Patent Application
20170065392
The present invention relates to a method for producing a prosthesis for reinforcing an abdominal wall in which an incision has been made, said prosthesis being formed from a T-shaped knitted structure made in one piece.
The abdominal wall in humans is composed of fat and muscles interconnected by fascias. It sometimes happens that a break in continuity occurs in the fascias, allowing part of the peritoneum to slip through and form a sac, or a hernia, containing either fat or part of the intestines. A hernia of this kind can occur on a parietal scar following surgery and is then called an incisional hernia. An incisional hernia shows itself in the form of a bulge at the surface of the skin, and its reduction necessitates a further surgical intervention.
Following a surgical intervention that required an incision of the abdominal wall, for example in vascular or gynaecological surgery, it is therefore important that the closure of the incision made in the abdominal wall is optimal, so as to reduce the risks of future occurrence of an incisional hernia. With this in mind, it is desirable to be able to reinforce the abdominal wall, and in particular the muscles thereof, at the site where the suture has been made to close the incision.
In the field of prevention or repair of hernias in general, prostheses exist which comprise, for example, a first sheet of material intended to plug the hernial defect, and a second sheet of material intended to be placed in contact with the viscera, the first and second sheets being substantially perpendicular to each other, such that a transverse cross section of the prosthesis generally forms a T shape, one sheet forming the vertical bar of the T, the other sheet forming the horizontal bar of the T.
These sheets of material can be openworked. In the present application, “openworked material” is understood as meaning that the material has openings or pores at its surface and within its body. An openworked material promotes cell recolonization once the prosthesis has been implanted.
The existing T-shaped prostheses are generally produced from two separate sheets, which are subsequently joined to each other to obtain said T shape. Thus, the method of producing these existing prostheses is long-winded and complicated. The two sheets of material can be joined, for example, by sewing or else by a thermal welding means. However, particularly when these sheets are made of openworked material, such joining means may create a weakness of the prosthesis, for example a point of weakness at the join between the two sheets of material. Once implanted, the prosthesis is subjected to various pressures and/or tensions, for example by the abdominal cavity or by the muscles of the abdominal wall, which pressures and/or tensions are generated by the movements and/or efforts made by the patient in his or her daily routine. This point of weakness could therefore prove dangerous for the patient in the event of tearing.
Moreover, every solution for joining the first sheet of material to the second sheet of material in the existing prostheses, by adding a foreign material to the prosthesis or by modifying the chemical structure of the prosthesis by a thermal or mechanical process, is susceptible of creating a discontinuity in the performance of the prosthesis as a whole, and such discontinuity is undesirable.
There is still therefore a need for a reinforcement prosthesis that would comprise a skeleton of which the transverse cross section would generally form a T, hereinafter referred to for simplicity as a “T-shaped” skeleton, structure or prosthesis, having no area of weakness at the join between the vertical bar and the horizontal bar of the T.
There is also still a need for a method allowing simple and rapid production of such a T-shaped skeleton made of openworked material from which it would be possible to produce such a reinforcement prosthesis, having a continuous strength throughout the prosthesis, without any area of weakness at the join between the vertical bar and the horizontal bar of the T.
The present invention aims to meet this need by making available a prosthesis for reinforcing an abdominal wall in which an incision has been made, said prosthesis comprising a knitted structure made in one piece, said knitted structure comprising a first portion, which is substantially plane and flexible and is intended to be placed between the abdominal wall and the abdominal cavity, and a second portion, which is substantially plane and flexible and is intended to be placed between the two margins of the incision, said second portion extending substantially perpendicularly from one face of said first portion.
The present invention also relates to a method for producing such a prosthesis, said method comprising the following steps:
a) producing a knit comprising a base sheet which is substantially plane and elongate and which is equipped in its longitudinal direction with a succession of folds substantially perpendicular to said sheet, by knitting biocompatible yarns on a warp knitting machine, said yarns being distributed on at least three guide bars B1, B2 and B3, said three bars operating according to a defined weave repeat recurring as desired along the production length of the knit, each bar being supplied with a yarn coming from a corresponding warp beam rod at a dedicated run-in appropriate to the movement of said bar in accordance with said weave repeat, at least bar B1 having a variable dedicated run-in D1, the value of said variable dedicated run-in D1 decreasing and tending towards 0 on a part of said weave repeat, the decrease in the value of said run-in D1 on said part of said weave repeat generating a said perpendicular fold,
b) cutting from the knit obtained in step a) a knitted structure comprising a part of said base sheet equipped with a perpendicular fold, said part of the base sheet forming said first portion of the prosthesis, and said perpendicular fold forming said second portion of the prosthesis.
