US20070219568A1 - Monofilament, Surgical Mesh Having Improved Flexibility and Biocompatibility, and Process for Preparing the Same - Google Patents

Monofilament, Surgical Mesh Having Improved Flexibility and Biocompatibility, and Process for Preparing the Same Download PDF

Info

Publication number
US20070219568A1
US20070219568A1 US11/568,251 US56825105A US2007219568A1 US 20070219568 A1 US20070219568 A1 US 20070219568A1 US 56825105 A US56825105 A US 56825105A US 2007219568 A1 US2007219568 A1 US 2007219568A1
Authority
US
United States
Prior art keywords
degradable polymer
monofilament
mesh
degradable
hernia mesh
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.)
Abandoned
Application number
US11/568,251
Other languages
English (en)
Inventor
Guw-Dong Yeo
Jun-Bae Kim
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.)
Samyang Biopharmaceuticals Corp
Original Assignee
Samyang Corp
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
Application filed by Samyang Corp filed Critical Samyang Corp
Publication of US20070219568A1 publication Critical patent/US20070219568A1/en
Assigned to SAMYANG CORPORATION reassignment SAMYANG CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LEE, JAE-HONG
Assigned to SAMYANG BIOPHARMACEUTICALS CORPORATION reassignment SAMYANG BIOPHARMACEUTICALS CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SAMYANG CORPORATION
Abandoned legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • 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
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings
    • 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
    • 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
    • A61L31/041—Mixtures of macromolecular compounds
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146—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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/001—Combinations of extrusion moulding with other shaping operations
    • B29C48/0018—Combinations of extrusion moulding with other shaping operations combined with shaping by orienting, stretching or shrinking, e.g. film blowing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/05—Filamentary, e.g. strands
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/30—Extrusion nozzles or dies
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/30—Extrusion nozzles or dies
    • B29C48/345—Extrusion nozzles comprising two or more adjacently arranged ports, for simultaneously extruding multiple strands, e.g. for pelletising
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/92—Measuring, controlling or regulating
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D10/00—Physical treatment of artificial filaments or the like during manufacture, i.e. during a continuous production process before the filaments have been collected
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D10/00—Physical treatment of artificial filaments or the like during manufacture, i.e. during a continuous production process before the filaments have been collected
    • D01D10/02—Heat treatment
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/08—Melt spinning methods
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/08—Melt spinning methods
    • D01D5/088—Cooling filaments, threads or the like, leaving the spinnerettes
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/08—Melt spinning methods
    • D01D5/088—Cooling filaments, threads or the like, leaving the spinnerettes
    • D01D5/0885—Cooling filaments, threads or the like, leaving the spinnerettes by means of a liquid
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/12—Stretch-spinning methods
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/12—Stretch-spinning methods
    • D01D5/16—Stretch-spinning methods using rollers, or like mechanical devices, e.g. snubbing pins
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/28—Formation of filaments, threads, or the like while mixing different spinning solutions or melts during the spinning operation; Spinnerette packs therefor
    • D01D5/30—Conjugate filaments; Spinnerette packs therefor
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/28—Formation of filaments, threads, or the like while mixing different spinning solutions or melts during the spinning operation; Spinnerette packs therefor
    • D01D5/30—Conjugate filaments; Spinnerette packs therefor
    • D01D5/32—Side-by-side structure; Spinnerette packs therefor
    • D—TEXTILES; PAPER
    • D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
    • D02G—CRIMPING OR CURLING FIBRES, FILAMENTS, THREADS, OR YARNS; YARNS OR THREADS
    • D02G3/00—Yarns or threads, e.g. fancy yarns; Processes or apparatus for the production thereof, not otherwise provided for
    • D02G3/44—Yarns or threads characterised by the purpose for which they are designed
    • D02G3/448—Yarns or threads for use in medical applications
    • D—TEXTILES; PAPER
    • D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
    • D02J—FINISHING OR DRESSING OF FILAMENTS, YARNS, THREADS, CORDS, ROPES OR THE LIKE
    • D02J1/00—Modifying the structure or properties resulting from a particular structure; Modifying, retaining, or restoring the physical form or cross-sectional shape, e.g. by use of dies or squeeze rollers
    • D02J1/22—Stretching or tensioning, shrinking or relaxing, e.g. by use of overfeed and underfeed apparatus, or preventing stretch
    • D—TEXTILES; PAPER
    • D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
    • D02J—FINISHING OR DRESSING OF FILAMENTS, YARNS, THREADS, CORDS, ROPES OR THE LIKE
    • D02J1/00—Modifying the structure or properties resulting from a particular structure; Modifying, retaining, or restoring the physical form or cross-sectional shape, e.g. by use of dies or squeeze rollers
    • D02J1/22—Stretching or tensioning, shrinking or relaxing, e.g. by use of overfeed and underfeed apparatus, or preventing stretch
    • D02J1/228—Stretching in two or more steps, with or without intermediate steps
    • D—TEXTILES; PAPER
    • D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
    • D02J—FINISHING OR DRESSING OF FILAMENTS, YARNS, THREADS, CORDS, ROPES OR THE LIKE
    • D02J1/00—Modifying the structure or properties resulting from a particular structure; Modifying, retaining, or restoring the physical form or cross-sectional shape, e.g. by use of dies or squeeze rollers
    • D02J1/22—Stretching or tensioning, shrinking or relaxing, e.g. by use of overfeed and underfeed apparatus, or preventing stretch
    • D02J1/229—Relaxing
    • D—TEXTILES; PAPER
    • D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
    • D02J—FINISHING OR DRESSING OF FILAMENTS, YARNS, THREADS, CORDS, ROPES OR THE LIKE
    • D02J13/00—Heating or cooling the yarn, thread, cord, rope, or the like, not specific to any one of the processes provided for in this subclass
    • D—TEXTILES; PAPER
    • D03—WEAVING
    • D03D—WOVEN FABRICS; METHODS OF WEAVING; LOOMS
    • D03D7/00—Woven fabrics designed to be resilient, i.e. to recover from compressive stress
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B1/00—Weft knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B1/22—Weft knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes specially adapted for knitting goods of particular configuration
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B21/00—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B21/10—Open-work fabrics
    • D04B21/12—Open-work fabrics characterised by thread material
    • 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
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A61F2240/002—Designing or making customized prostheses
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
    • A61F2250/0031—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C2948/00—Indexing scheme relating to extrusion moulding
    • B29C2948/92—Measuring, controlling or regulating
    • B29C2948/92504—Controlled parameter
    • B29C2948/92695—Viscosity; Melt flow index [MFI]; Molecular weight
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
    • B29K2023/10—Polymers of propylene
    • B29K2023/12—PP, i.e. polypropylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2067/00—Use of polyesters or derivatives thereof, as moulding material
    • B29K2067/04—Polyesters derived from hydroxycarboxylic acids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037—Other properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2028/00—Nets or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7546—Surgical equipment
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2401/00—Physical properties
    • D10B2401/12—Physical properties biodegradable
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene
    • D10B2509/08—Hernia repair mesh

