Patent Description:
A procedure can be performed on any appropriate subject. For example, a procedure can be performed on a patient to position an implant in the patient. Though procedures can also include assembling any appropriate work piece or installing members into a work piece, such as an airframe, autoframe, etc. Regardless of the subject, generally the procedure can have a selected result that is efficacious. The efficacious result may be the desired or best result for the procedure.

A procedure on a human patient can be a surgical procedure performed to insert an implant, such as a pedicle screw. The pedicle screw can be placed in the patient according to appropriate techniques, such as an open procedure where a surgeon can view the procedure. Also, procedures can include hole drilling, screw placement, vessel stent placement, deep brain stimulation, etc..

A transponder with overlapping coil antennas on a common core is disclosed in <CIT>. <CIT> relates to a method and apparatus for treating cardiac arrhythmias by ablating in a vicinity of pulmonary venous tissue using radiofrequency energy, and discloses a catheter provided with a sensor, which sensor may consist of a single coil, or have two or more and even three sensor coils wound on either air cores or a core of material. <CIT> also discloses that a barrel-shaped coil can have more turns than a cylindrical coil of the same diameter.

The present invention is defined by the features of the independent claims.

A surgical procedure can be performed with a navigated instrument. The navigated instrument can have associated therewith, such as attached directly to or relative to a surgical instrument, a tracking device to track a location of the instrument. The tracking device can be interconnected directly, such as wrapped around or positioned around a portion of an instrument, or extend from a mounting device connected to the instrument. According to various embodiments, a surgical procedure can be performed using a small or low invasive instrument. A small or low invasive instrument, however, may require or benefit from a small tracking device associated with an instrument for tracking a location of the instrument while minimizing a space or volume consumed by the tracking device itself. Accordingly a tracking device can be provided that is wrapped around an axis of an instrument, embedded in a surface of an instrument, or positioned or embedded in an interior of an instrument to minimize a dimensional increase due to the inclusion of a tracking device. Such instruments may also be used for air frame assembly or small (e.g. robotic) system repair.

According to various embodiments, a tracking device can be attached or interconnected with various portions in a navigation system. For example, a tracking device can be wrapped around or integrated into a portion of an instrument, such as in a shaft of a stylet or on a shaft of a stylet. Alternatively, or in addition thereto, a tracking device can be formed separately and connected, such as with a connection member with an instrument to be tracked. Accordingly, an instrument can include a tracking device that is wrapped directly around or placed directly on a portion of the instrument or it can be separately interconnected with a portion of the instrument. For example, the tracking device can be clipped or passed over a portion of the instrument.

<FIG> is a diagram illustrating an overview of a navigation system <NUM> that can be used for various procedures. The navigation system <NUM> can be used to track the location of an item, such as an implant or an instrument (e.g. <NUM> as discussed herein), relative to a subject, such as a patient <NUM>. It should further be noted that the navigation system <NUM> may be used to navigate any type of instrument, implant, or delivery system, including: guide wires, arthroscopic systems, orthopedic implants, spinal implants, deep brain stimulation (DBS) probes, etc. Non-human or surgical procedures may also use the instrument <NUM> and the navigation system <NUM>. Moreover, the instruments may be used to navigate or map any region of the body. The navigation system <NUM> and the various tracked items may be used in any appropriate procedure, such as one that is generally minimally invasive or an open procedure.

The navigation system <NUM> can interface with or integrally include an imaging system <NUM> that is used to acquire pre-operative, intraoperative, or post-operative, or real-time image data of the patient <NUM>. It will be understood, however, that any appropriate subject can be imaged and any appropriate procedure may be performed relative to the subject. In the example shown, the imaging system <NUM> comprises an O-arm® imaging device sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado, USA. The imaging device <NUM> includes imaging portions such as a generally annular gantry housing <NUM> that encloses an image capturing portion <NUM>. The image capturing portion <NUM> may include an x-ray source or emission portion <NUM> and an x-ray receiving or image receiving portion <NUM>. The emission portion <NUM> and the image receiving portion <NUM> are generally spaced about <NUM> degrees from each other and mounted on a rotor (not illustrated) relative to a track of the image capturing portion <NUM>. The image capturing portion <NUM> can be operable to rotate <NUM> degrees during image acquisition. The image capturing portion <NUM> may rotate around a central point or axis, allowing image data of the patient <NUM> to be acquired from multiple directions or in multiple planes.

The imaging system <NUM> can include those disclosed in <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>. The imaging system <NUM> can also include or be associated with various image processing systems, as discussed herein. Other possible imaging systems can include C-arm fluoroscopic imaging systems which can also be used to generate three-dimensional views of the patient <NUM>. It is also understood that other appropriate imaging systems can be used such as magnetic resonance imaging (MRI), positron emission tomography imaging (PET), etc..

The patient <NUM> can be fixed onto an operating table <NUM>, but is not required to be fixed to the table <NUM>. The table <NUM> can include a plurality of straps <NUM>. The straps <NUM> can be secured around the patient <NUM> to fix the patient <NUM> relative to the table <NUM>. Various apparatuses may be used to position the patient <NUM> in a static position on the operating table <NUM>. Examples of such patient positioning devices are set forth in commonly assigned <CIT>, <CIT>, entitled "An Integrated Electromagnetic Navigation And Patient Positioning Device", filed April <NUM>, <NUM>. Other known apparatuses may include a Mayfield® clamp.

The navigation system <NUM> includes a tracking system <NUM> that can be used to track instruments relative to the patient <NUM> or within a navigation space. The navigation system <NUM> can use image data from the imaging system <NUM> and information from the tracking system <NUM> to illustrate locations of the tracked instruments, as discussed herein. The tracking system <NUM> can include a plurality of types of tracking systems including an optical tracking system that includes an optical localizer <NUM> and/or an electromagnetic (EM) tracking system that can include an EM localizer <NUM> that communicates with or through an EM controller <NUM>. The optical tracking system <NUM> and the EM tracking system with the EM localizer <NUM> can be used together to track multiple instruments or used together to redundantly track the same instrument. Various tracking devices, including those discussed further herein, can be tracked with the tracking system <NUM> and the information can be used by the navigation system <NUM> to allow for an output system to output, such as a display device to display, a position of an item. Briefly, tracking devices, such as a patient tracking device (to track the patient <NUM>) <NUM>, an imaging device tracking device <NUM> (to track the imaging device <NUM>), and an instrument tracking device <NUM> (to track the instrument <NUM>), allow selected portions of the operating theater to be tracked relative to one another with the appropriate tracking system, including the optical localizer <NUM> and/or the EM localizer <NUM>.

