# US 10,245,117 B2 · Tissue expanders, implants, and methods of use

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- Number: US 10,245,117 B2
- Document ID: US10245117B2
- Status: Granted
- Kind: B2
- Application number: 15/389,222
- Filed: 2016-12-22
- Published: 2017-06-15
- Granted: 2019-04-02
- Earliest claimed: 2013-02-21
- Assignees: AirXpanders, Inc.
- Applicants: AirXpanders, Inc.
- Inventors: F. Mark Payne; Ryan S. Han; Jacob Jay Rice; Eadon Jacobs; Scott Allen Dodson
- Web page: https://patentgrep.com/patent/US10245117B2

## 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
- A61B 2017/00212: {using remote controls}
- A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves}
- A61B 2017/00792: {Plastic surgery}
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2250/0002: for data transfer
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61F 2250/0004: adjustable
- 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)

## Abstract

Tissue expanders and methods of use. In some embodiments the tissue expanders are adapted to reduce wear on one or more components.

## Claims

### Claim 1

A tissue expander comprising:
an implantable portion comprising a fluid source in communication with an expandable chamber, wherein the expandable chamber includes an anterior portion, wherein the anterior portion includes a first deformable member and a second deformable member, wherein the first deformable member is disposed within the second deformable member, and the first deformable member has a thickness that is about 1.5 to about 8 times the thickness of the second deformable member.

### Claim 2 (depends on 1)

The tissue expander of claim 1 wherein the first deformable member at least partially defines the expandable chamber.

### Claim 3 (depends on 2)

The tissue expander of claim 2 wherein the second deformable member is configured as a barrier layer to the fluid.

### Claim 4 (depends on 1)

The tissue expander of claim 1 further comprising an outer shell disposed at least partially around the first and second deformable members.

### Claim 5 (depends on 4)

The tissue expander of claim 4 wherein the outer shell is an elastic shell.

### Claim 6 (depends on 1)

The tissue expander of claim 1 wherein the first deformable member has a pre-formed configuration.

### Claim 7 (depends on 6)

The tissue expander of claim 6 wherein the first deformable member comprises an inelastic material with the pre-formed configuration.

### Claim 8 (depends on 6)

The tissue expander of claim 6 wherein the second deformable member has a pre-formed configuration.

### Claim 9 (depends on 8)

The tissue expander of claim 8 wherein the first and second deformable members have pre-formed configurations that are substantially the same.

### Claim 10 (depends on 1)

The tissue expander of claim 1 wherein the first and second deformable members are thin-walled deformable members.

### Claim 11 (depends on 10)

The tissue expander of claim 10 wherein the first deformable member has a thickness between about 75 microns and about 150 microns.

### Claim 12 (depends on 11)

The tissue expander of claim 11 wherein the second deformable member has a thickness between about 25 microns and about 75 microns.

### Claim 13 (depends on 10)

The tissue expander of claim 10 wherein the second deformable member has a thickness between about 25 microns and about 75 microns.

### Claim 14

A tissue expander comprising:
an implantable portion comprising a fluid source in communication with an expandable chamber, wherein the expandable chamber includes an anterior portion, wherein the anterior portion includes a first deformable member and a second deformable member, wherein the first deformable member is disposed within the second deformable member, and the first deformable member has a thickness between about 75 microns and about 150 microns.

### Claim 15 (depends on 1)

The tissue expander of claim 1 wherein at least one of the first and second deformable members comprises multiple layers of material secured together.

### Claim 16 (depends on 1)

The tissue expander of claim 1, further comprising a lubricious material disposed between the first and second deformable members to reduce friction between the first and second deformable members, wherein the lubricious material has a viscosity of at least 50 cP.

### Claim 17 (depends on 16)

The tissue expander of claim 16 wherein the lubricious material is a biocompatible lubricant.

### Claim 18 (depends on 17)

The tissue expander of claim 17 wherein the biocompatible lubricant is a silicone-based lubricant.

### Claim 19 (depends on 1)

The tissue expander of claim 1 wherein the first deformable members is attached directly to the second deformable member.

### Claim 20 (depends on 19)

The tissue expander of claim 19 wherein the first and second deformable members are secured to each other at respective peripheries of the first and second deformable members.

### Claim 21 (depends on 1)

The tissue expander of claim 1 wherein the expandable chamber includes a posterior backing coupled to the first deformable member.

