Stereotactic guidance system adapted for high-intensity focused ultrasound

Abstract

A stereotactic guidance system comprises a stereotactic frame attachable to a head of a patient and configured to provide reference points for a neurosurgical procedure. A High-Intensity Focused Ultrasound (HIFU) adaptor removably attaches to the stereotactic frame and is positioned to emit focused ultrasound directed toward a predetermined target of the patient. The stereotactic frame HIFU adapter comprises a size and shape that is supportable by the frame in a floating, fixed position relative to the predetermined target.

Description

VIA EFS Docket No. 060236-524001 WO Date of Filing: February 4, 2026STEREOTACTIC GUIDANCE SYSTEM ADAPTED FOR HIGH-INTENSITY FOCUSED ULTRASOUNDCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to U.S. Patent Application No. 63 / 754,341, filed on February 5, 2025, entitled “STEREOTACTIC GUIDANCE SYSTEM ADAPTED FOR HIGH-INTENSITY FOCUSED ULTRASOUND”, the contents of which is hereby incorporated by reference herein in its entirety.BACKGROUND

[0002] Traditional stereotaxy is a minimally invasive surgical technique that relies on a coordinate mapping system guided by various surgical guidance modalities, which can include, for example, infrared cameras, optical guidance, MRI, CT, C-Arms, O-Arm, etc. A standard practice of stereotactic surgery is executed using a variety of stereotactic frames supporting the alignment of devices such as cannulas, biopsy needles, catheters, deep brain stimulation leads, or other therapeutic devices with the pre-planned trajectories using the coordinate mapping system. In general, the accepted targeting accuracy for a standard clinical procedure guided by stereotaxy is in the range of < 2mm.SUMMARY

[0003] High-Intensity Focused Ultrasound (HIFU) is a developing technology in the space of medical treatments. Pursuant to a HIFU procedure, the high intensity of the focused ultrasound waves in combination with traditional concepts of beamforming is used to illicit biomechanical responses at the targeted area, typically the focal area of the HIFU waves.

[0004] Disclosed are systems and methods wherein stereotactic frames are adapted for direct, integrated use as a primary guidance tool for precision targeting of HIFU applications. A HIFU transmitter having a predetermined form factor and size includes an adapter for use with a common stereotactic frame system. The HIFU transmitter is directly integrated into the stereotactic frame system in a manner that does not interrupt the existing fiducials required for a frame’s coordinate system. The system is described in a non-limiting example context of use with a stereotactic frame such as Orchestra Navigation System sold by ClearPoint Neuro, Inc.Docket No. 060236-524001 WO

[0005] A level of targeting accuracy achieved by the disclosed system achieves a desirable range for traditional stereotaxy such as within less than 2mm from the intended target. The disclosed system also can achieve sub-millimeter accuracy to a planned HIFU excitation site. Such a level of targeting accuracy enables HIFU applications including, but not limited to, ablation, neuromodulation, and / or disruption of the blood brain barrier with much more flexibility to the procedural workflow and / or ultrasound parameters. The pairing of capabilities between the HIFU technology, with the reliability of stereotactic frames to historically align and guide devices to anatomies including, but not limited to the putamen, thalamus, substantia nigra, etc., enables new routes of administration for neurological therapies that are less invasive with promising efficacies. The stereotactic frame is configured to position the HIFU adapter relative to a patient to achieve less than 2 mm of target accuracy for emission of focused ultrasound toward the target.

[0006] In a non-limiting example, the disclosed system is used to disrupt the blood brain barrier (BBB) of an intended drug delivery target site non-invasively through a patient’s skull. Once the BBB is temporarily disrupted, an infusion of an intended therapy can occur through intravenous (IV) access, which poses less of a procedural risk to the patient compared to traditional intraparenchymal delivery. Due to the disrupted BBB at the target site, the therapy eventually crosses the temporarily porous BBB to the intended site for uptake through the vascular pathways. The patient in this scenario can achieve the treatment output with less risk of adverse effects, and a much quicker recovery period post treatment.

