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WO2008075398A2 - Prothèse chirurgicale à toile tissée pour utilisation chirurgicale et procédé de fabrication - Google Patents

Prothèse chirurgicale à toile tissée pour utilisation chirurgicale et procédé de fabrication Download PDF

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Publication number
WO2008075398A2
WO2008075398A2 PCT/IT2007/000890 IT2007000890W WO2008075398A2 WO 2008075398 A2 WO2008075398 A2 WO 2008075398A2 IT 2007000890 W IT2007000890 W IT 2007000890W WO 2008075398 A2 WO2008075398 A2 WO 2008075398A2
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WO
WIPO (PCT)
Prior art keywords
mesh
prosthesis according
prosthesis
fibres
nanofibres
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/IT2007/000890
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English (en)
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WO2008075398A3 (fr
Inventor
Cristina Buemi
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.)
Dipro Sas Di Buemi Enrico & C
Original Assignee
Dipro Sas Di Buemi Enrico & C
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from ITTO20060908 external-priority patent/ITTO20060908A1/it
Priority claimed from ITTO20070846 external-priority patent/ITTO20070846A1/it
Application filed by Dipro Sas Di Buemi Enrico & C filed Critical Dipro Sas Di Buemi Enrico & C
Publication of WO2008075398A2 publication Critical patent/WO2008075398A2/fr
Publication of WO2008075398A3 publication Critical patent/WO2008075398A3/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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B21/00—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B21/10—Open-work fabrics
    • D04B21/12—Open-work fabrics characterised by thread material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene
    • D10B2509/08—Hernia repair mesh

Definitions

  • Surgical prosthesis including a woven mesh for surgical use and a method of manufacturing thereof
  • the present invention relates to a prosthesis including a woven mesh for surgical use, suitable for use with tension-free techniques and in particular with the tension-free sutureless technique.
  • the present invention relates to a prosthesis including a woven mesh for surgical use having properties of softness and extreme lightness (ultralightness), as well as stability.
  • the present invention relates to a prosthesis including a woven mesh for surgical use, which is soft and ultra-lightweight as well as being stable, and is suitable for use as a prosthesis for hernioplasty, and more specifically for inguinal hernioplasty.
  • the prosthesis according to the invention may also be used for repairing and reinforcing the abdominal wall and the inguinal region of the pelvic floor, and for the treatment of incontinence.
  • Hernia is the most frequent surgical problem throughout the world. It occurs when the intestines pass out of the abdominal cavity, where they are normally contained, through the muscular wall together with the peritoneum, which forms the hernial sac, that is the natural enclosure for the abdominal cavity.
  • inguinal region (inguinal hernia)
  • crural region which is a little further down than the inguinal region and precisely at the head of the thigh
  • umbilical and periumbilical region (umbilical hernia)
  • epigastric region which lies on the median line between the umbilicus and the xiphoid of the sternum (epigastric hernia).
  • epigastric hernia epigastric hernia
  • Hernia takes the form of a non-painful swelling which can be reduced manually and is initially of small size. Over time it can however increase in volume, become painful and no longer reducible.
  • hernipplasty comprises repairing and strengthening the yielding part of the muscular wall, thus closing the breach through which hernia formation has occurred.
  • Tension-free techniques do not provide for opening of the fascia trasversalis and substantially comprise positioning a prosthesis above that fascia, the prosthesis being secured with or without sutures.
  • Prostheses developed according to the abovementioned tension-free sutureless technique are known for example from European Patent application no. EP 0 827 724 A2 in the name of Herniamesh S.r.l..
  • This application describes prostheses for hernioplasty constructed using a mesh of biocompatible plastics material and more precisely a pre-shaped mesh of polypropylene monofilament, preferably in the anatomical shape of a nail.
  • the mesh prosthesis described in the abovementioned patent application has the desired surgical quality, which is imparted by adequate porosity to encourage fibroblast infiltration and consequently resistance to infections; the said prosthesis is also stable, that is to say it does not tend to shrink, as a result of appropriate treatments which confer upon it so-called controlled memory.
