CN206587207U - Compound hard brain or spinal meninges implant - Google Patents
Compound hard brain or spinal meninges implant Download PDFInfo
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- CN206587207U CN206587207U CN201621111231.0U CN201621111231U CN206587207U CN 206587207 U CN206587207 U CN 206587207U CN 201621111231 U CN201621111231 U CN 201621111231U CN 206587207 U CN206587207 U CN 206587207U
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Abstract
The utility model is related to a kind of for being implanted into hard brain or the reparation of spinal meninges defect and regenerating compound hard brain or spinal meninges implant of hard brain or mater tissue and preparation method thereof, the porous layer of implant first promotes bone tissue to be formed as osteoconductive scaffold, second porous layer promotes the reparation and regeneration of hard brain or spinal meninges as the cytoskeleton of regeneration collagen, and intermediate layer prevents cerebrospinal fluid excessive.Compound hard brain or spinal meninges implant of the present utility model can effectively facilitate hard brain or spinal meninges regeneration and and bone combination.
Description
Technical field
The utility model belongs to field of biomedicine technology, and be related to one kind is used to repair or regeneration of damaged in surgical operation
Compound hard brain or the spinal meninges implant of hard brain or mater tissue.For more precisely, the utility model is related to one kind by porous material
Expect compound hard brain or the spinal meninges implant being made.
Background technology
The brain and spinal cord of people is covered by hard brain/spinal meninges (hereinafter referred to as hard brain or spinal meninges), its integrality Central nervous
Normal work it is most important.It is human brain structural representation as shown in Figure 1.Hard brain or spinal meninges are by three layers of overlapped tissue structure
Into being respectively from outside to inside：Endocranium, arachnoid and pia mater.Hard brain or spinal meninges refer between skull and brain, and backbone
One layer of dura mater between spinal cord.When the hard brain of people or the integrality of spinal meninges are by premeditated or accidental damage, if hard brain or
Spinal meninges is not timely repaired, and consequence will be very serious.
Clinically, wound, inflammation, tumor operation and birth defect may all cause hard brain or spinal meninges impaired.Neurosurgery
Operation imperfect can cause the complication such as cerebrospinal fluid seepage, infection, meningitis and epilepsy to hard brain or spinal meninges suture.Hard brain or ridge
Film defect can also cause hernia cerebri, nerve fiber and its overlying tissue adhesion, Pseudomeningocele, cortex scar, leakage of cerebrospinal, with
And the various unpredictable consequences such as the parenchymatous wound infection of brain may be threatened.Therefore, that repairs hard brain or spinal meninges has
Efficacious prescriptions method has huge clinical demand.Over the past decades, a variety of hard brains or mater substitutes (implant) are developed
And applied to clinic.
Brain or spinal meninges plasty firmly is a kind of surgical plastic or reconstruction operations carried out on hard brain or spinal meninges.Repair hard brain
Or spinal meninges defect needs a kind of hard brain or spinal meninges implant (being often referred to hard brain or spinal meninges sticking patch), such as surgical operation (such as tumour
Excision) or wound caused by hard brain or spinal meninges large defect.In addition, Arnold Chiari deformities, spinal sensory protein, backbone become
The birth defects such as shape also need hard brain or spinal meninges plasty to be treated.
At present, impaired hard brain or spinal meninges is repaired to be implanted into concern is primarily with implantable and/or absorbable hard brain or spinal meninges
Thing, it is transplanted to hard brain or spinal meninges damaged part, may replace and/or regenerating damaged tissue.Hard brain or spinal meninges implant are facing
Both it had been used for hard brain or spinal meninges defect caused by regenerating nerve surgical site infections on bed, and had also been used to prevent cerebrospinal fluid excessive and group
Knit adhesion.
Hard brain or spinal meninges implant are generally made up of following different materials：(1) autologous or allograft；(2) close
Forming material, such as nondegradable expanded PTFE (Gore-Tex) or degradable lactic acid/hydroxyacetic acid copolymerization
Body (Vicryl)；(3) biomaterial, such as collagen from ox/Zhu Deng animal tissues.
There are many problems in current hard brain or spinal meninges implant.First, autologous and allograft donor is very
It is limited.Fascia late and hat shape periosteal tissue are clinically to repair hard brain or the conventional autologous material of spinal meninges defect.And be derived from lyophilized
The hard brain of corpse or spinal meninges graft may then cause Creutzfeldt-Jakob disease (CJD).Due to CJD propagation risk, the hard brain of corpse or ridge
Film product is disabled.Nondegradable synthetic material belongs to bio-inert material, it is impossible to tissue good combination；And can
The synthetic material of degraded would generally produce acidic by-products, may cause inflammatory reaction.In addition, the degraded of degradation material
Speed is difficult to control to, and there is drawback.Excessively formed due to local organization reaction, scar, the original such as meninges inflammation or bleeding risk
Cause, non-degradable and degradable artificial synthetic material have clinically all been rejected and used.It is derived from chitling lower floor mucous membrane and OX-heart
The biomaterial of bag also be used to prepare hard brain or spinal meninges implant.However, this foreign material can not be gradually resorbed, therefore can
The complication such as infection and immunological rejection can be caused.Be derived from the degradable collagen matrix material of ox tendon there is also it is certain the problem of,
The drawback such as being difficult to control to degradation rate, mechanical performance is low and must use suture.
The content of the invention
In order to solve the above problems, the purpose of this utility model is to provide a kind of compound hard brain or spinal meninges implant,
Hard brain or the spinal meninges implant can promote hard brain or spinal meninges to regenerate, but can promote and bone tissue combination, its intermediate layer can also
Prevent cerebrospinal fluid excessive, especially can adapt to the implant in the case where using suture and inapplicable suture.
