System and method for rapidly customizing a design and remotely manufacturing biomedical devices using a computer system

• US 20020007294A1
• Filed: 04/05/2001
• Published: 01/17/2002
• Est. Priority Date: 04/05/2000
• Status: Abandoned Application

• Current Assignee: Therics Inc.
• Original Assignee: Therics Inc.
• Inventors: Gaylo, Christopher M., Fairweather, James A., Materna, Peter A., Bradbury, Thomas J., Chesmel, Kathleen D.
• Application Number:
  US09/828,504
• Publication Number:
  US 20020007294A1
• Time in Patent Office: Days
• US Class Current: 705/7
• 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: 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 10/00 : Administration; Management
• CPC Class Codes: G06Q 10/06 : Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 30/20 : for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders

Abstract

A method of rapid design and manufacture of biomedical devices using electronic data and modeling transmissions, wherein such transmissions are transferred via a computer network. The method includes capturing patient-specific diagnostic imaged data, converting the data to a digital computer file, transmitting the converted data via the computer network to a remote manufacturing site, converting the computer file into a multi-dimensional model and then into machine instructions, and constructing the biomedical implant. The present invention is further directed to the preparation of rapid-prototyped pharmaceutical forms, including oral dosage pills and implantable pharmaceuticals, with transmittal of such data over computer networks being used to significantly increase the cost effectiveness and responsiveness, and is further directed to the use of a website to perform various client-interaction and follow-up tasks.

Claims

1. A method in a computer system for customized design and manufacture of an anatomically correct implant customized for a patient, comprising:

producing a radiological image of an anatomical body part or bone that is to be replaced, repaired or augmented;

converting the radiological image into a format transmittable over a computer system;

creating a computer based multi-dimensional model based on the converted patient specific radiological image;

modifying the multi-dimensional model using the computer system; and

manufacturing an implant according to the modified model using three-dimensional printing techniques.

2. The method of claim 1, further comprising compositional design within the multi-dimensional model that are translated into the manufactured implant.

3. The method of claim 1, further comprising transmitting the multi-dimensional model to a client for approval prior to manufacturing the biomedical implant.

4. The method of claim 1, further comprising growth factors, comb polymers, or other substances having biological activity.

5. The method of claim 1, further comprising markers for future radiological viewing.

6. A method for manufacturing and selling individually fitted customized biomedical devices for a given recipient via a computer network, comprising:

capturing data in a computerized form;

converting the data to a multi-dimensional model;

modifying the multi-dimensional model to include an internal architecture,

converting the modified multi-dimensional model into machine instructions;

manufacturing a customized biomedical device from the machine instructions wherein the biomedical device is anatomically correct to the individual patient; and

shipping the biomedical device to the recipient for implantation.

7. The method of claim 6, further comprising transmitting the modified multi-dimensional model to the recipient for further modification prior to converting the model into machine instructions.

8. A method for manufacturing and selling customized medical devices via a computer network, comprising:

transmitting patient-specific data from a patient location to a secure web site via a computer network;

manufacturing the medical device based on the transmitted data;

delivery of the medical device; and

maintaining records of the patient-specific data.

9. The method of claim 8, further comprising generating follow-up notices based on the maintained records.

10. The method of claim 8 wherein the medical device is an oral dosage form containing one or more active pharmaceutical ingredients.

11. The method of claim 8 wherein the medical device is an implantable drug delivery device containing one or more active pharmaceutical ingredients.

12. The method of claim 8 wherein the medical device is manufactured by three dimensional printing.

13. The method of claim 8 wherein manufacturing the medical device further includes selecting the best fit implant from a group of already-manufactured implants.

14. An Internet-enabled method for designing and manufacturing biomedical devices comprising:

using an Internet-enabled system to transmit radiological images to a central server;

converting the radiological images into a digital format;

transmitting the digital format of the radiological images to the central server operably connected to a manufacturing station; and

manufacturing the biomedical device in accordance with the radiological image.

15. The method of claim 15, further comprising creating a multidimensional model from the digital format of the image and transmitting the model to a client for modification.

16. The method of claim 15 wherein manufacturing the biomedical device in accordance with the radiological image includes selecting a best fit from a plurality of already manufactured medical devices.