Implant fixation device

Abstract

The utility model relates to an implant fixing device. Fixation devices for implants and related methods are generally described. The fixation device may be wrapped around the implant prior to delivery to reduce the risk of implant migration after implantation. The device may have porosity to induce tissue ingrowth around the implant and improve surgical outcome. The device can be used for rapidly preparing implants and can adapt to implants of various sizes. In some embodiments, the device may include a central portion for covering an anterior surface of a breast implant and a peripheral portion for covering a posterior surface of the implant. The peripheral portion, which may include a continuous rim or a plurality of legs, may include a tab that secures the fixation device to an implantation site. In some embodiments, a tether may be coupled to a distal end portion of the peripheral portion, thereby serving as a pull cord that quickly wraps the device around the implant.

Description

Technical Field

[0001] The present disclosure relates generally to the field of surgery and, more particularly, to implantable medical devices that limit migration of breast implants following breast-related surgeries such as breast reconstruction including augmentation mastopexy, breast augmentation, and breast revision. Background Art

[0002] Breast reconstruction after mastectomy has become an integral and important part of breast cancer treatment, where the procedure provides both aesthetic and psychosocial benefits to patients. In the United States, nearly 65% ​​of breast reconstruction surgeries currently use a tissue expander to create a pocket for a permanent breast implant in the first step of the procedure. In some patients, a pocket for a breast implant can be created without the use of a tissue expander. Once the pocket has been created, the tissue expander is removed and replaced with a permanent breast implant in a second step.

[0003] Breast implants can also be used in breast augmentation and mastopexy to increase breast size. In mastopexy, a breast lift is combined with a breast augmentation. Most commonly, the breast implant is placed in a pocket beneath the breast tissue, but in some cases, it is implanted beneath the chest wall. In some cases, breast implants are used in breast revision procedures, where an existing implant is replaced with a new one. A revision procedure may be performed if the existing implant was not positioned well during the initial placement and / or if any long-term complications occur after implantation.

[0004] Breast implants vary in size, shape, and surface texture. There are a variety of different sizes available, allowing surgeons and patients to choose from a range of projections, heights, widths, and overall volumes. In terms of shape, there are round and anatomically shaped implants, and the surface of the implant can be smooth, microtextured, or macrotextured. Generally speaking, round implants have a smooth surface, while anatomically shaped implants have a surface with a concave microtexture or macrotexture. Utility Model Content

[0005] In some embodiments, an implant fixation device is disclosed. An implant fixation device for fixing an implant in a patient may include: a central portion sized and shaped to at least partially cover a first surface of the implant; and a peripheral portion extending radially away from the central portion, wherein the peripheral portion includes at least one tab extending radially toward the central portion in a first orientation when the implant fixation device is in a first expanded configuration, and wherein the device is formed of a porous biocompatible material.

[0006] In other embodiments, an implant fixation device is disclosed. An implant fixation device for fixing an implant in a patient may include: a central portion sized and shaped to at least partially cover a first surface of an implant; a peripheral portion extending radially away from the central portion when the implant fixation device is in a first expanded configuration; and a tether coupled to the peripheral portion, the tether configured to be tensioned to pull the peripheral portion radially inwardly, thereby at least partially enclosing the implant between the central portion and the peripheral portion when the implant fixation device is in a second wrapped configuration, wherein the device is formed of a porous biocompatible material.

[0007] In other embodiments, methods of operating an implant fixation device are also disclosed. A method of operating an implant fixation device includes positioning a central portion of the device to at least partially cover a first surface of an implant, wrapping a peripheral portion of the device to at least partially cover a second surface of the implant, the peripheral portion extending radially away from the central portion, moving one or more tabs attached to the peripheral portion from a first orientation oriented toward the central portion to a second orientation oriented away from the central portion, and securing the one or more tabs to an implantation site.

[0008] In other embodiments, methods of operating an implant fixation device are also disclosed. A method of operating an implant fixation device includes positioning a central portion of the device to at least partially cover a first surface of an implant, and applying tension to a tether coupled to a peripheral portion of the device to pull the peripheral portion radially inward, thereby at least partially enclosing the implant between the central portion and the peripheral portion when the implant fixation device is in a second wrapped configuration.

[0009] It should be understood that the aforementioned concepts and the additional concepts discussed below can be arranged in any suitable combination, as the present disclosure is not limited in this respect. In addition, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component illustrated in various figures may be represented by the same reference numeral. For purposes of clarity, not every component is labeled in every drawing. In the drawings:

[0011] Figure 1 An exemplary breast implant is shown;

[0012] Figure 2 One embodiment of an implant fixation device is shown;

[0013] Figure 3Three embodiments of implant fixation devices for use with implants of different sizes are shown;

[0014] Figure 4 shows a rear side view of an implant fixation device applied to an implant according to one embodiment;

[0015] Figure 5 shows a front side view of an implant fixture applied to an implant according to one embodiment;

[0016] Figure 6 An embodiment of an implant fixation device applied to an implant is shown;

[0017] Figure 7 Two embodiments of implant fixation devices applied to different types of implants are shown;

[0018] Figure 8 Another embodiment of an implant fixation device is shown;

[0019] Fig. 9 shows a top view of an implant fixture according to one embodiment;

[0020] Fig.10 shows a rear side view of an implant fixation device applied to an implant according to one embodiment;

[0021] FIG. 11A to FIG. 11D Another embodiment of an implant fixation device is shown;

[0022] Fig.12 shows a top view of an implant fixture according to one embodiment;

[0023] FIG. 13A to FIG. 13D Another embodiment of an implant fixation device is shown;

[0024] Fig.14 An exploded view of yet another embodiment of an implant fixation device is shown;

[0025] FIG. 15A to FIG. 15B Shows Fig.14 an assembled view of an implant fixture; and

[0026] FIG. 16A to FIG. 16C Shows Figures 14 to 15B Various views of a breast implant in an implant fixation device. DETAILED DESCRIPTION

[0027] An increasing number of patients considering breast reconstruction and breast augmentation are reluctant to have permanent breast implants placed in their breasts. This is particularly true for women who have undergone a mastectomy and are currently considering breast reconstruction. Conventional breast implants formed from permanent, non-absorbable materials such as silicone gel pose a risk of complications when used alone, including potential capsular contracture, implant rupture or deflation, and the development of anaplastic large cell lymphoma (ALCL).

[0028] Additionally, conventional implants may not be secured in place after implantation due to the interaction between the permanent implant and the surrounding fascia, which increases the risk of migration or movement over time. For example, permanent breast implants may rotate after implantation, resulting in an unnatural appearance of the breast. In some cases, implants may migrate after implantation, resulting in asymmetry and disfigurement of the patient's anatomy. Many of these complications may require surgery to correct, which can be expensive and undesirable, in addition to the accumulation of scar tissue and delayed healing.

[0029] In some cases, implantation of the implant may also cause complications. For example, during the implantation process, the implant may come into contact with the incision site and the implant may be undesirably contaminated by blood or other viscera from the incision site. In some cases, contact of the implant with the incision site may result in improper healing of the incision or implant site, which may reduce blood flow to the site and cause tissue necrosis.

[0030] Recently, permanent breast implants have been covered with implant wraps prior to delivery to facilitate tissue ingrowth around the permanent implant, thereby reducing the likelihood of the above-mentioned complications. The inventors have recognized that existing wraps may require the surgeon to customize the shape and size of the permanent implant relative to the desired shape and size prior to implantation. Such customization may require a skilled surgeon to spend approximately one hour in the operating room, thereby extending the operation time and thus increasing costs and adverse consequences. In addition, the customization process may require tedious measuring and cutting of the wrap, which in turn requires extensive contact with the implant prior to delivery to the implantation site.

[0031] In addition, although the U.S. Food and Drug Administration (FDA) has not approved the use of acellular dermal matrix (ADM) materials for breast reconstruction, some surgeons may use a wrap composed of acellular dermal matrix (ADM) materials, which can be extracted from human tissue in the form of an allograft or can be extracted from animal tissue in the form of acellular xenografts. The inventors have recognized that such materials are non-absorbable, which may cause complications such as infection, necrosis, hematoma and / or seroma. The inventors also recognize that ADM materials are elastic and may cause breast implants to shift or become disoriented over time. In some cases, complications associated with ADM wraps may require subsequent surgery, such as implant revision.

