Head stabilization systems and methods

Abstract

To provide further improvements relating to a patient head stabilization device for minimally invasive neuro-intervention treatments, and related methods.SOLUTION: A head stabilization system (100) comprises: a head harness (200) configured to engage a head (14) of a patient (10); and a head restraint mechanism (300) configured to be operatively disposed on a patient support device (12). The head harness may be configured to securely engage the head of the patient in a non-traumatic, non-penetrating manner. The head harness may be configured to engage a chin / jaw region, a forehead region, and a rear region of the head of the patient. The head harness is releasably attachable to and at least partially supported by the head restraint mechanism. The head restraint mechanism is configured to stabilize the head harness relative to the patient support device and is configured to selectively allow lateral flexion of a neck of the patient, lateral rotation of the head of the patient, and extension and flexion of the neck of the patient.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is related to and claims priority to U.S. Provisional Patent Application No. 63 / 029,781, filed May 26, 2020, and U.S. Provisional Patent Application No. 63 / 151,926, filed February 22, 2021, the disclosures of which are incorporated herein by reference in their entireties.

[0002] The present disclosure relates generally to patient positioning and stabilization systems, and more particularly to head positioning and stabilization systems, such as for minimally invasive neurointerventional procedures, and related methods. [Background technology]

[0003] The present disclosure contemplates that some medical procedures, such as some surgical procedures and some imaging procedures, require precise positioning and / or stabilization of specific portions of a patient's anatomy. For example, some minimally invasive (e.g., catheter- or endoscope-based) neurointerventional procedures may involve precise imaging of a patient's brain anatomy using several different imaging techniques. Multiple imaging devices (e.g., computed tomography scans (CT), fluoroscopy, etc.) may be used to integrate images for enhanced visualization of the area to be treated. To obtain enhanced images and accurately merge and segment them, the patient's head is stabilized as the images are collected. The present disclosure contemplates that support materials, such as foam pads, towels, and drapes, can be used to stabilize the patient's head during imaging. However, these methods may require sufficient movement of the patient's head to reduce image quality or require repeated imaging. The present disclosure also contemplates that some head immobilization devices typically used in neurosurgical procedures can reliably position the patient's head. However, these devices are typically complex, contain materials that may interfere with imaging, and often contain potentially traumatic components (e.g., skull pins). Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, despite the various advances already made in this field, there remains a need for further improvements related to patient head positioning and stabilization devices, and more particularly, patient head stabilization devices for minimally invasive neurointerventional procedures, and related methods. [Means for solving the problem]

[0005] Generally, a head stabilization system is provided, including a head harness configured to engage a patient's head and a head restraint mechanism configured to be operably disposed on a patient support apparatus, the head harness being removably attachable to and at least partially supported by the head restraint mechanism. The head restraint mechanism is configured to stabilize the head harness relative to the patient support apparatus and to selectively allow lateral flexion of the patient's neck, lateral rotation of the patient's head, and extension and flexion of the patient's neck. The head restraint mechanism may be configured to selectively provide approximately 60 degrees of lateral flexion of the patient's neck left and right for a total of approximately 120 degrees of flexion of the patient's neck. The head restraint mechanism may be configured to selectively provide approximately 120 degrees of lateral rotation of the patient's head left and right for a total of approximately 240 degrees of rotation of the patient's head. The head restraint mechanism may be configured to selectively provide approximately 50 degrees of neck extension and approximately 50 degrees of neck flexion for a total of approximately 100 degrees of extension and flexion of the patient's neck.

[0006] The head stabilization system can be used with multiple imaging devices (e.g., computerized tomography scan (CT), magnetic resonance imaging (MRI), fluoroscopy, etc.). The head harness, head restraint mechanism, and other components of the head stabilization system can be constructed substantially from materials that do not generally interfere with medical imaging procedures. The head harness and head restraint mechanism may be constructed substantially from non-metallic materials. In some embodiments, the head harness and head restraint mechanism can be configured to stabilize the patient's head with the patient in a generally supine position.

[0007] The head harness of the head stabilization system may be configured to securely engage the patient's head in a non-traumatic and non-penetrating manner. The head harness may be configured to engage the chin / jaw region, the forehead region, and the rear region of the patient's head. The head harness may include a halo portion configured to engage the forehead region. The halo portion may include a right halo strap configured to extend anteriorly and posteriorly along the patient's head, a left halo strap configured to extend anteriorly and posteriorly along the patient's head, and a halo adjustment mechanism coupled to the right and left halo straps. The halo adjustment mechanism may be configured to adjust the halo portion to fit the patient's head. The halo adjustment mechanism may further include a right halo hinge coupled to the right halo strap and a left halo hinge coupled to the left halo strap. The head harness may include a chin strap portion configured to engage the chin / jaw region. The head harness may further include a right halo stabilizer connecting the chin strap portion to the right halo strap and a left halo stabilizer connecting the chin strap portion to the left halo strap. The right halo stabilizer may include a right halo stabilizer halo strap portion connected to the right halo strap and a right halo stabilizer chin strap portion connected to the chin strap. The right halo stabilizer halo strap portion may be releasably secured to the right halo stabilizer chin strap portion by a releasable right halo strap catch operable by a right halo strap actuator. The right halo strap actuator may include a right halo strap release button that, when pressed, releases the right halo stabilizer chin strap portion from the right halo stabilizer halo strap portion. The left halo stabilizer may include a left halo stabilizer halo strap portion connected to the left halo stabilizer and a left halo stabilizer chin strap portion connected to the chin strap. The left halo stabilizer halo strap portion may be releasably secured to the left halo stabilizer chin strap portion by a releasable left halo strap catch operable by a left halo strap actuator.The left halo strap actuator may include a left halo strap release button that, when pressed, releases the left halo stabilizer chin strap portion from the left halo stabilizer halo strap portion.

[0008] The head harness may include a rear support portion configured to engage a rear region of the patient's head. The rear support portion may include a generally annular ring configured to be centrally positioned on the rear region of the patient's head. The rear support portion may be connected to the right halo strap and the left halo strap.

[0009] In alternative or additional aspects, the head harness may include one or more radiopaque markings, which may, for example, facilitate alignment of imaging equipment.

[0010] The head harness may include a head restraint portion connecting the rear support portion and the halo adjustment mechanism, the head restraint portion configured to extend centrally front-to-rear over the patient's head. The head restraint portion may include a head restraint element disposed on the head restraint strap portion. The head restraint element may include a connection element configured to releasably couple the head harness to the head restraint mechanism. The connection element may include a harness connector housing. The harness connector housing may include a cavity and a slot configured to releasably engage with the head restraint mechanism. The head restraint mechanism may include a harness connector assembly configured to releasably engage with the head restraint element. The harness connector assembly may include a harness connector stopper disposed on a harness connector shaft. The harness connector stopper may be configured to be releasably received within the cavity of the harness connector housing. The harness connector shaft may be configured to be releasably received within the slot of the harness connector housing.

[0011] In some embodiments, the harness connector stopper can include a generally spherical ball and the slot in the harness connector housing can include a generally circular opening, and disposing the harness connector stopper within the cavity can include seating the generally spherical ball in the generally circular opening.

[0012] The connecting element may include a latch operable to selectively secure the connector stopper within the cavity, and the latch may be releasable by an actuator. The harness connector assembly and the connecting element may be selectively engageable at a plurality of discrete relative angular positions. The harness connector assembly may include a toothed surface of the harness connector assembly, and the connecting element may include a toothed surface of the connecting element. The toothed surface of the harness connector assembly may be selectively engageable with the toothed surface of the connecting element at a plurality of discrete relative angular positions. The head restraint mechanism may include an arcuate tilt guide that stands substantially vertically, and the head harness may be selectively repositionable substantially vertically relative to the tilt guide. Repositioning the head harness substantially vertically relative to the tilt guide enables extension and flexion of the patient's neck. The tilt guide may be disposed on a pivot arm. The pivot arm may be pivotably connected to the patient support apparatus such that pivoting the pivot arm about a pivot axis enables lateral flexion of the patient's neck. The pivot axis may be substantially perpendicular to an upper surface of the patient support apparatus. The pivot arm may include a swing lock assembly configured to selectively lock the pivot arm in an angular position. The angled guide may be selectively repositionable longitudinally along the pivot arm.

