Patent Publication Number: US-2021177527-A1

Title: Methods for surgical navigation

Description:
RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 15/934,165, filed Mar. 23, 2018, which claims the benefit of and priority to U.S. Provisional Application Ser. No. 62/488,192, filed Apr. 21, 2017, the contents of which are hereby incorporated by reference as if recited in full herein. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to medical systems and methods and, more particularly, to in vivo medical systems and methods. 
     BACKGROUND 
     Surgical navigation systems identify desired trajectories and paths to target tissue or anatomy during surgeries for introducing medical interventional devices into the body. See, U.S. Pat. Nos. 9,042,958 and 9,498,290, the contents of which are hereby incorporated by reference as if recited in full herein. 
     SUMMARY 
     Embodiments of the present invention provide methods, devices and systems which can employ a system with a trajectory guide assembly that can serially and interchangeably hold either or both a fluid-filled single lumen guide or a fluid-filled multi-lumen guide and one or more elongated device guides for localized placement and/or delivery of diagnostic or therapeutic devices or substances. 
     Embodiments of the present invention may be particularly suitable for introducing therapeutic medications using an intrabody cannula, placing neuro-modulation leads, such as Deep Brain Stimulation (“DBS”) leads, implantable parasympathetic or sympathetic nerve chain leads and/or CNS stimulation leads, as well as other devices within the brain. 
     Embodiments of the present invention may be suitable for a number of interventional procedures in many locations inside the body including, but not limited to, brain, cardiac, spinal, urethral, and the like. 
     Embodiments of the present invention may be suitable for a number of image guided drug delivery procedures to intra-brain or other intra-body targeted locations. 
     Embodiments of the present invention may be suitable for a number of image-guided tumor removal procedures. 
     Embodiments of the present invention are directed to surgical navigation systems that include a trajectory guide assembly with a base having a patient access aperture formed therein. The base is configured to be secured to the body of a patient; a yoke movably mounted to the base and rotatable about a first axis. The assembly also includes a platform with an open port that is movably mounted to the yoke and rotatable about a second axis. The system also includes a trajectory selection guide member comprising at least one longitudinally extending fluid filled channel of one or more contrast agents releasably attachable to the platform; and a multi-lumen device guide comprising a plurality of longitudinally extending open channels releasably attachable to the platform. The trajectory selection guide member and the multi-lumen device guide are serially interchangeably held by the platform and each have a length sufficient to extend through the port of the platform with a bottom portion thereof residing a distance below the platform. 
     The system can include an image processing circuit configured to generate and display a virtual trajectory selection guide member configured as a virtual multi-lumen guide array and aligned with an image of the trajectory guide assembly. The virtual multi-lumen guide array can include a plurality of radially and/or circumferentially spaced apart virtual channels spaced apart about a virtual center channel in a pattern corresponding to positions of the open channels of the multi-lumen device guide. The virtual center channel can be aligned with a center of the open port of the platform. 
     The platform can include visual orientation indicia on an upper surface thereof that includes a patient right directional indicator, a patient left directional indicator and a forward directional indicator. 
     The trajectory selection guide member can be a multi-lumen guide array with a plurality of radially and/or circumferentially spaced apart fluid filled lumens spaced apart about a center fluid filled lumen. The trajectory selection guide member can have an upper surface with visual orientation indicia including a patient right directional indicator, a patient left directional indicator and a forward directional indicator. 
     The trajectory selection guide member can have a cap sealably attached to and enclosing a primary body. The cap can reside above a liquid reservoir. The liquid reservoir can have a width that is larger than a width of the at least one longitudinally extending fluid filled lumen and merges into the at least one longitudinally extending fluid filled channel. 
     The platform can be rectangular. The system can also include a tubular support member held by the platform that extends under the open port. The open port of the platform can have a perimeter with an alignment feature that circumferentially extends about a sub-set of the perimeter and that slidably receives a matable alignment feature on the multi-lumen device guide. 
     The system can further include at least one drill bit guide that is also releasably and interchangeably extended through the port of the platform and is directly secured to the platform. The at least one drill bit guide can be one or more of: a rotatable offset guide with a longitudinally extending channel that is offset from an axially extending centerline of the guide; a center guide with a longitudinally extending channel that is centered with an axially extending centerline of the guide; and a rotatable combination guide with a center longitudinally extending channel that is aligned with an axially extending centerline of the guide and a radially offset longitudinally extending channel. 
     The trajectory selection guide member can be a multi-lumen guide array that comprises a plurality of radially and/or circumferentially spaced apart fluid filled lumens spaced apart about a center fluid filled lumen. The multi-lumen guide array and the multi-lumen device guide can have the same number of channels in the same array configuration. 
     The virtual multi-lumen guide array and the multi-lumen device guide can have the same number of channels in a common array configuration. 
     The trajectory selection guide member can be a multi-lumen guide array with a plurality of radially and/or circumferentially spaced apart fluid filled lumens. The fluid filled channels of the multi-lumen guide array terminate at a top end under a cap. The multi-lumen device guide can have a top end that is at the same height as the top end of the fluid filled channels. 
     The trajectory guide assembly can include a pair of arcuate laterally spaced apart arms that hold the platform therebetween and above the base and only two actuators for pitch and roll. 
     The trajectory guide assembly can be devoid of x-y direction actuators. 
     The platform can be slidably supported by the arms to thereby allow the mount to slidably travel forward and rearward over a curvilinear path defined by the arms. 
     The plurality of fluid filled channels can have a common length. 
     The trajectory selection guide member can be a multi-lumen guide array with a plurality of radially and/or circumferentially spaced apart fluid filled lumens spaced apart about a center fluid filled lumen. 
     The plurality of fluid filled channels of the multi-lumen guide array and the plurality of open channels of the device guide can be seven. 
     The trajectory selection guide member can be a multi-lumen guide array with a plurality of spaced apart longitudinally extending fluid filled lumens. The plurality of longitudinally extending fluid filled channels can include a center channel with adjacent channels residing spaced apart about the center channel. The multi-lumen guide array can include orientation indicia corresponding to patient directions of right, left and forward. The platform can have corresponding orientation indicia. 
     Yet other embodiments are directed to surgical navigation systems that include a trajectory guide assembly comprising: a base having a patient access aperture formed therein. The base is configured to be secured to the body of a patient. The assembly also includes a yoke movably mounted to the base and rotatable about an axis; and a platform with an open port that is movably mounted to the yoke and rotatable about an axis. The systems also include a trajectory selection guide comprising at least one longitudinally extending fluid filled channel of one or more contrast agents releasably attachable to the platform; and a multi-lumen device guide comprising a plurality of longitudinally extending open channels releasably attachable to the platform. The trajectory selection guide and the multi-lumen device guide are serially interchangeably held by the platform to extend through the port of the platform with a segment thereof residing a distance below the platform. 
     The system can further include an image processing circuit configured to generate and display a virtual trajectory selection guide member configured as a virtual multi-lumen guide array and aligned with an image of the trajectory guide assembly. The virtual multi-lumen guide array can include a plurality of radially and/or circumferentially spaced apart virtual channels spaced apart about a virtual center channel in a pattern corresponding to positions of the open channels of the multi-lumen device guide. The virtual center channel can be aligned with a center of the open port of the platform. 
     The system can further include at least one drill bit guide that is also releasably and interchangeably extended through the port of the platform and is directly secured to the platform. The at least one drill bit guide can include at least one of: a rotatable offset guide with a longitudinally extending channel that is offset from an axially extending centerline of the guide; a center guide with a longitudinally extending channel that is centered with an axially extending centerline of the guide; and a rotatable combination guide with a center longitudinally extending channel that is aligned with an axially extending centerline of the guide and a radially offset longitudinally extending channel. 
     The platform can include directional orientation indicia on an upper surface thereof, wherein the trajectory guide assembly further comprises a pair of arcuate laterally spaced apart arms that hold the platform therebetween and above the base and only two actuators for pitch and roll. The trajectory guide assembly can be devoid of x-y direction actuators. 
     The virtual multi-lumen guide array and the multi-lumen device guide can have the same number of lumens in a common array configuration. 
     The trajectory selection guide is a multi-lumen guide array that comprises a plurality of radially and/or circumferentially spaced apart fluid filled lumens spaced apart about a center fluid filled lumen, and wherein the multi-lumen guide array and the multi-lumen device guide have the same number of channels in a common array configuration. 
     The trajectory selection guide member can be a multi-lumen guide array that has a plurality of spaced apart longitudinally extending fluid filled lumens. The fluid filled channels of the multi-lumen guide array can terminate at a top end under a cap. The multi-lumen device guide can have a top end that is at the same height as the top end of the fluid filled channels. 
     The plurality of longitudinally extending fluid filled channels can have a common length. 
