Breast implant wrap for limiting movement of breast implant and related method

Abstract

To provide a breast implant fixation device used in breast reconstruction and augmentation surgery.SOLUTION: New wrap is designed to avoid lateral displacement and being the lowest position of breast implants, reduce capsular contraction and extrusion of the implants, eliminate skin dimpling and wrinkles caused by the breast implants, and reduce or eliminate easy perception. The wrap is adapted to be folded tightly around the breast implants so as to limit relative movement between the wrap and the breast implants and reduce wrinkles. Tissue ingrowth into the wrap limits movement of the wrap-breast implant assembly, thereby limiting movement of the breast implants.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] FIELD OF THE INVENTION FIELD OF THE INVENTION

[0001] The present invention relates generally to the field of surgery, and more particularly to implantable medical devices that limit breast implant movement after breast reconstruction, including augmentation mastopexy. [Background technology]

[0002] Background of the Invention Post-mastectomy breast reconstruction has become an essential part of surgical breast cancer treatment, providing both aesthetic and psychological / social benefits to patients. Currently, nearly 65% ​​of breast reconstruction procedures in the United States use a tissue expander (TE), which is temporarily implanted in the breast to create a pocket for a permanent breast implant in the first step of the procedure. To reduce postoperative pain, tissue expanders are now often placed above the pectoral muscles rather than below them (pre-pectoral placement). Once the pocket is created, the TE is removed and replaced with a permanent breast implant in the second step. However, in some patients, it is possible to create a breast implant pocket after mastectomy without the use of a TE.

[0003] Breast implants can also be used in breast augmentation and mastopexy procedures to increase breast size. In the latter procedure, a breast lift is combined with breast augmentation surgery. Most commonly, breast implants are placed in a pocket beneath the breast tissue, but in some cases, they are implanted beneath the chest wall.

[0004]

[0004] Breast implants vary in size, shape, and surface texture. A wide variety of different sizes are available, allowing surgeons and patients to choose from a range of prominence, 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, microtextured, or macrotextured. Siltex 1600 microtextured breast implants, for example, have a surface with small open pores, 70-150 μm in diameter and 40-100 μm deep, while Biocell RTV macrotextured breast implants have larger open pores, 600-800 μm in diameter and 150-200 μm deep (Damino et al. Comparison of the capsular response to the Biocell RTV and Mentor 1600 Siltex breast implant surface texturing: a scanning electron microscopic study, Plastic and Reconstructive Surgery, 2001, 108(7), 2047-2052).

[0005]

[0005] Breast implant texturing was initially used as a method to limit breast implant rotation and movement. However, recent studies using high-resolution ultrasound have found that macrotexturing is not sufficient to prevent breast implant rotation. For example, Sieber et al. (Clinical evaluation of shaped gel breast implant rotation using high-resolution ultrasound, Aesthetic Surgery Journal, 2017, Vol. 37 (3), 290-296) reported a 27% rate of breast implant rotation in patients receiving anatomical breast implants manufactured by Mentor and Allergan. Furthermore, surprisingly, 26% of breast implants examined were rotated ≥ 45° from the midline. Sieber et al. concluded that breast implant rotation occurred in 42% of patients. It is likely that capsule formation around the breast implant prevents the breast implant from being fixed in place.

[0006]

[0006] Clearly, no patient wants to have their anatomical implant rotated, only to find that the thicker portion of the implant is no longer located at the bottom of the breast, but instead is located at the side or even at the top of the breast, especially when the only way to resolve the problem is with further surgery.

[0007] Concerns about the use of macrotextured anatomical breast implants are not limited to undesirable implant rotation, which can result in a suboptimal appearance of the breast. Growing evidence links the use of these implants to a significant increase in cases of anaplastic large cell lymphoma (ALCL), a rare, potentially life-threatening form of peripheral T-cell lymphoma (Leberfinger et al., Breast-implant associated anaplastic large cell lymphoma: a systematic review, JAMA Surg. 2017, Dec 1;152(12), 1161-1168). Chronic inflammation caused by the macrotexturing of anatomical breast implants is thought to be the underlying mechanism. Chronic inflammation is thought to potentially induce malignant transformation of T cells, leading to cancer of the immune system. Treatment for lymphoma involves removing the patient's implant and the capsule surrounding it; in more advanced cases, patients may require additional treatment, including radiation therapy, chemotherapy, and lymph node dissection. Breast Implants - Due to the rise in cases of ALCL, the FDA is advising patients to consider the risks associated with breast implants with macro-textured surfaces as well as smooth surfaces, and some surgeons are reducing or discontinuing their use of macro-textured breast implants.

[0008] Although rotation of smooth breast implants does not necessarily alter the appearance of the breast, breast implant-ALCL has been reported in patients with smooth breast implants, albeit at a lower incidence than in patients with macrotextured anatomical implants. Furthermore, capsular contraction, which results from thickening of the thin, flexible capsule that initially surrounds the implant, has been reported to be higher in smooth implants than in anatomical implants (Damino, et al., Comparison of the capsular response to the Biocell RTV and Mentor 1600 Siltex breast implant surface texturing: a scanning electron microscopic study, Plast. Reconstr. Surg. 2001, 108(7), 2047-2052). While the reasons for the higher rates of capsular contraction are not fully understood, it is hypothesized that the higher rates of capsular contraction are due to the higher rates of rotation and greater movement of smooth, rounded breast implants. Capsular contraction can be a serious problem and is relatively common. This shrinkage can occur immediately after implantation or 20 to 30 years later. The shrinkage of the capsule that forms around the implant can cause chronic pain and a feeling of pressure around the breast. This can be treated by a capsulotomy, in which the implant is removed, the capsule is opened, and the implant is replaced. Alternatively, the shrinkage of the capsule can be treated by a capsulectomy, in which both the implant and capsule are removed and a new implant is implanted into the patient. It would be desirable to avoid the need to perform these procedures.

[0009] In addition to problems associated with breast implant rotation, any type of breast implant movement is undesirable because it results in an unnatural breast appearance. Although breast implant movement is undesirable, it remains common. In one study of 715 reconstruction patients, 71.5% of patients underwent revision surgery due to implant malposition after 10 years (O'Shaughnessy, 2015, Evolution and update on current devices for prosthetic breast reconstruction, Gland Surgery, 4(2):97-110). Breast implant displacement can occur when the implant pocket is not precisely shaped, and physical activity can also lead to implant displacement. Implant movement can also occur when the supporting tissue around the implant stretches or thins, or when the tissue loses elasticity. These situations can result, for example, in the implant moving further downward, resulting in a "lowest position" condition that results in an unattractive appearance. (See Slavin, 2012, The use of acellular dermal matrices in revisional breast reconstruction, Plast. Reconstr. Surg. 130 (Suppl. 2): 70S-85S.) These conditions can also lead to lateral stretching of the implant pocket, causing the patient's breast implant to move laterally toward the patient's side, or axilla, especially when lying down.

[0010]

[0010] Various implantable devices have been developed to create pockets for breast implants or for use as slings in breast reconstruction. Acellular dermal matrix (ADM), for example, has been used to cover tissue expanders (Bertozzi, N. Ann Med Surg. 21:34-44 (2017)). In a typical procedure, the pectoralis major muscle is mobilized, and an ADM is attached to the muscle edges to create a sling and submuscular pocket for the tissue expander. The use of an ADM eliminates the need to release and elevate the serratus anterior, pectoralis minor, and rectus abdominis fascia, thus reducing postoperative pain. However, such devices are not designed to limit breast implant rotation.

[0011]

[0011] U.S. Patent No. 4,936,858 to O'Keeffe also discloses pouches for breast implants made of non-biodegradable thread. The pouch diameter is approximately 20% larger than the diameter of the implant. The pouch is not designed to restrict rotation of the breast implant.

[0012]

[0012] U.S. Patent No. 7,520,896 to Benslimane shows a breast implant in which a support element (5) is attached to the breast implant using an adhesive (4), and a securing element (3) is connected to the support element. The support element (5) can be attached to the patient's pectoral muscle or in the axillary region. Figure 5 of Benslimane shows a breast implant that includes two packages, an outer package and an inner package, designed to prevent contamination of the breast implant with microorganisms. The outer package is non-sterile. However, the pouch is not designed to restrict rotation or movement of either breast implant, and because the outer package is non-sterile, it is not designed for implantation.

[0013]

[0013] Hunter's U.S. Patent Application Publication No. 20070196421 discloses a sleeve for a breast implant containing a fibrosis-inhibiting drug, but does not disclose a sleeve designed to limit rotation of the breast implant.

[0014]

[0014] U.S. Patent Application Publication No. 20080128315 to Buevich discloses a resorbable pouch for an implantable medical device, but does not disclose a pouch for a breast implant or a pouch designed to limit rotation of a breast implant.

[0015]

[0015] U.S. Patent Application Publication No. 20020165596 to Wilson discloses a resorbable pouch for placing a bone graft or bone graft substitute, but does not disclose a pouch for a breast implant or a pouch designed to limit rotation of a breast implant.

[0016]

[0016] US Patent No. 5,383,929 to Ledergerber discloses a cover for an implant that disrupts scar tissue at the implant / body interface. The cover is preferably made from expanded PTFE, a non-degradable polymer.

[0017]

[0017] WO 2019 / 094861 to Mlodinow discloses a mesh pouch for securing an implant within a patient's body. The mesh pouch can be used to support a breast implant.

[0018]

[0018] Janhofer et al., The suture tab technique: Securing implant position in prepectoral breast reconstruction, Plast Reconstr Surg Glob Open, 2018; 6:e2005 discloses the use of an ADM to secure breast implants. Summary of the Invention [Problem to be solved by the invention]

[0019]

[0019] Notwithstanding the above, there remains a need for breast implant fixation devices described herein that can limit breast implant movement and rotation and reduce capsular contraction. In particular, there is a need for the development of a breast implant fixation device that can eliminate the need to rely on breast pocket anatomy to achieve a desired anatomical position for the breast implant. Such breast pockets can be highly variable and inconsistent, especially after mastectomy, making it difficult to maintain the correct vertical positioning and inferolateral stability of the breast implant. There is also a need for the development of a breast implant fixation device that not only limits breast implant movement, but also prevents the breast implant from being easily palpable or hides any ripples or indentations in the breast resulting from the implantation of the breast implant. Such a device would provide improved aesthetic outcomes for patients. There is also another need for a breast implant fixation device that makes it easier to position and secure a breast implant and minimizes breast implant movement, migration, and the effects of gravity on the breast implant. [Means for solving the problem]

[0020] Summary of the Invention

[0020] Medical devices that limit breast implant movement are described herein. In several embodiments, the breast implant may be at least partially covered by a breast implant securement device including a porous polymer two-dimensional wrap. The wrap may be fastened within the breast, thereby minimizing breast implant movement. The wrap may further include one or more tabs to provide additional sites for securement of the wrap within the breast. The wrap or tabs may be fastened to the pectoralis major muscle and / or the patient's chest wall. The wrap or tabs may be sutured or stapled to secure and fasten the wrap within the patient's breast. The wrap may also prevent the breast implant from being easily felt or prevent the formation of fine lines or dimplings on the skin following placement of the breast implant within the breast. The wrap limits breast implant movement by allowing tissue ingrowth into the wrap and by fastening the wrap to the chest wall. The breast implant may be fully or partially encased in the wrap. The wrap eliminates the problem of palpability or the formation of skin dimpling and fine lines by providing a layer between the patient's skin and the breast implant.

[0021]

[0021] Methods for preparing the wraps are also described. The wraps are preferably made of absorbable polymers, most preferably poly-4-hydroxybutyrate (P4HB) and its copolymers, or poly(butylene succinate) or its copolymers. The wraps are preferably prepared with a porosity that allows for tissue ingrowth and fastening of the wrap at the implantation site. Preferably, the wraps are prepared from fibers, most preferably monofilament fibers or dry-spun fibers. Preferred methods for manufacturing the wraps include knitting and dry-spinning.

[0022] Also disclosed are methods for using a wrap with breast implants in breast reconstruction and augmentation surgery, such as mastopexy. The breast implants can be filled, for example, with silicone or saline. The wrap can be used following a mastectomy and can be used in either a one-stage or two-stage breast reconstruction procedure. In the latter case, a preferred method includes mobilizing the pectoralis major muscle, optionally attaching a textile comprising acellular dermal matrix, P4HB textile, or polybutylene succinate or a copolymer thereof to the elevated pectoralis major muscle to create a submuscular pocket for a tissue expander (TE), inflating the TE, removing the TE, and implanting the wrap containing the breast implant into the submuscular pocket.

[0023] In breast augmentation procedures, the wrap containing the breast implant may be placed in a breast pocket created in either a subglandular position (above the pectoral muscle) or a submuscular position (below the pectoral muscle), with the former being preferred. When used in breast augmentation surgery, the wrap and breast implant may be inserted using a transaxillary or transumbilical method, or following a peri-areolar incision or an incision at the inframammary fold (IMF).

[0024] A wrap for a breast implant to prevent movement of the breast implant within a patient includes a base section, a cover section, and a hinge region connecting the base section to the cover section. Each of the base section and cover section, and optionally the hinge region, is made of a material that includes a plurality of pores for tissue ingrowth. The wrap preferably includes one or more connectors that can be used to secure the breast implant within the wrap.

[0025] Preferably, the wrap includes one or more tabs to provide additional anchoring sites for the wrap within the breast. More preferably, the wrap includes a superior tab. The superior tab can be used to anchor the wrap to the pectoralis major muscle to maintain the vertical orientation of the breast implant, prevent inferolateral instability, and minimize implant movement.

[0026] In some embodiments, the breast implant fixation device includes a wrap that includes a substantially 2D planar first configuration and a 3D second configuration when the breast implant is encased in the wrap.

[0027]

[0027] In another embodiment, the breast implant fixation device includes a wrap including a cover section for placement between the breast implant and the patient's skin and a base section for placement against the patient's chest wall.

[0028] In some embodiments, the breast implant fixation device includes a wrap including a base section, a cover section, and a hinge region. The base section, cover section, and hinge region can form a two-dimensional unitary unit that can be formed into a three-dimensional shape to at least partially cover a breast implant.

[0029]

[0029] In some embodiments, the breast implant securement device includes a wrap including a connector that secures the breast implant within the wrap. The connector preferably connects the cover section to the base section.

