Joint arthroplasty devices and surgical tools

• US 8,562,618 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:
  US13/625,742
• Publication Number:
  US 20130096562A1
• Time in Patent Office: 393 Days
• Field of Search: 623/14.12, 623/20.3, 623/20.31, 623/20.32, 623/20.35, 623/901, 606/96, 606/86.R, 606/88, 606/87, 606/89, 606/79, 600/407, 600/410, 600/427, 295/271, 295/57
• 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 tool for use in surgery on a tibia of a diseased or damaged knee joint of a patient, comprising:

a tibial mold having a patient-specific surface and a guide;

the patient-specific surface having at least a portion that substantially matches at least a corresponding portion of a surface of a tibial spine of the knee joint of the patient;

the guide being sized to accommodate a cutting tool and having a position and orientation relative to the patient-specific surface such that, when the patient-specific surface is placed against and substantially matched to the surface of the tibial spine, the guide defines a planar cutting path extending through at least a portion of the proximal end of the tibia along a predetermined path.

2. The tool of claim 1, further comprising a second patient-specific surface that substantially matches at least a portion of a cartilage surface of the tibia.

3. The tool of claim 1, further comprising a second patient-specific surface that substantially matches at least a portion of a subchondral bone surface of the tibia.

4. The tool of claim 1, further comprising a second patient-specific surface that substantially matches at least a portion of a cortical bone surface of the tibia.

5. The tool of claim 1, further comprising a second patient-specific surface that substantially matches at least a portion of an articular surface of the tibia.

6. The tool of claim 1, further comprising a second patient-specific surface that substantially matches at least a portion of another surface of the tibia, wherein the second patient-specific surface is contiguous with the patient-specific surface.

7. The tool of claim 1, further comprising a second patient-specific surface that substantially matches at least a portion of another surface of the tibia, wherein the second patient-specific surface is not contiguous with the patient-specific surface.

8. The tool of claim 1, further comprising:

a second patient-specific surface that substantially matches at least a portion of a cartilage surface of the tibia, and

first and second holes defining first and second drilling paths extending through tissue of the tibia along predetermined paths and including information of the knee joint of the patient, wherein the information defines rotation of an implant configured to repair the knee joint of the patient.

9. The tool of claim 1, further comprising first and second holes defining first and second drilling paths extending through tissue of the tibia along predetermined paths and including information of the knee joint of the patient, wherein the information defines rotation of an implant configured to repair the knee joint of the patient.

10. The tool of claim 1, further comprising:

a second patient-specific surface that substantially matches at least a portion of a cartilage surface of the tibia, and

first and second holes defining first and second drilling paths extending through tissue of the tibia along predetermined paths and including information of the knee joint of the patient, wherein the information defines alignment of an implant configured to repair the knee joint of the patient.

11. The tool of claim 1, further comprising first and second holes defining first and second drilling paths extending through tissue of the tibia along predetermined paths and including information of the knee joint of the patient, wherein the information defines alignment of an implant configured to repair the knee joint of the patient.

12. The patient-specific tool of claim 1, wherein the mold is shaped to extend along an entire anteroposterior length of a medial tibial plateau of the tibia.

13. The patient-specific tool of claim 1, wherein the mold is shaped to extend along an entire anteroposterior length of a lateral tibial plateau of the tibia.

14. The patient-specific tool of claim 1, wherein the tool includes information about other joints or extremities of the patient defining an orientation of the guide.

15. The patient-specific tool of claim 1, wherein the patient-specific surface substantially matches additional anatomical reference points of the tibia.

16. A patient-specific surgical tool for use in surgery on a knee joint of a patient, comprising

a cutting block having first and second patient-specific surfaces and a guide aperture;

the first patient-specific surface having at least a portion that substantially matches the geometry of at least a portion of a surface of a tibial spine of the joint of the patient, and the second patient-specific surface having at least a portion that matches the geometry of a cartilage surface of the tibia of the knee joint of the patient;

the guide aperture being sized to accommodate a cutting or drilling tool and having a position and orientation relative to the first and second patient-specific surfaces such that, when the first and second patient-specific surfaces are placed against and aligned with the corresponding cartilage and tibial spine surfaces, the guide aperture has a predetermined alignment relative to a biomechanical or anatomical axis and defines a cutting or drilling path extending through at least a portion of the proximal end of the tibia at a predetermined slope relative to the cartilage surface.

