WO2013007534A1 - Umbilical hernia prosthesis - Google Patents
Umbilical hernia prosthesis Download PDFInfo
- Publication number
- WO2013007534A1 WO2013007534A1 PCT/EP2012/062671 EP2012062671W WO2013007534A1 WO 2013007534 A1 WO2013007534 A1 WO 2013007534A1 EP 2012062671 W EP2012062671 W EP 2012062671W WO 2013007534 A1 WO2013007534 A1 WO 2013007534A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- prosthesis
- mesh
- tongues
- frame
- widened
- Prior art date
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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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00597—Implements comprising a membrane
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00623—Introducing or retrieving devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
- A61F2250/0031—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0097—Visible markings, e.g. indicia
Definitions
- the present invention provides a prosthesis, for repairing hernias, for example, comprising a mesh and a member for reinforcing the mesh.
- the abdominal wall consists of fat and muscles interconnected by aponeuroses.
- a break in continuity may occur at the level of the aponeuroses, allowing part of the peritoneum to pass through and form a sac, known as a hernia, containing either fat or a portion of the intestine.
- Hernias or ventral ruptures are manifested by a protrusion on the surface of the skin and are called umbilical or inguinal hernias or ventral ruptures, for example, as a function of their location.
- the efficacy of the prosthesis and thus minimizing the risk of relapse, depend to a great degree on the proper fixing of the prosthesis.
- the prosthesis before being fixed, the prosthesis must be correctly spread over the abdominal wall that it is intended to reinforce.
- Prostheses of mesh type i.e. based on an arrangement of threads forming a textile, are generally flexible, and to introduce them into the hernia they are often folded to reduce their volume. They therefore tend to form creases on the abdominal wall when they are introduced onto the implantation site. In this respect spreading them out is of primary importance but may prove difficult, in particular in the case of treating an umbilical hernia, which, being smaller than an inguinal hernia, offers little working space and little visibility for manipulation of the prosthesis by the surgeon.
- the size of the defect to be treated is small, for example from 1 to 4 cm diameter, and open surgery may be envisaged without widening the defect.
- the surgeon has little working space and little visibility. It would thus be preferable to have a prosthesis that is easy to position, to spread out and to fix, if possible avoiding the necessity for sutures at the periphery of the prosthesis, which is complicated and laborious under such working conditions.
- the present invention concerns a prosthesis that is adapted to be folded up in order to reduce the volume that it occupies at the time of its introduction into a small incision and on the other hand to be spread out and fixed easily so that the surgeon is sure of the perfect spreading of the prosthesis and that it may be fixed efficaciously at a certain distance between the centre of the prosthesis and its periphery without sutures at the periphery of the prosthesis and this, despite the little intrinsic visibility of small size hernias.
- the prosthesis of the invention is beneficial for treating hernias of the abdominal wall, in particular for treating umbilical hernias where the defect is small.
- a first aspect of the present invention provides a prosthesis comprising:
- said reinforcing member takes the form of a frame fastened to said mesh and substantially adopting the shape of said peripheral exterior edge of the mesh, said frame being set back from said peripheral exterior edge and being provided with two hinge points, the line passing through said two hinge points also passing through the centre of the mesh and thus forming a line for folding the mesh in two.
- the reinforcing member or frame may be rig id or have some flexibility. According to the present invention, the mesh and thus the prosthesis can be folded in two because of the presence of the two hinge points of the frame, regardless of the presence or not of intrinsic elastic properties of the frame.
- the term "mesh” refers to an arrangement of biocompatible threads, for example a knitted, woven or non- woven material, preferably of the openwork kind, i.e. having pores encouraging tissue recolonization.
- a mesh may be bioresorbable, partly bioresorbable or permanent. It is sufficiently flexible to be folded up at the time of its introduction into the abdominal cavity.
- the mesh may be produced from one layer of textile or from a plurality of layers of textiles. Such meshes are well known to the person skilled in the art.
- the mesh usable for the invention may be supplied in any shape (rectangular, square, circular, oval, etc.) and then cut to match the shape of the hernia defect.
- the mesh may have the overall shape of a disc or an oval: in this case the frame also has a circular or oval shape and is preferably in the form of a ring.
- the mesh may have a globally square or rectangular shape: in this case the frame also has a square or rectangular shape.
- the frame is set back from the exterior peripheral edge of the mesh: thus, whilst adopting the shape of the contour of the mesh, the frame has an exterior perimeter smaller than that of the exterior peripheral edge of the mesh : in other words, the exterior peripheral edge of the mesh extends a certain distance beyond the frame. This distance may be greater than or equal to 1 mm, for example.
- the frame and the exterior peripheral edge of the mesh are of similar geometric shape but the frame shows dimensions which are less than that of the exterior peripheral edge of the mesh.
- the shape of the frame and its location, set back slightly from the exterior peripheral edge of the mesh enable the surgeon, when implanting the prosthesis, to fix it to the peritoneum efficaciously without requiring sutures at the periphery of the mesh: the surgeon is able to fix the prosthesis along the interior contour of the frame only, said interior contour defining a stitches fixing line: this avoids the surgeon having to apply stitches to the prosthesis at the exterior peripheral edge of the mesh, which is difficult to reach and hardly visible because of the small size of the incision.
