Implantable breast harness

Abstract

An implantable harness for supporting a breast shaping element on a target surface for a breast reconstruction or augmentation procedure includes a base section configured to conform to at least a portion of an anterior side of the breast shaping element and a plurality of fixation extensions configured for anchoring to the target surface to support the breast shaping element thereon. Each of the fixation extensions extend outward from a peripheral edge of the base section to a distal end. The base section and the plurality of fixation extensions are formed from a macroporous material comprising a plurality of pores. The plurality of fixation extensions project outward from the base section in at least two different directions.

Description

IMPLANTABLE BREAST HARNESSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of, and claims priority to, U.S. Provisional Application 63 / 558,721, filed February 28, 2024, which is hereby incorporated herein by reference in its entirety for all purposes.FIELD

[0002] The present disclosure relates to implantable mesh devices for breast augmentation and reconstruction procedures and methods of use.BACKGROUND

[0003] Breast augmentation, restorative, and reconstructive procedures utilizing breast shaping elements, whether implants or native tissue, to restructure a patient’s breast or breasts are increasing in popularity. When breast tissue is restored, it is often re-positioned in the chest wall to a more natural / youthful shape. When an implant is used, the implant is positioned within the chest which may be pre-pectoral, above the pectoral muscle, or submusclular (below the muscle). There are additional subtleties such as partially submuscular, partially under the pectoral muscle, or totally submuscular (completely behind the pectoral muscle and even serratus anterior). Over the past several years, surgeons have increasing been utilizing surgical mesh to support breast implants in augmentation, restoration, and reconstructive procedures. The surgical mesh provides support for the native breast tissue to maintain a more youthful shape when the tissue is repositioned and in the case of an implant, it is used to protect the skin from implant erosion, secure the implants place in the soft tissue envelope, and to promote capsule formation The mesh may also be used for breast reshaping or support in mastopexies or reductions, for example, inframammary fold reconstruction, capsulorrhaphy, or modulating shape and appearance of breasts reconstructed with native tissue.

[0004] Regardless of the location of the breast shaping element, an incision is made to access that location. Common locations for incisions include through existing scars or through fresh incisions created for mastectomies, mastopexies, or reductions, the inframammary fold, the areola, the umbilicus, and the axilla. An inframammary incision is made along the inframammaryfold; a periareolar incision runs along the border of the areola and skin; an umbilical incision is made in the belly button; and a transaxillary incision is made in the armpit / axilla. These incisions provide access to the breast for reconstruction, restoration, or augmentation.SUMMARY

[0005] This Summary is provided to introduce a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.

[0006] In one implementation, an implantable harness for supporting a breast shaping element on a target surface for a breast reconstruction or augmentation procedure includes a base section configured to conform to at least a portion of an anterior side of the breast shaping element and a plurality of fixation extensions configured for anchoring to the target surface to support the breast shaping element thereon. Each of the fixation extensions extend outward from a peripheral edge of the base section to a distal end. The base section and the plurality of fixation extensions are formed from a macroporous material comprising a plurality of pores. The plurality of fixation extensions project outward from the base section in at least two different directions.

[0007] In another implementation, a mesh is prepared into a harness to encapsulate or support a breast implant. The mesh may be precut (e.g., by laser, die, water-jet, scissors, etc.) or can be prepared in the surgical field by the surgeon using a template specifically engineered for a range of paticnt-spccific sizes. Several shapes or templates may be offered to accommodate varied patient diameters and projections (e.g. low, medium, high profiles). As a knit polymer implant, heat-seating may occur inline as a flat sheet to improve mechanical characteristics or post knitting over a domed shape to improve conformance to a breast shaping implant.

[0008] The mesh may be generally circular in shape, optionally with multiple tabs extending radially outward that are configured to conform to a breast shaping element when curled around the implant. The tabs may be shaped such that when wrapped around a breast shaping element their edges touch. For example the based section of the harness may be shaped with multiple petal-shaped tabs configured such that, when the petals are folded over the breast shaping element, the ends of the petals cover at least a portion, and in some embodiments substantially all, of a posterior side of the breast shaping element.

[0009] In another implementation, a method of implanting a harness and a breast shaping clement includes passing distal ends of fixation extensions through a target surface at initial bite locations. A body of the fixation extensions are pulled through the initial bites by the distal ends to pull the harness and the breast shaping element into position on the target. Once the harness and the breast shaping element are in the desired position on the target surface, the unattached fixation extensions are passed through the target surface at secondary bite locations around the perimeter of the harness and breast shaping element. The fixation extensions may be secured to the target surface at or near the respective bite location, optionally using a self- locking stich, to anchor the harness and the breast shaping element to the target surface. Optionally, the initial bite locations are located above the desired final position of the harness and breast shaping element.

[0010] Various other features, objects, and advantages of the invention will be made apparent from the following description taken together with the drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The present disclosure includes the following Figures.

[0012] FIG. 1 illustrates an embodiment of a porous implantable harness for supporting a breast shaping element.

[0013] FIG. 2 illustrates the implantable harness of FIG. 1 with a breast shaping element.

[0014] FIG. 3 illustrates a lateral edge of the implantable harness of FIG. 2 with porous fixation extensions.

[0015] FIG. 4 illustrates an embodiment of a porous fixation extension configured as a mesh fixation extension.

[0016] FIG. 5 illustrates another embodiment of a porous fixation extension including a straight fixation device.

[0017] FIGS. 6A-6C are schematic views of a porous material body for forming the implantable harness.

[0018] FIG. 7 is another view of the element formed of the porous material of FIG. 6A, which is for forming the implantable harness.

[0019] FIGS. 8-10 illustrate an exemplary implantable harness configuration and steps for anchoring the implantable harness and breast shaping element of FIG. 2 to a target surface.

[0020] FIGS. 11 A-l ID illustrate a method for anchoring a porous suture to a target surface with a porous fixation extension.

[0021] FIGS. 12A-12D illustrate another method for anchoring the implantable harness to a target surface with a porous fixation extension.

[0022] FIG. 13 is a detailed view of an exemplary implantable harness and breast shaping element and illustrating another method for anchoring the implantable harness to a target surface with a porous fixation extension.

[0023] FIG. 14A illustrates another embodiment of a porous implantable harness for supporting a breast shaping element.

[0024] FIG. 14B illustrates the porous implantable harness of FIG. 14A with a breast shaping element.

[0025] FIG. 15 illustrates another embodiment of a porous implantable harness with a breast shaping element with vertical support straps.

[0026] FIG. 16 illustrates the implantable harness and breast shaping element of FIG. 15 anchored to a target surface with vertical support straps.

[0027] FIG. 17 illustrates another embodiment of a porous implantable harness for supporting a breast shaping element.

[0028] FIG. 18 illustrates a porous material for forming the harness of FIG. 17.

[0029] FIG. 19 illustrates the harness of FIG. 17 with a breast shaping element.

[0030] FIGS. 20-22 illustrate steps for securing the harness of FIG. 19 to a breast shaping element.

[0031] FIGS. 23 and 24 illustrates steps for positioning and anchoring a porous implantable harness and a breast shaping element to a target surface.

[0032] FIGS. 25A-25D illustrate a method for anchoring a separable fixation extension to a perimeter edge of the base section of an implantable harness.

[0033] FIG. 26 illustrates another embodiment of a porous implantable harness with another a breast shaping element.DETAILED DESCRIPTION

[0034] In the present description, certain terms have been used for brevity, clarity and understanding. No unnecessary limitations are to be inferred therefrom beyond the requirement ofthe prior art because such terms are used for descriptive purposes only and are intended to be broadly construed.

[0035] As used herein, unless otherwise limited or defined, discussion of particular directions is provided by example only, with regard to particular embodiments or relevant illustrations. For example, discussion of “top,” “bottom,” “front,” “rear',” “left,” “right,” “horizontal,” “vertical,” and “longitudinal” features and / or relative motion, e.g., movement “up” and “down,” is generally intended as a description only of the orientation of such features relative to a reference frame of a particular example or illustration. Correspondingly, for example, a “top” feature may sometimes be disposed below a “bottom” feature (and so on), in some arrangements or embodiments. Additionally or alternatively, embodiments may be arranged in a different orientation such that “top” and “bottom” features are arranged horizontally relative to each other, for example in a “left-to-right” orientation.

[0036] The use herein of the terms “including,” “comprising,” or “having,” and variations thereof, is meant to encompass the elements listed thereafter and equivalents thereof, as well as additional elements. Embodiments recited as “including,” “comprising,” or “having” certain elements are also contemplated as “consisting essentially of’ and “consisting of’ those certain elements.

[0037] FIGS. 1-3 illustrate an embodiment of a porous implantable harness 50 configured for use in breast reconstruction and / or augmentation procedures, for example to support a breast shaping element 40 at a target location. In the illustrated embodiments, the harness 50 is configured to support a breast shaping element 40 configured as a synthetic, body safe breast implant 40. Embodiments of the porous implantable harness 50 may also be configured for use with other types of breast shaping elements. For example, the harness 50 may be used to support native tissue utilized as a breast shaping element. Additionally or alternatively, embodiments of a porous implantable harness 50 may be configured to support other types of implants, expanders, biological material, and / or other objects on a target surface.

[0038] Referring to FIGS. 1 and 2, the illustrated harness 50 includes a flexible, generally planar base section 51 formed from a macroporous material and a plurality of fixation extensions 100 extending outward from a peripheral edge of the base section 51. The macroporous material forming the illustrated base section 51 is a mesh material that has an openwork structure or pattern that defines a plurality of pores arranged throughout the base section 51 , as described in furtherdetail below. The base section 51 extends vertically from an upper edge 52 to a lower edge 54 to define a height dimension Hh of the harness 50 and laterally between a first lateral edge 56 and a second lateral edge 58 to define a width dimension Wh of the base section 51. The base section 51 has a generally semicircular shape with a generally straight upper edge 52 and symmetrical lateral edges 56, 58 that curve downward and laterally inward towards the lower edge 54. The outer edge of the base section 51, including the lateral edges 56, 58 lower edge of the base section may be shaped to approximate a curvature of a lower side of the breast shaping element, such as shown in FIGS. 1 and 2. In the illustrated embodiments, the base section 51 has a lower edge 54 that is generally straight. Some embodiments, however, may include lateral edges 56, 58 which curved towards a lower edge 54 at lateral midpoint of the base section 51 without a flat section (e.g., with a continuous curve along the lateral and lower edges 54, 56, 58 of the base section 51).

