Implantable prosthesis

Abstract

An implantable prosthesis for repairing defects in a muscle or tissue wall. The prosthesis includes a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that autonomously assumes a three-dimensional curved shape configured to conform to the muscle or tissue wall. The body may be formed of a mesh fabric using a knit structure. The body may be configured with one or more mechanical properties having defined characteristics that, individually or in any combination, can improve the ability to handle the prosthesis in a surgical robotic environment while meeting performance and physical characteristics for soft tissue repair and reconstruction. One or more visual indicia may be provided to facilitate positioning and / or placement of the prosthesis in the muscle or tissue wall.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to implantable prostheses, and more particularly to implantable prostheses for use in soft tissue and muscle wall repair. [Background technology]

[0002] Muscle or tissue wall defects, such as hernias, are commonly repaired with implantable prostheses configured to cover and / or fill the defect. Often, flat sheets of implantable, non-absorbable, flexible mesh material, such as BARD MESH, are used for bowel wall repair of hernias and abdominal wall evisceration. However, surgeons sometimes have difficulty placing the mesh between the parietal peritoneum and the abdominopelvic wall. Additionally, the mesh can fold or wrinkle and can be difficult to maintain in place.

[0003] Applicant has previously developed an implantable prosthesis for repairing defects in muscle or tissue walls to alleviate some of these concerns. Some versions of the prosthesis, disclosed in U.S. Patent Nos. 5,954,767, 6,723,133, and 6,740,122, are made of an implantable, non-absorbable, flexible material that is configured to autonomously assume a curved shape adapted to match the anatomical shape of the wall. The prosthesis includes a body composed of a first portion having a substantially spherical shape and a second portion joined to the first portion. The second portion may have a substantially conical or spherical shape.

[0004] Prostheses have proven useful and established in performing repairs of muscle or tissue walls in the inguino-femoral region: they are not stressed when deformed and therefore do not tend to dislocate when implanted.

[0005] Nevertheless, the applicant has discovered that aspects of the prosthesis can be improved. Summary of the Invention [Problem to be solved by the invention]

[0006] It is an object of the present disclosure to provide an improved prosthesis for repairing muscle or tissue wall defects. [Means for solving the problem]

[0007] In one exemplary embodiment, an implantable prosthesis for repairing a defect in a muscle or tissue wall includes a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that autonomously assumes a curved shape configured to conform to the muscle or tissue wall. The body has a ball burst strength of 45 lbs to 52 lbs.

[0008] In one exemplary embodiment, an implantable prosthesis for repairing a defect in a muscle or tissue wall includes a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that autonomously assumes a curved shape configured to conform to the muscle or tissue wall. The body has a tensile strength of 12.6 lbs to 17.1 lbs in the longitudinal direction and 31.4 lbs to 44.9 lbs in the transverse direction.

[0009] In one exemplary embodiment, an implantable prosthesis for repairing a defect in a muscle or tissue wall includes a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that autonomously assumes a curved shape configured to conform to the muscle or tissue wall. The body has a tear resistance of 7.8 lbs to 12.3 lbs longitudinally and 7.7 lbs to 12.9 lbs transversely.

[0010] In one exemplary embodiment, an implantable prosthesis for repairing a defect in a muscle or tissue wall includes a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that autonomously assumes a curved shape configured to conform to the muscle or tissue wall. The body has a breaking elongation of 100.3% to 133.7% in the longitudinal direction and 52.6% to 66.4% in the transverse direction.

[0011] In one exemplary embodiment, an implantable prosthesis for repairing a defect in a muscle or tissue wall includes a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that autonomously assumes a curved shape configured to conform to the muscle or tissue wall. The body has a ball burst strength of 45 lbs to 52 lbs, a tensile strength of 12.6 lbs to 17.1 lbs in the longitudinal direction and 31.4 lbs to 44.9 lbs in the transverse direction, a tear resistance of 7.8 lbs to 12.3 lbs in the longitudinal direction and 7.7 lbs to 12.9 lbs in the transverse direction, and a breaking elongation of 100.3% to 133.7% in the longitudinal direction and 52.6% to 66.4% in the transverse direction.

[0012] In one exemplary embodiment, an implantable prosthesis for repairing an inguinal hernia includes a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that autonomously assumes a curved shape configured to conform to the wall of the groin. The body is surrounded by an outer peripheral edge and includes an apex relative to the outer peripheral edge. The body includes a recess configured to receive the external iliac vessels, the recess extending in a direction from the apex toward the outer peripheral edge. The body includes a visual indicia extending along at least a portion of the recess between the apex and the outer peripheral edge.

[0013] In one exemplary embodiment, an implantable prosthesis for repairing an inguinal hernia includes a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that autonomously assumes a curved shape configured to conform to the wall of the groin. The body is surrounded by an outer peripheral edge and includes an apex relative to the outer peripheral edge. The body includes a rounded ridge extending from the outer peripheral edge to at least the apex. The rounded ridge is configured to be positioned along the axis of the inguinal ligament. The body includes a visual indicia extending along at least a portion of the rounded ridge between the outer peripheral edge and the apex.