The knitted structure forming the T-shaped skeleton of the prosthesis according to the invention is made in one piece, in particular in one knit, obtained in a single knitting step. In the present application, a knitted structure made in one piece is understood as meaning that said structure is produced in a single knitting step and is not formed from two or more separate pieces that are connected by a joining means, for example sewing, ultrasonic welding, etc. Thus, in the knitted structure of the prosthesis according to the invention, the yarns from which it is made present a continuity across the entire surface of the structure.
In particular, the T-shaped skeleton of the prosthesis according to the invention is not obtained by joining two sheets of material. In the prosthesis according to the invention, the first portion, which is intended to be placed between the abdominal wall and the abdominal cavity, and the second portion, which is intended to be placed between the two margins of the incision, are one and the same knit. As a result, the join between the two portions does not require any connecting means, for example sewing, thermal welding, etc. Indeed, as will become clear from the description below, it is the same yarns that form both the base sheet of the knit, in other words the first portion of the prosthesis, and also the perpendicular folds of the knit, in other words the second portion of the prosthesis.
In the present application, “plane and flexible portion” is understood as meaning that said portion has the general form of a plane textile and that it can be manipulated and deformed easily, for example in order to fold it back on itself at the time of introduction of the prosthesis into the body of a patient. Moreover, the knitted structure is formed from biocompatible yarns that have a rigidity necessary for maintaining the T shape of said knitted structure, that is to say for maintaining the perpendicular position of the second portion with respect to the first portion, in the absence of any stress exerted on a portion of said structure.
The production method according to the invention makes it possible to produce a knitted structure of which the transverse cross section has the overall shape of a T, without creating discontinuity between the first portion (horizontal bar of the T) and the second portion (vertical bar of the T) of said knitted structure.
Indeed, according to the method of the invention, a knit is produced which comprises a substantially plane base sheet provided with a succession of folds that are substantially perpendicular to said base sheet.
A warp knitting machine can comprise one or more guide bars. Each guide bar is supplied with a particular yarn that is stored in wound-up form on what is called a warp beam rod, said yarn being unwound from the warp beam rod at the rate by which it is used up in the movements of said guide bar when the latter performs its part in producing the knit according to the defined weave. In the field of knitting, the weave defines the movements of the yarns of the guide bars for forming the desired meshes in the course of production of the knit. The expression “weave repeat” applies to the basic pattern of these movements and corresponds to a defined number of meshes, the knit being produced by means of the weave repeat recurring as desired.
Corresponding to each guide bar, there is a particular yarn and a particular warp beam rod. For each combination of “guide bar/corresponding warp beam rod”, the yarn is unwound from the warp beam rod at a dedicated run-in for said guide bar. Thus, each guide bar is supplied with a particular yarn at a dedicated run-in, independently of the yarns and the run-in rates of the other guide bars. The different run-in rates can be regulated by motors which can be managed by mechanical or electronic systems.
Since the production of the knit causes yarns to be used up, the respective values of the respective dedicated run-in rates of the different guide bars cannot be values less than zero and are generally positive.
By way of example, the values of the dedicated run-in rates of the guide bars in general in a warp knitting machine are generally above 1,000 mm/rack, a rack corresponding to 480 meshes.
In the present application, a “positive” value of a dedicated run-in is understood as a value of greater than or equal to 1,000 mm/rack, a rack corresponding to 480 meshes. In the present application, a value “tending towards 0” of a dedicated run-in is understood as meaning that the value of said run-in is less than or equal to 50 mm/rack, preferably less than or equal to 25 mm/rack, a rack corresponding to 480 meshes.
