Stabilizing embroidery for surgical repair graft

Abstract

Embroidery patterns for reinforcing and stabilizing a substrate for a surgical graft. A substrate stabilizing pattern is sewn into a substrate for reinforcing the substrate and supporting a subsequently added compliance control pattern. The substrate stabilizing pattern may have a specific arrangement for anchoring corner stitches of the compliance control embroidery pattern. In some examples, the substrate stabilizing pattern cooperates with the compliance control embroidery pattern to provide customized compliance performance.

Description

STABILIZING EMBROIDERY FOR SURGICAL REPAIR GRAFTCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 606,060, titled “STABILIZING EMBROIDERY FOR SURGICAL REPAIR GRAFT,” and filed on December 4, 2023, which is herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.FIELD

[0003] The apparatuses and methods described herein relate generally to surgical grafts and medical textiles useful for soft tissue reconstruction, regeneration, or repair. More particularly, described herein are surgical implants for soft tissue repair that include embroidered filament arrangement that stabilize a graft substrate.BACKGROUND

[0004] Soft tissues within a body may benefit from repair or reinforcement due to a variety of reasons such as disease, enhancement, or trauma. An implant or graft may be used to repair or reinforce a soft tissue, such as an unhealthy or modified tissue in the body. The tissue may, for example, be tissue that is no longer able to maintain its shape or physiological function such as a hernia or a tissue for which a shape or size change is desired such as breast size or shape change due to breast enhancement or breast reconstruction.

[0005] Some implant grafts include a substrate embroidered with a reinforcing yarn. In some cases, the yarn is arranged in a stitch pattern that alters the physical properties of the substrate to improve its performance when implanted into a patient’s body. For example, the yarn may be woven into a pattern that reinforces a strength of the substrate and also provides a certain degree of compliance. However, some substrates do not have a stable construction or rigidity, thereby making it very difficult or impossible to support an embroidery stitching. For example, the substrate may be very thin, delicate and / or porous, making it difficult to create an embroidery pattern in the substrate.

[0006] Therefore, there is a need for improved embroidered surgical repair materials and embroidery techniques for forming surgical repair materials.SUMMARY OF THE DISCLOSURE

[0007] Described herein are surgical grafts that include a substrate-stabilizing embroidery pattern that is configured to support the substrate for further embroidery, including for stitching a structural pattern of embroidery. Thus, these methods and apparatuses (e.g., devices and systems, including in particular, surgical grafts) are configured to be used with substrate materials that are not sufficient by themselves to support an embroidered pattern. Such substrates may include very fragile or delicate substrates, e.g., very thin materials and / or materials having a very low tear strength, particularly when inserted into the body. Without the benefits of the methods and apparatuses, e.g., stitching patterns, described herein these substrates may not be capable of supporting an embroidered pattern without the pattern tearing and / or deforming either during fabrication of the graft, implantation of the graft, and / or once implanted into a patient’s body. For example, without these methods and apparatuses may be used with substrates having very low tear strength and / or substrates having very large pore diameters, in order to provide a surgical graft having a structurally supportive embroidery pattern that may retain and support tissue when implanted into the body, even where the substrate material is absent or otherwise has a very low strength.

[0008] In general, the structural pattern embroidered onto the surgical grafts described herein may modulate the tensile strength and compliance of the substrate, ultimately based entirely or nearly entirely on the strength of the embroidered pattern In any of these examples the structural pattern may be a compliance control pattern that may provide directional control of the compliance of the substrate. The surgical grafts described herein may be, or be part of, a soft tissue repair graft, such as a repair scaffold, a patch, or a mesh for repairing a hernia or for breast reconstruction.

[0009] For example described herein are surgical grafts comprising: a substrate; a plurality of adjacent rows of substrate-stabilizing lengths of filament sewn into the substrate; and a structural pattern comprising a left-and-right alternating lockstitch pattern of one or more lengths of filaments sewn into the substrate forming a plurality of alternating left and right vertices, wherein each left vertex is positioned on opposite sides of two or more adjacent rows of the substrate-stabilizing lengths of filaments as compared to a next right vertex in the sequence; wherein the substate comprises either or both: a tear strength that is 300 milliNewtons (mN) or less, and / or an average pore diameter that is greater than a stitch length of the left-and-right alternating pattern of lockstitched lengths of filaments.

[0010] The structural pattern may comprise a comer lock pattern wherein at least some of the left vertices interlock with right vertices. The structural pattern may provide a support having a strength that is based on the combination of the pattern and the filament type (material, thickness, number of strands, etc.). In general, the substrate may provide very little, or no, structural support.

[0011] Any of these surgical grafts may include a second plurality of adjacent rows of substrate-stabilizing lengths of filament sewn into the substrate. The second plurality of adjacent rows may be perpendicular to the first plurality of adjacent rows (e.g., forming a square or rectangular grid), or may be at an angle relative to the first plurality of adjacent rows (e.g., forming a diamond pattern).

[0012] In some examples the adjacent rows of substrate-stabilizing lengths of filament sewn into the substrate are lockstitched lengths of filament sewn into the substrate. In any of these examples the structural pattern may be configured to form a corner lock pattern wherein at least some of the left vertices overlap with right vertices of an adjacent length of the left- and-right alternating lockstitched pattern.

[0013] As mentioned, these methods and apparatuses may, surprisingly, be used with substrates that were not previously believed to be useful for embroidered grafts, as the embroidered pattern would tear or deform (e.g., slide, move, etc.) relative to the substrate. For example the substrate may a very thin and / or delicate material, such as a tissue-paper material, such as a material having a low tear strength (e.g., a tear strength that is 600 mN or less, 500 mN or less, 400 mN or less, 350 mN or less, 300 mN or less, 250 mN or less, 200 mN or less, 150 mN or less, 100 mN or less, etc.). For example, the substrate may comprise a sacrificial layer having tear strength that is less than 300 milliNewtons (mN) when implanted into a body. In any of these methods and apparatuses, the tear strength may be the tear strength within the body (e.g., when implanted into the patient’s body, either immediately after implantation or shortly after implantation, e.g., within a few hours, days, weeks, etc.). The tear-strength may refer to the wet (e.g., saturated) tear strength.

