Hemostatic composite fibers and methods of making the same

Abstract

Some embodiments of the present disclosure provide a hemostatic composite fiber and a method of manufacturing the same. The hemostatic composite fiber includes a plurality of molecular sieve rayon fibers and a plurality of chitosan fibers, the chitosan fibers being interlaced between the molecular sieve rayon fibers. The plurality of molecular sieve rayon fibers includes a plurality of rayon fibers and a plurality of molecular sieves, the molecular sieves being distributed on the surfaces of the rayon fibers. Some embodiments of the present disclosure also provide a method of manufacturing the hemostatic composite fiber. Via complementary hemostatic pathways of the molecular sieves and the chitosan, and direct preparation of the hemostatic materials (the molecular sieves and the chitosan) as a part of the fiber, the hemostatic effect is improved, and the effective duration is prolonged.

Description

Technical Field

[0001] This disclosure pertains to hemostatic composite fibers and their manufacturing methods. Background Technology

[0002] Currently available commercially available hemostatic gauze mainly involves coating gauze with a hemostatic agent (such as kaolin), allowing it to act on the wound and achieve hemostasis. However, gauze prepared using this method often suffers from insufficient adhesion of the hemostatic agent, making it prone to detachment and resulting in inconsistent hemostatic efficacy. Furthermore, some types of hemostatic agents release heat after absorbing blood; if the amount and type of agent added are not properly controlled, it may actually cause burns to the wound.

[0003] Therefore, the problem to be solved is how to provide hemostatic composite fibers that are both safe and have good hemostatic efficacy. Summary of the Invention

[0004] This disclosure provides a hemostatic composite fiber comprising multiple molecular sieve rayon fibers and multiple chitosan fibers, the chitosan fibers being interleaved among the molecular sieve rayon fibers. The molecular sieve rayon fibers comprise multiple rayon fibers and multiple molecular sieves distributed on the surface of the rayon fibers.

[0005] In some embodiments, the molecular sieve is an aluminosilicate hydrate.

[0006] In some embodiments, the aluminosilicate hydrate contains Na 12 [(AlO2) 12 (SiO2) 12 ]·xH2O.

[0007] In some embodiments, the weight ratio of rayon fiber to molecular sieve is 1:20 to 20:1.

[0008] In some embodiments, the weight ratio of molecular sieve rayon fibers to chitosan fibers is 1:10 to 10:1.

[0009] In some embodiments, the weight percentage of the hemostatic composite fiber is 100%, the weight percentage of the molecular sieve is 5% to 50%, and the weight percentage of the chitosan fiber is 10% to 90%.

[0010] This disclosure provides a method for manufacturing hemostatic composite fibers, comprising: mixing molecular sieve synthetic materials, rayon, and water to obtain a molecular sieve rayon fiber synthetic solution; heating the molecular sieve rayon fiber synthetic solution to obtain a plurality of molecular sieve rayon fibers, wherein the molecular sieve rayon fibers comprise a plurality of rayon fibers and a plurality of molecular sieves distributed on the surface of the rayon fibers; providing a plurality of chitosan fibers; and interweaving the molecular sieve rayon fibers and the chitosan fibers to obtain hemostatic composite fibers.

[0011] In some embodiments, the molecular sieve synthesis material includes sodium oxide, alumina, and silicon oxide.

[0012] In some embodiments, when the molecular sieve rayon fiber synthesis solution is 100% by weight, the total weight percentage of sodium oxide, alumina, and silicon oxide is 5% to 15%, and the weight percentage of rayon is 1% to 10%.

[0013] In some embodiments, in the step of interweaving the molecular sieve rayon fibers and the chitosan fibers, the weight ratio of the molecular sieve rayon fibers to the chitosan fibers is 1:10 to 10:1. Attached Figure Description

[0014] The various aspects of this disclosure can be best understood from the following detailed description when read in conjunction with the accompanying drawings. It should be noted that, in accordance with standard industrial methods, the various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or decreased for clarity of discussion.

[0015] Figure 1 A flowchart illustrating the method for manufacturing hemostatic composite fibers;

[0016] Figure 2A as well as Figure 2B Electron microscope images of molecular sieve rayon fibers are presented, among which... Figure 2A , Figure 2B It has a high magnification.

