CN111265364A - Rapid liquid-absorbing expansion hemostasis dressing bag and preparation method and application thereof - Google Patents

Abstract

The invention discloses a rapid liquid absorption expansion hemostasis dressing bag and a preparation method and application thereof. The rapid imbibition expansion hemostasis dressing bag is convenient for on-site treatment personnel to smoothly fill the bleeding site/cavity into the deep part through a narrow wound on the body surface, and the swelling after blood imbibition effectively plays a role in hemostasis by compression. Meanwhile, the hemostatic dressing bag can be integrally removed from the wound, has no scattering and residue, and is easier and more thorough in debridement. The hemostatic dressing bag can be detected by X-ray to prevent residue.

Description

A kind of rapid liquid absorption expansion hemostatic dressing bag and preparation method and application thereof

technical field

The invention relates to the technical field of hemostatic medical devices, in particular to a hemostatic dressing bag and a preparation method and application thereof.

Background technique

Hemorrhage in deep tissue such as penetrating injury or blind tube injury is a sudden accidental injury, especially a high-incidence injury such as gunshot wounds in wartime. This kind of injury is a special type of bleeding that cannot be stopped by conventional tourniquet pressure, and its on-site first aid is still a major part of war trauma treatment so far. problem.

The difficulty of first aid for penetrating wounds or blind canal injuries is mainly due to the inability of emergency personnel to quickly and effectively introduce gauze-like, powder-like or granular hemostatic materials into deep hemorrhages through small wounds on the body surface due to the lack of medical auxiliary resources on the battlefield. Therefore, the hemostatic material cannot really exert its hemostatic activity; in addition, when hemostasis, it is often necessary to insert multiple pieces of gauze into the wound. During debridement, the gauze may not be taken out and left in the wound. In addition, common hemostatic dressings are flat, and they are applied to the wound surface on the body surface during use, and they cannot act on deep bleeding sites, nor can hemostatic dressings truly exert their hemostatic activity.

How to quickly deliver the hemostatic dressing to the deep hemostasis site during the first aid process can gain valuable pre-hospital treatment time and evacuation time for the wounded, and can effectively debride the wound after the hemostasis is completed. .

SUMMARY OF THE INVENTION

In order to solve the above technical problems, the first aspect of the present invention provides a hemostatic dressing bag that can quickly absorb liquid and expand at the wound, comprising a sealed bag body and a hemostatic filler placed in the bag body, the hemostatic filler is selected from the group consisting of: Super absorbent resin, such as one or more of carboxymethylated starch, grafted cellulose, polyacrylate, silk protein, pectin, seaweed, seaweed polysaccharide, chitosan, water-conducting material, etc. The bag body is provided with a developing layer that can be developed under X-rays.

The development layer is arranged on the inner surface and/or outer surface of the bag, or at the seam of the bag body; preferably, the development layer is arranged on the outer surface and/or inner surface of the front and back of the bag body; more Preferably, there are N strips of the developing layer, and N is a positive integer.

The bag body is made of pure cotton fiber, wood pulp fiber, chitosan and its modified materials, polyvinyl alcohol, plant modified starch, sodium polyacrylate resin and other medical hydrophilic materials, non-woven products or biofilms. .

The fabric, non-woven product or biological membrane is a porous structure, and its pore size is smaller than the particle size of the hemostatic filler.

The developing layer contains barium sulfate, a medical developer.

The bag body is a sphere, ellipsoid, cylinder, cuboid or other shapes; preferably, when the bag body is a cuboid, the length × width × height is (5mm-50mm) × (5mm-50mm) × (0.1 mm-10mm); when the bag body is a sphere, the diameter is 5mm-50mm; when the bag body is a cylinder, the diameter of the bottom surface is 5mm-50mm, and the height is (0.1mm-10mm).

The bag body is closed under pressure or closed by sewing.