[0030] In some embodiments, the breast implant securement device includes a wrap having a cover section and a base section, and may further include one or more securement tabs. The securement tabs may be located on the cover section or the base section. In some embodiments, the wrap includes a securement tab that is located on top of the wrap when the breast implant is at least partially covered by the wrap and positioned in the breast.

[0031] In an alternative embodiment, the breast implant securement device includes a base section and a cover section, which are separate from one another. The device can be assembled to encase the breast implant by placing the breast implant in the base section of the device, placing the cover section over the front of the breast implant, and securing the base and cover sections around the breast implant. More preferably, the cover section has a three-dimensional shape formed to cover the front of the breast implant. Each of the base and cover sections is made of a material containing a plurality of pores for tissue ingrowth. The base section, the cover section, or both sections can further include one or more connectors that can be used to secure the base and cover sections around the breast implant to form a wrap.

[0032] In several embodiments, the breast implant securement device includes a wrap formed at least in part from one or more elastic materials, and preferably the cover section of the wrap has a higher elasticity than the base section of the wrap. More preferably, the elasticity of the cover section of the wrap increases from the area contacting the top of the breast implant to the area contacting the bottom of the breast implant when the breast implant is contained within the wrap and positioned in the breast. The elasticity of the wrap facilitates wrapping the breast implant and allows the wrap to conform tautly around the breast implant. The stretchability of the cover section of the wrap allows the wrap to be draped over the convex portion of the breast implant.

[0033] In some embodiments, the breast implant fixation device includes a two-dimensional first form including a base section, a cover section, and a hinge region connecting the base section to the cover section; and a second three-dimensional form including a shape and size such that the cover section wraps around the front of the breast implant and at least partially covers the breast implant when secured to the base section, the cover section having a greater elasticity than the base section. In some embodiments, the cover section has a greater elasticity than the base section, between 15% and 75%. In some embodiments, the base section has a greater elasticity than the base section, preferably at least 5% and less than 25%, unless the cover section has a less elasticity than the base section, in which case the elasticity is less than 25%.

[0034] In some embodiments, the base section and the cover section include a plurality of pores, and in some embodiments, the average diameter of the pores in the cover section is smaller than the average diameter of the pores in the base section.

[0035] In some embodiments, the breast implant fixation device includes one or more tabs to secure the device within the patient.

[0036] In some embodiments, the thickness of the cover section of the device exceeds the thickness of the base section of the device. In some embodiments, the base section of the device is formed from a first mesh and the cover section is formed from a second mesh. In some embodiments, the resiliency of the second mesh exceeds the resiliency of the first mesh.

[0037]

[0037] In several embodiments, the breast implant fixation device includes fibers in a base section and a cover section, and the average diameter of the fibers in the base section is greater than the average diameter of the fibers in the cover section.

[0038] In some embodiments, the breast implant fixation device includes a wrap having a cover section and a base section, and the cover section of the wrap is thicker than the base section of the wrap. When the wrap containing the breast implant is placed in the breast, the cover section is placed between the patient's skin and the breast implant to minimize the formation of fine lines or indentations in the patient's skin and reduce the breast implant's visibility.

[0039]

[0039] In several embodiments, the breast implant fixation device comprises a wrap formed from a textile, a woven textile, a knitted textile, a nonwoven textile, a monofilament mesh, a multifilament mesh, or a dry-spun textile.

[0040]

[0040] In another embodiment, the breast implant fixation device includes a wrap including a base section for placement on the patient's chest wall, a bottom cover section for placement on the anterior lower pole of the breast, an upper cover section for placement on the anterior superior pole of the breast, and an intermediate cover region between the bottom cover section and the upper cover section for placement under the patient's skin; and the wrap is porous to allow tissue ingrowth and limit movement of the breast implant.

[0041]

[0041] In several embodiments, the breast implant fixation device includes a wrap, and one of the mechanical properties selected from the group consisting of porosity, thickness, and elasticity varies along the cover section of the wrap from an area located at the upper pole of the breast to an area located at the lower pole of the breast.

[0042] In some embodiments, the breast implant securement device includes a wrap, and the porosity of the wrap is adjusted to facilitate encasing the breast implant within the wrap, particularly when the breast implant is round. In some embodiments, the breast implant securement device includes larger pores in the base of the wrap, providing a less dense wrap that is easier to put on. In some embodiments, the breast implant securement device includes smaller pores in the cover section of the wrap, increasing the surface area of ​​the cover section of the wrap compared to the base of the wrap and increasing the surface area that can retain or be coated with fat.

[0043]

[0043] In several embodiments, the method includes applying fat to the cover of the wrap, and in certain embodiments, autologous fat is applied or otherwise provided to the front of the wrap prior to transplantation.

[0044]

[0044] In several embodiments, the breast implant fixation device includes a wrap that can be shaped to fit around the breast implant to prevent movement of the breast implant, the wrap adapted to engage the breast implant and prevent substantial rotation of the breast implant within the wrap; and the wrap further includes a plurality of outwardly extending (or protruding) anchors, and the anchors are characterized by a fibrous or filament-type structure, and optionally the density of the anchors can range from 10 to 50 anchors per square cm, and optionally 20 to 30 anchors per square cm.

[0045] In some embodiments, a breast implant wrap for restricting movement of a breast implant within a patient includes a thin, sheet-like, two-dimensional first form. The first form further includes a base section, a cover section, and a hinge region connecting the base section to the cover section. The wrap further includes a three-dimensional second form shaped and sized to at least partially cover the breast implant when the cover section is folded around the front of the breast implant and secured to the base section. In some embodiments, the cover section has a profile selected from the group consisting of: a star, a flower, and a gear.

[0046]

[0046] In view of the above, it is an object of the present invention to provide a medical device, such as a wrap, for use with a breast implant that limits movement, such as migration and rotation, of the breast implant.

[0047]

[0047] Yet another object of the present invention is to provide a breast implant fixation device that limits movement of the breast implant when the breast implant is placed in the breast, prevents the breast implant from being easily perceived, and prevents the formation of any fine lines or indentations.

[0048]

[0048] It is a further object of the present invention to provide a breast implant fixation device that reduces capsular contraction.

[0049]

[0049] It is yet another object of the present invention to provide a method for preparing or manufacturing a wrap that limits movement of a breast implant.

[0050]

[0050] It is yet another object of the present invention to provide a wrap and a method for implanting a breast implant.

[0051]

[0051] These and other objects, aspects, and advantages of the subject invention will become apparent from consideration of the following description when taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0052] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1A] A rear view of a breast implant (100) is shown, with the back (110) of the breast implant positioned against the patient's chest wall (150) and the front (120) of the breast implant positioned just under the patient's skin, the top side (130) of the breast implant positioned at the upper pole (160) of the breast, and the bottom side (140) of the breast implant positioned at the lower pole (170) of the breast. [Figure 1B] A front view of a breast implant (100) is shown, with the back (110) of the breast implant positioned against the patient's chest wall (150) and the front (120) of the breast implant positioned just under the patient's skin, the top side (130) of the breast implant positioned at the upper pole (160) of the breast, and the bottom side (140) of the breast implant positioned at the lower pole (170) of the breast. [Figure 1C]

[0052] A perspective view of the bottom side of a breast implant (100) is shown, with the back (110) of the breast implant positioned against the patient's chest wall (150) and the front (120) of the breast implant positioned just under the patient's skin, the top side (130) of the breast implant positioned at the upper pole (160) of the breast, and the bottom side (140) of the breast implant positioned at the lower pole (170) of the breast. [Figure 1D]

[0052] An in situ side view of a breast implant (100) is shown, with the back (110) of the breast implant positioned against the patient's chest wall (150) and the front (120) of the breast implant positioned just under the patient's skin, the top side (130) of the breast implant positioned at the upper pole (160) of the breast, and the bottom side (140) of the breast implant positioned at the lower pole (170) of the breast. [Figure 2]

[0053] 1 shows a wrap (200) for a breast implant according to an embodiment of the present invention, including a base section (210) of the wrap, a cover section (220) of the wrap, and a hinge (250) joining sections (210) and (220). The cover section includes tabs (230) that insert into slits (240) in the base section (210) to secure the implant within the wrap. [Figure 3]

[0054] 1 shows a wrap (300) for breast implants according to an embodiment of the present invention, including a cover section (320) connected by hinged sections (350) to eight base sections (310) that are folded around the breast implants and interlocked to secure the breast implants within the wrap. [Figure 4]

[0055] A wrap (400) for a breast implant according to an embodiment of the present invention is shown, comprising a base section (410) with a slit (440), a cover section (420) with a tab (430), and a hinge (450) connecting the base section (410) and the cover section (420). [Figure 5]

[0056] A wrap (500) for a breast implant according to an embodiment of the present invention is shown, including a base section (510) with four tabs (530), and a cover section (520) with four slits (540), as well as a hinge region (550) connecting the base section (510) to the cover section (520). [Figure 6]

[0057] FIG. 1 shows a perspective view from the bottom side of a breast implant wrap (600) arranged in a 3D configuration, according to an embodiment of the present invention, with portions of the wrap transparent or removed to more clearly illustrate features that would otherwise be hidden from view. [Figure 7]

[0058] 7 shows a perspective front view of the breast implant wrap (600) shown in FIG. 6. DETAILED DESCRIPTION OF THE INVENTION

[0053] Detailed Description of the Invention

[0059] Before describing the present invention in detail, it should be understood that the present invention is not limited to the particular variations described herein, since various changes or modifications may be made to the described invention without departing from the spirit and scope of the invention, and equivalents may be substituted. As will be apparent to those skilled in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has distinct components and features that may be readily separated or combined with the features of any of the other embodiments without departing from the scope or spirit of the invention. Furthermore, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

[0054]

[0060] Methods described herein may be carried out in any order of the recited events that is logically possible, as well as in the recited order of events. Furthermore, when a range of values ​​is provided, it is understood that every intervening value between the upper and lower limit of that range, and any other stated or intermediate value within that stated range, is also encompassed within the invention. It is also contemplated that any optional features of the described variations of the invention may be set forth and claimed independently or in combination with any one or more of the features described herein.

[0055]

[0061] All existing subject matter (e.g., publications, patents, patent applications, and hardware) mentioned herein is incorporated by reference in its entirety into this specification, unless the subject matter may conflict with the subject matter of the present invention, in which case it is effective as presented herein.

[0056]

[0062] Reference to a singular item includes the possibility of a plurality of the same items. More specifically, in this specification and the appended claims, the singular forms "a," "an," "said," and "the" include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement shall serve the function of the antecedent description with respect to the recitation of claimed elements or the use of exclusive terms such as "solely" or "only," as in connection with the use of a "negative" limitation. Finally, unless otherwise defined, all technical and scientific terms used herein shall be understood to have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0057]

[0063] In embodiments of the present invention, the implantable medical device limits movement of the implanted breast implant, maintains the patient's physical appearance, reduces or eliminates the breast implant's visibility, and reduces the chance of capsular contraction and the occurrence of breast implant-associated lymphoma. Medical devices used to prevent or limit breast implant migration and rotation can be made for use with a wide variety of breast implant types and can be used in breast reconstruction procedures following mastectomy, as well as breast augmentation procedures, including breast implant fixation procedures.

[0058]

[0064] In several embodiments, the medical device is a wrap and is used by at least partially encasing a breast implant within the wrap and securing the breast implant within the wrap. Preferably, the breast implant cannot rotate more than 45 degrees within the wrap, and more preferably, the breast implant cannot rotate more than 30 degrees within the wrap. After securing the breast implant within the wrap, the wrap containing the breast implant is then implanted into the breast by a surgeon. Movement of the breast implant is prevented by tissue growth into the wrap after implantation, which secures or secures the wrap so the breast implant is in place. Preferably, the wrap is made from a synthetic polymer material to reduce the risk of disease transmission associated with implants of human or animal origin.

[0059]

[0065] In several embodiments, the medical device is a breast implant fixation device that includes a wrap, and is utilized by wrapping the wrap around the breast implant to at least partially cover the breast implant. The wrap is porous and allows for tissue ingrowth. The tissue ingrowth secures the wrap in place and prevents migration of the breast implant. By increasing or optimizing the thickness of the implant's cover section that separates the patient's skin and the front of the breast implant, the breast implant's visibility is reduced or eliminated. Figures 1A-1D show various views of the front, back, top, and bottom of a labeled breast implant. Increasing or optimizing the thickness of the cover section of the wrap covering the front of the breast implant, as described herein, also reduces or eliminates the appearance of dimpling or fine lines on the patient's skin due to the presence of the breast implant.

[0060] I. Definition

[0067] "Absorbable," as generally used herein, means that a material is broken down within the body and the breakdown 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 materials that are broken down and gradually absorbed, excreted, or eliminated by the body.

[0061]

[0068] As used herein, "average pore size diameter" is calculated using the open source ImageJ software available at https: / / imagej.nih.gov / ij / index.html.

[0062]

[0069] As used herein, "bioactive agent" is used to refer to a therapeutic, prophylactic, or diagnostic agent, preferably an agent that promotes healing and regeneration of host tissue, and also an agent that prevents, inhibits, or eliminates infection. "Drug, agent, agent" is intended to include a single such entity as well as a plurality of such entities.

[0063]

[0070] "Biocompatibility," as generally used herein, refers to a biological response to a material or device that is appropriate for the device's intended use in the body. Any metabolic products of these materials should also be biocompatible.

[0064]

[0071] "Blend," as generally used herein, means a physical combination of different polymers, as opposed to a copolymer formed from two or more different monomers.

[0065]

[0072] As used herein, "breast implant" refers to a prosthesis that can be implanted to change the size, shape, and contour of a woman's breast, as well as to replace the woman's breast.

[0066]

[0073] As used herein, "burst strength" is determined by test method ASTM D6797-02, "Standard test method for bursting strength of fabrics constant rate of extension (CRE) ball burst test," using an MTS Q-Test Elite universal testing machine or similar equipment. The test fixture uses a 3 / 8-inch diameter ball.

[0067]

[0074] As generally used herein, "copolymer of poly(butylene succinate)" refers to any polymer containing one or more different diol, diacid, or hydroxycarboxylic acid units, e.g., 1,4-butanediol and succinic acid units, with one or more carboxylic acid or hydroxycarboxylic acid groups. The copolymer may also contain chain extenders, coupling agents, crosslinking agents, or branching agents.

