Low-profile meshes for robotic surgery

Abstract

With the expansion of robotic-assisted hernia repair, there is an increasing need for surgical meshes to be insertable via smaller-diameter trocars. Low-profile hernia meshes that maintain high-performance mechanical properties are obtained by calendering non-bioabsorbable or bioabsorbable textile sheets.

Description

LOW-PROFILE MESHES FOR ROBOTIC SURGERYFIELD

[0001] The present technology is generally related to hernia meshes; in particular, to low- profile hernia meshes insertable through small diameter trocars utilized in robotic (e.g., robotic- assisted) surgeries.BACKGROUND

[0002] As the availability and variety of robotic surgical procedures continue to expand, there is an increasing need for minimized surgical instruments and implants. Hernia meshes are designed to provide mechanical support to the abdominal wall. Thus, the textile component of the mesh is required to demonstrate high mechanical performance. However, with the expansion of robotic (e.g., robotic-assisted) hernia repair, the mesh must be insertable via small-diameter trocars (e.g., about 8mm). For large mesh sizes, this is particularly challenging. Accordingly, there is a need for lower-profile hernia meshes that maintain high-performance mechanical properties.SUMMARY

[0003] The techniques and apparatuses of this disclosure generally relate to low-profile hernia meshes suitable for robotic surgery.

[0004] In one aspect, a calendered textile sheet formed by calendering an uncalendered textile sheet is provided. The calendered textile sheet including compressed knit yarns having a first surface and an opposing second surface defining a compressed thickness of the calendered textile sheet, where the compressed thickness is less than an uncompressed thickness of the uncalendered textile sheet, and where the compressed knit yarns further have a first bending rigidity that is less than a second bending rigidity of uncompressed knit yarns of the uncalendered textile sheet. Further, the calendered textile sheet is provided where the compressed knit yarns comprise a polypropylene (PP) monofilament. Additionally, the calendered textile sheet is provided where a first force required to insert a first surgical mesh obtained from the calendered textile sheet through an 8mm trocar is less than a second force required to insert a second surgical mesh obtained from the uncalendered textile sheet through the 8mm trocar. The calendered textile sheet is further provided where a ball-burst strength of the calendered textile sheet is within a range of values thatis acceptable for utilizing a calendered surgical mesh obtained from the calendered textile sheet for a surgical procedure. Further still, the calendered textile sheet is provided where a uniaxial tensile strength of the calendered textile sheet is within a range of values that is acceptable for utilizing a calendered surgical mesh obtained from the calendered textile sheet for a surgical procedure. Additionally, the calendered textile sheet is provided where a suture pull-out strength of the calendered textile sheet is within a range of values that is acceptable for utilizing a calendered surgical mesh obtained from the calendered textile sheet for a surgical procedure. The calendered textile sheet is further provided where the surgical procedure is a robotic-assisted hernia repair.

[0005] In another aspect, a calendered textile sheet is provided. The calendered textile sheet including a plurality of yarn fibers forming pores therebetween, where at least a subset of the plurality of yarn fibers has been crushed and where at least one of the pores has a reduced size due to at least one yarn fiber, of the subset of yarn fibers, adjacent the at least one pore, having been crushed. Further, the calendered textile sheet is provided where the at least one yarn fiber comprises a polypropylene (PP) monofilament. Additionally, the calendered textile sheet is provided, including a first surface and an opposing second surface defining a first thickness therebetween, wherein the first thickness is at least about 10% less than a second thickness of an uncalendered textile sheet. Further still, the calendered textile sheet is provided where a first force required to insert a first surgical mesh obtained from the calendered textile sheet through an 8mm trocar is less than a second force required to insert a second surgical mesh obtained from an uncalendered textile sheet through the 8mm trocar. The calendered textile sheet is further provided where a ball-burst strength of the calendered textile sheet is within a range of values that is acceptable for utilizing a calendered surgical mesh obtained from the calendered textile sheet for a hernia procedure. Further still, the calendered textile sheet is provided where a uniaxial tensile strength of the calendered textile sheet is within a range of values that is acceptable for utilizing a calendered surgical mesh obtained from the calendered textile sheet for a hernia procedure. Additionally, the calendered textile sheet is provided where a suture pull-out strength of the calendered textile sheet is within a range of values that is acceptable for utilizing a calendered surgical mesh obtained from the calendered textile sheet for a hernia procedure. Further yet, the calendered textile sheet is provided where the hernia procedure is a robotic-assisted hernia procedure.

[0006] In yet another aspect, a method of forming a calendered textile sheet is provided. The method including delivering, from a first textile roll, an uncalendered textile sheet having a first thickness measured between a first surface of the uncalendered textile sheet and an opposing second surface of the uncalendered textile sheet. The method further including causing the uncalendered textile sheet to pass between a first cylinder and a second cylinder of a calender apparatus, where at least one of the first cylinder and the second cylinder is biased towards the other of the second cylinder and the first cylinder. Additionally, the method including applying, by at least one of the first cylinder and the second cylinder, a pressure to the uncalendered textile sheet to compress the uncalendered textile sheet as the uncalendered textile sheet passes between the first cylinder and the second cylinder, yielding a calendered textile sheet having a second thickness differing from the first thickness. Further, the method where the calendered textile sheet includes a polypropylene (PP) monofilament. The method further where the first thickness is at least about 10% less than the second thickness. Further still, the method where a first force required to insert a first surgical mesh obtained from the calendered textile sheet through an 8mm trocar is less than a second force required to insert a second surgical mesh obtained from the uncalendered textile sheet through the 8mm trocar. Additionally, the method where the 8mm trocar is configured for use in a robotic-assisted hernia procedure.

[0007] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0008] Non-limiting and non-exhaustive examples are described with reference to the following Figures.

[0009] FIG. 1 illustrates an example of a calender apparatus for implementing calendering of textiles, according to aspects of the present disclosure.

[0010] FIG. 2 is a chart illustrating results of calendering a non-bioabsorbable textile, according to aspects of the present disclosure.

[0011] FIG. 3 represents microscopical images (x20) of stitch sides of starting material A and calendered material B, according to aspects of the present disclosure.

[0012] FIG. 4 represents microscopical images (x50) of stitch sides of starting material A and calendered material B, according to aspects of the present disclosure.