In the second aspect, the present invention provides a method for preparing the above-mentioned hemostatic dressing bag. After fabrics, non-woven products or biofilms are made into a bag body, a hemostatic filler is loaded, sutured or sealed with high pressure, and finally the bag body is sutured or closed by high pressure. Press the developing layer under high pressure to obtain the quick-absorbing and expanding hemostatic dressing bag;

Preferably, the hemostatic dressing bag is packaged in a vacuum waterproof and easy-to-open plastic package, and sterilized by Co ⁶⁰ irradiation to obtain a hemostatic dressing bag product.

In a third aspect, the present invention provides the application of the above hemostatic dressing bag in the preparation of hemostatic materials for hemostasis in deep wounds; the deep wounds are penetrating wounds and/or blind canal wounds, which may include various firearm wounds, sharps wounds or Deep trauma caused by natural disasters, traffic accidents, etc.

When used for hemostasis in deep wounds, the rapid absorbent and inflatable hemostatic dressing bag is stuffed into the wound; when debridement, the whole of the fast absorbent and inflatable hemostatic dressing bag is removed from the wound; preferably, residual detection can be carried out after removal. , and the imaging layer is detected by X-ray, so as to determine whether the rapid liquid absorption and expansion hemostatic dressing bag is completely removed.

The quick suction and expansion hemostatic dressing bag provided by the invention is small in size, which is convenient for on-site rescue personnel to smoothly pack it into the deep bleeding site or cavity through the narrow wound on the body surface; after blood suction, the dressing bag expands at the deep bleeding site or The pressure is formed inside the cavity, thereby blocking the blood flow and effectively exerting the effect of compression and hemostasis at the bleeding site, so as to avoid the wounded during the evacuation process (the evacuation process is that the wounded is simply treated at the emergency scene and forgets to be referred to the next-level medical institution for referral. In the process of transportation), due to further blood loss and shock, we will strive for rescue time. At the same time, compared with the general powdery hemostatic material, the hemostatic dressing bag of the present invention can be removed from the wound as a whole without scattering or residue, making the debridement easier and more thorough. In addition, the developing layer on the hemostatic dressing bag of the present invention will be developed under X-ray, and whether the hemostatic dressing bag is completely removed can be detected by X-ray to avoid residue. The hemostatic dressing bag of the present invention can be packaged differently according to the size of the wound cavity, is suitable for hemostasis of wound bleeding in deep tissue wounds of different sizes, is convenient to carry and has a long storage stability period.

Description of drawings

Fig. 1 shows the structure schematic diagram of the present invention's quick liquid absorption expansion hemostatic dressing bag before use;

Fig. 2 shows the structural schematic diagram of the present invention's quick suction expansion hemostatic dressing bag after use;

Fig. 3 shows the histogram of the in vitro coagulation time of the rapid suction expansion hemostatic dressing bag of the present invention;

4 is a bar graph showing the influence of the hemostatic filler in the hemostatic dressing bag of the present invention on aPTT and PT;

Figure 5 is a bar graph showing the influence of the hemostatic filler in the hemostatic dressing bag of the present invention on RBC and PLT;

Fig. 6 is a photograph showing the cytotoxicity evaluation of the hemostatic filling in the hemostatic dressing bag of the present invention.

Detailed ways

The content of the present invention is described in more detail below with reference to specific embodiments, and the present invention is further elaborated, but these embodiments are by no means to limit the present invention.

The rapid liquid absorption and expansion hemostatic dressing bag provided by the present invention is a rapid liquid absorption and expansion medical dressing, and its structure is shown in FIG. The outer surface of the body 1 is also provided with a developing layer 3 . in,

The bag body 1 can be made of pure cotton fiber, wood pulp fiber, chitosan and its modified materials, polyvinyl alcohol, plant modified starch, sodium polyacrylate resin or other medical hydrophilic materials, non-woven products or biofilms These materials are all commercially available. The bag body 1 is a sealed bag body, the surface is a porous structure, and the pore size is smaller than the particle size of the hemostatic filler 2.

