CN105311679A - Complex hernia patch and preparing method and application thereof - Google Patents
Complex hernia patch and preparing method and application thereof Download PDFInfo
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- CN105311679A CN105311679A CN201510827025.3A CN201510827025A CN105311679A CN 105311679 A CN105311679 A CN 105311679A CN 201510827025 A CN201510827025 A CN 201510827025A CN 105311679 A CN105311679 A CN 105311679A
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Abstract
The invention provides a complex hernia patch and a preparing method and application thereof. The complex hernia patch comprises three layer structures which are an outer biological layer, an inner supporting layer and an outer biological layer from bottom to top respectively, wherein the outer biological layers are accellular stent layers, and the inner supporting layer is a polylactone mesh layer. The complex hernia patch prepared through the preparing method comprises the three layer structures, accellular stents in contact with tissue are located on the outer layers, cells can be induced to grow, and thus infection of a hernia coloboma part and formation of scars can be reduced; the polylactone mesh layer serves as the inner supporting layer so that the mechanical strength of the complex hernia patch can be maintained, the stability of the patch can be improved, and high abdomen expansion pressure can be borne; furthermore, the binding force of the inner layer and the outer layers is good, and thus the problems that due to the fact that the strength of an existing product is not stable, high abdomen expansion pressure cannot be borne, a stent is gradually degraded after cells grow into the stent, consequently tardive pain of hernia repair is brought, and relapse is likely to occur can be effectively solved; in addition, the preparing method is simple and capable of being applied to industrial production.
Description
Technical field
The invention belongs to medicament preparation field, relate to a kind of compound hernia sticking patch and its preparation method and application.
Background technology
Hernia patch is mainly used in the repairing of abdominal hernia, and abdominal hernia refers to that Intraabdominal organ or tissue is from stomach wall weak area or the bulging of defect place.Abdominal hernia comprises inguinal hernia, umbilical hernia, femoral hernia, incisional hernia and pour hernie parastomiale etc., the most common with inguinal hernia (thigh and abdominal part intersection).Because abdominal hernia has higher sickness rate, therefore its treatment has now become an important social problem.
At present, herniorrhaphy is the only selection of curing abdominal hernia.Herniorrhaphy refers to by operation treating of hernia, can be divided into traditional hernioplasty and hernia sticking patch strain less repair.Current strain less repair has become clinician and has treated the ordinary operation that abdominal hernia takes, and hernia patch is the embedded material of tension-free hernioplasty and laparoscopic surgery.
The U.S.'s celology annual meeting can be divided into two large classes hernia patch material: a class is bioartificial materials's sticking patch, core based on polymer (polymer), and the polymer of employing is polypropylene, polyester and politef; Another kind of is biological sticking patch, it is based on biological nature material, obtains united states drug and food Surveillance Authority (FDA) approval has been used in clinical material and has human body corium, the small intestinal submucosa of pig, the corium of pig, the corium etc. of embryo cattle.
Artificial bio-membrane's sticking patch comprises (1) nonabsorable material: propene polymer patch, expanded polytetrafluoroethylsealing sticking patch, polyester sticking patch.Wherein, the polyester patches of nineteen thirty-nine invention is (also known as dacron patch, PolyesterMesh.Dacron, Mersilene) be first by comparatively widely used synthetic material sticking patch, though nearly 50 years history, but because it is cheap, easily obtain plurality of advantages, so far still by some surgeon are used.But because dacron thread is fibre structure, resisting the polypropylene net not as good as monofilament in infection, inflammation and the foreign body reaction of polyester material are also the heaviest, withdraw from the market gradually.Expanded polytetrafluoroethylsealing sticking patch (ExpandedPolytetrafluoroethylenepatch, e-PTFE) is more soft than first two sticking patch, not easily forms adhesion when contacting with abdominal viscera, and caused inflammatory reaction is also the lightest.E-PTFE sticking patch allow antibacterial pass through, and phagocyte not by, tissue can not grow into, therefore its can not resistance to infected and pollute, the wound polluted can not be used for, once infect, sticking patch will be taken out, otherwise wound be difficult to healing.E-PTFE sticking patch is used for Treatment of Recurrent Inguinal Hernia at present, causes adhesion hardly, so be also used for incisional hernia because itself and internal organs directly contact; For the young inguinal hernia patient that hernia ring defect is little, some complication such as postoperative spermatic cord adhesion, painful ejaculation discomfort can be avoided.Propene polymer patch (PolypropyleneMesh.Marlex, PP) is