INSTRUMENT BOURNE OPTICAL TIME OF FLIGHT KINEMATIC POSITION SENSING SYSTEM FOR PRECISION TARGETING AND METHODS OF SURGERY

Abstract

A medical devices en-vivo positional determination system using a plurality of optical time of flight (TDF) transceivers along with gyroscopic angular and mechanical distance sensors for the determination of absolute linear and angular positional information of the tool bit tip for the purposes of more accurate hand-held drilling or cutting, on the workpiece using forward kinematic equations calculated on a microcomputer to provide a real-time display of the 3-linear position and 2-angular orientation of the tool bit (such as a drill, scalpel, or wire driver).

Claims

1. A positional determination and guidance system to guide the user of a surgical tool having a terminal workpiece over time along a workpath in a patient's body from an initial start point to a determined end point and comprising: a base member which has a reference plane and which also supports a two-member robotic arm system comprising of a variable-length first arm which is comprised of a flexible link which extends at an angle a and can be extended by a value n from a first length to a second length and the first arm being fitted with a length sensor capable of determining the value n and the link being mounted in a known spatial relationship relative gimbal and fitted with at least one angular sensor capable of determining angle a, a hand-held tool serving as a second fixed-length arm which is connected to the first arm, and which has a plurality of angular sensors and a plurality of time of flight transceivers for absolute distance to a reference plane, a CPU having machine readable code to determine the progress of the terminal workpiece along the workpiece from the initial start point toward the determined end point, and a display that informs the user as to the guidance of the terminal workpiece along the workpath.

2. A positional determination and guidance system as set forth in claim 1, that uses a combination of radio frequency wireless communication and electrical communication via hard-wires between the hand-held tool and the base member.

3. A positional determination and guidance system as set forth in claim 2, including means to calculate a time of flight determination between the time of flight transceivers and the reference plane.

4. A positional determination and guidance system as set forth in claim 1, wherein the time of flight transceivers generate light pulses in the visible or near infrared spectrum for use in the guidance of the terminal workpiece.

5. A positional determination and guidance system as set forth in claim 3, wherein the positional information is provided through the use of angular measurements provided by MEMS IMU's used in conjunction with measured and known distances via the forward kinematics equations to determine the position and trajectory as a function of time.

6. A positional determination and guidance system as set forth in claim 3, wherein the combination of the forward kinematically derived positions and angles are compared to absolute distances and angles as determined by the time of flight transceivers mounted on the distal link.

7. A positional determination and guidance system as set forth in claim 3, wherein the forward kinematic equations in combination with the time of flight information is used by the CPU to perform calculations to derive the positional information and angular approach.

8. A positional determination and guidance system as set forth in claim 3, wherein the tool handle comprises the distal link.

9. A positional determination and guidance system as set forth in claim 1, wherein the time of flight transceiver is an optical time of flight transceiver.

10. A positional determination and guidance system as set forth in claim 7, wherein the time of flight transceiver is an optical time of flight transceiver.

11. A positional determination and guidance system for a surgical tool path determination as described in claim 1, further including video cameras to create video images and where the video images are also used simultaneously in the guidance of the terminal workpiece along the workpath.

12. A positional determination and guidance system as set forth in claim 1, including the further use of fluoroscopic imaging to derive the tool workpath determined end point.

13. A positional determination and guidance system as set forth in claim 1, wherein the accuracy of the guidance of the workpath to the determined end point is at least +/−1 mm.

14. A positional determination and guidance system as set forth in claim 1, wherein the accuracy of the guidance of the workpath to the determined end point is at least +/−2 degrees.

15. (canceled)

16. A surgical guidance system comprising a surgical drill including ultrasonic senders, a reference frame including receivers, a CPU having hardware including machine readable code to determine time of flight of an optical signal generated by an optical time of flight transceivers, and a visual display and feed-back system to inform the surgeon as to how to create a drill pathway through a reference frame which contains the subject patient body part.

17. A surgical system as set forth in claim 16, wherein the reference points for a pathway created by the surgical drill are obtained through digital images.

18. A surgical system as set forth in claim 16, wherein the reference points are captured using fluoroscopy.

19-49. (canceled)

50. A positional determination and guidance system to guide the user of a surgical tool having a terminal workpiece over time along a workpath in a patient's body from an initial start point to a determined end point and comprising: a base member which has a reference plane and which also supports a two-member robotic arm system comprising of a variable-length proximal arm which is comprised of a flexible and extensible cable-under-tension link fitted a cable-length sensor mounted on a 2-axis gimbal fitted with a plurality of angular sensors in a known spatial relationship relative to the initial start point, a hand-held tool serving as the second fixed-length distal arm, connected to the proximal arm by means of a 3-axis ball joint, and having a plurality of angular sensors and a plurality of time of flight transceivers for absolute distance to a reference plane, a CPU having machine readable code to determine the progress of the terminal workpiece along the workpiece from the initial start point toward the determined end point, and a display that informs the user as to the guidance of the terminal workpiece along the workpath.

