Patent Application
20150025563
Soft tissue expansion techniques are used in reconstructive surgeries to stimulate the growth of new skin to create a stretched area of skin for placement of a prosthetic implant. A tissue expander device comprising an expandable balloon may be placed beneath a patient's skin or muscle and gradually expanded over a period of time to achieve a desired expanded tissue pocket. Soft tissue expansion may have advantages over conventional skin grafting for forming the tissue pocket, including providing a natural appearance in skin texture and color by matching the surrounding skin and an existing blood supply.
Tissue expanders may be used for the surgical reconstruction of the breast following mastectomy for breast cancer. Breast reconstruction is conventionally a two staged process in which the affected breast tissue and skin is removed in a first surgery (mastectomy). A collapsed or partially inflated tissue expander may be placed under the pectoralis major muscle behind the area of the removed breast during the first surgery to create a new breast pocket. The tissue expander may be post-operatively filled with a filler material such as saline or air over a period of time until the breast pocket achieves a desired volume to accommodate a final permanent breast implant. In a second surgery, the tissue expander may be removed and replaced with the final permanent breast implant or the breast may be reconstructed with the patient's own tissue with tissue flap surgery.
Current breast tissue expanders comprise a silicone elastomer shell with an injection port for injection of the filler material. The breast tissue expanders may comprise a conventional round full breast shape, a partial breast shape, or a contour shape for greater lower pole volume expansion of the breast pocket. Some breast tissue expanders may further comprise suture tabs for suturing the tissue expander to fascia on the patient's chest wall. The suture tabs may be small and difficult for the surgeon to access during surgery.
Once implanted under the pectoralis major muscle during the first stage surgery, a fibrous capsule of scar tissue forms over the tissue expander as part of a normal physiologic response of the tissue to a foreign object. It is into this encapsulated breast pocket that the final breast implant will be implanted. The thickness of the capsule may range from thin to heavily-thickened. The formation of the fibrous capsule may cause the breast pocket created by the tissue expander to be of inadequate dimensions or to become an undesirable rounded shape incapable of providing a desired teardrop shaped breast pocket. The teardrop shape of the breast pocket may provide a natural looking breast with either a round or an anatomically shaped final permanent breast implant. The fibrous capsule may also cause capsular contracture in which the breast pocket is constricted, causing deformation of the breast pocket, excessive firmness of the breast pocket, and/or pain.
As a result, in the second surgery, surgeons routinely perform an open capsulotomy in which the breast pocket created by the tissue expander is further surgically modified to achieve the desired size and shape to accommodate the final permanent breast implant. The capsulotomy results in additional surgical time, complexity, and cost. Since the capsulotomy necessarily results in additional trauma to the tissue surrounding the breast pocket, the patient may experience additional pain and a longer recovery time. Further, the patient may develop complications such as tissue necrosis, bleeding, and/or irregularities in the chest wall and/or skin.
Various embodiments provide systems and methods for a temporary extended tissue expander. Systems and methods according to various aspects of the present invention may comprise an extended tissue expander configured to increase and/or customize the size and/or shape of a tissue pocket beyond the size and/or shape provided by a conventional tissue expander. The extended tissue expander may comprise a tissue expander coupled to an extension portion. In one embodiment, the extended tissue expander may preserve a breast pocket with a desired teardrop shape that does not need extensive surgical modification before placement of a final breast implant or a tissue flap. In another embodiment, the extended tissue expander may be modified to the precise dimensions of a final breast implant for the simple exchange of the extended tissue expander for the final breast implant.
A more complete understanding of the present invention may be derived by referring to the detailed description when considered in connection with the following illustrative figures. In the following figures, like reference numbers refer to similar elements and steps throughout the figures.
Elements and steps in the figures are illustrated for simplicity and clarity and have not necessarily been rendered according to any particular sequence or scale. For example, steps that may be performed concurrently or in different order are illustrated in the figures to help to improve understanding of embodiments of the present invention.