[0007] In one aspect, there is disclosed a stereotactic guidance system, comprising a stereotactic frame attachable to a head of a patient and configured to provide reference points for a neurosurgical procedure; and a High-Intensity Focused Ultrasound (HIFU) adaptor removably attachable to the stereotactic frame and positioned to emit focused ultrasound directed toward a predetermined target of the patient, wherein the stereotactic frame HIFU adapter comprises a size and shape that is supportable by the frame in a floating, fixed position relative to the predetermined target.

[0008] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF THE DRAWINGSDocket No. 060236-524001 WO

[0009] FIG. 1 shows a perspective view of a stereotactic frame system configured for use with a stereotactic guidance workflow in conjunction with a High-Intensity Focused Ultrasound (HIFU) adapter assembly.

[0010] FIG. 2 shows an enlarged view of the stereotactic frame system, the HIFU adaptor assembly, and a trajectory guide frame that couples the HIFU adaptor assembly to the frame.

[0011] FIG. 3 shows an enlarged view of the HIFU adaptor assembly.

[0012] FIGS. 4 and 5 show enlarged views of an outer housing of the HIFU adaptor assembly.

[0013] FIG. 6 shows an enlarged view of the trajectory guide frame.

[0014] FIG. 7 is a top perspective view of a stereotactic frame system with elongate support legs.DETAILED DESCRIPTION

[0015] FIG. 1 shows a perspective view of a stereotactic frame system 10 (also referred to as a surgical tool support system 10) that is configured for use with a stereotactic guidance workflow adapted in conjunction with High-Intensity Focused Ultrasound (HIFU). A HIFU adaptor assembly 15 is mechanically and communicatively coupled to the stereotactic frame system 10 via coupling with a trajectory guide assembly 17. The HIFU adaptor assembly 15 enables the surgical tool support system 10 to be used with a HIFU workflow, as described further below. The stereotactic frame system 10 and HIFU adaptor assembly 15 are mounted on a platform such as a patient support surface 50 configured to support a patient such as in a prone position. The patient can be positioned such that the stereotactic frame system 10 is coupled to a skull of the patient as described further below.

[0016] FIG. 2 shows an enlarged view of the stereotactic frame system 10, the trajectory guide assembly 17, and the HIFU adaptor assembly 15. The HIFU adaptor assembly 15 removably attaches to the trajectory guide assembly 17 to mechanically couple the HIFU adaptor assembly 15 to the stereotactic frame system 10. In this regard, the HIFU adaptor assembly 15 includes an adapter arm 19 that removably inserts into a guide bore 21 of the trajectory guide assembly 17 to secure the HIFU adaptor assembly 15 to the stereotactic frame system 10. The HIFU adaptor assembly 15 is thereby fixedly positioned to emit focused ultrasound directed at or toward a predetermined target such as in a brain of aDocket No. 060236-524001 WOpatient. The trajectory guide frame provides a trajectory to guide placement of the HIFU adaptor. The HIFU adaptor removably attaches to the trajectory guide frame to align the HIFU adaptor along the trajectory axis.

[0017] The trajectory guide frame 17 hold or retains the HIFU adaptor assembly 15 in a suspended and hovering position so that it is positioned and riented along a specific trajectory for focused neuromodulation, target ablation, disruption of the blood-brain-barrier, or other intervention. The HIFU adaptor assembly 15 may be suspended relative to a patient such as relative to the patient’s skull. Precise alignment of the HIFU adaptor assembly 15 with respect to high-resolution structural MRI allows for patient-specific interventional applications.