- the interior contour of the frame of the prosthesis of the invention defines a fixing line, or stitching line, located approximately half way between the centre of the mesh and its exterior peripheral edge, along wh ich the surgeon may locate the stitches when he fixes the prosthesis to the abdominal wall. Nevertheless, perfect spreading out of the prosthesis is assured by the presence of the frame wh ich, by adopting the shape of the contour of the exterior peripheral edge, ensures deployment of the prosthesis and pressing thereof onto the abdominal wall.
- the mesh is a knitted fabric: because of the stitches that form it, a knitted fabric makes it possible to obtain openwork faces encouraging cellular recolonization after implantation .
- the knitted fabric may be a two-dimensional knitted fabric or a three-dimensional knitted fabric.
- two- dimensional knitted fabric means a knitted fabric having two opposite faces linked together by stitches but having no spacers imparting a certain thickness to it: such a knitted fabric may be obtained, for example, by knitting threads on a warp or Raschel knitting machine using two guide bars. Examples of two- dimensional knitted fabrics suitable for the present invention are given in the document WO2009/071998.
- three-dimensional knitted fabric means a knitted fabric having two opposite faces linked together by spacers imparting a significant thickness to the knitted fabric, said spacers consisting of connecting threads additional to the threads forming the two faces of the knitted fabric.
- Such a knitted fabric may be obtained, for example, using a double-bed Raschel knitting machine or warp knitting machine with a plurality of guide bars.
- said frame is set back from the exterior peripheral edge and is of serpentine shape, forming undulations.
- said frame is in the form of a flat ribbon forming undulations substantially in the plane of said mesh .
- this configuration of the frame makes it possible, when fixing the prosthesis to the biological tissue, to execute a suture in the prosthesis at a g iven location without deforming th e prosthesis as a whole during th is operation; deformation of the prosthesis caused by the suture at the given location is smoothed out by the undulating frame.
- the frame and therefore the rest of the prosthesis remain correctly positioned, and in particular remain pressed against the abdominal wall, during the fixing of the prosthesis.
- the frame preferably possesses a certain rigidity along its section.
- said reinforcing member is produced in bioresorbable material.
- the reinforcing member fulfils its role of stiffening the prosthesis during positioning and implantation of the prosthesis and is then degraded progressively once the mesh is recolonized by the surrounding cells.
- the bioresorbable material may be chosen, for example, from polylactic acid (PLA), polycaprolactone (PCL), polyd ioxanone (PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoate (PHA), oxidized cellulose, polyglycol acid (PGA), copolymers of these materials and mixtures thereof.
- PLA polylactic acid
- PCL polycaprolactone
- PDO polyd ioxanone
- TMC trimethylene carbonate
- PVA polyvinyl alcohol
- PHA polyhydroxyalkanoate
- oxidized cellulose polyglycol acid (PGA), copolymers of these materials and mixtures thereof.
- the reinforci ng mem ber is prod uced in a non- bioresorbable material chosen from polypropylene, a polyester such as polyethylene terephthalate, polyamide, silicone, polyetheretherketone (PEEK), polyaryletheretherketone (PAEK) and mixtures thereof.
- a non- bioresorbable material chosen from polypropylene, a polyester such as polyethylene terephthalate, polyamide, silicone, polyetheretherketone (PEEK), polyaryletheretherketone (PAEK) and mixtures thereof.
- said reinforcing member is produced from a combination of bioresorbable material and non-bioresorbable material.
- said tongues have a globally rectangular shape and are provided at one of their ends with a widened part by which they are fixed to said mesh.
- the tongues are useful to the surgeon by facilitating positioning of the prosthesis at the centre of the defect to be treated and for fixing the prosthesis to the biological tissue.
- said tongues are textile tongues.
- the textile of the tongues may be identical to that of the mesh or different.
- the tongues may be made of bioresorbable material or not.
- a suitable bioresorbable material for the manufacturing of the tongues may be selected from bioresorbable materials mentioned above for the reinforcing member.
- the widened part being separate from the rest of the tongue, said widened part is produced in gripping textile and can thus be attached to and/or detached from the rest of the tongue at will.
- gripping textile examples of production of gripping textile are described in the document WO0181667.
- the widened part of the tongues may be sewn to said mesh.
- the widened part enables better fixing of the tongues to the mesh.
- the widened part of the tongues is fixed to the mesh by means of the reinforcing member.
- said two tongues are fixed on either side of said folding line, preferably at two places symmetrical about this folding line.
- said mesh has the shape of a disc, said frame being substantially in the form of a circular ring, and said tongues are fixed to two diametrically opposed places on said ring, said two places being spaced by 90° from each of said two hinge points.
- the face of the mesh including said two tongues may be provided with two additional tongues fixed to the mesh at the locations of the two hinge points of the ring.
- the tongues is of a colour different from that of the mesh : for example, the widened parts of the tongues may be of a colour different from that of the mesh.