[0014] In any of these methods an apparatuses the substrate may refer to a mesh material having a relatively large pore size (e.g., pore diameter). The mesh may have an average pore diameter (over the region being embroidered) that is greater than the stitch length of the structural pattern.

[0015] Any of the surgical grafts and method of making and using them described herein may have a left-and-right alternating lockstitch pattern that comprises a zig-zag pattern, a sinusoidal pattern, etc. Etc. As used herein a vertex of a left-and-right alternating lockstitchpattern may refer to the vertex region. The left-and-right alternating lockstitch pattern may have an upper and lower (or left and right) maximum / minimum distance.

[0016] For example, a surgical graft may include: a substrate; a plurality of adjacent rows of substrate-stabilizing lengths of filament sewn into the substrate; and a structural pattern configured as a comer lock pattern comprising a left-and-right alternating lockstitch pattern of lengths of filaments sewn into the substrate forming a sequence of alternating left and right vertices, wherein each left vertex is positioned on an opposite side of two or more adjacent rows of the substrate-stabilizing lengths of filaments as compared to a next right vertex in the sequence, further wherein a plurality of the left and right vertices interlock; wherein the substate comprises either or both: a tear strength that is less than 300 milliNewtons (mN) and / or an average pore diameter that is greater than a stitch length of the left-and-right alternating pattern of lockstitch lengths of filaments.

[0017] In some examples the surgical graft includes: a substrate; a substrate-stabilizing pattern comprising one or more lengths of filament sewn into the substrate; and a corner lock pattern sewn into the substrate over the substrate-stabilizing pattern, wherein the comer lock pattern comprises: a first lockstitch pattern that includes a series of first vertices; and a second lockstitch pattern that includes a series of second vertices that interlock with the series of first vertices of the first lockstitch pattern to form a plurality of comer locks, wherein the first and second lockstitch patterns intersect the substrate-stabilizing pattern such that a vertex of the first lockstitch pattern is on a first side of the substrate-stabilizing pattern and a vertex of the second lockstitch pattern is on a second side of the substrate-stabilizing pattern to anchor the series of first and second vertices.

[0018] In any of these grafts the substrate-stabilizing pattern may comprise a plurality of adjacent rows of lengths of filament sewn into the substrate. The plurality of adjacent rows may be arranged in parallel or nearly parallel. In some cases the plurality of adjacent rows may be arranged at an angle to each other.

[0019] In any of these examples, the threads of the second lockstitch pattern may intersect and envelope threads of the first lockstitch pattern.

[0020] In any of these surgical grafts, the first vertices of the series of first vertices may be equidistantly spaced apart, and wherein second vertices of the series of second vertices are equidistantly spaced apart.

[0021] As mentioned, the first and / or second lockstitch patterns may be a zigzag pattern, a sinusoidal pattern, etc.

[0022] The substrate may comprise a porous material having an average pore diameter that is greater than a stitch length of the first or second lockstitch pattern. The substratematerial may be mesh, a foam, or a stretchy film. As mentioned, the substrate may comprise a material having a tear strength that is 300 milliNewtons (mN) or less. As mentioned, in any of these grafts, the substrate may comprise a sacrificial layer. For example, the substrate may comprise a material that dissolves, tears-away, etc. The sacrificial layer may be removed prior to implanting into the body. In general, the substrate may be a thin or delicate sheet of material. The material may be biocompatible. In some examples, the substrate may include one or more of: a collagen sheet, a hyaluronic acid sheet, a knit, a weave, a braid, a nonwoven material, a meltblown material, an electrospun sheet, a biotextile material and a latex material.

[0023] The surgical graft may be configured as, for example, a hernia repair graft or a breast reconstruction graft.

[0024] Also described herein are methods of forming a surgical graft. For example, a method of forming a surgical graft may include: sewing a substrate-stabilizing pattern in a substrate, wherein the substrate-stabilizing pattern comprises a plurality of adjacent rows; and sewing a structural pattern in the substrate comprising a left-and-right alternating lockstitch pattern forming a sequence of alternating left and right vertices, wherein each left vertex is positioned on an opposite side of two or more adjacent rows of the substrate-stabilizing pattern as compared to a next right vertex in the sequence; wherein the substrate is formed of a material having a tear strength when implanted into a body that is 300 milliNewtons (mN) or less and / or an average pore diameter that is greater than a stitch length of the left-and-right alternating pattern of lockstitched lengths of filaments.

[0025] Any of these methods may include sewing the substrate-stabilizing pattern by sewing a plurality of parallel adjacent rows.

[0026] In any of these methods and apparatuses, the structural pattern may comprise a corner lockstitch pattern in which a plurality of the left and right vertices interlock with each other. The structural pattern may therefore form an embroidered mesh or network having desirable properties (e.g., compliance, stretch, strength, etc.) even after removal or degradation of the substrate, as described herein.

[0027] Any of these methods and apparatuses may include left and right vertices that are equidistantly spaced apart. As mentioned, the structural pattern may comprise a zigzag or sinusoidal pattern.

[0028] The substrate may be any of the substrates described herein, including delicate or removable substrates.

