Positional accuracy verification tools for surgical therapy systems

Abstract

The disclosure describes quality assurance tools / systems for verifying the accuracy of patient positional monitoring systems used for brain therapies, such as gamma radiation therapies. The tools / systems provide a three-dimensional positional evaluation system configured to assess positional accuracy of a high-definition motion monitoring (HDMM) camera system used in a radiosurgery system. The tools / systems include a positioning table comprising a plurality of actuators moveable in respective X, Y and Z dimensions. The positioning table comprises at least one fiducial marker visible to the HDMM camera system. The tools / systems also include a platform coupled to the positioning table. The platform is configured to couple to a head rest of the radiosurgery system and has an upper surface that holds the positioning table while allowing the positioning table to translate in X, Y and Z dimensions relative to the platform.

Description

Attorney Docket No. 1184.284. WOPOSITIONAL ACCURACY VERIFICATION TOOLS FOR SURGICAL THERAPY SYSTEMSRelated Applications

[0001] This patent application claims the benefit of and priority to U.S. Provisional Patent Application Serial Number 63 / 719,302, filed November 12, 2024, the contents of which are hereby incorporated by reference as if recited in full herein.Field of the Invention

[0002] The present invention relates generally to devices used during medical procedures to evaluate the accuracy of patient positional monitoring systems used during radiation surgery and may be particularly suitable for use in radiosurgery procedures.Background

[0003] Stereotactic radiosurgery (STS) can be used to treat tumors or veins that have developed differently than usual and other irregularity in the brain. STS is not a standard surgery because there is no cut or incision required. Instead, the radiosurgery focuses small beams of gamma rays / radiation on a tumor or other target with extreme accuracy. Each beam has little effect on the brain tissue it passes through to the target, but a therapeutic dose of radiation can be delivered to the target where the beams converge or meet. One example of an STS is Gamma Knife® radiosurgery from ELEKTA AB, Stockholm, Sweden.

[0004] High Definition Motion Monitoring (HDMM) systems with a camera are conventionally used during radiosurgery to monitor patient motion. If the HDMM detects patient movement outside a defined tolerance, such as about 1.5 mm, the radiation is stopped. Periodic functional checks of the HDMM system are desirable to confirm thepreci si on / accuracy of the HDMM system. Conventionally, there is no standard or easy way to verify the preci si on / accuracy of the HDMM system. There is a need for easy-to-use quality assurance tools that can be installed and used in a repeatable, consistent manner and implemented with HDMM systems to confirm that a respective HDMM system is within the desired preci si on / accuracy in three-dimensions.SummaryAttorney Docket No. 1184.284. WO

[0005] Embodiments of the invention are directed to quality assurance tool that releasably couples to a head rest of a radiosurgery system comprising a platform coupled to a positioning stage movable in X, Y and Z directions relative to the platform.

[0006] The platform can be configured to position a reflector in a front plane at a height that corresponds to a position where a head of a patient resides during treatment to be in optical communication with a camera of an HDMM system.

[0007] Embodiments of the present invention are directed to a three-dimensional positional evaluation system configured to assess positional accuracy of a high-definition motion monitoring (HDMM) camera system used in a radiosurgery system that includes a positioning table with a plurality of actuators moveable in respective X, Y and Z dimensions. The positioning table has at least one fiducial marker visible to the HDMM camera system. The 3-D positional evaluation system also includes a platform coupled to the positioning table. The platform is configured to couple to a head rest of the radiosurgery system and has an upper surface that holds the positioning table while allowing the positioning table to translate in X, Y and Z dimensions relative to the platform.

[0008] The platform can haves a base with a plurality of apertures and with a plurality of downwardly extending tabs. The plurality of apertures can releasably couple to respective upwardly projecting tabs of the head rest and the downwardly extending tabs can releasably engage respective apertures in the head rest.

[0009] The apertures and tabs can be arranged on right and left side portions of the base and optionally also across a back-end portion of the base.

[0010] The platform has a lateral dimension and a longitudinal dimension and can have a base that extends laterally and longitudinally. The base can merge into a body with right and left side walls that extend longitudinally. The right and left side walls can merge into a top of the body forming the upper surface.

[0011] The body can be rectangular and can have an open space that can extend laterally and longitudinally between the right and left side walls. The base can have first and second ends that are spaced apart in the longitudinal dimension. The body can reside closer to the first end of the base than the second end of the base.

[0012] The first end of the base and a first end of the right and left side walls can be in a common laterally extending plane.

[0013] The body can terminate a longitudinal distance from the second end of the base in a range of about 1 inch to about 10 inches.Attorney Docket No. 1184.284. WO

[0014] The upper surface can have a channel configured to securely receive and / or couple to a bottom of the positional table.

