Implant for parastomal hernia
10368971 · 2019-08-06
Assignee
Inventors
- Linda Spinnler (Pommiers, FR)
- Julie Lecuivre (Jassans-Riottier, FR)
- Alfredo Meneghin (Laval, FR)
- Michel Therin (Lyons, FR)
Cpc classification
A61F2/0063
HUMAN NECESSITIES
International classification
A61F2/00
HUMAN NECESSITIES
Abstract
An implant for the prevention or treatment of a hernia in the proximity of an organ stoma formed in an abdominal wall includes a porous structure having a surface intended to face the abdominal cavity covered by a first film of anti-adhesive material. The porous structure includes a first part intended to be in contact with a stoma organ and having a first thickness, and a second part having a second thickness greater than the first thickness, the first part including a surface intended to face the abdominal wall covered by a second film of anti-adhesive material.
Claims
1. A method of forming an implant for the prevention or treatment of a hernia formed in an abdominal wall in the proximity of a stoma of an organ comprising: preparing an implant having a porous structure composed of a textile having a two-dimensional knit corresponding to a first part of the porous structure and one or more three-dimensional knits corresponding to a second part of the porous structure, wherein preparing the two-dimensional knit corresponding to the first part of the porous structure includes knitting at least one yarn using two-guide bars A and B according to the following pattern: Bar A: 4-4-5-4/4-4-4-3/3-3-2-1/1-1-0-1/1-1-1-2/2-2-3-4// Bar B: 1-1-0-1/1-1-1-2/2-2-3-4/4-4-5-4/4-4-4-3/3-3-2-1//; pouring a solution of anti-adhesive material into a mold; applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the one or more three-dimensional knits; and drying the porous structure.
2. The method according to claim 1, wherein the step of applying the first part of the porous structure on the solution further comprises substantially completely impregnating the two-dimensional knit with the solution.
3. The method according to claim 1, further comprising the step of applying the solution to a second surface opposite the single surface of the two-dimensional knit corresponding to a first part of the porous structure.
4. The method according to claim 1, wherein the at least one yarn of the two-dimensional knit corresponding to the first part of the porous structure includes a monofilament yarn including polyethylene terephthalate.
5. The method according to claim 1, wherein preparing the one or more three-dimensional knits corresponding to the second part of the porous structure includes knitting at least one yarn using two-guide bars D and E according to the following pattern: Bar D: 0-1-1-1/1-2-2-2/3-4-4-4/5-4-4-4/4-3-3-3/2-1-1-1// Bar E: 5-4-4-4/4-3-3-3/2-1-1-1/0-1-1-1/1-2-2-2/3-4-4-4//.
6. The method according to claim 5, wherein the at least one yarn of the one or more three-dimensional knits corresponding to the second part of the porous structure includes a monofilament yarn including polyethylene terephthalate.
7. The method according to claim 5, wherein preparing the implant further includes connecting the two-dimensional knit corresponding to a first part of the porous structure to the one or more three-dimensional knits corresponding to the second part of the porous structure via knitting at least one additional yarn using a single guide bar C according to the following pattern: Bar C: 1-0-1-0/1-1-1-1/1-1-1-1//.
8. The method according to claim 1, wherein preparing the one or more three-dimensional knits corresponding to the second part of the porous structure includes knitting at least one yarn using two-guide bars D and E according to the following pattern: Bar D: 1-1-1-1/1-2-2-2/3-4-4-4/5-4-4-4/4-3-3-3/2-1-1-1// Bar E: 5-4-3-4/4-3-3-3/2-1-1-1/0-1-2-1/1-2-2-2/3-4-4-4//.
9. The method according to claim 8, wherein the at least one yarn of the second part includes a monofilament yarn including polyethylene terephthalate.
10. The method according to claim 1, wherein preparing the implant includes a textile wherein the two-dimensional knit corresponding to the first part of the porous structure is a central strip separating two lateral strips of the three-dimensional knits corresponding to the second part of the porous structure.
11. The method according to claim 1, wherein preparing the implant includes a textile wherein the two-dimensional knit corresponding to the first part of the porous structure has a first thickness and the one or more three-dimensional knits corresponding to the second part of the porous structure has a second thickness greater than the first thickness.
12. The method according to claim 1, wherein preparing the implant includes a textile wherein the one or more three-dimensional knits corresponding to the second part of the porous structure includes a second surface intended to face the abdominal wall having elements chosen from loops, barbs, hooks, threads, or clips for fastening the second part to the abdominal wall.