[0013] The head harness can be removably attached to the head restraint mechanism by connecting connection elements of the head harness with a harness connector assembly of the head restraint mechanism. The harness connector assembly can be selectively slidably positioned within a generally vertically oriented angled guide slot of the angled guide. The harness connector assembly can include a harness connector knob operably positioned to selectively secure the harness connector assembly in the angled guide slot. The harness connector knob can be operable to secure the relative angular position of the head harness with respect to the head restraint mechanism.

[0014] The head restraint mechanism may further include a locking pin, and the tilt guide may include a plurality of laterally extending tilt guide through-holes. The harness connector assembly may include a laterally extending harness connector assembly through-hole. The pin may be configured to lock the harness connector assembly in position on the tilt guide by extending the pin through one of the plurality of tilt guides through the holes and the harness connector assembly through the holes.

[0015] The head stabilization system may further include a shoulder restraint configured to engage the patient's shoulder. The shoulder restraint may include a first shoulder restraint and a second shoulder restraint, the first shoulder restraint configured to engage the patient's right shoulder and the second shoulder restraint configured to engage the patient's left shoulder. The shoulder restraint may be selectively movable in at least one of a lateral direction and a longitudinal direction relative to the head restraint mechanism. The shoulder restraint portion may be selectively movable in a lateral direction and a longitudinal direction relative to the head restraint mechanism. The shoulder restraint may include a shoulder restraint connection element operably interposing the shoulder restraint portion and the patient support apparatus. The shoulder restraint portion may include a base, which may be selectively slidably coupled to the shoulder restraint connection element. The shoulder restraint may further include a latch assembly configured to selectively secure the shoulder restraint portion relative to the shoulder restraint connection element. The base may include a longitudinal slot, and the shoulder restraint connection element may include a transverse slot. At least a portion of the latch assembly may extend through the longitudinal slot and the lateral slot, and when in a locked configuration, the latch assembly may operate to secure the shoulder restraint portion relative to the shoulder restraint connection element. In the locked configuration, the latch assembly may compress the base and the shoulder restraint connection element between a housing disposed relative to the base and a locking element disposed relative to the shoulder restraint connection element. In the locked configuration, the latch assembly may be over-centered. The shoulder restraint may also include a shoulder pad disposed thereon. The shoulder restraint may be substantially constructed of a material that generally does not interfere with medical imaging procedures. The shoulder restraint may be substantially constructed of a non-metallic material.

[0016] The head stabilization system may further include a patient support plate assembly, and the patient support plate may be configured to be secured to a patient support apparatus. The patient support apparatus may include an angiography table. The head stabilization system may further include at least one support plate attachment element configured to secure the patient support plate assembly to the patient support apparatus. The at least one support plate attachment element may include at least one of a strap and a clamp. The patient support plate assembly may include at least one support plate assembly attachment element configured to engage with the support plate attachment element. The at least one support plate assembly attachment element may include at least one fastening slot. A head restraint mechanism may be attached to the patient support plate assembly. The head restraint mechanism may be selectively pivotably coupled to the patient support plate assembly by a head restraint mechanism connector. The head restraint mechanism connector may include a connector base attached to the patient support plate assembly and a connector cap extending through a bore through the head restraint mechanism connector. The head restraint mechanism connector may be connectable by rotating the connector cap in a first direction relative to the connector base. The head restraint connector may be releasable by rotating the connector cap relative to the connector base in a second direction, the second direction being opposite to the first direction. The head restraint may include a pivot arm, the pivot arm pivotally coupled to the patient support plate assembly by the head restraint connector. One or more interface surfaces of at least one of the pivot arm and the head restraint connector may include a lubricious material, for example, to facilitate easier movement of the pivot arm by a user. The pivot arm may include a swing lock assembly configured to selectively lock the pivot arm in an angular position, and the patient support plate assembly may include a swing lock engagement element configured to operably engage with the swing lock assembly. The swing lock engagement element may include an edge of the patient support plate assembly. An edge of the patient support plate assembly may include a slot shaped substantially as a radius relative to the head restraint connector, and the slot may include a plurality of teeth.The swing lock assembly may include one or more extendable teeth slidably disposed within the slot, and the one or more extendable teeth may be configured to selectively engage the plurality of teeth in the slot. One or more mating surfaces of at least one of the swing lock assembly and the swing lock engaging element may include a lubricating material.

[0017] The patient support plate assembly may include a patient support plate assembly shoulder restraint connection element configured to engage the shoulder restraint. The patient support plate assembly shoulder restraint connection element may include a retaining element configured to releasably secure the shoulder restraint. The patient support plate assembly shoulder restraint connection element may include a transverse slot configured to receive the shoulder restraint. The retaining element may include an upwardly extending boss configured to releasably secure the shoulder restraint in the slot of the shoulder restraint connection portion of the patient support plate assembly. The patient support plate assembly shoulder restraint connection element may be formed of an elastomeric material. The patient support plate assembly may be substantially constructed of materials that do not generally interfere with medical imaging modalities. The patient support plate assembly may be substantially constructed of non-metallic materials.

[0018] In an alternative or additional aspect, the head stabilization system may include a chest elevator configured to facilitate vertical positioning of the patient's upper torso relative to the patient support apparatus. The chest elevator may include an inflatable membrane configured to be positioned under the patient's upper torso such that inflation of the membrane raises the patient's upper torso and deflation of the membrane lowers the patient's upper torso. The chest elevator may be operably coupled to a source of pressurized air.

[0019] In some embodiments, the head stabilization system may include a patient support plate assembly secured to a patient support apparatus and configured to receive at least a portion of a patient thereon; a head harness configured to engage the patient's head; and a head restraint mechanism disposed on the patient support plate assembly, the head harness removably attachable to the head restraint mechanism and at least partially supported by the head restraint mechanism. The head restraint mechanism may be configured to stabilize the head harness relative to the patient support plate assembly. The head restraint mechanism may be configured to selectively allow lateral flexion of the patient's neck, lateral rotation of the patient's head, and extension and flexion of the patient's neck. The head restraint mechanism may be pivotally disposed on the patient support plate assembly.

[0020] In an alternative or additional aspect, the head stabilization system may further include a first shoulder restraint and a second shoulder restraint disposed on the patient support plate. The first shoulder restraint may be configured to engage a first shoulder of the patient, and the second shoulder restraint may be configured to engage a second shoulder of the patient. The first shoulder restraint and the second shoulder restraint may be repositionable laterally and vertically on the patient support plate assembly. The head stabilization system may further include a chest elevator disposed on the patient support plate and configured to position the patient's upper torso. The patient support plate assembly, head harness, head restraint mechanism, and chest elevator may be substantially constructed of materials that generally do not interfere with medical imaging modalities. The patient support plate assembly, head harness, head restraint mechanism, and chest elevator may be substantially constructed of non-metallic materials.

[0021] In an alternative embodiment, the head stabilization system may include a patient support plate assembly, a head harness, and a head restraint mechanism, and may be configured to stabilize a patient's head while the patient is in a generally supine position. The head harness may be configured to engage the patient's head. The head restraint mechanism may be configured to be operably disposed on a patient support apparatus. The head harness may be removably attachable to and at least partially supported by the head restraint mechanism. The head restraint mechanism may be configured to stabilize the head harness relative to the patient support apparatus. The head restraint mechanism may be configured to selectively enable vertical positioning of the patient's head, rotation of the patient's head, and extension and flexion of the patient's neck. The head harness and head restraint mechanism may be configured to stabilize the patient's head and place the patient in a generally lateral position. The head restraint mechanism may be configured to selectively provide approximately 30 degrees of lateral flexion above and below the patient's neck for a total of approximately 60 degrees of flexion of the patient's neck. The head restraint mechanism may be configured to selectively provide approximately 60 degrees of rotation of the patient's head to the patient's right side and to the patient's left side, for a total of approximately 120 degrees of rotation of the patient's head. The head restraint mechanism may be configured to selectively provide approximately 25 degrees of neck extension and approximately 25 degrees of neck flexion, for a total of approximately 50 degrees of extension and flexion of the patient's neck.

