CN110522954B - Barium sulfate-containing developable composite biological patch and preparation method thereof - Google Patents
Barium sulfate-containing developable composite biological patch and preparation method thereof Download PDFInfo
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- CN110522954B CN110522954B CN201910874175.8A CN201910874175A CN110522954B CN 110522954 B CN110522954 B CN 110522954B CN 201910874175 A CN201910874175 A CN 201910874175A CN 110522954 B CN110522954 B CN 110522954B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/04—X-ray contrast preparations
- A61K49/0404—X-ray contrast preparations containing barium sulfate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/028—Other inorganic materials not covered by A61L31/022 - A61L31/026
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
Abstract
The invention belongs to the field of biomedical engineering, and particularly relates to a barium sulfate-containing developable composite biological patch and a preparation method thereof. The mass percentage of barium sulfate in the composite biological patch is 15-35%, and the composite biological patch has good mechanical property and development strength. The invention also discloses a preparation method of the composite biological patch, which comprises the following steps: 1) preparing a polypropylene solution, adding nano barium sulfate, and uniformly stirring to obtain a polypropylene/nano barium sulfate solution; (2) adding the polypropylene/nano barium sulfate solution into a coagulating bath for phase conversion and solidification, taking out, washing and drying in vacuum to obtain a polypropylene/nano barium sulfate composite material; (3) extruding and granulating the polypropylene/nano barium sulfate composite material by a co-rotating double-screw extruder to obtain a composite biological patch raw material; (4) and extruding and spinning by a single screw extruder to prepare composite fiber, and weaving to prepare the barium sulfate-containing developable composite biological patch. The preparation method is simple and suitable for industrial production.
Description
Technical Field
The invention relates to the field of biomedical engineering, in particular to a barium sulfate-containing developable composite biological patch and a preparation method thereof.
Background
Hernia is one of the common and frequently encountered diseases in general surgery and occurs at all ages. Displaying according to the related data: there are about 2000 ten thousand hernia repair procedures worldwide each year, with 80% of the procedures requiring hernia patches. Tension-free hernia repair is the most widely used hernia repair operation at present, and biological patches made of high polymer materials such as polypropylene are widely used as hernia patches. The hernia patch is implanted in the human body to resist the internal pressure of the human body and support the newly formed tissue, so the patch must have a stable structure, sufficient strength and softness. Therefore, the main physical and mechanical properties for measuring the quality of the repairing net comprise tensile breaking strength, bursting strength, rigidity and flexibility, wrinkle recovery and other indexes.
According to the requirements of clinical operation, the hernia patch in the future should be researched and developed in the directions of having good antibacterial ability, preventing tissue adhesion and hemolytic reaction, having good tissue support, being completely or partially absorbed by human body, reducing the influence of post-operation patch contraction on the wound, even assisting the regeneration of endogenous tissues, repairing the operation wound area, reducing the generation of post-operation scar tissues, so as to relieve the pain of patients to the greatest extent and improve prognosis.
The polypropylene material has the advantages of stable chemical property, higher physical tension strength, firm weaving, good hand feeling, infection resistance, repeated bending resistance and the like, the polypropylene patch woven by using the polypropylene material has the characteristics of easy tissue ingrowth and granulation tissue proliferation, and the pore size of the polypropylene patch is larger, so that leucocytes and macrophages can enter and exit, and bacteria in a mesh of the patch can be killed, therefore, the patch has excellent anti-infection effect and is widely applied to hernia repair. Meanwhile, the polypropylene patch has the advantages of low price, capability of stimulating tissue healing, small operation wound, quick postoperative recovery and the like, and becomes the most commonly used artificial synthesis non-absorbable patch in the hernia repair operation. However, in current use polypropylene patches have been found to have some disadvantages: for example, the polypropylene patch has a rough surface, and can cause severe abdominal adhesion when directly contacted with abdominal organs, even erode intestinal walls, thereby causing intestinal fistulas or intestinal obstruction.
The single-material patch often has the problems of incompatible and unstable biomechanical performance and serious weight type and adhesion phenomena. In order to solve the above problems, composite hernia repair materials combining the advantages of both materials are emerging. Composite hernia patches are typically made by integrally weaving, sewing, bonding, laminating, etc. Common composite patches can be divided into mechanical reinforcing patches, partially degradable patches and anti-adhesion patches according to composite purposes, and can be divided into polypropylene and expanded polytetrafluoroethylene material combined patches, polypropylene and absorbable material combined multi-layer patches and the like according to materials.