It will be understood that any of the tracking devices <NUM>-<NUM> can be optical or EM tracking devices, or both, depending upon the tracking localizer used to track the respective tracking devices. It will be further understood that any appropriate tracking system can be used with the navigation system <NUM>. Alterative tracking systems can include radar tracking systems, acoustic tracking systems, ultrasound tracking systems, and the like.

An exemplarily EM tracking system can include the STEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado. Exemplary tracking systems are also disclosed in <CIT> and entitled "METHOD AND APPARATUS FOR SURGICAL NAVIGATION"; <CIT> and <CIT>.

Further, for EM tracking systems it may be necessary to provide shielding or distortion compensation systems to shield or compensate for distortions in the EM field generated by the EM localizer <NUM>. Exemplary shielding systems include those in <CIT> and <CIT>; distortion compensation systems can include those disclosed in <CIT>, published as <CIT>.

With an EM tracking system, the localizer <NUM> and the various tracking devices can communicate through the EM controller <NUM>. The EM controller <NUM> can include various amplifiers, filters, electrical isolation, and other systems. The EM controller <NUM> can also control the coils of the localizer <NUM> to either emit or receive an EM field for tracking. A wireless communications channel, however, such as that disclosed in <CIT>, can be used as opposed to being coupled directly to the EM controller <NUM>.

It will be understood that the tracking system may also be or include any appropriate tracking system, including a STEALTHSTATION® TRIA®, TREON®, and/or S7™ Navigation System having an optical localizer, similar to the optical localizer <NUM>, sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado. Further alternative tracking systems are disclosed in <CIT>. Other tracking systems include an acoustic, radiation, radar, etc. tracking or navigation systems.

The imaging system <NUM> can further include a support housing or cart <NUM> that can house a separate image processing unit <NUM>. The cart can be connected to the gantry <NUM>. The navigation system <NUM> can include a navigation processing unit <NUM> that can communicate or include a navigation memory <NUM>. The navigation processing unit <NUM> can include a processor (e.g. a computer processor) that executes instructions to determine locations of the tracking devices <NUM>-<NUM> based or signals from the tracking devices. The navigation processing unit <NUM> can receive information, including image data, from the imaging system <NUM> and tracking information from the tracking systems <NUM>, including the respective tracking devices <NUM>-<NUM> and the localizers <NUM>-<NUM>. Image data can be displayed as an image <NUM> on a display device <NUM> of a workstation or other computer system <NUM> (e.g. laptop, desktop, tablet computer which may have a central processor to act as the navigation processing unit <NUM> by executing instructions). The workstation <NUM> can include appropriate input devices, such as a keyboard <NUM>. It will be understood that other appropriate input devices can be included, such as a mouse, a foot pedal or the like which can be used separately or in combination. Also, all of the disclosed processing units or systems can be a single processor (e.g. a single central processing chip) that can execute different instructions to perform different tasks.

The image processing unit <NUM> processes image data from the imaging system <NUM> and transmits it to the navigation processor <NUM>. It will be further understood, however, that the imaging system <NUM> need not perform any image processing and it can transmit the image data directly to the navigation processing unit <NUM>. Accordingly, the navigation system <NUM> may include or operate with a single or multiple processing centers or units that can access single or multiple memory systems based upon system design.

In various embodiments, the imaging system <NUM> can generate image data that can be registered to the patient space or navigation space. In various embodiments, the position of the patient <NUM> relative to the imaging system <NUM> can be determined by the navigation system <NUM> with the patient tracking device <NUM> and the imaging system tracking device <NUM> to assist in registration. Accordingly, the position of the patient <NUM> relative to the imaging system <NUM> can be determined.

Alternatively, or in addition to tracking the imaging system <NUM>, the imaging system <NUM>, such as the O-arm® imaging system, can know its position and be repositioned to the same position within about <NUM> microns. This allows for a substantially precise placement of the imaging system <NUM> and precise determination of the position of the imaging device <NUM>. Precise positioning of the imaging portion <NUM> is further described in <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

Subject or patient space and image space can be registered by identifying matching points or fiducial points in the patient space and related or identical points in the image space. When the position of the imaging device <NUM> is known, either through tracking or its "known" position (e.g. O-arm® imaging device sold by Medtronic, Inc. ), or both, the image data is generated at a precise and known position. This can allow image data that is automatically or "inherently registered" to the patient <NUM> upon acquisition of the image data. Essentially, the position of the patient <NUM> is known precisely relative to the imaging system <NUM> due to the accurate positioning of the imaging system <NUM>. This allows points in the image data to be known relative to points of the patient <NUM> because of the known precise location of the imaging system <NUM>.

Alternatively, manual or automatic registration can occur by matching fiducial points in image data with fiducial points on the patient <NUM>. Registration of image space to patient space allows for the generation of a translation map between the patient space and the image space. According to various embodiments, registration can occur by determining points that are substantially identical in the image space and the patient space. The identical points can include anatomical fiducial points or implanted fiducial points. Exemplary registration techniques are disclosed in <NUM>/<NUM>,<NUM> (<CIT>.

Once registered, the navigation system <NUM> with or including the imaging system <NUM>, can be used to perform selected procedures. Selected procedures can use the image data generated or acquired with the imaging system <NUM>. Further, the imaging system <NUM> can be used to acquire image data at different times relative to a procedure. As discussed herein, image data can be acquired of the patient <NUM> subsequent to a selected portion of a procedure for various purposes, including confirmation of the portion of the procedure.

