Method and implantable prosthesis for anatomical reconstruction and / or augmentation - Patents.com

Abstract

A prosthesis for reconstructing and / or augmenting an anatomical shape. The prosthesis may have a three-dimensional form for reconstructing and / or augmenting the anatomical shape of a human breast. The prosthesis may be configured to encourage ingrowth of fat and / or tissue to fill the vacant space within and around the prosthesis. The prosthesis may use a structure having multiple cavities to allow fat and / or tissue to fill and pass through the structure and to bulge the anatomical shape of the reconstructed and / or augmented breast. The prosthesis may include a hollow core that may be accessible from one or both ends of the prosthesis. The prosthesis may be fabricated using multiple segments and / or layers of material that may be placed around the core and joined to create the desired shape of the prosthesis.

Description

[Technical field]

[0001] Related Applications The benefit of foreign priority under 35 USC § 119(a)-(d) or 35 USC § 365(b) is claimed from U.S. patent application Ser. No. 63 / 217,054, filed June 30, 2021, Ser. No. 63 / 217,075, filed June 30, 2021, Ser. No. 63 / 217,089, filed June 30, 2021, Ser. No. 63 / 217,105, filed June 30, 2021, and Ser. No. 63 / 217,170, filed June 30, 2021, each of which is incorporated herein by reference.

[0002] Field The present disclosure relates to implantable prostheses, and more particularly to prostheses for the reconstruction and / or augmentation of anatomical shapes, including the human breast. [Background technology]

[0003] background Breast reconstruction is primarily performed following the diagnosis and surgical treatment of breast cancer, however, more and more patients are choosing breast reconstruction as a preventative option in response to the results of genetic testing that can indicate individuals at high risk for breast cancer.

[0004] Breast reconstruction can generally be classified as autograft and non-autograft. In autograft reconstruction, the patient's own tissue is harvested from another part of the patient's body and then used to reconstruct the breast. In non-autograft reconstruction, artificial implants, such as saline, silicone or gel implants, are used to reconstruct the breast fullness.

[0005] Autograft reconstruction generally involves harvesting a tissue flap from the patient's abdomen. This procedure can maintain the vascular supply to the patient's tissue and generally results in a cosmetically pleasing outcome for the patient. However, such procedures can be time consuming, may involve microsurgery to reconnect the vascular supply, and require relatively long recovery times. They can also result in functional impairment and weakness at the site where the tissue was removed. This technique may not be available to some patients who do not have abdominal volume or can afford to lose muscle mass.

[0006] Non-autologous implant reconstruction, which includes the majority of breast reconstruction procedures, may use a single-stage or intermediate reconstruction procedure or a two-stage reconstruction procedure. The mastectomy and breast reconstruction may be performed simultaneously (single-stage) or may be staged into multiple procedures (two-stage). In each procedure, breast implants are generally placed below the pectoral muscle, i.e., sub-pectoral, to conceal the implant from view through the skin and to allow muscle to cover the relatively rigid implant.

[0007] In a single-stage procedure, the breast tissue is completely dissected and removed after a small incision is made under the breast. The pectoral muscle is then retracted at its inferior end and the submuscular plane is expanded to create a subpectoral pocket of sufficient size to accommodate the implant. Acellular dermal matrix (ADM) is typically used to reattach the muscle and further reinforce the underside of the implant.

[0008] Single-stage procedures generally offer less control over the cosmetic outcome because they cannot be adjusted over time. These procedures can also result in tissue necrosis if the implant is too large for the size of the submuscular pocket.

[0009] In a two-stage procedure, the initial surgical phase is similar to the single-stage procedure. However, rather than placing an implant in the submuscular pocket, an ADM is placed in the pocket first, followed by placement of a tissue expander. The ADM is manipulated as necessary to accommodate the tissue expander, and then secured in place. Following the initial surgical phase, the tissue expander is filled over multiple postoperative visits to slowly expand the space under the pectoral muscle, creating the pocket. Once a pocket of sufficient size is formed, a second surgical procedure is performed, generally six months after the initial procedure, to remove the expander and insert a breast implant into the submuscular pocket created by the expander.

[0010] A more recent trend in breast reconstruction involves pre-pectoral placement of the implant on top of the pectoral muscle to avoid creating a submuscular pocket. During such procedures, the implant is generally completely encased in the ADM rather than using the ADM as a suspension device to only partially cover the implant.

[0011] It has been reported that the breast is shaped by a three-dimensional fibrofatty fascial system. Two layers of this system surround and fuse together around the breast body, anchoring it to the chest wall within a structure identified as the perimammary ligament (CML). The CML, which defines the breast periphery, is a 3D, roughly circular structure composed of collagen fibers of the superficial fascia, which encases a ring of fat and attaches it to the deep fascia of the chest as a circular adhesion zone. Summary of the Invention [Problem to be solved by the invention]

[0012] It is an object of the present disclosure to provide methods and prostheses for breast augmentation and / or reconstruction. [Means for solving the problem]

[0013] overview The present disclosure relates to methods and implantable prostheses for augmenting and / or reconstructing anatomical shape.

[0014] In one embodiment, an implantable prosthesis includes a body of biocompatible material having a proximal end and a distal end spaced from the proximal end. The body includes a hollow core structure extending along a core axis, a plurality of body segments attached to the hollow core structure, and a plurality of cavities formed by the plurality of body segments. The hollow core structure includes a proximal opening at its proximal end and a distal opening at its distal end. The body segments are circumferentially disposed about the hollow core structure, with each of the plurality of body segments extending in a radially outward direction away from the core axis. The cavities are disposed in a radially outward direction facing away from the hollow core structure.

[0015] In one embodiment, an implantable prosthesis includes a body having a biocompatible material in a three-dimensional form. The body includes a hollow core located along a core axis, a plurality of body segments circumferentially disposed about the hollow core, and a plurality of cavities formed by the plurality of body segments. The hollow core has a distal end and a proximal end, the distal end being closed to prevent access to the hollow core from the distal end, and the proximal end including an opening to allow access to the hollow core from the proximal end. Each of the plurality of body segments extends in a radially outward direction away from the core axis. The plurality of cavities face in a radially outward direction away from the hollow core.

[0016] In one embodiment, a method of fabricating an implantable prosthesis is provided that includes the acts of (a) attaching a plurality of body segments to a sheet of implantable biocompatible material; (b) after act (a), rolling the sheet into a tubular form to form a hollow core structure about a core axis, the plurality of body segments extending in a radially outward direction from the hollow core structure and being circumferentially disposed about the core axis; and (c) after act (b), securing the sheet in the tubular form.

[0017] In one embodiment, an implantable prosthesis includes a body having a biocompatible material in a three-dimensional form. The body includes a hollow core located along a core axis, a plurality of body segments circumferentially disposed about the hollow core, and a plurality of cavities formed by the plurality of body segments. Each of the plurality of body segments extends in a radially outward direction away from the core axis. Each body segment includes at least four body layers fabricated from a sheet of material, the sheet folded about a first fold and a second fold that crosses the first fold. The plurality of cavities face in a radially outward direction away from the hollow core.