[0068]

[0075] "Copolymer of poly-4-hydroxybutyrate" as generally used herein means any polymer containing 4-hydroxybutyrate with one or more different hydroxy acid units.

[0069]

[0076] As used herein, "resilience" is measured as the percentage increase in area of ​​a test material when the area is deformed in ASTM burst method D6797-02 using a round ball.

[0070]

[0077] As used herein, "Elongation to break" means the increase in length of a material that occurs when tension is applied to break the material, expressed as a percentage of the original length of the material.

[0071]

[0078] As used herein, "Endotoxin unit" is determined using the Limulus amebocyte lysate (LAL) assay, as further described by Gorbet et al. Biomaterials, 26:6811-6817 (2005).

[0072]

[0079] "Lower pole" as generally used herein means the portion of the breast located between the inframammary fold (IMF) and the nipple meridian reference line and protruding from the chest wall.

[0073]

[0080] As used herein, a "macroporous" material or structure has an average pore size diameter of at least 25 microns, more preferably at least 50 microns, and even more preferably at least 75 microns.

[0074]

[0081] As used herein, "molecular weight" refers to weight average molecular weight (Mw) rather than number average molecular weight (Mn), unless otherwise specified, and is measured by GPC using polystyrene as a standard.

[0075]

[0082] The "Nipple meridian reference" or "NMR" is a plane drawn horizontally through the nipple and relative to the chest wall.

[0076]

[0083] "Oriented," as generally used herein, refers to the molecular alignment of polymer chains within a material. A drawn polymer can be partially oriented to highly oriented, with tensile strength increasing with increasing degrees of orientation. For example, unoriented polymer fibers can be drawn to orient the fibers, thereby resulting in polymer fibers with higher tensile strength. "Oriented mesh" means a mesh made of oriented fibers.

[0077]

[0084] "Poly-4-hydroxybutyrate," as generally used herein, refers to a homopolymer containing 4-hydroxybutyrate units, also referred to herein as Tepha's P4HB™ polymer or TephaFLEX® biomaterial (manufactured by Tepha, Inc., Lexington, MA).

[0078]

[0085] "Poly(butylene succinate)" as generally used herein means a polymer containing 1,4-butanediol units and succinic acid units.

[0079]

[0086] As used herein, "strength retention" refers to the amount of time a material maintains a particular mechanical property after implantation or exposure to a particular set of conditions. For example, if the stress required to break a multifilament yarn or monofilament fiber after one month is half of its original value, the multifilament or monofilament fiber is said to have 50% strength retention after one month.

[0080]

[0087] As used herein, "suture pull-out strength" refers to the peak load (kg) at which the breast implant fixation device cannot sustain the suture. It is determined using a tensile tester by securing the breast implant fixation device to a horizontal plate, threading a loop of suture through the breast implant fixation device at a distance of 1 cm from the edge of the device, and securing the suture arm to a fiber grip positioned above the breast implant fixation device. The test is performed at a crosshead rate of 100 mm / min, and the peak load (kg) is recorded. The suture is selected so that the breast implant fixation device breaks before the suture breaks. Suture pull-out strength can be converted and expressed in Newtons.

[0081]

[0088] "Tensile modulus" is the ratio of stress to strain for a given material within its proportionality limit.

[0082]

[0089] As used herein, "tissue expander" ("TE") refers to a breast implant that is temporarily placed within the breast to expand the tissue and make room for the breast implant. The TE is periodically expanded (e.g., inflated), for example, by injecting a liquid or gas into the TE. The TE is removed once the tissue has stretched sufficiently to make room for the permanent breast implant.

[0083]

[0090] "Upper pole" as generally used herein means the upper part of the breast located between the nipple meridian reference and the location of the crown of the breast, where the breast rises away from and away from the chest wall.

[0084] II. Materials for preparing wraps to limit breast implant movement

[0092] According to embodiments of the invention described herein, an implantable medical device, i.e., a breast implant fixation device, limits movement of the breast implant. In certain embodiments, the medical device is in the form of a wrap sized to surround the breast implant. In embodiments, the wrap is porous and is held in place by tissue ingrowth. The wrap remains at the implantation site and, in embodiments, limits movement of the breast implant by applying a compressive or frictional force to the breast implant. In embodiments, the wrap prevents the breast implant from rotating within the wrap. In embodiments, the wrap remains at the implantation site and prevents or limits movement of the breast implant, thereby preventing pocket stretching, lateral displacement of the breast implant, and ptosis. In embodiments, the wrap reduces capsular contraction around the breast implant.

[0085]

[0093] Referring to FIG. 2, an embodiment of a wrap (200) in accordance with the subject invention is shown. As further described herein, the wrap (200) is preferably porous and has a base section (210) for placement against a patient's chest wall and a cover section (220) for placement beneath the patient's skin. The wrap (200) preferably includes one or more tabs (230) that can be fastened to secure a breast implant within the wrap. In some embodiments, the tabs (230) can be fastened to the base section of the wrap by inserting them into slits (240) in the base section of the wrap. In some embodiments, the cover section (220) of the wrap has a thickness (t) sufficient to hide any fine lines or dimples in the patient's skin when the breast implant is placed in the base section (210) of the wrap, and the cover section (220) is placed over the breast implant, secured in place, and the wrap is placed within the patient's breast. The thickness (t) of the wrap is also preferably sufficient to prevent the breast implant from being easily noticeable. An exemplary range for the thickness (t) of the wrap cover section (220) is 0.5 to 10 mm, and more preferably 0.5 to 3 mm. In embodiments, the wrap cover section (220) has a thickness that is easily perceived and prevents the appearance of fine lines or indentations on the patient's skin, and the wrap cover section (220) is thicker than the wrap base section (210). The thickness (t) of the wrap cover section (220) can be uniform. In embodiments, the elasticity of the cover section (220) exceeds the elasticity of the base section (210).

[0086]

[0094] In an alternative embodiment, the wrap includes separate cover and base sections that the surgeon can assemble to form the device. The wrap can be assembled by placing the breast implant in the base section and then placing the cover section over the anterior portion of the breast implant, or vice versa. The cover and base sections can be joined to secure the breast implant within the wrap. The cover and base sections can further include connectors to join the cover and base sections. The cover section preferably has a three-dimensional shape designed to fit snugly over the anterior portion of the breast implant. The base section preferably has a two-dimensional shape, but may also have a substantially three-dimensional shape with a flat base and a concave perimeter. Tabs (230) can also be used to secure the wrap to the patient. The sections can further include one or more additional tabs for fastening the wrap to the patient's chest wall, or the surgeon can fasten the sections directly to the chest wall. Preferably, the base section can be fastened to the chest wall. The wrap preferably has pores sized to allow tissue ingrowth. In some embodiments, the resilience of the separate cover section exceeds the resilience of the separate base section of the device.

[0087]

[0095] However, in other embodiments, the thickness of the wrap or other mechanical properties described herein may vary along the cover section of the wrap from the area contacting the top side of the breast implant to the area contacting the bottom side of the breast implant (see FIG. 1B). For example, the thickness of the cover section of the wrap may decrease from the area contacting the top side of the breast implant to the area contacting the bottom side of the breast implant. The thickness of the area of ​​the cover section of the wrap contacting the top side of the breast implant may be 5 to 10 times greater than the area of ​​the cover section contacting the bottom side of the breast implant. Furthermore, in preferred embodiments, the thickness of the base of the wrap is thinner than the thickness of the cover section of the wrap.

[0088]

[0096] The elasticity may also vary along multiple regions of the wrap. In some embodiments, the wrap has a base section (210) for placement against the patient's chest wall and a cover section (220) for placement under the patient's skin, and the elasticity of the cover section (220) of the wrap is 15-75%, more preferably 30-65%, and the elasticity of the base section (210) of the wrap is 5-25%, more preferably 8-20%, when elasticity is measured as the percentage increase in the section when subjected to deformation using ASTM burst method D6797-02 using a round ball. In particularly preferred embodiments, the elasticity of the cover section (220) is 30-65%, and the elasticity of the base section (210) is 5-25%. In some embodiments, the elasticity of the cover section (220) is greater than the elasticity of the base section (210). The elasticity of the cover and base sections allows the wrap to tautly conform to the contours of the breast implant, facilitating easy encasement of the breast implant within the wrap. In some embodiments, the device (200) is adapted to tautly wrap around the entire implant, so that there are no gaps along the entire contour of the implant.

[0089]

[0097] In some embodiments, the wrap of the breast implant has different porosities in different regions of the wrap. The porosity of the base section (210) and the cover section (220) of the wrap may be different. The porosity of the cover section (220) may be different in the region located at the lower pole of the breast than in the region located at the upper pole of the breast.

[0090]

[0098] In some embodiments, the wrap has a larger average pore size diameter in the base section of the wrap (which is placed on the patient's chest wall) and a smaller average pore size diameter in the cover of the wrap (which is placed in front of the breast implant and between the breast implant and the patient's skin). The smaller average pore size in the cover of the wrap provides a larger surface area for retaining the fat graft. In some embodiments, the cover section (220) of the wrap is denser than the base section (210) of the wrap.

[0091]

[0099] In embodiments, the breast implant fixation device prevents migration of the breast implant by more than 5 cm, and even more preferably by more than 3 cm. In embodiments, the breast implant fixation device limits rotation of the wrapped breast implant by more than 45 degrees, and more preferably by more than 30 degrees. The wrap partially or completely covers the breast implant. Preferably, the breast implant is wrapped in the wrap prior to implantation. The wrap is preferably porous and allows for tissue ingrowth. The wrap is sized to accommodate the size and shape of the breast implant to be implanted. The size of the breast implant is selected by the surgeon according to the patient's needs and preferences.

[0092]

[0100] The wrap is preferably made of an absorbable polymer. Furthermore, the wrap can be made from a single component, such as unoriented, partially, or fully oriented monofilament fibers or multiple fibers, such as nonwoven, woven, and knitted mesh, or from two or more components, such as fibers, textiles, or films of different properties. The wrap can optionally contain a bioactive agent and cells, such as stem cells. The wrap preferably has a pyrogen level of less than 20 endotoxin activity units per device and can be sterilized.

[0093] A. Polymers for preparing wraps

[0102] The wrap may include, and more preferably is made entirely of, a degradable material. In a preferred embodiment, the device for securing the breast implant is made from one or more absorbable polymers, preferably absorbable thermoplastic polymers and copolymers.Implantable wraps may be made of, for example, polymers such as, but not limited to, polymers of glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, and succinic acid, e.g., polyglycolic acid, polylactic acid, polydioxanone, polycaprolactone, copolymers of glycolic acid and lactic acid, e.g., VICRYL® polymers, MAXON® polymers, and MONOCRYL® polymers, e.g., poly(lactide-co-caprolactone); poly(orthoesters); polyanhydrides; poly(phosphazenes); polyhydroxyalkanoates (PHAs); synthetic or biobased polymers. Chemically prepared polyesters; polycarbonates; tyrosine polycarbonates; polyamides (e.g., synthetic and natural polyamides, polypeptides, and poly(amino acids)); polyesteramides; poly(alkylene alkylates); polyethers (e.g., polyethylene glycol, PEG, and polyethylene oxide, PEO); polyvinylpyrrolidone or PVP; polyurethanes; polyetheresters; polyacetals; polycyanoacrylates; poly(oxyethylene) / poly(oxypropylene) copolymers; polyacetals, polyketals; polyphosphoric acids; (phosphorous acid-containing) polymers; polyphosphoesters; polyalkylene oxalates 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 polyvinylpyrrolidone (PVP), with blocks of other biocompatible or biodegradable polymers, e.g., poly(lactide), poly(lactide-co-glycolide), or polycaprolactone and its copolymers, e.g., their random and block copolymers. Preferably, the absorbable polymer or copolymer is substantially or completely resorbed within two years of implantation.

[0094]

[0103] Blends of polymers, preferably absorbable polymers, can also be used to prepare the wrap. Particularly preferred blends of absorbable polymers include, but are not limited to, polymers of glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, succinic acid, or copolymers thereof.

[0095]

[0104] In a particularly preferred embodiment, the wrap comprises poly-4-hydroxybutyrate (Tepha's P4HB™ polymer, Lexington, MA) or a copolymer thereof, and in one embodiment, is made entirely of P4HB or a copolymer thereof. Copolymers include P4HB with another hydroxy acid, such as 3-hydroxybutyrate, and P4HB with glycolic or lactic acid monomers. P4HB is a strong, flexible thermoplastic polyester that is biocompatible and resorbable (Williams, et al. Poly-4-hydroxybutyrate (P4HB): a new generation of resorbable medical devices for tissue repair and regeneration, Biomed. Tech. 58(5):439-452 (2013)). Upon implantation, P4HB hydrolyzes to its monomers, which are metabolized to carbon dioxide and water via the Krebs cycle. In a preferred embodiment, the weight average molecular weight Mw of the P4HB homopolymer and its copolymers is in the range of 50 kDa to 1,200 kDa (by GPC using polystyrene standards), more preferably 100 kDa to 600 kDa. Polymer weight average molecular weights of 50 kDa and above are preferred for processing and mechanical properties.

