Mesh and its uses

Abstract

Lightweight reinforced meshes, such as surgical meshes, suitable for use in a variety of applications, including breast reconstruction, cosmetic breast surgery, mastopexy, breast augmentation, breast reduction, soft tissue reconstruction, hernia repair, tissue plication reinforcement, tissue support and repair, tendon support and repair, tissue engineering, and procedures or other applications requiring additional soft tissue strength or thickness. Additionally, the use of such meshes for tissue engineering, regardless of surgical application, is disclosed. In particular, the present disclosure relates to surgical meshes that can provide reinforced support while maintaining the characteristics of flexibility, low density, and absorbency. Additionally, the present disclosure focuses on reducing the material burden of the scaffold while increasing porosity to facilitate tissue ingrowth.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 155,112, filed March 1, 2021, and U.S. Provisional Patent Application No. 63 / 225,495, filed July 24, 2021, both of which are incorporated by reference in their entirety into this specification for all purposes.

[0002]

[0002] The present disclosure relates to meshes (e.g., surgical meshes) for various applications including surgical implantation and tissue engineering. In particular, the present disclosure relates in some aspects to the structure, manufacture, and use of lightweight, reinforced surgical meshes formed from multiple layers with passageways therebetween. [Background technology]

[0003]

[0003] Absorbable meshes are beneficial for use in surgical procedures when tissue support and tissue guidance are desired. Potential benefits for certain types of absorbable meshes include their lightweight and flexible characteristics, as well as their ability to blend into the patient's own tissue over time. The density of the absorbable mesh also allows tissue to grow through and around the mesh as it is absorbed, ultimately replacing the support provided by the mesh with the body's own tissue.

[0004]

[0004] However, in some procedures, such as breast reconstruction, extended structural support with increased volume and space may be desirable or necessary while maintaining the benefits of absorbable mesh as described above. Unfortunately, conventional means of adding structural support to absorbable mesh require thickening and / or adding multiple layers of mesh fibers in a three-dimensional fashion. Although such methods provide structural support, they result in a loss of flexibility. These methods also result in increased mesh density, which may lead to increased risks of seroma formation, infection, and / or lack of tissue support upon mesh absorption. Summary of the Invention

[0005] In some aspects, meshes are disclosed, such as lightweight reinforced surgical meshes, suitable for use in a variety of applications, including breast reconstruction, cosmetic breast surgery, mastopexy, breast augmentation, breast reduction, soft tissue reconstruction, hernia repair, tissue plication enhancement, tissue support and repair, tendon support and repair, tissue engineering, and procedures or other applications that benefit from additional soft tissue strength or thickness. In some aspects, the use of such meshes for tissue engineering, regardless of surgical application, is disclosed. In some aspects, meshes, such as surgical meshes, are disclosed that can provide reinforced support while maintaining the characteristics of flexibility, low density, and absorbency. In some aspects, the present disclosure relates to minimizing the material burden of the mesh while increasing porosity to best facilitate tissue ingrowth.

[0006]

[0006] A mesh is disclosed comprising a first layer having a first plurality of channel openings, a second layer having a second plurality of channel openings, and at least one structure disposed between the first layer and the second layer to form a volume therebetween, the volume comprising channels and internal passages.

[0007]

[0007] Also disclosed is a mesh comprising a foam sheet having corrugations, the foam sheet extending along a plane, and at least one of (a) yarn(s), (b) adhesive, (c) molten polymer, and a first layer attached to the peaks of the corrugations of the foam sheet, integrated with the foam sheet to maintain the corrugations, wherein the corrugations of the foam sheet define a volume extending along the plane, the volume comprising channels and internal passages, and when present, the first layer having a first plurality of channel openings.

[0008]

[0008] Additionally, a method of manufacturing a mesh is disclosed, the method including knitting a first layer using a twin needle warp knitter, knitting a second layer using a twin needle warp knitter, and optionally attaching the first layer to the second layer by knitting at least one structure using the twin needle warp knitter.

[0009]

[0009] Further disclosed is a method that includes implanting a mesh into a patient.

[0010]

[0010] The above and other features and advantages of the present disclosure, as well as the manner in which they are achieved, will become more apparent and be better understood by reference to the following description of an embodiment of the present invention taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0011] [Figure 1A] FIG. 1 illustrates a mesh (eg, a surgical mesh) having a honeycomb shaped structure. [Figure 1B]

[0012] FIG. 1B is an enlarged view of the mesh of FIG. 1A. [Figure 2A]

[0013] FIG. 1 is a cross-sectional view of a mesh, for example a surgical mesh, showing a foam sheet of the mesh. [Figure 2B]

[0013] FIG. 1 is a cross-sectional view of a mesh, for example a surgical mesh, showing a foam sheet of the mesh. [Figure 2C]

[0013] FIG. 1 is a cross-sectional view of a mesh, for example a surgical mesh, showing a foam sheet of the mesh. [Figure 2D]

[0014] FIG. 2C shows a mesh similar to that of FIG. 2B but with a thicker profile. [Figure 2E] FIG. 2C shows a mesh similar to that of FIG. 2B but with a thinner profile. [Figure 3A]

[0015] FIG. 1 illustrates a stitch pattern for a mesh (eg, surgical mesh). [Figure 3B]

[0016] FIG. 3B is an enlarged view of the stitch pattern of FIG. 3A. [Figure 4A]

[0017] FIG. 1 illustrates another stitch pattern for a mesh (e.g., surgical mesh). [Figure 4B]

[0018] FIG. 4B is an enlarged view of the stitch pattern of FIG. 4A. [Figure 5A]

[0019] FIG. 13 illustrates yet another stitch pattern for a mesh (e.g., surgical mesh). [Figure 5B]

[0020] FIG. 5B is an enlarged view of the stitch pattern of FIG. 5A. [Figure 6A]

[0021] 13A-13C illustrate additional stitch patterns for mesh (e.g., surgical mesh). [Figure 6B]

[0022] FIG. 6B is an enlarged view of the stitch pattern of FIG. 6A. [Figure 7A]

[0023] FIG. 1 is an enlarged top view showing a first cross-layer stitch pattern for a mesh (e.g., surgical mesh) using a single pile bar. [Figure 7B]

[0024] FIG. 7B is a cross-sectional view showing the cross-layer stitch pattern of FIG. 7A. [Figure 7C]

[0025] FIG. 7B is an enlarged top view of the first cross-layer stitch pattern of FIG. 7A using a double pile bar. [Figure 7D]

[0026] FIG. 7D is a cross-sectional view showing the stitch pattern of FIG. 7C. [Figure 8A]

[0027] FIG. 13 is an enlarged top view showing a second cross-layer stitch pattern for a mesh (e.g., surgical mesh) using a single pile bar. [Figure 8B]

[0028] FIG. 8B is a cross-sectional view showing the cross-layer stitch pattern of FIG. 8A. [Figure 8C]

[0029] FIG. 8B is an enlarged top view of the second cross-layer stitch pattern of FIG. 8A using a double pile bar. [Figure 8D]

[0030] FIG. 8D is a cross-sectional view showing the stitch pattern of FIG. 8C. [Figure 9A]

[0031] FIG. 13 is an enlarged top view showing a third cross-layer stitch pattern for a mesh (e.g., surgical mesh) using a single pile bar. [Figure 9B]

[0032] FIG. 9B is a cross-sectional view showing the cross-layer stitch pattern of FIG. 9A. [Figure 9C]

[0033] FIG. 9B is an enlarged top view of the third cross-layer stitch pattern of FIG. 9A using a double pile bar. [Figure 9D]

[0034] FIG. 9D is a cross-sectional view showing the stitch pattern of FIG. 9C. [Figure 10]

[0035] FIG. 1 is a cross-sectional view showing a mesh with five layers and five foam sheets in an alternating arrangement. [Figure 11]

[0036] FIG. 1 is a perspective view showing a circular or elliptical mesh with five layers and five foam sheets in an alternating arrangement. [Figure 12A]

[0037] FIG. 1 is a perspective view showing a rectangular mesh with two layers and two foam sheets in an alternating arrangement. [Figure 12B]

[0038] FIG. 12B is an enlarged view of the mesh of FIG. 12A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012]

[0039] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate exemplary embodiments of the present invention, and such exemplifications should not be construed as limiting the scope of the present invention in any manner.

