SURGICAL TEXTILE WITH BARBS AND LOOPS
20210322145 · 2021-10-21
Inventors
Cpc classification
A61F2/0063
HUMAN NECESSITIES
A61F2220/0016
HUMAN NECESSITIES
International classification
A61F2/00
HUMAN NECESSITIES
Abstract
The present invention relates to a surgical textile (1) comprising an arrangement of biocompatible yarns defining a first face (2) and a second face (3) of the textile, the second face opposite the first face, the textile being provided at least on an area of a surface of one of its faces with a plurality of barbs (4) showing substantially a first length L1, measured perpendicularly to that surface, characterised in that said area of said surface is further provided with a plurality of loops (5), said loops showing substantially a second length L2, measured perpendicularly to that surface, where L2 is greater than L1. The invention further relates to a process for manufacturing such a textile.
Claims
1-18. (canceled)
19. A surgical textile comprising an arrangement of biocompatible yarns defining a first face and a second face of the textile, the second face opposite the first face, the textile being provided at least on an area of a surface of one of its faces with a plurality of barbs showing substantially a first length L1, measured perpendicularly to that surface, characterized in that said area of said surface is further provided with a plurality of loops, said loops showing substantially a second length L2, measured perpendicularly to that surface, where L2 is greater than L1.
20. The surgical textile according to claim 19, wherein L2 is from 20% to 140% longer than L1.
21. The surgical textile according to claim 19, wherein L1 ranges from 0.5 mm to 1.0 mm and L2 ranges from 0.8 mm to 1.2 mm.
22. The surgical textile according to claim 19, wherein the barbs are made of a yarn having a diameter D1 and the loops are made of a yarn having a diameter D2, where D1 is greater than D2.
23. The surgical textile according to claim 22, wherein D1 is from 10% to 80% greater than D2
24. The surgical textile according to claim 22, wherein D1 ranges from 0.10 mm to 0.18 mm and D2 ranges from 0.09 mm to 0.17 mm.
25. The surgical textile according to claim 19, wherein the barbs are made of a yarn having a diameter D3 and the loops are made of a yarn having a diameter D4, where D4 is greater than D3.
26. The surgical textile according to claim 25, wherein D4 is from 10% to 80% greater than D3.
27. The surgical textile according to claim 25, wherein D4 is from 15% to 40% greater than D3.
28. The surgical textile according to claim 25, wherein D4 ranges from 0.10 mm to 0.18 mm and D3 ranges from 0.09 mm to 0.17 mm.
29. The surgical textile according to claim 19, wherein the barbs are made of a biodegradable material.
30. The surgical textile according to claim 19, wherein the barbs are made of heat-fusible monofilament yarn cuts.
31. The surgical textile according to claim 19, wherein the arrangement of yarns is a knit comprising i) one or more yarn(s) forming said first and second faces of said textile and said loops and ii) heat-fusible monofilament yarn cuts forming said barbs.
32. The surgical textile according to claim 19, wherein the loops and the barbs define looped zones and barbed zones organized according to patterns selected from stripes, concentric circles, concentric rectangles, concentric squares, quincunx, and combinations thereof.
33. A process for manufacturing a surgical textile comprising a first face and a second face, opposite the first face, comprising the following steps: A) knitting, on a Raschel knitting machine or a warp knitting machine, one or more several yarns according to a knitting pattern allowing the formation of said first and second faces of the textile and at least one heat-fusible monofilament yarn according to a knitting pattern allowing the formation of loops protruding outwards said first face on at least an area of the surface of said first face, said loops showing a length L2, measured perpendicularly to said surface, B) cutting, by melting, some of the loops formed at step A), each cut loop thus generating two barbs, each barb showing a length L1, measured perpendicularly to said surface, wherein L2 is greater than L1.
34. The process according to claim 33, wherein step B) is performed by heating a press to a temperature that causes the loops to melt and applying said heated press on said first face of the knit, said press being shaped and dimensioned so that only some of the loops are contacted by said press and are thus caused to melt.
35. The process according to claim 33, wherein in step A), two different heat-fusible monofilament yarns are used, a first heat-fusible monofilament yarn having a first diameter and generating first loops, and a second heat-fusible monofilament yarn having a second diameter and generating second loops, and in step B), only the first loops are cut by melting.
36. The process according to claim 35, wherein the first diameter is greater than the second diameter.
37. The process according to claim 35, wherein the second diameter is greater than the first diameter.
Description
[0075] The invention will be better understood from the following detailed description and figures, in which:
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[0092] With reference to
[0093] As appears from
[0094] In
[0095] As can be seen from
[0096] For example, L1 may range from 0.5 mm to 1.0 mm, preferably from 0.7 mm to 0.9 mm, and L2 may range from 0.8 mm to 1.2 mm, preferably from 0.9 mm to 1.1 mm.
[0097] The loops 5 of the textile 1 allow protecting the barbs 4 when the textile 1 is conveyed to an implantation site. During the time the textile 1 is moved within the surrounding tissues, the loops 5 prevent the barbs 4 to anchor into the tissues.
