Computer assisted targeting device for use in orthopaedic surgery

• US 6,285,902 B1
• Filed: 02/10/1999
• Issued: 09/04/2001
• Est. Priority Date: 02/10/1999
• Status: Expired due to Term

• Current Assignee: Stryker European Holdings I, LLC (Stryker Corporation)
• Original Assignee: Surgical Insights, Inc.
• Inventors: Kienzle, Thomas C. III, Lea, Jon T.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): MANTIS MERCADER, ELENI M
• Application Number:
  US09/248,133
• Time in Patent Office: 937 Days
• Field of Search: 600/426, 600/427, 606/130, 356/141.1, 356/375, 378/20, 378/205, 378/206, 378/207, 378/21, 128/849, 128/853, 128/856
• US Class Current: 600/427
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/1721 for applying pins along or parallel to the axis of the femoral neck
• CPC Class Codes: A61B 2017/00207 with hand gesture control or hand gesture recognition
• CPC Class Codes: A61B 2017/00902 transparent or translucent
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2068 using pointers, e.g. pointers having reference marks for determining coordinates of body points
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3916 Bone tissue
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/4233 using matrix detectors
• CPC Class Codes: A61B 6/4405 the apparatus being movable or portable, e.g. handheld or mounted on a trolley
• CPC Class Codes: A61B 6/4423 related to hygiene or sterilisation
• CPC Class Codes: A61B 6/547 : involving tracking of position of the device or parts of the device
• CPC Class Codes: A61B 6/548 : Remote control of the apparatus or devices
• CPC Class Codes: A61B 6/583 : using calibration phantoms
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras

Abstract

An image guided surgery system to enable a surgeon to move a surgical tool into a desired position relative to a body part is provided. The system works by accurately superimposing representations of the tool being used in the surgical field over images of the body part such that real-time tool position feedback is provided to the surgeon. The system uses a fluoroscopic x-ray device to generate two-dimensional body part images, a localizing device to determine the poses of surgical tools and the x-ray device, mathematical modeling of the imaging chain of the x-ray device, and a means for displaying the images of the body part superimposed with representations of the surgical tools. A related feature is the use of a digital flat-panel x-ray imager that employs a regular array of sensors to convert incident x-ray energy to a computer readable image, thereby permitting the fluoroscopic x-ray device to be used in any orientation without being affected by distortions due to local magnetic fields.

Claims

1. An image surgery system to enable a surgeon to move one or more surgical tools into a desired pose relative to a body part, comprising:

an imaging device for generating a plurality of two-dimensional images of the body part, said imaging device including an x-ray generator and a flat panel x-ray imager;

at least one surgical tool;

a localizing device for measuring the pose of the surgical tool relative to the imaging device; and

means for displaying representations of the surgical tool relative to the two-dimensional images of the body part.

2. The image guided surgery system of claim 1 wherein the imaging device is a C-arm fluoroscope.

3. The image guided surgery system of claim 1 wherein the flat panel x-ray imager is integral to the imaging device.

4. The image guided surgery system of claim 3 wherein the localizing device is an optical localizer and the imaging device is further outfitted with three or more localizing emitters, and the positions of said localizing emitters are measured by the optical localizer.

5. The image guided surgery system of claim 4 further comprising a sterile plastic drape, a section of the drape being adapted to cover a part of the imaging device containing localizing emitters, a portion of that section of the drape further adapted to fit flush and flat against the localizing emitters.

6. The image guided surgery system of claim 3 wherein the localizing device is an optical localizer and three or more localizing emitters are mounted in a housing that is attached to the imaging device, and the positions of said localizing emitters are measured by the optical localizer.

7. The image guided surgery system of claim 1 wherein the flat panel x-ray imager includes a housing attached to the imaging device.

8. The image guided surgery system of claim 7 wherein the localizing device is an optical localizer and the housing is further outfitted with three or more localizing emitters whose positions are measured by the optical localizer.

