CN109481741B - Nano composite anti-adhesion hernia repair patch and preparation method thereof - Google Patents
Nano composite anti-adhesion hernia repair patch and preparation method thereof Download PDFInfo
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- CN109481741B CN109481741B CN201811480425.1A CN201811480425A CN109481741B CN 109481741 B CN109481741 B CN 109481741B CN 201811480425 A CN201811480425 A CN 201811480425A CN 109481741 B CN109481741 B CN 109481741B
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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
- A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L31/129—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing macromolecular fillers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
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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
- A61L31/146—Porous materials, e.g. foams or sponges
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- D—TEXTILES; PAPER
- D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
- D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
- D01D5/00—Formation of filaments, threads, or the like
- D01D5/0007—Electro-spinning
- D01D5/0061—Electro-spinning characterised by the electro-spinning apparatus
- D01D5/0076—Electro-spinning characterised by the electro-spinning apparatus characterised by the collecting device, e.g. drum, wheel, endless belt, plate or grid
- D01D5/0084—Coating by electro-spinning, i.e. the electro-spun fibres are not removed from the collecting device but remain integral with it, e.g. coating of prostheses
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- D—TEXTILES; PAPER
- D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
- D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
- D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
- D04H1/70—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres
- D04H1/72—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres the fibres being randomly arranged
- D04H1/728—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres the fibres being randomly arranged by electro-spinning
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
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- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Epidemiology (AREA)
- Surgery (AREA)
- Chemical & Material Sciences (AREA)
- Textile Engineering (AREA)
- Cardiology (AREA)
- Composite Materials (AREA)
- Mechanical Engineering (AREA)
- Materials Engineering (AREA)
- Oral & Maxillofacial Surgery (AREA)
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- Dispersion Chemistry (AREA)
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Abstract
The invention relates to a nano composite anti-adhesion hernia repair patch and a preparation method thereof, wherein the preparation method comprises the following steps: the warp knitting mesh patch and the nanofiber membrane are compounded through electrostatic spinning to prepare the nano composite anti-adhesion hernia repair patch, wherein electrostatic spinning liquid for electrostatic spinning mainly comprises collagen, PEO, hexafluoroisopropanol and acetic acid, and the warp knitting mesh patch is made of polypropylene, polyvinylidene fluoride or expanded polytetrafluoroethylene. The prepared nano composite anti-adhesion hernia repair patch has a composite layer structure and comprises a warp knitting mesh patch layer and a nano fiber membrane layer which are adjacent, wherein the thickness of the nano fiber membrane is 0.7-1.8 mu m, and the diameter of fibers in the nano fiber membrane is 254-597 nm. The preparation method of the invention does not need adhesive, has simple process, no toxic and harmful substances, safety, environmental protection and low cost; the nano composite anti-adhesion hernia repair patch prepared by the invention has excellent anti-adhesion performance and mechanical performance, good biocompatibility and good market prospect.
Description
Technical Field
The invention belongs to the technical field of processing of new biomedical textile products, and relates to a nano-composite anti-adhesion hernia repair patch and a preparation method thereof.
Background
The biomedical textile is a textile which is based on fibers and fabrics and applied to medical, protective, health care and sanitary purposes, and is one of the varieties with the strongest creativity and the highest technological content in industrial textiles. The hernia repair patch serving as a medical textile has high research value and application prospect, but the currently clinically used hernia repair patch still has some problems, such as poor anti-adhesion effect, which directly influences the postoperative repair condition. Therefore, the improvement of the anti-adhesion effect of the hernia repair patch is an inevitable requirement.
