Implant fixation devices and related methods

Abstract

The present invention provides an implant fixation device and related methods. [Solution] The fixation device can be wrapped around the implant before delivery to reduce the risk of implant migration after implantation. The device can be porous to induce internal tissue growth around the implant and improve the outcome of the procedure. The device can be prepared quickly and adapted to various implant sizes.

Description

Technical Field

[0001] Cross - reference to Related Applications

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 63 / 503,453, filed on May 19, 2023, the content of which is hereby incorporated by reference in its entirety.

[0002] Field

[0002] This disclosure generally relates to the field of surgery, and more specifically, to an implantable medical device that restricts the movement of breast implants after breast - related procedures, including breast reconstruction such as augmentation mammaplasty, breast lift, and breast revision surgery.

Background Art

[0003] Background

[0003] Breast reconstruction after mastectomy is a surgical procedure that provides both aesthetic and psychosocial benefits to patients and is an essential and important part of breast cancer treatment. In the United States, currently, approximately 65% of breast reconstruction surgeries use tissue expanders to create a pocket for a permanent breast implant in the first stage of the procedure. Some patients can form a pocket for a breast implant without using a tissue expander. Once the pocket is created, the tissue expander is removed and replaced with a permanent breast implant in the second stage.

[0004]

[0004] Breast implants can also be used to increase the size of the breast in augmentation mammaplasty and breast lift procedures. In the latter procedure, a breast lift is combined with an augmentation. Most commonly, breast implants are placed in a pocket under the breast tissue, but in some cases, they are implanted under the chest wall. In some cases, breast implants are used in breast revision surgery to replace an existing implant with a new one. Revision surgery may be performed if the existing implant was not properly positioned during the initial placement procedure and / or if some long - term complication occurred after implantation.

[0005]

[0005] Breast implants differ in dimensions, shape, and surface texture. A wide variety of different dimensions are available, allowing surgeons and patients to choose from a wide range of protrusion, height, width, and overall volume. In terms of shape, there are round and anatomically shaped implants, and the surface of the implant may be smooth, micro-textured, or macro-textured. Generally, round implants have a smooth surface, while anatomically shaped implants have a recessed micro- or macro-textured surface. [Overview of the Initiative] [Means for solving the problem]

[0006] overview

[0006] In some embodiments, implant fixation devices are disclosed. An implant fixation device for fixing an implant in a patient's body may include a central portion having a size and shape such that it at least partially covers a first surface of the implant, and a peripheral portion extending radially outward from the central portion, the peripheral portion including at least one tab extending radially toward the central portion in a first orientation when the implant fixation device is in a first deployed form, and the device is formed of a porous biocompatible material.

[0007]

[0007] In another embodiment, an implant fixation device is disclosed. An implant fixation device for fixing an implant in the body of a patient may include a central portion having a size and shape such that it at least partially covers a first surface of the implant, a peripheral portion extending radially outward from the central portion when the implant fixation device is in a first deployed configuration, and a tether connected to the peripheral portion, the tether being tensed to pull the peripheral portion radially inward so that when the implant fixation device is in a second wrapped configuration, the implant is at least partially enclosed between the central portion and the peripheral portion, and the device is formed of a porous biocompatible material.

[0008]

[0008] In yet another embodiment, a method for operating an implant fixation device is disclosed. The method for operating an implant fixation device includes positioning the central portion of the device so as to partially cover a first surface of the implant, wrapping the peripheral portion of the device so as to partially cover a second surface of the implant, wherein the peripheral portion extends radially outward from the central portion, moving one or more tabs attached to the peripheral portion from a first orientation toward the central portion to a second orientation toward outward from the central portion, and fixing one or more tabs to the implant site.

[0009]

[0009] In yet another embodiment, a method for operating an implant fixation device is disclosed. The method for operating an implant fixation device includes positioning the central portion of the device so as to at least partially cover the first surface of the implant, and applying tension to a tether attached to the peripheral portion of the device so as to pull the peripheral portion radially inward so as to at least partially encapsulate the implant between the central portion and the peripheral portion when the implant fixation device is in a second wrap configuration.

[0010]

[0010] Since the disclosure is not limited in this respect, it should be understood that the concepts described above and any additional concepts discussed later may be arranged in any preferred combination. Furthermore, other advantages and novel features of the disclosure will become apparent from the following detailed description of various non-limiting embodiments, when considered in conjunction with the accompanying figures.

[0011] Brief explanation of the drawing

[0011] The attached drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown in different drawings may be represented by the same numbers. For clarity, not all components are labeled in all drawings. [Brief explanation of the drawing]

[0012] [Figure 1]

[0012] An example of a breast implant is shown. [Figure 2]

[0013] This shows one embodiment of an implant fixation device. [Figure 3]

[0014] Three embodiments of implants of different sizes and the implant fixation devices used are shown. [Figure 4]

[0015] This shows a rear view of an implant fixation device applied to an implant according to one embodiment. [Figure 5]

[0016] This shows a front view of an implant fixation device applied to an implant according to one embodiment. [Figure 6]

[0017] This shows one embodiment of an implant fixation device applied to an implant. [Figure 7]

[0018] Two embodiments of implant fixation devices applied to different types of implants are shown. [Figure 8]

[0019] Another embodiment of the implant fixation device is shown. [Figure 9]

[0020] Top view of an implant fixation device according to one embodiment. [Figure 10]

[0021] Shows a rear view of an implant fixation device applied to an implant according to one embodiment. [Figure 11A]

[0022] Shows yet another embodiment of the implant fixation device. [Figure 11B]

[0022] Shows yet another embodiment of the implant fixation device. [Figure 11C]

[0022] Shows yet another embodiment of the implant fixation device. [Figure 11D]

[0022] Shows yet another embodiment of the implant fixation device. [Figure 12]

[0023] Top view of an implant fixation device according to one embodiment. [Figure 13A]

[0024] Shows yet another embodiment of the implant fixation device. [Figure 13B]

[0024] Shows yet another embodiment of the implant fixation device. [Figure 13C]

[0024] Shows yet another embodiment of the implant fixation device. [Figure 13D] 【002x】Shows yet another embodiment of the implant fixation device. [Figure 14]

[0025] Shows an exploded view of yet another embodiment of the implant fixation device. [Figure 15A]

[0026] Shows an assembly drawing of the implant fixation device of Figure 14. [Figure 15B]

[0026] Shows an assembly drawing of the implant fixation device of Figure 14. [Figure 16A]

[0027] Shows one of the various views of the breast implant in the implant fixation device of Figures 14 to 15B. [Figure 16B]

[0027] Figures 14 to 15B show one of the various diagrams of breast implants in implant fixation devices. [Figure 16C]

[0027] Figures 14 to 15B show one of the various diagrams of breast implants in implant fixation devices. [Modes for carrying out the invention]

[0013] Detailed explanation

[0028] Among patients considering breast reconstruction and augmentation, an increasing number are hesitant to have permanent breast implants placed in their breasts. This is especially true for women who have undergone mastectomies and are now considering breast reconstruction. When used alone, conventional breast implants made of permanent, non-absorbable materials such as silicone carry risks of complications including potential capsular contracture, implant rupture or contraction, and the development of anaplastic large cell lymphoma (ALCL).

[0014]

[0029] Furthermore, due to the interaction between permanent implants and the surrounding fascia, conventional implants may not be properly fixed after implantation, increasing the risk of movement or displacement over time. For example, permanent breast implants may rotate after implantation, resulting in an unnatural appearance of the breast. In some cases, implants may move after implantation, leading to anatomical asymmetry and impaired appearance. Many of these complications may require corrective procedures, which, in addition to scar tissue accumulation and delayed healing, can be costly and undesirable.

[0015]

[0030] In some cases, the placement of implants can also introduce complications. For example, during the placement procedure, the implant may come into contact with the incision site and become improperly contaminated with blood or other internal organs from the incision site. In some cases, contact between the implant and the incision site may lead to improper healing of the incision or implant site, which can reduce blood flow to the site and result in tissue necrosis.

[0016]

[0031] In recent years, permanent breast implants have been covered with implant wraps before delivery to promote internal tissue growth around the implant, thereby reducing the likelihood of the aforementioned complications. The inventors have recognized that existing wraps may require the surgeon to customize their shape and size to match the desired shape and size of the permanent implant before implantation. This customization can take up to an hour in the operating room, even for a skilled surgeon, extending the procedure time, thus increasing costs and increasing the likelihood of undesirable outcomes. In addition, the customization process may require cumbersome measurement and cutting of the wrap, which necessitates significant contact with the implant before delivery to the implant site.