Definitions

  • the present invention relates to a monofilament having a segmented pie structure formed by conjugated spinning of degradable polymers and non-degradable polymers, a hernia mesh comprising the monofilament having improved flexibility and biocompatibility, and a method for preparing the same. More specifically, the present invention relates to a monofilament prepared by conjugated spinning of degradable polymers and non-degradable polymers in the form of a segmented pie; a hernia mesh that is prepared with the monofilament and that is controlled to be gradually degraded in the body while losing the stiffness of the early stage, causing no misfeelings, and having improved flexibility and biocompatibility; and a method of preparation thereof.
  • Tension-free hernioplasty (Lichtenstein I L, Am J Surg 1989; 157; 188-193) is considered to be a useful method for reparation of hernias, because the relapse ratio thereafter is low, the operative time is short, and the operative wound heals quickly, and thereby the patient can rapidly return to normal life.
  • the mesh used for hernia repair is required to have the capability of maintaining its chemical and physical properties for several years to strengthen the peritoneum, polypropylene monofilaments have been used as the material for a hernia mesh.
  • the hernia mesh needs stiffness in order to be positioned and fixed on the surgical wound region when performing the surgical operation.
  • several methods to prepare the hernia mesh using fibers in the monofilament form have been known.
  • U.S. Pat. No. 4,347,847, U.S. Pat. No. 4,452,245, U.S. Pat. No. 5,569,273, and U.S. Pat. No. 6,287,316 disclose a method to prepare a hernia mesh consisting of polypropylene monofilaments.
  • polypropylene is non-degradable, after performing the surgical operation using the hernia mesh, the strength and stiffness of the mesh that are necessary during the initial stage after the surgical operation are continuously maintained in the body.
  • U.S. Pat. No. 5,292,328 discloses a method of preparing a hernia mesh consisting of polypropylene multifilaments in order to improve the flexibility, in which the mesh has a somewhat improved initial flexibility compared with that consisting of the monofilaments.
  • the mesh consists of only non-degradable materials, there are also some problems in that the initial strength and stiffness of the mesh are continuously maintained in the body, and an excessive amount of polypropylene remains in the body.
  • 6,287,316 discloses a method of preparing a mesh using a multifilament consisting of degradable materials and non-degradable materials.
  • the meshes prepared by the above methods consist of several threads of degradable and non-degradable materials in the combined form, there is a possibility of bacterial infection within the spaces between the threads, which is an inherent defect of multifilaments.
  • the methods employ the multifilament form wherein several strands of fiber are combined, the amount of materials required for exhibiting the necessary stiffness is larger than the case of using the monofilament.
  • the multifilament causes a strong foreign body response due to the large surface area (Beets G L, “Foreign body reactions to monofilament and braided polypropylene mesh used as preperitoneal implants in pigs”. Eur J Surg 1996; 162:823-825).
  • hernia mesh As known from the above prior art, although the use of a hernia mesh has been regarded as a basic means in performing hernia repairs, there are unsatisfactory results obtained from the studies to develop a hernia mesh for improving the convenience in performing the operation, reducing the misfeelings, and having improved biocompatibility. Therefore, it is required to develop a hernia mesh that can maintain its strength and stiffness at the early stage, thereby ensuring convenience in performing the operation, and be partially degraded as the surgical wound is healed, thereby improving the flexibility of the remaining mesh.
  • the object of the present invention is to provide a monofilament having a segmented pie structure formed by conjugated spinning of degradable polymers and non-degradable polymers.
  • Another object of the present invention is to provide a hernia surgical mesh comprising the monofilament, having improved flexibility and biocompatibility.
  • Another object of the present invention is to provide a method of preparing the hernia mesh.
  • FIG. 1 A is an optical microscopic image of a cross section of the conjugated filament in the segmented pie form according to the present invention [1: degradable polymer, 2: non-degradable polymer].
  • FIG. 1B is a SEM (scanning electron microscope) image of the cross section of the conjugated filament in the segmented pie form according to the present invention.
  • FIG. 2A is a SEM image prior to degradation of the mesh prepared with the monofilament obtained by conjugated spinning.
  • FIG. 2B is a SEM image after degradation of the mesh prepared with the monofilament obtained by conjugated spinning.
  • FIG. 3A is a SEM image of the cross section of the monofilament prepared by conjugated spinning using 75 volume % of degradable materials.
  • FIG. 3B is a SEM image showing a distortion of the monofilament in the segmented pie form when the difference between the melt indexes is more than 14 in conjugated spinning.
  • FIG. 3C is an SEM image showing fiber separation when the stress-relaxation is not performed under the drawing conditions in conjugated spinning.
  • FIG. 4 is a schematic diagram showing the flow of two polymers at a distributing plate and a nozzle in the conjugated spinning apparatus for preparing the monofilament in the segmented pie form.
  • the present inventors have conducted continued studies to develop a novel hernia mesh with partial degradability, which maintains its strength and stiffness at the early stage to secure convenience in performing a surgical operation and then becomes partially degraded during healing of the surgical wound to increase the flexibility of the mesh remaining in the body, resulting in alleviating the patient's pain and improving the biocompatibility by remarkably reducing the amount of non-degradable materials used.
  • the present inventors found that when preparing a monofilament in the segmented pie form by conjugated spinning of degradable polymers and non-degradable polymers, the strength and stiffness necessary for the early stage of the surgical operation can be achieved by the stiffness characteristic of the monofilament itself, and after performing the operation, the monofilament becomes partially degraded in the body, and thereby the mesh consisting thereof can remain in the body in the more flexible structure, to complete the present invention.
