Patient selectable joint arthroplasty devices and surgical tools

• US 9,072,531 B2
• Filed: 11/05/2013
• Issued: 07/07/2015
• 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:
  US14/072,771
• Publication Number:
  US 20140074441A1
• Time in Patent Office: 609 Days
• Field of Search: 606/86.R, 606/88, 606/87, 606/96, 606/79, 606/99, 623/16.11, 623/20.11, 623/20.14, 623/20.34, 623/20.32, 623/14.12, 623/21.18, 623/23.47, 623/23.61, 295/92, 295/57, 295/271, 703/1
• US Class Current: 1/1
• 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 17/1666 for the acetabulum
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 17/1677 for the patella
• CPC Class Codes: A61B 17/1682 for the foot or ankle
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/1746 for the acetabulum
• CPC Class Codes: A61B 17/1767 for the patella
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• 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 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 5/4523 : Tendons
• CPC Class Codes: A61B 5/4528 : Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4533 : Ligaments
• 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 2/38 : for elbows or knees
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: G06F 30/00 : Computer-aided design [CAD]
• CPC Class Codes: G06F 30/10 : Geometric CAD
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture

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 for making a patient specific surgical tool based at least in part on a joint space in a joint of a patient, the method comprising:

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

measuring the joint space of the joint based at least in part on the image data;

generating a patient-specific surgical tool based in part on the joint space measurement;

wherein the surgical tool includes at least one surface portion having a shape that substantially conforms to a corresponding surface portion of the joint of the patient, and includes a surgical instrument guide having a predetermined position relative to the surface portion such that the surgical instrument guide defines a predetermined cutting or drilling path relative to the joint when the surface portion is aligned with and placed against the corresponding surface portion of the joint, wherein the joint of the patient is an ankle joint of the patient.

2. The method of claim 1, further comprising determining at least one of a mechanical and an anatomical axis associated with the joint.

3. The method of claim 1, wherein the image data is derived from an imaging selected from the group consisting of one of a CT scan, a MRI scan, an optical scan, an ultrasound imaging and any combination thereof.

4. The method of claim 1, wherein the image data is two dimensional image data.

5. The method of claim 1, wherein the joint space is determined at least in part using a single scan plane orientation.

6. The method of claim 1, wherein the joint space is determined at least in part using a single scan plane orientation in a sagittal plane of the joint.

7. The method of claim 1, wherein the joint space is determined at least in part using a single scan plane orientation in the coronal plane of the joint.

8. The method of claim 1, wherein the joint space is determined at least in part using a single scan plane orientation in the axial plane of the joint.

9. The method of claim 1, wherein the image data is three dimensional image data.

10. The method of claim 1, wherein the joint space is determined at least in part using at least two scan plane orientations.

11. The method of claim 1, wherein the joint space is determined at least in part using a first scan plane orientation in a sagittal plane and a second scan plane orientation in a coronal plane.

12. The method of claim 1, wherein the joint space is determined at least in part using the distance from the subchondral bone plate of one articular surface of the joint to the subchondral bone plate of an opposing articular surface of the joint.

13. The method of claim 1, wherein the joint space is determined at least in part using a cartilage thickness of the joint.

14. The method of claim 1, wherein the joint space is determined in more than one region of the joint.

15. The method of claim 1, wherein the joint space is determined in one or more positions from the group of anterior, posterior, medial, lateral, superior and inferior positions.

16. The method of claim 1, further comprising optimizing a desired postoperative correction based on the joint space of the joint.

17. The method of claim 1, further comprising optimizing a desired postoperative correction along a biomechanical or anatomical axis based on the joint space of the joint.

18. The method of claim 1, wherein the joint space is determined at least in part using a cartilage thickness of at least one articular surface of the joint.

19. The method of claim 18, wherein the cartilage thickness is determined in one or more positions from the group of anterior, posterior, medial, lateral, superior and inferior positions.

20. The method of claim 18, wherein the cartilage thickness is determined in more than one region of the joint.

21. The method of claim 18, further comprising optimizing a desired postoperative correction based on the cartilage thickness of the joint.

22. The method of claim 18, further comprising optimizing a desired postoperative correction along a biomechanical or anatomical axis based on the cartilage thickness of the joint.

23. The method of claim 1, further comprising combining information about the joint space with information about a biomechanical axis of the joint.

24. A method for making a patient specific surgical tool based at least in part on a joint space width in a joint of a patient, the method comprising:

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

determining a joint space width of the joint based at least in part on the image data; and

generating a surgical tool based in part on the joint space width;

wherein the surgical tool includes at least one surface portion having a shape that substantially conforms to a corresponding surface portion of the joint of the patient, and includes a surgical instrument guide having a predetermined position relative to the surface portion such that the surgical instrument guide defines a predetermined cutting or drilling path relative to the joint when the surface portion is aligned with and placed against the corresponding surface portion of the joint, wherein the joint of the patient is an ankle joint of the patient.

25. The method of claim 24, further comprising designing an implant based in part on the joint space width.

26. The method of claim 24, further comprising selecting an implant based in part on the joint space width.

27. A method for making a patient specific surgical tool based at least in part on a cartilage thickness in a joint of a patient, the method comprising:

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

determining a cartilage thickness of the joint at least in part from the image data; and

generating a surgical tool based in part on the cartilage thickness;

wherein the surgical tool includes at least one surface portion having a shape that substantially conforms to a corresponding surface portion of the joint of the patient, and includes a surgical instrument guide having a predetermined position relative to the surface portion such that the surgical instrument guide defines a predetermined cutting or drilling path relative to the joint when the surface portion is aligned with and placed against the corresponding surface portion of the joint, wherein the joint of the patient is an ankle joint of the patient.

28. The method of claim 27, further comprising designing an implant based in part on the cartilage thickness.

29. The method of claim 27, further comprising selecting an implant based in part on the cartilage thickness.

30. A method for making a patient specific surgical tool based at least in part on a joint space width in a joint of a patient, the method comprising:

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

determining a joint space width of the joint based at least in part on the image data;

estimating a cartilage loss of the joint based at least in part on the image data; and

generating a surgical tool based in part on the joint space width;

wherein the surgical tool includes at least one surface portion having a shape that substantially conforms to a corresponding surface portion of the joint of the patient, and includes a surgical instrument guide having a predetermined position relative to the surface portion such that the surgical instrument guide defines a predetermined cutting or drilling path relative to the joint when the surface portion is aligned with and placed against the corresponding surface portion of the joint, wherein the joint of the patient is an ankle joint of the patient.