METHOD FOR FORMING A BASE KNIT SUITABLE FOR MANUFACTURING HERNIA PROSTHESES AND HERNIA PROSTHESES OBTAINED THEREFROM

Abstract

The invention relates to a method for forming a prosthetic base knit (1) made of two parallel sheets of porous knits, namely a first sheet (2) of porous knit and a second sheet of porous knit, said two parallel sheets being joined together in a discrete manner by a plurality of connecting porous knits (4) spaced apart from each other. The invention further relates to a method for manufacturing H-shaped prostheses for hernia repair from said base knit thus obtained and to the prostheses obtained therefrom.

Claims

1-16. (canceled)

17. An H-shaped prosthesis suitable for hernia repair, said H-shaped prosthesis comprising an underlay layer, an onlay layer, and a connector, said underlay layer, onlay layer and connector being formed as an unitary knitted structure, wherein a length and width of each layer are independent of a length and width of said connector in a plane of said layer, the length and width of the connector in the plane of one layer being independent of the length and width of said layer in said plane.

18. The prosthesis according to claim 17, wherein the connector includes a tensile breaking strength ranges from about 80 N to about 180 N in a warp direction.

19. The prosthesis according to claim 17, wherein the connector includes a tensile breaking strength ranges from about 110 N to about 160 N in a warp direction.

20. The prosthesis according to claim 17, wherein the connector includes a tensile breaking strength ranges from about 80 N to about 180 N in a weft direction.

21. The prosthesis according to claim 17, wherein the connector includes a tensile breaking strength ranges from about 110 N to about 160 N in a weft direction.

22. The prosthesis according to claim 17, wherein the connector includes a tensile elongation under 50N ranging from about 20% to about 100% in a warp direction and ranging from about 20% to about 100% in a weft direction.

23. The prosthesis according to claim 17, wherein the connector includes a tensile elongation at break ranging from about 60% to about 200% in a warp direction and ranging from about 60% to about 200% in a weft direction.

24. The prosthesis according to claim 17, wherein the connector includes a tensile elongation at break of about 72% in a warp direction and about 112% in a weft direction.

25. The prosthesis according to claim 17, wherein the underlay layer and the onlay layer are each a bidimensional porous knit and the connector is a three-dimensional porous knit.

26. The prosthesis according to claim 17, wherein the underlay layer and the onlay layer are connected together via the connector being located at a center of the underlay layer and a center of the onlay layer.

27. The prosthesis according to claim 17, wherein the underlay layer and the onlay layer define the same shape.

28. The prosthesis according to claim 17, wherein the underlay layer and the onlay layer define different shapes.

29. The prosthesis according to claim 17, wherein the underlay layer and the onlay layer are parallel to each other.

30. The prosthesis according to claim 17, wherein the connector is perpendicular to the underlay layer and the onlay layer.

31. The prosthesis according to claim 17, wherein said unitary knitted structure includes one or more biocompatible yarns.

32. The prosthesis according to claim 31, wherein the one or more biocompatible yarns are monofilaments.

33. The prosthesis according to claim 32, wherein the monofilaments have a diameter ranging from about 0.07 mm to about 0.30 mm

34. The prosthesis according to claim 31, wherein the one or more biocompatible yarns are made of polypropylene.

35. The prosthesis according to claim 17, wherein said prosthesis is heat set.

36. An H-shaped prosthesis suitable for hernia repair, said H-shaped prosthesis comprising an underlay layer, an onlay layer, and a connector, said underlay layer, onlay layer and connector being formed as an unitary knitted structure, wherein the underlay layer, the onlay layer, or both are configured to be twisted in a direction that may differ from an initial orientation

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0187] The advantages of the method of the invention will appear more clearly from the following example and attached drawings in which:

[0188] FIG. 1 is a schematic view showing the first and second sheets of porous knits and the connecting knit of a base knit obtained according to the method of the invention,

[0189] FIG. 2 is a partial perspective view of a first embodiment of a base knit obtained according to the method of the invention,

