Source: http://www.google.com/patents/US20070123912?dq=5,915,131
Timestamp: 2015-07-30 12:41:25
Document Index: 583750400

Matched Legal Cases: ['art. 45', 'art. 46', 'art. 51', 'art. 55', 'art. 58', 'art. 65', 'art. 68', 'Application No. 60', 'Application No. 60', 'arts 10', 'arts 10', 'arts 10', 'arts 10', 'arts 10']

Patent US20070123912 - Surgical navigation systems and processes for unicompartmental knee arthroplasty - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsSystems and processes for tracking anatomy, instrumentation, trial implants, implants, and references, and rendering images and data related to them in connection with surgical operations, for example unicompartmental knee arthroplasties (“UKA”). These systems and processes are accomplished by using...http://www.google.com/patents/US20070123912?utm_source=gb-gplus-sharePatent US20070123912 - Surgical navigation systems and processes for unicompartmental knee arthroplastyAdvanced Patent SearchPublication numberUS20070123912 A1Publication typeApplicationApplication numberUS 11/645,295Publication dateMay 31, 2007Filing dateDec 22, 2006Priority dateFeb 27, 2001Also published asCA2579719A1, EP1799140A1, US20050113846, WO2006044367A1Publication number11645295, 645295, US 2007/0123912 A1, US 2007/123912 A1, US 20070123912 A1, US 20070123912A1, US 2007123912 A1, US 2007123912A1, US-A1-20070123912, US-A1-2007123912, US2007/0123912A1, US2007/123912A1, US20070123912 A1, US20070123912A1, US2007123912 A1, US2007123912A1InventorsChristopher CarsonOriginal AssigneeCarson Christopher PExport CitationBiBTeX, EndNote, RefManReferenced by (6), Classifications (36) External Links: USPTO, USPTO Assignment, EspacenetSurgical navigation systems and processes for unicompartmental knee arthroplasty
US 20070123912 A1Abstract
Systems and processes for tracking anatomy, instrumentation, trial implants, implants, and references, and rendering images and data related to them in connection with surgical operations, for example unicompartmental knee arthroplasties (“UKA”). These systems and processes are accomplished by using a computer to intraoperatively obtain images of body parts and to register, navigate, and track surgical instruments. Images(43) Claims(31)
1-41. (canceled) 42. A system for performing unicompartmental knee arthroplasty surgical operations on portions of a knee joint, comprising: (a) a locator for obtaining data corresponding to structure of a body part forming a portion of a knee joint, wherein the body part and the locator are each associated with a fiducial; (b) a unicompartmental knee arthroplasty surgical instrument associated with a fiducial; (c) at least one position sensor for tracking positions of the fiducials; (d) a computer for receiving signals from the at least one position sensor and for tracking a position of a virtual construct based at least in part on the position of the fiducial associated with the body part and the data; and (e) a monitor for displaying at least a representation of the position of the virtual construct. 43. The system of claim 42, wherein the locator comprises a C-arm fluoroscope, a CT scanner, MRI equipment, ultrasound equipment, laser scanning equipment, or a probe. 44. The system of claim 42, wherein the locator comprises a probe, and wherein the probe is used to designate at least one landmark on the body part. 45. The system of claim 44, wherein the at least one landmark defines an axis of the body part. 46. The system of claim 42, wherein the body part comprises a femur, a tibia or a patella. 47. The system of claim 42, wherein the fiducials comprise active fiducials, passive fiducials, or hybrid active/passive fiducials. 48. The system of claim 47, wherein the position sensor comprises an infrared sensor, an electromagnetic sensor, an electrostatic sensor, a light sensor, a sound sensor, a radio frequency sensor, or a physical sensor. 