The hemostatic filler 2 can be a super absorbent resin, such as one or more of carboxymethylated starch, grafted cellulose, polyacrylate, silk protein, pectin, seaweed, seaweed polysaccharide, chitosan, water-conducting material, etc. species, the mixing ratio is not limited;

The developing layer 3 can be directly sewed or stuck on the outer surface of the bag body 1, and N can be set, and N is a positive integer, and the medical developing line barium sulfate line is selected for use.

According to the specific application, the quick-absorbing and expanding hemostatic dressing bag of the present invention can be in the shape of a sphere, ellipsoid, cuboid, cylinder or other shapes before use, and its cross section is (5mm-50mm)×(5mm-50mm)× (0.1-10mm) (the height, that is, the thickness of the double-layer gauze is almost 0). The filling amount of the hemostatic filler 2 is determined according to the swelling property of the material of the hemostatic filler 2 after absorbing water.

The present invention also provides a method for preparing the above-mentioned quick-absorbing and expanding hemostatic dressing bag. The medical fabric, non-woven product or biofilm is cut into two pieces of equal size (5mm-50mm)×(5mm-50mm), and the bags are formed by aligning and sewing. Body 1, filled with 5-50 mg of hemostatic filler 2, sutured and sealed (ie, sealed), finally vacuum-packed, and sterilized by Co ⁶⁰ irradiation. The developing layer 3 can be sewed or pasted on the outer surface of the bag after being sewed and closed, or the bag body can be sewed and closed as a suture, or the developing layer can be sewed or pasted on medical fabrics, non-woven products or biofilms before cutting.

The rapid liquid absorption and expansion hemostatic dressing bag provided by the invention can be used for various unexpected accidents, especially the small wound on the body surface, the large internal wound cavity, the large amount of bleeding, and the inability to be caused by bullet wounds and sharp weapon wounds during wartime. Prehospital emergency tamponade hemostasis for deep tissue trauma with routine compression hemostasis.

When in use, the hemostatic dressing bag of the present invention can be loaded in a large amount (ie a plurality) by the bolus device inside the syringe so as to be quickly and smoothly filled into the wound or directly filled with the fingers with sterile gloves. Figure 2 shows the rapid suction of the present invention. The shape of the inflated hemostatic dressing bag after entering the wound hemostasis and sucking fluid. After use, during debridement, the imaging layer is detected by X-ray to determine whether all the inserted hemostatic dressing bags have been taken out and whether there is any leftover in the wound.

Experiment 1: Hemostatic effect experiment

Instruments and Laboratory Animals

Main instruments: multi-channel physiological monitor MP150, BIOPAC; electronic balance DT-1001A; respiratory anesthesia machine Matrx, MODEL 3000; blood oxygen saturation ECG monitor PM-9000Vet; conventional surgical instruments, anesthetics, Beijing Tonghe Shengtai Institute of Comparative Medicine; Central Venous Catheter, Arrow International Inc.; Thromboelastometry, Haemoscope Corporation; Coagulation Tester ACL 9000, Beckman Coulter, Inc.; Blood Routine Tester XT1800, Sysmex; Arterial Blood Gas Detection Instrument RADIOMETER ABL 800FLEX, Radiometer Medical Equipment (Shanghai) Co., Ltd.

Experimental animals: Guizhou miniature pigs, 18, ♀, 30 ± 5 kg, provided by the Experimental Animal Center of the Military Medical Research Institute of the Chinese People's Liberation Army.