[0014] According to one embodiment, the body may be formed of a double-bar warp knit mesh manufactured according to a first bar pattern chain of 4 / 2 4 / 6 4 / 2 6 / 8 6 / 4 6 / 8 and a second bar pattern chain of 6 / 8 2 / 0 6 / 8 4 / 2 8 / 10 4 / 2. The mesh is knitted from a first monofilament having a first diameter and a second monofilament having a second diameter larger than the first diameter. The first monofilament is knitted according to the first bar pattern chain, and the second monofilament is knitted according to the second bar pattern chain.

[0015] According to one embodiment, the body may be formed of a knit mesh including a plurality of generally polygonal primary pores defined by knit strands of first filaments. A pair of respective second filaments extends across each primary pore to define a plurality of secondary pores within each primary pore. Each of the pair of second filaments extends substantially parallel to one another. The first filaments have a first diameter, and the second filaments have a second diameter greater than the first diameter.

[0016] Various embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 1 is a plan view of a prosthesis according to an exemplary embodiment of the present disclosure. [Figure 2] 2 is a plan view of the prosthesis of FIG. 1 showing positioning markings according to an exemplary embodiment of the present disclosure. [Figure 3] FIG. 3 is a perspective view of the prosthesis of FIGS. 1 and 2. [Figure 4] FIG. 10 is a plan view of a prosthesis according to another exemplary embodiment of the present disclosure. [Figure 5] 5 is a cross-sectional view of the prosthesis taken along section line 5-5 of FIG. 4. [Figure 6] 6 is a cross-sectional view of the prosthesis taken along section line 6-6 of FIG. 4. [Figure 7]5 is a plan view of the prosthesis of FIG. 4 showing positioning markings according to an exemplary embodiment of the present disclosure. [Figure 8] FIG. 1 is a close-up view of a double-bar warp knit mesh fabric according to an exemplary embodiment of the present disclosure. [Figure 9A] 9 shows a chain wrapping pattern for the mesh fabric of FIG. 8. [Figure 9B] 9 shows a chain wrapping pattern for the mesh fabric of FIG. 8. [Figure 10] FIG. 1 is a schematic diagram for determining the area of ​​a primary cell. DETAILED DESCRIPTION OF THE INVENTION

[0018] Detailed Description The present disclosure relates to an implantable prosthesis for repairing defects in a muscle or tissue wall. The prosthesis includes a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that autonomously assumes a three-dimensional curved shape configured to conform to the muscle or tissue wall. In this manner, the prosthesis can be collapsed into a contracted configuration, such as an elongated cylinder, for delivery to a surgical site. Upon delivery, the prosthesis can autonomously return to its preformed three-dimensional contoured shape.

[0019] The body can be formed of a material that is relatively flexible, thin, and lightweight and meets the performance and physical properties for soft tissue repair and reconstruction procedures. The prosthesis can be used to reinforce and close soft tissue defects, with particular application in chest wall reconstruction and / or hernia repair, such as inguinal hernia repair.

[0020] An embodiment of the prosthesis includes a body formed of a mesh fabric. The mesh fabric may employ a knitted structure that provides relatively large openings or pores to ensure good visibility of the underlying anatomical structures without sacrificing the mechanical properties of the mesh. The porosity of the fabric allows for tissue infiltration to incorporate the prosthesis. The knitted fabric is sufficiently strong and structured to eliminate or minimize the possibility of pullout of fixation fasteners, such as sutures, staples, and tacks. The flexible repair fabric can allow for easy size reduction for insertion into a surgical subject. In this manner, the flexible fabric can be folded into an elongated shape, such as a roll, and supported and advanced through a narrow laparoscopic cannula for use in laparoscopic surgery.

[0021] Aspects of the prosthesis relate to improving its handling, for example, for use in a surgical robotic environment. The body can be configured with one or more mechanical properties having defined properties that, individually or in any combination, can improve the ability of the prosthesis to be handled in a surgical robotic environment while meeting performance and physical characteristics for soft tissue repair and reconstruction.

[0022] Embodiments of the prosthesis may include one or more visual indicia to facilitate positioning and / or placement of the prosthesis in a muscle or tissue wall. The indicia may include alphabetic symbols, numeric symbols, alphanumeric symbols, and / or other symbols, individually or in any combination, to identify one or more portions of the prosthesis and / or the orientation of the prosthesis relative to the muscle or tissue wall of the defect site.

[0023] In one exemplary embodiment, shown in Figures 1-3, an implantable prosthesis 20 includes a body 22 of biocompatible prosthetic material having a preformed, three-dimensional contoured configuration with a curved shape configured to match the anatomical shape of a defective muscle or tissue wall. As shown in Figures 5-6, the body can include an inner surface 24 formed with a generally concave shape and an outer surface 26 formed with a generally convex shape. The body configuration facilitates placement and minimizes slippage of the prosthesis when positioned on the wall.

[0024] The body may have multiple molded portions formed together or otherwise joined to create a desired configuration. In one embodiment, the body may include a first portion 28, a second portion 30, a third portion 32, and a fourth portion 34. The body may be surrounded by an outer peripheral edge 36 including a first margin 38 and a second margin 40 joined to each other at first and second ends 42, 44 of the body. The first margin 38 may include a first segment 46 extending along the outer edge of the first portion 28 and defining the outer edge of the first portion 28, and a second segment 48 extending along the outer edge of the second portion 30 and defining the outer edge of the second portion 30. Similarly, the second margin 40 may include a first segment 50 extending along the outer edge of the third portion 32 and defining the outer edge of the third portion 32, and a second segment 52 extending along the outer edge of the fourth portion 34 and defining the outer edge of the fourth portion 34.