  • This prosthesis is however somewhat rigid and thick to be positioned and held in position without the need of sutures as envisaged in the tension-free sutureless technique. These properties are influenced by the diameter of the monofilament and the type of mesh and produce a mesh of some weight, which has the inconvenience that it may be somewhat uncomfortable for the patient, particularly when engaging in working and sporting activities.
  • the . prostheses used with tension-free techniques are normally overdimensioned with regard to the actual tensions which they have to withstand. This gives rise to excessive quantity and a not insignificant weight of extraneous material introduced into the patient's body, which is therefore uncomfortable for the patient.
  • prostheses based on thick rigid meshes which ensure good mechanical stability because of the fact that they close off the hernial defect causing the maximum scar tissue formation; the mesh itself and the substantial scar formation ensure a lasting and strong repair of the hernia.
  • These meshes which have pore dimensions of typically less than 1 mm in both breadth and length and are suitable for use with the tension-free sutureless technique nevertheless have the disadvantage that they cause the patient some discomfort because of their rigidity and thickness. Cases of an excessive scar-forming response to the prosthesis causing rigidity in the abdominal wall with consequent discomfort for the patient have also been reported in the literature;
  • prostheses based on lightweight meshes which have been conceived in order to follow the physiological movement of the abdominal wall and the inguinal region are manufactured with a small monofilament diameter and large pores, typically larger than 1 mm in both breadth and length.
  • These prostheses give rise to less scar tissue formation, but their excessive softness makes them very difficult to use with tension-free techniques and does not in fact make it possible to use the tension-free sutureless technique. They also have unsatisfactory mechanical properties.
  • the applicant has now selected a woven mesh which extremely advantageously combines the properties of stability and sufficient rigidity required for use as prosthesis in hernioplasty surgery using tension-free techniques, and more specifically the tension-free sutureless technique, with those of ultralightness, softness and macroporosity which render prostheses based on such mesh particularly comfortable for the patient and particularly effective in preventing the occurrence of infections, as well as being capable of reestablishing abdominal functions and being physiologically incorporated in the abdominal wall with maximum biocompatibility.
  • a prosthesis based on such a mesh also reduces the occurrence of long term complications such as recurrence, infections or chronic pain, and also offers optimum handling properties for easy repair of the hernia, thus achieving a balanced relationship between the material introduced into the patient's body and the need for a correct and reliable hold.
  • the use of the woven mesh identified by the applicant for the construction of implantable prostheses for repair surgery, in particular hernioplasty makes it possible to overcome the limitations of the prior art.
  • the present invention therefore relates to a surgical prosthesis including a woven mesh for surgical use comprising a biocompatible monofilament of plastics material, the said mesh having a weight per unit area within the range 25 to 100 g/m 2 , a three-dimensional percentage porosity within the range 80 to 95% and a tensile strength in the longitudinal direction in the range of approximately 16 to 32 N/cm.
  • the two-dimensional porosity of the mesh is preferably 60%; values between 55% and 75% will however impajt the desired physical and mechanical properties to the mesh.
  • the abovementioned weight per unit area and porosity values are substantially comparable with those for lightweight meshes (for example BARD'S SoftMesh or FEG's Dynamesh-PP Light).
  • the prosthesis according to the invention at the same time demonstrates mechanical properties which are superior to those of lightweight meshes, which make it more like heavy meshes. These properties make the aforementioned mesh particularly suitable for use as a prosthesis for the repair of hernial defects and defects of the abdominal wall using tension-free techniques, and more specifically using the tension-free sutureless technique.
  • the mesh used for construction of the prosthesis according to the invention can be manufactured using simple and economical processes.
