Devices and methods of making and use thereof

Abstract

Disclosed herein are devices and methods of making and use thereof. Devices, kits, and methods for soft-tissue support are provided. In certain examples, an arc-shaped scaffold includes openings arranged to create directional, anisotropic expansion to conform to an anatomical contour while limiting undesired stretch. In some examples, a symmetrical configuration enables bilateral use, including with polarity-sensitive materials. In some examples, an anchoring system includes tabs configured to be folded posteriorly and fenestrations or openings proximate a folding edge that permit direct suturing to underlying tissue without parachute sutures. Methods of making and using the devices are also provided.

Description

[0001] DEVICES AND METHODS OF MAKING AND USE THEREOF CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U. S. Provisional Application No.

[0002] 63 / 728,413 filed December 5, 2024, which is hereby incorporated herein by reference in its entirety.

[0003] BACKGROUND

[0004] Reconstructive and cosmetic surgeries require advanced solutions for long-term structural support of soft tissues, particularly in areas prone to ptosis, such as the lower pole of the breast. Traditional solutions — such as meshes, ADM scaffolds, and bioresorbable materials — fall short in their adaptability, structural integrity, or ease of use during surgery. These limitations result in suboptinial outcomes, including sagging, migration, or inefficient implantation processes.

[0005] With current technologies and techniques needing improvement, new methods and devices are necessary. The devices and methods discussed herein address these and other needs.

[0006] SUMMARY

[0007] In accordance with the purposes of the disclosed devices and methods as embodied and broadly described herein, the disclosed subject matter relates to devices and methods of making and use thereof.

[0008] For example, disclosed herein are devices configured to be inserted into an anatomical location of a subject. In some examples, the devices comprise: a biocompatible material having an upper edge, a lower edge, a folding edge, and a thickness; one or more notches in the lower edge, such that the device further comprises a plurality of tabs along the lower edge; wherein the tabs are configured to be folded or tucked in along the folding edge after insertion at the anatomical location; and one or more slits, each of the slits perforating the thickness of the biocompatible material, wherein the slits are located proximate the folding edge, opposite the tabs, such that after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, and the slits allow for access to the tabs through the device.

[0009] In some examples, the device includes 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, or 10 or more notches. In some examples, the device includes 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 11 or more tabs.

[0010] In some examples, the device includes 3 notches and 4 tabs. In some examples, the notches and tabs are configured to provide dual functionality for orientation and anchoring.

[0011] In some examples, the number, location, size, and / or shape of the notches are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0012] In some examples, the notches are configured such that the tabs do not overlap when tucked in to conform to the 3D curvature / proj ection of the anatomical location.

[0013] In some examples, the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0014] In some examples, the tabs are configured such that they do not overlap when tucked in to conform to the 3D curvature / proj ection of the breast.

[0015] In some examples, the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ), for example to accommodate a sufficient number of sutures, anchors, staples, etc. to securely attach the device in the subject after insertion at the anatomical location.

[0016] In some examples, the device includes 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, 11 or more, 12 or more, 13 or more, 14 or more, or 15 or more slits.

[0017] In some examples, the slits are oriented along the folding edge.

[0018] In some examples, the number, location, size, and / or shape of the slits are selected in view of the size of the tabs.

[0019] In some examples, the slits allow freedom of access to the tabs after the tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

[0020] In some examples, each of the slits has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material.

[0021] In some examples, each of the tabs can further comprise one or more perforations that perforates the thickness of the biocompatible material. In some examples, the one or more perforations on the tabs is oriented such that they align with a slit after tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location. In some examples, after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, the slits allow for access to the tabs through the device, and the perforations allow for access to the subject through the tabs for anchoring the device to the subject.

[0022] In some examples, at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape.

[0023] In some examples, the device further comprises a plurality of fenestrations, each of the plurality of fenestrations perforating the thickness of the biocompatible material: wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject.

[0024] In some examples, the device provides enhanced support at the anatomical location. In some examples, the device comprises: a biocompatible material having an upper edge, a lower edge, and a thickness, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape; and a plurality of fenestrations, each of the plurality of fenestrations perforating the thickness of the biocompatible material; wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject; wherein the device provides enhanced support at the anatomical location.

[0025] In some examples, the number, location, size, and / or shape of the fenestrations are selected in view the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0026] In some examples, the fenestrations are arranged radially.

[0027] In some examples, the device comprises: a biocompatible material having an upper edge, a lower edge, and a thickness, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape; and a plurality of radial fenestrations, each of the plurality of radial fenestrations perforating the thickness of the biocompatible material; wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject; wherein the device provides enhanced support at the anatomical location.

[0028] In some examples, the number, location, size, and / or shape of the radial fenestrations are selected in view the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0029] In some examples, at least a portion of the plurality of the fenestrations (e.g., the plurality of radial fenestrations) are located towards the upper edge of the device where the most expansion is desired. In some examples, the fenestrations (e.g., the radial fenestrations) are staggered to allow maximum opening without weakening the device.

[0030] In some examples, each of the fenestrations (e.g., each of the radial fenestrations) has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material.

[0031] In some examples, the device further comprises one or more notches (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, or 10 or more) in the lower edge, such that the device further comprises a plurality of tabs (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 11 or more) along the lower edge. In some examples, the device includes 3 notches and 4 tabs.

[0032] In some examples, the notches and tabs are configured to provide dual functionality for orientation and anchoring.

[0033] In some examples, the number, location, size, and / or shape of the notches are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0034] In some examples, the notches are configured such that the tabs do not overlap when tucked in to conform to the 3D curvature / proj ection of the anatomical location.

[0035] In some examples, the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0036] In some examples, the tabs are configured such that they do not overlap when tucked in to conform to the 3D curvature / proj ection of the breast.

[0037] In some examples, the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ), for example to accommodate a sufficient number of sutures, anchors, staples, etc. to securely attach the device in the subject after insertion at the anatomical location.

[0038] In some examples, the device further comprises a folding edge, wherein the tabs can be folded or tucked in along the folding edge after insertion at the anatomical location.

[0039] In some examples, the device further comprises one or more slits (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, 11 or more, 12 or more, 13 or more, 14 or more, or 15 or more), each of the slits perforating the thickness of the biocompatible material.

[0040] In some examples, slits are located proximate the folding edge, opposite the tabs.

[0041] In some examples, the slits are oriented along the folding edge. In some examples, the number, location, size, and / or shape of the slits can be selected in view of the size of the tabs.

[0042] In some examples, the slits allow freedom of access to the tabs after the tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

[0043] In some examples, after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, and the slits allow for access to the tabs through the device.

[0044] In some examples, each of the slits has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material.

[0045] In some examples, each of the tabs can further comprise one or more perforations that perforates the thickness of the biocompatible material, and wherein the one or more perforations on the tabs is oriented such that they align with a slit after tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

[0046] In some examples, after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, the slits allow for access to the tabs through the device, and the perforations allow for access to the subject through the tabs for anchoring the device to the subject.

[0047] In some examples, the device is symmetrical.

[0048] In some examples, the device is configured to be elastic along a direction (e.g., horizontally), but have minimal elasticity perpendicular to said direction (e.g., vertically).

[0049] In some examples, the biocompatible material comprises ADM, a bioresorbable polymer, a composite material, a synthetic material, or a combination thereof.

[0050] In some examples, the biocompatible material comprises a polymer such as a bioresorbable polymer, collagen, or a combination thereof.

[0051] In some examples, the biocompatible material comprises a synthetic material, such as a synthetic mesh.

[0052] In some examples, the biocompatible material comprises a shape-memory material. In some examples, the biocompatible material comprises a biological matrix. In some examples, the biological matrix is derived from human dermis, animal dermis, or animal material. In some examples, the biological matrix comprises FlexHD pliable ADM, FlexHD pliable MAX ADM, AlloDerm®, DermACELL (e.g., DermACELL AWM®, etc.), porcine ADM, STRATTICE®, CORTIVA™ (e.g., CORTIVA™ allograft dermis), ALLOMAX™, SurgiMend®, ARTIA™, XenMatrix™, Permacol™, Tutopatch™, or a combination thereof. In some examples, the biocompatible material comprises vicryl mesh, gortex, poly(4-Hydroxybuterate) (e.g., Galaflex), Polydioxanone (PDO) (e.g., Durasorb), polyglycolic acid trimethylene carbonate (PGA- PMC) (e.g., TIGR matrix), silk (e.g., SERI scaffold), polypropylene and / or polyglycolic acid (e.g., OviTex®), ULTRAPRO™ mesh, PROCEED™ mesh, Phasix™ mesh, or a combination thereof.

[0053] In some examples, the device is reversible (e.g., posterior and anterior surfaces are substantially the same).

[0054] In some examples, the device has a posterior surface and an anterior surface, the posterior surface and the anterior surface being different.

[0055] In some examples, the device is configured to support and / or reshape at least a portion of an organ and / or at least a portion of an implant when inserted into the anatomical location of the subject.

[0056] In some examples, the device has a two dimensional shape that can stretch to a three dimensional shape that conforms to support and / or reshape an organ and / or an implant when inserted into the anatomical location of the subject.

[0057] In some examples, the anatomical location comprises a breast, a buttock, abdominal wall, or pelvic floor of the subject.

[0058] In some examples, the anatomical location comprises a breast of the subject.

[0059] In some examples, the device is configured to support at least a portion of a breast or at least a portion of a breast implant.

[0060] In some examples, the device is for facilitating reconstruction, augmentation, and / or cosmetic improvement of a breast, the breast having an upper pole, a lower pole, a most projecting portion, and an inframammary fold, wherein the device is configured to support and / or reshape at least a portion of the lower pole.

[0061] In some examples, the device is configured to be positioned such that the upper edge is positioned towards the most projecting portion and extending inferiorly to the lower edge positioned towards the inframammary fold.

[0062] In some examples, the device is configured to be utilized with a breast implant.

[0063] In some examples, the device is configured to cover a portion of the breast implant. In some examples, in use, the device is positioned prepectorally or postpectorally, anterior to the breast implant.

[0064] In some examples, the size and / or shape of the device is selected based on the volume and / or shape of the breast implant. In some examples, the breast implant has an intra-operative fill volume of from 0 cubic centimeters (cc) to 1500 cc.

[0065] In some examples, the device is a single piece (e.g., monolithic).

[0066] In some examples, the device is biocompatible.

[0067] In some examples, the device further comprises a therapeutic agent dispersed within at least a portion of the device.

[0068] In some examples, the therapeutic agent is dispersed substantially homogeneously throughout the device.

[0069] In some examples, the therapeutic agent comprises an anticancer agent, antiinflammatory agent, analgesic agent, antimicrobial agent, a growth factor, an anti-fibrotic agent, or a combination thereof.

[0070] In some examples, the therapeutic agent comprises a chemotherapeutic agent, an immunotherapeutic agent, or a combination thereof.

[0071] In some examples, the device is configured to be stable for an amount of time after the device is implanted in the subject.

[0072] In some examples, the device is configured to biodegrade over an amount of time after the device is implanted in the subject.

[0073] In some examples, the device is anatomically designed for the subject.

[0074] In some examples, the device is implantable in the subject.

[0075] In some examples, the device is configured to conforms to anatomical contours, ensuring uniform tension distribution and long-term ptosis prevention.

[0076] In some examples, the plurality of fenestrations are configured to balance adaptability with material integrity, focusing on areas requiring maximum projection.

[0077] In some examples, the device comprises the device of any one of Figure 1 - Figure 31. Also disclosed herein are kits comprising any of the devices disclosed herein disposed within a sterile package. In some examples, the kit further comprises a pre-marking template, a stapling device, or a combination thereof.

[0078] Also disclosed herein are methods of making any of the devices disclosed herein. In some examples, the method comprises: introducing the plurality of fenestrations in the biocompatible material; forming the upper and / or lower edge of the device; forming the notches and / or tabs; forming the slits; or a combination thereof.

[0079] In some examples, the method comprises making the device based on an anatomical image of a subject. In some examples, the method further comprises collecting the anatomical image of the subject. In some examples, the method further comprises anatomically designing the device for the subject.

[0080] Also disclosed herein are methods of use of any of the devices disclosed herein. In some examples, the method is a method of treating a subject in need thereof, the method comprising implanting any of the devices disclosed herein into the subject.

[0081] In some examples, the device is implanted into at least a portion of a breast of the subject.

[0082] In some examples, the method comprises breast reconstruction, augmentation (e.g., full or partial breast reconstruction or augmentation), and / or cosmetic improvement such as after a lumpectomy or mastectomy.

[0083] In some examples, the method comprises one stage or two stage implant based breast reconstruction.

[0084] In some examples, the method further comprises anatomically designing the device for the subject.

[0085] In some examples, the device is secured after implantation, for example using sutures, staples, etc.

[0086] Additional advantages of the disclosed devices and methods will be set forth in part in the description which follows, and in part will be obvious from the description. The advantages of the disclosed devices and methods will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosed systems and methods, as claimed.

[0087] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

[0088] BRIEF DESCRIPTION OF THE FIGURES

[0089] The accompanying figures, which are incorporated in and constitute a part of this specification, illustrate several aspects of the disclosure, and together with the description, serve to explain the principles of the disclosure.

[0090] Figure 1. Schematic illustration of an example device according to one implementation. Figure 2. Schematic illustration of an example device according to one implementation. Figure 3. Schematic illustration of an example device according to one implementation. Figure 4. Schematic illustration of a breast. Figure 5. Schematic illustration of an example device after insertion according to one implementation.

[0091] Figure 6. Schematic illustration of an example device after insertion according to one implementation.

[0092] Figure 7. Schematic illustration of an example device according to one implementation. Figure 8. Schematic illustration of an example device according to one implementation. Figure 9. Schematic illustration of an example device according to one implementation. Figure 10. Schematic illustration of an example device according to one implementation. Figure 11. Schematic illustration of an example device according to one implementation. Figure 12. Schematic illustration of an example device according to one implementation. Figure 13. Schematic illustration of an example device according to one implementation. Figure 14. Schematic illustration of an example device after insertion according to one implementation.

[0093] Figure 15. Schematic illustration of an example device after insertion according to one implementation.

[0094] Figure 16. Schematic illustration of an example device according to one implementation. Figure 17. Schematic illustration of an example device after the tabs have been folded under the device along the folding edge according to one implementation.

[0095] Figure 18. Schematic illustration of an example device according to one implementation. Figure 19. Schematic illustration of an example device according to one implementation. Figure 20. Schematic illustration of an example device according to one implementation. Figure 21. Schematic illustration of an example device according to one implementation. Figure 22. Schematic illustration of an example device according to one implementation. Figure 23. Schematic illustration of an example device after insertion according to one implementation.

[0096] Figure 24. Schematic illustration of an example device after insertion according to one implementation.

[0097] Figure 25. Schematic illustration of an example device after insertion according to one implementation.

[0098] Figure 26. Schematic illustration of an example device after insertion according to one implementation.

[0099] Figure 27. Schematic illustration of an example device after insertion according to one implementation.

[0100] Figure 28. Schematic illustration of an example device according to one implementation. Figure 29. Schematic illustration of an example device according to one implementation. Figure 30. Schematic illustration of an example device according to one implementation, with a close up on the slit-tab-suture relationship.

[0101] Figure 31. Schematic illustration of an example device according to one implementation, showing reinforced slit edge detail, for example for synthetic mesh materials.

[0102] DETAILED DESCRIPTION

[0103] The devices and methods described herein may be understood more readily by reference to the following detailed description of specific aspects of the disclosed subject matter and the Examples included therein.

[0104] Before the present devices and methods are disclosed and described, it is to be understood that the aspects described below are not limited to specific synthetic methods or specific reagents, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

[0105] Also, throughout this specification, various publications are referenced. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which the disclosed matter pertains. The references disclosed are also individually and specifically incorporated by reference herein for the material contained in them that is discussed in the sentence in which the reference is relied upon.

[0106] General Definitions

[0107] In this specification and in the claims that follow, reference will be made to a number of terms, which shall be defined to have the following meanings.

[0108] Throughout the description and claims of this specification, the word “comprise” and other forms of the word, such as “comprising” and “comprises,” means including but not limited to, and is not intended to exclude, for example, other additives, components, integers, or steps.

[0109] As used in the description and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a composition” includes mixtures of two or more such compositions, reference to “an agent” includes mixtures of two or more such agents, reference to “the component” includes mixtures of two or more such components, and the like.

[0110] “Optional” or “optionally” means that the subsequently described event or circumstance can or cannot occur, and that the description includes instances where the event or circumstance occurs and instances where it does not. Ranges can be expressed herein as from “about” one particular value, and / or to “about” another particular value. By “about” is meant within 5% of the value, e.g., within 4, 3, 2, or 1 % of the value. When such a range is expressed, another aspect includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0111] Values can be expressed herein as an “average” value. “Average” generally refers to the statistical mean value.

[0112] By “substantially” is meant within 5%, e.g., within 4%, 3%, 2%, or 1%.

[0113] “Exemplary” means “an example of” and is not intended to convey an indication of a preferred or ideal embodiment. “Such as” is not used in a restrictive sense, but for explanatory purposes.

[0114] It is understood that throughout this specification the identifiers “first” and “second” are used solely to aid in distinguishing the various components and steps of the di sclosed subject matter. The identifiers “first” and “second” are not intended to imply any particular order, amount, preference, or importance to the components or steps modified by these terms.

[0115] References in the specification and concluding claims to parts by weight of a particular element or component in a composition denotes the weight relationship between the element or component and any other elements or components in the composition or article for which a part by weight is expressed. Thus, in a compound containing 2 parts by weight of component X and 5 parts by weight component Y, X and Y are present at a weight ratio of 2:5, and are present in such ratio regardless of whether additional components are contained in the compound.