13. The method according to claim 1, wherein pouring the solution of anti-adhesive material into the mold includes a solution which includes materials chosen from among collagens, oxidized celluloses, polyarylates, trimethylene carbonates, caprolactones, dioxanones, glycolic acid, lactic acid, glycolides, lactides, polysaccharides, chitosans, polyglucuronic acids, hyaluronic acids, dextrans, polytetrafluoroethylene, polyethylene glycols, polysiloxanes, polyurethanes, stainless steels and their mixtures.
14. The method according to claim 1, wherein pouring the solution of anti-adhesive material into the mold includes a solution which includes materials chosen from collagens, chitosans, and their mixtures.
15. The method according to claim 1, wherein applying the first part of the porous structure on the solution such that the solution extends past an edge of the porous structure.
16. The method according to claim 1, wherein preparing the implant further includes a textile including at least one orifice formed at about center of the first part of the porous structure to provide a passage for the stoma organ during implantation of the implant.
17. The method according to claim 1, wherein preparing the implant further includes a textile including at least one orifice being offset relative to the center of the implant.
18. A method of forming an implant for the prevention or treatment of a hernia formed in an abdominal wall in the proximity of a stoma of an organ comprising: preparing an implant having a porous structure composed of a textile having a two-dimensional knit corresponding to a first part of the porous structure and one or more three-dimensional knits corresponding to a second part of the porous structure, wherein the one or more three-dimensional knits corresponding to the second part of the porous structure include a second surface intended to face the abdominal wall having elements chosen from loops, barbs, hooks, threads, or clips for fastening the second part to the abdominal wall; pouring a solution of anti-adhesive material into a mold; applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the one or more three-dimensional knits; and drying the porous structure.
19. A method of forming an implant for the prevention or treatment of a hernia formed in an abdominal wall in the proximity of a stoma of an organ comprising: preparing an implant having a porous structure composed of a textile having a two-dimensional knit corresponding to a first part of the porous structure and one or more three-dimensional knits corresponding to a second part of the porous structure; pouring a solution of anti-adhesive material into a mold, the solution including materials selected from the group consisting of collagens, oxidized celluloses, polyarylates, trimethylene carbonates, caprolactones, dioxanones, glycolic acid, lactic acid, glycolides, lactides, polysaccharides, chitosans, polyglucuronic acids, hylauronic acids, dextrans, polytetrafluoroethylene, polyethylene glycols, polysiloxanes, polyurethanes, stainless steels and their mixtures; applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the one or more three-dimensional knits; and drying the porous structure.
20. A method of forming an implant for the prevention or treatment of a hernia formed in an abdominal wall in the proximity of a stoma of an organ comprising: preparing an implant having a porous structure composed of a textile having a two-dimensional knit corresponding to a first part of the porous structure and one or more three-dimensional knits corresponding to a second part of the porous structure; pouring a solution of anti-adhesive material into a mold, the solution including materials selected from the group consisting of collagen, chitosan, and their mixtures; applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the one or more three-dimensional knits; and drying the porous structure.
21. A method of forming an implant for the prevention or treatment of a hernia formed in an abdominal wall in the proximity of a stoma of an organ comprising: preparing an implant having a porous structure composed of a textile having a two-dimensional knit corresponding to a first part of the porous structure and one or more three-dimensional knits corresponding to a second part of the porous structure, the textile including at least one orifice formed at about center of the first part of the porous structure to provide a passage for the stoma organ during implantation of the implant; pouring a solution of anti-adhesive material into a mold; applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the one or more three-dimensional knits; and drying the porous structure.
22. A method of forming an implant for the prevention or treatment of a hernia formed in an abdominal wall in the proximity of a stoma of an organ comprising: preparing an implant having a porous structure composed of a textile having a central strip of a two-dimensional knit corresponding to a first part of the porous structure separating two lateral strips of three-dimensional knits corresponding to a second part of the porous structure; pouring a solution of anti-adhesive material into a mold; applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the three-dimensional knits; and drying the porous structure.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The principles of the present disclosure, and variants thereof, will become evident from the following detailed description and from the attached drawings, in which:
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
DETAILED DESCRIPTION OF THE EMBODIMENTS
(15) Referring to
(16) As seen in
(17) The implant 10 shown in
(18) In one example not shown, the implant has a generally round shape. Its diameter may then be from about 5 to about 20 cm, for example.
(19) Referring to
(20)
(21) Thus, as seen in
(22) By contrast, in regards to the second part 15 of the textile, its first surface 12, intended to be placed facing the abdominal wall, is not covered by film 16 of anti-adhesive material. This surface 12 will be referred to hereinbelow as the open surface of the second part 15 of the textile. By contrast, the second surface 13 intended to be placed facing the abdominal cavity, is covered by film 16 of anti-adhesive material. This surface 13 will be referred to hereinbelow as the closed surface of the second part of the textile. Thus, the film 16 of anti-adhesive material penetrates only superficially into the second part 15 of the textile, in the area of its closed surface 13, leaving open the porosity of the first open surface 12 of the second textile part 15.