  • the present invention relates to a hernia mesh with improved flexibility and biocompatibility and a preparation method thereof, wherein the mesh comprises monofilaments having the segmented pie structure formed by conjugated spinning of degradable polymers and non-degradable polymers, being controlled to be gradually degraded in the body, to remove the initial stiffness of the mesh and to avoid misfeelings due to the remaining mesh.
  • the monofilament in the segmented pie form which composes the hernia mesh of the present invention, consists of a degradable polymer and a non-degradable polymer, wherein the non-degradable polymer (2) is separated into several partitions by the degradable polymer (1), and the degradable polymer (1) has a continuous form [see FIG. 1A ].
  • the monofilament in the segmented pie form of the present invention is present in the monofilament form before degradation, and then, as the degradable polymer becomes degraded, the monofilament is divided into individual strands as a multifilament form, to exhibit improved flexibility.
  • the degradable polymer used in the present invention may be a homopolymer or a copolymer comprising one or more selected from the group consisting of glycolide, glycolic acid, lactide, lactic acid, caprolactone ( ⁇ -caprolactone), dioxanone (p-dioxanone), trimethylenecarbonate, polyanhydride, and polyhydroxyalkanoate, and is more preferably a glycolide/caprolactone copolymer or a dioxanone/trimethylenecarbonate/caprolactone copolymer.
  • the non-degradable polymer used in the present invention may be selected from the group consisting of polyolefins such as polypropylene, polyethylene, and a copolymer of propylene and ethylene; polyamides such as nylon 6 and nylon 66; polyurethanes; and fluoropolymers such as polyvinylidene fluoride, and is more preferably polypropylene or a copolymer of propylene and ethylene.
  • the content of the degradable polymer is preferably 30 to 70 vol % and the content of the non-degradable polymer is preferably 30 to 70 vol %, and more preferably, the content of the degradable polymer is 40 to 60 vol % and the content of the non-degradable polymer is 40 to 60 vol %.
  • the content of the degradable polymer is less than 30 vol %, in spinning, the volume of the degradable polymer is too small to separate the non-degradable polymer, and thus the non-degradable polymer is in the continuously linked form.
  • the monofilament may be prepared in a sea/islands type wherein the non-degradable polymer is surrounded by the degradable polymer as shown in FIG. 3A .
  • the monofilament prepared by conjugated spinning may be divided into several types, such as sea/islands type, a segmented pie type, a side-by-side type, a sheath/core type, and the like, depending on the structures, and the preferable type in the present invention is the segmented pie type.
  • the segmented pie type has some advantages in that the degradable materials and the non-degradable materials are uniformly spread on the surface of the fibers to attain the mobility of the peritoneum by an appropriate combination of fat tissue formed around the degradable material and connective tissue appeared around the non-degradable material, and to improve the adhesive property between the mesh and the tissues.
  • the segmented pie type monofilament can connect with the tissues in the body at the early stage after the surgical operation, and thus induce strong adhesion between the mesh and the tissues shortly after performing the surgical operation [U. Klinge, “Influence of polyglactin-coating on functional and morphological parameters of polypropylene-mesh modifications for abdominal wall repair”, Biomaterials 1999;20:613-623, U. Klinge, “Foreign body reaction to meshes used for the repair of abdominal wall” Hernias, Eur J Surg, 1999;1 65:665-673].
  • the non-degradable polymer In mesh prepared with the segmented pie type monofilament, in order to reduce the stiffness after healing of the surgical wound to less than 70% of the initial stiffness and to improve the flexibility of the mesh, it is preferable to divide the non-degradable polymer into at least four strands, and more preferably 6 to 10 strands.
  • the sea or sheath which is an outside component of the monofilament must be composed of the degradable polymer, and the island or core which is an inside component of the monofilament must be composed of the non-degradable polymer.
  • the degradable polymer located at the outside of the monofilament is degraded and dispersed, the monofilament starts exhibiting an excessive surface area and excessive fibrosis (capsule formation) occurs, whereby the strong adhesion between the mesh and the tissues in the body is inhibited.
  • the non-degradable polymer causes an inflammatory response, and rigid connective tissue is formed around the mesh, inhibiting the mobility of the peritoneum.
  • These types are unsuitable for the object of the present invention which is to improve the flexibility of the peritoneum, and are difficult to prepare with two components having different melting behaviors and different thermal contractibility.
  • the two components since the two components have the same diameter, the diameter of the remaining non-degradable fiber increases, and thereby there is a limitation in improving the flexibility of the remaining mesh.
  • the diameter of the monofilament may be controlled so as to have the strength and/or stiffness necessary at the early stage after performing the surgical operation, and at the same time to prevent a large amount of the non-degradable polymer from remaining in the body, thereby improving the biocompatibility and the flexibility. That is, in order to maintain the initial strength and stiffness, it is required for the fiber to have a density and diameter of a certain degree or higher, while in order to minimize a foreign body response when inserted in the body, it is required that the total amount of fibers used is minimized.
  • the diameter of the monofilament is preferably 100 to 250 ⁇ m.
  • the mesh of the present invention may be prepared in various shapes, and is preferably prepared as a net-structure such as a square, hexagonal, or network shape.
  • the density of the mesh is preferably 8 to 20 gauges/inch based on the distance between the needles in a flat warp knitting machine.
  • the pore size of the mesh may be 0.1 to 4.0 mm, preferably 2.0 to 3.0 mm, and the thickness of the mesh may be 200 to 800 ⁇ m, preferably 500 to 600 ⁇ m.
  • the non-degradable polymer is partitioned by the degradable polymer, and that the degradable polymer is continuously linked.
  • the present invention provides a method of preparing the monofilament in the segmented pie structure formed by conjugated spinning of the degradable polymer and the non-degradable polymer.
