US20030187351A1

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Publication number: US20030187351A1
Application number: US10/402,499
Authority: US
Inventors: Joel Franck; Frederick Haer; Ronald Franklin
Original assignee: Neutar a Maine Corp LLC
Current assignee: Neutar a Maine Corp LLC
Priority date: 1998-04-21
Filing date: 2003-03-28
Publication date: 2003-10-02
Also published as: US6546277B1

Abstract

A method and apparatus for positioning a surgical instrument during stereotactic surgery on a body, for example, during spinal surgery or general surgery. A mounting device is attached to a bone structure of the body, for example, by attaching a rail to the spine for spinal surgery, or a mounting plate and a rod attached to the mounting plate. In spinal surgery, the rail is attached to the spine by clamping the rail to two spinous processes and adjusting the separation of the two spinous processes to match the separation of the two processes in three-dimensional scanned image, thereby matching a curvature of the spine with a corresponding curvature of the spine in the image. Multiple of fiducial points are located on the body in relation to the mounting device. An adjustable guidance fixture that includes an instrument guide for guiding the surgical instrument along a constrained trajectory relative to the instrument guide is attached to the mounting device. A location and orientation of the instrument guide is tracked and a position of the constrained trajectory in the three-dimensional image is computed. The guidance fixture is adjusted relative to the mounting device using a first constrained motion followed by a second constrained motion, so that the constrained trajectory of the instrument guide passes through the target.

Description

RELATED APPLICATIONS

This is a divisional application of U.S. application “INSTRUMENT GUIDANCE SYSTEM FOR SPINAL AND OTHER SURGERY,” Ser. No. 09/317,676, filed May 24, 1999, which is a continuation-in-part application of U.S. application “INSTRUMENT GUIDANCE FOR STEREOTACTIC SURGERY,” Ser. No. 09/063,658 filed Apr. 21, 1998 and a continuation-in-part of U.S. application “REMOVABLE FRAMES FOR STEREOTACTIC LOCALIZATION,” Ser. No. 09/063,930 filed Apr. 21, 1998, and also claims the benefit of U.S. Provisional application serial No. 60/096,384, filed Aug. 12, 1998.[0001]

BACKGROUND

This invention relates to instrument guidance for stereotactic surgery.[0002]

Stereotactic localization is a method for locating a target within a three-dimensional object. This method is used in the medical arts and sciences to locate a target in the human body, in particular in the brain or spine, for medical and surgical treatment. Stereotactic surgery has a history dating back to the turn of the century, when the Horsely-Clark Apparatus was described as a mechanical frame system in which an animal was immobilized. This frame system permitted reproducible targeting within the animal's brain for physiological experiments. This and similar technology found application in 1948 in the work of Wycis and Speigel. In their work, a frame was attached to a human skull. The frame permitted targeting of sites within the human brain for neurosurgical treatment. A detailed survey of the field of stereotactic surgery can be found in[0003]Textbook of Stereotactic and Functional Neurosurgery, P. L. Gildenberg and R. R. Tasker (eds.), McGraw-Hill, June 1997 (ISBN: 0070236046).

One approach to stereotactic surgery involves the following steps. Fiducial scanning markers are attached to the body in one of a variety of manners, including using an attachable frame or attaching the markers to the skin with an adhesive. A scan is then taken of a body, for example of the head, to produce a three-dimensional image of the body. Scanning can be done using a variety of techniques including CT, MRI, PET, and SPECT. Images of the fiducial scanning markers that are located around the body are then located in the three-dimensional image at fiducial image points. Points of interest, such as the location of a tumor, are located in the three-dimensional image with reference to these fiducial image points. The body and the image are registered by matching the locations of the scanning markers and the coordinates of the fiducial image points. In an approach to stereotactic brain surgery, a three-dimensional frame is screwed to the patient's skull prior to scanning the head. This frame serves as a mechanical reference mechanism that supports scanning fiducial markers at fiducial points around the body. The frame remains attached to the patient's skull from before scanning until after surgery is complete. Prior to surgery, a mechanical guide assembly is attached to the frame. The relative location in the image of the point of interest with respect to the fiducial image points is determined, and this relationship is used to adjust the mechanical guide assembly with respect to the fiducial points on the frame. Using the adjusted mechanical guide assembly, a surgical instrument is then guided to a location in the body that corresponds to the point of interest in the image.[0004]

In another form of stereotactic surgery, known generally as “image-guided” stereotactic surgery, rather than relying on mechanical adjustment of a guide assembly, visual feedback is provided to a surgeon by displaying a composite image formed from the scanned three-dimensional image and a synthesized image of a hand-held surgical instrument. The surgeon guides the hand-held instrument into the body using the visual feedback. In this form of surgery, a frame is attached to the patient and a scan is taken as described above. After scanning, the head and frame are secured in a fixed position, for example, fixed to an operating table. In order to display the image of the surgical instrument in a proper relationship to the scanned image, the position and orientation of the instrument is sensed using a localization apparatus that remains in a fixed position relative to the body. The localization apparatus can be coupled to the surgical instrument using an articulated mechanical arm on which the surgical instrument is attached. Sensors in the joints of the arm provide signals that are used to determine the location and orientation of the instrument relative to a fixed base of the mechanical arm. Some more recent systems do not use mechanical coupling between the surgical instrument and the localization apparatus and instead rely on remote sensing of small localized energy emitters (e.g., sources or transducers of energy) fixed to the instrument. For example, a camera array is used to locate light-emitting diodes (LEDs) that are attached to the instrument. The locations of the LED images in the camera images are used to determine the three-dimensional physical locations of the LEDs relative to the camera array. The locations of multiple LEDs attached to the instrument are then used to determine the location and orientation of the instrument. Another example of remote sensing uses sound generators and a microphone array and relies on the relative time of arrival of acoustical signals to determine the three-dimensional locations of the sound generators.[0005]

Before a synthesized image of the instrument can be combined with the scanned image in a proper relationship, some form of registration is required. For example, the tip of the surgical instrument can be placed at each of several fiducial markers for which corresponding images have been located in the three-dimensional scanned image. Registration of the synthesized image of the instrument and the scanned image can thereby be established.[0006]

In a variant of image-guided stereotactic surgery, generally known as “dynamic referencing,” the head and frame are secured in a fixed position, as in the image-guided approach. However, unlike other image-guided techniques, the sensors (e.g., cameras) of the localization apparatus are not at a fixed location. In order to compensate for the motion of the sensors, energy emitters are fixed to the frame as well as to the instrument. At any point in time, the location and orientation of the frame relative to the sensors as well as the location and orientation of the instrument relative to the sensors are both determined, and the differences in their locations and orientations are used to compute the location and orientation of the instrument relative to the frame. This computed location of the instrument is then used to display the synthesized image of the surgical instrument in an appropriate relationship to the scanned image.[0007]

Still another approach to stereotactic surgery, generally known as “frameless image-guided” stereotactic surgery, does not rely on attaching a frame to the body before scanning. Instead, adhesive fiducial scanning markers are applied to the scalp, or small screws are inserted into the skull, and the patient is scanned as in the techniques described above. During surgery, the patient is immobilized and locked in place using a head clamp or a frame. The image-guided stereotactic approach described above is then followed, including the registration procedure described above to establish the locations of the fiducial scanning markers relative to the instrument.[0008]

In image-guided techniques, a surgeon can rely on a variety of views of a three dimensional scanned image. These views can include a three-dimensional surface view with an adjustable point of view (e.g., a perspective view with surface shading). In addition, planar (i.e., two-dimensional) views of the image can be displayed. In particular, three two-dimension “slices” through orthogonal planes of the image are typically displayed, with the orientations of the planes being sagittal (dividing a head into a left and a right part), coronal (dividing a head into a front and a back part), and axial (dividing a head into an upper and lower part). As the orientations of the planes are predetermined, the particular planes that are displayed can be determined by the point of intersection of the three planes. A point, such as the tip of a probe, can be displayed in a three-dimensional surface view as a point in a appropriate geometric relationship. The point can be displayed in a planer view by orthogonally projecting the point onto the associated plane. A line can be displayed in a planar view as an orthogonal projection onto the associated plane, or as the point of intersection of the line and the associated plane. Note that if a first point, such as a surgical entry point is used to determine which planes are displayed, a second point, such as a surgical target point, does not in general fall in any of the displayed planes.[0009]

Planar views of a three-dimensional scan can also use alternative orientations than the standard sagittal, coronal, and axial orientations described above, allowing two points to lie in two orthogonal planes, and one of the two points to additionally lie in a third orthogonal plane. In particular, a “navigational” view can be determined according to two points in an image, such as an entry point at the surface of a body and a target point within the body. The line joining the entry point and the target point is chosen as the intersection of two orthogonal planes,[0010]

navigation planes

1 and2. The orientation of

navigational planes

1 and2 is arbitrary (that is, the two planes can be rotated together around their intersecting line). A third plane, orthogonal to

navigation planes

1 and2, provides a “bird's eye” view looking from the entry point to the target point. This bird's eye plane is typically chosen to pass through the target point. (Such a navigational view is shown in FIG. 14a). Using a navigational view, the orientation of a surgical instrument is typically shown as a line projected orthogonally onto the two navigational planes, and as the point of intersection of the line and the bird's eye plane. Manipulating an instrument using such a navigational view for feedback requires considerable practice and is not intuitive for many people.

Image-guided frameless stereotaxy has also been applied to spine surgery. A reference frame is attached to an exposed spinous process during open spine surgery, and a probe is used to register the patient's spine with scanned image of the spine. Anatomical landmarks are used as fiducial points which are located in the scanned image. Visual feedback is provided to manually guide placement of instruments, such as insertion of pedicle screws into the spinal structures.[0011]

SUMMARY

In one aspect, in general, the invention is a method for positioning a surgical instrument during stereotactic surgery on a body, for example, during spinal surgery or general surgery. In this method, the body has been previously scanned to produce a three-dimensional image of the body which includes a target. A mounting device is attached to a bone structure of the body, for example, by attaching a rail to the spine, or a mounting plate to the pelvis and attaching a rod to the mounting plate. Multiple of fiducial points are located on the body in relation to the mounting device. For example, the fiducial points are anatomical points which are located using a remote sensing device that is used to track the mounting device and a probe that is placed at the fiducial points. The method also includes providing an adjustable guidance fixture that includes an instrument guide for guiding the surgical instrument along a constrained trajectory relative to the instrument guide. A location and orientation of the instrument guide is tracked and a position of the constrained trajectory in the three-dimensional image is computed. The guidance fixture is adjusted relative to the mounting device using a first constrained motion followed by a second constrained motion, so that the constrained trajectory of the instrument guide passes through the target. The method further includes driving the surgical instrument along the constrained trajectory toward the target, and subsequently removing the mounting device from the bone structure.[0012]

The method can include one or more of the following features.[0013]

The rail is attached to the spine by clamping the rail to two spinous processes and adjusting the separation of the two spinous processes to match the separation of the two processes in three-dimensional scanned image, thereby matching a curvature of the spine with a corresponding curvature of the spine in the image.[0014]

Locating the fiducial points in relation to the rail includes tracking a location and orientation of the rail using a remote sensing device and also tracking a location of a point on a probe using the remote sensing device. The point on the probe is positioned at the fiducial points. When the fiducial points are anatomical points of one vertebral segment, this facilitates poly-segmental tracking via unisegmental mapping registration[0015]

The tracked location and orientation of the rail is compared to the tracked location of the point on the probe to determine the location of the fiducial points in relation to the rail.[0016]

