EP2983613A1 - Implantierbare verstärkungsprothese, insbesondere zur verstärkung der bauchdecke - Google Patents

Implantierbare verstärkungsprothese, insbesondere zur verstärkung der bauchdecke

Info

Publication number
EP2983613A1
EP2983613A1 EP14716851.2A EP14716851A EP2983613A1 EP 2983613 A1 EP2983613 A1 EP 2983613A1 EP 14716851 A EP14716851 A EP 14716851A EP 2983613 A1 EP2983613 A1 EP 2983613A1
Authority
EP
European Patent Office
Prior art keywords
strips
prosthesis
segment
wall
anchoring
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.)
Withdrawn
Application number
EP14716851.2A
Other languages
English (en)
French (fr)
Inventor
Jean-Pierre COSSA
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.)
BiomUp France SAS
Original Assignee
BiomUp France SAS
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 BiomUp France SAS filed Critical BiomUp France SAS
Publication of EP2983613A1 publication Critical patent/EP2983613A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0068Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special 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
    • A61F2250/0023Special 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 porosity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special 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
    • A61F2250/003Special 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
    • A61F2250/0031Special 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

Definitions

  • Implantable prosthesis of reinforcement in particular for the reinforcement of the abdominal wall.
  • the present invention relates to the general field of implantable reinforcement prostheses intended to be implanted within the body of a human being or an animal.
  • Such prostheses are intended to reinforce a cell wall (or a biological tissue) in which have constituted, for whatever reason, complete or partial gaps that weaken said wall.
  • the anterior abdominal wall is composed of so-called large muscles organized in different axes and layers to ensure optimal elasticity to the abdominal strap. Breccias, which are called hernias, are likely to appear in this wall, either spontaneously or after surgery, imposing an operative repair.
  • a prosthetic reinforcement net to seal the altered wall and ensure a durable result, which requires a hold in place of the prosthesis relative to the wall for a time sufficient to ensure healing .
  • a net is similar to a piece of synthetic fabric, affixed as a patch on the weakened area, on the inner side of the abdominal wall, and whose meshes are intended to be gradually colonized by a healing tissue that integrates them into muscular architecture.
  • the shape of this net is generally rectangular or oval, adapted in size to the importance of the parietal defect to repair, so as to cover it with a sufficient peripheral support surface.
  • a kind of physiological glue is created which engulfs the prosthesis on its site and guarantees a definitive parietal reinforcement.
  • FR2914178 also discloses an implantable reinforcement prosthesis comprising a woven or non-woven textile reinforcement piece and anchoring threads connected to said reinforcing piece and intended to pass through the biological tissue surrounding the zone to be reinforced.
  • the anchoring son being provided with anchoring protrusions shaped to pass relatively freely through the tissue in one direction and then come to anchor in the tissue on the periphery of the zone covered by the reinforcing piece, to form a non-return means of said wire and thus firmly hold the prosthesis in place.
  • the son shown in this document are similar to the son called son anchors or barbed wire, otherwise known for example by EP2092895.
  • US2011130774 and US20090228021 also show prostheses comprising a reinforcing piece provided at its periphery with anchor wires intended to be inserted into the wall surrounding the area to be repaired covered by said part.
  • the son anchors are naturally flexible but have a certain rigidity due to their transverse dimension and the mechanical properties of the material that constitutes them, typically plastics such as polypropylene or polyglactin, which finally gives them a certain elasticity, but which exercises in an uncontrolled manner. In other words, at rest, these threads tend to be disordered, forming curves and loops as is moreover, well illustrated in the drawings of the aforementioned documents FR2914178 and US20090228021.
  • anchoring son can cause problems during the implementation of such a prosthesis, especially when it is envisaged to place the prostheses under laparoscopy.
  • the implementation of the prostheses for the repair of hernias under laparoscopy is carried out with the use of a camera positioned on a kind of periscope of 1 cm of diameter, connected to a video screen and allowing the surgeon to see the whole of the operative area without resorting to a large incision.
