WO1996003091A1 - Surgical product and its use - Google Patents

Surgical product and its use Download PDF

Info

Publication number
WO1996003091A1
WO1996003091A1 PCT/GB1995/001786 GB9501786W WO9603091A1 WO 1996003091 A1 WO1996003091 A1 WO 1996003091A1 GB 9501786 W GB9501786 W GB 9501786W WO 9603091 A1 WO9603091 A1 WO 9603091A1
Authority
WO
WIPO (PCT)
Prior art keywords
mesh
surgical
integral
substantially uniform
tissue
Prior art date
Application number
PCT/GB1995/001786
Other languages
French (fr)
Other versions
WO1996003091B1 (en
Inventor
Mitchell James Notaras
Original Assignee
Mitchell James Notaras
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mitchell James Notaras filed Critical Mitchell James Notaras
Priority to AU31194/95A priority Critical patent/AU3119495A/en
Publication of WO1996003091A1 publication Critical patent/WO1996003091A1/en
Publication of WO1996003091B1 publication Critical patent/WO1996003091B1/en

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Classifications

    • 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
    • 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

Definitions

  • This invention relates to a surgical mesh/net implant/prosthesis and to its use in hernia repair and abdominal wall reinforcement.
  • a hernia develops as a weakness or hole in the abdominal wall, and the mesh is used to patch it and reinforce the surrounding tissue while healing takes place.
  • the mesh is sandwiched between layers of tissue and initially lies in a thin layer of fluids known as a sero a which it produces after insertion. If uninfected, and healing proceeds normally, the mesh becomes incorporated in the host tissue. The host's surrounding tissue grows through the interstices (holes) of the mesh and becomes scar tissue completely enveloping it. This scar tissue will contract.
  • the mesh provides a permanent scaffolding, strengthening the abdominal wall against forces which predispose the tissue to hernia formation.
  • Known synthetic meshes for hernia repair are woven or knitted. They are made of multi-strand filament or fibre yarn, e.g. surgipro (US Surgical) , Mersilene (Ethicon) and expanded PTFE (Gore-Tex) , or monofilament material, e.g. Prolene (Ethicon) and Marlex (Bard) . Thus, they have knots or loops at crossover/intersection points.
  • PTFE is a microporous structure consisting of solid nodes of PTFE interconnected by thin fibrils.
  • EP-A-0096458 describes an apertured elastic film comprising a blend of polyurethane and a polymer, for external bodily contact only, and which would normally have an absorbent dressing backing to mop up any exudations from a wound. It cannot be used internally, as a prosthesis or implant for hernia repair, as it is too fragile, having insufficient tensile strength for stitching, and would not contribute to the reinforcement of the wound repair.
  • the film is paper-thin and easily tears. Polyurethane is banned for internal use in the body as it degrades into carcinogenic compounds.
  • the present invention minimises this fibrous reaction (scar tissue formation) , and thus minimises the Oppenhei er effect.
  • One object behind this invention is therefore to eliminate any potential dead space, no matter how small, from the structure of the mesh.
  • Mesh sandwiched between the host tissues in the early stages must be a "thin filling" between it and the host tissues, to minimise the dead space between the layers.
  • Woven meshes, as a result of the tight weave, are thickened due to the knots and/or filament loops at crossover points, and this helps to increase the volume in three dimensions occupied by the sandwiched mesh and hence the potential for dead space and increased fibrotic reaction.
  • a product of this invention is preferably a pliable, monofilament, unwoven, and knotless integral mesh or net- like structure of strands of uniform solid thickness. It has a structure of monofilament mesh or netting with solid intersections (no knots or loops) , thus leaving no micro ⁇ spaces in the construction/structure of the mesh (or net) for bacteria to enter.
  • the solid intersections may have a slight increased crossover thickness relative to the strands.
  • the design is such that there is no fraying of the edges or weakening of the mesh when cut to fit the space in which it is to be placed, as there are no knots to loosen. This ensures suture or staple fixation does not tear out from the edges. Its knotless and monofilament construction results in its being less thick than woven meshes, and therefore decreases the space occupied by the mesh.
  • the integral mesh or interconnecting net-like structure may be opaque or coloured.
  • Most synthetic meshes now marketed are transparent, and when used endoscopically make it more difficult to allow stable placement under direct vision during laparoscopic hernia repair, with the possible risk of vascular and nerve injury.
  • the mesh may be formed by, for example, a conventional moulding or extrusion process. It may also be made in a number of other ways to achieve the same result, an integral mesh.
  • the synthetic material may be in a sheet form and mechanically or hydraulically stamped to product the mesh pattern.
  • Another form of synthetic sheet cutting to produce any desirable mesh is by laser cutting.
  • Yet another method is by extrusion and simultaneous slitting of the mesh openings so that the mesh may also be expandable and compliant.
  • Another advantage of the integral mesh is that, regardless of the mesh size, or mesh opening, the stable solid points of intersection remain small.
  • Pore size may be determined according to the use of the mesh for a particular operation. It may be above 100 ⁇ m (i.e. above typical prior art product pore sizes), e.g. from 0.5 to 10 mm, preferably 1.5 to 4 mm.
  • the strength, thickness and porosity of the integral mesh may be modified to suit the designated operative procedure. A determinant is the forces it is required to resist. A common use is for abdominal and chest wall defects.
  • the mesh material thickness may be, for example, from 0.05 to 2 mm.
  • the integral mesh of the invention may be made of any pliable solid synthetic material which is inert to the body. It must have sufficient strand tensile strength, e.g. with a strand thickness down to 0.05 mm, for the purpose designated. Examples are nylon or other polyamide, polypropylene, polyester and carbon fibre or the like. More generally, the material composition may be any suitable plastics or other material which has the designated characteristics, e.g. those that have previously been proposed for hernia repair.
  • mesh or net is used herein to define a fabric of crossing filaments or strands with open spaces between them.
  • the angle of intersection is not critical. For example, it may be about 90°C, in which case the ratio of the open area: area occupied by the filaments in the plane of the mesh is maximised.
  • extruded plastics materials were selected, of substantially uniform thickness, and as illustrated in the accompanying drawings.
  • the pore sizes were 3 mm (Fig. 1) and ? (Fig. 2) .
  • the filament (and also fabric) thicknesses were ? (Fig. 1) and ? (Fig. 2) .
  • a surgical product according to the invention may be introduced in conventional manner. Its primary characteristic is that its construction/structure is adapted to reduce problems associated with human implantation, such as bacterial infection and contracture due to fibrous encapsulation.