[0190] FIG. 3 is a partial perspective view of a second embodiment of a base knit obtained according to the method of the invention,

[0191] FIG. 4 is a view showing how an adequate portion of a base knit of the invention may be isolated in a view of preparing and manufacturing a H-shaped prosthesis,

[0192] FIG. 5 is a perspective view of the adequate portion of FIG. 4 once isolated,

[0193] FIG. 6 is a perspective view of a H-shaped prosthesis of the invention obtained from the adequate portion of FIG. 5,

[0194] FIG. 7 is a top view of the H-shaped prosthesis of FIG. 6 showing how one layer of the prosthesis may be twisted with respect to the connector,

[0195] FIG. 8 is a top view of another embodiment of a H-shaped prosthesis obtained from an adequate portion as shown on FIG. 5,

[0196] FIG. 9 is a top view of another embodiment of a H-shaped prosthesis obtained from an adequate portion as shown on FIG. 5.

EXAMPLE

[0197] In the present example, a base knit 1 (see FIG. 2) is formed according to the method of the invention and a H-shaped prosthesis 10 (see FIG. 6) is manufactured from the base knit 1 obtained.

[0198] The base knit 1 is produced on a spacer Raschel knitting machine comprising a first needle-bed comprising a first guide bar B1, a second guide bar B2 and a third guide bar B3, and a second needle-bed comprising a fourth guide bar B4, a fifth guide bar B5 and a sixth guide bar B6.

[0199] All guide-bars are threaded with polypropylene monofilaments having a diameter of 0.12 mm.

[0200] In the present example, the pattern unit comprises 264 courses on each needle-bed and the threading-in unit is 156. In other embodiments, the base knit could be produced with different pattern units and threading-in units.

[0201] In the present example, all the knitting patterns are given according to the ISO 11676 standard (publication year 2014).

[0202] The knitting pattern followed by bars B1, B2, B3 and B4 is the following one: [0203] B1: (3-2-2-2/2-1-1-1/0-1-2-2)×88// [0204] B2: (2-3-3-3/3-4-4-4/5-4-3-3)×88// [0205] B3: (2-3-3-3/3-4-4-4/5-4-3-3)×36/(2-3-3-2/3-4-3-2/5-4-4-5)×3/(2-3-3-3/3-4-4-4/5-4-3-3)×49// [0206] B4: (2-3-3-2/3-4-3-2/5-4-4-5)×75/1-1-1-2/1-1-1-0/1-1-1-2/4-4-6-7/6-6-6-5/6-6-6-7/6-6-6-5/(2-2-1-0/1-1-1-2/1-1-1-0/1-1-1-2/4-4-6-7/6-6-6-5/6-5-6-7/6-6-6-5)×4// [0207] B5: (2-2-1-0/1-1-1-2/1-1-1-0/1-1-1-2/4-4-6-7/6-6-6-5/6-6-6-7/6-6-6-5)×33// [0208] B6: (5-5-6-7/6-6-6-5/6-6-6-7/6-6-6-5/3-3-1-0/1-1-1-2/1-1-1-0/1-1-1-2)×33// [0209] The threading-in of bars B1, B2, B3, B4, B5 and B6 is the following: [0210] B1: (D.)78 [0211] B2: (S.)2(D.)31(S.)4(D.)31(S.)10 [0212] B3: (S.)2.62(S.)4.62(S.)2.16 [0213] B4: 0.140(S.)8 [0214] B5: (S.)78 [0215] B6: (S.)78

[0216] wherein a dot “.” means one element empty, “D” means two yarns, “S” means a single yarn.