[0018] In one embodiment, a method of fabricating an implantable prosthesis is provided that includes the acts of: (a) providing a plurality of sheets of biocompatible material; (b) folding one of the plurality of sheets along a first fold line and along a second fold line transverse to the first fold line to form a body segment including at least four body layers; (c) repeating act (b) for each of the plurality of sheets to form a plurality of body segments; and (d) circumferentially disposing the plurality of body segments about a core axis to form an implantable body having a three-dimensional configuration, the body layers forming a plurality of cavities facing in a radially outward direction away from the core axis.

[0019] In one embodiment, an implantable prosthesis includes a body having a biocompatible material in a three-dimensional form, the body having a proximal end and a distal end opposite the proximal end. The body includes a plurality of body segments located between the proximal and distal ends of the body and a plurality of cavities formed by the plurality of body segments. The plurality of body segments are circumferentially arranged about a longitudinal axis extending in a direction from the proximal end to the distal end. Each of the plurality of body segments extends in a radially outward direction away from the longitudinal axis and has an outer circumferential edge extending from the proximal end to the distal end of the body to define an outer contour of the body. The plurality of cavities face in a radially outward direction away from the longitudinal axis. The plurality of body segments include first and second body layers located between the proximal end and the longitudinal axis of the body and connected to each other at first and second connectors spaced apart from each other in an axial direction extending from the proximal end toward the distal end. The plurality of body segments further includes third and fourth body layers connected to the first and second body layers, the third body layer connected to the first body layer at a third connector located axially between the first connector and the second connector, and the fourth body layer connected to the second body layer at a fourth connector located axially between the first connector and the second connector.

[0020] In one embodiment, the implantable prosthesis includes a tissue-penetrating body of a biocompatible material having a proximal end and a distal end spaced from the proximal end, the body extending along a longitudinal axis from the proximal end to the distal end. The body includes a plurality of cavities arranged circumferentially about the longitudinal axis and extending in a radially outward direction facing away from the longitudinal axis. The plurality of cavities are arranged in a first tier, a second tier, and a third tier stacked along the longitudinal axis between the proximal end and the distal end. The second tier is located between the first tier and the third tier. Each of the first tier, the second tier, and the third tier includes at least a first and a second cavity. A first cavity in the first tier is aligned with a first cavity in the third tier along a first radial plane extending in a direction from the proximal end to the distal end of the body. The second cavities in the first tier are aligned with the second cavities in the third tier along a second radial plane extending in a direction from the proximal end to the distal end of the body. The first radial plane is circumferentially offset from the second radial plane. The cavities in the first tier have a first shape and the cavities in the third tier have a third shape, the first shape being different from the third shape.

[0021] In one embodiment, the implantable prosthesis includes a tissue-penetrating body of a biocompatible material having a proximal end and a distal end spaced from the proximal end, the body extending along a longitudinal axis from the proximal end to the distal end. The body includes a plurality of cavities arranged circumferentially about the longitudinal axis and extending in a radially outward direction facing away from the longitudinal axis. Each of the plurality of cavities extends along a corresponding cavity axis in a direction transverse to the longitudinal axis. The plurality of cavities are arranged in a first tier, a second tier, and a third tier stacked along the longitudinal axis between the proximal end and the distal end, the second tier being located between the first tier and the third tier. Each of the first tier, the second tier, and the third tier includes at least two cavities. The cavity axis of each cavity in the first tier has a first angle relative to the proximal end of the body, the cavity axis of each cavity in the second tier has a second angle relative to the proximal end of the body, and the cavity axis of each cavity in the third tier has a third angle relative to the proximal end of the body, the first, second and third angles being different from one another.

[0022] The above is a non-limiting summary of the present disclosure. Other aspects, embodiments and / or features will become apparent from the following description.

[0023] Various embodiments of the present disclosure may provide certain advantages and overcome certain shortcomings of prior art prostheses. Embodiments of the present disclosure may not share the same advantages, and those that do may not share the advantages under all circumstances.

[0024] Aspects of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0025] [Figure 1A] 1 is a schematic diagram of a breast reconstruction procedure. [Figure 1B] 1 is a schematic diagram of a breast reconstruction procedure. [Figure 1C] 1 is a schematic diagram of a breast reconstruction procedure. [Figure 1D] 1 is a schematic diagram of a breast reconstruction procedure. [Figure 1E] 1 is a schematic diagram of a breast reconstruction procedure. [Figure 1F] 1 is a schematic diagram of a breast reconstruction procedure. [Diagram 2] FIG. 1 is a top perspective view of an implantable prosthesis according to one embodiment. [Diagram 3] FIG. 3 is a side view of the implantable prosthesis of FIG. 2. [Figure 4] FIG. 3 is a top view of the implantable prosthesis of FIG. 2. [Diagram 5] FIG. 3 is a bottom view of the implantable prosthesis of FIG. 2. [Figure 6] FIG. 3 is a bottom perspective view of the implantable prosthesis of FIG. 2. [Figure 7] FIG. 1 is a top perspective view of an implantable prosthesis according to one embodiment. [Figure 8] FIG. 8 is a schematic diagram of the fabrication of the body of the implantable prosthesis of FIGS. 2-7, according to one embodiment. [Figure 9] FIG. 8 is a schematic diagram of the fabrication of the body of the implantable prosthesis of FIGS. 2-7, according to one embodiment. [Figure 10A] FIG. 10 is a schematic diagram of the fabrication of a body segment of the implantable prosthesis of FIGS. 2-9, according to one embodiment. [Figure 10B] FIG. 10 is a schematic diagram of the fabrication of a body segment of the implantable prosthesis of FIGS. 2-9, according to one embodiment. [Figure 10C] FIG. 10 is a schematic diagram of the fabrication of a body segment of the implantable prosthesis of FIGS. 2-9, according to one embodiment. [Figure 11] FIG. 1C is a schematic diagram of the fabricated body segment of FIGS. 10A-10C. [Figure 12] FIG. 1C is a schematic diagram of the fabricated body segment of FIGS. 10A-10C. [Figure 13] FIG. 1C is a schematic diagram of the fabricated body segment of FIGS. 10A-10C. [Figure 14] 1 is a perspective view of a body of an implantable prosthesis, illustrating generally the connections between body segments, according to one embodiment. [Figure 15]FIG. 1 is a perspective view of a body of an implantable prosthesis, illustrating generally a distal layer connected to a distal end of the body, according to one embodiment. [Figure 16] FIG. 16 is an enlarged view of FIG. 15 showing the connection between the tabs on the distal layer and the body of the implantable prosthesis. [Figure 17] 2-7 show the body of an implantable prosthesis in which the cavities are arranged in layers. [Figure 18] 2-7 show the body of an implantable prosthesis in which the cavities are arranged in layers. [Figure 19] FIG. 8 shows the body of the implantable prosthesis of FIGS. 2-7, with the cavity angled relative to the proximal end, according to one embodiment. [Figure 20] 8 illustrates the implantable prosthesis of FIGS. 2-7 covered with a shroud, according to one embodiment. [Figure 21] 1 illustrates a pre-shaped shroud according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] It should be understood that aspects of the present disclosure are described herein with reference to figures illustrating exemplary embodiments according to aspects of the present disclosure. The exemplary embodiments described herein are not necessarily intended to illustrate all aspects of the present disclosure, but are used to illustrate some exemplary embodiments. Therefore, the aspects of the present disclosure are not intended to be interpreted narrowly in view of the exemplary embodiments. Therefore, it should be understood that the various concepts and embodiments described herein can be implemented in any number of ways, as the disclosed concepts and embodiments are not limited to any particular implementation method. Furthermore, it should be understood that aspects of the present disclosure can be used alone or in any suitable combination with other aspects of the present disclosure.