  • the prosthesis is rolled on itself like a cigarette sheet to be introduced by the periscope tube into a chamber created under the abdominal wall to be repaired by insufflation of gas. When the prosthesis is fully inserted into this chamber, it is unwound and placed on the area to be repaired.
  • the son anchoring means must not interfere with the introduction of the prosthesis into the abdomen.
  • the son are placed folded against the repair part before winding it on itself. Inside the cavity generated in the abdomen, the prosthesis unfolds. But, because of their anchors, the son can remain hooked on the fabric of the repair part, or conversely unfold anarchically, with the risk of clinging in unwanted places, to the wall of the cavity or on the intestinal loops, or to make between them knots.
  • these son arranged in a disordered manner may interfere with the proper installation of the repair part.
  • the present invention aims to solve the problems mentioned above, and aims in particular to allow the repair of hernias, including but not exclusively laparoscopically, more simply and efficiently.
  • the subject of the invention is an implantable prosthesis for reinforcing a biological wall of the human body, in particular of the abdominal wall, comprising a reinforcement piece, typically in the form of a textile net, woven or nonwoven, intended to be integrated with the inner surface of the wall to reinforce said wall.
  • the prosthesis is characterized in that it comprises a plurality of strips, called mooring strips, flat textile fabric extending from the edges of the reinforcing piece. These strips are intended to be placed in penetrating penetration into the wall on either side of the zone to be reinforced.
  • the mooring strips are intended to be placed, like the attachment son of the prostheses according to the prior art described above, in penetrating penetration into the muscle wall on either side of the area to be repaired or reinforced.
  • the strips thus immediately strap the prosthesis on its site by means of peripheral transfixing penetrations into the muscular wall.
  • the natural fibrosis of colonization of the trans- parietal strips, all the more developed as the strips have a width and therefore a relatively large area for said colonization to develop, allows very quickly to obtain an anchorage sufficiently strong to resist the efforts of everyday life, thus allowing optimal integration of the stabilized and secure prosthetic mesh around the area of the parietal defect to be reinforced.
  • this net is definitively stabilized, it forms then a kind of physiological glue which engulfs the prosthesis on its site of insertion.
  • one of the main problems is to ensure the most reliable stability possible, both in the first hours of implementation and in the longer term. Indeed, with the maturation of the peri-prosthetic fibrosis process that is generated and sought after as a repair principle, we can nonetheless observe secondary phenomena of contraction of the net under the retractile effect of the scar tissue, just as a skin scar can with the years, gradually collapse or even fade. The prosthetic cover surface can then considerably decrease, which can then lead to late recurrence of the hernia.
  • the anchoring son of the prior art certainly make it possible to ensure the immediate maintenance of the prosthesis when it is put in place, but they do not make it possible to effectively ensure this maintenance over time, and therefore do not allow to guard against the effects of these subsequent contractions of the prosthetic mesh.
  • the strips of the prosthesis according to the invention allow, by the natural fibrosis of colonization which takes place on these strips in their crossing of the abdominal wall, to ensure a better maintenance of tension of the prosthesis than by the son of attachment or known son anchors. It should be noted incidentally that this maintenance will be improved by ensuring that the trans-parietal passage of the strips is made obliquely, which ensures a greater contact area between the strips and tissue of the abdominal wall if the crossing is made perpendicular to the wall. Another advantage of these strips is that, not being filiform but flat, they have a better overall rigidity than the son, which facilitates the grip in the abdominal cavity to cross the wall.
  • the free end of the strips is profiled to facilitate its insertion through the incision formed in the wall.
  • the strips are supplemented by anchoring threads 30 interwoven into said strips, and extending along the length of said strips.
  • anchor son can also have an antibacterial function.
  • said son can be snuck into the fabric constituting the strips, after making this fabric and optionally cutting strips, which simplifies the making of the fabric but requires a subsequent operation of placing the son by basting.
  • Said yarns can also be directly woven during the making of said fabric constituting the strips.
  • antibacterial son for example of Vicryl ® PLUS allows to provide additional anti ⁇ infectious prophylaxis in response to the risk of contamination by exogenous prosthetic percutaneous route.
