Attorney Docket No.10063-107WO1 DEVICES AND METHODS FOR BREAST TISSUE EXPANSION CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No.63/651,548, filed on May 24, 2024, the disclosure of which is expressly incorporated herein by reference in its entirety. BACKGROUND [0002] Breast tissue expansion is a common technique used for breast reconstruction. After a mastectomy, a breast tissue expander is inserted under the breast skin and secured to the chest tissue wall. Previous and current breast tissue expanders feature a few suture tabs extending from the body of the expander that are spaced circumferentially around the edge of the body of the expander for suturing the device to the chest tissue. Each of the tabs define a single suture opening for suturing the breast tissue expander to the chest wall. Once the expander is sutured into place, the breast tissue expander essentially “hangs” from the sutures, which can cause excessive strain on the portions of the chest tissue to which the device is coupled. [0003] Historically, tissue expanders for breast reconstruction featured textured surfaces that interacted with the surrounding tissue in a manner similar to a VelcroTM–like effect to hold the tissue expander in place. Because of the textured design of these previous breast tissue expanders, a minimal number of sutures were necessary, and thus provided, to secure the device in place. However, recent studies have found that the textured surfaces of the previous breast tissue expanders caused an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), leading to the recall and discontinuation of textured breast tissue expanders. [0004] To address this increased risk of breast implant-associated anaplastic large cell lymphoma, a transition to smooth surface tissue expanders was made. Because the smooth surfaces of current breast tissue expanders no longer benefit from the VelcroTM-like interaction with the surrounding tissue smooth tissue expanders have a higher risk of moving out of place in the breast, even when properly sutured. The “tear-drop” shape of expanders also causes the devices to be susceptible to rotating within the breast. [0005] Another issue with both the previous and current breast tissue expanders is the surgeon’s accessibility to the suture tabs during implantation. Current methods of mastectomy allow for smaller incisions, which leads to a less invasive procedure but provides limited access
Attorney Docket No.10063-107WO1 to the chest tissue wall for the surgeon. For example, nipple sparing mastectomies involve a small incision under the breast, that allows the surgeon to remove all of the glandular tissue from the breast. During such a surgery, one or more of the circumferentially spaced suture tabs may not be easily accessible to the surgeon. [0006] In light of these developments, there exists a pressing need for an easily accessible smooth surface breast tissue expander with a tab design that can be easily accessed while ensuring secure and effective anchoring to the chest wall. [0007] A further complication with existing breast tissue expanders is their inability to effectively manage seroma drainage around the expander during the expansion process. Typically, when a breast tissue expander is initially implanted, one or more drainage tubes are positioned in close proximity to it. Mastectomy procedures, which involve the removal of breast tissue, often result in the severance of lymphatic channels, leading to the accumulation of seroma – a fluid buildup – around the expander. While initially, this fluid can be drained via the drainage tubes, these tubes are eventually removed, leaving the expander in place. As the expansion of the expander progresses, any residual cavities in the breast surrounding the expander may become sites for seroma collection, posing a challenge in the absence of a dedicated drainage mechanism. [0008] Some current breast tissue expanders for breast reconstruction incorporate perforated drains situated at their lower (i.e. inferior) end, along with aspiration ports that function similarly to the expander's expansion ports. These features facilitate access to the drain for aspirating seroma adjacent to it. Nonetheless, these drainage systems are prone to clogging, primarily because they are positioned in the dependent part of the breast pocket. This location becomes less effective when the patient is upright, as the fluid is displaced, and the drains may not align with areas where seroma pockets are likely to form. Additionally, the design of these drains, consisting of small holes, is susceptible to tissue ingrowth, which further contributes to the risk of clogging, thereby compromising the efficiency of the drainage mechanism. Thus, there exists a need for an improved breast tissue expander capable of more effectively draining seroma in the surrounding area without becoming clogged. Additionally, there exists a further need for any such drain to be secured to the breast tissue expander in a manner that does not impede its effectiveness. This integration should facilitate efficient drainage while maintaining the structural and operational integrity of the expander. [0009] Another issue with current breast tissue expanders is the risk of unintentional fluid flow due to errant placement of a needle when attempting to access the inflation or aspiration ports. For example, this unintended flow may result in leakage of fluid from an
Attorney Docket No.10063-107WO1 interior volume of the breast tissue expander, which is undesirable. Thus, there exists a further need for a breast tissue expander that can resist leakage of fluids in the event of errant needle placement. SUMMARY [0010] In one aspect, the techniques, systems, and devices described herein relate to a breast tissue expander device. The breast tissue expander includes a body that defines an interior volume for holding an expansion fluid therein. The body further defines a convex outer surface, a base surface opposite the outer surface for placement adjacent the chest wall of a patient, and a circumferential edge along an abutment of the outer surface and the base surface. In various implementations, one or more tabs extend outwardly from the body for coupling the device to the chest wall of the patient. In various implementations, the breast tissue expander also includes an aspiration port for draining body fluid from the patient. In various implementations, the aspiration port is in fluid communication with a drain tube extending substantially around the circumferential edge of the body. In various implementations, the breast tissue expander also includes one or more retention members operatively connected to the body. In various implementations, the retention members define an aperture through which the drain tube extends to secure the drain tube to the body. [0011] In some aspects, the one or more tabs include a plurality of tabs disposed around and extending outwardly from the circumferential edge. In some aspects, the one or more tabs each define a first side, a second side opposite from the first side, and an outer edge. In some aspects, the one or more tabs are formed integrally as part of the base surface. In some aspects, the one or more tabs each define a single suture opening. [0012] In some aspects, the one or more retention members include a plurality of retention members and wherein the drain tube extends through apertures of each of the plurality of retention members. In some aspects, each of the plurality of retention members is associated with one of the tabs. In some aspects, each of the plurality of retention members are secured to one of the tabs. In some aspects, the one or more retention members each include a loop formed on one of the tabs. In some aspects, the loop is a partial loop such that a gap is formed between opposing edges of the retention member on which the loop is formed. [0013] In some aspects, the breast tissue expander further includes a drain outlet manifold operatively connected to the body and fluidically connecting the drain tube and the aspiration port. In some aspects, the drain outlet manifold is a T-shaped or Y-shaped connector
Attorney Docket No.10063-107WO1 positioned at the superior end of the body configured to fluidically couple opposing axial ends of the drain tube to the aspiration port, wherein each opposing axial end of the drain tube is coupled to a lateral portion of the drain outlet manifold and the aspiration port is coupled to a medial portion of the drain outlet manifold. In some aspects, the drain outlet manifold includes two drain outlet manifolds, wherein each drain outlet manifold fluidically connects a respective opposing axial end of the drain tube to the aspiration port. In some aspects, opposing axial ends of the drain tube are directly fluidically connected to the aspiration port. [0014] In some aspects, the body includes a superior end and an inferior end opposite the superior end, wherein a first portion of the body has a maximum thickness of the body as measured from the outer surface to the base surface, and the first portion of the body is closer to the inferior end than to the superior end. [0015] In some aspects, the body of the device further defines an expansion port for receiving the expansion fluid, the expansion port in fluid communication with an interior volume of the body, wherein the interior volume is defined between the outer surface and base surface. BRIEF DESCRIPTION OF THE DRAWINGS [0016] Example features and implementations are disclosed in the accompanying drawings. However, the present disclosure is not limited to the precise arrangements and instrumentalities shown. [0017] FIG.1 shows a top view of an example breast tissue expander device according to some implementations. [0018] FIG.2 shows a cross-sectional view of the breast tissue expander device shown in FIG.1 taken along line 2-2. [0019] FIG.3 shows a top view of an example breast tissue expander device according to some implementations. [0020] FIG.4 shows a top view of an example breast tissue expander device according to some implementations. [0021] FIG.5 shows an end view of a drain tube according to some implementations. [0022] FIG.6 shows a top view of an example breast tissue expander device according to some implementations. [0023] FIG.7 shows a top view of an example breast tissue expander device according to some implementations.
