Wound dressing with hemostasis function

Abstract

The invention discloses a wound dressing with a hemostatic function, which is characterized in that a gel fiber fabric with hydrophilicity and a porous structure is used as a base material, and hemostatic drugs are distributed in surface micropores or internal pore spaces of the gel fiber base material through surface smearing or soaking loading; the gel fiber fabric is prepared from one or more of acylated chitosan fiber, carboxymethyl chitosan fiber, carboxymethyl cellulose (CMC) fiber, carboxyethyl cellulose fiber, alginate fiber and hydrophilic formalized polyvinyl alcohol fiber; the hemostatic drug is tranexamic acid or a derivative thereof, thrombin, chitosan or fibrinogen in an internal pore space. By utilizing the hygroscopicity of the gel fiber dressing and the softness of the wet gel, the hemostatic medicine is effectively sent to each part of the wound surface, so that the aim of effectively stopping bleeding on the complex wound surface is fulfilled.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of biological medicine, in particular to a wound dressing with hemostatic function. BACKGROUND

[0002] In the field of surgery and trauma, hemostatic drugs are the core means to control bleeding, mainly including two categories of water-soluble powder / solid (such as tranexamic acid powder) and liquid (such as thrombin solution). However, when facing irregular tissue laceration or dynamic movement site bleeding, the direct application of the above-mentioned form of hemostatic drugs has significant clinical limitations. Powder / solid drugs are often difficult to be precisely and uniformly distributed at the bleeding point due to the complex form of surgical wound, special position of surgical wound or existence of irregular gap; liquid is easy to be lost due to bleeding or body position change; and paste type has the problem of not closely adhering to the complex wound, resulting in insufficient contact of the drug with the wound and affecting the hemostatic effect. The essence of the above problems lies in that the existing hemostatic drugs lack a delivery carrier, resulting in that the drug cannot fully act on the bleeding site.

[0003] The current hemostatic technology and material have inherent limitations. Physical barrier materials (such as traditional gauze) can provide mechanical compression, but for dynamic bleeding sites (such as joints), they are easy to be displaced or detached due to tissue movement and are easy to adhere to the wound, causing secondary injury when replaced. Synthetic hydrogel materials can adhere to the wound, but the degradation rate and drug release are difficult to control, and some materials cause inflammatory reactions. The above technologies are limited by the physical properties of the materials or have biocompatibility defects, and cannot meet the urgent need for effective treatment of complex bleeding wounds.

[0004] CN107261193B discloses a freeze-dried hemostatic material cross-linked by an ionic cross-linking agent, which is a carboxymethyl chitosan cross-linked with polyvinyl alcohol by a physical cross-linking method. A broad-spectrum hemostatic and antibacterial agent is fixed in the carboxymethyl chitosan matrix to achieve rapid hemostasis. However, the freeze-dried material is rigid and has poor flexibility, and has poor adhesion to the wound, making it difficult to achieve effective hemostasis in all parts. CN104189941B combines thrombin and chitosan to prepare a chitosan freeze-dried body containing thrombin. This material has strong absorption capacity but poor adhesion of dry material to the wound and poor hemostatic effect. SUMMARY

[0005] The main purpose of the present application is to provide a hemostatic product suitable for bleeding wounds, which solves the key problem in the prior art that it is difficult to precisely apply hemostatic drugs to complex wounds by organically combining hemostatic drug solution with gel fiber substrate.

[0006] The object of the present application is achieved by a wound dressing with hemostatic function, comprising a gel fiber fabric with hydrophilic and porous structure as a base material, a hemostatic drug being loaded and distributed in the surface micropores or internal pore space of the gel fiber base material by surface coating or soaking, the gel fiber fabric being made of one or several of acylated chitosan fiber, carboxymethyl chitosan fiber, carboxymethyl cellulose (CMC) fiber, carboxyethyl cellulose fiber, alginate fiber, and hydrophilic polyvinyl formal fiber, the hemostatic drug being tranexamic acid or its derivative, thrombin, chitosan, or fibrinogen.