[0096]

[0105] In another preferred embodiment, the wrap comprises a polymer comprising at least a diol and a diacid. In a particularly preferred embodiment, the polymer used to prepare the wrap is poly(butylene succinate) (PBS), where the diol is 1,4-butanediol and the diacid is succinic acid. The poly(butylene succinate) polymer may be a copolymer comprising other diols, other diacids, or combinations thereof. For example, the polymer may be a poly(butylene succinate) copolymer further comprising one or more of the following: 1,3-propanediol, 2,3-butanediol, ethylene glycol, 1,5-pentanediol, glutaric acid, adipic acid, terephthalic acid, malonic acid, methylsuccinic acid, dimethylsuccinic acid, and oxalic acid. Examples of preferred copolymers are: poly(butylene succinate-co-adipate), poly(butylene succinate-co-terephthalate), poly(butylene succinate-co-butylene methyl succinate), poly(butylene succinate-co-butylene dimethyl succinate), poly(butylene succinate-co-ethylene succinate), and poly(butylene succinate-co-propylene succinate). The poly(butylene succinate) polymer or copolymer may also further comprise one or more of the following: chain extenders, coupling agents, crosslinking agents, and branching agents. For example, poly(butylene succinate) or copolymers thereof may be branched, chain-extended, or crosslinked by adding one or more of the following agents: malic acid, trimethylolpropane, trimesic acid, citric acid, glycerol propoxylate, and tartaric acid. A particularly preferred agent or agent for branching, chain-extending, or crosslinking poly(butylene succinate) polymers or copolymers thereof is a hydroxycarboxylic acid unit. Preferably, the hydroxycarboxylic acid unit has two carboxylic acid groups and one hydroxyl group, two hydroxyl groups and one carboxyl group, three carboxyl groups and one hydroxyl group, or two hydroxyl groups and two carboxyl groups.In one preferred embodiment, the wrap comprises poly(butylene succinate) containing malic acid as a branching, chain extender, or crosslinker. This polymer is referred to as poly(butylene succinate) crosslinked or chain extended with malic acid, succinic acid-1,4-butanediol-malic acid copolyester, or poly(1,4-butylene glycol-co-succinic acid) crosslinked or chain extended with malic acid. References to malic acid and other crosslinkers, coupling agents, branching agents, and chain extenders include polymers prepared with these agents, where the agents have undergone further reaction during processing. For example, the agents may have been dehydrated during polymerization. Thus, poly(butylene succinate)-malic acid copolymer refers to a copolymer prepared from succinic acid, 1,4-butanediol, and malic acid. In another preferred embodiment, malic acid can be used as a branching agent, chain extender, or crosslinker to prepare copolymers of poly(butylene succinate) and adipate, which can be referred to as malic acid crosslinked or chain extended poly[(butylene succinate)-co-adipate]. As used herein, "poly(butylene succinate) and copolymers" includes polymers and copolymers prepared with one or more of the following: chain extenders, coupling agents, crosslinkers, and branching agents. In a particularly preferred embodiment, poly(butylene succinate) and copolymers thereof contain at least 70%, more preferably 80%, and even more preferably 90% by weight of succinic acid and 1,4-butanediol units. Polymers comprising a diacid and a diol, such as poly(butylene succinate) and its copolymers, and others described herein, preferably have a weight average molecular weight (Mw) based on gel permeation chromatography (GPC) against polystyrene standards of 10,000 Da to 400,000 Da, more preferably 50,000 Da to 300,000 Da, and even more preferably 100,000 Da to 200,000 Da. In particularly preferred embodiments, the weight average molecular weight of the polymers and copolymers is 50,000 Da to 300,000 Da, and more preferably 75,000 Da to 300,000 Da.In one preferred embodiment, the poly(butylene succinate) or copolymers thereof used to make the wrap, or components of the wrap, have the following properties: density 1.23 to 1.26 g / cm. 3 It has one or more or all of a glass transition temperature of -31°C to -35°C, a melting point of 113°C to 117°C, a melt flow rate (MFR) of 2 to 10g / 10min at 190°C / 2.16kgf, and a tensile strength of 30 to 60MPa.

[0097] B. Additives

[0107] Some additives may be incorporated into the wrap, preferably into the absorbable polymer, copolymer, or blend thereof used to make the wrap. Preferably, these additives are incorporated during the compounding process to produce pellets that can then be melt processed. For example, the pellets can be extruded into fibers suitable for making the wrap. In another embodiment, the additives may be incorporated using a solution-based process, for example, fibers can be spun from a solution of the polymer and one or more additives. In a preferred embodiment, the additive is biocompatible, and even more preferably, the additive is both biocompatible and resorbable.

[0098]

[0108] In one embodiment, the additive may be a nucleating agent and / or a plasticizer. These additives may be added in a sufficient amount to produce the desired result. Generally, these additives may be added in an amount of 1% to 20% by weight. Nucleating agents may be incorporated to increase the crystallization rate of the polymer, copolymer, or blend. Such additives may be used, for example, to facilitate fabrication of the wrap and to improve the mechanical properties of the wrap. Preferred nucleating agents include, but are not limited to, salts of organic acids such as calcium citrate, polymers or oligomers of PHA polymers and copolymers, high melting point polymers such as PGA, talc, micronized mica, calcium carbonate, ammonium chloride, and aromatic amino acids such as tyrosine and phenylalanine.

[0099]

[0109] Plasticizers that may be incorporated into the composition to prepare the wrap include, but are not limited to, di-n-butyl maleate, methyl laurate, dibutyl fumarate, di(2-ethylhexyl)(dioctyl) maleate, paraffin, dodecanol, olive oil, soybean oil, polytetramethylene glycol, methyl oleate, n-propyl oleate, tetrahydrofurfuryl oleate, epoxidized linseed oil, 2-ethyl hexyl epoxytallate, glycerol triacetate, methyl linoleate, dibutyl fumarate, methyl acetyl ricinoleate, acetyl tri(n-butyl) citrate. Examples of suitable plasticizers include acetyl tri(n-butyl)citrate, acetyl triethyl citrate, tri(n-butyl)citrate, triethyl citrate, bis(2-hydroxyethyl)dimerate, butyl ricinoleate, glyceryl tri-(acetyl ricinoleate), methyl ricinoleate, n-butyl acetyl rincinoleate, propylene glycol ricinoleate, diethyl succinate, diisobutyl adipate, dimethyl azelate, di(n-hexyl)azelate, tri-butyl phosphate, and mixtures thereof. Particularly preferred plasticizers are citrate esters.

[0100] C. Bioactive Agents

[0111] The wrap can be loaded or coated with a bioactive agent. Bioactive agents can be included in the wrap for a variety of reasons. For example, bioactive agents can be included to improve tissue ingrowth into the wrap, to improve tissue maturation, to provide active agent delivery, to improve implant wettability, to prevent infection, and to improve cell attachment.

[0101]

[0112] The wrap may include a cell adhesion factor, e.g., a cell adhesion polypeptide. As used herein, the term "cell adhesion polypeptide" refers to a compound having at least two amino acids per molecule and capable of binding cells via cell surface molecules. Cell adhesion polypeptides include any of the proteins of the extracellular matrix known to play a role in cell adhesion, such as fibronectin, vitronectin, laminin, elastin, fibrinogen, collagen types I, II, and V, as well as synthetic peptides with similar cell adhesion properties. Cell adhesion polypeptides also include peptides derived from any of the above proteins, including fragments or sequences containing the binding domain.

[0102]

[0113] The wrap may incorporate a wetting agent designed to improve the wettability of the surface of the wrap so that fluids can be easily absorbed onto the wrap surface and to promote cell attachment and / or modify the water contact angle of the wrap surface. Examples of wetting agents include polymers of ethylene oxide and propylene oxide, such as polyethylene oxide, polypropylene oxide, or copolymers thereof, such as PLURONICS®. Other suitable wetting agents include surfactants or emulsifiers.

[0103]

[0114] The wrap may contain gels, hydrogels, or living hydrogel hybrids to further improve wettability throughout the thickness of the scaffold and to encourage cell growth. Hydrogel hybrids consist of living cells encapsulated within biocompatible hydrogels such as gelatin, silk gel, and hyaluronic acid (HA) gel.

[0104]

[0115] The wraps may contain active agents designed to stimulate cellular ingrowth, including growth factors, cell differentiation factors, cellular recruiting factors, cell receptors, cell binding factors, cell signaling molecules such as cytokines, and molecules that promote cell migration, cell division, cell proliferation, and extracellular matrix deposition. Such active agents include fibroblast growth factors (FGFs), transforming growth factors (TGFs), platelet-derived growth factors (PDGFs), epidermal growth factors (EGFs), granulocyte-macrophage colony-stimulating factors (GMCSFs), vascular endothelial growth factors (VEGFs), insulin-like growth factors (IGFs), hepatocyte growth factors (HGFs), interleukin-1B (IL-1B), interleukin-8 (IL-8), and nerve growth factors (NGFs), and combinations thereof.

[0105]

[0116] Other bioactive agents that can be incorporated into the wrap include antimicrobials, particularly antibiotics, bactericides, oncological agents, anti-scarring agents, anti-inflammatory agents, anesthetics, small molecule drugs, anti-angiogenic and pro-angiogenic factors, immunomodulators, and blood coagulants. Bioactive agents can be proteins, such as collagen and antibodies; peptides; polysaccharides, such as chitosan; alginic acid, hyaluronic acid, and their derivatives; nucleic acid molecules; small molecular weight compounds, such as steroids; inorganic materials, such as hydroxyapatite; or complex mixtures, such as platelet-rich plasma. Suitable antimicrobial agents include bacitracin, biguanides, triclosan, gentamicin, minocycline, rifampin, vancomycin, cephalosporins, copper, zinc, silver, and gold. Nucleic acid molecules can include DNA, RNA, siRNA, miRNA, antisense, or aptamers.

[0106]

[0117] The wraps may also include allograft and xenograft materials, such as acellular dermal matrix material and small intestinal submucosa (SIS).

[0107]

[0118] In yet another preferred embodiment, the wrap may incorporate a system for controlled release of a therapeutic or prophylactic agent.

[0108] D. Fiber

[0120] The wrap may include fibers. The fibers may preferably be made from a degradable thermoplastic polymer, even more preferably a degradable thermoplastic polyester. The fibers are preferably made from a degradable material listed in Section II.A above. In a preferred embodiment, the fibers are made from P4HB or a copolymer thereof. In another preferred embodiment, the fibers are made from poly(butylene succinate) or a copolymer thereof. The fibers may be monofilament fibers, multifilament fibers, or a combination thereof. The fibers may be twisted, untwisted, or substantially parallel strands. The fibers may be unoriented, partially oriented, highly oriented, or a combination thereof. Preferably, the fibers are highly oriented. The elongation at break value of the fibers may be 3% to 1,100%, more preferably 10% to 100%. The diameter of the fibers may range from 1 μm to 5 mm, more preferably 10 μm to 1 mm, and even more preferably 20 μm to 750 μm. The fibers in the wrap may have different weight average molecular weights. Preferably, the weight average molecular weight of the polymer in the fibers is between 10 kDa and 1,200 kDa, more preferably between 50 kDa and 600 kDa. The fibers in the wrap may have different tensile strengths. Preferably, the tensile strength of the fibers in the wrap is between 300 and 1,300 MPa. The fibers in the wrap are preferably flexible. Preferably, the tensile modulus of the fibers in the wrap is between 70 and 1,000 MPa, more preferably between 400 and 1,000 MPa. The fibers may have a short-term strength retention profile, a long-term strength retention profile, or a combination thereof. In one embodiment, the short-term strength retention profile is between 1 and 12 weeks, and the long-term strength retention profile is between 4 months and 5 years, more preferably between 4 months and 2 years. The fibers in the wrap may have different degradation rates in vivo. Some fibers may degrade rapidly, while other fibers may degrade slowly. In another embodiment, the fibers include additives or bioactive agents.The fibers can be produced by any suitable method, although melt extrusion or solvent spinning is preferred.In some embodiments, the breast implant fixation device has a base section and a cover section, and the average size of the fibers in the base section is larger than the average size of the fibers in the cover section.

[0109]

[0121] In a preferred embodiment, the fibers are made from P4HB monofilament fibers. Suitable P4HB monofilament filament fibers can be produced by melt extrusion using the following method: Bulk P4HB resin in pellet form is dried to less than 300 ppm moisture using a rotary vane vacuum pump system. The dried resin is conveyed to an extruder feed hopper with a nitrogen purge to keep the pellets dry. The pellets are gravity fed into a cooled feeder section and introduced into an extruder barrel equipped with a 1.50 inch (3.81 cm) diameter extruder screw with a 30:1 L / D ratio. The extruder barrel contains five heating zones (or extrusion zones)—Zones 1, 2, 3, 4, and 5. A suitable extruder is manufactured by American Kuhne. The heated and softened resin from the extruder is sent to a heated metering pump (melt pump), and from the melt pump, the extruded resin is sent to a heated block and an eight-hole spinneret assembly. Processing profiles are used that can range from temperatures of 40°C to 260°C and pressures of 400 psi to 2000 psi. The molten filament is water quenched and relaxed in-line before winding the monofilament onto a spool and conveyed into a three-stage orientation. Typical test values ​​for the extruded monofilament fiber are shown in Table 1.

[0110] [Table 1]

[0111]

[0123] In another preferred embodiment, the fibers are made from poly(butylene succinate) or copolymers thereof. Suitable monofilament fibers of poly(butylene succinate) or copolymers thereof can be produced by melt extrusion.

[0112]

[0124] Wraps capable of preventing rotation and migration of breast implants can be prepared from the fibers described above. Such wraps can be produced from slowly degrading and rapidly degrading fibers, degradable fibers of different molecular weights, unoriented, partially oriented, and fully oriented fibers, fibers with different elongation at break, tensile strength, and tensile modulus values, or combinations thereof.

[0113] E. Film

[0126] The wrap may comprise a film, more preferably a film that has been perforated to make it porous. The pores in the perforated film preferably have a diameter of 0.01 mm to 10 mm, more preferably 0.1 mm to 1 mm. In a particularly preferred embodiment, the perforated film has pores greater than 0.5 mm, even more preferably at least 0.8 mm. The pore density of the perforated film is preferably greater than 1 per square cm but less than 50 per square cm. The film is preferably made from a degradable thermoplastic resin, even more preferably a degradable polyester. The film is preferably made from a degradable material listed in Section II.A above. In a preferred embodiment, the film is made from P4HB or a copolymer thereof, or poly(butylene succinate) or a copolymer thereof. The weight-average molecular weight of the polymer in the film is preferably 10 kDa to 1,200 kDa, more preferably 50 kDa to 600 kDa. The film may be unoriented, partially oriented, uniaxially oriented, or biaxially oriented. The elongation at break of the film may be 3 to 1,100%, more preferably 15 to 300%. The film thickness is preferably 0.01 mm to 10 mm. The burst strength of the film, including the perforated film, is preferably 1 to 100 kgf. The film may have a short-term strength retention profile, a long-term strength retention profile, or a combination thereof. In one embodiment, the short-term strength retention profile is 1 to 12 weeks, and the long-term strength retention profile is 4 months to 5 years, more preferably 4 months to 2 years. The wrap film may have different degradation rates in vivo. Some films may degrade rapidly, while others may degrade slowly. In another embodiment, the film contains additives or bioactive agents. The film may be produced by any suitable method, such as melt extrusion, compression molding, injection molding, and solvent casting. In another embodiment, the film may be laminated or thermoformed.In one embodiment, the films are laminated together and then the laminated article is perforated and used to form a wrap. In several embodiments, the breast implant fixation device includes a base section and a cover section, where the base section includes a first film and the cover section includes a second film, and the elasticity of the second film exceeds the elasticity of the first film.