Attorney Docket No.10063-107WO1 [0024] FIG.8 shows a top view of an example breast tissue expander device according to some implementations. [0025] FIG.9 shows a perspective view of an example breast tissue expander device according to some implementations. [0026] FIG.10 shows a detailed perspective view of the example breast tissue expander device of FIG.9. [0027] FIG.11 shows a detailed wireframe perspective view of the example breast tissue expander device shown in FIG.9 taken along 11-11. [0028] FIG.12 shows a wireframe perspective view of an example breast tissue expander device. [0029] FIG.13 shows a wireframe top view of an example breast tissue expander device, according to some implementations. [0030] FIG.14 shows a side view of an example breast tissue expander device, according to some implementations. [0031] FIG.15 shows a cross-sectional wireframe side view of the example breast tissue expander device shown in FIG.14 taken along line 15-15. [0032] FIG.16 shows a cross-sectional wireframe perspective view of the example breast tissue expander device shown in FIG.14 taken along line 15-15. [0033] FIG.17 shows a detailed cross-sectional wireframe perspective view of the breast tissue expander device shown in FIG.14 taken along line 15-15. [0034] FIG.18 shows a perspective view of an example breast tissue expander device according to some implementations. [0035] FIG.19 shows a detailed perspective view of the breast tissue expander device shown in FIG.18 taken along line 19-19. [0036] FIG.20 shows a wireframe top view of an example breast tissue expander device, according to some implementations. [0037] FIG.21 shows a detailed perspective view of the example breast tissue expander device of FIG.18 taken along 21-21. [0038] FIG.22 shows a detailed side view of the example breast tissue expander device of FIG.19 taken along 22-22.
Attorney Docket No.10063-107WO1 DETAILED DESCRIPTION [0039] The devices, systems, and methods disclosed herein provide for a breast tissue expander device with a suture tab extending from the body of the device. Therefore, as used herein, the term “breast tissue” encompasses various tissues within or surrounding the breast, such as epidermal, dermal, and subcutaneous tissues, as substantial loss of breast tissue is experienced post-mastectomy. Accordingly, the devices and methods provided herein include but are not limited to devices for expanding skin and subcutaneous tissue. The tab can be elongated and extend along most of the inferior end of the body along a circumferential edge of the device. The tab of the devices disclosed herein define a plurality of suture openings aligned parallel to the inferior end of the body such that a surgeon can tie a suture in a baseball stitch through the openings to couple the tab of the device to the inframammary area of the patient. Importantly, a typical incision for implanting tissue expander devices is made in the inframammary area, which makes the placement of the tab in this location particularly advantageous. It offers easier exposure and accessibility for the surgeon during the suturing process. The strategic positioning of the tab along the inferior end of the device's body is instrumental in creating a supportive “shelf”. This design allows for the support of the device’s body from beneath through the attached tab. Conversely, existing tissue expanders suspend the expander from suture tabs located at the superior end or the sides of the device. This advancement in breast tissue expander design significantly improves the stability and positioning of the device within the patient's breast pocket. [0040] The devices, systems, and methods disclosed herein further provide for a breast tissue expander device with one or more suture tabs coupled at any location and each defining two or more suture openings. [0041] The devices, systems, and methods disclosed herein further provide for a breast tissue expander device with an integrated drain tube that extends around the circumferential edge of the expander. Because the drain extends around the circumferential edge of the expander, rather than only the inferior end as with some current expanders, the drain is able to access seroma pockets at any location around the expander throughout the entire expansion process. As seroma forms in the breast, the expander can displace any seroma that has accumulated in the inferior portion of the breast, causing the seroma to migrate superiorly. Also, pockets of seroma (e.g., body fluid) can form and become trapped in other locations around the expander other than the inferior portion of the breast. The circumferentially extending integrated drain tubes disclosed in the devices, systems, and methods herein are able to access this body fluid such that
Attorney Docket No.10063-107WO1 the body fluid can be aspirated through an integrated port of the expander, thereby addressing a critical need in post-mastectomy breast reconstruction for effective fluid management around the device. [0042] Furthermore, the drain tubes disclosed in some implementations are Blake drains that define a series of axially extending channels spaced apart from each other circumferentially. These channels provide more opening area than the perforated drains of existing expanders to prevent clogging of the openings. Also, with current expander drains located at the inferior end of the expander, the weight of the expander causes the inferior end of the expander to press against the tissue at the inferior end of the breast, clogging the drain openings. Because the drain tubes disclosed herein are extending along the circumferential edge of the expanders, the abutment of the expander against the inferior tissue of the breast does not block the only openings of the drain tube. [0043] The drain tubes are fluidically coupled to an aspiration port that can be accessed through the overlying tissue of the breast by piercing the tissue and port with a syringe needle. The syringe can then be used to cause a suction force to extract the seroma through the drain tube, through the aspiration port, and into the syringe. [0044] FIGS.1-4 show breast tissue expander devices 100, 200, 300, according to various aspects. The devices 100, 200, 300 each include a body 110, 210, 310, at least one tab 140, 240, 340, and a drain tube 170, 270, 370. [0045] FIGS.1 and 2 show a first implementation of a breast tissue expander device 100. The body 110 of the device 100 shown in FIGS.1 and 2 has a first surface 112 and a second surface 114 opposite the first surface 112. The first surface 112 defines a convex surface configured to face away from a patient, and the second surface 114 is configured to abut the chest tissue of the patient. The first surface 112 and the second surface 114 of the body 110 defines an interior volume 116 that can be filled with an expansion fluid (e.g., sterile saltwater) to cause expansion of the body 110. The body 110 (i.e., first surface 112 and second surface 114) is a smooth surface tissue expander (STE). [0046] The first surface 112 of the body 110 defines an expansion port 118. The expansion port 118 can be accessed using a syringe and needle, or any other pumping device, that can cause an expansion fluid to flow into the interior volume 116 of the body 110 to expand the body 110. Although the expansion port 118 shown in FIG.1 is an integrated port disposed within the interior volume 116 and is accessible along the first surface 112, in some implementations, the expansion port is a top port disposed external to the first surface.