     The plurality of fluid filled channels in the multi-lumen guide array and the plurality of open channels in the multi-lumen device guide can be seven 
     The plurality of longitudinally extending fluid filled channels can have a center channel and adjacently positioned channels residing spaced apart about the center channel. 
     The multi-lumen device guide array can have orientation indicia corresponding to patient directions of right, left and forward and the platform can have corresponding orientation indicia. 
     Other embodiments are directed to methods of introducing a device(s) into a subject. The methods include: placing a trajectory frame on a subject, the trajectory frame comprising a base, a yoke attached to the base and a platform attached to the yoke, the platform comprising an open port; inserting a trajectory guide with a single longitudinally extending fluid-filled lumen or a multi-lumen guide array with a plurality of longitudinally extending fluid filled channels through the port and securing the trajectory guide or the guide array directly to the platform; identifying a desired trajectory; removing the trajectory guide or the multi-lumen guide array from the platform; inserting a device guide with multiple open longitudinally extending through channels into the port and securing the device guide to the platform; and introducing at least one device into a channel of the open channels of the device guide and into a body of a subject. 
     The methods can also include: electronically generating a virtual multi-lumen guide array with a plurality of longitudinally extending parallel virtual channels; electronically aligning the generated virtual multi-lumen guide array with an image of the trajectory frame; and displaying an image with the virtual multi-lumen guide array overlaid on the trajectory frame with the virtual. The virtual multi-lumen guide array can include a plurality of radially and/or circumferentially spaced apart virtual channels spaced apart about a virtual center channel in a pattern corresponding to positions of the open channels of the multi-lumen device guide. 
     The electronically aligning can be carried out by identifying orientation features of the trajectory guide on the subject in Mill image data and aligning the virtual center channel with a center of the open port of the platform. 
     According to some embodiments of the present invention, system has a base, a yoke movably mounted to the base and that is rotatable about a roll axis, and a platform movably mounted to the yoke and that is rotatable about a pitch axis. The platform includes a port that can releasably and interchangeably hold a tubular single or multi-lumen fluid filled guide array member and at least one tubular device guide comprising a plurality of longitudinally extending open lumens. The base has a patient access aperture formed therein and is configured to be secured to the body of a patient such that the aperture overlies an opening in the body. 
     A roll actuator can be operably connected to the yoke and is configured to rotate the yoke about the roll axis. A pitch actuator can be operably connected to the platform and is configured to rotate the platform about the pitch axis. 
     The base may include a plurality of locations for attachment to a body of a patient via fasteners. In some embodiments, one or more attachment locations may include multiple adjacent apertures configured to receive a fastener therethrough. For embodiments where the frame is configured to be attached to the skull of a patient, the base can be configured to be secured to the skull of a patient such that the patient access aperture overlies a burr hole formed in the patient skull. 
     According to some embodiments of the present invention, the yoke includes a pair of spaced apart arcuate arms. The platform directly supports the multi-lumen guide array and the multi-lumen device guide and moves along the yoke arcuate arms when rotated about the pitch axis. 
     The base can include at least one arcuate arm. The yoke engages and moves along the base arcuate arm when rotated about the roll axis. 
     In some embodiments, the actuators are color-coded such that each different actuator has a respective different color. This allows a user to quickly determine which actuator is the correct one for a particular desired movement of the frame. 
     The elongated tubular guide extends through the port in the platform and yoke along a Z-direction and includes opposite proximal and distal end portions. The device guide distal end portion is positioned proximate the patient access aperture. The device guide includes a bore therethrough that extends from the proximal end portion to the distal end portion, and the device guide can be configured to removably receive different devices within one or more open bores. The devices may have different sizes and configuration. Exemplary devices include a needle infusion cannula, a tracking device with an array of optical fiducials, a microelectrode drive, a catheter guide, etc. 
     The at least one tubular device guide can include a multi-lumen device guide with a plurality of parallel longitudinally extending open through-lumens. 
     In some embodiments of the present invention, the at least one device guide can have a proximal end portion which engages the platform over the port. For example, the device guide proximal end portion may include a detent, or other type of structure (shape and/or component), formed therein, for a quick-release attachment. 
     The device guide can include a portion having a protrusion configured to engage the detent so as to removably secure the device to the guide via a snap fit. Alternatively, the guide proximal end portion may include a protrusion and the device may include a portion having a detent formed therein that is configured to engage the protrusion so as to removably secure the device to the guide via a snap fit. 
     The term “quick release,” as used herein, means that a technician or other user can quickly (e.g., typically in under about 1 minute or under about 30 seconds) remove a device from the guide with little effort and without requiring tools. 
     According to some embodiments of the present invention, an interventional method includes affixing a frame with a cooperating single lumen or multi-lumen fluid filled array to the skull of a patient, identifying a desired trajectory, replacing the single lumen or multi-lumen fluid filled array with a device guide. 
     The method may be carried out in an operating room using a camera based tracking system. 
     The method may be carried out using images acquired from a CT scanner during the procedure and/or using MRI images. 
     In some embodiments, such as, for neuro, using both pre-acquired and real time acquired MRI brain images and CT images at one or times during the procedure). 
     The entire workflow of a patient procedure may be carried out entirely in an Mill suite or in an OR followed by an MRI suite. 
     It is noted that aspects of the invention described with respect to one embodiment may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any feature of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail below. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a side perspective view of an example stylus of a surgical navigation system that can be used to provide an entry into a patient. 
         FIG. 1B  is a schematic side perspective view of the example stylus shown in  FIG. 1A  used to pick an entry point into a skull of a patient. 
         FIG. 2A  is a side perspective view of an example centering screw guide that can directly anchor over a selected entry point on a patient, i.e., patient skull, for a twist point entry sequence, according to embodiments of the present invention. 
         FIG. 2B  is a top, side perspective view of a screw driver that can be used to secure the centering screw guide shown in  FIG. 2A  to a patient according to embodiments of the present invention. 
         FIG. 2C  is a top, side perspective view of the centering screw guide shown in  FIG. 2A  with the screw secured into the skull according to embodiments of the present invention. 
         FIG. 2D  is a top perspective view of a centering tool that can cooperate with the centering guide screw to help position a trajectory frame onto the patient according to embodiments of the present invention. 
         FIG. 2E  is a top perspective view of the centering tool shown in  FIG. 2D  concentrically positioned about and attached directly onto the centering screw guide according to embodiments of the present invention. 
         FIG. 2F  is a top perspective vie of the centering tool that can be directly placed into a divot formed by a burr hole entry (instead of a twist point entry and not requiring a centering guide screw) according to embodiments of the present invention. 
         FIG. 2G  is a side perspective view of the centering tool positioned so that a distal end thereof fits directly into the burr hole according to embodiments of the present invention. 
         FIG. 3A  is a side perspective view of an example trajectory frame base that can couple to a patient&#39;s skull or other target device or anatomy according to embodiments of the present invention. 
         FIG. 3B  is a side perspective view of the trajectory frame base aligned over the centering tool shown in  FIGS. 2D and 2G  according to embodiments of the present invention. 
         FIG. 3C  illustrates the trajectory frame base secured to the patient and the centering guide removed according to embodiments of the present invention. 
         FIGS. 4A and 4B  are side perspective views of an example trajectory frame that can be attached to the base shown in  FIG. 3A  according to embodiments of the present invention. 
         FIG. 4C  is a partially exploded view of the trajectory frame shown in  FIGS. 4A and 4B . 
         FIG. 4D  is a side perspective view of the trajectory frame aligned with the base according to embodiments of the present invention. 
         FIG. 4E  is a side perspective assembled view of the trajectory frame and base according to embodiments of the present invention. 
         FIG. 5A  a side perspective view of the trajectory frame and base and a navigation stylus adapter that is releasably held by the trajectory frame according to embodiments of the present invention. 
         FIG. 5B  is an assembled view of the navigation stylus adapter in the trajectory frame shown in  FIG. 5A . 
         FIG. 5C  is a top perspective view of a navigation stylus insertable into the adapter shown in  FIG. 5B  according to embodiments of the present invention. 
         FIG. 5D  is an assembled view of the components shown in  FIG. 5C . 
         FIG. 5E  is an enlarged side view of the assembled device shown in  FIG. 5C  illustrating a pitch adjustment actuator for pitch adjustments according to embodiments of the present invention. 
         FIG. 5F  is a side perspective view of the assembled device shown in  FIG. 5C  illustrating an example pitch adjusted orientation according to embodiments of the present invention. 
         FIG. 5G  is an enlarged side view of the assembled device shown in  FIG. 5C  illustrating a roll adjustment actuator for roll adjustments according to embodiments of the present invention. 
