WO2024242981A2

WO2024242981A2 - Implant fixation devices and related methods

Info

Publication number: WO2024242981A2
Application number: PCT/US2024/029597
Authority: WO
Inventors: Cassandra VANHAMME
Original assignee: Davol Inc
Current assignee: Davol Inc
Priority date: 2023-05-19
Filing date: 2024-05-16
Publication date: 2024-11-28
Anticipated expiration: 2025-11-19
Also published as: CN222854038U; WO2024242981A3

Abstract

Fixation devices for implants and related methods are generally described. A fixation device may be wrapped around the implant prior to delivery to reduce the risk of implant migration following implantation. The device may have porosity to induce tissue ingrowth around the implant and improve procedural outcomes. The device may be rapidly prepared and may accommodate a variety of implant sizes. In some embodiments, the device may include a central portion for covering an anterior surface of a breast implant and a peripheral portion for covering a posterior surface of the implant. The peripheral portion, which may include a continuous rim or a plurality of legs, may include tabs to secure the fixation device to an implant site. In some embodiments, a tether may be coupled to a distal portion of the peripheral portion, serving as a drawstring to rapidly wrap the device around an implant.

Description

IMPLANT FIXATION DEVICES AND RELATED METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application 63/503,453, filed on May 19, 2023, the content of which is incorporated herein by reference in its entirety.

FIELD

[0002] The present disclosure generally relates to the field of surgery, and more particularly, to implantable medical devices that limit the movement of breast implants following breast-related procedures, such as breast reconstruction, including augmentation mastopexy, breast augmentation, and breast revision surgery.

BACKGROUND

[0003] Breast reconstruction following mastectomy has become an integral and important part of breast cancer treatment with the surgery providing the patient with both aesthetic and psychosocial benefits. In the US, nearly 65% of breast reconstruction procedures now use a tissue expander to create a pocket for a permanent breast implant in the first step of the procedure. In some patients, a pocket for the breast implant can be formed without the use of a tissue expander. Once a pocket has been created, the tissue expander is removed, and replaced with a permanent breast implant in a second step.

[0004] Breast implants can also be used in breast augmentation and mastopexy procedures to augment breast size. In the latter procedure, a breast lift is combined with breast augmentation. Most commonly, the breast implant is placed in a pocket under the breast tissue, but in some cases, it is implanted under the chest wall. In some instances, breast implants are used in breast revision procedures, in which existing implants are swapped out for new implants. Revision procedures may take place if the existing implant was poorly positioned during the initial placement procedure, and/or if any long term complications arise following implantation.

[0005] Breast implants differ in dimensions, shape, and surface texture. A wide variety of different dimensions are available allowing the surgeon and patient to select from a range of projections, heights, widths and overall volume. In terms of shape, there are round and anatomically shaped implants, and the surfaces of the implants may be smooth, microtextured or macro-textured. Generally, round implants have smooth surfaces, whereas anatomically shaped implants have dimpled micro- or macro-textured surfaces.

SUMMARY

[0006] In some embodiments, implant fixation devices are disclosed. An implant fixation device to secure an implant in a patient may include a central portion sized and shaped to at least partially cover a first surface of the implant, and a peripheral portion extending radially away from the central portion, wherein the peripheral portion includes at least one tab that extends radially toward the central portion in a first orientation when the implant fixation device is in a first expanded configuration, and wherein the device is formed of a porous biocompatible material.

[0007] In other embodiments, implant fixation devices are disclosed. An implant fixation device to secure an implant in a patient may include a central portion sized and shaped to at least partially cover a first surface of the implant, a peripheral portion extending radially away from the central portion when the implant fixation device is in a first expanded configuration, and a tether coupled to the peripheral portion, the tether configured to be tensioned to draw the peripheral portion radially inwards to at least partially enclose the implant between the central portion and the peripheral portion when the implant fixation device is in a second wrapped configuration, wherein the device is formed of a porous biocompatible material.

[0008] In other embodiments still, methods of operating an implant fixation device are disclosed. A method of operating an implant fixation device includes positioning a central portion of the device to at least partially cover a first surface of the implant, wrapping a peripheral portion of the device to at least partially cover a second surface of the implant, the peripheral portion extending radially away from the central portion, moving one or more tabs attached to the peripheral portion from a first orientation oriented towards the central portion to a second orientation oriented away from the central portion, and securing the one or more tabs to an implant site.

[0009] In other embodiments still, methods of operating an implant fixation device are disclosed. A method of operating an implant fixation device includes positioning a central portion of the device to at least partially cover a first surface of the implant, and applying tension to a tether coupled to a peripheral portion of the device to draw the peripheral portion radially inwards to at least partially enclose the implant between the central portion and the peripheral portion when the implant fixation device is in a second wrapped configuration. [0010] It should be appreciated that the foregoing concepts, and additional concepts discussed below, may be arranged in any suitable combination, as the present disclosure is not limited in this respect. Further, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various nonlimiting embodiments when considered in conjunction with the accompanying figures.

BRIEF DESCRIPTION OF DRAWINGS

[0011] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures may be represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:

[0012] FIG. 1 shows an exemplary breast implant;

[0013] FIG. 2 shows one embodiment of an implant fixation device;

[0014] FIG. 3 shows three embodiments of an implant fixation device for use with different size implants;

[0015] FIG. 4 shows a back side view of an implant fixation device applied to an implant according to one embodiment;

[0016] FIG. 5 shows a front side view of an implant fixation device applied to an implant according to one embodiment;

[0017] FIG. 6 shows one embodiment of an implant fixation device applied to an implant;

[0018] FIG. 7 shows two embodiments of an implant fixation device applied to different types of implants;

[0019] FIG. 8 shows another embodiment of an implant fixation device;

[0020] FIG. 9 shows a top view of an implant fixation device according to one embodiment; [0021] FIG. 10 shows a back side view of an implant fixation device applied to an implant according to one embodiment;

[0022] FIGs. 11 A-l ID show yet another embodiment of an implant fixation device;

[0023] FIG. 12 shows a top view of an implant fixation device according to one embodiment;

[0024] FIGs. 13A-13D show yet another embodiment of an implant fixation device;

[0025] FIG. 14 shows an exploded view of yet another embodiment of an implant fixation device;

[0026] FIGs. 15A-15B show an assembled view of the implant fixation device of FIG. 14; and

[0027] FIGs. 16A-16C show various views of a breast implant in the implant fixation device of FIGs. 14-15B.

DETAILED DESCRIPTION

[0028] A growing number of patients considering breast reconstruction and augmentation are reluctant to have permanent breast implants placed in their breasts. This is particularly the case for women that have had a mastectomy and are now considering breast reconstruction. When used independently, conventional breast implants, formed of permanent non-absorbable materials such as silicone, pose risks of complications including potential capsular contraction, rupture or deflation of the implant, and development of anaplastic large cell lymphoma (ALCL).

[0029] Furthermore, due to the interactions between the permanent implants and the surrounding fascia, conventional implants may not be fixed in place following implantation, which increases the risks of migration or movement over time. For example, a permanent breast implant can rotate following implantation, resulting in an unnatural appearance of the breast. In some instances, the implant can migrate following implantation, causing asymmetry and disfigurement of the patient anatomy. Many of these complications may need a procedure to correct, which may be costly and undesirable in addition to the accumulation of scar tissue and delayed healing.

[0030] In some cases, the implantation of the implants could also pose complications. For example, during the implantation procedure, the implants can come into contact with the incision site and undesirably contaminate the implant with blood or other viscera from the incision site. In some instances, contact between the implant and the incision site may induce improper healing of the incision or implant site, which may reduce the flow of blood to the site and result in tissue necrosis.

[0031] More recently, permanent breast implants have been covered with an implant wrap prior to delivery to facilitate tissue ingrowth around the permanent implant to reduce the likelihood of the complications noted above. The inventors have recognized that existing wraps may require a surgeon to customize the shape and size to the desired permanent implant shape and size prior to implantation. This customization can take a skilled surgeon on the order of an hour in the operating room, prolonging the procedure time and therefore increasing costs and undesirable outcomes. In addition, the customization process may require tedious measuring and cutting of the wrap, which in turn requires significant contact with the implant prior to delivery to the implant site.

[0032] Furthermore, although not yet cleared for use in breast reconstruction procedures by the FDA, some surgeons may utilize wraps composed of acellular dermal matrix (ADM) materials, which can be derived from human tissue in the form of allografts, or from animal tissue in the form of decellularized xenografts. The inventors have recognized that such materials are not absorbable, which may present complications such as infection, necrosis, hematomas, and/or seromas. The inventors have also recognized that ADM materials are elastic and may result in breast implant displacement or disorientation over time. In some instances, the complications associated with ADM wraps may require followup procedures, such as implant revision.