  • any conventional conjugated spinning apparatus may be used.
  • the polymers are melted by two extruding apparatuses for conjugated spinning. Each of the melted polymers is discharged in a desired amount through each quantitative pump to control the content ratio of each component.
  • the polymers that are melted and passed through the quantitative pump are subjected to conjugated spinning into one strand of fiber through a conjugated spinning block.
  • FIG. 4 is a schematic diagram of the preparation of the monofilament in the segmented pie form, showing the flows of the degradable polymer (3) and the non-degradable polymer (4) in the conjugated spinning block.
  • the melted polymer discharged from each quantitative pump is gathered at the distributing plate (5) in the conjugated spinning block, and passed through the nozzle to prepare the monofilament in the segmented pie form.
  • the strand obtained by conjugated spinning is solidified and crystallized in a cooling bath.
  • the air gap between the spinnerette and the surface of water in the cooing bath is preferably 0.5 to 100 cm, and more preferably 1 to 30 cm.
  • the solidified fiber is drawn through a multi-stage drawing apparatus and wound in a winder in order to obtain an improvement of the property by orientation.
  • a preferable embodiment of the monofilament in the segmented pie form is shown in FIG. 1A .
  • the melt indexes (MI) of the two polymers and the spinning conditions have to be exactly controlled.
  • the melt index of the degradable polymer may not be lower than that of the non-degradable polymer to maintain the segmented pie structure, and the difference between the melt indexes of the degradable polymer and the non-degradable polymer is preferably 10 or less. If the melt index of the degradable polymer is lower than that of the non-degradable polymer, the segmented pie structure may be obtained in a distorted and unequal form wherein the distribution of the non-degradable polymer is not equally distributed, being concentrated on a certain position as shown in FIG. 3B .
  • the melt index of the degradable polymer is not lower than that of the non-degradable polymer, and that the difference between the melt indexes of the two polymers is 10 or less.
  • the monofilament in the segmented pie form is prepared by conjugated spinning of two polymers having different properties such as the melting point, the degree of crystallinity, the thermal contractibility and the like
  • improper drawing conditions cause curling and phase separation of the two components as shown in FIG. 3C .
  • the spinning temperature is controlled within a certain range so that the melt index of the degradable polymer is the same as or higher than that of the non-degradable polymer, to allow the melting behavior of the two polymers to form the symmetric structure of the segmented pie form.
  • stress relaxation at least 10% and preferably 10 to 20% is applied in consideration of the thermal contraction rate of the two polymer components to stabilize the structure.
  • the mesh fibers may be dyed at regular intervals.
  • the dye it is preferable to dye only the degradable polymer part. Any dye that is conventionally employed in preparing sutures, such as D&C violet No.2, D&C Green No.6, FD&C Blue No.2, and the like, may be used.
  • the present invention also provides a method for preparing a mesh using the above monofilament in the segmented pie form.
  • the mesh may be prepared through three conventional steps of warping, knitting, and curing.
  • the warping step several strands are regularly wound on a beam with a constant tension to equally supply a regular amount of fiber before the knitting step.
  • the beam is equipped in a flat warp knitting machine to prepare a mesh.
  • the mesh may be prepared by a Tricot flat warp knitting machine or a Raschel flat warp knitting machine.
  • the texture and shape may be controlled so as to give the mesh the necessary strength and stiffness at the early stage and to simultaneously prevent the non-degradable materials from remaining in the body in a large amount to improve the biocompatibility and flexibility, controlling the strength and stiffness of the texture of the mesh.
  • the prepared mesh is cured to fix the shape of the mesh.
  • the curing step is performed under temperature and time conditions such that yellowing and a change of the properties are avoided.
  • the mesh is cured at a temperature 10° C. to 15° C. lower than the melting point of the component constituting the mesh, e.g., at 90° C. to 160° C., for 1 to 30 minutes.
  • the curing temperature of the mesh is determined on the basis of the melting point of polypropylene, that is, the mesh may be cured at 100 to 155° C. for 3 to 20 minutes.
  • a mesh having the following texture may be used by a flat warp knitting machine.
  • FIG. 2A is an electronic microscopy image of the mesh according to the present invention before degradation
  • FIG. 2B is that after degradation, showing that the component constituting the mesh has the monofilament form prior to degradation, and is converted to the multifilament form of several strands of the non-degradable polymer after degradation.
  • the mesh is prepared with the monofilament in the segmented pie form wherein the degradable polymer and the non-degradable polymer are repeatedly and alternatively distributed in all directions throughout the whole fiber, to improve the biocompatibility and the adhesive strength to the tissue in the body at the early stage after performing the surgical operation. Further, the stiffness after degradation is reduced by at least 70% compared with that before degradation, to maximize the flexibility of the mesh remaining in the body after the surgical wound is healed. Compared with the conventional mesh that contains only non-degradable components or partially degradable components, in the present invention the initial and remaining amounts of the non-degradable components in the mesh are lowered, and simultaneously the biocompatibility and the flexibility of the mesh are improved.
  • the mesh according to the present invention is suitable for hernia repair, since the mesh maintains the strength and the stiffness to attain the convenience of the surgical operation at the early stage, and is partially degraded to improve the flexibility as the surgical wound is healed.
  • the monofilament with the segmented pie structure formed by conjugated spinning of the degradable polymer and the non-degradable polymer may be applied to not only hernia mesh, but also to other operations, such as vaginal sling procedures, artificial ligament and tendon operations, fascial deficiencies which require the add an reinforcing material or a bridging material, and the like.
