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WO2007051221A1 - Substrat pour croissance de tissus - Google Patents

Substrat pour croissance de tissus Download PDF

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Publication number
WO2007051221A1
WO2007051221A1 PCT/AU2005/001697 AU2005001697W WO2007051221A1 WO 2007051221 A1 WO2007051221 A1 WO 2007051221A1 AU 2005001697 W AU2005001697 W AU 2005001697W WO 2007051221 A1 WO2007051221 A1 WO 2007051221A1
Authority
WO
WIPO (PCT)
Prior art keywords
substrate
tissue
growth
mesh
filaments
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/AU2005/001697
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English (en)
Inventor
Craig Mclachlan
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.)
Individual
Original Assignee
Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to PCT/AU2005/001697 priority Critical patent/WO2007051221A1/fr
Publication of WO2007051221A1 publication Critical patent/WO2007051221A1/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L75/00—Compositions of polyureas or polyurethanes; Compositions of derivatives of such polymers
    • C08L75/04—Polyurethanes
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • 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
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A61F2002/0086—Special surfaces of prostheses, e.g. for improving ingrowth for preferentially controlling or promoting the growth of specific types of cells or tissues

Definitions

  • the invention relates to biocompatible substrates and implantable devices for use in animals and humans which are capable of supporting tissue growth, and to methods of growing tissue using the biocompatible substrates.
  • Tissue growth is an essential part of wound healing.
  • the body is capable of efficient tissue growth to repair the wound.
  • sufficient tissue growth to repair the wound may not be possible without introducing tissue or stimulating rapid growth of the tissue.
  • the growth of tissue using the body's natural support structure is often not sufficient to ensure rapid or complete wound repair .
  • tissue either in vitro or in vivo, for use in such applications as wound repair or other applications where tissue is required.
  • Prosthetic devices have been used in the past as a support for tissue growth in treating wounds, in tissue augmentation, in repair of body organ defects, and in strengthening body cavity weaknesses. However, the ability of these prosthetic devices to support growth of tissue has been limited.
  • the invention provides a biocompatible substrate for supporting tissue growth, the substrate having a growth surface which supports tissue growth, wherein the growth surface is textured to define a plurality of growth structures, each of the growth structures comprising a continuous ridge and a well which is formed in a space defined by the ridge.
  • At least some of the ridges of adjacent growth structures may interconnect to form a network of interconnected ridges across the growth surface.
  • At least some of the ridges may include opposite upstanding walls and a bridging portion interconnecting the upstanding walls wherein at least some of the growth structures have a portion of their ridges common with an adjacent growth structure, the opposite walls of common ridges between adjacent growth structures defining part of the wells of the adjacent growth structures.
  • the upstanding walls may be vertical, or may be inclined, to define part of the wells of the adjacent growth structures.
  • the growth structures have a continuous ridge comprising interconnecting linear portions.
  • the ridge comprising interconnecting linear portions may define a space having a shape comprising, for example, three, four, five, six, seven, eight or more linear sides.
  • the shape may be, for example, triangular, trapezoid, trapezium, rectangle, rhomboid, parallelogram, pentagonal, hexagonal, septagonal or octagonal.
  • At least some of the growth structures may have a continuous ridge which comprises a curved portion.
  • the ridges comprising a curved portion may define a space having a shape that is, for example, circular, oval, elliptical, sinusoidal.
  • At least some of the growth structures may have a continuous ridge which comprises one or more linear portions and one or more curved portions.
  • a ridge may define a space having a shape that is, for example, semi-circular, sector.
  • the growth surface may be a unitary surface onto or into which the growth structures are molded or impressed.
  • the wells of at least some of the growth structures may be formed as a depression of the surface in the space defined by the continuous ridge.
  • the growth surface may comprise a base surface to which growth structures have been bonded to form the growth surface.
  • the ridges may include raised portions extending upwardly from the growth structure.
  • the raised portions may be rounded portions such as knobs which extend upwardly from the growth structure.
  • the raised portions may be elongate and have a proximal end connected to the ridge and a distal tip.
  • the distal tip may be any shape. The shape of the distal tip may be rounded, squared, pointed, hooked.
  • the wells occupy at least a substantial part of the spaces defined by continuous ridges of the growth structures.
  • the maximum width of the mouth of the well may be between any of the ranges selected from the group consisting of 0.05 to 10mm, 0.1 to 10mm, 0.15 to 10mm, 0.2 to 10mm, 0.25 to 10mm, 0.3 to 10mm, 0.4 to 9mm, 0.45 to 8mm, 0.5 to 7mm, 0.5 to 6mm, 0.5 to 5 mm, 1 to 5mm.
  • the depth of the well will vary depending on the height of the continuous ridge.