  • FIG. 1 shows a plan view of a preferred embodiment of a prosthesis including a woven mesh for surgical use according to the invention
  • FIG. 2 shows a detail of the prosthesis in Figure 1 relating to the structure of the larger pores of the mesh and the four threads connecting two opposite sides of each of the aforesaid larger pores,
  • FIG. 3 shows a detail of the prosthesis in Figure 1 relating to the structure of the smaller pores in the mesh
  • FIG. 4A and 4B show a diagrammatical plan view and lateral view respectively of a first embodiment of the prosthesis illustrated in Figure 1,
  • FIG. 5A and 5B show a diagrammatical plan view and lateral view respectively of a second embodiment of the prosthesis illustrated in Figure 1,
  • - figures 6A and 6B show a diagrammatical plan view and lateral view respectively of a third embodiment of the prosthesis illustrated in Figure 1
  • - figures 7 A and 7B show a diagrammatical plan view and lateral view respectively of a fourth embodiment of the prosthesis illustrated in Figure 1
  • FIG. 8A and 8B show a diagrammatical plan view and lateral view respectively of a fifth embodiment of the prosthesis illustrated in Figure 1,
  • FIG. 9A and 9B show a diagrammatical plan view and lateral view respectively of a sixth embodiment of the prosthesis illustrated in Figure 1,
  • FIG. 10 shows the bend angle for various types of mesh prosthesis for surgical use characterised by different weights.
  • a mesh similar to mesh 1 is in itself known.
  • it is manufactured by Tessitura TEXIVA s.r.l. (product code 18bisl2), but hitherto this mesh has only been used for applications such as the manufacture of industrial filters, which have nothing to do with medical devices and even less with prostheses for hernioplasty or other types of surgery using tension-free or tension-free sutureless techniques.
  • woven mesh is meant a mesh manufactured using known techniques for weaving fabrics by weaving warp and weft threads.
  • Figure 1 shows an embodiment in which the prosthesis is shaped and includes a mesh 1 substantially shaped in the form of a nail, having two longer sides 7a, 7b which are substantially parallel to each other, joined at one extremity by a substantially straight shorter side 9 and at the other extremity by a side 11 having a curvilinear profile.
  • the prosthesis including mesh 1 preferably has a hole 3 located approximately in the centre of the prosthesis, and a slit 5 which extends from said hole 3 parallel to said longer sides 7a, 7b as far as said shorter side 9. Hole 3 and slit 5 are obtained for example by a process of hot cutting with a predetermined shape.
  • Figures 4A and 4B respectively show a diagrammatical plan view and a lateral view of a preferred embodiment of the prosthesis according to the invention, that is a prosthesis substantially shaped in the form of a nail with a hole.
  • the dimensions of the prosthesis are 45.00 mm x 100.00 mm, but they may have any value up to 80.00 mm x 150 mm according to the envisaged application; the hole diameter is 12.00 mm and the thickness of the mesh is from 0.59 mm to 0.8 mm.
  • Mesh 1 whose structure is illustrated in Figure 1, is manufactured from a monofilament of biocompatible plastics material produced by extrusion, preferably of polypropylene, which is woven through the use of suitable looms capable of producing a weave of the Raschel type.
  • a weave of the Raschel type is meant a system of knotted mesh weaving which renders the fabric non-running. This weaving is carried out using suitable looms known as Raschel looms.
  • mesh 1 has larger pores 4a and smaller pores 4b, as well as woven knots 6.
  • the diameter of the polypropylene monofilament constituting mesh 1 is preferably approximately 120 microns. However, a monofilament diameter which has any value within the range of 114 micron to 135 micron is sufficient to ensure the desired balance between the physical and mechanical properties of mesh 1 and its weight per unit area.
  • weight per unit area of mesh 1 this is preferably 48 g/m ⁇ 5 %; however, a weight per unit area of between 25 g/m 2 and 100 g/m 2 is acceptable in order to ensure the desired comfort for the patient.
  • Each pore 4a is delimited by a ring having opposite sides (2a, 2b) connected by at least four threads (8a, 8b, 8c, 8d).
  • the presence of the said at least four threads 8a, 8b, 8c and 8d confers sufficient rigidity and stability upon mesh 1 for it to be used as a prosthesis in tension-free techniques, preferably in the tension-free sutureless technique.
  • This structure confers the desired stability and rigidity properties upon the mesh to ensure easy and secure positioning of the mesh.
