The content of the invention
The goal of the invention of the present invention, is to overcome the deficiencies in the prior art to be used to treat stress incontinence there is provided one kindNo-station pole canopy suspender system.The no-station pole canopy suspender system includes the suspender belt main body that fiber film layer is constituted, the suspender belt main bodyWith the good performance integrated with autologous tissue, and parcel suspender belt body surfaces sheath, can be to prevent by the sheathOnly cutting of the suspender belt to tissue internal organs in surgical procedure, friction during attenuating suspender belt generation activity to tissue, and be substantially reducedThe resistance that sheath is produced when taking out, substantially increases the convenience and operability of operation.
The above-mentioned purpose of the present invention is achieved by following technical solution：
A kind of no-station pole canopy suspender system, the no-station pole canopy suspender system includes suspender belt main body and cladding suspender belt body tableThe sheath in face；The suspender belt main body is made up of fiber film layer, and the suspender belt main body is latticed for the hollow out being made up of multiple through holesSupporting structure；Hole is provided with the upper surface of the sheath or lower surface.
Preferably, the suspender belt main body is made up of the fiber film layer with biomimetic features.
Preferably, the fiber film layer with biomimetic features is made by fiber accumulations increases material manufacturing technology.
Preferably, the fiber film layer is made by electrostatic spinning technique.
The biomimetic features refer to the structure for simulating natural extracellular matrix.
Through hole in the suspender belt main body, can pass through the method systems such as laser engraving, punching press, the local molten, machine cuts of pressure.Due to having multiple through holes in suspender belt main body, its homotaxis is latticed, thus suspender belt main body is in the latticed support knot of hollow outStructure.
The latticed supporting structure of hollow out in above-mentioned suspender belt main body is designed with beneficial to inducing self-body cell growth, forms connectiveTissue, reinforcing urethra perienchyma, and suspender belt main body have the intensity and elasticity of optimization, at the same the edge designs of the through hole intoArc side or rounding off can be avoided stimulation of the sharp comer to tissue.Prior art is to reduce suspender belt body implant processResistance, being usually chosen in the surface of suspender belt main body increases a sheath.However, existing sheath is typically a complete planeStructure, its contact surface with tissue is very big, therefore during sheath is taken out, by larger resistance.Invention human hairExisting, the providing holes on a face of sheath, it is possible to reduce the contact area of sheath and tissue can substantially reduce sheath and takeThe resistance produced when going out, while can also reduce the resistance in suspender belt implantation process, substantially increases the convenience of suspender belt implant surgeryProperty and operability.
In the present invention, the traction that suspender belt is carried out when people's body activity is mainly included in operation to suspender belt, and in operationAfter finishing, sheath is separated into taking-up from suspender belt main body.
The resistance change that the size in the hole on sheath is produced when being taken out with sheath is inversely proportional, and the area in hole is bigger, shieldResistance when set takes out is smaller.Preferably, the gross area in the hole on the sheath is accounted for where it sheath upper surface or lower surfaceMore than the 10% of the gross area.In order to preferably reach on the resistance in reduction active procedure to tissue, preferably described sheathThe sheath upper surface or the 20% ~ 50% of the lower surface gross area that the gross area in hole is accounted for where it.
The sheath can be integrally formed sheath, can also be made up of two sub- sheaths.In order to preferably make sheathSeparated with suspender belt main body, preferably use the form of sub- sheath.It is thus preferred that the sheath includes being symmetrically distributed in suspender belt masterBody left side and the first sheath and the second sheath of right side；First sheath and the second sheath are respectively by the two of suspender belt main bodyThe center extension to suspender belt main body is held, and the first sheath and the second sheath are each independent；First sheath and the second sheathOn hole position in the same face.
The quantity in the hole on sheath can be one or more.
Preferably, the quantity in the hole on the first sheath or the second sheath is 1 ~ 5.
Preferably, with the second sheath in its adjacent one end there is gap in first sheath.Preferably, the gap away fromFrom for 0.1cm ~ 10cm.