With continuing reference to <FIG>, the imaging system <NUM> can generate actual three dimensional images of the patient <NUM> or virtual three dimensional images based on the image data, which can be registered to the patient/navigation space. The patient <NUM> can be placed relative to the imaging system <NUM> to allow the imaging system <NUM> to obtain image data of the patient <NUM>. To generate 3D image data, the image data can be acquired from a plurality of views or positions relative to the patient <NUM>. The 3D image data of the patient <NUM> can be used alone or with other information to assist in performing a procedure on the patient <NUM> or an appropriate subject. It will be understood, however, that any appropriate imaging system can be used, including magnetic resonance imaging, computed tomography, fluoroscopy, etc..

As generally illustrated in <FIG>, the navigation system <NUM> can be used to navigate the instrument <NUM> relative to the patient <NUM>. The navigation can be imageless (e.g. only illustrating icons at tracked locations of different tracked portions) or with images. Images can include acquired images (e.g. with the imaging system <NUM> or atlas images). Regardless, icons with or without images can be displayed on the display device <NUM>. The tracking system <NUM> can track the instrument <NUM> and the navigation processing unit <NUM> can be used to determine the location of the instrument <NUM> and display the location of the instrument on the display <NUM> relative to the image <NUM> or, as mentioned above, without the image <NUM>. Accordingly, according to various embodiments, such as those discussed herein, the user <NUM> can view an icon representing a location of the instrument <NUM> relative to the patient <NUM> or a selected portion of the patient <NUM> with or without images on the display <NUM>. In so viewing the icons the user <NUM> can know the location of the instrument <NUM> in subject/patient space based upon the tracked location of the instrument <NUM> in image space.

The tracking device <NUM> can include various features, such as those discussed herein. In an EM tracking system <NUM> the tracking device <NUM> can include one or more coils that can either transmit an EM field or sense an EM field to generate a tracking signal (also referred to as an EM signal) to allow the navigation system <NUM> to determine the location of the tracked instrument <NUM> in the navigation space. The coils of the tracking device <NUM> can be formed as a wire wrapped around a core (e.g. formed of a solid material or air) or axis that can sense the magnetic field by generating a current within the wire or transmit an EM field that can be sensed by a sensing or localizer coil. The tracking device <NUM> can be formed directly on a device, as illustrated below, or, according to various embodiments, be connected to the instrument <NUM> to be tracked, as illustrated in <FIG>.

As discussed above in relation to <FIG>, the navigation system <NUM> can include the various localizers <NUM>, <NUM> relative to respective tracking devices <NUM> associated with the instrument <NUM>, which can be a guide tube. The instrument <NUM>, as illustrated in <FIG>, can be any appropriate instrument as exemplarily illustrated as a guide tube including a cannula or bore <NUM> extending along a length of the guide tube <NUM>. It will be understood, however, that the instrument <NUM> can also include or be formed as a drill bit, a probe, or any other appropriate instrument. Additionally, the guide tube <NUM> can be substantially solid or itself designed as the tracking device <NUM> that can be associated with other instruments to be navigated with the navigation system <NUM>.

The tracking device <NUM> is formed as a plurality of winds of wire <NUM> formed around an exterior or on an exterior wall <NUM> of the instrument <NUM> to form a coil. The winds or turns of wire <NUM> are formed between guide posts <NUM> and can include a plurality of guide posts <NUM> that are formed or positioned at selected positions on the external wall <NUM> of the guide tube <NUM>. There may be a plurality of turns of the wire <NUM> between each guide post (e.g. <FIG>) or there may be one turn of the wire <NUM> between each guide post (e.g. <NUM>, <FIG>). The wire can be insulated so that it is insulated from the instrument <NUM> and the next turn of the wire. It will also be understood that a portion including the coil of wire can be connected to the instrument to perform as the tracking device <NUM>. For example, a sleeve with the coil of wire can be fit over an outer wall of the instrument <NUM>.

With additional reference to <FIG>, the guide posts <NUM> can extend from the external wall <NUM> to a height above the external wall <NUM>. Alternatively, the posts <NUM> can be understood to define a maximum diameter of the instrument <NUM> and the wire <NUM> is wound, at least initially, within the maximum diameter. In other words, the wire <NUM> can be maintained below the height of the posts <NUM> or can be wound over top of the posts <NUM>. The posts <NUM>, however, may provide the greatest degree of guiding or support for the wire <NUM> when the wire <NUM> is between and below an outer edge of the posts <NUM>.

The guide posts <NUM> are formed on the instrument <NUM> can include a slanted or guiding wall <NUM> and a support or second wall <NUM>. Both the guide wall <NUM> and the support wall <NUM> can extend to an outer wall <NUM>. The outer wall <NUM> can define an outer diameter or perimeter of the instrument <NUM>. The posts <NUM> can also define a width 114w. The width 114w can be selected to engage the wire <NUM> in a manner to selectively hold the wire <NUM> or to cover a selected expanse of the instrument outer wall <NUM>. Also, the posts <NUM> can be formed separately and adhered or fixed to the outer wall <NUM> (e.g. with adhesives, welding, threaded engagement) or can be formed as a single piece with the outer wall <NUM> (e.g. molding or machining the posts <NUM> from the outer wall <NUM>).

The guide wall <NUM> has a surface that can extend along a plane or line <NUM> that extends at an angle 116a relative to a long axis <NUM> of the guide tube <NUM>. The guide wall <NUM> can be the entire width 114w of the post or can be a selected portion thereof. It will also be understood, however, that the guide wall <NUM> need not be angled. For example, when a first post <NUM> is formed on the instrument and a second post <NUM> is formed on the instrument the first and second post can be axially positioned relative to one another such that when the wire <NUM> is wound the instrument <NUM> the wire <NUM> will achieve a selected angle to form the navigation vector, as discussed herein.

It will be understood that the long axis <NUM> can be a long axis of any appropriate instrument. Generally, the long axis <NUM> is substantially aligned with an end or length of the instrument <NUM> such that the long axis <NUM> substantially defines a line or trajectory of the instrument <NUM>. Also, a second instrument may pass through the tube <NUM> the instrument, such as a needle, generally along the long axis <NUM> and through an end of a guide tube <NUM>. Thus, the long axis <NUM> generally defines a long axis or real trajectory of an instrument or a portion being guided through a guide portion of an instrument relative to a subject. The long axis <NUM>, however, may be any axis of the instrument <NUM> and may only be aligned with a long axis of the instrument <NUM>. It will be understood, however, that the instrument need not be rigidly straight, but can be bent, curved, flexible, or otherwise moveable. Thus, the long axis <NUM> may refer to a long axis of a selected portion of the instrument <NUM> that may not be continuous for an entire length of the instrument <NUM>.

