Implantable devices and related methods

Abstract

An implantable device includes a pocket portion and a funnel portion. The pocket portion defines a pocket sized and shaped to receive an implantable prosthetic. The pocket portion is configured to be inserted within a body of a subject. The funnel portion is attached to and extends from the pocket portion. The funnel portion defines a channel, and is configured to permit passage of the implantable prosthetic through the channel and into the pocket while the pocket portion is within the body of the subject. At least part of the funnel portion is configured to be removed from the implantable device while the pocket portion is within the body of the subject.

Description

Docket No. D0188.70528WO00- 1 -IMPLANTABLE DEVICES AND RELATED METHODSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application 63 / 697,908, filed on September 23, 2024, the content of which is incorporated herein by reference in its entirety.FIELD

[0002] Disclosed embodiments are related to implantable devices and related methods.BACKGROUND

[0003] Breast reconstruction following mastectomy has become an integral and important part of breast cancer treatment with the surgery providing the patient with both aesthetic and psychosocial benefits. Many breast reconstruction procedures use a tissue expander to create a pocket for a permanent breast implant in the first step of the procedure (although for some patients, a pocket for the breast implant can be formed without the use of a tissue expander). Once a breast pocket has been created, the tissue expander is removed, and replaced with a permanent breast implant in a second step.

[0004] Breast implants can also be used in breast augmentation and mastopexy procedures. In the latter procedure, a breast lift is combined with breast augmentation. Most commonly, the breast implant is placed in a pocket under the breast tissue, but in some cases, it is implanted under the chest wall. In some instances, breast implants are used in breast revision procedures, in which existing implants are swapped out for new implants. Revision procedures may take place if the existing implant was poorly positioned during the initial placement procedure, and / or if any long-term complications arise following implantation.

[0005] Breast implants differ in dimensions, shape, and surface texture. A wide variety of different dimensions are available allowing the surgeon and patient to select from a range of sizes and overall volume. In terms of shape, there are round and anatomically shaped implants, and the surfaces of the implants may be smooth, micro-textured or macro-textured.12845258.1WGS Ref. No.: D0188.70528WQ00- 2 -Generally, round implants have smooth surfaces, whereas anatomically shaped implants have dimpled micro- or macro-textured surfaces.SUMMARY

[0006] In some embodiments, an implantable device may include a pocket portion and a funnel portion. The pocket portion may define a pocket sized and shaped to receive an implantable prosthetic. The pocket portion may further be configured to be inserted within a body of a subject. The funnel portion may be attached to and may extend from the pocket portion. The funnel portion may further define a channel, and may be configured to permit passage of the implantable prosthetic through the channel and into the pocket while the pocket portion is within the body of the subject. In some embodiments, at least part of the funnel portion may be configured to be removed from the implantable device while the pocket portion is within the body of the subject.

[0007] In further embodiments, a method of using an implantable device may include inserting a pocket portion of the implantable device into a pocket formed in a body of a subject. The method may further include inserting an implantable prosthetic into a funnel portion of the implantable device. In some embodiments, the funnel portion may be attached to and extending from the pocket portion. Further, in some embodiments, the funnel portion may extend out from the pocket formed in the body of the subject. In some embodiments, the method may further include passing the implantable prosthetic through the funnel portion and into the pocket portion. The method may additionally include removing at least a part of the funnel portion from the implantable device.

[0008] In some embodiments, an implantable device may include a pocket portion defining a pocket. The pocket may be sized and shaped to receive an implantable prosthetic. The pocket portion may include a distal end portion including an opening configured to permit passage of the implantable prosthetic into the pocket. The pocket portion may further be configured to be inserted within a body of a subject. In some embodiments, the implantable device may further include at least one tether passing through the pocket portion at a plurality of locations disposed within at least one compressive zone of the pocket portion. Each compressive zone of the at least one compressive zone may extend around at least a portion of an outer perimeter of the pocket portion from the distal end portion to a proximal12845258.1WGS Ref. No.: D0188.70528WQ00- 3 - end portion opposite the distal end portion, and may have a width extending inwardly from the outer perimeter of the pocket portion. The at least one tether may be configured to constrict the at least one compressive zone around the implantable prosthetic by reducing the width of the at least one compressive zone in response to tension applied to the at least one tether.

[0009] In additional embodiments, a method of using an implantable device may include inserting an implantable prosthetic into a pocket portion of the implantable device. The pocket portion may comprise a distal end portion including an opening configured to permit passage of the implantable prosthetic into the pocket. The method may further include applying tension to at least one tether of the implantable device to constrict at least one compressive zone of the pocket portion around the implantable prosthetic. Each compressive zone of the at least one compressive zone may extend around at least a portion of an outer perimeter of the pocket portion from the distal end portion to a proximal end portion opposite the distal end portion, and may have a width extending inwardly from the outer perimeter of the pocket portion. In some embodiments, applying tension to the at least one tether may reduce the width of the at least one compressive zone.

[0010] In further embodiments, an implantable device may include a pocket portion defining a pocket. The pocket may be sized and shaped to receive an implantable prosthetic. The pocket portion may comprise a distal end portion including an opening configured to permit passage of the implantable prosthetic into the pocket. The pocket portion may be configured to be inserted within a body of a subject. The implantable device may further include a tether passing through a proximal end portion of the pocket portion opposite the distal end portion. The tether may be configured to facilitate positioning of the implantable device within the body of the subject along a longitudinal axis of the subject.

[0011] In still further embodiments, a method of using an implantable device may include inserting a tether of the implantable device into a body of a subject, and inserting a pocket portion of the implantable device into the body of the subject. The tether may pass through a proximal end portion of the pocket portion opposite a distal end portion. The distal end portion may include an opening configured to permit passage of an implantable prosthetic into the pocket portion. The method may further include applying tension to the tether to position the pocket portion along a longitudinal axis of the subject.12845258.1WGS Ref. No.: D0188.70528WQ00- 4 -

[0012] It should be appreciated that the foregoing concepts, and additional concepts discussed below, may be arranged in any suitable combination, as the present disclosure is not limited in this respect. Further, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various nonlimiting embodiments when considered in conjunction with the accompanying figures.

[0013] In the event the present specification and a document incorporated by reference include conflicting and / or inconsistent disclosure, the present specification shall control. If two or more documents incorporated by reference include conflicting and / or inconsistent disclosure with respect to each other, then the document having the later effective date shall control.BRIEF DESCRIPTION OF DRAWINGS

[0014] In the drawings, each identical or nearly identical component that is illustrated in various figures may be represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:

[0015] Fig. 1 depicts an implantable device having a funnel portion according to some embodiments;

[0016] Figs. 2A-2D depict operation of an implantable device according to some embodiments;

[0017] Figs. 3A-3D depict insertion into a subject of an implantable device according to some embodiments;

[0018] Figs. 4A-4C depict insertion into a subject of an implantable device according to some embodiments;

[0019] Figa. 5A-5B depict an implantable device having compressive zones, according to some embodiments;

[0020] Fig. 6 depicts an implantable device having a clamshell construction, according to some embodiments;

[0021] Figs. 7A-7B depict an implantable device having compressive zones, according to some embodiments;12845258.1WGS Ref. No.: D0188.70528WQ00- 5 -

[0022] Figs. 8A-8B depict an implantable device having compressive zones, according to some embodiments; and

[0023] Fig. 9 depicts a method of using an implantable device, according to some embodiments.DETAILED DESCRIPTION

[0024] Some breast implantation procedures may utilize a funnel to facilitate insertion of an implant into a breast pocket, for example by inserting a narrow end of the funnel into an incision (e.g., an inframammary incision) and guiding the implant along the funnel, through the incision, and into the breast pocket. In some instances, such a funnel may beneficially allow the size of the incision to be reduced in comparison to similar procedures which do not utilize a funnel. The implant may be guided along the funnel by pushing or squeezing the implant, with the implant’s plasticity or elasticity allowing it to be forced through a progressively smaller channel in the funnel while retaining the ability to recover its original shape once implanted into the breast pocket.

[0025] Some implantation procedures may additionally or alternatively utilize an implantable device within the breast pocket to facilitate proper placement and / or support of the implant. In some instances, an implant may be covered with or inserted into an implant wrap prior to implantation, for example to prevent the implant from migrating and / or rotating within the breast pocket, or to support the implant. However, such a wrap may be formed from materials which may alter a mechanical property of the implant. For example, a wrap may be formed from a mesh, a prosthetic fabric, or another material which may limit the effective plasticity or elasticity of the wrapped implant, thereby rendering the wrapped implant more rigid and / or less pliable. The Inventors have recognized that, although wrapping an implant may beneficially facilitate positioning and / or support of the implant, a wrapped implant may be difficult to utilize in conjunction with a funnel because the mechanical properties (e.g., stiffness) of the wrapped implant may render it difficult to push or squeeze through the funnel.

[0026] In view of the above, the inventors have recognized and appreciated the benefits of an implantable device which may be secured in place at a desired position within the breast pocket, and / or which includes a funnel to guide insertion of the implant into the12845258.1WGS Ref. No.: D0188.70528WQ00- 6 - breast pocket. In some embodiments, an implantable device may include a pocket portion and a funnel portion. The pocket portion may be configured to be placed within the breast pocket, and may be configured to receive an implant before or after placement within the breast pocket. In some embodiments, the pocket portion may include an opening configured to receive the implant therethrough. The funnel portion may extend from the pocket portion, and may be integrated with or attached to the pocket portion. For example, in some embodiments, the funnel portion and the pocket portion may be formed of a continuous material (e.g., a mesh, a prosthetic fabric material, or any other material as described herein). Further, in some embodiments, the funnel portion may be configured to extend at least partially out of the breast pocket when the pocket portion has been inserted into the breast pocket. For example, the funnel portion may be sized and shaped to extend out from an inframammary incision when the pocket portion is disposed in the breast pocket. In some embodiments, at least part of the funnel portion may be configured to be folded around and / or underneath the pocket portion. For example, in some embodiments, the funnel portion (or a portion thereof) may be configured to be folded around and / or underneath the pocket portion in order to close the opening of the pocket portion and / or to fully enclose the implantable prosthetic within the pocket portion. In some embodiments, at least part of the funnel portion may be removable from the pocket portion when the funnel is no longer needed (i.e., after the implant has been inserted into the breast pocket). For example, in some embodiments, the funnel portion or part of the funnel portion may be configured to be removed from the pocket portion by cutting, tearing, electrocautery, or otherwise separating the funnel portion. In some such embodiments, a stub portion of the funnel portion may remain attached to the funnel portion after the removable portion has been removed. The stub portion may be configured to be configured to be folded around and / or underneath the pocket portion (e.g., to close the opening of the pocket portion as discussed above).

