Joint arthroplasty devices and surgical tools

• US 8,561,278 B2
• Filed: 09/24/2012
• Issued: 10/22/2013
• Est. Priority Date: 05/25/2001
• Status: Expired due to Term

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Fitz, Wolfgang, Lang, Philipp, Steines, Daniel
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US13/625,710
• Publication Number:
  US 20130081247A1
• Time in Patent Office: 393 Days
• Field of Search: 606/86.R, 606/87, 606/88, 606/89, 606 96- 98, 623/14.12, 623/18.11, 600/407, 600/410, 600/427, 128/898, 295/57, 295/271, 294/070.9
• US Class Current: 29/407.09
• CPC Class Codes: A61B 17/15 Guides therefor arrangements for guiding straight saw blades in general B23D51/025
• CPC Class Codes: A61B 17/154 for preparing bone for knee prosthesis
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 17/157 Cutting tibia
• CPC Class Codes: A61B 17/158 Cutting patella
• CPC Class Codes: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 17/1666 for the acetabulum
• CPC Class Codes: A61B 17/1668 for the upper femur A61B17/164 takes precedence
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/4504 : Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4514 : Cartilage
• CPC Class Codes: A61B 5/4528 : Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 6/508 : for non-human patients
• 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 2/30771 : 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 2/36 : Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3859 : Femoral components
• CPC Class Codes: A61F 2/4657 : Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/30062 : (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30894 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/3092 : having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30948 : using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30962 : using stereolithography
• CPC Class Codes: A61F 2002/3097 : using laser
• CPC Class Codes: A61F 2002/4631 : the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• 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 2310/00047 : Aluminium or Al-based alloys
• CPC Class Codes: A61F 2310/00065 : Manganese or Mn-based alloys
• CPC Class Codes: A61F 2310/00071 : Nickel or Ni-based alloys
• CPC Class Codes: A61F 2310/00077 : Copper or Cu-based alloys
• CPC Class Codes: A61F 2310/00083 : Zinc or Zn-based alloys
• CPC Class Codes: A61F 2310/00107 : Palladium or Pd-based alloys
• CPC Class Codes: A61F 2310/00113 : Silver or Ag-based alloys
• CPC Class Codes: A61F 2310/00119 : Tin or Sn-based alloys
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00143 : Iridium or Ir-based alloys
• CPC Class Codes: A61F 2310/00149 : Platinum or Pt-based alloys
• CPC Class Codes: A61F 2310/00155 : Gold or Au-based alloys
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00383 : Gelatin
• CPC Class Codes: A61F 2310/00395 : Coating or prosthesis-covering structure made of metals or of alloys
• CPC Class Codes: A61F 2310/00592 : Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
• CPC Class Codes: B23Q 17/00 : Arrangements for observing, indicating or measuring on machine tools for automatic control or regulation of feed movement, cutting velocity or position of tool or work B23Q15/00
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49764 : with testing or indicating
• CPC Class Codes: Y10T 29/49778 : with aligning, guiding, or instruction

Abstract

Disclosed herein are methods, compositions and tools for repairing articular surfaces repair materials and for repairing an articular surface. The articular surface repairs are customizable or highly selectable by patient and geared toward providing optimal fit and function. The surgical tools are designed to be customizable or highly selectable by patient to increase the speed, accuracy and simplicity of performing total or partial arthroplasty.

Claims

1. A method of manufacturing a patient-specific surgical tool for use in surgically repairing a diseased or damaged joint of a patient, comprising:

designing a patient-specific surface that substantially conforms to at least a portion of an articular cartilage surface of the joint, wherein the patient-specific surface is derived from information regarding articular cartilage of the joint and is further derived from information regarding subchondral bone of the joint; and

orienting a guide to define a cutting or drilling path having a predetermined position and orientation relative to the patient-specific surface and extending through at least a portion of the tissue of the joint when the patient-specific surface is aligned with and placed against the corresponding portion of the articular cartilage surface of the joint.

2. The method of claim 1, wherein the information regarding the articular cartilage of the joint is derived at least in part from image data of the joint of the patient.

3. The method of claim 1, wherein the information regarding the articular cartilage of the joint is derived at least in part from a first set of image data of the patient and information regarding the subchondral bone is derived at least in part from a second set of image data of the joint of the patient.

4. The method of claim 1, wherein the information regarding the articular cartilage of the joint is derived at least in part from a first source of data of the patient and information regarding the subchondral bone is derived at least in part from a second source of data of the joint of the patient.