The industry has now made much research in this regard. Patent CN101579540A discloses an anti-adhesion hernia repair patch and a preparation method thereof, which comprises the following preparation steps: (1) preparing the chitosan anti-adhesion upper piece: the anti-adhesion chitosan upper piece is prepared by taking water-soluble chitosan as a main raw material and glycerol as a matching agent by a tape casting pressure method, wherein the weight percentage of the anti-adhesion chitosan upper piece comprises 0.5-10% of water-soluble chitosan, 0-10% of glycerol and 80-98% of water; (2) and (3) laminating: uniformly coating a layer of chitosan mucilage on the polypropylene woven mesh, and then placing the chitosan anti-adhesion upper sheet on the polypropylene woven mesh for pressing; (3) and (3) post-treatment: and (3) placing the pressed mesh between moulds, and drying the mesh by a film isolation method at-15-150 ℃ under the environment of 0-0.6 MPa to obtain the anti-adhesion hernia repair patch. Although the prepared anti-adhesion hernia repair patch can prevent postoperative adhesion to a certain extent, the mechanical property is poor, and the anti-adhesion effect still has a large improvement space. Patent CN102302800A discloses a chitosan film-hanging polypropylene mesh and a preparation method thereof, wherein the preparation method comprises the following steps: (1) preparing a chitosan casting solution: dissolving a certain amount of chitosan in 1-3% acetic acid solution, adding glutaraldehyde and n-heptane into the solution, performing crosslinking reaction for 0.5-1.5 hours at the temperature of 45-50 ℃ under stirring, and standing to obtain a chitosan casting solution with the mass content of chitosan of 1-5%; (2) soaking a clean polypropylene mesh in the casting solution prepared in the step (1) until a layer of chitosan film is coated on the polypropylene mesh to prepare a chitosan film-hanging polypropylene mesh; (3) and (3) post-treatment: firstly, washing with 5-15% sodium hydroxide alkali solution, and then repeatedly washing with deionized water until the washing liquid is neutral, thereby washing the chitosan biofilm polypropylene mesh. Although the chitosan film-forming polypropylene mesh prepared by the method does not contain toxic components, has good biocompatibility and can improve tissue adhesion to a certain extent, the process of coating the film is complex and needs to be repeatedly soaked and dried in the sun. Patent CN105708581A discloses an electrostatic spinning film-coated composite pelvic floor patch and a preparation method thereof, wherein the preparation method comprises the following steps: (1) preparation of a polypropylene mesh patch: weaving medical polypropylene monofilaments with the diameter of 0.05-0.1 mm on a Raschel warp knitting machine, washing, naturally drying, then performing heat setting, naturally cooling, and cutting to obtain polypropylene warp-knitted mesh patches; (2) preparing a spinning solution: mixing 5-8% by mass of polylactic acid and polycaprolactone, dissolving the mixture in a mixed solvent of dichloromethane DCM and dimethylformamide DMF, wherein the mass ratio of DCM to DMF is 4:1, and then heating and stirring to obtain a spinning solution; (3) spinning: brushing one surface of the polypropylene warp-knitted mesh patch in the step (1) with a layer of fluororubber-acetone adhesive, attaching the other surface of the polypropylene warp-knitted mesh patch to an aluminum box serving as an electrostatic spinning receiving device, and performing electrostatic spinning by using the spinning solution in the step (2), wherein the electrostatic spinning process comprises the following steps: 2-3 ml of polylactic acid/polycaprolactone solution is extracted by adopting a 5ml syringe and is placed on a propeller, the voltage is set to be 12kV, the flow rate is 0.6ml/h, the receiving distance is 15cm, and the collecting time is 3-4 h; (4) and (3) post-treatment: and volatilizing the spun composite patch for 12-48 h, and then sterilizing by adopting ethylene oxide to obtain the electrostatic spinning film-coated composite pelvic floor patch. Although the patch prepared by the method has excellent mechanical property, good biocompatibility and excellent anti-adhesion performance, the polycaprolactone contained in the patch has certain harm to human bodies. Patent CN105596112A discloses a special abdominal hernia repair mesh for open surgery, which is prepared by the following steps: (1) treating a base material: soaking the polypropylene mesh into the absorbable coating solution, and drying to obtain the polypropylene mesh with the surface coated with the polypropylene cross-caprolactone copolymer (PLCL) absorbable coating; (2) preparing a film layer: pouring an absorbable coating solution into the mold, standing and volatilizing to obtain an absorbable PLCL film; (3) compounding: heating and pressing the polypropylene mesh sheet with the surface coated with the absorbable coating prepared in the step (1) on the absorbable film layer prepared in the step (2), standing for volatilization, and heating for fusion; (4) punching drainage holes on the absorbable film layer; (5) turning over: and sewing, heat sealing or ultrasonically welding the patch after pressing to form the positioning bag. Although the polypropylene and the anti-adhesion film in the hernia repair mesh can be completely embedded without obvious boundary surface and no layering phenomenon, the anti-adhesion film can effectively prevent adhesion, and simultaneously has excellent mechanical performance, the structural integrity of the anti-adhesion film of the hernia repair mesh is poor, and the retention time for preventing adhesion is short.
Therefore, the development of the hernia repair patch which has excellent mechanical performance and anti-adhesion performance, is safe and has long anti-adhesion retention time is of practical significance.
Disclosure of Invention
The invention aims to provide a nano-composite anti-adhesion hernia repair patch which has excellent mechanical property and anti-adhesion property, is safe and has long anti-adhesion retention time and a preparation method thereof, aiming at the defects of poor mechanical property, poor safety to human bodies, poor anti-adhesion property and short anti-adhesion retention time in the prior art. According to the invention, the warp knitting mesh patch (basic patch) is compounded with the nanofiber membrane through electrostatic spinning, the nanofiber membrane prepared through electrostatic spinning has high porosity and large specific surface area, and is beneficial to cell growth, and collagen in electrostatic spinning solution for electrostatic spinning is easy to degrade, good in biocompatibility and good in anti-adhesion performance, and cannot generate adverse effects on cell growth. In addition, the structure of the warp-knitted mesh patch is optimized and subjected to heat setting treatment, so that the mechanical performance of the nano-composite anti-adhesion hernia repair patch is remarkably improved.