51. A positional determination and guidance system as set forth in claim 50, that uses a combination of radio frequency wireless communication and electrical communication via hard-wires between the hand-held tool and the base member.

52. A positional determination and guidance system as set forth in claim 51, including means to calculate a time of flight determination between the transceivers and the reference plane.

53. A positional determination and guidance system as set forth in claim 50, wherein the transceivers generate light pulses in the visible or near infrared spectrum for use in the guidance of the terminal workpiece.

54. A positional determination and guidance system as set forth in claim 52, wherein the positional information is provided through the use of angular measurements provided by MEMS IMU's used in conjunction with measured and known distances via the forward kinematics equations to determine the position and trajectory as a function of time.

55. A positional determination and guidance system as set forth in claim 52, wherein the combination of the forward kinematically derived positions and angles are compared to absolute distances and angles as determined by the time of flight distance transceivers mounted on the distal link.

56. A positional determination and guidance system as set forth in claim 52, wherein the forward kinematic equations in combination with the time of flight information is used by the CPU to perform calculations to derive the positional information and angular approach.

57. A positional determination and guidance system as set forth in claim 52, wherein the tool handle comprises the distal link.

58. A positional determination and guidance system as set forth in claim, 52 wherein the time of flight sensor is an optical time of flight sensor.

59. A positional determination and guidance system as set forth in claim 56, wherein the time of flight sensor is an optical time of flight sensor.

60. A positional determination and guidance system for a surgical tool path determination as described in claim 50, further including video cameras to create video images and where the video images are also used simultaneously in the guidance of the terminal workpiece along the workpath.

61. A positional determination and guidance system as set forth in claim 50, including the further use of fluoroscopic imaging to derive the tool workpath determined end point.

62. A positional determination and guidance system as set forth in claim 50, wherein the accuracy of the guidance of the workpath to the determined end point is at least +/−1 mm.

63. A positional determination and guidance system as set forth in claim 50, wherein the accuracy of the guidance of the workpath to the determined end point is at least +/−2 degrees.

64. A positional determination and guidance system as set forth in claim 50, wherein the local and global coordinate systems are spatially registered and calibrated with one another using a combination of a 3-dimensional point-cloud fiducial and the use of the draw-wire touching the said 3-dimensional point-cloud fiducial, the C-arm source and scintillation target screen fiducials in order to place their relative (x, y, z) spatial locations relative to one another.

65. A positional determination and guidance system as set forth in claim 50, wherein the local and global coordinate systems are spatially registered and calibrated with one another using known intrinsic and extrinsic parameters of a C-arm X-ray camera and the use of two X-ray images taken with a translation and rotation of the C-arm such that the global and local frame of reference basis vectors are aligned to permit calculation of the location of a point on the 3-dimensional point-cloud fiducial using linear algebraic equations for ray tracing of a pinhole camera model.

66. A positional determination and guidance system to guide the user of a surgical tool having a terminal workpiece over time along a workpath in a patient's body from an initial start point to a target end point and comprising: a fluoroscope having a C-arm and means to register a set of C-arm coordinates, a base member which has a reference plane at a known location relative to the set of C-arm coordinates and which also supports a two-member robotic arm system comprising of a variable-length proximal arm which is comprised of a flexible and extensible cable-under-tension link fitted a cable-length sensor mounted on a 2-axis gimbal having a frame of reference and fitted with a plurality of angular sensors in a known spatial relationship relative to the initial start point, a hand-held tool serving as the second fixed-length distal arm, connected to the proximal arm by means of a 3-axis ball joint, and having a plurality of angular sensors and a plurality of time of flight transceivers for absolute distance to a reference plane, a plurality of fiducials which are capable of providing the set of C-arm coordinates and wherein the fiducials are used to find a translation vector needed to translate the target end point into the gimbal FOR and to find a rotation to define and align at least one C-arm vector with the translation vector of the gimbal, a CPU having machine readable code to determine the progress of the terminal workpiece relative to the C-arm coordinates along the workpiece from the initial start point toward the determined end point, and a display that informs the user as to the guidance of the terminal workpiece along the workpath.

67. A positional determination and guidance system as set forth in claim 66, including means to calculate a time of flight determination between the transceivers and the reference plane.

68. A positional determination and guidance system as set forth in claim 66, wherein the transceivers generate light pulses in the visible or near infrared spectrum for use in the guidance of the terminal workpiece.

