Implants for altering wear patterns of articular surfaces

• US 8,682,052 B2
• Filed: 03/05/2009
• Issued: 03/25/2014
• Est. Priority Date: 03/05/2008
• Status: Active Grant

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Fitz, Wolfgang, Bojarski, Raymond, Lang, Philipp
• Primary Examiner(s): Weiss, Howard
• Assistant Examiner(s): SKYLES, TIFNEY L
• Application Number:
  US12/398,598
• Publication Number:
  US 20090226068A1
• Time in Patent Office: 1,846 Days
• Field of Search: 382/128, 382/131, 703/1, 623/16.11
• US Class Current: 382/131
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• 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 2/3603 implanted without ablation of the whole natural femoral head endoprosthetic cartilage A61F2/30756
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2/3877 Patellae or trochleae
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/4081 Glenoid components, e.g. cups
• CPC Class Codes: A61F 2/488 Means for detecting or monitoring wear
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• 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 2002/30324 differing in thickness
• CPC Class Codes: A61F 2002/30757 made of a sheet covering the natural articular surface, e.g. cap
• CPC Class Codes: A61F 2002/30761 Support means for artificial cartilage, e.g. cartilage defect covering membranes
• CPC Class Codes: A61F 2002/30878 with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30879 Ribs
• CPC Class Codes: A61F 2002/30884 Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30891 : Plurality of protrusions
• CPC Class Codes: A61F 2002/30894 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/3093 : for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30934 : Special articulating surfaces
• CPC Class Codes: A61F 2002/30939 : Means for modifying the geometry of articulating surfaces, e.g. for compensating excessive clearance caused by wear
• CPC Class Codes: A61F 2002/30943 : using mathematical models
• 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 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/3096 : trimmed or cut to a customised size
• CPC Class Codes: A61F 2002/3895 : unicompartimental
• CPC Class Codes: A61F 2002/4633 : for selection of endoprosthetic joints or for pre-operative planning
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0071 : thermoplastic
• 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 2310/00047 : 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 2310/00149 : Platinum or Pt-based alloys
• CPC Class Codes: A61F 2310/00155 : Gold or Au-based alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: B33Y 70/00 : Materials specially adapted for additive manufacturing
• CPC Class Codes: B33Y 70/10 : Composites of different types of material, e.g. mixtures of ceramics and polymers or mixtures of metals and biomaterials
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing

Abstract

Methods and devices for correcting wear pattern defects in joints. The methods and devices described herein allow for the restoration of correcting abnormal biomechanical loading conditions in a joint brought on by wear pattern defects, and also can, in embodiments, permit correction of proper kinematic movement.

Claims

1. A method for designing an orthopedic device that alters a wear pattern on an articular surface of a joint of a patient, comprising:

a) receiving image data associated with the joint of the patient;

b) determining a wear pattern of an articular surface of the joint of the patient at least in part from the image data; and

c) designing an orthopedic device based at least in part on the image data, wherein the orthopedic device is designed to alter the wear pattern of the articular surface to a revised wear pattern and configured to replace the articular surface of the joint of the patient.

2. The method of claim 1, wherein the image data is derived from one or more techniques selected from the group consisting of arthroscopy, arthrotomic examination, gait analysis, and imaging analysis.

3. The method of claim 1, wherein the step of designing includes altering the wear pattern at least in part by adjusting the location of the wear pattern on the articular surface.

4. The method of claim 1, wherein the step of designing includes altering the wear pattern at least in part by distributing the load that will be placed on the articular surface.

5. The method of claim 1, wherein the step of designing includes altering the wear pattern at least in part by reducing point loading on the articular surface.

6. The method of claim 1, wherein the image data is received via a computer network.

7. The method of claim 1, wherein the wear pattern is determined automatically.

8. The method of claim 1, further comprising determining a second wear pattern of a second articular surface of the joint from the image data.

9. The method of claim 8, further comprising designing the orthopedic device based at least in part on the image data associated with the second articular surface, wherein the orthopedic device is designed to alter the second wear pattern of the second articular surface to a second revised wear pattern.