Attorney Docket No.10063-107WO1 [0047] The body 110 further has a circumferential edge 120 defined along an abutment of the first surface 112 and the second surface 114, a superior end 122, and an inferior end 124 opposite the superior end 122. The body 110 is a “teardrop” shape such that a portion of the body 110 that is closer to the inferior end 124 than to the superior end 122 has the maximum thickness 126 of the body 110 as measured from the first surface 112 to the second surface 114. The inferior end 124 of the body 110 includes an inframammary portion 128 configured to be located adjacent the inframammary area of the patient when the device 100 is coupled to the chest of the patient. The body 110 of the device 100 can be sized according to the desired expansion of the tissue. [0048] The body 110 of the device 100 shown in FIGS.1 and 2 is made of silicone, but in other implementations, the body can be made of any other material suitable for implantation in the body of a patient. [0049] The device 100 shown in FIGS.1 and 2 includes a single tab 140 used for coupling the device 100 to the chest of a patient. The tab 140 extends outwardly from the body 110 and has a first side 142, a second side 144 opposite from the first side 142, a first edge 146 extending from the first side 142 to the second side 144, and a second edge 148 opposite from the first edge 146. The first edge 146 of the tab 140 is coupled to the body 110 along the inferior end 124 of the body 110. The tab 140 shown in FIGS.1 and 2 is coupled to the body 110 of the device 100 by being integrally formed with the body 110, but in other implementations, the tab is separately formed from the body of the device and is coupled by known means to the body. The tab 140 shown in FIGS.1 and 2 is made of the same material as the body 110, but in implementations in which the tab is a separately formed from the body and coupled to the body, the tab can be made of silicone or any other material suitable for implantation in the body of a patient. [0050] The tab 140 shown in FIGS.1 and 2 is coupled to the circumferential edge 120 of the body 110 along the inferior end 124. The tab 140 defines a total of twenty suture openings 150 extending from the first side 142 of the tab 140 to the second side 144 of the tab 140. The tab 140 shown in FIGS.1 and 2 extends along 75% of the inferior end 124 of the body 110, but in other implementations, the tab extends more or less than 75% of the inferior end of the body. In some implementations, the tab extends along 70mm-100mm of the inferior end of the body, depending on the size and shape of the body. The location of the tab 140 along the inferior end 124 of the body 110 allows the body 110 to be attached to the inframammary area of the patient. The inframammary area, such as the inframammary ridge, contains enough tissue to provide a
Attorney Docket No.10063-107WO1 secure coupling point for the device 100 and allows the device 100 to naturally rest on the inframammary area. [0051] Each of the suture openings 150 shown in FIGS.1 and 2 is spaced 5mm apart from the adjacent suture openings 150 and/or the edges of the tab 140. The spacing of the suture openings 150 provide enough attachment points for a surgeon to tie a baseball stitch suture along each tab 140 to securely couple the tab 140 to the chest tissue of a patient. However, in some implementations, each suture opening is spaced apart from the adjacent suture openings and/or the edges of the tab by 4mm-6mm. In some implementations, each suture opening is spaced apart from the adjacent suture openings and/or the edges of the tab by 2mm-10mm. [0052] Although the tab 140 shown in FIGS.1 and 2 defines a total of twenty suture openings 150, in other implementations, the tab defines any number of two or more suture openings extending from the first side to the second side of the tab. In some implementations, the two or more suture openings includes four or more suture openings to provide enough attachment points to securely couple the device to the chest tissue of a patient. [0053] In some implementations, such as the implementation shown in FIG.3, the device 200 includes two tabs 240 coupled to the inferior end 224 of the body 210. The device 200 shown in FIG.3 is similar to the device 100 shown in FIGS.1 and 2, so reference numbers are used in FIG.3 that are similar to those used in FIGS.1 and 2 to describe similar features. Each of the tabs 240 includes nine suture openings 250 to provide for a total of twenty suture openings 250, similar to the device 100 shown in FIGS.1 and 2. Although the implementation of the device 200 shown in FIG.3 includes two tabs 240, in other implementations, the device can include any number of tabs coupled to the inferior edge and each of the tabs can include any number of openings. For example, in some implementations, the device could include Y number of tabs coupled to the inferior end of the body, and each tab could define Z suture openings such that the Y number of tabs define a total of YxZ suture openings. In some implementations, the device can further include any number of tabs coupled to any other portion of the body as long as at least one tab is coupled to the inferior edge of the body and the at least one tab defines a total of 2 suture openings. [0054] The drain 170 shown in FIGS.1 and 2 is a Blake drain defining four channels 172 or grooves extending longitudinally along the drain 170. Each of the four channels 172 is spaced apart circumferentially from the other channels by 90 degrees. The drain 170 allows seroma accumulating around the device 100 to be evacuated using a suction source. The drain tube 170 includes a center line 174 extending along its longitudinal axes. The center line 174 of the drain
Attorney Docket No.10063-107WO1 tube 170 shown in FIGS.1 and 2 extends around, and substantially parallel to, the entire circumferential edge 120 of the body 110, but in other implementations, the center line of the drain tube extends at least 75% of the circumferential edge. In some implementations, the center line of the drain tube extends around at least 50% of the circumferential edge. In some implementations, the center line of the drain tube along at least the inferior end of the body. [0055] The drain tube 170 shown in FIGS.1 and 2 is a Blake drain, but in other implementations, the drain tube can be any other type of drain known in the art. For example, FIG.7 shows a device 600 that includes a solid tube drain 670, and FIG.8 shows a device 700 that includes a perforated tube drain 770. [0056] The axial ends of the drain tube 170 form drain outlets 178. As shown in FIG.1, the drain outlets are coupled to a Y-connector such that the drain tube 170 is in fluid communication with an aspiration port 176. The aspiration port 176 can be accessed using a syringe and needle, or any other suction device, that can cause a negative pressure within the drain tube 170 to cause the seroma accumulated around the device 100 to flow through the channels 172 of the drain tube 170, through the