Patent Grant
7542791
The present invention generally relates to planning and performing a selected procedure, and more particularly relates to preoperative planning of a procedure using various techniques and navigation to ensure that the preoperative plan is performed.
Image guided medical and surgical procedures utilize patient images obtained prior to or during a medical procedure to guide a physician performing the procedure. Recent advances in imaging technology, especially in imaging technologies that produce highly-detailed, computer-generated two, three and four-dimensional images, such as computed tomography (CT), magnetic resonance imaging (MRI), isocentric C-arm fluoroscopic imaging, fluoroscopes or ultrasounds have increased the interest in image guided medical procedures. During these image guided medical procedures, the area of interest of the patient that has been imaged is displayed on a display. Surgical instruments and/or implants that are used during this medical procedure are tracked and superimposed onto this display to show the location of the surgical instrument relative to the area of interest in the body. Other types of navigation systems operate as an image-less system, where an image of the body is not captured by an imaging device prior to the medical procedure, such as the device disclosed in U.S. patent application Ser. No. 10/687,539, entitled Method And Apparatus For Surgical Navigation Of A Multiple Piece Construct For Implantation, filed Oct. 16, 2003, incorporated herein by reference. With this type of procedure, the system may use a probe to contact certain landmarks in the body, such as landmarks on bone, where the system generates either a two-dimensional or three-dimensional model of the area of interest based upon these contacts. This way, when the surgical instrument or other object is tracked relative to this area, they can be superimposed on this model.
Most types of orthopedic medical procedures are performed using conventional surgical techniques, such as spine, hip, knee, shoulder, a synovial joint, and a facet joint. These techniques generally involve opening the patient in a relatively invasive manner to provide adequate viewing by the surgeon during the medical procedure. These types of procedures, however, generally extend the recovery period for the patient due to the extent of soft tissue and muscular incisions resulting from the medical procedure. Use of image guided technology in orthopedic medical procedures would enable a more minimally invasive type of procedure to be performed to thereby reduce the overall recovery time and cost of the procedure. Use of the image guided procedure may also enable more precise and accurate placement of an implant within the patient.
Once the implant has been surgically positioned within the patient, the patient's surrounding anatomy generally heals over time with the surrounding skeletal and muscular structure regaining a healthy state. However, since the implant is generally implanted when the patient is dysfunctional, this muscular and skeletal adjustment or healing may effect the subsequent range of motion, effectiveness, life expectancy of the implant, performance of the implant, and potentially cause deterioration of surrounding bones, discs, vertebrae, hips, knees, etc., or implants. For example, in a spinal implant, upon the abdominal and back muscles strengthening after the implant procedure, the spine may subsequently align. This alignment may result in the implant or articulation faces of the implant being impinged because of the resultant alignment. This may result in a revision-type surgery that requires the implant to be removed and a subsequent implant being repositioned at the implant site.
The surgical procedures performed during orthopedic medical procedures, including spinal procedures, require the use of various instruments, assemblies and jigs to perform the procedure. Typically, jigs are used to support a single instrument that must be attached to the area of interest when the instrument is being used. Multiple jigs are thus typically required to be attached and removed from the area of interest as the procedure progresses. Use of multiple jigs and instruments, along with attaching and reattaching to the area of interest provides for a tedious and time consuming procedure. Moreover, inherent inaccuracies due to this procedure may provide less than acceptable results.
It is, therefore, desirable to provide a method and apparatus for post-operative adjustment or tuning of an implant, such as a spinal implant using telemetric or minimally invasive techniques. It is also desirable to provide an instrument assembly that may be attached to the implant site, such as a spinal implant site, once during the entire procedure, thereby reducing surgical time, costs, as well as increasing surgical accuracy. It is further desirable to provide a system and apparatus that assist in precise preoperative planning and intraoperative navigation to position a selected implant. For example, it may be desirable to substantially determine a concise size, shape, volume, etc. of a implant prior to performing a procedure to ensure that the procedure will achieve a selected result. In addition, it is desirable to provide a system that will allow for substantially precise placement and performing of a procedure.
A system may be used for both preoperative planning and navigation during an operative procedure. Preoperative planning may be used to plan and confirm a selected procedure and select an implant for performing the procedure. For example, though not intended to be limiting, a selected disc or nucleus implant may be selected depending upon an image acquired of a patient and various measurements, such as size, shape, volume, location in the spine, (cervical, thoracic, lumbar), range of motion, and others, relating to the disc or nucleus to be replaced. Various other procedures may be performed with the system, such as knee implant selection, a thermal hip stem selection and others. In addition, the system may be used to navigate and perform the procedure to ensure that the selected plan is followed to achieve a result.
According to various embodiments a surgical system for a procedure pertaining to an anatomy is disclosed. The system includes an imaging device to obtain an image of a selected portion of the anatomy. A planning system may also be provided that includes a processor to execute operations relating to the image. The imaging device is operable to image the selected portion of the anatomy prior to the procedure. The processor is operable to determine a selected dimension in the image from the imaging device.
According to various embodiments, a method of performing a procedure to position a prosthesis in a selected portion of an anatomy is disclosed. The method includes acquiring an image of the selected portion of the anatomy and forming a model of the selected portion of the anatomy. A dimension of the model may be measured and a prosthesis may be selected based upon the measurement.
According to various embodiments a method of planning a procedure to implant a prosthetic into a portion of an anatomy includes selecting the portion of the anatomy. A model may be formed of the selected portion of the anatomy that is manipulable with a workstation. A procedure may be selected to be performed on the selected portion of the anatomy and a prosthetic may be selected to be implanted during the procedure.
According to various embodiments a surgical system operable to obtain image data for a procedure pertaining to a selected portion of an anatomy is disclosed. The system includes a planning system having a processor to execute operations relating to the image data. The image data relates to the selected portion of the anatomy prior to the procedure. The planning system is also operable to determine a selected dimension of the selected portion of the anatomy from the image data.
According to various embodiments a method of performing a procedure to position a prosthesis in a selected portion of an anatomy includes acquiring image data of the selected portion of the anatomy. A dimension of the anatomical portion may be measured and a prosthesis may be selected based at least in part of the measurement.
According to various embodiments a surgical system for a procedure pertaining to an anatomy is disclosed. The system may include an imaging device to obtain image data of a selected portion of a spine of the anatomy The system may further include a planning system including a processor to execute operations relating to the image data. The imaging device may generate image data of the selected portion of the anatomy prior to the procedure. The processor may determine a selected dimension in the image data from the imaging device. An implant may be positioned relative to the selected portion of the spine based on the selected dimension.
According to various embodiments a method of performing a procedure to position a prosthesis in a selected portion of a spinal region is disclosed. The method includes acquiring image data of the selected portion of the spinal region and measuring an anatomical dimension of the selected portion of the anatomy with the acquired image data. A prosthesis may be selected based upon the measurement.
Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:
a and 2b are diagrams representing undistorted and distorted views of a fluoroscopic C-arm imaging device;
a and 3b is a logic block diagram illustrating a method for employing the display according to the teachings of the present invention;
a-4e illustrate a medical procedure employing the display according to the teachings of the present invention;
a-8g illustrate another medical procedure employing the display according to the teachings of the present invention;
a-16c are an unfolded and partially folded view of other embodiment of a cervical disc implant according to the teachings of the present invention;
The following description of embodiments is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. Moreover, while the invention is discussed in detail below in regard to orthopedic/spinal surgical procedures, the present invention may be used with any type of medical procedure, including orthopedic, cardiovascular, neurovascular, soft tissue procedures, or any other medical procedures.
The navigation system 12 includes an imaging device 16 that is used to acquire pre-operative or real-time images of the patient 14. The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22, an optional calibration and tracking target 24 and optional radiation sensors 26. The optional calibration and tracking target 24 includes calibration markers 28 (see
A controller 30 captures the x-ray images received at the receiving section 22 and stores the images for later use. If a C-arm configuration is used to hold and/or move the imaging system 16, the controller 30 may also control the rotation of the C-arm 18, including the imaging system 16. For example, the C-arm 18 may move in the direction of arrow 32 or rotate about the long axis of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged. Each of these movements involve rotation about a mechanical axis 34 of the C-arm 18. In this example, the long axis of the patient 14 is substantially in line with an axis of motion 34 of the C-arm 18. This enables the C-arm 18 to be moved relative to the patient 14, allowing images of the patient 14 to be taken from multiple directions or about multiple planes. An example of a fluoroscopic x-ray imaging device 16 is the “Series 9600 Mobile Digital Imaging System,” from OEC Medical Systems, Inc., of Salt Lake City, Utah. Other exemplary fluoroscopes include bi-plane fluoroscopic systems, ceiling fluoroscopic systems, cath-lab fluoroscopic systems, fixed C-arm configuration fluoroscopic systems, etc.
In operation, the imaging device 16 generates x-rays from the x-ray source 20 that propagate through the patient 14 and calibration and/or tracking target 24, into the x-ray receiving section 22. The receiving section 22 generates an image representing the intensities of the received x-rays. Typically, the receiving section 22 includes an image intensifier that first converts the x-rays to visible light and a charge coupled device (CCD) video camera that converts the visible light into digital images. Receiving section 22 may also be a digital device that converts x-rays directly to digital images, thus potentially avoiding distortion introduced by first converting to visible light. With this type of digital imaging device, which is generally a flat panel device, the calibration and/or tracking target 24 and the calibration process discussed below may be eliminated. Also, the calibration process may be eliminated for different types of medical procedures. Alternatively, the imaging device 16 may only take a single image with the calibration and tracking target 24 in place. Thereafter, the calibration and tracking target 24 may be removed from the line-of-sight of the imaging device 16.
Two dimensional fluoroscopic images taken by the imaging device 16 are captured and stored in the controller 30. These images are forwarded from the controller 30 to a controller or work station 36 having the display 10 that may either include a single display 10 or a dual display 10 and a user interface 38. The work station 36 provides facilities for displaying on the display 10, saving, digitally manipulating, or printing a hard copy of the received images, as well as the five or six degree of freedom display. The user interface 38, which may be a keyboard, joy stick, mouse, touch pen, touch screen or other suitable device allows a physician or user to provide inputs to control the imaging device 16, via the controller 30, or adjust the display settings, such as safe zones of the display 10, further discussed herein. The work station 36 may also direct the controller 30 to adjust the rotational axis 34 of the C-arm 18 to obtain various two-dimensional images along different planes in order to generate representative two-dimensional and three-dimensional images. When the x-ray source 20 generates the x-rays that propagate to the x-ray receiving section 22, the radiation sensors 26 sense the presence of radiation, which is forwarded to the controller 30, to identify whether or not the imaging device 16 is actively imaging. This information is also transmitted to a coil array controller 48, further discussed herein. Alternatively, a person or physician may manually indicate when the imaging device 16 is actively imaging or this function can be built into the x-ray source 20, x-ray receiving section 22, or the control computer 30.
Fluoroscopic imaging devices 16 that do not include a digital receiving section 22 generally require the calibration and/or tracking target 24. This is because the raw images generated by the receiving section 22 tend to suffer from undesirable distortion caused by a number of factors, including inherent image distortion in the image intensifier and external electromagnetic fields. An empty undistorted or ideal image and an empty distorted image are shown in
Intrinsic calibration, which is the process of correcting image distortion in a received image and establishing the projective transformation for that image, involves placing the calibration markers 28 in the path of the x-ray, where the calibration markers 28 are opaque or semi-opaque to the x-rays. The calibration markers 28 are rigidly arranged in pre-determined patterns in one or more planes in the path of the x-rays and are visible in the recorded images. Because the true relative position of the calibration markers 28 in the recorded images are known, the controller 30 or the work station or computer 36 is able to calculate an amount of distortion at each pixel in the image (where a pixel is a single point in the image). Accordingly, the computer or work station 36 can digitally compensate for the distortion in the image and generate a distortion-free or at least a distortion improved image 40 (see
While the fluoroscopic imaging device 16 is shown in
The navigation system 12 further includes an electromagnetic navigation or tracking system 44 that includes a transmitter coil array 46, the coil array controller 48, a navigation probe interface 50, an instrument 52 having an electromagnetic tracker and a dynamic reference frame 54. It should further be noted that the entire tracking system 44 or parts of the tracking system 44 may be incorporated into the imaging device 16, including the work station 36 and radiation sensors 26. Incorporating the tracking system 44 will provide an integrated imaging and tracking system. Any combination of these components may also be incorporated into the imaging system 16, which again can include a fluoroscopic C-arm imaging device or any other appropriate imaging device. Obviously, if an image-less procedure is performed, the navigation and tracking system 44 will be a stand alone unit.