To achieve these goals, the utility model provides a kind of compound hard brain or spinal meninges implant, including one first
Porous layer, is made up of the non-collagen polymer and osteoacusis material that synthesize；One second porous layer, by the non-collagen polymer synthesized
With collagen composition；One is located at intermediate layer between the first porous layer and the second porous layer, its porosity less than the first porous layer and
Second porous layer, or it is non-porous；When implant is implanted into the hard brain of patient or spinal meninges defect, first porous layer is pasted with bone tissue
Close, second porous layer is fitted with hard brain or spinal meninges；The osteoacusis material of implant promotes bone tissue to grow into the first porous layer, glue
Original promotes hard brain or mater tissue in the reparation and regeneration of the second porous layer；Reduce or prevent cerebrospinal fluid porous from second in intermediate layer
Layer and hard brain or spinal meninges overflow.
When compound hard brain or spinal meninges implant the implantation hard brain of patient or spinal meninges defect, the first porous layer and bone
Tissue laminating, the loose structure of the first porous layer contributes to material after implantation to be combined with bone tissue, and osteoacusis material therein promotees
Enter bone tissue and grow into the first porous layer；Second porous layer is fitted with hard brain or spinal meninges, and the loose structure of the second porous layer contributes to
Material is combined with hard brain or spinal meninges after implantation, and collagen therein promotes the reparation and regeneration of hard brain or mater tissue；Intermediate layer without
The material of hole or low porosity then reduces or prevented cerebrospinal fluid from being overflowed from the second porous layer and hard brain or spinal meninges.
Preferably, the non-collagen polymer of the synthesis is PAEK (PEAK), polyethylene (PE), poly terephthalic acid
Glycol ester (PET), polymethyl methacrylate (PMMA), expanded PTFE (ePTFE), PLA (PLA), PVOH
Sour (PGA) or Poly(D,L-lactide-co-glycolide (PLGA).
It is highly preferred that PAEK (PEAK) is polyether-ether-ketone (PEEK) or PEKK (PEKK).The polyethylene
(PE) it is ultra-high molecular weight polyethylene (UHMWPE).The collagen is derived from the tissue of ox or pig.
First porous layer is made up of the fiber containing non-collagen polymer, and fiber includes the painting with osteoacusis material
Layer.
Second porous layer is made up of the fiber containing non-collagen polymer, and fiber includes the coating with collagen.
Preferably, the non-collagen polymer of the synthesis is PEKK (PEKK) or ultra-high molecular weight polyethylene
(UHMWPE)。
Preferably, the porosity of first porous layer and second porous layer is 20-90%；It is highly preferred that described
Porosity is 30-80%；It is further preferred that the porosity is 40-70%.
Preferably, the aperture of first porous layer and second porous layer is 10-1000 microns；It is highly preferred that institute
Aperture is stated for 20-800 microns；It is further preferred that the aperture is 50-500 microns.
Preferably, the porosity in the intermediate layer is 0-10%.
Preferably, the osteoacusis material includes bone-like apatite stone material or calcium phosphate material.
Preferably, the non-collagen polymer in the intermediate layer infiltrates through first in the interface in the first porous layer and intermediate layer
The hole of porous layer.
Preferably, the non-collagen polymer in the intermediate layer infiltrates through second in the interface in the second porous layer and intermediate layer
The hole of porous layer.
The preparation method of above-mentioned compound hard brain or spinal meninges implant, comprises the following steps：
The one side of first porous polymeric nitride layer and third polymer layer is combined closely；
The another side of second porous polymeric nitride layer and third polymer layer is combined closely；
The third polymer layer is that non-porous or its porosity is sufficiently low, so as to prevent cerebrospinal fluid excessive；With
First porous polymeric nitride layer is impregnated into osteoacusis material, the second porous polymeric nitride layer dipping collagen-based materials.
Wherein, the first porous polymeric nitride layer is with the method that the third polymer layer is combined：Heat described first
Porous polymeric nitride layer or the third polymer layer, and apply to the first porous polymeric nitride layer and the third polymer layer
Pressure, so that the polymeric material of third polymer layer is infiltrated through in the hole of the first porous polymeric nitride layer.
Wherein, the second porous polymeric nitride layer is with the method that the third polymer layer is combined：Heat described second
Porous polymeric nitride layer or the third polymer layer, and apply to the second porous polymeric nitride layer and the third polymer layer
Pressure, so that the polymeric material of third polymer layer is infiltrated through in the hole of the second porous polymeric nitride layer.
Wherein, the second porous polymeric nitride layer is impregnated with collagen solution or dispersion liquid.
Specific method is：The second porous polymeric nitride layer is impregnated in collagen solution or dispersion liquid, then using vacuum
Second porous polymeric nitride layer described in oven drying.
Preferably, the collagen content of the collagen solution is 0.01-5wt%.
Wherein, the first porous polymeric nitride layer is impregnated with the solution of calcium ions and phosphate anion.
Specific method is：First porous polymeric nitride layer is soaked in containing calcium salt and phosphatic solution, or successively used
Calcium salt soln and phosphate solution immersion.
Wherein, the calcium salt is one or more combinations in calcium chloride, calcirm-fluoride, CaCl2.
Preferably, the concentration of the calcium salt soln is calculated as 0.001-1mol/L with calcium ion.
Preferably, the concentration of the phosphate solution is calculated as 0.001-1mol/L with phosphate radical.