[0013] FIG. 5 illustrates an overview of an example method for calendering a textile, according to aspects described herein.DETAILED DESCRIPTION

[0014] The present technology relates to low-profile hernia meshes that exhibit high- performance mechanical properties while also being insertable via small-diameter trocars, such as those used in robotic procedures. Reducing material quantity, e.g., using thinner yarn, less stiches, larger pores, etc., improves ease of trocar insertion, but impairs mechanical properties of the textile, which is inconsistent with hernia repair specifications. To overcome these issues, a high- performance textile is calendered by passing textile from a textile roll under a high-pressure cylinder, thereby crushing the fibers to reduce textile thickness without negatively impacting the mechanical properties necessary for hernia repair. In some implementations, the crushing also reduces a bending rigidity of the textile, still without negatively impacting the mechanical properties necessary for hernia repair.

[0015] The abdominal wall is composed of fat and muscles interconnected by fascias and forms the anterior side of the abdominal cavity, which houses the visceral organs encased by the peritoneum. A hernia occurs when a break in the fascias allows part of the peritoneum to protrude into or through the abdominal wall, thereby weakening it. To repair the hernia, a mesh is often implanted to replace and / or strengthen the weakened anatomical tissues. Accordingly, the textile component of the mesh must demonstrate high mechanical performance. However, with the expansion of robotic (e.g., robotic-assisted) hernia repair, the mesh must be insertable via smalldiameter trocars (e.g., about 8mm). For large mesh sizes, this is particularly challenging. Accordingly, there is a need for lower-profile hernia meshes that maintain high-performance mechanical properties.

[0016] Hernia and other surgical meshes can be knitted either from bioabsorbable yarns, non- bioabsorbable yarns, or any combination thereof. Similar to other knitted textiles, a mesh can bedescribed in terms of “warp” and “weft,” which refer to the directionality of the fibers forming the mesh. In aspects, the “warp” refers to vertical fibers and the “weft” refers to horizontal fibers. Surgical meshes are often manufactured by “warp knitting,” which involves creating a textile by sequentially forming and interconnecting courses of loops, called stitches, on a lateral array of needles. Each stitch (or loop) is formed by wrapping yarn around one of the needles and drawing it through a previously formed loop in an axial direction. Lateral movement of the threads between adjacent needles joins the loops together by a portion of yarn called a “float” or “underlap.” In aspects, the underlap side of a textile is characterized by the floats that link the individual stitches or loops together and the stitch side of a textile is characterized by the individual stitches or loops.

[0017] As described further herein with reference to the Examples below, a non-bioabsorbable textile mesh was subjected to calendering. In non-limiting examples, the non-bioabsorbable textile mesh may be comprised of polypropylene. Other suitable non-bioabsorbable materials include, without limitation: polyolefins, such as polyethylene, copolymers of polyethylene and polypropylene, and blends of polyethylene and polypropylene. Other non-bioabsorbable materials which may be utilized include polyesters such as polyethylene terephthalate (PET), polyamides, aramides, expanded polytetrafluoroethylene, polyurethane, polyvinylidene, difluoride (PVDF), polybutester, copper alloy, silver alloy, platinum, medical grade stainless steels such as 316 L medical grade stainless steel, combinations thereof, and the like. Examples of commercially available polypropylene-based textile supports which may be utilized include those sold under the brand name PARIETENE™ from Sofradim.

[0018] In further non-limiting examples, bioabsorbable textile meshes may be comprised of a composition including lactide and trimethylene carbonate (TMC). Other suitable absorbable materials include, without limitation: trimethylene, carbonate, caprolactone, dioxanone, glycolic acid, lactic acid, glycolide, lactide, homopolymers thereof, copolymers thereof, and combinations thereof. Specific absorbable materials which may be suitable include, for example, chitosan, cellulose, oxidized cellulose, combinations thereof, and the like.

[0019] Hernia and other surgical meshes can be described by their physical and mechanical properties. For example, the physical properties of a mesh can include without limitation: length, width, surface density, pore size, thickness, and bending rigidity. Mechanical properties caninclude without limitation: ball-burst strength, uniaxial tensile strength, and suture pull-out strength.

[0020] FIG. 1 illustrates an example of a calender apparatus 100 for implementing calendering of textiles, according to aspects of the present disclosure.

[0021] A “calender” or “calender apparatus” is a machine that mechanically compresses textile fibers between two cylinders, e.g., a first cylinder 102 (e.g., “pressure cylinder”) and a second cylinder 104 (e.g., “counter cylinder”). As noted above, surgical meshes are often manufactured by “warp knitting.” Accordingly, a calender apparatus 100 adapted for knitted textiles, as opposed to woven textiles, may be preferrable. In aspects, the first cylinder 102 and the second cylinder 104 may be fabricated from a metal, a metal alloy or a composite material. In some cases, the first cylinder 102 and the second cylinder 104 may be fabricated from different materials. For example, the first cylinder 102 may be fabricated from a harder material, such as a metal or metal alloy, and the second cylinder 104 may be fabricated from a softer material, such as a composite (e.g., compacted rigid cardboard). A highly cylindrical shape and very smooth surface for the cylinders, and especially a harder one (e.g., of the first cylinder 102) in embodiments in which they have different hardnesses, promotes homogenous calendering over the width and length of the textile sheet 110. By fabricating the softer cylinder (e.g., the second cylinder 104) from a softer material, damage to the harder cylinder (e.g., the first cylinder 102) may be prevented should a collision between the two cylinders occur (e.g., due to improper settings). As illustrated, the first cylinder 102 is larger than the second cylinder 104; however, in other examples, the two cylinders may be substantially the same size or the second cylinder 104 may be larger than the first cylinder 102. The calender apparatus 100 may further include or be communicatively coupled with various components, such as actuator(s) 114, heat source(s) 116, sensor(s) 118, and / or controller(s) 120.

[0022] In aspects, actuator(s) 114 may be powered by any suitable mechanism, including hydraulic, pneumatic, electric, solenoid, piezoelectric, thermal, or the like. In further aspects, actuator(s) 114 may take the form of motors, pumps, springs, gears, cams, or the like. The actuator(s) 114 may act on one or more of the calender components to calender a textile sheet 110 (e.g., a surgical mesh textile sheet). As illustrated, an uncalendered portion 110A of textile sheet 110 is unrolled from first textile roll 106, fed through tension rollers 112, and between the first cylinder 102 and the second cylinder 104 at contact area 122. A calendered portion HOB of textilesheet 110 exits contact area 122 between the first cylinder 102 and the second cylinder 104 and is rolled onto second textile roll 108. As shown, the first cylinder 102 is positioned vertically above the second cylinder 104 such that gravitational forces may act on first cylinder 102 to bias it towards second cylinder 104. In other examples, the first cylinder 102 and the second cylinder 104 may be positioned in other orientations, e.g., the first cylinder 102 may be vertically below the second cylinder 104 or the first cylinder 102 and the second cylinder 104 may be positioned horizontally side-by-side. In further examples, the first cylinder 102 and the second cylinder 104 may be oriented in any position vis-a-vis one another such that pressure may be applied to a textile sheet 110 therebetween.