woven by polypropylene fibre and forms, and is monolayer network structure, is the patching material of abdominal-wall defect first-selected at present.Between 1958 to 1963, Usher writes articles for many times and describes a kind of new material being called Marlex50, compared with the metal of other any types of this material and the same period or nonmetallic materials, all confirm that it has following obvious advantage through zoopery and clinical research: (1) is more soft, more resistance to by bending with folding; (2) can size cut out with the need; (3) stimulate proliferation of fibrous tissue effect more obvious, mesh aperture is large, is more conducive to fibrous tissue growth and passes, easily infiltrated by connective tissue, can be chimeric with tissue in early days; (4) foreign body reaction is slight, and patient, without obvious foreign body and sense of discomfort, has very low relapse rate and complication rate.(5) more resistance to infected, even if granulation tissue still can be bred in the mesh of sticking patch in pyogenic infection wound, do not cause mesh sheet to corrode or tunnel; (6) higher tensile strength is had; (7) impact of water and most of chemical substances is not subject to; (8) high temperature resistant, can scalding; (9) relative low price.Propene polymer patch except for except inguinal hernia operation, be also used to the stomach wall war wound infected, huge abdominal hernia, to cause abdominal-wall defect, the other hernia of artifistulation's mouth, the excision of transitivity abdominal wall tumor capable holostrome stomach wall because of electric burn or infection after reconstruction, the disruption of wound of necrotizing fascitis of abdominal wall posterior abdominal wall and laparoscopically hernia repair.In in the past 50 years, polypropylene mesh creates tremendous influence to surgical field, because there being it, life is continued countless patient, and many surgery knotty problems solve because of its application, and it has been proved to be implant most popular in current surgical field.However, polypropylene net also also exists some problems in the application, and first, when repairing for stomach wall full-thickness defects, sticking patch will be isolated with viscera tissue, requires that doctor has certain understanding and operation basis; Secondly, if carry out large-area abdominal-wall defect repairing, as dealt with improperly, the cicatrix contraction in later stage can cause mesh sheet distortion, and its irregular surface may stimulate and damaging surrounding tissue, causes infection to die skin tunnel.
In order to solve the problem, propose the sticking patch that polypropylene combines with absorbable material, the design of this kind of material take polypropylene net as skeleton, then carry out compound with absorbable material, its objective is the consumption, anti and the infection that reduce foreign body (polypropylene).In absorbable material, polyglycolic acid (polyglycolicacidDexon), polylactic-co-glycolic acid (polyglaetionVieryI) two kinds of Absorbable rod mesh sheet are at Clinical practice, the former is establishment net, the latter is woven cloth, and its complete soak time is 3 months.But grow into because it does not possess inducing cell, the position tension stress after thus repairing is not strong, and hernia defect very easily recurs, and is only suitable for the herniorrhaphy that defect is less.
That commonly uses in the composite has polypropylene and politef compound, polypropylene composite materials, vegetable matter and macromolecular material compound, collagen and macromolecular material compound, it is intended to the foreign body sensation after reducing the implantation of PP material, make wound healing process reduce inflammatory reaction as far as possible, avoid scar tissue to cause chronic pain.Along with the degraded of absorbable material, PP base material still can be exposed between serosal tissue, tardy pain slow down DeGrain.
Another large class sticking patch belongs to regenerative biological sticking patch, generally extracted from natural biology by the crosslinked fixing of advanced person and multi-faceted a series of technology such as antigen of removing, can be understood to " cytoskeleton ", it is according to after regenerative medicine principle, molecular biology principle and immunology principle implant into body, good support effect can be played, fill up the missing tissues of damaged part, and under the induction of this material, human body self repair function can grow in original position the tissue made new advances gradually, replace biomaterial, complete the process of organ tissue regeneration.Mainly apply to neurosurgery, the reparation of endomeninx in early days, repairing, siamese twins cut rear skin, pleura reparation, skull reparation, gynecological, andrology, pulmonary carcinoma, tumor etc. afterwards in esophageal carcinoma excision, also have Emergency Treatment of Extensive Burn patient, and start now to probe into the use in shaping and beauty field.But because of its source instability, final products intensity is also unstable, and be difficult to bear higher abdomen and open pressure, after cell is grown into, support can be degraded gradually, and thus relapse rate is also much higher compared with synthetic sticking patch.