According to the method of the invention, the temporary decrease (temporary since only on part of the weave repeat) in the value of the variable dedicated run-in of bar B1, in such a way as to cause this value to tend towards 0, makes it possible to slow down the production of that part of the knit generated by the movement of bar B1, and a fold, said perpendicular fold, forms. However, during the time of this slowing down, all of the yarns threaded on the three bars continue to cooperate with each other to form said weave repeat, and no discontinuity forms between the fold thus generated and the base sheet of the knit.
The regulation of the run-in D1 and the variation of its value can be generated by an electronic system controlling the guide bar B1.
Thus, the prosthesis according to the invention, comprising a T-shaped knitted structure obtained from such a knit, no longer has any discontinuity in its mechanical performance between the two portions of its knitted structure, namely between the horizontal bar and the vertical bar of the T. No point or line of weakness is created in the knitted structure of the prosthesis according to the invention.
The prosthesis according to the invention thus has good strength when it is stressed in a direction perpendicular to the joining line between the two portions of its knitted structure. In the prosthesis according to the invention, the risk of tearing at the join between the two portions of the knitted structure of the prosthesis is extremely limited.
In one embodiment of the method according to the invention, each of bars B2 and B3 has a dedicated run-in (D2, D3) that is constant over the whole of said weave repeat. As has been seen above, the values of the dedicated run-in rates D2 and D3 are positive. These values can, for example, be greater than or equal to 1,000 mm/rack. For example, these values vary from 1,000 to 2,500 mm/rack, a rack corresponding to 480 meshes. The value of D2 can be different than the value of D3. Alternatively, D2 and D3 can have the same value.
Thus, during a defined period of the weave repeat, in other words during a defined number of meshes, the three bars B1, B2 and B3 are supplied with yarns according to respective positive dedicated run-in values, all of them preferably greater than or equal to 1,000 mm/rack, for example ranging from 1,000 to 2,500 mm/rack, and they form the substantially plane base sheet of the knit. Sequentially, since recurring at each new resumption of the weave repeat, the value of the dedicated run-in of bar 1 is decreased so as to tend towards 0 over part of the weave repeat, that is to say during a defined period of time corresponding to a defined number of meshes. During this defined period of time, the values of the respective dedicated run-in rates of the two other bars B2 and B3 are not decreased and they are kept constant. Thus, bars B2 and B3 continue to produce their respective parts of the knit of the base sheet. Since the latter cannot be generated in the direction of production of the knit on account of the value of the run-in D1 of bar B1 tending towards 0, it extends perpendicularly with respect to the direction of production of the knit and forms a fold. When the dedicated run-in D1 recovers its initial positive value of greater than or equal to 1,000 mm/rack, the three bars resume their respective productions of the knit in the direction of production of the knit and they again form the substantially plane base sheet.
In one embodiment of the method of the invention:
Thus, in such a case, for each bar, the weave repeat comprises 138 meshes. The value of the run-in D1 of bar B1 is forced to tend towards 0 during 45 meshes (part of the weave repeat [(0-0)×45]). The perpendicular fold of the knit therefore forms during these 45 meshes, and it is formed from the yarns of bars B2 and B3 which continue to produce their respective weave repeats, determined by their respective charts shown above, during these 45 meshes.
Since the weave repeat recurs in the direction of production of the knit as the knitting machine is fed, a knit comprising a base sheet and a succession of substantially perpendicular folds is produced. Moreover, since the same weave repeat recurs every 138 meshes along the length of production of the knit, the perpendicular folds are spaced apart from one another at regular intervals.
The values given above for the charts, threadings and weave repeats have of course been given as examples. Other charts, threadings and weave repeats can be used to produce a knit comprising a base sheet provided with a succession of substantially perpendicular folds, if the value of the dedicated run-in D1 is forced to tend towards 0 on part of the weave repeat of bar B1.
To produce the prosthesis according to the invention, it then suffices to cut the resulting knit on each side of a substantially perpendicular fold in order to obtain a knitted structure made in one piece and having a T-shaped transverse cross section free of any discontinuity or weakness at the join between the vertical and horizontal bars of the T. Indeed, as will become clear from the description below, the yarns of bar B1, which join the perpendicular fold to the base sheet, are an integral part of the knit, and they are thus likewise an integral part of the knitted structure obtained by cutting as described above, by joining the vertical bar of the T to the horizontal bar of the latter.