[0033] In view of the above, the inventors have recognized the benefits associated with an implant fixation device which may be rapidly applied to an implant prior to delivery. The implant may significantly reduce the procedure time to improve procedural efficiency. Additionally, in some cases, the fixation device may be operated in a manner that minimizes contact with the implant prior to implantation. The fixation device may be formed of a porous biocompatible material that facilitates tissue ingrowth. Thus, the device may serve as a template for native cells, vasculature, and fluids to infiltrate through and form natural tissue around the implant. The fixation device may also be formed of an absorbable material, degrading over time as the natural tissue forms in place of the device. The absorbability of the fixation device may reduce the likelihood of foreign body reaction and rejection. However, instances in which different benefits are offered by the systems and methods disclosed herein are also possible.

[0034] In some embodiments, an implant fixation device may be formed of a porous biocompatible material, and may include a central portion configured to cover at least a portion of a first surface of an implant and a peripheral portion extending radially outward from the central portion that is configured to cover at least a portion of a second surface of the implant. In embodiments where the implant is a breast implant, the central portion may be arranged to cover the curved anterior or front surface of a conventional hemispherical breast implant, and the peripheral portion may be configured to cover the flatter posterior or back surface of the implant.

[0035] In some embodiments, the implant fixation devices disclosed herein may be arranged to move between a first expanded configuration to allow an implant to be placed against the central portion, and a second wrapped configuration in which the peripheral portion is wrapped around the back side of the implant. In some embodiments, this transition may occur with the help of a tether coupled to the peripheral portion. By applying tension to the tether through one or more handling portions, the tether may be able to bunch or gather the peripheral portion around the implant and form the wrapped configuration in which the implant fixation device extends at least partially, and in some instances completely around, an associated implant. The tether may function akin to a drawstring to wrap the fixation device conformally against the implant. This transition may occur with minimal contact between the surgeon and the implant, thereby reducing risks of contamination. The surgeon may be able to make this transition between fixation device configurations more rapidly than the conventional techniques of manually cutting and arranging implant wraps, which may improve procedural efficiency.

[0036] In some embodiments, a peripheral portion extending out from a central portion of an implant fixation device may include one or more tabs which can be secured to the implant site (e.g., the pectoralis muscle or chest wall of a patient) during implantation to help fix the orientation and position of the implant and fixation device assembly to the patient anatomy. The tabs may be formed radially across the peripheral portion, and may be oriented inwardly toward the central portion of the device along the portion of the peripheral portion the tabs are located on when the device is in the expanded configuration and the tabs are in a neutral unbiased configuration. During use, the tabs may be configured to be reoriented to point outwardly away from the central portion when the device is transitioned to its wrapped configuration. This reorientation of the tabs may occur due to the transition of the peripheral portion without any extra effort on behalf of the surgeon, though instances in which a surgeon or other user reorients the tabs manually are also contemplated. When the device is in a wrapped configuration around an implant, the tabs may extend away from the implant and device assembly, allowing the surgeon to easily identify the tabs (e.g., through visual inspection or palpation) and secure the assembly to the patient anatomy.

[0037] It should be appreciated that in some embodiments, the tabs may be oriented inwardly toward the central portion of the device when the device is in the expanded configuration. In other embodiments, the tabs may be oriented outwardly away from the central portion of the device when the device is in the expanded configuration. In other embodiments still, the tabs may be oriented at an angle relative to the radial direction of the peripheral portion. In other embodiments still, a combination of inwardly oriented, outwardly oriented, and angled tabs may be employed.

[0038] In some embodiments, the tabs may be formed from the body of the peripheral portion. For example, the tabs may be cut out from the peripheral portion, such that a portion of the tab may be freely moveable relative to the peripheral portion, and may be reoriented when the device is reconfigured between its expanded and wrapped configuration. In some embodiments, the tabs may be additional material attached to the peripheral portion through a suitable bonding technique, as described in greater detail below.

[0039] In some embodiments, the peripheral portion may include one or more legs extending radially outward from the central portion. The legs may be pre-cut or pre-formed to reduce preparation time, eliminating the need for a surgeon to manually cut or modify prosthetic fabric. The legs may be folded over the body of the implant during the wrapping process to conform against the implant. In embodiments where the fixation device includes tabs, each tab may be formed along a respective leg. In embodiments where the fixation device includes a tether, the tether may be coupled to a distal portion of one or more legs to facilitate the wrapping of the legs around the implant when tension is applied to the tether. The legs may be sized and shaped to provide sufficient coverage and support of the implant while reducing the likelihood of warpage and wrinkling on the implant. As will be described in greater detail below, the arrangement of the legs and the central portion may allow a fixation device to accommodate multiple implant sizes and shapes in a rapid manner without the need for excessive customization by the surgeon. Accordingly, a surgeon may be able to select from a small set of fixation device sizes (e.g., small, medium, large, extra-large), each of which may be able to accommodate a range of implant shapes and sizes. In some embodiments, the small set of devices may be able to accommodate at least 90% of the available conventional permanent implant sizes. In other embodiments, the set of devices may be able to accommodate at least 80% of available conventional permanent implant sizes. [0040] In some embodiments, the peripheral portion of an implant fixation device may be formed in the shape of a continuous rim that extends out from the central portion of the device and that extends at least partially, and in some instances completely, around a perimeter of the central portion of the device. The peripheral rim may function similarly to the legs, in that it may be wrapped around at least a portion of the implant to facilitate natural tissue ingrowth. In some embodiments, a tether may be coupled to a distal portion of the peripheral rim and may be tensioned to help transition the device from the expanded configuration to the wrapped configuration to conform against the implant.

[0041] As will be described in greater detail below, in some embodiments, a maximum diameter of the central portion may be smaller than a base diameter of an associated breast implant, such that wrapping the central portion around the implant may reduce the likelihood of wrinkles or warpage of the fixation device for a more desirable aesthetic outcome.

[0042] In some embodiments, the implant fixation device, including the central portion and the peripheral portion, may be provided in the form of a substantially two- dimensional patch body when in the expanded configuration. For example, the central portion and the peripheral portion may lie flat within a plane when the implant fixation device is disposed on a flat supporting surface in the expanded configuration in some embodiments. When the peripheral portion (e.g., a peripheral rim or one or more legs) is transitioned from the expanded configuration to the wrapped configuration around the implant, the device may be arranged in a three-dimensional configuration that extends conformally around at least a portion of the implant.

[0043] In some embodiments, the central portion of the fixation device may be provided in a substantially three-dimensional form. For example, the central portion may be pre-formed to mimic the curvature of the breast implant (and/or any other suitable implant), and may be shaped and sized to receive the implant therein. In some embodiments, the central portion may have a hemispherical shape. The curved central portion may allow the fixation device to conform against a breast implant to reduce the likelihood of wrinkles and warpage.

[0044] In some embodiments, the fixation devices of the present disclosure may be formed of a biocompatible prosthetic repair fabric, such as a porous mesh material. The pores of the mesh may induce tissue infiltration and growth of natural tissue around the implant. In some embodiments, the fixation device may be formed of a bio-absorbable material which may degrade while natural tissue is growing throughout the pores. In this way, the fixation device may be slowly replaced by native tissue. In other embodiments, the fixation device may be formed of a permanent material, and may exhibit porosity and/or texture to induce tissue growth on its surface.

[0045] In some embodiments, the various features (e.g., central portion, tabs, legs) of a fixation device may be formed from a sheet of repair fabric through any suitable means, including, but not limited to by die cutting, laser cutting, waterjets, hand-cutting, and/or any other suitable formation technique. In embodiments where portions of the fixation device are pre-formed in a three-dimensional shape, the repair fabric sheet may be formed using a thermal or compressive molding technique, as will be described in detail below.

[0046] The disclosed fixation devices may be used for a number of different applications, and may offer many different benefits. The fixation devices may be formed of a porous material to serve as a scaffold for tissue infiltration where tissue may grow into the device in some embodiments. The native tissue may serve as a natural shell around the implant and reduce the risks of capsular contracture and potential rejections of the foreign implant. In this way, complication risks may be reduced and surgical outcomes may be improved. Tissue in-growth may have an added benefit of resistance to migration, as the native tissue formed through the pores of the device may be grown from and/or fixed to the native anatomical space. The formation of native tissue formed at the implant site may further reduce the risk of foreign body reaction complications, such as capsular contracture. In some embodiments, the fixation devices may be wrapped around the implant and affixed to the surgical site in a manner that reduces the contact between the implant and the incision site through which the implant and device assembly is delivered. For example, the fixation device may shield the implant from viscera or fluids at the incision site for reduced risks of necrosis and contamination. In some embodiments, the fixation devices of the present disclosure may be configured to be rapidly wrapped around the implant to reduce the preparation and customization time in the procedure. Accordingly, the surgeon may be able to rapidly wrap the fixation device around a variety of implant types and shapes and ensure conformal wrapping with a reduced likelihood of wrinkling and warpage. In some embodiments, the fixation devices may be selectively transitioned between an expanded configuration and a wrapped configuration with limited contact between the surgeon and the implant. In this way, contamination and infection potential may be reduced. However, instances in which different benefits are offered by the systems and methods disclosed herein are also possible.

