Prosthesis comprising a three-dimensional and openworked knit
11612472 · 2023-03-28
Assignee
Inventors
Cpc classification
C08L1/04
CHEMISTRY; METALLURGY
C08L5/08
CHEMISTRY; METALLURGY
A61L27/16
HUMAN NECESSITIES
C08L1/04
CHEMISTRY; METALLURGY
C08L89/06
CHEMISTRY; METALLURGY
A61F2250/0051
HUMAN NECESSITIES
C08L5/08
CHEMISTRY; METALLURGY
A61F2/0063
HUMAN NECESSITIES
A61L27/16
HUMAN NECESSITIES
C08L89/06
CHEMISTRY; METALLURGY
A61F2250/0031
HUMAN NECESSITIES
A61F2002/009
HUMAN NECESSITIES
International classification
A61F2/00
HUMAN NECESSITIES
A61L27/16
HUMAN NECESSITIES
Abstract
The present invention relates to a prosthesis (100) comprising an openworked three-dimensional knit (101) comprising a front face and a rear face, each face being formed with one or more laps of yarns defining pores on said face, the front face being bound to the rear face by connecting yarns defining a spacer, characterized in that the connecting yarns are distributed so that they define an entanglement of yarns crossing each other at the spacer, without obstructing the pores of the front and rear faces.
Claims
1. A method of treating a hernia defect comprising: introducing at least one openworked three-dimensional knit into a body of a patient, the at least one openworked three-dimensional knit including two opposite faces, a first face and a second face, each first and second face being formed with one or several laps of yarns defining pores on said first and second faces, said pores of the first face and the pores of the second face being substantially aligned on each other providing the knit with transparence, said first face being bound to said second face by connecting yarns defining a spacer, wherein the connecting yarns are distributed so that said connecting yarns define a crisscrossing set of yarns crossing each other at the spacer, without obstructing the pores of the two opposite faces, wherein the pores of the first face and the pores of the second face remain in the same relative position when the knit is subject to compressive forces thereby maintaining the transparence of the knit, and placing the at least one openworked three-dimensional knit at the hernial defect with the first face facing the abdominal cavity and the second face facing the abdominal wall.
2. The method of claim 1, wherein the connecting yarns are yarns from at least one lap from the laps forming the opposite faces.
3. The method of claim 1, wherein the connecting yarns are yarns from one or more laps dedicated to the formation of the spacer.
4. The method of claim 1, wherein the spacer has an X-profile.
5. The method of claim 1, wherein the first face includes r rows and n columns of stitches facing r′ rows and n′ columns of stitches of the second face, with at least one portion of the connecting yarns connecting a column n.sub.i of the n columns of stitches of the first face to a column (n.sub.i′+x) of n′ columns of stitches of the second face, wherein x ranges from 2 to 5, and connecting a column n.sub.j of the n columns of stitches of the first face to a column (n.sub.j′−x′) of n′ columns of stitches of the second face, wherein x′ ranges from 2 to 5.
6. The method of claim 5, wherein x=x′.
7. The method of claim 5, wherein x=x′=2.
8. The method of claim 5, wherein x is different from x′.
9. The method of claim 1, wherein the second face includes an additional textile layer attached thereto.
10. The method of claim 9, further comprising attaching the additional textile layer directly to the abdominal wall to promote cell colonization into the second face of the knit.
11. The method of claim 10, wherein the additional textile layer is a skirt including a central aperture.
12. The method of claim 1, wherein the first face includes an anti-adhesion coating thereon.
13. The method of claim 12, wherein the anti-adhesion coating is bioresorbable.
14. The method of claim 13, wherein the anti-adhesion coating is in the form of a bioresorbable textile.
15. The method of claim 14, wherein the bioresorbable textile includes oxidized cellulose.
16. The method of claim 13, wherein the anti-adhesion coating is in the form of a bioresorbable film.
17. The method of claim 13, wherein the anti-adhesion coating is a film includes one or more of collagen, glycerol or chitosan.
18. The method of claim 9, wherein the openworked three-dimensional knit is in the form of a continuous part having a periphery, the additional textile layer being provided with a central aperture, and the first face covered with an anti-adhesion coating.
19. A method of treating a hernia defect comprising: introducing at least one openworked three-dimensional knit into a body of a patient, the at least one openworked three-dimensional knit including two opposite faces, a first face and a second face, each first and second face being formed with one or several laps of yarns defining pores on said first and second faces, said first face being bound to said second face by connecting yarns defining a spacer, wherein the connecting yarns are distributed so that said connecting yarns define a crisscrossing set of yarns crossing each other at the spacer, without obstructing the pores of the two opposite faces, said second face including an additional textile layer attached thereto, placing the at least one openworked three-dimensional knit at the hernial defect with the first face facing the abdominal cavity and the second face facing the abdominal wall, and attaching the additional textile layer directly to the abdominal wall to promote cell colonization into the second face of the knit.
