WO2014168926A1 - Systèmes et procédés pour un expanseur tissulaire - Google Patents

Systèmes et procédés pour un expanseur tissulaire Download PDF

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Publication number
WO2014168926A1
WO2014168926A1 PCT/US2014/033291 US2014033291W WO2014168926A1 WO 2014168926 A1 WO2014168926 A1 WO 2014168926A1 US 2014033291 W US2014033291 W US 2014033291W WO 2014168926 A1 WO2014168926 A1 WO 2014168926A1
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WO
WIPO (PCT)
Prior art keywords
breast
tissue expander
extended
extension portion
pocket
Prior art date
Application number
PCT/US2014/033291
Other languages
English (en)
Inventor
Tamir M. MOSHARRAFA
Ali M. MOSHARRAFA
Original Assignee
Reconstructive Technologies, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/948,067 external-priority patent/US20150025563A1/en
Application filed by Reconstructive Technologies, Llc filed Critical Reconstructive Technologies, Llc
Publication of WO2014168926A1 publication Critical patent/WO2014168926A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02—Devices for expanding tissue, e.g. skin tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses and implants

Definitions

  • TITLE SYSTEMS AND METHODS FOR A TISSUE EXPANDER
  • 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.
  • 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.
  • the 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Figures 1A-1B representatively illustrate an anterior view of an extended tissue expander comprising an extension portion that completely covers and extends beyond a posterior surface of a tissue expander;
  • Figures 2A-2B representatively illustrate a side view of the extended tissue expander comprising the extension portion that completely covers and extends beyond the posterior surface of the tissue expander;
  • Figure 3 representatively illustrates a posterior view of the extended tissue expander comprising the extension portion that completely covers and extends beyond the posterior surface of the tissue expander;
  • Figure 4 representatively illustrates an anterior view of an extended tissue expander comprising an extension portion that partially covers a posterior surface of a tissue expander
  • Figure 5 representatively illustrates a side view of the extended tissue expander comprising the extension portion that partially covers the posterior surface of the tissue expander;
  • Figure 6 representatively illustrates a posterior view of the extended tissue expander comprising the extension portion that partially covers the posterior surface of the tissue expander
  • Figure 7 representatively illustrates a side view of an extended tissue expander comprising an extension portion that extends upward from an upper boundary of a tissue expander
  • Figure 8 representatively illustrates a posterior view of an extended tissue expander comprising the extension portion that extends upward from the upper boundary of the tissue expander
  • Figure 9 representatively illustrates an exemplary extended tissue expander disposed within a breast pocket of a patient
  • Figures 1 OA- IOC representatively illustrate side views of an extended tissue expander disposed within a breast pocket of a patient after mastectomy and subsequently expanded in the breast pocket;
  • Figures 11A-11C representatively illustrate the modification of an extended tissue expander along a guideline to match the dimensions of a form stable, highly cohesive silicon gel breast implant, shown with anterior views;
  • Figures 12A-12C representatively illustrate the modification of the extended tissue expander along the guideline to match the dimensions of the form stable, highly cohesive silicon gel breast implant, shown with side views;
  • Figure 13 representatively illustrates a method of using an extended tissue expander.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • the extended tissue expander may be implanted during a first surgery of a two staged breast reconstruction surgery.
  • 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.
  • exemplary embodiments of the extended tissue expander 100 may comprise an inflatable tissue expander 105 coupled to an extension portion 120.
  • the tissue expander 105 may comprise any suitable system or device for affecting breast tissue and skin expansion or stretching.
  • the tissue expander 105 may comprise an inflatable balloon constructed from silicone elastomer or polypropylene.
  • the tissue expander 105 may further comprise a self-sealing integral injection port 110, such as a septum, that may be pierced with a hypodermic needle to introduce the filler material into a lumen of the tissue expander 105 for inflation.
  • the injection port 110 may be located remotely from the tissue expander 105.
  • the injection port 110 may be coupled to the tissue expander 105 through a tubing (not shown) to allow the filler material to flow from the injection port 110 into the lumen of the tissue expander 105.
  • 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 Mentor Contour Profile ® Tissue Expander.
  • the tissue expander 105 may comprise a shape that provides directional expansion to at least a portion of the breast pocket.
  • 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.
  • the directionally expanding tissue expander 105 may comprise or be similar to the textured or smooth crescent tissue expanders from Sientra ® .