[0018] FIG. 3 shows an enlarged view of the HIFU adaptor assembly 15, which includes an outer housing 22 attached to the elongated adapter arm 19. The adapter arm 19 extends along an axis A- A. In the example implementation, the adapter arm 19 is configured to be threaded coaxially through the guide bore 21 (FIG. 2) of the trajectory guide assembly 17, as described further below. The adapter arm 19 is attached to the outer housing 22, which can be substantially cylindrical in shape in a non-limiting example. In a non-limiting example, the housing has dimensions of 55 - 70 mm in height and 50-85 mm in diameter. In an implementation, the outer housing 22 is puck shaped.

[0019] The size and form factor of the HIFU adaptor assembly 15 can vary. Some factors that govern such size and form factor include power level required to drive appropriate signal strength for successful HIFU applications, heat dissipation, operating room environment in terms of both hardware and raw materials used, and the stability and strength of the specific stereotactic frame to which it is integrated. The form factor scale and size can be relative to a size of the stereotactic frame it is being integrated into. The size and form factor desirably remains within the specific geometric constraints and height offset of the stereotactic frame’s inner arc or operational space (proximal to the frame’s holding point and closer to the subject’s head, to allow for direct placement of the HIFU PZT array to the patient’s skull) without hindering the frame’s operational range. The geometry of the form factor does not inhibit the combined stereotactic and ultrasound beamforming solution from achieving a trajectory that the frame can achieve without the HIFU device attached. The HIFU adaptor assembly 15 (including any accompanying hardware within the sterile field) and adapters can either be re- sterilizable and therefore reusable by design or single one time use disposables.Docket No. 060236-524001 WO

[0020] FIGS. 4 and 5 show enlarged views of the outer housing 22 of the HIFU adaptor assembly 15. In a non-limiting example implementation, the outer housing 22 of the HIFU adapter assembly 15 has a small, circular disk or puck form factor configured to operate within a sterile field. The housing 22 contains all power hardware and signal generating hardware components within the housing 22. The housing 22 is shown having a circular outer contour that provides a cylindrical shape although this can vary. A mount 23 removably attaches to the adapter arm 19 (FIG. 3). The mount 23 is a structure that can be removably attached to the arm 19 such as to a tip of the arm 19.

[0021] In an alternate implementation, the HIFU adapter assembly 15 has signal generating piezoelectric array with none or only a subset of the signal generating / power components contained within the housing. A remainder of the hardware communicates with in a remote control unit connected through a wire or wireless medium. Such a wireless option may have certain advantages in the space constraints that exist in most standard operating rooms or MRI and can bring about certain workflow efficiencies that are needed for unique procedures at the cost of signal fidelity.

[0022] As discussed above with reference to FIGS. 1 and 2, the HIFU adaptor assembly 15 removably attaches to the stereotactic frame system 10 via the trajectory guide frame 17. FIG. 6 shows an enlarged view of the trajectory guide frame 17, which is configured to be used for localized placement of the HIFU adapter assembly 15 relative to an anatomical structure, such as on the surface of, or within, the brain or other anatomy. The guide frame 17 can be used during radiological imaging-guided surgeries (e.g., magnetic resonance imaging (MRI), computerized tomography (CT), etc.). The guide frame can further be used with optical navigation in conjunction with pre- and / or intraoperative imaging. It should be appreciated that use with the brain is a non-limiting example and that the systems and methods described herein can be used with other anatomy.

[0023] With reference still to Figure 6, the trajectory guide frame 17 includes the elongated guide bore 21 that extends along an axis B-B. The axis B-B co-axially aligns with the axis A- A of the elongated adapter arm 19 (FIG. 3) when the elongated adapter arm 19 is inserted into the guide bore 21. The elongated guide bore 21 is configured to guide placement of the HIFU adaptor assembly 15 by inserting the elongated adapter arm 19 into and through an inner lumen of the guide bore 21. The trajectory guide frame 17 includes one or more actuators each operable to move the guide bore 110 relative to a patient such as relative to a skull of the patient. This enables a user to position and adjust the trajectory axis A to aDocket No. 060236-524001 WOdesired intrabody trajectory, which can be used to guide placement of the HIFU adaptor assembly 15 and a subsequent interventional device in vivo.