aspiration port 176, and out of the breast. Although the aspiration port 176 shown in FIG.1 is an integrated port disposed within the interior volume 116 and is accessible along the first surface 112, in some implementations, the aspiration port is a top port disposed external to the first surface. [0057] It is also contemplated that the drain tube 170, or any other drain tubes disclosed herein, could be used for injecting treatment such as chemotherapy or antibiotics in addition to or in replacement of evacuation of seroma. [0058] The drain tube 170 shown in FIGS.1 and 2 extends along the inframammary portion 128 of the body 110 such that the tab 140 is coupled to a portion of the body 110 that is closer than the drain tube 170 to the circumferential edge 120. Thus, the tab 140 can be coupled to the chest tissue of a patient by sutures such that the tab 140 is flat against the chest tissue and the drain 170 extends over the tab 140. The second edge 148 of the tab 140 can extend beyond the drain tube 170 by at least 10mm. [0059] FIG.4 shows another breast tissue expander device 300, according to another implementation. The device 300 shown in FIG.4 is similar to the device 100 shown in FIGS.1 and 2, so reference numbers are used in FIG.4 that are similar to those used in FIGS.1 and 2 to describe similar features. The device 300 shown in FIG.4 has a body 310 similar to the device 100 shown in FIGS.1-3. However, the tabs 340 of the device 300 shown in FIG.4 are not
Attorney Docket No.10063-107WO1 coupled to the inferior end 324 of the body 310. Instead, the tabs 340 are coupled to the body 310 such that the tabs 340 are spaced around the circumferential edge 320. [0060] Each of the tabs 340 includes two or more suture openings 350. The two or more suture openings 350 of the tabs 340 of the device 300 shown in FIG.4 provide enough attachment points for a surgeon to tie a baseball stitch suture along each tab 340 to securely couple each of the tabs 340 to the chest tissue of a patient. [0061] The device 300 shown in FIG.4 includes five tabs 340, but in other implementations, the device can include any number of tabs. In some implementations, each tab can include any number of suture openings, as long as at least one of the tabs defines two or more suture openings. The tabs 340 shown in FIG.4 are spaced around the circumferential edge 320 of the body 310, but in other implementations, the tabs are coupled to the body at strategic locations to provide more secure coupling points of the device to the chest tissue of a patient. In some implementations, at least one of the tabs is located along the inferior end of the body of the device. [0062] FIG.5 shows another implementation of a drain tube 470. The drain tube shown in FIG.5 is a Blake drain similar to the drain tube 170 shown in FIGS.1 and 2. However, the drain tube 470 shown in FIG.5 includes one or more tabs 440 defining one or more suture openings 450 and one or more coupling flanges 471. The one or more coupling flanges 471 can be coupled to a body of a device to secure the drain tube 470 to the body. Once the coupling flanges are coupled to the body of a device, the one or more tabs 440 can be used to couple the device to the chest tissue of a patient. Although the present application is directed to breast tissue expander devices, it is contemplated that the drain tube 470 shown in FIG.5 could be used with any implantable device. [0063] The one or more tabs 440 extend radially outwardly from an outer surface of the drain tube 470. The one or more coupling flanges 471 extend radially outwardly from the outer surface of the drain tube 470 such that the one or more coupling flanges 471 are diametrically opposed from the one or more tabs 440. However, in some implementations, the one or more coupling flanges 471 extend radially outwardly from the outer surface of the drain tube 470 such that the one or more coupling flanges 471 are transverse to the one or more tabs 440. [0064] The one or more tabs 440 can be axially spaced apart from the one or more coupling flanges 471, or one or more of the tabs 440 can be disposed directing across the center line 474 from one of the coupling flanges 471.
Attorney Docket No.10063-107WO1 [0065] FIG.6 shows another breast tissue expander device 500, according to another implementation. The device 500 shown in FIG.6 is similar to the device 100 shown in FIGS.1 and 2, so reference numbers are used in FIG.6 that are similar to those used in FIGS.1 and 2 to describe similar features. The device 500 shown in FIG.6 has a body 510 similar to the device 100 shown in FIGS.1-4. However, the device 500 shown in FIG.6 includes an elongated tab 540 coupled to the inferior end 524 of the body 510, similar to the device 100 shown in FIGS.1 and 2, and five tabs 541 are coupled to the body 510 such that the tabs 541 are spaced around the circumferential edge 520. [0066] Each of the tabs 541 includes one or more suture openings 551. The suture openings 551 of the elongated tab 540 can be used to anchor the device to the chest tissue of the patient to form a supporting “shelf,” similar to the device 100 shown in FIGS.1 and 2, while the suture openings 551 of the tabs 541 can be used to keep the device 500 in the correct orientation. [0067] Although the tab 540 of the device shown in FIG.6 includes twenty suture openings 550, as with the device 100 of FIGS.1 and 2, in some implementations, the device can include any number of suture openings located at any spacing relative to each other or relative to the ends of the tab. In some implementations, the device includes two or more tabs coupled to the inferior end, similar to the device 200 shown in FIG.3, along with the tabs spaced around the circumferential edge. [0068] The device 500 shown in FIG.6 includes five tabs 541, but in other implementations, the device can include any number of tabs. In some implementations, each tab can include any number of suture openings. The tabs 541 shown in FIG.6 are spaced around the circumferential edge 520 of the body 510, but in other implementations, the tabs are coupled to the body at strategic locations to provide more secure coupling points of the device to the chest tissue of a patient. [0069] FIGS.9-17 show a breast tissue expander device 800 according to another implementation. The device 800 shown in FIG.9 is similar to the device 100 shown in FIGS.1 and 2, so reference numbers are used in FIG.6 that are similar to those used in FIGS.1 and 2 to describe similar features. As shown in FIG.9, the breast tissue expander device 800 includes a body 810 (e.g., a smooth tissue expander (STE)) defining an interior volume 816 that can be filled with an expansion fluid (e.g., sterile saltwater) to cause expansion of the body 810. The body 810 defines a convex outer surface 812 (configured in the illustrated implementation as a convex surface configured to face away from a patient) and a base surface 814 (configured in the illustrated implementation as a substantially flat surface to abut the chest tissue of the patient).