[0022] In some embodiments, the head harness of the head stabilization system can be configured to securely engage the patient's head atraumatically and non-penetratively. The head harness can be configured to engage the chin / chin region, the forehead region, and the posterior region of the patient's head. The head harness can include a halo portion configured to engage the forehead region. The halo portion can include a right halo strap configured to extend anteriorly and posteriorly along the patient's head, a left halo strap configured to extend anteriorly and posteriorly along the patient's head, and a halo adjustment mechanism coupled to the right and left halo straps. The halo adjustment mechanism can be configured to adjust the halo portion to fit the patient's head. The halo adjustment mechanism can further include halo brackets coupled to the right and left halo straps, halo clips coupled to the halo brackets, and halo clamps coupled to the halo clips.

[0023] The head harness may include a chin strap portion configured to engage the chin / jaw region of the patient's head. The head harness may further include a right halo stabilizer connecting the chin strap portion to the right halo strap and a left halo stabilizer connecting the chin strap portion to the left halo strap. The right halo stabilizer may include a right halo stabilizer halo strap portion connected to the right halo strap, a right chin strap end connector connected to the right halo stabilizer chin strap portion, and a right adjustable buckle-type connector connected to the right chin strap end connector and the right chin strap portion. The right chin strap end connector is releasably secured to the right adjustable buckle-type connector by a releasable catch operable by a catch release. The right adjustable buckle-type connector may include a catch release that, when actuated, releases the right halo stabilizer chin strap portion from the right halo stabilizer chin strap portion. The catch release may be configured for one-handed operation.

[0024] The left halo stabilizer may include a left halo stabilizer halo strap portion connected to the left halo strap, a left chin strap end connector connected to the left halo stabilizer chin strap portion, and a left adjustable buckle-type connector connected to the left chin strap end connector and the left chin strap portion. The left chin strap end connector may be releasably secured to the left adjustable buckle-type connector by a releasable catch operable by a catch release. The left adjustable buckle-type connector may include a catch release that, when actuated, releases the left halo stabilizer chin strap portion from the left halo stabilizer chin strap portion. The catch release may be configured for one-handed operation.

[0025] The head harness may further include a rear support portion configured to engage with the rear region. The rear support portion may include a generally annular ring configured to be centrally positioned on the rear region of the patient's head. The rear support portion may be connected to the right halo strap and the left halo strap. The head harness may further include a head restraint portion connecting the rear support portion and the halo adjustment mechanism, the head restraint portion configured to extend centrally over the patient's head. The head restraint portion may include a head restraint element disposed on the head restraint strap portion. The head restraint element may include a connection element configured to releasably couple the head harness to the head restraint mechanism. The connection element may include a harness connector housing. The harness connector housing may include a cavity and a slot configured to releasably engage with the head restraint mechanism. The head restraint mechanism may include a harness connector assembly configured to releasably engage with the head restraint element.

[0026] In an alternative or additional aspect, the harness connector assembly may include a harness connector disposed on a harness connector shaft, the harness connector configured to be releasably received within a cavity of the harness connector housing. The connection element may include a latch operable to selectively secure the harness connector within the cavity, the latch being releasable by an actuator. The actuator may be configured for one-handed operation.

[0027] The harness connector assembly and the connecting element may be selectively engageable at a plurality of discrete relative angular positions. The head restraint mechanism may include an arcuate tilt guide oriented generally horizontally. The head harness may be selectively repositionable generally horizontally relative to the tilt guide. Repositioning the head harness generally horizontally relative to the tilt guide allows extension and flexion of the patient's neck.

[0028] The head harness can be removably attached to the head restraint mechanism by connecting connection elements of the head harness with a harness connector assembly of the head restraint mechanism. The harness connector assembly can be selectively slidably positioned within a generally horizontally oriented tilt guide slot of the tilt guide. The harness connector assembly can include a harness connector knob operatively positioned to selectively secure the harness connector assembly in the tilt guide slot. The harness connector knob can be operable to fix a relative angular position of the head harness with respect to the head restraint mechanism. The tilt guide can be positioned on a vertical support, the tilt guide adjustably connected to the patient support apparatus to provide vertical positioning of the patient's head by positioning the tilt guide along a vertical axis. The vertical axis can be substantially perpendicular to an upper surface of the patient support apparatus. The vertical support can include a connector assembly configured to selectively secure the tilt guide vertically relative to the patient support apparatus. The tilt guide can be selectively repositioned vertically along the vertical support.

[0029] In an alternative or additional aspect, the head restraint mechanism may be coupled to the patient support plate assembly by a head restraint mechanism connector. The head restraint mechanism connector may include a head restraint connector base attached to the patient support plate assembly, a vertical support mounting plate, and a plurality of locking devices. The vertical support may be coupled to the vertical support mounting plate. The head restraint mechanism may be selectively positioned horizontally relative to the patient support plate assembly by positioning the vertical support mounting plate relative to the head restraint connector base. The head restraint mechanism may be secured relative to the patient support plate assembly by operating the locking device. The head restraint mechanism connector may include an incremental adjustment mechanism. The vertical support mounting plate may include a plurality of teeth, and the head restraint connector base may include a plurality of teeth configured to selectively engage the teeth of the vertical support mounting plate.

[0030] The head stabilization system may further include a torso pad configured to facilitate vertical positioning of the patient's upper torso relative to the patient support apparatus. The torso pad may include an inflatable membrane configured to be positioned under the patient's upper torso such that inflation of the inflatable membrane raises the patient's upper torso and deflation of the inflatable membrane lowers the patient's upper torso. The torso pad may be operably coupled to a source of pressurized air.

[0031] The head stabilization system may further include a neck pad configured to facilitate vertical positioning of the patient's neck relative to the patient support apparatus. The neck pad may include an inflatable membrane configured to be positioned under the patient's neck such that the inflatable membrane is inflated to support the patient's neck. The neck pad may be operably coupled to a source of pressurized air.

[0032] Generally, a method of stabilizing a patient's head is contemplated and may include attaching a head harness to the patient's head, attaching the head harness to a head restraint mechanism, positioning the patient's head, and securing the head restraint mechanism. The method of stabilizing a patient's head may include attaching the head harness to the patient's head while the head harness is disconnected from the head restraint mechanism. The step of attaching the head harness to the head restraint mechanism can be performed with the head harness attached to the patient's head.

[0033] Alternatively, the method for stabilizing a patient's head may include attaching a head harness to a head restraint mechanism, attaching the head harness to the patient's head, positioning the patient's head, and securing the head restraint mechanism. The method for stabilizing a patient's head may include attaching the head harness to the head restraint mechanism and then attaching the head harness to the patient's head. The step of attaching the head harness to the head restraint mechanism may occur before attaching the head harness to the patient's head.

[0034] In some embodiments, a method of stabilizing a patient's head is contemplated, wherein a head restraint mechanism can be configured to stabilize a head harness relative to a patient support apparatus. The method can include placing a patient on the patient support apparatus. The method can include placing the patient on the patient support apparatus in a generally supine position. The head harness can be attached to the patient's head before placing the patient on the patient support apparatus. Alternatively, the head harness can be attached to the patient's head after placing the patient on the patient support apparatus.

[0035] Alternatively, a method for stabilizing a patient's head is contemplated, wherein a head restraint mechanism is configured to be disposed on a patient support plate assembly, and the method may further include attaching the patient support plate assembly to a patient support apparatus. The method may further include attaching the head restraint mechanism to the patient support plate assembly. The method may further include attaching a first shoulder restraint and a second shoulder restraint to the patient support plate assembly. The method may further include installing a chest elevator on the patient support plate assembly. In an alternative or additional aspect, the method may further include installing at least one pad.

[0036] In some embodiments, a method of stabilizing a patient's head is contemplated, wherein attaching a head harness to the patient's head may include positioning a halo portion and a rear support portion to substantially surround the patient's head. The method may further include adjusting the halo portion using a halo adjustment knob. The method may further include positioning a chin strap portion at the chin / jaw region of the patient's head. The method may further include attaching the head harness to the patient's head. The head harness may include at least one halo stabilizer. The at least one halo stabilizer may comprise a halo stabilizer chin strap portion and a halo stabilizer halo strap portion. The method of attaching the head harness to the patient's head may include coupling the halo stabilizer chin strap portion to the halo stabilizer halo strap portion. The method of attaching the head harness to the patient's head may further include securing a head restraint portion extending centrally anteriorly and posteriorly over the crown of the patient's head.