[0027] Although the present disclosure relates to implantable prostheses for augmenting and / or reconstructing anatomical features, the prostheses may be suitable for correcting anatomical defects and weaknesses thereof in soft tissue and muscle walls or other anatomical regions. The phrase "correcting a defect" includes the act of repairing, supplementing, and / or reconstructing a defect and / or potential defect.

[0028] For ease of understanding, and without limiting the scope of the present disclosure, the prosthesis is described below with particular reference to breast reconstruction and / or augmentation. However, as will be apparent to one of ordinary skill in the art, it should be understood that the prosthesis is not so limited and may be used in other anatomical procedures. For example, but not limited to, the prosthesis or aspects of the prosthesis may be used in hernias, chest or abdominal wall reconstructions, or large defects such as those that may occur in overweight patients. The prosthesis may include one or more features, each contributing independently or in combination to such qualities.

[0029] As will be further described below, the prosthesis may have particular application with pre-pectoral breast reconstruction procedures.

[0030] Prepectoral breast reconstruction 1A-1F illustrate one embodiment of a pre-pectoral breast reconstruction procedure.

[0031] As shown in Figure 1A, an initial incision 200 is made to create a tissue flap in the lower part of the breast. As shown in Figure 1B, the flap 202 may be widened to provide access to the breast tissue and allow removal of a tumor or other growth. It is desirable to preserve the skin and nipple areola.

[0032] As shown in Figure 1C, the breast body 204 is removed along with the base of Cooper's ligament. The cinchomammary ligament (CML) is then tightened to re-establish the base of the desired diameter of the breast, as shown in Figure 1D. For example, the CML may be tightened to correspond to the base of the pre-operative diameter of the breast, or may be tightened more if the CML has stretched and loosened over time due to aging and / or other factors.

[0033] As shown, the CML may be tightened using a purse string technique, where a running suture 206 is placed around and / or through the CML and then pulled upwardly to securely grasp the tissue upwardly and tighten the base, however, other procedures are contemplated for re-establishing the breast base.

[0034] Once the CML is tightened, the prosthetic implant 208 may be inserted into the breast cavity created by removing the breast body, as shown in FIG. IE. Prior to insertion, the implant may be coated with fat graft aspirated from the patient. The fat graft may help soften the prosthesis and / or provide a base for new fat and / or tissue to form in and around the prosthesis. The fat graft also reduces the likelihood of fluid filling the space created by the removal of tissue during the procedure.

[0035] Fat grafts may be harvested from the patient using standard liposuction techniques. The aspirated fat may be processed in situ to remove oils and provide a more refined fat for the procedure. The processed fat may be applied to the various surfaces and into the various cavities of the prosthesis using a syringe or similar device, although other techniques for coating the prosthesis are also contemplated.

[0036] Once inserted, the implant may be secured to the CML using sutures or other fasteners placed along the base of the device. After implantation of the prosthesis, the incision 200 may be closed without tension, as shown in FIG. 1F.

[0037] After the initial reconstructive procedure, additional fat grafting into the breasts may be performed over time by one or more procedures to achieve the desired shape and / or feel of the breasts and / or symmetry between the breasts.

[0038] Prosthesis and Fabrication Concept The present disclosure relates more particularly to a prosthesis for reconstructing and / or augmenting an anatomical shape. According to one aspect, an implantable prosthesis may have a three-dimensional form for reconstructing and / or augmenting the anatomical shape of a human breast. The prosthesis may be configured to encourage ingrowth of fat and / or tissue to fill the void space within and around the prosthesis. The prosthesis may use a body structure with multiple cavities to allow fat and / or tissue to fill and pass through the body structure and to bulge the anatomical shape of the reconstructed and / or augmented breast. The overall desired structure of the prosthesis may use a variety of structures for its fabrication in an efficient manner.

[0039] According to one aspect, the prosthesis may be fabricated using multiple segments that may be arranged to create a desired shape of the prosthesis. In this manner, individual segments may be fabricated in a relatively uncomplicated manner and then assembled to create a desired cavity in the prosthesis. The segments may also be configured to provide the prosthesis with a desired amount of resilience and support.

[0040] According to one embodiment, the implantable prosthesis may include multiple layers of material joined together to create a desired overall shape of the prosthesis. The layers may include one or more three-dimensional layers or structures that may be joined directly to each other or to adjacent two-dimensional layers of material. Each three-dimensional layer or structure may include multiple cavities, such as three-dimensional cavities for receiving fat and / or tissue.

[0041] According to one aspect, the prosthesis may employ one or more body segments configured to expand into a 3D structure having a desired cavity during fabrication of the prosthesis. For example, but not limited to, the body segments may include multiple layers of material that are folded and / or joined together such that expansion of each segment pulls the folds and / or layers apart to form a 3D cavity for receiving fat and / or tissue. The expanded body segments may be joined in any suitable pattern to form a cavity having a desired shape, size and / or configuration. The body segments may be configured to form a body structure having a pleated, honeycomb-like or other suitable 3D structure that provides a tissue and / or fat receiving cavity upon expansion.

[0042] According to one aspect, each of the body segments may be connected to an adjacent body segment to form a cavity.

[0043] According to one aspect, the distal material layer may be attached to a distal end of the body structure. The distal layer may be attached to one or more of the body segments. The body may include a hollow core. In some applications, the distal layer may cover a distal opening of the hollow core to prevent access to the hollow core from its distal end. In some applications, the distal layer may include an opening therethrough that is aligned with and allows access to the distal opening of the hollow core. The distal layer may have an annular configuration. In breast reconstruction and / or augmentation, the distal layer may be positioned to underlie and support the nipple and / or areola of the breast.

[0044] According to one aspect, a proximal layer of material may be attached to a proximal end of the body opposite the distal end. The proximal layer may have an opening therethrough that is aligned with a proximal opening of the hollow core to allow access to the hollow core through the proximal layer. The proximal layer may have an annular configuration. The proximal layer may be attached to one or more of the body segments. In breast reconstruction and / or augmentation, the proximal layer may be positioned against the chest wall.

[0045] According to one aspect, each body segment may include a plurality of body layers extending in a radially outward direction away from the core axis. Each body segment may include a plurality of pairs of body layers bonded together. The body layers of each pair of body layers may be bonded together.

[0046] According to one aspect, the body may have a frustoconical or hemispherical shape.

[0047] According to one embodiment, the body may be formed of a resorbable material. For example, but not limited to, the body may be formed of P4HB (poly-4-hydroxybutyrate).

[0048] According to one aspect, the body can be tissue-permeable. The body can be formed of a mesh fabric, and the mesh fabric can be tissue-permeable.