Experimental grouping: randomly divided into 3 groups of 6 heads, including:

Test sample group: the present invention's rapid suction liquid expansion hemostatic dressing bag, sterilized by Co ⁶⁰ irradiation before use;

Positive control group: ^CELOX -ATM;

Negative control group: ordinary sterile medical gauze.

experimental method:

After the experimental animals were anesthetized, they were placed on a constant temperature operating table at 37°C and placed in a supine position; the carotid artery was cannulated, connected to a physiological monitor, and physiological indicators such as blood pressure were monitored;

Modeling of animal hemorrhage model: prepare skin on one side of the groin, make a skin incision of about 5 cm long along the femoral artery on the skin surface, expose the subcutaneous tissue, and find the strongest point of femoral artery pulsation to determine the position of the femoral artery; to be tested Ten minutes after the animal's basal mean arterial pressure (MAP) was stabilized, the femoral artery, femoral vein and surrounding tissues and muscles were vertically cut with 18-gauge surgical scissors to create a model of inguinal hemorrhage;

The blood was sprayed freely for 15 seconds, and the blood volume was collected and weighed with a blank gauze, which was recorded as the basic blood loss to indicate the degree of bleeding; then the hemostatic samples of each group were immediately inserted; observe whether the bleeding was immediately stopped. Observe whether hemostasis is successful; 10 minutes later, simulate activity, internal rotation and abduction 5 times each to check whether hemorrhage; test and observe for 1 hour or until the animal dies.

Statistical indicators

Initial MAP (mmHg), terminal MAP (mmHg), 15s blood loss (g), operation duration (s), subsequent blood loss (g), survival time within 1 hour (min); hemoglobin (HGB, g/L) . Coagulation function indexes: basal values of activated partial thrombin time (aPTT, s) and prothrombin time (PT, s). Data processing and statistics were performed using Microsoft Excel 2013 and GraphPad Prism 5.0 software. Statistical methods include Kruskal-Wallis test, log-rank test, Fisher's exact test. p<0.05 was considered statistically significant. The experimental results are shown in Table 1 and Table 2.

Table 1 Comparison of the basic values of each group

Table 2 Comparison of hemostatic effects

Experimental results

It can be seen from Table 1 that the hematological examination indexes hemoglobin (HGB), coagulation function indexes aPTT and PT of the experimental animals in the three groups before the experiment were all within the normal range, and there was no statistical difference; body weight and initial MAP were basically similar; blood loss before treatment The amount of blood loss in 15 seconds of free spraying is 130.5 ± 29.7 g in the sample group, 132.3 ± 43.4 g in the CELOX-A group (ie the positive control group), and 147.6 ± 29.1 g in the ordinary gauze group (ie the negative control group). g, this may be related to individual differences in animals.

In the process of hemostasis, each animal in the test group did not need manual pressing, while six animals in the ordinary gauze group (ie, the negative control group) required pressing, and five animals in the CELOX-A group required manual pressing 3 minute. The same result can be reflected in the total operation time. The operation time of the test group was 19.0±4.6s, which was significantly better than the 169.0±73.5s of the CELOX-A group and the 187.8±1.7s of the ordinary gauze group (p<0.05). ). Both the CELOX-A group and the test sample group were able to successfully stop bleeding initially, while the normal gauze group as a negative control failed to successfully stop bleeding. During the simulated activity after hemostasis in the minipig inguinal hemorrhage model, neither the CELOX-A group nor the test group had re-bleeding, indicating that the two groups were comparable in terms of hemostasis firmness.

Experiment 2: Research Experiment on Hemostasis Mechanism

Main experimental materials:

aPTT reagent, PT reagent, calcium chloride solution, STEELLEX, Taizhou Zhongqin Shidi; 2.5% Gluta Electron Microscope Special Fixative 100mL (bottle), Beijing Soleibo Science and Technology Co., Ltd.; 4% Paraformaldehyde Fixative 100mL (bottle) , Boster Biotechnology.

Main instruments:

Automatic blood routine tester, Baolingman BM 860; complete blood counter tester MEK 722, Nihon Kohden; semi-automatic coagulation function tester SC 40, Taizhou Zhongqin Shidi Biotechnology Co., Ltd.

