# US 11,638,646 B1 · Bioceramic implants matched to patient specific and bone specific geometry

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- Number: US 11,638,646 B1
- Document ID: US11638646B1
- Status: Granted
- Kind: B1
- Application number: 16/995,666
- Filed: 2020-08-17
- Granted: 2023-05-02
- Earliest claimed: 2019-08-16
- Assignees: 3D-Biomaterials, LLC
- Applicants: 3D Biomaterials
- Inventors: David Christopher Delaney; Duran N Yetkinler
- Web page: https://patentgrep.com/patent/US11638646B1

## CPC

- 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 2/28: Bones
- A61F 2/2875: {Skull or cranium (A61F2/2803 takes precedence; joints for temporo-mandibular [TM] joints [TMJ] A61F2/3099)}
- B28B 1/001: {Rapid manufacturing of 3D objects by additive depositing, agglomerating or laminating of material (selective deposition modelling of metallic powder B22F10/00; rapid manufacturing of 3D objects in general and in particular of plastics B29C64/00)}
- B33Y 10/00: Processes of additive manufacturing
- B33Y 50/00: Data acquisition or data processing for additive manufacturing
- B33Y 70/00: Materials specially adapted for additive manufacturing
- B33Y 80/00: Products made by additive manufacturing
- A61F 2002/30948: {using computerized tomography, i.e. CT scans}
- A61F 2002/30957: {using a positive or a negative model, e.g. moulds}
- A61F 2002/30968: {Sintering}
- A61F 2002/30985: {using three dimensional printing [3DP]}
- A61F 2310/00179: Ceramics or ceramic-like structures
- A61F 2310/00221: containing calcia or calcium oxide
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- 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)
- B28B: SHAPING CLAY OR OTHER CERAMIC COMPOSITIONS; SHAPING SLAG; SHAPING MIXTURES CONTAINING CEMENTITIOUS MATERIAL, e.g. PLASTER (foundry moulding B22C; working stone or stone-like material B28D; shaping of substances in a plastic state, in general B29C; making layered products not composed wholly of these substances B32B)
- 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

The production of bioceramic powders and bioceramic implants are described and an additive manufactured implant used for tissue reconstruction and a method for manufacturing the implant are disclosed. The implant may be fabricated at least in part from suitable bioceramic powders produced using tailored mineral compositions tailored to the unique material properties of the tissue being replaced. The implants may be tailored to a three-dimensional shape and mechanical properties of the tissue defect designed to be replaced by surgical implantation of the device. Native tissue repair and regeneration at the site of implantation are also provided.

## Claims

### Claim 1

An additive manufacturing method for producing a bioceramic implant, the method comprising:
optimization of the implant's mechanical and physical properties to the mechanical and physical properties of the bone tissue being surgically repaired by examination of a patient's bone properties following X-ray/CT imaging, mechanical property prediction with computer modeling and manipulation of ceramic powder precursors used in the additive manufacturing process to produce the implant such that the implant is composed of primarily calcium phosphate, tailoring the ceramic precursor properties and thus ensuring implant material and mechanical properties closely match properties of bone tissue being replaced by said implant, where the resulting implant is used in a bone defect.

### Claim 2 (depends on 1)

The method of claim 1 wherein the implant is shaped to match, in 3D space, the geometrical shape of the bone tissue prior to the injury suffered by the patient.

### Claim 3 (depends on 1)

The method of claim 1 wherein the implant is shaped to match with sub-millimeter accuracy, the bone tissue architecture of preexisting bone prior to the injury suffered by the patient.

### Claim 4 (depends on 1)

The method of claim 1 wherein the implant is shaped to match, in 3D space, the geometrical shape of a skull prior to the injury suffered by the patient.

### Claim 5 (depends on 1)

The method of claim 1 wherein the calcium phosphate is a phase pure calcium phosphate.

### Claim 6 (depends on 1)

The method of claim 1 wherein the calcium phosphate is a phase pure hydroxyapatite.

### Claim 7 (depends on 1)

The method of claim 1 wherein the calcium phosphate is a transition metal substituted hydroxyapatite.

### Claim 8 (depends on 1)

The method of claim 1 wherein the calcium phosphate is a metalloid substituted hydroxyapatite.

### Claim 9 (depends on 1)

The method of claim 1 wherein the calcium phosphate is a phase pure whitlockite.

### Claim 10 (depends on 1)

The method of claim 1 wherein the calcium phosphate is alpha-tricalcium phosphate.

### Claim 11 (depends on 1)

The method of claim 1 wherein the calcium phosphate is beta tricalcium phosphate.

### Claim 12 (depends on 1)

The method of claim 1 wherein the additive manufacturing process comprises ceramic 3D printing.

### Claim 13 (depends on 1)

The method of claim 1 wherein the additive manufacturing process comprises ceramic injection molding.

### Claim 14 (depends on 1)

The method of claim 1 wherein the implant is manufactured with specifications generated from finite element modeling of the mechanical properties of the site of bone implantation.

### Claim 15 (depends on 1)

The method of claim 1 wherein the implant is manufactured with specifications generated from quantitative micro CT imaging of the microstructure of the site of bone implantation.

### Claim 16 (depends on 1)

The method of claim 1 wherein the implant is manufactured with specifications generated from parametric modeling of the microstructure of the site of bone implantation.