[0015] The channel can have right and left side walls that extend in a front to back direction. The upper surface can further include a tab residing at or adjacent the front end of the channel.

[0016] The channel may have a first segment of the right and left side walls that can define a smaller lateral extent therebetween than a second segment extending to a front end of the channel

[0017] The at least one fiducial marker can include a reflector. The tab can be centered between the right and left side walls of the channel, inside or in front of the channel, and can be alignable with the reflector in a lateral dimension.

[0018] The body can have an open space positioned laterally between the right and left side walls and extending longitudinally under the top of the platform and above the base.

[0019] The base can extend across the open space between the right and left side walls and defines a floor of the body thereat.

[0020] The positioning table can be configured to be extendable in the Y dimension over the tab without interference.

[0021] The at least one fiducial marker can include a reflector held in a center of a front vertical plane of the positioning table. The positioning table can be moveable relative to the platform to adjust the front vertical plane in the X, Y and Z dimensions in 0.01 mm increments.

[0022] The channel can have right and left side walls facing each other and extending along at least part of the length of the channel.

[0023] The channel can have a first segment with a first lateral extent that extends a first longitudinal distance. The first segment can merge into a second segment with a second lateral extent that is greater than the first lateral extent. The positioning table can include a positioning stage that does not contact the right and left side walls along the second segment of the channel.

[0024] The positioning table can have a fixed base that abuts the right and left side walls along the first segment.

[0025] The positioning table can have a positioning stage that is moveable in the X, Y and Z dimensions using a rotatable knob of respective X, Y and Z micrometers. The positioning table can have a front (vertically oriented) plane with the at least one fiducial maker. The Y micrometer can extend horizontally off the platform in a rearward direction,Attorney Docket No. 1184.284. WObehind the front plane, the X micrometer can extend horizontally off one side of the platform and the Z micrometer can extend vertically above the platform.

[0026] Other embodiments are directed to a radiosurgery system that includes: a radiation system having a bore, a table longitudinally translatable into and out of the bore, a head rest coupled to the table with first and second posts on opposing lateral sides of the table; and a high-definition motion monitoring (HDMM) system comprising a camera, the camera coupled to the table. The radiosurgery system also includes a quality assurance tool with a positioning table coupled to a platform and including a plurality of actuators moveable in respective X, Y and Z dimensions. The positioning table has at least one fiducial marker visible to the HDMM camera system. The platform is configured to releasably couple to the head rest and has an upper surface that holds the positioning table while allowing the positioning table to translate in X, Y and Z dimensions relative to the platform.

[0027] The platform can have a base that can include a plurality of apertures and / or a plurality of downwardly extending tabs. The plurality of apertures can releasably couple to respective upwardly projecting tabs of the head rest and the downwardly extending tabs can releasably engage respective apertures in the head rest.

[0028] The platform has a lateral dimension and a longitudinal dimension and can include a base that extends laterally and longitudinally. The base can merge into a body with right and left side walls that extend longitudinally. The right and left side walls can merge into a top of the body forming the upper surface.

[0029] The body can be rectangular and can have an open front and rear between the right and left side walls. The base can have first and second ends that are spaced apart in the longitudinal dimension.

[0030] The body can reside closer to the first end of the base than the second end.

[0031] The first end of the base and a first end of the right and left side walls can be in a common laterally extending plane.

[0032] The body can terminate a longitudinal distance from the second end of the base in a range of about 1 to about 10 inches.

[0033] The upper surface can have a channel configured to securely receive and / or couple to a bottom of the positional table.

[0034] The channel can have right and left side walls that extend in a front to back direction. A front tab can be provided in the second segment of the channel and can reside between or in front of the right and left side walls.Attorney Docket No. 1184.284. WO

[0035] The right and left side walls can extend a partial distance of a length of the top of the platform, in front of a rearwardly positioned end wall of the channel, and the front tab can face the end wall.

[0036] The channel can have a first segment that can be a front segment and a second segment that can be a rear segment with different widths.

[0037] The first segment can be a rear segment and the second segment can be a front segment.

[0038] The channel can be bounded at least partially by and / or between right and left side walls that face each other along at least a portion of a length of the channel.

[0039] The channel can have a first segment with a first lateral extent that extends a first longitudinal distance. The first segment can merge into a second segment with a second lateral extent that is greater than the first lateral extent. The positioning table can have a positioning stage that does not contact the right and left side walls along the second segment of the channel.

[0040] The positioning table can include a fixed base that can abut the right and left side walls also abut a laterally extending wall residing between the right and left side walls at a rear end of the channel.