         FIG. 511  is a side perspective view of the assembled device shown in  FIG. 5C  illustrating an example roll-adjusted orientation according to embodiments of the present invention. 
         FIG. 6A  is a side perspective view of an example guide array with fluid filled lumens according to embodiments of the present invention. 
         FIG. 6B  is a top view of a primary body of the guide array shown in  FIG. 6A . 
         FIG. 6C  is a side partial exploded view of the guide array shown in  FIG. 6A . 
         FIG. 6D  is side perspective view of the guide array shown in  FIG. 6A  with internal fluid filled lumen channels shown partially transparent. 
         FIG. 7A  is a side perspective view of the guide array aligned with the trajectory frame for assembly thereto according to embodiments of the present invention. 
         FIG. 7B  is an enlarged side perspective view of the guide array in the platform of the trajectory guide according to embodiments of the present invention. 
         FIG. 7C  is a side perspective assembled view of the components shown in  FIG. 7A . 
         FIGS. 7D and 7E  are partial top views of the assembly shown in  FIG. 7C . 
         FIG. 8  is a side view of a fluid-filled guide array adjacent a multi-lumen guide according to embodiments of the present invention. 
         FIGS. 9A-9C  are top, side perspective views of example device guides according to embodiments of the present invention. 
         FIG. 10A  is a top, side perspective views of the device guide shown in  FIG. 9C  aligned with the trajectory frame according to embodiments of the present invention. 
         FIG. 10B  illustrates the device guide shown in  FIG. 10A  assembled to the trajectory frame. 
         FIGS. 10C and 10D  are top views of the assembly shown in  FIG. 10B  according to embodiments of the present invention. 
         FIG. 10E  is a top view of an example user interface providing rotational alignment feedback of a desired orientation of the guide channel to a user according to embodiments of the present invention. 
         FIG. 10F  is a partial side perspective view of a drill and drill bit cooperating with the device guide and trajectory frame assembly shown in  FIG. 10B  according to embodiments of the present invention. 
         FIG. 10G  is a side perspective view of the drill and drill bit shown in  FIG. 10F  prior to coupling to the device guide according to embodiments of the present invention. 
         FIG. 10H  is a top perspective view of the trajectory frame after the device guide shown in  FIG. 10B  is removed with a twist point entry hole made using the drill and drill bit shown in  FIG. 10G . 
         FIGS. 11A and 11B  are side perspective views of an example multi-lumen guide with open through channels according to embodiments of the present invention. 
         FIG. 11C  is a top view of the device shown in  FIGS. 11A and 11B  alongside a fluid-filled guide according to embodiments of the present invention. 
         FIG. 11D  is a top perspective view of the multi-lumen guide shown in  FIGS. 11A and 11B  aligned with the trajectory frame according to embodiments of the present invention. 
         FIG. 11E  is an assembled view of the components shown in  FIG. 11D . 
         FIG. 11F  is a side perspective view of an example therapeutic device aligned with the assembled components shown in  FIG. 11F  according to embodiments of the present invention. 
         FIG. 11G  illustrates the therapeutic device held by the multi-lumen guide and trajectory frame shown in  FIG. 11F . 
         FIGS. 12A and 12B  are partial side perspective assembled views of the assembled components shown in  FIG. 11E  and illustrating a single therapeutic device coupled thereto ( FIG. 12A ) and multiple therapeutic devices coupled thereto ( FIG. 12B ) according to embodiments of the present invention. 
         FIG. 13A  is an enlarged top perspective view of an exemplary grid that can be used to select an entry point according to embodiments of the present invention. 
         FIG. 13B  is a top, side perspective view of the grid shown in  FIG. 13A  used with a centering screw guide and screwdriver according to embodiments of the present invention. 
         FIG. 13C  illustrates the centering guide coupled to the grid according to embodiments of the present invention. 
         FIG. 13D  illustrates a bone screw coupled to the grid according to embodiments of the present invention. 
         FIG. 13E  illustrates an enlarged view of the bone screw in position with the grid removed according to embodiments of the present invention. 
         FIG. 14A  is an enlarged partial section view of an example targeting cannula according to embodiments of the present invention. 
         FIG. 14B  is a side perspective view of the targeting cannula shown in  FIG. 14A  aligned with the trajectory frame shown in  FIG. 4E  according to embodiments of the present invention. 
         FIGS. 14C and 14D  are side perspective assembled views of the components shown in  FIG. 14B . 
         FIGS. 14E and 14F  are side views illustrating example pitch adjustments using the targeting cannula and trajectory frame shown in  FIG. 14B . 
         FIGS. 14G and 14H  are side views illustrating example roll adjustments using the targeting cannula and trajectory frame shown in  FIG. 14B . 
         FIG. 15A  is a schematic illustration of a surgical navigation system that uses a virtual guide array according to embodiments of the present invention. 
         FIG. 15B  is a top view of a trajectory frame with a multi-lumen guide according to embodiments of the present invention. 
         FIG. 16  is a flow chart of exemplary actions that can be used for a medical procedure according to embodiments of the present invention. 
         FIG. 17  is a block diagram of a data processing system according to embodiments of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which some embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. 
     Like numbers refer to like elements throughout. In the figures, the thickness of certain lines, layers, components, elements or features may be exaggerated for clarity. The terms “Fig.” and “FIG.” may be used interchangeably with the word “Figure” as abbreviations thereof in the specification and drawings. 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising”, when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. 
     Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and/or clarity. 
     It will be understood that when an element is referred to as being “on”, “attached” to, “connected” to, “coupled” with, “contacting”, etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on”, “directly attached” to, “directly connected” to, “directly coupled” with or “directly contacting” another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature. 
     Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature&#39;s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of “over” and “under”. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise. 
     The term “about”, as used herein with respect to a value or number, means that the value or number can vary by +/− twenty percent (20%). 
     The term “MRI visible” means that a device is visible, directly or indirectly, in an MRI image. The visibility may be indicated by the increased SNR of the MRI signal proximate to the device (the device can act as an MRI receive antenna to collect signal from local tissue) and/or that the device actually generates MRI signal itself, such as via suitable hydro-based coatings and/or fluid (typically aqueous solutions) filled channels or lumens. 
     The term “MRI compatible” means that a device is safe for use in an MRI environment and/or can operate as intended in an MRI environment without generating MR signal artifacts, and, as such, if residing within the high-field strength region of the magnetic field, is typically made of a non-ferromagnetic MRI compatible material(s) suitable to reside and/or operate in a high magnetic field environment. 
     The term “high-magnetic field” refers to field strengths above about 0.5T (Tesla), typically above 1.0T, and more typically between about 1.5T and 10T. 
     The term “targeting cannula” refers to an elongate device, typically having a substantially tubular body that can be oriented to provide positional data relevant to a target treatment site and/or define a desired access path orientation or trajectory. At least portions of a targeting cannula contemplated by embodiments of the invention can be configured to be visible in an MRI image, thereby allowing a clinician to visualize the location and orientation of the targeting cannula in vivo relative to fiducial and/or internal tissue landscape features. 
     The term “cannula” refers to an elongate device that can be associated with a trajectory frame that attaches to a patient, but does not necessarily enter the body of a patient. 
     The term “imaging coils” refers to a device that is configured to operate as an MRI receive antenna. The term “coil” with respect to imaging coils is not limited to a coil shape but is used generically to refer to MRI antenna configurations, loopless, looped, etc., as are known to those of skill in the art. The term “fluid-filled” means that the component includes an amount of the fluid but does not require that the fluid totally, or even substantially, fill the component or a space associated with the component. The fluid may be an aqueous solution, MR contrast agent, CT contrast material or any material that generates a signal in the imaging modality used. 
     The term “two degrees of freedom” means that a trajectory frame described herein allows for at least translational (swivel or tilt) and rotational movement over a fixed site, which may be referred to as a Remote Center of Motion (RCM). 
     The terms “ACPC coordinate space” or “AC-PC orientation” refers to a right-handed coordinate system defined by anterior and posterior commissures (AC, PC) and Mid-Sagittal plane points, with positive directions corresponding to a patient&#39;s anatomical Right, Anterior and Head directions with origin at the mid-commissure point. 
     Embodiments of the present invention can be configured to guide and/or place diagnostic or interventional devices and/or therapies to any desired internal region of the body or object using MRI and/or in an MRI scanner or MRI interventional suite or using other image guided systems not requiring an MRI system or suite. 
     The object can be any object, and may be particularly suitable for animal and/or human subjects. Some embodiments can be sized and configured to place implantable DBS leads for brain stimulation, typically deep brain stimulation. Some embodiments can be configured to deliver tools or therapies that stimulate a desired region of the sympathetic nerve chain. Other uses inside or outside the brain include stem cell placement, gene therapy or drug delivery for treating physiological conditions. Some embodiments can be used to treat tumors. Some embodiments can be used for RF ablation, laser ablation, cryogenic ablation, etc. 