49. The system of claim 42, wherein the unicompartmental knee arthroplasty surgical instrument comprises a cutting block or a rod. 50. The system of claim 42, wherein the computer generates numerical data based at least in part on the position of the fiducial associated with the body part. 51. The system of claim 50, wherein the numerical data is used to assess performance of a knee implant. 52. The system of claim 51, wherein the numerical data is used to assess performance of a trial knee implant. 53. The system of claim 51, wherein the numerical data is used to evaluate modifying tissues associated with the knee joint. 54. The system of claim 42, wherein the virtual construct comprises an axis of the body part. 55. The system of claim 54, wherein the virtual construct comprises a mechanical axis of the femur. 56. The system of claim 54, wherein the virtual construct comprises a mechanical axis of the tibia. 57. The system of claim 42, wherein the virtual construct comprises at least one landmark of the body part. 58. A system for performing unicompartmental knee arthroplasty surgical operations on portions of a knee joint, comprising: (a) a locator for obtaining data corresponding to structure of a body part forming a portion of a knee joint, wherein the body part and the locator are each associated with a fiducial; (b) a unicompartmental knee arthroplasty surgical instrument associated with a fiducial; (c) at least one position sensor for tracking positions of the fiducials; (d) a computer for receiving signals from the at least one position sensor and for generating numerical data based at least in part on the position of the fiducial associated with the body part and the data; and (e) a monitor for displaying at least the numerical data. 59. The system of claim 58, wherein the numerical data is used to assess performance of a knee implant. 60. The system of claim 59, wherein the numerical data is used to assess performance of a trial knee implant. 61. The system of claim 59, wherein the numerical data is used to evaluate modifying tissues associated with the knee joint. 62. The system of claim 61, wherein the tissue comprises at least one ligament. 63. The system of claim 58, wherein the computer tracks a position of a virtual construct based at least in part on the position of the fiducial associated with the body part and the data. 64. The system of claim 63, wherein the virtual construct comprises an axis of the body part. 65. The system of claim 63, wherein the virtual construct comprises a mechanical axis of the femur. 66. The system of claim 63, wherein the virtual construct comprises a mechanical axis of the tibia. 67. The system of claim 63, wherein the virtual construct comprises a landmark of the body part. 68. The system of claim 58, wherein the locator comprises a C-arm fluoroscope, a CT scanner, MRI equipment, ultrasound equipment, laser scanning equipment, or a probe. 69. The system of claim 58, wherein the fiducials comprise active fiducials, passive fiducials, or hybrid active/passive fiducials. 70. The system of claim 69, wherein the position sensor comprises an infrared sensor, an electromagnetic sensor, an electrostatic sensor, a light sensor, a sound sensor, a radio frequency sensor, or a physical sensor. 71. The system of claim 58, wherein the unicompartmental knee arthroplasty surgical instrument comprises a cutting block or a rod.
RELATED APPLICATION DATA This document is a continuation application of U.S. patent application Ser. No. 10/963,862, entitled “Surgical Navigation Systems and Processes for Unicompartmental Knee Arthroplasty” and filed Oct. 13, 2004, which is a continuation-in-part application U.S. patent application Ser. No. 10/084,278, entitled “Surgical Navigation Systems and Processes for Unicompartmental Knee Arthroplasty,” filed Feb. 27, 2002 and now issued as U.S. Pat. No. 6,827,723, which claims the benefit of U.S. Provisional Patent Application No. 60/271,818, filed Feb. 27, 2001 and entitled “Image Guided System for Arthoplasty,” and U.S. Provisional Patent Application No. 60/355,899, filed on Feb. 11, 2002 and entitled “Surgical Navigation Systems and Processes,” all of which are hereby incorporated in their entirety by this reference.