- the colour difference between the widened parts of the tongues, or the whole tongues, and the mesh is particularly advantageous in view of the little visibility offered by the small size of the working area : this colour difference allows defining a line, said line pointing out to the surgeon where to complete the stitches for fixing the prosthesis to the abdominal wall.
- said mesh being disc-shaped and said frame being substantially in the form of a circular ring
- said prosthesis comprises four of said tongues, the widened parts of which being of a colour different from that of the mesh, said four widened parts being distributed along an interior contour of said ring, symmetrically with respect to said folding line M, two of said widened parts on one side of said folding line M, the other two of said widened parts on the other side of said folding line M.
- all four widened parts are under the form of isosceles triangles of textile, each triangle being fixed to said mesh via its base, all four triangles showing identical elongation and tensile strength properties in the centripetal direction.
- each isosceles triangle is fixed to the mesh via its base by means of the ring, the rectangular part of the tongue being attached to the vertex angle of the isosceles triangle. Because of the four isosceles triangles of textile having the same mechanical properties in the centripetal direction, when the surgeon pulls on the rectangular parts of the four tongues at the time he puts the prosthesis in place and fixes it to the abdominal wall, all widened parts of the tongues react similarly and the traction exerted by the surgeon on the whole prosthesis via the four tongues is regularly distributed. The prosthesis is therefore properly positioned.
- the surgeon readily identifies the stitching line as defined above and the step of fixing the prosthesis to the abdominal wall is facilitated.
- the method of manufacturing a prosthesis with four widened parts under the form of four isosceles triangle of textile having identical mechanical properties is simple and easy.
- the free ends of the tongues are joined together by a centring thread.
- a centring thread Such a configuration enables the surgeon to use the centring thread to position and fix the prosthesis particularly easily and effectively when implanting the prosthesis, as will become apparent from the description given below.
- the face of the mesh opposite that including said tongues is covered with a non-adherent coating.
- Such a coating makes it possible in particular to avoid the formation of unwanted severe post-operative fibrous adhesions.
- nonadherent refers to a non-porous, smooth, biocompatible coating or material offering no space for cellular recolonization and preferably encouraging the birth of a peritoneum.
- Figure 1 is a representation in section of a median abdominal hernia or ventral rupture
- Figure 2 is a simplified view of the hernia from Figure 1 after the surgeon has made an abdominal incision and removed the hernia sac,
- F igu re 3 is a top view of one embod iment of a mesh for a prosthesis of the invention
- Figure 4 is a top view of a reinforcing member for the prosthesis of the invention
- Figure 5 is a top view of a tongue of the prosthesis of the invention.
- Figure 6 is a top view of the mesh and the reinforcing member of the prosthesis of the invention.
- Figure 7A is a top view of the mesh, the reinforcing member and a tongue of the prosthesis of the invention
- Figure 7B is a view of the prosthesis from Figure 7A when a second tongue has been fitted
- Figure 8A is a top view of the prosthesis of the invention.
- Figure 8B is a perspective view of a variant of the prosthesis of the invention.
- Figure 9 is a simplified sectional view of the introduction of the prosthesis from Figure 8B into the hernia defect
- Figure 10A is a simplified sectional view of the positioning of the prosthesis from Figure 8B after deployment thereof at the implantation site
- Figure 10B is a simplified sectional view of the fixing of the prosthesis from Figure 8B,
- Figure 1 1 is a view in section of the prosthesis from Figure 8B when fixed to the biological tissues just before closure of the abdominal incision by the surgeon,
- Figure 12 is a top view of an embodiment of the prosthesis of the invention with two tongues
- Figure 13 is a simplified sectional view of the placement of a prosthesis of the invention using the tongues from Figure 12,
- Figure 1 4-1 7 are top views showing the successive steps of a method for manufacturing a prosthesis of the invention comprising four widened parts of textile having identical mechanical properties.
- Figure 1 represents a hernia defect 100 of the abdominal wall 101 that is characterized by a break in the continu ity of the aponeurosis 1 02 surrounding the straight muscles 1 03 and a passage through the peritoneum 104 forming a sac, the hernia sac 105, that contains either fat (epiploon) or part of the viscera 106, and which then presses on the fatty tissues 107 and is flush with the skin 108.
- One treatment of a hernia defect 100 entails replacing and retaining the viscera 106 in the abdominal cavity 109.
- Figu re 2 shows the hern ia defect 100 from Figure 1 after the surgeon has made an incision in the skin 108, the abdominal wall 101 and the peritoneum 104 and has reduced the hernia sac.
- the viscera are not shown in Figure 2: they have been pushed back into the abdominal cavity 109.
- the surgeon must now introduce into the abdominal cavity 109, via the incision 1 10 that has been made, a prosthesis for reinforcing the abdominal wall, before closing the incision 1 1 0 by means of sutures, for example.
- the size of the incision 1 10 is particularly small, for example of the order of 1 to 4 cm diameter.
- Figure 3 represents a mesh 1 in the form of a disc usable with the reinforcing member from Figure 4 and tongues such as that from Figure 5 to produce a prosthesis of the invention.
