Percutaneous registration apparatus and method for use in computer-assisted surgical navigation

An apparatus and procedures for percutaneous placement of surgical implants and instruments such as, for example, screws, rods, wires and plates into various body parts using image guided surgery. The invention includes an apparatus for use with a surgical navigation system, an attaching device rigidly connected to a body part, such as the spinous process of a vertebrae, with an identification superstructure rigidly but removably connected to the attaching device. This identification superstructure, for example, is a reference arc and fiducial array which accomplishes the function of identifying the location of the superstructure, and, therefore, the body part to which it is fixed, during imaging by CAT scan or MRI, and later during medical procedures.

Skip to: Description  ·  Claims  ·  References Cited  · Patent History  ·  Patent History
Description

This application is a reissue of U.S. Pat. No. 6,226,548 issued on May 1, 2001 and also claims benefit under 35 U.S.C. §120 as a continuation of U.S. patent application Ser. No. 10/423,332 filed on Apr. 24, 2003, now RE 39,133; which is a reissue of U.S. Pat. No. 6,226,548 issued on May 1, 2001; which claims rights under 35 U.S.C. §119 on provisional application No. 60/059,915, filed on Sep. 24, 1997. Notice is also given that concurrently filed is U.S. patent application Ser. No. 09/148,498 filed on Sep. 4, 1998; which is also is a reissue of U.S. Pat. No. 6,226,548 issued on May 1, 2001 and also claims benefit under 35 U.S.C. §120 as a continuation of U.S. patent application Ser. No. 10/423,332 filed on Apr. 24, 2003; which is a reissue of U.S. Pat. No. 6,226,548 issued on May 1, 2001; which claims rights under 35 U.S.C. §119 on provisional application No. 60/059,915, filed on Sep. 24, 1997. The disclosures of the above applications are incorporated herein by reference.

The present invention claims rights under 35 U.S.C. §119 on provisional application No. 60/059,915, filed on Sep. 24, 1997, and entitled “Percutaneous Registration Apparatus and Method for Use in Computer-Assisted Surgical Navigation.”

FIELD OF THE INVENTION

The present invention relates generally to guiding, directing, or navigating instruments or implants in a body percutaneously, in conjunction with systems that use and generate images during medical and surgical procedures, which images assist in executing the procedures and indicate the relative position of various body parts, surgical implants, and instruments. In particular the invention relates to apparatus and minimally invasive procedures for navigating instruments and providing surgical implants percutaneously in the spine, for example, to stabilize the spine, correct deformity, or enhance fusion in conjunction with a surgical navigation system for generating images during medical and surgical procedures.

BACKGROUND OF THE INVENTION

Typically, spinal surgical procedures used, for example, to provide stabilization, fusion, or to correct deformities, require large incisions and substantial exposure of the spinal areas to permit the placement of surgical implants such as, for example, various forms of screws or hooks linked by rods, wires, or plates into portions of the spine. This standard procedure is invasive and can result in trauma, blood loss, and post operative pain. Alternatively, fluoroscopes have been used to assist in placing screws beneath the skin. In this alternative procedure at least four incisions must be made in the patient's back for inserting rods or wires through previously inserted screws. However, this technique can be difficult in that fluoroscopes only provide two-dimensional images and require the surgeon to rotate the fluoroscope frequently in order to get a mental image of the anatomy in three dimensions. Fluoroscopes also generate radiation to which the patient and surgical staff may become over exposed over time. Additionally, the subcutaneous implants required for this procedure may irritate the patient. A lever arm effect can also occur with the screws that are not connected by the rods or wires at the spine. Fluoroscopic screw placement techniques have traditionally used rods or plates that are subcutaneous to connect screws from vertebra to vertebra. This is due in part to the fact that there is no fluoroscopic technique that has been designed which can always adequately place rods or plates at the submuscular region (or adjacent to the vertebrae). These subcutaneous rods or plates may not be well tolerated by the patient. They also may not provide the optimal mechanical support to the spine because the moment arm of the construct can be increased, thereby translating higher loads and stresses through the construct.

A number of different types of surgical navigation systems have been described that include indications of the positions of medical instruments and patient anatomy used in medical or surgical procedures. For example, U.S. Pat. No. 5,383,454 to Bucholz; PCT Application No. PCT/US94/04530 (Publication No. WO 94/24933) to Bucholz; and PCT Application No. PCT/US95/12894 (Publication No. WO 96/11624) to Bucholz et al., the entire disclosures of which are incorporated herein by reference, disclose systems for use during a medical or surgical procedure using scans generated by a scanner prior to the procedure. Surgical navigation systems typically include tracking means such as, for example, an LED array on the body part, LED emitters on the medical instruments, a digitizer to track the positions of the body part and the instruments, and a display for the position of an instrument used in a medical procedure relative to an image of a body part.

Bucholz et al. WO 96/11624 is of particular interest, in that it identifies special issues associated with surgical navigation in the spine, where there are multiple vertebral bodies that can move with respect to each other. Bucholz et al. describes a procedure for operating on the spine during an open process where, after imaging, the spinous process reference points may move with respect to each other. It also discloses a procedure for modifying and repositioning the image data set to match the actual position of the anatomical elements. When there is an opportunity for anatomical movement, such movement degrades the fidelity of the pre-procedural images in depicting the intra-procedural anatomy. Therefore, additional innovations are desirable to bring image guidance to the parts of the body experiencing anatomical movement.

Furthermore, spinal surgical procedures are typically highly invasive. There is, thus, a need for more minimally invasive techniques for performing these spinal procedures, such as biopsy, spinal fixation, endoscopy, spinal implant insertion, fusion, and insertion of drug delivery systems, by reducing incision size and amount. One such way is to use surgical navigation equipment to perform procedures percutaneously, that is beneath the skin. To do so by means of surgical navigation also requires apparatus that can indicate the position of the spinal elements, such as, for example the vertebrae, involved in the procedure relative to the instruments and implants being inserted beneath the patient's skin and into the patient's spine. Additionally, because the spinal elements naturally move relative to each other, the user requires the ability to reorient these spinal elements to align with earlier scanned images stored in the surgical navigation system computer, to assure the correct location of those elements relative to the instruments and implants being applied or inserted percutaneously.

In light of the foregoing, there is a need in the art for apparatus and minimally invasive procedures for percutaneous placement of surgical implants and instruments in the spine, reducing the size and amount of incisions and utilizing surgical navigation techniques.

SUMMARY OF THE INVENTION

Accordingly, the present invention is directed to apparatus and procedures for percutaneous placement of surgical implants and instruments such as, for example, screws, rods, wires and plates into various body parts using image guided surgery. More specifically, one object of the present invention is directed to apparatus and procedures for the percutaneous placement of surgical implants and instruments into various elements of the spine using image guided surgery.

To achieve these objects and other advantages and in accordance with the purpose of the invention, as embodied and broadly described herein, the invention includes an apparatus for use with a surgical navigation system and comprises an attaching device rigidly connected to a body part, such as the spinous process of a vertebrae, with an identification superstructure rigidly but removably connected to the attaching device. This identification superstructure is a reference arc and fiducial array, which accomplishes the function of identifying the location of the superstructure, and, therefore, the body part to which it is fixed, during imaging by CAT scan or MRI, and later during medical procedures.

In one aspect, the attaching device is a clamp with jaws and sharp teeth for biting into the spinous process.

In another aspect, the fixture is a screw, having a head, wherein the screw is implanted into the spinous process and a relatively rigid wire is attached to the head of the screw and also implanted into the spinous process at an angle to the axis of the screw to prevent the screw from rotating in either direction.

In another aspect, the superstructure includes a central post, and a fiducial array and a reference arc rigidly but removably attached to the central post. The fiducial array is composed of image-compatible materials, and includes fiducials for providing a reference point, indicating the position of the array, which are rigidly attached to the fiducial array, composed of, for example titanium or aluminum spheres. The reference arc includes emitters, such as, for example Light Emitting Diodes (“LEDs”), passive reflective spheres, or other tracking means such as acoustic, magnetic, electromagnetic, radiologic, or micropulsed radar, for indicating the location of the reference arc and, thus, the body part it is attached to, during medical procedures.

In addition, the invention further comprises a method for monitoring the location of an instrument, surgical implants and the various portions of the body, for example, vertebrae, to be operated on in a surgical navigation system comprising the steps of: attaching a fixture to the spinous process; attaching a superstructure including a fiducial array with fiducials and a reference arc to the fixture; scanning the patient using CT, MRI or some other three-dimensional method, with fiducial array rigidly fixed to patient to identify it on the scanned image; and thereafter, in an operating room, using image-guided technology, touching an image-guided surgical pointer or other instrument to one or more of the fiducials on the fiducial array to register the location of the spinal clement fixed to the array and emitting an audio, visual, radiologic, magnetic or other detectable signal from the reference arc to an instrument such as, for example, a digitizer or other position-sensing unit, to indicate changes in position of the spinal element during a surgical procedure, and performing a surgical or medical procedure percutaneously on the patient using instruments and implants localable relative to spinal elements in a known position in the surgical navigation system.

In another aspect, the method includes inserting screws or rigid wires in spinal elements in the area involved in the anticipated surgical procedure before scanning the patient, and after scanning the patient and bringing the patient to the operating area, touching an image-guided or tracked surgical pointer to these screws and wires attached to the vertebrae to positively register their location in the surgical navigation computer, and manipulating either the patient's spine or the image to align the actual position of the spinal elements with the scanned image.

In another aspect, the method includes percutaneously implanting screws into spinal elements, which screws are located using image guided surgical navigation techniques, and further manipulating the orientation of the screw heads percutaneously using a head-positioning probe containing an emitter, that can communicate to the surgical navigation computer the orientation of the screw heads and position them, by use of a specially designed head-positioning tool with an end portion that mates with the heads of the screws and can rotate those screw heads to receive a rod, wire, plate, or other connecting implant. If a rod is being inserted into the screw heads for example, the method further includes tracking the location and position of the rod, percutaneously using a rod inserter having one or more emitters communicating the location and orientation of the rod to the surgical navigation computer.

The objects of the invention are to provide a user, such as a surgeon, with the system and method to track an instrument and surgical implants used in conjunction with a surgical navigation system in such a manner to operate percutaneously on a patient's body parts, such as spinal vertebrae which can move relative to each other.

It is a further object of this invention to provide a system and method to simply and yet positively indicate to the user a change in position of body parts, such as spinal vertebrae segments, from that identified in a stored image scan, such as from an MRI or CAT scan, and provide a method to realign those body parts to correspond with a previously stored image or the image to correspond with the actual current position of the body parts.

It is a further object of this invention to provide a system or method for allowing a fiducial array or reference arc that is removable from a location rigidly fixed to a body part and replaceable back in that precise location.

It is another object of this invention to provide a system and method for positively generating a display of instruments and surgical implants, such as, for example screws and rods, placed percutaneously in a patient using image-guided surgical methods and techniques.

It is another object of this invention for a percutaneous reference array and fiducial array, as described in this appplication, to be used to register and track the position of the vertebrae for the purposes of targeting a radiation dose to a diseased portion of said vertebrae using a traditional radiosurgical technique.

Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in this description.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one embodiment of the invention and together with the description, serve to explain the principles of the invention.

FIG. 1 is a schematic diagram of one preferred embodiment of a superstructure for use in the current invention, including a reference arc, center post and fiducial array and rigid Kirschner wires (“K wires”) and screws placed in the spine for use with a surgical navigation system for percutaneous spinal surgical procedures.

FIG. 1A is an enlarged view of the superstructure depicted in FIG. 1 engaging a vertebra by a clamp and also K wires implanted in adjacent vertebrae in the superior and inferior positions of the spinous process.

FIG. 2 is a diagram of the preferred embodiment of a clamp fixture for rigid connection to the spinous process of a single vertebrae with an H-shaped fiducial array attached to a center post rigidly attached to the clamp and a mating connector at the tip of the post for mating with a reference array, and a reference array for use in the current invention.

FIG. 2A is a side view of FIG. 2 FIG. 2B is another side view of FIG. 2.

FIG. 2C is a top view of FIG. 2.

FIG. 2D is an exploded view of FIG. 2 without the reference arc.