[0049] According to one aspect, the prosthesis may include multiple tiers or rows of cavities that are stacked on top of one another to create a desired arrangement of cavities.

[0050] Each level may include cavities having the same shape, size, relative position and / or relative orientation. The cavities in one level may differ in shape, size, position and / or orientation from the cavities in another level. Each level may have a different size and / or shape relative to another level.

[0051] Each level can include cavities having the same angle relative to the proximal end of the body. The cavities in one level can be angled differently relative to the proximal end of the body as compared to another level.

[0052] In some applications, the prosthesis may have a configuration that may be trimmed, for example, by a surgeon to create a desired shape for implantation. For example, but not limited to, one or more layers and / or individual structures of the prosthesis may be trimmed to create a customized implant shape.

[0053] According to one aspect, the prosthesis may include a proximal surface for placement in the pectoral muscle. The proximal surface may be planar or may have a generally rounded shape, such as, but not limited to, a convex shape. Such a configuration may facilitate positioning and placement of the prosthesis in the pectoral muscle and within the perimammary ligament, thereby establishing the location of the prosthesis on the chest wall. In this manner, the interaction between the implant and the anatomical structure may create a ball-and-socket like arrangement.

[0054] According to one embodiment, the prosthesis may include an outer shroud for covering the 3D body structure. The shroud may include a fabric layer that may be placed over and attached to the body structure. Optionally, the shroud may have a preformed 3D shape that corresponds to the contour of the body. The shroud may cover the edges of the body segments to soften the interface with the anterior tissue flap. The shroud may encourage rapid ingrowth to form a continuous layer of vascularized, collagenized fibrous tissue that may support and encourage the proliferation of an adipose tissue layer above the prosthesis.

[0055] A variety of structural arrangements and / or manufacturing techniques may be used to fabricate relatively complex implants.

[0056] 2-6, the prosthesis 20 may include a body 22 configured to reconstruct and / or augment an anatomical shape. The body 22 may be configured to support tissue and / or fat growth as part of the reconstruction and / or augmentation.

[0057] In one embodiment, the body 22 may be formed in a three-dimensional form to reconstruct and / or augment the anatomical shape of a human breast. For example, without limitation, the prosthesis may have a generally frustoconical or hemispherical shape with a relatively larger proximal or inferior end positioned adjacent the patient's pectoral muscle and a relatively smaller distal or superior end opposite the inferior end. The outer dimensions of at least a portion of the body of the prosthesis may generally decrease in a direction from the proximal or inferior end 24 toward the distal or superior end 26 of the prosthesis. Optionally, the outer dimensions of the portion of the body may initially be constant before decreasing toward the distal end.

[0058] The outer contour of the body is contoured by one or more segments to impart the desired configuration of the prosthesis. In one embodiment, the outer contour may be defined by multiple straight segments that are differently oriented relative to one another. In other embodiments, the outer contour of the body may be defined by a single curved segment, either convex or concave, multiple curved segments, a single straight segment, or a combination of curved and straight segments, as would be apparent to one of ordinary skill in the art, to achieve the desired configuration.

[0059] In one exemplary embodiment shown in Figures 5-6, the body may include a core 28 that extends along the core axis 30 of the prosthesis. In some applications, it may be desirable to use a hollow core. For example, but not limited to, a hollow core allows fat and / or tissue to fill and pass through the body of the prosthesis. In another non-limiting example, a surgeon may pull a vascularized flap pedicle along with blood vessels into one end of the hollow core.

[0060] According to one aspect, the core axis 30 may extend along the center of the body 22, with the hollow core centrally located within the body. In one embodiment, the body may employ a configuration that is symmetrical about the core axis. However, it should be understood that the body may employ an asymmetric configuration, as would be apparent to one of ordinary skill in the art.

[0061] According to one aspect, the core 28 may include a tubular structure having walls 32 that define a hollow core. Such an arrangement may provide the prosthesis with a desired amount of column strength to support the anatomical space being augmented or reconstructed. In one embodiment, the core 28 may be formed from a sheet of material that is rolled or otherwise shaped into a tubular form. However, as will be apparent to one of skill in the art, the hollow core may be formed in any suitable manner. For example, but not limited to, the core may utilize a length of prefabricated tubular material having a diameter suitable for a particular application.

[0062] In some applications, it may be desirable to provide one or more features to facilitate placement and / or attachment of the prosthesis at the surgical site. In one exemplary embodiment shown in Figures 2-6, the prosthesis includes a proximal layer or base 34 coupled to the proximal or lower end 24 of the body to facilitate placement and attachment of the prosthesis within the breast cavity. For example, without limitation, the base may be configured to provide support for attaching the prosthesis in place to the CML and / or adjacent tissue or muscle.

[0063] The proximal layer or base 34 may be configured to have any suitable shape and / or size conducive to positioning and / or fixation of the prosthesis to adjacent tissue. For example, without limitation, the base 34 may have a planar or non-planar configuration that corresponds to the surgical site and / or is suitable for the particular procedure being used for reconstruction. In one embodiment, the base may be configured with a contoured shape to facilitate positioning and contact with adjacent tissue. For example, without limitation, the base may have a curved profile, such as a convexly curved outer surface configured to fit within the CML, such as a ball and socket type arrangement. However, it should be understood that the base may use any suitable shape, either planar or non-planar, as would be apparent to one of skill in the art.

[0064] The base 34 may be configured to be grasped and manipulated to position the prosthesis. One or more fasteners, such as, but not limited to, sutures, tacks, and staples, may be used to attach the base to the underlying muscle and / or tissue. The base may be formed from a layer of biocompatible material, such as a material for use in the body of the prosthesis.

[0065] In some applications, base 34 may include a number of gripping portions (not shown) protruding from its underside that are configured to penetrate and securely grasp adjacent tissue and / or muscle to facilitate positioning and / or fixation of the prosthesis.

[0066] In some applications, the base may include a support to help hold the base in the open, expanded configuration. For example, without limitation, the support may include an elastic ring extending around the base at or near the outer periphery of the base. The support may be formed of a resorbable material so that it is resorbed by the body over time, although if desired, the support may be formed of a non-resorbable material. In one embodiment, the support may be formed of a resorbable material and surrounded by a containment sleeve configured to contain the support as it degrades during resorption.

[0067] In some applications, it may be desirable to access the core 28 of the prosthesis. According to one aspect, at the proximal or lower end 24 of the body, the proximal end of the core may include a proximal core opening 35 to allow access to the hollow core. In one embodiment, the proximal layer or base 34 may have an annular configuration with an inner opening 36 aligned with the proximal core opening 35 and / or the core axis 30 of the core. As shown in FIGS. 5-6, the inner opening 36 of the base may be larger than the core 28 so that the proximal or lower portion of the body located radially outward of the core may be exposed to adjacent tissue when the prosthesis is implanted. However, it should be understood that the base opening may have the same size as the core or may be smaller, if desired.

[0068] Additionally or alternatively, the prosthesis may include a distal or upper layer 38 of material coupled to the distal or upper end 26 of the body opposite the proximal or lower end. The distal layer 38 may be configured to conform to the areola and / or nipple area of ​​the breast when positioned within the breast cavity. The distal layer may be configured to support the areola and / or nipple of the breast, if present, when positioned within the breast cavity.

