WO2021061573A1

WO2021061573A1 - Stereotactic frame holder

Info

Publication number: WO2021061573A1
Application number: PCT/US2020/051845
Authority: WO
Inventors: Timur URAKOV
Original assignee: University Of Miami
Priority date: 2019-09-26
Filing date: 2020-09-21
Publication date: 2021-04-01

Abstract

Stereotactic frame holder. In an embodiment, the stereotactic frame holder comprises a shoulder base, a floating base, and a coupling mechanism that couples the shoulder base to the floating base while providing translational control such that a distance between the shoulder base and the floating base can be adjusted. The shoulder base may define a first interior space that is configured to receive at least a neck of a patient, and the floating base may define a second interior space, which is aligned with the first interior space and is configured to receive at least a neck of a patient. In addition, the floating base may be configured to support a stereotactic frame.

Description

STEREOTACTIC FRAME HOLDER

CROSS-REFERENCE TO RELATED APPLICATIONS

[1] This application claims priority to U.S. Provisional Patent App. No. 62/906,637, filed on September 26, 2019, which is hereby incorporated herein by reference as if set forth in full.

BACKGROUND

[2] Field of the Invention

[3] The embodiments described herein are generally directed to a mechanical device for positioning a patient’s head for various medical procedures, and, more particularly, to a device that assists the placement of a stereotactic head frame for medical procedures, such as Gamma Knife radiosurgery, stereotactic lead implantation, brain biopsies, and/or other frame- based operations or treatments.

[4] Description of the Related Art

[5] Stereotactic brain procedures generally use a machine to reach difficult anatomic locations within a patient’s head. To maintain accuracy, a stereotactic reference frame is securely applied to the patient’ s head. This stereotactic frame establishes a connection between the machine and the patient during the stereotactic brain procedure.

[6] The stereotactic frame can be applied to the patient’s head, in advance of a medical procedure, while the patient is fully awake. The patient’s scalp can be infiltrated using local anesthetic. Then, sharp metal pins of the stereotactic frame are typically screwed through the patient’s scalp into the bone of the patient’s skull, thereby securing the stereotactic frame to the patient’s head.

[7] The positioning of the stereotactic frame is important to a given medical procedure. For example, the stereotactic frame must be at an appropriate level to effect the medical procedure. Even minor deviations in height, translation, or angle can negatively affect the result of a medical procedure.

[8] Typically, during positioning, the stereotactic frame is held in place by an assistant while the operator screws in the pins. However, because it is difficult for the assistant to remain completely still, the stereotactic frame may shift in space. This can result in the pins penetrating the patient’s scalp outside the anesthetized areas. In addition, if the resulting position is unsatisfactory for the medical procedure, the stereotactic frame may need to be completely repositioned, requiring new pin entry points into the patient’s scalp. Such situations can result in unnecessary delays to the medical procedure and severe discomfort to the patient. In turn, this can lead to decreases in the number of medical procedures performed and patient satisfaction, thereby diminishing a medical institution’s throughput and overall business.

SUMMARY

[9] Accordingly, a stereotactic frame holder is disclosed. In an embodiment, the stereotactic frame holder comprises: a shoulder base defining a first interior space, wherein the first interior space is configured to receive at least a neck of a patient; a floating base defining a second interior space that is aligned with the first interior space, wherein the second interior space is configured to receive at least a neck of a patient, and wherein the floating base is configured to support a stereotactic frame; and a coupling mechanism that couples the shoulder base to the floating base while providing translational control such that a distance between the shoulder base and the floating base can be adjusted.

[10] The stereotactic frame holder may further comprise a back support coupled to the shoulder base. The back support may be coupled to the shoulder base by a joint that enables a relative angle between the back support and the shoulder base to be adjusted. The joint may comprise a hinge. The back support may comprise a first portion and a second portion, wherein the second portion is angled with respect to the first portion, and wherein the second portion is coupled to the shoulder base. The second portion may be angled at 90° with respect to the first portion.

[11] In an embodiment, the coupling mechanism comprises one or more threaded bolts, and wherein, for each of one or more threaded bolts: the shoulder base comprises a bolt housing that affixes a first end of the threaded bolt to the shoulder base while allowing the threaded bolt to freely rotate; and the floating base comprises a threaded aperture that is configured to engage with the threaded bolt, such that, when the threaded bolt is rotated in a first rotational direction, the distance between the shoulder base and the floating base decreases within a range of distances, and, when the threaded bolt is rotated in a second rotational direction that is opposite the first rotational direction, the distance between the shoulder base and the floating base increases within the range of distances. Each of the one or more threaded bolts may comprise a fixture at a second end that is opposite the first end, such that the fixture prevents the floating base from translating off of the threaded bolt. The coupling mechanism may comprise a plurality of threaded bolts. The plurality of threaded bolts may comprise three threaded bolts. The coupling mechanism may consist of three threaded bolts.