- Th e m e s h 1 i s m a d e fro m a knitted, woven or non-woven arrangement of biocompatible threads. It may be bioresorbable, partly bioresorbable or permanent.
- the mesh is generally openwork, incorporating pores for better tissue integration .
- This mesh 1 is sufficiently flexible to be folded when the prosthesis is introduced into the abdominal cavity 109 via the incision 1 1 0.
- the mesh is generally a textile having no elasticity enabling it to return to a spread out configuration of its own accord after it has been folded up.
- the mesh 1 may be produced from a textile layer or a plurality of textile layers.
- the textile may be a two-dimensional or three-dimensional knitted fabric.
- the mesh may be supplied in the form of a strip that is cut to the dimensions of the defect to be treated .
- the mesh 1 has the shape of a disc adapted to the shape of the incision 1 10 at the hernia defect 1 00 and delimited by an exterior peripheral edge 1 a.
- the mesh may be of oval shape.
- the mesh may be of rectangular or square shape.
- Figure 4 represents a reinforcing member of a prosthesis of the invention, suitable for the shape of the mesh 1 from Figure 3: as is apparent from Figure 4 and Figure 6, the reinforcing member takes the form of a frame 2 substantially adopting the shape of the exterior peripheral edge 1 a of the mesh 1 .
- the overal l shape of the frame 2 is a circular ring .
- the frame 2 is provided with two hinge points 3a and 3b that are diametrically opposite in the example shown .
- the two h inge points (3a, 3b) make it possible to fold the frame 2, for example when force is appl ied by the surgeon, resulting in two globally identical parts.
- the hinge points (3a, 3b) preferably do not have any elasticity of their own : thus, once folded in two, the frame 2 can be unfolded only by the action of an external force, for example exerted by the surgeon.
- the frame 2 thus consists of two parts, namely two semicircles 2a and 2b, connected together by two hinge points (3a, 3b).
- the respective ends (2c; 2d) of the sem icircles 2a and 2b are bl unted or rounded to prevent trauma when implanting the prosthesis.
- the two semicircles 2a and 2b are symmetrical : the two hinge points (3a; 3b) define a med ian l ine M passing through the centre of the circle delimited by the frame and also through the centre of the mesh 1 when the frame 2 is fixed to the mesh 1 , as shown in Figure 6.
- the mesh 1 may be folded in two even when fitted with the frame 2: consequently, as will become apparent in the remainder of the description , the prosthesis may be folded .
- the prosthesis is able to adopt only two configurations: either a flat and spread out configuration or a folded in two configuration .
- the fact that the prosthesis can adopt only two configurations facil itates the task of the surgeon , who can immediately determine if the prosthesis is in its spread out configuration or not.
- the frame 2 is an undulating ring set back from the exterior peripheral edge 1 a , consisting of undulations 4.
- the exterior peripheral edge 1 a of the mesh extends some distance beyond the exterior contou r of the frame 2 : th is distance may be greater than or equal to 1 mm, for example.
- the location of the frame 2, slightly set back from the exterior peripheral edge 1 a facilitates efficacious fixing of the prosthesis to the abdominal wall, in particular in an area located more or less half way between the centre and the edge of the mesh.
- the undulations 4 of the frame 2 may be regular or not.
- the frame 2 is in the form of a flat ribbon of material forming undulations 4 in the plane of the frame 2, which is substantially the plane of the prosthesis.
- such a shape imparts to the frame 2 great flexibility in the plane of the frame 2 and thus in the plane of the prosthesis: it is thus possible to suture part of the prosthesis at a g iven place, without rocking or deforming the prosthesis as a whole: the deformation created at the location of the suture is smoothed out by the u nd ulations 4 of the frame 2 over the whole of the periphery of the prosthesis.
- the frame 2 shows a rigidity along its section, so that it neither deforms rad ially in the outward nor in the inward directions.
- Materials suitable for producing the reinforcing member of the prosthesis of the invention may be any biocompatible materials having some rigidity so as to respond to the expectations disclosed above.
- the frame 2 can thus be produced in any biocompatible material, bioresorbable or not. In a preferred embodiment, it is made in bioresorbable material .
- bioresorbable refers to the characteristic whereby a material is absorbed by biolog ical tissues and disappears in vivo after a given period, which may vary from one day to several months, for example, depending on the chemical nature of the material.
- Bioresorbable materials suitable for the fabrication of the reinforcing member of the prosthesis of the present invention include polylactic acid (PLA), polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), polyhydroxyal kanoate (PHA), oxid ized cellulose, polyglycolic acid (PGA), copolymers of these materials and mixtures thereof.
- Bioresorbable materials suitable for the fabrication of the reinforcing member of the prosthesis of the i nvention incl ude polyester (g lycol id , d ioxa none, trimethylene carbonate) available from the company Covidien under the trade name "B IOSYN®” and polyester (g lycolid, caprolactone, trimethylene carbonate, lactid) available commercially from the company Covidien under the trade name "CAPROSYN®".