[0017]

[0032] Furthermore, although not yet approved by the FDA for use in breast reconstruction procedures, some surgeons use wraps composed of acellular dermal matrix (ADM) material, which can be obtained from human tissue in the form of allografts or from animal tissue in the form of decellularized xenografts. The inventors acknowledge that these materials are not absorbable and therefore may cause complications such as infection, necrosis, hematoma, and / or seroma. The inventors also acknowledge that ADM material is elastic and may cause displacement or misalignment of the breast implant over time. In some cases, complications associated with ADM wraps may require additional procedures such as implant revision.

[0018]

[0033] Considering the above, the inventors have recognized the advantages associated with implant fixation devices that can be rapidly applied to implants before delivery. The implant can be significantly reduced in procedure time, improving procedure efficiency. Furthermore, in some cases, the fixation device can be manipulated to minimize contact with the implant before implantation. The fixation device can be formed from a porous, biocompatible material that promotes internal tissue growth. Thus, the device can serve as a template for indigenous cells, vascular systems, and bodily fluids to infiltrate and form biological tissue around the implant. The fixation device may also be formed from an absorbable material that degrades over time as biological tissue forms in its place. The absorbability of the fixation device can reduce the possibility of foreign body reactions and rejection. However, different benefits may be offered by the systems and methods disclosed herein.

[0019]

[0034] In some embodiments, the implant fixation device may be formed from a porous biocompatible material and may include a central portion configured to cover at least a portion of the first surface of the implant, and a peripheral portion extending radially outward from the central portion, configured to cover at least a portion of the second surface of the implant. In embodiments where the implant is a breast implant, the central portion may be positioned 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 rear surface of the implant.

[0020]

[0035] In some embodiments, the implant fixation devices disclosed herein can be configured to move between a first extended form that allows the implant to be positioned in contact with the central portion and a second wrap-around form in which the peripheral portion is wrapped around the back of the implant. In some embodiments, this transition can be achieved by utilizing a tether attached to the peripheral portion. By applying tension to the tether through one or more operating parts, the tether can bundle or gather the peripheral portion around the implant to form a wrap-around form in which the implant fixation device extends at least partially, and possibly completely, around the implant in question. The tether can function similarly to a drawstring for wrapping the fixation device tightly around the implant. This transition can be performed with minimal contact between the surgeon and the implant, thereby reducing the risk of contamination. The surgeon may be able to perform this transition between fixation device forms more quickly than conventional techniques of manually cutting and positioning the implant wrap, thereby improving procedure efficiency.

[0021]

[0036] In some embodiments, the peripheral portion extending from the central portion of the implant fixation device may include one or more tabs that can be fixed to the implant site (e.g., the patient's pectoral muscle or chest wall) to help fix the orientation and position of the implant and fixation device assembly to the patient's anatomical structure during implantation. The tabs may be formed radially across the peripheral portion and may be oriented inward toward the central portion of the device along the portion of the peripheral portion where the tabs are located when the device is in the unfolded configuration and the tabs are in the neutral, unbiased configuration. During use, the tabs may be configured to reorient themselves outward from the central portion as the device transitions to its wrapped configuration. This reorientation of the tabs may occur by the transition of the peripheral portion without any additional effort by the surgeon, although it is also intended that the surgeon or another user may manually reorient the tabs. When the device is in the wrapped configuration around the implant, the tabs may extend outward from the implant and device assembly, thereby allowing the surgeon to easily locate the tabs (e.g., by visual inspection or palpation) and fix the assembly to the patient's anatomical structure.

[0022]

[0037] In some embodiments, when the device is in its deployed state, the tabs may be oriented inward toward the central portion of the device. In other embodiments, when the device is in its deployed state, the tabs may be oriented outward toward the central portion of the device. In yet another embodiment, the tabs may be oriented at an angle to the radial direction of the peripheral portion. In yet another embodiment, a combination of inwardly oriented tabs, outwardly oriented tabs, and angled tabs may be employed.

[0023]

[0038] In some embodiments, the tabs can be formed from the body of the peripheral portion. For example, the tabs may be cut out from the peripheral portion so that a portion of the tab is freely movable relative to the peripheral portion, allowing its orientation to be changed when the device is reconfigured between its unfolded and wound-up forms. In some embodiments, the tabs may be additional material attached to the peripheral portion by a preferred joining technique, as will be described in more detail later.

[0024]

[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 the surgeon to manually cut or modify the prosthetic fabric. The legs may be folded over the body of the implant to conform tightly to the implant during the wrapping process. In embodiments where the fixation device includes tabs, each tab may be formed along its respective leg. In embodiments where the fixation device includes a tether, the tether may be attached to the distal portion of one or more legs to facilitate wrapping the legs around the implant when tension is applied to the tether. The legs may be sized and shaped to adequately cover and support the implant while reducing the possibility of warping and creasing at the implant. As will be described in more detail later, the arrangement of the legs and central portion may allow the fixation device to quickly accommodate multiple implant sizes and shapes without requiring excessive customization by the surgeon. Therefore, surgeons may be able to choose from a set of smaller fixation device sizes (e.g., small, medium, large, extra-large), each of which may be adaptable to a wide range of implant shapes and sizes. In some embodiments, a small set of devices may be able to accommodate at least 90% of the available conventional permanent implant sizes. In other embodiments, a set of devices may be able to accommodate at least 80% of the available conventional permanent implant sizes.

[0025]

[0040] In some embodiments, the peripheral portion of the implant fixation device may be formed in the shape of a continuous rim, extending from the central portion of the device and extending at least partially, and possibly completely, around the central portion of the device. The peripheral rim may function similarly to a leg, in that it can wrap around at least a portion of the implant to promote internal growth of biological tissue. In some embodiments, a tether may be attached to the distal portion of the peripheral rim, and tension can be applied to the tether to help transition the device from an unfolded state to a wrapped state, thereby ensuring close contact with the implant.

[0026]

[0041] As will be described in more detail later, in some embodiments, the maximum diameter of the central portion can be smaller than the base diameter of the associated breast implant, and by wrapping the central portion around the implant, the possibility of wrinkles or warping of the fixation device can be reduced for a more desirable aesthetic result.

[0027]

[0042] In some embodiments, an implant fixation device including a central portion and a peripheral portion may be provided in the form of a substantially two-dimensional patch body when in its deployed state. For example, in some embodiments, when the implant fixation device is placed on a flat support surface in its deployed state, the central portion and the peripheral portion may be located flat in a plane. When the peripheral portion (e.g., a peripheral rim or one or more legs) transitions from a deployed state to a wrap-around state around the implant, the device may be arranged in a three-dimensional configuration that extends in close contact around at least a portion of the implant.

[0028]

[0043] In some embodiments, the central portion of the fixation device can be provided in a substantially three-dimensional form. For example, the central portion may be pre-molded to mimic the curvature of a breast implant (and / or any other suitable implant), and may be shaped and sized to accommodate the implant therein. In some embodiments, the central portion may have a hemispherical shape. A curved central portion may allow the solid device to fit more closely to the breast implant, potentially reducing the possibility of wrinkling and warping.

[0029]

[0044] In some embodiments, the fixation device of this disclosure may be formed from a biocompatible prosthetic fabric, such as a porous mesh material. The pores of the mesh can induce tissue infiltration and the growth of biological tissue around the implant. In some embodiments, the fixation device may be formed from a bioabsorbable material, which can decompose while biological tissue grows throughout the pores. In this way, the fixation device can be gradually replaced by the natural tissue. In other embodiments, the fixation device may be formed from a permanent material, which may be porous and / or textured on its surface to induce tissue growth.

[0030]

[0045] In some embodiments, various features of the fixing device (e.g., central portion, tabs, legs) can be formed from a sheet of repair fabric by any preferred means, including, but not limited to, die-cutting, laser cutting, waterjet cutting, manual cutting, and / or any other preferred forming technique. In embodiments in which some parts of the fixing device are pre-formed into a three-dimensional shape, the sheet of repair fabric can be formed using thermoforming or compression molding techniques, as will be described in detail later.