9. The image guided surgery system of claim 8 further comprising a sterile plastic drape, a section of the drape being adapted to cover a part of the flat panel x-ray imager housing having the localizing emitters affixed thereto, a portion of that section of the drape further adapted to fit flush and flat against the localizing emitters.

10. The image guided surgery system of claim 9 wherein the portion of the sterile drape fitting flush and flat against the localizing emitters is similar in dimension to the housing containing the emitters.

11. The image guided surgery system of claim 10 further wherein the housing is part of the imaging device.

12. The sterile drape of claim 9 further comprising a retaining ring that holds the drape against the housing and causes the drape to fit flush and flat against the localizing emitters.

13. The image guided surgery system of claim 1 wherein the localizing device is an electromagnetic localizer.

14. The image guided surgery system of claim 1 further comprising:

a second surgical tool, and the pose of said second surgical tool is measured by the localizing device; and

means for displaying a representation of the surgical tool relative to a representation of the second surgical tool independent of the images.

15. The image guided surgery system of claim 14 wherein either the surgical tool or the second surgical tool may be attached in a fixed and known relationship to an implant or other object.

16. The image guided surgery system of claim 14 wherein an axis of the surgical tool is to be aligned along a line between a point on the surgical tool and a reference point on the second surgical tool, and wherein a picture plane is defined that is perpendicular to said line and contains the reference point of the second surgical tool, and wherein alignment representations corresponding to the reference point on the second surgical tool and the intersection of said axis of the first surgical tool with the picture plane are displayed, such that the alignment representations are aligned when said axis of the surgical tool passes through the reference point of the second surgical tool.

17. The image guided surgery system of claim 1 further comprising:

a tracking device comprising a tracked portion and a means for attaching to the body part to be operated upon;

means for determining the motion of the tracking device in the plane of each two-dimensional image; and

means for translating and rotating superimposed representations of surgical tools relative to each two-dimensional image to match the motion of the tracking device.

18. The image guided surgery system of claim 17 wherein the attaching means is a clamp.

19. The image guided surgery system of claim 17 wherein the attaching means is a plurality of screws.

20. The image guided surgery system of claim 17 wherein movement of the tracking device greater than a predetermined magnitude results in an error condition being signaled to the surgeon.

27. The image guided surgery system of claim 2 wherein the imaging model parameters comprise conic projection model parameters and the first means for determining said conic projection model parameters comprises:

a calibration grid having markers disposed in fixed and known locations, visible in x-ray images; and

means for determining the pose of the calibration grid relative to either the x-ray source or x-ray receiver;

wherein the calibration grid is held in one or more poses between the x-ray source and x-ray receiver.

21. An image guided surgery system comprising:

an imaging device having an x-ray source and an x-ray receiver for generating a plurality of two-dimensional images of a body part;

a localizing device for determining the three-dimensional poses of the imaging device and a surgical tool;

an imaging model with imaging model parameters for modeling the projection and mapping of points in the x-ray beam of the imaging device to the images wherein the imaging model parameters are dependent on the pose of the imaging device;

first means for determining first imaging model parameters while the imaging device occupies a pose;

storage means for storing a set of the first imaging model parameters and corresponding imaging device pose for a plurality of imaging device poses;

second means for determining second imaging model parameters corresponding to a given pose of the imaging device and calculated from the set of first stored imaging model parameters and corresponding imaging device poses;

wherein the imaging model and the second imaging model parameters for the given pose permit accurate superposition of a representation of the surgical tool on the images of the body part.

22. The image guided surgery system of claim 21 wherein the imaging device is a C-arm fluoroscope.

23. An image guided surgery system of claim 22 wherein the x-ray receiver is a flat panel imager and the imaging model parameters comprise conic projection model parameters and the set of first imaging model parameters comprise a set of first conic projection model parameters wherein appropriate second conic projection model parameters for a given pose during surgery are calculated by interpolation of a subset of the set of first conic projection model parameters.

