CN105250050B - A kind of no-station pole canopy suspender system - Google Patents
A kind of no-station pole canopy suspender system Download PDFInfo
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- CN105250050B CN105250050B CN201510703366.XA CN201510703366A CN105250050B CN 105250050 B CN105250050 B CN 105250050B CN 201510703366 A CN201510703366 A CN 201510703366A CN 105250050 B CN105250050 B CN 105250050B
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Abstract
The present invention discloses a kind of no-station pole canopy suspender system.The no-station pole canopy suspender system includes the sheath of suspender belt main body and cladding suspender belt body surfaces;The suspender belt main body is made up of fiber film layer;The suspender belt main body is provided with the hollow out supporting structure being made up of multiple through holes;Hole is provided with the upper surface of the sheath or lower surface.No-station pole canopy suspender system of the present invention, pass through the design to suspender belt main body and jacket structure, improve the autologousization performance of suspender belt product, pass through the providing holes on a face of sheath, reduce the contact area of sheath and tissue, so as to substantially reduce the resistance produced when sheath takes out, convenience and operability when sheath takes out are substantially increased.
Description
Technical field
The invention belongs to implantable medical field, and in particular to a kind of no-station pole canopy suspender for being used to treat stress incontinence
System.
Background technology
Stress incontinence (Stress Urinary Incontinence, SUI):Also known as stress incontinence, is because of abdomen
Internal pressure increases, during upright or walking, due to the disease of sphincter urethrae relaxation and the nonvoluntary outflow of urine of powerless formation.Occur
It is that congenital sphincter lacks such as or function is not good mostly in teenager, aged patients are more due to damage, and production causes damage and flesh
Hypotony, gerontal patient is weak after prolonged illness in addition caused by muscular atrophy, malnutritive, and diabetes etc. may also lead to this
The generation of disease.The median age of female incontinence is 50~60 years old, and the incidence of disease is 10% ~ 40%.The urinary incontinence can often cause patient to lose
Self-respect, embarrassment are lost, the social activities and sexuality of patient is reduced, depression in patients will be caused for a long time, incontinence is also by the elderly
Deliver the most common reason of care institutions vibrations.Treatment SUI is most effective at present, most thoroughly method is to carry out no-station pole canopy sling surgery.
The principle of suspender belt treatment stress incontinence is that, based on " hammock is theoretical ", the theory thinks manadesma and anterior vaginal wall composition in pelvic cavity
One " hammock ", urethra is disposed thereon, will cause the generation of stress incontinence when hammock functional defect.After suspender belt implantation
Suspender belt main body two ends are fixed in muscle and manadesma, and play a part of support to urethra, make its anatomical position back to normal.
Existing suspender belt product is mainly what woven polypropylene was made, but such product is chronically implanted human body and deformation occurs,
The complication such as cause to corrode, expose, infect, erosion refers to that existing suspender belt is easily invaded to bladder, ureter after the implantation, and
Scope can expand gradually, and the suspender belt areal extent exposed to intracavitary can become larger, so as to cause urinary tract infection disease, repeatedly uropoiesis
It is the symptom of the corresponding sites such as infection, urinary fistula.Make patient occur vagina abnormal secretion increase, bleed, dyspareunia, pain
Deng.Further, multiple tissues are passed through because suspender belt needs to intert in implantation process, typically suspender belt easily hurts the tissue of process
And internal organs, easily cause pain or even infection;Moreover, during suspender belt is trailed in vivo, internal organs and tissue are sent out with suspender belt
Raw frictional force, easily deforms upon suspender belt and influences the mechanics of the reparation to " hammock " functional defect to adjust operation.
Fiber accumulations increases material manufacturing technology be it is a kind of by polymer solution or molten mass electricity, mechanics, optics, biology or
Polymer fiber is formed under the effect such as chemical reaction, and accumulates or deposits, the method for being configured to object in order or disorderly.Its
In, electrostatic spinning, centrifugal force spinning, hot melt spinneret, melting electrospinning, electrohydrodynamic inkjet printing(EHD jet printing)
Fiber accumulations increases material manufacturing technology is belonged to etc. technology.It is simple that fiber accumulations increases material manufacturing technology is that one kind prepares polymer fiber
And effective processing method, the tissue engineering bracket material prepared using this method, obtained in organizational project reparation extensively
Application.Its engineering rack prepared to a certain extent can effectively simulation natural extracellular matrix structure, the life to cell
Long and climbing provides good microenvironment, thus with certain biomimetic features.This current characteristic makes fiber accumulations increase material
Fiber film material prepared by manufacturing technology is particularly suitable for use in bio-medical field, such as biomembrane, drug delivery, organizational project etc.