Therefore, needing exploitation one badly can either grow into by inducing cell in this area, can have good mechanical strength again, after cell is grown into, reduce tardy pain, and reduce the hernia patch with comprehensive premium properties of cicatrization.
Summary of the invention
For the deficiencies in the prior art, the object of the present invention is to provide a kind of compound hernia sticking patch and its preparation method and application.
For reaching this object, the present invention by the following technical solutions:
On the one hand, the invention provides a kind of compound hernia sticking patch, described compound hernia sticking patch comprises three-decker, is respectively outer biosphere, internal layer supporting layer and outer biosphere from bottom to top, described outer biosphere is de-cytoskeleton layer, and described internal layer supporting layer is polylactone mesh sheet layer.
In the present invention, the internal layer of the compound hernia sticking patch of three-decker is polylactone mesh sheet layer, and it is as supporting layer, it is de-cytoskeleton layer in the both sides of polylactone mesh sheet layer, as outer biosphere, this de-cytoskeleton layer easily and contact tissue, (this layer therefore also can be claimed to be outer inducing layer) can be increased by inducing cell, infection and the cicatrization of hernia defect can be reduced, in addition, internal layer supporting layer---polylactone mesh sheet layer can keep the mechanical strength of this compound hernia sticking patch, ensure the stability of product strength, higher abdomen can be born and open pressure, even if after cell is grown into, when support is degraded gradually, also the tardy pain that hernia is instantly repaired can effectively be solved, the problems such as easy recurrence, and polylactone belongs to the degradable material of human body Absorbable rod, have no side effect, safety is high.
In the present invention, described de-cytoskeleton is that cattle bladder takes off cytoskeleton, pig small intestine take off cytoskeleton or Vesica sus domestica takes off the combination of any one or at least two kinds in cytoskeleton.Described combination can take off cytoskeleton for cattle bladder and pig small intestine take off cytoskeletal combination, pig small intestine take off cytoskeleton and Vesica sus domestica takes off cytoskeletal combination, cattle bladder takes off cytoskeleton and Vesica sus domestica takes off cytoskeletal combination, and cattle bladder takes off cytoskeleton, pig small intestine take off cytoskeleton and Vesica sus domestica takes off cytoskeletal combination.
In the present invention, the hole of described outer biosphere is 20 μm-500 μm, such as 20 μm, 25 μm, 30 μm, 40 μm, 50 μm, 60 μm, 80 μm, 100 μm, 130 μm, 150 μm, 180 μm, 200 μm, 250 μm, 280 μm, 300 μm, 330 μm, 360 μm, 400 μm, 450 μm, 480 μm or 500 μm.
Preferably, the thickness of described outer biosphere is 200 μm of-2mm, such as 220 μm, 250 μm, 280 μm, 300 μm, 350 μm, 380 μm, 400 μm, 450 μm, 500 μm, 550 μm, 600 μm, 650 μm, 700 μm, 800 μm, 900 μm, 1mm, 1.2mm, 1.4mm, 1.6mm, 1.8mm or 1.9mm, preferred 200-800 μm.
In the present invention, the monofilament that described polylactone mesh sheet is 0.3-0.6mm by diameter weaves, and pitch-row is 2-5mm, such as 2.1mm, 2.3mm, 2.5mm, 2.8mm, 3mm, 3.2mm, 3.5mm, 3.8mm, 4mm, 4.2mm, 4.5mm, 4.8mm or 4.9mm.
Preferably, described polylactone monofilament is selected from the combination of any one or at least two kinds in polycaprolactone glycolide copolymer monofilament, PGA monofilament, polylactide-co-glycolide monofilament or polydioxanone monofilament.Described combination can be but be not limited to the combination of polycaprolactone glycolide copolymer monofilament and PGA monofilament, the combination of PGA monofilament and polylactide-co-glycolide monofilament, the combination of polylactide-co-glycolide monofilament and polydioxanone monofilament, the combination of polycaprolactone glycolide copolymer monofilament, PGA monofilament and polylactide-co-glycolide monofilament, the combination of PGA monofilament, polylactide-co-glycolide monofilament and polydioxanone monofilament.
