EP2018449A1 - Tissu multicouche renforce et absorbable destine a une utilisation dans des dispositifs medicaux et procede de fabrication - Google Patents

Tissu multicouche renforce et absorbable destine a une utilisation dans des dispositifs medicaux et procede de fabrication

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Publication number
EP2018449A1
EP2018449A1 EP06749638A EP06749638A EP2018449A1 EP 2018449 A1 EP2018449 A1 EP 2018449A1 EP 06749638 A EP06749638 A EP 06749638A EP 06749638 A EP06749638 A EP 06749638A EP 2018449 A1 EP2018449 A1 EP 2018449A1
Authority
EP
European Patent Office
Prior art keywords
absorbable
fabric
woven
multilayered
nonwoven fabric
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.)
Withdrawn
Application number
EP06749638A
Other languages
German (de)
English (en)
Inventor
Dhanuraj S. Shetty
Sanyog Manohar Pendharkar
Anne Jessica Gorman
Simmi Kalirai
Jerry Moore
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.)
Ethicon Inc
Original Assignee
Ethicon Inc
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 Ethicon Inc filed Critical Ethicon Inc
Publication of EP2018449A1 publication Critical patent/EP2018449A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • 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
    • 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
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/42—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties characterised by the use of certain kinds of fibres insofar as this use has no preponderant influence on the consolidation of the fleece
    • D04H1/4382—Stretched reticular film fibres; Composite fibres; Mixed fibres; Ultrafine fibres; Fibres for artificial leather
    • D04H1/43838—Ultrafine fibres, e.g. microfibres
    • 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
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L31/129—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing macromolecular fillers
    • 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
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/42—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties characterised by the use of certain kinds of fibres insofar as this use has no preponderant influence on the consolidation of the fleece
    • D04H1/4326—Condensation or reaction polymers
    • D04H1/435—Polyesters
    • 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
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/42—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties characterised by the use of certain kinds of fibres insofar as this use has no preponderant influence on the consolidation of the fleece
    • D04H1/4391—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties characterised by the use of certain kinds of fibres insofar as this use has no preponderant influence on the consolidation of the fleece characterised by the shape of the fibres
    • D04H1/43918—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties characterised by the use of certain kinds of fibres insofar as this use has no preponderant influence on the consolidation of the fleece characterised by the shape of the fibres nonlinear fibres, e.g. crimped or coiled fibres
    • 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
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/44—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling
    • D04H1/46—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling by needling or like operations to cause entanglement of fibres
    • D04H1/498—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling by needling or like operations to cause entanglement of fibres entanglement of layered webs
    • 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
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/44—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling
    • D04H1/50—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling by treatment to produce shrinking, swelling, crimping or curling of fibres
    • 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
    • D04H1/74—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 orientated, e.g. in parallel (anisotropic fleeces)
    • 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
    • D04H13/00—Other non-woven fabrics

Definitions

  • the present invention relates to a reinforced absorbable multilayered fabric that is useful in medical devices and its method of manufacture.
  • multilayered fabrics are used as all purpose pads, wound dressings, surgical meshes, including hernia repair meshes, adhesion prevention meshes and tissue reinforcement meshes, defect closure devices, and hemostats.
  • USP 5,593,441 to Lichtenstein et al describes a composite prosthesis preferably having a sheet of polypropylene mesh that allows tissue in-growth, such as Marlex® mesh.
  • This reference discloses that other surgical materials that are suitable for tissue reinforcement and defect closure may be utilized, including absorbable meshes such as a polyglactin 910 (Vicryl®) mesh.
  • the composite prosthesis of Lichtenstein et al also has an adhesion barrier, preferably a sheet of silicone elastomer.
  • USP 5,686,090 to Schilder et al describes the use of a fleece in combination with a nonabsorbable or absorbable film to prevent mis-growths to adjacent tissue and to reduce adhesions.
  • Schilder et al generally discloses that polypropylene, polyester, polyglactin, polydioxanone or poliglecaprone 25 may be used as the fleece material or the film material.