20. The method of claim 19, wherein the additional textile layer is a skirt including a central aperture.
21. The method of claim 19, wherein the first face includes an anti-adhesion coating thereon.
Description
(1) The invention will be better understood from the detailed description and the examples which follow, as well as with the figures wherein:
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9) With reference to
(10) In the illustrated example, the knit 101 is in the form of a round part and has a circular periphery 101a. The prosthesis 100 further comprises a textile layer 103, having a periphery 103a substantially identical with that of the knit 101. The textile layer 103 is attached through its periphery 103a to the periphery 101a of the knit 101, and it has a central aperture 104: the textile layer 103 thereby forms a free skirt 105. During the implantation of the prosthesis 100 at a defect of the abdominal wall, for example in the treatment of a hernia, the surgeon may suture this free skirt 105 to the abdominal wall in order to effectively attach the prosthesis 100.
(11) The prosthesis 100 further comprises an anti-adhesion coating in the form of a film 106 covering the rear face of the knit 101. In the illustrated example, the film 106 slightly juts out from the peripheries (101a, 103a) of the knit 101 and of the textile layer 103. Preferably, the film is obtained from a mixture of oxidized collagen and glycerol as described in U.S. Pat. Nos. 6,451,032, 6,165,488 and 6,391,939.
(12) Such a film 106 prevents the formation of post-surgical fibrous adhesions.
(13) By the properties of the three-dimensional knit as mentioned in Examples 1, 2 and 3 below, the prosthesis according to the invention as described in
(14) In
(15) The present application also describes a method for treating hernia consisting of providing a prosthesis according to the invention and of implanting it at the hernial defect: for example the face of the knit covered with the anti-adhesion coating is placed facing the abdominal cavity while the non-covered face, either provided or not with an additional textile layer forming a skirt, is placed facing the abdominal wall, with view to cell recolonization. When the prosthesis comprises a skirt as described above, the surgeon may directly attach the skirt of the prosthesis to the abdominal wall by means of sutures or clamps.
EXAMPLE 1
(16) A knit suitable for the prosthesis according to the invention is produced with 50 decitex multi-filament polyester yarns, number of filaments per yarn: 22.
(17) The knit is produced on a two-bed Rachel knitting machine with 6 threaded guide bars 1 full stitch, 1 empty stitch, according to the following weave according to the ISO 11676 standard:
(18) BAV1: 1.0.1.1/1.2.1.1/1.0.1.1/2.3.2.2/2.1.2.2/2.3.3.3/4.5.4.4/4.3.4.4/4.5.4.4/3.2.3.3/3.4.3.3/3.2.2.2//
(19) BAV2: 4.5.4.4/4.3.4.4/4.5.4.4/3.2.3.3/3.4.3.3/3.2.2.2/1.0.1.1/1.2.1.1/1.0.1.1/2.3.2.2/2.1.2.2/2.3.3.3//
(20) BE1: 1.1.1.0/1.0.1.0/1.0.1.1/1.1.1.0/2.3.2.3/2.3.2.2/2.2.2.3/2.3.2.3/2.3.2.2/2.2.2.3/1.0.1.0/1.0.1.1//
(21) BE2: 2.2.2.3/2.3.2.3/2.3.2.2/2.2.2.3/1.0.1.0/1.0.1.1/1.1.1.0/1.0.1.0/1.0.1.1/1.1.1.0/2.3.2.3/2.3.2.2//
(22) BAR1: 2.2.1.0/1.1.1.2/1.1.1.0/1.1.2.3/2.2.2.1/2.2.2.3/3.3.4.5/4.4.4.3/4.4.4.5/4.4.3.2/3.3.3.4/3.3.3.2//
(23) BAR2: 3.3.4.5/4.4.4.3/4.4.4.5/4.4.3.2/3.3.3.4/3.3.3.2/2.2.1.0/1.1.1.2/1.1.1.0/1.1.2.3/2.2.2.1/2.2.2.3//
(24) This weave is illustrated in
(25) In the present example the yarns of the BAV1 and BAV2 bars form the front face, the yarns of the BE1 and BE2 bars form the spacer and the yarns of the BAR1 and BAR2 bars form the rear face. In the present example, the connecting yarns are therefore yarns from laps dedicated to the formation of the spacer, i.e. the laps obtained with the BE1 and BE2 bars.
(26) The weave followed for the front face produces a front face comprising pores. Also, the weave followed for the rear face produces a face comprising pores. The pores of the front face are substantially facing the pores of the rear face.
(27) As this appears in
(28) The yarn of the BE2 bar is also involved in the formation of the spacer, symmetrically to the yarn of the BE1 bar.
(29) Thus, the spacer obtained is formed with connecting yarns which regularly cross each other.