[0029] According to one example, a method of forming compliance control embroidery pattern in a substrate includes: sewing a substrate-stabilizing pattern in a substrate; andsewing a comer lock pattern in the substrate over the substrate-stabilizing pattern by: sewing a first lockstitch pattern that includes a series of first vertices, wherein the first lockstitch pattern intersects the substrate-stabilizing pattern such that the substrate-stabilizing pattern anchors the series of first vertices; and sewing a second lockstitch pattern that includes a series of second vertices that interlock with the series of first vertices of the first lockstitch pattern to form a plurality of comer locks, wherein the second lockstitch pattern intersects the substrate-stabilizing pattern such that the substrate-stabilizing pattern anchors the series of second vertices. The substrate-stabilizing pattern may include a line, and the series of first vertices may be on a first side of the line and the series of second vertices may be on a second side of the line that is opposite the first side of the line. The substrate-stabilizing pattern may include a line that runs between the series of first vertices and the series of second vertices. The substrate-stabilizing pattern may include a line and each of the first and second lockstitch patterns envelopes the line. Sewing the substrate-stabilizing pattern may include sewing a plurality of lines arranged in parallel. The substrate-stabilizing pattern may include a lockstitch pattern. Threads of the second lockstitch pattern may intersect and envelope threads of the first lockstitch pattern. Each of the first and second lockstitch patterns may include an upper thread that interlocks with a lower thread. First vertices of the series of first vertices may be equidistantly spaced apart, and second vertices of the series of second vertices may be equidistantly spaced apart. Each of the first and second lockstitch patterns may be a zigzag pattern include a plurality of repeating angles at corresponding first and second vertices. Each of the first and second lockstitch patterns may be arranged along a winding path along the substrate.

[0030] Also described herein are methods of using any of the grafts described herein, including methods of repairing or reconstructing soft tissue in the body of a subject in need thereof. For example, a method may include implanting any of the surgical grafts described herein at a location in need of soft tissue repair or reconstruction. For example, the location may be a hernia, a reconstruction site (e.g., breast, etc.).

[0031] According to another example, a surgical graft includes: a substrate; a substratestabilizing pattern sewn into the substrate; and a corner lock pattern sewn into the substrate over the substrate-stabilizing pattern, wherein the corner lock pattern includes: a first lockstitch pattern that includes a series of first vertices; and a second lockstitch pattern that includes a series of second vertices that interlock with the series of first vertices of the first lockstitch pattern to form a plurality of corner locks, wherein the first and second lockstitch patterns intersect the substrate-stabilizing pattern such that the substrate-stabilizing pattern anchors the series of first and second vertices. The substrate-stabilizing pattern may include aline that runs between the series of first vertices and the series of second vertices. The substrate-stabilizing pattern may include a line, and the series of first vertices are on a first side of the line and the series of second vertices are on a second side of the line that is opposite the first side of the line. The substrate-stabilizing pattern may include a line and each of the first and second lockstitch patterns envelopes the line. The substrate-stabilizing pattern may include a plurality of lines arranged in parallel. The substrate-stabilizing pattern may include a lockstitch pattern. Threads of the second lockstitch pattern may intersect and envelope threads of the first lockstitch pattern. Each of the first and second lockstitch patterns may include an upper thread that interlocks with a lower thread. First vertices of the series of first vertices may be equidistantly spaced apart, and second vertices of the series of second vertices may be equidistantly spaced apart. Each of the first and second lockstitch patterns may be a zigzag pattern including a plurality of repeating angles at corresponding first and second vertices. Each of the first and second lockstitch patterns may be arranged along a winding path along the substrate. The substrate may include a porous material. The porous material may be a flexible mesh, a flexible foam, or a stretchy film. The substrate may include a thin or delicate sheet of material. The substrate may include one or more of: a collagen sheet, a hyaluronic acid sheet, a knit, a weave, a braid, a nonwoven material, a meltblown material, an electrospun sheet, a biotextile material and a latex material. The surgical graft may be a hernia repair graft or a breast reconstruction graft.

[0032] According to a further example, a method for repairing or reconstructing soft tissue in the body of a subject in need thereof includes: implanting, at a location in need of soft tissue repair or reconstruction, an implant including: a substrate; a substrate-stabilizing pattern sewn into the substrate; and a comer lock pattern sewn into the substrate over the substrate-stabilizing pattern, wherein the corner lock pattern includes: a first lockstitch pattern that includes a series of first vertices; and a second lockstitch pattern that includes a series of second vertices that interlock with the series of first vertices of the first lockstitch pattern to form a plurality of comer locks, wherein the first and second lockstitch patterns intersect the substrate-stabilizing pattern such that the substrate-stabilizing pattern anchors the series of first and second vertices. The location may include a hernia. The location may include a breast. The substrate-stabilizing pattern may include a line that runs between the series of first vertices and the series of second vertices. The substrate-stabilizing pattern may include a plurality of lines arranged in parallel. The substrate-stabilizing pattern may include a lockstitch pattern.

[0033] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are notmutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0034] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0035] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0036] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0037] FIGS. 1A-1E illustrate example aspects of stitching patterns as described herein.

[0038] FIGS. 2A-2E illustrate example problems associated with stitching an unstable substrate.

[0039] FIGS. 3 A-3D illustrate an example of forming a stabilized embroidery pattern(including, but not limited to a comer-lock stitching pattern) in a delicate or large-pore substrate using a substrate-stabilizing pattern.

[0040] FIGS. 4A-4F illustrate examples of the operation of a substrate-stabilizing pattern to enhance the embroidery of a delicate or large-pore substrate receiving a structural stitching (embroidered) pattern, such as (but not limited to) a corner lockstitch pattern to modify physical characteristics of the substrate such as compliance.

[0041] FIG. 5 schematically illustrates an example method of forming a substratestabilizing embroidery pattern and a compliance corner lock pattern in a substrate.DETAILED DESCRIPTION

[0042] Described herein are method and apparatuses (e.g., devices and systems, and in particular surgical grafts) in which the embroidered pattern is self-stabilized, so that the strength and other mechanical characteristics of the grafts may be due almost entirely from the final embroidered pattern, even where the substrate being embroidered is itself delicateand / or non-supporting of the embroidered pattern. For example, These methods and apparatuses may include an embroidered (e.g., sewn) structural pattern that is limited in movement when force (e.g., tension) is applied due to interaction with a stabilizing embroidered pattern that is applied to the otherwise non-anchoring / non-supportive substate prior to applying the structural pattern. Without the use of the stabilizing embroidered pattern engaging the structural pattern, the substrate would otherwise allow the structural pattern to move and deform.