[0027] As noted above, in many procedures, the implantable prosthetic and / or implantable device may be inserted into the breast pocket through an inframammary incision. In some procedures, it may be desirable to minimize the size of the inframammary incision, for example to minimize the size of a resulting scar, or simply to avoid further trauma to the subject than is needed. However, the inframammary incision may also be the primary or exclusive point of access by which a surgeon can enter or operate within the breast pocket,12845258.1WGS Ref. No.: D0188.70528WQ00- 7 - for example to place or adjust positioning of the implantable prosthetic and / or implantable device within the breast pocket. In other words, an inframammary incision that is too small may impede the surgeon’s ability to control or adjust a position of the prosthetic / device within the breast pocket when using conventional implantation procedures.

[0028] In some applications, a longitudinal positioning of the prosthetic / device (i.e., a position of the prosthetic / device along the subject’s craniocaudal or anatomical longitudinal axis) may influence a shape or other aesthetic quality of the resulting breast. For example, it may be desirable to recreate an anatomically natural teardrop shape to the breast by securing the prosthetic at a superior position along the longitudinal axis (i.e., on the superior side of the breast pocket, nearer to the subject’s head). However, such superior securement may be difficult to achieve because the inframammary incision is placed along an inferior side of the breast pocket (e.g., along the inframammary fold line). Thus, access to the superior side may be challenging, particularly after a prosthetic and / or implantable device has been inserted into the breast pocket.

[0029] In view of the above, the Inventors have recognized and appreciated the benefits of an implantable device which facilitates positioning and / or securing the device on a superior side of the breast pocket. In some embodiments, a tether may be inserted into or through the implantable device or a portion thereof, and may facilitate positioning and / or securement of the device on the superior side of the breast pocket. For example, a tether may be inserted through or coupled to a proximal end portion of the device or a pocket portion thereof. The tether may be configured to be inserted into / through tissue forming or surrounding the superior side of the breast pocket (e.g., tissue of the chest wall, subpectoral muscle, and / or others) to form a pulley or an anchor point within the tissue. The tether may include one or more terminal ends configured to extend in an inferior direction (e.g., towards or out of the inframammary incision). Tensioning the terminal end(s) may pull or otherwise move the proximal end portion of the implantable device (or pocket portion thereof) along the longitudinal axis in a superior direction and / or into the superior side of the breast pocket.

[0030] Limited access to the breast pocket may lead to additional challenges during a procedure, particularly after the implantable prosthetic and device have been inserted into the breast pocket. In some embodiments, one function of an implantable device may be to support the prosthetic or provide a desired shape to the prosthetic. In some embodiments, the12845258.1WGS Ref. No.: D0188.70528WQ00- 8 - implantable device may additionally or alternatively facilitate proper ingrowth of tissue around the implant. In some cases, these and other functions of the implantable device may be influenced by how closely or tightly the implant is held within the device. For example, a large gap between the material of the implantable device and the prosthetic itself may inhibit the implantable device’s ability to support or impart a desired shape to the prosthetic, and / or may not facilitate tissue ingrowth as well as a device with a smaller gap or with no gap. However, because access to the breast pocket may be limited as discussed above, it may be difficult to adjust the tightness of the device around the prosthetic after insertion.

[0031] In view of the above, the inventors have recognized and appreciated the benefits of an implantable device which facilitates enclosing or cinching the device around the prosthetic after insertion. In some embodiments, an implantable device or a portion thereof (e.g., a pocket portion) may include a compressive zone which may be configured to be constricted or closed around an implantable prosthetic or a portion of the prosthetic. For example, in some embodiments, a tether may be inserted into or through the compressive zone in such a way that tensioning the tether may cause the compressive zone to be compressed around the prosthetic. For example, in some embodiments, the tether may pass through the material of the pocket portion at a plurality of locations within the compressive zone, such that tensioning the tether draws at least some of the locations closer together, thereby reducing at least one dimension of the compressive zone.

[0032] In some embodiments, a compressive zone may extend between a distal end portion and a proximal end portion of the pocket portion and may comprise a width extending inwardly from an outer perimeter of the pocket portion. Additionally, in some embodiments, a compressive zone may further comprise a height extending between a front face of the pocket portion and a rear face of the pocket portion. In some embodiments, a terminal end of the tether may be configured to extend towards and / or out of the inframammary incision after the device has been inserted into the breast pocket, such that the compressive zone may be compressed around the prosthetic by applying tension to (e.g., pulling on) the terminal end to tension the tether. Further, in some embodiments, an implantable device or pocket portion thereof may include more than one compressive zone. For example, a first compressive zone may extend around a first portion of a perimeter of the pocket portion, and a second compressive zone may extend around a second portion of the perimeter. In some such12845258.1WGS Ref. No.: D0188.70528WQ00- 9 - embodiments, the first and second portions of the perimeter may be on opposing sides of the pocket portion. Further, in some embodiments, the first and second compressive zones may be spaced apart, for example by a distance and / or a sweep angle around the perimeter. In some embodiments, a living hinge may be disposed between the first and second compressive zones at the proximal end portion of the pocket portion. Additionally or alternatively, in some embodiments, the opening of the pocket portion may be disposed between the first and second compressive zones at the distal end portion of the pocket portion. Thus, in some embodiments, the first and second compressive zones may be spaced apart at the distal end portion, the proximal end portion, or both the distal and proximal end portions.

[0033] In some embodiments, the plurality of locations through which the tether passes in the compressive zone may be selected to arrange the tether in a substantially periodic pattern. As will be described further below, the periodic pattern may have any appropriate parameter, including any appropriate distance between consecutive peaks, troughs, or locations, or any other appropriate parameter. For example, in some embodiments, the plurality of locations may be selected to arrange the tether in a pattern in which a distance between two consecutive peaks or troughs of the pattern is greater than or equal to 1 mm, greater than or equal to 2 mm, greater than or equal to 4 mm, or any other appropriate distance. Additionally or alternatively, the distance between two consecutive peaks or troughs may be less than or equal to 4 mm, less than or equal to 6 mm, less than or equal to 8 mm, or any other appropriate distance. Combinations of the foregoing are also contemplated, including greater than or equal to 1 mm and less than or equal to 8 mm, greater than or equal to 4 mm and less than or equal to 6 mm, and / or any other appropriate distance or combination of distances.

[0034] Further, in some embodiments, a compressive zone may have any appropriate height as disclosed herein. For example, in some embodiments, the height of a compressive zone may be greater than or equal to 0.5 cm, greater than or equal to 1 cm, greater than or equal to 2 cm, greater than or equal to 4 cm, or any other appropriate distance. Additionally or alternatively, the height of a compressive zone may be less than or equal to 3 cm, less than or equal to 5 cm, less than or equal to 7 cm, or any other appropriate distance. Combinations of the foregoing are also contemplated, including greater than or equal to 0.5 cm and less than12845258.1WGS Ref. No.: D0188.70528WQ00- 10 - or equal to 7 cm, greater than or equal to 1 cm and less than or equal to 3 cm, and / or any other appropriate height or combination of heights.

[0035] Further, in some embodiments, the width of the compressive zone may extend any appropriate distance inwardly from the outer perimeter of the pocket portion. For example, in some embodiments, the width of the compressive zone may extend inwardly from the outer perimeter by at least about 3 mm, at least about 5 mm, at least about 7 mm, or at least about 10 mm.

[0036] In some embodiments, various dimensions of an implantable device may be selected based on the dimensions of a corresponding implantable prosthetic. Furthermore, in some embodiments, various dimensions of an implantable device may be selected to facilitate a no-contact implantation procedure to avoid contact with, and thus potential contamination of, the implant or the implantable device. In a no-contact procedure, direct contact between a source of potential contamination (e.g., a hand, a glove, an incision or an exposed area of the subject’s body such as the subject’s skin, and / or other sources of potential contamination) and the implant or the implantable device may be avoided or inhibited. For example, in some embodiments, a dimension of a funnel portion of an implantable device may be selected to provide enough excess material around the prosthetic that an operator may squeeze the prosthetic along the funnel portion without contacting the prosthetic, but rather by contacting only the excess material of the funnel portion surrounding and extending beyond a position of the prosthetic within the funnel portion. For example, a length of a funnel portion (i.e., a distance between a distal opening and a proximal opening of the funnel portion) and / or a width of the funnel portion may be selected based on a length and / or width of the implantable prosthetic. Additionally or alternatively, in some embodiments, the material of the funnel portion or other portion of the implantable device may be configured to prevent contaminants from passing through the material. In some embodiments, the length of the funnel portion may be selected such that the implantable prosthetic may be inserted into the funnel portion (i.e., through the distal opening) to a depth that may permit the funnel portion to fully enclose the implantable prosthetic.

[0037] In some embodiments, a funnel portion may have any appropriate length. For example, in some embodiments, a funnel portion may have a length greater than or equal to 15 cm, greater than or equal to 20 cm, greater than or equal to 25 cm, or any other appropriate12845258.1WGS Ref. No.: D0188.70528WQ00- 11 - length. Additionally or alternatively, in some embodiments, a funnel portion may have a length less than or equal to 25 cm, less than or equal to 35 cm, less than or equal to 50 cm, or any other appropriate length. Combinations of the foregoing are also contemplated, including greater than or equal to 15 cm and less than or equal to 50 cm, greater than or equal to 20 cm and less than or equal to 35 cm, or any other appropriate length or combination of lengths.

[0038] In some embodiments, a distal opening of a funnel portion may have any appropriate width. For example, in some embodiments, a distal opening of a funnel portion may have a width greater than or equal to 5 cm, greater than or equal to 10 cm, greater than or equal to 35 cm, or any other appropriate width. Additionally or alternatively, in some embodiments, a distal opening of a funnel portion may have a width less than or equal to 15 cm, less than or equal to 25 cm, less than or equal to 45 cm, or any other appropriate width. Combinations of the foregoing are also contemplated, including greater than or equal to 5 cm and less than or equal to 45 cm, greater than or equal to 10 cm and less than or equal to 25 cm, or any other appropriate width or combination of widths.