[0039] The width Wh and height H dimensions of the base section 51 may be selected based on the dimensions of the breast shaping element 40, for example to conform to at least a portion of an anterior side and / or posterior side of the breast shaping element 40. As illustrated in FIG. 2, for example, the base section 51 of the harness 50 is shaped and sized to conform to at least a lower portion of the anterior side of the breast shaping element 40 to securely support the breast shaping element 40 on a target surface. As also illustrated in FIG. 8-10 and 13 and discussed in further detail below, some embodiments of a harness 50 may have a base section that at least partially extends around a lower portion of the breast shaping element 40. The base section 51 is positioned over the anterior side 40a of the breast-shaping element 40. The base section 51 is configured to conform to the curved shape of the breast- shaping element, which here is shown as a silicon or saline implant.

[0040] The semicircular base section 51 approximates the circular shape of the breast shaping element and is dimensioned to cover at least a portion of the anterior side of the breast shaping element so as to retain it in place once implanted in the patient. For example, the base section 51 may be configured to cover at least a lower third of the anterior side of the breast shaping element. In other embodiments, the base section 51 may be configured to cover at least a lower half of the anterior side of the breast shaping element. Such an embodiment is illustrated in FIG. 2, where the height Hh of the base section is greater than half the diameter Di of the breast shaping element 40 such that the base section 51 covers at least the lower half of the breast shaping element 40. For example, the base section 51 may be configured such that the height Hh is at least 60% ofthe diameter Di of the breast shaping element 40. In another embodiment, the base section 51 may be configured such that the height Hh is at least 70% of the diameter Di of the breast shaping element 40. The width Wh (see FIG. 1) of the base section 51 is greater than the diameter Di of the breast shaping element 40 to enable the base section 51 to wrap around the widest section of the anterior side 40a with enough excess to reach around the sides of the breast shaping element 40.

[0041] As explained in more detail below, the base section 51 may be sized to wrap around the sides of the lower portion (such as at least the lower half, as shown) such that it can be affixed to the surrounding tissue. In some embodiments, the base section 51 may be sized and shaped to wrap around at least a portion of the posterior side of the breast shaping element as well such that the base section 51 encapsulates at least part of the breast shaping element-e.g., forming a cup around at least the lower portion of the breast shaping element. In some implementations, it may be desirable for the base section 5 Ito cover only the lower side of the implant, and thus may cover less than one third of the anterior and / or posterior side of the breast shaping element. The based section 51 may be configured as a sling that supports only the lower side of the breast shaping element preventing it from moving downward and thus causing the double-bubble effect, which is a breast deformity that occurs when a breast implant sits below the breast's natural fold. As is discussed in more detail below, the base section 51 may be convex, or arc-shaped to curve outward such that it conforms to the anterior surface 40a of the breast shaping element 40. For example, the base section 51 may be heat-set prior to implantation such that it takes on a curvature that matches that of the breast shaping element.

[0042] Referring to FIGS. 1 through 3, the illustrated implantable porous harness 50 includes porous fixation extensions 100 configured for anchoring the harness 50 to a target surface to support the breast shaping element 40 thereon. In FIG. 3, the fixation extensions 100 are shown in a stored configuration in a holding apparatus 38. The fixation extensions 100 extend laterally outward from the first and second lateral edges 56, 58 of the base section 51 and are formed from a macroporous material, which may be the same or different than the macroporous material of the base section 51. Each fixation extension 100 extends from an interior end 104, which is attached to a corresponding lateral edge 56, 58 of the base section 51, to a distal end 106 including a fixation device 114 for anchoring the harness 50 to a target surface.

[0043] Embodiments of an implantable porous harness 50 may be configured with a plurality of fixation extensions 100 that extend in multiple directions from the base section 51.This may be useful, for example, to securely anchor the harness 50 and the breast shaping element 40 in the desired position on the target surface. In the embodiments of FIGS. 1-3, the mesh harness 50 is generally symmetrical and includes five fixation extensions 100 extending outward from the first lateral edge 56 in a first lateral direction and five fixation extensions 100 extending outward from the second lateral edge 56 in a second lateral direction opposite the first lateral direction. The fixation extensions 100 are evenly spaced in the vertical direction along the lateral edges 56, 68. On each lateral side of the base section 51, an upper fixation extension 100 is generally aligned with the upper edge 52 of the base section 51 and a lower fixation extension 100 is generally aligned with the lower edge 54 of the base section 51. The even and symmetrical spacing of the fixation extensions 100 around the perimeter of the base section 51 may be useful, for example, so that the force imparted on the target surface by a harness 50 affixed to said target surface is evenly distributed. In one embodiment, the device may only need two opposing extensions along the outer perimeter, which may then be used to be passed through the mesh body to sew the perimeter of the implant to the target tissue. Further details regarding such an embodiment are disclosed herein, such as with respect to FIG. 13.

[0044] As will be discussed in further detail below, some embodiments of an implantable porous harness 50 for supporting a breast shaping element 40 may be configured with a different arrangement of fixation extensions 100 (see, e.g., FIGS. 14A-25). For example, a harness 50 may include a different number of fixation extensions 100, an uneven distribution of fixation extensions 100 along at least one lateral edge 56, 58 of the base section 51 , and / or one lateral edge 56, 58 may include a different number of fixation extensions 100 than the other one of the lateral edges 56, 58. Additionally or alternatively, a harness 50 may include at least one fixation extension 100 that extends from the base section in a third direction that is different than the first and second lateral directions. Some embodiments of an implantable porous harness 50 may be configured with at least one fixation extension 100 that extends in a vertical direction from the upper edge 52 and / or the lower edge 54 of the base section 51. For example, an embodiment of a harness 50 may be configured with at least one fixation extension 100 that extends vertically from the upper edge 52 of the base section 51 so that said extensions support the harness 50 and the breast shaping element 40 from a location on the target surface 90 that is above the desired position of the breast shaping element 40 on the target surface (see, e.g., FIGS. 15 and 16).

[0045] Referring to FIG. 3 and to FIG. 4, which illustrates a partial view of a porous fixation extension 100 formed from a mesh material, as well as FIGS. 5 and 6 A, the illustrated fixation extension 100 has a flexible, generally planar body 102 that extends longitudinally from a interior end 104 to an opposite distal end 106 to define a length dimension Leof the fixation extension 100 and laterally between opposing first and second lateral sides 108, 110 to define a width dimension Weof the fixation extension 100. In some embodiments, the porous fixation extension may have more than one distal end 106, such as a fixation extension that splits into multiple lengths of porous fixation extension at some point along its length Leand thus provides one side with multiple ends.

[0046] The body 102 of the fixation extension 100 is generally flat, such as having a substantially larger width Wethan thickness Te(and wherein the length Leis substantially larger than the width We). The width Weis substantially wider than that of a suture thread, such as a standard suture thread having a typical width in the range of 0.01 to 0.7 mm, which provides the adhesion and tension-bearing benefits described herein. For example, the width Wemay be at least 2mm, and for many applications may be greater than 5mm. Exemplary lengths Lc, widths Wc, and thicknesses, and desirable proportions for such dimensions, are described below. The generally Hat body 102 may be formed of a single-ply material or fabric. Alternatively, it may be formed of a multi-ply fabric where the pores 120, 122 provide a passage or path through all of the plies, or layers. As described in more detail below, the material of the 102 may be configured to maintain its width Wewhen under lengthwise tension, or at least a substantial portion the original width Wethat it has when not under tension. This enables the porous fixation extension 100, once implanted, to distribute the load across a wider area of tissue compared to prior art fixation devices, and also enables tissue ingrowth and adhesion to provide superior performance for high-tension applications (such as breast tissue repairs).

[0047] With continued reference to FIGS. 3 and 4, the body 102 of the fixation extension 100 is formed from a macroporous mesh material. The body 102 of the mesh porous fixation extension 100 may be an arrangement of biocompatible textile strands 130 that are knitted, woven, sewn, braided, and / or otherwise linked to form a continuous, flexible material. The mesh material forms a pattern of pores 120, 122 (FIG. 4) across the width Weand length Leof the porous fixation extension 100, which may comprise one or several pores 120, 122 across the width and several pores along the length Le. The pores 120, 122 may be distributed in a consistent pattern across thelength Leand / or width We, or they may be concentrated in certain areas along the length Leor width We.

[0048] The textile strands 130 of the extension body 102 may collectively form an openwork structure or pattern that defines a plurality of pores 120, 122 arranged along the length Leof the body 102 between the interior and distal ends 104, 106, and across the width Weof the body 102 between the first and second lateral sides 108, 110. For example, the mesh fixation extension 100 includes a plurality of central pores 120 arranged along the lateral midpoint of the body 102 between the interior and distal ends 104, 106, and a plurality of lateral pores 122 offset laterally relative to the central pores 120 towards the first or second lateral sides 108, 110. The pores 120, 122 are configured to allow the fixation extension 100 to be passed through itself when anchoring the fixation extension 100 to a target surface. Furthermore, the plurality of pores 120, 122 give the fixation extension body 102 a lattice structure that may be useful, for example, to encourage tissue in-growth. As the tissue proximate an implanted porous fixation extension 100 heals, scar tissue or other tissue types may form, grow, or otherwise extend into at least some of the pores 120, 122. Engagement between the ingrown tissue and the pores 120, 122 inhibits movement of the fixation extension 100, thereby reducing movement of the fixation extension 100 relative to the target surface once anchored thereto.