  • the anchoring threads also called self-locking or barbed threads, for example of the V-Lock® type or the like, comprise, for example, projections in the form of pins oriented obliquely with respect to the longitudinal direction of the thread and making it possible to complete and improve the initial maintenance of the prosthesis by the immediate anchoring they provide in biological tissues, including muscle, during the crossing of the abdominal wall.
  • An important advantage of the invention is that, after the prosthesis is inserted into the abdominal cavity but before the strips are inserted into the abdominal wall, the flat shape and the structure, in particular woven, of the strips ensures a stiffening of the threads.
  • the strips are formed in one piece with the reinforcement piece, for example by simultaneous cutting with the cutting of the reinforcement piece in a sheet of the material constituting said reinforcing piece.
  • This embodiment is particularly simple and limits the manufacturing costs of prostheses.
  • the placement of the anchoring threads in the strips may also be carried out simply by a kind of weaving of these threads in the longitudinal direction of the strips, in the woven material with a wide weft which constitutes the prosthesis and the said strips.
  • each strip comprises two different longitudinal segments, namely:
  • the two segments are each portions of strips.
  • the strip comprises only these two segments of strips, and does not include, for example, complementary thread for gripping the assembly.
  • Each strip may comprise one or more anchoring threads, and preferably comprises at least two, integrated for example near the edges of the strips.
  • each strip comprises three or four anchoring son extending in the direction of the strip and regularly distributed over the width of said strip.
  • the reinforcing piece and the strips are made essentially of polypropylene, polyurethane, and / or polyester.
  • the anchoring son are preferably made of resorbable monofilament.
  • the anchoring son preferably have a self-locking architecture, including including non-return members.
  • the prosthesis is typically made of a synthetic fabric based on polypropylene, polyurethane, and / or polyester, ideally with high porosity, that is to say with a sufficiently large mesh (pore diameter of
  • this net is preferably coated on one side, intended to be located towards the inside of the abdominal cavity, an anti movie ⁇ member, whose purpose is to achieve adhesion prevention intestines on the prosthesis.
  • a film anti adherent ⁇ may for example comprise at least one biological macromolecule absorbable and / or at least one synthetic polymer and / or natural such as collagen. It may for example be used a reinforcement piece similar to the product COVAMESH TM marketed by the company BIOM'UP.
  • this anti ⁇ adherent film will eventually be deleted strips, or may not be formed on them.
  • the free ends of the strips are held together by a holding wire or by a point of absorbable glue, and the prosthesis is wound on itself with the strips to the inside the winding.
  • the strips and the anchoring threads are well maintained inside the wound prosthesis and are not likely to catch in the trocar or tissues used. nearby.
  • the strips are released and can extend again in the plane of the reinforcing piece, while maintaining the anchoring son allowing easier seizure of the strips and son for the insert into the incisions provided for this purpose in the abdominal wall.
  • the free end of each strip comprises a visual marking, that is to say a marking allowing the surgeon to differentiate the free end of the strip from the rest of the strip, and to preferably the rest of the prosthesis.
  • This marking facilitates the placement of the prosthesis since it allows the surgeon - who exercises in a confined environment - to quickly grasp the end of the strip to deploy it and insert it through the parietal incision.
  • the reinforcement piece may have a rectangular shape (in particular square), the strips then extending respectively from the corners of the reinforcing piece, or an oval shape (in particular circular) and the strips then extend respectively according to the long axis and the minor axis of the oval.
  • Other forms of the reinforcement piece may also be used, and the number and arrangement of strips adapted accordingly, keeping the objective of ensuring the best possible maintenance of the prosthesis and the best possible immobilization thereof against the peritoneum, in adequacy with the seat of implantation and the required dimension.
  • Other features and advantages will become apparent in the description that will be made of a prosthesis according to the invention, and its implementation for the reinforcement of an abdominal wall with a hernia.
  • FIG. 1 is a sectional view illustrating the abdominal wall with a hernia
  • FIG. 2 is a plan view of a prosthesis according to the invention
