METHOD AND SYSTEM FOR DESIGNING PATIENT-SPECIFIC ORTHOPAEDIC SURGICAL INSTRUMENTS

• US 20090088674A1
• Filed: 09/30/2007
• Published: 04/02/2009
• Est. Priority Date: 09/30/2007
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Inventors: Caillouette, James, Sherman, Jason T., Guzman, Jose F.
• Granted Patent: US 8,357,111 B2
• Time in Patent Office: Days
• US Class Current: 602/26
• CPC Class Codes: A61B 17/154 for preparing bone for knee prosthesis
• CPC Class Codes: A61B 17/8863 Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2090/067 for measuring angles
• 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 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/1071 measuring angles, e.g. using goniometers A61B5/1123 takes precedence
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4533 Ligaments
• CPC Class Codes: A61B 5/6806 Gloves
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 6/03 Computed tomography [CT] echo-tomography A61B8/14
• CPC Class Codes: A61B 6/56 Details of data transmission or power supply, e.g. use of slip rings
• CPC Class Codes: A61B 6/563 involving image data transmission via a network

Abstract

A method and system for designing a patient-specific orthopaedic surgical instrument includes coupling a knee sleeve to a leg of the patient. The knee sleeve includes sensors configured to generate sensor data indicate of the position of the respective sensor. The method also include determining angulation data indicative of the angulation of the knee based on the sensor data. The angulation data may be indicative of, for example, the ligament laxity of the knee. The method may also include generating a medical image(s) of the knee. The design of the patient-specific orthopaedic surgical instrument is determined based on the angulation data and the medical image(s).

Claims

1. A method for designing a patient-specific orthopaedic surgical instrument to be used on a knee of a patient, the method comprising:

coupling a knee sleeve to a leg of the patient, the knee sleeve including (i) a first sensor coupled to a superior half of the knee sleeve and generating first data indicative of the position of the first sensor and (ii) a second sensor coupled to an inferior half of the knee sleeve and generating second data indicative of the position of the second sensor;

determining angulation data based on the first data indicative of the angulation of the knee of the patient based on the first data and the second data;

generating a medical image of the knee of the patient; and

determining a design of a patient-specific orthopaedic surgical instrument based on the medical image and the angulation data.

2. The method of claim 1, wherein determining the angulation data comprises determining data indicative of the ligament laxity of the knee.

3. The method of claim 1, wherein determining the angulation data comprises:

(i) determining valgus data indicative of an amount of valgus angulation of the leg of the patient, and

(ii) determining varus data indicative of an amount of varus angulation of the leg of the patient.

4. The method of claim 3, wherein:

determining valgus data comprises determining valgus data indicative of the amount of valgus angulation of the leg of the patient with respect to a first amount of force applied to the leg at a first location on the leg, and

determining varus data comprises determining varus data indicative of the amount of varus angulation of the leg of the patient with respect to a second amount of force applied to the leg at a second location on the leg.

5. The method of claim 1, wherein determining the angulation data comprises determining the position of the femur of the leg of the patient based on the first data and determining the position of the tibia of the leg of the patient based on the second data.

6. The method of claim 1, wherein determining the angulation data comprises:

applying an amount of force to the leg of the patient at a location on the leg to position the leg of the patient in a valgus position;

generating angle data indicative of the valgus angulation of the leg when in the valgus position;

generating force data indicative of the amount of force; and

generating location data indicative of the location on the leg at which the force is applied relative to a predetermined location.

7. The method of claim 1, wherein determining the angulation data comprises:

applying an amount of force to the leg of the patient at a location on the leg to position the leg of the patient in a varus position;

generating angle data indicative of the varus angulation of the leg when in the varus position;

generating force data indicative of the amount of force; and

generating location data indicative of the location on the leg at which the force is applied relative to a predetermined location.

8. The method of claim 1, wherein determining angulation data comprises determining the position of the femur of the leg of the patient based on the first data and determining the position of the tibia of the leg of the patient based on the second data while the patient is in a standing position.

9. The method of claim 1, wherein determining angulation data comprises determining the position of the femur of the leg of the patient based on the first data and determining the position of the tibia of the leg of the patient based on the second data while the patient is in motion.

10. The method of claim 1, further comprising determining constraint data indicative of preferences of an orthopaedic surgeon, wherein determining a design of a patient-specific orthopaedic surgical instrument comprises determining a design of a patient-specific orthopaedic surgical instrument based on the medical image, the angulation, and the constraint data.

11. The method of claim 1, wherein determining a design of a patient-specific orthopaedic surgical instrument comprises determining a design of a patient-specific orthopaedic surgical instrument including a bone-contacting surface having a negative contour matched to the contour of a portion of the patient'"'"'s bone.

12. The method of claim 1, wherein determining a design of a patient-specific orthopaedic surgical instrument comprises adjusting the location of a cutting guide of a bone cutting block based on the angulation data.

13. A system for designing a patient-specific orthopaedic surgical instrument to be used on a knee of a patient, the system comprising:

a knee sleeve configured to be coupled to a leg of the patient;

a first sensor coupled to the knee sleeve and configured to generate first data indicative of the position of the first sensor;

a second sensor coupled to the knee sleeve and configured to generate second data indicative of the position of the second sensor;

a force sensor configured to generate force data indicative of an amount of force applied to the leg of the patient; and

a first computer configured to (i) determine angle data indicative of the degree of angulation between the femur and the tibia of the patient'"'"'s leg based on the first data and the second data, (ii) determine location data indicative of the location of the force sensor relative to a predetermined location, and (iii) store the angle data, force data, and location data.

14. The system of claim 13, wherein the force sensor is incorporated into a glove.

15. The system of claim 13, wherein the force sensor is coupled to the knee sleeve.

16. The system of claim 14, wherein the first computer is configured to (i) determine third data indicative of the position of the femur of the leg of the patient based on the first data and (ii) determine fourth data indicative of the position of the tibia of the leg of the patient.

17. The system of claim 13, further comprising a second computer remote from the first computer, the second computer configured to generate a three-dimensional model of the patient-specific surgical instrument based on the angle data, force data, and location data.

18. A method for designing a patient-specific orthopaedic surgical instrument, the method comprising:

coupling a knee sleeve to a leg of the patient, the knee sleeve including (i) a first sensor coupled to a superior half of the knee sleeve and generating first data indicative of the position of the first sensor and (ii) a second sensor coupled to an inferior half of the knee sleeve and generating second data indicative of the position of the second sensor;

generating laxity data indicative of the ligament laxity of the knee of the patient based on the first and second data; and

generating a design of a patient-specific orthopaedic instrument based on the laxity data.

19. The method of claim 18, further comprising generating a medical image of the patient'"'"'s knee, wherein generating a design of the patient-specific orthopaedic instrument comprises generating a design of the patient-specific orthopaedic instrument based on the laxity data and the medical image.

20. The method of claim 18, wherein generating laxity data comprises:

applying a first amount of force to the leg at a first location on the leg to position the leg of the patient in a valgus position,

generating first angle data indicative of the valgus angulation of the leg when in the valgus position,

generating first force data indicative of the first amount of force,

generating first location data indicative of the first location relative to a predetermined location,

applying a second amount of force to the leg at a second location on the leg to position the leg of the patient in a varus position,

generating second angle data indicative of the varus angulation of the leg when in the varus position,

generating second force data indicative of the second amount of force, and

generating second location data indicative of the second location relative to the predetermined location,

wherein generating a design of the patient-specific orthopaedic instrument comprises generating a design of the patient-specific orthopaedic instrument based on the first angle data, the first force data, the first location data, the second angle data, the second force data, and the second location data.