The angle 116a can be selected from any appropriate angle. Generally, however, the angle 116a will be about <NUM> degrees to about <NUM> degrees, including about <NUM> degrees to about <NUM> degrees, and further including about <NUM> degrees to about <NUM> degrees relative to the long axis <NUM>. As discussed in <CIT> and published as <CIT>, providing an angle between a wrapped winding or coil of wire relative to the long axis <NUM> can provide for forming a tracking device relative to the instrument <NUM> that can determine an orientation or position of the instrument in multiple degrees of freedom. It is understood, as disclosed herein, having multiple coils at various angles relative to one another can increase the degrees of freedom tracking information (e.g. three dimensional position information and three degrees of orientation information, which can include yaw, pitch, and roll of the instrument). For example, one coil of wire can generally provide five degrees of freedom of location information (e.g. three position degrees and two orientation degrees). An additional coil affixed to a single device (e.g. the instrument <NUM>) can be used to solve for six degree of freedom location information including three position degrees and three orientation degrees for a single instrument. Additional coils (e.g. three or more total coils) can be provided or used for redundancy and increased information for location determination of the instrument. Generally, location is understood to include both position and orientation information.

As illustrated in <FIG>, the coil winding <NUM> can include one or multiple wires. The coil winding can also include a single wire that is wound multiple times around the instrument and to engage the angled surface <NUM>. Accordingly, a winding angle of the wire <NUM> can be defined along the axis or a line <NUM> and generally defines an angle 122a that is similar to the angle 116a defined by the guide wall <NUM> relative to the long axis <NUM>. The angle 122a is achieved by contacting the wire <NUM> against the guide wall <NUM> as the wire <NUM> is being wound around the instrument <NUM>. By contacting the guide wall <NUM>, the wire <NUM> can be guided and maintained at the selected angle 122a relative to the long axis <NUM> of the instrument <NUM>. It will be understood that if multiple windings are used next to each of the posts <NUM> then each successive winding may contact the previous wind of wire and not the angled wall <NUM> directly, as illustrated in <FIG>.

Also, as illustrated in <FIG>, the posts <NUM> can be positioned around the instrument <NUM>, such as on opposed sides. However, it will be understood, that the posts <NUM> can be positioned at various offsets around the instrument <NUM>. For example, the posts <NUM> can be positioned <NUM> degrees from each other around the instrument <NUM> and displaced axially for each successive post <NUM>. Moreover, positioning the posts <NUM> displaced axially along the instrument <NUM> can allow for achieving the angle 122a without the angled wall <NUM>. As illustrated in <FIG>, the wire <NUM> can be wound to contact an axially displaced post <NUM> to achieve the angle 122a.

The angled wall <NUM> can also be provided to assist in the angle 122a creation or initiation, as illustrated in <FIG>. In addition, the angled wall can assist in creating clearance for winding of the wire <NUM>. For example, the angle between the top surface <NUM> and the wall <NUM> reduces or eliminates a snag or catch point (e.g. the corner created by a right angle between the walls) for the wire <NUM>. Also, the angled wall allows for tight winding of additional layers of wires laid on the first or previous winding layer.

The selected angle 122a, as discussed herein, allows for the generation of a navigation vector <NUM> that is at an angle 124a relative to the long axis <NUM> and complementary to the angle 122a. The navigation vector <NUM> can generally be defined with the navigation system <NUM> by sensing a magnetic field with the tracking device <NUM> (e.g. having a current induced in the tracking device) defined by the plurality of windings <NUM> of wire or by emitting a field from the tracking device <NUM> to be sensed by the localizer <NUM>. In other words, the navigation vector is defined in part by the position of the tracking device, but the vector is defined when used with the navigation system <NUM> by sensing the magnetic field or emitting a magnetic field. Regardless, the navigation vector <NUM> generally defines the angle 124a relative to the long axis <NUM> as disclosed in <CIT>.

With additional reference to <FIG>, it will be understood that a single or a plurality of windings can be provided on the instrument <NUM>, according to various embodiments. For example, as illustrated in <FIG>, according to various embodiments an instrument <NUM>' can include a plurality of guide posts <NUM> associated with the instrument <NUM>'. A first number or a plurality of the guide posts <NUM>' can include or have a first angled wall <NUM> that directs or causes the windings of the wire <NUM> to be formed relative to a long axis <NUM>' of the instrument <NUM> along an axis <NUM> thus forming an angle 144a relative to the long axis. The first angle or angle 144a can be an acute angle relative to the long axis <NUM>'. Also, a plurality of windings, such as at least a second winding <NUM>', can be provided between each post <NUM>'. A second portion or plurality of the guide post <NUM> can include the guide posts <NUM>" that have a second guide wall <NUM> that will cause or form the wire <NUM> to be wrapped along an axis <NUM> relative to the long axis <NUM>' of the instrument <NUM> and form an angle 152a relative to the long axis <NUM>'. The angle 152a can generally be an angle different than the angle 144a and can include a substantially <NUM> degree angle relative to the long axis <NUM>. Finally, a plurality of the guide posts <NUM> can include the posts <NUM>‴ and include a guide wall <NUM> that would cause the winding of the wire <NUM> to be formed along an axis <NUM> to form an angle 158a relative to the long axis <NUM>'. The fifth angle 158a can generally be an angle different than the angle 144a and the angle 152a and generally, as illustrated, be an obtuse angle relative to the long axis <NUM>'. It will be understood that each of the different coils can be at substantially orthogonal angles relative to one another, but is not required. Also, as discussed above three coils is not required for six degree of freedom location information.

