System and method for rapidly customizing design, manufacture and/or selection of biomedical devices

• US 6,772,026 B2
• Filed: 10/05/2001
• Issued: 08/03/2004
• Est. Priority Date: 04/05/2000
• Status: Expired due to Term

• Current Assignee: Theken Spine LLC (Orthofix Medical Inc.)
• Original Assignee: Therics Inc.
• Inventors: Gaylo, Christopher M., Materna, Peter A., Bradbury, Thomas J., Chesmel, Kathleen D., Youssef, Adolphe, Fairweather, James A.
• Primary Examiner(s): Picard, Leo
• Assistant Examiner(s): Masinick, Michael D.
• Application Number:
  US09/972,832
• Publication Number:
  US 20020059049A1
• Time in Patent Office: 1,033 Days
• Field of Search: 700/98, 700/97, 700/119, 700/127, 700/163, 700/182
• US Class Current: 700/98
• CPC Class Codes: A61C 13/0004 Computer-assisted sizing or machining of dental prostheses
• CPC Class Codes: A61C 8/0006 Periodontal tissue or bone regeneration support means for endoprosthetic bone substitute or bone graft implants A61F2/2846
• CPC Class Codes: A61F 2/2803 for mandibular reconstruction temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071
• CPC Class Codes: A61F 2/30942 for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/2878 for orbital repair
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30948 using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/30953 using a remote computer network, e.g. Internet
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: B29C 64/135 the energy source being concentrated, e.g. scanning lasers or focused light sources
• CPC Class Codes: B29C 64/182 : in parallel batches
• CPC Class Codes: B33Y 50/00 : Data acquisition or data processing for additive manufacturing
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: B65G 2207/14 : Combination of conveyors
• CPC Class Codes: G05B 19/4099 : Surface or curve machining, making 3D objects, e.g. desktop manufacturing
• CPC Class Codes: G05B 2219/35008 : Www cad, world wide design and manufacturing
• CPC Class Codes: G05B 2219/35053 : IGES initial graphics exchange specification
• CPC Class Codes: G05B 2219/35054 : STEP or PDES, standard for exchange of product data, form or surface data
• CPC Class Codes: G05B 2219/35219 : From cad data derive cutting, stacking, sorting program
• CPC Class Codes: G05B 2219/35223 : Tolerance, consider tolerance in design, design for assembly
• CPC Class Codes: G05B 2219/45166 : Tomography
• CPC Class Codes: G05B 2219/45168 : Bone prosthesis
• CPC Class Codes: G05B 2219/49023 : 3-D printing, layer of powder, add drops of binder in layer, new powder
• CPC Class Codes: G06Q 10/06 : Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G06Q 30/0601 : Electronic shopping [e-shopping]
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders

Abstract

The rapid design and manufacture of biomedical devices such as implants, oral dosage pills and implantable pharmaceuticals employs electronic data and modeling transmissions via a computer network. Patient information and patient-specific radiological data is captured and transmitted via a computer network to a design and/or manufacturing site. A multi-dimensional digital model is created based on the radiological data and patient information. Communications interchanges between a clinical/diagnostic site and a design/manufacturing site permit modification of the digital model until approved. The approved digital model is converted into machine instructions to construct the biomedical device. Alternatively, the digital model is employed in a best fit selection of a biomedical device from a pre-existing set of biomedical devices or machine-instructions. Transmittal of data over computer networks is further directed to the use of a Website to perform various client-interaction and follow-up tasks.

Claims

1. A method for customized design of anatomically correct implants for a patient, comprising:

receiving radiological data representing a physical structure of an anatomical body part that is to be replaced, repaired or augmented;

creating a multi-dimensional digital model of at least a portion of the anatomical body part based on the received radiological data; and

modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model wherein modifying the multi-dimensional digital model includes adjusting a material density gradation through at least a portion of the multi-dimensional digital model based on a representative material density gradation of similar anatomical body parts, and wherein the first successive multi-dimensional model represents at least one physical characteristic of the anatomical body part not represented in the radiological data.

2. A method employing a computer system for customized design of biomedical devices, comprising:

receiving radiological data representing a physical structure of an anatomical body part;

producing a multi-dimensional digital model of at least a portion of the anatomical body part based on the received radiological data;

securely transmitting the multi-dimensional digital model over a communications channel;

receiving at least one request to modify at least a portion of the multi-dimensional digital model of the anatomical body part;

modifying the multi-dimensional digital model of the anatomical body part in response to the received request;

receiving an approval of the multi-dimensional digital model;

producing a biomedical device based on the approved multi-dimensional digital model, the biomedical device having at least some physical characteristics corresponding to the multi-dimensional digital model;

digitizing the biomedical device; and

comparing the digitized biomedical device with the multi-dimensional digital model to verify fit.

3. A method employing a computer system for customized design of biomedical devices, comprising:

receiving radiological data representing a physical structure of an anatomical body part;

producing a multi-dimensional digital model of at least a portion of the anatomical body part based on the received radiological data;

securely transmitting the multi-dimensional digital model over a communications channel;

receiving at least one request to modify at least a portion of the multi-dimensional digital model of the anatomical body part;

modifying the multi-dimensional digital model of the anatomical body part in response to the received request wherein modifying the multi-dimensional digital model includes;

determining a set of engineering constraints on the requested modification; and

applying a set of changes within the determined engineering constraints to the multi-dimensional digital model; and

receiving an approval of the multi-dimensional digital model.

4. A method employing a computer system for customized design of biomedical devices, comprising:

receiving radiological data representing a physical structure of an anatomical body part;

producing a multi-dimensional digital model of at least a portion of the anatomical body part based on the received radiological data;

securely transmitting the multi-dimensional digital model over a communications channel;

receiving at least one request to modify at least a portion of the multi-dimensional digital model of the anatomical body part;

modifying the multi-dimensional digital model of the anatomical body part in response to the received request;

receiving an approval of the multi-dimensional digital model;

selecting one of a number of already-manufactured biomedical devices on a best fit basis;

digitizing the selected biomedical device; and

comparing the digitized biomedical device with the multi-dimensional digital model to verify fit.

5. A server side computing system for biomedical device delivery, comprising:

means for receiving radiological data over a secure communications channel;

means for creating a multi-dimensional digital model based on the received radiological data;

means for modifying the multi-dimensional digital model to incorporate structure not available in the radiological data, comprising;

automated means for selecting an appropriate modification based on received patient related information; and

automated means for applying the selected appropriate modification to the multi-dimensional digital model; and

means for providing biomedical devices based on the multi-dimensional digital model.