The figures described are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. Various aspects of the present invention may be more fully understood from the detailed description and the accompanying drawing figures, wherein:
The present invention may be described in terms of functional block components and various processing steps. Such functional blocks may be realized by any number of components configured to perform the specified functions and achieve the various results. For example, methods and systems according to various aspects of the present invention may be practiced in conjunction with any number of systems and methods for tissue reconstruction, and the system described is merely one exemplary application for the invention. Various representative implementations of the present invention may be applied to any type of conventional tissue expander.
The particular implementations shown and described are illustrative of the invention and its best mode and are not intended to otherwise limit the scope of the present invention in any way. For the sake of brevity, conventional manufacturing, connection, preparation, sterilization, and other functional aspects of the system may not be described in detail. Furthermore, the connecting lines shown in the various figures are intended to represent exemplary functional relationships and/or steps between the various elements. Many alternative or additional functional relationships or physical connections may be present in a practical system.
Various aspects of the invention provide methods, apparatus, and systems for making and using an extended tissue expander system in reconstructive surgeries. A detailed description of various embodiments is provided as a specific enabling disclosure that may be generalized to any application of the disclosed systems and methods in accordance with the various described embodiments.
Various representative implementations of the present invention may be applied to any appropriate system for tissue reconstruction. Certain representative implementations may include, for example, providing any suitable system or method for extending a conventional tissue expander to increase and/or customize the size and/or shape of a tissue pocket for accommodating a final implant or a tissue flap. In one embodiment, the extended tissue expander system may comprise a static nonexpandable extension portion coupled to any conventional inflatable tissue expander, such as a tissue expander used for facial reconstruction or breast reconstruction following mastectomy. In one embodiment, the combination of the static extension portion with the conventional tissue expander may maintain established soft tissue expansion methods and techniques, such as for breast tissue expansion, while providing a larger tissue pocket for accommodating the size and/or shape of the final implant and an improved surgical outcome. In one embodiment as applied to breast reconstruction, the extension portion may provide additional height to the resulting tissue pocket beyond an upper boundary of the inflated tissue expander without anterior expansion away from the chest wall, resulting in a teardrop shaped tissue pocket that may form a more natural tight shape to receive the final breast implant. The tissue expander may comprise any suitable tissue expander for expanding soft tissue, such as a breast, eyelid, and/or lip.
In an exemplary embodiment of the present invention, the extended tissue expander may be configured for submuscular implantation in the breast after mastectomy in a female patient to form a breast pocket comprising expanded skin. In some embodiments, the extended tissue expander may be implanted during a first surgery of a two staged breast reconstruction surgery. In one embodiment, the extended tissue expander may be configured for submuscular implantation in the chest of a male for a two staged male breast augmentation.
The tissue expander of the extended tissue expander may be in an empty collapsed state when surgically implanted or it may be at least partially filled with a filler material such as a saline solution or air. The extended tissue expander may be post-operatively filled with the filler material over time until the breast pocket reaches a desired volume. A second surgery of the two staged surgery may occur weeks to months after the first surgery wherein the extended tissue expander may be removed and replaced with a final breast implant or a tissue flap. An implanted tissue expander may not be intended to be a permanent implant by its manufacturer.
Referring to
In some embodiments, the tissue expander 105 may be a contour profile tissue expander for extending a lower portion of the breast pocket. The contour profile tissue expander may comprise or be similar to the Mentors® Contour Profile® Tissue Expander.
In another embodiment, the tissue expander 105 may comprise a shape that provides directional expansion to at least a portion of the breast pocket. For example, the directionally expanding tissue expander 105 may comprise or be similar to Dacron® reinforced smooth tissue expanders produced by Mentor®, such as smooth round, smooth rectangle, smooth crescent, or smooth elliptical tissue expanders. Further, the directionally expanding tissue expander 105 may comprise or be similar to the textured or smooth crescent tissue expanders from Sientra®. Further, the directionally expanding tissue expander 105 may comprise or be similar to the Sientra® ACX™ double chamber anatomical controlled breast tissue expander which may be configured for differential inflation of one or both chambers.