10. The method of claim 9, wherein the joint is a knee joint and wherein the orthopedic device is a bicompartmental resurfacing device for the knee joint.

11. The method of claim 8, further comprising designing a second orthopedic device based at least in part on the image data associated with the second articular surface, wherein the second orthopedic device is designed to alter the second wear pattern of the second articular surface to a second revised wear pattern.

12. The method of claim 11, wherein the joint is a knee joint of the patient and wherein the first orthopedic device is a tibial implant for the knee joint and the second orthopedic device is a femoral implant for the knee joint, wherein the tibial implant and the femoral implant include mating articular surfaces configured to alter the wear pattern and the second wear pattern.

13. The method of claim 1, further comprising designing a second orthopedic device based at least in part on the image data, wherein the second orthopedic device is designed to alter the wear pattern of the articular surface to the revised wear pattern.

14. The method of claim 13, wherein the orthopedic device is a tibial implant for a knee joint and the second orthopedic device is a femoral resurfacing device for the knee joint, wherein the tibial implant and the femoral resurfacing device include mating articular surfaces configured to alter the wear pattern.

15. The method of claim 1, wherein the joint is a hip joint of the patient, wherein the orthopedic device is a hip joint replacement device.

16. The method of claim 15, wherein the hip joint replacement device includes a femoral component and an acetabular component.

17. The method of claim 1, wherein the orthopedic device is designed using a library of design elements.

18. The method of claim 1, wherein the orthopedic device is designed to include at least one surface that conforms to an existing surface of the joint.

19. The method of claim 1, wherein the orthopedic device is designed to include at least one surface that is derived from an existing surface of the joint.

20. The method of claim 19, wherein the derived surface excludes a defect of the existing surface.

21. The method of claim 19, wherein the derived surface approximates an ideal surface of the joint.

22. The method of claim 19, wherein the derived surface approximates a healthy surface of the joint.

23. The method of claim 1, wherein the orthopedic device is designed to include at least one curve derived from an existing surface of the joint.

24. The method of claim 23, wherein the derived curve excludes a defect of the existing joint.

25. The method of claim 23, wherein the derived curve approximates an ideal curve of the joint.

26. The method of claim 23, wherein the derived curve approximates a healthy surface of the joint.

27. The method of claim 1, wherein the orthopedic device is designed to include at least one dimension that is derived from an existing dimension of the joint.

28. The method of claim 27, wherein the derived dimension excludes a defect of the existing joint.

29. The method of claim 27, wherein the derived dimension approximates an ideal dimension of the joint.

30. The method of claim 27, wherein the derived dimension approximates a dimension associated with a healthy joint.

31. The method of claim 1, wherein the orthopedic device is designed to be placed at least in part on cartilage associated with the joint.

32. The method of claim 1, wherein the orthopedic device is designed to be placed at least in part on subchondral bone associated with the joint.

33. The method of claim 1, further comprising producing the orthopedic device.

34. The method of claim 33, wherein the orthopedic device is produced using direct digital manufacturing.

35. The method of claim 33, wherein the orthopedic device is produced by tailoring a precursor orthopedic device.

36. The method of claim 35, wherein the precursor orthopedic device is selected from a library of orthopedic devices.

37. The method of claim 33, wherein the orthopedic device is produced by altering a standard orthopedic device.

38. The method of claim 37, wherein the standard orthopedic device is selected from an inventory of orthopedic devices.

39. The method of claim 1, wherein the orthopedic device includes at least two mating articular surfaces configured to replace the articular surface and its opposing articular surface of the joint, wherein the at least two mating articular surfaces are designed to alter the wear pattern to the revised wear pattern.