Attorney Docket No.10063-107WO1 The body 810 also defines a circumferential edge 820 along an abutment of the convex outer surface 812 and the base surface 814. As will be appreciated from the description herein, the body 810 may be constructed from silicone or other materials suitable for implantation in the body of a patient. [0070] In the illustrated implementation, the body 810 has a teardrop shape defining a superior end 822 and an inferior end 824. A portion of the body 810 that is closer to the inferior end 824 than to the superior end 822 defines a maximum thickness 826 of the body 810 (e.g., as measured from the convex outer surface 812 to the base surface 814). As will be appreciated from the description herein, the body 810 of the device 800 can be sized according to the desired expansion of the tissue. [0071] As shown in FIGS.12, 13, 15, and 16, the body 810 includes an expansion port 818 configured to be accessed using a syringe and needle (or other suitable pumping device) for receiving an expansion fluid into the interior volume 816 of the body 810 (i.e., to expand the body 810). In the illustrated implementation, the expansion port 818 is disposed within the interior volume 816 of the body 810 and is accessible through the convex outer surface 812. [0072] The device 800 also includes a drain tube 870 that allows seroma accumulating around the device 800 to be evacuated using a suction source. As shown in FIGS.9, 12, and 13, the drain tube 870 extends around the circumferential edge 820 of the body 810. In various implementations, the drain tube 870 is a Blake drain defining a series of axially extending channels spaced apart from each other circumferentially. For example, the drain tube 870 itself may have the configuration of the above-described drain tube 870 (e.g., having four channels or grooves extending longitudinally along the drain 870). In various implementations, the drain tube 870 may be a solid drain tube or a perforated drain tube. As the drain tube 870 extends along the circumferential edge 820, the abutment of the device 800 against the inferior tissue of the breast does not block the openings of the drain tube 870 and the drain tube 870 is able to access seroma pockets at any location around the expander throughout the entire expansion process. [0073] The drain tube 870 is fluidically coupled to an aspiration port 876. In the illustrated implementation, the aspiration port 876 is disposed within the interior volume 816 of the body 810 and is accessible through the convex outer surface 812. In various implementations, the aspiration port 876 can be accessed through the overlying tissue of the breast by piercing the tissue and port with a syringe needle. The syringe can then be used to cause a suction force to extract the seroma through the drain tube 870, through the aspiration port
Attorney Docket No.10063-107WO1 876, and into the syringe. In other words, the aspiration port 876 can be used to cause a negative pressure within the drain tube 870 to cause the seroma accumulated around the device 800 to flow through the channels of the drain tube 870, through the aspiration port 876, and out of the breast. Furthermore, as noted above, it is also contemplated that the drain tube 870, or any other drain tubes disclosed herein, could be used for injecting treatment such as chemotherapy or antibiotics in addition to or in replacement of evacuation of seroma. [0074] The opposing axial ends 871 of the drain tube 870 are coupled to a drain outlet manifold 878 that allows the drain tube 870 to be fluid communication with the aspiration port 876. In the illustrated implementation of FIGS.9-17, the drain outlet manifold 878 is a T-shaped connector positioned at the superior end 822 of the body 810. The drain outlet manifold 878 fluidically couples the aspiration port 876 to the opposing axial ends 871 of the drain tube 870 (e.g., such that each opposing axial end 871 of the drain tube 870 is coupled to a lateral portion of the drain outlet manifold 878 and the aspiration port 876 is coupled to a medial portion of the drain outlet manifold 878). In other implementations, the drain outlet manifold 878 may be, for example, a Y-shaped connector. In other implementations, the opposing axial ends 871 of the drain tube 870 may be secured to individual drain outlet manifolds 878, where each drain outlet manifold 878 is in fluid communication with the aspiration port 876. [0075] To facilitate attachment of the breast tissue expander device 800 to the patient, the device includes a one or more tabs 840. In the illustrated implementation, the tabs 840 extend from and are formed integrally with the base surface 814 of the body 810. In other words, the plurality of tabs 840 are formed from the same material as the base surface 814 of the body 810. However, in other implementations, the tabs 840 may be formed separately and coupled to the body 810 (e.g., adhered to the body 810 proximate to the circumferential edge 820). [0076] In various implementations, the device 800 includes a plurality of tabs 840. For example, in the illustrated implementation of FIGS.9-17, the device 800 includes six tabs 840. Each of the tabs 840 extends outwardly from the body’s circumferential edge 820 (e.g., such that the tabs 840 extend outwardly from and are substantially parallel to the body’s base surface 814). Furthermore, as shown for example in FIG.13, the plurality tabs 840 are spaced around the circumferential edge 820 of the body 810 (including at the superior end 822 and the inferior end 824 of the body 810). [0077] In the illustrated implementation, each of the tabs 840 defines a first side 842, a second side 844 opposite from the first side 842, and an outer edge 848. In the illustrated implementation of FIGS.9-17, each tab 840 is integrally formed with the body 810. However, in
Attorney Docket No.10063-107WO1 implementations where the tabs 840 are formed separately and coupled to the body 810, each tab 840 may further define an interior edge along which the respective tab 840 is adhered to the body 810 (e.g., along the circumferential edge 820 of the body 810). [0078] In various implementations, each tab 840 defines at least one suture opening 850. In the illustrated implementation of FIGS.9-17, each of the plurality of tabs 840 defines a single suture opening 850. The suture openings 850 of the tabs 840 can be used to anchor the device 800 to the chest tissue of the patient and keep the device 800 in the correct orientation. In other implementations, each tab 840 can include multiple suture openings 850 (e.g., two or more suture openings). [0079] The device 800 also includes one or more retention members 880 operatively connected to the body 810 and configured for securing a drain tube 870 to the body 810. In the illustrated implementation, a plurality of retention members 880 are disposed around the body 810. As shown in FIGS.10 and 11, for example, each respective retention member 880 defines an aperture 885 through which the drain tube 870 extends, thereby securing the drain tube 870 to the body 810. In various implementations, the number of retention members 880 may be selected to safely and securely retain the drain tube 870 to the body 810. [0080] In the illustrated implementation, the plurality of retention members 880 each define a hollow cylindrical body (e.g., a closed loop) oriented horizontally with respect to the drain tube 870 (e.g., such that the drain tube 870 extends through the hollow cylindrical body). In other implementations, the retention members 880 may be openable (e.g., defining a partial loop so that a gap is formed between opposing edges of the cylindrical body of the at least one retention member 880). In such implementations, each retention member 880 may be resiliently flexed so as to receive and retain the drain tube 870. In other implementations, the retention members 880 may be hinged so as to pivot from a closed configuration to an open configuration. In such implementations, the retention members 880 may be moved from the closed configuration to an open configuration to receive the drain tube 870 and then moved from the open configuration to the closed configuration to secure the drain tube 870 to the body 810. [0081] In various implementations, each of the plurality of retention members 880 may be secured to a respective tab 840. In this way, the tabs 840 are configured to both (i) facilitate attachment of the device 800 to the patient and (ii) facilitate securing of the drain tube 870 to the body 810 via the retention members 880. For example, in the illustrated implementation of FIGS.9-17, each respective retention member 880 is formed integrally with a respective tab 840 (e.g., such that each retention member 880 and tab 840 may be formed from the same material,