  • FIG. 3 is a detailed view of a strip of the prosthesis
  • FIGS. 4 and 5 show the preparation of the prosthesis for its introduction into the abdominal cavity
  • FIG. 6 diagrammatically illustrates this introduction, while the prosthesis is wound on itself
  • FIG. 7 shows the separation of the strips and their expansion after the introduction of the prosthesis into the abdominal cavity
  • FIG. 8 illustrates, in plan view, the prosthesis in place centered on the zone to be repaired, before the strips pass through the abdominal wall, as well as the tools necessary for the operation,
  • FIG. 9 schematically illustrates in section the prosthesis in place against the peritoneum, and the ends of the strips protruding outside and ready to be cut,
  • FIG. 10 shows an alternative embodiment of the prosthesis
  • FIG. 11 is a detailed view of an alternative embodiment of a strip of the prosthesis.
  • Figure 12 illustrates the oblique insertion of a strip of Figure 11 through the wall of a patient.
  • FIG. 1 is a sectional view of the abdominal wall 1 with the hernia 2, in which the flat muscles 3 and the peritoneum 4 are seen, against which the prosthesis must be fixed in order to repair the tear of the hernia and to strengthen the entire the wall until complete healing and reconstitution of the wall in its normal state.
  • the proposed prosthesis shown in Figure 2 comprises a reinforcing piece 10, for example having a generally rectangular shape, and intended to provide this repair by application against the peritoneum and progressive integration into tissue, and several strips, for example four strips 20 extending respectively from the tops of the reinforcing piece 10.
  • the strips 20 extend towards the outside of the reinforcing piece 10, in a same plane.
  • the strips preferably have a profiled end, with a profiled profile. tip for example, to facilitate insertion through the incision formed in the wall of the patient.
  • the dimensions of the reinforcing piece are determined according to the hernia to be repaired, and can typically be for example of the order of 15 cm X 10 cm or 20 cm X 15 cm or even larger.
  • the length of the strip is generally dependent on the dimensions of the prosthesis, while taking into account the minimum length necessary to cross the entire wall in an oblique direction. It is also preferable that the length be sufficient to allow the temporary securing in the folded position of the various strips between them, without the folded strips protruding from the reinforcing piece.
  • a reinforcing piece having a rectangular shape with a diagonal length D it will preferably provide strips with a length greater than or equal to half the diagonal D, and preferably less than the length D of the diagonal.
  • the strips have a length for example of 10 cm to 15 cm and a width of the order of 5 mm to 10 mm.
  • the strips are preferably made in one piece with the reinforcing piece, for example by cutting the shape shown in Figure 2 in a suitable sheet of fabric.
  • the strips may however also be independent elements, reported and fixed at the periphery of the reinforcing piece.
  • the strips may for example be secured to the reinforcing piece by overmoulding, welding, knotting, and / or bonding.
  • a portion of the strip will be intended to be covered by the reinforcing piece at the point of attachment, and can not be used as a transfixing portion.
  • the length of the strip will therefore be adapted to the desired useful length, the useful length corresponding to the length of the strip portion intended to pass through the wall.
  • the reinforcement piece preferably comprises two faces having different specific properties.
  • the prosthesis used is called bifaces, that is to say that it has two different faces:
  • the characteristic sought for the outer face 11 is the most effective adhesiveness and fast possible, so as to ensure the fastest and reliable anchoring of the prosthesis at the chosen site.
  • a piece of synthetic fabric based on polypropylene, polyurethane, and / or polyester, in the form of a woven or knitted net with, for example, a weft or mesh of the order of 1 mm to a few millimeters, will be used. .
  • the inner face 12 is in turn made to be the least adhesiogenic possible, because it is intended to be facing the inside of the abdominal cavity and facing its content, that is to say the handles intestinal which are mobile and likely to be in contact with the prosthesis, especially after sagging distention of the abdominal cavity, by suppressing the insufflation of pneumoperitoneum at the end of the intervention, as will be described later .
  • the inner face 12 of the prosthesis is for example formed by a non-stick film covering one side of the piece of cloth, and whose purpose is to obtain a prevention of intestinal adhesions on the most effective prosthesis possible.
  • This release film typically consists of a cover layer fixed to the piece of fabric constituting the outer face, in a known manner.