In another aspect, in general, the invention is a method for positioning a surgical instrument during stereotactic spinal surgery, the spine having been previously scanned to produce a three-dimensional image of the spine which includes a target on the spine. A longitudinal rail is attached to the spine. Attaching the rail to the spine can include clamping the longitudinal rail to two spinous processes and adjusting the separation of the two spinous processes to match a separation of the two processes in the three-dimensional image, thereby maintaining a fixed geometric relationship between the longitudal rail and a portion of the spine between the two spinous processes and matching a curvature of that portion spine with a corresponding curvature of that portion of the spine in the three-dimensional image. Multiple anatomical fiducial points are located on the spine in relation to the longitudinal rail. Locating these points includes tracking a location of the longitudinal rail with using a remote sensing device, tracking a location of a probe positioned at each of the fiducial points using the remote sensing device, and comparing the location of the probe and the location of the longitudinal rail at each of the fiducial points. An adjustable guidance fixture that includes an instrument guide for guiding the surgical instrument along a constrained trajectory relative to the instrument guide is attached to the rail. A location and orientation of the instrument guide is tracked and a position of the constrained trajectory in the three-dimensional image is computed. A planar section of the three-dimensional image of the body in conjunction with a representation of the constrained trajectory, the planar section containing the target on the spine. The guidance fixture is adjusted using a first constrained motion until the constrained trajectory of the instrument guide lies in a plane corresponding to the displayed planar section and using a second constrained motion, such that the orientation continues to lie in the plane corresponding to the displayed planar section, until the constrained trajectory passes through the target point. The surgical instrument is driven along the constrained trajectory toward the target, including tracking a location of the surgical instrument and displaying the location of the surgical instrument in conjunction with the scanned image.[0017]

In another aspect, in general, the invention is an apparatus for stereotactic surgery on a spine. The apparatus includes a guidance fixture that includes an instrument guide for moving a surgical instrument along a constrained trajectory. The apparatus also includes a mounting device that includes a longitudinal rail and multiple clamps for securing the longitudinal rail to the spine, and an adjustment mechanism for adjusting the location and orientation of the constrained trajectory relative to the mounting device. The apparatus also includes a signaling device for providing signals related to a location and orientation of the constrained trajectory.[0018]

In another aspect, in general, the invention is an apparatus for stereotactic surgery on a body. The apparatus includes a guidance fixture that includes (a) an instrument guide for moving a surgical instrument along a constrained trajectory relative to the instrument guide, (b) an adjustable portion supporting the instrument guide, including a base having a central axis and an adjustment mechanism coupled between the base and the instrument guide, wherein a configuration of the adjustment mechanism determines an orientation of the instrument guide relative to the central axis of the base, and (c) a signaling device for providing a signal representation of the configuration of the adjustment mechanism. The apparatus also includes a mounting device coupled to the guidance fixture for attaching the guidance fixture to the body, the mounting device including an attachment portion for rigid attachment to a bone structure of the body.[0019]

The invention can include one or more of the following features.[0020]

The attachment portion of the mounting device includes a first clamp for attaching the mounting device to a first point on a spine, and the mounting device further includes a longitudinal rail.[0021]

The attachment portion includes a second clamp for attaching the mounting device to a second point on the spine.[0022]

The mounting device further includes a transverse rail coupled between the longitudinal rail and the guidance fixture and an adjustable coupler coupling the longitudinal rail and the transverse rail.[0023]

The mounting device further includes a tracking device which when the mounting device attached to the body is rigidly coupled to the body, the tracking device provides a signal representation of a position of the body.[0024]

The tracking device includes multiple tracking markers, for example energy reflectors or emitters, and the signal representation of the position of the body includes multiple signals, such as electromagnetic, optical, or acoustic signals, propagating from corresponding tracking markers.[0025]

The mounting device further includes an adjustable portion coupling the attachment portion to the guidance fixture.[0026]

The attachment portion includes a mounting plate for attaching the mounting device directly to a bone structure of the body.[0027]

The mounting device further includes a rod removably attached to the mounting base.[0028]

An advantage of the invention is that it permits accurate stereotactic surgery on various parts of the body, and in particular, allows accurate stereotactic surgery on the spine. Attaching the guidance fixture to a mounting device that is attached to a bone structure, such as a rail attached to a spine, provides a way of holding the guidance fixture in a fixed relationship to a target in the body.[0029]

An advantage of using a spinal rail is that by using two clamps, the spine can be maintained in a fixed curvature and the curvature can be adjusted to match the curvature at the time that a scan was taken. In this way, a single spinal segment can be registered with scanned image and thereby achieve registration for a series of spinal segments. This reduces the amount of time taken in surgery that would be needed to repeatedly re-register each spinal segment.[0030]

Other features and advantages are apparent from the following description and from the claims.[0031]

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a flowchart of a stereotactic brain surgery procedure;[0032]

FIG. 2 is a head with threaded inserts implanted including a cross-sectionial view of the skull and a threaded insert;[0033]

FIG. 3 is a head with a scanning MIRRF attached including a detailed exploded view of the attachment of the MIRRF to the implanted threaded inserts;[0034]

FIG. 4 illustrates scanning of a head on which a scanning MIRRF is attached;[0035]

FIG. 5 is a head with a tracking MIRRF attached and a cranial probe being tracked using a camera array;[0036]

FIG. 6 is a dataflow diagram for computation of a composite image including a synthesized image of a probe;[0037]

FIG. 7 illustrates locating a planned entry point using the tracked cranial probe and a computer display;[0038]

FIG. 8 is a display of a virtual burr hole and accessible cone of orientations;[0039]

FIG. 9 is a head with a tracking MIRRF and a guidance fixture attached being tracked using a camera array;[0040]

FIG. 10 is a view of a base platter and an adjustable base of a guidance fixture;[0041]

FIG. 11 is an exploded view of the adjustable base of a guidance fixture;[0042]

FIG. 12 is a dataflow diagram for computation of a composite image including a synthesized image of a surgical instrument;[0043]

FIG. 13 is a detailed flowchart of trajectory replanning and fixture alignment;[0044]

FIGS. 14[0045]a-cillustrate a navigational view display and corresponding planar segments through a body;

FIGS. 15[0046]a-fillustrate a “field of view” display and corresponding conical section through a body;

FIG. 16 is a guidance fixture including an adjustable base and an instrument drive attached to a base platter;[0047]

FIGS. 17[0048]a-bshow a burr hole ring used to secure an instrument using a flexible membrane;

FIG. 17[0049]cis a retractor in a guidance fixture;

FIG. 18 is a calibration jig;[0050]

FIG. 19 is a phantom jig and a guidance fixture and a tracking MIRRF attached to the jig;[0051]

FIG. 20 is an arc shaped MIRRF attached to a head including a view of a threaded insert and mounting bolt;[0052]

FIG. 20[0053]ais a MIRRF attached to a subcutaneous insert;

FIG. 21 is a scanning marker and a tracking marker attached to a threaded insert;[0054]

FIG. 22 is a guidance fixture and a tracking MIRRF attached to a conventional stereotactic frame;[0055]

FIG. 23 is a tracking MIRRF attached directly to a guidance fixture;[0056]

FIGS. 24[0057]a-billustrate an instrumented guidance fixtures;

FIGS. 25[0058]a-billustrate an actuated guidance fixture;

FIG. 26 illustrates a remotely controlled guidance fixture;[0059]

FIG. 27 illustrates a teleoperator configuration;[0060]

FIG. 28 illustrates locating a mounting base using a mechanical arm;[0061]

FIGS. 29[0062]a-dillustrate a head-mounted mechanical arm;

FIG. 30 is a flowchart of a spinal surgery procedure;[0063]

FIGS. 31[0064]a-billustrate a guidance fixture attached to spinal rails for spinal surgery;

FIGS. 32[0065]a-billustrate a guidance fixture attached to the pelvis for general surgery; and

FIG. 33 is a head-mounted camera array.[0066]

DESCRIPTION

Brain Surgery[0067]

Referring to FIG. 1, an aspect of the invention relates to stereotactic brain surgery. This approach to brain surgery involves a series of steps, shown in FIG. 1, from[0068]

start

100 prior to scanning throughfinish199 after the surgical phase of a procedure is completed. There are generally two phases to the approach. The first phase involves creating a three-dimensional image of the head (

steps

105,110,115,120), planning a surgical trajectory based on the image (step125), and validating the guidance fixture (step130) that will be used during the surgical procedure. The second phase involves the remaining steps (steps135 through195) that are used to carry out the actual surgical procedure. The steps of the first phase can be carried out quite some time before those of the second phase. For example, creating the three-dimensional image of the head can be done on one day, and the steps used to carry out the actual surgery can be done on a subsequent day. Also, the steps of the second phase may be repeated, for example on several different days, illustrated bytransition192 between

steps

195 and135.

Pre-Operative Phase[0069]

One to three days prior to surgery, the patient is seen in a post anesthesia care unit (PACU) or other suitable location. Referring to FIG. 1, the first step of the procedure is to attach anchors to which scanning, registration, and tracking markers will be subsequently attached (step[0070]105). Referring to FIG. 2, the anchors include two threadedinserts220 that are surgically implanted into the patient'sskull210 using a template (described below). The template precisely determines the separation and parallel orientation ofinserts220.

Referring to FIG. 3, a rigid cross-shaped device, a scanning “miniature removable reference frame” (scanning MIRRF)[0071]310, is next attached to threadedinserts220 using screws320 (FIG. 1, step110). Aretention plate330 is used to aid precise reattachment of scanningMIRRF310 to the skull.Retention plate330 is also used as the template during insertion of threaded inserts220. ScanningMIRRF310 includes fourfiducial scanning markers340 that will be visible in the scanned image. ScanningMIRRF310 is made from a material that is chosen to interfere as little as possible with the type of scan that will be performed. For example, for MRI and CT scans, the chosen material can be polycarbonate, which results in scanningMIRRF310 being almost invisible in the scanned image.Fiducial scanning markers340 are mounted in spherical cavities in scanningMIRRF310. The design of the cavities is such that the “press-in” marker inserts can be removed for cleaning. The star-shaped design ofscanning MIRRF310 is such that, when attached, the elongated part of the star extends behind or in front of the ear so that mountingscrews320 are located toward the top of the skull where soft tissue thickness is minimal and skull thickness is maximal. This minimal tissue thickness allows threadedinserts220 to be implanted easily under local anesthetic by making a small incision. As an alternative to attaching a single MIRRF as shown in FIG. 3, multiple MIRRFs can be attached in a similar manner to increase the number or separation of the scanning markers.

Referring to FIG. 4, MRI or[0072]

CT scanner

400 is used to obtain a three-dimensionaldigitized image410 of the head, for example, as a series of two-dimensional “slices” (step115 in FIG. 1). In addition, a model or map of the surface of the skull can be made allowing, for instance, subsequent three-dimensional surface display of the skull. Thefiducial scanning markers340 producefiducial images420 at inimage410. Fiducial coordinates421 offiducial images420 in the coordinate system ofimage410 are determined, for example, by manually positioning a cursor atfiducial images420 on a computer display.Image410, along with thefiducial coordinates421, are stored on a computerreadable storage medium430 for use during the subsequent surgical phase of the approach. Typically the image is stored as a series of two-dimensional images, each corresponding to a horizontal “slice” of the head.

After scanning, scanning[0073]

MIRRF

310 is removed (FIG. 1, step120), and threadedinserts220 are left in place. Antibiotic ointment can be applied and the patient is either discharged or sent to the operating room.

Also after scanning, a surgeon determines the location of a target point within the brain and an entry point through the skull (FIG. 1, step[0074]125). A planned surgical trajectory is then determined as the line joining the entry point and the target point. The surgeon plans the trajectory using a computer display ofimage410 which provides, for example, a three-dimensional surface view, and sagittal, coronal, and axial planar views. This allows the surgeon, for example, to plan a trajectory that avoids critical structures in the brain. The target and entry points, and the trajectory are stored along with the image onstorage medium430.