The utility model separately provides a kind of compound hard brain or spinal meninges implant as preparation and treats pachymeninx defect
The application of product.
Compound hard brain or the spinal meninges implant that the utility model is provided is implanted into compound at the hard brain of patient or spinal meninges defect
The method of the hard brain of type or spinal meninges implant：
Compound hard brain or spinal meninges implant is implanted at the hard brain of patient's brain or spinal meninges defect；
Hard brain or spinal meninges defect and the non-collagen polymer containing synthesis and the bottom porous layer of the implant of collagen
Contact, collagen promotes hard brain or the reparation of spinal meninges and the regeneration of bottom porous layer inner tissue；
Bone tissue and the non-collagen polymer containing synthesis and the top porous layer of the implant of osteoacusis calcium phosphate material
Contact, promotes bone growth to enter top porous layer, top porous layer and skull tissue is combined as a whole, and
The intermediate layer of the non-collagen polymer containing synthesis between the porous layer of top and bottom is used to prevent brain ridge
Liquid is excessive.
Wherein, implant is sized for implantation site.
Wherein, collagen promotes fibroblast activity and as the cytoskeleton for storing new collagen.
Implant surgery uses or implant can be fixed on into affected part without using suture.
The bone tissue of regeneration or the thickness of bone-conduction structure can reach 1mm or more.
Hard brain or spinal meninges plasty refer to repair hard brain or spinal meninges using hard brain or spinal meninges implant on hard brain or spinal meninges
The surgical plastic or reconstruction operations of defect.Hard brain or spinal meninges implant can be thin films, and size just covers hard brain or ridge
Film defect.Hard brain or spinal meninges implant are fixed on by hard brain or spinal meninges defect by operation of opening cranium.Hard brain or spinal meninges
The purpose of implant is to repair damaged tissues, or the new tissue of regeneration, or both all have.
At present, impaired hard brain or spinal meninges is repaired to substitute concern is primarily with implantable and/or absorbable hard brain or spinal meninges
Thing.Hard brain or spinal meninges implant clinically both be used to preventing that the cerebrospinal fluid after neurosurgery is excessive, tissue adhesion, again
It is used for the hard brain of regeneration of damaged or spinal meninges.
Hard brain or spinal meninges implant have some following key character：(1) hard brain or spinal meninges implant must be able to prevent brain ridge
Liquid is excessive.Cerebrospinal fluid refers to a kind of limpid colourless body fluid in brain and spinal cord.Cerebrospinal fluid is filled inside and outside whole brain and backbone
Cavum subarachnoidale (hole between arachnoid and pia mater) and ventricular system.(2) hard brain or spinal meninges implant must have
Standby durability, robustness and pliability.Durability refers to postoperative in the preoperative can effectively bear abrasion, pressure and various operations.
Pliability or flexibility no less important, because implant must comply with the group at implant-endocranium interface and implant-skull interface
Knit surface.(3) hard brain or spinal meninges implant should also be in endocranium face and skull face and tissue good combinations.It is good in endocranium face
It is good combine contain by collagen in implant outgrowth so as to which promotion organization regenerates；In skull face, implant should promote bone
It is organized in growth in implant.(4) if implant can gradually degrade more preferably with regeneration.(5) hard brain or spinal meninges implantation
Thing for example low infection risk, should be reacted without immune response, foreign according to there is good biocompatibility.(6) hard brain or spinal meninges are planted
Flexible should be had in surgical procedures by entering thing.It can especially be fitted in the case where using suture and inapplicable suture
Should.
A kind of compound hard brain or spinal meninges implant that the utility model is related to has above section or whole advantages.Especially
It is that the utility model includes a kind of compound hard brain or spinal meninges implant, its porous material adjacent with skull contains osteoacusis
Support can promote bone tissue to be grown into implant, and its porous material adjacent with hard brain or spinal meninges, which contains, can promote collagen regeneration
Support, its intermediate layer can prevent cerebrospinal fluid excessive.Bone conduction effect refers to bone tissue in a certain superficial growth, for example, many
The internal pore surface growth of Porous materials.
The beneficial effects of the utility model are：
The utility model provides a kind of compound hard brain or spinal meninges implant, and compound hard brain or the spinal meninges implant can
Promote hard brain or spinal meninges to regenerate, but can promote and bone tissue combination, and it is excessive to be also prevented from cerebrospinal fluid, especially makes
It can be adapted to in the case of suture and inapplicable suture.
Brief description of the drawings
Fig. 1 is human brain structural representation.
Compound hard brain or spinal meninges implant section between implantation skull and endocranium that Fig. 2 provides for the utility model
Perspective diagram.
Fig. 3 is the enlarged diagram in compound hard brain or spinal meninges the implant section described in Fig. 2, illustrates implant adjacent
The boundary layer of materials at two layers.
Embodiment
The utility model provides a kind of implantable hard brain or spinal meninges implant, includes trilaminate material, its first porous layer
It is made up of the non-collagen polymer and osteoacusis material that synthesize, its second porous layer is by the non-collagen polymer and collagen group that synthesize
Into there is an intermediate layer between the first porous layer and the second porous layer.Hard brain or spinal meninges implant can be that film can also be thin
The form of piece, multilayer material is combined together the thickness for constituting all or part of film or thin slice.
Intermediate layer is non-loose structure, or its porosity is less than the first porous layer and the second porous layer.In the hard brain of patient
Or spinal meninges defect, when carrying out implant surgery, the first porous layer is contacted or adjacent with bone tissue, the second porous layer and hard brain or
Spinal meninges is contacted or adjacent.