[0114]

[0127] Wraps that can prevent or limit migration and rotation of breast implants can be prepared from the films described above. Such wraps can be produced from slowly degrading and rapidly degrading films, films of different molecular weights, films with different degrees of orientation, films of different thicknesses, and films that are perforated, laminated, or thermoformed, or combinations thereof.

[0115] F. Foam

[0129] The wrap may comprise a foam. The foam is preferably made from a degradable thermoplastic polymer, even more preferably a degradable thermoplastic polyester. The foam is preferably made from a degradable material listed in Section II.A above. The foam may be made by any suitable method, such as melt foaming and solution foaming, such as particulate leaching. In a preferred embodiment, the foam is made from P4HB or a copolymer thereof or poly(butylene succinate) or a copolymer thereof. The foam may optionally be crosslinked. Preferably, the weight average molecular weight of the polymer in the foam is between 10 kDa and 1,200 kDa, more preferably between 50 kDa and 600 kDa. The foam may have an open-cell structure or a closed-cell structure. In one embodiment, the open-cell content of the foam is at least 10%, preferably at least 25%, and more preferably at least 50%. The cell size may be up to 5 mm. The density of the foam is preferably 1 g / cm 3 less than, more preferably 0.75 g / cm 3less than, even more preferably 0.5 g / cm 3 The foam thickness may be less than 0.01 mm to 10 mm. The foam may include an additive or a bioactive agent. The foam may have a short-term strength retention profile, a long-term strength retention profile, or a combination thereof. In one embodiment, the short-term strength retention profile is 1 to 12 weeks, and the long-term strength retention profile is 4 months to 5 years, more preferably 4 months to 2 years. In another embodiment, the foam includes an additive or a bioactive agent. In some embodiments, the breast implant fixation device includes a base section and a cover section, wherein the base section includes a first foam and the cover section includes a second foam, and the resiliency of the second foam exceeds the resiliency of the first foam.

[0116]

[0130] Wraps that can prevent or limit migration or rotation of breast implants can be prepared from the foams described above. Such wraps can be produced from foams with open or closed cell structures, with different cell sizes and densities, different molecular weights, and different strength retention profiles.

[0117] G. Textiles

[0132] The wrap may include a textile. The textile is preferably made from a degradable thermoplastic polymer, even more preferably a degradable thermoplastic polyester. The textile is preferably made from a degradable material listed in Section II.A above. In a preferred embodiment, the textile is made from P4HB or its copolymers, or poly(butylene succinate) and its copolymers.

[0118]

[0133] The thickness of the textile may be 0.01 mm to 10 mm. The average pore size diameter of the textile may preferably be 75 μm to 5 mm, more preferably 500 μm to 5 mm, and even more preferably 800 μm to 5 mm. Preferably, the weight average molecular weight of the polymers and fibers used to make the textile is 10 kDa to 1,200 kDa, more preferably 50 kDa to 600 kDa. The burst strength of the textile is preferably 0.1 kgf to 100 kgf, more preferably 1 kgf to 50 kgf. In embodiments, the elasticity of the textile may be 15 to 75%, 30 to 65%, 8 to 20%, or 5 to 25%, where elasticity is measured as the percentage increase in area of ​​the textile when the area is deformed using ASTM burst method D6797-02. The textile may have a short-term strength retention profile, a long-term strength retention profile, or a combination thereof. In one embodiment, the short-term strength retention profile is 1-12 weeks, and the long-term strength retention profile is 4 months-5 years, more preferably 4 months-2 years. The wrap may be formed from two or more textiles, and the textiles used to form the wrap may degrade at different rates. In some embodiments, the breast implant fixation device includes a base section and a cover section, wherein the base section includes a first textile and the cover section includes a second textile, and the elasticity of the second textile exceeds the elasticity of the first textile.

[0119]

[0134] The wraps may be formed from woven and knitted textiles or from nonwoven textiles.

[0120] Woven and knitted textiles

[0136] In one embodiment, the textile may be produced from monofilament fibers, multifilament fibers, yarns, or combinations thereof. The textile may be produced from the fibers described in Section II.D above. The fibers may be unoriented, partially oriented, highly oriented, or a combination thereof. The textile may be knitted, woven, or braided from the fibers. The textile may also be made from the fibers by crocheting. A particularly preferred textile for use in preparing the wrap is warp knit mesh. In embodiments, a textile having a thickness of 0.5 to 10 mm may be used to make the cover section (e.g., 220) of the wrap. In another embodiment, a textile having a thickness of 0.2 to 0.6 mm may be used to make the base section (e.g., 210) of the wrap. In another embodiment, a textile having an elasticity of 15-75% or 30-65% may be used to prepare the cover section (e.g., 220) of the wrap, and a textile having an elasticity of 5-25% or 8-20% may be used to prepare the base section (e.g., 210) of the wrap, where elasticity is measured as the percentage increase in area of ​​the section when the area is deformed using a round ball in ASTM burst method D6797-02. In embodiments, the elasticity of the textile used to prepare the cover section (e.g., 220) of the wrap exceeds the elasticity of the textile used to prepare the base section (e.g., 210) of the wrap.

[0121]

[0137] In other embodiments, the wraps (see Figures 1A and 1B, respectively) formed from the textile used to make the base section (e.g., 210) and the cover section (e.g., 220) surrounding the anterior top and anterior bottom regions of the breast implant have average pore sizes ranging from 0.5 to 3 mm, 0.5 to 1 mm, and 0.1 to 1 mm, with the region of the wrap surrounding the anterior bottom of the breast implant positioned at the lower pole closest to the patient's skin and the region of the wrap surrounding the anterior top of the breast implant positioned at the upper pole closest to the patient's skin.

[0122]

[0138] In a preferred embodiment, the textile is a mesh made of P4HB monofilament fibers or fibers comprising poly(butylene succinate) or a copolymer thereof. The P4HB monofilament fibers or fibers comprising poly(butylene succinate) or a copolymer thereof may be oriented. In a more preferred embodiment, the P4HB monofilament mesh or mesh comprising poly(butylene succinate) or a copolymer thereof has a knitted or woven structure, and even more preferably is a warp knit mesh. Particularly preferred P4HB monofilament mesh has substantially one or more of the following properties: an average pore size of 500 μm to 3 mm, a pore size of approximately 500 to 1,000 μm, a thickness of 0.2 to 10 mm, 0.2 to 5 mm, or 0.4 to 0.8 mm, and an areal density of 40 to 190 g / m. 2 or approximately 140-190g / m 2 , suture pull-out strength 1-7 kgf or 4-7 kgf, and burst strength 20-26 kg or 0.1-30 kgf / cm 2 Preferred meshes comprising poly(butylene succinate) or copolymers thereof have one or more of the following properties: (i) a suture pull-out strength of at least 10 N, 1 to 7 kgf, or at least 20 N; (ii) a burst strength of 0.1 to 100 kgf, more preferably 1 to 50 kgf, or greater than 0.1 kPa; (iii) a thickness of 0.5 to 10 mm, more preferably 0.05 to 5 mm; and (iv) an areal density of 5 to 800 g / m. 2(v) a pore size of 5 μm to 5 mm, or more preferably 100 μm to 1 mm, or (vi) an average pore size of 0.1 to 3 mm. Textiles comprising P4HB monofilament mesh or poly(butylene succinate) or its copolymers having a resilience of 15 to 75% or 30 to 65% can be used to prepare the cover section (e.g., 220) of the wrap, and textiles comprising these polymers having a resilience of 5 to 25% or 8 to 20% can be used to prepare the base section (e.g., 210) of the wrap, where resilience is measured as the percentage increase in the area of ​​the cover or base section when the area is deformed using a round ball in ASTM burst method D6797-02. In embodiments, the P4HB textile or poly(butylene succinate) textile used to prepare the cover section (e.g., 220) of the wrap has greater elasticity than the P4HB textile or poly(butylene succinate) textile used to prepare the base section (e.g., 210) of the wrap. More preferred meshes comprising poly(butylene succinate) or copolymers thereof have one or more of the following properties: (i) a suture pull-out strength of 1 kgf to 20 kgf or 1 to 7 kgf, (ii) a burst strength of 1 to 50 kgf, more preferably 5 to 30 kgf, and even more preferably 0.1 to 30 kgf / cm. 2 (iii) a thickness of 0.2 to 0.6 mm, 0.5 to 10 mm, or 0.1 to 1 mm; (iv) an areal density of 40 to 190 g / m 2 or 100-300g / m 2 and (v) a pore size of 100 μm to 1 mm. Even more preferred meshes comprising poly(butylene succinate) or copolymers thereof have one or more of the following properties: a pore size of 500±250 μm, a thickness of 0.4±0.3 mm, and an areal density of approximately 182±50 g / m. 2 , suture pull-out strength of 5.6±2 Kgf, and burst strength of at least 3 Kgf, more preferably at least 6 Kgf. A preferred textile comprising poly(butylene succinate) or a copolymer thereof is a monofilament knitted mesh, even more preferably a warp knitted monofilament mesh.

[0123]

[0139] A P4HB monofilament mesh suitable for preparing a wrap can be prepared according to the following procedure: P4HB monofilament fibers from 49 spools, prepared as described in Section II.D, are loaded onto a creel, aligned side-by-side, and pulled under uniform tension onto the top surface of a "contact" roll. The "contact" roll is rotated while semi-immersed in a bath filled with a 10% solution of TWEEN® 20 lubricant. The TWEEN® 20 lubricant is deposited on the surface of the sheet of fibers. After applying the TWEEN® 20, the sheet of fibers is passed through a comb guide and then wound onto a warp beam. The warp is a large, wide cylinder onto which individual fibers are wound side-by-side to provide the sheet of fibers. The warp beam is then converted into the finished mesh fabric by interlocking knit loops. Eight warp beams are mounted in parallel on the tricot knitting machine feedout and fed to the knitting elements at a constant speed determined by the "runner length." Each individual monofilament fiber from each beam is fed down through a series of dynamic tension elements to a knitting "guide." Each fiber is passed through a single guide, which is fixed to a guide bar. The guide bar directs the fiber around the needles, forming a mesh fabric structure. The mesh fabric is then removed from the needles by take-down rollers at a constant speed determined by the fabric's "quality." The mesh fabric is then picked up and wound onto a roll ready for scoring. P4HB monofilament mesh produced according to this method is ultrasonically scored with water, heat-set in hot water, and then washed in a 70% aqueous ethanol solution. A similar procedure can be used to prepare monofilament mesh of poly(butylene succinate) or its copolymers.

[0124] Nonwoven textiles

[0141] In another embodiment, textiles can be produced directly from the degradable materials listed in Section II.A. In one preferred embodiment, the textile has a nonwoven structure. More preferably, the nonwoven structure is dry-spun. Suitable methods for producing textiles directly from degradable materials, preferably thermoplastic polymers and thermoplastic polyesters, include meltblowing, electrospinning, centrifugal spinning, spunbonding, and solvent spinning, such as dry-spinning. Dry-spinning is a particularly preferred method for producing textiles. The textiles can include additives or bioactive agents. Dry-spun textiles have a nonwoven structure, similar to textiles produced by meltblowing, electrospinning, centrifugal spinning, spunbonding, and dry-spinning.

[0125]

[0142] In another preferred embodiment, a textile is nonwoven, preferably made from P4HB or poly(butylene succinate) or its copolymers by solution spinning (also known as dry spinning). Suitable dry-spun fibers of P4HB or poly(butylene succinate) or its copolymers can be produced by dissolving P4HB or poly(butylene succinate) or its copolymers in a solvent to form a polymer solution. Suitable solvents include chloroform, methylene chloride, acetone, and THF. A particularly suitable polymer solution for P4HB is an 8% w / v solution of P4HB in chloroform. The polymer solution can be transferred to a solvent reservoir connected to a nozzle directed toward a collector. Dry-spun fibers are collected when the polymer solution is injected or cast into a stream of accelerated gas exiting the nozzle. A suitable dry-spinning system has an inner nozzle and a concentric outer nozzle, which creates a low-pressure region near the orifice of the inner nozzle. A suitable gas is compressed air. The collector may be stationary, and the nozzle moved to form the nonwoven on the collector. However, more preferably, the collector may be rotated and moved in all directions to completely cover the collector with the dry-spun fibers and, if desired, to form a uniform coating of dry-spun fibers on the collector. Typically, however, the distance between the collector and the nozzle does not vary significantly. In one embodiment, the average diameter of the dry-spun fibers ranges from 0.01 μm to 50 μm. A particular benefit of solvent-spun P4HB fibers, as well as fibers of poly(butylene succinate) and its copolymers, rather than melt-spun, is that the weight-average molecular weight of the polymer decreases by no more than 10%, and even more preferably no more than 5%, during spinning.

[0126] Textile Compositions and Properties

[0144] Wraps capable of limiting or preventing migration or rotation of breast implants can be prepared from the woven, knitted, and nonwoven textiles described above. Such wraps can be produced from slowly and rapidly degrading textiles, woven and nonwoven textiles, knitted textiles, warp knit textiles, degradable textiles of different molecular weights, textiles made from unoriented, partially oriented, and fully oriented fibers, textiles made from monofilament fibers, multifilament fibers, yarns, and combinations thereof, textiles made directly from degradable materials, including by electrospinning, meltblowing, solvent spinning, including dry spinning, centrifugal spinning, and spunbonding, as well as textiles with different burst strengths, or combinations of the above.

[0127]

[0145] In one embodiment, the wrap comprises an auxetic structure, preferably an auxetic mesh.

[0128]

[0146] In one embodiment, a textile can include a bioactive agent. The bioactive agent can be coated on the textile, the bioactive agent can be contained in the textile, or a combination thereof. In a preferred embodiment, the bioactive agent is applied to the textile by spraying a solution of the bioactive agent onto the textile or by dip-coating the textile in a solution of the bioactive agent. In another preferred embodiment, a textile including the bioactive agent can be directly formed in one step. For example, a solution of a polymer and a bioactive agent can be solution spun, dry-spun, or electrospun to form a textile including the bioactive agent. In particularly preferred embodiments, the wrap may be formed from a P4HB textile or a textile of poly(butylene succinate) or copolymers thereof coated with one or more bioactive agents, or may be formed by forming a P4HB textile or a textile of poly(butylene succinate) or copolymers thereof containing one or more bioactive agents in a single step, for example, by melt or solution processing, dry spinning, solvent spinning, centrifugal spinning, spunbonding, meltblowing, melt spinning, or electrospinning. In a preferred embodiment, the textile used to form the wrap is a P4HB textile or a textile of poly(butylene succinate) or copolymers thereof containing one or more antibiotics.