As illustrated in <FIG>, a plurality of tracking device portions can be used to form the tracking device <NUM>. The tracking device portions can include windings of the wire <NUM> that are formed at a plurality of angles, such as three angles, relative to the long axis <NUM>' of the instrument <NUM>'. Each of the different windings that are at different angles relative to the long axis <NUM>' can be substantially separated or insulted from one another to allow for the generation of three discreet signals. This can allow for the determination of three discreet navigational axis relative to the instrument <NUM>' as disclosed in <CIT>. In allowing for the generation of three discreet signals, three discreet navigational axes are determined for each of the different angles of the windings relative to the long axis <NUM>' of the instrument <NUM>'. This can allow for the determination of a plurality of degrees of freedom due to tracking the three discreet angles or three discreet portions at a different orientations relative to the long axis <NUM>' of the instrument <NUM>'. It will be understood that any appropriate number of discreet angle portions can be made relative to the instrument <NUM>' and three is merely exemplarily.

In addition or alternatively to having the wire wrapped to form a plurality, such as three angles, as illustrated in <FIG>, a plurality of different angles can be formed by rotating the navigation vectors relative to the long axis <NUM>", as illustrated in <FIG>. The long axis <NUM>" is defined by an instrument <NUM>", which can be the same or different than the instruments discussed above. The instrument <NUM>" can include one or more guide posts 140a, 140b, and 140c spaced apart axially along the length of the instrument <NUM>". Additionally, each of the guide posts is rotated around the long axis <NUM>" of the instrument, as further illustrated in <FIG>. Angles between each the guide posts 140a, 140b, 140c can be an appropriate angle, such as about <NUM>-<NUM> degrees, including about <NUM> degrees to about <NUM> degrees, and further including about <NUM> degrees (as exemplary illustrated by the one angle PA).

With reference to <FIG>, the instrument <NUM>", can include at least three tracking devices or portions 110a, 110b, and 110c. Each of the tracking devices 110a, 110b, and 110c positioned on the instrument <NUM>" can include or define a navigation vector 160a, 160b, and 160c. Therefore, the first navigation vector 160a can be formed by a first tracking device 110a, the second navigation vector 160b can be formed by the second tracking device 110b, and the third navigation vector 160c can be formed by the third tracking device 110c relative to the instrument <NUM>". Each of the navigation vectors 160a, 160b, and 160c can be formed relative to the instrument <NUM>" due to the positioning of the windings of material of the respective tracking devices 110a, 110b, and 110c at the winding angle relative to the instrument <NUM>".

<FIG> attempts to illustrate on a two-dimensional plane of a page a three-dimensional rotation of angles of the three different windings of the wire 110a, <NUM>0b, and 110c. As discussed above, in relation to <FIG>, each of the windings can be wound at the winding angle relative to the long axis <NUM>' of the instrument <NUM>'. As illustrated in <FIG>, however, rather than having the windings formed at various and different winding angles relative to the long axis <NUM>" of the instrument <NUM>", each of the windings 110a, <NUM>0b, and 110c can be formed at substantially a single winding angle, including those winding angles discussed above and such as about <NUM> degrees to about <NUM> degrees, relative to the long axis <NUM>" of the instrument <NUM>".

Because each of the coils of the tracking device windings 110a, <NUM>0b, and 110c are at the same winding angle, to resolve the six degrees of freedom of location a top or high point Ha, Hb, Hc of each of the coil windings 110a, 110b, and 110c are rotated rotation angles RA<NUM>, RA<NUM>, and RA<NUM>, such as about <NUM> degrees relative to one another, around the long axis <NUM>" of the instrument <NUM>". As discussed above, however, three windings are not required and an appropriate number of windings (e.g. only two windings 140a and 140b) can be used with an appropriate number of localizer coils. The rotation angles RA1, RA2, and RA3, can be selected to be <NUM> degrees to place each of the tops Ha, Hb, Hc substantially equidistant apart around the long and central axis <NUM>" of the instrument <NUM>". It will be understood, however, that the rotation angles RA<NUM>, RA<NUM>, and RA<NUM> can be about <NUM> degrees to about <NUM> degrees, including about <NUM> degrees. The at different rotation angles a distance about the long axis <NUM>" between each of the vectors 160a-160c and/or the posts 140a-140c will also vary.

As illustrated in <FIG>, the front or top end of the windings Ha-Hc are all in substantially the same direction, such as towards a distal end of the instrument <NUM>". Each of the windings 110a-110c are, thus, rotationally spaced apart around the center long axis <NUM>" of the instrument <NUM>". In this way, the navigation vectors 160a-160c for each of the windings 110a-110c can be formed at the same winding angle relative to the long axis <NUM>" of the instrument <NUM>". The navigation vectors 160a-160c are also, due to the rotational spacing of the coil windings tops Ha-Hc, rotationally spaced around the long axis <NUM>".

The different navigation vectors 160a-160c are defined relative to a center <NUM> of the instrument <NUM>". Each of the vectors 160a-160c can point towards a plane P, as illustrated in <FIG>, which is the plane of the page in <FIG>. The tails of the vectors 160a-160c can go into and past the plane on the page, thus all of the navigation vectors 160a-160c are not coplanar, but they all intersect the single plane P. Each of the vectors 160a-160c can be formed relative to the plane P rotationally spaced at the rotation angles relative to one another around the center <NUM> of the instrument <NUM>".

As discussed above, the navigation vector angle can be selected by forming the windings of the tracking device 110a-110c at a selected angle relative to the long axis of the coil winding 110a-110c which can also be the long axis of the instrument <NUM>". By changing the positioning of the angle of the rotation of the windings of the various tracking devices, the navigation vectors can be positioned relative to the instrument <NUM>" in this selected manner. In various embodiments, the vectors 160a-160c are differently oriented relative to the instrument <NUM>" by having more than one coil wound at the same winding angle, but being spaced relative to one another with the rotation angles.

The guide posts 140a-140c can be similar to those discussed above, but spaced axially along the axis <NUM>" of the instrument <NUM>". Thus, each of the guide posts can include top walls 117a-117c and angled walls or guide walls 156a-156c. Each of the angled walls can have the same angle as each of the coils 110a-110c can have the same angle. However, the guide posts 140a-140c positioned at varying rotational positions around the long axis <NUM>" allows for the formation of different navigation vectors 160a-160c relative to the long axis <NUM>" of the instrument <NUM>".