[0217] As a result of the above knitting pattern and threading-in unit, a base knit is obtained for which: [0218] For needles ranging from 1 to 156, and for courses ranging from 1 to 264 on each needle-bed, a first sheet of porous knit, under the form of a bidimensional porous knit, is produced on the first needle-bed by yarns of guide-bars B1 and B2, and a second sheet of porous knit, under the form of a bidimensional porous knit, is produced on the second needle-bed by yarns guide-bars B5 and B6, [0219] For needles ranging from 67 to 74 and for courses ranging from 109 to 117, a connecting porous knit is produced, joining the first sheet of porous knit to the second sheet of porous knit, under the form of a three-dimensional porous knit, by yarns of guide-bar B3, [0220] For needles ranging from 141 to 156 and for courses ranging from 1 to 264, a pillar knit is produced, joining the first sheet of porous knit to the second sheet of porous knit, under the form of a three-dimensional knit, by yarns of guide-bar B4.

[0221] As a result, for the present example, the values of x, y, w, z, r and s of the method of the invention are the following: [0222] x=109, [0223] y=117, [0224] w=67, [0225] z=74, [0226] r=141, [0227] s=156.

DETAILED DESCRIPTION OF EMBODIMENTS

[0228] With reference to FIG. 1, where Wa indicates the warp direction, is shown schematically a part of the base knit 1 with the first sheet 2 of porous knit, the second sheet 3 of porous knit, and a connecting porous knit 4. The yarns 5 of the guide bar B3 are shown crossing from the first sheet 2, produced on the first needle-bed, to the second sheet 3, produced on the second needle-bed.

[0229] In the present example, the distance between the first needle-bed and the second needle-bed is set at about 10 mm. As a consequence, the height h of the connecting knit 4 as shown on FIG. 1 is about 10 mm.

[0230] The distance between the first needle-bed and the second needle-bed may be adjusted and designed in function of the height desired for the connecting knit, and subsequently for the connector of the H-shaped prostheses obtainable from the base knit.

[0231] The pillar knits are obtained in a similar way as the connecting porous knits but they extend on the whole production length of the base knit in the warp direction.

[0232] In the base knit 1 obtained, the first sheet 2 of porous knit and the second sheet 3 of porous knit are parallel and joined together in a discrete manner by a plurality of connecting porous knits 4 spaced apart from each other.

[0233] With reference to FIG. 2 is shown a part of the base knit 1 obtained with the method described herein, where the second sheet of porous knit has been removed for sake of clarity. With reference to FIG. 2 are shown the warp direction Wa and the width direction Wi of the knitting machine.

[0234] With reference to this Figure, are shown the first sheet of porous knit 2, a plurality of connecting porous knits 4 and a plurality of pillar knits 6.

[0235] A connecting knit 4 being produced for each pattern unit and each threading-in unit, the final base knit 1 comprises as many connecting knits 4 as repetitions of the pattern unit along the length of production of the base knit 1 and of the threading-in unit along the width of the machine. On the example shown, only twelve connecting knits 4 are shown. Of course, the number of connecting knits 4 in the base knit 1 may be much higher or less. For example, if the pattern unit and the threading-in unit were followed only once and were not recurring along the production length and the width of the machine (not shown on the figures), only one connecting knit 4 would be produced, thereby allowing one H-shaped prosthesis to be formed.

[0236] In the same manner, a pillar knit 6 is produced for each threading-in unit. On the example shown, only four pillar knits 6 are shown. The total number of pillar knits 6 corresponds to the total number of threading-unit that can be repeated along the width of the machine.

[0237] The pillar knits 6 run along the warp direction of the base knit 1, substantially in a continuous way. The pillar knits 6 are intended to maintain a constant distance between the first sheet 2 of porous knit and the second sheet of porous knit on the whole area of the base knit 1 when the base knit 1 is rolled up on itself on a cylinder during storage. The pillar knits 6 are intended to preserve the correct thickness of the global base knit 1, approximately 1 cm in the present example. The pillar knits 6 help avoiding that the connecting knits 4, which are intended to be used in the manufacture of the H-shaped prostheses, be shrunk by the weight of the plurality of layers of the rolled-up base knit 1.

