Patent Application
20180092737
The present disclosure relates generally to devices for improving breast surgeries, including light-weight implants that may be used as temporary or permanent space fillers.
Breast reconstruction post mastectomy has evolved over the last half century due to advances in surgical techniques and technology. Initially, surgeons required the use of tissue expanders post mastectomy to expand the skin due to insufficient remaining tissue. Tissue expanders were inflated to the desired size over a period of weeks or months to create a breast pocket that matched the approximate size and shape of the contralateral breast. Surgeons generally placed these devices in the sub muscular position (i.e., beneath the pectoralis major and serratus muscles), and while aesthetic results were not ideal, this procedure did afford benefits.
Later advances in surgical techniques included the use of the latissimus dorsi muscle. As with prior techniques, the pectoralis major is elevated and a tissue expander is placed beneath it. However, instead of raising the serratus to cover the lower pole of the expander, the latissimus muscle is moved from the back of the patient, and sutured to the edge of the pectoralis to cover the lower pole and form the inframammary fold by attaching the latissimus muscle to the chest wall.
Still later, ALLODERM® (LIFECELL CORPORATION, Branchburg, N.J.), and other acellular tissue matrix products, were added. ALLODERM® can be used to reinforce weakened skin in the lower pole, thereby eliminating the need to mobilize the latissimus dorsi for the same purpose. As a result, surgeons have been able to achieve similar aesthetic results as with the latissimus procedure without the morbidity associated with dissecting and moving that muscle (e.g., donor site pain and complications, and lack of muscle functionality).
In addition, there has been a greater acceptance of skin-sparing and skin and nipple-sparing mastectomies. With such procedures, there is more skin for reconstruction and less of a need for expansion of the breast-skin envelope. As a result, the intended functionality of traditional tissue expanders is often no longer necessary, and surgeons may instead use a device that surrogates for the shape and volume of the tissue removed during the mastectomy. This is well approximated by the size and shape of the proposed final silicone breast implant and, as such, well understood. While one can use a final implant to this end, surgeons face some limitations, including lack of suture tabs, heavy weight, lack of adjustability of size and volume, and cost.
Generally, the breast-skin flaps are not healthy because they have lost the blood supply from the underlying breast tissue removed during mastectomy. Among other things, there is not always a sufficient blood supply to clear infections, which can be especially challenging in the presence of synthetic implants. As a result, surgeons have found that when the silicone implants are placed under well vascularized muscle or rapidly vascularizing acellular dermal matrix (ADM) the incidence of implant loss is reduced.
Placement of the ADM, however, can be challenging. For example, the inferior edge of the ADM defines the inframammary fold where it attaches to the chest wall and reinforces the lower pole of the breast. For less experienced surgeons, or in cases where radical dissection of native tissue occurs, it can be difficult to accurately suture the ADM in the correct position or create the desired shape and curvature. Furthermore, surgeons have discovered that apposition of materials such as ALLODERM® with overlying skin flaps is important for long-term success.
It is possible to achieve good apposition between ADM and tissue using properly expanded tissue expanders or silicone implants. However, use of such devices can create some complications. For example, tissue expanders and silicone implants are relatively heavy, which can cause complications. Accordingly, there is a need for improved devices for breast procedures that can be used in conjunction with various ADMs and in a variety of different surgical procedures.
The present disclosure provides improved devices and methods for performing breast surgeries.
According to one aspect, a breast treatment system is provided. The system can include a low-density implant, wherein the implant comprises a material that does not allow fluid accumulation within the implant. In addition, the system can include an acellular tissue matrix composition, wherein the low-density implant and acellular tissue matrix are configured to allow implantation of the low-density implant and acellular tissue matrix composition within a breast site such that the low-density implant is held in contact with at least a portion of the acellular tissue matrix and holds the acellular tissue matrix in contact with surrounding tissue.
Also provided herein are methods of treating a breast. The methods can include performing a surgical procedure on a breast; implanting a low-density, implant within a space within the breast, wherein the implant comprises a material that does not allow fluid accumulation within the implant; and closing a surgical incision to maintain the low-density implant within the space within the breast. As discussed below, the methods can be used in conjunction with a variety of surgical procedures, can include later removal of the implant, or can further include implantation of a tissue matrix in contact with the implant and surrounding tissue.
Reference will now be made to exemplary embodiments, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. The drawings are not necessarily to scale.