1. In vitro coagulation time (CT, clotting time) experiment

In vitro coagulation experiments were carried out in a series of glass vials with the same size and a bottom diameter of 20mm, and 15mg, 25mg, and 50mg of the test material were accurately weighed and placed in the vial; 50mg of chopped standard medical yarn was accurately weighed and placed in the vial as Negative control; empty vials were used as blank controls; 1mL of fresh miniature pig whole blood without anticoagulation was quickly added to these vials, and the vials were poured every 3-5 seconds to observe whether the blood was completely coagulated, and the coagulation time was recorded, in terms of carboxylate. Methylated starch was used as the test material as an example, and the results are shown in Figure 3.

The results in Figure 3 show that the in vitro coagulation time of the test material of the present invention has a good dose correlation, and the coagulation time decreases with the increase of the amount of the material; 50mg of the test material and the negative control gauze (Gauze) under the same mass And the blank control (Blank) significantly shortened the coagulation time, and there was a statistically significant difference p<0.01.

2. Influence of activated partial thrombin time (aPTT) and prothrombin time (PT)

Activated partial thromboplastin time (aPTT) and prothrombin time (PT) are the most commonly used clinical screening tests for intrinsic and extrinsic coagulation systems, respectively.

aPTT test: Take 2 mL of sodium citrate anticoagulated whole blood from miniature pigs, centrifuge at 3000 rpm for 10 min to obtain platelet-poor plasma (PPP), take 200 μL of PPP and add 2 mg of test material, incubate for 2 min, draw 50 μL of the resulting solution and add Mix 50μL of PTT reagent and preheat at 37°C for 3 minutes, add 50μL of calcium chloride for detection, the control does not add the test material, and the rest of the operations are the same. Taking carboxymethylated starch as the test material as an example, the results are shown in Figure 4;

PT test: Take 2 mL of sodium citrate anticoagulated whole blood from miniature pigs, centrifuge at 3000 rpm for 10 min to obtain PPP, take 200 μL of PPP, add 2 mg of test material, incubate for 2 min, draw 50 μL of the resulting solution, preheat at 37°C for 3 min, add 150 μL PT reagent was used for detection, and the test material was not added for the control.

The results in Figure 4 show that there is no significant difference between the porcine platelet-poor plasma added to the test material and the blank control aPTT and PT, indicating that the test material has no effect on the internal and external coagulation pathways. The experimental results show that the test material has no effect on aPTT and PT, and it can be inferred that the procoagulant process of the test material does not depend on the internal and external coagulation pathways.

Since the hemostatic filler in the hemostatic dressing bag of the present invention has no effect on aPTT and PT, it is proved that the hemostatic dressing bag of the present invention also has no effect on aPTT and PT.

3. Effects on RBC and PLT in blood

Add 2 mL of beagle anticoagulated whole blood to a clean glass vial with a diameter of 20 mm at the bottom; then immediately take 0, 0.05 g, 0.1 g, and 0.2 g of the test material accurately weighed in advance and add it (add 0 g of the test material). The test material is the blank control), completely immersed in it (three groups are made in parallel, the whole blood of beagle dogs is collected from three different beagle dogs, and the anticoagulant whole blood taken from the same beagle dog is used in each group), After soaking for 1h, completely absorb the remaining liquid and quantify it. After aspirating the remaining liquid, add 2 mL of normal saline to the samples other than the blank control, shake gently, and aspirate it for quantitative inspection after 30s. Count the above samples with a complete blood counter MEK722: adjust the equipment to the Beagle dog cell counting mode, take 20 microliters of dilution measurement method, and add samples separately for measurement; RBC and PLT not adsorbed on the test material = 1h Then draw the remaining liquid × the concentration of the corresponding test component + the washing volume of normal saline × the concentration of the corresponding test component; the number of blank control RBC and PLT = the corresponding measured concentration × 2mL; therefore, the number of RBC and PLT adsorbed on the test material = the number of blank control - The amount not adsorbed on the test material, taking carboxymethylated starch as the test material as an example, the results are shown in Figure 5.