DETAILED DESCRIPTION Systems and processes according to a preferred embodiment of the present invention use computer capacity, including standalone and/or networked, 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. In a preferred embodiment, orientation of the elements on a particular fiducial varies from one fiducial to the next so that sensors according to the present invention 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. In a preferred embodiment of the present invention, 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. In some preferred embodiments, fiducials are only temporarily attached to the body part, surgical instrument or other item. In still other preferred embodiments of the present invention, the fiducials are modular, allowing the surgeon or other user to position individual reflective elements on the body part, surgical instrument or other item such that the fiducial is positioned for maximum visibility by the sensors. FIG. 40 shows schematically the use of modular fiducials 200 on a body part, item and instrument. Exemplary fiducials useable in various embodiments of the present invention are also disclosed in United States Patent Applications U.S. Ser. No. 10/679,158, entitled “Surgical Positioners” and filed Oct. 3, 2003, U.S. Ser. No. 10/689,103, entitled “Surgical Navigation System Component Fault Interfaces and Related Processes” and filed Oct. 20, 2003, and U.S. Ser. No. 10/897,857, entitled “Surgical Navigation System Component Fault Interfaces and Related Processes” and filed Jul. 23, 2004, all of which are herein expressly incorporated by this reference. Position/orientation tracking sensors and fiducials need not be confined to the infrared spectrum. Any electromagnetic, electrostatic, light, sound, radio frequency 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 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 according to the present invention. Systems and processes according to a preferred embodiment of the present invention employ a computer to calculate and store reference axes of body components such as in a UKA, 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 systems provide 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. Systems and processes according to the present invention can also suggest modifications to implant size, positioning, and other techniques to achieve optimal kinematics. Systems and processes according to the present invention 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. FIG. 1 is a schematic view showing one embodiment of a system according to the present invention and one version of a setting according to the present invention in which surgery on a knee, in this case a Unicompartmental Knee Arthroplasty, may be performed. Systems and processes according to the present invention can track various body parts such as tibia 10 and femur 12 to which fiducials of the sort described above or any other sort may be implanted, attached, or otherwise associated physically, virtually, or otherwise. In the embodiment shown in FIG. 1, fiducials 14 are structural frames some of which contain reflective elements, some of which contain LED active elements, some of which can contain both, for tracking using stereoscopic infrared sensors suitable, at least operating in concert, for sensing, storing, processing and/or outputting data relating to (“tracking”) position and orientation of fiducials 14 and thus components such as 10 and 12 to which they are attached or otherwise associated. Position sensor 16, as mentioned above, may be any sort of sensor functionality for sensing position and orientation of fiducials 14 and therefore items with which they are associated, according to whatever desired electrical, magnetic, electromagnetic, sound, physical, radio frequency, or other active or passive technique. In the preferred embodiment, position sensor 16 is a pair of infrared sensors disposed on the order of a meter, sometimes more, sometimes less, apart and whose output can be processed in concert to provide position and orientation information regarding fiducials 14. In the embodiment shown in FIG. 1, computing functionality 18 can include processing functionality, memory functionality, input/output functionality whether on a standalone or distributed basis, via any desired standard, architecture, interface and/or network topology. In this embodiment, computing functionality 18 is connected to a monitor on which graphics and data may be presented to the surgeon during surgery. The screen preferably has a tactile interface so that the surgeon may point and click on screen for tactile screen input in addition to or instead of, if desired, keyboard and mouse conventional interfaces. Additionally, a foot pedal 20 or other convenient interface may be coupled to functionality 18 as can any other wireless or wireline interface to allow the surgeon, nurse or other desired user to control or direct functionality 18 in order to, among other things, capture position/orientation information when certain components are oriented or aligned properly. Items 22 such as trial components, instrumentation components may be tracked in position and orientation relative to body parts 10 and 12 using fiducials 14. Computing functionality 18 can process, store and output on monitor 24 and otherwise various forms of data which correspond in whole or part to body parts 10 and 12 and other components for item 22. For example, in the embodiment shown in FIG. 1, body parts 10 and 