[0098]
[0099] As appears from
[0100] Once at the implantation site, the textile 1 is positioned so that its first face 2, provided with the barbs 4 and the loops 5, faces the outer surface 12a of the biological tissue 12 to which the textile 1 is intended to be fixed.
[0101] With reference to
[0102] The textile 1 allows therefore deactivating the barbs 4 during the time the textile 1 is conveyed to the implantation site, either through surrounding tissues, or in a folded or rolled configuration of the textile 1 in a trocar, and activating the barbs 4 when needed.
[0103] With reference to
[0104] With reference to
[0105] The deactivation of the barbs 4, as described above during the transport of the textile 1 within patient's body, also allows an easier deployment of the textile 1 once it has reached the implantation site. The deactivation of the barbs 4 by the loops 5 also allows the textile 1 to be detached and re-attached easily on the implantation site, so that the surgeon may reposition the textile 1 in order to fix it in the best position.
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[0109] In a second step, a press 8, shaped and dimensioned so as to show a specific relief 9, is heated to a temperature that causes the loops 5 to melt and is moved towards the first face 2 of the textile 1 according to arrow F shown on
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[0111] As appears from
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[0113] As appears from
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[0115] As appears from
EXAMPLES
Example 1
[0116] Surgical textiles have been prepared using one of the two following knitting patterns:
[0117] Knitting pattern A: [0118] Bar B1: unthreaded [0119] Bar B2: 1.0/0.1// [0120] Bar B3: 1.0/5.5/1.0/3.3// [0121] Bar B4: 2.1/5.5/3.4/0.0//
[0122] Knitting Pattern B: [0123] Bar B1: unthreaded [0124] Bar B2: 1.0/0.1// [0125] Bar B3: 1.0/7.7/6.6/7.7// [0126] Bar B4: 2.1/5.5/3.4/0.0//
[0127] Five surgical textiles of the invention have been prepared as follows:
[0128] KNIT 1: this knit was prepared using Knitting pattern A, with bars B2 and B3 being threaded with monofilament yarns of polyester terephthalate (PET) having a diameter of 0.08 mm. Bar B4 was threaded with a first heat-fusible monofilament yarn of polylactic acid having a diameter of 0.12 mm producing first loops and with a second heat-fusible monofilament yarn of polylactic acid having a diameter of 0.15 mm producing second loops.
[0129] The first loops and the second loops were distributed according to vertical bands. During the cutting step as described above in the application, only the second loops were melt and cut, giving rise to barbs, according to the process step shown in
[0130] The present knit therefore shows looped zones and barbed zones organised according to a pattern forming stripes similar to that shown in
[0131] KNIT 2: this knit was prepared using Knitting pattern A, with bars B2 and B3 being threaded with monofilament yarns of polyester terephthalate (PET) having a diameter of 0.08 mm. Bar B4 was threaded with a first heat-fusible monofilament yarn of polylactic acid having a diameter of 0.15 mm producing first loops and with a second heat-fusible monofilament yarn of polylactic acid having a diameter of 0.12 mm producing second loops.
[0132] The first loops and the second loops were distributed according to vertical bands. During the cutting step as described above in the application, only the second loops were melt and cut, giving rise to barbs, according to the process step shown in
[0133] The present knit therefore shows looped zones and barbed zones organised according to a pattern forming stripes similar to that shown in
[0134] KNIT 3: this knit was prepared using Knitting pattern A, with bars B2 and B3 being threaded with monofilament yarns of polyester terephthalate (PET) having a diameter of 0.09 mm. Bar B4 was threaded with a first heat-fusible monofilament yarn of polylactic acid having a diameter of 0.15 mm producing first loops and with a second heat-fusible monofilament yarn of polylactic acid having a diameter of 0.12 mm producing second loops.
[0135] The first loops and the second loops were distributed according to vertical bands. During the cutting step as described above in the application, only the second loops were melt and cut, giving rise to barbs, according to the process step shown in
[0136] The present knit therefore shows looped zones and barbed zones organised according to a pattern forming stripes similar to that shown in
[0137] KNIT 4: this knit was prepared using Knitting pattern A, with bars B2 and B3 being threaded with monofilament yarns of polyester terephthalate (PET) having a diameter of 0.09 mm. Bar B4 was threaded with a first heat-fusible monofilament yarn of polylactic acid having a diameter of 0.12 mm producing first loops and with a second heat-fusible monofilament yarn of polylactic acid having a diameter of 0.15 mm producing second loops.
[0138] The first loops and the second loops were distributed according to vertical bands. During the cutting step as described above in the application, only the second loops were melt and cut, giving rise to barbs, according to the process step shown in
[0139] The present knit therefore shows looped zones and barbed zones organised according to a pattern forming stripes similar to that shown in
[0140] KNIT 5: this knit was prepared using Knitting pattern B, with bars B2 and B3 being threaded with monofilament yarns of polyester terephthalate (PET) having a diameter of 0.09 mm. Bar B4 was threaded with a heat-fusible monofilament yarn of polylactic acid having a diameter of 0.15 mm producing loops.