[0031]

[0046] The disclosed fixation devices can be used for multiple different applications and can offer many different benefits. In some embodiments, the fixation devices can be formed from porous materials to act as a scaffold for tissue infiltration, allowing tissue to grow within the device. The natural tissue can act as a natural shell around the implant, reducing the risk of capsular contracture and potential rejection of the foreign body implant. In this way, the risk of complications can be reduced and surgical outcomes can be improved. Because the natural tissue formed through the pores of the device can grow from and / or be fixed into the natural anatomical space, the internal tissue growth can have the additional benefit of resistance to migration. The formation of natural tissue at the implant site can further reduce the risk of foreign body reaction complications such as capsular contracture. In some embodiments, the fixation device can be wrapped around the implant and attached to the surgical site to reduce contact between the implant and the incision site to which the implant and device assembly are delivered. For example, the fixation device can shield the implant from visceral or bodily fluids at the incision site to reduce the risk of necrosis and contamination. In some embodiments, the fixation devices of this disclosure can be configured to be quickly wrapped around an implant to reduce preparation and customization time during treatment. Thus, surgeons can quickly wrap the fixation devices around various implant types and shapes, ensuring a tight wrap while reducing the possibility of wrinkles and warping. In some embodiments, the fixation devices can be selectively transitioned between an unfolded and a wrapped configuration while limiting contact between the surgeon and the implant. This reduces the possibility of contamination and infection. However, different benefits may be offered by the systems and methods disclosed herein.

[0032]

[0047] The immobilization devices of this disclosure may be formed from biocompatible materials that can promote rapid internal growth of tissue or muscle within and around the device. In some embodiments, the immobilization devices may be formed from absorbable materials that may be replaced in vivo by the patient's biological tissue as the device degrades.

[0033]

[0048] In some embodiments, the device may be formed of an absorbable material (e.g., a polymer or copolymer) that may be substantially reabsorbed within a period of 1 to 24 months, 3 to 18 months, and / or any other preferred period after implantation. 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 preferred period. It should be understood that the fixation devices of this disclosure may retain residual strength throughout any preferred period, depending on the surgical and implant site.

[0034]

[0049] In some embodiments, the immobilization device may contain or include an absorbent polymer prepared therefrom, comprising one or more monomers selected from the group consisting of glycolide, lactide, glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 3-hydroxybutyrate, 4-hydroxybutyric acid, 4-hydroxybutyrate, ε-caprolactone, 1,4-butanediol, 1,3-propanediol, ethylene glycol, glutaric acid, malic acid, malonic acid, oxalic acid, succinic acid, and adipic acid.

[0035]

[0050] In some embodiments, the immobilization device may be formed from poly-4-hydroxybutyrate (P4HB) and its copolymer, or poly(butylene succinate) (PBS) and its copolymer. In embodiments, the P4HB and PBS polymers and their copolymers may not be crosslinked. In embodiments, the PBS polymers and copolymers may further contain one or more of branching agents, crosslinking agents, chain extenders, and reactive blending agents. In some embodiments, the PBS and P4HB polymers and copolymers may be isotope enriched.

[0036]

[0051] The fixation devices of this disclosure can be formed from restorative fabric materials in the form of mesh, woven fabric, nonwoven fabric, knitted fabric, braided fabric, felt fabric, combinations thereof, and / or any other suitable type of restorative fabric. In some embodiments, the restorative fabric material may be porous to allow innate biological substances (e.g., bodily fluids, cells, vascular system) to penetrate the fixation device. The restorative fabric material can be formed from non-limiting 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 necessary, nonwoven fabric materials may be used instead of mesh, or in conjunction with mesh, to give the prosthesis a relatively soft outline.

[0037]

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

[0038]

[0053] In some embodiments, the device may be formed from a permanent material such as a non-biodegradable thermoplastic polymer, including ultra-high molecular weight polyethylene, ethylene and propylene polymers and copolymers including ultra-high molecular weight polypropylene, nylon, polyesters such as poly(ethylene terephthalate), poly(tetrafluoroethylene), polyurethane, poly(ether-urethane), poly(methyl methacrylate), polyetheretherketone, polyolefin, and poly(ethylene oxide). In other embodiments, the device may be formed from a biodegradable material, including but not limited to thermoplastic or polymer biodegradable materials. Combinations of those described above are intended. In some embodiments, the device may be formed from one or more absorbent polymers or copolymers, absorbent thermoplastic polymers and copolymers, and / or absorbent thermoplastic polyesters.The devices include, but are not limited to, glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, polyglycolic acid, polylactic acid, polydioxanone, polycaprolactone, VICRYL® polymer, MAXON® and MONOCRYL® polymers, and other copolymers of glycolic acid and lactic acid, including poly(lactide-co-caprolactone); e-caprolactone; poly(orthoester); polyanhydride; poly(phosphazene); polyhydroxyalkanoate; synthetic or biologically prepared polyester; polycarbonate; tyrosine polycarbonate; polyamide (including synthetic and natural polyamides, polypeptides and poly(amino acids)); polyesteramide; poly(alkylene alkylate); polyether (polyethylene glycol, PEG and polyethylene oxide) , PEO etc.); polyvinylpyrrolidone or PVP; polyurethane; polyether ester; polyacetal; polycyanoacrylate; poly(oxyethylene) / poly(oxypropylene) copolymer; polyacetal, polyketal; polyphosphate; (phosphorus-containing) polymer; polyphosphate ester; polyalkylene oxalate; polyalkylene succinate; poly(maleic acid); silk (including recombinant silk and silk derivatives and analogs); chitin; chitosan; modified chitosan; biocompatible polysaccharides; and polymers comprising hydrophilic or water-soluble polymers such as polyethylene glycol (PEG) or polyvinylpyrrolidone (PVP), which have blocks of poly(lactide), poly(lactide-co-glycolide) or polycaprolactone and its copolymers (including its random copolymers and block copolymers).

[0039]

[0054] In some embodiments, the fixation device may be loaded, filled, and / or coated with a suitable therapeutic composition. This may include coatings, absorbable materials, adsorbent materials, compounds functionally bound to the materials of the fixation device, and / or any other preferred methods for associating the therapeutic composition with the fixation device. Suitable types of therapeutic compositions include, but are not limited to, cells, stem cells, differentiated cells, adipocytes, muscle cells, platelets, stalks, vascular stalks, tissue aggregates, extracellular adipose matrix proteins, gels, hydrogels, hyaluronic acid, collagen, bioactive agents, drugs, antibiotics, and other suitable therapeutic compositions that may be desirable for delivery to the implant site. The cells and tissues that can be delivered to and / or coated or injected into the device may be autologous. The device can be used for autologous fat grafting. Examples of cells to be added to, coated or injected into the device include pancreatic islet cells, hepatocytes, and genetically engineered stem cells containing genes for the treatment of the patient's disease. The device may contain bioactive agents that stimulate the internal growth of cells, including cell signaling molecules such as growth factors, cell adhesion factors, cell differentiation factors, cell recruitment factors, cell receptors, cell binding factors, and cytokines, as well as molecules that promote cell migration, cell division, cell proliferation, and extracellular matrix deposition. The device may also be partially or completely coated with and / or contain agents that inhibit tissue adhesion or inhibit cell proliferation, particularly agents that delay cell entry into the device.

[0040]

[0055] In some embodiments, a bioactive agent may be partially or completely loaded, filled, coated, or otherwise incorporated into the immobilization device. The bioactive agent may be included in the device for a variety of reasons. For example, it may be included to promote internal tissue growth to the implant, to promote tissue maturation, to enable the delivery of the activator, to improve the wettability of the implant, to reduce the risk of infection, and to improve cell adhesion. The bioactive agent may also be incorporated into the material composition of the substrate of the subunit.

[0041]

[0056] The device may contain activators designed to stimulate the internal growth of cells, including growth factors, cell adhesion polypeptides, cell differentiation factors, cell recruitment factors, cell receptors, cell binding factors, cytokines and other cell signaling molecules, as well as molecules that promote cell migration, cell division, cell proliferation and extracellular matrix deposition. Examples of such activators include fibroblast growth factor (FGF), transforming growth factor (TGF), platelet-derived growth factor (PDGF), epidermal growth factor (EGF), granulocyte-macrophage colony-stimulating factor (GMCSF), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), hepatocyte growth factor (HGF), interleukin-1-B (IL-1B), interleukin-8 (IL-8), and combinations thereof. As used herein, the term “cell adhesion polypeptide” refers to a compound having at least two amino acids per molecule that can bind cells via cell surface molecules. Cell adhesion polypeptides include any of the extracellular matrix proteins known to be involved in cell adhesion, including fibronectin, vitronectin, laminin, elastin, fibrinogen, type I, type II, and type V collagen, and synthetic peptides having similar cell adhesion properties. Cell adhesion polypeptides also include peptides derived from any of the aforementioned proteins, comprising fragments or sequences containing binding domains.

[0042]

[0057] In some embodiments, the stationary device may be loaded, filled, coated, or otherwise incorporated with a wetting agent designed to improve the wettability of various surfaces of the device, thereby enabling body fluids to be readily adsorbed onto the device surface, promoting cell adhesion, and / or altering the water contact angle of the device surface. Examples of wetting agents include polyethylene oxide, polypropylene oxide, or copolymers thereof, such as polymers of ethylene oxide and propylene oxide, e.g., PLURONICS®. Other suitable wetting agents include surfactants or emulsifiers.