In order to achieve the purpose, the invention adopts the following technical scheme:
a preparation method of a nano-composite anti-adhesion hernia repair patch comprises the step of compounding a warp knitting mesh patch and a nanofiber membrane through electrostatic spinning to prepare the nano-composite anti-adhesion hernia repair patch, wherein an electrostatic spinning solution for electrostatic spinning mainly comprises collagen, PEO, hexafluoroisopropanol and acetic acid. The invention adopts electrostatic spinning composition, because the nanofiber membrane prepared by electrostatic spinning has high porosity and large specific surface area, the nanofiber membrane is beneficial to cell growth, and the electrostatic spinning process is simple.
As a preferred technical scheme:
according to the preparation method of the nano-composite anti-adhesion hernia repair patch, the material of the warp knitting mesh patch is polypropylene, polyvinylidene fluoride or expanded polytetrafluoroethylene. The material of the warp-knitted mesh patch of the present invention is not limited thereto, and only some possible materials are listed here, and those skilled in the art can select the material according to actual needs.
According to the preparation method of the nanocomposite anti-adhesion hernia repair patch, the warp knitting mesh patch is a satin weave, and the knitting warp feeding amount: GB1 is 2750 +/-50 mm/rack, GB2 is 2350 +/-50 mm/rack, and the mesh shape is rhombic;
the warp knitting mesh patch is a warp flat and satin compound tissue, and the knitting let-off amount is as follows: GB1 is 2300 + -50 mm/rack, GB2 is 2250 + -50 mm/rack, and the mesh shape is hexagonal;
the warp knitting mesh patch is a variable warp flat tissue, and the knitting warp feeding amount: GB1 is 2880 + -50 mm/rack, GB2 is 2650 + -50 mm/rack, and the mesh shape is circular.
GB1 shows the let-off of the first guide bar during knitting, and GB2 shows the let-off of the second guide bar during knitting;
the tissue structures with different mesh shapes not only influence the mechanical property of the nano composite anti-adhesion hernia repair patch, but also influence the growth of cells. GB1 and GB2 need to be controlled within a certain range, otherwise, the stitch looping of the tissues during weaving can be influenced, and the required patch can not be formed.
According to the preparation method of the nanocomposite anti-adhesion hernia repair patch, the warp knitting mesh patch is a polypropylene mesh after heat setting treatment. By carrying out heat setting treatment on the polypropylene mesh, the stability of the structure and the size of polypropylene can be improved, and the physical and mechanical properties of the polypropylene are improved.
According to the preparation method of the nanocomposite anti-adhesion hernia repair patch, the heat setting temperature is 120-140 ℃, the time is 8-12 min, the longitudinal elongation of the polypropylene mesh during heat setting is 0-8.6%, and the transverse elongation of the polypropylene mesh is 0-6.41%;
the polypropylene mesh is formed by warp knitting polypropylene monofilaments, wherein the polypropylene monofilaments are medical polypropylene monofilaments, the diameter of the medical polypropylene monofilaments is 0.152 +/-0.005 mm, the warp knitting drawing density is 10 +/-2 courses/cm, and the breadth is 0.5-1 m. The too large diameter of the polypropylene monofilament can cause the aperture of the mesh in the patch to be reduced, thereby influencing the growth of cells; too small a diameter may weaken the mechanical properties of the monofilament and the patch. Variations in draw density can change the mesh size and mechanical properties in the patch.
According to the preparation method of the nanocomposite anti-adhesion hernia repair patch, the electrostatic spinning solution is prepared by mixing collagen and PEO, dissolving the mixture in a mixed solvent of hexafluoroisopropanol and acetic acid, and stirring.
According to the preparation method of the nano-composite anti-adhesion hernia repair patch, the mass ratio of collagen to PEO is 70-90: 30-10, the volume ratio of hexafluoroisopropanol to acetic acid is 1:1, the total concentration of solutes (collagen and PEO) in the electrostatic spinning solution is 3-7.5 wt%, the stirring is magnetic stirring, the stirring time is 24 hours, and the stirring speed is 400 r/min. The mass ratio of collagen to PEO is too small, so that the fiber filaments cannot be spun, the total solute concentration of the electrostatic spinning solution needs to be controlled within a certain range, otherwise, the fiber filaments are influenced, and even the fiber filaments cannot be formed.
According to the preparation method of the nanocomposite anti-adhesion hernia repair patch, the electrostatic spinning process parameters are as follows: the voltage is 8-16 kV, and the receiving distance is 16-24 cm. The voltage can be adjusted within a certain range, but should not be too high, otherwise the fibers cannot be spun, the receiving distance can also be adjusted according to the requirements, but should not be too high, otherwise the fibers cannot be spun on the receiving screen.