[12] In an embodiment, the coupling mechanism comprises one or more fluid-inflatable pouches affixed on one end to the shoulder base and affixed on an opposite end to the floating base. The one or more fluid-inflatable pouches may comprise a plurality of fluid-inflatable pouches. Each of the plurality of fluid-inflatable pouches may be configured to be inflated or deflated independently from each of the other plurality of fluid-inflatable pouches. The one or more fluid-inflatable pouches may be compressible and expandable to allow movement of the floating base, relative to the shoulder base, along two or more axes.

[13] The floating base may comprise one or more cutouts that are each configured to receive a portion of a stereotactic frame. The portion of the stereotactic frame may be movable, wherein each of the one or more cutouts is configured to enable movement of the respective portion through the cutout. The floating base may comprise one or more recessed platforms in a top surface of the floating base, wherein each of the one or more recessed platforms is configured to receive and support a portion of a stereotactic frame.

[14] The floating base may comprise one or more level gauges, wherein each of the one or more level gauges is configured to indicate whether or not the floating base is level with a ground. The one or more level gauges may comprise a first level gauge oriented along a first axis and a second level gauge that is oriented along a second axis that is orthogonal to the first axis.

BRIEF DESCRIPTION OF THE DRAWINGS

[15] The details of the present invention, both as to its structure and operation, may be gleaned in part by study of the accompanying drawings, in which like reference numerals refer to like parts, and in which:

[16] FIG. 1 illustrates a top and front perspective view of a stereotactic frame holder, according to an embodiment;

[17] FIG. 2 A illustrates a front elevation view of a stereotactic frame holder, according to an embodiment;

[18] FIG. 2B illustrates a side elevation view of a stereotactic frame holder, according to an embodiment;

[19] FIG. 2C illustrates a top plan view of a stereotactic frame holder, according to an embodiment; [20] FIG. 3 A illustrates a top and front perspective view of a stereotactic frame holder applied to a patient, without a stereotactic frame installed, according to an embodiment;

[21] FIG. 3B illustrates a top and back perspective view of a stereotactic frame holder applied to a patient, with a stereotactic frame installed, according to an embodiment; and

[22] FIG. 3C illustrates a top and side perspective view of a stereotactic frame holder applied to a patient, with a stereotactic frame installed, according to an embodiment.

DETAILED DESCRIPTION

[23] After reading this description, it will become apparent to one skilled in the art how to implement the invention in various alternative embodiments and alternative applications. However, although various embodiments of the present invention will be described herein, it is understood that these embodiments are presented by way of example and illustration only, and not limitation. As such, this detailed description of various embodiments should not be construed to limit the scope or breadth of the present invention as set forth in the appended claims.

[24] In an embodiment, a stereotactic frame holder is disclosed. The stereotactic frame holder may be used to facilitate the application of a stereotactic frame to a patient’s head in an efficient and accurate manner, with minimal delay and discomfort to the patient. The stereotactic frame holder can comprise a solid platform to support the stereotactic frame and maintain a desired position of the stereotactic frame with respect to the patient while the pins of the stereotactic frame are secured to the patient’s head. The platform may be shaped so that it can be positioned around the patient’ s neck. The stereotactic frame may fit onto the platform in a manner that prevents the stereotactic frame from sliding around. Once secured to the patient’s head, the stereotactic frame may provide a stable system for performing various medical procedures, such as Gamma Knife radiosurgery, stereotactic lead implantation, brain biopsies, and other frame-based operations or treatments. Thus, the disclosed stereotactic frame holder may provide a reliable and stable support for application of a stereotactic frame, while reducing application time and error and enabling single-operator application of the frame.

[25] 1. System

[26] FIG. 1 illustrates a top and front perspective view of a stereotactic frame holder 100 for improved placement of a stereotactic frame, and FIG. 2A-2C illustrate a front elevation view, side elevation view, and top plan view of the stereotactic frame holder 100, respectively, according to an embodiment. In an embodiment, stereotactic frame holder 100 comprise a back support 110, a shoulder base 120, a joint 130 that connects back support 110 to shoulder base 120, a floating base 140, and a translational coupling mechanism 150 that connect shoulder base 120 to floating base 140 while enabling translational movement of floating base 140 with respect to shoulder base 120.