  • the maximum depth of the wells may be between any of the ranges selected from the group consisting of 0.005 to 5mm, 0.01 to 5mm, 0.015 to 5mm, 0.02 to 5mm, 0.025 to 5mm, 0.03 to 5mm, 0.04 to 4mm, 0.045 to 8mm, 0.05 to 3mm, 0.05 to lmm, 0.05 to 5 mm, 0.1 to 5mm, 0.1 to 3mm, 0.1 to 2mm, 0.1 to lmm, 0.2 to lmm, 0.25 to lmm.
  • the plurality of growth structures may be arranged in an irregular pattern.
  • the plurality of growth structures may be arranged randomly across the surface of the substrate.
  • the plurality of growth structures may be arranged in a regular pattern.
  • the regular pattern may be rows of growth structures.
  • the rows may be linear, or curved.
  • the regular pattern may be one or more concentric patterns.
  • the concentric patterns may be, for example, concentric circles, concentric squares or concentric triangles .
  • the regular pattern may be a repeated irregular pattern.
  • a portion of the plurality of growth structures may be arranged in an irregular pattern, and that irregular pattern may be repeated across the surface of the substrate to form a regular pattern across the surface of the substrate.
  • the substrate is flexible.
  • the substrate may further comprise a mesh disposed beneath the growth surface, the mesh formed from interconnected filaments which define a plurality of apertures in the mesh, wherein wells are formed in the apertures defined by the interconnected filaments.
  • the filaments may be formed from any substance suitable for forming a mesh.
  • the filaments are formed from material such as cotton, silk, linen, polyamides (polyhexamethylene adipamide (nylon 66) , polyhexamethylene sebacamide (nylon 610) , polycapramide (nylon 6) , polydodecanamide (nylon 12), polyhexamethylene isophthalamide (nylon 61) copolymers and blends thereof) , polyesters (eg. polyethylene terephthalate, polybutyl terephthalate, copolymers and blends thereof) , fluoropolymers (eg.
  • polytetrafluoroethylene and polyvinylidene fluoride polyvinylidene fluoride
  • polyolefins eg. polypropylene including isotactic and syndiotactic polypropylene and blends thereof, as well as blends composed predominantly of isotactic or syndiotactic polypropylene blended with heterotactic polypropylene (such as are described in US Pat. No.
  • the filaments of the mesh may be interconnected by any means known in the art for forming a network of interconnected filaments.
  • the filaments may be interconnected by weaving, knitting, braiding, embroidering, welding or glueing.
  • the filaments are knitted.
  • the filaments may be knitted by any methods known in the art.
  • the filaments may be knitted using a warp knit technique such as that described in "Warp Knitting Production” by Dr S. Raz, Melliand Textilberichte GmbH, Rohrbacher Str. 76, D-6900 Heidelberg, Germany (1987) .
  • the filaments are woven.
  • the filaments may be woven using techniques such as those described in Handbook of Technical Textiles, Edited by: Horrocks, A.R.; Anand, S. C. 2000; Woodhead Publishing; Hatch KL, Textile Science, New York, West Publishing Co. 1993.
  • the filaments are welded or glued.
  • the filaments may be welded by heat sealing or other methods known in the art. Methods for welding or glueing of filaments are described in, for example, Harper CA (ed) , Handbook of Plastics, Elastomers, and Composites, 2 nd Ed, New York, McGraw-Hill, 1992; Wendy Goldberg, Mary Tilley and Jim Rudolph (1997) Design solutions using microporous hydrophobic membranes, Medical Plastics and Biomaterials magazine.
  • the mesh may be a knitted surgical yarn.
  • the knitted surgical yarn may typically have from 19 to about 24 courses per inch.
  • the knitted surgical yarn may typically have from about 12 to 16 wales per inch.
  • the knitted surgical yarn may have a warp knit construction such as that described in "Warp Knitting Production” by Dr S. Raz, Melliand Textilberichte GmbH, Rohrbacher Str. 76, D-6900 Heidelberg, Germany (1987).
  • Suitable meshes are those described in, for example, US Patent Nos . 6,287,316, 6,783,554, 4,769,038, 4,347,847, 4,452,245, and 6,090,116. -
  • the growth surface is typically formed from a biocompatible compound.
  • the biocompatible compound may be a biocompatible polymeric compound.
  • the biocompatible polymeric compound is a polymeric elastomer.
  • Suitable polymeric elastomers include polyurethane, a polycarbonate urethane (such as Carbothane PG3570A, Chronoflex AR, Corethane 80A or Corethane 55D) , a polyether urethane, a polyether urethane urea, a polyether carbonate urethane, a polyether carbonate urethane urea, a polycarbonate urethane, a polycarbonate urethane urea, polycarbonate silicone urethane, a polycarbonate silicone urethane urea, a polydimethylsiloxane urethane, a polydimethylsiloxane urethane urea, a polyester urethane, a polyester urethane urea, pellet
  • the polymeric elastomer is typically non-absorbable .
  • the invention provides a biocompatible substrate for supporting tissue growth, the substrate comprising, a mesh having a network of interconnected filaments which define a plurality of apertures in the mesh, and a polymeric coating applied over the mesh to form a continuous surface for tissue growth.