[0032] In view of the above, the inventors have recognized the benefits associated with an implant fixture that can be quickly applied to an implant before delivery. The implant can greatly shorten the operating time to improve surgical efficiency. In addition, in some cases, the fixture can be operated in a manner that minimizes contact with the implant before implantation. The fixture can be made of a porous biocompatible material that is conducive to tissue ingrowth. Therefore, the device can be used as a template for natural cells, vascular systems, and fluids to penetrate and form natural tissue around the implant. The fixture can also be made of an absorbable material, thereby degrading over time due to natural tissue formation to replace the device. The absorbability of the fixture can reduce the possibility of foreign body reaction and rejection. However, examples in which different benefits are provided by the system and method disclosed herein are also possible.

[0033] In some embodiments, the implant fixture can be formed of a porous biocompatible material and can include: a central portion configured to cover at least a portion of a first surface of the implant; and a peripheral portion extending radially outward from the central portion, the peripheral portion configured to cover at least a portion of a second surface of the implant. In embodiments where the implant is a breast implant, the central portion can be arranged to cover a curved anterior surface or anterior surface of a conventional hemispherical breast implant, and the peripheral portion can be configured to cover a relatively flat posterior surface or posterior surface of the implant.

[0034] In some embodiments, the implant fixture disclosed herein can be arranged to move between a first deployment configuration and a second wrapping configuration, the first deployment configuration is used to allow the implant to be placed against the central part, and in the second wrapping configuration, the peripheral part is wrapped around the dorsal part of the implant. In some embodiments, this conversion can be realized by means of a tether connected to the peripheral part. By applying tension to the tether through one or more handheld parts, the tether can tighten or gather the peripheral part around the implant and form a wrapping configuration, in which the implant fixture extends at least partially around the associated implant, and in some cases completely around the associated implant. The function of the tether is similar to a pulling rope, which is used to wrap the fixture conformally against the implant. This conversion can be carried out when the surgeon is in the least contact with the implant, thereby reducing the risk of contamination. Compared with the conventional technology of manually cutting and arranging the implant wrapping, the surgeon can complete the conversion between the fixture configurations faster, thereby improving the efficiency of the operation.

[0035] In some embodiments, the peripheral portion extending outward from the central portion of the implant fixture can include one or more tabs, and the one or more tabs can be fixed to the implantation site (for example, the pectoralis muscle or chest wall of the patient) during implantation to help fix the orientation and position of the implant and fixture assembly to the patient's anatomical structure. Tabs can be formed radially on the peripheral portion, and can be in the neutral non-biased configuration when the device is in the expanded configuration and the tab is in the neutral non-biased configuration, along the peripheral portion of the portion for locating the tab inwardly oriented toward the central portion of the device. During use, the tab can be configured to redirect to point outward away from the central portion when the device is converted to its wrapping configuration. Although it is also envisioned that the surgeon or other users manually redirect these tabs, this redirection of the tab can occur due to the conversion of the peripheral portion, without the need to represent the surgeon to pay any additional effort. When the device is in the wrapping configuration around the implant, the tab can extend away from the implant and the device assembly, thereby allowing the surgeon to easily identify these tabs (for example, by visual inspection or palpation), and the assembly is fixed to the patient's anatomical structure.

[0036] It should be understood that in some embodiments, the tabs may be oriented inwardly toward the central portion of the device when the device is in the expanded configuration. In other embodiments, the tabs may be oriented outwardly away from the central portion of the device when the device is in the expanded configuration. In other embodiments, the tabs may also be oriented at an angle relative to the radial direction of the peripheral portion. In other embodiments, a combination of inwardly oriented tabs, outwardly oriented tabs, and angled tabs may also be employed.

[0037] In some embodiments, the tab can be formed from the body of the peripheral portion. For example, the tab can be cut from the peripheral portion so that a portion of the tab can move freely relative to the peripheral portion and can be reoriented when the device is reconfigured between the expanded configuration and the wrapped configuration. In some embodiments, the tab can be an additional material portion attached to the peripheral portion by a suitable bonding technique, as will be described in more detail below.

[0038] 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-shaped to reduce preparation time, thereby eliminating the need for the surgeon to manually cut or modify the prosthetic fabric. During the wrapping process, the legs may be folded onto the body of the implant to fit the implant. In the embodiment where the fixture includes a tab, each tab may be formed along a respective leg. In the embodiment where the fixture includes a tether, the tether may be coupled to the distal end 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 provide sufficient coverage and support to the implant while reducing the possibility of warping and wrinkling on the implant. As will be described in more detail below, the arrangement of the legs and the central portion may allow the fixture to adapt to a variety of implant sizes and shapes in a rapid manner without the need for the surgeon to over-customize. Therefore, the surgeon can select from a group of fixture sizes (e.g., small, medium, large, extra large), and each size in this group of fixture sizes can adapt to a certain range of implant shapes and sizes. In some embodiments, this group of devices can adapt to at least 90% of obtainable conventional permanent implant sizes. In other embodiments, this group of devices can adapt to at least 80% of obtainable conventional permanent implant sizes.

[0039] In some embodiments, the peripheral portion of the implant fixture can be formed into the shape of a continuous edge, which extends outward from the central portion of the device and which at least partially, and in some cases completely, extends around the periphery of the central portion of the device. The function of the peripheral edge is similar to the legs, that is, the peripheral edge can wrap around at least a portion of the implant to facilitate natural tissue ingrowth. In some embodiments, a tether can be connected to the distal end portion of the peripheral edge, and can be tightened to help the device to convert from an expanded configuration to a wrapped configuration, thereby fitting with the implant.

[0040] As will be described in more detail below, in some embodiments, the maximum diameter of the central portion can be smaller than the base diameter of the associated breast implant, so that wrapping the central portion around the implant can reduce the likelihood of wrinkling or warping of the fixation device for a more desirable aesthetic effect.

[0041] In some embodiments, the implant fixture comprising a central portion and a peripheral portion can be arranged to be in the form of a roughly two-dimensional patch body when in an expanded configuration. For example, in some embodiments, when the implant fixture is arranged to be in an expanded configuration on a flat support surface, the central portion and the peripheral portion can be laid flat in a plane. When the peripheral portion (for example, the outer edge or one or more legs) is converted to a wrapping configuration from the expanded configuration around the implant, the device can be arranged to be in a three-dimensional configuration that extends conformally around at least a portion of the implant.

[0042] In some embodiments, the central portion of the fixture can be provided in a generally three-dimensional form. For example, the central portion can be pre-shaped to mimic the curvature of a breast implant (and / or any other suitable implant), and can be shaped and sized to receive the implant in the central portion. In some embodiments, the central portion can have a hemispherical shape. The curved central portion can allow the fixture to conform to the breast implant to reduce the possibility of wrinkling and warping.

[0043] In some embodiments, the fixture of the present disclosure can be formed of a biocompatible prosthetic repair fabric such as a porous mesh material. The pores of the mesh can induce tissue infiltration and growth of natural tissue around the implant. In some embodiments, the fixture can be formed of a bioabsorbable material that can degrade while natural tissue grows throughout the pores. In this way, the fixture can be slowly replaced by natural tissue. In other embodiments, the fixture can be formed of a permanent material and can exhibit porosity and / or texture to induce tissue growth on its surface.

[0044] In some embodiments, various features of the fixture (e.g., central portion, tabs, legs) can be formed from the repair fabric sheet by any suitable means, including but not limited to die cutting, laser cutting, water jetting, hand cutting, and / or any other suitable forming technique. In embodiments where portions of the fixture are preformed into a three-dimensional shape, the repair fabric sheet can be formed using thermoforming or compression molding techniques, as described in detail below.

[0045] The disclosed fixture can be used for a variety of different applications and can provide many different benefits. In some embodiments, the fixture can be formed of a porous material to serve as a scaffold for tissue infiltration, in which case the tissue can grow into the device. Natural tissue can serve as a natural shell around the implant and reduce the risk of capsular contracture and potential rejection of foreign implants. In this way, the risk of complications can be reduced and the surgical effect can be improved. Since the natural tissue formed by the pores of the device can grow and / or be fixed to the natural anatomical space from the natural anatomical space, the ingrowth of the tissue can have the additional benefit of anti-migration. The formation of natural tissue formed at the implant site can also reduce the risk of foreign body reaction complications, such as capsular contracture. In some embodiments, the fixture can be wrapped around the implant and attached to the surgical site in a manner that reduces the contact between the implant and the incision site, through which the implant and the device assembly are delivered. For example, the fixture can protect the implant from the influence of viscera or fluid at the incision site to reduce the risk of necrosis and contamination. In some embodiments, the fixture of the present disclosure can be configured to wrap around the implant quickly to reduce the preparation and customization time during surgery. Therefore, the surgeon can quickly wrap the fixture around various types and shapes of implants and ensure a conformal package with reduced wrinkling and warping possibilities. In some embodiments, the fixture can be selectively converted between the deployment configuration and the wrapping configuration with limited contact between the surgeon and the implant. In this way, the possibility of contamination and infection can be reduced. However, examples in which different benefits are provided by the system and method disclosed herein are also possible.

