Method for forming a mesh having a barbed suture attached thereto and the mesh thus obtained

Abstract

The invention relates to a method for forming a mesh having a barbed suture attached thereto, comprising the following steps: a) producing a knitted structure on a knitting machine comprising at least one needle-bed with three guide bars, on a length corresponding to N stitches ranging from 1 to N, wherein i) a first knit portion is produced along stitches ranging from 1 to x, where 1<x<N, ii) a second knit portion is produced for stitches ranging from (x+1) to N, in which the knitting pattern produces at least one weft stitched chain stitch, b) cutting the second knit portion on both sides of the weft stitched chain stitch and along an edge separating the second knit portion from the first knit portion, while maintaining the weft stitched chain stitch attached to the first knit portion. The invention also relates to the mesh obtained by this method.

Claims

1. A prosthesis for hernia repair comprising a mesh including a first knit portion including at least first and second biocompatible yarns, and at least one barbed suture attached to the first knit portion, the barbed suture including an elongate body and a plurality of first yarn cuts extending substantially radially out from the elongate body forming barbs, the elongate body having at least one weft stitched chain stitch made from at least one of the second biocompatible yarn or a third biocompatible yarn, and the first yarn cuts made from the first biocompatible yarns stitched to the at least one second or third biocompatible yarns of the elongate body.

2. The prosthesis of claim 1, wherein the first yarn cuts forming the barbs extend from the weft stitch of the at least one weft stitched chain stitch of the elongate body.

3. The prosthesis of claim 1, wherein the elongate body includes a plurality of weft stitched chain stitches.

4. The prosthesis of claim 1, wherein the at least one weft stitched chain stitch is made from both the second and third biocompatible yarns.

5. The prosthesis of claim 1, wherein the first biocompatible yarn forms the weft stitch of the weft stitched chain stitch, and the second and third biocompatible yarns form the chain stitch of the weft stitched chain stitch.

6. The prosthesis of claim 1, wherein the elongate body of the barbed suture is formed of the second biocompatible yarns only.

7. The prosthesis of claim 1, wherein the first knit portion further includes the third biocompatible yarn.

8. The prosthesis of claim 1, wherein the mesh and the barbed suture are a knitted structure having a determined length in a warp direction corresponding to a total number of N stitches ranging from 1 to N in the warp direction, N being an integer above 7, wherein the total number of N stitches includes a number of stitches for the first knit portion ranging from 1 to x, where 1<x<N and a number of stitches for the elongate body ranging from (x+1) to N.

9. The prosthesis of claim 1, wherein the at least one barbed suture has a final length from about 0% to about 90% greater than an initial knit length of the at least one barbed suture.

10. The prosthesis of claim 1, wherein the at least one barbed suture has a final length of about 40% greater than an initial knit length of the at least one barbed suture.

11. The prosthesis of claim 1, wherein the at least one barbed suture has a final length about 40% greater than an initial knit length of the at least one barbed suture and includes an angle of about 45° between the first yarn cuts and the elongate body.

12. The prosthesis of claim 1, wherein the at least one barbed suture includes one or more medico-surgically useful substances.

13. The prosthesis of claim 1, wherein the at least one barbed suture additionally includes a needle on a free end of the elongate body.

14. The prosthesis of claim 1, wherein the first knit portion includes at least one weft stitched chain stitch.

15. The prosthesis of claim 1, wherein the at least one barbed suture includes active portions including the barbs and passive portions free of the barbs with varying lengths therebetween along the elongate body.

16. The prosthesis of claim 1, wherein the at least one barbed suture is stretched, twisted, heat-set, or combinations thereof.

17. The prosthesis of claim 1, wherein the first knit portion is an openworked knit capable to favoring cellular growth.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

(1) The advantages of the method of the invention will appear more clearly from the following examples and attached drawings in which:

(2) FIG. 1 is a schematic top view showing an embodiment of the knitted structure obtained in step a) of the method of the invention in the case where one needle-bed is used,

(3) FIG. 2 is a schematic view showing an embodiment of a knitting pattern suitable for the knitting process of step a.sup.o) ii) of the method of the invention in the case where one needle-bed is used such as in FIG. 1,

(4) FIG. 3 is a schematic view showing the cutting step of the method of the invention for the knitted structure of FIG. 1,