[0047] The fixation devices of the present disclosure may be formed of a biocompatible material which may promote rapid tissue or muscle in-growth into and around the device. In some embodiments, the fixation devices may be formed of an absorbable material that may be replaced in vivo by the patient’s natural tissue as the device degrades. [0048] In some embodiments, the device may be formed of an absorbable material (e.g., polymer or copolymer) that may be substantially resorbed after implantation within a 1 to 24-month timeframe, 3 to 18-month timeframe, and/or any other suitable timeframe. In some embodiments, the device may retain some residual strength for at least 2 weeks to 6 months, at least 12 weeks to 6 months, and/or any other suitable timeframe. It should be appreciated that the fixation devices of the present disclosure may retain residual strength through any suitable timeframe, depending on the operation and implant site.

[0049] In some embodiments, the fixation device may include an absorbable polymer comprising, or prepared from, one or more monomers selected from the group: glycolide, lactide, glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3 -hydroxybutyric acid, 3 -hydroxybutyrate, 4-hydroxybutyric acid, 4-hydroxybutyrate, s-caprolactone, 1,4- butanediol, 1,3-propane diol, ethylene glycol, glutaric acid, malic acid, malonic acid, oxalic acid, succinic acid, and adipic acid.

[0050] In some embodiments, the fixation devices may be formed of poly-4- hydroxybutyrate (P4HB) and copolymers thereof, or poly(butylene succinate) (PBS) and copolymers thereof. In embodiments, the P4HB and PBS polymers, and copolymers thereof, may not be crosslinked. In embodiments, the PBS polymer and copolymers may further include one or more of the following: branching agent, cross-linking agent, chain extender agent, and reactive blending agent. The PBS and P4HB polymers and copolymers may be isotopically enriched in some embodiments. [0051] The fixation devices of the present disclosure may be formed of a repair fabric material in the form of a mesh, a woven material, a nonwoven material, a knitted material, a braided material, a felted fabric, combinations thereof, and/or any other suitable types of repair fabric. In some embodiments, the repair fabric material may be porous to allow native biological material (e.g., fluids, cells, vasculature) to infiltrate the fixation device. The repair fabric material may be formed of nonlimiting exemplary materials such as PHASIX mesh available from Davol, GalaFLEX or GalaFLEX LITE available from Galatea, TIGR Matrix available from Novus Scientific, SERI Surgical Body available from Allergen, BIO-A available from Gore, and ULTRAPRO available from Ethicon. If desired, a non-woven material may be employed as an alternative or together with a mesh to provide a relatively softer profile for the prosthesis.

[0052] In some embodiments, the polymers used to prepare the fixation devices may have weight average molecular weights of 50 to 1,000 kDa, 90 to 600 kDa, and/or from 200 to 450 kDa relative to polystyrene determined by GPC, although other weight average molecular weight polymers are contemplated.

[0053] In some embodiments, the devices may be formed of permanent materials, such as non-biodegradable thermoplastic polymers, including polymers and copolymers of ethylene and propylene, including ultra-high molecular weight polyethylene, ultra-high molecular weight polypropylene, nylon, polyesters such as polyethylene terephthalate), polytetrafluoroethylene), polyurethanes, poly (ether- urethanes), poly(methylmethacrylate), polyether ether ketone, polyolefins, and poly(ethylene oxide). In other embodiments, devices may be formed of degradable materials, including but not limited to, thermoplastic or polymeric degradable materials. Combinations of the foregoing are contemplated. In some embodiments, the device may be formed of one or more absorbable polymers or copolymers, absorbable thermoplastic polymers and copolymers, and/or absorbable thermoplastic polyesters. The devices may be formed of polymers including, but not limited to, polymers of glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3 -hydroxy butyric acid, 4- hydroxybutyrate, e-caprolactone, including polyglycolic acid, polylactic acid, polydioxanone, polycaprolactone, copolymers of glycolic and lactic acids, such as VICRYL® polymer, MAXON® and MONOCRYL® polymers, and including poly(lactide-co-caprolactones); poly(orthoesters); poly anhydrides; poly(phosphazenes); polyhydroxyalkanoates; synthetically or biologically prepared polyesters; polycarbonates; tyrosine polycarbonates; polyamides (including synthetic and natural polyamides, polypeptides, and poly(amino acids)); polyesteramides; poly (alky lene alkylates); polyethers (such as polyethylene glycol, PEG, and polyethylene oxide, PEO); polyvinyl pyrrolidones or PVP; polyurethanes; polyetheresters; polyacetals; polycyanoacrylates; poly(oxyethylene)/poly(oxypropylene) copolymers; polyacetals, polyketals; polyphosphates; (phosphorous -containing) polymers; polyphosphoesters; polyalkylene oxalates; polyalkylene succinates; poly (maleic acids); silk (including recombinant silks and silk derivatives and analogs); chitin; chitosan; modified chitosan; biocompatible polysaccharides; hydrophilic or water soluble polymers, such as polyethylene glycol, (PEG) or polyvinyl pyrrolidone (PVP), with blocks of other biocompatible or biodegradable polymers, for example, poly(lactide), poly(lactide-co- glycolide, or polycaprolactone and copolymers thereof, including random copolymers and block copolymers thereof.

[0054] In some embodiments, a fixation device may be loaded, filled, and/or coated with an appropriate therapeutic composition. This may include coatings, absorbed materials retained in the device, adsorbed materials, compounds functionally bonded to the material of the fixation device, and/or any other appropriate way of associating a therapeutic composition with the fixation device. Appropriate types of therapeutic compositions may include, but are not limited to, cells, stem cells, differentiated cells, fat cells, muscle cells, platelets, pedicles, vascular pedicles, tissue masses, extracellular adipose matrix proteins, gels, hydrogels, hyaluronic acid, collagen, bioactive agents, drugs, antibiotics, and other appropriate therapeutic compositions that may be desirable to deliver to the implant site. The cells and tissues, which may be delivered and/or coated or injected into the device, may be autologous. The devices may be used for autologous fat transfer. The cells added, coated or injected on the device may include pancreatic islet cells, hepatic cells, and stem cells genetically altered to contain genes for treatment of patient illnesses. The devices may include bioactive agents to stimulate cell in-growth, including growth factors, cell adhesion factors, cellular differentiating factors, cellular recruiting factors, cell receptors, cell-binding factors, cell signaling molecules, such as cytokines, and molecules to promote cell migration, cell division, cell proliferation and extracellular matrix deposition. The devices may also be partially or entirely coated and/or contain agents to prevent tissue adhesion, or agents to prevent cell proliferation, particularly to delay cell invasion into the devices. [0055] In some embodiments, the fixation devices may be partially or entirely loaded, filled, coated, or otherwise incorporated with bioactive agents. Bioactive agents may be included in the devices for a variety of reasons. For example, bioactive agents may be included in order to improve tissue in-growth into the implant, to improve tissue maturation, to provide for the delivery of an active agent, to improve wettability of the implant, to reduce the risk of infection, and to improve cell attachment- The bioactive agents may also be incorporated into the material composition of the substrate of the subunits.

[0056] The devices can contain active agents designed to stimulate cell in-growth, including growth factors, cell adhesion factors including cell adhesion polypeptides, cellular differentiating factors, cellular recruiting factors, cell receptors, cell-binding factors, cell signaling molecules, such as cytokines, and molecules to promote cell migration, cell division, cell proliferation and extracellular matrix deposition. Such active agents include fibroblast growth factor (FGF), transforming growth factor (TGF), platelet derived growth factor (PDGF), epidermal growth factor (EGF), granulocyte-macrophage colony stimulation factor (GMCSF), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), hepatocyte growth factor (HGF), interleukin- 1-B (IL-1 B), interleukin-8 (IL-8), and nerve growth factor (NGF), and combinations thereof. As used herein, the term "cell adhesion polypeptides" refers to compounds having at least two amino acids per molecule that are capable of binding cells via cell surface molecules. The cell adhesion polypeptides include any of the proteins of the extracellular matrix which are known to play a role in cell adhesion, including fibronectin, vitronectin, laminin, elastin, fibrinogen, collagen types I, II, and V, as well as synthetic peptides with similar cell adhesion properties. The cell adhesion polypeptides also include peptides derived from any of the aforementioned proteins, including fragments or sequences containing the binding domains.

[0057] In some embodiments, the fixation devices may be loaded, filled, coated, or otherwise incorporated with wetting agents designed to improve the wettability of the various surfaces of the devices to allow fluids to be easily adsorbed onto the device surfaces, and to promote cell attachment and or modify the water contact angle of the device surface. Examples of wetting agents include polymers of ethylene oxide and propylene oxide, such as polyethylene oxide, polypropylene oxide, or copolymers of these, such as PLURONICS®. Other suitable wetting agents may include surfactants or emulsifiers. [0058] In some embodiments, the fixation devices may be loaded, filled, coated, or otherwise incorporated with gels, hydrogels or living hydrogel hybrids to further improve wetting properties and to promote cellular growth throughout the device. Hydrogel hybrids may consist of living cells encapsulated in a biocompatible hydrogel like gelatin, methacrylated gelatin (GelMa), silk gels, and hyaluronic acid (HA) gels.