Other than an optional fixture validation (FIG. 1, step[0075]130), all the preoperative steps are complete at this point.

Surgical Phase[0076]

Referring to FIG. 5, the surgical phase of the procedure begins by attaching a tracking[0077]

MIRRF

510 to threaded inserts220 (not shown) that remained implanted in the patient's skull after scanningMIRRF310 was previously removed.Tracking MIRRF510 has a very similar structure to scanningMIRRF310.Tracking MIRRF510 includesfiducial divots540 at the centers of locations corresponding to fiducial markers340 (shown in FIGS. 3 and 4). Four trackingLEDs550 are also attached to trackingMIRRF510. Since trackingMIRRF510 is rigid, the geometric relationship between trackingLEDs550 andfiducial divots540 is fixed and can be determined beforehand and verified in a subsequent verification step, or can be unknown and determined in a subsequent registration step. Preferably, trackingMIRRF510 is made of a material that is lightweight and can be autoclaved, such as Radel.

After attaching tracking[0078]

MIRRF

510 to the patient's skull, the patient can be comfortably placed in an awake, possibly lightly sedated, state in an operating room chair, which is similar to a dental chair. The patient is allowed to recline in an essentially unrestrained manner in the operating room chair in a semi-sitting position. Alternatively, at the surgeon's prerogative and if appropriate, general anesthesia can be administered to the patient.

Referring still to FIG. 5, a[0079]

camera array

560 provides time-varyingdigitized images586 to alocalization application588 executing on acomputer workstation580. The patient can be free to move relative tocamera array560 and relative to the operating room chair, andcamera array560 can be free to move relative to the patient and relative to the operating room chair.Camera array560 includes threeCCD cameras562 positioned in a fixed configuration relative to one another. Alternatively, two cameras, which are sufficient for three dimensional localization, or more than three cameras, which may provide greater accuracy, can be used. Eachcamera562 incamera array560 produces one time-varying image. Each trackingLED550 on trackingMIRRF510 is powered and emits infra-red illumination which is seen as a bright point in each of time-varyingdigitized images586. Based on the relative coordinates of the bright points inimages586 from eachcamera562 ofcamera array560

localization application

588 computes the position (i.e., the coordinates) of trackingLEDs550 in the coordinate system ofcamera array560. Using the positions ofmultiple tracking LEDs550, the location and orientation of trackingMIRRF510 can be computed bylocalization application588. Tracking of MIRRF coordinates510 is illustrated schematically byline564.

A[0080]

cranial probe

570, including threeprobe LEDs572 attached along its length, is also tracked usingcamera array560 andlocalization application588. Based on the coordinates of the images ofprobe LEDs572 inimages586 andprobe geometry584,localization application588 computes the position and orientation ofprobe570 in the coordinate system ofcamera array560.

Registration[0081]

Using[0082]

cranial probe

570, the surgeon then carries out a registration step (FIG. 1, step140). In this registration step, the surgeon first locates the fiducial points in the image. Then he touches the tip ofprobe570 to each offiducial divots540 in trackingMIRRF510 in turn, indicating tolocalization application588 when he is touching each of the divots.Localization application588 then computes a three-dimensional conformal registration (map) betweenimage410 and the coordinate system of trackingMIRRF510.

Note that if the geometric relationship of tracking[0083]

LEDs

550 andfiducial divots540 is known tolocalization application588, for example using a previously calibrated MIRRF, the coordinates of the fiducial divots can be computed from the coordinates of the tracking LEDs, which in turn can be computed from the locations of the fiducial images in the camera images. The step of touching the divots can be omitted in this case, or used to verify the computed coordinates of fiducial divots.

Having computed the conformal mapping,[0084]

localization application

588 continuously combinesimage410 and a synthesized image ofprobe570 to form acomposite image599 that combines the scanned image with the synthesized image of the probe.Composite image599 is shown on acomputer display610 which includes a three-dimensional surface display.

Referring to FIG. 6, the registration and image composition functions performed by[0085]

localization application

588 involves a series of data processing stages. As shown in FIG. 5, time-varyingdigitized images586 are provided tolocalization application588 fromcamera array560. Referring to FIG. 6, time-varyingdigitized images586 are input to MIRRF tracking591, a processing stage oflocalization application588, which tracks trackingLEDs550 on trackingMIRRF510 and produces “MIRRF/cam”593, an orientation and location of trackingMIRRF510 in the coordinate system ofcamera array560. At the same time, probe tracking590

tracks probe

Referring still to FIG. 6, the next stage of[0086]

localization application

588,probe mapping596, takes the continually updated probe coordinates, probe/MIRRF595, andconformal map589, and computes probe/image597, the coordinates ofprobe570 in the coordinate system ofimage410. Then,image composition598 combinesimage410 and a synthesized image ofprobe570 to formcomposite image599.

[0087]

Composite image

599 typically includes a three-dimensional surface view and three orthogonal planar views. The orthogonal planar views can correspond to the three standard orientations, sagittal, coronal, and axial planes, for instance passing through the planned target point. More typically, three planar views of a navigational view that is determined by the planned entry and target points are included incomposite image599. The tip of the probe is displayed as an orthogonal projection onto the planes of the planar views, and as a point in an appropriate geometric relationship in the three-dimensional surface view. The orientation of the probe can be displayed using a line passing through the tip of the probe and displayed as a orthogonal projection onto

navigational planes

1 and2 of the navigational view, and as a point of intersection on the bird's eye view of the navigational view.

If the geometric relationships of the fiducial points, fids/[0088]

MIRRF

582, the coordinates offiducial divots540 does not match the geometric relationships offiducial coordinates421, then an error in placingprobe570 during the registration procedure may have occurred. If such an error is detected,conformal mapping589 is not computed, a warning is provided to the surgeon, and the surgeon must perform the registration procedure again. Furthermore, if the geometric relationships betweenfiducial divots540 is known through prior measurement or calibration, registration errors and errors locatingfiducial points420 inimage410 can also be detected.

Referring to FIG. 7, a[0089]

cranial probe

570 is used to determine an actual entry point. Acomputer display610 showscomposite image599, which includes a three-dimensional surface view and three planar views of a navigational view determined by the planned entry and target points.

Referring to FIG. 8, a[0090]

virtual burr hole

640 is displayed in the planar views of navigational view at theprobe location642 ofcranial probe570. In addition, the range of adjustable orientations of a guidance fixture that would be attached atprobe location642 is displayed as acone644, and the extent of effects of x-y adjustment of the guidance fixture is displayed as asecond cone646. Display of

cones

644 and646 allows the surgeon to verify that plannedtarget point650 is accessible in the range of adjustments of a guidance fixture attached atprobe location642.

When the surgeon has located an[0091]

entry point

620 on the skull, he marks the entry point as the desired center point of attachment of a guidance fixture that will be used during the surgical phase of the procedure.

The patient then has a small area of the head shaved and draped off. A 2 to 4 cm linear incision is made over[0092]

entry point

620 after local anesthesia is administered. The location ofentry point620 is then reconfirmed usingcranial probe570 after the incision is made. An approximately 1 cm burr hole (not shown in FIG. 7) is then drilled through the skull at entry point620 (FIG. 1, step150). The surgeon opens the dura under the burr hole and visually inspects the area to determine that no critical structures, such as a blood vessel, are located directly under the burr hole. If the location of the burr hole is found to be unacceptable, a new entry point can be planned and return to the step of locating the entry point (FIG. 1, step145).

Attaching the Guidance Fixture[0093]

Referring to FIG. 9, having drilled the burr hole, the surgeon next attaches a[0094]

guidance fixture

710 to the skull (FIG. 1, step155). (Note that an optional instrument drive can also included in the guidance fixture but is not shown in FIG. 9.) As is described more fully below,guidance fixture710 includes abase platter720 on whichplatter LEDs730 are attached.Base platter720 is attached to anadjustable base715, which is in turn attached to the skull. The orientation of a line normal tobase platter720 is adjustable within a cone forming a solid angle of approximately 45 degrees. After attachingguidance fixture710 the surgeon adjusts the orientation of base platter720 (FIG. 1,step170; note that

optional steps

160 and165 are described below). Asurgical instrument740, including aninstrument LED742 fixed relative to the instrument, passes throughguidance fixture710.Surgical instrument740 is constrained to follow a fixed trajectory perpendicular to and through a central opening through adjustedbase platter720.Workstation580 tracks the location and orientation ofbase platter720, and the displacement ofsurgical instrument740, indicated schematically by

lines

564 and750 respectively, and computes the position ofsurgical instrument740 in the coordinate system ofimage410.Workstation580 continually displays on display610 acomposite image750 including a navigational view ofimage410 showing the position and orientation ofsurgical instrument740. The surgeon uses the visual feedback ondisplay610 to positionsurgical instrument740 along the constrained trajectory. Note that during this time, the patient is not necessarily immobilized. Both the patient andcamera array560 can move and, as long asplatter LEDs730 andinstrument LED742 are visible tocamera array560 at an appropriate distance and orientation,workstation580 call maintain a continuously updated display.

Referring to FIG. 10,[0095]

guidance fixture

710 includesbase platter720 andadjustable base715. In use,base platter720 is attached to an entry column850 (through an x-y positioning table1150, described fully below) which is held inadjustable base715. The orientation ofentry column850 can be adjusted relative toskull210 using separate rotation and pivoting motions, as described below. Referring also to the exploded view ofadjustable base715 shown in FIG. 11,guidance base715 includes a mountingbase820, which is rigidly attached to the skull during an operation using screws through mountingholes822. Mountingholes822 pass through mountingtabs723 as well as through the inside of the mountingbase820. Mounting tabs823 are pliable to allow them to conform to the skull. As mountingbase820 may be distorted in being mounted to the skull, it can be designed to be disposable. Mountingbase820 has a cylindrical opening which accepts arotating collar830. Arotation locking screw824 in mountingbase820, when tightened,locks rotating collar830 in place and prevents its movement within the mounting base.Entry column850 is held withinrotating collar830 by apivoting collar840. Pivotingcollar840 slides in an arc-shapedpivoting guide841 withinrotating collar830. When rotated, apivoting locking knob846 prevents pivoting/collar840 from sliding by drawing acollar clamp842 against pivotingcollar840 using a threadedrod920. When rotated, a pivotingadjustment knob844

slides pivoting collar

840 along pivotingguide841.

Referring again to FIG. 11, mounting[0096]

base

820 includes mountingholes822 drilled through mounting tabs723 (one tab is not visible on the side opposite the visible one), as well as through the inside of mountingbase820. Mountingbase820 includes a threadedhole922 within whichrotation locking screw824 turns.Rotation locking screw824 mates with a recessedchannel923 inrotating collar830, thereby preventing rotation ofrotating collar830 and also preventingrotating collar830 from lifting off mountingbase820.

[0097]

Entry column

850 includes acylindrical portion913 and aspherical portion914 at one end.Spherical portion914 mates with aspherical socket916 in the bottom ofrotating collar830. When mated,entry column850 can pivot withinrotating collar830.Entry column850 also has opposinggroves910 which mate withprotrusions912 on the inside of the circular opening in pivotingcollar840.Entry column850 passes through the circular opening, andprotrusions912 mate withgroves910. When assembled, the mated groves and protrusions hold thespherical portion914 ofentry column850 againstspherical socket916 in the bottom ofrotating collar830.