(5) FIG. 4 is a schematic top view showing a mesh having a barbed suture attached thereto obtained after performing step b.sup.o) of the method of the invention on the knitted structure of FIG. 1,

(6) FIG. 5 is a partial front view of an attached barbed suture obtained by the method of the invention showing the angle formed between the barbs and the elongate body of the suture,

(7) FIG. 6 is a partial schematic view of an attached barbed suture obtained after step b.sup.o) of the method of the invention having active and passive portions along its length,

(8) FIG. 7 is a schematic side view showing the knitted structure obtained in step a) of the method of the invention in the case where two needle-beds are used,

(9) FIG. 8 is a schematic top view of the knitted structure of FIG. 7,

(10) FIG. 9 is a schematic top view of the knitted structure of FIG. 7 after cutting step b.sup.o),

(11) FIG. 10 is a schematic side view showing optional step c.sup.o),

(12) FIG. 11 is a side view of the prosthetic mesh of the invention obtained from the knitted structure of FIG. 7 after step d.sup.o),

(13) FIG. 12 is a top view of the prosthetic mesh of the invention obtained from the knitted structure of FIG. 7 after step d.sup.o).

DETAILED DESCRIPTION OF THE INVENTION

Examples

Example 1

(14) In the present example, a prosthetic mesh 1 (see FIG. 4) having an attached barbed suture 10 attached thereto is formed according to the method of the invention, using on needle-bed only.

(15) In a first step, step a.sup.o), a knitted structure 2 (see FIG. 1) is produced on a Raschel machine comprising one needle-bed comprising a first guide bar B1, a second guide bar B2 and a third guide bar B3. The knitted structure is produced on a determined length along the warp direction corresponding to a total number N of 70 stitches, with x=30.

(16) In other embodiments, the knitted structure could be produced on other lengths corresponding to other number of stitches.

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

(18) With reference to FIG. 1, is shown schematically a piece of the knitted structure 2, with the first knit portion 13 and the second knit portion 12, and the edge 14 separating the first knit portion 13 from the second knit portion 12. The knitted structure 2 is produced as described below.

(19) In a step a)i), the first knit portion 13 capable of favoring cellular growth is produced for stitches ranging from 1 to 30.

(20) The knitting pattern followed by bars B1, B2 and B3 is the following one: Bar B1: (5.4/3.2/0.1)×10// Bar B2: (5.4/3.2/0.1)×10// Bar B3: (0.1/2.3/5.4)×10//

(21) In a step a)ii), the second knit portion 12 is produced for stitches ranging from 31 to 70.

(22) The knitting pattern followed by bars B1, B2 and B3 is the following one: Bar B1: (0.0/2.3/5.5/3.2)×10// Bar B2: (2.3/2.3/3.2/3.2)×10// Bar B3: (2.3/2.3/3.2/3.2)×10//

(23) In both steps a)i) and aii), B1 is threaded 1 full, 3 empty, B2 is threaded 1 full, 3 empty and B3 is threaded 1 full, 3 empty, along the whole width of the machine.

(24) Such a pattern results in a distance between a weft stitched chain stitch and the two adjacent chain stitches of about 3.5 mm.

(25) The yarns threaded in guide bar B1 (first yarns) are polypropylene monofilaments having a diameter of 0.20 mm.

(26) The yarns threaded in guide bar B2 (second yarns) are multifilament yarns of ultra high molecular weight polyethylene, such as those marketed by the company DSM under the tradename “Dyneema Purity®”. These multifilaments have a tensile strength of 35 cN/dTex.

(27) The yarns threaded in guide bar B3 (third yarns) are polypropylene monofilaments having a diameter of 0.30 mm.