The invention also provides the nano composite anti-adhesion hernia repair patch prepared by the preparation method of the nano composite anti-adhesion hernia repair patch, which has a composite layer structure and comprises adjacent warp knitting mesh patch layers and a nano fiber membrane layer. The warp knitting mesh patch layer and the nanofiber membrane layer of the nano-composite anti-adhesion hernia repair patch are completely embedded, no obvious boundary surface exists, the layering phenomenon cannot occur, and meanwhile, the nanofiber membrane layer is good in structural integrity and long in anti-adhesion effect retention time.
As a preferred technical scheme:
according to the nano-composite anti-adhesion hernia repair patch, the thickness of the warp-knitted mesh patch is 0.5524-0.8169 mm, the thickness of the nanofiber membrane is 0.7-1.8 mu m, and the diameter of fibers in the nanofiber membrane is 254-597 nm.
The invention mechanism is as follows:
the warp-knitted mesh patch is compounded with the nanofiber membrane through electrostatic spinning, because the nanofiber membrane prepared through electrostatic spinning has high porosity and large specific surface area, cell growth is facilitated, and meanwhile, the process of electrostatic spinning is simple.
Collagen and PEO in the electrostatic spinning solution are solute components, and the collagen/PEO nanofiber is prepared by spinning the electrostatic spinning solution, wherein the collagen is used as an anti-adhesion component, and the PEO can improve the spinnability of the nanofiber on one hand, enhance the strength of the nanofiber on the other hand, and overcome the defect of low strength of the collagen fiber.
The nanofiber membrane prepared by the invention is anti-adhesion and can be compounded with the warp-knitted mesh patch without an adhesive, the strength and anti-adhesion performance of the nanofiber are improved by selecting a specific material for electrostatic spinning, and meanwhile, the nanofiber membrane is matched with the warp-knitted mesh patch with a specific tissue structure and a mesh shape, so that the nanofiber is uniformly distributed and fixed on tissue, the structural integrity of the nanofiber membrane is ensured to be good, and the retention time of the anti-adhesion effect of the nanocomposite anti-adhesion hernia repair patch is remarkably prolonged.
In addition, the warp-knitted mesh patch with a specific structure is selected and subjected to heat setting treatment, so that the stability of the structure and the size is good, and the physical and mechanical properties of the nano-composite anti-adhesion hernia repair patch can be improved.
Has the advantages that:
(1) the nano-composite anti-adhesion hernia repair patch has excellent anti-adhesion performance and mechanical performance, good biocompatibility and good market prospect;
(2) the preparation method of the nano-composite anti-adhesion hernia repair patch provided by the invention does not need an adhesive, is simple in process, free of toxic and harmful substances, safe and environment-friendly, low in cost and extremely wide in application prospect.
Drawings
Fig. 1 is a schematic structural diagram of a nanocomposite anti-adhesion hernia repair patch made from a warp-knitted mesh patch of a satin weave structure according to the present invention;
fig. 2 is a schematic structural diagram of a nanocomposite anti-adhesion hernia repair patch prepared from a warp-knitted mesh patch of a warp plain and warp satin composite weave according to the present invention;
fig. 3 is a schematic structural diagram of a nanocomposite anti-adhesion hernia repair patch made from a warp-knitted mesh patch of varying warp-flat texture according to the present invention;
FIG. 4 is a diagram of the motion of the inlay yarn of a warp knitted mesh patch of the warp satin stitch construction of the present invention;
FIG. 5 is a motion diagram of a warp knitted mesh patch fill yarn of the warp flat and warp satin compound stitch of the present invention;
FIG. 6 is a diagram of the warp knit mesh patch fill motion of a varying warp knit of the present invention;
FIG. 7 is an SEM image of cells cultured for 60min after the nanocomposite anti-adhesion hernia repair patch prepared in example 1 is prepared;
FIG. 8 is an SEM image of cells cultured for 60min after the nanocomposite anti-adhesion hernia repair patch prepared in example 37 is prepared;
FIG. 9 is an SEM image of cells cultured for 60min after the nanocomposite anti-adhesion hernia repair patch prepared in example 73 is prepared;
FIG. 10 is an SEM image of cells cultured for 120min after the nanocomposite anti-adhesion hernia repair patch prepared in example 1 is prepared;
FIG. 11 is an SEM image of cells cultured for 120min after the nanocomposite anti-adhesion hernia repair sheet prepared in example 37 is prepared;
FIG. 12 is an SEM image of cells cultured for 120min after the nanocomposite anti-adhesion hernia repair sheet prepared in example 73 is prepared;
FIG. 13 is an SEM image of cells cultured for 240min after the nanocomposite anti-adhesion hernia repair patch prepared in example 1 is prepared;
FIG. 14 is an SEM image of cells cultured for 240min after the nanocomposite anti-adhesion hernia repair patch prepared in example 37 is prepared;
FIG. 15 is an SEM image of cells cultured for 240min after the nanocomposite anti-adhesion hernia repair patch prepared in example 73 is prepared;
wherein, 1 is a warp knitting mesh patch, and 2 is a nano fiber film.