[0046] The fixation device of the present disclosure can be composed of a biocompatible material that can promote rapid ingrowth of tissue or muscle into and around the device. In some embodiments, the fixation device can be formed of an absorbable material that can be replaced by the patient's natural tissue in vivo as the device degrades.

[0047] In some embodiments, the device can be formed of an absorbable material (e.g., a polymer or copolymer) that can be substantially absorbed within a time range of 1 month to 24 months, a time range of 3 months to 18 months, and / or any other suitable time range after implantation. In some embodiments, the device can maintain some residual strength within a time range of at least 2 weeks to 6 months, at least 12 weeks to 6 months, and / or any other suitable time range. It should be understood that the fixation devices of the present disclosure can maintain residual strength within any suitable time range depending on the operation and implantation site.

[0048] In some embodiments, the fixation device may include an absorbable polymer comprising or prepared from one or more monomers selected from the following group: 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-propylene glycol, ethylene glycol, glutaric acid, malic acid, malonic acid, oxalic acid, succinic acid, and adipic acid.

[0049] In some embodiments, the fixture may be formed of poly-4-hydroxybutyrate (P4HB) and copolymers thereof, or poly(butylene succinate) (PBS) and copolymers thereof. In embodiments, P4HB and PBS polymers and copolymers thereof may not be cross-linked. In embodiments, PBS polymers and copolymers may also include one or more of the following: a branching agent, a cross-linking agent, a chain extender, and a reactive blending agent. PBS and P4HB polymers and copolymers may be isotopically enriched in some embodiments.

[0050] Fixtures of the present disclosure can be formed by repair fabric materials in the form of mesh, woven material, nonwoven material, knitted material, braided material, felt fabric, combinations thereof and / or any other suitable type of repair fabric. In some embodiments, the repair fabric material can be porous to allow natural biological materials (such as fluids, cells, vascular systems) to infiltrate the fixture. The repair fabric material can be formed by non-limiting example materials, such as the PHASIX mesh that can be obtained from Davol, the GalaFLEX or GalaFLEX LITE that can be obtained from Galatea, the TIGR Matrix that can be obtained from Novus Scientific, the SERI Surgical Body that can be obtained from Allergen, the BIO-A that can be obtained from Gore, and the ULTRAPRO that can be obtained from Ethicon. If desired, nonwoven materials can be used as a substitute or together with mesh to provide a relatively soft contour for the prosthesis.

[0051] In some embodiments, the polymer used to prepare the immobilization device can have a weight average molecular weight relative to polystyrene determined by GPC of 50 kDa to 1,000 kDa, 90 kDa to 600 kDa, and / or from 200 kDa to 450 kDa, although other weight average molecular weight polymers are contemplated.

[0052] In some embodiments, the device can be formed of permanent materials, such as non-biodegradable thermoplastic polymers, including polymers and copolymers of ethylene and propylene, including ultra-high molecular weight polyethylene, ultra-high molecular weight polypropylene, nylon, polyesters such as poly(ethylene terephthalate), poly(tetrafluoroethylene), polyurethane, poly(ether-urethane), poly(methyl methacrylate), polyetheretherketone, polyolefins, and poly(ethylene oxide). In other embodiments, the device can be formed of degradable materials, including but not limited to thermoplastic or polymer degradable materials. Combinations of the foregoing are contemplated. In some embodiments, the device can be formed of one or more absorbable polymers or copolymers, absorbable thermoplastic polymers and copolymers, and / or absorbable thermoplastic polyesters. The device can be formed from polymers including, but not limited to, glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyrate, ε-caprolactone, including polyglycolic acid, polylactic acid, polydioxanone, polycaprolactone, copolymers of glycolic acid and lactic acid, such as polymer, and Polymers, and include poly(lactide-co-caprolactone); poly(orthoesters); polyanhydrides; poly(phosphazenes); polyhydroxyalkanoates; synthetically or biologically prepared polyesters; polycarbonates; tyrosine polycarbonate; polyamides (including synthetic and natural polyamides, polypeptides and poly(amino acids)); polyesteramides; poly(alkylene alkylates); polyethers (such as polyethylene glycol PEG and polyethylene oxide PEO); polyvinyl pyrrolidone or PVP; polyurethanes; polyetheresters; polyacetals; polycyanoacrylates; poly(oxyethylene) / poly(oxypropylene) copolymers; polyacetals, polyketals; polyphosphates (polyph osphate); (phosphorus-containing) polymers; polyphosphoesters; polyalkylene oxalates; polyalkylene succinates; poly(maleic acid); silk (including recombinant silk and silk derivatives and analogs); chitin; chitosan; modified chitosan; biocompatible polysaccharides; hydrophilic or water-soluble polymers, such as polyethylene glycol (PEG) or polyvinyl pyrrolidone (PVP), and blocks of other biocompatible or biodegradable polymers, such as poly(lactide), poly(lactide-co-glycolide) or polycaprolactone and copolymers thereof, including random copolymers and block copolymers thereof.

[0053] In some embodiments, fixture can be loaded, filled and / or coated with suitable therapeutic composition.This can include coating, absorbent material, adsorbent material, the compound of material functional combination with fixture and / or any other suitable mode that therapeutic composition is associated with fixture.The therapeutic composition of suitable type can include but not limited to cell, stem cell, differentiated cell, adipocyte, muscle cell, platelet, pedicle, vascular pedicle, tissue mass, extracellular adipose matrix protein, gel, hydrogel, hyaluronic acid, collagen, bioactive agent, medicine, antibiotic and can expect to be delivered to other suitable therapeutic compositions of implantation site.The cell and tissue that can be delivered and / or coated or injected into the device can be autologous.Device can be used for autologous fat transfer.Add, be coated or be injected into the cell on the device can include islet cell, hepatocyte and through gene change to comprise the stem cell of the gene for treating patient's disease. The device may include bioactive agents to stimulate cell ingrowth, including growth factors, cell adhesion factors, cell differentiation factors, cell recruitment factors, cell receptors, cell binding factors, cell signaling molecules such as cytokines, and molecules to promote cell migration, cell division, cell proliferation, and extracellular matrix deposition. The device may also be partially or completely coated and / or contain an agent to prevent tissue adhesion or to prevent cell proliferation, particularly to delay cell invasion into the device.

[0054] In some embodiments, the fixture can be partially or completely loaded, filled, coated or otherwise combined with a bioactive agent. The bioactive agent can be included in the device for a variety of reasons. For example, a bioactive agent can be included to improve tissue ingrowth into the implant, improve tissue maturation, provide the delivery of an active agent, improve the wettability of the implant, reduce the risk of infection and improve cell attachment. The bioactive agent can also be incorporated into the material composition of the substrate of the subunit.

[0055] Device can comprise the active agent designed to stimulate cell ingrowth, active agent comprises growth factor, cell adhesion factor including cell adhesion polypeptide, cell differentiation factor, cell recruitment factor, cell receptor, cell binding factor, cell signaling molecule such as cytokine and molecule for promoting cell migration, cell division, cell proliferation and extracellular matrix deposition.Such active agent comprises 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 nerve growth factor (NGF) and combination thereof.As used herein, term " cell adhesion polypeptide " refers to compound with at least two amino acids per molecule, which can bind cell via cell surface molecule. Cell adhesion polypeptides include any protein in the extracellular matrix known to play a role in cell adhesion, including fibronectin, vitronectin, laminin, elastin, fibrinogen, collagen type I, collagen type II and collagen type V, and synthetic peptides with similar cell adhesion properties. Cell adhesion polypeptides also include peptides derived from any of the aforementioned proteins, including fragments or sequences containing binding domains.

[0056] In some embodiments, the fixation device can be loaded, filled, coated or otherwise combined with a wetting agent designed to improve the wettability of various surfaces of the device to allow fluids to easily adsorb onto the device surface and promote cell attachment and / or modify the water contact angle of the device surface. Examples of wetting agents include polymers of ethylene oxide and propylene oxide such as polyethylene oxide, polypropylene oxide, or copolymers of ethylene oxide and propylene oxide such as Other suitable wetting agents may include surfactants or emulsifiers.