As can be seen from Figure 5, after 1h, the remaining liquid is absorbed, and the remaining liquid in 0.05g is 1.5±0.1mL (n=3); the remaining liquid in 0.1g is about 1.1±0.1mL (n=3); the remaining liquid in 0.2g is about 0.7 ±0.1mL (n=3); the original blood volume is 2mL, and the percentages of blood absorbed by 0.05g, 0.1g, and 0.2g of the test material are calculated to be 25%, 45%, and 65%, respectively, in a dose-increasing relationship. It shows that the tested material has a strong ability to absorb the liquid in the blood, so as to rapidly concentrate the local coagulation factors.

Since the hemostatic filler in the hemostatic dressing bag of the present invention has a strong ability to absorb liquid in blood, it is proved that the hemostatic dressing bag of the present invention also has a strong ability to absorb liquid in blood.

Experiment 3: Safety Evaluation Experiment

Main experimental materials:

2X RPMI 1640 medium, 1X RPMI 1640 medium, Maichen Technology; D-Hanks solution 500mL (bottle), Solarbio; Fetal bovine serum, Sijiqing Zhejiang Tianhang Biotechnology Co., Ltd.; SDH staining solution (succinic acid dehydration) Hydrogenase staining solution) 50mL, Solarbio company; Microplate reader (Elx 800), BIO-TEK.

experimental method

1. Cytotoxicity evaluation

Membrane diffusion method: according to GB/T 16886.5-2003/ISO 10993-5:1999 (8.4.2)

①Sample preparation: irradiate the test material with cobalt source (radiation dose 30kGy), put it into a glass container with a stopper, add an appropriate amount of culture medium, and make the material fully absorb liquid for use.

②Preparation of cell suspension:

Take the vigorously growing L929 cells cultured for 3 to 5 days, remove the culture medium, wash twice with D-Hanks solution, remove the D-Hanks solution, add an appropriate amount of 0.25% trypsin for 1 min, remove the trypsin solution, and add an appropriate amount of Growth medium is gently pipetted to make a cell suspension. The number of cells was counted, and the number of viable cells was counted, and the cell concentration was adjusted so that the number of cells reached 2.5×10 ⁵ mL ^-1 .

的培养皿内，放置一张经充分水化，121℃高压蒸汽灭菌的孔径0.45μm的微孔滤膜，共设5皿。4皿加入上述细胞悬液8mL，另1皿加入8mL 无细胞的培养基做空白对照。置于37℃、5％CO₂培育箱，培育24h，使细胞在滤膜上 生长成单层。③ in sterile

In the petri dish, place a microporous filter membrane with a pore size of 0.45 μm that has been fully hydrated and sterilized by high pressure steam at 121 °C, and a total of 5 dishes are set. 8 mL of the above cell suspension was added to 4 dishes, and 8 mL of cell-free medium was added to the other 1 dish as a blank control. Placed in a 37°C, 5% CO ₂ incubator for 24 h to allow cells to grow into a monolayer on the filter.

④ Nutrient agar preparation and cell filter transfer

Agar preparation: 3% agar, 0.75g agar powder, dilute to a volume of 25mL, and sterilize by autoclaving at 121°C.

的培育皿内，每皿5mL， 室温固化。Preparation of nutrient agar medium: mix equal amounts of 3% agar solution (about 48°C) with fresh 2×RPMI 1640 (containing 20% fetal bovine serum) medium, and pour into sterile

5 mL per dish, solidified at room temperature.

Remove the filter with the monolayer of cells, wash twice with D-Hanks solution, and place the filter on the nutrient agar medium with the cells facing down so that the cells stick to the surface of the nutrient agar medium.

⑤ Sample placement: place on the surface of the filter membrane

A. 3 test material clumps with the medium fully moistened, and at the same time place a filter paper sheet (negative) with a diameter of 5mm soaked in the saturated medium, 2 dishes of the test group;

B. 1 dish with cells, and no sample is placed as a negative control group;

C. 1 dish has cells, place 4 filter paper sheets saturated with 20% phenol with a diameter of 5mm, the positive control group;

D. 1 dish has no cells, as a blank control group for test, negative and positive;

Placed in a 37°C 5% _CO2 incubator for 2h.