  • the monofilament in the segmented pie form was prepared through conjugated spinning of 55 vol % of a glycolide (75)/caprolactone (25) copolymer as a degradable polymer and 45 vol % of polypropylene as a non-degradable polymer under the conditions shown in the following Table 1.
  • the prepared monofilament in the segmented pie form was warped with 150 yarns/7′′ beam to prepare the mesh according to the above warp knitted texture of Example 1.
  • the prepared mesh was cured at 150° C. for 5 minutes.
  • the properties of the mesh such as thickness, weight, tensile strength, and stiffness were determined according to the conventional measuring methods, and the results are shown in the following Table 6.
  • the monofilament in the segmented pie form was prepared through conjugated spinning of 55 vol % of a glycolide (75)/caprolactone (25) copolymer as a degradable polymer and 45 vol % of a propylene (97)/ethylene (3) copolymer as a non-degradable polymer under the conditions shown in the following Table 2.
  • the prepared monofilament in the segmented pie form was warped with 120 yarns/7′′ beam to prepare the mesh according to the above warp knitted texture of Example 2.
  • the prepared mesh was cured at 155° C. for 3 minutes.
  • the properties of the mesh such as thickness, weight, tensile strength, and stiffness were determined according to the conventional measuring methods, and the results are shown in the following Table 6.
  • the monofilament in the segmented pie form was prepared through conjugated spinning of 55 vol % of a dioxanone (90)/trimethylenecarbonate (9)/caprolactone (1) tri-block copolymer as a degradable polymer and 45 vol % of polypropylene as a non-degradable polymer under the conditions shown in the following Table 3.
  • the prepared monofilament in the segmented pie form was warped with 120 yarns/7′′ beam to prepare the mesh according to the above warp knitted texture of Example 3.
  • the prepared mesh was cured at 95° C. for 10 minutes.
  • the properties of the mesh such as thickness, weight, tensile strength, and stiffness were determined according to the conventional measuring methods, and the results are shown in the following Table 6.
  • the mesh was prepared by the same method as in Example 1, except that the number of the segments of the non-degradable polymer was 8.
  • the properties of the prepared mesh such as thickness, weight, tensile strength, and stiffness were determined according to the conventional measuring methods, and the results are shown in the following Table 6.
  • the mesh was prepared by the same method as in Example 1, except that the revolution speed (rpm) of the quantitative pump was 9.7 rpm for the polypropylene (50 vol %) and 4.9 rpm for the glycolide/caprolactone copolymer (50 vol %).
  • the properties of the prepared mesh such as thickness, weight, tensile strength, and stiffness were determined according to the conventional measuring methods, and the results are shown in the following Table 6.
  • the mesh was prepared by the same method as in Example 1, except that the revolution speed (rpm) of the quantitative pump as 9.6 rpm for the polypropylene (40 vol %) and 7.2 rpm for the glycolide/caprolactone copolymer (60 vol %).
  • the properties of the prepared mesh such as thickness, weight, tensile strength, and stiffness were determined according to the conventional measuring methods, and the results are shown in the following Table 6.
  • the mesh was prepared by the same method as in Example 1, except that the revolution speed (rpm) of the quantitative pump was 4.9 rpm for the polypropylene (25 vol %) and 7.3 rpm for the glycolide/caprolactone copolymer (75 vol %).
  • the obtained monofilament was a sea/island type of monofilament wherein the polypropylene component was surrounded by the glycolide/caprolactone copolymer component as shown in FIG. 3A .
  • the mesh was prepared by the same method as in Example 1, except that the melt index of polypropylene was 27.
  • the monofilament had the segmented pie structure, but the tensile strength of the monofilament was poorer than that of Example 1, and the segmented pie structure was not symmetrical ( FIG. 3B ).
  • the mesh was prepared by the same method as in Example 1, except that the third roller velocity and the fourth roller velocity of the drawing conditions were made the same at 55 m/min such that no stress-relaxation was applied.
  • the intensity of the obtained monofilament in the segmented pie form was improved compared with that of Example 1, but strand separation of the two components occurred when preparing the mesh ( FIG. 3C ).
  • the thickness, weight, tensile strength, and stiffness of a conventional mesh product (Vypro II Hernia mesh, Ethicon Co.) comprising a glycolide/lactide copolymer multifilament as a degradable component and a polypropylene monofilament as a non-degradable component were measured according to the conventional measuring methods. The results are shown in the following Table 6.
  • Tensile 1′′ ⁇ 6′′ mesh was sampled in the horizontal and Strength vertical directions in preparing the warp knitted texture, (Kgf/inch) and the tensile strength was measured by the tensile strength tester (Instron, 4204, U.S.SA.) wherein the sample was equipped with 50 mm tensile distance and tensed at 50 mm/min. Stiffness The mesh was cut to a 1′′ ⁇ 1′′ size, to measure (mgf) the stiffness by the stiffness tester (Gurley Precision Instrument, U.S.A.) after setting the load at 5 g and the position at 2.
  • Comparative Example 1 is a case in which the content of polypropylene is 30 vol % or less, showing that the monofilament obtained by conjugated spinning does not have the segmented pie structure but rather has the sea/islands structure wherein the polypropylene component is surrounded by the glycolide/lactide copolymer component.
  • the component with the low melt index pushes the component with the high melt index to one side at the distributing plate in the spinnerette, to generate the unequal segmented pie structure.
  • the present invention provides a useful technique for preparing a mesh using a monofilament in a segmented pie structure obtained by conjugated spinning of a degradable polymer and a non-degradable polymer, to improve biocompatibility and flexibility.
US11/568,251 2004-12-29 2005-12-22 Monofilament, Surgical Mesh Having Improved Flexibility and Biocompatibility, and Process for Preparing the Same Abandoned US20070219568A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR20040115443 2004-12-29
KR10-2004-015443 2004-12-29
PCT/KR2005/004455 WO2006071023A1 (en) 2004-12-29 2005-12-22 Monofilament, surgical mesh having improved flexibility and biocompatibility, and process for preparing the same

