Not Applicable.
Not Applicable.
1. Field of the Invention
This invention relates generally to computer assisted surgery and more particularly to a system for computer assisted surgery utilizing a projected method for determining tibial rotation.
2. Related Art
During knee arthroplasty, one or more of the distal surfaces of the femur are cut away and replaced with a metal component to simulate the bearing surfaces of the femur. Similarly, one or more of the proximal surfaces of the tibia is modified to provide a metal-backed plastic bearing surface. The metal femoral component of the new prosthetic joint transfers the weight of the patient to the tibial component such that the joint can support the patient's weight and provide a near-normal motion of the knee joint.
Orthopedic surgeons have been struggling with the alignment of knee arthroplasties since their inception in the early 1970s. Basically, what is generally necessary is a 5-7 degree angular resection of the distal femoral condyles as related to the mechanical axis of the femur and a perpendicular resection of the proximal tibia as related to its central axis. Early on, resections of the distal femur and proximal tibia were made by visually trying to match or correct the existing anatomy by eye. Alignment varied considerably depending on the skill of the operating surgeon.
Several studies have indicated that the long term performance of a prosthetic knee joint is dependant on how accurately the components of the knee joint are implanted with respect to the weight bearing axis of the patient's leg. The most important parameter in achieving long term performance is accurate alignment of the components. It has been proven that only 4.5 degrees of misalignment causes the components to only load one side of the knee joint leading to rapid failure of the implant. The literature strongly supports the conclusion that the closer the surgeons approach neutral alignment, the more successful the implant system will be with longevity. Misaligned knee arthroplasties tend to get worse with time because the abnormal weight distribution accelerates the wear on the overloaded side leading to rapid failure within a few years in the case of the gross malalignment.
In a correctly functioning knee, the weight bearing axis passes through the center of the head of the femur, the center of the knee and the center of the ankle joint. This weight bearing axis typically is located by analyzing an X-ray image of the patient's leg, taken while the patient is standing. The X-ray image is used to locate the center of the head of the femur and to calculate the position of the head relative to selected landmarks on the femur. The selected landmarks are then found on the patient's femur during surgery and the calculations used to estimate the actual position of the femoral head. These two pieces of information are used to determine the correct alignment of the weight bearing axis for the femur, commonly referred to as the mechanical axis of the femur. To completely define the correct position for the femoral component of the knee prosthesis, the correct relationship between the center of the femoral head and the knee joint and the rotation of the knee joint about the mechanical axis must be established. This information is determined from landmarks on the distal portion of the femur. The correct alignment for the tibial component of the knee prosthesis ordinarily is determined by finding the center of the ankle joint and relating its position to landmarks on the tibia. This point and the center of the proximal tibial plateau are used to define the weight bearing axis, or mechanical axis, of the tibia. The correct relationship between the ankle joint and the knee joint and the rotation of the knee joint about the mechanical axis are determined by reference to the distal portion of the femur and landmarks on the tibial plateau.
Presently, doctors commonly determine a desired rotation of the tibia simply by placing the knee in full extension and looking at the alignment of the foot. This method has several deficiencies. First, any errors that are developed in the determination of the femur's rotational axis are projected onto the tibia. Second, this method is much more susceptible to anatomic abnormalities and joint instability, which is common in patients requiring total knee arthroplasty. Third, a good rotational assessment of the tibia itself is not accurately determined, but rather, the entire rotation of the limb is being assessed in aggregate, without specific knowledge of the rotation of the tibia itself or the tibial component.
Other methods currently used to determine the Anterior-Posterior (AP) axis of the tibia rely on anatomic landmarks. One common method uses a line drawn from the medial ⅓ of the tibial tubercle to the center of the tibial plateau. Another method uses a line drawn from the anterior cruciate ligament insertion to the posterior cruciate ligament insertion. Still another method considers the average of these two or lines drawn from other landmarks, which assumes that averaging of these methods adds credence to the result. Ultimately though, because these points are all very close to each other in space, these methods are greatly affected by very small changes in their perceived location and thus are poorly reproduceable.