[27] In an embodiment, back support 110 comprises a first portion 112 and a second portion 114. First portion 112 and second portion 114 may be constructed from the same material (e.g., as a single integral piece) or may be constructed from different materials and/or as two separate pieces that are joined together via any standard joinder mechanism (e.g., adhesive, screws, etc.). First portion 112 and second portion 114 may be angled at an angle Q with respect to each other. As an example, angle Q may be 90°, such that first portion 112 and second portion 114 are orthogonal to each other. However, angle Q may be any suitable angle, including an angle less than 90° or an angle greater than 90°. Angle Q may be fixed. Alternatively, back support 110 may comprise a joint (e.g., hinge, flexible material, etc.) between first portion 112 and second portion 114, such that first portion 112 and second portion 114 may be moved relative to each other, in order to set angle Q to any angle within a range of possible angles.

[28] In an embodiment, shoulder base 120 comprises a generally U-shaped first platform having a pair of arms defining a first interior space 122 spanning between the pair of arms and open through the front of shoulder base 120. The profile of first interior space 122 may have a size and shape that are configured to receive necks of varying size. Thus, shoulder base 120 may be configured to extend from back support 110 over a patient’s shoulders, with the patient’s neck between the pair of arms of the generally U-shaped first platform, to provide a stable base for floating base 140.

[29] It should be understood that shoulder base 120 may, directly or indirectly, rest upon the patient’s shoulders, such that the patient’s shoulders provide stability to shoulder base 120. Alternatively, shoulder base 120 could be supported by a solid supporting structure. Such a structure may comprise a floor-held support, such as a bed frame of the patient’s hospital bed or another system in contact with the ground, a wall-mounted support, a ceiling-mounted support, and/or the like. In this case, shoulder base 120 may be attached to the supporting structure via any suitable attachment mechanism, such as a flexible or adjustable arm that holds shoulder base 120 in place, while enabling the orientation of shoulder base 120, relative to the supporting structure, to be adjusted as needed or desired.

[30] In an embodiment, back support 110 is attached to shoulder base 120 by a joint 130. Joint 130 may comprise one or more hinges (e.g., one hinge, two hinges, three hinges, four hinges, etc.), flexible material, and/or the like. Joint 130 may comprise a single component or a plurality of components. For example, joint 130 could comprise a plurality of hinges spaced equidistantly apart, with one side of each hinge attached to an edge surface of back support 110 and the other side of each hinge attached to the adjacent edge surface of shoulder base 120. In any case, joint 130 enables angular adjustments between back support 110 and shoulder base 120, such that the angle of back support 110 to shoulder base 120 may be moved or set to any angle within a range of possible angles. The range of angles may be from 0° (e.g., such that second portion 114 of back support 110 is in the same plane as shoulder base 120) to any suitable maximum value. However, it should be understood that the range of angles does not need to (but may) extend beyond those which would allow shoulder base 120 to comfortably rest on a patient’s shoulders while back support 110 supports the patient’s back.

[31] In an embodiment, floating base 140 comprises a generally U-shaped second platform having a pair of arms defining a second interior space 142 spanning between the pair of arms and open through the front of floating base 140. The profile of second interior space 142 may have a size and shape that are configured to receive necks and/or heads of varying size. Thus, floating base 140 may be configured to extend around a patient’s neck and/or head, with the patient’s neck or head between the pair of arms of the generally U-shaped second platform, to provide a stable base for a stereotactic reference frame.

[32] Second interior space 142 may sized similarly to, and be coincident with, first interior space 122, such that, together, first interior space 122 and second interior space 142 are configured to receive the neck and/or head of a patient. In general, second interior space 142 can be aligned with first interior space 122, such that shoulder base 120 and floating base 140 can be slid together around a patient’s neck and/or head (e.g., from the rear of the patient), and/or over the patient’s neck and head from the top.

[33] Floating base 140 may comprise one or more cutouts 146. In other words, the profile of second interior space 142 may protrude into floating base 140 or the inner profile of floating base 140 may protrude into second interior space 142 to form cutout(s) 146. Each cutout 146 may be sized and shaped to receive or accommodate a portion or component of a stereotactic frame. For instance, each cutout 146 may enable a portion of the stereotactic frame to pass through floating base 140 at a periphery of second interior space 142. Thus, such a portion of the stereotactic frame may be mounted or rest on shoulder base 120 beneath floating base 140 and/or float above shoulder base 120. In the illustrated embodiment, floating base 140 comprises two cutouts 146A and 146B. However, it should be understood that floating base 140 may consist of any number of cutouts 146, as dictated by the stereotactic frames which it is designed to support, including zero cutouts 146, one cutout 146, three cutouts 146, four cutouts 146, and so on and so forth.