12 are shown in cross-section or at least various internal aspects of them such as bone canals and surface structure are shown using fluoroscopic images. These images are obtained using a C-arm attached to a fiducial 14. The body parts, for example, tibia 10 and femur 12, also have fiducials attached. When the fluoroscopy images are obtained using the C-arm with fiducial 14, a position/orientation sensor 16 “sees” and tracks the position of the fluoroscopy head as well as the positions and orientations of the tibia 10 and femur 12. The computer stores the fluoroscopic images with this position/orientation information, thus correlating position and orientation of the fluoroscopic image relative to the relevant body part or parts. Thus, when the tibia 10 and corresponding fiducial 14 move, the computer automatically and correspondingly senses the new position of tibia 10 in space and can correspondingly move implements, instruments, references, trials and/or implants on the monitor 24 relative to the image of tibia 10. Similarly, the image of the body part can be moved, both the body part and such items may be moved, or the on screen image otherwise presented to suit the preferences of the surgeon or others and carry out the imaging that is desired. Similarly, when an item 22, such as a cutting block, reamer, drill, saw, extramedullary rod, intramedullar rod, or any other type of item or instrument, that is being tracked moves, its image moves on monitor 24 so that the monitor shows the item 22 in proper position and orientation on monitor 24 relative to the femur 12: The item 22 can thus appear on the monitor 24 in proper or improper alignment with respect to the mechanical axis and other features of the femur 12, as if the surgeon were able to see into the body in order to navigate and position rod 22 properly. The computer functionality 18 can also store data relating to configuration, size and other properties of items 22 such as implements, instrumentation, trial components, implant components and other items used in surgery. When those are introduced into the field of position/orientation sensor 16, computer functionality 18 can generate and display overlain or in combination with the fluoroscopic images of the body parts 10 and 12, computer generated images of implements, instrumentation components, trial components, implant components and other items 22 for navigation, positioning, assessment and other uses. Computer functionality 18 may also store and output virtual construct data based on the sensed position and orientation of items in the surgical field, such as surgical instruments. For example, as shown in FIG. 41, monitor 24 may output a resection plane 202 that corresponds to the resection plane defined by a cutting guide whose position and orientation is being tracked by sensors 16. In other embodiments, such as in the embodiment shown in FIG. 42, monitor 24 may output a cutting track 204 based on the sensed position and orientation of a reamer. Other virtual constructs may also be output on monitor 24, and can be displayed with or without the relevant surgical instrument, based on the sensed position and orientation of any surgical instrument or other item in the surgical field to assist the surgeon or other user to plan some or all of the stages of the surgical procedure. In some preferred embodiments of the present invention, computer functionality may output on monitor 24 the projected position and orientation of an implant component or components based on the sensed position and orientation of one or more surgical instruments associated with fiducials. For example, the system may track the position and orientation of a cutting block as it is navigated with respect to a portion of a body part that will be resected. Computer functionality 18 may calculate and output on monitor 24 the projected placement of the implant in the body part based on the sensed position and orientation of the cutting block. If the surgeon or other user is dissatisfied with the projected placement of the implant, the surgeon may then reposition the cutting block to evaluate the effect on projected implant position and orientation. Additionally, computer functionality 18 can track any point in the position/orientation sensor 16 field such as by using a designator or a probe 26. The probe also can contain or be attached to a fiducial 14. 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 thus calculates and stores, and can display on monitor 24 whenever desired and in whatever form or fashion or color, the point or other position designated by probe 26 when the foot pedal 20 is hit or other command is given. 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 bone fiducial 14, virtual or logical information such as mechanical axis 28, medial laterial 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. Systems and processes according to an embodiment of the present invention such as the subject of FIGS. 2-36, can use the so-called FluoroNAV system and software provided by Medtronic Sofamor Danek Technologies. Such systems or aspects of them are disclosed in U.S. Pat. Nos. 5,383,454; 5,871,445; 6,146,390; 6,165,81; 6,235,038 and 6,236,875, and related (under 35 U.S.C. Section 119 and/or 120) patents, which are all incorporated herein by this reference. Any other desired systems can be used as mentioned above for imaging, storage of data, tracking of body parts and items and for other purposes. The FluoroNav system requires the use of reference