WO2016107522A1 - 软组织修复补片及其制备方法以及无张力悬吊带*** - Google Patents

软组织修复补片及其制备方法以及无张力悬吊带*** Download PDF

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Publication number
WO2016107522A1
WO2016107522A1 PCT/CN2015/099217 CN2015099217W WO2016107522A1 WO 2016107522 A1 WO2016107522 A1 WO 2016107522A1 CN 2015099217 W CN2015099217 W CN 2015099217W WO 2016107522 A1 WO2016107522 A1 WO 2016107522A1
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Prior art keywords
sheath
sling
tension
fiber
soft tissue
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PCT/CN2015/099217
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English (en)
French (fr)
Inventor
王国帅
赖奎霖
郭泽跃
袁玉宇
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深圳迈普再生医学科技有限公司
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Priority claimed from CN201410833554.XA external-priority patent/CN104645420B/zh
Priority claimed from CN201510703366.XA external-priority patent/CN105250050B/zh
Priority claimed from CN201520831544.2U external-priority patent/CN205234541U/zh
Application filed by 深圳迈普再生医学科技有限公司 filed Critical 深圳迈普再生医学科技有限公司
Publication of WO2016107522A1 publication Critical patent/WO2016107522A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
    • D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
    • D04H1/70—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres
    • D04H1/72—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres the fibres being randomly arranged
    • D04H1/728—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres the fibres being randomly arranged by electro-spinning
    • D—TEXTILES; PAPER
    • D06—TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06C—FINISHING, DRESSING, TENTERING OR STRETCHING TEXTILE FABRICS
    • D06C7/00—Heating or cooling textile fabrics
    • D06C7/02—Setting

Definitions

  • the invention belongs to the field of tissue engineering stents, relates to a soft tissue repair patch and a preparation method thereof, and a tensionless suspension belt system, and more particularly to a soft tissue repair patch applied to various diseases such as sputum, pelvic floor and urinary incontinence. And its preparation method and tensionless suspension belt system.
  • tissue repair membranes such as tissue repair membrane repair in hernia, repair of female pelvic floor dysfunction, repair of dural/dorsal defects, repair of nerve conduit defects, blood vessels. Repair, ligament repair, bone defect repair and other applications.
  • Woven mesh is currently the most widely used product in tissue repair, but it has a rough surface, hard texture, in vivo degradation, poor biocompatibility, foreign body sensation and pain, and common erosion and infection. Complications; and the immune rejection caused by this kind of material is strong, there are many surgical sequelae; when it is in direct contact with internal organs and organs, it is easy to cause damage, which can cause more serious adhesion, cause serious foreign body and immune reaction. Need a second surgery to remove, bring pain to the patient, and even life-threatening.
  • the fiber accumulation additive manufacturing technology is a method of forming a polymer fiber under the action of electrical, mechanical, optical, biological or chemical reaction, and depositing or depositing it in an orderly or disorderly manner, and constructing the object. method.
  • the fiber accumulation additive manufacturing technology is a simple and effective processing method for preparing polymer fibers, and the tissue engineering scaffold material prepared by the method has been widely used in tissue engineering repair.
  • the engineering scaffold prepared by the method can effectively simulate the structure of the natural extracellular matrix to a certain extent, and provides a good microenvironment for cell growth and climbing, and thus has a certain biomimetic structure. At present, this property makes the fiber membrane material prepared by the fiber accumulation additive manufacturing technology particularly suitable for the biomedical field, such as biofilm, drug delivery, tissue engineering and the like.
  • electrospinning, centrifugal spinning, hot melt spinning, melt electrospinning, EHD jet printing and other technologies are all fiber accumulation additive manufacturing technologies.
  • fiber tissue repair scaffolds prepared by fiber accumulation additive manufacturing technology can induce fibroblast growth, differentiation, collagen deposition and evolution, achieve regeneration tissue, and avoid the shortcomings of insufficient autologous scar repair strength.
  • Practice has also found that by controlling the bulkiness of the fiber scaffold to control the growth of the cells In this case, if the fiber fluff is increased, more cells can grow in, induce self-organization to achieve defect repair faster, and bring better mechanical support and functional recovery to the defect soft tissue.
  • the inventors have disclosed a patch having a certain degree of bulkiness, and further, the softness of the patch can be adjusted to obtain a patch with better performance.
  • the inventors found that in addition to the factors of bulkiness and softness, the pore size and porosity of the stent are maintained for a long period of time, and the cell formation in the stent is induced in the long-term environment of the stent material, and stability is provided. Structural support or functional assistance plays a crucial role.
  • repair stents Especially for soft tissue scaffolds used to repair various types of warts, pelvic floor, urinary incontinence and other diseases, because such soft tissues often have to undergo certain stress changes, such as clinical patients with cough, constipation and other causes of abdominal pressure rise, repair stents
  • the material will withstand a certain tensile stress. After long-term stress stretching, the pore size and porosity of the stent change, so it is more important to maintain the pore size and porosity of the stent.
  • changes in the pore size and porosity of the scaffold will cause the scaffold material repair effect to deviate from expectations.
  • the patch has better bulkiness and softness, its long-term stability is poor, it is prone to deformation, and it is prone to cell growth too fast, resulting in new problems such as hyperplasia. . Therefore, it is very meaningful to prepare a scaffold material which has good bulkiness and softness, and maintains a stable pore size and porosity during long-term fusion and evolution in the body, and maintains cell growth and differentiation at a reasonable level.
  • Urinary Incontinence also known as tension urinary incontinence
  • tension urinary incontinence is a common form of pelvic floor dysfunction in women. It is mainly caused by urinary sphincter relaxation and inability to form urine when the intra-abdominal pressure is increased. Feel free to flow out. Urinary incontinence often leads to loss of self-esteem and paralysis, and reduces the social activities and sexual activities of patients. It will lead to depression in the long term, and incontinence is also the most common reason for sending elderly people to nursing institutions.
  • the most effective and thorough method for treating SUI is to perform tension-free sling surgery, which plays a supporting role for the urethra and restores its anatomical position to normal.
  • the existing sling products are mainly made of woven polypropylene, but these products will be deformed in the human body for a long time, leading to complications such as erosion, exposure and infection. Erosion means that the existing slings are easy to the bladder after implantation.
  • the ureter is invaded, and the range will gradually expand.
  • the area of the sling exposed to the cavity will gradually become larger, causing symptoms such as urinary tract irritation, repeated urinary tract infection, and urinary fistula.
  • the patient has increased vaginal abnormal secretions, bleeding, difficulty in sexual intercourse, and pain.
  • the sling needs to be inserted through a plurality of tissues during the implantation process, the sling is often easily cut. Tissues and organs are prone to pain and even infection; moreover, the friction between the organ and the sling during the traction of the sling is easy to deform the sling and affect the mechanics of repairing the functional defects of the "hammock" Adjust the operation.
  • tension-free suspension straps increase the difficulty of surgery when implanted in the human body, or uncontrollable deformation due to pulling during implantation, which brings uncontrollable risks to clinical use and affects the final therapeutic effect. . Therefore, reducing the resistance of the sling during the implantation process and protecting the sling throughout the process, avoiding the deformation caused by the pulling is particularly important for effective treatment of the SUI.
  • the sheath is covered on the main body of the sling, but the existing sheath is usually a complete planar structure, and the contact surface with the human tissue is large, and when the sling passes through the tissue, curling occurs. The portion of the sheath that is entangled inside has a large pressing force, so that a large resistance is generated in the process of taking out the sheath, and sometimes the sheath is broken.
  • the object of the present invention is to overcome the deficiencies in the prior art and provide a patch suitable for soft tissue repair, which has good bulkiness, is favorable for rapid adhesion and proliferation of cells and tissues, and guides cell differentiation, and is beneficial to The close fit between the tissues, while maintaining pore size and porosity stability during long-term in vivo fusion and evolution.
  • Another object of the present invention is to provide a method for preparing the above-described patch suitable for soft tissue repair.
  • Another object of the present invention is to provide a tensionless suspension belt system.
  • the present invention adopts the following technical solutions:
  • a soft tissue repair patch wherein the soft tissue repair patch is a tissue scaffold composed of fibers having a diameter of 0.01 ⁇ m to 10 ⁇ m, has a porous structure, and has a bulkiness of 200-2000 cm 3 /g, and fusion occurs at the fiber junction.
  • the stability S of the tissue scaffold meets the following relationship:
  • T 1 is the initial thickness of the tissue scaffold
  • T 2 is the thickness of the tissue scaffold measured after the mechanical fatigue test, and the thickness is in mm
  • the value of S is 1-3.
  • a soft tissue repair sheet which satisfies the above relationship by forming a stable connection between adjacent electrospun fibers not only has a good bulkiness, but also facilitates rapid adhesion and proliferation of cells and tissues, and guides cell differentiation. Conducive to the close fit between the tissues, while maintaining the stability of pore size and porosity during long-term in vivo fusion and evolution.
  • Stability refers to the ratio of the initial thickness of the tissue scaffold to the thickness of the tissue scaffold measured after the mechanical fatigue test.
  • the test method of each parameter refers to the following method:
  • the test method for the initial thickness of the tissue scaffold is tested by the FAST-1 compressive fabric style instrument according to the method of GB/T 7689.1-2001, indicating the thickness of the tissue scaffold under a pressure of 2 cN/cm 2 ;
  • the mechanical fatigue test is based on the requirement of the soft tissue repair patch at different positions in the body, and is stretched 1000 to 4000000 times in a tensile strength of 2 to 50 MPa.
  • the mechanical fatigue test is the mechanical fatigue test, and the tensile strength is 10,000 times in a tensile strength of 10 MPa.
  • the value of S is 1-2.
  • the tensile strength and number of stretching of the mechanical fatigue test can be selected by those skilled in the art according to the requirements of the soft tissue repair patch at different positions in the body. These requirements can be found in the clinician's anatomical literature.
  • the soft tissue repair patch has a thickness of 0.15 to 2 mm.
  • the fiber junctions are fused to form a fiber node which is a microscopic node formed by fusion at the intersection between the fibers or a macroscopic node formed by fusion at the side-by-side contact between the fibers.
  • the microscopic nodes have a shape of agglomerates and an average diameter of 10 nm to 10 ⁇ m.
  • the macroscopic node has a linear shape and a cluster shape, and the linear macro node has a line width of 25 to 1000 ⁇ m; the agglomerate macro node has an average diameter of 25 to 1000 ⁇ m.
  • the agglomerate shape includes a spherical shape with a regular surface or an irregular spherical shape; The shape is formed by agglomeration after the fibers are melted.
  • the line macroscopic node has a line width of 50 to 500 ⁇ m; the agglomerate macro node has a diameter of 50 to 500 ⁇ m.
  • the spacing of any two of the macro nodes is between 100 and 5000 ⁇ m. More preferably, the pitch of any two of the macro nodes is 100 to 1000 ⁇ m.
  • the soft tissue repair patch has a bulkiness of 200 to 2000 cm 3 /g.
  • the soft tissue repair patch has a softness of 50 to 500 millinewtons.
  • the soft tissue repair patch has a softness of 200 to 450 millinewtons.
  • the bulkiness and softness of the present invention can be referred to CN103800096A, that is, the bulkiness of the present invention refers to 1000 times the ratio of the apparent thickness to the areal density of the tissue scaffold composed of fibers of 0.01 ⁇ m to 10 ⁇ m, that is,
  • the bulkiness is expressed in cm 3 /g
  • the apparent thickness is expressed in mm
  • the areal density is expressed in g/m 2 .
  • the test method for the apparent thickness T 3 of the tissue scaffold is tested by the FAST-1 compressive fabric style instrument according to the method of GB/T7689.1-2001, which is expressed as the thickness (mm) and tissue of the tissue scaffold under the pressure of 2cN/cm 2 .
  • the areal density ⁇ is measured by measuring the weight of a single face unit area without ignoring the thickness of the tissue scaffold.
  • the softness according to the present invention refers to the sum of the bending resistance of the tissue scaffold and the maximum vector of the friction between the tissue scaffold and the slit, which is tested according to the method of GB/T 8942-2002, expressed in millinewtons, and the softness value is smaller.
  • the softness value is smaller.
  • the material constituting the fiber is a polyurethane, polyester or fluorine-based material, more specifically, L-polylactic acid (PLLA), polyvinylidene fluoride (PVDF), polycaprolactone (PCL). ) and polyurethane.
  • PLLA L-polylactic acid
  • PVDF polyvinylidene fluoride
  • PCL polycaprolactone
  • the soft tissue repair patch can be made from a fiber accumulation additive manufacturing technique, and then the fiber membrane is treated to fuse the fiber junction to form a fiber node.
  • the soft tissue repair patch is obtained by an electrospinning technique, and then the fiber membrane is treated to fuse the fiber junction to form a fiber node.
  • the method includes the following steps:
  • the solvent is composed of solvent A and solvent B, and the volume ratio of solvent A to solvent B is 1:9 to 9:1; solvent A The boiling point is higher than 80 ° C, the boiling point of solvent B is lower than 60 ° C;
  • step S2 The fiber material solution obtained in step S1. is charged into an electrospinning syringe, electrospun to obtain a fiber filament, and the fiber filament is received into a film-like structure to obtain a fiber membrane;
  • the fiber membrane obtained in step S2 is hot-dried or cold-pressed and then dried to obtain the soft tissue repair patch; the pressure of the hot or cold pressure ranges from 10 3 Pa to 10 6 Pa; The pressure temperature ranges from 50 ° C to 300 ° C; the cold press temperature is room temperature. Preferably, the hot pressing temperature is preferably in the range of 70 ° C to 200 ° C.
  • the difference between the boiling temperatures of solvent A and solvent B is greater than 30 °C.