[0043] Embroidery can alter the mechanical properties of a substrate, such as (but not limited to) compliance of the substrate. For example, the compliance may be modified, including directionally modifying the substate compliance or modifying it isotopically. In addition, embroidery can create structures like corner lock features. However, some substrates are not adequate to provide a stable platform during the embroidery process, and may prevent the forming of some desired embroidery patterns. These substrates may be less stable and / or may inhibit desired embroidery patterns. Examples of these substrates include thin collagen sheets, hyaluronic acid sheets, knits, weaves, braids, nonwovens, meltblowns, electrospun sheets, and other biotextiles. Such substrates may have a very low tear strength (e.g., a tear strength that is 600 mN or less, 500 mN or less, 400 mN or less, 350 mN or less, 300 mN or less, 250 mN or less, 200 mN or less, 150 mN or less, 100 mN or less, etc.). The low tear strength may result in deformation of the pattern as the substate is stitched. In some cases the substrate may be a porous material having a pore diameter that is greater than then stitch length for the embroidered pattern. Such substrates may therefore make the desired construction of the embroidery features challenging or impossible. These substrates may be referred to herein as non-anchoring or unstable substrates, as they may not allow anchoring of the embroidered pattern in a stable manner as may be required to fabrication and use of the embroidered graft.

[0044] The embroidery patterns described herein may therefore include reinforcing and stabilizing embroidery patterns applied to a substrate resulting in performance enhancing embroidery. The stabilizing embroidery pattern may have a predetermined arrangement of stitch patterns specifically positioned on the substrate to anchor portions of the performance enhancing embroidery. The performance enhancing embroidery may be configured to strengthen the substrate and provide different degrees of compliance depending on stretching direction. In some examples, the stabilizing embroidery pattern cooperates with the performance enhancing embroidery to enhancing the performance of the substrate.

[0045] The embroidered substrates may be, or be part of, a surgical graft. The grafts may be implants for soft tissue repair and / or regeneration applications, such as hernia repair, orbreast reconstruction. In some cases, the implant provides a base scaffold that supports the repaired area until the patient’s body self-repairs, for example, as the patient’s cells infiltrate the surgical material and generate new tissue. In other cases, the patient’s body will not completely self-repair, or the repair will not be sufficiently strong such that the implant stands in for, or permanently reinforces, natural tissue. In the former case, it is often desired that the implant remain in place until the repaired tissue can shoulder the load forces, though this may be a slow and developing process that takes place over time. Examples of a surgical graft having performance enhancing embroidery patterns are described in U.S. Patent No. 10,213,284 and U.S. Patent No. 10,426,587, each of which is incorporated herein by reference in its entirety.

[0046] FIGS. 1A-1E show example aspects of stitching (embroidery) patterns, including lockstitch patterns (FIGS. 1 A-1D) and corner lockstitch patterns (FIGS. 1C and ID) that may be embroidered into a substrate to alter the performance of the substrate for implementation in a surgical graft. FIG. 1 A shows an example portion of a lockstitch pattern sewn in a direction 107. The lockstitch pattern includes a top thread 101 on one side of a substrate and a bottom thread 103 on the opposite side of the substrate. The top thread 101 interlocks with the bottom thread 103 in the substrate at a lockstitch location 105. FIG. IB shows a closeup view of an example lockstitch location 105 of the lockstitch pattern of FIG. 1 A.

[0047] FIG. 1C shows an example of two lockstitch patterns 106 and 108 arranged in a corner lockstitch pattern. A first lockstitch 106 is embroidered in a first run direction 109 and a second lockstitch 108 is embroidered in a second run direction 111. Each of the first and second lockstitch patterns 106 and 108 includes a periodic arrangement of angled vertices (i.e., triangles), thereby forming a zig-zag pattern. FIG. 1C shows a close up view of a corner lock 113 formed by a first vertex 110 of the first lockstitch pattern 106 and a second vertex 112 of the second lockstitch pattern 108. As shown, the second vertex 112 overlaps and interlocks with the first vertex 110 forming a box shape. In this example, the top and bottom threads of the second lockstitch pattern 108 overlap the top and bottom threads of the first lockstitch pattern 106. That is, the second lockstitch pattern 108 envelopes the threads of the first lockstitch pattern 106 to form the comer lock 113. This corner lockstitch pattern can enhance the tensile strength of the substrate (and the resulting graft) by reinforcing the substrate. In addition, the corner lockstitch pattern can directionally modulate compliance of the resulting graft. For example, the corner lockstitch pattern may inhibit stretching in one axis along a plane of the substrate and permit stretching in another axis along the plane of the substrate. Such compliance modulating stitching pattern may be referred to as a compliance control pattern.

[0048] FIG. ID shows another example of a corner lock pattern. A first lockstitch pattern 116 is embroidered in a first run direction 119 and a second lockstitch pattern 118 is embroidered in a second run direction 121 from a plurality of lockstitch stitches 125. Each of the first and second lockstitch patterns 116 and 118 includes a periodic arrangement of angled vertices (i.e., triangles), thereby forming a zig-zag pattern. The angled vertices of the first and second lockstitch patterns 116 and 118 are more acute compared to the lockstitch patterns of FIG. 1C, thereby providing the substrate different compliance (stretching) resistance properties compared to the corner lock arrangement 123 of FIG. 1C. Thus, the vertex angles of a comer lock pattern may be varied to provide a customized compliance to the substrate and graft.

[0049] FIG. IE shows a top view an example of an arrangement of parallel lengths 130 of a lockstitch pattern on a substrate. For example, a stitching pattern may follow an embroidery run direction 132 along a plane of the substrate along a first length or line, and a second line of stitches (e.g., lockstitch stitches 117) may be arranged adjacent to the first, in a continuous line or path 130.

[0050] In general, these stitching patterns may be made into a substrate. In any of the example stitching patterns of FIGS. 1 A-1E, if the substrate is too thin, delicate and / or porous, the substrate may not be able to maintain the corner lock arrangement. For example, the more unstable the substate, the larger the corner lock (e.g., 113 or 123) may have to be, which may have an undesirable effect on performance of the graft in some cases.