In order to reach preferable autologousization effect, the surface of suspender belt needs to facilitate creeping for cell with certain roughnessAnd grow into；On the other hand, because suspender belt implantation position is urethra and anterior vaginal wall gap, daily routines will cause suspender belt and softnessUrethra directly contact friction, when suspender belt surface roughness is larger, in daily routines, suspender belt will cause abrasion to urethra, longThe abrasion of time would be possible to the generation for causing urethra to corrode.Preferably, the upper surface of the suspender belt main body and lower surface is thickRugosity is 0.1 μm~50 μm.Control can preferably meet cell and creep and grow into the range of this roughness, and reduce and hangAbrasion of the band to urethra.
The shape of through hole in suspender belt main body can be the shape or irregular shape of rule.Preferably, the through holeBe shaped as circular, ellipse or the polygon provided with chamfering.
The aperture of through hole in suspender belt main body is bigger, more can improve the compatibility of no-station pole canopy suspender and tissue, excellentSelection of land, the aperture of the through hole is 1.5 ~ 5mm.It is highly preferred that the aperture of the through hole is 3 ~ 4.5mm.It is highly preferred that described logicalThe aperture in hole is 4mm.
The distribution density of through hole in suspender belt main body has a certain impact to the mechanical property of no-station pole canopy suspender.TypicallyGround, if the open cell content in suspender belt main body excessively can cause the mechanical performance of no-station pole canopy suspender to be decreased obviously.Preferably, instituteDistribution density of the through hole in suspender belt main body is stated for 1 ~ 10/cm2.It is highly preferred that distribution of the through hole in suspender belt main bodyDensity is 2 ~ 8/cm2.It is highly preferred that distribution density of the through hole in suspender belt main body is 3 ~ 6/cm2。
The thickness of suspender belt main body is bigger, and the stimulation to perienchyma is bigger, and complication occurrence probability is higher, and patient is postoperativeTo substantially there is foreign body sensation.But excessively thin suspender belt will cause cutting to perienchyma.
Preferably, the thickness of the suspender belt main body is 0.1mm~1mm.It is preferred that the thickness of suspender belt main body is 0.2 ~ 0.25mm；Because suspender belt implantation position is anterior vaginal wall, for the user of sexual intercourse, thicker suspender belt will make it experience foreign body sensationAnd shouting pain；When the thickness for reducing suspender belt is 0.25mm and is following, patient's foreign body sensation will be significantly reduced.
In order to be more convenient for, doctor is operated, it is preferable that be provided with position line on the sheath.
For integrally formed sheath, in order to which the separation of sheath and suspender belt main body is better achieved, the position line can be madePosition line is cut for sheath, it is preferable that the cutting position line is overlapped with the line of symmetry in the axial direction of suspender belt main body of sheath.
Preferably, the two ends of the no-station pole canopy suspender system are provided with guide wire.The design of guide wire, can be more convenient for operationOperation.Preferably, the junction of the guide wire and suspender belt main body, which is provided with, is used to protect guide wire and the convenient sleeve pipe punctured.LeadLead and the junction of suspender belt main body expose outside, are easily damaged, the life-span of junction can be improved by setting up sleeve pipe.Simultaneously can be justPassed through in harness system in tissue, implantation body.Preferably, described sleeve pipe entire length is 5mm ~ 20mm, more preferablyFor 10mm ~ 16mm；Casing diameter is 2mm ~ 8mm, preferably 3mm ~ 5mm.
The two ends of the no-station pole canopy suspender system are provided with guide wire and sleeve pipe, one end and sheath and the suspender belt of described sleeve pipeMain body is connected, and the other end is in cone-shaped；One end of the guide wire is connected with sheath and suspender belt main body, and the other end passes through sleeve pipeCone shaped end opening is extended to outside sleeve pipe.The sleeve pipe of cone-shaped design, can reduce the resistance of puncture process.