Abstract

A product, for surgical use, in the form of an open, integral mesh of substantially uniform thickness.

Description

SURGICAL PRODUCT AND ITS USE Field of the Invention
This invention relates to a surgical mesh/net implant/prosthesis and to its use in hernia repair and abdominal wall reinforcement. Background of the Invention
It is well known that various synthetic surgical meshes have been used in hernia repair operations. A hernia develops as a weakness or hole in the abdominal wall, and the mesh is used to patch it and reinforce the surrounding tissue while healing takes place. The mesh is sandwiched between layers of tissue and initially lies in a thin layer of fluids known as a sero a which it produces after insertion. If uninfected, and healing proceeds normally, the mesh becomes incorporated in the host tissue. The host's surrounding tissue grows through the interstices (holes) of the mesh and becomes scar tissue completely enveloping it. This scar tissue will contract. The mesh provides a permanent scaffolding, strengthening the abdominal wall against forces which predispose the tissue to hernia formation.
Known synthetic meshes for hernia repair are woven or knitted. They are made of multi-strand filament or fibre yarn, e.g. surgipro (US Surgical) , Mersilene (Ethicon) and expanded PTFE (Gore-Tex) , or monofilament material, e.g. Prolene (Ethicon) and Marlex (Bard) . Thus, they have knots or loops at crossover/intersection points. PTFE is a microporous structure consisting of solid nodes of PTFE interconnected by thin fibrils.
Amid et al, Postgraduate General Surgery 4(2):150-155 (1992) , discuss various "bio aterials" that may be suitable for use in the repair of groin hernia. In particular, the use of synthetic mesh materials, e.g. made of polypropylene (Marlex or Prolene) or polyester (e.g. sold as Mersilene, made by Ethicon, or Dacron®) , is illustrated, each mesh being of the type comprising knots at the points of intersection of the mesh filaments.
EP-A-0096458 describes an apertured elastic film comprising a blend of polyurethane and a polymer, for external bodily contact only, and which would normally have an absorbent dressing backing to mop up any exudations from a wound. It cannot be used internally, as a prosthesis or implant for hernia repair, as it is too fragile, having insufficient tensile strength for stitching, and would not contribute to the reinforcement of the wound repair. The film is paper-thin and easily tears. Polyurethane is banned for internal use in the body as it degrades into carcinogenic compounds. Summary of the Invention It has now been appreciated that known meshes for hernia repair predispose the patient to infection and sinus tract formation (a constant discharge of pus through an opening through an opening in the skin) , and that this is due to the presence of micro-spaces between the constituent filaments in braided yarn material and at knot or loop crossover points. Bacteria, averaging 1 μ in size, are able to enter into such small spaces and proliferate. They are protected from neutrophilic granulocytes (white blood cells averaging 10-15 μm in size) which would normally immobilise and phagocytose (destroy) the bacteria, as they are too big to enter these micro-spaces. In other words, these spaces remain large enough to permit bacterial access ("wicking") , harbour bacteria, and even encourage their multiplication between the material filaments. Further, it has now been appreciated that, by comparison with known meshes, the amount (volume and surface area) of foreign body material required to cover a given area can be reduced. The physiological reaction to a foreign body is directly proportional to the surface area of the material with which it is in contact, and its chemical structure. For the relatively inert biomaterials used for implantation, the reaction will depend on the surface area of the foreign body. Any reduction of surface area will therefore decrease this reaction which is an inflammatory fibrous reaction leading to scar tissue which eventually envelops the mesh. With time, the scar tissue contracts, leading to contraction and crinkling of the mesh which may affect the area it is meant to cover. The present invention minimises this fibrous reaction (scar tissue formation) , and thus minimises the Oppenhei er effect. One object behind this invention is therefore to eliminate any potential dead space, no matter how small, from the structure of the mesh. Mesh sandwiched between the host tissues in the early stages must be a "thin filling" between it and the host tissues, to minimise the dead space between the layers. Woven meshes, as a result of the tight weave, are thickened due to the knots and/or filament loops at crossover points, and this helps to increase the volume in three dimensions occupied by the sandwiched mesh and hence the potential for dead space and increased fibrotic reaction.