  • the term "fleece” as used in this reference is described by its porosity, which is described as being in the range between 100 and 1000 l/(m 2 s) gas flow, measured with an inlet pressure of 200 Pa, a test surface of 50 cm 2 and a test thickness of 1 mm.
  • the composite of Schilder et al is generally described as being a multilayered implant.
  • multilayered fabrics are useful for tissue engineering and orthopedic applications.
  • tissue engineering offers numerous approaches to repair and regenerate damaged/diseased tissue.
  • Tissue engineering strategies have explored the use of biomaterials that ultimately can restore or improve tissue function.
  • the use of colonizable and remodelable scaffolding materials has been studied extensively as tissue templates, conduits, barriers and reservoirs.
  • synthetic and natural materials in the form of foams, sponges, gels, hydrogels, textiles, and nonwovens have been used in vitro and in vivo to reconstruct/regenerate biological tissue, as well as deliver chemotactic agents for inducing tissue growth.
  • the different forms of scaffolds may be laminated to form a multilayered tissue engineering scaffold.
  • nonwoven fabric includes, but is not limited to, bonded fabrics, formed fabrics, or engineered fabrics, that are manufactured by processes other than weaving or knitting. More specifically, the term “nonwoven fabric” refers to a porous, textile-like material, usually in flat sheet form, composed primarily or entirely of staple fibers assembled in a web, sheet or batt. The structure of the nonwoven fabric is based on the arrangement of, for example, staple fibers that are typically arranged more or less randomly. The tensile, stress-strain and tactile properties of the nonwoven fabric ordinarily stem from fiber to fiber friction created by entanglement and reinforcement of, for example, staple fibers, and/or from adhesive, chemical or physical bonding. Notwithstanding, the raw materials used to manufacture the nonwoven fabric may be yams, scrims, netting, or filaments made by processes that include, weaving or knitting.
  • the present invention is directed to a reinforced absorbable multilayered fabric comprising a first absorbable nonwoven fabric reinforced by one or more second absorbable woven or knitted fabric, and its method of manuafacture. More particularly, the first absorbable nonwoven fabric comprises fibers comprising aliphatic polyester polymers, copolymers, or blends thereof; while the second absorbable woven or knitted fabric comprises oxidized regenerated cellulose fibers.
  • the reinforced absorbable multilayered fabric generally comprises a nonwoven fabric and one or more reinforcement fabric.
  • the reinforcement fabric provides a backing to which the nonwoven fabric may be attached, either directly or indirectly.
  • the nonwoven fabric functions as the first absorbable nonwoven fabric of the reinforced absorbable multilayered fabric described herein.
  • the first absorbable nonwoven fabric is comprised of fibers comprising aliphatic polyester polymers, copolymers, or blends thereof.
  • the aliphatic polyesters are typically synthesized in a ring opening polymerization of monomers including, but not limited to, lactic acid, lactide (including L-, D-, meso and D, L mixtures), glycolic acid, glycolide, ⁇ - caprolactone, p-dioxanone (l,4-dioxan-2-one), and trimethylene carbonate (1,3-dioxan- 2-one).
  • the first absorbable nonwoven fabric comprises a copolymer of glycolide and lactide, in an amount ranging from about 70 to 95% by molar basis of glycolide and the remainder lactide.
  • the first absorbable nonwoven fabric comprises fibers comprised of aliphatic polyester polymers, copolymers, or blends thereof, alone or in combination with oxidized polysaccharide fibers.
  • the nonwoven fabric is made by processes other than, weaving or knitting.
  • the nonwoven fabric may be prepared from yarn, scrims, netting or filaments that have been made by processes that include, weaving or knitting.
  • the yarn, scrims, netting and/or filaments are crimped to enhance entanglement with each other and attachment to the second absorbable woven or knitted fabric.
  • Such crimped yarn, scrims, netting and/or filaments may then be cut into staple that is long enough to entangle.
  • the staple may be between about 0.1 and 3.0 inches long, preferably between about 0.75 and 2.5 inches, and most preferably between about 1.5 and 2.0 inches.
