Joint arthroplasty devices and surgical tools

• US 8,551,102 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:
  US13/625,702
• Publication Number:
  US 20130023884A1
• Time in Patent Office: 379 Days
• Field of Search: 606/86.R, 606/88, 606/87, 606/89, 606/85, 606/84, 606/82, 623/14.12, 623/15.11, 623/23.61
• US Class Current: 606/88
• 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 patient-specific surgical tool for use in surgically repairing a diseased or damaged joint of a patient, comprising:

a mold and a guide;

the mold including a patient-specific surface that approximates at least a portion of an articular surface of the joint, the patient-specific surface including shape information of subchondral bone of the joint and cartilage information associated with the articular surface of the joint, wherein the shape information is derived from electronic image data of the joint; and

the guide including an aperture sized to accommodate a cutting or drilling tool and defining 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 a 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.

2. The patient specific surgical tool of claim 1, wherein the cartilage information is information of cartilage thickness associated with the joint.

3. The patient specific surgical tool of claim 1, wherein the cartilage information is information of cartilage shape associated with the joint.

4. The patient specific surgical tool of claim 1, wherein the cartilage information is a standard cartilage thickness associated with the joint.

5. The patient specific surgical tool of claim 2, wherein the cartilage thickness is based on information about the patient.

6. The patient specific surgical tool of claim 2, wherein the cartilage thickness varies along the patient-specific surface.

7. The patient specific surgical tool of claim 1, wherein the articular surface of the joint is a surface of a femoral condyle of a knee joint of the patient and the patient-specific surface includes an anterior zone portion and a weight-bearing zone portion corresponding respectively to an anterior articular surface of the condyle and a central weight bearing surface of the condyle.

8. The patient specific surgical tool of claim 2, wherein the articular surface of the joint is a surface of a femoral condyle of a knee joint of the patient and the patient-specific surface includes a posterior zone portion and a weight-bearing zone portion corresponding respectively to a posterior articular surface of the condyle and a central weight bearing surface of the condyle, and wherein the cartilage thickness is larger in the posterior portion than in the central weight bearing portion.

9. The patient specific surgical tool of claim 2, wherein the articular surface of the joint is a surface of a femoral condyle of a knee joint of the patient and the patient-specific surface includes an anterior zone portion, a central weight-bearing zone portion, and a posterior zone portion corresponding respectively to an anterior articular surface of the condyle, a central weight bearing surface of the condyle, and a posterior articular surface of the condyle, and wherein the cartilage thickness is smaller in the central weight-bearing portion of the patient-specific surface than in the anterior or posterior portions of the patient specific surface.

10. The patient specific surgical tool of claim 2, wherein the articular surface of the joint is a surface of a femoral condyle of a knee joint of the patient and the patient-specific surface includes an anterior zone portion and a weight-bearing zone portion corresponding respectively to an anterior articular surface of the condyle and a central weight bearing surface of the condyle, and wherein the cartilage thickness varies from the anterior zone portion to the central weight bearing zone portion of the patient-specific surface.

11. The patient specific surgical tool of claim 2, wherein the articular surface of the joint is a surface of a femoral condyle of a knee joint of the patient and the patient-specific surface includes a posterior zone portion and a weight-bearing zone portion corresponding respectively to a posterior articular surface of the condyle and a central weight bearing surface of the condyle, and wherein the cartilage thickness varies from the posterior zone portion to central weight bearing zone portion of the patient-specific surface.

12. The patient specific surgical tool of claim 2, wherein the articular surface of the joint is a surface of a femoral condyle of a knee joint of the patient and the patient-specific surface includes an anterior zone portion, a central weight-bearing zone portion, and a posterior zone portion corresponding respectively to an anterior articular surface of the condyle, a central weight bearing surface of the condyle, and a posterior articular surface of the condyle, and wherein the cartilage thickness varies from the anterior zone portion to the central weight-bearing zone portion of the patient-specific surface and from the central weight-bearing zone portion to the posterior zone portion of the patient-specific surface.

13. The patient specific surgical tool of claim 1, wherein the cartilage information is thickness and/or shape information of articular cartilage of the joint of the patient.