[0041] The positioning table can have a positioning stage that is moveable in the X, Y and Z dimensions using a rotatable knob of respective X, Y and Z micrometers. The positioning table can have a front (vertical) plane with the at least one fiducial marker. The Y micrometer can extend horizontally off the platform in a rearward direction, behind the front plane, the X micrometer can extend horizontally off one side of the platform and the Z micrometer can extend vertically above the platform.

[0042] The radiosurgery system can be a gamma knife radiosurgery system.

[0043] Further features, advantages and details of the present invention will be appreciated by those of ordinary skill in the art from a reading of the figures and the detailed description of the preferred embodiments that follow, such description being merely illustrative of the present invention. Features described with respect with one embodiment can be incorporated with or into other embodiments although not specifically discussed therewith. 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 claimAttorney Docket No. 1184.284. WOalthough not originally claimed in that manner. These and other objects and / or aspects of the present invention are explained in detail in the specification set forth below.Brief Description of the Drawings

[0044] FIG. 1 is a side view of a quality assurance tool coupled to a head rest of a radiosurgery system according to embodiments of the present invention.

[0045] FIG. 2 is a side perspective view of an example head rest without the quality assurance tool.

[0046] FIG. 3 is a top, side perspective view of the quality assurance tool coupled to the head rest of the radiosurgery system shown in FIG. 1.

[0047] FIG. 4 is a front view of the quality assurance tool and radiosurgery system shown in FIG. 1.

[0048] FIG. 5 is a top view of the quality assurance tool and part of the radiosurgery system shown in FIG. 1.

[0049] FIG. 6A is a side perspective view of the quality assurance tool shown in FIG. 1

[0050] FIG. 6B is a side perspective view of another embodiment of the quality assurance tool.

[0051] FIG. 7A is a side perspective view of the platform of the quality assurance tool shown in FIG. 6A.

[0052] FIG. 7B is a side perspective view of the platform of the quality assurance tool shown in FIG. 6B.

[0053] FIG. 8 is a front view of the platforms shown in FIG. 7A with the front view of the platform shown in FIG. 7B being substantially the same.

[0054] FIG. 9A is a side view of the platform shown in FIG. 7A.

[0055] FIG. 9B is a side view of the platform shown in FIG. 7B.

[0056] FIG. 10A is a top view of the platform system shown in FIG. 7A.

[0057] FIG. 10B is a top view of the platform system shown in FIG. 7B.

[0058] FIG. 11A is a bottom view of the platform shown in FIG. 7A.

[0059] FIG. 1 IB is a bottom view of the platform shown in FIG. 7B.

[0060] FIG. 12A is an enlarged top view of a portion of the top of the platform shown in FIG. 10A according to embodiments of the present invention.

[0061] FIG. 12B is an enlarged top view of a portion of the top of the platform shown in FIG. 10B according to embodiments of the present invention.Attorney Docket No. 1184.284. WO

[0062] FIG. 13 is a side perspective view of an example radiosurgery system with a camera of the HDDM system in position for use with the quality assurance tool shown in FIG. 1 according to embodiments of the present invention.

[0063] FIG. 14A is a front, side perspective view of a portion of the quality assurance tool with a reflector positioned at a center of a front vertical plane of the positioning table

[0064] FIG. 14B is a front view of a portion of the quality assurance tool shown in FIG. 14A

[0065] FIG. 14C is a top view of the quality assurance tool with showing X and Y micrometers to measure travel length of a positioning stage in respective X and Y directions.

[0066] FIG. 14D is a side view of the quality assurance tool showing a Z micrometer used to measure travel length of the positioning stage in a Z direction.

[0067] FIGS. 15A and 15B are top perspective views of a quality assurance tool with FIG. 15B marked to show three contact places with walls of a channel holding a positioning stage according to embodiments of the present invention.

[0068] FIGS. 15C and 15D are front, side perspective views of the quality assurance tool with FIG. 15D marked to show a front contact area with a front tab holding the positioning stage according to embodiments of the present invention.

[0069] FIG. 16A and 16B are bottom views of the positioning table showing the positioning stage with FIG. 16B marked to show a perimeter of a fixed portion of the positioning stage, part of which makes contact with the channel walls of the platform (FIGS.15B, 15D) when assembled to the platform according to embodiments of the present invention.

[0070] FIGS. 17A and 17B are top perspective views of a portion of the quality assurance tool with FIG. 17B marked to indicate that when the Y-axis micrometer is rotated, the positioning stage moves parallel to the long walls of the channel according to embodiments of the present invention.

[0071] FIGS. 18A-18C are top, side perspective views of a top portion of the quality assurance tool with FIG. 18A showing the positioning stage extended in a Y direction by 5 mm and with FIG. 18B showing the positioning stage extended in the Y direction by 13 mm by way of example and with FIG. 18C showing the positioning stage extendable in the Y direction to be over the front tab without interference according to embodiments of the present invention.Attorney Docket No. 1184.284. WO

[0072] FIGS. 19A and 19B are front views of an upper portion of the quality assurance tool illustrating motion in the X direction which positions the reflector at different X axis positions according to embodiments of the present invention.