These and other desirable advantages are simply achieved, according to the invention, by a surgical product in the form of an open, integral mesh of substantially uniform thickness. Such products are known, but not in the context of this invention, i.e. for surgical use and especially for hernia repair. Description of the Invention
A product of this invention is preferably a pliable, monofilament, unwoven, and knotless integral mesh or net- like structure of strands of uniform solid thickness. It has a structure of monofilament mesh or netting with solid intersections (no knots or loops) , thus leaving no micro¬ spaces in the construction/structure of the mesh (or net) for bacteria to enter. The solid intersections may have a slight increased crossover thickness relative to the strands. The design is such that there is no fraying of the edges or weakening of the mesh when cut to fit the space in which it is to be placed, as there are no knots to loosen. This ensures suture or staple fixation does not tear out from the edges. Its knotless and monofilament construction results in its being less thick than woven meshes, and therefore decreases the space occupied by the mesh.
The integral mesh or interconnecting net-like structure may be opaque or coloured. Most synthetic meshes now marketed are transparent, and when used endoscopically make it more difficult to allow stable placement under direct vision during laparoscopic hernia repair, with the possible risk of vascular and nerve injury.
The mesh may be formed by, for example, a conventional moulding or extrusion process. It may also be made in a number of other ways to achieve the same result, an integral mesh. For example, the synthetic material may be in a sheet form and mechanically or hydraulically stamped to product the mesh pattern. Another form of synthetic sheet cutting to produce any desirable mesh is by laser cutting. Yet another method is by extrusion and simultaneous slitting of the mesh openings so that the mesh may also be expandable and compliant.
Another advantage of the integral mesh is that, regardless of the mesh size, or mesh opening, the stable solid points of intersection remain small.
Pore size may be determined according to the use of the mesh for a particular operation. It may be above 100 μm (i.e. above typical prior art product pore sizes), e.g. from 0.5 to 10 mm, preferably 1.5 to 4 mm. The thinner the strand material and the bigger the pore size, the more the integral mesh is expandable in different directions; this is an advantage in hernia repair, in that the mesh will move with the musculature, thus reducing tension in the repair which is the usual source of post-operative pain and discomfort. The greater the pore size, the easier it is for the host tissue to infiltrate the interstices. The strength, thickness and porosity of the integral mesh may be modified to suit the designated operative procedure. A determinant is the forces it is required to resist. A common use is for abdominal and chest wall defects. The mesh material thickness may be, for example, from 0.05 to 2 mm.
The integral mesh of the invention may be made of any pliable solid synthetic material which is inert to the body. It must have sufficient strand tensile strength, e.g. with a strand thickness down to 0.05 mm, for the purpose designated. Examples are nylon or other polyamide, polypropylene, polyester and carbon fibre or the like. More generally, the material composition may be any suitable plastics or other material which has the designated characteristics, e.g. those that have previously been proposed for hernia repair.
The term mesh or net is used herein to define a fabric of crossing filaments or strands with open spaces between them. The angle of intersection is not critical. For example, it may be about 90°C, in which case the ratio of the open area: area occupied by the filaments in the plane of the mesh is maximised.
In specific embodiments of the invention, extruded plastics materials were selected, of substantially uniform thickness, and as illustrated in the accompanying drawings. The pore sizes were 3 mm (Fig. 1) and ? (Fig. 2) . The filament (and also fabric) thicknesses were ? (Fig. 1) and ? (Fig. 2) . These products are suitable for successful use in hernia repair. A surgical product according to the invention may be introduced in conventional manner. Its primary characteristic is that its construction/structure is adapted to reduce problems associated with human implantation, such as bacterial infection and contracture due to fibrous encapsulation.

