Patent Application
20250177118
Breast tissue expansion is a common technique used for breast reconstruction. After a mastectomy, a breast tissue expander is disposed under the breast skin and muscle to be coupled 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.
Previous breast tissue expanders included textured surfaces that acted similarly to hook-and-loop connectors with the adjacent tissue 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, leading to the recall and discontinuation of textured breast tissue expanders.
To address this increased risk of breast implant-associated anaplastic large cell lymphoma, current breast tissue expanders feature smooth surfaces. Because the smooth surfaces of the current breast tissue expanders no longer benefitted from the hook-and-loop-like coupling of the previous textured expanders, current breast 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.
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 to the chest tissue wall for the surgeon. For example, nipple sparing mastectomies involve a small incision overlying the nipple 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.
Thus, there exists a need for a smooth surface breast tissue expander that can be securely coupled to the chest tissue wall by one or more easily accessible suture tabs without causing the expander to hang by the sutures from the chest tissue.
Another issue with current breast tissue expanders is their lack of ability to drain seroma from around the expander throughout the expansion process. Typically, a drain tube is disposed adjacent a breast tissue expander when the expander is initially implanted. The removal of tissue from the breast during a mastectomy can lead to seroma accumulation around the expander, which can be drained using the drain tube. The separate drain tube is eventually removed from the patient while the expander remains implanted. However, as the expander is expanded, any empty spaces in the breast around the expander can accumulate seroma.
Some current breast tissue expanders include perforated drains along the inferior end of the expander and aspiration ports that, similar to the expansion ports of the expanders, allow access to the drain to aspirate the seroma adjacent the drain. However, these drains can become clogged and are not always located where pockets of seroma may form.
Thus, there exists a need for a breast tissue expander that has the ability to better drain seroma around the expander without becoming clogged.
Some of the aspects of the present disclosure relate to a breast tissue expander device, the device comprising: a body having a first surface, a second surface opposite the first surface, a circumferential edge of the body defined along an abutment of the first surface and the second surface, a superior end, and an inferior end opposite the superior end; the first surface defines a convex surface, wherein a portion of the body has a maximum thickness of the body as measured from the first surface to the second surface, and the portion of the body is closer to the inferior end than to the superior end; and one or more tabs for coupling the device to a patient, each of the one or more tabs having a first side, a second side opposite from the first side, a first edge extending from the first side to the second side, and a second edge opposite from the first edge, wherein the first edge of each of the one or more tabs is coupled to the body, wherein at least one of the tabs is coupled to the inferior end of the body, wherein the at least one of the tabs defines a total of two or more suture openings extending from the respective first side to the respective second side.
In some aspects, in addition, or in the alternative, to any preceding aspects, all of the suture openings of the device are defined by the at least one of the tabs.
In some aspects, in addition, or in the alternative, to any preceding aspects, the one or more tabs comprises one tab.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs is coupled to the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs extends along at least 75% of the inferior end of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs extends along 70 mm-100 mm of the inferior end of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, the one of the at least one tabs includes two or more suture openings.
In some aspects, in addition, or in the alternative, to any preceding aspects, each of the two or more suture openings are spaced 2 mm-10 mm apart from each other.
In some aspects, in addition, or in the alternative, to any preceding aspects, the each of the two or more suture openings are spaced 4 mm-6 mm apart from each other.
In some aspects, in addition, or in the alternative, to any preceding aspects, the two or more suture openings comprises four or more suture openings.
In some aspects, in addition, or in the alternative, to any preceding aspects, the device further comprises a drain tube.
In some aspects, in addition, or in the alternative, to any preceding aspects, the drain tube is a Blake drain.
In some aspects, in addition, or in the alternative, to any preceding aspects, a center line of the drain tube extends substantially parallel to the circumferential edge along at least the inferior end of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs is coupled to the inferior end of the body, the at least one of the tabs is coupled to a portion of the body that is closer than the drain tube to the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs is coupled to the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the second edge of the at least one of the tabs extends at least 10 mm from the drain tube.
In some aspects, in addition, or in the alternative, to any preceding aspects, the inferior end of the body includes an inframammary ridge portion, the drain tube extends along the inframammary ridge portion.
In some aspects, in addition, or in the alternative, to any preceding aspects, a center line of the drain tube extends around at least 50% of the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the center line of the drain tube extends around at least 75% of the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the device is a smooth surface tissue expander (STE).