The knitted structure of the prosthesis according to the invention is openworked. It has openings or pores at its surface and within its body, corresponding in particular to the different meshes of said knit. Such an openworked structure promotes the penetration of cells into the knitted structure and, therefore, the cell recolonization of the prosthesis after implantation.
The knitted structure can be used as it is to form a prosthesis for reinforcing the abdominal wall, or it can form part of such a reinforcement prosthesis. In particular, the knitted structure can be subjected to one or more steps that are customary in the manufacture of a prosthesis, for example thermosetting, washing, cutting, thermoforming.
In one embodiment, the knitted structure can be partially or completely coated on some or all of its faces with a coating of biocompatible material, for example anti-adhesion material. Alternatively or in addition, the knitted structure can be combined with another textile to form a composite reinforcement prosthesis.
The knitted structure is sufficiently flexible to be folded back on itself if necessary, for example at the time when introducing it into the abdominal cavity.
The knitted structure of the prosthesis according to the invention can be bioabsorbable, permanent, or partially bioabsorbable. Thus, it can be produced by knitting biocompatible yarns, for example monofilaments and/or multifilaments, made of any bioabsorbable or non-bioabsorbable biocompatible material.
In one embodiment, the knitted structure is composed of monofilament yarns. With such an embodiment, it is possible in particular to obtain a good stability of the knitted structure, in particular a good retention of its T shape, in the absence of any external stress exerted on said structure.
The monofilament yarns can have any diameter with which it is possible to obtain a knit that is suitable for the production of a prosthesis for reinforcing the abdominal wall. For example, the mean diameter of the monofilament yarns can vary from 80 μm to 200 μm.
In one embodiment of the method of the invention using bars B1, B2 and B3 and the threadings and weave repeats described above, and with said three bars B1-B3 being threaded with monofilament yarns made of one and the same biocompatible material, the monofilament yarn threaded on bar B1 has a mean diameter greater than the respective mean diameters of the monofilament yarns threaded on bars B2 and B3. Such an embodiment permits optimal continuity of the properties of strength of the two portions of the knitted structure thus obtained in the area of the joining line of said two portions. Therefore, the risks of the prosthesis, obtained from such a knitted structure, tearing after implantation, and when subjected to the pressures and forces resulting from the everyday movement of the patient, are extremely limited.
In the present application, “bioabsorbable” is understood as the characteristic by which a material is absorbed by the biological tissues and disappears in vivo after a given period which, for example, can vary from one day to several months, depending on the chemical nature of the material.
The knitted structure of the prosthesis according to the invention can be produced from yarns that are entirely bioabsorbable, in particular if it is intended to disappear after having performed its reinforcing function while cell colonization takes place and tissue rehabilitation takes over. Thus, in one embodiment, said knitted structure is composed of bioabsorbable yarns.
In other embodiments, the knitted structure can comprise non-bioabsorbable yarns if the prosthesis is intended to act as a permanent reinforcement and to remain definitively within the body of the patient.
Thus, the bioabsorbable materials suitable for the yarns of the knitted structure of the present invention can be chosen from among polylactic acid (PLA), polyglycolic acid (PGA), oxidized cellulose, polycaprolactone (PCL), polydioxanone (PDC), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoates (PHAs), polyamides, polyesters, copolymers thereof, and mixtures thereof. The non-bioabsorbable materials suitable for the yarns of the knitted structure of the present invention can be chosen from among polyethylene terephthalate (PET), polyamides, aramids, expanded polytetrafluoroethylene, polyurethane, polyvinyl idene di fluoride (PVDF), polybutyl esters, PEEK (polyether ether ketone), polyolefins (such as polyethylene or polypropylene), copper alloys, silver alloys, platinum, medical grades of steel such as medical-grade stainless steel, and combinations thereof.
In one embodiment, the face of said first portion intended to be placed opposite the abdominal cavity is covered by an anti-adhesion coating.
In the present application, “anti-adhesion” is understood as referring to a biocompatible material or coating that is smooth and non-porous, provides no space for cell recolonization and prevents the surrounding organs from attaching themselves to the prosthesis.
The anti-adhesion material or coating can be chosen from bioabsorbable materials, non-bioabsorbable materials and mixtures thereof.
