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

• US 20020059049A1
• Filed: 10/05/2001
• Published: 05/16/2002
• Est. Priority Date: 04/05/2000
• Status: Active Grant

• Current Assignee: Theken Spine LLC (Orthofix Medical Inc.)
• Original Assignee: Therics Inc.
• Inventors: Materna, Peter A, Gaylo, Christopher M., Fairweather, James A., Bradbury, Thomas J., Chesmel, Kathleen D., Youssef, Adolphe
• Granted Patent: US 6,772,026 B2
• Time in Patent Office: Days
• US Class Current: 703/11
• 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, the first successive multi-dimensional model representing at least one physical characteristic of the anatomical body part not represented in the radiological data.

2. The method of claim 1 wherein modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model includes selecting the at least one physical characteristic of the anatomical body part not represented in the radiological data based on at least one of demographic data and histographic data representing similar anatomical body parts.

3. The method of claim 1 wherein modifying the multi-dimensional digital model to create at least a first successive multi-dimensional 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.

4. The method of claim 1 wherein modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model includes incorporating at least one attachment structure into the multi-dimensional digital model.

5. The method of claim 1 wherein modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model includes incorporating into the multi-dimensional digital model markers for future radiological viewing.

6. The method of claim 1 wherein modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model includes incorporating into the multi-dimensional digital model a location of at least a portion of a comb polymer.

7. The method of claim 1 wherein modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model includes incorporating into the multi-dimensional digital model a location of at least one active pharmaceutical ingredient.

8. The method of claim 1 wherein modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model includes incorporating into the multi-dimensional digital model a location at least one of a source of a growth factor, a gene and a portion of DNA.

9. The method of claim 1 wherein modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model includes incorporating an internal structure into the multi-dimensional digital model.

10. The method of claim 1 wherein modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model includes incorporating at least one boundary into the multi-dimensional digital model.

11. The method of claim 1 wherein receiving radiologic al data representing a physical structure of an anatomical body part that is to be replaced, repaired or augmented includes receiving at least one of computer aided tomography data and magnetic resonance imaging data.

13. The method of claim 12, further comprising:

manufacturing an implant having at least some of the physical characteristics defined by at least one of the successive multi-dimensional digital models.

14. The method of claim 12, further comprising:

driving a three-dimensional printer according to the machine instructions to manufacture an implant having at least some physical characteristics defined by at least one of the successive multi-dimensional digital models.

15. The method of claim 12 wherein creating a set of machine instructions includes setting a variable corresponding to an amount of printing material to dispense.

16. The method of claim 12 wherein creating a set o f machine instructions based on at least one of the successive multi-dimensional digital models includes ray casting the multi-dimensional digital model.

18. The method of claim 17, further comprising:

receiving a multi-dimensional digital model of at least a portion of the anatomical body part based at least in part on the radiological data and that incorporates the at least one physical characteristic not represented in the radiological data.

19. The method of claim 17, further comprising:

receiving a first multi-dimensional digital model of at least a portion of the anatomical body part based at least in part on the radiological data and that incorporates the at least one physical characteristic not represented in the radiological data;

requesting modification of the first multi-dimensional digital model remotely;

receiving at least one successive multi-dimensional digital model incorporating at least some of the requested modification; and

approving at least one of the successive multi-dimensional digital models modified according to the requested modification.

20. The method of claim 17 wherein providing patient related information includes providing at least one of a patient gender, a patient age, a unique patient identifier, a dosage, and a patient physical dimension.

12. A method for customized design and manufacture 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 an initial multi-dimensional digital model of at least a portion of the anatomical body part based on the received radiological data;

modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model, the first successive multi-dimensional model representing at least one physical characteristic of the anatomical body part not represented in the radiological data; and

creating a set of machine instructions based on at least one of the successive multi-dimensional digital models.

17. A method for customized design and manufacture of anatomically correct implants for a patient, comprising:

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

providing the radiological data remotely from the capture;

providing patient related information remotely over a communications channel; and

receiving an implant having at least some physical characteristics corresponding the radiological data and at least one physical characteristic not represented in the radiological data and derived from the patient related information.

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

receiving radiological data in a computer-readable 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.

22. The method of claim 21, further comprising transmitting the modified multi-dimensional model to the recipient for further review prior to converting the model into machine instructions.

23. The method of claim 21, further comprising:

combining the machine instructions for at least two multi-dimensional models into a single job.

25. The method of claim 24, further comprising:

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.

26. The method of claim 24, further comprising:

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.