[0049] In the illustrated embodiments, the macroporous mesh fixation extensions 100 are formed from the same mesh material which forms the macroporous base section 51. That is, the illustrated fixation extensions 100 are extensions of the macroporous material which forms the base section 51 , and the base section 51 therefore has the same pattern of pores that is present on the fixation extensions 100. Each of the textile strands 130 that form the extension body 102 and the base section 51 may be, for example, monofilaments, braided filaments, a combination of monofilament and braided filaments, and / or another thread, filament or strand-like construction. The textile strands 130 may be formed from filaments comprising one or more of biocompatible metals of a permanent (e.g., stainless steel, titanium, etc.) or degradable nature (e.g., magnesium alloy, etc.); a biocompatible synthetic polymer of a permanent (e.g., polypropylene, polyester, etc.) or degradable nature (e.g., polylactic acid, polypropylene fumarate, polylactic-co-glycolic acid, etc.); and / or a collagen-based material e.g., allograft, xenograft, etc.). In some embodiments the mesh fixation extension body 102 and / or the base section 51 comprises a synthetic mesh, which is a mesh made from biocompatible and synthetic materials, such as polypropylene, polyethyleneterephthalate polyester, expanded polytetrafluroethylene (ePTFE), polyglactin, polyglycolic acid, trimcthylcnc carbonate (TMC), caprolactone, polydioxanonc (PDO), poly-4-hydroxybutyratc (P4HB), and / or polyglycolide, polyactide. In some embodiments, the body 102 of the fixation extensions 100 comprises a biological sheet or mesh, which is a sheet or mesh made from biocompatible and biological materials, such as human dermis, porcine dermis, porcine intestine, bovine dermis, and / or bovine pericardium. Additionally or alternatively, the extension body 102 and / or the base section 51 may be comprised of a combination of synthetic and biologic materials and / or a combination of degradable and non-degradable materials.

[0050] In knitted, woven, and / or braided fixation extensions, the textile strands 130 may be organized to optimize the biomechanical properties, such as tensile strength, as well as for porosity, morphology, and geometry as they relate to tensile strength and bioincorporation, which also influences tensile strength and frictional resistance. Various knitting techniques known in the art may be used to create the mesh fixation extension body 102 of the fixation extension 100 and / or of the base section 51. These include, but are not limited to, warp knitting, weft knitting, Crochet knitting, and Rachel knitting. Additionally or alternatively, various weaving techniques known in the art may be used to create the mesh fixation extension body 102 of the fixation extension 100 and / or of the base section 1. These include, but are not limited to, hexagonal open stitching (e.g., PARIETINE® mesh), interlocking fiber junctions (e.g., PROLENE® mesh, SURGIPRO Pro® mesh), diamond shape open stitching (e.g., ULTRAPRO® mesh), 2-dimensional weaves, and 3- dimensional weaves.

[0051] While the fixation extensions 100 illustrated in FIGS. 1-4 are configured as mesh fixation extensions, some embodiments may be differently configured. For example, referring to FIG. 5, an embodiment of a porous fixation extension 200 and / or of the base section may be formed from a generally planar' material with a plurality of pores formed therethrough. Similarly to the fixation extension of FIG. 4, the body 202 of the fixation extension 200 of FIG. 5 extends longitudinally from a first end 204 to a second end 206 and laterally between opposing first and second lateral sides 208, 210. The porous fixation extension 200 includes a plurality of pores 212 formed along the length Leof the body 202 between the first end 204 and the second end 206 thereof. As with the pores 120, 122 of FIG. 4, each of the pores 212 is configured to allow the porous fixation extension 200 to be passed through its body 202 via said pore 212 during attachment of the porous fixation extension 200 to a target surface.

[0052] The body 202 of the fixation extension 200 is constructed from any biocompatible material and may be configured to be permanent, removed, or degradable. For example, the porous fixation extension 200 may include one or more materials or filaments that may comprise a biocompatible metal of a permanent nature (e.g., stainless steel, titanium, etc.) or a degradable nature (e.g. , magnesium alloy, etc.); a biocompatible synthetic polymer of a permanent nature (e.g. , polypropylene, polyester, etc.) or a degradable nature (e.g., polylactic acid, polypropylene fumarate, polylactic-co-glycolic acid, etc.); and / or a collagen-based material (e.g., allograft, xenograft, etc.). For example, the body 202 of the porous fixation extension 200 may be formed of multiple filaments or textile strands, which may include a mix of any of the above-listed materials, and may be a knitted, woven, sewn, spun, and / or braided fabric body 202. Alternatively or additionally, the porous fixation extension may be formed by cutting (e.g. laser, die, etc.), printing (e.g., FDM, SLA. DLP, SLM, etc.)

[0053] While the illustrated embodiments of the fixation extensions 100, 200 are generally flat in thickness, in other embodiments the fixation extension body 102, 202 may have a more substantial depth. While the porous fixation extensions 100, 200 of FIGS. 4 and 5 are depicted as having generally planar bodies 102, 202 formed with a single layer, some embodiments may have multi-layer and / or a larger depth cross-section, such as a round, square, or triangular cross-section, to provide just a few examples. In such larger-depth embodiments, the fixation extension body 102, 202 may have a solid or hollow cross-section. Optionally, such a larger depth fixation extension may be configured such that it substantially flattens in thickness upon implantation, yet substantially maintains its width We.

[0054] As previously mentioned, the porous fixation extensions 100 of the harness 50 include fixation devices 114 at their distal ends 106. The fixation devices 114 may be any element or series of elements that enable fixation of the porous fixation extension 100 to the target surface. Exemplary fixation devices 114 include, but are not limited to, surgical needles or other rigid or semi-rigid bodies formed at one or both ends of the fixation extension, staples, tacks, screws, laser- assisted tissue welding, fibrin sealant, glue, salute “Q” ring, Mitek anchors, and / or other fixation devices. Each fixation device 114 may be permanently, degradably, or removably attached to a location of the fixation extension. Where the fixation device 114 is configured for passing the fixation extension through the tissue, such as the needles 114 shown in FIGS. 3 and 5, it may be permanently or removably attached to the distal end 106 of the porous fixation extension 100.Alternatively or additionally, the fixation device 114 may be permanently, degradably, or removably attached to another portion of the extension body 102. Moreover, the fixation device 114 may be an element that is permanently or transiently implanted in the patient, or that is removed from the porous fixation extension 100 once it is implanted in a patient.

[0055] The fixation devices 114 shown in FIGS. 4 and 5 are surgical needles configured to assist in affixing the porous fixation extension 100, 200 into the target surface — z.e., to allow the user to pass the porous fixation extension 100, 200 through the target surface and / or to pass the fixation extension through itself or to otherwise form a stitch to secure it to the tissue, as described in more detail below. In particular, the porous fixation extension 100 of FIG. 3 includes a fixation device 114 configured as a curved needle and the fixation extension 200 of FIG. 5 includes a fixation device 114 configured as a straight needle. In other embodiments, the needle may be an “s” shape or other multi-directional shape configured to forge a predefined path through tissue. The needles 114 may be formed of metal or of any rigid material suitable for penetrating tissue. Alternatively, the fixation device may be a flexible shaft containing the end of the porous fixation extension.

[0056] The material(s) selected for use in the base section 51 and / or the mesh extensions 100 of a harness 50 may be selected based on one or more desired parameters or characteristics of the porous base section 51 and / or the porous fixation extension 100. For example, at least one material that forms the harness 50 may be selected based on a desired modulus of elasticity and / or flexural rigidity so said the porous fixation extension 100 is flexible enough that it may be passed back and forth through target surfaces (e.g., tissue) and through its own body 102 via the pores 120, 122. Additionally or alternatively, embodiments of the porous fixation extensions 100 may be configured with a length dimension Le, a width dimension We, and / or a thickness dimension Teselected based on one or more desired parameter(s) of the porous fixation extension 100. For example, at least one of the length Le, width We, and thickness Teof the porous fixation extension 100 may be dimensioned based on the desired flexural rigidity of the porous fixation extension 100. In an exemplary embodiment, a porous fixation extension 100 may be configured to have a flexural rigidity that is less than or equal to 0.001Pa*mA4. Some embodiments, however, may be configured to have a flexural rigidity that is greater than 0.001Pa*mA4.

[0057] In the illustrated embodiments, the porous fixation extensions 100 have a length Lewhich permits multiple anchor points within the target surface upon implantation. An anchor pointis a position where a fixation extension 100 passes through some portion of the target surface to provide a force against migration or dehiscence. For example, as discussed in more detail below, each fixation extension 100 may be passed through the target surface multiple times, such as by weaving or sewing the porous fixation extension 100 into the tissue with at least one fixation device 114. Thereby, the porous fixation extension 100 may be configured such that it can withstand substantial forces, including for example, tensile stress, without failure.

[0058] In an exemplary embodiment, the length Leof a fixation extension 100 may be between 80mm and 1000mm long. Some embodiments, however, may have a length Lethat is shorter than 80mm or longer than 1000mm. For example, the length Leof a fixation extension 100 may be 30mm, 40mm, 50mm, 60mm, 70mm, 1100mm, 1200mm, 1300mm, 1400mm, 1500mm, or any other length Lesuitable for the intended use of said fixation extension 100, including lengths Lewhich are longer or shorter than the enumerated lengths Le, and lengths Lethat are between any of the enumerated lengths Le.

[0059] In some embodiments, the body 102 of the porous fixation extension 100 may be dimensioned with a width Wcthat is wide enough to distribute the force(s) acting on the target surface such that the porous fixation extension 100 does not cut or pull out of the target surface when acted upon by an internal or external force. In an exemplary embodiment, the width Weof a fixation extension 100 may be between 2mm and 15mm wide. Some embodiments, however, may have a width Wethat is less than 2mm or more than 15mm. For example, the width Weof a fixation extension 100 may be 0.5mm, 1mm, 1.5mm, 20mm, 40mm, 60mm, 80mm, or any other width Wesuitable for the intended use of said fixation extension 100, including widths Wethat are more or less than the enumerated widths W, and widths Wethat are between any of the enumerated widths We. The fixation extensions 100 may likewise be spaced at various spacing distances Se(FIGS. 6A-6C) and in various ways around the base section.

