# US 9,399,122 B2 · Systems and methods for a tissue expander > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,399,122 B2 - Document ID: US9399122B2 - Status: Granted - Kind: B2 - Application number: 14/963,641 - Filed: 2015-12-09 - Published: 2016-03-24 - Granted: 2016-07-26 - Earliest claimed: 2013-04-09 - Assignees: Reconstructive Technologies, LLC - Applicants: Reconstructive Technologies, LLC - Inventors: Tamir M. Mosharrafa; Ali M. Mosharrafa - Web page: https://patentgrep.com/patent/US9399122B2 ## CPC - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - A61F 2/12: Mammary prostheses - A61B 90/02: {Devices for expanding tissue, e.g. skin tissue (implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00)} - A61F 2/52: Mammary prostheses (brassieres with stiffening or bust-forming inserts A41C3/10, A41C3/14) - A61F 2002/523: {Multiple breast forms made of several concentric breast-shaped layers nested into one another} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - 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 (dental prosthetics A61C) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Methods and systems for a tissue expander according to various aspects of the present invention may function in conjunction with an extended tissue expander, such as an extended tissue expander to be temporarily implanted into a patient to form a pocket for a permanent implant. 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. ## Claims ### Claim 1 An extended tissue expander for filling with a filler material and implantation in the breast area of a patient, comprising: a breast tissue expander, comprising: a shell defining a closed interior volume configured to retain the filler material, wherein the shell comprises: an expandable anterior shell; and a substantially nonexpandable posterior section, wherein the posterior section comprises an integrated portion of the shell; and a port disposed through the shell and into the interior volume; and an extension portion coupled to the breast tissue expander, wherein the extension portion: extends beyond a medial edge and a lateral edge of the breast tissue expander to a distance of less than about 10% of the height of the fully expanded breast tissue expander; and extends superiorly above an upper boundary of the fully expanded breast tissue expander to: a distance up to about 50% of the height of the fully expanded breast tissue expander, so dimensioned to reach the superior boundary of the breast area in the patient. ### Claim 2 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion extends superiorly above the upper boundary of the fully expanded breast tissue expander to a distance of about 50% of the height of the fully expanded breast tissue expander. ### Claim 3 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion extends below an inferior border of the breast tissue expander when the breast tissue expander is substantially deflated. ### Claim 4 (depends on 3) The extended tissue expander of claim 3, wherein the inferior border of the breast tissue expander is below an inferior border of the extension portion when the breast tissue expander is in an at least partially inflated state. ### Claim 5 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion comprises a substantially round shape. ### Claim 6 (depends on 1) The extended tissue expander of claim 1, wherein the thickness of the extension portion is tapered. ### Claim 7 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion has a substantially uniform thickness. ### Claim 8 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion comprises a maximum thickness of at least about 1.5 millimeters. ### Claim 9 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion has a maximum thickness of about 1.5 to about 2 millimeters. ### Claim 10 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion comprises a trimmable material. ### Claim 11 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion comprises a resilient material. ### Claim 12 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion comprises a single piece of silicone. ### Claim 13 (depends on 12) The extended tissue expander of claim 12, wherein the extension portion further comprises a reinforcement material embedded into the single piece of silicone, wherein the reinforcement material enhances a resilience of the silicone. ### Claim 14 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion comprises multiple layers of silicone. ### Claim 15 (depends on 14) The extended tissue expander of claim 14, wherein the extension portion further comprises a reinforcement material at least one of (a) embedded into one or more of the multiple layers of silicone and (b) disposed between two or more adjacent layers of silicone. ### Claim 16 (depends on 1) The extended tissue expander of claim 1, wherein the extension portion further comprises a reinforcement material. ### Claim 17 (depends on 16) The extended tissue expander of claim 16, wherein the reinforcement material comprises an embedded suturable surgical fabric. ### Claim 18 (depends on 16) The extended tissue expander of claim 16, wherein the extension portion further comprises a reinforcement material arranged in a radial pattern from a focal point in a lower pole of the extension portion and spreading outwardly toward the extension portion's outer edge. ### Claim 19 An extended tissue expander