CN102526812A - Biodegradable multi-layered hernia repairing sheet and preparation methods thereof - Google Patents
Biodegradable multi-layered hernia repairing sheet and preparation methods thereof Download PDFInfo
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- CN102526812A CN102526812A CN2012100227853A CN201210022785A CN102526812A CN 102526812 A CN102526812 A CN 102526812A CN 2012100227853 A CN2012100227853 A CN 2012100227853A CN 201210022785 A CN201210022785 A CN 201210022785A CN 102526812 A CN102526812 A CN 102526812A
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Abstract
The invention provides a biodegradable multi-layered hernia repairing sheet, comprising a biodegradable polymer network sheet and a biocompatible natural high-molecular material membrane layer. The invention also provides two preparation methods of the hernia repairing sheet, wherein the first preparation method comprises the following steps of: preparing biodegradable polymer solution and the biocompatible natural high-molecular material membrane layer; laying the membrane layer on the biodegradable polymer solution, and after the biodegradable polymer solution is volatized, obtaining a composite membrane with a biodegradable polymer layer at one surface; and leading the biodegradable polymer network sheet and a biocompatible polymer layer of the composite membrane to be opposite and hot-pressed into a whole, i.e., obtaining the biodegradable multi-layered hernia repairing sheet. The second preparation method comprises the following steps of: preparing the biodegradable polymer solution and biocompatible natural high-molecular material solution; and laying the natural high-molecular material solution on the biodegradable polymer solution, freeze-drying into a whole, i.e., obtaining the biodegradable multi-layered hernia repairing sheet. The hernia repairing sheet can be used for abdominal implantation, enhancing the functions of weak or defective tissues, and reduces the risk of adhesion occurring in the organs.
Description
Technical field
The present invention relates to biodegradable multilamellar hernia patch that is used for the intraperitoneal implantation and preparation method thereof.
Background technology
Hernia is common disease of department of general surgery and frequently-occurring disease, it is generally acknowledged that its pathogeny mainly is internal organs or tissue damaged or weak spot that morbid state arranged and forms to body surface is outstanding.Traditional hernia method for repairing and mending is that the non-rational high-tension of different organizations is sewed up, and patient often produces wound and has an intense pain, and recovery time is long, and the postoperative recurrence rate is high, and this has brought great misery and inconvenience to patient.
The artificial material of using the earliest can be traced back to the inguinal hernia kposthesis that La Roque doctor in 1919 carries out with wire netting.Although the wire netting histocompatibility is better, stronger anti-infection ability is arranged, because its not folding, poor compliance fails commercialization just to be eliminated.Appearance and fast development in mid-term in 20th century along with the novel artificial synthetic material, U.S. physician Usher had used the net sheet of synthetic to carry out herniorrhaphy and achieving success first in 1958.Afterwards, scientist finds that again polypropylene has more advantage than polyethylene.Ethicon companies in 1970 have also produced a kind of net of polypropylene woven, and commodity are called Prolene.Real artificial material is after 1986 in the extensive use of hernia surgery; U.S. hernia surgical specialist Lichtenstein has proposed the notion of no tension force herniorrhaphy, and its method is to be sutured in the inguinal canal rear wall and to substitute traditional tension force stitching with an artificial mesh-type patches.Tension-free Hernioplasty is to the additional of conventional repair and revises that it is damaged that its advantage is to replace local organization with the prosthese patching material, the intensive aspect tissue intensity; Rebulid interior collar extension, meet The normal anatomic and physiological, relapse rate is low; The postoperative complication incidence rate is low, and pain is little, and surgical injury is little; Recover fast, needn't limit physical exertion.