[0060] In some embodiments, the thickness Teof a fixation extension 100 may be between 0.1mm and 2mm. Some embodiments, however, may have a thickness Tethat is less than 0.1mm or more than 2mm. For example, the thickness Teof a fixation extension 100 may be 0.02mm, 0.04mm, 0.06mm, 0.08mm, 4mm, 6mm, 8mm, 10mm, or any other thickness Tesuitable for the intended use of said fixation extension 100, including thickness Tethat is more or less than the enumerated thickness Te, and thickness Tethat is between any of the enumerated thicknesses Te.

[0061] In some embodiments, the length Leof the fixation extension 100 may be related to the width Weof the fixation extension 100. That is, the fixation extension 100 may be configured with length and width dimensions selected based on a desired length-to-width aspect ratio (L:W) of the fixation extension 100. In an exemplary embodiment, a fixation extension 100 may be dimensioned to have a length-to-width aspect ratio that is at least 10 to 1 (10:1). For example, a fixation extension 100 may be 50mm long and 5mm wide (10:1), 100mm long and 5mm wide (20:1), 100mm long and 2.5mm wide (40:1), 1000mm long and 15mm wide (66.66:1), 1000mm long and 2mm wide (500:1), and / or any other combination of lengths and widths that results in an aspect ratio that is greater than 10 to 1, including aspect ratios that are between any of the enumerated aspect ratios. Some embodiments, however, may have an aspect ratio that is less than 10 to 1. For example, a fixation extension 100 may be 100mm long and 15mm wide (6.66:1), 50mm long and 10mm wide (5:1), 50mm long and 15mm wide (3.33:1), and / or any other combination of lengths and widths that results in an aspect ratio that is less than 10 to 1, including aspect ratios that are between any of the enumerated aspect ratios.

[0062] As previously mentioned, embodiments of a porous fixation extension 100 may be configured with pores 120, 122 that are dimensioned and / or arranged in the fixation extension body 102. The pores may be sized and shaped so that the fixation extension 100 may be passed through itself via the pores 120, 122 to anchor the fixation extension 100 to the target surface. In some embodiments, the dimensions of the pores 120, 122 may be based on at least one of the dimensions of the fixation device(s) 114; the length Le, width We, and / or thickness Teof the fixation extension body 102; the properties of the material(s) that form the porous fixation extension 100; the properties of the target surface; the arrangement of pores 120, 122 in the fixation extension body 102; and any other parameter or characteristic of the porous fixation extension 100.

[0063] In some embodiments, the spacing between the pores 120, 122 may be based on at least one of the dimensions of the fixation device(s) 114; the length Le, width We, and / or thickness Teof the fixation extension body 102; the diameter of the pores 120, 122; the properties of the material(s) that form the porous fixation extension 100; the properties of the target surface; and any other parameter or characteristic of the porous fixation extension 100. In an exemplary embodiment of a porous fixation extension 100, the pores 120, 122 may be spaced between 0.5mm and 20mm apart, center-to-center. For example, at least two adjacent pores 120, 122 may be spaced 5mm apart. Some embodiments, however, may be configured with at least two adjacent pores 120,122 that are less than 0.5mm apart and / or more than 20mm apart. For example, at least two adjacent pores 120, 122 may be 0.1mm apart, 0.25mm apart, 30mm apart, 50mm apart, 100mm apart, and / or any other suitable distance, including distances that at are more or less than the enumerated distances, and distances that are between any of the enumerated distances.

[0064] Additionally or alternatively, the size, spacing, and / or arrangement of the pores 120, 122 may vary along the length Leand / or width Weof the fixation extension body 102. For example, an embodiment of a porous fixation extension 100 may be configured with pores 120, 122 that are more densely arr anged at different locations on the porous fixation extension 100. The fixation extension body 102 may include a concentration of pores 120, 122 at locations where the porous fixation extension 100 will be passed through itself and a low density of pores 120, 122 at other locations where the porous fixation extension 100 will not be passed through itself. For example, a fixation extension body 102 may include a plurality of the pores 120, 122 proximate the interior end 104 and / or the distal end 106 and have zero or relatively few pores 120, 122 in a middle portion of the fixation extension body 102. This may be useful, for example, to provide a plurality of possible locations and options for passing the porous fixation extension 100 through itself near' where an anchoring stitch may be formed or where increased tissue ingrowth is desired, while omitting pores 120, 122 at other locations where they are not needed, or where a stronger and / or more rigid length of fixation extension may be desired or needed or less tissue ingrowth is desired. Alternatively, the fixation extension body 102 may include a concentration of pores 120, 122 some or all of the middle portion of the fixation extension length Le, such as for applications where the porous fixation extension 100 will be passed through itself to create anchoring points that are likely to align with that center section or to reduce foreign body material. Alternatively or additionally, the pore size may vary along the length Leof the fixation extension body 102. For example, the pores 120, 122 at or most proximate the interior end 104 and / or the distal end 106 may be larger than the pores 120, 122 in the middle portion to enable initial anchoring of the proximal end of the porous fixation extension 100.

[0065] In addition or as an alternative to varying along the longitudinal length of a porous fixation extension 100, the pore density and / or pore size may vary across the lateral width of the fixation extension body 102 between the opposing lateral sides 108, 110 thereof. For example, along at least a portion of a porous fixation extension 100, the pores 120, 122 may be offset from the lateral midpoint of the fixation extension body 102 so that pores 120, 122 are includedproximate one or both of the lateral sides 108, 1 10 and omitted or less densely arranged along the lateral centerline of the fixation extension body 102. In the case of a porous mesh fixation extension 100, a portion of the fixation extension body 102 may be configured with the central pores 120 omitted while the lateral pores 122 are still included. In some embodiments of a porous mesh fixation extension 100, the density of the pores 120, 122 may be increased by more tightly weaving, sowing, and / or braiding the textile strands 130 and the density of the pores 120, 122 may be decreased by more loosely weaving, sowing, and / or braiding the textile strands 130. The pores may be configured to constrict when the fixation extension is put under tension thereby tightening around the porous fixation extension where it passes through itself.

[0066] It should be appreciated that other lengths Le, widths We, thicknesses Te, aspect ratios, pore sizes, pore shapes, and / or materials are contemplated as within the scope of disclosure, and one of skill in the art will appreciate that various dimensions, materials and configurations may be appropriate depending on various parameters, such as the tissue defect or reconstruction and surgical approach by which the porous fixation extension 100 will be applied.

[0067] In the embodiments of FIGS. 1-3, the base section 51 of the harness 50 has a generally semicircular' shape. Some embodiments of a semicircular harness 50 may be formed from a larger sheet of material, such as by cutting a large shape formed of a woven mesh into two or more pieces. Referring to FIGS. 6A through 7, a large mesh body 48 may be configured to be separated into two mesh harnesses 50. The mesh body 48 may be a unitary woven piece containing a base section 51a, 51b, 51c and multiple fixation extensions 100 extending therefrom, wherein the mesh body 48 is configured such that it can be divided into two or more pieces. In one embodiment, the mesh body 48 is configured such that it can be used as an implantable harness that covers the entirety of the breast shaping element, or can be divided into two or more pieces to create harnesses that each cover a portion of the breast shaping element. The mesh body 48 shown in FIG. 6A is symmetrical across a midline 49. Dividing the mesh body 48 along the midline 49, such as by cutting, forms two mesh harnesses 50 that are generally the same in shape and size (e.g., each having a semi-circular- shape with height Hh) and each include five pairs of fixation extensions 100 extending from their corresponding lateral edges 56, 58. Additionally or alternatively, the mesh body 48 may be used as a single harness configured with a circular base section.

[0068] FIGS. 6B and 6C show alternative mesh body configurations 48b and 48c, each being symmetrical about its centerline. The fixation extensions 100 may be spaced at variousspacing distances Se(FIGS. 6A-6C) and in various ways around the base section. The fixation extensions 100 may be consistently distributed around the base section such that the spacing distance Seis equal between various fixation extensions 100, like that shown in FIGS. 6A and 6C. Alternatively, the spacing distances between adjacent fixation extensions 100 may vary. FIG. 6B shows an example where the fixation extensions 100a and 100b closest to the midline 49b have the shortest spacing distance Sei (which is mirrored on both lateral sides). The remaining fixation extensions are spaced further apart. The spacing distance Se2 between fixation extensions 100b and 100c is significantly larger. For example, spacing distance Se2 is at least two times spacing distance Sei. This provides two fixation extensions 100a and 100b close to the midline 49b, which can be useful for fixation where extra support is needed along the center portion of the breast shaping element. Where the mesh body 48b is divided (e.g., cut) along the midline 49b, the closely-spaced fixation extensions 100a and 100b provides for each piece 24a and 24b to have a fixation extension near’ the top of the respective base section 51bl, 51b2.

[0069] The mesh body configuration may be a different shape other than a circle. FIG. 6C shows a mesh body configuration 48c wherein the base section 51c has a graduated edge. The peripheral edge of the base section 51c varies. The edge portion 59a between some of the fixation extensions 100 is straight (perpendicular to the fixation extensions 100). The edge portion 59b between others of the fixation extensions 100 is angled so as to step in the width of the base section 51c as it gets further from the midline 49c. The angled edge portions 59b may be curved between adjacent fixation extensions (as shown) or may be straight.

[0070] In FIG. 7, the large mesh body 48 is shown with the fixation extensions 100 in a stored configuration where they are wound in a holding apparatus 38. A fixation device 114 for anchoring the harness 50 to a target surface, such as a surgical needle, is fixed to the distal end of each fixation extension 100.

[0071] Referring to FIGS. 8-10, as previously mentioned, the harness 50 can be anchored to a target surface 90 to support the breast shaping element 40 by clamping the breast shaping element 40 between the base section 51 and the target surface 90. To anchor the harness 50 on the target surface 90, each fixation extension 100 can be passed through the target surface at least once.