[0013]

[0040] In order to promote an understanding of the principles of the present invention, reference will now be made to the embodiments shown in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the present invention is intended herein. Any changes and further modifications in the described embodiments, as well as any further applications of the principles of the present invention described herein, will be expected to occur normally to those skilled in the art to which the present invention pertains. Although certain embodiments of the present invention have been shown in great detail, it will be apparent to those skilled in the relevant art that some features not relevant to the present invention may not be shown for the sake of clarity.

[0014]

[0041] As used herein, "stitch pattern" means a pattern of sewing, knitting, and / or weaving threads that results in a recognizable pattern upon visual inspection. Stitch pattern may also refer to a pattern for woven materials. The pattern refers to the resulting construction after specific movements of the knitting and weaving processes. Examples of stitch patterns are shown in Figures 1 and 3-9.

[0015]

[0042] As used herein, a stitch pattern (e.g., a first stitch pattern) that is "substantially the same" as another stitch pattern (e.g., a second stitch pattern) means that the two stitch patterns are sufficiently similar that they would be considered to be substantially the same stitch pattern by one skilled in the art of manufacturing surgical meshes.

[0016]

[0043] As used herein, a "channel" refers to the shortest direct path between one surface of a mesh and the opposite surface of the mesh that allows fluids, cells, blood vessels, and / or tissues to enter and exit the interior volume of the mesh. Channels may be uniform throughout their length or may be non-uniform throughout their length (e.g., narrowing or widening along their length or having a different shape than the channel openings) depending on, for example, the structure of the cross-layer stitch. A channel connects channel openings on two surfaces of a mesh. In general, a channel is the largest path in a mesh that connects two surfaces of the mesh.

[0017]

[0044] As used herein, a "channel opening" is an opening in the two-dimensional plane of a mesh that is an entrance to a channel. A channel opening can have any suitable shape, such as a honeycomb shape or other shape, when characterized by viewing the mesh perpendicular to the plane in which it lies. Generally, a channel opening is the largest opening in the two-dimensional plane of a mesh, and thus a channel opening is contrasted with other, generally smaller openings (e.g., "small pores") in the plane of the mesh that may exist due to gaps inherent in the intertwining nature of the materials that make up the scaffold (e.g., yarn or twist). See, for example, FIG. 4B, which shows channel opening 400, channel 402, and small pore 404. As the mesh becomes thinner, channel opening and channel are synonymous in a two-dimensional mesh.

[0018]

[0045] As used herein, "internal passage" means a path within the plane of the mesh (i.e., between two faces of the mesh) that allows for the movement of fluids, cells, vessels, and / or tissue in the interior volume of the mesh. An internal passage generally fluidly connects two or more channels.

[0019]

[0046] As used herein, the "average diameter" of a channel, channel opening, or pore is determined as follows: the diameter of the largest circle that can be stretched within the channel, channel opening, or pore is measured; a representative portion of such channel, channel opening, or pore is measured, and the average diameter is calculated from this representative portion.

[0020]

[0047] As used herein, "macroporous structure" refers to one or more systems of channels, channel openings, internal passages, and small pores present in the mesh. Typically, the mesh comprises each of the openings, channel openings, channels, internal passages, and small pores, and thus the macroporous structure includes all of these features. However, in some embodiments, certain features such as small pores may not be present, and thus in such cases the macroporous structure will only include channel openings, channels, and internal passages. In some embodiments, the porous structure provides a mesh with various properties, such as low density, fluid absorption capacity, structural integrity, or any combination thereof. Generally, multiple channel openings on the surface of the mesh are connected through the interior of the mesh via channels. In some embodiments, the channels are connected within the interior (e.g., volume) of the mesh by internal passages. In some embodiments, the small pores also provide a route to and from the interior, or at least a location for fluids, compounds, and / or cells to adhere to the mesh.

[0021]

[0048] As used herein, "density" with respect to a layer, such as a knitted or woven layer, means the percentage of the two-dimensional area of ​​the layer that is occupied by material (e.g., yarn, fabric, and / or other material) relative to the total two-dimensional area of ​​the layer. Density can be calculated by imaging the layer and calculating the two-dimensional area occupied by the material divided by the total two-dimensional area of ​​the layer. Density is sometimes determined in the art by counting the number of yarns that cross in the machine and in the machine direction, but this method is affected by the yarn size and stitch pattern, and therefore is not ideal or uniformly applicable when attempting to compare different structures.

[0022]

[0049] As used herein, "mesh porosity" with respect to a mesh (e.g., a surgical mesh) refers to the void ratio within the volume of the mesh. Such mesh porosity is calculated according to the following formula:

[0023]

number

[0024] In the above formula, P is the mesh porosity and M is the mass per unit area of ​​the mesh (g / m 2 ), h is the thickness of the mesh in the direction perpendicular to the mesh surface (mm), and ρ is the relative density (g / m2) of the material (e.g., yarn, polymer, fabric, etc.) that composes the mesh. 3 ).

[0025]

[0050] As used herein, a density (e.g., a first density) that is "substantially the same as" another density (e.g., a second density) means that the two densities are within 10-30% of each other.

[0026]

[0051] As used herein, "absorbable" and "resorbable" are used interchangeably and are not intended to have different meanings unless clearly indicated by the context. "Absorbable" and "resorbable" refer to the chemical transformation of the mesh over a specified (specified elsewhere herein) period of time under physiological conditions (i.e., without the aid of external aids such as sonication, drugs, palpation, or surgery). Various degrees of absorbability or resorption exist. For example, a mesh that is "completely" resorbed within six months means that by six months, the mesh is no longer present at the implantation site.

[0027]

[0052] As used herein, a "wave" in reference to a foam sheet means a shape having a repeating series of peaks and valleys, such as a sinusoidal shape. A wave can have smooth curvatures between the peaks and valleys, non-smooth curvatures such as rectangular or triangular, or a combination of both smooth curvatures for some peaks / valleys and non-smooth curvatures for other peaks / valleys. For example, a wave can include a combination of smooth curvatures in one portion of the foam sheet and a box shape in another portion of the foam sheet. An example of a "wave" is shown as feature 208 in Figures 2A, 2B, and 2C.

[0028]

[0053] As used herein, "mesh" and "scaffold" are used interchangeably and are not intended to have different meanings unless clearly indicated by context.

[0029]

[0054] As used herein, the term "volume" is generally intended to include both open space (e.g., voids) and any structures (i.e., materials such as foam sheets or threads) that exist within a given volume, if any. For example, in embodiments when a mesh has a first layer, a second layer, and a structure disposed between the first and second layers to form a volume therebetween, the volume generally includes any open space (e.g., voids) as well as any structures that exist within the volume between the first and second layers.

[0030]

[0055] In some embodiments, a mesh is disclosed that comprises a first layer (e.g., a first knitted and / or woven layer) having a first plurality of channel openings, a second layer (e.g., a second knitted and / or woven layer) having a second plurality of channel openings, and at least one structure disposed between the first layer and the second layer to form a volume therebetween, the volume comprising channels and internal passages.

[0031]

[0056] In some embodiments, a mesh is disclosed that includes a foam sheet having corrugations, the foam sheet extending along a plane, and at least one of a thread(s), an adhesive, a molten polymer, and a first layer (e.g., a first knitted and / or woven layer) attached to the crests of the corrugations of the foam sheet, the corrugations of the foam sheet defining a volume extending along a plane, the volume comprising channels and internal passages, and when present, the first layer having a first plurality of channel openings. In some embodiments, the first layer further comprises a first density and / or a first stitch pattern. In some embodiments, the mesh further comprises a second layer (e.g., a second knitted and / or woven layer) having a second plurality of channel openings. In some embodiments, the second layer further comprises a second density and / or a second stitch pattern. In some embodiments, the thread(s) is present. In some embodiments, the adhesive is present. In some embodiments, the molten polymer is present. In some embodiments, the first layer is present. In some embodiments, a second layer is present, and such second layer can have a second plurality of channel openings. In some embodiments, any combination of thread(s), adhesive, molten polymer, and first layer is present. In some embodiments, the first layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer. In some embodiments, the second layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer. In some embodiments, a first layer is present, and (a) the first layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer, (b) the second layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer, or (c) the first layer and the second layer are knitted layers, woven layers, or both a knitted layer and a woven layer.

