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

Abstract

The invention relates to a breast implant wrap and related methods for limiting movement of a breast implant. Breast implant fixation devices for breast reconstruction and breast augmentation are described herein. The new wrap is designed to avoid lateral displacement and grounding of the breast implant, reduce balloon contraction and implant extrusion, eliminate skin dimples and ripples caused by the breast implant, and reduce or eliminate tactility. The wrap is adapted to be securely folded around the breast implant, restricting relative movement between the wrap and the breast implant, and reducing wrinkles. Inward growth of tissue into the wrap limits movement of the wrap-breast implant assembly and thereby limits movement of the breast implant.

Description

[0001] This application is a divisional application of Chinese patent application No. 202080093518.8, filed on November 16, 2020, entitled "Breast Implant Wrap and Related Method for Restricting Breast Implant Movement". Technical Field

[0002] This invention relates generally to the field of surgery, and more specifically, to an implantable medical device for restricting the movement of breast implants after breast reconstruction surgery, including augmentation mastopexy. Background Technology

[0003] Breast reconstruction after mastectomy has become an integral and important part of surgical breast cancer treatment, providing patients with both aesthetic and psychosocial benefits. Currently, nearly 65% ​​of breast reconstruction procedures in the United States utilize a tissue expander (TE), which is temporarily implanted into the breast in the first step of the procedure to create a pocket for the permanent breast implant. The tissue expander is now more frequently placed on top of the pectoral muscle (anterior placement) rather than under the pectoral muscle to reduce postoperative pain. Once the pocket is created, the TE is removed and replaced with a permanent breast implant in the second step. However, in some patients, a pocket for the breast implant can be created after mastectomy without the use of a TE.

[0004] Breast implants can also be used in breast augmentation and mastectomy procedures to increase breast size. In the latter, breast lift is combined with breast augmentation. Most commonly, the breast implant is placed in a pocket beneath the breast tissue, but in some cases, it is implanted under the chest wall.

[0005] Breast implants vary in size, shape, and surface texture. A wide range of sizes allows surgeons and patients to choose from a range of bulges, heights, widths, and total volumes. In terms of shape, there are round and anatomical implants, and the implant surface can be smooth, microtextured, or macrotextured. For example, the Siltex 1600 microtextured breast implant has a surface with small openings ranging from 70 to 150 µm in diameter and 40 to 100 µm in depth, while the Biocell RTV macrotextured breast implant has larger openings ranging from 600 to 800 µm in diameter and 150 to 200 µm in depth (Damino et al. Comparison of the capsular response to the Biocell RTV and Mentor 1600 Siltex breast implant surface texturing: a scanning electronmicroscopic study, Plastic and Reconstructive Surgery, 2001, 108(7), 2047-2052).

[0006] Texture of breast implants was initially used as a method to limit implant rotation and movement. However, recent studies using high-resolution ultrasound have found that large textures are insufficient to prevent 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 breast implant rotation rate of 27% in patients with anatomically shaped breast implants prepared by Mentor and Allergan. Furthermore, surprisingly, 26% of the examined implants rotated ≥45° from the midline. Sieber et al. concluded that implant rotation occurred in 42% of patients. Capsule formation around the breast implant may prevent it from being firmly secured in place.

[0007] Obviously, patients do not expect to find that their anatomical implants have rotated and that the thicker portion of the implant is no longer located at the bottom of the breast, but rather on the side or even at the top. This is especially true when the only way to resolve the issue is through further surgery.

[0008] Concerns about the use of anatomically shaped breast implants with large textures are not limited to undesirable rotation of the implant, which results in a suboptimal appearance of the breast. A growing body of evidence links the use of these implants to a significant increase in cases of potentially fatal anaplastic large cell lymphoma (ALCL), a rare 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 resulting from the large texture of anatomically shaped breast implants is considered a potential mechanism. Chronic inflammation is thought to trigger malignant transformation of T cells in certain circumstances, leading to cancers of the immune system. Treatment of lymphoma involves the removal of the implant and the surrounding cyst, and in more advanced cases, patients may require further treatment, including radiation therapy, chemotherapy, and lymph node dissection. Due to the increase in cases of breast implant-associated ALCL, the FDA has advised patients to investigate the risks associated with breast implants with large textured surfaces and smooth surfaces, and some surgeons are reducing or discontinuing their use of large textured breast implants.

[0009] Although rotation of a smooth breast implant does not necessarily alter the appearance of the breast, cases of ALCL (alternating fibrocystic breast implantation) have been reported, although the incidence is lower than in patients with anatomically shaped implants. Furthermore, a higher capsular contraction rate (resulting from the thickening of the initially thin, flexible capsule surrounding the implant) has been reported for smooth implants than for anatomically shaped implants (Damino, et al., Comparison of the capsular response to the Biocell RTV and Mentor 1600 Siltex breast implant surfacetexturing: a scanning electron microscopic study, Plast. Reconstr. Surg.2001, 108(7), 2047-2052). While the reasons for the higher capsular contraction rate are not fully understood, it has been hypothesized that it is due to the higher rotation rate and greater movement of smooth, round breast implants. Capsular contraction can be a serious problem and is relatively common. It can occur shortly after implantation or 20 to 30 years later. Capsular contraction that forms around the implant can cause chronic pain and a feeling of tightness around the breast. This can be treated with a capsulotomy, in which the implant is removed, an incision is made in the cyst, and the implant is replaced. Alternatively, cystic contracture can be treated with a capsulotomy, in which both the implant and the cyst are removed and a new implant is placed in the patient. Preferably, the need for these procedures should be avoided.

[0010] Aside from issues related to breast implant rotation, displacement of any type of breast implant is undesirable because it produces an unnatural breast appearance. Although undesirable, breast implant displacement is still not uncommon. In a study of 715 patients undergoing reconstruction, 71.5% required reoperation at year 10 due to implant displacement (O'Shaughnessy, 2015, Evolution and update on current devices for prosthetic breast reconstruction, Gland Surgery, 4(2):97-110). Breast implant displacement can occur if the pocket shape used for the implant is incorrect, and physical activity can also cause implant displacement. Implant displacement can also occur if the supporting tissue around the implant is stretched or thinned, or if there is a loss of tissue elasticity. These conditions can lead to, for example, “bottoming out,” where the implant shifts downward, resulting 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 cause lateral stretching of the implant pocket, causing the patient's breast implant to shift towards their side or armpit, especially when lying down.

[0011] Various implantable devices have been developed to create pockets for breast implants or to serve as slings in breast reconstruction. For example, acellular dermal matrix (ADM) 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 loosened and the ADM is attached to the edge of the muscle to create a sling and submuscular pocket for the tissue expander. The use of the ADM eliminates the need to release and elevate the serratus anterior muscle, pectoralis minor muscle, and rectus abdominis fascia, thus reducing postoperative pain. However, such devices are not designed to restrict rotation of the breast implant.

[0012] O'Keeffe's U.S. Patent No. 4,936,858 also discloses a pouch made of non-biodegradable yarn for use in breast implants. The pouch's diameter exceeds the implant's diameter by approximately 20%. The pouch is not designed to restrict rotation of the breast implant.

[0013] Benslimane's U.S. Patent No. 7,520,896 discloses a breast implant comprising: a support element (5) attached to the breast implant using an adhesive (4), and a fixation element (3) attached to the support element. The support element (5) can be attached to the patient's pectoral muscle or axillary region. Benslimane's Figure 5 A breast implant is shown comprising two packages designed to prevent microbial contamination of the implant: an outer package and an inner package. The outer package is non-sterile. However, the pouch is not designed to restrict any rotation or movement of the breast implant, and because the outer package is non-sterile, it is not designed for implantation.

[0014] Hunter's U.S. patent application No. 20070196421 discloses a sleeve for breast implants containing a fibrosis-inhibiting drug, but does not disclose a sleeve designed to restrict rotation of the breast implant.

[0015] Buevich’s U.S. Patent Application No. 20080128315 discloses a reabsorbable pouch for implantable medical devices, but does not disclose a pouch for breast implants or a pouch designed to restrict rotation of breast implants.

[0016] Wilson’s U.S. Patent Application No. 20020165596 discloses a reabsorbable pouch for placing bone grafts or bone graft replacements, but does not disclose a pouch for breast implants or a pouch designed to restrict rotation of breast implants.

[0017] Ledergerber's U.S. Patent No. 5,383,929 discloses a cover for implants that disrupts scar tissue at the implant / body interface. The cover is preferably made of expanded PTFE (a non-degradable polymer).

[0018] Mlodinow's WO2019 / 094861 discloses a mesh pouch for securing implants in a patient's body. The mesh pouch can be used to support breast implants.

[0019] 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 ADM to fix breast implants.

[0020] Despite the above, there remains a need for breast implant fixation devices, as described herein, that can limit the movement and rotation of breast implants and reduce capsular contraction. In particular, there is a need to develop breast implant fixation devices that can remove the anatomical structures dependent on the breast pocket to achieve the desired anatomical position of the breast implant. Such breast pockets can be highly variable and contradictory, especially after mastectomy, making it difficult to maintain proper vertical positioning and inferior stability of the breast implant. There is also a need to develop breast implant fixation devices that not only limit the movement of the breast implant but also prevent the implant from being palpable or conceal any ripples or dimpling in the breast caused by implantation. Such devices would provide improved aesthetic outcomes for patients. Another need exists for breast implant fixation devices that facilitate easier positioning and fixation of breast implants and minimize implant movement, migration, and gravitational effects on the implant. Summary of the Invention

[0021] This document describes a medical device for restricting breast implant movement. In some embodiments, the breast implant may be at least partially covered by a breast implant fixation device comprising a porous polymer two-dimensional encapsulation. The encapsulation can be anchored in the breast, thereby minimizing breast implant movement. The encapsulation may also include one or more tabs providing additional sites for securing the encapsulation in the breast. The encapsulation or tabs can be secured to the pectoralis major muscle and / or the patient's chest wall. The encapsulation or tabs may be sutured or stapled to secure and anchor the encapsulation in the patient's breast. The encapsulation also prevents the breast implant from being palpable, or prevents the formation of ripples or indentations on the skin after the breast implant has been placed in the breast. The encapsulation restricts breast implant movement by allowing tissue to grow inward into the encapsulation and by anchoring the encapsulation to the chest wall. The breast implant may be completely or partially encapsulated by the encapsulation. By providing a layer between the patient's skin and the breast implant, the encapsulation eliminates the problems of palpability or the formation of skin indentations and ripples.

[0022] Methods for preparing the encapsulation are also described. The encapsulation is preferably prepared using an absorbable polymer, most preferably using poly-4-hydroxybutyrate (P4HB) and its copolymers, or poly(butylene succinate) and its copolymers. The encapsulation is preferably prepared with porosity that allows tissue to grow inward and anchors the encapsulation at the implantation site. Preferably, the encapsulation is prepared using fibers, and most preferably using monofilament fibers or dry-spun fibers. Preferred methods for preparing the encapsulation include weaving and dry spinning.

[0023] Methods for using wraps containing breast implants in breast reconstruction and breast augmentation procedures (including augmentation mastectomy) are also disclosed. For example, the breast implant can be filled with silicone or saline. The wrap can be used after mastectomy and can be used in primary or secondary breast reconstruction procedures. In the latter case, a preferred method involves mobilizing the pectoralis major muscle, creating a submuscular pocket for a tissue expander (TE), optionally inflating the TE by attaching an acellular dermal matrix, P4HB textile, or a textile containing polybutylene succinate or copolymers thereof to the elevated pectoralis major muscle, removing the TE, and implanting the wrap containing the breast implant into the submuscular pocket.

[0024] During breast augmentation surgery, a package containing the breast implant can be placed in a breast pocket created in a subglandular location (above the pectoral muscle) or a submuscular location (below the pectoral muscle), but the former is preferred. When used for breast augmentation, the package and breast implant can be inserted via the axillary or umbilical approach, or after an areolar incision or an inframammary fold (IMF) incision.

[0025] A wrapping for breast implants to prevent movement within a patient comprises a base portion, a cover portion, and a hinge region connecting the base portion to the cover portion. Each of the base portion, the cover portion, and optionally the hinge region is made of a material containing multiple pores for inward tissue growth. The wrapping preferably includes one or more connectors for securing the breast implant within the wrapping.

[0026] Preferably, the package includes one or more tabs to provide additional sites for securing the package in the breast. More preferably, the package includes an upper tab. The upper tab can be used to secure the package to the pectoralis major muscle to maintain the vertical positioning of the breast implant, prevent underside instability, and minimize implant movement.

[0027] In some embodiments, the breast implant fixation device includes a package having a first substantially planar 2D configuration and a second 3D configuration when the breast implant is enclosed in the package.

[0028] In another embodiment, the breast implant fixation device includes a covering portion for placement between the breast implant and the patient's skin and a base portion for placement on the patient's chest wall.

[0029] In some embodiments, the breast implant fixation device includes a covering comprising a base portion, a covering portion, and a hinge region. The base portion, covering portion, and hinge region may form a two-dimensional single unit, which may be formed into a three-dimensional shape to at least partially cover the breast implant.

[0030] In some embodiments, the breast implant fixation device includes a cover containing a connector that secures the breast implant within the cover. The connector preferably connects a cover portion to a base portion.