  • the preparation method of the above soft tissue repair patch includes the following steps:
  • step S2 The fiber material solution obtained in step S1 is charged into an electrospinning syringe, electrospun to obtain a fiber filament, and the fiber filament is received into a film-like structure to obtain a fiber membrane;
  • the fibrous film is subjected to hot pressing between a range of 80 ° C to a temperature of Tm below the Tm of the material having a lower melting point to obtain the soft tissue repair patch.
  • Tm is the melting temperature of the material.
  • the fiber filaments In the step S2 of the above Option 1 and Option 2, it is preferred to orient the fiber filaments first, and then carry out the remaining steps.
  • the orientation orientation can further reduce the angle between the different fibers and the lateral component of the force, and reduce the influence of the force on the fiber nodes, so as to enhance the long-term stability of the stent material in the human body.
  • one fiber In the disorderly arrangement of electrospun fibers, one fiber is in a state of bending and winding, which can exhibit large deformation characteristics; after the cells grow into the electrospun stent, the fibers in the bent state are easily stretched by the elongated cells, resulting in the material of the stent. Deformation affects the postoperative recovery effect.
  • the method comprises the steps of: preparing an electrospun fiber membrane according to a conventional method, heating the fiber material with a laser of 0.1w to 10w power, and scanning the laser head at a speed of 0.1-1000 mm/s, the laser beam width For 25 to 1000 ⁇ m, a grating pattern having a stripe pitch of 50 to 5000 mm is scanned on the surface of the film by using a laser beam to partially melt the fiber material without vaporization, and the soft tissue repair patch is obtained.
  • the method comprises the steps of: preparing an electrospun fiber membrane according to a conventional method, using a welded head member having a tip diameter of 25 to 1000 ⁇ m and a longitudinal and lateral spacing of the needle array of 50 to 5000 ⁇ m;
  • the electrospun film is polymer welded to partially melt the fiber; the soldering temperature is 50 ° C to 300 ° C.
  • a welded head member having a tip diameter of 25 to 100 ⁇ m and a longitudinal and lateral pitch of the needle array of 500 to 3000 ⁇ m to perform polymer welding on the electrospun film.
  • the conventional method includes the steps of preparing an electrospinning solution, spinning, and receiving a film formation, and the process conditions can be referred to the existing electrospinning fiber membrane preparation process conditions.
  • the polymer welding method may be heat welding, ultrasonic welding or electric resistance welding; the welding temperature is selected according to the properties of the material.
  • the stretching operation is performed.
  • the stretching operation controls the porosity of the node strengthening material.
  • the application of the soft tissue repair patch according to the present invention may be prepared into different products according to needs, such as common types of sputum patches, pelvic floor patches or tension-free suspension straps.
  • the invention provides a tension-free suspension belt system
  • the tension-free suspension belt system comprises a sling main body and a sheath covering the surface of the sling main body;
  • the sling main body is composed of a fiber membrane layer, and the sling main body is composed of a plurality of slings
  • a hollow mesh-like stent structure composed of holes; a hole is provided on the upper surface or the lower surface of the sheath.
  • the sling body is composed of a fibrous film layer having a biomimetic structure.
  • the method for preparing the fibrous film layer having the biomimetic structure can be produced by an existing preparation method.
  • the fibrous film layer having a biomimetic structure is produced by a fiber packing additive manufacturing technique.
  • the fibrous film layer is produced by an electrospinning technique.
  • the biomimetic structure refers to a structure that mimics a natural extracellular matrix.
  • the through hole on the main body of the sling can be obtained by laser engraving, stamping, partial pressure melting, mechanical cutting or the like. Since the main body of the sling has a plurality of through holes, the arrangement thereof is similar to a grid shape, and thus the sling main body has a hollow mesh-like support structure.
  • the hollow mesh-like stent structure on the main body of the sling is beneficial for inducing autologous cell growth, forming connective tissue, strengthening the surrounding tissue of the urethra, and the sling main body has optimized strength and elasticity, and the edge of the through hole is designed to be curved or smooth. The transition avoids the stimulation of tissue by sharp angles.
  • a sheath to the surface of the sling body.
  • the existing sheath is usually a complete planar structure, and its contact surface with human tissue is large, so that a large resistance is obtained during the removal of the sheath.
  • the inventors have found that providing a hole in one side of the sheath can reduce the contact area of the sheath with the human tissue, and can significantly reduce the resistance generated when the sheath is taken out, and also It can reduce the resistance during the sling implantation process, greatly improving the convenience and operability of the sling implantation.
  • the movement of the sling in the human body mainly includes the pulling of the sling during the operation, and after the operation is completed, the sheath is separated from the main body of the sling.
  • the area of the hole in the sheath is inversely proportional to the change in resistance produced when the sheath is removed.
  • the total area of the holes in the sheath is more than 10% of the total area of the upper or lower surface of the sheath on which it is placed. In order to better achieve the reduction of resistance to human tissue during the activity, it is preferred that the total area of the holes in the sheath accounts for 20% to 50% of the total area of the upper or lower surface of the sheath.
  • the sheath may be an integrally formed sheath or may be composed of two sub-sheaths. In order to better separate the sheath from the sling body, it is preferred to use the form of a sub-sheath.
  • the sheath comprises a first sheath and a second sheath symmetrically distributed in the left and right halves of the sling body; the first and second sheaths are respectively The end extends toward the center of the sling body, and the first sheath and the second sheath are each independent; the upper holes of the first sheath and the second sheath are located on the same side.
  • the number of holes in the sheath can be one or more.
  • the number of holes provided on the first sheath and/or the second sheath is 1 to 5.
  • the first sheath and the second sheath have a gap at an adjacent end thereof.
  • the gap is from 0.1 cm to 10 cm.
  • the surface of the sling needs to have a certain roughness to facilitate cell creep and growth; on the other hand, because the sling implantation position is the urethra and vaginal anterior wall space, daily activities will lead to sling and softness.
  • the urethra is in direct contact with the friction.
  • the surface roughness of the sling is large, the sling will cause wear on the urethra during daily activities, and prolonged wear may cause urethral erosion.
  • the upper surface and the lower surface of the sling main body have a roughness of 0.1 ⁇ m to 50 ⁇ m. Control within this range of roughness, better to meet cell creeping and reduce the wear of the sling on the urethra.
  • the shape of the through hole on the body of the sling may be a regular shape or an irregular shape.
  • the through hole has a circular shape, an elliptical shape or a chamfered polygon.
  • the through hole has a diameter of 1.5 to 5 mm. More preferably, the through hole has a pore diameter of 3 to 4.5 mm. More preferably, the through hole has a pore diameter of 4 mm.
  • the distribution density of the through holes on the main body of the sling has a certain influence on the mechanical properties of the tension-free suspension belt. In general, if the amount of opening in the main body of the sling is too large, the mechanical properties of the tension-free suspension belt are significantly lowered.
  • the through holes have a distribution density of 1 to 10/cm 2 on the sling body. More preferably, the through holes have a distribution density of 2 to 8 / cm 2 on the sling body. More preferably, the through holes have a distribution density of 3 to 6 / cm 2 on the sling body.
  • the sling body has a thickness of 0.1 mm to 1 mm.
  • the thickness of the main body of the sling is 0.2-0.25 mm; since the sling implantation position is the anterior wall of the vagina, for a sexually active user, a thick sling will make it feel foreign body sensation and tingling; when the thickness of the sling is lowered At 0.25 mm or less, the patient's foreign body sensation will be significantly reduced.
  • the sheath is provided with a positioning line.
  • the positioning line can be used as a sheath cutting positioning line.
  • the cutting positioning line and the sheath are in the axial direction of the sling main body.
  • the symmetry lines coincide.
  • the tensionless suspension strap system is provided with guide wires at both ends.
  • the design of the lead wire makes it easier to operate.
  • the connecting line of the guiding line and the main body of the sling is provided with a sleeve for protecting the guiding line and facilitating puncture.
  • the connection between the lead wire and the main body of the sling is exposed and easily damaged, and the addition of the sleeve can improve the life of the joint.
  • the sleeve has an overall length of 5 mm to 20 mm, more preferably 10 mm to 16 mm; and the sleeve diameter is 2 mm to 8 mm, preferably 3 mm to 5 mm.
  • the tension-free suspension belt system is provided with guiding wires and sleeves at both ends thereof, one end of the sleeve is connected with the sheath and the main body of the sling, and the other end is tapered; the one end of the guiding line and the sheath and The sling body is connected and the other end extends through the tapered end opening of the sleeve to the outside of the sleeve.
  • Conical sleeves reduce the resistance to the puncture process.
  • one end of the sleeve is connected to the sheath and the sling body, and the other end is in the shape of a bullet.
  • One end of the guide wire is connected to the sheath and the sling body, and the other end extends through the bullet-shaped end opening of the sleeve to the outside of the sleeve.
  • the sleeve includes a first portion that is straight tubularly connected to the sheath and the sling body and a second portion that is bullet-shaped. More preferably, the first portion of the sleeve has a length of from 3 mm to 17 mm, preferably from 6 mm to 13 mm.
  • the sleeve is composed of a polyperfluoroethylene propylene copolymer having high smooth surface properties. A cannula prepared using the above shapes and materials can reduce damage to tissues and blood vessels during puncture.
  • the sheath has a smooth surface, and the material of the sheath is preferably polyethylene or polypropylene.
  • the edge of the main body of the sling is designed with a curved edge, which can reduce the cutting stimulation of the tissue at the edge of the sling, and has the effect of reducing the exposure of the urethra and vaginal erosion, and at the same time, can provide a certain fixing force for the sling.
  • the surface of the sling main body made by the fiber accumulation additive manufacturing technology is relatively flat, and there is no burr or barb on the surface of the main body of the woven woven fabric, so the fiber accumulation additive
  • the fixing force of the sling body and the tissue made by the manufacturing technique is generally low.
  • the curved edge is composed of a plurality of repeatedly arranged curved cells.
  • each of the curved units has a width of 1 mm to 10 mm, preferably a width of 3 to 7 mm; and a spacing between adjacent two curved units is 0 mm to 10 mm, and preferably a pitch of 3 to 7 mm.
  • the mechanical performance requirements of the main body of the sling can refer to the mechanical properties of the existing sling products, or refer to the elongation of the anterior wall of the normal woman's vagina and the urinary incontinence suspension requirements.
  • the sling body has an elongation of from 10% to 50%, more preferably from 15% to 30%, more preferably from 20% to 25%, when subjected to 2 kg of gravity. Within this range, the self-assembly ability of the sling body can be improved.
  • the self-assembly ability of the sling body is a reflection of the sling repair effect.
  • the substance affects biocompatibility and has good anti-infective ability.
  • the method for measuring the elongation of the sling main body when subjected to 2 kg of gravity is: cutting the main body of the sling into a length of 50 mm and a width of 11 mm, and measuring by a universal tensile testing machine, the loading mode is a constant load mode, and the load value is Set to 19.6N, then clamp the ends of the main body of the sling with the clamp of the tensile testing machine. After the zero test, the tensile tester performs the tensile test.
  • the tensile condition is: the stretching speed is 50mm per minute, and the clamp spacing is 40mm. The tensile elongation of the sling body at 19.6 N tensile force was recorded.
  • the sling body has a width of 7 to 15 mm.
  • the sling body has a width of 9 mm to 11 mm.
  • the sheath comprises a cavity formed by the sheath body and the sheath body, and one end of the sheath body is provided with a cavity opening, and the other end is provided with a folded portion, and the upper surface of the sheath body is provided with the hole The folded portion is folded upward.
  • the hole is contracted from the central portion to the opening of the cavity and forms a maximum point of force of the hole, and a cutting line extending to the opening of the cavity is provided at the point of maximum force.
  • the sheath Since the sheath is usually pulled out from the end of the traction sheath away from the opening of the cavity during use, the maximum force point on the hole is prone to irregular tearing during the extraction process, and the tear is prone to fragmentation. Remains in the human body. By increasing the cutting line, when the sheath is taken out, the sheath will undergo a relatively regular break along the cutting line, avoiding the above-mentioned adverse effects.
  • the sheath may be configured to include a sheath body and a cavity for accommodating the sling body, the sheath body being provided with the hole, the edge of the hole being close to the cavity opening a direction away from the cavity opening direction is a front portion, a middle portion, and a last portion connected in sequence;
  • the front portion includes a first front edge line and a second front edge line, and a junction formed by the intersection of the two lines, The junction is the maximum force point, and the distance from the junction to the edge of the cavity opening is smaller than the distance from the first front edge line and any other point on the second front edge line to the opening edge of the cavity
  • the junction is provided with a cutting line extending to the opening of the cavity.
  • the cutting line is coplanar with the axis of the sheath body.
  • the direction of the fracture of the sheath is the same as the direction of the force when the sheath is taken out, and the force is more uniform, reducing the resistance.
  • the first front edge line and the second front edge line are symmetrical planes with a plane common to the cutting line and the axis line of the sheath body.
  • the depth of the cutting line accounts for 30 to 90% of the thickness of the sheath body in which it is placed, and further, it occupies 50% of the thickness of the sheath body.
  • the edge lines of the front portion, the middle portion, and the end portion may be line segments of any shape, provided that the above conditions are satisfied.
  • the middle portion includes a first middle edge line connected to the first front edge line and a second middle edge line connected to the second front edge line.
  • first middle edge line and the second middle edge line are in the cutting line and the sheath body
  • the plane common to the axis lines is a plane of symmetry.
  • the sheath body has a width of 10 to 15 mm, and more preferably, a distance between the first middle edge line and the second middle edge line is 6 to 11 mm.
  • the fold includes a first fold, a second fold, an extension, and a fold where the three meet.
  • the edge line of the end of the hole has a distance of 2 to 6 cm from the fold.
  • the extending direction of each of the hole extending sheaths is neatly arranged.
  • the distance from the edge line of the end of the hole closest to the folded portion to the folded portion is 2 to 6 cm. More preferably, there is a cutting line between adjacent holes. More preferably, the cutting line is coplanar with the axis of the sheath body.