In some embodiments, the tissue expander 105 may be configured to create a full breast shaped breast pocket. For example, the tissue expander 105 may comprise or be similar to any of the Mentor® CPX2™, CPX3™, or CPX™ 4 breast tissue expanders in a low, medium, or tall height. Further, the tissue expander 105 may comprise or be similar to Allergan Natrelle® 133 Tissue Expanders. Further, the tissue expander 105 may comprise or be similar to Sientra® round breast tissue expanders or Sientra® anatomical controlled breast tissue expanders in a low, moderate, or full height.
Referring to
In various embodiments, the suture tabs 410 may be securely coupled to the tissue expander 105 by any suitable method. In one embodiment, the suture tabs 410 may be coupled to the tissue expander 105 with a biocompatible adhesive such as a silicone adhesive. In another embodiment, the suture tabs 410 may be coextruded with the tissue expander 105. In yet another embodiment, the suture tabs 410 may be incorporated into a mold for creating the tissue expander 105.
In various embodiments, the tissue expander 105 may comprise a smooth surface, a surface texture 115, or a combination thereof. The surface texture 115 may promote adherence of the tissue expander 105 to surrounding tissue and/or to the fibrous capsule that forms post-operatively around the extended tissue expander 100. In some embodiments, the surface texture 115 may support immobility of the tissue expander 105 within the breast pocket during expansion of the tissue expander 105. In some embodiments, the surface texture 115 may reduce the incidence of adverse capsular contracture that may cause deformation of the tissue expander 105. In one embodiment, the surface texture 115 of the tissue expander 105 may comprise raised microscale nodules providing a rough feel. For example, the Mentor® tissue expanders described above may comprise SILTEX® surface texturing having microscale nodules. In another embodiment, the surface texture 115 of the tissue expander 105 may comprise surface depressions. For example, the Allergan Natrelle® 133 tissue expanders described above may comprise Biocell® surface texturing having microscale depressions.
The extended tissue expander 100 may further comprise the extension portion 120. The extension portion 120 may comprise any suitable extension element that may be coupled to the tissue expander 105 and provides additional height above the tissue expander 105 within the breast pocket without resulting in substantial anterior expansion away from the chest wall. As a result, in some embodiments, the fibrous capsule may form around both the extension portion 120 and the tissue expander 105 to form a teardrop shaped breast pocket. In one embodiment, the extension portion 120 may have a uniform thickness. In another embodiment, the position of the extension portion 120 may be static in relation to the tissue expander 105. In yet another embodiment, the extension portion 120 may be configured to be sutured to the fascia of the patient's chest wall.
In various embodiments, at least one dimension of the extension portion 120 may be customized during the first surgery of a two staged breast reconstruction to match the desired dimensions of the final encapsulated breast pocket that extends to a desired anatomic boundary of the patient's breast. For example, the extension portion 120 may be trimmed such that the boundaries of the breast pocket may provide a footprint of a breast with the desired dimensions onto the chest wall. In some embodiments, the breast pocket having the footprint of the breast on the chest wall may provide a loose pocket needed for some types of final breast implants such as smooth or textured round breast implants of any size that are configured to move similarly to a natural breast within the loose breast pocket.
In some embodiments, the size and/or shape of the extension portion 120 may be customized during the first surgery to the precise dimensions of a preselected final breast implant, such as a form stable, highly cohesive gel breast implant of any volume. The customized extension portion 120 may provide for the formation of a tight pocket for the simple exchange of the final breast implant for the extended tissue expander 100 and obviating the need for the surgeon to perform a capsulotomy during the second surgery.
Formation of the tight pocket may also prevent the need for capsulorrhaphy in a third surgery to revise the breast pocket to be smaller, resulting in reduced movement and/or altering the position of the final breast implant within the breast pocket. Capsulorrhaphy may be performed to reduce adverse unnatural looking movement or position of the final breast implant such as lateral movement when the patient lies down, migration on the chest wall, and/or rotation of a shaped implant within the breast pocket. Capsulorrhaphy may comprise placing internal sutures along one or more borders of the breast pocket and/or the use of biomaterials such as acellular dermal matrix (ADM's) that provide a cell free lattice of tissue to support an ingrowth of the patient's native tissue, resulting in a smaller breast pocket.