(30) The thereby obtained spacer is particularly resistant to compressive forces tending to press the front face onto the rear face. Subject to such forces, the spacer does neither collapse nor lie down thereby retaining its three-dimensional structure to the knit.
(31) The obtained knit has the following properties:
(32) 1°) Thickness: 1.7 mm
(33) By its structure, the knit of the present example substantially retains its height even when it is subject to a compressive force tending to press its front face onto the rear face.
(34) 2°) Transparence and size of the pores for both front and rear faces: small pores (width×height): 2.0×2.4 mm large pores (width×height): 2.1×2.5 mm
(35) By the structure of the knit of the present example, the pores of the front face remain facing the pores of the rear face, even when the knit is subject to a compressive force tending to compress its front face onto its rear face.
(36)
(37) 3°) Suture strength, as measured according to the NF S94-8012007 standard “Reinforcement implants set into place via a vaginal route for an urge and/or prolapsus urinary incontinence cure for pelvic organs—pre-clinical tests and clinical tests”—§ 5.2.3, 5 samples 50×100 mm, USP 2/0 suture yarn, crosshead speed: 100 mm/min in the warp direction: 30±3 N in the weft direction: 46±2 N
(38) The above test is conducted on a tensile testing machine Hounsfield H5KS-SN 0589.
(39) The knit retains its three-dimensional structure even when it is subject to compressive forces tending to press its front face onto its rear face.
(40) This knit is useful for manufacturing reinforcement prosthesis for example for repairing hernias. It is sufficient to cut out the intended shape, for example a rectangular (see
EXAMPLE 2
(41) A knit suitable for the prosthesis according to the invention is produced with 88 dtex monofilament polyester yarns.
(42) The knit is produced on a two-bed Rachel knitting machine with 4 threaded guide bars, 1 full stitch, 1 empty stitch, according to the following weave, according to the ISO 11676 standard:
(43) BAV:4.3.2.2/1.0.1.1/1.2.1.1/1.0.1.1/1.2.1.1/1.0.1.1/1.2.3.3/4.5.4.4/4.3.4.4/4.5.4.4/4.3.4.4/4.5.4.4//
(44) BE1:1.2.3.3/4.5.1.2/4.3.4.4/4.5.4.4/4.3.4.4/4.5.4.4/4.3.2.2/1.0.4.3/1.2.1.1/1.0.1.1/1.2.1.1/1.0.1.1//
(45) BAR1:4.4.4.3/2.2.1.0/1.1.1.2/1.1.1.0/1.1.1.2/1.1.1.0/1.1.1.2/3.3.4.5/4.4.4.3/4.4.4.5/4.4.4.3/4.4.4.5//
(46) BAR2:1.1.1.2/3.3.4.5/4.4.4.3/4.4.4.5/4.4.4.3/4.4.4.5/4.4.4.3/2.2.1.0/1.1.1.2/1.1.1.0/1.1.1.2/1.1.1.0
(47) This weave is illustrated in
(48) In the present example, the yarns of the BAV and BE1 bars form the front face, the yarns of the BAR1 and BAR2 bars form the rear face. In the present example, the connecting yarns are therefore yarns from a lap of the front face, i.e. the lap obtained with the BE1 bar. Thus, in the present example, there are no laps of connecting yarns dedicated to the formation of the spacer.
(49) The weave followed for the front face produces a front face comprising pores. Also, the weave followed for the rear face produces a face comprising pores. The pores of the front face are substantially facing the pores of the rear face.
(50) As this appears in
(51) Next this yarn connects the 8.sup.th row and column n of the front face to row 8′, column (n′+3) of the rear face (see the arrow in the figure). By doing this, it rejoins the front face to the rear face obliquely and not perpendicularly to these faces and x is equal to 3. Next, the yarn connects row 8′, column (n′+3) of the rear face to row 9, column (n+1) of the front face and here, x′ is equal to 2.
(52) Thus, the obtained spacer is formed with connecting yarns which regularly cross each other thereby generating an optimum entanglement of yarns not parallel with each other.
(53) The thereby obtained spacer is particularly resistant to compressive forces tending to press the front face onto the rear face. Subject to such forces, the spacer neither collapses nor lies down parallel to the front and rear faces, thereby retaining its three-dimensional knitted structure.
(54) This knit is useful for manufacturing reinforcement prosthesis for example for repairing hernias. It is sufficient to cut out the intended shape, for example a rectangular (see
EXAMPLE 3
(55) A knit suitable for the prosthesis according to the invention is produced with 88 dtex monofilament polyester yarns.