Also, each of the coil portions 110a, 110b, 110c can be formed on separate members and interconnected for a use. For example, each of the coils could be formed on separated hollow members are that can be placed over the instrument <NUM>" or over another hollow member. Each of the member can include an index finger and an index groove to ensure that the respective navigation vectors 160a-160c would be defined at the selected angle relative to one another. Thus, each of the coils 110a, <NUM>0b, and 110c need not be formed on the same or rigid member.

With reference to <FIG>, the instrument, according to various embodiments is illustrated as an instrument <NUM>. Instrument <NUM> can extend along a long axis <NUM> and define an internal cannula or bore <NUM>. Accordingly, the instrument <NUM> can include an external wall <NUM> which can be inserted into a subject, such as the patient <NUM>. The instrument <NUM> can be a guide tube or other guide instrument through which a second instrument, such as a drill bit or needle, is passed and guided. Alternatively, or in addition thereto, it will be understood that the instrument <NUM> may be solid, hollow, or cannulated and exemplarily be a drill bit, a probe, or other appropriate instrument. Accordingly, the exemplarily instrument <NUM> is merely for illustration for the current discussion.

The instrument <NUM> can include the tracking device <NUM> associated with the instrument <NUM>. The tracking device <NUM> can include various portions that are operable in the navigation system <NUM> to allow for the determination of a location (including position and orientation) of the instrument <NUM>. Generally, location information can include X, Y and/or Z dimensional coordinates along with at least two orientation coordinates (and when <NUM> degrees of freedom are determined at least three orientation coordinates). As discussed above, two separate coils can be used to solve for six degrees of freedom location information.

The tracking device <NUM> can be selected to include three sets of coils, although more or fewer coils can be selected based on the amount of location information selected. Each set of coils or coil can include a plurality of windings of a wire that can generate or be used to determine a navigation vector separate from the other coils or windings of wire. Accordingly, the navigation or tracking device <NUM> can include a first coil of wire <NUM> wound around a surface of the outer wall <NUM> or embedded in the surface of the outer wall <NUM> of the instrument <NUM>. The wire of the coil <NUM> is generally insulated both from adjacent turns of the wire and from the instrument <NUM>. Generally, the first coil <NUM> is wound around the long axis <NUM> and substantially coaxial therewith. Accordingly, the first coil <NUM> can define a navigation vector that generally aligned with the long axis <NUM> of the instrument <NUM>. It will be understood, however, that the first winding need not be coaxial with the long axis <NUM>.

A second coil set can include coil portions 208a and 208b. The coil portions 208a, b generally includes two coils that can be formed of a wire wound in a selected shape, such as an oval, circle, or ellipses, around a winding axis. The wire can be generally flat wire or a wire that has a round cross-section. As illustrated, the wire is wound in an oval having a long or major radius <NUM> generally along or aligned with the long axis <NUM> of the instrument <NUM>, wherein the major radius <NUM> extends from a focus of the respective coil portion 208a,b to an edge of the respective coil portion 208a,b. The coil portion 208a also has a short or minor radius <NUM> generally perpendicular from the long radius <NUM> of the respective coil portions 208a or 208b, wherein the minor radius <NUM> also extends from the focus of the respective coil portion 208a,b towards an edge thereof. The coil portions 208a and 208b can be connected in series and positioned about <NUM> degrees from one another around the surface of the outer wall <NUM> of the instrument <NUM> and around the long axis <NUM>.

Again, the coil portions 208a and 208b are generally positioned on the outer wall <NUM> or positioned at or in a holding region, for example in a depression in the outer wall <NUM> of the instrument <NUM>. The depression can hold the coil portions 208a, 208b alone (e.g. with an interference fit) and/or they can be adhered within the depression. For example, the depressions can be filled with a selected epoxy or adhesive to hold the coil portions 208a, b in place.

Accordingly, both of the coil portions 208a and 208b work as a single coil to increase the electromagnetic (EM) signal from the respective coil portions 208a and 208b. It will be understood, as discussed above, that the coil portions 208a and 208b can either receive or transmit an electromagnetic field to generate the EM signal. Additionally, the coil portions 208a and 208b can be wound around a core. The core can includes an EM permeable core material or be formed around an air core, as selected, for signal strength. Further, the coil portions 208a,b can be formed of a plurality of turns of insulated wire.

A third coil <NUM> can be formed as a first coil portion 220a and a second coil portion 220b (not illustrated) positioned substantially <NUM> degrees from the first coil portion 220a around the long axis <NUM> of the instrument <NUM>. Again, each of the coil portions 220a and 220b can be formed by winding a wire in a selected shape around a winding axis, such as an oval including a long radius <NUM> generally aligned with the long axis <NUM> of the instrument <NUM> and a short radius <NUM> that is generally perpendicular to the long radius <NUM> of the coil portion 220a. Further, each of the coil portions 220a and 220b can be positioned on a surface or in a depression formed in the surface of the outer wall <NUM> of the instrument <NUM>. Further, the two coil portions 220a and 220b can be connected in series similar to the coil portions 208a and 208b to increase the EM signal or sensitivity and reduce relative size per total number of windings relative to the instrument <NUM>. Further, the coil portions 220a,b can be formed of a plurality of turns of insulated wire.

Each of the coil portions 208a, 208b, 220a, and 220b can be positioned at a selected angle <NUM> from one another around the long axis <NUM> of the instrument <NUM>. As illustrated in <FIG>, the angle <NUM> can be a <NUM> degree angle formed between the coil portions 208a, 208b, 220a, and 220b and is defined as an angle <NUM> formed by two lines <NUM> and <NUM> that intersect at the long axis <NUM> of the instrument <NUM> and extend through the centers of two adjacent of the coil portions, such as 208a and 220a. The lines <NUM> and <NUM> can also be defined as extending perpendicular from a plan defined by an outside of the respective coil portions 202a,b and 220a,b that intersects the axis <NUM>. The <NUM> degree angle is an angle <NUM> formed between the two lines <NUM> and <NUM>. Accordingly, each of the coil portions 208a, b and 220a, b can be positioned around the long axis <NUM> of the instrument <NUM>.