[0116] A weight percent (wt. %) of a component, unless specifically stated to the contrary, is based on the total weight of the formulation or composition in which the component is included.

[0117] The term “or combinations thereof’ as used herein refers to all permutations and combinations of the listed items preceding the term. For example, “A, B, C, or combinations thereof” is intended to include at least one of: A, B, C, AB, AC, BC, or ABC, and if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB.

[0118] Continuing with this example, expressly included are combinations that contain repeats of one or more item or term, such as BB, AAA, AB, BBC, AAABCCCC, CBBAAA, CAB ABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context. As used herein, by a “subject” is meant an individual. Thus, the “subject” can include domesticated animals (e.g., cats, dogs, etc.), livestock (e.g., cattle, horses, pigs, sheep, goats, etc.), laboratory animals (e.g., mouse, rabbit, rat, guinea pig, etc.), and birds. “Subject” can also include a mammal, such as a primate or a human. Thus, the subject can be a human or veterinary patient. The term “patient” refers to a subject under the treatment of a clinician, e.g., physician.

[0119] “Biocompatible” and “biologically compatible”, as used herein, generally refer to compounds and / or compositions that are, along with any metabolites or degradation products thereof, generally non-toxic to normal cells and tissues, and which do not cause any significant adverse effects to normal cells and tissues when cells and tissues are incubated (e.g., cultured) in their presence.

[0120] The term “biodegradable” or “bioresorbable” as used herein refers to a material or substance wherein physical dissolution and / or chemical degradation is effected under physiological conditions.

[0121] As used herein, “antimicrobial” refers to the ability to treat or control (e.g., reduce, prevent, treat, or eliminate) the growth of a microbe at any concentration. Similarly, the terms “antibacterial,” “antifungal,” and “antiviral” refer to the ability to treat or control the growth of bacteria, fungi, and viruses at any concentration, respectively.

[0122] As used herein, “reduce” or other forms of the word, such as “reducing” or “reduction,” refers to lowering of an event or characteristic (e.g., microbe population / infection). It is understood that the reduction is typically in relation to some standard or expected value. For example, “reducing microbial infection” means reducing the spread of a microbial infection relative to a standard or a control.

[0123] As used herein, “prevent” or other forms of the word, such as “preventing” or “prevention,” refers to stopping a particular event or characteristic, stabilizing or delaying the development or progression of a particular event or characteristic, or minimizing the chances that a particular event or characteristic will occur. “Prevent” does not require comparison to a control as it is typically more absolute than, for example, “reduce.” As used herein, something could be reduced but not prevented, but something that is reduced could also be prevented. Likewise, something could be prevented but not reduced, but something that is prevented could also be reduced.

[0124] As used herein, “heat” or other forms of the word, such as “heated” or “treatment,” refers to administration of a composition or performing a method in order to reduce, prevent, inhibit, or eliminate a particular characteristic or event (e.g., microbe growth or survival). The term “control” is used synonymously with the term “treat.” The term “anticancer” refers to the ability to treat or control cellular proliferation and / or tumor growth at any concentration.

[0125] The term “therapeutically effective” refers to the amount of the composition used is of sufficient quantity to ameliorate one or more causes or symptoms of a disease or disorder. Such amelioration only requires a reduction or alteration, not necessarily elimination.

[0126] The term “pharmaceutically acceptable” refers to those compounds, materials, compositions, and / or dosage forms which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problems or complications commensurate with a reasonable benefit / risk ratio.

[0127] As used herein, “molecular weight” refers to the number average molecular weight as measured by1H NMR spectroscopy, unless indicated otherwise.

[0128] Devices and Methods of Making and Use Thereof

[0129] Disclosed herein are devices configured to be inserted into an anatomical location of a subject.

[0130] Devices, kits, and methods for soft-tissue support are provided. In certain examples, an arc-shaped scaffold includes openings arranged to create directional, anisotropic expansion to conform to an anatomical contour while limiting undesired stretch. In some examples, a symmetrical configuration enables bilateral use, including with polarity-sensitive materials. In some examples, an anchoring system includes tabs configured to be folded posteriorly and fenestrations or openings proximate a folding edge that permit direct suturing to underlying tissue without parachute sutures. Methods of making and using the devices are also provided.

[0131] In some examples, the devices can comprise a biocompatible material having an upper edge, a lower edge, a folding edge, and a thickness; one or more notches (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, or 10 or more) in the lower edge, such that the device further comprises a plurality of tabs (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 11 or more) along the lower edge, wherein the tabs are configured to be folded or tucked in along the folding edge after insertion at the anatomical location; and one or more slits (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, 11 or more, 12 or more, 13 or more, 14 or more, or 15 or more), each of the slits perforating the thickness of the biocompatible material, wherein the slits are located proximate the folding edge, opposite the tabs, such that after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, and the slits allow for access to the tabs through the device. In some examples, at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape.

[0132] In some examples, the devices comprise: a sheet of biocompatible material having an upper edge, a lower edge, and a folding edge; a plurality of tabs along the lower edge configured to be folded posteriorly along the folding edge; and a row of slits or openings located proximate the folding edge and opposite the tabs, the slits or openings being positioned such that, with the tabs folded posteriorly, a suture can be passed from an anterior surface of the device through a slit or opening and through a folded tab to secure the device to underlying tissue, thereby anchoring the device without parachute sutures.

[0133] In some examples, the devices comprise an arc-shaped sheet of biocompatible material and a plurality of openings arranged and oriented to permit expansion in a first direction and to limit expansion in a second, different direction, thereby allowing the device to conform to an anatomical contour while resisting vertical stretch.

[0134] In some examples, the devices can comprise: a biocompatible material having an upper edge, a lower edge, and a thickness, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape; and a plurality of fenestrations, each of the plurality of fenestrations perforating the thickness of the biocompatible material. In some examples, the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject. In some examples, the device provides enhanced support at the anatomical location. In some examples, wherein the number, location, size, and / or shape of the fenestrations are selected in view the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control. In some examples, the fenestrations are arranged radially.

[0135] In some examples, the devices can comprise: a biocompatible material having an upper edge, a lower edge, and a thickness, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape; and a plurality of radial fenestrations, each of the plurality of radial fenestrations perforating the thickness of the biocompatible material. In some examples, the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject. In some examples, the device provides enhanced support at the anatomical location. In some examples, at least a portion of the plurality of radial fenestrations are located towards the upper edge of the device where most expansion is desired. In some examples, the radial fenestrations are staggered to allow maximum opening without weakening the device. Fenestrations

[0136] As used herein, the term “fenestrations” include any openings (e.g., slits, slots, holes of circular / elliptical / polygonal / irregulai’ shape / etc.) and can be arranged radially or non-radially (e.g., tangential rows) to engineer anisotropic expansion.

[0137] In some examples, the device further comprises a plurality of fenestrations, each of the plurality of fenestrations perforating the thickness of the biocompatible material: wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject. In some examples, the device provides enhanced support at the anatomical location.

[0138] In some examples, the fenestrations can be arranged in any suitable pattern or orientation desired for the specific application (e.g., radially, linearly, etc.). In some examples, the number, location, size, orientation, and / or shape of the fenestrations are selected in view of the biocompatible material. For example, the fenestrations can be linear and can be oriented perpendicular to the fiber direction of maximum elasticity of a synthetic mesh. In some examples, the fenestrations can be in a non-radial pattern adapted to mesh weave geometry.

[0139] In some examples, the fenestrations (e.g., openings) are non-radial, for example tangential segments arranged in one or more concentric rows between the upper edge and a fold line. Such non-radial arrangements can, for example, be advantageous for woven or knitted synthetic meshes whose fiber orientation presents directional elasticity; orienting fenestrations (e.g., openings) perpendicular to the dominant fiber direction can permit lateral expansion while limiting vertical stretch to resist ptosis.

[0140] In some examples, the fenestrations can be arranged radially (e.g., the device comprises a plurality of radial fenestrations).

[0141] In some examples, at least a portion of the plurality of the fenestrations (e.g., the plurality of radial fenestrations) are located towards the upper edge of the device where the most expansion is desired.

[0142] In some examples, the fenestrations (e.g., the radial fenestrations) are staggered to allow maximum opening without weakening the device.

[0143] In some examples, the number, location, size, and / or shape of the fenestrations are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0144] For example, the fenestrations can have any suitable shape, such as a linear slit and / or a hole or cutout with any suitable shape desired for the specific application (e.g., a circle, an ellipse, a quadrilateral, a triangle, a polygon, an irregular shape, etc.). In some examples, each of the fenestrations (e.g., each of the radial fenestrations) has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material, for example as shown in Figure 31. The reinforcing or sealing can, for example, comprise heat-sealing, ultrasonic welding, adhesive bonding (e.g., with a biocompatible adhesive), hemming, edge coating, or a combination thereof.

[0145] Notches, Tabs, and Slits

[0146] In some examples, the device further comprises one or more notches (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, or 10 or more) in the lower edge, such that the device further comprises a plurality of tabs (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 11 or more) along the lower edge. In some examples, the device includes 3 notches and 4 tabs.

[0147] In some examples, the notches and tabs are configured to provide dual functionality for orientation and anchoring.

[0148] In some examples, the number, location, size, and / or shape of the notches are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0149] In some examples, the notches are configured such that the tabs do not overlap when tucked in to conform to the 3D curvature / proj ection of the anatomical location.

[0150] In some examples, the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control. In some examples, the tabs are configured such that they do not overlap when tucked in to conform to the 3D curvature / proj ection of the breast.

[0151] In some examples, the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ), for example to accommodate a sufficient number of sutures, anchors, staples, etc. to securely attach the device in the subject after insertion at the anatomical location.

[0152] In some examples, the device further comprises a folding edge, wherein the tabs can be folded or tucked in along the folding edge after insertion at the anatomical location.

[0153] In some examples, the device further comprises one or more slits (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, 11 or more, 12 or more, 13 or more, 14 or more, or 15 or more), each of the slits perforating the thickness of the biocompatible material. The slits can, for example, be located proximate the folding edge, opposite the tabs. The slits can, for example, be oriented along the folding edge. In some examples, the number, location, size, and / or shape of the slits can be selected in view of the size of the tabs.

[0154] For example, the slits can have any suitable shape, such as a linear slit and / or a hole or cutout with any suitable shape desired for the specific application (e.g., a circle, an ellipse, a quadrilateral, a triangle, a polygon, an irregular shape, etc.). In some examples, the slits can comprise a linear slit terminated at each end with a hole or cutout, such as a circle.

[0155] For example, the slits can allow freedom of access to the tabs after the tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location. For example, after tucking in or folding back the tabs, the tabs can be located posterior to the rest of the device, and the slits can allow for access to the tabs through the device, as shown for example in Figure 3, Figure 17, Figure 23, Figure 24, and Figure 30.

[0156] In some examples, each of the slits has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material, for example as shown in Figure 31. The reinforcing or sealing can, for example, comprise heat-sealing, ultrasonic welding, adhesive bonding (e.g., with a biocompatible adhesive), hemming, edge coating, or a combination thereof.

[0157] In some examples, each of the tabs can further comprise one or more perforations that perforates the thickness of the biocompatible material. In some examples, the one or more perforations on the tabs can be oriented such that they align with a slit after tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location. For example, after tucking in or folding back the tabs, the tabs can be located posterior to the rest of the device, the slits can allow for access to the tabs through the device, and the perforations can allow for access to the subject through the tabs for anchoring the device to the subject, as shown for example in Figure 28 - Figure 30.

[0158] In some examples, each tab can further include one or more perforations. In some examples, the perforations align with a slit or opening when the tab is folded posteriorly, facilitating passage of a suture or staple through the device and the tab into the chest wall.

[0159] In some examples, when the tabs are folded posteriorly, the slits / openings proximate the folding edge are positioned so that a needle passes from the anterior surface, through a slit / opening, through the folded tab, and into the chest wall, enabling direct fixation without parachute sutures and improving reproducibility in small pockets or robot-assisted approaches.

[0160] Devices

[0161] In some examples, the device is symmetrical.

[0162] In some examples, the device is symmetrical about a midline and configured for use with a polarity-sensitive material such that the device can be implanted on either the left or right side without separate mirrored versions, maintaining consistent integration characteristics.

[0163] In some examples, the device is configured to be elastic along a direction (e.g., horizontally), but have minimal elasticity perpendicular to said direction (e.g., vertically).

[0164] In some examples, the biocompatible material comprises ADM, a bioresorbable polymer, a composite material, a synthetic material, or a combination thereof.

[0165] In some examples, the biocompatible material comprises a polymer such as a bioresorbable polymer, collagen, or a combination thereof.

[0166] In some examples, the biocompatible material comprises a synthetic material, such as a synthetic mesh.

[0167] In some examples, the biocompatible material comprises a shape-memory material. In some examples, the biocompatible material comprises a biological matrix. In some examples, the biological matrix is derived from human dermis, animal dermis, or animal material. In some examples, the biological matrix comprises FlexHD pliable ADM, FlexHD pliable MAX ADM, AlloDerm®, DermACELL (e.g., DermACELL AWM®, etc.), porcine ADM, STRATTICE®, CORTIVA™ (e.g., CORTIVA™ allograft dermis), ALLOMAX™, SurgiMend®, ARTIA™, XenMatrix™, Pemiacol™, Tutopatch™, or a combination thereof.

[0168] In some examples, the biocompatible material comprises vicryl mesh, gortex, poly(4- Hydroxybuterate) (e.g., Galaflex), Polydioxanone (PDO) (e.g., Durasorb), polyglycolic acid trimethylene carbonate (PGA- PMC) (e.g., TIGR matrix), silk (e.g., SERI scaffold), polypropylene and / or polyglycolic acid (e.g., OviTex®), ULTRAPRO™ mesh, PROCEED™ mesh, Phasix™ mesh, or a combination thereof.

[0169] In some examples, the device is reversible (e.g., posterior and anterior surfaces are substantially the same).

[0170] In some examples, the device has a posterior surface and an anterior surface, the posterior surface and the anterior surface being different.

[0171] In some examples, the device is configured to support and / or reshape at least a portion of an organ and / or at least a portion of an implant when inserted into the anatomical location of the subject.

[0172] In some examples, the device has a two dimensional shape that can stretch to a three dimensional shape that conforms to support and / or reshape an organ and / or an implant when inserted into the anatomical location of the subject.

[0173] In some examples, the anatomical location comprises a breast, a buttock, abdominal wall, or pelvic floor of the subject. In some examples, the anatomical location comprises a breast of the subject.

[0174] In some examples, the device is configured to support at least a portion of a breast or at least a portion of a breast implant.

[0175] In some examples, the device is for facilitating reconstruction, augmentation, and / or cosmetic improvement of a breast, the breast having an upper pole, a lower pole, a most projecting portion, and an inframammary fold, wherein the device is configured to support and / or reshape at least a portion of the lower pole. In some examples, the device is configured to be positioned such that the upper edge is positioned towards the most projecting portion and extending inferiorly to the lower edge positioned towards the inframammary fold.

[0176] In some examples, the device is configured to be utilized with a breast implant. In some examples, the device is configured to cover a portion of the breast implant. In some examples, in use, the device is positioned prepectorally or postpectorally, anterior to the breast implant. In some examples, the size and / or shape of the device is selected based on the volume and / or shape of the breast implant. In some examples, the breast implant has an intra-operative fill volume of from 0 cubic centimeters (cc) to 1500 cc.

[0177] In some examples, the device is a single piece (e.g., monolithic).

[0178] In some examples, the device is biocompatible.

[0179] In some examples, the device further comprises a therapeutic agent dispersed within at least a portion of the device. In some examples, the therapeutic agent is dispersed substantially homogeneously throughout the device. In some examples, the therapeutic agent is dispersed inhomogeneously throughout the device (e.g., randomly, along a concentration gradient, only in certain portions, etc.).

[0180] The therapeutic agent can, for example, comprise an anticancer agent, anti-inflammatory agent, analgesic agent, antimicrobial agent, a growth factor, an anti-fibrotic agent, or a combination thereof. As used herein, antimicrobials include, for example, antibacterials, antifungals, and antivirals.