17. The tool of claim 16, further comprising first and second holes defining first and second drilling paths extending through tissue of the tibia along predetermined paths and including information of the joint of the patient defining at least one of an implant rotation and/or an implant alignment.

18. The tool of claim 16, wherein the cutting block includes an attachment mechanism, and further comprising a surgical cutting guide attachable to the cutting block by the attachment mechanism, the cutting guide defining a predetermined cutting path relative to the cutting block when the cutting guide is attached to the cutting block.

19. A patient-specific surgical tool for use in surgery on a knee joint of a patient, comprising

a cutting block having first and second patient-specific surfaces and a guide aperture;

the first patient-specific surface having at least a portion that substantially matches the geometry of at least a portion of a surface of a tibial spine of the joint of the patient, and the second patient-specific surface having at least a portion that matches the geometry of a second tibial surface of the knee joint of the patient;

the guide aperture being sized to accommodate a cutting tool and having a position and orientation relative to the first and second patient-specific surfaces such that, when the first and second patient-specific surfaces are placed against and aligned with the corresponding tibial spine and second tibial surfaces, the guide aperture has a predetermined alignment relative to a biomechanical or anatomical axis and defines a planar cutting path extending through at least a portion of the proximal end of the tibia at a predetermined slope relative to the second tibial surface.

20. The tool of claim 19, further comprising a third patient-specific surface that substantially matches at least a portion of at least one of a cartilage surface of the tibia, a subchondral bone surface of the tibia and a cortical bone surface of the tibia.

21. The tool of claim 19, further comprising a third patient-specific surface that substantially matches at least a portion of another surface of the tibia, wherein the second patient-specific surface is contiguous with the patient-specific surface.

22. The tool of claim 19, further comprising a third patient-specific surface that substantially matches at least a portion of another surface of the tibia, wherein the second patient-specific surface is not contiguous with the patient-specific surface.

23. The tool of claim 19, further comprising:

a third patient-specific surface that substantially matches at least a portion of a cartilage surface of the tibia, and

first and second holes defining first and second drilling paths extending through tissue of the tibia along predetermined paths and including information of the joint of the patient defining an implant rotation.

24. The tool of claim 19, further comprising first and second holes defining first and second drilling paths extending through tissue of the tibia along predetermined paths and including information of the joint of the patient defining an implant rotation.

25. The tool of claim 19, further comprising first and second holes defining first and second drilling paths extending through tissue of the tibia along predetermined paths and including information of the joint of the patient defining an implant alignment.

26. The patient-specific tool of claim 19, wherein the cutting block is shaped to extend along an entire anteroposterior length of a medial tibial plateau of the tibia.

27. The patient-specific tool of claim 19, wherein the tool includes information about other joints or extremities of the patient defining an orientation of the guide.

28. A patient-specific surgical tool for surgery on a tibia of a patient, comprising:

a mold having a patient-specific surface, wherein at least a portion of the patient-specific surface is substantially a negative of a surface of a tibial spine of a diseased or damaged knee joint of the patient;

a block having a guide aperture sized to accommodate a cutting or drilling tool; and

an attachment mechanism, wherein the block is attachable to the mold in a predetermined position relative to the patient-specific surface such that, when the patient-specific surface is placed against and aligned with the surface of the tibial spine, the guide aperture is aligned along a plane through the tibia to provide a cutting or drilling path for the cutting or drilling tool at a predetermined distance from a surface of the tibia.

29. The tool of claim 28, further comprising first and second holes defining first and second drilling paths extending through tissue of the tibia along predetermined paths and including information of the joint of the patient defining at least one of an implant rotation and an implant alignment.

30. The tool of claim 28, wherein the tibial mold includes an attachment mechanism, and further comprising a surgical cutting guide attachable to the tibial mold by the attachment mechanism, the cutting guide defining a predetermined cutting path relative to the tibial mold when the cutting guide is attached to the tibial mold.