[0069] In one embodiment shown in Figure 4, the distal layer 38 may be configured at the distal or upper end 26 of the body to completely cover the distal end of the core, closing the hollow core 28 and preventing access from the distal end 26 of the prosthesis. Such a configuration may be desirable for positioning under and supporting the areola and nipple of the breast. However, if desired, the distal material layer may be provided with an opening therethrough that is positioned to align with the distal core opening and provide access to the core from the distal or upper end of the prosthesis.

[0070] In one embodiment shown in Figure 7, the distal layer 38 may have an annular configuration with an inner opening 39 aligned with the distal core opening and / or the core axis 30 of the core. As shown, the inner opening 39 of the distal layer may be larger than the core 28 so that a distal or upper portion of the body radially outside the core may be exposed to adjacent tissue when the prosthesis is implanted. However, it should be understood that the distal layer opening may have the same size as the core or may be smaller, if desired.

[0071] As mentioned above, the body 22 may be configured to support tissue and / or fat growth as part of the anatomical reconstruction. In one exemplary embodiment shown in Figures 2-7, the body 22 may include a plurality of outwardly directed cavities 40 disposed about the core axis 30 and surrounding the core 28. The cavities may be sized, shaped, positioned, or otherwise configured to allow fat and / or tissue to fill and pass through the structure and to full out the reconstructed and / or augmented breast. In some applications, it may be desirable, but not required, to place a selected amount of fat into the cavities prior to implantation of the prosthesis.

[0072] According to one aspect, the prosthesis body 22 may include a plurality of body segments 42 arranged to create a cavity of a desired configuration. In one embodiment shown in FIGS. 2-7, the body segments 42 may be circumferentially arranged around the core 28 and extend in a radially outward direction from the core to form a petal-like configuration. The body segments 42 may be attached together and / or to the core 28 to maintain the position of the body segments and / or contribute to the structural integrity of the prosthesis. In this regard, as will be apparent to one of ordinary skill in the art, the body segments 42 may be attached together and / or to the core 28 using any suitable technique. However, it should be understood that for some embodiments, the body segments need not be attached to a hollow core structure. For example, the body may not include a hollow core structure, and the body segments may be attached to one another around and spaced apart from the core axis to form a hollow core.

[0073] In one embodiment shown in Figures 8-9, each body segment 42 may have an outer periphery 44 extending from a proximal or lower end to a distal or upper end. The proximal and distal ends may correspond to the proximal and distal ends of the body. Each body segment may include an inner periphery 46 positioned along the core 28, a proximal or lower periphery 48 positioned at the proximal end 24 of the body, and a distal or upper periphery 50 positioned at the distal end 26 of the body. The outer periphery 44 extends from the proximal periphery 48 to the distal periphery 50 of the body segment and may have any suitable form to form the desired shape of the prosthesis.

[0074] In one embodiment, an inner peripheral edge 46 of each body segment may be secured to the core with an outer peripheral edge 44 radially spaced from the core.

[0075] 8, the core 28 may be formed from a sheet or layer 52 of material. The body segments 42 may be attached to the core material at spaced apart locations relative to one another. As shown, each body segment 42 may be positioned with its inner periphery 46 extending the length of the sheet of core material.

[0076] 9, after the body segments 42 are attached to the sheet of core material 52, the sheet 52 may be rolled into a tube form about the core axis 30 such that the body segments 42 are arranged in a fan-like arrangement about the core axis 30 with each body segment extending in a radially outward direction away from the core. Opposite ends 54, 56 of the sheet of core material may be overlapped and secured together to maintain the sheet in the tube form to form a hollow core structure.

[0077] The body segments 42 may be attached to a sheet 52 of core material, and the overlapping ends 54, 56 of the core material may be secured together at one or more locations. In one embodiment, four connections 58, e.g., ultrasonic welds, may be used to attach each body segment to the core material and the opposing ends of the core material together. The opposing ends of the core material may be overlapped and connected to one another. However, it should be understood that any number of welds may be used to achieve the desired level of attachment. Additionally, it should be understood that the body segments and / or core material may be secured using any suitable fastening technique, as would be apparent to one of ordinary skill in the art.

[0078] According to one aspect of the present disclosure, each body segment 42 may include multiple layers of material. The multiple layers of material may be formed as unitary structures or modules that are connected to the core. Such an arrangement may facilitate fabrication of the prosthesis by reducing the number of separate components that need to be individually attached to the core. However, if desired, individual layers of material may be separately attached to the core, as would be apparent to one of ordinary skill in the art.

[0079] In one exemplary embodiment, each body segment 42 may include multiple body layers joined together as a unitary structure. In one embodiment shown in Figures 10A-13, each body segment 42 may include four body layers 54 attached to the core 28 and extending in a radially outward direction. The body layers 54 for each body segment 42 may be arranged in two pairs of body layers 55a, 55b, with each layer 54 of a layer pair joined to one another along their radially extending proximal peripheries 48. The body layers of each body segment may also be joined to one another along their inner peripheries 46 that extend axially along the length of the core.

[0080] In one exemplary embodiment shown in Figures 10A-11, each body segment 42 may be formed from a single sheet of material 56 that is folded about a first axis 58 and a second axis 60 to form four body layers. As shown in Figure 10A, the sheet of material may be folded about the first axis 58 along a first fold line 62 to form a proximal perimeter 48 joining each pair of body layers. As shown in Figure 10B, the sheet of material 56 may then be folded about the second axis 60 along a second fold line 64 to form an inner perimeter 46 of the body layers. The second fold line 64 divides the first fold line 62 into first and second fold segments 62a, 62b. In one embodiment, the first and second fold lines 62, 64 may be perpendicular to one another. However, as will be apparent to one skilled in the art, the sheet of material 56 may be folded along any number of creases oriented at any desired angle relative to one another to form body segments having any suitable configuration and / or number of body layers.

[0081] As discussed above, the outer contour of the body 22 may be contoured to create the desired configuration of the prosthesis. In one embodiment shown in Figure 10A, the sheet of material forming the body segment may have an octagonal shape, with each quadrant of the sheet forming one of the body layers of the body segment. As shown in Figure 10C, the octagonal sheet results in each body layer having a periphery 44 having a first segment 44a, a second segment 44b, and a third segment 44c, which extends from the proximal end to the distal end of the body segment.

[0082] In one embodiment, the first segment 44a may be configured to extend a desired length in a direction parallel to the core axis 30, and the third segment 44c may be positioned to extend a desired length in a direction transverse to the first segment 44a and the core axis 30. The second segment 44b may be positioned to extend from the first segment 44a to the third segment 44c at an angle that is non-parallel and non-perpendicular to both the first and third segments. In this manner, the outer dimension of the first segment 44a may be constant relative to the inner periphery 46 in a direction from the proximal end toward the second segment 44b, and the second segment may be angled such that its outer dimension decreases from the first segment 44a toward the third segment 44c, which is located at the distal end 26 of the body.