[0025] The body may include a first curved surface formed by first portion 28 and second portion 30, and a second curved surface formed by third portion 32 and fourth portion 34. The first and second surfaces may be joined to one another along a rounded ridge 54 extending from first end 42 to second end 44 of the body. In one embodiment for repairing an inguinal hernia, the rounded ridge is configured to be positioned along the axis of the inguinal ligament.

[0026] The body may include an apex 56 that defines the maximum height of the prosthesis relative to the outer peripheral edge. The rounded ridge may include a first segment 58 extending from the first end 42 to the apex 56 and a second segment 60 extending from the second end 44 to the apex.

[0027] In one exemplary embodiment, the body may include a recess 62 configured to receive an adjacent blood vessel or organ when the prosthesis is implanted in a muscle or tissue wall. As shown, the recess 62 may be located along the second curved surface between the third portion 32 and the fourth portion 34 of the body. The recess may extend across the second curved surface in a direction from the apex 56 toward the second margin 40. In one embodiment, the recess may be configured to receive an iliac vessel when the prosthesis is used for inguinal hernia repair. However, it should be understood that a recess is not required in all applications of the prosthesis. Furthermore, if provided, the recess may be configured to accommodate any blood vessel, organ, muscle, or tissue that may be located adjacent to the prosthesis when implanted in a defect site.

[0028] In one exemplary embodiment, first portion 28 may have a spherical shape. As shown, first portion is bounded by first segment 46 of first margin 38, second portion 30, first segment 58 of rounded ridge 54, and a portion of second segment 60 of rounded ridge.

[0029] In one exemplary embodiment, second portion 30 may have a conical shape with a base 64 extending from first margin 38 to rounded ridge 54 and a tip located at body second end 44. The second portion is joined to the first portion along its base and is bounded by first margin second segment 48 and a portion of rounded ridge second segment 60.

[0030] In one exemplary embodiment, third portion 32 may be joined to first portion 28 along a first segment 58 of a rounded ridge between first end 42 and apex 56. The third portion may be joined to fourth portion 34 along a recess 62, bounded by a first segment 50 of second margin 40.

[0031] In one exemplary embodiment, the fourth portion 34 may be joined to the first portion 28 and the second portion 30 along a second segment 60 of the rounded ridge 54 between the second end 44 and the apex 56. The fourth portion may be joined to the third portion 32 along a recess 62, bounded by the second segment 50 of the second margin 40 and the recess 62.

[0032] In one exemplary embodiment, the first curved surface formed by the first portion 28 and the second portion 30 may have a first slope from the rounded ridge 54 to the first margin 38, and the second curved surface formed by the third portion 32 and the fourth portion 34 may have a second slope from the rounded ridge 54 to the second margin 40. In one embodiment, the second slope may be greater than the first slope.

[0033] In one exemplary embodiment, the first and second margins 38, 40 of the body may be smooth and stiffer than the remainder of the body to facilitate prosthesis collapse. In this manner, the margins may be formed to facilitate the prosthesis's spontaneous return to its preformed three-dimensional shape after collapse. The margins may be formed by welding material over a width of approximately 3 mm. However, it should be understood that the width of the margins may be selected to vary their stiffness or rigidity.

[0034] In some applications, it may be desirable to use a prosthesis that is configured to significantly reduce the occurrence of wrinkles or folds between the first and second portions so that the first and second portions do not partially obscure each other during or after implantation, thereby ensuring that the overall size of the prosthesis is sufficient to adequately cover the desired portion of the wall. Such a configuration may be particularly suitable for prostheses having a relatively large size.

[0035] In one exemplary embodiment shown in Figures 4-6, the first portion 28 may have a spherical shape. As shown, the first portion is bounded by a first segment 46 of the first margin 38, the second portion 30, and a first segment 58 of the rounded ridge 54. The first segment 46 of the first margin 38 may have a circular shape. The boundaries 58, 66 of the first portion 28 with the second portion 30 and the third portion 32 intersect at the apex 56 of the prosthesis.

[0036] In one exemplary embodiment, second portion 30 joins first portion 28 along border 66 and is bounded by first margin second segment 48 and rounded ridge second segment 60. First margin second segment 48 may have a circular shape.

[0037] In one exemplary embodiment, along and perpendicular to interface 66 between the first and second portions, first portion 28 has a first radius of curvature and second portion 30 has a second radius of curvature that is substantially equal to the first radius of curvature. Such a configuration significantly reduces the occurrence of wrinkles or folds between the first and second portions such that the first and second portions do not partially obscure each other during or after implantation, thereby ensuring that the overall size of the prosthesis is sufficient to adequately cover the desired portion of the wall.

[0038] In one exemplary embodiment, the third portion 32 joins the first portion 28 along a first segment 58 of the rounded ridge 54 between the first end 42 and the apex 56. The third portion may be joined to the fourth portion 34 along a recess 62, bounded by the first segment 50 of the second margin 40. As shown, the first segment of the second margin may be curved.