69. A positional determination and guidance system as set forth in claim 68, wherein the positional information is provided through the use of angular measurements provided by MEMS IMU's used in conjunction with measured and known distances via the forward kinematics equations to determine the position and trajectory as a function of time.

70. A positional determination and guidance system as set forth in claim 68, wherein the combination of the forward kinematically derived positions and angles are compared to absolute distances and angles as determined by the time of flight distance transceivers mounted on the distal link.

71. A positional determination and guidance system as set forth in claim 68, wherein the forward kinematic equations in combination with the time of flight information is used by the CPU to perform calculations to derive the positional information and angular approach.

72. A positional determination and guidance system as set forth in claim 68, wherein the tool handle comprises the distal link.

73. A positional determination and guidance system as set forth in claim 68, wherein the time of flight sensor is an optical time of flight sensor.

74. A positional determination and guidance system as set forth in claim 71, wherein the time of flight sensor is an optical time of flight sensor.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG. 1 shows a schematic diagram of the preferred embodiment of the present invention;

[0028] FIG. 2 shows a schematic diagram of the principle of operation;

[0029] FIG. 3 shows a block diagram of the electronic system;

[0030] FIG. 4 shows a block diagram of the steps and sequence used to acquire and derive the distances and angles from the sensor data that are generated and collected;

[0031] FIG. 5 shows a photograph of a prototype of one embodiment of the present invention reduced to practice;

[0032] FIG. 6 shows a photograph of the prototype of the present invention reduced to practice with a detail showing the internal electronics in the base of the tool handle;

[0033] FIG. 7 shows a photograph of the invention reduced to practice and held in a hand to demonstrate the ergonomic aspects;

[0034] FIG. 8 shows a 3-dimensional point-cloud fiducial reference system for registering the present invention's coordinate axis system with the global coordinate axis system;

[0035] FIG. 9 shows a schematic representation of the 3-dimensional point-cloud fiducial reference system with the present invention and its use to register the spatial coordinate system of the X-ray C-arm and operating room coordinate system; and

[0036] FIG. 10 shows a 3-dimensional perspective view of a C-arm X-ray machine with the present invention and the associated local and global coordinate systems.

DETAILED DESCRIPTION OF THE INVENTION

[0037] In the preferred embodiment of the present invention as shown by the schematic diagram in FIG. 1, a tool driver 10, fitted with struts (supporting rods) 13 that serve to hold at least three OTOF transceiver at the top 14, left 15, and right 16 positions. The tool driver has a tool bit (k wire, drill, scalpel, etc.) 17, which has a distal tip 18 which corresponds to the spatial positional information shown in the display 47. The transceivers 14, 15, 16 (e.g., Sparkfun VL53LOX) are in optical communication with an optically reflecting flat base 2. These optical transceivers are optically linked to a rigid base plate 2 that serves to locate the transmitters with respect to the workpath in the surgical environment in the patient's body part 4 subject to the procedure, to guide the tool tip 18 through an aperture 6 in the base 2, along the workpath 5, towards the target 3. The OTOF transceivers, IMU 19, are in direct or indirect electrical communication with an electronic microcontroller unit #1 (MCU #1) 11 to a controller PC (or “CPU”, i.e., a computer processing unit), 46 via physical wiring cable or by radio frequency electronic transmission, such as Xbee or Bluetooth via RF transceivers 20 and 44 via antennas 22 and 45 and MCU #2 43. A draw-wire encoder 40 mounted on a rotating 2-axis gimbal mount 41 and physically linked through a flexible and extensible link, such as a mechanical tape, wire, rod, or most preferably cable 48 between the draw-wire encoder 40 and the tool handle 10, provides the absolute mechanical distance from a fixed reference mechanical ground point 1 to the target 3. The draw-wire encoder 40 also is fitted with an NU #2 42 to provide the azimuth and elevation angles that are transmitted to the MCU #2 43 via wires and then to a PC controller 46 which performs calculations in software to fuse the data generated by the OTOF sensors, the two IMUs, and the draw-wire sensor into a real-time display of the positional information for the surgeon to use as feedback of the tool tip 18 position. Together, these components shown in FIG. 1 form the basis of the present invention's preferred embodiment that utilizes the measurement of the TOF (“Time of Flight”) of a light pulse from the transceivers 14, 15, and 16. By use of geometrical relationships, the fixed distances between the individual receivers and transmitters, and the speed of light, the angles of the OTOF relative to the draw-wire axis 42, the precise distances between the spatially separated transmitters and receivers can be determined with a closed form equation calculated either in the MCU #1 43, the computer 46, or even through use of a microcontroller MCU #1 11 in the tool driver 10 itself and then displayed on the screen 47. In this sense, the system can be predictive of the continued course of the tool-tip along the workpath, although, it should be understood that the system tracks the position and displays it in near-real time during use.