Ideal surgical operation with the biological requirement of patching material is: embedded material causes physical change at organization internal, and no chemism does not cause inflammation and foreign body reaction; Non-carcinogenesis; Do not cause irritated and high sensitization, have excellent biological compatibility, do not upset electrolyte balance etc.The physical property of patch requires to be generally: can tolerate certain mechanical fatigue, can resist human body abdominal pressure and damaged body and press, can carry out cutting on demand, can sterilize.In addition, because the particularity of the hernia region of anatomy, hernia patch also should have stronger tensile strength; Has less waist flexibility limit; Stronger anti-infection ability and docile property should be porous, are beneficial to the drain of transudate and the interior growth of fibroblast.
Hernia patch commonly used at present is polyester patches, polypropylene sticking patch and expanded polytetrafluoroethylsealing sticking patch.The advantage of polypropylene and polyester material is that the mesh of braiding is bigger, is beneficial to surrounding tissue and grows into, and has improved tissue intensity and pull resistance.Because the big macrophage of mesh can pass in and out with leukocyte, eliminate the antibacterial in the net in addition, so this type sticking patch there is anti-infectious function preferably, in case infect, will the sticking patch taking-up; But above-mentioned two kinds of material sticking patch all can not be put into the abdominal cavity and contact with internal organs, because a large amount of zoopery and clinical observation find that these two kinds net sheets block even intestinal fistula if can produce serious adhesion, digestive tract with tissue at intraperitoneal.The expanded polytetrafluoroethylsealing sticking patch is a kind of microporosity material, is difficult for forming adhesion when contacting with abdominal viscera.But fibroblast and macrophage etc. can not get in the micropore, so fastness after repairing and anti-infection ability also not as good as polypropylene and polyester patches, could be controlled in case the generation infection must be removed patching material.
The anti product of Gore company exploitation provides effective separate tissue, but is prone to cause infection, and the mesothelial cell can not grow into.The Parietex sticking patch of Tyco company exploitation is the MULTILAYER COMPOSITE sticking patch with the Sepramesh sticking patch of Bard company exploitation, in the preparation process, has passed through the multistep chemical reaction, can not the ten minutes strong bonded between each layer, and cost is higher.
The said goods exists complicated process of preparation, many, layering and the preventing adhesiving effect existence dispute etc. easily of chemical reaction, and price is very expensive.
Summary of the invention
In order to address the above problem, the invention provides a kind of biodegradable multilamellar hernia patch and preparation method thereof.
Biodegradable multilamellar hernia patch provided by the invention comprises the macromolecule membranous layer that biodegradable polymer net sheet and biocompatible natural macromolecular material are processed, and said biodegradable polymer net sheet and said macromolecule membranous layer can combine through the direct combination of lyophilization or by the biodegradable polymer intermediate layer.
Said biocompatible natural macromolecular material is one or more in hyaluronic acid, chitosan, cellulose, gelatin, alginic acid, the collagen.
The material in said biodegradable polymer net sheet and biodegradable polymer intermediate layer is polycaprolactone (PCL), gather and third hand over caprolactone (PLCL), gather second and hand over caprolactone (PGCL), poly (l-lactic acid) (PLLA), polyglycolic acid (PGA), gather one or more the copolymer in dioxanone (PDS), the beta-hydroxy-butanoic acid ester (PHB).
Biodegradable multilamellar hernia patch method for preparing 1 provided by the invention may further comprise the steps:
(1) the biodegradable polymer material is become solution with dissolution with solvents;
(2) obtain the macromolecule membranous layer processed by biocompatible natural macromolecular material;
(3) said macromolecule membranous layer is layered on the said solution, obtains the composite membrane that single face has the biodegradable polymer layer after the volatilization;
(4) the biodegradable polymer layer of biodegradable polymer net sheet and said composite membrane is relative, and hot pressing becomes one, and is biodegradable multilamellar hernia patch.
Biodegradable multilamellar hernia patch method for preparing 2 provided by the invention may further comprise the steps:
(1) the biodegradable polymer material is become solution with dissolution with solvents;
(2) obtain the solution processed by biocompatible natural macromolecular material;
(3) solution with said natural macromolecular material is layered on the solution of biodegradable polymer, and lyophilization becomes one, and is biodegradable multilamellar hernia patch.