[0037] In some embodiments, the method for stabilizing the patient's head may further include adjusting the first and second shoulder restraints. Adjusting the first and second shoulder restraints may include repositioning at least one of the first and second shoulder restraints to constrain at least one of the lateral and longitudinal directions. Adjusting the first and second shoulder restraints may include at least one of unlocking and locking a latch assembly, the latch assembly being configured to selectively secure at least one of the first and second shoulder restraints. Adjusting the first and second shoulder restraints may include applying a traction force to the patient's neck by applying a force in a generally downward direction to the patient's shoulders.

[0038] In an alternative or additional aspect, a method of attaching a head harness to a head restraint mechanism may include coupling a harness connector housing of the head harness to a harness connector assembly of the head restraint mechanism. The harness connector housing may include a cavity and a slot, and the harness connector assembly may include a harness connector stopper disposed on the harness connector shaft. The method of attaching the head harness to the head restraint mechanism may include disposing the harness connector stopper in the cavity and disposing the harness connector shaft in the slot. The harness connector stopper may include a substantially spherical ball, and the slot may include a substantially circular opening. Disposing the harness connector stopper in the cavity may include seating the substantially spherical ball in the substantially circular opening.

[0039] In some embodiments, a method of stabilizing a patient's head is contemplated, wherein positioning the patient's head can include laterally flexing the patient's neck. The method can include pivoting a head restraint mechanism about an axis substantially perpendicular to a top surface of a patient support apparatus.

[0040] In an alternative or additional aspect, a method of stabilizing a patient's head is contemplated, wherein positioning the patient's head can include rotating the patient's head about a harness connector shaft that connects a head harness to a head restraint mechanism.

[0041] In another embodiment, a method of stabilizing a patient's head is contemplated, wherein positioning the patient's head may include at least one of extending the patient's neck and flexing the patient's neck. The method may include vertically repositioning a harness connector assembly along an arcuate oblique guide. The method may include repositioning the harness connector assembly by slidably repositioning the harness connector assembly along an oblique guide slot. The method may further include securing the harness connector assembly on the oblique guide by installing a locking pin through a laterally extending oblique guide through-hole and a laterally extending harness connector assembly through-hole.

[0042] In some embodiments, a method for stabilizing a patient's head may include securing a head restraint mechanism with the patient's head positioned in one of a desired lateral flexion of the patient's neck, a desired lateral rotation of the patient's head, and a desired neck extension and a desired neck flexion. The method may further include tightening a swing lock assembly. Tightening the swing lock assembly may include engaging one or more extendable teeth associated with the swing lock assembly with a plurality of teeth associated with the swing lock engagement element. The method may further include engaging a radially toothed surface associated with the head harness with a radially toothed surface associated with the head restraint mechanism. The method may further include tightening a harness connector assembly that operably couples the head harness to the head restraint mechanism.

[0043] In alternative or additional aspects, a method of stabilizing a patient's head may include elevating the patient's upper torso using a thoracic elevator. The method of elevating the patient's upper torso may further include at least partially inflating an inflatable membrane of the thoracic elevator. The method may further include lowering the patient's upper torso using the thoracic elevator. The method of lowering the patient's upper torso may further include at least partially deflating an inflatable membrane of the thoracic elevator.

[0044] The method for stabilizing a patient's head may further include administering a procedure to the patient after securing the head restraint mechanism. The method may further include removing a head harness from the patient's head. The method may further include removing the head harness from the head restraint mechanism. The method may further include loosening the head restraint mechanism.

[0045] In the alternative or additional aspect, attaching the head harness to the patient's head may include non-traumatically, non-penetratingly, securely engaging the patient's head with the head harness.

[0046] A method of stabilizing a patient's head is contemplated, and may include the steps of attaching a head harness to the patient's head, attaching the head harness to a head restraint mechanism, positioning the patient's head, and securing the head restraint mechanism. The method of attaching the head harness to the patient's head may be performed while the head harness is disconnected from the head restraint mechanism. The method of attaching the head harness to the head restraint mechanism may be performed with the head harness attached to the patient's head.

[0047] In some embodiments, a method of stabilizing a patient's head is contemplated, wherein the head restraint mechanism can be configured to stabilize a head harness relative to a patient support apparatus. The method may further include placing the patient on the patient support apparatus. The method may include placing the patient on the patient support apparatus in a generally lateral position. The head harness may be attached to the patient's head before placing the patient on the patient support apparatus. Alternatively, the head harness may be attached to the patient's head after placing the patient on the patient support apparatus.

[0048] In some embodiments, a method of attaching a head harness to a patient's head may include positioning a halo portion and a rear support portion to substantially encircle the patient's head. The method may further include adjusting the halo portion using a halo adjustment mechanism. The method may further include positioning a chin strap portion at the chin / chin region of the patient's head. The method may further include coupling a chin strap portion of a halo stabilizer to the chin strap portion. The method may further include securing a head restraint portion extending centrally from front to back over the crown of the patient's head.

[0049] In an alternative or additional aspect, a method of attaching a head harness to a head restraint mechanism may include coupling a harness connector housing of the head harness to a harness connector assembly of the head restraint mechanism. The harness connector housing may include a cavity and a slot, and the harness connector assembly may include a harness connector stopper disposed on the harness connector shaft. The method of attaching the head harness to the head restraint mechanism may include disposing the harness connector stopper in the cavity and disposing the harness connector shaft in the slot.

[0050] In an alternative or additional aspect, a method of positioning a patient's head may include positioning the patient's head vertically, and may further include moving a head restraint mechanism along an axis substantially perpendicular to a top surface of the patient support apparatus.

[0051] In some embodiments, a method of positioning a patient's head may include at least one of extending the patient's neck and flexing the patient's neck. The method may include horizontally repositioning a harness connector assembly along an arcuate oblique guide. The method may further include slidably repositioning the harness connector assembly along an oblique guide slot.

[0052] In some embodiments, a method of stabilizing a patient's head may include positioning the patient's upper torso using a torso pad. The method of positioning the patient's upper torso may further include at least partially inflating an inflatable membrane of the torso pad.

[0053] In an alternative or additional aspect, a method of stabilizing a patient's head may include supporting the patient's neck using a neck pad. The method of supporting the patient's neck may further include at least partially inflating an inflatable membrane of the neck pad.

[0054] A method of manufacturing a head stabilization system may include installing a head restraint mechanism on a patient support plate assembly. The method may further include attaching at least one shoulder restraint. The method may further include attaching the at least one shoulder restraint to the patient support plate assembly. The method may further include installing a chest elevator. Installing the chest elevator may include installing the chest elevator on the patient support plate assembly.

[0055] Alternatively, a method of manufacturing a head stabilization system may include attaching a patient support plate assembly to a patient support apparatus. The method may further include attaching a head restraint mechanism to the patient support plate assembly. The method may further include attaching a torso pad to the patient support plate assembly. The method may further include attaching a neck pad to the patient support plate assembly.