[0024] Although the HIFU adaptor assembly 15 is described herein as mating with the trajectory guide frame 17 via the elongated adapter arm 19, it should be appreciated various types of mating features to any stereotactic frame of interest are included as part of this disclosure. Integration of the HIFU adaptor assembly 15 with a stereotactic frame requires none or minimal modifications to the existing navigational workflow associated with the stereotactic frame, in terms of alignment to a predetermined coordinate / trajectory within their own coordinate system.

[0025] With reference still to FIG. 6, a base 29 of the trajectory guide frame 17 includes an attachment mechanism 31 that enables trajectory guide frame 17 to be secured to the stereotactic frame system 10. When attached to the stereotactic frame system 10, the trajectory guide frame 17 can then be securely positioned above the patient’s body such as in a “floating” arrangement such that the trajectory guide frame 17 provides minimal, if any, obstruction of a surgical field. The HIFU adapter has a weight such that the stereotactic frame can support the HIFU adapter in the fixed position such that the HIFU adapter does not sag or otherwise move when attached to the stereotactic frame. The HIFU adapter HIFU adapter comprises a housing that contains a signal generating piezoelectric array and power components. The HIFU adapter HIFU adapter comprises a housing that contains a signal generating piezoelectric array but does not contain a power component.

[0026] The trajectory guide frame 17 includes one or more movement actuators that can be actuated to move or otherwise adjust a position of the trajectory guide frame 17 and thereby adjust and align the trajectory axis A-A of the HIFU adaptor assembly 15. In an embodiment, the actuators provide for at least five (5) degrees of freedom including translation of a coupled interventional device in the X, Y, and Z axes, and to also pivot or rotate the interventional device in pitch and roll. In some embodiments, the actuators are dials or thumbscrew-type devices that allow manual manipulation thereof. In other embodiments, the actuators may be manipulated remotely and / or automatically.

[0027] With reference to FIG. 6, the base 29 includes a portion 34 that can be movably adjusted along an arced or otherwise curved pathway to permit rotational movement. Other actuators 37 can be actuated to provide translational movement and / or additional rotation movement. In addition, a collar 29 can be actuated to provide depthDocket No. 060236-524001 WOadjustment. The collar 39 can include one or more indicator markings to facilitate alignment and provide indications to a user regarding length of travel.

[0028] In an example embodiment, the trajectory guide frame 17 is configured for use with cranial-based surgeries. As discussed, other interventions are within the scope of this disclosure including spinal, urological, cardiac, and other interventions. The trajectory guide frame 17 is primarily described herein for use with the HIFU adaptor assembly 15. The HIFU adaptor assembly 15 can be switched out of the trajectory guide frame 17 and replaced with other devices configured for use with other surgical modalities. For example, any of a variety of other devices such as interventional devices can be used with the trajectory guide frame 17, including for example ablation devices (e.g., laser, ultrasound, radio frequency, cryo, etc.) and infusion / aspiration devices (e.g., drug delivery cannula, biopsy needles, etc.) by inserting the interventional device through or otherwise coupling it to the elongated guide bore 110. When using these therapeutic devices intraoperatively, the trajectory guide frame 17 can be communicatively coupled to software that is tailored to each application and / or trajectory guide frame 17 such as to prescribe and / or perform automatic device advancement / retraction.

[0029] In this manner, the HIFU adaptor assembly 15 can be used with the trajectory guide frame 17 to provide easy integration to switch between various supported surgical navigation modalities. The disclosed system enables a workflow that allows for an additional therapeutic device to be delivered at the same location as the targeted HIFU application with high accuracy without losing positional integrity. There is no need to realign, swap devices, or remove the HIFU adaptor assembly 15 resulting in a simpler and faster procedure.