Solvent described in the step (1) is chloroform or dichloromethane or acetone or oxolane or N-Methyl pyrrolidone or N in step in the method for preparing 1 (1) and the method for preparing 2, dinethylformamide or hexafluoroisopropanol or 1,4-dioxane.
Said biocompatible natural macromolecular material is one or more in hyaluronic acid, chitosan, cellulose, gelatin, alginic acid, the collagen.
The material in said biodegradable polymer net sheet and biodegradable polymer intermediate layer is polycaprolactone (PCL), gather and third hand over caprolactone (PLCL), gather second and hand over caprolactone (PGCL), poly (l-lactic acid) (PLLA), polyglycolic acid (PGA), gather one or more the copolymer in dioxanone (PDS), the beta-hydroxy-butanoic acid ester (PHB).
Hot pressing temperature is 100-115 ℃ described in the step in the method for preparing 1 (4), and the time is 5-15 second.
Cryodesiccated temperature is-80 ℃ described in the step in the method for preparing 2 (3), and the time is 10 hours.
Biodegradable multilamellar hernia patch provided by the invention is easy to produce, and each layer combines firmly, and physics, chemistry, biology performance are stablized, and good preventing adhesiving effect is arranged.The preparation technology of biodegradable multilamellar hernia patch provided by the invention is simple, and the product that makes has above-mentioned premium properties.Specifically, the present invention adopts the raw material of reasonably optimizing, through two kinds of simple relatively but tight reasonable technology processes, prepared combine between the multilayer material firmly, biodegradable multilamellar hernia patch that preventing adhesiving effect is good.Principle of the present invention is that biodegradable multilamellar hernia patch constitutes by Biodegradable material.The ground floor material is a biodegradable polymeric web sheet; And macromolecule membranous layer or natural polymer rete that second layer material is a natural macromolecular material to be processed add the biodegradable polymer identical or different with ground floor, the biodegradable multilamellar hernia patch that obtains combining closely through lyophilization or hot pressing.Advantage of the present invention is that there is not chemical reaction in (1), without chemical reagent such as oxidant, cross-linking agent; (2) technology is simple, is fit to large-scale industrial production, is significantly reduced to this; (3) highly versatile, this technology is fit to the variation of every layer material, is fit to be prepared into the biodegradable multilamellar hernia patch of different degradation cycles and pliability; (4) material therefor is biodegradable, and the discharge of can degrading does not gradually in vivo cause inflammation, and does not have irritated reaction, and not carcinogenic, content of beary metal is low, does not cause haemolysis and blood coagulation, and histocompatibility is good etc.(5) in material, can add various antimicrobial components, like nanometer silver microgranule, triclosan microgranule etc., these antimicrobial components progressively obtain along with the degraded of material discharging, and have wide spectrum, strong effect, persistent anti-infection ability.
The specific embodiment
Embodiment 1
With concentration is that 2% collagen solution is poured in the mould that the degree of depth is 1mm, and through lyophilization, obtaining thickness is the collagen rete of 1mm;
Configuration concentration is 5% PLLA 1, and the 4-dioxane solution is got in the mould of plating poly tetrafluoroethylene that 25mL is cast in 250cm2, and the collagen rete is layered on the solution, and the room temperature volatile dry obtains PLLA/ collagen duplicature;
The PLLA face of PLLA being netted sheet and PLLA/ collagen duplicature is relative, on hot press, presses 10s for 105 ℃, obtains composite patch.Combine well between this each layer of sticking patch, cut out not stratifiedly, it is not stratified in aqueous solution, to soak 24h, very soft.