In yet another method, the rotation of both the femur and tibia is determined by developing a kinematic axis in the knee joint. This method requires the limbs to be moved with respect to each other, during which software determines the axis about which the tibia rotates with respect to the femur. Software then uses this axis for measuring rotation around the mechanical axis of the tibia and femur. The problem with this method is that it is extremely sensitive to anatomic abnormalities, as well as ligament instability.
For some time, computer assisted surgery (also known as “image-guided surgery,” “surgical navigation,” or “3-D computer surgery”) has been applied to invasive surgical procedures, such as knee arthroplasty. Computer assisted surgery, often abbreviated CAS, typically includes systems and processes for tracking anatomy, implements, instrumentation, trial implants, implant components and virtual constructs or references, and rendering images and data related to them in connection with orthopedic, surgical and other operations. CAS allows for the association of anatomical structures, constructs, and points-in-space with a fiducial. Fiducial functionality allows the CAS system to sense and track the position and orientation of these items. Such structures, items and constructs can be rendered onscreen properly positioned and oriented relative to each other using associated image files, data files, image input, and other sensory input based on the tracking. The CAS system, among other things, allow surgeons to navigate and perform knee arthroplasty using images that reveal interior portions of the body combined with computer generated or transmitted images that show surgical implements, instruments, trials, implants, and/or other devices located and oriented properly relative to the body part. By using the CAS system, the surgeon can accurately and effectively resection bones, place and assess trial implants and joint performance, and place and assess actual implants and joint performance.
There remains a need in the art for computer assisted surgery system that enables surgeons to accurately and reliably perform knee arthroplasty. In particular, there remains a need in the art for a computer assisted surgery system that allows a user to identify an angular rotation of an item, such as a tool, relative to the mechanical axis of a tibia.
It is in view of the above problems that the present invention was developed. The invention is a system and method for determining tibial rotation. The invention has several advantages over prior devices and techniques. First, the invention has improved accuracy over the art. The invention utilizes the mechanical axis of the femur and the mechanical axis of the tibia to construct a reference plane. Because the endpoints of each axis are not in proximity to each other, small errors in their respective identification do not greatly affect the determination of the reference plane. Moreover, anatomic defects are less likely to effect the rotational position of the tibia. Second, the simplicity of the invention allows it to be easily repeatable. Surgeons are intimately familiar with finding the mechanical axis of the femur and the tibia and significant effort is not required to put the axes in 90 degrees of flexion. The simple and straightforward character of the invention allows it to be carried out by both new and experienced users.
Thus, in furtherance of the above goals and advantages, the present invention is, briefly, a system for performing computer assisted surgery. The system comprises: a first fiducial operatively connected to a first part; a second fiducial operatively connected to a second part; at least one position and orientation sensor adapted to track said first fiducial and said second fiducial; a computer having a memory, a processor, and an input/output device, said input/output device adapted to receive data from said at least one position and orientation sensor relating to a position and an orientation of said first fiducial and said second fiducial, said processor adapted to process said data to identify a first axis of the first part and a second axis of the second part, and said processor adapted to construct a reference plane through said second axis and orthogonal to said first axis; and a monitor operatively connected to said input/output device of said computer, and wherein said monitor is adapted to display a rendering of said reference plane.
Further features, aspects, and advantages of the present invention, as well as the structure and operation of various embodiments of the present invention, are described in detail below with reference to the accompanying drawings.
The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the present invention and together with the description, serve to explain the principles of the invention. In the drawings:
Various positional terms referring to the human anatomy—such as distal, proximal, medial, lateral, anterior and posterior—are used in this application in their customary and usual manner. The term “distal” refers to the area away from the point of attachment to the body, whereas the term “proximal” refers to the area near the point of attachment the body. The term “medial” refers to something situated closer to the middle of the body, while “lateral” refers to something situated closer to the left side or the right side of the body. Finally, “anterior” refers to something situated closer to the front of the body and “posterior” refers to something situated closer to the rear of the body.
