a handle (11). The antibacterial dressing is prepared by alternately immersing a polyurethane sponge matrix into a zinc ion solution and a sodium alginate solution for short-time crosslinking multiple times through a freeze-drying method. Specifically comprising the following steps: 1) immersing the polyurethane sponge into the sodium alginate solution, standing, and squeezing the residual sodium alginate on the surface of the sponge; 2) immersing into the zinc chloride solution, standing, immersing into the prepared sodium alginate solution again, and standing; 3) repeating step 2), finally immersing into the zinc chloride solution and placing in a shaking bed for reaction, and freeze-drying to obtain the antibacterial dressing; The antibacterial dressing is prepared by alternately immersing a polyurethane sponge matrix into a zinc ion solution and a sodium alginate solution for short-time crosslinking multiple times; In step 2), the time for single immersion into the zinc chloride solution is 10-20 s, the time for single immersion into the sodium alginate solution is 10-20 s, and in step 3), the number of repetitions is 3-6 times; The concentration of the sodium alginate is 0.01-0.02 g / mL, the concentration of the zinc ion is 8-20 mg / mL, in step 3), the shaking bed reaction temperature is 37℃, and the reaction time is 2-6 h.

2. A method of preparing a sealed device filled dressing for use in a stinger wound as claimed in claim 1, wherein, The skirt (6) is downwardly inclined.

3. A method of preparing a sealed device for filling a wound according to claim 1, wherein, In step 1), the standing time is 2-5 min.

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