FIG. 2E is an exploded view of the interface of the center post and clamp of FIG. 2.

FIG. 3 is a diagram of a W-Shaped fiducial array mounted to a central post with generally spherical fiducials attached to the array, for mounting to a single vertebrae.

FIG. 3A is a side view of FIG. 3.

FIG. 3B is another side view of FIG. 3.

FIG. 3C is a top view of FIG. 3.

FIG. 4 is a diagram of a reference arc and fiducial attached to a center post for use in the current invention in mounting to a single vertebrae.

FIG. 4A is a side view of FIG. 4.

FIG. 4B is a back view of FIG. 4.

FIG. 4C is a top view of FIG. 4.

FIG. 4D is an expanded view of FIG. 4.

FIG. 4E is an expanded side view of FIG. 4.

FIG. 4F is an expanded view of the array foot and shoe of FIG. 4E.

FIG. 5 is a diagram of an alternative embodiment of a fixture for use in the current invention using a cannulated screw for insertion into a vertebrae, with Kirschner wire mounted on a central post and including an alternate embodiment of a fiduciary array and reference arc combined on a single structure.

FIG. 6 is a side view of the screw and Kirschner wire fixture of FIG. 5 implanted in a spinous process of a vertebrae.

FIG. 7 is a diagram of a screw-head positioning probe and multiaxial screw for insertion into a single vertebrae.

FIG. 7A is a diagram of the screw of FIG. 7.

FIG. 8 is a diagram of a head positioning probe, multiaxial screw and spinal segment.

FIG. 9 is a diagram of a rod inserter with an LED.

FIG. 10 is a diagram of an alternative embodiment of the invention depicting a cannulated tube and attachment for holding a reference arc.

FIG. 11 is a diagram of the cannulated tube of FIG. 10 with a reference arc and screw for attachment to a spinal process.

FIG. 12 is a posterior view of spinal segment and implanted screws before alignment.

FIG. 13 is a posterior view of spinal segment and implanted screws after alignment.

 DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Reference will now be made in detail to the present preferred embodiment of the invention, an example of which is illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. The following example is intended to be purely exemplary of the invention.

As generally described in PCT/US95/12894, the entire disclosure of which is incorporated herein by reference, a typical surgical navigation system is shown in FIG. 1 adopted to be used in the present invention. A computer assisted image-guided surgery system, indicated generally at 10, generates an image for display on a monitor 106 representing the position of one or more body elements, such as spinal elements fixedly held in a stabilizing frame or device such as a spinal surgery frame 125 commonly used for spinal surgery. A reference arc 120 bearing tracking means or emitters, such as for example LED emitters 122, is mounted to the spinous process by a central post 150. The structures 20 and K wires 260 of FIG. 1 are depicted in more detail in FIG. 1A. The image 105 is generated from an image data set, usually generated preoperatively by a CAT scanner or by MRI for example, which image 105 has reference points for at least one body element, such as a spinal element or vertebrae. The reference points of the particular body element have a fixed spatial relation to the particular body element.

The system includes an apparatus such as a digitizer or other Position Sensing Unit (PSU), such as for example sensor array 110 on support 112 for identifying, during the procedure, the relative position of each of the reference points to be displayed by tracking the position of emitters 122 on arc 120. The system also includes a processor 114 such as a PC or other suitable workstation processor associated with controller 108 for modifying the image data set according to the identified relative position of each of the reference points during the procedure, as identified by digitizer 110. The processor 114 can then, for example, generate an image data set representing the position of the body elements during the procedure for display on monitor 106. A surgical instrument 130, such as a probe or drill or other tool, may be included in the system, which is positioned relative to a body part and similarly tracked by sensor array 110.

In summary, the general operation of a surgical navigating system is well known in the art and need not further be described here.

In accordance with the preferred embodiment of the present invention, with further reference to FIGS. 1 through 6, a registration device 20 is rigidly fixed to a spinal element by, for example, a device such as a bone clamp 30 depicted in FIG. 2. Alternatively, a screw retention device 40, such as the cannulated screw 42 depicted in FIG. 5, and described in more detail below, can be used.

With reference now to FIG. 2, bone clamp 30 is fixedly attached to the spinous process. The clamp 30 includes at least two blades (or jaws) 32 with tips or teeth 34, which are preferably sharp, for driving together and penetrating soft tissue or more dense bone for rigid fixation to the spinous process. The teeth 34 are also preferably sized to accommodate the bulb shape of the spinous process. The driving mechanism 40 is, for example, a screw driven into a sleeve 41 and is also preferably located such that it will be accessible in a percutaneous manner. Attached to the clamp 30 is a superstructure 20. The superstructure 20 includes a central post 150 which is relocatable, that is, it fixes to the clamp 30 in a rigid fashion, for example, as depicted in FIGS. 2D and 2E, by being inserted into a V-shaped wedge 44 orienting the post 150 front to back and providing a mating hole 48 along the wedge 44 for insertion of post 150 in a single orientation and also providing fasteners such as screw 43 for lightning to lock the post 150 in place. The post 150 can be removed and reapplied by loosening and tightening screw 43, such that the original geometry and orientation is maintained. The central post 150 has at its apex a connector 60 with unique geometrical configuration, such as, for example, a starburst, onto which a spinal reference arc 120 of the superstructure 20 attaches. Any such standard reference arc 120 can be used, such as depicted in FIGS. 1A, 4, and 11, preferably including emitters 122, such as for example LEDs or reflective spheres for providing a positive indication of movement to the surgical navigation system during a procedure.

Also rigidly attached to the central post 150, as part of the superstructure 20 preferably at a location closer to the skin, or possibly collocated with or also performing the function of the reference arc 120, is a fiducial array 170, which can be of various different shapes, such as, for example the H-shaped frame 170 depicted in FIG. 2, the W-shaped frame 170′ as depicted in FIG. 3, the U-shaped frame 170″ as depicted in FIG. 4 or the X-shaped frame 120′, 170′″ depicted in FIG. 5 (depicting a structure that is both a fiducial array and a reference arc). As depicted in FIGS. 2 and 3, this array can include fiducial points 29 or spheres 17, rigidly attached to fiducial array 170, 170′ and is, for example, as depicted in FIG. 3, substantially in the shape of spheres 17 and of a material detectable by the CAT scan or MRI, preferably titanium or aluminum. This fiducial array such as 170 indicates to the surgical navigation system the location of the bone structure to which the clamp 30 and central post 150 are attached by touching a pointed surgical tracker to fiducial points 29 or a cup-shaped probe to fiducial spheres 17, thereby indicating the center of the fiducial to the surgical navigation controller 114. The array 170 and central post 150 are also attached to the clamp 30, as described above, in such a way that they can be removed and replaced in the same geometric orientation and location, for example, by means of a uniquely shaped interface, for example, a triangle, or a single unique shape or a combination of unique angles or pins with the clamp 30 such that the post 150 can only be reinserted the same way it was removed.

Additionally, the fiducial array 170, can be located at various heights on the post 150 to accomodate variations in patient tissue depth and size, preferably as close to the patient's body as possible, and then fixed at that specific height by the use of pins or indents matched to boles 19 (shown in FIG. 2) in the central post 150 or by placing the rods 39 of H-shaped array 170 in different holes 31. The fiducial array 170 also has, for example, divots 29 (shown in FIG. 2) shaped to interface with an instrument such as a surgical pointer 130 which can touch that divot 29 to register the location of the divot 29 and, thus, the location of the fiducial array 170 and likewise the spinal element in the surgical navigation system. Multiple divots can be registered to further increase accuracy of the registration system. In one preferred embodiment of the array, the fiducials 17 or 29 can be mounted in a manner such that they can be adjusted, for example by mounting them on a rotatable or collapsible arm 66 (as depicted in FIG. 3) that pivots and folds together, to get the maximum distance between fiducials while not dramatically increasing the field of view required at the time of scanning.

Alternatively, rather than using clamp 30, a screw 42 and rigid wire 45 attachment, as depicted in FIGS. 5 and 6, may be used to rigidly attach the central post of the superstructure 20 to a body element, such as, for example, a vertebrae. As depicted in FIG. 6, screw 42 is screwed into the spinal process of spinal element 100. A rigid wire 45, post, or other sufficiently rigid fastener such as for example a Kirschner wire (K-wire), is inserted through the cannulation in the center of post 150 and the screw 42 or is otherwise fixed to the screw 42, and exits the tip of the screw 42 at some angle, and is also implanted into the spinal element 100 to prevent the screw 42 from rotating in either direction.

Another embodiment for preventing the superstructure 20 from rotating as depicted in FIGS. 10 and 11 includes the insertion of a screw 85 through a cannulated tube 86 which has teeth 89 in the end (or V-shaped end) that would bite into the tip of the spinous process, preventing rotation.

Having described the preferred embodiment of this apparatus of the present system, the method of using this apparatus to practice the invention of registering a single vertebrae will now be discussed. The operation of a surgical navigating system is generally well known and is described in PCT/US95/12894. In the preferred method of operation, clamp 30 of FIG. 2 or screw 42 and K-Wire 45 of FIG. 5 are implanted percutaneously through a small incision in the skin and rigidly attached to the spinal process. This attachment occurs with the clamp 30, by driving the blades 32 of the clamp 30 together to hold the spinous process rigidly. The central post 150 is then rigidly fixed to the clamp 30 or screw 42 and the fiducial array 170 is rigidly fixed to the central post 150. The patient is then scanned and imaged with a CAT scan or MRI with a field of view sufficiently large to display the spinal anatomy and the clamp 30 or screw 42 and the fiducial array 170. This scan is loaded into the surgical navigation system processor 104.

After scanning the patient, the array 120 and post 150 can be removed from the patient, while leaving in place the rigidly connected clamp 30 or screw 42. For example, as depicted in FIGS. 4D and 4E, a foot 55 located below array 170″ engages with shoe 56 and rigidly connected by screws 57 and 58. Before the surgical procedure, the post 150, array 120 and other remaining portions of the superstructure 20, once removed, may be sterilized. The patient is then moved to the operating room or similar facility from, for example, the scanning room.

Once in the operating room, the patient may be positioned in an apparatus, such as, for example, a spinal surgery frame 125 to help keep the spinal elements in a particular position and relatively motionless. The superstructure 20 is then replaced on the clamp 30 or screw 42 in a precise manner to the same relative position to the spinal elements as it was in the earlier CAT scan or MRI imaging. The reference arc 120 is fixed to the starburst or other interface connector 60 on the central post 150 which is fixed to the clamp 30 or screw 42. The operator, for example a surgeon, then touches an instrument with a tracking emitter such as a surgical pointer 130 with emitters 195 to the divots 29 on the fiducial array 170 to register the location of the array 170 and, thus, because the spinal process is fixed to the fiducial array 170, the location of the spinal element is also registered in the surgical navigation system.

Once the superstructure 20 is placed back on the patient, any instrument 130 fitted with tracking emitters thereon such as, for example, a drill or screw driver, can be tracked in space relative to the spine in the surgical navigation system without further surgical exposure of the spine. The position of the instrument 130 is determined by the user stepping on a foot pedal 116 to begin tracking the emitter array 190. The emitters 195 generate infrared signals to be picked up by camera digitizer array 110 and triangulated to determine the position of the instrument 130. Additionally, other methods may be employed to track reference arcs, pointer probes, and other tracked instruments, such as with reflective spheres, or sound or magnetic emitters, instead of LED's. For example, reflective spheres can reflect infrared light that is emitted from the camera array 110 back to the camera array 110. The relative position of the body part, such as the spinal process is determined in a similar manner, through the use of similar emitters 122 mounted on the reference frame 120 in mechanical communication with the spinal segment. As is well known in this art and described generally in PCT/US95/12894, based upon the relative position of the spinal segment and the instrument 130 (such as by touching a known reference point) the computer would illustrate a preoperative scan—such as the proper CAT scan slice—on the screen of monitor 106 which would indicate the position of the tool 130 and the spinal segment for the area of the spine involved in the medical procedure.