[0038] FIG. 2 schematically illustrates the principle of operation of the present invention. Here, the drill handle 10 along with drill shaft 17, draw-wire sensor 40, IMU #1 19 and IMU #2 42 form a completely deterministic 2-link mechanical linkage system described by the so-called forward kinematic equations that are used for traditional serial link robotic arm analysis. Here, in FIG. 2, the arms have rotating joints located at 43 and 41 are free to move in elevation θ 51 and azimuth φ 52 at the gimbal joint 41 and in elevation θ′ 54 and azimuth φ′ 55 at the ball-joint attachment point 43. The elevation and azimuthal angles are provided by the IMU's 19 and 42 which are fitted with micro-electro-mechanical systems (MEMS) gyroscopes, accelerometers and magnetometers to effect angular measurements with 0.02 deg accuracy and essentially zero angular drift. In FIG. 2, the knowledge of the variable length L of the draw-wire 53, plus the distance from the drill tip 18, to the ball joint 43, plus the elevation and azimuthal angles at each joint as described above, completely describes the position of the tip 18, relative to the target T point 3 at (x,y,z).sub.T, and its trajectory as described by a vector transecting the points B at (x,y,z).sub.B and T at (x,y,z).sub.T. The position of any point in a serial chain of links can be described a transformation matrix as described by the so-called Denavit-Hartenberg parameters described elsewhere by Hartenberg and Denavit (1964). The OTOF distance sensors mounted on the drill handle are located at a distance R 57 from a reference plane 2 that is mechanically fixed to the patient 4 with target T 3, with both the patient 4, the reference plane 2, the gimbal 41 are all mechanically grounded to the reference frame 1. In this way, the relative position of the drill tip P 18 located at (x,y,z).sub.P and the target T 3 located at (x,y,z).sub.T relative to the gimbal origin point G 41 located at (x,y,z).sub.G are always known via the forward kinematic equations plus the absolute distance from the point B (x,y,z).sub.B to the reference plane 2 are also know to permit a redundant measurement of distance for error checking. Note that through the use of three OTOF sensors, the angle of the drill vector 17 relative to the reference plane 2 is also known and this provides a redundant measurement of the angle of approach as measured from the NU sensors.

[0039] FIG. 3 shows a schematic block diagram of the electronics and their interconnections for the present invention. The tool driver 10 shown by the dashed box contains the following electronic components which when connected, provide a measurement of the distances from the OTOF sensors 14, 15, 16 which are multiplexed through a MUX 23, and the angular orientation data provided by the IMU #1 19 which are all fed to a MCU #1 11 connected to a wireless RF transceiver link #1 20 fitted with an antenna #1 22. All components in the tool driver 10 are powered by a battery 12.

[0040] The battery can be rechargeable or of the primary type. The antenna 22 transmits the data in the drill handle 10 via an RF link 48, to a second RF link #2 44 also fitted with an antenna #2 45. The RF link #2 45 then sends the wireless data from the tool driver 10 to a second MCU #2 43 which also collects data from draw-wire base 41 which contains the draw-wire encoder 40, and the IMU #2 42, and all these data are then processed and fused together via a software program (such as MATLAB or Python) in a PC computer 45 via a USB link 49. It is also possible to replace MCU #2 43 with a more powerful MCU or a single board computer (SBC) to affect the calculations performed in the PC 46. The final positional information and angular data are then presented to the operator via display screen 47.

[0041] FIG. 4 shows a block diagram of the top level software steps used to calculate and derive the spatial measurement using the system depicted in FIG. 1. In the first Step 101, the MATLAB program initializes the serial communications interfaces between all of the interconnected devices, and in Step 102, the MCU's accepts an identification number and starts the program. In Step 103, the MATLAB program sends a Mode 1 or Mode 2 depending on whether or not the program is starting and being initialized. In the case of a start of initialization, Mode 1 is selected which then initialized all of the arrays in the MCU's in Step 105. Once that is done, Mode 2 is selected by the MATLAB program in Step 106 and the MCU's record the orientation and raw distance data from the sensors, whereupon the MCU sends the parameters to the MATLAB program via a serial link in Step 108. In Step 109, the MATLAB program stores the values in a matrix, and these are used in the matrix transformation in Step 110 as described by the so-called forward kinematic equations. The MATLAB program then plots the link lengths and trajectories in a graphical user interface (GUI) in Step 111, whereupon the distances and angle inputs are then graphed on the GUI in Step 112. Depending on whether more data is needed or the sensors need to be stopped in Step 113, the MATLAB program sends a Mode 2 Step 114 to continue the measurement cycle or a Mode 3 in Step 115 to shutdown and stop the program execution in Step 116.