Reference will now be made in detail to various embodiments of the disclosed devices and methods, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
In this application, the use of the singular includes the plural unless specifically stated otherwise. In this application, the use of “or” means “and/or” unless stated otherwise. Furthermore, the use of the term “including”, as well as other forms, such as “includes” and “included”, is not limiting. Any range described herein will be understood to include the endpoints and all values between the endpoints.
The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described. All documents, or portions of documents, cited in this application, including but not limited to patents, patent applications, articles, books, and treatises, are hereby expressly incorporated by reference in their entirety for any purpose.
The present disclosure relates generally to devices for surgical breast procedures and systems and methods relating to such devices. The devices can be used for tissue augmentation, repair or regeneration of damaged tissue, and/or correction of tissue defects. As such, the devices, systems, and methods discussed herein can be suitable for a wide range of surgical applications such as, for example, aesthetic surgery, breast reconstruction, breast augmentation, breast enhancement, breast reduction, and revisionary breast surgeries.
The devices of the present disclosure include low-density implants that can be used immediately following breast surgery, for example, immediately after skin-sparing mastectomy to maintain and/or augment the space that was occupied by the breast and subcutaneous tissue removed during a breast procedure. The device can facilitate proper placement of materials such as acellular dermal matrix and can specifically create a surface that accurately refelcts the shape of the breast skin envelope prior to a surgery, or a desired post-surgical size and shape, so that the acellular dermal matrix can be placed in the correct position without pleating or similar alteration.
The devices can also provide adequate pressure between the acellular tissue matrix and surrounding tissue (e.g., a skin flap in skin-sparing mastectomy), such that integration of the tissue matrix to the skin flap is improved.
According to one aspect, a breast treatment system is provided. The system can include a low-density implant, wherein the implant comprises a material that does not allow fluid accumulation within the implant. In addition, the system can include an acellular tissue matrix composition, wherein the low-density implant and acellular tissue matrix are configured to allow implantation of the low-density implant and acellular tissue matrix composition within a breast site such that the low-density implant is held in contact with at least a portion of the acellular tissue matrix and holds the acellular tissue matrix in contact with surrounding tissue.
The implant 10 can be formed of a variety of suitable materials. As noted above, the implant 10 can be formed of a low-density material that does not permit accumulation of fluid within the implant, and can be biocompatible, temperature stable (e.g., does not melt or soften excessively when implanted), and non-biodegradable. The low-density material is selected to provide a lightweight device that will produce little stress on surrounding tissues, thereby preventing surgery failure due to host tissue or implant failure, especially during periods shortly after surgery when surrounding tissues are healing and while tissue is being formed within the regenerative tissue matrix 20.
Furthermore, the implant can be produced from a material that does not permit fluid accumulation to (1) prevent weight increase, (2) prevent ingrowth of cells and tissues, (3) and prevent increased infection risk due to fluid ingress. By preventing ingrowth of cells and tissues, the implant 20 may be removed at a later time (e.g., after healing of tissues and generation of a supporting tissue structure with the tissue matrix 20).
A variety of suitable low-density materials may be selected. For example, in one embodiment, the materials comprise a closed-cell foam. Suitable polymers that may be used to form such foams can include polyurethane, silicone, polyvinylchloride, polytetrafluoroethylene, acrylate-based polymers, and/or polyethylene. In some embodiments, more than 60% of the cells, more than 70% of the cells, more than 80% of the cells, or 90% of the cells can be closed within the closed-cell foam.
Alternatively, or in addition to including a closed-cell foam, the implant may be formed of an open- or closed-cell foam covered by an outer moisture-impermeable layer to prevent fluid and cell ingress. The outer layer can be biocompatible, temperature stable (e.g., does not melt or soften excessively when implanted), and non-biodegradable. For example,
In some embodiments, the low-density material can have a pore size of less than 200 microns, less than 100 microns, or less than 50 microns. In some embodiments, the outer moisture-impermeable layer can have a pore size of less than 200 microns, less than 100 microns, or less than 50 microns. In embodiments with an outer moisture-impermeable layer, the interior of the implant can be formed of a material having a larger pore size than the outer layer.
The low-density breast implant can include a low-density material that is sufficiently compressible according to application-specific requirements. In some embodiments, the density of the low-density material can be chosen to achieve a certain weight or mass for the implant 20 at a given implant size or volume. In embodiments where the entire implant is comprised of a closed-cell foam, the density of the low-density material can be chosen to be low. In embodiments where the implant includes an outer moisture-impermeable layer, the outer layer can be formed of a closed-cell foam or other material of higher density, and the interior of the implant can be formed of a lower density material.