[0017] Figure 3 This chart presents a statistical comparison of the standardized content of dissolved blood in each group of test samples during the hemostatic effect test.

[0018] [Symbol Explanation]

[0019] 100: Method

[0020] 200, 300: Electron microscope images

[0021] 400: Integration and Comparison Chart

[0022] S110, S120, S130, S140: Steps Detailed Implementation

[0023] To achieve the different features of the mentioned subject matter, the following disclosure provides many different implementations. Specific examples of components, values, materials, configurations, etc., are described below to simplify this disclosure. Of course, these are merely examples and not limiting. For example, in the following description, forming a first feature on or above a second feature can include implementations where the first and second features are formed in direct contact, and can also include implementations where an additional feature is formed between the first and second features such that the first and second features do not need to be in direct contact. Furthermore, reference numerals and / or letters may be repeated in various examples in this disclosure. This repetition is for simplicity and clarity and does not in itself imply a relationship between the various implementations and / or configurations discussed.

[0024] This disclosure provides a hemostatic composite fiber and its manufacturing method. By selecting molecular sieves and chitosan as hemostatic materials, molecular sieve rayon fibers and chitosan fibers are prepared in an interleaved manner. Therefore, the hemostatic composite fiber possesses the rapid water absorption and thrombosis-inducing mechanism of molecular sieves (secondary hemostasis), and the attraction of red blood cells and platelets to aggregation and coagulation mechanism of chitosan (primary hemostasis). Through these complementary hemostatic pathways, the hemostatic effect is enhanced. Furthermore, by preparing the hemostatic material directly as part of the fiber, rather than coating it onto the fiber, the probability of coating detachment can be reduced, and the original hemostatic efficacy cannot be inhibited by covering the fiber surface with hemostatic properties. This ensures that the hemostatic efficacy is maximized and its duration of effectiveness is prolonged.

[0025] Please refer to Figure 1 The diagram illustrates a method 100 for manufacturing hemostatic composite fibers, comprising steps S110 to S140.

[0026] Step S110 involves mixing molecular sieve synthesis materials, rayon, and water to obtain a molecular sieve rayon fiber synthesis solution.

[0027] In some embodiments, the molecular sieve synthesis material comprises sodium oxide (e.g., Na₂O), alumina (e.g., Al₂O₃), and silicon oxide (e.g., SiO₂). In some embodiments, when the weight percentage of the molecular sieve rayon fiber synthesis solution is 100%, the total weight percentage of sodium oxide, alumina, and silicon oxide is 5% to 15% (e.g., 5%, 10%, 15%, or values ​​within the aforementioned range), and the weight percentage of rayon is 1% to 10% (e.g., 1%, 2.5%, 5%, 7.5%, 10%, or values ​​within the aforementioned range). If the total weight percentage of sodium oxide, alumina, and silicon oxide is too high or too low, the synthesis efficiency of the molecular sieve decreases.

[0028] Step S120 involves heating the molecular sieve rayon fiber synthesis liquid to obtain multiple molecular sieve rayon fibers, wherein these molecular sieve rayon fibers comprise multiple rayon fibers and multiple molecular sieves distributed on the surface of these rayon fibers, wherein the molecular sieves are attached to the surface of the rayon fibers in a non-covalent bond manner.

[0029] In some embodiments, the molecular sieve is an aluminosilicate hydrate, such as 4A molecular sieve (Na₂O₃), which has a simpler synthesis procedure compared to other types of molecular sieves. 12 [(AlO2) 12 (SiO2) 12 ]·xH2O), where 4A represents the particle size of the molecular sieve is approximately In some embodiments, the rayon fibers extend in a columnar shape, while the molecular sieves are distributed in a granular form on the surface of the rayon fibers.

[0030] In some embodiments, the weight ratio of rayon fiber to molecular sieve is 1:20 to 20:1, for example, 1:20, 1:15, 1:10, 1:5, 1:1, 5:1, 10:1, 15:1, 20:1, or values ​​within the aforementioned range. If the weight ratio is too high, there will be insufficient molecular sieve, limiting the hemostatic effect; if the weight ratio is too low, there will be an excess of molecular sieve, but the hemostatic effect has already reached saturation, resulting in excessive consumption of raw materials.