[0056] Additional features, options, or aspects of the present invention will become more apparent by reviewing the detailed description of various exemplary embodiments, which are described in more detail herein, in conjunction with the accompanying drawings of those exemplary embodiments. [Brief explanation of the drawings]

[0057] [Figure 1] FIG. 1 is an isometric view of an exemplary head stabilization system in use on a patient, the patient being positioned in a general supine position. [Figure 2] FIG. 2 is an isometric view of the exemplary head stabilization system shown in FIG. 1. [Figure 3] FIG. 3 is a plan view of the exemplary head stabilization system shown in FIGS. 1 and 2, illustrating lateral placement of the patient's head. [Figure 4] FIG. 3 is a cranial elevation view of the exemplary head stabilization system shown in FIGS. 1 and 2, illustrating rotational positioning of the patient's head. [Figure 5] FIG. 3 is a side elevation view of the exemplary head stabilization system shown in FIGS. 1 and 2, illustrating the extension of the patient's neck. [Figure 6] FIG. 3 is a side elevational view of the exemplary head stabilization system shown in FIGS. 1 and 2, illustrating compression of the patient's neck. [Figure 7] FIG. 1 is an isometric view of an exemplary head harness placed on a patient's head. [Figure 8] FIG. 8 is another isometric view of the exemplary head harness shown in FIG. 7 placed on a patient's head. [Figure 9] FIG. 1 illustrates an isometric view of an exemplary head restraint mechanism. [Figure 10] FIG. 10 is another isometric view of the exemplary head restraint mechanism shown in FIG. [Figure 11] FIG. 10 is a perspective view of the exemplary head restraint mechanism shown in FIG. [Figure 12] FIG. 1 illustrates an isometric view of an exemplary shoulder restraint in a locked configuration. [Figure 13]FIG. 13 is an isometric partial cutaway view of the exemplary shoulder restraint shown in FIG. 12 in an unlocked configuration. [Figure 14] FIG. 13 is another isometric view of the exemplary shoulder restraint shown in FIG. 12 in the locked configuration. [Figure 15] FIG. 1 is an isometric view of an exemplary patient support plate assembly. [Figure 16] FIG. 3 is an isometric view of the exemplary head stabilization system shown in FIGS. 1 and 2 in use on a patient with the head harness disconnected from the head restraint mechanism. [Figure 17] FIG. 10 is an isometric view of another exemplary head restraint mechanism. [Figure 18] FIG. 10 is an isometric view of another exemplary head harness. [Figure 19] FIG. 10 is an isometric view of another exemplary head restraint mechanism. [Figure 20] FIG. 1 is an isometric view of an alternative exemplary head stabilization system in use on a patient positioned generally sideways. [Figure 21] FIG. 21 is an isometric view of the exemplary head stabilization system shown in FIG. 20. [Figure 22] FIG. 22 is a side elevational view of the exemplary head stabilization system shown in FIGS. 20 and 21, illustrating the vertical position of the patient's head. [Figure 23] FIG. 22 is a cranial elevation view of the exemplary head stabilization system shown in FIGS. 20 and 21, illustrating rotational positioning of the patient's head. [Figure 24] FIG. 22 is a plan view of the exemplary head stabilization system shown in FIGS. 20 and 21, illustrating extension of the patient's neck. [Figure 25] FIG. 22 is a top view of the exemplary head stabilization system shown in FIGS. 20 and 21, illustrating flexion of the patient's neck. [Figure 26] FIG. 10 is an isometric view of an alternative exemplary head harness placed on a patient's head. [Figure 26A] FIG. 27 is an exploded view of the exemplary head harness shown in FIG. 26. [Figure 27] FIG. 27 is another isometric view of the exemplary head harness shown in FIG. 26 placed on a patient's head. [Figure 28] FIG. 10 is an isometric view of an alternative exemplary head restraint mechanism. [Figure 29] FIG. 29 is an exploded view of the exemplary head restraint mechanism shown in FIG. 28. [Figure 30] FIG. 29 is an alternative isometric view of the exemplary head restraint mechanism shown in FIG. 28. [Figure 31A] FIG. 10 is an isometric view of an alternative exemplary shoulder restraint. [Figure 31B] FIG. 31B is an alternative isometric view of the exemplary shoulder restraint shown in FIG. 31A. [Figure 32A] FIG. 31C is an isometric view of the exemplary shoulder pad shown in FIGS. 31A and 31B. [Figure 32B] FIG. 32B is another isometric view of the exemplary shoulder pad shown in FIG. 32A. [Figure 33] FIG. 31C is an isometric view of the exemplary shoulder restraint bracket shown in FIGS. 31A and 31B. [Figure 34] FIG. 10 is an isometric view of an alternative exemplary shoulder restraint. [Figure 35] FIG. 35 is an isometric view of the exemplary shoulder restraint shoulder pad shown in FIG. 34. [Figure 36] FIG. 1 is an isometric view of an alternative exemplary head stabilization system in use on a patient positioned in a general supine position. [Figure 37] FIG. 37 is an isometric view of the exemplary head stabilization system shown in FIG. 36. [Figure 38] FIG. 38 is a top view of the exemplary head stabilization system shown in FIGS. 36 and 37, illustrating lateral positioning of the patient's head. [Figure 39] FIG. 38 is a cranial elevation view of the exemplary head stabilization system shown in FIGS. 36 and 37, illustrating rotational positioning of the patient's head. [Figure 40] FIG. 38 is a side elevation view of the exemplary head stabilization system shown in FIGS. 36 and 37, illustrating extension of the patient's neck. [Figure 41] FIG. 38 is a side elevational view of the exemplary head stabilization system shown in FIGS. 36 and 37, illustrating compression of the patient's neck. [Figure 42]FIG. 10 is an isometric view of an alternative exemplary head harness placed on a patient's head. [Figure 43] FIG. 43 is another isometric view of the exemplary head harness shown in FIG. 42 positioned on a patient's head. [Figure 44] FIG. 10 is an isometric view of an alternative exemplary head restraint mechanism. [Figure 45] FIG. 45 is another isometric view of the exemplary head restraint mechanism shown in FIG. 44. [Figure 46] FIG. 46 is an exploded view of the exemplary head restraint mechanism shown in FIGS. 44 and 45. [Figure 47] FIG. 10 is an isometric view of an alternative exemplary patient support plate assembly. [Figure 48] FIG. 48 is an alternative isometric view of the exemplary patient support plate assembly shown in FIG. 47. [Figure 49] FIG. 1 is an isometric view of an alternative exemplary head stabilization system in use on a patient positioned generally sideways. [Figure 50] FIG. 50 is a side elevation view of the exemplary head stabilization system shown in FIG. 49, illustrating the vertical position of the patient's head. [Figure 51] FIG. 50 is a cranial elevation view of the exemplary head stabilization system shown in FIG. 49, illustrating rotational positioning of the patient's head. [Figure 52] FIG. 50 is a plan view of the exemplary head stabilization system shown in FIG. 49, showing extension and flexion of the patient's neck. [Figure 53] FIG. 10 is an isometric view of an alternative exemplary head harness placed on a patient's head. [Figure 54] FIG. 54 is another isometric view of the exemplary head harness shown in FIG. 53 placed on a patient's head. [Figure 55] FIG. 1 is an isometric view of an exemplary head harness placed on a patient's head. [Figure 56] FIG. 54 is another isometric view of the exemplary head harness shown in FIG. 53 placed on a patient's head. [Figure 57] FIG. 1 is an isometric view of an exemplary head harness placed on a patient's head. [Figure 58]FIG. 54 is an alternative isometric view of the exemplary head harness shown in FIG. 53 placed on a patient's head. DETAILED DESCRIPTION OF THE INVENTION

[0058] Exemplary embodiments according to at least some aspects of the present disclosure are described and illustrated below and include devices and methods related to medical procedures. Of course, it will be apparent to those skilled in the art that the embodiments described below are examples and may be reconfigured without departing from the scope and spirit of the present disclosure. It should also be understood that variations of the exemplary embodiments contemplated by those skilled in the art also constitute part of the present disclosure. However, for clarity and accuracy, the exemplary embodiments described below may include optional steps, methods, and features that those skilled in the art should recognize as not being required to fall within the scope of the present disclosure.

[0059] The present disclosure includes, among other things, a patient head stabilization system. Some exemplary embodiments according to at least some aspects of the present disclosure may be used as a patient head positioning and stabilization system for minimally invasive neurointerventional procedures. While this detailed description of exemplary embodiments focuses on minimally invasive neurointerventional procedures, it will be understood that various embodiments according to at least some aspects of the present disclosure may be utilized in connection with other procedures.

[0060] 1 is an isometric view of an exemplary head stabilization system 100 in use on a patient 10, in accordance with at least some aspects of the present disclosure. The head stabilization system 100 is typically positioned on a patient support apparatus, such as the head end of an angiography table 12. The head stabilization system 100 is configured to facilitate various procedures, such as imaging of the patient's head 14 with one or more imaging devices 16, 18 that can be selectively positioned relative to the table 12. Some exemplary embodiments may be used in connection with procedures that include accessing the cerebrospinal fluid space via, for example, a C1-C2 puncture site 48.