[0042] FIG. 5 shows a photograph of the prototype of the present invention as reduced to practice. In FIG. 5, there are notations showing the locations of the OTOF sensors, the IMU #1, IMU #2, the draw-wire encoder, the gimbal base, and the drill handle base with electronics mounted inside.

[0043] FIG. 6 shows another photograph of the present invention as reduced to practice but shown from a different perspective for better clarity. Of note is a detail of the drill handle base with the cover removed to show the MCU #1 inside.

[0044] FIG. 7 shows another photograph of the present invention as reduced to practice but being hand-held to show the relative positioning of an example of where the draw-wire encoder is located and how the gimbal mount allows the draw-wire orientation to be determined with an IMU #2 mounted in the gimbal head.

[0045] Analysis of the theoretical best accuracy of the positional determination using a first order angular resolution and moment-arm approach with the measured standard deviations from the IMU angular sensors (+/−0.02 deg) and variable length link arm from the draw-wire sensor (+/−0.5 mm), yields an approximate overall positional uncertainty in radial distances (x,y) of the drill tip to be +/−0.33 mm and axial distance (z) of the drill tip to be +/−0.71 mm. The present prototype embodiment is illustrated having relatively low-tolerance, non-rigid 3d printed plastic mounts used for the mechanical linkages, however, these will be replaced with precision low-backlash machined metal joints, to improve accuracy and to tend towards the theoretical limits shown above.

[0046] Analysis of the angular uncertainties of the IMU sensors yields and approximate angular uncertainty of +/−0.03 degrees in elevation (pitch) and azimuth (yaw).

[0047] FIG. 8 shows a 3-dimensional point-cloud fiducial base 400 that can have, for example, the shape of a cube with precision-depth bored holes 405 which support a plurality of metal spheres 406 of various diameters. At minimum, 3 spheres are required, with typically 8 to 12 spheres being desirable for the accurate calculation of the coordinate system position and orientation via a plurality of orthogonal X-ray images. The sphere positions are strategically chosen as pseudo-random (x, y, z) coordinates in such a way that their X-ray projections at two orthogonal axis do not occlude each other. Three of the spheres, preferably of the smallest diameter circa 2 mm are located on the bottom face of the fiducial cube at the (0, 0, 0), (100 mm, 0, 0) and (0, 0, 100 mm) positions to establish a reference frame with which to register against a flat reference surface representing the global coordinate system frame. A global coordinate system or frame of reference is defined as the frame of reference of the operating room as connected to the earth's surface. The local coordinate system or frame of reference is defined as the coordinate system associated with just the mechanical base 1 of the present invention. The metal spheres 406 have various diameters (e.g., 2 mm, 3 mm, 4 mm, 5 mm) to aid in the identification of the orientation relative to a known arrangement within the cube. The cube should have a visual indicator 404, such as one corner that is not bored as a visual index for the user to place with a known orientation. Each sphere inside the fiducial base is at a precisely known position and these position coordinates can be used with fluoroscopy using a C-Arm apparatus as shown in FIG. 9.

[0048] In FIG. 9, the fiducial cube 400 is resting against a known reference plane 2 and the fiducial cube 400 is completely within the field of view of the X-ray cone 505 produced by the C-arm X-ray source 501. The X-ray cone 505 transects the fiducial cube 400, the patient 4 with desired target point 3, and projects the X-ray image onto the C-arm X-ray scintillation screen 506. The C-arm is anchored to the operating room global frame of reference 500, while the gimbal 41 and reference plane 2 are anchored to a local mechanical reference frame 1. By using the draw-wire 53 and gimbal base 41 to touch various points 502, 503, and 504, the relative positions and orientation of the C-arm, the reference frame mechanical ground 1, global reference frame ground 500, and the patient 4, can all be registered and linked together in a single solid body coordinate system. Note that a minimum of 3 registration touch points are needed at each location 502, 503, and 504 to uniquely establish the 3-dimensional position and orientation of that part. By rotating the C-arm source 501 and scintillation screen 506 together and capturing at minimum, two orthogonal projections, the positions of the fiducial spheres in the point cloud base 400, can be uniquely established via linear algebraic methods as described by Brost et al. (2009).