- Non-bioresorbable materials suitable for the fabrication of the rei nforci ng mem ber of the prosth es is of th e present i nvention include polypropylene, polyesters such as polyethylene terephthalate, polyamide, silicone, polyetheretherketone (PEEK), polyaryletheretherketone (PAEK) and mixtures thereof.
- Each part of the reinforcing member of the prosthesis of the invention may be made in one piece, for example, by injection moulding one or more biocompatible thermoplastic or thermosetting materials.
- the hinge points (3a, 3b) of the frame 2 may be produced in the same material as the rest of the frame: these h inge points (3a, 3b) ta ke the form for example of very th in bridges of material in order to enable folding of the frame 2 without causing separation of the two parts joined together by these bridges.
- Figure 5 shows a tongue 5 suitable for the prosthesis of the invention.
- the tongue 5 has a globally rectangular part 6 and a widened part 7 situated at one end 6a of the rectangular part 6, said end 6a forming a junction between the rectangular part 6 and the widened part 7.
- the widened part 7 has a trapezoidal overall shape with a circular arc base 7a: as may be seen in Figures 7A and 7B, the widened part 7 of each tongue 5 is intended to be fixed to the mesh 1 , for example by means of the frame 2.
- the widened part 7 of the tongue 5 may be sewn to the mesh along a seam 7b as shown in Figure 7A.
- the free end 6b of the rectangular part 6 may be joined to the free ends of the other tongues 5, as shown in Figure 8B.
- the free ends 6b of the tongues may be joined during fabrication of the prosthesis or at the time of implantation by the surgeon .
- the length of the rectangular part 6 must be sufficient to enable joining of the tongues 5: nevertheless, this length must not be too great in order not to impede the surgeon at the time of implanting the prosthesis.
- the length of the rectangular part 6 is preferably from 2 to 6 cm and more preferably from 2 to 4 cm.
- the tongue 5 is made in one piece.
- the widened part and the rectangular part may be two separate parts that are assembled before use. In such a case, the two parts may be in d ifferent materials.
- the tongue 5 may be produced in any biocompatible material imparting to it the flexibility necessary for it to be picked up by the surgeon during fitting of the prosthesis, as described hereinafter.
- the tongues 5 are intended to assist the surgeon to position the prosthesis relative to the hernia and then to fix it to the abdominal wall.
- the tongue 5 is in textile.
- This textile may be identical to that forming the mesh 1 or different.
- the widened part and the rectangular part are two initially separate parts, the widened part for example may consist of a gripping textile as described in WO0181 667 and the rectangular part may consist of an openwork textile stuck to the widened part.
- the tongues may be realized in a bioresorbable material, for example such as that described above for the reinforcing member.
- FIG 8A shows a prosthesis 200 of the invention made with the mesh 1 from Figure 3, the frame 2 from Figure 4 and four tongues 5 from Figure 5.
- the prosthesis of the invention has only two tongues: in such a case, the two tongues are preferably fixed on either side of the folding line M, for example by means of the reinforcing member.
- the four tongues 5 are arranged symmetrically around the ring formed by the frame 2 in order to balance each other.
- two of the tongues 5 are fixed to two diametrically opposite places 8 and 8a of the frame 2, said two places being each spaced by 90° from the hinge points 3a and 3b.
- Two other tongues 5 are fixed at the locations of the two hinge points 3a and 3b.
- Each tongue 5 is fixed to the mesh 1 by its widened part 7, the circular arc parts of the widened parts of the tongues 5 being adjacent in pairs.
- the centre 1 b of the mesh 1 is moreover provided with a centring thread 13. This centring thread is intended to be grasped by the surgeon when fitting the prosthesis 200 on the implantation site.
- the centring thread 13 is long enough to enable the surgeon to manipulate it outside the body of the patient with the prosthesis 200 inside the body of the patient.
- the presence of the four tongues 5, regularly distributed as described above, and the centring thread 13 enables the surgeon to balance the tension between the various tongues at the time of positioning the prosthesis and to centre the latter prosthesis better relative to the defect to be closed.
- the reinforcing member namely the frame 2 in the example shown, is welded directly to the mesh 1 and to the circular arc parts 7a of the four tongues 5.
- the frame 2 is fastened both to the mesh 1 and to the widened parts 7 of the tongues 5.
- the prosthesis 200 is thus substantially contained in a plane comprising the mesh 1 , the frame 2 and the widened parts 7 of the tongues 5.
- the centring thread 13 is not fixed to the centre of the mesh 1 but joins the free ends 6b of the four tongues 5. This centring thread 1 3 may then be placed by the surgeon before implanting the prosthesis 200. In th is embodiment, the centring thread 13 may pass through the tongues 5 or simply surround them to hold them together without passing through them.
- the face of the mesh 1 opposite that including the tongues 5 is covered by a non-adherent coating 201 .
- a nonadherent coating makes it possible to avoid in particular the formation of unwanted severe post-operative fibrous adhesions; once the prosthesis 200 has been implanted , the face of the prosthesis 200 covered by the non- adherent coating 201 faces the abdominal cavity 109.