     In some embodiments, the trajectory frame and/or interventional tools can be configured to facilitate high resolution imaging via integral intrabody imaging coils (receive antennas), high intensity focused ultrasound (HIFU), and/or the interventional tools can be configured to stimulate local tissue, which can facilitate confirmation of proper location by generating a physiologic feedback (observed physical reaction or via fMRI). 
     Some embodiments can be used to deliver bions, stem cells or other target cells to site-specific regions in the body, such as neurological target sites and the like. In some embodiments, the systems deliver stem cells and/or other cardio-rebuilding cells or products into cardiac tissue, such as a heart wall via a minimally invasive image guided procedure, while the heart is beating (i.e., not requiring a non-beating heart with the patient on a heart-lung machine). Examples of known stimulation treatments and/or target body regions are described in U.S. Pat. Nos. 6,708,064; 6,438,423; 6,356,786; 6,526,318; 6,405,079; 6,167,311; 6539,263; 6,609,030 and 6,050,992, the contents of which are hereby incorporated by reference as if recited in full herein. 
     Generally stated, some embodiments of the invention are directed to interventional procedures and provide interventional tools and/or therapies that may be used to locally place interventional tools or therapies in vivo to site-specific regions using an image guided system. The interventional tools can be used to define a trajectory or access path to an in vivo treatment site. Some embodiments of the invention provide interventional tools that can provide positional data regarding location and orientation of a tool in 3-D space with a visual confirmation on an image. Embodiments of the invention may provide an integrated system or trajectory frames and components that can be used with one or more of commercially available conventional image guided systems that may allow physicians to place interventional devices/leads and/or therapies accurately. 
     Some embodiments configure devices so that they are compatible with several imaging modalities and/or image-guided systems. 
     For MRI uses, the systems may allow for shorter duration procedures over conventional systems (typically under six hours for DBS implantation procedures, such as between about 1-5 hours). 
     In some embodiments, a pre-operative image such as an MRI image can be used to visualize (and/or locate) a therapeutic region of interest inside the brain or other body locations. During surgery, the MRI or other pre-operative image can be used to visualize (and/or locate) an interventional tool or tools that will be used to deliver therapy and/or to place a chronically implanted device that will deliver therapy. 
     Embodiments of the invention provide devices and an operational sequence of a procedure that can be initiated in a first operating room then completed in a second operating room such as an MRI suite according to some embodiments of the present invention. 
     The same trajectory frame  100  can serially releasably hold a trajectory guide member that can have at least one elongate, longitudinally extending, fluid filled lumen, i.e., a single fluid filled lumen or may be configured as a multi-lumen fluid filled guide array, and interchangeable elongate device guides which can have one or multiple through/open lumens as will be discussed below. In some embodiments, an entire surgical procedure can be carried out in the Operating Room (OR) not requiring the use of an MRI suite using some of the devices shown. 
     In some embodiments, the three-dimensional data produced by a CT-guided and/or MRI-guided interventional system regarding the location of the therapeutic region of interest and the location of the interventional tool can allow the system and/or physician can make positional adjustments to the interventional tool so as to align the trajectory of the interventional tool with the region of interest, so that when inserted into the body, the interventional tool will intersect with the therapeutic region of interest. 
     In some embodiments, a camera based tracking system can be used. 
     The systems can have a hardware component(s) and a software component(s). In some embodiments, the hardware component includes a camera and workstation that can be used for many applications such as cranial, spine, orthopedic, ENT. There can be different software packages or modules for each system and/or for each application. 
     When the imaging system and/or the camera based image guided system confirms alignment is proper, the interventional tool aligned with the therapeutic region of interest, an interventional probe can be advanced, such as through an open lumen inside of the interventional tool, so that the interventional probe follows the trajectory of the interventional tool and proceeds to the therapeutic region of interest. It should be noted that the interventional tool and the interventional probe may be part of the same component or structure. A sheath may optionally form the interventional tool or be used with an interventional probe or tool. 
     In particular embodiments, using MRI in combination with local or internal imaging coils and/or MRI contrast material that may be contained at least partially in and/or on the interventional probe or sheath, the location of the interventional probe within the therapeutic region of interest can be visualized on a display or image and allow the physician to either confirm that the probe is properly placed for delivery of the therapy (and/or placement of the implantable device that will deliver the therapy) or determine that the probe is in the incorrect or a non-optimal location. Assuming that the interventional probe is in the proper desired location, the therapy can be delivered and/or the interventional probe can be removed and replaced with a permanently implanted therapeutic device at the same location. 
     Although described and illustrated herein with respect to the brain and the insertion of deep brain stimulation leads, it is understood that embodiments of the present invention may be utilized at other portions of the body and for various other types of procedures. 
     The image-guided system can be used for MRI and/or non-MRI image guided systems. 
     The trajectory frame and some or all of its cooperating components may be configured to be compatible for use in MRI and CT and/or camera based image guided systems.” To be clear, the term “image guided system” is used generally to refer to surgical navigation systems that include displays with patient images (which may be acquired before a surgery and/or at defined points during a surgery to confirm location) but does not require a continuous series of images from an imaging modality, such as a CT or MRI scanner, during the surgery. 
     In some embodiments, the system can include or work with a trajectory guide software module that can be an off-the-shelf module provided with conventional image guided systems that does not require any (or insignificant) modification. Examples of known commercial systems with trajectory guide software modules for camera based image guided systems that can be used with configurations of the trajectory frames and cooperating components include, for example systems from Brainlab, Inc., Stryker Medical and Medtronic Inc. 
     Referring to  FIGS. 1A and 1B , a navigation stylus  5  can be used to find a pre-planned trajectory and intrabody entry point, such as an entry point Se into a skull S of a patient. The stylus  5  is shown by way of example only and can have other shapes and configurations. The stylus  5  can be part of an OR navigation system used outside an MRI suite. There are two primary (or at least preferred) options for a surgeon to use to create an entry point Se into a brain through a skull. Option 1 is to use a twist point drill to create a small access hole typically in a range of about 2 mm to about 6.0 mm, such as about 3.4 mm, about 4.5 mm and about 6.0 mm. Option 2 is to create a larger burr hole such as a burr hole in a range of bout 10-mm to about 15 mm, such as about 14 mm. 
       FIGS. 2A-2E  illustrate the use of a centering screw guide  10  that can be directly attached to a patient at the selected entry point Se via a screw driver  15  for Option 1.  FIG. 2D  illustrates a centering tool  18  can be posited onto the centering screw guide  10 . The centering tool  18  can enter a base  110  that can support a trajectory frame  100  ( FIG. 4A ). The term “trajectory frame” is used interchangeably with “trajectory guide assembly.” The centering tool  18  can fit concentrically onto and over the centering screw guide  10  as shown in  FIG. 2E . 
       FIGS. 2F and 2G  illustrate that the centering tool  18  can fit directly into a burr hole Sb formed by Option  2 . The burr hole Sb can have a diameter in a range of about 10 mm-15 mm, such as about 14 mm, and can be formed through the skull based on a smaller divot made by the navigation stylus  5  ( FIG. 1A ). A distal end  18   d  of the centering tool  18  can fit directly into the burr hole Sb. 
       FIG. 3A  illustrates an example trajectory frame base  110  that can be used to anchor to the patient&#39;s skull. The base  110  can be a scalp mount base with a plurality of bone screws  113  and a plurality of stand-off pins  114 . This configuration uses a minimal incision over the entry point Se to create the access. Other trajectory frame bases can be used including, for example, a skull mount base which uses a larger incision and can mount directly to the skull but requires the scalp to be retracted for the direct skull attachment (not shown).  FIG. 3B  illustrates the base aligned with the centering tool  18  that is attached to the centering screw guide  10 . A distal end of the base  110  can have a port  112  that fits concentrically about the centering tool  18 . As shown in  FIG. 3C , once the base  110  is secured to the patient, the centering tool  18  can be removed (as well as the centering screw guide  10 , if used). 
     Referring to  FIGS. 4A-4E, 7A-12B , a trajectory frame  100  is shown. The upper portion  100   u  of the trajectory frame  100  can be attached to the base  110  after the base  110  is secured to the patient. The base  110  can be affixed to the trajectory frame  100  via fixation screws  122  ( FIG. 4D ). 
     Generally stated, the trajectory frame  100  may be configured to releasably and interchangeably (serially) hold different devices such as, for example, a fluid-filled single lumen guide  111  ( FIGS. 14A-14C ) which may also be referred to as a “targeting cannula” and/or a multi-lumen guide array  211  ( FIGS. 6A-6E ) and at least one device guide  311  ( FIG. 8 ). The guides  111  and  211  can also be referred to as a trajectory selection guide member. 
