CN103800942A - Pelvic floor repairing sheet - Google Patents
Pelvic floor repairing sheet Download PDFInfo
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- CN103800942A CN103800942A CN201210457576.1A CN201210457576A CN103800942A CN 103800942 A CN103800942 A CN 103800942A CN 201210457576 A CN201210457576 A CN 201210457576A CN 103800942 A CN103800942 A CN 103800942A
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Abstract
The invention provides a pelvic floor repairing sheet. The repairing sheet comprises a fiber membrane, wherein the fiber membrane at least comprises a first fiber layer with directed orientation and a second fiber layer without orientation. The pelvic floor repairing sheet has excellent biocompatibility, excellent softness and excellent tissue compliance, is beneficial to tissue penetration to form firm repairing, and further has the properties of anti-infection and hemostasis. The pelvic floor repairing sheet can be used for manufacturing a tension-free vaginal tape for treating stress incontinence.
Description
Technical field
The present invention relates to a kind of patch of bio-medical technical field, particularly a kind of pelvic floor patch for pelvic floor obstacle disease.
Background technology
Female pelvic is back-up system at the bottom of the complicated basin being made up of the multilamellar muscle of semiclosed inferior pelvic aperture, fascia, ligament etc., be subject to the impact of the factors such as fertility, disease, aging, pelvic floor soft tissue around weakens the supporting function of pelvic organ, causes occurring various pelvic floor obstacle diseases.Pelvic floor obstacle disease is women's commonly encountered diseases and frequently-occurring disease.Female pelvic floor obstacle disease (Pelvic Floor Dysfunction disease, PFD), claim again pelvic floor defects or pelvic floor supporting tissue lax, main manifestations is prolapsus, bulging (the Pelvic Organ Prolapse of pelvic cavity viscera (as bladder, uterus, rectum, vagina and small intestinal etc.), and stress incontinence (Stress Urinary Incontinence, SUI) POP).POP and SUI are closely related, and women's life and health are caused to serious impact.At present, be first-selected for moderate and above prolapsus person's operative treatment.In operation, apply pelvic floor patch treatment pelvic floor obstacle disease, its effect obtains numerous medical personnel and patient's approval.
While adopting at present pelvic floor patch to carry out operative treatment, sticking patch need to be placed between fascia layer and vagina outer wall to provide certain mechanics to support to treat internal organs prolapsus.Wherein fascia is one deck dense connective tissue that runs through health, and it is holding muscle, muscle group, blood vessel, nerve etc.Fascia is divided into again three-decker, is respectively superficial fascia, deep fascia, interior visceral fascia.Fascia includes closely regularly arranged collagen fiber, and the direction of collagen fiber is along direction of pull, so fascia has very strong unidirectional tensile property.Vaginal wall is made up of mucosa, flesh layer and fibrous tissue film, has a lot of band pleats.Vaginal wall is rich in venous plexus, therefore easily hemorrhage or formation hematoma of Local Damaged wound.So desirable pelvic floor repairing patch should have good biocompatibility, good tissue compliance, good pliability, meet fascia layer and vaginal wall and organize different structures and growth requirement, growing into of the corresponding tissue of guiding rapidly, to recover the support to internal organs at the bottom of basin.
At present, in pelvic floor repair product, the non-degradable net sheet of making as main braided material take polypropylene occupies most market, but this sticking patch exposes comparatively serious untoward reaction gradually, as problems such as erosion, shrinkage, hemorrhage, pain.2005-2007, reports hemorrhage 1000 routine bad use cases, from 2008 to 2010, has 2874 routine bad reports, has caused paying close attention to of society and FDA.FDA is just advising this series products to rise to the III class apparatus of supervision highest level from implanting II class medical apparatus and instruments, and has required relevant producer to provide complete clinical report and market to follow the tracks of report.In January, 2012, order 33 pelvic floor repair sticking patch manufacturers and 7 stress incontinence sticking patch manufacturers of FDA carry out the clinical research of going deep into of product.In June, 2012, company of Johnson & Johnson (Johnson & Johnson) issues bulletin, ends the first quarter in 2013, will suspend in the world all pelvic floor repair products of company.Johnson & Johnson at present, American Medical Systems, C.R.Bard, the companies such as Boston Scientific face the lawsuit that up to a hundred relevant issues cause.
Above untoward reaction, from many-side, is mainly because material itself, technique and modus operandi etc. cause.As hard in the net sheet quality that the materials such as polypropylene are prepared by knitting skill, rough surface, poor with the implant site compliance goodness of fit.This more firmly, more coarse material implants, operative site has comparatively significantly foreign body sensation, and there will be material displacement to cause the extruding of normal position tissue even to be punctured at some patient, occurs serious erosion.And the goodness of fit lower with implant site structure, tissue is grown into poor, and the substantially parcel to material in tissue is combined not closely with material, have in the long run potential safety hazard.In later experiments, also confirm, tissue and net sheet associativity are also bad, take out after material, can relatively easily tissue and net sheet be peeled off, and this is also that polypropylene mesh easily occurs that displacement causes a reason of erosion.
No matter be to corrode or shrinkage, once occur that this problem needs second operation reparation in most situations, or net sheet is thoroughly removed.This will very seriously affect patient's orthobiosis, brings huge wound to patient's psychology, physiology, and a lot of patients can still not feel well and pain after net sheet removes, even normally sitting, or affect love life.
In order to solve the problem of the said goods, in prior art (as CN101773689A), propose to replace traditional weaving method to prepare surgery biological patch with electrostatic spinning.Electrostatic spinning is that one is prepared the simple and effective processing method of polymer superfine fibre, because its superfine fibre preparing can reach micro/nano level, nano bionic rack surface is more smooth, can effectively simulate to a certain extent n cell epimatrix structure, good microenvironment is provided to growth and the climbing of cell.At present this characteristic makes micro/nano fibrous membrane material prepared by electrospinning process be specially adapted to bio-medical field, as the timbering material of biomembrane, drug conveying, organizational project etc. etc.