[0051] FIGS. 2A-2E illustrate examples of the problems associated with non-anchoring (e.g., unstable) substrates described above. FIG. 2A shows an example of a left-and-right alternating lockstitch pattern, configured as a triangular (e.g., zigzag) lockstitch pattern 202, that is sewn into an anchoring substrate 200 with lockstitch locations (e.g., 201) where the upper and lower filaments (e.g., yarns, fibers, strands, etc.) of the lockstitch pattern 202 interlock with each other, as previously discussed. The left-and-right alternating lockstitch pattern includes a series of vertices (e.g., 203) forming the triangular (e.g., zigzag) pattern. In this case, the substrate 200 is sufficient stable (e.g., rigid, thick, and / or non-porous) to support and maintain the shape of the lockstitch pattern 202, including at the vertices (e.g., 203) of the triangle pattern.

[0052] FIG. 2B shows an example of a triangle lockstitch pattern 205 sewn into an unstable (non-anchoring) substrate 210. In this case, the substrate 210 has an open pore structure (e.g., loose mesh) having numerous openings 204. The pore size of the substrate in this example has a diameter that is greater than the stitch length of the embroidery pattern, as shown by the distance between the lockstitch locations 201. As a result, the stitch length maybe permitted to change between the lockstitch points. Other examples of unstable substrate structures may include a flexible foam, a stretchy film, or a weak (e.g., thin and / or non-rigid) sheet of material. In some cases, the substrate is unstable because it deforms significantly as the filament(s) (e.g., yarn, strand, etc.) is stitched into the substrate.

[0053] As shown in the closeup view of FIG. 2C, because the substrate 210 does not provide a stable platform for stitching, the threads at the vertices (e.g., 206) of the lockstitch pattern 205 will shift toward the most stable positions on the substrate 210. For example, if an initial and target location 208 of a vertex 206 is located within an opening 204 of the substrate 210, tension (e.g., in the embroidery filament) will cause the vertex 206 to pull toward a centerline 228 of the lockstitch pattern 205 and anchor to the closest stable part of the substrate 210, i.e., ending location 207. Thus, the vertex 206 is shifted a distance 211 from its intended position 209. Further, the vertex 206 has a blunted shape, as shown in FIG. 2D, instead of having the sharp shapes of the vertices in the example of FIG. 2 A with the more stable substrate 200. If an overlapping pattern (e.g., a corner-lock pattern is desired, as shown in FIG. 2E) is desired, it may be necessary to more closely overlap the two patterns, resulting in a comer lock arrangement that may have an undesirable decreased stretching amplitude in a corresponding direction of the graft, thus not providing the desired compliance performance for the graft.

[0054] FIG. 2E shows an example where the vertices of a first lockstitch pattern 205 are blunted to a degree that they are too far from their intended locations to overlap with corresponding vertices of a second lockstitch pattern 207. Thus, the lockstitch patterns 205 and 207 will not form a corner stitch pattern in an intended intersection region 214. The resulting graft will not have the intended performance benefits of the corner lock arrangement previously discussed. Note that in FIG. 2E the position of the vertices in the right-side filament 207 (e.g., the second lockstitch pattern) is exaggerated, and is shown closer tot the left than it may actually appear given the mesh substrate shown. In practice, the lockstitch stitching to the left of the gridline 215 shown may more likely be pulled against the gridline 215, even further separating from the first filament (e.g., first lockstitch pattern 205).

[0055] To address this, the method and surgical grafts described herein may instead include a plurality of substrate-stabilizing lengths of filament sewn into the substrate. These substrate-stabilizing lengths of filament may provide anchors for the structural pattern. The substrate-stabilizing lengths of filament may be formed of the same filament material as the structural pattern filament or a different material (e.g. having a different composition, thickness / weight, etc.). The use of a plurality of substrate-stabilizing lengths of filament sewn into the substrate may provide a scaffolding for securing the structural pattern, even wherethe substate is too delicate (and may tear) or includes gaps / openings (pores) that are otherwise too large.

[0056] FIGS. 3 A-3D illustrate an example of forming a compliance control pattern in a substrate that is reinforced with a substrate-stabilizing embroidery pattern to address the problems discussed above. FIG. 3 A shows a low-resistance porous substrate 310 that includes numerous pores (e.g., 304), and is unable to support embroidery of a compliance control pattern. FIG. 3B shows a substrate-stabilizing pattern 320 sewn into the substrate 310. In this case, the substrate-stabilizing pattern 320 includes a number of lines (e.g., 321a, 321b and 321c) that are arranged in parallel and spaced apart by a distance D. Although the substrate 310 is unstable, the straight lines 321a, 321b and 321c may more easily be embroidered into the substrate 310 with minimal or no support (e.g., as opposed to a more complicated (e.g., zigzag) pattern). In some examples, the substrate-stabilizing pattern 320 is a lockstitch pattern, in which upper and lower filaments interlock at lockstitch locations (e.g., 322) as previously discussed. The lockstitch pattern may provide performance benefits (e.g., directional compliance) compared to other stitching patterns. For example, a lockstitch pattern may allow the substrate-stabilizing pattern 320 to contribute to the compliance modulation of the substrate, which is described further herein.

[0057] FIG. 3C shows a first lockstitch pattern 305 of a corner lock pattern sewn into the substrate 310 and over the substrate-stabilizing pattern 320. The first lockstitch pattern 305 is a triangle (e.g., zigzag) pattern that includes a first series of vertices 324 on one side of the first lockstitch pattern 305 and a second series of vertices 326 on the other side of the first lockstitch pattern 305.

[0058] The distance D between the lines 321a, 321b and 321c of the substrate-stabilizing pattern 320 are arranged to anchor the first series of vertices 324 and the second series of vertices 326 of the first lockstitch pattern 305. For example, the first lockstitch pattern 305 intersects and crosses over a line 321a of the substrate-stabilizing pattern 320 such that the first series of vertices 324 is located on the opposite side of the line 321a than a centerline 328 of the first lockstitch pattern 305. The line 321a is located sufficiently close to the intended locations of the first series of vertices 324 to prevent the first series of vertices 324 from shifting toward the centerline 328, thereby anchoring the first series of vertices 324 to their intended locations relative to the substrate 310. Likewise, the second series of vertices 326 is located on the opposite side of a line 321b than the centerline 328 of the first lockstitch pattern 305. The line 321b is located sufficiently close to the intended locations of the second series of vertices 326 to prevent the second series of vertices 326 from shifting toward thecenterline 328, thereby anchoring the second series of vertices 326 to their intended locations relative to the substrate 310.

