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

• US 20040243481A1
• Filed: 07/01/2004
• Published: 12/02/2004
• Est. Priority Date: 04/05/2000
• Status: Abandoned Application

• Current Assignee: Therics Inc.
• Original Assignee: Therics Inc.
• Inventors: Youssef, Adolphe, Gaylo, Christopher M., Fairweather, James A., Materna, Peter A., Bradbury, Thomas J., Chesmel, Kathleen D.
• Application Number:
  US10/882,449
• Publication Number:
  US 20040243481A1
• Time in Patent Office: Days
• US Class Current: 705/26
• 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 manufacturing and selling customized biomedical devices via a computer network, comprising:

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

manufacturing a biomedical device based on the transmitted data;

delivering the biomedical device; and

maintaining records of the patient-specific data.

2. The method of claim 1, further comprising:

generating follow-up notices based on the maintained records.

3. The method of claim 1 wherein the biomedical device is an oral dosage form containing at least one active pharmaceutical ingredient.

4. The method of claim 1 wherein the biomedical device is an implantable drug delivery device containing at least one active pharmaceutical ingredient.

5. The method of claim 1 wherein manufacturing a biomedical device based on the transmitted data includes:

creating a set of machine instructions based on the transmitted data; and

three-dimensionally printing according to the machine instructions to create the biomedical device.

6. The method of claim 1, further comprising:

creating a set of machine instructions based on the transmitted data; and

three-dimensionally printing according to the machine instructions to create at least two biomedical devices.

7. The method of claim 1 wherein the transmitted data includes time release information for at least one active pharmaceutical ingredient.

8. The method of claim 1, further comprising:

producing a first Webpage for display at a design location, the first Webpage providing access to a first set of data; and

producing a second Webpage for display at a at a diagnostic location, the second Webpage providing access to a second set of data, the second set of data omitting at least one piece of data contained in the first set of data.

9. A method for delivery of customized medical devices, comprising:

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

selecting a medical device from a stock of pre-made medical devices based on the transmitted data;

delivering the selected medical device; and

maintaining records of the patient-specific data.

10. The method of claim 9, further comprising

generating follow-up notices based on the maintained records.

11. The method of claim 9 wherein the selected medical device is an oral dosage form containing at least one active pharmaceutical ingredient.

12. The method of claim 9 wherein the selected medical device is an implantable drug delivery device containing at least one active pharmaceutical ingredient.

13. The method of claim 9 wherein the transmitted data includes time release information for at least one active pharmaceutical ingredient.

14. The method of claim 9, further comprising:

maintaining records of inventory.

15. The method of claim 14, further comprising:

automatically ordering replacement materials based on the records of inventory.

16. A computer-readable media for causing a computing system to automate manufacturing and selling individually fitted customized biomedical devices for a given recipient via a computer network, by:

receiving radiological data in a computerized form;

converting the radiological 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.

17. The computer-readable media of claim 16 for causing a computing system to automate manufacturing and selling individually fitted customized biomedical devices for a given recipient via a computer network, further by:

maintaining records of inventory.

18. The computer-readable media of claim 17 for causing a computing system to automate manufacturing and selling individually fitted customized biomedical devices for a given recipient via a computer network, further by:

automatically ordering replacement materials based on the records of inventory.

19. A computer-readable media for causing a computing system to automate delivery of customized medical devices, by:

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

selecting a medical device from a stock of pre-made medical devices based on the transmitted data;

delivering the selected medical device; and

maintaining records of the patient-specific data.

20. The computer-readable media of claim 19 for causing a computing system to automate delivery of customized medical devices, further by:

maintaining records of inventory.

21. The computer-readable media of claim 20 for causing a computing system to automate delivery of customized medical devices, further by:

automatically ordering replacement materials based on the records of inventory.