Embodiment 2
With concentration is that 2% gelatin solution is poured in the mould that the degree of depth is 2mm, and through lyophilization, obtaining thickness is the gelatin rete of 2mm;
Configuration concentration is 5% PCL hexafluoroisopropanol solution, gets in the mould of plating poly tetrafluoroethylene that 25mL is cast in 250cm2, and the gelatin rete is layered on the solution, and the room temperature volatile dry obtains PCL/ collagen duplicature;
The PCL face of PCL being netted sheet and PCL/ collagen duplicature is relative, on hot press, presses 10s for 105 ℃, obtains composite patch.Combine well between this each layer of sticking patch, cut out not stratifiedly, it is not stratified in aqueous solution, to soak 24h, very soft.
Embodiment 3
With concentration is that 1% hyaluronic acid solution is poured in the mould that the degree of depth is 2mm, and through lyophilization, obtaining thickness is the hyaluronic acid rete of 2mm;
Configuration concentration is 10% PLCL chloroformic solution, gets in the mould of plating poly tetrafluoroethylene that 25mL is cast in 250cm2, and the hyaluronic acid rete is layered on the solution, and the room temperature volatile dry obtains PLCL/ hyaluronic acid duplicature;
The PLCL face of PLCL being netted sheet and PLCL/ hyaluronic acid duplicature is relative, on hot press, presses 10s for 105 ℃, obtains composite patch.Combine well between this each layer of sticking patch, cut out not stratifiedly, it is not stratified in aqueous solution, to soak 24h, very soft.
Embodiment 4
With concentration is that 1% chitosan solution is poured in the mould that the degree of depth is 2mm, and through lyophilization, obtaining thickness is the chitosan rete of 2mm;
Configuration concentration is the N of 5% PHB, and dinethylformamide solution is got in the mould of plating poly tetrafluoroethylene that 25mL is cast in 250cm2, and the chitosan rete is layered on the solution, and the room temperature volatile dry obtains PHB/ chitosan duplicature;
The PHB face of PHB being netted sheet and PHB/ chitosan duplicature is relative, on hot press, presses 10s for 105 ℃, obtains composite patch.Combine well between this each layer of sticking patch, cut out not stratifiedly, it is not stratified in aqueous solution, to soak 24h, very soft.
Embodiment 5
Configuration concentration is 5% PLLA 1, the 4-dioxane solution;
Configuration concentration is 2% gelatin solution;
Get 25mLPLLA 1, the 4-dioxane solution is cast in the mould of plating poly tetrafluoroethylene of 250cm2, and gelatin solution is tiled in PLLA solution upper strata.In freezer dryer-80 ℃, 10h obtains composite patch.Combine well between this each layer of sticking patch, cut out not stratifiedly, it is not stratified in aqueous solution, to soak 24h, very soft.
Embodiment 6
Configuration concentration is 5% PLGA tetrahydrofuran solution;
Configuration concentration is 1% chitosan solution;
Get the 25mLPLGA tetrahydrofuran solution, be cast in the mould of plating poly tetrafluoroethylene of 250cm2, chitosan solution is tiled in PLGA solution upper strata.In freezer dryer-80 ℃, 10h obtains composite patch.Combine well between this each layer of sticking patch, cut out not stratifiedly, it is not stratified in aqueous solution, to soak 24h, very soft.
Embodiment 7
Configuration concentration is 10% PLCL acetone soln;
Configuration concentration is 1% chitosan solution;
Get the 25mLPLCL acetone soln, be cast in the mould of plating poly tetrafluoroethylene of 250cm2, chitosan solution is tiled in PLCL solution upper strata.In freezer dryer-80 ℃, 10h obtains composite patch.Combine well between this each layer of sticking patch, cut out not stratifiedly, it is not stratified in aqueous solution, to soak 24h, very soft.
The composite patch of embodiment 1-7 is repaired zoopery through the rabbit intra-abdominal hernia and is shown that the anti performance is fine.Composite patch with embodiment 1 and 5 is an example, in conjunction with contrast, zoopery is described.