  • the sheath has a smooth surface, and the material of the sheath is preferably polyethylene or polytetrafluoroethylene.
  • the fibrous film layer may be made of any material as long as the fibrous film layer made of these materials has the function described. Preferably, it is made using a conventional non-degradable material.
  • the non-degradable materials mainly include non-degradable materials such as polyfluorinated materials (PVDF, PTFE, etc.), polyolefins (polyethylene, polypropylene, etc.), and polyurethane-based materials (PU, PCU, TPU, etc.).
  • the non-degradable material is processed into a material having a certain degree of bulkiness and stability, such as processing into the soft tissue repair patch, having a good bulkiness, and facilitating rapid adhesion and proliferation of cells and tissues.
  • a material having a certain degree of bulkiness and stability such as processing into the soft tissue repair patch, having a good bulkiness, and facilitating rapid adhesion and proliferation of cells and tissues.
  • Guide cell differentiation which is conducive to the close fit between tissues, while maintaining pore size and porosity stability during long-term in vivo fusion and evolution.
  • the fiber membrane layer is a fibrous membrane tissue scaffold composed of fibers having a diameter of 0.01 ⁇ m to 100 ⁇ m, and has a porous structure with a bulkiness of 200-2000 cm 3 /g, and the fiber intersection is fused to form a fiber node. ;
  • the stability S of the tissue scaffold meets the following relationship:
  • T 1 is the initial thickness of the tissue scaffold
  • T 2 is the thickness of the tissue scaffold measured after the mechanical fatigue test, and the thickness is in mm
  • the value of S is 1-3.
  • the fibrous membrane layer is a fibrous membrane tissue scaffold composed of fibers having a diameter of 0.1 ⁇ m to 10 ⁇ m. Therefore, preferably, the fibrous membrane layer is the above soft tissue repair patch, which can be prepared by the above-described method for preparing a soft tissue repair patch.
  • the present invention has the following beneficial effects:
  • the soft tissue repair patch provided by the invention can meet different pore diameters and pores required by different cells in the human body; strengthens the bonding force between the fibers and optimizes the fiber orientation arrangement, so that the fiber stent is stably formed. Pore structure; The soft tissue repair patch provided by the present invention maintains pore, pore and shape stability during cell growth and long-term evolution.
  • the soft tissue repair patch of the invention has better cell growth characteristics, and achieves the purpose of merging the implanted patch with the self tissue by proliferating macrophages and inducing new capillary formation.
  • the soft tissue repair patch provides stable structural support or functional assistance in a long-term in vivo environment and thus can be used as a tissue repair product with better cell growth and a more stable structure during long-term evolution in the human body.
  • the tension-free suspension belt system of the invention improves the self-sizing performance of the sling product by designing the sling main body and the sheath structure, and reduces the contact between the sheath and the human tissue by providing holes on one side of the sheath.
  • the area which significantly reduces the resistance generated by the sheathed sling during movement in the human body, greatly improving the convenience and operability of the sheath when taking out or pulling the sling.
  • the sling is less irritating to human tissue during implantation in the human body.
  • the tension-free suspension system of the present invention can significantly reduce the occurrence of foreign body sensation and complications such as erosion, exposure and infection, as the surrounding tissue recovers or approaches normal physiological functions. Further, by providing the cutting line on the sheath, when the sheath is taken out and subjected to a large pressure, the sheath can be easily broken along the cutting line to form a regular crack, which can further reduce tearing when the sheath is taken out. Cracking creates the risk of debris remaining in the body, facilitating surgical procedures and improving surgical safety.
  • Figure 1 is a view showing the biocompatibility and growth of fresh tissue of the patch of Example 7;
  • Figure 2 is the biocompatibility of the control patch and the growth of new tissue
  • Figure 3 is the biocompatibility of the control patch and the growth of new tissue
  • Figure 4 is a scanning electron micrograph of the patch prepared in Example 1, in which the white ring is a dough-like microscopic node formed by cross-over bonding between fibers;
  • Figure 5 is a scanning electron micrograph of the patch prepared in Example 1, in which the white ring is a relatively strong cluster-like microscopic node formed between the intersecting fibers;
  • Figure 6 is a scanning electron micrograph of the patch of Comparative Example 1;
  • Figure 7 is a scanning electron micrograph of the patch of Example 6;
  • Figure 8 is a diagram showing a node of a patch prepared in Example 7.
  • FIG. 9 is a detailed view of the dough nodes of the patch prepared in Example 7.
  • Figure 10 is a microscopic weld morphology of agglomerated node fibers of the patch prepared in Example 7;
  • Figure 11 is a line node diagram of the patch prepared in Example 7.
  • Figure 12 is a scanning electron micrograph of a node of the patch prepared in Example 8.
  • Figure 13 is a scanning electron micrograph of the node of the patch prepared in Example 8.
  • FIG. 14 is a schematic structural view of a tensionless suspension belt system according to Embodiment 9;
  • FIG. 15 is a schematic structural view of a tensionless suspension belt system according to Embodiment 9;
  • FIG. 16 is a schematic structural view of a through hole provided in the main body of the sling according to Embodiment 9;
  • Figure 17 is a schematic structural view of the edge of the main body of the sling according to the embodiment 9;
  • Figure 18 is a schematic view showing the structure of the sleeve of the embodiment 9.
  • Figure 19 is a schematic view of the force of the sheath as it is towed or removed.
  • Figure 20 is a schematic view showing the structure of the sheath of the eleventh embodiment.
  • Figure 21 is a schematic view showing the structure of the sheath of Example 12.
  • Figure 22 is a partial schematic view showing the sheath body and the cutting line of the embodiment 12.
  • Figure 23 is a side view of the sheath body of the embodiment 12 (the cavity opening direction).
  • Figure 24 is a schematic view showing the structure of the sheath of the embodiment 13.
  • Figure 25 is a schematic view showing the structure of the sheath of Example 14.
  • the mechanical fatigue performance test is tested according to the requirements of the patch applied to the sling.
  • the specific conditions are the dynamic fatigue test using the BOSE ElectroForce (ELF) test machine.
  • the test conditions are as follows:
  • Preparation sample size 50mm ⁇ 10mm ⁇ 0.5mm (length ⁇ width ⁇ thickness);
  • Fatigue loading times 500000 times
  • L-polylactic acid (PLLA) is dissolved in a volume ratio of 4:6 dichloromethane / 1,4 dioxane mixed solvent, the concentration of PLLA in the solution is 6g / 100mL;
  • the fiber material solution obtained in the step (1) is charged into the electrospinning syringe, the rate of the micro syringe pump is adjusted to 2 ml/h, the voltage of the high voltage generator is adjusted to 15 kV, and the receiving distance of the receiving device is adjusted. 15 cm, electrospinning was carried out to obtain fibers, and the fibers were received into a film-like structure. After spinning to a thickness of about 0.5 mm, the electrospinning was turned off to obtain a fiber membrane.
  • the above fiber membrane was subjected to a molding machine at a set temperature of room temperature, a pressure of 0.1 MPa, and a pressurization time of 20 s. After cold pressing, it was placed in a blast drying oven at a temperature of 45 °C. After drying for 12 hours, it was taken out to obtain a degradable tissue repair film with moderate fiber node strength.
  • PVDF polyvinylidene fluoride
  • the fiber material solution obtained in the step (1) is charged into the electrospinning syringe, the rate of the micro syringe pump is adjusted to 4 ml/h, the voltage of the high voltage generator is adjusted to 30 kV, and the receiving distance of the receiving device is adjusted. At 25 cm, electrospinning was carried out to obtain fibers, and the fibers were received into a film-like structure. After spinning to a thickness of about 0.5 mm, the electrospinning was turned off to obtain a fiber membrane.
  • the above fiber membrane was subjected to a molding machine at a set temperature of 60 ° C, a pressure of 0.4 MPa, and a heating time of 20 s. After hot pressing, it was placed in a blast drying oven at a temperature of 60 °C. After drying for 12 hours, it was taken out to obtain a non-degradable tissue repair film with high fiber node strength.
  • PVDF polyvinylidene fluoride
  • the fiber material solution obtained in the step (1) is charged into the electrospinning syringe, the rate of the micro syringe pump is adjusted to 4 ml/h, the voltage of the high voltage generator is adjusted to 30 kV, and the receiving device is adjusted.
  • the distance was 25 cm, electrospinning was carried out to obtain fibers, and the fibers were received into a film-like structure. After the thickness of the film layer was about 0.5 mm, the electrospinning was turned off to obtain a fiber film.
  • the above fiber membrane was subjected to a molding machine at a set temperature of 70 ° C, a pressure of 0.8 MPa, and a heating time of 20 s. After hot pressing, it was placed in a blast drying oven at a temperature of 60 °C. After drying for 12 hours, it was taken out to obtain a non-degradable tissue repair film with higher fiber node strength.
  • PVDF polyvinylidene fluoride
  • the fiber material solution obtained in the step (1) is charged into the electrospinning syringe, the rate of the micro syringe pump is adjusted to 4 ml/h, the voltage of the high voltage generator is adjusted to 30 kV, and the receiving distance of the receiving device is adjusted. 25cm.
  • the receiving device orients the fibers by applying an electric field, a grid-type receptor, and a high rotation speed to obtain a fiber film having a relatively finely twisted fiber and a fiber-oriented arrangement.
  • Electrospinning was carried out to obtain fibers, and the fibers were received into a film-like structure. After spinning to a thickness of about 0.5 mm, the electrospinning was turned off to obtain a fiber membrane.
  • the above fiber membrane was subjected to a molding machine at a set temperature of 60 ° C, a pressure of 0.2 MPa, and a heating time of 20 s. After hot pressing, it was placed in a blast drying oven at a temperature of 60 °C. After drying for 12 hours, it was taken out to obtain a non-degradable tissue repair film with high fiber node strength, and the film can further improve the stability of long-term evolution after implantation.
  • PVDF polyvinylidene fluoride
  • the fiber material solution obtained in the step (1) is charged into the electrospinning syringe, the rate of the micro syringe pump is adjusted to 4 ml/h, the voltage of the high voltage generator is adjusted to 30 kV, and the receiving distance of the receiving device is adjusted. At 25 cm, electrospinning was carried out to obtain fibers, and the fibers were subjected to a film-like structure. After spinning to a thickness of about 0.5 mm, the electrospinning was turned off to obtain a fiber membrane.
  • the above-mentioned dried fiber membrane is placed in a laser cutting machine. After focusing, set the laser power to 1W, the laser head scanning speed to 1000mm/s, and the laser beam width to 50 ⁇ m. A grating pattern having a stripe pitch of 1 mm was scanned on the surface of the film using a laser beam. A non-degradable tissue repair film that further strengthens the fiber node strength of the film surface is obtained.
  • PVDF polyvinylidene fluoride
  • the fiber material solution obtained in the step (1) is charged into the electrospinning syringe, the rate of the micro syringe pump is adjusted to 4 ml/h, the voltage of the high voltage generator is adjusted to 30 kV, and the receiving distance of the receiving device is adjusted. At 25 cm, electrospinning was carried out to obtain fibers, and the fibers were subjected to a film-like structure. After spinning to a thickness of about 0.5 mm, the electrospinning was turned off to obtain a fiber membrane.
  • the above-mentioned dried fiber membrane is placed in an ultrasonic welding machine.
  • the fiber membrane was ultrasonically welded using a welded head member having a tip diameter of 100 ⁇ m and a longitudinal and lateral spacing of the needle array of 3 mm to obtain a tissue repair membrane having a high fiber node strength.
  • PVDF polyvinylidene fluoride
  • the fiber material solution obtained in the step (1) is charged into the electrospinning syringe, the rate of the micro syringe pump is adjusted to 4 ml/h, the voltage of the high voltage generator is adjusted to 30 kV, and the receiving distance of the receiving device is adjusted. At 25 cm, electrospinning was carried out to obtain fibers, and the fibers were subjected to a film-like structure. After spinning to a thickness of about 0.5 mm, the electrospinning was turned off to obtain a fiber membrane.
  • the experimental animals were selected from New Zealand rabbits weighing 2.2 kg, aged 6-12 months, for a total of 27.
  • the experimental rabbits were randomly divided into 9 groups, 3 experimental animals in each group, and subcutaneously implanted in rabbits at the 3 month observation period.
  • the materials of the experimental group were selected from the membranes of Examples 1 to 8, and the control group was the membrane of Comparative Example 1, and the materials were cut to have a length and width of 1 ⁇ 4 cm.
  • the subcutaneous muscle layers of the rabbit's abdomen were implanted separately, and the tissue growth of the material was observed 3 months after surgery.
  • Implantation method remove the rabbit's abdomen coat, disinfect, scalpel gently cut the skin, do not cut the muscles, use the non-toothed tendon to gently lift the fascia next to the midline of the abdomen, and use the scalpel to cut the fascia along the midline of the abdomen Without damaging the muscles, the scalpel handle bluntly separates the subcutaneous fascia from the muscle, exposing a suitable range of material implantation. For all experimental animals, samples were implanted between the subcutaneous fascia and the muscle layer, and the material was fixed in the corresponding position with a wire 4, and sutured.
  • Figure 14 shows an implementation of a tension-free suspension strap system comprising a sling body 1 and a sheath 2 covering the surface of the sling body and a guide wire 4 provided at both ends of the sling body and a sleeve for protecting the guide wire a tube 3;
  • the sling body is provided with a hollow mesh structure composed of a plurality of through holes 11, the sling body is a fiber layer made by a fiber accumulation additive manufacturing technique;
  • the edge of the through hole is an arc edge Or a straight edge, and when the edge of the through hole is a straight edge, a smooth transition between the straight edges;
  • the edge of the sling main body is a curved edge;
  • the curved edge is composed of a plurality of repeatedly arranged curved units 12 constitutes.