[0023] In an example, one or more actuators 114 may act on the first cylinder 102 to cause rotation about a first central axis (not shown) in a direction of arrow B. In some aspects, the second cylinder 102 may rotate freely about a second central axis (not shown) in a direction of arrow C in response to the rotation of the first cylinder 102. In the illustrated orientation of calender apparatus 100, the rotational motion and a weight of the first cylinder 102 may exert a first force in a direction of arrow A that is perpendicular to a first surface of the textile sheet 110. Additionally or alternatively, the one or more actuators 114 may act on the first cylinder 102 to cause it to bias towards the second cylinder 104. In some aspects, the second cylinder 104 may be held stationary such that, as the first cylinder 102 is biased towards the second cylinder 104, the first force applied by the first cylinder 102 is augmented in a direction of arrow A. In this way, the second cylinder 104 (e.g., “counter cylinder”) may be viewed as a sort of “anvil cylinder.” Alternatively, rather than including a second cylinder 104, calendering apparatus 100 may include a flat or rounded surface to serve as an anvil against which the first cylinder 102 rotates and / or biases to calender the textile sheet 110. With respect to the various examples, a first pressure applied by the first cylinder 102 to the first surface of the textile sheet 110 is based on the first force divided by contact area 122.

[0024] Additionally or alternatively, the one or more actuators 114 may act on the second cylinder 104 to cause rotation about the second central axis (not shown) in a direction of arrow C. In this example, the second cylinder 104 may be the “pressure cylinder” or both the first cylinder 102 and the second cylinder 104 may be “pressure cylinders.” In the illustrated orientation of calender apparatus 100, the rotational motion of the second cylinder 104 may exert a second force in a direction perpendicular to a second surface of the textile sheet 110 (not shown). In furtheraspects, the second cylinder 104 may be biased towards the first cylinder 102 such that the second force is augmented (not shown). In either or both cases, a second pressure applied by the second cylinder 104 to the second surface of the textile sheet 110 is based on the second force divided by contact area 122. In aspects, the first cylinder 102 may be held in a static position vis-a-vis the second cylinder 104 or may also be rotated and / or biased towards the second cylinder 104. Accordingly, the first pressure may be applied, the second pressure may be applied, or both the first pressure and the second pressure may be applied to the textile sheet 110. Moreover, the first pressure may be the same as or different from the second pressure.

[0025] In further aspects, the first pressure applied by the first cylinder 102 and / or the second pressure applied by the second cylinder 104 may be monitored by one or more sensor(s) 118 and, at least in some cases, automatically regulated by the one or more controller(s) 120. For example, sensor(s) 118 may include pressure sensors, e.g., strain-gauge, piezoelectric, capacitive, inductive, potentiometric, and the like, for measuring the first pressure and / or the second pressure applied to the textile sheet 110. The controller(s) 120 may include, for example, pressure controllers or regulators, such as proportional, integral, derivative (PID) controllers, electronic controllers, and the like, that receive a pressure signal from sensor(s) 118 and cause the one or more actuator(s) 114 to adjust the first force applied by the first cylinder 102 and / or the second force applied by the second cylinder 104.

[0026] In some aspects, the first pressure and / or the second pressure applied to the textile sheet 110 may be automatically regulated to a first target pressure and / or a second target pressure set by an operator. For example, the first target pressure and / or the second target pressure may be set between about 60 Kg / cm2and about 300 Kg / cm2, or between about 80 Kg / cm2and about 280 Kg / cm2, or between about 100 Kg / cm2and about 260 Kg / cm2, or between about 120 Kg / cm2and about 240 Kg / cm2Kg / cm2, or any range of pressures therebetween. In aspects, the first target pressure and / or the second target pressure may be selected based on a type of material or materials forming textile sheet 110, such as non-bioabsorbable materials, bioabsorbable materials, or a combination thereof. In further aspects, the first target pressure and / or the second target pressure selected for a non-bioabsorbable textile sheet may be different than for a bioabsorbable textile sheet. For example, the first target pressure and / or the second target pressure selected for a non- bioabsorbable textile sheet may be greater than for a bioabsorbable textile sheet.

[0027] In further aspects, the first target pressure and / or the second target pressure may be selected such that a first thickness Ti of the uncalendered portion 110A is decreased to a second thickness T2 of the calendered portion HOB. In further detail, compressed knit yarns of the calendered portion HOB may have a first surface and an opposing second surface defining the second thickness T2 and uncompressed knit yarns of uncalendered portion 110A may have a first surface and an opposing second surface defining the first thickness Ti. In aspects, the second thickness T2 defined by the compressed knit yarns may be less than the first thickness Ti defined by the uncompressed knit yarns. In further aspects, the second thickness T2 may be at least about 10% less than the first thickness Ti. In still further aspects, the second thickness T2 may be at least about 20% less than the first thickness Ti, or at least about 25% less than the first thickness Ti, or at least about 30% less than the first thickness Ti, or at least about 40% less than the first thickness Ti, or at least about 50% less than the first thickness Ti. In still further aspects, the second thickness T2 may be about 5% to about 30% less than the first thickness Ti, or about 5% to about 40% less than the first thickness Ti, or about 5% to about 50% less than the first thickness Ti, or about 5% to about 60% less than the first thickness Ti.

[0028] In additional or alternative aspects, the first target pressure and / or the second target pressure may be selected such that a first bending rigidity Ri of the uncalendered portion 110A is decreased to a second bending rigidity R2 of the calendered portion HOB (see FIG. 2). In further detail, compressed knit yarns of the calendered portion HOB may have a second bending rigidity R2 and uncompressed knit yarns of uncalendered portion 110A may have a first bending rigidity Ri. In aspects, the second bending rigidity R2 of the compressed knit yams may be less than the first bending rigidity Ri of the uncompressed knit yarns. In further aspects, the second bending rigidity R2 may be at least about 5% less than the first bending rigidity Ri. In still further aspects, the second bending rigidity R2 may be at least about 10% less than the first bending rigidity Ri, or at least about 15% less than the first bending rigidity Ri, or at least about 20% less than the first bending rigidity Ri, or at least about 30% less than the first bending rigidity Ri, or at least about 40% less than the first bending rigidity Ri, or at least about 50% less than the first bending rigidity Ri, or at least about 60% less than the first bending rigidity Ri. In still further aspects, the second bending rigidity R2 may be about 5% to about 20% less than the first bending rigidity Ri, or about 5% to about 30% less than the first bending rigidity Ri, or about 5% to about 40% less than thefirst bending rigidity Ri, or about 5% to about 50% less than the first bending rigidity Ri, or about 5% to about 60% less than the first bending rigidity Ri.