[0031] In some embodiments, the molecular sieve rayon fiber synthesis solution is heated at 80°C to 95°C (e.g., 80°C, 85°C, 90°C, 95°C, or values ​​within the aforementioned range) for 12 to 24 hours (e.g., 12 hours, 15 hours, 18 hours, 21 hours, 24 hours, or values ​​within the aforementioned range) until the molecular sieve and rayon fiber are synthesized. If the temperature is too low or the time is too short, the synthesis efficiency of the molecular sieve and rayon fiber is limited; if the temperature is too high or the time is too long, the risk of rayon fiber denaturation increases.

[0032] Step S130 is to provide a plurality of chitosan fibers.

[0033] In some embodiments, chitosan fibers can be obtained by wet spinning using chitosan as a raw material. In some embodiments, the chitosan fibers can be soaked in an acidic solution for 15 to 45 minutes, causing the amino groups (-NH2) in the chitosan to convert into positively charged amino groups (-NH3+), thereby enhancing their attraction to negatively charged red blood cells and platelets, and thus improving the agglutination effect. In some embodiments, the acidic solution contains 1% to 10% by weight of an acidic solute (e.g., 1%, 3%, 5%, 7%, 9%, 10% or values ​​within the aforementioned range), wherein the acidic solute includes acetic acid, lactic acid, citric acid, succinic acid, glycolic acid, or combinations thereof.

[0034] Step S140 involves interweaving these molecular sieve rayon fibers and these chitosan fibers to obtain hemostatic composite fibers.

[0035] In some embodiments, the weight ratio of these molecular sieve rayon fibers to these chitosan fibers is from 1:10 to 10:1, for example, 1:10, 1:7.5, 1:5, 1:2.5, 1:1, 2.5:1, 5:1, 7.5:1, 10:1, or values ​​within the aforementioned range. In one embodiment, a weight ratio of 1:1, compared to other weight ratios from 1:10 to 10:1, can achieve better coagulation performance.

[0036] In some embodiments, when the weight percentage of the hemostatic composite fiber is 100%, the weight percentage of the molecular sieve is 5% to 50% (e.g., 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, or values ​​within the aforementioned ranges), and the weight percentage of the chitosan fiber is 10% to 90% (e.g., 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or values ​​within the aforementioned ranges). If the weight percentage of the molecular sieve or the weight percentage of the chitosan fiber is too low, the coagulation efficiency is limited; if the weight percentage of the molecular sieve or the weight percentage of the chitosan fiber is too high, the hemostatic effect may have reached saturation, resulting in excessive consumption of raw materials.

[0037] The hemostatic composite fiber prepared by method 100 comprises molecular sieve rayon fibers and chitosan fibers. The molecular sieve and chitosan can induce two different coagulation mechanisms (molecular sieve: secondary coagulation, and chitosan: primary coagulation), which complement each other to achieve better hemostatic efficacy. Furthermore, it does not generate a large amount of heat when absorbing water. Compared to kaolin, using molecular sieves and chitosan can also reduce the risk of burns. In addition, compared to coating the surface of one fiber with either molecular sieve or chitosan, the design of alternating distribution of molecular sieve rayon fibers and chitosan fibers not only reduces the possibility of chitosan detachment due to insufficient adhesion but also ensures that both coagulation mechanisms are induced, preventing the coating of one fiber from inhibiting the coagulation efficacy of the coated fiber itself.

[0038] In the following description, several embodiments of the present disclosure will be listed to conduct various analyses to verify the effectiveness of the present disclosure.

[0039] Example 1, Preparation Method

[0040] 1. Preparation of molecular sieve rayon fibers

[0041] A molecular sieve rayon fiber synthesis solution was obtained by mixing molecular sieve synthesis materials (Na2O, Al2O3, SiO2), rayon, and water, wherein the molar ratio of Na2O:Al2O3:Al2O3:water was 10:1:9:200, and the weight ratio of rayon to the molecular sieve rayon fiber synthesis solution was 1:20.