[0030] In an embodiment, one or more removable MRI-visible fiducials can be used such that the trajectory guide frame 17 is made operable with software under MRI guidance. In addition to fiducials, the guide tool can be replaced with a targeting cannula that is MR-visible.

[0031] In an embodiment, the trajectory guide frame 17 is used to implant stereoelectroencephalography (SEEG) leads into the brain. Currently, leads are implanted based solely off a preoperative plan, and typically performed via a robotic arm that only can be navigated to the preoperative plan. With use of the trajectory guide frame 17, a trajectory can be modified intraoperatively, such as by using intraoperative imaging, to improveDocket No. 060236-524001 WOplacement accuracy and safety. Additionally, the ability of the trajectory guide frame 17 to integrate with optical navigation, or other intraoperative CT OR workflows, and the ability of the frame to “float” over the cranium allows for rapid deployment of the SEEG leads.

[0032] The interchangeable device guides may be configured to guide placement of an interventional device in vivo. Various instrumentation and equipment can be inserted through the frame to execute diagnostic and / or interventional procedures.

[0033] Pursuant to an example intraoperative method, the trajectory guide frame 17 and corresponding software are used to position and / or guide emission of HIFU to the cerebral cortex. As mentioned, the HIFU adaptor assembly 15 can be removed from the trajectory guide frame 17 and replaced with an interventional device for use subsequent to HIFU treatment.

[0034] Referring now FIG. 7, an example stereotactic frame system 10 (also referred to as a surgical tool support system 10) is shown. U.S. Patent No. 11,925,511 describes such a system and is incorporated herein in its entirety. The surgical tool support system 10 comprises a bracket 100 with at least one bracket arm 105. The system 10 also includes a plurality of elongate support legs 120, shown as comprising a first support leg 120i, a second support leg 1202, and a third support leg 1203. The bracket 100 is coupled to the support legs 120and a surgical tool 200. The surgical tool support system 10 can also include a support platform 115. Each of the plurality of elongate support legs 120 comprises longitudinally spaced apart first and second end portions, 121, 122, respectively. The first end portion 121 is coupled to the bracket 100 and the second end portion 122 is coupled to the support platform 115.

[0035] When assembled to the support platform 115, the support legs 120 can reside at an angle “P” that is less than 90 degrees from horizontal and greater than 0 degrees from horizontal, typically in a selectable range of 10 degrees and 80 degrees from horizontal. When assembled, each support leg 120 can reside at a different angle from the horizontal and vertical axes relative to another support leg 120.

[0036] The elongate support legs 120 are independently extendable and retractable in length and lockable into different desired lengths using a locking member 140. The support legs 120 can have a fully retracted length that is in a range of about 1 inch to about 24 inches. As shown, the at least one bracket arm 105 can extend laterally. The at leastDocket No. 060236-524001 WOone bracket arm 105 can reside a distance in a range of about 1 inch to about 24 inches from the second end portions 122 of each leg.

[0037] The support legs 120 can comprise a plurality of leg segments such as at least a first leg segment 120a and a second leg segment 120 / ?. At least one of the first leg segment 120a and the second leg segment 120 / ? can telescopingly extend relative to the other. In some embodiments, the first leg segment 120a can telescopingly extend and extract into the second leg segment 120 / ?. Thus, the first leg segment 120a can have a width / cross-sectional size that is less than that of the second leg segment 120 / ?. The first legsegment 120a can merge into the first end portion 121 and the second leg segment 120b can merge into the second end portion 122. However, the reverse configuration can be used with the second leg segment 120b extending into the first leg segment 120a. The support legs 120 can be provided as upper and lower sets of support legs. The bottom set of support legs 120 can have three segments, shown as a third leg segment 120 c that is adjustable in length relative to the first and / or second leg segments 120a, 120b.