[0029] In aspects, mechanical properties of the calendered portion HOB having the second thickness T2 and / or the second bending rigidity R2 may not be negatively impacted by the calendering and may be suitable for use in a surgical procedure. For example, the calendered portion HOB of textile sheet 110 may be cut, trimmed, or otherwise prepared for use as a surgical mesh, e.g., a hernia mesh. The calendered surgical mesh obtained from the calendered portion HOB may maintain physical properties and / or mechanical properties consistent with those required to repair an anatomical injury, such as a hernia. Moreover, the second thickness T2 and / or the second bending rigidity R2 of the calendered surgical mesh may decrease an amount of force (Fmax) required to insert the calendered surgical mesh through small trocars, e.g., 8mm trocars, such as those utilized in robotic-assisted laparoscopic surgical procedures. That is, by decreasing Fmax, the ease of inserting the calendered surgical mesh is increased. For example, a trocar insertion Fmax exhibited by the calendered surgical mesh may be decreased by at least about 10%, or at least about 20%, or at least about 25%, or at least about 30%, or at least about 40%, or at least about 50%. In further examples, the decrease in Fmax may be between about 5% and about 50%, or between about 10% and 40%, or between about 15% and 35%, or between about 20% and 30%, for example.

[0030] In addition to causing pressure to be applied to the textile sheet 110, the rotational movement of the first cylinder 102 and / or the second cylinder 104 may cause, at least in part, the uncalendered portion 110A of textile sheet 110 to be unrolled from the first textile roll 106. In aspects, a rotation rate of the first cylinder 102 and / or the second cylinder 104 may be monitored by the one or more sensor(s) 118 and, at least in some cases, automatically regulated by the one or more controller(s) 120. The rotation rate of the first cylinder 102 and / or the second cylinder 104 may further directly or indirectly influence an unrolling rate of the uncalendered portion 110A from the first textile roll 106. In still further aspects, the one or more actuators 114 may act on first textile roll 106 and / or second textile roll 108 to influence the unrolling rate of the uncalendered portion 110A from the first textile roll 106 and / or a rolling rate of the calendered portion HOB onto second textile roll 108. In some cases, an amount of tension applied to the textile sheet 110 along its length may be a function of the unrolling / rolling rate(s) and a length of a textile pathwayfrom the first textile roll 106 to the second textile roll 108. In aspects, a shorter textile pathway may reduce the amount of tension applied along the length of the textile sheet 110.

[0031] The calender 100 further includes tension rollers 112, which ensure that the uncalendered textile sheet 110A is taut and flat when it enters between the first cylinder 102 and the second cylinder 104. Although two tension rollers 112 are illustrated, any number of tension rollers 112 may be provided. In some examples, tension rollers 112 may rotate freely in response to the textile sheet 110 being pulled between the first cylinder 102 and the second cylinder 104. In other examples, actuators 114 may also act on tension rollers 112 to cause rotation so as to maintain the textile sheet 110 taut and flat and / or aid in unrolling the textile sheet 110 from the first textile roll 106. In some cases, an amount of tension applied to the textile sheet 110 along its length may be a function of the unrolling rate and / or the rolling rate and a length of the textile pathway from the first textile roll 106 to the second textile roll 108. In aspects, a shorter textile pathway may reduce the amount of tension applied along the length of the textile sheet 110. In aspects, as described above, the rotation rate of the first cylinder 102 and / or the second cylinder 104, the unrolling rate, and the rolling rate may be monitored by sensor(s) 118 and automatically regulated by controller(s) 120, which may enable regulation of the amount of tension applied along the length of the textile sheet 110.

[0032] In addition to pressure, heat may be applied to compress the textile sheet 110. For example, heat source 116 may transfer heat to increase a temperature of the first cylinder 102 and / or the second cylinder 104. The temperature of the first cylinder 102 and / or the second cylinder 104 may be monitored by sensors 118 and automatically regulated to a target temperature by controllers 120. In some aspects, when heat is not applied, a temperature of the first cylinder 102 and / or the second cylinder 104 may be about atmospheric temperature, e.g., about 20°C ± 2°C. When heat is applied, for example, the target temperature may be set between about 20°C and about 150°C, or between about 40°C and about 130°C, or between about 60°C and about 110°C, or any range therebetween. In aspects, the target temperature may be selected based on a type of material or materials forming textile sheet 110, such as non-bioabsorbable materials, bioabsorbable materials, or a combination thereof. For example, the target temperature selected for a non- bioabsorbable textile sheet may be different than for a bioabsorbable textile sheet. For example, the target temperature selected for a non-bioabsorbable textile sheet may be higher than for a bioabsorbable textile sheet.

[0033] As should be appreciated, FIG. 1 is provided for purposes of illustration and the described structures and features are non-limiting, i.e., structures and / or functionalities may be added or removed from the described apparatuses without departing from the disclosure herein.

[0034] EXAMPLE IMPLEMENTATIONS

[0035] Definitions:

[0036] The following terms are provided for reference:

[0037] Surface density: a mass of a textile per unit area.

[0038] Pore size: a measure of a height and a width of a void defined by the stitched lattice of a textile.

[0039] Bending rigidity: a measure of a textile’s resistance to bending under its own weight.

[0040] Ball-burst strength: a measure of a maximum localized force a textile can withstand without rupturing.

[0041] Uniaxial tensile strength: a measure of the max force a textile can withstand along a single axis without breaking. Related measurements include elongation along the single axis under 50N, 80N and max force.

[0042] Suture pull out: a measure of the amount of force required to dislodge or pull out a stitch from a textile.

[0043] Background

[0044] Starting Material A is a polypropylene (PP) monofilament mesh sheet having excellent mechanical properties; however, it is incompatible with an 8mm trocar, such as Hugo™ 8mm reusable trocars manufactured by Medtronic™ Inc. Starting Material A may be in the form of a long, uncut mesh sheet (or textile sheet), which may be cut to a suitable size for use as a surgical mesh following a calendering operation.