24. The image guided surgery system of claim 21 wherein the x-ray receiver comprises a flat panel x-ray imager.

25. The image guided surgery system of claim 24 wherein the flat panel imager is integral to the imaging device.

26. The image guided surgery system of claim 24 wherein the flat panel x-ray imager is contained in a housing and said housing is attached to the imaging device.

28. The image guided surgery system of claim 21 wherein the first means for determining the first imaging model parameters comprises:

a calibration grid having markers disposed in fixed and known locations, visible in x-ray images; and

means for determining the pose of the calibration grid relative to either the x-ray source or x-ray receiver;

wherein the calibration grid is held in one or more poses between the x-ray source and x-ray receiver.

29. The image guided surgery system of claim 28 wherein the means for determining the pose of the calibration grid relative to the imaging device comprises a localizing device.

30. The image guided surgery system of claim 28 further comprising a mounting means for holding the calibration grid in a fixed and known pose relative to the imaging device.

31. An image guided surgery system with the set of first imaging model parameters of claim 21 wherein appropriate second imaging model parameters for a given pose are calculated by interpolation of a subset of the set of first imaging model parameters.

32. The image guided surgery system of claim 21 wherein the pose of the imaging device is calculated relative to a horizontal plane.

33. The image guided surgery system of claim 32 wherein the localizing device comprises a sensor unit, and said sensor unit is attached to a cart by a rigid support structure of known geometry and dimensions, such that the sensor unit'"'"'s orientation relative to the horizontal plane is known.

34. The image guided surgery system of claim 32 wherein the localizing device comprises a sensor unit, and said sensor unit is attached to a cart by a rigid support structure of known geometry and dimensions and adjustable joints with rotary position encoders for measuring the angular position of each joint such that the sensor unit'"'"'s orientation relative to the horizontal plane is known.

35. The image guided surgery system of claim 32 wherein the localizing device comprises a sensor unit and the orientation of the sensor unit relative to the horizontal plane is determined by an inclinometer mounted on said localizer sensor unit.

36. The image guided surgery system of claim 32 wherein the orientation of the imaging device relative to the horizontal plane is calculated by inclinometers mounted on the imaging device.

37. The image guided surgery system of claim 21 wherein the imaging model parameters comprise mapping model parameters and the first means for determining said mapping model parameters comprises:

a calibration grid having markers, visible in x-ray images;

means for determining the positions of the markers in the x-ray images; and

means for determining the positions of the markers relative to the x-ray receiver;

wherein the calibration grid is held in proximity to the x-ray receiver.

38. A computer assisted surgery apparatus to enable a surgeon to align a first surgical tool with a second surgical tool, comprising:

a first surgical tool and a second surgical tool;

a localizing device for determining the pose of a first coordinate frame associated with the first surgical tool and the pose of the second surgical tool;

means for displaying representations of the two surgical tools relative to one another;

means for generating a computer model relating a graphic representation of the first surgical tool to the first coordinate frame associated with the first surgical tool;

means for determining the pose of a picture plane relative to the first surgical tool;

means for projecting the representation of the first surgical tool onto the picture plane for display on the display means; and

means for superimposing the representation of the second surgical tool over the projected representation of the second surgical tool.

39. The computer assisted surgery apparatus of claim 38 wherein the first surgical tool is attached in a fixed and known relationship to an implant or other object.

40. A computer assisted surgery apparatus to enable a surgeon to align a first surgical tool with a second surgical tool, comprising:

a first surgical tool and a second surgical tool;

a localizing device for determining the poses of the first and second surgical tools; and

means for displaying representations of the two surgical tools relative to one another;

wherein an axis of the first surgical tool is to be aligned along a line between a point on the first surgical tool and a reference point on the second surgical tool, and wherein a picture plane is defined that is perpendicular to said line and contains the reference point of the second surgical tool, and wherein alignment representations corresponding to the reference point on the second surgical tool and the intersection of said axis of the first surgical tool with the picture plane are displayed, such that the alignment representations are coincident when said axis of the first surgical tool passes through the reference point of the second surgical tool.