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2005/004455 A-371-Of-International WO2006071023A1 (en) 2004-12-29 2005-12-22 Monofilament, surgical mesh having improved flexibility and biocompatibility, and process for preparing the same

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US14/849,931 Division US9883935B2 (en) 2004-12-29 2015-09-10 Process for preparing hernia mesh from monofilament

Publications (1)

Publication Number Publication Date
US20070219568A1 true US20070219568A1 (en) 2007-09-20

Family

ID=36615112

Family Applications (2)

Application Number Title Priority Date Filing Date
US11/568,251 Abandoned US20070219568A1 (en) 2004-12-29 2005-12-22 Monofilament, Surgical Mesh Having Improved Flexibility and Biocompatibility, and Process for Preparing the Same
US14/849,931 Active 2026-09-26 US9883935B2 (en) 2004-12-29 2015-09-10 Process for preparing hernia mesh from monofilament

Family Applications After (1)

Application Number Title Priority Date Filing Date
US14/849,931 Active 2026-09-26 US9883935B2 (en) 2004-12-29 2015-09-10 Process for preparing hernia mesh from monofilament

Country Status (9)

Country Link
US (2) US20070219568A1 (pt)
EP (1) EP1830734B1 (pt)
JP (1) JP4827838B2 (pt)
KR (1) KR100729415B1 (pt)
CN (1) CN100506185C (pt)
BR (1) BRPI0510336B8 (pt)
MX (1) MXPA06012475A (pt)
WO (1) WO2006071023A1 (pt)
ZA (1) ZA200608755B (pt)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090036996A1 (en) * 2007-08-03 2009-02-05 Roeber Peter J Knit PTFE Articles and Mesh
US20100198236A1 (en) * 2009-02-02 2010-08-05 Ralph Zipper Surgical Meshes and Methods of Use
WO2011115340A1 (ko) * 2010-03-17 2011-09-22 주식회사 메타바이오메드 요실금 치료용 메쉬 및 그 직조방법
WO2011118892A1 (ko) * 2010-03-23 2011-09-29 주식회사 메타바이오메드 생분해부를 가진 요실금 치료용 메쉬 및 그 직조방법
US20110301717A1 (en) * 2010-06-03 2011-12-08 Hilton Becker Supporting and Forming Transitional Material for Use in Supporting Prosthesis Devices, Implants and to Provide Structure in a Human Body
US20130211430A1 (en) * 2012-02-10 2013-08-15 Novus Scientific Pte. Ltd. Multifilaments with time-dependent characteristics, and medical products made from such multifilaments
US9113993B2 (en) 2009-11-29 2015-08-25 Jeongsam Lee Mesh patch for use in laparoscopic hernia surgery
US9468512B2 (en) 2010-10-06 2016-10-18 Astora Women's Health, Llc Implants with absorbable and non-absorbable features for the treatment of female pelvic conditions
US10022477B2 (en) 2011-12-16 2018-07-17 Samyang Biopharmaceuticals Corporation Composition for anti-adhesion, surgical mesh composite with anti-adhesion property comprising the same and method for producing thereof
CN112022424A (zh) * 2020-10-13 2020-12-04 日照天一生物医疗科技有限公司 超轻质大网孔疝修补补片及其制备方法