[0073] FIGS. 20A and 20B are front views of an upper portion of the quality assurance tool illustrating motion in the Z-direction which positions the reflector at different Z axis positions according to embodiments of the present invention.Detailed Description

[0074] 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.

[0075] 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 term “FIG.” may be used interchangeably with the word “Figure” or the term “Fig.” in the specification and / or drawings.

[0076] 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.

[0077] 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.Attorney Docket No. 1184.284. WOWell-known functions or constructions may not be described in detail for brevity and / or clarity.

[0078] It will be understood that when an element is referred to as being "on", "attached" to, "connected" to, "coupled" with, "contacting", "supported by" 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 (e.g., indirectly supported, attached, coupled, contacting, connected, coupled, etc...). In contrast, when an element is referred to as being, for example, "directly on", "directly attached" to, "directly connected" to, "directly coupled" with, "directly supported by" 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.

[0079] 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'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.

[0080] The term "about" with respect to a number indicates that the value may vary between + / - 20%.

[0081] The term "bed" is used interchangeably with "table" and refers to a patient support surface or frame thereof (which is typically relatively rigid) that, in operative position, at least partially resides in a radiosurgery therapy system, such as a Gamma Knife® radiotherapy system from Elekta AB, Stockholm, Sweden. The bed can typically translate in a longitudinal direction to position the patient in a bore for radiation therapy.

[0082] The term "MRI-compatible" means that a device is safe for use in an MRI environment that can operate as intended in an MRI environment and not introduce artifacts into MRI images. As such, if residing within the high-magnetic field region of the magnet,Attorney Docket No. 1184.284. WOthe MRI-compatible device is typically made of a non-ferromagnetic material(s) suitable to reside and / or operate in a high magnetic field environment. The term "high magnetic field" refers to magnetic fields above 0.5T, typically between 1.5T to 10T.

[0083] Embodiments of the invention are particularly suitable for veterinarian or human therapeutic or diagnostic use but may be used for research or other purposes.

[0084] The term "sterile" and derivatives thereof means that the component meets regulatory clinical cleanliness standards for medical procedures.

[0085] The term "fiducial marker" refers to a marker that can be electronically identified using image recognition and / or electronic interrogation. The fiducial marker can be provided in any suitable manner, such as, but not limited to, a defined geometric shape, a reflector or other marking or component on or in the device, a coating or fluid-filled component or feature or combinations of different types of fiducial markers that makes the fiducial marker(s) have sufficient signal intensity (brightness) for identifying location and / or orientation information for the device and / or components thereof.

[0086] Although particularly suitable for STS treatment systems, embodiments of the present invention are not limited to radiosurgery systems and can be used for gene, e.g., antibody, and / or stem-cell based therapy delivery systems or other therapy delivery systems using patient positioning monitory systems. Embodiments of the present invention can be configured to be used in both CT / other radiation environments and MRI environments.

[0087] Referring now to FIGS. 1-5, an example quality assurance tool 10 is shown coupled to a therapy system 100. The quality assurance tool 10 comprises a platform 20 that is configured to attach to a positioning table 30 and that is configured to also securely attach to the therapy system 100 to position the platform 20 in a fixed position. The therapy system 100 can comprise a head rest 80 and a table 101 that is configured to be moveable in and out of a bore 100b of the therapy system.

[0088] As shown, the platform 20 comprises a top 20t and a bottom 20b that is coupled to or integral with a base 25. The base 25 is configured to attach to a head rest 80 of the therapy system 100. The top 20t of the platform 20 comprises a channel 22 sized and configured to capture the positioning table 30 while allowing a positioning stage 33 (FIG.18C) to translate relative to the platform 20.

[0089] The positioning table 30 comprises three micrometers 130, each movable in one of an X, Y and Z axis direction. An example positioning table 30 is available from McMaster-Carr, Elmhurst, Illinois, under part number 60935K81. However, custom or other positioning tables may be used. The positioning table 30 can have a front vertical plane 30fAttorney Docket No. 1184.284. WOthat comprises at least one fiducial marker 50, optionally a reflector centered on the front plane 30f, that is moveable in X, Y and Z axis directions. The fiducial marker 50 can be the reflector provided for attaching to a custom face mask (not shown) of a radiotherapy system.

[0090] Referring to FIG. 2, the head rest 80 comprises or is coupled to upwardly projecting arms 70i, 702 (also interchangeably referred to as “posts”) comprising reflectors 71. The head rest 80 can comprise right and left sides comprising apertures 82 and upwardly extending projections 83 that can releasably couple to a face mask for patient immobilization as is well known to those of skill in the art.