Also, the term “mechanical axis” of the femur refers to an imaginary line drawn from the center of the femoral head to the center of the distal femur at the knee, and the term “anatomic axis” of the femur refers to an imaginary line drawn the middle of the femoral shaft. The angle between the mechanical axis and the anatomic axis is generally about six degrees.
In the embodiment shown in
Item 22, such as trial components and prosthetic devices, instrument 23, or other devices used in a surgical procedure may be tracked in position and orientation by the sensor 16. For example, item 22 and instrument 23 may be tracked relative to tibia 10 and femur 12 using fiducials 14. As another example, item 22 and instrument 23 may be tracked relative to a global coordinate system.
Computing functionality 18 can process and store various forms of data. Further, computing functionality 18 can output data on touch-screen or monitor 24. As an example, the data may correspond in whole or in part to body parts or components, such as tibia 10, femur 12, or item 22. For example, in the embodiment shown in
In some embodiments, the system 100 may include a designator or probe 26. The probe 26 may be used in conjunction with the computer functionality 18 to track any point in a field 17 of the position/orientation sensor 16. One of the fiducials 14 is attached to probe 26 for tracking purposes. The surgeon, nurse, or other user touches the tip of probe 26 to a point such as a landmark on bone structure and actuates the foot pedal 20 or otherwise instructs the computer 18 to note the landmark position. The position/orientation sensor 16 “sees” the position and orientation of fiducial 14, “knows” where the tip of probe 26 is relative to that fiducial 14, and calculates and stores the point or other position designated by probe 26 when the foot pedal 20 is hit or other command is given to the computer 18. The computer 18 can also display on monitor 24 the identified point whenever desired and in whatever form or fashion or color. Thus, probe 26 can be used to designate landmarks on bone structure in order to allow the computer 18 to store and track, relative to movement of the fiducial 14, virtual or logical information, such as mechanical axis 28 of the femur 12, medial/lateral axis 30 and anterior/posterior axis 32 of femur 12, tibia 10 and other body parts in addition to any other virtual or actual construct or reference.
Similarly, the mechanical axis and other axes or constructs of body parts 10 and 12 can also be “registered” for tracking by the system 100. As an optional step, the system 100 may employ a fluoroscope to obtain images of the femoral head, knee and ankle of the sort shown in
Alternatively, the surgeon or other person uses the probe 26 to select any desired anatomical landmarks or references to register body parts and related constructs. These points are registered in three dimensional space by the system 100 and are tracked relative to the fiducials 14 on the patient anatomy which are preferably placed intraoperatively.
Other methods may be used to identify the hip joint center 52. For example, The femoral head may be located using various scanning techniques, such as computed tomography (CT) or magnetic resonance imaging (MRI). Further, the hip joint center 52 may be located through laser triangulation. The laser method is similar to measuring the vectorial displacement. A laser is mounted on the distal end of the femur, and the femur is rotated in the acetabulum or a prosthesis to capture a number of samples of position and orientation information. The laser light indicates the center of rotation on a target, which is used by the laser operator to identify the center of the femoral head.
Further, by measuring the vectorial displacement between successive positions of tibial registration point 62 in a reference frame in which femoral registration point 60 remains stationary as tibia 10 is moved, the locus of positions of knee joint center 64 in that reference frame can be calculated.
By identifying the vectorial displacements, the hip joint center 52, and the ankle joint center 54, computing functionality 18 can “learn” and “memorize” the femoral mechanical axis 28 and the tibial mechanical axis 38. Thereafter, computing functionality 18 can construct the tibial reference plane 40.
After the mechanical axis and other rotation axes and constructs relating to the femur and tibia are established, instrumentation can be properly oriented to resect or modify bone in order to properly fit trial components and implant components. Instrumentation such as, for instance, cutting blocks, to which fiducials 14 are mounted, can be employed. The system 100 can then track instrumentation as the surgeon manipulates it for optimum positioning. In other words, the surgeon can “navigate” the instrumentation for optimum positioning using the system and the monitor. In this manner, instrumentation may be positioned according to the system of this embodiment in order to align the ostetomies to the mechanical and rotational axes or reference axes and planes on a rod (extramedullary, intramedullary, or other type) that does not violate the canal. The monitor 24 also can then display the instrument, such as the cutting block and/or the implant relative to the instrument and the rod during this process, in order to, among other things, properly select implant size and perhaps implant type. As the instrument moves, the varus/valgus, flexion/extension and internal/external rotation of the relative component position can be calculated and shown with respect to the referenced axes; in some embodiments, this can be done at a rate of six cycles per second or faster. The instrument position is then fixed in the computer and physically, and the surgeon makes the bone resections.