[0039] In some embodiments, a proximal opening of a funnel portion and / or an opening at a distal end portion of a pocket portion may have any appropriate width. For example, in some embodiments, a proximal opening of a funnel portion and / or an opening at a distal end portion of a pocket portion may have a width greater than or equal to 2.5 cm, greater than or equal to 5 cm, greater than or equal to 10 cm, greater than or equal to 12.5 cm, greater than or equal to 15 cm, or any other appropriate width. Additionally or alternatively, in some embodiments, a proximal opening of a funnel portion and / or an opening at a distal end portion of a pocket portion may have a width less than or equal to 10 cm, less than or equal to 15 cm, less than or equal to 17.5 cm, less than or equal to 20 cm, or any other appropriate width. Combinations of the foregoing are also contemplated, including greater than or equal to 2.5 cm and less than or equal to 20 cm, greater than or equal to 5 cm and less than or equal to 10 cm, greater than or equal to 12.5 cm and less than or equal to 17.5 cm, or any other appropriate width or combination of widths.

[0040] Further, in some embodiments, the width of a funnel portion may taper from a first smaller width at the proximal end portion adjacent to the pocket portion to a second greater width at a distal end portion. For example, in some embodiments, the width of the funnel portion may taper at a taper angle as described herein. In embodiments, a taper angle12845258.1WGS Ref. No.: D0188.70528WQ00- 12 - of the funnel portion may be any appropriate angle. For example, in some embodiments, a taper angle of the funnel portion may be greater than or equal to 5 degrees, greater than or equal to 10 degrees, greater than or equal to 15 degrees, greater than or equal to 20 degrees, or any other appropriate angle. Additionally or alternatively, in some embodiments, a taper angle of the funnel portion may be less than or equal to 10 degrees, less than or equal to 20 degrees, less than or equal to 30 degrees, or less than or equal to 45 degrees. Combinations of the foregoing are also contemplated, including greater than or equal to 5 degrees and less than or equal to 45 degrees, greater than or equal to 10 degrees and less than or equal to 15 degrees, or any other appropriate angle or combination of angles.

[0041] Similarly, in some embodiments, various dimensions of the pocket portion may be selected based on a size of the implantable prosthetic. For example, a width of the pocket portion may be selected based, at least in part, on a width of the implantable prosthetic (e.g., to prevent or reduce wrinkling, folding, separation from the prosthetic, and / or other deformations in the material of the implantable device which may result from excess material). In some embodiments, the width of the pocket portion may greater than or equal to 5 cm, greater than or equal to 8 cm, greater than or equal to 10 cm, or any other appropriate width. Additionally or alternatively, in some embodiments, the width of the pocket portion may be less than or equal to 10 cm, less than or equal to 20 cm, less than or equal to 30 cm, or any other appropriate width. Combinations of the foregoing are also contemplated, including greater than or equal to 5 cm and less than or equal to 30 cm, greater than or equal to 8 cm and less than or equal to 20 cm, or any other appropriate width or combination of widths.

[0042] In some embodiments, the implantable device or a portion thereof (e.g., the pocket portion and / or the funnel portion), may be provided in a substantially two-dimensional form. For example, the implantable device may lie flat within a plane when disposed on a flat supporting surface without a prosthetic disposed therein in some embodiments.

[0043] In some embodiments, the implantable device or a portion thereof may be provided in a substantially three-dimensional form. For example, the pocket and / or funnel portions may be pre-formed, for example to mimic or complement the curvature of the breast implant (and / or any other suitable implant) and may be sized and shaped to receive the12845258.1WGS Ref. No.: D0188.70528WQ00- 13 - implant therein. In some embodiments, the pocket portion may have a hemispherical shape to conform to a breast implant to reduce the likelihood of wrinkles and warpage.

[0044] In some embodiments, the implantable devices of the present disclosure may be formed of a biocompatible prosthetic repair fabric, such as a porous mesh material. The pores of the mesh may induce tissue infiltration and growth of natural tissue around the implant. In some embodiments, the implantable device may be formed of a bio-absorbable material which may degrade while natural tissue is growing throughout the pores. In this way, the implantable device may be slowly replaced by native tissue. In other embodiments, the implantable device may be formed of a permanent material and may exhibit porosity and / or texture to induce tissue growth on its surface.

[0045] In some embodiments, an implantable device or a portion thereof (e.g., the pocket portion and / or the funnel portion) may be formed from a sheet of repair fabric through any suitable means, including, but not limited to by die cutting, laser cutting, waterjets, handcutting, and / or any other suitable formation technique. In embodiments where portions of the implantable device are pre-formed in a three-dimensional shape, the repair fabric sheet may be formed using a thermal or compressive molding technique, as will be described in detail below.

[0046] Although described in the context of breast implants for illustrative purposes, the disclosed implantable devices may be used for a number of different applications, and may offer many different benefits. The implantable devices may be formed of a porous material to serve as a scaffold for tissue infiltration where tissue may grow into the implantable device in some embodiments. The native tissue may serve as a natural shell around the implant and reduce the risks of capsular contracture and potential rejections of the foreign implant. In this regard, complication risks may be reduced and surgical outcomes may be improved. Tissue in-growth may have an added benefit of resistance to migration, as the native tissue formed through the pores of the implantable device may be grown from and / or fixed to the native anatomical space. The formation of native tissue formed at the implant site may further reduce the risk of foreign body reaction complications, such as capsular contracture. In some embodiments, the implantable devices may surround the implant and may be affixed to the surgical site in a manner that reduces the contact between the implant and the incision site through which the implant is delivered. For example, the12845258.1WGS Ref. No.: D0188.70528WQ00- 14 - implantable device may shield the implant from viscera or fluids at the incision site for reduced risks of necrosis and contamination.

[0047] The implantable devices of the present disclosure may be formed of a biocompatible material which may promote rapid tissue or muscle in-growth into and around the implantable device. In some embodiments, the implantable devices may be formed of an absorbable material that may be replaced in vivo by the patient’s natural tissue as the implantable device degrades.

[0048] In some embodiments, the implantable device may be formed of an absorbable material (e.g., polymer or copolymer) that may be substantially resorbed after implantation within a timeframe of about 1 to 24 months timeframe, about 3 to 18 months, and / or any other suitable timeframe. In some embodiments, the implantable device may retain some residual strength for at least 2 weeks to 6 months, at least 12 weeks to 6 months, and / or any other suitable timeframe. It should be appreciated that the implantable devices of the present disclosure may retain residual strength through any suitable timeframe, depending on the operation and implant site.

[0049] In some embodiments, the implantable device may include an absorbable polymer comprising, or prepared from, one or more monomers selected from the group: glycolide, lactide, glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3- hydroxybutyric acid, 3 -hydroxybutyrate, 4-hydroxybutyric acid, 4-hydroxybutyrate, 8- caprolactone, 1,4-butanediol, 1,3 -propane diol, ethylene glycol, glutaric acid, malic acid, malonic acid, oxalic acid, succinic acid, and adipic acid.

[0050] In some embodiments, the implantable devices may be formed of poly-4- hydroxybutyrate (P4HB) and copolymers thereof, or poly(butylene succinate) (PBS) and copolymers thereof. In embodiments, the P4HB and PBS polymers, and copolymers thereof, may not be crosslinked. In embodiments, the PBS polymer and copolymers may further include one or more of the following: branching agent, cross-linking agent, chain extender agent, and reactive blending agent. The PBS and P4HB polymers and copolymers may be isotopically enriched in some embodiments.

[0051] The implantable devices of the present disclosure may be formed of a repair fabric material in the form of a mesh, a woven material, a nonwoven material, a knitted material, a braided material, a felted fabric, combinations thereof, and / or any other suitable12845258.1WGS Ref. No.: D0188.70528WQ00- 15 - types of repair fabric. In some embodiments, the repair fabric material may be porous to allow native biological material (e.g., fluids, cells, vasculature) to infiltrate the implantable device. The repair fabric material may be formed of nonlimiting exemplary materials such as PHASIX mesh available from Davol, GalaFLEX or GalaFLEX LITE available from Galatea, TIGR Matrix available from Novus Scientific, SERI Surgical Body available from Allergen, BIO-A available from Gore, and ULTRAPRO available from Ethicon. If desired, a nonwoven material may be employed as an alternative or together with a mesh to provide a relatively softer profile for the prosthesis.

[0052] In some embodiments, the polymers used to prepare the implantable devices may have weight average molecular weights of 50 to 1,000 kDa, 90 to 600 kDa, and / or from 200 to 450 kDa relative to polystyrene determined by GPC, although other weight average molecular weight polymers are contemplated.

[0053] In some embodiments, the implantable device may be formed of permanent materials, such as non-biodegradable thermoplastic polymers, including polymers and copolymers of ethylene and propylene, including ultra-high molecular weight polyethylene, ultra-high molecular weight polypropylene, nylon, polyesters such as poly(ethylene terephthalate), poly(tetrafluoroethylene), polyurethanes, poly (ether- urethanes), poly(methylmethacrylate), polyether ether ketone, polyolefins, and poly(ethylene oxide). In other embodiments, implantable device may be formed of degradable materials, including but not limited to, thermoplastic or polymeric degradable materials. Combinations of the foregoing are contemplated. In some embodiments, the implantable device may be formed of one or more absorbable polymers or copolymers, absorbable thermoplastic polymers and copolymers, and / or absorbable thermoplastic polyesters. The implantable device may be formed of polymers including, but not limited to, polymers of glycolic acid, lactic acid, 1,4- dioxanone, trimethylene carbonate, 3 -hydroxy butyric acid, 4- hydroxybutyrate, e- caprolactone, including polyglycolic acid, polylactic acid, polydioxanone, polycaprolactone, copolymers of glycolic and lactic acids, such as VICRYL® polymer, MAXON® and MONOCR YL® polymers, and including poly(lactide-co-caprolactones); poly(orthoesters); poly anhydrides; poly(phosphazenes); polyhydroxyalkanoates; synthetically or biologically prepared polyesters; polycarbonates; tyrosine polycarbonates; polyamides (including synthetic and natural polyamides, polypeptides, and poly(amino acids)); polyesteramides;12845258.1WGS Ref. No.: D0188.70528WQ00- 16 - poly (alky lene alkylates); polyethers (such as polyethylene glycol, PEG, and polyethylene oxide, PEO); polyvinyl pyrrolidones or PVP; polyurethanes; polyetheresters; polyacetals; polycyanoacrylates; poly(oxyethylene) / poly(oxypropylene) copolymers; polyacetals, polyketals; polyphosphates; (phosphorous -containing) polymers; polyphosphoesters; polyalkylene oxalates; polyalkylene succinates; poly (maleic acids); silk (including recombinant silks and silk derivatives and analogs); chitin; chitosan; modified chitosan; biocompatible polysaccharides; hydrophilic or water soluble polymers, such as polyethylene glycol, (PEG) or polyvinyl pyrrolidone (PVP), with blocks of other biocompatible or biodegradable polymers, for example, poly(lactide), poly(lactide-co-glycolide, or polycaprolactone and copolymers thereof, including random copolymers and block copolymers thereof.