But conventional electrospinning fiber alignment is out unordered loose, cause electrospinning film mechanical strength poor; Differ greatly with the ordered structure of some somas, as myofibrillar arrangement etc., superficial cell growth, also without orientation, cannot meet pelvic floor fascia tissue compliance and mate requirement.At present can only be used for clinically the lower position of mechanical strength requirement, as skin.In order to improve mechanical property, usual method is to make electrospinning film a little bit thicker (as being greater than 0.5mm), but visible inner blood capillary connectivity is poor in long-term zoopery.
Therefore, the sticking patch obtaining by braiding or general electrostatic spinning technique, its internal approach anisotropy cannot be given fibroblastic growth provider tropism in the time organizing self-regeneration.
Summary of the invention
the problem that invention will solve
For above-mentioned variety of issue of the prior art, the invention provides a kind of pelvic floor repair material, it has good biocompatibility, good tissue compliance and good pliability, quick, the orientation that are beneficial to cell and tissue are grown into form firmly and are repaired, and material is soft to be reduced or avoids postoperative foreign body sensation, further can have the characteristic of infection, hemostasis.
for the scheme of dealing with problems
The invention provides a kind of pelvic floor patch, it is characterized in that, described pelvic floor patch comprises fibrous membrane, and described fibrous membrane at least comprises having the first fibrous layer of directional orientation and the second fibrous layer without orientation.Between the first fibrous layer of described fibrous membrane and the second fibrous layer, can also there is intermediate layer.Described intermediate layer is preferably without orientation fibers layer.
Pelvic floor patch of the present invention, passes through the mode combination of electrostatic spinning, ultrasonic fusion or stitching between each layer of wherein said fibrous membrane.
Pelvic floor patch of the present invention, preferably combines closely by the mode of electrostatic spinning between each layer of wherein said fibrous membrane.For example, when described fibrous membrane is duplicature, be directly transitioned into the second fibrous layer from the first fibrous layer by electrospinning, two-layer combination is closely not stratified.In the time that described fibrous membrane also has intermediate layer, can directly be transitioned into intermediate layer from the first fibrous layer by electrospinning, then to the second fibrous layer.
Pelvic floor patch of the present invention, the mode of one or more in wherein said fibrous membrane process drilling processing, hyperthermic treatment and immersion treatment is processed.
Pelvic floor patch of the present invention, wherein said drilling is treated to punching press drilling, laser punching, local pressure founded hole.
Pelvic floor patch of the present invention, wherein said pelvic floor patch comprises and the membrane-bound mesh grid of described fiber or memory metal.
Pelvic floor patch of the present invention, tinsel or the polymer fiber processing of sewing for wherein said fibrous membrane.
Pelvic floor patch of the present invention, the cellosilk that the first fibrous layer of wherein said fibrous membrane is is 10nm～20 μ m by diameter aligns the layer with cellular three dimensional structure forming; The second fibrous layer of described fibrous membrane is to be the unordered layer with cellular three dimensional structure that interweaves and form of cellosilk of 10nm～20 μ m by diameter; In the time that described fibrous membrane has intermediate layer, it is the unordered layer with cellular three dimensional structure that interweaves and form of cellosilk of 10nm～20 μ m that described intermediate layer is preferably by diameter.
Pelvic floor patch of the present invention, the thickness of wherein said pelvic floor patch is 0.25mm～0.8mm, and the pore size of through hole is 0.4～2mm, and hot strength is 30～80N.
Pelvic floor patch of the present invention, the fibrous material of wherein preparing described fibrous membrane is degradation material, non-degradable material or its combination.
Pelvic floor patch of the present invention, wherein said degradation material is selected one or more in the peptide polymer, chitosan of free polylactic acid, polycaprolactone, polyglycolic acid, Poly(D,L-lactide-co-glycolide, 1,3-PD polymer, collagen protein, gelatin, fibrin, fibroin, elastin mimicry and the group of modification of chitosan composition.
Pelvic floor patch of the present invention, wherein said non-degradable material is selected from one or more in poly-fluorine class material, polyolefin, polyurethane.
Pelvic floor patch of the present invention, wherein said non-degradable material is polyvinylidene fluoride.
Pelvic floor patch of the present invention, contains anti-infection drug, hemostasis class medicine and/or micro-nano granules in wherein said pelvic floor patch.
Pelvic floor patch of the present invention, wherein said anti-infection drug comprises ampicillin class, spiramycin class, sulfonamides, quinolones and/or cephalosporins.
Pelvic floor patch of the present invention, wherein said hemostasis class medicine comprises 6-aminocaprolc acid, para-amino-methyl-benzoic acid, tranamic acid, Radix Notoginseng and/or YUNNAN BAIYAO.
Pelvic floor patch of the present invention, wherein said micro-nano granules comprises SiO
2, TiO
2, ZnO, Ag, Ni, quaternary ammonium salt, chitosan, calcium alginate, polyvinyl alcohol and/or natural macromolecular nanoparticle.
Of the present inventionly it is characterized in that without tension force suspender, describedly use above-mentioned pelvic floor patch preparation without tension force suspender.Preferably, it is used for the treatment of stress incontinence.
the effect of invention
Pelvic floor patch of the present invention has good biocompatibility, good organization's compliance, good pliability, is beneficial to tissue fast and orientation grows into form firmly reparation, effectively reduce or avoid the damage to vagina outer wall, and further thering is the characteristic of infection, hemostasis.Described patch can also be used for making without tension force suspender, in order to treat stress incontinence.