  • the width of each of the curved repeating units is 1 mm to 10 mm; the spacing of each of the curved repeating units is 0 mm.
  • the upper surface or the lower surface of the sheath 2 is provided with a hole 21 having an area of more than 20% of the total area of the upper surface/lower surface of the sheath.
  • Figure 15 shows an implementation of another tension-free suspension system comprising a sling body 1 and a sheath 2 covering the surface of the sling body and a guide wire 4 provided at both ends of the sling body and a sleeve for protecting the guide wire a tube 3;
  • the sling main body is provided with a hollow mesh structure composed of a plurality of through holes 11, the sling main body is a fiber layer formed by a fiber accumulation additive manufacturing technique;
  • the edge of the through hole is an arc edge or Straight edge, and when the edge of the through hole is a straight edge, a smooth transition between the straight edges;
  • the edge of the sling main body is a curved edge;
  • the curved edge is composed of a plurality of repeatedly arranged curved units 12 Composition.
  • the width of each of the curved repeating units is 1 mm to 10 mm; the spacing of each of the curved repeating units is 0 mm.
  • the sheath 2 is composed of a symmetrically distributed left sheath 22 and a right sheath 23, and the left sheath 22 and the right sheath 23 are each independent; the left sheath 22 and the right sheath 23 correspond to the same body of the sling Holes 221, 231 are provided on the faces, respectively.
  • the area of the holes 221, 231 is more than 20% of the area of the upper surface of the left sheath or the upper surface of the right sheath.
  • the left sheath 22 and the right sheath 23 have a gap at an adjacent end thereof, and the gap is 0.1 cm to 10 cm.
  • the width of the sling body 1 is 7 to 15 mm.
  • Figure 16 illustrates several different shapes of the through holes 11 provided in the main body of the sling, which may be elliptical. Round or square rounded transitional square.
  • the curved edge 12 of the sling body 1 is designed to be constructed of a plurality of repeatedly arranged curved elements 12 as described above.
  • the width of each of the curved repeating units is from 1 mm to 10 mm; the pitch of each of the curved repeating units is 0 mm; or as shown in Fig. 17, the existence of each of the curved repeating units is less than 10 mm.
  • the sleeve 3 comprises a first portion 31 of a straight tubular shape connected to the body 1 of the sling and a second portion 32 of the shape of a bullet.
  • the sleeve 3 has a total length of 5 mm to 20 mm, preferably 10 mm to 16 mm; the first portion 31 has a length of 3 mm to 17 mm, preferably 6 mm to 13 mm; and the first portion 31 has a diameter of 2 mm to 8 mm, preferably 3 mm to 5 mm.
  • the main body of the sling is a tissue support made of electrospun fibers having a diameter of 0.01 ⁇ m to 100 ⁇ m, and the materials used may be polyfluoride materials (PVDF, PTFE, etc.), polyolefins (polyethylene, Non-degradable materials such as polypropylene, polyurethane materials (PU, PCU, TPU, etc.). Its bulkiness and stability do not require additional restrictions.
  • the sheath is provided with a positioning line.
  • the positioning line coincides with a line of symmetry of the sheath in the axial direction; more preferably, a tear line/cut line is provided at the positioning line.
  • the structure of the tensionless suspension belt system of this embodiment is the same as that of the embodiment 14 of Fig. 14 or Fig. 15.
  • the difference is that the main body of the sling is a tissue support composed of fibers having a diameter of 0.01 ⁇ m to 100 ⁇ m, and has a porous structure with a bulkiness of 200 to 2000 cm 3 /g, and the fiber intersection is fused to form a fiber node;
  • the stability S of the tissue scaffold meets the following relationship:
  • T 1 is the initial thickness of the tissue scaffold
  • T 2 is the thickness of the tissue scaffold measured after the mechanical fatigue test, and the thickness is in mm
  • the value of S is 1-3.
  • the sling body described in this embodiment can be made by using a fiber accumulation additive manufacturing technique, or can be prepared by referring to the preparation method described in CN104645420A.
  • the sling body having the above properties has better mechanical properties and repair properties.
  • the tension-free suspension belt system of the present comparative example has the same structure as that described in Fig. 14 of Embodiment 9 except that no hole is provided in the sheath (i.e., the upper and lower surfaces of the sheath are sealed integrally).
  • the resistance test experiment was carried out as follows:
  • the sheathed sling body was passed through the center of a lean beef block having a length of 25 cm and a thickness of 8 cm.
  • a heavy object is placed on the beef to simulate the compressive force of the muscle and fascia tissue on the sling when the sling passes through the human body during the surgical procedure. Then, the part of the main body of the sling exposed from the beef is cut off, and the remaining part is kept still.
  • the traction guide line is slowly pulled out to take out the main part of the sheath and the excess sling, and the mechanical value on the pointer type force gauge is read, and the reset button is pressed after recording. Return to zero and start the next set of tests.
  • the structure of the present invention can reduce the force used when the sheath is taken out. Therefore, it is easier to operate.
  • FIG. 19a shows the force applied with the sheath of Comparative Example 2.
  • the sling is in a folded state in the human tissue. After the cutting at C, when the sheath is taken out, the frictional force is generated between the contact surface of each layer of the sheath and the sling body.
  • the friction resistance of the sheath is significantly reduced after the opening is provided on one side of the sheath. Therefore, the design of the hole on one side of the sheath can eliminate the friction inside the fold of the sling, thereby reducing the force used to remove the sheath.
  • An implementation form of a tension-free suspension strap system comprising a sling main body and a sheath covering the surface of the sling main body, wherein the sheath is as shown in FIG. 20, and includes a sheath body 5 and a cavity formed by the sheath body.
  • One end of the sleeve body is provided with a cavity opening, and the other end is provided with a folded portion 8.
