Medical device

Abstract

A soft tissue implant comprises a condensed surgical mesh having a plurality of monofilament biocompatible fibres 12 . Condensing of the fibres reduces the void space between adjacent fibres 12 in the mesh and reduces the surface area of the fibres 12 available for contact with tissue 18 . Condensation of the fibres 12 may be achieved by applying mechanical pressure, and/or vacuum, and/or heat to the mesh.

1 . A soft tissue implant comprising a condensed surgical mesh, the mesh comprising one or more biocompatible fibres, at least one of the fibres comprising a monofilament fibre.  
   
   
       2 . An implant as claimed in  claim 1  wherein each fibre in the mesh comprises a monofilament fibre.  
   
   
       3 . An implant as claimed in  claim 1  wherein along at least part of at least one fibre, the fibre is condensed.  
   
   
       4 . An implant as claimed in  claim 3  wherein the mesh has a void space between adjacent fibres in the mesh, and along the condensed part of the fibre, the mesh void space is reduced.  
   
   
       5 . An implant as claimed in  claim 3  wherein along the condensed part of the fibre:  
     
       
         
           
             
               
                 A 
                 v 
               
               
                 A 
                 F 
               
             
             ≤ 
             1.5 
           
         
       
     
     where: 
 A V =area of the void between adjacent fibres in the mesh available for tissue infiltration.  
 A F =cross-sectional area of the fibre.  
 
   
   
       6 . An implant as claimed in  claim 3  wherein along the condensed part of the fibre, the surface area of the fibre available for contact with tissue is reduced.  
   
   
       7 . An implant as claimed in  claim 6  wherein along the condensed part of the fibre:  
     
       
         
           
             
               
                 P 
                 FC 
               
               
                 P 
                 F 
               
             
             ≤ 
             0.8 
           
         
       
     
     where: 
 P FC =Perimeter of the fibre, at a cross-section of the fibre, which is available for contact with tissue.  
 P F =Total perimeter of the fibre, at a cross-section of the fibre.  
 
   
   
       8 . An implant as claimed in  claim 1  wherein the fibres are condensed at at least some points of intersection between the fibres.  
   
   
       9 . An implant as claimed in  claim 1  wherein the fibres are at least partially flattened at at least some points of intersection between the fibres.  
   
   
       10 . An implant as claimed in  claim 1  wherein the mesh has at least one overlap region, at which at least one fibre overlaps at least one other fibre, at least one of the fibres being condensed at the overlap region.  
   
   
       11 . An implant as claimed in  claim 10  wherein at the overlap region, one fibre is fused with an overlapping fibre.  
   
   
       12 . An implant as claimed in  claim 10  wherein at the overlap region, one fibre engages with an overlapping fibre.  
   
   
       13 . An implant as claimed in  claim 12  wherein the engagement of one fibre with an overlapping fibre substantially prevents in-growth of tissue between the overlapping fibres.  
   
   
       14 . An implant as claimed in  claim 10  wherein the overlapping fibres are condensed together.  
   
   
       15 . An implant as claimed in  claim 1  wherein the fibre comprises a polymer and/or a copolymer.  
   
   
       16 . An implant as claimed in  claim 1  wherein the fibre comprises polypropylene.  
   
   
       17 . An implant as claimed in  claim 1  wherein the mesh is condensed substantially uniformly.  
   
   
       18 . An implant as claimed in  claim 1  wherein the mesh comprises a condensed region and an uncondensed region.  
   
   
       19 . An implant as claimed in  claim 1  wherein the mesh comprises at least two regions which are differentially condensed.  
   
   
       20 . An implant as claimed in  claim 1  wherein the implant is configured for attachment to tissue.  
   
   
       21 . An implant as claimed in  claim 20  wherein the implant is configured to facilitate coupling of an attachment element to the mesh.  
   
   
       22 . An implant as claimed in  claim 21  wherein the attachment point comprises an attachment opening in the mesh to receive an attachment element, such as a suture, and/or a staple, and/or an adhesive.  
   
   
       23 . An implant as claimed in  claim 20  wherein the mesh comprises one or more engagement formations for attachment of the mesh to tissue.  
   
   
       24 . An implant as claimed in  claim 23  wherein the mesh comprises a plurality of protrusions configured in a wave-like or dimple like pattern.  
   
   
       25 . An implant as claimed in  claim 1  wherein at least part of the mesh is treated to increase the coefficient of friction of the mesh.  
   
   
       26 . An implant as claimed in  claim 1  wherein the mesh is configured to maintain the position of the mesh relative to tissue.  
   
   
       27 . An implant as claimed in  claim 26  wherein the mesh comprises one or more engagement formations for engaging tissue.  
   
   
       28 . An implant as claimed in  claim 1  wherein at least a portion of the mesh is of a composite configuration.  
   
   
       29 . An implant as claimed in  claim 18  wherein the implant comprises an inelastic element to reinforce the mesh.  
   
   
       30 . An implant as claimed in  claim 29  wherein the inelastic element is woven into the mesh.  
   
   
       31 . An implant as claimed in  claim 29  wherein the inelastic element is attached to a surface of the mesh.  
   
   
       32 . An implant as claimed in  claim 1  wherein the thickness of at least part of the mesh is in the range of from 0.001 inches to 0.04 inches.  
   
   
       33 . An implant as claimed in  claim 1  wherein the thickness of the mesh is substantially constant across the mesh.  
   
   
       34 . An implant as claimed in  claim 1  wherein the thickness of the mesh varies across the mesh.  
   
   
       35 . An implant as claimed in  claim 1  wherein the density of at least part of the mesh is greater than 0.081 g/cm 3 .  
   
   
       36 . An implant as claimed in claims  1  wherein the density of the mesh is substantially constant across the mesh.  
   