- the non-adherent coating or material is chosen from bioresorbable materials, n o n-bioresorbable materials and mixtures thereof.
- the non- bioresorbable non-adherent m a t e r i a l s m a y b e c h o s e n f r o m polytetrafluoroethylene, polyethylene glycol, polysiloxane, polyurethane, and mixtures thereof.
- bioresorbable materials suitable for said non-adherent coating may be chosen from collagen , oxid ized cel l ulose, polyacrylate, trimethylene carbonate, caprol acton e , d ioxa none , g lycol ic acid , l actic acid , g lycol ide , l actid e , polysaccaride, for example chitosan, polyglucuronic acid, hyaluronic acid, dextran and mixtures thereof.
- the non-adherent coating makes it possible to protect the mesh 1 of the prosthesis 200 at least during the initial scar formation phase, i.e. the mesh 1 is not exposed to inflammatory cells, such as granulocytes, monocytes, macrophages or the giant multinucleated cells generally activated by surgery. At least during the initial scar formation phase, the duration of which may vary from a bou t 5 days to about 10 days, only the non-adherent coating is accessible to the various factors such as proteins, enzymes, cytokines or inflammatory cells.
- the non-adherent coating consists of non-resorbable materials, it thus protects the mesh 1 before and after implantation and throughout the duration of implantation of the prosthesis 200.
- surrounding fragile tissues such as the hollow viscera, for example, are protected, in particular from unwanted severe post-operative fibrous adhesion.
- the non-adherent material includes a bioresorbable material
- the prosthesis 200 of the invention may adopt a folded configuration after the surgeon folds it along the folding line M.
- the surgeon folds it in two so that it occupies a smaller volume, which facilitates introduction of the prosthesis into the hernia defect 100 (see Figure 2) by the surgeon.
- Th e mesh 1 a nd the non-adherent coating 201 are sufficiently flexible to follow successive deformations of the prosthesis 200 as the latter is introduced to the implantation site.
- F ig u res 1 4-17 describe various steps of a method for manufacturing an embodiment of a prosthesis 21 0 of the invention made with the mesh 1 of Figure 3, the frame 2 of Figure 4 and four widened parts 207, made separately from the rectangular parts of the tongues.
- the rectangular parts of the tongues are not shown on Figures 14-17 : these rectangular parts are similar to the rectangular part 6 of tongue 5 of Figure 5 and may be either integrate with the widened parts 217 or else attached to said widened parts 217 by any fixation means such as sewing, welding, gluing or by means of a gripping textile.
- the four widened parts 21 7 of prosthesis 210 are arranged symmetrically along the interior contour of the ring formed by the frame 2, and they al l have the same mechan ical properties.
- a textile 20 for forming the widened parts 21 7 of tongues of the prosthesis 21 0 is shown a textile 20 for forming the widened parts 21 7 of tongues of the prosthesis 21 0 (see Figure 1 7).
- the textile 20 has the shape of a square, the length of one side of the square being greater than the greater diameter of the intended resulting prosthesis 210.
- This textile 20 may be identical to that forming the mesh 1 or different.
- the textile 20 is for example produced on a knitting machine and has a warp direction Wa and a weft direction We, as shown on this Figure 14.
- the textile 20 may have different mechanical properties, such as elongation and tensile strength, along its warp direction Wa and along its weft direction We.
- the textile 20 has a colour different from that of the mesh 1 .
- a cutting 21 having the shape of a cross with two perpendicular branches (22, 23) is completed on textile 20, with one branch 22 of the cross parallel to the warp direction Wa and the other branch 23 of the cross parallel to the weft direction We, as shown on Figure 15.
- the branches of the cross may be of identical lengths or not. On the example shown on Figure 1 5, the length of the branch 22 parallel to the warp direction Wa is smaller than the length of the branch 23 paral lel to the weft d irection .
- the length of the branch 22 parallel to the warp direction Wa is smaller than the diameter of the internal perimeter of the frame 2, whereas the length of the branch 23 parallel to the weft direction is greater than the diameter of the outer perimeter of the frame 2.
- the textile 20 is laid upon a piece of mesh 1 , for example of similar square shape and dimensions as the textile 20, and the frame 2 of Figure 4 is then welded to both the mesh 1 and the textile 20.
- the frame 2 is welded on mesh 1 and textile 20 so that the greater branch 23 of the cutting 21 is appl ied on the folding line M defined by the frame 2 (see Figure 4) and extends beyond the h inge points (3a, 3b) of the frame 2, whereas the smaller branch 22 of the cutting 21 does not reach the frame 2.
- Such an embod iment allows a better efficiency of the frame 2, wh ich may not be damaged by residual filaments coming from the cutting of branch 22 when said frame 2 is welded on both the mesh 1 and the textile 20.
- the disc-shape prosthesis 210 may be manufactured by cutting the mesh 1 and textile 20 in excess beyond the outer peripheral border of the frame 2, as shown on Figure 17. As appears from this Figu re, the frame 2 forms together with the cross-shaped cutting 21 four isosceles triangles 24, more or less fixed to the frame 2 by their respective base 24a and free at their vertex angle 24b. These four isosceles triangles 24 of textile 20 form the widened parts 21 7 of the tongues (not shown) of the prosthesis 210.
