CN114272432B - Preparation method of novel hemostatic sponge composite material for cerebral surgery - Google Patents
Preparation method of novel hemostatic sponge composite material for cerebral surgery Download PDFInfo
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Abstract
The invention discloses a preparation method of a novel hemostatic sponge composite material for cerebral surgery, which comprises a cerebral cotton sheet layer, an adhesive layer and a hemostatic sponge layer. The brain cotton sheet has water absorption and can absorb a large amount of liquid; the hemostatic sponge layer has the characteristics of hydrophilicity and porous structure, is beneficial to the aggregation of blood platelets at the wound surface and promotes blood coagulation and wound healing; medical dextrin is the medical adhesive commonly used, has the adhesion, and is soluble in water, soaks a period back with novel hemostasis sponge paster in the aquatic, and the operation process that takes out the brain cotton piece and put into the hemostasis sponge again can be realized breaking away from comparatively easily with the hemostasis sponge to the brain cotton piece, reduces medical personnel work load, shortens operation time.
Description
Technical Field
The invention relates to the field of biomedical materials, and relates to a preparation method of a novel hemostatic sponge composite material for cerebral surgery.
Background
Surgical operation, trauma and first aid all can be bleedings to the outside intentionally, can form the bleeding wound, need in time to take effective hemostasis measure, especially uncontrollable unexpected bleeding has very high requirement to hemostasis speed and effect, once the excessive blood loss can cause life threatening. The operation time is generally longer, and the research of the hemostatic material which can achieve the effect of simplicity and timeliness has important significance. The external injury is stopped by an external application hemostatic material or a gauze winding mode, the commonly used adhesives in the external application material mainly comprise chemical adhesives and biological adhesives, the chemical adhesives mainly comprise propylene and polyurethane, and the biological adhesives mainly comprise fibrin adhesives. The chemical adhesive needs to be carefully used due to biocompatibility, and the fibrin adhesive is used as biological glue in the hemostatic operation of brain surgery, but is not suitable to be used as the adhesive between a medical brain cotton sheet layer and a hemostatic sponge due to the problems of high price, low-temperature storage, pretreatment during use, complex operation and the like.
Medical dextrin is an incomplete hydrolysate prepared by acid or heat treatment of starch, has the characteristics of no toxicity, no stimulation, adhesion, remoisturity, solubility and easy water solubility, can generate an aggregation tendency along with the change of temperature and density of a medical dextrin aqueous solution, has the characteristic of thixotropy, becomes paste or gel after standing, can cause viscosity increase along with the aging or gelation of the solution, is often used as a binder of surgical dressings, can also be used as a binder of tablet particles, and is used as a plasticizer and a binder in sugar coatings.
In the invention patent with application number 202021639239, a composite brain surgery auxiliary material is provided, wherein a first auxiliary material layer and a second auxiliary material layer (a porous hemostatic material) are isolated by a layer of plastic film or latex, so that separation, compression and water absorption can be realized simultaneously to achieve a hemostatic effect, the operation is simplified, and the operation time is shortened. But compound auxiliary material in this application, mainly through tearing the realization separation between two auxiliary material layers, the plastic film who has the intermediate level in the separation process remains on hemostasis sponge layer, if hemostasis sponge need keep somewhere stanchs in the brain, plastic film's security can threaten life safety, tear the in-process intermediate level of drawing the separation moreover and appear the circumstances such as fracture also can bring inconvenience for doctor's operation.
The invention discloses a preparation technology of a novel rapid hemostatic sponge patch, which is disclosed in an invention patent with the application number of 201510401337.8, wherein a used adhesive is mixed glue prepared from multiple components such as propylene, silicone, polyurethane, natural rubber and the like according to a certain proportion, in the preparation process of the hemostatic sponge patch, foam containing thrombin components is sprayed on a base material coated with the adhesive in advance, freeze drying is carried out to remove moisture, the obtained spongy hemostatic sponge patch is used for hemostasis of a liver part, the hemostatic sponge patch is attached to a wound surface, and after a material and the wound surface form coagulates, the material is carefully peeled off from the wound surface, so that effective hemostasis is realized, and scar generation is avoided. The hemostatic sponge patch of this patent application, because it contains chemical patch components, is still not suitable for brain surgery, and in other applications, it still needs to be carefully observed whether the residue of chemical adhesive is harmful to human body.