[0054] In some embodiments, an implantable device may be loaded, filled, and / or coated with an appropriate therapeutic composition. This may include coatings, absorbed materials retained in the implantable device, adsorbed materials, compounds functionally bonded to the material of the implantable device, and / or any other appropriate way of associating a therapeutic composition with the implantable device. Appropriate types of therapeutic compositions may include, but are not limited to, cells, stem cells, differentiated cells, fat cells, muscle cells, platelets, pedicles, vascular pedicles, tissue masses, extracellular adipose matrix proteins, gels, hydrogels, hyaluronic acid, collagen, bioactive agents, drugs, antibiotics, and other appropriate therapeutic compositions that may be desirable to deliver to the implant site. The cells and tissues, which may be delivered and / or coated or injected into the implantable device, may be autologous. The implantable device may be used for autologous fat transfer. The cells added, coated or injected on the implantable device may include pancreatic islet cells, hepatic cells, and stem cells genetically altered to contain genes for treatment of patient illnesses. The implantable device may include bioactive agents to stimulate cell in-growth, including growth factors, cell adhesion factors, cellular differentiating factors, cellular recruiting factors, cell receptors, cell-binding factors, cell signaling molecules, such as cytokines, and molecules to promote cell migration, cell division, cell proliferation and extracellular matrix deposition. The implantable devices may also be partially or entirely coated and / or contain agents to prevent tissue adhesion, or agents to prevent cell proliferation, particularly to delay cell invasion into the implantable devices.12845258.1WGS Ref. No.: D0188.70528WQ00- 17 -

[0055] In some embodiments, the implantable devices may be partially or entirely loaded, filled, coated, or otherwise incorporated with bioactive agents. Bioactive agents may be included in the implantable devices for a variety of reasons. For example, bioactive agents may be included in order to improve tissue in-growth into the implant, to improve tissue maturation, to provide for the delivery of an active agent, to improve wettability of the implant, to reduce the risk of infection, and to improve cell attachment- The bioactive agents may also be incorporated into the material composition of the substrate of the subunits.

[0056] The implantable devices can contain active agents designed to stimulate cell in-growth, including growth factors, cell adhesion factors including cell adhesion polypeptides, cellular differentiating factors, cellular recruiting factors, cell receptors, cellbinding factors, cell signaling molecules, such as cytokines, and molecules to promote cell migration, cell division, cell proliferation and extracellular matrix deposition. Such active agents include fibroblast growth factor (FGF), transforming growth factor (TGF), platelet derived growth factor (PDGF), epidermal growth factor (EGF), granulocyte-macrophage colony stimulation factor (GMCSF), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), hepatocyte growth factor (HGF), interleukin- 1-B (IL-1 B), interleukin-8 (IL-8), and nerve growth factor (NGF), and combinations thereof. As used herein, the term "cell adhesion polypeptides" refers to compounds having at least two amino acids per molecule that are capable of binding cells via cell surface molecules. The cell adhesion polypeptides include any of the proteins of the extracellular matrix which are known to play a role in cell adhesion, including fibronectin, vitronectin, laminin, elastin, fibrinogen, collagen types I, II, and V, as well as synthetic peptides with similar cell adhesion properties. The cell adhesion polypeptides also include peptides derived from any of the aforementioned proteins, including fragments or sequences containing the binding domains.

[0057] In some embodiments, the implantable devices may be loaded, filled, coated, or otherwise incorporated with wetting agents designed to improve the wettability of the various surfaces of the implantable devices to allow fluids to be easily adsorbed onto the implantable device surfaces, and to promote cell attachment and or modify the water contact angle of the implantable device surface. Examples of wetting agents include polymers of ethylene oxide and propylene oxide, such as polyethylene oxide, polypropylene oxide, or12845258.1WGS Ref. No.: D0188.70528WQ00- 18 - copolymers of these, such as PLURONICS®. Other suitable wetting agents may include surfactants or emulsifiers.

[0058] In some embodiments, the implantable devices may be loaded, filled, coated, or otherwise incorporated with gels, hydrogels or living hydrogel hybrids to further improve wetting properties and to promote cellular growth throughout the implantable device. Hydrogel hybrids may consist of living cells encapsulated in a biocompatible hydrogel like gelatin, methacrylated gelatin (GelMa), silk gels, and hyaluronic acid (HA) gels.

[0059] Other bioactive agents that can be incorporated in the implantable devices may include antimicrobial agents, in particular antibiotics, disinfectants, oncological agents, antiscarring agents, anti-inflammatory agents, anesthetics, small molecule drugs, anti-adhesion agents, inhibitors of cell proliferation, anti- angiogenic factors and pro- angiogenic factors, immunomodulatory agents, and blood clotting agents. The bioactive agents may be proteins such as collagen and antibodies, peptides, polysaccharides such as chitosan, alginate, hyaluronic acid and derivatives thereof, nucleic acid molecules, small molecular weight compounds such as steroids, inorganic materials such as hydroxyapatite and ceramics, or complex mixtures such as platelet rich plasma. Suitable antimicrobial agents include: bacitracin, biguanide, triclosan, gentamicin, minocycline, rifampin, vancomycin, cephalosporins, copper, zinc, silver, and gold. Nucleic acid molecules may include DNA, RNA, siRNA, miRNA, antisense or aptamers.

[0060] In some embodiments, the implantable devices may be loaded, filled, coated, or otherwise incorporated with allograft material and xenograft materials, including acellular dermal matrix material and small intestinal submucosa (SIS). In some embodiments, the implantable devices may incorporate systems for the controlled release of the therapeutic or prophylactic agents.

[0061] In some embodiments, the implantable devices may be loaded, filled, coated, or otherwise incorporated with allograft or xenograft tissue and cells prior to implantation, during implantation, or after implantation, or any combination thereof. In some embodiments, the implantable devices may be coated with autologous tissue and cells from the patient prior to implantation, during implantation, or after implantation, or any combination thereof. The autologous tissue and cells may include one or more of the following autologous fat, fat lipoaspirate, fat tissue, injectable fat, adipose tissue, adipose cells, fibroblast cells, and stem12845258.1WGS Ref. No.: D0188.70528WQ00- 19 - cells, including human adipose tissue-derived stem cells, also known as preadipocytes or adipose tissue-derived precursor cells, and fibroblast-like stem cells. In one embodiment, the implantable devices may be coated with autologous tissue and cells as described herein, and may also further include a vascular pedicle or other tissue mass.

[0062] In some embodiments, the polymers and copolymers composition of the implantable devices may have low moisture contents to ensure the implantable devices can be produced with stiffnesses comparable to natural tissue, prolonged strength retention, and good shelf life. In some embodiments, the polymers and copolymers that are used to prepare the implantable devices have a moisture content of less than 1,000 ppm (0.1 wt%), less than 500 ppm (0.05 wt%), less than 300 ppm (0.03 wt%), less than 100 ppm (0.01 wt%), and / or less than 50 ppm (0.005 wt%).

[0063] It should be appreciated that the compositions used to prepare the implantable devices may have a low endotoxin content. In some embodiments, the endotoxin content may be low enough so that the implantable devices produced from the polymer compositions have an endotoxin content of less than 20 endotoxin units per implantable device as determined by the limulus amebocyte lysate (LAL) assay. For example, the polymeric compositions used to prepare the implantable device may have an endotoxin content of <2.5 EU / g of polymer or copolymer. In another example, the P4HB polymer or copolymer, or PBS polymer of copolymer have an endotoxin content of <2.5 EU / g of polymer or copolymer.

[0064] In some embodiments, the implantable devices of the present disclosure may include one or more markers for external detection of the implantable device location. For example, an implantable device may include a radiopaque marker (e.g., a metallic tag, radio opaque materials), which may be visible and distinct over the nearby anatomy during x-ray imaging. The markers may be formed of any suitable extended use approved medical materials that may be medically imaged. Medical imaging may be performed using, for example, radiographic imaging modalities (e.g., x-ray imaging), magnetic resonance imaging (MRI), ultrasonography, fluoroscopy, or computed tomography. The marker may therefore be formed of any non-absorbable, biocompatible materials, which may refer to a material that does not cause any adverse reactions to a patient's health and that does not disintegrate over the lifetime of the patient. Non-absorbable, biocompatible materials may include, but are not limited to, metal containing materials, polymer materials, ceramic materials, or composite12845258.1WGS Ref. No.: D0188.70528WQ00- 20 - materials that include metals, polymers, or combinations of metals and polymers. Suitable metals may include, but are not limited to, gold, iridium, nickel, rhodium, silver, tantalum, titanium, stainless steel and alloys thereof, combinations thereof, and / or others. Suitable polymers include, but are not limited to, polyvinyl alcohol, polyurethanes, polyolefins, polyesters, polypropylenes, polyimides, polyetherimides, fluoropolymers, thermoplastic liquid polymers (LCP) such as, for example, Vectra® by Celanese, polyethylether ketones such as, for example, PEEK™ by Vitrex, polyamides, polycarbonates such as, for example, Makrolon® by Bayer Polymers, polysulfones, polyethersufones, polyphenylsulfones such as, for example, Radel® by Rowland Technologies, nylon, nylon copolymers, combinations thereof, and / or others. In some embodiments, the marker may include a shape-memory material, including, but not limited to, nitinol, titanium, or any shape-memory polymers.

[0065] The implantable devices of the present disclosure may be used in any suitable application. In some embodiments, the prostheses may be used along with implants (e.g., soft or hard tissue implants) following a procedure during treatment of cancers, such as breast, abdominal, liver, muscle, kidney, lung, and prostate cancer. In some embodiments, the implantable device may be used in soft tissue reconstruction applications, such that it may wrap around, partially enclose or fully encase a breast implant, breast lift implant, tissue expander, breast augmentation implant, nipple implant, facial reconstruction implant, buttock implant, malar augmentation device, cosmetic repair implant, soft tissue regeneration implant, hernia implant, hernia plug, wound healing implant, tissue engineering scaffold, scaffold for a vascular pedicle or other tissue mass, guided tissue repair / regeneration device, bulking or filling implant, void filler, implant for treatment of vesicoureteral reflux, cell seeded device, drug delivery device, cardiac rhythm management devices (CRM’s), pacemakers, defibrillators, pulse generators, implantable access systems, muscle and nerve stimulators, cochlear implants, ventricular assist devices, gastric stimulators, infusion pumps, drug pumps, neurostimulators, vagal nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, combinations thereof, and / or any other suitable application. In embodiments, the implant has a shape and size suitable for use in breast surgery procedures, including breast augmentation, breast reconstruction, and mastopexy.