  • the release film may for example be based on collagen.
  • the reinforcing piece having a textile piece incorporating a collagen layer can be designed according to the teachings of the international application WO2010125086 or the international application WO2011079976.
  • the strips 20 may comprise anchoring threads 30, typically of the V-Lock ® type, inserted along the strips, and preferably arranged on their edges.
  • anchoring threads 30 are, for example, positioned by weaving in the stitches of the weft forming the strips 20.
  • the anchoring pins of these anchoring threads 30 are oriented in the direction, indicated by the arrow F, allowing sliding in the biological tissues subsequently traversed by the strip carrying said threads, and ensuring anchoring in said tissues in the other senses. These anchoring pins thus act as non-return organs vis-à-vis the biological tissues crossed.
  • the anchoring threads 30 are thus held by the strip where they are inserted as long as they are not inserted into the abdominal wall, and subsequently ensure their anchoring effect in the biological tissues on each side of said tongue since said son and their pins are apparent alternately on one and the other of said faces.
  • the prosthesis is conditioned so as to allow its introduction into the abdominal wall, for example by means of a trocar 41, as shown in FIG. 6.
  • the strips 20 are folded against the reinforcement piece of the side of its outer face 11 and connected together by a junction wire 21 for example, as shown in Figure 4.
  • the prosthesis is then wound on itself, as shown in FIG. 5, on its largest axis, with the strips inside the coil, to form a cylinder as shown in FIG. 6, of sufficiently small diameter to pass into the trocar 41.
  • the prosthesis In laparoscopic procedure, the prosthesis is placed in the chamber constituted by the abdominal cavity 5, previously stretched by gas insufflation (pneumoperitoneum).
  • gas insufflation pneumoperitoneum
  • the purpose of this insufflation is to have a sufficient work space, general anesthesia is also necessary to allow muscle relaxation and allow the distension of the abdominal strap.
  • trocars sealed valves
  • an optical tube 10 mm in diameter coupled to a high definition camera connected to a video screen, to ensure the exploration and visual control of the surgical procedure
  • the prosthesis having been conditioned as indicated previously in the form of a cylinder, this cylinder is introduced inside the inflated abdominal cavity, through a trocar 41 of 10 mm or 12 mm, as shown in FIG. that the ease of introduction of the prosthesis allows a minimization of its time of exposure to air and its digital manipulation.
  • the prosthesis tends to unfold itself, by elasticity, this sequence being possibly assisted and controlled by the instruments handled by the surgeon.
  • the latter then cuts the link 21 connecting the strips, allowing the deployment thereof.
  • This deployment benefits on the one hand from the volume formed in the abdominal cavity by its swelling, and on the other hand from the natural tendency, resulting from its constitution and the properties of its constituent material, from the prosthesis to recover a flat shape, for extend the strips, allowing their subsequent easy entry.
  • the surgeon assists this deployment and centers the prosthesis on the defect 2 to be repaired, as shown in Figure 8, bringing the reinforcing piece 10 against the inner face of the abdominal wall.
  • the strips 10 are successively gripped by mini-pliers and pulled outwards.
  • the incisions are preferably made obliquely in the abdominal wall, so as to have an oblique path of the strips 20 thus ensuring an increased contact area between each segment of trans-parietal strip and the various muscle layers of the abdominal wall traversed.
  • the superiority of rigidity of the strips 10 relative to the anchoring son of the prior art facilitates their handling which can be done using a single clamp.
  • the tensioning of the four strips 10 will allow optimal centering and plating of the prosthesis on the abdominal wall, and provide immediate stabilization of its seat which then allows stapling or gluing of intra-abdominal complementary fixation in excellent conditions of comfort and reliability.
  • prosthetic stapling is facilitated and, thanks to the tensioning of the prosthesis, obtained by the strips, it avoids in particular the risk of folding of the prosthesis at the time of prosthesis. stapling.
  • each strip in its parietal crossing tissue environment will progressively be trapped by a network of three-dimensional collagen fibers which will ensure their colonization by scar tissue. .
  • This secondary mooring will thus build a prosthetic fixation reinforcement to protect against the risk of secondary prosthetic dislocation or retraction of prosthetic cover surface by secondary contraction effect, resulting in both cases to late recurrence phenomena.