[0057] In some embodiments, the fixture can be loaded, filled, coated or otherwise combined with a gel, hydrogel or active hydrogel mixture to further improve the wetting properties and promote cell growth throughout the device. The hydrogel mixture can be composed of living cells encapsulated in a biocompatible hydrogel such as gelatin, methacrylated gelatin (GelMa), silk gel and hyaluronic acid (HA) gel.

[0058] Other bioactive agents that can be incorporated into the device can include antimicrobial agents, particularly antibiotics, disinfectants, tumor agents, anti-scarring agents, anti-inflammatory agents, anesthetics, small molecule drugs, anti-adhesive agents, cell proliferation inhibitors, anti-angiogenic factors and pro-angiogenic factors, immunomodulators and coagulants. Bioactive agents can be proteins such as collagen and antibodies, peptides, polysaccharides such as chitosan, alginate, hyaluronic acid and derivatives thereof, nucleic acid molecules, small molecular weight compounds such as steroids, inorganic materials such as hydroxyapatite and ceramics, or complex mixtures such as platelet-rich plasma. Suitable antimicrobial agents include: bacitracin, biguanide, triclosan, gentamicin, minocycline, rifampicin, vancomycin, cephalosporin, copper, zinc, silver and gold. Nucleic acid molecules can include DNA, RNA, siRNA, miRNA, antisense molecules or aptamers.

[0059] In some embodiments, the fixation device can be loaded, filled, coated or otherwise combined with allograft materials and xenograft materials, including acellular dermal matrix materials and small intestinal submucosa (SIS). In some embodiments, the device can be combined with a system for controlled release of a therapeutic or prophylactic agent.

[0060] In some embodiments, the fixture can be loaded, filled, coated or otherwise combined with allograft or xenograft tissue and cells before implantation, during implantation or after implantation or in any combination thereof. In some embodiments, the device can be coated with autologous tissue and cells from the patient before implantation, during implantation or after implantation or in any combination thereof. Autologous tissue and cells can include one or more of the following: autologous fat, lipoaspirate, adipose tissue, injectable fat, adipose tissue, adipose cells, fibroblasts and stem cells, stem cells include human adipose tissue derived stem cells, also referred to as precursor adipose cells or adipose tissue derived precursor cells and fibroblast-like stem cells. In one embodiment, the device can be coated with autologous tissue and cells as described herein, and can also further include vascular pedicles or other tissue blocks.

[0061] In some embodiments, the polymer and copolymer compositions of the device can have a low moisture content to ensure that the device can be produced with stiffness comparable to natural tissue, extended strength retention, and good shelf life. In some embodiments, the polymers and copolymers used to prepare the device have a moisture content of less than 1,000 ppm (0.1 wt%), less than 500 ppm (0.05 wt%), less than 300 ppm (0.03 wt%), less than 100 ppm (0.01 wt%), and / or less than 50 ppm (0.005 wt%).

[0062] It should be understood that the composition for preparing the device can have a low endotoxin content. In some embodiments, the endotoxin content can be low enough so that the device produced by the polymer composition has an endotoxin content of less than 20 endotoxin units per device as determined by a Limulus amebocyte lysate (LAL) assay. For example, the endotoxin content of the polymer composition for preparing the device can be less than 2.5EU / g polymer or copolymer. In another example, the endotoxin content of a P4HB polymer or copolymer or a PBS polymer or copolymer is less than 2.5EU / g polymer or copolymer.

[0063] In some embodiments, the device of the present disclosure may include one or more markers for external detection of the device position. For example, the device may include a radiopaque marker (e.g., a metal tag, a radiopaque material) that can be visible and obvious on nearby anatomical structures during x-ray imaging. The marker can be formed by any suitable medical material that can be used for medical imaging and is approved for long-term use. Medical imaging can be performed using, for example, radiographic imaging modes (e.g., x-ray imaging), magnetic resonance imaging (MRI), ultrasonography, fluoroscopy, or computed tomography. The marker can therefore be formed by any non-absorbable biocompatible material, which can refer to a material that does not cause any adverse reactions to the patient's health and does not decompose within the patient's lifetime. Non-absorbable biocompatible materials may include, but are not limited to, metal-containing materials, polymeric materials, ceramic materials, or composite materials including metals, polymers, or combinations of metals and polymers. Suitable metals may include, but are not limited to, gold, iridium, nickel, rhodium, silver, tantalum, titanium, stainless steel, and alloys thereof, combinations thereof, and / or other metals. Suitable polymers include, but are not limited to, polyvinyl alcohol, polyurethane, polyolefins, polyesters, polypropylene, polyimides, polyetherimides, fluoropolymers, thermoplastic liquid polymers (LCPs) such as Celanese Polyvinyl ether ketone, such as PEEK from Vitrex TM , polyamide, polycarbonate, such as Bayer Polymers Polysulfone, polyethersulfone, polyphenylsulfone, such as Rowland Technologies Nylon, nylon copolymers, combinations thereof, and / or other polymers. In some embodiments, a marker can include a shape memory material including, but not limited to, nitinol, titanium, or any shape memory polymer.

[0064] As previously mentioned, in some embodiments, the soft tissue fixation device can be used together with an implant (e.g., permanent or degradable breast implant) in soft tissue regeneration, augmentation, repair, enhancement, replacement and / or reconstruction surgery. In the case of breast surgery, the fixation device can be used in combination with the implant used in mastectomy, mastopexy, lumpectomy and breast augmentation surgery. The device can be biocompatible and in some cases absorbable so that the device can be replaced by the patient's tissue in vivo as the device degrades. In some embodiments, the device can be coated or filled with material to induce tissue ingrowth and / or reduce the risk of infection. For example, the device can be coated or filled with autologous tissue, autologous fat, lipoaspirate, injectable fat, adipose cells, fibroblasts and stem cells before, during or after implantation.

[0065] The fixation device of the present disclosure can be used in any suitable application. In some embodiments, the prosthesis can be used together with an implant (e.g., a soft or hard tissue implant) after an operation during the treatment of cancer 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 in soft tissue reconstruction applications such that the device can be wrapped around, partially enclosed, or completely surrounded by: breast implants, breast lift implants, tissue expanders, breast enlargement implants, nipple implants, facial reconstruction implants, buttock implants, zygomatic augmentation devices, cosmetic repair implants, soft tissue regeneration implants, hernia implants, hernia plugs, wound healing implants, tissue engineering scaffolds, scaffolds for vascular pedicles or other tissue masses, guided tissue repair / regeneration devices, expansion or filling implants, void fillers, implants for treating vesicoureteral 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, neurostimulators, vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, combinations thereof, and / or any other suitable applications. In embodiments, the implant has a shape and size suitable for use in breast surgery including breast augmentation, breast reconstruction, and mastopexy.

[0066] As generally used herein, "absorbable" means that the material degrades in the body and the degradation products are eliminated or excreted from the body. The terms "absorbable," "resorbable," "degradable," and "erodible" - with or without the prefix "bio" - may be used interchangeably herein to describe a material that is broken down and gradually absorbed, excreted, or eliminated by the body, whether the degradation is primarily due to hydrolysis or mediated by metabolic processes.

[0067] As generally used herein, "biologically active agent" refers to a therapeutic agent, a prophylactic agent or a diagnostic agent, an agent that promotes healing and regeneration of host tissue, and also a therapeutic agent that reduces the risk of infection. "Agent" includes such an agent alone, and is also intended to include multiple agents.

[0068] As generally used herein, "biocompatibility" means that the biological response to a material or device is appropriate for the intended in vivo application of the device. Any metabolites of these materials should also be biocompatible.

[0069] "Blend" as generally used herein means a physical combination of different polymers, other than a copolymer formed from two or more different monomers.

[0070] "Breast implant" as generally used herein means any implant, whether permanent, non-permanent (eg, degradable), or a combination thereof, used in breast reconstruction surgery.

[0071] As generally used herein, "copolymer of poly-4-hydroxybutyrate" means any polymer comprising 4-hydroxybutyrate with one or more different hydroxy acid units. The copolymer may be isotopically enriched.

[0072] As generally used herein, "copolymer of poly(butylene succinate)" means any polymer comprising 1,4-butanediol and succinic acid units and one or more different diol or diacid units. The copolymer may comprise one or more of the following: a branching agent, a crosslinking agent, a chain extender, and a reactive blending agent. The copolymer may be isotopically enriched.

[0073] "Endotoxin content" as generally used herein refers to the amount of endotoxin present in an implant or sample and is determined by the Limulus Amebocyte Lysate (LAL) assay.

[0074] As generally used herein, "poly-4-hydroxybutyrate" means a homopolymer containing 4-hydroxybutyrate units. Poly-4-hydroxybutyrate may be referred to herein as P4HB or Biomaterial (manufactured by Tepha, Inc., Lexington, Mass.) The polymer may be isotopically enriched.