[0049] FIG. 10 shows an X-ray C-arm system comprised of an X-ray source 501 and X-ray scintillation detector plate 506 with an iso-center 510 and global frame of reference 512, with a 3-dimensional fiducial point-cloud cube 400 with local frame of reference 511. The drill handle 10, target point 3, and reference frame mechanical ground base 1 are also show. As previously stated, the target 3, and the 3-dimensional fiducial 400 must be within the field of view of the X-ray beam path and the scintillation detector screen 506. In order to locate the target 3 which has been selected in the X-ray images, we locate the fiducial 400, which is attached rigidly to the reference frame 1, which is also attached the gimbal 40 (not shown) of the present invention as shown in FIG. 1 but omitted here for visual clarity, and whose position is known in the local coordinate frame 511 of the gimbal 40, in the global coordinate frame of the C-arm 512. The coordinate transform we are looking to calculate is .sup.C-ARMξ.sub.GIMBAL.

[0050] Note that there is an assumption that the system has been calibrated so that the intrinsic parameters (pixel spacing of the detector, the distance between the X-ray source and detector plane, location of the iso-center of the C-arm) are accurate and extrinsic parameters can be measured with suitable accuracy. To locate a point one needs the intrinsic and extrinsic C-arm camera parameters. As given in (Brost, et al., 2009), the camera model can be taken to be a Pinhole Camera model, with a projection matrix given by:

P=K[R|t]  (1)

The intrinsic parameters K of the X-ray “camera” can be evaluated as:

[00001]$\begin{array}{cc}K=\left[\begin{array}{ccc}\frac{\mathrm{SID}}{p}& & o_x\\ & \frac{\mathrm{SID}}{p}& o_y\\ & & 1\end{array}\right]& \left(2\right)\end{array}$

Where

[0051] SID is source to image detector distance [0052] p is the distance between pixels in mm [0053] o.sub.x is the x location of the projected iso-center in pixels on the image [0054] o.sub.y s the y location of the projected iso-center in pixels on the image

[0055] The Extrinsic Parameters are given by the two rotations R.sub.α and R.sub.β and a translation t, where t is the translation from the X-ray source to the iso-center of the C-arm. Note that in (Brost, et al., 2009) the rotation matrix given as R.sub.α is clockwise positive about the Z axis, and R.sub.β is clockwise positive about the x-axis. In addition, the axes are aligned with the DICOM patient axes (LPS, X goes from Patient right to patient left, Y goes from patient Anterior to Posterior, and Z goes from Patient Anterior to Superior.)

The rotations are combined into a matrix R given by:

R=R.sub.α.Math.R.sub.β  (3)

From equation 1, we can project a global point w∈R.sup.3 to v∈R.sup.3 where v is a homogenous point in 2d space and w is a homogenous point with 1 as the fourth component. The projection can be written as:

v.sub.α,β=K(R.Math.w+t)  (4)

To solve for the global C-arm points:

w=R.sup.−1.Math.(K.sup.−1.Math.v.sub.α,β−t)  (5)

The 3-dimensional fiducial 400 in C-arm global coordinates 512 can be used to find the translation vector needed to translate the target 3 position into the gimbal 40 frame of reference 511. This is comprised of a translation followed by a rotation to bring the C-arm basis vectors 512 aligned with the gimbal 40 frame of reference basis vectors 511. In this way, multiple angle (>2) projections of the 3-dimensional fiducial are not needed to register the two frames of reference together, as when performing the registration using a multi-angle computed tomographic (CT) reconstruction technique.

[0056] 19. A surgical targeting system guided by time of flight sensors strategically mounted on a hand-held or potentially robotic drill, the time of flight sensors being in proximity to x-ray opaque fiducials positioned relative to a subject surgical area located within a defined three dimensional reference frame and wherein the x-ray opaque fiducials are point cloud fiducials using pseudorandom locations used with a deconvolution to establish a global reference XYZ coordinate system in the three dimensional reference frame, and a CPU hardware and software to determine the proximity in space of the associated time of flight sensors as they change course over time.

[0057] 20. A surgical targeting system as set forth in 19, wherein a surgical pathway is determined by a user and includes a drill entry point and an end point and where the drill entry point and the end point are selected by the user and entered into a computer.

[0058] 21. A surgical targeting system as set forth in 19, wherein the receiver is a wideband microphone.

[0059] 22. A surgical targeting system as set forth in 19, wherein the optical time of flight transceiver uses a light emitting diode.

[0060] 23. A surgical targeting system as set forth in 19, wherein the optical time of flight transceiver uses a laser diode.

[0061] 24. A surgical targeting system as set forth in 23, wherein the optical time of flight transceiver uses optical heterodyne modulation to determine the time of flight through an optical phase measurement.

[0062] 25. A surgical targeting system as set forth in 23, wherein the optical time of flight transceiver uses triangulation to determine the distance through optical geometric measurement.

[0063] 26. A surgical targeting system as set forth in 25, wherein further comprising a precision virtual reality system for remote surgery.

[0064] 27. A surgical targeting system as set forth in 19, wherein an offset is used to account for detection of wave inversion.