The position of pivoting[0098]

collar

840 within pivotingguide841 is adjusted by turning pivotingadjustment knob844 and tightened in place by rotatingpivoting tightening knob846. Pivotingadjustment knob844 attaches to a pivotingadjustment rod930 which passes throughcollar clamp842 and the main portion of pivotingcollar840 to a rack and pinion mechanism. Apinion931 is attached to the end pivotingadjustment rod930.Pinion931 mates with an arc-shapedrack932 which attaches torotating collar830 using threescrews934. Rotation of pivotingadjustment knob844 rotates pivotingadjustment rod930 andpinion931, which then slides pivotingcollar840 in pivotingguide841. Rotating pivotinglocking knob846

locks pivoting collar

840 rigidly torotating collar830. Tightening bothrotation locking screw824 and pivotinglocking knob846 fixes the orientation ofentry column850 relative to mountingbase820.

Referring to FIG. 10, the procedure for attaching and adjusting guidance fixture[0099]710 (FIG. 1,steps155 through170) is carried out as follows. Mountingbase820 is attached in a temporary fashion overburr hole625. While attaching the base, mountingtabs723 are conformed to the shape of theskull210 and secured to the skull an orientation generally directed towards the target using three or more titanium bone screws724 passing through mountingholes822 through mountingtabs723 and through the interior of the mounting base.

After mounting[0100]

base

820 is attached toskull210, the remainder ofguidance base715 is attached to mountingbase820. In particular, rotatingcollar830, withentry column850 already attached, and adjusted to be centered (oriented along the central axis of guidance base715) is inserted in mountingbase820 androtation locking screw824 is tightened to mate with recessedchannel923.

After[0101]

guidance base

715 is attached toskull210, the remainder ofguidance fixture710 is attached toguidance base715. In FIG. 10, the drive assembly, which is already attached tobase platter720 at thetime base platter720 is attached toguidance base715 is not shown.Base platter720 is attached toentry column850 via an x-y positioning table1150 (described below). During the alignment phase in which the orientation ofguidance base715 is adjusted, x-y positioning table1150 remains centered.

During a surgical procedure,[0102]

surgical instrument

740 is passed through acentral opening721 ofbase platter720 and throughentry column850 into the brain. During the alignment phase in which x-y table1150 is centered, a line along the trajectorysurgical instrument740 would follow passes along the central axis ofentry column850. Adjusting the orientation ofguidance base715 adjusts this trajectory. In all orientations, the trajectory passes through a single point on the central axis ofguidance base715 near the surface of the skull. If the guidance base is exactly mounted over the planned entry point, this single point is the planned entry point. More typically, the point is slightly displaced from the planned entry point due to mounting inaccuracies.

Referring again to FIG. 9,[0103]

platter LEDs

730 onbase platter720 are sensed bycamera array560, and the location and orientation ofbase platter720 in the coordinate system ofimage410 is computed bylocalization application588 executing oncomputer workstation580.Localization application588 computes the location and orientation ofbase platter720 using the known geometry of the base platter relative toplatter LEDs730.

Referring to FIG. 12,[0104]

localization application

588 computes composite image750 (FIG. 9) in a series of data transformations. Time-varyingdigitized images586 are passed to MIRRF tracking591 as well as platter tracking7010 and instrument tracking7012. MIRRF tracking591 produces “MIRRF/cam”592, the position and orientation of trackingMIRRF510 in the coordinate system ofcamera array560.Platter tracking7010 produces “platter/cam”7020, the position and orientation ofbase platter720. The instrument trajectory is at a known location and orientation relative toplatter LEDs730 onbase platter720, therefore the location and orientation of the instrument trajectory in the coordinate system ofcamera array560 is also known.Instrument tracking7012 produces instrument/cam7022, the location ofinstrument LED742 in the coordinate system ofcamera array560.Platter localization7030 usesconformal map589, MIRRF/cam593, and platter/cam7020 to compute platter/image7040, the location and orientation ofbase platter720 in the coordinate system ofimage410. Note that onceguidance fixture710 is attached and aligned, thenbase platter720 no longer moves relative to the skull (other than due to adjustment of x-y table1150) and therefore, platter/image7040 can be fixed rather than continuously recomputed.Instrument depth measurement7032 combines platter/cam7020 and instrument/cam7022 to compute instrument/platter7042, the depth of penetration of the surgical instrument relative to the plane ofbase platter720.Instrument depth measurement7032 makes use of the known displacement of the tip of the instrument frominstrument LED742.Instrument localization7050 takes platter/image7040 and instrument/platter7042 and computes instrument/image7060, the location and orientation of the surgical instrument in the coordinate system ofimage410. Finally,image composition7070 combinesimage410 with a synthesized image of the surgical instrument to generate acomposite image750.

Referring to FIG. 13, before aligning[0105]

guidance fixture

710, the surgical trajectory is optionally replanned to go through the center of the actual mounted position of the guidance fixture, rather than the planned entry point (FIG. 1, step165).

Aligning the Guidance Fixture[0106]

The surgeon aligns[0107]

guidance fixture

710 using visual feedback. Referring to FIGS. 14a-c, a navigational view indicating the trajectory of the surgical instrument is used. Referring to FIG. 14a,

navigational planes

1020 and1022 correspond to navigational

planar views

1030 and1032 respectively.

Navigational planes

1020 and1022 are orthogonal and their intersection forms a line passing through anentry point1010 and atarget point1012. Bird'seye plane1024, the third plane of the navigation view, is orthogonal to

planes

1020 and1024 and passes throughtarget point1012.

Referring to FIG. 14[0108]b-c,

navigational planes

1020 and1024 are shown schematically, along with aline1040 corresponding to the orientation ofguidance fixture710. The goal of the alignment procedure is to makeline1040 coincident with the intersection of

planes

1020 and1022. The alignment procedure is carried out in a series of two motions each of which is constrained to one degree of freedom. Initially,line1040 is not generally coincident with either navigational plane. Prior to beginning the alignment procedure, the orientation ofline1040 is displayed as orthogonal projections,

lines

1041 and1042, on

planes

1020 and1022, respectively.

In the first alignment motion, rotating[0109]

collar

830 is rotated within mounting base820 (FIGS. 10 and 11). Referring to FIG. 14b, this rotation causesline1040 to sweep out a portion of a cone, indicated diagrammatically by dashedarrow1050. After rotation through an angle φ₁,orientation line1040 is in the direction ofline1043, which is coincident withplane1022. During the rotation, theorthogonal projection line1041 ofline1040 inplane1020 forms a smaller and smaller angle θ₁with the desired orientation inplane1020, while the angle θ₂between theorthogonal projection line1042 inplane1022 and the desired orientation inplane1022 increases, ultimately to φ₂whenline1040 is coincident withplane1022.

Referring to FIG. 14[0110]c, the second alignment motion reduces the angle φ₂while maintaining the coincidence of the orientation line andplane1022. This motion corresponds to slidingpivoting collar840 within rotating collar830 (FIGS. 8 and 9). Alignment is achieved when angle φ₂is zero, that is, theorientation line1040 is coincident with the intersection of

planes

1020 and1022.

At this point, after tightening the locking knobs on[0111]

guidance fixture

710,base platter720 is firmly fixed to the skull, in an orientation and location that constrains a surgical instrument passing through it to pass along the replanned trajectory to the planned target point in the head.

In addition to, or as an alternative to, using a navigational view to provide visual feedback during the alignment procedure, a “field of view” display can be provided. Referring to FIGS. 15[0112]a-f, the field of view display uses a representation of a cross-section of a cone extending below the entry point. Referring to FIG. 15a, the central axis of acone1061 is coincident with the central axis of the mounting base of a guidance fixture mounted at anentry point1010. That is, the central axis of the cone is generally perpendicular to the surface of the skull at the entry point. The angle of the cone corresponds to the range of possible alignments of a guidance fixture mounted at the entry point. In this embodiment, this is a 45 degree angle. The cross-section is normal to the central axis of the cone, and passes through atarget point1012. Referring to FIG. 15b, the corresponding display shows acircular section1070 of the scanned image. Thecenter1011 and thetarget point1012 are indicated. Also indicated are two orthogonal axes. Anaxis1072 corresponds to the achievable orientations of the guidance fixture as its pivoting collar is moved in the rotating collar. Anotheraxis1074 is orthogonal toaxis1072. Motion of the rotating collar rotates the orientation of

axes

1072 and1074. These axes can be thought of as intersections of the navigational planes with the bird's eye plane of a navigational view, although here, the intersecting lines rotate with the rotation of the guidance fixture while in the navigational view, the navigation planes remain fixed as the guidance fixture is rotated. Referring to FIG. 15c, after an appropriate rotation,axis1072 passes throughtarget point1012. FIG. 15dshows the display after this rotation. Motion of the pivoting collar is indicated by aline1076, parallel toaxis1074. If the pivoting collar is centered, thenline1076 is aligned withaxis1074, as is shown in FIG. 15d. When the guidance fixture is aligned with the target point,line1076 passes through target point1064, as doesaxis1072. FIG. 15f, corresponding to FIG. 15e, shows the display after alignment is achieved. This circular field of view display provides intuitive visual feedback to the surgeon who is aligning the guidance fixture. Furthermore, displacement of the x-y table can also be shown in such a field of view display, by indicating the intersection of the resulting instrument trajectory on the circular display.

Inserting the Surgical Instrument[0113]

Referring to FIG. 16, an[0114]

instrument drive

1110 is attached tobase platter720 prior to attaching the combination ofinstrument drive1110,base platter720, and x-y table1150 toguidance base715. In FIG. 16,instrument drive1110 is shown partially mounted onto adrive post1120. Prior to attachment toguidance base715,drive post1120 is fully inserted intoinstrument drive1110 so thatinstrument drive1110 is in contact withbase platter720.Base platter720 can be displaced relative toguidance base715 in a plane orthogonal toentry column850 using two

perpendicular adjustment screws

1060, and1062 turned by x-y

table adjustment knobs

1061, and1063. Note that prior to alignment (FIG. 1, step170) the x-y table is adjusted so thatcentral opening721 inbase platter720 is centered overentry column850.

[0115]

Instrument drive

1110 includes adrive platform1130 that moves within adrive mechanism1125 along a threadedrod1132. Threadedrod1132 is oriented parallel to drivepost1120 and perpendicular tobase platter720. In this embodiment, rotation of threadedrod1132, which causes displacement ofdrive platform1130, is manual using a mechanism that is not shown. Alternative embodiments can use an electronic stepper motor or a manual hydraulic drive to rotate threadedrod1132 and thereby displacedrive platform1130.

In operation, a surgical instrument, such as a micro-electrode, is passed into the brain through a guidance tube. After alignment of[0116]

guidance fixture

710, the guidance tube is manually inserted into the brain throughcentral opening721 inbase platter720. The guidance tube is then secured inclamp1135 that is fixed relative to drivemechanism1125. The instrument is passed into the guidance tube and is secured in aclamp1133, which is fixed relative to driveplatform1130.

[0117]

Instrument LED

742 is attached to driveplatform1130. The displacement of the end of the surgical instrument frominstrument LED742 is known tolocalization application588 which executes onworkstation580. By tracking the position ofinstrument LED742, as well asplatter LEDs730, the position of the end of a surgical instrument onworkstation580 and displayed on display610 (FIG. 9) to the surgeon. The surgeon then uses this visual feedback in adjusting the depth of the instrument.

Surgical Instruments[0118]

Various types of surgical probes or instruments can be attached to drive[0119]

mechanism

1110 shown in FIG. 16. One type of instrument is an electrode, such as a recording micro-electrode or a stimulating electrode or lesioning electrode. The electrode is introduced into a rigid insertion (guidance) tube that is attached to drive mechanism,1110. Another type of instrument is a hypothermia cold probe.