Detailed Description
The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications of the present invention may be made by those skilled in the art after reading the teaching of the present invention, and such equivalents may fall within the scope of the present invention as defined in the appended claims.
Examples 1 to 108
A preparation method of a nano composite anti-adhesion hernia repair patch comprises the following steps:
(1) warp knitting is carried out on medical grade polypropylene monofilaments to obtain polypropylene warp knitting mesh patches, wherein the diameter of each polypropylene monofilament is 0.152mm, the drawing density of warp knitting is 10 courses/cm, the width of each warp knitting is 1m, the tissue structure of each polypropylene warp knitting mesh patch is detailed in table 1, and the thickness of each polypropylene warp knitting mesh patch is 0.5524-0.8169 mm;
(2) then, carrying out heat setting treatment on the polypropylene warp-knitted mesh patch, wherein the conditions of the heat setting treatment are detailed in table 1;
(3) mixing collagen and PEO, dissolving the mixture in a mixed solvent of hexafluoroisopropanol and acetic acid, and magnetically stirring the mixture for 24 hours at a rotating speed of 400r/min to prepare an electrostatic spinning solution, wherein the mass ratio of the collagen to the PEO is 70:30, the volume ratio of the hexafluoroisopropanol to the acetic acid is 1:1, and the total solute concentration of the electrostatic spinning solution is 6 wt%;
(4) and (3) taking the solution obtained in the step (3) as an electrostatic spinning solution, taking the polypropylene warp-knitted mesh patch subjected to heat setting treatment in the step (2) as a receiving base material, and performing electrostatic spinning on the surface of the receiving base material to form a nano composite fiber membrane to prepare the nano composite anti-adhesion hernia repair patch, wherein the electrostatic spinning process parameters are as follows: the voltage was 12kV and the reception distance was 20 cm.
The prepared nano composite anti-adhesion hernia repair patch has a 2-layer structure and comprises a polypropylene warp-knitted mesh patch layer and a nanofiber membrane layer which are adjacent, wherein the thickness of the nanofiber membrane is 1.0 mu m, the diameter of fibers in the nanofiber membrane is 597nm, and the bending rigidity, the tensile strength, the bursting strength, the tearing strength and the suture tensile strength of the prepared nano composite anti-adhesion hernia repair patch are detailed in table 1.
TABLE 1
In the above table:
"-" indicates not measured;
as shown in fig. 1 and 4, when the polypropylene warp knitted mesh patch is a satin weave, its knitting let-off amount: GB1 is 2743mm/rack, GB2 is 2353mm/rack, and the mesh shape is diamond;
as shown in fig. 2 and 5, when the polypropylene warp knitted mesh patch is a composite structure of warp flat and warp satin, the knitting let-off amount: GB1 is 2300mm/rack, GB2 is 2250mm/rack, and the mesh shape is hexagonal;
as shown in fig. 3 and 6, when the polypropylene warp knitted mesh patch is a varying warp flat structure, the knitting let-off amount thereof: GB1 is 2880mm/rack, GB2 is 2650mm/rack, the mesh shape is circular, wherein, FIGS. 4-6 are knitting needle motion diagrams of the warp knitting mesh patch during warp knitting;
the temperature provided in the heat-setting conditions was the temperature for heat-setting and the time provided was the time for the heat-setting treatment, "high tension" means 8.6% elongation in the machine direction and 6.41% elongation in the cross direction of the polypropylene warp-knitted mesh patch at the heat-setting, low tension means 3.23% elongation in the machine direction and 2.56% elongation in the cross direction of the polypropylene warp-knitted mesh patch at the heat-setting, and "no tension" means 0% elongation in the machine direction and 0% elongation in the cross direction of the polypropylene warp-knitted mesh patch at the heat-setting;
the bending rigidity, the tensile strength, the bursting strength, the tearing strength and the suture tensile strength are respectively expressed by units of none, N, N, N and N;
"plus" means the front side of the patch, "minus" means the back side of the patch, "cross-row" means in the cross-machine direction of the patch, and "wale" means in the machine direction of the patch.
The obtained nanocomposite anti-adhesion hernia repair patch is further tested, and mainly comprises the following steps:
(1) the cytotoxicity of the nanocomposite anti-adhesion hernia repair patch and the growth condition of cells on the nanocomposite anti-adhesion hernia repair patch are tested by adopting a cell culture method, which comprises the following steps:
the same fibroblasts (NIH3T3) were placed on the nanocomposite anti-adhesion hernia repair patch (including a repair patch prepared by using polypropylene warp knitted mesh patches of different tissue structures as a base material) and the polypropylene warp knitted mesh patch, and were used as an experimental group and a blank control group, respectively, and were cultured for 7 days in the same environment (a dmem complete culture solution prepared by using a high-sugar dmem medium, fetal bovine serum, penicillin, and streptomycin in a mass ratio of 90:10:1: 1), and then cytotoxicity assays were performed on days 1, 2, 3, and 7 using CCK-8 kits, respectively, and the absorbance average values of the experimental group and the blank control group were measured, respectively, and the results are shown in table 2:
TABLE 2
In the table, "satin" represents the nanocomposite anti-adhesion hernia repair patch prepared in example 1, "tricot flat and satin composite" represents the nanocomposite anti-adhesion hernia repair patch prepared in example 37, "changed tricot flat" represents the nanocomposite anti-adhesion hernia repair patch prepared in example 73, and "blank" represents the polypropylene warp-knitted mesh patch prepared in step (1) of example 1.