  • the polymeric coating forms wells where the coating extends between filaments in the apertures defined by the filaments.
  • ridges are formed where the polymeric coating is disposed over the filaments.
  • the polymeric coating is typically a polymeric elastomer as described above.
  • the polymeric coating may be between 0.005 and 2 mm in thickness.
  • the polymeric coating may be between 0.005 and lmm in thickness.
  • the polymeric coating may be between 0.01 and 0.9 mm in thickness.
  • the polymeric coating may be between 0.01 and 0.8 mm in thickness.
  • the polymeric coating may be between 0.01 and 0.7 mm in thickness.
  • the polymeric coating may be between 0.01 and 0.5 mm in thickness .
  • the invention provides a substrate according to the first or second aspect, wherein the substrate is formed as a sheet having opposite major surfaces, the growth surface formed on at least one of the opposite major surfaces of the sheet.
  • the growth surface is formed on both opposite major surfaces.
  • the sheet is flexible.
  • the invention provides an implantable device, the device having the substrate of the first, second or third aspect disposed on an exterior surface of the device.
  • the substrate may be disposed on the exterior surface of the device by laminating or bonding the substrate to the exterior surface of the device. Methods for laminating or bonding are known in the art.
  • the substrate may be disposed on the exterior surface of the device by molding the substrate onto the exterior surface of the device.
  • the device may be a stent having an inner major surface defining a passage, and a major exterior surface.
  • the substrate may be disposed on the major exterior surface of the stent.
  • the device may be a tissue implant.
  • Suitable tissue implants include tissue partitioning implants, soft tissue surgical supports, bone implants, hollow organ implants, vascular support implants, surgical hernia support and repair implants.
  • the invention provides a method of producing a substrate for tissue growth, comprising:
  • the mesh may be any of the meshes described herein.
  • the polymeric coating is typically a polymeric elastomer.
  • the polymeric elastomer may be any of the polymeric elastomers described herein.
  • the invention provides a method of growing tissue comprising:
  • tissue Any type of tissue may be grown on the growth surface. Typical tissue types include muscle tissue, bone, heart tissue, skin tissue, peritoneal tissue, cartilage tissue, vascular tissue, bladder tissue, fascia tissue.
  • the tissue source may be cells applied to the substrate. The cells may be applied to the substrate in vitro or in vivo. Typically, the cells are applied to the substrate in vitro.
  • the tissue source may be intact tissue.
  • Suitable tissue sources which may be intact tissue include bone, heart, vascular tissue, bladder tissue, gastrointestinal tissue, skin, cartilage, facial tissue, teeth, other oral tissue.
  • the tissue source may be a wound formed in a tissue.
  • Suitable tissue sources in which a wound is formed in the tissue to provide a tissue source include bone, heart, skin, stomach, peritoneum, liver, skeletal muscle, vascular, bladder, other smooth muscle.
  • the substrate may be arranged to grow tissue in vitro.
  • the substrate mat be arranged to grow tissue in a wound.
  • the substrate may be arranged to grow tissue in a tissue deficit.
  • the tissue deficit may be, for example, due to a hernia defect, a cardiac defect, an aortic vascular deficit such as dissection, or an aortic aneurism.
  • the substrate may be arranged to grow tissue where surgical adhesions between tissue types are undesirable.
  • the substrate may be arranged in a manner whereby adhesions do not form on the substrate or on the growing tissue.
  • the substrate in the form of a sheet may be located in contact with a tissue type to support growth of the tissue over the growth surface. Growth of the tissue type over the growth surface encapsulates the substrate and prevents adhesions.
  • the substrate in the form of a sheet may be arranged with one major surface located in contact with a tissue type, and the opposite major surface facing outwards. Growth of the tissue type can then proceed on the major surface in contact with the tissue type, while the major surface facing outwards reduces or prevents adhesions.
  • tissue adhesions are not desirable when growing cardiac tissue, sternal tissue, abdominal tissue, or when surgical incisions are healing.
  • the substrate may be arranged to grow different tissue types separately.
  • the substrate in the form of a sheet may be located with the growth surface of one major side in contact with tissue of a first type, and the growth surface of an opposite major side in contact with tissue of a second type.
  • the tissue of the first type grows on the growth surface of the one major side
  • tissue of the second type grows on the growth surface of the opposite major side. Tissue of the first type growing on the one major side, and the tissue of the second type growing on the opposite major side, are separated by the substrate .
  • the invention provides tissue when grown using the substrate of the first to third aspects, or when grown by the method of the sixth aspect.
  • Figure 1 is a plan view of a substrate for tissue growth
  • Figure 2 is a partial perspective schematic view of the substrate of Figure 1;
  • Figure 3 is a mesh used to form the substrate of Figure 1;
  • Figure 4 is an example of a mesh which may be used to form a substrate for tissue growth
  • Figure 5 is a further example of a mesh which may be used to form a substrate for tissue growth
  • Figure 6 is a schematic view of the substrate of Figure 1 applied to a sternum.