  • the four threads 8a, 8b, 8c and 8d present in the hexagonal pore favour the use of adhesive as a means of attaching the prosthesis because they represent a suitable substrate for the material.
  • each larger pore 4a in both breadth and length, suitable for ensuring the desired balance between the physical and mechanical properties of mesh 1 and its porosity, preferably lie between 2 mm and 6 mm. Preferred dimensions are 3.97 mm x 2.37 mm.
  • Figure 3 shows the substantially rhombus shape of smaller pores 4b.
  • the dimensions of each smaller pore 4b in both breadth and length preferably lie within the range 2.25 to 2.36 mm; however a value of between 2.00 mm and 3.00 mm is suitable for ensuring the desired balance between the physical and mechanical properties of mesh 1 and its porosity.
  • the three-dimensional percentage porosity of mesh 1 is preferably 87.8% (equivalent to a mean pore area of approximately 890 x 10 3 ⁇ m 2 ); however a value of between 80% and 95% imparts the desired physical and mechanical properties upon mesh 1.
  • three-dimensional percentage porosity of mesh 1 is meant the ratio between the volume of the voids and the total volume expressed as a percentage.
  • Mesh 1 used to construct the prosthesis according to the invention is marked by optimum stability which in addition to the structure of the mesh itself (in particular the diameter of the monofilaments and the configuration of pores 4a and 4b and knots 6, that is the type of weave), is also due to the presence of at least four threads 8a, 8b, 8c and 8d within each larger pore 4a of substantially hexagonal shape, as previously illustrated.
  • the stability of the mesh is meant its ability to remain substantially flat and not shrink; this property essentially derives from the fact that the mesh has resistance to deformation.
  • mesh 1 depends among other things on the configuration of pores 4a and 4b and knots 6.
  • Some mesh prostheses according to the prior art for example the abovementioned SoftMesh mesh, have rhombus-shaped pores with two threads passing through each pore, which has the disadvantage of rendering the mesh less stable.
  • thermofixing process which is a known process in the textile industry and is used to improve the dynamometric strength as well as the tear resistance and wear resistance of fabrics, as well as their thermal stability.
  • the said thermofixing process has the result that the course of the threads in the weave is stabilised, that is to say the compression forces at the points at which they cross are reduced, thus rendering the fabric more flexible and easier to handle.
  • thermofixed mesh tested had dimensions of 150.00 mm x 150.00 mm and provided the following results:
  • a mean porosity of 87.8 % corresponding to a mean pore area of 888.2 ⁇ m x 1000 ⁇ m (minimum pore area 14.9 ⁇ m x 1000 ⁇ m and maximum pore area of 2,814.6 ⁇ m x 1000 ⁇ m), the said porosity, expressed as a %, being determined on the basis of the mean mass per unit area (in g/m ), the mean thickness (in mm) and the filament density (0.92 g/cm ) by interpolation from 20 readings; the test was carried out using an ASM 68K image analyser interfaced with an Orthoplan optical microscope as the test instrumentation,
  • the test was carried out according to method ASTM D 1682/1964, using a CRE electronic dynamometer with a constant increase in elongation as the instrumentation, the initial distance being 100 mm, the width of the test specimen being 10 mm and the velocity of the cross-member being 50 mm/min, by interpolation from 2 test specimen, - a tear resistance in three directions according to Table 2 below (in which the longitudinal direction is the direction of the four threads 8a, 8b, 8c, 8d, identified in Figure 1 by arrow X):
  • test was carried out according to method UNI EN ISO 13937/2002, using a CRE electronic dynamometer with a constant increase in elongation as the test instrumentation, the initial distance being 25 mm, the dimensions of the test specimen, one in each direction, being 20 mm x 120 mm, and the velocity of the cross-member being 100 mm/min.
  • the prosthesis including mesh 1 according to the invention which has the abovementioned stability characteristics remains flat in the appropriate anatomical position and can therefore be positioned without sutures in accordance with tension-free sutureless hernia repair techniques.