On the other hand, the invention provides the preparation method of compound hernia sticking patch as described in relation to the first aspect, said method comprising the steps of:
(1) outer biosphere is laid on substrate, outer biosphere is placed internal layer supporting layer, then on internal layer supporting layer, place another outer biosphere, the two ends of the three-decker tiled and substrate are fixed;
(2) three-decker be fixed on substrate that step (1) obtains is soaked in impregnation liquid, and afterwash impregnation liquid, the outer biosphere in the end placed adds another substrate to cover, dry under hot pressing state, take off and obtain described compound hernia sticking patch from substrate.
In the present invention, before preparation compound hernia sticking patch, also comprise and outer biosphere and internal layer supporting layer are carried out pretreated step respectively.
Preferably, the pretreatment of described outer biosphere is that outer biosphere is soaked 6-12h, such as 6.2h, 6.5h, 6.8h, 7h, 7.4h, 7.8h, 8h, 8.4h, 8.7h, 9h, 9.5h, 9.8h, 10h, 10.3h, 10.8h, 11h, 11.3h, 11.5h or 11.8h in the sodium bicarbonate solution of pH=8-10 (such as pH8.2,8.4,8.6,9,9.3,9.5 or 9.8).
Preferably, the pretreatment of described internal layer supporting layer is that internal layer supporting layer is soaked 10-30min, such as 10min, 12min, 15min, 18min, 20min, 23min, 25min, 28min or 30min in the hydrochloride buffer of pH=3-5 (such as pH3.1,3.2,3.5,3.8,4,4.2,4.4,4.6 or 4.8).
In the present invention, described outer biosphere for the de-cytoskeleton that gone on the market or can obtain corresponding de-cytoskeleton with conventional chemical processes or enzymatic process process cattle bladder, pig small intestine or Vesica sus domestica, described chemical method refers to carries out soaking and stirring washing by peracetic acid (mass body volume concentrations is 0.1-0.15%) to cattle bladder, pig small intestine or Vesica sus domestica, and drying obtains corresponding de-cytoskeleton after pure water cleaning repeatedly afterwards.Described enzymatic process refers to and utilizes trypsin 0.05% trypsin/0.05%EDTA) aqueous solution carries out soaking and stirring washing to cattle bladder, pig small intestine or Vesica sus domestica, and drying obtains corresponding de-cytoskeleton after pure water cleaning repeatedly afterwards.
In the present invention, described internal layer supporting layer can be that the polylactone mesh sheet product gone on the market or the polylactone monofilament utilizing diameter to be 0.3-0.6mm are woven into mesh sheet according to knitting skill well known in the art.
Preferably, in the present invention, step (1) and step (2) described substrate are any one in glass plate, corrosion resistant plate or physics and chemistry plate.In the present invention particular restriction be there is no for described substrate, except the above-mentioned several substrates listed, other levelness can also be used dull and stereotyped preferably.
Preferably, the weight of step (1) and step (2) described substrate is 500g-2kg, such as 510g, 550g, 600g, 700g, 800g, 1kg, 1.2kg, 1.4kg, 1.6kg, 1.8kg or 1.9kg.
In preparation method of the present invention, step (2) is described soaks for being soak 10-40min in the impregnation liquid of 50%, 60%, 75%, 90% and 95% respectively at Concentraton gradient in impregnation liquid, such as 10min, 15min, 20min, 25min, 30min, 35min or 40min.
Preferably, step (2) described impregnation liquid is the mixed aqueous solution of ethanol and glycerol, wherein ethanol and glycerol volume ratio are 1:1-5:1, such as 1.2:1,1.5:1,1.8:1,2:1,2.3:1,2.5:1,2.8:1,3:1,3.5:1,3.8:1,4:1,4.3:1,4.5:1,4.8:1 or 4.9:1, preferred 4:1.
In the present invention, when the mixed aqueous solution of ethanol and glycerol selected by impregnation liquid, the gradient concentration (50%, 60%, 75%, 90% and 95%) of the impregnation liquid used refers to ethanol and glycerol total volume concentration in the mixed aqueous solution of ethanol and glycerol.
Preferably, the temperature of step (2) described hot pressing is 40-60 DEG C, such as 42 DEG C, 44 DEG C, 46 DEG C, 48 DEG C, 50 DEG C, 53 DEG C, 55 DEG C, 57 DEG C or 59 DEG C.
Preferably, step (2) described drying is carried out in vacuum drying oven.