[0032]

[0057] In some embodiments, a mesh having a low density is disclosed. In some embodiments, the scaffold comprises ultra-fine fibers that form an initial mesh and are then woven into a honeycomb type configuration (or other shapes as disclosed elsewhere herein) with a geometry that allows the amount of material used to be reduced to reach a low weight, as shown in FIG. 1A. The volume or space promoting structure can have a sinusoidal or similar type of corrugated sheet that is held in place by connecting threads (see, e.g., FIG. 2C). Additionally or alternatively, in some embodiments, the corrugations of the corrugated sheet can be held in place by a top layer (e.g., a first layer, such as a first knitted and / or woven layer), or a combination of top and bottom layers (e.g., a second layer, such as a second knitted and / or woven layer) (see, e.g., FIG. 2A and FIG. 2B). In some embodiments, the corrugated sheet provides structural strength at a low weight (i.e., strong and lightweight). In some embodiments, the honeycomb woven mesh structure (or other shapes disclosed elsewhere herein) provides low density and structural support to allow for the creation of a shaped mesh, in this regard the micro- and macro-weaves act symbiotically. In some embodiments, the mesh may exhibit piezoelectric properties such that when the mesh is partially compressed, an expansion force is created on the mesh, this tension in some embodiments generating piezoelectric currents, such currents being seen to stimulate cellular ingrowth and therefore desirable in certain applications.

[0033]

[0058] FIG. 1A shows a mesh or scaffold 100, which can be used, for example, as a reinforced absorbable surgical mesh. FIG. 1B is an enlarged view of a portion of FIG. 1A. The scaffold 100 has a hexagonal shape and includes a plurality of channel openings 102 that provide a honeycomb shaped structure throughout the scaffold 100. The channel openings 102 on each side are connected by channels 112 that run through the interior of the scaffold. Although not necessarily clearly discernible from FIG. 1A or FIG. 1B, the scaffold 100 includes a first layer (e.g., a first knitted and / or woven layer), a second layer (e.g., a second knitted and / or woven layer), and at least one structure disposed between the first and second layers. In this case, the at least one structure includes a foam sheet held in place by connecting yarns 110.

[0034]

[0059] In some embodiments, the plurality of channel openings 102 may additionally or alternatively define any other shaped structure, such as polygonal structures, circular structures, elliptical structures, star-shaped structures, or any combination thereof. For example, in some embodiments, both hexagonal and circular structures are present, and in other embodiments, both hexagonal and diamond-shaped structures are present. In some embodiments, the polygonal structures may include triangular structures, square structures, rhombus structures, diamond structures, pentagonal structures, heptagonal structures, octagonal structures, or any combination thereof. In some embodiments, any other shape may be used if desired.

[0035]

[0060] In some embodiments, the macroporous structure of the scaffold, including the channels 112 in combination with the internal passages and / or small pores, is sponge-like and facilitates adsorption and / or absorption of fluids, cells, and / or other compounds. In some embodiments, bioactive fluids can be added to the scaffold to stimulate tissue ingrowth. In some embodiments, the macroporous structure of the scaffold facilitates tissue ingrowth when implanted within a patient to create a desired, native tissue support as the scaffold adsorbs and / or absorbs fluids, cells, bioactive fluids, compounds, or any combination thereof. Examples of fluids, cells, bioactive fluids, or compounds include, for example, adipose tissue, platelet rich plasma (PRP), hyaluronic acid, lipoaspirate stromal vascular fraction, compounds including xenogeneic cells from the patient, regenerative or therapeutic agents (e.g., to facilitate treatment, cell ingrowth, and / or cell repair), or any combination thereof.

[0036]

[0061] In some embodiments, hyaluronic acid is particularly useful for promoting tissue ingrowth. For example, when hyaluronic acid (or a similar fluid or compound) is added to the scaffold, it can stimulate cell migration into the fluid-containing space. These cells, which can be fibroblasts, deposit collagen, thereby facilitating cell ingrowth. In some embodiments, growth factors other than hyaluronic acid can additionally or alternatively be added to the scaffold. In some embodiments, a compound or fluid of interest (e.g., hyaluronic acid) can be coated onto and / or injected into the scaffold, which can then be used as is in the desired application (e.g., surgery or tissue engineering). Alternatively, the coated / injected scaffold can be first dried and used as is in the desired application, such as in situations where the dried scaffold will not adversely affect the desired application. However, in other embodiments, the dried scaffold is rehydrated in sterile water prior to use in the desired application. In such embodiments, hydration allows compounds of interest, particularly hydrophilic compounds such as hyaluronic acid, to fill the channels and other interior spaces of the scaffold.

[0037]

[0062] In some embodiments, the scaffold has channels and channel openings of any suitable average diameter. In general, the particular average diameter of the channel openings and / or channels allows for various physical and physiological phenomena. For example, channels and / or channel openings having an average diameter of less than 100 microns typically allow only single cell migration, an average diameter of less than 200 microns typically impairs fluid movement at physiological pressures, an average diameter of less than 200-300 microns typically impairs angiogenesis, and an average diameter of less than 500-600 microns impairs soft tissue ingrowth and uptake. Thus, the average diameter of the channels and / or channel openings can be selected in light of the desired application. In some embodiments, the channels and / or channel openings (e.g., a plurality of channel openings) may be 10-100, 10-200, 10-300, 10-400, 10-500, 10-600, 10-700, 10-800, 10-900, 10-1000, 100-200, 100-300, 100-400, 100-500, 10 The average diameter (μm) may be 0 to 600, 100 to 700, 200 to 300, 200 to 400, 200 to 500, 200 to 600, 200 to 700, 300 to 400, 300 to 500, 300 to 600, 300 to 700, 400 to 500, 400 to 600, 400 to 700, 500 to 600, or 500 to 700. The average diameter can also be expressed for certain larger channel and / or channel opening sizes, including an average diameter (mm) of 0.8 to 3, 1 to 3, 1 to 2.8, 1 to 2.6, 1 to 2.4, 1 to 2.2, 1 to 2, 1 to 1.8, 1 to 1.6, 1 to 1.4, 1 to 1.2, 1.2 to 3, 1.4 to 3, 1.6 to 3, 1.8 to 3, 2 to 3, 2.2 to 3, 2.4 to 3, 2.6 to 3, 2.8 to 3, 1.2 to 2.8, 1.4 to 2.6, 1.6 to 2.4, or 1.8 to 2.2. The small pores generally have a size smaller than the channel openings and / or channels, such as a small pore average diameter (μm) of 1-500, 1-400, 1-300, 1-200, 1-100, 1-75, 1-50, 1-25, 10-500, 10-400, 10-200, 10-100, 50-500, 50-400, 50-200, or 50-100.In some embodiments, the average diameter of the channel openings and / or channels is about 100 microns, about 200 microns, about 300 microns, about 400 microns, about 500 microns, about 600 microns, about 700 microns, about 800 microns, about 900 microns, about 1000 microns, about 1100 microns, about 1200 microns, about 1300 microns, about 1400 microns, about 1500 microns, about 1600 microns, about 1700 microns, about 1800 microns, about 1900 microns, or about 2000 microns, or any range that can be derived. For clarity, any of the aforementioned numbers apply to the average diameter of the channel openings, the average diameter of the channels, or both. In some embodiments, at least one of the first plurality of channel openings (in the first layer), the second plurality of channel openings (in the second layer), and the channels has an average diameter of at least 800 microns, or any of the other average diameters or ranges thereof described herein.

[0038]

[0063] In some embodiments, the scaffold is composed of yarns. In some embodiments, the yarns comprise monofilament fiber yarns, multifilament fiber yarns, or combinations thereof. In some embodiments, the yarns comprise polymers, copolymers, or combinations thereof. In some embodiments, the yarns are absorbable and / or resorbable. In some embodiments, the yarns may be equivalent to USP 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, or 1-0, or any combination thereof. Smaller diameter fibers such as 6-0 and 5-0 can be used to elicit lower macrophage numbers and / or smaller overall diameters of associated inflammatory infiltrates compared to larger diameter fibers, and thus may be desirable under certain circumstances that would benefit from such properties. In some embodiments, such properties have positive implications for tissue ingrowth and long-term strength. On the other hand, larger inner diameter fibers are generally stronger, which has implications for the short-term strength of the scaffold during the period after implantation and prior to tissue ingrowth.

[0039]

[0064] In some embodiments, suitable polymers comprising the scaffold may include, for example, polydioxanone, poly-4-hydroxybutanoic acid, polylactic acid, polyglycolic acid, polycaprolactone, trimethylene carbonate, any copolymers thereof, or any combination thereof. Other suitable polymers may be used as known in the art. In some embodiments, the polymer and / or copolymer strands used in the manufacture of the scaffold are woven and / or warp knit in a stitch pattern that creates the channel opening geometry and / or channel geometry, as described elsewhere herein.