[0043]

[0058] In some embodiments, to further improve wettability and promote cell proliferation throughout the device, the immobilization device may be loaded, filled, coated, or otherwise incorporated with a gel, hydrogel, or living hydrogel hybrid. The hydrogel hybrid may consist of living cells encapsulated in a biocompatible hydrogel such as gelatin, methacrylated gelatin (GelMa), silk gel, and hyaluronic acid (HA) gel.

[0044]

[0059] Other bioactive agents that can be incorporated into the device include antimicrobial agents, particularly antibiotics, disinfectants, anti-cancer agents, anti-scarring agents, anti-inflammatory agents, anesthetics, small molecule drugs, anti-adhesion agents, cell proliferation inhibitors, anti-angiogenic and pro-angiogenic factors, immunomodulators, and blood coagulants. Bioactive agents may be proteins such as collagen and antibodies, peptides, polysaccharides such as chitosan, alginic acid, hyaluronic acid and their derivatives, nucleic acid molecules, low molecular weight compounds such as steroids, inorganic materials such as hydroxyapatite and ceramics, or complex mixtures such as platelet-concentrated plasma. Preferred antimicrobial agents include bacitracin, biguanides, triclosan, gentamicin, minocycline, rifampin, vancomycin, cephalosporins, copper, zinc, silver, and gold. Nucleic acid molecules include DNA, RNA, siRNA, miRNA, antisense, or aptamers.

[0045]

[0060] In some embodiments, the fixation device may be loaded, filled, coated, or otherwise assembled with allograft and xenograft materials, including cell-free dermal matrix material and the submucosa (SIS) of the small intestine. In some embodiments, the device may incorporate a system for the controlled release of therapeutic or prophylactic agents.

[0046]

[0061] In some embodiments, the fixation device may be loaded, filled, coated, or otherwise incorporated with allograft or xenograft tissues and cells before, during, or after implantation, or any combination thereof. In some embodiments, the device may be coated with patient autologous tissues and cells before, during, or after implantation, or any combination thereof. Examples of autologous tissues and cells include one or more of the following: autologous fat, liposuction, adipose tissue, injectable fat, adipose tissue, adipocytes, fibroblasts, and stem cells including human adipose tissue-derived stem cells, also known as pre-adipocytes or adipose tissue-derived progenitor cells, or fibroblast-like stem cells. In one embodiment, the device may be coated with autologous tissues and cells as described herein and may further include vascular pedicles or other tissue masses.

[0047]

[0062] In some embodiments, the polymer and copolymer compositions of the device may have a low water content to ensure that the device can be manufactured to have rigidity comparable to biological tissue, long-term strength retention, and a good shelf life. In some embodiments, the polymers and copolymers used to prepare the device have a water 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%).

[0048]

[0063] It should be understood that the compositions used to prepare the devices may have a low endotoxin content. In some embodiments, the endotoxin content may be low enough that devices made from the polymer composition have an endotoxin content of less than 20 endotoxin units per device, as determined by a horseshoe crab slime cell lysate (LAL) assay. For example, the polymer composition used to prepare the devices may have an endotoxin content of less than 2.5 EU per gram of polymer or copolymer. In another example, a P4HB polymer or copolymer, or a PBS polymer of a copolymer, has an endotoxin content of less than 2.5 EU per gram of polymer or copolymer.

[0049]

[0064] In some embodiments, the devices of the present disclosure may include one or more markers for detecting the device location from the outside. For example, the device may include radiopaque markers (e.g., metal tags, radiopaque materials) that may be visible and identifiable in comparison to nearby anatomical structures during X-ray imaging. The markers may be formed from any suitable, long-term approved medical material that is medically imagingable. Medical imaging may be performed, for example, using radioimaging modalities (e.g., X-ray imaging), magnetic resonance imaging (MRI), ultrasound, fluoroscopy, or computed tomography. Thus, the markers may be formed from any non-absorbable, biocompatible material, which may refer to a material that does not cause any adverse reactions to the patient's health and does not decompose throughout the patient's lifetime. Examples of non-absorbable, biocompatible materials include, but are not limited to, metal-containing materials, polymer materials, ceramic materials, or composite materials including metals, polymers, or combinations of metals and polymers. Suitable metals include, but are not limited to, gold, iridium, nickel, rhodium, silver, tantalum, titanium, stainless steel and its alloys, combinations thereof, and / or others. Suitable polymers include, but are not limited to, polyvinyl alcohol, polyurethane, polyolefin, polyester, polypropylene, polyimide, polyetherimide, fluoropolymer, thermoplastic liquid crystal polymers (LCPs) such as Celanese's Vectra®, polyethyl ether ketone such as Vitrex's PEEK®, polyamide, polycarbonate such as Bayer Polymers' Makrolon®, polysulfone, polyethersulfone, polyphenylsulfone such as Rowland Technologies' Radel®, nylon, nylon copolymers, combinations thereof, and / or others. In some embodiments, the marker may include, but are not limited to, a shape memory material comprising nitinol, titanium, or any shape memory polymer.

[0050]

[0065] As described above, in some embodiments, soft tissue fixation devices can be used with implants (e.g., permanent or disposable breast implants) for soft tissue regeneration, augmentation, repair, reinforcement, replacement, and / or reconstruction procedures. In breast procedures, fixation devices can be used in combination with implants used in mastectomy, breast lift, partial mastectomy, and breast augmentation. The devices may be biocompatible and, in some cases, absorbable, and as the devices degrade, they may be replaced in vivo by the patient's tissue. In some embodiments, the devices may be coated or filled with materials that induce tissue growth and / or reduce the risk of infection. For example, before, during, or after implantation, the devices may be coated or filled with autologous tissue, autologous fat, liposuction, injectable fat, adipocytes, fibroblasts, and stem cells.

[0051]

[0066] The fixation devices of this disclosure can be used in any suitable application. In some embodiments, the prosthesis can be used in conjunction with an implant (e.g., a soft tissue or hard tissue implant) after treatment for cancers such as breast cancer, abdominal cancer, liver cancer, muscle cancer, kidney cancer, lung cancer, and prostate cancer. In some embodiments, the device can be used for soft tissue reconstruction applications and can wrap around, partially enclose or completely cover, breast implants, breast lift implants, tissue expanders, breast augmentation implants, nipple implants, facial reconstruction implants, buttock implants, cheekbone augmentation devices, cosmetic restoration implants, soft tissue regeneration implants, hernia implants, hernia plugs, wound healing implants, tissue engineering scaffolds, scaffolds for vascular peduncles or other tissue masses, induction tissue repair / regeneration devices, augmentation or filling implants, space fillers, implants for treating vesicourethral reflux, cell seeding devices, drug delivery devices, cardiac rhythm management devices (CRMs), pacemakers, defibrillators, pulse generators, implantable access systems, muscle and nerve stimulators, cochlear implants, ventricular assist devices, gastric stimulators, infusion pumps, drug pumps, nerve stimulators, vagus nerve stimulators, spinal nerve modulators, deep brain stimulators, sacral nerve stimulators, combinations thereof, and / or any other suitable applications. In this embodiment, the implant has a shape and size suitable for use in breast surgery procedures, including breast augmentation, breast reconstruction, and breast lift.

[0052]

[0067] As used herein, "absorbable" generally means that a material is broken down in the body, and its breakdown products are excreted or eliminated from the body. The terms "absorbable," "reabsorbable," "degradable," and "erosive" may be used synonymously herein to describe materials that are broken down in the body and gradually absorbed, excreted, or eliminated, with or without the prefix "bio," regardless of whether the breakdown is primarily by hydrolysis or through metabolic processes.

[0053]

[0068] As used herein, “bioactive agent” generally refers to therapeutic agents, prophylactic agents or diagnostic agents, agents that promote the healing and regeneration of host tissues, and therapeutic agents that reduce the risk of infection. “Agent” includes a single such agent, but is also intended to include multiple such agents.

[0054]

[0069] As used herein, "biocompatibility" means that the biological response to a material or device is appropriate for the device's intended use in a living organism. Any metabolites of these materials should also be biocompatible.

[0055]

[0070] As used herein, "blend" generally refers to a physical combination of different polymers, as opposed to a copolymer formed from two or more different monomers.

[0056]

[0071] In this specification, "breast implant" as used generally refers to any permanent, non-permanent (e.g., disposable), or combination thereof implant used in breast reconstruction procedures.

[0057]

[0072] As used herein, “poly-4-hydroxybutyric acid copolymer” means any polymer containing 4-hydroxybutyric acid having one or more distinct hydroxy acid units. The copolymer may be isotopically enriched.