⑥ Take out the filter membrane, wash it twice with D-Hanks solution, put the filter membrane in SDH staining solution, stain in the dark, incubate in the incubator for 3h, wash with deionized water, and air dry. Finally, the coloring situation of the filter membrane and its surrounding and the size of the decolorized area around the filter membrane were observed with the naked eye and microscope; the staining situation and cell morphology of the cells on the filter membrane were observed with the microscope. The evaluation and classification were carried out according to the evaluation criteria in Table 3, and the carboxymethylated starch was used as the test material as an example. The results are shown in Figure 6.

Table 3 The relationship between the experimental results of the filter diffusion method and the cytotoxicity classification

的脱色区。Visual observation results: There is no decolorization area around the negative control sample in the test sample dish, and the filter membranes of the two dishes of the test material group are dyed blue, and blue stripes appear that are consistent with the size of the sample, as shown in Figure 6, in which the left The side shows the position of the sample, and the right side shows the situation after staining with SDH staining solution; under and around the positive control sample

decolorization area.

Microscopic observation results: The cells on the filter membrane of the test material are in normal shape, and the cells are stained blue; the negative control filter membrane is stained blue, and the cell morphology on the filter membrane is similar to that of the sample. The cells under and around the positive control sample were not stained, the nucleus was unclear, and most of the cells were lysed. The blank control filter without cells is not stained.

According to the evaluation grading, the positive result is grade 4, which meets the requirements, indicating that the experimental result is reliable; the test result of the sample is grade 1, indicating that the cytotoxicity of the test material is slight. Since the cytotoxicity of the hemostatic filler in the hemostatic dressing bag of the present invention is slight, it is proved that the cytotoxicity of the hemostatic dressing bag of the present invention is also slight.

2. Hemolysis test:

Extracted samples: extract the volume of normal saline at 37°C for 24 hours according to the maximum saline absorption rate of the tested material + 0.1 g·mL ^-1 ;

Take fresh 3.8% sodium citrate anticoagulated rabbit whole blood (1:9), add 60 μL of anticoagulated rabbit whole blood to 3 mL of leaching solution; if negative, add 60 μL of anticoagulated rabbit whole blood to 3 mL of normal saline; positive control Add 60 μL of anticoagulated rabbit whole blood to 3 mL of deionized water; incubate at 37°C for 1 hour; centrifuge at 2000 r·min ^-1 for 5 min, take 200 μL of supernatant and add it to a 96-well plate, 8 wells for each sample, with a wavelength of 545 nm under a microplate reader Detect OD value;

The calculation formula of hemolysis rate is: hemolysis rate%=(sample-negative)OD/(positive-negative)OD×100%. Taking carboxymethylated starch as the test material as an example, the results are shown in Table 4.

Table 4 Hemolysis rate of tested materials

The results in Table 4 show that the hemolysis rate of the tested material was 0.61%, which was significantly less than the critical standard level of 5%, indicating that the material did not undergo significant hemolysis. Since the hemostatic filler in the hemostatic dressing bag of the present invention does not have an obvious hemolytic reaction, it is proved that the hemostatic dressing bag of the present invention also does not have an obvious hemolytic reaction.

The advantage of the present invention is that the water-absorbing and swellable material is wrapped in a good water-permeable material to make small bags, the volume and size of which can enable the operator to smoothly pass through the narrow body surface wound and pack it into the deep wound. And touch the bleeding site, and rely on the good water absorption and swelling properties of the internal material to achieve the effect of quickly filling the wound and compressing the hemostasis. Disadvantages such as thrombosis. It is especially suitable for rapid first aid and hemostasis at the scene of massive bleeding that cannot be effectively filled by hemostatic dressings such as penetrating injuries caused by various firearm injuries or natural disasters, traffic accidents, and blind tube injuries, preventing the occurrence of hemorrhagic shock, and providing the next step for hospital evacuation and treatment. Treatment buys valuable rescue time. It has the advantages of rapid hemostasis, easy portability and long storage time.