Comparing the absorbance average values of the experimental group and the blank control group, wherein the absorbance average value of the experimental group is basically higher than 80% of the absorbance average value of the control group, and the material is proved to be non-toxic to cells.
(3) The same fibroblast (NIH3T3) cells were placed on the nanocomposite anti-adhesion hernia repair patch prepared in example 1, the nanocomposite anti-adhesion hernia repair patch prepared in example 37, and the nanocomposite anti-adhesion hernia repair patch prepared in example 73, respectively, and SEM images of the nanocomposite anti-adhesion hernia repair patch after cell culture for 60min, 120min, and 240min were taken during culturing for 4h in a dmem complete culture solution prepared with a high sugar dmem medium, fetal bovine serum, penicillin, and streptomycin in a mass ratio of 90:10:1:1, respectively, as shown in fig. 7 to 15, it was confirmed from the SEM images that after 60min of composite culture, very little adhesion was exhibited, and the cells were in an aggregated state, because the cells were not easily attached to the membrane, while the structure of the nanocomposite hernia repair patch was disadvantageous and the anti-adhesion cells grew, and when the culturing time was 120 and 240min, the number of cells is relatively increased, the growth of the cells can be seen in the nanopores, the roots of the cells are wound on the nanofiber membrane, part of the cells migrate from the gaps to the inside, and the adhesion quantity of the cells on the three structures is small, so that the conclusion that the collagen/PE membrane has a good effect of preventing cell adhesion and the effect of preventing adhesion by using a satin tissue structure as base cloth is better can be drawn.
The adhesion of cells on the repair pieces prepared from the warp-knitted mesh patches with different tissue structures is not enough, and the nano-composite anti-adhesion hernia repair piece prepared by the invention has a certain anti-adhesion effect.
Example 110
A preparation method of a nano composite anti-adhesion hernia repair patch comprises the following steps:
(1) warp knitting is carried out on medical grade polypropylene monofilaments to obtain polypropylene warp knitting mesh patches, wherein the diameter of each polypropylene monofilament is 0.150mm, the drawing density of warp knitting is 12 courses/cm, the width of each warp knitting is 0.8m, the thickness of each polypropylene warp knitting mesh patch is 0.60mm, each polypropylene warp knitting mesh patch is a satin tissue, and the knitting let-off amount of each polypropylene warp knitting mesh patch is as follows: GB1 is 2800mm/rack, GB2 is 2400mm/rack, and the mesh shape is diamond;
(2) then, the polypropylene warp-knitted mesh patch is subjected to heat setting treatment, and the conditions of the heat setting treatment are the same as those of the example 5;
(3) mixing collagen and PEO, dissolving the mixture in a mixed solvent of hexafluoroisopropanol and acetic acid, and magnetically stirring the mixture for 24 hours at a rotating speed of 400r/min to prepare an electrostatic spinning solution, wherein the mass ratio of the collagen to the PEO is 80:20, the volume ratio of the hexafluoroisopropanol to the acetic acid is 1:1, and the total solute concentration of the electrostatic spinning solution is 4.5 wt%;
(4) and (3) taking the solution obtained in the step (3) as an electrostatic spinning solution, taking one surface of the polypropylene warp-knitted mesh patch subjected to the heat setting treatment in the step (2) as a receiving base material, and performing electrostatic spinning on the surface of the receiving base material to form a nano composite fiber membrane, wherein the electrostatic spinning process parameters are as follows: the voltage was 8kV and the reception distance was 24 cm.
(5) And (4) forming a nano composite fiber membrane by using the other side of the polypropylene warp-knitted mesh patch as a receiving base material by using the same electrostatic spinning method as the step (4) to prepare the nano composite anti-adhesion hernia repair patch
The prepared nano composite anti-adhesion hernia repair patch has a 3-layer structure and comprises a polypropylene warp-knitted mesh patch layer and two adjacent nanofiber membrane layers, wherein the thickness of the nanofiber membrane is 1.8 mu m, and the diameter of fibers in the nanofiber membrane is 442 nm.
The bending rigidity of the prepared nano composite anti-adhesion herniorrhaphy patch is 3.4, the tensile strength is 240N, the bursting strength is 372.5N, the tearing strength is 38.2N, and the tensile strength of the suture is 42.90N.