  • the positioning of the prosthesis is facilitated by the use of a laying pattern serving as a marker template for locating the incision points through which the strips are intended to be positioned.
  • Such a laying pattern may be provided with the strip prosthesis in a kit, the pattern may for example be drawn on the sterile package in which the prosthesis strips is packaged.
  • the marks determining the position of the incision points to be formed are taken before insufflation and thus distention of the abdominal cavity, in order to allow an optimal prosthetic centering taking into account the obliquity parameters of the trans-parietal path of the strips which makes it possible to optimize their contact surface and thus the anchoring capacity, especially in the trans-muscular layer. Furthermore, it will also be preferentially estimated the desired margins of surface covered by the prosthesis with respect to the specific characteristics of the parietal defect to be treated (size and direction of the main axis, suture of approaching or not of the fascial banks, quality of the tissue support, anchoring possibilities, parietal adiposity and desired over-lapping).
  • the laying pattern is provided so that the entry points of the incision on the skin of the patient are placed at a distance that makes it possible to form an obliquity angle at least equal to 45 °, and preferably a angle of obliquity of 60 °.
  • Skew angle is here referred to as the angle formed between a strip and the perpendicular to the plane tangent to the surface of the prosthetic tissue at the point of attachment of the strip, as illustrated in Figure 12.
  • the laying pattern may be formed of a main piece having the same shape and the same dimensions as the prosthesis reinforcement piece, where ear-shaped elements are arranged in a manner similar to the strips, these ears comprising markers to mark the incision points to be formed. It can be envisaged that each ear comprises several markers depending on the angle of obliquity chosen and / or depending on the thickness of the wall to be crossed for the strips to emerge outside the patient.
  • the strips 120 associated with the reinforcing piece 10 comprise two different longitudinal segments, namely:
  • the anchoring segment 121 of the strip comprises an end secured to the reinforcing piece, while its opposite end is secured to one end of the gripping segment 122.
  • the second end of the gripping segment corresponds to the free end of the the strip intended to be outside the patient once the prosthesis is in place.
  • the strips 120 In order for the strips 120 to be able to be tensioned, it is necessary that they cross the entire wall and emerge outside the patient.
  • the anchoring channel useful through the wall is that of the dense and tonic muscle layer in which the strip can anchor, by phishing, for example, and where cell colonization intervenes to strengthen the adhesion.
  • the primary anchorage of the strip is less efficient, the subsequent cell colonization of the textile forming the strip being also less reliable in this region.
  • the presence of a strip portion in this superficial region, particularly greasy can generate discomfort for the patient, with a risk of septic contamination of cutaneous origin.
  • a strip having two distinct segments having two distinct segments, the first segment being specially sized to promote useful anchoring in the muscular region of the wall, while the second segment is dimensioned to minimize its negative impact vis-à-vis -vis the patient, while allowing a tensioning of the strip from the outside of the patient.
  • each of the two longitudinal segments forming the strip are themselves portions of strips, in particular having a certain width, and having the advantages described above, especially in terms of handling, with respect to son for example.
  • the anchoring segment 121 may comprise specific anchoring means, in the form of anchoring threads 130 for example, which may be similar to those described above. . These anchor wires contribute to strengthening the rigidity of the anchor segment.
  • Yarns may also be provided in the gripping segment 122 to stiffen the corresponding strip segment.
  • this wire has no specific anchoring means, unlike the anchoring segment.
  • these son have an antibacterial function to reduce the risk of spread of possible infections.
  • the two segments of the strip are traversed by a single thread, in which case a complex yarn having a portion with anchoring elements for the anchoring segment and a portion devoid of anchoring elements for the gripping segment.
  • the anchor segment has a width at least two times greater than the width of the grip segment.
  • the anchoring segment may for example have a fixed width of between 5 mm and 10 mm, while the gripping segment will have a smaller width, of the order of 2 mm to 3 mm. As a result, the impact of the grasping segment on the patient is reduced.
  • the total length of the strip is substantially the same for a multi-segment arrangement as for a single-segment arrangement as described above.