[0040]

[0065] The choice of polymer used in forming the scaffold can affect the effective porosity, effective channel diameter, and / or effective channel opening diameter, each of which collectively contribute to the porosity of the mesh. The discussion herein, including the above discussion of the benefits of porosity and channel and / or channel opening size, assumes that these channels and channel openings are not blocked by bridging granulomas or bridging scar tissue, both of which are clinically problematic effects of foreign body reactions such as scaffolds. Bridging of channel openings or clogging of channels is referred to as "encapsulation" rather than "incorporation" and generally excludes neovascularization, tissue ingrowth, fluid flow, and other positive elements of foreign body reactions. Effective porosity is used to describe the porosity (and size of channels or channel openings) when considering bridging granulomas or inflammatory infiltrates (ranging in size from about 80 to about 400 microns) that form around the foreign fibers. The polymer material, degradation by-products, filament size, and other factors modify the effective size of the channel openings and channels within the scaffold. The effective porosity, effective channel opening diameter, and effective channel diameter contribute to the mesh porosity. Each pore can be individually measured by microscopy or metrology techniques.

[0041]

[0066] The selection of polymers used in forming the scaffold can render the resulting structure at least partially resorbable, or in some embodiments, completely resorbable. The scaffold can be fully degraded / resorbed in situ within about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 12 months, about 13 months, about 14 months, about 15 months, about 16 months, about 17 months, or about 18 months, or any range derivable therein, such as 1-18 months, 2-17 months, 3-16 months, 4-15 months, 5-14 months, 6-13 months, 7-12 months, 8-11 months, 9-10 months, 1-12 months, 6-18 months, 1-4 months, 4-8 months, 8-12 months, 12-16 months, or 16-18 months. In some embodiments, the scaffold may completely degrade / resorb within a longer or shorter time period, as desired. In this regard, the timing of degradation / resorption of any embodiment is based not only on the polymer selection and fiber configuration, but also on the fiber inner diameter, number of layers, cross-layer stitch pattern, channel opening average diameter, and channel average diameter. In some embodiments, the scaffold is not resorbable (e.g., permanent), as that term is understood by those skilled in the art of implanting surgical meshes in patients.

[0042]

[0067] 2A and 2B are cross-sectional views showing scaffold 200 (FIGS. 2A and 2B can also represent cross-sectional views of scaffold 100 from FIG. 1A). Scaffold 200 comprises a first layer 204 (e.g., a first knitted and / or woven layer), a second layer 206 (e.g., a second knitted and / or woven layer), and at least one structure 208 disposed between first layer 204 and second layer 206 to form a volume 212, the volume comprising channels (not shown, in the plane of the page, vertically) and internal passages 214. In FIGS. 2A and 2B, at least one structure 208 is a foam sheet having corrugations. In some embodiments, foam sheet 208 can be stitched in place with a connector yarn (see feature 110 in FIGS. 1A and 1B). In other embodiments, the foam sheet 208 may be woven (e.g., stitched) directly into the first layer 204 and / or second layer 206. A mesh similar to that of Figure 2B is shown in Figures 2D and 2E, showing a foam sheet having a thicker (Figure 2D) or thinner (Figure 2E) profile.

[0043]

[0068] While scaffold 200 is shown in FIGS. 2A and 2B as having two layers 204 and 206, it is contemplated that only one layer (204 or 206) may be employed and still result in a satisfactory scaffold. In other embodiments, a greater number of layers may be employed, including three layers, four layers, five layers, six layers, seven layers, eight layers, nine layers, ten layers, or any number of layers configured to perform the functions and capabilities disclosed herein. In embodiments where more than two layers are employed, foam sheets 208 may be interposed between each layer in scaffold 200, or foam sheets 208 may be interposed between every other layer, or between any few layers, as desired. Examples of meshes including multiple layers and multiple foam sheets are shown in FIGS. 10, 11, 12A, and 12B. For clarity, FIG. 12B is an expanded view of circle D in FIG. 12A. FIG. 11 shows a circular or elliptical shape for the mesh, but any other shape may be adopted, such as a square, rectangle, triangle, polygon, or any other desired shape. Similarly, FIG. 12A shows a rectangular shape, but any other shape may be adopted for the mesh, such as a square, circle, ellipse, triangle, polygon, or any other desired shape. FIGS. 10 and 11 show five interleaved layers and five foam sheets. FIGS. 10 and 11 show a sinusoidal shape for the foam sheets, but alternative or additional shapes, such as those shown in FIGS. 2B, 2D, and 2E, can be adopted, as desired. Similarly, FIGS. 12A and 12B show two interleaved layers and two foam sheets, a sinusoidal shape for the foam sheets, but alternative or additional shapes, such as those shown in FIGS. 2B, 2D, and 2E, can be adopted, as desired. Additionally, although in Figures 10, 11, 12A, and 12B the mesh is shown as having a layer terminating one side of the mesh and a foam sheet terminating the other side of the mesh, alternative arrangements are possible, such as terminating both sides with a foam sheet or terminating both sides with a layer.

[0044]

[0069] In some embodiments, the cross-section of the foam sheet 208 can be a sine wave or similar wave shape, such as the shape shown in Figures 2A and 2B. In some embodiments, the foam sheet 208, when viewed in cross-section as in Figures 2A and 2B, can form a "V" shape (e.g., Figure 2B), a "W" shape, an "I" shape, an "X" shape, a "U" shape (e.g., Figure 2A), an "H" shape, an "N" shape, an "M" shape, an "A" shape, an "O" shape, a ladder shape (discussed further with respect to Figures 9C and 9D), or any combination thereof. Selection of the shape of the foam sheet 208 can allow manipulation of the compressibility and thickness of the scaffold 200 as desired depending on the intended use and / or characteristics of the scaffold 200. In some embodiments, at least one structure is a seam as shown in FIGS. 7-9, and the seam can have any suitable shape as determined by viewing a cross-section of the scaffold, including a "V" shape, a "W" shape, an "I" shape, an "X" shape, an "U" shape, an "H" shape, an "N" shape, an "M" shape, an "A" shape, an "O" shape, a ladder shape, or any combination thereof.

[0045]

[0070] In some embodiments, the foam sheet 208 facilitates bonding of the first layer 204 and the second layer 206 and further defines a volume 212 between the first layer 204 and the second layer 206, for example, to facilitate delivery of fluids, cells, bioactive fluids, and / or other regenerative or therapeutic agents. Additionally, the shape of the foam sheet 208 between the first and second layers 204 and 206 affects the number and average diameter of channels and internal passages passing through the interior (i.e., volume) of the scaffold. For example, "X" and "W" shapes result in a greater number of internal passages with smaller spaces (e.g., average diameter) than "V" or "U" shapes, assuming the spaces between the peaks and valleys of the foam sheet corrugations are held equal.

[0046]

[0071] Each of the first layer 204 and the second layer 206 may include a similar channel opening shape / diameter and small pore shape / diameter, resulting in a similar density for the first layer 204 and the second layer 206. In other embodiments, the channel opening shape / diameter and small pore shape / diameter may be different, resulting in a different density. For example, the first layer 204 may have an increased density compared to the second layer 206, or in other embodiments, the second layer 206 may have an increased density compared to the first layer 204. Thus, each of the first layer 204 and the second layer 206 may have a different density in some embodiments (e.g., perhaps resulting from different stitch patterns), and in other embodiments, each of the first layer 204 and the second layer 206 may have a substantially similar density (e.g., perhaps resulting from similar stitch patterns). In some embodiments, the first stitch pattern and the second stitch pattern are different, or in other embodiments, the first stitch pattern and the second stitch pattern are substantially the same. Manipulation of the density and / or stitch pattern of each layer may allow retention of fluids, cells, bioactive fluids, and / or other regenerative and therapeutic agents, i.e., lower density layers may allow anastomosis of both fluids and cellular material such as fat cells, while higher density layers may allow only or primarily fluid flow to retain cellular material long after implantation. In some embodiments, the scaffold comprises at least one of bioactive fluids, regenerative agents, and therapeutic agents, and optionally additional components such as fluids, cells, etc. Manipulation of density may also facilitate identification of layers during implantation, i.e., one of the higher or lower density layers may be intended to directly contact tissue. The layers 204, 206 may be interconnected during fabric formation, for example, via a double needle bar warp knitter, crochet, jacquard loom, dobby loom, or any combination thereof.