[0061] FIG. 2 is an isometric view of an exemplary head stabilization system 100 according to at least some embodiments of the present disclosure. With reference to FIGS. 1 and 2 , the exemplary head stabilization system 100 is generally configured to facilitate desired positioning of a patient's head 14 and / or support and stabilize the patient's head 14 (e.g., immobilize and hold the patient's head 14), such as during a procedure. The exemplary head stabilization system 100 includes a head harness 200 configured to engage the patient's head 14 and a head restraint mechanism 300 to which the head harness 200 is removably attachable. The head restraint mechanism 300 is configured to facilitate positioning and stabilization of the patient's head 14 relative to the table 12 using the head harness 200. The exemplary head stabilization system 100 includes one or more shoulder restraints 400, 402 configured to engage the patient's shoulders 20, 22 and a chest elevator 500 configured to adjust the vertical position of the patient's upper torso 24. The head restraint mechanism 300, shoulder restraints 400, 402, and chest elevator 500 are disposed on a support plate assembly 600. The support plate assembly 600 is secured to the table 12, such as by one or more support plate attachment elements, such as one or more straps 26 and / or clamps 28. In general, the head stabilization system 100 enables the patient's head 14 to be positioned and / or oriented in three-dimensional space relative to the imaging devices 16, 18 and the table 12, and stabilizes the patient's head 14 in a desired position.

[0062] 3-6, an overview of possible positioning of the patient's head 14 facilitated by the head stabilization system 100 is provided to provide context for the following discussion. In general, the exemplary head stabilization system 100 can be positioned and / or secured in any position and / or orientation within any combination of the ranges of motion described with reference to FIGS. 3-6 to position and / or stabilize the patient's head 14 in a desired position, such as for a procedure.

[0063] 3 is a plan view of an exemplary head stabilization system 100 illustrating lateral positioning of a patient's head 14, according to at least some embodiments of the present disclosure. Generally, this articulation of the head restraint mechanism 300 provides lateral flexion of the patient's neck 30 to the left or right, as indicated by arrow 32, in a plane generally parallel to the top surface of the support plate assembly 600. This lateral flexion motion is similar to the movement that occurs when a patient tilts their head to the right or left to place their ear against the shoulder 20, 22 on the same side without rotating the head 14. This exemplary head stabilization system 100 facilitates lateral flexion of approximately 30° left of center and approximately 30° right of center, for a full range of lateral flexion of approximately 60° from extreme left to extreme right.

[0064] FIG. 4 is a head elevation view of an exemplary head stabilization system 100 illustrating rotational positioning of a patient's head 14, according to at least some embodiments of the present disclosure. Generally, this articulation of the head harness 200 relative to the head restraint mechanism 300 provides lateral rotation of the patient's head 14 to the left or right, as indicated by arrow 34, in a plane generally transverse to the upper surface of the support plate assembly 600. As used herein, "transverse" may refer to a relative angular orientation that is not parallel (e.g., perpendicular or diagonal). This movement is generally similar to the movement that occurs when a patient attempts to shake their head 14 from side to side to say "no." This exemplary head stabilization system 100 facilitates lateral rotation of approximately 60° to the left and approximately 60° to the right, for a total range of lateral rotation of approximately 120°.

[0065] 5 and 6 are side elevation views of an exemplary head stabilization system 100 illustrating extension and compression, respectively, of a patient's neck 30, according to at least some embodiments of the present disclosure. Generally, this articulation of the head restraint mechanism 300 provides posterior (i.e., extension) and anterior (i.e., flexion) extension and flexion of the patient's neck 30 in a plane generally perpendicular to the upper surface of the support plate assembly 600, as indicated by arrow 36. These movements generally resemble those that occur when a patient attempts to nod their head 14 up and down to say "yes." This exemplary head stabilization system 100 facilitates approximately 25° of upward neck extension (from neutral) and approximately 25° of downward neck flexion (from neutral), for a total range of approximately 50° of extension and flexion. The position shown in FIG. 5 improves access to the cerebrospinal fluid space via the C1-C2 puncture site 48 and facilitates lateral posterior needle introduction. The position shown in FIG. 6 may improve access to the anterior anatomical structures of the brain. In some cases, it may be advantageous to apply traction to the patient's neck 30. For example, the head restraint 300 (via the head harness 200) may apply a generally upward / cranial force to the patient's head 14, and / or the shoulder restraints 400, 402 may apply a generally downward / caudal force to the patient's shoulders 20, 22. Thus, the patient's neck 30 may be placed in tension in a generally longitudinal direction.

[0066] 7 and 8 are isometric views of an exemplary head harness 200 positioned on a patient's head 14, in accordance with at least some aspects of the present disclosure. The head harness 200 is configured to be secured to the patient's head 14 and to be (e.g., releasably) coupled to a head restraint mechanism 300 ( FIG. 2 ). Generally, the exemplary head harness 200 is configured to engage the patient's head 14 at the chin / chin region 38, the forehead region 40, and the posterior region 42. In some exemplary embodiments, the head harness 200 can be configured to securely engage the patient's head in a non-traumatically, non-penetrating manner (e.g., components of the head harness 200 cannot penetrate the patient's skin).

[0067] The exemplary head harness 200 includes a chin strap portion 202 configured to engage the patient's chin / jaw region 38. The chin strap portion 202 facilitates control of the position of the patient's chin relative to the patient's neck 30. The chin strap portion 202 includes a right chin strap portion 204 and a left chin strap portion 206, which extend forward and downward generally along the patient's mandible and hold a chin pad 208 against the patient's chin / jaw region 38. The chin strap portions 204, 206 may be adjustable, such as by adjustable buckle-type connectors (not shown).

[0068] The exemplary head harness 200 includes a halo portion 210 configured to engage the patient's forehead 40 and the side portions 44, 46 of the patient's head 14. The halo portion 210 includes a right halo strap portion 212 and a left halo strap portion 214. The halo strap portions 212, 214 extend front to back along the patient's head 14. The halo strap portions 212, 214 are coupled at their front to a halo adjustment mechanism 216 that includes a halo adjustment knob 218, a right halo adjustment hinge 220, and a left halo adjustment hinge 222 configured to allow the halo portion 210 to be adjusted to securely fit the individual patient's head 14.

[0069] In the exemplary head harness 200, halo portion 210 is connected to chin strap portion 202 by right halo stabilizer 224 and left halo stabilizer 226. Each halo stabilizer 224, 226 is generally T-shaped with a generally horizontal upper portion attached to a respective halo strap portion 212, 214 and a generally vertical lower portion connected to a respective chin strap portion 204, 206. In this exemplary embodiment, T-shaped stabilizers 224, 226 are substantially rigid, and each halo strap portion 212, 214 is connected to its respective stabilizer 224, 226 by one or more halo fasteners 228 or the like. Chin strap portions 204, 206 are pivotally attached to the lower ends of the vertical portions of halo stabilizers 224, 226 by chin strap fasteners 230 or the like, allowing rotational adjustment for a secure fit to an individual patient's head 14.

[0070] Referring to FIG. 7 , right halo stabilizer 224 includes two detachably connected portions: halo strap portion 232 and chin strap portion 234. Halo strap portion 232 and chin strap portion 234 are secured together by a releasable catch operated by an actuator, such as release button 236. When actuated by a user, release button 236 releases chin strap portion 234 from halo strap portion 232. In some embodiments, button 236 can function as an emergency release, allowing patient 10 to be quickly disconnected from head stabilization system 100. For example, if the patient's airway is compromised, it may be desirable to quickly access the patient's mouth by removing chin strap portion 202 (e.g., by actuating button 236 as a chin strap emergency release). In some embodiments, button 236 may be configured for one-handed operation. Left halo stabilizer 226 is constructed in a substantially similar manner and includes a similar button 237 that provides emergency release of the chin strap.