  • Figure 1 and 2 illustrate a substrate 10 for tissue growth which is formed as a sheet structure.
  • the substrate 10 has a growth surface 11, formed on each of the opposite major surfaces 13, 14 of the substrate 10.
  • the growth surfaces are each continuous in that there are no apertures.
  • Each growth surface is textured to define a plurality of growth structures 12.
  • a single growth structure is circled in Figure 1.
  • Each growth structure comprises a continuous ridge 15 defining a space 16 in which a well 17 is formed.
  • the growth structures are not totally discrete, but rather adjacent growth structures share common ridge portions.
  • the ridges are interconnected to form a network of ridges across the growth surface.
  • the interconnected ridges are not all the same height but include raised rounded portions 18 extending upwardly from the growth structure.
  • the raised rounded portions are separated by lower ridge portions 19.
  • the detailed structure of the ridges in adjacent growth structures can be seen in Figure 2. Referring to Figure 2, the ridges of adjacent growth structures 22 and 23 include opposite upstanding walls 20 and a bridging portion 21.
  • the adjacent growth structures 22 and 23 share ridge 15, and the opposite upstanding walls 20 of ridge 15 define a portion of the wells 17 of the growth structures 22 and 23.
  • the wells 17 are formed in the space 16 made by the continuous ridge, and occupy a substantial part of the space defined by the continuous ridge.
  • the growth surface is formed from coating a knitted mesh 27 with a polymeric elastomer 28 such as Chronoflex AR.
  • the knitted mesh is typically a surgical mesh formed from polypropylene filaments 29 which are knitted or woven to form an interconnected network of filaments .
  • the shape or configuration of the mesh impresses or moulds the elastomer which overlays the mesh to provide the texture to the growth surface.
  • the height, size and shape of the ridges is determined by the configuration of the filaments. For example, single or multiple filaments with a low profile 30 form lower ridge portions 19, while bundles of filaments or looped filaments with a higher profile form raised ridge portions 18.
  • the wells 17 are formed in the spaces 16 between the filaments of the mesh.
  • Figure 3 shows the structure of the mesh used to form the substrate of Figure 1.
  • filaments 29 are interconnected at 33 by a loop 34 which gathers together the filaments.
  • the interconnected filaments define apertures 35.
  • the average maximum width of the apertures defined by the filaments is approximately 0.25 to 1 mm.
  • FIGs 2 and 3 when the mesh is coated with elastomer, wells 17 are formed in the apertures 35 of the mesh, while ridges 15 are formed where filaments 29 are coated with elastomer.
  • the substrate of Figure 1 was formed using Prolite mesh and Chronoflex as the polymeric elastomer.
  • Prolite Mesh Polypropylene Monofilament Mesh
  • Chronoflex AR (Viscosity 28,000 cps; solids 25%) was obtained from CardioTech International, Inc.
  • Synthesis of ChronoFlex® AR was carried out by the addition of MDI (diphenylmethane 4, 4 ' -diisocyanate) to polycarbonate diol, followed by addition of a mixture of chain extenders and a molecular weight regulator, with the reaction carried out in DMAC (Dimethyl Acetamide) solvent.
  • ChronoFlex® AR was supplied as a 22%-25% solids solution, ready for solution casting.
  • the mesh was dipped into the Chronoflex AR using a fume hood to prevent operator exposure to the solvent of
  • Chronoflex AR To facilitate coating, the mesh was rolled and dipped in the Chronoflex using forceps . Excess Chronoflex AR was drained over a 90-120 minute period in a fume hood. Following drying in the fume hood, the mesh was removed and placed suspended in a fan forced biological oven set at 70 degrees C for between 90 minutes and 120 minutes. Temperatures of between 60oC and 80oC may be used, typically in a forced hot air oven.
  • the substrate may be formed using other solvent casting techniques known in the art.
  • the substrate may be used for any applications which require tissue growth.
  • the substrate may be used for growth of heart and bone tissue, to prevent adhesions during tissue growth, in Laparoscopic hernioplasty, in Lichtenstein' s hernioplasty, as a sternal support, as a heart patch to support a thinned heart wall or hole in the heart, as a substrate for cell seeding and growth, as a coating for a stent, in the treatment of aneurysms by embolisation, to repair broken bone or stabilise bone tissue or cartilage associated with bone tissue, wound repair, addition or growth of tissue in plastic surgery, in vitro growth of tissue using, for example, cell culture techniques. Examples of applications of the substrate are provided below.
  • Example 1 Growth of heart and bone tissue
  • a mouse was anesthetized with intraperitoneal drug to induce general anesthesia. (4 mg/ml, 14 ⁇ l/g body wt, Nembutal, Abbott Laboratories; North Chicago, IL), placed in a supine position, and intubated. Mice were ventilated with a mixture of 100% oxygen and room air with a volume- cycled rodent ventilator (100 cycles/min, Harvard Apparatus; Holliston, MA) . Ventilator stroke volume was adjusted to fully inflate but not over-expand the lungs.