Attorney Docket No.10063-107WO1 such as in a mold). In other implementations, each retention member 880 may be formed separately and adhered to a respective tab 840 (e.g., by chemical or physical bonding). For instance, a respective retention member 880 may be chemically coupled to a respective tab 840 using an adhesive or be physically coupled to the respective tab 840 through thermal molding. [0082] As shown in FIGS.12 and 13, each of the plurality of tabs 840 is paired with a single retention member 880. However, in other implementations, only some of the tabs 840 may be paired with a retention member 880 or tabs 840 may be provided with more than one retention member 880. [0083] In various other implementations, the plurality of retention members 880 may be coupled directedly to the body 810. For example, in some implementations, the retention members 880 may be formed integrally with (or attached to) the body’s convex outer surface 812, base surface 814, or the circumferential edge 820. In one implementation, each retention member 880 is formed integrally with and formed from the same material as the body’s base surface 814. In some implementations, each retention member 880 is formed separately and is then coupled to the convex outer surface 812, base surface 814, or circumferential edge 820 (e.g., by chemical or physical bonding). In such implementations, the retention members 880 may be coupled to the body 810 in locations substantially aligned with the tabs 840 or in locations between tabs 840. [0084] The device 800 further includes a plurality of flow barriers to prevent inadvertent leakage of fluid from the device 800 in the event that needles or other sharps are misplaced relative to the expansion port 818 and/or aspiration port 876. As discussed above, in the illustrated implementation, the expansion port 818 and the aspiration port 876 are disposed within the interior volume 816 of the body 810 and are accessible through the convex outer surface 812. Accordingly, the device 800 includes a first flow barrier 882, a second flow barrier 884, and a third flow barrier 886 arranged proximate to the ports 818, 876. In various implementations, the flow barriers 882, 884, and 886 may be formed from a different material than the body’s convex outer surface 812. Specifically, in the implementation shown in FIG.15, the flow barriers 882, 884, and 886 are each formed of a self-healing silicone material. However, in other implementations, the convex outer surface 812 and the flow barriers 882, 884, 886 may be formed out of the same material. In yet further implementations, one or more of the flow barriers 882, 884, 886 may be formed as a single contiguous component. [0085] Each of the flow barriers 882, 884, 886 are generally shaped such that its outer surface forms a consistent contour along the superior portion of the body 810 (e.g., such that the
Attorney Docket No.10063-107WO1 outer surfaces of the flow barriers 882, 884, 886 are substantially flush and aligned with the convex outer surface 812 of the body 810 and the other flow barriers 882, 884, 886 so that the presence of the flow barriers is substantially non-perceptible from touching the outer surface of the device 800 ). In some implementations, all or part of the outer surfaces of the flow barriers 882, 884, 886 define an exterior surface of the body 810. [0086] In various implementations, the flow barriers 882, 884, 886 further define recesses for receiving and surrounding the expansion port 818 and the aspiration port 876. In some implementations, one or more of the flow barriers 882, 884, 886 substantially encase one or both of the expansion port 818 and the aspiration port 876. In this way, the flow barriers 882, 884, 886 are positioned to prevent the inadvertent puncture of the body 810 in areas surrounding the ports 818, 876. Accordingly, the flow barriers 882, 884, 886 assist in preventing the exit of expansion fluid contained within interior volume 816 or seroma contained within the aspiration port 876 into the patient’s body. [0087] In use, a needle may be used to puncture one or more of the flow barriers 882, 884, 886 to access the expansion port 818 or aspiration port 876. [0088] In the illustrated implementation, the second flow barrier 884 is disposed over and around the expansion port 818. In particular, the second flow barrier 884 is positioned over the expansion port 818 within a recess of the first flow barrier 882 and defines an exterior surface of the body 810. The third flow barrier 886 is disposed such that it immediately encases the aspiration port 876 and is positioned within a recess of the first flow barrier 882. [0089] In various implementations, the second flow barrier 884 and the third flow barrier 886 may be formed of a material with a higher density than the first flow barrier 882. In this way, an electronic sensor configured to detect changes in capacitance generated by the density differences between the flow barriers may be used to locate the expansion port 818 and aspiration port 876. In other implementations, each of the flow barriers 882, 884, 886 may be formed of materials having different densities. Thus, in addition to the protective functionality provided by the flow barriers 882, 884, 886, the flow barriers offer enhanced ability to locate the ports 818, 876 using non-magnetic techniques. This allows the breast tissue expander device 800 to avoid interfering with a variety of patient medical procedures, such as MRIs. [0090] In various other implementations, the device 800 may include any combination of one or more of the first flow barrier 882, the second flow barrier 884, and the third flow barrier 886.