  • the staple may be carded to create a nonwoven batt, which may be then needlepunched or calendared into the first absorbable nonwoven fabric. Additionally, the staple may be kinked or piled.
  • nonwoven fabrics may be utilized and include such processes as air laying, wet forming and stitch bonding. Such procedures are generally discussed in the Encyclopedia of Polymer Science and Engineering, Vol. 10, pp. 204-253 (1987) and Introduction to Nonwovens by Albin Turbank (Tappi Press, Atlanta GA 1999), both incorporated herein in their entirety by reference.
  • the thickness of the nonwoven fabric may range from about 0.25 to 2 mm.
  • the basis weight of the nonwoven fabric ranges from about 0.01 to 0.2 g/in 2 ; preferably from about 0.03 to 0.1 g/in 2 ; and most preferably from about 0.04 to 0.08 g/in 2 .
  • the weight percent of first absorbable nonwoven fabric may range from about 10 to 80 percent, based upon the total weight of the reinforced absorbable multilayered fabric.
  • the second absorbable woven or knitted fabric functions as the reinforcement fabric and comprises oxidized polysaccharides, in particular oxidized cellulose and the neutralized derivatives thereof.
  • the cellulose may be carboxylic-oxidized or aldehyde-oxidized cellulose. More preferably, oxidized regenerated polysaccharides including, but without limitation, oxidized regenerated cellulose may be used to prepare the second absorbable woven or knitted fabric. Regenerated cellulose is preferred due to its higher degree of uniformity versus cellulose that has not been regenerated.
  • Regenerated cellulose and a detailed description of how to make oxidized regenerated cellulose are set forth in USP 3,364,200, USP 5,180,398 and USP 4,626,253, the contents each of which is hereby incorporated by reference as if set forth in its entirety.
  • fabrics that may be utilized as the reinforcement fabric include, but are not limited to, Interceed ® absorbable adhesion barrier, Surgicel ® absorbable hemostat, Surgicel Nu-Knit ® absorbable hemostat and Surgicel ® Fibrillar absorbable hemostat (each available from Johnson & Johnson Wound Management Worldwide or Gynecare Worldwide, each a division of Ethicon, Inc., Somerville, New Jersey).
  • the reinforcement fabric utilized in the present invention may be woven or knitted, provided that the fabric possesses the physical properties necessary for use in contemplated applications. Such fabrics, for example, are described in USP 4,626,253, USP 5,002,551 and USP 5,007,916, the contents of which are hereby incorporated by reference herein as if set forth in its entirety.
  • the reinforcement fabric is a warp knitted tricot fabric constructed of bright rayon yarn that is subsequently oxidized to include carboxyl or aldehyde moieties in amounts effective to provide the fabrics with biodegradability.
  • the second absorbable woven or knitted fabric comprises oxidized polysaccharide fibers in combination with fibers comprised of aliphatic polyester polymers, copolymers, or blends thereof.
  • the second absorbable woven or knitted fabric preferably comprises oxidized regenerated cellulose and may have a basis weight ranging from about 0.001 to 0.2 g/in 2 , preferably in the range of about 0.01 to 0.1 g/in 2 , and most preferably in the range of about 0.04 to 0.07 g/in 2 .
  • the first absorbable nonwoven fabric is attached to the second absorbable woven or knitted fabric, either directly or indirectly.
  • the nonwoven fabric may be incorporated into the second absorbable woven or knitted fabric via needlepunching, calendaring, embossing or hydroentanglement, or chemical or thermal bonding.
  • the staple of the first absorbable nonwoven fabric may be entangled with each other and imbedded in the second absorbable woven or knitted fabric.
  • the first absorbable nonwoven fabric may be attached to the second absorbable woven or knitted fabric such that at least about 1 % of the staple of the first absorbable nonwoven fabric are exposed on the other side of the second absorbable woven or knitted fabric, preferably about 10- 20% and preferably no greater than about 50%. This ensures that the first absorbable nonwoven fabric and the second absorbable woven or knitted fabric remain joined and do not delaminate under normal handling conditions.