For example, silicone or saline breast implants can range in volume from 100 cm3 to 800 cm3. The masses of silicon or saline breast implants can range from 100 g to 800 g. In accordance with various embodiments, low-density implants as described herein can have masses of between 1% and 10%, 1% and 5%, 1% and 20%, between 10% and 30%, 20% and 30%, 10% and 40%, or between 20% and 50% of the mass of a similarly sized or shaped silicone or saline implant. In accordance with various embodiments, low-density implants as described herein can have masses of less than 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5%, or 1% of the mass of a similarly sized or shaped silicone or saline implant. In some embodiments, a surgeon can choose the material composition of a low-density implant based upon patient-specific factors such as the extent or severity of damage to surrounding tissue, breast size or shape, and amount of remaining tissue after an operation. In various embodiments, the density of the low-density material can be between 0.02 g/cm3 and 1.2 g/cm3 or any density corresponding to a percent mass, as listed above, that will allow a desired mass as compared to the mass of a similarly sized saline-filled implant or tissue expander.
As noted above, the implant 10 can have a variety of shapes, sizes and configurations. For example, as shown in
In addition, the implants of the present disclosure need not have typical breast implant (teardrop or rounded) shapes. For example, the implants can have other shapes including, for example, irregular shapes (
The implants may also have features that permit some change in shape or volume either before or after implantation. For example,
In various embodiments, the internal structure 710 can be configured to allow control of specific shapes or device attributes. For example, the structure can be designed such that injection of fluid effects a change in a particular implant dimension (e.g., base size, projection, or volume, or some selected combination thereof). For example, in one embodiment, the implant may allow little expansion in one characteristic (e.g., base size), while allowing easy expansion in a direction that increases desired dimension such as projection. Such control may be effected by controlling bladder elastic properties, e.g., by selective cross-linking or control of material thickness.
In order to adjust the implant volume, a surgeon may insert or remove fluids (e.g., saline), gels, or gases, from the internal structure 710. For example, the implant may include a port 740 for receiving a needle or cannula to transfer fluid. Alternatively, the implant can be formed of a material that can receive a narrow-bore needle to inject fluid, but which will be self-sealing.
Also provided herein are methods of treating a breast. The methods can include performing a surgical procedure on a breast; implanting a low-density implant within a space within the breast, wherein the implant comprises a material that does not allow fluid accumulation within the implant; and closing a surgical incision to maintain the low-density implant within the space within the breast. As discussed below, the methods can be used in conjunction with a variety of surgical procedures, can include later removal of the implant, and can further include implantation of a tissue matrix in contact with the implant.
After the site is selected, the surgical procedure (e.g., mastectomy, lumpectomy, surgical access) is performed (Step 810), and the low-density implant 10 (or variations thereof described above) is implanted (Step 820). At the same time, a tissue matrix is implanted and correctly positioned, for example, by partially wrapping around the implant, and if necessary, anchoring the matrix to surrounding tissues or the implant. In some cases, a tissue matrix may be omitted, and the surgery closed with just the implant in place. In such cases, the surgeon may allow tissue to heal around the implant and consider implantation of the tissue matrix later.
In some cases, a surgeon may adjust the volume of the implant (Step 830) either to achieve desired aesthetic results, achieve proper apposition or placement of the tissue matrix and surrounding tissue, or to stretch tissue a desired amount. The surgeon may then close the incision (Step 840). The implant volume can be adjusted as described with devices illustrated in
After closing the incision, the surgeon may wait a period of time (Step 850), during which the patient will heal from the operation, and during which time tissue can form within the tissue matrix. After an appropriate period (e.g., weeks or months), the surgeon can then operate again and remove the implant. If appropriate, the implant can then be replaced by a more traditional breast implant such as a silicone or saline-filled implant, or if needed, a normal tissue expander (Step 860).
As noted above, the implants and systems described herein can be used in a variety of anatomical sites and in various surgical methods. For example,
As shown in
Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of this disclosure. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the disclosed devices and methods being indicated by the following claims.
This application claims priority under 35 USC § 119 to U.S. Provisional Application No. 62/403,344, which was filed on Oct. 3, 2016, and which is herein incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62403344 | Oct 2016 | US |