[0066] “Absorbable” as generally used herein means the material is degraded in the body, and the degradation products are eliminated or excreted from the body. The terms12845258.1WGS Ref. No.: D0188.70528WQ00- 21 -“absorbable”, “resorbable”, “degradable”, and “erodible”, with or without the prefix “bio”, can be used interchangeably herein, to describe materials broken down and gradually absorbed, excreted, or eliminated by the body, whether degradation is due mainly to hydrolysis or mediated by metabolic processes.

[0067] “Bioactive agent” as generally used herein refers to therapeutic, prophylactic or diagnostic agents, agents that promote healing and the regeneration of host tissue, and also therapeutic agents that reduce the risks of infection. “Agent” includes a single such agent and is also intended to include a plurality.

[0068] “Biocompatible” as generally used herein means the biological response to the material or implantable device being appropriate for the implantable device's intended application in vivo. Any metabolites of these materials should also be biocompatible.

[0069] “Blend” as generally used herein means a physical combination of different polymers, as opposed to a copolymer formed of two or more different monomers.

[0070] “Breast implant” as generally used herein refers to any permanent, nonpermanent (e.g., degradable), or combinations thereof for an implant used in breast reconstructive procedures.

[0071] “Copolymers of poly-4-hydroxybutyrate” as generally used herein means any polymer containing 4-hydroxybutyrate with one or more different hydroxy acid units. The copolymers may be isotopically enriched.

[0072] “Copolymers of poly(butylene succinate)” as generally used herein means any polymer containing 1,4-butanediol and succinic acid units, and one or more different diol or diacid units. The copolymers may include one or more of the following: branching agent, cross-linking agent, chain extender agent, and reactive blending agent. The copolymers may be isotopically enriched.

[0073] “Endotoxin content” as generally used herein refers to the amount of endotoxin present in an implant or sample, and is determined by the limulus amebocyte lysate (LAL) assay.

[0074] “Poly-4-hydroxybutyrate” as generally used herein means a homopolymer containing 4-hydroxybutyrate units. It can be referred to herein as P4HB or TephaFLEX® biomaterial (manufactured by Tepha, Inc., Lexington, Mass.). The polymers may be isotopically enriched.12845258.1WGS Ref. No.: D0188.70528WQ00- 22 -

[0075] Tether” as used herein may refer to any generally flexible and approximately one-dimensional structure formed from one or more yarns, fibers, strings, ribbons, strands, threads, sutures, monofilaments, and / or multifilaments. Such structures may comprise knits, braids, woven materials, non-woven materials, combinations thereof, and / or any other suitable form factor. The cord materials of the present disclosure may be formed of any suitable biocompatible material or combination of materials, bioabsorbable and / or non- bioabsorbable.

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

[0077] Fig. 1 depicts an implantable device 100 of the present disclosure. In some embodiments, an implantable device 100 may be formed of a repair fabric material as disclosed herein (e.g., a mesh, a woven material, a nonwoven material, a knitted material, a braided material, a felted fabric, combinations thereof, and / or any other suitable types of repair fabric). Further, in some embodiments, an implantable device 100 may include a pocket portion 102 and a funnel portion 104. In some embodiments, the pocket portion 102 and the funnel portion 104 may be formed continuously, such that the implantable device 100 has a single, unitary construction. In other embodiments, the pocket portion 102 and the funnel portion 104 may be formed separately and joined together to form the implantable device 100. Further, in some embodiments, the pocket portion 102 and the funnel portion 104 may be formed from the same or different materials, including the same or different repair fabric materials.

[0078] In some embodiments, the pocket portion 102 may define a pocket internal to the implantable device 100. The pocket may be sized and shaped to receive an implantable prosthetic 106. In some embodiments and as shown, the implantable prosthetic 106 may be a breast implant, although other prosthetics are also contemplated, as are other types of implants as described above. As shown in Fig. 1, the prosthetic 106 may be disposed within the pocket of the pocket portion 102. The pocket portion 102 may have a proximal end portion 108 and a distal end portion 110 opposite the proximal end portion. An opening 11212845258.1WGS Ref. No.: D0188.70528WQ00- 23 - may be disposed at the distal end portion of the pocket portion 102 and may be configured to permit passage of the prosthetic 106 into the pocket. The opening 112 may be sized, positioned, or otherwise configured to correspond to an incision formed in a subject during a procedure, such as an inframammary incision, through which the pocket portion is configured to be inserted.

[0079] In some embodiments, the funnel portion 104 may also include a proximal end portion 114 and a distal end portion 116 opposite the proximal end portion 114. In some embodiments, the at least part of the funnel portion 104 may be configured to extend out of a breast pocket and / or out from an inframammary incision when the pocket portion 102 is disposed within the breast pocket. For example, the distal end portion 116 may be configured to extend out from the breast pocket / inframammary incision. A distal opening 118 may be disposed at the distal end portion 116 of the funnel portion 104 and may be configured to permit passage of the prosthetic 106 into an internal channel of the funnel portion 104. The internal channel may extend between the proximal end portion 114 and the distal end portion 116 and may allow communication between the distal opening 118 of the funnel portion 104 and the opening 112 of the pocket portion 102.

[0080] In some embodiments, a width of the funnel portion 104 may be greater at the distal end portion 116 than at the proximal end portion 114, such that the funnel portion tapers from the distal end portion 116 to the proximal end portion 114. In some embodiments, a taper angle 120 of the funnel portion 104 may be measured as an angle between a wall and a longitudinal centerline of the funnel portion 104. In various embodiments, the taper angle 120 may be any appropriate angle as discussed above. For example, in some embodiments, a taper angle 120 may be between about 10 degrees and about 15 degrees, although other taper angles are also contemplated as discussed above.

[0081] At least the pocket portion of the implantable device may be configured to be inserted into the body of a subject. For example, when a breast pocket has been formed in the subject, the pocket portion may be insertable into the breast pocket. The implantable device may be configured to be secured in place within the breast pocket using any appropriate securement method or device, including tethers (e.g., yams, fibers, strings, ribbons, strands, threads, sutures, monofilaments, multifilaments, and / or others), staples, adhesive, and / or any other appropriate securement or combination of securements. In some embodiments, a12845258.1WGS Ref. No.: D0188.70528WQ00- 24 - material of the implantable device 100 and / or pocket portion 102 thereof (e.g., a repair fabric material) may be configured to be pierced or otherwise passed through by a securement such as a tether or a staple, such that the securement may pass through the material and into a tissue of the subject to secure the device 100 in place. Additionally or alternatively, in some embodiments, the implantable device may be secured in place using pressure (e.g., by pressing the material against and / or into the subject’s tissue).

[0082] In some embodiments, various dimensions of an implantable device 100 may be selected based on the dimensions of a corresponding implantable prosthetic 106. For example, a length 122 (i.e., a distance between the distal opening 118 and the proximal opening 112) and / or a width 124 of the funnel portion 104 may be selected based on a length and / or width of the implantable prosthetic. In some embodiments, the proximal opening 112 may coincide with, be continuous with, or be formed as the same opening as the opening 112 formed in the distal end portion 110 of the pocket portion 102. In some embodiments, the length 122 of the funnel portion may be selected such that the implantable prosthetic may be inserted into the funnel portion 104 (i.e., through the distal opening 118) to a depth that may permit the funnel portion 104 to fully enclose the implantable prosthetic 104, or to facilitate a no-contact procedure, as discussed above. Thus, the length 122 may be selected based at least in part on a length 126 of the implantable prosthetic 106. Additionally, as noted above, the width 124 may taper from a first greater width at the distal opening 118 to a second smaller width at the proximal opening. In some embodiments, the width 124 at the distal opening 118 may be between about 10 cm and about 25 cm, as discussed above. Further, in some embodiments, the width 124 at the proximal opening 112 may be between about 5 cm and about 10 cm, or between about 12.5 cm and about 17.5 cm, as discussed above.

[0083] Further to the above, in some embodiments, various dimensions of the pocket portion 102 may be selected based on a size of the implantable prosthetic 106. For example, a width 128 of the pocket portion 102 may be selected based, at least in part, on a width 130 of the implantable prosthetic 106 (e.g., to prevent wrinkling, folding, separation from the prosthetic, and / or other deformations in the material of the implantable device which may result from excess material). In some embodiments, the width 128 of the pocket portion 102 may be between about 8 cm and about 20 cm, as discussed above.12845258.1WGS Ref. No.: D0188.70528WQ00- 25 -

[0084] Figs. 2A-2D depict operation of an implantation device 100 in conjunction with an implantable prosthetic 106. As shown in Fig. 2A, the prosthetic 106 may be inserted into the funnel portion 104 through the distal opening 118. As shown in Fig. 2B, the prosthetic 106 may urged along the funnel portion 104 (i.e., through the channel of the funnel portion) towards the proximal opening 112. In some embodiments, the prosthetic 106 is urged in the proximal direction by compressing or squeezing material of the funnel portion 104 that is on a distal side of the prosthetic 106. For example, a tail end 132 of the funnel portion 104 may be formed on the distal side of the prosthetic 106 when the prosthetic 106 is inserted into and / or urged along the funnel portion 104. The tail end 132 may be squeezed or compressed to urge the prosthetic 106 in the proximal direction. In some embodiments, the tail end 132 may be configured to be squeezed or compressed around the prosthetic 106 such that the prosthetic 106 is not exposed through the distal opening 118, thereby facilitating a no-contact procedure as described herein. Similarly, the step of inserting the prosthetic 106 into the funnel portion 104 may additionally or alternatively be performed without the surgeon directly contacting the prosthetic 106 to facilitate a no-contact procedure.

[0085] As noted above, in some embodiments, some or all of the funnel portion 104 may be removable from the implantable device 100. For example, as shown in Fig. 2C, the funnel portion 104 may include a removable portion 133. In various embodiments, the removable portion 133 may be any appropriate portion of the funnel portion 104, including all or substantially all of the funnel portion 104. As shown in Fig. 2C, the removable portion 133 may be less than an entirety of the funnel portion 104, such that a stub portion 134 may remain extending from the pocket portion 102 after removal of the removable portion 133. In other embodiments, the removable portion 133 may comprise all or substantially all of the funnel portion, such that no stub portion remains on the implantable device 100. Further, in various embodiments, the removable portion 133 may be removed using any appropriate tool or method, including cutting, tearing, or otherwise separating the removable portion 133. For example, in some embodiments, the removable portion 133 may be configured to be removed using a blade (e.g., a scalpel, a knife, a razor, or other bladed cutting implement), shears, scissors, electrocautery devices, or any other appropriate cutting implement.