[0075] As used herein, "tether" may mean any generally flexible one-dimensional structure formed by one or more yarns, fibers, ropes, bands, strands, lines, sutures, monofilaments and / or multifilaments. Such structures may include knitted fabrics, braided fabrics, woven materials, nonwoven materials, combinations thereof and / or any other suitable form factors. Rope materials of the present disclosure may be made of any suitable biocompatible material or combination of materials, bioabsorbable and / or non-bioabsorbable materials.

[0076] Turning to the drawings, specific non-limiting embodiments are further described in detail. It should be understood that the various systems, components, features, and methods described with respect to these embodiments may be used alone and / or in any desired combination, as the present disclosure is not limited to the specific embodiments described herein.

[0077] Figure 1 An exemplary permanent implant 10 that can be used in conjunction with the fixation device of the present disclosure is shown. The implant 10 can be formed of a non-absorbable material, such as silicone. Figure 1 As shown in, in an embodiment where the implant is a breast implant, the implant can be shaped in a generally hemispherical manner, with a maximum base diameter D1 or a similar maximum transverse dimension and an effective profile height H1. The base diameter can have any suitable size according to the patient's natural anatomical structure and the desired implant shape. For example, the maximum base diameter D1 can include, but is not limited to, greater than or equal to about 6cm, 8cm, 10cm, 12cm, 15cm, 18cm, 20cm, 22cm, and / or less than or equal to about 22cm, 20cm, 18cm, 15cm, 12cm, 10cm, 8cm, 6cm, and / or any other suitable maximum diameter. Combinations of the above ranges are contemplated, including maximum base diameters between about 6cm and 22cm, between 8cm and 18cm, and / or ranges greater than and less than the above ranges. Similarly, the profile height of the implant can be any suitable diameter to accommodate the patient's anatomical structure and the desired implant shape. Exemplary profile heights H1 include, but are not limited to, between 2 cm and 15 cm, between 3 cm and 10 cm, between 4 cm and 7 cm, combinations thereof, and / or any other suitable dimensions.

[0078] In some embodiments, the size of the implant can be determined in terms of volume. Thus, the fixation device of the present disclosure can be compatible with any suitable conventional implant size, including but not limited to greater than, less than or equal to 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, 700cc, 710cc, 720cc, 730cc, 740cc, 750cc, 760cc, 770cc, 780cc, 790cc, 800cc and / or any other suitable implant size.

[0079] Figure 2 A fixture 100 in a two-dimensional configuration of deployment according to some embodiments is shown. The fixture 100 may include a peripheral portion at which one or more legs 110 radially extend away from a central portion 111. In some cases, a plurality of legs extending outward from the central portion may be distributed around the periphery of the central portion. As will be described in more detail below, the legs 110 may be sized to enclose a portion of an implant (e.g., a breast implant) to help secure the implant to the patient's anatomical structure. The central portion 111 may be sized to cover a portion of an implant (e.g., a portion of a curved surface of a breast implant).

[0080] In some embodiments, the central portion 111 can have a maximum diameter D2 or other suitable maximum transverse dimension that can be smaller than the maximum diameter D1 of the implant, such as Figure 2. This difference in diameter forms a spacing 112 between the legs 110, which can allow the legs to be wrapped around the implant with minimal risk of wrinkling or warping. In some embodiments, the presence of the spacing 112 between the legs 110 can also enable the device 100 to be wrapped around a variety of implants of different sizes. Therefore, the ratio between the maximum diameter D2 of the central portion and the diameter D1 of the implant can be any suitable ratio less than or equal to 1. In some embodiments, the central portion of the implant fixture can be roughly aligned with the central portion of the adjacent surface of the implant.

[0081] like Figure 2 As shown in , the peripheral legs 110 can extend radially away from the central portion 111. It should be understood that although six legs are shown, each extending an equal distance away from the central portion, embodiments in which the legs are asymmetrically distributed around the central portion, as well as embodiments having more or less than six legs, are also contemplated. For example, the implant fixation device includes 3 legs. When in the expanded, flat configuration, the legs can be bounded by an imaginary circle having a diameter D3, which can be referred to as the diameter or maximum lateral dimension of the device, 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., a circular surface of a breast implant) to a second surface (e.g., a flat surface of a breast implant) to partially or completely wrap around or surround the implant. Thus, the maximum diameter D3 of the device can be greater than the maximum diameter D1 of the implant, as shown in the figure. Figure 2 Diameter D3 may also be small enough to reduce the risk of substantial material overlap during wrapping of the implant.

[0082] In some embodiments, the maximum diameter D3 of the device can be selected according to the implant diameter, as described above, the implant diameter can be different according to the patient's needs. The maximum diameter D3 of the device can be any suitable size to adapt to the implant diameter, including but not limited to greater than or equal to about 110%, 120%, 130%, 150%, 180%, 200%, 220%, 250%, 280%, 300% and combinations thereof of the implant diameter D1, and / or less than or equal to about 300%, 280%, 250%, 220%, 200%, 180%, 150%, 130%, 120%, 110% and combinations thereof, and / or any other percentage of the implant diameter D1.

[0083] In some embodiments, each leg 110 may include at least one tab 115 positioned between the central portion 111 and a distal end portion of the leg where the at least one tab is disposed. Figure 2. In some embodiments, multiple tabs can be associated with multiple legs. For example, each leg can include one or more tabs that are attached to the associated leg using any suitable attachment and / or are integrally formed with the leg. Tabs 115 can allow the device to be secured to the patient's anatomy to help hold the device in place relative to the anatomy. In the case of breast reconstruction surgery, the device can be secured to the patient's pectoral wall.

[0084] In the deployed configuration of the device 100, each tab can be arranged in or parallel to the two-dimensional plane of the corresponding leg. The tabs 115 can be coupled to the legs in a manner that allows each tab to deform in a direction oriented away from the plane of the leg. For example, Figure 2 As shown in , the tab can be formed along the body of the leg using an incision to form a tab attached to the leg that includes a distal portion relative to the central portion of the device in the expanded configuration. In some embodiments, the tab can be formed separately from the leg (e.g., formed with a separate prosthetic mesh material), and the tab can be attached to the leg at the distal portion of the tab. As will be described in more detail below, when the device is wrapped around the implant, the tab can move between a first orientation oriented toward the central portion 111 in the expanded configuration and a second orientation oriented away from the central portion.

[0085] As described above, in some embodiments, the tab 115 can be formed directly along the leg 110. For example, the tab 115 can be cut from the leg by any suitable technique, including but not limited to shearing or cutting with scissors, a blade, other sharp cutting tool or hot knife, laser cutting technology, die cutting technology, water jet, hand cutting, combinations thereof, and / or any other suitable technique. In other embodiments, the tab can be formed separately and connected to the leg by any suitable method, including but not limited to heat sealing, welding (e.g., ultrasonic or other welding), bonding, sewing, combinations thereof, and / or any other suitable technique.

[0086] It should be understood that regardless of the type of formation of the tabs, the tabs can be arranged to have a proximal portion of the tab oriented toward the central portion of the device in the expanded configuration, which proximal portion is free to move and can therefore be reoriented when the device is wrapped around the implant. Figure 2 As shown in , when the device is in the expanded configuration, the tabs can be directed toward the central portion in its first orientation. As will be described in more detail below, when the device is positioned around the implant in the wrapped configuration, the tabs can extend outward from the device, thereby pointing away from the central portion. The surgeon can then use these outwardly directed tabs to fix the device to the patient's anatomical structure.

[0087] It should be understood that the tabs may be arranged at any position along their respective legs. Figure 2 As shown in , the tab can be roughly arranged in the middle of the leg extending between the central part 111 of the device and the distal end of the leg. In other embodiments, the tab can be arranged to be closer to the distal end portion of the leg than near the central part. In some other embodiments, the tab can be arranged to be closer to the central part than near the distal end portion of the leg. It should be understood that the position of the tab relative to the leg can be conducive to the packaging of one or more implant sizes. Therefore, the present disclosure is not limited by the arrangement of the tab on the leg.

[0088] The tabs may have any suitable dimensions relative to their respective legs. In embodiments where the tabs are formed from the body of the leg, the tabs may have a width that is less than the width of the body of the leg. In embodiments where the tabs are formed from a material coupled to the body of the leg, the width of the tabs may be approximately equal to the width of the leg, and / or may be less than the width of the leg. It should be understood that the present disclosure is not limited by the shape or size of the tabs.