[0039] In one exemplary embodiment, the fourth portion 34 joins the second portion 30 along a second segment 60 of the rounded ridge 54 between the second end 44 and the apex 56. The fourth portion may be joined to the third portion 32 along a recess 62, bounded by the second segment 52 of the second margin 40 and the recess 62. As shown, the second segment of the second margin may be curved.

[0040] As shown in Figures 4-6, the first margin 38 and second margin 40 form a generally D-shaped peripheral edge of the prosthesis, which may be welded or fused to allow the body to recover its contoured shape after being deformed during implantation.

[0041] In one embodiment, each of the third portion 32 and the fourth portion 34 may have a substantially spherical shape to improve conformance to a particular anatomical shape. In one exemplary embodiment, the radius of curvature of the third portion 32 and the fourth portion 34 is smaller than the radius of curvature of the first portion 28 to form a surface of the third portion 32 and the fourth portion 34 that has a steeper slope compared to the first portion.

[0042] The prosthesis may be configured to have any shape and size suitable for a particular application. In one embodiment, the height H of the prosthesis from the plane defined by the peripheral edge 36 and the apex 56 is approximately 21 mm. The first portion 28 has a substantially spherical shape with a radius of curvature of approximately 120 mm, particularly where it joins with the adjacent second portion 30, which has a substantially identical radius of curvature of approximately 120 mm. The third portion 32 and fourth portion 34 each have a substantially spherical shape with a radius of curvature of 35 mm. The total surface area of ​​the prosthesis is approximately 44,780 mm. 2 and the second portion 10 is approximately 12,735 mm 2 has a surface area of

[0043] The exemplary embodiment is particularly suited for inguinal hernia repair, however, it should be understood that this configuration is exemplary and that the prosthesis may be configured to have other shapes and sizes suitable for a particular application.

[0044] As noted above, it may be desirable to provide a prosthesis having a configuration particularly suited for inguinal hernia repair. The prosthesis 20 may include a body 22 of prosthetic material preformed into a three-dimensional configuration that facilitates placement and minimizes slippage of the prosthesis when positioned over the wall of a groin defect. The body may include multiple molded sections that together create the desired configuration. When used to repair an inguinal hernia, specific orientations between the several sections of the body may be configured to align with the obliqueness of the external iliac vessels and / or along the axis of the inguinal ligament to facilitate desired placement of the prosthesis.

[0045] In one embodiment shown in FIG. 4, the first portion 28 and the third portion 32 can be configured with an angle A at the apex 56 between the first segment 58 of the rounded ridge 54 and the recess 62, thereby positioning the recess substantially opposite the external iliac vessels when implanted for inguinal hernia repair. In one embodiment, the angle A can be greater than 100°. In one embodiment, the angle A can range from approximately 101° to 120°. However, as will be appreciated by those skilled in the art, it should be understood that the prosthesis can utilize other suitable angles A to accommodate particular anatomical features.

[0046] The specific angular orientation between the first segment 58 of the rounded ridge 54 and the recess 62 between the third and fourth portions 32, 34 is adapted to the slope of the external iliac vessels to facilitate prosthesis placement and minimize prosthesis slippage when positioned on the wall. The angular orientation and recess also provide some flexibility to match adjacent contours.

[0047] In some applications, it may be desirable to provide one or more visual indicia to assist in the placement and / or orientation of the prosthesis at the defect site.

[0048] 2, 3, and 7, the prosthesis may include a first marking 70 extending along the rounded ridge 54 between the second end 44 and the apex 56. As shown, the first marking 70 may extend through the apex, across the first portion 28, and toward a location along the first segment 46 of the first margin 38 offset from the first end 42. In an inguinal hernia repair, the first marking 70 may be positioned to facilitate placement and orientation of the prosthesis along the inguinal ligament.

[0049] One or more additional symbols may be provided to assist in the placement and orientation of the prosthesis. As shown, an arrow symbol 72 may be provided along with the letter "M" 74 to visually identify the medial portion of the prosthesis, which is to be placed at the medial end of the inguinal canal. It should be understood that any one or more suitable symbols may be used as needed to assist in the placement and orientation of the prosthesis.

[0050] In one exemplary embodiment shown in Figures 2, 3, and 7, second markings 76 may be provided to aid in identification of the recess 62 of the prosthesis. The second markings 76 may extend along the recess between the second margin 40 and the apex 56. As shown, the markings may extend from the apex between the third portion 32 and the fourth portion 34 of the body. In an inguinal hernia repair, the second markings 76 may be placed to facilitate placement and orientation of the recess adjacent the iliac vessels.

[0051] In one exemplary embodiment, the first indicia 70 and the second indicia 76 may extend in a linear direction across the body 22. However, it should be understood that the indicia may have any suitable configuration, as would be understood by one of ordinary skill in the art.

[0052] In one embodiment, the indicia may be formed of a monofilament that may be sewn or knitted into the body. The indicia may have a contrasting color to the body to aid in easy identification of the indicia. It should be understood that the visual indicia may be formed on the body using any suitable technique, such as printing or stenciling, as would be apparent to one skilled in the art.