41. The computer assisted surgery apparatus of claim 40 further comprising means for displaying the distance from a point on the first surgical tool to the reference point of the second surgical tool.

42. An image guided surgery system to enable a surgeon to move one or more surgical tools into a desired pose relative to a body part, comprising:

an imaging device for generating a plurality of images of the body part;

a plurality of tracked objects and a first tracked object is a surgical tool;

a localizing device comprising one or more controllers and two or more sensor units, each with an associated coordinate frame and comprising a plurality of individual sensor elements and each sensor unit capable of providing sufficient data to permit the calculation of the poses of the tracked objects;

means for determining the poses of the tracked objects based on the data from one or more sensor units;

means for displaying representations of the surgical tool relative to images of the body part; and

means for determining the relationship among the coordinate frames of the sensor units.

43. The image guided surgery system of claim 42 wherein the pose of the surgical tool is read from a first sensor unit, and a second tracked object is the imaging device whose pose is read from a second sensor unit.

44. The image guided surgery system of claim 42 wherein the pose of the surgical tool or a second tracked object is determined from data from a first sensor unit, data from a second sensor unit, or simultaneous data from more than one sensor unit.

45. The image guided surgery system of claim 42 wherein the sensor elements are mounted on the ceiling of an operating room.

46. The image guided surgery system of claim 42 wherein the means for determining the relationship among the coordinate frames of two or more sensor units comprises:

a registration object having a plurality of localizing emitters in a fixed and known relationship and spaced such that one or more localizing emitters are visible to two or more sensor units substantially simultaneously; and

means to calculate the relationship between the two or more sensor units from the registration object pose or poses as calculated from data from each of the sensor units.

47. An image guided surgery system to enable a surgeon to verify the accuracy of superpositioning a representation of a surgical tool on an image comprising:

an imaging device for generating a plurality of images;

one or more surgical tools whose poses relative to the imaging device can be tracked by a localizing device;

means for recording the pose of a surgical tool substantially simultaneous to the acquisition of an image of the surgical tool; and

means for calculating and displaying a representations of the surgical tool at the recorded pose relative to the image of the surgical tool;

whereas the surgeon has sufficient time to determine the accuracy with which the surgical tool in the image is overlaid by the representation of the surgical tool at its recorded pose.

48. The image guided surgery system of claim 47 further comprising a timer of predetermined value for providing the surgeon with said sufficient time to determine the accuracy of the system.

49. The image guided surgery system of claim 47 further comprising means for allowing the surgeon to enable or disable the display of the representation of the surgical tool at its recorded pose.

50. An image guided surgery system to enable a surgeon to move one or more hand-held instruments into a desired pose relative to a body part, comprising:

a surgical tool whose pose can be tracked by a localizing device;

a display device having a screen defining a plane in a known pose relative to the localizing device;

means for calculating the pose of the surgical tool and for calculating the location where the trajectory of a specified axis of the surgical tool intersects the plane of the display device;

means for comparing the location of the intersection with locations of predefined fields in the plane of the display device; and

means for initiating an action associated with each field if an activation criterion is met;

wherein the surgeon may provide input to the system via selection of a predefined field and satisfaction of the activation criterion.

51. The image guided surgery system of claim 50 wherein the activation criterion comprises the activation of a button, trigger, switch, or voice activated switch.

52. The image guided surgery system of claim 50 wherein the activation criterion comprises the continued selection of a field for a specified period of time.

53. The image guided surgery system of claim 50 wherein the activation criterion comprises performance of a characteristic tool motion.

54. An image guided system to enable an operator to move one or more tools into a desired pose relative to a work piece, comprising:

an imaging device for generating a plurality of two-dimensional images of a work piece, said imaging device including an x-ray generator and a flat panel x-ray imager;

at least one tool;

a localizing device for measuring the three-dimensional pose of the tool; and

a means for displaying representations of the three-dimensional pose of the tool relative to the two-dimensional images of the work piece.