# US 10,945,794 B2 · Computer-aided design and preparation of bone graft

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- Number: US 10,945,794 B2
- Document ID: US10945794B2
- Status: Granted
- Kind: B2
- Application number: 17/011,892
- Filed: 2020-09-03
- Published: 2020-12-24
- Granted: 2021-03-16
- Earliest claimed: 2019-04-23
- Applicants: Kristian Tjon
- Inventors: Kristian Tjon
- Web page: https://patentgrep.com/patent/US10945794B2

## CPC

- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61F 2/28: Bones
- A61F 2/2803: {for mandibular reconstruction (temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071)}
- A61F 2/3094: {Designing or manufacturing processes}
- 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 2/4644: {Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material (bone material A61F2/28; disintegrating or milling devices B02C)}
- A61K 35/32: Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61C 8/0012: {characterised by the material or composition, e.g. ceramics, surface layer, metal alloy (use of specific materials A61K6/00)}
- A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material}
- A61F 2002/30578: {having apertures, e.g. for receiving fixation screws}
- A61F 2002/30784: {Plurality of holes}
- A61F 2002/30948: {using computerized tomography, i.e. CT scans}
- A61F 2002/30952: {using CAD-CAM techniques or NC-techniques}
- A61F 2240/002: Designing or making customized prostheses
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F 2310/00359: Bone or bony tissue
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- 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)
- 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)
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)
- 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

Described herein is a method of preparing a bone graft product, comprising computer-guided precision cutting an unshaped piece of bone from a human cadaver or a bovine animal to provide a shaped piece of bone having a predetermined shape that is determined by a human being using computer-aided design. Bone graft products prepared using this method and methods of grafting these products are also disclosed.

## Claims

### Claim 1

A bone graft product suitable for use in a human being in need thereof comprising:
a shaped piece of bone; and
a sterile packaging containing the shaped piece of bone,
wherein the shaped piece of bone is prepared by using computer-guided precision cutting an unshaped piece of bone from a human cadaver or a bovine animal, and the shaped piece of bone having a predetermined shape that is determined using computer-aided design,
wherein the predetermined shape is determined based on the difference between the three dimensional shape of the bone at an intended graft site of the human being and the desired shape of the bone at the intended graft site of the human being after the graft is completed,
wherein the shaped piece of bone has a desired shape and size that fits in the intended graft site precisely when inserted into the bone defect,
wherein no part of the bone at the intended graft site is removed from the human being, and
wherein the unshaped piece of bone comprises any piece of bone from a human cadaver or a bovine animal that was not prepared by combining smaller pieces of bones.

### Claim 2 (depends on 1)

The bone graft product of claim 1, wherein the three dimensional shape of the bone at the intended graft site is obtained by computed tomography scan.

### Claim 3 (depends on 1)

The bone graft product of claim 1, wherein the predetermined shape of the bone graft is designed using a 3D-modeling software.

### Claim 4 (depends on 1)

The bone graft product of claim 1, wherein the shaped piece of bone is manufactured by a process comprising the use of a computer-guided milling machine unit.

### Claim 5 (depends on 1)

The bone graft product of claim 1, wherein the shaped piece of bone has a volume of at least 0.1 cc.

### Claim 6 (depends on 1)

The bone graft product of claim 1, wherein the shaped piece of bone further comprises pre-formed holes that are suitable for fixing the shaped piece of bone into the intended graft site with surgical screws.

### Claim 7 (depends on 1)

The bone graft product of claim 1, wherein the thickness of the shaped piece of bone is no less than 3 mm.

### Claim 8 (depends on 1)

The bone graft product of claim 1, wherein the shaped piece of bone is customized to the human being.

### Claim 9 (depends on 1)

The bone graft product of claim 1, wherein the shaped piece of bone is suitable to be bolted to a bone at the intended graft site of the human being.

### Claim 10 (depends on 1)

The bone graft product of claim 1, further comprising a graft enhancing agent.

### Claim 11 (depends on 10)

The bone graft product of claim 10, wherein the graft enhancing agent is applied to the shaped piece of bone, the bone at the intended graft site, or tissue surrounding the bone at the intended graft site, or a combination thereof, when grafting the shaped piece of bone.

### Claim 12 (depends on 1)

The bone graft product of claim 1, wherein the shaped piece of bone has a shape that is suitable for cosmetic plastic surgery.

### Claim 13 (depends on 1)

The bone graft product of claim 1, wherein the shaped piece of bone has a shape that is suitable for post-cancer reconstructive surgery.

### Claim 14 (depends on 1)

The bone graft product of claim 1, wherein the shaped piece of bone has a shape that is suitable for adjunct bone augmentation for orthopedic surgery.

### Claim 15 (depends on 1)

The bone graft product of claim 1, wherein the shaped piece of bone has a shape that is suitable for dental implant.

### Claim 16 (depends on 1)

The bone graft product of claim 1, wherein the shaped piece of bone is ready for direct placement at the intended bone graft site.