[0045] Materials & Methods

[0046] Calendering was applied to Starting Material A. In aspects, while the calendering methods are described with respect to a PP mesh, such methods can be performed on other suitable non-bioabsorbable meshes, bioabsorbable meshes, or compositions thereof. Prior to being testedin the same conditions, specimens were pre-conditioned for about 4 hours at standard atmosphere (temperature 20°C ± 2°C / relative humidity 65% ± 4%). The calender apparatus was configured with a target pressure of about 250 Kg / cm2to be applied by the pressure cylinder (e.g., first cylinder 102 of FIG. 1) to Starting Material A.

[0047] Results:

[0048] FIG. 2 is a chart illustrating results of calendering a non-bioabsorbable (PP) textile, according to aspects of the present disclosure. The results compare the physical properties, the mechanical performance, and ease of trocar insertion of Starting Material A and Calendered Material B.

[0049] Starting Material A

[0050] Physical properties of Starting Material A included:

[0051] (1) Surface density of 85 ± 1 gram per meter2(g / m2);

[0052] (2) Thickness of 0,73 ± 0,1 millimeters (mm);

[0053] (3) Pore size having a first pore width of 1,7 ± 0,1 (mm) and a first pore height of 2,0± 0,1 (mm); and a second pore width of 1,8 ± 0,0 (mm) and a second pore height of 1,5 ± 0,1 (mm);

[0054] (4) Total bending rigidity of 80 ± 3 (g), with a warp bending rigidity of 33 ± 1 (g) and a weft bending rigidity of 47 ± 3 (g).

[0055] Mechanical properties of Starting Material A included:

[0056] (1) In response to ball-burst testing:

[0057] Ball-burst strength recorded at maximum force (“Fmax”) of 519 ± 28 Newtons (N);

[0058] Deflection of 20,7 ± 0,7 mm; and

[0059] Tensile strength of 104 ± 2 Newtons per centimeter (N / cm).

[0060] (2) In response to uniaxial tensile testing:

[0061] Warp uniaxial tensile strength at Fmax of 369 ± 25 N;

[0062] Warp elongation at 50N of 34% ± 3%;

[0063] Warp elongation at Fmax of 82% ± 4%.

[0064] Weft uniaxial tensile strength at Fmax of 367 ± 19 N;

[0065] Weft elongation at 50N of 34% ± 1%; and

[0066] Weft elongation at Fmax of 102% ± 3%.

[0067] (3) In response to a suture pull-out testing:

[0068] Warp suture pull-out strength of 72 ± 8 N; and

[0069] Weft suture pull-out strength of 70 ± 9 N.

[0070] (4) Trocar insertion:

[0071] For trocar insertion of a 15x20 cm sample of Starting Material A into a Hugo™ 8mm reusable trocar:

[0072] An Fmax of 159 ± 20 N; and

[0073] Comments: Sample Material A exhibited rolled edges, but there was no mesh damage following trocar insertion.

[0074] Trocar insertion of a 20x20 cm sample of Starting Material A was not insertable into a Hugo™ 8mm reusable trocar due to overloading.

[0075] Calendered Material B

[0076] In response to calendering Starting Material A, the physical properties of Calendered Material B included:

[0077] (1) Surface density of 95 ± 2 (g / m2);

[0078] (2) Thickness of 0,55 ± 0,1 (mm);

[0079] (3) Pore size having a first pore width of 1,3 ± 0,1 (mm) and a first pore height of 1,8± 0,1 (mm); and a second pore width of 1,5 ± 0,1 (mm) and a second pore height of 1,5 ± 0,1 (mm);

[0080] (4) Total bending rigidity of 76 ± 5 (g), with a warp bending rigidity of 36 ± 3 (g) and a weft bending rigidity of 41 ± 3 (g).

[0081] Mechanical properties of Calendered Material B included:

[0082] (1) In response to ball-burst testing:

[0083] Ball-burst strength recorded at Fmax of 542 ± 12 (N);

[0084] Deflection of 21,2 ± 0,2 mm; and

[0085] Tensile strength of 106 ± 2 (N / cm).

[0086] (2) In response to a uniaxial tensile testing:

[0087] Warp uniaxial tensile strength at Fmax of 393 ± 7 N;

[0088] Warp elongation at 50N of 29% ± 1%;

[0089] Warp elongation at Fmax of 76% ± 2%;

[0090] Weft uniaxial tensile strength at Fmax of 349 ± 26 N;

[0091] Weft elongation at 50N of 45% ± 1%; and

[0092] Weft elongation at Fmax of 118% ± 7%.

[0093] (3) In response to a suture pull-out testing:

[0094] Warp suture pull-out strength of 56 ± 7 N; and

[0095] Weft suture pull-out strength of 74 ± 10 N.

[0096] (4) Trocar insertion:

[0097] For trocar insertion of a 15x20 cm sample of Calendered Material B into a Hugo™ 8mm reusable trocar:

[0098] An Fmax of 117 ± 8 N; and

[0099] Comments: Calendered Material B exhibited no mesh damage following trocar insertion.

[0100] Trocar insertion of a 20x20 cm sample of Calendered Material B into a Hugo™ 8mm reusable trocar was not possible due to overloading.

[0101] In the event of an inconsistency between the above descriptions of Starting Material A and Calendered Material B with FIG. 2, the data of FIG. 2 should prevail.

[0102] Calendered Mesh Visual Markers and / or Characteristics:

[0103] FIG. 3 represents microscopical images (Keyence VHX-970F) (x20, stitch side) of Starting Material 300 A and Calendered Material 300B, according to aspects of the present disclosure.

[0104] As illustrated by FIG. 3, Calendered Material 300B exhibits visual markers characteristic of calendering. For example, due to crushing by the calender apparatus, the compressed yarn fibers (e.g., compressed yarn fiber 300y') of Calendered Material 300B are flatter and wider than the uncompressed yarn fibers (e.g., uncompressed yarn fiber 300y) of Starting Material 300A. As a result of the crushed fibers, the pores (e.g., pore 3 OOP') of Calendered Material 300B are visibly smaller than the pores (e.g., pore 3 OOP) of Starting Material 300A. In further aspects, there is a greater reduction of pore size in the width direction than the height direction of pore 300P'. The compressed, interlaced fibers of inter-pore regions (e.g., circled region) of Calendered Material 300B are thicker and denser, with individual compressed yarn fibers 300y' being less distinguishable than the uncompressed yarn fibers 300y (e.g., circled region) of Starting Material 300A.

[0105] FIG. 4 represents microscopical images (Keyence VHX-970F) (x50, stitch side) of Starting Material 400A and Calendered Material 400B, according to aspects of the present disclosure.