(56) The knit is produced on a two-bed Rachel knitting machine with 4 threaded guide bars, 1 full stitch, 1 empty stitch, according to the following weave, according to the ISO 11676 standard:
(57) BAV:4.3.2.2/1.0.1.1/1.2.1.1/1.0.1.1/1.2.1.1/1.0.1.1/1.2.3.3/4.5.4.4/4.3.4.4/4.5.4.4/4.3.4.4/4.5.4.4//
(58) BE1:1.2.3.3/4.5.2.1/4.3.4.5/4.5.4.4/4.3.4.5/4.5.4.4/4.3.2.2/1.0.3.4/1.2.1.0/1.0.1.1/1.2.1.0/1.0.1.1//
(59) BAR1:4.4.4.3/2.2.1.0/1.1.1.2/1.1.1.0/1.1.1.2/1.1.1.0/1.1.1.2/3.3.4.5/4.4.4.3/4.4.4.5/4.4.4.3/4.4.4.5//
(60) BAR2:1.1.1.2/3.3.4.5/4.4.4.3/4.4.4.5/4.4.4.3/4.4.4.5/4.4.4.3/2.2.1.0/1.1.1.2/1.1.1.0/1.1.1.2/1.1.1.0
(61) This weave is illustrated in
(62) In the present example, the yarns of the BAV and BE1 bars form the front face, the yarns of the BAR1 and BAR2 bars form the rear face. In the present example, the connecting yarns are therefore yarns from a lap of the front face, i.e. the lap obtained with the BE1 bar. Thus, in the present example, there are no laps of connecting yarns dedicated to the formation of the spacer.
(63) The weave followed for the front face produces a front face comprising pores. Also, the weave followed for the rear face produces a face comprising pores. The pores of the front face are substantially facing the pores of the rear face.
(64) As this appears in
(65) This yarn also connects the 8.sup.th row and column n of the front face to row 8′, column (n′+3) of the rear face. By doing this, it rejoins the front face to the rear face obliquely and not perpendicularly to these faces and x is equal to 3. Next, the yarn connects row 8′, column (n′+3) of the rear face to row 9, column (n+1) of the front face and here, x′ is equal to 2.
(66) Thus, the obtained spacer comprises connecting yarns which regularly cross each other thereby generating an optimum entanglement of yarns not parallel with each other.
(67) In addition, in the present example, the yarn of the BE1 bar forms additional connections between the front face and the rear face, in which the connecting yarns do not cross each other: these additional connections may be seen on
(68) Indeed, at row no 3 and at column (n+3), the yarn connects the front face to row no 3′ of the rear face and to the column (n′+4). By doing this, it rejoins the front face to the rear face obliquely and not perpendicularly to these faces: in this example, the yarn is shifted by one column. This yarn then connects row 3′, column (n′+4) of the rear face to row 4, column (n+4) of the front face. By doing this it rejoins the rear face to the front face perpendicularly to these faces, with no shift of column. The same phenomenon is repeated starting at row 5.
(69) In addition, at row no 9 and at column (n+1), the yarn connects the front face to row no 9′ of the rear face and to the column n′. By doing this, it rejoins the front face to the rear face obliquely and not perpendicularly to these faces: in this example, the yarn is shifted by one column. This yarn then connects row 9′, column n′ of the rear face to row 10, column n of the front face. By doing this it rejoins the rear face to the front face perpendicularly to these faces, with no shift of column. The same phenomenon is repeated starting at row 11.
(70) Such additional connections between the front and the rear face, with connecting yarns which are yarns from a lap of the front face, bring additional resistance to compressive force to the knitted structure.
(71) The thereby obtained spacer is particularly resistant to compressive forces tending to press the front face onto the rear face. Subject to such forces, the spacer neither collapses nor lies down parallel to the front and rear faces, thereby retaining its three-dimensional knitted structure.
(72) The obtained knit has the following properties:
(73) 1°) Thickness: 1.3 mm
(74) By its structure, the knit of the present example substantially retains its height even when it is subject to a compressive force tending to press its front face onto the rear face.
(75) 2°) Transparence and size of the pores for both front and rear faces: pores (width×height): 2.0×3.3 mm
(76) By the structure of the knit of the present example, the pores of the front face remain facing the pores of the rear face, even when the knit is subject to a compressive force tending to compress its front face onto its rear face.
(77)
(78) 3°) Suture strength, as measured according to the NF S94-8012007 standard “Reinforcement implants set into place via a vaginal route for an urge and/or prolapsus urinary incontinence cure for pelvic organs—pre-clinical tests and clinical tests”—§ 5.2.3, 5 samples 50×100 mm, USP 2/0 suture yarn, crosshead speed: 100 mm/min in the warp direction: 46±3 N in the weft direction: 50±6 N
(79) The above test is conducted on a tensile testing machine Hounsfield H5KS-SN 0589.
(80) The knit retains its three-dimensional structure even when it is subject to compressive forces tending to press its front face onto its rear face.
(81) This knit is useful for manufacturing reinforcement prosthesis for example for repairing hernias. It is sufficient to cut out the intended shape, for example a rectangular (see