[0058]

[0073] As used herein, “poly(butylene succinate) copolymer” means any polymer containing 1,4-butanediol and succinic acid units, and one or more different diol or diacid units. The copolymer may contain one or more branching agents, crosslinking agents, chain extenders, and reactive blending agents. The copolymer may be isotopically enriched.

[0059]

[0074] As used herein, "endotoxin content" generally refers to the amount of endotoxin present in the implant or sample, determined by a horseshoe crab slime cell lysate (LAL) assay.

[0060]

[0075] In this specification, "poly-4-hydroxybutyrate" as commonly used means a homopolymer containing 4-hydroxybutyrate units. This may be referred to herein as P4HB or TephaFLEX® biomaterial (manufactured by Tepha, Inc., Lexington, Mass.). The polymer may be isotopically enriched.

[0061]

[0076] As used herein, “tether” may refer to any generally flexible one-dimensional structure formed from one or more yarns, fibers, cords, ribbons, strands, threads, sewn cords, monofilaments and / or multifilaments. Such structures may include knitted fabrics, braids, woven materials, nonwoven materials, combinations thereof and / or any other suitable shape. The cord materials of this disclosure may be formed from any suitable biocompatible material or combination of materials, which may be bioabsorbable and / or non-bioabsorbable.

[0062]

[0077] With reference to the drawings, certain non-limiting embodiments will be described in further detail. Since this disclosure is not limited to the certain embodiments described herein, it should be understood that the various systems, components, features and methods described with respect to these embodiments can be used individually and / or in any desired combination.

[0063]

[0078] Figure 1 shows an exemplary permanent implant 10 that can be used in conjunction with the fixation device of this disclosure. The implant 10 can be formed from a non-absorbable material such as silicone. In embodiments where the implant is a breast implant, the implant can be molded to be substantially hemispherical, as shown in Figure 1, and to have a maximum base diameter D1 or similar maximum lateral dimension and effective profile height H1. The base diameter can be any suitable size depending on the patient's bioanatomical structure and the desired resulting shape of the implant. For example, the maximum base diameter D1 can include, but is not limited to, about 6 cm, 8 cm, 10 cm, 12 cm, 15 cm, 18 cm, 20 cm, 22 cm, and / or about 22 cm, 20 cm, 18 cm, 15 cm, 12 cm, 10 cm, 8 cm, 6 cm or less, and / or any other suitable maximum diameter. Combinations of the above ranges are intended, including maximum base diameters of about 6 cm to 22 cm, 8 cm to 18 cm, and / or ranges larger and smaller than the aforementioned ranges. Similarly, the implant profile height can be any suitable dimension to adapt to the patient's anatomical structure and the desired implant shape. Exemplary profile heights H1 include, but are not limited to, 2cm–15cm, 3cm–10cm, 4cm–7cm, combinations thereof, and / or any other suitable size.

[0064]

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

[0065]

[0080] Figure 2 shows the fixation device 100 in an unfolded two-dimensional form according to several embodiments. The device 100 may include a peripheral portion, in which one or more legs 110 extend radially outward from the central portion 111. In some cases, the multiple legs extending outward from the central portion may be distributed around the periphery of the central portion. As will be described in more detail later, the legs 110 may be sized to surround a portion of the implant (e.g., a breast implant) to help fix the implant to the patient's anatomical structure. The central portion 111 may be sized to cover a portion of the implant (e.g., a portion of the curved surface of a breast implant).

[0066]

[0081] In some embodiments, the central portion 111 may have a maximum diameter D2, or other suitable maximum lateral dimension, which may be smaller than the maximum diameter of the implant D1, as shown in Figure 2. This difference in diameter creates a gap 112 between the legs 110, which allows the legs to wrap around the implant with minimal risk of wrinkling or warping. In some embodiments, the presence of a gap 112 between the legs 110 may also allow the device 100 to wrap around various implants of different sizes. Thus, the ratio of the maximum diameter D2 of the central portion to the implant diameter D1 can be any preferred ratio of 1 or less. In some embodiments, the central portion of the implant fixation device may be substantially aligned with the central portion of an adjacent surface of the implant.

[0067]

[0082] As shown in Figure 2, the peripheral legs 110 can extend radially outward from the central portion 111. While six legs are shown, each extending an equal distance from the central portion, it should be understood that embodiments in which the legs are asymmetrically distributed around the central portion, and embodiments having more or fewer than six legs, are also contemplated. For example, an implant fixation device includes three legs. When in an unfolded, flat configuration, a virtual circle with diameter D3 can circumscribe the legs, and this diameter D3 can be referred to as the diameter of the device or the maximum lateral dimension, as shown in the figure. In some embodiments, the diameter D3 can be large enough to allow one or more legs 110 to extend from a first surface (e.g., the rounded surface of the breast implant) to a second surface (e.g., the flat surface of the breast implant) to partially or completely wrap around or partially or completely cover the implant. Thus, the maximum diameter D3 of the device may be larger than the maximum diameter D1 of the implant, as shown in Figure 2. Diameter D3 may also be small enough to reduce the risk of significant material overlap while wrapping around the implant.

[0068]

[0083] In some embodiments, the maximum diameter D3 of the device can be selected according to the implant diameter, which may vary depending on the patient's needs, as described above. The maximum diameter D3 of the device can be any suitable size that is appropriate to the implant diameter, including but not limited to about 110%, 120%, 130%, 150%, 180%, 200%, 220%, 250%, 280%, 300% or more, combinations thereof, and / or about 300%, 280%, 250%, 220%, 200%, 180%, 150%, 130%, 120%, 110% or less, combinations thereof, and / or any other proportion of the implant diameter D1.

[0069]

[0084] In some embodiments, each leg 110 may include at least one tab 115, as shown in Figure 2, the tab 115 being positioned between the central portion 111 and the distal end portion of the leg where the at least one tab is located. In some embodiments, multiple tabs may be associated with multiple legs. For example, each leg may include one or more tabs attached to the associated leg using any suitable attachment and / or integral molding with the leg. The tabs 115 can help maintain the device in place relative to the anatomical structure by allowing the device to be fixed to the patient's anatomical structure. In the case of breast reconstruction, the device may be fixed to the patient's pectoral muscle wall.

[0070]

[0085] In the deployed form of device 100, each tab can be positioned within or parallel to the two-dimensional plane of its respective leg. Tabs 115 can be attached to the leg in such a way that each tab can be deformed to face outward from the plane of the leg. For example, as shown in Figure 2, the tabs can be formed by making incisions along the body of the leg to form a tab that, in the deployed form, includes a distal portion relative to the central portion of the device and is attached to the leg. In some embodiments, the tabs may be formed separately from the leg (e.g., as a separate prosthetic mesh material) and may be attached to the leg at the distal portion of the tab. As will be described in more detail later, the tabs can move between a first orientation facing toward the central portion 111 in the deployed form and a second orientation facing outward from the central portion when the device is wrapped around an implant.

[0071]

[0086] As described above, in some embodiments, the tab 115 may be formed directly along the leg portion 110. For example, the tab 115 may be cut off from the leg portion by any preferred technique, including, but not limited to, scissors, blades, other sharp cutting tools, or thermal knives, laser cutting techniques, die-cutting techniques, water jets, manual cutting, combinations thereof and / or any other preferred techniques. In other embodiments, the tab may be formed separately and attached to the leg portion by any preferred method, including, but not limited to, heat sealing, welding (e.g., ultrasonic or other methods), adhesive bonding, suturing, combinations thereof and / or any other preferred techniques.

[0072]

[0087] Regardless of the tab formation type, it should be understood that the tabs can be positioned such that, in their deployed state, the proximal portion of the tab, which can be freely movable, faces toward the central portion of the device, and thus can be reoriented when the device is wrapped around an implant. As shown in Figure 2, the tabs can face toward the central portion in their first orientation when the device is in its deployed state. As will be described in more detail later, when the device is positioned around the implant in a wrapped state, the tabs can extend outward from the device and face away from the central portion. The surgeon can then use these outwardly oriented tabs to secure the device to the patient's anatomical structure.

[0073]

[0088] It should be understood that the tabs may be positioned at any location along each of their legs. In some embodiments, as shown in Figure 2, the tabs may be positioned approximately in the center of the leg so as to extend between the central portion 111 of the device and the distal end of the leg. In other embodiments, the tabs may be positioned closer to the distal end portion of the leg than to the central portion. In yet another embodiment, the tabs may be positioned closer to the central portion than to the distal end portion of the leg. It should be understood that the position of the tabs relative to the leg may facilitate the wrapping of one or more implant sizes. Therefore, this disclosure is not limited by the position of the tabs in the leg.