[0238] In embodiments not shown, the pillar knits may not extend along the warp direction in a continuous way, as long as they perform the function of maintaining a constant distance between the first sheet of porous knit and the second sheet of porous knit on the whole area of the base knit when the base knit is rolled up on itself on a cylinder during storage.

[0239] Base knits of the invention may be obtained by the method of the invention, where no pillar knits are present. With reference to FIG. 3, is shown such a base knit 100, free of any pillar knits. Such a base knit 100 may be obtained with the knitting patterns and threading-in of the present example, except for the fact that guide-bar B4 is not threaded with any yarns. The base knit 100 comprises a first sheet of porous knit 102, a second sheet of porous knit (not shown for sake of clarity) and connecting knits 104 which are identical to that of the base knit 1 of FIG. 2.

[0240] The base knit 1 is submitted to a heat-setting treatment in order to stabilize the first and second sheets (2, 3) of porous knits in the warp and weft directions and in order to stabilize the height of the connecting knits 4.

[0241] The base knit 1 is positioned in a heat-setting machine under no tension, neither in the warp direction nor in the weft direction. It is then submitted to a heat-treatment of about 140° C. The first and second sheets (2, 3) of porous knits are therefore well stabilized in the weft direction and in the warp direction and the height of the connecting knits 4 shows a shrinkage of about 50%.

[0242] Alternatively, in embodiments where the base knit is not submitted to a heat-setting treatment, the H-shaped prosthesis obtained from this base knit (see below) may be submitted to the heat-setting treatment above on its own.

[0243] With reference to FIG. 4 is shown in dotted lines an adequate portion 7 of the base knit 1 that can be selected and isolated in a view of manufacturing a H-shaped prosthesis for hernia repair. The adequate portion 7 is designed in the vicinity and around one of the connecting knits 4. The adequate portion 7 may be isolated from the base knit 1 using a pair of scissors for example. Alternatively, the adequate portion 7 may be isolated from the base knit 1 using any cutting means such as a laser, high frequency welding, etc. . . .

[0244] With reference to FIG. 5 is shown the adequate portion 7 once isolated from the base knit 1 of FIG. 4. The adequate portion 7 of the base knit comprises a portion 8 of the first sheet of porous knit, a portion 9 of the second sheet of porous knit and a connecting knit 4.

[0245] The portion 8 of the first sheet of porous knit and the portion 9 of the second sheet of porous knit are then each cut around the connecting knit 4 to the shape and dimensions desired for forming an underlay layer and an onlay layer of a H-shaped prosthesis.

[0246] With reference to FIGS. 6, 8 and 9, are shown H-shaped prostheses (10, 110, 210) thus obtained.

[0247] With reference to FIG. 6, the underlay layer 11 of the prosthesis 10 results from the cutting of the portion 8 of the first sheet of porous knit of an adequate portion 7 and has a circular shape on the example shown. The onlay layer 12 of the prosthesis 10 results from the cutting of the portion 9 of the second sheet of porous knit of an adequate portion 7 and has an oval shape on the example shown. The underlay layer 11 and the onlay layer 12 are connected together via the connector 13 (which is formed of the connecting knit 4 of the adequate portion 7). On the example shown, the connector 13 is located at the center of the underlay layer 11 but not at the center of the onlay layer 12.

[0248] With reference to FIG. 8, the underlay layer 111 of the prosthesis 110 results from the cutting of the portion 8 of the first sheet of porous knit of an adequate portion 7 and has a circular shape on the example shown. The onlay layer 112 of the prosthesis 110 results from the cutting of the portion 9 of the second sheet of porous knit of an adequate portion 7 and has an oval shape on the example shown. The underlay layer 111 and the onlay layer 112 are connected together via the connector 113, said connector 113 being, on the example shown, located at the center of the underlay layer 111 and at the center of the onlay layer 112.