27. The method of claim 24 wherein modifying the multi-dimensional digital model of the anatomical body part in response to the received request 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.

28. The method of claim 24, further comprising:

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

29. The method of claim 24, further comprising:

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.

30. The method of claim 24 wherein securely transmitting the multi-dimensional digital model over a communications channel includes at least one of encrypting the multi-dimensional digital model, password protecting the multi-dimensional digital model and issuing a digital certificate for the multi-dimensional digital model.

24. 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; and

receiving an approval of the multi-dimensional digital model.

31. 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.

32. The method of claim 31, further comprising

generating follow-up notices based on the maintained records.

33. The method of claim 31 wherein the biomedical device is an oral dosage form containing at least one active pharmaceutical ingredient.

34. The method of claim 31 wherein the biomedical device is an implantable drug delivery device containing at least one active pharmaceutical ingredient.

35. The method of claim 31 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.

36. The method of claim 31, 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.

37. The method of claim 31 wherein the transmitted data includes time release information for at least one active pharmaceutical ingredient.

38. The method of claim 31, 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.

40. The method of claim 39, further comprising generating follow-up notices based on the maintained records.

41. The method of claim 39 wherein the selected medical device is an oral dosage form containing at least one active pharmaceutical ingredient.

42. The method of claim 39 wherein the selected medical device is an implantable drug delivery device containing at least one active pharmaceutical ingredient.

43. The method of claim 39 wherein the transmitted data includes time release information for at least one active pharmaceutical ingredient.

39. 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.

44. 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; and

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

45. The server side computing system of claim 44 wherein the means for providing biomedical devices based on the multi-dimensional digital model, comprises:

computing means for producing machine instructions based on the multi-dimensional digital model; and

peripheral means for manufacturing the biomedical devices according to the machine instructions.

46. The server side computing system of claim 44 wherein the means for providing biomedical devices based on the multi-dimensional digital model, comprises:

computing means for producing machine instructions based on the multi-dimensional digital model; and

a three dimensional printer coupled to the computing means to execute the machine instructions.

47. The server side computing system of claim 44 wherein the means for providing biomedical devices based on the multi-dimensional digital model, comprises:

peripheral means for selecting a biomedical device from a stock of biomedical devices on a best fit basis.

48. The server side computing system of claim 44 wherein the means for modifying the multi-dimensional digital model to incorporate structure not available in the radiological data, comprises:

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

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

49. The server side computing system of claim 44 wherein the means for modifying the multi-dimensional digital model to incorporate structure not available in the radiological data, comprises:

a user input device for allowing a user to select an appropriate modification based at least in part on a modification request; and

means for applying the selected appropriate modification to the multi-dimensional digital model.

50. A server side computing system for designing biomedical devices, comprising:

a communications subsystem couplable to a communications channel to securely receive radiological data;

a processor coupled to the communications subsystem to execute instructions; and

a computer-readable memory subsystem storing a first set of processor executable instructions to create a multi-dimensional digital model based on the received radiological data, and a second set of processor executable instructions to modify the multi-dimensional digital model to incorporate structure not available in the radiological data.

51. The server side computing system of claim 50 wherein the computer-readable memory subsystem further stores a third set of processor executable instructions to create a set of machine instructions based on the modified multi-dimensional digital model, and further comprising:

a three-dimensional printer responsive to the machine instructions.

52. The server side computing system of claim 50 wherein the computer-readable memory subsystem stores a third set of processor executable instructions to compare the modified multi-dimensional digital model to at least one of a set of predefined digital models representing respective ones of a set of stock biomedical devices.

53. The server side computing system of claim 50 wherein the communications subsystem is further couplable to the communications channel to securely receive one or more modification requests, and further comprising:

a user input device coupled to the processor to modify the multi-dimensional digital model in response to the received modification requests.

54. The server side computing system of claim 50 wherein the communications subsystem is further couplable to the communications channel to securely receive patient information including at least one of a patient gender, a patient age, a unique patient identifier, a dosage, and a patient physical dimension.

55. The server side computing system of claim 50 wherein second set of processor executable instructions includes a number of distinct user selectable transformations.

56. The server side computing system of claim 50 wherein second set of processor executable instructions includes a number of distinct transformations, the transformations mapped to patient information including at least one of a patient gender, a patient age, a unique patient identifier, a dosage, and a patient physical dimension.

58. The client side system of claim 57 wherein the memory subsystem further stores instructions executable by the processor subsystem to remotely transmit modification requests requesting modification of the multi-dimensional digital model via the communications subsystem.