Accompanying drawing explanation
Fig. 1 (A) is that rabbit subcutaneous abdomen Musclar layer is implanted experiment operation photograph
Fig. 1 (B) dissects photograph after rabbit subcutaneous abdomen Musclar layer is implanted March
Fig. 2 dissects photograph after rabbit subcutaneous abdomen Musclar layer is implanted June
Fig. 3 (A) implants experiment operation for vaginal wall and shines
Fig. 3 (B) implants after January and dissects and shine for vaginal wall
Fig. 4 (A) is that the vaginal wall of double-deck fibrous membrane (experimental group) is implanted laboratory sample pathology figure
Fig. 4 (B) is that the vaginal wall of single layer fibre film (matched group 1) is implanted laboratory sample pathology figure
Fig. 4 (C) is that the vaginal wall of polypropylene mesh (matched group 2) is implanted laboratory sample pathology figure
Fig. 5 is the structural representation of double-deck fibrous membrane of the present invention
Fig. 6 is the structural representation that contains medicine without the second fibrous layer of orientation in double-deck fibrous membrane of the present invention
Fig. 7 is the enlarged drawing of I part in Fig. 6
Fig. 8 is the structural representation that all contains medicine in the first and second fibrous layers of double-deck fibrous membrane of the present invention
Fig. 9 is the structural representation of multi-layer fiber film of the present invention
Figure 10 be in multi-layer fiber film of the present invention without orientation the second fibrous layer and intermediate layer in all contain medicine structural representation
Figure 11 is the enlarged drawing of II part in Figure 10
description of reference numerals
In Fig. 1 and 2, (1), (2), (3) are respectively double-deck fibrous membrane (experimental group), single layer fibre film (matched group 1) and polypropylene mesh (matched group 2).
In Fig. 3, white arrow is depicted as double-deck fibrous membrane sample.
A in Fig. 5,6,8-10 is that B is first fibrous layer with directional orientation without the second fibrous layer of orientation, and the C in Fig. 9 and 10 is intermediate layer.
1 finger in Fig. 7 and 11 has the first fibrous layer of directional orientation, and 2 fingers are without the second fibrous layer of orientation, 3 finger medicines.4 finger intermediate layers in Figure 11,5 finger medicines.
The specific embodiment
The invention provides a kind of pelvic floor patch, it is characterized in that, described pelvic floor patch comprises fibrous membrane, described fibrous membrane at least comprise have directional orientation the first fibrous layer, without orientation the second fibrous layer, it meets tissue characteristic, is beneficial to better reparation.Described fibrous membrane may further include intermediate layer.
Pelvic floor patch of the present invention comprises fibrous membrane, and it can be duplicature or multilayer film.Its top layer is first fibrous layer with directional orientation, contacts fascia layer when operation; Bottom is without the second fibrous layer of orientation, contacts vagina outer wall when operation.Between top layer and bottom, can also add the intermediate layer being formed by fiber, preferably wherein comprise medicine and play hemostasis, anti-infective effect.The first fibrous layer has regular fiber orientation, arrangement of collagen fibers direction in simulation fascia inner cell epimatrix, can guide Growth of Cells, for the extracellular matrix of cell and new secretion thereof provides directed skeleton, structure, imitate as far as possible the organizational structure of body self.Can realize good postoperative repairing effect, reduce relapse rate.The second fibrous layer is without orientation fibers layer, meets the architectural feature of vaginal wall outer layer fiber layer, is beneficial to the combination of vaginal wall and product.Intermediate layer is preferably without orientation fibers layer, can, according to different clinical needs, as hemostasis, infection, antiinflammatory etc., load different pharmaceutical.According to different clinical needs, the first fibrous layer of top layer and bottom and the second fibrous layer also can load medicine.
Described fibrolaminar fibrous material can be non-degradable material, degradation material or its combination.Described non-degradable material mainly comprises poly-fluorine class material, as polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE) etc.; Polyolefin, as polyethylene, polypropylene etc.; Polyurethane material, as polyurethanes (PU), polycarbonate polyurethane (PCU), thermoplastic polyurethane (TPU), silicane-modified polyurethane (SPU) etc.Described degradation material mainly comprises the synthetic materials such as polylactic acid (PLA), polycaprolactone (PCL), polyglycolic acid (PGA), Poly(D,L-lactide-co-glycolide (PLGA), 1,3-PD polymer (PDO); Peptide polymer and the natural macromolecular material of collagen protein, gelatin, fibrin, fibroin, elastin mimicry; Chitosan, modification of chitosan.Wherein, the pelvic floor patch that preferably prepared by polyvinylidene fluoride material, it has good histocompatibility and durability, and mechanical strength is good.The fibrous material using in described the first fibrous layer, the second fibrous layer and intermediate layer can be the same or different.
Directional fiber layer described in the present invention refers to that the fiber in this fibrous layer has single orientation, and described refers to that without orientation fibers layer the fiber in this fibrous layer does not have single orientation, comprises the situation such as orientation that random orientation and braiding form.The first fibrous layer of the present invention, the second fibrous layer and intermediate layer can be used above-mentioned fibrous material, for example, by existing Weaving method preparation in prior art, spunbond non-woven technology and loop bonding non-woven technology.Preferably the first fibrous layer by the method for electrostatic spinning prepare have Single Fiber towards directional fiber layer, the second fibrous layer and intermediate layer preferably by the method for electrostatic spinning prepare without orientation fibrous layer.Between each layer of fibrous membrane of the present invention, can directly combine by electrostatic spinning, also can after making respectively each layer, use the mode combinations such as ultrasonic fusion or stitching.