[0086] In embodiments which include a stub portion 134, the stub portion 134 may be utilized to close the opening 112 of the pocket portion 102. For example, as shown in Fig.12845258.1WGS Ref. No.: D0188.70528WQ00- 26 -2D, the stub portion 134 may be folded around the distal end portion 110 of the pocket portion 102 to close the opening 112. In some embodiments, the stub portion 134 may be folded between the pocket portion 102 and a tissue of the subject, such as a chest wall, breast tissue, or other tissue. Further, in some embodiments, the stub portion 134 may be secured in the folded position, for example using tethers (e.g., yarns, fibers, strings, ribbons, strands, threads, sutures, monofilaments, multifilaments, and / or others), staples, adhesives, and / or any other appropriate securement or combination of securements.

[0087] Figs. 3 A-4C illustrate implantation devices configured to facilitate positioning within the breast pocket during a procedure. In some embodiments, an implantation device 100 or a pocket portion 102 thereof may include or be coupled to a tether 136 configured to facilitate positioning within a breast pocket 138 of a subject, for example along a longitudinal axis 140 of the subject. In some embodiments, the tether 136 may pass through a proximal end portion 142 of the pocket portion 102. For example, in the embodiment shown, the tether 136 may pass from an external side of the pocket portion 102 and into the pocket of the pocket portion 102 at a first location 144 A. The tether 136 may further pass from within the pocket to the external side of the pocket portion 102 at a second location 144B.

[0088] In some embodiments, the tether 136 may be configured to act as a pulley to permit an operator to adjust the positioning of the pocket portion 102 along the longitudinal axis 140 by pulling on a terminal end of the tether 136. For example, as shown in Figs. 3A- 3C, the tether 136 may include a first pulley section 148 A and a second pulley section 148B, each configured to act as a pulley. The pulley sections 148 A, 148B may extend away from the pocket portion 102 from respective locations 144 A, 144B on the pocket portion 102, and may be configured to be threaded into and / or embedded in the breast pocket 138 or other tissue (e.g., the chest wall) of the subject. In some embodiments, the tether 136 may be configured to pull the implantable device 100 towards the tissue (e.g., towards the section of tissue in which a pulley section 148A, 148B is embedded) in response to tension applied to one or more terminal ends of the tether 136. For example, as shown in Fig. 3B, tension may be applied to the free ends 150A, 150B of the tether 136 in a generally distal direction such as the direction of arrows 146A, 146B (e.g., by pulling the free ends in the distal direction). This tension may cause the tether 136 to be pulled around the pulleys formed in the tissue of the12845258.1WGS Ref. No.: D0188.70528WQ00- 27 - breast pocket 138, thereby pulling the pocket portion 102 along the longitudinal axis 140 (e.g., in the direction of arrow 152).

[0089] In some embodiments, the locations 144 A, 144B may be configured to prevent movement of the tether 136 through the material of the pocket portion 102. For example, in some embodiments, the tether 136 may be constrained at the locations 144 A, 144B by an adhesive, a knot, or any other appropriate constraint to prevent the tether from being pulled through the material of the pocket portion 102 (i.e., to ensure that tension applied to either of the free ends 150A, 150B will displace the pocket portion 102 rather than simply displacing the tether through the material).

[0090] As discussed above, it may be beneficial in some instances to position the pocket portion 102 in or near a superior region of a breast pocket. For example, in some embodiments, such positioning may facilitate a teardrop shape and / or other desired anatomical shape. In some embodiments, the tethers described herein may be configured to facilitate such superior positioning of the pocket portion 102. For example, as shown in Fig. 3D, the breast pocket 138 may include a superior end region 156 and an inferior end region 158. The tether 136 of Fig. 3D may be operated as described above to position the pocket portion 102 such that a proximal end portion 108 of the pocket portion 102 is disposed in the superior end region 156 of the breast pocket 138. As further shown in Fig. 3D, the locations 144 A, 144B may be pulled into close proximity with (or into direct contact with) a maximum superior region of the superior end region 156, such that the proximal end portion 108 of the pocket portion 102 may be positioned within the superior end regionl56 of the breast pocket 138.

[0091] Further, in some embodiments, the pocket portion 102 may be secured in placed after being positioned at a desired location. For example, once the proximal end portion 108 of the pocket portion 102 has been positioned at the desired location of the breast pocket 138 (e.g., in the superior end region 156 or other area of the breast pocket), first and second securements 154 A, 154B may be placed in the pocket portion 102 to secure the pocket portion 102 at the desired location. As shown in Fig. 3D, the securements 154A, 154B may be placed in the distal end portion 110 of the pocket portion 102, as the distal end portion 110 may be easily accessible (e.g., via an inframammary incision in or near the inferior end region 158 of the breast pocket 138). In other embodiments, securements may be12845258.1WGS Ref. No.: D0188.70528WQ00- 28 - placed at any desired location, as the present disclosure is not particularly limited in this regard. In various embodiments, securements 154A, 154B may comprise any appropriate tethers (e.g., sutures or others), staples, adhesives, and / or any other appropriate securement or combination of securements.

[0092] Figs. 4A-4C illustrate implantable devices which operate similarly to the devices of Figs. 3A-3D, in that the terminal ends 150A, 150B of the tether 136 may be tensioned (e.g., pulled) to adjust a position of the pocket portion 102 along the longitudinal axis 140. However, as illustrated in Figs. 4A-4C, in some embodiments, the tether 136 may include a first knot 160, a second knot 162, and an anchor point 164. The tether 136 may pass through a tissue of the breast pocket 138 at the anchor point 164. In some embodiments, the first knot 160 may be formed in the tether 136 on a first side of the pocket portion 102 (e.g., an external side), and the second knot 162 may be formed on a second side of the pocket portion opposite the first side (e.g., an internal side). In some embodiments, tensioning of the terminal ends 150A, 150B may tighten one or both of the knots 160, 162, thereby adjusting the position of the pocket portion 102 relative to the breast pocket 138. For example, tension may be applied to the free ends 150A, 150B of the tether in the direction of arrows 146A, 146B (e.g., by pulling the free ends). This tension may cause one or both of the knots 160, 162 to tighten, thereby pulling the pocket portion 102 along the longitudinal axis 140 closer to the anchor point 164 (e.g., in the direction of arrow 152). The implantable devices illustrated in Figs. 4A-4C are similar in other respects to the implantable devices illustrated in Figs. 3A-3D.

[0093] As further discussed above, an implantable device may be configured to facilitate tightening of the implantable device around an implantable prosthetic disposed therein. For example, the implantable device may include one or more compressive zones. As shown in Figs. 5A-5B, an implantable device 100 may include a first compressive zone 164A and a second compressive zone 164B. In some embodiments, a compressive zone may extend around at least a portion of a perimeter of a pocket portion of an implantable device, and may have a width extending inwardly from the perimeter. For example, in some embodiments, the first compressive zone 164 A and / or the second compressive zone 164B may extend between a proximal end portion 108 and a distal end portion 110 of the pocket portion 102, and may have a width 166 extending inwardly from an outer perimeter of the pocket portion 102. In12845258.1WGS Ref. No.: D0188.70528WQ00- 29 - some embodiments, a first and second compressive zone 164 A, 164B may be separated in a distal end portion 110 of the pocket portion 102. In various embodiments, the first and second compressive zones 164A, 164B may be separated by any appropriate distance or spacing around the perimeter of the pocket portion 102. For example, as shown in Fig. 5 A, the compressive zones 164 A, 164B may be spaced apart by a sweep angle 165. In embodiments, the sweep angle 165 may be any appropriate angle, including about 5°, about 10°, about 15°, about 30°, about 45°, about 90°, about 180°, or any other appropriate angle. Alternatively, in some embodiments, there may be no spacing between compressive zones. Rather, the compressive zones may be adjacent to one another, or only a single compressive zone may extend around at least a portion of the perimeter of the pocket portion.

[0094] In some embodiments, a tether may pass through the pocket portion at a plurality of locations within a compressive zone. For example, a first tether 168 A may pass through the pocket portion 102 at a first plurality of locations 170A in the first compressive zone 164A, and / or a second tether 168B may pass through the pocket portion 102 at a second plurality of locations 170B in the second compressive zone 164B. In some embodiments, a plurality of locations 170A, 170B through which a tether 168 A, 168B is passed may be selected to arrange the tether in a substantially periodic pattern across the compressive region. In various embodiments, the periodic pattern may have any appropriate parameter as discussed above. For example, a distance 177 between consecutive peaks or troughs of the periodic pattern may be between about 4 mm and about 6 mm, although other distances are also contemplated as discussed above. In some embodiments, the locations 170A, 170B may vary or alternate with respect to their distance from the outer perimeter of the pocket portion 102. For example, in some embodiments, a first location may be spaced at a first distance (e.g., a first radial distance) from the outer perimeter, while a second location (which may be adjacent to the first location in some embodiments) may be spaced at a second distance from the outer perimeter, the second distance being different from the first distance.

[0095] Each tether 168 A, 168B may have a respective terminal end 172 A, 172B. In operation, tension may be applied to one or both of the terminal ends 172 A, 172B to constrict the corresponding compressive zone(s), for example by pulling the terminal end(s). In some embodiments, applying tension to a terminal end 172 A, 172B may reduce a dimension of the corresponding compressive zone. In some embodiments, applying tension to a terminal end12845258.1WGS Ref. No.: D0188.70528WQ00- 30 -172 A, 172B may compress a periodic pattern of the tether in one or more dimensions to reduce the corresponding dimension(s) of the compressive zone. As will be appreciated by comparison of Fig. 5 A with Fig. 5B, in some embodiments, applying tension to terminal end(s) 172 A, 172B in the direction of arrow(s) 174 A, 174B may further reduce a width 166 of a corresponding compressive zone 164A, 164B from a first width (Fig. 5 A) to a reduced second width (Fig. 5B). As will be further appreciated with reference to Figs. 7A-7B and 8A- 8B, in some embodiments, applying tension to terminal end(s) 172 A, 172B in the direction of arrow(s) 174A, 174B may additionally or alternatively reduce a height 176 of a corresponding compressive zone 164 A, 164B from a first height to a reduced second height. In some embodiments, the height 176 may extend between a front face 188 and a rear face 190 of the pocket portion 102, although it will be appreciated that the height 176 need not extend the full distance between the front face 188 and the rear face 190, as the height 176 may be selected to achieve a desired degree of compression and may thus be any appropriate distance between the front face 188 and the rear face 190.