40. The method of claim 1, wherein a surface of the orthopedic device is adapted or optimized based on the wear patter.

41. The method of claim 40, wherein the adaptation or optimization includes one or more changes selected from the group consisting of:

a change in material thickness;

a change in material composition;

a change in cross-linking properties;

a change in a shape of the orthopedic device;

enhanced constraint of mating articular surfaces of the orthopedic device;

decreased constraint of mating articular surfaces of the orthopedic device; and

any combination thereof.

42. A method for preparing a joint replacement implant for correcting an articular surface wear pattern of a patient'"'"'s joint, comprising:

a) obtaining electronic image data of an articular surface of the patient'"'"'s joint;

b) analyzing the image data for the presence or absence of wear pattern indicia;

c) determining a wear pattern from the wear pattern indicia; and

d) providing an implant configured to replace the articular surface of the patient'"'"'s joint, wherein the implant has a characteristic topography for correcting the wear pattern to a revised wear pattern.

43. A method of creating an implant for use in joint arthroplasty to repair a patient'"'"'s joint, the method comprising:

a) obtaining electronic image data of an articular surface of the patient'"'"'s joint, the articular surface of the patient'"'"'s joint including a wear pattern;

b) deriving a shape of the articular surface based, at least in part, on the image data; and

c) providing an implant having a surface based on the shape of the articular surface and configured to replace the articular surface of the patient'"'"'s joint, wherein the implant is configured to alter the wear pattern of the joint to a revised wear pattern.

44. The method of claim 43, wherein the image data is derived from one or more imaging techniques selected from the group consisting of x-ray imaging and processing;

fluoroscopy;

digital tomosynthesis;

ultrasound;

optical coherence, conventional, cone beam, or spiral computed tomography (CT);

single photon emission tomography (SPECT);

bone scan;

positron emission tomography (PET);

magnetic resonance imaging (MRI);

thermal imaging; and

optical imaging.

45. The method according to claim 43, wherein the patient'"'"'s joint is a joint selected from the group consisting of a knee, a shoulder, a hip, a vertebrae, an elbow, an ankle, a foot, a toe, a hand, a wrist and a finger.

46. The method according to claim 43, wherein the wear pattern is based, at least in part, on one of a presence, absence, location, distribution, depth, area, or dimensions of cartilage loss;

presence, absence, location, distribution, depth, area, or dimensions of subchondral cysts;

presence, absence, location, distribution, depth, area, or dimensions of subchondral sclerosis;

presence, absence, location, distribution, volume, area, depth or dimensions of a subchondral bone plate abnormality;

presence, absence, location, distribution, or dimensions of a subchondral bone deformity;

presence, absence, or severity of a varus or valgus deformity;

presence, absence or severity of recurvatum or antecurvatum; and

presence, absence, location, distribution, volume, depth or dimensions of bone marrow edema.

47. The method of claim 43, wherein the surface of the implant is substantially at least one of rigid, non-pliable, non-flexible and non-resilient.

48. The method of claim 43, wherein the surface of the implant comprises a material selected from the group consisting of a polymer, a cross-linked polymer, a ceramic, a metal, an alloy, a ceramic-metal composite, and combinations thereof.

49. The method of claim 43, wherein providing the surface of the implant includes a process selected from the group consisting of rapid prototyping, laser cutting, laser sintering, electron beam melting, casting, milling, and combinations thereof.

50. A method for preparing an implant for accommodating an articular surface wear pattern of a femoral condyle and/or a tibial plateau of a patient'"'"'s knee joint, comprising:

a) obtaining electronic image data of an articular surface of the femoral condyle and/or tibial plateau;

b) analyzing the image data for the presence or absence of wear pattern indicia;

c) determining a wear pattern from the wear pattern indicia; and

d) providing an implant having a surface with a characteristic topography for accommodating the wear pattern, wherein the implant is configured to replace at least a portion of the femoral condyle and/or the tibial plateau.

51. The method of claim 50, wherein a shape of the surface of the implant is derived from a shape of the articular surface derived from the electronic image data.

52. The method of claim 50, wherein the implant includes a femoral component and a tibial component having mating articular surfaces configured to alter the wear pattern to a revised wear pattern.