[0129] III. Method of manufacturing a wrap to limit breast implant movement

[0148] Various methods can be used to manufacture breast implant fixation wrap devices, and several different examples of wraps for restricting migration and rotation of breast implants are described herein. The wrap restricts migration of the breast implant after it is encased in the wrap, and the wrap containing the breast implant is implanted into a patient. By restricting migration, it is meant that the wrap can be used to prevent migration of the breast implant a threshold distance after implantation. In embodiments, the threshold distance is 5 cm, and more preferably 3 cm or 1 cm. Preventing migration is important to prevent pocket stretching, ptosis, and lateral displacement of the breast implant. In other embodiments, the wrap restricts rotation of the breast implant after implantation in a patient. In embodiments, the wrap prevents the breast implant from rotating more than 45 degrees, and more preferably more than 30 degrees, after implantation.

[0130]

[0149] The wrap may have a two-dimensional shape that may be formed into a three-dimensional shape when the wrap is wrapped around the breast implant.

[0131]

[0150] In embodiments, the wrap is provided as a flexible, planar member and is pocket-free, pouch-free, and generally devoid of any kind of internal cavity or chamber for receiving a breast implant.

[0132]

[0151] In some embodiments, the wrap may have a three-dimensional shape. The wrap is preferably sized to at least partially cover and secure the breast implant. Preferably, the cover section of the wrap is designed to fit snugly over the anterior portion of the breast implant.

[0133]

[0152] In some embodiments, the base section is flat and the cover section has a 3D shape. In some embodiments, the cover can be made of a flexible material with a preset shape or shape memory to conform to the curvature of the top of the breast implant or the breast itself. A physician can select the sizing and curvature of the cover to fit the patient's anatomy or target patient anatomy. The fabrication and use of shape memory materials, including shaped full contour meshes, are described in various publications, including, for example, U.S. Patent Application Publication No. 20190247180, filed January 30, 2019, entitled "FULL CONTOUR BREAST IMPLANT," which is incorporated herein by reference in its entirety.

[0134]

[0153] The wrap is preferably made from a resorbable polymer, more preferably from a resorbable fiber, and even more preferably from a resorbable fiber that degrades in less than 5 years, more preferably in less than 2 years, and even more preferably in less than 1 year. The wrap can include fast and slow degrading fibers.

[0135]

[0154] The wrap may have a two-dimensional shape that may be formed into a dome shape, a rounded shape, a sphere, a three-dimensional shape, or an anatomical shape.

[0136]

[0155] Preferably, the wrap has minimal or no wrinkling when wrapped around the breast implant, hi embodiments, the device is free of wrinkles or creases after being wrapped around the breast implant.

[0137]

[0156] The volume enclosed by the wrap is preferably no more than 20% larger than the breast implant, more preferably no more than 10%, and even more preferably no more than 5% larger.

[0138]

[0157] In other embodiments, the wrap has elasticity that allows for a taut fit between the wrap and the breast implant. Preferably, the volume enclosed by the wrap is no more than 20% larger than the volume of the breast implant, more preferably no more than 10% larger than the volume of the breast implant, and even more preferably no more than 5% larger than the volume of the breast implant. Preferably, the volume enclosed by the wrap is between 150 and 800 cc, and more preferably between 165 and 800 cc.

[0139]

[0158] In another embodiment, the wrap is configured to form an unstretched volume that is slightly smaller (e.g., 5-10%) than the volume of the breast implant. When the breast implant is wrapped in the device, the device stretches to accommodate the entire contours of the breast implant, providing a snug fit and being substantially wrinkle-free.

[0140]

[0159] The wrap preferably has a shape that allows it to at least partially cover the breast implant without any unwanted protrusions that would interfere with implantation into the breast or detract from the final appearance of the breast.

[0141]

[0160] In some embodiments, the breast implant securement wrap device further includes one or more connectors that can be used to secure the breast implant within the wrap.

[0142]

[0161] In some embodiments, the breast implant securement wrap device further includes one or more tabs. The one or more tabs can be used to secure the wrap in place within the patient. For example, the tabs can be secured by suturing or stapling. The tabs are positioned on the opposite side of the wrap from the breast implant, more preferably on the opposite side of the wrap from the breast implant, at one or more locations around the circumference of the breast implant. In a preferred embodiment, the wrap includes a tab that is positioned superiorly when the wrap containing the breast implant is implanted into the breast. Wraps with tabs that can be secured superiorly to the patient, for example, to the pectoralis major muscle, can be used to maintain the vertical position of the breast implant, minimize implant movement, and prevent inferolateral instability. Any number of tabs, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12, can be incorporated into the wrap, but more preferably, four straps are incorporated, spaced 90 degrees apart from each other, around the circumference of the breast implant. Most preferably, the tabs are positioned on the wrap such that the tabs are positioned superiorly, inferiorly, centrally, and laterally relative to the breast implant when the wrap containing the breast implant is placed within the patient's breast.

[0143]

[0162] In embodiments, the breast implant securement wrap device is preferably shaped and sized to encase at least a portion, and more preferably all, of the breast implant. The size and shape of the wrap used in a procedure may be based on the surgeon's and patient's preferences for the size and shape of the breast implant and the need to closely match those requirements to the size and shape of the wrap so that the breast implant is at least partially covered by and secured within the wrap.

[0144]

[0163] Preferably, the wrap is porous or becomes porous after implantation, and even more preferably, the wrap is macroporous or becomes macroporous after implantation. In a preferred embodiment, the wrap comprises pores having an average pore size of at least 100 μm, more preferably at least 250 μm, and even more preferably at least 500 μm. A particularly preferred pore size is 800 μm±300 μm. A particularly preferred pore size is 0.64 mm 2 ±0.3mm 2 The wrap may be prepared from a porous material or from a non-porous material. In some embodiments, a wrap prepared from a non-porous material is then perforated.

[0145]

[0164] In embodiments, the material used to form the wrap has one or more of the following properties: (i) a burst strength of 0.1 to 30 Kgf / cm 2 (ii) suture pull-out strength of 1 to 7 kgf; and (iii) areal density of 40 to 190 g / m 2 In particularly preferred embodiments, the wrap material comprises poly-4-hydroxybutyrate or a copolymer thereof, or poly(butylene succinate) or a copolymer thereof, even more preferably in the form of a textile or other porous construction.

[0146]

[0165] The breast implant fixation wrap device may include additives listed in Section II.B and bioactive agents listed in Section II.C. The breast implant fixation wrap device may be coated with one or more of the following: bioactive agents, antibiotics, antimicrobial agents, autologous fat, fat lipoaspirate, injectable fat, adipocytes, fibroblasts, stem cells, collagen, and hyaluronic acid.

[0147]

[0166] The wrap produced preferably has an endotoxin content of less than 20 endotoxin activity units, making it suitable for implantation into a patient's body.

[0148]

[0167] Examples of breast implants that may be included in the wrap include silicone and saline breast implants, anatomical rounded breast implants, and surface textured and non-textured breast implants. Non-limiting examples of breast implants include: (i) Mentor's MemoryShape® breast implants, MemoryGel® breast implants, and Spectrum® breast implants; (ii) Allergan's Natrelle® breast implants, such as their rubbery breast implants, Inspira® responsive soft-touch and cohesive breast implants, Natrelle® 410 anatomical implants, Natrelle® saline-filled breast implants, and Biocell™ breast implants; (iii) Sientra's Opus™ breast implants, such as their smooth round, textured round, and textured shaped, high strength cohesive breast implants, HSC and HSC+; (iv) Arion Laboratories' Monobloc® silicone and hydrogel-CMC breast implants; (v) Cereplas Cereform® breast implants; (vi) Establishment Labs' Motiva® breast implants, such as their Ergonomix™ and Round breast implants; (vii) GC Aesthetics' Eurosilicone® and Nagor® breast implants, such as Impleo™, CoGEL™, Round Collection by Eurosilicone®, The Matrix by Eurosilicone®, GFX™ by Nagor®, and RGI™ by Nagor® breast implants; (viii) Groupe Sebbin's expansive, cohesive rounded, highly cohesive rounded, low anatomical and high anatomical breast implants; (ix) Guangzhou Wanhe Plastic Materials' Snow.(x) Hans Biomed's BellaGel breast implant; (xi) Ideal Implant Incorporated's Ideal Implant® breast implant; (xii) Polytech Health and Aesthetics' Mesmo®, Polytxt®, Microthane®, SublimeLine®, and DiagonGel® 4 Two breast implants; and (xiii) Silimed breast implants, including conical, rounded, and anatomical shapes. Additional examples of breast implants for use with embodiments of the subject invention are described in Maxwell and Gabriel, The evolution of breast implants, Plast. Reconstr. Surg. 134:125, No. 6,074,421 to Murphy, U.S. Pat. No. 5,007,929 to Quaid, U.S. Pat. No. 8,211,173 to Keller, U.S. Pat. No. 4,960,425 to Yan, U.S. Pat. No. 4,380,569 to Shaw, U.S. Pat. No. 5,902,335 to Snyder, U.S. Pat. No. 3,293,663 to Cronin, U.S. Pat. No. 4,863,470 to Carter, U.S. Pat. No. 4,773,909 to Chaglassian, U.S. Pat. No. 6,074,421 to Murphy, U.S. Pat. No. 8,377,127 to Schuessler, and U.S. Pat. No. 8,043,373 to Schuessler are referenced therein.

[0149] A. Wrap design example

[0169] In one preferred embodiment, a breast implant securement wrap device is designed to restrict movement of the breast implant using tabs on the cover section and slits in the base section to accommodate the tabs. A diagram of a wrap (200) with tabs on the cover section and slits in the base section to accommodate the tabs is shown in FIG. 2. The wrap may include a base section (210) suitable for wrapping around the back of the breast implant (see FIGS. 1A and 1B for the back and front locations of the breast implant, respectively). The base section (210) is shown having a circular or oval region. In some embodiments, the shape of the base section is sized to approximately fit the shape of the back of the breast implant. In some embodiments, the base section may have a non-circular shape.

[0150]

[0170] FIG. 2 also shows a cover section (220) suitable for encasing the front of a breast implant. Unlike the base section (210), the cover section (220) shown in FIG. 2 shows a plurality of extension members 260, each terminating in a tab (230), as further described herein. The extension members 260 are shown extending radially from the center of the cover (220). Adjacent extension members are defined or characterized by a gap, preferably a V-shaped cutout, as shown in FIG. 2. However, the cutout or gap may take other shapes, such as a U-shape, bowl, or step. As further described herein, the presence of the extensions and cutouts facilitates a taut, snug fit over the top of the breast implant and helps eliminate folds and wrinkles.

[0151]

[0171] A hinge section 250 joins the base section 210 and the cover section 220. The wrap 200 may be folded along the hinge section 250 so that the base section 210 and the cover section 220 can at least partially cover the breast implant. After placing the back of the breast implant on the base section 210 of the wrap 200, the cover section 220 may be secured in place by wrapping over the front of the breast implant and inserting the tabs 230 on the cover section 220 into the slits 240 in the base section 210. The shape of the wrap and the separate radial extensions are adapted to follow the contours of the breast implant when the back of the breast implant is placed on the base section 210 of the wrap 200 and the cover section 220 wraps over the front of the breast implant. Without being bound by theory, providing a cover that has a different geometry and properties than the base to which it is bonded serves to reduce wrinkles and creases on top of the breast implant after surgery.

[0152]

[0172] Figures 6-7 show bottom and top perspective views, respectively, of a breast implant wrap (600) arranged in a 3D configuration in accordance with an embodiment of the present invention. Tabs (610) on the cover section are shown extending from slits (620). In the embodiment shown in Figures 6-7, the tabs (610) serve to hold the wrap in place within the patient as well as connect the cover section and bottom section to one another.

[0153]

[0173] In alternative embodiments, tab 230 may be attached to base section 210 or to both the base and cover sections. Optionally, tab 230 may be secured to base section 210 after insertion into slit 240, for example, by stitching, heat bonding, or the use of adhesive.

[0154]

[0174] Optionally, although not shown, pleats or folds may be incorporated into one of the sections of the wrap instead of cutouts and are designed to minimize wrinkling of the wrap when used to cover a breast implant.

[0155]

[0175] The tabs (230) may also be used to secure the wrap to the patient's breast. In addition, the wrap (200) may further include one or more additional tabs to allow the wrap to be secured within the breast. Preferably, the wrap (200) includes tabs for securing to the patient, which may be superior when the wrap containing the breast implant is placed within the breast.

[0156]

[0176] In another preferred embodiment, the wrap is designed to limit movement of the breast implant using base sections that interlock to secure the breast implant within the wrap. A diagram of a wrap (300) with base sections that can be interlocked to encase the breast implant is shown in Figure 3. The wrap (300) includes a cover section (320) for wrapping over the front of the breast implant and eight base sections (310) connected to the cover section (320) by hinge regions (350). After placing the front of the breast implant in the cover section (320) of the wrap, the eight base sections (310) connected to the hinge regions (350) can be folded over the back of the breast implant and interlocked to secure the breast implant within the wrap (300). The wrap (300) is designed to minimize wrinkling of the wrap when the eight base sections (310) are interlocked to encase the breast implant. Optionally, the base section (310) may be secured, for example, by stitching, heat bonding, spot welding, or by using adhesive.

[0157]

[0177] The wrap (300) may further include one or more tabs (not shown) to secure the wrap within the breast. Preferably, the wrap (300) includes tabs for securing it to the patient, which may be superior when the wrap containing the breast implant is placed within the breast.

