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METHOD FOR DETERMINING THE LOCATION AND ORIENTATION OF A BONE FOR COMPUTER-ASSISTED ORTHOPEDIC PROCEDURES USING INTRAOPERATIVELY
ATTACHED MARKERS 5
CROSS-REFERENCES TO RELATED
The present application is a regular application and claims the benefit of priority from U.S. Provisional Patent Application Ser. No. 60/112,321 filed Dec. 14,1998, the complete disclosure of which is hereby incorporated herein by reference for all purposes.
TECHNICAL FIELD 15
The present invention relates to surgical bone cutting systems and more particularly to systems for detecting or tracking bone motion during surgery.
BACKGROUND OF THE INVENTION
When performing robotically assisted total hip replacement surgery, (for example, when cutting a cavity into a patient's femur bone for the insertion of an artificial hip joint 2J therein), it is very important to minimize the effects of bone motion. Successful hip replacement surgery, particularly when using cementless implants, relies on the highly accurate creation of the cavity within the proximal (upper) end of the femur for receiving the implant. Deviations of less than 3Q plus or minus 1 mm from the planned cavity placement and dimensions are desirable.
Accordingly, to minimize the effects of unwanted bone motion on cutting accuracy, it has been desirable to attempt to prevent bone motion to the maximum degree possible by 35 firmly anchoring the bone while the surgical bone cutter is operating on the bone. Typically, unwanted bone motion has been restrained by the use of fixators which hold the bone in position as firmly as is possible. Unfortunately, there are practical limits as to how securely the bone can be held in 40 position by a fixator. For example, for many surgical procedures it is necessary for the surgical team to hand hold retractors for surgical access. Changes in the forces applied to the bone by these hand held retractors can cause unwanted bone motion. Moreover, in many cases the surgical team 45 does not know whether additional retraction is required until after the bone cutting procedure has commenced. As such, it is typically necessary to modify or slightly change the retraction forces on the bone during the course of the bone surgery. This can have the undesirable effect of causing 50 unwanted bone motion, leading to inaccuracies in cutting the bone. In addition, under some conditions, such as to provide optimal cutting access, it may even be desirable to move the bone slightly during surgery. This further complicates the problem of cutting inaccuracies caused by unwanted bone 55 motion thereafter.
Small amounts of bone motion cause the surgical operative site to "drift", thereby causing undesirable implant cavity placement errors as the bone moves while a robotic bone cutter is cutting the implant cavity in the bone. Larger 60 amounts of bone motion can cause serious cutting inaccuracies and are indicative of the bone fixation or retraction system becoming unstable. Should such larger amounts of bone motion occur, it is then necessary to immediately shut down the cutting operation and restart the cutting procedure 65 after re-locating the position of the bone with respect to the cutting device. Specifically, the surgical team is required to
remove the cutting device and its accompanying gas supply hose and irrigation, re-determine the position of the bone with respect to the cutting device, and then reinstall the cutter, gas supply, and irrigation systems before continuing with the bone cutting procedure. This can be very time consuming and frustrating for the surgical team.
SUMMARY OF THE INVENTION
As discussed above, unwanted bone motion can generate cutting inaccuracies during bone surgery. Such unwanted bone motion cannot be completely eliminated during bone surgery. Accordingly, the present invention provides a system to minimize the effects of unwanted bone motion by tracking the motion of the bone such that the unwanted bone motion can be compensated for during surgery on the bone.
The present invention provides a method for re-registration between a robotic coordinate system and an image data set, comprising: providing an image data set that has been registered within the robotic coordinate system based upon an initial bone position within the robotic coordinate system; locating at least three conserved points fixed relative to the initial bone position prior to a detectable change in bone position from the initial bone position; relocating the same at least three conserved points after bone motion may have occurred thereby determining changes in the position of the three conserve points; and re-registering the image data set within the robotic coordinate system based on the changes in position of the three conserved points.
In the present invention, intraoperatively attached fiducial markers are used to determine the position and orientation of the bone and to track bone motion over time. The intraoperatively attached fiducial markers are used to define at least three conserved points which are fixed relative to the bone. Bone motion is tracked over time by tracking the motion of the at least three conserved points over time.
In the present invention, the at least three conserved points (which are fixed relative to the bone), are located and tracked within the coordinate system of the surgical robotic arm subsequent to initially registering an image data set of the bone to the surgical robotic arm.
In one preferred aspect of the invention, the three conserved points are defined by two implanted fiducial markers. Preferably, at least one fiducial is implanted after the image data set of the bone, (which represents the shape of the bone), has been created.
First, the surgical robotic arm is registered to the bone. Initially registering the surgical robotic arm to the bone comprises determining the initial spatial relationship between the surgical robotic arm and the bone, (wherein the shape of the surface of the bone is preferably represented by an image data set).
The registration of the surgical robotic arm to the image data set of the bone can be accomplished using a variety of techniques. In certain aspects of the present invention, a variety of techniques using radio-opaque marker pins can be used.