  • This stability also makes the prosthesis easier to handle when it is being positioned anatomically, and the prosthesis can therefore be optimally positioned; stability then helps to hold the prosthesis in position over time and prevents it from shrinking and being displaced.
  • Figures 5 A and 5B show a diagrammatical plan view and a lateral view respectively of an embodiment of the prosthesis according to the invention in which the prosthesis is substantially shaped in the shape of a nail without a hole.
  • the dimensions of the said prosthesis are 45.00 mm x 100.00 mm, but may have any values up to 60.00 mm x 120 mm depending upon the envisaged application, the thickness of the mesh being preferably of any value between 0.59 mm and 0.78 mm.
  • Figures 6A and 6B show a diagrammatical plan view and a lateral view respectively of an embodiment in which the prosthesis is shaped in a substantially circular shape.
  • the diameter of this prosthesis is 7.00 mm, but it may be reduced down to 5.00 mm depending upon the envisaged application, the thickness of the mesh being preferably 0.59 mm.
  • Figures 7A and 7B show a diagrammatical plan view and a lateral view respectively of an embodiment in which the prosthesis is shaped in a substantially elliptical shape.
  • the dimensions of this prosthesis are 80.00 mm x 120.00 mm, but they may have any value up to 140.00 mm x 190 mm depending upon the envisaged application, the thickness of the mesh being preferably 0.80 mm.
  • Figures 8 A and 8B show a diagrammatical plan view and a lateral view respectively of an embodiment in which the prosthesis is shaped in a substantially square shape.
  • the sides of the said prosthesis are 150.00 mm, but may have any value up to 300.00 mm depending upon the envisaged application, the thickness of the mesh preferably having any value from 0.45 mm to 0.80 mm.
  • Figures 9A and 9B show a diagrammatical plan view and a lateral view respectively of an embodiment in which the prosthesis is shaped in a substantially rectangular shape.
  • the dimensions of the said prosthesis are 80.00 mm x 150.00 mm, but may have any value from 60.00 mm x 110.00 mm to 250.00 mm x 355.00 mm depending upon the envisaged application, the thickness of the mesh preferably having any value from 0.45 mm to 0.80.
  • mesh 1 may also be used to make three-dimensional prostheses.
  • three-dimensional prosthesis is meant a prosthesis made using mesh 1 provided with three dimensions during processing in order to obtain a medical device characterised by three dimensions.
  • the prosthesis incorporating mesh 1 in the various possible embodiments described above is particularly suitable for surgical use, in particular for hernioplasty and in particular using the tension-free and mpre specifically the tension-free sutureless hernia repair techniques, because it is very light and soft while having a stable behaviour which is similar to that of the heavy rigid meshes described in European Patent application no. EP 0 827 724 A2 cited above.
  • Table 3 provides a comparison between the properties of a prosthesis according to the present invention and that of other meshes according to the prior art and, in particular, the meshes described in European Patent application no. EP 0 827 724 A2, the SoftMesh meshes from BARD S. p. A. mentioned above and a standard type of mesh which is also marketed by BARD. S.p.A. which has a rigidity intermediate between the above, as well as meshes from other manufacturers such as BRAUN and FEG.
  • the data provided confirm that the mesh used in this invention has ultralightness, softness and macroporosity as well as stability characteristics which make it particularly suitable for surgical use as prostheses, specifically for hernioplasty.
  • the prosthesis according to the present invention constructed using mesh 1 has a tensile strength in the longitudinal direction which is less than that .of the heavy meshes but sufficient to guarantee repair of the defect in that it lies within the range of values from 16 to 32 N/cm which are regarded as physiological values in the literature.
  • the strength of the prosthesis according to this invention is approximately 30 N/cm. This value does not go beyond the range of physiological values, unlike heavy meshes in which the tensile strength in the longitudinal direction reaches values of around 80-100 N/cm.
  • the samples used for this measurement were preshaped meshes of dimensions 4.5 x 10 cm. Experimentally the prostheses were placed on a stable support and 1 cm of the mesh was attached thereto. The bend angle was measured from the horizontal direction clockwise
  • heavyweight mesh A is the most stable, having the least bend angle from the horizontal plane.