  • the upper surface of the sheath body 5 is provided with a hole 9 communicating with the cavity 6, and the folded portion 8 is folded upward.
  • the hole 9 is contracted from the central portion toward the opening of the cavity, and forms the maximum force point of the hole 9, and an extension is provided at the maximum force point.
  • the edge of the hole 9 is a front portion 91, a middle portion 92, and a rear portion 93 which are sequentially connected from a direction close to the opening of the cavity to a direction away from the opening of the cavity;
  • the front portion 91 includes a first front edge line 911 a junction point 913 formed by intersecting the second front edge line 912 and the two lines, the junction point 913 is a maximum force point, and the distance from the junction point 913 to the edge of the cavity opening is smaller than the number a front edge line, any other point on the second front edge line to the opening edge of the cavity 6;
  • the junction 913 is provided with a cutting line 7 extending to the cavity opening.
  • the middle portion 92 includes a first middle edge line 921 connected to the first front edge line 911 and a second middle edge line 922 connected to the second front edge line 912.
  • the cutting line 7 is coplanar with the axial line of the sheath body 5, so that the direction of the fracture of the sheath body is the same as the direction of the force when the sheath is taken out, the force is more uniform, and the depth H of the cutting line 7 occupies the sheath body where the sheath is located.
  • the thickness value L of 5 is 30 to 90%, preferably 50% of the thickness value of the sheath body in which it is placed.
  • the total area of the holes 9 is 50% to 70% of the area of the upper surface 51 of the sheath body 5 in which it is located, preferably 55% of the area of the upper surface 51 of the sheath body 5 in which it is placed.
  • the folded portion 8 is folded upward, and the folded portion 8 includes a first folded portion 81, a second folded portion 82, an extended portion 83, and a folded portion 84 where the three meet, the end portion 93 of the hole
  • the distance d from the edge line to the folded portion 84 is 2 to 6 cm.
  • the front portion 91 has a semi-elliptical shape, and the first front edge line 911 and the second front edge line 912 are symmetrical with respect to the line on which the cutting line 7 is located.
  • the last edge line 93 has a semi-elliptical shape and is symmetrical with respect to the line on which the cutting line 7 is located.
  • the sheath body 5 has a width of 10 to 15 mm.
  • the first middle edge line 921 and the second middle edge line 922 are mutually parallel straight lines, and the first middle edge line 921 and the second middle edge line 922 are symmetrical with respect to the line where the cutting line 7 is located, and the first middle edge line 921 The distance from the second middle edge line 922 is 6 to 8 mm.
  • the shape of the hole is a racetrack shape (rectangular in the middle and semi-elliptical on both sides).
  • the sheath body 5 is provided with three holes, and the extending direction of each of the hole extending sheath bodies is neatly arranged, and there are also cutting lines between adjacent holes, and cutting The line is coplanar with the axis of the sheath body 5. Further, the distance from the edge line of the end of the hole closest to the folded portion to the folded portion is 2 to 6 cm.

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Abstract

一种软组织修复补片及其制备方法以及无张力悬吊带***。所述软组织修复补片为由直径在0.01μm～10μm的纤维构成的纤维支架，其具有多孔状结构，蓬松度为200～2000cm 3/g，纤维交接处发生融合形成纤维节点。所述软组织修复补片的制备方法包括：由静电纺丝技术制得纤维膜，对纤维膜进行处理使纤维交接处发生融合形成纤维节点。所述无张力悬吊带***包括吊带主体和包覆吊带主体表面的护套，所述吊带主体由纤维膜层构成，所述吊带主体为由多个通孔组成的镂空网格状支架结构，所述护套的上表面或下表面上设置有孔。

Description

软组织修复补片及其制备方法以及无张力悬吊带*** 技术领域
本发明属于组织工程支架领域，涉及一种软组织修复补片及其制备方法以及一种无张力悬吊带***，更具体地涉及应用于各类疝、盆底、尿失禁等疾病的软组织修复补片及其制备方法以及无张力悬吊带***。
背景技术
现代外科手术中，利用组织修复膜对组织和器官进行修复非常常见，如组织修复膜片在疝气修复、女性骨盆底功能障碍性疾病修复、硬脑/脊膜缺损修复、神经导管缺损修复、血管的修复、韧带修复、骨缺损修复等方面的应用。编织网片是目前组织修复用纤维膜中应用最广的产品，但该类产品表面粗糙、质地较硬、不能体内降解、生物相容性差、易产生异物感和疼痛、引起常见侵蚀和感染等并发症；并且该类材料引发的免疫排斥反应较强，存在较多的手术后遗症；其与内脏、器官直接接触时，易造成损伤，可引起较严重的粘连、引发严重的异物和免疫反应，需要二次手术取出，给病人带来痛苦，甚至危及生命。
纤维堆积增材制造技术是一种将聚合物溶液或熔融体在电学、力学、光学、生物或化学反应等作用下形成聚合物纤维，并有序或无序地堆积或沉积，构造成物件的方法。纤维堆积增材制造技术是目前一种简单而有效的制备聚合物纤维的加工方法，采用该方法制备的组织工程支架材料，在组织工程修复中得到了广泛的应用。该方法制备的工程支架在一定程度上能有效地模拟天然细胞外基质结构，给细胞的生长和攀爬提供了良好的微环境，因而具有一定的仿生结构。目前这一特性使纤维堆积增材制造技术制备的纤维膜材料特别适用于生物医用领域，如生物膜、药物输送、组织工程等的支架材料等。目前，静电纺丝、离心力纺丝、热熔喷丝、熔融电纺、电流体动力喷墨打印(EHD jet printing)等技术都属于纤维堆积增材制造技术。
长期的临床观测发现，纤维堆积增材制造技术制备的纤维组织修复支架可诱导成纤维细胞生长、分化，胶原沉积及演化，实现再生组织，并可避免自体疤痕修复强度不足的缺点。实践还发现通过控制纤维支架蓬松度来控制细胞的长入情 况，如加大纤维支架蓬松度可使更多的细胞长入，诱导自身组织更快实现缺损的修复，并带来对缺损软组织更好的力学支撑和功能恢复。发明人在CN103800096A及CN103800097A两份申请中，已经公开了具有一定蓬松度的补片，更进一步地，可以调节补片的柔软度以获得性能更佳的补片。
然而，临床实践中发明人同时发现除了蓬松度及柔软度的因素外，维持支架的孔隙尺寸及孔隙率的长期稳定，对支架材料在体内的长期环境中诱导支架内的细胞生成，及提供稳定结构支撑或功能辅助具有至关重要的作用。
特别是针对用于修复各类疝、盆底、尿失禁等疾病的软组织支架材料，由于该类软组织往往要承受一定的应力变化，如临床中病人咳嗽、便秘等引起腹压升高，修复支架材料会承受一定的拉伸应力，经受长期应力拉伸后，支架的孔隙尺寸及孔隙率发生了变化，因此维持上述支架的孔隙尺寸及孔隙率的长期稳定性更为重要。实验表明，支架的孔隙尺寸及孔隙率发生了变化将导致支架材料修复效果偏离预期。正如发明人前两份专利所公开的技术，该补片虽然有较佳的蓬松度和柔软度，然而其长期稳定性较差，容易发生变形，容易发生细胞生长过快，带来增生等新问题。因此，制备一种具备良好蓬松度及柔软度，并且在体内的长期融合和演化过程中，保持孔隙尺寸和孔隙率的稳定，使细胞生长、分化维持在合理水平的支架材料，十分有意义。
压力性尿失禁(Stress Urinary Incontinence，SUI)又称张力性尿失禁，是女性骨盆底功能障碍性疾病中常见的一种，主要表现为腹内压增高时，尿道***弛缓和无力形成的尿液随意流出。尿失禁常会导致患者丧失自尊、尴尬，使患者的社会活动及性活动减少，长期将导致患者抑郁，失禁也是将老年人送交护理机构的最普遍原因。
目前治疗SUI最有效、最彻底的方法是进行无张力吊带手术，对尿道起到承托的作用，使其解剖位置回复正常。现有吊带产品主要为编织聚丙烯制成的，但该类产品长期植入人体会出现变形，导致侵蚀、暴露、感染等并发症，侵蚀是指现有的吊带在植入后容易向膀胱、输尿管侵犯，且范围会渐渐扩大，暴露于腔内的吊带面积范围会逐渐变大，从而引起尿路刺激症、反复***、尿瘘等相应部位的症状。使患者出现***异常分泌物增多、流血、***困难、疼痛等。进一步地，由于吊带在植入过程需要穿插经过多个组织，常见地吊带易割伤经过的 组织和脏器，容易造成疼痛甚至感染；而且，吊带在体内被牵引的过程中，脏器和组织与吊带发生的摩擦力，易使吊带发生形变并影响对“吊床”功能缺陷的修复的力学调节操作。
尽管发明人此前已经有公开纤维堆积增材制造技术制备得到的无张力悬吊带，能够克服一些现有材料带来的并发症，由于并未对临床的客观情况及吊带产品的结构进行深入开发，因此依然存在改善的空间，以使病人获得生物相容性好，并发症低，降低植入过程的风险(如割伤脏器，吊带变形、断裂等)，便于手术操作的安全、有效的产品。
另外，无张力悬吊带在植入人体时因阻力较大而增加手术难度，或者在植入过程中由于拉扯而发生不可控的形变，给临床使用带来不可控制的风险，影响最终的治疗效果。因此，降低吊带在植入过程的阻力，且能在整个过程中保护吊带，避免拉扯导致的形变对SUI的有效治疗尤为重要。现有技术中是在吊带主体上覆盖护套，但现有护套通常是一个完整的平面结构，其与人体组织的接触面很大，且在植入时吊带穿过组织会发生卷曲，被卷入内部的护套部分挤压力很大，因此在取出护套的过程中会产生较大阻力，有时候甚至发生护套断裂的情况。
发明内容
本发明的目的在于克服现有技术中的不足，提供一种适用于软组织修补的补片，该补片具备良好蓬松度，有利于细胞和组织的快速粘附和增殖、引导细胞分化，有利于组织之间的紧密贴合，同时其在长期的体内融合和演化过程中，保持孔隙尺寸和孔隙率的稳定。
本发明的另一个目的在于提供上述适用于软组织修补的补片的制备方法。
本发明的另一个目的在于提供一种无张力悬吊带***。
为实现上述目的，本发明采用如下技术方案：
一种软组织修复补片，所述软组织修复补片为由直径在0.01μm～10μm的纤维构成的组织支架，具有多孔状结构，其蓬松度为200～2000cm3/g，纤维交接处发生融合形成纤维节点；
所述组织支架的稳定度S符合以下关系：
Figure PCTCN2015099217-appb-000001
其中T1为组织支架初始厚度，T2为力学疲劳试验后测得组织支架的厚度，厚度单位mm；S的数值为1～3。
发明人发现，通过使相邻电纺丝纤维间形成稳定的连接方式，并且满足上述关系的软组织修补片不仅具备良好蓬松度，有利于细胞和组织的快速粘附和增殖、引导细胞分化，有利于组织之间的紧密贴合，同时其在长期的体内融合和演化过程中，能够保持孔隙尺寸和孔隙率的稳定。
稳定度是指组织支架的初始厚度与力学疲劳试验后测得组织支架的厚度之比。本发明中，所述组织支架的稳定度S测试中，各参数的测试方式参考如下方法：