[0053] The body 22 of the prosthesis 20 may include a mesh fabric using a knit structure that provides relatively large openings or pores to ensure good visibility of underlying anatomical structures without sacrificing the mechanical properties of the mesh. The porosity of the fabric allows for tissue infiltration to incorporate the prosthesis. The knit fabric is sufficiently strong and structured to eliminate or minimize the possibility of pullout of fixation fasteners, such as sutures, staples, and tacks. The repair fabric may be sufficiently flexible to facilitate easy size reduction for insertion into a surgical subject. In this manner, the flexible fabric can be folded into an elongated shape, such as a roll, and supported and advanced through a narrow laparoscopic cannula for use in laparoscopic surgery.

[0054] The mesh fabric may employ a relatively lightweight, thinner, and / or more flexible fabric structure that is less likely to introduce foreign material into the patient than other repair fabrics. The porous prosthetic repair fabric allows for a rapid fibroblast response through the interstices of the mesh to form a secure fibrous / prosthetic layer. The fabric may provide a thinner, more adaptable scar plate that can result in a soft tissue or muscle wall repair that is relatively comfortable for the patient.

[0055] In one exemplary embodiment shown in Figure 8, the repair fabric may include a knit mesh 80 including knitted strands of filaments 82 arranged in a uniform pattern that define larger primary pores 84. A pair of individual filaments 86 extends across the primary pores to define a plurality of smaller secondary pores 88 within the primary pores.

[0056] In the illustrated embodiment, the primary pores 84 are bounded by knit strands of filaments 82. However, it should be understood that one or more boundaries of the primary pores 84 can be defined by individual filaments, as would be apparent to one skilled in the art. As shown, the primary pores 84 can have a generally polygonal shape, such as a hexagon, diamond, or square, although aspects of the present disclosure are not limited thereto. In this regard, it should be understood that other pore shapes are contemplated, including, but not limited to, circular, non-circular, round, oval, etc., as would be apparent to one skilled in the art.

[0057] The prosthetic repair fabric may be configured to increase the fabric's flexibility and / or reduce the fabric's total weight per unit area. Such characteristics may allow the repair fabric to be more easily folded for introduction into a patient. These characteristics may also allow the repair fabric to be more easily manipulated around a surgical site within a patient. In one exemplary embodiment, the primary pores 84 have an area of ​​approximately 0.01032 to 0.01233 square inches before the mesh is formed into a three-dimensional contoured configuration. In this regard, less material may be used to produce a mesh of a given area, which may result in a lower weight mesh. Furthermore, the generally greater spacing between strands of filaments 82 associated with larger primary pores 84 may also contribute to a more flexible mesh. However, as will be apparent to those skilled in the art, the size of the primary pores may vary, and it should be understood that aspects of the present disclosure are not limited in this respect.

[0058] In some applications, it may be desirable to provide secondary pores 88 within the primary pores 84. In one exemplary embodiment shown in FIG. 8 , each primary pore 84 is subdivided into multiple secondary pores 88 by a pair of individual or single filaments 86. In the exemplary embodiment, the pair of filaments 86 divide the primary pore 84 into a pair of generally triangular secondary pores 90 and a generally rectangular secondary pore 92 positioned between the two generally triangular secondary pores 90. However, it should be understood that the shape of the secondary pores and / or the number of secondary pores within each primary pore can vary as desired, as would be apparent to one of ordinary skill in the art, and that aspects of the present disclosure are not limited in this respect.

[0059] 8 , a pair of individual filaments 86 extend substantially parallel to one another across the primary pore 84. As shown, a pair of parallel filaments 86 may be generally linearly aligned with a corresponding pair of filaments in an adjacent primary pore. However, it should be understood that the individual filaments may be positioned and oriented in other suitable arrangements, and aspects of the present disclosure are not limited in this respect.

[0060] The prosthetic repair fabric can be configured to be provisionally secured to tissue or muscle using a variety of fasteners, such as sutures, staples, spiral tacks, Q-rings, etc. The individual filaments 86 extending across the primary pores can provide additional features for engagement with fasteners used to secure the fabric. It should be understood that the repair fabric can be secured to tissue and / or mesh using fasteners, such as spiral tack and Q-ring structures, which have relatively small features for engaging and holding the repair fabric in place. The smaller secondary pores 88 associated with the individual filaments can be sufficiently strong and structured to provide improved engagement with fasteners to prevent or minimize pull-out. It should be understood that the size of the secondary pores can vary, and aspects of the present disclosure are not limited in this respect, as would be apparent to one skilled in the art.

[0061] Knit meshes can employ filaments of the same size or different relative sizes to adjust the mechanical properties of the fabric. In one exemplary embodiment, the mesh fabric can include first filaments 82 having a first diameter to form primary pores and second filaments 86 having a second diameter different from the first diameter that span the primary pores. In one embodiment, the second filaments 86 have a second diameter larger than the first diameter of the first filaments. Such a configuration can increase the stiffness of the mesh fabric, thereby improving the handleability of the mesh fabric. However, it should be understood that other configurations are also contemplated. For example, but not limited to, the diameter of the first filaments 82 can be larger than the diameter of the second filaments 86.

[0062] In one exemplary embodiment, the knit mesh 80 can be produced in a wrapping pattern by knitting a pattern in six courses over three needles using two partially threaded guide bars. The fabric structure can be an atlas type, where each knitted edge travels over three or more needles, which can prevent the mesh from fraying.