For better access by the operator of various areas near the central post 150, the fiducial array 170 can be removed from the central post 150, by, for example, loosening screw 42 and sliding the array 170 off post 150, leaving the reference arc 120 in place or replacing it after removal of array 170. By leaving the reference arc 120 in place, the registration of the location of the spinal process is maintained. Additionally, the central post 150, reference arc 120, and fiducial array 170 can be removed after the spinal element has been registered leaving only the clamp 30 or screw 42 in place. The entire surgical field can then be sterilized and a sterile post 150 and reference arc 170 fixed to the clamp 30 or screw 42 with the registration maintained.

This surgical navigation system, with spinal element registration maintained, can then be used, for example, to place necessary and desired screws, rods, hooks, plates, wires, and other surgical instruments and implants percutaneously, using image-guided technology. Once the location of the spinal element 100 involved in the procedure is registered, by the process described above, in relation to the image data set and image 105 projected on monitor 106, other instruments 130 and surgical implants can be placed under the patient's skin at locations indicated by the instrument 130 relative to the spinal element 100.

Additionally, the location of other spinal elements, relative to the spinal element 100 containing the fiducial array 170, can be registered in the surgical navigation system by, for example, inserting additional screws 250, rigid wires 260, or other rigid implants or imageable devices into the spinal segment.

For example, as depicted in FIG. 1, and in more detail FIG. 1A, additional screws 250 or rigid and pointed wires 260 are placed in the vertebrae adjacent to the vertebrae containing the clamp 30 and post 150 prior to scanning. On the image 105 provided by monitor 106, the surgeon can see the clamp 30 or screw 42 and fiducial array 170 and also the additional screws 250, wires 260 or other imageable devices. When screws 250 or other devices are used, these screws 250 (as depicted in FIG. 7) may contain a divot 256 or other specially shaped interface on the head 255 so that a pointer probe 130 can be used to point to the head 255 of the screw 250 (or wire) and indicate the orientation of the screw 250 or wire 260 to the surgical navigation system by communicating to the controller 114 or by emission from LEDs 195 on probe 130 to digitizer 110. The image of these additional screws 250 also appear in the scan. Once the patient is then moved to the operating facility, rather than the scanning area, the image of the screw 250 can be compared to the actual position of the screw 250 as indicated by the pointer probe 130 that is touched to the head 255 of the screw 250 or wire 260. If necessary, the operator can manipulate the position of the patient to move the spinal element and thus the location of the screw 250 or wire 260 to realign the spinal elements with the earlier image of the spine. Alternatively, the operator can manipulate the image to correspond to the current position of the spinal segments.

For additional positioning information, the operator can place additional rigid wires 260 or screws 250 into the vertebrae, for example, located at the superior (toward the patient's head) and inferior (towards the patient's feet) ends of the spinal process to more accurately position those vertebrae relative to the other vertebrae and the image data. Additionally, the wires 260 and screws 250 implanted to provide positioning information can also be equipped with emitters, such as, for example, LEDs, to provide additional information to the surgical navigation system on the location of the wire 260 or screw 250, and thus the vertebra to which they are affixed.

Alternatively, the patient can be placed in a position stabilizing device, such as a spinal surgery frame 125 or board, before a scan is taken, and then moved to the operating facility for the procedure, maintaining the spine segments in the same position from the time of scanning until the time of surgery. Alternatively, a fluoroscope can be used to reposition the spinal segments relative to the earlier image from the scan. An ultrasound probe can be used to take real-time images of the spinal segment which can be portrayed by monitor 106 overlayed or superimposed on image 105. Then the operator can manually manipulate the spinal elements and take additional images of these elements with the fluoroscope to, in an iterative fashion, align the spinal elements with the previously scanned image 105.

Alternatively, a clamp 30 or screw 42 and superstructure 20 can be rigidly fixed to each vertebra involved in the surgical or medical procedure to register the position of each vertebra as explained previously for a single vertebra:

After the spinal elements are registered in the spine, various medical and surgical procedures can be performed on that patient. For example, spinal implants, endoscopes, or biopsy probes can be passed into the spine and procedures such as, for example, spinal fusion, manipulation, or disc removal can be performed percutaneously and facilitated by the surgical navigation image-guiding system. Additionally, a radiation dose can be targeted to a specific region of the vertebrae.

One such procedure facilitated by the apparatus and methods described above is the percutaneous insertion of screws and rods, fixed to different vertebra in a spine to stabilize them. Once screws, for example multiaxial screws 250, (as depicted in FIG. 12, before manipulation) are implanted through small incisions they can be manipulated by a head-positioning probe 280. The final position of screws 250 and heads 255 are depicted in FIG. 13. This probe 280, as depicted in FIG. 7, includes a head 285 that mates in a geometrically unique fashion with the head 255 of the screw 250. An emitter, such as for example an LED array 380 on the probe 280, indicates the location and orientation of the screw head 255 to the computer 114 of the surgical navigation system by providing an optical signal received by digitizer 110. The screw head 255 can then be rotatably manipulated under the patient's skin by the head positioning probe 280 to be properly oriented for the receipt of a rod 360 inserted through the rotating head 255. The operator can then plan a path from the head 255 of each screw 250 to the other screws 250 to be connected. Then, with reference now to FIG. 9, an optically tracked rod inserter 245 also equipped with emitters, such as, for example LEDs 247, can be placed through another small incision to mate with and guide a rod 360 through the holes or slots in the screw heads 245, through and beneath various tissues of the patient, with the rod inserter 245, and, therefore, the rod 360, fixed to the inserter 245, being tracked in the surgical navigation system. The operator can also use the computer 114 to determine the required bending angles of the rod 360. For greater visualization, the geometry of the screws 250 could be loaded into the computer 114 and when the position and orientation of the head 255 is given to the computer 114 via the probe 280, the computer 114 could place this geometry onto the image data and three-dimensional model. The rod 360 geometry could also be loaded into the computer 114 and could be visible and shown in real time on monitor 106 as the operator is placing it in the screw heads 255.

In an alternative procedure, one or more plates and/or one or more wires may be inserted instead of one or more rods 360.

It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention and in construction of this surgical navigation system without departing from the scope or spirit of the invention. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only.

Claims

1. An apparatus for facilitating percutaneous placement of surgical instruments into the spine, adapted for use with a surgical navigation system employing an energy-detecting array in communication with a surgical navigation computer to track positions of instruments in three dimensional space relative to a known reference point, said apparatus comprising:

a connector adapted to be rigidly attached to a portion of the spine;
at least one central post connected to said connector;
a position identification structure rigidly and removably connected to said central post at a predetermined position on said central post and adapted to be reconnected at the same said predetermined position, said identification structure being further adapted to allow a patient to be scanned with the structure connected to the central post, said structure including an assembly for communicating positioning information with respect to said assembly to the energy detecting array and surgical navigation computer; and
a connector assembly for said reconnecting of said structure substantially to said predetermined position on said central post.

2. The apparatus of claim 1, wherein the connector is a clamp having teeth adapted for biting into a spinous process.

3. The apparatus of claim 1, wherein the connector includes an elongated fixture with a central axis and a threaded end adapted to be inserted into the spinous process and a substantially rigid wire connected to the fixture with the central axis of the wire adapted to be implanted into the spinous process at an angle to elongated fixture to prevent the fixture from rotating.

4. The apparatus of claim 1, wherein said assembly for communication positioning information is a substantially H-shaped frame.

5. The apparatus of claim 1, wherein said assembly for communicating positioning information is a substantially W-shaped frame.

6. The apparatus of claim 1, wherein said assembly for communicating positioning information is a substantially U-shaped frame.

7. The apparatus of claim 1, wherein said assembly for communicating positioning information is a substantially X-shaped frame.

8. The apparatus of claim 1, wherein said assembly for communicating positioning information comprises:

a fiducial array for registering the location of a spinal clement with rigidly connected fiducials; and
a reference arc for signaling the position of a spinal element, said arc further comprising rigidly connected emitters.

9. The apparatus of claim 1, wherein said reference point is on the spine.

10. A method for monitoring the location of an instrument, surgical implant and various portions of the body, to be operated on, using a surgical navigation system with a surgical navigation computer and a digitizer array for monitoring the location of instruments in three-dimensional space relative to a known reference point, said method comprising the steps of:

attaching a fixture having a central post to a portion of the spine;
removably attaching an identification structure including a fiducial array and a reference arc to said central post;
providing a scanned three-dimensional image of a patient including said fiducial array rigidly attached to said central post of said fixture, said fixture being rigidly attached to the patient to identify the position of said fixture and said fiducial array on the scanned image;
using an image-guided system, by touching an image guided surgical pointer to one or more fiducials on the fiducial array to register the location of a spinal element fixed to said array; and
emitting a signal from said reference arc to indicate changes in position of the spinal clement during a surgical procedure.

11. The method of claim 10, further comprising:

performing a surgical procedure percutaneously on a patient using an instrument and implant locatable relative to the spinal element and said structure in known positions identified in the surgical navigation system.

12. The method of claim 10, further comprising:

inserting a threaded fixture having a substantially rigid wire into a spinal element; and
touching an image guided pointer to said threaded fixture and wire to positively register the location of said fixture and wire in a surgical navigation computer.

13. The method of claim 10, further comprising:

implanting imageable devices into spinal elements to identify the location of the spinal elements in the surgical navigation computer.

14. The method of claim 10, further comprising:

implanting imageable devices into a plurality of spinal elements; and
manipulating the patient's spine by viewing the location of the implanted devices, as communicated to the surgical navigation computer by touching an instrument with a tracking emitter to said implanted imageable devices to align the actual position of the spinal elements with the previously scanned image.

15. The method of claim 10 further comprising:

percutaneously implanting screws into spinal elements; and
locating the position of said screws using image guided surgical navigation techniques.

16. The method of claim 15 further comprising:

manipulating the orientation of the screw heads percutaneously using a head-positioning probe for communicating location containing an emitter, said probe communicating to the surgical navigation computer the orientation of the screw heads; and
using a head positioning tool for manipulating implants having an end portion that mates with the heads of the screws and rotating the screws to receive a connecting implant.

17. The method of claim 16 further comprising:

tracking the location and position of the connecting implant by means of an instrument affixed to the implant having emitters capable of communicating orientation and location to the surgical navigation computer.

18. A system for use in performing the percutaneous placement of surgical implants and instruments into the spine using image guided surgery and a surgical navigation computer and energy detecting array, said system comprising:

means for attaching a fixture to a portion of the spine;
means for communicating position information to the surgical navigation computer and energy detecting array said means rigidly and removably connected to said means for attaching a fixture;
means for providing location information of said spinal portion to the surgical navigation system adapted to be connected to spinal elements;
means for indicating screw-head position said means electrically connected to the surgical navigation system and adapted to mate with the head of a screw implanted in one or more of said spinal elements.

19. The system of claim 18 further comprising:

an elongated implant adapted to be inserted into said implanted screws;
means for indicating the position of said elongated implant electrically connected to the surgical navigation system and adapted to mate with the elongated implant.

20. The system of claim 18, wherein said implanted screws have heads and the elongated implant is a rod adapted to be guided through holes in said implanted screw heads.

21. An implant system for facilitating percutaneous placement of an implant in an anatomy and adapted for use with a surgical navigation system to track positions of the implant system in space, said implant system comprising:

an implant inserter adapted to releasably attach to the implant; and
a position identification structure rigidly and removably attached to said implant inserter;
wherein said position identification structure includes an assembly for providing position information to the surgical navigation system.

22. The implant system of claim 21 wherein said position identification structure includes at least one optical emitter.

23. The implant system of claim 21 wherein said position identification structure includes at least one light emitting diode.

24. The implant system of claim 21, wherein said position identification structure includes a selected geometrical shape.

25. The implant system of claim 21, wherein said position identification structure includes at least one of reflective spheres, acoustic emitters, magnets, eletromagnets, light emitting diodes, or combinations thereof.

26. The implant system of claim 25, wherein said reflectors can reflect at least one of visible light, infrared light, or combinations thereof.

27. The implant system of claim 25, wherein said magnets or electromagnets are operable to produce a magnetic field.

28. The implant system of claim 21, further comprising:

a rod;
wherein said rod can form a portion of the surgical implant.

29. The implant system of claim 28, wherein said rod extends between a first end and a second end;

wherein said implant inserter is releasably attached to at least one of said first end, said second end, or combinations thereof.