Some of the aspects of the present disclosure relate to a breast tissue expander device, the device comprising: a body having a first surface, a second surface opposite the first surface, a circumferential edge of the body defined along an abutment of the first surface and the second surface, a superior end, and an inferior end opposite the superior end, the first surface defining a convex surface, wherein a portion of the body has a maximum thickness of the body as measured from the first surface to the second surface, and the portion of the body is closer to the inferior end than to the superior end; and one or more tabs for coupling the device to a patient, each of the one or more tabs having a first side, a second side opposite from the first side, a first edge extending from the first side to the second side, and a second edge opposite from the first edge, wherein the first edge of each of the one or more tabs is coupled to the body, wherein at least one of the one or more tabs defines two or more suture openings extending from the first side to the second side.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs is coupled to the inferior end of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, all of the suture openings of the device are defined by the at least one of the tabs.
In some aspects, in addition, or in the alternative, to any preceding aspects, the one or more tabs comprises one tab.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs is coupled to the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs extends along at least 75% of the inferior end of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs extends along 70 mm-100 mm of the inferior end of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, each of the two or more suture openings are spaced 2 mm-10 mm apart from each other.
In some aspects, in addition, or in the alternative, to any preceding aspects, each of the two or more suture openings are spaced 4 mm-6 mm apart from each other.
In some aspects, in addition, or in the alternative, to any preceding aspects, the two or more suture openings comprises four or more suture openings.
In some aspects, in addition, or in the alternative, to any preceding aspects, further comprising a drain tube.
In some aspects, in addition, or in the alternative, to any preceding aspects, the drain tube is a Blake drain.
In some aspects, in addition, or in the alternative, to any preceding aspects, a center line of the drain tube extends substantially parallel to the circumferential edge along at least the inferior end of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs is coupled to the inferior end of the body, the at least one of the tabs is coupled to a portion of the body that is closer than the drain tube to the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs is coupled to the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the second edge of the at least one of the tabs extends at least 10 mm from the drain tube.
In some aspects, in addition, or in the alternative, to any preceding aspects, the inferior end of the body includes an inframammary ridge portion, the drain tube extends along the inframammary ridge portion.
In some aspects, in addition, or in the alternative, to any preceding aspects, a center line of the drain tube extends around at least 50% of the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the center line of the drain tube extends around at least 75% of the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the device is a smooth surface tissue expander (STE).
Some of the aspects of the present disclosure relate to a breast tissue expander device, the device comprising: a body having a first surface, a second surface opposite the first surface, a circumferential edge of the body defined along an abutment of the first surface and the second surface, a superior end, and an inferior end opposite the superior end, the first surface defining a convex surface, wherein a portion of the body has a maximum thickness of the body as measured from the first surface to the second surface, and the portion of the body is closer to the inferior end than to the superior end; and a drain tube coupled to the body and extending substantially parallel to the circumferential edge, wherein a center line of the drain tube extends around at least 50% of the circumferential edge of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, the center line of the drain tube extends around at least 75% of the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the drain tube extends along the entire inferior end of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, the drain tube is a Blake drain.
In some aspects, in addition, or in the alternative, to any preceding aspects, the body of the device defines an aspiration port in fluid communication with at least one end of the drain tube.
In some aspects, in addition, or in the alternative, to any preceding aspects, the aspiration port is in fluid communication with two ends of the drain tube.
In some aspects, in addition, or in the alternative, to any preceding aspects, the inferior end of the body includes an inframammary ridge portion, and the drain tube extends along the inframammary ridge portion.
In some aspects, in addition, or in the alternative, to any preceding aspects, further comprising one or more tabs for coupling the device to a patient, each of the one or more tabs having a first side, a second side opposite from the first side, a first edge extending from the first side to the second side, and a second edge opposite from the first edge, wherein the first edge of each of the one or more tabs is coupled to the body, wherein at least one of the tabs is coupled to the inferior end of the body, wherein the at least one of the tabs defines a total of two or more suture openings extending from the respective first side to the respective second side.
In some aspects, in addition, or in the alternative, to any preceding aspects, all of the suture openings of the device are defined by the at least one of the tabs.
In some aspects, in addition, or in the alternative, to any preceding aspects, the one or more tabs comprises one tab.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs is coupled to the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs extends along at least 75% of the inferior end of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs extends along 70 mm-100 mm of the inferior end of the body.