Clinical application shows that the biological patch prepared from the high polymer material obviously shrinks scars (the shrinkage rate can reach 20% -50%) in the later period of the hernia repair operation, the high polymer material biological patch is twisted, and the irregular surface of the biological patch can stimulate and even damage surrounding tissues, so that the formation of skin sinuses and infection are caused. At this point a second operation should be performed to remove the already distorted patch for replacement.
Bacterial infection after hernia repair is also one of more serious complications, and a large amount of published clinical statistical data at home and abroad indicate that the incidence rate of infection after hernia repair is 6-10%, and particularly the incidence rate of infection after incisional hernia is about 40%. Severe postoperative infection can lead to prolonged hospitalization of the patient with poor prognosis and even the need for subsequent surgery to clean the infected site.
It follows that post-hernia repair infection is also one of the more serious complications. Two infection factors exist, one is bacterial infection, and a large amount of published clinical statistical data at home and abroad indicate that the infection incidence rate after the hernia repair is 6-10 percent; the other is that the high polymer material biological patch is twisted, and the irregular surface of the biological patch can stimulate and even damage surrounding tissues, thereby causing the formation of skin sinus and infection. The clinical treatment of these two infections is quite different. The former should be treated against infection, and the latter should be subjected to a secondary operation. At present, the two lesions are clinically distinguished by the clinical experience of doctors, sometimes cannot be distinguished, and only can be detected by operation, which brings extra pain and burden to patients. Therefore, it is an urgent problem to find the cause of postoperative infection and provide basis for clinical diagnosis and treatment by non-operative means.
Disclosure of Invention
In view of the above, the invention aims to provide a barium sulfate-containing developable composite biological patch and a preparation method thereof.
In order to solve the technical problems, the invention provides a barium sulfate-containing developable composite biological patch, which comprises the following components in percentage by mass: 65-85% of polypropylene and 15-35% of nano barium sulfate.
Preferably, the thickness of the composite biological patch is 0.6mm, and the pore diameter of the composite biological patch is 2 mm.
Preferably, the polypropylene is medical grade isotactic polypropylene, the melting point is 164-170 ℃, and the isotactic index is more than or equal to 96%.
Preferably, the particle size range of the nano barium sulfate is 30-70 nm.
The invention also provides a preparation method of the barium sulfate-containing developable composite biological patch, which comprises the following steps:
(1) dissolving polypropylene in an organic solvent to obtain a polypropylene solution, adding nano barium sulfate into the polypropylene solution, and stirring until the nano barium sulfate and the nano barium sulfate are uniformly mixed to obtain a polypropylene/nano barium sulfate solution;
(2) adding the polypropylene/nano barium sulfate solution obtained in the step (1) into a coagulating bath with the same volume for phase conversion and solidification, taking out after solidification, washing, and drying in vacuum to obtain a polypropylene/nano barium sulfate composite material;
(3) extruding and granulating the polypropylene/nano barium sulfate composite material by a co-rotating double-screw extruder to obtain a composite biological patch raw material;
(4) and extruding and spinning the raw material of the composite biological patch by a single-screw extruder to prepare composite fibers, and weaving and processing the composite fibers to prepare the barium sulfate-containing developable composite biological patch.
Preferably, the organic solvent in step (1) is one or more of toluene, xylene and decalin.
Preferably, in the step (1), the temperature for dissolving the polypropylene in the organic solvent is 100-120 ℃; the concentration of polypropylene in the polypropylene solution is 100-125 g/L; the stirring time is 2-4 h.
Preferably, the coagulating bath in step (2) comprises one of absolute ethanol or acetone.
Preferably, the extrusion temperature in the step (3) is 150-200 ℃; the rotating speed of the screw is 60-120 r/min.
Preferably, the extrusion temperature in the step (4) is 150-220 ℃.
Compared with the prior art, the invention ensures the tensile strength of the biological patch by adding a certain amount (15-35%) of barium sulfate capable of developing into the raw material of the macromolecular biological patch, and can judge whether the biological patch is distorted or not through X-ray inspection, thereby providing a basis for clinical diagnosis and treatment.
Detailed Description
For a further understanding of the invention, reference will now be made to the preferred embodiments of the present invention by way of example, and it is to be understood that the description is intended to further illustrate features and advantages of the present invention and is not intended to limit the scope of the claims which follow.
All of the starting materials of the present invention, without particular limitation as to their source, may be purchased commercially or prepared according to conventional methods well known to those skilled in the art.