[0181] Examples of antimicrobial agents include, but are not limited to, alexidine, asphodelin A, atromentin, auranthine, austrocortilutein, austrocortirubin, azerizin, chlorbisan, chloroxine, cidex, cinoxacin, citreorosein, copper usnate, cupiennin, curvularin, DBNPA, dehydrocurvularin, desoxyfructo-serotonin, dichloroisocyanuric acid, elaiomycin, holtfreter's solution, malettinin, naphthomycin, neutrolin, niphimycin, nitrocefin, oxadiazoles, paenibacterin, proclin, ritiometan, ritipenem, silicone quaternary amine, stylisin, taurolidine, tirandamycin, trichloroisocyanuric acid, triclocarban, and combinations thereof. Examples of antibacterials include, but are not limited to, acetoxycycloheximide, aciduliprofundum, actaplanin, actinorhodin, alazopeptin, albomycin, allicin, allistatin, allyl isothiocyanate, ambazone, aminocoumarin, aminoglycosides, 4-aminosalicylic acid, ampicillin, ansamycin, anthramycin, antimycin A, aphidicolin, aplasmomycin, archaeocin, arenicin, arsphenamine, arylomycin A2, ascofuranone, aspergillic acid, avenanthramide, avibactam, azelaic acid, bafilomycin, bambermycin, beauvericin, benzoyl peroxide, blasticidin S, bottromycin, brilacidin, caprazamycin, carbomycin, cathelicidin, cephalosporins, ceragenin, chartreusin, chromomycin A3, citromycin, clindamycin, clofazimine, dofoctol, clorobiocin, coprinol, coumermycin Al, cyclic lipopeptides, cycloheximide, cycloserine, dalfopristin, dapsone, daptomycin, debromomarinone, 17-dimethylaminoethylamino-17-demethoxygeldanamycin, echinomycin, endiandric acid C, enediyne, enviomycin, eravacycline, erythromycin, esperamicin, etamycin, ethambutol, ethionamide, (6S)-6-fluoroshikimic acid, fosfomycin, fosmidomycin, friulimicin, furazolidone, furonazide, fusidic acid, geldanamycin, gentamycin, gepotidacin, glycylcyclines, glycyrrhizol, gramicidin S, guanacastepene A, hachimycin, halocyamine, hedamycin, helquinoline, herbimycin, hexamethylenetetramine, hitachimycin, hydramacin-1, isoniazid, kanamycin, katanosin, kedarcidin, kendomycin, kettapeptin, kidamycin, lactivicin, lactocillin, landomycin, landomycinone, lasalocid, lenapenem, leptomycin, lincosamides, linopristin, lipiarmycins, macbecin, macrolides, macromomycin B, maduropeptin, mannopeptimycin glycopeptide, marinone, meclocycline, melafix,

[0182] methyl enomycin A, methylenomycin B, monensin, moromycin, mupirocin, mycosubtilin, myriocin, myxopyronin, naphthomycin A, narasin, neocarzinostatin, neopluramycin, neosalvarsan, neothramycin, netropsin, nifuroxazide, nifurquinazol, nigericin, nitrofural, nitrofurantoin, nocathiacin I, novobiocin, omadacycline, oxacephem, oxazolidinones, penicillins, peptaibol, phytoalexin, plantazolicin, platensimycin, plectasin, pluramycin A, polymixins, polyoxins, pristinamycin, pristinamycin IA, promin, prothionamide, pulvinone, puromycin, pyocyanase, pyocyanin, pyrenocine, questiomycin A, quinolones, quinupristin, ramoplanin, raphanin, resistome, reuterin, rifalazil, rifamycins, ristocetin, roseophllin, salinomycin, salinosporamide A, saptomycin, saquayamycin, seraticin, sideromycin, sodium sulfacetamide, solasulfone, solithromycin, sparassol, spectinomycin, staurosporine, streptazolin, streptogramin, streptogramin B, streptolydigin, streptonigrin, styelin A, sulfonamides, surfactin, surotomycin, tachyplesin, taktsa, tanespimycin, telavancin, tetracyclines, thioacetazone, thiocarlide, thiolutin, thiostrepton, tobramycin, trichostatin A, triclosan, trimethoprim, trimethoprim, tunicamycin, tyrocidine, urauchimycin, validamycin, viridicatumtoxin B, vulgamycin, xanthomycin A, xibornol, amikacin, amoxicillin, ampicillin, atovaquone, azithromycin, aztreonam, bacitracin, carbenicillin, cefadroxil, cefazolin, cefdinir, cefditoren, cefepime, cefiderocol, cefoperazone, cefotetan, cefoxitin, cefotaxime, cefpodoxime, cefprozil, ceftaroline, ceftazidime, ceftibuten, ceftizoxime, ceftriaxone, chloramphenicol, colistimethate, cefuroxime, cephalexin, cephradine, cilastatin, cinoxacin, ciprofloxacin, clarithromycin, clindamycin, dalbavancin, dalfopristin, daptomycin, demeclocycline, dicloxacillin, doripenem, doxycycline, eravacycline, ertapenem, erythromycin, fidaxomicin, fosfomycin, gatifloxacin, gemifloxacin, gentamicin, imipenem, lefamulin, lincomycin, linezolid, lomefloxacin, loracarbef, meropenem, metronidazole, minocycline, moxifloxacin, nafcillin, nalidixic acid, neomycin, norfloxacin, ofloxacin, omadacycline, oritavancin, oxacillin, oxytetracycline, paromomycin, penicillin, pentamidine, piperacillin, plazomicin, quinupristin, rifaximin, sarecycline, secnidazole, sparfloxacin, spectinomycin, sulfamethoxazole, sulfisoxazole, tedizolid, telavancin, telithromycin, ticarcillin, tigecycline, tobramycin, trimethoprim, trovafloxacin, vancomycin, and combinations thereof.

[0183] Examples of antifungals include, but are not limited to, abafungin, acibenzolar, acibenzolar-S-methyl, acrisorcin, allicin, aminocandin, amorolfine, amphotericin B, anidulafungin, azoxystrobin, bacillomycin, bacillus pumilus, barium borate, benomyl, binapacryl, boric acid, bromine monochloride, bromochlorosalicylanilide, bupirimate, butenafine, candicidin, caprylic acid, captafol, captan, carbendazim, caspofungin, cerulenin, chloranil, chlormidazole, chlorophetanol, chlorothalonil, chloroxylenol, chromated copper arsenate, ciclopirox, cilofungin, cinnamaldehyde, clioquinol, copper(I) cyanide, copper(II) arsenate, cruentaren, cycloheximide, davicil, dehydroacetic acid, dicarboximide fungicides, dichlofluanid, dimazole, diphenylamine, echinocandin, echinocandin B, epoxiconazole, ethonam, falcarindiol, falcarinol, famoxadone, fenamidone, fenarimol, fenpropi morph, fentin acetate, fenticlor, filipin, fluazinam, fluopicolide, flusilazole, fluxapyroxad, fuberidazole, griseofulvin, halicylindramide, haloprogin, hamycin, hexachlorobenzene, hexachlorocyclohexa-2,5-dien-l-one, 5-hydroxy-2(5H)-furanone, iprodione, lime sulfur, mancozeb, maneb, melafix, metalaxyl, metam sodium, methylisothiazolone, methylparaben, micafungin, miltefosine, monosodium methyl arsenate, mycobacillin, myclobutanil, natamycin, beta-nitrostyrene, nystatin, paclobutrazol, papulacandin B, parietin, pecilocin, pencycuron, pentamidine, pentachloronitrobenzene, pentachlorophenol, perimycin, 2-phenylphenol, polyene antimycotic, propamocarb, propiconazole, pterulone, ptilomycalin A, pyrazophos, pyrimethanil, pyrrolnitrin, selenium disulfide, sparassol, strobilurin, sulbentine, tavaborole, tebuconazole, terbinafine, theonellamide F, thymol, tiabendazole, ticlatone, tolciclate, tolnaftate, triadimefon, triamiphos, tribromometacresol, 2,4,6-tribromophenol, tributyltin oxide, triclocarban, triclosan, tridemorph, trimetrexate, undecylenic acid, validamycin, venturicidin, vinclozolin, vinyldithiin, vusion, xanthene, zinc borate, zinc pyrithione, zineb, ziram, voriconazole, itraconazole, posaconazole, fluconazole, ketoconazole, clotrimazole, isavuconazonium, miconazole, caspofungin, anidulafungin, micafungin, griseofulvin, terbinafine, flucytosine, terbinafine, nystatin, amphotericin b., and combinations thereof.

[0184] Examples of antivirals include, but are not limited to, afovirsen, alisporivir, anguslific acid, angustifodilactone, alovudine, beclabuvir, 2,3-bis(acetylmercaptomethyl)quinoxaline, brincidofovir, dasabuvir, docosanol, fialuridine, ibacitabine, imiquimod, inosine, inosine pranobex, interferon, metisazone, miltefosine, neokadsuranin, neotripterifordin, ombitasvir, oragen, oseltamivir, pegylated interferon, podophyllotoxin, radalbuvir, semapimod, tecovirimat, telbivudine, theaflavin, tilorone, triptofordin C-2, variecolol, ZMapp, abacavir, acyclovir, adefovir, amantadine, amprenavir, atazanavir, balavir, baloxavir marboxil, boceprevir, cidofovir, cobicistat, daclatasvir, darunavir, delavirdine, didanosine, docasanol, dolutegravir, doravirine, ecoliever, edoxudine, efavirenz, elvitegravir, emtricitabine, enfuvirtide, entecavir, etravirine, famciclovir, fomivirsen, fosamprenavir, foscarnet, fosnonet, famciclovir, favipravir, fomivirsen, foscavir, ganciclovir, ibacitabine, idoxuridine, indinavir, inosine, inosine pranobex, interferon type I, interferon type II, interferon type III, lamivudine, letermovir, letermovir, lopinavir, loviride, maraviroc, methisazone, moroxydine, nelfinavir, nevirapine, nitazoxanide, oseltamivir, peginterferon alfa-2a, peginterferon alfa-2b, penciclovir, peramivir, pleconaril, podophyllotoxin, pyramidine, raltegravir, remdesivir, ribavirin, rilpivirine, rimantadine, rintatolimod, ritonavir, saquinavir, simeprevir, sofosbuvir, stavudine, tarabivirin, telaprevir, telbivudine, tenofovir alafenamide, tenofovir disoproxil, tenofovir, tipranavir, trifluridine, trizivir, tromantadine, umifenovir, valaciclovir, valganciclovir, vidarabine, zalcitabine, zanamivir, zidovudine, and combinations thereof.

[0185] In some examples, the therapeutic agent can comprise an anticancer agent. In some examples, the therapeutic agent comprises a chemotherapeutic agent, an immunotherapeutic agent, or a combination thereof.

[0186] In some examples, the therapeutic agent can comprise a chemotherapeutic agent.

[0187] Chemotherapy is the treatment of cancer with one or more cytotoxic anti-neoplastic drugs (e.g., chemotherapeutic agents) as part of a standardized regimen. Chemotherapy may be given with a curative intent or it may aim to prolong life or to palliate symptoms. In some cases, it can be used in conjunction with other cancer treatments, such as radiation therapy, surgery, hyperthermia therapy, or a combination thereof. Examples of chemotherapeutic agents include, but are not limited to, 13-cis-Retinoic Acid, 2-Amino-6-Mercaptopurine, 2-CdA, 2-Chlorodeoxyadenosine, 5 -fluorouracil, 6-Tliioguanine, 6-Mercaptopurine, Accutane, Actinomycin-D, Adriamycin, Adrucil, Agrylin, Ala-Cort, Aldesleukin, Alemtuzumab, Alitretinoin, Alkaban-AQ, Alkeran, All-transretinoic acid, Alpha interferon, Altretamine, Amethopterin, Amifostine, Aminoglutethimide, Anagrelide, Anandron, Anastrozole, Arabinosylcytosine, Aranesp, Aredia, Arimidex, Aromasin, Arsenic trioxide, Asparaginase, ATRA, A vastin, BCG, BCNU, Bevacizumab, Bexarotene, Bicalutamide, BiCNU, Blenoxane, Bleomycin, Bortezomib, Busulfan, Busulfex, C225, Calcium Leucovorin, Campath, Camptosar, Camptothecin-11, Capecitabine, Carac, Carboplatin, Carmustine, Carmustine wafer, Casodex, CCNU, CDDP, CeeNU, Cerubidine, cetuximab, Chlorambucil, Cisplatin, Citrovorum Factor, Cladribine, Cortisone, Cosmegen, CPT-11, Cyclophosphamide, Cytadren, Cytarabine, Cytarabine liposomal, Cytosar-U, Cytoxan, Dacarbazine, Dactinomycin, Darbepoetin alfa, Daunomycin, Daunorubicin, Daunorubicin hydrochloride, Daunorubicin liposomal, DaunoXome, Decadron, Delta-Cortef, Deltasone, Denileukin diftitox, DepoCyt, Dexamethasone, Dexamethasone acetate, Dexamethasone sodium phosphate, Dexasone, Dexrazoxane, DIAD, DIC, Diodex, Docetaxel, Doxil, Doxorubicin, Doxorubicin liposomal, Droxia, DTIC, DTIC-Dome, Duralone, Efudex, Eligard, Ellence, Eloxatin, Elspar, Emcyt, Epirubicin, Epoetin alfa, Erbitux, Erwinia L-asparaginase, Estramustine, Ethyol, Etopophos, Etoposide, Etoposide phosphate, Eulexin, Evista, Exemestane, Fareston, Faslodex, Femara, Filgrastim, Floxuridine, Fludara, Fludarabine, Fluoroplex, Fluorouracil, Fluorouracil (cream), Fluoxymesterone, Flutamide, Folinic Acid, FUDR, Fulvestrant, G-CSF, Gefitinib, Gemcitabine, Gemtuzumab ozogamicin, Gemzar, Gleevec, Lupron, Lupron Depot, Matulane, Maxidex, Mechlorethamine, -Mechlorethamine Hydrochlorine, Medralone, Medrol, Megace, Megestrol, Megestrol Acetate, Melphalan, Mercaptopurine, Mesna, Mesnex, Methotrexate, Methotrexate Sodium, Methylprednisolone, Mylocel, Letrozole, Neosar, Neulasta, Neumega, Neupogen, Nilandron, Nilutamide, Nitrogen Mustard, Novaldex, Novantrone, Octreotide, Octreotide acetate, Oncospar, Oncovin, Ontak, Onxal, Oprevelkin, Orapred, Orasone, Oxaliplatin, Paclitaxel, Pamidronate, Panretin, Paraplatin, Pediapred, PEG Interferon, Pegaspargase, Pegfilgrastim, PEG-INTRON, PEG-L-asparaginase, Phenylalanine Mustard, Platinol, Platinol- AQ, Prednisolone, Prednisone, Prelone, Procarbazine, PROCRIT, Proleukin, Prolifeprospan 20 with Carmustine implant, Purinethol, Raloxifene, Rheumatrex, Rituxan, Rituximab, Roveron-A (interferon alfa-2a), Rubex, Rubidomycin hydrochloride, Sandostatin, Sandostatin LAR, Sargramostim, Solu-Cortef, Solu-Medrol, STI-571, Streptozocin, Tamoxifen, Targretin, Taxol, Taxotere, Temodar, Temozolomide, Teniposide, TESPA, Thalidomide, Thalomid, TheraCys, Thioguanine, Thioguanine Tabloid, Thiophosphoamide, Thioplex, Thiotepa, TICE, Toposar, Topotecan, Toremifene, Trastuzumab, Tretinoin, Trexall, Trisenox, TSPA, VCR, Velban, Velcade, VePesid, Vesanoid, Viadur, Vinblastine, Vinblastine Sulfate, Vincasar Pfs, Vincristine, Vinorelbine, Vinorelbine tartrate, VLB, VP-16, Vumon, Xeloda, Zanosar, Zevalin, Zinecard, Zoladex, Zoledronic acid, Zometa, Gliadel wafer, Glivec, GM-CSF, Goserelin, granulocyte colony stimulating factor, Halotestin, Herceptin, Hexadrol, Hexalen, Hexamethylmelamine, HMM, Hycamtin, Hydrea, Hydrocort Acetate, Hydrocortisone, Hydrocortisone sodium phosphate, Hydrocortisone sodium succinate, Hydrocortone phosphate, Hydroxyurea, Ibritumomab, Ibritumomab Tiuxetan, Idamycin, Idarubicin, Ilex, IFN-alpha, Ifosfamide, IL 2, IL- 11, Imatinib mesylate, Imidazole Carboxamide, Interferon alfa, Interferon Alfa-2b (PEG conjugate), Interleukin 2, Interleukin-11, Intron A (interferon alfa-2b), Leucovorin, Leukeran, Leukine, Leuprolide, Leurocristine, Leustatin, Liposomal Ara-C, Liquid Pred, Lomustine, L- PAM, L-Sarcolysin, Meticorten, Mitomycin, Mitomycin-C, Mitoxantrone, M-Prednisol, MTC, MTX, Mustargen, Mustine, Mutamycin, Myleran, Iressa, Irinotecan, Isotretinoin, Kidrolase, Lanacort, L-asparaginase, LCR, FAM-HYD-1, Marizomib (NPI-0052), Lenalidomide, Carfilzomib, Panobinostat, Quisinostat, Selinexor, Oprozomib, and combinations thereof. The anticancer agent can also include biopharmaceuticals such as, for example, antibodies.

[0188] Examples of suitable immunotherapeutic agents include, but are not limited to, alemtuzumab, cetuximab (ERBITUX), gemtuzumab, iodine 131 tositumomab, rituximab, trastuzamab (HERCEPTIN), and combinations thereof.

[0189] In some examples, the therapeutic agent can comprise an anti-inflammatory agent, such as steroidal and / or non-steroidal anti-inflammatory agents. Examples of steroidal anti¬ inflammatory agents include, but are not limited to, hydrocortisone, dexamethasone, prednisolone, prednisone, triamcinolone, methylprednisolone, budesonide, betamethasone, cortisone, and deflazacort, Examples of non-steroidal anti-inflammatory drugs include acetaminophen, aspirin, ibuprofen, naproxen, Celebrex, ketoprofen, tolmetin, etodolac, fenoprofen, flurbiprofen, diclofenac, piroxicam, indomethacin, sulindax, meloxicam, nabumetone, oxaprozin, mefenamic acid, and diflunisal.