In cases of movement disorder or pain surgery, a chronically implanted stimulating electrode can be placed utilizing an insertion tube. The lead, being of a smaller diameter than the insertion tube, can be slipped through the insertion tube upon removal of the drive and guide assembly, to allow fixation of the chronically implanted electrode into the brain. The electrode is secured to the skull using a compression-fitting. A chronically implanted recording electrode can similarly be placed during epilepsy surgery to monitor abnormal activity within the deep brain utilizing similar techniques.[0120]

When an instrument is to be implanted chronically, it is important that the instrument is not disturbed during the process of securing it to the skull. For instance, after a chronically implanted recording electrode has been accurately positioned using the guidance fixture, the guidance fixture must be removed before the lead of the electrode can be secured. However, the electrode can be dislodged during this process prior to securing the lead.[0121]

In order to prevent dislodging of the electrode while removing the guidance fixture, a flexible membrane is used to constrain the motion of the electrode in the burr hole. Referring to FIG. 17[0122]a, a circularburr hole ring1240 is inserted intoburr hole625 after the surgeon drills the burr hole prior to attaching mountingbase820 over the burr hole.Burr hole ring1240 has a thinelastic membrane1242 across the bottom of the ring. Therefore, an instrument that passes through the burr hole must pass throughmembrane1242 to enter the brain.Elastic membrane1242 is made of a material such as Silastic (silicone rubber) that is biocompatible and non-permeable. The membrane is self-sealing in that if it is punctured by an instrument that is then withdrawn, the membrane remains non-permeable.

After attaching[0123]

guidance fixture

710 to its mountingbase820, the fixture is aligned to direct anelectrode1250 toward thetarget point1012.Electrode1250 passes through aninsertion tube1254.Insertion tube1254 is driven throughmembrane1242 puncturing the membrane, then the electrode is driven to targetpoint1012. Alternatively, a separate pointed punch can be driven through the membrane to make a hole through which the insertion tube is subsequently inserted.

After[0124]

electrode

1250 is properly positioned at the target point,guidance fixture710 is removed, andinsertion tube1254 is removed.

Referring to FIG. 17[0125]b,electrode1250 remains secured byelastic membrane1242, preventing the electrode from being dislodged while the guidance fixture is being removed and the while the burr hole, which still hasburr hole ring1240 inserted, is exposed. Aburr hole cap1244 is then secured inburr hole ring1240. The lead ofelectrode1250 is clamped in a channel between the burr hole ring and cap, thereby preventing tension on the lead from dislodging the electrode.

Membrane

1242 is first punctured, for instance using a punch, using an insertion tube, or using the instrument itself. The instrument is inserted using the guidance fixture. After the guidance fixture is removed, an appropriate cap are secured to theburr hole ring1240.

Note that a[0127]

burr hole ring

1240 withmembrane1242 is applicable for securing instruments inserted into the brain using other methods than guided using a guidance fixture. For instance, the same burr hole ring and cap can be used when inserting an instrument freehand or using a conventional stereotactic frame.

In cases of hydrocephalus or other situations where chronic drainage of intracranial cavities is necessary, a shunt tube, such as a ventricular shunt, can be applied through the insertion tube into the target such as the ventricles of the brain. The shunt tube will have a stylet and be slipped into the insertion tube.[0128]

The insertion tube structure and its retention ring will have varying diameters, depending on the diameters of the various objects that can be placed in the insertion tube, such as the shunt tube, in this application, or micro-electrodes, in the prior application. The insertion tube, therefore, will be connected to the drive mechanism using varying sized retention rings. Referring to FIG. 16, the retention rings would be fit at[0129]

points

1133 or1135 ondrive mechanism1110. The shunt will be directed towards the target established by the software mechanism alluded to above. The shunt tube will then be secured to the skull via mechanisms described in prior art, or using an elastic membrane described above.

Alternatively, a biopsy probe can be inserted into the insertion tube by first placing a biopsy tube with a trocar/obturator through the insertion tube. The mechanism would then be directed down towards the appropriate target using the drive mechanism. The obturator would be removed, and a cutting blade will then be inserted into the biopsy tube.[0130]

In applications in which a radioactive seed for brachytherapy, a targeting nodule with a radio sensitizing, chemotherapeutic agent for external beam radiation, or a sustained release polymer drug or microdialysis capsule for local drug administration, are required for placement in a deep brain target, a different insertion tube can be connected to the[0131]

drive mechanism

1110. A delivery catheter can be placed through the insertion tube. The whole mechanism can be directed towards the deep target using the software system as alluded to above. An insertion plunger can be used to insert the object of delivery and the system is then be removed after insertion of the object. A micro-endoscope can also be inserted through the insertion tube mechanism described above and deep brain structures can be visualized prior to excision or lesioning.

X-Y Table[0132]

In certain surgical procedures, it is desirable to drive a surgical instrument along several parallel tracks. This is facilitated using x-y table[0133]1150 (FIG. 16). Before an instrument is driven toward the target, an offset is adjusted using

adjustment knobs

1061, and1063. These knobs include markings that allow precise adjustment.

An example of a procedure using penetration of an instrument along parallel tracks involves mapping the electrical activity of a region of the brain. The surgical instrument in this case is a thin electrode that is repeatedly inserted to points on a two- or three-dimensional grid. At each point, electrical activity is monitored.[0134]

Surgical Retractor[0135]

Referring to FIG. 17[0136]c, when larger masses within the brain, such as brain tumors, have to be removed with precision, the drive mechanism has a localizingsurgical retractor1210 mounted in place of the insertion tube, andbase platter1220 has a large central opening through which the retractor passes.Retractor1210 includes three ormore spatulas1212 inserted throughbase platter1220 and the entry column. Eachspatula1212 includes atracking LED1214 attached to it. The relationship of the spatulas is controlled by ascrew assembly1216 that allows the relative distance between the spatulas to be modified. Relatively small movement at the screw assembly results in a larger movement at the other ends of the spatulas due to the pivoting of the spatulas within the retractor.Tracking LEDs1214 are tracked by the camera array and the localization application computes the depth ofspatulas1212 and their displacement from the central axis. Using the tracking approach described above,surgical localizing retractor1210 is directed towards the brain target. Upon acquiring the target,screw assembly1216 is adjusted to expand localizingretractor1210 to allow visualization of the underlying brain. A variety of surgical instruments can be attached toretractor1210 in addition to using the retractor with more conventional manual techniques. These instruments can include an endoscope, an ultrasonic aspirator, an electronic coagulation/evaporator/ablator, or a laser.

Fixture Validation[0137]

An optional fixture validation step (FIG. 1, step[0138]130) can be used to confirm that the position of the tip of the surgical instrument is accurately tracked. Two types of validation can be performed. Referring to FIG. 18,guidance fixture710 is attached to anupper mounting plate1334 of acalibration jig1330. Prior to attachingguidance fixture710 tocalibration jig1330, pivoting locking knob846 (FIG. 10) is loosened allowing pivotingcollar840 to pivot. Afterguidance fixture710 is attached, pivotingcollar840 is centered and pivotinglocking knob846 is tightened. Aguidance tube1340 is clamped into the guidance fixture, and asurgical instrument1342 is passed through the guidance tube.Guidance tube1340 protrudes below upper mountingplate1334. Aruler1335 can then be used to measure the depth of penetration of the guidance tube. Similarly,rule1335 can be used to measure the penetration ofsurgical instrument1342.

Referring to FIG. 19, a validation (or “phantom”)[0139]

jig

1312 can also be used.Tracking MIRRF510 is attached tovalidation jig1312.Guidance fixture710 is be mounted onvalidation jig1312. Aphantom target point1320 at a known position relative tovalidation jig1312, and therefore at a known position relative to the fiducial points on trackingMIRRF510, is chosen. Thelocalization application588 is programmed with the phantom target position. Using the procedure that will be used during the surgical phase, the surgeon performs the registration and alignment steps and then drives the instrument throughguidance fixture710. if the tip of the instrument is coincident with the phantom target point, thenguidance fixture710 is validated. If for some reason the instrument is not coincident with the phantom target point, for example, due to improper attachment of the instrument to the drive assembly resulting in an incorrect depth calibration, the surgeon readjusts the instrument and attempts the validation step again.

Alternative Scanning, Registration, and Tracking[0140]

Other embodiments of the invention use alternative scanning, registration, and tracking markers, and methods of scanning and registration.[0141]

In the first embodiment, scanning[0142]

MIRRF

310 and trackingMIRRF510 are star-shaped. Other alternative shapes of MIRRFs can be used. Referring to FIG. 20, an arc-shapedMIRRF1410 is attached to threadedinserts1420 usingbolts1430, and marking and locking nuts1432. Arc-shapedMIRRF1410 includes scanningfiducial markers1412. The fiducial markers are more widely spaced than in star-shaped

MIRRFs

310, and510, resulting in a more accurate tracing of the MIRRF. During insertion of threadedinserts1420, arc-shapedMIRRF1410 acts as a template for accurate positioning of the threaded inserts.

In embodiments described above, threaded inserts are inserted into the skull to provide the fixed points of attachment for MIRRFs. Alternative embodiments use of the types of anchors or forms of mechanical attachment, for example, including protruding posts that are attached to the skull. A MIRRF is then attached to the posts.[0143]

Another alternative method of attachment uses subcutaneous anchors. Referring to FIG. 20[0144]a, aninsert1420ain fixed in the skull.Insert1420ahas a divot in its head, which provides an accurate position reference. Afterinsert1420 is attached to the skull,skin211 is secured over the insert. At later times, these divots are used to mate clampingposts1430aon a MIRRF, which hold the MIRRF in place. Since implanted divots are covered by the skin, they can remain in place for an extended period of time.

Such a subcutaneous insert allows repeated reattachment of a fixture, such as a scanning or tracking MIRRFs, or repeated reattachment of a guidance fixture itself. An application of such periodic reattachment is periodic microrecording from a particular location in the brain, or repeated lesioning of particular brain structures.[0145]

Subcutaneous inserts also allow other devices, including stereotactic radiation devices, to be repeatedly reattached at precisely the same location. These devices include the Gamma Knike, Lineal Accelerator (LINAC), or a multi-collimated machine, such as the PEACOCK device. This approach to reattachment provides greater precision than is possible using bite plates or facial molds to reposition the devices.[0146]

An alternative to use of a MIRRF is to attach markers directly to anchors in the skull. Referring to FIG. 21, each such anchor, shown as threaded[0147]

insert

1440, can support asingle scanning marker1444 on apost1442, subsequently support asingle registration divot1450 on asecond post1451, and then support a single tracking marker,LED1448, on athird post1446. The geometric relationship of the anchor to the scanning marker is the same as the geometric relationship of the anchor to the tracking marker thereby allowing a localization application to directly track the fiducial points by tracking the location of the tracking marker.

Using any of the MIRRF structures described, multiple MIRRFs can be used to provide increased accuracy in registration and tracking. For example, two star-shaped MIRRFs can be used, one on each side of the head.[0148]

In other embodiments, alternative attachment methods can be used to secure a guidance fixture to the skull. For instance, the mounting base can be relatively small and have extended “legs” extending radically and secured to the skin or skull with sharp points. These legs provide stabilization that may not be achievable using mounting screws through the smaller mounting base. The mounting base can alternatively include an insert that fits into the burr hole. This insert can also be threaded to allow direct attachment of the mounting base to the burr hole.[0149]

In other embodiments, threaded inserts are used to attach, and subsequently accurately reattach, conventional stereotactic frames. This allows the conventional stereotactic frame to be removed and then accurately reattached to the skull. Procedures, such as fractionated multi-day stereotactic radiation treatments could then be performed with the stereotactic frame being reattached for each treatment.[0150]

Referring to FIG. 22, a modified guidance fixture[0151]1510 is used in combination with a conventionalstereotactic frame1520. Guidance fixture1510 includes an x-y positioning table withLEDs1512 and an instrument drive with an LED1514 for tracking the depth of the surgical instrument. The guidance assembly is positioned onframe1520 to align with the planned surgical trajectory. A trackingMIRRF1530 is attached to frame1520 to allow dynamic tracking.