The non-bioabsorbable anti-adhesion material can be chosen from polytetrafluoroethylene, polysiloxanes, polyurethanes, stainless steels, derivatives of precious metals, and mixtures thereof.
Said anti-adhesion material or coating is preferably bioabsorbable: the bioabsorbable materials suitable for said anti-adhesion coating can be chosen from collagens, for example oxidized collagen, oxidized celluloses, polyacrylates, trimethylene carbonates, caprolactones, dioxanones, glycolic acid, lactic acid, glycolides, lactides, polysaccharides, for example chitosans, polyglucuronic acids, hyaluronic acids, dextrans, fucans, polyethylene glycol, glycerol and mixtures thereof.
Upon implantation of the prosthesis according to the invention, the anti-adhesion coating makes it possible, at least during the initial phase of healing, to protect the knitted structure of the prosthesis at the place where this anti-adhesion coating is present; thus, the covered face is not exposed to inflammatory cells such as granulocytes, monocytes, macrophages or even the multi-nuclear giant cells that are generally activated by the surgery. Indeed, at least during the initial phase of healing, the duration of which can vary between 5 and 10 days approximately, only the anti-adhesion coating can be accessed by the various factors such as proteins, enzymes, cytokines or cells of the inflammatory line.
In the case when the anti-adhesion coating is made of non-absorbable materials, it thus protects the knitted structure before and after implantation, throughout the period of implantation of the prosthesis.
Moreover, by virtue of the anti-adhesion coating, the surrounding fragile tissues, for example the hollow viscera, are protected, in particular from the formation of undesirable and serious post-surgical fibrous adhesions.
In the case when the anti-adhesion material comprises a bioabsorbable material, it is preferable to choose a bioabsorbable material that is absorbed only after a few days, so as to ensure that the anti-adhesion coating can perform its function of protecting the surrounding organs during the days after the operation and until the cell recolonization of the prosthesis in turn protects these organs.
In one embodiment, the anti-adhesion coating is in the form of a bioabsorbable film.
Examples of methods by which the knit is covered by an anti-adhesion coating are given in the applications WO9906079 and WO9906080.
The advantages of the present invention will become clearer from the following description and example and from the attached drawings, in which:
A knit comprising a base sheet and a succession of substantially perpendicular folds is produced by the method according to the invention on a warp knitting machine with three guide bars B1, B2 and B3, such as those described above, where bar B1 is in position 1 on the knitting machine, bar B2 is in position 2, and bar B3 is in position 3. The threading, the run-in rates, the weaves and the charts are the following, in accordance with the standard ISO 11676:
Bar B1 is threaded 1 full, 3 empty, its dedicated run-in D1 is variable: thus, the value of D1 is positive and constant, in other words ranging from 1,000 to 2,500 mm/rack, a rack corresponding to 480 meshes, on a first part of the weave repeat, namely on the part [(0-0/0-0/1-0/1-1/1-1/1-0)×15]. Then this value decreases and tends towards zero on the part of the weave repeat [(0-0)×45].
The yarn threaded on bar B1 is, for example, a monofilament yarn of polylactic acid (PLA) having a mean diameter of 150 μm.
Bar B2 is threaded 1 full, 1 empty, its dedicated run-in D2 has a positive constant value, in other words ranging from 1,000 to 2,500 mm/rack, a rack corresponding to 480 meshes.
Bar B3 is threaded 1 full, 1 empty, its dedicated run-in D3 has a positive constant value, in other words ranging from 1,000 to 2,500 mm/rack, a rack corresponding to 480 meshes.
The yarns threaded on the bars B2 and B3 are, for example, monofilament yarns of polylactic acid (PLA) having a mean diameter of 80 μm.
Thus, the present example will result in a knit, hence a knitted structure, that is entirely bioabsorbable.
Alternatively, if the aim is to produce a permanent knit, that is to say a non-bioabsorbable knit, the yarns threaded on the three bars could be monofilaments of polyethylene terephthalate (PET).
As will be clear from the above weave repeats, when the values of the three run-in rates D1, D2 and D3 are positive and constant, the chart comprises 6 meshes (numbered from 1 to 6 in
When they are constant and positive, the values of run-in rates D1-D3 are appropriate to the respective movements of the guide bars. By way of example, these values are generally in excess of 1,000 mm/rack, a rack corresponding to 480 meshes.