[0190] In some examples, the therapeutic agent can comprise an analgesic. Examples of analgesics include, but are not limited to, 1-Iodomorphine; 3 -Hydroxymorphinan; 4- Methylpregabalin; A-366,833; ABT-202; Aceburic acid; Acefurtiamine; Acetaminosalol;

[0191] Acetyldihydrocodeine; Acetylmethadol; Adrenorphin; Alazocine; Algifen; Alimadol;

[0192] Alletorphine; Alphacetylmethadol; Alphamethadol; Amidorphin; Aminophenazone; Ampyrone; Amrutanjan (balm); Anacin; Anadin; Analgecine; Anazocine; Anileridine; Anilopam; Anodyne; Askit Powders; Aspergum; Aspirin; Axomadol; AZD0328; BC Powder; Befiradol; Benorilate; Betacetylmethadol; Betahydroxyfentanyl; Betamethadol; Bicifadine; Biphalin; Brorphine; Bucetin; Bucinnazine; Butalbital; Butinazocine; Butonitazine; Butorphanol; Cannabidiol;

[0193] Carbazocine; Cebranopadol; Chlorodyne; Chlorproethazine; Cinchophen; Cogazocine;

[0194] Conolidine; Conorfone; CR-4056; CR665; Dasolampanel; Deltorphin; Deltorphin I; DepoDur; Desmetramadol; Desomorphine; Dezocine; Diacetylnalorphine; Dichloralphenazone;

[0195] Difenamizole; Dimenoxadol; Dimepheptanol; Dimethylheptylpyran; Dinalbuphine sebacate; Dipipanone; Diproqualone; Dipyrocetyl; Dosulepin; DSP-2230; Embutramide; Enkephalinase inhibitor; Epibatidine; Epiboxidine; Eptazocine; Esteroni; Etazocine; Ethylketazocine;

[0196] Etodesnitazene; Etonitazepipne; Etonitazepyne; Etorphine; Famotidine; Faxeladol; Fedotozine; Fentanyl; Filenadol; Flumexadol; Flumizole; Fluproquazone; Frakefamide; Funapide;

[0197] Gabapentin; Gabapentin enacarbil; Gabapentinoid; Glafenine; Homofentanyl; Homprenorphine; Ibazocine; Ibuprofen; Incarvillateine; Indantadol; Isomethadone; Isotonitazene; Iso valine;

[0198] Kavalactone; Kelatorphan; Ketamine; Ketobemidone; Ketorfanol; Ketorolac; Lactucarium; Leconotide; Levallorphan; Levomepromazine; Levomethadone; Lufuradom; Magnesium salicylate; Mavatrep; Meconopsis horridula; Menabitan; Menthol; Menthoxypropanediol;

[0199] Meprobamate; Meseclazone; Metacetamol; Metamizole; Methoxyflurane; Metkefamide;

[0200] Metodesnitazene; Metonitazene; Mexiletine; Migraleve; Mirogabalin; Mitragyna speciosa; Moffett’s solution; Moramide intermediate; Morpheridine; Morphiceptin; Morphine;

[0201] Moxazocine; MP-2001; N-2'-Indolylnaltrexamine; Nabilone; Nafoxadol; Nalbuphine;

[0202] Nalmexone; Naproxen; Nefopam; Nexeridine; NFEPP; Nimesulide; Noracymethadol;

[0203] Norlevorphanol; Normethadone; Norpipanone; NS-11394; Oliceridine; Opiorphin; Opiranserin; Opium; Otenaproxesul; Oxilorphan; Paracetamol; Pethidine; PF-05089771; Phenacetin;

[0204] Phenazone; derivatives thereof; and combinations thereof.

[0205] In some examples, the therapeutic agent can comprise an analgesic, such as an opioid. Examples of opioids include, but are not limited to, (aZP)-Meprodine; (o / p) -Prodine; l-(4- Nitrophenylethyl)piperidylidene-2-(4-chlorophenyl)sulfonamide (W-18); 14- Cinnamoyloxycodeinone; 14-Ethoxy metopon; 14-Hydroxydihydrocodeine; 14-Hydroxymorphine; 14-Methoxymetopon; 14-Phenylpropoxy metopon; 18,19-Dehydrobuprenorpliine (HS-599); 18-Methoxycoronaridine; 1 -Bromocodeine; 1 -Chlorocodeine; 1-Iodomorphine Codeine-6-glucuronide; 1 -Nitrocodeine; 2,4-Dinitrophenylmorphine; 3-(3-Methoxyphenyl)-3-ethoxycarbonyltropane; 3-(dimethylamino)-2,2-dimethyl-l-phenylpropan-l-one; 3,14-Diacetyloxymorphone; 3,6-Dibutanoylmorphine; 3-Acetyloxymorphone; 3- Allylfentanyl; 3-Hydroxymorphinan; 3 -Methylfentanyl; 3-Methylthiofentanyl; 3-Monoacetylmorphine; 4-Chlorophenylpyridomorphinan; 4-Fluoropethidine; 4-Phenylfentanyl; 5,6-Dihydronorsalutaridine; 5,9 alpha-diethyl-2-hydroxybenzomorphan (5,9-DEHB); 6- Acetyldihydromorphine; 6-Keto Nalbuphine; 6-Methyldihydromorphine; 6- Methylenedihydrodesoxymorphine; 6-Monoacetylcodeine; 6-Monoacetylmorphine; 6- Nicotinoyldihydromorphine; 7 -Acetoxymitragynine; 7 -Hydroxymitragynine; 7-PET; 7- Spiroindanyloxymorphone; 8, 14-Dihydroxydihydromorphinone; 8-Carboxamidocyclazocine (8-CAC); Acetorphine; Acetoxyketobemidone; Acetylcodone; Acetyldihydrocodeine;

[0206] Acetylmethadol; Acetylmorphone; Acetylpropionylmorphine; AD-1211; ADE-5859; AH-7921; Aknadinine; Akuammidine; Akuammine; Alazocine; Alfentanil; Alimadol; Alletorphine (N-allyl-noretorphine); Allylnorpethidine; Allylprodine; Alphaacetylmethadol; Alphamethadol; Alvimopan; Amentoflavone; Anazocine; Anileridine; Anilopam +HC1; Asimadoline; Axomadol; Azaprocin; AZD-2327; Azidomorphine; BDPC; Benzethidine; Benzhydrocodone;

[0207] Benzylfentanyl; Benzylmorphine; Betacetylmethadol; Betamethadol; Bezitramide;

[0208] Bisnortilidine; Bremazocine; Brifentanil; BRL-52537; Bromadol; Bromadoline; Bromocodide; Bromoisopropropyldihydromorphinone; Bromomorphide; BU-48; Buprenorphine;

[0209] Buprenorphine-3-glucuronide; Butinazocine; Butorphanol; Butyrfentanyl; BW373U86;

[0210] Carbazocine; Carfentanil; Carperidine; Cephakicine; Cephasamine; Chlornaltrexamine;

[0211] Chlorodihydrocodide; Chloromorphide; Chloroxymorphamine; Ciprefadol; Ciramadol;

[0212] Clonitazene; Codeine; Codeine methylbromide; Codeine-N-oxide; Codeine-N- oxide (genocodeine); Codeinone; Codide; Codoxime; Cogazocine; Conorfone (codorphone); Coronaridine; Cyclazocine; Cyclorphan; Cyprenorphine; Cyprodime; Cyproterone acetate; Desmethylclozapine; Desmethylmoramide; Desmethylprodine (MPPP); Desocodeine Desomorphine (dihydrodesoxymorphine); Dextromethadone; Dextromoramide;

[0213] Dextropropoxyphene (propoxyphene); Dezocine; Diacetyldihydromorphine (dihydroheroin, acetylmorphinol); Diampromide; Dibenzoylmorphine; Dibutyrylmorphine; Diethylthiambutene; Difenoxin; Diformylmorphine; Dihydrocodeine; Dihydrocodeine; Dihydrodesoxycodeine (desocodeine); Dihydroetorphine; Dihydroisocodeine; Dihydromorphine; Dimenoxadol;

[0214] Dimepheptanol (racemethadol); Dimethylmorphine (6-O-Methylcodeine);

[0215] Dimethylthiambutene; Dioxaphetyl butyrate; Diphenoxylate; Dipipanone;

[0216] Dipropanoylmorphine; Doxpicomine; DPI- 221; DPI-287; DPI-3290; Drotebanol; Droxypropine; Embutramide; Enadoline; Eptazocine; Eseroline; Etazocine; Ethoheptazine;

[0217] Ethyldihydromorphine; Ethylketazocine; Ethylmethylthiambutene; Ethylmorphine (dionine); Etonitazene; Etorphine; Etoxeridine (carbetidine); Faxeladol; FE 200665; Fedotozine;

[0218] Fenfangjine G; Fentanyl; Fluorophen; Furethidine; Gemazocine; GR-89696; Herkinorin;

[0219] Heroin ( diacetylmorphine); Heroin-7, 8-oxide; Heterocodeine; Hodgkinsine; Homprenorphine; Hydrocodone; Hydromorphinol; Hydromorphone; Hydroxy codeine; Hydroxypethidine (bemidone); HZ-2; Ibazocine; IBNtxA; Ibogaine; IC-26; ICI-199,441; ICI-204,448; Isoaminile; Isocodeine; Isomethadol; Isomethadone; Isotonitazene; Ketamine; Ketazocine; Ketobemidone; Ketorfanol; KNT-42; Kolokol-1; Lefetamine; Levacetylmethadol; Levargorphan;

[0220] Levoisomethadone; Levomethadone; Levomethorphan; Levomoramide; Levophenacylmorphan; Levopropoxyphene; Levorphanol; Lofentanil; Loperamide; LPK-26; LS-115509; Lufuradom; Matline; MCOPPB; Menthol; Meperidine-N-oxide; Meptazinol; Metazocine; Metethoheptazine; Methadone; Metheptazine; Methorphan (racemethorphan); Methyldesorphine;

[0221] Methyldihydromorphine (dihydroheterocodeine); Methyldihydromorphinone;

[0222] Methylketobemidone; Metofoline; Metonitazene; Metopon; Mirfentanil; Mitragynine;

[0223] Mitragynine pseudoindoxyl; Morphanol (racemorphanol); Morphenol; Morpheridine; Morphine; Morphine methylbromide; Morphine-6-glucuronide; Morphine-N -oxide; Morphine-N-oxide (genomorphine); Morphinone; Morphol; Moxazocine; MT-45; MT-7716; Myrophine; Nalbuphine; Nalbuphone; Nalfurafine; Nalorphine; Nalorphine dinicotinate; Naltrexol; N-cyclopropylmethylnoretorphine; Nepenthone; Nexeridine; Nicocodeine; Nicodicodeine;

[0224] Nicomorphine; N-Methylcarfentanil; N-Methylmorphinan; NNC 63-0532; Noracymethadol; Norbuprenorphine; Norbuprenorphine-3-glucuronide; Norcodeine; Noribogaine;

[0225] Norlevorphanol; Normethadone; Normorphine; Noroxymorphone; Norpipanone;

[0226] Norpropoxyphene; Nortilidine; N-Phenethyl-14-ethoxymetopon; N-Phenethyl-14-ethoxy metopon; N -Phenethyl nordesomorphine; N-Phenethylnormorphine; Ocfentanil; O-Desmethyltramadol; Ohmefentanyl; Opium; Oripavine; Oxilorphan; Oxpheneridine (carbamethidine); Oxycodone; Oxymorphazone; Oxymorphol; Oxymorphone; Pantopon;

[0227] Papaveretum (Omnopon); Parafluorofentanyl; Pentamorphone; Pentazocine; PEPAP; Pericine; Pethidine (meperidine); Phenadone; Phenadoxone (heptazone); Phenampromide; Phenaridine; Phenazocine; Phencyclidine; Pheneridine; Phenomorphan; Phenoperidine; Pholcodine (morpholinylethylmorphine); Picenadol; Piminodine; Piperidyl thiambutene; Piritramide;

[0228] Prodilidine; Profadol; Proglumide; Proheptazine; Properidine (ipropethidine); Propiram;

[0229] Propylketobemidone; Prosidol; Proxorphan; Pseudoakuammigine; Pseudomorphine;

[0230] Pyrrolidinylthiambutene; Pyrroliphene; PZM21; Quadazocine; R-30490; R-4066;

[0231] Racemoramide; RAM-378; Remifentanil; Ro-1539; Ro4-1539; Ro64-6198; Ro65-6570; RWJ-394,674; Salvinorin A; Salvinorin B ethoxymethyl ether; Salvinorin B methoxymethyl ether; Sameridine; SB-612,111; SC-17599; Seniorphone; SKF-10047; SNC-80; SoRl-9409;

[0232] Spiradoline; SR-16435; SR-8993; Sufentanil; TAN-67; Tannagine; Tapentadol; Tetrapon;

[0233] Thebacon; Thebacon (acetyldihydrocodeinone, dihydrocodeinone enol acetate); Thebaine; Thenylfentanyl; Thevinone; Thiambutene; Thiazocine; Thienorphine; Thiobromadol (C-8813); Thiofentanyl; Tifluadom; Tilidine; Tonazocine; Tramadol; Transisocodeine; Trefentanil;

[0234] Trimebuline; Trimeperidine (promedol); U-47700; U-50,488; U-69,593; Viminol; Volazocine; Zenazocine; a-Chlorocodide; a-Chloromorphide; a-hydrocodol; a-Methylacetylfentanyl; a-Methylfentanyl; a-Methyl thiofentanyl; P-Chlorocodide; P-hydroxyfentanyl; β-hydroxythiofentanyl; p-Methylfentanyl; β-Akuammigine; derivatives thereof; and combinations thereof.

[0235] In some examples, the therapeutic agent can comprise an analgesic, such as a local anesthetic. Examples of local anesthetics include, but are not limited to, Ambucaine, Amylocaine, Articaine, Benzocaine, Benzonatate, Bupivacaine, Butacaine, Butanilicaine, Chloroprocaine, Cinchocaine (dibucaine), Cocaine, Cyclomethy caine, Dibucaine, Dimethocaine (larocaine), Diperodon, Etidocaine, Eucaine, Eugenol, Foniocaine, Fotocaine, Hexylcaine, Hydroxyprocaine, Isobucaine, Levobupivacaine, Lidocaine (lignocaine), Menthol, Mepivacaine, Meprylcaine, Metabutoxycaine, Neosaxitoxin, Nitracaine, Orthocaine, Oxetacaine (oxethazaine), Oxybuprocaine, Paraethoxycaine, Phenacaine, Piperocaine, Pramocaine, Prilocaine, Procainamide, Procaine (novocaine), Proparacaine, Propoxycaine, Pyrrocaine, Quinisocaine (domethisoquin), Ropivacaine, Saxitoxin, Spilanthol, Tetracaine (amethocaine), Tetrodotoxin, Tolycaine, Trimecaine, Tropacocaine; derivatives thereof; and combinations thereof.

[0236] In some examples, the therapeutic agent can comprise a growth factor (e.g., (PDGF, TGF-P, etc.).

[0237] In some examples, the therapeutic agent can comprise an anti-fibrotic agent.

[0238] In some examples, the device is configured to be stable for an amount of time after the device is implanted in the subject. As used herein, “stable” means that 10 wt% or less (e.g., 9% or less, 8% or less, 7% or less, 6% or less, 5% or less, 4% or less, 3% or less, 2% or less, or 1 % or less) of the device biodegrades over the selected time period after the device is implanted in the subject. In some examples, the device is configured to be stable for 6 months or more, 9 months or more, or 12 months or more.

[0239] In some examples, the device is configured to biodegrade over an amount of time after the device is implanted in the subject. In some examples, the device is configured to biodegrade over 12 to 36 months.

[0240] In some examples, the device is anatomically designed for the subject.

[0241] In some examples, the device is implantable in the subject.

[0242] In some examples, the device is configured to conforms to anatomical contours, ensuring uniform tension distribution and long-term ptosis prevention. In some examples, the plurality of radial fenestrations are configured to balance adaptability with material integrity, focusing on areas requiring maximum projection.

[0243] In some examples, the device comprises the device of any one of Figure 1 - Figure 31. In some examples, the device has a surface area which can be selected in view of the anatomical location and dimensions thereof. For example, the surface area of the device can be selected based on the surface area of the anatomical location where the device is to be inserted. For example, the device and the anatomical location can each have an average lateral dimension, and the average lateral dimension of the device can be selected to be comparable to the average lateral dimension of the anatomical location where the device is to be inserted.

[0244] When the device is used to support at least a portion of a breast or breast implant, the surface area of the device can be selected in view of the surface area of said portion of the breast or breast implant. For example, if the surface area of the device is too large relative to the portion of the breast or breast implant, the device will be too loose and can lead to undesirable rippling. Alternatively, if the surface area of the device is, for example, too small relative to the portion of the breast or breast implant, the device will be too tight, which can lead to undesirable effects.

[0245] Kits

[0246] Also disclosed herein are kits comprising any of the devices disclosed herein disposed within a sterile package. In some examples, the kit further comprises a pre-marking template, a stapling device, or a combination thereof.

[0247] Methods of Making

[0248] Also disclosed herein are methods of making any of the devices disclosed herein.

[0249] In some examples, the method comprises introducing the plurality of radial fenestrations in the biocompatible material; forming the upper and / or lower edge of the device; forming the notches and / or tabs; forming the slits; or a combination thereof.

[0250] In some examples, the method comprises making the device based on an anatomical image of a subject. In some examples, the method further comprises collecting the anatomical image of the subject.

[0251] In some examples, the method further comprises anatomically designing the device for the subject.

[0252] Methods of Use

[0253] Also disclosed herein are methods of use of any of the devices di sclosed herein.

[0254] In some examples, the method is a method of treating a subject in need thereof. In some examples, the method comprises implanting any of the devices disclosed herein into the subject. Also disclosed herein are methods of implanting a scaffold comprising positioning any of the devices disclosed herein into a subject, folding the tabs posteriorly along the folding edge, and passing sutures from an anterior surface through the slits or openings and through the folded tabs into the chest wall, thereby securing the device without parachute sutures.