Timbering material etc..Although inventor has had the no-station pole canopy suspender that open electrostatic spinning technique is prepared, Neng Gouke before this
The complication that some current materials are brought is taken, because the structure not to suspender belt product is deeply developed, therefore is still existed
Improved space, so that patient obtains good biocompatibility, complication is low, is easy to the safe and effective product of operation technique.
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 kind
No-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 body
With the good performance integrated with autologous tissue, and parcel suspender belt body surfaces sheath, can be to prevent by the sheath
Only cutting of the suspender belt to tissue internal organs in surgical procedure, friction during attenuating suspender belt generation activity to tissue, and be substantially reduced
The 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 table
The 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 holes
Supporting 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 out
Structure.
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 connective
Tissue, 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 into
Arc side or rounding off can be avoided stimulation of the sharp comer to tissue.Prior art is to reduce suspender belt body implant process
Resistance, being usually chosen in the surface of suspender belt main body increases a sheath.However, existing sheath is typically a complete plane
Structure, its contact surface with tissue is very big, therefore during sheath is taken out, by larger resistance.Invention human hair
Existing, 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 take
The resistance produced when going out, while can also reduce the resistance in suspender belt implantation process, substantially increases the convenience of suspender belt implant surgery
Property 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 operation
After 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, shield
Resistance 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 surface
More than the 10% of the gross area.In order to preferably reach on the resistance in reduction active procedure to tissue, preferably described sheath
The 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 sheath
Separated 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 master
Body 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 body
The 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 sheath
On 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 from
From for 0.1cm ~ 10cm.
In order to reach preferable autologousization effect, the surface of suspender belt needs to facilitate creeping for cell with certain roughness
And 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 softness
Urethra directly contact friction, when suspender belt surface roughness is larger, in daily routines, suspender belt will cause abrasion to urethra, long
The 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 thick
Rugosity is 0.1 μm~50 μm.Control can preferably meet cell and creep and grow into the range of this roughness, and reduce and hang
Abrasion 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 hole
Be 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, excellent
Selection 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 logical
The 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.Typically
Ground, 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, institute
Distribution 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 body
Density 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 postoperative
To 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 sensation
And 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 made
Position 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 operation
Operation.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.Lead
Lead 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 just
Passed through in harness system in tissue, implantation body.Preferably, described sleeve pipe entire length is 5mm ~ 20mm, more preferably
For 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 pipe
Main 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 pipe
Cone 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 guiding
One 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 pipe
Outside.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-shaped
Two parts.It is highly preferred that the length of described sleeve pipe Part I is 3mm ~ 17mm, preferably 6mm ~ 13mm.Preferably, described sleeve pipe
It 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 institute
Stating 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 less
Urethra and vagina corrode the effect of exposure probability, meanwhile, it is capable to provide certain fixed force for suspender belt.Especially for fiber accumulations
The 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 down
It 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 technology
It 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 stack
The 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 unit
Width be 1mm ~ 10mm, preferable width be 3 ~ 7mm;The spacing of two neighboring arc unit is 0mm ~ 10mm, preferably spacing
For 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 female
Property anterior vaginal wall elongation and the urinary incontinence suspention require.Preferably, elongation of the suspender belt main body when bearing 2kg gravity
For 10% ~ 50%, more preferably 15% ~ 30%, more preferably 20% ~ 25%.Within this range, the autologousization energy of suspender belt main body can be improved
Power.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 easier
Cell, 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 time
Without 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 length
For 50mm, wide 11mm batten is measured using universal tensile testing machine, and loading mode is to determine load modes, load value
It 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 laggard
Row 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 19.6N
Tensile 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 used
Into.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 method
Material, the soft tissue repair sticking patch as described in CN104645420A possesses good fluffy degree, is conducive to the fast of cell and tissue
Speed 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 drills
During 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 test
mm;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 test
The 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 fiber
Macroscopical 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 view
The 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 is
Due 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 two
The 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 0.01
μm ~ 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 bracket
Apparent thickness T3Method of testing be to be entered using FAST-1 compressibility Fabric Style instrument according to GB/T 7689.1-2001 methods
Row test, is expressed as organization bracket in 2cN/cm2Thickness (mm) and organization bracket are in 100cN/cm under pressure2It is thick under pressure
Degree(mm)Difference.Surface density ω test mode is the single face unit of measure in the case where ignoring the thickness of organization bracket
Weight under area.