(23)
(24) Bar A: 4-4-5-4/4-4-4-3/3-3-2-1/1-1-0-1/1-1-1-2/2-2-3-4//
(25) Bar B: 1-1-0-1/1-1-1-212-2-3-4/4-4-5-4/4-4-4-313-3-2-1//
(26) The yarn used may be a monofilament yarn of polyethylene terephthalate, having a diameter of about 0.08 mm and a titre of about 69 dtex. The knit thus formed includes two opposite surfaces but is free of connecting sheets between its two opposite surfaces. It is a two-dimensional knit according to the present application.
(27) The thickness of the first part of the textile formed from such a knit is approximately 0.25 mm.
(28) In the example shown, the knitting used for the first part of the textile creates pores, in embodiments with dimensions that can range from about 0.1 to about 3 mm, in embodiments from about 1.5 to about 2 mm. At the moment of implantation, these pores are not visible, nor are they accessible to tissue colonization, because the whole of the first part of the textile is confined in the film 16 of anti-adhesive material. However, after a few days, as the film of anti-adhesive material is absorbed and disappears after performing its function of limiting and/or avoiding formation of adhesions during the first 10 days following the implantation operation, the pores of the first part 14 of the textile become accessible to tissue colonization. When a yarn of polyethylene terephthalate is used for producing the two-dimensional knit, this knit is non-bioabsorbable and remains permanently at the implantation site.
(29) In another embodiment of the present disclosure, the first part 14 of the textile is made of a bioabsorbable material that is absorbed more slowly than the bioabsorbable material constituting the film 16 of anti-adhesive material.
(30) As is shown in
(31) Thus, as will be seen clearly from
(32) The second part 15 of the textile, of which the thickness is greater than that of the first part 14 of the textile, can be a knit which is obtained on a warp knitting machine or double-bed raschel machine and which has two opposite surfaces connected to each other by connecting yarns, that is to say a three-dimensional knit according to the present application. For example, a first surface of the knit is produced with the two guide bars A and B already mentioned above for producing the first part 14 of textile, these being threaded identically and with the same charts as above. The second surface of the knit is produced with two supplementary guide bars D and E, threaded with one guide full, one guide empty, using the knitting structure shown in
(33) Bar D: 0-1-1-1/1-2-2-2/3-4-4-4/5-4-4-4/4-3-3-3/2-1-1-1//
(34) Bar E: 5-4-4-4/4-3-3-3/2-1-1-1/0-1-1-1/1-2-2-2/3-4-4-4//
(35) The connection of the two surfaces can be effected, for example, by hooking one loop in two, or in three, or in four, or in five, or in six of one of the bars D or E, whose knitting structure will be adapted. For example, in one embodiment of the present disclosure, the connection of the two surfaces is effected by hooking one loop in three of the bar E, which thus becomes bar E, with the knitting structure shown in
(36) Bar E: 5-4-3-4/4-3-3-3/2-1-1-1/0-1-2-1/1-2-2-2/3-4-4-4//
(37) In another embodiment, the connection of the two surfaces can be effected with the aid of a fifth guide bar C, with the knitting structure shown in
(38) Bar C: 1-0-1-0/1-1-1-1/1-1-1-1//
(39) Thus, when the first part 14 of the textile is in the form of a central strip separating two lateral strips of the second part 15 of the textile, as is shown in
(40) With the guide bars A, B, D and E described above:
(41) the whole of the first surface 13 of the textile 11 is produced with the two guide bars A and B,
(42) along a first length, corresponding to the first lateral strip of the second part 15 of the textile, the guide bars D and E are threaded one guide full, one guide empty, in order to produce the second surface of the three-dimensional knit forming the second part 15 of the textile,
(43) then, along the length corresponding to the width of the central strip of the first part 14 of the textile, the guide bars D and E are left empty in order to form the two-dimensional knit,
(44) finally, along a length corresponding to the second lateral strip of the second part 15 of the textile, the guide bars D and E are again threaded one guide full, one guide empty, in order to produce the second surface of the three-dimensional knit forming the second part 15 of the textile.
(45) In such a case, the optional fifth guide bar C is threaded only in the zones of the three-dimensional knit.