frame type fiducials 14 which have four and in some cases five elements tracked by infrared sensors for position/orientation of the fiducials and thus of the body part, implement, instrumentation, trial component, implant component, or other device or structure being tracked. Such systems also use at least one probe 26 which the surgeon can use to select, designate, register, or otherwise make known to the system a point or points on the anatomy or other locations by placing the probe as appropriate and signaling or commanding the computer to note the location of, for instance, the tip of the probe. The FluoroNav system also tracks position and orientation of a C-arm used to obtain fluoroscopic images of body parts to which fiducials have been attached for capturing and storage of fluoroscopic images keyed to position/orientation information as tracked by the sensors 16. Thus, the monitor 24 can render fluoroscopic images of bones in combination with computer generated images of virtual constructs and references together with implements, instrumentation components, trial components, implant components and other items used in connection with surgery for navigation, resection of bone, assessment and other purposes. FIGS. 2-39 are various views associated with Unicompartmental Knee Arthroplasty surgery processes according to one particular embodiment and version of the present invention being carried out with the FluoroNav system referred to above. FIG. 2 shows a human knee in the surgical field, as well as the corresponding femur and tibia to which fiducials 14 have been rigidly attached in accordance with this embodiment of the invention. Attachment of fiducials 14 preferably is accomplished using structure that withstands vibration of surgical saws and other phenomenon which occur during surgery without allowing any substantial movement of fiducial 14 relative to body part being tracked by the system. FIG. 3 shows fluoroscopy images being obtained of the body parts with fiducials 14 attached. The fiducial 14 on the fluoroscopy head in this embodiment is a cylindrically shaped cage which contains LEDs or “active” emitters for tracking by the sensors 16. Fiducials 14 attached to tibia 10 and femur 12 can also be seen. The fiducial 14 attached to the femur 12 uses LEDs instead of reflective spheres and is thus active, fed power by the wire seen extending into the bottom of the image. FIGS. 4-10 are fluoroscopic images shown on monitor 24 obtained with position and/or orientation information received by, noted and stored within computer 18. FIG. 4 is an open field with no body part image, but which shows the optical indicia which may be used to normalize the image obtained using a spherical fluoroscopy wave front with the substantially flat surface of the monitor 24. FIG. 5 shows an image of the femur 12 head. This image is taken in order to allow the surgeon to designate the center of rotation of the femoral head for purposes of establishing the mechanical axis and other relevant constructs relating to of the femur according to which the prosthetic components will ultimately be positioned. Such center of rotation can be established by articulating the femur within the acetabulum or a prosthesis to capture a number of samples of position and orientation information and thus in turn to allow the computer to calculate the average center of rotation. The center of rotation can be established by using the probe and designating a number of points on the femoral head and thus allowing the computer to calculate the geometrical center or a center which corresponds to the geometry of points collected. Additionally, graphical representations such as controllably sized circles displayed on the monitor can be fitted by the surgeon to the shape of the femoral head on planar images using tactile input on screen to designate the centers according to that graphic, such as are represented by the computer as intersection of axes of the circles. Other techniques for determining, calculating or establishing points or constructs in space, whether or not corresponding to bone structure, can be used in accordance with the present invention. FIG. 5 shows a fluoroscopic image of the femoral head while FIG. 6 shows an anterior/posterior view of the knee which can be used to designate landmarks and establish axes or constructs such as the mechanical axis or other rotational axes. FIG. 7 shows the distal end of the tibia and FIG. 8 shows a lateral view of the knee. FIG. 9 shows another lateral view of the knee while FIG. 10 shows a lateral view of the distal end of the tibia. Registration of Surgically Related Items FIGS. 11-14 show designation or registration of items 22 which will be used in surgery. Registration simply means, however it is accomplished, ensuring that the computer knows which body part, item or construct corresponds to which fiducial or fiducials, and how the position and orientation of the body part, item or construct is related to the position and orientation of its corresponding fiducial or a fiducial attached to an impactor or other component which is in turn attached to an item. Such registration or designation can be done before or after registering bone or body parts as discussed with respect to FIGS. 4-10. FIG. 11 shows a technician designating with probe 26 an item 22 such as an instrument component to which fiducial 14 is attached. The sensor 16 “sees” the position and orientation of the fiducial 14 attached to the item 22 and also the