所述组织支架初始厚度的测试方法为利用FAST-1压缩性织物风格仪按照GB/T 7689.1-2001方法进行测试，表示组织支架在2cN/cm2压强下厚度；
所述力学疲劳试验为根据软组织修复补片在体内不同位置的需求，在2～50MPa拉伸强度内，拉伸1000～4000000次。
当所述软组织修复补片作为无张力悬吊带材料时，其力学疲劳试验为所述力学疲劳试验为，在10MPa拉伸强度内，拉伸500000次。
优选地，所述S的数值为1～2。
所述力学疲劳试验的拉伸强度及拉伸次数本领域技术人员可以根据软组织修复补片在体内不同位置的需求进行选择，这些需求可以从临床医生解剖文献中找到相应的参考数据。
优选地，所述软组织修复补片的厚度为0.15～2mm。
所述纤维交接处发生融合形成纤维节点为在纤维间交叉搭接处发生融合形成的微观节点或在纤维间并排接触处发生融合形成的宏观节点。
优选地，所述微观节点的形状呈团状，平均直径为10nm～10μm。
优选地，所述宏观节点呈线状、团状，线状宏观节点的线宽为25～1000μm；团状宏观节点的平均直径为25～1000μm。
本发明中，所述的团状，包括表面规则的球形，或表面不规则的球形；该团 状物是由于纤维融化后发生团聚形成的。
优选地，所述线状宏观节点的线宽为50～500μm；团状宏观节点的直径为50～500μm。
优选地，任意两个所述宏观节点的间距为100～5000μm。更优选地，任意两个所述宏观节点的间距为100～1000μm。
优选地，所述软组织修复补片的蓬松度为200～2000cm3/g。
优选地，所述软组织修复补片的柔软度为50～500毫牛顿。
优选地，所述软组织修复补片的柔软度为200～450毫牛顿。
本发明所述的蓬松度及柔软度可以参考CN103800096A，即本发明所述蓬松度是指由0.01μm～10μm的纤维构成的组织支架的表观厚度与面密度之比的1000倍，即
蓬松度＝组织支架的表观厚度T3/面密度ω×103，
其中，蓬松度以cm3/g表示，表观厚度以mm表示，面密度以g/m2表示。组织支架的表观厚度T3的测试方法是利用FAST-1压缩性织物风格仪按照GB/T7689.1-2001方法进行测试，表示为组织支架在2cN/cm2压强下厚度(mm)与组织支架在100cN/cm2压强下厚度(mm)之差。面密度ω的测试方式是在忽略组织支架的厚度的情况下，测定的单个面单位面积下的重量。
本发明所述的柔软度是指根据GB/T 8942-2002中方法测试出来的组织支架抗弯曲力和组织支架与缝隙处摩擦力的最大矢量之和，以毫牛顿表示，柔软度值越小说明膜越柔软。
本发明中，构成所述纤维的材料为聚氨酯类、聚酯类或氟类材料，更具体地，包括L-聚乳酸(PLLA)、聚偏二氟乙烯(PVDF)、聚己内酯(PCL)和聚氨酯等。
所述软组织修复补片可以由纤维堆积增材制造技术制得纤维膜，然后对纤维膜进行处理使纤维交接处发生融合形成纤维节点得到。
优选地，所述软组织修复补片通过静电纺丝技术制得纤维膜，然后对纤维膜进行处理使纤维交接处发生融合形成纤维节点得到。
具体的，一种上述软组织修复补片的制备方法，可以有多种方案，作为一种可选方案1，包括如下步骤：
S1.将纤维材料与溶剂体系配置为均一溶液，得到均一的纤维材料溶液；所述溶剂由溶剂A和溶剂B组成，溶剂A与溶剂B的体积比为1:9～9:1；溶剂A 的沸点高于80℃，溶剂B的沸点低于60℃；
S2.将步骤S1.中得到的纤维材料溶液装入静电纺丝注射器中，进行静电纺丝得到纤维丝，并将纤维丝接收为膜状结构，得到纤维膜；
S3.将步骤S2.中得到的纤维膜经热压或冷压后热烘干，得到所述软组织修复补片；所述热压或冷压的压力范围为103Pa～106Pa；热压温度范围为50℃～300℃；冷压温度为室温。优选地，所述热压温度范围优选为70℃～200℃。
S1中，优选地，溶剂A与溶剂B的沸点温度之差大于30℃。
上述软组织修复补片的制备方法，作为一种可选方案2，包括如下步骤：
S1.采用具有不同熔点的两种纤维材料分别溶于溶剂中，分别制成纤维材料溶液；
S2.将步骤S1中得到的纤维材料溶液装入静电纺丝注射器中，进行静电纺丝得到纤维丝，并将纤维丝接收为膜状结构，得到纤维膜；
S3.所述纤维膜在熔点较低的材料的Tm以下80℃到Tm温度的范围之间进行热压后，得到所述软组织修复补片。
Tm为材料的熔融温度。
上述可选方案1及可选方案2的步骤S2中，优选先对纤维丝进行定向取向，再进行余下步骤。定向取向可以进一步减少不同纤维间的夹角、作用力侧向分量，减少力对纤维节点的影响，以增强支架材料在人体内演化的长期稳定性。杂乱排布的电纺纤维，一根纤维呈弯曲卷绕状态，可呈现较大的变形特性；细胞长入电纺支架后，弯曲状态的纤维易于被长入的细胞拉展，造成支架材料的变形，影响术后恢复效果。
具有本发明所述性能的补片也可以通过在常规方法的基础上改进得到，下面列举两种可行的方式：
作为一种可选方案3，包括如下步骤：按常规方法制备电纺丝纤维膜，采用0.1w～10w功率的激光对纤维材料进行加热，激光头扫描速度为0.1～1000mm/s，激光束宽度为25～1000μm，使用激光束在膜表面扫描条纹间距为50～5000mm的格栅花纹，使纤维材料发生部分融化且不发生气化，得到所述软组织修复补片。
作为一种可选方案4，包括如下步骤：按常规方法制备电纺丝纤维膜，使用尖端直径为25～1000μm，针头阵列纵横向间距皆为50～5000μm的焊接头部构件 对电纺膜进行高分子焊接方式使纤维发生部分融化得到；焊接温度为50℃～300℃。
进一步地，优选使用尖端直径为25～100μm，针头阵列纵横向间距皆为500～3000μm的焊接头部构件对电纺膜进行高分子焊接。
所述常规方法，包括制备电纺丝溶液、纺丝并接收成膜的步骤，工艺条件可以参考现有的静电纺丝纤维膜制备的工艺条件。
所述高分子焊接方式可以是加热焊接、超声焊接或电阻焊接；焊接温度根据材料的性质进行选择。
优选地，在上述各个方案的所有步骤完成后，再进行拉伸操作。拉伸操作可以控制节点强化材料的孔隙度。
本发明所述的软组织修复补片的应用，可以是将其根据需要，制备成不同的产品，如常见的各类疝补片、盆底修补片或无张力悬吊带等。
本发明提供一种无张力悬吊带***，所述无张力悬吊带***包括吊带主体和包覆吊带主体表面的护套；所述吊带主体由纤维膜层构成，所述吊带主体为由多个通孔组成的镂空网格状支架结构；所述护套的上表面或下表面上设置有孔。
优选地，所述吊带主体由具有仿生结构的纤维膜层构成。
所述具有仿生结构的纤维膜层的制备方法可以用现有的制备方法制得。
优选地，所述具有仿生结构的纤维膜层由纤维堆积增材制造技术制得。
优选地，所述纤维膜层是通过静电纺丝技术制得。
所述仿生结构是指模拟天然细胞外基质的结构。
所述吊带主体上的通孔，可以通过激光雕刻、冲压、局部压熔、机械切割等方法制得。由于吊带主体上有多个通孔，其排列类似网格状，因而吊带主体呈镂空网格状支架结构。
上述吊带主体上的镂空网格状支架结构有利于诱导自体细胞生长，形成***，强化尿道周边组织，且吊带主体具有优化的强度与弹性，同时所述通孔的边缘设计成弧边或圆滑过渡可以避免了尖锐角对组织的刺激。现有技术为了减少吊带主体植入过程的阻力，通常选择在吊带主体的表面增加一个护套。然而，现有的护套通常是一个完整的平面结构，其与人体组织的接触面很大，因此在取出护套的过程中，受到较大的阻力。发明人发现，在护套的一个面上设置孔，可以减少护套与人体组织的接触面积，能够显著减少护套取出时产生的阻力，同时也 能减少吊带植入过程中的阻力，大大提高了吊带植入手术的方便性和操作性。
本发明中，吊带在人体内活动主要包括在手术时对吊带进行的牵引，以及在手术完毕后，将护套从吊带主体上分离取出。
护套上的孔的面积大小与护套取出时产生的阻力变化成反比，孔的面积越大，护套取出时的阻力越小。优选地，所述护套上的孔的总面积占其所在的护套上表面或下表面总面积的10％以上。为了更好地达到减少活动过程中对人体组织的阻力，优选所述护套上的孔的总面积占其所在的护套上表面或下表面总面积的20％～50％。
所述护套可以是一体成型的护套，也可以由两个子护套组成。为了更好地使护套与吊带主体分离，优选使用子护套的形式。因而，优选地，所述护套包括对称分布在吊带主体左半部和右半部的第一护套和第二护套；所述第一护套和第二护套分别由吊带主体的两端向吊带主体的中央延伸，且第一护套和第二护套各自独立；所述第一护套和第二护套的上的孔位于同一面。
护套上的孔的数量可以是一个或多个。
优选地，设于第一护套和/或第二护套上的孔的数量为1～5个。
优选地，所述第一护套与第二护套在其相邻一端存在间隙。优选地，所述间隙为0.1cm～10cm。
为了达到较好的自体化效果，吊带的表面需要具有一定的粗糙度方便细胞的爬行及长入；另一方面，由于吊带植入位置为尿道和***前壁间隙，日常活动将导致吊带与柔软的尿道直接接触摩擦，当吊带表面粗糙度较大时，日常活动中，吊带将对尿道造成磨损，长时间的磨损将有可能导致尿道侵蚀的发生。优选地，所述吊带主体的上表面及下表面的粗糙度均为0.1μm～50μm。控制在此粗糙度的范围内，能更好地满足细胞爬行长入，并减少吊带对尿道的磨损。
吊带主体上的通孔的形状可以是规则的形状或不规则的形状。优选地，所述通孔的形状为圆形、椭圆形或设有倒角的多边形。
吊带主体上的通孔的孔径越大，越能提高无张力悬吊带与人体组织的相容性，优选地，所述通孔的孔径为1.5～5mm。更优选地，所述通孔的孔径为3～4.5mm。更优选地，所述通孔的孔径为4mm。
吊带主体上的通孔的分布密度对无张力悬吊带的力学性能有一定的影响。一般地，如果在吊带主体上的开孔量过多会导致无张力悬吊带的机械性能明显下 降。优选地，所述通孔在吊带主体上的分布密度为1～10个/cm2。更优选地，所述通孔在吊带主体上的分布密度为2～8个/cm2。更优选地，所述通孔在吊带主体上的分布密度为3～6个/cm2。
吊带主体的厚度越大，对周边组织的刺激越大，并发症发生几率越高，且病人术后将明显有异物感。但过于薄的吊带将会对周边组织造成切割。
优选地，所述吊带主体的厚度为0.1mm～1mm。优选吊带主体的厚度为0.2～0.25mm；由于吊带植入位置为***前壁，对于有性生活的使用者，较厚的吊带将使其感受到异物感及刺痛；当降低吊带的厚度为0.25mm及以下时，病人异物感将显著降低。
为了更便于医生进行手术操作，优选地，所述护套上设置有定位线。
对于一体成型的护套，为了更好地实现护套与吊带主体的分离，所述定位线可作为护套裁剪定位线，优选地，所述裁剪定位线与护套在吊带主体的轴向上的对称线重合。
优选地，所述无张力悬吊带***的两端设有导引线。导引线的设计，能更便于手术操作。优选地，所述导引线与吊带主体的连接处设有用于保护导引线及方便穿刺的套管。导引线与吊带主体的连接处暴露在外，容易损坏，增设套管能提高连接处的寿命。同时能够便于吊带***穿过人体组织，植入人体体内。优选地，所述套管整体长度为5mm～20mm，更优选为10mm～16mm；套管直径为2mm～8mm，优选3mm～5mm。
所述无张力悬吊带***的两端设有导引线和套管，所述套管的一端与护套及吊带主体连接，另一端呈锥体形；所述导引线的一端与护套及吊带主体连接，另一端穿过套管的锥体形端部开口延伸至套管外。锥体形的套管，能减少穿刺过程的阻力。
优选地，所述套管的一端与护套及吊带主体连接，另一端呈子弹头形状。所述导引线的一端与护套及吊带主体连接，另一端穿过套管的子弹头形状的端部开口延伸至套管外。优选地，套管包括由与护套及吊带主体连接的呈直管状的第一部分及呈子弹头状的第二部分。更优选地，所述套管第一部分的长度为3mm～17mm，优选6mm～13mm。优选地，所述套管由具有高顺滑表面性质的聚全氟乙烯丙烯共聚物组成。采用上述形状和材料制备的套管，能够减少穿刺过程中对组织及血管的损伤。
为了更好地减少带有护套的吊带在人体内活动时与人体组织之间的阻力，优选所述护套具有光滑的表面，护套的材料优选为是聚乙烯或聚丙烯。
所述吊带主体的边缘设计弧形边缘，能减少吊带边缘对组织的切割刺激，具有降低尿道及***侵蚀暴露几率的作用，同时，能够为吊带提供一定的固定力。特别对于纤维堆积增材制造技术制成的吊带主体，由于纤维堆积增材制造技术制成的吊带主体表面比较平整，不存在编织制成的吊带主体表面的毛刺或倒勾，因此纤维堆积增材制造技术制成的吊带主体与组织的固定力通常较低。而将吊带主体边缘设计成弧形边缘，则可以提升纤维堆积增材制造技术制成的吊带主体的固定力。
优选地，所述弧形边缘由多个重复排列的弧形单元组成。进一步地，每个弧形单元的宽度为1mm～10mm，优选宽度为3～7mm；相邻两个弧形单元的间距为为0mm～10mm，优选间距为3～7mm。
所述吊带主体的机械性能要求可以参考现有吊带产品的机械性能，或参考正常女性***前壁的伸长率及尿失禁悬吊要求。优选地，所述吊带主体在承受2kg重力时的伸长率为10％～50％，更优选为15％～30％，更优选为20％～25％。在此范围内，能提高吊带主体的自体化能力。吊带主体的自体化能力是吊带修复效果的一个反映。自体化能力越高，吊带主体更容易允许细胞、组织长入，与人体组织的粘附性强，生物相容性佳，吊带的材料及结构稳定，长期使用过程中无新释放出的材料和物质影响生物相容性，同时具有较好的抗感染能力。
所述吊带主体在承受2kg重力时的伸长率的测定方法是：将吊带主体裁剪为长度为50mm，宽11mm的样条，采用万能拉力试验机进行测定，加载模式为定载荷模式，载荷数值设定为19.6N，然后用拉力试验机的夹具将吊带主体样条的两端夹住，拉力试验机调零后进行拉力测试，拉伸条件为：拉伸速度为50mm每分钟，夹具间距为40mm。记录吊带主体在19.6N拉力时的拉伸伸长率。
优选地，所述吊带主体的宽度为7～15mm。优选所述吊带主体的宽度为9mm～11mm。
优选地，所述护套包括护套主体和护套主体形成的容腔，护套主体的一端设有容腔开口，另一端设有折叠部，所述护套主体上表面设有所述孔，所述折叠部朝上折叠。优选地，所述孔由中部向容腔开口处收缩，并形成所述孔的最大受力点，所述最大受力点处设有一延伸至容腔开口的切割线。
由于护套在使用时通常是通过牵引护套远离容腔开口的一端往体外抽出，在抽出的过程中，孔上的最大受力点容易发生不规则的撕裂，这种撕裂容易产生碎片残留在人体内。通过增加切割线，当护套取出时，护套会沿着切割线发生较规整的断裂，避免了上述不良影响。
更具体地，所述护套可以是如下结构：包括护套主体和用于容纳吊带主体的容腔，所述护套主体上设有与所述孔，所述孔的边缘由靠近容腔开口的方向至远离容腔开口方向为依次相连的前部、中部、末部；所述前部包括第一前边缘线和第二前边缘线以及这两条线相交而形成的交汇点，所述交汇点为最大受力点，且所述交汇点到所述容腔开口边缘的距离小于所述第一前边缘线、第二前边缘线上其它任意一点到所述容腔的开口边缘的距离；所述交汇点设有一延伸至容腔开口的切割线。
优选地，所述切割线与所述护套主体的轴心线共平面。使得护套的断裂方向与护套取出时的受力方向相同，受力更加均匀，减少阻力。进一步地，所述第一前边缘线和所述第二前边缘线以所述切割线与所述护套主体的轴心线所共的平面为对称面。
为了平衡护套作用于吊带时的稳固性和护套取出时的难易程度，优选地，所述切割线的深度占其所在护套主体的厚度的30～90％，更进一步地，占其所在护套主体的厚度的50％。
在满足上述条件的前提下，所述前部、中部、末部的边缘线可以是任意形状的线段。
所述中部包括与第一前边缘线相连的第一中边缘线和与第二前边缘线相连的第二中边缘线。为了使得所述第一中边缘线与第二中边缘线受力均衡，更优选地，所述第一中边缘线和所述第二中边缘线以所述切割线与所述护套主体的轴心线所共的平面为对称面。
所述护套主体的宽度为10～15mm，更优选地，所述第一中边缘线与所述第二中边缘线之间的距离为6～11mm。