[0072] Referring to FIG. 8, the harness 50 and the breast shaping element 40 may be moved into the desired position on the target surface 90 before anchoring the harness 50 thereto. Someembodiments, however, may include fixation extensions 100 that are dimensioned with a length Lethat is sufficiently long so that the fixation extensions 100 can be engaged with the target surface 90 before the base section 51 of the harness 50 and / or the breast shaping element 40 are moved into the desired position on the target surface 90. In the embodiment of FIG. 8, the harness 50 includes five fixation extensions 100 extending from each lateral edge 56, 58 of the base section 51 similar to the harness 50 of FIGS. 1-3. When the harness 50 is placed on the breast shaping element 40, the semicircular base section 51 generally covers the lower portion of the anterior side of the breast shaping element 40. The lateral edges 56, 58 and the lower edge 54 of the base section 51 wrap around the sides of the breast shaping element 40 towards the target surface 90, thereby conforming the base section to the surface of the breast shaping element 40.

[0073] As also illustrated in FIGS. 9 and 13, at least a portion of a lateral edge 56, 58 or the lower edge 54 may extend around the corresponding side of the breast shaping element 40 so that a portion the base section 51 extends around said side to the posterior side of the breast shaping element 40. Conforming the harness 50 to the breast shaping element 40 may adjust the orientation of at least one of the fixation extensions. As illustrated in FIGS. 8 and 9, the fixation extensions 100 generally align themselves relative to the breast shaping element 40 such that the fixation extensions 100 extend radially outward from the sides of the breast shaping element 40. The lower fixation extension 100 on each lateral edge 56, 58 (i.e., the fixation extensions 100 adjacent the lower edge 54) may be reoriented to extend vertically downward in a direction that may be generally perpendicular to their original orientation, or downward-extending fixation extensions may be added in addition to the fixation extensions 100 adjacent the lower edge 54. The upper fixation extension 100 on each lateral edge 56, 58 (z.e., the fixation extensions 100 adjacent the upper edge 52) retain their original orientation.

[0074] Referring to FIG. 9, the fixation devices 114 at the distal end 106 of each fixation extension 100 (see, e.g., FIG. 3) are used to pierce the target surface 90 so the fixation extensions 100 can be pulled through the target surface 90. Each of the fixation extensions 100 is passed into the target surface 90 and subsequently pulled out of the target surface 90 at a corresponding bite 91. The initial bite 91 at which each fixation extension 100 is engaged with the target surface 90 is positioned proximate the edge 54, 56, 58 of the base section 51 from which each fixation extension 100 extends. When a fixation extension 100 is engaged with the target surface 90 at a single bite 91, the body 102 of the fixation extension can slide within the bite 91 to loosen ortighten the harness 50 on the target surface 90. This may he useful, for example, to adjust the location of the harness 50 and / or the breast shaping element 40 before securing the harness 50 and the breast shaping element 40 in the desired final position.

[0075] Once the harness 50 and the breast shaping element 40 are in position relative to the desired position of the breast shaping element 40, the fixation extensions may be passed through the target surface 90 at least one additional time to securely anchor the harness 50 to the target surface 90, as illustrated in FIG. 10. The distal ends may then be cut to remove the excess length, forming cut ends 106a. In this configuration, the harness 50 supports the breast shaping element 40 such that the breast shaping element 40 is suspended from the target surface 90.

[0076] Advantageously, the plurality of pores 120, 122 arranged along the bodies 102 of the fixation extensions 100 allow the distal end 106 of each fixation extension 100 to be pulled through a pore 120, 122 formed in the body 102 of said fixation extension 100, thereby engaging the fixation extension 100 with its own body 102 to form a self-locking stitch. FIGS. 11A-11D and 12A-12D illustrate exemplary methods of anchoring the porous fixation extensions 100 of an implantable porous harness 50 to a target surface. While FIGS. 11A-11D, and 12A-12D illustrate the use of a mesh fixation extension 100 (see, e.g., FIG. 4), it should be appreciated that the illustrated procedures may also be used with a fixation extension having a generally solid or dense sheet body, such as the porous fixation extension 200 of FIG. 1.

[0077] FIGS. 11A-11D illustrate a self-locking stitch 190 for anchoring a mesh fixation extension 100 with a fixation device 114 at a distal end 106 thereof to a target surface 90. As illustrated in FIG. 11 A, the fixation device 114 at the distal end 106 of the fixation extension is passed into the target surface 90 at a first bite entry 94 and back out of the target surface 90 at a first bite exit 95 spaced laterally from the first bite entry 94. This process is repeated by passing the fixation device 114 into and out of the target surface 90 at a second bite entry 96 and a second bite exit 97, as illustrated in FIG. 11B, and again by passing the fixation device 114 into and out of the target surface 90 at a third bite entry 98 and a third bite exit 99, as illustrated in FIG. 11C. The distal end 106 and the fixation device 114 attached thereto are then passed through a central pore 120 of the fixation extension 100 and back into the target surface 90 via the third bite entry 98. As illustrated in FIG. 1 ID, the fixation device is then passed back out of the target surface 90 via the third bite exit 99 and through a second central pore 120 proximate the third bite exit 99.

[0078] Referring to FIGS. 12A-12D, a porous fixation extension 100 with a fixation device 114 at a distal end 106 thereof may be passed through itself and a target surface 90 multiple times to create a self-locking backstitch 188 to anchor the fixation extension 100 to the target surface 90. As illustrated in FIG. 12A, the fixation device 114 at the distal end 106 of the fixation extension is passed into the target surface 90 at a first bite entry 94 and back out of the target surface 90 at a first bite exit 95 in the direction of arrow 180. The distal end 106 of the fixation extension 100 is then pulled out of the target surface 90 at the first bite exit 95 in the direction of arrow 182a until desired tension in the mesh 51 is achieved and brought back around towards the first bite entry 94, as illustrated in FIG. 12B. The fixation device 144 is then passed through a central pore 120 of the fixation extension 100 and back into the target surface 90 in the direction of arrow 182b via the first bite entry 94. The fixation extension 100 is then pulled up through the target surface 90 in the direction of arrow 182c at a second bite exit 97 located just beyond the first bite exit 95. In the illustrated embodiments, the second bite exit 97 is located approximately lmm-2mm beyond the first bite exit 95. In some embodiments, however, the second bite exit 97 may be located more than 2mm beyond the first bite exit 95 or less than 1mm beyond the first bite exit 95 or at or before the first bite exit 95. After the distal end 106 has been pulled to the desired tightness in the direction of arrow 184A through the second bite exit 97, the fixation device 114 is then passed in the direction of arrow 184b through a second centrally positioned pore 120 located between the first bite entry 94 and the first bite exit 95, as illustrated in FIG. 12C. Referring to FIG. 12D, the distal end 106 (FIG. 12A-12C) of the fixation extension 100 is drawn snug in the direction of arrow 186, thereby locking the loop in place to form the non-constricting self-locking backstitch 188. The fixation extension 100 may then be cut to remove the excess length on the distal end 106, forming cut end 106a, to remove the fixation device 114 and excess material from the fixation extension 100.

[0079] Embodiments of a porous fixation extension 100 may additionally or alternatively be anchored to a target surface using other fixation methods or weave patterns. For example, a fixation extension 100 may be woven into the target surface in a hitch pattern, an x- weave pattern, a locking x-weave pattern, a plus weave pattern, a longitudinal weave pattern, a varied longitudinal weave pattern, or any other suturing weave pattern.

[0080] Passing a fixation extension 100 through itself, as exemplified in FIGS. 11A-11D and 12A-12D and variously described herein, enables superior anchoring. Superior anchoring isenabled by the wider fixation extension width that distributes force, and also from the ability to pass the fixation extension through itself. Passing the fixation extension through itself to create a self-locking stitch provides a flatter and less bulky knot with fewer layers of crossed material compared to traditional knotting techniques. The self-locking stitch lays relatively flat to the tissue, providing a less palpable knot that is less likely to cause tissue erosion. Also, the flatter knots enabled by the porous fixation extension are less likely to harbor bacteria that causes infection and thus to reduce instances of “stitch abscesses” or other infections that occur with larger knots having more interstices that harbor bacteria.

[0081] In some embodiments, at least one fixation extension 100 may be passed through a pore 124 (FIG. 13) formed in the base section 51 to anchor the harness 50 to the target surface 90. For example, the device may only need a few extensions, such as two opposing extensions along either edge, which may then be used to sew along the perimeter of the implant to the target tissue. For example, referring to FIG. 13, a fixation extension 100a extending from the second lateral edge 58 may engaged and pass through the target surface 90 and is subsequently passed through a pore 124a formed in the base section 51 proximate the second lateral side 58. Using the fixation device 114a, the fixation extension 100a can be repeatedly passed through the target surface 90 and pores 124 arranged along or near a lateral edge 56, 58 and / or the lower edge 54 of the base section 51 to form a stitch pattern that anchors the harness 50 to the target surface 90 at a plurality of locations along the lateral or lower edge(s) 54, 56, 58. In some embodiments, for example, the upper fixation extension 100 on the first lateral edge 56 and the upper fixation extension 100 on the second lateral edge 56 may be repeatedly passed through the target surface 90 and pores 124 formed in the base section 51 to form a series of stitches that extend down both of the lateral edges 56, 58 to form a continuous stitch extending along each lateral edge 56, 58 from the upper edge 52 to the lower edge 54. In some embodiments, at least one of the fixation extensions 100 may be repeatedly engaged with the target surface 90 and the adjacent pores 124 along the lower edge 54, the first lateral edge 56, and the second lateral edge 58 to form a continuous stitch pattern along substantially the entire portion of the base section 51 .

[0082] As previously mentioned, embodiments of a harness configured to support a breast shaping element for a breast reconstruction and / or augmentation procedure may include a base section and / or at least one fixation extension that are different than those of the harness 50 of FIGS. 1-3 and 6-10. For example, a harness may be configured with a base second that is a differentshape and / or size than the base sections 51 of FIGS. 1-3 and 6-10. Additionally or alternatively, a harness may be configured with a different arrangement of fixation extensions for anchoring the harness to a target surface.