[0059] Other bioactive agents that can be incorporated in the devices may include antimicrobial agents, in particular antibiotics, disinfectants, oncological agents, anti-scarring agents, anti-inflammatory agents, anesthetics, small molecule drugs, anti-adhesion agents, inhibitors of cell proliferation, anti- angiogenic factors and pro- angiogenic factors, immunomodulatory agents, and blood clotting agents. The bioactive agents may be proteins such as collagen and antibodies, peptides, polysaccharides such as chitosan, alginate, hyaluronic acid and derivatives thereof, nucleic acid molecules, small molecular weight compounds such as steroids, inorganic materials such as hydroxyapatite and ceramics, or complex mixtures such as platelet rich plasma. Suitable antimicrobial agents include: bacitracin, biguanide, triclosan, gentamicin, minocycline, rifampin, vancomycin, cephalosporins, copper, zinc, silver, and gold. Nucleic acid molecules may include DNA, RNA, siRNA, miRNA, antisense or aptamers.

[0060] In some embodiments, the fixation devices may be loaded, filled, coated, or otherwise incorporated with allograft material and xenograft materials, including acellular dermal matrix material and small intestinal submucosa (SIS). In some embodiments, the devices may incorporate systems for the controlled release of the therapeutic or prophylactic agents.

[0061] In some embodiments, the fixation devices may be loaded, filled, coated, or otherwise incorporated with allograft or xenograft tissue and cells prior to implantation, during implantation, or after implantation, or any combination thereof. In some embodiments, the devices may be coated with autologous tissue and cells from the patient prior to implantation, during implantation, or after implantation, or any combination thereof. The autologous tissue and cells may include one or more of the following autologous fat, fat lipoaspirate, fat tissue, injectable fat, adipose tissue, adipose cells, fibroblast cells, and stem cells, including human adipose tissue-derived stem cells, also known as preadipocytes or adipose tissue-derived precursor cells, and fibroblast-like stem cells. In one embodiment, the devices may be coated with autologous tissue and cells as described herein, and may also further include a vascular pedicle or other tissue mass.

[0062] In some embodiments, the polymers and copolymers composition of the devices may have low moisture contents to ensure the devices can be produced with stiffnesses comparable to natural tissue, prolonged strength retention, and good shelf life. In some embodiments, the polymers and copolymers that are used to prepare the devices have a moisture content of less than 1,000 ppm (0.1 wt%), less than 500 ppm (0.05 wt%), less than 300 ppm (0.03 wt%), less than 100 ppm (0.01 wt%), and/or less than 50 ppm (0.005 wt%). [0063] It should be appreciated that the compositions used to prepare the devices may have a low endotoxin content. In some embodiments, the endotoxin content may be low enough so that the devices produced from the polymer compositions have an endotoxin content of less than 20 endotoxin units per device as determined by the limulus amebocyte lysate (LAL) assay. For example, the polymeric compositions used to prepare the device may have an endotoxin content of <2.5 EU/g of polymer or copolymer. In another example, the P4HB polymer or copolymer, or PBS polymer of copolymer have an endotoxin content of <2.5 EU/g of polymer or copolymer.

[0064] In some embodiments, the devices of the present disclosure may include one or more markers for external detection of the device location. For example, a device may include a radiopaque marker (e.g., a metallic tag, radio opaque materials), which may be visible and distinct over the nearby anatomy during x-ray imaging. The markers may be formed of any suitable extended use approved medical materials that may be medically imaged. Medical imaging may be performed using, for example, radiographic imaging modalities (e.g., x-ray imaging), magnetic resonance imaging (MRI), ultrasonography, fluoroscopy, or computed tomography. The marker may therefore be formed of any nonabsorbable, biocompatible materials, which may refer to a material that does not cause any adverse reactions to a patient's health and that does not disintegrate over the lifetime of the patient. Non-absorbable, biocompatible materials may include, but are not limited to, metal containing materials, polymer materials, ceramic materials, or composite materials that include metals, polymers, or combinations of metals and polymers. Suitable metals may include, but are not limited to, gold, iridium, nickel, rhodium, silver, tantalum, titanium, stainless steel and alloys thereof, combinations thereof, and/or others. Suitable polymers include, but are not limited to, polyvinyl alcohol, polyurethanes, polyolefins, polyesters, polypropylenes, polyimides, polyetherimides, fluoropolymers, thermoplastic liquid polymers (LCP) such as, for example, Vectra® by Celanese, polyethylether ketones such as, for example, PEEK™ by Vitrex, polyamides, polycarbonates such as, for example, Makrolon® by Bayer Polymers, polysulfones, polyethersufones, polyphenyl sulfones such as, for example, Radel® by Rowland Technologies, nylon, nylon copolymers, combinations thereof, and/or others. In some embodiments, the marker may include a shape-memory material, including, but not limited to, nitinol, titanium, or any shape-memory polymers.

[0065] As noted previously, in some embodiments, soft tissue fixation devices may be used in soft tissue regeneration, augmentation, repair, reinforcement, replacement, and/or reconstruction procedures along with implants (e.g., permanent or degradable breast implants). In the case of breast procedures, the fixation devices may be used in conjunction with implants used in mastectomy, mastopexy, lumpectomy, and breast augmentation procedures. The devices may be biocompatible, and in some instances, may be absorbable such that the device may be replaced in vivo by the patient's tissue as the devices degrade. In some embodiments, the devices can be coated or filled with materials to induce tissue ingrowth and/or reduce the risk of infection. For example, the devices may be coated or filled with autologous tissue, autologous fat, fat lipoaspirate, injectable fat, adipose cells, fibroblast cells, and stem cells prior to implantation, during implantation, or post-implantation.

[0066] The fixation devices of the present disclosure may be used in any suitable application. In some embodiments, the prostheses may be used along with implants (e.g., soft or hard tissue implants) following a procedure during treatment of cancers, such as breast, abdominal, liver, muscle, kidney, lung, and prostate cancer. In some embodiments, the device may be used in soft tissue reconstruction applications, such that it may wrap around, partially enclose or fully encase a breast implant, breast lift implant, tissue expander, breast augmentation implant, nipple implant, facial reconstruction implant, buttock implant, malar augmentation device, cosmetic repair implant, soft tissue regeneration implant, hernia implant, hernia plug, wound healing implant, tissue engineering scaffold, scaffold for a vascular pedicle or other tissue mass, guided tissue repair/regeneration device, bulking or filling implant, void filler, implant for treatment of vesicoureteral reflux, cell seeded device, drug delivery device, cardiac rhythm management devices (CRM’s), pacemakers, defibrillators, pulse generators, implantable access systems, muscle and nerve stimulators, cochlear implants, ventricular assist devices, gastric stimulators, infusion pumps, drug pumps, neurostimulators, vagal nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, combinations thereof, and/or any other suitable application. In embodiments, the implant has a shape and size suitable for use in breast surgery procedures, including breast augmentation, breast reconstruction, and mastopexy. [0067] “Absorbable” as generally used herein means the material is degraded in the body, and the degradation products are eliminated or excreted from the body. The terms “absorbable”, “resorbable”, “degradable”, and “erodible”, with or without the prefix “bio”, can be used interchangeably herein, to describe materials broken down and gradually absorbed, excreted, or eliminated by the body, whether degradation is due mainly to hydrolysis or mediated by metabolic processes.

[0068] “Bioactive agent” as generally used herein refers to therapeutic, prophylactic or diagnostic agents, agents that promote healing and the regeneration of host tissue, and also therapeutic agents that reduce the risks of infection. “Agent” includes a single such agent and is also intended to include a plurality.

[0069] “Biocompatible” as generally used herein means the biological response to the material or device being appropriate for the device's intended application in vivo. Any metabolites of these materials should also be biocompatible.

[0070] “Blend” as generally used herein means a physical combination of different polymers, as opposed to a copolymer formed of two or more different monomers.

[0071] “Breast implant” as generally used herein refers to any permanent, nonpermanent (e.g., degradable), or combinations thereof implant used in breast reconstructive procedures.

[0072] “Copolymers of poly-4-hydroxybutyrate” as generally used herein means any polymer containing 4-hydroxybutyrate with one or more different hydroxy acid units. The copolymers may be isotopically enriched.

[0073] “Copolymers of poly(butylene succinate)” as generally used herein means any polymer containing 1,4-butanediol and succinic acid units, and one or more different diol or diacid units. The copolymers may include one or more of the following: branching agent, cross-linking agent, chain extender agent, and reactive blending agent. The copolymers may be isotopically enriched. [0074] “Endotoxin content” as generally used herein refers to the amount of endotoxin present in an implant or sample, and is determined by the limulus amebocyte lysate (LAL) assay.