Fig. 2 is compound hard brain or spinal meninges implant the elevational cross-section schematic diagram that the utility model is provided, its middle section 100
Including the first porous layer 102, the second porous layer 104, intermediate layer 106.After implantation, the upper surface 108 of the first porous layer 102 and cranium
Bone is contacted, and the lower surface (not shown) of the second porous layer 104 is contacted with hard brain or spinal meninges.First porous layer 102 by containing
The fiber 103 of the non-collagen polymer of synthesis is constituted, and the second porous layer 104 is by the fiber 105 containing the non-collagen polymer synthesized
Constitute.The surface of fiber 103 is osteoacusis material coating, and the surface of fiber 105 is collagenic coating.Intermediate layer 106 is non-porous
The non-collagen polymer material of synthesis.
The thickness of first porous layer 102 is T1, and the thickness of the second porous layer 104 is T2, and the thickness of intermediate layer 106 is T3.T1 is
0.05-3mm, preferably 0.05-1mm, 1-1.5mm, 1.5-2mm, 2-2.5mm, or 2.5-3mm.T2 is 0.05-3mm, preferably
For 0.05-0.5mm, 0.5-1mm, 1-2mm, or 2-3mm.T3 is 0.001-1mm, preferably 0.001-0.01mm, 0.01-
0.1mm, 0.1-0.5mm, or 0.5-1mm.
The non-collagen polymer of synthesis account for most of weight and volume of the first porous layer and the second porous layer.Synthesis
Non- collagen polymer can be taken as matrix, and collagen or mineral can be in the non-collagen polymers of the synthesis of corresponding porous layer
Scattered or distribution.The collagen part by weight of second porous layer can be 0.1-50%, preferably 0.1-1%, 1-5%, 5-10%,
10-20%, 20-30%, 30-40%, or 40-50%.
Mineral promote bone tissue to be grown in the first porous layer hole, and collagen promotes hard brain or spinal meninges in the second porous layer hole
Repaired in gap and regeneration.Reduce or prevent cerebrospinal fluid excessive from the second porous layer or hard brain or spinal meninges in intermediate layer.Also may be used in intermediate layer
To there is certain hole, but porosity must be sufficiently low to prevent cerebrospinal fluid excessive.
Artificial-synthetic copolymer refers to the polymeric material manually prepared, including thermoplastic, thermosetting plastics and bullet
Property body etc..Thermoplastic refers at a certain temperature, for example glass transition temperature (Tg), can possess pliability or plasticity, and
It can solidify after cooling.Thermosetting polymer refers to prepolymer material after irradiating or being heated to certain temperature, cure hard, and
This change is irreversible.Elastomer refers to the polymer with viscoelasticity, that is, refers to stickiness and elasticity, molecular force
Very weak polymer, is compared with other materials, and usual Young's modulus is low, and failure strain power is high.
In some embodiments, the non-collagen polymer of synthesis is PAEK, refers to phenylene ring and passes through oxygen bridge (ehter bond)
The class plastics being formed by connecting with carbonyl (ketone).Poly aryl ether ketone polymer include polyether-ether-ketone, PEKK, polyether ether ketone ketone and
Polyetherketoneetherketoneketone.
Polyether-ether-ketone is the thermoplastic polymer of semicrystalline, high temperature resistant, anticorrosive, good mechanical property.Polyether-ether-ketone
Young's modulus is 3-4GPa, tensile strength 90-100MPa.Glass transition temperature (Tg's) and melting temperature (Tm's) are as shown in table 1.
The glass transition temperature (Tg) of PEKK is 162 DEG C.
In some embodiments, the non-collagen polymer of synthesis is free from the polymer of fluorine.
In other embodiments, the non-collagen polymer of synthesis is polyethylene, and ultra-high molecular weight polyethylene is (for example：), polyethylene terephthalate, polymethyl methacrylate, and expanded PTFE.
The glass transition temperature and melting temperature of the suitable polymeric material in the part of table 1.
The non-collagen polymer of synthesis can also be Biostatic polymer, such as PAEK or polyethylene.Later
Embodiment in, the non-collagen polymer of synthesis is then biological degradation polyalcohol, including but not limited to：It is PLA, left-handed poly-
Lactic acid, left-right rotary mixing PLA, poly- acetic acid alcohol, Poly(D,L-lactide-co-glycolide.Biological degradation polyalcohol refers in contact
Hydrolysis or enzymatic degradation reaction can occur after body fluid, or both the polymer that all has of reaction.It is raw in this patent specification
Thing degradation polymer and biological absorbable, can it is biological absorbing, can bio-digestion be synonym.And Biostatic polymer is not
Can biodegradable polymer.
Mineralogical composition can be bioactivity calcium phosphate compound, for example bone-like apatite stone material.Calcium phosphate material includes
But it is not limited to：One-lime phosphate ((Ca (H2PO4)2), Calcium monohydrogen phosphate (aqueous or not aqueous) (CaHPO4.2H2O or
CaHPO4), tricalcium phosphate (tri basic calcium phosphate or tricalcium phosphate) (Ca3(PO4)2), hydroxyapatite (Ca5(PO4)3(OH)), phosphorus
Lime stone (Ca10(PO4)6(OH,F,Cl,Br)2O), calcium octahate phosphate (Ca8H2(PO4)6.5H2O), biphasic calcium phosphate (tricalcium phosphate and
The two-phase compound of hydroxyapatite), tetracalcium phosphate (Ca4(PO4)2O), amorphous calcium phosphate, or more compound combination.
Collagen can be derived from the structural proteins of a variety of phoirocyte epimatrixs in animal body.For example, pig or cattle tissue
The collagen of middle extraction.