30. The implant system of claim 28, wherein said rod holder is operable to assist in moving a rod along a selected path.

31. The implant system of claim 28, wherein said rod holder is operably interconnected with the implant to determine a position of at least a portion of the implant.

32. The implant system of claim 31, wherein the implant includes

a screw head and a rod;
wherein said position identification structure attached to said rod holder is operable to determine a position of the rod relative to the screw head.

33. The implant system of claim 21, wherein said implant inserter includes a rod holder.

34. The implant system of claim 21, further comprising:

a bone screw;
wherein said bone screw can form a portion of the implant.

35. The implant system of claim 34, wherein said bone screw includes a slot operable to be aligned.

36. The implant system of claim 35, further comprising:

a second screw having a slot operable to be aligned percutaneously with said bone screw.

37. The implant system of claim 21, further comprising:

an imaging system operable to produce image data of the anatomy.

38. The implant system of claim 37, further comprising:

a display;
wherein the position of the implant inserter, the position of the implant, or combinations thereof can be displayed on the display with the image data.

39. The implant system of claim 38, further comprising:

a bone screw operable to be positioned in the anatomy;
wherein the geometry of the bone screw can be displayed on said display relative to the image data.

40. The implant system of claim 39, wherein the position of the implant, the geometry of the screw, and combinations thereof can be used intra-operably to determine bending of a rod.

41. The implant system of claim 38, wherein the display allows for substantially percutaneous placements of the implant relative to the anatomy.

42. The implant system of claim 21, further comprising:

an optical tracking system; an acoustic tracking system; an electromagnetic tracking system; a micropulsed radar tracking system; acoustic tracking system; or combinations thereof.

43. An implant system for facilitating percutaneous placement of an implant in an anatomy and adapted use with a surgical navigation system to track positions in space, said implant system comprising:

an implant inserter operably interconnected to the implant;
a position identification structure operably interconnected with said implant inserter;
wherein said position identification structure is trackable by the surgical navigation system having a position sensing unit to determine a position of at least one of said implant inserter, said implant, said reference structure, or combinations thereof.

44. The implant system of claim 43, further comprising:

a rod;
wherein said rod can form a portion of the implant;
wherein said rod extends between a first end and a second end.

45. The implant system of claim 44, wherein said implant inserter is operable to be interconnected with at least one of said first end, said second end, or combinations thereof.

46. The implant system of claim 44, wherein said implant inserter is operable to assist in moving said rod along a selected path.

47. The implant system of claim 46, further comprising:

a bone screw;
wherein said bone screw can form a portion of the implant.

48. The implant system of claim 47, wherein the surgical navigation system assists in displaying a position of said rod relative to said bone screw to intra-operatively determine a configuration of said rod.

49. The implant system of claim 67, wherein said position data displayed on the display is determined with a processor.

50. The implant system of claim 65, further comprising:

a rod implant;
a rod implant inserter;
a rod inserter reference structure operably interconnected with said rod inserter, wherein said rod inserter reference structure is operable with the surgical navigation system to determine a position of at least a portion of said rod implant;
wherein said implant inserter is operable to position said head relative to the anatomy percutaneously;
wherein said rod inserter is operable to position said rod implant relative to said head that has been positioned with said implant inserter.

51. The implant system of claim 43, wherein said position identification structure includes a selected geometrical shape.

52. The implant system of claim 43, wherein said position identification structure includes at least one of reflective spheres, acoustic emitters, magnets, electromagnets, emitting members, or combinations thereof.

53. The implant system of claim 52, wherein said emitting members include light emitting diodes.

54. The implant system of claim 52, wherein said reflectors can reflect at least one of visible light, infrared light, or combinations thereof.

55. The implant system of claim 43, further comprising:

an imaging system operable to produce image data of the anatomy.

56. The implant system of claim 55, further comprising:

a display;
wherein the position of the implant inserter, the position of the surgical implant, or combinations thereof can be displayed on the display with the image data.

57. The implant system of claim 56, further comprising:

a bone screw operable to be positioned in the anatomy;
wherein the geometry of the bone screw can be displayed on said display relative to the image data.

58. The implant system of claim 57, wherein the position of the implant, the geometry of the screw, and combinations thereof can be used intra-operatively to determine bending of a rod.

59. The implant system of claim 56, wherein the display allows for substantially percutaneous placements of the implant relative to the anatomy.

60. The implant system of claim 59, wherein said implant is a screw.

61. The implant system of claim 43, wherein said reference structure is removably connected to said implant inserter.

62. The implant system of claim 43, further comprising:

an optical tracking system; an acoustic tracking system; an electromagnetic tracking system; a micropulsed radar tracking system; acoustic tracking system; or combinations thereof.

63. An implant system for facilitating percutaneous placement of an implant in an anatomy that can be used with a surgical navigation system to track positions in space, the implant system comprising:

an implant having a head and a body operable to be positioned relative to a selected portion of the anatomy;
an implant inserter operable to be interconnected to said head of said implant; and
a reference structure operable to be interconnected with said implant inserter;
wherein said reference structure is operable with the surgical navigation system having a position sensing unit to identify relative positions of reference points to be displayed at the reference structure to determine a position and produce position data of at least one of said implant inserter, said implant, said reference structure, or combinations thereof;
wherein said implant inserter is operable to move said implant relative to the anatomy.

64. The implant system of claim 63, wherein said implant includes a screw and said body includes a thread operable to engage the anatomy;

wherein said implant inserter is operable to interconnect with at least the head of said screw.

65. The implant system of claim 63, further comprising:

an imaging device that produces image data of the anatomy.

66. The implant system of claim 65, further comprising:

a display;
wherein said display is operable to display the image data of the anatomy.

67. The implant system of claim 66, wherein the position data of said implant is determined by determining a position of the reference structure relative to the anatomy;

wherein said implant position data is displayed on the display relative to the image data of the anatomy.

68. The implant system of claim 67, wherein said implant position data includes a position of said head.

69. The implant system of claim 47, wherein said head includes a slot.

70. The implant system of claim 69, wherein said implant position data includes a position of said slot.

71. The implant system of claim 63, wherein said implant is operable to be positioned percutaneously relative to the anatomy via said implant inserter;

wherein said implant is operable to be manipulated percutaneously via said implant inserter and said referenced structure.

72. The implant system of claim 71, wherein the position image data of the implant is displayed on a display relative to image data of the anatomy to facilitate percutaneous placement of the implant relative to the anatomy.

73. The implant system of claim 72, wherein positioning of the implants includes positioning a head of a bone screw in a selected orientation relative to the anatomy.