     Referring to  FIGS. 4A-4E , the trajectory frame  100  can include a tubular member  204 , such as a tower or column, that is held by the platform and that extends a distance below the platform  132 . The platform  132  can be planar and have an open port  132   p  that removably and interchangeably (serially) receives one or more of the single fluid-filled lumen guide  111  ( FIGS. 17A-17C ), the fluid-filled guide array  211  and one or more different device guides  311  ( FIGS. 11A-12B ) and optionally one or more drill guides  1311  ( FIG. 9 ) that have open lumens. The planar platform  132  can be rectangular and held by arcuate arms  101  of the trajectory frame  100 . The planar platform  132  can have orientation indicia  132   i  ( FIG. 7E ) on a top surface thereof. In some embodiments, the device guide  311  can have the same number and configuration of lumens as the fluid-filled guide array  211  ( FIGS. 8, 11C ). 
     The tubular member  204  can define a Z-direction along its longitudinal axis relative to the X-Y plane of the platform  132  (which does not include an X-Y table). 
     Referring to  FIGS. 4C and 4D , the yoke  120  is movably mounted to the base  110  and is rotatable about a roll axis. A roll actuator  140   b  is operably connected to the yoke  120  and is configured to rotate the yoke  120  about the roll axis. In some embodiments, the yoke  120  has a range of motion about the roll axis of about seventy degrees (70°). However, other ranges, greater and lesser than 70°, are possible, e.g., any suitable angle typically between about 10°-90°, 30°-90°, etc. The illustrated platform  132  is movably mounted to the yoke  120  and is rotatable about a pitch axis. A pitch actuator  140   a  is operably connected to the platform  132  and is configured to rotate the platform  130  about the pitch axis. In some embodiments, the platform  132  has a range of motion about the pitch axis of about seventy degrees (70°). However, other ranges, greater and lesser than 70°, are possible, e.g., any suitable angle typically between about 10°-90°, 30°-90°, etc. 
     The base  110  also includes a pair of spaced apart arcuate arms  116 , as illustrated in  FIG. 4D . The yoke  120  engages and moves along the base arcuate arms  116  when rotated about the roll axis. In the illustrated embodiment, one of the base arcuate arms  116  includes a thread pattern  118  formed in (e.g., embossed within, machined within, etc.) a surface  116   a  thereof. However, in other embodiments, both arms  116  may include respective thread patterns. 
     One or both actuators  140   a,    140   b  can include a rotatable worm gear (i.e., worm  121 ,  FIG. 4C ) with teeth that are configured to engage a thread pattern. As the worm gear is rotated, the teeth travel along the thread pattern in the arcuate arm surface. 
     Referring to  FIG. 4D , for example, the trajectory frame  100  includes a base  110 , a yoke  120  with the arcuate arms  101 , the platform  130 , and only two actuators  140   a - 140   b,  which are pitch and roll actuators. No x-y actuators are provided in this embodiment. The base  110  has a patient access aperture  112  formed therein, as illustrated. The base  110  is configured to be secured (directly or indirectly) to the skull of a patient such that the patient access aperture  112  overlies a burr hole in the patient skull. The patient access aperture  112  can be centered over the burr hole via the removable centering device  18  as discussed above ( FIG. 2D ). 
     Referring to  FIGS. 5A-5H , the trajectory frame  100  can releasably hold a navigation stylus adapter  25 . A fixation screw  133  in the platform  132  can tighten against the adapter  25 . The navigation stylus adapter  25  can secure the navigation stylus  5  such that it is concentrically aligned with the port  132   p  and used to make trajectory adjustments. The stylus  5  can be inserted into the stylus adapter  25  until it bottoms out inside the adapter  25  (i.e., it does not extend outside the bottom end of the adapter  25 ). A fixation screw  134  on an upper end portion of the adapter  5  can then be tightened against the stylus  5 . 
       FIGS. 5E and 5F  illustrate pitch adjustments (which can be clockwise or counterclockwise) via pitch actuator  140   a  and  FIGS. 5G and 5H  illustrate roll adjustments via roll actuator  140   b  (which can be clockwise or counterclockwise). 
     Referring to  FIGS. 4B, 5A and 5C , the stylus  5  can have a length L 1  ( FIG. 5C ) that is much greater than the length L 2  of the tubular (support) member  204  and the stylus adapter  25 . The tubular member  204  can have a length L 2  ( FIG. 4B ) that is greater than the length L 3  ( FIG. 5A ) of the stylus adapter  25 . L 1  can be 3×-20× greater than L 2 , in some embodiments, more typically 4×-8× greater. 
     Once the trajectory alignment is complete (the trajectory defined by the trajectory guide frame  100  and stylus  5  are approved by a surgeon), the patient can be moved from the OR to a surgical room which may be an Mill suite for further steps in a procedure/further treatment. 
     Referring to  FIGS. 6A-6E , after a trajectory is selected/set, a CT and/or MRI visible fluid filled guide  211  can be secured to the trajectory frame  100  (after stylus adapter  25 , where used, is removed) and be used to pick a path to the target. In some embodiments, the fluid-filled guide  211  can provide a plurality of selectable paths, each path associated with a straight linear and (MR visible) fluid filled lumen  211   f  defined by the guide array  211  to give a surgeon multiple options for selecting a safe path to the desired target. In other embodiments, the fluid filled guide can provide a single fluid filled lumen. The multiple paths can allow a surgeon to select a path from one of the plurality of paths associated with the lumens  211   f  to counter-act any mounting errors. The fluid-filled guide  211  can have a cap  211   c  threadably or otherwise sealably attached to the primary body  211   b  of the guide array. The cap  211   c  can include an O-ring  211   o  to prevent or inhibit leakage of fluid from the lumens  211   f,  once filled with an MRI and/or CT visible fluid. 
     As shown in  FIGS. 6D and 6E , there can be a plurality of closely spaced apart fluid filled lumens  211   f,  typically in a range of 4-10, shown as 7. Where multiple fluid filled lumens are provided, the guide  211  can be referred to as a “guide array.” The guide  211  can include channels as directional indicators  211   i,  shown as patient left DL (single), forward DF (single), patient right DR (dual). The directional indicator channels  211   i  can have a more shallow depth, shorter length and/or different (i.e., smaller or larger) cross-sectional size than the one or more fluid filled lumens  211   f.    
     As discussed above, the fluid filled guide  211  can have orientation indicia  211   i  as shown in  FIGS. 7D and 7E , shown with four spaced apart indicia with two orientation channels  211   i  being closer than the other two. The platform  132  can have visual orientation indicia  132   i  that corresponds to that of the guide  211   i,  shown as D L , DF and D R . The indicia  211   i,    132   i  can include two adjacent indicia for a patient right directional indicator, one for a patient left directional indicator and one for a forward directional indicator, for example. The orientation indicia  132   i  on the platform  132  can be painted, coated or otherwise provided with color-coded markings on an upper surface  132   u  of the platform  132  that can help a user to align the guide  211  and/or identify a channel and/or path selection. 
     Referring to  FIG. 7A , for example, the open port  132   p  can optionally be off center over the arcuate arms  101  to reside closer to one short side  132   s  of the platform  132  and can be centered side to side with respect to the long sides  132   l  of the platform. 
     Referring to  FIG. 7A , the platform  132  engages and moves along the yoke arcuate arms  101  when rotated about the pitch axis. In the illustrated embodiment, one of the yoke arcuate arms  101  includes a thread pattern  101   t  formed in (e.g., embossed within, machined within, etc.). However, in other embodiments, both arms  101  may include respective thread patterns. 
       FIGS. 7A-7E  show the guide  211  attached to the trajectory frame/guide  100 . The guide array  211  can be locked and secured to the trajectory frame via the fixation screw  133  of the platform  132  that was discussed above as used to secure the stylus adapter  25 . As shown in  FIGS. 7A and 7B , the guide  211  can have an external alignment feature  213  that engages a mating alignment feature  139  in the platform  132  of the trajectory frame  100  to facilitate correct orientation upon assembly. As shown, the alignment feature  213  is a projecting ledge while the mating feature is an enlarged perimeter segment of the port  132 . However, other affirmative alignment configurations may be used. 
     Referring to  FIG. 8 , the device guide  311  can have lumens  312  that are open channels and a height H that is less than that of the fluid filled guide  211 . The fluid filled lumens  211   f  can have a top  211   f   t  that is under a cap  211   c  (which can also be referred to as a bottom of a reservoir under the cap  211   c ) and can be at the same height dimension H as the top  311   t  of the multi-lumen device guide  311 . The fluid filled guide  211  can be used to identify and/or select a trajectory to the intrabody target. This same trajectory can be used for introducing a medical device ( 1000 ,  FIG. 11F ) using the device guide  311 , which replaces the multi-lumen guide array  211  held by the trajectory frame  100 . A line can be electronically drawn from the intrabody target up a desired trajectory along one of the fluid filled lumens  211   f  to the top of the fluid filled channel  211   f   t  of the fluid-filled guide array  211 . The distance between the intrabody target and a bottom of the reservoir/top of the fluid filled channel  211   f   t  can be a device insertion depth of a medical device  1000  ( FIG. 11F ). 