for receiving a fluid for forming a final encapsulated breast pocket within an anatomic boundary of a patient's breast area that is configured to receive a pre-selected final breast implant or a tissue flap, the extended tissue expander comprising: a breast tissue expander, comprising: a shell configured to retain the fluid, wherein the shell comprises: a substantially nonexpandable backing; an expandable anterior shell coupled to the backing, wherein the anterior shell is integrated with the nonexpandable backing and extends anteriorly therefrom; and a port disposed through the shell; wherein the shell expands anteriorly substantially evenly as the fluid is post-operatively added to the shell through the port; and an approximately round extension portion coupled to the breast tissue expander, wherein the extension portion: extends beyond a medial edge and a lateral edge of the breast tissue expander in a fully expanded state to a distance of less than about 10% of the height of the breast tissue expander in the fully expanded state; extends superiorly beyond an upper boundary of the breast tissue expander in the fully expanded state to a distance of up to about 50% of the height of the breast tissue expander in the fully expanded state, so dimensioned to reach the superior boundary of the breast area in the patient; has a substantially uniform thickness of about 1.5 to 2 millimeters; substantially resiliently resumes its round shape after bending; and maintains an extended open pocket superiorly to the breast tissue expander to substantially correlate the dimensions of the extended tissue expander to at least one of: the dimensions of the final encapsulated breast pocket that extends to the anatomic boundary of the patient's breast area; and the dimensions of the pre-selected final breast implant to provide a tight breast pocket for the pre-selected final breast implant. ### Claim 20 (depends on 19) The extended tissue expander of claim 19, wherein the pre-selected final breast implant is a form stable, highly-cohesive silicone gel breast implant. ### Claim 21 (depends on 19) The extended tissue expander of claim 19, wherein the extension portion comprises a single piece of silicone. ### Claim 22 (depends on 21) The extended tissue expander of claim 21, wherein a reinforcement material is embedded into the single piece of silicone for shape retention. ### Claim 23 (depends on 19) The extended tissue expander of claim 19, wherein the extension portion comprises multiple layers of silicone that are coupled together. ### Claim 24 (depends on 23) The extended tissue expander of claim 23, wherein a reinforcement material is at least one of (a) embedded into one or more of the multiple layers of silicone and (b) disposed between two or more adjacent layers of silicone. ### Claim 25 (depends on 19) The extended tissue expander of claim 19, wherein the extension portion further extends below an inferior border of the breast tissue expander when the breast tissue expander is in a deflated state. ### Claim 26 (depends on 25) The extended tissue expander of claim 25, wherein the inferior border of the breast tissue expander is below an inferior border of the extension portion when the breast tissue expander is in an at least partially inflated state. ### Claim 27 (depends on 19) The extended tissue expander of claim 19, wherein the extension portion further comprises a reinforcement material arranged in a radial pattern from a focal point in a lower pole of the extension portion and spreading outwardly toward the extension portion's outer edge. ### Claim 28 A method for forming a final encapsulated breast pocket within an anatomic boundary of a patient's breast area that is configured to receive a pre-selected final breast implant or a tissue flap, comprising: forming an initial breast pocket in the patient's breast area; and inserting an extended tissue expander into the initial breast pocket, wherein the extended tissue expander includes: a breast tissue expander, comprising: a shell defining a closed interior volume configured to retain a filler material, wherein the shell comprises: an expandable anterior shell; and a substantially nonexpandable posterior section, wherein the anterior shell is integrated with the posterior section and extends anteriorly therefrom; and a port disposed through the shell and into the interior volume; and an extension portion coupled to the breast tissue expander, wherein the extension portion: extends beyond a medial edge and a lateral edge of the breast tissue expander to a distance of less than about 10% of the height of the fully expanded breast tissue expander; and extends superiorly above an upper boundary of the fully expanded breast tissue expander to a distance up to about 50% of the height of the fully expanded breast tissue expander, wherein the distance of superior extension of the extension portion above the upper boundary of the fully expanded breast tissue expander corresponds to the superior boundary of the breast area in the patient. ### Claim 29 (depends on 28) The method for forming a final encapsulated breast pocket of claim 28, further comprising trimming the extension portion to fit a desired final encapsulated breast pocket. ### Claim 30 (depends on 28) The method for forming a final encapsulated breast pocket of claim 28, further comprising suturing the extension portion to the patient.