[0007] The present application has the following advantages: The present application utilizes the hygroscopicity of the gel fiber dressing and the softness of the wet gel to effectively deliver the hemostatic drug to each part of the wound surface, thereby achieving the purpose of effective hemostasis for complex wounds. By coating or soaking the hemostatic drug on the gel fiber base material, the hemostatic drug is complexed by the strong adsorption of the gel fiber, and then the wet gel material containing the drug is applied to the wound surface. Since the gel fiber has high liquid absorption performance, it can carry a large amount of hemostatic drug to achieve sustained release and maintain the supply of hemostatic material. In addition, the wet gel fiber base material is a flexible material that can fully conform to the wound surface, so that the hemostatic drug can be delivered to those narrow or special-shaped wound locations, solving the key problem that the drug in the prior art cannot precisely act on complex wounds. DETAILED DESCRIPTION

[0008] The technical solutions in the embodiments of the present application will be described below in a clear and complete manner. Obviously, the described embodiments are only some 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 a person of ordinary skill in the art without creative labor fall within the protection scope of the present application. In addition, the technical solutions of various embodiments can be combined with each other, but it must be based on the fact that a person of ordinary skill in the art can realize the combination, and when the combination of technical solutions appears to be contradictory or unachievable, it should be considered that the combination of technical solutions does not exist and is not within the protection scope claimed by the present application.

[0009] A wound dressing with hemostatic function, one side of the dressing with the hemostatic drug being a wound contact side, so as to facilitate the hemostatic drug to fully contact the wound and timely exert the hemostatic effect.

[0010] The base material is a gel fiber independent of the hemostatic drug, has good hygroscopicity and the ability to maintain a wet environment on the wound surface, and its porous structure allows the hemostatic drug to be distributed in the form of surface attachment or internal penetration, thereby maintaining the biological function of the base material itself and ensuring the stability of the active ingredients of the drug. The wet gel fiber adsorbs the hemostatic drug without chemical cross-linking, but only coexists by physical adsorption.

[0011] The hemostatic drug is divided into 1) liquid: having flowability, can be directly coated on the surface of the substrate or distributed in the internal pore space of the substrate by soaking, to realize the drug loading of the surface and three-dimensional structure; 2) powder / solid: needs to be dissolved in solvent to form a solution in advance, and then distributed in the porous structure of the substrate by surface coating or soaking.

[0012] The hemostatic drug has the functions of promoting blood coagulation, stopping bleeding or improving blood coagulation function, and preferably the hemostatic drug is at least one of tranexamic acid and its derivatives, thrombin, chitosan and fibrinogen.

[0013] In the present application: 1) tranexamic acid and its derivatives play an antifibrinolytic hemostatic role by inhibiting the activity of fibrinolysin; 2) thrombin directly catalyzes the conversion of fibrinogen into fibrin to form a blood clot network; 3) chitosan absorbs blood components and activates blood clotting factors to accelerate thrombus formation and achieve hemostasis due to its cationic properties; 4) fibrinogen participates in thrombus formation as a blood clotting factor.

[0014] The gel fiber is directly in contact with the wound, and therefore preferably has good moisture absorption performance and becomes a gel after absorbing moisture, and preferably the gel fiber is at least one of acylated chitosan fiber, carboxymethyl chitosan, sodium carboxymethyl cellulose (CMC) fiber, alginate fiber and hydrophilic polyvinyl formal fiber, or a combination of several thereof.

[0015] When used to contact the wound in the body, the gel fiber is further preferably degradable, that is, the hydrophilic chitosan fiber, sodium carboxymethyl cellulose (CMC) fiber and alginate fiber in the above-mentioned materials can be gradually degraded in the physiological environment of the body through enzymolysis / hydrolysis, the degradation products can be metabolized or absorbed by the human body, and the degradation period matches the wound healing process. Thus, while realizing the functions of moisture absorption and gel formation and physical hemostasis, the safety requirements of biocompatibility and no foreign body residue are met.