[0106] As illustrated by FIG. 4, Calendered Material 400B exhibits visual markers characteristic of calendering. For example, due to crushing by the calender apparatus, the compressed yarn fibers (e.g., compressed yarn fiber 400y') of Calendered Material 400B are flatter and wider than the uncompressed yarn fibers (e.g., uncompressed yarn fiber 400y) of Starting Material 400A. As a result of the compressed fibers 400y', the pores (e.g., pore 400P') of Calendered Material 400B are visibly smaller than the pores (e.g., pore 400P) of Starting Material 400A. That is, calendered pore height (h1) and calendered pore width (w1) of pore 400P' are shorter than the starting pore height (h) and starting pore width (w) of pore 400P. In further aspects, there is a greater reduction of pore size in the width direction (w1) than the height direction (h1) of pore 400P' due to the tension applied on the textile. The compressed, interlaced fibers 400y' of interpore regions (e.g., circled regions) of Calendered Material 400B are thicker and denser, with individual compressed yarn fibers 400y' being less distinguishable and having smaller gaps 400Gbetween compressed yarn fibers 400y' than gaps 400G between the uncompressed, interlaced fibers 400y of Starting Material 400A.

[0107] Result Discussion:

[0108] A summary of the results is provided below, including the impact of calendering on the physical properties, mechanical performance, and trocar insertion force of the samples tested.

[0109] Physical Properties:

[0110] Calendering had a measurable impact on the physical properties of the polypropylene (PP) mesh, as exhibited by Calendering Material B, including:

[0111] (1) A loss of textile thickness of about 24% to about 27% was observed. Monofilament and stitch crushing were visible in microscopical images (Keyence VHX-970F) (see FIGS. 3-4).

[0112] (2) Pore size was impacted primarily in the weft direction (pore width) with a measurable decrease.

[0113] (3) Surface density increased by more than about 10% after calendering. In some aspects, textile width may not be maintained during calendering. In this case, tension in length (e.g., rolling tension and crushing tension) may result in textile contraction in the weft direction (e.g., textile width), resulting in smaller pore width, higher pore height and greater surface density.

[0114] (4) Bending rigidity exhibited a reduction of about 0% to about 16%, which was balanced by an increase in textile surface density of about 8% to about 16%.

[0115] Mechanical Properties:

[0116] Calendering had a minimal impact on the textile mechanical performances, as described below:

[0117] (1) Ball-burst strength increased slightly, which may be explained by the greater surface density.

[0118] (2) Tensile strength increased slightly in the warp direction, which may be explained by the loss in textile width. The loss of textile width is also visible in the elongation result with a slight decrease in warp direction and an increase in weft direction.

[0119] (3) A measurable decrease in suture pull-out strength in the warp direction was observed. In aspects, local shearing between stitches during calendering may have resulted in a localized damage zone on the monofilaments.

[0120] Trocar insertion:

[0121] Calendering resulted in a substantial decrease in trocar insertion Fmax, as exhibited by the Calendered Material B. In particular, a decrease in Fmax of about 10% to about 39% for insertion of a 15x20 cm calendered mesh into a Hugo™ 8mm reusable trocar was observed. In some aspects, the decrease in Fmax may be at least about 10%, or at least about 20%, or at least about 25%, or at least about 30%, or at least about 40%, or at least about 50%. In further aspects, the decrease in Fmax may be between about 5% and about 50%, or between about 10% and 40%, or between about 15% and 35%, or between about 20% and 30%, for example. Insertion of a 20x20 cm calendered mesh was not possible.

[0122] Visible Characteristics:

[0123] As illustrated by FIGS. 3 and 4, Calendered Material B exhibits visual markers characteristic of calendering. For example, due to crushing by the calender apparatus, the yarn fibers of Calendered Material B are flatter and wider than the yarn fibers of Starting Material A. As a result of the crushed fibers, the pores of Calendered Material B are smaller than the pores of Starting Material A. That is, the calendered pore height and calendered pore width of Calendered Material B are less than the starting pore height and starting pore width of Starting Material A. In further aspects, there is a greater reduction of pore size in the width direction than the height direction of Calendered Material B. The crushed, interlaced fibers of inter-pore regions of Calendered Material B are thicker and denser, as described above, with individual yarn fibers being less distinguishable and having smaller gaps between yarn fibers than those of Starting Material A.

[0124] Conclusion:

[0125] Calendering resulted in a substantial improvement in the ability for mesh to be inserted through a small trocar, such as those used in robotic (or robotic-assisted) procedures (e.g., 8mm trocars), while mechanical performance was impacted minimally, if at all. That is, a surgical mesh obtained by cutting or trimming Calendered Material B exhibited mechanical performance withina range of values that is acceptable for use in a surgical procedure, such as a surgical procedure to repair a hernia, while the surgical mesh was also better-suited for insertion into small-trocars (e.g., 8mm trocars).

[0126] EXAMPLE METHODS

[0127] FIG. 5 illustrates an overview of an example method 500 for calendering a textile sheet, according to aspects described herein.

[0128] At operation 502, a textile sheet (e.g., a sheet of surgical mesh) is delivered from a first textile roll, such as the first textile roll 106 of FIG. 1. As described further below, the textile sheet may have a first thickness. In some aspects, delivering the textile sheet includes unrolling it from the first textile roll and passing it over one or more tension rollers, such as tension rollers 112 in FIG. 1. The tension rollers may be configured and operated to prevent folding of the textile sheet to keep it flat and taut as it is delivered from the first textile roll. In further aspects, as will be described further below, delivering the textile sheet from the first textile roll may be based on an unrolling rate, which may be directly or indirectly based on a rotation rate of a first cylinder and / or a second cylinder of a calender apparatus.

[0129] At operation 504, the textile sheet is caused to pass between a first cylinder (e.g., first cylinder 102 of FIG. 1) and a second cylinder (e.g., second cylinder 104) of a calender apparatus (e.g., calender apparatus 100). The “calender” or “calender apparatus” is a machine that mechanically compresses textile fibers between two cylinders. In aspects, as the textile sheet passes between the first cylinder and the second cylinder, at least the first cylinder may contact the textile sheet over a contact area. While the first cylinder and the second cylinder represent the calender, or calender apparatus, in primary embodiments, in some implementations, other portions of the systems described herein, including but not limited to any portions shown in and described in connection with FIG. 1 , can be considered a part of the calender, or calender apparatus, such as the one or more tension rollers 112, the first textile roll 106 (e.g., source roll), the second textile roll 108, the actuators 114, the heat source 116, the sensors 118, the controllers 120, and any combination thereof.