Collagen is triple helix albumen, generally slightly different by two identical chains (α 1) and another chemical constituent
Chain (α 2) composition.The amino acid composition of collagen be atypical protein component, especially its high content hydroxy-proline into
Point.The most common die body of amino acid sequence of albumen is Gly-Pro-X and glycine-X- hydroxy-prolines, wherein X
It is any amino acid outside glycine, proline or hydroxy-proline.
In some embodiments, the first porous layer, up and down the second porous layer or two layers of non-collagen polymer all by synthesizing
The thread tissue layer composition of fiber or yarn of composition.Tissue layer weaves yarn by using different methods or fiber is made,
For example through weft knitting, woollen yarn knitting, braiding and electrospinning etc..Electrospinning is a kind of fiber producing processes, is extracted in a polymer solution using electricity
Powered fiber, or polymer is melted into the fiber to about 10 nanometers of diameter.Electrospinning has electrospray and traditional dry-spinning is fine
The characteristics of dimension.
Medical textile layer can be bought to the Atex Technologies companies of North Carolina.Tissue layer
Loose structure comes from the hole between fabric fibre, and the structure in hole can be open-celled structure.
The fabric for referring to use two yarns to interweave composition at a right angle through weft knitting.Include the warp and transverse direction of transverse direction through weft knitting
Parallel.Latitude and longitude can be the same fiber of identical size or the fiber of obstructed type and size.
Woollen yarn knitting refers to be formed a series of ring using one or a few yarn and constituted fabric.Braiding is by three strands or more
Stock fiber or yarn, which are interweaved, constitutes the structure or decorative pattern of complexity.The usual length of braiding and it is thin, use Z-shaped pigtail method phase mutual respect
Superimposing braid is knitted, and per share fine rule is functionally identical.
Tissue layer can also be non-woven fabrics, broadly be defined as by mechanics, calorifics, chemical mode entangled fiber or fine rule
The fabric or network structure being made.Non-woven fabrics can be smooth porous fabric, be directly prepared into by single fiber, or
It is made up of the plastics or plastic sheeting of melting.Non-woven fabrics can be made up of fiber orient or random.
Multilayer fabric layer can obtain preferable intensity, elongation percentage and other mechanical performances by be combineding with each other.It can pass through
To the different-diameter of fiber, density, direction, and extra machining realizes the control to porosity.
In some embodiments, the first porous layer contains mineral, without collagen.Or, the first porous layer contains ore deposit simultaneously
Thing and collagen.
Mineral can be impregnated into top fabric layer, and mineral coating is formed on the surface of fiber.Mineral can equably immerse top
Portion's porous layer reaches certain thickness.
Collagen can immerse bottom fabric layer, or bottom and top fabric layer.Using above-mentioned similar method, in fiber table
Face forms collagenic coating.Mineral can equably immerse bottom fabric layer up to certain thickness.When top fabric layer includes mineral and glue
When former, mineral coating can cover collagenic coating, and collagenic coating can also cover mineral coating, or form both uniformly or non-uniformly
The coating of mixing.
In other examples, the first porous layer, second porous layer or both be all containing hole, passage or both all
Some porous polymer foams.Foam of polymers can be prepared by capturing gas in polymeric liquid or solid.For example, can
So that under supercritical temperature and pressure, using the synthesis of pore-foaming agent filler, extrusion is mixed, porous polyethers ether is taken out through water extraction after
Ketone.Porous network structure can be open-celled structure, be connected with each other by hole.
Mineral or collagen can be impregnated into polymer foam layer.In some embodiments, mineral or collagen can be overlying on hole
Inwall, so as to be partially filled with the hole of foam of polymers.In some embodiments, the foam of polymers of the first porous layer can be included
Collagen and mineral.Collagenic coating can cover mineral, and mineral coating can also cover both collagen, or formation and uniformly or non-uniformly mix
The coating of conjunction.
Or, mineral, collagen, or both all mixed comprehensively with constituting the non-collagen polymer of synthesis of foam of polymers.
Even before foam of polymers formation or when being formed, mineral or collagen can just be mixed with the non-collagen polymer of synthesis.Example
Such as, the non-collagen polymer and the mixture of collagen of synthesis, or the non-collagen polymer of synthesis and the mixture of mineral can pass through
It is prepared by the mode of melting mixing or solution precipitation.The hole of foam can be formed in preparation process or afterwards.
The intermediate layer of compound hard brain or spinal meninges implant can be also one layer of thin slice or film, its porosity it is very low or
It is non-porous.Thin slice or film can be prepared by the method for melting mixing, such as extrusion molding or injection moulding.Or, it is middle
Layer is the low-down tissue layer of porosity, for example, tissue layer is made up of the fiber of close weave.Thin slice or film can also be obstructed
Cross braiding to be made, for example non-woven fibre.
First porous layer and the second porous layer have porous network structure.Hole may extend over whole porous layer.First is porous
The porosity of layer or the second porous layer is 20-90%, and preferably 30-80%, more preferably 40-70%, average pore size are 10-
1000 microns, preferably 50-800 microns, more preferably 50-500 microns.Intermediate layer can be non-porous structure, or its voidage
It is extremely low, less than 10%, such as 0.01-0.1%, 0.01%-1%, or 1-10%.
The embodiment of the treatment hard brain of patient or spinal meninges defect method is included in the hard brain of patient or the implantation of spinal meninges defect is hard
Brain or spinal meninges implant.Before implantation, a certain proportion of skull tissue around hard brain or spinal meninges defect need to be removed, makes defect portion
Position is exposed.Implant covers hard brain or spinal meninges defect, and implant is suitable to the tissue around affected part.The non-collagen of synthesis
The second porous layer that polymer and collagen are constituted is contacted with hard brain or mater tissue, and fixation implant can be used or without using seam
Line.