The above are only the preferred embodiments of the present invention. It should be noted that, for those skilled in the art, without departing from the principles of the present invention, several improvements and modifications can be made. These improvements and Retouching should also be considered as part of the present invention.

Claims (10)

1. a quick liquid absorption expansion hemostatic dressing bag, is characterized in that, comprises the bag body of sealing and the hemostatic filler that is placed in the bag body, and described hemostatic filler is selected from super absorbent resin, such as carboxymethylated starch, One or more of grafted cellulose, polyacrylate, silk protein, pectin, seaweed, seaweed polysaccharide, chitosan, water-conducting material, etc. developing layer. 2. The rapid liquid absorption and expansion hemostatic dressing bag according to claim 1, wherein the developing layer is provided on the inner surface and/or the outer surface of the bag, or at the seam of the bag body; preferably, the developing layer is It is arranged on the outer surface and/or the inner surface of the front and back of the bag body; more preferably, the developing layer is provided with N strips, and N is a positive integer. 3. according to claim 1 or 2 described rapid liquid absorption expansion hemostatic dressing bag, it is characterized in that, described bag body is pure cotton fiber, wood pulp fiber, chitosan and its modified material, polyvinyl alcohol, vegetable modified material. Fabrics, non-woven products or biofilms of medical hydrophilic materials such as synthetic starch and sodium polyacrylate resin. 4. according to any one of claim 1-3 described rapid liquid absorption expansion hemostatic dressing bag, it is characterized in that, described fabric, non-woven product or biofilm are porous structure, and its aperture is smaller than the particle diameter of described hemostatic filler . 5 . The rapid liquid absorption and expansion hemostatic dressing bag according to claim 1 , wherein the developing layer contains a medical developer, barium sulfate. 6 . 6. According to any one of claims 1-5, the bag body is characterized in that the bag body is a sphere, an ellipsoid, a cylinder, a cuboid or other shapes; preferably, the bag body When it is a rectangular parallelepiped, the length × width × height is (5mm-50mm) × (5mm-50mm) × (0.1mm-10mm); when the bag body is a sphere, the diameter is 5mm-50mm; the bag body is a cylinder When the body is used, the diameter of the bottom surface is 5mm-50mm, and the height is (0.1mm-10mm). 7 . The rapid liquid absorption and expansion hemostatic dressing bag according to any one of claims 1 to 6 , wherein the bag body is sealed by pressure or sutured. 8 . 8. A method for preparing a hemostatic dressing bag described in any one of claims 1-7, characterized in that, after fabrics, non-woven products or biofilms are made into the bag body, hemostatic fillers are loaded, and the bag is sutured. or high-pressure sealing, and finally sewing or high-pressure pressing the developing layer on the bag body to obtain the rapid liquid absorption and expansion hemostatic dressing bag; Preferably, the hemostatic dressing bag is packaged in a vacuum waterproof and easy-to-open plastic package, and sterilized by Co ⁶⁰ irradiation to obtain a hemostatic dressing bag product. 9. The application of any one of claims 1-7 in the preparation of hemostatic material for deep wound hemostasis; the deep wound is a penetrating wound and/or a blind canal wound, which can include various Deep trauma caused by gunshot wounds, sharps injuries or natural disasters, traffic accidents, etc. 10. The application according to claim 9, characterized in that, when used for hemostasis in deep wounds, the rapid liquid absorption and expansion hemostatic dressing bag is stuffed into the wound; when debridement, the whole of the rapid liquid absorption and expansion hemostatic dressing bag is used for debridement. It is removed from the wound; preferably, after removal, residual detection can be performed, and the imaging layer can be detected by X-ray to determine whether the rapid suction expansion hemostatic dressing bag is completely removed.

Images