所述折叠部包括第一折叠部、第二折叠部、延长部以及三者交汇的折叠处。为了更便于手术时对护套内的纤维膜层进行剪裁，优选所述孔的末部的边缘线到折叠处的距离为2～6cm。
优选地，当孔的数量为多个时，各孔延护套的延伸方向整齐排列分布。
当孔的数量为多个时，则最接近折叠部的孔的末部的边缘线到折叠处的距离为2～6cm。更优选地，相邻各孔之间存在切割线。更优选地，所述切割线与所述护套主体的轴心线共平面。
为了更好地减少护套与人体组织之间的阻力，优选地，所述护套具有光滑的表面，护套的材料优选为是聚乙烯或聚四氟乙烯。
所述纤维膜层可以通过任意材料制成，只要这些材料制成的纤维膜层具有所述功能。优选地，使用常规的不可降解材料制成。所述不可降解材料主要包括聚氟类材料(PVDF、PTFE等)、聚烯烃(聚乙烯、聚丙烯等)、聚氨酯类材料(PU、PCU、TPU等)等不可降解材料。
更优选，将所述不可降解材料通过加工方法，制成具有一定蓬松度和稳定度的材料，如加工成上述软组织修复补片，具备良好蓬松度，有利于细胞和组织的快速粘附和增殖、引导细胞分化，有利于组织之间的紧密贴合，同时其在长期的体内融合和演化过程中，保持孔隙尺寸和孔隙率的稳定。
优选地，所述纤维膜层为由直径在0.01μm～100μm的纤维构成的纤维膜组织支架，具有多孔状结构，其蓬松度为200～2000cm3/g，其纤维交接处发生融合形成纤维节点；
所述组织支架的稳定度S符合以下关系：
Figure PCTCN2015099217-appb-000002
其中T1为组织支架初始厚度，T2为力学疲劳试验后测得组织支架的厚度，厚度单位mm；S的数值为1～3。
优选地，所述纤维膜层为由直径在0.1μm～10μm的纤维构成的纤维膜组织支架。因此，优选地，所述纤维膜层为上述软组织修复补片，其可以由上述软组织修复补片的制备方法制备。
与现有技术相比，本发明具有如下有益效果：
本发明所提供的软组织修复补片能够满足人体内不同细胞所需的不同孔径、孔隙；强化了纤维间的结合力并且优化了纤维取向排布，使纤维支架形成稳定的 孔隙结构；在细胞长入及长期演化过程中，本发明所提供的软组织修复补片能够维持孔径、孔隙和形状的稳定性。
本发明的软组织修复补片具有较好的细胞长入特性，并通过使巨噬细胞增殖及诱导新的毛细血管形成，达到植入的补片与自身组织融合在一起的目的。所述软组织修复补片，在长期的体内环境中能提供稳定的结构支撑或功能辅助因而可以作为一种在人体内长期演化过程中具有更好的细胞生长及更稳定的结构的组织修复产品。
本发明所述的无张力悬吊带***，通过对吊带主体和护套结构的设计，提高了吊带产品的自体化性能，通过在护套的一个面上设置孔，减少护套与人体组织的接触面积，从而显著减少带有护套的吊带在人体内活动时产生的阻力，大大提高了护套取出或对吊带进行牵引时的方便性和操作性。所述吊带在植入人体的过程中，对人体组织的刺激小，长期植入后，能诱导自体细胞迅速沿吊带主体纤维间的微孔生长，形成***并强化尿道周边组织，从而使尿道周边组织恢复或接近正常的生理功能，本发明所述的无张力悬吊带***能显著减少异物感及侵蚀、暴露、感染等并发症的发生。进一步地，通过在护套上设置所述切割线，当护套取出，受到较大压力时，护套可容易地沿切割线断裂，形成规整的裂痕，能够进一步减小取出护套时因撕裂产生碎屑留在体内的风险，便于手术操作及提高手术安全性。
附图说明
图1是实施例7补片的生物相容性及新生组织生长情况；
图2是对照组补片的生物相容性及新生组织生长情况；
图3是对照组补片的生物相容性及新生组织生长情况；
图4是实施例1制备的补片的扫描电镜图，该图中白色圆环内为纤维间交叉搭接形成的团状微观节点；
图5是实施例1制备的补片的扫描电镜图，该图中白色圆环内为交叉纤维之间形成的较为牢固的团状微观节点；
图6是对比例1的补片的扫描电镜图；
图7是实施例6的补片的扫描电镜图；
图8是实施例7制备的补片的团状节点图；
图9是实施例7制备的补片的团状节点细节图；
图10是实施例7制备的补片的团状节点纤维微观熔接形貌；
图11是实施例7制备的补片的线状节点图；
图12是实施例8制备的补片的节点扫描电镜图；
图13是实施例8制备的补片的节点的扫描电镜图。
图14为实施例9所述无张力悬吊带***的一种结构示意图；
图15为实施例9所述无张力悬吊带***的一种结构示意图；
图16为实施例9所述吊带主体上设置的通孔的结构示意图；
图17为实施例9所述吊带主体边缘的结构示意图；
图18为实施例9所述套管的结构示意图。
图19为护套在被牵引或取出时的受力示意图。
图20为实施例11所述护套的结构示意图。
图21为实施例12所述护套的结构示意图。
图22为实施例12所述护套主体与切割线的局部示意图。
图23为实施例12所述护套主体侧视图(容腔开口方向)。
图24为实施例13所述护套的结构示意图。
图25为实施例14所述护套的结构示意图。
具体实施方式
下面给出实施例以对本发明进行具体的描述，有必要在此指出的是以下实施例只用于对本发明进行进一步说明，不能理解为对本发明保护范围的限制，该领域的技术熟练人员根据本发明内容对本发明作出的一些非本质的改进和调整仍属本发明的保护范围。
实施例中所用到的原料均为市售原料。
稳定度测试中，力学疲劳性能测试按照应用于吊带的补片的要求进行测试，具体条件为使用BOSE公司ElectroForce(ELF)实验机进行动态疲劳测试，测试条件如下：
制备试样尺寸：50mm×10mm×0.5mm(长×宽×厚)；
力学实验机加载区间：低值4N至峰值50N；
温度：37℃；
模拟体液浸泡；
疲劳加载次数：500000次；
实施例1：
(1)将L-聚乳酸(PLLA)溶于体积比为4:6的二氯甲烷/1,4二氧六环的混合溶剂，使PLLA在溶液中的浓度为6g/100mL；
(2)将步骤(1)中得到的纤维丝材料溶液装入静电纺丝注射器中，调节微量注射泵的速率为2ml/h，调节高压发生器的电压为15KV，调节接收装置的接收距离为15cm，进行静电纺丝得到纤维，并将纤维接收为膜状结构，纺至膜层厚度约为0.5mm后关闭静电纺丝，得到纤维膜。
(3)将上述纤维膜采用模压机，设定温度为室温、压力为0.1Mpa，加压时间为20s。冷压后将其放入温度为45℃的鼓风干燥箱。烘干12小时后取出，得到纤维节点强度适中的可降解组织修复膜。
实施例2：
(1)将聚偏二氟乙烯(PVDF)溶于体积比为4:6的N,N-二甲基甲酰胺/丙酮的混合溶剂，使PVDF在溶液中的浓度为15g/100mL；
(2)将步骤(1)中得到的纤维丝材料溶液装入静电纺丝注射器中，调节微量注射泵的速率为4ml/h，调节高压发生器的电压为30KV，调节接收装置的接收距离为25cm，进行静电纺丝得到纤维，并将纤维接收为膜状结构，纺至膜层厚度约为0.5mm后关闭静电纺丝，得到纤维膜。
(3)将上述纤维膜采用模压机，设定温度为60℃、压力为0.4Mpa，加热压时间为20s。热压后将其放入温度为60℃的鼓风干燥箱。烘干12小时后取出，得到纤维节点强度较高的不可降解组织修复膜。
实施例3：
(1)将聚偏二氟乙烯(PVDF)溶于体积比为4:6的二甲基乙酰胺/异佛尔酮的混合溶剂，使PVDF在溶液中的浓度为15g/100mL；
(2)将步骤(1)中得到的纤维丝材料溶液装入静电纺丝注射器中，调节微量注射泵的速率为4ml/h，调节高压发生器的电压为30KV，调节接收装置的接 收距离为25cm，进行静电纺丝得到纤维，并将纤维接收为膜状结构，纺至膜层厚度约为0.5mm后关闭静电纺丝，得到纤维膜。
(3)将上述纤维膜采用模压机，设定温度为70℃、压力为0.8Mpa，加热压时间为20s。热压后将其放入温度为60℃的鼓风干燥箱。烘干12小时后取出，得到纤维节点强度更高的不可降解组织修复膜。
实施例4：
(1)将低规整度聚丙烯溶于体积比为4:6的N,N-二甲基甲酰胺/环己烷的混合溶剂，使低规整度聚丙烯在溶液中的浓度为7g/100mL；将高规整度聚丙烯溶于体积比为4:6的N,N-二甲基甲酰胺/环己烷的混合溶剂，使溶液中高规整度聚丙烯的浓度为7g/100mL，得到均一的纤维丝材料溶液。
(2)将上述两种均一的纤维丝材料溶液分别装入4个静电纺丝注射器中，其中2支注射器装低规整度聚丙烯溶液，2支注射器装高规整度聚丙烯溶液。调节微量注射泵的速率为4ml/h，调节高压发生器的电压为25KV，调节接收装置的接收距离为18cm，通过两种材料的同时静电共纺制备出两种溶解性质不同的纤维丝错综交叉的纤维膜，达到0.5mm厚度后关闭静电纺丝。
(3)将上述纤维膜烘干后，采用模压机，设定温度为140℃、压力为0.3Mpa，加热压时间为80s。得到纤维节点强化的不可降解组织修复膜。
实施例5
(1)将L-聚乳酸(PLLA)溶于六氟异丙醇(HFIP)溶液中，使L-聚乳酸(PLLA)在溶液中的浓度为5g/100mL；将聚己内酯(PCL)溶于六氟异丙醇(HFIP)溶液中，使聚己内酯(PCL)在溶液中的浓度为5g/100mL，得到均一的纤维丝材料溶液。
(2)将上述两种均一的纤维丝材料溶液分别装入4个静电纺丝注射器中，其中2支注射器装L-聚乳酸(PLLA)溶液，2支注射器装聚己内酯(PCL)溶液。调节微量注射泵的速率为2ml/小时，调节高压发生器的电压为15KV，调节接收装置的接收距离为15cm，通过两种材料的同时静电共纺制备出两种溶解性质不同的纤维丝错综交叉的纤维膜，达到0.5mm厚度后关闭静电纺丝。
(3)将上述纤维膜烘干后，采用模压机，设定温度为60℃、压力为0.3Mpa，加热压时间为80s。得到纤维节点强化的可降解组织修复膜。
实施例6
(1)将聚偏二氟乙烯(PVDF)溶于体积比为4:6的N,N-二甲基甲酰胺/丙酮的混合溶剂，使PVDF在溶液中的浓度为15g/100mL；
(2)将步骤(1)中得到的纤维丝材料溶液装入静电纺丝注射器中，调节微量注射泵的速率为4ml/h，调节高压发生器的电压为30KV，调节接收装置的接收距离为25cm。
该接收装置采用施加电场、网栅式接受器及高转速等方式，对纤维进行取向，得到较少扭曲纤维的、纤维取向排布规整的纤维膜。
进行静电纺丝得到纤维，并将纤维接收为膜状结构，纺至膜层厚度约为0.5mm后关闭静电纺丝，得到纤维膜。
(3)将上述纤维膜采用模压机，设定温度为60℃、压力为0.2Mpa，加热压时间为20s。热压后将其放入温度为60℃的鼓风干燥箱。烘干12小时后取出，得到纤维节点强度较高的不可降解组织修复膜，且该膜可进一步提高植入后长期演化的稳定性。
实施例7
(1)将聚偏二氟乙烯(PVDF)溶于体积比为4:6的N,N-二甲基甲酰胺/丙酮的混合溶剂，使PVDF在溶液中的浓度为15g/100mL；
(2)将步骤(1)中得到的纤维丝材料溶液装入静电纺丝注射器中，调节微量注射泵的速率为4ml/h，调节高压发生器的电压为30KV，调节接收装置的接收距离为25cm，进行静电纺丝得到纤维，并将纤维接受为膜状结构，纺至膜层厚度约为0.5mm后关闭静电纺丝，得到纤维膜。
(3)将上述烘干后的纤维膜，放入激光裁切机内。对焦后，设定激光功率为1W，激光头扫描速度为1000mm/s，激光束宽度为50μm。使用激光束在膜表面扫描条纹间距为1mm的格栅花纹。得到进一步强化膜表面纤维节点强度的不可降解组织修复膜。
实施例8
(1)将聚偏二氟乙烯(PVDF)溶于体积比为4:6的N,N-二甲基甲酰胺/丙酮的混合溶剂，使PVDF在溶液中的浓度为15g/100mL；
(2)将步骤(1)中得到的纤维丝材料溶液装入静电纺丝注射器中，调节微量注射泵的速率为4ml/h，调节高压发生器的电压为30KV，调节接收装置的接收距离为25cm，进行静电纺丝得到纤维，并将纤维接受为膜状结构，纺至膜层厚度约为0.5mm后关闭静电纺丝，得到纤维膜。
(3)将上述烘干后的纤维膜，放入超声焊接机内。使用尖端直径为100μm，针头阵列纵横向间距皆为3mm的焊接头部构件对纤维膜进行超声焊接，得到纤维节点强度较高的组织修复膜。
对比例1：
(1)将聚偏二氟乙烯(PVDF)溶于体积比为4:6的N,N-二甲基甲酰胺/丙酮的混合溶剂，使PVDF在溶液中的浓度为15g/100mL；
(2)将步骤(1)中得到的纤维丝材料溶液装入静电纺丝注射器中，调节微量注射泵的速率为4ml/h，调节高压发生器的电压为30KV，调节接收装置的接收距离为25cm，进行静电纺丝得到纤维，并将纤维接受为膜状结构，纺至膜层厚度约为0.5mm后关闭静电纺丝，得到纤维膜。
(3)将上述纤维膜放入75％的酒精溶剂中浸泡并做超声处理30分钟，得到较为蓬松的纤维膜。
实施例1～8及对比例1制备的纤维膜的部分参数归纳如表1：
Figure PCTCN2015099217-appb-000003
Figure PCTCN2015099217-appb-000004
动物实验：
皮下与肌肉层间植入实验(样品的生物相容性及新生组织生长情况实验)
实验动物选用新西兰兔，体重2.2Kg，年龄6-12个月，共27只。将实验兔随机分成9组，每组3只实验动物，进行3个月观察期的兔子皮下植入。材料实验组分别选用实施例1～8的膜片，对照组为对比例1的膜片，将材料均裁剪为长宽为1×4cm。分别植入兔子腹部皮下肌肉层，于术后3个月观察材料的组织生长情况。
植入方法：去除家兔腹部被毛，消毒，手术刀轻轻切开皮肤，不切开肌肉，用无齿镊轻提腹中线旁的筋膜，同时用手术刀沿腹中线切开筋膜，不损伤肌肉，手术刀柄钝性将皮下筋膜与肌肉分离，暴露出适宜的材料植入范围。所有实验动物，在皮下筋膜与肌肉层间植入样品，将材料用4号线固定在相应的位置，缝合。
术后3个月，解剖实验动物，实验组样品生物相容性较好。肉眼可见，实验 组表面毛细血管丰富，膜片的两面均可见有新生组织；而且膜片较好地维持了原有的孔径、孔隙和形状，以图1为例(图1为实施例7的膜片的修复效果图，其余实验组效果与实施例7类似，不再列举)。对照组膜片表面可见丰富毛细血管，新生组织长入旺盛，增生过快，膜片变形严重，明显增厚，如图2、图3所示。可见含有节点的膜片在促进组织长入的同时能很好控制组织生长，避免组织变形、网片皱缩及减少对周围组织影响。
实施例9无张力悬吊带***
如图14显示了一种无张力悬吊带***的实现形式，包括吊带主体1和包覆吊带主体表面的护套2和设于吊带主体两端的导引线4及用于保护导引线的套管3；所述吊带主体设置有由多个通孔11组成的镂空网格状结构，所述吊带主体为由纤维堆积增材制造技术制成的纤维层；所述通孔的边缘为弧边或直边，且当所述通孔的边缘为直边时，各直边之间圆滑过渡；所述吊带主体的边缘为弧形边缘；所述弧形边缘由多个重复排列的弧形单元12构成。每个弧形重复单元的宽度为1mm～10mm；每个弧形重复单元的间距为0mm。
所述护套2的上表面或下表面上设置有一个孔21，所述孔21的面积占其所在的护套上表面/下表面总面积的20％以上。
图15显示了另一种无张力悬吊带***的实现形式，包括吊带主体1和包覆吊带主体表面的护套2和设于吊带主体两端的导引线4及用于保护导引线的套管3；所述吊带主体设置有由多个通孔11组成的镂空网格状结构，所述吊带主体为由纤维堆积增材制造技术制成纤维层；所述通孔的边缘为弧边或直边，且当所述通孔的边缘为直边时，各直边之间圆滑过渡；所述吊带主体的边缘为弧形边缘；所述弧形边缘由多个重复排列的弧形单元12构成。每个弧形重复单元的宽度为1mm～10mm；每个弧形重复单元的间距为0mm。
所述护套2由对称分布的左护套22和右护套23组成，且左护套22和右护套23各自独立；所述左护套22和右护套23对应于吊带主体的同一面上分别设有孔221，231。孔221，231的面积占其所在的左护套上表面或右护套上表面面积的20％以上。所述左护套22与右护套23在其相邻一端存在间隙，所述间隙为0.1cm-10cm。吊带主体1的宽度为7～15mm。