[0091] The base 25 of the platform 20 can comprise apertures 26 that are sized and configured to receive the projections 83. The base 25 of the platform 20 can also comprise downwardly extending tabs or projections 28 (FIGS. 8, 9A, 9B, 11 A, 11B). Each downwardly extending tab or projection 28 can slidably engage an aligned one of the apertures 82 of the head rest 80. The apertures 26, 82 can be sized and configured to snugly receive, optionally frictionally engage, the corresponding tabs or projections 83, 28 for stable immobilization of the platform 20.

[0092] Referring to FIGS. 4, 6A and 6B, the bottom 25b of the base 25 can be configured to have outer longitudinally extending side portions 25s that step down to a medial segment 25m with a thicker dimension. The outer side portions 25s can provide the apertures 26 and the downwardly extending tabs or projections 28. The medial segment 25m can reside between the right and left side portions 84 of the head rest 80 and abut inner edges 84i of the right and left side portions 84 to provide further positional stability. The base 25, optionally the medial segment 25m, can taper inwardly from front to back to fit in a recess provided by the head rest 80.

[0093] Referring to FIGS. 1 and 4, the platform 20 can have right and left side walls 21 that extend up from the base 25 and position the top 20t of the platform at a height “Hl” that is in a range of 100-200 mm, typically about 137 mm from the bottom 25b of the base 25. The height Hl can be configured to position the top 20t of the platform 20 a distance in a range of 1-3 inches below the upper end of the arms 70i, 702, and / or within a distance H2 of 1-2 inches below / from the uppermost reflector / fiducial 71u on the arms 70i, 702. The height Hl can be selected to position the fiducial 50, which may comprise a (circular) reflector 50, on the front vertical plane 30f of the positioning table 30 at a position corresponding to a nose of a patient held in the head rest 80 during therapy.

[0094] Referring to FIG. 4, the platform 20 can be configured to have an open center channel 24 bounded by the right and left side walls 21, the top 20t and a floor 25f providedAttorney Docket No. 1184.284. WOby the base 25. While the floor 25f is shown as a closed surface, it may be open or partially open. The side walls 21 can extend in a front-to-back or longitudinal direction and the open center channel 24 can extend for at least a major portion of the height of the platform 20 and the entire longitudinal extent of the side walls 21. This configuration can reduce material costs and / or fabrication time and weight while providing sufficient structural stability. The platform 20, above the base 25, can have a rectangular shape.

[0095] Referring to FIGS. 3, 4 and 6A, the right and left side walls 21 of the platform 20 can be positioned closer to a front 125f of the base 25 than a longitudinally spaced apart back 125b of the base 25. As shown, a front of the side walls 21 can be aligned with the front 125f of the base 25 while the back 21b of the side walls 21 can be positioned a distance L from the back 125b of the base 25. The distance L can be in a range of about 0-250 mm, typically in a range of about 50-150 mm such as in a range of 90-100 mm. In some embodiments, positioning the side walls 21 as shown relative to the base 25 may prevent the platform from bowing when using the head rest 80 as a support, depending on the material(s) used to form the platform or components thereof.

[0096] Referring to FIGS. 1, 3-6A, 6B, 7A, 7B, 10A, 10B, 12A and 12B, the top 20t of the platform 20, 20’ can comprise a channel 22 that is sized and configured to hold at least a portion of the positioning table 30. The channel 22 can have a rear end 22r that extends laterally and is at least partially closed and a longitudinally spaced apart open front end with a front tab 23. The channel 22 can be partially bounded at the rear and part of the sides with walls 22w. The tab 23 can be one or more tabs, shown as a single laterally centered tab.

[0097] FIG. 6A shows the platform 20 with the top 20t and sides 21 having a first length (in a front to back direction). The rear end 22r of the channel 22 can be adjacent the back of the top 20t of the platform 20. The tab 23 can be positioned to be spaced apart a distance “d” rearward from the front 125f of the base 25 and the front of the top 20t of the platform 20.

[0098] Referring to FIG. 6B, this embodiment of the platform 20’ has an extended base 25’ relative to the embodiment shown in FIG. 6A. The extended length of base 25’ positions the back 125b of the base 25’ more rearward (longitudinally) than the embodiment shown in FIG. 6A and can be configured to provide additional connection interfaces to the headrest to affix more securely to the head rest 80 (FIG. 1).

[0099] Referring to FIGS. 9B, 11B, downwardly extending projections or tabs 28 and through apertures 26 can be provided along the right and left sides and at or adjacent theAttorney Docket No. 1184.284. WOback-end portion 125b of the base 25’ to connect with corresponding features of the head rest 80.