Therefore, an adhesive with good biocompatibility needs to be found, which effectively combines a brain cotton sheet capable of absorbing blood with a hemostatic sponge patch with a hemostatic function, ensures the flexibility of the hemostatic sponge patch, and achieves the purposes of rapid hemostasis in brain surgery and simplification of the operation process. The thickness of the hemostatic sponge is designed to bring more convenience to the operation.
Disclosure of Invention
The invention aims to provide a preparation method of a hemostatic sponge patch which is prepared by bonding a brain cotton sheet and a hemostatic sponge by using an adhesive and can realize simple and convenient separation and quick and effective hemostasis under the soaking of normal saline, and solves the problems of large demand on the brain cotton sheet, low hemostasis speed, complex operation, secondary injury caused by tearing of a wound and the like in the current surgical hemostasis process. In order to realize the purpose, the invention discloses a preparation method of a composite hemostatic sponge material capable of realizing quick separation, which adopts the following technical scheme:
a method for preparing a novel hemostatic sponge composite material for cerebral surgery comprises the steps of cutting a brain cotton sheet into proper sizes, threading barium wires or nylon wires according to requirements, adding medical starch or medical dextrin into a certain amount of water, heating the starch or the dextrin in a water bath kettle to form a sticky adhesive, uniformly coating the adhesive on the brain cotton sheet to form a thin adhesive layer on the surface of the brain cotton sheet, attaching hemostatic sponge on the adhesive layer, utilizing the adhesive property of the medical starch or the medical dextrin to adhere the brain cotton sheet layer and the hemostatic sponge layer, drying a sample, packaging and sterilizing.
Furthermore, the novel hemostatic sponge composite material for cerebral surgery consists of a cerebral cotton sheet layer, an adhesive layer and a hemostatic sponge layer.
Furthermore, the novel hemostatic sponge composite material for cerebral surgery is characterized in that the cerebral cotton sheet is made of cotton fibers as a main body and X-ray detectable barium threads or polyester threads as auxiliary materials.
Furthermore, the raw materials of the adhesive used by the novel hemostatic sponge composite material for brain surgery are preferably medical starch and medical dextrin.
Further, the preparation temperature of the adhesive is in the range of 60-80 ℃, and the preferable temperature is in the range of 70-80 ℃.
The concentration of the adhesive is within the range of 0.2 to 1g/mL, and preferably 0.5 to 0.6g/mL.
Furthermore, the dosage of the adhesive is within the range of 0.03 to 0.07mL.
Further, the hemostatic sponge comprises materials such as but not limited to gelatin and chitosan.
Further, the drying method of the novel hemostatic sponge composite material for brain surgery is preferably a drying condition of drying by blowing at 40 ℃ for 5 min.
The technical scheme provided by the invention has the beneficial effects that:
(1) The hemostatic sponge composite material has the advantages of simple preparation method, convenient operation in use, low cost of selected raw materials, good biocompatibility, degradation of the hemostatic sponge in a human body, no need of taking out the hemostatic sponge again after internal operation hemostasis, simplified operation process, and reduced secondary damage to the wound surface of the operation; the medical dextrin adhesive has the characteristics of no toxicity and no stimulation, is not only used in brain surgery, but also can be widely used for stopping bleeding of various wounds and tissues of operation wounds.
(2) When the medical starch or medical dextrin used by the invention is used as an adhesive, the adhesive has good bonding strength, good hydrophilicity and good bonding and rewetting solubility, so that the hemostatic sponge composite material can be ensured to have good bonding under a dry condition, and the hemostatic sponge patch can be easily separated under a humid condition (soaked in normal saline).
(3) The hemostatic sponge composite material disclosed by the invention combines the advantages of the brain cotton sheet and the hemostatic sponge, and has the advantages of obviously and rapidly absorbing a large amount of liquid, improving the hemostatic efficiency and shortening the clinical hemostatic time.