[0096] As further shown in Fig. 6, an implantable device 100 may be formed in a clamshell arrangement having a first panel 180, a second panel 182, and a living hinge 184 hingedly connecting the first and second panels 180, 182. In some embodiments, the living hinge 184 may be a continuous section of material extending between and connecting the first and second panels 180, 182. Further, the living hinge 184 may be configured to permit the first and second panels 180, 182 to be folded towards one another during assembly or operation of the implantable device 100 (i.e., to permit the first panel to be folded towards the second panel, and / or vice versa). For example, as illustrated in Figs. 7A-7B, an implantable device 100 may be assembled by folding the second panel 182 towards the first panel 180 about the living hinge 184, and inserting the tether 168 A through the plurality of locations 170A within the compressible zone 164A. Thus, tensioning the terminal end 172A of the tether 168 A to reduce the height 176 of the compressible zone 164A may draw the first and second panels 180, 182 closer together (i.e., to tighten the second panel 182 against the first panel 180, which may be secured in place within the breast pocket by tethers 154A, 154B, and / or 136). Tensioning the terminal end 172A of the tether 168A may therefore cause the compressive zone to be constricted around an implantable prosthetic 106 disposed within the implantable device 100. Further, as shown in the figures, the living hinge 184 may be12845258.1WGS Ref. No.: D0188.70528WQ00- 31 - disposed at a proximal end portion 108, and may be disposed between a first compressive zone 164 A and a second compressive zone 164B. In some embodiments, the living hinge 184 may be disposed opposite the opening 112 at the distal end portion 110, such that the first and second compressive zones 164 A, 164B may be spaced apart by the living hinge 184 at the proximal end portion 108 and by the opening 112 at the distal end portion 110.

[0097] Although Figs. 7A-7B illustrate compressive zones implemented in implantable devices having a clamshell construction, it should be appreciated compressive zones are not limited to use with clamshell devices. Rather, compressive zones as described herein may implemented in implantable devices having any appropriate construction, including constructions in which the walls of the device or a pocket portion thereof are continuous (except where an opening may be formed to permit insertion of a prosthetic implant. For example, as shown in Figs. 8A-8B, some implantable devices 100 may include a continuous sidewall 186. In some embodiments, implantable devices with a continuous sidewall 186 may operate similarly to the clamshell devices of Figs. 7A-7B, in that the terminal end(s) 172A, 172B of the tether(s) 172A, 172B may be tensioned (e.g., pulled) to constrict a corresponding compressive zone 164 A, 164B around an implantable prosthetic 106 (e.g., by reducing a height, width, length and / or other dimension of the corresponding compressive zone).

[0098] As illustrated in Fig. 9, a method of using an implantable device may include, at step 900, inserting a pocket portion of the implantable device into a pocket formed in a body of a subject. In some embodiments, the pocket formed in the body of the subject may be a breast pocket, and the pocket portion may be sized and shaped to be inserted into the breast pocket.

[0099] At step 902, an implantable prosthetic may be inserted into a funnel portion of the implantable device. In some embodiments, the funnel portion may be attached to and extending from the pocket portion. Further, in some embodiments, the funnel portion may extend out from the pocket formed in the body of the subject.

[0100] At step 904, the implantable prosthetic may be passed through the funnel portion and into the pocket portion. In some embodiments, passing the implantable prosthetic through the funnel portion may include urging the prosthetic along a channel of the funnel portion. For example, in some embodiments, a tail end of the funnel portion may be formed12845258.1WGS Ref. No.: D0188.70528WQ00- 32 - at a location distal to the prosthetic, and the tail end may be squeezed or compressed to urge the prosthetic along the channel. In some embodiments, the tail end may be used to constrain movement of the prosthetic in a distal direction while urging the prosthetic in a proximal direction (i.e., towards the pocket portion). Furthermore, passing the implantable prosthetic through the funnel portion may include passing the prosthetic through an opening in a distal end portion of the pocket portion. In some embodiments, this step may be performed as a nocontact procedure without directly contacting the prosthetic (i.e., without contacting the prosthetic using a glove or a hand), but rather by contacting the funnel portion.

[0101] At step 906, at least part of the funnel portion may be removed from the implantable device. In various embodiments, removing part of the funnel portion may include removing all or substantially all of the funnel portion, or a majority of the funnel portion. In some embodiments, removing at least part of the funnel portion may include leaving a stub portion attached to the pocket portion of the device. Some such embodiments may further include folding the stub portion against the pocket portion to close an opening of the pocket portion, for example by folding the stub portion between the pocket portion (or a distal end portion thereof) and a tissue of the subject such as a chest wall. Further, in some embodiments, removing at least part of the funnel portion may include cutting, tearing, or otherwise separating the part of the funnel portion.

[0102] Any of the methods described herein may be performed as a no-contact procedure without directly contacting the prosthetic or the pocket portion (i.e., without contacting the prosthetic or pocket portion using a glove or a hand), for example to avoid contaminating items which are implanted into the subject.

[0103] Each embodiment described herein may be implemented as a method. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0104] While several embodiments of the present invention have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the functions and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications12845258.1WGS Ref. No.: D0188.70528WQ00- 33 - is deemed to be within the scope of the present invention. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the teachings of the present invention is / are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the invention may be practiced otherwise than as specifically described and claimed. The present invention is directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the scope of the present invention.12845258.1

Claims

WGS Ref. No.: D0188.70528WQ00- 34 -CLAIMS1. An implantable device, comprising: a pocket portion defining a pocket, wherein the pocket is sized and shaped to receive an implantable prosthetic, the pocket portion configured to be inserted within a body of a subject; and a funnel portion attached to and extending from the pocket portion, the funnel portion defining a channel, the funnel portion configured to permit passage of the implantable prosthetic through the channel and into the pocket while the pocket portion is within the body of the subject, wherein at least part of the funnel portion is configured to be removed from the implantable device while the pocket portion is within the body of the subject.

2. The implantable device of claim 1, wherein the implantable device comprises a biocompatible prosthetic repair fabric material.

3. The implantable device of claim 2, wherein the biocompatible prosthetic repair fabric material comprises a mesh.

4. The implantable device of claim 3, wherein the biocompatible prosthetic repair fabric material comprises poly-4-hydroxybutyrate (P4HB).

5. The implantable device of claim 4, wherein the pocket portion and the funnel portion are formed as a continuous mesh.

6. The implantable device of claim 1, wherein the channel extends from an opening at a distal end portion of the pocket portion to a distal opening of the funnel portion.

7. The implantable device of claim 6, wherein the opening of the pocket portion has a width corresponding to a size of an incision through which the pocket portion is configured to be inserted.12845258.1WGS Ref. No.: D0188.70528WQ00- 35 -8. The implantable device of claim 7, wherein the width of the opening is about 12.5 cm to about 17.5 cm.

9. The implantable device of claim 7, wherein the width of the opening is about 5 cm to about 10 cm.

10. The implantable device of claim 1, wherein the funnel portion tapers from a proximal end portion adjacent to the pocket portion to a distal end portion.

11. The implantable device of claim 10, wherein a taper angle of the funnel portion is between about 10 degrees and about 15 degrees.

12. The implantable device of claim 1, wherein a distal opening of the funnel portion has a width of about 10 cm to about 25 cm13. The implantable device of claim 1, wherein the pocket portion has a width of about 8 cm to about 20 cm.

14. The implantable device of claim 1, wherein the funnel portion has a length of about 20 cm to about 35 cm.

15. The implantable device of claim 1, wherein the funnel portion is formed in a substantially two-dimensional geometry.

16. The implantable device of claim 1, wherein the funnel portion is formed in a three- dimensional geometry.

17. The implantable device of claim 1, wherein at least part of the funnel portion is configured to inhibit contaminants from passing through a wall of the funnel portion12845258.1WGS Ref. No.: D0188.70528WQ00- 36 -18. The implantable device of claim 1, wherein the implantable prosthetic comprises a breast implant.

19. A method of using an implantable device, the method comprising: inserting a pocket portion of the implantable device into a pocket formed in a body of a subject; inserting an implantable prosthetic into a funnel portion of the implantable device, the funnel portion attached to and extending from the pocket portion, wherein the funnel portion extends out from the pocket formed in the body of the subject; passing the implantable prosthetic through the funnel portion and into the pocket portion; and removing at least a part of the funnel portion from the implantable device.

20. The method of claim 19, wherein the method is performed without contacting the implantable prosthetic with a hand or glove.

21. The method of claim 19, wherein removing at least the part of the funnel portion comprises cutting the funnel portion.

22. The method of claim 19, wherein removing the at least the part of the funnel portion comprises removing a first part of the funnel portion and leaving a second part of the funnel portion attached to the pocket portion.

23. The method of claim 22, the method further comprising folding the second part of the funnel portion against the pocket portion.

24. The method of claim 23, wherein folding the second part of the funnel portion against the pocket portion comprises folding the second part of the funnel portion between the pocket portion and a chest wall of the subject.12845258.1WGS Ref. No.: D0188.70528WQ00- 37 -25. The method of claim 19, wherein passing the implantable prosthetic through the funnel portion comprises constraining movement of the implantable prosthetic in a distal direction through the funnel portion with a tail end of the implantable funnel located distally from the implant while urging the implantable prosthetic through the funnel portion in a proximal direction towards the pocket portion.

26. The method of claim 19, wherein passing the implantable prosthetic through the funnel portion comprises passing the implantable prosthetic through an opening in a distal end portion of the pocket portion.

27. The method of claim 19, wherein the funnel portion tapers from a proximal end adjacent to the pocket portion to a distal end.

28. The method of claim 27, wherein a taper angle of the funnel portion is between about 10 degrees and about 15 degrees.

29. The method of claim 19, wherein a distal opening of the funnel portion has a width of about 10 cm to about 25 cm30. The method of claim 19, wherein the pocket portion has a width of about 8 cm to about 20 cm.

31. The method of claim 19, wherein the funnel portion has a length of about 20 cm to about 35 cm.

32. The method of claim 19, wherein the funnel portion is formed in a substantially two- dimensional geometry.

33. The method of claim 19, wherein the funnel portion is formed in a three-dimensional geometry.12845258.1WGS Ref. No.: D0188.70528WQ00- 38 -34. The method of claim 19, wherein at least part of the funnel portion is configured to inhibit contaminants from passing through a wall of the funnel portion35. The method of claim 19, wherein the implantable prosthetic comprises a breast implant.