[0130] At operation 506, a rotation rate of at least the first cylinder is configured. As detailed above, one or more actuators (e.g., actuators 114) may cause the first cylinder to rotate about a central axis. Moreover, the rotation rate of the first cylinder may be monitored by one or moresensors (e.g., sensors 118) and automatically regulated and / or operated by one or more controllers (e.g., controllers 120). The rotation rate of the first cylinder may further directly or indirectly influence an unrolling rate of the textile sheet from the first textile roll. As described above, regulation of the unrolling rate may prevent folding of the textile sheet and may maintain the textile sheet taut as it passes between the first cylinder and the second cylinder. In some aspects, an amount of tension applied to the textile sheet along its length may be a function of a length of a textile pathway from the first textile roll to the second textile roll and the unrolling rate and / or the rolling rate (described further below). Particularly for macroporous knitted surgical meshes, applying an undue tension along the length of the textile sheet may cause deformation and damage. Accordingly, by regulating the rotation rate of the first cylinder and / or the unrolling rate of the first textile roll, the amount of tension applied along the length of the textile sheet may be regulated, at least in part, to minimize deformation. Moreover, a shorter textile pathway may also reduce the amount of tension along the length of the textile sheet to minimize deformation.

[0131] At operation 508, a pressure is applied to the textile sheet by at least the first, pressure, cylinder of the calender against the second, counter, cylinder. In various embodiments, the first cylinder comprises a metal or metal alloy with an associated weight. As described above, one or more actuators may act on the first cylinder to cause rotation about its central axis. In the orientation of calender components illustrated by FIG. 1 , the rotational motion and the weight of the first cylinder may exert a force that is perpendicular to the textile sheet. In aspects, a pressure applied by the first cylinder to the textile sheet is based on the force divided by the contact area of the first cylinder with the textile sheet.

[0132] In further aspects, as described above, the pressure applied by the first cylinder may be monitored by one or more sensors and automatically regulated by one or more controllers. In some aspects, a suitable pressure is determined for calendering a particular mesh composition, e.g., non- bioabsorbable, bioabsorbable, or any combination thereof; for a particular purpose or function, e.g., hernia repair, breast implantation, urogynecologic repair, or the like; or for a particular type of surgical procedure, e.g., laparoscopic procedures, robotic procedures, or the like. In some cases, a pressure delivered to a non-bioabsorbable textile sheet may be greater than for a bioabsorbable textile sheet. For example, the pressure applied may be between about 60 Kg / cm2and about 300 Kg / cm2, or between about 80 Kg / cm2and about 280 Kg / cm2, or between about 100 Kg / cm2andabout 260 Kg / cm2, or between about 120 Kg / cm2and about 240 Kg / cm2, or any range of pressures therebetween.

[0133] In addition to pressure, heat may be applied to compress the textile sheet, for example, by transferring heat from a heat source to increase a temperature of the first cylinder and / or the second cylinder. In aspects, when heat is not applied, a temperature of the first cylinder and / or the second cylinder may be about atmospheric temperature, e.g., about 20°C ± 2°C. Alternatively, when heat is applied, the amount of heat applied to the textile can depend, for instance, on whether the textile comprises a non-bioabsorbable material, a bioabsorbable or resorbable material, or a combination thereof. In aspects, the amount of heat applied to a non-bioabsorbable textile sheet may be higher than for a bioabsorbable textile sheet. In aspects, the amount of heat applied to the textile sheet may be regulated based on regulating a temperature of the first cylinder and / or the second temperature. As described above, the temperature of the first cylinder and / or the second cylinder may be monitored by one or more sensors (e.g., sensors 118 of FIG. 1) and automatically regulated by one or more controllers (e.g., controllers 120 of FIG. 1). For example, the temperature of the first cylinder and / or the second cylinder may be regulated to between about 20°C and about 150°C, or between about 40°C and about 130°C, or between about 60°C and about 110°C, or any range of temperatures therebetween.

[0134] At operation 510, based on the pressure applied by at least the first cylinder, the textile sheet is compressed between the first cylinder and the second cylinder of the calender apparatus. Following compression, the compressed (calendered) textile sheet (e.g., calendered portion 110A of textile sheet 110 in FIG. 1) has a second thickness less than the first thickness of the starting (uncalendered) textile sheet (e.g., uncalendered portion HOB of textile sheet 110 in FIG. 1). For example, the second thickness may be at least about 10% less than the first thickness, or at least about 20% less than the first thickness, or at least about 25% less than the first thickness, or at least about 30% less than the first thickness, or at least about 40% less than the first thickness, or at least about 50% less than the first thickness. In further examples, the second thickness of the calendered textile sheet may be about 5% to about 30% less than the first thickness, or about 5% to about 40% less than the first thickness, or about 5% to about 50% less than the first thickness, or about 5% to about 60% less than the first thickness.

[0135] Further following compression, a second bending rigidity of the compressed (calendered) textile sheet (e.g., calendered portion 110A of textile sheet 110 in FIG. 1) is less than a first bending rigidity of the starting (uncalendered) textile sheet (e.g., uncalendered portion HOB of textile sheet 110 in FIG. 1). For example, the second bending rigidity may be at least about 5% less than the first bending rigidity, or at least about 10% less than the first bending rigidity, or at least about 15% less than the first bending rigidity, or at least about 20% less than the first bending rigidity, or at least about 30% less than the first bending rigidity, or at least about 40% less than the first bending rigidity, or at least about 50% less than the first bending rigidity, or at least about 60% less than the first bending rigidity. In further examples, the second bending rigidity of the calendered textile sheet may be about 5% to about 20% less than the first bending rigidity, or about 5% to about 30% less than the first bending rigidity, or about 5% to about 40% less than the first bending rigidity, or about 5% to about 50% less than the first bending rigidity, or about 5% to about 60% less than the first bending rigidity.

[0136] At operation 512, the compressed (calendered) textile sheet (e.g., calendered portion 110A of textile sheet 110 in FIG. 1 ) is fed from between the first cylinder and the second cylinder onto a second textile roll (e.g., second textile roll 108 of FIG. 1). The second textile roll maintains the calendered textile sheet (e.g., calendered surgical mesh sheet) until it is cut or otherwise made selectively from portions of the calendered textile sheet into calendered surgical mesh for use in surgical procedures, for example, robotic-assisted hernia repair. Based at least on the reduction in thickness and / or bending rigidity of the calendered textile sheet, the resulting calendered surgical mesh may be more easily inserted into the small trocars (e.g., 8mm trocars) utilized in robotic- assisted laparoscopic surgeries. That is, an amount of force (Fmax) required to insert the calendered surgical mesh through small trocars may be decreased. For example, a trocar insertion Fmax exhibited by the calendered surgical mesh may be decreased by at least about 10%, or at least about 20%, or at least about 25%, or at least about 30%, or at least about 40%, or at least about 50%. In further examples, the decrease in Fmax may be between about 5% and about 50%, or between about 10% and 40%, or between about 15% and 35%, or between about 20% and 30%.