[0158]

[0178] In another embodiment, the breast implant securement wrap device is designed so that the back of the breast implant is only partially covered. This design allows the surgeon to pre-assemble the wrap prior to insertion of the breast implant. A view of the wrap (400) is shown in FIG. 4, showing the base of the breast implant not completely covered during use. The wrap includes a base section (410) that approximates a semicircle, as opposed to the full circle (210) shown in FIG. 2. The semicircular base section (410) is joined to the cover section (420) by a hinge region (450), as shown in FIG. 4. The cover section (420) includes a tab (430) that can engage within a slit (440) in the base section (410). The wrap (400) may be assembled pre-operatively, allowing the breast implant to be introduced after assembly of the device. Preferably, there is minimal wrinkling of the wrap (400) encasing the breast implant. The gaps (460) in the wrap (400) are designed to minimize wrinkling of the wrap when used to cover a breast implant. Optionally, the tabs (430) may be secured to the base section (410) after insertion into the slits (440), for example, by stitching, heat bonding, or using adhesive. The tabs (430) may also be used to secure the wrap to the patient. The wrap (400) may further include one or more additional tabs to enable the wrap to be secured within the breast. Preferably, the wrap (400) includes tabs for securing to the patient, which may be superior when the wrap containing the breast implant is placed within the breast.

[0159]

[0179] In a further embodiment, the breast implant securement wrap device includes a stretchable fabric, particularly in the cover section. Preferably, the stretchable fabric stretches less than 50% under a bidirectional burst load. A diagram of a wrap design in which the cover section includes a stretchable fabric is shown in FIG. 5. In contrast to the wrap (400) shown in FIG. 4, in which the cover section (420) has a design that minimizes wrinkle formation, the cover section (520) of the wrap (500) of FIG. 5 does not include gaps. Instead, the cover section (520) of the wrap (500) includes a stretchable fabric that does not wrinkle when the cover section is wrapped around a breast implant. Like the wrap (400), the wrap (500) may be assembled pre-operatively by placing the tabs (530) of the base section (510) into the slits (540) in the cover section, and then inserting the breast implant into the wrap. Alternatively, the back of the breast implant may be placed on the base section (510) of the wrap (500), the cover section (520) positioned over the front of the breast implant, and the tab (530) inserted into the slit (540) to secure the breast implant within the wrap. In either case, the tab (530) may be secured to the cover section (520) after insertion into the slit (540) by, for example, stitching, heat bonding, spot welding, or adhesive. The tab (530) may also be used to secure the wrap to the patient. The wrap (500) may further include one or more additional tabs to secure the wrap within the breast. Preferably, the wrap (500) includes tabs for securing it to the patient, which may be positioned superiorly when the wrap containing the breast implant is placed within the breast. In some embodiments, the wrap is formed so that the cover section (520) has greater elasticity than the base section (510).

[0160]

[0180] In another preferred embodiment, the wrap may include a base section and a separate cover section that is not connected to the base section. The separate base and cover sections may be fastened together to enclose the breast implant. The cover section preferably has a three-dimensional shape, more preferably shaped and sized to cover the anterior portion of the breast implant. The cover section is preferably shaped to contour to the anterior portion of the breast implant without wrinkles. The base section is preferably two-dimensional, but may also have a three-dimensional shape, where the periphery of the base section has a concave shape. The concave shape may be designed to surround the periphery of the breast implant and cover a portion of the bottom side (140) and top side (130) of the breast implant. The base section, the cover section, or both sections may further include one or more tabs to secure the breast implant inside the wrap. The wrap may also be assembled around the breast implant by stitching, glue, or heat bonding. Tabs may also be used to secure the wrap to the patient. The wrap may include one or more additional tabs to secure the device to the patient's chest wall.

[0161]

[0181] The wraps disclosed herein (e.g., but not limited to, 200, 300, 400, 500) are preferably designed so that the cover section of the wrap surrounds most, and even more preferably, all, of the protrusion of the breast implant from the patient's chest. In one embodiment, the wrap is designed to accommodate a protrusion of the breast implant from the chest wall ranging from 4 to 8.5 cm, and more preferably 4.2 to 7 cm.

[0162]

[0182] The wraps disclosed herein (for example, but not limited to, 200, 300, 400, 500) preferably have a base section ranging in width from 7.4 to 17.2 cm, and more preferably from 9 to 16.5 cm.

[0163]

[0183] The wraps disclosed herein may have a base section or cover section that includes one or more circular portions or sectors.

[0164]

[0184] The present invention encompasses a wide variety of mechanisms for attaching the cover section of the wrap to the base section of the wrap. Exemplary mechanisms for connecting the cover section to the base section and securing the breast implant therein include, but are not limited to, sutures, tabs, slits, snap fasteners, strings, buckles, straps, and cords, as well as the use of heat bonds, spot welds, or adhesives.

[0165] B. Wraps of different thicknesses, different pore sizes, and different elasticity

[0186] In further embodiments, the breast implant fixation wrap device can be prepared from one or more materials with different pore sizes, one or more materials with different elasticity, or one or more materials with different thicknesses, or combinations thereof. In one embodiment, suitably shaped materials with different pore sizes, different thicknesses, or both different pore sizes and different thicknesses can be joined, for example, by sewing, glueing, or welding, to form a wrap for the implant. In another embodiment, the wrap can be cut from sheets of different pore sizes, different thicknesses, or combinations thereof. The materials used to construct the wrap are preferably porous and, more preferably, textiles, such as woven, nonwoven, monofilament, multifilament, and knitted textiles. In a particularly preferred embodiment, the textile is a monofilament mesh, even more preferably a monofilament mesh with a Marlex knit pattern.

[0166]

[0187] Preferably, the cover section of the wrap (e.g., 220, 320, 420) (which is placed under the patient's skin) is 0.5-10 mm thick, and the base section of the wrap (e.g., 210, 310, 410) (which is placed next to the chest wall) is 0.2-0.6 mm thick. Wraps with thicker cover sections can avoid the formation of fine lines and dimpling in the patient's skin due to the presence of breast implants and reduce or eliminate the visibility of the breast implants. The use of wraps with thicker cover sections is particularly important in patients with thin skin or in patients where excess tissue has been removed, such as in a radical mastectomy procedure.

[0167]

[0188] In another embodiment, a wrap for securing a breast implant can be prepared with different pore sizes in different regions of the wrap. Preferably, the wrap is prepared with larger pores in the base section (e.g., 210, 310, 410) of the wrap (which will contact the chest wall after implantation) and smaller pores in the cover section (e.g., 220, 320, 420) that covers the upper side section of the breast implant (see FIG. 1B for the "upper side" location). The latter region will be located at the upper pole of the breast beneath the patient's skin after implantation. Larger pores in the base section of the wrap improve the drapeability of the wrap. Smaller pores on the cover section of the wrap that covers the upper side of the breast implant increase the surface area available for fat coating and allow more fat to be delivered to the upper pole of the breast. In a preferred embodiment, the average pore size in different regions of the wrap is: 0.5-3 mm in the base section of the wrap, 0.1-1 mm in the cover section of the wrap in the area covering the top side of the breast implant (see FIG. 1B for the top side location), and 0.5-1 mm in the cover section of the wrap in the area covering the bottom side of the breast implant (see FIG. 1A for the bottom side location).

[0168]

[0189] In certain embodiments, the wrap has an elasticity that allows for a taut fit and easy encasement of the breast implant. Preferably, the wrap is formed with a cover section of the wrap (e.g., 220, 320, 420, 520) (placed just beneath the patient's skin) having an elasticity of 15-75% or 30-65% and a base section of the wrap (e.g., 210, 310, 410, 510) (placed against the patient's chest wall) having an elasticity of 5-25% or 8-20%, where elasticity is measured as the percentage increase in area when the area is deformed using a round ball in ASTM burst method D6797-02. In particularly preferred embodiments, the wrap material may be selected so that the cover section of the wrap has an elasticity of 30-65% and the base section of the wrap has an elasticity of 8-20%.

[0169] C. Making a wrap

[0191] In embodiments, the wraps with tabs and slits (e.g., 200, 400, 500) or the wraps with interlocking sections (e.g., 300) can be formed using fiber-based structures, such as structures formed by meltblowing, solution spinning, dry spinning, electrospinning, centrifugal spinning, melt spinning, knitting, weaving, braiding, fiber entanglement, 3D printing, and fibers embedded in other structures such as foams, films, laminates, and fibers coated with films or foams. Fiber-based structures can include monofilament fibers, multifilament fibers, hollow fibers, and yarns. Fiber-based structures include nonwoven structures, knitted structures, braided structures, textiles, fabrics, and woven structures. Preferred fiber-based structures are (i) knitted monofilament meshes, and even more preferably knitted monofilament meshes comprising P4HB or its copolymers, or poly(butylene succinate) or its copolymers, and (ii) dry-spun nonwovens, and even more preferably P4HB dry-spun nonwovens or poly(butylene succinate) or its copolymers dry-spun nonwovens. In particularly preferred embodiments, wraps for breast implants are formed from knitted monofilament meshes comprising P4HB or its copolymers, or poly(butylene succinate) or its copolymers, or from meshes prepared as described in Section II.G above. The average fiber diameter of the monofilaments is preferably 0.04 mm to 0.35 mm, more preferably 0.05 to 0.2 mm. The wraps shown in Figures 2 and 3 can be prepared from a mesh of knitted monofilament fibers and cut to form the shapes shown in Figures 2 and 3. The knitted mesh can be cut, for example, with a sharp blade, scissors, or using a laser.

[0170]

[0192] In other embodiments, the cover section of the wrap (e.g., 220, 320, 420, 520) may be formed from a non-fiber-based structure, such as a film, laminate, or foam, or a structure including a combination of fiber, film, or foam. The cover section of the wrap may also be formed from a non-porous structure and later perforated.

[0171]

[0193] A breast implant fixation wrap device can be prepared, for example, using the following method steps: (i) preparing a monofilament knitted mesh, (ii) preparing a template, e.g., of the shape shown in Figures 2-5, (iii) placing the template on the knitted mesh, and (iv) cutting around the template to form the wrap. The mesh is ideally cut using a laser, but may also be cut using scissors, a die set, or a sharp blade. Preferably, the knitted mesh used in this method is a warp-knitted monofilament mesh, and even more preferably, a warp-knitted monofilament mesh comprising P4HB or a copolymer thereof, or comprising poly(butylene succinate) or a copolymer thereof. In further embodiments, tabs can be added to the wrap to secure the wrap to the patient. Alternatively, the template can be modified so that mesh tabs are formed when the wrap is cut from the mesh. Preferably, the mesh tabs are placed around the periphery of the base section of the wrap.

[0172]

[0194] Breast implant fixation wrap devices can also be prepared from nonwoven structures. The wrap can be prepared, for example, using the following method steps: (i) preparing a nonwoven structure, (ii) preparing a template, e.g., in the shape shown in Figures 2-5, (iii) placing the template over the nonwoven structure, and (iv) cutting around the template to form the wrap. A particularly preferred polymer for preparing the nonwoven wrap is P4HB or a copolymer thereof. Another particularly preferred polymer for preparing the nonwoven wrap is poly(butylene succinate) or a copolymer thereof. P4HB and poly(butylene succinate) or a copolymer thereof can be dry-spun to form a nonwoven without significant loss of weight average molecular weight. In a preferred embodiment, P4HB and poly(butylene succinate) or a copolymer thereof lose no more than 10% of their weight average molecular weight during dry-spinning the nonwoven.

[0173]

[0195] In another embodiment, a wrap for breast implant fixation is formed by 3D printing. Suitable methods for 3D printing the wrap include fused filament fabrication, fused pellet deposition, melt extrusion deposition, selective laser melting, slurry and solution printing using a coagulation bath, and printing using a binder solution and powder granules. Preferably, the wrap is 3D printed using P4HB or poly(butylene succinate) or copolymers thereof.

[0174]

[0196] In another embodiment, a wrap for breast implant fixation is formed by preparing a base section of the wrap (e.g., 220, 320, 420, 520) from a first mesh and a cover section of the wrap (e.g., 210, 310, 410, 510) from a second mesh, and ultrasonically or heat-sealing the two meshes together at a hinge. In some embodiments, the second mesh is more extensible than the first mesh. In some embodiments, the second mesh has higher elasticity than the first mesh. In some embodiments, the first and second meshes are knitted fibers, and the average diameter of the fibers used to knit the first mesh is larger than the average diameter of the fibers used to knit the second mesh. In some embodiments, the average diameter of the fibers used to knit the first mesh is 0.1 to 0.149 mm. In some embodiments, the average diameter of the fibers used to knit the second mesh is 0.07 to 0.099 mm. In some embodiments, the first mesh has a Marlex knit pattern. In some embodiments, the second mesh has a diamond knit pattern. In some embodiments, the base section (e.g., 210, 310, 410, 510) is formed with a Marlex mesh knit pattern made from fibers having an average diameter of 0.1-0.149 mm, and the cover section (e.g., 220, 320, 420, 520) is formed with a diamond knit pattern made from fibers having an average diameter of 0.07-0.099 mm.

[0175] IV. How to place the wrap containing the breast implant to limit movement

[0198] The wrap containing the breast implant may be implanted into the body. Preferably, the wrap assembly containing the breast implant is implanted into the breast. More preferably, the wrap is implanted into the breast where the patient is seeking breast reconstruction or augmentation surgery.

[0176]

[0199] The breast implant is preferably wrapped in or inserted into a wrap prior to implantation, although in some embodiments the wrap may also be implanted into the patient and the breast implant then placed within the wrap.

[0177]

[0200] In a preferred embodiment, the method includes providing a wrap in an initial flat or planar configuration, the flat or planar configuration including a base portion and a cover portion joined to the base portion at a hinge or joint, a breast implant is placed on the base portion, and the cover portion is folded over the breast implant.

[0178]

[0201] The cover is then pulled taut over the breast implant and secured to the base portion such that any wrinkles in the cover are removed.

[0179]

[0202] Optionally, one or more tabs of the cover can be pulled more taut toward the base to remove any creases or wrinkles present in the cover. In a preferred embodiment, and again referring to FIG. 2 , tabs (230) are inserted through slits (240) and can be pulled to secure the breast implant and remove any creases or wrinkles present in the cover. The use of tabs and slits serves to provide the physician with an implant-based mechanism for adjusting the fit of the cover to the implant and for adjusting (i.e., reducing) the number of creases or wrinkles on the cover. The implant is designed to provide a smooth surface covering the front of the breast implant so that indentations or fine lines are minimized or eliminated on the patient's breast skin surface. Tabs (230) are inserted and secured in slits (240) to allow the cover section (220) to cover the front of the breast implant without forming visible wrinkles on the surface of the breast. Optionally, the tabs may be fastened to secure the breast implant within the wrap, for example, by stitching, molding, welding, or using adhesive.