[0089] Figure 2 Each leg 110 is shown with 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 depend on how the surgeon plans to secure the device to the patient's anatomy. Thus, the device may include any suitable number of tabs that is equal to and / or less than the number of legs. In addition, it is also contemplated to include multiple tabs on a single leg.

[0090] It should be understood that although Figure 2 Six symmetrical legs are shown in the figure, but embodiments with more than six legs and embodiments with less than six legs are contemplated. In some embodiments, the legs can be distributed asymmetrically around the central portion. For example, the device can have more legs on the portion of the device corresponding to the lower pole of the breast implant to provide more structural support in response to gravity. It should also be understood that although Figure 2 The legs in are shown as being substantially similar in size and shape, but embodiments having legs of different sizes / shapes are contemplated as the disclosure is not limited by the number, size, shape and / or arrangement of the legs relative to the central portion.

[0091] In some embodiments, the device 100 may include a tether 120 coupled to the distal end of one or more legs 110, such as Figure 2. The tether 120 can allow the surgeon to convert the device from its expanded configuration to its wrapped configuration without having to manually fold or arrange each leg around the implant. The tether can act as a drawstring, allowing the surgeon to quickly wrap the device around the implant by applying tension to the tether 120. In some embodiments, the tether can include a hand-held portion 125 that allows the tether to be tensioned and the device wrapped around the patient. The tether 120 can be coupled to the leg 110 in one or more regions 122. The coupling can allow the tether to be able to move axially relative to the leg to allow the tether to be tensioned but not secured to the leg. For example, the tether can pass through one or more pores of a porous material of the leg 110. As Figure 2 As shown in , in some embodiments, at least one end of the tether 120 may include a needle 128 to facilitate weaving or coupling the tether 120 to the leg. Alternatively, other methods of attaching the tether to the leg in a slidable manner may be used, as the present disclosure is not limited in this manner.

[0092] It should be understood that the tether can be formed of a flexible material so as to be woven through or otherwise coupled to the legs, but the tether can be sufficiently inelastic to reduce the likelihood of excessive axial extension preventing proper wrapping of the device. In some embodiments, the tether 120 can be formed of polypropylene suture.

[0093] Although tether 120 is shown as being woven through the distal portion of leg 110, it should be understood that the tether may be coupled to any portion or combination of portions of any of the legs of the present disclosure to enable encapsulation of the implant when the tether is tightened.

[0094] Figure 3 Three sizes of fixtures formed of porous biocompatible materials and exemplary permanent implants are shown. Fixture 100A represents a small device to accommodate a small permanent implant 10A, fixture 100B represents a medium device to accommodate a medium permanent implant 10B, and fixture 100C represents a large device to accommodate a large permanent implant 10C. Figure 3As shown in , in some embodiments, the device may include tabs 115C arranged along the legs of the device to facilitate fixing the device to the patient's anatomy. If the implant has a maximum base diameter of about 9cm to 12cm and a profile height of about 3.5cm to 5cm, the implant can be characterized as "small", if the implant has a maximum base diameter of about 11cm to 14cm and a profile height of about 4.5cm to 6cm, the implant can be characterized as "medium", if the implant has a maximum base diameter of about 12cm to 15.5cm and a profile height of about 5cm to 7cm, the implant can be characterized as "large", and if the implant has a maximum base diameter of about 13cm to 17cm and a profile height of about 3cm to 7cm, the implant can be characterized as "extra large". It should be understood that the classification of implant sizes is exemplary and the fixation device described herein can be used for breast implants of any size.

[0095] Figure 3 The fixation device 100C is shown in an expanded configuration, wherein each leg radiates away from the central portion (obscured by the implant 10C). As shown, the tabs 115C are oriented so that the proximal portion of the tab is directed toward the central portion relative to the distal end portion of the associated leg when the device 100C is in the expanded configuration.

[0096] Figure 4 A rear view of an implant fixation device 100 in a wrapped configuration folded over an implant 10 is shown. To achieve this configuration, the legs 110 of the device 100 can be brought together on opposite sides of the implant by tensioning the tethers 120, as previously described. Tensioning the tethers on opposite sides of the implant can act as a drawstring to bring the legs together and wrap the device around the implant. In some embodiments, the tethers 120 can be used to sew the distal ends of the legs together prior to delivery. In some embodiments, the tethers 120 can be knotted to maintain the tensioned configuration of the tethers and the wrapped configuration of the legs. Due to the changes in the configuration and arrangement of the legs 110 of the device, the free ends of the tabs 115 can now be oriented so that the tabs are away (in Figure 4 The central portion of the implant 10 (obscured by the implant 10) is directed toward the surgeon. The surgeon can secure the implant and device assembly to the patient's anatomy via one or more tabs 115 after delivery.

[0097] It should be appreciated that in some embodiments, the implant 10 can be delivered to an implantation site (e.g., within the chest cavity) that is at least partially encapsulated in the device 100. In this manner, the device can protect or otherwise shield the implant from contact with the incision site and / or excessive contact with the surgeon to minimize the risk of undesirable contamination.

[0098] Figure 5 An anterior view of an implant 10 wrapped with an implant fixation device 100 and mounted on a patient's chest wall or pectoralis muscle 20 is shown. As shown, a central portion 111 of the device 100 can cover a portion of the breast implant 10 to facilitate tissue ingrowth around the implant. The legs 110 can be wrapped around the other side of the implant so that the tabs 115 are transformed into an orientation that points away from the central portion. Thus, the tabs can extend outward from the device when mounted on the patient's anatomy. In this way, the tabs 115 can allow the surgeon to secure the device 100 to the patient's anatomy. In some embodiments, as shown in FIG. Figure 5 As shown in , the tab 115 can be sewn 119 to the chest 20. In other embodiments, other fasteners can be used, including but not limited to staples, tacks, barbs, hooks, adhesives, and combinations thereof. In some embodiments, as Figure 5 As shown in , each tab 115 can be fixed to the anatomical structure 20, while in other embodiments, a subset of the tabs can be fixed to the anatomical structure. The surgeon can choose to fix the device to the anatomical structure through any one or more of the tabs of the device.

[0099] Figure 5 1 shows a fastening device 100 having a tab 115 formed in the body of the leg 110. Thus, when the device is in the wrapped configuration, as shown in FIG. Figure 5 As shown in , the tabs 115 may extend out of the plane of the legs and leave openings 118. These openings may not be present in embodiments where the tabs are formed separately and attached or otherwise coupled to the device.

[0100] As previously described, the legs 110 can form spaces 112 between adjacent legs to allow the device 100 to conform to the curvature of the implant 10, thereby reducing the risk of wrinkling and undesirable texture deformation on the implant. The spaces 112 can also allow the device to wrap implants of various sizes without having to repeatedly customize the shape and size of the fixture for the implant. This process can speed up the surgical process, thereby improving the results.

[0101] Figure 6An exemplary fixture 100 wrapped around an implant 10 is shown. The fixture includes six tabs 115 extending away from the central portion of the device in a wrapped configuration to allow a surgeon to fix the implant and device assembly to the patient's anatomical structure. As shown, the tabs 115 can be formed along the legs of the device, leaving an opening 118 when arranged in a wrapped configuration.

[0102] Figure 7 Two separate fixtures 100 with the same design wrapped around two separate implants 10D, 10E with different profile heights are shown. As shown, the spacing between the legs of the fixture enables the device to adapt to implants of different sizes (e.g., different profile heights or base diameters in the case of breast implants) without having to change the shape of the device. In this way, the fixture can be standardized to adapt to various implants within a desired size range. As previously mentioned, in some embodiments, the device can be formed into various standard sizes (e.g., small, medium, large, extra-large) to accommodate a wide range of breast implants. In some embodiments, various fixtures can cover 90% of conventional breast implant sizes.

[0103] Figure 8 Another embodiment of an implant fixation device 200 is shown. Fixation device 200 may include a central portion 211 to accommodate a breast (and / or other soft tissue) implant. Central portion 211 may be pre-formed with a curvature such that the central portion is sized and shaped to at least partially conform to a forward-facing surface of a breast implant. In some embodiments, the fixation device 200 may include a central portion 211 to accommodate a breast (and / or other soft tissue) implant. Central portion 211 may be pre-formed with a curvature such that the central portion is sized and shaped to at least partially conform to a forward-facing surface of a breast implant. Figures 2 to 7 Compared with the device 100, Figure 8 The device 200 can provide more spatial coverage for the breast implant. The curvature of the central portion 211 can reduce the possibility of wrinkles or other surface deformation due to its conformal contact with the underlying breast implant.