图16展示了设于吊带主体上的通孔11的几种不同的形状，可以是椭圆形， 圆形或四角圆滑过渡的方形。
吊带主体1的弧形边缘12设计，如上所述可以是由多个重复排列的弧形单元12构成。每个弧形重复单元的宽度为1mm～10mm；每个弧形重复单元的间距为0mm；或者如图17所示，每个弧形重复单元的存在小于10mm的间距。
套管3的一端与吊带主体1连接，另一端呈锥体形。优选地，所述套管3的形状如图18所示，套管3包括由与吊带主体1连接的呈直管状的第一部分31及呈子弹头状的第二部分32。所述套管3的总长为5mm-20mm，优选10mm-16mm；所述第一部分31的长度为3mm～17mm，优选6mm～13mm；第一部分31的直径为2mm～8mm，优选3mm～5mm。
本实施例中，所述吊带主体为由直径在0.01μm～100μm的静电纺丝纤维制成的组织支架，所用的材料可以是聚氟类材料(PVDF、PTFE等)、聚烯烃(聚乙烯、聚丙烯等)、聚氨酯类材料(PU、PCU、TPU等)等不可降解材料。其蓬松度、稳定度不需要作额外的限制。
为了更便于医生进行手术操作，优选地，所述护套上设置有定位线。对于图14的结构，由于护套2是一体成型，优选地，所述定位线与护套在轴向上的对称线重合；更优选在定位线处设置撕裂线/裁剪线。
实施例10
本实施例所述无张力悬吊带***结构与实施例9的图14或图15所述结构相同。区别在于所用的吊带主体为由直径在0.01μm～100μm的纤维构成的组织支架，具有多孔状结构，其蓬松度为200～2000cm3/g，其纤维交接处发生融合形成纤维节点；
所述组织支架的稳定度S符合以下关系：
Figure PCTCN2015099217-appb-000005
其中T1为组织支架初始厚度，T2为力学疲劳试验后测得组织支架的厚度，厚度单位mm；S的数值为1～3。本实施例中所述的吊带主体可以采用纤维堆积增材制造技术制成，也可以参考CN104645420A中记载的制备方法制备。
据信，具有上述性能的吊带主体的具有更好的力学性能和修复性能。
对比例2
本对比例的无张力悬吊带***除护套上不设有孔(即护套的上下表面均为密闭整体)外，其余结构与实施例9的图14所述的结构相同。
阻力测试实验按照如下方法进行：
将包覆有护套的吊带主体从长25cm，厚度为8cm的瘦牛肉块中心穿过。在牛肉上放置重物，用于模拟手术过程吊带穿过人体时，肌肉及筋膜组织对吊带的压迫力。随后将吊带主体露出牛肉外的部分剪断，保持余下部分不动，缓慢牵引导引线将护套及多余的吊带主体部分抽出，读取指针式推拉力计上的力学数值，记录后按复位键归零，开始下一组测试。
取出护套的阻力测试结果如表2所示
表2
Figure PCTCN2015099217-appb-000006
从上述对比可以看出，本发明所述的结构，能够减少取出护套时所用的力。 因此更便于操作。
护套从人体组织中取出时的受力情况如图19所示。由于吊带植入过程中通常会发生折叠，因此取出过程中需要克服护套与人体组织、护套与吊带主体的多重作用力。图19a展示以具有对比例2所述的护套的受力情况。吊带在人体组织中处于折叠的状态，在C处裁断之后，取出护套时，每层护套与吊带主体的接触面都会产生摩擦力，此时，将护套往D方向抽离人体时，护套受吊带主体的摩擦力为F摩＝4μF压(式中，F摩为护套取出所受吊带主体的摩擦力，μ为摩擦系数，F压为吊带所受压力)，图19b展示以具有图14所示结构的护套的受力情况，当护套的上表面或下表面开孔后，护套在植入过程中向设有开孔的一面折叠，此时取出护套时护套受到摩擦力为F摩＝2μF压。可见，在护套的一个面上设置开孔后，护套的摩擦阻力显著减小。因此在护套的一个面上设有孔的设计能够消除吊带折叠内部的摩擦力，从而能够减少取出护套时所用的力。
实施例11无张力悬吊带***的另一种实现方式
一种无张力悬吊带***的实现形式，包括吊带主体和包覆吊带主体表面的护套，所述护套如图20所示，包括护套主体5和护套主体形成的容腔6，护套主体的一端设有容腔开口，另一端设有折叠部8，护套主体5上表面设有与容腔6相通的孔9，折叠部8朝上折叠。
实施例12
如图21和图22所示，与实施例11不同的是，孔9由中部向容腔开口处收缩，并形成所述孔9的最大受力点，所述最大受力点处设有一延伸至容腔开口的切割线7。
更具体地，所述孔9的边缘由靠近容腔开口的方向至远离容腔开口方向为依次相连的前部91、中部92、末部93；所述前部91包括第一前边缘线911和第二前边缘线912以及这两条线相交而形成的交汇点913，所述交汇点913为最大受力点，且所述交汇点913到所述容腔开口边缘的距离小于所述第一前边缘线、第二前边缘线上其它任意一点到所述容腔6的开口边缘的距离；所述交汇点913设有一延伸至容腔开口的切割线7。
所述中部92包括与第一前边缘线911相连的第一中边缘线921和与第二前边缘线912相连的第二中边缘线922。
切割线7与护套主体5的轴心线共平面，使得护套主体的断裂方向与护套取出时的受力方向相同，受力更加均匀，切割线7的深度H占其所在护套主体5的厚度值L的30～90％，优选占其所在护套主体的厚度值的50％。
孔9的总面积占其所在护套主体5的上表面51面积的50％～70％，优选占其所在护套主体5的上表面51面积的55％。
如图21和图23所示，折叠部8朝上折叠，折叠部8包括第一折叠部81、第二折叠部82、延长部83以及三者交汇的折叠处84，孔的末部93的边缘线到折叠处84的距离d为2～6cm。
其它结构及连接关系与实施例11相同。
实施例13
如图24所示,与实施例12不同的是，前部91呈半椭圆形，第一前边缘线911和第二前边缘线912以切割线7所在直线为对称轴相对称。末边缘线93呈半椭圆形，并以切割线7所在直线为对称轴相对称。
护套主体5的宽度为10～15mm。第一中边缘线921和第二中边缘线922为相互平行的直线，第一中边缘线921和第二中边缘线922以切割线7所在直线为对称轴相对称，第一中边缘线921与第二中边缘线922之间的距离为6～8mm。孔的形状呈为跑道型形状(中间为矩形、两边为半椭圆形的)。
其它结构及连接关系与实施例12相同。
实施例14
如图25所示,与实施例13不同的是，护套主体5上设有3个孔，各孔延护套主体的延伸方向整齐排列分布，相邻各孔之间也存在切割线，切割线与护套主体5的轴心线共平面。另外，最接近折叠部的孔的末部的边缘线到折叠处的距离为2～6cm。
其它结构及连接关系与实施例13相同。

Claims (40)

  1. 一种软组织修复补片，其特征在于，所述软组织修复补片为由直径在0.01μm～10μm的纤维构成的组织支架，具有多孔状结构，其蓬松度为200～2000cm3/g，其纤维交接处发生融合形成纤维节点；
    所述组织支架的稳定度S符合以下关系：
    Figure PCTCN2015099217-appb-100001
    其中T1为组织支架初始厚度，T2为力学疲劳试验后测得组织支架的厚度，厚度单位mm；S的数值为1～3。
  2. 根据权利要求1所述软组织修复补片，其特征在于，所述纤维交接处发生融合形成纤维节点为在纤维间交叉搭接处发生融合形成的微观节点或在纤维间并排接触处发生融合形成的宏观节点。
  3. 根据权利要求2所述软组织修复补片，其特征在于，所述微观节点的形状呈团状，平均直径为10nm～10μm。
  4. 根据权利要求2所述软组织修复补片，其特征在于，所述宏观节点的形状呈线状、团状，线状宏观节点的线宽为25～1000μm；团状宏观节点的平均直径为25～1000μm。
  5. 根据权利要求4所述软组织修复补片，其特征在于，所述线状宏观节点的线宽为50～500μm；团状宏观节点的直径为50～500μm。
  6. 根据权利要求1至5中任意一项所述软组织修复补片，其特征在于，所述软组织修复补片的蓬松度为600～1600cm3/g。
  7. 根据权利要求6所述软组织修复补片，其特征在于，所述软组织修复补片的柔软度为50～500毫牛顿。
  8. 根据权利要求7所述软组织修复补片，其特征在于，所述软组织修复补片的柔软度为200～450毫牛顿。
  9. 权利要求1至8任意一项所述软组织修复补片的制备方法，其特征在于，包括如下步骤：
    S1.将纤维材料与溶剂体系配置为均一溶液，得到均一的纤维材料溶液；所述溶剂由溶剂A和溶剂B组成，溶剂A与溶剂B的体积比为1:9～9:1；溶剂A的沸 点高于80℃，溶剂B的沸点低于60℃；
    S2.将步骤S1.中得到的纤维材料溶液装入静电纺丝注射器中，进行静电纺丝得到纤维丝，并将纤维丝接收为膜状结构，得到纤维膜；
    S3.将步骤S2.中得到的纤维膜经热压或冷压后热烘干，得到所述软组织修复补片；所述热压或冷压的压力范围为103Pa～106Pa；热压温度范围为50℃～300℃；冷压温度为室温。
  10. 权利要求1至8任意一项所述软组织修复补片的制备方法，其特征在于，包括如下步骤：
    S1.采用具有不同熔点的两种纤维材料分别溶于溶剂中，分别制成纤维材料溶液；
    S2.将步骤S1中得到的纤维材料溶液装入静电纺丝注射器中，进行静电纺丝得到纤维丝，并将纤维丝接收为膜状结构，得到纤维膜；
    S3.所述纤维膜在熔点较低的材料的Tm以下80℃到Tm温度的范围之间进行热压处理，得到所述软组织修复补片。
  11. 根据权利要求9或10所述软组织修复补片的制备方法，其特征在于，在步骤S2中，先对纤维丝进行定向取向，再进行余下步骤。
  12. 根据权利要求9至11中任意一项所述软组织修复补片的制备方法，其特征在于，在所有步骤完成后，再进行拉伸操作。
  13. 一种无张力悬吊带***，其特征在于，所述无张力悬吊带***包括吊带主体和包覆吊带主体表面的护套；所述吊带主体由纤维膜层构成，所述吊带主体为由多个通孔组成的镂空网格状支架结构；所述护套的上表面或下表面上设置有孔。
  14. 根据权利要求13所述无张力悬吊带***，其特征在于，所述护套上的孔的总面积占其所在的护套上表面或下表面总面积的10％以上，优选为20％～50％。
  15. 根据权利要求13所述无张力悬吊带***，所述护套包括对称分布在吊带主体左半部和右半部的第一护套和第二护套；所述第一护套和第二护套分别由吊带主体的两端向吊带主体的中央延伸，且第一护套和第二护套各自独立；所述第一护套和第二护套上的孔位于同一面。
  16. 根据权利要求15所述无张力悬吊带***，其特征在于，设于第一护套和/或第二护套上的孔的数量为1～5个。
  17. 根据权利要求15所述无张力悬吊带***，其特征在于，所述第一护套与第二护套在其相邻一端存在间隙，所述间隙为0.1cm～10cm。
  18. 根据权利要求13至17任意一项所述无张力悬吊带***，其特征在于，所述吊带主体的上表面及下表面的粗糙度均为0.1μm～50μm。
  19. 根据权利要求13至18任意一项所述无张力悬吊带***，其特征在于，所述吊带主体上的通孔的形状为圆形、椭圆形或设有倒角的多边形。
  20. 根据权利要求13至19任意一项所述无张力悬吊带***，其特征在于，所述吊带主体上的通孔的孔径为1.5～5mm。
  21. 根据权利要求13至20任意一项所述无张力悬吊带***，其特征在于，所述吊带主体上的通孔在吊带主体上的分布密度为1～10个/cm2。
  22. 根据权利要求13至21任意一项所述无张力悬吊带***，其特征在于，所述吊带主体的厚度为0.1mm～1mm。
  23. 根据权利要求13至22任意一项所述无张力悬吊带***，所述护套上设置有定位线。
  24. 根据权利要求13至23任意一项所述无张力悬吊带***，其特征在于，所述无张力悬吊带***的两端设有导引线和套管。
  25. 根据权利要求24所述无张力悬吊带***，其特征在于，所述套管的一端与护套及吊带主体连接，另一端呈锥体形；所述导引线的一端与护套及吊带主体连接，另一端穿过套管的锥体形端部的开口延伸至套管外。
  26. 根据权利要求24所述的无张力悬吊带***，所述套管的一端与护套和吊带主体连接，另一端呈子弹头形状；所述导引线的一端与护套及吊带主体连接，另一端穿过套管的子弹头形状端部的开口延伸至套管外。
  27. 根据权利要求13至26任意一项所述的无张力悬吊带***，所述吊带主体的边缘为弧形边缘，所述弧形边缘由多个重复排列的弧形单元组成；每个弧形单元的弧边的宽度为1mm～10mm，相邻两个弧形单元的间距为0mm～10mm。
  28. 根据权利要求13至27任意一项所述无张力悬吊带***，其特征在于，所述吊带主体在承受2kg重力时的伸长率为10％～50％。
  29. 根据权利要求13至28任意一项所述无张力悬吊带***，其特征在于，所述吊带主体的宽度为7～15mm。
  30. 根据权利要求13至29任意一项所述无张力悬吊带***，其特征在于，所述护套包括护套主体和护套主体形成的容腔，护套主体的一端设有容腔开口，另一端设有折叠部，所述护套主体上表面设有所述孔，所述折叠部朝上折叠。
  31. 根据权利要求30所述无张力悬吊带***，所述孔由中部向容腔开口处收缩，并形成所述孔的最大受力点，所述最大受力点处设有一延伸至容腔开口的切割线。
  32. 根据权利要求31所述无张力悬吊带***，其特征在于，所述切割线与所述护套主体的轴心线共平面。
  33. 根据权利要求31所述无张力悬吊带***，其特征在于，所述孔的边缘由靠近容腔开口的方向至远离容腔开口方向为依次相连的前部、中部、末部；所述前部包括第一前边缘线和第二前边缘线以及这两条线相交而形成的交汇点，所述交汇点为最大受力点，且所述交汇点到所述容腔开口边缘的距离小于所述第一前边缘线、第二前边缘线上其它任意一点到所述容腔的开口边缘的距离；所述交汇点设有一延伸至容腔开口的切割线。
  34. 根据权利要求33所述无张力悬吊带***，其特征在于，所述第一前边缘线和所述第二前边缘线以所述切割线与所述护套主体的轴心线所共的平面为对称面。
  35. 根据权利要求32所述无张力悬吊带***，其特征在于，所述折叠部包括第一折叠部、第二折叠部、延长部以及三者交汇的折叠处；所述孔的末部的边缘线到折叠处的距离为2～6cm。
  36. 根据权利要求33所述无张力悬吊带***，其特征在于，所述中部包括与第一前边缘线相连的第一中边缘线和与第二前边缘线相连的第二中边缘线，所述第一中边缘线和所述第二中边缘线以所述切割线与所述护套主体的轴心线所共的平面为对称面。
  37. 根据权利要求36所述无张力悬吊带***，其特征在于，所述护套主体的宽度为10～15mm，所述第一中边缘线与所述第二中边缘线之间的距离为6～11mm。
  38. 根据权利要求31至37任一项所述无张力悬吊带***，其特征在于，所述切割线的深度占其所在护套主体的厚度的30～90％。
  39. 根据权利要求13至38任一项所述无张力悬吊带***，其特征在于，所述纤维膜层为由直径在0.01μm～100μm的纤维构成的纤维膜组织支架，具有多孔状结构，其蓬松度为200～2000cm3/g，其纤维交接处发生融合形成纤维节点；
    所述组织支架的稳定度S符合以下关系：
    Figure PCTCN2015099217-appb-100002
    其中T1为组织支架初始厚度，T2为力学疲劳试验后测得组织支架的厚度，厚度单位mm；S的数值为1～3。
  40. 根据权利要求39所述无张力悬吊带***，其特征在于，所述纤维膜层为由直径在0.1μm～10μm的纤维构成的纤维膜组织支架。
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