[0063] In one exemplary embodiment shown in FIGS. 9A-9B, the repair fabric may employ a double-bar warp knit mesh structure produced using two guide bars moving according to a first bar pattern chain (identified as reference numeral 94) of 4 / 2 4 / 6 4 / 2 6 / 8 6 / 4 6 / 8 and a second bar pattern chain (identified as reference numeral 96) of 6 / 8 2 / 0 6 / 8 4 / 2 8 / 10 4 / 2. The mesh may be knitted on a single-needle bar, 24-gauge Russell knitting machine. The mesh may be produced at approximately 34-36 courses per inch and approximately 12-17 wales per inch. However, it should be understood that any suitable knit pattern may be used to knit the mesh fabric, and aspects of the present disclosure are not limited in this respect, as would be apparent to one skilled in the art.

[0064] The knit mesh can be manufactured in a variety of widths, such as from 1 inch to 80 inches, as will be apparent to one skilled in the art, depending on the intended use for which the repair fabric is manufactured.

[0065] After knitting, the fabric can be washed to remove any residual processing lubricants or other contaminants. A cleaning agent such as Triton X-100 can be used to assist in the removal of such contaminants. As will be apparent to those skilled in the art, after washing, the mesh can be dried at a temperature below the heat-setting and melting temperature of the material.

[0066] Some embodiments of the knit mesh can be heat-set to impart shape memory to the mesh and to prosthetic fabrics formed from the mesh. In one exemplary embodiment, the fabric is heat-set to have a generally planar shape memory. In this manner, the fabric can be folded and inserted into a patient, then return to a planar configuration and properly positioned against the patient's tissue. It should be understood that other embodiments of the fabric may have shape memory corresponding to a non-planar configuration, or may have no shape memory at all, and aspects of the present disclosure are not limited in this respect.

[0067] If desired, the knit mesh can be heat-set under tension in a crochet hoop or tenter frame. Heat-setting can be performed while the mesh knit is stretched in a particular direction, facilitating the mesh setting into a particular configuration. In one exemplary embodiment, the knit mesh is stretched in the cross-knit direction while simultaneously partially relaxed or contracted to a certain point in the machine direction while heat is applied to set the mesh. However, it should be understood that other techniques apparent to those skilled in the art can also be used to heat-set the knit mesh, and aspects of the present disclosure are not limited in this respect.

[0068] In some applications, it may be desirable to smooth the knitted mesh to reduce the texture or surface roughness of the mesh. In one exemplary embodiment, the knitted mesh is lightly pressed between a pair of plates, including a heated plate, which presses against the rough surface of the mesh to reduce high spots on the mesh and heat-set the mesh to smooth its surface. However, it should be understood that any suitable process apparent to one skilled in the art may be used to smooth the fabric. For example, during the washing and drying process, the knitted mesh can be passed between a pair of heated rollers to smooth the fabric.

[0069] The filaments used to manufacture the repair fabric can contribute to the fabric's final mechanical properties. In one exemplary embodiment, the repair fabric is knitted using first filaments having a diameter of about 0.0045 to 0.0051 inches (first bar pattern chain), preferably about 0.0048 inches, and second filaments having a diameter of about 0.0063 to 0.0075 inches (second bar pattern chain), preferably about 0.0075 inches. Filaments of these diameters can contribute to increased flexibility and reduced weight per unit area of ​​the repair fabric overall. However, it should be understood that the fabric can be manufactured using filaments having any appropriate diameter, as would be apparent to one skilled in the art, suitable for the desired application, and that aspects of the present disclosure are not limited in this respect.

[0070] In one exemplary embodiment, the fabric has a thickness of about 0.022 to 0.024 inches, and preferably about 0.0225 to 0.0235 inches. In one exemplary embodiment, the fabric has a weight per unit area of ​​about 0.066 to 0.069 grams per square inch. However, it should be understood that the fabric can be manufactured to have any thickness and / or weight per unit area apparent to one of ordinary skill in the art that is suitable for the desired application, and that aspects of the present disclosure are not limited in this respect.

[0071] In one exemplary embodiment, the filaments used to manufacture the mesh fabric comprise polypropylene monofilaments, which are inert in the presence of infection, non-wettable, and have low foreign body reactivity. In one exemplary embodiment, the monofilaments are formed from Aran Biomedical ProTex Med polypropylene resins PPS50156 and PPS50157. In one embodiment, the first monofilament has a denier of approximately 98±11, and the second monofilament has a denier of approximately 240±20. In one embodiment, the first and second monofilaments have a tenacity of approximately 6.0 to 8.5 grams per denier, with a nominal tenacity of approximately 6.2 grams per denier. However, it should be understood that filaments of various configurations, properties, and / or materials can be employed to manufacture the fabric. For example, as will be apparent to one skilled in the art, the filaments can include multifilaments or monofilaments with different mechanical properties, and aspects of the present disclosure are not limited in this respect.

[0072] The preformed curved shape of the prosthesis can be obtained using any suitable manufacturing process. In one exemplary embodiment shown in Figure 8, the prosthesis is manufactured using a thermoforming process that includes placing a sheet of mesh fabric into a mold having the desired shape of the prosthesis, heating the fabric in the mold to a temperature of approximately 100°C to 200°C for about 5 to 60 minutes, and then cooling the fabric in the mold with a current of air having a temperature of approximately 15°C to 30°C for about 5 to 60 minutes.