Rather than using a scanning MIRRF with scanning fiducial markers, or scanning fiducial markers attached directly to anchors embedded in the skull, alternative embodiments can use other features for registration. In one alternative embodiment, paste-on scanning markers are attached to the skin. During the registration phase, the cranial probe is positioned at each of the paste-on markers in turn, rather than at the fiducial points on a MIRRF. Tracking LEDs are attached in a fixed position relative to the skull in some other way than using a MIRRF, for example, using an elastic headband. Rather than using pasted on fiducial markers, another alternative embodiment uses accessible anatomical features. These features are located in the scanned image, and the probe is positioned at these features during the registration phase. Still another alternative does not use discrete fiducial points, but rather makes use of the surface shape of the skull in a “surface merge” approach. The surface of the skull is located in the three-dimensional image. During registration, the cranial probe touches a large number of points on the skull. The locations of these points is matched to the shape of the skull to determine the conformal mapping from the physical coordinate system to the image coordinate system.[0152]

In yet another embodiment, referring to FIG. 23, a tracking[0153]

MIRRF

1610 can be attached directly to the base of aguidance fixture710. TrackingMIRRF1610 is only useful for tracking afterguidance fixture710 has been attached to the skull. In this approach, registration is based on fiducial points elsewhere on the skull than trackingMIRRF1610.

Locating the entry point, over which[0154]

guidance fixture

710 is attached can be accomplished using one of a variety of alternative techniques. For example, the entry point may be known for some standardized procedures. Alternatively, the entry point may be determined by registration of the skull and the three-dimensional image based on fiducial markers attached to the head, for example using adhesive pads, anatomical markers, or a “surface merge” technique as described above.

Once the guidance fixture and tracking[0155]

MIRRF

1610 are attached to the skull,LEDs1620 on trackingMIRRF1610 are used to track the location of the skull, and thereby track the location of the surgical instrument. A reregistration step (FIG. 1, step160) can be performed to determine the relative position of the fiducial points toLEDs1620.

Various mechanical adjustments of[0156]

guidance fixture

710, if performed when an guidance tube is inserted in the brain, would potentially damage the brain tissue. The guidance fixture optionally includes a feature that the various locking knobs and x-y adjustment knobs are rotated using a removable knob (or key). When not in use, this knob is stowed on the drive assembly. Whenever the removable knob is removed from its stowed position, the signal from an electrical sensor on the drive assembly that is connected to the workstation causes a warning, for example on the computer display, to be provided to the surgeon.

Instrumented and Actuated Guidance Fixtures[0157]

In general, the embodiments of the guidance fixture described above rely on a surgeon manually adjusting the guidance fixture and driving a surgical instrument into the body based on visual feedback. The manual steps carried out by the surgeon include adjusting the orientation of rotating collar[0158]830 (FIG. 10) with respect to mountingbase820, and adjustingpivoting collar840 by turningadjustment knob844. The surgeon also adjusts x-y table1150 (FIG. 10) by turning x-ytable adjustment knobs1061 and1063 (FIG. 16). The visual feedback which is presented to the surgeon on a computer display is computed using remote sensing of the location and adjusted orientation of the fixture. As described previously, the remote sensing of the guidance fixture is based on determining the locations of tracking markers attached to the fixture as well as of tracking markers attached to the head.

As an alternative to using a remote sensing approach for determining the position and orientation of the guidance fixture relative to the body to which the fixture is attached, an instrumented guidance fixture can be used. In an instrumented guidance fixture, the position and orientation or the guidance fixture as well as the position of the surgical instrument relative to the guidance fixture are determined using sensors which directly encode the configuration of the fixture. The outputs of these sensors are used to compute the image which is provided as feedback to the surgeon. For instance, electrical rotary and linear encoders are used to generate electrical signals that are passed from the guidance fixture to the workstation that computes the visual feedback that is presented to the surgeon.[0159]

Referring to FIG. 24[0160]a, an instrumentedguidance fixture2400 includes five electrical sensors, two that encode the angles of rotation ofrotating collar830 and pivoting collar840 (sensors2410), two for the x and y displacements of x-y table1150 (sensors2412), and one for the displacement of instrument drive platform1130 (sensor2413).

Referring to FIG. 24[0161]b, aworkstation580 accepts and storessensor signals2430 from sensors2410-2413 (not shown in FIG. 24b) on instrumentedguidance fixture2400. Afixture tracking application2432 executing onworkstation580 takessensor signals2430 and computes fixture/instrument location2434, which includes the location and orientation of theguidance fixture2400 and of the surgical instrument (if an instrument is inserted in the drive of the fixture). These orientations and locations are computed in the frame of reference of the base ofguidance fixture2400.

A[0162]

display application

2436 combines fixture/instrument location2434 with a previously computedbase location2442, which includes the location and orientation of the base ofguidance fixture2400 in the frame of reference of the scannedimage410, to compute the orientation and location of the guidance fixture and the instrument in the frame of reference of the image.Display application2436 then combines this computed location and orientation withimage410 to formcomposite image2444, which shows representations of the fixture and instrument in conjunction with one or more views of the scanned image.Composite image2444 is shown ondisplay610, which provides visual feedback to the surgeon who manipulates the guidance fixture and the instrument.

Note that the[0163]

fixture tracking application

2432 executed onworkstation580 relies onbase location2442, which includes knowledge of the location and orientation of the base ofguidance fixture2400 in the frame of reference of the head. Note also, that once the base ofguidance fixture2400 is attached to the head,base location2442 remains fixed as long as the base remains firmly attached. Therefore,workstation580 does not require ongoing updating ofbase location2442 once it is initially established.

Referring still to FIG. 24[0164]b, one method of establishingbase location2442 is illustrated. In this illustration, using an approach similar to the registration approaches described previously, a trackingMIRRF510 is attached in a known location relative to a scanning MIRRF that was attached during scanning. Using aprobe570 that is tracked usingcamera array560, the body and image are first registered. In particular, the tip ofprobe570 is first touched to known locations onMIRRF510 such as divots at the locations corresponding to locations of scanning markers. Aremote localization application2440 compares the locations of the tip of the probe with the coordinates of the scanning markers in the image. This comparison is used establish a conformal mapping between the body and image reference frames. Then the tip of the probe is touched to a set of predetermined points on the base ofguidance fixture2400.Remote localization application2440 uses the locations of the points on the base and the conformal map to establishbase location2442.

Using this procedure, once the base has been fixed to the head, and[0165]

base location

2442 has been determined, there is no need to further trackMIRRF510 with the camera array. The patient can move around and, as long asworkstation580 receives the signals fromsensors2410,display610 can provide feedback to the surgeon.Sensors2410 can be coupled toworkstation580 in a number of ways, including usingwires2420 carrying electrical sensor signals. Alternatively, signals passing through optical fibers, or radio or optical signals transmitted through the air from the patient to a receiver attached to the workstation, can be used. In any of these cases, the patient is free to move around, as long as the sensor signals are passed to the workstation.

Separate from instrumentation of a guidance fixture, a guidance fixture can be actuated as an alternative to requiring that the guidance fixture be manually adjusted. Referring to FIG. 25[0166]a, an actuatedguidance fixture2500 includes astepper motor2513 that is couple to driveplatform1130. Rotation ofstepper motor2513 raises or lowers the drive platform, thereby displacing an attached instrument. The linear displacement of the drive platform is directly related to the angular rotation of the stepper motor. Actuated guidance fixture also includes

motors

2510 and2511, that rotate and pivot the guidance fixture, and twomotors2512 which adjust x-y table1150.

Referring to FIG. 25[0167]b, in one version of remote actuation of the guidance fixture, the surgeon providesmanual input2532 to acontroller2530 by manipulating manual controls.Controller2530 converts these manual inputs intocontrol signals2540 for driving motors2510-2513. The surgeon relies on visual feedback, as in the previously described approaches, as he manipulates the manual controls.

Alternative versions of actuated[0168]

guidance fixture

2500 can use different types of motors. For instance, hydraulic motors can be used and the guidance fixture and the controller can be coupled to the guidance fixture by hydraulic lines. This hydraulic approach provides electrical isolation between the patient and the workstation. Also, the entire guidance fixture and hydraulic motors can be fabricated from materials that do not interfere with scanning. This allows use of such an actuated fixture during scanning, which is useful in certain operative procedures.

Control signals provided to actuators on the guidance fixture can also be used to determine the configuration of the fixture. For instance, in controlling a stepper motor, the number of discrete “steps” commanded by a controller can be counted to determine the angle of rotation of the motor. This computed angle can be used in addition to, or even instead of, signals from sensors on the fixture.[0169]

Referring to FIG. 26, a[0170]

guidance fixture

2600 is both instrumented with sensors2410-2413 (not shown) and actuated with motors2510-2513 (not shown).Sensor signals2430 are provided to aworkstation580 from sensors2410-2413. The workstation computesmotor control signals2540 which are used to drive motors2510-2513. In this arrangement, acontrol application2650 executing onworkstation580 usessensor signals2430 as feedback information and controls the guidance fixture by generating motor control signals2540.Control application2650 also acceptsbase location2442 which allows it to compute the location and orientation of the fixture in the frame of reference of the image or the body.

[0171]

Control application

2650 acceptscommands2620 from the surgeon. These commands can range in complexity. An example of a simple command might be to displace a surgical instrument to a particular depth. A more complex command might be to align the guidance fixture with a planned target location. In the latter case,control application2650 uses a storedtarget location2610 and controls motors2510-2513 to align the fixture. Even more complex commands can be used to invoke entire preprogrammed procedures. An example of such a preprogrammed procedure is to map a region of the brain by repeatedly positioning the x-y table and inserting and then withdrawing a recording electrode.

In addition to angular and position sensors, force sensors can be incorporated into an instrumented guidance fixture. Referring still to FIG. 26,[0172]

control application

2650 can providefeedback signals2621, including force feedback signals, to the surgeon.

Teleoperation[0173]

An actuated guidance fixture, such as actuated[0174]

guidance fixture

2500, or actuated and instrumentedguidance fixture2600, described above, are applicable to telerobotic surgery in which the surgeon is distant from the patient. A surgical nurse, physician's associate, or some other assistant to the surgeon is in the some location as the patient. This assistant performs some functions, such as attaching the guidance fixture to the patient, but does not perform the actual surgery.

Referring to FIG. 27, a three-[0175]

dimensional image

410 is produced by scanning a patient. Before scanning, the assistant has attached scanning markers, such as the scanning MIRRF described previously, to the patient. The image is sent toworkstation580 through a pair of

transceivers

2710,2712, one located near the patient, and one near the surgeon. The transceivers can be coupled by various types of channels, including a radio channel, or a data network connection. The surgeon locates the scanning markers in the image, and plans the surgical trajectory.

At the beginning of the surgical phase, the assistant locates the entry point and attaches an instrumented and actuated[0176]

guidance fixture

2600 to the patient. After the fixture is attached, signals from the sensors are transmitted toworkstation580 through

transceivers

2710,2712, and control signals are transmitted back fromworkstation580 through the transceivers to the fixture. In addition, images fromcamera array560 are transmitted to the workstation. A registration step is carried out, in this case using a probe which is tracked bycamera array560.

Once[0177]

guidance fixture

2600 is attached and registered, the surgeon controls the fixture remotely. Based on the sensor signals from the guidance fixture,workstation580 computes images which are presented ondisplay610 as visual feedback to the surgeon. The surgeon can interact with the workstation in a number of ways. in FIG. 27, amanipulator2750 is coupled toworkstation580. The manipulator includes a “phantom” jig and a manipulator fixture that is similar to the guidance fixture that is attached to the patient's head. The surgeon adjusts the manipulator fixture which provides control signals to ateleoperator application2740 executing onworkstation580.Teleoperator application2740 converts these control signal to motor control signals forguidance fixture2600 and transmits the motor control signals to the guidance fixture. If the sensors on the guidance fixture include force sensors,teleoperator application2740 receives force signals fromguidance fixture2600 which are used to controlmanipulator2750 to provide for feedback to the surgeon.