(28) With reference to FIG. 2 showing the knitting pattern of step a)ii) above in accordance with a representation well known for one skilled in the art, are shown the warp direction Wa, the weft direction We, the first yarns “a” (threaded in guide bar B1) shown as a thick line, the second yarns “b” (threaded in guide bar B2) shown as a dotted line, and the third yarns “c” (threaded in guide bar B3) shown as a thin line. The knitting pattern produces a plurality of chain stitches 3 (with second and third yarns (b, c) coming from guide bars B2 and B3) and a partial weft 4 (with first yarns “a” coming from guide bar B1). The first yarns “a” complete weft stitches 5 with some of the chain stitches 3, herein after called weft stitched chain stitches 6. Actually, as appears from FIG. 2, the knitting pattern produces one weft stitched chain stitch 6 out of two chain stitches 3 present in the second knit portion 12. In the present example, it happens that the weft stitched chain stitches 6 correspond to all the chain stitches 3 that are made with the second yarns “b”. In other embodiments not shown, the weft stitched chain stitches 6 could correspond to the chain stitches 3 that are made with the third yarns “c”, or could correspond to some of the chain stitches made with the second yarns “b” or with the third yarns “c”. In the present example, the distance between two adjacent weft stitched chain stitches 6 is due to the threading-in of the second guide bar B2, which is 1 full, 3 empty. Such a threading-in may result in a distance between the weft stitched chain stitches 6 of about 3.5 cm.

(29) With reference to FIG. 3, in a second step, step b.sup.o), the second knit portion 12 thus produced is cut along the warp direction on both sides of the weft stitched chain stitches 6 and along the edge 14 separating the second knit portion 12 from the first knit portion 13 along cutting lines 11, so as to remove the second knit portion 12 from the knitted structure 2 while maintaining the weft stitched chain stitch 6 attached to the first knit portion 13. The cutting step may be performed for example with a pair of scissors.

(30) For sake of clarity, the figures show the cutting step for one weft stitched chain stitch 6 only. Anyway, the cutting step may be repeated for each weft stitched chain stitch 6 present on the width of the knitted structure 2 corresponding to the desired width of the final mesh 1 to be obtained.

(31) FIG. 4 shows the mesh 1 having an attached barbed suture 10 obtained in the present example with the method of the invention, with the first knit portion 13 forming the mesh and the attached weft stitched chain stitch 6, in which the chain stitch yarn (second yarn “b” with reference to FIG. 2) of the weft stitched chain stitch 6 forms the elongate body 9 of the barbed suture 10 and the monofilament cuts 7 coming from first yarns “a” and extending from the weft stitches 5 of the weft stitched chain stitch 6 form the barbs 8 of the barbed suture 10.

(32) As shown on this Figure, the attached weft stitched chain stitch 6 which is also the elongate body 9 of the attached barbed suture 10 extends along a longitudinal axis A1, and the monofilament cuts 7, which are also the barbs 8, each extend along a longitudinal axis A2. On

(33) FIG. 4, the angle α between axis A1 and axis A2 is substantially about 90°.

(34) As appears from the cutting step shown on FIG. 3, the length of the monofilament cuts 7, and therefore of the barbs 8, depend both on the initial distance between the weft stitched chain stitch 6 and adjacent chain stitches 3, and on the location of the cutting lines 11.

(35) Although FIG. 4 shows the mesh 1 with only one attached barbed suture 10, a plurality of attached barbed sutures 10 could be obtained depending on the number of weft stitched chain stitches 6 cut along the width of the knitted structure 2 corresponding to the desired width of the final mesh 1 to be obtained.

(36) With reference to FIG. 6 is shown schematically a portion of an attached barbed suture 10 obtained according to the method of the present example in the case where the first guide bar B1 was fed intermittently with the first yarns. During the time periods for which the guide bar B1 was not fed with the first yarns, no weft stitches were produced on the weft stitched chain stitch 6, thereby resulting in portions of the weft stitched chain stitch 6 free of barbs, namely passive portions 15. An attached barbed suture 10 having alternating active portions 16 (when guide bar B1 was fed with first yarns) and passive portions 15 is therefore obtained. As shown on this Figure, the respective distances (L1, L2) between two adjacent active portions 16 may vary, as such distances are dependent on the time period during which the guide bar B1 was not fed.

(37) With reference to FIG. 5 is shown a larger view of a portion of the attached barbed suture 10 of FIG. 4 after a stretching treatment in which the attached barbed suture was stretched at 90%. As appears from this Figure, after the stretching treatment, the angle α between axis A1 and axis A2, in other words between the yarn “b” forming the elongate body 9 of the barbed suture 10 and the monofilament cuts 7, also barbs 8, has been modified and is now about 33°.

(38) The attached barbed suture 10 of FIG. 5 is then submitted to a heat-setting treatment in order to fix the configuration of the barbs 8 with respect to the elongate body 9 of the suture 10.