After implant is fixed, it can be covered with skull tissue.Skull tissue and the non-collagen polymer containing synthesis
The first porous layer constituted with osteoacusis calcium phosphate material is contacted.
The collagen component of second porous layer contributes to the reparation and regeneration of hard brain or spinal meninges.Collagen is by promoting into fibre
Cellular activity reparation is tieed up with regenerating hard brain or mater tissue, cytoskeleton is served as and new collagen is stored in hole.Osteoacusis phosphorus
Sour calcium material induces bone tissue and grown in the hole of the first porous layer, and the first porous layer is combined with skull tissue tight.
Intermediate layer between first porous layer and the second porous layer also artificial non-collagen polymer, can prevent cerebrospinal fluid from affected part
It is excessive.
It should be prepared first in compound hard brain or spinal meninges implant embodiment many including top porous layer, intermediate layer and bottom
Aperture layer it is composite structured, then by material as described above in operating method impregnate mineral and collagen.
The preparation method of compound hard brain or spinal meninges implant has multiple embodiments, including by the first porous polymeric nitride layer with
The one side of third polymer layer is combined closely, and the another side of the second porous polymeric nitride layer and third polymer layer is combined closely.
First porous polymeric nitride layer is located at the top layer of implant, and the second porous polymeric nitride layer is located at the bottom of implant.
Third polymer layer can be non-porous or its porosity is sufficiently low, so as to prevent cerebrospinal fluid excessive.Preparation method
Further comprise the first porous polymeric nitride layer will be impregnated to osteoacusis material, the second porous polymeric nitride layer dipping collagen-based materials.
In some embodiments, with reference to the method for usable hot pressing.For example, by the first porous polymeric nitride layer and third polymerization
Nitride layer is combined, including heating the first porous polymeric nitride layer or third polymer layer, and to the first porous polymeric nitride layer and trimerization
Compound layer applies pressure, so that the polymeric material of third polymer layer is infiltrated through in the hole of the first porous polymeric nitride layer.
Using similar method, the second porous polymeric nitride layer is combined with third polymer layer, including the second porous polymeric nitride layer of heating
Or third polymer layer, and apply pressure to the second porous polymeric nitride layer and third polymer layer, so that third polymer layer
Polymeric material infiltrate through in the hole of the second porous polymeric nitride layer.So that third polymer layer is porous poly- with first and second
The interface that a polymer is interpenetrated respectively is formed between compound layer.
Fig. 3 is the enlarged diagram in compound hard brain or spinal meninges implant section 100 in Fig. 2, illustrates implant adjacent
The boundary layer of materials at two layers.In Fig. 3, skull, the lower surface of the second porous layer 104 are close in the upper surface 108 of the first porous layer 102
110 are close to hard brain or spinal meninges, and intermediate layer is 106.First porous layer 102 includes boundary layer or interface zone 102a, and second is porous
Layer includes boundary layer or interface zone 104a, and the polymeric material in intermediate layer 106 is scattered in around fiber 103 and 105 respectively.
The outer surface or region of first porous layer 102 and the porous layer of the second porous layer 104 have no polymeric material.First porous layer 102
Thickness T1 includes 102a thickness T1a and the thickness T1b of extraneous surface layer；The thickness T2 of second porous layer 104 includes 104a thickness
T2b and extraneous surface layer T2b.
The second porous polymeric nitride layer can be impregnated in collagen solution or dispersion liquid by the second porous layer, then using vacuum
Second porous polymeric nitride layer described in oven drying is obtained.Dipping refers to polymer architecture fully soaking collagen solution, made porous
The surface of layer forms collagen and mineral coating.Or, the second porous layer is only soaked in collagen solution or dispersion liquid, makes its surface
Form collagenic coating.The collagen content of collagen solution is 0.01-5 wt%, 0.05-2wt%, 0.1-1wt%, or 2-10%.
Calcium salt and phosphate solution can be used to impregnate the acquisition of the first porous polymeric nitride layer for first porous layer.First porous polymeric
The dipping of nitride layer can be used to be soaked containing calcium and phosphate solution.Or successively using the solution containing calcium salt and phosphate solution leaching
Bubble is rinsed.In the temperature exposed to 25-110 DEG C or afterwards, composite construction is toasted.Calcium salt is calcium chloride, calcirm-fluoride, nitridation
The combination of calcium or more compound.Phosphate is ammonium phosphate or phosphoric acid.
The concentration of calcium salt is 0.001-1mol/L, 0.001-0.05mol/L or 0.002-0.01mol/L.It is phosphatic dense
Spend for 0.001-1mol/L, 0.001-0.05mol/L or 0.001-0.01mol/L.
Unless stated otherwise, the definition of following vocabulary is all as follows：
All quantitative values are all " approximate numbers ", regardless of whether expressing." approximate number " refers to numerical value about, that is, professional
Think the numerical value being equal with desired value (for example：Function or result are equivalent).In many cases, " approximate number " represents to round up
Arrive with the immediate value of desired value.
" approximate number " can also refer to above and below a certain quantitative value, including：± 1%, ± 5%, ± 10%, ± 20%.For example：About
10mm (± 10%) refers to 10mm, from 9mm to 11mm, from 9mm to 10mm, or from 10 mm to 11mm.
Specific data interval includes all values in data area two ends and interval.