[0100] Also, the embodiment of the platform 20’ shown in FIG. 6B can position the positioning table 30 of the micrometer so that it sits flush or closely adjacent to the front of the top 20t of the platform 20’. Referring to FIGS. 9B, 10B and 12B, in some embodiments, the sidewalls 21 and top 20t of the platform 20’ can have a length, in a front to back direction, that is about the same (+ / -20%) as the distance DI between the rear end 22r of the channel 22 and the tab 23. In some embodiments, the distance DI can be about the same as the length, front to back direction, of the positioning table 30 to be configured for snap-fit attachment (FIG. 6B).

[0101] As shown in FIG. 6B, a front of the side walls 21 can be aligned with the front 125f of the base 25’ as discussed for the embodiment shown in FIG. 6A. The back 21b of the side walls 21 can be positioned a distance L from the back 125b of the base 25’. The distance L can be in a range of about 200-300 mm, typically in a range of about 210-250 mm.

[0102] The distance L2 of the base 25’ between a centerline of the front aperture 26 and a centerline of the rear aperture(s) 26 can be in a range of about 210 mm to about 230 mm, such as about 215 mm, 216 mm, 217 mm, 218 mm, 219 mm, and 220 mm.

[0103] As shown in FIGS. 6A, 7A, 10A, and 12A, the closed rear end 22r can merge into a first channel segment 22i that has a lateral width W1 that is less than a lateral width W2 of a longer second segment 222 positioned between the side walls 22w. The first channel segment 22i can have a longitudinal extent that is less than half the longitudinal extent of the second channel segment 222. The first channel segment 22i can have a longitudinal extent in a range of 8-10 mm while the second channel segment 222 can have a longitudinal extent in a range of 30-40 mm. The width W1 can be about 24 mm while the width W2 can be about 32 mm. The front tab 23, the closed rear end 22r and the side walls 22w along the first channel segment 22i with the first lateral width W1 can define four contact locations for the fixed base of the positioning table 30. The side walls 22w can be configured to be spaced apart from the fixed base and / or positioning stage of the positioning table 30 as will be discussed further below.

[0104] The channel 22 can be positioned closer to the back 21b of the side walls 21 than the front 21f. Referring to FIG. 3, the front tab 23 and front end of the side walls 22w can be positioned a distance d in a range of 0 mm - 80 mm, more typically d is in a range of about 20-50 mm from the front 21f of the side walls 21 and / or front 125f of the base 25.Attorney Docket No. 1184.284. WO

[0105] The channel 22 can be formed as a recess with the side walls 22w formed by the upper surface of the platform 20 instead of raised walls positioned above the upper surface of the platform 20 as shown. Other configurations may be used to hold the positioning table 30.

[0106] The channel 22 can be reversed so that the first segment 22i can be a front segment and the second segment 222 can be a rear segment.

[0107] Referring to FIGS. 6B, 7B, 10B, and 12B, the rear end 22r can merge into a channel segment 22 that has the lateral width Wl. This channel segment 22 can extend a short subset of the length of the top 20t of the platform 20’, such as a distance of 5% to about 25% of this length of the top of the platform 20’. In some embodiments, the length of the channel segment 22 is less than a width dimension of the channel 22 and can be in a range of about 7 mm to about 15 mm, such as about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm and about 15 mm, in some particular embodiments.

[0108] FIGS. 11 A, 11B show that a cross-strut 25c can be formed in the bottom of the base 25, 25’ along a portion of the medial segment 25m.

[0109] The platform 20, 20’ may be formed in any suitable manner including, for example, 3-D printing, molding, machining and the like. In some embodiments, the platform 20 can be 3-D printed using a polymer or co-polymer such as thermoplastic material comprising polyactic acid (PLA). Components may be reusable or single-use disposable.

[0110] FIG. 13 illustrates an example radiosurgery system 100 with the bore 100b and table 101 used with the quality assurance tool 10. The camera 120 of the HDMM system can be mounted on an arm 110 that can be moved in and out of position.

[0111] FIGS. 14A and 14B shows the fiducial marker 50 can be provided as the same type and configuration of reflector 50r provided by the original equipment manufacturer (OEM) for use during treatment and is compatible with the existing HDMM system without modification or changes to the HDMM system. This reflector 50 can be centered on the front plane 30f of the three-axis positioning table 30. Referring to FIGS. 14C and 14D, the three micrometers 130 can be used to independently adjust the front plane 30f of the positioning table 30 and therefore the reflector 50r, in the X, Y and Z directions as shown by the arrows depicting these movements. As shown in FIG. 14C, the Y axis micrometer 130 can extend horizontally off the back of the top 20t of the platform 20 while the X axis micrometer 130 extends horizontally off one side of the top 20t of the platform 20. FIG. 14D shows the ZAttorney Docket No. 1184.284. WOaxis micrometer 130 extending vertically above the top 20t of the platform 20. The micrometers can travel lengths / distances in 0.01 mm increments.