[0073] The edges of the prosthesis can be welded by fusing the material together using ultrasonic welding. During this procedure, the prosthesis can be held between a vibration-generating element and an anvil configured to the specific dimensions of the prosthesis. In one embodiment, the edges are welded at a pressure of about 150 kPa to 800 kPa and an energy of about 100 to 5000 joules for a time of about 50 to 5000 milliseconds.

[0074] Once the sheet of mesh fabric is formed and the edges of the formed prosthesis are welded, the excess fabric extending beyond the welded edges is separated from the body of the prosthesis using a manual cutting procedure to form the finished prosthesis.

[0075] After inspection, the prosthesis may be packed into an inner packaging (shell and insert) specifically designed according to the three-dimensional characteristics of the prosthesis to conform to and protect the preformed curved shape of the prosthesis. The inner packaging may then be placed and packaged within an outer packaging for further protection. The entire assembly may then be sterilized using any suitable method, such as with ethylene oxide, to provide a sterile prosthesis ready for implantation. [Example]

[0076] The following examples are illustrative only and are not intended to limit the scope of the present disclosure.

[0077] The physical properties of a representative preformed three-dimensional contoured prosthesis fabricated from a double-bar warp-knit mesh fabric made from 0.0048-inch (first bar) and 0.0075-inch (second bar) polypropylene monofilament according to the exemplary embodiment shown in the figures (designated as Embodiment No. 1 in Table 1) were evaluated and compared to several known preformed three-dimensional contoured prostheses (comparison prostheses). Physical and performance properties tested included mesh thickness, pore size, mesh weight per unit area, suture pull-out strength, burst strength, tear resistance, tensile (break) strength, elongation at break, and stiffness. Test methods and results are shown in Table 1 below. Average results and ranges from several test samples are reported (ranges are shown in parentheses).

[0078] Suture pull-out strength: Mesh specimens measuring at least 1 inch x 1 inch (Embodiment No. 1) or at least 0.5 inches x 3 inches (Comparative Mesh Fabric) were prepared from preformed prostheses and clamped in the lower jaw of an MTS™ or equivalent tensile testing machine. The long dimension of the specimen should be parallel to the specimen's designated orientation (longitudinal or transverse). At least 0.5 inches (Embodiment No. 1) or at least 1 inch (Comparative Prosthesis) of the mesh was exposed above the jaws. A spring steel wire having a diameter of approximately 0.019 inches was placed through the mesh to simulate a suture. The wire was positioned 5 ± 1 mm from the edge of the mesh. The wire suture was looped back and both ends were attached to the upper jaw of the tensile machine. The suture was then pulled through the mesh at a rate of 5 inches per minute. The peak force was recorded for the specimens tested in both the longitudinal and transverse directions of the mesh, and the average force was calculated for all measurements in each direction.

[0079] Pore ​​size: A sample of mesh from a preformed prosthesis was placed in an optical coordinate measuring device such as Tesa Vision (35x magnification).

[0080] For embodiment number 1, each primary pore has a generally hexagonal shape, including two generally triangular pores and a generally rectangular pore in the central region. The length L of each leg of the primary pore was measured between each pair of end points AB, BC, CD, DE, EF, and FA, as shown by the dashed lines in Figure 3. The pore area of ​​the primary pore was calculated based on the area of ​​the hexagon as follows: where L 平均 is the average length of each leg. Area=(L 平均 ) 2 x(3√3) / 2 Randomly selected primary cells (pores formed by loops or knots not being counted) for each sample were measured and the average of these combinations was calculated.

[0081] Tensile (breaking) strength and elongation at break: A mesh sample from a preformed prosthesis, approximately 1 inch by 6 inches, was placed in the pneumatic jaws of an MTS™ tensile tester or equivalent device. The sample was oriented so that the knit direction being tested was parallel to the 6-inch length. The ends of the 6-inch sample were gripped between the lower and upper jaws of the tester. Starting with a minimum separation of 2 inches, the sample was pulled at a constant rate of 12 inches per minute until the sample broke. The peak load and elongation at break were recorded. The samples were tested in both the cross and machine directions. The average of the measurements taken from the sample for each direction was then calculated.

[0082] Mesh Thickness: Preformed prosthetic mesh samples were measured using a standard thickness snap gauge with a lightly spring-loaded pressure foot approximately 0.38 inches in diameter. Thickness was measured by lowering the foot onto the mesh. Measurements were taken to the nearest 0.0001 inch. A combined average was calculated for the total number of meshes measured.

[0083] Mesh Weight / Unit Area: Using multiple mesh sample sizes of at least about 2 inches by 2 inches from preformed prostheses, the weight of each sample was measured in grams to the nearest 0.0001 gram. The length and width dimensions were measured to the nearest 0.001 inch and the area was calculated by subtracting the area of ​​any rounded corners. The weight and unit area were used to calculate the weight per unit area for each sample. The weight per unit area for each sample was combined and averaged to calculate the average weight per unit area.