[0075] “Poly-4-hydroxybutyrate” as generally used herein means a homopolymer containing 4-hydroxybutyrate units. It can be referred to herein as P4HB or TephaFLEX® biomaterial (manufactured by Tepha, Inc., Lexington, Mass.). The polymers may be isotopically enriched.

[0076] Tether” as used herein may refer to any generally flexible, one-dimensional structure formed from one or more yams, fibers, strings, ribbons, strands, threads, sutures, monofilaments, and/or multifilaments. Such structures may comprise knits, braids, woven materials, non-woven materials, combinations thereof, and/or any other suitable form factor. The cord materials of the present disclosure may be formed of any suitable biocompatible material or combination of materials, bioabsorbable and/or non-bioabsorbable.

[0077] Turning to the figures, specific non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described relative to these embodiments may be used either individually and/or in any desired combination as the disclosure is not limited to only the specific embodiments described herein.

[0078] FIG. 1 shows an exemplary permanent implant 10 which may be used in conjunction with the fixation devices of the present disclosure. The implant 10 may be formed of a non-absorbable material, such as silicone. In embodiments where the implant is a breast implant, the implant may be shaped in a generally hemispherical manner, with a maximum base diameter DI or similar maximum transverse dimension and an effective profile height Hl, as shown in FIG. 1. The base diameter may be any suitable size depending on the natural anatomy of the patient and the desired resultant shape of the implant. For example, the maximum base diameter DI may include, but is not limited to, greater than or equal to approximately 6 cm, 8 cm, 10 cm, 12 cm, 15 cm, 18 cm, 20 cm, 22 cm, and/or less than or equal to approximately 22 cm, 20 cm, 18 cm, 15 cm, 12 cm, 10 cm, 8 cm, 6 cm, and/or any other suitable maximum diameter. Combinations of the foregoing ranges, including maximum base diameters between approximately 6 cm and 22 cm, between 8 cm and 18 cm, and/or ranges greater than and less than the aforementioned ranges are contemplated. Similarly, the profile height of the implant may be any suitable diameter to accommodate the patient anatomy and desired implant shape. Exemplary profile heights Hl include, but are not limited to, between 2 cm and 15 cm, 3 cm and 10 cm, 4 cm and 7 cm, combinations thereof, and/or any other suitable size.

[0079] In some embodiments, the size of the implant may be determined volumetrically. Accordingly, the fixation devices of the present disclosure may be compatible with any suitable conventional implant size, including, but not limited to, greater than, less than, or equal to, 50 cc, 60 cc, 70 cc, 80 cc, 90 cc, 100 cc, 110 cc, 120 cc, 130 cc, 140 cc, 150 cc, 160 cc, 170 cc, 180 cc, 190 cc, 200 cc, 210 cc, 220 cc, 230 cc, 240 cc, 250 cc, 260 cc, 270 cc, 280 cc, 290 cc, 300 cc, 310 cc, 320 cc, 330 cc, 340 cc, 350 cc, 360 cc, 370 cc, 380 cc, 390 cc, 400 cc, 410 cc, 420 cc, 430 cc, 440 cc, 450 cc, 460 cc, 470 cc, 480 cc, 490 cc, 500 cc, 510 cc, 520 cc, 530 cc, 540 cc, 550 cc, 560 cc, 570 cc, 580 cc, 590 cc, 600 cc, 610 cc, 620 cc, 630 cc, 640 cc, 650 cc, 660 cc, 670 cc, 680 cc, 690 cc, 700 cc, 710 cc, 720 cc, 730 cc, 740 cc, 750 cc, 760 cc, 770 cc, 780 cc, 790 cc, 800 cc, and/or any other suitable implant size.

[0080] FIG. 2 shows a fixation device 100 in an expanded two-dimensional configuration, according to some embodiments. The device 100 may include a peripheral portion, where one or more legs 110 extending radially away from a central portion 111. In some instances a plurality of legs extending outward from the central portion may be distributed around a perimeter of the central portion. As will be described in greater detail below, the legs 110 may be sized to enclose a portion of the implant (e.g., a breast implant) to help secure the implant to the patient anatomy. The central portion 111 may be sized to cover a portion of the implant (e.g., a portion of the curved face of a breast implant).

[0081] In some embodiments, the central portion 111 may have a maximum diameter D2, or other appropriate maximum transverse dimension, which may be less than a maximum diameter of the implant DI, as shown in FIG. 2. This difference in diameter forms spacing 112 between the legs 110, which may allow the legs to be wrapped around an implant with minimal risk of wrinkling or warpage. In some embodiments, the presence of spacing 112 between the legs 110 may also enable the device 100 to be wrapped around a variety of implants having different sizes. Accordingly, the ratio between the central portion maximum diameter D2 and the implant diameter DI may be any suitable ratio, less than or equal to 1. In some embodiments, a central portion of the implant fixation device may be approximately aligned with a central portion of an adjacent surface of the implant. [0082] As shown in FIG. 2, the peripheral legs 110 may extend radially away from the central portion 111. It should be appreciated that although six legs are shown, each extending an equal distance away from the central portion, embodiments where the legs are asymmetrically distributed around the central portion are also contemplated, as well as embodiments having more than or less than six legs. For example, an implant fixation device includes 3 legs. When in an expanded flat configuration, the legs may be circumscribed by an imaginary circle with a diameter D3 which may be referred to as a diameter or maximum transverse dimension of the device, as shown in FIG. In some embodiments, the diameter D3 may be sufficiently large to allow for one or more legs 110 to extend from a first surface (e.g., a rounded face of a breast implant) to a second surface (e.g., a flat face of a breast implant) to partially or entirely wrap around or encase the implant. Accordingly, the maximum diameter D3 of the device may be greater than a maximum diameter DI of the implant, as shown in FIG. 2. The diameter D3 may also be sufficiently small to reduce the risk of significant material overlap during wrapping of the implant.

[0083] In some embodiments, the maximum diameter D3 of the device may be selected in accordance with the implant diameter, which may differ depending on patient needs, as previously described. The device maximum diameter D3 may be any suitable size to accommodate the implant diameter, including, but not limited to, greater than or equal to approximately 110%, 120%, 130%, 150%, 180%, 200%, 220%, 250%, 280%, 300%, combinations thereof, and/or less than or equal to approximately 300%, 280%, 250%, 220%, 200%, 180%, 150%, 130%, 120%, 110%, combinations thereof, and/or any other percentage of the implant diameter DI .

[0084] In some embodiments, each leg 110 may include at least one tab 115 positioned between the central portion 111 and a distal end portion of a leg the at least one tab is disposed on, as shown in FIG. 2. In some embodiments a plurality of tabs may be associated with the plurality of legs. For example, each leg may include one or more tabs attached to the associated leg using any appropriate attachment and/or integral formation with the legs. The tabs 115 may allow the device to be secured to a patient’s anatomy to help maintain the device in place relative to the anatomy. In the case of a breast reconstruction procedure, the device may be secured to the patient’s pectoralis wall.

[0085] In the expanded configuration of the device 100, each tab may be arranged within, or parallel to, the two-dimensional plane of a respective leg. The tabs 115 may be coupled to legs in a manner that allows each tab to be deformed in a direction that is oriented out of the plane of the leg. For example, as shown in FIG. 2, the tabs may be formed along the body of the leg using cuts to form a tab including a distal portion relative to the central portion of the device in the expanded configuration that is attached to the leg. In some embodiments, the tabs may be separately formed from the legs (e.g., a separate prosthetic mesh material) which may be attached to the legs at a distal portion of the tabs. As will be described in greater detail below, the tabs may move between a first orientation oriented toward the central portion 111 in the expanded configuration to a second orientation oriented away from the central portion when the device is wrapped around an implant.

[0086] As noted above, in some embodiments, the tabs 115 may be formed directly along the legs 110. For example, the tabs 115 may be cut from the legs through any suitable technique, including, but not limited to, trimming or cutting with scissors, blades, other sharp cutting instruments, or thermal knives, laser-cutting techniques, die-cutting techniques, water jets, hand-cutting, combinations thereof, and/or any other suitable technique. In other embodiments, the tabs may be formed separately and connected to the legs through any suitable method including, but not limited to thermal sealing, welding (e.g., ultrasonic or otherwise), adhesive bonding, sutures, combinations thereof, and/or any other suitable technique.

[0087] It should be appreciated that regardless of the formation type of the tabs, the tabs may be arranged to have a proximal portion of the tab oriented towards the central portion of the device in the expanded configuration which may be freely movable, and may therefore be reoriented when the device is wrapped around an implant. As shown in FIG. 2, the tabs may be pointed towards the central portion in their first orientation when the device is in the expanded configuration. As will be described in greater detail below, when the device is positioned around the implant in the wrapped configuration, the tabs may extend outward from the device, pointing away from the central portion. A surgeon may then use these outwardly pointing tabs to secure the device to the patient anatomy.