Claims

1. A product, for surgical use, in the form of an open, integral mesh of substantially uniform thickness.
2. A surgical product according to claim 1, which is 0.1 to 2 mm thick.
3. A surgical product according to claim 1 or claim 2, having a substantially uniform pore size, of 0.5 to 10 mm.
4. A method for hernia repair, which comprises introducing into the affected tissue of a patient a reinforcing mesh through which the tissue grows, wherein the reinforcing mesh is in the form of an open, integral mesh of substantially uniform thickness.
PCT/GB1995/001786 1994-07-27 1995-07-26 Surgical product and its use WO1996003091A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU31194/95A AU3119495A (en) 1994-07-27 1995-07-26 Surgical product and its use

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9415125A GB9415125D0 (en) 1994-07-27 1994-07-27 Surgical product and its use
GB9415125.5 1994-07-27

Publications (2)

Publication Number Publication Date
WO1996003091A1 true WO1996003091A1 (en) 1996-02-08
WO1996003091B1 WO1996003091B1 (en) 1996-02-29

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WO (1) WO1996003091A1 (en)

Cited By (69)

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US6113641A (en) * 1997-08-27 2000-09-05 Ethicon, Inc. Prosthesis for the obturation of a hernial canal
US6180848B1 (en) 1997-08-27 2001-01-30 Ethicon, Inc. Prosthesis obturating device for the obturation of a hernial canal
WO2001015625A1 (en) * 1999-08-31 2001-03-08 Ethicon Gmbh Reinforced areal implant
US6241768B1 (en) 1997-08-27 2001-06-05 Ethicon, Inc. Prosthetic device for the repair of a hernia
FR2807936A1 (en) 2000-04-20 2001-10-26 Sofradim Production ABDOMINAL WALL REINFORCEMENT FOR THE TREATMENT OF INGUINAL HERNIA BY ANTERIOR VOLTAGE-FREE
FR2807937A1 (en) 2000-04-20 2001-10-26 Sofradim Production Self-gripping prosthesis of knitted fabric for parietal reinforcement has outer monofilament layer with loops broken by fusion to make spikes
WO2001089390A1 (en) * 2000-05-19 2001-11-29 Genzyme Corporation Device for delivery of surgical materials
WO2002078568A1 (en) * 2001-03-30 2002-10-10 Mpathy Medical Devices Limited Surgical implant
US6723133B1 (en) 1998-09-11 2004-04-20 C. R. Bard, Inc. Performed curved prosthesis having a reduced incidence of developing wrinkles or folds
US6740122B1 (en) 1998-09-11 2004-05-25 C. R. Bard, Inc. Preformed curved prosthesis that is adapted to the external iliac vessels
EP1565125A1 (en) * 2002-11-15 2005-08-24 Carey Tasca Pty Ltd. Method of surgical repair of vagina damaged by pelvic organ prolapse and prosthetic materials and devices suitable for use therein
WO2005082274A1 (en) * 2004-02-26 2005-09-09 Gfe Medizintechnik Gmbh Hernia net for treating inguinal or hiatus hernias
WO2005117747A1 (en) * 2003-11-20 2005-12-15 Schubert Medical Gmbh I.Gr. Reinforcement mat for hiatus hernia operations
US7900484B2 (en) 2006-10-19 2011-03-08 C.R. Bard, Inc. Prosthetic repair fabric
US8118728B2 (en) 2000-10-12 2012-02-21 Coloplast A/S Method for implanting an adjustable surgical implant for treating urinary incontinence
US8123671B2 (en) 2005-08-04 2012-02-28 C.R. Bard, Inc. Pelvic implant systems and methods
US8128554B2 (en) 2000-10-12 2012-03-06 Coloplast A/S System for introducing a pelvic implant
US8147478B2 (en) 2000-09-07 2012-04-03 Ams Research Corporation Coated sling material