Attorney Docket No.10063-107WO1 [0091] FIGS.18-22 shows a breast tissue expander device 900 according to another implementation. The device 900 shown in FIG.18 is similar to the device 800 shown in FIGS.9-17. Accordingly, like reference numbers are used to refer to like features. [0092] As shown in FIG.18, the breast tissue expander device 900 includes a body 910 (e.g., a smooth tissue expander (STE)) defining an interior volume 916 that can be filled with an expansion fluid (e.g., sterile saltwater) to cause expansion of the body 910. The body 910 defines a convex outer surface 912 (configured in the illustrated implementation as a convex surface configured to face away from a patient) and a base surface 914 (configured in the illustrated implementation as a substantially flat surface to abut the chest tissue of the patient). The body 910 also defines a circumferential edge 920 along an abutment of the convex outer surface 912 and the base surface 914. As will be appreciated from the description herein, the body 910 may be constructed from silicone or other materials suitable for implantation in the body of a patient. [0093] In the illustrated implementation, the body 910 has a teardrop shape defining a superior end 922 and an inferior end 924. A portion of the body 910 that is closer to the inferior end 924 than to the superior end 922 defines a maximum thickness 926 of the body 910 (e.g., as measured from the convex outer surface 912 to the base surface 914). As will be appreciated from the description herein, the body 910 of the device 900 can be sized according to the desired expansion of the tissue. [0094] As shown in FIG.20, the body 910 includes an expansion port 918 configured to be accessed using a syringe and needle (or other suitable pumping device) for receiving an expansion fluid into the interior volume 916 of the body 910 (i.e., to expand the body 910). In the illustrated implementation, the expansion port 918 is disposed within the interior volume 916 of the body 910 and is accessible through the convex outer surface 912. [0095] The device 900 also includes a drain tube 970 that allows seroma accumulating around the device 900 to be evacuated using a suction source. As shown in FIGS.18-22, the drain tube 970 extends around the circumferential edge 920 of the body 910. As shown for example in FIGS.21-22, the drain tube 970 is a Blake drain defining a series of axially extending channels spaced apart from each other circumferentially. In the illustrated implementation, the drain tube 970 itself has four channels or grooves extending longitudinally along the drain 970. In various implementations, the drain tube 970 may be a solid drain tube or a perforated drain tube. As the drain tube 970 extends along the circumferential edge 920, the abutment of the device 900 against the inferior tissue of the breast does not block the openings of the drain tube
Attorney Docket No.10063-107WO1 970 and the drain tube 970 is able to access seroma pockets at any location around the expander throughout the entire expansion process. [0096] The drain tube 970 is fluidically coupled to an aspiration port 976, which is configured differently compared to the aspiration port 976 of device 900 in that opposing axial ends 971 of the drain tube 970 are in direct fluid communication with the aspiration port 976. In particular, the aspiration port 976 is depicted in FIGS.18-19 but is obscured by the third flow barrier 986. As shown for example in FIG.19, the two opposing axial ends 971 extend directly into two respective drain outlet openings 979 defined in the aspiration port 976 at the superior end 922 of the body 910. In other implementations, the opposing axial ends 971 of the drain tube 970 may be coupled to a drain outlet manifold 978 that fluidically couples the opposing ends 971 of the drain tube 970 to the aspiration port 976 (e.g., such that each opposing axial end 971 of the drain tube 970 is coupled to a lateral portion of the drain outlet manifold 978 and the aspiration port 976 is coupled to a medial portion of the drain outlet manifold 978). In some implementations, the drain outlet manifold 978 may be, for example, a Y-shaped connector. In other implementations, the opposing axial ends 971 of the drain tube 970 may be secured to individual drain outlet manifolds 978, where each drain outlet manifold 978 is in fluid communication with the aspiration port 976. [0097] In the illustrated implementation, the aspiration port 976 is disposed within the interior volume 916 of the body 910 and is accessible through the convex outer surface 912. In various implementations, the aspiration port 976 can be accessed through the overlying tissue of the breast by piercing the tissue and port with a syringe needle. The syringe can then be used to cause a suction force to extract the seroma through the drain tube 970, through the aspiration port 976, and into the syringe. In other words, the aspiration port 976 can be used to cause a negative pressure within the drain tube 970 to cause the seroma accumulated around the device 900 to flow through the channels of the drain tube 970, through the aspiration port 976, and out of the breast. Furthermore, as noted above, it is also contemplated that the drain tube 970, or any other drain tubes disclosed herein, could be used for injecting treatment such as chemotherapy or antibiotics in addition to or in replacement of evacuation of seroma. [0098] The device 900 illustrated in the implementation of FIGS.18-22 has tabs 940 similar to the device 800 shown in FIGS.9-17 to facilitate attachment of the breast tissue expander device 900 to the patient. In the illustrated implementation, the tabs 940 extend from and are formed integrally with the base surface 914 of the body 910. In other words, the plurality of tabs 940 are formed from the same material as the base surface 914 of the body 910.
Attorney Docket No.10063-107WO1 However, in other implementations, the tabs 940 may be formed separately and coupled to the body 910 (e.g., adhered to the body 910 proximate to the circumferential edge 920). [0099] In various implementations, the device 900 includes a plurality of tabs 940. For example, in the illustrated implementation of FIGS.18-22, the device 900 includes six tabs 940. Each of the tabs 940 extends outwardly from the body’s circumferential edge 920 (e.g., such that the tabs 940 extend outwardly from and are substantially parallel to the body’s base surface 914). Furthermore, as shown for example in FIG.20, the plurality tabs 940 are spaced around the circumferential edge 920 of the body 910 (including at the superior end 922 and the inferior end 924 of the body 910). [00100] In the illustrated implementation, each of the tabs 940 defines a first side 942, a second side 944 opposite from the first side 942, and an outer edge 948. In the illustrated implementation of FIGS.18-22, each tab 940 is integrally formed with the body 910. However, in implementations where the tabs 940 are formed separately and coupled to the body 910, each tab 940 may further define an interior edge along which the respective tab 940 is adhered to the body 910 (e.g., along the circumferential edge 920 of the body 910). [00101] However, as shown for example in FIG.20, the tabs 940 are configured differently compared to the tabs 840 in that only a tab 940 positioned at the superior end 922 defines a suture opening 950 that can be used to anchor the device 900 to the chest tissue of the patient and keep the device 900 in the correct orientation. As shown for example in FIG.19, the tab 940 positioned at the superior end 922 defines a single suture opening 950. In other implementations, one or more additional tabs 940 may define at least one suture opening 950. As shown in FIG.21, the other tabs 940 spaced around the circumferential edge 920 of the body 910 (including at the inferior end 924) do not contain a suture opening 950. These tabs may be secured to the chest tissue of the patient by puncturing the tbs 940 with a suture. [00102] The device 900 illustrated in the implementation of FIGS.18-22 has retention members 980 similar to the device 800 shown in FIGS.9-17. As provided herein, the retention members 980 are operatively connected to the body 910 and are configured for securing a drain tube 970 to the body 910. In the illustrated implementations, a plurality of retention members 980 are disposed around the body 910. As shown for example in FIGS.19 and 21, each respective retention member 980 defines an aperture 985 through which the drain tube 970 extends, thereby securing the drain tube 970 to the body 910. In various implementations, the number of retention members 980 may be selected to safely and securely retain the drain tube 970 to the body 910.
