WO2016107522A1 - Timbre de réparation de tissu mou et son procédé de préparation, et système de ceinture de suspension sans tension - Google Patents

Timbre de réparation de tissu mou et son procédé de préparation, et système de ceinture de suspension sans tension Download PDF

Info

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
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
sling
tension
fiber
soft tissue
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2015/099217
Other languages
English (en)
Chinese (zh)
Inventor
王国帅
赖奎霖
郭泽跃
袁玉宇
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medprin(shenzhen) Regenerativea Medical Technologies Co Ltd
Original Assignee
Medprin(shenzhen) Regenerativea Medical Technologies Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201410833554.XA external-priority patent/CN104645420B/zh
Priority claimed from CN201520831544.2U external-priority patent/CN205234541U/zh
Priority claimed from CN201510703366.XA external-priority patent/CN105250050B/zh
Application filed by Medprin(shenzhen) Regenerativea Medical Technologies Co Ltd filed Critical Medprin(shenzhen) Regenerativea Medical Technologies Co Ltd
Publication of WO2016107522A1 publication Critical patent/WO2016107522A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dermatology (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Textile Engineering (AREA)
  • Biomedical Technology (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un timbre de réparation de tissu mou, son procédé de préparation, et un système de ceinture de suspension sans tension ; le patch de réparation de tissu mou est un échafaudage fibreux formé par des fibres ayant des diamètres de 0,01 μm à 10 μm, et présente une structure poreuse ayant une valeur de charge de 200 à 2000 cm3/g ; et les fibres sont fusionnées ensemble pour former un nœud de fibres au niveau de la position de leur liaison. Le procédé de préparation du timbre de réparation de tissu mou consiste : à préparer un film de fibre par l'intermédiaire d'une technique de filage électrostatique ; et à traiter le film de fibre pour permettre la fusion au niveau de la position de liaison des fibres pour former le nœud de fibres. Le système de ceinture de suspension sans tension comprend un corps de ceinture de suspension et une gaine de protection recouvrant une surface du corps de ceinture de suspension ; le corps de ceinture de suspension est formé par des couches de film de fibre, et a une structure d'échafaudage de grille creuse comprenant une pluralité de trous traversants ; et un trou est ménagé dans une surface supérieure ou une surface inférieure de la gaine de protection.
PCT/CN2015/099217 2014-12-29 2015-12-28 Timbre de réparation de tissu mou et son procédé de préparation, et système de ceinture de suspension sans tension Ceased WO2016107522A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
CN201410833554.X 2014-12-29
CN201410833554.XA CN104645420B (zh) 2014-12-29 2014-12-29 一种软组织修复补片及其制备方法
CN201520831544.2U CN205234541U (zh) 2015-10-26 2015-10-26 一种软组织修复用器械的护套
CN201510703366.XA CN105250050B (zh) 2015-10-26 2015-10-26 一种无张力悬吊带系统
CN201520831544.2 2015-10-26
CN201510703366.X 2015-10-26

Publications (1)

Publication Number Publication Date
WO2016107522A1 true WO2016107522A1 (fr) 2016-07-07

Family

ID=56284271

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2015/099217 Ceased WO2016107522A1 (fr) 2014-12-29 2015-12-28 Timbre de réparation de tissu mou et son procédé de préparation, et système de ceinture de suspension sans tension

Country Status (1)

Country Link
WO (1) WO2016107522A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114177364A (zh) * 2021-12-17 2022-03-15 无锡中科光远生物材料有限公司 软组织增强膜材料及其制备方法和应用
CN114681671A (zh) * 2020-12-30 2022-07-01 广州迈普再生医学科技股份有限公司 组织修复膜
US20220341071A1 (en) * 2021-04-23 2022-10-27 Panasonic Intellectual Property Management Co., Ltd. Fiber assembly and method for producing fiber assembly