[0249] With reference to FIG. 9, the underlay layer 211 of the prosthesis 210 results from the cutting of the portion 8 of the first sheet of porous knit of an adequate portion 7 and has an elliptical shape on the example shown. The onlay layer 212 of the prosthesis 210 results from the cutting of the portion 9 of the second sheet of porous knit of an adequate portion 7 and has an oval shape on the example shown. The underlay layer 211 and the onlay layer 212 are connected together via the connector 213.

[0250] As appears from FIGS. 6-9, for a H-shaped prosthesis (10, 110, 210), if the length and width of one layer, either underlay layer (11, 111, 211) or onlay layer (12, 112, 212), or of the connector (13, 113, 213), are defined as being respectively the dimension of said layer or connector in the warp direction (length) and the dimension of said layer or connector in the weft direction (width), one can see that the length and width of each layer, namely the underlay layer (11, 111, 211) and the onlay layer (12, 112, 212), in the plane of said layer, are independent of the length and width of the connector (13, 113, 213) in the plane of said layer. Similarly, the length and width of the connector (13, 113, 213) in the plane of either layer (11, 111, 211; 12, 112, 212) are independent of the length and width of said layer (11, 111, 211; 12, 112, 212) in said plane.

[0251] In other embodiments not shown, the underlay layer and the onlay layer could show different shapes, such as rectangular, square, etc. . . .

[0252] As appears clearly from the present example, since the prostheses (10, 110, 210) are produced as a single unitary structure each, there is no area of weakness at the liaisons between the underlay layer (11, 111, 211) and the connector (13, 113, 213) on one hand, and between the onlay layer (12, 112, 212) and the connector (13, 113, 213) on the other hand.

[0253] Moreover, the fact that the connector (13, 113, 213) is made from a three-dimensional porous knit allows providing a good mobility between the liaison between the underlay layer (11, 111, 211) and the connector (13, 113, 213) on one hand, and to the liaison between the connector (13, 113, 213) and the onlay layer (12, 112, 212) on the other hand.

[0254] With reference to FIG. 7, is shown the possibility of the onlay layer 12 for example to be twisted with respect to the connector 13 for a prosthesis of the invention, for example prosthesis 10 of FIG. 6. In dotted lines is shown an angularly shifted position for the onlay layer 12, with respect to its initial position. The structure of the connector 13 obtained in the H-shaped prosthesis of the invention allows the surgeon to orientate the underlay layer and/or the onlay layer in orientations slightly different from that conferred by the initial liaisons between the connector and the underlay layer and between the connector and the onlay layer.

[0255] In addition, thanks to the structure of the connector, which results from the production of a three dimensional knit forming the connecting knits, and thanks to the fact that said three dimensional knit is produced simultaneously with the first and second bidimensional knits which then form the underlay layer and the onlay layer, the liaisons between the onlay layer and the connector, and between the underlay layer and the connector, are reliable and show good mechanical properties, such as breaking strength and elongation at break.

[0256] Such mechanical properties have been measured for the connector of the H-shaped prosthesis obtained in the present example according to the following methods:

[0257] Connector tensile breaking strength and elongation in warp and weft direction: performed on a Traction testing machine (Hounsfield model H5KS-SN 0589) with the following conditions: [0258] 5 samples [0259] Width: 50 mm [0260] Length: warp direction: 30 mm between the jaws [0261] weft direction: 30 mm between the jaws [0262] Crosshead speed: 20 mm/min [0263] Pre-load: 0.5N

[0264] The connector is centered between the jaws.

[0265] The results as an average of the results of the five samples are collected in Table I below:

TABLE-US-00001 Warp Weft Breaking strength (N) 139 ± 7  143 ± 4  Elongation at 50N (%) 36 ± 2 54 ± 3 Elongation at break (%) 72 ± 5 112 ± 11

[0266] Table I: tensile breaking strength and elongation of the connector

[0267] These results show that the connector of the H-shaped prosthesis obtained according to the method of the invention is particular reliable. The surgeon may twist the underlay layer or the onlay layer with respect to the connector with no fear that the unitary structure of the prosthesis be damaged.