5. The method of claim 4, wherein the first source of data includes x-ray image data, and the second source of data includes MRI image data.

6. The method of claim 4, wherein the first source of data includes x-ray image data, and the second source of data includes CT image data.

7. The method of claim 4, wherein the first source of data of the patient is a reference database.

8. The method of claim 7, wherein the second source of data of the patient includes MRI image data.

9. The method of claim 4, wherein the first or second source of data of the patient includes at least information regarding a body mass index of the patient.

10. The method of claim 4, wherein the first or second source of data of the patient includes at least information regarding a severity of disease of the joint of the patient.

11. The method of claim 4, wherein the first or second source of data of the patient includes at least information regarding a pain associated with the joint of the patient.

12. The method of claim 4, wherein the first source of data of the patient includes at least information regarding a deformity of the joint of the patient.

13. The method of claim 1, wherein the information regarding the articular cartilage includes information concerning thickness of the cartilage.

14. The method of claim 1, wherein the information regarding the articular cartilage includes information concerning estimated thickness of the cartilage.

15. The method of claim 1, wherein the information regarding the articular cartilage includes information concerning curvature of the cartilage.

22. The method of claim 1, wherein the information regarding the articular cartilage includes information concerning thickness of the cartilage.

23. The method of claim 1, wherein the information regarding the articular cartilage includes information concerning estimated thickness of the cartilage.

24. The method of claim 1, wherein the information regarding the articular cartilage includes information concerning curvature of the cartilage.

16. A method of manufacturing a patient-specific surgical tool for use in surgically repairing a diseased or damaged joint of a patient, comprising:

designing a patient-specific surface that substantially conforms to at least a portion of an articular surface of the joint, wherein the patient-specific surface is derived from information regarding articular cartilage of the joint and is further derived from information regarding subchondral bone of the joint; and

orienting a guide to define a cutting or drilling path having a predetermined position and orientation relative to the patient-specific surface and extending through at least a portion of tissue of the joint when the patient-specific surface is aligned with and placed against the corresponding portion of the articular surface of the joint.

17. The method of claim 16, wherein the information regarding the articular cartilage of the joint is derived at least in part from image data of the joint of the patient.

18. The method of claim 16, wherein the information regarding the articular cartilage of the joint is derived at least in part from a first set of image data of the patient and the information regarding the subchondral bone is derived at least in part from a second set of image data of the joint of the patient.

19. The method of claim 16, wherein the information regarding the articular cartilage or subchondral bone of the joint of the patient includes at least information regarding a score associated with the joint of the patient.

20. The method of claim 19, wherein the score associated with the joint of the patient is a score of osteoarthritis.

21. The method of claim 20, wherein the score of osteoarthritis includes information about cartilage loss or joint space narrowing.

25. A method of manufacturing a patient-specific surgical tool for use in surgically repairing a diseased or damaged joint of a patient, comprising:

designing a patient-specific surface that substantially conforms to at least a portion of a subchondral bone surface of the joint, wherein the patient-specific surface is derived from information regarding articular cartilage of the joint and is further derived from information regarding subchondral bone of the joint; and

orienting a guide to define a cutting or drilling path having a predetermined position and orientation relative to the patient-specific surface and extending through at least a portion of tissue of the joint when the patient-specific surface is aligned with and placed against the corresponding portion of the subchondral bone surface of the joint.

26. The method of claim 25, wherein the information regarding the subchondral bone is derived at least in part from image data of the joint of the patient.

27. The method of claim 25, wherein the information regarding the articular cartilage of the joint is derived at least in part from a first set of image data of the patient and information regarding the subchondral bone is derived at least in part from a second set of image data of the joint of the patient.

28. The method of claim 25, wherein the cartilage information regarding the articular cartilage includes information concerning thickness of the cartilage.

29. The method of claim 25, wherein the information regarding the articular cartilage includes information concerning estimated thickness of the cartilage.

30. A method of manufacturing a patient-specific surgical tool for use in surgically repairing a diseased or damaged joint of a patient, comprising:

designing, based on image data of the joint of the patient, a patient-specific surface that approximates, in at least a portion, an articular cartilage surface of the joint, wherein the articular cartilage surface is approximated using at least in part information about a subchondral bone surface of the joint derived from the image data and cartilage information based, at least in part, on data of the patient;

orienting a guide to define a cutting or drilling path having a predetermined position and orientation relative to the patient-specific surface and extending through at least a portion of tissue of the joint when the patient-specific surface is aligned with and placed against the corresponding portion of the surface of the joint.