The invention provides a barium sulfate-containing developable composite biological patch, which comprises the following components in percentage by mass: 65-85% of polypropylene and 15-35% of nano barium sulfate.
In the invention, the thickness of the composite biological patch is preferably 0.6mm, and the pore diameter of the composite biological patch is preferably 2 mm.
The polypropylene is medical-grade isotactic polypropylene, the melting point is 164-170 ℃, and the isotactic index is more than or equal to 96%.
The composite biological patch provided by the invention comprises polypropylene and nano barium sulfate. The polypropylene material has the advantages of stable chemical property, higher physical tension strength, firm weaving, good hand feeling, infection tolerance, repeated bending resistance and the like, the polypropylene patch woven by using the polypropylene material has the characteristics of easy tissue ingrowth and granulation tissue proliferation, and the pore size of the woven polypropylene patch is larger, so that leucocytes and macrophages can enter and exit, and bacteria in a mesh of the patch can be killed, therefore, the patch has excellent anti-infection effect, can stimulate the tissue healing, and has the advantages of small surgical wound, quicker postoperative recovery and the like. According to the invention, the content of polypropylene is 65-85% by mass, so that the tensile strength of the composite biological patch meets the requirement of the biological patch for hernia operation on strength. Barium sulfate is white loose fine powder and is an X-ray double contrast agent. The fine and uniform barium preparation is mostly synthetic barium, has fine and uniform particles, is mostly round, has lighter specific gravity and slow and consistent sedimentation, and is widely suitable for single and double contrast radiography examination of esophagus, stomach, duodenum, small intestine and colon. The content of barium sulfate affects the development effect and the mechanical property of the composite biological patch. With the increase of the content of barium sulfate, the mechanical property of the biological patch is reduced. However, if the barium sulfate content is too low, the development strength of the biological patch is not strong enough. Tests prove that the patch with the barium sulfate content of 15-35% can meet the requirements of development strength and mechanical property.
In the invention, the particle size range of the nano barium sulfate is preferably 30-70 nm. The nano barium sulfate with the particle size of 30-70 nm has a large specific surface area, the higher the possibility of physical or chemical action with a high polymer material is, the stronger the capacity of being adsorbed on melts such as polypropylene and the like is, the interface bonding force is enhanced, the interface layer is relatively thin, and the strength and the tensile property are better.
The invention also provides a preparation method of the barium sulfate-containing developable composite biological patch, which comprises the following steps:
(1) dissolving polypropylene in an organic solvent to obtain a polypropylene solution, adding nano barium sulfate into the polypropylene solution, and stirring until the nano barium sulfate and the nano barium sulfate are uniformly mixed to obtain a polypropylene/nano barium sulfate solution;
(2) adding the polypropylene/nano barium sulfate solution obtained in the step (1) into a coagulating bath with the same volume for phase conversion and solidification, taking out after solidification, washing, and drying in vacuum to obtain a polypropylene/nano barium sulfate composite material;
(3) extruding and granulating the polypropylene/nano barium sulfate composite material by a co-rotating double-screw extruder to obtain a composite biological patch raw material;
(4) and extruding and spinning the raw material of the composite biological patch by a single-screw extruder to prepare composite fibers, and weaving and processing the composite fibers to prepare the barium sulfate-containing developable composite biological patch.
In order to increase the addition of barium sulfate and prepare uniform barium sulfate polymer blending material, the invention adopts a solution blending method for granulation. Specifically, firstly, polypropylene is dissolved in an organic solvent to obtain a polypropylene solution, and nano barium sulfate is added into the polypropylene solution and stirred until the nano barium sulfate and the nano barium sulfate are uniformly mixed to obtain a polypropylene/nano barium sulfate solution. The source of the polypropylene is not particularly limited in the present invention, and polypropylene known to those skilled in the art may be used. In the present invention, the organic solvent is preferably one or more selected from the group consisting of toluene, xylene and decalin. In the invention, the temperature of polypropylene dissolved in an organic solvent is preferably 100-120 ℃; the concentration of polypropylene in the polypropylene solution is preferably 100-125 g/L; the stirring time is preferably 2-4 h, and the stirring is performed in order to uniformly mix the components.
And after obtaining the polypropylene/nano barium sulfate solution, adding the polypropylene/nano barium sulfate solution into an isometric coagulating bath for phase conversion and solidification, taking out after solidification, washing, and drying in vacuum to obtain the polypropylene/nano barium sulfate composite material. In the present invention, the coagulation bath is preferably one selected from the group consisting of absolute ethanol and acetone.