[0031] In some embodiments, the breast implant fixation device includes a cover having a covering portion and a base portion, and may also include one or more fixation tabs. The fixation tabs may be positioned on the covering portion or the base portion. In some embodiments, the cover includes tabs for fixation, positioned high on the cover when the breast implant is at least partially covered by the cover and placed in the breast.

[0032] In an alternative embodiment, the breast implant fixation device comprises a base portion and a cover portion separate from each other. The device can be assembled to enclose the breast implant by placing the breast implant on the base portion of the device, placing the cover portion in front of the breast implant, and securing the base portion and cover portion together around the breast implant. More preferably, the cover portion has a three-dimensional shape formed to cover the front of the breast implant. Each of the base portion and the cover portion is made of a material containing a plurality of pores for inward tissue growth. The base portion, cover portion, or this portion may also include one or more connectors for securing the base portion and cover portion around the breast implant to form an enclosure.

[0033] In some embodiments, the breast implant fixation device includes a cover at least partially formed of one or more elastic materials, preferably wherein the covering portion of the cover has greater elasticity than the base portion of the cover. More preferably, when the breast implant is contained within the cover and placed in the breast, the elasticity of the covering portion of the cover increases from the area contacting the top of the breast implant to the area contacting the bottom of the breast implant. The elasticity of the cover facilitates its encapsulation of the breast implant and provides a tight configuration of the cover around the breast implant. The stretchability of the covering portion of the cover allows it to cover any protrusions of the breast implant.

[0034] In some embodiments, the breast implant fixation device includes a two-dimensional first configuration and a second three-dimensional configuration. The two-dimensional first configuration includes a base portion, a covering portion, and a hinge region connecting the base portion to the covering portion. The second three-dimensional configuration includes at least partially covering the shape and size of the breast implant when the covering portion surrounds the front portion of the breast implant and is secured to the base portion, wherein the elasticity of the covering portion is greater than that of the base portion. In some embodiments, the elasticity of the covering portion is 15% to 75%. In some embodiments, unless the elasticity of the covering portion is less than 25%, in which case the elasticity of the base portion should preferably be less than the elasticity of the covering portion, the elasticity of the base portion is at least 5% and less than 25%.

[0035] In some embodiments, the base portion and the cover portion include multiple holes. In some embodiments, the average diameter of the holes in the cover portion is smaller than the average diameter of the holes in the base portion.

[0036] In some implementations, the breast implant fixation device includes one or more flaps for securing the device to one of the patient's protrusions.

[0037] In some embodiments, the thickness of the covering portion of the device is greater than the thickness of the base portion of the device. In some embodiments, the base portion of the device is formed of a first mesh, and the covering portion is formed of a second mesh. In some embodiments, the elasticity of the second mesh is greater than the elasticity of the first mesh.

[0038] In some embodiments, the breast implant fixation device includes fibers in a base portion and a covering portion, and the average diameter of the fibers in the base portion is greater than the average diameter of the fibers in the covering portion.

[0039] In some implementations, the breast implant fixation device includes a cover having a covering portion and a base portion, wherein the covering portion of the cover is thicker than the base portion of the cover. When the cover containing the breast implant is placed in the breast, the covering portion is positioned between the patient's skin and the breast implant, minimizing the formation of ripples or indentations on the patient's skin and reducing the tactile presence of the breast implant.

[0040] In some implementations, the breast implant fixation device includes a wrapping made of textiles, woven textiles, knitted textiles, nonwoven textiles, monofilament meshes, multifilament meshes, or dry-spun textiles.

[0041] In another embodiment, the breast implant fixation device includes a package comprising a base portion for placement on the patient's chest wall, a bottom covering portion for placement on the anterior inferior pole of the breast, a top covering portion for placement on the anterior superior pole of the breast, and an intermediate covering area between the bottom and top covering portions for placement under the patient's skin; and the package is porous to allow tissue to grow inward and restrict movement of the breast implant.

[0042] In some embodiments, the breast implant fixation device includes a wrapping material, and the mechanical properties selected from porosity, thickness, and elasticity vary along the covered portion of the wrapping material from a region located at the upper pole of the breast to a region located at the lower pole of the breast.

[0043] In some embodiments, the breast implant fixation device includes a package, and the porosity of the package is adjusted to facilitate encapsulation of the breast implant within the package, particularly when the breast implant is circular. In some embodiments, the breast implant fixation device includes larger holes at the base of the package to provide a lower-density package that can hang more freely. In some embodiments, the breast implant fixation device includes smaller holes in the covering portion of the package to increase the surface area of ​​the covering portion relative to the base portion of the package, and to increase the surface area capable of supporting or being covered by fat.

[0044] In some implementations, the method includes the step of applying fat to the covered portion of the package, and in one specific implementation, autologous fat is applied to the anterior portion of the package or otherwise provided prior to implantation.

[0045] In some embodiments, the breast implant fixation device includes a wrapping that can be shaped around the breast implant to prevent movement of the breast implant, wherein the wrapping is adapted to engage the breast implant and prevent significant rotation of the breast implant within the wrapping; and wherein the wrapping also includes a plurality of outwardly extending (or protruding) anchors, wherein said anchors are characterized by a fibrous or filamentous structure, and optionally, wherein the anchor density is 10 to 50 anchors per square centimeter, and optionally, 20 to 30 anchors per square centimeter.

[0046] In some embodiments, the breast implant package for restricting movement of the breast implant in a patient comprises a sheet-like two-dimensional first configuration. The first configuration further includes a base portion, a covering portion, and a hinge region connecting the base portion to the covering portion. The package also includes a second three-dimensional configuration having a shape and size that at least partially covers the breast implant when the covering portion is folded around the front of the breast implant and secured to the base portion. In some embodiments, the covering portion has a profile selected from star-shaped, flower-shaped, and gear-shaped.

[0047] In view of the foregoing, one object of the present invention is to provide a medical device (e.g., a wrapping) for use with a breast implant that restricts the movement of the breast implant, including offset and rotation.

[0048] Another object of the present invention is to provide a breast implant fixation device that limits the displacement of the breast implant, prevents the breast implant from being tangible, and prevents the formation of any ripples or indentations when the breast implant is placed in the breast.

[0049] Another object of the present invention is to provide a breast implant fixation device that reduces capsular contraction.

[0050] Another object of the present invention is to provide a method for preparing or manufacturing a wrapping that restricts the movement of a breast implant.

[0051] Another object of the present invention is to provide a method for implanting a package and a breast implant.

[0052] These and other objects, aspects and advantages of the invention will become apparent from the following description with reference to the accompanying drawings. Attached Figure Description

[0053] Figure 1A , Figure 1B , Figure 1C and Figure 1D The rear view, front view, bottom perspective view, and in-situ side view of the breast implant (100) are shown, wherein the rear part (110) of the breast implant is placed on the patient's chest wall (150), and the front part (120) of the breast implant is placed directly under the patient's skin. The top side (130) of the breast implant is placed in the upper pole (160) of the breast, and the bottom side (140) of the breast implant is placed in the lower pole (170) of the breast.

[0054] Figure 2 A package (200) for a breast implant according to one embodiment of the present invention is shown, comprising a base portion (210) of the package, a cover portion (220) of the package, and a hinge (250) connecting the portions (210) and (220). The cover portion includes a tab (230) inserted into a slit (240) in the base portion (210) to secure the implant inside the package.

[0055] Figure 3 A package (300) for a breast implant according to one embodiment of the present invention is shown, comprising a cover portion (320) connected to eight base portions (310) via hinged portions (350). The base portions (310) are foldable around the breast implant and interconnected to secure the breast implant inside the package.

[0056] Figure 4A package (400) for a breast implant according to one embodiment of the present invention is shown, comprising a base portion (410) having a slit (440), a cover portion (420) having a tab (430), and a hinge (450) connecting the base portion (410) and the cover portion (420).

[0057] Figure 5 A package (500) for a breast implant according to an embodiment of the present invention is shown, comprising a base portion (510) having four tabs (530) and a cover portion (520) having four slits (540) and a hinge region (550) connecting the base portion (510) to the cover portion (520).

[0058] Figure 6 A bottom perspective view of a breast implant package (600) arranged in a 3D configuration according to an embodiment of the present invention is shown, wherein a portion of the package is transparent or removed to more clearly show features that would otherwise be hidden in the view.

[0059] Figure 7 It shows Figure 6 The front perspective view of the breast implant package (600) shown. Detailed Implementation

[0060] Before describing the invention in detail, it should be understood that the invention is not limited to the specific variations set forth herein, as various changes and modifications can be made to the described invention without departing from its spirit and scope, and equivalent solutions can be substituted. It will be apparent to those skilled in the art, upon reading this disclosure, that each individual embodiment described and illustrated herein has discrete components and features that can be readily separated from or combined with features of any of the other several embodiments without departing from the scope or spirit of the invention. Furthermore, numerous modifications can be made to adapt particular circumstances, materials, composition, processes, process behaviors, or steps to the purpose, spirit, or scope of the invention. All such modifications are intended to fall within the scope of the claims set forth herein.

[0061] The methods described herein can be performed in any logically possible order of the events described, as well as in the order in which the events are recorded. Furthermore, where a range of values ​​is provided, it should be understood that every intermediate value between the upper and lower limits of that range, as well as any other specified value or intermediate value within that range, is included within the scope of this invention. Additionally, any optional features of the invention contemplated for description may be set forth and claimed independently or in combination with any one or more of the features described herein.

[0062] All existing subjects mentioned herein (e.g., publications, patents, patent applications, and physical objects) are incorporated herein by reference in their entirety, except where such subjects may conflict with the subject matter of this invention (in which case the content presented herein shall prevail).

[0063] Nouns without quantifiers indicate one or more types. More specifically, unless the context clearly indicates otherwise, nouns without quantifiers used herein and in the appended claims indicate one or more types. It should be further noted that the claims may be drafted to exclude any optional elements. Similarly, this statement is intended to serve as a prior basis for the use of such exclusive terms, such as “merely,” “only,” etc., or the use of “negative” limiting terms, in connection with the recitation of elements of the claims. Finally, it should be understood that, unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0064] In some embodiments of the invention, the implantable medical device restricts the movement of the implanted breast implant, maintains the patient's physical appearance, reduces or eliminates the tactile presence of the breast implant, and lowers the chance of cyst contraction and the occurrence of breast implant-related lymphoma. Medical devices for preventing or limiting breast implant displacement and rotation can be prepared for use with various types of breast implants and for use in breast reconstruction procedures following mastectomy and breast augmentation procedures, including augmentation breast fixation procedures.

[0065] In some embodiments, the medical device is a package and is used by at least partially enclosing and securing a breast implant within the package. Preferably, the breast implant does not rotate more than 45 degrees within the package, and more preferably, it does not rotate more than 30 degrees. After securing the breast implant within the package, the package containing the breast implant is then implanted into the breast by a surgeon. Post-implantation, movement of the breast implant is prevented by tissue growth into the package, which anchors or secures the package and thus holds the breast implant in place. Preferably, the package is made of a synthetic polymer material to reduce the risk of disease transmission associated with implants of human or animal origin.

[0066] In some implementations, the medical device is a breast implant fixation device comprising a package, used by wrapping the package around the breast implant to at least partially cover it. The package is porous and allows tissue to grow inward. This inward tissue growth secures the package in place and prevents displacement of the breast implant. The perceptibility of the breast implant is reduced or eliminated by enhancing or optimizing the thickness of the implant coverage portion that separates the patient's skin from the anterior portion of the breast implant. Figures 1A to 1D Multiple views of a breast implant with marked front, back, top, and bottom sections are shown. The enhanced or optimized thickness of the wrapping covering the front of the breast implant, discussed in this article, also reduces or eliminates dimpling or ripples on the patient's skin due to the presence of the breast implant.

[0067] I. Definition

[0068] As used herein, “absorbable” generally means that a material degrades in the body and that the degradation products are eliminated or excreted from the body. The terms “absorbable,” “reabsorbable,” “degradable,” and “erosive,” with or without the prefix “bio,” are used interchangeably in this article to describe materials that are broken down by the body and gradually absorbed, excreted, or eliminated.

[0069] The "average aperture diameter" used in this article was calculated using the open-source ImageJ software available at https: / / imagej.nih.gov / ij / index.html.

[0070] As used herein, "bioactive agent" refers to a therapeutic, preventative, or diagnostic agent, preferably an agent that promotes the healing and regeneration of host tissues, and also preferably a therapeutic agent that prevents, inhibits, or eliminates infection. "Agent" without a quantifier includes one or more such "agents".

[0071] As is commonly used in this article, “biocompatibility” means that the biological response of a material or device is suitable for its intended in vivo application. Any metabolites of these materials should also be biocompatible.

[0072] The term “blend” as used in this article generally refers to a physical combination of different polymers, as opposed to a copolymer formed from two or more different monomers.

[0073] The term "breast implant" as used in this article refers to a prosthesis implanted in the location of a woman's breast, but it can also refer to a prosthesis implanted to alter the size, shape, and contour of a woman's breast.

[0074] The term "bursting strength" used in this article was determined using an MTSQ-Test Elite universal testing machine or similar apparatus according to test method ASTM D6797-02, "Standard Test Method for Bursting Strength of Fabrics at Constant Rate of Extension (CRE) Ball Bursting Test." A 3 / 8-inch diameter ball was used in the testing fixture.