- a rectangular part such as rectangular part 6 of tongue 5 of figure 5 may then be attached to the free vertex angle 24b of each triangle 24 by any fixation means such as sewing, welding, gluing or by means of a gripping textile, in line with the direction defined by the altitude 24c drawn from the vertex angle 24b of each triangle 24.
- the altitude direction or centripetal direction for each triangle 24 forms an angle of 45° with respect to both warp and weft directions of the initial textile 20.
- al l fou r widened parts 21 7 show the same mechanical properties, in particular elongation properties and tensile strength properties, in the direction corresponding to the direction of the altitude 24c of each triangle 24, in other words in the direction of the rectangular part of the tongue (not shown) corresponding to the direction of the traction exerted by the surgeon when he puts the prosthesis in place and fixes it to the abdominal wall .
- the method of manufacturing the prosthesis 210 described above is very s im pl e a nd al lows starting from a s ing l e p iece of texti l e 20 for manufacturing the four widened parts 217.
- the prosthesis 210 may be manufactured by preparing initially four separate triangles 24 of textile 20 and welding each triangle 24 to the mesh 1 via the frame 2, or alternatively by preparing two pieces of semi- discs of textile 20, completing a perpendicular cutting on each semi-disc and welding the two cut semi-discs to the mesh via the frame 2.
- the prosthesis 210 of Figure 17 may be provided with a centring thread 13 and may be coated on the face of the mesh 1 opposite that including the widened parts 217 with a non-adherent coating 201 .
- the surgeon grasps the prosthesis 200 from Figure 8B, covered with a nonadherent coating 201 on the face of the mesh 1 opposite that includ ing the tongues 5, and applies force to the prosthesis 200 with his fingers to fold it along the folding line M . Because of the presence of the two hinge points 3a and 3b, this operation is without difficulty and totally independent of the elastic or non-elastic nature of the frame 2.
- the prosthesis 200 being a d isc, it is folded along one of its d iameters, resulting in two identical parts.
- the prosthesis 200 occupies a small volume and the surgeon may easily introduce it into the abdominal cavity 1 09, as shown in Figure 9, while holding the centring thread 13 outside the body of the patient.
- the fingers of the surgeon are not represented in Figures 9 to 1 1 .
- the surgeon releases the pressure on it. It is the surgeon who manually deploys the prosthesis 200 in a perfectly tensioned and spread out configuration.
- the prosthesis 200 being able to adopt only two positions, namely folded in two or spread out, the surgeon is certain that the prosthesis is perfectly spread out from the moment of unfolding the prosthesis 200.
- the surgeon uses the centring thread 13 both to centre the prosthesis 200 relative to the incision 1 10 and to press the prosthesis 200 against the abdominal wall (101 , 104). To this end, the surgeon pulls the centring thread 13 toward the exterior of the body of the patient. Thus the prosthesis 200 is spread perfectly and there is no risk of the viscera being disposed between the widened parts 7 of the tongues 5 and the abdominal wall (101 , 104).
- the surgeon raises a part of the edge of the hernia and thus uncovers a central area 12 in the vicinity of the prosthesis 200, del im ited overall by the widened parts 7 of the tongues 5, wh ich area the surgeon may easily view and in which the surgeon is able to work easily.
- the widened parts 7 of the tongues 5 or the tongues 5 as a whole may be a different colour than the mesh 1 , in order to facilitate viewing of the central working area 12 by the surgeon .
- the colour difference between the widened parts 7 of the tongues, or the whole tongues 5, and the mesh 1 defines a l ine, said l ine pointing out to the surgeon where to complete the stitches for fixing the prosthesis 200 to the abdominal wall .
- This fixing line, or stitching line globally corresponds to the interior contour of the frame 2.
- the surgeon proceeds to fix the prosthesis 200 to the biological tissues by using a needle 9 and a suture 10 to suture the enlarged part 7 of each tongue 5 to the abdominal wall 101 , 1 04 within the central working area 12.
- the whole of the prosthesis 200 remains perfectly spread out and perfectly pressed onto the abdominal wall 1 04, notably by virtue of the presence of the undulations 4 of the frame 2, which smooth out deformations caused by the surgeon in the area of the prosthesis 200 that is in the process of being sutured.
- the surgeon may execute one or more stitches 1 1 (see Figure 1 1 ) for each enlarged part 7 of the four tongues 5.
- the structure of the prosthesis 200 of the invention enables the surgeon to place the stitches 1 1 in an area situated between the centre of the mesh 1 and the exterior peripheral edge 1 a thereof; this area is in particular located at the level of the interior contour of the frame 2 : thus the surgeon does not have to execute stitches at the exterior peripheral edge of the mesh 1 , which can be viewed only with difficulty because of the smal l size of the incision 1 1 0.
- the mesh 1 nevertheless remains perfectly pressed against the abdominal wall 104 along this peripheral edge 1 a because of the presence of the frame 2.