The transmitter coil array 46 is shown attached to the receiving section 22 of the C-arm 18. However, it should be noted that the transmitter coil array 46 may also be positioned at any other location as well, particularly if the imaging device 16 is not employed. For example, the transmitter coil array 46 may be positioned at the x-ray source 20, within the OR table 56 positioned below the patient 14, on siderails associated with the OR table 56, or positioned on the patient 14 in proximity to the region being navigated, such as by the patient's pelvic area. The transmitter coil array 46 includes a plurality of coils that are each operable to generate distinct electromagnetic fields into the navigation region of the patient 14, which is sometimes referred to as patient space. Representative electromagnetic systems are set forth in U.S. Pat. No. 5,913,820, entitled “Position Location System,” issued Jun. 22, 1999 and U.S. Pat. No. 5,592,939, entitled “Method and System for Navigating a Catheter Probe,” issued Jan. 14, 1997, each of which are hereby incorporated by reference.
The transmitter coil array 46 is controlled or driven by the coil array controller 48. The coil array controller 48 drives each coil in the transmitter coil array 46 in a time division multiplex or a frequency division multiplex manner. In this regard, each coil may be driven separately at a distinct time or all of the coils may be driven simultaneously with each being driven by a different frequency. Upon driving the coils in the transmitter coil array 46 with the coil array controller 48, electromagnetic fields are generated within the patient 14 in the area where the medical procedure is being performed, which is again sometimes referred to as patient space. The electromagnetic fields generated in the patient space induces currents in sensors 58 positioned in the instrument 52, further discussed herein. These induced signals from the instrument 52 are delivered to the navigation probe interface 50 and subsequently forwarded to the coil array controller 48. The navigation probe interface 50 provides all the necessary electrical isolation for the navigation system 12. The navigation probe interface 50 also includes amplifiers, filters and buffers required to directly interface with the sensors 58 in instrument 52. Alternatively, the instrument 52 may employ a wireless communications channel as opposed to being coupled directly to the navigation probe interface 50.
The instrument 52 is equipped with at least one, and may include multiple localization sensors 58. In this regard, the instrument 52 may include an orthogonal pair coil sensor 58 or a tri-axial coil sensor 58 or multiple single coil sensors 58 positioned about the instrument 52. Here again, the instrument 52 may be any type of medical instrument or implant. For example, the instrument may be a catheter that can be used to deploy a medical lead, be used for tissue ablation, or be used to deliver a pharmaceutical agent. The instrument 52 may also be an orthopedic instrument, used for an orthopedic procedure, such as reamers, impactors, cutting blocks, saw blades, drills, drill guides, distracters, awls, taps, probes, screw drivers, etc. The instrument 52 may also be any type of neurovascular instrument, cardiovascular instrument, soft tissue instrument, etc. Finally, the instrument 52 may be an implant that is tracked, as well as any other type of device positioned and located within the patient 14. These implants can include orthopedic implants, neurovascular implants, cardiovascular implants, soft tissue implants, spinal implants, nucleus implants, cranial implants, or any other devices that are implanted into the patient 14. Particularly, implants that are formed from multiple components where the location and orientation of each component is dependent upon the location and orientation of the other component, such that each of these components can be tracked or navigated by the navigation and tracking system 44 to be displayed on the six degree of freedom display 10.
In an alternate embodiment, the electromagnetic sources or generators may be located within the instrument 52 and one or more receiver coils may be provided externally to the patient 14 forming a receiver coil array similar to the transmitter coil array 46. In this regard, the sensor coils 58 would generate electromagnetic fields, which would be received by the receiving coils in the receiving coil array similar to the transmitter coil array 46. Other types of localization or tracking may also be used with other types of navigation systems, which may include an emitter, which emits energy, such as light, sound, or electromagnetic radiation, and a receiver that detects the energy at a position away from the emitter. This change in energy, from the emitter to the receiver, is used to determine the location of the receiver relative to the emitter. These types of localization systems include conductive, active optical, passive optical, ultrasound, sonic, electromagnetic, etc. An additional representative alternative localization and tracking system is set forth in U.S. Pat. No. 5,983,126, entitled “Catheter Location System and Method,” issued Nov. 9, 1999, which is hereby incorporated by reference. Alternatively, the localization system may be a hybrid system that includes components from various systems.
The dynamic reference frame 54 of the electromagnetic tracking system 44 is also coupled to the navigation probe interface 50 to forward the information to the coil array controller 48. The dynamic reference frame 54 is a small magnetic field detector or any other type of detector/transmitter that is designed to be fixed to the patient 14 adjacent to the region being navigated so that any movement of the patient 14 is detected as relative motion between the transmitter coil array 46 and the dynamic reference frame 54. This relative motion is forwarded to the coil array controller 48, which updates registration correlation and maintains accurate navigation, further discussed herein. The dynamic reference frame 54 can be configured as a pair of orthogonally oriented coils, each having the same center or may be configured in any other non-coaxial coil configuration. The dynamic reference frame 54 may be affixed externally to the patient 14, adjacent to the region of navigation, such as the patient's spinal region, as shown in
Alternatively, the dynamic reference frame 54 may be internally attached, for example, to the spine or vertebrae of the patient using bone screws that are attached directly to the bone. This provides increased accuracy since this will track any motion of the bone. Moreover, multiple dynamic reference frames 54 may also be employed to track the position of two bones relative to a joint. For example, one dynamic reference frame 54 may be attached to a first vertebra, while a second dynamic reference frame 54 may be attached to a second vertebra. In this way, motion of the spine or vertebrae may be detected by the dual dynamic reference frames 54. An exemplary dynamic reference frame 54 and fiducial marker 60, is set forth in U.S. Pat. No. 6,381,485, entitled “Registration of Human Anatomy Integrated for Electromagnetic Localization,” issued Apr. 30, 2002, which is hereby incorporated by reference.
The dynamic reference frame 54 may be affixed or connected to the vertebrae in any appropriate manner. For example a pin or rod may interconnect the dynamic reference frame 54 and the vertebrae. Other mechanisms may be provided to reduce rotation, such as teeth or barbs that extend from the rod and further engage the vertebrae that reduce rotation of the rod and the dynamic reference frame 54. Various exemplary systems are disclosed in U.S. Pat. Nos. 6,226,548 and 6,203,543, each incorporated herein by reference. This may allow the dynamic reference frame 54 to be attached to the vertebrae substantially percutaneously.
Also the workstation 38, or any appropriate portion of the system, may provide for a check of the placement of the dynamic reference frame in the image space. For example, unintended rotational or other movement may occur. The system, including software, may be used to determine that at least one of the dynamic reference frames 54 have moved. During a cycle of the software, or any other appropriate time, the system may check to ensure that the dynamic reference frame 54 is in a selected location. If it is not the user may re-register the patient 14. Alternatively a second dynamic reference frame, of known movement and relative location to the first dynamic reference frame, may be used to re-register or correlate the inadvertent movement of the first dynamic reference frame.
Regardless, the system may be able to determine that the dynamic reference frame is in a location other than a selected or known location. For example, the system may determine that the dynamic reference frame may have moved an amount greater than expected or a direction, such as rotation about its axis of fixation to the patient, other than one expected. The system, including the workstation 38, may then provide an alert, such as an audible or visual alert, to a user that the unexpected movement has occurred. The user can then re-register the patient 14 or an autonomous re-registration may be completed with the workstation 38.
Briefly, the navigation system 12 operates as follows. The navigation system 12 creates a translation map between all points in the radiological image generated from the imaging device 16 and the corresponding points in the patient's anatomy in patient space. After this map is established, whenever a tracked instrument 52 is used, the work station 36 in combination with the coil array controller 48 and the controller 30 uses the translation map to identify the corresponding point on the pre-acquired image, which is displayed on display 10. This identification is known as navigation or localization. An icon representing the localized point or instrument is shown on the display 10, along with five or six degrees of freedom indicia.
In addition, the dynamic reference frame 54 may include coils that are tracked with an electromagnetic (EM) tracking system. In such a system the dynamic reference frame may include a plurality of coils placed in a known geometry and distance from each other. Then, during a use of the dynamic reference frame 54 the system may determine whether interference is obscuring a true measurement of the dynamic reference frame 54. For example, a metal object may create eddy current induced in the EM coils. Thus the system may both determine a location of the dynamic reference frame 54 and the relative location of each of the plurality of EM coils in the dynamic reference frame 54. The system can then compare the relative sensed location and/or placement of the EM coils to the known geometry of the coils and select the most appropriate coil that is providing the signal. For example, if three coil are placed at a selected angle, such as 120 degrees, and a known distance, such as 2 mm, from the others this known information can be used to determine which coil is the least interfered. That is the coil that sensed most precisely relative to the other known coils is the coil that is more precise in that field.
To enable navigation, the navigation system 12 will detect both the position of the patient's anatomy 14 and the position of the surgical instrument 52. Knowing the location of these two items allows the navigation system 12 to compute and display the position of the instrument 52 in relation to the patient 14. The tracking system 44 is employed to track the instrument 52 and the anatomy simultaneously. While the display 10 is configured to show the instrument with six degree of freedom accuracy.
The tracking system 44 essentially works by positioning the transmitter coil array 46 adjacent to the patient space to generate a low-energy magnetic field generally referred to as a navigation field. Because every point in the navigation field or patient space is associated with a unique field strength, the electromagnetic tracking system 44 can determine the position of the instrument 52 by measuring the field strength at the sensor 58 location. The dynamic reference frame 54 is fixed to the patient 14 to identify the location of the patient 14 in the navigation field. The electromagnetic tracking system 44 continuously recomputes the relative position of the dynamic reference frame 54 and the instrument 52 during localization and relates this spatial information to patient registration data to enable image guidance of the instrument 52 within the patient 14.
Patient registration is the process of determining how to correlate the position of the instrument 52 on the patient 14 to the position on the diagnostic, pre-acquired, or real-time images. To register the patient 14, the physician or user will select and store particular points from the pre-acquired images and then touch the corresponding points on the patient's anatomy with a pointer probe 62. The navigation system 12 analyzes the relationship between the two sets of points that are selected and computes a match, which correlates every point in the image data with its corresponding point on the patient's anatomy or the patient space. The points that are selected to perform registration are the fiducial arrays or landmarks 60. Again, the landmarks or fiducial points 60 are identifiable on the images and identifiable and accessible on the patient 14. The landmarks 60 can be artificial landmarks 60 that are positioned on the patient 14 or anatomical landmarks 60 that can be easily identified in the image data. Other types of registration may be point registration, contour surface registration, isocentric registration, automatic registration, and any other appropriate system or method of registering a patient space to an image space. The system 12, such as the system disclosed in U.S. patent application Ser. No. 10/644,680, entitled Method and Apparatus for Performing 2D to 3D Registration, filed Aug. 20, 2003, incorporated herein by reference, may also perform 2D to 3D registration by utilizing the acquired 2D images to register 3D volume images by use of contour algorithms, point algorithms, normalized mutual information, pattern intensity, or density comparison algorithms, as is known in the art.
In order to maintain registration accuracy, the navigation system 12 continuously tracks the position of the patient 14 during registration and navigation. This is necessary because the patient 14, dynamic reference frame 54, and transmitter coil array 46 may all move during the procedure, even when this movement is not desired. Therefore, if the navigation system 12 did not track the position of the patient 14 or area of the anatomy, any patient movement after image acquisition would result in inaccurate navigation within that image. The dynamic reference frame 54 allows the electromagnetic tracking device 44 to register and track the anatomy. Because the dynamic reference frame 54 is rigidly fixed to the patient 14, any movement of the anatomy or the transmitter coil array 46 is detected as the relative motion between the transmitter coil array 46 and the dynamic reference frame 54. This relative motion is communicated to the coil array controller 48, via the navigation probe interface 50, which updates the registration correlation to thereby maintain accurate navigation.
It should also be understood that localization and registration data may be specific to multiple targets. For example, should a spinal procedure be conducted, each vertebra may be independently tracked and the corresponding image registered to each vertebra. In other words, each vertebra would have its own translation map between all points in the radiological image and the corresponding points in the patient's anatomy in patient space in order to provide a coordinate system for each vertebra being tracked. The tracking system 44 would track any motion in each vertebra by use of a tracking sensor 58 associated with each vertebra. In this way, dual displays 10 may be utilized, further discussed herein, where each display tracks a corresponding vertebra using its corresponding translation map and a surgical implant or instrument 52 may be registered to each vertebra and displayed on the display 10 further assisting an alignment of an implant relative to two articulating or movable bones. Moreover, each separate display in the dual display 10 may superimpose the other vertebra so that it is positioned adjacent to the tracked vertebra thereby adding a further level of information on the six degree of freedom display 10.