[0075] As is commonly used in this document, “poly(butylene succinate) copolymer” means any polymer comprising 1,4-butanediol units having one or more distinct diol, diacid, or hydroxycarboxylic acid units (including hydroxycarboxylic acid groups having one or more carboxylic acid or hydroxy acid groups) and succinic acid units. The copolymer may also contain chain extenders, coupling agents, crosslinking agents, or branching agents.

[0076] As is commonly used in this article, “polymer of poly-4-hydroxybutyrate” means any polymer that contains 4-hydroxybutyrate having one or more different hydroxy acid units.

[0077] The term “elasticity” as used in this article is measured as the percentage increase in height of a region when deformation occurs in a region of the test specimen, as per ASTM Fracturing Method D6797-02 using a sphere.

[0078] As used in this article, "elongation at break" refers to the increase in the length of a material when a tension is applied that causes the material to break. It is expressed as a percentage of the original length of the material.

[0079] The term “endotoxin unit” as used in this article was determined using limulus amebocyte lysate (LAL) assays as further described by Gorbet et al. Biomaterials, 26:6811-6817 (2005).

[0080] In this article, the term "lower pole" generally refers to the portion of the breast that is located between the inframammary fold (IMF) and the nipple meridian reference and protrudes from the chest wall.

[0081] The “macropore” materials or structures used herein have an average pore diameter of at least 25 micrometers, more preferably at least 50 micrometers, and even more preferably at least 75 micrometers.

[0082] Unless otherwise stated, “molecular weight” as used herein refers to weight-average molecular weight (Mw), not number-average molecular weight (Mn), and is measured relative to polystyrene by GPC.

[0083] The “Nipple Meridian Reference” or “NMR” is a plane drawn horizontally through the nipple to the chest wall.

[0084] As used herein, “orientation” generally refers to the molecular arrangement of polymer chains in a material. Stretched polymers are partially oriented and subsequently highly oriented, and tensile strength increases with increasing orientation. For example, unoriented polymer fibers can be stretched to orient the fibers, resulting in polymer fibers with higher tensile strength. “Oriented network” refers to a network prepared from oriented fibers.

[0085] In this document, "poly-4-hydroxybutyrate" generally refers to a homopolymer containing 4-hydroxybutyrate units. It is referred to herein as Tepha's P4HB™ polymer or TephaFLEX. ® Biomaterials (manufactured by Tepha, Inc., Lexington, MA).

[0086] In this article, the term "poly(butylene succinate)" generally refers to a polymer containing 1,4-butanediol units and succinic acid units.

[0087] As used in this article, "strength retention" refers to the amount of time a material retains a particular mechanical property after being implanted or exposed to a specific set of conditions. For example, if the stress required to break a multifilament or monofilament fiber is half of its original value after one month, then the multifilament or monofilament fiber is said to have 50% strength retention after one month.

[0088] As used in this article, "suture pull-out strength" refers to the peak load (kg) that a breast implant fixation device fails to maintain on the suture. It is determined using a tensile testing machine by fixing the breast implant fixation device to a horizontal plate, passing the suture through a loop 1 cm from the edge of the breast implant fixation device, and securing the suture arm in a fiber grip positioned above the breast implant fixation device. Testing is performed at a crosshead rate of 100 mm / min, and the peak load (kg) is recorded. The suture is selected such that the breast implant fixation device fails before the suture fails. Suture pull-out strength is converted and expressed in Newtons.

[0089] "Tension modulus" is the ratio of stress to strain for a given material within its proportional limit.

[0090] As used in this article, a "tissue expander" ("TE") is a breast implant temporarily placed in the breast to expand tissue and make room for a breast implant. For example, the TE is periodically expanded (e.g., inflated) by injecting liquid or gas into it. Once the tissue has been sufficiently stretched to make room for a permanent breast implant, the TE is removed.

[0091] In this article, the term "upper pole" usually refers to the portion of the breast that protrudes from the chest wall and lies between the nipple meridian reference and the position of the top of the breast where the breast rises from the chest wall.

[0092] II. Materials used to prepare encapsulations that restrict movement of breast implants

[0093] According to embodiments of the invention described herein, an implantable medical device, namely a breast implant fixation device, restricts movement of a breast implant. In some embodiments, the medical device is sized to enclose the breast implant. In some embodiments, the enclosed package is porous and secured in place by inward tissue growth. The enclosed package is anchored at the implantation site and, in some embodiments, restricts movement of the breast implant by applying compressive or frictional forces to it. In some embodiments, the enclosed package prevents rotation of the breast implant within the package. In some embodiments, the enclosed package is anchored at the implantation site and prevents capillary stretching, lateral displacement, and sagging of the breast implant by preventing or limiting displacement of the breast implant. In some embodiments, the enclosed package reduces capillary contraction around the breast implant.

[0094] refer to Figure 2 An embodiment of the package (200) according to the invention is shown. As further described herein, the package (200) is preferably porous and has a base portion (210) for placement on the patient's chest wall and a covering portion (220) for placement under the patient's skin. The package (200) preferably includes one or more tabs (230) that can be fastened to secure a breast implant within the package. In some embodiments, the tabs (230) are fastened to the base portion of the package by inserting them into slits (240) in the base portion of the package. In some embodiments, when the breast implant is placed on the base portion (210) of the package and the covering portion (220) is placed over the breast implant, secured in place, and the package is placed in the patient's breast, the covering portion (220) of the package has a thickness (t) sufficient to conceal any ripples or dents in the patient's skin. The thickness (t) of the package is also preferably sufficient to prevent the breast implant from being palpable. The thickness (t) of the covering portion (220) of the package is exemplary in the range of 0.5 to 10 mm, and more preferably 0.5 to 3 mm. In some embodiments, the covering portion (220) of the package has a thickness that prevents tactile disturbance and ripples or indentations on the patient's skin, and the covering portion (220) of the package is thicker than the base portion (210) of the package. The thickness (t) of the covering portion (220) of the package may be uniform. In some embodiments, the elasticity of the covering portion (220) is greater than that of the base portion (210).

[0095] In an alternative embodiment, the package comprises separate covering and base portions that a surgeon can assemble to form a device. The package can be assembled by placing the breast implant on the base portion and subsequently placing the covering portion on the front of the breast implant, or vice versa. The covering and base portions can be joined together to secure the breast implant within the package. The covering and base portions may also include connectors that join the covering and base portions together. The covering portion preferably has a three-dimensional shape designed to mate above the front of the breast implant. The base portion preferably has a two-dimensional shape, but may also have a substantially three-dimensional shape with a flat base and a concave outer edge. A tab (230) may also be used to secure the package to the patient. The portion may also include one or more additional tabs to anchor the package to the patient's chest wall, or the surgeon may anchor the portion directly to the chest wall. Preferably, the base portion is anchored to the chest wall. The package preferably has openings sized to allow inward tissue growth. In some embodiments, the separate covering portion has greater elasticity than the separate base portion of the device.

[0096] However, in other embodiments, the thickness of the wrapping or other mechanical properties described herein vary along the covered portion of the wrapping from the area in contact with the top side of the breast implant to the area in contact with the bottom side of the breast implant (see [link to document]). Figure 1B For example, the thickness of the covering portion of the package may decrease from the area in contact with the top side of the breast implant to the area in contact with the bottom side of the breast implant. The area of ​​the covering portion of the package in contact with the top side of the breast implant may have a thickness 5 to 10 times greater than the area of ​​the covering portion in contact with the bottom side of the breast implant. Additionally, in a preferred embodiment, the base of the package has a thickness smaller than that of the covering portion.

[0097] The elasticity may also vary along the area of ​​the wrapping. In some embodiments, the wrapping has a base portion (210) for placement on the patient's chest wall and a cover portion (220) for placement under the patient's skin, and when elasticity is measured as the percentage increase in height of the portion when deformation occurs using ASTM Rupture Method D6797-02 with a sphere, the elasticity of the cover portion (220) is 15% to 75%, more preferably 30% to 65%, and the elasticity of the base portion (210) is 5% to 25%, more preferably 8% to 20%. In a particularly preferred embodiment, the elasticity of the cover portion (220) is 30% to 65%, and the elasticity of the base portion (210) is 5% to 25%. In some embodiments, the elasticity of the cover portion (220) is greater than that of the base portion (210). The elasticity of the cover portion and the base portion allows the breast implant to be easily wrapped in the wrapping, wherein the wrapping closely conforms to the contour of the breast implant. In some embodiments, the device (200) is adapted to tightly wrap around the entire implant so that there are no gaps along the entire contour of the implant.

[0098] In some embodiments, the package of the breast implant has different porosities in different regions of the package. The porosities of the base portion (210) and the covering portion (220) of the package can be different. The porosity of the covering portion (220) may differ in the region located at the lower pole of the breast from that in the region located at the upper pole of the breast.

[0099] In some embodiments, the package has a large average pore diameter at its base (which rests on the patient's chest wall) and a smaller average pore diameter at its covering (which rests in front of the breast implant and between the implant and the patient's skin). The smaller average pore diameter at the covering provides a larger surface area for holding the fat graft. In some embodiments, the covering (220) is denser than the base (210).

[0100] In some embodiments, the breast implant fixation device prevents the breast implant from shifting more than 5 cm, and even more preferably more than 3 cm. In some embodiments, the breast implant fixation device restricts the rotation of the encapsulated breast implant to more than 45 degrees, and more preferably more than 30 degrees. The encapsulation partially or completely covers the breast implant. Preferably, the breast implant is encapsulated with the encapsulation before implantation. The encapsulation is preferably porous and allows tissue to grow inward. The size of the encapsulation is customized to fit the size and shape of the implanted breast implant. The size of the breast implant is selected by the surgeon based on the patient's needs and preferences.

[0101] The encapsulation is preferably made of an absorbable polymer. Alternatively, the encapsulation may be made from a single component, such as unoriented, partially or fully oriented monofilaments or fibers, including nonwovens, fabrics, and woven meshes, or from two or more components, such as membranes, textiles, or fibers with different properties. The encapsulation may optionally contain bioactive agents and cells, including stem cells. The encapsulation preferably has a pyrogen level of less than 20 endotoxin units per device and may be sterilized.

[0102] A. Polymers used to prepare packaging

[0103] The encapsulation may contain biodegradable materials, and more preferably is made entirely of biodegradable materials. In a preferred embodiment, the device for securing the breast implant is made of one or more absorbable polymers, preferably absorbable thermoplastic polymers and copolymers. The implantable encapsulation may be made, for example, of polymers, including but not limited to polymers such as glycolic acid, lactic acid, and 1,4-dihydroxybenzoic acid. Alkyl ketones, trimethylene carbonates, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, and succinic acid, including polyglycolic acid, polylactic acid, and polydimethylethanol. Copolymers of ketones, polycaprolactone, glycolic acid, and lactic acid (e.g., VICRYL® polymers, MAXON®, and MONOCRYL® polymers), and including poly(lactide-co-caprolactone); poly(orthoesters); polyanhydrides; poly(phosphazenes); polyhydroxyalkanoates (PHAs); synthetic or bio-based polyesters; polycarbonates; tyrosine polycarbonates; polyamides (including synthetic and natural polyamides, peptides, and poly(amino acids)); polyamide esters; poly(alkylene alkylates); polyethers (e.g., polyethylene glycol, PEG, and polyethylene oxide). Poly(oxyethylene oxide, PEO); polyvinylpyrrolidone or PVP; polyurethane; polyether ester; polyacetal; polycyanoacrylate; poly(ethylene oxide) / poly(propylene oxide) copolymer; polyacetal, polyketal; polyphosphate / ester; (phosphorus-containing) polymer; polyphosphate ester; polyalkylene oxalate; polyalkylene succinate; poly(maleic acid); filament (including recombinant filament and filament derivatives and analogs); chitin; chitosan; modified chitosan; biocompatible polysaccharides; hydrophilic or water-soluble polymers (e.g., polyethylene glycol (PEG) or polyvinylpyrrolidone (PVP)), having blocks of other biocompatible or biodegradable polymers, such as poly(lactide), poly(lactide-co-glycolic acid), or polycaprolactone and their copolymers, including random copolymers and block copolymers thereof. Preferably, the absorbable polymer or copolymer will be substantially or completely absorbed two years after implantation.

[0104] Polymer blends, preferably blends of absorbable polymers, can also be used to prepare encapsulation materials. Particularly preferred blends of absorbable polymers include, but are not limited to, the following polymers: glycolic acid, lactic acid, 1,4-dihydroxyethyl glycolic acid, and hydroxyethyl glycolic acid. Alkyl ketone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, succinic acid, or copolymers thereof.

[0105] In a particularly preferred embodiment, the encapsulation comprises poly-4-hydroxybutyrate (Tepha's P4HB™ polymer, Lexington, MA) or a copolymer thereof, and in one embodiment may be prepared entirely from P4HB or a copolymer thereof. The copolymer comprises P4HB with another hydroxy acid, such as 3-hydroxybutyrate, and P4HB with glycolic acid or lactic acid monomers. P4HB is a robust, flexible thermoplastic polyester that is biocompatible and reabsorbable (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)). After implantation, P4HB hydrolyzes to its monomers, and the monomers are metabolized into 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 from 50 kDa to 1,200 kDa (by GPC relative to polystyrene), and more preferably from 100 kDa to 600 kDa. Polymers with a weight-average molecular weight of 50 kDa or higher are preferred for processing and mechanical properties.