[0083] Referring to FIGS. 14A and 14B, some embodiments of a harness 150 may include a base section 151 that may be heat set into a convex shape that conforms to the anterior surface of a breast shaping element 40, or a desired shape for the breast shaping element (such as a desired shape for the patient’s native tissue). In other embodiments, the mesh body may be knitted or woven into a convex arc or semi-circular shape, or otherwise formed into an arc or convex shape. Similarly to the harness 50 of FIGS. 1-3, the harness 150 of FIGS. 14A and 14B includes a macroporous base section 151 extending vertically from an upper edge 152 to a lower edge 154 and a plurality of macroporous fixation extensions 100 extending outward from the lateral sides, such as from a perimeter, of the base section 151. However, unlike the harness 50 of FIGS. 1-3, the harness 150 of FIGS. 14A and 14B has multiple lateral edge segments 160-165 that are arranged in a stepped configuration that tapers inward from the lateral corners of the upper edge 152 to the lateral corners of the lower edge 154. At least one fixation extension 100 extends laterally outward in a corresponding first or second lateral direction from each of the stepped edge segments 160-165. In the illustrated embodiments the uppermost edge segments 160, 163 each include two fixation extensions 100 with interior ends 104 that are connected to the upper and lower edges of the uppermost edge segments 160, 163. The middle and lower edge segments 161, 162, 164, 165 each include one fixation extension 100 with an interior end 104 that is connected to the lower edges of the respective middle or lower edge segment 161, 162, 164, 165.

[0084] The illustrated base section 151 has been heat set into a three dimensional shape that curves in both the vertical and lateral directions. As illustrated in FIG. 14B, the heat set base section 151 closely follows the curvature of the anterior surface of the breast shaping element 40, thereby providing a snug fit between the harness 150 and the breast shaping element 40. As also illustrated in FIG. 14B, the stepped configuration of the lateral edge segments 160-165 cause the lateral sides of the heat set base section 151 to generally conform to the peripheral edges of the breast shaping element 40. This may be useful, for example, so that the harness 150 conforms to the breast shaping element 40 without any extra material.

[0085] In some embodiments, a harness 150 including stepped lateral edge segments 160- 165 may be initially manufactured with the stepped lateral edge segments 160-165. Someembodiments of a harness 150, however, may be modified from a different initial shape to include atlcastonc stepped edge segment 160-165. Referring to FIGS. 1-3, 14A, and 14B, a harness having differently shaped base section, such as the harness 50 of FIGS. 1-3, may be configured as a template harness that can be modified to form the harness 150 of FIGS. 14A and 14B. To form the harness 150 of FIGS. 14A and 14B from a template harness 50 with a semicircular' base section 51, the lateral edges 56, 58 of the template harness 50 may be modified, for example by cutting the base section 51, to have straight lateral edge segments 160-165 that step inward from the upper edge 52, 152 to the lower edge 54, 154. This may be useful, for example, so a clinician can customize an implantable porous harness 50 bases on the particular breast shaping element 40 that will be used with said harness 50. In the embodiment of FIGS. 14A and 14B, the bottom portion of the template base section 51 has been truncated to remove the original lower edge 54 and the lowermost fixation extensions, thereby forming the lower edge 154 of the modified base section 151. Some embodiments of a harness 150, however, may be formed with a different configuration of stepped lateral edge segments 160-165. For example, a harness may be formed with a lateral side that has at least one additional stepped lateral edge and / or a lateral side that has at least one fewer stepped lateral edges. Additionally or alternatively, the base section 51 of the template harness 50 may be truncated at the upper portion and / or the lower portion to achieve a desired height dimension of the modified base section 151.

[0086] Some embodiments of a harness may have a different configuration. Referring to FIGS. 15 and 16, an embodiment of a harness 250 with a generally semicircular base section 251 and additional fixation extensions may be formed, including upward-extending fixation extensions 265 and, in some embodiments, downward-extending fixation extensions 267. In the exemplary embodiment, the harness 250 includes a base section 251 with seven fixation extensions 100, 270 extending from the perimeter of the base section 251 in six different directions.

[0087] In one embodiment, to form the harness 250 of FIGS. 15 and 16, a template harness, such as the harness 50 of FIGS. 1-3, can be modified by relocating several fixation extensions 270 from their original locations. In the depicted embodiment, the vertical fixation extensions 270 were originally configured as fixation extensions 100 extending the lateral edges 56, 58 of the template base section 51 to the upper edge 252 and the lower edge 254 of the base section 251 of the modified harness 250. In particular, three fixation extensions 100 connected to the template base section 51 were separated (z'.e., cut) from at least one of the lateral edges 56, 58 and reattached tothe upper edge 252 and the lower edge 254. Two of the vertical fixation extensions 270, the upward-extending fixation extensions 265, arc secured to the upper edge 252 of the base section 251. One vertical fixation extension 270, a downward-extending fixation extension 267, is secured to the lower edge 254 of the base section 251 , which in other embodiments could instead be two or more downward-extending extensions centered around a lower midpoint of the lower edge 254. In other embodiments, the harness 250 with one or more upward-extending fixation extensions and / or downward-extending fixation extensions may be formed by other methods, such as cut as a single piece from a unitary piece of mesh. That is, in some embodiments, at least one upward- extending fixation extensions 265 and / or at least one downward-extending fixation extensions 267 may be integrally formed with the base section 251 of the implantable harness 250 as extensions of the mesh material forming the body of the base section 251.

[0088] In one embodiment, the two upward-extending fixation extensions 265 are positioned symmetrically relative to a lateral midpoint of the base section 251. In one such embodiment, the upward-extending fixation extensions 265 are located closer to the lateral midpoint 253 of the base section 251 than to either of the lateral sides of the base section 251. Similarly, the upward-extending fixation extensions 265 may be positioned closer to the lateral midpoint of the base section 251 than to an outer comer 255 of the upper edge 252. The distance between the midpoint 253 and each upward-extending fixation extension 265 may be proportional to the width of the breast shaping element 40 and / or to the width of the upper edge 252. For instance, the upward-extending fixation extensions 265 may be located at about 1 / 3 of the distance between the midpoint 253 and the outer corner 255, or in some configurations may be located at a point between 25% and 50% of the distance between the midpoint 253 and the outer comer 255. Due to their positions along the upper edge 252, the two upward-extending fixation extensions 265 pull up on the upper edge 252 to support the harness 250 and the breast shaping element 40. Thus, the harness 250 and the breast shaping element 40 are suspended, bearing at least a portion of the weight, from the two upward-extending fixation extensions 265. In various embodiments, a different number of upward-extending fixation extensions may be provided, which may be one upward-extending extension or may be three or more upward-extending extensions.

[0089] With continued reference to FIGS. 15 and 16, the downward-extending fixation extension 267 extending from the lower edge 254 of the base section 251 is positioned in alignment with the lateral midpoint of the base section 251. When the harness 250 and the breast shapingelement 40 are anchored to the target surface 90, the downward-extending fixation extension 267 supports the center of the lower edge 254. In some embodiments, the harness 250 may be anchored to the target surface 90 such that the downward-extending fixation extension 267 is engaged and anchored to the target surface 90 at a location which is behind the posterior side of the breast shaping element 40. In such an embodiment, the downward-extending fixation extension 267 pulls the lower edge 254 of the base section 251 around the breast shaping element 40 so that the downward-extending fixation extension 267 and the lower portion of the base section 251 support a bottom side of the breast shaping element 40. Additionally, when the base section 251 is conformed to the breast shaping element 40, the downward-extending fixation extension 267 may be engaged with multiple locations in the lower portion of the base section 251 which have been folded to overlap each other. Advantageously, such a downward-extending fixation extension 267 can hold the overlapping portions of the base section 251 together to retain the conformed shape of the base section 251.

[0090] While the vertically extending fixation extensions 270 of FIGS. 15 and 16 are described as being separated from the template base section 51 and relocated to a new position, it should be appreciated that some embodiments of a harness 250 may include at least one fixation extension that has been attached to the modified base section 251, but which was not originally part of the template harness 50. For example, at least one separate fixation extension may be coupled to the perimeter of the base section 251 to add an additional fixation extension.

[0091] To connect a relocated (or independent) attachable fixation extension (e.g., as one way of forming the vertical fixation extensions 270 of FIGS. 15 and 16) to the upper or lower edge of a base section and / or another section of mesh material (e.g., the base section 251 of the implantable harness 250 of FIGS. 15 and 16), the body of the attachable fixation extension can be passed through and engaged with a pore formed in the mesh material . The connection between the attachable fixation extension and the mesh material can be made using a variety of knots and / or stitching techniques. FIGS. 25A-25D illustrate exemplary methods of anchoring an attachable fixation extension 290 to a perimeter edge 232 of a mesh sheet 230 with a self-locking stitch.

[0092] Referring to FIGS. 25A-25D, an attachable fixation extension 290 with a fixation device 114 at a first end 292 thereof may be passed its own body 291 near the edge 232 of the mesh sheet 230 to create a clinch knot 178 in order to anchor the attachable fixation extension 290 to a location on the perimeter edge 232 of the mesh sheet 230. As illustrated in FIG. 25A, thefixation device 1 14 at the first end 292 is passed through a pore 234 proximate the edge 232 of the mesh sheet 230 in the direction of arrow 170. As illustrated in FIG. 25B, the fixation device 114 is then passed through a central pore 296 proximate the second end 294 of the attachable fixation extension 290 in the direction of arrow 172. (Note: in FIG. 25B, the first end 292 of the fixation extension 290 is obscured by the positioning instrument used to manipulate the fixation extension 290). The attachable fixation extension 290 is then pulled by the first end 292 through the central pore 296 in the direction of arrow 174 to create a loop, as illustrated in FIG. 25C. The attachable fixation extension 290 is then pulled tight in the direction of arrow 176, as illustrated in FIG. 25D, to clinch the knot onto the upper edge 232, thereby securing the attachable fixation extension 290 to the mesh sheet 230 with a clinch knot 178 formed proximate the second end 294 of the attachable fixation extension 290.

[0093] Embodiments of an attachable fixation extension 290 may, additionally or alternatively, be anchored to an edge 232 of a mesh sheet 230 using other fixation methods or weave patterns. Additionally or alternatively, at least one attachable fixation extension 290 may be connected to a mesh sheet at a pore or pores 234 that is not located proximate the perimeter edge 232 of the mesh sheet 230.