     Once the fluid-filled guide  211  is in position in the trajectory frame  100 , a clinician can perform an MRI scan that encompasses an image volume of the trajectory frame  100  and a desired intrabody target. The fluid filled guide channel(s)/lumen(s)  211   f  will be bright lines in an MRI image. A surgeon can select a fluid filled lumen  211   f  that most closely aligns or matches the desired insertion path. The clinician (i.e., surgeon) can electronically cause the surgical system to programmatically calculate and/or measure a device insertion depth using measurement software. That is, a line can be drawn from the target up the desired trajectory along a selected fluid filled lumen(s)  211   f,  to the bottom of the reservoir  211   r   b  and/or top of the fluid filled lumen  211   f   t . The distance between the target and the bottom of the reservoir  211   rb /top of the fluid filled lumen  211   f   t . can be used to calculate the device insertion depth. 
     If a user has opted to create a smaller entry hole with a twistpoint drill then a twist point entry sequence can be followed as shown in  FIGS. 10A-10H , followed by use of a device guide  311  with the longitudinally extending open through channels  312  (FIGS.  11 A- 11 E). If a burr hole entry was performed, there is no requirement for use of a twist point entry guide ( 1311 ,  FIGS. 9A-9C ) and a user can remove the fluid filled guide  211  and exchange it with the device guide  311  ( FIGS. 11A-11E ) which is then used to insert the medical device  1000  ( FIGS. 11F, 11G ). The user can perform the trajectory selection steps with the fluid-filled array  211  for a burr hole procedure, to pick a safe path to insert a device through the brain. This can be carried out before swapping the fluid-filled guide  211  with a device guide  311 . 
     Referring to  FIGS. 9A-9C , a device guide  1311  can be inserted into the tower of the trajectory guide  100 . The device guide  1311  is sized and configured to hold a drill bit  300  ( FIGS. 10F, 10G ) for a twist drill  310  ( FIGS. 10F, 10G ). Typically, the inner diameters of the channels  1312  can be about 3.4 mm, about 4.5 mm, about 6.0 mm and about 9.0 mm. The center guide  1311   c  may have a channel  1312  with a larger inner diameter. The rotatable combination guide  1311   c  can be configured with the first channel  1312   1  having a larger diameter than the second channel  1312   2 . The larger size channel can be the center channel. The first and second channels  1312 , can, in some embodiments include a 3.4 mm inner diameter channel and a 4.5 mm inner diameter channel. Other device guides can be used with other configurations to support drill bits or larger sized therapeutic devices. A multi-lumen device guide  311  suitable for smaller size devices is shown in  FIGS. 11A-11E . 
       FIG. 9A  illustrates a center guide  1311   c  with a longitudinally extending guide channel  1312  centered side to side (laterally), i.e., centered with a longitudinally extending/axially extending center line.  FIG. 9B  illustrates an offset device guide  1311   o  as the device guide  1311 . The offset device guide  1311   o  is a rotatable guide with a guide channel  1312  that is laterally offset from a longitudinally extending/axially extending center line.  FIG. 9C  illustrates a combination guide  1311   m,  that can include first and second guide channels  1312 , that are longitudinally extending and adjacent each other, one of which can be centered and one of which can be laterally offset from center. 
       FIG. 10A  is a top, side perspective views of the device guide  1311  (shown by way of example with device guide  1311   c ) aligned with the trajectory frame  100  according to embodiments of the present invention.  FIG. 10B  illustrates the device guide  1311  assembled to the trajectory frame  100  and rotationally locked into position using fixation member  133 . 
     Referring to  FIGS. 10A-10D , of a surgeon decides that an offset hole should be created, then the offset guide  1311   o  ( FIG. 9B ) or the combination guide  1311   m  (as shown) can be rotated and locked to a desired offset position to create the entry hole St (FIG.  1011 ). If no offset is needed, the center guide  1311   c  or the combination guide  1311   m  can be used. 
     As shown in  FIG. 10E , a surgical (navigation) system  1400  can include an image processing circuit  1600  in communication with a display  1610 . The image processing circuit  1600  can generate an image  1500  that aligns the trajectory frame  100  and device guide  1311  and visually illustrates a desired fluid filled channel  211   f  that is the one that should be used for alignment  211   fa . This alignment channel  2111   fa  can be highlighted, colored, darkened or otherwise visually distinguished from other fluid filled channels  211   f.  Thus, the image  1500  can include a virtual representation  1211  of the guide array  211  with the selected channel  211   f  previously identified for the selected trajectory visually distinguished. The guide  1311  can be rotated to align the guide channel  1312  with the visually distinguished channel  211   fa . The visually distinguished channel  211   fa  can be displayed in a first color different from one or other colors of other fluid filled lumens, or shown in black or white while the other fluid channels  211   f  are displayed in a different color or in black when the alignment channel  211   fa  is shown in white or in white when the alignment channel  211   fa  is shown in black. 
     The surgeon can use the image  1500 , typically an MRI image or a visualization, to display one or more fluid filled guide channel(s)  211   f  (virtually as the actual guide  211  is not on the trajectory frame  100  during this action) and directional channels  211   i  along with the alignment indicia  132   i  on the platform  321  to determine which direction to rotate and by how much. When the guide  1311  is rotated to an orientation that aligns one of the channels  1312  with a pre-selected trajectory associated with one of the one or more fluid filled lumens  211   f  of the fluid-filled guide  211 , the device guide  1311  can be locked into position using fixation member  133 . 
     Referring to  FIGS. 10C and 10D , the platform  132  can include straight outwardly extending lines  135  on an upper surface thereof that are circumferentially spaced apart and extend radially out from the port  132   p.  At least some (i.e., the longer lines) or each of the lines  135  can extend radially outward from a position of a respective fluid filled guide channel  211   f  that has a fixed rotational orientation in the platform  132 . The guide device  1311  can have a radially extending straight line  1313  that is aligned with a laterally extending centerline of the channel  1312 . This line  1313  can align with one of the lines  135  to help identify a fluid filled guide channel  211   f.  This line  1313  can align with one of the lines  135  to help position the device guide channel  1312  over the trajectory the user has previously selected from the fluid-filled array channel  211   f.    
       FIGS. 10F and 10G  show a drill  310  and drill bit  300  cooperating with the device guide  1311  and trajectory frame  100 . The drill bit  300  can be inserted into the guide channel  1312  of the device guide  1311  and the drill  310  can be actuated to form the entry hole St as shown in  FIG. 10H . 
       FIGS. 11A-11C  illustrate that a multi-lumen guide  311  with a plurality of spaced apart open through lumens/channels  312  can be coupled to the trajectory frame  100 . This guide  311  can be used to place/insert therapeutic devices  1000  into the patient to the target site. The multi-lumen guide  311  can have the same number of channels  312  as the fluid filled guide  211  and these channels  312  can be in the same position. As shown, there are seven channels  312 . 
     The guide  311  can have an external alignment feature  313  that cooperates with feature  139  in the platform  132  so that it the channels  311  have the same orientation as the channels  211   f  when attached to the platform. The alignment feature  313  can have the same shape as that of  213  of the guide  211  with the fluid filled lumen(s)  211   f.  As shown, the alignment feature  313  is a projecting ledge while the mating feature  139  ( FIG. 11D ) is an enlarged perimeter segment of the port  132 . However, other affirmative alignment configurations may be used. 
     Still referring to FIGS. 11 A- 11 C, the device guide  311  can have a plurality of circumferentially spaced apart fixation members  319  that reside on a top portion of the device guide and reside above the platform  132 , when in position ( FIG. 11E ). The fixation members  319  can lock against a therapeutic medical device  1000  to fix the device in a longitudinal position, i.e., so that the device  1000  cannot move up or down ( FIGS. 12A, 12B ). 
     Referring to  FIG. 11C , the device guide  311  with the open through lumens  312  is shown adjacent the fluid filled lumen guide  211 . As shown, the top  311   t  of the device guide  311  can have a planar surface and a perimeter region  320  that is free of any channels (unlike the alignment channels  211   i  in the fluid-filled guide  211 ). That is, all channels  312  can be open through channels and can have the same diameter. 