Preferably, the temperature of step (2) described drying is 40-60 DEG C, such as 42 DEG C, 44 DEG C, 46 DEG C, 48 DEG C, 50 DEG C, 53 DEG C, 55 DEG C, 57 DEG C or 59 DEG C.
In the present invention, described under hot pressing state dry referring to the three-decker be placed between two-layer substrate (each substrate weight is 500g-2kg) is processed in vacuum drying oven at temperature 40-60 DEG C, when substrate press against the material of three-decker, evacuation, some solvents volatilization that material contains, now, three-decker has partial fusion, strengthen its adhesion, strengthen the mechanical strength of the compound hernia sticking patch obtained, in this process, if do not have substrate to press against the material of three-decker, then material shrinks, be difficult to obtain smooth material, also be difficult to ensure the adhesion between three-decker, thus its mechanical strength cannot be ensured.Hot pressing is in the present invention carried out with dry simultaneously, and the temperature of therefore hot pressing is identical with dry temperature, and the temperature all by controlling vacuum drying oven realizes.
As the preferred technical solution of the present invention, the preparation method of compound hernia sticking patch of the present invention specifically comprises the following steps:
(1) outer biosphere is soaked in the sodium bicarbonate solution of pH=8-10 6-12h and carry out pretreatment, internal layer supporting layer is soaked in the hydrochloride buffer of pH=3-5 10-30min and carry out pretreatment;
(2) pretreated outer biosphere is laid on substrate, outer biosphere is placed pretreated internal layer supporting layer, on internal layer supporting layer, then place another pretreated outer biosphere, the two ends of the three-decker tiled and substrate are fixed;
(3) three-decker on substrate that is fixed on step (1) obtained is soak 10-40min respectively in the impregnation liquid of 50%, 60%, 75%, 90% and 95% in the gradient of volumetric concentration, wherein impregnation liquid is the mixed aqueous solution of ethanol and glycerol, wherein ethanol and glycerol volume ratio are 1:1-5:1, and afterwash impregnation liquid, the outer biosphere in the end placed adds another substrate to cover, dry under hot pressing state in the vacuum drying oven of 40-60 DEG C, the temperature of described drying is 40-60 DEG C, then takes off and obtain described compound hernia sticking patch from substrate.
The compound hernia sticking patch utilizing the inventive method to prepare, ectonexine adhesion is good, supporting layer is positioned at internal layer, by in this compound hernia sticking patch implantation process, supporting layer not with contact tissue, suture strength is moderate, with contact tissue be can the de-cytoskeleton that increases of inducing cell, infection and the cicatrization of hernia defect can be reduced; The polylactone of supporting layer still can keep its mechanical strength, effectively can solve the problem such as tardy pain, easy recurrence that hernia is instantly repaired.
On the other hand, the invention provides the application of compound hernia sticking patch in the material for the preparation of the infection or reduction cicatrization for the treatment of hernia defect as described in relation to the first aspect.The compound hernia sticking patch that the present invention prepares can be used for the treatment of hernia through vacuum sterilization rear.
Now for prior art, the present invention has following beneficial effect:
The present invention adopts the compound hernia sticking patch comprising three-decker, owing to being positioned at skin with the de-cytoskeleton of contact tissue, can increase by inducing cell, thus infection and the cicatrization of hernia defect can be reduced, utilize polylactone mesh sheet layer can keep the mechanical strength of compound hernia sticking patch as internal layer supporting layer, improve the stability of sticking patch, higher abdomen can be born and open pressure, and ectonexine adhesion is good, can effectively solve current due to product strength instability, be difficult to bear higher abdomen and open pressure, after cell is grown into, the problems such as the Delayed soreness that the hernia that support is degraded gradually and brought is repaired and easily recurrence, and compound hernia sticking patch preparation method of the present invention is simple, can be applicable to commercial production.
Detailed description of the invention
Technical scheme of the present invention is further illustrated below by detailed description of the invention.Those skilled in the art should understand, described embodiment is only help to understand the present invention, should not be considered as concrete restriction of the present invention.