[0094] While the harnesses 150, 250 of FIGS 14A-16 are depicted as being modified from a harness template 50 with a semicircular base section 51, it should be appreciated that the harnesses 150, 250 of FIGS 14A-16 (as well as the harness 50 of FIGS. 1-3) may be formed from a different template harness or a macroporous sheet of material configured as a template. This may be useful, for example, so that a clinician can customize the shape, size, and orientation of the base section and / or the fixation extensions based on the breast shaping element 40. As illustrated in FIGS. 17 and 18, some embodiments of a harness 350 having a base section 351 and a plurality of fixation extensions 100 may be formed by modifying a mesh sheet 148 having a plurality of pores formed throughout. The porous harness 350 of FIGS. 18 and 19 is configured to wrap around a breast shaping element 40 to encapsulate at least a portion of the anterior and posterior sides of the breast shaping element 40. It should be appreciated, however, that any of the harnesses 50, 150, 250 of FIGS. 1-3 and 14A-16 may be formed from a sheet 348 of macroporous material.

[0095] Referring to FIGS. 17 and 18, embodiments of a porous harness 350 may include a base section 351 with a centrally positioned anterior portion 353 and a plurality of articulating petals 352, 354, 356 arranged around the anterior portion 353. The petals 352, 354, 356 each havea body which extends radially outward from a peripheral edge of the anterior portion 353 of the base section 351 to a distal end of the petal 352, 354, 356, which is connected to a fixation extension 100, 270. As discussed in greater detail below, the petal 352, 354, 356 are configured to be wrapped around the sides of the breast shaping element 40 to cover the posterior side of the breast shaping element 40.

[0096] Each petal 352, 354, 356 may terminate with one or more continuing fixation extensions 100, 270 with an attached fixation device at the end (e.g., a surgical needle). The fixation extension 100, 270 can be continuous with the petals and / or attached. Each fixation extension can be used (or removed) at the discretion of the surgeon to attach to the opposing petal and / or used to anchor to the surrounding tissue. For example, the width of the flat fixation extensions would be to 2mm to 8mm. The attached sutures give the surgeon flexibility in anchoring the implant and additional ability to reconstruct the IMF, close seams between petals, parachute the implant in, etc.

[0097] With continued reference to FIGS. 17 and 18, the illustrated base section 351 includes eight petals 352, 354, 256 spaced around the anterior portion 353. Four of the petals 352 are configured as elongated petals 352 that are spaced ninety degrees apart from each other and have an elongated body compared to the other, shorter petals 354, 356. A shorter petal 354, 356 is positioned between each of the elongated petals 352. In an alternative embodiment, all the petals may be the same length. In the orientation of the harness 350 depicted in FIGS. 17 and 18, two lateral petals 354 extend laterally from the anterior portion 353 and two vertical petals 354 extend vertically from the anterior portion 353. The elongated petals 352 and the lateral petals 354 are each connected to a fixation extension 100 extending in a first or second lateral direction from their respective distal ends. The elongated and lateral petals 352, 354 are integrally connected to the corresponding one of the fixation extensions 100 such that the base section 351 and the laterally extending fixation extensions 100 are formed from a continuous sheet 348 of macroporous material, for example a mesh sheet as illustrated in FIG. 18. Each of the vertical petals 356 is connected to an upward-extending fixation extension 265 or a downward-extending fixation extension 267. In the embodiment of FIGS. 17 and 18, the upward-extending fixation extensions 265 and the downward-extending fixation extension 267 are configured as relocated vertical fixation extension 270, which are secured to a distal end of said petal 356. The relocated vertical fixation extensions 270 may be secured to the distal end of a vertical petal 356 by engaging a poreformed in the body of the vertical petal 356, for example using the self-locking stitch illustrated in FIGS. 25A-25D. The use of a relocated vertical fixation extension 270 (or any other relocated fixation extensions) allows for a harness 350 to be formed from a sheet of material that is elongated in the lateral direction and has a width dimension corresponding to the vertical dimension of the harness 350 (i.e., the distance between the distal ends of the vertical petals 356). This may be useful, for example, to reduce the waste material from the process of manufacturing the harness 350 and / or to allow customizability of the implantable harness for a particular patient and application. In some embodiments, the harness 350 with one or more upward-extending fixation extensions 265 and / or downward-extending fixation extensions 267 may be formed by other methods, such as cut as a single piece from a unitary piece of mesh. That is, in some embodiments, at least one upward-extending fixation extensions 265 and / or at least one downward-extending fixation extensions 267 may be integrally formed with the base section 351 of the implantable harness 350 as extensions of the mesh material forming the body of the base section 351.

[0098] As previously mentioned, the harness 350 of FIGS. 17 and 18 is configured to wrap around and encapsulate the anterior and posterior sides of the breast shaping element 40. Referring to FIGS. 19-22, steps for encapsulating a breast shaping element 40 in a porous harness 350 are illustrated. Referring to FIG. 19, a breast shaping element 40 is positioned on the base section 351 such that the anterior side of the breast shaping element 40 rests on the anterior portion of the base section 351. The petals 352, 354, 356 and the fixation extensions 100, 270 attached thereto may then be wrapped around the breast shaping element 40 to encapsulate it in the harness 350.

[0099] Referring to FIGS. 20 and 21, each petal 352, 354, 356 can be wrapped around the sides of the breast shaping element 40 to cover the posterior side of the breast shaping element 40. Each petal 352, 354, 356 is conformed to the breast shaping element 40 such that the petal 352, 354, 356 and / or the fixation extension 100, 270 connected thereto is engaged with the diametrically opposed petal 352, 354, 356 and / or the fixation extension 100, 270. As illustrated in FIG. 20, the two opposing lateral petals 354b, 354e are wrapped around the sides of the breast shaping element 40 and the fixation extensions 100b, lOOe connected thereto extend across the posterior side of the breast shaping element 40 such that the fixation extensions 100b, lOOe extend past the opposing edge of the breast shaping element 40. The fixation extensions 100b, lOOe may be engaged with each other and / or the opposing lateral petal 354b, 354e to hold the lateral petals 354b, 354a in the wrapped position. For example, the fixation extensions 100b, lOOe each pass through a pore(s) inthe lateral petal 354b, 354e at a connection site 362 proximate the distal ends of the lateral petals 35b, 354c. Similarly, the vertical petals 356g, 356h arc wrapped around the edges of the breast shaping element 40 such that the upward-extending fixation extension 265g and the downwardextending fixation extension 267h extends across the posterior side of the breast shaping element 40, transversely relative to the lateral fixation extension 100b, lOOe, to engage a pore at a connecting site 362 proximate the distal end of the opposing vertical petal 356g, 356h. Thus, once the vertical petals 356g, 356h are conformed to the breast shaping element 40, the originally upward-extending fixation extension 265g extends downward across the breast shaping element 40 and past the lower edge thereof and the originally downward-extending fixation extensions 267h extends upward across the breast shaping element 40 and past the upper edge thereof

[0100] Referring to FIG. 21, the elongated petals 352a, 352c, 352d, 352f arc similarly wrapped around the sides of the breast shaping element 40 and the fixation extensions 100a, 100c, lOOd, lOOf connected thereto extend transversely across the breast shaping element 40 to engage the opposing one of the elongated petals 352a, 352c, 352d, 352f. Each fixation extension 100a, 100c, lOOd, lOOf is passed through a pore(s) in the opposing elongated petal 352a, 352c, 352d, 352f at a location 364 proximate the connection between the anterior portion 353 and said elongated petal 352a, 352c, 352d, 352f. Engagement between the fixation extensions 100, 270 and an opposing petal 352, 354, 356 advantageously holds the harness 350 in a wrapped configuration (FIG. 22) that conforms to and encapsulates substantially the entire anterior and posterior sides of the breast shaping element 40. In some embodiments, at least one of the fixation extensions 100, 270 may engage a pore formed in another one of the fixation extensions 100, 270, for example at a midpoint 360 on the posterior side of the breast shaping element 40, to retain the harness 350 in the wrapped configuration, and / or to distribute the forces applied to the harness 350 and the target surface 90 when supporting a breast shaping element 40.

[0101] While the embodiments of FIGS. 20 and 20 depict the lateral and vertical petals 354, 346 being wrapped around the breast shaping element 40 before the elongated petals 352, it should be appreciated that the petals 352, 354, 356 may be wrapped around the breast shaping element 40 in any order to encapsulate the breast shaping element 40 in the harness 350 and the petals may be of varying or similar length and shape compared to one another to provide encapsulation.

[0102] The use of fixation extensions which are substantially longer than the body of the base section of a harness advantageously allows a clinician to secure the harness to the target surface without first moving the harness and the breast shaping element supported therein into their final positions of the target surface. Referring to FIGS. 23 and 24, steps for anchoring a harness 350 and a breast shaping element 40 to a target surface 90 using a “parachuting” method are illustrated.

[0103] As illustrated in FIG. 23, fixation extensions 100 on the upper side of the harness 350 are passed through and engaged with the target surface at initial bite locations 391 that are located above the desired final position of the harness 350 and breast shaping element 40. The long length of the fixation extensions 100 allows a clinician to have a clear view of the target surface 90 when making the initial bites 391. Once the initial bites 391 have been made, the body 102 of the fixation extensions 100 may be pulled through the initial bites 390 by their distal ends 106 to pull the harness 350 and the breast shaping element 40 into position on the target surface 90, as illustrated in FIG. 24. Once the harness 350 and the breast shaping element 40 are in the desired position of the target surface 90, the unattached fixation extensions 100 are passed through the target surface 90 at secondary bite locations 392 located around the perimeter of the harness 350 and breast shaping element 40. The fixation extensions 100 may then be secured to the target surface 90 at or near the respective bite location 391, 392, for example using a self-locking stich pattern of FIGS. 11A-12D, to anchor the harness 350 and the breast shaping element 40 to the target surface.