  • meshes B and C according to the invention although being ultra-lightweight, have because of their structure a bend angle which is not only less than that of the ultra-lightweight meshes according to the known art, but also than that of medium weight meshes.
  • the mesh constituting the prosthesis has only one type of pore, that is larger pores 4a, while smaller pores 4b are absent.
  • This embodiment is less preferred, at least at the present time, than the embodiment shown in Figure 1 characterised by two types of pores, that is larger pores 4a and smaller pores 4b.
  • non-slip properties brought about by greater roughness in at least one of the two surfaces of the mesh prosthesis, in order to improve its adhesion to the muscular wall.
  • These properties may be imparted by known means. More specifically, non-slip properties may be imparted to the mesh by the method of manufacture, which makes one of the two sides of the mesh rough.
  • this alternative embodiment will provide a right handed and a left handed prosthesis which can be more suitably used according to the type of application, more specifically the side, whether the right hand or left hand, on which the patient has to be operated.
  • - macroporosity has the effect of preventing the occurrence of infections following implantation of the prosthesis in the patient
  • the combination of softness and adequate stability makes handling the prosthesis easier for the surgeon and enables it to be positioned more accurately in its intended anatomical position, for easier repair of the hernia
  • the prosthesis including the woven mesh according to this invention has been designed for use as a prosthesis for hernioplasty, and more specifically for inguinal hernioplasty, and also for repairing and strengthening the abdominal wall and the inguinal region of the pelvic floor, and for the treatment of incontinence, but may however be validly applied in all those sectors of surgery, for example in gynaecology, which use tension-free or tension- free sutureless techniques.
  • the mesh may be coated with a film of resorbable and/or non-resorbable polymer material on one or both sides.
  • This film which generally has a thickness of between a few microns and a millimetre, may be attached to the mesh by welding, sewing or chemical and physical and/or thermal techniques.
  • non-resorbable films polypropylene films characterised by a specific microporosity likely to reduce problems caused by the occurrence of fistulas are preferably used.
  • resorbable films the use of polylactic acid (PLA) and polyethylene oxide (PEO) film obtained by solvent evaporation is preferred.
  • the prosthesis including the mesh for surgical use according to this invention is coated on at least one side with a coating network of fibres and nanofibres . of polymer material, the said fibres and nanofibres having a distribution of diameters within the range from 50 nanometres to 500 micrometres, preferably from 100 nanometres to 50 micrometres, as described in Italian patent application TO2007A000846 which is incorporated herein by reference.
  • the polymer materials which can be used to produce the fibre and nanofibre coating are materials capable of reducing and/or preventing adhesion and tissue erosion; reducing adhesion and bacterial growth and/or stimulating cell growth in a particular tissue.
  • materials capable of reducing and/or preventing adhesion and tissue erosion; reducing adhesion and bacterial growth and/or stimulating cell growth in a particular tissue include polyethylene glycol, chiosan, polyglycolic acid, polylactic acid, hyaluronic acid, polycaprolactone, polyethylene oxide and biological macromolecules (such as for example collagen, cellulose, gelatin).
  • PEO polyethylene oxide
  • PLA polylactic acid or lactic polyacid
  • PLA makes it possible to obtain fibres with better biological and mechanical properties and with a rate of resorption which is more compatible with physiological needs.
  • the network of fibres and nanofibres characterising this embodiment of the prosthesis according to the invention is obtained by the electrospinning technique.
  • Electrospinning is a technique which makes use of interactions of an electrostatic nature to excite tensile forces. This technique makes it possible to obtain thin fibres thanks to uniaxial stretching of a viscoelastic jet originating from a polymer solution (or spindle).
  • the diameter of the fibres obtained is reduced by the repulsions exerted by the charges present on the surface.
  • Elongation is obtained through a process in which traction is the result of the application of an electrical field, which involves the application of a high potential difference in order to induce the formation of a liquid jet comprising an extremely viscous polymer solution.