Described pliability refer to according to method is tested out in GB/T 8942-2002 the counter-bending power of organization bracket and
Organization 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, CN104645420A
It 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 hangs
Autologousization performance with product, by the providing holes on a face of sheath, reduces the contact area of sheath and tissue, from
And 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 entered
Convenience 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 plant
After 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 urine
Road perienchyma, so that urethra perienchyma recovers or close to normal physiological function, no-station pole canopy suspender of the present invention
System can substantially reduce the generation of the complication such as foreign body sensation and erosion, exposure, infection.
Brief description of the drawings
Fig. 1 is a kind of structural representation of no-station pole canopy suspender system described in embodiment 1;
Fig. 2 is a kind of structural representation of no-station pole canopy suspender system described in embodiment 1;
Fig. 3 is the structural representation of the through hole set in the suspender belt main body;
Fig. 4 is the structural representation of the suspender belt body rim;
Fig. 5 is the structural representation of described sleeve pipe.
Fig. 6 is stress diagram of sheath when by traction or taking-up.
Embodiment
The no-station pole canopy suspender system of the present invention is described further with reference to some embodiments.It is specific real
Example is applied the present invention, non-limiting protection scope of the present invention is further described.
Embodiment 1
It as figure 1 shows a kind of way of realization of no-station pole canopy suspender system, including suspender belt main body 1 and cladding suspender belt main body
The sheath 2 on surface and the guide wire 4 located at suspender belt main body two ends and the sleeve pipe 3 for protecting guide wire;The suspender belt main body is set
It is equipped with the hollow out fenestral fabric being made up of multiple through holes 11, the suspender belt main body of fiber accumulations increases material manufacturing technology by being made up
Fibrous layer;The edge of the through hole is arc side or straight flange, and when the edge of the through hole is straight flange, it is round and smooth between each straight flange
Transition;The edge of the suspender belt main body is curved edge;The curved edge is made up of the arc unit 12 of multiple repeated arrangements.
The width of each arc repeat unit is 1mm ~ 10mm;The spacing of each arc repeat unit is 0mm.
It is provided with a hole 21 on the upper surface of the sheath 2 or lower surface, the shield that the area in the hole 21 is accounted for where it
Cover more than the 20% of upper surface/lower surface gross area.
Fig. 2 shows the way of realization of another no-station pole canopy suspender system, including suspender belt main body 1 and cladding suspender belt main body
The sheath 2 on surface and the guide wire 4 located at suspender belt main body two ends and the sleeve pipe 3 for protecting guide wire;The suspender belt main body is set
It is equipped with the hollow out fenestral fabric being made up of multiple through holes 11, the suspender belt main body of fiber accumulations increases material manufacturing technology by being made up
Fibrous layer;The edge of the through hole is arc side or straight flange, and when the edge of the through hole is straight flange, round and smooth mistake between each straight flange
Cross;The edge of the suspender belt main body is curved edge;The curved edge is made up of the arc unit 12 of multiple repeated arrangements.Often
The width of individual arc repeat unit is 1mm ~ 10mm;The spacing of each arc repeat unit is 0mm.
The sheath 2 is made up of symmetrical left sheath 22 and right sheath 23, and left sheath 22 and right sheath 23 are respective
It is independent;The left sheath 22 and right sheath 23, which correspond on the same face of suspender belt main body, is respectively equipped with hole 221,231.Hole 221,
The left sheath upper surface or more than the 20% of right sheath upper surface area that 231 area is accounted for where it.The left sheath 22 and right shield
There is gap in its adjacent one end in set 23, the distance in the gap is 0.1cm-10cm.The width of suspender belt main body 1 is 7 ~ 15mm.
Fig. 3 illustrates several different shapes of the through hole 11 in suspender belt main body, can be ellipse, circle or four
Angle rounding off it is square.
The curved edge 12 of suspender belt main body 1 is designed, and can be the structure of arc unit 12 by multiple repeated arrangements as described above
Into.The width of each arc repeat unit is 1mm ~ 10mm;The spacing of each arc repeat unit is 0mm;Or such as Fig. 4 institutes
Show, the presence of each arc repeat unit is less than 10mm spacing.