[0042] Next, the molecular sieve rayon fiber synthesis solution was heated at 90°C for 24 hours to synthesize molecular sieve rayon fibers. During the process, the molecular sieve rayon fiber synthesis solution gradually became clear as the molecular sieve was synthesized. The weight ratio of rayon fiber to molecular sieve in the molecular sieve rayon fiber was approximately 2:1 to 1:1.

[0043] Please refer to Figure 2A as well as Figure 2B These are electron microscope images of molecular sieve rayon fibers, shown in figures 200 and 300, where relative to... Figure 2A , Figure 2B It has a high magnification. Figure 2A as well as Figure 2B Particulate molecular sieves are visible distributed on the surface of columnar extended rayon fibers.

[0044] It should be noted that, in this preparation process, considering the simplicity of synthesis, the 4A molecular sieve {Na} was chosen for synthesis. 12 [(AlO2) 12 (SiO2) 12]·xH2O}. However, this disclosure is not limited to this, and other types of molecular sieves that can induce secondary coagulation reactions may be selected based on other needs.

[0045] 2. Preparation of chitosan fibers

[0046] Chitosan fibers are prepared using a wet spinning process. Next, the chitosan fibers are immersed in an acidic solution (containing 3% to 5% by weight of a weak acid in an alcoholic solution) for approximately 30 minutes, allowing the amino groups in the chitosan fibers to convert into positively charged ammonium groups, thereby enhancing the aggregation effect on negatively charged red blood cells and platelets. Excess acidic solution is then removed by rinsing with alcohol.

[0047] It is understood that the aforementioned weak acids include, for example, acetic acid, lactic acid, citric acid, succinic acid, or glycolic acid. Any weak acid that can achieve the aforementioned effects should be included within the scope of this disclosure.

[0048] 3. Preparation of hemostatic composite fibers

[0049] The molecular sieve rayon fibers obtained in step 1 and the chitosan fibers obtained in step 2 are interwoven and spun into nonwoven fabrics at specific weight ratios (e.g., 100:0, 90:10, 70:30, 50:50, 30:70, 10:90, and 0:100 used in subsequent tests) to obtain hemostatic composite fibers with different proportions of molecular sieve rayon fibers and chitosan fibers. Therefore, the rayon fibers and chitosan fibers in the hemostatic composite fibers are interwoven and interspersed.

[0050] Example 2: Hemostatic Effect Test

[0051] 100 microliters of blood were dripped onto a commercially available gauze pad (purchased from YASCO) and a commercially available hemostatic gauze pad (…). The hemostatic material was kaolin and hemostatic composite fibers (experimental group) with different weight ratios of molecular sieve rayon fibers and chitosan fibers, and waited for 30 seconds.

[0052] Next, the test samples with adsorbed blood were immersed in 10 ml of physiological saline solution and shaken for 120 seconds to dissolve the adsorbed blood. Then, the absorbance of the blood extract for each group of test samples was measured at 540 nm.

[0053] To further analyze the relationship between absorbance and the blood (dissolved blood) content in the blood leachate, a mixture of 100 μL of blood and 10 mL of physiological saline was used as the standard sample, and the absorbance at 540 nm of the standard sample was defined as 1. The absorbance of each group's blood leachate was then compared with the absorbance of the standard sample to obtain the relative absorbance of each group's blood leachate. Next, the relative absorbance of the blood leachate from the commercially available gauze pad group was taken as 1, serving as the basis for standardizing the dissolved blood content. A comparative chart 400 showing the standardized content of dissolved blood in each group was generated, and the results were summarized in [the table / document / etc.]. Figure 3 In other words, the higher the standardized content, the higher the corresponding dissolved blood content, and consequently, the worse the hemostatic effect.

[0054] Figure 3 The results showed that, compared to commercially available gauze pads and commercially available hemostatic gauze (using kaolin as the hemostatic material), the experimental groups containing molecular sieves or chitosan exhibited better coagulation efficacy. Molecular sieves can induce secondary coagulation, rapid water absorption, and thrombus formation; chitosan can induce primary coagulation, attracting red blood cells and platelets to aggregate. Furthermore, unlike commercially available hemostatic gauze (using kaolin as the hemostatic material) which showed significant exothermic reaction upon water absorption, the experimental groups did not exhibit significant exothermic reaction, thus demonstrating better safety when applied to wounds.