Referring again to
The extension of the extension portion 120 beyond the dimensions of the posterior surface of the tissue expander 105 may provide the surgeon with ample material for suturing the extended tissue expander 100 to fascia on the patient's chest wall to prevent migration and/or rotation of the extended tissue expander 100 in the breast pocket. In some embodiments, as described below, the extension portion 120 may be configured to be trimmed to the precise dimensions of the final breast implant to provide a tight breast pocket, such as for receiving a form stable, highly cohesive gel breast implant. In some embodiments, the extension portion 120 may be trimmed to provide a footprint of a breast with the desired dimensions onto the chest wall, such as for receiving a smooth or textured round final breast implant.
Referring to
The upper portion 130 of the extension portion 120 may provide the surgeon with ample material for suturing the extended tissue expander 100 to fascia on the patient's chest wall to prevent migration and/or rotation of the extended tissue expander 100 in the breast pocket. However, in some embodiments, the extension portion 120 may not exceed the width of the tissue expander 105 and/or may not extend below the posterior surface 615 of the tissue expander 105. As a result, the extension portion 120 may not provide lateral and/or inferior material for suturing the extended tissue expander 100 to the fascia. In one embodiment, the suture tabs 410 may be provided on the sides and/or bottom of the tissue expander 105 for additional anchor points for suturing the extended tissue expander 100 to the patient's fascia and/or other native tissues. In some embodiments, the upper portion 130 of this embodiment of the extension portion 120 may be configured to be trimmed to the precise dimensions of the final breast implant to provide a tight breast pocket or to provide the footprint of the breast with the desired dimensions onto the chest wall.
Referring to
In various embodiments, the extension portion 120 may comprise any suitable static nonexpandable biocompatible material. The biocompatible material may be a nonbioabsorbable material such that the extension portion 120 remains intact for the duration of the implantation of the extended tissue expander 100. Further, in some embodiments, the extension portion 120 may comprise a substantially resilient material that may be bent or folded for insertion into the breast pocket and subsequently reassume its intended shape. For example, in some embodiments, the extension portion 120 may comprise a sheet of silicone elastomer or polypropylene. In various embodiments, the extension portion 120 may comprise a smooth surface, any appropriate textured surface, or a combination thereof. In some embodiments, the textured surface may comprise the surface texture 115 as described above for the tissue expander 105, such as SILTEX™ or Biocell® surface texturing.
The extension portion 120 may comprise any suitable uniform or variable thickness for maintaining an open space above the tissue expander 105 in the breast pocket by preventing the formation of the fibrous capsule in the space occupied by the extension portion 120. In this manner, the extension portion 120 may provide at least additional height to the resulting breast pocket beyond the upper boundary 125 of the inflated tissue expander 105 without substantial anterior expansion of the breast pocket away from the chest wall, resulting in a teardrop shaped breast pocket that may form a more naturally shaped tight tissue pocket for receiving the final breast implant. For example, in one embodiment, the extension portion 120 may be about 1 to 2 centimeters thick. In another embodiment, the extension portion 120 may be more than 2 centimeters thick. In another embodiment, the extension portion 120 may be less then 1 centimeter thick.
Referring to
In another embodiment, a variety of extended tissue expanders 100 may be constructed wherein the untrimmed upper portion 130 may be configured to accommodate the height of a petite patient or a tall patient. For example, the untrimmed upper portion 130 may be 10 centimeters for a petite patient or 15 centimeters for a tall patient. In another embodiment, the untrimmed upper portion 130 may be at least twice the height of the tissue expander 105. In yet another embodiment, the untrimmed upper portion 130 may extend just above the upper boundary 125 of the tissue expander 105 to at least three or more times the height of the tissue expander 105.