(46) Finally, in order to obtain a smooth join between the three-dimensional knit forming the second part 15 of the textile and the two-dimensional knit forming the first part 14 of the textile, it is possible to use, still on the same knitting machine, a supplementary guide bar F in order to finish the edges of the three-dimensional knits, threaded in the area of these edges, according to the knitting structure shown in
(47) Bar F: 1-0-1-1/1-2-1-1//
(48) A monofilament yarn may be chosen to produce the second part 15 of the textile. This is because multifilament yarns may pose greater risks of bacteria developing in the interstices present between the various filaments of the yarn.
(49) The yarn used may be a monofilament yarn of polyethylene terephthalate, with a diameter of approximately 0.08 mm and titre of approximately 69 dtex.
(50) The thickness of the second part 15 of the textile, produced in the form of the three-dimensional knit described above, is approximately 1.50 mm.
(51) As will be seen from
(52) The superficial covering of the surface of the second part 15 of textile intended to be placed facing the abdominal cavity can be carried out using any method within the purview of a person skilled in the art, for example using the method described in the application WO99/06080.
(53) The material used for the film 16 of anti-adhesive material can, for example, be collagen prepared in the manner described in the application WO99/06080.
(54) The film 16 of anti-adhesive material may be applied to the surface of the textile 11 intended to be placed facing the abdominal cavity, in the following way:
(55) The solution of collagen is poured into a mould having the external dimensions desired for the film. The textile produced above is then applied to this solution, at the centre of the mould, the surface to be covered being placed on the solution of collagen. The solution of collagen then penetrates into the textile by capillary force, completely coating the first part of textile and covering the latter on the two opposite surfaces of the two-dimensional knit forming it, and penetrating only by a small distance into the thickness of the second part of textile, thus creating a superficial film for this three-dimensional part. Once the collagen has dried, the film is cut around the textile using a scalpel.
(56) Alternatively, the covering/coating method described in WO2004/043294 can be used.
(57) In another embodiment not shown here, the film 16 only superficially covers the surface of the first part of the textile, intended to be placed facing the abdominal cavity, and does not encompass the two opposite surfaces of this first part of the textile. In such a case, the surface of the first part of the textile intended to be placed facing the abdominal wall is covered with a second film of anti-adhesive material. Thus, each of the two opposite surfaces of the first part of the textile is covered by a smooth and continuous film of anti-adhesive material. Covering methods that can be used to form this second film are also described in WO2004/043294.
(58)
(59) In one embodiment not shown here, the orifice 17 is offset relative to the centre of the implant 10. It is also possible to have several orifices, depending on the surgery envisaged.
(60) Thus, in
(61) It is possible to fix the implant 10 to the abdominal wall 7 using staples or sutures. In addition, or alternatively, the open surface of the second part 15 of the textile can intrinsically include barbs or loops, which will facilitate its natural attachment to the abdominal wall. Such an affixing knit is described in the application WO01/81667.
(62) Finally, the second surface of the textile, completely covered by film 16 of anti-adhesive material, is situated facing the abdominal cavity 8. Thus, the hollow and fragile organs, the viscera, are not damaged by the implant.
(63)
(64) As will be seen from these two figures, the part 3c of the colon faces and is able to come into contact with the first part 14 of the textile covered on its two opposite surfaces by the film 16 of anti-adhesive material. Thus, neither the part 3c of the colon, situated between the implant 10 and the abdominal wall 7, nor the part 3d of the colon corresponding to the second length of the bend and able to lie under the implant 10 in the area of the abdominal cavity 8, risks being damaged by the implant 10. This is because the parts 3c and 3d of the colon 3 are each facing a surface of the first part 14 of textile covered by a film 16 of anti-adhesive material. Moreover, the relatively small thickness E1 of this first part 14 of textile permits flexible and atraumatic support of the colon 3.
(65) In an indirect stoma of this kind, the implant 10 may act like a hammock for the part 3c of the colon 3, and the implant 10 can be fixed to the abdominal wall 7 via the open surface of the second part 15 of the textile placed facing the abdominal wall 7.
(66) The present disclosure also relates to a method for treatment or prevention of a hernia in the proximity of a stoma formed in the skin, including the step of implanting an implant of the type described above in the area of the stoma. In one embodiment of the present disclosure, the implant is fixed to the abdominal wall. The implant described above can be implanted by open surgery or by laparoscopy.
(67) The implant according to the present disclosure is used in particular in the treatment of parastomal hernias. It is able to support and/or protect the organs that are to be treated, such as the colon or ureters, without damaging them, while at the same time effectively strengthening the wall in which the stoma is formed, such as the abdominal wall, irrespective of the type of stoma formed, i.e. direct stoma or indirect stoma.