[0059] FIG. 3D shows a second lockstitch pattern 307 of the corner lock pattern sewn into the substrate 310 and over the substrate-stabilizing pattern 320. Like the first lockstitch pattern 305, the second lockstitch pattern 307 is a triangle (e.g., zigzag) pattern that includes series of vertices on both sides of the second lockstitch pattern 307. The distance D between the lines 321a, 321b and 321c of the substrate-stabilizing pattern 320 are also arranged to anchor the vertices of the second lockstitch pattern 307. That is, the locations of the vertices of the second lockstitch pattern 307 are anchored by lines 321b and 321c, thereby preventing the vertices of the second lockstitch pattern 307 from shifting away from their intended locations relative to the substrate 310.

[0060] The second lockstitch pattern 307 is sewn over the first lockstitch pattern 305 to create corner locks (e.g., 323a, 323b and 323c), thereby providing the intended differentiated compliance performance to the graft. As shown, the line 321b runs between vertices of the first lockstitch pattern 305 and the second lockstitch pattern 307 where the corner locks 323a, 323b and 323c are located. Thus, the line 321b anchors portions of the first lockstitch pattern 305 and the second lockstitch pattern 307.

[0061] As shown in FIGS. 3 A-3D, the left-and-right alternating lockstitch patterns of one or more lengths of filaments sewn into the substrate form a plurality of alternating left and right vertices. Each left vertex is positioned on opposite sides of two or more adjacent rows of the substrate-stabilizing lengths of filaments as compared to a next right vertex in the sequence. This allows the vertices to overlap across the length of the substate-stabilizing filament length, anchoring them in position.

[0062] In this example, the substrate-stabilizing pattern 320 anchors the vertices of the first lockstitch pattern 305 and the second lockstitch pattern 307. For example, as shown in FIG. 3D, lockstitches forming the left vertices 326a, 326b, 326c are on one side of the line 321b, while the lockstitches forming the right vertexes 344a, 344b, 344c are on the opposite side of the line 321b, with the left and right vertices overlapping. This may allow limit the filaments forming the left and right vertices from moving.

[0063] In some cases, the substrate-stabilizing pattern may be configured to contribute to the compliance characteristics of the substrate and resulting graft. FIGS. 4A-4F illustrate how a substrate-stabilizing pattern may cooperate with a comer lockstitch pattern to modify the compliance characteristics of a substrate. FIGS. 4A-4F show an intersection region where a first lockstitch pattern 425 intersects a second lockstitch pattern 427. In some examples, the first lockstitch pattern 425 corresponds to a line of a substrate-stabilizing pattern (e.g. line321a, 321b or 321c in FIG. 3D) and the second lockstitch pattern 427 corresponds to a portion of a zigzag lockstitch pattern (e.g., 305 or 307 in FIG. 3D). As shown, each of the first and second lockstitch patterns 425 and 427 includes an upper thread that interlocks with a lower thread at lockstitch locations.

[0064] In the example of FIGS. 4A-4F, the second lockstitch pattern 427 envelopes the first lockstitch pattern 425. That is, the upper thread of the second lockstitch pattern 427 overlays the upper thread of the first lockstitch pattern 425, and the lower thread the second lockstitch pattern 427 overlays the lower thread of the first lockstitch pattern 425. This may allow movement of the first lockstitch pattern 425 along its run direction 430 relative to the second lockstitch pattern 427, thereby providing some compliance of the substrate / graft along this run direction 430.

[0065] Movement of the second lockstitch pattern 427 along its run direction 435 is more limited than movement of the first lockstitch pattern 425 along its run direction 430 due to the intersection with the first lockstitch pattern 425. To illustrate, FIGS. 4A and 4B show perspective and top-down views, respectively, of the intersection region in a state where the second lockstitch pattern 427 intersects a midway point between two lockstitch locations 432a and 432b of the first lockstitch pattern 425. In this state, the second lockstitch pattern 427 is allowed some movement in either direction along the run direction 435 of the second lockstitch pattern 427. This midpoint position may be an initial position of the second lockstitch pattern 427, for example, when there are no pulling / stretching forces placed on the substrate.

[0066] FIGS. 4C and 4D show the intersection region after a stretching force is applied to the substrate, thereby causing the second lockstitch pattern 427 to shift toward and be stopped by the lockstitch 432b of the first lockstitch pattern 425. Likewise, FIGS. 4E and 4F show the intersection region after a different stretching force is applied to the substrate, thereby causing the second lockstitch pattern 427 to shift toward and be stopped by the lockstitch 432a of the first lockstitch pattern 425. In this way, movement of the second lockstitch pattern 427 along its run direction 435 is more limited compared to the movement of the first lockstitch pattern 425 along its run direction 430. This results in more compliance of the substrate / graft along the run direction 430 compared to the run direction 435. Further differentiate compliance may be provided when a third lockstitch pattern (not shown) is embroidered into the substrate to form a corner lock pattern with one of the lockstitch patterns 425 or 427.

[0067] FIG. 5 is a schematic of one example of a method for forming a compliance control pattern in a substrate, for example, to form a surgical graft. A substrate stabilizingpattern may be formed in the substrate 502. The substrate may be a porous, thin, stretchy, or otherwise unable to sufficiently support embroidery of a structural pattern (e.g., a compliance control pattern). The substrate stabilizing pattern may include a lockstitch pattern. In some examples, the substrate stabilizing pattern may be arranged in a series of parallel lines. The lines may be spaced apart by a predetermined distance for anchoring vertices of the subsequently formed corner lock pattern. For example, the substrate stabilizing pattern may be configured to provide support for vertices of a corner lock pattern.