In some aspects, in addition, or in the alternative, to any preceding aspects, one of the at least one tabs includes two or more suture openings.
In some aspects, in addition, or in the alternative, to any preceding aspects, each of the two or more suture openings are spaced 2 mm-10 mm apart from each other.
In some aspects, in addition, or in the alternative, to any preceding aspects, each of the two or more suture openings are spaced 4 mm-6 mm apart from each other.
In some aspects, in addition, or in the alternative, to any preceding aspects, the two or more suture openings comprises four or more suture openings.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs is coupled to the inferior end of the body, and the at least one of the tabs is coupled to a portion of the body that is closer than the drain tube to the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the at least one of the tabs is coupled to the circumferential edge.
In some aspects, in addition, or in the alternative, to any preceding aspects, the second edge of the at least one of the tabs extends at least 10 mm from the drain tube.
In some aspects, in addition, or in the alternative, to any preceding aspects, the device is a smooth surface tissue expander (STE).
Example features and implementations are disclosed in the accompanying drawings. However, the present disclosure is not limited to the precise arrangements and instrumentalities shown.
The devices, systems, and methods disclosed herein provide for a breast tissue expander device with a suture tab extending from the inferior end of the body of the device. The tab can be elongated and extend along most of the inferior end of the body. 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 ridge of the patient. The location of the tab along the inferior end of the body of the device provides a “shelf”' that allows the body to be supported from below the body by the coupled tab rather than being hung from one or more suture tabs coupled along the superior end or the sides of the body like with current breast tissue expander devices.
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.
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 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 fluid such that the fluid can be aspirated through an integrated port of the expander.
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.
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.
Various implementations include a breast tissue expander device. The device includes a body and one or more tabs for coupling the device to a patient. The body has a first surface, a second surface opposite the first surface, a circumferential edge of the body defined along an abutment of the first surface and the second surface, a superior end, and an inferior end opposite the superior end. The first surface defines a convex surface. A portion of the body has a maximum thickness of the body as measured from the first surface to the second surface, and the portion of the body is closer to the inferior end than to the superior end. Each of the one or more tabs has a first side, a second side opposite from the first side, a first edge extending from the first side to the second side, and a second edge opposite from the first edge. The first edge of each of the one or more tabs is coupled to the body. At least one of the tabs is coupled to the inferior end of the body. The at least one of the tabs defines a total of two or more suture openings extending from the respective first side to the respective second side.
Various other implementations include a breast tissue expander device. The device includes a body and one or more tabs for coupling the device to a patient. The body has a first surface, a second surface opposite the first surface, a circumferential edge of the body defined along an abutment of the first surface and the second surface, a superior end, and an inferior end opposite the superior end. The first surface defines a convex surface. A portion of the body has a maximum thickness of the body as measured from the first surface to the second surface, and the portion of the body is closer to the inferior end than to the superior end. Each of the one or more tabs has a first side, a second side opposite from the first side, a first edge extending from the first side to the second side, and a second edge opposite from the first edge. The first edge of each of the one or more tabs is coupled to the body. At least one of the one or more tabs defines two or more suture openings extending from the first side to the second side.
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 sterile saltwater to flow into the cavity 116 of the body 110 to expand the body 110. Although the expansion port 118 shown in
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 ridge portion 128 configured to be located adjacent the inframammary ridge 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.
The body 110 of the device 100 shown in
The device 100 shown in
The tab 140 shown in
Each of the suture openings 150 shown in
Although the tab 140 shown in
In some implementations, such as the implementation shown in
The drain 170 shown in
The drain tube 170 shown in
The axial ends of the drain tube 170 are coupled to a Y-connector 178 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
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.
The drain tube 170 shown in
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.
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.
Each of the tabs 340 includes two or more suture openings 350. Existing breast tissue expanders include tabs that each define only a single suture opening for coupling the device to the chest of the patient. The single suture allows the device to pivot about the suture out of position, and if the single suture fails, then the device can become decoupled from the patient's chest tissue. The two or more suture openings 350 of the tabs 340 of the device 300 shown in
The device 300 shown in
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
Although the tab 540 of the device shown in
The device 500 shown in
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.
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.
This application claims the benefit of priority to U.S. Provisional Application No. 63/314,858 filed Feb. 28, 2022, which is hereby incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/014168 | 2/28/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63314858 | Feb 2022 | US |
