Molded surgical implant and method

• US 6,786,930 B2
• Filed: 10/05/2001
• Issued: 09/07/2004
• Est. Priority Date: 12/04/2000
• Status: Expired due to Fees

• Current Assignee: Spineco, Inc.
• Original Assignee: Spineco, Inc.
• Inventors: Biscup, Robert S.
• Primary Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/971,395
• Publication Number:
  US 20040117015A1
• Time in Patent Office: 1,068 Days
• Field of Search: 623/901, 623/11.11, 623/16.11, 128/898, 433/223
• US Class Current: 623/16.11
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• 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 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• 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 2002/2853 Humerus
• CPC Class Codes: A61F 2002/30065 thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30233 Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30245 Partial spheres
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/3071 Identification means; Administration of patients
• CPC Class Codes: A61F 2002/30922 Hardened surfaces
• CPC Class Codes: A61F 2002/30925 etched
• 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 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2210/0071 : thermoplastic
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2250/0064 : Sets comprising a plurality of prosthetic parts of different sizes
• CPC Class Codes: A61F 2250/0085 : Identification means; Administration of patients
• CPC Class Codes: A61F 2250/0089 : coded with symbols, e.g. dots, numbers, letters, words
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: B29C 33/3842 : Manufacturing moulds, e.g. shaping the mould surface by machining
• CPC Class Codes: B29L 2031/7532 : Artificial members, protheses
• CPC Class Codes: G05B 19/4099 : Surface or curve machining, making 3D objects, e.g. desktop manufacturing
• CPC Class Codes: G05B 2219/36248 : Generate automatically machining, stitching points from scanned contour
• CPC Class Codes: G05B 2219/36251 : Superpose scanned or finished object image on workpiece model for best fitting
• CPC Class Codes: G05B 2219/45168 : Bone prosthesis
• CPC Class Codes: G05B 2219/45244 : Injection molding
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders
• CPC Class Codes: Y10S 623/901 : Method of manufacturing prosthetic device

Abstract

A customized prosthetic implant and method for producing a customized prosthetic implant for use in fully or partially replacing bone and/or tissue in a human or animal. The custom prosthetic implant is produced by obtaining information about the site of implant for the prosthetic implant, processing the obtained information to generate information on the size and shape of the prosthetic implant, and transferring at least a portion of the generated information to a molding machine to at least partially form the custom prosthetic implant from a moldable compound.

Claims

1. A method for producing a custom prosthetic implant for insertion into a patient comprising:

a. obtaining information about the site of implant for the prosthetic implant;

b. processing said obtained information to generate information on the size and shape of the prosthetic implant; and

,

c. transferring at least a portion of the generated information to a molding machine to at least partially form said custom prosthetic implant from a moldable compound, said molding machine including at least one mold cavity that can be varied in size and/or shape, said size and/or shape of said mold cavity altered based at least partially on said data transferred to said molding machine.

2. The method as defined in claim 1, wherein said step of obtaining information is at least partially by the use of at least one electronic scanner, said electronic scanner including a scanner selected from the group consisting of an MRI, ultrasonic device, x-ray machine, a camera, a scope and combinations thereof.

3. The method as defined in claim 1, wherein said step of processing said obtained information includes the use of at least one data processor.

4. The method as defined in claim 3, wherein said at least one data processor generates data to form a multi-dimensional representation of said prosthetic implant.

5. The method as defined in claim 4, including the step of manually modifying said generated data.

6. The method as defined in claim 3, wherein said at least one data processor generates at least one graphical representation of said prosthetic implant.

7. The method as defined in claim 1, wherein said step of transferring at least a portion oft he generated information to a molding machine includes a transmission device selected from the group consisting of wires, cables, electromagnetic waves, and combinations thereof.

8. The method as defined in claim 1, including the steps of flowing said moldable compound into at least one mold cavity and at least partially forming said prosthetic implant in said mold cavity and subsequently hardening at least a portion of said moldable compound.

9. The method as defined in claim 1, wherein said moldable compound is at least partially hardened by exposure to heat, radiation, catalysts, chemical reactants, electromagnetic waves, sound waves, and combinations thereof.

