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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/04—Macromolecular materials
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/04—Macromolecular materials
  • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• • C—CHEMISTRY; METALLURGY
  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
  • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
  • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
  • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
  • C08L23/10—Homopolymers or copolymers of propene
• • C—CHEMISTRY; METALLURGY
  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
  • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
  • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
  • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
  • C08L23/10—Homopolymers or copolymers of propene
  • C08L23/12—Polypropene
• • C—CHEMISTRY; METALLURGY
  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
  • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
  • C08L27/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers
  • C08L27/02—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment
  • C08L27/12—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment containing fluorine atoms
• • C—CHEMISTRY; METALLURGY
  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
  • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
  • C08L27/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers
  • C08L27/02—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment
  • C08L27/12—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment containing fluorine atoms
  • C08L27/16—Homopolymers or copolymers or vinylidene fluoride
• • C—CHEMISTRY; METALLURGY
  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
  • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
  • C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
  • C08L67/04—Polyesters derived from hydroxycarboxylic acids, e.g. lactones

Definitions

• the invention relates to a surgical implant, in particular an implant with a flexible basic structure configured as an implant mesh.
• the object of the invention is to provide a surgical implant, in particular an implant with a flexible basic structure configured as an implant mesh, which, after implantation, shows a reduced inflammatory reaction and reduced connective tissue induction.
• the surgical implant according to the invention has a flexible basic structure which comprises a first component of resorbable material and a second component of non-resorbable material and/or of slowly resorbable material.
• the slowly resorbable material of the second component if present, _ is resorbed more slowly than the material of the first component.
• the slowly resorbable material preferably has a resorption time of at least 60 days or still has a tear strength, 30 days after implantation, which is at least 10% of the initial tear strength.
• the elongation at tear of the first component is at least 1.25 times the elongation at tear of the second component.
• the first component and the second component are designed such that, after implantation, the elongation at tear of the first component and that of the second component are identical at a time which lies in the range of from 2 days to 90 days after implantation.
• the basic structure is configured as an implant mesh, the first component having filaments of a copolymer of glycolide and caprolactone and the second component having filaments of polypropylene.
• the filaments of the first component are preferably monofilaments with a thickness in the range of from
• the filaments of the second component are preferably monofilaments with a thickness in the range of from 0.08 mm to 0.15 mm.
• the pores of the basic structure configured as an implant mesh preferably have, across at least 90% of the total pore surface, a respective area in the range of from 2 mm 2 to 25 mm 2 , i.e. the pores are relatively large.
• the implant according to the invention has a relatively high degree of strength in order to mechanically stabilize the area in which the initial wound healing takes place.
• This high initial strength is a result of the relatively high elongation at tear of the first component, correlating with a high tear strength.
• the tear strength of the first component rapidly declines so that the subsequent phase of wound healing can run its course without mechanical irritation by the implant. This leads to a marked reduction in the inflammatory reaction, and there is no initial increase in connective tissue induction.
• the second component ensures the mechanical stability in the later phase of healing.
• the particularly preferred embodiment is already relatively soft to start with (i.e.
• the initial ratio of the elongation at tear of the first component and that of the second component results in a favourable elongation behaviour, and the marked reduction of the inflammatory reaction and the absence of an initial increase in connective tissue induction have already been mentioned.
• the resorbable first component already has a lower elongation at tear than the in this case non-resorbable second component, and it will thereafter decline still further.
• the tissue reaction is much less pronounced than in commercially available comparison samples, namely non- resorbable implant meshes made of polypropylene and resorbable implant meshes made of glycolide/lactide copolymers ("Vicryl", Ethicon, glycolide to lactide ratio 90:10).
• the tissue reaction is not only less than in the case of a "Vicryl" mesh, but also less than in the case of a polypropylene mesh, although an initial reaction to the products of degradation of the first component is to be expected.
• the initial elongation at tear of Vicryl" and of polypropylene is about 20%, in other words roughly equal, in contrast to the initial elongation at tear of the first component and of the second component of the implant according to the invention.
• the material of the first component comprises copolymers of glycolide and caprolactone ("Monocryl", Ethicon) .
• PDS poly-p-dioxanone
• polypropylene ("Prolene", Ethicon)
• possible materials of the second component are in particular fluorine-containing polyolefins and mixtures of polyvinylidene fluoride and copolymers of vinylidene fluoride and hexafluoropropylene (e.g. the material "Pronova” from Ethicon), and other materials too.
• Typical ranges of the elongation at tear for the first component (resorbable part) are:
• Typical ranges of the elongation at tear for the second component are:
• the first component can be present in the implant in many different forms, for example as yarn, monofilament, multifilament, twine, twisted structure or tape, and also in several of these forms or in other forms.