[0106] In another preferred embodiment, the encapsulation comprises a polymer containing at least one diol and one diacid. In a particularly preferred embodiment, the polymer used to prepare the encapsulation is poly(butylene succinate) (PBS), wherein the diol is 1,4-butanediol and the diacid is succinic acid. The poly(butylene succinate) polymer can be a copolymer having other diols, other diacids, or combinations thereof. For example, the polymer can be a poly(butylene succinate) copolymer that also contains 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. Some 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 glycol succinate), and poly(butylene succinate-co-propylene glycol succinate). The poly(butylene succinate) polymer or copolymer may also include one or more of the following: chain extenders, coupling agents, crosslinking agents, and branching agents. For example, poly(butylene succinate) or its copolymers can 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. Particularly preferred reagents for branching, chain-extending, or crosslinking poly(butylene succinate) polymers or copolymers thereof are hydroxycarboxylic acid units. Preferably, the hydroxycarboxylic acid unit has two carboxyl 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 a preferred embodiment, the inclusion contains poly(butylene succinate) containing malic acid as a branching agent, chain extender, or crosslinking agent. The polymer may be 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-butanediol-co-succinic acid). It should be understood that references to malic acid and other crosslinking agents, coupling agents, branching agents, and chain extenders include polymers prepared with these reagents, wherein the reagents undergo further reactions during processing. For example, the reagents may undergo dehydration during polymerization. Therefore, poly(butylene succinate)-malic acid copolymers refer to copolymers 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 crosslinking agent for preparing copolymers of poly(butylene succinate) and adipate, which can be referred to as poly[(butylene succinate)-co-adipate] crosslinked or chain extended with malic acid.As used herein, “poly(butylene succinate) and copolymers” includes polymers and copolymers prepared using one or more of the following: chain extenders, coupling agents, crosslinking agents, and branching agents. In a particularly preferred embodiment, the poly(butylene succinate) and its copolymers comprise at least 70%, more preferably 80%, and even more preferably 90% by weight of succinic acid and 1,4-butanediol units. Based on gel permeation chromatography (GPC) relative to polystyrene standards, the weight-average molecular weight (Mw) of polymers comprising diacids and diols, including poly(butylene succinate) and its copolymers and other polymers described herein, is preferably from 10,000 Da to 400,000 Da, more preferably from 50,000 Da to 300,000 Da, and even more preferably from 100,000 Da to 200,000 Da. In a particularly preferred embodiment, the weight-average molecular weight of the polymers and copolymers is from 50,000 Da to 300,000 Da, and more preferably from 75,000 Da to 300,000 Da. In a preferred embodiment, the polybutylene succinate or its copolymer used to prepare the encapsulation or components thereof has one or more or all of the following properties: a density of 1.23 to 1.26 g / cm3, 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 10 g / 10 min at 190°C / 2.16 kgf, and a tensile strength of 30 to 60 MPa.

[0107] B. Additives

[0108] Certain additives may be incorporated into the encapsulation, preferably into the absorbable polymer, copolymer, or blend thereof used to prepare the encapsulation. Preferably, these additives are incorporated during the compounding process to produce granules that can subsequently be melt-processed. For example, the granules may be extruded into fibers suitable for preparing the encapsulation. In another embodiment, a solution-based method may be used to incorporate the additives; for example, the fibers may be spun from a solution of the polymer and one or more additives. In a preferred embodiment, the additives are biocompatible, and even more preferably, the additives are both biocompatible and reabsorbable.

[0109] In one embodiment, the additive may be a nucleating agent and / or a plasticizer. These additives may be added in sufficient quantities to produce the desired results. Generally, these additives may be added in amounts from 1% to 20% by weight. Nucleating agents may be incorporated to increase the crystallization rate of polymers, copolymers, or blends. Such agents can be used, for example, to facilitate the manufacture of encapsulated materials and to improve the mechanical properties of encapsulated materials. Preferred nucleating agents include, but are not limited to, organic acid salts (e.g., calcium citrate), polymers or oligomers of PHA polymers and copolymers, high-melting-point polymers (e.g., PGA), talc, micronized mica, calcium carbonate, ammonium chloride, and aromatic amino acids, such as tyrosine and phenylalanine.

[0110] Plasticizers that can be incorporated into compositions used to prepare packaging materials include, but are not limited to, dibutyl maleate, methyl laurate, dibutyl fumarate, di(2-ethylhexyl)(dioctyl)maleate, paraffin wax, dodecyl alcohol, olive oil, soybean oil, polytetramethylene glycol, methyl oleate, n-propyl oleate, tetrahydrofurfuryl oleate, epoxidized linseed oil, 2-ethylhexyl epoxy tall oleate, glyceryl triacetate, methyl linoleate, dibutyl fumarate, etc. Acetyl ricinoleate methyl ester, acetyl citrate tri(n-butyl) ester, acetyl citrate triethyl ester, tri(n-butyl) citrate, triethyl citrate, bis(2-hydroxyethyl) diemer, butyl ricinoleate, triglyceride tri(acetyl ricinoleate), methyl ricinoleate, acetyl ricinoleate n-butyl ester, propylene glycol ricinoleate, diethyl succinate, diisobutyl adipate, dimethyl azelaate, di(n-hexyl) azelaate, tributyl phosphate, and mixtures thereof. A particularly preferred plasticizer is citrate ester.

[0111] C. Bioactive agents

[0112] The encapsulation may be loaded with or coated with a bioactive agent. The bioactive agent may be included in the encapsulation for a variety of reasons. For example, the bioactive agent may be included to improve tissue inward growth into the encapsulation, to improve tissue maturation, to provide delivery of the active agent, to improve the wettability of the implant, to prevent infection, and to improve cell adhesion.

[0113] The encapsulation may contain cell adhesion factors, including cell adhesion peptides. As used herein, the term "cell adhesion peptide" refers to a compound having at least two amino acids per molecule that is capable of binding to cells via cell surface molecules. Cell adhesion peptides include any extracellular matrix protein known to play a role in cell adhesion, including fibronectin, porphyrin, laminin, elastin, fibrinogen, type I collagen, type II collagen, and type V collagen, as well as synthetic peptides with similar cell adhesion properties. Cell adhesion peptides also include peptides derived from any of the aforementioned proteins, including fragments or sequences containing binding domains.

[0114] Encapsulations may incorporate wetting agents designed to improve the wettability of the encapsulation surface, allowing fluids to readily adsorb onto the encapsulation surface and promoting cell adhesion and / or altering the water contact angle of the encapsulation surface. Some 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.

[0115] The encapsulation may contain gels, hydrogels, or active hydrogel hybrids to further improve wetting properties and promote cell growth throughout the scaffold thickness. Hydrogel hybrids consist of living cells encapsulated in biocompatible hydrogels such as gelatin, silk gels, and hyaluronic acid (HA) gels.

[0116] The encapsulation may contain active agents designed to stimulate inward cell growth, including growth factors, cell differentiation factors, cell recruitment 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 activators include fibroblast growth factor (FGF), transforming growth factor (TGF), platelet-derived growth factor (PDGF), epidermal growth factor (EGF), granulocyte-macrophage colony stimulation factor (GMCSF), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), hepatocyte growth factor (HGF), interleukin-1-B (IL-1B), interleukin-8 (IL-8), and nerve growth factor (NGF), as well as combinations thereof.

[0117] Other bioactive agents that can be incorporated into the packaging include antimicrobial agents, particularly antibiotics, disinfectants, oncology agents, anti-scarring agents, anti-inflammatory agents, anesthetics, small molecule drugs, anti-angiogenic and pro-angiogenic factors, immunomodulators, and coagulants. Bioactive agents can be proteins such as collagen and antibodies, peptides, polysaccharides such as chitosan, alginate, hyaluronic acid and its derivatives, nucleic acid molecules, low 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 molecules, or aptamers.

[0118] The package may also contain allogeneic and xenograft materials, including acellular dermal matrix materials and small intestinal submucosa (SIS).

[0119] In another preferred embodiment, the encapsulation may be incorporated into a system for controlling the release of therapeutic or preventative agents.

[0120] D. Fiber

[0121] The package may contain fibers. The fibers are preferably made from a degradable thermoplastic polymer, and even more preferably from a degradable thermoplastic polyester. The fibers are preferably made from the degradable materials listed in Section II.A above. In one preferred embodiment, the fibers are made from P4HB or copolymers thereof. In another preferred embodiment, the fibers are made from poly(butylene succinate) or copolymers thereof. The fibers may be monofilaments, multifilaments, or combinations thereof. The fibers may be twisted, untwisted, or substantially parallel ply yarns. The fibers may be unoriented, partially oriented, highly oriented, or combinations thereof. Preferably, the fibers are highly oriented. The elongation at break of the fibers may be from 3% to 1,100%, and more preferably from 10% to 100%. The diameter of the fibers may be from 1 μm to 5 mm, more preferably from 10 μm to 1 mm, and even more preferably from 20 μm to 750 μm. The fibers in the package may have different weight-average molecular weights. Preferably, the polymer of the fiber has a weight-average molecular weight of 10 kDa to 1,200 kDa, but more preferably 50 kDa to 600 kDa. The fibers in the encapsulation may have different tensile strengths. Preferably, the tensile strength of the fibers in the encapsulation is 300 to 1,300 MPa. The fibers in the encapsulation are preferably flexible. Preferably, the tensile modulus of the fibers in the encapsulation is 70 to 1,000 MPa, and more preferably 400 to 1,000 MPa. The fibers may have a short-term strength retention spectrum, a long-term strength retention spectrum, or a combination thereof. In one embodiment, the short-term strength retention spectrum is 1 to 12 weeks, while the long-term strength retention spectrum is 4 months to 5 years, more preferably 4 months to 2 years. The fibers in the encapsulation may have different degradation rates in vivo. Some fibers degrade rapidly, while others degrade slowly. In another embodiment, the fiber contains additives or bioactive agents. The fiber can be produced by any suitable method, but melt extrusion or solvent spinning is preferred. In some embodiments, the breast implant fixation device has a base portion and a cover portion, and the average size of the fibers in the base portion is larger than the average size of the fibers in the cover portion.

[0122] In a preferred embodiment, the fiber is prepared from P4HB monofilament fibers. Suitable P4HB monofilament fibers can be produced by melt extrusion using the following method: Bulk P4HB resin in granular form is dried to below 300 ppm water using a rotary vacuum pump system. The dried resin is transferred to an extruder feed hopper purged with nitrogen to keep the granules dry. The granules are gravity-fed into a cooled feeder section and introduced into an extruder barrel with a diameter of 1.50 inches (3.81 cm) and an extrusion 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 fed into a heated metering pump (melt pump), while the resin extruded from the melt pump is fed into a heating block and an eight-hole spinneret assembly. The treatment spectrum used ranged from 40°C to 260°C and from 400 psi to 2000 psi. The molten filaments were water-quenched and fed to a three-stage orientation process, followed by inline relaxation, and then the monofilaments were wound onto a spool. Typical test values ​​for the extruded monofilament fibers are shown in Table 1.

[0123] Table 1. Mechanical test data of P4HB monofilament fiber

[0124]

[0125] In another preferred embodiment, the fiber is prepared from poly(butylene succinate) or its copolymers. Suitable monofilament fibers of poly(butylene succinate) or its copolymers can be produced by melt extrusion.

[0126] Encapsulations that prevent rotation and displacement of breast implants can be prepared from the fibers described above. Such encapsulations can be produced from: slow- and fast-degrading fibers, biodegradable 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.

[0127] E. Membrane

[0128] The package may comprise a membrane, and more preferably, a membrane that has been perforated to make it porous. The pore size of the perforated membrane is preferably from 0.01 mm to 10 mm, and more preferably from 0.1 mm to 1 mm. In a particularly preferred embodiment, the perforated membrane has pores larger than 0.5 mm, and even more preferably at least 0.8 mm. The pore density of the perforated membrane is preferably greater than 1 / cm², but less than 50 / cm². The membrane is preferably made of a biodegradable thermoplastic, and even more preferably of a biodegradable polyester. The membrane is preferably made of the biodegradable materials listed in Section II.A above. In a preferred embodiment, the membrane is made of P4HB or a copolymer thereof, or of poly(butylene succinate) or a copolymer thereof. The weight-average molecular weight of the polymer in the membrane is preferably from 10 kDa to 1,200 kDa, but more preferably from 50 kDa to 600 kDa. The membrane can be unoriented, partially oriented, uniaxially oriented, or biaxially oriented. The elongation at break of the membrane can be from 3% to 1,100%, but more preferably from 15% to 300%. The thickness of the membrane is preferably from 0.01 mm to 10 mm. The burst strength of the membrane, including the perforated membrane, is preferably from 1 to 100 kgf. The membrane may have a short-term strength retention spectrum, a long-term strength retention spectrum, or a combination thereof. In one embodiment, the short-term strength retention spectrum is from 1 to 12 weeks, while the long-term strength retention spectrum is from 4 months to 5 years, more preferably from 4 months to 2 years. The membrane of the encapsulation may have different degradation rates in vivo. Some membranes degrade rapidly, while others degrade slowly. In another embodiment, the membrane contains additives or bioactive agents. The membrane can be produced by any suitable method, including melt extrusion, compression molding, injection molding, and solvent casting. In another embodiment, the membrane may be laminated or thermoformed. In one embodiment, the membrane may be laminated, and the laminate may then be perforated and used to form an encapsulation. In some embodiments, the breast implant fixation device includes a base portion and a cover portion, wherein the base portion includes a first membrane and the cover portion includes a second membrane, and the second membrane is more elastic than the first membrane.