As an alternative to using the imaging system 16, in combination with the navigation and tracking system 44, the five or six degree of freedom alignment display 10 can be used in an imageless manner without the imaging system 16. In this regard, the navigation and tracking system 44 may only be employed and the probe 62 may be used to contact or engage various landmarks on the patient. These landmarks can be bony landmarks on the patient, such that upon contacting a number of landmarks for each bone, the workstation 36 can generate a three-dimensional model of the bones. This model is generated based upon the contacts and/or use of atlas maps. The workstation 36 may also generate a center axis of rotation for the joint or planes, based upon the probe contacts. Alternatively, the tracking sensor 58 may be placed on the patient's anatomy and the anatomy moved and correspondingly tracked by the tracking system 44. For example, placing a tracking sensor 58 on the femur and fixing the pelvis in place of a patient and rotating the leg while it is tracked with the tracking system 44 enables the work station 36 to generate a center of axis of the hip joint by use of kinematics and motion analysis algorithms, as is known in the art. If the pelvis is not fixed, another tracking sensor 58 may be placed on the pelvis to identify the center of axis of the hip joint. If a tracking sensor 58 is placed on the femur and a tracking sensor 58 is placed on the tibia, upon moving this portion of the anatomy, a center of axis of the knee joint may be identified. Likewise, by placing a separate tracking sensor 58 on two adjacent vertebra and articulating the spine, the center of axis of the spinal region can also be identified. In this way, a target and/or model based on the center of the particular joint may be designated and identified on the six degree of freedom display 10. Movement of the instrument or implant 52 may then be tracked in relation to this target and/or model to properly align the instrument or implant 52 relative to the target and/or model.
Turning to
If an image-less medical procedure is selected, the method begins at block 72 identifying that an image-less based medical procedure will be performed. This method proceeds to either block 74 identifying a first way to generate image-less models or block 76 identifying a second way to generate image-less models. At block 74, the probe 62 is used to contact the body at various anatomical landmarks in the area of interest, such as a bone. For example, by touching the probe 62 to the pelvis, knee, ankle, and spine, articulation planes can be defined using known algorithms and the center of each joint may also be defined. An example of this type of modeling is set forth in U.S. Pat. No. 5,682,886, which is hereby incorporated by reference. Alternatively, multiple anatomical landmarks can be contacted with the probe 62 to generate a 3-D model with the more points contacted, the more accurate the model depicted.
Secondly, to generate a model at block 76, a tracking device is placed on the body and the body rotated about the joint. When this is done, the plane of rotation and joint center can be identified using known kinematic and/or motion analysis algorithms or using atlas maps or tables, as is known in the art. Once the area of interest has been probed, via block 74 or block 76, a model is generated at block 78. This model can be a 3-D surface rendered model, a 2-D model identifying articulating planes or a 3-D model identifying articulating planes and rotation, as well as the center of the joints. This enables the display 10 to use the joint centers or articulating planes as the target or trajectory, further discussed herein.
With each of the procedures 74 or 76, the procedure may be initially based on the use of atlas information or a 3-D model that is morphed, to be a patient specific model. In this regard, should the femur be the area of interest, an accurate representation of an ordinary femur may be selected from an atlas map, thereby providing an initial 2-D or 3-D model representing a typical anatomical femur. As with block 74, upon contacting numerous areas on the actual femur with the probe 62, the atlas model may be morphed into a patient specific 3-D model, with the more points contacted, the more accurate the morphed model. Patient specific information may also be acquired using an ultrasound probe to again identify the shape of the patient's natural femur in order to morph the atlas model. A fluoroscopic image of the region may also be used to morph the patient's femur with the atlas model to provide a patient specific morphed model. Proceeding under block 76 and assuming that the area of interest is the hip joint, an atlas model of the femur and pelvis may be the initial starting point. Upon rotating and moving the femur relative to the pelvis, a patient specific morphed model may be created to generate accurate joint centers and axes of motion again using known kinematics and/or motion analysis algorithms
Once the image data is calibrated and registered at block 70 or the model is generated at block 78, the method proceeds to block 80. At block 80, the specific type of coordinate system is selected, which will be displayed by indicia on the six degree of freedom display 10. The coordinate systems can be a Cartesian coordinate system, a spherical coordinate system, or a polar coordinate system. By way of example, the Cartesian coordinate system will be selected. The Cartesian coordinate system will include the X, Y, and Z axes, and X rotation, Y rotation, and Z rotation about its respective axes.
With reference to
Arrow indicator 94 identifies the degree of rotation about the X axis 82. Arrow indicator 96 shows the amount of rotation about the Y axis 84. Arrow 98 identifies the rotation about the Z axis, while arrow 100 identifies the depth being tracked along the Z axis 86. The origin 102 may be set to be the desired target position or trajectory path. The crosshairs 104 represents the tip of the instrument 52 being tracked, while the circle 106 represents the hind area of the instrument 52 being tracked. With the understanding that the instrument 52 can be any type of medical device or implant. Also, if five degree of freedom information is provided, one of the indicia 82, 84, 86, 88, 90, and 92 will be removed.
Once the coordinate system is selected at block 80, the method proceeds to block 108 where the target or trajectory is selected. The target or trajectory selected at block 108 is typically positioned at the origin 102 on the display 10. In this way, the object being tracked or aligned may be tracked and aligned about the origin 102. Alternatively, the target may be identified at any coordinate within the display 10 or multiple targets may also be identified within the single display 10. An indicia of the target may also be positioned on the display 10. The target is selected based upon the desired area to position the instrument 52 and can be selected from the pre-acquired images or from the 3-D model. Once selected, this target is correlated to the display 10 and generally positioned at the origin 102.
Once the target/trajectory is selected at block 108, such as the origin 102, the method proceeds to block 110 where the safe zones are identified for each degree of freedom. Referring again to
Once the safe zones 112 are identified for each degree of freedom in block 110, the method proceeds to block 114 where the target trajectory in the selected coordinate system is displayed with the safe zones 112, as shown in
Once the target/trajectory 102 is displayed along with the safe zones 112 in the proper coordinate system, as shown in
With the indicia of the implant/instrument 52 being displayed, the implant/instrument 52 is aligned or fixed with the target/trajectory 102 at block 124. In this regard, the tip 104 and the hind 106 are aligned and fixed relative to the target/trajectory 102 at the origin and the rotational orientation is also aligned to the desired position. Again, the target/trajectory 102 may not be positioned at the origin and can be positioned anywhere within the coordinate system if desired. As shown in
At block 126, a determination is made as to whether there is a second implant/instrument 52 to be tracked. If there is not a second implant/instrument 52 to be tracked, the method ends at block 128. Should there be a second implant/instrument 52 to track, such as a corresponding implant component that articulates with the first implant, the method proceeds to block 130. At block 130, a second target/trajectory 102 is selected, which is based upon the alignment or fixation of the first implant/instrument 52 relative to the first target/trajectory 102. In this regard, if the surgeon is not able to position the first implant/instrument 52 at the desired target/trajectory 102, this offset from the target/trajectory 102 may affect the second implant, which possibly articulates or mates with the first implant. If this is the case, the second target/trajectory 102 will need to take into consideration this offset in order to provide proper articulation and alignment of the first implant component with the second implant component.
With minimally invasive types of procedures, the implant may also have numerous components with each component articulating or mating with another component, thereby requiring tracking of each component as it is implanted during the minimally invasive procedure. This second target/trajectory 102 may be displayed on a separate display 10 (see
Once the second target/trajectory 102 has been selected at block 130, the method proceeds to block 132. At block 132, the safe zones 112 for each degree of freedom is selected for the second implant/instrument 52 similar to the way the first set of safe zones 112 were selected for the first implant/instrument 52. Once the second safe zones 112 are selected, the method proceeds to block 134. At block 134, the display 10 displays the second target/trajectory 102 in the same coordinate system with the second safe zones 112. Here again, at block 136, if it is an image based medical procedure, the pre-acquired image may be superimposed on to the target/trajectory 102. Alternatively, this image can be positioned adjacent the target screen in a split screen configuration (see
Alternatively, separate displays 10 may be used where information is linked between the displays showing the second implant/instrument 52 in relation to the first implant/instrument 52. With the second implant/instrument 52 being tracked at block 140, the second implant/instrument 52 is displayed in relation to the second target/trajectory 102 in five or six degrees of freedom at block 142. Again, this may be a separate display 10, a split screen display 10 with both the first target/trajectory 102 and the second target/trajectory 102 or the same display 10 displaying both targets/trajectories 102. While the second implant/instrument 52 is being displayed, the second implant/instrument 52 is aligned and fixed at the second target/trajectory 102 at block 144. Once the second implant/instrument 52 is fixed at block 144, the method proceeds to block 146.
At block 146, a determination is made whether the alignment or fixation of the first and second implants/instruments 52 are correct. In this regard, with two separate displays 10 linked or with a single display 10, showing both targets/trajectories 102, a surgeon can determine whether each implant/instrument 52 is within its desired safe zones 112 and, therefore, optimally positioned for proper articulation. Here again, these safe zones 112 may be color coded for the different safe zones provided. If both implants are positioned and fixed at the proper targets, the method ends at block 148. If one or both of the implants are not properly positioned, adjustment of the first or second target/trajectory 102 is performed at block 150. Once either or both targets are adjusted, realignment of the first and/or second implants/instruments 52 are performed at block 152. Here again, since multiple component implants are dependent upon one another with respect to their position and orientation, alignment and adjustments of the targets/trajectories 102 may be performed several times until the optimum placement for each is performed at repeat block 154. Thereafter, the method terminates at end block 156.
While the above-identified procedure is discussed in relation to an orthopedic medical procedure in which an implant having multiple implant components is implanted within a patient using the six degree of freedom display 10, it should be noted that the six degree of freedom display 10 may be used to track other medical devices as well. For example, as was briefly discussed, an ablation catheter generally has an electrode positioned only on one angular portion of its circumference. Likewise, the wall of an artery typically has a larger plaque build-up on one side. Therefore, it is desirable to align that ablation electrode with the proper side of the artery wall during the procedure. With the six degree of freedom display 10, the surgeon can easily identify the location, depth and angular rotation of the catheter relative to the artery wall. Other types of procedures may require the medical instrument or probe to be properly oriented and located within the patient, such as identifying and tracking tumors, soft tissue, etc. By knowing and displaying the six degree of freedom movement of the medical device on the display 10, the medical procedure is optimized.
It should also be pointed out that the method discussed above requires that the implant/instrument 52 have a tracking sensor associated therewith in order to identify the location of the tracked device in six degrees of freedom and display it on the display 10. The tracking sensors may be attached directly to implants, attached to the instruments that engage the implants or attach to members extending out from the implants. These tracking sensors again may be electromagnetic tracking sensors, optical tracking sensors, acoustic tracking sensors, etc. Examples of various targets, which may or may not be superimposed on the display again include orthopedic targets, spinal targets, cardiovascular targets, neurovascular targets, soft tissue targets, etc. Specific examples include again the location of the plaque on a wall of an artery, the center of an articulating joint being replaced, the center of the implant placement, etc. By displaying two targets, either on separate displays or on the same display, the surgeon can dynamically plan and trial implant placements by moving one component of the implant to see where the other articulating component of the implant should be positioned. In this way, the surgeon can trial the implant confirming its placement and orientation, via the display 10 before the implant is permanently affixed to the patient 14.
In a spinal procedure, two adjacent vertebra bodies can be tracked and displayed on two separate displays. In this way, if a single jig, such as a cutting jig is used to cut both the surface of the first vertebra and the surface of the second vertebra, orientation of the jig may be displayed on each separate display in relation to the corresponding vertebra being acted upon, thereby enabling simultaneous tracking of the two planes being resected for each separate vertebra on a dual display system. It will be understood that the tracked planes can be aligned or intersect in any appropriate manner or by any appropriate mechanism. For example, the planes may intersect at a selected point, such that the planes are not substantially parallel. In addition, the planes can be selected by a user, a system, a jig, an implant, or any other appropriate mechanism. Therefore, it will be understood that while two planes may be tracked substantially simultaneously, they can be defined or oriented in any appropriate manner. Additionally, each vertebra may be displayed on each of the dual displays so that the vertebra being tracked is shown with the adjacent vertebra superimposed adjacent thereto. Once the vertebra bodies are prepared, the implant is typically placed between each vertebra on the prepared site. Other ways of preparing this site is by using drills, reamers, burrs, trephines or any other appropriate cutting or milling device.