[0074]

[0089] The tabs can have any preferred size relative to each of their legs. In embodiments where the tabs are formed from the leg body, the tabs can have a width smaller than the width of the leg body. In embodiments where the tabs are formed from a material connected to the leg body, the tab width may be approximately equal to the width of the leg and / or smaller than the width of the leg. It should be understood that this disclosure is not limited by the shape or size of the tabs.

[0075]

[0090] Figure 2 shows that each leg 110 has a tab 115. In some embodiments, the device may include one or more legs with tabs and one or more legs without tabs. The arrangement of the tabs may be determined by how the surgeon plans to secure the device to the patient's anatomical structure. Thus, the device may include any preferred number of tabs equal to and / or less than the number of legs. Furthermore, the case where a single leg includes multiple tabs is also contemplated.

[0076]

[0091] Figure 2 shows six symmetrical legs, but embodiments with more than six legs and embodiments with fewer than six legs are contemplated. In some embodiments, the legs do not have to be symmetrically distributed around the central portion. For example, the device may have more legs in the portion of the device corresponding to the lower pole of the breast implant to provide greater structural support in response to gravity. Although the legs in Figure 2 are shown to be substantially similar in size and shape, it should be understood that embodiments with legs of different sizes / shapes are contemplated, as this disclosure is not limited by the number, size, shape and / or arrangement of the legs relative to the central portion.

[0077]

[0092] In some embodiments, the device 100 may include a tether 120 attached to the distal end of one or more legs 110, as shown in Figure 2. The tether 120 can enable the surgeon to transition the device from its deployed form to its wrapped form without having to manually fold or position each leg around the implant. The tether can function as a pull cord, allowing the surgeon to quickly wrap the device around the implant by applying tension to the tether 120. In some embodiments, the tether may include an operating portion 125, which allows tension to be applied to the tether and the device to be wrapped around the patient. The tether 120 may be attached to the legs 110 in one or more regions 122. This attachment may allow the tether to move axially relative to the legs so that tension can be applied to the tether, but it does not have to be fixed to the legs. For example, the tether may pass through one or more pores in the porous material of the legs 110. As shown in Figure 2, in some embodiments, at least one end of the tether 120 may include a needle 128 to facilitate weaving or connecting the tether 120 to the leg. Alternatively, since the disclosure is not limited thereto, other methods may be used to slidably attach the tether to the leg.

[0078]

[0093] The tether may be formed from a flexible material that can be woven into the leg or otherwise connected to the leg, but it should be understood that it may also be sufficiently inelastic to reduce the possibility that excessive axial stretching could interfere with the proper wrapping of the device. In some embodiments, the tether 120 may be formed from polypropylene suture.

[0079]

[0094] Although the tether 120 is shown to be woven into the distal portion of the leg 110, it should be understood that the tether may be attached to any part or combination of any part of any of the legs of this disclosure so as to allow the implant to be wrapped around the tether when tension is applied to the tether.

[0080]

[0095] Figure 3 shows three sizes of fixation devices formed from porous biocompatible material along with exemplary permanent implants. Fixation device 100A represents a small device corresponding to a small permanent implant 10A, fixation device 100B represents a medium device corresponding to a medium permanent implant 10B, and fixation device 100C represents a large device corresponding to a large permanent implant 10C. As shown in Figure 3, in some embodiments, the devices may include tabs 115C positioned along the legs of the device to facilitate fixation of the device to the patient's anatomical structure. Implants can be characterized as follows: they are “small” if they have a maximum base diameter of about 9–12 cm and a profile height of about 3.5–5 cm; they are “medium” if they have a maximum base diameter of about 11–14 cm and a profile height of about 4.5–6 cm; they are “large” if they have a maximum base diameter of about 12–15.5 cm and a profile height of about 5–7 cm; and they are “extra-large” if they have a maximum base diameter of about 13–17 cm and a profile height of about 3–7 cm. The classification of implant sizes is illustrative, and it should be understood that the fixation devices described herein can be used with breast implants of any size.

[0081]

[0096] The fixation device 100C in Figure 3 is shown in its deployed state, with each leg radiating outward from a central portion (covered by the implant 10C). As shown, when the device 100C is in the deployed state, the tab 115C is oriented such that its proximal portion faces the central portion relative to the distal end portion of the associated leg.

[0082]

[0097] Figure 4 shows a rear view of the implant fixation device 100 in a wrapped configuration, folded over the implant 10. To achieve this configuration, as previously described, tension is applied to the tether 120, allowing the legs 110 of the device 100 to be brought together in one place on the opposite side of the implant. Applying tension to the tether on the opposite side of the implant allows it to bring the legs together and act as a drawstring for wrapping the device around the implant. In some embodiments, the tether 120 can be used to suture the distal end of the legs before delivery. In some embodiments, the tether 120 may be knotted to maintain the tensed configuration of the tether and the wrapped configuration of the legs. By changing the configuration and arrangement of the legs 110 of the device, the free end of the tab 115 can be oriented so that the tab faces outward from the central portion (covered by the implant 10 in Figure 4). After delivery, the surgeon can fix the implant and device assembly to the patient's anatomical structure via one or more tabs 115.

[0083]

[0098] It should be understood that in some embodiments, the implant 10 can be delivered to the implant site (e.g., intrathoracic cavity) by being at least partially wrapped around the device 100. In this way, the device can protect or otherwise cover the implant from contact with the incision site and / or excessive contact by the surgeon, minimizing the risk of undesirable contamination.

[0084]

[0099] Figure 5 shows a front view of an implant 10 with the implant fixation device 100 wrapped around it and placed on the patient's chest wall or pectoral muscle 20. As shown, the central portion 111 of the device 100 can cover a portion of the breast implant 10 to promote internal tissue growth around the implant. The legs 110 can be wrapped around the other side of the implant to shift the tab 115 outward from the central portion. Thus, the tab can extend outward from the device when placed on the patient's anatomical structure. In this way, the tab 115 can enable the surgeon to fix the device 100 to the patient's anatomical structure. In some embodiments, the tab 115 may be sutured 119 to the chest 20 as shown in Figure 5. In other embodiments, other fasteners may be employed, including but not limited to staples, tucks, hooks, adhesives, and combinations thereof. In some embodiments, each tab 115 may be fixed to the anatomical structure 20 as shown in Figure 5, and in other embodiments, a subset of tabs may be fixed to the anatomical structure. The surgeon can choose to secure the device to an anatomical structure via any one or more of the device's tabs.

[0085]

[0100] Figure 5 shows that the fixing device 100 has tabs 115 formed within the body of the leg portion 110. Therefore, as shown in Figure 5, when the device is in a wrap-around configuration, the tabs 115 may extend from the plane of the leg portion, leaving openings 118. These openings may not be present in embodiments where the tabs are formed separately and attached to the device or connected by other means.

[0086]

[0101] As described above, the legs 110 can form a gap 112 between adjacent legs, allowing the device 100 to conform to the curvature of the implant 10, thereby reducing the risk of wrinkles and undesirable texture deformation in the implant. The gap 112 can also allow the device to wrap around a number of implant sizes without the need to repeatedly customize the shape and size of the fixation device for the implant. This process can facilitate surgical procedures and improve outcomes.

[0087]

[0102] Figure 6 shows an exemplary fixation device 100 wrapped around an implant 10. The fixation device includes six tabs 115 that extend outward from the central portion of the device in the wrap configuration, allowing the surgeon to secure the implant and device assembly to the patient's anatomical structure. As shown, the tabs 115 may be formed along the leg of the device, leaving an opening 118 when positioned in the wrap configuration.

[0088]

[0103] Figure 7 shows two separate fixation devices 100 of the same design, wrapped around two separate implants 10D and 10E with different profile heights. As shown, the spacing between the legs of the fixation devices allows the device to accommodate implants of different sizes (e.g., profile height or base diameter in the case of breast implants) without the need to change the shape of the device. In this way, the fixation device can be standardized to accommodate a variety of implants within a desired size range. As previously mentioned, in some embodiments, the device can be formed in various standard sizes (e.g., small, medium, large, extra-large) to accommodate a wide range of breast implants. In some embodiments, the various fixation devices can cover 90% of conventional breast implant sizes.

[0089]

[0104] Figure 8 shows another embodiment of the implant fixation device 200. The fixation device 200 may include a central portion 211 for accommodating a breast (and / or other soft tissue) implant. The central portion 211 can be pre-formed with a curvature such that the central portion is sized and shaped to at least partially conform to the front-facing surface of the breast implant. In some embodiments, the device 200 of Figure 8 can provide a higher spatial coverage of the breast implant compared to the device 100 of Figures 2-7. The curvature of the central portion 211 can reduce the possibility of wrinkles or other surface deformation resulting from close contact with the underlying breast implant.