[34] Additionally or alternatively, floating base 140 may comprise one or more recessed platforms 148. Each recessed platform 148 may comprise a partial cutout in a vertical direction through the top surface of floating base 140. Each recessed platform 148 may be sized and shaped to receive or accommodate and support a portion or component of a stereotactic frame. In other words, each recessed platform 148 enables a portion of the stereotactic frame to be supported along both its vertical and horizontal axes. For example, the undersurface of the stereotactic frame may comprise a pattern of protrusions that match and snugly engage with the pattern of recessed platforms 148. Thus, the set of recessed platforms 148 may be designed to engage with the undersurface of the stereotactic frame. In the illustrated embodiment, floating base 140 comprises four recessed platforms 148A, 148B, 148C, and 148D. However, it should be understood that floating base 140 may consist of any number of recessed platforms 148, as dictated by the stereotactic frames which it is designed to support, including zero recessed platforms 148, one recessed platform 148, two recessed platforms 148, three recessed platforms 148, five recessed platforms 148, and so on and so forth.

[35] In addition, in the illustrated embodiment, two recessed platforms 148A and 148B are positioned near the distal end of each arm of floating base 140, whereas two recessed platforms 148C and 148D are positioned near the proximal end of each arm of floating base 140, such that each arm comprises a pair of distal and proximal recessed platforms 148 adjacent to second interior space 142. However, it should be understood that floating base 140 may comprise different patterns of recessed platforms 148, as dictated by the undersurface of the stereotactic frames which floating base 140 is designed to support.

[36] Notably, in an embodiment which comprises both cutout(s) 146 and recessed platform(s) 148, portions of the stereotactic reference frame may be supported by both shoulder base 120 (e.g., through cutout(s) 146) and by floating base 140 (e.g., by being seated within recessed platform(s) 148 and/or on the top surface of floating base). For example, a first portion of the stereotactic reference frame may pass through a cutout 146 and be supported by shoulder base 120 (e.g., on a top surface of shoulder base 120 or within a recessed platform within shoulder base 120), while a second portion of the stereotactic reference frame is seated within a recessed platform 148.

[37] In use, floating base 140 may “float” above shoulder base 120 by virtue of translational coupling mechanism 150. Coupling mechanism 150 couples floating base 140 to shoulder base 120 while allowing translational movement between floating base 140 and shoulder base 120. Translational movement refers to movement that increases or decreases the distance between floating base 140 and shoulder base 120.

[38] In the illustrated embodiment, coupling mechanism 150 comprises a plurality of coupling mechanisms 150A, 150B, and 150C. While three coupling mechanisms 150A-150C are illustrated, coupling mechanism 150 could consist of any number of coupling mechanisms, including, for example, one coupling mechanism, two coupling mechanisms, four coupling mechanisms, and so on and so forth. In an embodiment, each coupling mechanism 150 comprises a long, threaded bolt that is affixed to a corresponding bolt housing 124 in shoulder base 120 and is threaded through a corresponding threaded aperture 144 through floating base 140. In the illustrated embodiment, coupling mechanism 150A comprises a threaded bolt that is threaded through aperture 144A and affixed to bolt housing 124A, coupling mechanism 150B comprises a threaded bolt that is threaded through aperture 144B and affixed to bolt housing 124B, and coupling mechanism 150C comprises a threaded bolt that is threaded through aperture 144C and affixed to bolt housing 124C.

[39] Each bolt housing 124 may affix a corresponding threaded bolt of coupling mechanism 150 to shoulder base 120 while enabling the threaded bolt to freely rotate, within bolt housing 124, around the longitudinal axis of the threaded bolt. For example, each threaded bolt may comprise a flange at one end that fits within a corresponding recess of bolt housing 124 and is held in the recess by a cover of bolt housing 124. The cover may comprise a central aperture, such that it can slide over the threaded bolt and be secured over the flange (e.g., via screws that affix the cover to walls of bolt housing 124 encircling the recess), such that the threaded bolt can freely rotate around its longitudinal axis, within the recess of bolt housing 124, but cannot be removed from the recess of bolt housing 124. Thus, the threaded bolt is rotatably anchored within bolt housing 124. In the illustrated embodiment, coupling mechanism 150A comprises a threaded bolt that rotates around its longitudinal axis within bolt housing 124A, coupling mechanism 150B comprises a threaded bolt that rotates around its longitudinal axis within bolt housing 124B, and coupling mechanism 150C comprises a threaded bolt that rotates around its longitudinal axis within bolt housing 124C.