The present invention preferably uses the method for electrostatic spinning to prepare described the first fibrous layer, the second fibrous layer and intermediate layer.Electrostatic spinning can be made the timbering material with enough mechanical strengths, approaches or reaches existing commercially available polypropylene woven net sheet, and reliable physical support effect can be provided in reparation.Main, this electrostatic spinning support is very soft, organizes compliance fairly good.Foreign body sensation is in vivo very low, and can not produce wear phenomenon to surrounding tissue.Meanwhile, tissue and the cell material internal of growing into very soon, later experiments confirm normal structure and material closely chimeric, bond strength is very high, cannot separate both are complete.In the animal body of six months, experiment shows, material and near organize grow into as a whole.The first fibrolaminar structural simulation extracellular matrix structure of the present invention, is extremely beneficial to growing into of fibroblast and blood capillary, and the self-regeneration of muscle, fascia is played a key effect, and can realize repairing effect stable when long.Patch of the present invention assurance is had good biocompatibility and histocompatibility by both above, avoids occurring the erosion of mesh grid sheet, and this is the change of the essence to traditional product.
For the human body autologous tissue structure of more fitting, be beneficial to cell attaching, growth and tissue repair, in preparation process, can adopt multistage process to prepare the fibrous membrane of two kinds of surfaces characteristic of tool simultaneously.This with when operation modes of emplacement match, can reach good result.
In described sticking patch, can contain classes of anti-infective, hemostasis class medicine or micro-and nano-particles.Described anti-infection drug comprises and is not limited to ampicillin class, spiramycin class, sulfonamides, quinolones, the antibiotic such as cephalo-type.Described hemostasis class medicine includes but not limited to 6-aminocaprolc acid, para-amino-methyl-benzoic acid, tranamic acid, Radix Notoginseng, YUNNAN BAIYAO.Described micro-nano granules comprises SiO
2, TiO
2, ZnO, Ag, Ni, quaternary ammonium salt, chitosan, calcium alginate, polyvinyl alcohol, natural macromolecular nanoparticle.Preferably micro-nano granules is chitosan, can play the effect of hemostasis simultaneously.
Pelvic floor patch of the present invention, wherein said fibrous membrane can further pass through post processing modification, for example, can process through one or more the mode in drilling processing, hyperthermic treatment and immersion treatment.As product can change density and the elastic performance of material by stretching.
Described drilling processing can be used punching press drilling, laser punching, local pressure to found the methods such as hole to form the through hole of perforating fiber film upper and lower surface.Wherein preferred laser punching, by regulating and parameters optimization, after cut pore-forming, hole periphery can, by a high temperature moment melting part, become compact texture, and the width of hole periphery puddle is about 0.02 ~ 0.05mm.This puddle can play fixation holes size, maintains the effect of product entirety mechanical property.In the time using electrostatic spinning to prepare fibrous membrane, can be by adopting metal, insulation staggered-mesh dash receiver, the Coulomb repulsion lines that receives strip tool patterning carrys out drilling.
At the bottom of long-term basin, repair system research shows, the aperture of sticking patch is most important to therapeutic effect.And brace aperture rate prepared by traditional electrical spinning process is high, but aperture is very little; And general forming hole method can greatly affect the mechanical property of electrospinning support.The present invention is by research and more different aftertreatment technologys, and through biological experiment in external, body in a large number, draws good, the more soft and good diaphragm material of therapeutic effect of mechanical strength through repeatedly optimizing, and possesses suitable pore size and hole and arranges.As the mode that the hole that adopts certain size is staggered or different size hole combines can be beneficial to better tissue and grow into, in exchanging inside and outside improving material, the quick eliminating of metabolite while being also beneficial to tissue, Growth of Cells.Meanwhile, hole, for tissue growth provides more spaces, is more conducive to penetrating of blood capillary.
The cellosilk that the top layer of fibrous membrane of the present invention is is 10nm～20 μ m by diameter aligns the cavernous three dimensional structure that has forming.The bottom of described fibrous membrane be by diameter be the cellosilk of 10nm～20 μ m unordered be interwoven there is cavernous three dimensional structure.The thickness of described fibrous membrane is preferably 0.25mm～0.8mm, and the pore size of through hole is 0.4～2mm, and the hot strength of fibrous membrane is 30～80N.More preferably the thickness of fibrous membrane is 0.25～0.4mm.For keeping mechanical strength, prepared by the mode that can adopt macropore and aperture to combine: as stamped the macropore of 0.8～2.0mm diameter according to 4～8mm spacing; The wrong aperture of stamping 0.4～0.6mm diameter between around macropore.When can keeping patch mechanical strength like this, increase pore quantity, be more conducive to organize quick perforation growth.
Described pelvic floor patch can also comprise and the membrane-bound mesh grid of described fiber or memory metal.Described fibrous membrane surface can also be with the processing of sewing of tinsel or polymer fiber.
In a specific embodiments of the present invention, using electrostatic spinning to prepare the first fibrolaminar operating condition is 0.1～15.0 ml/hour for regulating the speed of micro-injection pump, regulating the voltage of high tension generator is 15～45kV, regulating the receiving range of receiving system is 15.0～30.0 centimetres, regulate translational speed 1～20 cel of electrospinning syringe needle, receive roller rotating speed and be 2000～6000 circles/point, thereby make the first fibrous layer.
In a specific embodiments of the present invention, using electrostatic spinning to prepare the second fibrolaminar operating condition is 0.1～15.0 ml/hour for regulating the speed of micro-injection pump, regulating the voltage of high tension generator is 15～45kV, regulating the receiving range of receiving system is 15.0～30.0 centimetres, regulate translational speed 1～20 cel of electrospinning syringe needle, dash receiver motionless (receive roller rotating speed be 50～1000 circles/point), thus make the second fibrous layer.
In a specific embodiments of the present invention, high polymer and anti-infection drug can be dissolved in respectively in different solvents to each self-forming homogeneous, stable solution.Then the macromolecular solution of above-mentioned homogeneous and drug solution are respectively charged in different electrostatic spinning syringes, electrospinning makes the second fibrous layer.Then, change condition forms the first fibrous layer on the second fibrous layer, thereby makes double-deck fibrous membrane.In another embodiment, can first prepare the first fibrous layer, then form the second fibrous layer thereon.In such scheme, also can in the first fibrous layer and the second fibrous layer, not add anti-infection drug, and add anti-infection drug in intermediate layer.