10. The method as defined in claim 1, wherein said moldable compound includes a material selected from the group consisting of bone, cartilage, calcium-phosphate compounds, ceramics, metals, polymers, co-polymers, resins, thermoplastics, and mixtures thereof.

11. The method as defined in claim 1, including the step of flowing multiple types of said moldable compounds into said at least one mold cavity.

12. The method as defined in claim 1, including the step of mixing at least one biological additive with said moldable compound with at least one of said moldable compounds prior to fully molding said moldable compound in said mold cavity.

13. The method as defined in claim 1, including the step of at least partially coating a surface of said prosthetic implant with a substance selected from the group consisting of a biological additive, cells, and combinations thereof.

14. The method as defined in claim 1, including the step of including readable information pertaining to said prosthetic implant on said prosthetic implant, said readable information including information selected from the group consisting of types of moldable material, size and shape information used to form the prosthetic implant, internal features of said prosthetic implant, type of additives included on and/or in said prosthetic implant, and combinations thereof.

15. The method as defined in claim 1, wherein said molding machine can form multiple types of prosthetic implants as well as multiple shaped and sized prosthetic implants for each of the types of said prosthetic implants.

16. The method as defined in claim 1, including the step of inserting at least one structural component in said molding cavity and at least partially coating said structural component with said moldable compound.

17. The method as defined in claim 1, including the step of selecting the shape and/or size of said structural component based at least partially on said obtained information.

18. The method as defined in claim 1, including the step of inserting at least one secondary component in said molding cavity and at least partially coating said structural component with said moldable compound.

19. The method as defined in claim 1, including the step of modifying at least a portion of said prosthetic implant after said prosthetic implant has been removed from said molding machine, said step including a step selected from the group consisting of labeling, cutting, smoothing, disinfecting, etching, and combinations thereof.

20. A method for producing a custom prosthetic implant for insertion into a patient comprising:

a. scanning a patient to obtain information about the site of implant for the custom prosthetic implant, said scanning including an MRI, an ultrasonic device, an x-ray machine, a camera, a scope, and combinations thereof;

b. processing said obtained information by the use of at least one data processor to generate information for a computer generated custom prosthetic implant having a particular multi-dimensional size and shape for insertion into the site of the implant;

c. transferring at least a portion of the generated information to a forming machine for use in at least partially forming a custom prosthetic implant from a moldable compound;

d. flowing said moldable compound having a generally soft putty property into at least one mold cavity to at least partially form said custom prosthetic implant in said mold cavity; and

,

e. finalizing the shape of said formed custom prosthetic implant to obtain a size and shape that substantially matches the size and shape of said computer generated prosthetic implant, said finalizing step including scanning said formed custom prosthetic implant subsequently modifying the shape and size of the custom prosthetic implant by a process which includes laser cutting, smoothing, minor sizing, etching, and combinations thereof.

21. The method as defined in claim 20, wherein said at least one data processor generates at least one graphical representation of said prosthetic implant.

22. The method as defined in claim 20, including the step of manually modifying said generated data.

23. The method as defined in claim 20, wherein said moldable compound substantially forms the complete custom prosthetic implant in said mold cavity.

24. The method as defined in claim 20, wherein said moldable compound is formed about a preexisting structure to form the complete custom prosthetic implant in said mold cavity.

25. The method as defined in claim 20, including the step of hardening at least a portion of said moldable compound.

26. The method as defined in claim 20, wherein said moldable compound includes a material selected from the group consisting of bone, cartilage, calcium-phosphate compounds, ceramics, metals, polymers, co-polymers, resins, thermoplastics, and mixtures thereof.

27. The method as defined in claim 20, including the step of mixing of at least one biological additive with said moldable compound.

28. The method as defined in claim 20, including the step of at least partially coating a surface of said prosthetic implant with a substance selected from the group consisting of a biological additive, cells, and combinations thereof.

29. The method as defined in claim 20, including the step of including readable information pertaining to said prosthetic implant on said prosthetic implant, said readable information including information selected from the group consisting of types of moldable material, size and shape information used to form the prosthetic implant, internal features of said prosthetic implant, type of additives included on and/or in said prosthetic implant, and combinations thereof.