[0268] The following mechanical properties have been measured for the underlay layer of the H-shaped prosthesis obtained in the present example according to the following methods: [0269] Pore size: measured according to NF S94-801: 2007 “Reinforcing implants positioned via the vaginal route to treat effort urinary incontinence and/or pelvic organs prolapsus—Pre-Clinital tests and clinical tests”—§ 5.3.3 method b, with a profile projector ORAMA [0270] Tensile breaking strength (N), tensile elongation (%) and elongation under 50 N (%): are measured according to ISO 13934-1: 1999 “Determination of breaking strength and elongation”, 5 samples, width: 50 mm, length in the warp direction: 200 mm between the jaws, length in the weft direction: 120 mm between the jaws, Crosshead speed: 100 mm/min, Pre-load: 0.5 N, using a traction testing machine such as the Hounsfield model H5KS (Hounsfield, Redhill, England), [0271] Bending rigidity in warp and weft direction: 5 samples of dimensions 50×100 mm, with a slot space of 15 mm on a Handle-O-Meter machine

[0272] The results are as follows: [0273] Pore size (width mm×height mm): 1.1 mm×1.7 mm, [0274] Tensile breaking strength: 625 N in the warp direction and 278 N in the weft direction, [0275] Bending rigidity: 72 g

[0276] The underlay layer of the prosthesis of the present example therefore shows adequate pore size and mechanical properties so that it can deploy easily in the abdominal cavity and perform efficiently its wall reinforcing function.

[0277] The following mechanical properties have been measured for the onlay layer of the H-shaped prosthesis obtained in the present example according to the following methods: [0278] Pore size: same method as for the underlay above, [0279] Suture pull out strength in the warp direction and in the weft direction: measured according to NF S94-801: 2007 “Reinforcing implants positioned via the vaginal route to treat effort urinary incontinence and/or pelvic organs prolapsus—Pre-Clinical tests and clinical tests”—§ 5.2.3: a USP 2 suture yarn is passed through a pore of a 50×100 mm sample, and is tracted away using a traction testing machine such as the Hounsfield model H5KS (Hounsfield, Redhill, England) with the following conditions: 5 samples, width 50 mm, 100 mm between the jaws, crosshead speed: 100 mm/min.

[0280] The results are as follows: [0281] Pore size: 1.7 mm×3.1 mm [0282] Suture pull out strength: 43 N in the warp direction and 42 N in the weft direction.

[0283] The onlay layer of the prosthesis of the present example therefore shows adequate pore size and mechanical properties so that it shows a good flexibility, visibility and a good conformability, while being suturable. Moreover, the softness and conformability of the onlay layer helps positioning the prosthesis with regards to the abdominal wall.

[0284] The knitting method of the present example allows producing a base knit from which a plurality of H-shaped prosthesis may be obtained, in one single step, rapidly and efficiently. Since the base knit is obtained as a unitary knitted structure, there is no area of weakness between the first bidimensional porous knit and the connecting knit on one hand, and between the second bidimensional porous knit and the connecting knit on the other hand. In addition, the knitting method of the invention allows using different knitting patterns for the onlay layer and for the underlay layer: the performance characteristic of each layer can therefore be tailored to meet the clinical needs and surgeon preference, in a single manufacturing process without the need for additional manufacturing/assembly steps.

[0285] Moreover, each H-shaped prosthesis obtained from the base knit of the present example is itself obtained as a unitary structure. There is therefore no area of weakness at the liaisons between the underlay layer and the connector on one hand, and between the onlay layer and the connector on the other hand.

[0286] In addition, for each H-shaped prosthesis cut from the base knit produced according to the method of the invention, the liaisons between the underlay layer and the connector on one hand, and between the onlay layer and the connector on the other hand show a mobility and a flexibility allowing a surgeon to orientate freely the underlay layer and/or the onlay layer in directions that may differ from the initial orientations of such layers with respect to the connector, without jeopardising the efficiency and the integrity of the H-shaped prosthesis.