The composite patch of preparation in embodiment 1 and 5 is carried out the rabbit intra-abdominal hernia repair zoopery, to assess its anti performance.20 of new zealand white rabbits, weight is between the 2-3.5Kg during every operation.With its anesthesia; At left abdomen excision 20mm * 20mm full depth Musclar layer; Repair with composite patch (5) among the simple polypropylene sticking patch of 30mm * 30mm (listing product, 5 of positive controls), Parietex sticking patch (listing product, 5 of negative controls), the embodiment 1 and the composite patch (5) among the embodiment 5; Sticking patch is fixed on the stomach wall sew up wound with suture.Postoperative was assessed its preventing adhesiving effect in 3 months, comprised adhesion area, adhesion degree, adhesion incidence rate.The result shows that serious adhesion takes place positive control polypropylene sticking patch group, and the adhesion incidence rate is 100%; Slight adhesion takes place in negative control Parietex sticking patch group, and the adhesion incidence rate is about 10%; And the composite patch in embodiment 1 and 5 has effectively prevented the adhesion of abdominal visceral browser and sticking patch.
The present invention still has multiple concrete embodiment, and all employings are equal to replacement or equivalent transformation and all technical schemes of forming, all drop in the scope of requirement protection of the present invention.
Claims (6)
1. biodegradable multilamellar hernia patch; It is characterized in that; This biodegradable multilamellar hernia patch comprises the macromolecule membranous layer that biodegradable polymer net sheet and biocompatible natural macromolecular material are processed, and said biodegradable polymer net sheet and said macromolecule membranous layer can combine through the direct combination of lyophilization or by the biodegradable polymer intermediate layer.
2. biodegradable multilamellar hernia patch according to claim 1 is characterized in that, said biocompatible natural macromolecular material is one or more in hyaluronic acid, chitosan, cellulose, gelatin, alginic acid, the collagen; The material in said biodegradable polymer net sheet and biodegradable polymer intermediate layer is polycaprolactone (PCL), gather and third hand over caprolactone (PLCL), gather second and hand over caprolactone (PGCL), poly (l-lactic acid) (PLLA), polyglycolic acid (PGA), gather one or more the copolymer in dioxanone (PDS), the beta-hydroxy-butanoic acid ester (PHB).
3. a biodegradable multilamellar hernia patch method for preparing 1 is characterized in that, may further comprise the steps:
(1) the biodegradable polymer material is become solution with dissolution with solvents;
(2) obtain the macromolecule membranous layer processed by biocompatible natural macromolecular material;
(3) said macromolecule membranous layer is layered on the said solution, obtains the composite membrane that single face has the biodegradable polymer layer after the volatilization;
(4) the biodegradable polymer layer of biodegradable polymer net sheet and said composite membrane is relative, and hot pressing becomes one, and is biodegradable multilamellar hernia patch.
4. a biodegradable multilamellar hernia patch method for preparing 2 is characterized in that, may further comprise the steps:
(1) the biodegradable polymer material is become solution with dissolution with solvents;
(2) obtain the solution processed by biocompatible natural macromolecular material;
(3) solution with said natural macromolecular material is layered on the solution of biodegradable polymer, and lyophilization becomes one, and is biodegradable multilamellar hernia patch.
5. according to the method for preparing of claim 3,4 described biodegradable multilamellar hernia patch; It is characterized in that; Solvent described in claim 3 step (1) and claim 4 step (1) is chloroform or dichloromethane or acetone or oxolane or N-Methyl pyrrolidone or N; Dinethylformamide or hexafluoroisopropanol or 1, the 4-dioxane.
6. according to the method for preparing of claim 3,4 described biodegradable multilamellar hernia patch, it is characterized in that said biocompatible natural macromolecular material is one or more in hyaluronic acid, chitosan, cellulose, gelatin, alginic acid, the collagen; The material in said biodegradable polymer net sheet and biodegradable polymer intermediate layer is polycaprolactone (PCL), gather and third hand over caprolactone (PLCL), gather second and hand over caprolactone (PGCL), poly (l-lactic acid) (PLLA), polyglycolic acid (PGA), gather one or more the copolymer in dioxanone (PDS), the beta-hydroxy-butanoic acid ester (PHB).