Embodiment 1
In the present embodiment, prepare compound hernia sticking patch by the following method, specifically comprise the following steps:
(1) cattle bladder is taken off cytoskeleton layer (Cook biotech company) in the sodium bicarbonate solution of pH=8, to soak 12h carry out pretreatment, polylactone mesh sheet layer is soaked 20min in the hydrochloride buffer of pH=5 and carries out pretreatment;
(2) pretreated cattle bladder is taken off the tiling of cytoskeleton layer on a glass, take off on cytoskeleton layer at cattle bladder and place pretreated polylactone mesh sheet layer (Johnson & Johnson), on polylactone mesh sheet layer, then place another pretreated cattle bladder take off cytoskeleton layer, the two ends of the three-decker tiled and glass plate rubber band are fixed;
(3) three-decker on glass plate that is fixed on step (1) obtained is soak 30min respectively in the impregnation liquid of 50%, 60%, 75%, 90% and 95% in the gradient of volumetric concentration, wherein impregnation liquid is the mixed aqueous solution of ethanol and glycerol, wherein ethanol and glycerol volume ratio are 4:1, and afterwash impregnation liquid, take off rubber band, the cattle bladder in the end placed takes off on cytoskeleton layer and adds the covering of another glass plate, dry under hot pressing state in the vacuum drying oven of 50 DEG C, then take off from glass plate and obtain described compound hernia sticking patch.
Embodiment 2
In the present embodiment, prepare compound hernia sticking patch by the following method, specifically comprise the following steps:
(1) pig small intestine are taken off cytoskeleton layer (Cook biotech company) in the sodium bicarbonate solution of pH=10, to soak 6h carry out pretreatment, polylactone mesh sheet layer is soaked 10min in the hydrochloride buffer of pH=4 and carries out pretreatment;
(2) pretreated cattle bladder is taken off the tiling of cytoskeleton layer on a glass, take off on cytoskeleton layer at pig small intestine and place pretreated polylactone mesh sheet layer, on polylactone mesh sheet layer, then place another pretreated pig small intestine take off cytoskeleton layer, the two ends of the three-decker tiled and glass plate rubber band are fixed;
(3) three-decker on glass plate that is fixed on step (1) obtained is soak 10min respectively in the impregnation liquid of 50%, 60%, 75%, 90% and 95% in the gradient of volumetric concentration, wherein impregnation liquid is the mixed aqueous solution of ethanol and glycerol, wherein ethanol and glycerol volume ratio are 1:1, and afterwash impregnation liquid, take off rubber band, the pig small intestine in the end placed take off on cytoskeleton layer and add the covering of another glass plate, dry under hot pressing state in the vacuum drying oven of 40 DEG C, then take off from glass plate and obtain described compound hernia sticking patch.
Embodiment 3
In the present embodiment, prepare compound hernia sticking patch by the following method, specifically comprise the following steps:
(1) Vesica sus domestica is taken off cytoskeleton layer (Cook biotech company) in the sodium bicarbonate solution of pH=9, to soak 10h carry out pretreatment, polylactone mesh sheet layer is soaked 10min in the hydrochloride buffer of pH=3 and carries out pretreatment;
(2) pretreated Vesica sus domestica is taken off the tiling of cytoskeleton layer on a glass, take off on cytoskeleton layer at Vesica sus domestica and place pretreated polylactone mesh sheet layer, on polylactone mesh sheet layer, then place another pretreated Vesica sus domestica take off cytoskeleton layer, the two ends of the three-decker tiled and glass plate rubber band are fixed;
(3) three-decker on glass plate that is fixed on step (1) obtained is soak 20min respectively in the impregnation liquid of 50%, 60%, 75%, 90% and 95% in the gradient of volumetric concentration, wherein impregnation liquid is the mixed aqueous solution of ethanol and glycerol, wherein ethanol and glycerol volume ratio are 5:1, and afterwash impregnation liquid, take off rubber band, the Vesica sus domestica in the end placed takes off on cytoskeleton layer and adds the covering of another glass plate, dry under hot pressing state in the vacuum drying oven of 60 DEG C, then take off from glass plate and obtain described compound hernia sticking patch.