[0180]

[0203] In another preferred embodiment, the method includes providing a wrap comprising a cover section and a separate base section, wherein the breast implant is placed in the base section and the cover section is placed in front of the breast implant, or vice versa.

[0181]

[0204] The cover section and base section are then secured together such that any wrinkles on the cover section are removed.

[0182]

[0205] Optionally, the cover section and base section are secured together by one or more tabs present on one or more sections.

[0183]

[0206] In a preferred embodiment, the breast implant-containing wrap is used in breast reconstruction, particularly after mastectomy and breast augmentation surgery, such as mastopexy. The breast implant-containing wrap can be placed within a pocket formed in the breast entirely from the patient's tissue, or within a pocket formed using an implant, such as a pectoralis extender, such as acellular dermal matrix (ADM), P4HB mesh, mesh of poly(butylene succinate) or its copolymers, or other material that can form a hammock or sling within the breast. If desired, the pocket can be formed or enlarged using a tissue expander.

[0184]

[0207] In one embodiment, a procedure for implanting a breast implant-containing wrap following a mastectomy includes forming a pocket in the patient's breast suitable for receiving the breast implant-containing wrap and implanting the breast implant-containing wrap. In a preferred procedure for implanting a breast implant-containing wrap into a patient's body after a mastectomy, the method of implantation includes: (i) implanting a tissue expander into the patient's body; (ii) implanting a pectoral muscle augmenter adjacent to the tissue expander; (iii) expanding the tissue expander; (iv) removing the tissue expander; and (v) implanting the breast implant-containing wrap into the created pocket in the patient's breast. Preferably, the pectoral muscle augmenter is sutured to the detached pectoralis major muscle, which has been mobilized in preparation for placement of the tissue expander. The sutures may be permanent or absorbable, but are preferably absorbable. Once sutured to the pectoralis major muscle, the pectoral muscle augmenter can be used as a sling or hammock to cover the lower outer portion of the inserted tissue expander. The tissue expander may be partially expanded or unexpanded prior to implantation, in which case the tissue expander may be partially expanded immediately after implantation.

[0185]

[0208] In certain embodiments, the procedure for implanting a wrap containing a breast implant in a patient desiring breast augmentation surgery involves implanting the wrapped breast implant in a prepectoral (subglandular) position to eliminate the need to remove muscle from the chest wall and to reduce pain associated with removing muscle from the chest wall. However, in other embodiments, the wrap containing the breast implant may be implanted in a subpectoral or submuscular position, if desired.

[0186]

[0209] Preferably, the wrap encasing the breast implant can be secured in place. In some embodiments, the wrap includes one or more tabs or similar extensions that can be fastened to the patient's tissue. The tabs can be fastened to the patient's tissue using sutures, rivets, clips, staples, or similar fastening devices. In a particularly preferred implantation method, the wrap includes a superior tab that is positioned superiorly to the patient. The superior tab can be used to secure the wrap to the pectoralis major muscle to maintain the vertical position of the breast implant, prevent inferolateral instability, and minimize implant movement. Alternatively, the wrap can be secured in place by attaching the wrap directly to the patient's chest wall, for example, using sutures, rivets, staples, or other fastening devices and materials.

Claims

1. 1. A breast implant fixation device for securing a breast implant within a patient, comprising: a base section, a cover section, and a hinge region connecting the base section to the cover section Including, the implant fixation device having a substantially planar, two-dimensional first form; a folded three-dimensional second configuration, the cover section having a shape and size such that when the cover section is wrapped around a front portion of the breast implant and secured to the base section, the cover section at least partially covers the breast implant; and and A breast implant fixation device, wherein the cover section has a higher elasticity than the base section.

2. The device of claim 1 , wherein the cover section has an elasticity of 15 to 75%.

3. The device of claim 1 , wherein the base section has a resilience of 5 to 25%.

4. The device of claim 1 , wherein the base and cover sections include a plurality of pores.

5. The device of claim 4 , wherein an average diameter of the pores in the cover section is smaller than an average diameter of the pores in the base section.

6. 10. The device of claim 1, further comprising one or more tabs for fastening the device to the patient's chest wall to prevent movement of the breast implant.

7. The device of claim 1 , wherein the cover section has a thickness greater than a thickness of the base section.

8. 10. The device of claim 1, wherein the base section is formed from a first mesh and the cover section is formed from a second mesh, and the second mesh has a higher elasticity than the first mesh.

9. 9. The device of claim 8, wherein the first and second meshes are formed from fibers, and the average diameter of the fibers forming the first mesh is greater than the average diameter of the fibers forming the second mesh.

10. 10. The device of claim 1, further comprising a plurality of tabs and a plurality of slits, each slit adapted to receive one tab so that the cover can be tensioned to eliminate wrinkles in the cover.

11. 1. A breast implant fixation device for limiting movement of a breast implant within a patient, comprising: a two-dimensional first form including a base section, a cover section, and a hinge region connecting the base section to the cover section; a second three-dimensional configuration including a shape and size such that the cover section wraps around the front of the breast implant and at least partially covers the breast implant when secured to the base section; and At least one of the base section and the cover section includes a plurality of pores.

12. 12. The device of claim 11, wherein the base section is adapted to be placed in contact with a back portion of the breast implant and the cover section is adapted to fold over a front portion of the breast implant.

13. 12. The device of claim 11, further comprising another tab for fastening the device to the patient's chest wall to prevent movement of the breast implant.

14. 14. The device of claim 13, wherein at least one tab is positioned superiorly when the device is implanted in the breast.

15. 12. The device of claim 11, wherein the base or cover section further includes one or more tabs that can be used to secure the breast implant within the securement device.

16. 12. The device of claim 11, wherein the base or cover section further includes one or more slits or openings that can be used to secure the breast implant within the securement device.

17. The device of claim 11 , wherein the base or cover section comprises one or more circular portions or sectors.

18. 12. The device of claim 11, wherein the thickness of the cover section of the device is sufficient to prevent the breast implant from being easily perceived or to hide any fine lines or dimples in the patient's skin when the breast implant is encased within the device, and the device is implanted within the patient's breast with the base section positioned against the patient's chest wall and the cover section positioned under the patient's skin.

19. 12. The device of claim 11, wherein the cover section has an elasticity range selected from the group consisting of 15-75% and 30-65%, or the base section has an elasticity range selected from the group consisting of 5-25% or 8-20%.

20. 12. The device of claim 11, wherein when a breast implant is encased within the device and the device is implanted within a patient's breast, the elasticity of the cover section increases from an area contacting a top of the breast implant to an area contacting a bottom of the breast implant.

21. 12. The device of claim 11, wherein the device has one or more of the following thicknesses: a thickness of the cover section of the wrap between 0.5 and 10 mm, or a thickness of the base section of the wrap between 0.2 and 0.6 mm.

22. 12. The device of claim 11, wherein the thickness of the cover section is greater in the area that contacts the top of the breast implant than in the area that contacts the bottom of the breast implant, or optionally, the cover section has a preset shape or shape memory that conforms to the curvature of the top of the breast implant.

23. 12. The device of claim 11, wherein the device has one or more of the following pore sizes: an average pore size of 0.1 to 1 mm in the cover section of the device, and an average pore size of 0.5 to 3 mm in the base section of the device.

24. 12. The device of claim 11, wherein the device comprises one or more of the following: a textile, a woven textile, a nonwoven textile, a monofilament mesh, or a multifilament mesh.

25. The device has the following characteristics: (i) a burst strength of 0.1 to 30 kgf, measured using ASTM burst method D6797-02 with a 3 / 8 inch diameter round ball; (ii) a suture pull-out strength of 1 to 7 kgf; and (iii) an areal density of 40 to 190 g / m ２ 25. The device of claim 24, having at least one of the following properties:

26. The device of claim 11 , wherein the device is formed of a polymer, and optionally a resorbable polymer.

27. 27. The device of claim 26, wherein the device is formed of a resorbable polymer, and the resorbable polymer is poly-4-hydroxybutyrate or a copolymer thereof, or poly(butylene succinate) or a copolymer thereof.

28. 12. The device of claim 11, wherein the device further comprises one or more of the following: additives, bioactive agents, antibiotics, antimicrobial agents, autologous fat, lipoaspirate of fat, injectable fat, adipocytes, stem cells, collagen, and hyaluronic acid.

29. 12. The device of claim 11, wherein the endotoxin content of the device is less than 20 endotoxin activity units and the device is sterile.

30. 1. A method of making a breast implant fixation device for limiting movement of a breast implant within a patient's body, the method comprising: forming a two-dimensional wrap shaped and sized to at least partially cover the breast implant, the wrap including a base section, a cover section, and a hinge connecting the base section to the cover section.

31. 31. The method of claim 30, further comprising forming one or more tabs in the wrap that can be used to secure the breast implant within the securement device.

32. 31. The method of claim 30, further comprising forming the cover section with a greater thickness than the base section, forming the cover section with an average pore size less than the base section, forming the cover section with an elasticity of 15-75% and the base section with an elasticity of 5-25%, or forming the cover section with an elasticity different from the base section.

33. 12. A method of implanting a device as described in claim 11, comprising: selecting the wrap; placing a breast implant within the wrap; and placing the wrap containing the breast implant into position within the patient's breast.

34. 12. A method of implanting a device as described in claim 11, comprising providing the wrap; placing a breast implant on the base section and folding the cover section over the breast implant; and placing the wrap containing the breast implant into position within the patient's breast.

35. 35. The method of claim 34, further comprising pulling the cover section taut across the front of the breast implant to remove wrinkles.

36. a thin, sheet-like, two-dimensional first form, the first form further comprising a base section, a cover section, and a hinge region connecting the base section to the cover section; and a second three-dimensional configuration having a shape and size such that when the cover section is folded around the front of the breast implant and secured to the base section, the second three-dimensional configuration at least partially covers the breast implant. Including, breast implant wraps.

37. 37. The breast implant wrap of claim 36, wherein the cover section has a profile selected from the group consisting of: a star, a flower, and a gear.

38. 38. The breast implant wrap of claim 37, wherein the cover section has a central region and a plurality of extension members (or fingers, petals, or teeth) extending radially from the central region.

39. 39. The breast implant wrap of claim 38, wherein the number of extension members ranges from 4 to 8.

40. 37. The breast implant wrap of claim 36, wherein the base section has a profile selected from the group consisting of: a circle, a semicircle, a droplet, and an ellipse.

41. 1. A breast implant wrap for limiting movement of the breast implant within a patient, comprising: a thin, sheet-like, two-dimensional first form further including a cover section and a plurality of base sections extending radially from the cover section; a second three-dimensional form including a shape and size such that when each of the base sections is folded around the breast implant and secured together, the second three-dimensional form at least partially covers the breast implant; Including, breast implant wraps.

42. 42. The breast implant wrap of claim 41, wherein the first form has a profile selected from the group consisting of: a star, a flower, and a gear.

43. Any wrap for securing a breast implant as described herein.

44. Any method for encapsulating a breast implant as described herein and optionally implanting said encapsulated breast implant into said patient's body.

45. 1. A breast implant fixation device for limiting movement of a breast implant within a patient, comprising: A base section and a separate three-dimensional cover section Including; A breast implant fixation device, wherein the cover section includes a shape and size such that the cover section wraps around the front of the breast implant to enclose the breast implant and at least partially covers the breast implant when secured to the base section; and at least one of the base section and the cover section includes a plurality of pores.

46. 46. ​​The device of claim 45, wherein the base section has a two-dimensional shape or a three-dimensional shape with a concave shape around its periphery.

47. 46. ​​The device of claim 45, wherein the base section, cover section, or both sections have one or more tabs for securing the breast implant within the device.

48. 48. The device of claim 47, wherein the base section, the cover section, or both sections have one or more slits, each slit adapted to receive a tab, and the one or more tabs adapted to secure the device to the patient's chest wall.

49. 46. ​​The device of claim 45, wherein the thickness of the cover section is sufficient to prevent the breast implant from being easily perceived or to hide any fine lines or dimples in the patient's skin when the breast implant is secured within the device, and the device is implanted within the patient's breast with the base section positioned against the patient's chest wall and the cover section positioned underneath the patient's skin.

50. 46. ​​The device of claim 45, wherein the cover section has a higher resilience than the base section.

51. 51. The device of claim 50, wherein the cover section has an elasticity of 15 to 75%.

52. 1. A method of making a breast implant fixation device for limiting movement of a breast implant within a patient's body, comprising: forming a base section and a separate three-dimensional cover section; the cover section having a shape and size such that it at least partially covers the breast implant when the cover section is wrapped around the breast implant, and the cover section can be secured to the base section to surround the breast implant.

53. 53. The method of claim 52, further comprising forming one or more tabs in the base or cover section that can be used to secure the breast implant within the securement device.

54. 54. The method of claim 53, further comprising forming one or more slits, openings, or detents in the base or cover section sized to receive and / or interlock with the tabs of the opposing base or cover section to secure the breast implant within the securement device.

55. 55. The method of claim 54, wherein at least one of the tabs is used to secure the device within the patient.

56. 55. The method of claim 54, further comprising adjusting the tautness of the cover section by manipulating one or more of the tabs.

57. 1. A breast implant fixation device for securing a breast implant within a patient, the device comprising: a first section, a second section, and a hinge region connecting the first section to the second section; Including, the implant fixation device having a substantially planar, two-dimensional first form; a folded three-dimensional second configuration, the second section having a shape and size such that when the second section is wrapped around the anterior portion of the breast implant and secured to the first section, the second configuration at least partially covers the breast implant; and The second section has a greater resilience than the first section.

58. 1. A method of performing breast implant surgery, comprising: providing a wrap, said wrap being free of pockets and including a substantially planar first configuration; placing the breast implant in the base section of the wrap and folding the cover section over the front of the breast implant so that the wrap forms a 3D second configuration surrounding the breast implant; adjusting the tension of the cover over the top of the breast implant to eliminate wrinkles and creases throughout the breast implant; securing the cover to the base while the cover is stretched; and placing the wrap containing the breast implant in position within the patient's breast; A method comprising:

59. 59. The method of claim 58, wherein the securing step is performed by interlocking a plurality of radially extending teeth with a plurality of slits, each slit adapted to receive an individual tooth.

Images