Referring to
The surgical fabric 135 may be embedded in or attached to the extension portion 120 by any suitable method. For example, in one embodiment, the surgical fabric 135 may be attached to an exterior surface of the extension portion 120 (not shown) with a silicone-based adhesive. In another embodiment, the extension portion 120 may be coextruded with the surgical fabric 135. In yet another embodiment, the extension portion 120 may be molded around the surgical fabric 135. In yet another embodiment, the surgical fabric 135 may be embedded in the extension portion 120 by using a sandwich construction method in which the surgical fabric 135 is disposed within the films of the silicone elastomer of the extension portion 120.
Referring to
In various embodiments, the extension portion 120 may be coupled to the tissue expander 105 by any suitable method. In one embodiment, the extension portion 120 may be secured in a fixed position relative to the tissue expander 105 such that the extension portion 120 cannot rotate or otherwise move in relation to the tissue expander 105. For example, in one embodiment, the extension portion 120 may be coupled directly to the tissue expander 105 with an adhesive such as a silicone adhesive. In another embodiment, the extension portion 120 may be coupled indirectly to the tissue expander 105. For example, the tissue expander 105 may comprise a fastener such as a press stud for attachment of the extension portion 120. In yet another embodiment, the extension portion 120 may be coextruded or included as part of a mold for the tissue expander 105. In this embodiment, the extension portion 120 and the tissue expander 105 may comprise a single continuous device.
In various embodiments, the size and/or shape of the breast pocket may be customized by trimming the extension portion 120 according to an individual patient's anatomy and/or the size of any final breast implant. In one embodiment, the extension portion 120 may be trimmed to the desired boundaries of the final encapsulated breast pocket. For example, the desired boundaries of the final encapsulated breast pocket may be considered to be a footprint of the breast or the desired breast on the chest wall. By customizing the size of the extension portion 120, a substantially simple exchange of the final breast implant for the implanted extended tissue expander 100 may be facilitated, such as during the second stage surgery of breast reconstruction. In some embodiments, the extension portion 120 may be configured to be trimmed, such as with surgical scissors or a scalpel, to substantially match the size and shape of the final breast implant and to fit the submuscular implantation area created by the surgeon in the first stage surgery. For example, referring again to
The extension portion 120 of the extended tissue expander 100 may be trimmed to create a breast pocket that may accommodate any suitable final breast implant, such as silicone elastomer or polypropylene breast implants. For example, in one embodiment, the breast implant may comprise any suitable shape such as round, oval, or an anatomic shape such as a teardrop. The breast implant may also contain any suitable filler material such as saline, cohesive silicone gel, and/or a highly cohesive silicone gel. The breast implant may further comprise any suitable surface texture such as smooth or textured.
In various embodiments, the extension portion 120 may be trimmed to substantially exact dimensions of some final breast implants that may require a precisely formed tight breast pocket to maintain the orientation of the final breast implant. Specifically, in one embodiment, the final breast implant may be a form stable, highly cohesive gel breast implant. The form stable, highly cohesive gel breast implant may be filled with a highly cohesive gel that retains the gel within the implant despite an implant rupture. The form stable, highly cohesive gel breast implant provides a tapered anatomical teardrop shape unlike conventional round breast implants. Current examples of form stable, highly cohesive gel breast implants include a Mentor® MemoryShape™ Breast Implant, Allergan Natrelle® Style 410 Breast Implant, and Sientra® Silimed® Breast Implants.
The form stable, highly cohesive gel breast implant may retain its tapered shape regardless of whether it moves or rotates within the breast pocket. As a result, the breast pocket created in the first surgery of a two stage breast reconstruction must also be a teardrop shape that precisely matches the dimensions of the form stable, highly cohesive gel breast implant. If the breast pocket is round or too loose, the form stable, highly cohesive gel breast implant may not maintain a proper position within the breast pocket and the proper breast shape will noticeably be lost.
Referring to
The trimmed extension portion 120 (1100) may be implanted submuscularly into the patient during the first surgery of the two staged breast reconstruction. After the tissue expander 105 has been inflated over time to create the appropriately expanded breast pocket, the trimmed extension portion 120 (1100) may be removed from the breast pocket and exchanged for the highly cohesive gel breast implant 1110 during the second surgery. The breast pocket created by the trimmed extension portion 120 (1100) may reduce or prevent the need for further modification of the breast pocket during the second surgery for the implantation of the form stable, highly cohesive gel breast implant 1110 into the tight breast pocket.
