Patient-specific joint arthroplasty devices for ligament repair

• US 9,308,053 B2
• Filed: 07/30/2013
• Issued: 04/12/2016
• Est. Priority Date: 02/06/2006
• Status: Active Grant

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Bojarski, Raymond A., Lang, Philipp, Steines, Daniel, Fitz, Wolfgang
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US13/954,090
• Publication Number:
  US 20130317511A1
• Time in Patent Office: 987 Days
• Field of Search: 606 79- 85, 606/86.R, 606 87- 89, 606/96, 606/102, 128/898, 623/20.35, 623/901
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1714 for applying tendons or ligaments implements for applying tendons or ligaments A61F2/0805
• CPC Class Codes: A61B 17/1764 for the knee
• 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 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/1121 Determining geometric values, e.g. centre of rotation or angular range of movement
• 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 5/4533 Ligaments
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• 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

Abstract

Disclosed herein are methods, compositions and tools for repairing, replacing or otherwise treating bone ligaments using devices designed from patient-specific information, including without limitation, surgical alignment instruments that have a surface that conforms to at least a portion of a patient'"'"'s bone, cartilage or other component of the joint or ligament being treated.

Claims

1. A method for customizing ligament repair, the method comprising:

obtaining electronic image data of at least one surface associated with a ligament;

obtaining kinematic modeling and simulation, and optionally finite element modeling, involving the ligament; and

creating a first template based, at least in part, on the image data, and the kinematic modeling and simulation, the first template having at least one contact surface that conforms with at least a portion of the surface, the first template including at least one guide for directing movement of a surgical instrument involved with the ligament repair.

2. The method according to claim 1, wherein the ligament includes an anterior cruciate ligament, posterior cruciate ligament, or both.

3. The method according to claim 1, wherein determining the tunnel site includes identifying an origin of the ligament on a first articular surface, and an insertion position onto a second articular surface opposing the first articular surface.

4. The method according to claim 1, wherein determining the tunnel site includes identifying at least one of a bony landmark and a remainder of a ligament based on the image data.

5. The method according to claim 1, wherein the at least one surface is one of adjacent to the tunnel site and a non-weight bearing surface.

6. The method according to claim 1, wherein the first template includes a drill guide aperture.

7. The method according to claim 6, wherein at least one of the shape, position and orientation of the drill guide aperture on the first template is based, at least in part, on a distance of the tunnel site to adjacent cortical bone.

8. The method according to claim 7, wherein the drill guide aperture includes a stop, such that a desired drill depth is obtained.

9. The method according to claim 1, wherein the electronic image data is obtained in at least one of joint flexion, joint extension, joint abduction, joint adduction, and joint rotation.

10. The method according to claim 1, further comprising:

identifying a graft harvest site based on the image data; and

configuring the first template to guide harvesting of at least one of ligament and bone from the graft harvest site.

11. The method according to claim 1, further comprising:

creating a second template configured to cross-reference to the first template to align a position of the second template on a second surface associated with the ligament, the second template including at least one guide configured to direct movement of the surgical instrument using the at least one guide of the second template relative to said guide.

12. The method according to claim 11, wherein the at least one and second surfaces are opposing articular surfaces.

13. The method according to claim 11, wherein the at least one surface is a femoral surface and the second surface is a tibial surface.

14. The method according to claim 1, wherein the first template includes a tissue retractor.

15. The method according to claim 1, wherein the first template is configured for use in at least one of a single bundle and a double bundle ligament reconstruction.

16. The method according to claim 1, including creating the first template further based on finite element modeling.

17. A method for making a surgical instrument system for repairing an anterior cruciate ligament (ACL) of a patient'"'"'s knee joint, the method comprising:

obtaining electronic image data of at least one surface associated with the ACL;

determining a femoral tunnel site and a tibial tunnel site for a ligament graft based, at least in part, on the electronic image data; and

creating a first template based, at least in part, on the electronic image data and the kinematic modeling and simulation of the patient'"'"'s knee joint including the ACL, the first template having at least one contact surface that conforms with at least a portion of the at least one surface associated with the ACL, the first template including at least one guide for directing movement of a surgical instrument involved with the ACL repair, wherein the at least one guide is configured based, at least in part, on the femoral and tibial tunnel sites.

18. The method according to claim 17, wherein the femoral or tibial tunnel site is optimized for a knee pose angle.

19. The method according to claim 17, wherein the femoral or tibial tunnel site is optimized for a range of motion of the patient'"'"'s knee joint.

20. The method according to claim 17, including creating the first template further based on finite element modeling.