[40] Each threaded aperture 144 may comprise an aperture that extends entirely through floating base 140 from a bottom side to a top side of floating base 140 and is aligned with a corresponding bolt housing 124 in shoulder base 120. Each threaded aperture 144 may further comprise threads that extend around the walls of the aperture from the bottom side to the top side of the aperture. These threads are configured in size and shape to mate with corresponding threads around the outside of the threaded bolt of each coupling mechanism 150. Thus, each threaded bolt can translate through a corresponding threaded aperture 144 via rotation. It should be understood that as a threaded bolt translates through a threaded aperture 144 in a first direction, the length of the threaded bolt on the bottom side of floating base 140 will decrease as the length of the threaded bolt on the top side of floating base 140 increases, and, as the threaded bolt translates through a threaded aperture 144 in a second direction that is opposite to the first direction, the length of the threaded bolt on the bottom side of floating base 140 will increase as the length of the threaded bolt on the top side of floating base 140 decreases. In the illustrated embodiment, coupling mechanism 150A comprises a threaded bolt that translates through a threaded aperture 144A that is aligned with bolt housing 124A, coupling mechanism 150B comprises a threaded bolt that translates through a threaded aperture 144B that is aligned with bolt housing 124B, and coupling mechanism 150C comprises a threaded bolt that translates through a threaded aperture 144C that is aligned with bolt housing 124C.

[41] Thus, each coupling mechanism 150 comprises a threaded bolt that rotates within a corresponding bolt housing 124 in shoulder base 120 to translate through a corresponding threaded aperture 144 in floating base 140. Because the threaded bolt is affixed to bolt housing 124, it will not move along its longitudinal axis when it is rotated. Rather, the engagement of threaded aperture 144 with the threads of the threaded bolt will force floating base 140 to translate closer to or farther from shoulder base 120, depending on the direction of rotation. For example, if the threaded bolt is rotated in one direction (e.g., clockwise or counterclockwise), floating base 140 will move closer to shoulder base 120 (i.e., decreasing the distance between floating base 140 and shoulder base 120). Conversely, if the threaded bolt is rotated in a second, opposite direction (e.g., counterclockwise or clockwise), floating base 140 will move farther from shoulder base 120 (i.e., increasing the distance between floating base 140 and shoulder base 120). Thus, the distance between floating base 140 and shoulder base 120 may be finely adjusted, by rotating the threaded bolts, to accommodate different head and/or neck dimensions, different stereotactic frames, and/or different medical procedures. It should be understood that the distance between floating base 140 and shoulder base 120 may be adjusted to any distance within a range of distances defined by the length of the threads on the threaded bolts. This range of distances may start at essentially zero (i.e., floating base 140 is in close contact with shoulder base 120) and go to any distance that is suitable for a particular stereotactic frame and/or medical procedure (e.g., the maximum height, from an average or largest patient’s shoulders, at which a stereotactic reference frame would be practically mounted for a medical procedure). [42] In an embodiment, each coupling mechanism 150 may comprise a fixture (e.g., knob, stopper, etc.) on the end of the threaded bolt that is opposite the end of the threaded bolt affixed to bolt housing 124. This fixture can be used to rotate the threaded bolt and/or to prevent floating base 140 from translating off of the unaffixed end of the threaded bolt.

[43] In an alternative embodiment, coupling mechanism 150 could comprise one or more fluid-inflatable pouches (not shown) positioned between, and affixed on its opposing ends to, shoulder base 120 and floating base 140. Such fluid-inflatable pouch(es) may be used in place of the threaded bolts described above or in addition to the threaded bolts described above, to increase or decrease the distance between shoulder base 120 and floating base 140. Specifically, each fluid-inflatable pouch may be configured to be inflated (e.g., by introducing a fluid, such as air, into an interior of the pouch) and deflated (e.g., by extracting a fluid, such as air, from the interior of the pouch). Since the fluid-inflated pouch(es) are positioned between and affixed to shoulder base 120 and floating base 140, when the fluid-inflated pouch(es) are inflated, they will push floating base 140 farther from shoulder base 120, and when the fluid- inflated pouch(es) are deflated, they (or gravity) will pull floating base 140 closer to shoulder base 120. Thus, the distance between shoulder base 120 and floating base 140 can be adjusted to any distance within a range of distances defined by the compressibility and extendibility of the fluid-inflatable pouch(es) (i.e., the minimum and maximum heights of the pouch(es)). Similarly to the threaded bolts, the fluid-inflatable pouch(es) enable adjustment of the distance between shoulder base 120 and floating base 140.