position and orientation of the fiducial 14 attached to the probe 26 whose tip is touching a landmark on the item 22. The technician designates onscreen or otherwise the identification of the item and then activates the foot pedal or otherwise instructs the computer to correlate the data corresponding to such identification, such as data needed to represent a particular cutting block component for a particular knee implant product, with the particularly shaped fiducial 14 attached to the component 22. The computer has then stored identification, position and orientation information relating to the fiducial for component 22 correlated with the data such as configuration and shape data for the item 22 so that upon registration, when sensor 16 tracks the item 22 fiducial 14 in the infrared field, monitor 24 can show the cutting block component 22 moving and turning, and properly positioned and oriented relative to the body part which is also being tracked. FIGS. 12-14 show similar registration for other instrumentation components 22. Registration of Anatomy and Constructs Similarly, the mechanical axis and other axes or constructs of body parts 10 and 12 can also be “registered” for tracking by the system. Again, the system has employed a fluoroscope to obtain images of the femoral head, knee and ankle of the sort shown in FIGS. 4-10. The system correlates such images with the position and orientation of the C-arm and the patient anatomy in real time as discussed above with the use of fiducials 14 placed on the body parts before image acquisition and which remain in position during the surgical procedure. Using these images and/or the probe, the surgeon can select and register in the computer 18 the center of the femoral head and ankle in orthogonal views, usually anterior/posterior and lateral, on a touch screen. The surgeon uses the probe to select any desired anatomical landmarks or references at the operative site of the knee or on the skin or surgical draping over the skin, as on the ankle. These points are registered in three dimensional space by the system and are tracked relative to the fiducials on the patient anatomy which are preferably placed intraoperatively. FIG. 15 shows the surgeon using probe 26 to designate or register landmarks on the condylar portion of femur 12 using probe 26 in order to feed to the computer 18 the position of one point needed to determine, store, and display the epicondylar axis. (See FIG. 20 which shows the epicondylar axis and the anterior-posterior plane and for lateral plane.) Although registering points using actual bone structure such as in FIG. 15 is one preferred way to establish the axis, a cloud of points approach by which the probe 26 is used to designate multiple points on the surface of the bone structure can be employed, as can moving the body part and tracking movement to establish a center of rotation as discussed above. Once the center of rotation for the femoral head and the condylar component have been registered, the computer is able to calculate, store, and render, and otherwise use data for, the mechanical axis of the femur 12. FIG. 17 once again shows the probe 26 being used to designate points on the condylar component of the femur 12. FIG. 18 shows the onscreen images being obtained when the surgeon registers certain points on the bone surface using the probe 26 in order to establish the femoral mechanical axis. The tibial mechanical axis is then established by designating points to determine the centers of the proximal and distal ends of the tibia so that the mechanical axis can be calculated, stored, and subsequently used by the computer 18. FIG. 20 shows designated points for determining the epicondylar axis, both in the anterior/posterior and lateral planes while FIG. 21 shows such determination of the anterior-posterior axis as rendered onscreen. The posterior condylar axis is also determined by designating points or as otherwise desired, as rendered on the computer generated geometric images overlain or displayed in combination with the fluoroscopic images, all of which are keyed to fiducials 14 being tracked by sensors 16. FIG. 23 shows an adjustable circle graphic which can be generated and presented in combination with orthogonal fluoroscopic images of the femoral head, and tracked by the computer 18 when the surgeon moves it on screen in order to establish the centers of the femoral head in both the anterior-posterior and lateral planes. FIG. 24 is an onscreen image showing the anterior-posterior axis, epicondylar axis and posterior condylar axis from points which have been designated as described above. These constructs are generated by the computer 18 and presented on monitor 24 in combination with the fluoroscopic images of the femur 12, correctly positioned and oriented relative thereto as tracked by the system. In the fluoroscopic/computer generated image combination shown at left bottom of FIG. 24, a “sawbones” knee as shown in certain drawings above which contains radio opaque materials is represented fluoroscopically and tracked using sensor 16 while the computer generates and displays the mechanical axis of the femur 12 which runs generally horizontally. The epicondylar axis runs generally vertically, and the anterior/posterior axis runs generally diagonally. The image at bottom right shows similar information in a lateral view. Here, the anterior-posterior axis runs generally horizontally while the epicondylar axis runs generally diagonally, and the mechanical