[0112] The base 25, 25’ of the quality assurance tool 10 can snap securely to the head rest 80 using the features discussed above. The positioning table 30 can be provided preassembled to the platform 20, 20’ or can be assembled at an OEM facility or onsite to engage the channel 22 with the fiducial marker / reflector 50 facing down the length of the table. The HDMM system 123 (FIG. 13) can be activated and the HDMM camera 120 (FIG. 13) placed into the treatment position. The actual movement of the reflector 50 based on the micrometers 130 can be compared to the movement identified by the HDMM system 123. If a discrepancy is identified, a service call by an authorized service provider can be made to troubleshoot and / or repair the system as needed.

[0113] FIGS. 15A and 15B show the channel 22 in which the positioning stage 33 sits and in which the fixed base 34 makes contact in a plurality of places. FIG. 15B marks three places at the rear 22r and (right and left) side walls at the first segment 22i of the channel 22. FIGS. 15C and 15D show another (fourth) contact location at the front tab 23 with the inner surface 23i of the front tab 23 abutting the fixed base 34. FIG. 15D marks the fourth contact location of the fixed base 34. The contact areas hold the positioning table 30 in place at its fixed base 34. The fixed base 34 remains in a fixed position relative to the platform 20 even when the micrometers 130 are translated.

[0114] FIGS. 16A and 16B show an underside of the positioning table 30 with the positioning stage 33 having a perimeter 33p and the fixed base 34. FIGS. 17A and 17B show the side walls 22w along the second segment 222 of the channel 22 that do not contact the positioning stage 33 but can be used for a visual aid for aligning the positioning stage when assembling to the platform 20.

[0115] FIGS. 18A and 18B show that when the Y-axis micrometer 130 is rotated, the positioning stage 33 moves parallel to the second segment 222 of the channel 22 (arrows in FIG. 17B). FIG. 18A shows the positional stage 33 extending in the -Y direction by 5 mm and FIG. 18B shows the positioning stage 33 extending in the Y-direction by 13 mm. FIG.18C shows that as the positioning stage 33 moves forward in the Y-direction, it passes over the front tab 23 without interference.

[0116] FIGS. 19A and 19B show examples of X-direction movement positioning the fiducial marker (e.g., reflector) 50 at different lateral positions relative to the front tab 23 and platform 20. FIGS. 20A and 20B show examples of Z-direction movement positioning the reflector 50 at different height positions relative to the front tab 23 and platform 20.Attorney Docket No. 1184.284. WO

[0117] 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.

Claims

Attorney Docket No. 1184.

284. WOTHAT WHICH IS CLAIMED IS:

1. A three-dimensional positional evaluation system configured to assess positional accuracy of a high-definition motion monitoring (HDMM) camera system used in a radiosurgery system, comprising:a positioning table comprising a plurality of actuators moveable in respective X, Y and Z dimensions, wherein the positioning table comprises at least one fiducial marker visible to the HDMM camera system; anda platform coupled to the positioning table, wherein the platform is configured to couple to a head rest of the radiosurgery system and has an upper surface that holds the positioning table while allowing the positioning table to translate in X, Y and Z dimensions relative to the platform.

2. The three-dimensional positional evaluation system of Claim 1, wherein the platform comprises a base with a plurality of apertures and with a plurality of downwardly extending tabs, wherein the plurality of apertures releasably couple to respective upwardly projecting tabs of the head rest and the downwardly extending tabs releasably engage respective apertures in the head rest.

3. The three-dimensional positional evaluation system of Claim 1, wherein the platform has a lateral dimension and a longitudinal dimension and comprises a base that extends laterally and longitudinally, wherein the base merges into a body with right and left side walls that extend longitudinally, and wherein the right and left side walls merge into a top of the body forming the upper surface.

4. The three-dimensional positional evaluation system of Claim 3, wherein the body is rectangular and has an open space extending laterally and longitudinally between the right and left side walls, wherein the base has first and second ends that are spaced apart in the longitudinal dimension, and wherein the body resides closer to the first end of the base than the second end of the base.

5. The three-dimensional positional evaluation system of Claim 4, wherein the first end of the base and a first end of the right and left side walls are in a common laterally extending plane.Attorney Docket No. 1184.

284. WO6. The three-dimensional positional evaluation system of Claim 4, wherein the body terminates a longitudinal distance from the second end of the base in a range of about 1-10 inches.

7. The three-dimensional positional evaluation system of Claim 1, wherein the upper surface comprises a channel configured to receive and / or couple to the positional table.