[44] The fluid-inflatable pouch(es) may be adjustable in two or three dimensions to enable the distance between shoulder base 120 and floating base 140 to be adjusted in both the vertical and horizontal directions and/or to enable the angle between shoulder base 120 and floating base 140 to be adjusted. For example, coupling mechanism 150 may comprise a plurality of fluid-inflatable pouches that are each configured to be inflated or deflated independently from each of the other plurality of fluid-inflatable pouches. Thus, for example, the front of floating base 140 may be rotated downward (e.g., by inflating a rear pouch attached to the rear surfaces of shoulder base 120 and floating base 140 to a greater height than side pouches attached to the arms of shoulder base 120 and floating base 140) or upward (e.g., by inflating a rear pouch attached to the rear surfaces of shoulder base 120 and floating base 140 to a shorter height than side pouches attached to the arms of shoulder base 120 and floating base 140), so that it is not parallel with shoulder base 120. As another example, the front of floating base 140 may be translated more frontward with respect to shoulder base 120 (e.g., in a parallel plane, if no angle exists between shoulder base 120 and floating base 140, or in an intersecting plane, if an angle exists between shoulder base 120 and floating base 140), more rearward with respect to shoulder base 120, and/or laterally with respect to shoulder base 120, due to the flexibility of the fluid-inflatable pouch(es) (e.g., when not fully inflated).

[45] In an embodiment, stereotactic frame holder 100 may comprise one or more level gauges 149 that are visible from a top and/or side of stereotactic frame holder 100. Each level gauge 149 may comprise any known method for indicating an angle with respect to the ground. For example, each level gauge 149 may comprise a transparent (e.g., glass, plastic, etc.) tube containing a bubble (e.g., air bubble) within a liquid (e.g., ethanol). The transparent tube may comprise one or more markings that, when viewed in conjunction with the bubble, indicate an angle of the transparent tube with respect to the ground. It should be understood that a position of the bubble in the exact center of the transparent tube typically indicates that the longitudinal axis of the transparent tube is parallel to the ground.

[46] In the illustrated embodiment, stereotactic frame holder 100 comprises two level gauges 149 A and 149B embedded in or attached to the top and in a rear corner of floating base 140. However, in alternative embodiments, stereotactic frame holder 100 may consist of any number of level gauges 149, including one level gauge 149, three level gauges 149, four level gauges 149, five level gauges 149, and so on and so forth. In addition, level gauge(s) 149 could all be positioned on a different component than floating base 140 (e.g., on shoulder base 120), or could be spread across different components (e.g., one or more level gauges 149 on floating base 140 and one or more level gauges 149 on shoulder base 120). However, it should be understood that the placement of level gauge(s) 149 on floating base 140 may be preferable, since the stereotactic frame will be mounted on floating base 140, such that it is generally most advantageous for floating base 140 to be precisely positioned via level gauges 149. Specifically, when positioning stereotactic frame holder 100 around a patient’s head, an operator may view level gauge(s) 149 to level floating base 140 so that it is substantially parallel to the ground. While some operators may find this helpful, others may not. Thus, it should be understood that level gauges 149 could be omitted.

[47] Different level gauges 149 may be oriented along different axes. For example, in the illustrated embodiment, level gauge 149A is oriented along a first axis, and level gauge 149B is oriented along a second axis that is orthogonal to the first axis. This enables the precise orientation of floating base 140, with respect to the ground, in at least two different axes, and generally facilitates positioning of floating base 140 in a plane that is parallel to the ground or at a precise angle with respect to the ground. [48] 2. Application

[49] FIG. 3 A illustrates a top and front perspective view of stereotactic frame holder 100 applied to a patient 200, without a stereotactic frame 300 installed, FIG. 3B illustrates a top and back perspective view of stereotactic frame holder 100 applied to patient 200, with stereotactic frame 300 installed, and FIG. 3C illustrates a top and side perspective view of stereotactic frame holder 100 applied to patient 200, with stereotactic frame 300 installed, according to an embodiment.