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101705593A (zh) * 2009-10-29 2010-05-12 无锡中科光远生物材料有限公司 一种超细纤维膜的定型方法
CN103079495A (zh) * 2010-08-26 2013-05-01 伊西康公司 用于可植入吊带的定心辅助件
CN103800096A (zh) * 2012-11-14 2014-05-21 深圳迈普再生医学科技有限公司 骨盆底功能障碍性疾病修复用植入纤维膜片、制备方法及含有其的医疗器械
US20140277576A1 (en) * 2013-03-14 2014-09-18 Ethicon, Inc. Randomly Uniform Three Dimensional Tissue Scaffold of Absorbable and Non-Absorbable Materials
CN104645420A (zh) * 2014-12-29 2015-05-27 深圳迈普再生医学科技有限公司 一种软组织修复补片及其制备方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101705593A (zh) * 2009-10-29 2010-05-12 无锡中科光远生物材料有限公司 一种超细纤维膜的定型方法
CN103079495A (zh) * 2010-08-26 2013-05-01 伊西康公司 用于可植入吊带的定心辅助件
CN103800096A (zh) * 2012-11-14 2014-05-21 深圳迈普再生医学科技有限公司 骨盆底功能障碍性疾病修复用植入纤维膜片、制备方法及含有其的医疗器械
US20140277576A1 (en) * 2013-03-14 2014-09-18 Ethicon, Inc. Randomly Uniform Three Dimensional Tissue Scaffold of Absorbable and Non-Absorbable Materials
CN104645420A (zh) * 2014-12-29 2015-05-27 深圳迈普再生医学科技有限公司 一种软组织修复补片及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
LIU, YANBO: "Enhanced Self-Bonding Blending Electrospun Nanofiber Membrane", POLYMER BULLETIN., 30 November 2014 (2014-11-30) *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114681671A (zh) * 2020-12-30 2022-07-01 广州迈普再生医学科技股份有限公司 组织修复膜
CN114681671B (zh) * 2020-12-30 2024-11-29 广州迈普再生医学科技股份有限公司 组织修复膜
US20220341071A1 (en) * 2021-04-23 2022-10-27 Panasonic Intellectual Property Management Co., Ltd. Fiber assembly and method for producing fiber assembly
US12215448B2 (en) * 2021-04-23 2025-02-04 Panasonic Intellectual Property Management Co., Ltd. Fiber assembly and method for producing fiber assembly
CN114177364A (zh) * 2021-12-17 2022-03-15 无锡中科光远生物材料有限公司 软组织增强膜材料及其制备方法和应用

Similar Documents

Publication Publication Date Title
CN103800096B (zh) 骨盆底功能障碍性疾病修复用植入纤维膜片、制备方法及含有其的医疗器械
CN103800097B (zh) 一种组织修复用纤维膜及其制造方法和应用
EP3375461B1 (fr) Membrane à fibre de réparation tissulaire, son procédé de préparation et application, et produit de réparation tissulaire
Panseri et al. Electrospun micro-and nanofiber tubes for functional nervous regeneration in sciatic nerve transections
KR101853283B1 (ko) 조직 복구용 섬유막 및 그 제품 및 제조 방법
CA2829881C (fr) Systeme d'echafaudage pour la reparation d'etats cardiovasculaires
AU2019201236A1 (en) Electrospun biocompatible fiber compositions
CN103800942B (zh) 骨盆底修补片
JP2011115618A (ja) メッシュインプラント
CN107636220B (zh) 一种增强电纺纤维膜及其制备方法
US9744016B2 (en) Incontinence treatment device
CN115364283A (zh) 一种仿生界面多层复合神经支架及其制备方法与应用
WO2016107522A1 (fr) Timbre de réparation de tissu mou et son procédé de préparation, et système de ceinture de suspension sans tension
WO2013005004A1 (fr) Conduit de drainage de petit diamètre implantable
CN110891619A (zh) 含丝心蛋白的纤维聚合物材料以及包含其的聚合物支架
BOWEN et al. A silicone rubber tendon for extraocular muscle: An experimental study
CN105250050B (zh) 一种无张力悬吊带系统
CN116421782B (zh) 具有促进神经修复功能的聚氨基酸复合材料及其制备方法和应用
CN215739666U (zh) 一种用于额肌悬吊术中的悬吊线
KR20250113945A (ko) 복합 소재를 포함하는 요실금 치료용 인체 이식 장치
Kodama et al. Carbon-nanotube yarns induce axonal regeneration in peripheral nerve defect
RU2446749C2 (ru) Протез барабанной перепонки
El-Ghannam Control Testing and Effect of Manufacturing Parameters on the Biocompatibility of Polypropylene Mesh Implants

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 15875198

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 15875198

Country of ref document: EP

Kind code of ref document: A1