  • the jet is then held continuously under tension by the electrostatic repulsions exerted by the charges present on its surface, the solid fibre forms through evaporation of the solvent, which takes place in the section separating the needle from the collection plate.
  • the electrospinning equipment may comprise one or more linear nozzles or nozzles positioned on rotating rollers in such a way as to obtain continuous deposition.
  • the network of fibres and nanofibres obtained is also characterised by a porosity of between a few nanometres and one hundred micrometres, which allows biological fluids to pass through the network, preventing the occurrence of serositis and haematomas.
  • the fibre and nanofibre coating obtained by electrospinning also makes the prosthesis easier to handle in both open and laparoscopic surgery, and encourages its attachment using either adhesive or sutures, or other securing techniques.
  • the use of nanotechnological techniques of manufacture and the consequent production of a fibre coating having dimensions within the nanometric range makes it possible to improve the performance of the implanted prosthesis because the smaller quantity of material and the greater similarity to the environment and physiological conditions favour the biocompatibility of the device, consequently increasing the patient's comfort.
  • the smaller quantity of implanted material also reduces the risks arising from degradation products which, although biocompatible and able to be disposed of through physiological metabolism, nevertheless give rise to overburdening of the organs responsible for such disposal.
  • the following example relates to deposition by the electrospinning technique of a coating network of PLA/PEO fibres and nanofibres on the prosthesis including macroporous ultra- lightweight mesh 1 according to this invention.
  • This mesh is made of polypropylene and has the structure illustrated in Figure 1. The example is provided purely by way of • illustration.
  • a solution of PLA/PE.O at a concentration of 20% in acetone was prepared.
  • the ratio between the two PLA/PEO polymers by weight in the solution was 70/30.
  • Other solvents which do not compromise the biocompatibility of the final product may be used as an alternative to acetone. Examples of suitable alternative solvents are dimethyl sulphoxide, methylene chloride, dioxan and chloroform.
  • a network of fibres and nanofibres having a diameter of between 50 nanometres and tens of micrometres was obtained.
  • the increased weight of the mesh is very small in comparison with the values for commercially available meshes, which has made it possible to maintain the innovative concept of reducing the quantity of material used and a composite lightweight mesh.
  • the increase in weight of such meshes is indicatively between 0.1-10 mg per cm 2 .
  • Images (not shown) of the prosthesis coated with PLA/PEO by electrospinning as described above obtained using a scanning electron microscope (SEM) indicate that the PLA/PEO fibres/nanofibres are deposited on both the polypropylene thread and the porous areas, forming a continuous network.
  • the adhesion between the support (that is the mesh) and the network may be further improved by subjecting the product to heat treatments and/or chemical treatments and/or steam treatments.
  • the stability of the two or more components may be increased by welding, or by sewing the two or more parts.
  • the conditions described above may be varied.
  • the concentration of PLA/PEO in the solution may vary within the range from 5% to 50% by weight.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Textile Engineering (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

prothèse chirurgicale à toile tissée (1) pour utilisation chirurgicale reposant sur des techniques sans tension, de préférence une technique de suture sans tension, ce produit (1) combinant les propriétés physiques de douceur, d'ultralégèreté et de stabilité. Selon une variante, la prothèse à toile (1) est revêtue sur une ou deux surface d'un film en matériau polymère empêchant la survenue d'adhérences et/ou réduisant le phénomène de l'érosion. Selon une autre variante, la toile (1) est revêtue d'un réseau de fibres et de nanofibres polymères ayant une distribution de diamètres comprise dans la gamme allant de 50 nanomètres à 500 micromètres. Le réseau de revêtement de fibres et de nanofibres polymères est élaboré par électrofilature.
PCT/IT2007/000890 2006-12-20 2007-12-20 Prothèse chirurgicale à toile tissée pour utilisation chirurgicale et procédé de fabrication Ceased WO2008075398A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
ITTO20060908 ITTO20060908A1 (it) 2006-12-20 2006-12-20 Rete intessuta per uso chirurgico secondo tecniche "tension free", metodo per la sua realizzazione e protesi ottenute con detta rete.