[0088] It should be appreciated that that the tabs may be arranged at any location along their respective leg. In some embodiments, as shown in FIG. 2, the tabs may be arranged approximately in the middle of a leg extending between the central portion 111 of the device and a distal end of the leg. In other embodiments, the tabs may be arranged closer to the distal end portion of a leg than the central portion. In other embodiments still, the tabs may be arranged closer to the central portion than the distal end portion of the leg. It should be appreciated that the position of the tab relative to the leg may facilitate the wrapping of one or more implant sizes. Accordingly, the present disclosure is not limited by the arrangement of the tabs on the legs.

[0089] The tabs may have any suitable size relative to their respective leg. In embodiments where the tabs are formed from the leg body, the tabs may have a width less than the width of the leg body. In embodiments where the tabs are formed of material coupled to the leg body, the tab width may be equal to approximately the width of the legs, and/or may be smaller than the width of the leg width. It should be appreciated that the present disclosure is not limited by the shape or size of the tabs.

[0090] FIG. 2 shows each leg 110 having a tab 115. In some embodiments, the device may include one or more legs having tabs and one or more legs having no tabs. The tab arrangement may be dependent upon how the surgeon plans to secure the device on the patient anatomy. Accordingly, the device may include any suitable number of tabs, equal to and/or less than the number of legs. Additionally, instances in which multiple tabs are included on a single leg are also contemplated.

[0091] It should be appreciated that although six symmetric legs are shown in FIG. 2, embodiments having more than six legs and embodiments having less than six legs are contemplated. In some embodiments, the legs may not be symmetrically distributed around the central portion. For example, a device may have more legs on the portion of the device corresponding to the lower pole of a breast implant to provide more structural support in response to gravitational forces. It should also be appreciated that although the legs of FIG. 2 are shown to be substantially similar in size and shape, embodiments having differently sized/shaped legs are contemplated, as the present disclosure is not limited by the number of, size, shape, and/or arrangement of the legs relative to the central portion.

[0092] In some embodiments, the device 100 may include a tether 120 coupled to the distal ends of one or more legs 110, as shown in FIG. 2. The tether 120 may allow a surgeon to transition the device from its expanded configuration to its wrapped configuration without having to manually fold or arrange each leg around the implant. The tether may function as a drawstring, allowing the surgeon to rapidly wrap the device around the implant by applying tension to the tether 120. In some embodiments, the tether may include handling portions 125, which allow the tether to be tensioned and the device to be wrapped around the patient. The tether 120 may be coupled to the legs 110 in one or more areas 122. The coupling may allow the tether to be axially moveable relative to the leg to allow the tether to be tensioned but may not be fixed to the legs. For example, the tether may be threaded through one or more pores of the porous material of the legs 110. As shown in FIG. 2, in some embodiments, at least one end of the tether 120 may include a needle 128 to facilitate the weaving or coupling of the tether 120 to the legs. Alternatively, other methods of slidably attaching the tethers to the legs may be used as the disclosure is not limited in this fashion.

[0093] It should be appreciated that the tether may be formed of a flexible material to be able to weave through or otherwise couple to the legs, but may be sufficiently inelastic, reducing the likelihood of excessive axial extension preventing proper wrapping of the device. In some embodiments, the tether 120 may be formed of a polypropylene suture.

[0094] Although the tether 120 is shown to be woven through a distal portion of the legs 110, it should be appreciated that the tether may be coupled to any portion or combination of portions of any of the legs of the present disclosure to enable wrapping of the implant upon tensioning of the tether.

[0095] FIG. 3 shows three sizes of fixation devices formed of a porous biocompatible material along with exemplary permanent implants. Fixation device 100A represents a small device to accommodate small permanent implants 10 A, fixation device 100B represents a medium device to accommodate medium permanent implants 10B, and fixation device 100C represents a large device to accommodate large permanent implants 10C. As shown in FIG.

3, in some embodiments, the device may include tabs 115C arranged along legs of the device to facilitate securement of the device to the patient anatomy. Implants may be characterized to be “small” if they have a maximum base diameter of approximately 9 to 12 cm and a profile height of approximately 3.5 to 5 cm, “medium” if they have a maximum base diameter of approximately 11 to 14 cm and a profile height of approximately 4.5 to 6 cm, “large” if they have a maximum base diameter of approximately 12 to 15.5 cm and a profile height of approximately 5 to 7 cm, and “extra-large” if they have a maximum base diameter of approximately 13 to 17 cm and a profile height of approximately 3 to 7 cm. It should be appreciated that the categorization of implant sizes is exemplary and that the fixation devices described herein may be employed with any size breast implant.

[0096] Fixation device 100C of FIG. 3 is shown in the expanded configuration, with each leg radiating away from the central portion (obscured by the implant 10C). As shown, the tabs 115C are oriented such that the proximal portions of the tabs, relative to a distal end portion of the associated leg, point toward the central portion when the device 100C is in the expanded configuration.

[0097] FIG. 4 shows a backside view of an implant fixation device 100 in a wrapped configuration, folded over an implant 10. To reach this configuration, the legs 110 of the device 100 may be brought together on the opposing side of the implant through a tensioning of the tether 120, as previously described. The tensioning of the tether on the opposing face of the implant may serve as a drawstring to bring together the legs and wrap the device around the implant. In some embodiments, the tether 120 may be used to suture the distal ends of the legs together prior to delivery. In some embodiments, the tether 120 may be knotted to maintain the tensioned configuration of the tether and the wrapped configuration of the legs. Due to the change in configuration and arrangement of the legs 110 of the device, a free end of the tabs 115 may now be oriented such that the tabs point away from the central portion (obscured by implant 10 in FIG. 4). A surgeon may secure the implant and device assembly to the patient anatomy through the one or more tabs 115 following delivery.

[0098] It should be appreciated that in some embodiments, the implant 10 may be delivered to the implant site (e.g., within the chest cavity) at least partially wrapped in the device 100. In this way, the device may protect or otherwise shield the implant from contact with the incision site and/or excessive contact by the surgeon to minimize risks of undesirable contamination.

[0099] FIG. 5 shows a front side view of an implant 10 wrapped with an implant fixation device 100 and installed on a patient chest wall or pectoralis muscle 20. As shown, the central portion 111 of the device 100 may cover a portion of the breast implant 10 to facilitate tissue ingrowth around the implant. The legs 110 may be wrapped around to the other side of the implant, causing the tabs 115 to shift into an orientation pointing away from the central portion. Therefore, the tabs may extend outwardly from the device when installed on the patient anatomy. In this way, the tabs 115 may allow a surgeon to secure the device 100 to the patient anatomy. In some embodiments, the tabs 115 may be sutured 119 to the chest 20, as shown in FIG. 5. In other embodiments, other fasteners, including, but not limited to, staples, tacks, barbs, hooks, adhesives, combinations thereof, may be employed. In some embodiments, as shown in FIG. 5, each tab 115 may be secured to the anatomy 20, whereas in other embodiments, a subset of the tabs may be secured to the anatomy. The surgeon may elect to secure the device to the anatomy through any one or more of the tabs of the device.

[00100] FIG. 5 shows a fixation device 100 having tabs 115 formed within the body of the legs 110. Accordingly, when the device is in the wrapped configuration, as shown in FIG. 5, the tabs 115 may extend out of the plane of the legs and leave behind an opening 118. These openings may not be present in embodiments where the tabs are formed separately and attached or otherwise coupled to the device.

[00101] As described previously, the legs 110 may form spacings 112 in between adjacent legs to allow the device 100 to conform to the curvature of the implant 10, reducing the risk of wrinkling and undesirable textural deformities on the implant. The spacings 112 may also allow the device to wrap a number of implant sizes without having to repeatedly customize the shape and size of the fixation device to the implant. This process may expedite the surgical procedure, which may improve outcomes.

[00102] FIG. 6 shows an exemplary fixation device 100 wrapped around an implant 10. The fixation device includes six tabs 115, extending away from the central portion of the device in the wrapped configuration to allow a surgeon to secure the implant and device assembly to the patient anatomy. As shown, the tabs 115 may be formed along the device legs, leaving behind openings 118 when arranged in the wrapped configuration.

[00103] FIG. 7 shows two separate fixation devices 100 of the same design wrapped around two separate implants 10D, 10E of differing profile heights. As shown, the spacings between the fixation device legs enable the device to accommodate implants of differing sizes (e.g., profile height or base diameter, in the case of breast implants) without having to modify the shape of the device. In this way, the fixation device may be standardized to accommodate various implants within a desired size range. As described previously, in some embodiments, the device may be formed in a variety of standard sizes (e.g., small, medium, large, extra-large) to accommodate a broad range of breast implants. In some embodiments, the variety of fixation devices may cover 90% of conventional breast implant sizes.