Preferably, one end of described sleeve pipe is connected with sheath and suspender belt main body, and the other end is in bullet shape.The guidingOne end of line is connected with sheath and suspender belt main body, and the open-ended of bullet shape of the other end through sleeve pipe extends to sleeve pipeOutside.Preferably, sleeve pipe is included by being connected with sheath and suspender belt main body Part I in straight tube-like and the in bullet-shapedTwo parts.It is highly preferred that the length of described sleeve pipe Part I is 3mm ~ 17mm, preferably 6mm ~ 13mm.Preferably, described sleeve pipeIt is made up of the fluorinated ethylene propylene copolymer with high gliding surfaces property.The sleeve pipe prepared using above-mentioned shape and material,The damage to tissue and blood vessel in puncture process can be reduced.
In order to preferably reduce resistance of the suspender belt with sheath in people's body activity between tissue, preferably instituteStating sheath has smooth surface, and it is polyethylene or polypropylene that the material of sheath, which is preferably,.
The edge designs curved edge of the suspender belt main body, can be stimulated, with reduction in cutting of the suspender belt edge to tissue lessUrethra and vagina corrode the effect of exposure probability, meanwhile, it is capable to provide certain fixed force for suspender belt.Especially for fiber accumulationsThe suspender belt main body that increases material manufacturing technology is made, because the suspender belt body surfaces that fiber accumulations increases material manufacturing technology is made relatively are put downIt is whole, the burr of suspender belt body surfaces being made in the absence of braiding or overhead kick, therefore hanging of being made of fiber accumulations increases material manufacturing technologyIt is generally relatively low with main body and the fixed force of tissue.And suspender belt body rim is designed to curved edge, then it can lift fiber stackThe fixed force for the suspender belt main body that product increases material manufacturing technology is made.
Preferably, the curved edge is made up of the arc unit of multiple repeated arrangements.Further, each arc unitWidth be 1mm ~ 10mm, preferable width be 3 ~ 7mm；The spacing of two neighboring arc unit is 0mm ~ 10mm, preferably spacingFor 3 ~ 7mm.
The mechanical property requirements of the suspender belt main body may be referred to the mechanical performance of existing suspender belt product, or refer to normal femaleProperty anterior vaginal wall elongation and the urinary incontinence suspention require.Preferably, elongation of the suspender belt main body when bearing 2kg gravityFor 10% ~ 50%, more preferably 15% ~ 30%, more preferably 20% ~ 25%.Within this range, the autologousization energy of suspender belt main body can be improvedPower.The autologousization ability of suspender belt main body is a reflection of suspender belt repairing effect.Autologousization ability is higher, and suspender belt main body is easierCell, tissue is allowed to grow into, the adhesiveness with tissue is strong, and biocompatibility is good, the material and Stability Analysis of Structures of suspender belt, for a long timeWithout material and material the influence biocompatibility newly discharged during use, while having preferable anti-infectious ability.
The assay method of elongation of the suspender belt main body when bearing 2kg gravity is：Suspender belt main body is cut to lengthFor 50mm, wide 11mm batten is measured using universal tensile testing machine, and loading mode is to determine load modes, load valueIt is set as 19.6N, is then clamped the two ends of suspender belt main body batten with the fixture of tensile testing machine, tensile testing machine zeroing is laggardRow tensile test, stretching condition is：Draw speed is that 50mm is per minute, and fixture spacing is 40mm.Suspender belt main body is recorded in 19.6NTensile elongation during pulling force.
Preferably, the width of the suspender belt main body is 7 ~ 15mm.It is preferred that the width of the suspender belt main body is 9mm ~ 11mm.
The material used in the fiber film layer of suspender belt main body of the present invention is prepared, conventional non-degradable material system is usedInto.The non-degradable material mainly includes poly- fluorine class material（PVDF, PTFE etc.）, polyolefin（Polyethylene, polypropylene etc.）, it is poly-Urethane class material（PU, PCU, TPU etc.）Etc. non-degradable material.
It is further preferred that the non-degradable material is made into the material with certain fluffy degree and stability by processing methodMaterial, the soft tissue repair sticking patch as described in CN104645420A possesses good fluffy degree, is conducive to the fast of cell and tissueSpeed adhesion and propagation, guiding cell differentiation, are conducive to being brought into close contact between tissue, while it is in long-term internal fusion and drillsDuring change, the stabilization of pore-size and porosity is kept.