[0065] 28. A surgical targeting system as set forth in 27, the offset is based on one or more of the wave number, the microphone displacement, and the transmitter or receiver foci.

[0066] 29. A three-dimensional aiming system to determine an angle of incline of a terminal workpiece carried by a tool along a workpath from an initial start point to a determined end point and comprising: a two arm linkage which links the terminal workpiece to a fixed point wherein the first arm is an extendable link which can be extended a value n which can be determined and the second arm is a fixed length arm which incorporates the tool, a frame of reference which includes a plurality of senders that define two orthogonal planes and which can be used to establish a set of coordinates for the workpath, a plurality of sensors carried by the tool and in communication with the senders, a CPU having machine readable code to determine the alignment of the terminal workpiece relative to the set of coordinates, and a display that informs the user as to the alignment.

[0067] 30. A three-dimensional aiming system as set forth in 29, wherein the senders and sensors are acoustic or light.

[0068] 31. A three-dimensional aiming system as set forth in 30, further including means to calculate a time of flight determination between the senders and sensors.

[0069] 32. A three-dimensional aiming system as set forth in 29, wherein the optical time of flight sensors use visible to near infrared (400 nm to 800 nm) light to sense the distance from the tool to the reference plane.

[0070] 33. A three-dimensional aiming system as set forth in 32, wherein the senders generate an acoustic signal which is received by the acoustic receivers and a Fast Fourier Transform (FFT) is used by the CPU to extract phase information from the received acoustic signal in order to derive the time of flight.

[0071] 34. A three-dimensional aiming system as set forth in 32, wherein the senders are acoustic transmitters that generate an acoustic pulse signal which is received by the sensors which are acoustic receivers which receive a received pulse signal and a discrete Cross Correlation Function (CCF) between the transmitted acoustic pulse signal and the received pulse signal is used by the CPU to derive the time of flight.

[0072] 35. A three-dimensional aiming system as set forth in 31, wherein the digital signal processing (DSP) is used by the CPU to perform calculations to derive the time of flight.

[0073] 36. A three-dimensional aiming system as set forth in 31, wherein the senders generate both a carrier at a carrier frequency and an acoustic pulse signal which is received by the sensors as a received pulse signal and wherein digital coding schemes are used to modulate the carrier frequency in order to increase a contrast and signal to noise ratios to improve an accuracy of a derivation of the time of flight.

[0074] 37. A three-dimensional aiming system as set forth in 36, wherein the digital coding scheme is a AA55 code.

[0075] 38. A three-dimensional aiming system as set forth in 37, wherein an Octave code scheme having a routine is used to automatically extract a phase reversal or an inflection point for the derivation of the time of flight.

[0076] 39. A three-dimensional aiming system as set forth in 29, further including a video camera to create video images and where the video images are also used simultaneously to aim the terminal workpiece.

[0077] 40. A three-dimensional aiming system as set forth in 29, including the further use of fluoroscopic imaging to derive the tool workpath determined end point.

[0078] 41. A three-dimensional aiming system for positional determination and guidance system as set forth in 29, wherein the accuracy of the guidance of the workpath to the determined end point is at least +/−1 mm.

[0079] 42. A three-dimensional aiming system as set forth in 29, wherein the accuracy of the alignment of the terminal workpiece is at least +/−2 degrees to the set of coordinates.

[0080] 43. A hand-held orthopedic instrument which is a drill or wire driver having a three-dimensional aiming system to determine an angle of incline of a terminal workpiece for a surgical tool along a workpath in a patient's body from an initial start point to a determined end point and comprising: a two arm linkage which links the terminal workpiece to a fixed point wherein the first arm is an extendable link which can be extended a value n which can be determined and the second arm is a fixed length arm which incorporates the orthopedic instrument, a frame of reference which includes a plurality of senders that define two orthogonal planes and which can be used to establish a set of coordinates for the workpath, a plurality of sensors carried by the tool and in communication with the senders, a CPU having machine readable code to determine the alignment of the terminal workpiece relative to the set of coordinates, and a display that informs the user as to the alignment.

[0081] 44. A hand-held orthopedic instrument which is a drill or wire driver having a three-dimensional aiming system to determine an angle of incline of a terminal workpiece for a surgical tool along a workpath in a patient's body from an initial start point to a determined end point and comprising: a two arm linkage which links the terminal workpiece to a fixed point wherein the first arm is an extendable link which can be extended a value n which can be determined and the second arm is a fixed length arm which incorporates the orthopedic instrument, a frame of reference which includes a plurality of senders that define two orthogonal planes and which can be used to establish a set of coordinates for the workpath, a plurality of sensors carried by the tool and in communication with the senders, a CPU having machine readable code to determine the alignment of the terminal workpiece relative to the set of coordinates, and a haptic feedback member that informs the user as to the alignment.