36. An implantable device, comprising: a pocket portion defining a pocket, wherein the pocket is sized and shaped to receive an implantable prosthetic, the pocket portion having a distal end portion including an opening configured to permit passage of the implantable prosthetic into the pocket, the pocket portion configured to be inserted within a body of a subject; and at least one tether passing through the pocket portion at a plurality of locations disposed within at least one compressive zone of the pocket portion, each compressive zone of the at least one compressive zone extending around at least a portion of an outer perimeter of the pocket portion from the distal end portion to a proximal end portion opposite the distal end portion and having a width extending inwardly from the outer perimeter of the pocket portion, the at least one tether configured to constrict the at least one compressive zone around the implantable prosthetic by reducing the width of the at least one compressive zone in response to tension applied to the at least one tether.

37. The implantable device of claim 36, the at least one compressive zone further comprising a height extending between a front face of the pocket portion and a rear face of the pocket portion, the at least one tether configured to constrict the compressive zone by reducing the height.

38. The implantable device of claim 37, wherein the height of the at least one compressive zone is between about 2 cm and about 6 cm.

39. The implantable device of claim 36, wherein the at least one compressive zone comprises at least a first compressive zone and a second compressive zone, and wherein the at least one tether comprises at least:12845258.1WGS Ref. No.: D0188.70528WQ00- 39 - a first tether passing through the pocket portion at a first plurality of locations disposed in the first compressive zone; and a second tether passing through the pocket portion at a second plurality of locations disposed in the second compressive zone.

40. The implantable device of claim 38, wherein the first tether and the second tether are disposed on opposing sides of the pocket portion.

41. The implantable device of claim 38, wherein the first compressive zone and the second compressive zone are spaced apart.

42. The implantable device of claim 40, wherein a living hinge of the pocket portion is formed between the first and second compressive zones.

43. The implantable device of claim 40, wherein the first compressive zone and the second compressive zone are spaced apart by a sweep angle around the outer perimeter of about 15 degrees or less.

44. The implantable device of claim 40, wherein the first and second compressive zones are spaced apart at both the proximal end portion and the distal end portion.

45. The implantable device of claim 40, wherein the opening of the pocket portion is disposed between the first and second compressive zones.

46. The implantable device of claim 40, wherein the opening of the pocket portion has a width of about 5 cm to about 10 cm.

47. The implantable device of claim 40, wherein the opening of the pocket portion has a width of about 12.5 cm to about 17.5 cm.12845258.1WGS Ref. No.: D0188.70528WQ00- 40 -48. The implantable device of claim 40, wherein the locations of the plurality of locations are selected to arrange the tether in a substantially periodic pattern across the compressive zone.

49. The implantable device of claim 48, wherein at least one pair of consecutive peaks in the substantially periodic pattern are spaced apart by about 4 mm to about 6 mm .

50. The implantable device of claim 41, wherein the width of the compressive zone extends at least about 5 mm inwardly from the outer perimeter.

51. The implantable device of claim 41, wherein the pocket portion comprises a biocompatible prosthetic repair fabric material.

52. The implantable device of claim 51, wherein the biocompatible prosthetic repair fabric material comprises P4HB.

53. The implantable device of claim 41, wherein the pocket portion has a diameter of about 8 cm to about 20 cm.

54. A method of using an implantable device, the method comprising: inserting an implantable prosthetic into a pocket portion of the implantable device, the pocket portion having a distal end portion including an opening configured to permit passage of the implantable prosthetic into the pocket; and applying tension to at least one tether of the implantable device to constrict at least one compressive zone of the pocket portion around the implantable prosthetic, each compressive zone of the at least one compressive zone extending around at least a portion of an outer perimeter of the pocket portion from the distal end portion to a proximal end portion opposite the distal end portion and having a width extending inwardly from the outer perimeter of the pocket portion, wherein applying tension to the at least one tether reduces the width of the at least one compressive zone.12845258.1WGS Ref. No.: D0188.70528WQ00- 41 -55. The method of claim 54, the at least one compressive zone further comprising a height extending between a front face of the pocket portion and a rear face of the pocket portion, wherein applying tension to the at least one tether further reduces the height of the compressive zone.

56. The method of claim 55, wherein the height of the at least one compressive zone is between about 2 cm and about 6 cm.

57. The method of claim 54, wherein the at least one compressive zone comprises at least a first compressive zone and a second compressive zone, and wherein the at least one tether comprises at least: a first tether passing through the pocket portion at a first plurality of locations disposed in the first compressive zone; and a second tether passing through the pocket portion at a second plurality of locations disposed in the second compressive zone.

58. The method of claim 57, wherein the first tether and the second tether are disposed on opposing sides of the pocket portion.

59. The method of claim 57, wherein the first compressive zone and the second compressive zone are spaced apart.

60. The method of claim 59, wherein a living hinge of the pocket portion is formed between the first and second compressive zones.

61. The method of claim 59, wherein the first compressive zone and the second compressive zone are spaced apart by a sweep angle around the outer perimeter of about 15 degrees or less.

62. The method of claim 59, wherein the first and second compressive zones are spaced apart at both the proximal end portion and the distal end portion.12845258.1WGS Ref. No.: D0188.70528WQ00- 42 -63. The method of claim 59, wherein the opening of the pocket portion is disposed between the first and second compressive zones.

64. The method of claim 54, wherein the opening of the pocket portion has a width of about 5 cm to about 10 cm.

65. The method of claim 54, wherein the opening of the pocket portion has a width of about 12.5 cm to about 17.5 cm.

66. The method of claim 54, wherein the locations of the plurality of locations are selected to arrange the tether in a substantially periodic pattern across the compressive zone.

67. The method of claim 66, wherein at least one pair of consecutive peaks in the substantially periodic pattern are spaced apart by about 4 mm to about 6 mm.

68. The method of claim 54, wherein the width of the compressive zone extends at least about 5 mm inwardly from the outer perimeter.

69. The method of claim 54, wherein the pocket portion comprises a biocompatible prosthetic repair fabric material.

70. The method of claim 51, wherein the biocompatible prosthetic repair fabric material comprises P4HB.

71. The method of claim 54, wherein the pocket portion has a diameter of about 8 cm to about 20 cm.

72. An implantable device, comprising: a pocket portion defining a pocket, wherein the pocket is sized and shaped to receive an implantable prosthetic, the pocket portion having a distal end portion including an opening12845258.1WGS Ref. No.: D0188.70528WQ00- 43 - configured to permit passage of the implantable prosthetic into the pocket, the pocket portion configured to be inserted within a body of a subject; and a tether passing through a proximal end portion of the pocket portion opposite the distal end portion, the tether configured to facilitate positioning of the implantable device within the body of the subject along a longitudinal axis of the subject.

73. The implantable device of claim 72, wherein the tether passes from an external side of the pocket portion into the pocket at a first location on the pocket portion, and from within the pocket to the external side of the pocket portion at a second location on the pocket portion.

74. The implantable device of claim 73, wherein the tether includes a first pulley section extending from the first location on the external side of the pocket portion and a second pulley section extending from the second location on the external side of the pocket portion, the first and second pulley sections configured to be passed through tissue of the subject to form respective pulleys, each of the first and second pulley sections connected to a respective terminal end, wherein the tether is configured to change a position of the implantable device in response to tension applied to one or both of the terminal ends.

75. The implantable device of claim 73, wherein the tether includes a first knot disposed in the pocket of the pocket portion, a second knot disposed on the external side of the pocket portion.

76. The implantable device of claim 72, wherein the implantable device comprises a biocompatible prosthetic repair fabric material.

77. The implantable device of claim 76, wherein the biocompatible prosthetic repair fabric material comprises a mesh.

78. The implantable device of claim 77, wherein the biocompatible prosthetic repair fabric material comprises P4HB.12845258.1WGS Ref. No.: D0188.70528WQ00- 44 -79. The implantable device of claim 72, wherein the opening of the pocket portion has a width corresponding to a size of an incision through which the pocket portion is configured to be inserted.

80. The implantable device of claim 79, wherein the width of the opening is about 12.5 cm to about 17.5 cm.

81. The implantable device of claim 79, wherein the width of the opening is about 5 cm to about 10 cm.

82. The implantable device of claim 72, wherein the pocket portion has a width of about 8 cm to about 20 cm.

83. A method of using an implantable device, the method comprising: inserting a tether of the implantable device into a body of a subject; inserting a pocket portion of the implantable device into the body of the subject, the tether passing through a proximal end portion of the pocket portion opposite a distal end portion, the distal end portion including an opening configured to permit passage of an implantable prosthetic into the pocket portion; and applying tension to the tether to position the pocket portion along a longitudinal axis of the subject.

84. The method of claim 83, further comprising passing the tether from an external side of the pocket portion into the pocket at a first location on the pocket portion, and from within the pocket to the external side of the pocket portion at a second location on the pocket portion.

85. The method of claim 84, wherein applying tension to the tether includes applying tension to at least one of a first terminal end and a second terminal end of the tether.12845258.1WGS Ref. No.: D0188.70528WQ00- 45 -86. The method of claim 85, wherein the first terminal end is connected to a first pulley section extending from the first location on the external side of the pocket portion and the second terminal end is connected to a second pulley section extending from the second location on the external side of the pocket portion, the method further comprising passing the first and second pulley sections through tissue of the subject to form a first pulley and a second pulley, and wherein applying tension to at least one of the first terminal end and the second terminal end draws the tether through at least one of the pulleys to position the pocket portion along the longitudinal axis.

87. The method of claim 84, wherein the tether includes a first knot disposed in the pocket of the pocket portion, and a second knot disposed on the external side of the pocket portion, the method further comprising creating an anchor point in tissue of the subject by passing the tether through the tissue, and wherein applying tension to the tether comprising tightening at least one of the first knot and the second knot.

88. The method of claim 83, wherein the implantable device comprises a biocompatible prosthetic repair fabric material.

89. The method of claim 88, wherein the biocompatible prosthetic repair fabric material comprises a mesh.

90. The method of claim 89, wherein the biocompatible prosthetic repair fabric material comprises P4HB.

91. The method of claim 83, wherein the opening of the pocket portion has a width corresponding to a size of an incision through which the pocket portion is configured to be inserted.

92. The method of claim 91, wherein the width of the opening is about 12.5 cm to about17.5 cm.12845258.1WGS Ref. No.: D0188.70528WQ00- 46 -93. The method of claim 91, wherein the width of the opening is about 5 cm to about 10 cm.

94. The method of claim 83, wherein the pocket portion has a width of about 8 cm to about 20 cm.12845258.1

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