Joint arthroplasty devices and surgical tools

• US 8,551,169 B2
• Filed: 09/24/2012
• Issued: 10/08/2013
• 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:
  US13/625,694
• Publication Number:
  US 20130030419A1
• Time in Patent Office: 379 Days
• Field of Search: 703/6, 703/11, 623 1911- 1914, 623/14.12, 623/17.16, 623/11.11, 623/21.11, 128/898, 600/407, 600/410, 606/86.R, 606/88, 606/87, 606/1, 295/92
• US Class Current: 623/14.12
• 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 generating a patient-matched surgical tool, the method comprising:

obtaining first magnetic resonance image data associated with at least a portion of a joint of a patient;

obtaining second magnetic resonance image data associated with at least a portion of a second joint;

deriving an electronic model of at least a portion of the joint using at least the first magnetic resonance image data;

creating a surgical tool using, at least in part, the electronic model;

wherein the tool includes a contact surface substantially matched to a corresponding surface of the joint and a guide for directing movement of a surgical instrument; and

wherein the position or orientation of the guide relative to the contact surface is adapted at least in part based on information derived from the second magnetic resonance image data.

2. A method of generating a patient-matched surgical tool, the method comprising:

obtaining first image data associated with at least a portion of a joint of a patient;

obtaining magnetic resonance image data associated with at least a portion of at least one second joint;

deriving an electronic model of at least a portion of the joint using at least the first image data;

creating a surgical tool using, at least in part, the electronic model;

wherein the tool includes a contact surface substantially matched to a corresponding surface of the joint and a guide for directing movement of a surgical instrument; and

wherein the position or orientation of the guide relative to the contact surface is adapted at least in part based on information derived from the magnetic resonance image data.

3. The method of claim 2, wherein the joint is one of a hip joint, knee joint, and ankle joint.

4. The method of claim 2, further comprising identifying an anatomical landmark using the magnetic resonance image data.

5. The method of claim 4, further comprising utilizing the landmark at least in part to determine an anatomic or biomechanical axis associated with the joint.

6. The method of claim 4, wherein the landmark is selected from the group consisting of a centroid of a tibial shaft of the patient, an intercondylar notch of the patient, an ankle joint of the patient, and a centroid of a femoral head of the patient.

7. The method of claim 2, wherein the first image data is image data of the joint in a weight-bearing condition.

8. The method of claim 2, wherein the magnetic resonance image data is a full length image of a leg associated with the joint.

9. The method of claim 2, wherein the first image data is image data of the joint in a lying or non-weight-bearing position.

10. The method of claim 2, further comprising estimating biomechanical axis at least in part from the magnetic resonance image data.

11. The method of claim 2, wherein the magnetic resonance image data is image data obtained with the joint in a lying or non-weight-bearing position.

12. The method of claim 11, wherein the joint of the patient is a knee joint and wherein the non-weight-bearing image data includes image data of a hip joint and/or an ankle joint associated with the knee joint.

13. The method of claim 2, further comprising determining a desired position of an implant.

14. The method of claim 13, wherein the guide is aligned based at least in part on the determined position of the implant.

15. The method of claim 2, further comprising determining a desired position of an implant based at least in part on an epicondylar axis of the joint and wherein the guide is aligned based at least in part on the desired position of the implant.

16. The method of claim 2, further comprising determining a position of an implant based at least in part on an anteroposterior axis of the joint and wherein the guide is aligned based at least in part on the determined position of the implant.

17. The method of claim 2, further comprising determining a position of an implant based at least in part on a posterior condylar axis and wherein the guide is aligned based at least in part on the determined position of the implant.

18. The method of claim 2, further comprising determining a rotational position of an implant and wherein the guide is aligned based at least in part on the determined rotational position of the implant.

19. The method of claim 2, further comprising determining a size of an implant.

20. The method of claim 19, wherein the guide is aligned based at least in part on the determined size of the implant.

21. The method of claim 2, further comprising determining a dimension of an implant.

22. The method of claim 21, wherein the guide is aligned based at least in part on the determined dimension of the implant.

23. The method of claim 2, further comprising determining a mechanical axis of the joint from the magnetic resonance image data.

24. The method of claim 2, further comprising determining an anatomical axis of the joint from the magnetic resonance image data.

25. The method of claim 2, wherein the magnetic resonance image data includes data from a series of two dimensional images.

26. The method of claim 2, wherein the magnetic resonance image data is obtained from a three dimensional data acquisition.

27. The method of claim 2, further comprising incorporating information regarding a surgical plan and wherein the surgical tool is created based at least in part on the information.

28. A method for making a patient specific surgical instrument for use in implanting an orthopedic implant in a patient, the process comprising:

determining at least in part from a first set of image data the surface contours of at least a portion of a surface of or near a joint of the patient;

determining at least in part from a set of magnetic resonance image data a mechanical axis associated with the joint;

incorporating a patient-specific surface into the surgical instrument such that the patient-specific surface substantially matches the determined surface contours; and

incorporating a guide into the surgical instrument, wherein the guide is oriented relative to the patient-specific surface based at least in part on the determined mechanical axis.

29. A method of creating a patient-specific instrument for implanting an orthopedic implant in or about a joint of a patient, the method comprising:

creating a patient-specific surgical instrument based at least in part on a first magnetic resonance image data set and a second image data set,

wherein the second image data set is of a type that is different from the first magnetic resonance image data set;

wherein the surgical instrument has a patient-specific surface that is derived from at least the first magnetic resonance image data and that substantially matches a corresponding surface portion associated with the joint; and

wherein the surgical instrument has a guide that is oriented relative to the patient-specific surface based on information derived from the second image data set.

30. The method of claim 29, wherein the second image data is x-ray image data.