Patient specific knee alignment guide and associated method

• US 8,282,646 B2
• Filed: 02/29/2008
• Issued: 10/09/2012
• Est. Priority Date: 02/27/2006
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Schoenefeld, Ryan J., Deming, Scott, Sheffer, Garrett A., Metzger, Robert
• Primary Examiner(s): Truong, Kevin T
• Assistant Examiner(s): BECCIA, CHRISTOPHER J
• Application Number:
  US12/039,849
• Publication Number:
  US 20080161815A1
• Time in Patent Office: 1,684 Days
• Field of Search: 606/86.R, 606 87- 89, 606/104, 623 2014- 2036
• US Class Current: 606/88
• 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 17/175 for preparing the femur for hip prosthesis insertion
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00911 for fields applied by a magnetic resonance imaging system
• CPC Class Codes: A61B 2017/0268 for the knee
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• CPC Class Codes: A61B 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 90/14 Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins

Abstract

An orthopedic apparatus including a patient-specific alignment guide attachable to a surface of a bone being prepared for receiving a prosthetic implant. The guide includes at least first and second components and a coupling mechanism connecting the first and second components to one another. The first component has a first bone engagement surface and the second component has a second bone engagement surface, the first and second bone engagement surfaces anatomically matching corresponding first and second portions of the surface of the bone. At least one of the first and second components defines at least one alignment formation.

Claims

1. An orthopedic apparatus comprising:

a multi-component patient-specific alignment guide attachable to a surface of a proximal femoral bone of a patient receiving a prosthetic implant, the guide comprising at least first and second components adjacent to one another, the first component having a first three-dimensional bone engagement surface and the second component having a second three-dimensional bone engagement surface, the first and second bone engagement surfaces configured preoperatively from three-dimensional images of the bone of the patient from imaging scans of the patient to anatomically match corresponding first and second portions of the surface of the bone, and wherein the first component has a head portion configured to engage and anatomically match a corresponding portion of a femoral head of the femoral bone and a first neck portion configured to engage and anatomically match a corresponding portion of a femoral neck of the patient, and wherein the second component has a second neck portion configured to engage and match a remaining portion of the femoral neck of the patient, wherein the first neck and second portions are configured to surround completely the entire femoral neck of the patient;

at least one alignment formation for guiding a drill and formed in the first component and passing perpendicularly through the head portion of the first component; and

a coupling mechanism removably connecting the first and second components to one another such that the patient-specific guide can be positioned to completely surround and contact the entire femoral neck of the patient.

2. The orthopedic apparatus of claim 1, wherein the alignment formation defines a guiding bore.

3. The orthopedic apparatus of claim 1, wherein the coupling mechanism is a snap-fit or interlocking mechanism allowing complete separation of the first and second components.

4. The orthopedic apparatus of claim 1, wherein the coupling mechanism is a hinge allowing relative rotation between the first and second components.

5. An orthopedic apparatus comprising:

a patient-specific femoral alignment guide for a knee joint of a patient including;

a first component having a first three dimensional surface conforming in shape to a first portion of a distal femoral surface from a three-dimensional image of the patient'"'"'s distal femur obtained from preoperative imaging scans of the patient, the first component having an alignment formation referencing a first axis, wherein the first component is configured to engage and anatomically match an osteophyte on the distal femoral surface of the patient; and

a second component removably attached to the first component, the second component having a second three-dimensional surface conforming in shape to a second portion of the distal femoral surface of the patient from the three-dimensional image of the patient'"'"'s distal, the second component having an alignment formation referencing a second axis.

6. The orthopedic apparatus of claim 5, wherein at least one of the first and second components includes an indicator feature associated with a corresponding landmark anatomic feature for guiding placement of the corresponding component.

7. The orthopedic apparatus of claim 6, wherein the indicator feature is a pointing protrusion extending from the corresponding component.

12. The orthopedic apparatus of claim 5, wherein the first and second components are rotatable relative to one another.

13. The orthopedic apparatus of claim 5, wherein the first and second components are interlockable.

8. A manufacturing assemblage for orthopedic surgery comprising:

a first patient-specific alignment guide configured preoperatively from three-dimensional images of a first joint surface of a patient from imaging scans of the patient to anatomically match the first joint surface of the patient;

a second patient-specific alignment guide configured preoperatively from three-dimensional images of a second joint surface of a patient from imaging scans of the patient to anatomically match the second joint surface of the patient; and

a frangible connection arm coupled to the first alignment guide at a first connection end and to the second alignment guide at a second connection end, the connection arm configured to retain and associate the first and second patient-specific alignment guides to one another during delivery for surgical use, the connection arm including frangible features configured to break off the connection arm and separate the first and second patient-specific alignment guides for surgical use.

9. The manufacturing assemblage of claim 8, wherein the connection arm includes a plurality of interconnected links.

10. The manufacturing assemblage of claim 8, wherein the frangible features are located adjacent the first and second connection ends.

11. The manufacturing assemblage of claim 8, wherein the first patient-specific alignment guide is a patient-specific femoral alignment guide and the second patient-specific alignment guide is a patient-specific tibial alignment guide for a knee joint of the patient.