[0090]

[0105] In some embodiments, the central portion 211 can be thermoformed and / or compression-molded to form and maintain a generally three-dimensional shape before being wrapped around the breast implant. Thus, the unfolded form of the device 200 may not be substantially two-dimensional in its unfolded form, as in the case of device 100 in Figures 2 to 7. Any preferred conventional molding technique may be employed. For example, the device 200 may be formed from a thermoplastic two-dimensional porous reconstructive fabric, which can be placed in a mold having the curvature of the breast implant, and the mold may be subjected to thermal or compressive forces to help maintain the mold's shape. In some embodiments, the device may be quenched or otherwise treated to enhance certain properties of the material. Since this disclosure is not limited by the molding technique, it should be understood that any preferred molding or molding technique can be used to bring about the curvature of the central portion.

[0091]

[0106] As shown in Figure 8, the implant fixation device 200 may include a peripheral rim 213 that extends outward from the outer periphery of the central portion 211 and at least partially, and possibly completely, around the outer periphery of the central portion 211. During exemplary procedures, the breast implant can be positioned inside the central portion 211, and any possible curvature of the implant can be aligned with the device, and the peripheral rim 213 can be wrapped around the back of the implant. The rim 213 can function similarly to the legs of device 100 in Figures 2-7 in that it can serve to hold the implant within the fixation device. The peripheral rim 213 can be wrapped around the implant and positioned to form a shell or cover for the implant.

[0092]

[0107] In some embodiments, the central portion 211 may have a maximum diameter D4 that can accommodate the implant. Thus, the maximum diameter D4 of the device 200 may be approximately equal to or slightly smaller than the maximum diameter D1 of the implant, as shown in Figure 1. It should be understood that, so that the maximum diameter D4 of the central portion 211 may be less than or equal to the implant diameter D1, the central portion 211 may contain at least some elasticity and may be slightly expandable by applied force. Similarly, the device 200 may have a profile height H1 that is substantially equal to or slightly smaller than the profile height H1 of the implant, as shown in Figure 1. Naturally, embodiments in which the device profile height is slightly greater than the implant profile height are also conceivable.

[0093]

[0108] The peripheral rim 213 of device 200 may have a maximum diameter D5 that corresponds to the maximum diameter D3 of the device shown in Figure 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 to the middle of the base diameter. Thus, the peripheral rim diameter D5 may be approximately equal to twice the central portion diameter D4. The peripheral rim diameter D5 may be any preferred proportion of the central portion diameter D4, including, but not limited to, about 125%, 150%, 180%, 200%, 250%, 300%, and / or about 300%, 250%, 200%, 180%, 150%, 125%, combinations thereof, and / or any other suitable proportion of the central portion diameter D4.

[0094]

[0109] Since this disclosure is not so limited, it should be understood that the implantable device may have any preferred size and geometric shape (e.g., central diameter, profile height, etc.) to adapt to a desired implant size. Although the peripheral rim is shown to be radially symmetrical around the central portion 211, it should be understood that embodiments in which the rim is asymmetrical around the central portion are also contemplated.

[0095]

[0110] Figure 9 shows the device 200 according to several embodiments. The device 200 can be formed from a porous biocompatible material and may include a central portion 211 having a generally rounded shape to adapt to the curvature of an implant (e.g., a permanent breast implant) and a peripheral rim 213. Figure 9 shows the device 200 in its unfolded form before assembly with the implant. As shown in the figure, the device may have a generally three-dimensional shape before assembly.

[0096]

[0111] Figure 10 shows a device 200 similar to that shown in Figure 9, assembled with a silicone breast implant. To provide an external cover for the implant, the peripheral rim 213 of the device can be wrapped around the implant. In some embodiments, a tether 120 may be employed to help reposition the peripheral rim 213 from the unfolded configuration (shown in Figure 9) to the wrapped configuration in Figure 10. The tether 120 may include an operating portion 125 that allows the surgeon to apply tension to the tether and wrap the implant with the fixation device without having to manually manipulate the rim. As previously mentioned, the tether may be woven into the outer portion of the peripheral rim of the fixation device or otherwise connected to facilitate a pull-string effect.

[0097]

[0112] Figures 11A to 11D show fixation devices 300 according to several 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 the breast implant. In some embodiments, the central portion 311 may be provided in a pre-formed shape. The central portion may be pre-formed using any preferred technique, such as the technique described in relation to device 200 in Figure 8. Figures 11A and 11B show the device 300 partially placed on the implant 10. As shown, the central portion 311 of the device 300 can conform to the curvature of the implant 10 to reduce the possibility of wrinkles or other undesirable structural deformation.

[0098]

[0113] In some embodiments, the maximum diameter of the central portion 311 of the device 300 may be smaller than the maximum diameter of the implant 10, allowing the leg portions 310 to partially extend over the curved anterior surface of the breast implant, as shown in Figure 11A. Therefore, a portion of the leg portions 310 may be pre-formed into a curved shape, as shown. As previously mentioned, the spacing 312 between the leg portions allows the device 300 to accommodate various different implant types.

[0099]

[0114] In some embodiments, the device can be adjusted to improve the tight fit of the central portion. For example, the device may include one or more holes 319 extending from the outer surface of the device, oriented away from the implant, to the inner surface, oriented towards the implant, when the implant is placed therein. A suture can be passed through the hole, and then tension can be applied to the suture to tighten or otherwise adjust the central portion relative to the implant. In some embodiments, the holes 319 may be macroholes specifically designed to facilitate the adjustment of the central portion, or in some embodiments, the holes 319 may represent one or more holes in the restorative fabric on which the device is formed. Similarly, the device may include one or more holes 317 on the leg portion 310, through which a suture can be passed to facilitate the repositioning of the device from its unfolded configuration shown in Figures 11A and 11B to its rolled configuration shown in Figures 11C and 11D. It should be understood that the holes 319 may be macroholes located in the leg portion, or in some embodiments, may be a subset of holes in the porous substrate on which the device is formed. As previously stated with respect to devices 100 and 200, the fixation device 300 can be repositioned into the wrap-around configuration shown in Figures 11C and 11D to help cover the implant and provide a biocompatible scaffold for internal tissue growth.

[0100]

[0115] Figure 12 shows an exemplary fixation device 300 formed from 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. Figure 12 shows the device 300 in a deployed state before placement on an implant. In this deployed state, the device may be three-dimensional due to the curvature of the central portion 311. As previously described with respect to the fixation device 100, the device 300 may have any preferred number of legs 310 in any preferred arrangement (e.g., symmetrical or asymmetrical) around the central portion to help distribute the load on the implant. To provide a biocompatible scaffold for tissue growth, the legs 310 of the device 300 can be quickly wrapped around the implant using a tether (not shown).

[0101]

[0116] Figures 13A to 13D illustrate the process of wrapping the implant fixation device 400 around the implant 10 according to several embodiments. The device 400 may include a central portion 411 configured to wrap around the curved front portion of the permanent implant 10, and a series of radially spreading legs 410 arranged around the central portion 411. The legs 410 may be positioned to extend around the implant 10 to the flatter, posterior portion of the implant. In some embodiments, as shown in Figure 13A, the legs 410 may include a series of sets, each containing 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, and an intermediate diameter D7 measured radially around the point where each leg 410A, 410B branches outward from its pair. Since this disclosure is not limited by the geometric shape of the legs 410, it should be understood that any preferred ratio between the central diameter D6 and the intermediate diameter D7 can be adopted. In some embodiments, the fixation device may include a tether 120 that can be pre-threaded onto the leg portion 410, as shown in Figure 13. The tether 120 may have a free distal end that can be tensed to help wrap the leg portion 410 around the implant 10.

[0102]

[0117] In some embodiments, the process of wrapping the fixation device 400 around an implant may include first unfolding the device 400, as shown in Figure 13A. Then, as shown in Figure 13B, the implant 10 can be placed on the central portion 411 of the device 400. The 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 into the wrapped configuration, as shown in Figures 13C and 13D. As shown in Figure 13C, a portion of the leg 410 may be positioned around the curved surface of the implant 10, and the remaining portion of the leg 410 may be positioned on the back side of the implant, as shown in Figure 13D. In some embodiments, the tether 120 may be secured by knotting or other means to reduce the risk of the tether coming undone and returning the fixation device to the unfolded configuration.

[0103]

[0118] The implant fixation devices 400 shown in Figures 13A to 13D can accommodate implants 10 of any size, including any of the aforementioned ranges of implant sizes. For example, the fixation device can be used with 250cc or 350cc implants.

