# US 11,065,075 B2 · Systems and methods for a tissue expander

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- Number: US 11,065,075 B2
- Document ID: US11065075B2
- Status: Granted
- Kind: B2
- Application number: 16/879,674
- Filed: 2020-05-20
- Published: 2020-11-26
- Granted: 2021-07-20
- Earliest claimed: 2019-05-20
- Assignees: Reconstructive Technologies, LLC
- Applicants: Reconstructive Technologies, LLC
- Inventors: Tamir Mostafa Mosharrafa
- Web page: https://patentgrep.com/patent/US11065075B2

## CPC

- 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 2/12: Mammary prostheses
- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61F 2250/0031: made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
- A61F 2250/0059: temporary
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- 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)}

## Abstract

Systems and methods for an extended tissue expander according to various aspects of the present technology may function in conjunction with a graft material for temporary implantation into a patient to form a pocket for a permanent implant. Systems and methods may comprise an extended tissue expander comprising an extension portion that may be integral to a posterior section of a shell of the extended tissue expander, wherein the extension portion extends from the posterior section forming an at least partially continuous annular rim around the circumference of the shell. The graft material may overlay an anterior portion of the shell and may be coupled to the at least partially continuous annular rim with bioabsorbable sutures. Upon implantation, the shell may be partially filled with a filler material until the graft material is gently pressed against a posterior portion of the patient skin flap, promoting its integration.

## 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:
is integral to the posterior section of the shell, extending therefrom as a partially continuous annular rim, wherein the annular rim is absent from only approximately twenty percent to approximately forty percent of an inferior pole of the shell such that at least one of a medial and a lateral portion of the extension portion is present below a horizontal midline of the shell;
has a substantially uniform thickness;
is substantially nonexpandable to provide a backing to the shell such that the shell expands anteriorly away from the chest wall upon filling with filler material; and
is configured to be sutured.

### Claim 2 (depends on 1)

The extended tissue expander of claim 1, wherein the extension portion comprises a single piece of silicone.

### Claim 3 (depends on 2)

The extended tissue expander of claim 2, wherein the extension portion further comprises a reinforcement material embedded into the single piece of silicone, enhancing the resilience of the silicone.

### Claim 4 (depends on 3)

The extended tissue expander of claim 3, wherein the reinforcement material is a suturable surgical fabric.

### Claim 5 (depends on 1)

The extended tissue expander of claim 1, wherein the partially continuous annular rim is up to approximately three centimeters wide.

### Claim 6 (depends on 1)

The extended tissue expander of claim 1, further comprising a graft material coupled to the partially continuous annular rim, wherein the graft material overlays an anterior portion of the shell.

### Claim 7 (depends on 6)

The extended tissue expander of claim 6, wherein the graft material is sutured to the partially continuous annular rim with a bioabsorbable suture placed through the graft and at least one of a superior, lateral, and medial portion of the partially continuous annular rim.

### Claim 8 (depends on 6)

The extended tissue expander of claim 6, wherein the graft material overlays the anterior portion of the shell to contact and integrate into a posterior portion of a skin flap of the patient.

### Claim 9

A method for forming a final encapsulated breast pocket with a graft material integrated into a posterior portion of a patient's skin flap, comprising:
forming an initial breast pocket in a breast area of the patient;
inserting an extended breast tissue expander into the initial breast pocket, comprising:
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 posterior section comprises an integrated portion of the shell; and
a port disposed through the shell and into the interior volume;
an extension portion coupled to the breast tissue expander, wherein the extension portion:
is integral to the posterior section of the shell, extending therefrom as a partially continuous annular rim, wherein the partially continuous annular rim is absent from only approximately twenty percent to approximately forty percent of an inferior pole of the shell such that at least one of a medial and a lateral portion of the extension portion is present below a horizontal midline of the shell;
has a substantially uniform thickness;
is substantially nonexpandable to provide a backing to the shell such that
the shell expands anteriorly away from the chest wall upon filling with the filler material; and
is configured to be sutured; and
a graft material coupled to the partially continuous annular rim, wherein the graft material overlays an anterior portion of the shell to contact and integrate into a the posterior portion of the skin flap;
suturing the partially continuous annular rim to at least one of an underlying muscle fascia and a chest wall fascia of the patient; and
at least partially inflating the shell with the filler material to press the graft material against the posterior portion of the skin flap.

### Claim 10 (depends on 9)

The method of claim 9, wherein the graft material is sutured to the partially continuous annular rim with a bioabsorbable suture placed through the graft and at least one of a superior, lateral, medial, and inferior portion of the partially continuous annular rim.

### Claim 11 (depends on 9)

The method of claim 9, further comprising tucking a lower portion of the graft material under the shell and behind the partially continuous annular rim and suturing the graft material to at least one of the patient's underlying muscle fascia and chest wall fascia to create a sling for the shell to rest in.

### Claim 12 (depends on 9)

The method of claim 9, wherein the at least partially continuous annular rim is up to approximately three centimeters wide.

### Claim 13 (depends on 9)

The method of claim 9, wherein the extension portion comprises silicon with an embedded reinforcement material configured to enhance the resilience of the silicone.

### Claim 14 (depends on 13)

The method of claim 13, wherein the reinforcement material is a suturable surgical fabric.

### Claim 15 (depends on 9)

The method of claim 9, wherein the initial breast pocket is subcutaneous.

### Claim 16 (depends on 15)

The method of claim 15, further comprising suturing an anterior face of the graft material to the posterior portion of the skin flap overlaying the initial breast pocket to maintain the position of a nipple.

### Claim 17 (depends on 9)

The method of claim 9, wherein the initial breast pocket is submuscular.