Once the extramedullary rod, intramedullary rod, other type of rod has been placed, instrumentation can be positioned as tracked in position and orientation by sensor 16 and displayed on screen face 24. Thus, a cutting block of the sort used to establish the condylar anterior cut, with its fiducial 14 attached, is introduced into the field and positioned on the rod.
In a similar fashion, instrumentation may be navigated and positioned on the proximal portion of the tibia 10 as shown in
In summary, the computer 18 and monitor 24 show femoral component and tibial component overlays according to certain position and orientation of cutting blocks/instrumentation as bone resections are made. The surgeon can thus visualize where the implant components will be and can assess fit, and other things if desired, before resections are made.
Once resection and modification of bone has been accomplished, implant trials can then be installed and tracked by the system 100 in a manner similar to navigating and positioning the instrumentation, as displayed on the screen 24. Thus, a femoral component trial, a tibial plateau trial, and a bearing plate trial may be placed as navigated on screen using computer generated overlays corresponding to the trials.
During the trial installation process, and also during the implant component installation process, instrument positioning process or at any other desired point in surgical or other operations, the system 100 can transition or segue from tracking a component according to a first fiducial to tracking the component according to a second fiducial. Thus, as shown as
The tibial trial may be placed on the proximal tibia and then registered using the probe 26. Probe 26 is used to designate preferably at least three features on the tibial trial of known coordinates, such as bone spike holes. As the probe 26 is placed onto each feature, the system 100 is prompted to save that coordinate position so that the system 100 can match the tibial trial's feature's coordinates to the saved coordinates. The system 100 then tracks the tibial trial relative to the tibial anatomical reference frame.
Once the trial components are installed, the surgeon can assess alignment and stability of the components and the joint. During such assessment, in trial reduction, the computer can display on monitor 24 the relative motion between the trial components to allow the surgeon to make soft tissue releases and changes in order to improve the kinematics of the knee. The system 100 can also apply rules and/or intelligence to make suggestions based on the information such as what soft tissue releases to make if the surgeon desires. The system 100 can also display how the soft tissue releases are to be made.
At the end of the case, all alignment information can be saved for the patient file. This is of great assistance to the surgeon due to the fact that the outcome of implant positioning can be seen before any resections have been made to the bone. The system 100 is also capable of tracking the patella and resulting placement of cutting guides and the patellar trial position. The system 100 then tracks alignment of the patella with the patellar femoral groove and will give feedback on issues, such as, patellar tilt.
The tracking and image information provided by the system 100 facilitate telemedical techniques because it provides useful images for distribution to distant geographic locations where expert surgical or medical specialists may collaborate during surgery. Thus, the system can be used in connection with computing functionality 18 which is networked or otherwise in communication with computing functionality in other locations, whether by public switched telephone network (PSTN), information exchange infrastructures, such as packet switched networks, including the Internet. Such remote imaging may occur on computers, wireless devices, videoconferencing devices or in any other mode or on any other platform which is now or may in the future be capable of rending images or parts of them. Parallel communication links, such as switched or unswitched telephone call connections, may also accompany or form part of such telemedical techniques. Distant databases, such as online catalogs of implant suppliers or prosthetics buyers or distributors, may form part of or be networked with functionality 18 to give the surgeon in real time access to additional options for implants which could be procured and used during the surgical operation.