[0083] In one embodiment, the third segment 44c may be disposed perpendicular to the first segment 44a, and the second segment 44b may be disposed at an angle of 35° to 40° relative to the proximal end 24 of the body segment. As will be apparent to one skilled in the art, it is understood that the size and configuration of the sheets may be selected to form body segments having body layers of any size and shape suitable for forming the body of a prosthesis. It is also understood that sheets of different sizes and / or configurations may be used to form bodies having different sizes and configurations.

[0084] 10A-13, tabs 66 may extend from one or more of the body layer third segments 44c of each body segment. As described further below, the tabs 66 may be used to attach the distal layer 38 to the body. However, it should be understood that tabs are not required in each embodiment and / or the number of tabs may vary depending on the particular configuration of an embodiment.

[0085] The cavity 40 in the body 22 may be formed by bonding adjacent body layers 54 together to form a cavity of the desired configuration.

[0086] 14, the body segment 42 may include first and second body layers 54a, 54b connected to one another at first and second junctures 70, 72 located between the proximal and distal ends 24, 26 of the body 22. The first and second junctures 70, 72 may be spaced apart from the core axis 30 and spaced apart in a proximal-to-distal direction extending from the proximal end toward the distal end of the body. In one embodiment, the second juncture 72 may be located in close proximity to the distal end 26 of the body.

[0087] The body segment may also include third and fourth body layers 54c, 54d connected to the first and second body layers 54a, 54b. In one embodiment, the third body layer 54c may be connected to the first body layer 54a at a third connector 74 located between the first connector 70 and the second connector 72 in the proximal to distal direction. The fourth body layer 54d may be connected to the second body layer 54b at a fourth connector 76 located between the first connector 70 and the second connector 72 in the proximal to distal direction.

[0088] In one embodiment, as shown in Figure 14, each of the first, second, third and fourth connections may be located adjacent the outer periphery of a respective body layer. In one embodiment, the first, second, third and fourth connections are the only connections located between the proximal and distal ends of the body and between adjacent body layers. However, it should be understood that any number of connections may be used between body layers and located anywhere along the body layers to form a body having cavities in any suitable arrangement, as would be apparent to one skilled in the art.

[0089] The first and third body layers 54a, 54c may be further connected together at the body proximal end 24, and the second and fourth body layers 54b, 54d may be further connected together at the body proximal end 24. In one embodiment, the first and third body layers 54a, 54c may be connected together along a first fold segment 62a, and the second and fourth body layers 54b, 54d may be connected together along a second fold segment 62b. As shown, each fold segment 62a, 62b may be oriented to extend in a radially outward direction away from the core axis toward the outer circumferential edge of the body layer.

[0090] The density and / or size of the cavities may be varied by the number and / or spacing of the connections between layers. For example, placing the connections closer together may form relatively small, denser cavities, and spacing the connections further apart may form relatively larger, less dense cavities. If desired, the body structure may include regions having cavities of different sizes and / or densities by varying the pattern of connections between various material layers.

[0091] In one embodiment, the body layers 54 may be connected together using welded connections, such as ultrasonic spot welds, however, it should be understood that the body layers may be connected using any suitable fastening or joining technique, such as, but not limited to, sutures, staples, and tacks, as would be apparent to one skilled in the art.

[0092] As discussed above, the implantable prosthesis may include a proximal layer 34 attached to the proximal end 24 of the body. In one embodiment shown in Figures 5 and 6, the proximal layer 34 may be attached to each of the first and second fold segments 62a, 62b. As shown, the proximal layer may be attached to the fold segments by a pair of connections 58, such as ultrasonic spot welds. However, it should be understood that the proximal layer may be connected to the body using any suitable fastening or joining technique, such as, but not limited to, sutures, staples, and tacks, as would be apparent to one skilled in the art.

[0093] The implantable prosthesis may include a distal layer 38 attached to the distal end 26 of the body. In one embodiment shown in Figures 15-16, the distal layer 38 may be attached to respective tabs 66 on the body segment. As shown, the distal layer may be attached to the tabs by connections 58, such as ultrasonic spot welds. However, it should be understood that the distal layer may be connected to the tabs using any suitable fastening or joining technique, such as, but not limited to, sutures, staples, and tacks, as would be apparent to one skilled in the art.

[0094] In some applications, it may be desirable to arrange the cavities in multiple tiers along the core axis. In one exemplary embodiment shown in Figures 17-18, the cavities 40 may be arranged in a first tier T1, a second tier T2, and a third tier T3 stacked along the core axis 30 between the proximal end 24 and the distal end 26 of the body. The second tier T2 may be located between the first tier T1 and the third tier T3. As shown in Figure 18, each tier may include at least a first cavity 40a-1, 40b-1, 40c-1 and a second cavity 40a-2, 40b-2, and 40c-2.

[0095] 18, a first cavity 40a-1 in the first story T1 may be aligned with a first cavity 40c-1 in the third story T3 along a first radial plane P1 extending in a direction from the proximal end to the distal end of the body. A second cavity 40a-2 in the first story T1 may be aligned with a second cavity 40c-2 in the third story T3 along a second radial plane P2 extending in a direction from the proximal end to the distal end of the body. The first radial plane may be circumferentially offset from the second radial plane.

[0096] In one embodiment, the cavity 40b in the second story T2 may be circumferentially offset from the cavities 40a, 40c in the first and third stories T1, T3. As shown in Figures 17-18, the cavity 40b in the second story may separate the cavity 40a in the first story from the cavity 40c in the third story.

[0097] In one embodiment, each tier may include cavities having the same shape in the corresponding tier. In one embodiment, the cavities in the first tier T1 may have a first shape and the cavities in the third tier T3 may have a third shape different from the first shape. The cavities in the second tier T2 may have a second shape different from the first and / or third shapes. However, it should be understood that the cavities may have the same or different shapes within each tier and / or between tiers.

[0098] 17-18, each cavity 40a in the first level T1 can include a periphery having a first portion 80 having a chevron shape and a second portion 82 having a curved shape. As shown, the second portion 82 of the periphery can have a concave curvature extending in a direction from the first portion 80 toward the distal end of the body. The first portion 80 of the periphery can be at least partially located between adjacent cavities in the second level T2.

[0099] In one exemplary embodiment shown in Figures 17-18, the cavity 40 may decrease in size from the proximal end 24 to the distal end 26 of the body in the direction of the core axis 30. Each of the first, second and third levels of the cavity may have an outer diameter that decreases in the direction from the proximal end to the distal end. In one embodiment, the third level T3 may have an outer diameter that is smaller than the outer diameter of the first level T1. The second level T2 may have an outer diameter that is smaller than the outer diameter of the third level T3.

[0100] In one embodiment, the cavities provided in each tier may have the same size in the corresponding tier. Each cavity within a tier may increase in size in a radially outward direction away from the core axis toward the outer periphery of the body. In one embodiment, each cavity may have an increasing width in a radially outward direction. It should be understood that the cavities in each tier may be configured to have different sizes, as would be apparent to one of ordinary skill in the art.

[0101] Each of the cavities 40 may extend along a corresponding cavity axis CA in a direction transverse to the core axis 30. The cavity axis CA extends along a length of the cavity 40 and is located approximately in a central region of the cavity. In one embodiment, the cavity axis for each of the cavities may be different relative to each other cavity. Each cavity axis may be oriented in a different direction relative to each other cavity. Each cavity axis may be angled relative to the body proximal end 24.