Briefly, the method, as shown in
Tones, labels, colors, shading, overlaying with image data can all be modified and incorporated into the display 10. The current display 10 is also shown as a Cartesian coordinate based display, but again could be based on a polar based display or a spherical based display and a quick switch between both can be supplied or simultaneously displayed. The display can also be configured by the user to hide parameters, location, size, colors, labels, etc.
Some medical applications that may be commonly displayed and linked to the display 10 are: 1) reaming of an acetabular cup with major focus upon RY and RZ, 2) length of leg during hip and knee procedures focused upon TZ and RZ, 3) biopsies and ablations focused upon RX, RY, and RZ for direction of the therapy device, and 4) catheters with side ports for sensing information or delivery of devices, therapies, drugs, stem cells, etc. focused upon six degree of freedom information.
Referring now to
In this regard,
Turning to
Once the acetabular cup 178 has been impacted, the femoral head 162 is resected along a plane 184 by use of a cutting guide 186, having the tracking sensor 58 and a saw blade 188. By using the center of the femoral head 162 as the second target, the cutting plane 184 may be properly defined to provide proper articulation with the acetabular cup 178 before a hip stem is implanted in the femur 160. Here again, the second target is dependent upon the first target. Thus, if the acetabular cup 178 was implanted somewhat offset from its target, the second target may be properly compensated to accommodate for this offset by use of the display 10. In this regard, a second display illustrating the target for the cutting plane 184 may be provided.
Once the femoral head 162 of the femur 160 has been resected, as shown in
Once the intramedullary canal 192 has been reamed by the reamer 190, a hip stem 194 is impacted with an impactor 196 into the intramedullary canal 192. By targeting the acetabular cup location, along with the resection plane 184 and the reaming axis of the reamer 190, upon positioning the hip stem 194, within the femur 160, proper articulation and range of motion between the acetabular cup 178 and the hip stem 194 is achieved without time consuming trialing as is conducted in conventional orthopedic procedures. Thus, by providing the safe zones 112 in relation to the hip stem 194 size, proper articulation with the acetabular cup 178 is achieved. Here again, while an example of an orthopedic hip replacement is set out, the six degree of freedom display 10 may be utilized with any type of medical procedure requiring visualization of a medical device with six degree freedom information.
The six degree of freedom display 10 enables implants, devices and therapies that have a specific orientation relative to the patient anatomy 14 to be properly positioned by use of the display 10. As was noted, it is difficult to visualize the correct placement of devices that require five or six degree of freedom alignment. Also, the orientation of multiple-segment implants, devices, or therapies in five and six degrees of freedom so that they are placed or activated in the correct orientation to one another is achieved with the display 10. Since the location and orientation is dependent upon one another to be effective, by having the proper orientation, improved life of the implants, the proper degrees of motion, and patient outcome is enhanced. Also, the six degree of freedom display 10 may be used as a user input mechanism by way of keyboard 38 for controlling each degree of freedom of a surgical robotic device. In this regard, the user can input controls with the joystick, touch screen or keyboard 38 to control a robotic device. These devices also include drill guide holders, drill holders, mechanically adjusted or line devices, such as orthopedic cutting blocks, or can be used to control and drive the alignment of the imaging system 16, or any other type of imaging system.
Since multiple implants and therapies, or multi-segment/compartment implants require multiple alignments, the display 10 may include a stereo display or two displays 10. These displays may or may not be linked, depending on the certain procedure. The target point/location (translation and orientation of each implant component is dependent upon the other implant placement or location). Therefore, the adjustment or dynamic targeting of the dependent implant needs to be input to the dependent implant and visually displayed. Again, this can be done by two separate displays or by superimposing multiple targets on a single display. Many implants such as spinal disc implants, total knee and total hip replacements repair patient anatomy 14 by replacing the anatomy (bone, etc.) and restoring the patient 14 to the original biomechanics, size and kinematics. The benefit of the six degree of freedom alignment display 10 is that original patient data, such as the images can be entered, manually or collectively, via the imaging device 16 or image-less system used for placement of the implant. Again, manually, the user can enter data, overlay templates, or collect data, via the imaging system 16. An example, as discussed herein of an application is the alignment of a femoral neck of a hip implant in the previous patient alignment. The previous patient alignment can be acquired by landmarking the patient femoral head by using biomechanics to determine the center and alignment of the current line and angle of the femoral head. This information can be used as the target on the display 10 in order to properly align the implant replacing the femoral head.
The six degree of freedom display 10 also provides orientation guidance on a single display. Separate visual and quantitative read-outs for each degree of freedom is also displayed on the display 10. Visual representations or indicia of procedure-specific accepted values (i.e., a “safe zone 112”) for each degree of freedom is also clearly displayed on the display 10. These safe zones 112 are displayed as specifics or ranges for the user to align or place within. The procedure specific accepted values for the safe zones 112 can be manufacture determined, user determined, patient specific (calculated) or determined from algorithms (finite element analysis, kinematics, etc. atlas or tables). It can also be fixed or configurable. Safe zones 112 can also be defined as ranges around a planned trajectory path or the specific trajectory path itself (range zero). The trajectory paths are input as selected points by the user or paths defined from the patient image data (segmented vascular structure, calculated centers of bone/joints, anatomical path calculated by known computed methods, etc.).
Turning now to
Referring specifically to
Referring to
Once each vertebrae 200 and 202 have been distracted by the cam distracter 204, a sagittal wedge 206 also having a tracking sensor 58 is utilized and shown in
Once the sagittal centering has been achieved with the sagittal wedge 206, the medical procedure proceeds to burring as shown in
Referring to
Here again, the six degree of freedom display 10, which is illustrated as a split or dual display 10 in
By use of the six degree of freedom display, for the various types of medical procedures, improved results can be achieved by providing the surgeon with the necessary information required. In regard to surgical implants, the range of motion may be increased while reducing impingement of two-part articulating or fixed implants. This also enables maximum force transfer between the implant and the body. With therapy delivery procedures, by knowing the location of the catheter delivery tube and the specific port orientation, accurately aiming at the site is enabled to provide maximum delivery of the therapy at the correct site. This procedure also enhances and enables better results when using an ablation catheter by again knowing the rotational orientation of the ablation catheter and the ablation electrode relative to the area in the wall of the artery that requires ablation. Finally, by knowing the rotational orientation of a ablation or biopsy catheter, this type of catheter may be easily directed and aligned to tumors, stem cells, or other desired sites in an easy and efficient manner.
Turning to
Should the pre-operative planning proceed to block 236, which employs the image and sense-based pre-operative planning, this procedure will capture image data and sense parameters at block 242. In this regard, the captured image data may be the same image data that is captured at block 238. In addition to the captured image data, various parameters in the area of interest may also be sensed during the pre-operative planning state. In this regard, probes or sensors maybe placed in the area of interest to sense the parameters, such as temperature, pressure, strain, and force motions. For example, in a cervical disc implant, sensors may be positioned between adjacent vertebrae of interest to measure temperature in certain areas, which may indicate friction or impingement. Likewise, strain gauges may be positioned to measure forces to identify areas having unacceptably high forces between the vertebrae. Again, this data is then analyzed at block 240.
At block 240, the data from either the image based or the image sense based pre-operative planning is analyzed. Should the data only include image data from block 238, this image data may be used to identify areas of interest, the patient size, and be used to assist in preparing the surgical plan. By viewing this data, such as 4D data, which is essentially 3D data over time or static image data, certain abnormal or irregular movements in the area of interest may be identified. These areas may be identified by visual examination, by performing finite element analysis or other known motion analysis to create a 3D model of the captured image. The finite element analysis may include calculating the instantaneous center of rotation “x” or make this determination from the image data itself. The overall shape of the spine may also be analyzed via the image data to identify and determine various force vectors on the discs of interest by analyzing the entire spine, the curvature of the spine and the articulation area of the angle of the spine relative to the ground. This information may be used to find force vectors and loading on the various regions of the vertebrae of interest. Should the sensed parameters also be used, or alternatively only be used, these sensor readings, which can be measured statically or actively while the patient is moving are utilized to again identify points of interest or potential abnormal activities by sensing parameters, such as temperature, pressure, stress, and strain in the area of interest.
Once the data has been analyzed at block 240, the procedure proceeds to block 243, where the implant and the type of procedure is selected. The implant is selected, based on the various abnormalities identified in order to enable the surgeon to resolve the noted abnormalities. The implant is selected based on various parameters, such as material selection, performance characteristics, stiffness, style or implant type and sizing. Once the type of implant has been selected, sizing of the implant may also be pre-operatively performed, based on the data captured and analyzed at block 240. Sizing may be performed using known sizing templates, which provides the surgeon with a visual means of correlating the size of the implant to the area of interest. Alternatively, various sized templates automated in software may also be included and stored within the work station 36 and superimposed in the area of interest to provide a visual indication of the sized implant to select. In addition to selecting the type and size of the implant, the type of procedure to position the implant may be determined pre-operatively.
Once the size and type of implant is selected, as well as the type of procedure, the procedure proceeds to block 244. At block 244, the selected implant is implanted generally under surgical guidance in the area of interest. For example, a cervical disc implant may be implanted, as illustrated in
After implantation, there is a recovery period, exemplified by block 246. The recovery period will vary depending on the type of procedure, the type of implant, the patient's medical history and age, and other variables. During this period, the area of abnormality surrounding the implant may also heal and recover. For example, if a cervical disc was implanted, the muscular structure surrounding this area, which may have previously been overcompensating because of the abnormality may now have returned to a normal state. These surrounding structure changes, may affect the way the implant was positioned within the patient or the performance characteristics of the implant. In this regard, if the implant was positioned based upon abnormal surrounding structure, the implant may subsequently not provide the full range of motion as anticipated, thereby potentially resulting in further surgeries being required. Alternatively, the initially selected performance characteristics of the implant may have changed to due subsequent healing or other actions, thereby rendering the initial performance characteristics inappropriate for the current patient's condition. These performance characteristics can be any type of characteristics regarding the implant, including stiffness, actuation, loading, range of motion, etc. With the implant being an adjustable or tunable implant, corrections may be made to compensate for any subsequent anomalies observed by the surgeon. Again, the anomalies may result from healing of surrounding tissue, incorrect initial placement, changes in performance characteristics, or any other reasons. It should also be pointed out that if undesirable performance characteristics result after healing, the surrounding tissue and discs may also be damaged or deteriorate, thereby compounding recovery time and maybe requiring additional implants. This is the reason that providing the proper performance characteristics after healing is so critical.
After the patient has healed for some time, a post-operative exam is performed, exemplified at block 248. This post-operative exam may be conducted in different manners, depending upon the type of implant, the type of sensors and controls available with the implant, as well as the types of adjustments available with the implant. Some implants may have adjustment capabilities that require minimally invasive percutaneous type procedures, while other implants can be adjusted telemetrically or adaptively, as further discussed herein. The pre-operative exam may also be carried out using various types of equipment, again depending upon the capabilities of the implanted device, further discussed herein.
The pre-operative exam includes a motion analysis study, represented by block 250. This motion analysis study generally involves articulating the area of interest to determine range of motion, strength, etc. During this motion analysis study, the patient 14 is typically put through various motion testing. This testing may include various calisthenics, treadmill performance, weight lifting, gate analysis, etc. The motion analysis 250 can be performed and studied using an image-based procedure, set out at block 252, a sensor-based procedure, set out at block 254, or an image and sensor-based procedure, set out in block 256. It should also be pointed out that while block 250 is labeled motion analysis, the analysis can be performed via static image-based procedures or static sensor-based procedures, which are contemplated and included in the motion analysis study 250. In this regard, as opposed to putting the patient through various motion tests, the static image data or sensed data can be obtained and reviewed, via the image-based block 252 or the sensor-based block 254 to determine if the performance characteristics have changed. These static studies would simply look at the proper placement, impingement, etc. in the areas of interest to be used for subsequent postoperative tuning, further discussed herein.