[0047]

[0072] In some embodiments, the first layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer. In some embodiments, the second layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer. In some embodiments, both the first layer and the second layer are knitted layers, woven layers, or both a knitted layer and a woven layer. When a layer is "both a first layer and a second layer," it means that at least a portion of the layer is knitted and at least a portion of the layer is woven.

[0048]

[0073] In some embodiments, the macroporous structure of the scaffold allows for infiltration of fluids and / or cells when implanted in a patient. For example, in some embodiments, the macroporous structure comprises a first plurality of channel openings, a second plurality of channel openings, channels, and internal passages.

[0049]

[0074] FIG. 2C illustrates a scaffold 200 comprising a foam sheet 208 having corrugations (sometimes referred to herein as a "corrugated sheet"), where the foam sheet 208 extends along a plane. In FIG. 2C (and also in FIGS. 2A, 2B, 2D, 2E, 7B, 7D, 8B, 8D, 9B, and 9D), the reference plane is horizontal, perpendicular to the page plane. Yarns 210 are integrated with the foam sheet 208 to maintain the corrugations, although additionally or alternatively, other features may be used to maintain the corrugations, such as threads (e.g., by weaving and / or stitching) at different locations, adhesives, molten polymers, or any combination thereof. For example, in some embodiments, additional lines of connecting yarns may be employed, and in some embodiments, the yarns need not span every peak and / or valley of the corrugated sheet. It is contemplated that in some embodiments, the corrugations can be maintained by bonding adjacent peaks of the corrugated sheet 208 to adjacent valleys on opposite sides of the corrugated sheet 208 using an adhesive and / or a meltable polymer (not shown), optionally in combination with a connecting thread. For example, the corrugated sheet 208 can be heat treated to melt the peaks and / or valleys together, or alternatively or additionally, the peaks and / or valleys can be bonded together by the addition of an adhesive or meltable polymer. The corrugations of the foam sheet 208 define a volume 212 extending along the aforementioned plane, the volume comprising channels and internal passages 214, and in some embodiments also comprising channels. Although not shown, in some embodiments, the scaffold of FIG. 2C can also include a first layer (e.g., a first knitted and / or woven layer) disposed on one side of the foam sheet 208 and a second layer (e.g., a second knitted and / or woven layer) disposed on the other side of the foam sheet 208, in either case similar to the arrangement shown in FIG. 2A.

[0050]

[0075] In some embodiments, the scaffold has any suitable specifications disclosed herein. For example, in some embodiments, the scaffold has an overall thickness of about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, or about 4 mm, or any range thereof, such as 0.5-4 mm, 0.5-3.5 mm, 0.5-2.5 mm, 0.5-2 mm, 0.5-1.5 mm, 0.5-1 mm, 1-4 mm, 1-3.5 mm, 1-3 mm, 1-2.5 mm, 1-2 mm, 1-1.5 mm, 1.5-4 mm, 1.5-3.5 mm, 1.5-3 mm, 1.5-2.5 mm, 1.5-2 mm, 2-4 mm, 2-3.5 mm, 2-3 mm, or 2.5-4 mm, 2.5-3.5 mm, 2.5-3 mm, etc.

[0051]

[0076] In some embodiments, the spacing between cross-layer stitches of the scaffold (e.g., the distance between the vertices 709 of each "V" shown in FIG. 7B) can be about 100 microns, about 200 microns, about 300 microns, about 400 microns, about 500 microns, about 600 microns, about 700 microns, about 800 microns, about 900 microns, about 1000 microns, about 1100 microns, about 1200 microns, about 1300 microns, about 1400 microns, about 1500 microns, about 1600 microns, about 1700 microns, about 1800 microns, about 1900 microns, or about 2000 microns, or any range derived therefrom, such as spacing (in microns) of 100-2000, 200-1800, 400-1500, 800-1200, 100-500, 200-800, etc.

[0052]

[0077] In some embodiments, the areal density, also referred to as basis weight, of each of the layers (e.g., first layer, second layer, foam sheet, etc.) of the scaffold is independently about 60 g / m 2 , about 80g / m 2 , about 100g / m 2 , about 120g / m 2 , about 140g / m 2 , about 160g / m 2 , about 180g / m 2, about 200g / m 2 , about 220g / m 2 , about 240g / m 2 , about 260g / m 2 , about 280g / m 2 , or about 300 g / m 2 , or areal densities (g / m), such as 60-300, 80-280, 100-260, 120-240, 140-220, 160-200, 60-200, 60-140, 80-160, 100-260, and 200-300, that can be derived therefrom. 2 ), etc.

[0053]

[0078] In some embodiments, the scaffold has a strength of at least 50N, e.g., at least 60N, 70N, 80N, 90N, 100N, 110N, 120N, 130, 140N, 150N, 200N, 300N, 400N, 500N, 600N, 700N, 800N, 900N, 1000N, 1100N, 1200N, 1300N, 1400N, 1500N, 1600N, 1700N, 1800N, 1900N, or 2000N, or a strength derivable therein, e.g., 50-2000, 50-150, 60-140, 70-150, 80-150, 90-100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, or 2000N. The ball burst strength may be in any range, such as a ball burst strength (N) of 30, 80-120, 90-110, 50-100, 100-150, 50-80, 100-1900, 200-1800, 300-1700, 400-1600, 500-1500, 600-1400, 700-1300, 800-1200, 900-1100, 50-1500, 1000-2000, 50-300, 300-600, 600-900, 900-1200, 1200-1500, 1500-1800, or 1800-2000. Ball burst strength is measured by ASTM D3787 or ASTM D6797, which determines the force required to break or burst the fabric by forcing a steel ball through a mesh.

[0054]

[0079] In some embodiments, the mesh has any suitable mesh porosity in any range, such as a mesh porosity (%) of 0%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100%, or any range derivable therein, such as 0-100, 0-99, 5-95, 10-90, 15-85, 20-80, 25-75, 30-70, 35-65, 40-60, 45-55, 5-20, 20-40, 40-60, 60-80, 80-100, 80-99, 5-75, 10-60, 40-90, or 60-95.

[0055]

[0080] In some embodiments, the scaffold has a suture retention of at least 10N, e.g., at least 12N, 14N, 16N, 18N, 20N, 25N, 30N, 40N, 50N, 60N, 70N, 80N, 90N, 100N, 110N, 120N, 130N, 140N, 150N, 160N, 170N, 180N, 190N, or 200N, or any range derivable therein, such as 10-200, 10-30, 12-25, 14-20, 16-18, 10-20, 12-18, 18-30, 20-30, 25-30, etc. Suture retention is measured according to the method described in Deeken et al. (J. Mechanical Behavior Biomed. Mat., 74, 411-427 (2017)) and references cited therein, each of which is incorporated by reference in their entirety for all purposes. Briefly, a stainless steel wire is placed at a fixed distance from the edge of a mesh test specimen. The wire is then pulled at a constant rate in a constant rate of extension tensile tester, and suture retention is recorded as the maximum force sustained before mesh failure (i.e., when the stainless steel wire is pulled through the mesh by breaking the mesh).

[0056]

[0081] In some embodiments, the scaffold may be capable of similar elongation when pulled in all directions. In other embodiments, the scaffold may have a greater elongation in a first direction relative to the elongation in a second direction. In some embodiments, the scaffold may be capable of lateral rotation. In other embodiments, the scaffold may be capable of longitudinal rotation. In yet other embodiments, the scaffold may be capable of both lateral and longitudinal rotation. The scaffold specifications and construction result in a recoverable structure, allowing for compression and elongation of the scaffold without sustaining distortion.

[0057]

[0082] In some aspects, a scaffold can have any combination of features described herein, such as any combination of channel opening average diameter, channel average diameter, overall thickness, cross-layer stitch spacing, areal density, ball burst strength, suture retention, stretch directional properties, and rotational directional properties.

[0058]

[0083] In some embodiments, the scaffold is a surgical mesh for supporting soft tissue, the surgical mesh configured to be surgically implanted during one of breast reconstruction, breast augmentation, breast reduction, cosmetic breast surgery, tissue support and repair, tendon support and repair, and tissue engineering applications. In some embodiments, a method is disclosed for implanting the scaffold into a patient, optionally for at least one of breast reconstruction, breast augmentation, breast reduction, cosmetic breast surgery, tissue support and repair, tendon support and repair, and tissue engineering applications. In some embodiments, tissue is grown on the ex vivo scaffold. In some embodiments, this scaffold with ex vivo grown tissue is then implanted into a patient for any of the purposes described herein.