(39) In embodiments not shown, the knitting pattern used in step a)ii) above may result in all chain stitches being also weft stitched chain stitches, when the first yarns produce weft stitches with all chain stitches produced by the second and the third guide bars. In other embodiments, the knitting pattern may produce only one weft stitched chain stitch out of three, four, five, etc. . . . chain stitches present in the second knit portion, which may result in variations of the distance between two adjacent weft stitched chain stitches. Alternatively, this distance may vary due to different threading-in of the guide bars.

(40) The mesh 1 with the barbed suture 10 attached thereto may be particularly useful in hernia repair. The mesh may play its function of abdominal wall repair while the one or more barbed sutures 10 attached thereto may be used by the surgeon in order to fix the mesh to the abdominal wall. The surgeon does not have to look for sutures at the time he needs to fix the mesh to the biological tissue. Moreover, because of the barbed nature of the suture(s) attached to the mesh, the surgeon needs not perform surgical knots. The barbs of the attached barbed suture(s) perform the anchoring function of the suture into the biological tissue very efficiently.

Example 2

(41) In the present example, a prosthetic mesh 28 having a plurality of barbed sutures (10; 10′) attached thereto (see FIG. 12) is formed according to the method of the invention using two needle-beds. The knitting machine used may be a Raschel knitting machine comprising a double needle-bed. The description of the method used in the present example is made with reference to FIGS. 7-12.

(42) The Raschel knitting machine comprises a first needle-bed comprising three guide bars B1, B2 and B3 and a second needle-bed comprising three guide bars B4, B5 and B6. In the present example, the same references that are used for the production and steps performed in relation to the first needle-bed will be maintained for the production and steps performed in relation to the first needle-bed, but with a “prime” indicated after the reference digit.

(43) In the present example, all the guide bars (B1, B2, B3, B4, B5, B6) are threaded 1 full, 3 empty along the whole width of the machine and all the knitting patterns are given according to the ISO 11676 standard (publication year 2014).

(44) In the present example:

(45) first guide bar B1 is threaded with first yarns and sixth guide bar B6 is threaded with sixth yarns, the first and sixth yarns being monofilaments of polypropylene having a diameter of about 0.20 mm,

(46) second guide bar B2 is threaded with second yarns, and fifth guide bar B5 is threaded with fifth yarns, the second and fifth yarns being multifilaments of high tenacity polyester having a thickness of 165 dTex,

(47) third guide bar B3 is threaded with third yarns and fourth guide bar B4 is threaded with fourth yarns, the third and fourth yarns being monofilaments of polypropylene having a diameter of about 0.30 mm.

(48) In a first step a), a knitted structure 27 (see FIG. 7) is produced on a length in the warp direction Wa corresponding to a number N of 70 stitches, with x=30 and y=6. The warp direction Wa is indicated on FIG. 7. Although this warp direction is not repeated for FIGS. 8-10 for sake of clarity, it is identical for these Figures as in FIG. 7.

(49) 1.sup.o) During step a)0): for stitches ranging from 1 to 6, a connecting portion 20 is produced under the form of a three-dimensional openworked knit 21 capable of favoring cellular growth, according to the following knitting pattern: B1: (5.4.3.3/3.2.1.1/0.1.3.3)×2// B2: (5.4.3.3/3.2.1.1/0.1.3.3)×2// B3: 0.1.0.1/2.3.2.3/5.4.2.2/0.1.2.2/2.3.4.4/5.4.2.2// B4: 0.1.0.1/2.3.2.3/4.4.5.4/2.2.0.1/2.2.2.3/4.4.5.4// B5: (3.3.5.4/3.3.3.2/1.1.0.1)×2// B6: (3.3.5.4/3.3.3.2/1.1.0.1)×2//

(50) The above knitting pattern allows producing a knit that has a first face produced on the first needle-bed by the first, second and third yarns from the first, second and third guide bars (B1, B2, B3), and a second face, produced on the second needle-bed by the fourth, fifth and sixth yarns from the fourth, fifth and sixth guide bars (B4, B5, B6), the first and second faces being linked together by some of the third and/or fourth, yarns crossing from the first needle-bed to the second needle-bed and vice-versa, thereby forming linking yarns.)