  • a limited thoracotomy was performed on the left side around the level of the 3 rd -4 th intercostal space, exposing the anterior surface of the heart.
  • the pericardium was opened and on the anterior surface of the heart and a 0.5 cm x 0.5 cm sheet of the substrate was placed and sutured to the epicardial surface of the heart.
  • the ligature was not removed after placement. After chest closure, mice were recovered in a sternal position and warmed.
  • the mouse was killed and the heart removed. It was noted on opening the chest cavity that the substrate had heart tissue and bone tissue encapsulating the substrate. The bone had derived from the rib where the substrate had interacted. Also the substrate had anchored to the surface of the heart. For removal of the substrate the rib and also the heart had to be removed in one piece. The substrate could not be seen directly due to its encapsulation by tissues.
  • Example 2 Growth of tissue on substrate compared to a surgical mesh without coating.
  • mice were anesthetized with an intraperitoneal injected drug to induce general anesthesia (4 mg/ml, 14 ⁇ l/g body wt f Nembutal, Abbott Laboratories; North Chicago, IL) , placed in a supine position, and a limited midline skin 5 abdominal incision was performed exposing the peritoneal tissue below the skin.
  • general anesthesia 4 mg/ml, 14 ⁇ l/g body wt f Nembutal, Abbott Laboratories; North Chicago, IL
  • a pocket was created to place either Atrium Prolite Mesh (5 animals) from Atrium Medical Corporation or a sheet of the substrate of Figure 1 (5 animals).
  • Each sheet of substrate measured 1 cm x 0.5 cm. 10
  • the mesh therefore was in contact with the skin above and also the peritoneum below. The incision was closed with skin sutures and the mice recovered.
  • mice shaved to 15 expose the implants.
  • the substrate could not be revealed in 4/5 by simply shaving the skin and were therefore encapsulated (by skin tissue from the skin) .
  • the mouse where the substrate had not been completely replaced by skin on its surface did have a skin 20 epidermis layer growing on the surface of the substrate.
  • tissue adhesions were present in all 30. implants. No such adhesions were noted when the substrate was used. This was determined by ease of excising the implants . Also noted was the fact that peritoneal tissue was growing through the Atrium Mesh to replace skin tissues. This was not the case with the substrate. Peritoneal tissue had grown on the side of the substrate that was in contact with peritoneal tissue, and skin had grown on the other side of the substrate that was exposed to tissue - thus the substrate had effectively separated the tissue layers, and had supported growth of the tissue layers on either side of the substrate. The growth of the tissue layers on either side of the substrate had resulted in encapsulation of the substrate.
  • the following is a prophetic example of the use of the substrate in the form of a sheet in laparoscopic hernioplasty.
  • the patient would be in general anesthesia and laying supine in a 20 degree Trendelenburg's position.
  • the abdominal cavity would be penetrated by a needle and insufflated up to 10 mmHg using carbondioxide gas.
  • Three troacars (10/12mm) would be thus placed: the first near the umbilicus and the other two some centimeters below on each side.
  • the hernial sac (peritoneum) would be grasped and pulled from the hernial defect.
  • the sac would then be opened by beginning the dissection laterally from the inner inguinal canal and advancing medially 3 cm across the edge of the rectus muscle.
  • the flap of peritoneum would be created under which the fascia of transversus abdominis would be seen.
  • a tightly rolled 8 x 10 cm sheet of the substrate (have growth structure on both sides) would be introduced into the abdominal cavity, unrolled and placed on the uncovered fascia area.
  • the peritoneal flap would then be placed over the substrate and both would be fixed onto the underlaying fascia with either sutures or 5 to 10 titanium staples.
  • the substrate could be placed in contact with the peritoneal tissues to promote complete encapsulation of the substrate with peritoneal tissue.
  • the operation would be terminated by desufflating the abdominal cavity, pulling out the trocars and suturing the three 1 cm wounds .
  • Lichtenstein ' s hernioplasty male patient could be carried out as follows: The patient lays supine. Some 10 to 20 ml of local anesthetic would be applied at the inguinal region. An incision measuring 7 cm would be positioned along the inguinal ligament and at the level of pubic symphysis. The roof of the inguinal canal would then be incised and the spermatic cord detached from its attachments. This reveals the hernial sac and allows the surgeon to invert it back to the abdominal cavity. The inguinal ligament and the lateral border of the rectus abdominis muscle would then be exposed. The substrate (size 5 cm x 15 cm) is then sutured to these structures. The mesh should now cover the entire inguinal canal allowing only the funicle to pass through.
  • the roof of the inguinal canal would then be reconstructed using resorbable sutures and the skin was closed by sutures or staples.
  • the patient may leave the hospital after some hours.
