PERSONAL FIT MEDICAL IMPLANTS AND ORTHOPEDIC SURGICAL INSTRUMENTS AND METHODS FOR MAKING

• US 20070118243A1
• Filed: 10/16/2006
• Published: 05/24/2007
• Est. Priority Date: 10/14/2005
• Status: Abandoned Application

• Current Assignee: Vantus Technology Corporation
• Original Assignee: Vantus Technology Corporation
• Inventors: Schroeder, James, Goodman, Steven, Kim, Kyu-Jung
• Application Number:
  US11/549,928
• Publication Number:
  US 20070118243A1
• Time in Patent Office: Days
• US Class Current: 700/118
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/8061 specially adapted for particular bones A61B17/70 and A61B17/74 take precedence
• CPC Class Codes: A61B 17/8066 for pelvic reconstruction
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61C 13/0004 Computer-assisted sizing or machining of dental prostheses
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• 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 2/32 for the hip
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3609 Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts A61F2/3601 takes precedence
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/2889 Maxillary, premaxillary or molar implants
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30492 : using a locking pin
• CPC Class Codes: A61F 2002/30507 : using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2002/30879 : Ribs
• 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 2002/30955 : using finite-element analysis
• CPC Class Codes: A61F 2002/30962 : using stereolithography
• CPC Class Codes: A61F 2002/30968 : Sintering
• CPC Class Codes: A61F 2002/3097 : using laser
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/365 : Connections of heads to necks
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00185 : based on metal oxides
• CPC Class Codes: A61F 2310/00329 : Glasses, e.g. bioglass
• CPC Class Codes: A61N 1/375 : Constructional arrangements, e.g. casings
• 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: G05B 19/4099 : Surface or curve machining, making 3D objects, e.g. desktop manufacturing
• CPC Class Codes: G05B 2219/35017 : Finite elements analysis, finite elements method FEM
• CPC Class Codes: G05B 2219/35134 : 3-D cad-cam
• CPC Class Codes: G05B 2219/35219 : From cad data derive cutting, stacking, sorting program
• CPC Class Codes: G05B 2219/45168 : Bone prosthesis
• 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 50/50 : for simulation or modelling of medical disorders

Abstract

The present invention provides methods, techniques, materials and devices and uses thereof for custom-fitting biocompatible implants, prosthetics and interventional tools for use on medical and veterinary applications. The devices produced according to the invention are created using additive manufacturing techniques based on a computer generated model such that every prosthesis or interventional device is personalized for the user having the appropriate metallic alloy composition and virtual validation of functional design for each use.

Claims

1. A method of custom-fitting a biocompatible device, comprising the steps of:

(a) receiving input imaging data from a patient;

(b) calibrating, analyzing and producing a three-dimensional computer aided design solid model from the input imaging data; and

(c) manufacturing the biocompatible device from the digital three-dimensional solid model using additive manufacturing process, wherein the device is selected from a group consisting of an implant, a prosthesis, an interventional tool, or a surgical tool.

2. The method of custom-fitting a biocompatible device of claim 1, wherein input imaging data is received from MRI, X-Ray, CT, ultrasound, LASER interferometry or PET scanning of the patient.

3. The method of custom-fitting a biocompatible device of claim 1, wherein calibrating, analysis and constructing solid modeling from of input imaging data is performed through computer aided designing, computer aided manufacturing, finite element analysis of biological tissue of the patient, finite element analysis of materials, solid modeling or three-dimension visualization instruments and methods.

4. The method of custom-fitting a biocompatible device of claim 1, wherein the biocompatible device is manufactured by additive manufacturing process.

5. The method of custom-fitting a biocompatible device of claim 1, wherein the 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.

6. The method of custom-fitting a biocompatible device of claim 1, wherein the biocompatible device is selected from a group consisting of long bones, plates, intramedullary rods, pins, total joint prosthetics or portions thereof, pelvic reconstruction prosthesis, cranial reconstruction prosthesis, maxillofacial reconstruction prosthesis, dental prosthesis, external fixation device for aligning long bones and the spine, sliding joints, overlapping plates, external or implantable orthopedic intervention prosthesis, adjustable fixtures, internal Ilizarov device for enabling the expansion or lengthening of long bones, implantable non-orthopedic prosthesis for cardiovascular, neurological, digestive or interventional implant device for soft or hard tissue repair, cardiovascular stents, urological stents, interventional tools, interventional guides to assist accurate preparation of the tissue to enable the proper fit of the device, and instruments for laparoscopic, interventional, radiological, and minimally invasive procedures for cardiovascular, neurological, digestive applications in soft or hard tissues.

7. The method of custom-fitting a biocompatible device of claim 1, wherein the biocompatible device is manufactured from materials selected from a group consisting of Cobalt-Chromium-Molybdenum alloy, Titanium alloy, commercially pure Ti (cpTi), medical grade stainless steel, Tantalum, Tantalum alloy, Nitinol, ceramics, oxides, minerals, glasses and combinations thereof.

8. The method of custom-fitting a biocompatible device of claim 7, wherein the material is selected based on desirability of biomechanical properties and interaction with surrounding biological environment of the device.

9. The method of custom-fitting a biocompatible device of claim 1, wherein the device is manufactured using at least two materials which are fabricated sequentially, regionally, locally or in combinations thereof.

10. The method of custom-fitting a biocompatible device of claim 9, wherein the device is a bone prosthesis and the fabrication materials are Ti6 in combination with cpTi.

11. The method of custom-fitting a biocompatible device of claim 9, wherein the fabrication material is Nitinol (NiTi) alloy, wherein further the device surface is substantially Ti for minimizing Ni toxicity.

12. The method of custom-fitting a biocompatible device of claim 1, wherein the device is fabricated by additive manufacturing fabrication, whereby the fabricated device is further fabricated with an element.

13. The method of custom-fitting a biocompatible device of claim 12, wherein the element is a functional sensor, an optical element or a structural element.

14. The method of custom-fitting a biocompatible device of claim 1, wherein the element is a MEMS lens, optical lens, ceramic whisker or a curved external fixture for Ilizarov device.

15. The method of custom-fitting a biocompatible device of claim 1, wherein the biocompatible device has internal structure or surface selected from a group consisting of honeycombs, struts, ribs or combinations thereof.

16. The method of custom-fitting a biocompatible device of claim 1, wherein the biocompatible device is a supporting fixture for neck or spine trauma.

17. The method of custom-fitting a biocompatible device of claim 1, wherein the biocompatible device is a custom cast or an articulation brace device with adjustability where range can be slowly expanded.

18. The method of custom-fitting a biocompatible device of claim 1, wherein the biocompatible device is a surgical tool that fits to hand and motion mechanics.

19. A biocompatible device produced by the process of claim 1.

21. A method of custom-fitting a biocompatible device of claim 19, wherein the additive manufacturing process is laser additive manufacturing, laser engineered net shaping, selective laser sintering, electron-beam projection lithography, direct metal deposition or electron beam melting.

20. A method of custom-fitting a biocompatible device of, comprising the steps of:

(a) quantitatively calibrating a medical image;

(b) analyzing the calibrated medical image;

(c) compiling computer aided design (CAD) of the analyzed and calibrated medical image;

(d) creating computer aided manufacturing (CAM) for CAD of step (c);

(e) performing finite element analysis of biological tissues of CAM from step (d);

(f) performing finite element analysis of materials;

(g) performing solid modeling using 3D visualization instrumentation and virtual reality; and

(h) manufacturing the device using additive manufacturing processes.

22. A biocompatible device produced by the process of claim 20.