[0104] In some embodiments, the central portion 211 can be thermoformed and / or compression formed to form and maintain a generally three-dimensional shape prior to being wrapped around a breast implant. Thus, the expanded configuration of the device 200 may not be generally two-dimensional in the expanded configuration, such as Figures 2 to 7 The device 100 of the present invention is described in detail below. Any suitable conventional forming technique may be used. For example, the device 200 may be formed of a thermoplastic two-dimensional porous repair fabric that may be arranged in a mold having the curvature of a breast implant, and the mold may be exposed to heat or compressive forces to help maintain the shape of the mold. In some embodiments, the device may be quenched or otherwise treated to enhance specific properties of the material. It should be understood that any suitable molding or forming technique may be used to produce the curvature of the central portion, as the present disclosure is not limited by the forming technique.

[0105] like Figure 8 As shown in , implant fixation device 200 may include an outer peripheral edge 213 that extends outwardly around the periphery of central portion 211 and extends outwardly at least partially around the periphery of central portion 211, and in some cases completely around the periphery of central portion 211. During an exemplary procedure, a breast implant may be positioned within central portion 211, thereby aligning any potential curvature of the implant with the device, and outer peripheral edge 213 may be wrapped around the dorsal portion of the implant. Edge 213 may be similar to Figures 2 to 7 The legs of the device 100 of the invention function because the rim 213 can be used to hold the implant in the fixture. The peripheral rim 213 can be arranged to wrap around the implant, thereby forming a shell or covering for the implant.

[0106] In some embodiments, the central portion 211 can have a maximum diameter D4 that can accommodate the implant. Thus, the maximum diameter D4 of the device 200 can be approximately equal to or slightly smaller than the maximum diameter D1 of the implant, such as Figure 1 It should be appreciated that the central portion 211 may include at least some elasticity and be able to expand slightly due to the applied force, so that the maximum diameter D4 of the central portion 211 can be less than or equal to the diameter D1 of the implant. Similarly, the device 200 can have a profile height H1 that is substantially equal to or slightly less than the profile height H1 of the implant, as shown in FIG. Figure 1 Of course, embodiments are also conceivable in which the profile height of the device is slightly greater than the profile height of the implant.

[0107] The peripheral edge 213 of the device 200 may have a maximum diameter D5, which may correspond to Figure 2 211. In some embodiments, the average rim diameter D5 can 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 can be long enough to extend at least halfway across the base diameter. Therefore, the diameter D5 of the peripheral rim can be approximately equal to twice the diameter D4 of the central portion. The diameter D5 of the peripheral rim can be any suitable ratio of the diameter D4 of the central portion, including but not limited to greater than or equal to approximately 125%, 150%, 180%, 200%, 250%, 300%, and / or less than or equal to approximately 300%, 250%, 200%, 180%, 150%, 125%, and combinations thereof, and / or any other ratio.

[0108] It should be understood that the implant device can have any suitable size and geometry (e.g., diameter of the central portion, profile height, etc.) to accommodate the desired implant size, as the present disclosure is not limited thereto. It should also be understood that, although the peripheral edge is shown as being radially symmetrical around the central portion 211, embodiments in which the edge is asymmetrical around the central portion can also be envisioned.

[0109] Fig. 9 Device 200 is shown according to some embodiments. Device 200 can be formed of a porous biocompatible material and can include a central portion 211 having a generally circular shape to accommodate the curvature of an implant (eg, a permanent breast implant) and an outer peripheral edge 213 . Fig. 9 The device 200 is shown in its expanded configuration prior to assembly with an implant. As shown, the device can be in a generally three-dimensional configuration prior to assembly.

[0110] Fig.10 Shown is a silicone breast implant assembled with Fig. 9 The device 200 is similar to the device shown in FIG. The peripheral edge 213 of the device can be wrapped around the implant to provide external coverage of the implant. In some embodiments, the tether 120 can be used to help tether the peripheral edge 213 from (e.g., Fig. 9 The deployed configuration shown in FIG. Fig.10 The tether 120 may include a hand-held portion 125 to allow the surgeon to apply tension to the tether and wrap the implant in the fixture without having to manually manipulate the edges. As previously described, the tether may be woven through or otherwise coupled to an outer portion of the peripheral edge of the fixture to facilitate a drawstring effect.

[0111] FIG. 11A to FIG. 11D A fixation device 300 according to some embodiments is shown. The fixation device 300 may include a curved central portion 311 and one or more legs 310 extending from the central portion. The central portion 311 may have a generally hemispherical shape to correspond to the curved surface of a breast implant. In some embodiments, the central portion 311 may be provided in a pre-formed shape. Any suitable technique may be used, such as using a Figure 8 The technique described for the device 200 is used to pre-shape the central portion. FIG. 11A to FIG. 11B The device 300 is shown partially mounted 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 wrinkling or other undesirable structural deformation.

[0112] In some embodiments, the maximum diameter of the central portion 311 of the device 300 can be smaller than the maximum diameter of the implant 10, so that the legs 310 can extend partially over the curved anterior surface of the breast implant, such as Fig.11A Thus, as shown, a portion of the legs 310 may also be pre-formed into a curved shape. As previously described, the spacing 312 between the legs may enable the device 300 to accommodate a variety of different implant types.

[0113] In some embodiments, the device can be adjusted to improve the conformal fit of the central portion. For example, the device may include one or more apertures 319 extending from an outer surface of the device oriented away from the implant to an inner surface oriented toward the implant when the implant is disposed in the device. Sutures may be passed through the apertures and subsequently tensioned to secure the central portion against the implant or otherwise adjust the central portion against the implant. In some embodiments, aperture 319 may be a large aperture specifically designed to facilitate adjustment of the central portion, or in some embodiments, aperture 319 may represent one or more apertures in a repair fabric forming the device. Similarly, the device may include one or more apertures 317 located on the legs 310 through which sutures may be passed to facilitate the removal of the device from the implant. FIG. 11A to FIG. 11B The expanded configuration shown in is reconstructed as FIG. 11C to FIG. 11D It should be understood that the pores 319 may be macropores disposed in the legs, or the pores 319 may be a subset of the pores of the porous substrate forming the device in some embodiments. As previously described with respect to the devices 100, 200, the fixture 300 may be reconfigured as FIG. 11C to FIG. 11D The wrapping configuration shown in helps cover the implant and provide a biocompatible scaffold for tissue ingrowth.

[0114] Fig.12 An exemplary fixation device 300 formed from a biocompatible porous substrate is shown. The device 300 can include a curved central portion 311 and one or more legs 310 extending outwardly from the central portion. Fig.12 The device 300 is shown in its expanded configuration prior to being mounted on an implant. In this expanded configuration, the device can 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 can have any suitable number of legs 310 in any suitable arrangement (e.g., symmetrical or asymmetrical arrangement) around the central portion to help distribute the load of the implant. Tethers (not shown) can be used to quickly wrap the legs 310 of the device 300 around the implant to provide a biocompatible scaffold for tissue ingrowth.

[0115] FIG. 13A to FIG. 13DThe process of wrapping an implant fixation device 400 around an implant 10 is shown according to some embodiments. The device 400 may include: a central portion 411, the central portion 411 is configured to wrap around the curved front portion of the permanent implant 10; and a series of radiating legs 410, the legs 410 are arranged around the central portion 411. The legs 410 can be arranged to span around the implant 10 to the back, flatter portion of the implant. In some embodiments, as Fig.13A As shown in , the legs 410 may include a series of groups, each group including a pair of legs 410A, 410B. Thus, the device 400 may include a central diameter D6 measured radially around the root portion of each pair of legs, and an intermediate diameter D7 measured radially around the point where each leg 410A, 410B branches away from its pair. It should be understood that any suitable ratio between the central diameter D6 and the intermediate diameter D7 may be used, as the present disclosure is not limited by the geometry of the legs 410. In some embodiments, the fixing device may include a tether 120, which may be pre-threaded through the legs 410, such as Fig. 13B The tether 120 can have a free distal end that can be tensioned to help wrap the legs 410 around the implant 10.

[0116] In some embodiments, the process of wrapping the fixation device 400 around the implant may include first laying out the device 400 into an expanded configuration, such as Fig.13A The implant 10 can then be placed on the central portion 411 of the device 400, as shown in FIG. Fig. 13B The clinician can then apply tension to the tether 120 passing through one or more legs 410 of the device 400 to help transform the device into a wrapped configuration, such as FIG. 13C to FIG. 13D As shown in Fig. 13C As shown in FIG. 1 , a portion of the leg 410 can be arranged around the curved surface of the implant 10, while the remainder of the leg 410 can be positioned on the dorsal side of the implant, as shown in FIG. Fig.13D In some embodiments, the tether 120 may be knotted or otherwise secured to reduce the risk of the tether untangling and transforming the securement device back to the deployed configuration.