  • the usual sick leave time is 1 to 2 weeks, after which all daily activities are allowed.
  • the trauma caused by the dissection and the inflammation aroused by the substrate would be reduced by tissue growing around the substrate so as to reduce scar tissue and also adhesions.
  • the new tissue growth in combination with the substrate would support the bottom of the inguinal canal and prevent recurrent hernia formation.
  • Figure 6 illustrates the positioning of the substrate of Figure 1 on the sternum to assist in healing of a sternal break.
  • the substrate 10 is located over the sternum 42 and the growth surface is held in place against the sternum using metal wire 43 connected to the ribs 44.
  • the sternal substrate patch would be used to aid in preventing adhesions, promote sternal healing by promoting more rapid tissue and bone healing and reducing the chances for sternal break down in diabetic patients, obese patients and patients with immunological problems or are prone to slow healing or infection.
  • the following is a prophetic example of how to implant a heart patch using the substrate in the form of a sheet.
  • Standard anesthesia techniques and monitoring lines would be used in all patients. Appropriate prophylactic antibiotics would be given intravenously at induction. Sternotomy would be performed to expose the heart. Cardiac arrest could be induced by antegrade crystalloid cardioplegia. An anterior VSD associated with infarction, an incision could be made in the apex of the left ventricle parallel to the anterior descending artery 1 cm from it. Through the left ventriculotomy, the VSD would be closed using multiple monofilament interrupted mattress sutures with large pledgets of substrate which would be placed on the left ventricular side of the septum as far away from the rim of the infarcted area as possible.
  • a double substrate patch could be used to cover the VSD and necrotic septum around the VSD.
  • one or two mattress sutures passing through the full thickness of the anterior papillary muscle could be used.
  • the ventriculotomy could be closed with interrupted Teflon felt-reinforced mattress sutures.
  • the following is a prophetic example of how to seed a substrate in the form of a sheet.
  • a confluent plate of the cell type vascular smooth muscle would be processed for seeding. Muscle cell cultures would be trypsinized, collected, washed and combined in one tube. One surface of the substrate would be seeded with the resuspended smooth muscle cell population. The cell- seeded polymer coated mesh would be incubated in Dulbeccos ' s Modified Eagles Medium (DMEM, Sigma, St. Louis, Mo.) supplemented with 10% fetal calf serum (Biowhittaker Inc., Walkersville, Md.). The medium would be changed at 12 hour intervals to ensure sufficient supply of nutrients.
  • DMEM Dulbeccos ' s Modified Eagles Medium
  • the medium would be changed at 12 hour intervals to ensure sufficient supply of nutrients.
  • Zilver stents may have a substrate in the form of a sheet applied to the exterior surface (externally applied chronoflex endografts) (ECE) or to the internal stent surface (internally applied chronoflex endografts) (ICE) . All stents used in this study would be 4-5 cm long and 8 mm in diameter. ICEs and ECEs would be constructed by covering bare metal stents with a sheet of substrate 200-500 ⁇ m thick. The Chronoflex coated mesh sheet could be first sutured into a tube with running sutures.
  • the Chronoflex coated mesh would be rolled into a tube and attached to the inner surface of the stent by suturing with 7-0 Prolene monofilament (Ethicon, Somerville, NJ) .
  • Running sutures could be placed longitudinally at every second row of the smaller Z pattern of the Zilver stents.
  • the substrate could be connected on the exterior surface of the stent at both ends with running sutures.
  • the following is a prophetic example of how to produce a coil preparation for embolization of aneurysms using the substrate.
  • An embolization device could be created by constructing a 8-millimeter-long, 5-mm-diameter, spiral-shaped mesh substrate ribbons. Coil ribbons could be made from the substrate in the form of a tube which is then cut into spirals . The substrate may be surgically implanted into an aneurysm sac. An eight-millimeter-long, 5-mm-diameter, spiral-shaped coil substrate would be sufficient to treat an aneurysm with the following measurements: Aneurysm sacs (8 to 12 mm) and necks (7 mm) . It should be appreciated that different sized substrate spiral coils can be custom made to the dimensions of radiological determined aneurysms .
  • the substrate could also be bonded to a flexible Guglielmi detachable coils (GDCs; Boston Scientific/Target Therapeutics) .
  • the substrate may be threaded over the twisty coil or sutured to the coil.
  • GDCs Guglielmi detachable coils
  • An example of the use of the substrate attached to the surface of the coil to treat an aneurysm is the technique where a relevant cerebral vessel leading to aneurysm is catheterized with a 6F guide catheter.
  • the aneurysm can then be catheterized with a 0.14-inch or 0.10-inch microcatheter, for example a Rebar 14 (Microtherapeutics, Irvine, CA), a Tracker Excel 14 (Target Therapeutics/Boston Scientific, Fremont, CA) , or a Prowler 14 (Cordis, Miami Lakes, FL) , with appropriate stream shaping of the catheter tip. Catheter position would be verified by means of angiography. After successful stent placement or positioning of the catheter a coil substrate embolization may be performed with the Guglielmi detachable substrate bonded coils through a microcatheter (Excelsior SL-IO; Boston Scientific/Target Therapeutics) placed in the aneurysm.