After the polypropylene/nano barium sulfate composite material is obtained, extruding and granulating the polypropylene/nano barium sulfate composite material through a co-rotating double-screw extruder to obtain a composite biological patch raw material; in the invention, the extrusion temperature of the co-rotating twin screws is preferably 150-200 ℃, the screw rotating speed is preferably 60-120 r/min, and more preferably 60 r/min.
After the composite biological patch raw material is obtained, the composite biological patch raw material is extruded and spun by a single-screw extruder to prepare composite fibers, and the composite fibers are woven to prepare the barium sulfate-containing developable composite biological patch. In the invention, the extrusion temperature of the single-screw extruder is preferably 150-220 ℃, and more preferably 220 ℃.
For further understanding of the present invention, the composite biological patch containing barium sulfate developable and the preparation method thereof provided by the present invention are described in detail below with reference to the following examples, and the scope of the present invention is not limited by the following examples.
Example 1:
adding 80mL of toluene and 10g of polypropylene (accounting for 85 percent of the mass of the polypropylene/nano barium sulfate composite material) into a reaction kettle, stirring and dissolving, wherein the stirring speed of the reaction kettle is 200r/min, and simultaneously heating the reaction kettle to 100 ℃. After the polypropylene is completely dissolved, 1.7647g of nano barium sulfate powder (accounting for 15 percent of the mass of the polypropylene/nano barium sulfate composite material) is added into the reaction kettle, and the average particle size of the nano barium sulfate powder is 70 nm. And after the addition is finished, stirring for 2 hours continuously until the nano barium sulfate powder and the polypropylene are fully and uniformly mixed. The polypropylene/nano barium sulfate solution was then slowly poured into 80mL of anhydrous ethanol coagulation bath with stirring at 30 r/min. And then carrying out twin-screw extrusion granulation on the polypropylene/nano barium sulfate composite material to obtain a composite biological patch raw material, wherein the temperature range of an extruder is 150-200 ℃, and the rotating speed of a screw is 60 r/min. The raw material particles are subjected to single-screw melt spinning to obtain the composite fiber, and the spinning temperature is 220 ℃. The composite fiber is woven to obtain the biological patch with the thickness of 0.6mm and the pore space of 2 mm.
The weight of the patch is 82g/m through testing2Tensile strength of 1275 mmHg; the composite biological patch is developed clearly through X-ray examination.
Example 2:
adding 90mL of toluene and 10g of polypropylene (accounting for 75 percent of the mass of the polypropylene/nano barium sulfate composite material) into a reaction kettle, stirring and dissolving, wherein the stirring speed of the reaction kettle is 200r/min, and simultaneously heating the reaction kettle to 100 ℃. After the polypropylene is completely dissolved, 3.3333g of nano barium sulfate powder (accounting for 25 percent of the mass of the polypropylene/nano barium sulfate composite material) is added into the reaction kettle, and the average particle size of the nano barium sulfate powder is 70 nm. And after the addition is finished, stirring for 2 hours continuously until the nano barium sulfate powder and the polypropylene are fully and uniformly mixed. The polypropylene/nano barium sulfate solution was then slowly poured into a 90mL absolute ethanol coagulation bath with a stirring rate of 30 r/min. And then carrying out twin-screw extrusion granulation on the polypropylene/nano barium sulfate composite material to obtain a composite biological patch raw material, wherein the temperature range of an extruder is 150-200 ℃, and the rotating speed of a screw is 60 r/min. The raw material particles are subjected to single-screw melt spinning to obtain the composite fiber, and the spinning temperature is 220 ℃. The composite fiber is woven to obtain the biological patch with the thickness of 0.6mm and the pore space of 2 mm.
The weight of the patch is tested to be 84g/m2Tensile strength of 1065 mmHg; the composite biological patch is developed clearly through X-ray examination.