(4) The hemostatic sponge composite material provided by the invention is dried, so that the prepared material still keeps good shape and softness, the problems of deformation and hardening do not occur, and the structure of the hemostatic sponge is not greatly influenced.
Drawings
Fig. 1 is a schematic structural diagram of a hemostatic sponge composite material.
In the figure: 1. a brain cotton sheet layer; 2. the X-ray can detect the barium thread or the polyester thread; 3. an adhesive layer; 4. a hemostatic sponge layer.
Detailed Description
In order to facilitate understanding of the objects, aspects and effects of the present invention, the following detailed description will be given of the aspects of the present invention with reference to the examples.
Example 1
Cutting the brain cotton sheet into 8 x 2 x 0.5cm, threading barium thread or nylon thread according to requirements, and sealing one section far away from the brain cotton sheet. Weighing 2g of medical dextrin, pouring the medical dextrin into a beaker filled with 10mL of water, heating and stirring the medical dextrin in a water bath at 70 ℃ to dissolve the medical dextrin to form white sticky matter with certain viscosity. Uniformly coating 0.05mL of adhesive on a brain cotton piece, then pasting the surface of the gelatin sponge on the adhesive, lightly pressing with hands, drying the material in an oven at 30 ℃ for 10min, taking out, packaging with a paper-plastic bag, and sterilizing with ethylene oxide to obtain the novel hemostatic sponge composite material, wherein the sterilized material keeps good flexibility, bonding strength and shape.
Example 2
Cutting the brain cotton sheet into 8 x 2 x 0.4cm, threading a barium thread or a nylon thread according to requirements, and sealing one section far away from the brain cotton sheet. 5g of medical dextrin is weighed and poured into a beaker filled with 10mL of water, and the medical dextrin is heated and stirred in a water bath at 75 ℃ to be dissolved to form white sticky matter with certain viscosity. Uniformly coating 0.03mL of adhesive on a brain cotton sheet, then pasting the surface of the gelatin sponge on the adhesive, lightly pressing with hands, drying the patch in an oven at 30 ℃ for 5min, taking out, packaging with a paper-plastic bag, and sterilizing with ethylene oxide to obtain the novel hemostatic sponge composite material, wherein the sterilized material keeps good flexibility, bonding strength and shape.
Example 3
Cutting the brain cotton sheet into 8 x 2 x 0.2cm, threading barium thread or nylon thread according to requirements, and sealing one section far away from the brain cotton sheet. Weighing 6g of medical dextrin, pouring the medical dextrin into a beaker filled with 10mL of water, heating and stirring the medical dextrin in a water bath at 78 ℃ to dissolve the medical dextrin to form white sticky matter with certain viscosity. Uniformly coating 0.04mL of adhesive on a brain cotton sheet, then pasting the surface of the gelatin sponge on the adhesive, lightly pressing with hands, drying the patch in an oven at 50 ℃ for 7min, taking out, packaging with a paper-plastic bag, and sterilizing with ethylene oxide to obtain the novel hemostatic sponge composite material, wherein the sterilized material keeps good flexibility, bonding strength and shape.
Example 4
Cutting the brain cotton sheet into 8 × 2 × 0.2cm, threading barium thread or nylon thread according to requirements, and sealing one section far away from the brain cotton sheet. 10g of medical dextrin is weighed and poured into a beaker filled with 10mL of water, and the medical dextrin is heated and stirred in a water bath at 80 ℃ to be dissolved to form white sticky matter with certain viscosity. Uniformly coating 0.07mL of adhesive on a brain cotton sheet, then pasting the surface of the gelatin sponge on the adhesive, lightly pressing with hands, drying the patch in an oven at 60 ℃ for 3min, taking out, packaging with a paper-plastic bag, and sterilizing with ethylene oxide to obtain the novel hemostatic sponge composite material, wherein the sterilized material keeps good flexibility, bonding strength and shape.