Referenced Cited
U.S. Patent Documents
1576781 March 1926 Phillips
1735726 November 1929 Bornhardt
2407845 September 1946 Nemeyer
2650588 September 1953 Drew
2697433 December 1954 Sehnder
3016899 January 1962 Stenvall
3017887 January 1962 Heyer
3061936 November 1962 Dobbeleer
3073310 January 1963 Mocarski
3109588 November 1963 Polhemus et al.
3294083 December 1966 Alderson
3367326 February 1968 Frazier
3439256 April 1969 Kähne et al.
3577160 May 1971 White
3614950 October 1971 Rabey
3644825 February 1972 Davis, Jr. et al.
3674014 July 1972 Tillander
3702935 November 1972 Carey et al.
3704707 December 1972 Halloran
3821469 June 1974 Whetstone et al.
3868565 February 1975 Kuipers
3941127 March 2, 1976 Froning
3983474 September 28, 1976 Kuipers
4017858 April 12, 1977 Kuipers
4037592 July 26, 1977 Kronner
4052620 October 4, 1977 Brunnett
4054881 October 18, 1977 Raab
4058114 November 15, 1977 Soldner
4117337 September 26, 1978 Staats
4173228 November 6, 1979 Van Steenwyk et al.
4182312 January 8, 1980 Mushabac
4202349 May 13, 1980 Jones
4209254 June 24, 1980 Reymond et al.
4228799 October 21, 1980 Anichkov et al.
4256112 March 17, 1981 Kopf et al.
4259725 March 31, 1981 Andrews et al.
4262306 April 14, 1981 Renner
4287809 September 8, 1981 Egli et al.
4298874 November 3, 1981 Kuipers
4314251 February 2, 1982 Raab
4317078 February 23, 1982 Weed et al.
4319136 March 9, 1982 Jinkins
4328548 May 4, 1982 Crow et al.
4328813 May 11, 1982 Ray
4339953 July 20, 1982 Iwasaki
4341220 July 27, 1982 Perry
4346384 August 24, 1982 Raab
4358856 November 9, 1982 Stivender et al.
4368536 January 11, 1983 Pfeiler
4396885 August 2, 1983 Constant
4396945 August 2, 1983 DiMatteo et al.
4398540 August 16, 1983 Takemura et al.
4403321 September 6, 1983 Kruger
4418422 November 29, 1983 Richter et al.
4419012 December 6, 1983 Stephenson et al.
4422041 December 20, 1983 Lienau
4431005 February 14, 1984 McCormick
4457311 July 3, 1984 Sorenson et al.
4485815 December 4, 1984 Amplatz
4506676 March 26, 1985 Duska
4543959 October 1, 1985 Sepponen
4548208 October 22, 1985 Niemi
4571834 February 25, 1986 Fraser et al.
4572198 February 25, 1986 Codrington
4583538 April 22, 1986 Onik et al.
4584577 April 22, 1986 Temple
4592352 June 3, 1986 Patil
4602622 July 29, 1986 Bar et al.
4608977 September 2, 1986 Brown
4613866 September 23, 1986 Blood
4617925 October 21, 1986 Laitinen
4618978 October 21, 1986 Cosman
4621628 November 11, 1986 Bludermann
4625718 December 2, 1986 Olerud et al.
4638798 January 27, 1987 Shelden et al.
4642786 February 10, 1987 Hansen
4645343 February 24, 1987 Stockdale et al.
4649504 March 10, 1987 Krouglicof et al.
4651732 March 24, 1987 Frederick
4653509 March 31, 1987 Oloff et al.
4659971 April 21, 1987 Suzuki et al.
4660970 April 28, 1987 Ferrano
4673352 June 16, 1987 Hansen
4686997 August 18, 1987 Oloff et al.
4688037 August 18, 1987 Krieg
4701049 October 20, 1987 Beckman et al.
4705395 November 10, 1987 Hageniers
4705401 November 10, 1987 Addleman et al.
4706665 November 17, 1987 Gouda
4709156 November 24, 1987 Murphy et al.
4710708 December 1, 1987 Rorden et al.
4719419 January 12, 1988 Dawley
4722056 January 26, 1988 Roberts et al.
4722336 February 2, 1988 Kim et al.
4723544 February 9, 1988 Moore et al.
4727565 February 23, 1988 Ericson
RE32619 March 8, 1988 Damadian
4733661 March 29, 1988 Palestrant
4733969 March 29, 1988 Case et al.
4737032 April 12, 1988 Addleman et al.
4737794 April 12, 1988 Jones
4737921 April 12, 1988 Goldwasser et al.
4742356 May 3, 1988 Kuipers
4742815 May 10, 1988 Ninan et al.
4743770 May 10, 1988 Lee
4743771 May 10, 1988 Sacks et al.
4745290 May 17, 1988 Frankel et al.
4750487 June 14, 1988 Zanetti
4753528 June 28, 1988 Hines et al.
4760851 August 2, 1988 Fraser et al.
4761072 August 2, 1988 Pryor
4764016 August 16, 1988 Johansson
4771787 September 20, 1988 Wurster et al.
4779212 October 18, 1988 Levy
4782239 November 1, 1988 Hirose et al.
4788481 November 29, 1988 Niwa
4791934 December 20, 1988 Brunnett
4793355 December 27, 1988 Crum et al.
4794262 December 27, 1988 Sato et al.
4797907 January 10, 1989 Anderton
4803976 February 14, 1989 Frigg et al.
4804261 February 14, 1989 Kirschen
4805615 February 21, 1989 Carol
4809694 March 7, 1989 Ferrara
4821200 April 11, 1989 Oberg
4821206 April 11, 1989 Arora
4821731 April 18, 1989 Martinelli et al.
4822163 April 18, 1989 Schmidt
4825091 April 25, 1989 Breyer et al.
4829373 May 9, 1989 Leberl et al.
4836778 June 6, 1989 Baumrind et al.
4838265 June 13, 1989 Cosman et al.
4841967 June 27, 1989 Chang et al.
4845771 July 4, 1989 Wislocki et al.
4849692 July 18, 1989 Blood
4860331 August 22, 1989 Williams et al.
4862893 September 5, 1989 Martinelli
4869247 September 26, 1989 Howard, III et al.
4875165 October 17, 1989 Fencil et al.
4875478 October 24, 1989 Chen
4884566 December 5, 1989 Mountz et al.
4889526 December 26, 1989 Rauscher et al.
4896673 January 30, 1990 Rose et al.
4905698 March 6, 1990 Strohl, Jr. et al.
4923459 May 8, 1990 Nambu
4931056 June 5, 1990 Ghajar et al.
4943296 July 24, 1990 Funakubo et al.
4945305 July 31, 1990 Blood
4945914 August 7, 1990 Allen
4951653 August 28, 1990 Fry et al.
4955891 September 11, 1990 Carol
4961422 October 9, 1990 Marchosky et al.
4971069 November 20, 1990 Gracovetsky
4977655 December 18, 1990 Martinelli
4989608 February 5, 1991 Ratner
4991579 February 12, 1991 Allen
5002058 March 26, 1991 Martinelli
5005592 April 9, 1991 Cartmell
5013317 May 7, 1991 Cole et al.
5016639 May 21, 1991 Allen
5017139 May 21, 1991 Mushabac
5027818 July 2, 1991 Bova et al.
5030196 July 9, 1991 Inoue
5030222 July 9, 1991 Calandruccio et al.
5031203 July 9, 1991 Trecha
5042486 August 27, 1991 Pfeiler et al.
5047036 September 10, 1991 Koutrouvelis
5050608 September 24, 1991 Watanabe et al.
5054492 October 8, 1991 Scribner et al.
5057095 October 15, 1991 Fabian
5059789 October 22, 1991 Salcudean
5078140 January 7, 1992 Kwoh
5079699 January 7, 1992 Tuy et al.
5080662 January 14, 1992 Paul
5086401 February 4, 1992 Glassman et al.
5094241 March 10, 1992 Allen
5097839 March 24, 1992 Allen
5098426 March 24, 1992 Sklar et al.
5099845 March 31, 1992 Besz et al.
5099846 March 31, 1992 Hardy
5105829 April 21, 1992 Fabian et al.
5107839 April 28, 1992 Houdek et al.
5107843 April 28, 1992 Aarnio et al.
5107862 April 28, 1992 Fabian et al.
5109194 April 28, 1992 Cantaloube
5119817 June 9, 1992 Allen
5142930 September 1, 1992 Allen et al.
5143076 September 1, 1992 Hardy et al.
5152288 October 6, 1992 Hoenig et al.
5160337 November 3, 1992 Cosman
5161536 November 10, 1992 Vilkomerson et al.
5178164 January 12, 1993 Allen
5178621 January 12, 1993 Cook et al.
5186174 February 16, 1993 Schlondorff et al.
5187475 February 16, 1993 Wagener et al.
5188126 February 23, 1993 Fabian et al.
5190059 March 2, 1993 Fabian et al.
5193106 March 9, 1993 DeSena
5197476 March 30, 1993 Nowacki et al.
5197965 March 30, 1993 Cherry et al.
5198768 March 30, 1993 Keren
5198877 March 30, 1993 Schulz
5207688 May 4, 1993 Carol
5211164 May 18, 1993 Allen
5211165 May 18, 1993 Dumoulin et al.
5211176 May 18, 1993 Ishiguro et al.
5212720 May 18, 1993 Landi et al.
5214615 May 25, 1993 Bauer
5219351 June 15, 1993 Teubner et al.
5222499 June 29, 1993 Allen et al.
5224049 June 29, 1993 Mushabac
5228442 July 20, 1993 Imran
5230338 July 27, 1993 Allen et al.
5230623 July 27, 1993 Guthrie et al.
5233990 August 10, 1993 Barnea
5237996 August 24, 1993 Waldman et al.
5249581 October 5, 1993 Horbal et al.
5251127 October 5, 1993 Raab
5251635 October 12, 1993 Dumoulin et al.
5253647 October 19, 1993 Takahashi et al.
5255680 October 26, 1993 Darrow et al.
5257636 November 2, 1993 White
5257998 November 2, 1993 Ota et al.
5261404 November 16, 1993 Mick et al.
5265610 November 30, 1993 Darrow et al.
5265611 November 30, 1993 Hoenig et al.
5269759 December 14, 1993 Hernandez et al.
5271400 December 21, 1993 Dumoulin et al.
5273025 December 28, 1993 Sakiyama et al.
5274551 December 28, 1993 Corby, Jr.
5279309 January 18, 1994 Taylor et al.
5285787 February 15, 1994 Machida
5291199 March 1, 1994 Overman et al.
5291889 March 8, 1994 Kenet et al.
5295200 March 15, 1994 Boyer
5295483 March 22, 1994 Nowacki et al.
5297549 March 29, 1994 Beatty et al.
5299253 March 29, 1994 Wessels
5299254 March 29, 1994 Dancer et al.
5299288 March 29, 1994 Glassman et al.
5300080 April 5, 1994 Clayman et al.
5305091 April 19, 1994 Gelbart et al.
5305203 April 19, 1994 Raab
5306271 April 26, 1994 Zinreich et al.
5307072 April 26, 1994 Jones, Jr.
5309913 May 10, 1994 Kormos et al.
5315630 May 24, 1994 Sturm et al.
5316024 May 31, 1994 Hirschi et al.
5318025 June 7, 1994 Dumoulin et al.
5320111 June 14, 1994 Livingston
5325728 July 5, 1994 Zimmerman et al.
5325873 July 5, 1994 Hirschi et al.
5329944 July 19, 1994 Fabian et al.
5330485 July 19, 1994 Clayman et al.
5333168 July 26, 1994 Fernandes et al.
5353795 October 11, 1994 Souza et al.
5353800 October 11, 1994 Pohndorf et al.
5353807 October 11, 1994 DeMarco
5359417 October 25, 1994 Muller et al.
5368030 November 29, 1994 Zinreich et al.
5371778 December 6, 1994 Yanof et al.
5375596 December 27, 1994 Twiss et al.
5377678 January 3, 1995 Dumoulin et al.
5383454 January 24, 1995 Bucholz
5385146 January 31, 1995 Goldreyer
5385148 January 31, 1995 Lesh et al.
5386828 February 7, 1995 Owens et al.
5389101 February 14, 1995 Heilbrun et al.
5391199 February 21, 1995 Ben-Haim
5394457 February 28, 1995 Leibinger et al.
5394875 March 7, 1995 Lewis et al.
5397329 March 14, 1995 Allen
5398684 March 21, 1995 Hardy
5399146 March 21, 1995 Nowacki et al.
5400384 March 21, 1995 Fernandes et al.
5402801 April 4, 1995 Taylor
5408409 April 18, 1995 Glassman et al.
5413573 May 9, 1995 Koivukangas
5417210 May 23, 1995 Funda et al.
5419325 May 30, 1995 Dumoulin et al.
5423334 June 13, 1995 Jordan
5425367 June 20, 1995 Shapiro et al.
5425382 June 20, 1995 Golden et al.
5426683 June 20, 1995 O'Farrell, Jr. et al.
5426687 June 20, 1995 Goodall et al.
5427097 June 27, 1995 Depp
5429132 July 4, 1995 Guy et al.
5433198 July 18, 1995 Desai
RE35025 August 22, 1995 Anderton
5437277 August 1, 1995 Dumoulin et al.
5443066 August 22, 1995 Dumoulin et al.
5443489 August 22, 1995 Ben-Haim
5444756 August 22, 1995 Pai et al.
5445144 August 29, 1995 Wodicka et al.
5445150 August 29, 1995 Dumoulin et al.
5445166 August 29, 1995 Taylor
5446548 August 29, 1995 Gerig et al.
5447154 September 5, 1995 Cinquin et al.
5448610 September 5, 1995 Yamamoto et al.
5453686 September 26, 1995 Anderson
5456718 October 10, 1995 Szymaitis
5457641 October 10, 1995 Zimmer et al.
5458718 October 17, 1995 Venkitachalam
5464446 November 7, 1995 Dreessen et al.
5469847 November 28, 1995 Zinreich et al.
5478341 December 26, 1995 Cook et al.
5478343 December 26, 1995 Ritter