  • the directionally expanding tissue expander 105 may comprise or be similar to the Sientra ® ACXTM double chamber anatomical controlled breast tissue expander which may be configured for differential inflation of one or both chambers.
  • the tissue expander 105 may be configured to create a full breast shaped breast pocket.
  • the tissue expander 105 may comprise or be similar to any of the Mentor ® CPX2TM, CPX3TM, or CPXTM 4 breast tissue expanders in a low, medium, or tall height.
  • the tissue expander 105 may comprise or be similar to Allergan Natrelle ® 133 Tissue Expanders.
  • 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.
  • the tissue expander 105 may comprise one or more suture tabs 410.
  • the suture tabs 410 may be coupled to the tissue expander 105 and configured to anchor the submuscular position of the tissue expander 105 by allowing the surgeon to suture the suture tabs 410 to fascia, or other native tissues, on the patient's chest wall and/or other underlying tissue to prevent migration and/or rotation of the tissue expander 105.
  • the suture tabs 410 may comprise an elastomer such as silicone elastomer (sometimes referred to as silicone rubber).
  • the suture tabs 410 may be reinforced with any biocompatible nonbioabsorbable surgical fabric such as Dacron mesh and/or nylon.
  • the suture tabs 410 may be securely coupled to the tissue expander 105 by any suitable method.
  • the suture tabs 410 may be coupled to the tissue expander 105 with a biocompatible adhesive such as a silicone adhesive.
  • the suture tabs 410 may be coextruded with the tissue expander 105.
  • the suture tabs 410 may be incorporated into a mold for creating the tissue expander 105.
  • 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.
  • the surface texture 115 may support immobility of the tissue expander 105 within the breast pocket during expansion of the tissue expander 105.
  • the surface texture 115 may reduce the incidence of adverse capsular contracture that may cause deformation of the tissue expander 105.
  • the surface texture 115 of the tissue expander 105 may comprise raised microscale nodules providing a rough feel.
  • the Mentor ® tissue expanders described above may comprise SILTEX ® surface texturing having microscale nodules.
  • the surface texture 115 of the tissue expander 105 may comprise surface depressions.
  • 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.
  • the fibrous capsule may form around both the extension portion 120 and the tissue expander 105 to form a teardrop shaped breast pocket.
  • the extension portion 120 may have a uniform thickness.
  • the position of the extension portion 120 may be static in relation to the tissue expander 105.
  • the extension portion 120 may be configured to be sutured to tissue on the patient's chest wall.
  • At least one dimension of the extension portion is
  • 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.
  • 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.
  • 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.
  • ADM's acellular dermal matrix
  • the 100 may comprise the extension portion 120.
  • the extension portion 120 may be disposed along a posterior surface of the tissue expander 105 such that the length and width of the extension portion 120 exceeds the length and width of the posterior surface of the tissue expander 105.
  • an upper portion 130 of the extension portion 120 may be sufficiently long to extend up to at least about the patient's second rib and/or the upper portion 130 may be at least twice the height of the tissue expander 105.
  • a posterior view of the extended tissue expander 100 is illustrated in which the extension portion 120 covers an area greater than the posterior surface of the tissue expander 105. As a result, the tissue expander 105 may not be visible from the posterior view of the extended tissue expander 100.
  • 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 tissue on the patient's chest wall to prevent migration and/or rotation of the extended tissue expander 100 in the breast pocket.
  • 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.
  • 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.
  • an extension portion 120 may be disposed along the posterior surface of the tissue expander 105 such that the extension portion 120 covers less than the entire posterior surface of the tissue expander 105. As shown in Figure 6, at least a portion of a posterior surface 615 of the tissue expander 105 may be visible from the posterior view when the tissue expander 105 is coupled to the extension portion 120. In one embodiment, the upper portion 130 of the extension portion 120 may be sufficiently long to extend up to at least about the patient's second rib and/or the upper portion 130 may be at least twice the height of the tissue expander 105.
  • the upper portion 130 of the extension portion 120 may provide the surgeon with ample material for suturing the extended tissue expander 100 to tissue 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 tissue. 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.
  • the extension portion 120 may be disposed along an upper boundary 125 of the tissue expander 105 and extend upwards from the tissue expander 105. In one embodiment, the entire posterior surface 615 of the tissue expander 105 may be exposed. In one embodiment, the upper portion 130 of the extension portion 120 may be sufficiently long to extend up to at least about the patient's second rib and/or the upper portion 130 may be at least twice the height of the tissue expander 105. The extension portion 120 in this embodiment may only extend from the upper boundary 125 of the tissue expander 105. Therefore, the extension portion 120 may not provide lateral and/or inferior material for suturing the extended tissue expander 100 to the tissue. 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 tissue.