During the surgery, the assistant is responsible to tasks such as attaching the guidance fixture, exchanging instruments in the guidance fixture, and surgical tasks such as opening the skull and closing the skin.[0178]

Various[0179]

alternative manipulators

2750 can be used to provide a physical interface for the surgeon. For instance a joystick or a three dimensional pointer (e.g., an instrumented glove) can be used in conjunction with a head-mounted display in a virtual reality based arrangement.

Alternative Registration[0180]

In the approaches described above, in general, registration is performed using a remote sensing approach. The registration procedure is used to determine a conformal map between a coordinate system that is fixed relative to the body and the coordinate system of the scanned image. Alternative registration procedures do not rely on remote sensing. These registration procedures also include steps for determining the location and orientation of an attached base of a guidance fixture. If an instrumented guidance fixture is used, remote sensing is not required after the registration procedure is completed.[0181]

In one alternative approach illustrated in FIG. 28, initial registration and location of the mounting base is performed by securing the body in a fixed location relative to the base of an articulated[0182]

arm

2820. For example, a head can be secured using aconventional head frame2810. The angles in thejoints2822 of articulatedarm2830 provide signals toworkstation580 which are used to determine the location of the end of the arm relative to the base.

The procedure for determining the location and orientation of the base in the image coordinate system is as follows. Articulated[0183]

arm

2820 is coupled toworkstation580 and providesarm signals2850, which encode the joint angles of the arm, to the workstation. Abase localization application2852, which executes onworkstation580, determines the coordinates of the end point of the arm in the reference frame of the base of the arm. In a first phase of the procedure, the surgeon touches the end point of the arm to each of a set offiducial points2832. Correspondingly, fiducial point coordinates421 are stored onworkstation580. Using fiducial point coordinates421 and the coordinates of the fiducial points in the reference frame of the arm,base localization application2852 computes a conformal map between the image coordinate system and the arm coordinate system.

The second phase of the procedure, the surgical phase, involves three steps. First, the surgeon locates an entry point by pointing with the end of the arm and viewing the display to select an entry point. Next, the surgeon drills the burr hole at the entry point and attaches the mounting base. Finally, the surgeon touches the end of the arm to a set of predetermined points on a guidance fixture mounting base that has already been attached to the head. Using the locations of these points relative to the base of the arm and the conformal map computed in the first step,[0184]

base localization application

2852 computesbase location2442.

In another alternative to registering the mounting base, a miniaturized mechanical arm is attached directly to the body, thereby not requiring the patient to be restrained during the registration and base localization procedure. The procedure is carried out as follows.[0185]

Referring to FIGS. 29[0186]a-b, abone anchor2910 is fixed in the skull prior to scanning. Using scanning markers attached tobone anchor2910, the locations and orientations of the bone anchors in the coordinate system of the image are determined after the scan is obtained. The attached scanning markers are such that the orientation as well as location of each bone anchor can be determined. For instance, a small array of scanning markers can be attached to each bone anchor, and the rotation of the array can be constrained by the position of anindex point2912 on the bone anchor.

A[0187]

miniature arm

2920 is attached tobone anchor2910. In particular, anarm base2922 is attached tobone anchor2910.Base2922 mates withindex point2912 thereby constraining its rotation about the central axis of the bone anchor. Since the location and orientation of the bone anchor was previously determined form the scanned image, a conformal map between the reference frame ofminiature arm2920 and the image reference frame is computed without requiring any registration step. The surgeon can touch a set of fiducial points to verify the accuracy of the conformal map.

Referring to FIG. 29[0188]a,miniature arm2920 includes an instrumental joint2923 through which ashaft2924 passes.Joint2923 allows four degrees of freedom. These degrees of freedom are (a) rotation around a control axis of base2922 (i.e., around the central axis of bone anchor2910), (b) elevation relative to the base, (c) rotation of the shaft along its axis, and (d) extension of the shaft.Joint2923 includes sensors which generates signals encoding these four motions. These signals are provided to workstation580 (not shown in FIGS. 29a-b). Apointer2926 is rigidly attached toshaft2924, For any position of the tip ofpointer2926,workstation580 computes the coordinates of the tip relative toarm base2922. Using the conformal map, the workstation then computes the coordinates of the tip of the arm in the reference frame of the image.

Referring to FIG. 29[0189]b,miniature arm2920 is used to locateentry point2930 and subsequently registering a mounting base attached over the entry point.

Alternatively, referring to FIGS. 29[0190]c-d

mounting base

2940 can be directly attached toshaft2924. In this way, an entry point is selected by moving the mounting base, and attaching the base to the skull while it is still attached toshaft2924.

After the instrumented guidance fixture is attached to the mounting base, the arm is no longer required and can be removed from the bone anchor.[0191]

Spinal and General Surgery[0192]

Another aspect of the invention relates to spinal and general surgery. These approaches include several steps that are in common with the approaches to brain surgery described above.[0193]

In spinal surgery, the approach is useful for complex spinal procedures, such as implantation of vertebral pedicle fixation screws for fusion. Clinical conditions in which this approach may be useful include degenerative disc and bone disease, tumor, trauma, congenital or developmental abnormalities, and infection.[0194]

Referring to the flowchart in FIG. 30, in spinal surgery, the procedure follows a similar sequence of steps as in the brain surgery procedure shown in FIG. 1. Referring to FIGS. 31[0195]a-b, thespine1910 is scanned to produce a three-dimensional spinal image (step1810). Rather than attaching scanning markers to the body prior to scanning, fiducial points are anatomical points of spinal structure that can be located both onspine1910 during surgery and in the spinal image. Fiducial coordinates of these anatomical points are determined in the same manner as fiducial coordinates of images of scanning markers are found in the previously described brain surgery procedures, for example by manually positioning a cursor on a display of the spinal image (step1815). One or more target points are also located in the three-dimensional spinal image (step1820).

During the surgical phase of the procedure, the patient is positioned on an operating table and[0196]

spine

1910 exposed. The patient's position is adjusted so that the curvature of the patient'sspine1910 matches the curvature in the spinal image in as close a fashion as possible. For instance, the surgeon matches an actual interspinous distance equal to the corresponding interspinous distance in the scanned image.

A tracking[0197]

MIRRF

1940 is attached to aspinous process1912 by aspinous clamp1932 and a clamping post1934 (step1825).Spinous process1912 is, in general, the most rostral of the spinous processes to be studied during a posterior spinal surgical approach.MIRRF1940 has a similar shape to tracking MIRRF510 (FIG. 5), althoughMIRRF1940 can have a variety of shapes.MIRRF1940 includes trackingLEDs1942.

A longitudinal[0198]

spinal rail

1930 is also attached to exposed spine1910 (step1830). One end ofspinal rail1930 is attached tospinous process1912 byspinous clamp1932. A secondspinous clamp1933 is used to secure the other end ofspinal rail1930 to anotherspinous process1913. Longitudinalspinal rail1930 has distance markers that are used to measure the separation of

spinous clamps

1932 and1933 to allow the surgeon to obtain an appropriate correspondence to the patient□s position and spine curvature at the time of scanning (step1835). Various sizes of longitudinal spinal rails can be used depending on how many segments of spine are to be operated upon.

A registration step is then carried out (step[0199]1840). A probe with probe LEDs attached to it is tracked using a camera array. In a procedure similar to that described above for brain surgery, the coordinates of the fiducial points in the reference frame ofMIRRF1940 are computed after positioning the probe at the fiducial points. These are matched to the fiducial coordinates found in the spinal image. Registration can be performed using fiducial points on only one segment ofspine1910. Because the curvature of the spine during surgery is adjusted using longitudinalspinal rail1930 to match the curvature in the spinal image, the remaining segments ofspine1910 between

spinous processes

1912 and1913 are also accurately registered. Fiducial points on multiple segments ofspine1910 can also be used for registration. If the geometric relationship between the fiducial coordinates in the spinal image does not match the geometric relationship of the coordinates of the fiducial points in the reference frame of MIRRF1940 (step1845), one possible source of error is inadequate matching of the curvature of the spine to the curvature at the time of scanning. In the case of inadequate matching of the curvature, the surgeon can readjust longitudinal spinal rail1930 (step1835) and attempt the registration step again until an adequate conformal mapping can be computed.

A lateral[0200]

spinal rail

1950 is then attached to longitudinalspinal rail1930 using a mobile rotatory joint1952. Attached to lateralspinal rail1950 is aguidance fixture1960.Guidance fixture1960 includes aplanar base1962 and trackingLEDs1964 of similar structure to guidance fixture710 (FIG. 9).Guidance fixture1962 does not, in general, include a guidance tube. A mountingbase1966 ofguidance fixture1960 clamps to lateralspinal rail1950.

Exemplary spinal surgical procedures involve insertion of a pedicle screw and insertion of an intervertebral fixation cage into[0201]

spine

1910 for spinal stabilization and fusion. These surgical procedures proceed as follows.

[0202]

Guidance fixture

1960 is positioned over the targeted position by sliding lateralspinal rail1950 along longitudinalspinal rail1940 and securely tightening mobile rotatory joint1952, and then securely tighteningguidance fixture1960 in position on lateral spinal rail1950 (step1850). An example of a targeted position is the left pedicle of the L1 vertebral body.

A trajectory from[0203]

guidance fixture

1960 to the targeted position is then replanned (step1855). The replanned trajectory can be checked to verify that it avoids critical neural structures.Guidance fixture1960 is then aligned using the two-step rotation and pivoting procedure described above, using visual feedback in a navigational view (step1860).

If the surgical procedure involves pedicle screw fixation, a drill is introduced through[0204]

guidance fixture

1960 and a hole is drilled through the pedicle into the vertebral body, without violating any critical neural structure. The pedicle screw is then introduced into the pedicle through the guidance fixture1960 (step1865). As with the instrument drive used for brain surgery, the drill can include a tracking LED attached to it for tracking insertion of the drill.

If the procedure involves another target on the spine (step[0205]1870), mobile rotatory joint1952 andguidance fixture1960 are then loosened, and lateralspinal rail1950 andguidance fixture1960 are slipped over to the next appropriate target and the above procedure is repeated. In this fashion, rapid insertion of pedicle screws is accomplished.

If the surgical procedure involves insertion of intervertebral fixation[0206]

cages guidance fixture

1960 is targeted towards a disc space. The disc is removed throughguidance fixture1960 using a standard disc removal system. The fixation cage is then inserted usingguidance fixture1960 into the intervertebral space.

In the surgical procedure involves percutaneous spinal fixation, incisions are made to expose[0207]

spinous processes

1912,1913 and longitudinalspinal rail1930 andMIRRF1940 are attached as described above. After registration using one or both of the exposed spinous processes,guidance fixture1960 is attached and aligned on a trajectory through the pedicle or the intervertebral disc space. A small incision is made in the skin underneathguidance fixture1960. An insertion tube is then be placed throughguidance fixture1960 so as to rapidly dissect through muscle and direct along the trajectory path and directed towards the pedicle or the intervertebral disc space. Using the techniques described above, the pedicle screws or intervertebral fixation cages can then be applied.

An alternative method of registration in spinal surgery uses instrumented miniature arm[0209]2920 (FIG. 29a) is attached to the longitudinal spinal rail, rather than to abone anchor2910 as in the case of brain surgery. In a registration step, the surgeon positions the tip ofarm2924 at multiple anatomical point. Using the configuration of the arm when touching the points, the localization application executing on the workstation determines the location and orientation of the arm relative to the spine. The miniature arm is then used to orient the base of the guidance fixture. Since the base of the arm is at the known location and orientation relative to the spine, and the guidance fixture is at a known location and orientation relative to the base of the arm, the localization application can compute the location and orientation of the guidance fixture relative to the spine. This location and orientation is then displayed to the surgeon.