  • a microcatheter Excelsior SL-IO; Boston Scientific/Target Therapeutics
  • FIGs 4 and 5 illustrate scanning electron micrographs of examples of meshes that would be suitable for producing a substrate for tissue growth.
  • polypropylene filaments 45 are interconnected by loops 46 at 47.
  • the interconnected filaments define apertures 48.
  • polypropylene filaments 49 are interconnected by a series of loops 50.
  • the interconnected filaments define major apertures 51.
  • the shape of the apertures defined by the interconnected filaments is different between the different meshes.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Botany (AREA)
  • Composite Materials (AREA)
  • Materials Engineering (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Cell Biology (AREA)
  • Zoology (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un substrat biocompatible pour supporter la croissance de tissus, le substrat ayant une surface de croissance qui supporte la croissance de tissus, la surface de croissance étant texturée pour définir une pluralité de structures de croissance, chacune des structures de croissance comprenant une arête continue et un godet qui est formé dans un espace défini par la rainure ; ainsi que des procédés de production du substrat et des procédés d'utilisation du substrat pour la croissance de tissus.
PCT/AU2005/001697 2005-11-04 2005-11-04 Substrat pour croissance de tissus Ceased WO2007051221A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/AU2005/001697 WO2007051221A1 (fr) 2005-11-04 2005-11-04 Substrat pour croissance de tissus

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/AU2005/001697 WO2007051221A1 (fr) 2005-11-04 2005-11-04 Substrat pour croissance de tissus

Publications (1)

Publication Number Publication Date
WO2007051221A1 true WO2007051221A1 (fr) 2007-05-10

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* Cited by examiner, † Cited by third party
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US8317808B2 (en) 2008-02-18 2012-11-27 Covidien Lp Device and method for rolling and inserting a prosthetic patch into a body cavity
CN101773687B (zh) * 2009-12-31 2013-06-05 陕西瑞盛生物科技有限公司 一种复合软组织补片的制备方法
US8758373B2 (en) 2008-02-18 2014-06-24 Covidien Lp Means and method for reversibly connecting a patch to a patch deployment device
US8808314B2 (en) 2008-02-18 2014-08-19 Covidien Lp Device and method for deploying and attaching an implant to a biological tissue
US8906045B2 (en) 2009-08-17 2014-12-09 Covidien Lp Articulating patch deployment device and method of use
US9034002B2 (en) 2008-02-18 2015-05-19 Covidien Lp Lock bar spring and clip for implant deployment device
US9044235B2 (en) 2008-02-18 2015-06-02 Covidien Lp Magnetic clip for implant deployment device
US9301826B2 (en) 2008-02-18 2016-04-05 Covidien Lp Lock bar spring and clip for implant deployment device
US9393093B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US9393002B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US9398944B2 (en) 2008-02-18 2016-07-26 Covidien Lp Lock bar spring and clip for implant deployment device
US9833240B2 (en) 2008-02-18 2017-12-05 Covidien Lp Lock bar spring and clip for implant deployment device
US9999424B2 (en) 2009-08-17 2018-06-19 Covidien Lp Means and method for reversibly connecting an implant to a deployment device
CN109069251A (zh) * 2015-12-04 2018-12-21 制定实验室公司 植入物的纹理化表面
CN115105640A (zh) * 2022-06-20 2022-09-27 四川大学 一种可以骨性愈合连接的隆鼻植入体及其制备方法

Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5219361A (en) * 1988-09-16 1993-06-15 Clemson University Soft tissue implant with micron-scale surface texture to optimize anchorage
US5326354A (en) * 1991-05-09 1994-07-05 Howmedica Inc. Method for forming attachment surfaces on implants
US5876447A (en) * 1996-02-14 1999-03-02 Implantech Associates Silicone implant for facial plastic surgery
US6127596A (en) * 1998-01-23 2000-10-03 Sulzer Orthopedics Inc. Implantable orthopedic prosthesis having tissue attachment surface and method of manufacture
WO2002022047A1 (fr) * 2000-09-14 2002-03-21 C.R. Bard, Inc. Prothese implantable
US6419491B1 (en) * 1993-11-02 2002-07-16 Bio-Lok International, Inc. Dental implant system with repeating microgeometric surface patterns
US6447551B1 (en) * 1999-03-20 2002-09-10 Aesculap Ag & Co. Kg Flat implant, process for its production and use in surgery
US6454569B1 (en) * 1993-11-02 2002-09-24 Biolok International, Inc. Dental implant having a dual bio-affinity collar
