# US 10,244,818 B2 · Variable hardness orthotic

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- Number: US 10,244,818 B2
- Document ID: US10244818B2
- Status: Granted
- Kind: B2
- Application number: 15/046,661
- Filed: 2016-02-18
- Published: 2016-08-18
- Granted: 2019-04-02
- Earliest claimed: 2015-02-18
- Assignees: Clemson University Research Foundation; Ability Prosthetics & Orthotics, Inc.
- Applicants: Clemson University
- Inventors: John DesJardins; Scott Edward Stanley; Breanne Przestrzelski; Timothy C. Pruett; Steve L. Hoeffner; Brian Daryl Kaluf
- Web page: https://patentgrep.com/patent/US10244818B2

## CPC

- A43B 13/20: Pneumatic soles {filled with a compressible fluid, e.g. air, gas (inflatable linings for skiboots A43B5/0407)}
- A43B 1/0009: {made at least partially of alveolar or honeycomb material}
- A43B 7/146: {provided with acupressure points or means for foot massage}
- A43B 13/188: {Differential cushioning regions}
- A43B 17/006: {multilayered}
- A43B 17/03: filled with a gas, e.g. air
- A43B 17/14: made of sponge, rubber, or plastic materials
- A61F 5/0111: {for the feet or ankles}
- B33Y 10/00: Processes of additive manufacturing
- A43B: CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
- 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)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING

## Abstract

Orthotics and methods for forming orthotics are described. The orthotics can be designed with a patient-specific design and can include variation in hardness across the orthotic so as to satisfy clinical need. An orthotic can be a custom-designed orthotic formed according to an additive manufacturing process such as a 3-D printing methodology. Through utilization of on-site formation methods such as 3-D printing, an orthotic can be designed, formed and fit at the point of care in a much shorter time period than traditional orthotics. The orthotics can include a layer that includes a plurality of cells across the layer. The layer can exhibit variable hardness across the layer through variation in cell void volume and optionally material of formation across the layer.

## Claims

### Claim 1

An orthotic layer that exhibits a variable hardness across the orthotic layer, the orthotic layer comprising an upper surface and a lower surface and a plurality of cells arranged in a predetermined pattern across the orthotic layer, wherein every cell of the plurality of cells extends between the upper surface and the lower surface and every cell of the plurality of cells is open at either the upper surface or the lower surface of the orthotic layer, the plurality of cells including a first portion of cells in a first region of the orthotic layer, each cell of the first portion of cells having a first void volume, the plurality of cells including a second portion of cells in a second region of the orthotic layer, each cell of the second portion of cells having a second void volume, the first region having a first hardness and the second region having a second, different hardness as determined according to ASTM D 2240-05.

### Claim 2 (depends on 1)

The orthotic layer of claim 1, wherein the orthotic layer is a layer of a foot orthotic.

### Claim 3 (depends on 2)

The orthotic layer of claim 2, wherein the orthotic layer is a cushion layer.

### Claim 4 (depends on 1)

The orthotic layer of claim 1, wherein every cell of the plurality of cells has an identical cross sectional shape to every other cell of the plurality of cells.

### Claim 5 (depends on 1)

The orthotic layer of claim 1, wherein the plurality of cells includes cells of different cross sectional shapes and/or sizes.

### Claim 6 (depends on 1)

The orthotic layer of claim 1, wherein every cell of the plurality of cells has a perimeter of from about 1 mm to about 10 mm.

### Claim 7 (depends on 1)

The orthotic layer of claim 1, wherein every cell of the plurality of cells includes a surrounding wall, wherein a taper of the surrounding wall of each cell of the first portion of cells is different from a taper of the surrounding wall of each cell of the second portion of cells.

### Claim 8 (depends on 1)

The orthotic layer of claim 1, wherein the composition of formation of the first portion of cells differs from the composition of formation of the second portion of cells.

### Claim 9 (depends on 1)

The orthotic layer of claim 1, wherein the plurality of cells extend across the entire orthotic layer.

### Claim 10 (depends on 1)

The orthotic layer of claim 1, wherein the orthotic layer is a layer of a knee orthotic, an ankle orthotic, a hip orthotic, a spinal orthotic, a wrist orthotic, an elbow orthotic, a shoulder orthotic, a hand/palm/grip cushion system, a head/helmet cushion system, an elbow cushion system, or a hip/buttocks cushion systems.

### Claim 11

An orthotic comprising:
a base layer;
a cushion layer adjacent to the base layer, the cushion layer comprising an upper surface and a lower surface and plurality of cells arranged in a predetermined pattern across the cushion layer, the lower surface of the cushion layer being adjacent to an upper surface of the base layer, wherein every cell of the plurality of cells extends between the upper surface and the lower surface of the cushion layer and every cell of the plurality of cells is open at either the lower surface of the cushion layer or the upper surface of the cushion layer, the plurality of cells including a first portion of cells in a first region of the cushion layer, each cell of the first portion of cells having a first void volume, the plurality of cells including a second portion of cells in a second region of the cushion layer, each cell of the second portion of cells having a second void volume, the first region having a first hardness and the second region having a second, different hardness as determined according to ASTM D 2240-05; and optionally
a top layer adjacent to the cushion layer, the upper surface of the cushion layer being adjacent to a lower surface of the top layer, when present: wherein
the base layer, the cushion layer, and the top layer when present are not adhered to one another.

### Claim 12 (depends on 11)

The orthotic of claim 11, wherein the orthotic is a foot orthotic.

### Claim 13 (depends on 11)

The orthotic of claim 11, wherein every cell of the plurality of cells has a perimeter of from about 1 mm to about 10 mm.

### Claim 14 (depends on 11)

The orthotic of claim 11, wherein every cell of the plurality of cells includes a surrounding wall, wherein a taper of the surrounding wall of each cell of the first portion of cells is different from a taper of the surrounding wall of each cell of the second portion of cells.

### Claim 15 (depends on 11)

The orthotic of claim 11, wherein the composition of formation of the first portion of cells differs from the composition of formation of the second portion of cells.

### Claim 16 (depends on 11)

The orthotic of claim 11, wherein the base layer exhibits a variable hardness across the base layer.

### Claim 17 (depends on 11)

The orthotic of claim 11, wherein the plurality of cells extend across the entire cushion layer.

### Claim 18 (depends on 11)

The orthotic of claim 11, wherein the orthotic is a knee orthotic, an ankle orthotic, a hip orthotic, a spinal orthotic, a wrist orthotic, an elbow orthotic, a shoulder orthotic, a hand/palm/grip cushion system, a head/helmet cushion system, an elbow cushion system, or a hip/buttocks cushion systems.