  • the reinforced absorbable multilayered fabric is uniform such that substantially none of the second absorbable woven or knitted fabric is visibly devoid of coverage by the first absorbable nonwoven fabric.
  • One method of making the multilayered fabric described herein is by the following process.
  • Absorbable polymer fibers having a denier per fiber of about 1 to 4 may be consolidated to about 80 to 120 denier multifilament yarn and then to about 800 to 1200 denier yarns, thermally crimped and then cut to a staple having a length between about 0.75 and 1.5 inch.
  • the staple may be fed into a multiroller dry lay carding machine one or more times and carded into a uniform nonwoven batt, while humidity is controlled between about 20-60% at a room temperature of 15 to 24 0 C.
  • the uniform nonwoven batt may be made using a single cylinder roller-top card, having a main cylinder covered by alternate rollers and stripper rolls, where the batt is doffed from the surface of the cylinder by a doffer roller and deposited on a collector roll.
  • the batt may be further processed via needlepunching or any other means such as calendaring.
  • the first absorbable nonwoven fabric may be attached to the second absorbable woven or knitted fabric by various techniques such as needlepunching.
  • the reinforced absorbable multilayered fabric may then be scoured by washing in an appropriate solvent and dried under mild conditions for 10- 30 minutes.
  • the consolidated yarns may have from about 5 to 50 crimps per inch, and preferably from about 10 to 30 crimps per inch. Efficient cutting of the crimped yarns is desirable, as any long and incompletely cut staple tends to stick on the carding machine and cause pilling.
  • a preferred range of the staple length is from about 0.75 to 2.5 inches, and more preferably from about 1.5 to 2.0 inches.
  • the relative humidity may be controlled during batt processing, preferably during carding to form the uniform nonwoven batt.
  • the nonwoven batt is processed using a dry lay carding process at a relative humidity of at least about 20% at a room temperature of about 15 to 24 0 C. More preferably, the nonwoven batt is processed at a relative humidity of from about 40% to 60%.
  • the multilayered fabric is scoured using solvents suitable to dissolve any spin finish.
  • Solvents include, but are not limited to, isopropyl alcohol, hexane, ethyl acetate, and methylene chloride.
  • the multilayered fabric is then dried under conditions to provide sufficient drying while minimizing shrinkage.
  • the reinforced absorbable multilayered fabric may have an average thickness of between about 0.5 and 3.0 mm, preferably between about 1.00 and 2.5 mm, and most preferably between about 1.2 and 2.0 mm.
  • the reported thickness is dependent upon the method of thickness measurement. Preferred methods are the ASTM methods (ASTM D5729-97 and ASTM D 1111 -6A) conventionally used for the textile industry in general and non-woven in particular. Such methods can be slightly modified and appropriately adopted in the present case as described below.
  • the basis weight of the reinforced absorbable multilayered fabric is between about 0.05 and 0.25 g/in 2 , preferably between about 0.08 and 0.2 g/in 2 , and most preferably between about 0.1 and 0.18 g/in 2 .
  • the reinforced absorbable multilayered fabric is uniform such that there is no more than about 10% variation (relative standard deviation of the mean) in the basis weight or thickness across each square inch.
  • the nonwoven fabric may comprise biologically active agents, such as hemostatic agents.
  • Hemostatic agents include, without limitation, procoagulant enzymes, proteins and peptides, either naturally occurring, recombinant, or synthetic. More specifically, prothrombin, thrombin, fibrinogen, fibrin, fibronectin, Factor X/Xa, Factor VIWHa, Factor EX/IXa, Factor XEXIa, Factor X ⁇ /XIIa, tissue factor, von Willebrand Factor, collagen, elastin, gelatin, synthetic peptides having hemostatic activity, derivatives of the above and any combination thereof, may be utilized.
  • Preferred hemostatic agents are thrombin and/or fibrinogen and fibrin.