[0255] In some examples, the device is implanted into at least a portion of a breast of the subject.

[0256] In some examples, the method comprises breast reconstruction, augmentation (e.g., full or partial breast reconstruction or augmentation), and / or cosmetic improvement such as after a lumpectomy or mastectomy.

[0257] In some examples, the method comprises one stage or two stage implant based breast reconstruction.

[0258] In some examples, the method further comprises anatomically designing the device for the subject.

[0259] In some examples, the device is secured after implantation. The device can be secured using any suitable means, including, but not limited to, adhesives / tissue glues, absorbable tacks, barbed sutures, suture anchors, clips, ultrasonic / thermal bonding, and combinations thereof.

[0260] In some examples, the device is secured after implantation, for example using sutures, staples, etc.

[0261] In some examples, the methods can comprise breast reconstruction (e.g., full or partial breast reconstruction) and treatment of an oncological disorder, such as breast cancer. In some examples, the devices can further include a therapeutic agent, for example for treatment of the oncological disorder.

[0262] For the treatment of oncological disorders, the devices disclosed herein can be administered to a patient in need of treatment in combination with other antitumor or anti-cancer substances and / or with radiation and / or photodynamic therapy and / or with surgical treatment to remove a tumor. These other substances or treatments can be given at the same as or at different times from the devices disclosed herein.

[0263] A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

[0264] The examples below are intended to further illustrate certain aspects of the systems and methods described herein and are not intended to limit the scope of the claims. EXAMPLES

[0265] The following examples are set forth below to illustrate the methods and results according to the disclosed subject matter. These examples are not intended to be inclusive of all aspects of the subject matter disclosed herein, but rather to illustrate representative methods and results. These examples are not intended to exclude equivalents and variations of the present invention, which are apparent to one skilled in the art.

[0266] Efforts have been made to ensure accuracy with respect to numbers (e.g., amounts, temperature, etc.) but some errors and deviations should be accounted for. Unless indicated otherwise, parts are parts by weight, temperature is in °C or is at ambient temperature, and pressure is at or near atmospheric. There are numerous variations and combinations of measurement conditions, e.g., component concentrations, temperatures, pressures and other measurement ranges and conditions that can be used to optimize the described process.

[0267] Example 1 - Suspension Arc Scaffold with Anchoring Tabs and Radial Fenestrations for Lower Pole Breast Soft Tissue Support

[0268] Described herein is a specially designed supportive structure for use in breast reconstruction and aesthetic surgery. It provides enhanced support to the lower portion of the breast, helping to maintain a natural, lifted shape over time. The device has a unique, symmetrical shape with radial cutouts (fenestrations) that allow it to adapt to the natural shape of the breast. It also includes tabs for stitching, which help keep it securely in place, and notches that guide the surgeon in placing it accurately. Tills design is intended to prevent issues like sagging by providing a stable, supportive “hammock” for the lower breast, making it particularly useful in surgeries where long-term aesthetic results are important.

[0269] The device is constructed as a concave, symmetrical arc-shaped support structure designed to fit within the lower pole of the breast. The symmetrical design allows it to be used on either side of the chest without the need for separate right and left versions, as it can accommodate materials that have polarity. One side of the material may integrate with tissue more readily, and this symmetry eliminates the need for different configurations, simplifying surgical application.

[0270] An example device is shown in Figure 1. Structural features of the device include, but are not limited to:

[0271] • Radial Fenestrations: Positioned along the arc, these small cutouts allow the device to expand horizontally, adapting to the breast’s natural shape and projection while resisting vertical stretch. This feature helps prevent downward sagging (ptosis), maintaining the desired breast contour. • Suturing Tabs: The device includes two outer tabs at each end, enabling it to be securely anchored in a “hammock” or sling-like configuration that provides stable support for the lower pole. These tabs make it easy for surgeons to suture the device into place, ensuring stability and durability.

[0272] • Orientation Notches: The device features a central medial notch and two lateral notches. The medial notch assists in aligning the device correctly, while the lateral notches facilitate precise orientation and placement. These notches guide the surgeon in positioning the device accurately for optimal support and integration with the surrounding tissue.

[0273] The device can be made from any suitable material, such as a biocompatible, possibly bioresorbable material, which will gradually integrate with the surrounding tissue over time, providing both immediate and lasting support. The concave, arc-shaped design, combined with the radial fenestrations, tabs, and notches, works to optimize the aesthetic and structural outcome of breast reconstructions.

[0274] An example structure and design feature are visualized in diagrammatic form in Figure 1. Next steps involve prototyping, material testing, and refining the design based on initial testing results. Future stages may involve in vitro testing to evaluate integration with tissue, followed by in vivo testing to assess long-term stability and effectiveness in supporting breast tissue post-surgery.

[0275] The devices described herein addresses the issue of maintaining long-term structural support in the lower pole of the breast, an area prone to sagging or ptosis following reconstructive or aesthetic procedures. Traditional methods lack specific structural features to provide lasting support in this region, often resulting in downward displacement over time. This device overcomes these limitations by offering a symmetrical design with radial fenestrations that allow for horizontal adaptability and limited vertical stretch, thus preventing sagging. The suturing tabs and orientation notches provide an intuitive means for accurate placement and secure anchoring, ensuring stable support and orientation during and after surgery. By accommodating materials with polarity, it further simplifies the manufacturing process by eliminating the need for separate right and left versions.

[0276] Traditional Methods: Existing breast support devices are often generic in design and lack the specialized structural adaptations required for long-term lower pole support, especially following reconstructive or aesthetic procedures. Some current options are asymmetrical, meaning they require separate configurations for the right and left breasts, which can complicate both manufacturing and surgical application and are not designed for specific lower pole breast support. Most options are typically simple and elliptical, which limits their adaptability and effectiveness for creating natural contours.

[0277] Current devices often lack important features such as radial fenestrations, which allow for controlled horizontal stretch to conform to the breast’s natural profile projection while preventing vertical stretch. This omission can lead to progressive sagging or ptosis over time, as the device may not provide the necessary resistance to downward pull, necessary in the lower pole region.

[0278] Moreover, traditional designs do not include dedicated tabs for secure anchoring, nor orientation features like medial or lateral notches, which are important for precise placement and stabilization within the tissue. The absence of these features can result in inconsistent placement and support, potentially affecting aesthetic outcomes.

[0279] Unlike the symmetrical, curved design described herein, which conforms naturally to the most projecting part of the breast, traditional devices typically have a flat, uniform upper edge that does not adapt as effectively to the natural curvature of the breast. This flat design may reduce the overall aesthetic outcome by failing to support the breast’s contour optimally, especially in the upper and lower poles.

[0280] Figure 1 shows a schematic illustration of an example device according to one implementation.

[0281] Users or recipients that can benefit from this technology include breast reconstructi ve surgeons and their patients.

[0282] Example 2 - Concave Arc Scaffold with Adaptable Fenestrations, Symmetrical Design, and Advanced Anchoring for Soft Tissue Support

[0283] Reconstructive and cosmetic surgeries require advanced solutions for long-term structural support of soft tissues, particularly in areas prone to ptosis, such as the lower pole of the breast. Traditional solutions — such as meshes, ADM scaffolds, and bioresorbable materials — fall short in their adaptability, structural integrity, or ease of use during surgery. These limitations result in suboptinial outcomes, including sagging, migration, or inefficient implantation processes.

[0284] Described herein is a concave arc-shaped scaffold that overcomes these challenges through its adaptable design, advanced fenestrations, and integrated anchoring mechanisms, ensuring precise placement, long-term support, and anatomical conformity. The scaffold’s modularity and material compatibility further enhance its versatility for use in a variety of surgical applications. This scaffold is a concave arc-shaped structure designed for soft tissue support. It features:

[0285] • Adaptable fenestrations for horizontal expansion and prevention of vertical stretch. • Symmetrical design for universal bilateral application, reducing complexity in manufacturing and surgical use.

[0286] • Integrated anchoring mechanisms such as tabs and slits for precise orientation and secure fixation.

[0287] • Material compatibility with ADM, bioresorbable polymers, and hybrid composites for optimal tissue integration and structural support.

[0288] • Dynamic modular configurations for patient-specific applications.

[0289] These features collectively address deficiencies in existing scaffolds and support superior functional and aesthetic outcomes.

[0290] Described herein are:

[0291] 1. Concave Arc Scaffold: A scaffold with a concave arc shape, designed for anatomical conformity and uniform load distribution, adaptable for soft tissue support.

[0292] 2. Symmetrical Design: A symmetrical scaffold structure enabling universal use on bilateral anatomical sites without requiring separate configurations.

[0293] 3. Staggered Fenestrations: A fenestration pattern comprising staggered radial slits, allowing controlled horizontal expansion while preventing vertical stretch for long-term stability.

[0294] 4. Anchoring Tabs and Slits: Integrated tabs and slits for orientation and anchoring, facilitating precise suturing or stapling to surrounding tissue or underlying structures.

[0295] 5. Dynamic Adaptation: A scaffold incorporating dynamic shape-memory materials or adjustable configurations to conform intraoperatively or postoperatively to anatomical variations.

[0296] 6. Modularity: A modular scaffold design featuring interchangeable or extendable components for patient-specific customization and adaptability.

[0297] 7. Multi-Arc Configurations: A scaffold with multiple interconnected arcs, compound curvatures, or radii for enhanced adaptability to varied anatomical regions.

[0298] 8. Variable Material Composition: A scaffold compatible with ADM, bioresorbable polymers, and hybrid composites, ensuring biocompatibility and tissue integration.

[0299] 9. Scaffold-Tool System: A system comprising the scaffold and associated surgical tools, including pre-marking templates or stapling devices, to streamline placement and enhance precision. 10. Universal Application: A scaffold suitable for various anatomical regions, including but not limited to the breast, abdominal wall, or pelvic floor.

[0300] Detailed Description:

[0301] 1. Shape Design:

[0302] • 'The scaffold features a concave arc that conforms to anatomical contours, ensuring uniform tension distribution and long-term ptosis prevention.

[0303] • Variable radii allow customization for different implant sizes or patient anatomies.

[0304] 2. Fenestration Patterns:

[0305] • Staggered radial fenestrations are strategically positioned to balance adaptability with material integrity, focusing on areas requiring maximum projection. 3. Symmetry:

[0306] • Symmetry allows universal application, simplifying surgical orientation and reducing the need for separate configurations.

[0307] 4. Anchoring Mechanisms:

[0308] • Tabs and slits along the scaffold perimeter provide dual functionality for orientation and anchoring, enabling suturing or use with absorbable staples.

[0309] • Additional anchoring innovations, such as integrated slots for modular extensions, support patient-specific adaptations.

[0310] 5. Material Compatibility:

[0311] • The scaffold supports diverse material options, such as:

[0312] • ADM for biocompatibility and tissue integration.

[0313] • Bioresorbable Polymers for gradual degradation and structural support.

[0314] • Hybrid Materials for strength and integration.

[0315] 6. Dynamic and Modular Configurations:

[0316] • Features such as shape-memory materials or adjustable components enable intraoperative or postoperative adaptation, enhancing surgical flexibility.

[0317] Example 3 - Arc Scaffold with Anchor Mechanism

[0318] Arc Scaffold Designed for Lower Pole Support of the Breast

[0319] An example device is shown in Figure 1:

[0320] - 4 tabs that are used for securing the scaffold to chest

[0321] - Tabs also help in orientation in the breast pocket - The linear fenestrations are designed for lateral expansion, minimizing vertical expansion to prevent ptosis

[0322] Additional fenestrations are designed to facilitate anchoring the tabs after they are turned under with sutures or anchors, simplifying the surgical approach to precise scaffold inset (Figure 2)

[0323] A posterior view of an example device is shown in Figure 3, where the yellow lines delineate sutures that are placed through the fenestrations to anchor the tabs posteriorly

[0324] A feature of the lower pole breast support scaffold described herein is an innovative modification aimed at simplifying the anchoring process and ensuring precise placement of the scaffold against the chest wall. This enhancement incorporates additional fenestrations along a dedicated line near the base of the scaffold, specifically designed to enable direct suturing to the posterior tabs. The improvement addresses key challenges associated with traditional anchoring techniques, such as the reliance on parachute sutures, which can be time-consuming and imprecise.

[0325] Features of the Devices:

[0326] 1. Additional Fenestrations for Direct Suturing:

[0327] • A line of fenestrations has been integrated into the scaffold design along the posterior edge, directly aligning with the posterior tabs. These fenestrations allow sutures to pass through the scaffold material, connecting the posterior tabs directly to the chest wall.

[0328] • lliis feature eliminates the need for complex parachute sutures, which traditionally involve securing the scaffold at multiple points before achieving stable placement.

[0329] 2. Turned-Under Posterior Tabs:

[0330] • The posterior tabs are designed to be folded under during the procedure, creating a stable base for anchoring the scaffold. The alignment of the new fenestrations with these tabs ensures that sutures can be precisely placed for a secure attachment.

[0331] • This configuration also minimizes the risk of scaffold migration or misalignment during or after surgery.

[0332] 3. Simplified Surgical Inset:

[0333] • The new fenestrations and tab design streamline the surgical workflow by allowing direct suturing without the need for additional tools or techniques. Surgeons can achieve precise placement quickly, reducing operative time and increasing the reliability of the scaffold’s positioning.

[0334] • This also enhances the scaffold’s ability to contour naturally to the chest wall, further supporting the lower pole of the breast

[0335] 4. Enhanced Scaffold Stability:

[0336] • The direct suturing mechanism ensures a firmer connection between the scaffold and the chest wall, improving overall stability. Tills feature is particularly beneficial for maintaining long-term lower pole support, even under gravitational or mechanical forces post-surgery.

[0337] • The combination of radial fenestrations, which allow lateral expansion, and vertical stability provided by the new anchoring method helps maintain the scaffold’s shape and effectiveness over lime.

[0338] 5. Aesthetic and Functional Improvements:

[0339] • By securing the posterior tabs through the fenestrations, the scaffold is better integrated into the tissue environment, reducing the likelihood of visible contour irregularities.

[0340] • This enhancement ensures the scaffold remains in the optimal position for supporting the breast’s natural projection and preventing ptosis.

[0341] Advantages Over Traditional Techniques:

[0342] • Time Efficiency: Eliminates the need for parachute sutures, reducing surgical complexity and time required for scaffold placement.

[0343] • Precision Placement: Ensures the scaffold aligns perfectly with the chest wall and breast contour, improving both functional and aesthetic outcomes.

[0344] • Stability: Provides a more secure attachment to the chest wall, minimizing the risk of scaffold displacement over time.

[0345] • Ease of Use: Simplifies the surgical procedure, making the scaffold easier to work with for surgeons, especially in complex reconstructions.

[0346] This improvement represents a significant advancement in the scaffold’s functionality and usability, making it a more effective and practical solution for lower pole breast support in both reconstructive and aesthetic procedures. Example 4

[0347] The disclosure provides arc-shaped scaffolds featuring (i) openings arranged to create directional, anisotropic expansion, (ii) a symmetry that enables bilateral use, including with polarity-sensitive materials and (iii) an anchoring system comprising posterior tabs and anterior fenestrations / openings that permit direct suturing to underlying tissue without parachute sutures.

[0348] An example device is shown in Figure 1.

[0349] The device can be made from any suitable material, such as ADM or any biodegradable biocompatible material. The composition of the device can be selected in view of a variety of considerations, such as the size of device (e.g., the size of an underlying implant or breast) and / or the desired shape control. For example, the device can be made from a biocompatible material that, in the absence of the fenestrations, is not completely elastic and / or is less pliable. In some examples, the device can be made from a mesh.

[0350] In some examples, the thickness of the material of the device can be selected in view of a variety of considerations, such as the size of device (e.g., the size of an underlying implant or breast) and / or the desired shape control. For example, the thickness of the material can be selected to provide the desired tensile strength and / or shape control.

[0351] The device includes radial fenestrations. The device can, for example, comprise firm collagen. In order to conform 2D firm collagen to 3D sphere point of max expansion of the breast, at least a portion of the plurality of the radial fenestrations are located towards the top of the device where the most expansion is desired and the radial fenestrations are staggered to allow maximum opening without weakening the device. The number, location, size, and / or shape of the radial fenestrations can be selected in view of a variety of considerations, such as the size of device (e.g., the size of an underlying implant or breast) and / or the desired shape control. For example, the device can have more radial fenestrations for more projection and / or a larger cup size.

[0352] The device can be secured with sutures, such as parachute sutures, anchors, resorbable stables, etc.

[0353] The device can include a curved or arc shaped top portion, which can avoid banding effect.

[0354] In some examples, the device comprises the plurality of radial fenestrations and the arc chape. For example, the device can be secured by attachments along the bottom edge of the device.

[0355] In some examples, the device further includes one or more notches and one or more tabs. The device can include one or more notches (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, or 7 or more). The number of notches can be selected in view of a variety of considerations. The device material is expensive so the notches can be designed to minimize discard while maximizing use of space and desired shape control. The number, location, size, and / or shape of the notches can be selected in view of a variety of considerations, such as the size of device (e.g., the size of an underlying implant or breast) and / or the desired shape control. For example, the device can have more notches for a larger device or cup size. The notches can be designed such that the tabs do not overlap when tucked in to conform to the 3D curvature / projection of the breast.

[0356] In some examples, the device is ready to use as-is by a surgeon, e.g. the device does not need to be cut or shaped before implantation into a patient. However, in some example, the device can be further cut or shaped by a surgeon if desired.