  • the length of the gripping segment is however at least equal to the length of the anchor segment. According to a preferred embodiment, the gripping segment is at least two times longer than the anchoring segment, and preferably at least three times longer.
  • an anchor segment having a length of 20 mm to 30 mm, while the gripping segment has a length of 60 mm to 90 mm.
  • anchoring means can also be planned to form the segment anchoring with a material and according to a weaving / knitting different from those of the gripping segment.
  • the mesh of the anchoring segment be of large pores, having a diameter of one millimeter to a few millimeters, preferably of 3 mm to 6 mm, to promote cell colonization while allowing to preserve some porosity (for example 60%) after integration of the strips.
  • the wire used is non-absorbable, preferably multi-filaments.
  • the mesh of the fabric forming the gripping segment may be identical to that forming the anchoring segment. It is also possible to envisage a gripping segment having a mesh that is tighter than the mesh of the gripping segment, that is to say with pores of smaller diameter, which makes it possible to reinforce the rigidity of this portion of the strip, without use other specific means.
  • the wire used to form the grasping segment may be non-absorbable but is preferably resorbable, so as to remove any discomfort for the patient after integration.
  • the yarn used is preferably monofilament, to reduce the risk of chronic inflammation by bacterial colonization.
  • the gripping segment is generally designed to minimize the foreign body surface implanted in these cutaneous and subcutaneous layers, while maintaining a minimum rigidity of the strip to ensure easy handling.
  • the embodiment shown in Figure 11 shows a strip which is independent of the reinforcing member, and secured thereto at an attachment point 123 at the corner of the reinforcing piece.
  • the strips have a certain axial elasticity, that is to say an ability to lengthen according to the length of the strip and to resume its initial length without deformation.
  • Such axial elasticity makes it possible to guarantee a cushioning role for the portions of the strips in the trans-muscular zone, thus conferring on them a function of "tensioners" of the reinforcing piece, but also to allow a certain spontaneous retraction of the segments in the zone. trans-fat after stretching of the externalized part to make it easier to bury after cutting close to the skin.
  • strips having an axial elasticity of 20% to 30% may be used.
  • the transverse elasticity of the strips can be of the order of 15%.
  • the prosthesis strips intended for the reinforcement of the abdominal wall are preferably designed to respond to physiological variations in intraperitoneal pressure (maximum threshold measured according to the Laplace model at 252 cm of water) requiring the maintenance of elasticity of the abdominal wall segment repaired by prosthetic equipment, with recommended thresholds of 25% for the cranio-caudal axis and 15% for the transverse axis.
  • the reinforcing piece is preferably biface, one side being formed by a textile mesh and the other side being a layer having non-stick properties.
  • the strips are in turn not covered with such a nonstick layer since it is instead sought a good anchoring, especially in the muscular area.
  • the shape of the reinforcement piece may be different from a rectangle, for example an oval shape as shown in FIG. 10, in which case the strips preferably extend along the axes of this oval, or any other form adapted to needs.
  • a specific rectangular shape of the prosthesis may be a square, while a specific oval shape of the prosthesis may be a circle.
  • the number of strips can also be modified, and the integration of self-locking or antibacterial son in them can be achieved from the manufacture of strips by weaving.
  • the application of the prosthesis is not limited to use under laparoscopy.
  • the prosthesis is preferably intended for the repair of the abdominal wall, but can also be used, in various dimensions, so as to be able to use the same principle of restraint to any loss of bodily substance, when a direct repair by conventional pathways, such as direct suture for example, can not be performed but it is however necessary to provide temporary or permanent restraint (eg enlargement plasty, etc.) or to plan the reconstruction of a loss. of organic substance.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)
EP14716851.2A 2013-04-11 2014-04-11 Implantierbare verstärkungsprothese, insbesondere zur verstärkung der bauchdecke Withdrawn EP2983613A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1353277A FR3004333B1 (fr) 2013-04-11 2013-04-11 Prothese implantable de renfort, en particulier pour le renfort de la paroi abdominale
PCT/EP2014/057452 WO2014167131A1 (fr) 2013-04-11 2014-04-11 Prothese implantable de renfort, en particulier pour le renfort de la paroi abdominale