[00104] FIG. 8 shows another embodiment of an implant fixation device 200. The fixation device 200 may include a central portion 211 to accommodate a breast (and/or other soft tissue) implant. The central portion 211 may be pre-formed with curvature such that the central portion is sized and shaped to at least partially conform to a front facing surface of a breast implant. In some embodiments, the device 200 of FIG. 8 may provide more spatial coverage to the breast implant in comparison to the device 100 of FIGs. 2-7. The curvature of the central portion 211 may reduce the likelihood of wrinkling or other surface deformities due to its conformal contact with the underlying breast implant.

[00105] In some embodiments, the central portion 211 may be thermoformed and/or compression molded to form and maintain a generally three-dimensional shape prior to wrapping around a breast implant. Therefore, the expanded configuration of the device 200 may not be substantially two-dimensional in the expanded configuration, as was the case for the device 100 of FIGs. 2-7. Any suitable conventional forming technique may be employed. For example, the device 200 may be formed of a thermoplastic two-dimensional porous repair fabric, which may be arranged in a mold having the curvature of a breast implant, the mold may be exposed to thermal or compressive forces to help retain the shape of the mold. In some embodiments, the device may be quenched or otherwise treated to enhance a particular property of the material. It should be appreciated that any suitable molding or forming technique may be employed to create the curvature of the central portion, as the present disclosure is not limited by the techniques of formation.

[00106] As shown in FIG. 8, the implant fixation device 200 may include a peripheral rim 213 extending outwards from and at least partially, and in some instances completely, around a perimeter of the central portion 211. During an exemplary procedure, a breast implant may be positioned inside the central portion 211, aligning any potential curvature of the implant with the device, and the peripheral rim 213 may be wrapped around the back side of the implant. The rim 213 may function similarly to the legs of the device 100 of FIGs. 2-7, in that it may serve to retain the implant within the fixation device. The peripheral rim 213 may be arranged to be wrapped around the implant, forming a shell or coverage for the implant.

[00107] In some embodiments, the central portion 211 may have a maximum diameter D4 which may accommodate the implant. Accordingly, the maximum diameter D4 of the device 200 may be approximately equal to, or slightly less than, the maximum diameter DI of the implant, as shown in FIG. 1. It should be appreciated that the central portion 211 may include at least some elasticity and may be able to marginally expand due to applied forces, such that the maximum diameter D4 of the central portion 211 may be less than or equal to the implant diameter DI. Similarly, the device 200 may have a profile height Hl that is substantially equal to, or slightly less than, the profile height Hl of the implant, as shown in FIG. 1. Of course, embodiments with the device profile height being slightly greater than the implant profile height are also contemplated.

[00108] The peripheral rim 213 of device 200 may have a maximum diameter D5 which may correspond to the maximum diameter D3 of the device shown in FIG. 2. In some embodiments, the average rim diameter D5 may be greater than the maximum diameter D4 of the central portion 211 to allow the peripheral rim 213 to wrap around the implant. In some embodiments, the peripheral rim 213 may be long enough to extend at least halfway across the base diameter. Accordingly, the peripheral rim diameter D5 may be approximately equal to twice the central portion diameter D4. The peripheral rim diameter D5 may be any suitable proportion of the central portion diameter D4, including, but not limited to, greater than or equal to approximately 125%, 150%, 180%, 200%, 250%, 300%, and/or less than or equal to approximately 300%, 250%, 200%, 180%, 150%, 125%, combinations thereof, and/or any other proportion of the central portion diameter D4.

[00109] It should be appreciated that an implantation device may have any suitable size and geometry (e.g., central portion diameter, profile height, etc.) to accommodate a desired implant size, as the present disclosure is not so limited. It should also be appreciated that although the peripheral rim is shown to be radially symmetric around the central portion 211, embodiments where the rim is asymmetric around the central portion are also contemplated.

[00110] FIG. 9 shows a device 200 according to some embodiments. The device 200 may be formed of a porous biocompatible material, and may include a central portion 211 having a generally rounded shape to accommodate curvature of an implant (e.g., a permanent breast implant), and a peripheral rim 213. FIG. 9 shows the device 200 is its expanded configuration, prior to assembly with an implant. As shown in the figure, the device may be in a generally three-dimensional configuration prior to assembly.

[00111] FIG. 10 shows a device 200 similar to that shown in Fig. 9 assembled with a silicone breast implant. The peripheral rim 213 of the device may be wrapped around the implant to provide an external covering of the implant. In some embodiments, a tether 120 may be employed to help rearrange the peripheral rim 213 from the expanded configuration (shown in FIG. 9) to the wrapped configuration of FIG. 10. The tether 120 may include handling portions 125 to allow a surgeon to apply tension to the tether and wrap the implant in the fixation device without having to manually manipulate the rim. As described previously, the tether may be woven through or otherwise coupled to an outer portion of the peripheral rim of the fixation device to facilitate the drawstring effect.

[00112] FIGs. 11 A-l ID show a fixation device 300 according to some embodiments. The device 300 may include a curved central portion 311 and one or more legs 310 extending from the central portion. The central portion 311 may have a generally hemispherical shape to correspond to the curved surface of a breast implant. In some embodiments, the central portion 311 may be provided in the pre-formed shape. The central portion may be pre-formed using any suitable technique, such as the techniques described relative to device 200 of FIG. 8. FIGs. 11 A-l IB show the device 300 partially installed on an implant 10. As shown, the central portion 311 of the device 300 may conform to the curvature of an implant 10 to reduce the likelihood of wrinkles or other undesirable structural deformities.

[00113] In some embodiments, a maximum diameter of the central portion 311 of the device 300 may be smaller than the maximum diameter of the implant 10, such that the legs 310 may extend partially on the curved anterior surface of the breast implant, as shown in FIG. 11 A. Accordingly, a portion of the legs 310 may also be pre-formed in a curved shape, as shown. As described previously, spacing 312 between the legs may enable the device 300 to accommodate a variety of different implant types.

[00114] In some embodiments, the device may be adjusted to improve the conformal fit of the central portion. For example, the device may include one or more holes 319 extending from an outer surface of the device oriented away from the implant to an inner surface oriented toward the implant when the implant is disposed therein. A suture may be threaded through the holes and subsequently tensioned to tighten or otherwise adjust the central portion against the implant. In some embodiments, the holes 319 may be macro pores specifically designed to facilitate adjustment of the central portion, or in some embodiments, the holes 319 may represent one or more pores of the repair fabric from which the device is formed. Similarly, the device may include one or more pores 317 on the legs 310, through which a suture may be threaded to facilitate the re-configuration of the device from its expanded configuration shown in FIGs. 11 A-l IB to its wrapped configuration shown in FIGs. 11C-1 ID. It should be appreciated that the holes 319 may be macro pores arranged in the legs, or may, in some embodiments, be a subset of the pores of the porous substrate from which the device is formed. As described earlier relative to devices 100, 200, the fixation device 300 may be reconfigured to the wrapped configuration shown in FIGs. 11C-1 ID to help cover the implant and provide a biocompatible scaffold for tissue ingrowth.

[00115] FIG. 12 shows an exemplary fixation device 300 formed of a biocompatible porous substrate. The device 300 may include a curved central portion 311 and one or more legs 310 extending outward from the central portion. FIG. 12 shows the device 300 in its expanded configuration, prior to installation on an implant. In this expanded configuration, the device may be three-dimensional due to the curvature of the central portion 311. As described earlier relative to fixation device 100, the device 300 may have any suitable number of legs 310 in any suitable arrangement (e.g., symmetric or asymmetric) around the central portion to help distribute the load of the implant. A tether (not shown) may be used to rapidly wrap the legs 310 of the device 300 around an implant to provide a biocompatible scaffold for tissue ingrowth.

[00116] FIGs. 13A-13D show a process of wrapping an implant fixation device 400 around an implant 10, according to some embodiments. The device 400 may include a central portion 411 configured to wrap around the curved, front-portion of the permanent implant 10, as well as a series of radiating legs 410 arranged around the central portion 411. The legs 410 may be arranged to span around the implant 10 to the back, flatter portion of the implant. In some embodiments, as shown in FIG. 13 A, the legs 410 may include a series of sets, each including a pair of legs 410A, 410B. Thus, the device 400 may include a central diameter D6 measured radially around the root portion of each pair of legs, as well as an intermediate diameter D7, measured radially around a point where each leg 410A, 410B branches away from its pair. It should be appreciated that any suitable proportion between the central D6 and intermediate diameter D7 may be employed, as the present disclosure is not limited by the geometry of the legs 410. In some embodiments, the fixation device may include a tether 120, which may be pre-threaded through the legs 410, as shown in FIG. 13B. The tether 120 may have a free distal end which may be tensioned to help wrap the legs 410 around the implant 10.