[0016] In the present application, the gel fiber substrate uses fibers with gel properties as the main raw material, and preferably the gel fiber substrate is a non-woven fabric, a knitted fabric or a woven fabric, allowing the hemostatic drug to be loaded by coating or soaking and distributed in the surface micropores or internal pore space.

[0017] The hemostatic drug and the gel fiber substrate can have completed the preparation, packaging and sterilization processes, that is, they have completed the preparation, packaging and sterilization processes respectively at the time of production, and when used, the hemostatic drug and the gel fiber substrate are combined in a clean and sterile environment in independent packages to form a wound hemostatic dressing which is then applied to the wound surface.

[0018] Specifically, the gel fiber has strong hygroscopicity, and can be adapted to various forms of hemostatic drugs such as liquid preparations, powders / solids and pastes. For powders / solids, the hemostatic drugs can be dissolved in water for injection or medical physiological saline first, and then combined with the gel fiber by smearing or soaking to ensure that the drugs fully penetrate into the interstitial space of the fiber in the form of a solution; for liquid preparations, the drugs can be directly coated on the surface of the gel fiber or uniformly distributed in the internal pore space of the gel fiber by soaking to realize rapid adsorption of the drugs by the hydrophilic surface of the gel fiber.

[0019] The powder / solid hemostatic drug is dissolved with 1-50 times of water for injection / medical physiological saline. 1-50 times means that the mass ratio of the hemostatic drug to the water for injection / medical physiological saline is 1:1-1:50.

[0020] Preferably, the powder / solid hemostatic drug is dissolved with 1-50 times of water for injection. Water for injection is a sterile, pyrogen-free water specially used for injection.

[0021] Preferably, the powder / solid hemostatic drug is dissolved with 1-50 times of medical physiological saline. Medical physiological saline refers to a sodium chloride aqueous solution that meets medical standards and has a similar osmotic pressure to human plasma, and the main component is 0.9% sodium chloride, and the solvent is water for injection.

[0022] In use, the drug-loaded substrate is directly covered on the bleeding wound surface to make the drug fully contact the bleeding site.

[0023] Example 1 1) In a clean and sterile environment, 0.20 g of tranexamic acid powder was weighed, and 10 mL of water for injection was measured in a sterile beaker to dissolve the tranexamic acid powder.

[0024] 2) A carboxymethyl cellulose sodium (CMC) fiber substrate dressing with a size of 10 cm x 10 cm and a weight of 120 g was prepared.

[0025] 3) The carboxymethyl cellulose sodium (CMC) fiber dressing was soaked in the dissolved tranexamic acid solution for at least 1-2 minutes, and then the wet dressing was directly placed on the surgical wound site for hemostasis.

[0026] Example 2 1) In a clean and sterile environment, 0.50 g of tranexamic acid powder was weighed, and 10 mL of water for injection was measured in a sterile beaker to dissolve the tranexamic acid powder.

[0027] 2) A alginate fiber substrate dressing with a size of 10 cm x 10 cm and a weight of 120 g was prepared.

[0028] 3) The dissolved tranexamic acid solution is applied or soaked in the alginate fiber substrate, and the wet dressing is placed in a waterproof sealed device for sterilization for clinical use.

[0029] Example 3 1) In a clean and sterile environment, prepare 1.00 g of tranexamic acid powder, and dissolve the tranexamic acid powder in 10 mL of water for injection in a sterile beaker.

[0030] 2) Prepare a hydrophilic chitosan fiber substrate dressing with a size of 10 cm x 10 cm and a weight of 120 g for standby use.

[0031] 3) The dissolved tranexamic acid solution is applied or soaked in the hydrophilic chitosan fiber substrate, and the wet dressing is placed in a waterproof sealed device for sterilization for standby use.

[0032] Example 4 1) In a clean and sterile environment, weigh 0.1 U of thrombin hemostatic powder, and dissolve the thrombin powder completely in 10 mL of medical saline in a sterile beaker.

[0033] 2) Prepare a hydrophilic chitosan fiber substrate dressing with a size of 10 cm x 10 cm and a weight of 120 g for standby use.