Further, the navigational vectors of the respective coil portions <NUM> and <NUM> will generally be along the respective lines <NUM> and <NUM>. Accordingly, these two navigational vectors are generally <NUM> degrees relative to one another and are at different angles relative to the navigational vector that would generally be along the long axis <NUM> formed by the first coil <NUM> and near the first coil <NUM>. It will be understood, however, that the navigation vectors from the coil portions <NUM> and <NUM> can be positioned relative to the instrument <NUM> by changing the angle <NUM> to be a angular offset of the respective coil segments (e.g. more or less than <NUM> degrees) and by angling the surface of the windings of the respective coil portions <NUM> and <NUM> relative to the long axis <NUM> of the instrument <NUM>.

In one example, the coil portions <NUM> and <NUM> can have an end nearer the distal end <NUM> positioned a distance further from the axis <NUM> than an end further from the distal end <NUM>, as exemplarily illustrated in phantom coil 208a'. Although, the coil portions <NUM> and <NUM> can be angled in any appropriate manner to generate a selected navigation vector relative to the instrument <NUM>. Accordingly, the line <NUM> can be formed to be substantially not perpendicular to the long axis <NUM> of the instrument <NUM> to change the navigational vector of the coil portions <NUM>. By altering the navigational vector in such a manner, the respective navigation vectors can be used to identify different positions of the respective coil segments relative to the instrument <NUM> for different or increased navigational accuracy.

Moreover, it will be understood that a greater number of coil portions can be positioned on the instrument <NUM>. For example, additional oval coil portions can be positioned at different angles relative to the instrument <NUM>, such as about <NUM> degrees relative to the illustrated coil portions, at a position further from the distal end <NUM>. These additional coil portions can generate additional navigational vectors relative to the instrument <NUM> for increased navigational accuracy. The additional coil portions can be used for backup, error detection, location verification, and other appropriate reasons. All of the coil sets can act independently for navigation vector determination. Also, it will be understood, that the coil portions need not be at <NUM> degrees relative to one another.

With reference to <FIG> and <FIG>, an instrument <NUM> according to various embodiments is illustrated. The instrument <NUM> can be similar to the instruments discussed above, such as a stylet, a guide tube, a drill bit, or other appropriate instrument to be moved relative to a subject, such as the patient <NUM>. The instrument <NUM> can include the tracking device <NUM> which includes a plurality of tracking elements <NUM>, <NUM>, and <NUM>. Each of the respective tracking elements <NUM>, <NUM>, and <NUM>, can be positioned along a long axis <NUM> of the instrument <NUM>. It will be understood, as discussed above, that more or less than three tracking elements can be provided with the instrument <NUM>.

According to various embodiments, the tracking elements <NUM>, <NUM>, and <NUM> can be embedded or positioned within a holding portion, such as one or more recesses <NUM> formed in the instrument <NUM>. The elements <NUM>, <NUM> and <NUM> can be positioned in the recesses <NUM> such as by molding, machining the recess <NUM> and affixing the navigation portions within the recess <NUM>, or any other appropriate configuration. The shape of the tracking elements <NUM>, <NUM>, and <NUM>, as discussed herein, can include flat or planar portions that can be keyed or fit with an interference fit with the holding portion or each of the recesses <NUM>. In addition, or alternatively to the keyed fit, the tracking elements <NUM>, <NUM>, and <NUM> can be affixed within the recesses <NUM> with an adhesive, such as an epoxy, to fix the tracking elements <NUM>, <NUM>, and <NUM> relative to the instrument <NUM>.

Each of the three tracking elements <NUM>, <NUM>, and <NUM> can be formed or provided as a coil of wire wrapped around a selected core <NUM>. The core <NUM> can be a highly magnetically permeable core or an air core to form each of the respective tracking elements <NUM>-<NUM>. Generally, each of the tracking elements, such as the tracking element <NUM> illustrated in <FIG>, is wrapped around the core <NUM> and will define a navigation vector or axis <NUM> that is generally aligned with an axis about which the tracking elements <NUM> or, the respective other tracking elements, is wrapped.

Generally the tracking element <NUM>, or any other appropriate tracking elements, are barrel-wrapped around the core <NUM> such that the coil is wide near a central portion <NUM> and tapered towards the respective ends <NUM> and <NUM> of the respective tracking elements <NUM>-<NUM>. The end surfaces at the respective ends <NUM> and <NUM> can generally be flat to be keyed or have an interference fit within the holding portion recesses <NUM>. Also, the shape of the windings of the tracking elements <NUM>-<NUM> can generally be defined by the core <NUM>, especially if the core <NUM> is a shaped material. Thus, the winding is generally around the navigation axis <NUM>.

As specifically illustrated in <FIG>, the coil winding wraps around the core <NUM> of the tracking element <NUM> to be small on the first end <NUM> wider in the center <NUM> and taper again to a smaller end <NUM>. Accordingly the tracking element <NUM> can generally or roughly define a barrel shape to be positioned within or on the instrument <NUM> in a selected or indexed manner. The barrel shape generally has flatter or flattened ends so that its orientation is maintained and can be selected relative to the instrument <NUM>. It will be understood that a core can be selected to include the barrel shape of the winding of the wire can form the barrel shape. It is also understood that a barrel shape is not necessary and other shapes can be selected. Also, a core shape can be selected to index or be fit fixedly within the recesses <NUM>.

The appropriate plurality of navigation vectors can provide the instrument <NUM> with a six degree of freedom tracking device <NUM> as each of the coil elements can be positioned such that their respective navigation vectors <NUM>, <NUM>, and <NUM>, are positioned substantially orthogonal relative to one another along the longitudinal length of the long axis <NUM> of the instrument <NUM>. Although, it is understood that three different vectors are not required to obtain the six degree of freedom information, as discussed above. By providing the plurality of navigational vectors or axes of winding of the tracking elements <NUM>-<NUM> (e.g. indexing or fixing the tracking elements <NUM>-<NUM> at different angles relative to the instrument <NUM>), a plurality of vectors can be identified for the instrument <NUM> using each of the individual tracking elements <NUM>-<NUM>. Accordingly, the instrument <NUM> can be navigated with substantially six degrees of freedom of location information determining location information of each of the respective tracking elements <NUM>-<NUM>. However, each of the coil elements need not be overlapping one another and can be positioned at any appropriate location within the instrument <NUM>.