[0071] The exemplary head harness 200 includes a rear support portion 238, which may be in the form of a generally annular ring configured to be centrally positioned on the rear region 42 of the patient's head 14. The rear support portion 238 is coupled to each of the halo strap portions 212, 214, such that the patient's head 14 is substantially circumscribed by the left halo strap portion 214, the halo adjustment mechanism 216, the right halo strap portion 212, and the rear support portion 238. The rear support portion 238 and the halo adjustment mechanism 216 are also connected by a head restraint portion 240, which extends front to back across the center of the top of the patient's head 14.

[0072] Head restraint portion 240 includes a head restraint strap portion 242 and a head restraint element 244 disposed on head restraint strap portion 242. Head restraint element 244 includes a head restraint strap adjustment knob 246 configured to allow head restraint strap portion 242 to be adjusted to provide a secure fit to an individual patient's head 14.

[0073] The exemplary head harness 200 includes a connection element, such as a harness connector housing 248, configured to releasably couple the head harness 200 to the head restraint mechanism 300. The harness connector housing 248 is disposed on the restraint element 244 and includes a cavity 250, a slot 252, and a toothed surface 254 configured to releasably engage with corresponding components of the head restraint mechanism 300, as described below. The slot 252 extends through a wall 256 that at least partially defines the cavity 250. Additionally, the harness connector housing 248 includes a latch 257, releasable by an actuator, such as a finger tab 258, operably coupled to selectively secure the head harness 200 (e.g., the harness connector housing 248) to the head restraint mechanism 300. The finger tab 258 functions as an emergency release, allowing the head harness 200 to be quickly removed from the head restraint mechanism if necessary.

[0074] In this exemplary embodiment, chin strap portions 204, 206, halo strap portions 212, 214, and head restraint strap portion 242 are constructed from a flexible but substantially inelastic material. Halo stabilizers 224, 226 and rear support portion 238 are constructed from a generally rigid material, such as a rigid polymer or composite material. In some exemplary embodiments, padding can be provided on various patient-contacting surfaces of head harness 200.

[0075] 9-11 are isometric views of an exemplary head restraint mechanism 300 according to at least some embodiments of the present disclosure. Generally, the head restraint mechanism 300 is configured to provide three-dimensional positioning of a patient's head. The head restraint mechanism 300 includes a selectively securable harness connector assembly 302. The exemplary harness connector assembly 302 includes a harness connector body 304 and an opposing harness connector stopper 306 disposed on a harness connector shaft 308. A harness connector knob 310 is disposed on the harness connector shaft 308 and operates to axially draw the harness connector knob 310 and the harness connector stopper 306 together, such as by threaded engagement between the harness connector knob 310 and the harness connector shaft 308. The harness connector body 304 includes an axially oriented toothed surface 312 facing the harness connector stopper 306.

[0076] 7-11 , the harness connector assembly 302 of the head restraint mechanism 300 is configured to releasably engage the harness connector housing 248 of the head harness 200. The harness connector stop 306 is sized and shaped to be received within the cavity 250, with the slot 252 receiving the harness connector shaft 308. The toothed surface 254 of the harness connector housing 248 engages with a corresponding toothed surface 312 of the harness connector body 304. The toothed surfaces 254, 312 are engageable at a plurality of discrete relative angular positions over a range of lateral rotation, as indicated by arrow 34 in FIG. 4 . Generally, the teeth of the toothed surfaces 254, 312 are oriented radially relative to the harness connector shaft 308.

[0077] 9-11 , head restraint mechanism 300 includes an arcuate angled guide 314 that is substantially vertically upright and has a substantially vertically oriented angled guide slot 316 extending therethrough. Harness connector shaft 308 of harness connector assembly 302 extends through angled guide slot 316 between harness connector knob 310 and harness connector body 304. Harness connector knob 310 and harness connector body 304 are wider than angled guide slot 316, thereby retaining harness connector assembly 302 on angled guide 314. Harness connector assembly 302 is slidable substantially vertically upward and downward along the length of angled guide slot 316 to provide a range of motion for neck flexion and extension indicated by arrow 36, as described above with reference to FIGS. 5 and 6 .

[0078] Tightening the harness connector knob 310 with the stop 306 of the harness connector assembly 302 within the cavity 250 of the harness connector housing 248 of the head harness 200 operates to secure the head harness 200 relative to the angled guide 314. More specifically, tightening the harness connector knob 310 secures the connector body 304 relative to the angled guide slot 316 and / or fixes the relative angular position of the toothed surfaces 254, 312. Loosening the harness connector knob 310 operates to allow movement of the harness connector assembly 302 along the angled guide slot 316 and / or to allow relative angular movement between the toothed surfaces 254, 312.

[0079] 1-3 and 9-11 , the exemplary head restraint mechanism 300 includes a pivot arm 318 that operably couples the tilt guide 314 and the support plate assembly 600. The pivot arm 318 includes a rotatable connector element, such as a pivot arm bore 320, where the pivot arm is pivotally connected to the support plate assembly 600. The pivot arm 318 is pivotable about a pivot axis 322 that is substantially perpendicular to the top surface of the support plate assembly 600 (and the top surface of the table 12), providing a range of motion for lateral flexion of the patient's neck 30, as indicated by arrow 32. In this exemplary embodiment, the pivot arm bore 320 is disposed adjacent one end of the pivot arm 318, and the opposite end of the pivot arm 318 includes a swing lock assembly 324 configured to selectively lock the pivot arm 318 in a desired angular position.

[0080] Swivel lock assembly 324 includes a locking element, such as an extendable tooth 326, operably connected to swing adjustment knob 328 for selective engagement between swing arm 318 and a corresponding component of support plate assembly 600. In the exemplary embodiment, swing lock assembly 324 is disposed on a downwardly extending flange 330 adjacent to an edge of support plate assembly 600 such that swing lock assembly 324 engages the edge of support plate assembly 600.

[0081] 9-11 , in this exemplary embodiment, the tilt guide 314 is selectively repositionable on the pivot arm 318. For example, the tilt guide 314 is longitudinally slidable and selectively fixable relative to the longitudinal axis of the pivot arm 318. The tilt guide 314 includes one or more tilt guide adjustment slots 332, 334 that receive threaded fasteners extending therethrough from the pivot arm 318. Respective tilt guide adjustment knobs 336, 338 are operably connected to the threaded fasteners to selectively fix the tilt guide 314 in a desired longitudinal position relative to the pivot arm 318.

[0082] 12 is an isometric view of an exemplary shoulder restraint 400 in a locked configuration, FIG. 13 is an isometric partial cutaway view of shoulder restraint 400 in an unlocked configuration, and FIG. 14 is an isometric view of the shoulder restraint in a locked configuration, all according to at least some aspects of the present disclosure. The following description focuses on shoulder restraint 400. However, the following description also generally applies to the substantially similar shoulder restraint 402.

[0083] 1, 2, and 12-14, shoulder restraints 400, 402 associated with chest elevator 500 are generally configured to facilitate positioning and / or stabilizing a patient's upper torso 24 in conjunction with stabilizing the patient's head 14. The exemplary shoulder restraint 400 includes a generally upright shoulder restraint portion 404 configured to engage a patient's shoulder 20, such as the upper surface of the patient's shoulder 20. Shoulder restraint portion 404 includes a base 406 that is selectively slidably coupled to a shoulder restraint connection element 407 that is attached to a support plate assembly 600, as described below. In this exemplary embodiment, base 406 includes a longitudinal slot 408, and connection element 407 includes a lateral slot 409, both of which slidably receive a latch assembly 410. Connection element 407 includes a support plate retention element, such as surface 424.

[0084] The latch assembly 410 is configured to selectively secure the shoulder restraint 400 to the connecting element 407 and the patient support plate assembly 600. The latch assembly 410 includes a housing 412, a handle 414 pivotally disposed relative to the housing 412, a locking element 416, and a linkage 418 pivotally connected to each of the handle 414 and the locking element 416. The housing 412 and the handle 414 are disposed on the base 406. The linkage 418 and / or the locking element 416 extend downwardly through the housing to below the base 406 and the connecting element 407. The locking element 416 includes a boss 420 and a flange 422. The boss 420 extends downwardly through a lateral slot 409 in the connecting element 407, and the flange 422 extends below the slot 409 and wider than the lateral slot 409.