The image-based procedure may be performed by either employing a localization or navigation tracking system or capturing image data, such as 3D or 4D image data, by an imaging device, such as a 4D CT imaging device. Should the motion analysis study be performed using localization or navigation technology, capturing image data and registration is performed as disclosed herein. U.S. Pat. No. 6,434,415, entitled “System for Use in Displaying Images of a Body Part,” issued Aug. 13, 2002, also discloses pre-operative planning using navigation technology, which is hereby incorporated by reference. In general, pre-acquired image data may be obtained, for example, in the cervical spinal region. Before this image data is obtained, fiducial markers and localization sensors may be attached to each vertebrae of interest. Once the image data has been captured with these sensors in place, the patient 14 may be positioned on a treadmill with the tracking system 44 placed in proximity to track the motion of each vertebrae. This motion can include a gate analysis study of the patient's motion as well. Before the motion analysis begins, the navigation space of the patient 14 is registered to the pre-acquired images. Once the patient 14 begins the motion or movement for the motion analysis 250, tracking of the moving vertebrae may be captured and illustrated on a display, such as the display 10, or any other display.
If localization and navigation technology is not employed, image data may simply be captured over time during the motion analysis 250, for example, by the use of a four-dimensional CT scan. With this image data captured, each individual vertebrae may be segmented out using known segmenting algorithms. These types of algorithms generally involve thresholding or templates, which will segment out each vertebra in the scan. Once each vertebrae is segmented out, finite element analysis may be performed using known finite element analysis. The finite element analysis may also be used to calculate the instantaneous center of rotation “x”. The information gathered during motion analysis 250 is used to determine the necessary adjustment of the implant at block 258. This information may include visualization of impinged areas around the implant, misalignment, etc.
Should the motion analysis be sensor-based, as illustrated at block 254, the sensor readings of various parameters are used to determine if there is any necessary adjustment, at block 258. The sensor based approach may either take readings from sensors located within the implant or from sensors attached to the patient during this analysis. The sensors may take temperature readings, which can indicate potential friction and higher forces, strain or stress readings, as well as load readings or any other parameter readings. Again, this information is used at block 258 to determine the necessary adjustment to the implant.
At block 256, both an image and sensor-based motion analysis may be conducted. This analysis essentially combines the image data at block 252 and the sensor data at block 254 to perform the post-operative analysis of the patient. Again, this information is used at block 258 to determine any necessary adjustments of the implant. When using both the image and sensor-based motion analysis, the sensed parameters may be synchronized in time with the image data to provide information on when the sensed parameters were captured relative to the time and the image.
At block 258, the data captured during motion analysis 250 is studied to determine whether any adjustments are necessary relative to the implant. For example, if a cervical disc was implanted and the patient healed and subsequent spinal alignment occurred, the range of motion may be compromised. In order to provide the proper range of motion, post-operative tuning of the implant may be necessary, based on the motion analysis study 250.
The post-operative tuning of the implant may also be necessary when the performance characteristics of the implant have changed. Performance characteristics may be selected, based on various criteria, such as when the patient is in a relatively static state, thus requiring certain performance characteristics, as compared to when the patient is in vigorous active state, where the performance characteristics must be changed. For example, the spinal implant may not need significant stiffness in a relatively static condition, while in very active condition, the spinal implant may require a stiffer cushioning. The performance characteristic may have been selected when the patient was disabled, so that once the patient heals, the performance characteristics may have to be adjusted accordingly. This adjustment may be conducted using a minimally invasive adjustment procedure at block 260 or a telemetric adjustment procedure at block 262.
In the minimally invasive adjustment at block 260, percutaneous adjustment of the implant may be performed by actuating various adjustment mechanisms within the implant, further discussed herein. For example, adjustment screws may be positioned at hinge points within the implant and engaged by a driver in a minimally invasive type procedure to provide the proper adjustment, thereby reacquiring the proper range of motion, via adjusting the articulating surfaces of the implant. Adjustment of the performance characteristic, such as stiffness may also be performed, as further discussed herein.
Should a telemetric adjustment procedure be performed at block 262, a non-surgical adjustment would be performed. In this regard, the implant may be driven telemetrically, using known telemetric type wireless systems, such as that disclosed in U.S. Pat. No. 6,474,341, entitled “Surgical Communication Power System,” issued Nov. 5, 2002, which is hereby incorporated by reference or any other known wireless telemetric systems. The telemetric system may be an RF based or electromagnetic based telemetric system, as is known in the art. The implant may be a passive or active battery powered device that includes motors, pumps or any other devices used to adjust the implant, further discussed herein.
Once the adjustments have been performed, the procedure proceeds to block 264 where the adjustment is confirmed. If the adjustment is proper, the procedure ends at block 266. If not, further adjustments are performed. This pre-operative and post-operative procedure provides better initial implantation accuracy and implant selection, as well as the opportunity for post-operative tuning or adjustment of the implant. The post-operative tuning enables adjustment of articulating surfaces, supports, or other parameters within the implant post-operatively without requiring revision surgery.
Referring to
The mounting platform 268 generally includes a rectangular-shaped beam 276 and a pair of outer attachment members 278. The rectangular beam 276 defines a plurality of peg holes 280, which are used to adjustably and removably retain the jig 270, along the member 276. The rectangular beam 276 also defines access and viewing holes or ports 282 enabling access from above and viewing of the relevant vertebrae. These access windows 282 can also be used to receive or pass surgical instruments during the medical procedure. Each attachment member 276 defines K-wire holes 284, which slidably receive the K-wires 274 in order to retain and secure the mounting platform 268 relative to the vertebrae 272.
An exemplary positioning jig 270 is illustrated in further detail in
The working platform 290 enables various instruments to be attached to the working platform, via the attachment mechanism 294, which may be a screw attachment, quick lock attachment, snap-fit attachment, or any other type of attachment mechanism. In one embodiment, a robot 298 may be attached to the working platform 290. This robot 298 may be remotely controlled and be used to drive milling, drilling, resection, or other instruments 300 through the passage 292. The robot 298 can either actuate the motor for the instrument 300 or can simply provide and act as an adjustable guide tube that may be controlled directly or remotely. Any type of known robotically controlled instrument may be utilized. Alternatively, the jig 270 may retain a manually adjustable guide tube that receives various instruments to be used during the procedure. The adjustable guide tube may also be lockable into a desired position in order to provide a rigid guide tube. Still further, the jig 270 may simply be used to pass and guide various instruments between the vertebral bodies 272. In this regard, the instruments as illustrated in
Generally, the mounting platform 268 will not include any localization sensors 58 or fiducial markers 60. The localization sensors 58 are generally positioned relative to the jig 270. The localization sensors 58 may be positioned on the guide tube and on the surgical instrument to determine orientation and depth of the surgical instrument 300, respectively. The localization sensor 58 may also be positioned on the robotically controlled device 298 to determine both orientation and depth of the instrument 300. The mounting platform 268 may also include localization sensors 58 if desired, which may be used to provide further localization of the vertebrae 272. It should further be pointed out that the dynamic reference frame 54 may be attached or integrated into the mounting platform 268 in order to provide increased accuracy during the implant procedure. In this regard, since any motion of the mounting platform 268 would be identified, via an integrated dynamic reference frame 54, this motion is positioned substantially adjacent to the area of interest and the area being operated upon, providing increased registration and tracking of the instruments during the procedure.
By providing the mounting platform 268 that spans multiple vertebrae, multiple segment implantation may be performed in a minimally invasive and surgical navigated manner between the multiple vertebrae 272. For example, as illustrated, three separate cervical discs may be positioned between the four vertebrae 272 without requiring removal or replacement of multiple jigs as would typically be necessary. By providing a mounting platform 268 that can accommodate various size jigs and can be positioned between various vertebrae 272, a more precise and accurate implantation may be achieved in a more minimally invasive and efficient manner.
A ball and socket type cervical disc implant 302 is illustrated in
The ball member 306 also includes a flange 326 defining screw holes 328 to receive bone screws 312. The ball member 306 also includes an articulating ball or spherical surface 330 that articulates with the socket 314. The flange 306 also includes adjustment or tuning portion 332 that defines a slot 334 for receiving another set screw 320 having head 322. Again, upon adjustment of the set screw 320, the angle 336 between the flange 326 and the ball 330 is adjusted in a minimally invasive manner, via percutaneous placement of a surgical driver that engages the head 321 of the adjustment screw 320.
By providing tuning or adjustment portions 316 and 332 relative to the ball 330 and socket 314, adjustment of the articulating ball 330 relative to the socket 314 may be made. Again, after a motion analysis 250 has been performed, a minimally invasive adjustment of the implant 302, such as the implant shown in
Referring now to
Each actuator/controller 338 and 342 may either be a passive type device or an active rechargeable battery powered device. If the actuator/controllers 338 and 342 are passive type devices, they may include resonant LC circuits, which will resonate when adjacent generating coils, generate an electromagnetic field, thereby enabling transmission of the sensed information from sensors 340 and 344. An example of such a system is set out in U.S. Pat. No. 6,474,341, entitled “Surgical Communication and Power System,” issued Nov. 5, 2002, which is hereby incorporated by reference. Other types of known wireless telemetric systems may also be utilized. Actuator/controllers 338 and 342 may also be battery powered using rechargeable batteries that are either embedded within the implant or positioned remote from the implant and implanted within the patient, similar to known pacemaker technology. These rechargeable batteries may be recharged telemetrically similar to existing pacemaker batteries, as is known in the art.
If the system is a passive system, the data may be acquired from the corresponding sensor during the motion analysis study 250 in the post-operative exam 248 during the various motion tests performed on the patient 14. This information is gathered at the time of the study and is used to analyze whether or not further adjustments are necessary to the implant 302. Alternatively, if the system is an active system and battery powered, data may be sampled over time, stored in memory and transferred during the motion analysis study 250 or during other transfer periods, as further discussed herein. With this type of telemetric system, the implant 302 may be adjusted remotely by driving either actuator/controller 338 or 342 to remotely adjust the adjustable set screw 320, via known actuation type mechanisms. Again, while a hinge/set screw adjustment mechanism is shown, any other appropriate adjustment mechanism may be employed, such as worm gears, pinions, etc. Thus, telemetric adjustment 262 may be performed by simply positioning a corresponding transmit and receiving instrument adjacent to the implant site to both receive sensor information and remotely drive the actuators/controllers 338 and 342 to provide remote telemetric adjustment of the implant in a non-surgical manner. By adjusting either the angle 324 or the angle 336, the range of motion, contact, articulating surface adjustments, or other type of adjustments to relieve impingement and increase the range of motion may be performed in a post tuning technique. Briefly,
Referring to
In order to provide for either minimally invasive or telemetric adjustment of the implant 346, the bladder mechanism 352 is separated into a plurality of individual bladders 354. As illustrated, the implant 346 includes three adjacent bladders 354. Located within each bladder 354 is a sensor 356 that is used to sense the pressure within each bladder 354. These sensor readings are passed to a bladder control system 358. The bladder control system 358 may again be a passive device or an active battery powered device. If passive, the sensor information will be received during the motion analysis study 250 and adjustment may be performed telemetrically during this study using known telemetric driving devices. If the bladder control system 358 is an active powered system, the system may either operate similar to the passive system or may be an adaptive system that provides real time adjustment for the implant 346. In this regard, each sensor 356 may sense pressure differences in each bladder 354 while the bladder control system 358 attempts to equalize the pressures in the bladders 354 in a real time manner. The bladder control system 358 includes a processor controller 358 and either a battery or known passive driving device. The bladder control system 358 also includes a pump used to transfer fluid retained within the bladders 354 by controlling remote valves 360 and a memory if necessary for storing sampled data.
The implant 346 may also include a reservoir 361 that retains a drug that may be delivered through the external valve 360 and controlled by the bladder control system 358. In this way, controlled drug delivery to the surrounding bone may also be achieved with the implant 346. The drug can include a bone morphagenic protein (BMP) that is able to increase bone density and fusion of broken bones, by delivering the BMP over time to the surrounding infected bones. This drug delivery capability of the implant 346 may be actively delivered if the system is battery-powered, or telemetrically delivered, via an active or passive device during patient exams. Delivery systems may be any appropriate drug delivery system. For example, the drug delivery system may be substantially programmable, such that the drug is delivered according to a preprogrammed schedule from a selected reservoir. Alternatively, the drug delivery system may be substantially wireless, such that the drug is delivered due to a wireless command. Although it will be understood that any appropriate drug delivery system may be used in conjunction with an implant.