[0055] Furthermore, compared to 100% molecular sieve rayon fiber or 100% chitosan fiber, in the experimental groups with different weight percentages of molecular sieve rayon fiber and chitosan fiber, the groups with 90% molecular sieve rayon fiber + 10% chitosan fiber, 50% molecular sieve rayon fiber + 50% chitosan fiber, 30% molecular sieve rayon fiber + 70% chitosan fiber, and 10% molecular sieve rayon fiber + 90% chitosan fiber all exhibited better coagulation efficacy.

[0056] It was also observed that the 50% molecular sieve leyne fiber + 50% chitosan fiber group exhibited better coagulation efficacy in several experimental groups with different weight percentages. Since there is no specific correlation between the weight percentage changes of molecular sieve leyne fiber and chitosan fiber and coagulation efficacy, the better coagulation efficacy achieved by the 50% molecular sieve leyne fiber + 50% chitosan fiber group was unexpected.

[0057] The foregoing outlines some features of the embodiments to enable those skilled in the art to better understand the viewpoints of this disclosure. Those skilled in the art should understand that they can readily use this disclosure as a basis for designing or modifying other processes and structures to achieve the same purpose and / or the same advantages as the embodiments described herein. Those skilled in the art should also understand that such equivalent constructions do not depart from the spirit and scope of this disclosure, and that various changes, substitutions, and modifications can be made without departing from the spirit and scope of this disclosure.

Claims

1. A hemostatic composite fiber, characterized in that, Include: Multiple molecular sieve rayon fibers, including: Multiple rayon fibers; and Multiple molecular sieves are distributed on the surface of the multiple rayon fibers; and Multiple chitosan fibers are interspersed among the multiple molecular sieve rayon fibers.

2. The hemostatic composite fiber as described in claim 1, characterized in that, The plurality of molecular sieves therein are aluminosilicate hydrates.

3. The hemostatic composite fiber as described in claim 2, characterized in that, The aluminosilicate hydrate contains Na. 12 [(AlO2) 12 (SiO2) 12 ]·xH2O.

4. The hemostatic composite fiber as described in claim 1, characterized in that, The weight ratio of the plurality of rayon fibers to the plurality of molecular sieves is 1:20 to 20:

1.

5. The hemostatic composite fiber as described in claim 1, characterized in that, The weight ratio of the plurality of molecular sieve rayon fibers to the plurality of chitosan fibers is 1:10 to 10:

1.

6. The hemostatic composite fiber as described in claim 1, characterized in that, Wherein, when the weight percentage of the hemostatic composite fiber is 100%, the weight percentage of the plurality of molecular sieves is 5% to 50%, and the weight percentage of the plurality of chitosan fibers is 10% to 90%.

7. A method for manufacturing hemostatic composite fibers, characterized in that, Include: Molecular sieve synthesis material, rayon, and water are mixed to obtain molecular sieve rayon fiber synthesis solution; The molecular sieve rayon fiber synthesis solution is heated to obtain a plurality of molecular sieve rayon fibers, wherein the plurality of molecular sieve rayon fibers comprises a plurality of rayon fibers and a plurality of molecular sieves distributed on the surface of the plurality of rayon fibers; Provides multiple chitosan fibers; as well as The plurality of molecular sieve rayon fibers and the plurality of chitosan fibers are interwoven and spun together to obtain hemostatic composite fibers.

8. The method for manufacturing hemostatic composite fibers as described in claim 7, characterized in that, The molecular sieve synthesis material includes sodium oxide, aluminum oxide, and silicon oxide.

9. The method for manufacturing hemostatic composite fibers as described in claim 8, characterized in that, When the molecular sieve rayon fiber synthesis solution is calculated as 100% by weight, the total weight percentage of sodium oxide, alumina, and silicon oxide is 5% to 15%, and the weight percentage of rayon is 1% to 10%.

10. The method for manufacturing hemostatic composite fibers as described in claim 7, characterized in that, In the step of interweaving the plurality of molecular sieve rayon fibers and the plurality of chitosan fibers, the weight ratio of the plurality of molecular sieve rayon fibers to the plurality of chitosan fibers is 1:10 to 10:1.

Images