Force sensing apparatus and method for orthopaedic joint reconstruction

• US 5,470,354 A
• Filed: 08/10/1994
• Issued: 11/28/1995
• Est. Priority Date: 11/12/1991
• Status: Expired due to Term

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Booth, Robert E. Jr., Hershberger, Troy W.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/288,545
• Time in Patent Office: 475 Days
• Field of Search: 623/16-23, 606/86-88, 606/91, 606/102, 128/782
• US Class Current: 128/898
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 5/224 Measuring muscular strength
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/3877 Patellae or trochleae
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/461 of knees
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/468 Testing instruments for artificial joints for testing non-implantable prostheses A61F2/76
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30736 Augments or augmentation pieces, e.g. wedges or blocks for bridging a bone defect
• CPC Class Codes: A61F 2002/4666 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: Y10S 623/914 Bone

Abstract

Methods and devices for assessing and determining proper alignment and placement of implant components during joint reconstruction surgery, particularly in the knee joint. Provisional components with force transducers 150, 240 are positioned in the joint 40 and used to determine the precise forces and decide how to balance the forces in the joint. In the knee joint, a provisional tibial component 80 and a provisional patella component 85 are used. The tibial component has a base member 84 and a pair of bearing elements 88, 90 held loosely in place by a clamping frame 86. Rocker members 130, 132 allow the bearing elements to move or rock relative to the base member. The patella component has a base plate 220 and a bearing element 222 held loosely in place by a plurality of pins 228. A rocker member 232 allows the bearing element to move or rock relative to the base plate. Force transducers or sensors 150, 240 connected to computers are positioned in the provisional components 80, 85 and provide readings of the location and magnitude of the sum of the forces generated in the joint when the joint is moved through its range of motion.

Claims

1. A method of determining the forces acting on a provisional component used in knee joint reconstructive surgery, comprising:

installing a femoral component in a prepared knee joint to be reconstructed, said femoral component having a pair of condyle portions cooperating with a resected end of a femur and forming an articulating surface;

temporarily installing a provisional tibial component in the prepared knee joint, said provisional tibial component including a tibial member cooperating with a resected end of a tibia, and a pair of bearing elements in load bearing alignment between said tibial member and said condyle portions, said bearing elements having a pair of bearing surfaces interacting with the articulating surface, and a pair of opposite rocker surfaces,

positioning a tibial force transducer between said tibial member and said pair of rocker surfaces to measure the load exerted therebetween;

flexing the knee joint through a range of motion;

monitoring the load exerted on the tibial force transducer while the joint is flexed; and

adjusting the knee joint as required to achieve proper alignment and positioning of the final knee implant.

2. The method of claim 1 wherein the tibial force transducer used in the positioning step is provided with an array of load cells and said monitoring step further comprises measuring the location and magnitude of the force exerted by each of said pair of rocker surfaces on said tibial member.

3. The method of claim 2, said method further comprising:

temporarily installing a provisional patella component in the knee joint, said patella component including a patella member cooperating with a resected surface of the patella;

positioning a patella force transducer between said patella member and said resected patella surface to measure the load exerted therebetween; and

monitoring the load exerted on the patella force transducer while the joint is flexed.

4. The method of claim 3 wherein the patella force transducer used in the positioning step is provided with an array of load cells and said monitoring step further comprises measuring the location and magnitude of the force exerted by said patella member on said resected patella surface.

5. The method of claim 1 wherein said step of positioning a tibial force transducer between said tibial member and said pair of rocker surfaces includes provisionally retaining said force transducer by means of a clamping member.

6. The method for accessing and determining proper alignment and placement of permanent implant components during joint reconstruction, comprising the steps of:

(1) affixing a first permanent implant prototype on one side of a joint;

(2) preparing a plateau on another side of the joint for receiving a second permanent implant;

(3) provisionally affixing a base to the plateau and interposing a bearing element between the first permanent implant prototype and the base such that the bearing element is rockable relative to the base in response to manipulation of the joint;

(4) provisionally interposing a force sensor between the base and the bearing element adapted to generate force signals when the bearing element rocks relative to the base;

(5) manipulating said joint through a desired range of flexion to cause the bearing element to rock relative to the base and generate a pattern of force magnitude and location signals indicative of joint alignment and contact areas;

(6) making adjustments to the joint as necessary to balance the forces and assure proper alignment and positioning of the permanent implants in view of the pattern of force signals;

(7) removing the base, bearing element and force sensor from the plateau;

(8) substituting a first permanent implant for its prototype; and

(9) placing the second permanent implant on the plateau.

7. The method of claim 6 wherein the joint is a knee having a patella, the first permanent implant prototype is a femoral implant and the second permanent implant is a tibial implant.

8. The method of claim 7 including the further step of preparing another plateau on the patella and wherein steps (3), (4), (5), (6), (7) and (8) are performed with respect to both plateaus and step (9) includes placing the second permanent implant on one of the plateaus.

9. The method of claim 8 wherein step (5) is performed simultaneously with both bearing elements.

10. The method for assessing and determining proper alignment and placement of permanent implant components during joint reconstruction, comprising the steps of:

(1) affixing a first implant on one side of a joint;

(2) preparing a plateau on another side of the joint for receiving a second permanent implant;

(3) provisionally affixing a base to the plateau and interposing a bearing element between the first implant and the base such that the bearing element is rockable relative to the base in response to manipulation of the joint;

(4) provisionally interposing a force sensor between the base and the bearing element adapted to generate force signals when the bearing element rocks relative to the base;

(5) manipulating said joint through a desired range of flexion to cause the bearing element to rock relative to the base and generate a pattern of force magnitude and location signals indicative of joint alignment and contact areas;

(6) making adjustments to the joint as necessary to balance the forces and assure proper alignment and positioning of the implants in view of the pattern of force signals;

(7) removing the base, bearing element and force sensor from the plateau; and

(8) placing the second permanent implant on the plateau.

11. The method of claim 10 wherein the joint is a knee having a patella, the first implant is a femoral implant and the second permanent implant is a tibial implant.

12. The method of claim 11 including the further step of preparing another plateau on the patella and wherein steps (3), (4), (5), (6) and (7) are performed with respect to both plateaus and step (8) includes placing the second permanent implant on one of the plateaus.

13. The method of claim 10 wherein said step of provisionally interposing a force sensor between the base and the bearing element includes retaining said force sensor by means of a clamping member.