It is professional although disclosing the part for belonging to different, feature and/or the appropriate dimension of specification, interval and/or value
Whether dimension, interval and/or value and the value of disclosure needed for personnel can judge under the prompting of context are deviated.
Typically include herein and in claims using "or" " and or " two layers of meaning, unless otherwise indicated.
Embodiment 1
A kind of compound hard brain or spinal meninges implant being made up of three layers of PEKK material：The polyether-ketone of first porous layer
Ketone fabric face has osteoid apatite coating, and porosity is 50%, thickness 2mm；The PEKK fabric pore rate in intermediate layer is
0, thickness 0.5mm；The PEKK fabric face of second porous layer has type i collagen coating, porosity 50%, thickness 1mm.
Embodiment 2
A kind of compound hard brain or spinal meninges implant being made up of three layers of superhigh molecular weight polyethylene material：First porous layer
It is DSM N. V.Fabric, its surface is osteoid apatite coating, porosity 60%, thickness 2mm；Intermediate layer is
Superhigh molecular weight polyethylene material, porosity is 0.1%, thickness 0.5mm；Second porous layer isFabric, its table
Face is type i collagen coating, porosity 60%, thickness 1.5mm.
Embodiment 3
A kind of compound hard brain or spinal meninges implant being made up of three layers of polyetheretherketonematerials materials：First porous layer is polyethers ether
Ketone fabric, its surface is osteoid apatite coating, porosity 50%, thickness 1.5mm；Intermediate layer is polyetheretherketonematerials materials, hole
Rate is 0.05%, thickness 0.5mm；Second porous layer is polyetheretherketonematerials materials, and its surface is I Collagen Type VI coatings, porosity
50%, thickness 1mm.
Embodiment 4
Compound hard brain or the spinal meninges implant that one kind is made up of three strata methyl methacrylate (PMMA) materials：First
Porous layer is polymethyl methacrylate fabric, and its surface is osteoid apatite coating, porosity 30%, thickness 2.5mm；It is middle
Layer is polymethyl methacrylate materials, and porosity is 0.01%, thickness 0.1mm；Second porous layer is poly-methyl methacrylate
Ester fabric, its surface is type i collagen coating, porosity 30%, thickness 0.5mm.
Embodiment 5
Compound hard brain or the spinal meninges implant that one kind is made up of three strata ethylene glycol terephthalate (PET) materials：
First porous layer is PET fabrics, and its surface is osteoid apatite coating, porosity 40%, thickness 1.5mm；Intermediate layer is PET materials
Material, porosity is 0.08%, thickness 0.5mm；Second porous layer is PET fabrics, and its surface is type i collagen coating, porosity
40%, thickness 0.5mm.
The preparation method of compound hard brain or the spinal meninges implant of embodiment 6
The method for preparing the hard brain of polyether-ether-ketone (PEEK) or spinal meninges implant of embodiment 3, comprises the following steps：
Step 1：PEEK fabrics are made in electrospinning PEEK fibers；
Step 2：One layer of densification, the PEEK films of low porosity are added in the middle of two layers of PEEK fabric up and down
Step 3：Use more than ultra-sonic welded three layers of PEEK materials, it is ensured that middle PEEK films and two-layer fabrics up and down is close
With reference to；
Step 4：The sulfuric acid solution that the three layers of PEEK materials immersion concentration combined closely by more than is 80wt% 1 minute；
Step 5：The one side of PEEK materials is soaked in the calcium ion containing 2.0mM and 1.0mM phosphate anion solution 5
My god；
Step 6：The another side of PEEK materials is soaked in the solution 1 day containing 5% type i collagen；
Step 7：Cleaning, dry, packaging, and the PEEK materials for sterilizing above step preparation using epoxy second ring are produced.
The preparation method of compound hard brain or the spinal meninges implant of embodiment 7
Prepare the side of compound hard brain or the spinal meninges implant of ultra-high molecular weight polyethylene (UHMWPE) material of embodiment 2
Method, comprises the following steps：
Step 1：PurchaseThe commercially available UHMWPE fabrics of fibrage；
Step 2：One layer of densification, the UHMWPE films of low porosity are added in the middle of two layers of UHMWPE fabric up and down；
Step 3：Use more than 90 DEG C of high temperature bonds three layers of UHMWPE materials, it is ensured that middle UHMWPE films and up and down two
Layer fabric tightness is combined；
Step 4：Three layers of UHMWPE materials combining closely are soaked in the solution 4 hours containing 10M sodium hydroxides by more than；
Step 5：Above UHMWPE materials are handled using oxygen plasma 30 minutes；
Step 6：The phosphate anion that the one side of UHMWPE materials is soaked in into the calcium ion containing 2.0mM and 1.0mM is molten
Liquid 5 days；
Step 7：The another side of UHMWPE materials is soaked in the solution 1 day containing 5% type i collagen；
Step 8：Cleaning, dry, packaging, and using epoxy second ring sterilize more than step played the UHMWPE materials of preparation both.
The utility model is applied to a variety of modifications, form and specification, and its example is shown in figure, and will be hereinafter detailed
It is thin to illustrate.But, its purpose is not limited to various aspects described by above example.On the contrary, its purpose covers this practicality newly
All modifications, equivalent and substitute in the spirit and scope of type.