axis generally vertically. FIG. 24, as is the case with a number of screen presentations generated and presented by the system of FIGS. 4-39, also shows at center a list of landmarks to be registered in order to generate relevant axes and constructs useful in navigation, positioning and assessment during surgery. Textural cues may also be presented which suggest to the surgeon next steps in the process of registering landmarks and establishing relevant axes. Such instructions may be generated as the computer 18 tracks, from one step to the next, registration of items 22 and bone locations as well as other measures being taken by the surgeon during the surgical operation. FIG. 25 shows mechanical, lateral, anterior-posterior axes for the tibia according to points are registered by the surgeon. FIG. 26 is another onscreen image showing the axes for the femur 12. Any desired axes or other constructs can be created, tracked and displayed, in order to model and generate images and data showing any desired static or kinematic function of the knee for any purposes related to a UKA. Modifying Bone 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 fit trial components and implant components properly according to the embodiment of the invention shown in FIGS. 4-39. Instrumentation such as, for instance, cutting blocks, to which fiducials 14 are mounted, can be employed. The system 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 on an extramedullary rod that does not violate the canal, on an intramedullary rod, or on any other type of rod. The touchscreen 24 can then also display the instrument such as the cutting block and/or the implant relative to the instrument and the rod during this process, in order, among other things, properly to select size of implant 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 the preferred embodiment, 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 bone resections are made. FIG. 27 shows orientation of an extramedullary rod to which a fiducial 14 is attached via impactor 22. The surgeon views the screen 24 which has an image as shown in FIG. 29 of the rod overlain on or in combination with the femur 12 fluoroscopic image as the two are actually positioned and oriented relative to one another in space. The surgeon then navigates the rod into place preferably along the mechanical axis of the femur and drives it home with appropriate mallet or other device. The present invention thus avoids the need to bore a hole in the metaphysis of the femur and place a reamer or other rod into the medullary canal which can cause fat embolism, hemorrhaging, infection and other untoward and undesired effects. FIG. 28 also shows the extramedullary rod being located. FIG. 29 shows fluoroscopic images, both anterior-posterior and lateral, with axes, and with a computer generated and tracked image of the rod superposed or in combination with the fluoroscopic images of the femur and tibia. FIG. 30 shows the rod superimposed on the femoral fluoroscopic image similar to what is shown in FIG. 29. FIG. 29 also shows other information relevant to the surgeon such as the name of the component being overlain on the femur image, suggestions or instructions at the lower left, and angle of the rod in varus/valgus and extension relative to the axes. Any or all of this information can be used to navigate and position the rod relative to the femur. At a point in time during or after placement of the rod, its tracking may be “handed off” from the impactor fiducial 14 to the femur fiducal 14 as discussed below. Once the extramedullary rod, intramedullary rod, or any 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. Because the cutting block corresponds to a particular implant product and can be adjusted and designated on screen to correspond to a particular implant size of that product, the computer 18 can generate and display a graphic of the cutting block and the femoral component overlain on the fluoroscopic image. The surgeon can thus navigate and position the cutting block on screen using not only images of the cutting block on the bone, but also images of the corresponding femoral component which will be ultimately installed. The surgeon can thus adjust the positioning of the physical cutting block component, and secure it to the rod in order to resect the anterior of the condylar portion of the femur in order to optimally fit and position the ultimate femoral component being shown on the screen. Other cutting blocks and other resections may be positioned and made similarly on the condylar component. In a similar fashion, instrumentation may be navigated and positioned on the proximal portion of the tibia 10 and as tracked by sensor 16 and on screen by images of the cutting block and the implant component. FIGS. 33-37 show instrumentation being positioned relative to femur 12 as tracked by the system for resection of the condylar component in order to receive a particular size of implant component. Various cutting blocks and their attached fiducials can be seen in these views. Navigation, Placement and Assessment of Trials and Implants Once resection and modification of bone has been accomplished, implant trials can then be installed and tracked by the system 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 according to the present invention, the system can transition or segue from tracking a component according to a first fiducial to tracking the component according to a second fiducial. Thus, the trial femoral component