PATIENT-SPECIFIC COMPUTED TOMOGRAPHY GUIDES

• US 20110218545A1
• Filed: 03/03/2011
• Published: 09/08/2011
• Est. Priority Date: 03/04/2010
• Status: Active Grant

• Current Assignee: Materialise NV
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Catanzarite, Joshua B., Schoenefeld, Ryan J.
• Granted Patent: US 9,066,727 B2
• Time in Patent Office: Days
• US Class Current: 606/96
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 17/56 Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• 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

Abstract

An orthopedic device for joint arthroplasty includes a patient-specific alignment guide constructed and configured for a specific patient from medical scans that show a bone surface of a bone of the patient without any overlying soft tissue. The patient-specific alignment guide includes a patient-specific inner surface configured to be offset from and mimic the bone surface and form a clearance for soft tissue overlying the bone surface. The alignment guide also includes a plurality of patient-specific contact areas configured to mate and register directly on the bone surface without intervening soft tissue for direct bone registration. The plurality of patient-specific contact areas includes non-contiguous surface contact areas.

Claims

1. An orthopedic device for joint arthroplasty comprising:

a patient-specific alignment guide constructed and configured for a specific patient from medical scans that show a bone surface of a bone of the patient without any overlying soft tissue, wherein the patient-specific alignment guide includes;

a patient-specific inner surface configured to be offset from and mimic the bone surface and form a clearance for soft tissue overlying the bone surface; and

a plurality of patient-specific contact areas configured to mate and register directly on the bone surface without intervening soft tissue for direct bone registration, and wherein the plurality of patient-specific contact areas includes non-contiguous surface contact areas.

2. The orthopedic device of claim 1, wherein the patient-specific alignment guide includes a plurality of patient-specific guiding formations having corresponding bores for guiding alignment pins or other tools therethrough.

3. The orthopedic device of claim 1, wherein the patient-specific alignment guide is a femoral guide and includes a reinforcing element between a pair of distal guiding formations of the plurality of guiding formations.

4. The orthopedic device of claim 1, wherein the patient-specific alignment guide is a tibial guide and includes a reinforcing element between a pair of anterior guiding formations of the plurality of guiding formations.

5. The orthopedic device of claim 1, wherein the patient-specific alignment guide is a tibial guide and includes an anterior flange extending distally from a pair of anterior guiding formations of the plurality of guiding formations, wherein the anterior flange provides another patient-specific surface contact area for direct bone registration.

6. The orthopedic device of claim 5, wherein the anterior flange includes a removable portion.

7. The orthopedic device of claim 6, wherein the removable portion is frangible along a score line.

8. The orthopedic device of claim 5, wherein the plurality of patient-specific contact areas includes contact areas registering on a tibial spine after removal of any overlying soft tissue.

9. The orthopedic device of claim 5, wherein the tibial guide includes a cutout under one of the anterior guiding formations configured to provide clearance for a patella tendon.

10. The orthopedic device of claim 2, wherein the patient-specific alignment guide is a femoral guide and wherein the femoral guide includes an arm extending medially from a distal portion of the femoral guide and includes a patient-specific contact surface area for direct bone registration on a medial portion of the tibia.

11. The orthopedic device of claim 10, wherein the arm is L-shaped and the distal portion of the femoral guide is adjacent to a distal guiding formation from the plurality of patient-specific guiding formations.

12. The orthopedic device of claim 1, wherein the patient-specific alignment guide is a femoral guide and wherein the femoral guide includes an extension extending at an angle away from the inner surface and configured to be directed toward the intercondylar notch to provide clearance for and avoid the posterior cruciate ligament.

13. The orthopedic device of claim 12, wherein the extension includes one of the plurality of the patient-specific surface contact areas for direct bone registration on an edge portion of the intercondylar notch.

14. The orthopedic device of claim 2, wherein the patient-specific alignment guide is a femoral guide and wherein the femoral guide includes a lateral anterior extension at an angle relative to a line defined by two anterior guiding formations from the plurality of guiding formations, the lateral anterior extension including one of the patient-specific surface contact areas for direct bone registration.

15. An orthopedic device for joint arthroplasty comprising:

a patient-specific alignment guide constructed and configured for a specific patient from medical scans that show a bone surface of a bone of the patient without any overlying soft tissue, wherein the patient-specific alignment guide includes;

a patient-specific inner surface configured to be offset from the bone surface and form a clearance for soft tissue overlying the bone surface;

a plurality of patient-specific contact areas configured to mate and register directly on the bone surface without intervening soft tissue for direct bone registration, and wherein the plurality of patient-specific contact areas includes non-contiguous surface contact areas;

a first pair of patient-specific guiding formations having corresponding bores for guiding a tool therethrough; and

a second pair of patient-specific guiding formations having corresponding bores for guiding a tool therethrough.

16. The orthopedic device of claim 15, wherein the patient-specific alignment guide is a femoral guide and wherein the first pair of guiding formations are anterior guiding formations and the second pair of guiding formations are distal guiding formations.

17. The orthopedic device of claim 16, wherein the plurality of patient-specific contact areas includes:

a medial anterior surface contact area;

a lateral anterior surface contact area;

a medial distal surface contact area; and

an intercondylar notch surface contact area.

18. The orthopedic device of claim 15, wherein the patient-specific alignment guide is a tibial guide and wherein the first pair of guiding formations are proximal guiding formations and the second pair of guiding formations are anterior guiding formations.

19. The orthopedic device of claim 18, wherein the plurality of patient-specific contact areas includes:

a first surface contact area configured to contact a tibial spine portion on a proximal surface of the tibia for direct bone registration after removal of the anterior cruciate ligament;

a second surface contact area configured to contact an anterior bone surface of the tibia.

20. The orthopedic device of claim 18, wherein the tibial guide includes a cutout under one of the distal formations configured to provide clearance for a patella tendon.

21. A method of manufacturing a patient-specific alignment guide comprising:

forming an inner surface of a patient-specific alignment guide to conform and mimic a bone surface of a patient'"'"'s bone;

offsetting the inner surface to avoid articular cartilage and other soft tissue; and

forming on the alignment guide a plurality of patient-specific contact areas for direct bone registration.