The invention may include one or more of the following steps. An optional first step is to obtain appropriate images, such as fluoroscopy images of appropriate body parts. This first step may include tracking the imager via an associated fiducial whose position and orientation is tracked by position/orientation sensors, such as stereoscopic infrared (active or passive) sensors. A second step is to register tools, instrumentation, trial components, prosthetic components, and other items to be used in surgery. The second step may include associating the tool, instrument, trial component, prosthetic component, or other device with a corresponding fiducial. A third step is to locate and register body structure, such as designating points on the femur and tibia using a probe associated with a fiducial, in order to provide the processing functionality information relating to the body part, such as rotational axes. A fourth step is to navigate and position instrumentation, such as cutting instrumentation, in order to modify bone, at least partially using images generated by the processing functionality corresponding to what is being tracked and/or has been tracked, and/or is predicted by the system, and thereby resecting bone effectively, efficiently and accurately. A fifth step is to navigate and position trial components, such as femoral components and tibial components, some or all of which may be installed using impactors with a fiducial and, if desired, at the appropriate time discontinuing tracking the position and orientation of the trial component using the impactor fiducial and starting to track that position and orientation using the body part fiducial on which the component is installed. A sixth step is to assess alignment and stability of the trial components and joint, both statically and dynamically as desired, using images of the body parts in combination with images of the trial components while conducting appropriate rotation, anterior-posterior drawer and flexion/extension tests and automatically storing and calculating results to present data or information which allows the surgeon to assess alignment and stability. A seventh step includes the release of tissue, such as ligaments, if necessary and adjusting trial components as desired for acceptable alignment and stability. An eighth step includes installation of implant components whose positions may be tracked at first via fiducials associated with impactors for the components and then tracked via fiducials on the body parts in which the components are installed. A ninth step includes assessing alignment and stability of the implant components and joint by use of some or all tests mentioned above and/or other tests as desired, releasing tissue if desired, adjusting if desired, and otherwise verifying acceptable alignment, stability and performance of the prosthesis, both statically and dynamically. Some or all of these steps may be used in any total or partial joint repair, reconstruction or replacement, including knees, hips, shoulders, elbows, ankles and any other desired joint in the body.
The system uses computer capacity, including standalone and/or networked computer capacity, to store data regarding spatial aspects of surgically related items and virtual constructs or references including body parts, implements, instrumentation, trial components, prosthetic components and rotational axes of body parts. Any or all of these may be physically or virtually connected to or incorporate any desired form of mark, structure, component, or other fiducial or reference device or technique which allows position and/or orientation of the item to which it is attached to be sensed and tracked, preferably in three dimensions of translation and three degrees of rotation as well as in time if desired. As an example, such “fidicuals” are reference frames each containing at least three, preferably four, sometimes more, reflective elements, such as spheres reflective of lightwave or infrared energy, or active elements, such as light emitting diodes (LEDs).
In one embodiment, orientation of the elements on a particular fiducial varies from one fiducial to the next so that sensors may distinguish between various components to which the fiducials are attached in order to correlate for display and other purposes data files or images of the components. The fiducials may be active, passive, or some combination thereof. In other words, some fiducials use reflective elements and some use active elements, both of which may be tracked by preferably two, sometimes more infrared sensors whose output may be processed in concert to geometrically calculate position and orientation of the item to which the fiducial is attached.
Position/orientation tracking sensors and fiducials need not be confined to the infrared spectrum. Any electromagnetic, electrostatic, light, sound, radiofrequency or other desired technique may be used. Alternatively, each item, such as a surgical implement, instrumentation component, trial component, implant component or other device may contain its own “active” fiducial, such as a microchip with appropriate field sensing or position/orientation sensing functionality and communications link, such as spread spectrum radio frequency (RF) link, in order to report position and orientation of the item. Such active fiducials, or hybrid active/passive fiducials, such as transponders, can be implanted in the body parts or in any of the surgically related devices mentioned above or conveniently located at their surface or otherwise as desired. Fiducials may also take the form of conventional structures, such as a screw driven into a bone, or any other three dimensional item attached to another item, position and orientation of such three dimensional item able to be tracked in order to track position and orientation of body parts and surgically related items. Hybrid fiducials may be partly passive, partly active such as inductive components or transponders which respond with a certain signal or data set when queried by sensors.