[50] As illustrated in FIG. 3 A, stereotactic frame holder 100 may be applied to a patient 200 by sliding stereotactic frame holder 100 around the neck 220 of patient 200 from a rear of patient 200, such that neck 220 is positioned within first interior space 122 and second interior space 142. Shoulder base 120 may rest directly (e.g., with direct contact between the undersurface of shoulder base 120 and the patient’s shoulders 210 or garment) or indirectly (e.g., with underpadding) on the shoulders 210 of patient 200. The angle of back support 110, relative to shoulder base 120, may be adjusted via hinge 130, to comfortably support patient 200 in the necessary or desired position (e.g., an inclined supine position with head and shoulders elevated). As illustrated, padding (e.g., a pillow, foam, etc.) may be placed between the patient’s back and back support 110 for added comfort and support.

[51] The distance and/or angle between floating base 140 and shoulder base 120 may be adjusted and/or the angle between floating base 140 and the ground may be adjusted, using coupling mechanism 150 and/or by adjusting the position of patient 200. For example, an operator may utilize level gauges 149 to precisely position floating base 140 so that it is level with (i.e., parallel to) the ground. The operator may also adjust the distance between shoulder base 120 and floating base 140, using coupling mechanism 150 (e.g., by rotating one or more threaded bolts), until floating base 140 is at the correct position around the patient’s neck 220 or head 230 to accommodate the stereotactic frame at the proper height for the desired medical procedure.

[52] As illustrated in FIGS. 3B and 3C, a stereotactic frame 300 may be mounted on stereotactic frame holder 100. For instance, portions of stereotactic frame 300 may be seated within cutouts 146 and/or recessed platforms 148, such that various portions of stereotactic frame 300 are supported by floating base 140 and, in some embodiments, shoulder base 120 as well. Collectively, cutouts 146 and/or recessed platforms 148 can function to align stereotactic frame 300 within stereotactic frame holder 100, for example, by providing a particular pattern of features that engage with a matching pattern of features on stereotactic frame 300 (e.g., on the underside of stereotactic frame 300). It should be understood that the pattern of features on floating base 140 may be designed to accommodate a single type (e.g., model) of stereotactic frame 300 or a plurality of different types of stereotactic frame 300. In embodiments which accommodate a plurality of different types of stereotactic frame 300, it is not necessary for every single feature of floating base 140 to engage with a corresponding feature on every type of stereotactic frame 300. In other words, the pattern of features on a given type of stereotactic frame 300 may engage with a subset of the pattern of features on floating base 140 and/or the pattern of features on floating base 140 may engage with a subset of the pattern of features on one or more types of stereotactic frame 300.

[53] In the illustrated embodiment, stereotactic frame 300 comprises a reference frame 310 and one or more posts 320. Cutouts 146 and/or recessed platforms 148 may be configured in size and shape to receive reference frame 310 and/or posts 320. For example, protrusions on the underside of reference frame 310 may engage with recessed platforms 148 in floating base 140 to prevent, frontward, rearward, and lateral movement of reference frame 310 with respect to floating base 140. In addition, posts 320 may pass through cutouts 146 in floating base 140. Notably, posts 320 may move (e.g., along a vertical axis) with respect to reference frame 310. Advantageously, cutouts 146 enable the bottom portions of posts 320 to be moved below the plane of floating base 140. Thus, an operator may freely move posts 320 of stereotactic frame 300 to the appropriate positions for the desired medical procedure. For example, the operator may slide posts 320 up or down within cutouts 146, to achieve the necessary alignment with the patient’s head 230.

[54] In summary, stereotactic frame holder 100 receives and maintains the position of stereotactic frame 300 with respect to the patient’s head 230, while enabling stereotactic frame 300 to be freely operated and coupled to the patient’s head 230. Notably, because stereotactic frame 300 is supported and held in position by stereotactic frame holder 100, stereotactic frame 300 may be operated by a single operator.

[55] The above description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles described herein can be applied to other embodiments without departing from the spirit or scope of the invention. Thus, it is to be understood that the description and drawings presented herein represent a presently preferred embodiment of the invention and are therefore representative of the subject matter which is broadly contemplated by the present invention. It is further understood that the scope of the present invention fully encompasses other embodiments that may become obvious to those skilled in the art and that the scope of the present invention is accordingly not limited.