In various embodiments, the guideline 1105 may comprise a virtual line, an imprinted line, a crease, and/or a perforation. In one embodiment, the surgeon may simply measure the dimensions of the final implant and trim the extension portion 120 accordingly along a virtual guideline 1105. In another embodiment, the guideline 1105 may comprise an imprinted line embedded in the extension portion 120 that may correspond to the dimensions of one or more preselected form stable, highly cohesive gel breast implants 1110. In yet another embodiment, the guideline 1105 may comprise a crease or perforation that the surgeon can quickly and easily sever during surgery such as by hand or with surgical scissors. In yet another embodiment, the extension portion 120 may be pre-trimmed to the dimensions of a preselected final breast implant, such as the form stable, highly cohesive gel breast implant 1110, obviating the need for any trimming of the extension portion 120 by the surgeon.
In various embodiments, the extended tissue expander 100 may be disposed into the breast pocket 1000, wherein the breast pocket 1000 is located in any suitable anatomic soft tissue plane in the breast area 1005. In one embodiment, as shown in
In some embodiments, the extended tissue expander 100 may be used to expand the breast pocket in preparation for the second surgery in which the patient receives a tissue flap for breast reconstruction instead of the final breast implant (not shown). In a tissue flap surgery, the patient's own skin, fat, and/or muscle from another part of their body may be removed for use in reconstructing the breast or gradually moved to the breast area without severing the flap's blood supply. In one embodiment, the tissue flap may comprise skin and tissue taken from another part of the patient's body for use in reconstruction of the breast, such as a deep inferior epigastric artery perforator (DIEP) flap, a superior gluteal artery perforator (SGAP) flap, or an inferior gluteal artery perforator (IGAP) flap. In another embodiment, the tissue flap may comprise muscle in addition to skin and tissue taken from another part of the patient's body, such as a transverse rectus abdominus muscle (TRAM) flap.
In the foregoing description, the invention has been described with reference to specific exemplary embodiments. Various modifications and changes may be made, however, without departing from the scope of the present invention as set forth. The description and figures are to be regarded in an illustrative manner, rather than a restrictive one and all such modifications are intended to be included within the scope of the present invention. Accordingly, the scope of the invention should be determined by the generic embodiments described and their legal equivalents rather than by merely the specific examples described above. For example, the steps recited in any method or process embodiment may be executed in any appropriate order and are not limited to the explicit order presented in the specific examples. Additionally, the components and/or elements recited in any system embodiment may be combined in a variety of permutations to produce substantially the same result as the present invention and are accordingly not limited to the specific configuration recited in the specific examples.
Benefits, other advantages and solutions to problems have been described above with regard to particular embodiments. Any benefit, advantage, solution to problems or any element that may cause any particular benefit, advantage or solution to occur or to become more pronounced, however, is not to be construed as a critical, required or essential feature or component.
The terms “comprises”, “comprising”, or any variation thereof, are intended to reference a non-exclusive inclusion, such that a process, method, article, composition, system, or apparatus that comprises a list of elements does not include only those elements recited, but may also include other elements not expressly listed or inherent to such process, method, article, composition, system, or apparatus. Other combinations and/or modifications of the above-described structures, arrangements, applications, proportions, elements, materials or components used in the practice of the present invention, in addition to those not specifically recited, may be varied or otherwise particularly adapted to specific environments, manufacturing specifications, design parameters or other operating requirements without departing from the general principles of the same.
The present invention has been described above with reference to an exemplary embodiment. However, changes and modifications may be made to the exemplary embodiment without departing from the scope of the present invention. These and other changes or modifications are intended to be included within the scope of the present invention.
This application claims the benefit of U.S. Provisional Application No. 61/810,160, filed Apr. 9, 2013, and incorporates the disclosure of such application in its entirety by reference. To the extent that the present disclosure conflicts with the referenced application, however, the present disclosure is to be given priority.