In another specific embodiments of the present invention, can use electrostatic spinning to prepare respectively the first fibrous layer and the second fibrous layer, then use ultrasound wave fusion method, the first fibrous layer and the second fibrous layer are combined, form double-deck fibrous membrane.
In addition, in another specific embodiments of the present invention, high polymer is dissolved in solvent and makes uniform solution, then, after polypropylene or other are not degraded or degradation material is made mesh grid sheet are infiltrated in above-mentioned high polymeric solution, take out, dry.Then, above-mentioned net sheet is twisted in and receive roller surface.Above-mentioned high polymeric solution is packed in electrostatic spinning syringe, thereby make the first fibrous layer on described mesh grid sheet.After electrospinning finishes, surface is taken off with the net sheet of electrospinning layer, thereby obtain double-deck fibrous membrane of the present invention.
As shown in Figure 5, double-deck fibrous membrane of the present invention can exemplarily comprise having the first fibrous layer B of directional orientation and the second fibrous layer A without orientation.Wherein can be as shown in Figure 6,7, the second fibrous layer A(2 of nothing orientation) contain medicine 3, and there is the first fibrous layer B(1 of directional orientation) and do not contain medicine, or the bilayer of double-deck fibrous membrane contains respectively identical or different medicine as shown in Figure 8.In addition, as shown in Figure 9, fibrous membrane of the present invention can be multi-layer fiber film, have the first fibrous layer B of directional orientation and without orientation the second fibrous layer A between intermediate layer C is also set.As shown in Figure 10,11, without the second fibrous layer A(2 of orientation) and intermediate layer C(4) identical or different medicine 3 and 5 contained respectively.
For better explanation the present invention, describe in the mode of specific embodiment below, but the present invention is not limited in the concrete mode of embodiment.In the present invention, in the situation that not particularly pointing out, described percentage ratio is mass percent.
Embodiment
The preparation > of < fibrous membrane
The preparation of the double-deck electrospinning film of embodiment 1()
Polyvinylidene fluoride (PVDF) is dissolved in dimethyl acetylamide (DMAc) solvent to the uniform solution that the concentration that forms polyvinylidene fluoride is 20g/100mL.
Then above-mentioned solution is packed in electrostatic spinning syringe, regulating the speed of micro-injection pump is 3 mls/hour, and regulating the voltage of high tension generator is 22kV, and regulating the receiving range of receiving system is 20 centimetres.Receiving system uses live-rollers, translational speed 10 cels of electrospinning syringe needle, receive roller rotating speed and be 4000 circles/point, two pins carry out electrospinning 8 hours simultaneously, thus the first fibrous layer of preparation directional orientation.Then, by rotating speed turn down to 80 circles/point, use equally two pins to carry out electrospinning 8 hours, thus preparation without orientation the second fibrous layer.After end, film is taken off from receiving roller, in vacuum drying oven, solvent is removed in 50 ℃ of insulations.
The preparation of tri-layers of fibrous membrane of embodiment 2()
Polyglycolic acid, polylactic acid are dissolved in respectively to hexafluoroisopropanol (HFIP) and obtain solution a, wherein the concentration of polyglycolic acid is 8g/100mL, and the concentration of polylactic acid is 10g/100mL.
Polyglycolic acid, polylactic acid, medicine Radix Notoginseng are dissolved in to hexafluoroisopropanol and obtain solvent b, wherein the concentration of polyglycolic acid is 6g/100mL, and the concentration of polylactic acid is 8g/100mL, and the concentration of medicine Radix Notoginseng is 10g/100mL.
Then above-mentioned solution a is packed in electrostatic spinning syringe, regulating the speed of micro-injection pump is 2 mls/hour, and regulating the voltage of high tension generator is 15kV, and regulating the receiving range of receiving system is 20 centimetres.Receiving system uses live-rollers, translational speed 3 cels of electrospinning syringe needle, receive roller rotating speed and be 2000 circles/point, two pins carry out electrospinning 3 hours simultaneously, thus the first fibrous layer of preparation directional orientation.Then, change the solution in electrostatic spinning syringe into above-mentioned solution b, by rotating speed turn down to 80 circles/point, use equally two pins to carry out electrospinning 5 hours, thereby electrospinning preparation is without the intermediate layer of orientation.Then, change the solution in electrostatic spinning syringe into above-mentioned solution a, keep receiving roller rotating speed 80 to enclose/point, use two pins to carry out electrospinning 8 hours, thereby electrospinning preparation is without the second fibrous layer of orientation.After end, film is taken off from receiving roller, in vacuum drying oven, solvent is removed in 50 ℃ of insulations.
The preparation of tri-layers of fibrous membrane of embodiment 3()
High polymer polycarbonate polyurethane (PCU) is dissolved in to dimethyl formamide (DMF) and obtains solution a, wherein the concentration of PCU is 12g/100mL.
PCU, medicine ampicillin are dissolved in DMAc and obtain solution b, and wherein the concentration of PCU is 12g/100mL, and the concentration of medicine ampicillin is 15g/100mL.
Then above-mentioned solution a is packed in electrostatic spinning syringe, regulating the speed of micro-injection pump is 12 mls/hour, and regulating the voltage of high tension generator is 42kV, and regulating the receiving range of receiving system is 15 centimetres.Receiving system uses live-rollers, translational speed 26 cels of electrospinning syringe needle, receive roller rotating speed and be 4000 circles/point, two pins carry out electrospinning 2 hours simultaneously, thus the first fibrous layer of preparation directional orientation.Then, change the solution in electrostatic spinning syringe into above-mentioned solution b, by rotating speed turn down to 300 circles/point, regulating the speed of micro-injection pump is 6 mls/hour, uses equally two pins to carry out electrospinning 3 hours, thus electrospinning preparation is without the intermediate layer of orientation.Then, change the solution in electrostatic spinning syringe into above-mentioned solution a, keep receiving roller rotating speed 300 to enclose/point, regulating the speed of micro-injection pump is 12 mls/hour, uses two pins to carry out electrospinning 4 hours, thus electrospinning preparation is without the second fibrous layer of orientation.After end, film is taken off from receiving roller, in vacuum drying oven, solvent is removed in 50 ℃ of insulations.