[0141] During the cutting step as described above in the application, a press having a quincunx shaped relief was used, as shown in
[0142] The present knit therefore shows looped zones and barbed zones organised according to a quincunx pattern similar to that shown in
[0143] Two comparative textiles have been prepared as follows:
[0144] KNIT 6: this knit was prepared using Knitting pattern A, with bars B2 and B3 being threaded with monofilament yarns of polyester terephthalate (PET) having a diameter of 0.08 mm. Bar B4 was threaded with a heat-fusible monofilament yarn of polylactic acid having a diameter of 0.15 mm producing loops.
[0145] The cutting step was performed by contacting all the loops with a cylinder brought to a temperature causing all the loops to melt as described in WO01/81667. As a result, all the loops were cut and gave rise to barbs.
[0146] The present comparative knit is therefore provided with barbs only and is free of loops.
[0147] KNIT 7: this knit was prepared using Knitting pattern B, with bars B2 and B3 being threaded with monofilament yarns of polyester terephthalate (PET) having a diameter of 0.09 mm. Bar B4 was threaded with a heat-fusible monofilament yarn of polylactic acid having a diameter of 0.15 mm producing loops.
[0148] The cutting step was performed by contacting all the loops with a cylinder brought to a temperature causing all the loops to melt as described in WO01/81667. As a result, all the loops were cut and gave rise to barbs.
[0149] The present comparative knit is therefore provided with barbs only and is free of loops.
[0150] The “gripping-on-itself” properties of the seven knits above were evaluated according to the following protocol: knit samples of 30 cm×5 cm (warp X weft) are prepared. Each knit sample is then folded once on itself, as shown in
[0151] The maximal force (in Newton) necessary for separating the two layers is measured. This maximal force (N) corresponds to the “gripping on itself” property of the tested knit.
[0152] The results are shown in
[0153] As appears from this Figure, the textiles of the invention, namely KNITS 1 to 5, show a maximal force lower than the comparative textiles KNIT 6 and KNIT 7. This means that the textiles of the invention show less gripping forces on itself than the comparative textiles.
[0154] The deployment of the surgical textile of the invention in the surgical site is therefore improved, as the barbs of the textiles of the invention are less plugged into the background of the textile than that of the comparative textiles, and are therefore easy to detach when the surgeon wishes to unfold the textile.
[0155] In particular, thanks to the presence of the loops in the textiles of the invention, the barbs of the textiles of the invention are less entangled with one another and are less engaged in the pores of the background of the textile when the textile is folded on itself.
[0156] As a result, once at the implantation site, the unfolding of the textiles of the invention is facilitated compared to that of the comparative textiles. The exact positioning of the textiles of the invention is also improved, as the barbs are deactivated by the presence of the loops and they therefore do not impede the smooth conveying of the textiles. Thanks to the presence of the loops, the spreading of the textiles of the inventions is also made easier than for the comparative textiles. The surgeon may then push on the textile to flatten the loops and activate the barbs, so as to anchor the barbs to the biological tissue, as shown for example in
Example 2
[0157] Textiles of the invention, in particular some knits of EXAMPLE 1 above, were tested and evaluated in a simulated use environment on a pig abdominal wall model, in a view to assess the ease of use of the textiles of the invention, in particular with regards to their “gripping to surrounding tissues” when said textiles are inserted.
[0158] For each knit referred to as KNIT 3, KNIT 4 and KNIT 5 of EXAMPLE 1, three samples were prepared.
[0159] The samples were folded in half, along the weft direction of the knit, with the barbs protruding outwards.
[0160] An incision was performed on the pig wall and each folded sample was inserted through the incision to a previously created surgical site.
[0161] Each sample was deployed and slight pressure was applied on the wall to simulate the intrinsic abdominal wall pressure.
[0162] Each sample was then removed by pulling it out of the created surgical site to assess the quantity of surrounding tissues trapped by the sample.
[0163] The results showed that the presence of barbs and loops improved: [0164] the insertion of the textile: the loops prevent the barbs from being in contact with the surrounding tissues during the insertion step, [0165] the deployment of the textile, in particular: [0166] the unfolding of the textile is facilitated by the low gripping on itself of the barbs of the textiles of the invention. The deployment of the textile on the surgical site is therefore easier with the textiles of the invention than with comparative textiles showing barbs only; [0167] The exact positioning of the textile at the surgical site is facilitated: the presence of both barbs and loops allows moving the textile within the surrounding tissues more smoothly, without damaging these surrounding tissues: see for example
[0169] Moreover, thanks to the presence of both barbs and loops, the surgeon may easily attach and detach the textile to the biological tissues, several times if needed, thereby facilitating the repositioning of the textile.
[0170] The textile of the present invention allows providing a self-gripping surgical textile capable of being introduced in the body of the patient without damaging the barbs and/or the surrounding biological tissues.