[56] Combinations, described herein, such as “at least one of A, B, or C,” “one or more of A, B, or C,” “at least one of A, B, and C,” “one or more of A, B, and C,” and “A, B, C, or any combination thereof’ include any combination of A, B, and/or C, and may include multiples of A, multiples of B, or multiples of C. Specifically, combinations such as “at least one of A, B, or C,” “one or more of A, B, or C,” “at least one of A, B, and C,” “one or more of

A, B, and C,” and “A, B, C, or any combination thereof’ may be A only, B only, C only, A and

B, A and C, B and C, or A and B and C, and any such combination may contain one or more members of its constituents A, B, and/or C. For example, a combination of A and B may comprise one A and multiple B’s, multiple A’s and one B, or multiple A’s and multiple B’s.

Claims

CLAIMS What is claimed is:

1. A stereotactic frame holder comprising: a shoulder base defining a first interior space, wherein the first interior space is configured to receive at least a neck of a patient; a floating base defining a second interior space that is aligned with the first interior space, wherein the second interior space is configured to receive at least a neck of a patient, and wherein the floating base is configured to support a stereotactic frame; and a coupling mechanism that couples the shoulder base to the floating base while providing translational control such that a distance between the shoulder base and the floating base can be adjusted.

2. The stereotactic frame holder of Claim 1, further comprising a back support coupled to the shoulder base.

3. The stereotactic frame holder of Claim 2, wherein the back support is coupled to the shoulder base by a joint that enables a relative angle between the back support and the shoulder base to be adjusted.

4. The stereotactic frame holder of Claim 3, wherein the joint comprises a hinge.

5. The stereotactic frame holder of Claim 2, wherein the back support comprises a first portion and a second portion, wherein the second portion is angled with respect to the first portion, and wherein the second portion is coupled to the shoulder base.

6. The stereotactic frame holder of Claim 5, wherein the second portion is angled at 90° with respect to the first portion.

7. The stereotactic frame holder of Claim 1, wherein the coupling mechanism comprises one or more threaded bolts, and wherein, for each of one or more threaded bolts: the shoulder base comprises a bolt housing that affixes a first end of the threaded bolt to the shoulder base while allowing the threaded bolt to freely rotate; and the floating base comprises a threaded aperture that is configured to engage with the threaded bolt, such that, when the threaded bolt is rotated in a first rotational direction, the distance between the shoulder base and the floating base decreases within a range of distances, and, when the threaded bolt is rotated in a second rotational direction that is opposite the first rotational direction, the distance between the shoulder base and the floating base increases within the range of distances.

8. The stereotactic frame holder of Claim 7, wherein each of the one or more threaded bolts comprises a fixture at a second end that is opposite the first end, such that the fixture prevents the floating base from translating off of the threaded bolt.

9. The stereotactic frame holder of Claim 7, wherein the coupling mechanism comprises a plurality of threaded bolts.

10. The stereotactic frame holder of Claim 9, wherein the plurality of threaded bolts comprises three threaded bolts.

11. The stereotactic frame holder of Claim 10, wherein the coupling mechanism consists of three threaded bolts.

12. The stereotactic frame holder of Claim 1, wherein the coupling mechanism comprises one or more fluid-inflatable pouches affixed on one end to the shoulder base and affixed on an opposite end to the floating base.

13. The stereotactic frame holder of Claim 12, wherein the one or more fluid- inflatable pouches comprise a plurality of fluid-inflatable pouches.

14. The stereotactic frame holder of Claim 13, wherein each of the plurality of fluid- inflatable pouches is configured to be inflated or deflated independently from each of the other plurality of fluid-inflatable pouches.

15. The stereotactic frame holder of Claim 12, wherein the one or more fluid- inflatable pouches are compressible and expandable to allow movement of the floating base, relative to the shoulder base, along two or more axes.

16. The stereotactic frame holder of Claim 1, wherein the floating base comprises one or more cutouts that are each configured to receive a portion of a stereotactic frame.

17. The stereotactic frame holder of Claim 16, wherein the portion of the stereotactic frame is movable, and wherein each of the one or more cutouts is configured to enable movement of the respective portion through the cutout.

18. The stereotactic frame holder of Claim 1, wherein the floating base comprises one or more recessed platforms in a top surface of the floating base, and wherein each of the one or more recessed platforms is configured to receive and support a portion of a stereotactic frame.

19. The stereotactic frame holder of Claim 1, wherein the floating base comprises one or more level gauges, and wherein each of the one or more level gauges is configured to indicate whether or not the floating base is level with a ground.

20. The stereotactic frame holder of Claim 19, wherein the one or more level gauges comprise a first level gauge oriented along a first axis and a second level gauge that is oriented along a second axis that is orthogonal to the first axis.