The preparation of the two-layer fibrous membrane of embodiment 4()
Polycaprolactone (PCL) is dissolved in to hexafluoroisopropanol and obtains solution a, wherein the concentration of PCL is 15g/100mL.
Obtain suspension b to adding nanometer silver (diameter 10 ~ 20nm) in above-mentioned solution a, wherein the concentration of nanometer silver is 10g/100mL.
Then above-mentioned solution a is packed in electrostatic spinning syringe, regulating the speed of micro-injection pump is 6 mls/hour, and regulating the voltage of high tension generator is 25kV, and regulating the receiving range of receiving system is 16 centimetres.Receiving system uses live-rollers, translational speed 10 cels of electrospinning syringe needle, receive roller rotating speed and be 3000 circles/point, two pins carry out electrospinning 5 hours simultaneously, thus the first fibrous layer of preparation directional orientation.Then, change the solution in electrostatic spinning syringe into above-mentioned suspension b, by reception roller rotating speed be down to 200 circles/point, use two pins to carry out electrospinning 6 hours, thus preparation without orientation the second fibrous layer.After end, film is taken off from receiving roller, in vacuum drying oven, solvent is removed in 50 ℃ of insulations.
The ultrasonic fusion method of embodiment 5(is prepared three layers of fibrous membrane)
Thermoplastic polyurethane (TPU) is dissolved in to DMF and obtains the solution that TPU concentration is 14g/100mL.Then above-mentioned solution is packed in electrostatic spinning syringe,
Regulating the speed of micro-injection pump is 4 mls/hour, and regulating the voltage of high tension generator is 20kV, and regulating the receiving range of receiving system is 15 centimetres.Receiving system uses live-rollers, translational speed 10 cels of electrospinning syringe needle, receive roller rotating speed and be 3000 circles/point, two pins carry out electrospinning 6 hours simultaneously, thus the first fibrous layer of preparation directional orientation.
Thermoplastic polyurethane (TPU) is dissolved in to DMF and obtains the solution that TPU concentration is 14g/100mL.Then above-mentioned solution is packed in electrostatic spinning syringe, regulating the speed of micro-injection pump is 3 mls/hour, and regulating the voltage of high tension generator is 25kV, and regulating the receiving range of receiving system is 16 centimetres.Receiving system uses live-rollers, translational speed 10 cels of electrospinning syringe needle, receive roller rotating speed and be 300 circles/point, two pins carry out electrospinning 8 hours simultaneously, thus preparation is without the second fibrous layer of orientation.
Poly(D,L-lactide-co-glycolide (PLGA) and chitosan are dissolved in HFIP, and wherein the concentration of PLGA is 12g/100mL, and the concentration of chitosan is 10g/100mL.Then above-mentioned solution is packed in electrostatic spinning syringe, regulating the speed of micro-injection pump is 2 mls/hour, and regulating the voltage of high tension generator is 30kV, and regulating the receiving range of receiving system is 18 centimetres.Receiving system uses live-rollers, translational speed 15 cels of electrospinning syringe needle, receive roller rotating speed and be 200 circles/point, two pins carry out electrospinning 4 hours simultaneously, thereby make the intermediate layer without orientation.
By above-mentioned, the first fibrous layer, intermediate layer and the second fibrous layer are stacked together in order, then use ultrasonic (the Fu Tan plant equipment company limited of 20000Hz frequency, model JT-200-S), above-mentioned each layer is linked together by the mode of putting ultrasonic fusion every the distances of 10 centimetres.
Embodiment 6(mesh grid is combined with electrospinning)
Polylactic acid (PLA) is dissolved in to HFIP and obtains the solution that concentration is 20g/100mL.After politef mesh grid sheet is infiltrated in above-mentioned high polymeric solution, take out, be dried.Then, above-mentioned net sheet is twisted in and receive roller surface.To net sheet surface sprinkling solvent, make its moistening rear beginning electrospinning slightly.
The hexafluoroisopropanol solution that is 12g/100mL by the concentration of polylactic acid (PLA) packs in electrostatic spinning syringe, regulating the speed of micro-injection pump is 10 mls/hour, regulating the voltage of high tension generator is 26kV, and regulating the receiving range of receiving system is 20 centimetres.Receiving system uses live-rollers, translational speed 10 cels of electrospinning syringe needle, receive roller rotating speed and be 2000 circles/point, two pins carry out electrospinning 4 hours simultaneously, thereby prepare the first fibrous layer of directional orientation on as the second fibrolaminar net sheet.After end, compound film sheet 50 ℃ of insulations in vacuum drying oven are removed to solvent.
Embodiment 7(memory metal)
Patterning prepared by embodiment 3 becomes shape of product, sews up the Nitinol line of upper diameter 0.1mm outward along making a circle with sutures.Under-10 ~ 0 ℃ of low temperature, product can be folded to (as doubling).Be placed on product under 37 ℃ of environment and can automatically recover shape.
Embodiment 8(laser punching)
(large aperture combination)
Three layers of fibrous membrane that embodiment 5 is made, carry out laser punching, and laser power is 50W, cutting speed 10cm/s.From calculating, stamp with laser the macropore that diameter is 2mm every 8mm according to distance of center circle, between each macropore, evenly stamp the aperture that 4 diameters are 0.5mm.
(staggered hole)
Three layers of fibrous membrane that embodiment 5 is made, according to distance of center circle, from calculating, level stamps with laser the hole that diameter is 1.2mm every 5mm, 0.5cm apart between row and row, and hole between two row is staggered, horizontal displacement 2.5mm distance.Wherein, laser power is 40W, and cutting speed is 8cm/s.