  • 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.
  • 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.
  • the extension portion 120 may comprise a sheet of silicone elastomer or polypropylene.
  • the extension portion 120 may comprise a smooth surface, any appropriate textured surface, or a combination thereof.
  • 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.
  • 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.
  • the upper portion 130 may be trimmed to extend the breast pocket from the upper boundary 125 of the tissue expander 105 to at least the patient's second rib to maintain an extended open pocket above the tissue expander 105.
  • the extended tissue expander 100 may be provided with an oversized untrimmed upper portion 130 of the extension portion 120 that may accommodate any patient's height.
  • the height of the upper portion 130 may be longer than the distance between the top of any patient's breast and clavicle.
  • the untrimmed upper portion 130 may be at least fifteen centimeters.
  • 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.
  • the untrimmed upper portion 130 may be 10 centimeters for a petite patient or 15 centimeters for a tall patient.
  • the untrimmed upper portion 130 may be at least twice the height of the tissue expander 105.
  • 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.
  • an exemplary extension portion 120 may further comprise a surgical fabric 135 that may be imbedded in an inner portion or attached to the extension portion 120.
  • the surgical fabric 135 may comprise any suitable biocompatible, nonbioabsorbable, non-immunogenic, and/or inert surgical fabric configured to provide reinforcement and/or improved mechanical integrity to the silicon elastomer of the extension portion 120.
  • the surgical fabric 135 may prevent ripping or damage to the extension portion 120 upon suturing the extension portion 120 to tissue on the patient's chest wall and/or as the extended tissue expander 100 moves within the breast pocket.
  • the surgical fabric 135 may comprise any natural or synthetic material that is biologically compatible with soft tissue and insoluble in body fluids.
  • the surgical fabric 135 may comprise a nonbioabsorbable polymer such as knitted or woven Dacron ® mesh (polyethylene terephthalate).
  • the surgical fabric 135 may be fabricated from polymers such as polyethylene, polypropylene, nylon, polytetrafluorothylene, and/or polyvinylidene fluoride.
  • the surgical fabric 135 may be embedded in or attached to the extension portion 120 by any suitable method.
  • the surgical fabric 135 may be attached to an exterior surface of the extension portion 120 (not shown) with a silicone-based adhesive.
  • the extension portion 120 may be coextruded with the surgical fabric 135.
  • the extension portion 120 may be molded around the surgical fabric 135.
  • 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.
  • the surgical fabric 135 may occupy a substantially central portion of the extension portion 120.
  • the surgical fabric 135 may not extend to the edges of the extension portion 120 to accommodate a need to trim the extension portion 120 to a desired size and/or shape without exposing the raw edges of the surgical fabric 135 upon trimming.
  • the edges of the surgical fabric 135 may remain sealed within the extension portion 120 after trimming and may still maintain its reinforcement capability for suturing.
  • the extension portion 120 may be coupled to the tissue expander 105 by any suitable method.
  • 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.
  • the extension portion 120 may be coupled directly to the tissue expander 105 with an adhesive such as a silicone adhesive.
  • the extension portion 120 may be coupled indirectly to the tissue expander 105.
  • the tissue expander 105 may comprise a fastener such as a press stud for attachment of the extension portion 120.
  • the extension portion 120 may be coextruded or included as part of a mold for the tissue expander 105.
  • the extension portion 120 and the tissue expander 105 may comprise a single continuous device.
  • 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.
  • the extension portion 120 may be trimmed to the desired boundaries of the final encapsulated breast pocket.
  • 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.
  • 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.
  • the outer borders of the extension portion 120 may be trimmed to reach a patient's sternal border 905 medially, lateral chest wall 915 laterally, and second rib 910 superiorly.
  • the inferior border of the extension portion may vary between individual patients according to their natural or desired breast position.
  • 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.
  • 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.
  • 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.
  • 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 ® MemoryShapeTM 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.
  • 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.