[0117] FIG. 13A to FIG. 13D The implant fixture 400 can accommodate any size of implant 10, including any of the above-mentioned ranges of sizes. For example, the fixture can be used with a 250cc or 350cc implant.

[0118] Fig.14An exploded view of an implant fixture device 500 according to some embodiments is shown. The device 500 can be formed of three components, including a central portion 501 configured to wrap around a central curved portion of the fixture; and two dorsal portions 502, 503 configured to wrap around a flatter dorsal portion of the implant. In some embodiments, the central portion 501 can be formed in a generally circular manner, such as Fig.14 , although other non-circular geometries are also contemplated. The back portions 502, 503 may be formed as partial circles. In some embodiments, the back portions may be larger than a semi-circle, such that the back portions may overlap each other when the device 500 is assembled.

[0119] FIG. 15A to FIG. 15B The assembly is shown with a suture or thread 120. Fig.14 The device 500 of the present invention can be provided. Suture 120 can be passed around the periphery of the central portion and the dorsal portion to form a pocket therein. The implant can be inserted into the device through the opening between the overlapping dorsal portions. Fig.15A A bottom view of the assembled device 500 is shown showing the overlapping back side portions 502 , 503 . Fig. 15B A top view of device 500 is shown, wherein central portion 501 spans the entire front side of device 500 .

[0120] FIG. 16A to FIG. 16C The implant 10 is shown wrapped around Figures 14 to 15B The implant fixing device 500, the implant 10 can be Fig.16A As mentioned above, the implant can be inserted into the pocket between the central part 501 and the dorsal parts 502, 503 through the groove formed between the two dorsal parts, which can be Fig. 16B Seen in the bottom view. Fig. 16C A perspective view of the implant 10 installed in the device 500 and the suture 120 extending around the periphery of the device 500 is shown.

[0121] It should be understood that although Figures 14 to 16C The device 500 is shown as being formed from three sheets of material, but embodiments formed from less than or greater than three sheets of material are also contemplated. For example, a single preformed sheet of porous absorbable material may be used to wrap around the front and back portions of the implant.

[0122] Although some of the drawings relating to embodiments of three-dimensional preformed implant fixtures do not include fixation tabs, it should be understood that the three-dimensional preformed implant fixtures are not intended to be construed as having fixation tabs. Figure 2The tabs can be used with any fixation device described herein, including using the tabs on the legs and peripheral edges of the above-mentioned three-dimensional preformed implants. However, in some embodiments, the fixation device may not include a fixed tab, and a portion of the device may be fixed directly to the patient's anatomical structure.

[0123] The foregoing description of various embodiments is intended to be illustrative of the embodiments only and other embodiments, modifications, and equivalents are also within the scope of the present disclosure.

[0124] For purposes of this patent application and any patent issued thereon, the indefinite articles "a" and "an" as used herein in the specification and claims shall be understood to mean "at least one", unless expressly indicated to the contrary. The phrase "and / or" as used herein in the specification and claims shall be understood to mean "one or both" of the elements so combined, i.e., elements present in combination in some cases and separately in other cases. Multiple elements listed with "and / or" shall be interpreted in the same manner, i.e., "one or more" of the elements so combined. In addition to the elements specifically indicated by the "and / or" clause, other elements may optionally be present, whether related or unrelated to those elements specifically indicated.

[0125] The use of "including," "comprising," "having," "containing," "involving," and / or variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0126] The embodiments described herein can be implemented as methods, examples of which have been provided. The actions performed as part of the method can be ordered in any suitable manner. Thus, embodiments can be constructed in which the actions are performed in a sequence different from the illustrated sequence, and embodiments can include performing some actions simultaneously, even if these actions are shown as sequential actions in illustrative embodiments.

[0127] Although the present teaching has been described in conjunction with various embodiments and examples, it is not intended to limit the present teaching to these embodiments or examples. On the contrary, as will be appreciated by those skilled in the art, the present teaching includes various alternatives, modifications and equivalents. Therefore, the foregoing description and accompanying drawings are only examples.

[0128] Although several embodiments of the present invention have been described and illustrated herein, it will be readily apparent to those of ordinary skill in the art that various other devices and / or structures for performing functions and / or obtaining one or more of the results and / or advantages described herein will be contemplated, and each of such variations and / or modifications is considered to be within the scope of the present invention. More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications for which the teachings of the present invention are used. Those skilled in the art will recognize or be able to determine many equivalents of the specific embodiments of the present invention described herein using only routine experiments. Therefore, it should be understood that the aforementioned embodiments are presented only by way of example, and within the scope of the appended claims and their equivalents, the present invention can be practiced in a manner other than specifically described and claimed. The present invention relates to each individual feature, system, product, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits and / or methods is also included within the scope of the present disclosure if such features, systems, articles, materials, kits and / or methods are not inconsistent with each other.

Claims

1. An implant fixing device, which is used to fix an implant in a patient's body, characterized in that: The implant fixing device comprises: a central portion sized and shaped to at least partially cover the first surface of the implant; and a peripheral portion extending radially away from the central portion; wherein the peripheral portion includes at least one tab extending radially toward the central portion in a first orientation when the implant fixture device is in a first expanded configuration, and wherein the implant fixture device is formed of a porous biocompatible material.

2. The implant fixation device according to claim 1, characterized in that: When the implant fixation device is in the second wrapped configuration, the at least one tab extends radially outward from the central portion in a second orientation.

3. The implant fixation device according to claim 1, characterized in that: The peripheral portion includes a plurality of legs.

4. The implant fixation device according to claim 3, characterized in that: The at least one tab includes a plurality of tabs.

5. The implant fixation device according to claim 4, characterized in that: Each tab of the plurality of tabs is disposed on a separate leg of the plurality of legs.

6. The implant fixation device according to claim 1, characterized in that: When the implant fixation device is in the first expanded configuration, the central portion is substantially two-dimensional.

7. The implant fixation device according to claim 1, characterized in that: The central portion is preformed into a generally three-dimensional shape configured to receive the implant therein.

8. The implant fixation device according to claim 1, characterized in that: The maximum transverse dimension of the central portion is less than the maximum base diameter of the implant.

9. The implant fixation device according to claim 1, characterized in that: Also included is a tether coupled to the peripheral portion, the tether being configured to be tensioned to pull the peripheral portion radially inwardly to at least partially enclose the implant between the central portion and the peripheral portion when the implant fixture is in the second wrapped configuration.

10. The implant fixation device according to claim 1, characterized in that: The implant fixation device is formed from poly-4-hydroxybutyrate.

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

12. An implant fixing device, used for fixing an implant in a patient's body, characterized in that: The implant fixing device comprises: a central portion sized and shaped to at least partially cover the first surface of the implant; a peripheral portion extending radially away from the central portion when the implant fixation device is in a first, expanded configuration; and A tether is connected to the peripheral portion, the tether being configured to be tensioned to pull the peripheral portion radially inward to at least partially enclose the implant between the central portion and the peripheral portion when the implant fixture is in a second wrapped configuration, wherein the implant fixture is formed of a porous biocompatible material.

13. The implant fixation device according to claim 12, characterized in that: The tether is woven through the apertures of the peripheral portion.

14. The implant fixation device according to claim 12, characterized in that: The tether is formed from a substantially inelastic material.

15. The implant fixation device according to claim 12, characterized in that: Also included is at least one tab extending radially toward the central portion in a first orientation when the implant fixation device is in the first expanded configuration.

16. The implant fixation device according to claim 15, characterized in that: The peripheral portion includes a plurality of legs, wherein the at least one tab includes a plurality of tabs, and wherein each tab of the plurality of tabs is disposed on a separate leg of the plurality of legs.

17. The implant fixation device according to claim 12, characterized in that: When the implant fixation device is in the first expanded configuration, the central portion is substantially two-dimensional.

18. The implant fixation device according to claim 12, characterized in that: The maximum transverse dimension of the central portion is less than the maximum base diameter of the implant.

19. The implant fixation device according to claim 12, characterized in that: The central portion is preformed into a generally three-dimensional shape configured to receive the implant therein.

20. The implant fixation device according to claim 12, characterized in that: The implant fixation device is formed from poly-4-hydroxybutyrate.

21. The implant fixation device according to claim 12, characterized in that: The implant is a breast implant and wherein the first surface is an anterior surface of the implant.

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