  • the nonwoven fabric may comprise pharmacologically and biologically active agents, including but not limited to, wound healing agents, antibacterial agents, antimicrobial agents, growth factors, analgesic and anesthetic agents.
  • the reinforced absorbable multilayer fabric may be seeded or cultured with appropriate cell types prior to implantation for the targeted tissue.
  • Example 1 Nonwoven PGL fabric with ORC fabric.
  • Poly (glycolide-co-lactide) (PGL, 90/10 mol/mol) was melt-spun into fiber.
  • a multi-filament yarn was consolidated, crimped and cut into staple having a length of 1.75 inches.
  • the staple was carded to create a nonwoven batt and then compacted to a thickness of about 1.25 mm and a density of about 98.1 mg/cc.
  • the nonwoven fabric was then needlepunched into a knitted carboxylic-oxidized regenerated cellulose (ORC) fabric, available from Ethicon, Inc., under the tradename Interceed ® , to secure the nonwoven fabric to the ORC fabric.
  • ORC carboxylic-oxidized regenerated cellulose
  • Example 2 Nonwoven PGL fabric with ORC fabric.
  • Poly (glycolide-co-lactide) (PGL, 90/10 mol/mol) was melt-spun into fiber.
  • a multi-filament yarn was consolidated, crimped and cut into staple having a length of 1.75 inches.
  • the staple was carded to create a nonwoven batt and then compacted to a thickness of about 1.22 mm and a density of about 103.4 mg/cc.
  • the nonwoven fabric was then needlepunched into a knitted carboxylic-oxidized regenerated cellulose fabric (ORC), available from Ethicon, Inc., under the tradename Surgicel NuKnit ® , to secure the nonwoven fabric to the ORC fabric.
  • the final multilayered fabric comprised about 25 weight percent of the nonwoven fabric.
  • Example 3. Nonwoven PGL fabric with ORC fabric.
  • Poly (glycolide-co-lactide) (PGL, 90/10 mol/mol) was melt-spun into fiber.
  • a multi-filament yarn was consolidated, crimped and cut into staple having a length of 1.75 inches.
  • the staple was carded to create a nonwoven batt and then compacted a felt having a thickness of about 1.1 mm and a density of about 102.8 mg/cc.
  • the nonwoven fabric was then needlepunched into a knitted carboxylic-oxidized regenerated cellulose fabric (ORC), available from Ethicon, Inc., under the tradename Surgicel ® , to secure the nonwoven fabric to the ORC fabric.
  • the final multilayered fabric comprised about 60 weight percent of the nonwoven fabric.
  • Example 4 Nonwoven PGL fabric with ORC fabric.
  • Poly (glycolide-co-lactide) (PGL, 90/10 mol/mol) was melt-spun into fiber.
  • a 80 denier multifilament yarn was consolidated into a 800 denier consolidated yarn.
  • the consolidated yarn was crimped at approximately 110 0 C.
  • the crimped yarn was cut into staple having a length of about 1.25" in length.
  • 20 g of the crimped staple was accurately weighed and laid out uniformly on the feed conveyor belt of a multi-roller carding machine.
  • the environmental conditions (temp: 21 0 C /55% RH) were controlled.
  • the staple was then carded to create a nonwoven batt.
  • the batt was removed from the pick-up roller and cut into 4 equal parts.
  • the batt was weighed (19.8 g: 99% fabric yield) and then compacted into a felt.
  • the compact felt was precisely laid onto an ORC fabric and firmly attached via 2 passes in the needlepunching equipment.
  • the multilayered fabric was trimmed and scoured in 3 discrete isopropyl alcohol baths to remove spin finish and any machine oils.
  • the scoured multilayered fabric was dried in an oven at 70 0 C for 30 minutes, cooled and weighed.
  • the "thickness" of the multilayered fabric was measured as described herein.
  • the measurement tools were: (1) Mitutoyo Absolute gauge Model number ID-C125EB [Code number— 543- 452B]. The 1" diameter foot was used on the gauge.
  • the multilayered fabric was placed on a platen surface that is a smooth and machined surface.