Example 111
A preparation method of a nano composite anti-adhesion hernia repair patch comprises the following steps:
(1) warp knitting is carried out on medical grade polypropylene monofilaments to obtain polypropylene warp knitting mesh patches, wherein the diameter of each polypropylene monofilament is 0.147mm, the drawing density of warp knitting is 12 courses/cm, the width is 0.5m, the thickness of each polypropylene warp knitting mesh patch is 0.70mm, each warp knitting mesh patch is a variable warp flat tissue, and the knitting let-off amount of each warp knitting mesh patch is as follows: GB1 is 2940mm/rack, GB2 is 2700mm/rack, and the mesh shape is circular;
(2) then the polypropylene warp-knitted mesh patch is subjected to heat setting treatment, and the conditions of the heat setting treatment are the same as those of the example 20;
(3) mixing collagen and PEO, dissolving the mixture in a mixed solvent of hexafluoroisopropanol and acetic acid, and magnetically stirring the mixture for 24 hours at a rotating speed of 400r/min to prepare an electrostatic spinning solution, wherein the mass ratio of the collagen to the PEO is 85:15, the volume ratio of the hexafluoroisopropanol to the acetic acid is 1:1, and the total solute concentration of the electrostatic spinning solution is 7.5 wt%;
(4) and (3) taking the solution obtained in the step (3) as an electrostatic spinning solution, taking the polypropylene warp-knitted mesh patch subjected to heat setting treatment in the step (2) as a receiving base material, and performing electrostatic spinning on the surface of the receiving base material to form a nano composite fiber membrane to prepare the nano composite anti-adhesion hernia repair patch, wherein the electrostatic spinning process parameters are as follows: the voltage was 16kV and the reception distance was 22 cm.
The prepared nano composite anti-adhesion hernia repair patch has a 2-layer structure and comprises a polypropylene warp-knitted mesh patch layer and a nanofiber membrane layer which are adjacent, wherein the thickness of the nanofiber membrane is 1.3 mu m, and the diameter of fibers in the nanofiber membrane is 325 nm.
The bending rigidity of the prepared nano composite anti-adhesion hernia repair patch is 3.7.
Example 112
A preparation method of a nano composite anti-adhesion hernia repair patch comprises the following steps:
(1) warp knitting is carried out on medical grade polypropylene monofilaments to obtain polypropylene warp knitting mesh patches, wherein the diameter of each polypropylene monofilament is 0.157mm, the drawing density of warp knitting is 10 courses/cm, the width is 0.5m, the thickness of each polypropylene warp knitting mesh patch is 0.65mm, each warp knitting mesh patch is a variable warp flat tissue, and the knitting let-off amount of each warp knitting mesh patch is as follows: GB1 is 2830mm/rack, GB2 is 2600mm/rack, and the mesh shape is circular;
(2) then the polypropylene warp-knitted mesh patch is subjected to heat setting treatment, and the conditions of the heat setting treatment are the same as those of the example 20;
(3) mixing collagen and PEO, dissolving the mixture in a mixed solvent of hexafluoroisopropanol and acetic acid, and magnetically stirring the mixture for 24 hours at a rotating speed of 400r/min to prepare an electrostatic spinning solution, wherein the mass ratio of the collagen to the PEO is 90:10, the volume ratio of the hexafluoroisopropanol to the acetic acid is 1:1, and the total solute concentration of the electrostatic spinning solution is 3 wt%;
(4) and (3) taking the solution obtained in the step (3) as an electrostatic spinning solution, taking the polypropylene warp-knitted mesh patch subjected to heat setting treatment in the step (2) as a receiving base material, and performing electrostatic spinning on the surface of the receiving base material to form a nano composite fiber membrane to prepare the nano composite anti-adhesion hernia repair patch, wherein the electrostatic spinning process parameters are as follows: the voltage was 15kV and the reception distance was 16 cm.
The prepared nano composite anti-adhesion hernia repair patch has a 2-layer structure and comprises a polypropylene warp-knitted mesh patch layer and a nanofiber membrane layer which are adjacent, wherein the thickness of the nanofiber membrane is 0.7 mu m, and the diameter of fibers in the nanofiber membrane is 254 nm.
The bending rigidity of the prepared nano composite anti-adhesion hernia repair patch is 3.54.
Examples 113 to 114
A method for preparing a nano composite anti-adhesion hernia repair patch, which has the same steps as example 112, and is different from the steps that in example 113, the warp knitting mesh patch in step (1) is made of polyvinylidene fluoride, and in example 114, the warp knitting mesh patch in step (1) is made of expanded polytetrafluoroethylene.