[0129] Encapsulations that prevent or limit the displacement and rotation of breast implants can be prepared from the membranes described above. Such encapsulations can be produced from membranes that degrade slowly and rapidly, membranes of different molecular weights, membranes with different degrees of orientation, membranes of different thicknesses, and perforated, laminated, or thermoformed membranes or combinations thereof.

[0130] F. Foam

[0131] The encapsulation may comprise a foam. The foam is preferably prepared from a degradable thermoplastic polymer, and even more preferably from a degradable thermoplastic polyester. The foam is preferably prepared from the degradable materials listed in Section II.A above. The foam can be prepared by any suitable method, including melt foaming and solution foaming, including particle leaching. In a preferred embodiment, the foam is prepared from P4HB or a copolymer thereof, or poly(butylene succinate) or a copolymer thereof. The foam may optionally be crosslinked. Preferably, the polymer of the foam has a weight-average molecular weight of 10 kDa to 1,200 kDa, but more preferably 50 kDa to 600 kDa. The foam may have an open-cell or 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 less than 1 g / cm³. 3 More preferably less than 0.75 g / cm 3 And even more preferably less than 0.5 g / cm 3 The thickness of the foam can be from 0.01 mm to 10 mm. The foam may contain additives or bioactive agents. The foam may have a short-term strength retention spectrum, a long-term strength retention spectrum, or a combination thereof. In one embodiment, the short-term strength retention spectrum is 1 to 12 weeks, while the long-term strength retention spectrum is 4 months to 5 years, more preferably 4 months to 2 years. In another embodiment, the foam contains additives or bioactive agents. In some embodiments, the breast implant fixation device includes a base portion and a cover portion, wherein the base portion contains a first foam and the cover portion contains a second foam, and the elasticity of the second foam is greater than that of the first foam.

[0132] Encapsulations that prevent or limit the displacement or rotation of breast implants can be prepared from the foam-like materials described above. Such encapsulations can be prepared from foam-like materials having open or closed cell structures, different cell sizes and densities, different molecular weights, and different intensity retention spectra.

[0133] G. Textiles

[0134] The wrapping material may comprise textiles. The textiles are preferably made from degradable thermoplastic polymers, and even more preferably from degradable thermoplastic polyesters. The textiles are preferably made from the degradable materials listed in Section II.A above. In a preferred embodiment, the textiles are made from P4HB or copolymers thereof, or poly(butylene succinate) and copolymers thereof.

[0135] The thickness of the textile can be from 0.01 mm to 10 mm. The average pore diameter of the textile is preferably from 75 μm to 5 mm, but more preferably from 500 μm to 5 mm, and even more preferably from 800 μm to 5 mm. Preferably, the weight-average molecular weight of the polymer and fiber used to prepare the textile is from 10 kDa to 1,200 kDa, but more preferably from 50 kDa to 600 kDa. The bursting strength of the textile is preferably from 0.1 kgf to 100 kgf, but more preferably from 1 kgf to 50 kgf. In some embodiments, the elasticity of the textile can be from 15% to 75%, 30% to 65%, 8% to 20%, or 5% to 25%, wherein the elasticity is measured as the percentage increase in area when the textile area deforms in ASTM bursting method D6797-02. The textile may have a short-term strength retention spectrum, a long-term strength retention spectrum, or a combination thereof. In one embodiment, the short-term strength retention spectrum is from 1 to 12 weeks, while the long-term strength retention spectrum is from 4 months to 5 years, more preferably from 4 months to 2 years. The package may be formed from more than one type of textile, and the textiles used to form the package may degrade at different rates. In some embodiments, the breast implant fixation device includes a base portion and a cover portion, wherein the base portion includes a first textile and the cover portion includes a second textile, and the second textile is more elastic than the first textile.

[0136] The package may be made of woven and braided textiles, or it may be made of nonwoven textiles.

[0137] Woven and knitted textiles

[0138] In one embodiment, the textile may be produced from monofilament fibers, multifilament fibers, yarns, or combinations thereof. The textile may be produced from fibers described in Section II.D above. The fibers may be unoriented, partially oriented, highly oriented, or combinations thereof. The textile may be knitted, woven, or braided from fibers. The textile may also be prepared from fibers by crocheting. A particularly preferred textile for preparing wrappings is a warp-knitted mesh. In some embodiments, a textile with a thickness of 0.5 to 10 mm may be used to prepare the covering portion of the wrapping (e.g., 220). In another embodiment, a textile with a thickness of 0.2 to 0.6 mm may be used to prepare the base portion of the wrapping (e.g., 210). In another embodiment, a textile with an elasticity of 15% to 75% or 30% to 65% may be used to prepare the cover portion of the wrapping (e.g., 220), and a textile with an elasticity of 5% to 25% or 8% to 20% may be used to prepare the base portion of the wrapping (e.g., 210), wherein the elasticity is measured as the percentage increase in area when the area of ​​the portion deforms in ASTM Rupture Method D6797-02 using a sphere. In some embodiments, the elasticity of the textile used to prepare the cover portion of the wrapping (e.g., 220) is greater than the elasticity of the textile used to prepare the base portion of the wrapping (e.g., 210).

[0139] In other embodiments, the base portion (e.g., 210) and the covering portion (e.g., 220) surrounding the anterior top and anterior bottom regions of the breast implant are respectively defined. Figure 1A , 1B The average pore diameter of the wrapping formed by the textile is in the range of 0.5 to 3 mm, 0.5 to 1 mm and 0.1 to 1 mm, wherein the wrapping area around the anterior bottom of the breast implant is located at the lower pole closest to the patient's skin and the wrapping area around the anterior top of the breast implant is located at the upper pole closest to the patient's skin.

[0140] In a preferred embodiment, the textile is a mesh made of P4HB monofilament fibers or fibers containing poly(butylene succinate) or copolymers thereof. The P4HB monofilament fibers or fibers containing poly(butylene succinate) or copolymers thereof may be oriented. In a more preferred embodiment, the P4HB monofilament mesh or mesh containing poly(butylene succinate) or copolymers thereof has a knitted or woven structure, and even more preferably a warp-knitted mesh. Particularly preferred P4HB monofilament meshes substantially have one or more of the following characteristics: an average pore diameter of 500 μm to 3 mm, a pore diameter of about 500 to 1,000 μm, a thickness of 0.2 to 10 mm, 0.2 to 5 mm, or 0.4 mm to 0.8 mm, and an areal density of 40 to 190 g / m². 2 Or approximately 140 to 190 g / m2 The suture pull strength is 1 to 7 kgf or 4 to 7 kgf, and the burst strength is 20 to 26 kg or 0.1 to 30 kgf / cm². 2 Preferred meshes comprising poly(butylene succinate) or copolymers thereof have one or more of the following properties: (i) suture pull-out strength of at least 10 N, 1 to 7 kgf, or at least 20 N; (ii) burst strength of 0.1 to 100 kgf, more preferably 1 to 50 kgf, or greater than 0.1 kPa; (iii) thickness of 0.5 to 10 mm, more preferably 0.05 to 5 mm; and (iv) areal density of 5 to 800 g / m³. 2 (v) A pore size of 5 μm to 5 mm, or more preferably 100 μm to 1 mm, or (vi) an average pore diameter of 0.1 to 3 mm. Textiles containing P4HB monofilament mesh or poly(butylene succinate) or copolymers thereof with an elasticity of 15% to 75% or 30% to 65% can be used to prepare the cover portion of the wrapping (e.g., 220), and textiles containing these polymers with an elasticity of 5% to 25% or 8% to 20% can be used to prepare the base portion of the wrapping (e.g., 210), wherein elasticity is measured as the percentage increase in area when deformation occurs in the cover or base portion area using ASTM rupture method D6797-02 with the use of spheres. In some embodiments, the P4HB textile or poly(butylene succinate) textile used to prepare the cover portion (e.g., 220) of the wrapping has higher elasticity than the P4HB textile or poly(butylene succinate) textile used to prepare the base portion (e.g., 210) of the wrapping. More preferably, the mesh containing poly(butylene succinate) or its copolymers has 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) Thickness of 0.2 to 0.6 mm, 0.5 to 10 mm, or 0.1 to 1 mm; (iv) Areal density of 40 to 190 g / m³ 2 Or 100 to 300 g / m 2 and (v) pore diameter of 100 µm to 1 mm. Even more preferred networks comprising poly(butylene succinate) or copolymers thereof have one or more of the following properties: pore diameter of 500 ± 250 μm, thickness of 0.4 ± 0.3 mm, and areal density of about 182 ± 50 g / m³. 2The suture pull strength is 5.6 ± 2 kgf, and the burst strength is at least 3 kgf, more preferably at least 6 kgf. Preferred textiles containing poly(butylene succinate) or copolymers thereof are monofilament knitted meshes, and even more preferably warp-knitted monofilament meshes.

[0141] Suitable P4HB monofilament meshes for preparing wrapping materials can be prepared by mounting P4HB monofilament fibers from 49 spools, prepared as described in Section II.D, side-by-side aligned on a creel and pulled under uniform tension onto the upper surface of a "kiss" roller. The "kiss" roller is rotated while being partially immersed in a bath filled with a 10% TWEEN® 20 lubricant solution. TWEEN® 20 lubricant is deposited on the surface of the fiber sheet. After applying TWEEN® 20, the fiber sheet passes through a comb guide and is subsequently wound onto a warp beam. The warp yarns are large, wide cylinders on which single fibers are wound parallel to provide the fiber sheet. The warp beam is then converted into the finished mesh fabric by interlocking knitting loops. Eight warp beams are mounted parallel to each other on the tricot machine let-off and fed into the knitting element at a constant rate determined by the "runner length". Each single monofilament fiber from each beam is fed downwards into the knitting "guide" through a series of dynamic tension elements. Each fiber passes through a single guide bar fixed to a guide bar. The guide bar guides the fibers around the needle to form a mesh fabric structure. The mesh fabric is then pulled off the needle by a take-down roller at a constant rate determined by the fabric "quality". The mesh fabric is then picked up and wound onto the roller, ready for scoring. The P4HB monofilament mesh produced according to this method is ultrasonically scored with water, heat-set in hot water, and subsequently washed with a 70% aqueous ethanol solution. Similar operations can be used to prepare monofilament meshes of poly(butylene succinate) or its copolymers.

[0142] nonwoven textiles

[0143] In another embodiment, the textile may be directly produced from the biodegradable materials listed in Section II.A. In a preferred embodiment, the textile has a nonwoven structure. More preferably, the nonwoven structure is dry-spun. Suitable methods for directly producing textiles from biodegradable materials (preferably thermoplastic polymers and thermoplastic polyesters) include meltblowing, electrospinning, centrifugal spinning, spunbonding, and solvent spinning, including dry spinning. Dry spinning is a particularly preferred method for producing textiles. The textile may contain additives or bioactive agents. Dry-spun textiles have a nonwoven structure, as well as textiles produced by meltblowing, electrospinning, centrifugal spinning, spunbonding, and dry spinning.

[0144] In another preferred embodiment, the textile is a nonwoven fabric made of P4HB or poly(butylene succinate) or its copolymers, preferably prepared 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, dichloromethane, 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 aligned with a collector. The dry-spun fibers are collected when the polymer solution is injected or pumped into an accelerated gas flow exiting the nozzle. Suitable dry-spun equipment has an inner nozzle and a coaxial outer nozzle, which creates a low-pressure zone near the orifice of the inner nozzle. A suitable gas is compressed air. The collector can be stationary, and the nozzle moves to form a nonwoven fabric at the collector. However, more preferably, the collector can rotate and move in all directions to completely cover the collector with dry-spun fibers, and, if desired, to form a uniform coating of dry-spun fibers on the collector. However, generally, the distance between the collector and the nozzle does not vary significantly. In one embodiment, the average diameter of the dry-spun fibers is from 0.01 μm to 50 μm. A particular advantage of solvent-spun P4HB fibers and 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% during spinning, and even more preferably by no more than 5%.

[0145] Textile Compositions and Properties

[0146] Encapsulations that can limit or prevent displacement or rotation of breast implants can be prepared from the woven, knitted, and nonwoven textiles described above. Such encapsulations can be prepared from: slowly and rapidly degrading textiles, woven and nonwoven textiles, knitted textiles, warp-knitted textiles, biodegradable 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 from biodegradable materials including those directly prepared by electrospinning, meltblowing, solvent spinning including dry spinning, centrifugal spinning, and spunbonding, and textiles with different bursting strengths or combinations thereof.

[0147] In one embodiment, the package contains an auxetic structure, and preferably an auxetic mesh.

[0148] In one embodiment, the textile may contain a bioactive agent. The bioactive agent may be coated onto the textile, contained within the textile, or a combination thereof. In a preferred embodiment, the bioactive agent may be applied to the textile by spraying it with a bioactive agent solution or by immersing it in a bioactive agent solution. In another preferred embodiment, the textile containing the bioactive agent may be formed directly in a single step. For example, a solution of polymer and bioactive agent may be solution spun, dry spun, or electrospun to form a textile containing the bioactive agent. In a particularly preferred embodiment, the encapsulation may be formed from a P4HB textile coated with one or more bioactive agents or a textile of poly(butylene succinate) or its copolymers, or by forming a P4HB textile or a textile of poly(butylene succinate) or its copolymers containing one or more bioactive agents in a single step (e.g., by melt or solution treatment, dry spinning, solvent spinning, centrifugal spinning, spunbond, meltblowing, melt spinning, or electrospinning). In a preferred embodiment, the textile used to form the wrapping is a P4HB textile containing one or more antibiotics or a textile of poly(butylene succinate) or its copolymers.