5480422 January 2, 1996 Ben-Haim
5480439 January 2, 1996 Bisek et al.
5483961 January 16, 1996 Kelly et al.
5484437 January 16, 1996 Michelson
5485849 January 23, 1996 Panescu et al.
5487391 January 30, 1996 Panescu
5487729 January 30, 1996 Avellanet et al.
5487757 January 30, 1996 Truckai et al.
5490196 February 6, 1996 Rudich et al.
5494034 February 27, 1996 Schlondorff et al.
5503416 April 2, 1996 Aoki et al.
5513637 May 7, 1996 Twiss et al.
5514146 May 7, 1996 Lam et al.
5515160 May 7, 1996 Schulz et al.
5517990 May 21, 1996 Kalfas et al.
5520660 May 28, 1996 Loos et al.
5526576 June 18, 1996 Fuch et al.
5531227 July 2, 1996 Schneider
5531520 July 2, 1996 Grimson et al.
5542938 August 6, 1996 Avellanet et al.
5543951 August 6, 1996 Moehrmann
5546940 August 20, 1996 Panescu et al.
5546949 August 20, 1996 Frazin et al.
5546951 August 20, 1996 Ben-Haim
5551429 September 3, 1996 Fitzpatrick et al.
5558091 September 24, 1996 Acker et al.
5566681 October 22, 1996 Manwaring et al.
5568384 October 22, 1996 Robb et al.
5568809 October 29, 1996 Ben-haim
5571109 November 5, 1996 Bertagnoli
5572999 November 12, 1996 Funda et al.
5573533 November 12, 1996 Strul
5575794 November 19, 1996 Walus et al.
5575798 November 19, 1996 Koutrouvelis
5583909 December 10, 1996 Hanover
5588430 December 31, 1996 Bova et al.
5590215 December 31, 1996 Allen
5592939 January 14, 1997 Martinelli
5595193 January 21, 1997 Walus et al.
5596228 January 21, 1997 Anderton et al.
5600330 February 4, 1997 Blood
5603318 February 18, 1997 Heilbrun et al.
5603328 February 18, 1997 Zucker et al.
5611025 March 11, 1997 Lorensen et al.
5617462 April 1, 1997 Spratt
5617857 April 8, 1997 Chader et al.
5619261 April 8, 1997 Anderton
5622169 April 22, 1997 Golden et al.
5622170 April 22, 1997 Schulz
5627873 May 6, 1997 Hanover et al.
5628315 May 13, 1997 Vilsmeier et al.
5630431 May 20, 1997 Taylor
5636644 June 10, 1997 Hart et al.
5638819 June 17, 1997 Manwaring et al.
5640170 June 17, 1997 Anderson
5642395 June 24, 1997 Anderton et al.
5643268 July 1, 1997 Vilsmeier et al.
5645065 July 8, 1997 Shapiro et al.
5646524 July 8, 1997 Gilboa
5647361 July 15, 1997 Damadian
5662111 September 2, 1997 Cosman
5664001 September 2, 1997 Tachibana et al.
5674296 October 7, 1997 Bryan et al.
5676673 October 14, 1997 Ferre et al.
5681260 October 28, 1997 Ueda et al.
5682886 November 4, 1997 Delp et al.
5682890 November 4, 1997 Kormos et al.
5690108 November 25, 1997 Chakeres
5694945 December 9, 1997 Ben-Haim
5695500 December 9, 1997 Taylor et al.
5695501 December 9, 1997 Carol et al.
5697377 December 16, 1997 Wittkampf
5702406 December 30, 1997 Vilsmeier et al.
5711299 January 27, 1998 Manwaring et al.
5713946 February 3, 1998 Ben-Haim
5715822 February 10, 1998 Watkins
5715836 February 10, 1998 Kliegis et al.
5718241 February 17, 1998 Ben-Haim et al.
5727552 March 17, 1998 Ryan
5727553 March 17, 1998 Saad
5729129 March 17, 1998 Acker
5730129 March 24, 1998 Darrow et al.
5730130 March 24, 1998 Fitzpatrick et al.
5732703 March 31, 1998 Kalfas et al.
5735278 April 7, 1998 Hoult et al.
5738096 April 14, 1998 Ben-Haim
5740802 April 21, 1998 Nafis et al.
5741214 April 21, 1998 Ouchi et al.
5742394 April 21, 1998 Hansen
5744953 April 28, 1998 Hansen
5748767 May 5, 1998 Raab
5749362 May 12, 1998 Funda et al.
5749835 May 12, 1998 Glantz
5752513 May 19, 1998 Acker et al.
5755725 May 26, 1998 Druais
RE35816 June 2, 1998 Schulz
5758667 June 2, 1998 Slettenmark
5762064 June 9, 1998 Polyani
5767669 June 16, 1998 Hansen et al.
5767699 June 16, 1998 Bosnyak et al.
5767960 June 16, 1998 Orman
5769789 June 23, 1998 Wang et al.
5769843 June 23, 1998 Abela et al.
5769861 June 23, 1998 Vilsmeier
5772594 June 30, 1998 Barrick
5772661 June 30, 1998 Michelson
5775322 July 7, 1998 Silverstein et al.
5776064 July 7, 1998 Kalfas et al.
5782765 July 21, 1998 Jonkman
5787886 August 4, 1998 Kelly et al.
5792055 August 11, 1998 McKinnon
5792147 August 11, 1998 Evans et al.
5795294 August 18, 1998 Luber et al.
5797849 August 25, 1998 Vesely et al.
5799055 August 25, 1998 Peshkin et al.
5799099 August 25, 1998 Wang et al.
5800352 September 1, 1998 Ferre et al.
5800535 September 1, 1998 Howard, III
5802719 September 8, 1998 O'Farrell, Jr. et al.
5803089 September 8, 1998 Ferre et al.
5807252 September 15, 1998 Hassfeld et al.
5810008 September 22, 1998 Dekel et al.
5810728 September 22, 1998 Kuhn
5810735 September 22, 1998 Halperin et al.
5820553 October 13, 1998 Hughes
5823192 October 20, 1998 Kalend et al.
5823958 October 20, 1998 Truppe
5828725 October 27, 1998 Levinson
5828770 October 27, 1998 Leis et al.
5829444 November 3, 1998 Ferre et al.
5831260 November 3, 1998 Hansen
5833608 November 10, 1998 Acker
5834759 November 10, 1998 Glossop
5836954 November 17, 1998 Heilbrun et al.
5840024 November 24, 1998 Taniguchi et al.
5840025 November 24, 1998 Ben-Haim
5843076 December 1, 1998 Webster, Jr. et al.
5848967 December 15, 1998 Cosman
5851183 December 22, 1998 Bucholz
5865846 February 2, 1999 Bryan et al.
5868674 February 9, 1999 Glowinski et al.
5868675 February 9, 1999 Henrion et al.
5871445 February 16, 1999 Bucholz
5871455 February 16, 1999 Ueno
5871487 February 16, 1999 Warner et al.
5873822 February 23, 1999 Ferre et al.
5882304 March 16, 1999 Ehnholm et al.
5884410 March 23, 1999 Prinz
5889834 March 30, 1999 Vilsmeier et al.
5891034 April 6, 1999 Bucholz
5891157 April 6, 1999 Day et al.
5904691 May 18, 1999 Barnett et al.
5907395 May 25, 1999 Schultz et al.
5913820 June 22, 1999 Bladen et al.
5920395 July 6, 1999 Schulz
5921992 July 13, 1999 Costales et al.
5923727 July 13, 1999 Navab
5928248 July 27, 1999 Acker
5938603 August 17, 1999 Ponzi
5938694 August 17, 1999 Jaraczewski et al.
5947980 September 7, 1999 Jensen et al.
5947981 September 7, 1999 Cosman
5950629 September 14, 1999 Taylor et al.
5951475 September 14, 1999 Gueziec et al.
5951571 September 14, 1999 Audette
5954647 September 21, 1999 Bova et al.
5957844 September 28, 1999 Dekel et al.
5964796 October 12, 1999 Imran
5967980 October 19, 1999 Ferre et al.
5967982 October 19, 1999 Barnett
5968047 October 19, 1999 Reed
5971997 October 26, 1999 Guthrie et al.
5976156 November 2, 1999 Taylor et al.
5980535 November 9, 1999 Barnett et al.
5983126 November 9, 1999 Wittkampf
5987349 November 16, 1999 Schulz
5987960 November 23, 1999 Messner et al.
5999837 December 7, 1999 Messner et al.
5999840 December 7, 1999 Grimson et al.
6001130 December 14, 1999 Bryan et al.
6006126 December 21, 1999 Cosman
6006127 December 21, 1999 Van Der Brug et al.
6013087 January 11, 2000 Adams et al.
6014580 January 11, 2000 Blume et al.
6016439 January 18, 2000 Acker
6019725 February 1, 2000 Vesely et al.
6024695 February 15, 2000 Taylor et al.
6050724 April 18, 2000 Schmitz et al.
6059718 May 9, 2000 Taniguchi et al.
6063022 May 16, 2000 Ben-Haim
6071288 June 6, 2000 Carol et al.
6073043 June 6, 2000 Schneider
6076008 June 13, 2000 Bucholz
6096050 August 1, 2000 Audette
6104944 August 15, 2000 Martinelli
6118845 September 12, 2000 Simon et al.
6122538 September 19, 2000 Sliwa, Jr. et al.
6122541 September 19, 2000 Cosman et al.
6131396 October 17, 2000 Duerr et al.
6139183 October 31, 2000 Graumann
6147480 November 14, 2000 Osadchy et al.
6149592 November 21, 2000 Yanof et al.
6156067 December 5, 2000 Bryan et al.
6161032 December 12, 2000 Acker
6165181 December 26, 2000 Heilbrun et al.
6167296 December 26, 2000 Shahidi
6172499 January 9, 2001 Ashe
6174330 January 16, 2001 Stinson
6175756 January 16, 2001 Ferre et al.
6178345 January 23, 2001 Vilsmeier et al.
6194639 February 27, 2001 Botella et al.
6201387 March 13, 2001 Govari
6203497 March 20, 2001 Dekel et al.
6211666 April 3, 2001 Acker
6223067 April 24, 2001 Vilsmeier
6233476 May 15, 2001 Strommer et al.
6236875 May 22, 2001 Bucholz et al.
6246231 June 12, 2001 Ashe
6259942 July 10, 2001 Westermann et al.
6273896 August 14, 2001 Franck et al.
6285902 September 4, 2001 Kienzle, III et al.
6298262 October 2, 2001 Franck et al.
6314310 November 6, 2001 Ben-Haim et al.
6332089 December 18, 2001 Acker et al.
6341231 January 22, 2002 Ferre et al.
6348058 February 19, 2002 Melkent et al.
6351659 February 26, 2002 Vilsmeier
6381485 April 30, 2002 Hunter et al.
6424856 July 23, 2002 Vilsmeier et al.
6427314 August 6, 2002 Acker
6428547 August 6, 2002 Vilsmeier et al.
6434415 August 13, 2002 Foley et al.
6437567 August 20, 2002 Schenck et al.
6445943 September 3, 2002 Ferre et al.
6470207 October 22, 2002 Simon et al.
6474341 November 5, 2002 Hunter et al.
6478802 November 12, 2002 Kienzle, III et al.
6484049 November 19, 2002 Seeley et al.
6490475 December 3, 2002 Seeley et al.
6493573 December 10, 2002 Martinelli et al.
6498944 December 24, 2002 Ben-Haim et al.
6499488 December 31, 2002 Hunter et al.
6516046 February 4, 2003 Fröhlich et al.
6527443 March 4, 2003 Vilsmeier et al.
6551325 April 22, 2003 Neubauer et al.
6584174 June 24, 2003 Schubert et al.
6609022 August 19, 2003 Vilsmeier et al.
6611700 August 26, 2003 Vilsmeier et al.
6640128 October 28, 2003 Vilsmeier et al.
6694162 February 17, 2004 Hartlep
6701179 March 2, 2004 Martinelli et al.
20010007918 July 12, 2001 Vilsmeier et al.
20020095081 July 18, 2002 Vilsmeier
20040024309 February 5, 2004 Ferre et al.
Foreign Patent Documents
964149 March 1975 CA
3042343 June 1982 DE
35 08730 March 1985 DE
37 17 871 May 1987 DE
38 38011 November 1988 DE
3831278 March 1989 DE
42 13 426 April 1992 DE
42 25 112 July 1992 DE
4233978 April 1994 DE
197 15 202 April 1997 DE
197 47 427 October 1997 DE
197 51 761 November 1997 DE
198 32 296 July 1998 DE
10085137 November 2002 DE
0018166 April 1980 EP
0 062 941 March 1982 EP
0 119 660 September 1984 EP
0 155 857 January 1985 EP
0319844 January 1988 EP
0359773 May 1988 EP
0 326 768 December 1988 EP
0419729 September 1989 EP
0350996 January 1990 EP
0651968 August 1990 EP
0 427 358 October 1990 EP
0501993 November 1990 EP
0 456 103 May 1991 EP
0581704 July 1993 EP
0655138 August 1993 EP
0894473 January 1995 EP
0469966 August 1995 EP
0 908 146 October 1998 EP
0 930 046 October 1998 EP
2417970 February 1979 FR
2 094 590 February 1982 GB
2 164 856 October 1984 GB
61-94639 October 1984 JP
62-327 June 1985 JP
63-240851 March 1987 JP
3-267054 March 1990 JP
2765738 June 1998 JP
2 618 211 July 1987 WO
WO 88/09151 December 1988 WO
WO 89/05123 June 1989 WO
WO 90/05494 November 1989 WO
WO 91/03982 April 1991 WO
WO 91/04711 April 1991 WO
WO 91/07726 May 1991 WO
WO 92/03090 March 1992 WO
WO 92/06645 April 1992 WO
WO 94/04938 March 1994 WO
WO 95/07055 September 1994 WO
WO 94/23647 October 1994 WO
WO 94/24933 November 1994 WO
WO 96/32059 November 1995 WO
WO 96/11624 April 1996 WO
WO 97/49453 June 1997 WO
WO 97/36192 October 1997 WO
WO 97/40764 November 1997 WO
WO 99/23956 November 1997 WO
WO 98/08554 March 1998 WO