Embodiment 4
In the present embodiment, prepare compound hernia sticking patch by the following method, specifically comprise the following steps:
(1) cattle bladder is taken off cytoskeleton layer in the sodium bicarbonate solution of pH=8, to soak 8h carry out pretreatment, polylactone mesh sheet layer is soaked 30min in the hydrochloride buffer of pH=5 and carries out pretreatment;
(2) pretreated cattle bladder is taken off the tiling of cytoskeleton layer on a glass, take off on cytoskeleton layer at cattle bladder and place pretreated polylactone mesh sheet layer, on polylactone mesh sheet layer, then place another pretreated cattle bladder take off cytoskeleton layer, the two ends of the three-decker tiled and glass plate rubber band are fixed;
(3) three-decker on glass plate that is fixed on step (1) obtained is soak 40min respectively in the impregnation liquid of 50%, 60%, 75%, 90% and 95% in the gradient of volumetric concentration, wherein impregnation liquid is the mixed aqueous solution of ethanol and glycerol, wherein ethanol and glycerol volume ratio are 4:1, and afterwash impregnation liquid, take off rubber band, the cattle bladder in the end placed takes off on cytoskeleton layer and adds the covering of another glass plate, dry under hot pressing state in the vacuum drying oven of 50 DEG C, then take off from glass plate and obtain described compound hernia sticking patch.
Embodiment 5
In the present embodiment, prepare compound hernia sticking patch by the following method, specifically comprise the following steps:
(1) cattle bladder is taken off cytoskeleton layer in the sodium bicarbonate solution of pH=10, to soak 6h carry out pretreatment, polylactone mesh sheet layer is soaked 20min in the hydrochloride buffer of pH=5 and carries out pretreatment;
(2) pretreated cattle bladder is taken off the tiling of cytoskeleton layer on a glass, take off on cytoskeleton layer at cattle bladder and place pretreated polylactone mesh sheet layer, on polylactone mesh sheet layer, then place another pretreated cattle bladder take off cytoskeleton layer, the two ends of the three-decker tiled and glass plate rubber band are fixed;
(3) three-decker on glass plate that is fixed on step (1) obtained is soak 30min respectively in the impregnation liquid of 50%, 60%, 75%, 90% and 95% in the gradient of volumetric concentration, wherein impregnation liquid is the mixed aqueous solution of ethanol and glycerol, wherein ethanol and glycerol volume ratio are 4:1, and afterwash impregnation liquid, take off rubber band, the cattle bladder in the end placed takes off on cytoskeleton layer and adds the covering of another glass plate, dry under hot pressing state in the vacuum drying oven of 60 DEG C, then take off from glass plate and obtain described compound hernia sticking patch.
Embodiment 6
In the present embodiment, investigate compound hernia sticking patch to the impact of the infection of hernia defect, experimental technique is as follows:
The compound hernia sticking patch prepared by embodiment of the present invention 1-5 is implanted to be needed to carry out in the rabbit body of hernia reparation, in matched group, independent polylactone mesh sheet is implanted and needs to carry out in the rabbit body of hernia reparation, after 1 month, observe the inflammatory reaction of pathological section.
Result shows, if the inflammatory reaction implanting the pathological section of the rabbit of compound hernia sticking patch prepared by embodiment of the present invention 1-5 is obviously wanted than matched group, inflammatory cell quantity <5 in the visual field, and inflammatory cell quantity >30 in the matched group visual field, therefore, illustrate that conjunction hernia sticking patch content of the present invention obviously reduces the infection of hernia defect.
Therefore, compound hernia sticking patch prepared by the present invention can treat the infection of hernia defect, and reduces cicatrization, can keep the mechanical strength of compound hernia sticking patch simultaneously, effectively can reduce the Delayed soreness that hernia is repaired, and solves the problem of easily recurrence.
Applicant states, the present invention illustrates compound hernia sticking patch of the present invention and its preparation method and application by above-described embodiment, but the present invention is not limited to above-described embodiment, does not namely mean that the present invention must rely on above-described embodiment and could implement.Person of ordinary skill in the field should understand, any improvement in the present invention, to equivalence replacement and the interpolation of auxiliary element, the concrete way choice etc. of each raw material of product of the present invention, all drops within protection scope of the present invention and open scope.
Claims (10)
1. a compound hernia sticking patch, it is characterized in that, described compound hernia sticking patch comprises three-decker, is respectively outer biosphere, internal layer supporting layer and outer biosphere from bottom to top, described outer biosphere is de-cytoskeleton layer, and described internal layer supporting layer is polylactone mesh sheet layer.
2. compound hernia sticking patch according to claim 1, is characterized in that, described de-cytoskeleton is that cattle bladder takes off cytoskeleton, pig small intestine take off cytoskeleton or Vesica sus domestica takes off the combination of any one or at least two kinds in cytoskeleton.
3. compound hernia sticking patch according to claim 1 and 2, is characterized in that, the hole of described outer biosphere is 20 μm-500 μm;
Preferably, the thickness of described outer biosphere is 200 μm of-2mm, preferred 200-800 μm.