59. The client side system of claim 57 wherein the memory subsystem further stores instructions executable by the processor subsystem to remotely transmit patient information including at least one of a patient gender, a patient age, a unique patient identifier, a dosage, and a patient physical dimension via the communications subsystem.

57. A client side system for designing biomedical devices, comprising:

a communications subsystem couplable to a communications channel;

a display subsystem;

a processor subsystem; and

a memory subsystem storing instructions executable by the processor subsystem to receive radiological data representing a physical structure of an anatomical body part from a radiological transducer, to securely transmit the radiological data remotely via the communications subsystem, to receive a multi-dimensional digital model of at least a portion of the anatomical body part incorporating structure not available in the radiological data via the communications subsystem, and to display the multi-dimensional digital model via the display subsystem; and

a bus coupling the processor subsystem, memory subsystem, display subsystem and communications subsystem.

60. A computing system for biomedical device design, comprising:

a client side computing system configured to transmit radiological data, patient information and requests for modifications, and configured to receive and visually display multi-dimensional digital models; and

a server side computing system configured to receive radiological data, patient information and requests for modifications from the client side computing system, and to produce the multi-dimensional models based on the received radiological data, patient information and requests for modifications.

61. The method of claim 60 wherein the server side computing system is further configured to receive approval of multi-dimensional digital models and to create a set of machine instructions from the approved multi-dimensional digital model.

62. The method of claim 60 wherein the server side computing system is further configured to select a biomedical device on a best fit basis from at least two previously manufactured biomedical devices, where the previously manufactured biomedical devices have differing sets of dimensions from one another.

63. The method of claim 60 wherein the server side computing system is further configured to successively incorporate a digital representation of each of at least two previously manufactured biomedical devices having differing dimensions from one another into the multi-dimensional digital model to allow a best fit comparison.

64. A computer-readable media for causing a computing system to automate the customized design of anatomically correct implants, by:

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

creating an initial 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, the first successive multi-dimensional model representing at least one physical characteristic of the anatomical body part not represented in the radiological data.

65. A computer-readable media for causing a computing system to automate the customized design of anatomically correct implants, by:

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

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

modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model, the first successive multi-dimensional model representing at least one physical characteristic of the anatomical body part not represented in the radiological data; and

creating a set of machine instructions based on at least one of the successive multi-dimensional digital models.

66. A computer-readable media for causing a computing system to automate customized design and manufacture of an anatomically correct implant for a patient, by:

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

providing the radiological data remotely from the capture;

providing patient information remotely over a communications channel; and

receiving an implant having at least some physical characteristics corresponding the radiological data and at least one physical characteristic not represented in the radiological data and derived from the patient related information.

67. A computer-readable media for causing a computing system 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.

68. A computer-readable media for causing a computing system automate customized design of biomedical devices, by:

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; and

receiving an approval of the multi-dimensional digital model.

69. A computer-readable media for causing a computing system automate manufacturing and selling customized medical devices via a computer network, by:

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

manufacturing a medical device based on the transmitted data;

delivering the medical device; and

maintaining records of the patient-specific data.

70. A computer-readable media for causing a computing system 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.

72. The biomedical product of claim 70 wherein the at least one physical characteristic of the anatomical body part not represented in the radiological data is an internal structure.

73. The biomedical product of claim 70 wherein the at least one physical characteristic of the anatomical body part not represented in the radiological data is a density gradient.

74. The biomedical product of claim 70 wherein the biomedical product is at least one of an oral implant, a maxillofacial implant and a mandibular implant.

75. The biomedical product of claim 70 wherein the biomedical product is at least one of an alveolar ridge replacement or an alveolar ridge augmentation.

76. The biomedical product of claim 70 wherein the biomedical product is an oral dosage form.

77. The biomedical product of claim 70 wherein the biomedical product is an implantable drug delivery device.

78. The biomedical product of claim 70 wherein providing a set of machine instructions based on at least one of the successive multi-dimensional digital models includes converting the multi-dimensional digital model into a set of three-dimensional printer commands.

79. The biomedical product of claim 70 wherein providing a set of machine instructions based on at least one of the successive multi-dimensional digital models includes selecting the set of machine instructions from a number of defined sets of machine instructions.

71. A biomedical product made by the process 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;

modifying the multi-dimensional digital model to create at least a first successive multi-dimensional model, the first successive multi-dimensional model representing at least one physical characteristic of the anatomical body part not represented in the radiological data; and

providing a set of machine instructions based on at least one of the successive multi-dimensional digital models.