Claims (21)
1. a kind of compound hard brain or spinal meninges implant, it is characterised in that including：
One first porous layer, is made up of the non-collagen polymer and osteoacusis material that synthesize；
One second porous layer, is made up of the non-collagen polymer and collagen that synthesize；
One is located at the intermediate layer between the first porous layer and the second porous layer, is made up of the non-collagen polymer synthesized, its hole
Rate is less than the first porous layer and the second porous layer, or non-porous；
When implant is implanted into the hard brain of patient or spinal meninges defect, first porous layer is fitted with bone tissue, second porous layer
Fitted with hard brain or spinal meninges；
The osteoacusis material of implant promotes bone tissue to grow into the first porous layer, and collagen promotes hard brain or mater tissue more than second
The reparation and regeneration of aperture layer；
Reduce or prevent cerebrospinal fluid from being overflowed from the second porous layer and hard brain or spinal meninges in intermediate layer.
2. compound hard brain or spinal meninges implant as claimed in claim 1, it is characterised in that the non-collagen polymerization of the synthesis
Thing is PAEK, polyethylene, polyethylene terephthalate, polymethyl methacrylate, expanded PTFE, poly- breast
Acid, polyglycolic acid or Poly(D,L-lactide-co-glycolide.
3. compound hard brain or spinal meninges implant as claimed in claim 2, it is characterised in that the PAEK is polyethers ether
Ketone or PEKK.
4. compound hard brain or spinal meninges implant as claimed in claim 2, it is characterised in that the polyethylene is supra polymer
Weight northylen.
5. compound hard brain or spinal meninges implant as claimed in claim 1, it is characterised in that the collagen is derived from ox or pig
Tissue.
6. compound hard brain or spinal meninges implant as claimed in claim 1, it is characterised in that first porous layer is by containing non-
The fiber of collagen polymer is constituted.
7. compound hard brain or spinal meninges implant as claimed in claim 6, it is characterised in that the fiber is included to be passed with bone
Lead the coating of material.
8. compound hard brain or spinal meninges implant as claimed in claim 1, it is characterised in that second porous layer is by containing non-
The fiber of collagen polymer is constituted.
9. compound hard brain or spinal meninges implant as claimed in claim 8, it is characterised in that the fiber, which is included, carries collagen
Coating.
10. compound hard brain or the spinal meninges implant as described in claim 6 or 8, it is characterised in that the non-collagen of the synthesis
Polymer is PEKK.
11. compound hard brain or the spinal meninges implant as described in claim 6 or 8, it is characterised in that the non-collagen of the synthesis
Polymer is ultra-high molecular weight polyethylene.
12. compound hard brain or spinal meninges implant as claimed in claim 1, it is characterised in that first porous layer and institute
The porosity for stating the second porous layer is 20-90%.
13. compound hard brain or spinal meninges implant as claimed in claim 12, it is characterised in that the porosity is 30-
80%.
14. compound hard brain or spinal meninges implant as claimed in claim 12, it is characterised in that the porosity is 40-
70%.
15. compound hard brain or spinal meninges implant as claimed in claim 1, it is characterised in that first porous layer and institute
The aperture for stating the second porous layer is 10-1000 microns.
16. compound hard brain or spinal meninges implant as claimed in claim 15, it is characterised in that the aperture is that 20-800 is micro-
Rice.
17. compound hard brain or spinal meninges implant as claimed in claim 15, it is characterised in that the aperture is that 50-500 is micro-
Rice.
18. compound hard brain or spinal meninges implant as claimed in claim 1, it is characterised in that the porosity in the intermediate layer
For 0-10%.
19. compound hard brain or spinal meninges implant as claimed in claim 1, it is characterised in that the osteoacusis material includes
Bone-like apatite stone material or calcium phosphate material.
20. compound hard brain or spinal meninges implant as claimed in claim 1, it is characterised in that the non-collagen in the intermediate layer
Polymer infiltrates through the hole of the first porous layer in the interface in the first porous layer and intermediate layer.
21. compound hard brain or spinal meninges implant as claimed in claim 1, it is characterised in that the non-collagen in the intermediate layer
Polymer infiltrates through the hole of the second porous layer in the interface in the second porous layer and intermediate layer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201621111231.0U CN206587207U (en) | 2016-10-10 | 2016-10-10 | Compound hard brain or spinal meninges implant |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201621111231.0U CN206587207U (en) | 2016-10-10 | 2016-10-10 | Compound hard brain or spinal meninges implant |
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ID=60130848
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|---|---|---|---|
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107913435A (en) * | 2016-10-10 | 2018-04-17 | 北京邦塞科技有限公司 | Compound hard brain (ridge) membrane implant and its preparation method and application |
| EP3386448A4 (en) * | 2015-12-11 | 2019-08-07 | Poly-Med Inc. | Synthetic implant device replicating natural tissue structure and methods of making same |
| CN112190771A (en) * | 2020-10-23 | 2021-01-08 | 扬子江药业集团广州海瑞药业有限公司 | Bone tissue regeneration guide membrane and preparation method thereof |
-
2016
- 2016-10-10 CN CN201621111231.0U patent/CN206587207U/en not_active Withdrawn - After Issue
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3386448A4 (en) * | 2015-12-11 | 2019-08-07 | Poly-Med Inc. | Synthetic implant device replicating natural tissue structure and methods of making same |
| CN107913435A (en) * | 2016-10-10 | 2018-04-17 | 北京邦塞科技有限公司 | Compound hard brain (ridge) membrane implant and its preparation method and application |
| CN107913435B (en) * | 2016-10-10 | 2022-09-09 | 北京邦塞科技有限公司 | Composite type dura mater (spinal) membrane implant, preparation method and use thereof |
| CN112190771A (en) * | 2020-10-23 | 2021-01-08 | 扬子江药业集团广州海瑞药业有限公司 | Bone tissue regeneration guide membrane and preparation method thereof |
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