Moreover, the weave repeat comprises 138 meshes. Thus, for bars B2 and B3, the same chart (6 meshes) is repeated 23 times on one weave repeat.
For bar B1, the same chart (6 meshes) is repeated 15 times, in other words on 90 meshes, with the value D1 of the dedicated speed constant and positive.
Then, after a transition mesh, the chart (0-0) is repeated 45 times, in other words on 45 meshes, with the value D1 tending towards 0. This part of the weave repeat is illustrated in
Finally, the weave repeat for bar B1 ends with two transition meshes.
Thus, during a defined period of the weave repeat, in other words during a defined number of meshes, namely on the first 90 meshes of the weave repeat in the present example, the three bars B1, B2 and B3 are supplied with yarns at dedicated run-in rates which all have constant and positive values, and which are preferably all greater than or equal to 1,000 mm/rack, and the three bars produce the substantially plane base sheet of the knit.
Then, after a transition mesh, the value of the dedicated run-in D1 of bar B1 is reduced so as to tend towards 0 across a defined number of meshes, namely 45 meshes in the present example. During these 45 meshes, the respective dedicated run-in rates of the other two bars B2 and B3 continue to produce their respective parts of the knit of the base sheet. Since the latter cannot be generated in the direction of production of the knit on account of the value of the run-in D1 of bar B1 tending towards 0, it extends perpendicularly with respect to the direction of production of the knit and forms a fold.
Once the 45 meshes have been produced, and after two transition meshes, the weave repeat is recommenced from the start. Thus, the dedicated run-in D1 resumes its initial positive value greater than or equal to 1,000 mm/rack, and the three bars resume their respective productions of the knit in the direction of production of the knit and they again form the substantially plane base sheet, until the next variation of the value of D1 and the production of the following fold.
A knit is thereby obtained which comprises a base sheet and a succession of substantially perpendicular folds. In
To produce a prosthesis according to the invention from the knit 1 obtained above, the knit 1 is then cut in the area of its base sheet 2, on each side of a perpendicular fold 3, along the cutting lines 5 indicated by dot-and-dash lines, this step being indicated schematically in
A knitted structure 6, as shown in
Thus, the knitted structure 6 forming the T-shaped skeleton of the prosthesis according to the invention is made in one piece, and there is no area of weakness created at the join 9 between the first portion 7 and the second portion 8.
Moreover, the knitted structure of the present example is composed of monofilament yarns. Thus, its stability and the retention of its T shape in the absence of external stress are particularly excellent. Moreover, the three bars B1-B3 above are all threaded with monofilament yarns of one and the same biocompatible material, namely polylactic acid (PLA), the yarns of bar B1 having a mean diameter greater than the mean diameter of the yarns of bars B2 and B3. This results in optimal continuity of the properties of strength of the two portions of the knitted structure in the area of the joining line of said two portions.
Therefore, when the knitted structure 6 is stressed mechanically in the direction of production of the knit (see
The knitted structure 6 can be used as it is as a prosthesis for reinforcing the abdominal wall.
The knitted structure 6 can be subjected to one or more steps that are customary in the manufacture of a prosthesis, for example thermosetting, washing, cutting, thermoforming.
In one embodiment, and with reference to
The surgeon can then suture the second portion 8 of the prosthesis 10 to the muscles of the abdominal wall 101.
The prosthesis 10 thus implanted is able to reinforce the abdominal wall and reduce the risk of occurrence of a hernia after an incision has been made in the abdominal wall for the requirements of a surgical intervention. In particular, since the knitted structure 6 forming the skeleton of the prosthesis 10 is made in one piece, the prosthesis shows no discontinuity in its performance at the join between the first portion 7 and the second portion 8. Therefore, the risks of the prosthesis tearing at this join under the effect of the pressures/forces applied to the prosthesis in the direction of its width are extremely limited.
| Number | Date | Country | Kind |
|---|---|---|---|
| 12/58973 | Sep 2012 | FR | national |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14421222 | Feb 2015 | US |
| Child | 15357436 | US |