US8215310B2 (en) 2004-05-21 2012-07-10 Coloplast A/S Implant for treatment of vaginal and/or uterine prolapse
US8317808B2 (en) 2008-02-18 2012-11-27 Covidien Lp Device and method for rolling and inserting a prosthetic patch into a body cavity
US8480559B2 (en) 2006-09-13 2013-07-09 C. R. Bard, Inc. Urethral support system
WO2013128434A1 (en) 2012-02-28 2013-09-06 Incorpracyl Technologies Ltd. Tissue support structure
US8574149B2 (en) 2007-11-13 2013-11-05 C. R. Bard, Inc. Adjustable tissue support member
US8668635B2 (en) 2000-10-12 2014-03-11 Coloplast A/S Pelvic implant with suspending system
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
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US8906045B2 (en) 2009-08-17 2014-12-09 Covidien Lp Articulating patch deployment device and method of use
US8920304B2 (en) 2000-07-05 2014-12-30 Coloplast A/S Method and device for treating urinary incontinence
US9005222B2 (en) 2002-08-02 2015-04-14 Coloplast A/S Self-anchoring sling and introducer system
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
US9186489B2 (en) 2003-03-27 2015-11-17 Coloplast A/S Implantable delivery device system for delivery of a medicament to a bladder
US9242026B2 (en) 2008-06-27 2016-01-26 Sofradim Production Biosynthetic implant for soft tissue repair
US9301826B2 (en) 2008-02-18 2016-04-05 Covidien Lp Lock bar spring and clip for implant deployment device
US9308068B2 (en) 2007-12-03 2016-04-12 Sofradim Production Implant for parastomal hernia
US9393002B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
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US9445883B2 (en) 2011-12-29 2016-09-20 Sofradim Production Barbed prosthetic knit and hernia repair mesh made therefrom as well as process for making said prosthetic knit
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US10865505B2 (en) 2009-09-04 2020-12-15 Sofradim Production Gripping fabric coated with a bioresorbable impenetrable layer
US10900153B2 (en) 2017-05-02 2021-01-26 Sofradim Production Two-sides gripping knit
US11413129B2 (en) 2020-06-19 2022-08-16 Davol Inc. Implantable prosthesis
US11471257B2 (en) 2018-11-16 2022-10-18 Sofradim Production Implants suitable for soft tissue repair
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Cited By (153)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6113641A (en) * 1997-08-27 2000-09-05 Ethicon, Inc. Prosthesis for the obturation of a hernial canal
US6180848B1 (en) 1997-08-27 2001-01-30 Ethicon, Inc. Prosthesis obturating device for the obturation of a hernial canal
US6241768B1 (en) 1997-08-27 2001-06-05 Ethicon, Inc. Prosthetic device for the repair of a hernia
US6740122B1 (en) 1998-09-11 2004-05-25 C. R. Bard, Inc. Preformed curved prosthesis that is adapted to the external iliac vessels
US6723133B1 (en) 1998-09-11 2004-04-20 C. R. Bard, Inc. Performed curved prosthesis having a reduced incidence of developing wrinkles or folds
WO2001015625A1 (en) * 1999-08-31 2001-03-08 Ethicon Gmbh Reinforced areal implant
US6966918B1 (en) 1999-08-31 2005-11-22 Ethicon G.M.B.H. Reinforced areal implant
US6596002B2 (en) 2000-04-20 2003-07-22 Sofradim Production Abdominal wall reinforcement for the treatment of inguinal hernias by an anterior route
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