  • the extension portion 120 of the extended tissue expander 100 may be trimmed to substantially exactly match the borders of a form stable, highly cohesive gel breast implant 1110.
  • the surgeon may cut the extension portion 120 along guideline 1105 which matches the height 1120 and width 1115 of the form stable, highly cohesive gel breast implant 1110.
  • Figure 11B illustrates the resulting trimmed extension portion 120 (1100) that has been cut down to the height 1120 and width 1115 of the highly cohesive gel breast implant 1110.
  • Figures 12A-C corresponds to the side views of each anterior view shown in Figures 11A-C, respectively.
  • Figures 12A-C illustrate that the trimmed extension portion 120 (1100) may result in the extended tissue expander 100 having the substantially precise dimensions of the height 1120, width 1125, and the depth 1125 of the form stable, highly cohesive gel breast implant 1110.
  • 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.
  • the guideline 1105 may comprise a virtual line, an imprinted line, a crease, and/or a perforation.
  • the surgeon may simply measure the dimensions of the final implant and trim the extension portion 120 accordingly along a virtual guideline 1105.
  • 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.
  • 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.
  • 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.
  • Figures lOA-C illustrate the formation of a breast pocket 1000 created in an exemplary first surgery of the two staged breast reconstruction.
  • Figure 10A illustrates a breast area 1005 wherein cancer affected breast tissue and skin has been removed by mastectomy.
  • Figure 10B illustrates the implantation of an exemplary extended tissue expander 100 under the pectoralis major muscle 1010 and into the breast pocket 1000 created by the surgeon.
  • the tissue expander 105 may be at least partially collapsed upon implantation during the first surgery. Accordingly, the breast pocket 1000 is not yet formed to the desired volume needed for the final breast implant.
  • 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.
  • the extended tissue expander 100 may be implanted under the pectoralis major muscle 1010.
  • the extended tissue expander 100 may be implanted above the pectoralis major muscle 1010 in the subcutaneous plane (not shown).
  • the extended tissue expander 100 may be implanted under other muscles in the chest wall 1015, such as the pectoralis minor, serratus anterior, or the latissimus dorsi (not shown).
  • 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).
  • 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.
  • 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.
  • 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.
  • TAM transverse rectus abdominus muscle
  • Figure IOC illustrates the inflated tissue expander 105 wherein the breast pocket 1000 has expanded to the desired dimensions to accommodate the final breast implant. The patient may then be ready for the second surgery to exchange the extended tissue expander 100 for the final breast implant.
  • the extension portion 120 is shown to extend an upper margin 1020 of the breast pocket 1000 (corresponding to the height of the extension portion 120, such as height 1120) without a substantial amount of anterior expansion away from the chest wall 1015.
  • Figure IOC illustrates the breast pocket 1000 having the teardrop shape created by the extended tissue expander 100.
  • Figure 13 illustrates an exemplary method of preserving an upper margin
  • a method of using the extended tissue expander 100 may comprise surgically preparing a breast pocket 1000 under the pectoralis major muscle 1010 or other suitable anatomic soft tissue plane in the breast area 1005 for implantation of the extended tissue expander 100 in the first surgery (1305).
  • the extended tissue expander 100 may comprise an extension portion 120 extending upwards past an upper boundary 125 of the tissue expander 105.
  • the extension portion 120 may be configured to preserve the upper margin 1020 of the breast pocket 1000 to form a teardrop shaped breast pocket 1000 until the second surgery of the two staged breast reconstruction.
  • the method of using the extended tissue expander 100 may further comprise trimming the outer borders of the extended tissue expander 100, such as along guideline 1105, to substantially match the desired breast pocket dimensions for the final breast implant, such as wherein the final breast implant is a form stable, highly cohesive gel breast implant (1310).
  • the outer borders of the extended tissue expander 100 may be trimmed to substantially match the desired boundaries of the final encapsulated breast pocket for use with a smooth or textured round final breast implant.
  • the trimmed extended tissue expander 100 may be disposed within the breast pocket 1000 with the tissue expander 105 at least partially collapsed (1315).
  • the trimmed extension portion 120 may be sutured to the tissue on the patient's chest wall to secure and stabilize the position of the extended tissue expander 100 in the breast pocket 1000 (1320).
  • the tissue expander 105 may be filled with filler material during and/or after surgery to gradually expand the tissue expander 105 over time until the breast pocket 1000 reaches a desired volume to accommodate the final breast implant (1325).
  • the extended tissue expander 100 may then be exchanged with the final breast implant without further surgical modification of the breast pocket 1000 (1330).