[0149] III. Methods for preparing encapsulations to restrict the movement of breast implants

[0150] Various methods can be used to prepare breast implant fixation wrapping devices, and several different examples of wrappings that restrict breast implant displacement and rotation are described herein. After the breast implant is wrapped in the wrapping and the wrapping containing the breast implant is implanted into a patient, the wrapping restricts the displacement of the breast implant. Restricting displacement means that the wrapping can be used to prevent the breast implant from shifting off a threshold distance after implantation. In some embodiments, the threshold distance is 5 cm, and more preferably 3 cm or 1 cm. Preventing displacement is important for preventing pouch stretching, sagging, and lateral displacement of the breast implant. In other embodiments, the wrapping restricts the rotation of the breast implant after implantation in the patient. In some embodiments, the wrapping prevents the breast implant from rotating more than 45 degrees after implantation, and more preferably more than 30 degrees.

[0151] The package can have a two-dimensional shape, which can be formed into a three-dimensional shape when the package is wrapped around the breast implant.

[0152] In some implementations, the package is provided as a flexible planar member and is pouchless and unpouched, and typically lacks any type of cavity or chamber to receive the breast implant.

[0153] In some embodiments, the package may have a three-dimensional shape. The package is preferably sized such that it at least partially covers and secures the breast implant. Preferably, the covered portion of the package is designed to fit snugly against the front of the breast implant.

[0154] In some embodiments, the base portion is planar and the covering portion has a 3D shape. In some embodiments, the covering portion may be fabricated from a flexible material having a pre-defined memory or shape memory that matches the curvature of the top of the breast implant or the breast itself. Physicians can select the size and curvature of the covering portion to match the patient's anatomy or a target patient anatomy. The fabrication and use of shape memory materials, including shaped full-contour meshes, have been described in numerous publications, including, for example, U.S. Patent Publication No. 20190247180, filed January 30, 2019, entitled "FULL CONTOUR BREAST IMPLANT," which is incorporated herein by reference in its entirety for all purposes.

[0155] The encapsulation is preferably made of a reabsorbable polymer, more preferably of a reabsorbable fiber, and even more preferably of a reabsorbable 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 encapsulation may contain fibers with both rapid and slow degradation rates.

[0156] The package can have a two-dimensional shape, and it can be formed into a dome shape, a circle, a sphere, a three-dimensional shape, or an anatomical shape.

[0157] Preferably, the wrapping material wrinkles minimally or not at all when it is wrapped around the breast implant. In some embodiments, the device is wrinkle-free or crease-free after being wrapped around the breast implant.

[0158] The volume enclosed by the covering is preferably no more than 20% larger than the breast implant, more preferably no more than 10% larger, and even more preferably no more than 5% larger.

[0159] In other embodiments, the package has elasticity that allows for a tight fit between the package and the breast implant. Preferably, the volume enclosed by the package is no more than 20% larger than the volume of the breast implant, more preferably no more than 10% larger, and even more preferably no more than 5% larger. Preferably, the volume enclosed by the package is 150 to 800 cc, and more preferably 165 to 800 cc.

[0160] In another embodiment, the wrapping is configured to form an unstretched volume slightly smaller than the volume of the breast implant (e.g., 5% to 10%). When the breast implant is wrapped by the device, the device stretches to accommodate the entire contour of the breast implant. The fit is comfortable and substantially wrinkle-free.

[0161] The cover preferably has a shape that allows it to at least partially cover the breast implant without any unwanted protuberance that would interfere with implantation in the breast or impair the final appearance of the breast.

[0162] In one embodiment, the breast implant fixation package device further includes one or more connectors for securing the breast implant inside the package.

[0163] In some embodiments, the breast implant fixation package further includes one or more tabs. These tabs can be used to anchor the package in place within the patient. For example, the tabs can be anchored by suturing or staples. The tabs are positioned such that they are located on the package opposite to the breast implant, and more preferably, on the opposite side of the package of the breast implant, and at one or more locations around the outer edge of the breast implant. In a preferred embodiment, the package includes tabs positioned high in the breast when the package containing the breast implant is implanted into the breast. A package with tabs that can be fixed high to the patient (e.g., to the pectoralis major muscle) can be used to maintain the vertical positioning of the breast implant, minimize implant movement, and prevent underside instability. Any number of tabs can be incorporated into the package, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12, but more preferably, four straps can be incorporated at 90-degree intervals from each other, such that they are located around the outer edge of the breast implant. Most preferably, the flap is positioned on the package such that when the package containing the breast implant is placed in the patient's breast, the flap is located above, below, in the middle, and on the outside of the breast implant.

[0164] In some embodiments, the breast implant fixation package is preferably shaped and sized to cover at least a portion of the breast implant, but more preferably the entire breast implant. The size and shape of the package used in the procedure may be based on the surgeon's and patient's choice of breast implant size and shape, and the need to closely match these requirements with the size and shape of the package so that the breast implant is at least partially covered and secured within the package.

[0165] Preferably, the package is porous, or becomes porous after implantation, and even more preferably, the package is macroporous or becomes macroporous after implantation. In a preferred embodiment, the package comprises pores with an average pore diameter of at least 100 μm, more preferably at least 250 μm, and even more preferably at least 500 μm. Particularly preferred pore diameter is 800 μm ± 300 μm. Particularly preferred pore size is 0.64 mm. 2 ± 0.3 mm 2 The packages can be made of porous materials, or they can be made of non-porous materials. In some embodiments, packages made of non-porous materials are then perforated.

[0166] In some embodiments, the material used to form the package has one or more of the following properties: (i) a burst strength of 0.1 to 30 kgf / cm 2 (ii) suture pull strength of 1 to 7 kgf, and (iii) areal density of 40 to 190 g / m³.2 In a particularly preferred embodiment, the wrapping material comprises poly-4-hydroxybutyrate or a copolymer thereof, or poly(butylene succinate) or a copolymer thereof, even more preferably in the form of textiles or other porous structures.

[0167] Breast implant fixation devices may contain the additives listed in Section II.B and the bioactive agents listed in Section II.C. Breast implant fixation devices may be coated with one or more of the following: bioactive agents, antibiotics, antimicrobial agents, autologous fat, liposuction, injectable fat, adipocytes, fibroblasts, stem cells, collagen, and hyaluronic acid.

[0168] The prepared encapsulation preferably has an endotoxin content of less than 20 endotoxin units, making it suitable for implantation in patients.

[0169] Some examples of breast implants that can be included in a package include silicone and saline breast implants, anatomical and round breast implants, and breast implants with and without surface texture. Some non-limiting embodiments of breast implants include: (i) Mentor's MemoryShape® breast implants, MemoryGel® breast implants, and Spectrum® breast implants; (ii) Allergan's Natrelle® breast implants, including gel-like breast implants, Inspira® responsive, soft-touch, and adhesive breast implants, Natrelle® 410 anatomical implants, Natrelle® saline-filled breast implants, and Biocell™ breast implants; (iii) Sientra's Opus™ breast implants, including smooth round, textured round, and textured shapes, high-strength adhesive breast implants, HSC, and HSC+; (iv) Arion Laboratories' Monobloc® silicone and hydrogel-CMC breast implants; (v) Cereform® breast implants from Cerelas; (vi) Establishment Labs' Motiva® breast implants, including its Ergonomix™ and Round breast implants; (vii) GC Aesthetics’ Eurosilicone® and Nagor® breast implants, including Impleo™, CoGEL™, Eurosilicone® Round Collection, Eurosilicone® Matrix, Nagor® GFX™ and Nagor® RGI™ breast implants; (viii) Groupe Sebbin’s inflatable, viscous round, high-viscous round, low-anatomical and high-anatomical breast implants; (ix) Guangzhou Wanhe Plastic Materials’ Snow.Lambe, Crystal.Lambe and Lambe breast implants; (x) Hans Biomed’s BellaGel breast implants; (xi) IdealImplant Incorporated’s Ideal Implant® breast implants; (xii) Polytech Health and Aesthetics’ Mesmo®, Polytxt®, Microthane®, SublimeLine® and Diagon\Gel®4 Two breast implants; and (xiii) Silimed breast implants, including conical, round and anatomical shapes.Further examples of breast implants for use with embodiments of the present invention are disclosed in: Maxwell and Gabriel, The evolution of breast implants, Plast. Reconstr. Surg. 134:12S, 2014 and references therein; U.S. Patent No. 10,052,192 to Schuessler; U.S. Patent No. 6,074,421 to Murphy; U.S. Patent No. 5,007,929 to Quaid; U.S. Patent No. 8,211,173 to Keller; U.S. Patent No. 4,960,425 to Yan; U.S. Patent No. 4,380,569 to Shaw; U.S. Patent No. 5,902,335 to Snyder; U.S. Patent No. 3,293,663 to Cronin; U.S. Patent No. 4,863,470 to Carter; U.S. Patent No. 4,773,909 to Chaglassian; and U.S. Patent No. 10,052,192 to Murphy. 6,074,421, Schuessler's U.S. Patent No. 8,377,127 and Schuessler's U.S. Patent No. 8,043,373.

[0170] A. Examples of packaging design

[0171] In a preferred embodiment, the breast implant fixation wrapping device is designed to restrict movement of the breast implant using a tab in the cover portion and a receiving slit for the tab in the base portion. Figure 2 A schematic diagram is shown of a wrapping (200) having a tab in the covering portion and a receiving slit for the tab in the base portion. The wrapping may include a base portion (210) adapted to wrap the posterior portion of a breast implant (see [reference]). Figure 1A , 1B (These are the posterior and anterior locations on the breast implant, respectively). The base portion (210) shown has a circular or oval region. In some embodiments, the shape of the base portion may be approximately sized to match the shape of the posterior portion of the breast implant. In some embodiments, the base portion may have a non-circular shape.

[0172] Figure 2 A covering portion (220) suitable for enclosing the anterior portion of a breast implant is also shown. This differs from the base portion (210). Figure 2The illustrated cover portion (220) shows a plurality of extension members 260, each of which terminates at a tab (230), which will be further described herein. The extension members 260 extend radially from the center of the cover portion (220). Adjacent extension members are defined or characterized by gaps, preferably as follows: Figure 2 The V-shaped incision is shown. However, the incision or gap can take other shapes, such as U-shaped, bowl-shaped, or trapezoidal. As further described herein, the presence of the extension and incision facilitates a close and comfortable fit above the top of the breast implant and helps to eliminate creases and wrinkles.

[0173] A hinge portion (250) connects the base portion (210) and the cover portion (220). The cover (200) can be folded along the hinge portion (250) to allow the base portion (210) and the cover portion (220) to at least partially cover the breast implant. After the rear portion of the breast implant is placed on the base portion (210) of the cover (200), the cover portion (220) can be wrapped over the front portion of the breast implant and secured in place by inserting tabs (230) on the cover portion (220) into slits (240) in the base portion (210). When the rear portion of the breast implant is placed on the base portion (210) of the cover (200) and the cover portion (220) is wrapped over the front portion of the breast implant, the shape and independently radial extensions of the cover are adapted to follow the contour of the breast implant. Without being bound by theory, a cover portion with a different geometry and features than the base portion to which it is connected is provided to reduce wrinkles and creases in the top of the breast implant after surgery.

[0174] Figures 6 to 7 Bottom and top perspective views of a breast implant package (600) arranged in a 3D configuration according to an embodiment of the present invention are shown. A tab (610) covering the portion is shown protruding from a slit (620). Figures 6 to 7 In the illustrated embodiment, the tab (610) is used to anchor the package in the patient's position and to connect the cover portion and the bottom portion to each other.

[0175] In an alternative embodiment, the tab (230) may be attached to the base portion (210), or to both the base portion and the cover portion. Optionally, the tab (230) may be secured to the base portion (210) after being inserted into the slit (240). For example, by suturing, heat bonding, or using an adhesive.

[0176] Optionally, although not shown, a pleat or fold may be incorporated into a portion of the wrapping to replace an incision and is designed to minimize wrinkling of the wrapping when it is used to cover a breast implant.

[0177] The tabs (230) can also be used to secure the package to the patient's breast. Additionally, the package (200) may include one or more additional tabs to allow the package to be secured within the breast. Preferably, the package (200) includes tabs for securing to the patient, which are positioned high within the breast when the package containing the breast implant is placed within the breast.

[0178] In another preferred embodiment, the package is designed to restrict movement of the breast implant by using a base portion that is interconnected to secure the breast implant within the package. Figure 3 A schematic diagram of a package (300) having interlocking base portions to enclose a breast implant is shown. The package (300) includes a cover portion (320) for enclosing over the front portion of the breast implant and eight base portions (310) connected to the cover portion (320) via hinge portions (350). After the front portion of the breast implant is placed on the cover portion (320) of the package, the eight base portions (310) connected to the hinge regions (350) can be folded over the rear portion of the breast implant and interconnected to secure the breast implant inside the package (300). When the eight base portions (310) are interconnected to enclose the breast implant, the package (300) is designed to minimize wrinkling of the package. Optionally, the base portions (310) may be secured, for example, by suturing, thermal bonding, spot welding, or using adhesives.