Comparative example 1
Cutting the brain cotton sheet into 8 × 2 × 0.2cm, threading barium thread or nylon thread according to requirements, and sealing one section far away from the brain cotton sheet. 1.5g of medical dextrin is weighed and poured into a beaker filled with 10mL of water, and is heated and stirred in a water bath at 70 ℃ for dissolution to form white sticky matter with certain viscosity. And (3) uniformly coating 0.1mL of adhesive on a brain cotton piece, then pasting the surface of the gelatin sponge on the adhesive, lightly pressing by hands, drying the material in an oven at 30 ℃ for 10min, then taking out, packaging with a paper-plastic bag, and sterilizing with ethylene oxide to obtain the novel hemostatic sponge composite material.
Comparative example 2
Cutting the brain cotton sheet into 8 x 2 x 0.5cm, threading barium thread or nylon thread according to requirements, and sealing one section far away from the brain cotton sheet. Weighing 11g of medical dextrin, pouring the medical dextrin into a beaker filled with 10mL of water, heating and stirring the medical dextrin in a water bath at the temperature of 80 ℃ to dissolve the medical dextrin to form white sticky matter with certain viscosity. And (3) uniformly coating 0.02mL of adhesive on a brain cotton sheet, then adhering the surface of the gelatin sponge on the adhesive, lightly pressing by hands, drying the adhesive in a drying oven at 60 ℃ for 3min, taking out, packaging with a paper-plastic bag, and sterilizing with ethylene oxide to obtain the novel hemostatic sponge composite material. It was found that too high a concentration of binder, uneven smearing, had a certain effect on the flexibility and shape of the material.
Experimental testing
The novel hemostatic sponge composite material was tested according to the water absorption rate test and the soaking separation test, and the results are shown in tables 1 and 2.
Test of Water absorption Rate
The test method comprises the following steps:
weighing a whole piece of hemostatic sponge A1, spreading in a watch glass containing excessive water, completely soaking at room temperature for 30min, absorbing water, holding one end with forceps for 30s, weighing patch mass A2, calculating water absorption, testing each group of samples for 6 times, and averaging.
The water absorption multiple is calculated by the following formula: water absorption multiple = (A2-A1)/A1, where A1 (g) is the starting mass and A2 (g) is the mass after soaking.
And (3) test results: as shown in Table 1
TABLE 1 test result of water absorption multiple of novel hemostatic sponge composite material for brain surgery
| Serial number | Example 1 | Example 2 | Example 3 | Example 4 | Comparative example 1 | Comparative example 2 |
| Water absorption multiple | 17.3 | 16.4 | 13.4 | 15.2 | 15.3 | 15.1 |
As can be seen from examples 1-6 in Table 1, the water absorption rate of the novel hemostatic sponge composite material is as high as more than 13 times of its own weight. The water absorption capacity of the material is mainly related to the thickness of the hemostatic sponge layer, and the water absorption capacity is obviously increased along with the increase of the thickness. The concentration of the binder has no significant effect on the water absorption capacity of the material. The hemostatic sponge has a pore structure which has better water absorption capacity than a brain cotton sheet, and the existence of the pore structure can better maintain the stable state of absorption liquid and effectively improve the hemostatic speed.
Immersion separation test
The test method comprises the following steps:
a whole piece of 8 x 2 x 0.5cm hemostatic sponge was left to soak in a watch dish containing physiological saline and observed for sample separation every 10s at room temperature.
And (3) test results: as shown in Table 2
TABLE 2 detection results of separation time after soaking of novel hemostatic sponge composite material for cerebral surgery
| Serial number | Example 1 | Example 2 | Example 3 | Example 4 | Comparative example 1 | Comparative example 2 |
| Separation time (min) | 5 | 8 | 10 | 15 | 1 | 30 |
As shown in Table 2, the novel hemostatic sponge composite material shows different separation times according to different concentrations and dosages of the adhesive layer when soaked in physiological saline. Within the concentration range protected by the application, the hemostatic materials in the examples can maintain the adhesion for 5-15min under the wet condition, and the adhesion time is kept to be short due to the fact that the concentration of the adhesive used in comparative example 1 is too low; comparative example 2 shows that the adhesive concentration is too high, the adhesive time is too long, and both of the cases in the comparative example affect the operation process. Therefore, in order to avoid the influence caused by accidental separation of materials, the materials capable of maintaining the bonding strength for more than 5min are generally selected, and the bonding strength of the novel hemostatic sponge composite material can be controllably adjusted according to the actual use condition. The characteristics of rewetting solubility of the adhesive are proved to be beneficial to maintaining better bonding between the brain cotton sheet and the hemostatic sponge, meanwhile, the adhesive can be easily separated under a humid condition, the problem of damaging the shape and the structure of the material due to excessive force is avoided, the novel hemostatic sponge composite material has the characteristics of high bonding degree and simple separation, and the current operation process is effectively simplified.