[0038] Still referring to FIG. 7, the support platform 115 can comprise a plurality of spaced apart apertures 115a. The support platform 115 can comprise a plurality of planar segments 1155 that are at different heights and that can couple to one or more end portions 122 of a respective support leg 120. The plurality of planar segments 1155 can include a first or upper segment 115 u and a second or lower segment 115 / , each providing a plurality of apertures 115a. One or more of the segments 1155 can be planar and horizontally oriented.

[0039] The apertures 115a can be provided as an array of regularly spaced apart rows 116 and / or columns 118. However, other arrangements including irregularly spaced apart apertures 115a may be used.

[0040] In the embodiment shown in FIG. 7, the upper segment 115w comprises a lesser number of rows 116 of spaced apart apertures 115 a than the lower segment 115 / . The different segments 1155 can include at least one other segment, e.g., a third segment, that can reside at a height which is between that of the upper segment 1 15 / / and the lower segment 115 / .

[0041] Still referring to FIG. 7, the second end portion 122 of the legs 120 can include a clevis 123 that couples to a pin 125. The pin 125 is slidably and selectivelyDocket No. 060236-524001 WOpositionable in one of the apertures 115a. The pin 125 can be sized and configured to frictionally engage an inner wall surface surrounding a respective aperture 115a.

[0042] The pin 125 can engage a selected aperture 115a with sufficient frictional engagement force to secure a respective elongate support 120 to support loading forces associated with a torque arm of the assembly 10 to thereby secure the surgical tool 200 in a desired position. A rod 128 can couple the pin 125 to a respective clevis 123. The rod 128 can have a smaller thickness and / or diameter than the pin 125. The pin 125 can comprise a head 1257? that resides between sidewalls 123w of the clevis 123. The pin 125 can have any suitable shape. The pin 125 can be cylindrical. The pin 125 can have cylindrical body segment 125 b that resides in an aperture 115a of the support platform and a head 125 h with a planar shape having a perimeter of any suitable shape such as a polygon or other shape.

[0043] The clevis 123 can comprise laterally spaced apart apertures in the sidewalls that receive the rod 128. The rod 128 can extend through an openaligned channel 125 c in the pin 125 to couple the pin 125 to the clevis 123 and the elongate support leg 120and define a pivot axis. The clevis 123 and support leg 120 can pivot as a unit relative to the pivot axis and / or the pin 125.

[0044] The first end portion 121 of at least one of the support legs 120 can couple to and / or also include a clevis 223. As shown, the first end portion 121 of each support leg 120 can couple to and / or include a respective clevis 223. The clevis 223 can comprise spaced apart and aligned apertures 223 a in opposing sidewalls 223 w. In some embodiments, the clevis 223 can couple to an attachment member 111 that is defined by and / or coupled to the bracket 100.

[0045] The surgical tool 200 can comprise a trajectory guide. The trajectory guide can include at least one fiducial marker, typically positioned on the base 212 of the bracket 100 at fiducial positions. For additional discussion of suitable trajectory guides, see, U.S. application Ser. No. 12 / 134,412, and co-assigned U.S. patent application Ser. Nos.12 / 236,950 and 14 / 515,105, the contents of which are hereby incorporated by reference as if recited in full herein.

[0046] Referring again to FIG. 7, the surgical tool support assembly 10 can be used with a head fixation assembly 25. The head fixation assembly 25 can have and / or be coupled to side support members 26 that extend upwardly. The side support members 26 canDocket No. 060236-524001 WObe provided as a pair of right and left side support members 26 that are spaced laterally apart a sufficient distance to allow a patient head H to be received therebetween.

[0047] The head fixation assembly 25 can be configured to receive a plurality of skull fixation members 30. In some embodiments, the side support members 26 can comprise vertically spaced apart apertures 33 that can be sized and configured to receive respective head fixation members 30.