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100970738B1 (ko) * 2006-12-29 2010-07-16 주식회사 삼양사 중공사로 제작된 수술용 메쉬 및 이의 제조 방법
BR112012007356A2 (pt) * 2009-09-30 2016-10-04 Coloplast As tecido implantável, métodos para implementar um tecido em um corpo e para reparar um assoalho pélvico
US8734471B2 (en) 2009-10-01 2014-05-27 Coloplast A/S Method of implanting a fabric to repair a pelvic floor
DK200970135A (en) 2009-09-30 2011-03-31 Coloplast As Body implantable fabric
US9510925B2 (en) 2010-02-02 2016-12-06 Covidien Lp Surgical meshes
BR112014024153B1 (pt) * 2012-03-28 2021-09-14 Ethicon Endo-Surgery, Inc Compensador fixável a uma bigorna de um instrumento prendedor
US9090998B2 (en) * 2012-06-22 2015-07-28 Nike, Inc. Environmentally responsive fibers and garments
CN102921048B (zh) * 2012-11-09 2015-12-16 无锡中科光远生物材料有限公司 部分可吸收的纤维膜疝气补片
CN102908667B (zh) * 2012-11-09 2016-03-16 无锡中科光远生物材料有限公司 部分可吸收的纤维膜疝气补片的制备方法
CN103436988B (zh) * 2013-08-22 2015-08-12 中国纺织科学研究院 一种可部分降解的复合单丝及其制备方法
CN105483851B (zh) * 2015-11-25 2020-03-24 中国纺织科学研究院有限公司 超细聚乙交酯纤维、其机械制备方法和装置、用途、补片
CN107541842B (zh) * 2016-06-29 2020-03-24 南通纺织丝绸产业技术研究院 一种pha/pla复合纤维仿绢丝绸面料及其制备方法
CN112877795B (zh) * 2021-01-13 2022-07-29 中国水产科学研究院东海水产研究所 一种渔用聚偏二氟乙烯单丝的制备方法
KR102580214B1 (ko) * 2021-11-23 2023-09-25 주식회사 엠에이에스 미늘 봉합사 제조를 위해 비 원형 단면을 가진 채 방사되는 의료용 스레드의 제조 방법
CN114836875A (zh) * 2022-04-22 2022-08-02 无锡新宇源高分子材料科技有限公司 一种可降解亚麻合成织物的制备方法

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4652264A (en) * 1985-04-25 1987-03-24 American Cyanamid Company Prosthetic tubular article
US5292328A (en) * 1991-10-18 1994-03-08 United States Surgical Corporation Polypropylene multifilament warp knitted mesh and its use in surgery
US5395693A (en) * 1992-06-26 1995-03-07 Kolon Industries, Inc. Conjugated filament
US5480961A (en) * 1994-11-03 1996-01-02 United States Surgical Corporation Bioabsorbable polymers derived from cyclic ether esters and surgical articles made therefrom
US5593778A (en) * 1993-09-09 1997-01-14 Kanebo, Ltd. Biodegradable copolyester, molded article produced therefrom and process for producing the molded article
US6162537A (en) * 1996-11-12 2000-12-19 Solutia Inc. Implantable fibers and medical articles
US6162962A (en) * 1996-03-26 2000-12-19 Ethicon Gmbh & Co., Kg Areal implant
US6287316B1 (en) * 1999-03-26 2001-09-11 Ethicon, Inc. Knitted surgical mesh

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4769038A (en) * 1986-03-18 1988-09-06 C. R. Bard, Inc. Prostheses and techniques and repair of inguinal and femoral hernias
CA2034482C (en) * 1989-06-22 1999-01-19 Masakazu Suzuki Method for modifying medical materials of lactic acid polymers
DE3937272A1 (de) * 1989-11-09 1991-05-16 Boehringer Ingelheim Kg Neue copolymere aus trimethylencarbonat und optisch inaktiven laktiden
JP3320911B2 (ja) * 1994-07-21 2002-09-03 カネボウ株式会社 分割可能な複合繊維及びその構造物
US5569273A (en) 1995-07-13 1996-10-29 C. R. Bard, Inc. Surgical mesh fabric
JP2000054227A (ja) * 1998-07-31 2000-02-22 Unitika Ltd ポリオレフィン系複合繊維
US6667097B2 (en) * 1999-01-29 2003-12-23 Edward William Tokarsky High speed melt spinning of fluoropolymer fibers
US6045571A (en) 1999-04-14 2000-04-04 Ethicon, Inc. Multifilament surgical cord
US6548166B2 (en) * 2000-09-29 2003-04-15 E. I. Du Pont De Nemours And Company Stretchable fibers of polymers, spinnerets useful to form the fibers, and articles produced therefrom
GB0108088D0 (en) * 2001-03-30 2001-05-23 Browning Healthcare Ltd Surgical implant
DE10155842A1 (de) * 2001-11-14 2003-05-28 Ethicon Gmbh Flächiges Implantat
US7070610B2 (en) * 2002-03-30 2006-07-04 Samyang Corporation Monofilament suture and manufacturing method thereof
KR100527623B1 (ko) * 2002-06-01 2005-11-15 라이프코드인터내셔날 주식회사 세포외기질을 포함하는 인공장기 제조용 생분해성 고분자기질 및 그의 제조방법
US20030236319A1 (en) * 2002-06-25 2003-12-25 Hye-Sung Yoon Block copolymers for surgical articles
DE102004025404A1 (de) * 2004-05-24 2005-12-22 Serag-Wiessner Kg Implantat zur Suspension der Harnblase bei Harninkontinenz der Frau