       FIG. 11D  illustrates the multi-lumen guide  311  oriented to align with the alignment feature  139 .  FIG. 11E  illustrates the multi-lumen guide  311  releasably coupled to the trajectory frame  100  with a lower portion thereof in the tubular support  204  and locked via fixation member  133 . 
       FIG. 11F  illustrates an example therapeutic device  1000  aligned with one of the open channels  312  of the multi-lumen guide  311 . The therapeutic device  1110  can have an adjustable depth stop member  1110 . The insertion depth calculated earlier can be marked on the device  1000 , measuring from the distal end  1000   d.  The depth stop  1110  can be attached so that a bottom of the depth stop is aligned with the depth mark  1100   m.  The device  1000  can then be inserted into the desired guide path of a selected open channel  312  until the depth stop bottoms out on top  311   t  of the guide  311 . 
       FIGS. 12A and 12B  illustrate fixation members  319  that can be used to secure the therapeutic device  1000  in place. A single therapeutic device  1000  can be inserted through the multi-lumen guide  311  as shown in  FIG. 12A . Multiple therapeutic devices  1000   1 ,  1000   2 ,  1000   3  can be inserted through different channels  312  of the multi-lumen device  311  to be concurrently in position as shown in  FIG. 12B . 
     In some embodiments, the entire procedure can be carried out inside an MRI scanner room of an MRI suite and a different set of trajectory alignment and selection tools can be used from that shown in  FIGS. 5A-5H . 
     Referring now to  FIG. 13A , a fluid-filled grid  277  can be placed on a subject, i.e., on the head and/or skull S. An MRI scan can be performed encompassing the volume of the grid  277  and the intrabody target region of interest. The surgeon can choose an entry point through the grid  277  using automated or semi-automated trajectory selection/identification navigation systems. See, U.S. Pat. Nos. 8,195,272 and 8,315,689, the contents of which are hereby incorporated by reference as if recited in full herein. As discussed above, a surgeon can elect Option 1 (twist point entry via a twist drill) or Option 2 (larger burr hole) options for creating access for the surgical procedure. For the twist point entry, the centering screw guide  10  ( FIGS. 2D, 2E ) that uses a bone screw to directly anchor over the selected entry point can be used. 
     Referring to  FIGS. 13A-13C , the fluid-filled top  277   t  of the grid  277  can be peeled off, leaving the base grid exposed  277   b.  The centering screw guide  10  can be coupled to the skull using a screw driver  15 , directly onto the selected entry point through the grid base  277   b.  Referring to  FIG. 13D , the primary body  10   b  of the centering guide  10  can be removed leaving the centering guide bone screw  10   s  in place through the grid base  277   b.  As shown in  FIG. 13E , the grid  277  is removed (peeled off the skull), leaving the centering screw  10   s  in place attached to the skull. The centering guide body  10   b  can be reattached to the screw  10   s  so that the centering tool  18  ( FIG. 2D, 2E ) can be inserted directly over it. As discussed above with respect to  FIGS. 2D and 2E , the centering tool  18  ( FIG. 2D ) can be attached to the centering screw guide (concentrically over and onto the guide  10 ). 
     If Option 2 is elected, the surgeon can make a divot on the patient skull through the selected entry point on the marking grid using a marking too. Then, the same protocol as discussed with respect to  FIGS. 2F and 2G  can be used to create a relatively large burr hole in the patient&#39;s skull. 
     As discussed above with respect to  FIGS. 3A-3C , the base  110  of the trajectory frame  100  can be centered over the centering tool  18  and coupled to the patient&#39;s skull through the scalp. Once the scalp mount base  110  is secured, the centering tool  18  and guide  10 , if used, are removed. As discussed above with respect to  FIGS. 4A-4E , the upper portion  100   u  of the trajectory frame  100  can be attached to the base  110 . 
     Referring now to  FIGS. 14A-14D , a targeting cannula  111  can be coupled to the trajectory frame  100  using the fixation thrum screw  133 . The targeting cannula  111  has a fluid filled lumen (fluid column)  111   f  and a cap  111   c.  The targeting cannula  111  has a tubular body that has the inner lumen with a closed bottom end and a larger diameter reservoir  111   r  above the fluid column  111   f . The bottom  111   b  can extend out of the bottom of the tower or tubular member  204  when in position as shown in  FIGS. 14C and 14D . An MRI scanner can scan the image volume with the intrabody target region of interest and the targeting cannula  111  and a surgical navigation system can electronically calculate positional adjustments (i.e., knob rotations for pitch and roll adjustment) to align the trajectory of the tubular member/tower  204  to the desired trajectory.  FIGS. 14E and 14F  illustrate example pitch adjustment using pitch actuator  140   a.    FIGS. 14G and 14H  illustrate example roll adjustment using roll actuator  140   b.    
       FIGS. 14B and 14C  illustrate that the pitch actuator  140   a ′ can be parallel to the tubular member  204  and/or device guide  311  or fluid filled guide  211  and can reside above the platform  132  on a corner of the platform  132  as shown. Thus, the roll and pitch actuators  140   b,    140   a  can be parallel to each other and extend in an upright direction. 
     After the trajectory adjustments to the tower  204  of the trajectory frame  100 , either via the navigation stylus  5  ( FIG. 5C ) discussed above or a targeting cannula  111 , a multi-lumen fluid filled guide array  211  can be used to determine a trajectory selection channel of a guide  311  as discussed above ( FIGS. 6A-6C ,  FIGS. 7A-7E and 8 ). Once the guide array  211  is inserted, an MRI scan that encompasses the volume of the trajectory frame  100  and the intrabody region of interest/target can be performed and pitch and roll adjustments made. The navigation stylus  5  can be used for the CT imaging modality while an MR visible targeting cannula  111  and/or fluid-filled array  211  can be used for an MRI only workflow. 
     Thus, in some embodiments, after a trajectory is set, the targeting cannula  111  can be removed from the tower  204 , and a fluid-filled guide array  211  can used to pick a path to the target. There are a plurality (shown as seven) possible device paths included in the guide array  211 , to give the surgeon multiple options for selecting the safest path to reach the desired target. Also, these additional paths act as a way to counter-act any mounting errors that may have occurred. 
     The fluid filled guide channels  211   f  ( FIGS. 6D, 6E ) of the guide array  211  will be bright parallel lines on an MRI image obtained by an MRI scan or scans. The surgeon can select the lumen position in the array that most closely matches the desired insertion path/trajectory. 
     Alternatively, instead of (or even in combination with) the physical guide array  211 , a virtual a multi-lumen fluid filled guide array  1211  ( FIG. 15A ) can be generated programmatically, and digitally overlaid onto an MRI image comprising the trajectory frame  100 . Thus, the virtual array  1211  can be used to select a corresponding lumen position in a multi-lumen guide  311  ( FIGS. 8 and 11A-11C ) as will be discussed below. 
     As shown in  FIG. 15A , a surgical system  1400  can include an image processing circuit  1600  in communication with the display  1610 . The image processing circuit  1600  can generate an image  1500 ′ that aligns a virtual guide array  1211  and the axis of the tubular member  204  held by the trajectory guide assembly  100 . 
     Referring to  FIGS. 15A and 15B , once a “final” or “set” trajectory alignment has been made, a user interface can prompt a user to select a desired trajectory. The surgical navigation system  1400  can include a display  1610  in communication with a processor  1160  with a virtual array module  1512  that can programmatically generate and automatically overlay a virtual guide array  1211  onto an image  1500 ′, centered axially (indicated by cross-hair center) on longitudinal axis  204 A of the tower  204 . The system  1400  can be in communication with or at least partially onboard a medical imaging system  1515  such as an MRI imaging system (and/or optionally a CT imaging system). The processor  1600  and display  1610  can be provided as components of a workstation  1514 . 
     The system  1400  can automatically orient the virtual array  1211  optionally based on orientation of circumferentially spaced apart fiducial markers  119  ( FIGS. 3A, 7C ) on the base  110  of the trajectory frame  100 . The virtual array  1211  matches the virtual channels  1211   c  with the physical channels of the multi-lumen guide  311  ( FIGS. 8, 11A-11C, 15B ) and orientation indicia  132   i  on platform  132  ( FIGS. 7E, 15B ). The virtual array  1211  can include a plurality of circumferentially and radially spaced apart virtual channels  1211   c , shown as seven channels numbered as channels 1-7, with a center channel (channel 7) surrounded by a concentric set of six equally circumferentially spaced apart channels (numbered as channels 1-6). The virtual array  1211  can also include virtual orientation indicia including a virtual patient left directional indicator  1213  and a virtual directional patient right directional indicator  1214  (shown as a pair of right side markings). The virtual patient left marking  1213  can be aligned and provided to visually match or correspond to the patient left marking  132   il  (on the platform  132 ) and the virtual patient right marking  1214  can visually correspond to the patient right marking  132   ir  (on the platform  132 ) with the virtual markings positioned aligned but radially spaced apart and closer to the tubular member  204  and/or center of the platform  132  than the physical markings  132   i.  The surgeon then selects which path (virtual channel  1211   c ) most closely matches the desired trajectory. 