[0357] The device can include one or more tabs (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, or 8 or more). The number of are delineated by the number of notches. The number of tabs can be selected in view of a variety of considerations. The number, location, size, and / or shape of the tabs can be selected in view of a variety of considerations, such as the size of device (e.g., the size of an underlying implant or breast) and / or the desired shape control. For example, the device can have more tabs for a larger device or cup size. The tabs can be designed such that they do not overlap when tucked in to conform to the 3D curvature / projection of the breast. In some examples, the number, location, size, and / or shape of the tabs can be selected in view of the size of device (e.g., the size of an underlying implant or breast), for example to accommodate a sufficient number of sutures, anchors, staples, etc. to securely attach the device in the patient. For example, the size of the tabs can accommodate 2 sutures per tab as shown in Figure 3, which can be stable. In some examples, the number of tabs can be increased, such that each tab accommodates a single suture, but the increase in the number of tabs still provides for sufficient device attachment strength and stability.

[0358] Photographs of example devices are shown in Figure 25 - Figure 27.

[0359] Example 5

[0360] Disclosed herein are devices configured to be inserted into an anatomical location of a subject.

[0361] In some examples, the devices can comprise: a biocompatible material having an upper edge, a lower edge, and a thickness, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape; and a plurality of radial fenestrations, each of the plurality of radial fenestrations perforating the thickness of the biocompatible material. In some examples, the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject. In some examples, the device provides enhanced support at the anatomical location.

[0362] In some examples, the device is symmetrical.

[0363] In some examples, the device is configured to be elastic along a direction (e.g. horizontally), but have minimal elasticity perpendicular to said direction (e.g. vertically).

[0364] In some examples, at least a portion of the plurality of the radial fenestrations are located towards the upper edge of the device where the most expansion is desired.

[0365] In some examples, the radial fenestrations are staggered to allow maximum opening without weakening the device.

[0366] In some examples, the number, location, size, and / or shape of the radial fenestrations are selected in view the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0367] In some examples, the device further comprises one or more notches (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, or 7 or more) in the lower edge, such that the device further comprises a plurality of tabs (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, or 8 or more) along the lower edge. In some examples, the device includes 3 notches and 4 tabs.

[0368] In some examples, the notches and tabs are configured to provide dual functionality for orientation and anchoring.

[0369] In some examples, the number, location, size, and / or shape of the notches are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0370] In some examples, the notches are configured such that the tabs do not overlap when tucked in to conform to the 3D curvature / projection of the anatomical location.

[0371] In some examples, the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0372] In some examples, the tabs are configured such that they do not overlap when tucked in to conform to the 3D curvature / projection of the breast.

[0373] In some examples, the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ), for example to accommodate a sufficient number of sutures, anchors, staples, etc. to securely attach the device in the subject after insertion at the anatomical location. In some examples, the biocompatible material comprises ADM, a bioresorbable polymer, a composite material, or a combination thereof.

[0374] In some examples, the biocompatible material comprises a polymer such as a bioresorbable polymer, collagen, or a combination thereof.

[0375] In some examples, the biocompatible material comprises a shape-memory material. In some examples, the biocompatible material comprises a biological matrix. In some examples, the biological matrix is derived from human dermis, animal dermis, or animal material. In some examples, the biological matrix comprises FlexHD pliable ADM, FlexHD pliable MAX ADM, AlloDerm®, DermACELL (e.g., DermACELL AWM®, etc.), porcine ADM, STRATTICE®, CORTIVA™ (e.g., CORTIVA™ allograft dermis), ALLOMAX™, SurgiMend®, ARl’IA™, or a combination thereof.

[0376] In some examples, the biocompatible material comprises vicryl mesh, gortex, poly(4- Hydroxybuterate) (e.g., Galaflex), Polydioxanone (PDO) (e.g., Durasorb), polyglycolic acid trimethylene carbonate (PGA- PMC) (e.g., TIGR matrix), silk (e.g., SERI scaffold), polypropylene and / or polyglycolic acid (e.g., OviTex®), or a combination thereof.

[0377] In some examples, the device is reversible (e.g., posterior and anterior surfaces are substantially the same).

[0378] In some examples, the device has a posterior surface and an anterior surface, the posterior surface and the anterior surface being different.

[0379] In some examples, the device is configured to support and / or reshape at least a portion of an organ and / or at least a portion of an implant when inserted into the anatomical location of the subject.

[0380] In some examples, the device has a two dimensional shape that can stretch to a three dimensional shape that conforms to support and / or reshape an organ and / or an implant when inserted into the anatomical location of the subject.

[0381] In some examples, the anatomical location comprises a breast, a buttock, abdominal wall, or pelvic floor of the subject.

[0382] In some examples, the anatomical location comprises a breast of the subject.

[0383] In some examples, the device is configured to support at least a portion of a breast or at least a portion of a breast implant.

[0384] In some examples, the device is for facilitating reconstruction, augmentation, and / or cosmetic improvement of a breast, the breast having an upper pole, a lower pole, a most projecting portion, and an inframammary fold, wherein the device is configured to support and / or reshape at least a portion of the lower pole. In some examples, the device is configured to be positioned such that the upper edge is positioned towards the most projecting portion and extending inferiorly to the lower edge positioned towards the inframammary fold.

[0385] In some examples, the device is configured to be utilized with a breast implant. In some examples, the device is configured to cover a portion of the breast implant. In some examples, in use, the device is positioned prepectorally or postpectorally, anterior to the breast implant. In some examples, the size and / or shape of the device is selected based on the volume and / or shape of the breast implant. In some examples, the breast implant has an intra-operative fill volume of from 0 cubic centimeters (cc) to 1500 cc.

[0386] In some examples, the device is a single piece (e.g., monolithic).

[0387] In some examples, tire device is biocompatible.

[0388] In some examples, the device further comprises a therapeutic agent dispersed within at least a portion of the device. In some examples, the therapeutic agent is dispersed substantially homogeneously throughout the device. In some examples, the therapeutic agent is dispersed inhomogeneously throughout the device (e.g., randomly, along a concentration gradient, only in certain portions, etc.).

[0389] The therapeutic agent can, for example, comprise an anticancer agent, anti-inflammatory agent, analgesic agent, antimicrobial agent, or a combination thereof. As used herein, antimicrobials include, for example, antibacterials, antifungals, and antivirals.

[0390] In some examples, the therapeutic agent can comprise an anticancer agent. In some examples, the therapeutic agent comprises a chemotherapeutic agent, an immunotherapeutic agent, or a combination thereof.

[0391] In some examples, the therapeutic agent can comprise a chemotherapeutic agent.

[0392] In some examples, the therapeutic agent can comprise an anti-inflammatory agent, such as steroidal and / or non-steroidal anti-inflammatory agents.

[0393] In some examples, the therapeutic agent can comprise an analgesic.

[0394] In some examples, the therapeutic agent can comprise an analgesic, such as an opioid. In some examples, the device is configured to be stable for an amount of time after the device is implanted in the subject. As used herein, “stable” means that 10 wt% or less (e.g., 9% or less, 8% or less, 7% or less, 6% or less, 5% or less, 4% or less, 3% or less, 2% or less, or 1 % or less) of the device biodegrades over the selected time period after the device is implanted in the subject.

[0395] In some examples, the device is configured to biodegrade over an amount of time after the device is implanted in the subject.

[0396] In some examples, the device is anatomically designed for the subject. In some examples, the device is implantable in the subject.

[0397] In some examples, the device is configured to conforms to anatomical contours, ensuring uniform tension distribution and long-term ptosis prevention.

[0398] In some examples, the plurality of radial fenestrations are staggered.

[0399] In some examples, the plurality of radial fenestrations are configured to balance adaptability with material integrity, focusing on areas requiring maximum projection.

[0400] In some examples, the device comprises the device of any one of Figure 1 - Figure 15. In some examples, the device has a surface area which can be selected in view of the anatomical location and dimensions thereof. For example, the surface area of the device can be selected based on the surface area of the anatomical location where the device is to be inserted. For example, the device and the anatomical location can each have an average lateral dimension, and the average lateral dimension of the device can be selected to be comparable to the average lateral dimension of the anatomical location where the device is to be inserted.

[0401] When the device is used to support at least a portion of a breast or breast implant, the surface area of the device can be selected in view of the surface area of said portion of the breast or breast implant. For example, if the surface area of the device is too large relative to the portion of the breast or breast implant, the device will be too loose and can lead to undesirable rippling. Alternatively, if the surface area of the device is, for example, too small relative to the portion of the breast or breast implant, the device will be too tight, which can lead to undesirable effects.

[0402] Also disclosed herein are kits comprising any of the devices disclosed herein disposed within a sterile package. In some examples, the kit further comprises a pre-marking template, a stapling device, or a combination thereof.

[0403] Also disclosed herein are methods of making any of the devices disclosed herein.

[0404] In some examples, the method comprises introducing the plurality of radial fenestrations in the biocompatible material.

[0405] In some examples, the method comprises forming the upper and / or lower edge of the device.

[0406] In some examples, the method comprises forming the notches and / or tabs.

[0407] In some examples, the method comprises making the device based on an anatomical image of a subject. In some examples, the method further comprises collecting the anatomical image of the subject.

[0408] In some examples, the method further comprises anatomically designing the device for the subject. Also disclosed herein are methods of use of any of the devices disclosed herein.

[0409] In some examples, the method is a method of treating a subject in need thereof. In some examples, the method comprises implanting any of the devices disclosed herein into the subject.

[0410] In some examples, the device is implanted into at least a portion of a breast of the subject.

[0411] In some examples, the method comprises breast reconstruction, augmentation (e.g., full or partial breast reconstruction or augmentation), and / or cosmetic improvement such as after a lumpectomy or mastectomy.

[0412] In some examples, the method comprises one stage or two stage implant based breast reconstruction.

[0413] In some examples, the method further comprises anatomically designing the device for the subject.

[0414] In some examples, the device is secured after implantation, for example using sutures, staples, etc.

[0415] In some examples, the method further comprises anatomically designing the device for the subject.

[0416] In some examples, the methods can comprise breast reconstruction (e.g., full or partial breast reconstruction) and treatment of an oncological disorder, such as breast cancer. In some examples, the devices can further include a therapeutic agent, for example for treatment of the oncological disorder.

[0417] For the treatment of oncological disorders, the devices disclosed herein can be administered to a patient in need of treatment in combination with other antitumor or anti-cancer substances and / or with radiation and / or photodynamic therapy and / or with surgical treatment to remove a tumor. These other substances or treatments can be given at the same as or at different times from the devices disclosed herein.

[0418] EXEMPLARY ASPECTS

[0419] In view of the described compositions, devices, systems, and methods, herein below are described certain more particularly described aspects of the inventions. The particularly recited aspects should not, however, be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein or that the “particular” aspects are somehow limited in some way other than the inherent meanings of the language and formulas literally used therein.

[0420] Example 1: A device configured to be inserted into an anatomical location of a subject, the device comprising: a biocompatible material having an upper edge, a lower edge, a folding edge, and a thickness; one or more notches in the lower edge, such that the device further comprises a plurality of tabs along the lower edge; wherein the tabs are configured to be folded or tucked in along the folding edge after insertion at the anatomical location; and one or more slits, each of the slits perforating the thickness of the biocompatible material, wherein the slits are located proximate the folding edge, opposite the tabs, such that after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, and the slits allow for access to the tabs through the device.

[0421] Example 2: The device of any example herein, particularly example 1, wherein the device includes 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, or 10 or more notches.

[0422] Example 3: The device of any example herein, particularly example 1 or example 2, wherein the device includes 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 11 or more tabs.

[0423] Example 4: The device of any example herein, particularly examples 1-3, wherein the device includes 3 notches and 4 tabs.

[0424] Example 5: The device of any example herein, particularly examples 1-4, wherein the notches and tabs are configured to provide dual functionality for orientation and anchoring.

[0425] Example 6: The device of any example herein, particularly examples 1-5, wherein the number, location, size, and / or shape of the notches are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0426] Example 7: The device of any example herein, particularly examples 1-6, wherein the notches are configured such that the tabs do not overlap when tucked in to conform to the 3D curvature / projection of the anatomical location.

[0427] Example 8: The device of any example herein, particularly examples 1-7, wherein the number, location, size, and / or shape of the tabs are selected in view' of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0428] Example 9: The device of any example herein, particularly examples 1-8, wherein the tabs are configured such that they do not overlap when tucked in to conform to the 3D curvature / projection of the breast.

[0429] Example 10: The device of any example herein, particularly examples 1-9, wherein the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ), for example to accommodate a sufficient number of sutures, anchors, staples, etc. to securely attach the device in the subject after insertion at the anatomical location. Example 11: The device of any example herein, particularly examples 1-10, wherein the device includes 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, 11 or more, 12 or more, 13 or more, 14 or more, or 15 or more slits.

[0430] Example 12: The device of any example herein, particularly examples 1-11, wherein the slits are oriented along the folding edge.

[0431] Example 13: The device of any example herein, particularly examples 1-12, wherein the number, location, size, and / or shape of the slits are selected in view of the size of the tabs.

[0432] Example 14: The device of any example herein, particularly examples 1-13, wherein the slits allow freedom of access to the tabs after the tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

[0433] Example 15: The device of any example herein, particularly examples 1-14, wherein each of the slits has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material.

[0434] Example 16: The device of any example herein, particularly examples 1-15, wherein each of the tabs can further comprise one or more perforations that perforates the thickness of the biocompatible material.

[0435] Example 17: The device of any example herein, particularly example 16, wherein the one or more perforations on the tabs is oriented such that they align with a slit after tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

[0436] Example 18: The device of any example herein, particularly example 16 or example 17, wherein, after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, the slits allow for access to the tabs through the device, and the perforations allow for access to the subject through the tabs for anchoring the device to the subject.

[0437] Example 19: The device of any example herein, particularly examples 1-18, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape

[0438] Example 20: The device of any example herein, particularly examples 1-19, wherein the device further comprises a plurality of fenestrations, each of the plurality of fenestrations perforating the thickness of the biocompatible material: wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject;

[0439] Example 21: The device of any example herein, particularly examples 1-20, wherein the device provides enhanced support at the anatomical location. Example 22: A device configured to be inserted into an anatomical location of a subject, the device comprising: a biocompatible material having an upper edge, a lower edge, and a thickness, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape; and a plurality of fenestrations, each of the plurality of fenestrations perforating the thickness of the biocompatible material; wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject; wherein the device provides enhanced support at the anatomical location.

[0440] Example 23: The device of any example herein, particularly examples 20-22, wherein the number, location, size, and / or shape of the fenestrations are selected in view the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0441] Example 24: The device of any example herein, particularly examples 20-23, wherein the fenestrations are arranged radially.

[0442] Example 25: A device configured to be inserted into an anatomical location of a subject, the device comprising: a biocompatible material having an upper edge, a lower edge, and a thickness, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape; and a plurality of radial fenestrations, each of the plurality of radial fenestrations perforating the thickness of the biocompatible material; wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject; wherein the device provides enhanced support at the anatomical location.

[0443] Example 26: The device of any example herein, particularly example 25, wherein the number, location, size, and / or shape of the radial fenestrations are selected in view the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0444] Example 27: The device of any example herein, particularly examples 20-26, wherein at least a portion of the plurality of the fenestrations (e.g., the plurality of radial fenestrations) are located towards the upper edge of the device where the most expansion is desired.

[0445] Example 28: The device of any example herein, particularly examples 20-27, wherein the fenestrations (e.g., the radial fenestrations) are staggered to allow maximum opening without weakening the device.

[0446] Example 29: The device of any example herein, particularly examples 20-28, wherein each of the fenestrations (e.g., each of the radial fenestrations) has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material. Example 30: The device of any example herein, particularly examples 22-29, wherein the device further comprises one or more notches (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, or 10 or more) in the lower edge, such that the device further comprises a plurality of tabs (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 11 or more) along the lower edge.

[0447] Example 31: The device of any example herein, particularly example 30, wherein the device includes 3 notches and 4 tabs.

[0448] Example 32: The device of any example herein, particularly example 30 or example 31, wherein the notches and tabs are configured to provide dual functionality for orientation and anchoring.

[0449] Example 33: The device of any example herein, particularly examples 30-32, wherein the number, location, size, and / or shape of the notches are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0450] Example 34: The device of any example herein, particularly examples 30-33, wherein the notches are configured such that the tabs do not overlap when tucked in to conform to the 3D curvature / projection of the anatomical location.

[0451] Example 35: The device of any example herein, particularly examples 30-34, wherein the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0452] Example 36: The device of any example herein, particularly examples 30-35, wherein the tabs are configured such that they do not overlap when tucked in to conform to the 3D curvature / projection of the breast.

[0453] Example 37: The device of any example herein, particularly examples 30-36, wherein the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ), for example to accommodate a sufficient number of sutures, anchors, staples, etc. to securely attach the device in the subject after insertion at the anatomical location.

[0454] Example 38: The device of any example herein, particularly examples 30-37, wherein the device further comprises a folding edge, wherein the tabs can be folded or tucked in along the folding edge after insertion at the anatomical location.

[0455] Example 39: The device of any example herein, particularly examples 22-38, wherein the device further comprises one or more slits (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, 11 or more, 12 or more, 13 or more, 14 or more, or 15 or more), each of the slits perforating the thickness of the biocompatible material. Example 40: The device of any example herein, particularly example 39, wherein the slits are located proximate the folding edge, opposite the tabs.

[0456] Example 41: The device of any example herein, particularly example 39 or example 40, wherein the slits are oriented along the folding edge.