[0137] At operation 514, a rate of rolling the compressed sheet of mesh onto the second roll may be configured. In some aspects, the unrolling rate from the first roll and the rolling rate onto the second roll may be coordinated and / or may be the same or similar. As described above, actuators may act on the second textile roll to cause the calendered textile sheet to feed onto thesecond textile roll. Further, as described above, the rolling rate may be monitored by one or more sensors (e.g., sensors 118) and automatically regulated and / or operated by one or more controllers (e.g., controllers 120). Regulation of the rolling rate may prevent folding of the calendered textile sheet and may maintain the textile sheet taut as it is fed from between the first cylinder and the second cylinder onto the second textile roll. Moreover, as detailed above, an amount of tension applied to the textile sheet along its length may be a function of a length of a textile pathway from the first textile roll to the second textile roll and the unrolling rate (described above) and / or the rolling rate. Particularly for macroporous knitted surgical meshes, applying an undue tension along the length of the textile sheet may cause deformation and damage. Accordingly, by regulating the rolling rate of the second textile roll, the amount of tension applied along the length of the textile sheet may be regulated, at least in part, to minimize deformation.

[0138] As should be appreciated, operations 502-514 are described for purposes of illustrating the present methods and systems and are not intended to limit the disclosure to a particular set or sequence of steps. For example, operations may be performed in a different order and more or fewer operations may be performed without departing from the scope of the present disclosure.

[0139] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0140] In one or more examples, the described techniques may be implemented using hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non- transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to storedesired program code in the form of instructions or data structures and that can be accessed by a computer).

[0141] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

Claims

CLAIMS1. A calendered textile sheet (HOB, 300B, 400B) formed by calendering an uncalendered textile sheet (110A, 300 A, 400A), comprising: compressed knit yarns (300y', 400y') having a first surface and an opposing second surface defining a compressed thickness (T2) of the calendered textile sheet (HOB, 300B, 400B), wherein the compressed thickness (T2) is less than an uncompressed thickness (Ti) of the uncalendered textile sheet (110 A, 300A, 400A); and wherein the compressed knit yarns (300y', 400y') further have a first bending rigidity that is less than a second bending rigidity of uncompressed knit yarns (300y, 400y) of the uncalendered textile sheet (110 A, 300A, 400A).

2. The calendered textile sheet of claim 1, wherein the compressed knit yarns comprise polypropylene (PP) monofilaments.

3. The calendered textile sheet of claim 1 or 2, wherein a first force required to insert a first surgical mesh obtained from the calendered textile sheet through an 8mm trocar is less than a second force required to insert a second surgical mesh obtained from the uncalendered textile sheet through the 8mm trocar.

4. The calendered textile sheet of one of claims 1 to 3, wherein a ball-burst strength of the calendered textile sheet is within a range of values that is acceptable for utilizing a calendered surgical mesh obtained from the calendered textile sheet for a surgical procedure.

5. The calendered textile sheet of one claims 1 to 4, wherein a uniaxial tensile strength of the calendered textile sheet is within a range of values that is acceptable for utilizing a calendered surgical mesh obtained from the calendered textile sheet for a surgical procedure.

6. The calendered textile sheet of one claims 1 to 5, wherein a suture pull-out strength of the calendered textile sheet is within a range of values that is acceptable for utilizing a calendered surgical mesh obtained from the calendered textile sheet for a surgical procedure.

257. A calendered textile sheet (HOB, 3OOB, 400B), comprising: a plurality of yarn fibers (300y, 400y) forming a plurality of pores (3 OOP, 400P) therebetween, wherein at least a subset of yarn fibers (300y', 400y') of the plurality of yarn fibers (300y, 400y) has been crushed, and wherein at least one pore (300P1, 400P') of the plurality of pores (300P, 400P) has a reduced size due to at least one yarn fiber (300y', 400y'), of the subset of yarn fibers (300y', 400y'), adjacent the at least one pore (300P1, 400P'), having been crushed.

8. The calendered textile sheet of claim 7, wherein the at least one yarn fiber comprises a polypropylene (PP) monofilament.

9. The calendered textile sheet of one of claims 7 or 8, further comprising: a first surface and an opposing second surface defining a first thickness therebetween, wherein the first thickness is at least about 10% less than a second thickness of an uncalendered textile sheet.

10. The calendered textile sheet of one of claims 7 or 8, wherein a first force required to insert a first surgical mesh obtained from the calendered textile sheet through an 8mm trocar is less than a second force required to insert a second surgical mesh obtained from an uncalendered textile sheet through the 8mm trocar.

11. The calendered textile sheet of one of claims 7 or 8, wherein at least one of a ball-burst strength, a uniaxial tensile strength, or a suture pull-out strength of the calendered textile sheet is within a range of values that is acceptable for utilizing a calendered surgical mesh obtained from the calendered textile sheet for a hernia procedure.

12. The calendered textile sheet of claim 11 , wherein the hernia procedure is a robotic-assisted hernia procedure.

13. A method of forming a calendered textile sheet, comprising:delivering (502), from a first textile roll (106), an uncalendered textile sheet (110A, 300A, 400A) having a first thickness (Ti) measured between a first surface of the uncalendered textile sheet (110A, 300A, 400A) and an opposing second surface of the uncalendered textile sheet (110 A, 300A, 400A); causing (504) the uncalendered textile sheet (110A, 300 A, 400 A) to pass between a first cylinder (102) and a second cylinder (104) of a calender apparatus (100), wherein at least one of the first cylinder (102) and the second cylinder (104) is biased towards the other of the second cylinder (104) and the first cylinder (102); and applying (508), by at least one of the first cylinder (102) and the second cylinder (104), a pressure to the uncalendered textile sheet (110A, 300A, 400A) to compress the uncalendered textile sheet (110A, 300A, 400A) as the uncalendered textile sheet (110A, 300A, 400A) passes between the first cylinder (102) and the second cylinder (104), yielding a calendered textile sheet (HOB, 300B, 400B) having a second thickness (T2) differing from the first thickness (Ti).

14. The method of claim 13, wherein the calendered textile sheet comprises polypropylene (PP) monofilaments.

15. The method of one of claims 13 or 14, wherein the first thickness is at least about 10% less than the second thickness.

Images