In operation, the implant 346 may be used to sense pressure in each individual bladder 354, via the sensors 356 during the post-operative motion analysis 250. With this information, a surgeon can direct the bladder control system 358 to compensate for any abnormalities in pressure in the bladders 354 in order to try to achieve uniform pressure throughout the implant 346. The bladders 354 generally include a saline solution that can be transferred between bladders 354, via the bladder control system 358 and control valves 360. In addition, there is an external valve 360 that may be used to release saline fluid harmlessly into the body to relieve pressure. Alternatively, the external valve 360 may be used to receive additional fluid percutaneously in a minimally invasive way. Thus, the implant 346 may be post-operatively adjusted or tuned, depending upon the healing of the patient, post-operative trauma, or to provide further refinement and increased performance of the implant 346.
Alternate embodiments of the implant 346 is illustrated in 16a-16c. Here again, like reference numerals are used to identify like structures. The spinal implant 346 is substantially similar to the spinal implant illustrated in
Implant 346, illustrated in
Another embodiment of the spinal implant 346 is shown in
The force control system 362 may be used to adaptively or actively adjust the implant 346 if the force control system is an active battery powered system. Alternatively, the force control system 362 may adjust the force within the implant 346 during the telemetric adjustment 262 if the system is simply passive. The bladder control system 358 and the force control system 362 may be formed using conventional micro electronics and mechanical devices or may be formed from micro electromechanical system (MEMS) technology, known in the art.
A multiple segment implantation is illustrated in
Controller 374 is used to sense various parameters again, such as temperature, pressure, etc. where actuators 372 are used to tune or adjust each implant 368 accordingly. The controller 374 may be implanted adjacent to the spinal region, similar to a controller and battery for a pacemaker. The multiple segment implantation with each implant 368 communicating with the other surrounding implants 368 enable real time adaptive control of this spinal region, such as the cervical spinal region of the patient 14. In other words, the controller 374 may sense, via the sensors 370 whether any one of the implants 368 is under too much pressure or one may be too laxed and adjust accordingly, depending upon the patient's movements. In this regard, when the patients at rest, extra support between the vertebrae 272 may not be necessary. However, when the patient 14 is doing physical activities or exercise, additional support may be necessary between each vertebrae 272 and each implant 368 may be expanded during this period in an adaptive manner. Alternatively, the controller may again simply be a passive controller or an active controller and used to send and receive information, as well as adjust the implants 368 during the postoperative exam 248, via the telemetric adjustment 262.
Turning to
Referring now to
The procedure 230, as well as the associated implants, systems and instruments, enables both pre-operative and post-operative review and analysis. Additionally, post-operative tuning of the implant may also be achieved without requiring revision surgery or highly invasive types of procedures. In this regard, either minimally invasive or telemetric adjustments of the implants may be achieved.
As discussed briefly above, with reference to
The following description may be a separate procedure or may be understood to be any part of the procedure 230 and particularly included within block 243 and 244, regarding selecting an implant and implanting an implant under surgical guidance 243, 244. It will be further understood that although the following discussion may relate generally to a disc or nucleus replacement or implant, that any appropriate implant or procedure may be used. For example, the procedure and systems may be used to plan and select a procedure for any appropriate abnormality such as a humeral head or stem abnormality, a knee abnormality, a shoulder abnormality or any other abnormality. Therefore, the planning and implantation of the disc or nucleus is merely exemplary and not intended to be limiting.
With reference to
Broadly, the system 400 can assist a surgeon or user in making judgments regarding a selected implant, such as size, geometry, volume and the like and performing a procedure to achieve a result once the selected implant is positioned. For example, the system and method may assist a surgeon in removing a selected amount of tissue before placing an implant relative to the anatomy. Determining a substantially precise amount of tissue to be removed may assist in performing a procedure within fairly strict boundaries such that it may be helpful to achieve a selected outcome that may be most preferable for a patient.
In addition, the method may assist in selecting an implant that most precisely meets a predetermined size, shape, and other requirements to assist a patient. For example, for a motion preserving device, such as a nucleus, prosthetic disc, femoral implants, knee implants, or the like, substantially precise placement and preoperative planning may be used to increase the effectiveness of the implant. Therefore, various image gathering techniques and devices can be used to assist a user, such as surgeon, in selecting an implant for a procedure and ensuring that a patient is substantially prepared for the procedure. This preparation and planning may ensure that the most appropriate implant is selected and precisely placed for completing the procedure. Therefore, using various navigation systems and techniques and image acquisition systems may assist in substantially precise planning to assist in a procedure. The parameters that may be considered include the type of implant, implant shape or geometry, implant size, placement and kinematic analysis of proposed implants.
The method 400 starts at block 402 by acquiring a patient image. The patient image may be acquired in any appropriate manner, either a time before the operative procedure or during the operative procedure, as in an operating room prior to performing a surgical procedure on any portion of the patient. For example, as discussed exemplary herein, the images may be acquired of the patient prior to removing a selected portion of the spinal column, such as a nucleus or a disc. Therefore, the acquired images of the patient in block 402 are generally of the patient in a preoperative or natural state. The images may be acquired with the patient in any appropriate manner. For example, the images may be acquired using a MRI, a CT scan, x-rays, fluoroscopic C-arm, ultrasound or any other appropriate method including imaging methods discussed above. Therefore, it will be understood that the images may be collected in any appropriate manner.
The images may be collected to be displayed on the display 10, or any appropriate display, prior to and during an operative procedure. The display 10 may be connected to the work station 36 for use during an operative procedure. In addition, the display 10 may be connected to a different work station for different portions of the procedure. For example, the work station 36 may be provided for an operative procedure to ensure that the planned procedure occurs and for navigation. Nevertheless, a different work station may be provided for the planning of the procedure, as described herein and the procedure and images stored for later use. It will be understood that various images may be acquired of the patient to allow for modeling and planning of a selected procedure as discussed herein.
With additional reference to
The disk 16 may include an annulus which surrounds the nucleus 418. This difference between the annulus and the nucleus may be a difference in the viscosity of the materials or rigidity of the materials. Generally, the annulus surrounding the nucleus 418 may be substantially more rigid or less fluid than the nucleus 418. Therefore, it will be understood that an implant to replace either the annulus of the disk 416 or the nucleus 418 of the disk 416 may include similar properties or may be cured, such as with materials, time, radiation and the like, to achieve selected properties.
During the preoperative stages, the various images may be achieved by obtaining a plurality of images of a patient, such as through various known methods and any appropriate method. In addition, the views may include models, such as a multi-dimensional model or 3-D model, of the selected portion of the anatomy. Therefore, various images, such as plurality of CT, MRI or X-ray images may be used to create the various views 410-414 and may be also used to create two, three, or other dimensional models of the area of interest or an atlas model may be used as well. The various models or images formed of the models may also be used for aligning or selecting an implant during an implant procedure. For example, the models may be moved and the implant aligned along the plurality of planes, such as the coronal or sagittal plane and any other appropriate view, such as an axial view. Alternatively, no model may be made and simply the two, three, or four dimensional images or image data acquired may be used for planning and carrying out the procedure.
These various views and models may allow a user, such as physician, to determine various dimensions of selected areas such as the disc 416. Therefore, the physician may be able to measure a distance H that may include a height of the disc 416. Various other measurements such as width W of the disc 416 and depth D may also be measured. These measurements may be found due to various modeling that allows for a coordinate system including at least three axes, X, Y and Z. This may allow a physician to determine a selected volume of the disc 416. A volume of the nucleus 418 may also be determined using these or other various measurements. In addition, the model may be used to precisely determine a plurality of measurements, greater than the height, width, and depth of the disc 416 to precisely determine a volume of the nucleus 418. Alternatively, as discussed herein, a template program may be used to position an image relative to the models or image data of the patient to determine various dimensions. Therefore, the preoperative images may be used to determine a selected size or shape of a portion of the anatomy.
In addition to determining a selected size, geometry, volume, and dimension or other size characteristics, a user may also determine various other characteristics of the anatomical portion or an implant to replace the anatomical portion. For example, the user may determine that a selected viscosity of rigidity of the implant may be positioned in the area determined in the planning screen 404. For example, an user may determine that a selected viscosity is required to provide an implant to replace the nucleus 418. As discussed herein, during the planning stage the user may also determine an amount, type, duration and other specifics to cure a selected material to achieve various characteristics of material to achieve a planned procedure. These determinations may be provided with kinematic analysis performed by the workstation 38.
It will be understood that although the display 10 exemplary includes a view of the spinal area that any appropriate portion of the anatomy may be imaged. For example, a proximal portion of a femur may be imaged to determine a volume of a femoral head and intramedullary canal for various procedures, such as a femoral head implant. Therefore, it will be understood that acquiring a patient image in block 402 may be used to acquire any appropriate image of the patient and an image of the spine is merely exemplary.
With reference to
In addition, various reference frames may be attached to selected portions of the anatomy, such as the dynamic reference frame 54. In addition, separate dynamic reference frames may be affixed to the vertebrae 406, 408 to allow for a dynamic determination of the real time position of vertebrae 406 relative to the vertebrae 408 and vice versa. Also, various fiducial markers or anatomical landmarks may be used to reference the anatomical portions for registration, as discussed above, such as the vertebrae 406, 408, in the system.
Alternatively, the images or models positioned in the coordinate system may be used to relatively determine sizes. Therefore, the measurements may be substantially precise in determining the various dimensions and volumes of the selected portions of the anatomy. The dimensions determined in block 424 can be known to be substantially correct due to the actual image data acquired of the patient to form the digital model of the anatomy in question.
The image produced on the planning screen 404 may be used to model the anatomical portion with a selected implant or with a selected anatomical motion. The model of the anatomical motion may assist a user in selecting an appropriate implant to achieve a desired or selected anatomical motion. Therefore, it will be understood that the images and planning screen may be used to plan a plurality of characteristics for an implant or procedure as discussed herein. The system and method 400 may be used to determine a selected size, geometry, type of implant, position, physical characteristic including viscosity and malleability and other appropriate characteristics. It will be understood, therefore, that those characteristics discussed herein are merely exemplary of the characteristics that may be planned and selected using the system 400.
With reference to
The dynamic reference frames may be any appropriate type such as optical, acoustic, electromagnetic, and the like. It will be understood that any appropriate dynamic reference frame may be used. It will also be understood that a dynamic reference frame may not necessarily be used if the portions of the anatomy are substantially fixed relative to one another. The images on the display 10 may be referenced with an instrument, such as the probe 62, and the relative spatial positions of the various portions of the anatomy are then known as long as the portions of the anatomy do not substantially move relative to one another. Therefore, dynamic reference frames may not be necessary, but may be used to assist in tracking the real time position of the patient during the surgical procedure, further discussed herein.
With reference to
Determining a procedure in block 426 may also include determining exactly what will occur during an operative procedure. In addition, it may also include determining the amount of tissue to remove, determining an amount of resection, determining a substantially ideal distraction height, and the like. For example, if it is determined that the nucleus 418 must be removed or replaced, determining the procedure in block 426 may also include determining the volume of the nucleus 418 to be removed and from where. Therefore, if the volume of the nucleus to remove is about 10 cc, this may be determined by determining the procedure in block 426. The exact amount may be determined because of the dimensions taken in block 424 using the model formed in block 422. An exact amount of removal may also assist in achieving a selected result. The procedure may include a selected volume of material removal and the selection and positioning of an implant may substantially rely on material removal. Therefore, the tracking and planning system and method allows for a substantially pre-operatively chosen resection plan and implant.
Once the procedure is determined in block 426, an implant may be selected in block 428. Selecting the implant in block 428 may include selecting an appropriate type of implant, selecting an appropriate size of an implant, including a volume, size, geometry and other appropriate considerations and confirming that the implant may achieve selected results from the patient. These results may also include kinematic studies based on using a selected modeled implant. It will be understood that a kit 462 (
If the kit 462 includes a plurality of known implants, including a known size, shape, geometry and other known characteristics, the implant may be modeled in the images from the patient in block 430. Therefore, the implant selected in block 428 can be modeled with the model made in block 422 and block 430. Because the dimension and size of the implant selected in block 428 is known, it can be positioned in the model of the patient formed in block 422 to ensure that the selected implant will achieve a selected result. It is generally known in the art to provide selected algorithms in computer programs to provide for dynamic, kinematic, or static modeling of a selected portion of the anatomy to ensure that a result is achieved.
Also, an implant may be modeled in block 430 that has been digitally augmented or digitally created to achieve a selected result. Therefore, a template or general sizing program may be provided. The work station 36 may be able to operate the template program which includes a plurality of template shapes, sizes, geometries and volumes to form the implant selected in block 428 which can be modeled in the anatomy in block 430.
