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US8457930B2 Active / In Force US ⏱️ 3.4 years remaining

Personalized fit and functional designed medical prostheses and surgical instruments and methods for making

Assignee: Individual
•
Filing: 2010-04-15
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Granted: 2013-06-04
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Expires: 2030-04-15
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Abstract

Abstract The present invention provides methods, devices, systems, and instruments related to medical implants and surgical instruments produced to precisely fit individual subjects. In particular, the present invention utilizes a combination of medical imaging, quantitative image analysis, CAD, CAM, and additive manufacturing processes to personalized biocompatible devices.

Inventors

  • 👤 James Schroeder

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-08 20:48
CPC Classifications
G; G06; G06F; G06F30/00; G06F30/20; G06F30/23; A; A61; A61F; A61F2/00; A61F2/02; A61F2/30; B; B33; B33Y; B33Y50/00; B33Y70/00; B33Y80/00; G16; G16H; G16H10/00; G16H10/60; G16H50/00; G16H50/50; A61F2/28; A61F2/2875; A61F2/32; A61F2/3094; A61F2/30942; A61F2002/30948; A61F2002/30952; G06F2111/00; G06F2111/20

Claims Analysis

Total Claims: 20
Claim 1
Independent Claim 86 words
A method of personalizing a biocompatible device, comprising the steps of: (a) obtaining a profile of the subject, wherein said profile comprises imaging of said subject; transferring the subject profile to a design/manufacturing team and generating a subject profile and case number; (b) producing a virtual 3D design model, wherein said virtual 3D design model is configured to the parameters from said imaging of said subject; and (c) producing a biocompatible device, wherein said biocompatible device is configured to the subject profile and 3D design model.
Claim 2
Independent Claim 86 words
A method of personalizing a biocompatible device, comprising the steps of: (a) obtaining a profile of the subject, wherein said profile comprises imaging of said subject; transferring the subject profile to a design/manufacturing team and generating a subject profile and case number; (b) producing a virtual 3D design model, wherein said virtual 3D design model is configured to the parameters from said imaging of said subject; and (c) producing a biocompatible device, wherein said biocompatible device is configured to the subject profile and 3D design model.
Claim 3
Dependent Claim 30 words
The method of personalizing a biocompatible device of claim 1 , wherein said imaging comprises CT (computed tomography), MRI (magnetic resonance imaging), PET (positron emission tomography), digital X-ray, and ultrasound.
Claim 4
Dependent Claim 34 words
The method of personalizing a biocompatible device of claim 1 , wherein producing a virtual 3D design model comprises calibrating, analyzing and producing a 3D CAD (computer-aided design) solid model from said imaging data.
Claim 5
Dependent Claim 53 words
The method of personalizing a biocompatible device of claim 1 , wherein producing a virtual 3D design model comprises methods selected from CAD (computer-aided design), CAM (computer aided manufacturing), FEA (finite element analysis) of biological tissue of the subject, FEA of materials, joint articulation simulation, solid modeling or 3D visualization instruments and methods.
Claim 6
Dependent Claim 119 words
The method of personalizing a biocompatible device of claim 1 , wherein producing a virtual 3D design model comprises the steps of: i) creating a 3D surface model of the bone of the subject, wherein said 3D surface model is configured to the parameters from said imaging of said subject; ii) creating a preliminary exact fit model of a virtual model or a physical model, wherein said preliminary exact fit model is configured to the parameters from said imaging of said subject; and iii) designing a personalized biocompatible device, wherein said personalized biocompatible device is configured to accurately fit with said 3D surface model of the bone of the subject, subject profile variables, and quality of the preserved bone.
Claim 7
Dependent Claim 30 words
The method of personalizing a biocompatible device of claim 1 , further comprising a step following step (b) but prior to step (c) of evaluating said virtual 3D design model.
Claim 8
Dependent Claim 69 words
The method of personalizing a biocompatible device of claim 6 , wherein evaluating said virtual 3D design model comprises: a) performing a device simulation to analyze said virtual 3D design model; b) performing FEA (finite element analysis), wherein said FEA assesses function of said personalized biocompatible device based on a subject profile; c) using a hybrid model to validate said virtual 3D design model; and/or d) performing surgical simulation.
Claim 9
Dependent Claim 44 words
The method of personalizing a biocompatible device of claim 1 , further comprising the step following step (b) but prior to step (c) of programming a CAS (computer assisted surgery) system and verifying the CAS program using a virtual 3D model of said subject.
Claim 10
Dependent Claim 52 words
The method of personalizing a biocompatible device of claim 1 , further comprising the step following step (b) but prior to step (c) of collaborating between the surgical team and the design/manufacturing team to review and optionally modify said virtual 3D design and to finalize the design of said personalized biocompatible device.
Claim 11
Dependent Claim 30 words
The method of personalizing a biocompatible device of claim 9 , wherein modifications are evaluated by finite element analysis, surgical simulation, device simulation, hybrid model, and/or CAS (computer assisted surgery).
Claim 12
Dependent Claim 38 words
The method of personalizing a biocompatible device of claim 1 , wherein said manufacturing said biocompatible device comprises manufacturing a 3D physical model of said biocompatible device and a 3D physical model of the bone of said subject.
Claim 13
Dependent Claim 35 words
The method of personalizing a biocompatible device of claim 1 , wherein said manufacturing the biocompatible device comprises additive manufacturing technology, multi-axis grinding and polishing, and/or verifying finished quality and dimensions of said biocompatible device.
Claim 14
Dependent Claim 23 words
The method of personalizing a biocompatible device of claim 1 , wherein said manufacturing the biocompatible device comprises sterilization of said biocompatible device.
Claim 15
Dependent Claim 27 words
The method of personalizing a biocompatible device of claim 1 , further comprising the step following step (c) of implanting said personalized biocompatible device into said subject.
Claim 16
Dependent Claim 54 words
The method of personalizing a biocompatible device of claim 1 , further comprising the step following step (c) of verifying the fit of said biocompatible device, wherein said verifying comprises CT (computed tomography), MRI (magnetic resonance imaging), PET (positron emission tomography), digital X-ray, ultrasound, and other scanning of said subject and said biocompatible device.
Claim 17
Dependent Claim 25 words
The method of personalizing a biocompatible device of claim 1 , further comprising the step following step (c) comparing actual implantation results to device simulation.
Claim 18
Dependent Claim 42 words
The method of personalizing a biocompatible device of claim 1 , wherein said device is selected from a group consisting of a skeletal orthopedic prosthesis or implant, a dental prosthesis or implant or a soft tissue or hard tissue prosthesis or implant.
Claim 19
Dependent Claim 46 words
The method of personalizing a biocompatible device of claim 1 , wherein said biocompatible device is manufactured from materials selected from a group consisting of CoCrMo alloy, Titanium alloy, Ti6, cpTi, medical grade stainless steel, Tantalum, Tantalum alloy, Nitinol, ceramics, oxides, minerals, glasses and combinations thereof.
Claim 20
Dependent Claim 33 words
The method of personalizing a biocompatible device of claim 1 , wherein said biocompatible device has internal structure or surface selected from a group comprising honeycombs, struts, ribs, hollow, solid or combinations thereof.

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