[0457] Example 42: The device of any example herein, particularly examples 39-41, wherein the number, location, size, and / or shape of the slits can be selected in view of the size of the tabs.

[0458] Example 43: The device of any example herein, particularly examples 39-42, wherein the slits allow freedom of access to the tabs after the tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

[0459] Example 44: The device of any example herein, particularly examples 39-43, wherein, after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, and the slits allow for access to the tabs through the device.

[0460] Example 45: The device of any example herein, particularly examples 39-44, wherein each of the slits has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material.

[0461] Example 46: The device of any example herein, particularly examples 39-45, wherein each of the tabs can further comprise one or more perforations that perforates the thickness of the biocompatible material, and wherein the one or more perforations on the tabs is oriented such that they align with a slit after tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

[0462] Example 47: The device of any example herein, particularly example 46, wherein, after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, the slits allow for access to the tabs through the device, and the perforations allow for access to the subject through the tabs for anchoring the device to the subject.

[0463] Example 48: The device of any example herein, particularly examples 1-47, wherein the device is symmetrical.

[0464] Example 49: The device of any example herein, particularly examples 1-48, wherein the device is configured to be elastic along a direction (e.g., horizontally), but have minimal elasticity perpendicular to said direction (e.g., vertically).

[0465] Example 50: The device of any example herein, particularly examples 1-49, wherein the biocompatible material comprises ADM, a bioresorbable polymer, a composite material, a synthetic material, or a combination thereof. Example 51: The device of any example herein, particularly examples 1-50, wherein the biocompatible material comprises a polymer such as a bioresorbable polymer, collagen, or a combination thereof.

[0466] Example 52: The device of any example herein, particularly examples 1-51, wherein the biocompatible material comprises a synthetic material, such as a synthetic mesh.

[0467] Example 53: The device of any example herein, particularly examples 1-52, wherein the biocompatible material comprises a shape-memory material.

[0468] Example 54: The device of any example herein, particularly examples 1-53, wherein the biocompatible material comprises a biological matrix.

[0469] Example 55: The device of any example herein, particularly example 54, wherein the biological matrix is derived from human dermis, animal dermis, or animal material.

[0470] Example 56: The device of any example herein, particularly example 54 or example 55, wherein the biological matrix comprises FlexHD pliable ADM, FlexHD pliable MAX ADM, AlloDerm®, DermACELL (e.g., DermACELL AWM®, etc.), porcine ADM, STRATTICE®, CORTIVA™ (e.g., CORTIVA™ allograft dermis), ALLOMAX™, SurgiMend®, ARTIA™, XenMatrix™, Permacol™, Tutopatch™, or a combination thereof.

[0471] Example 57: The device of any example herein, particularly examples 1-56, wherein the biocompatible material comprises vicryl mesh, gortex, poly(4-Hydroxybuterate) (e.g., Galaflex), Polydioxanone (PDO) (e.g., Durasorb), polyglycolic acid trimethylene carbonate (PGA- PMC) (e.g., TIGR matrix), silk (e.g., SERI scaffold), polypropylene and / or polyglycolic acid (e.g., OviTex®), ULTRAPRO™ mesh, PROCEED™ mesh, Phasix™ mesh, or a combination thereof.

[0472] Example 58: The device of any example herein, particularly examples 1-57, wherein the device is reversible (e.g., posterior and anterior surfaces are substantially the same).

[0473] Example 59: The device of any example herein, particularly examples 1-57, wherein the device has a posterior surface and an anterior surface, the posterior surface and the anterior surface being different.

[0474] Example 60: The device of any example herein, particularly examples 1-59, wherein the device is configured to support and / or reshape at least a portion of an organ and / or at least a portion of an implant when inserted into the anatomical location of the subject.

[0475] Example 61: The device of any example herein, particularly examples 1-60, wherein the device has a two dimensional shape that can stretch to a three dimensional shape that conforms to support and / or reshape an organ and / or an implant when inserted into the anatomical location of the subject. Example 62: The device of any example herein, particularly examples 1-61, wherein the anatomical location comprises a breast, a buttock, abdominal wall, or pelvic floor of the subject.

[0476] Example 63: The device of any example herein, particularly examples 1-62, wherein the anatomical location comprises a breast of the subject.

[0477] Example 64: The device of any example herein, particularly example 63, wherein the device is configured to support at least a portion of a breast or at least a portion of a breast implant.

[0478] Example 65: The device of any example herein, particularly example 63 or example 64, wherein the device is for facilitating reconstruction, augmentation, and / or cosmetic improvement of a breast, the breast having an upper pole, a lower pole, a most projecting portion, and an inframammary fold, wherein the device is configured to support and / or reshape at least a portion of the lower pole.

[0479] Example 66: The device of any example herein, particularly example 65, wherein the device is configured to be positioned such that the upper edge is positioned towards the most projecting portion and extending inferiorly to the lower edge positioned towards the inframammary fold.

[0480] Example 67: The device of any example herein, particularly examples 63-66, wherein the device is configured to be utilized with a breast implant.

[0481] Example 68: The device of any example herein, particularly example 67, wherein the device is configured to cover a portion of the breast implant.

[0482] Example 69: The device of any example herein, particularly examples 67-68, wherein, in use, the device is positioned prepectorally or postpectorally, anterior to the breast implant.

[0483] Example 70: The device of any example herein, particularly examples 67-69, wherein the size and / or shape of the device is selected based on the volume and / or shape of the breast implant.

[0484] Example 71: The device of any example herein, particularly examples 67-70, wherein the breast implant has an intra-operative fill volume of from 0 cubic centimeters (cc) to 1500 cc.

[0485] Example 72: The device of any example herein, particularly examples 1-71, wherein the device is a single piece (e.g., monolithic).

[0486] Example 73: The device of any example herein, particularly examples 1-72, wherein the device is biocompatible.

[0487] Example 74: The device of any example herein, particularly examples 1-73, wherein the device further comprises a therapeutic agent dispersed within at least a portion of the device. Example 75: The device of any example herein, particularly example 74, wherein the therapeutic agent is dispersed substantially homogeneously throughout the device.

[0488] Example 76: The device of any example herein, particularly example 74 or example 75, wherein the therapeutic agent comprises an anticancer agent, anti-inflammatory agent, analgesic agent, antimicrobial agent, a growth factor, an anti -fibrotic agent, or a combination thereof.

[0489] Example 77: The device of any example herein, particularly examples 74-76, the therapeutic agent comprises a chemotherapeutic agent, an immunotherapeutic agent, or a combination thereof.

[0490] Example 78: The device of any example herein, particularly examples 1-77, wherein the device is configured to be stable for an amount of time after the device is implanted in the subject.

[0491] Example 79: The device of any example herein, particularly examples 1-78, wherein the device is configured to biodegrade over an amount of time after the device is implanted in the subject.

[0492] Example 80: The device of any example herein, particularly examples 1-79, wherein the device is anatomically designed for the subject.

[0493] Example 81: The device of any example herein, particularly examples 1-80, wherein the device is implantable in the subject.

[0494] Example 82: The device of any example herein, particularly examples 1-81, wherein the device is configured to conforms to anatomical contours, ensuring uniform tension distribution and long-term ptosis prevention.

[0495] Example 83: The device of any example herein, particularly examples 20-82, wherein the plurality of fenestrations are configured to balance adaptability with material integrity, focusing on areas requiring maximum projection.

[0496] Example 84: The device of any example herein, particularly examples 1-83, wherein the device comprises the device of any one of Figure 1 - Figure 31.

[0497] Example 85: A kit comprising the device of any example herein, particularly examples 1- 84 disposed within a sterile package.

[0498] Example 86: The kit of any example herein, particularly example 85, wherein the kit further comprises a pre-marking template, a stapling device, or a combination thereof.

[0499] Example 87: A method of making the device of any example herein, particularly examples 1-84.

[0500] Example 88: The method of any example herein, particularly example 87, wherein the method comprises: introducing the plurality of fenestrations in the biocompatible material; forming the upper and / or lower edge of the device; forming the notches and / or tabs; forming the slits; or a combination thereof.

[0501] Example 89: The method of any example herein, particularly examples 87-88, wherein the method comprises making the device based on an anatomical image of a subject.

[0502] Example 90: The method of any example herein, particularly example 89, wherein the method further comprises collecting the anatomical image of the subject.

[0503] Example 91: The method of any example herein, particularly examples 89-90, wherein the method further comprises anatomically designing the device for the subject.

[0504] Example 92: A method of use of the device of any example herein, particularly examples 1-84.

[0505] Example 93: The method of any example herein, particularly example 92, wherein the method is a method of treating a subject in need thereof, the method comprising implanting the device of any example herein, particularly examples 1-84 into the subject.

[0506] Example 94: The method of any example herein, particularly example 93, wherein the device is implanted into at least a portion of a breast of the subject.

[0507] Example 95: The method of any example herein, particularly example 94, wherein the method comprises breast reconstruction, augmentation (e.g., full or partial breast reconstruction or augmentation), and / or cosmetic improvement such as after a lumpectomy or mastectomy.

[0508] Example 96: The method of any example herein, particularly example 94 or example 95, wherein the method comprises one stage or two stage implant based breast reconstruction.

[0509] Example 97: The method of any example herein, particularly examples 92-96, wherein the method further comprises anatomically designing the device for the subject.

[0510] Example 98: The method of any example herein, particularly examples 92-97, wherein the device is secured after implantation, for example using sutures, staples, etc.

[0511] Example Al: A device as described herein.

[0512] Example A2: The device of any examples herein, particularly example Al, including each and every novel feature or combinations of features disclosed herein.

[0513] Example A3: The device of any examples herein, particularly examples A1-A2, wherein the device is configured to be inserted into an anatomical location of a subject, the device comprising: a biocompatible material having an upper edge, a lower edge, and a thickness, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape; and a plurality of radial fenestrations, each of the plurality of radial fenestrations perforating the thickness of the biocompatible material; wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject; wherein the device provides enhanced support at the anatomical location.

[0514] Example A4: The device of any examples herein, particularly examples Al -A3, wherein the device is symmetrical.

[0515] Example A5: The device of any examples herein, particularly examples A1-A4, wherein the device is configured to be elastic along a direction (e.g. horizontally ), but have minimal elasticity perpendicular to said direction (e.g. vertically).

[0516] Example A6: The device of any examples herein, particularly examples A1-A5, wherein at least a portion of the plurality of the radial fenestrations are located towards the upper edge of the device where the most expansion is desired.

[0517] Example A7: The device of any examples herein, particularly examples A1-A6, wherein the radial fenestrations are staggered to allow maximum opening without weakening the device.

[0518] Example A8: The device of any examples herein, particularly examples A1-A7, wherein the number, location, size, and / or shape of the radial fenestrations are selected in view the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0519] Example A9: The device of any examples herein, particularly examples A1-A8, wherein the device further comprises one or more notches (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, or 7 or more) in the lower edge, such that the device further comprises a plurality of tabs (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, or 8 or more) along the lower edge.

[0520] Example A 10: The device of any examples herein, particularly example A9, wherein the device includes 3 notches and 4 tabs.

[0521] Example Al l: The device of any examples herein, particularly example A9 or example A10, wherein the notches and tabs are configured to provide dual functionality for orientation and anchoring.

[0522] Example Al 2: The device of any examples herein, particularly examples A9-A11, wherein the number, location, size, and / or shape of the notches are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

[0523] Example A13: The device of any examples herein, particularly examples A9-A12, wherein the notches are configured such that the tabs do not overlap when tucked in to conform to the 3D curvature / proj ection of the anatomical location.

[0524] Example Al 4: The device of any examples herein, particularly examples A9-A13, wherein the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control. Example A 15: The device of any examples herein, particularly examples A9-A14, wherein the tabs are configured such that they do not overlap when tucked in to conform to the 3D curvature / projection of the breast.

[0525] Example A16: The device of any examples herein, particularly examples A9-A15, wherein the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ), for example to accommodate a sufficient number of sutures, anchors, staples, etc. to securely attach the device in the subject after insertion at the anatomical location.

[0526] Example A17: The device of any examples herein, particularly examples A1-A16, wherein the biocompatible material comprises ADM, a bioresorbable polymer, a composite material, or a combination thereof.

[0527] Example Al 8: The device of any examples herein, particularly examples A1-A17, wherein the biocompatible material comprises a polymer such as a bioresorbable polymer, collagen, or a combination thereof.

[0528] Example A19: The device of any examples herein, particularly examples A1-A18, wherein the biocompatible material comprises a shape-memory material.

[0529] Example A20: The device of any examples herein, particularly examples A1-A19, wherein the biocompatible material comprises a biological matrix.

[0530] Example A21: 'The device of any examples herein, particularly example A20, wherein the biological matrix is derived from human dermis, animal dermis, or animal material.

[0531] Example A22: The device of any examples herein, particularly example A20 or example A21, wherein the biological matrix comprises FlexHD pliable ADM, FlexHD pliable MAX ADM, AlloDerm®, DermACELL (e.g., DermACELL AWM®, etc.), porcine ADM, STRATTICE®, CORTIVA™ (e.g., CORTIVA™ allograft dermis), ALLOMAX™, SurgiMend®, ARTIA™, or a combination thereof.

[0532] Example A23: The device of any examples herein, particularly examples A1-A22, wherein the biocompatible material comprises vicryl mesh, gortex, poly(4-Hydroxybuterate) (e.g., Galaflex), Polydioxanone (PDO) (e.g., Durasorb), polygiycolic acid trimethylene carbonate (PGA- PMC) (e.g., TIGR matrix), silk (e.g., SERI scaffold), polypropylene and / or polygiycolic acid (e.g., OviTex®), or a combination thereof.

[0533] Example A24: The device of any examples herein, particularly examples A1-A23, wherein the device is reversible (e.g., posterior and anterior surfaces are substantially the same). Example A25: The device of any examples herein, particularly examples A1-A23, wherein the device has a posterior surface and an anterior surface, the posterior surface and the anterior surface being different.

[0534] Example A26: The device of any examples herein, particularly examples A1-A25, wherein the device is configured to support and / or reshape at least a portion of an organ and / or at least a portion of an implant when inserted into the anatomical location of the subject.

[0535] Example A27: The device of any examples herein, particularly examples A1-A26, wherein the device has a two dimensional shape that can stretch to a three dimensional shape that conforms to support and / or reshape an organ and / or an implant when inserted into the anatomical location of the subject.

[0536] Example A28: The device of any examples herein, particularly examples A1-A27, wherein the anatomical location comprises a breast, a buttock, abdominal wall, or pelvic floor of the subject.

[0537] Example A29: The device of any examples herein, particularly examples A1-A28, wherein the anatomical location comprises a breast of the subject.

[0538] Example A30: The device of any examples herein, particularly example A29, wherein the device is configured to support at least a portion of a breast or at least a portion of a breast implant.

[0539] Example A31: 'The device of any examples herein, particularly example A29 or example A30, wherein the device is for facilitating reconstruction, augmentation, and / or cosmetic improvement of a breast, the breast having an upper pole, a lower pole, a most projecting portion, and an inframammary fold, wherein the device is configured to support and / or reshape at least a portion of the lower pole.

[0540] Example A32: The device of any examples herein, particularly example A31, wherein the device is configured to be positioned such that the upper edge is positioned towards the most projecting portion and extending inferiorly to the lower edge positioned towards the inframammary fold.

[0541] Example A33: The device of any examples herein, particularly examples A29-A32, wherein the device is configured to be utilized with a breast implant.

[0542] Example A34: The device of any examples herein, particularly example A33, wherein the device is configured to cover a portion of the breast implant.

[0543] Example A35: The device of any examples herein, particularly examples A33-A34, wherein, in use, the device is positioned prepectorally or postpectorally, anterior to the breast implant. Example A36: The device of any examples herein, particularly examples A33-A35, wherein the size and / or shape of the device is selected based on the volume and / or shape of the breast implant.

[0544] Example A37: The device of any examples herein, particularly examples A33-A36, wherein the breast implant has an intra-operative fill volume of from 0 cubic centimeters (cc) to 1500 cc.

[0545] Example A38: The device of any examples herein, particularly examples A1-A37, wherein the device is a single piece (e.g., monolithic).

[0546] Example A39: The device of any examples herein, particularly examples A1-A38, wherein the device is biocompatible.

[0547] Example A40: The device of any examples herein, particularly examples A1-A39, wherein the device further comprises a therapeutic agent dispersed within at least a portion of the device.

[0548] Example A41: The device of any examples herein, particularly example A40, wherein the therapeutic agent is dispersed substantially homogeneously throughout the device.

[0549] Example A42: The device of any examples herein, particularly example A40 or example A41, wherein the therapeutic agent comprises an anticancer agent, anti-inflammatory agent, analgesic agent, antimicrobial agent, or a combination thereof.

[0550] Example A43: The device of any examples herein, particularly examples A40-A42, the therapeutic agent comprises a chemotherapeutic agent, an immunotherapeutic agent, or a combination thereof.

[0551] Example A44: The device of any examples herein, particularly examples A1-A43, wherein device is configured to be stable for an amount of time after the device is implanted in the subject.

[0552] Example A45: The device of any examples herein, particularly examples A1-A44, wherein the device is configured to biodegrade over an amount of time after the device is implanted in the subject.

[0553] Example A46: The device of any examples herein, particularly examples A1-A45, wherein the device is anatomically designed for the subject.

[0554] Example A47: The device of any examples herein, particularly examples A1-A46, wherein the device is implantable in the subject.