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4652264A (en) * 1985-04-25 1987-03-24 American Cyanamid Company Prosthetic tubular article
US5292328A (en) * 1991-10-18 1994-03-08 United States Surgical Corporation Polypropylene multifilament warp knitted mesh and its use in surgery
US5395693A (en) * 1992-06-26 1995-03-07 Kolon Industries, Inc. Conjugated filament
US5593778A (en) * 1993-09-09 1997-01-14 Kanebo, Ltd. Biodegradable copolyester, molded article produced therefrom and process for producing the molded article
US5480961A (en) * 1994-11-03 1996-01-02 United States Surgical Corporation Bioabsorbable polymers derived from cyclic ether esters and surgical articles made therefrom
US6162962A (en) * 1996-03-26 2000-12-19 Ethicon Gmbh & Co., Kg Areal implant
US6162537A (en) * 1996-11-12 2000-12-19 Solutia Inc. Implantable fibers and medical articles
US6624097B2 (en) * 1996-11-12 2003-09-23 Solutia Inc. Implantable fibers and medical articles
US6287316B1 (en) * 1999-03-26 2001-09-11 Ethicon, Inc. Knitted surgical mesh

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090036996A1 (en) * 2007-08-03 2009-02-05 Roeber Peter J Knit PTFE Articles and Mesh
US20100198236A1 (en) * 2009-02-02 2010-08-05 Ralph Zipper Surgical Meshes and Methods of Use
US9113993B2 (en) 2009-11-29 2015-08-25 Jeongsam Lee Mesh patch for use in laparoscopic hernia surgery
WO2011115340A1 (ko) * 2010-03-17 2011-09-22 주식회사 메타바이오메드 요실금 치료용 메쉬 및 그 직조방법
WO2011118892A1 (ko) * 2010-03-23 2011-09-29 주식회사 메타바이오메드 생분해부를 가진 요실금 치료용 메쉬 및 그 직조방법
US20110301717A1 (en) * 2010-06-03 2011-12-08 Hilton Becker Supporting and Forming Transitional Material for Use in Supporting Prosthesis Devices, Implants and to Provide Structure in a Human Body
US9468512B2 (en) 2010-10-06 2016-10-18 Astora Women's Health, Llc Implants with absorbable and non-absorbable features for the treatment of female pelvic conditions
US10022477B2 (en) 2011-12-16 2018-07-17 Samyang Biopharmaceuticals Corporation Composition for anti-adhesion, surgical mesh composite with anti-adhesion property comprising the same and method for producing thereof
US9080263B2 (en) * 2012-02-10 2015-07-14 Novus Scientific Ab Multifilaments with time-dependent characteristics, and medical products made from such multifilaments
US9888992B2 (en) 2012-02-10 2018-02-13 Novus Scientific Ab Multifilaments with time-dependent characteristics, and medical products made from such multifilaments
US20130211430A1 (en) * 2012-02-10 2013-08-15 Novus Scientific Pte. Ltd. Multifilaments with time-dependent characteristics, and medical products made from such multifilaments
US10716656B2 (en) 2012-02-10 2020-07-21 Novus Scientific Ab Multifilaments with time-dependent characteristics, and medical products made from such multifilaments
CN112022424A (zh) * 2020-10-13 2020-12-04 日照天一生物医疗科技有限公司 超轻质大网孔疝修补补片及其制备方法

Also Published As

Publication number Publication date
US20150374476A1 (en) 2015-12-31
KR100729415B1 (ko) 2007-06-15
EP1830734B1 (en) 2017-03-01
BRPI0510336B8 (pt) 2021-06-22
JP2008501075A (ja) 2008-01-17
WO2006071023A1 (en) 2006-07-06
US9883935B2 (en) 2018-02-06
JP4827838B2 (ja) 2011-11-30
ZA200608755B (en) 2008-01-08
BRPI0510336A (pt) 2007-10-30
EP1830734A1 (en) 2007-09-12
MXPA06012475A (es) 2007-05-31
EP1830734A4 (en) 2014-09-17
CN100506185C (zh) 2009-07-01
BRPI0510336B1 (pt) 2018-10-09
KR20060076252A (ko) 2006-07-04
CN1950036A (zh) 2007-04-18

Similar Documents

Publication Publication Date Title
US9883935B2 (en) Process for preparing hernia mesh from monofilament
CN111419467B (zh) 聚合物网状物产品、制造方法及其用途
US20230165673A1 (en) Expandable absorbable implants for breast reconstruction and augmentation
US7070610B2 (en) Monofilament suture and manufacturing method thereof
EP1646410B1 (en) Synthetic, bioabsorbable polymer materials and implants
US20240018707A1 (en) Time-dependent synthetic biological barrier material
US20130267972A1 (en) Polymeric mesh products, method of making and use thereof
KR20190032675A (ko) 긴 분해속도를 갖는 봉합사 및 그 제조방법
KR20080058043A (ko) 모노필라멘트를 이용한 유연성 및 생체적합성이 향상된요실금 수술용 메쉬 및 이의 제조방법
KR19990010319A (ko) 강력 유지율 및 생분해성이 조절가능한 2성분계 수술용 봉합사
KR100970738B1 (ko) 중공사로 제작된 수술용 메쉬 및 이의 제조 방법
US20220192662A1 (en) Adaptive Sutures Dynamically Changing Wound Holding Properties Post-Implantation

Legal Events

Date Code Title Description
AS Assignment

Owner name: SAMYANG CORPORATION, KOREA, REPUBLIC OF

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:LEE, JAE-HONG;REEL/FRAME:019936/0219

Effective date: 20071001

AS Assignment

Owner name: SAMYANG BIOPHARMACEUTICALS CORPORATION, KOREA, REP

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SAMYANG CORPORATION;REEL/FRAME:029018/0305

Effective date: 20120917

STCB Information on status: application discontinuation

Free format text: ABANDONED -- AFTER EXAMINER'S ANSWER OR BOARD OF APPEALS DECISION