[0082] 45. A method of performing a surgery comprising, the steps of: locating and securing an anatomical area within a three-dimensional reference frame capable of establishing a coordinate system, using x-ray opaque fiducials on the anatomical area to locate points in the coordinate system wherein the -ray opaque fiducials are point cloud fiducials which use pseudorandom locations with a deconvolution to establish a global reference XYZ coordinate system in the three-dimensional reference frame, using an imaging system to define an endpoint spaced from a starting point within the anatomical area and linking the endpoint to the coordinate system to form a set of desired alignment coordinates, providing a CPU having machine readable code and an instrument having a workpiece, and which bears a sender or receiver which are in communication with a corresponding sender or receiver operable with respect to the reference frame and with the CPU to determine a position of the workpiece in the reference frame, and aligning instrument by hand in the reference frame such that the alignment of the workpiece corresponds to the desired alignment coordinates.

[0083] 46. A method of performing a surgery comprising, the steps of: locating and securing an anatomical area within a three-dimensional reference frame capable of establishing a coordinate system, using x-ray opaque fiducials on the anatomical area to locate points in the coordinate system wherein the -ray opaque fiducials are point cloud fiducials which use pseudorandom locations with a deconvolution to establish a global reference XYZ coordinate system in the three-dimensional reference frame, using an imaging system to define an endpoint spaced from a starting point within the anatomical area and linking the endpoint to the coordinate system to form a set of desired alignment coordinates, providing a CPU having machine readable code and an instrument having a workpiece, and which bears a sender or receiver which are in communication with a corresponding sender or receiver operable with respect to the reference frame and with the CPU to determine a position of the workpiece in the reference frame, and wherein the instrument includes a two arm linkage which links the workpiece to a fixed point at a known location relative to the three-dimensional reference frame and wherein the first arm is an extendable link which can be extended a value n which can be determined and the second arm is a fixed length arm which incorporates the orthopedic instrument, and aligning instrument progressively and over time by hand in the reference frame such that the alignment of the workpiece corresponds to the desired alignment coordinates.

[0084] 47. A method of training or performing a surgery by a user of hand-held instrument and comprising, the steps of: locating and securing an anatomical area within a three-dimensional reference frame capable of establishing a coordinate system, using an imaging system to define an endpoint spaced from a starting point within the anatomical area and linking the endpoint to the coordinate system to form a set of desired alignment coordinates, using x-ray opaque fiducials on the anatomical area to locate points in the coordinate system wherein the -ray opaque fiducials are point cloud fiducials which use pseudorandom locations with a deconvolution to establish a global reference XYZ coordinate system in the three-dimensional reference frame, providing a CPU having machine readable code and the hand-held instrument having a workpiece, and which bears a sender or receiver which are in communication with a corresponding sender or receiver operable with respect to the reference frame and with the CPU to determine a position of the workpiece in the reference frame, and wherein the instrument includes a two arm linkage which links the workpiece to a fixed point at a known location relative to the three-dimensional reference frame and wherein the first arm is an extendable link which can be extended a value n which can be determined and the second arm is a fixed length arm which incorporates the orthopedic instrument, aligning instrument by the hand in the reference frame such that the alignment of the workpiece corresponds to the desired alignment coordinates, and alerting the user as to the location of the instrument relative to the desired alignment coordinates.

[0085] 48. A method of performing a hip fixation surgery using a wire driver comprising, the steps of: locating a hip within a three-dimensional reference frame capable of establishing a coordinate system, using an imaging system to define an endpoint in a femoral head of the hip spaced from a starting point on the proximal femur within the hip and linking the endpoint to the coordinate system to form a set of desired alignment coordinates, providing a CPU having machine readable code and a wire driver having a guide wire, and which bears a sender or receiver which are in communication with a corresponding sender or receiver operable with respect to the reference frame and with the CPU to determine a position of the guide wire in the reference frame, aligning the wire driver in the reference frame such that the alignment of the wire corresponds to the desired alignment coordinates, driving the wire using the wire driver, and seating a cannulated screw over the wire driver.

[0086] 49. A method of performing a hip fixation surgery as set forth in 48, wherein the wire driver includes a two arm linkage which links the workpiece to a fixed point at a known location relative to the three-dimensional reference frame and wherein the first arm is an extendable link which can be extended a value n which can be determined and the second arm is a fixed length arm which incorporates the orthopedic instrument.

[0087] In accordance with the patent statutes, the best mode and preferred embodiment have been set forth; the scope of the invention is not limited thereto, but rather by the scope of the attached claims.