[0102] As shown in FIG. 19, the cavity axis CA1 of each cavity 40a in the first story T1 may have a first angle A1, the cavity axis CA2 of each cavity 40b in the second story T2 may have a second angle A2, and the cavity axis CA3 of each cavity 40c in the third story T3 may have a third angle A3. In one embodiment, the first, second, and third angles may be different from each other. For example, but not limited to, the first angle A1 may be smaller than the second angle A2 and / or the third angle A3, and the second angle A2 may be smaller than the third angle A3. However, it should be understood that the first, second, and third angles may be the same angle, or any two of the first, second, and third angles may be the same, and the remaining angle may be different from the other two angles.

[0103] In one embodiment, the first angle A1 of the cavity axis CA1 may be the same for each cavity 40a in the first story T1. The second angle A2 of the cavity axis CA2 may be the same for each cavity 40b in the second story T2. The third angle A3 of the cavity axis CA3 is the same for each cavity 40c in the third story T3. However, it should be understood that the cavity axes of the cavities in each story need not have the same angle with respect to each other, and the angles of the cavity axes may be different in corresponding stories.

[0104] The body 22 of the prosthesis may be configured to have any desired shape that may be suitable for a particular application. In one exemplary embodiment as shown in the drawings, the body may have a frusto-conical shape that may be suitable for breast reconstruction and / or augmentation. Examples of other suitable shapes may include, but are not limited to, spherical, hemispherical, and tubular shapes. As shown, the body may have a planar configuration at the proximal end 24 and / or distal end 26. However, one or both of the proximal and distal ends may employ a non-planar configuration, such as, but not limited to, a curved configuration. For example, but not limited to, the proximal and / or distal ends may have a concave or convex shape.

[0105] In some applications, when used in prepectoral implant breast reconstruction or augmentation, it may be desirable to soften the interface between the body 22 of the prosthesis and adjacent tissue, such as an anterior tissue flap. In one exemplary embodiment shown in FIG. 20, a shroud 90 may be provided to cover the outer contour of the body. In one embodiment, the shroud 90 may include a flexible sheet of biocompatible material that is placed over the body 22 and secured to at least the base 34 of the prosthesis. In one embodiment shown in FIG. 21, the shroud 90 may be preformed into a three-dimensional shape that fits over and corresponds to the body. For example, but not limited to, the shroud may be configured with a dome-like shape that may be secured to the base. In this manner, the shroud may cover the edges of the petals and / or body segments to soften their interface with adjacent tissue. The shroud may provide the prosthesis with a relatively smooth outer surface.

[0106] The shroud 90 may include a flexible mesh fabric that supports tissue ingrowth to create a continuous layer of vascularized, collagenized fibrous tissue over the entire anterior contour of the prosthesis, thereby supporting and encouraging the proliferation of an adipose tissue layer above the prosthesis. In addition to softening the interface between the edges of the prosthesis, particularly the petals and / or body segments, the shroud may reduce the need for autologous fat grafting (AFT) and / or increase the additional volume created by AFT. The shroud may prevent the prosthesis from being recognized sooner than a prosthesis without the shroud would be. The shroud may retain grafted fat on the outer surface of the prosthesis and increase fat survival. The combined effect of softening the edges and encouraging lipogenesis may reduce the need for postoperative autologous fat grafting. However, it should be understood that a shroud is not required for every embodiment of the prosthesis.

[0107] For breast reconstruction or augmentation, it may be desirable to provide a durable, lightweight implantable prosthesis without long-term foreign body concerns.

[0108] According to one aspect, the prosthesis may be made from a resorbable material. In one embodiment, the prosthesis may be made from a slowly resorbing material, such as P4HB (poly-4-hydroxybutyrate), to provide long-term support to the breast and promote a more natural look and feel of the breast as fat and / or tissue eventually fills and replaces the prosthesis. The material may be sufficiently porous to promote the passage of fat and / or tissue ingrowth within the prosthesis, although porous materials are not required for every embodiment. The prosthesis may include knitted, woven, and / or non-woven materials.

[0109] In one embodiment, the prosthesis, including the body and shroud, if used, may be fabricated from PHASIX mesh (available from Davol, Inc., Warwick, RI) manufactured from P4HB. Other suitable materials may include, but are not limited to, GalaFLEX (available from Galatea), TIGR Matrix (available from Novus Scientific), SERI Surgical Body (available from Allergen), BIO-A (available from Gore), and ULTRAPRO (available from Ethicon). If desired, as an alternative, a non-woven material, such as Phasix, may be used or may be used in conjunction with the mesh to provide a relatively soft contour to the prosthesis. In some applications, it may be desirable to fabricate the prosthesis or one or more portions of the prosthesis from a non-absorbable material, such as, but not limited to, polypropylene and polytetrafluoroethylene (PTFE).

[0110] For embodiments using a shroud formed over the body using a flat sheet of repair fabric, it may be desirable to use a fabric that is relatively stretchable as compared to a shroud that is pre-shaped as a dome. For example, but not by way of limitation, it may be desirable to use a fabric that has approximately 50% more stretch than the material used to pre-shape the shroud as a dome. In one embodiment, GalaFlexLITE may be used to form the shroud over and around the body. However, it should be understood that other stretchable materials may be used to form the shroud, as would be apparent to one of ordinary skill in the art.

[0111] In some applications, it may be desirable to coat the prosthesis with a material that provides one or more properties. For example, but not limited to, it may be desirable to minimize bleeding, minimize seroma formation, and / or encourage tissue ingrowth. In one embodiment, the prosthesis may be coated with Arista AH (available from Davol, Inc.).

[0112] For a particular application of the prosthesis, it may be desirable to construct it to provide a desired amount of resistance to permanent deformation after compression. In one embodiment, the prosthesis may be constructed to have a reduced height or have 10% or less (i.e., ≦10%) of its original height H after being subjected to a vertical compression of 40% of its height H. The reduction in height may be determined by one or more subsequent compressions. In one embodiment, the reduction in height may be determined at time t=0 and at time t=12 weeks. However, it should be understood that the prosthesis may be configured to provide any suitable amount of resistance to permanent deformation, as would be apparent to one of skill in the art.

[0113] During healing and implant integration, it may be desirable to provide an implantable prosthesis that can support the resected space together with the grafted adipose tissue.

[0114] According to one aspect, the prosthesis may have a compressive strength to resist biomechanical forces within the breast. In one embodiment, the implant may have a compressive strength of at least 3.1 lbf (i.e., ≧3.1 lbf) at 25% vertical compression at time t=0 and at least 2.4 lbf (i.e., ≧2.4 lbf) at 25% vertical compression at time t=12 weeks. However, it should be understood that the prosthesis may be configured to have any suitable amount of compressive strength, as would be understood by one of ordinary skill in the art.

[0115] According to one aspect, the prosthesis may use connections that have sufficient connection strength to maintain the mechanical integrity of the device. In one embodiment, the implant may use connections that have a connection strength of at least 1.0 lbf (i.e., ≧1.0 lbf) at time t=0. However, it should be understood that the prosthesis may be configured to have any suitable amount of connection strength, as would be understood by one of ordinary skill in the art.