For example, as is described in provisionally filed Patent Application entitled Bone Motion Tracking System, U.S. patent application Ser. No. 60/112,319 filed Dec. 14, 1998, and in non-provisionally filed U.S. patent application Ser. No. 09/247,818 filed on Feb. 9,1999, incorporated herein by reference in their entirety for all purposes, marker pins are attached to the bone prior to surgery and a pre-surgical image of the bone with the marker pins attached is taken. The pre-surgical image can preferably be generated by
computerized tomography (CT), digital radiography, or the like. From the image data set representing the pre-surgical image of the bone, the spatial relationship of the bone with respect to the marker pins can be determined, (ie: the position and orientation of the bone can be determined by 5 knowing the position and orientation of the marker pins). In one aspect, the surgical robotic arm is registered to the bone by being moved to contact each of the marker pins in turn. As such, the position of each of the marker pins will be sequentially recorded in terms of the surgical robotic arm's 10 co-ordinate system, thereby registering the surgical robotic arm to the bone. In other aspects, a digitizer arm, (which may comprise an articulated passive mechanical arm), is registered to the bone by being moved to contact each of the marker pins in turn. In this aspect, the digitizer arm is first 15 registered to the robotic arm's coordinate system.
Alternatively, the present surgical robotic arm can be registered to the bone using marker pins by the system described in co-pending application Ser. No. 09/022,643, filed Feb. 12,1998 now abandoned, and incorporated herein 20 by reference in its entirety for all purposes, which describes a method and system for transforming a bone image into a robotic coordinate system based upon registering between the robotic coordinate system and the image data set: (1) two positional coordinates axially spaced apart along the bone 25 and (2) a directional vector passing through at least one of the positional coordinates.
In alternate approaches, the present surgical robotic arm can be initially registered to the bone without the use of fiducial marker pins. For example, the initial position and 30 orientation of the bone may be determined by an imaging system which relies upon sensing anatomical features of the bone. Such an imaging system may comprise an optical or ultrasound system which views the shape and location of the bone. 35
Alternatively, the surgical robotic arm can be registered to the bone without the use of fiducial marker pins by the system described in U.S. Pat. No. 5,806,518, incorporated herein by reference in its entirety for all purposes, in which 4Q a bone image is transformed into a robotic coordinate system by aligning a robotic probe within the medullary canal of the femur.
Alternatively, the surgical robotic arm can be registered to the bone without the use of fiducial marker pins by the 45 system described in U.S. Pat. No. 6,033,415, incorporated herein by reference in its entirety for all purposes, which describes a method and system for transforming a bone image data set representing a bone image into a robotic coordinate system by registering a bone digitizer arm to the 50 robotic coordinate system, generating a digitized bone data set by taking bone surface position measurements with the digitizer arm, and transforming the bone image data set into the robotic coordinate system by performing a best fit calculation between coordinates of the bone image data set 55 and corresponding coordinates of the digitized bone data set.
Subsequent to registration of the surgical robotic arm to the bone, (using any of the techniques described above or any other technique), the locations of at least three conserved fiducial points fixed relative to the bone are then go determined. Preferably, the three conserved points are fixed relative to the bone intraoperatively, and may be affixed to the bone subsequent to the initial registration of the surgical robotic arm to the bone.
The at least three conserved points are used to define a 65 marker coordinate system to track the movement of the bone. Specifically, by tracking movement of the three con
served points, the corresponding movement of the bone can be determined.
An advantage of the present system of tracking bone movement by tracking movement of the three conserved points affixed to the bone is that a large degree of bone movement is possible without tracking being lost. In addition, it is possible to move the bone through a large degree of bone movement without mechanical tracking devices attached to the bone limiting the range of available bone movement.
The ability to achieve a large degree of bone movement during surgery may be advantageous for a number of reasons. For example, when performing computer assisted total knee replacement procedures, it is desirable to install a trail component and then take the knee through a set of motions. These motions generally require moving the limb over a large range of angles. These extensive movements make it very difficult to track both the femur and tibia when using bone tracking devices attached to the bone.
Another advantage of the present invention is that, by relying on a set of conserved points (located, tracked and preferably fixed relative to the bone after registration of the surgical robotic arm to the bone), the bone can be rapidly relocated without relying upon an anatomical features which may have been removed during the operative procedure.
By using three conserved marker points affixed relative to the bone during surgery, bone motion can be tracked regardless of changes to the features of the bone which may occur during surgery. This allows for refining cuts to be made in relation to previously cut surfaces, without relying on a preoperative fiducial marker system which may have been used to initially register the surgical robotic arm to the bone.
Additionally, by only tracking movement of the three conserved points subsequent to initial registration, (as opposed to tracking movements of a plurality of marker pins which may have been attached to the bone to initially register the surgical arm to the bone), any error components associated with the initial registration are not present in the tracking of the three conserved points.
Moreover, tracking movement of the present three conserved points can be performed much easier and faster than tracking bone movement by tracking a much larger number of surface location points on the bone, (wherein the surface location points define anatomical features of the bone).
The present invention is particularly advantageous for use with trauma cases or in reconstructive osteotomies where it is important to determine the position and orientation of multiple bone fragments and then track how they move. In such applications, features could be added to the fixture system defining the three conserved points such that it could be identified in fluoroscopy images after they are connected to the bone. In such applications, the fixture could be referenced in the images and then desired actions could be defined relative to the fixture coordinates.
In a preferred aspect, the present invention uses an articulated passive mechanical digitizing arm to identify the locations of the three conserved points, thereby generating a conserved point data set, (comprising coordinates representing the position of the conserved points which are affixed to the bone). The mechanical digitizing arm is preferably pre-registered to the robot coordinate system such that the positions of the three conserved points are determined in the robotic coordinate system. Alternatively, the locations of the conserved points may be determined by the surgical robotic arm itself.
The proximal end of the digitizer arm is preferably secured at a fixed location in the coordinate system of the