For example, with reference to
The template 444 may also be any other appropriate program. For example, the template 444 can be a portion of the program that allows for computer aided designing of an implant. In addition, relatively more simple drawing programs can be used to draw an implant to form the template shape 444 that may be used to later define an implant for the spine. That is the template program 444 or template design may be any portion of a program that allows a user, such as a physician, to model a selected portion of the anatomy, such as the selected position or removal area of the disc 416 for selecting and/or designing an implant to be used in the procedure. In addition, various implants may be imaged and positioned in the system to be used as the template program 444. Regardless, it will be understood that any appropriate method or program may be used to define the template 444 for defining and selecting an area of the anatomy for an implant or designing an implant.
Therefore, the generic template 444 may be sized on the display screen 440 to meet a selected result to allow for choosing a non-pre-saved implant. In addition, the template shape program 444 may be used to form a substantially custom implant for implantation into the portions of the anatomy. It will be understood that the template shape 444 as a part of a template program can be used to determine a size and model it in block 430 to determine whether the template shape dimensions and sizes 444 may be used to achieve selected results within the patient. Also, any appropriate shape may be used including oval, spherical and others. Moreover, the shape need not be uniform, but may include a unique geometry. The shape may also be used to determine the volume of tissue to be removed, as well as from where the tissue should be removed.
In addition to the template shape program 444, a non-saved implant shape may be substantially real-time modeled into the work station 36. Briefly, an implant may be referenced or shaped defined with an instrument. For example, the probe 62 may be used to touch a plurality of points on the non-saved implant to determine a plurality of points in shape relative to the implant. The plurality of points can then be integrated using the work station 36 to substantially model the non-saved implant shape within the work station 36 such that the real time model implant can be modeled in the block 430 to determine whether it will meet the determined procedure in block 426.
In addition, an implant may be modeled using a plurality of methods, such as an MRI, a fluoroscopic imaging device, and the like. In an intraoperative procedure to form a model of the implant that may then be positioned relative to the images on the screen 10. Therefore, rather than having the work station 36 model the implant from a plurality of points determined with the probe 62, the work station 36 may model the implant using image data captured by selected imaging devices. Even other imaging devices, such as a scanner, including a three-dimensional scanner, and the like may be used to scan the image of an implant.
Therefore, it will be understood that all types of implants may be used in the method 400. Implants using predetermined dimensions may be modeled in block 430 as may be a general template program shape 444 and a substantially real time shape determined implant. The method 400 may be substantially used with any appropriate implant or procedure. Similarly, it will be understood that known implants, sizes and dimensions, template shapes and real time determined implants may be used for a plurality of procedures in addition to a spinal procedure. For example, knee portions, femoral portions, humeral portions and the like may also be modeled in block 430 with a selected portion of the anatomy.
Once the implant has been modeled in block 430, it can be questioned in block 450 whether the model implant modeled in 430 achieves the selected results or characteristics. If the answer is No in block 452, the selection of the implant can be reselected in block 428 and then remodeled in block 430. Therefore, it will be understood that the selection of the implant may be iterated until the selected implant achieves the selected results or characteristics and the answer is Yes in block 454. The decision can be determined either by the surgeon doing the procedure, or the processor, either in the workstation 36 or other processor, can assist in its determination based upon running known anatomical kinematic modeling.
The processor in the workstation 36 can be used to determine an implant that may best relieve the modeled abnormality. For example a plurality of similar procedures may be saved such that the processor may determine a possibility that a previously used implant may achieve a similar result in the instant situation. For example, the system may suggest a particular implant based upon the size of the patient and a previously performed procedure with a patient of similar size. Moreover, the processor may use the modeled patient and the known implant dimensions, types, etc. to replace a selected volume or tissue or achieve a natural or selected kinematic motion.
A plurality of implants may be provided to be modeled in block 430. The plurality of implants may assist in assuring that a substantially selected outcome is achieved. The selection may be substantially reduced due to determining the procedure in block 426 and selecting an implant to substantially achieve the procedure in 428. In addition, it will be understood that each of these steps to block 456 may be performed substantially preoperatively. The images of the patient may be obtained in block 402 and the model made of the patient in block 422 may be performed substantially before the patient ever reaches an operating room. Therefore, known and unknown implants may be modeled in the patient model in block 430 to determine whether a selected result can be achieved in block 450. That is, known implants can be modeled in the model in block 430 or the template program 444 can be modeled in the patient in block 430 to ensure that the implant selected during the procedure may achieve a selected result. Nevertheless, it will be understood that the modeling may occur substantially intraoperatively to assist in assuring that the implant selected for implantation may achieve the result without later confirmation or that later confirmation may substantially ensure achievement of the selected result.
Nevertheless, once the implant has been selected in block 428 and it has been determined that the implant will achieve selected results in block 450 and the Yes determination block 454 is achieved, the procedure of implanting the implant may proceed.
In selecting and determining an appropriate implant, it will be understood that various models, both static and dynamic, may be created. Any of these models may be optionally stored in block 456. That is, the models may be electronically stored in the work station 36 or may be stored in a substantially permanent form, such as printout. Nevertheless, the model that may be stored in block 456 may be used in assisting a physician during an operative procedure. As discussed herein, the stored models may assist a user, such as physician, in ensuring that an appropriate positioning of the implant has been obtained and that an operative procedure has been successful in implanting the implant. Moreover, by storing and identifying the proper implant for a particular shape and size patient, the method or system 400 may also suggest an appropriate size implant based upon the pre-acquired image data and upon storing and identifying the implants to the particular size patients. In this way, the selection process may be quicker by saving or providing implants that are initially suggested that are very close to the proper size and shape.
Regardless, it will be understood that the steps 402-456 of the method 400 may occur substantially preoperatively. That is, the images may be acquired of the patient in block 402 and the various models and testing performed to select an appropriate implant and procedure for the patient. This may be done prior to the patient being brought to an operative theater and may reduce trauma to the patient and time in the operating theater. It may also reduce the time of the operative procedure to decrease time of healing and increase post-operative return to a normal life of the patient. In addition, it will be understood that each of the steps may occur during an operative procedure. Even during the operative procedure, the planning and selecting of a particular procedure and implant may reduce the time of the operative procedure, for example, in place testing and trialing may be reduced due to the preoperative modeling of the implant.
Whether or not the planning and modeling occurs pre or intra-operatively, the procedure may proceed to implanting the implant in the patient. Similar to block 244 in
As described herein, each of the instrument for removing or resecting selected anatomical portions, the instrument for positioning or implanting the implant, and the implant itself may be substantially navigated or tracked using appropriate mechanisms. For example, tracking sensors may be affixed to any of the appropriate portions (
With reference to
Alternatively or in addition, a volume filling material such as a braided implant 478 or flowable material may be provided in a bladder implant 479a, illustrated in
The flowable material may be free flowed into the area of the nucleus or may be flowing into a package which is implanted in the area of the nucleus 418 or the disk 416. The material that is flowed into the implant may also be substantially cured to achieve selected characteristics, such as a selected rigidity or viscosity. As discussed herein, various instruments may be tracked relative to portions of the anatomy and portions of the implant. For example, the implant package may include tracking sensors such that various portions of the package may be tracked as it is filled with a selected flowable material. A curing source, such as a UV source, can then be tracked relative to the flowable material to determine a selected curing of the material. The curable material may include a characteristic that changes depending upon the amount of curing that occurs. Therefore, the tracking of the UV source or any other appropriate curing source can be used to achieve selected characteristics that are substantially heterogeneous, yet precisely positioned, within the implant.
As discussed above, the volume of a selected area, such as the volume of a nucleus 418 may be determined using the various modeling techniques. Therefore, a selected volume of the volume filling implant 478 may be provided to substantially precisely fill the planned removed volume of the nucleus 418.
Regardless, it will be understood that the kit 462 may provide or include a plurality of various implants. The various implants may either be part of a pre-formed kit or may be pre-selected and determined depending upon the implant selected in block 428. Therefore, the kit 462 may be substantially customized for a particular procedure because of the implant selected in block 428. The kit 462 may also include a plurality of implants from which a selection may be made after the planning and substantially intra-operatively. Nevertheless, obtaining the selected implant in block 460 may include selecting an implant from the kit 462. Alternatively, it may include designing and obtaining a substantially custom implant for a selected patient. Because the implant selected in block 428 can be modeled and altered for a selected patient and verified in block 450, the implant obtained in block 460 may be substantially customized for a particular patient.
Once the implant is obtained in block 460, a tracking sensor may be attached in block 480 to the selected implant obtained in block 460. The tracking sensor 58 may be any appropriate tracking sensor such as those discussed above, including electromagnetic, optical, and acoustic. Connecting the tracking sensor in block 480 may optionally allow for substantially dynamically determining the location of the obtained implant relative to the selected portion of the anatomy. As discussed herein, the implant may be substantially guided with selected navigation systems, such as those described above, to allow for substantially precise placement of the implant. As discussed above, the implant may be modeled in the anatomy and a selected position confirmed in block 450 for efficiency. Therefore, navigating the implant to a selected position using navigation systems may assist in assuring that the implant achieves its selected or preselected location or the target can be superimposed on the image data. Nevertheless, it will be understood that connecting a tracking sensor to the implant is not required or may occur at any appropriate time before implanting the implant into the selected anatomical position. If a tracking sensor is used, it may be registered within the patient space. This allows the position of the implant to be determined in a real time manner.
Once the implant has been obtained, the selected area of damaged tissue may be removed in block 482. The damaged tissue being removed may generally include the tissue that is selected during selecting the procedure in block 426. Removing the damaged tissue in block 482 may include removing a selected portion of the nucleus 418, removing a selected portion of the disc 416 or other appropriate portion. It will be understood, however, that removing the damaged anatomical portion in block 482 may also include removing any selected portion of the anatomy depending upon the selected procedure such as a femoral head, a humeral head, or other appropriate portions. Therefore, removing a selected portion of the nucleus 418, as discussed herein, is merely exemplary and not intended to limit the scope of the following claims.
In removing the damaged anatomical portion in block 482, an instrument may be navigated in block 484. Navigating the instrument in block 484 may be performed using any appropriate navigation system or technique. As discussed above, the tracking sensors 58 may be connected to the instrument 52 to perform a selected procedure. It will be understood that the instrument 52 may be any appropriate instrument, such as a scalpel, a reamer, a suction device, and the like. In addition, the tracking sensors 58 may be any appropriate sensors such as optical sensors, electromagnetic sensors, acoustic sensors and the like. It will also be understood that the sensors 58 can be registered and tracked within the patient space to assist in removing a selected portion of the anatomy in block 482. This area in which tissue is to be removed may also have a template super-imposed onto the image data of the tissue that should be removed, as discussed herein. By also super-imposing the surgical instrument on the image data, a real time precise image of the amount of tissue removed can be tracked by the system. Once the procedure is planned, it will be understood that any appropriate mechanism may be used to perform the procedure. As discussed herein, the tool or the navigation of the procedure may be displayed on the monitor 10.
Alternatively, a substantially automated or robotic system may be used to perform the predetermined or pre-selected surgical plan, substantially autonomously or with supervision. Therefore, it will be understood that the selected or determined plan may be performed according to any appropriate method, such as with a user or with a robotic system. In addition, the robotic system may be a partial robotic system that includes a portion that is exterior to the patient or that is substantially contained within the patient, such as that illustrated in
With reference to
Navigating the instrument and illustrating it graphically 486 on the screen 488 may ensure that the selected procedure in block 426 is substantially achieved. During the selection of the procedure in block 426 it may have been selected to remove a selected volume of the nucleus 418 and navigating the instrument may ensure that the planned procedure is achieved. As discussed above the various instruments may be registered and then tracked within the selected space, such as the patient space to ensure that the location of the instrument is known and can be displayed properly as the graphical display 486.
Navigating the instrument in block 484 may assist in ensuring that the determined procedure, determined in block 426, is substantially achieved. This may be useful when providing an implant for a spinal procedure, such as replacing the nucleus 418. Briefly the nucleus 418 may include a selected volume that is desirable to be substantially replaced. Therefore determining the procedure in block in 426 may include determining a selected volume of the nucleus 418 to be removed. Using the tracking system, the instrument 486 may be displayed on the screen 487 to be used to ensure that the determined procedure is performed. This may allow the selected implant selected in block 428 to substantially achieve the selective results determined in block 450.
After navigating the instrument in block 484 to remove the damaged anatomical portion in block 482, the implants obtained in block 460 may be positioned in block 492. Positioning the implant may also performed with use of the tracking system. As discussed above a tracking sensor may be connected in block 480 to the implant prior to attempting to position the implant in block 492. Also the implant may be substantially positioned by visualization of a user, such as a physician. Regardless after the damaged tissue is removed in block 482 the implant can be positioned in block 492.