     If the user has opted to create a smaller entry hole with a twist point drill, then the protocol discussed above with respect to  FIGS. 8, 9A-9C, 10A-10H  can be performed followed by the use of the multi-lumen guide  311  discussed with respect to  FIGS. 11A-11C . If a burr hole entry was performed, then the multi-lumen guide  311  can be attached to the trajectory frame  100  without requiring the twist entry tools and steps. 
       FIG. 16  is a flow chart of example actions that can be used for surgical navigation for a therapeutic treatment according to embodiments of the present invention. A trajectory guide assembly can be affixed to a subject (block  1600 ). A cooperating device comprising either a targeting cannula with a single fluid filled lumen or a guide array with multiple fluid filled lumens can be inserted into a tubular member (tower) of the trajectory guide assembly (block  1610 ). A desired trajectory can be identified using the inserted device (block  1620 ). The device can be replaced with a device guide having a plurality of open lumens (block  1630 ). 
     The insertion can be carried out by inserting the targeting cannula (block  1612 ). The method can include generating an image with the trajectory guide assembly and a virtual array of lumens corresponding to the lumens of the device guide aligned to a longitudinally extending axis of the tubular member held by the trajectory guide assembly (block  1614 ). There can be between 5-9 parallel and open through lumens in a body of the device guide that extends above and below the tubular member (block  1632 ). The tubular member can be held directly on a platform with orientation indicia and the virtual array can also include orientation indicia corresponding to that on the platform (block  1634 ). 
     The surgical navigation system  1500  ( FIG. 15A ) can take the form of an entirely software embodiment or an embodiment combining software and hardware aspects, all generally referred to herein as a “circuit” or “module”. Furthermore, the present invention may take the form of a computer program product on a computer-usable storage medium having computer-usable program code embodied in the medium. Any suitable computer readable medium may be utilized including hard disks, CD-ROMs, optical storage devices, a transmission media such as those supporting the Internet or an intranet, or magnetic storage devices. Some circuits, modules or routines may be written in assembly language or even micro-code to enhance performance and/or memory usage. It will be further appreciated that the functionality of any or all of the program modules may also be implemented using discrete hardware components, one or more application specific integrated circuits (ASICs), or a programmed digital signal processor or microcontroller. Embodiments of the present invention are not limited to a particular programming language. 
     Computer program code for carrying out operations of data processing systems, method steps or actions, modules or circuits (or portions thereof) discussed herein may be written in a high-level programming language, such as Python, Java, AJAX (Asynchronous JavaScript), C, and/or C++, for development convenience. In addition, computer program code for carrying out operations of exemplary embodiments may also be written in other programming languages, such as, but not limited to, interpreted languages. Some modules or routines may be written in assembly language or even micro-code to enhance performance and/or memory usage. However, embodiments are not limited to a particular programming language. As noted above, the functionality of any or all of the program modules may also be implemented using discrete hardware components, one or more application specific integrated circuits (ASICs), or a programmed digital signal processor or microcontroller. The program code may execute entirely on one (e.g., a workstation computer), partly on one computer, as a stand-alone software package, partly on the workstation&#39;s computer or Scanner&#39;s computer and partly on another computer, local and/or remote or entirely on the other local or remote computer. In the latter scenario, the other local or remote computer may be connected to the user&#39;s computer through a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). 
     The present invention is described in part with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks. 
     These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function/act specified in the flowchart and/or block diagram block or blocks. 
     The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing some or all of the functions/acts specified in the flowchart and/or block diagram block or blocks. 
     The flowcharts and block diagrams of certain of the figures herein illustrate exemplary architecture, functionality, and operation of possible implementations of embodiments of the present invention. In this regard, each block in the flow charts or block diagrams represents a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It should also be noted that in some alternative implementations, the functions noted in the blocks may occur out of the order noted in the figures. For example, two blocks shown in succession may in fact be executed substantially concurrently or the blocks may sometimes be executed in the reverse order or two or more blocks may be combined, depending upon the functionality involved. 
     As illustrated in  FIG. 17 , embodiments of the invention may be configured as a data processing system  2000 , which can be used to carry out or direct operations of the surgical navigation system  1400 , and can include a processor  1600 , a memory  2336  and input/output circuits  2346 . The data processing system may be incorporated in, for example, one or more of a personal computer, workstation  1514  ( FIG. 15A ), server(s) or the like. The system  2000  can reside on one machine or be distributed over a plurality of machines and/or be a cloud based system. The processor  1600  communicates with the memory  2336  via an address/data bus  2348  and communicates with the input/output circuits  2346  via an address/data bus  2349 . The input/output circuits  2346  can be used to transfer information between the memory (memory and/or storage media)  2336  and another computer system or a network using, for example, an Internet protocol (IP) connection. These components may be conventional components such as those used in many conventional data processing systems, which may be configured to operate as described herein. 
     In particular, the processor  1510  can be commercially available or custom microprocessor, microcontroller, digital signal processor or the like. The memory  2336  may include any memory devices and/or storage media containing the software and data used to implement the functionality circuits or modules used in accordance with embodiments of the present invention. The memory  2336  can include, but is not limited to, the following types of devices: ROM, PROM, EPROM, EEPROM, flash memory, SRAM, DRAM and magnetic disk. In some embodiments of the present invention, the memory  336  may be a content addressable memory (CAM). 
     As further illustrated in  FIG. 17 , the memory (and/or storage media)  2336  may include several categories of software and data used in the data processing system: an operating system  2352 ; application programs  2354 ; input/output device drivers  2358 ; and data  2356 . As will be appreciated by those of skill in the art, the operating system  2352  may be any operating system suitable for use with a data processing system, such as IBM®, AIX® or zOS® operating systems or Microsoft® Windows2000 or WindowsXP operating systems, Windows Visa, Windows7, Windows CE or other Windows versions from Microsoft Corporation, Redmond, Wash., Palm OS, Symbian OS, Cisco IOS, VxWorks, Unix or Linux™ Mac OS from Apple Computer, LabView, or proprietary operating systems. IBM, AIX and zOS are trademarks of International Business Machines Corporation in the United States, other countries, or both while Linux is a trademark of Linus Torvalds in the United States, other countries, or both. Microsoft and Windows are trademarks of Microsoft Corporation in the United States, other countries, or both. The input/output device drivers  2358  typically include software routines accessed through the operating system  2352  by the application programs  2354  to communicate with devices such as the input/output circuits  2346  and certain memory  2336  components. The application programs  2354  are illustrative of the programs that implement the various features of the circuits and modules according to some embodiments of the present invention. Finally, the data  2356  represents the static and dynamic data used by the application programs  2354  the operating system  2352  the input/output device drivers  2358  and other software programs that may reside in the memory  2336 . 
     The data  2356  may include (near real time or archived or stored) digital image data sets  2326  that provide image data including image volumes encompassing the trajectory frame and intrabody target (typically also comprising DICOM data to correlate the image data to respective patients). The data  2356  may include defined trajectory frame orientation features such as fiducial features and positions for defining an orientation of the trajectory frame  100  in image space and/or to patient right, patient front and patient left. 
     As further illustrated in  FIG. 17 , according to some embodiments of the present invention application programs  2354  include a Device Guide Module for a device guide with a plurality of parallel open lumens  2324  and an optional Virtual Array Module  1512 . The application program  2354  may be located in a local server (or processor) and/or database or a remote server (or processor) and/or database, or combinations of local and remote databases and/or servers. 
     While the present invention is illustrated with reference to the application programs  2354 , and Modules  2324 ,  1512  in  FIG. 17 , as will be appreciated by those of skill in the art, other configurations fall within the scope of the present invention. For example, rather than being application programs  2354  these circuits and modules may also be incorporated into the operating system  2352  or other such logical division of the data processing system. Furthermore, while the application programs  2354  are illustrated in a single data processing system, as will be appreciated by those of skill in the art, such functionality may be distributed across one or more data processing systems in, for example, the type of client/server arrangement described above. Thus, the present invention should not be construed as limited to the configurations illustrated in  FIG. 17  but may be provided by other arrangements and/or divisions of functions between data processing systems. For example, although  FIG. 17  is illustrated as having various circuits and modules, one or more of these circuits or modules may be combined or separated without departing from the scope of the present invention. 
     In particular embodiments, the system  1400  can include or be in communication with a PACS (picture archiving and communication) system. The system  1500  can include, for example, at least one server and/or at least one (clinical) client (e.g., workstation). 
     The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.