< is prepared without tension force suspender >
The fibrous membrane of above-described embodiment 1-8 is cut into 40cm × 1.5cm rectangular, after sterilizing, can be used for the treatment of stress incontinence.
< drug release experiment in vitro >
The fibrous membrane that embodiment 2 is made is cut into 2cm × 2cm square piece, amounts to 20, is divided into 4 groups, uses ethylene oxide sterilizing.Every is immersed in the aseptic phosphate buffer of 10mL (pH=7.4), is placed in 37 ℃ of cell culture incubators, detect respectively at 1 week, 2 weeks, 4 weeks, 8 weeks, adopt high-efficient liquid phase chromatogram technique measuring solution Chinese medicine concentration.Experimental result (in table 1) shows that medicine is since slow release after 1 week, discharges in diaphragm 35% ± 4% medicine by 8 weeks.
Table 1 drug release data table
| Time (week) | 1 | 2 | 4 | 8 |
| Drug accumulation percentage ratio burst size | 10% | 12% | 20% | 35% |
| Error | ±2% | ±2% | ±3% | ±4% |
< cell experiment >
The fibrous membrane that embodiment 1 is made is cut into the disk that diameter is 3cm, uses ethylene oxide sterilizing.Disk is put into cell culture six orifice plates on aseptic operating platform, directional orientation layer is experimental group upward, is matched group upward without oriented layer.Add 2mL people's muscle fibroblast (C2C12) cell suspension, put into 37 ℃ of cell culture incubators and cultivate.Cultivate after 1 week and take out micro-Microscopic observation, the visible a large amount of cells of experimental group are grown along machine direction, and cellular control unit growth is unordered.
< zoopery example >
A. between subcutaneous and Musclar layer, implant experiment (biocompatibility of sample and the experiment of cambium growing state) (seeing Fig. 1, Fig. 2)
Laboratory animal is selected new zealand rabbit, body weight 2.2-2.6Kg, age 6-12 month, totally 12.Experimental rabbit is divided into 2 groups at random, every group of 6 laboratory animals, the body of correspondence 3 and 6 months observation periods is implanted into respectively.Material experiment group is aseptic diaphragm (embodiment 1), and matched group 1 is the unordered fibrous membrane of monolayer, and matched group 2 is polypropylene mesh (Johson & Johnson), and material is all cut to 1cm × 4cm.Implant respectively rabbit subcutaneous abdomen Musclar layer, observe the tissue growth situation of material in 3 months after operation, 6 months.
Method for implantation: remove rabbit abdominal part by hair, sterilization, scalpel cuts skin gently, do not cut muscle, gently carry the other fascia of ventrimeson with Smooth forceps, cut fascia with scalpel along ventrimeson, not muscle injury simultaneously, blade holder passivity separates subcutaneous fascia with muscle, expose suitable material transplanting scope.All laboratory animals are implanted the sample (Figure 1A (2), (3)) of experimental group sample (Figure 1A (1)), matched group 1 and matched group 2 between subcutaneous fascia and Musclar layer.Material is fixed on to corresponding position with No. 4 lines, sews up.
3 months after operation, dissects the 1st group of laboratory animal, and 3 groups of sample biocompatibility are better as seen from Figure 1, and naked eyes are visible, and experimental group surface blood capillary is abundant, and the two sides of all samples all has cambium (Figure 1B) as seen.Observe two-layer diaphragm, it has obvious fiber alignment texture above oriented layer, and omnidirectional layer is without obvious fiber alignment texture.And single layer fibre layer and all unordered growths of polypropylene mesh two covering weaves.
Postoperative 6 months, dissect the 2nd group of laboratory animal (Fig. 2).The associativity of tissues observed and material, on polypropylene material and single layer fibre film, cambium is not found directed texture, and polypropylene material is easy and cambium is peeled off, material internal has no cambium; The visible cambium of the single layer fibre film diaphragm inside of growing into, diaphragm and cambium are more difficult to be peeled off, but it is unordered to grow.Double-deck fibrous membrane is grown into completely by cambium, can not peel off, and the obvious directed texture of cambium as seen on directional fiber layer.
B. vaginal wall is implanted experiment (seeing Fig. 3 and 4)
By the implantation experiment of the capable new zealand rabbit vaginal wall of above-mentioned reparation sticking patch.New zealand rabbit, body weight 2.2-2.6Kg, age 6-12 month, totally 18.Experimental rabbit is divided into 2 groups at random, and 9 every group, the body of correspondence 1 and 3 months observation periods is implanted into respectively.Material experiment group is double-deck fibrous membrane (embodiment 1), and matched group 1 is unordered electrospinning diaphragm, and matched group 2 is polypropylene mesh (Johson & Johnson), and size is 1cm × 1cm.To laboratory animal anaesthetize, preserved skin, lying on the back is bound on plank; Sterilization paving is single, in abdominal part center, with No. 4 scalpels along rabbit hunter's line incision skin and Musclar layer, find bladder, gently draw proposition, take the mesentery between bladder root and uterus as stitch, material is fixed to (Fig. 3 A) with No. 0 line, bladder is sent into abdominal cavity gently, close abdomen.With No. 0 silk thread by sticking patch and muscle interrupted suture around.With No. 4 wire discontinuous sewing skins.
Postoperative rabbit each intramuscular injection penicillin morning and afternoon every day 400,000 units, inject 5 days continuously, and observe the rabbit mental status and appetite when feeding grass every day, and whether occur other diseases.Within postoperative 7th ~ 10 days, take out stitches, detailed observation experiment animal health condition and art portion changes in material in feeding process.Postoperative 1,3 month time, put to death laboratory animal, cut muscle and expose art portion (Fig. 3 B), tissues observed growing state also takes out sample and does pathological section.