ITTO2006A000908 2006-12-20
ITTO2007A000846 2007-11-23
ITTO20070846 ITTO20070846A1 (it) 2007-11-23 2007-11-23 Dispositivo protesico impiantabile con rivestimento in fibre e nanofibre e procedimento di fabbricazione

Publications (2)

Publication Number Publication Date
WO2008075398A2 true WO2008075398A2 (fr) 2008-06-26
WO2008075398A3 WO2008075398A3 (fr) 2009-02-12

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PCT/IT2007/000890 Ceased WO2008075398A2 (fr) 2006-12-20 2007-12-20 Prothèse chirurgicale à toile tissée pour utilisation chirurgicale et procédé de fabrication

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080241212A1 (en) * 2007-03-29 2008-10-02 Tyrx Pharma, Inc. Biodegradable, Polymer Coverings for Breast Implants
ITTO20100726A1 (it) * 2010-08-31 2012-03-01 Torino Politecnico Dispositivo protesico impiantabile e procedimento di solvent casting per la sua fabbricazione
WO2012158590A1 (fr) * 2011-05-13 2012-11-22 Atex Technologies, Inc. Tamis chirurgical avec pore stabilisé en dimensions
WO2017216609A1 (fr) * 2016-06-15 2017-12-21 Tubitak Timbre multifonctionnel pour hernie
US10188493B2 (en) 2011-05-13 2019-01-29 Atex Technologies, Inc. Surgical mesh with dimensionally stabilized pore
EP3653171A1 (fr) * 2018-11-16 2020-05-20 Sofradim Production Implants conçus pour la réparation de tissus mous

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE334639T1 (de) * 1999-06-08 2006-08-15 Ethicon Inc Chirurgische strickgewebe
DE10155842A1 (de) * 2001-11-14 2003-05-28 Ethicon Gmbh Flächiges Implantat
US8057841B2 (en) * 2004-02-12 2011-11-15 University Of Akron Mechanically attached medical device coatings

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080241212A1 (en) * 2007-03-29 2008-10-02 Tyrx Pharma, Inc. Biodegradable, Polymer Coverings for Breast Implants
US8911765B2 (en) * 2007-03-29 2014-12-16 Tyrx, Inc. Biodegradable, polymer coverings for breast implants
ITTO20100726A1 (it) * 2010-08-31 2012-03-01 Torino Politecnico Dispositivo protesico impiantabile e procedimento di solvent casting per la sua fabbricazione
WO2012029020A1 (fr) * 2010-08-31 2012-03-08 Politecnico Di Torino Dispositif prothétique implantable et procédé à coulée-évaporation pour sa fabrication
WO2012158590A1 (fr) * 2011-05-13 2012-11-22 Atex Technologies, Inc. Tamis chirurgical avec pore stabilisé en dimensions
US10188493B2 (en) 2011-05-13 2019-01-29 Atex Technologies, Inc. Surgical mesh with dimensionally stabilized pore
WO2017216609A1 (fr) * 2016-06-15 2017-12-21 Tubitak Timbre multifonctionnel pour hernie
JP2019517892A (ja) * 2016-06-15 2019-06-27 チュビタック （ターキー ビリムセル ヴィ テクノロジク アラスティルマ クルム）Ｔｕｂｉｔａｋ （Ｔｕｒｋｉｙｅ Ｂｉｌｉｍｓｅｌ Ｖｅ Ｔｅｋｎｏｌｏｊｉｋ Ａｒａｓｔｉｒｍａ Ｋｕｒｕｍｕ） 多機能ヘルニアパッチ
US20190321154A1 (en) * 2016-06-15 2019-10-24 Tubitak Multifunctional hernia patch
CN109789249B (zh) * 2016-06-15 2022-01-25 土耳其科学技术研究理事会 多功能疝气贴片
EP3653171A1 (fr) * 2018-11-16 2020-05-20 Sofradim Production Implants conçus pour la réparation de tissus mous
US11471257B2 (en) 2018-11-16 2022-10-18 Sofradim Production Implants suitable for soft tissue repair

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