# US 11,896,488 B2 · Reinforced bone scaffold

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- Number: US 11,896,488 B2
- Document ID: US11896488B2
- Status: Granted
- Kind: B2
- Application number: 17/240,562
- Filed: 2021-04-26
- Published: 2021-08-19
- Granted: 2024-02-13
- Earliest claimed: 2016-05-02
- Assignees: Marquette University
- Applicants: Marquette University
- Inventors: Lobat Tayebi; Morteza Rasoulianboroujeni
- Web page: https://patentgrep.com/patent/US11896488B2

## CPC

- A61F 2/28: Bones
- A61K 38/1875: {Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor}
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/20: Polysaccharides
- A61L 27/222: {Gelatin}
- A61L 27/225: {Fibrin; Fibrinogen}
- A61L 27/24: Collagen
- A61L 27/425: {of phosphorus containing material, e.g. apatite}
- A61L 27/46: with phosphorus-containing inorganic fillers
- A61L 27/48: with macromolecular fillers
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61L 27/58: Materials at least partially resorbable by the body
- A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques}
- A61F 2002/30011: {differing in porosity}
- A61F 2002/30032: {differing in absorbability or resorbability, i.e. in absorption or resorption time}
- A61F 2002/30075: {swellable, e.g. when wetted}
- A61F 2002/3092: {having an open-celled or open-pored structure}
- A61F 2002/30962: {using stereolithography}
- A61F 2310/00365: Proteins; Polypeptides; Degradation products thereof
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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

Scaffolds for use in bone tissue engineering include a skeleton and a host component. Methods of preparation of scaffolds include identification of biodegradation properties for the skeleton and the host component. The skeleton is constructed to form a three-dimensional shape. The skeleton is constructed of a first material and has a first rate of biodegradation. The host component fills the three-dimensional shape formed by the skeleton. The host component is constructed of a second material and has a second rate of biodegradation. The first rate of biodegradation is slower than the second rate of biodegradation.

## Claims

### Claim 1

A method of preparing a scaffold for use in bone tissue engineering, the method comprising:
obtaining a 3D model of a treatment area of a patient;
determining a degradability of the scaffold based upon the patient and treatment area;
selecting a first porosity of a skeleton and a first rate of biodegradation of the skeleton;
selecting a second porosity of a host component and a second rate of biodegradation of the host component to achieve the degradability;
digitally designing a skeleton to fit the treatment area;
manufacturing the skeleton with a material having the first porosity and first rate of biodegradation to form a three-dimensional shape defining a space; and
filling the space defined by the skeleton with the host component having the second porosity and the second rate of biodegradation, wherein the first porosity is smaller than the second porosity and the first rate of biodegradation is slower than the second rate of biodegradation.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
selecting at least one skeleton characteristic that contributes to the first rate of biodegradation, the at least one skeleton characteristic being selected from the list consisting of at least one of a base material, a material processing technique, and a pore size; and
selecting at least one host characteristic that contributes to the second rate of biodegradation, the at least one host characteristic being selected from the list consisting of: a base material, a material processing technique, and a pore size.

### Claim 3 (depends on 2)

The method of claim 2, wherein manufacturing the skeleton comprises 3D printing the skeleton.

### Claim 4 (depends on 3)

The method of claim 3, further comprising 3D printing the host component integrated with the skeleton simultaneous to 3D printing the skeleton.

### Claim 5 (depends on 1)

The method of claim 1 wherein the host component is a foam, and further comprising freeze-drying the skeleton filled with the host component to create the scaffold.

### Claim 6 (depends on 1)

The method of claim 1, further comprising:
selecting at least one material of the host component;
creating solution of the at least one material of the host component;
agitating the solution to produce a host component foam;
molding the host component foam into the skeleton;
freezing the skeleton filled with the host component foam; and
freeze-drying the skeleton and the host component.

### Claim 7 (depends on 6)

The method of claim 6 wherein the at least one material for the host component comprises a polymer or a protein.

### Claim 8 (depends on 7)

The method of claim 7, wherein agitating the solution comprises agitating the solution at a speed between 100 revolutions per minute (RPM) and 40000 RPM for a length of time between 1 minute and 60 minutes.

### Claim 9 (depends on 5)

The method of claim 5, further comprising:
washing the freeze-dried skeleton and the host component with a cross-linker to promote cross-linking between the host component and the skeleton; and
freeze-drying the washed host component and the skeleton to cross link the host component and the skeleton.

### Claim 10 (depends on 9)

The method of claim 9 wherein the cross-linker comprises at least one of glutaraldehyde, EDC/NHS, and paraformaldehyde.

### Claim 11 (depends on 1)

The method of claim 1, wherein the scaffold is a unitary structure comprising the skeleton and the host component.

### Claim 12 (depends on 11)

The method of claim 11, further comprising forming the unitary structure by macroscale, microscale, or nanoscale physical interlocking between the skeleton and the host component.

### Claim 13 (depends on 1)

The method of claim 1 wherein the host component surrounds the skeleton.

### Claim 14 (depends on 1)

The method of claim 1, wherein a first dimensional plane through the scaffold comprises both a first portion of the skeleton and a first portion of the host component.

### Claim 15 (depends on 14)

The method of claim 14 wherein digitally designing the skeleton further comprises orienting the first dimensional plane in a direction of the expected forces to be applied to the first portion of the skeleton in vivo.

### Claim 16 (depends on 14)

The method of claim 14, wherein a second dimensional plane, orthogonal to the first dimensional plane, comprises both a second portion of the skeleton and a second portion of the host component.