(51) 2.sup.o) During step a)i): for stitches ranging from 7 to 30: a first knit portion 22 is produced. During this step and the subsequent step, independent knits are produced on each of the needle bed in parallel.

(52) On the first needle-bed, a first bidimensional openworked knit 23 capable of favoring cellular growth is produced according to the following knitting pattern:

(53) B1: (5.4.3.3/3.2.1.1/0.1.3.3)×8// B2: (5.4.3.3/3.2.1.1/0.1.3.3)×8// B3: (0.1.2.2/2.3.4.4/5.4.2.2)×8//

(54) On the second needle-bed, a second bidimensional openworked knit 23′ capable of favoring cellular growth is produced according to the following knitting pattern: B4: (2.2.0.1/2.2.2.3/4.4.5.4)×8// B5: (3.3.5.4/3.3.3.2/1.1.0.1)×8// B6: (3.3.5.4/3.3.3.2/1.1.0.1)×8//

(55) The first and second bidimensional openworked knits being independent from each other. They each constitute a bidimensional knit suitable for use as a reinforcement member for the repair of hernia in the abdominal wall.

(56) 3.sup.o) During step a)ii): for stitches ranging from 31 to 70: a second knit portion 24 is produced.

(57) On the first needle-bed, a first needle-bed second knit portion 25 is produced according to the following knitting pattern: B1: (0.0.0.0/2.3.4.4/5.5.5.5/3.2.1.1)×10// B2: (2.3.2.2/2.3.3.3/3.2.3.3/3.2.2.2)×10// B3: (2.3.2.2/2.3.3.3/3.2.3.3/3.2.2.2)×10//

(58) In a similar way as described in Example 1 for the second knit portion 12, in the present example, the knitting pattern followed by the second and third guide bars (B2, B3) produces chain stitches and the knitting pattern followed by the first guide bar B1 produces a partial weft in which said first yarns complete weft stitches with a plurality, four in the example shown in the Figures, of said chain stitches, thereby producing a plurality of weft stitched chain stitches 6, four in the example shown.

(59) On the second needle-bed, a second needle-bed second knit portion 25′ is produced according to the following knitting pattern: B4: (2.2.2.3/2.2.2.3/3.3.3.2/3.3.3.2)×10// B5: (2.2.2.3/2.2.2.3/3.3.3.2/3.3.3.2)×10// B6: 1.1.0.0/0.0.2.3/4.4.5.5/5.5.3.2)×10//

(60) Similarly to what takes place for the first-needle bed, the knitting pattern followed by the fourth and fifth guide bars (B4, B5) produces chain stitches and the knitting pattern followed by the sixth guide bar B6 produces a partial weft in which the sixth yarns complete weft stitches with a plurality, four as shown on the Figures, of said chain stitches, thereby producing a plurality of weft stitched chain stitches, for example four weft stitched chain stitches 6′.

(61) The knitted structure 27 produced in the step a) above is shown on FIGS. 7 and 8 which are schematic side view and bottom view of the knitted structure.

(62) In a step b.sup.o), with reference to FIGS. 9-12:

(63) the first needle-bed second knit portion 25 is cut along the warp direction on both sides of each of the four weft stitched chain stitches 6 obtained by first, second and third guide bars (B1, B2, B3) and along an edge 26 separating the first needle-bed second knit portion 25 from the first bidimensional openworked knit 23, so as to remove the first needle-bed second knit portion 25 from the knitted structure 27 while maintaining the four weft stitched chain stitches 6 attached to the first bidimensional openworked knit 23,

(64) the second needle-bed second knit portion 25′ is cut along the warp direction on both sides of each of the four weft stitched chain stitches 6′ obtained by third, fourth and fifth guide bars (B4, B5, B6) and along an edge 26′ separating the second needle-bed second knit portion 25′ from the second bidimensional openworked knit 23′, so as to remove the second needle-bed second knit portion 25′ from the knitted structure 27 while maintaining the four weft stitched chain stitches 6′ attached to the second bidimensional openworked knit 23′.

(65) The cutting step is performed in the same manner as described in Example 1.

