Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2001-09-17
2004-04-20
Bruce, David V. (Department: 2882)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S407000, C600S424000, C600S426000, C600S438000, C606S130000
Reexamination Certificate
active
06725082
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method and system for computerized in-situ planning and guidance of ligament graft placement.
BACKGROUND OF THE INVENTION
Treatment of injuries and other conditions associated with a joint of an individual often involves the re-attachment or reconstruction of one or more ligaments. For example, anterior cruciate ligament (ACL) rupture is a very common sports-related injury. Ligament reconstruction with autogenous graft using a minimally invasive endoscopic approach has become a standard therapy in ACL replacement. Endoscopic surgical approaches seek to minimize trauma to the individual.
Unfortunately, approximately 40% of ACL ligaments are improperly located, e.g., misplaced as a result of reconstructions performed by traditional endoscopy. Such improper ligament placement can lead to premature degeneration of knee structures, which degeneration can eventually necessitate total knee joint replacement. To facilitate proper ligament placement, a practitioner is preferably able to identify and locate anatomical landmarks associated with the joint. For example, proper ligament reconstruction or positioning involves steps such as the drilling of tunnels that are properly placed with respect to the anatomical landmarks, avoiding the impingement of ligaments and surrounding tissues, ensuring that ligament elongation does not exceed 10% (collagen fibre ruptures beyond 10% elongation), selecting proper graft tension and position to restore knee stability; and obtaining proper graft fixation in good quality bone.
A portion of ligament misplacements are attributable to the restricted, local endoscopic view, which fails to provide surgeons with a global overview of ligament position, such as that seen in traditional postoperative X-rays. For example, the endoscopic view limits a surgeon's ability to identify landmarks, which would otherwise assist in proper ligament placement.
A method for determining the femoral point of graft attachment during ACL replacement is disclosed in European Patent Application No. 0603089 to Cinquin et al. The disclosed method concerns the determination of a femoral point of graft attachment with respect to a tibial graft attachment point such that the distance between these two points remains invariant during knee flexion and extension. The positions within an on-site three-dimensional coordinate system of a reference and a pointer, which are both provided with energy emitting markers, are determined by means of a three-dimensional position measurement system, such as the OPTOTRAK position measurement system, Northern Digital, Waterloo, On. The position measurement system measures the position of the markers with respect to the on-site three-dimensional coordinate system. Therewith, the position of the tip of the pointer is determinable by means of a computer.
The Cinquin method comprises the steps of (1) attachment of a first reference at the tibia; (2) positioning of the pointer tip at a previously determined point T
1
and measuring the position of the pointer tip with respect to the first reference; (3) Positioning of the pointer tip at several points P
1
at the trochlea of the femur close to that position where the invariant point is expected; (4) Calculation of the distances of point T
1
and each of the points P
1
; (5) Displacement of the femur with respect to the tibia and calculation of the variations of the distances between T
1
and each of the points P
1
; (6) Selection of that point P
1
among points P
1
which shows the most invariant distance.
The Cinquin method measures knee movement to obtain a “functional” placement of the ligament that respects certain elongation criteria. The disadvantage of this method is that anatomical placement criteria such as a general overview of graft position with respect to the whole anatomy of the joint are not obtained.
BRIEF SUMMARY OF THE INVENTION
The present invention is related to a ligament replacement system, which allows both consideration of functional and anatomical criteria in a variety of graft types, surgical philosophies and surgical techniques. The system preferably provides realtime computerized in-situ planning and guidance of ligament graft placement. Most preferably, the system provides planning and guidance for anterior cruciate ligament insertion.
One embodiment of the system comprises a position measurement device in communication with a computer to determine the position and orientation of objects in a three dimensional coordinate system. The three dimensional coordinate system includes at least one organ, such as a femur or tibia, of an individual. Objects to be tracked comprise at least three markers, which can be configured to emit, receive, or reflect energy, such as light or acoustic energy. For example, energy emitters can include light sources, such as light emitting diodes emitting in the visible or infrared, acoustic transmitters, or conductive coils suitable for establishing a detectable magnetic field. Energy receiving means include light detectors, such as photodiodes or charge coupled devices. Microphones or Hall-effect elements may also be used.
To sense the position of energy emitting markers, the system includes at least three energy detecting elements, such as three light detectors. The three energy detecting elements cooperate with the energy emitting markers to determine the position of each marker associated with an object to be tracked. Based on the respective positions of markers associated with the tracked object, the position and orientation of the tracked object are determined.
The system preferably includes a plurality of reference bodies, which can be used to determine the position and orientation of an organ of an individual. The reference bodies are preferably rigid, having at least three markers each. Each reference body preferably comprises an attachment element, such as a screw or pin, with which the reference bodies can be attached to an organ, such as a bone. For example, respective reference bodies can be attached to the femur and tibia. In one embodiment, the reference markers are fiducial markers.
The system also includes a pointer and an endoscope. The pointer includes markers, which allow the position and orientation of the pointer to be determined. The pointer includes a pointer tip having a known spatial relationship to the markers. Thus, the position of the pointer tip can be determined from the positions of the markers. The endoscope preferably includes markers that allow the position and orientation of the endoscope to be determined in the three dimensional coordinate system. In a preferred embodiment, the pointer and endoscope are integral with one another.
The computer is configured to determine the position and orientation of the reference bodies, endoscope, and pointer based upon the position and orientation of the associated markers. The pointer and the endoscope are preferably configured as a one-piece computer-integrated endoscopic instrument.
An embodiment of the system includes a medical imaging device, which preferably includes an X-ray source and an X-ray receiver, for gathering medical image data, which is transferred to the computer either directly in numerical format or upon digitizing a radiographic film of the image. The computer is configured to process the image such as by magnifying a portion of the image. The imaging device can be used preoperatively and/or intraoperatively.
In a preferred embodiment, the system includes an ultrasound device, having associated markers, which allow the position and orientation of an ultrasound head of the ultrasound device to be determined as discussed above. The ultrasound device is in communication with the computer, which can process and display ultrasound data acquired by the ultrasound device. In a preferred embodiment the ultrasound device is an A-mode ultrasound device configured to emit and receive an ultrasound beam along a preferably known axis to allow realtime signal processing and or display of ultrasound data.
The c
Nolte Peter Lutz
Sati Marwan
Bruce David V.
Ho Allen C.
Jones Day
Synthes (U.S.A.)
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