The system employs a computer to calculate and store reference axes of body components, such as in a total knee arthroplasty, for example, the mechanical axis of the femur and tibia. From these axes such systems track the position of the instrumentation and osteotomy guides so that bone resections will locate the implant position optimally, usually aligned with the mechanical axis. Furthermore, during trial reduction of the knee, the system provides feedback on the balancing of the ligaments in a range of motion and under varus/valgus, anterior/posterior and rotary stresses and can suggest or at least provide more accurate information than in the past about which ligaments the surgeon should release in order to obtain correct balancing, alignment and stability. The system can also suggest modifications to implant size, positioning, and other techniques to achieve optimal kinematics. The system can also include databases of information regarding tasks such as ligament balancing, in order to provide suggestions to the surgeon based on performance of test results as automatically calculated by such systems and processes.
The invention also includes a computerized method for determining tibial rotation within a coordinate system. The method may include one or more of the following steps, which are provided in no particular order. A first step of the method is to provide a computer having a processor, a memory, and an input/output device. A second step is to identify a mechanical axis of a femur. A third step is to identify a mechanical axis of a tibia. A fourth step is to place the tibia in about 90 degrees of flexion relative to the femur. A fifth step is to construct a plane through the mechanical axis of the tibia and orthogonal to the mechanical axis of the femur. The constructed plane may be used to create a tibial coordinate system which includes the mechanical axis of the tibia, an anteroposterior axis and a medial-lateral axis. A sixth step is to identify an orientation of the plane relative to other fiducials or a global coordinate system. A seventh step is to store the orientation of the plane in the memory of the computer. An eighth step is to measure an angular rotation of an item relative to the plane and the mechanical axis of the tibia or to the tibial coordinate system. Items may include, but are not limited to, tools, instruments, trial components, and prosthetic devices. The step of identifying a mechanical axis of a femur may include the step of locating data points corresponding to structure of the femur. The step of identifying a mechanical axis of a tibia may include the step of locating data points corresponding to structure of the tibia.
The invention may also include one or more of the following optional steps. For example, the method may include the step of storing in the memory the mechanical axis of the femur or the step of storing in the memory the mechanical axis of tibia. The method may include the step of obtaining images of body parts, the step of registering items, or the steps of locating and registering body structure. Finally, the method may include the step of mounting a fiducial to a body part or the step of displaying the constructed plane on a monitor.
The invention further includes a process for conducting knee surgery using a surgical navigation system. The process may include one or more of the following steps, which are provided in no particular order. A first step of the method is to identify a first axis of a first bone. A second step is to track an orientation of the first axis relative to the first bone. A third step is to identify a second axis of a second bone. A fourth step is to track an orientation of the second axis relative to the second bone. A fifth step is to place the second bone in about 90 degrees of flexion relative to the first bone. A sixth step is to construct a plane through the second axis and orthogonal to the first axis. A seventh step is to track an orientation of the constructed plane. An eighth step is to expose bones in a vicinity of a knee joint. A ninth step is to measure an angular rotation of an item relative to the constructed plane and the second axis. Items may include, but are not limited to, tools, instruments, trial components, and prosthetic devices. A tenth step is to at least partially resect the first bone. An eleventh step is to close the exposed knee. An optional step may be to attach a surgical implant to the at least partially resected first bone.
In view of the foregoing, it will be seen that the several advantages of the invention are achieved and attained.
The embodiments were chosen and described in order to best explain the principles of the invention and its practical application to thereby enable others skilled in the art to best utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated.
As various modifications could be made in the constructions and methods herein described and illustrated without departing from the scope of the invention, it is intended that all matter contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. For example, while some embodiments are illustrated in conjunction with total knee arthroplasty (TKA), those of ordinary skill in the art would understand that the invention may equally be applied to unicompartmental knee arthroplasty (UKA), bicompartmental knee arthroplasty, or articulating joint resurfacing. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.
This application claims the benefit of U.S. Provisional Application No. 60/677,399, filed 2 May 2005.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US06/17042 | 5/2/2006 | WO | 00 | 11/2/2007 |
Number | Date | Country | |
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60677399 | May 2005 | US |