[0048] As shown in FIG. 7, the head fixation assembly 25 can also comprise a base member 40. The base member 40 can be configured to reside directly or indirectly on a patient support surface 505. The base member 40 can be configured to provide additional head fixation members 42 that extend upwardly. The base member 40 can abut and couple to an inner end of the side support members 26.

[0049] As shown in FIG. 7, the head fixation assembly 25 can be attached to a scanner table or bed 50 (e.g., a patient support surface) of an MM, CT or other imaging scanner. In the embodiment shown, the head fixation assembly 25 comprises laterally extending members 60 that have opposing inner and outer end portions. The inner end portions are coupled to the side support members 26 while the outer end portions are attached to corresponding right and left side longitudinally extending table mount members 64 that are attached to sides 51 of the scanner bed 50.

[0050] In some embodiments, the vertically spaced apart apertures 33 comprise at least two apertures 33, shown as three, typically provided in a range of 2-6 apertures at different height positions to accommodate different size heads of respective patients and / or supine and occipital positions during a surgical procedure.

[0051] The support platform 115 can be configured to attach to the head fixation assembly 25 and / or the scanner bed 50.

[0052] The surgical tool 200 supported by the system 10 can comprise a trajectory guide 201 with or without a targeting cannula for allowing components such as catheters, needles, leads with electrodes, drill bits, fluid delivery cannulae, or other devices to be inserted into a patient's body along a desired intrabody path through the guide.The tool 200 can reside on or above a patient. The tool 200 can reside against / on an outer surface or skull of a patient for the surgical procedure.

[0053] In some embodiments, the tool 200 may be configured to be supported by the system 10 without requiring attachment to a skull of a patient, which may be particularlyDocket No. 060236-524001 WOsuitable for use with some patients such as pediatric patients or patients with thin skulls or other skull abnormalities.

[0054] The head fixation assembly 25 can cooperate with RF coils to obtain MRI signals. For additional description of suitable head fixation frames, see, e.g., U.S. Pat. No. 8,548,569, the contents of which are hereby incorporated by reference as if recited in full herein.

[0055] The system 10 can be sized and configured to fit within the bounds of a bore of a magnet (for closed bore systems) and can translate in and out of the magnet bore as indicated by arrow and axis La with the patient and scanner bed 50 (FIG. 1) and remain in a fixed position relative to the patient.

[0056] Components of the system 10 can be formed from any suitable material, typically a light-weight and sufficiently rigid, polymeric material, such as, for example, fiberglass, ceramics, fiber reinforced resins, PEEK, ABS, polycarbonate, KEVLAR, and / or Garolite. However, non-ferromagnetic metals or other materials may also be used, particularly when used for non-MM surgical navigation systems.

[0057] The systems 10 may be particularly suitable for use in MM-guided procedures where the procedure is carried out in an MM scanner or MM interventional suite, e.g., deep brain procedures, spinal procedures, cardiac procedures, including but not limited to, cardiac EP procedures where heat or cryogenic ablation is used, as well as intrabody biopsies or treatment of any target organ or tissue, including breast, liver, thyroid, lung, kidney, ovarian, cervical, prostate, urethra, colon, intestine, stomach, and the like. The devices may be particularly suitable for MRLguided procedures that deliver therapeutic agents, such as drugs, antigen, antibody and / or gene therapies, stem cells and the like.However, use in non-MRI image guided systems are also contemplated.

[0058] The system 10 (or appropriate components, depending on use) can be sterilized and may optionally be single-use disposable or portions thereof may be single-use disposable. The devices can be “universal” in that they can be used interchangeably with different MRI scanner systems from different scanner manufacturers. Alternatively, the systems 10 may have different configurations to attach to different Scanner beds, e.g., they may be scanner type or scanner manufacturer specific.