[0116] For purposes of this patent application and any patents thereon, the indefinite articles "a" and "an" as used in the specification and claims shall be understood to mean "at least one" unless expressly stated otherwise. The term "and / or" as used in the specification and claims shall be understood to mean "either or both" of the elements so coordinated, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and / or" shall be considered in the same manner, i.e., "one or more" of the elements so coordinated. Other elements, whether associated or not with the elements specifically identified, may optionally be present other than the elements specifically identified by the "and / or" clause.

[0117] As used herein, the use of "comprises," "includes," "has," "containing," "involving," and / or variations thereof is meant to include the items listed before it and equivalents thereof as well as additional items.

[0118] It should also be understood that, unless expressly stated otherwise, in any method claimed herein that includes two or more steps or actions, the order of the method steps or actions is not necessarily limited to the order in which the method steps or actions are recited.

[0119] The above description of various embodiments is intended to be merely illustrative; other embodiments, modifications, and equivalents are within the scope of the disclosure.

Claims

1. A transplantable prosthesis, comprising a body of biocompatible material having a proximal end and a distal end spaced from the proximal end, a hollow core structure extending along a core axis and including a proximal opening at its proximal end and a distal opening at its distal end; a plurality of body segments attached to the hollow core structure and circumferentially arranged around the hollow core structure, each of the plurality of body segments extending in a radially outward direction away from the core axis; and a plurality of cavities formed by the plurality of body segments and arranged in the radially outward direction facing away from the hollow core structure and a body comprising a transplantable prosthesis.

2. The transplantable prosthesis according to claim 1, wherein each of the plurality of body segments is connected to an adjacent body segment to form the plurality of cavities.

3. The transplantable prosthesis according to claim 1, further comprising a distal material layer attached to the distal end of the body.

4. The transplantable prosthesis according to claim 3, wherein the distal layer is attached to one or more of the body segments.

5. The transplantable prosthesis according to claim 4, wherein the distal layer covers the distal opening of the hollow core to prevent access to the hollow core from its distal end.

6. The transplantable prosthesis according to claim 4, wherein the distal layer includes an opening therethrough, and the opening is aligned with the distal opening of the hollow core.

7. The transplantable prosthesis according to claim 6, wherein the opening in the distal layer is larger than the distal opening of the hollow core.

8. The transplantable prosthesis according to claim 6, wherein the distal layer has an annular form.

9. The transplantable prosthesis according to claim 3, further comprising a proximal material layer attached to the proximal end of the body opposite the distal end, the proximal layer having an opening therethrough, the opening being aligned with the proximal opening of the hollow core to allow access to the hollow core through the proximal layer.

10. The opening in the proximal layer is larger than the proximal opening of the hollow core, the proximal layer has an annular shape, and the proximal layer is attached to one or more of the body segments, the implantable prosthesis according to claim 9.

11. Each body segment includes a plurality of body layers extending in a radially outward direction away from the core axis, each body segment includes a plurality of pairs of body layers joined together, and the body layers of each pair of body layers are joined together, the implantable prosthesis according to claim 1.

12. The body has a frustum shape, the implantable prosthesis according to claim 1.

13. The body is formed of an absorbent material, and the body is formed of P4HB (poly-4-hydroxybutyrate), the implantable prosthesis according to claim 1.

14. The body is tissue-permeable, the implantable prosthesis according to claim 1.

15. The body is formed of a mesh fabric, the mesh fabric is tissue-permeable, and the plurality of cavities are configured such that fat and / or tissue fills and passes through the body and enables the implantable prosthesis to expand, the implantable prosthesis according to claim 14.

16. The body is configured to increase and / or reconstruct the anatomical shape of the human breast, the implantable prosthesis according to claim 1.

17. An implantable prosthesis, a body having a three-dimensional form of a biocompatible material, a hollow core located along a core axis; a plurality of body segments circumferentially arranged around the hollow core, each of the plurality of body segments extending in a radially outward direction away from the core axis, each body segment including at least four body layers fabricated from a sheet of material, the sheet being folded around a first fold and a second fold transverse to the first fold, the plurality of body segments; a plurality of cavities formed by the plurality of body segments, the plurality of cavities facing in the radially outward direction away from the hollow core including a body including an implantable prosthesis.

18. Each of the body layers is joined together along the second fold line, and the second fold line extends in a direction parallel to the core axis, the implantable prosthesis according to claim 17.

19. The second fold line divides the first fold line into a first fold line segment and a second fold line segment, and the first and second fold line segments extend radially with respect to the core axis, the implantable prosthesis according to claim 17.

20. The first fold line segment joins together a first pair of the body layers, and the second fold line segment joins together a second pair of the body layers, the implantable prosthesis according to claim 19.

21. Each of the first and second pairs of the body layers includes an inner body layer and an outer body layer, the inner body layers of the first and second pairs of the body layers face each other, and are located between the outer body layers of the first and second pairs of the body layers, the implantable prosthesis according to claim 20.

22. Each body layer includes an outer peripheral edge portion extending from the proximal end portion to the distal end portion of the body segment, and the inner and outer body layers of each of the first and second pairs of the body layers are attached to each other at a first position adjacent to the outer peripheral edge portion between the proximal end portion and the distal end portion of the body segment, the implantable prosthesis according to claim 21.

23. The inner body layers of the body segment are attached to each other at a second position adjacent to the outer peripheral edge portion between the proximal end portion and the first position, the implantable prosthesis according to claim 22.

24. Each outer body layer of the body segment is attached to the outer body layer of an adjacent body segment at a second position adjacent to the outer peripheral edge portion between the proximal end portion and the first position, the implantable prosthesis according to claim 23.

25. Each outer body layer of the body segment is attached to the outer body layer of an adjacent body segment at a third position between the first position and the distal end portion of the body segment, the implantable prosthesis according to claim 23.

26. The first and second fold line segments are located at the proximal end portion of the body, the implantable prosthesis according to claim 22.

27. The implantable prosthesis according to claim 26, further comprising a proximal material layer attached to the proximal end portion of the main body in the first and second fold segments of each main body segment.

28. The implantable prosthesis according to claim 17, wherein the second fold is perpendicular to the first fold, and the main body has a frustum shape.

29. The implantable prosthesis according to claim 26, wherein the proximal end portion has a first diameter and the distal end portion has a second diameter smaller than the first diameter.

30. The implantable prosthesis according to claim 17, wherein the main body is formed of an absorbent material, the main body is formed of P4HB (poly-4-hydroxybutyrate), and the main body is tissue-permeable.

31. The implantable prosthesis according to claim 17, wherein the main body is formed of a mesh fabric, the mesh fabric is tissue-permeable, and the plurality of cavities are configured such that fat and / or tissue fills and passes through the main body and enables the implantable prosthesis to expand.

32. The implantable prosthesis according to claim 17, wherein the main body is configured to increase and / or reconstruct the anatomical shape of a human breast, and further includes a hollow core structure located along the core axis to form the hollow core, and the plurality of main body segments are connected to the hollow core structure.

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