Example 3:
100mL of toluene and 10g of polypropylene (accounting for 65 percent of the mass of the polypropylene/nano barium sulfate composite material) are added into a reaction kettle for stirring and dissolving, the stirring speed of the reaction kettle is 200r/min, and the reaction kettle is heated to 100 ℃. After the polypropylene is completely dissolved, 5.3846g of nano barium sulfate powder (accounting for 35 percent of the mass of the polypropylene/nano barium sulfate composite material) is added into the reaction kettle, and the average particle size of the nano barium sulfate powder is 70 nm. And after the addition is finished, stirring for 2 hours continuously until the nano barium sulfate powder and the polypropylene are fully and uniformly mixed. The polypropylene/nano barium sulfate solution was then slowly poured into a 100mL absolute ethanol coagulation bath with a stirring rate of 30 r/min. And then carrying out twin-screw extrusion granulation on the polypropylene/nano barium sulfate composite material to obtain a composite biological patch raw material, wherein the temperature range of an extruder is 150-200 ℃, and the rotating speed of a screw is 60 r/min. The raw material particles are subjected to single-screw melt spinning to obtain the composite fiber, and the spinning temperature is 220 ℃. The composite fiber is woven to obtain the biological patch with the thickness of 0.6mm and the pore space of 2 mm.
The weight of the patch is 86g/m by testing2Tensile strength of 820 mmHg; the composite biological patch is developed clearly through X-ray examination.
Comparative example 1:
adding 80mL of toluene and 10g of polypropylene (accounting for 90 percent of the mass of the polypropylene/nano barium sulfate composite material) into a reaction kettle, stirring and dissolving, wherein the stirring speed of the reaction kettle is 200r/min, and simultaneously heating the reaction kettle to 100 ℃. After the polypropylene is completely dissolved, 1.1111g of nano barium sulfate powder (accounting for 10 percent of the mass of the polypropylene/nano barium sulfate composite material) is added into the reaction kettle, and the average particle size of the nano barium sulfate powder is 70 nm. And after the addition is finished, stirring for 2 hours continuously until the nano barium sulfate powder and the polypropylene are fully and uniformly mixed. The polypropylene/nano barium sulfate solution was then slowly poured into 80mL of anhydrous ethanol coagulation bath with stirring at 30 r/min. And then carrying out twin-screw extrusion granulation on the polypropylene/nano barium sulfate composite material to obtain a composite biological patch raw material, wherein the temperature range of an extruder is 150-200 ℃, and the rotating speed of a screw is 60 r/min. The raw material particles are subjected to single-screw melt spinning to obtain the composite fiber, and the spinning temperature is 220 ℃. The composite fiber is woven to obtain the biological patch with the thickness of 0.6mm and the pore space of 2 mm.
The weight of the patch is 81g/m through testing2A tensile strength of 1340 mmHg; the composite biological patch is not clearly developed through X-ray inspection.
Comparative example 2:
100mL of toluene and 10g of polypropylene (accounting for 60 percent by mass of the polypropylene/nano barium sulfate composite material) are added into a reaction kettle, stirred and dissolved, the stirring speed of the reaction kettle is 200r/min, and simultaneously the temperature of the reaction kettle is raised to 100 ℃. After the polypropylene is completely dissolved, 6.6666g of nano barium sulfate powder (accounting for 40 percent of the mass of the polypropylene/nano barium sulfate composite material) is added into the reaction kettle, and the average particle size of the nano barium sulfate powder is 70 nm. And after the addition is finished, stirring for 2 hours continuously until the nano barium sulfate powder and the polypropylene are fully and uniformly mixed. The polypropylene/nano barium sulfate solution was then slowly poured into a 100mL absolute ethanol coagulation bath with a stirring rate of 30 r/min. And then carrying out twin-screw extrusion granulation on the polypropylene/nano barium sulfate composite material to obtain a composite biological patch raw material, wherein the temperature range of an extruder is 150-200 ℃, and the rotating speed of a screw is 60 r/min. The raw material particles are subjected to single-screw melt spinning to obtain the composite fiber, and the spinning temperature is 220 ℃. The composite fiber is woven to obtain the biological patch with the thickness of 0.6mm and the pore space of 2 mm.
The weight of the patch is 90g/m by testing2A tensile strength of 530 mmHg; the composite biological patch is developed clearly through X-ray examination.
The barium sulfate content, patch weight, thickness, porosity, tensile strength and development strength in the composite biological patch materials of examples 1-3 and comparative examples 1-2 are shown in table 1. It can be seen from the examples and comparative examples that when the mass percentage of barium sulfate is less than 15%, the development strength of the material is not clear, and when the mass percentage of sulfuric acid is more than 35%, the mechanical properties of the material are significantly reduced.
TABLE 1
The invention provides a composite biological patch and a preparation method of raw materials thereof, which can be used for judging whether the biological patch is distorted or not through X-ray examination, simplifying a method for judging a lesion after hernia repair, improving the judgment efficiency, relieving the pain of a patient and meeting the clinical practical application.