Month after operation, after anatomy experiment animal, the material surface of observation experiment group and matched group 1 all has one deck cambium to cover, and in cambium, blood capillary is high-visible, and cambium is combined with material closely; Experimental group material is complied with face, and cambium orientation of growth texture is obviously visible.Matched group 2 material surfaces have the nascent membrane that one deck is very thin to cover, and few blood capillary is grown in nascent membrane, nascent membrane and material easily openable.
3 months after operation, experimental result (in table 2) shows, and experimental group fibrous membrane is integrated with tissue is long, cannot distinguish, and is as good as in appearance with normal surrounding tissue, and alignment layer surface has fiber grain, meets expection rational design (pathology effect is as Fig. 4 A).Experimental group fibrous membrane implant part and surrounding tissue entirety thereof are taken out, and sample softness, without hard thing sense.Pathological section shows that sample inflammatory reaction is lighter, and 3/HPF of foreign-body giant cell <, has no inflammatory granuloma tissue, does not form fibers encapsulation.Matched group 1 sample and basic long being integrated of tissue, there is a small amount of blood capillary on surface, but tissue growth is unordered, and pathological section shows sample inflammatory reaction general (pathology effect is as Fig. 4 B).Grow (pathology effect is as Fig. 4 C) in a organized way in matched group polypropylene mesh surface, but tissue growth is unordered, net sheet with organize layering, both can be peeled off, inflammatory reaction is general.
Table 2. is pathological examination after three months
| ? | Experimental group | Matched |
Matched |
| Inflammation | Gently | Generally | Generally |
| Foreign-body giant cell quantity | < 3/ |
3 ~ 5/ |
5 ~ 8/HPF |
| Tissue growth order | Have | Nothing | Nothing |
| Fissility | Difficult | Difficult | Easily |
Claims (22)
1. a pelvic floor patch, is characterized in that, described pelvic floor patch comprises fibrous membrane, and described fibrous membrane at least comprises having the first fibrous layer of directional orientation and the second fibrous layer without orientation.
2. pelvic floor patch according to claim 1, also has intermediate layer between the first fibrous layer of wherein said fibrous membrane and the second fibrous layer.
3. pelvic floor patch according to claim 1 and 2, passes through the mode combination of electrostatic spinning, ultrasonic fusion or stitching between each layer of wherein said fibrous membrane.
4. pelvic floor patch according to claim 1 and 2, combines closely by the mode of electrostatic spinning between each layer of wherein said fibrous membrane.
5. pelvic floor patch according to claim 2, wherein said intermediate layer is without orientation fibers layer.
6. pelvic floor patch according to claim 1 and 2, the mode of one or more in wherein said fibrous membrane process drilling processing, hyperthermic treatment and immersion treatment is processed.
7. pelvic floor patch according to claim 6, wherein said drilling is treated to punching press drilling, laser punching, local pressure founded hole.
8. according to the pelvic floor patch described in claim 1-7 any one, wherein said pelvic floor patch further comprises and the membrane-bound mesh grid of described fiber or memory metal.
9. according to the pelvic floor patch described in claim 1-7 any one, tinsel or the polymer fiber processing of sewing for wherein said fibrous membrane.
10. according to the pelvic floor patch described in claim 1-7 any one, the cellosilk that the first fibrous layer of wherein said fibrous membrane is is 10nm～20 μ m by diameter aligns the layer with cellular three dimensional structure forming; The second fibrous layer of described fibrous membrane is to be the unordered layer with cellular three dimensional structure that interweaves and form of cellosilk of 10nm～20 μ m by diameter.
11. pelvic floor patch according to claim 2, wherein said intermediate layer is to be the unordered layer with cellular three dimensional structure that interweaves and form of cellosilk of 10nm～20 μ m by diameter.
12. according to the pelvic floor patch described in claim 1-7 any one, and the thickness of wherein said pelvic floor patch is 0.25mm～0.8mm, and the pore size of through hole is 0.4～2mm, and hot strength is 30～80N.
13. according to the pelvic floor patch described in claim 1-7 any one, and the fibrous material of wherein preparing described fibrous membrane is degradation material, non-degradable material or its combination.
14. pelvic floor patch according to claim 13, wherein said degradation material is selected one or more in the peptide polymer, chitosan of free polylactic acid, polycaprolactone, polyglycolic acid, Poly(D,L-lactide-co-glycolide, 1,3-PD polymer, collagen protein, gelatin, fibrin, fibroin, elastin mimicry and the group of modification of chitosan composition.
15. pelvic floor patch according to claim 13, wherein said non-degradable material is selected from one or more in poly-fluorine class material, polyolefin, polyurethane.
16. pelvic floor patch according to claim 13, wherein said non-degradable material is polyvinylidene fluoride.
17. according to the pelvic floor patch described in claim 1-7 any one, contains anti-infection drug, hemostasis class medicine and/or micro-nano granules in wherein said pelvic floor patch.
18. pelvic floor patch according to claim 17, wherein said anti-infection drug comprises ampicillin class, spiramycin class, sulfonamides, quinolones and/or cephalosporins.
19. pelvic floor patch according to claim 17, wherein said hemostasis class medicine comprises 6-aminocaprolc acid, para-amino-methyl-benzoic acid, tranamic acid, Radix Notoginseng and/or YUNNAN BAIYAO.
20. pelvic floor patch according to claim 17, wherein said micro-nano granules comprises SiO
2, TiO
2, ZnO, Ag, Ni, quaternary ammonium salt, chitosan, calcium alginate, polyvinyl alcohol and/or natural macromolecular nanoparticle.
21. 1 kinds without tension force suspender, it is characterized in that, describedly requires the pelvic floor patch preparation described in 1-20 without tension force suspender right to use.
22. is according to claim 21 without tension force suspender, and it is in order to treat stress incontinence.
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| CN201210457576.1A CN103800942B (en) | 2012-11-14 | 2012-11-14 | Pelvic floor patch |
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