With reference to
A selected implant, such as the substantially deformable braid implant 478 may be passed through the instrument graphically illustrated as 508 and positioned in the area where the nucleus 418 was removed. Therefore a pre-selected volume of the deformable tissue material 478 may pass through the instrument that may be navigated to a selected position using the display 500. Due to the determination of the procedure, the proper volume of the tissue implant can be positioned in the selected portion of the anatomy to ensure that selected results are achieved.
Alternatively, a deformable or shape memory implant, such as those described in U.S. Pat. No. 6,620,196 may be deformed and passed through an instrument that is graphically illustrated as 508. The shape memory implant may be placed under a force to deform it to allow it to be passed through a selected portion of the anatomy into the area to which the nucleus 418 was removed. Once the forces have been removed, such as when the implant passes out of the instrument 508, the implant 474 may achieve a substantially shape memory shape to fill the area of the removed nucleus 418.
As briefly discussed above (
In addition, the flowable material that may be flowed into the bladder or into the anatomy itself may include any appropriate material. For example, substantially natural materials such as bone particles or the like may be injected, alternatively, substantially synthetic materials may be implanted. For example, a curable material, such as polymer that is cured with a radiation, such as UV radiation, or a polymer that is cured with an activation component, such as a generally known bone cements, may be used.
If a curable material is used that is cured with a selected curing procedure, such as radiation with UV radiation, tracking of a probe which applies UV radiation to the curable material may be performed. This may allow substantially precise curing of a selected area of the implant to a selected amount. For example, it may be selected to cure a substantially posterior portion of the implant to a selected amount to provide a selected characteristic of the material while curing an anterior portion of the implant to a different amount to provide a substantially different characteristic of the material. For example, a longer curing time may make the curable material substantially more viscous or rigid and that a shorter cured time portion of the material is substantially soft relative to the longer cured time material. Therefore, the curing probe, such as the UV probe, can be substantially precisely navigated relative to the curable material to allow for precise curing times of various portions of the material to provide various types of characteristics of different regions of the material.
It will be understood, however, that various types of radiation may be used, such as gamma or electron beam, to cure portions of the material. Nevertheless, being able to substantially precisely locate and track the position of the curing probe may allow for a substantially heterogeneous implant, which is one that includes different characteristics for different portions of the implant. Also, other fillers, such as inorganic or organic fillers, including calcium carbonate, titanium dioxide and the like may be provided in a substantially precise places to alter the viscosity of a material in that location. Again, the positioning of the probe which introduces the materials into the implant may be tracked with tracking sensors. In addition, or alternatively, various reinforcing materials, such as metallic and non-metallic meshes, may be used to reinforce portions of the implant to provide a selected characteristic at a selected portion of the implant.
In addition, such as with the use of an inflatable bladder, the bladder may include portions that may be adhered or interconnected with the curable material such that the bladder may move at a selected rate with the curable material or a portion of the material, including a selected characteristic, is held relative to a selected bladder portion. Therefore, it will be understood, as discussed above, that the bladder may be substantially navigated to ensure that the portion of the material that is engaging a selected portion of the bladder is in a selected area, dimension, and the like.
It will be understood that various other portions may be navigated as well, such as coatings for the implant, modular portions of the implant and the like. It will be further understood that the tracking assembly may be used to substantially position an implant to a substantially minimally or small invasive procedure without substantial visualization or visually guiding of the implantation. Therefore, the system 400 can be used to plan a procedure and selection of an implant according to various selected characteristics. For example, the system 400 may model the anatomy through a substantially dynamic modeling and chose an implant to achieve the desired dynamic model. Thereafter, the system 400 may be used to substantially guide the implantation and procedure, substantially non-visually, to achieve the selected results. Therefore, visual implantation of the implant may not be necessary due to various features, such as the tracking sensors and the like.
Regardless of the implant selected, the implant may be selected due to the determined procedure to ensure that the volume removed in block 482 may be substantially filled or a selected anatomical position be obtained after positioning the implant in block 492. It may be possible that the determination of the procedure in block 426 and the selection of the implants in block 428 that the implant may be pre-selected without trialing to ensure a proper or selected fit. Therefore, positioning an implant may be done in substantially a single step without necessity of trialing.
After positioning the implant in block 492, the position of the implant may be confirmed in block 512. The confirmation of the position of the implant can be confirmed in block 512 intra-operatively or post-operatively. If the position of the implant is desired to be confirmed intra-operatively it may be confirmed with an instrument such as the fluoroscopic imaging system 16. The imaging system 16 may be used to obtain an image of the selected area of the anatomy and display the image of the selected area of anatomy on the screen 10. The implant may be substantially viewable using the x-ray instrument or may include markers, such as tantalum markers, dyes, or other appropriate radio-opaque materials, to ensure that the instrument or implant may be viewed postoperatively. Regardless, the confirmation may be used to ensure that the implant has been positioned in the predetermined position.
In addition, as mentioned above, various other wireless sensors may be positioned in the implant. For example, electromagnetic tracking sensors may be positioned in the implant, such that after the implant is positioned a determination of a location, orientation and the like may be determined for the implant using the tracking system 44. Therefore, the position of the implant may be confirmed using selected procedures, such as obtaining an image of the implant, which may include substantially radio-opaque portions or determining a location of the implant using various wireless sensors. As discussed above, the implant, which may include the bladder 479a or other appropriate portion, may include the tracking sensors 58, such as electromagnetic sensors, that may be tracked by a tracking array. Therefore, the tracking array, either intra or post operatively, may be used to track a position or other characteristic of the implant relative to the anatomy to ensure that the position of the implant is the preselected position of the implant. In addition, the tracking sensors may be used to ensure that a selected volume, such as filled volume of the bladder, has been achieved. Therefore, various portions, such as radio opaque material, including dyes, tantalum or other marker, and the like may be viewed using an X-ray source and/or tracking sensors may be used to track a position of the implant such that the position or characteristic of the implant can be substantially verified or confirmed after the implant has been positioned relative to the anatomy to ensure that the implant has been positioned in a preselected portion of the anatomy in a preselected manner.
In addition or alternatively, the probe 68 may also be used to indicate or touch a portion of plurality of points of the implant, such that the work station 38 or the system may be used to determine the precise location of the implant. The precise location of the implant may then be modeled relative to the anatomical portion and displayed on the screen 10. Regardless, it will be understood that the implant may be modeled or viewed as an image on the screen 10 relative to the anatomy to insure that the implant is positioned in a selected position. In addition, a predetermined or preselected position may be superimposed or underimposed relative to the image of the patient to insure that a substantially matching of the implant implanted position is relative to the selected position.
In addition, further modeling may occur in the confirming of the position in block 512 to ensure that the dynamic movement of the implant as positioned will achieve selected results. In addition, a virtual or digital subtraction method may also be used to determine or confirm a selected location of the implant. Such a system is generally described in U.S. patent application Ser. No. 10/116,631, entitled Method And Apparatus For Virtual Digital Subtraction Angiography, filed Apr. 4, 2002 the disclosure of which is incorporated herein by reference. Briefly, the work station 38 may be used to intraoperatively subtract or compare a preoperative or planned position with the post implantation position. For example, an image of the patient may be taken preoperatively for the planning procedure and an image of the patient may be taken after the implant has been positioned, both may also be substantially intraoperatively. The two images may then be compared and both may be enhanced substantially virtually to substantially insure a selected position of the implant or a selected position of the anatomy after positioning of the implant. The images may be taken in any appropriate manner, such as with a fluoroscope or MRI, or the like. Therefore, the images may be substantially virtually compared along a plurality of planes, such as two-dimensional planes, or comparing various three-dimensional models of the anatomy.
Therefore, it will be understood that the implant may be positioned in any appropriate manner as discussed above, and the position of the implant may be confirmed in block 512. The confirmation of the position of the implant may be performed in any appropriate manner, such as with imaging the implant relative to a previous planned image or modeling the implanted anatomy or implant relative to a previous image. Regardless of the method used to confirm the position of the implant, the confirmed position of the implant may be done substantially intraoperatively to allow for a substantially precise placement of the implant and a correct surgical procedure.
The position, correct volume, geometry, and other appropriate considerations, of the implant may also be confirmed with a track-able probe or other instrument. The position of a probe may be determined by use of tracking sensors positioned relative to the probe that may be used to touch or determine the position of the implant. This allows determining a position of the implant without connecting tracking sensors directly to the implant. Tracking sensors, however, may be included in the implant to be tracked to ensure proper positioning of the implant.
After the position is confirmed by Yes in block 514, the patient may recover in block 516. It will be understood that the confirmation of positioning of the implant may result in a No in block 518 and an additional placing in block 492 occurs. Therefore, positioning the implant may be iterative until the decisions block 512 is Yes 514. Because the procedure was predetermined or preselected in block 426, the implant may substantially be in a position necessary to achieve selected results, such as a range of motion. Therefore, the confirmation in block 512 may simply assure the user that the implant has been positioned in the selected location.
In addition, the patient recovering in block 516 may be reduced due to the planning and reduced trialing. The planning procedure can help ensure that an implant that may achieve a selected result in a first instance rather than providing a plurality of trialing instruments to attempt to achieve a selected result. As discussed above, a selected volume of the anatomy may be removed substantially precisely using the planning and navigation systems. Then the implant may be selected to achieve a selected result, such as substantially precisely replacing the resected anatomical portion. Therefore, the trialing may be substantially reduced or eliminated. In addition, optionally, if the implant is not confirmed to be in a proper position then the implant may be repositioned or positioned again in block 492. Only after proper positioning of the implant or a confirmation thereof may the patient be removed from the operative theater. This may also reduce a need for a later procedure and assist in the recovering of the patient.
It will be understood that the above-described system may be used with any appropriate implants or for any appropriate implantation device or system. For example, a bladder or other container device may be positioned relative to a selected portion of the anatomy, such as between the two vertebrae 406, 408 to be filled with a material. Various systems may be used, such as those described in U.S. Pat. Nos. 6,443,988; 6,306,177; and International Publication No. WO97/26847, each incorporated herein by reference. The bladder may be positioned relative to a selected portion of the anatomy after the planning procedure has been determined and only a selected or determined volume of material is then positioned within the bladder. Therefore, the system may be used to preselect or predetermine the volume of fluid to be positioned in the bladder to allow for a selected result. Alternatively, other inflatable devices may include those disclosed in U.S. Pat. Nos. 6,663,647; 6,641,587; 6,623,505; 6,607,544; 6,423,083; 6,235,043; and 5,927,015, each incorporated herein by reference.
In addition, various materials may be injected relative to a selected portion of bone, such as bone cements and the like that may fill a selected void or volume. Again, as discussed above, a selected volume or bounds of material may be selected or determined to perform the procedure. Therefore, the procedure may be planned after determining a selected volume of fluid to be injected and then injecting the selected fluid. Various systems for positioning may include those described in U.S. Pat. Nos. 6,613,054 and 6,048,346, each incorporated herein by reference. Therefore, a selected area may be determined to include a selected volume and the procedure may be planned after determining a selected volume and positioning the selected volume may then be navigated with the system.
In addition, various other materials, such as various hydrogels or dehydrated hydrogel materials may be positioned relative to a selected portion of the anatomy. For example, an elastic, elastomeric, and/or hydrogel material may be injected into a selected portion of the anatomy. Various methods and systems may include those described in U.S. Pat. Nos. 5,800,549 and 5,534,028, each incorporated herein by reference.
Therefore, it will be understood that the system 400 may be used to determine a selected volume, size, geometry, and the like that can be filled with any appropriate implant. The system 400 can be used to plan a volume appropriate to be implanted and the procedure may then be performed according to the plan. In addition, as discussed above, the system may be used to position a selected material, such as bone morphogenic proteins, antibiotics, other medications, and other bioactive materials, relative to a selected portion of the anatomy and the system may be used to position the materials in a selected delivery device relative to the anatomy.
The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.
This application is a continuation-in-part of U.S. patent application Ser. No. 10/423,515 filed on Apr. 25, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 10/354,562 filed on Jan. 30, 2003. The disclosures of the above applications are incorporated herein by reference.
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| Number | Date | Country | |
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| 20040171924 A1 | Sep 2004 | US |
| Number | Date | Country | |
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| Parent | 10423515 | Apr 2003 | US |
| Child | 10794716 | US | |
| Parent | 10354562 | Jan 2003 | US |
| Child | 10423515 | US |