[0068] The shape of the substrate stabilizing pattern may be generally straight lines, which it may be possible to include in even the most delicate substates. In some cases the stabilizing pattern (e.g., the substate-stabilizing lengths of filament sewn into the substrate) are not limited to straight lines that are arranged in parallel and equidistantly spaced apart (e.g., as in the example of FIGS. 3B-3D). For example, the substrate stabilizing pattern may include a series of non-parallel lines, lines that are distanced apart by different distances, curved lines, polygonal shapes, round shapes, elliptical shapes, irregular shapes, and / or individual stitches.

[0069] Once the stabilizing pattern is applied to the substrate, the structural pattern may be applied 503. The stabilizing pattern may include a variety of bent, angled or curved embroidered runs that may overlap and may provide mechanical support (e.g., compliance support) to the graft. In some cases the stabilizing pattern may be a comer lock pattern. For example, in FIG. 5, a first lockstitch pattern of a corner lock pattern may be formed in the substrate 504. The first lockstitch pattern may include a series of vertices. In some examples, the first lockstitch pattern includes a zigzag pattern. The first lockstitch pattern may be stitched over and intersect with the substrate stabilizing pattern such that the substrate stabilizing pattern anchors one or more vertices of the first lockstitch pattern. When the vertices are anchored, they are sufficiently positioned for forming a corner lock pattern with a subsequently embroidered second lockstitch pattern. The first lockstitch pattern may envelop the substrate stabilizing pattern where the two intersect. That is, the upper thread of the first lockstitch pattern may overlay the upper thread of the substrate stabilizing pattern, and the lower thread the first lockstitch pattern may overlay the lower thread of the substrate stabilizing pattern.

[0070] At step 506, a second lockstitch pattern may be formed in the substrate to complete the corner lock pattern. The second lockstitch pattern may include a series of vertices corresponding to the series of vertices of the first lockstitch pattern. In some examples, both the first and second lockstitch patterns have a zigzag pattern. The second lockstitch pattern may be stitched over and intersect with the substrate stabilizing patternsuch that the substrate stabilizing pattern anchors one or more vertices of the second lockstitch pattern. The second lockstitch pattern may envelop the substrate stabilizing pattern where the two intersect. That is, the upper thread of the second lockstitch pattern may overlay the upper thread of the substrate stabilizing pattern, and the lower thread the second lockstitch pattern may overlay the lower thread of the substrate stabilizing pattern.

[0071] The substrates described herein may include biocompatible materials such as biotextiles. The biotextiles may be obtained or derived from living tissue. In some cases, the biotextiles include an extracellular matrix. Living tissue may include, for example dermis / skin tissue (and sub-tissue, extracellular matrices), pericardium, peritoneum, intestine, stomach, forestomach, and other suitable tissues. The animal source may be any suitable animal, including a mammal such as human, pig, cow, or sheep, or may be synthesized, for example, by recombinant expression. Biotextiles may be biodegradable or resorbable. Some non-limiting examples of biotextiles include extracellular matrix-derived tissue scaffolds or patches, autograft tissue, allograft tissue, and xenograft tissue, as well as artificial skin, artificial heart valves, and other implantable prosthetics.

[0072] The substrates described herein may include medical textiles made of one or more synthetic materials. Some non-limiting examples of synthetic materials may include polypropylene, polyethylene, as well as combinations of polypropylene and polyethylene, and / or other implantable polymers. Substrates comprising polypropylene may be preferred in some cases. Substrates comprising polyethylene, including polyethylene monofilaments may be preferred in some cases.

[0073] The substrates described herein may include a collagen sheet, a hyaluronic acid sheet, a knit, a weave, a braid, a nonwoven material, a meltblown material, an electrospun sheet, a biotextile material and / or a latex material.

[0074] The substrates described herein may comprise a film. The film may comprise one or more layers (e.g., placed on the outer surfaces) of the substrate, or the film may constitute the entire substrate. Support stitch patterns and / or compliance control stitch patterns may be sewn or embroidered into one or more layers of the film.

[0075] The substrates described herein may include one layer of material or multiple layers of material. The layers may be made of the same material or different materials. If multiple layers are used, the embroidery (e.g., substrate stabilizing pattern and / or comer lock pattern) may be sewn through all or a subset of the layers.

[0076] The filament (e.g., yarn, thread, etc.) described herein may be made of one or more biocompatible materials. The filament may include one fiber (e.g., monofilament) or multiple fibers. The filament may be made of one material or multiple materials. The filamentmay be made of one or more synthetic materials and / or one or more materials obtained or derived from living tissue. In some examples, the filament includes one or more polymer materials, such as polypropylene and / or polyethylene.

[0077] In some examples, the filament and / or the substrate may include one or more biodegradable and / or resorbable materials. The biodegradable and / or resorbable material(s) may degrade and / or be resorbed by the body in a desired period of time, for example, after a sufficient amount of healing. In some examples, the filament and / or the substrate may include different biodegradable and / or resorbable materials that are configured to degrade and / or be resorbed at different rates. In some examples, the filament and / or the substrate includes a combination of biodegradable and / or resorbable materials and material(s) that are not configured to degrade and / or be resorbed.

[0078] The grafts described herein may include any number of support stitch patterns and compliance control stitch patterns. For example, a substrate may include one, two, three, four, five, six, or more support stitch patterns and / or one, two, three, four, five, six, or more compliance control stitching patterns. In some examples, the support stitch patterns are part of the compliance control stitch pattern.

[0079] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0080] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features,steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.

[0081] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “undef ’ can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0082] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0083] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0084] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0085] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word“about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0086] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0087] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of thisdisclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. A surgical graft, the graft comprising: a substrate; a plurality of adjacent rows of substrate-stabilizing lengths of filament sewn into the substrate; and a structural pattern comprising a left-and-right alternating lockstitch pattern of one or more lengths of filaments sewn into the substrate forming a plurality of alternating left and right vertices, wherein each left vertex is positioned on opposite sides of two or more adjacent rows of the substrate-stabilizing lengths of filaments as compared to a next right vertex in the sequence; wherein the substate comprises either or both: a tear strength that is 300 milliNewtons (mN) or less and / or an average pore diameter that is greater than a stitch length of the left-and-right alternating pattern of lockstitched lengths of filaments.