One end of sleeve pipe 3 is connected with suspender belt main body 1, and the other end is in cone-shaped.Preferably, the shape of described sleeve pipe 3 such as Fig. 5
Shown, sleeve pipe 3 includes the Part I 31 and the Part II in bullet-shaped in straight tube-like by being connected with suspender belt main body 1
32.The overall length of described sleeve pipe 3 is 5mm-20mm, preferably 10mm-16mm;The length of the Part I 31 is 3mm ~ 17mm, excellent
Select 6mm ~ 13mm;A diameter of 2mm ~ 8mm of Part I 31, preferably 3mm ~ 5mm.
In the present embodiment, the suspender belt main body is the tissue being made up of diameter in 0.01 μm ~ 100 μm of electrospun fibers
Support, material used can be poly- fluorine class material(PVDF, PTFE etc.), polyolefin(Polyethylene, polypropylene etc.), polyurethanes
Material(PU, PCU, TPU etc.)Etc. non-degradable material.Its fluffy degree, stability need not make extra limitation.
In order to be more convenient for, doctor is operated, it is preferable that be provided with position line on the sheath.Preferably, it is described
Line of symmetry of the position line with sheath in the axial direction is overlapped.For Fig. 1 structure, because sheath 2 is to be integrally formed, preferably in positioning
Tear line/cutting wires are set at line.
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 porous
Shape 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 test
mm;S numerical value is 1 ~ 3.Suspender belt main body described in the present embodiment may be referred to the preparation method described in CN104645420A
Prepare.
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 whole
Body)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 beef
Weight 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 belt
The 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 master
Body 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 more
It 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 process
It 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 exhibitions
Show with the stressing conditions with the sheath described in comparative example 1.State of the suspender belt in folding in tissue, the severing at C
Afterwards, 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 directions
During 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 sheath
Power, 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, when
Behind 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 sheath
When 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 notable
Reduce.Therefore the porose frictional force for being designed to eliminate suspender belt folded interior is set on a face of sheath, so as to subtract
Power 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 hair
Equivalent structure or equivalent flow conversion that bright description is made, or directly or indirectly it is used in other related technology necks
Domain, is included within the scope of the present invention.
Claims (22)
1. a kind of no-station pole canopy suspender system, it is characterised in that the no-station pole canopy suspender system includes suspender belt main body and cladding
The sheath of suspender belt body surfaces;The suspender belt main body is made up of fiber film layer, and the suspender belt main body is made up of multiple through holes
The latticed supporting structure of hollow out;Hole is provided with the upper surface of the sheath or lower surface.
2. no-station pole canopy suspender system according to claim 1, it is characterised in that the gross area in the hole on the sheath accounts for it
The sheath upper surface at place or more than the 10% of the lower surface gross area.
3. no-station pole canopy suspender system according to claim 2, it is characterised in that the gross area in the hole on the sheath accounts for it
The sheath upper surface at place or the 20% ~ 50% of the lower surface gross area.
4. no-station pole canopy suspender system according to claim 1, it is characterised in that the sheath includes being symmetrically distributed in suspender belt
Main body left side and the first sheath and the second sheath of right side;First sheath and the second sheath are respectively by suspender belt main body
Two ends extend to the center of suspender belt main body, and the first sheath and the second sheath are each independent;First sheath and the second sheath
On hole position in the same face.
5. no-station pole canopy suspender system according to claim 4, it is characterised in that located at the first sheath and/or the second sheath
On hole quantity be 1 ~ 5.
6. no-station pole canopy suspender system according to claim 4, it is characterised in that first sheath and the second sheath are at it
There is gap in adjacent one end, the distance in the gap is 0.1cm ~ 10cm.
7. the no-station pole canopy suspender system according to claim 1 to 6 any one, it is characterised in that the suspender belt main body
The roughness of upper surface and lower surface is 0.1 μm ~ 50 μm.
8. the no-station pole canopy suspender system according to claim 1 to 6 any one, it is characterised in that in the suspender belt main body
Through hole be shaped as circular, ellipse or the polygon provided with chamfering.
9. the no-station pole canopy suspender system according to claim 1 to 6 any one, it is characterised in that in the suspender belt main body
Through hole aperture be 1.5 ~ 5mm.