[0179] The package (300) may also include one or more tabs (not shown) to allow the package to be secured in the breast. Preferably, the package (300) includes tabs for securing to the patient, which may be positioned high in the breast when the package containing the breast implant is placed in the breast.

[0180] In another embodiment, the breast implant fixation package is designed such that only the posterior portion of the breast implant is partially covered. This design allows the surgeon to pre-assemble the package before inserting the breast implant. Figure 4 The diagram shows a package (400) in which the base of the breast implant is not fully covered during device use. The package contains... Figure 2 The base portion (410) of the approximate semicircle opposite to the full circle (210) shown. Figure 4As shown, the semi-circular base portion (410) is connected to the covering portion (420) via a hinge area (450). The covering portion (420) includes tabs (430) that can engage in slits (440) of the base portion (410). The package (400) can be assembled prior to surgery, allowing the introduction of the breast implant after device assembly. Preferably, the package (400) containing the breast implant has minimal wrinkling. The gaps (460) in the package (400) are designed to minimize wrinkling of the package when it is used to cover the breast implant. Optionally, the tabs (430) can be secured to the base portion (410) after insertion into the slits (440). For example, by suturing, thermal bonding, or using adhesives. The tabs (430) can also be used to secure the package to the patient. The package (400) may also include one or more additional tabs to allow the package to be secured in the breast. Preferably, the package (400) includes a tab for fixation to the patient, which can be positioned high when the package containing the breast implant is placed in the breast.

[0181] In another embodiment, the breast implant fixation wrapping device includes a stretchable textile, particularly in the coverage portion. Preferably, the stretchable textile stretches less than 50% under a bidirectional burst load. An illustration of a wrapping design in which the coverage portion includes a stretchable textile is shown in [illustration missing]. Figure 5 In the middle. And Figure 4 The covering portion (420) shown has a wrapping (400) designed to minimize the formation of wrinkles. Conversely, in Figure 5The covering portion (520) of the package (500) does not contain gaps. Instead, the covering portion (520) of the package (500) contains a stretchable textile that does not wrinkle when the covering portion is wrapped around the breast implant. The package (500), like the package (400), can be assembled prior to surgery by placing the tabs (530) of the base portion (510) in the slits (540) of the covering portion and then inserting the breast implant into the package. Alternatively, the rear portion of the breast implant can be placed on the base portion (510) of the package (500) and wrapped in the package by placing the covering portion (520) above the front portion of the breast implant and inserting the tabs (530) through the slits (540) to secure the breast implant in the package. In either case, after insertion into the slit (540), the tab (530) can be secured to the covering portion (520) by, for example, suturing, thermal bonding, spot welding, or using adhesive. The tab (530) can also be used to secure the package to the patient. The package (500) may also include one or more additional tabs to allow the package to be secured in the breast. Preferably, the package (500) includes tabs for securing to the patient, which can be positioned high when the package containing the breast implant is placed in the breast. In some embodiments, the package is formed such that the covering portion (520) has greater elasticity than the base portion (510).

[0182] In another preferred embodiment, the package may comprise a base portion and a separate cover portion not attached to the base portion. The separate base portion and cover portion may be secured together to encapsulate the breast implant. The cover portion preferably has a three-dimensional shape, and more preferably has a shape and size that covers the front of the breast implant. The cover portion is preferably shaped to conform to the contour of the front of the breast implant without wrinkling. The base portion is preferably two-dimensional, but may have a three-dimensional shape, wherein the outer edge of the base portion has a concave shape. The concave shape may be designed to surround the outer edge of the breast implant and cover the top (130) and bottom (140) portions of the breast implant. The base portion, the cover portion, or both portions may also include one or more tabs to secure the breast implant within the package. The package may also be assembled around the breast implant by suturing, gluing, or thermal bonding. Tabs may also be used to secure the package to the patient. The package may include one or more additional tabs for securing the device to the patient's chest wall.

[0183] The packages disclosed herein (e.g., not limited to 200, 300, 400, 500) are designed such that the covered portion of the package preferably covers most, and even more preferably all, of the breast implant protruding from the patient's chest. In one embodiment, the package is designed to accommodate a breast implant protruding from the chest wall in a length of 4 to 8.5 cm, and more preferably 4.2 to 7 cm.

[0184] The packages disclosed herein (e.g., not limited to 200, 300, 400, 500) preferably have a base portion with a width of 7.4 to 17.2 cm, and more preferably 9 to 16.5 cm.

[0185] The package disclosed herein may have a base portion or a covering portion comprising one or more circular sections or sectors.

[0186] The present invention includes a wide range of mechanisms for attaching a cover portion of a package to a base portion of the package. Exemplary mechanisms for attaching the cover portion to the base portion and securing a breast implant therein include, but are not limited to, sutures, flaps, slits, snap fasteners, ties, buckles, straps and cords, as well as thermal bonding, spot welding, or the use of adhesives.

[0187] B. Wrappers with different thicknesses, pore sizes, and elasticities.

[0188] In other embodiments, the breast implant fixation wrapping device may be prepared from one or more materials with different pore sizes, one or more materials with different elasticities, or one or more materials with different thicknesses, or combinations thereof. In one embodiment, materials with different pore sizes, different thicknesses, or suitable shapes with both different pore sizes and different thicknesses may be joined together, for example, by sewing, gluing, or welding, to form a wrapping for the implant. In another embodiment, the wrapping may be cut from sheets with different pore sizes, different thicknesses, or combinations thereof. The material used to construct the wrapping is preferably porous, and more preferably a textile, including woven, nonwoven, monofilament, multifilament, and knitted textiles. In a particularly preferred embodiment, the textile is a monofilament mesh, and even more preferably a monofilament mesh with a Marlex knit pattern.

[0189] Preferably, the thickness of the covering portion of the package (e.g., 220, 320, 420) (which is placed under the patient's skin) is 0.5 to 10 mm, and the thickness of the base portion of the package (e.g., 210, 310, 410) (which is placed next to the chest wall) is 0.2 to 0.6 mm. Packages with a thicker covering portion prevent the formation of ripples and indentations on the patient's skin caused by ripples present on the breast implant, and reduce or eliminate the tactile detectability of the breast implant. The use of a package with a thicker covering portion is particularly important in patients with thin skin or in patients in whom excessive tissue has been removed (e.g., during radical mastectomy procedures).

[0190] In another embodiment, the wrapping for securing the breast implant can be prepared with different apertures in different regions of the wrapping. Preferably, the wrapping has larger apertures in the basal portion of the wrapping (e.g., 210, 310, 410) (which contacts the chest wall after implantation), and smaller apertures in the top portion covering the breast implant (see [link to original document]). Figure 1B The package is prepared with smaller holes in the coverage area (e.g., 220, 320, 420) of the "top side" location. This latter area is located at the upper pole of the breast under the patient's skin after implantation. Larger holes in the base portion of the package improve its drape. Smaller holes in the coverage portion of the package covering the top side of the breast implant increase the surface area available for encapsulating fat and allow for the delivery of more fat to the upper pole of the breast. In a preferred embodiment, the average pore diameter in the different areas of the package is: 0.5 to 3 mm in the base portion of the package, and in the area covering the top side of the breast implant (see...) Figure 1B The coverage area of ​​the package in the top side position is 0.1 to 1 mm, and in the area covering the bottom side of the breast implant (see [reference]). Figure 1A The thickness of the covering portion of the package (at the bottom side position) is 0.5 to 1 mm.

[0191] In one embodiment, the wrapping material has such elasticity that it can easily and snugly wrap around the breast implant. Preferably, the wrapping material is formed of a covering portion (e.g., 220, 320, 420, 520) with an elasticity of 15% to 75% or 30% to 65% (which sits directly under the patient's skin) and a base portion (e.g., 210, 310, 410, 510) with an elasticity of 5% to 25% or 8% to 20% (which sits on the patient's chest wall), wherein the elasticity is measured as the percentage increase in area when deformation occurs in the area using the ASTM rupture method D6797-02 using a sphere. In a particularly preferred embodiment, a wrapping material may be selected such that the covering portion of the wrapping material has an elasticity of 30% to 65% and the base portion of the wrapping material has an elasticity of 8% to 20%.

[0192] C. Preparation of the package

[0193] In some embodiments, wrappers with tabs and slits (e.g., 200, 400, 500) or wrappers with interlocking portions (e.g., 300) can be formed using fiber-based structures, including structures formed by meltblowing, solution spinning, dry spinning, electrospinning, centrifugal spinning, melt spinning, knitting, weaving, braiding, fiber entanglement, 3D printing, and embedded fibers in other structures, such as embedded fibers in foams, membranes, laminates, and fibers covering membranes and foams. Fiber-based structures can include monofilaments, multifilaments, 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 copolymers thereof or poly(butylene succinate) or copolymers thereof, and (ii) dry-spun nonwoven fabrics, and even more preferably dry-spun nonwoven fabrics comprising P4HB or poly(butylene succinate) or copolymers thereof. In a particularly preferred embodiment, the wrapping for the breast implant is formed of a knitted monofilament mesh comprising P4HB or copolymers thereof or poly(butylene succinate) or copolymers thereof, or of a mesh prepared as described in Section II.G above. The monofilaments preferably have an average fiber diameter of 0.04 mm to 0.35 mm, but more preferably 0.05 mm to 0.2 mm. Figure 2 and Figure 3 The package shown can be prepared from a knitted monofilament fiber mesh and cut to form... Figure 2 and Figure 3 The shape shown. Knitted mesh can be cut using, for example, a sharp blade, scissors, or a laser.

[0194] In other embodiments, the covering portion of the package (e.g., 220, 320, 420, 520) may be formed from a non-fibrous structure (e.g., a membrane, laminate, or foam), or a structure comprising a combination of fibers, membranes, or foams. The covering portion of the package may also be formed from a non-porous structure and subsequently perforated.

[0195] For example, the following method steps can be used to prepare a breast implant fixation device: (i) preparing a monofilament knitted mesh, (ii) using, for example, in Figures 2 to 5The method involves (iii) preparing a template in the shape shown, placing the template on a knitted mesh, and (iv) cutting around the template to form a package. The mesh is ideally cut with a laser, but can also be cut with scissors, a template, 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 containing P4HB or a copolymer thereof, or containing poly(butylene succinate) or a copolymer thereof. In another embodiment, tabs may be added to the package to secure it to the patient. Alternatively, the template may be modified such that mesh tabs are formed when the package is cut from the mesh. Preferably, the mesh tabs are located around the outer edge of the base portion of the package.

[0196] Breast implant fixation wraps can also be made from nonwoven structures. For example, the wrap can be prepared using the following methods: (i) preparing a nonwoven structure, (ii) using, for example... Figures 2 to 5 The process involves (iii) preparing a template in the shape shown, placing the template on the nonwoven structure, and (iv) cutting around the template to form an envelope. A particularly preferred polymer for preparing the nonwoven envelope is P4HB or a copolymer thereof. Another particularly preferred polymer for preparing the nonwoven envelope 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 fabric without any 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 the dry spinning of the nonwoven fabric.

[0197] In another embodiment, the package for securing a breast implant is formed by 3D printing. Suitable methods for 3D printing the package include filament preparation, fused pellet deposition, melt extrusion deposition, selective laser melting, printing slurries and solutions using a coagulation bath, and printing using binder solutions and powder particles. Preferably, P4HB or poly(butylene succinate) or copolymers thereof are used to 3D print the package.

[0198] In another embodiment, the package for securing a breast implant is formed by: a base portion (e.g., 220, 320, 420, 520) of the package made of a first mesh and a covering portion (e.g., 210, 310, 410, 510) of the package made of a second mesh, and the two meshes are ultrasonically or thermally sealed together at a hinge. In some embodiments, the second mesh is stretchable beyond the first mesh. In some embodiments, the second mesh has greater elasticity than the first mesh. In some embodiments, the first and second meshes are woven from fibers, and the average diameter of the fibers used to weave the first mesh is greater than the average diameter of the fibers used to weave the second mesh. In some embodiments, the average diameter of the fibers used to weave the first mesh is 0.1 to 0.149 mm. In some embodiments, the average diameter of the fibers used to weave 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 portion (e.g., 210, 310, 410, 510) is formed of a Marlex mesh knitted pattern made of fibers with an average diameter of 0.1 to 0.149 mm, while the cover portion (e.g., 220, 320, 420, 520) is formed of a diamond knitted pattern made of fibers with an average diameter of 0.07 to 0.099 mm.

[0199] IV. Methods of implanting a package containing a breast implant to restrict movement

[0200] A package containing a breast implant can be implanted in the body. Preferably, the package containing the breast implant is implanted in the breast. More preferably, the package is implanted in a breast in which the patient is seeking breast reconstruction or enlargement.

[0201] Breast implants are preferably encased in or inserted into a package before implantation; however, in some embodiments, the package may be implanted in the patient and the breast implant may then be placed within the package.

[0202] In a preferred embodiment, the method includes providing a wrapping with an initial flat or planar configuration. The flat or planar configuration includes a base portion and a cover portion connected 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.

[0203] Next, the cover portion is pulled tightly over the breast implant and secured to the base portion, thus removing any wrinkles on the cover portion.