Preferably, the fiber film layer is the tunica fibrosa organization bracket being made up of diameter in 0.01 μm ~ 100 μm of fiber,With vesicular texture, its fluffy degree is 200 ~ 2000cm3/ g, its fiber junction occurs fusion and forms fiber nodes；
The stability S of the organization bracket meets following relation：
,
Wherein T1For organization bracket original depth, T2To measure the thickness of organization bracket, thickness unit after mechanics fatigue testmm；S numerical value is 1 ~ 3.
Stability refers to thickness of the original depth of suspender belt material of main part with measuring suspender belt material of main part after mechanics fatigue testThe ratio between degree.In the Stabilily parameter of described group of suspender belt main body, the test mode of each parameter refers to following method：
The method of testing of the suspender belt material of main part original depth is according to GB using FAST-1 compressibility Fabric Style instrument/ T 7689.1-2001 methods are tested, and represent suspender belt material of main part in 2cN/cm2Thickness under pressure；
The mechanics fatigue test is, according to suspender belt material of main part, in 10MPa tensile strengths, to stretch 500000 times.
It is highly preferred that the fiber film layer is the tunica fibrosa organization bracket being made up of diameter in 0.1 μm ~ 10 μm of fiber.
The fiber junction occurs fusion and forms fiber nodes to occur what fusion was formed at cross-lapping between fiberMacroscopical node that fusion is formed occurs between fiber at side-by-side contact for microcosmic node.
Preferably, the shape of the microcosmic node is in bulk, and average diameter is 10nm ~ 10 μm.
Preferably, macroscopical node is in wire, bulk, and the line width of wire macroscopic view node is 25 ~ 1000 μm；Bulk macroscopic viewThe average diameter of node is 25 ~ 1000 μm.
In the present invention, described bulk, including rule of surface are spherical, or surface imperfection is spherical；The dough isDue to what is agglomerated into after fiber melting.
Preferably, the line width of the macroscopical node of the wire is 50 ~ 500 μm；A diameter of 50 ~ 500 μm of bulk macroscopic view node.
Preferably, the spacing of macroscopical node is 100~5000 μm described in any two.It is highly preferred that described in any twoThe spacing of macroscopical node is 100~1000 μm.
Preferably, the fluffy degree of the fiber film layer is 200 ~ 2000 cm3/g。
Preferably, the pliability of the fiber film layer is 50 ~ 500 milli- newtons.
Preferably, the pliability of the fiber film layer is 200 ~ 450 milli- newtons.
Described fluffy degree and pliability may be referred to CN103800096A, i.e., fluffy degree of the present invention refers to by 0.01μm ~ 1000 times of the apparent thickness of organization bracket that constitutes of 100 μm of fiber and the ratio between surface density, i.e.,
The apparent thickness T of fluffy degree=organization bracket3/ surface density ω × 103,
Wherein, fluffy degree is with cm3/ g represents that apparent thickness is represented with mm, and surface density is with g/m2Represent.Organization bracketApparent thickness T3Method of testing be to be entered using FAST-1 compressibility Fabric Style instrument according to GB/T 7689.1-2001 methodsRow test, is expressed as organization bracket in 2cN/cm2Thickness (mm) and organization bracket are in 100cN/cm under pressure2It is thick under pressureDegree（mm）Difference.Surface density ω test mode is the single face unit of measure in the case where ignoring the thickness of organization bracketWeight under area.
Described pliability refer to according to method is tested out in GB/T 8942-2002 the counter-bending power of organization bracket andOrganization bracket and the maximum vector sum of frictional force at gap, are represented with milli- newton, and the smaller explanation film of softness values is more soft.
The preparation method of suspender belt main fibre film described above, may be referred in CN103800096A, CN104645420AIt is prepared by the method for record.