2. The surgical graft of claim 1, wherein the structural pattern comprises a corner lock pattern wherein at least some of the left vertices interlock with right vertices.

3. The surgical graft of claim 1, further comprising a second plurality of adjacent rows of substrate-stabilizing lengths of filament sewn into the substrate.

4. The surgical graft of claim 2, wherein the second plurality of adjacent rows are perpendicular to the first plurality of adjacent rows.

5. The surgical graft of claim 1, wherein the adjacent rows of substrate-stabilizing lengths of filament sewn into the substrate are lockstitched lengths of filament sewn into the substrate.

6. The surgical graft of claim 1, wherein the structural pattern is configured to form a corner lock pattern wherein at least some of the left vertices overlap with right vertices of an adjacent length of the left-and-right alternating lockstitched pattern.

7. The surgical graft of claim 1, wherein the substrate comprises a mesh.

8. The surgical graft of claim 1, wherein the substrate comprises a sacrificial layer having tear strength that is 300 milliNewtons (mN) or less when implanted into a body.

9. The surgical graft of claim 1, wherein the left-and-right alternating lockstitched pattern comprises a zig-zag pattern.

10. The surgical graft of claim 1, wherein the left-and-right alternating lockstitched pattern comprises a sinusoidal pattern.

11. A surgical graft, the graft comprising: a substrate; a plurality of adjacent rows of substrate-stabilizing lengths of filament sewn into the substrate; and a structural pattern configured as a corner lock pattern comprising a left-and-right alternating lockstitch pattern of lengths of filaments sewn into the substrate forming a sequence of alternating left and right vertices, wherein each left vertex is positioned on an opposite side of two or more adjacent rows of the substratestabilizing lengths of filaments as compared to a next right vertex in the sequence, further wherein a plurality of the left and right vertices interlock; wherein the sub state comprises either or both: a tear strength that is 300 milliNewtons (mN) or less and / or an average pore diameter that is greater than a stitch length of the left-and-right alternating pattern of lockstitched lengths of filaments.

12. A surgical graft comprising: a substrate; a substrate-stabilizing pattern comprising one or more lengths of filament sewn into the substrate; and a comer lock pattern sewn into the substrate over the substrate-stabilizing pattern, wherein the corner lock pattern comprises: a first lockstitch pattern that includes a series of first vertices; and a second lockstitch pattern that includes a series of second vertices that interlock with the series of first vertices of the first lockstitch pattern to form a plurality of corner locks, wherein the first and second lockstitch patterns intersect the substratestabilizing pattern such that a vertex of the first lockstitch pattern is on a first side of the substrate-stabilizing pattern and a vertex of the second lockstitch pattern is on a second side of the substrate-stabilizing pattern to anchor the series of first and second vertices.

13. The surgical graft of claim 12, wherein the substrate-stabilizing pattern comprises a plurality of adjacent rows of lengths of filament sewn into the substrate.

14. The surgical graft of claim 13, wherein the plurality of adjacent rows are arranged in parallel.

15. The surgical graft of claim 12, wherein threads of the second lockstitch pattern intersect and envelope threads of the first lockstitch pattern.

16. The surgical graft of claim 12, wherein first vertices of the series of first vertices are equidistantly spaced apart, and wherein second vertices of the series of second vertices are equidistantly spaced apart.

17. The surgical graft of claim 12, wherein each of the first and second lockstitch patterns is a zigzag pattern.

18. The surgical graft of claim 12, wherein the substrate comprises a porous material having an average pore diameter that is greater than a stitch length of the first or second lockstitch pattern.

19. The surgical graft of claim 18, wherein the porous material is a mesh, a foam, or a stretchy film.

20. The surgical graft of claim 12, wherein the substrate comprises a material having a tear strength that is 300 milliNewtons (mN) or less.

21. The surgical graft of claim 12, wherein the substrate comprises a sacrificial layer.

22. The surgical graft of claim 12, wherein the substrate includes a thin or delicate sheet of material.

23. The surgical graft of claim 12, wherein the substrate includes one or more of a collagen sheet, a hyaluronic acid sheet, a knit, a weave, a braid, a nonwoven material, a meltblown material, an electrospun sheet, a biotextile material and a latex material.

24. The surgical graft of claim 12, wherein the surgical graft is a hernia repair graft or a breast reconstruction graft.

25. A method of forming a surgical graft, the method comprising:sewing a substrate-stabilizing pattern in a substrate, wherein the substrate-stabilizing pattern comprises a plurality of adjacent rows; and sewing a structural pattern in the substrate comprising a left-and-right alternating lockstitch pattern forming a sequence of alternating left and right vertices, wherein each left vertex is positioned on an opposite side of two or more adjacent rows of the substrate-stabilizing pattern as compared to a next right vertex in the sequence; wherein the substrate is formed of a material having a tear strength when implanted into a body that is 300 milliNewtons (mN) or less and / or an average pore diameter that is greater than a stitch length of the left-and-right alternating pattern of lockstitch lengths of filaments.

26. The method of claim 25, wherein sewing the substrate-stabilizing pattern comprises sewing a plurality of parallel adjacent rows.

27. The method of claim 25, wherein the structural pattern comprises a corner lockstitch pattern in which a plurality of the left and right vertices interlock with each other.

28. The method of claim 25, wherein the left and right vertices are equidistantly spaced apart.

29. The method of claim 25, wherein the structural patterns comprises a zigzag or sinusoidal pattern.

30. The method of claim 25, further comprising removing substrate.

31. A method for repairing or reconstructing soft tissue in the body of a subject in need thereof, the method comprising implanting any of the surgical grafts of any of claims 1- 24, at a location in need of soft tissue repair or reconstruction.

32. The method of claim 31, wherein the location comprises a hernia.

33. The method of claim 31, wherein the location comprises a breast.

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