10. the no-station pole canopy suspender system according to claim 1 to 6 any one, it is characterised in that in the suspender belt main body
Distribution density of the through hole in suspender belt main body be 1 ~ 10/cm2。
11. no-station pole canopy suspender system according to claim 6, it is characterised in that the upper surface of the suspender belt main body and under
The roughness on surface is 0.1 μm ~ 50 μm, and being shaped as the through hole in the suspender belt main body is circular, oval or provided with chamfering
Polygon, the aperture of the through hole in the suspender belt main body is through hole in 1.5 ~ 5mm, the suspender belt main body in suspender belt main body
Distribution density be 1 ~ 10/cm2。
12. the no-station pole canopy suspender system according to claim 1 to 6 any one, it is characterised in that the suspender belt main body
Thickness is 0.1mm ~ 1mm.
13. it is provided with position line on the no-station pole canopy suspender system according to claim 1 to 6 any one, the sheath.
14. the no-station pole canopy suspender system according to claim 1 to 6 any one, it is characterised in that the no-station pole canopy suspention
Two ends with system are provided with guide wire and sleeve pipe.
15. the no-station pole canopy suspender system according to claim 14, it is characterised in that one end of described sleeve pipe and sheath and hang
Band main body connection, 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 pipe
The opening of cone shaped end extend to outside sleeve pipe.
16. no-station pole canopy suspender system according to claim 14, one end and the sheath and suspender belt main body of described sleeve pipe connect
Connect, the other end is in bullet shape;One end of the guide wire is connected with sheath and suspender belt main body, and the other end passes through the son of sleeve pipe
The opening of warhead form end is extended to outside sleeve pipe.
17. the no-station pole canopy suspender system according to claim 1 to 6 any one, the edge of the suspender belt main body is arc
Shape edge, the curved edge is made up of the arc unit of multiple repeated arrangements;The width on the arc side of each arc unit is 1mm
~ 10mm, the spacing of two neighboring arc unit is 0mm ~ 10mm.
18. the no-station pole canopy suspender system according to claim 1 to 6 any one, it is characterised in that the suspender belt main body exists
Elongation when bearing 2kg gravity is 10% ~ 50%.
19. the no-station pole canopy suspender system according to claim 1 to 6 any one, it is characterised in that the suspender belt main body
Width is 7 ~ 15mm.
20. the no-station pole canopy suspender system according to claim 14, it is characterised in that the edge of the suspender belt main body is arc
Edge, the curved edge is made up of the arc unit of multiple repeated arrangements;The width on the arc side of each arc unit for 1mm ~
10mm, the spacing of two neighboring arc unit is 0mm ~ 10mm;Elongation of the suspender belt main body when bearing 2kg gravity be
10%~50%。
21. the no-station pole canopy suspender system according to claim 1 to 6 any one, it is characterised in that 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 mm after mechanics fatigue test;S
Numerical value be 1 ~ 3.
22. the no-station pole canopy suspender system according to claim 21, it is characterised in that the fiber film layer is to be existed by diameter
The tunica fibrosa organization bracket that 0.1 μm ~ 10 μm of fiber is constituted.
Priority Applications (2)
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CN201510703366.XA CN105250050B (en) | 2015-10-26 | 2015-10-26 | A kind of no-station pole canopy suspender system |
PCT/CN2015/099217 WO2016107522A1 (en) | 2014-12-29 | 2015-12-28 | Soft tissue repair patch and preparation method thereof, and tension-free hanging belt system |
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CN201510703366.XA CN105250050B (en) | 2015-10-26 | 2015-10-26 | A kind of no-station pole canopy suspender system |
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CN105250050A CN105250050A (en) | 2016-01-20 |
CN105250050B true CN105250050B (en) | 2017-07-28 |
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US6612977B2 (en) * | 2001-01-23 | 2003-09-02 | American Medical Systems Inc. | Sling delivery system and method of use |
US7407480B2 (en) * | 2001-07-27 | 2008-08-05 | Ams Research Corporation | Method and apparatus for correction of urinary and gynecological pathologies, including treatment of incontinence cystocele |
US20090156997A1 (en) * | 2007-12-12 | 2009-06-18 | Rockford Orthopaedic Sports Medicine Services, Llc | Rotator cuff patch delivery device |
US8684908B2 (en) * | 2010-08-26 | 2014-04-01 | Ethicon, Inc. | Centering aid for implantable sling |
EP2757998A4 (en) * | 2011-09-22 | 2015-05-06 | Ams Res Corp | Pelvic implant and treatment method |
CN103800096B (en) * | 2012-11-14 | 2016-12-21 | 深圳迈普再生医学科技有限公司 | Pelvic floor dysfunction disease reparation is with implanting fiber diaphragm, preparation method and the medical apparatus and instruments containing it |
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