[0204] Optionally, one or more tabs on the cover portion may be pulled more tightly to the base portion to remove any creases or wrinkles present in the cover portion. In a preferred embodiment, and again refer to Figure 2 The tab (230) can be inserted through the slit (240) and pulled to secure the breast implant and remove any creases or wrinkles present in the coverage portion. The tab and slit are used to provide the physician with an implant-based mechanism to adjust the fit of the coverage portion to the implant and to adjust (i.e., reduce) the number of creases or wrinkles on the coverage portion. The implant is designed to provide a smooth surface to cover the front of the breast implant, minimizing or eliminating skin dimpling or ripples on the patient's breast surface. The tab (230) is inserted into the slit (240) and secured so that the coverage portion (220) can cover the front of the breast implant without forming visible wrinkles on the breast surface. Optionally, the tab can be secured to the breast implant within the package, for example by suturing, molding, welding, or using adhesives.

[0205] In another preferred embodiment, the method includes providing a package having a covering portion and a separate base portion. The breast implant is placed on the base portion, and the covering portion is placed on the front of the breast implant, and vice versa.

[0206] Next, secure the cover portion and the base portion together to remove wrinkles on the cover portion.

[0207] Optionally, the covering portion and the base portion are secured together with one or more tabs present on one or more portions.

[0208] In a preferred embodiment, the package containing the breast implant is used for breast reconstruction, particularly after mastectomy and breast augmentation (including augmentation mastectomy). The package containing the breast implant can be placed in a pouch formed solely by the patient's tissue within the breast, or in a pouch formed using an implant (e.g., a pectoralis extender, such as acellular dermal matrix (ADM), P4HB mesh, a mesh of poly(butylene succinate) or copolymers thereof, or other materials that can form a hammock or sling within the breast). If desired, a tissue expander can be used to form or enlarge the pouch.

[0209] In one embodiment, the procedure for implanting a package containing a breast implant after mastectomy includes forming a pouch in the patient's breast suitable for receiving the package containing the breast implant, and implanting the package containing the breast implant. In a preferred procedure for implanting a package containing a breast implant into a patient after mastectomy, the implantation method includes: (i) implanting a tissue expander in the patient; (ii) implanting a pectoral muscle expander near the tissue expander; (iii) expanding the tissue expander; (iv) removing the tissue expander; and (v) implanting the package containing the breast implant into the pouch created in the patient's breast. Preferably, the pectoral muscle expander is sutured to the separated pectoralis major muscle and moved to prepare for placement of the tissue expander. The sutures may be permanent or absorbable, but absorbable is preferred. Once sutured to the pectoralis major muscle, the pectoral muscle expander may be used as a sling or strap to cover the lower portion of the inserted tissue expander. The tissue expander may be partially inflated or uninflated before implantation. In the latter case, the tissue expander may be partially inflated immediately after implantation.

[0210] In one embodiment, the procedure for implanting a package containing a breast implant in a patient desiring breast augmentation includes implanting the packaged breast implant in an anterior chest location (subglandular location) to eliminate the need for muscle separation from the chest wall and to reduce pain associated with muscle separation from the chest wall. However, in other embodiments, the package containing the breast implant may be implanted in a subchest or submuscular location, if desired.

[0211] Preferably, the package containing the breast implant can be secured in place. In one embodiment, the package includes one or more flaps or similar extensions that can be fastened to the patient's tissue. The flaps can be secured to the patient's tissue using sutures, tacks, clips, staples, or similar fastening devices. In a particularly preferred implantation method, the package includes a superior flap located mid-high in the patient. The superior flap can be used to secure the package to the pectoralis major muscle to maintain the vertical positioning of the breast implant, prevent inferior instability, and minimize implant movement. Alternatively, the package can be secured in place by, for example, using sutures, tacks, staples, or other fastening devices and materials to directly attach the package to the patient's chest wall.

Claims

1. A breast implant fixation device for securing a breast implant in a patient, comprising: The base portion, the cover portion, and the hinge region connecting the base portion to the cover portion; The implant fixation device described herein comprises a substantially planar two-dimensional first configuration; and A folded three-dimensional second configuration, comprising at least partially covering the shape and size of the breast implant when the covering portion wraps around the front portion of the breast implant and is secured to the base portion; and The elasticity of the covering portion is greater than that of the base portion.

2. The device of claim 1, wherein the elasticity of the covering portion is 15% to 75%.

3. The device of claim 1, wherein the elasticity of the base portion is 5% to 25%.

4. The device of claim 1, wherein the base portion and the cover portion comprise a plurality of holes.

5. The apparatus of claim 4, wherein the average diameter of the holes in the covering portion is smaller than the average diameter of the holes in the base portion.

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

7. The apparatus of claim 1, wherein the thickness of the covering portion is greater than the thickness of the base portion.

8. The apparatus of claim 1, wherein the base portion is formed of a first mesh and the covering portion is formed of a second mesh, and wherein the elasticity of the second mesh is greater than that of the first mesh.

9. The apparatus of claim 8, wherein the first mesh and the second mesh are formed of 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. The device of claim 1, further comprising a plurality of tabs and a plurality of slits, wherein each slit is adapted to receive a tab such that the covering portion can be tightened to eliminate wrinkles in the covering portion.

11. A breast implant fixation device that restricts movement of a breast implant in a patient, comprising: A two-dimensional first configuration includes a base portion, a cover portion, and a hinge region connecting the base portion to the cover portion; and The second three-dimensional configuration includes at least partially covering the shape and size of the breast implant when the covering portion wraps around the front portion of the breast implant and is secured to the base portion; and The base portion and the cover portion contain at least one of a plurality of holes.

12. The device of claim 11, wherein the base portion is adapted to be positioned to contact the rear portion of the breast implant, and the covering portion is adapted to fold over the front portion of the breast implant.

13. The device of claim 11, further comprising one or more tabs for anchoring the device to the patient's chest wall to prevent movement of the breast implant.

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

15. The device of claim 11, wherein the base portion or covering portion further comprises one or more tabs for securing the breast implant within the fixation device.

16. The device of claim 11, wherein the base portion or covering portion further comprises one or more slits or openings for securing the breast implant within the fixation device.

17. The device of claim 11, wherein the base portion or covering portion comprises one or more circular portions or regions.

18. The device of claim 11, wherein when the breast implant is enclosed in the device and the device is implanted in the patient's breast with its base portion placed on the patient's chest wall and its covering portion placed under the patient's skin, the thickness of the covering portion of the device is sufficient to prevent the breast implant from being palpable, or sufficient to conceal any ripples or dents in the patient's skin.

19. The device of claim 11, wherein the covering portion has an elastic range selected from 15% to 75% and 30% to 65%, or the base portion has an elastic range selected from 5% to 25% or 8% to 20%.

20. The device of claim 11, wherein when the breast implant is enclosed in the device and the device is implanted in a patient's breast, the elasticity of the covering portion increases from the area in contact with the top of the breast implant to the area in contact with the bottom of the breast implant.

21. The device of claim 11, wherein the device has one or more of the following thicknesses: the thickness of the covering portion of the package is 0.5 to 10 mm, or the thickness of the base portion of the package is 0.2 to 0.6 mm.

22. The device of claim 11, wherein the thickness of the covering portion is greater in the region that contacts the top of the breast implant than in the region that contacts the bottom of the breast implant, or optionally, wherein the covering portion has a preset memory or shape memory that matches the curvature of the top of the breast implant.

23. The device of claim 11, wherein the device has one or more of the following apertures: an average aperture diameter of 0.1 to 1 mm in the covering portion of the device, and an average aperture diameter of 0.5 to 3 mm in the base portion of the device.

24. The apparatus of claim 11, wherein the apparatus comprises one or more of the following: textiles, woven textiles, nonwoven textiles, monofilament webs, or multifilament webs.

25. The device of claim 24, wherein the device has at least one of the following characteristics: (i) a breaking strength of 0.1 to 30 kgf measured using ASTM breaking method D6797-02 with a sphere of 3 / 8 inch diameter; (ii) a suture pull-out strength of 1 to 7 kgf; and (iii) a areal density of 40 to 190 g / m³. 2 .

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

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

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

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

30. A method for preparing a breast implant fixation device that restricts movement of a breast implant in a patient, comprising: A two-dimensional package is formed having a shape and size that at least partially covers the breast implant, wherein the package includes a base portion, a cover portion, and a hinge connecting the base portion to the cover portion.

31. The method of claim 30, wherein the method further comprises forming one or more tabs in the package for securing the breast implant within the fixation device.

32. The method of claim 30, wherein the method further comprises forming a cover portion with a thickness greater than that of the base portion, forming a cover portion with an average hole diameter smaller than that of the base portion, forming a cover portion with an elasticity of 15% to 75% and a base portion with an elasticity of 5% to 25%, or forming a cover portion having an elasticity different from that of the base portion.

33. A method of implanting the device of claim 11, comprising: Select the package; The breast implant is placed inside the package; And positioning the package containing the breast implant in the patient's breast.

34. A method of implanting the device of claim 11, comprising: Provide the package; Place the breast implant on the base portion and fold the covering portion over the breast implant; And positioning the package containing the breast implant in the patient's breast.

35. The method of claim 34, further comprising tightening the covering portion over the front of the breast implant to remove wrinkles.

36. A breast implant encapsulation comprising: A thin-film two-dimensional first configuration, the first configuration further comprising a base portion, a cover portion, and a hinge region connecting the base portion to the cover portion; and The second three-dimensional configuration includes at least partially covering the shape and size of the breast implant when the covering portion is folded around the front of the breast implant and secured to the base portion.

37. The breast implant cover of claim 36, wherein the covering portion has a profile selected from the following: star-shaped, flower-shaped, and gear-shaped.

38. The breast implant wrapping of claim 37, wherein the covering portion has a central region and a plurality of extending members (or finger-like members, petal-like members, or tooth-like members) extending radially from the central region.

39. The breast implant package of claim 38, wherein the number of the extension members is 4 to 8.

40. The breast implant package of claim 36, wherein the base portion has a profile selected from the following: circular, semi-circular, teardrop-shaped, and elliptical.

41. A breast implant wrap for restricting movement of a breast implant in a patient, comprising: A sheet-like two-dimensional first configuration, the first configuration further comprising a covering portion and a plurality of base portions extending radially from the covering portion; and The second three-dimensional configuration includes at least partially covering the shape and size of the breast implant when each of the base portions is folded around the breast implant and secured to each other.

42. The breast implant package of claim 41, wherein the first configuration has a profile selected from the following: star-shaped, flower-shaped, and gear-shaped.

43. Any covering used to secure the breast implant described herein.

44. Any method for encapsulating the breast implant described herein, and optionally, any method for implanting the encapsulated breast implant into a patient.

45. A breast implant fixation device that restricts movement of a breast implant in a patient, comprising: A base portion and a separate three-dimensional covering portion; wherein the covering portion includes at least partially covering the shape and size of the breast implant when the covering portion wraps around the front of the breast implant and is secured to the base portion to surround the breast implant; and wherein at least one of the base portion and the covering portion includes a plurality of holes.

46. ​​The device of claim 45, wherein the base portion has a two-dimensional shape or a three-dimensional shape having a concave shape around its outer edge.

47. The device of claim 45, wherein the base portion, the covering portion, or both portions have one or more tabs for securing the breast implant within the device.

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

49. The device of claim 45, wherein when the breast implant is secured in the device and the device is implanted in the patient's breast with its base portion placed on the patient's chest wall and its covering portion placed under the patient's skin, the thickness of the covering portion is sufficient to prevent the breast implant from being palpable, or sufficient to conceal any ripples or dents in the patient's skin.

50. The device of claim 45, wherein the elasticity of the covering portion is greater than that of the base portion.

51. The device of claim 50, wherein the elasticity of the covering portion is 15% to 75%.

52. A method for preparing a breast implant fixation device that restricts movement of a breast implant in a patient, comprising: Forming a base portion and a separate three-dimensional covering portion; The covering portion includes at least partially covering the shape and size of the breast implant when the covering portion wraps around the breast implant, and the covering portion can be secured to the base portion to surround the breast implant.

53. The method of claim 52, further comprising forming one or more tabs in the base portion or the covering portion for securing the breast implant within the fixation device.

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

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

56. The method of claim 54, further comprising adjusting the tightness of the covering portion by manipulating one or more of the tabs.

57. A breast implant fixation device for securing a breast implant in a patient, comprising: A first portion, a second portion, and a hinge region connecting the first portion to the second portion, wherein the implant fixation device comprises a substantially planar two-dimensional first configuration; and A folded three-dimensional second configuration comprising at least partially covering the shape and size of the breast implant when the second portion is wrapped around the front portion of the breast implant and secured to the first portion; and wherein the elasticity of the second portion is greater than that of the first portion.

58. A method for performing breast implant surgery, comprising: Provide a package comprising a first configuration that is pouchless and substantially planar; The breast implant is placed on the base portion of the package and the covering portion is folded over the front portion of the breast implant, such that the package forms a 3D second configuration surrounding the breast implant; Adjust the tightness of the covering portion above the top of the breast implant to remove wrinkles and creases on the breast implant; While stretching the covering portion, the covering portion is fixed to the base portion; as well as The package containing the breast implant is positioned in the patient's breast.

59. The method of claim 58, wherein the fixing step is performed by interlocking a plurality of radially extending toothed members with a plurality of slits, each slit being adapted to receive a single toothed member.

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