[0059] Implementations of the present disclosure can be configured to carry out or facilitate CT or MM guided procedures, including, for example diagnostic and interventionalDocket No. 060236-524001 WOprocedures such as to guide and / or place interventional devices to any desired internal region of the body or object, including deep brain sites for neurosurgeries or other target intrabody locations for other procedures. The object can be any object and may be particularly suitable for animal and / or human subjects. For example, the system and / or devices thereof can be used for gene, e.g., antibody, and / or stem-cell based therapy delivery or other therapy delivery to intrabody targets in the brain, heart, lungs, liver, kidney, ovary, stomach, intestine, colon, spine or to other locations. In addition, embodiments of the systems can be used to treat cancer sites. In some embodiments, the systems can be used to ablate tissue and / or delivery pharmacologic material in the brain, heart or other locations. In some embodiments, it is contemplated that the systems can be configured to treat AFIB, deliver stem cells or other cardio-rebuilding cells or products into cardiac tissue, such as a heart wall, via a minimally invasive MRI guided procedure while the heart is beating (i.e., not requiring a non-beating heart with the patient on a heart-lung machine).

[0060] The foregoing is illustrative of the present disclosure and is not to be construed as limiting thereof. Although a few exemplary embodiments of this disclosure 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 disclosure. Accordingly, all such modifications are intended to be included within the scope of this disclosure as defined in the claims. The disclosure is defined by the following claims, with equivalents of the claims to be included therein.

Claims

Docket No. 060236-524001 WOCLAIMS1. A stereotactic guidance system, comprising:a stereotactic frame attachable to a head of a patient and configured to provide reference points for a neurosurgical procedure; anda High-Intensity Focused Ultrasound (HIFU) adaptor removably attachable to the stereotactic frame and positioned to emit focused ultrasound directed toward a predetermined target of the patient, wherein the stereotactic frame HIFU adapter comprises a size and shape that is supportable by the frame in a floating, fixed position relative to the predetermined target and wherein the stereotactic frame supports the HIFU adapter in a suspended floating, fixed position relative to the target of the patient.

2. The system of claim 1, wherein the HIFU adapter has a weight such that the stereotactic frame can support the HIFU adapter in the fixed position.

3. The system of claim 1, wherein the HIFU adapter comprises a housing having a disk shape.

4. The system of claim 1, wherein the HIFU adapter HIFU adapter comprises a housing that contains a signal generating piezoelectric array and power components.

5. The system of claim 1, wherein the HIFU adapter HIFU adapter comprises a housing that contains a signal generating piezoelectric array but does not contain a power component.

6. The system of claim 1, wherein the HIFU adapter has dimensions of 55 - 70 mm in height and 50-85 mm in diameter.

7. The system of claim 1, wherein the stereotactic frame is configured to position the HIFU adapter relative to a patient to achieve less than 2 mm of target accuracy for emission of focused ultrasound toward the target.

8. The system of claim 1, further comprising a trajectory guide frame that attached to the stereotactic frame, the trajectory guide frame includes an elongated guide bore that defines a trajectory axis.

9. The system of claim 8, wherein the trajectory guide frame provides a trajectory to guide placement of the HIFU adaptor.Docket No. 060236-524001 WO10. The system of claim 8, wherein the HIFU adaptor removably attaches to the trajectory guide frame to align the HIFU adaptor along the trajectory axis.

11. The system of claim 8, wherein the HIFU adaptor includes an elongated arm that inserts into the elongated guide bore of the trajectory guide frame.

12. The system of claim 8, wherein the HIFU adaptor can be removed from the trajectory guide frame and replaced with an interventional device.

13. The system of claim 12, wherein the interventional device is an infusion or aspiration device including a drug delivery cannula or a biopsy needle.

14. The system of claim 1, wherein the stereotactic frame comprises:a plurality of support legs, wherein each of the support legs comprises longitudinally opposing first and second end portions, and wherein each of the support legs are independently adjustable in length.

15. The system of claim 1, wherein the HIFU adapter is configured to emit focus ultrasound to disrupt a blood brain barrier (BBB) of an intended drug delivery target site.

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