Additionally, it will be understood, that each of the tracking elements <NUM>-<NUM> can be positioned at any appropriate location relative to the instrument <NUM> or any other appropriate instrument. Accordingly, having the plurality of tracking elements <NUM>-<NUM> as substantially next to one another, as illustrated in <FIG>, is not required and they can be spaced apart for various reasons. For example, communication lines, such as to an ablation electrode, may pass between the respective tracking elements <NUM>-<NUM> and the spacing may be altered for such considerations. However, knowing the location of the respective tracking elements <NUM>-<NUM> relative to each other and the instrument <NUM> allows for navigation of the instrument <NUM> with substantially six degrees of freedom with the navigation system <NUM>.

It will be understood that various instruments, especially the instruments <NUM>, <NUM>, and <NUM>, are illustrated herein for examples. However, a plurality of instruments can include all or individually the various tracking devices or portions thereof illustrated in particular embodiments. For example, as illustrated in <FIG>, an instrument <NUM>, according to various embodiments, can include one or more of each of the selected portions of the tracking device <NUM>. Accordingly, the tracking device <NUM> can include oval coil segments 208a and 208b connected in series on the instrument <NUM>. Additionally, an angled coil, such as the coil configuration <NUM> can be provided between guide posts <NUM>' on the instrument <NUM>. Additionally, a coil element, such as the coil element <NUM> can be provided within the instrument <NUM>. Each of the respective coil elements can include navigation vectors that are positioned at different angles relative to one another, such as substantially orthogonally or otherwise non-aligned. For example, the coil elements 208a, b can define a navigation vector <NUM> that can be perpendicular to a long axis <NUM> of the instrument <NUM>. The coil winding <NUM> can define a navigation vector <NUM> at a selected angle relative to the long axis <NUM>. Finally, the coil element <NUM> can define a third navigation vector <NUM> relative to the long axis <NUM> that can also be generally perpendicular, but in the opposite or different direction of the coil elements 208a, 208b or aligned with the long axis. Accordingly, each of the three coil portions or segments can be positioned on the instrument <NUM> where each have different configurations, as discussed above, while providing a plurality of navigation vectors relative to the instrument <NUM>. Accordingly, it will be understood that the instrument <NUM>, according to various embodiments, need not include a substantially consistent coil segment design and can be provided for different coil segment configurations.

It will be understood that the tracking device <NUM> can be positioned on an instrument that is substantially not rigid. For example, the instrument can be movable or bendable and have portions that rotate relative to other portions of the instrument. Also, the tracking device <NUM> can be positioned on a probe that can be angled and rotated relative to the patient <NUM>, or any appropriate subject. Accordingly, the rotational direction and orientation relative to the subject along with its three-dimensional position can be determined. Additionally, the tracking device <NUM> can be positioned on a substantially continuously rotating instrument, such as a drill bit, to be moved relative to the subject, such as the patient <NUM>, and the location and other position and orientation information can be determined in the navigation system <NUM>. Accordingly, providing the tracking device <NUM> and a guide tube or probe or substantially slow-moving instrument is not required, and the tracking device <NUM> can be placed on any appropriate instrument for navigation in the navigation system <NUM>. For example, the elements of the tracking device <NUM> can be assembled and the tracking device assembly can be attached to a handle of the instrument <NUM>, <NUM>, <NUM> and <NUM>.

The tracking devices, according to any embodiments discussed above, can be provided directly on instruments as illustrated above. It will be understood, however, that the tracking devices can be provided on other portions or members that can be interconnected or attached to any appropriate instrument. For example, as illustrated in <FIG>, the tracking device <NUM> can be connected with a stem or pedestal to instrument to track the instrument. Accordingly the tracking device can be positioned on an instrument that is not originally formed with instrument so that the instrument can include the tracking device.

Additionally, the tracking devices can be provided to minimize or maintain an outer diameter or perimeter of the instrument. Although the cross section of the instrument can be provided in any selected shape (e.g. round, square, oval), the tracking devices can be provided to minimize an increase in an outer perimeter dimension, such as a diameter, due to the positioning of a tracking device on the instrument. For example, the tracking device including the coil <NUM>, as illustrated in <FIG> with the instrument <NUM>, can be wrapped around the instrument to be substantially maintained within an outer diameter of the instrument <NUM>. As illustrated in <FIG>, coil portions <NUM> and <NUM> can be positioned within depressions in the instrument <NUM> to assist in substantially maintaining an outer diameter of the instrument <NUM>. In addition, these coil segments <NUM> and <NUM> can be made relatively flat (e.g. having a height of less than about <NUM>, including about <NUM> to about <NUM>) relative to the instrument <NUM> to assist in maintaining an outer diameter of the instrument <NUM> after positioning the coil segments relative to the instrument <NUM>. Further, the tracking device portions <NUM>, <NUM>, and <NUM> illustrated in <FIG> can be positioned on the instrument <NUM> substantially within an outer diameter of the instrument <NUM>. In particular, the tracking portions can be embedded within an outer diameter of instrument <NUM> to maintain the size of the instrument <NUM> for various purposes. Accordingly, the tracking devices, according to the various embodiments, can be connected with instruments to assist in maintaining a dimension of the instrument for purposes of assisting in minimizing the size of instrument for surgical procedures. It will be also understood that the tracking devices can interconnected with other instruments to assist in tracking instruments for nonsurgical procedures, such as manufacturing, exploration, and other purposes.

Claim 1:
A navigation system (<NUM>), comprising:
an instrument (<NUM>) that is operable to be moved relative to a subject and having an exterior wall that defines an instrument axis (<NUM>);
a holding portion defined by the instrument substantially within a surface of the exterior wall; and
a tracking device formed of at least a first portion having a first conductive wire wound around a first core (<NUM>), wherein the first portion has the first core (<NUM>) that defines a shaped member having a first wider center portion and a pair of tapered ends, said wire being wrapped around the first wider central portion and the tapered ends,
wherein the first portion defines a first navigation vector,
wherein at least one of said pair of tapered ends has a generally flat surface,
characterized in that
the first portion is positioned in the holding portion of the instrument and wherein the holding portion includes a first depression (<NUM>) to receive the first portion, positioning the generally flat surface against a surface of the first depression.