Compared with prior art, the present invention has the advantages that：
No-station pole canopy suspender system of the present invention, by the design to suspender belt main body and jacket structure, improves and hangsAutologousization performance with product, by the providing holes on a face of sheath, reduces the contact area of sheath and tissue, fromAnd the resistance produced during people's body activity of the suspender belt with sheath is substantially reduced, substantially increase sheath and take out or suspender belt is enteredConvenience and operability during row traction.The suspender belt is during human body is implanted into, and the stimulation to tissue is small, long-term to plantAfter entering, the rapid micropore along between the spinning fibre of suspender belt main body of energy inducing self-body cell grows, and forms connective tissue and simultaneously strengthens urineRoad perienchyma, so that urethra perienchyma recovers or close to normal physiological function, no-station pole canopy suspender of the present inventionSystem can substantially reduce the generation of the complication such as foreign body sensation and erosion, exposure, infection.
Embodiment 2
No-station pole canopy suspender system architecture is identical with structure described in Fig. 1 or Fig. 2 of embodiment 1 described in the present embodiment.
Wherein, the suspender belt main body is the organization bracket being made up of diameter in 0.01 μm ~ 100 μm of fiber, with porousShape structure, its fluffy degree is 200 ~ 2000cm3/ g, its fiber junction occurs fusion and forms fiber nodes；
The stability S of the organization bracket meets following relation：
,
Wherein T1For organization bracket original depth, T2To measure the thickness of organization bracket, thickness unit after mechanics fatigue testmm；S numerical value is 1 ~ 3.Suspender belt main body described in the present embodiment may be referred to the preparation method described in CN104645420APrepare.
It is believed that the suspender belt main body with above-mentioned performance has more preferable mechanical property and repairing performance.
Comparative example 1
The no-station pole canopy suspender system of this comparative example is removed and is not provided with hole on sheath（That is the upper and lower surface of sheath is closed wholeBody）Outside, remaining structure is identical with the structure described in Fig. 1 of embodiment 1.
Resistance measurement experiment is carried out as follows：
The suspender belt main body of sheath will be coated with from long 25cm, thickness passes through for 8cm leptobos cube meat center.Put on beefWeight is put, during for simulating surgical procedure suspender belt through human body, the oppressive force of muscle and fascia tissue to suspender belt.Then by suspender beltThe part that main body is exposed outside beef is cut, and keeps remaining part motionless, and the slow guide wire that draws is by sheath and unnecessary suspender belt masterBody portion is extracted out, the mechanics numerical value in reading pointer type pull and push dynamometer, by reset key zero after record, starts next group of test.
The resistance measurement result for taking out sheath is as shown in table 1
Table 1
Structure of the present invention is can be seen that from above-mentioned contrast, power used when taking out sheath can be reduced.Therefore moreIt is easy to operation.
Stressing conditions when sheath takes out from tissue are as shown in Figure 6.Due to that would generally be sent out in suspender belt implantation processIt is raw to fold, therefore need to overcome the multiple action power of sheath and tissue, sheath and suspender belt main body during taking-up.Fig. 6 a exhibitionsShow with the stressing conditions with the sheath described in comparative example 1.State of the suspender belt in folding in tissue, the severing at CAfterwards, when taking out sheath, the contact surface of every layer of sheath and suspender belt main body can all produce frictional force, now, and sheath is taken out toward D directionsDuring from human body, sheath is F by the frictional force of suspender belt main bodyRub= 4μFPressure（In formula, FRubThe friction of suffered suspender belt main body is taken out for sheathPower, μ is coefficient of friction, FPressureFor suspender belt pressure）, Fig. 6 b displayings with the stressing conditions of the sheath with structure shown in Fig. 1, whenBehind the upper surface of sheath or lower surface perforate, sheath is folded in implantation process to the one side provided with perforate, now takes out sheathWhen sheath by frictional force be FRub= 2μFPressure.It can be seen that, set on a face of sheath after perforate, the frictional resistance of sheath is notableReduce.Therefore the porose frictional force for being designed to eliminate suspender belt folded interior is set on a face of sheath, so as to subtractPower used during sheath is taken out less.
Embodiments of the invention are the foregoing is only, are not intended to limit the scope of the invention, it is every to utilize this hairEquivalent structure or equivalent flow conversion that bright description is made, or directly or indirectly it is used in other related technology necksDomain, is included within the scope of the present invention.