[0084] Burst Strength: This test method was derived from ANSI / AAMI VP20-1994 Section 8.3.3.2 and ASTM Ball Burst method D3787-01. A mesh sample from a preformed prosthesis was placed on a circular O-ring approximately 1 inch in diameter. The O-ring was placed on a grooved plate of a fixture with a hole in the center of the plate containing the O-ring. The fixture was attached to the lower jaw of an MTS™ or equivalent testing machine. The plate with the mesh was lifted and clamped to the upper plate of the fixture, compressing the mesh sample. The upper plate also contained a hole with the same diameter as the lower plate. The hole in the fixture plate was sized to accept a round ball-tipped rod with a 0.38 inch diameter tip, only slightly larger than the rod. The rod was connected to the upper jaw of the testing machine and moved down through the sample at a constant rate of 12 inches per minute. The peak load for the sample was recorded, and the average burst strength was then calculated based on the peak load for the sample.

[0085] Tear Resistance: Mesh samples from preformed prostheses were prepared, approximately 2 inches by 2 inches. A 1-inch slit was cut at the midpoint of one side (the direction being tested), creating two mesh sections. One section of the mesh was clamped to the lower jaw of a pneumatic fixture, and the other section was clamped to the upper jaw of the fixture. Starting with the jaws at a minimum separation of 1 inch, the mesh was pulled at a rate of 12 inches per minute until tearing was complete. The peak force was recorded. Samples were tested in the cross and machine directions (Embodiment No. 1) and the cross, machine, and diagonal directions (Comparative Mesh Fabric). The average across all measurements taken from the samples was then calculated for each group direction.

[0086] Stiffness: Stiffness testing is based on fabric stiffness via a circular bending procedure (see ASTM Standard D4032-08 (2016)). A preformed, three-dimensional, anatomically shaped prosthesis was placed on a plate with the dome of the formed mesh facing downwards. The mesh was centered over the orifice in the plate. The orifice was 1.5 inches in diameter with a chamfered lead-in. The mesh was forced or shoved into the plate with a 1-inch diameter plunger. The plunger was set to advance at a constant rate of 12 inches per minute. The plunger was advanced 1.5 inches below the top surface of the orifice platform and the peak load was recorded. The samples were tested and the average value for the entire group was calculated.

[0087] [Table 1]

[0088] It should be understood that the foregoing description of the present disclosure is intended to be merely illustrative of the present disclosure, and that other equivalents, embodiments, and modifications of the present disclosure are within the scope of the present disclosure as set forth in the appended claims.

Claims

1. 1. An implantable prosthesis for repairing an inguinal hernia, comprising: a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that independently assumes a curved shape configured to conform to a wall of a groin, the body being surrounded by an outer peripheral edge and including an apex relative to the outer peripheral edge, the body including a recess configured to receive an external iliac vessel, the recess extending in a direction from the apex toward the outer peripheral edge, the body including a first visual indicia provided on the body extending along at least a portion of the recess between the apex and the outer peripheral edge to facilitate positioning and / or placement of the prosthesis in the wall of the groin; Implantable prostheses, including:

2. The implantable prosthesis of claim 1 , wherein the first visual indicia extends from the apex.

3. The implantable prosthesis of claim 1 , wherein the first visual indicia includes a line extending along the recess.

4. An implantable prosthesis as described in claim 1, wherein the body includes one or more symbols for identifying the orientation of the prosthesis relative to the wall of the groin.

5. 2. The implantable prosthesis of claim 1, wherein the body includes a rounded ridge extending from the outer peripheral edge to at least the apex, the rounded ridge configured to be positioned along the axis of the inguinal ligament, and the body includes a second visual marking provided on the body extending along at least a portion of the rounded ridge between the outer peripheral edge and the apex to facilitate positioning and / or placement of the prosthesis in the wall of the groin.

6. The implantable prosthesis of claim 5 , wherein the second visual indicia extends through the apex.

7. The implantable prosthesis of claim 6 , wherein the second visual indicia comprises a line extending across the body.

8. The implantable prosthesis of claim 5 , wherein the first visual indicia extend in a first direction and the second visual indicia extend in a second direction transverse to the first direction.

9. The implantable prosthesis of claim 1 , wherein the body includes a convex outer surface and a concave inner surface.

10. 1. An implantable prosthesis for repairing an inguinal hernia, comprising: a body of biocompatible prosthetic material having a preformed three-dimensional contoured shape that spontaneously assumes a curved shape configured to conform to a wall of a groin, the body being surrounded by an outer peripheral edge and including an apex relative to the outer peripheral edge, the body including a rounded ridge extending from the outer peripheral edge to at least the apex, the rounded ridge configured to be disposed along an axis of an inguinal ligament, the body including a first visual indicia disposed on the body extending along at least a portion of the rounded ridge between the outer peripheral edge and the apex to facilitate positioning and / or placement of the prosthesis in the wall of the groin; Implantable prostheses, including:

11. The implantable prosthesis of claim 10 , wherein the first visual indicia extends from the apex.

12. The implantable prosthesis of claim 10 , wherein the first visual indicia extends through the apex.

13. The implantable prosthesis of claim 10 , wherein the first visual indicia comprises a line extending across the body.

14. An implantable prosthesis as described in claim 10, wherein the body includes one or more symbols for identifying the orientation of the prosthesis relative to the wall of the groin.

15. 11. The implantable prosthesis of claim 10, wherein the body includes a first curved surface and a second curved surface, the rounded ridge being located between the first curved surface and the second curved surface, and the second curved surface being steeper relative to the outer peripheral edge than the first curved surface.

16. The implantable prosthesis of claim 10 , wherein the body includes a convex outer surface and a concave inner surface.

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