The above disclosure is only for a few specific embodiments of the present invention, but the present invention is not limited thereto, and any variations that can be considered by those skilled in the art are intended to be within the scope of the present invention.
Claims (5)
1. A method of preparing a hemostatic sponge composite useful for brain surgery, the method comprising the steps of: cutting a brain cotton sheet into a proper size, threading a barium wire or a nylon wire according to requirements, uniformly coating an adhesive with the concentration of 0.2 to 1g/mL on the brain cotton sheet, taking 0.03 to 0.07mL to coat the adhesive on the brain cotton sheet, forming a thin adhesive layer on the surface of the brain cotton sheet, then attaching a hemostatic sponge on the adhesive layer, drying, packaging and sterilizing, wherein the novel hemostatic sponge composite material consists of the brain cotton sheet, the adhesive layer and the hemostatic sponge, and can maintain the adhesive effect for 5 to 15min under a humid condition after being soaked in physiological saline, and the raw materials of the adhesive comprise medical starch, medical dextrin, polyethylene glycol and hydroxymethyl cellulose.
2. The method for preparing a hemostatic sponge composite material for brain surgery as claimed in claim 1, wherein the brain cotton sheet is made of cotton fiber as main body and X-ray detectable barium thread or polyester thread as auxiliary material.
3. The preparation method of the hemostatic sponge composite material for brain surgery as claimed in claim 1, wherein the preparation temperature of the medical starch and medical dextrin adhesive is in the range of 60 to 80 ℃.
4. The method for preparing a hemostatic sponge composite material for brain surgery as claimed in claim 1, wherein the hemostatic sponge comprises gelatin and chitosan, and has a length of 1 to 20cm, a width of 1 to 10cm and a thickness of 0.2 to 1cm.
5. The preparation method of the hemostatic sponge composite material for brain surgery as claimed in claim 1, wherein the drying method comprises air drying at 20 to 80 ℃ for 2min to 30min.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102234955B (en) * | 2011-04-21 | 2013-11-20 | 金东纸业（江苏）股份有限公司 | Medical-use printing paper, and manufacture method thereof |
| CN102274541A (en) * | 2011-09-09 | 2011-12-14 | 天津禹王生物医药科技有限公司 | Hemostatic material |
| US9056092B2 (en) * | 2011-12-02 | 2015-06-16 | Ethicon, Inc. | Hemostatic bioabsorbable device with polyethylene glycol binder |
| CN103481549B (en) * | 2013-08-27 | 2015-04-08 | 山东领潮新材料有限公司 | Alginate fiber electrostatic flocking fabric for medical treatment and manufacturing method thereof |
| CN105287106A (en) * | 2015-11-03 | 2016-02-03 | 中国人民解放军第四军医大学 | Bandage dressing special for limb war wound first aid |
| CN209713012U (en) * | 2018-11-27 | 2019-12-03 | 天津医科大学总医院 | a brain plate |
| CN213310895U (en) * | 2020-08-10 | 2021-06-01 | 武汉布润脑医学科技有限责任公司 | Composite brain surgery dressing |
| CN112826975B (en) * | 2021-01-29 | 2022-04-15 | 欣乐加生物科技温州有限公司 | Medical chitosan rapid hemostatic dressing and preparation method thereof |
| CN113663120B (en) * | 2021-09-28 | 2022-10-28 | 桂林福康森医疗器械有限公司 | Hemostatic sponge cushion core and preparation method thereof |
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