is mounted on an impactor to which is attached a fiducial 14. The trial component is installed and positioned using the impactor. The computer 18 “knows” the position and orientation of the trial relative to the fiducial on the impactor (such as by prior registration of the component attached to the impactor) so that it can generate and display the image of the femoral component trial on screen 24 overlaid on the fluoroscopic image of the condylar component. At any desired point in time, before, during or after the trial component is properly placed on the condylar component of the femur to align with mechanical axis and according to proper orientation relative to other axes, the system can be instructed by foot pedal or otherwise to begin tracking the position of the trial component using the fiducial attached to the femur rather than the one attached to the impactor. According to the preferred embodiment, the sensor 16 “sees” at this point in time both the fiducials on the impactor and the femur 12 so that it already “knows” the position and orientation of the trial component relative to the fiducial on the impactor and is thus able to calculate and store for later use the position and orientation of the trial component relative to the femur 12 fiducial. Once this “handoff” happens, the impactor can be removed and the trial component tracked with the femur fiducial 14 as part of or moving in concert with the femur 12. Similar handoff procedures may be used in any other instance as desired in accordance with the present invention. Alternatively, the tibial trial can 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 is placed onto each feature, the system is prompted to save that coordinate position so that the system can match the tibial trial's feature's coordinates to the saved coordinates. The system 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 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 can also display how the soft tissue releases are to be made. During this assessment, the surgeon may conduct certain assessment processes such as external/internal rotation or rotary laxity testing, varus/valgus tests, and anterior-posterior drawer at 0 and 90 degrees and mid range. Thus, in the AP drawer test, the surgeon can position the tibia at the first location and press the foot pedal. He then positions the tibia at the second location and once again presses the foot pedal so that the computer has registered and stored two locations in order to calculate and display the drawer and whether it is acceptable for the patient and the product involved. If not, the computer can apply rules in order to generate and display suggestions for releasing ligaments or other tissue, or using other component sizes or types. Once the proper tissue releases have been made, if necessary, and alignment and stability are acceptable as noted quantitatively on screen about all axes, the trial components may be removed and actual components navigated, installed, and assessed in performance in a manner similar to that in which the trial components were navigated, installed, and assessed. 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 resectioning has been done on the bone. The system is also capable of tracking the patella and resulting placement of cutting guides and the patellar trial position. The system 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 systems and processes according to the present invention facilitate telemedical techniques, because they provide useful images for distribution to distant geographic locations where expert surgical or medical specialists may collaborate during surgery. Thus, systems and processes according to the present invention can be used in connection with computing functionality 18 which is networked or otherwise in communication with computing functionality in other locations, whether by PSTN, information exchange infrastructures such as packet switched networks including the Internet, or as otherwise desire. 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 produced in accordance with the present invention. 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. Referenced byCiting PatentFiling datePublication dateApplicantTitleUS8702712Dec 8, 2008Apr 22, 2014Smith & Nephew, Inc.Systems and methods for determining the mechanical axis of a femurUS8794977Apr 29, 2010Aug 5, 2014Lifemodeler, Inc.Implant training systemUS20050021037 *May 28, 2004Jan 27, 2005Mccombs Daniel L.Image-guided navigated precision reamersUS20110275957 *May 6, 2010Nov 10, 2011Sachin BhandariInertial Sensor Based Surgical Navigation System for Knee Replacement SurgeryUS20130150863 *Jun 14, 2012Jun 13, 2013Adrian BaumgartnerUltrasound ct registration for positioningWO2009076296A2 *Dec 8, 2008Jun 18, 2009Smith & Nephew IncSystems and methods for determining the mechanical axis of a femur* Cited by examinerClassifications U.S. Classification606/130International ClassificationA61F2/38, A61F2/46, A61F2/30, A61B19/00Cooperative ClassificationA61B2019/5272, A61B2019/566, A61B2019/502, A61B19/50, A61B19/20, A61B19/5244, A61F2002/3895, A61B2019/5416, A61F2/4684, A61B2019/505, A61F2002/30892, A61F2/389, A61B2017/00725, A61F2/461, A61B2019/5268, A61B2019/508, A61F2/38, A61F2002/30616, A61F2002/4632, A61B19/52, A61B2019/562, A61B2019/5255, A61F2/4657, A61F2/3859, A61B2019/5483, A61B2019/564, A61B19/56European ClassificationA61B19/52, A61B19/52H12, A61B19/20, A61F2/46B6RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services