WO 98/38908 September 1998 WO
WO 99/15097 September 1998 WO
WO 99/21498 October 1998 WO
WO 99/27839 December 1998 WO
WO 99/33406 December 1998 WO
WO 99/38449 January 1999 WO
WO 99/52094 April 1999 WO
WO 99/26549 June 1999 WO
WO 99/29253 June 1999 WO
WO 99/37208 July 1999 WO
WO 99/60939 December 1999 WO
WO 01/30437 May 2001 WO
Other references
  • Adams et al., Computer-Assisted Surgery, IEEE Computer Graphics & Applications, pp. 43-51, (May 1990).
  • Adams et al., “Orientation Aid for Head and Neck Surgeons,” Innov. Tech. Biol. Med., vol. 13, No. 4, 1992, pp. 409-424.
  • Barrick et al., “Prophylactic Intramedullary Fixation of the Tibia for Stress Fracture in a Professional Athlete,” Journal of Orthopaedic Trauma, vol. 6, No. 2, pp. 241-244 (1992).
  • Barrick et al., “Technical Difficulties with the Brooker-Wills Nail in Acute Fractures of the Femur,” Journal of Orthopaedic Trauma, vol. 4, No. 2, pp. 144-150 (1990).
  • Barrick et al., “Distal Locking Screw Insertion Using a Cannulated Drill Bit: Technical Note,” Journal of Orthopaedic Trauma, vol. 7, No. 3, 1993, pp. 248-251.
  • Batnitzky et al., “Three-Dimensional Computer Reconstructions of Brain Lesions from Surface Contours Provided by Computed Tomography: A Prospectus,” Neurosurgery, vol. 11, No. 1, Part 1, 1982, pp. 73-84.
  • Benzel et al., “Magnetic Source Imaging: a Review of the Magnes System of Biomagnetic Technologies Incorporated,” Neurosurgery, vol. 33, No. 2 (Aug. 1993), pp. 252-259.
  • Bergstrom et al. Stereotaxic Computed Tomography, Am. J. Roentgenol, vol. 127 pp. 167-170.
  • Bouazza-Marouf et al.; “Robotic-Assisted Internal Fixation of Femoral Fractures”, IMECHE., pp. 51-58 (1995).
  • Brack et al., “Accurate X-ray Based Navigation in Computer-Assisted Orthopedic Surgery,” CAR '98, pp. 716-722.
  • Brown, R., M.D., A Stereotactic Head Frame for Use with CT Body Scanners, Investigative Radiology© J.B. Lippincott Company, pp. 300-304 (Jul.-Aug. 1979).
  • Bryan, “Bryan Cervical Disc System Single Level Surgical Technique”, Spinal Dynamics, 2002, pp. 1-33.
  • Bucholz et al., “Variables affecting the accuracy of stereotactic localizationusing computerized tomography,” Journal of Neurosurgery, vol. 79, Nov. 1993, pp. 667-673.
  • Bucholz, R.D., et al. Image-guided surgical techniqes for infections and trauma of the central nervous system, Neurosurg. Clinics of N.A., vol. 7, No. 2, pp. 187-200 (1996).
  • Bucholz, R.D., et al., A Comparison of Sonic Digitizers Versus Light Emitting Diode-Based Localization, Interactive Image-Guided Neurosurgery, Chapter 16, pp. 179-200 (1993).
  • Bucholz, R.D., et al., Intraoperative localization using a three dimensional optical digitizer, SPIE—The Intl. Soc. for Opt. Eng., vol. 1894, pp. 312-322 (Jan. 17-19, 1993).
  • Bucholz, R.D., et al., Intraoperative Ultrasonic Brain Shift Monitor and Analysis, Stealth Station Marketing Brochure (2 pages) (undated).
  • Bucholz, R.D., et al., The Correction of Stereotactic Inaccuracy Caused by Brain Shift Using an Intraoperative Ultrasound Device, First Joint Conference, Computer Vision, Virtual Reality and Robotics in Medicine and Medical Robotics and Computer-Assisted Surgery, Grenoble, France, pp. 459-466 (Mar. 19-22, 1997).
  • Champleboux et al., “Accurate Calibration of Cameras and Range Imaging Sensors: the NPBS Method,” IEEE International Conference on Robotics and Automation, Nice, France, May, 1992.
  • Champleboux, “Utilisation de Fonctions Splines pour la Mise au Point D'un Capteur Tridimensionnel sans Contact,” Quelques Applications Medicales, Jul. 1991.
  • Cinquin et al., “Computer Assisted Medical Interventions,” IEEE Engineering in Medicine and Biology, May/Jun. 1995, pp. 254-263.
  • Cinquin et al., “Computer Assisted Medical Interventions,” International Advanced Robotics Programme, Sep. 1989, pp. 63-65.
  • Clarysse et al., “A Computer-Assisted System for 3-D Frameless Localization in Stereotaxic MRI,” IEEE Transactions on Medical Imaging, vol. 10, No. 4, Dec. 1991, pp. 523-529.
  • Cutting M.D. et al., Optical Tracking of Bone Fragments During Craniofacial Surgery, Second Annual International Symposium on Medical Robotics and Computer Assisted Surgery, pp. 221-225, (Nov. 1995).
  • Feldmar et al., “3D-2D Projective Registration of Free-Form Curves and Surfaces,” Rapport de recherche (Inria Sophia Antipolis), 1994, pp. 1-44.
  • Foley et al., “Fundamentals of Interactive Computer Graphics,” The Systems Programming Series, Chapter 7, Jul. 1984, pp. 245-266.
  • Foley et al., “Image-guided Intraoperative Spinal Localization,” Intraoperative Neuroprotection, Chapter 19, 1996, pp. 325-340.
  • Foley, “The StealthStation: Three-Dimensional Image-Interactive Guidance for the Spine Surgeon,” Spinal Frontiers, Apr. 1996, pp. 7-9.
  • Friets, E.M., et al. A Frameless Stereotaxic Operating Microscope for Neurosurgery, IEEE Trans. on Biomed. Eng., vol. 36, No. 6, pp. 608-617 (Jul. 1989).
  • Gallen, C.C., et al., Intracranial Neurosurgery Guided by Functional Imaging, Surg. Neurol., vol. 42, pp. 523-530 (1994).
  • Galloway, R.L., et al., Interactive Image-Guided Neurosurgery, IEEE Trans. on Biomed. Eng., vol. 89, No. 12, pp. 1226-1231 (1992).
  • Galloway, R.L., Jr. et al, Optical localization for interactive, image-guided neurosurgery, SPIE, vol. 2164, pp. 137-145 (undated.
  • Germano, “Instrumentation, Technique and Technology”, Neurosurgery, vol. 37, No. 2, Aug. 1995, pp. 348-350.
  • Gildenberg et al., “Calculation of Stereotactic Coordinates from the Computed Tomographic Scan,” Neurosurgery, vol. 10, No. 5, May 1982, pp. 580-586.
  • Gomez, C.R., et al., Transcranial Doppler Ultrasound Following Closed Head Injury: Vasospasm or Vasoparalysis?, Surg. Neurol., vol. 35, pp. 30-35 (1991).
  • Gonzalez, “Digital Image Fundamentals,” Digital Image Processing, Second Edition, 1987, pp. 52-54.
  • Gottesfeld Brown et al., “Registration of Planar Film Radiographs with Computer Tomography,” Proceedings of MMBIA, Jun. '96, pp. 42-51.
  • Grimson, W.E.L., An Automatic Registration Method for Frameless Stereotaxy, Image Guided Surgery, and enhanced Reality Visualization, IEEE, pp. 430-436 (1994).
  • Grimson, W.E.L., et al., Virtual-reality technology is giving surgeons the equivalent of x-ray vision helping them to remove tumors more effectively, to minimize surgical wounds and to avoid damaging critical tissues, Sci. Amer., vol. 280, No. 6, pp. 62-69 (Jun. 1999).
  • Gueziec et al., “Registration of Computed Tomography Data to a Surgical Robot Using Fluoroscopy: A Feasibility Study,” Computer Science/Mathematics, Sep. 27, 1996, 6 pages.
  • Guthrie, B.L., Graphic-Interactive Cranial Surgery: The Operating Arm System, Handbook of Stereotaxy Using the CRW Apparatus, Chapter 13, pp. 193-211 (undated.
  • Hamadeh et al, “Kinematic Study of Lumbar Spine Using Functional Radiographies and 3D/2D Registration,” TIMC UMR 5525—IMAG.
  • Hamadeh et al., “Automated 3-Dimensional Computed Tomographic and Fluoroscopic Image Registration,” Computer Aided Surgery (1998), 3:11-19.
  • Hamadeh et al., “Towards Automatic Registration Between CT and X-ray Images: Cooperation Between 3D/2D Registration and 2D Edge Detection,” MRCAS '95, pp. 39-46.
  • Hardy, T., M.D., et al., CASS: A Program for Computer Assisted Stereotaxic Surgery, The Fifth Annual Symposium on Comptuer Applications in Medical Care, Proceedings, Nov. 1-4, 1981, IEEE, pp. 1116-1126, (1981).
  • Hatch, “Reference-Display System for the Integration of CT Scanning and the Operating Microscope,” Thesis, Thayer School of Engineering, Oct. 1984, pp. 1-189.
  • Hatch, et al., “Reference-Display System for the Integration of CT Scanning and the Operating Microscope”, Proceedings of the Eleventh Annual Northeast Bioengineering Conference, Mar. 14-15, 1985, pp. 252-254.
  • Heilbrun et al., “Preliminary experience with Brown-Roberts-Wells (BRW) computerized tomography stereotaxic guidance system,” Journal of Neurosurgery, vol. 59, Aug, 1983, pp. 217-222.
  • Heilbrun, M.D., Progressive Technology Applications, Neurosurgery for the Third Millenium, Chapter 15, J. Whitaker & Sons, Ltd., Amer. Assoc. of Neurol. Surgeons, pp. 191-198 (1992).
  • Heilbrun, M.P., Computed Tomography—Guided Stereotactic Systems, Clinical Neurosurgery, Chapter 31, pp. 564-581 (1983).
  • Heilbrun, M.P., et al., Stereotactic Localization and Guidance Using a Machine Vision Technique, Sterotact & Funct. Neurosurg., Proceed. of the Mfg. of the Amer. Soc. for Sterot. and Funct. Neurosurg. (Pittsburgh, PA) vol. 58, pp. 94-98 (1992).
  • Henderson et al., “An Accurate and Ergonomic Method of Registration for Image-guided Neurosurgery,” Computerized Medical Imaging and Graphics, vol. 18, No. 4, Jul.-Aug. 1994, pp. 273-277.
  • Hoerenz, “The Operating Microscope I. Optical Principles, Illumination Systems, and Support Systems,” Journal of Microsurgery, vol. 1, 1980, pp. 364-369.
  • Hofstetter et al., “Fluoroscopy Based Surgical Navigation—Concept and Clinical Applications,” Computer Assisted Radiology and Surgery, 1997, pp. 956-960.
  • Horner et al., “A Comparison of CT-Stereotaxic Brain Biopsy Techniques,” Investigative Radiology, Sep.-Oct. 1984, pp. 367-373.
  • Hounsfield, “Computerized transverse axial scanning (tomography): Part 1. Description of system,” British Journal of Radiology, vol. 46, No. 552, Dec. 1973, pp. 1016-1022.
  • Jacques et al., “A Computerized Microstereotactic Method to Approach, 3-Dimensionally Reconstruct, Remove and Adjuvantly Treat Small CNS Lesions,” Applied Neurophysiology, vol. 43, 1980, pp. 176-182.
  • Jacques et al., “Computerized three-dimensional stereotaxic removal of small central nervous system lesion in patients,” J. Neurosurg., vol. 53, Dec. 1980, pp. 816-820.
  • Joskowicz et al., “Computer-Aided Image-Guided Bone Fracture Surgery: Concept and Implementation,” CAR '98, pp. 710-715.
  • Kall, B., The Impact of Computer and Imgaging Technology on Stereotactic Surgery, Proceedings of the Meeting of the American Society for Stereotactic and Functional Neurosurgery, pp. 10-22 (1987).
  • Kato, A., et al., A frameless, armless navigational system for computer-assisted neurosurgery, J. Neurosurg., vol. 74, pp. 845-849 (May 1991).
  • Kelly et al., “Computer-assisted stereotaxic laser resection of intra-axial brain neoplasms,” Journal of Neurosurgery, vol. 64, Mar. 1986, pp. 427-439.
  • Kelly et al., “Precision Resection of Intra-Axial CNS Lesions by CT-Based Stereotactic Craniotomy and Computer Monitored CO2 Laser,” Acta Neurochirurgica, vol. 68, 1983, pp. 1-9.
  • Kelly, P.J., Computer Assisted Stereotactic Biopsy and Volumetric Resection of Pediatric Brain Tumors, Brain Tumors in Children, Neurologic Clinics, vol. 9, No. 2, pp. 317-336 (May 1991).