General Surgery[0210]

Another aspect of the invention relates to general surgery, such as abdominal surgery. Referring to FIGS. 32[0211]a-b, the approach is applicable, for example, for biopsy and draining of aliver cyst2017. Referring to FIG. 32a, prior to scanning, abase plate2010 is attached to thepelvis2015, or another fixed bony structure, utilizing a percutaneous technique using several screws. Ascanning MIRRF2020 is attached to acolumn2012 which is attached tobase plate2010. A scan of the patient is taken. A target is located in the scanned image within the body, in this example within theliver2016.Column2012 and scanningMIRRF2020 are removed, andbase plate2010 is left attached to the patient.

Referring to FIG. 32[0212]b, at the time of surgery,column2012 is reattached tobase plate2010 and a trackingMIRRF2022 of the same geometry as scanningMIRRF2020 is attached tocolumn2012. Registration of the tracking MIRRF with the image is performed using a surgical probe as in the brain surgery registration procedure described above.

In an approach similar to that used for spinal surgery, a[0213]

guidance fixture

2030 is attached tocolumn2012 using arod2032 and a clamp. Using the trajectory replanning and two-step alignment procedure described above,guidance fixture2030 is aligned with the planned target.

A small incision is made in the skin along the instrument trajectory. A[0214]

guidance tube

2035 is then inserted throughguidance fixture2030 towards the target. A variety of general surgical instruments, such as an optical fiber for endoscopic visualization, an excision device, a vascular coagulator, a biopsy tube, or a drainage tube, can be passed through the guidance tube. The depth of penetration of the instrument is tracked using a workstation and displayed to the surgeon.

As an alternative to attaching[0215]

column

2012 to a base plate attached to the pelvis,column2012 can be attached to aninferior rib2018 near the liver on the right upper quadrant of the abdomen, both anteriorly and posteriorly.

If a second surgical instruments is necessary, a secondary guidance fixture can attached to[0216]

column

2012 and aligned by the same technique, and the second instrument passed through the secondary guidance fixture and through a second incision. Multiple instruments can be placed in this manner using multiple guidance fixtures.

Head-Mounted Camera Array[0217]

In yet another alternative approach directed to stereotactic brain surgery, a lightweight camera array is attached directly to anchor screws mounted in the skull, as shown in FIG. 33. The camera array is used to track the location and orientation of a guidance fixture, probes, and instruments relative to the head. Since the cameras move with the patient, the patient can be free to move around without requiring separate tracking of the patient in order to compute the relative displacement of instruments relative to the patient.[0218]

Using this approach, two or more bone anchors[0219]1700 are attached to the skull. Scanning markers are attached toanchors1700 and the patient is scanned producing a three-dimensional image. Using techniques described above, the location and orientation of each bone anchor is determined from the scanned image.

At the time of surgery, carbon-fiber, acrylic or similar[0220]

removable posts

1710 are attached to each of the bone anchors1700. An array ofcameras1720, using CCD cameras with short focal-length lens, are fixed to the posts, directed roughly towards the skull.

[0221]

Cameras

1720 serve the purpose of camera array560 (FIG. 5) in the approaches in which the patient is free to move relative to the camera array. In this approach, although free to move around, the patient is essentially fixed relative to the cameras. There is therefore no need to track both the body and the guidance fixture since the body doesn't move relative to the cameras. Moreover, the locations and orientations ofanchors1700 in the image reference frame are determined by locating the scanning markers that are attached to these anchors prior to scanning. Since the geometry ofposts1710 is also known, the locations of the camera in the reference frame of the image are known. Essentially, the conformal map between the image reference frame and the camera reference frame can be pre-computed given the locations and orientations of the bone anchors. The location of an LED in the camera reference frame is determined from the digitalized images produced bycameras1720 and then transformed to the image reference frame. In this way the location and orientation ofguidance fixture710 is tracked without requiring the surgeon to carry out explicit registration steps.

As an alternative to mounting the cameras on[0222]

posts

1710, other types of mounting fixtures can be attached toanchors1700. For instance, a single fixture can be mounted to multiple anchors. Also, a customized mounting fixture can be fabricated to position the cameras in a known position relative to the anchors.

Alternative Embodiments[0223]

In the above embodiments, tracking LEDs are tracked using a camera. Other alternative embodiments can use other three-dimensional sensing and tracking approaches. Rather than LEDs, other tracking markers that are active emitters of electromagnetic or mechanical energy such as electronic sparks, heat, magnetic energy, or sound can be used. Appropriate three-dimensional tracking approaches, for example, using imaging or triangulation techniques determine the three-dimensional coordinates of the emitters. Alternatively, tracking markers that are passive reflectors or transducers of externally applied localizing energy, such as infrared light, sound, magnetism, can be used.[0225]

The devices described above can be made of a variety of materials. One alternative is to use a material, such as carbon fiber, which does not interfere with MRI scanning. This allows use of the devices during intraoperative MRI scanning. Also, use of hydraulic drive mechanisms rather than electrical motors avoids interference with MRI scanning.[0226]

In the surgical procedures described above, the patient is not necessary immobilized. It may be desirable, however, to immobilize the patient, for example by clamping the guidance fixture to an operating table, at some times during the surgery.[0227]

It is to be understood that the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims.[0228]

Claims

What is claimed is:

1. An apparatus for stereotactic surgery on a spine comprising:

a guidance fixture including an instrument guide for moving a surgical instrument along a constrained trajectory;

a mounting device including a longitudinal rail and a plurality of clamps for securing the longitudinal rail to the spine;

an adjustment mechanism for adjusting a location and an orientation of the constrained trajectory relative to the mounting device; and

a signaling device for providing signals related to the location and the orientation of the constrained trajectory.

2. An apparatus for stereotactic surgery on a body, comprising:

a guidance fixture, including

(a) an instrument guide for moving a surgical instrument along a constrained trajectory relative to the instrument guide,

(b) an adjustable portion supporting the instrument guide, including a base having a central axis and an adjustment mechanism coupled between the base and the instrument guide, wherein a configuration of the adjustment mechanism determines an orientation of the instrument guide relative to the central axis of the base, and

(c) a signaling device for providing a signal representation of the configuration of the adjustment mechanism; and

a mounting device coupled to the guidance fixture for attaching the guidance fixture to the body, the mounting device including an attachment portion for rigid attachment to a bone structure of the body.

3. The apparatus ofclaim 2 wherein the attachment portion of the mounting device includes a first clamp for attaching the mounting device to a first point on a spine, and the mounting device further includes a longitudinal rail.

4. The apparatus ofclaim 3 wherein the attachment portion includes a second clamp for attaching the mounting device to a second point on the spine.

5. The apparatus forclaim 3 wherein the mounting device further includes a transverse rail coupled between the longitudinal rail and the guidance fixture and an adjustable coupler coupling the longitudinal rail and the transverse rail.

6. The apparatus ofclaim 2 wherein the mounting device further includes a tracking device which when the mounting device attached to the body is rigidly coupled to the body, the tracking device providing a signal representation of a position of the body.

7. The apparatus ofclaim 6 wherein the tracking device includes a plurality of tracking markers and the signal representation of the position of the body includes a plurality of signals propagating from corresponding tracking markers.

8. The apparatus ofclaim 7 wherein the signals propagating from the tracking markers are electromagnetic signals.

9. The apparatus ofclaim 8 wherein the tracking markers are light emitting diodes and the signals propagating from the tracking markers are optical signals.

10. The apparatus ofclaim 7 wherein the signals propagating from the tracking markers are acoustic signals.

11. The apparatus ofclaim 2 wherein the mounting device further includes and an adjustable portion coupling the attachment portion to the guidance fixture.

12. The apparatus ofclaim 2 wherein the attachment portion includes a mounting plate for attaching the mounting device directly to a bone structure of the body.

13. The apparatus ofclaim 12 wherein the mounting device further includes a rod removably attached to the mounting base.

14. A method for stereotactic spinal surgery comprising:

attaching a longitudinal rail to a spine;

registering the longitudinal rail, including locating a plurality of anatomical fiducial points on the spine in relation to the longitudinal rail;

providing an adjustable guidance fixture that includes an instrument guide for guiding the surgical instrument along a constrained trajectory relative to the instrument guide;

attaching the adjustable guidance fixture to the longitudinal rail;

tracking a location and an orientation of the instrument guide relative to the longitudinal rail; and

adjusting the orientation of the instrument guide such the constrained trajectory passes through a target in the body.

15. The method ofclaim 14 further comprising driving the surgical instrument along the constrained trajectory toward the target.

16. The method ofclaim 14 wherein attaching the longitudinal rail to the spine includes attaching said rail to a first spinous process.

17. The method ofclaim 16 wherein attaching the rail to a first spinous process includes clamping said rail to said spinous process.

18. The method ofclaim 17 wherein attaching the longitudinal rail to the spine further includes attaching said rail to a second spinous process.

19. The method ofclaim 18 wherein attaching the longitudinal rail to the spine further includes adjusting the separation of the first and the second spinous processes to match a desired curvature of the spine.

20. The method ofclaim 19 wherein attaching the longitudinal rail to the spine further includes verifying locations a plurality of anatomical fiducial points on the spine in relation to the longitudinal rail.

21. The method ofclaim 14 further comprising attaching a tracking device to the rail, and locating the anatomical points in relation to the rail includes locating the tracking device and the anatomical points using a remote sensing device.

22. The method ofclaim 14 wherein including locating a plurality of anatomical fiducial points on the spine in relation to the longitudinal rail includes:

tracking a location of the longitudinal rail with using a remote sensing device;

tracking a location of a probe positioned at each of the fiducial points using the remote sensing device; and

comparing the location of the probe and the location of the longitudinal rail at each of the fiducial points.

23. The method ofclaim 22 further comprising attaching a tracking device to the rail, and wherein tracking a location of the longitudinal rail using the remote sensing device includes locating the tracking device using the remote sensing device.

24. The method ofclaim 14 wherein the adjustable guidance fixture includes a base coupled to the instrument guide, said guidance fixture enabling a plurality of constrained adjustments of the instrument guide relative to the base.

25. The method ofclaim 23 wherein adjusting the orientation of the instrument guide includes using a first constrained motion of the constrained adjustments and then adjusting the guidance fixture using a second constrained motion of the constrained adjustments, so that the constrained trajectory of the instrument guide passes through the target.

26. The method ofclaim 25 wherein in adjusting the guidance fixture, the first of the constrained adjustments includes a rotation of the instrument guide about a central axis of the base, and the second of the constrained adjustments includes a pivoting of the instrument guide to adjust an angle of the instrument guide and the central axis.

27. The method ofclaim 14 further comprising:

providing a three-dimensional image of the spine;

computing a position of the constrained trajectory in the three-dimensional image based on the tracked location and orientation of the instrument guide;

displaying a planar section of the three-dimensional image of the body in conjunction with a representation of the constrained trajectory.

28. The method ofclaim 27 wherein the displayed planar section containing the target on the spine and the method further, and adjusting the orientation of the instrument guide includes:

adjusting the guidance fixture using a first constrained motion until the constrained trajectory of the instrument guide lies in a plane corresponding to the displayed planar section; and

adjusting the guidance fixture using a second constrained motion, such that the orientation continues to lie in the plane corresponding to the displayed planar section, until the constrained trajectory passes through the target point.

29. The method ofclaim 27 further comprising:

driving the surgical instrument along the constrained trajectory toward the target, including tracking a location of the surgical instrument and displaying the location of the surgical instrument in conjunction with the scanned image.