(66) In a step c.sup.o), with reference to FIG. 10, the linking yarns from the three-dimensional openworked knit 21 obtained in step a)0) are cut along stitches ranging from 2 to 6. As a result, the connecting knit portion 20 comprises a cut part 20a and a bridge part 20b, said bridge part 20b connecting the part of the knitted structure 27 obtained on the first needle-bed to the part of the knitted structure 27 obtained on the second needle-bed.

(67) This step may be optional, for example in the case where the connecting knit portion 20 extends already on a length corresponding to 2 stitches only from the start. The purpose of this step c.sup.o) is to reduce the height of the connecting knit portion in the final configuration of the mesh as shown in FIG. 11, in order to avoid generating an extra thickness in the middle of the mesh 28.

(68) If the number of stitches in the warp direction along which the connecting knit portion extends from the start is low enough for not producing any extra thickness in the final configuration of the mesh, than the present step c.sup.o) is unnecessary.

(69) In a step d.sup.o), the knitted structure 27 is opened so as to spread in a single plane the part of the knitted structure obtained from the first needle-bed and the part of the knitted structure obtained from the second needle-bed as shown on FIGS. 11 and 12.

(70) With reference to FIGS. 11 and 12, the first bidimensional openworked knit 23, the connecting knit portion 20, cut according to step c.sup.o), and the second bidimensional openworked knit 23′ form altogether the mesh 28: this mesh 28 is made of knits capable of favoring cellular growth and is therefore particularly indicated for repair of the abdominal wall for example. The second yarns forming part of the weft stitched chain stitches 6 obtained by first, second and third guide bars (B1, B2, B3) form the elongate body 9 of first barbed sutures 10 attached to the first bidimensional openworked knit 23, the monofilament cuts 7 of first yarns extending from the weft stitches of the weft stitched chain stitches 6 form the barbs 8 of the first barbed sutures 10; the fifth yarns forming part of the weft stitched chain stitches 6′ obtained by fourth, fifth and sixth guide bars (B4, B5, B6) form the elongate body 9′ of second barbed sutures 10′ attached to the second bidimensional openworked knit 23′, the monofilament cuts 7′ of sixth yarns extending from the weft stitches of the weft stitched chain stitches 6′ form the barbs 8′ of the second barbed sutures 10′.

(71) In the present example, the elongate bodies 9 of the first barbed sutures 10 are formed of second yarns only and the elongate bodies 9′ of the second barbed sutures 10′ are formed of fifth yarns only.

(72) In other embodiments not shown, the elongate bodies 9 of the first barbed sutures 10 may be formed of third yarns only or of a combination of second and third yarns, and the elongate bodies 9′ of the second barbed sutures 10′ may be formed of fourth yarns only or of a combination of fourth and fifth yarns.

(73) The mesh 28 having barbed sutures (10, 10′) attached thereto as obtained in the present example may be particularly useful in hernia repair. The mesh 28 may play its function of abdominal wall repair while the barbed sutures (10, 10′) attached thereto may be used by the surgeon in order to fix the mesh 28 to the abdominal wall. The surgeon does not have to look for sutures at the time he needs to fix the mesh to the biological tissue. Moreover, because of the barbed nature of the suture(s) (10, 10′) attached to the mesh 28, the surgeon needs not perform surgical knots. As appears from FIGS. 11 and 12, the barbs (8, 8′) of the attached barbed suture(s) (10, 10′) are naturally oriented in opposite direction, thereby performing efficiently their anchoring function of the suture (10; 10′) and of the mesh 28 into the biological tissue.

(74) In addition, the attached barbed sutures (10; 10′) of the mesh 28 may be further submitted to a treatment, such as a stretching treatment, a twisting treatment, a heat-setting treatment and/or a combination of these treatments, so as to provide them with an optimized configuration in function of the intended use of the mesh and sutures, in order to ensure an optimized fixation of the mesh in the biological tissues.

(75) The method of the invention allows preparing prosthetic meshes having one or more barbed suture(s) attached thereto in a very simple way, and in only one single knitting process. The method further allows adapting very easily and in a cost effective manner the nature and structure of the attached barbed suture(s), such as frequency per cm, configuration, spacing, length and surface area of the barbs, depending upon the tissue in which the barbed suture(s) are to be used. With the method of the invention, it is possible to obtain meshes having barbed suture(s) attached thereto, with barbed suture(s) in which the barbs may be arranged in any suitable pattern, for example, helical, linear, or randomly spaced.