[0059]

[0084] In some embodiments, the scaffold can be manufactured in any suitable manner, including a method that includes knitting a first layer (e.g., a first knitted and / or woven layer) with a double needle warp knitter, knitting a second layer (e.g., a second knitted and / or woven layer) with a double needle warp knitter, and optionally attaching the first layer to the second layer by knitting at least one structure with the double needle warp knitter.

[0060]

[0085] In some embodiments, the first layer is a knitted layer, or both a knitted and woven layer. In some embodiments, the second layer is a knitted layer, or both a knitted and woven layer. In some embodiments, both the first layer and the second layer are knitted layers, or both a knitted and woven layer. When a layer is "both knitted and woven," it means that at least a portion of the layer is knitted and at least a portion of the layer is woven.

[0061]

[0086] In some embodiments, the scaffolds described herein can be manufactured in any suitable manner, including using a similar warp knitter, including a Russell double needle bar warp knitter, or a tricot single needle bar warp knitter. In some embodiments, similar or dissimilar knit structures can be formed on each of the needle bars using one guide bar, two guide bar, three guide bar, or additional guide bar stitch patterns to create similar or dissimilar layers, respectively, as previously described. For example, in some embodiments, the number of guide bars can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, or 32, or any range formed therefrom, such as 1-32, 2-30, 5-25, 10-15, 1-8, 1-10, 10-20, 20-32, 5-15, 15-25, or 25-32. In some embodiments, the density of the layers can be increased, for example, by using a basic tricot stitch pattern with fully threaded guide bars. Such layers are then connected by using an additional system of 1 guide bar, 2 guide bar, 3 guide bar, or additional guide bars to form at least one structure between the layers, such as a seam and / or a foam sheet. In some embodiments, at least one structure between layers, such as seams and / or foam sheets, can be threaded in a solid or skip configuration to increase or decrease the density of the resulting scaffold and / or optimize the macroporous structure of the scaffold through adjustment of the number of wales per inch, or number of stitches formed in the machine direction, and the number of courses per inch, or number of stitches formed in the cross machine direction. In some embodiments, any knitting and / or manufacturing step can employ a two-needle bar and up to 32 guide bars.In some embodiments, the step of knitting a first layer (e.g., a first knitted and / or woven layer) is performed using a first needle bar and up to 8 guide bars, the step of knitting a second layer (e.g., a second knitted and / or woven layer) is performed using a second needle bar and up to 8 guide bars, and an optional step of knitting at least one structure that oscillates from the first needle bar to the second needle bar is performed connecting the first and second layers using up to 8 guide bars.

[0062]

[0087] In some embodiments, for knitted layers or structures, the number of wales per inch of the layers and / or structures disposed therebetween (e.g., knits and / or foam sheets) is about 10 stitches per inch, about 15 stitches per inch, about 20 stitches per inch, about 25 stitches per inch, about 30 stitches per inch, about 35 stitches per inch, about 40 stitches per inch, about 45 stitches per inch, or a structure formed therefrom. The number of wales per inch (stitches per inch) may be any range, such as 10-15, 10-20, 10-25, 10-30, 10-35, 10-45, 15-20, 15-25, 15-30, 15-35, 15-40, 15-45, 20-25, 20-30, 20-35, 20-40, 20-45, 25-30, 25-35, 25-40, 25-45, 30-35, 30-40, 30-45, 35-40, 35-45, or 40-45. Each of the wales per inch or ranges described herein is independently applicable to any knitting and / or manufacturing step. The number of wales per inch is set by the number of needles per inch, typically counted per layer.

[0063]

[0088] In some embodiments, for woven layers or structures, the number of ends per inch of the layers and / or the structures disclosed therebetween (e.g., weave and / or foam sheets) is about 25, about 30, about 45, about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140, about 150, about 160, about 170, about 180, about 190, about 200, or about 250, or about 300, or about 450, or about 500, or about 600, or about 700, or about 800, or about 900, or about 1000, or about 1100, or about 1200, or about 1300, or about 1400, or about 1500, or about 1600, or about 1700, or about 1800, or about 1900, or about 2000, or about 3000, or about 4000, or about 5000, or about 6000, or about 7000, or about 8000, or about 9000, or about 10 ...0 may be any range, such as ends per inch of 25-200, 30-190, 35-180, 40-170, 45-160, 50-150, 60-140, 70-130, 80-120, 90-110, 25-100, 100-200, 25-50, 50-80, 80-110, 110-140, 140-170, or 170-200, formed therefrom. Each of the ends per inch or ranges described herein is independently applicable to any weaving and / or manufacturing step. The ends per inch is set by the number of needles per inch, typically counted per layer.

[0064]

[0089] In some embodiments, for knitted layers or structures, the number of courses per inch of the layers and / or structures disposed therebetween (e.g., knits and / or foam sheets) is about 3 stitches per inch, about 5 stitches per inch, about 10 stitches per inch, about 15 stitches per inch, about 20 stitches per inch, about 25 stitches per inch, about 30 stitches per inch, about 35 stitches per inch, about 40 stitches per inch, about 45 stitches per inch, about 50 stitches per inch. , about 55 stitches per inch, about 60 stitches per inch, about 65 stitches per inch, about 70 stitches per inch, about 75 stitches per inch, about 80 stitches per inch, about 85 stitches per inch, or any range formed therefrom, such as 3-85, 5-85, 10-80, 15-75, 20-70, 25-65, 30-60, 35-55, 40-50, 5-40, 10-30, 40-85, or 50-70 courses per inch (stitches per inch). Each of the courses per inch or ranges described herein is independently applicable to any knitting and / or manufacturing step. The courses per inch are set by the number of needles per inch, typically counted per layer.

[0065]

[0090] In some embodiments, for woven layers or structures, the number of picks per inch of the layers and / or structures disclosed therebetween (e.g., weave and / or foam sheets) can be about 25, about 30, about 45, about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140, about 150, or any range formed therefrom, such as 25-150, 30-140, 35-130, 40-130, 45-120, 50-110, 60-100, 70-90, 25-100, 80-150, 25-50, 50-80, 80-110, or 110-150 picks per inch. Each of the picks per inch or ranges described herein is independently applicable to any weaving and / or manufacturing step. The number of picks per inch is set by the number of needles per inch, typically counted per layer.

[0066]

[0091] In some embodiments, the scaffold may be manufactured via crochet using a single needle bar and guide bar with weft insertion technique to add additional systems of yarns that increase elasticity to facilitate attachment of fluids, bioactive fluids, cells, or other components, as discussed elsewhere herein. In some embodiments, the scaffold may be manufactured as a woven structure using a dobby loom with 8-32 harnesses, or on a jacquard loom with individual control of each end to create at least two layers, as described elsewhere herein. At least one structure, such as a foam sheet or stitch structure, is then formed to connect the layers using additional sets of yarns moving in either the warp or weft direction. In some embodiments, a leopard weave structure may be used to lock the yarns together to prevent movement of the yarns to ensure retention of the desired porosity. Various structures that perform the capabilities and functions of the scaffold may be created using a plain weave, a satin weave, or a twill weave.

[0067]

[0092] In some embodiments, the scaffold is positioned on a pin frame, tenter, or other heat treatment device after fabrication to relieve any stress present in the materials that make up the scaffold, such as the polymer fibers. In some embodiments, such a relaxation process allows for optimization and validation of stretch in the machine, cross-machine, and bias directions to ensure desired characteristics that lend themselves to in situ usability and patient comfort. In some embodiments, such validation processes may occur under ambient or inert conditions according to the required degradation profile, as discussed elsewhere herein. In some embodiments, the scaffold is then cleaned using an aqueous or solvent solution to remove spin finish, bioburden, endotoxins, and other processing aids that may be added during processing to facilitate manufacturability of the scaffold.