   
       37 . An implant as claimed in  claim 1  wherein the density of the mesh varies across the mesh.  
   
   
       38 . An implant as claimed in  claim 1  wherein the mesh pore size is uniform across the mesh.  
   
   
       39 . An implant as claimed in  claim 1  wherein the mesh pore size varies across the mesh.  
   
   
       40 . An implant as claimed in  claim 1  wherein the implant comprises a three dimensional structure.  
   
   
       41 . An implant as claimed in  claim 1  wherein at least some of the mechanical properties of the mesh are substantially omnidirectional.  
   
   
       42 . A method of forming a surgical mesh, comprising one or more biocompatible fibres, at least one of the fibres comprising a monofilament fibre, the method comprising the step of condensing at least part of the mesh.  
   
   
       43 . A method as claimed in  claim 42  wherein each fibre in the mesh comprises a monofilament fibre.  
   
   
       44 . A method as claimed in  claim 42  wherein the mesh is condensed by applying heat to at least part of the mesh.  
   
   
       45 . A method as claimed in  claim 42  wherein the mesh is condensed by applying pressure to at least part of the mesh.  
   
   
       46 . A method as claimed in claims  42  wherein the mesh is condensed by applying a vacuum to at least part of the mesh.  
   
   
       47 . A method as claimed in  claim 42  wherein the method comprises the step of heat-setting the mesh.  
   
   
       48 . A method as claimed in  claim 42  wherein the method comprises the step of controlling the texture of the mesh.  
   
   
       49 . A method as claimed in  claim 48  wherein the texture is controlled by arranging the mesh in contact with a control surface before the step of condensing is performed.  
   
   
       50 . A method as claimed in  claim 49  wherein the method comprises the step of maintaining the temperature of the control surface substantially stable.  
   
   
       51 . A method as claimed in  claim 49  wherein the method comprises the step of maintaining the pressure of the control surface substantially stable.  
   
   
       52 . A method as claimed in  claim 42  wherein the method comprises the step of forming the mesh into a three-dimensional structure.  
   
   
       53 . A method as claimed in  claim 42  wherein the method comprises the step of treating the mesh to make at least some of the mechanical properties of the mesh substantially omnidirectional.  
   
   
       54 . A method of making a soft tissue implant, the method comprising: 
 (c) providing a surgical mesh; and    (d) condensing the surgical mesh to generate-material useful as a soft tissue implant    
   
   
       55 . The method of  claim 54 , further comprising altering the size or shape of the material to generate the soft tissue implant.  
   
   
       56 . The method of  claim 54 , wherein providing the surgical mesh comprises extruding a biocompatible polymer or copolymer into a fibre and forming the surgical mesh from the fibre.  
   
   
       57 . The method of  claim 56  wherein the biocompatible polymer or copolymer is a non-absorbable polymer or copolymer.  
   
   
       58 . The method of  claim 57  wherein the non-absorbable polymer is a polymer of polypropylene, polyethylene, polyethylene terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon, fluorinated ethylene propylene, polybutester, or silicone, or a copolymer thereof.  
   
   
       59 . The method of  claim 58 , wherein the biocompatible polymer or copolymer is an absorbable polymer.  
   
   
       60 . The method of  claim 59 , wherein the absorbable polymer is a polymer of polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone, polydioxanone or polyhydroxyalkanoate, or a copolymer thereof.  
   
   
       61 . The method of  claim 60 , wherein the biocompatible polymer is collagen or a copolymer comprising collagen.  
   
   
       62 . The method of  claim 57 , wherein forming the surgical mesh comprises knitting the fibre.  
   
   
       63 . The method of  claim 54  wherein the mesh comprises pores of a substantially uniform size.  
   
   
       64 . The method of  claim 54  wherein the mesh comprises pores that are greater than 50 micrometers in diameter.  
   
   
       65 . The method of  claim 54  wherein condensing the surgical mesh comprises applying pressure and, optionally, heat to the mesh.  
   
   
       66 . The method of  claim 65  wherein the pressure or heat is applied for a time and under conditions sufficient to reduce the void space within the mesh.  
   
   
       67 . The method of  claim 65  wherein the pressure or heat is applied for a time and under conditions sufficient to reduce the surface area available for contact with a patient's tissue.  
   
   
       68 . The method of  claim 66 , wherein the pressure or heat is applied to the mesh uniformly.  
   
   
       69 . The method of  claim 66  wherein the pressure or heat is applied to the mesh non-uniformly.  
   
   
       70 . The method of  claim 65  wherein the pressure or heat is applied to the mesh while the mesh is under vacuum.  
   
   
       71 . The method of  claim 54  further comprising inserting, into the material, an opening for receiving an attachment element.  
   
   
       72 . The method of  claim 54  wherein the material is about 0.001-0.040 inches thick.  
   
   
       73 . The method of  claim 54  wherein the material is of a size and shape appropriate for stabilizing or supporting the bladder neck, urethra, pelvic floor, or abdominal wall.  
   
   
       74 . The method of  claim 54  further comprising fashioning the material into a tubular or conical shape.  
   
   
       75 . A soft tissue implant made by the method of  claim 54 .  
   
   
       76 . A method of making a soft tissue implant, the method comprising: 
 (d) providing a surgical mesh;    (e) condensing the surgical mesh by applying pressure and, optionally, heat to the mesh, wherein the pressure and, optionally, the heat, is applied for a time and under conditions sufficient to reduce the void space within the mesh; and    (f) cleaning or sterilizing the mesh, thereby generating material useful as a soft tissue implant.    
   
   
       77 . A soft tissue implant comprising a woven or knit monofilament mesh having a density greater than 0.081 g/cm 3 , the space between the monofilament mesh constituting pores of about 500 μm to about 10 mm in diameter.