[0104] In embodiments where the harness is configured to be used to pull the breast shaping element into place, at least a portion of the fixation extensions may have a long length configured to reach the initial bite location(s) 391 while the base section 51 remains outside of the patient’s body. For example, at least a subset of the fixation extensions 100 may be at least 15 cm and up to 50 cm. In some embodiments, a portion of the fixation extensions 100 are longer than the others and configured to enable the method shown in FIGS. 23 and 24, where those longer fixation extensions are configured to be used to be passed through the initial bite locations and then to pull the based section 51 and the breast shaping element into place. In some implementations, at least the longer subset of the fixation extensions 100 may be at least 20 cm, at least 25 cm, at least 30 cm, at least 35 cm, at least 40 cm, or at least 45 cm, and the remaining fixation extensions may be shorter, such as having 75%, 50%, or 25% of the length of the longerfixation extensions. In other embodiments, all of the fixation extensions 100 may have lengths in the above-described ranges.

[0105] In various embodiments, the fixation extensions 100 may be utilized to connect the harness 350 to muscle or fascia, such as in and around the pectoralis major and / or pectoralis minor, the serratus anterior, the rectus abdominus, and / or intercostal muscles / tissue to support the breast shaping element 40. Alternatively or additional, some portion or subset of the fixation extensions 100 may be utilized to connect to bone, such as to rib bone. Connection to bone may be via a screw or a tack. Alternatively or additionally, connection to bone may be by passing the extension through a hole formed in the bone or otherwise tying the fixation extension 100 to the bone, which may be passing the extension around and / or through the bone to which it is being fixed.

[0106] The steps illustrated in FIGS. 23 and 24 depict the attachment of harness 350 configured to encapsulate the anterior and posterior sides of the breast shaping element 40 (e.g., the harness 350 of FIGS. 17-22) to a target surface 90. Use of an encapsulating harness 350 allows for the harness 350 to be moved into position and anchored to the target surface 90 with the breast shaping element 40 held in the harness 350. It should be appreciated, however, that the steps of FIGS. 23 and 24 may be used to anchor a differently configured harness, such as the harnesses 50, 150, 250 of FIGS. 1-3 and 14A-16, to the target surface 90. In some implementations, the harness 50, 150, 250 may be pulled into position on the target surface without the breast shaping element 40, and the breast shaping element 40 may then be placed in the harness 50, 150, 250.

[0107] In FIGS. 1-3 and 14A-18, embodiments of an implantable porous harness 50, 150, 250, 350 are depicted in use with a breast shaping element 40 that has a generally hemispherical shape. However, embodiments of an implantable porous harness 50, 150, 250, 350 may be used with a differently shaped breast shaping element. For example, FIG. 26 illustrates an embodiment of a porous harness 450 configured to anchor and support a teardrop shaped breast shaping element 44 to a target surface 90. The base section 451 of the harness 450 may have a shape that conforms to at least a portion of the anterior and / or posterior side on the teardrop breast shaping element 44. Like the embodiments of FIGS. 1-3 and 14A-18, the harness 450 of FIG. 26 includes a plurality of fixation extensions 100 which engage the target surface 90 to support the breast shaping element thereon.

[0108] Some embodiments of an implantable porous harness 50, 150, 250, 350, 450 may include at least one biodegradable filament and / or textile strand configured to degrade over timeafter said biodegradable filament and / or textile strand is inserted into tissue or another target surface. In such an embodiment, the biodegradable filaments may hold tissue together while it heals before degrading when the additional filament is no longer needed. For example, an implantable porous harness 50, 150, 250, 350, 450 may include biodegradable barbed strands or at least some biodegradable filaments that are configured to hold tension in the fixation extension 100, 270 as it is inserted before degrading after insertion. In such an embodiment, the barbed fixation extension(s) strands may be configured to degrade entirely, or the barbs on the barbed strands or barb filaments may degrade while the body of the strand remains. Alternatively or additionally, the anterior surface of the mesh body may be barbed to provide further stability.

[0109] Embodiments of an implantable porous harness 50, 150, 250, 350, 450 may include different quantities, arrangements, and combinations of biodegradable filaments and / or textile strands. For example, some embodiments may be configured with between 25% and 75% biodegradable filaments and / or textile strands. Other embodiments, however, may be configured with less than 25% or more than 75% biodegradable filaments and / or textile strands. In some embodiments, at least one textile strand may include some biodegradable filaments and some non- biodegradable filaments. For example, a textile strand may include 50% biodegradable filaments and 50% non- non-biodegradable filaments. Other textile strands may be configured with less than 50% biodegradable filaments or more than 50% biodegradable filaments.

[0110] Some embodiments of an implantable porous harness 50, 150, 250, 350, 450 may include biodegradable filaments and / or textile strands at select locations, while non-biodegradable filaments and / or textile strands are included at other locations. For example, a porous mesh fixation extension 100, 270 may include at least one section of biodegradable strands or filaments that extend longitudinally across the base section 51, 151, 251, 351, 451 and / or a porous fixation extension 100, 270. Additionally or alternatively, at least one section of biodegradable filaments that extend laterally across the base section 51, 151, 251, 351, 451 and / or a porous fixation extension 100. In such an embodiment, the biodegradable filaments may be arranged in a pattern that results in a desired shape and / or size of the harness 50, 150, 250, 350, 450 once the biodegradable filaments degrade and the non-biodegradable filaments remain.

[0111] This written description uses examples to disclose the invention and to enable any person skilled in the art to make and use the invention. Certain terms have been used for brevity, clarity, and understanding. No unnecessary limitations are to be inferred therefrom beyond therequirement of the prior art because such terms are used for descriptive purposes only and are intended to be broadly construed. The patentable scope of the invention is defined by the claims and may include other examples that occur to those skilled in the ait. Such other examples are intended to be within the scope of the claims if they have features or structural elements that do not differ from the literal language of the claims, or if they include equivalent features or structural elements with insubstantial differences from the literal languages of the claims.

Claims

CLAIMSWhat is claimed is:

1. An implantable harness for supporting a breast shaping element on a target surface for a breast reconstruction or augmentation procedure, the harness comprising: a base section configured to conform to at least a portion of an anterior side of the breast shaping element; and a plurality of fixation extensions configured for anchoring to the target surface to support the breast shaping element thereon, each of the fixation extensions extending outward from a peripheral edge of the base section to a distal end; wherein the base section and the plurality of fixation extensions are formed from a macroporous material comprising a plurality of pores; and wherein the plurality of fixation extensions project outward from the base section in at least two different directions.

2. The implantable harness according to claim 1, wherein the breast shaping element is at least one of a breast implant and native tissue.

3. The implantable harness according to claims 1 or 2, wherein an outer edge of the base section is shaped to approximate a curvature of a lower side of the breast shaping element.

4. The implantable harness according to any one of claims 1-3, wherein the fixation extensions engage the target surface such that the breast shaping element is clamped between the base section and the target surface, thereby supporting the breast shaping element.

5. The implantable harness according to any one of claims 1-4, wherein the base section is configured to cover and engage at least a lower portion of the anterior side of the breast shaping element.

6. The implantable harness according to claim 5, wherein the base section is configured to cover at least a lower third of the anterior side of the breast shaping element.

7. The implantable harness according to any one of claims 1-6, wherein the base section also covers at least a portion of a posterior side of the breast shaping element to at least partially encapsulate the breast shaping element.

8. The implantable harness according to any one of claims 1-7, wherein the base section is formed in a convex shape.

9. The implantable harness according to any one of claims 1-8, wherein the base section is semicircular.

10. The implantable harness according to any one of claims 1-9, wherein each of the plurality of fixation extensions is dimensioned to be passed through the target surface multiple times to anchor the base section to the target surface.

11. The implantable harness according to claim 10, wherein each of the plurality of fixation extensions has a length dimension that is at least twenty times greater than a width dimension of said fixation extension.

12. The implantable harness according to any one of claims 1-11, wherein at least one fixation extension of the plurality of fixation extensions extends from the base section in a first direction and at least one other fixation extension of the plurality of fixation extensions extends from the base section in a second direction that is opposite the first.

13. The implantable harness according to claim 12, wherein a first fixation extension of the plurality of fixation extensions extends in a first direction, a second fixation extension of the plurality of fixation extensions extends in a second direction that is opposite and parallel to the first direction, and a third fixation extension of the plurality of fixation extensions extends in a third direction that is that is perpendicular to the first direction and the second direction.

14. The implantable harness according to claim 13, wherein the first direction is a first lateral direction, the second direction is a second lateral direction parallel and opposite the first lateral direction, and the third direction is a vertical direction that is perpendicular to the first lateral direction and the second lateral direction.

15. The implantable harness according to any one of claims 1-14, wherein the plurality of fixation extensions comprises at least two vertically extending fixation extensions that extend upward from an upper edge of the base section between opposing lateral sides of the base section.

16. The implantable harness according to claim 15, wherein the two vertically extending fixation extensions are symmetrically positioned relative to a lateral midpoint of the base section.

17. The implantable harness according to claim 15, wherein the two vertically extending fixation are positioned closer to the lateral midpoint of the base section than the lateral sides of the base section.

18. The implantable harness according any one of claims 1-17, wherein a pore on the base section is configured to have at least one of the plurality of fixation extensions passed therethrough and engage the pore to attached the at least one fixation extension to the base section.

19. The implantable harness according to any one of claims 1-18, wherein a distal end of at least one of the fixation extensions may be passed through at least one of the pores formed along a body of said fixation extension to engage said fixation with itself to form a self-locking stitch.

20. The implantable harness according to any one of claims 1-2, 4-8, or 10-19, wherein the base section comprises anterior section and a plurality of petals extending outwardly from a peripheral edge of the anterior section, the plurality of petals configured to wrap around at least a portion of a posterior side of the breast shaping element; and wherein the plurality of fixation extensions each extend outward from an outer end of one of the petals.

21. The implantable harness according to claim 20, wherein at least one of the plurality of fixation extensions is configured to interlock with at least one of a petal in the plurality of petals and a different one of the fixation extensions to retain the breast shaping element within the implantable harness.

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