While there have been shown and described what are at present considered the fundamental principles and essential features of the invention and its advantages, it will be apparent to those skilled in the art that the invention is not limited to the details of the foregoing exemplary embodiments, but is capable of other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (10)
1. The barium sulfate-containing developable composite biological patch is characterized by comprising the following components in percentage by mass: 65-85% of polypropylene and 15-35% of nano barium sulfate.
2. The barium sulfate-containing developable composite bioprosthetic patch of claim 1, wherein the composite bioprosthetic patch has a thickness of 0.6mm and a pore size of 2 mm.
3. The barium sulfate-containing developable composite biological patch according to claim 1, wherein the polypropylene is medical grade isotactic polypropylene, the melting point is 164-170 ℃, and the isotactic index is not less than 96%.
4. The barium sulfate-containing developable composite biological patch according to claim 1, wherein the nano barium sulfate has a particle size ranging from 30 to 70 nm.
5. A method for preparing the barium sulfate-containing developable composite biological patch according to any one of claims 1 to 4, characterized by comprising the following steps:
(1) dissolving polypropylene in an organic solvent to obtain a polypropylene solution, adding nano barium sulfate into the polypropylene solution, and stirring until the nano barium sulfate and the nano barium sulfate are uniformly mixed to obtain a polypropylene/nano barium sulfate solution;
(2) adding the polypropylene/nano barium sulfate solution obtained in the step (1) into a coagulating bath with the same volume for phase conversion and solidification, taking out after solidification, washing, and drying in vacuum to obtain a polypropylene/nano barium sulfate composite material;
(3) extruding and granulating the polypropylene/nano barium sulfate composite material by a co-rotating double-screw extruder to obtain a composite biological patch raw material;
(4) and extruding and spinning the raw material of the composite biological patch by a single-screw extruder to prepare composite fibers, and weaving and processing the composite fibers to prepare the barium sulfate-containing developable composite biological patch.
6. The preparation method of the barium sulfate-containing developable composite biological patch according to claim 5, characterized in that the organic solvent in step (1) is one or more of toluene, xylene and decalin.
7. The preparation method of the barium sulfate-containing developable composite biological patch according to claim 5, characterized in that in the step (1), the temperature of dissolving polypropylene in the organic solvent is 100-120 ℃; the concentration of polypropylene in the polypropylene solution is 100-125 g/L; the stirring time is 2-4 h.
8. The method for preparing a barium sulfate-containing developable composite biological patch according to claim 5, wherein the coagulation bath in step (2) comprises one of absolute ethyl alcohol or acetone.
9. The preparation method of the barium sulfate-containing developable composite biological patch according to claim 5, characterized in that the extrusion temperature in the step (3) is 150-200 ℃; the rotating speed of the screw is 60-120 r/min.
10. The preparation method of the barium sulfate-containing developable composite biological patch according to claim 5, characterized in that the extrusion temperature in the step (4) is 150-220 ℃.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910874175.8A CN110522954B (en) | 2019-09-17 | 2019-09-17 | Barium sulfate-containing developable composite biological patch and preparation method thereof |
| AU2020348320A AU2020348320B2 (en) | 2019-09-17 | 2020-06-15 | Developable composite biological mesh containing barium sulfate and preparation method therefor |
| PCT/CN2020/096114 WO2021051902A1 (en) | 2019-09-17 | 2020-06-15 | Developable composite biological mesh containing barium sulfate and preparation method therefor |
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| CN201910874175.8A CN110522954B (en) | 2019-09-17 | 2019-09-17 | Barium sulfate-containing developable composite biological patch and preparation method thereof |
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| CN110522954A CN110522954A (en) | 2019-12-03 |
| CN110522954B true CN110522954B (en) | 2021-12-10 |
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| CN111979599A (en) * | 2020-08-06 | 2020-11-24 | 南通大学 | Preparation method of barium-containing developable functional polypropylene fiber |
| CN113549257B (en) * | 2021-08-18 | 2022-04-12 | 南通大学 | Developable traceable one-dimensional password material and preparation method and application thereof |
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| US9427297B2 (en) * | 2008-05-09 | 2016-08-30 | Boston Scientific Scimed, Inc. | Surgical meshes with radiopaque coatings |
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| KR20170112018A (en) * | 2016-03-30 | 2017-10-12 | 주식회사 인성메디칼 | Method For Manufacturing Catheter With Antimicrobial Property |
| US11883565B2 (en) * | 2017-03-17 | 2024-01-30 | Gyrus Acmi, Inc. | Ureteral stent |
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