• mixed forms are conceivable, for example twines consisting of filaments of the first component and filaments of the second component.
• the thickness is preferably in the range of from 0.01 mm to 0.5 mm, while the width of a tape is preferably in the range of from 0.05 mm to 1 mm.
• the basic structure is areal and configured as an implant mesh (in particular for hernia repair or for use at the pelvic floor), e.g. as a ⁇ knitted structure.
• an implant mesh in particular for hernia repair or for use at the pelvic floor
• a ⁇ knitted structure e.g. as a ⁇ knitted structure.
• a great many configurations are in general conceivable for the basic structure, for example areal structures, mesh-like structures, knitted mesh-like structures, supports for tissue cultures, supports for cell cultures, supports for active substances, textile configurations, three-dimensional structures.
• the implant according to the invention is provided with colour markings (for example in the form of stripes) , for example with the aid of filaments of different colour worked into the basic structure or with marking stripes imprinted onto the basic structure, the handling of the implant can be made easier, depending on the application.
• colour markings for example in the form of stripes
• Fig. 1 shows a histogram illustrating in graph form the results from Example 3 (Table 3) ,
• Fig. 2 shows a further histogram illustrating in graph form the results from Example 3 (Table 4),
• Fig. 3 shows an illustration of the fibrous reaction of conventional implant meshes in the course of resorption
• Fig. 4 shows an illustration of the inflammatory reaction of conventional implant meshes in the course of resorption.
• a twine was first produced on a "Lezzini" two-stage twining machine, one "Monocryl” monofilament and one "Prolene” monofilament being highly twisted at 170 S T/m and the two components then being twined at 120 Z T/m.
• the tear strength (in N) and the elongation at tear (in %, with respect to the length of the unloaded sample) of the two components were determine ' d by measurements of the twine ' using a , ⁇ Statima"t" testing machine, specifically for different degrees of resorption of the "Monocryl" component.
• the respective twine was artificially aged for a predetermined time in a climatic cabinet at 25 °C and 85% relative humidity, for up to 2 weeks to obtain the highest degree of resorption.
• a measure of the degree of degradation of the resorbable part is the inherent viscosity.
• Table 1 shows the tear strength and elongation at tear for the two monofilaments (components), and the inherent viscosity as a measure of the degree of resorption of the " onocryl" component, specifically as the mean value for the five samples.
• the two monofilaments initially differ in tear strength and elongation at tear.
• the tear strength and the elongation at tear of the resorbable component continuously decline until they practically match the tear strength and the elongation at tear of the non-resorbable part at inherent viscosities of 0.83 dl/g.
• This mesh was produced as a crochet galloon knit of PP monofilaments ("Prolene”, Ethicon) of thread thickness 3.5 mils (0.089 mm) and a resorbable monofilament ("Monocryl”, Ethicon, copolymer of glycolide and caprolactone) of thread thickness #5-0 (according to USP; i.e. 0.1 mm) .
• Pattern warp as dense fringe (PP monofilament)
• the PP monofilament/"Monocryl" monofilament mixture can be doubled, but preferably also twined.
• the crochet galloon knit was washed with an organic solvent in order to wash off residues of processing aids, then tensioned on frames and annealed at high temperatures for several hours under a dry inert gas.
• the knit was annealed at 113 °C for 9 hours in a dry nitrogen atmosphere (dew point ⁇ -20°C) .
• the knit (crochet galloon knit) was then cut to size, packaged, and sterilized with ethylene oxide.
• the "Monocryl" part of the mesh had an inherent viscosity (measured in hexafluoroisopropanol as solvent) of 1.19 dl/g.
• the "Monocryl" part had an inherent viscosity of 0.59 dl/g.
• Mesh 3 was produced analogously to Mesh 1, but instead of "Monocryl" of thread size # 5-0, the thinner thread size # 6-0 (according to 'USP; i.e. 0.07 mm) was used. Part of the "Monocryl” was coloured with "D+C violet” so that areas of the implant had coloured stripes.
• the inherent viscosity of the "Monocryl" part of the sterile finished knit was 0.97 dl/g.
• Polypropylene (PP) can for example ' be replaced by “Pronova” (Ethicon; mixture of fluorinated polyolefins, specifically of polyvinylidene fluoride and copolymers of vinylidene fluoride and hexafluoropropylene) , "Monocryl” for example by “PDS” (Ethicon; homopolymer of poly-p-dioxanone) .
• Pronova Ethicon; mixture of fluorinated polyolefins, specifically of polyvinylidene fluoride and copolymers of vinylidene fluoride and hexafluoropropylene
• Monocryl for example by “PDS” (Ethicon; homopolymer of poly-p-dioxanone) .
• Mesh 5 in Example 2 They all include a "Prolene” monofilament with a thread diameter of 3.5 mils (0.089 mm), and meshes 1 to 4 additionally include a
• the test was carried out with the aid , of paraffin sections and EvG-, HE- and PS-stained slides. Microscopic and morphometric evaluations were performed by means of conventional light microscopy (HE stain, EvG stain, Sirius RED stain) .
• the inflammatory infiltrate (IF) was measured at 10 representative sites as distance in ⁇ m; this is the width of the inner granuloma part (macrophage wall) .
• IF inflammatory infiltrate
• the connective tissue capsule (CT) was measured in eacn preparation at 10 representative sites as distance in ⁇ m; this is the width of the outer granuloma part (fibrocyte wall) .
• CT connective tissue capsule
• the immunohistochemistry results on cell response were measured in 10 grid squares with an edge length of 250 ⁇ m per section. To determine the percentage cell proportion, the total cell number appearing in the grid square was determined on the one hand, and the specifically Ki 67-positive and Tunel- positive cells were counted on the other.
• Figures 3 and 4 illustrate, for comparison, typical results of fibrous reaction and inflammatory reaction for heavy implant meshes made of polypropylene monofilaments (with a surface weight of ca. 100 g/m 2 ) , for a "Vicryl”-containing composite mesh ("vypro", Ethicon, made of polypropylene multifilament yarn and "Vicryl” yarn) , for a pure "Vicryl” mesh, and for controls without implant.
• vypro Ethicon

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• 2003
  • 2003-02-25 DE DE10307946.7A patent/DE10307946B4/de not_active Expired - Lifetime
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