[0068]

[0093] In some embodiments, the scaffold undergoes the following process to maintain a desired degradation profile while achieving sterilization parameters under ISO 11135:2014 Sterilization of health care products-Ethylene oxide-Requirements for development, validation and routine control of a Sterilization process for medical devices (hereby incorporated by reference in its entirety for all purposes): The scaffold is exposed to ethylene oxide (EtO) gas for about 5 hours but not more than 5 hours and 5 minutes. The temperature range during exposure is closely monitored to ensure that the temperature does not drop below 115°F or exceed 125°F. Outgassing of EtO gas occurs via a controlled degassing process with temperatures of about 80°F to 130°F and a routinely maintained temperature of 110°F. The outgassing process continues for a period of time not exceeding 12 hours. Multiple temperature and / or humidity sensors are used throughout the sterilization process to closely monitor the temperature and humidity levels reached throughout the process to ensure adherence to the aforementioned parameters.

[0069]

[0094] Various aspects are contemplated herein, some of which are set forth in the following paragraphs. It is expressly contemplated that any aspect, or portions thereof, may be combined to form an aspect.

[0070]

[0095] Aspect 1: a first layer having a first plurality of channel openings; a second layer having a second plurality of channel openings; at least one structure disposed between the first layer and the second layer to form a volume therebetween, the volume comprising a channel and an internal passage; A mesh.

[0071]

[0096] Aspect 2: Mesh is a surgical mesh for soft tissue support, The mesh of aspect 1, wherein the surgical mesh is configured to be surgically implanted during at least one of breast reconstruction, breast augmentation surgery, breast reduction, cosmetic breast surgery, tissue support and repair, tendon support and repair, and tissue engineering applications.

[0072]

[0097] Aspect 3: the first layer has a first density, a first stitch pattern, or both; the second layer has a second density, a second stitch pattern, or both; (a) the first density and the second density are substantially the same; and / or (b) The mesh of any one of the preceding claims, wherein the first stitch pattern and the second stitch pattern are substantially the same.

[0073]

[0098] Aspect 4: the first layer has a first density, a first stitch pattern, or both; the second layer has a second density, a second stitch pattern, or both; (a) the first density and the second density are different; and / or (b) The mesh of any of the preceding aspects, wherein the first stitch pattern and the second stitch pattern are different.

[0074]

[0099] Aspect 5: (a) the first layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer; (b) the second layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer; or (c) The mesh of any of the preceding aspects, wherein both the first layer and the second layer are knitted layers, woven layers, or both knitted and woven layers.

[0075]

[0100] Aspect 6: 6. The mesh of any of the preceding embodiments, wherein the at least one structure comprises a foam sheet having corrugations.

[0076]

[0101] Aspect 7: 7. The mesh of any one of the preceding aspects, wherein at least one structure comprises a seam.

[0077]

[0102] Aspect 8: A mesh according to any of the preceding aspects, wherein the at least one structure is attached to at least one of the first layer and the second layer by knitting, weaving, sewing, melting, adhesive, or any combination thereof.

[0078]

[0103] Aspect 9: 9. The mesh of any of the preceding aspects, wherein the mesh is completely absorbed by the patient's body within 18 months.

[0079]

[0104] Aspect 10: 10. The mesh of any of the preceding aspects, wherein at least one of the first layer, the second layer, and the at least one structure comprises polydioxanone, poly-4-hydroxybutanoic acid, polylactic acid, polyglycolic acid, polycaprolactone, trimethylene carbonate, any copolymer thereof, or any combination thereof.

[0080]

[0105] Aspect 11: 11. The mesh of any of the preceding aspects, wherein at least one structure, when viewed as a cross-section of the mesh, forms a "V" shape, an "X" shape, a "W" shape, an "I" shape, a "U" shape, an "H" shape, an "N" shape, an "M" shape, an "A" shape, an "O" shape, a ladder shape, or any combination thereof.

[0081]

[0106] Aspect 12: 12. The mesh of any of the preceding aspects, wherein at least one of the first plurality of channel openings and the second plurality of channel openings defines a honeycomb shaped structure, a diamond shaped structure, a triangular shaped structure, a square shaped structure, a pentagonal shaped structure, a heptagonal shaped structure, an octagonal shaped structure, a circular shaped structure, an elliptical shaped structure, a star shaped structure, or any combination thereof.

[0082]

[0107] Aspect 13: 13. The mesh of any of the preceding aspects, wherein the first plurality of channel openings, the second plurality of channel openings, the channels, and the internal passages form a macroporous structure when implanted into a patient that permits infiltration of fluids and / or cells.

[0083]

[0108] Aspect 14: 14. The mesh of any of the preceding aspects, comprising at least one of a bioactive fluid, a regenerative agent, and a therapeutic agent.

[0084]

[0109] Aspect 15: 15. The mesh of any of the preceding embodiments, having a ball burst strength of at least 50 N.

[0085]

[0110] Aspect 16: 16. The mesh of any of the preceding aspects, wherein at least one of the first plurality of channel openings, the second plurality of channel openings, and the channels has an average diameter of at least 800 microns.

[0086]

[0111] Aspect 17: 17. A method of producing a mesh according to any of the preceding aspects, comprising the steps of: knitting the first layer using a double needle warp knitter; knitting a second layer using a double needle warp knitter; and Optionally, attaching the first layer to the second layer by knitting at least one structure with a double needle warp knitter; A method comprising:

[0087]

[0112] Aspect 18: (a) the first layer is a knitted layer or both a knitted layer and a woven layer; (b) the second layer is a knitted layer or both a knitted layer and a woven layer; (c) both the first layer and the second layer are knitted layers or both knitted and woven layers; The method according to embodiment 17, or any one of embodiments 1 to 16.

[0088]

[0113] Aspect 19: 19. The method of claim 17 or 18, or any of claims 1 to 16, wherein a wale measurement used during any one of the knitting steps is about 10 to 45 stitches per inch.

[0089]

[0114] Aspect 20: 19. The method of any one of embodiments 1 to 16, wherein the course measurement used during any one of the knitting steps is about 3 to 85 stitches per inch.

[0090]

[0115] Aspect 21: The method of any of aspects 17 to 20 or aspects 1 to 16, wherein any one of the knitting steps is performed using a two needle bar and up to 32 guide bars.

[0091]

[0116] Aspect 22: The step of knitting the first layer is: A method as described in aspect 21 or any of aspects 1 to 20, wherein the step of knitting the second layer is performed using a first needle bar and up to 8 guide bars, and the step of knitting the second layer is performed using a second needle bar and up to 8 guide bars, and an optional step of knitting at least one structure oscillating from the first needle bar to the second needle bar is performed, connecting the first layer and the second layer using up to 8 guide bars.

[0092]

[0117] Aspect 23: A method comprising implanting a mesh according to any one of aspects 1 to 16 or any one of aspects 17 to 22 into a patient.

[0093]

[0118] Aspect 24: a foam sheet having corrugations, the foam sheet extending along a plane; at least one of a thread or threads, an adhesive, a molten polymer, and a first layer attached to the crests of the corrugations of the foam sheet, the thread or threads being integral with the foam sheet to maintain the corrugations; A mesh comprising: The corrugations of the foam sheet define a volume extending along a plane; The volume includes a channel and an internal passageway, and If present, the first layer is a mesh having a first plurality of channel openings.

[0094]

[0119] Aspect 25: 25. The mesh of embodiment 24 or any of the preceding embodiments, wherein the first layer is present.

[0095]

[0120] Aspect 26:

[0036] A mesh according to embodiment 24 or 25 or any of embodiments 1-24, wherein the first layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer.

[0096]

[0121] Aspect 27: The mesh of any one of embodiments 24-26 or any one of embodiments 1-23, further comprising a second layer having a second plurality of channel openings.

[0097]

[0122] Aspect 28:

[0041] Embodiment 27. The mesh of any of embodiments 1-26, wherein the second layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer.

[0098]

[0123] Aspect 29: There is a first layer, (a) the first layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer; (b) the second layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer; or (c) The mesh of embodiment 27 or 28, or any of embodiments 1-26, wherein both the first layer and the second layer are knitted layers, woven layers, or both knitted and woven layers.

[0099]

[0124] Aspect 30: 30. The mesh of any one of embodiments 24 to 29 or any one of embodiments 1 to 23, wherein threads are present.