4. the compound hernia sticking patch according to any one of claim 1-3, is characterized in that, the polylactone monofilament that described polylactone mesh sheet is 0.3-0.6mm by diameter weaves, and pitch-row is 2-5mm;
Preferably, described polylactone monofilament is selected from the combination of any one or at least two kinds in polycaprolactone glycolide copolymer monofilament, PGA monofilament, polylactide-co-glycolide monofilament or polydioxanone monofilament.
5. the preparation method of the compound hernia sticking patch according to any one of claim 1-4, is characterized in that, said method comprising the steps of:
(1) outer biosphere is laid on substrate, outer biosphere is placed internal layer supporting layer, then on internal layer supporting layer, place another outer biosphere, the two ends of the three-decker tiled and substrate are fixed;
(2) three-decker be fixed on substrate that step (1) obtains is soaked in impregnation liquid, and afterwash impregnation liquid, the outer biosphere in the end placed adds another substrate to cover, dry under hot pressing state, take off and obtain described compound hernia sticking patch from substrate.
6. preparation method according to claim 5, is characterized in that, before preparation compound hernia sticking patch, also comprises and outer biosphere and internal layer supporting layer are carried out pretreated step respectively;
Preferably, the pretreatment of described outer biosphere is that outer biosphere is soaked 6-12h in the sodium bicarbonate solution of pH=8-10;
Preferably, the pretreatment of described internal layer supporting layer is that internal layer supporting layer is soaked 10-30min in the hydrochloride buffer of pH=3-5.
7. the preparation method according to claim 5 or 6, is characterized in that, step (1) and step (2) described substrate are any one in glass plate, corrosion resistant plate or physics and chemistry plate;
Preferably, step (1) and the described basic weight of step (2) are 500g-2kg.
8. the preparation method according to any one of claim 5-7, it is characterized in that, step (2) is described soaks for being soak 10-40min in the impregnation liquid of 50%, 60%, 75%, 90% and 95% respectively in the gradient of volumetric concentration in impregnation liquid;
Preferably, step (2) described impregnation liquid is the mixed aqueous solution of ethanol and glycerol, and wherein ethanol and glycerol volume ratio are 1:1-5:1, preferred 4:1;
Preferably, the temperature of step (2) described hot pressing is 40-60 DEG C;
Preferably, step (2) described drying is carried out in vacuum drying oven;
Preferably, the temperature of step (2) described drying is 40-60 DEG C.
9. the preparation method according to any one of claim 5-8, is characterized in that, said method comprising the steps of:
(1) outer biosphere is soaked in the sodium bicarbonate solution of pH=8-10 6-12h and carry out pretreatment, internal layer supporting layer is soaked in the hydrochloride buffer of pH=3-5 10-30min and carry out pretreatment;
(2) pretreated outer biosphere is laid on substrate, outer biosphere is placed pretreated internal layer supporting layer, on internal layer supporting layer, then place another pretreated outer biosphere, the two ends of the three-decker tiled and substrate are fixed;
(3) three-decker on substrate that is fixed on step (1) obtained is soak 10-40min respectively in the impregnation liquid of 50%, 60%, 75%, 90% and 95% in the gradient of volumetric concentration, wherein impregnation liquid is the mixed aqueous solution of ethanol and glycerol, wherein ethanol and glycerol volume ratio are 1:1-5:1, and afterwash impregnation liquid, the outer biosphere in the end placed adds another substrate to cover, dry under hot pressing state in the vacuum drying oven of 40-60 DEG C, then take off from substrate and obtain described compound hernia sticking patch.
10. the application of the compound hernia sticking patch according to any one of claim 1-4 in the material for the preparation of the infection or reduction cicatrization for the treatment of hernia defect.
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| CN105920669A (en) * | 2016-04-25 | 2016-09-07 | 上海卓阮医疗科技有限公司 | Composite extracellular matrix ingredient biological material |
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| CN107335097A (en) * | 2017-06-16 | 2017-11-10 | 卓阮医疗科技（苏州）有限公司 | A kind of composite soft-tissue repair materials of operating handle improvement |
| CN107335097B (en) * | 2017-06-16 | 2020-09-15 | 卓阮医疗科技（苏州）有限公司 | Composite soft tissue repair material with improved operation hand feeling |
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