Attorney Docket No.10063-107WO1 [00103] In the illustrated implementation, the plurality of retention members 980 each define a hollow cylindrical body (e.g., a closed loop) such that the drain tube 970 extends through the hollow cylindrical body. In other implementations, the retention members 980 may be openable (e.g., defining a partial loop so that a gap is formed between opposing edges of the cylindrical body of the at least one retention member 980). In such implementations, each retention member 980 may be resiliently flexed so as to receive and retain the drain tube 970. In other implementations, the retention members 980 may be hinged so as to pivot from a closed configuration to an open configuration. In such implementations, the retention members 980 may be moved from the closed configuration to an open configuration to receive the drain tube 970 and then moved from the open configuration to the closed configuration to secure the drain tube 970 to the body 910. [00104] In various implementations, each of the plurality of retention members 980 may be secured to a respective tab 940. In this way, the tabs 940 are configured to both (i) facilitate attachment of the device 900 to the patient and (ii) facilitate securing of the drain tube 970 to the body 910 via the retention members 980. For example, in the illustrated implementation of FIGS.18-22, each respective retention member 980 is formed integrally with a respective tab 940 (e.g., such that each retention member 980 and tab 940 may be formed from the same material, such as in a mold). In other implementations, each retention member 980 may be formed separately and adhered to a respective tab 940 (e.g., by chemical or physical bonding). For instance, a respective retention member 980 may be chemically coupled to a respective tab 940 using an adhesive or be physically coupled to the respective tab 940 through thermal molding. [00105] However, the retention members 980 shown in FIGS.18-24 are configured differently compared to the retention members 880 shown in FIGS.9-17 in that some tabs 940 are paired with a single retention member 980 while one tab 940 is paired with more than one retention member 980. Specifically, in the illustrated implementation, five tabs 940 are paired with a single retention member 980, and one tab 940 positioned at the superior end 922 is paired with two retention members 980. As shown for example in FIG.19, tabs 940 spaced around the circumferential edge 920 of the body 910 (including at the inferior end 924) are paired with only a single retention member 980 each. However, as shown for example in FIG.19, the tab 940 positioned at the superior end 922 is paired with two retention members 980 that extend obliquely from the tab 940 so as to match respective curvatures of the drain tube 970 adjacent where the opposing axial ends 971 drain tube 970 enter the drain outlet opening 979 defined in
Attorney Docket No.10063-107WO1 the aspiration port 976. As shown, the opposing axial ends 971 pass through apertures 985 defined by the two retention members 980. In the implementation shown, for example in FIG.22, the two retention members 980 define partial loops so that gaps are formed between opposing edges of the cylindrical bodies of the respective retention member 980 positioned at the superior end 922. Furthermore, the two retention members 980 shown at the superior end 922 are resiliently flexible so as to receive respective opposing axial ends 971 of the drain tube 970 between the gap and the base surface 914 and/or tab 940 and retain the drain tube 970 within the apertures 985 of the two retention members 980. [00106] In various other implementations, the plurality of retention members 980 may be coupled directedly to the body 910. For example, in some implementations, the retention members 980 may be formed integrally with (or attached to) the body’s convex outer surface 912, base surface 914, or the circumferential edge 920. In one implementation, each retention member 980 is formed integrally with and formed from the same material as the body’s base surface 914. In some implementations, each retention member 980 is formed separately and is then coupled to the convex outer surface 912, base surface 914, or circumferential edge 920 (e.g., by chemical or physical bonding). In such implementations, the retention members 980 may be coupled to the body 910 in locations substantially aligned with the tabs 940 or in locations between tabs 940. [00107] The device 900 further includes a plurality of flow barriers to prevent inadvertent leakage of fluid from the device 900 in the event that needles or other sharps are misplaced relative to the expansion port 918 and/or aspiration port 976. As discussed above, in the illustrated implementation, the expansion port 918 and the aspiration port 976 are disposed within the interior volume 916 of the body 910 and are accessible through the convex outer surface 912. Accordingly, the device 900 includes a first flow barrier 982, a second flow barrier 984, and a third flow barrier 986 arranged proximate to the ports 918, 976. In various implementations, the flow barriers 982, 984, and 986 may be formed from a different material than the body’s convex outer surface 912. Specifically, in the implementation shown in FIG.18, the flow barriers 982, 984, and 986 are each formed of a self-healing silicone material. However, in other implementations, the convex outer surface 912 and the flow barriers 982, 984, 986 may be formed out of the same material. In yet further implementations, one or more of the flow barriers 982, 984, 986 may be formed as a single contiguous component. [00108] Each of the flow barriers 982, 984, 986 are generally shaped such that its outer surface forms a consistent contour along the superior portion of the body 910 (e.g., such that the
Attorney Docket No.10063-107WO1 outer surfaces of the flow barriers 982, 984, 986 are substantially flush and aligned with the convex outer surface 912 of the body 910 and the other flow barriers 982, 984, 986 so that the presence of the flow barriers is substantially non-perceptible from touching the outer surface of the device 900 ). In some implementations, all or part of the outer surfaces of the flow barriers 982, 984, 986 define an exterior surface of the body 910. [00109] In various implementations, the flow barriers 982, 984, 986 further define recesses for receiving and surrounding the expansion port 918 and the aspiration port 976. In some implementations, one or more of the flow barriers 982, 984, 986 substantially encase one or both of the expansion port 918 and the aspiration port 976. In this way, the flow barriers 982, 984, 986 are positioned to prevent the inadvertent puncture of the body 910 in areas surrounding the ports 918, 976. Accordingly, the flow barriers 982, 984, 986 assist in preventing the exit of expansion fluid contained within interior volume 916 or seroma contained within the aspiration port 976 into the patient’s body. [00110] In use, a needle may be used to puncture one or more of the flow barriers 982, 984, 986 to access the expansion port 918 or aspiration port 976. [00111] In the illustrated implementation, the second flow barrier 984 is disposed over and around the expansion port 918. In particular, the second flow barrier 984 is positioned over the expansion port 918 within a recess of the first flow barrier 982 and defines an exterior surface of the body 910. The third flow barrier 986 is disposed such that it immediately encases the aspiration port 976 and is positioned within a recess of the first flow barrier 982. [00112] In various implementations, the second flow barrier 984 and the third flow barrier 986 may be formed of a material with a higher density than the first flow barrier 982. In this way, an electronic sensor configured to detect changes in capacitance generated by the density differences between the flow barriers may be used to locate the expansion port 918 and aspiration port 976. In other implementations, each of the flow barriers 982, 984, 986 may be formed of materials having different densities. Thus, in addition to the protective functionality provided by the flow barriers 982, 984, 986, the flow barriers offer enhanced ability to locate the ports 918, 976 using non-magnetic techniques. This allows the breast tissue expander device 900 to avoid interfering with a variety of patient medical procedures, such as MRIs. [00113] In various other implementations, the device 900 may include any combination of one or more of the first flow barrier 982, the second flow barrier 984, and the third flow barrier 986.
Attorney Docket No.10063-107WO1 [00114] A number of example implementations are provided herein. However, it is understood that various modifications can be made without departing from the spirit and scope of the disclosure herein. As used in the specification, and in the appended claims, the singular forms “a,” “an,” “the” include plural referents unless the context clearly dictates otherwise. The term “comprising” and variations thereof as used herein is used synonymously with the term “including” and variations thereof and are open, non-limiting terms. Although the terms “comprising” and “including” have been used herein to describe various implementations, the terms “consisting essentially of” and “consisting of” can be used in place of “comprising” and “including” to provide for more specific implementations and are also disclosed. [00115] Disclosed are materials, systems, devices, methods, compositions, and components that can be used for, can be used in conjunction with, can be used in preparation for, or are products of the disclosed methods, systems, and devices. These and other components are disclosed herein, and it is understood that when combinations, subsets, interactions, groups, etc. of these components are disclosed that while specific reference of each various individual and collective combinations and permutations of these components may not be explicitly disclosed, each is specifically contemplated and described herein. For example, if a device is disclosed and discussed each and every combination and permutation of the device are disclosed herein, and the modifications that are possible are specifically contemplated unless specifically indicated to the contrary. Likewise, any subset or combination of these is also specifically contemplated and disclosed. This concept applies to all aspects of this disclosure including, but not limited to, steps in methods using the disclosed systems or devices. Thus, if there are a variety of additional steps that can be performed, it is understood that each of these additional steps can be performed with any specific method steps or combination of method steps of the disclosed methods, and that each such combination or subset of combinations is specifically contemplated and should be considered disclosed.