14. The patient specific surgical tool of claim 1, wherein the cartilage information is information characterizing diseased or damaged articular cartilage of the joint of the patient.

15. The patient specific surgical tool of claim 1, wherein the cartilage information is information characterizing the curvature of articular cartilage of the joint of the patient.

16. The patient specific surgical tool of claim 1, wherein the cartilage information is information characterizing articular cartilage of the joint of the patient in a weight-bearing position.

17. The patient specific surgical tool of claim 1, wherein the cartilage information is information characterizing articular cartilage of the joint of the patient in a non-weight-bearing position.

18. The patient specific surgical tool of claim 1, wherein the cartilage information is information characterizing articular cartilage of the joint of the patient in motion.

19. The patient specific surgical tool of claim 1, wherein the cartilage information is information characterizing articular cartilage of the joint of the patient in a combination of a weight-bearing position and in motion.

20. The patient specific surgical tool of claim 1, wherein the cartilage information is information characterizing articular cartilage of the joint of the patient in a combination of a weight-bearing position and a stationary position.

21. The patient specific surgical tool of claim 1, wherein the joint is a knee joint and the patient-specific surface is a first patient specific surface corresponding to at least a portion of a medial condyle of the knee joint, and further including a second patient-specific surface corresponding to at least a portion of a lateral condyle of the knee joint.

22. The patient specific surgical tool of claim 1, wherein the joint is a knee joint and the patient-specific surface corresponds to a tibial plateau of the knee joint.

23. The patient specific surgical tool of claim 21, wherein the second patient-specific surface approximates an articular surface of the lateral condyle of the joint, the second patient-specific surface including shape information of subchondral bone of the lateral condyle and cartilage information associated with the lateral condyle.

24. The patient specific surgical tool of claim 23, wherein the cartilage information of the first patient specific surface and the cartilage information of the second patient-specific surfaces includes cartilage thickness information of the medial and lateral respectively.

25. The patient specific surgical tool of claim 24, wherein the cartilage thickness information of the medial condyle is different than the cartilage thickness information of the lateral condyle.

26. The patient specific surgical tool of claim 1, wherein the position or orientation of the guide aperture is predetermined based on the cartilage information.

27. The patient specific surgical tool of claim 1, wherein said cartilage information includes information about residual cartilage on the subchondral bone of the joint.

28. A patient-specific surgical tool for use in surgically repairing a joint of a patient, comprising:

a block having a patient-specific surface and a guide;

the patient-specific surface having at least a portion that is substantially a negative of a corresponding portion of a diseased or damaged surface of the joint, wherein the patient specific surface includes information regarding cartilage thickness of the joint of the patient to estimate residual cartilage on the damaged or diseased surface of the joint, wherein the information is derived from electronic image data of the joint, and

the guide having a predetermined position and orientation relative to the corresponding portion, wherein the guide includes one or more apertures for drilling or cutting, the apertures having predetermined positions and orientations relative to the patient-specific surface and each having an axis that extends through a portion of the joint when the patient-specific surface is fit to the corresponding portion of the diseased of damaged articular surface of the joint.

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

a mold and a guide;

the mold including a patient-specific surface that approximates an articular cartilage surface of the joint, the patient-specific surface including shape information of subchondral bone of the joint and an estimation of cartilage thickness based on information about the patient, wherein the shape information is derived from electronic image data of the joint; and

the guide including an aperture sized to accommodate a cutting or drilling tool and defining 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 a corresponding portion of the diseased or damaged articular surface of the joint.

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

a mold and a guide;

the mold including a first patient-specific surface that approximates an articular cartilage surface of the joint, the patient-specific surface including shape information of subchondral bone of the joint and an estimation of cartilage thickness based on information about the patient, wherein the shape information is derived from electronic image data of the joint, and further including a second patient specific surface that substantially conforms to a corresponding surface portion of the joint of the patient; and

the guide including an aperture sized to accommodate a cutting or drilling tool and defining a cutting or drilling path having a predetermined position and orientation relative to the first and second patient-specific surfaces and extending through at least a portion of the tissue of the joint when the first and second patient-specific surfaces are aligned with and placed against corresponding portions of the surface of the joint.