  • the two metal plates were placed on top of each other on the multilayered fabric and gently pressed at their corners to make sure the multilayered fabric is flat.
  • the gauge foot was placed onto the top of the metal plates and was then re-lifted and re-placed, at which time a reading was made.
  • Example 5 Effect of humidity on processing of polyglactin 910 staple.
  • 80 denier polyglactin 910 consolidated yarn was crimped and cut into 1.75 inch staple. Room temperature was maintained between 21-22 0 C and the relative humidity was controlled by a room humidifier and varied from 36-60%. No additional means of static control were employed for this series of runs. Crimped staple was carded into a batt approximately 32"x8". The percent of staple incorporated into the batt after two passes through the carding machine, i.e., the yield, increased with increasing humidity, and the quality of the batt improved with yield.
  • Example 6 Effect of Staple Length on processing of polyglactin 910 staple. 80 denier polyglactin 910 consolidated yarn was crimped and cut into 1.25",
  • ⁇ Quality was rated on a scale of 1-5 based on visual inspection. 1+large areas devoid of polyglactin 910, streaking, pilling
  • Example 7 Poly (glycolide-co-lactide) (PGL, 90/10 mol/mol) was melt-spun into fiber.
  • a 80 denier multifilament yarn was consolidated into a 800 denier consolidated yarn.
  • the consolidated yarn was crimped at approximately 110 0 C.
  • the crimped yarn was cut into staple having a length of about 1.25" in length.
  • 44 g of the crimped staple was accurately weighed after conditioning the yarn for about 30 minutes in a high humidity environment (>55% RH).
  • the yarn was laid out uniformly on the feed conveyor belt of a multi-roller carding machine.
  • the feed time (5minutes) was accurately controlled to within 30-45 seconds.
  • the environmental conditions (temp: 21 0 C /25% RH) were recorded.
  • Static bars were employed near the 2 nd Randomiser roller as well as near the steel pick up roller and were turned on during the run to minimize the detrimental impact of static generation on the uniformity and yield of the resulting batt.
  • the staple was then carded to create a nonwoven batt.
  • Two vacuum inlets were strategically placed near the two edges of the 2 nd Randomizer roller to control the width of the ensuing batt.
  • the batt was removed from the pick-up roller and weighed (41g: 91% yield).
  • the uniform batt was precisely laid onto an ORC fabric and firmly attached via a single pass in the needlepunching equipment. The needle penetration depth was controlled at 12 mm.
  • the multilayered fabric was trimmed and scoured on a rack (along with other similarly produced sheets) suspended in a tank containing isopropyl alcohol to remove spin finish and any machine oils.
  • the scoured multilayered fabric (matrix sheet) was calendered to remove excess solvent and dried in an oven at 7O 0 C for app. 30 minutes, cooled and weighed.
  • Example 8 The matrix sheet as described has an off-white/beige color on both sides.
  • One side may be described as the non-woven side where as the other side as the knitted fabric side.
  • it may be vital to identify the non-woven versus knitted surfaces of the matrix. Under difficult environmental conditions, the similarity in color and texture (to some extent) makes it difficult to identify one side from the other.
  • Several means were employed to impart sidedness to the matrix sheet, which enables the observer to distinguish the 2 sides apart. These means include physical (stitching/knitting, braiding, pleating, etc), thermo-mechanical (heat, heat embossing; laser etching; etc) and chromic (use of a dye) means may be employed to achieve sidedness. The following examples describe some of the means:
  • the matrix sheet was modified on the knitted fabric side by attaching a lmm wide 4 inch long braided tape of the polyglactin 910 fiber.
  • the tapes although successful in imparting sidedness add to the amount of the longer resorbing Polyglactin 910.
  • a web made of dyed nylon fiber was placed under the knitted fabric and the non- woven batt during the needle-punching step.
  • the web is secured to the knitted fabric side due to the needling process.
  • the web affords excellent sidedness and if available in an absorbable material, could be used to make completely resorbable, implantable matrix sheets.
  • the web (mesh) can be secured similarly on the non-woven side.