Abstract

Divers modes de réalisation concernent des systèmes et des procédés pour un expanseur tissulaire étendu temporaire. Des systèmes et des procédés selon divers aspects de la présente invention peuvent comprendre un expanseur tissulaire étendu configuré pour accroître et/ou personnaliser la dimension et/ou la forme d'une poche de tissu au-delà de la dimension et/ou la forme fournies par un expanseur tissulaire classique. L'expanseur tissulaire étendu peut comprendre un expanseur tissulaire couplé à une partie extension. Dans un premier mode de réalisation, l'expanseur tissulaire étendu peut fournir à une poche de poitrine une forme de goutte souhaitée qui ne nécessite pas de modification chirurgicale importante avant le placement d'un implant mammaire final ou d'un lambeau de tissu. Dans un autre mode de réalisation, l'expanseur tissulaire étendu peut être modifié aux dimensions précises d'un implant mammaire final pour l'échange simple de l'expanseur tissulaire étendu pour l'implant mammaire final.
PCT/US2014/033291 2013-04-09 2014-04-08 Systèmes et procédés pour un expanseur tissulaire WO2014168926A1 (fr)

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US201361810160P 2013-04-09 2013-04-09
US61/810,160 2013-04-09
US13/948,067 2013-07-22
US13/948,067 US20150025563A1 (en) 2013-07-22 2013-07-22 Systems and methods for a tissue expander

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107334544A (zh) * 2017-02-13 2017-11-10 上海威宁整形制品有限公司 一种应用激光扫描、有限元分析和3d打印技术定制符合生物力学的扩张器的方法
US11537829B2 (en) 2016-02-09 2022-12-27 Establishment Labs S.A. Transponders and sensors for implantable medical devices and methods of use thereof
US11571271B2 (en) 2016-10-28 2023-02-07 Establishment Labs S.A. Tissue expanders and methods of use thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996040003A1 (fr) * 1995-06-07 1996-12-19 Ledergerber Walter J Dispositif d'expansion de tissus
US20070233273A1 (en) * 2003-05-26 2007-10-04 Connell Anthony F Differential Tissue Expander Implant
US20100217388A1 (en) * 2007-10-16 2010-08-26 Orbix Medical Ltd System and method for reshaping soft tissue
WO2012012636A1 (fr) * 2010-07-21 2012-01-26 Baker Hughes Incorporated Outil de forage présentant un revêtement métallique renforcé de nanoparticules

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996040003A1 (fr) * 1995-06-07 1996-12-19 Ledergerber Walter J Dispositif d'expansion de tissus
US20070233273A1 (en) * 2003-05-26 2007-10-04 Connell Anthony F Differential Tissue Expander Implant
US20100217388A1 (en) * 2007-10-16 2010-08-26 Orbix Medical Ltd System and method for reshaping soft tissue
WO2012012636A1 (fr) * 2010-07-21 2012-01-26 Baker Hughes Incorporated Outil de forage présentant un revêtement métallique renforcé de nanoparticules

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11537829B2 (en) 2016-02-09 2022-12-27 Establishment Labs S.A. Transponders and sensors for implantable medical devices and methods of use thereof
US11593601B2 (en) 2016-02-09 2023-02-28 Establishment Labs S.A. Transponders and sensors for implantable medical devices and methods of use thereof
US11571271B2 (en) 2016-10-28 2023-02-07 Establishment Labs S.A. Tissue expanders and methods of use thereof
CN107334544A (zh) * 2017-02-13 2017-11-10 上海威宁整形制品有限公司 一种应用激光扫描、有限元分析和3d打印技术定制符合生物力学的扩张器的方法

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