[00117] In some embodiments, a process of wrapping the fixation device 400 around an implant may involve first laying the device 400 in an expanded configuration, as shown in FIG. 13 A. The implant 10 may then be placed on a central portion 411 of the device 400, as shown in FIG. 13B. A clinician may then apply tension to a tether 120 threaded through one or more legs 410 of the device 400 to help transition the device to a wrapped configuration, as shown in FIGs. 13C-13D. As shown in FIG. 13C, a portion of the legs 410 may be arranged around the curved surface of the implant 10, while the remaining portion of the legs 410 may be positioned on the backside of the implant, as shown in FIG. 13D. In some embodiments, the tether 120 may be knotted or otherwise secured to reduce the risk of the tether unraveling and reversing the fixation device back to the expanded configuration.

[00118] The implant fixation device 400 of FIGs. 13A-13D may accommodate any size of implant 10, including any of the aforementioned ranges of implant sizes. For example, the fixation device can be used with a 250 cc or 350 cc implant.

[00119] FIG. 14 shows an exploded view of an implant fixation device 500 according to some embodiments. The device 500 may be formed of three components, including a central portion 501, configured to be wrapped around the central, curved portion of the fixation device, and two backside portions 502, 503, configured to be wrapped around the flatter, backside portion of the implant. In some embodiments, the central portion 501 may be formed in a generally circular fashion, as shown in FIG. 14, although other non-circular geometries are also contemplated. The backside portions 502, 503 may be formed as partial circles. In some embodiments, the backside portions may be larger than semicircles, such that the backside portions may overlap over one another when the device 500 is assembled.

[00120] FIGs. 15A-15B show the device 500 of FIG. 14 assembled with a suture or thread 120. The suture 120 may span around a periphery of the central portion, and the backside portions, creating a pocket therein. An implant may be inserted into the device through an opening between the overlapping backside portions. FIG. 15A shows a bottom-up view of the assembled device 500, showing the overlapping backside portions 502, 503. FIG. 15B shows a top-down view of the device 500, where the central portion 501 spans the entirety of the front side of the device 500.

[00121] FIGs. 16A-16C show the implant fixation device 500 of FIGs. 14-15B wrapped around an implant 10, which may be partially visible from the top-down view of FIG. 16 A. As described previously, the implant may be inserted into a pocket between the central portion 501 and the backside portions 502, 503 through a slot formed between the two backside portions, which may be seen in the bottom -up view of FIG. 16B. FIG. 16C shows a perspective view of the implant 10 installed in the device 500, as well as the suture 120 extending around the perimeter of the device 500. [00122] It should be appreciated that although the device 500 of FIGs. 14-16C is shown to be formed of three sheets of material, embodiments formed of less than or greater than 3 sheets are also contemplated. For example, a single pre-formed sheet of porous absorbable material may be used to wrap around the front and backside of the implant.

[00123] While some figures related to embodiments of three dimensional preformed implant fixation devices do not include securement tabs, it should be appreciated that the tabs described relative to FIG. 2 may be employed with any of the fixation devices described herein including on the legs and peripheral rim of the above described three dimensional preformed implants. However, in some embodiments, the fixation device may not include securement tabs, and a portion of the device may be directly secured to the patient anatomy. [00124] The foregoing description of various embodiments are intended merely to be illustrative thereof and that other embodiments, modifications, and equivalents are within the scope of the disclosure.

[00125] For purposes of this patent application and any patent issuing thereon, the indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and/or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified. [00126] The use of “including,” “comprising,” “having,” “containing,” “involving,” and/or variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[00127] The embodiments described herein may be embodied as a method, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[00128] While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments or examples. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those of skill in the art. Accordingly, the foregoing description and drawings are by way of example only.

[00129] While several embodiments of the present invention have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present invention. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the invention may be practiced otherwise than as specifically described and claimed. The present invention is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present invention.

Claims

1. An implant fixation device to secure an implant in a patient, the device comprising: a central portion sized and shaped to at least partially cover a first surface of the implant; and a peripheral portion extending radially away from the central portion; wherein the peripheral portion comprises at least one tab that extends radially toward the central portion in a first orientation when the implant fixation device is in a first expanded configuration, and wherein the device is formed of a porous biocompatible material.

2. The implant fixation device of claim 1, wherein the at least one tab extends radially outward from the central portion in a second orientation when the implant fixation device is in a second wrapped configuration .

3. The implant fixation device of claim 1, wherein the peripheral portion comprises a plurality of legs.

4. The implant fixation device of claim 3, wherein the at least one tab comprises a plurality of tabs.

5. The implant fixation device of claim 4, wherein each tab of the plurality of tabs is disposed on a separate leg of the plurality of legs.

6. The implant fixation device of claim 1, wherein the central portion is substantially two-dimensional when the device is in the first expanded configuration.

7. The implant fixation device of claim 1, wherein the central portion is pre-formed in a substantially three-dimensional shape configured to receive the implant therein.

8. The implant fixation device of claim 1, wherein a maximum transverse dimension of the central portion is smaller than a maximum base diameter of the implant.

9. The implant fixation device of claim 1, further comprising a tether coupled to the peripheral portion, the tether configured to be tensioned to draw the peripheral portion radially inwards to at least partially enclose the implant between the central portion and the peripheral portion when the implant fixation device is in a second wrapped configuration.

10. The implant fixation device of claim 1, wherein the device is formed of poly-4- hydroxybutyrate.

11. The implant fixation device of claim 1, wherein the implant is a breast implant, and wherein the first surface is an anterior surface of the implant.

12. A method of operating an implant fixation device, the method comprising: positioning a central portion of the device to at least partially cover a first surface of the implant; wrapping a peripheral portion of the device to at least partially cover a second surface of the implant, the peripheral portion extending radially away from the central portion; moving one or more tabs attached to the peripheral portion from a first orientation oriented towards the central portion to a second orientation oriented away from the central portion; and securing the one or more tabs to an implant site.

13. The method of claim 12, wherein wrapping the peripheral portion of the device comprises applying tension to a tether coupled to the peripheral portion to draw the peripheral portion radially inwards to at least partially enclose the implant between the central portion and the peripheral portion when the implant fixation device is in a second wrapped configuration.

14. The method of claim 12, further comprising implanting an assembly of the implant fixation device and the implant into a chest cavity through an incision site prior to securing the one or more tabs to the implant site.

15. The method of claim 12, wherein the peripheral portion comprises a plurality of legs, wherein each of the one or more tabs is disposed on a leg of the plurality of legs.

16. The method of claim 12, wherein the device is formed of poly-4-hydroxybutyrate.

17. An implant fixation device to secure an implant in a patient, the device comprising: a central portion sized and shaped to at least partially cover a first surface of the implant; a peripheral portion extending radially away from the central portion when the implant fixation device is in a first expanded configuration; and a tether coupled to the peripheral portion, the tether configured to be tensioned to draw the peripheral portion radially inwards to at least partially enclose the implant between the central portion and the peripheral portion when the implant fixation device is in a second wrapped configuration, wherein the device is formed of a porous biocompatible material.

18. The implant fixation device of claim 17, wherein the tether is woven through pores of the peripheral portion.

19. The implant fixation device of claim 17, wherein the tether is formed of a substantially inelastic material.

20. The implant fixation device of claim 17, further comprising at least one tab that extends radially toward the central portion in a first orientation when the implant fixation device is in the first expanded configuration.

21. The implant fixation device of claim 20, wherein the peripheral portion comprises a plurality of legs, wherein the at least one tab comprises a plurality of tabs, and wherein each tab of the plurality of tabs is disposed on a separate leg of the plurality of legs.

22. The implant fixation device of claim 17, wherein the central portion is substantially two-dimensional when the device is in the first expanded configuration.

23. The implant fixation device of claim 17, wherein a maximum transverse dimension of the central portion is smaller than a maximum base diameter of the implant.

24. The implant fixation device of claim 17, wherein the central portion is pre-formed in a substantially three-dimensional shape configured to receive the implant therein.

25. The implant fixation device of claim 17, wherein the device is formed of poly-4- hydroxybutyrate.

26. The implant fixation device of claim 17 wherein the implant is a breast implant, and wherein the first surface is an anterior surface of the implant.

27. A method of operating an implant fixation device, the method comprising: positioning a central portion of the device to at least partially cover a first surface of the implant; and applying tension to a tether coupled to a peripheral portion of the device to draw the peripheral portion radially inwards to at least partially enclose the implant between the central portion and the peripheral portion when the implant fixation device is in a second wrapped configuration.

28. The method of claim 27, further comprising weaving the tether through the peripheral portion of the device.

29. The method of claim 27, further comprising moving one or more tabs attached to the peripheral portion from a first orientation oriented towards the central portion to a second orientation oriented away from the central portion, and securing the one or more tabs to an implant site.

30. The method of claim 29, further comprising implanting an assembly of the implant fixation device and the implant into a chest cavity through an incision site prior to securing the one or more tabs to the implant site.