[0555] Example A48: The device of any examples herein, particularly examples A1-A47, wherein the device is configured to conforms to anatomical contours, ensuring uniform tension distribution and long-term ptosis prevention. Example A49: The device of any examples herein, particularly examples A1-A48, wherein the plurality of radial fenestrations are staggered.

[0556] Example A50: The device of any examples herein, particularly examples A1-A49, wherein the plurality of radial fenestrations are configured to balance adaptability with material integrity, focusing on areas requiring maximum projection.

[0557] Example A51: The device of any examples herein, particularly examples A1-A50, wherein the device comprises the device of any one of Figure 1 - Figure 15.

[0558] Example A52: A kit comprising the device of any examples herein, particularly examples A1-A51 disposed within a sterile package.

[0559] Example A53: The kit of any examples herein, particularly example A52, wherein the kit further comprises a pre-marking template, a stapling device, or a combination thereof.

[0560] Example A54: A method of making the device of any examples herein, particularly examples A1-A51.

[0561] Example A55: The method of any examples herein, particularly example A54, including each and every novel feature of combinations of features disclosed herein.

[0562] Example A56: The method of any examples herein, particularly example A54 or example A55, wherein the method comprises making the device based on an anatomical image of a subject.

[0563] Example A57: The method of any examples herein, particularly example A56, wherein the method further comprises collecting the anatomical image of the subject.

[0564] Example A58: The method of any examples herein, particularly examples A54-A57, wherein the method further comprises anatomically designing the device for the subject.

[0565] Example A59: A method of use of the device of any examples herein, particularly examples A1-A51.

[0566] Example A60: The method of any examples herein, particularly example A59, including each and every novel feature of combinations of features disclosed herein.

[0567] Example A61: The method of any examples herein, particularly example A59 or example A60, wherein the method is a method of treating a subject in need thereof, the method comprising implanting the device of any examples herein, particularly examples A1-A51 into the subject.

[0568] Example A62: The method of any examples herein, particularly example A61, wherein the device is implanted into at least a portion of a breast of the subject.

[0569] Example A63: The method of any examples herein, particularly example A62, wherein the method comprises breast reconstruction, augmentation (e.g., full or partial breast reconstruction or augmentation), and / or cosmetic improvement such as after a lumpectomy or mastectomy.

[0570] Example A64: The method of any examples herein, particularly example A62 or example A63, wherein the method comprises one stage or two stage implant based breast reconstruction.

[0571] Example A65: The method of any examples herein, particularly examples A59-A64, wherein the method further comprises anatomically designing the device for the subject.

[0572] Example A66: The method of any examples herein, particularly examples A59-A65, wherein the device is secured after implantation, for example using sutures, staples, etc.

[0573] Example A67: The method of any examples herein, particularly examples A59-A66, wherein the method further comprises anatomically designing the device for the subject.

[0574] Other advantages which are obvious and which are inherent to the invention will be evident to one skilled in the art. It will be understood that certain features and sub-combinations are of utility and may be employed without reference to other features and sub-combinations. This is contemplated by and is within the scope of the claims. Since many possible embodiments may be made of the invention without departing from the scope thereof, it is to be understood that all matter herein set forth or shown in the accompanying drawings is to be interpreted as illustrative and not in a limiting sense.

[0575] The methods of the appended claims are not limited in scope by the specific methods described herein, which are intended as illustrations of a few aspects of the claims and any methods that are functionally equivalent are intended to fall within the scope of the claims. Various modifications of the methods in addition to those shown and described herein are intended to fall within the scope of the appended claims. Further, while only certain representative method steps disclosed herein are specifically described, other combinations of the method steps also are intended to fall within the scope of the appended claims, even if not specifically recited. Thus, a combination of steps, elements, components, or constituents may be explicitly mentioned herein or less, however, other combinations of steps, elements, components, and constituents are included, even though not explicitly stated.

Claims

CLAIMSWhat is claimed is:

1. A device configured to be inserted into an anatomical location of a subject, the device comprising:a biocompatible material having an upper edge, a lower edge, a folding edge, and a thickness;one or more notches in the lower edge, such that the device further comprises a plurality of tabs along the lower edge;wherein the tabs are configured to be folded or tucked in along the folding edge after insertion at the anatomical location; andone or more slits, each of the slits perforating the thickness of the biocompatible material, wherein the slits are located proximate the folding edge, opposite the tabs, such that after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, and the slits allow for access to the tabs through the device.

2. The device of claim 1, wherein the device includes 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, or 10 or more notches.

3. The device of claim 1 or claim 2, wherein the device includes 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 11 or more tabs.

4. The device of any one of claims 1-3, wherein the device includes 3 notches and 4 tabs.

5. The device of any one of claims 1-4, wherein the notches and tabs are configured to provide dual functionality for orientation and anchoring.

6. The device of any one of claims 1-5, wherein the number, location, size, and / or shape of the notches are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

7. The device of any one of claims 1-6, wherein the notches are configured such that the tabs do not overlap when tucked in to conform to the 3D curvature / projection of the anatomical location.

8. The device of any one of claims 1-7, wherein the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

9. The device of any one of claims 1 -8, wherein the tabs are configured such that they do not overlap when tucked in to conform to the 3D curvature / projection of the breast.

10. The device of any one of claims 1-9, wherein the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ), for example to accommodate a sufficient number of sutures, anchors, staples, etc. to securely attach the device in the subject after insertion at the anatomical location.

11. The device of any one of claims 1-10, wherein the device includes 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, 11 or more, 12 or more, 13 or more, 14 or more, or 15 or more slits.

12. The device of any one of claims 1-11, wherein the slits are oriented along the folding edge.

13. The device of any one of claims 1-12, wherein the number, location, size, and / or shape of the slits are selected in view' of the size of the tabs.

14. The device of any one of claims 1-13, wherein the slits allow freedom of access to the tabs after the tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

15. The device of any one of claims 1-14, wherein each of the slits has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material.

16. The device of any one of claims 1-15, wherein each of the tabs can further comprise one or more perforations that perforates the thickness of the biocompatible material.

17. The device of claim 16, wherein the one or more perforations on the tabs is oriented such that they align with a slit after tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

18. The device of claim 16 or claim 17, wherein, after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, the slits allow for access to the tabs through the device, and the perforations allow for access to the subject through the tabs for anchoring the device to the subject.

19. The device of any one of claims 1-18, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape20. The device of any one of claims 1-19, wherein the device further comprises a plurality of fenestrations, each of the plurality of fenestrations perforating the thickness of the biocompatible material; wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject;21. The device of any one of claims 1-20, wherein the device provides enhanced support at the anatomical location.

22. A device configured to be inserted into an anatomical location of a subject, the device comprising:a biocompatible material having an upper edge, a lower edge, and a thickness, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape; anda plurality of fenestrations, each of the plurality of fenestrations perforating the thickness of the biocompatible material;wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject;wherein the device provides enhanced support at the anatomical location.

23. The device of any one of claims 20-22, wherein the number, location, size, and / or shape of the fenestrations are selected in view the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

24. The device of any one of claims 20-23, wherein the fenestrations are arranged radially.

25. A device configured to be inserted into an anatomical location of a subject, the device comprising:a biocompatible material having an upper edge, a lower edge, and a thickness, wherein at least a portion of the upper edge and at least a portion of the lower edge are curved such that the device has an arc shape; anda plurality of radial fenestrations, each of the plurality of radial fenestrations perforating the thickness of the biocompatible material;wherein the plurality of fenestrations are configured to allow the device to adapt to the three dimensional shape of the anatomical location of the subject;wherein the device provides enhanced support at the anatomical location.

26. The device of claim 25, wherein the number, location, size, and / or shape of the radial fenestrations are selected in view the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

27. The device of any one of claims 20-26, wherein at least a portion of the plurality of the fenestrations (e.g., the plurality of radial fenestrations) are located towards the upper edge of the device where the most expansion is desired.

28. The device of any one of claims 20-27, wherein the fenestrations (e.g., the radial fenestrations) are staggered to allow maximum opening without weakening the device.

29. The device of any one of claims 20-28, wherein each of the fenestrations (e.g., each of the radial fenestrations) has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material.

30. The device of any one of claims 22-29, wherein the device further comprises one or more notches (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, or 10 or more) in the lower edge, such that the device further comprises a plurality of tabs (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 11 or more) along the lower edge.

31. The device of claim 30, wherein the device includes 3 notches and 4 tabs.

32. The device of claim 30 or claim 31, wherein the notches and tabs are configured to provide dual functionality for orientation and anchoring.

33. The device of any one of claims 30-32, wherein the number, location, size, and / or shape of the notches are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

34. The device of any one of claims 30-33, wherein the notches are configured such that the tabs do not overlap when tucked in to conform to the 3D curvature / projection of the anatomical location.

35. The device of any one of claims 30-34, wherein the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ) and / or the desired shape control.

36. The device of any one of claims 30-35, wherein the tabs are configured such that they do not overlap when tucked in to conform to the 3D curvature / projection of the breast.

37. The device of any one of claims 30-36, wherein the number, location, size, and / or shape of the tabs are selected in view of the size of device (e.g., the size of an underlying implant or organ), for example to accommodate a sufficient number of sutures, anchors, staples, etc. to securely attach the device in the subject after insertion at the anatomical location.

38. The device of any one of claims 30-37, wherein the device further comprises a folding edge, wherein the tabs can be folded or tucked in along the folding edge after insertion at the anatomical location.

39. The device of any one of claims 22-38, wherein the device further comprises one or more slits (e.g., 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, 11 or more, 12 or more, 13 or more, 14 or more, or 15 or more), each of the slits perforating the thickness of the biocompatible material.

40. The device of claim 39, wherein the slits are located proximate the folding edge, opposite the tabs.

41. The device of claim 39 or claim 40, wherein the slits are oriented along the folding edge.

42. The device of any one of claims 39-41, wherein the number, location, size, and / or shape of the slits can be selected in view of the size of the tabs.

43. The device of any one of claims 39-42, wherein the slits allow freedom of access to the tabs after the tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

44. The device of any one of claims 39-43, wherein, after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, and the slits allow for access to the tabs through the device.

45. The device of any one of claims 39-44, wherein each of the slits has a periphery and at least a portion of the periphery is reinforced or sealed to prevent fraying of the biocompatible material.

46. The device of any one of claims 39-45, wherein each of the tabs can further comprise one or more perforations that perforates the thickness of the biocompatible material, and wherein the one or more perforations on the tabs is oriented such that they align with a slit after tabs have been tucked in, for example to allow for easier attachment of the device in the subject after insertion at the anatomical location.

47. The device of claim 46, wherein, after tucking in or folding back the tabs, the tabs are located posterior to the rest of the device, the slits allow for access to the tabs through the device, and the perforations allow for access to the subject through the tabs for anchoring the device to the subject.

48. The device of any one of claims 1-47, wherein the device is symmetrical.

49. The device of any one of claims 1 -48, wherein the device is configured to be elastic along a direction (e.g., horizontally), but have minimal elasticity perpendicular to said direction (e.g., vertically).

50. The device of any one of claims 1-49, wherein the biocompatible material comprises ADM, a bioresorbable polymer, a composite material, a synthetic material, or a combination thereof.

51. The device of any one of claims 1-50, wherein the biocompatible material comprises a polymer such as a bioresorbable polymer, collagen, or a combination thereof.

52. The device of any one of claims 1-51, wherein the biocompatible material comprises a synthetic material, such as a synthetic mesh.

53. The device of any one of claims 1-52, wherein the biocompatible material comprises a shape-memory material.

54. The device of any one of claims 1-53, wherein the biocompatible material comprises a biological matrix.

55. The device of claim 54, wherein the biological matrix is derived from human dermis, animal dermis, or animal material.

56. The device of claim 54 or claim 55, wherein the biological matrix comprises FlexHD pliable ADM, FlexHD pliable MAX ADM, AlloDerm®, DermACELL (e.g., DermACELL AWM®, etc.), porcine ADM, STRAITICE®, CORTIVA™ (e.g., CORTIVA™ allograft dermis), ALLOMAX™, SurgiMend®, ARTIA™, XenMatrix™, Permacol™, Tutopatch™, or a combination thereof.

57. The device of any one of claims 1-56, wherein the biocompatible material comprises vicryl mesh, gortex, poly(4-Hydroxybuterate) (e.g., Galaflex), Polydioxanone (PDO) (e.g., Durasorb), polyglycolic acid trimethylene carbonate (PGA- PMC) (e.g., IIGR matrix), silk (e.g., SERI scaffold), polypropylene and / or polyglycolic acid (e.g., OviTex®), ULTRAPRO™ mesh, PROCEED™ mesh, Phasix™ mesh, or a combination thereof.

58. The device of any one of claims 1-57, wherein the device is reversible (e.g., posterior and anterior surfaces are substantially the same).

59. The device of any one of claims 1 -57, wherein the device has a posterior surface and an anterior surface, the posterior surface and the anterior surface being different.

60. The device of any one of claims 1-59, wherein the device is configured to support and / or reshape at least a portion of an organ and / or at least a portion of an implant when inserted into the anatomical location of the subject.

61. The device of any one of claims 1-60, wherein the device has a two dimensional shape that can stretch to a three dimensional shape that conforms to support and / or reshape an organ and / or an implant when inserted into the anatomical location of the subject.

62. The device of any one of claims 1-61, wherein the anatomical location comprises a breast, a buttock, abdominal wall, or pelvic floor of the subject.

63. The device of any one of claims 1-62, wherein the anatomical location comprises a breast of the subject.

64. The device of claim 63, wherein the device is configured to support at least a portion of a breast or at least a portion of a breast implant.

65. The device of claim 63 or claim 64, wherein the device is for facilitating reconstruction, augmentation, and / or cosmetic improvement of a breast, the breast having an upper pole, a lower pole, a most projecting portion, and an inframammary fold, wherein the device is configured to support and / or reshape at least a portion of the lower pole.

66. The device of claim 65, wherein the device is configured to be positioned such that the upper edge is positioned towards the most projecting portion and extending inferiorly to the lower edge positioned towards the inframammary fold.

67. The device of any one of claims 63-66, wherein the device is configured to be utilized with a breast implant.

68. The device of claim 67, wherein the device is configured to cover a portion of the breast implant.

69. The device of any one of claims 67-68, wherein, in use, the device is positioned prepectorally or postpectorally, anterior to the breast implant.

70. The device of any one of claims 67-69, wherein the size and / or shape of the device is selected based on the volume and / or shape of the breast implant.

71. The device of any one of claims 67-70, wherein the breast implant has an intra-operative fill volume of from 0 cubic centimeters (cc) to 1500 cc.

72. The device of any one of claims 1-71, wherein the device is a single piece (e.g., monolithic).

73. The device of any one of claims 1-72, wherein the device is biocompatible.

74. The device of any one of claims 1-73, wherein the device further comprises a therapeutic agent dispersed within at least a portion of the device.

75. The device of claim 74, wherein the therapeutic agent is dispersed substantially homogeneously throughout the device.6 / 76. The device of claim 74 or claim 75, wherein the therapeutic agent comprises an anticancer agent, anti-inflammatory agent, analgesic agent, antimicrobial agent, a growth factor, an anti-fibrotic agent, or a combination thereof.

77. The device of any one of claims 74-76, the therapeutic agent comprises a chemotherapeutic agent, an immunotherapeutic agent, or a combination thereof.

78. The device of any one of claims 1-77, wherein the device is configured to be stable for an amount of time after the device is implanted in the subject.

79. The device of any one of claims 1-78, wherein the device is configured to biodegrade over an amount of time after the device is implanted in the subject.

80. The device of any one of claims 1-79, wherein the device is anatomically designed for the subject.

81. The device of any one of claims 1-80, wherein the device is implantable in the subject.

82. The device of any one of claims 1-81, wherein the device is configured to conforms to anatomical contours, ensuring uniform tension distribution and long-term ptosis prevention.

83. The device of any one of claims 20-82, wherein the plurality of fenestrations are configured to balance adaptability with material integrity, focusing on areas requiring maximum projection.

84. The device of any one of claims 1-83, wherein the device comprises the device of any one of Figure 1 - Figure 31.

85. A kit comprising the device of any one of claims 1-84 disposed within a sterile package.

86. The kit of claim 85, wherein the kit further comprises a pre-marking template, a stapling device, or a combination thereof.

87. A method of making the device of any one of claims 1-84.

88. The method of claim 87, wherein the method comprises: introducing the plurality of fenestrations in the biocompatible material; forming the upper and / or lower edge of the device; forming the notches and / or tabs; forming the slits; or a combination thereof.

89. The method of any one of claims 87-88, wherein the method comprises making the device based on an anatomical image of a subject.

90. The method of claim 89, wherein the method further comprises collecting the anatomical image of the subject,91. The method of any one of claims 89-90, wherein the method further comprises anatomically designing the device for the subject,92. A method of use of the device of any one of claims 1-84.

93. The method of claim 92, wherein the method is a method of treating a subject in need thereof, the method comprising implanting the device of any one of claims 1-84 into the subject.

94. The method of claim 93, wherein the device is implanted into at least a portion of a breast of the subject.

95. The method of claim 94, wherein the method comprises breast reconstruction, augmentation (e.g., full or partial breast reconstruction or augmentation), and / or cosmetic improvement such as after a lumpectomy or mastectomy.

96. The method of claim 94 or claim 95, wherein the method comprises one stage or two stage implant based breast reconstruction.

97. The method of any one of claims 92-96, wherein the method further comprises anatomically designing the device for the subject.

98. The method of any one of claims 92-97, wherein the device is secured after implantation, for example using sutures, staples, etc.

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