Claims (9)
1. A preparation method of a nano composite anti-adhesion hernia repair patch is characterized by comprising the following steps: compounding the warp knitting mesh patch with a nanofiber membrane through electrostatic spinning to prepare a nano composite anti-adhesion hernia repair patch, wherein electrostatic spinning solution for electrostatic spinning mainly comprises collagen, PEO, hexafluoroisopropanol and acetic acid;
the warp knitting mesh patch is a satin weave, and the knitting let-off amount: GB1 is 2750 +/-50 mm/rack, GB2 is 2350 +/-50 mm/rack, and the mesh shape is rhombic;
the warp knitting mesh patch is a warp flat and satin compound tissue, and the knitting let-off amount is as follows: GB1 is 2300 + -50 mm/rack, GB2 is 2250 + -50 mm/rack, and the mesh shape is hexagonal;
the warp knitting mesh patch is a variable warp flat tissue, and the knitting warp feeding amount: GB1 is 2880 + -50 mm/rack, GB2 is 2650 + -50 mm/rack, and the mesh shape is circular.
2. The method for preparing the nanocomposite anti-adhesion hernia repair patch according to claim 1, wherein the material of the warp knitted mesh patch is polypropylene, polyvinylidene fluoride or expanded polytetrafluoroethylene.
3. The method for preparing the nanocomposite anti-adhesion hernia repair patch according to claim 2, wherein the warp knitted mesh patch is a polypropylene mesh after heat setting treatment.
4. The preparation method of the nanocomposite anti-adhesion hernia repair patch according to claim 3, wherein the heat setting temperature is 120-140 ℃ and the time is 8-12 min, the longitudinal elongation of the polypropylene mesh during the heat setting is 0-8.6%, and the transverse elongation is 0-6.41%;
the polypropylene mesh is formed by warp knitting polypropylene monofilaments, wherein the polypropylene monofilaments are medical polypropylene monofilaments, the diameter of the medical polypropylene monofilaments is 0.152 +/-0.005 mm, the warp knitting drawing density is 10 +/-2 courses/cm, and the breadth is 0.5-1 m.
5. The method for preparing the nanocomposite anti-adhesion hernia repair patch according to claim 1, wherein the electrospinning solution is prepared by mixing collagen and PEO, dissolving in a mixed solvent of hexafluoroisopropanol and acetic acid, and stirring.
6. The preparation method of the nanocomposite anti-adhesion hernia repair patch according to claim 5, wherein the mass ratio of collagen to PEO is 70-90: 30-10, the volume ratio of hexafluoroisopropanol to acetic acid is 1:1, the total solute concentration of the electrostatic spinning solution is 3-7.5 wt%, the stirring is magnetic stirring, the stirring time is 24 hours, and the stirring speed is 400 r/min.
7. The preparation method of the nanocomposite anti-adhesion hernia repair patch according to claim 1, wherein the electrostatic spinning process parameters are as follows: the voltage is 8-16 kV, and the receiving distance is 16-24 cm.
8. The nano-composite anti-adhesion hernia repair patch prepared by the preparation method of the nano-composite anti-adhesion hernia repair patch as defined in any one of claims 1 to 7, which is characterized in that: has a composite layer structure, comprising adjacent warp knitting mesh patch layers and nanofiber membrane layers.
9. The nanocomposite anti-adhesion hernia repair patch according to claim 8, wherein the warp knitted mesh patch is 0.5524-0.8169 mm thick, the nanofiber membrane is 0.7-1.8 μm thick, and the diameter of the fibers in the nanofiber membrane is 254-597 nm.
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| CN201227334Y (en) * | 2008-04-11 | 2009-04-29 | 北京天助畅运医疗技术有限公司 | Hernia repair slice |
| CN101530353A (en) * | 2008-04-11 | 2009-09-16 | 北京天助畅运医疗技术有限公司 | Anti-adhesion hernia repair patch |
| CN102085122A (en) * | 2011-03-01 | 2011-06-08 | 东华大学 | Polypropylene/polyvinylidene fluoride composite hernia patch and preparation method thereof |
| WO2015186937A1 (en) * | 2014-06-02 | 2015-12-10 | 주식회사 아모그린텍 | Microneedle patch and production method therefor |
| CN105597154A (en) * | 2016-01-21 | 2016-05-25 | 东华大学 | Polypropylene/polylactic acid interwoven composite pelvic floor mesh and preparation method thereof |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201227334Y (en) * | 2008-04-11 | 2009-04-29 | 北京天助畅运医疗技术有限公司 | Hernia repair slice |
| CN101530353A (en) * | 2008-04-11 | 2009-09-16 | 北京天助畅运医疗技术有限公司 | Anti-adhesion hernia repair patch |
| CN102085122A (en) * | 2011-03-01 | 2011-06-08 | 东华大学 | Polypropylene/polyvinylidene fluoride composite hernia patch and preparation method thereof |
| WO2015186937A1 (en) * | 2014-06-02 | 2015-12-10 | 주식회사 아모그린텍 | Microneedle patch and production method therefor |
| CN105597154A (en) * | 2016-01-21 | 2016-05-25 | 东华大学 | Polypropylene/polylactic acid interwoven composite pelvic floor mesh and preparation method thereof |
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