# US 2016/0256259 A1 · Tissue grafts with fenestrations

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- Number: US 2016/0256259 A1
- Document ID: US20160256259A1
- Status: Published application
- Kind: A1
- Application number: 15/032,567
- Filed: 2014-10-27
- Published: 2016-09-08
- Earliest claimed: 2013-10-28
- Assignees: The Regents of the University of California
- Applicants: The Regents of the University of California
- Inventors: Garrett A. Wirth; Keyianoosh Z. Paydar; Patrick Guidotti; Donald S. Mowlds
- Web page: https://patentgrep.com/patent/US20160256259A1

## CPC

- A61F 2/12: Mammary prostheses
- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- A61L 27/3633: {Extracellular matrix [ECM]}
- A61F 2230/0019: rectangular
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61L 27/36: containing ingredients of undetermined constitution or reaction products thereof {, e.g. transplant tissue, natural bone, extracellular matrix (isolated natural compounds, e.g. collagen A61L27/24)}
- A61L 2430/04: for mammary reconstruction
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Fenestrated tissue grafts and acellular dermal matrices (ADMs) for use, for example, in breast reconstruction, are disclosed herein. In various embodiments, the improved tissue grafts are used in two-stage tissue expander breast reconstruction. Disclosed embodiments include altered ADMs and other tissue grafts, which comprise strategically placed fenestrations, and methods of making the same. The addition of specific patterns of fenestrations in the graft improve the breast reconstructive experience by increasing intra-operative fill volume and decreasing time to full expansion; such alterations to the graft may also increase cosmetic outcomes and patient comfort. In some embodiments, particular lengths, shapes, and measurements of overlap are used in the fenestration pattern.

## Claims

### Claim 1

A tissue graft comprising:
a plurality of rows of fenestrations formed therein, comprising:
a first row of fenestrations aligned along a first axis; and
a second row of fenestrations aligned along a second axis;
wherein the first row of fenestrations is substantially parallel to, and substantially laterally offset from, the second row of fenestrations.

### Claim 2 (depends on 1)

The tissue graft of claim 1, wherein 20-90% of the length of a first row fenestration overlaps one or more second row fenestrations.

### Claim 3 (depends on 1)

The tissue graft of claim 1, wherein 20-90% of the length of a second row fenestration overlaps one or more first row fenestrations.

### Claim 4 (depends on 1)

The tissue graft of claim 1, wherein the plurality of rows further comprises one or more additional rows of fenestrations formed within the tissue graft.

### Claim 5 (depends on 4)

The tissue graft of claim 4, wherein the plurality of rows consists of three rows of fenestrations.

### Claim 6 (depends on 4)

The tissue graft of claim 4, wherein the plurality of rows consists of four rows of fenestrations.

### Claim 7 (depends on 1)

The tissue graft of claim 1, wherein the plurality of rows are equally spaced along an entire width of the tissue graft.

### Claim 8 (depends on 7)

The tissue graft of claim 7, wherein each fenestration in the first row of fenestrations has a length of 2.1-2.9 cm.

### Claim 9 (depends on 7)

The tissue graft of claim 7, wherein each fenestration in the second row of fenestrations has a length of 2.5-3.3 cm.

### Claim 10 (depends on 1)

The tissue graft of claim 1, wherein the plurality of rows are concentrated within a caudal half of the tissue graft.

### Claim 11 (depends on 1)

The tissue graft of claim 1, wherein the plurality of rows are equally spaced along a caudal half of the tissue graft.

### Claim 12 (depends on 11)

The tissue graft of claim 11, wherein each fenestration in the first row of fenestrations has a length of 1.8-2.3 cm.

### Claim 13 (depends on 11)

The tissue graft of claim 11, wherein each fenestration in the second row of fenestrations has a length of 3.0-4.0 cm.

### Claim 14 (depends on 1)

The tissue graft of claim 1, wherein the graft is an autograft, allograft, xenograft, engineered graft or synthetic graft.

### Claim 15 (depends on 1)

The tissue graft of claim 1, wherein the graft comprises an acellular dermal matrix.

### Claim 16 (depends on 1)

The tissue graft of claim 1, wherein the first and second rows of fenestrations are substantially parallel to a cephalic or caudal perimeter of the tissue graft.

### Claim 17 (depends on 1)

The tissue graft of claim 1, further comprising alignment perforations positioned along a perimeter of the tissue graft.

### Claim 18

A tissue graft for reconstruction of a breast, the tissue graft configured to achieve desired expansion of the breast's inferior pole following attachment to a chest wall, wherein the tissue graft comprises a plurality of fenestrations disposed therein, the fenestrations causing a decrease in the effective Young's modulus of the tissue graft, and consequently yielding a larger deflection profile in accordance with the following equation:
{
-
∂
y

(
σ


∂
y

u
)
=
f
,
y
∈
(
0
,
l
)
,
u

(
0
)
=
0
,
u

(
l
)
=
0
,
wherein u denotes the deflection profile of the tissue graft from an unstressed state, σ denotes the effective Young's Modulus, f denotes a load stemming from a breast implant positioned against the chest wall, y denotes a distance from the chest wall in a posteroanterior direction, and l denotes a distance from a suture point on the chest wall to a point of attachment at a pectoralis major muscle.

### Claim 19 (depends on 18)

The tissue graft of claim 18, wherein upon implantation, the fenestrations are positioned perpendicular to a posteroanterior line extending directly off a chest wall or parallel to the chest wall.

### Claim 20 (depends on 18)

The tissue graft of claim 18, wherein the fenestrations are positioned within a plurality of rows, and the rows are equally spaced along an entire width of the tissue graft.

### Claim 21

A tissue graft for reconstruction of a breast, the tissue graft configured to achieve desired expansion of the breast's inferior pole following attachment to a chest wall, wherein the tissue graft comprises a plurality of fenestrations disposed therein, the fenestrations concentrated in a cephalic portion or caudal portion of the tissue graft such that the tissue graft has an inhomogeneous Young's modulus profile in accordance with the following equation:
σ(y)=a+(1−a)[1+tan h(10(x−0.5))]/2
wherein σ (y) denotes a local effective Young's modulus profile across a length y of the tissue graft, a represents a targeted effective Young's modulus of the fenestrated portion of the tissue graft, h denotes a width of the tissue graft along which fenestrations are disposed, and x denotes a location along h.