  • Kelly, P.J., Computer-Directed Stereotactic Resection of Brain Tumors, Neurologica Operative Atlas, vol. 1, No. 4, pp. 299-313 (1991).
  • Kelly, P.J., et al., Results of Computed Tomography-based Computer-assisted Stereotactic Resection of Metastatic Intracranial Tumors, Neurosurgery, vol. 22, No. 1, Part 1, 1988, pp. 7-17 (Jan. 1988).
  • Kelly, P.J., Stereotactic Imaging, Surgical Planning and Computer-Assisted Resection of Intracranial Lesions: Methods and Results, Advances and Technical Standards in Neurosurgery, vol. 17, pp. 78-118, (1990).
  • Kim, W.S. et al., A Helmet Mounted Display for Telerobotics, IEEE, pp. 543-547 (1988).
  • Klimek, L., et al., Long-Term Experience with Different Types of Localization Systems in Skull-Base Surgery, Ear, Nose & Throat Surgery, Chapter 51, pp. 635-638 (undated).
  • Kosugi, Y., et al., An Articulated Neurosurgical Navigation System Using MRI and CT Images, IEEE Trans. on Biomed, Eng. vol. 35, No. 2, pp. 147-452 (Feb. 1988).
  • Krybus, W. et al., Navigation Support for Surgery by Means of Optical Position Detection, Computer Assisted Radiology Proceed. of the Intl. Symp. CAR '91 Computed Assisted Radiology, pp. 362-366 (Jul. 3-6, 1991).
  • Kwoh, Y.S., Ph.D., et al., A New Computerized Tomographic-Aided Robotic Stereotaxis System, Robotics Age, vol. 7, No. 6, pp. 17-22 (Jun. 1985).
  • Laitinen et al., “An Adapter for Computed Tomography-Guided, Stereotaxis,” Surg. Neurol., 1985, pp. 559-566.
  • Laitinen, “Noninvasive multipurpose stereoadapter,” Neurological Research, Jun. 1987, pp. 137-141.
  • Lavallee et al, “Matching 3-D Smooth Surfaces with their 2-D Projections using 3-D Distance Maps,” SPIE, vol. 1570, Geometric Methods in Computer Vision, 1991, pp. 322-336.
  • Lavallee et al., “Computer Assisted Driving of a Needle into the Brain,” Proceedings of the International Symposium CAR '89, Computer Assisted Radiology, 1989, pp. 416-420.
  • Lavallee et al., “Computer Assisted Interventionist Imaging: The Instance of Stereotactic Brain Surgery,” North-Holland MEDINFO 89, Part 1, 1989, pp. 613-617.
  • Lavallee et al., “Computer Assisted Spine Surgery: A Technique For Accurate Transpedicular Screw Fixation Using CT Data and a 3-D Optical Localizer,” TIMC, Faculte de Medcine de Grenoble.
  • Lavallee et al., “Image guided operating robot: a clinical application in stereotactic neurosurgery,” Proceedings of the 1992 IEEE Internation Conference on Robotics and Automation, May 1992, pp. 618-624.
  • Lavallee et al., “Matching of Medical Images for Computed and Robot Assisted Surgery,” IEEE EMBS, Orlando, 1991.
  • Lavallee, “A New System for Computer Assisted Neurosurgery,” IEEE Engineering in Medicine & Biology Society 11th Annual International Conference, 1989, pp. 0926-0927.
  • Lavallee, “VI Adaption de la Methodologie a Quelques Applications Cliniques,” Chapitre VI, pp. 133-148.
  • Lavallee, S., et al., Computer Assisted Knee Anterior Cruciate Ligament Reconstruction First Clinical Tests, Proceedings of the First International Symposium on Medical Robotics and Computer Assisted Surgery, pp. 11-16 (Sep. 1994).
  • Lavallee, S., et al., Computer Assisted Medical Interventions, NATO ASI Series, vol. F 60, 3d Imaging in Medic., pp. 301-312 (1990).
  • Leavitt, D.D., et al., Dynamic Field Shaping to Optimize Stereotactic Radiosurgery, I.J. Rad. Onc. Biol. Physc., vol. 21, pp. 1247-1255 (1991).
  • Leksell et al., “Stereotaxis and Tomography—A Technical Note,” ACTA Neurochirurgica, vol. 52, 1980, pp. 1-7.
  • Lemieux et al., “A Patient-to-Computed-Tomography Image Registration Method Based on Digitally Reconstructed Radiographs,” Med. Phys. 21 (11), Nov. 1994, pp. 1749-1760.
  • Levin et al., “The Brain: Integrated Three-dimensional Display of MR and PET Images,” Radiology, vol. 172, No. 3, Sep. 1989, pp. 783-789.
  • Maurer, Jr., et al., Registration of Head CT Images to Physical Space Using a Weighted Combination of Points and Surfaces, IEEE Trans. on Med. Imaging, vol. 17, No. 5, pp. 753-761 (Oct. 1998).
  • Mazier et al., “Computer-Assisted Interventionist Imaging: Application to the Vertebral Column Surgery,” Annual International Conference of the IEEE Engineering in Medicine and Biology Society, vol. 12, No. 1, 1990, pp. 0430-0431.
  • Mazier et al., Chirurgie de la Colonne Vertebrale Assistee par Ordinateur: Application au Vissage Pediculaire, Innov. Tech. Biol. Med., vol. 11, No. 5, 1990, pp. 559-566.
  • McGirr, S., M.D., et al., Stereotactic Resection of Juvenile Pilocytic Astrocytomas of the Thalamus and Basal Ganglia, Neurosurgery, vol. 20, No. 3, pp. 447-452, (1987).
  • Merloz, et al., “Computer Assisted Spine Surgery”, Clinical Assisted Spine Surgery, No. 337, pp. 86-96.
  • Ng, W.S. et al., Robotic Surgery—A First-Hand Exeperience in Transurethral Resection of the Prostate Surgery, IEEE Eng. in Med. and Biology, pp. 120-125 (Mar. 1993).
  • Pelizzari et al., “Accurate Three-Dimensional Registration of CT, PET, and/or MR Images of the Brain,” Journal of Computer Assisted Tomography, Jan./Feb. 1989, pp. 20-26.
  • Pelizzari et al., “Interactive 3D Patient-Image Registration,” Information Processing in Medical Imaging, 12th International Conference IPMI '91, Jul. 7-12, 136-141 (A.C.F. Colchester et al. eds. 1991).
  • Pelizzari et al., No. 528—“Three Dimensional Correlation of PET, CT and MRI Images,” The Journal of Nuclear Medicine, vol. 28, No. 4, Apr. 1987, p. 682.
  • Penn, R.D., et al., Stereotactic Surgery with Image Processing of Computerized Tomographic Scans, Neurosurgery, vol. 3, No. 2, pp. 157-163 (Sep.-Oct. 1978).
  • Phillips et al., “Image Guided Orthopaedic Surgery Design and Analysis,” Trans Inst. MC, vol. 17, No. 5, 1995, pp. 251-264.
  • Pixsys, 3-D Digitizing Accessories, by Pixsys (marketing brochure)(undated) (2 pages).
  • Potamianos et al., “Intra-Operative Imaging Guidance for Keyhole Surgery Methodology and Calibration,” First International Symposium on Medical Robotics and Computer Assisted Surgery, Sep. 22-24, 1994, pp. 98-104.
  • Prestige Cervical Disc System Surgical Technique, 12 pgs.
  • Reinhardt et al., “CT-Guided ‘Real Time’ Stereotaxy,” ACTA Neurochirurgica, 1989.
  • Reinhardt, H., et al., A Computer-Assisted Device for Intraoperative CT-Correlated Localization of Brain Tumors, pp. 51-58 (1988).
  • Reinhardt, H.F. et al., Sonic Stereometry in Microsurgical Procedures for Deep-Seated Brain Tumors and Vascular Malformations, Neurosurgery, vol. 32, No. 1, pp. 51-57 (Jan. 1993).
  • Reinhardt, H.F., et al., Mikrochirugische Entfernung tiefliegender Gefäβmiβbildungen mit Hilfe der Sonar-Stereometrie (Microsurgical Removal of Deep-Seated Vascular Malformations Using Sonar Stereometry). Ultraschall in Med. 12, pp. 80-83 (1991).
  • Reinhardt, Hans. F., Neuronavigation: A Ten-Year Review, Neurosurgery, pp. 329-341 (undated).
  • Roberts et al., “A frameless stereotaxic integration of computerized tomographic imaging and the operating microscope,” J. Neurosurg., vol. 65, Oct. 1986, pp. 545-549.
  • Rosenbaum et al., “Computerized Tomography Guided Stereotaxis: A New Approach,” Applied Neurophysiology, vol. 43, No. 3-5, 1980, pp. 172-173.
  • Sautot, “Vissage Pediculaire Assiste Par Ordinateur,” Sep. 20, 1994.
  • Schueler et al., “Correction of Image Intensifier Distortion for Three-Dimensional X-Ray Angiography,” SPIE Medical Imaging 1995, vol. 2432, pp. 272-279.
  • Selvik et al., “A Roentgen Stereophotogrammetric System,” Acta Radiologica Diagnosis, 1983, pp. 343-352.
  • Shelden et al., “Development of a computerized microsteroetaxic method for localization and removal of minute CNS lesions under direct 3-D vision,” J. Neurosurg., vol. 52, 1980, pp. 21-27.
  • Simon, D.A., Accuracy Validation in Image-Guided Orthopaedic Surgery, Second Annual Intl. Symp. on Med. Rob. an Comp-Assisted Surgery, MRCAS '95, pp. 185-192 (undated).
  • Smith et al., “Computer Methods for Improved Diagnostic Image Display Applied to Stereotactic Neurosurgery,” Automedical, vol. 14, 1992, pp. 371-382 (4 unnumbered pages).
  • Smith et al., “The Neurostation™—A Highly Accurate, Minimally Invasive Solution to Frameless Stereotactic Neurosurgery,” Computerized Medical Imaging and Graphics, vol. 18, Jul.-Aug. 1994, pp. 247-256.
  • Smith, K.R., et al. Multimodality Image Analysis and Display Methods for Improved Tumor Localization in Stereotactic Neurosurgery, Annul Intl. Conf. of the IEEE Eng. in Med. and Biol. Soc., vol. 13, No. 1, p. 210 (1991).
  • Tan, K., Ph.D., et al., A frameless stereotactic approach to neurosurgical planning based on retrospective patient-image registration, J Neurosurgy, vol. 79, pp. 296-303 (Aug. 1993).
  • The Laitinen Stereotactic System, E2-E6.
  • Thompson, et al., A System for Anatomical and Functional Mapping of the Human Thalamus, Computers and Biomedical Research, vol. 10, pp. 9-24 (1977).
  • Trobraugh, J.W., et al., Frameless Stereotactic Ultrasonography: Method and Applications, Computerized Medical Imaging and Graphics, vol. 18, No. 4, pp. 235-246 (1994).
  • Viant et al., “A Computer Assisted Orthopaedic System for Distal Locking of Intramedullary Nails,” Proc. of MediMEC '95, Bristol, 1995, pp. 86-91.
  • Von Hanwhr et al., Foreword, Computerized Medical Imaging and Graphics, vol. 18, No. 4, pp. 225-228, (Jul.-Aug. 1994).
  • Wang, M.Y., et al., An Automatic Technique for Finding and Localizing Externally Attached Markers in CT and MR Volume Images of the Head, IEEE Trans. on Biomed. Eng., vol. 43, No. 6, pp. 627-637 (Jun. 1996).
  • Watanabe et al., “Three-Dimensional Digitizer (Neuronavigator): New Equipment for Computed Tomography-Guided Stereotaxic Surgery,” Surgical Neurology, vol. 27, No. 6, Jun. 1987, pp. 543-547.
  • Watanabe, “Neuronavigator,” Igaku-no-Ayumi, vol. 137, No. 6, May 10, 1986, pp. 1-4.
  • Watanabe, E., M.D., et al., Open Surgery Assisted by the Neuronavigator, a Stereotactic, Articulated, Sensitive Arm, Neurosurgery, vol. 28, No. 6, pp. 792-800 (1991).
  • Weese et al., “An Approach to 2D/3D Registration of a Vertebra in 2D X-ray Fluoroscopies with 3D CT Images,” pp. 119-128.
  • Office Action mailed Dec. 12, 2008 in pending U.S. Appl. No. 11/451,595, filed Jun. 12, 2006.
  • Office Action mailed Sep. 21, 2009 in pending U.S. Appl. No. 11/451,595, filed Jun. 12, 2006.
Patent History
Patent number: RE42194
Type: Grant
Filed: Jun 12, 2006
Date of Patent: Mar 1, 2011
Assignee: Medtronic Navigation, Inc. (Louisville, CO)
Inventors: Kevin T. Foley (Germantown, TN), John B. Clayton (Superior, CO), Anthony Melkent (Memphis, TN), Michael Sherman (Memphis, TN)
Primary Examiner: George Manuel
Attorney: Harness, Dickey
Application Number: 11/451,594
Classifications
Current U.S. Class: Using Fiducial Marker (600/426)
International Classification: A61B 5/05 (20060101);