  • Other means of securing the web may be thermo-mechanical in nature. Inclusion of such a web can be for the reason of mechanical enforcement as well. In such cases the web could be secured on either side or even between the two layers.
  • Such a reinforced structure may have multiple applications.
  • the small amount of Polyglactin 910 that resides on the knitted fabric side (due to the needle-punching step) of the matrix sheet can be thermally modified to create sidedness. This can include heating under pressure such that a shiny film of Polyglactin 910 is formed. Other options include heat embossing a discernible pattern. Both approaches achieve sidedness but may result in thermal degradation of the polymer/construct 8 d).
  • the knitted ORC fabric, prior to the needle-punching step is pleated (vertical or horizontal pleats). The pleats are stabilized by using heat and pressure. The pleated fabric is then used in place of the regular fabric for the rest of the process as described in Example 7. The resulting matrix sheet has distinct stripes that achieve the sidedness.
  • Dyed Polyglactin 910 creates matrix sheet that is colored on the non- woven side and off-white/beige on the other. This construct achieves sidedness.
  • a dye can be used similarly by employing a dyed suture thread etc. on the knitted side. The suture (braided into a tape or used as is) may be sewed in or thermally bonded.
  • Example 9 Rotator cuff repair using reinforced absorbable multilayered fabric.
  • the surgeon first looks at the extent of an injury using an arthroscope. Then, under general anesthesia, the patient undergoes open surgery to repair the tear.
  • a cosmetic incision is made over the top front corner of the shoulder. This incision allows access to the seam between the front and middle parts of the deltoid muscle. Splitting this seam allows access to the rotator cuff without detaching or damaging the important deltoid muscle, which is responsible for a significant portion of the shoulder's power. All scar tissue is removed from the space beneath the deltoid and the acromion (part of the shoulder blade to which the deltoid attaches). Thickened bursa and the rough edges of the rotator cuff and humerus (upper arm bone) are also smoothed to make sure that they pass smoothly beneath the acromion and deltoid.
  • edges of the cuff tendons are identified and the quality and quantity of the cuff tissue is determined.
  • the goal of the repair is to reattach good quality tendon to the location on the arm bone from which it was torn.
  • a groove or trough is fashioned in the normal attachment site for the cuff.
  • the surgeon sutures a patch of reinforced absorbable multilayered fabric into place over it. Sutures (lengths of surgical thread) draw the edge of the tendon securely into the groove to which it is to heal.
  • Example 10 Knee cartilage repair using reinforced absorbable multilayered fabric. First, the surgeon examines the knee through an arthroscope - a small device that allows the doctor to see into your knee joint. If a lesion is detected, a surgical procedure is performed.
  • the reinforced absorbable multilayered fabric is then implanted into the lesion.
  • the fabric may be attached to the lesion site with sutures, tacks, or any of a number of biocompatible glues.
  • Cartilage cells migrate into and multiply in the implanted fabric, and the cell/fabric implant intergrates with surrounding cartilage. With time, the cells will mature and fill-in the lesion with hyaline cartilage.

Abstract

La présente invention concerne un tissu multicouche comprenant un premier tissu non tissé absorbable et une second tissu tissé ou tricoté absorbable, ainsi que son procédé de fabrication.
EP06749638A 2006-04-10 2006-04-10 Tissu multicouche renforce et absorbable destine a une utilisation dans des dispositifs medicaux et procede de fabrication Withdrawn EP2018449A1 (fr)

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PCT/US2006/013284 WO2007117238A1 (fr) 2006-04-10 2006-04-10 Tissu multicouche renforce et absorbable destine a une utilisation dans des dispositifs medicaux et procede de fabrication

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JP (1) JP2009533568A (fr)
CN (1) CN101460670A (fr)
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BRPI0621587A2 (pt) 2011-12-13
AU2006341589A1 (en) 2007-10-18
JP2009533568A (ja) 2009-09-17
CA2649085A1 (fr) 2007-10-18
CN101460670A (zh) 2009-06-17
WO2007117238A1 (fr) 2007-10-18

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