- the stitches 1 1 are advantageously situated at some distance from the defect, in particular in an area more or less in the middle between the centre 1 b of the mesh (which is the location of the hernia defect) and the peripheral exterior edge 1 a of the mesh, at a location where the biological tissues are often healthier and less fragile than at the margin of the defect.
- the stitches 1 1 may for example be U-shaped, i.e. obtained with a thread provided with a needle at each of its ends.
- each tongue 5 is cut approximately at the junction 6a between its widened part 7 and its rectangular part 6 in order to retain at the implantation site only the widened portion 7, as shown in Figure 1 1 .
- This figure shows the stitches 1 1 that fix the widened parts 7 of the tongues 5 to the abdominal wall 1 04.
- the prosthesis 200 is thus perfectly deployed, spread out and pressed against the abdominal wall (1 01 , 1 04) with no risk of trapping viscera between the prosthesis 200 and the abdominal wall (101 , 104).
- Th e su rg eon th en h as on ly to close the incision 1 10 in the conventional way for small size hernias, i.e. by stitches.
- the rectangular parts 6 of the tongues 5 cannot impede the surgeon because they have advantageously been cut off and removed beforehand.
- FIG 12 shows a variant of an embodiment of the tongues of the prosthesis of the invention.
- two opposed tongues 5 may be produced from a single rectangular piece of textile 14 provided at its two ends with two widened parts 7.
- the part 14 is fixed to the mesh 1 by the widened parts 7 as explained above for the embodiment of Figures 1 to 1 1 .
- a second piece 1 4 of textile is fixed to the mesh 1 , perpendicularly to the first piece.
- a centring thread may be passed through the centres of the two textile parts 1 4.
- the prosthesis of the invention is particularly simple to install, the surgeon being easily able to uncover a comfortable working area, despite the restricted size of the implantation site.
- the fitting of the prosthesis of the invention is also particularly rel iable, all risk of trapping the viscera being avoided .
- a prosthesis of the invention is particularly su itable for treating umbilical hernias where the abdominal incision made is of smal l size.
- the prosthesis of the invention is adapted to adopt a configuration in wh ich it occu pies a particu larly smal l vol ume facil itating its introduction into the abdominal cavity via a small incision without necessitating the use of any dedicated ancillary device.
- the prosthesis of the invention may be spread out and pressed onto the abdom in al wal l efficaciously, also without necessitating the use of a dedicated tool to assist spreading it and with no risk of reversion of the prosthesis.
- the prosthesis of the invention thus makes it possible to treat a hernia, in particular an umbilical hernia, efficaciously, simply and rapidly, minimizing the risk of relapse.
Abstract
Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2014519493A JP6049218B2 (en) | 2011-07-13 | 2012-06-29 | Artery for umbilical hernia |
AU2012283292A AU2012283292B2 (en) | 2011-07-13 | 2012-06-29 | Umbilical hernia prosthesis |
CN201280034741.0A CN103764068B (en) | 2011-07-13 | 2012-06-29 | Umbilical hernia dummy |
CA2841339A CA2841339C (en) | 2011-07-13 | 2012-06-29 | Umbilical hernia prosthesis |
US14/232,390 US9622843B2 (en) | 2011-07-13 | 2012-06-29 | Umbilical hernia prosthesis |
EP12733645.1A EP2731547B1 (en) | 2011-07-13 | 2012-06-29 | Umbilical hernia prosthesis |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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FR11/56426 | 2011-07-13 | ||
FR1156426A FR2977790B1 (en) | 2011-07-13 | 2011-07-13 | PROSTHETIC FOR UMBILIC HERNIA |
Publications (1)
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WO2013007534A1 true WO2013007534A1 (en) | 2013-01-17 |
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Application Number | Title | Priority Date | Filing Date |
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PCT/EP2012/062671 WO2013007534A1 (en) | 2011-07-13 | 2012-06-29 | Umbilical hernia prosthesis |
Country Status (8)
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US (1) | US9622843B2 (en) |
EP (1) | EP2731547B1 (en) |
JP (1) | JP6049218B2 (en) |
CN (1) | CN103764068B (en) |
AU (1) | AU2012283292B2 (en) |
CA (1) | CA2841339C (en) |
FR (1) | FR2977790B1 (en) |
WO (1) | WO2013007534A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
CA2841339C (en) | 2019-02-12 |
FR2977790B1 (en) | 2013-07-19 |
CA2841339A1 (en) | 2013-01-17 |
US20140194926A1 (en) | 2014-07-10 |
US9622843B2 (en) | 2017-04-18 |
EP2731547A1 (en) | 2014-05-21 |
AU2012283292B2 (en) | 2016-08-11 |
AU2012283292A1 (en) | 2014-01-16 |
EP2731547B1 (en) | 2015-07-08 |
CN103764068A (en) | 2014-04-30 |
CN103764068B (en) | 2016-02-10 |
JP2014523325A (en) | 2014-09-11 |
JP6049218B2 (en) | 2016-12-21 |
FR2977790A1 (en) | 2013-01-18 |
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