### Claim 22 (depends on 1)

The tissue expander of claim 1 wherein the first deformable member has a communication component secured to it, wherein the communication component is configured for wireless communication with an external controller.

### Claim 23 (depends on 16)

The tissue expander of claim 16 wherein the volume of lubricious material disposed between the first and second members is between about 0.5 mL and about 2.5 mL.

### Claim 24 (depends on 23)

The tissue expander of claim 23 wherein the volume of lubricious material disposed between the first and second members is between about 0.5 mL and about 2.0 mL.

### Claim 25 (depends on 1)

The tissue expander of claim 1 further comprising an external controller adapted to be in communication with the implantable portion to enable fluid to be released from the fluid source into the expandable chamber.

### Claim 26 (depends on 16)

The tissue expander of claim 16 wherein the lubricious material comprises a coating on at least one of the two members.

### Claim 27 (depends on 16)

The tissue expander of claim 16 wherein the lubricous material provides substantially no additional thickness to the implantable portion.

### Claim 28

A tissue expander comprising:
an implantable portion including
an expandable chamber in fluid communication with a fluid source;
a first deformable member at least partially defining the expandable chamber and having a pre-formed configuration;
a second deformable member disposed about the first deformable member, wherein the second deformable member has a pre-formed configuration; and
an outer elastic shell disposed about the first and second deformable members.

### Claim 29 (depends on 28)

The tissue expander of claim 28 wherein the first and second pre-formed configurations are substantially the same.

### Claim 30 (depends on 28)

The tissue expander of claim 28 wherein the first and second deformable members form at least part of a gas barrier layer of the implantable portion that is substantially impermeable to fluid in the fluid source.

### Claim 31 (depends on 28)

The tissue expander of claim 28 wherein the first and second deformable members are thin-walled deformable members.

### Claim 32 (depends on 28)

The tissue expander of claim 28 wherein the first deformable member is disposed inside the second deformable member, and the first deformable member has a thickness between about 75 microns and about 150 microns.

### Claim 33 (depends on 32)

The tissue expander of claim 32 wherein the second deformable member has a thickness between about 25 microns and about 75 microns.

### Claim 34 (depends on 28)

The tissue expander of claim 28 wherein the first deformable member is disposed inside the second deformable member, and the second deformable member has a thickness between about 25 microns and about 75 microns.

### Claim 35 (depends on 28)

The tissue expander of claim 28 wherein the first deformable member is disposed inside the second deformable member, and the first deformable member has a thickness that is about 1.5 to about 8 times the thickness of the second deformable member.

### Claim 36

A tissue expander comprising:
an implantable portion comprising a fluid source in fluid communication with an expandable chamber, a communication element secured to the expandable chamber and movable relative to the expandable chamber, wherein the communication element is disposed inside a pocket, and the pocket is attached to the expandable chamber, and wherein the communication element is secured inside the pocket such that it floats inside the pocket.

### Claim 37 (depends on 36)

The tissue expander of claim 36 wherein the communication element is an antenna.

### Claim 38 (depends on 36)

The tissue expander of claim 36 wherein the communication element is stiffer than the expandable chamber.

### Claim 39 (depends on 36)

The tissue expander of claim 36 wherein the expandable chamber has a thickness between about 50 microns and about 150 microns.

### Claim 40 (depends on 36)

The tissue expander of claim 36 wherein two side of the pocket are attached together at a plurality of discrete locations with at least one unattached location between the two sides.

### Claim 41

A tissue expander comprising:
an implantable portion comprising a fluid source in fluid communication with an expandable chamber, a communication element secured to the expandable chamber and movable relative to the expandable chamber, wherein the communication element is disposed inside a pocket, and wherein the pocket is attached to the expandable chamber at a plurality of discrete locations with at least one unattached location where the pocket is not attached to the expandable chamber.

### Claim 42 (depends on 41)

The tissue expander of claim 41 wherein the pocket is secured to the expandable chamber around a periphery of the pocket at at least three locations with unsecured locations where the pocket is not attached to the expandable chamber.

### Claim 43 (depends on 36)

The tissue expander of claim 36 wherein the communication element is secured to a first portion of the expandable chamber that, in a side view of an expanded configuration of the expandable chamber, is less curved than a second portion of the expandable chamber.

### Claim 44 (depends on 36)

The tissue expander of claim 36 wherein the expandable chamber comprises an inelastic material with a preformed expanded configuration, and the communication element is secured to the inelastic material such that it can move relative to the inelastic material.