US20030065401A1 (en) * 2001-01-25 2003-04-03 Mark Amrich Textured surface having undercut micro recesses in a surface
WO2003034951A1 (en) * 2001-10-20 2003-05-01 Osseobiotek Ltd Implant and method of manufacturing thereof
US6599322B1 (en) * 2001-01-25 2003-07-29 Tecomet, Inc. Method for producing undercut micro recesses in a surface, a surgical implant made thereby, and method for fixing an implant to bone
US6620332B2 (en) * 2001-01-25 2003-09-16 Tecomet, Inc. Method for making a mesh-and-plate surgical implant
US20050119758A1 (en) * 2003-07-30 2005-06-02 Bio-Lok International Inc. Surgical implant for promotion of osseo-integration
US20050149170A1 (en) * 1998-08-25 2005-07-07 Tassel Robert A.V. Implantable device for promoting repair of a body lumen

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5219361A (en) * 1988-09-16 1993-06-15 Clemson University Soft tissue implant with micron-scale surface texture to optimize anchorage
US5326354A (en) * 1991-05-09 1994-07-05 Howmedica Inc. Method for forming attachment surfaces on implants
US6454569B1 (en) * 1993-11-02 2002-09-24 Biolok International, Inc. Dental implant having a dual bio-affinity collar
US6419491B1 (en) * 1993-11-02 2002-07-16 Bio-Lok International, Inc. Dental implant system with repeating microgeometric surface patterns
US5876447A (en) * 1996-02-14 1999-03-02 Implantech Associates Silicone implant for facial plastic surgery
US6127596A (en) * 1998-01-23 2000-10-03 Sulzer Orthopedics Inc. Implantable orthopedic prosthesis having tissue attachment surface and method of manufacture
US20050149170A1 (en) * 1998-08-25 2005-07-07 Tassel Robert A.V. Implantable device for promoting repair of a body lumen
US6447551B1 (en) * 1999-03-20 2002-09-10 Aesculap Ag & Co. Kg Flat implant, process for its production and use in surgery
WO2002022047A1 (fr) * 2000-09-14 2002-03-21 C.R. Bard, Inc. Prothese implantable
US20030065401A1 (en) * 2001-01-25 2003-04-03 Mark Amrich Textured surface having undercut micro recesses in a surface
US6599322B1 (en) * 2001-01-25 2003-07-29 Tecomet, Inc. Method for producing undercut micro recesses in a surface, a surgical implant made thereby, and method for fixing an implant to bone
US6620332B2 (en) * 2001-01-25 2003-09-16 Tecomet, Inc. Method for making a mesh-and-plate surgical implant
WO2003034951A1 (en) * 2001-10-20 2003-05-01 Osseobiotek Ltd Implant and method of manufacturing thereof
US20050119758A1 (en) * 2003-07-30 2005-06-02 Bio-Lok International Inc. Surgical implant for promotion of osseo-integration

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9301826B2 (en) 2008-02-18 2016-04-05 Covidien Lp Lock bar spring and clip for implant deployment device
US10159554B2 (en) 2008-02-18 2018-12-25 Covidien Lp Clip for implant deployment device
US9393093B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US8808314B2 (en) 2008-02-18 2014-08-19 Covidien Lp Device and method for deploying and attaching an implant to a biological tissue
US8317808B2 (en) 2008-02-18 2012-11-27 Covidien Lp Device and method for rolling and inserting a prosthetic patch into a body cavity
US9034002B2 (en) 2008-02-18 2015-05-19 Covidien Lp Lock bar spring and clip for implant deployment device
US9044235B2 (en) 2008-02-18 2015-06-02 Covidien Lp Magnetic clip for implant deployment device
US10182898B2 (en) 2008-02-18 2019-01-22 Covidien Lp Clip for implant deployment device
US9393002B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US8758373B2 (en) 2008-02-18 2014-06-24 Covidien Lp Means and method for reversibly connecting a patch to a patch deployment device
US9398944B2 (en) 2008-02-18 2016-07-26 Covidien Lp Lock bar spring and clip for implant deployment device
US9833240B2 (en) 2008-02-18 2017-12-05 Covidien Lp Lock bar spring and clip for implant deployment device
US8734473B2 (en) 2009-02-18 2014-05-27 Covidien Lp Device and method for rolling and inserting a prosthetic patch into a body cavity
US8906045B2 (en) 2009-08-17 2014-12-09 Covidien Lp Articulating patch deployment device and method of use
US9999424B2 (en) 2009-08-17 2018-06-19 Covidien Lp Means and method for reversibly connecting an implant to a deployment device
CN101773687B (zh) * 2009-12-31 2013-06-05 陕西瑞盛生物科技有限公司 一种复合软组织补片的制备方法
CN109069251A (zh) * 2015-12-04 2018-12-21 制定实验室公司 植入物的纹理化表面
US11202698B2 (en) 2015-12-04 2021-12-21 Establishment Labs S.A. Textured surfaces for implants
CN115105640A (zh) * 2022-06-20 2022-09-27 四川大学 一种可以骨性愈合连接的隆鼻植入体及其制备方法

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