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| CN102772271A (en) * | 2012-07-11 | 2012-11-14 | 北京天助畅运医疗技术股份有限公司 | Self-fixing tissue patch |
| CN105727368A (en) * | 2016-01-08 | 2016-07-06 | 深圳市第二人民医院 | Three-dimensional composite material support and preparation method thereof |
| CN105920670A (en) * | 2016-05-19 | 2016-09-07 | 李世荣 | Degradable male genital organ patch composite material with biological elasticity and preparation method thereof |
| CN106256384A (en) * | 2016-08-30 | 2016-12-28 | 常州市康蒂娜医疗科技有限公司 | A kind of biological sticking patch and preparation method |
| CN106923930A (en) * | 2017-03-13 | 2017-07-07 | 上海瀚达医疗器械有限公司 | Patch based on novel weaving technology and shape and weaving method thereof |
| CN107837129A (en) * | 2017-12-16 | 2018-03-27 | 诺迈尔（苏州）医学科技有限公司 | Non-degradable class hernia paster biocompatibility improved method |
| CN108452380A (en) * | 2018-03-30 | 2018-08-28 | 北京湃生生物科技有限公司 | A kind of bionical tubular material of carrying medicament |
| CN108653824A (en) * | 2018-06-08 | 2018-10-16 | 段降龙 | A kind of new bio sticking patch and preparation method thereof |
| CN109701088A (en) * | 2018-12-19 | 2019-05-03 | 广州润虹医药科技股份有限公司 | A kind of hernia patch of antibacterial anti-inflammatory and preparation method thereof |
| CN111150888A (en) * | 2018-11-07 | 2020-05-15 | 财团法人工业技术研究院 | Double-effect film and preparation method thereof |
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| CN105727368A (en) * | 2016-01-08 | 2016-07-06 | 深圳市第二人民医院 | Three-dimensional composite material support and preparation method thereof |
| CN105920670A (en) * | 2016-05-19 | 2016-09-07 | 李世荣 | Degradable male genital organ patch composite material with biological elasticity and preparation method thereof |
| CN106256384B (en) * | 2016-08-30 | 2019-11-15 | 常州市康蒂娜医疗科技有限公司 | A kind of biological sticking patch and preparation method |
| CN106256384A (en) * | 2016-08-30 | 2016-12-28 | 常州市康蒂娜医疗科技有限公司 | A kind of biological sticking patch and preparation method |
| CN106923930A (en) * | 2017-03-13 | 2017-07-07 | 上海瀚达医疗器械有限公司 | Patch based on novel weaving technology and shape and weaving method thereof |
| CN107837129A (en) * | 2017-12-16 | 2018-03-27 | 诺迈尔（苏州）医学科技有限公司 | Non-degradable class hernia paster biocompatibility improved method |
| CN108452380A (en) * | 2018-03-30 | 2018-08-28 | 北京湃生生物科技有限公司 | A kind of bionical tubular material of carrying medicament |
| CN108653824A (en) * | 2018-06-08 | 2018-10-16 | 段降龙 | A kind of new bio sticking patch and preparation method thereof |
| CN111150888A (en) * | 2018-11-07 | 2020-05-15 | 财团法人工业技术研究院 | Double-effect film and preparation method thereof |
| US11458715B2 (en) | 2018-11-07 | 2022-10-04 | Industrial Technology Research Institute | Bifunctional film and method for preparing the same |
| US11904581B2 (en) | 2018-11-07 | 2024-02-20 | Industrial Technology Research Institute | Bifunctional film |
| CN109701088A (en) * | 2018-12-19 | 2019-05-03 | 广州润虹医药科技股份有限公司 | A kind of hernia patch of antibacterial anti-inflammatory and preparation method thereof |
| CN109701088B (en) * | 2018-12-19 | 2021-12-21 | 广州润虹医药科技股份有限公司 | Antibacterial and anti-inflammatory hernia repair patch and preparation method thereof |
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