[0034] 3) The dissolved thrombin solution is applied or soaked in the hydrophilic chitosan fiber substrate, and the wet dressing is placed in a waterproof sealed device for sterilization for standby use.

[0035] Example 5 1) In a clean and sterile environment, take 10 mL of carboxyamino dextran sodium biological colloid liquid in a sterile beaker.

[0036] 2) Prepare a carboxymethyl cellulose sodium (CMC) fiber substrate dressing with a size of 10 cm x 10 cm and a weight of 200 g for standby use.

[0037] 3) The carboxyamino dextran sodium biological colloid liquid in the sterile beaker is applied or soaked in the carboxymethyl cellulose sodium (CMC) fiber substrate, and the wet dressing is directly placed on the surgical site for hemostasis.

[0038] Example 6 1) In a clean and sterile environment, take 5 mL of a wound dressing made of a derivative of chitosan in a sterile beaker.

[0039] 2) Prepare an alginate fiber substrate dressing with a size of 10 cm x 10 cm and a weight of 120 g for standby use.

[0040] 3) The liquid wound dressing in the sterile beaker is applied to the carboxymethyl cellulose sodium (CMC) fiber substrate, and the wet dressing is placed in a waterproof sealed device for sterilization.

[0041] Example 7 1) In a clean and sterile environment, prepare the hemostatic powder made of chitosan, and weigh 0.50 g, and measure 10 mL of water for injection in a sterile beaker to dissolve the chitosan hemostatic powder.

[0042] 2) Prepare a hydrophilic chitosan fiber substrate dressing with a specification of 10 cm x 10 cm and 120 gsm.

[0043] 3) Apply or soak the dissolved chitosan hemostatic powder solution in the hydrophilic chitosan fiber substrate, and sterilize the wet dressing in a waterproof sealed device.

[0044] Example 8 1) In a clean and sterile environment, prepare the hemostatic powder made of chitosan, and weigh 1.00 g, and measure 10 mL of water for injection in a sterile beaker to dissolve the chitosan hemostatic powder.

[0045] 2) Prepare an alginate fiber substrate dressing with a specification of 10 cm x 10 cm and 120 gsm.

[0046] 3) Apply or soak the dissolved chitosan hemostatic solution in the alginate fiber substrate, and sterilize the wet dressing in a waterproof sealed device.

[0047] The above description is only a preferred embodiment of the present application, but the protection scope of the present application is not limited thereto, and any person skilled in the art can make equivalent replacements or changes according to the technical solution and the inventive concept of the present application within the technical scope disclosed by the present application, which should be covered within the protection scope of the present application.

Claims

1. A wound dressing with hemostatic function, characterized in that: The gel fiber fabric with hydrophilic and porous structure is used as the base material, and hemostatic drugs are loaded and distributed in the surface micropores or internal pore space of the gel fiber base material by surface coating or soaking.

2. The wound dressing with hemostatic function according to claim 1, characterized in that, The gel fiber fabric is made of one or more of acylated chitosan fiber, carboxymethyl chitosan fiber, carboxymethyl cellulose fiber, carboxyethyl cellulose fiber, alginate fiber and hydrophilic polyvinyl formal fiber.

3. The wound dressing with hemostatic function according to claim 1, characterized in that, The hemostatic drugs are one or more of tranexamic acid or its derivatives, thrombin, chitosan or fibrinogen.

4. The wound dressing with hemostatic function according to claim 1, characterized in that, The hemostatic drugs are liquid drugs, which are loaded and distributed in the internal pore space of the base material by soaking.

5. The wound dressing with hemostatic function according to claim 1, characterized in that, The hemostatic drugs are water-soluble powders or solids, which are coated on the surface of the base material or loaded and distributed in the internal pore space of the base material by soaking after being dissolved in water.

6. The wound dressing with hemostatic function according to claim 2, characterized in that, The gel fiber fabric is a non-woven fabric, a knitted fabric or a woven fabric before being wetted.