8. The three-dimensional positional evaluation system of Claim 7, wherein the channel is bounded at least partially by right and left side walls that extend in a front to back direction along at least part of a length of the channel, and wherein the upper surface further comprises a tab residing in or adjacent a front end of the channel.

9. The three-dimensional positional evaluation system of Claim 8, wherein the at least one fiducial marker comprises a reflector, and wherein the tab is centered between the right and left side walls of the channel, laterally alignable with the reflector in a lateral dimension.

10. The three-dimensional positional evaluation system of Claim 3, wherein the body has an open space positioned laterally between the right and left side walls and extending longitudinally under the top of the platform and above the base.

11. The three-dimensional positional evaluation system of Claim 10, wherein the base extends across the open space between the right and left side walls and defines a floor of the body thereat.

12. The three-dimensional positional evaluation system of Claim 8, wherein the positioning table is configured to be extendable in the Y dimension over the tab without interference.

13. The three-dimensional positional evaluation system of Claim 1, wherein the at least one fiducial marker comprises a reflector held in a center of a front vertical plane of the positioning table, and wherein the positioning table is moveable relative to the platform to adjust the front vertical plane in the X, Y and Z dimensions in 0.01 mm increments.Attorney Docket No. 1184.

284. WO14. The three-dimensional positional evaluation system of Claim 7, wherein the channel comprises right and left side walls facing each other along at least part of a length of the channel in front of an end wall of the channel.

15. The three-dimensional positional evaluation system of Claim 1, wherein the positioning table comprises a positioning stage that is moveable in the X, Y and Z dimensions using a rotatable knob of respective X, Y and Z micrometers, wherein the positioning table comprises a front plane with the at least one fiducial maker, wherein the Y micrometer extends horizontally off the platform in a rearward direction, behind the front plane, the X micrometer extends horizontally off one side of the platform and the Z micrometer extends vertically above the platform.

16. A radiosurgery system comprising:a radiation system comprising a bore, a table longitudinally translatable into and out of the bore, a head rest coupled to the table with first and second posts on opposing lateral sides of the table;a high-definition motion monitoring (HDMM) system comprising a camera, the camera coupled to the table; anda quality assurance tool comprising a positioning table coupled to a platform and comprising a plurality of actuators moveable in respective X, Y and Z dimensions, wherein the positioning table comprises at least one fiducial marker visible to the camera of the HDMM system, wherein the platform is configured to releasably couple to the head rest and has an upper surface that holds the positioning table while allowing the positioning table to translate in X, Y and Z dimensions relative to the platform.

17. The radiosurgery system of Claim 16, wherein the platform comprises a base with a plurality of apertures and with a plurality of downwardly extending tabs, wherein the plurality of apertures releasably couple to respective upwardly projecting tabs of the head rest and the downwardly extending tabs releasably engage respective apertures in the head rest.

18. The radiosurgery system of Claim 16, wherein the platform has a lateral dimension and a longitudinal dimension and comprises a base that extends laterally and longitudinally, wherein the base merges into a body with right and left side walls that extend longitudinally, wherein the right and left side walls merge into a top of the body forming the upper surface,Attorney Docket No. 1184.

284. WOwherein the body is rectangular and has an open front and rear between the right and left side walls, wherein the base has first and second ends that are spaced apart in the longitudinal dimension, and wherein the body resides closer to the first end of the base than the second end.

19. The radiosurgery system of Claim 18, wherein the first end of the base and a first end of the right and left side walls are in a common laterally extending plane, and wherein the body terminates a longitudinal distance from the second end of the base in a range of about 1 to about 10 inches.

20. The radiosurgery system of Claim 16, wherein the upper surface comprises a channel configured to receive and / or securely couple to a bottom of the positional table.

21. The radiosurgery system of Claim 20, wherein the channel comprises right and left side walls that extend in a front to back direction, and wherein the platform further comprises a front tab residing at or adjacent a front end of the channel.

22. The radiosurgery system of Claim 21, wherein the right and left side walls extend a partial distance of a length of the top of the platform, in front of a rearwardly positioned end wall of the channel, and wherein the front tab faces the end wall.

23. The radiosurgery system of Claim 16, wherein the positioning table comprises a positioning stage that is moveable in the X, Y and Z dimensions using a rotatable knob of respective X, Y and Z micrometers, wherein the positioning table comprises a front plane with the at least one fiducial marker, and wherein the Y micrometer extends horizontally off the platform in a rearward direction, behind the front plane, the X micrometer extends horizontally off one side of the platform and the Z micrometer extends vertically above the platform.

24. The radiosurgery system of Claim 16, wherein the radiosurgery system is a gamma knife radiosurgery system.

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