[0100]

[0125] Aspect 31: A method comprising implanting the mesh of any one of aspects 24-30, or any one of aspects 1-23, into a patient. EXAMPLES

[0101]

[0126] The descriptions and figures discussed herein provide parameters for the manufacture of such scaffolds and the resulting patterns using the parameters. The parameters and resulting patterns described herein are intended to be inclusive and other patterns and parameters may be used to achieve the capabilities and functions of the scaffolds described above. Example 1

[0102]

[0127] To create a single layer of the scaffold, a pattern simulation was created using a single needle bar knitting apparatus, for which parameters included a two guide bar macroporous structure (e.g., pattern) using 140 micron twist yarns. Pore size was measured in the "x" direction, which indicates the cross machine direction, and the "y" direction, which indicates the machine direction.

[0103]

[0128] FIG. 3A shows a scaffold stitch pattern with hexagonal channel openings and channels, as seen in the enlarged view of FIG. 3B. The estimated average diameter of the channel openings and channels in this scaffold stitch pattern was about 2.1 mm. Additionally, the channel opening size may also be expressed as 2.1 mm in the "x" direction and 2.3 mm in the "y" direction. FIG. 4A shows a scaffold with an atlas stitch pattern with a 6 stitches per inch course pattern including a plurality of hexagonal channel openings 400 and channels 402 and small pores 404, as seen in the enlarged view of FIG. 4B. The estimated average pore diameter of the channel openings and channels was about 1.8 mm. The channel opening size may also be expressed as about 1.8 mm in the "x" direction and 1.8 mm in the "y" direction. The estimated average diameter of the small pores was about 0.5 mm. The small pore size may also be expressed as about 0.5 mm in the "x" direction and 1.2 mm in the "y" direction.

[0104]

[0129] FIG. 5A shows a scaffold stitch pattern having an atlas stitch pattern with an 8 stitches per inch course pattern including multiple octagonal shaped channel openings 500 and channels 502 with small pores 504, as seen in the enlarged view of FIG. 5B. The estimated average diameter of the channel openings and channels is about 1.6 mm, and the size can also be expressed as 1.6 mm in the "x" direction and 1.8 mm in the "y" direction. The estimated average diameter of the small pores is about 0.8 mm, and the size can also be expressed as 0.8 mm in the "x" direction and 1.1 mm in the "y" direction. FIG. 6A shows a scaffold stitch pattern with oval shaped channel openings and channels, as seen in the enlarged view of FIG. 6B. The estimated average diameter of the channel openings and channels is about 0.8, and the size can also be expressed as 1.3 mm in the "x" direction and 0.8 mm in the "y" direction.

[0105] Example 2

[0130] A pattern simulation was created using a two-needle bar knitting apparatus to create a two-layer scaffold, for which parameters included a macroporous atlas structure stitch pattern on each layer with approximately 40 stitches per inch or courses per inch measurements at a gauge or wales per inch of 16 with one or two guide bars to stitch the foam pattern. Channel openings and channels were measured in areas with and without pile yarns. Channel openings and channels were measured in the "x" direction, which indicates the cross-machine direction, and the "y" direction, which indicates the machine direction. The target thickness of the scaffold was 1-1.5 mm. Specifically, the pattern simulation included various connection points for the interlayer foam sheets.

[0106]

[0131] FIG. 7A illustrates a scaffold stitch pattern with a single pile V-shaped weave cross-section as shown in FIG. 7B. In particular, FIGS. 7A and 7B illustrate a scaffold 700 comprising a first layer 702 (e.g., a first knitted and / or woven layer) having a first density, a first stitch pattern, and / or a first plurality of channel openings 710, a second layer 704 (e.g., a second knitted and / or woven layer) having a second density, a second stitch pattern, and / or a second plurality of channel openings (not shown), and at least one structure 706 disposed between the first layer 702 and the second layer 704 to form a volume 714 therebetween, the volume comprising channels 712 and internal passages 708. In this case, the at least one structure 706 includes several structures 706 that are "V" shaped seams having vertices 709.

[0107]

[0132] FIG. 7C shows a scaffold stitch pattern with a double pile V-shaped weave cross section resulting in a parallel "X" cross section formation shown in FIG. 7D. The estimated size of the pile-free channel openings and channels was 1.6 mm in the "x" direction and 1.8 mm in the "y" direction. The estimated size of the pile channel openings and channels was 1.4 mm in the "x" direction and 1.7 mm in the "y" direction. FIG. 7C and FIG. 7D can also be described similarly to FIG. 7A and FIG. 7B.

[0108]

[0133] FIG. 8A shows a scaffold stitch pattern with a single pile bracket-type parallel "X" cross-section shown in FIG. 8B. FIG. 8C shows a scaffold stitch pattern with a double pile bracket-type parallel "X" cross-section resulting in a bracket-type triple parallel "X" cross-section shown in FIG. 8D. The estimated size of the pile-free channel opening and channels was 1.6 mm in the "x" direction and 1.8 mm in the "y" direction. The estimated size of the pile channel opening and channels was 1.5 mm in the "x" direction and 1.7 mm in the "y" direction. FIGS. 8A-8D have similar features as FIGS. 7A-7B and therefore can be described similarly to FIGS. 7A-7B.

[0109]

[0134] FIG. 9A shows a scaffold stitch pattern with a single pile bracketed elongated "X" cross section shown in FIG. 9B. FIG. 9C shows a scaffold stitch pattern with a double pile bracketed elongated "X" cross section resulting in a ladder-type arrangement bracketed by triangles in the cross section shown in FIG. 9D. The estimated size of the pile-free channel opening and channels was 1.6 mm in the "x" direction and 1.8 mm in the "y" direction. The estimated size of the pile channel opening and channels was 1.5 mm in the "x" direction and 1.8 mm in the "y" direction. FIGs. 9A-9D have similar features as FIGs. 7A-7B and therefore can be described similarly to FIGs. 7A-7B.

[0110]

[0135] While this invention has been described as having an exemplary design, it is capable of further modification within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

Claims

1. A mesh comprising: a first layer having a first plurality of channel openings; a second layer having a second plurality of channel openings; at least one structure disposed between the first layer and the second layer to form a volume between the first layer and the second layer, the volume comprising a channel and an internal passage; Equipped with the at least one structure is attached to at least one of the first layer and the second layer by knitting, weaving, sewing, melting, adhesive, or any combination thereof; the first layer having a first density, a first stitch pattern, or both, and the second layer having a second density, a second stitch pattern, or both; (i) (a) the first density and the second density are substantially the same, and / or (b) the first stitch pattern and the second stitch pattern are substantially the same, or (ii) (a) the first density and the second density are different, and (b) the first stitch pattern and the second stitch pattern are different.

2. 10. The mesh of claim 1, wherein the mesh is a surgical mesh for soft tissue support, the surgical mesh being configured to be surgically implanted during at least one of breast reconstruction, breast augmentation surgery, breast reduction, cosmetic breast surgery, tissue support and repair, tendon support and repair, and tissue engineering applications.

3. (a) the first density and the second density are different; and 2. The mesh of claim 1, wherein (b) the first stitch pattern and the second stitch pattern are different.

4. (a) the first layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer; (b) the second layer is a knitted layer, a woven layer, or both a knitted layer and a woven layer; or 10. The mesh of claim 1, wherein (c) both the first layer and the second layer are knitted layers, woven layers, or both knitted and woven layers.

5. The mesh of claim 1 , wherein the at least one structure comprises a foam sheet having corrugations.

6. The mesh of claim 1, wherein the mesh is completely absorbed by the patient's body within 18 months.

7. 10. The mesh of claim 1, wherein at least one of the first layer, the second layer, and the at least one structure comprises polydioxanone, poly 4 hydroxybutanoic acid, polylactic acid, polyglycolic acid, polycaprolactone, trimethylene carbonate, any copolymer thereof, or any combination thereof.

8. 2. The mesh of claim 1, wherein the at least one structure forms a "V" shape, an "X" shape, a "W" shape, an "I" shape, a "U" shape, an "H" shape, an "N" shape, an "M" shape, an "A" shape, an "O" shape, a ladder shape, or any combination thereof, when viewed through a cross-section of the mesh.

9. 10. The mesh of claim 1, wherein at least one of the first plurality of channel openings and the second plurality of channel openings defines a honeycomb shaped structure, a diamond shaped structure, a triangular shaped structure, a square shaped structure, a pentagonal shaped structure, a heptagonal shaped structure, an octagonal shaped structure, a circular shaped structure, an elliptical shaped structure, a star shaped structure, or any combination thereof.

10. 10. The mesh of claim 1, wherein the first plurality of channel openings, the second plurality of channel openings, the channels, and the internal passages form a macroporous structure that permits infiltration of fluids and / or cells when implanted in a patient.

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