[0104]

[0119] Figure 14 shows exploded views of implant fixation devices 500 according to several embodiments. The device 500 can be formed from three components, including a central portion 501 configured to wrap around the central curved portion of the fixation device, and two rear portions 502, 503 configured to wrap around the flatter rear portion of the implant. In some embodiments, the central portion 501 can be formed to be generally circular, as shown in Figure 14, but other non-circular geometric shapes are also intended. The rear portions 502, 503 may be formed as partial circles. In some embodiments, the rear portions may be larger than semicircles so that the rear portions can overlap each other when the device 500 is assembled.

[0105]

[0120] Figures 15A and 15B show the device 500 of Figure 14 assembled with sutures or thread 120. The sutures 120 spread out around the central and posterior portions, creating pockets therein. The implant can be inserted into the device through the opening between the overlapping posterior portions. Figure 15A shows a bottom view of the assembled device 500, showing the overlapping posterior portions 502 and 503. Figure 15B shows a top view of the device 500, with the central portion 501 extending across the entire front of the device 500.

[0106]

[0121] Figures 16A to 16C show the implant fixation device 500 from Figures 14 to 15B wrapped around the implant 10, and the implant 10 may be partially visible in the top view of Figure 16A. As previously mentioned, the implant can be inserted into the pocket between the central portion 501 and the posterior portions 502 and 503 through a slot formed between the two posterior portions that can be seen in the bottom view of Figure 16B. Figure 16C shows a perspective view of the implant 10 placed on the device 500 and the suture 120 extending around the outer circumference of the device 500.

[0107]

[0122] Although the device 500 in Figures 14–16C is shown to be formed from three material sheets, embodiments formed from fewer or more sheets are also contemplated. For example, a single pre-formed sheet of porous absorbent material may be used to wrap around the front and back of the implant.

[0108]

[0123] Some figures relating to embodiments of three-dimensional pre-molded implant fixation devices do not include fixation tabs, but it should be understood that tabs described with respect to Figure 2 may be employed in any of the fixation devices described herein, including on the leg and periphery rim of the three-dimensional pre-molded implant described above. However, in some embodiments, the fixation device may not include fixation tabs, and a portion of the device may be fixed directly to the patient's anatomical structure.

[0109]

[0124] The foregoing description of various embodiments is intended to be merely illustrative, and other embodiments, modifications, and equivalents are within the scope of this disclosure.

[0110]

[0125] As used herein and in the claims, the indefinite articles “a” and “an” should be understood to mean “at least one” unless otherwise explicitly indicated. As used herein and in the claims, the phrases “and / or” should be understood to mean “either or both” of the elements thus combined, that is, elements that exist conjunct in some cases and disjunct in others. Multiple elements listed using “and / or” should similarly be interpreted as “one or more” of the elements thus combined. Other elements besides those specifically identified by the “and / or” clauses may also exist optionally, whether related to or unrelated to those specifically identified elements.

[0111]

[0126] The use of “including,” “comprising,” “having,” “containing,” or “involving” and / or variations thereof in this specification means to include additional items (and their equivalents) in addition to the items listed above.

[0112]

[0127] The embodiments described herein can also be embodied as methods, and an example of such a method is provided. The actions performed as part of the method can be sequenced in any preferred manner. Thus, embodiments in which the actions are performed in a different order from the exemplified order may be constructed, and these embodiments, although shown as a series of actions in the exemplary embodiments, may also include performing several actions simultaneously.

[0113]

[0128] While this instruction has been described in conjunction with various embodiments and examples, it is not intended to be limited to such embodiments or examples. On the contrary, this instruction encompasses various alternative forms, modifications, and equivalents, as will be understood by those skilled in the art. Accordingly, the foregoing description and drawings are for illustrative purposes only.

[0114]

[0129] While several embodiments of the present invention have been described and illustrated herein, those skilled in the art will readily conceive of various other means and / or structures for carrying out the functions described herein and / or obtaining one or more of the results and / or benefits described herein. Each of such variations and / or modifications will be considered within the scope of the present invention. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials and configurations described herein are intended to be illustrative, and that the actual parameters, dimensions, materials and / or configurations will depend on the specific one or more applications in which the teachings of the present invention are used. Those skilled in the art will be able to recognize or confirm many equivalents to the specific embodiments of the present invention described herein by means of routine experimentation alone. Therefore, it should be understood that the embodiments described herein are presented merely as examples, and within the scope of the appended claims and their equivalents, the present invention may be carried out in ways other than those specifically described and claimed. The present invention relates to each of the individual features, systems, articles, materials, kits and / or methods described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the present invention, provided that they are not mutually inconsistent.

Claims

1. An implant fixation device for fixing an implant inside a patient's body, A central portion having a size and shape that at least partially covers the first surface of the implant, The peripheral portion extends radially outward from the aforementioned central portion, Equipped with, An implant fixation device wherein the peripheral portion includes at least one tab extending radially toward the central portion in a first orientation when the implant fixation device is in a first deployed state, and the device is formed of a porous biocompatible material.

2. The implant fixation device according to 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 wrap-around configuration.

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

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

5. The implant fixation device according to claim 4, wherein each of the multiple tabs is located on a separate leg among the multiple legs.

6. The implant fixation device according to claim 1, wherein the central portion is substantially two-dimensional when the device is in the first deployed state.

7. The implant fixation device according to claim 1, wherein the central portion is pre-molded into a substantially three-dimensional shape configured to receive the implant.

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

9. The implant fixation device according to claim 1, further comprising a tether connected to the peripheral portion, wherein tension is applied to the peripheral portion so as to pull it radially inward when the implant fixation device is in a second wrap-around configuration, thereby at least partially enclosing the implant between the central portion and the peripheral portion.

10. The implant fixation device according to claim 1, which is formed of poly-4-hydroxybutyrate.

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

12. A method for manipulating an implant fixation device, Positioning the central portion of the device so as to at least partially cover the first surface of the implant, The wrapping of the peripheral portion of the device so as to at least partially cover the second surface of the implant, wherein the peripheral portion extends radially outward from the central portion, Moving one or more tabs attached to the peripheral portion from a first orientation facing towards the central portion to a second orientation facing outward from the central portion, Fixing one or more of the aforementioned tabs to the implant site, Methods that include...

13. The method according to claim 12, wherein wrapping the peripheral portion of the device includes applying tension to a tether connected to the peripheral portion such that the peripheral portion is pulled radially inward, so as to at least partially encapsulate the implant between the central portion and the peripheral portion when the implant fixing device is in a second wrapped configuration.

14. The method according to claim 12, further comprising implanting the implant fixation device and the implant assembly into the thoracic cavity through the incision site before fixing the one or more tabs to the implant site.

15. The method according to claim 12, wherein the peripheral portion includes a plurality of legs, and each of the one or more tabs is positioned on one of the plurality of legs.

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

17. An implant fixation device for fixing an implant inside a patient's body, A central portion having a size and shape that at least partially covers the first surface of the implant, When the implant fixation device is in the first deployed state, the peripheral portion extends radially outward from the central portion, A tether connected to the peripheral portion, wherein the tether is configured to apply tension to the peripheral portion in a radially inward direction so as to at least partially enclose the implant between the central portion and the peripheral portion when the implant fixing device is in a second wrap-around configuration, and the device is formed of a porous biocompatible material. An implant fixation device equipped with the following features.

18. The implant fixation device according to claim 17, wherein the tether is woven into the hole in the peripheral portion.

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

20. The implant fixation device according to claim 17, further comprising at least one tab extending radially toward the central portion in the first orientation when the implant fixation device is in the first deployed state.

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

22. The implant fixation device according to claim 17, wherein the central portion is substantially two-dimensional when the device is in the first deployed state.

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

24. The implant fixation device according to claim 17, wherein the central portion is pre-molded into a substantially three-dimensional shape configured to receive the implant.

25. The implant fixation device according to claim 17, which is formed of poly-4-hydroxybutyrate.

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

27. A method for manipulating an implant fixation device, Positioning the central portion of the device so as to at least partially cover the first surface of the implant, When the implant fixation device is in the second wrapped configuration, tension is applied to the tether connected to the peripheral portion of the device so as to pull the peripheral portion radially inward, thereby partially enclosing the implant between the central portion and the peripheral portion. Methods that include...

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

29. The method according to claim 27, further comprising moving one or more tabs attached to the peripheral portion from a first orientation directed toward the central portion to a second orientation directed toward the outer portion of the central portion, and fixing one or more tabs to an implant site.

30. The method according to claim 29, further comprising implanting the implant fixation device and the implant assembly into the thoracic cavity through an incision site before fixing the one or more tabs to the implant site.

Images