Publications (1)

Publication Number Publication Date
EP2983613A1 true EP2983613A1 (de) 2016-02-17

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EP14716851.2A Withdrawn EP2983613A1 (de) 2013-04-11 2014-04-11 Implantierbare verstärkungsprothese, insbesondere zur verstärkung der bauchdecke

Country Status (9)

Country Link
US (1) US20160030148A1 (de)
EP (1) EP2983613A1 (de)
JP (1) JP2016514609A (de)
CN (1) CN105228555B (de)
AU (1) AU2014253045B2 (de)
BR (1) BR112015025485A2 (de)
CA (1) CA2909246A1 (de)
FR (1) FR3004333B1 (de)
WO (1) WO2014167131A1 (de)

Families Citing this family (6)

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EP3188689B1 (de) * 2014-09-04 2023-07-05 Duke University Implantierbares netz
FR3039057B1 (fr) * 2015-07-20 2017-08-11 Edouard Pelissier Protheses de reparation de hernies
US11484401B2 (en) 2016-02-01 2022-11-01 Medos International Sarl Tissue augmentation scaffolds for use in soft tissue fixation repair
US11357495B2 (en) 2016-02-01 2022-06-14 Medos International Sarl Tissue augmentation scaffolds for use with soft tissue fixation repair systems and methods
CN105997297B (zh) * 2016-06-30 2017-08-11 凌安东 治疗子宫脱垂用的医用材料
IT201800007499A1 (it) * 2018-07-25 2020-01-25 Angiologica Bm Srl Protesi parietale di supporto, in particolare per prolassi pelvici

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US7285086B2 (en) * 2004-07-28 2007-10-23 Ethicon, Inc. Minimally invasive medical implant and insertion device and method for using the same
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EP2395941B1 (de) * 2009-02-11 2017-01-11 Nanyang Technological University Mehrschichtige chirurgische prothese
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WO2012123582A1 (en) * 2011-03-16 2012-09-20 Sofradim Production Prosthesis comprising a three-dimensional and openworked knit

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Also Published As

Publication number Publication date
BR112015025485A2 (pt) 2017-07-18
FR3004333B1 (fr) 2019-08-23
AU2014253045B2 (en) 2018-12-13
CN105228555A (zh) 2016-01-06
JP2016514609A (ja) 2016-05-23
FR3004333A1 (fr) 2014-10-17
WO2014167131A1 (fr) 2014-10-16
CN105228555B (zh) 2017-08-25
CA2909246A1 (fr) 2014-10-16
AU2014253045A1 (en) 2015-10-22
US20160030148A1 (en) 2016-02-04

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