[0085] The exemplary latch assembly 410 is operated by pivoting the handle 414 relative to the housing 412 between a locked configuration ( FIGS. 12 and 14 ) and an unlocked configuration ( FIG. 13 ). Rotating the handle 414 from the locked configuration to the unlocked configuration (arrow 414 a) causes the linkage 418 to move generally downward, which in turn causes the locking element 416 to move downward (arrow 416 a). This downward movement increases the distance between the flange 422 and the housing 412. In the unlocked configuration, the linkage 418 is slidable within the longitudinal slot 408, and the boss 420 is slidable within the lateral slot 409. Thus, in the unlocked configuration, the shoulder restraint portion 404 is vertically and horizontally repositionable relative to the patient support plate assembly 600 and the table 12.

[0086] Similarly, pivoting the handle 414 (arrow 414b) from the unlocked configuration ( FIG. 13 ) to the locked configuration ( FIG. 14 ) causes the linkage 418 to move generally upward, and the locking element 416 to move upward (arrow 416b). This upward movement reduces the distance between the flange 422 and the housing 412. In the locked configuration, the base 406 and the connecting element 407 are secured (e.g., compressed) between the housing 412 and the flange 422, thereby securing the shoulder restraint portion 404 relative to the patient support assembly 600 and the table 12. The handle 414, linkage 418, and housing 412 can be configured such that the handle 414 is over-center in the locked configuration, which can prevent inadvertent movement of the latch assembly 410 from the locked to the unlocked configuration.

[0087] Some exemplary embodiments may include a padded patient-contacting surface. For example, referring to FIG. 2 , shoulder restraint 402 is shown with shoulder pads 426. Shoulder pads 426 may be permanently or releasably secured to shoulder restraint 402. For example, pads 426 may be attached using surface fasteners, screws, clamps, clips, and / or adhesives. In some exemplary embodiments, pads 426 may be disposable, while in other embodiments, pads 426 may be reusable (e.g., easily cleanable between patients). It should be understood that other patient-contacting surfaces of head stabilization system 100, such as shoulder restraint 400, may also include similar pads.

[0088] FIG. 15 is an isometric view of an exemplary patient support plate assembly 600 according to at least some embodiments of the present disclosure. With reference to FIGS. 1, 2, and 15, the patient support plate assembly 600 is generally configured to secure the head stabilization system 100 to the table 12 and to support various other components of the head stabilization system 100. The exemplary patient support plate assembly 600 comprises a substantially flat and substantially rigid support plate 601 to which the support plate assembly 600 and other components of the head stabilization system 100 are attached. The support plate assembly 600 includes one or more attachment elements, such as support plate fastening slots 602, 604, configured to secure the support plate assembly 600 to a patient support apparatus (e.g., angiography table 12). For example, the support plate fastening slots 602, 604 can engage with support plate attachment elements (e.g., straps 26 and / or clamps 28) that secure the patient support plate assembly 600 to the table 12. Other mounting elements on the support plate assembly 600 may be used in conjunction with other types of support plate mounting elements.

[0089] The exemplary support plate assembly 600 includes a head restraint mechanism connector 606 configured to releasably and pivotally couple the head restraint mechanism 300 to the support plate assembly 600. The head restraint mechanism connector 606 includes a connector base 608 secured to the support plate 601 and a removable connector cap 610. In this exemplary embodiment, the connector cap 610 extends through the pivot arm bore 320 ( FIGS. 9-11 ) of the head restraint mechanism 300 and is configured to releasably couple with the connector base 608. For example, the connector cap 610 may include one or more radially extending tabs 612 that may be configured to engage with corresponding slots 614 in the connector base 608. Approximately a quarter-turn (e.g., clockwise) of the connector cap 610 operates to secure the connector cap 610 to the connector base 608, thereby securing the head restraint mechanism 300 to the support plate assembly 600. Similarly, rotating the connector cap 610 approximately a quarter turn in the opposite direction (e.g., counterclockwise) releases the connector cap 610 from the connector base 608, thereby releasing the head restraint mechanism 300. In an exemplary embodiment, the head restraint mechanism 300 is generally held against the upper surface of the support plate assembly 600 by the connector cap 610, while the head restraint mechanism 300 remains pivotable about the head restraint mechanism connector 606, flexing the patient's neck 30 laterally, as shown in FIG. 3 . One or more of the interfacing surfaces of the head restraint mechanism connector 606 and / or the head restraint mechanism 300 may include a lubricating material (e.g., low-friction polytetrafluoroethylene or polyoxymethylene plastic) or bearing elements, such as rolling element bearings, to facilitate adjustment of the head restraint mechanism 300, for example.

[0090] The exemplary support plate assembly 600 includes a swing lock engaging element 616 configured to operably engage with the swing lock assembly 324 ( FIGS. 9-11 ). In this exemplary embodiment, the swing lock engaging element 616 comprises an edge of the support plate assembly 600 that includes a slot 618 shaped substantially as a radius relative to the head restraint mechanism connector 606. The slot 618 includes a plurality of teeth 620 configured to releasably engage with the extendable teeth 326 of the swing lock assembly 324 ( FIGS. 10 and 11 ) to selectively secure lateral flexion of the patient's head. The swing lock engaging element 616 and / or one or more of the interfacing surfaces of the head restraint mechanism 300 may include a bearing element, such as a lubricious material (e.g., low-friction polytetrafluoroethylene or polyoxymethylene plastic), for example, to facilitate adjustment of the head restraint mechanism 300.

[0091] The exemplary support plate assembly 600 includes shoulder restraint connection elements 622, 624 for attaching shoulder restraints 400, 402 to the support plate 601. The following description focuses on the shoulder restraint connection element 622 associated with shoulder restraint 400. However, the following description also generally applies to the substantially similar shoulder restraint connection element 624 associated with shoulder restraint 402.

[0092] 12-15 , the exemplary shoulder restraint connection element 622 includes a transverse slot 626 configured to slidably receive the connection element 407 of the shoulder restraint 400 therein. The shoulder restraint connection element 622 includes a retaining element, such as an upwardly extending boss 628. The boss 628 is configured to releasably engage with the support plate retaining element (e.g., surface 424) of the shoulder restraint 400 to secure the shoulder restraint 400 to the support plate assembly 600.

[0093] In this exemplary embodiment, shoulder restraint connection element 622 is formed from an elastomeric material and is releasably connectable to support plate 601. For example, shoulder restraint connection element 622 is formed with a peripheral groove 630 that receives a corresponding flange 632 of support plate 601 therein.

[0094] 1, 2, 5, 6, and 15, a chest elevator 500 configured to facilitate vertical positioning of a patient's upper torso 24 is disposed on a support plate 601. The chest elevator 500 may be utilized to elevate the patient's upper torso 24, such as to improve access to the C1-C2 puncture site 48. The exemplary chest elevator 500 includes an inflatable membrane 502 disposed between the support plate 601 and the patient's upper torso 24 (e.g., above the support plate 601 and below the patient's upper torso 24). Inflating the inflatable membrane 502 generally raises the patient's upper torso 24 relative to the support plate 601, and deflating the inflatable membrane 502 generally lowers the patient's upper torso 24 toward the support plate 601. The inflatable membrane 502 is operably coupled to a pressurized air source 504, such as by appropriate tubing, valves, and connectors. In some exemplary embodiments, pressurized air source 504 may comprise a pressurized air supply system installed in a healthcare facility, while in other exemplary embodiments, pressurized air source 504 may comprise a portable air source (e.g., a portable compressor or a portable compressed air tank).

[0095] Various components of exemplary head stabilization system 100 according to at least some aspects of the present disclosure may be constructed from materials that generally do not interfere (or only minimally interfere) with various imaging modalities. For example, all or substantially all of the components comprising exemplary head stabilization system 100 may be constructed from suitable materials that are non-metallic and do not substantially interfere with imaging of the patient's cranial anatomy. For example, various known polymers and / or composite materials may be utilized as components of head stabilization system 100.

[0096] An exemplary method of using an exemplary head stabilization system 100 according to at least some embodiments of the present disclosure is described below and may include optional and / or alternative structures and / or operations. The head stabilization system 100 may be prepared for use. With reference to FIG. 1 , the support plate assembly 600 is attached to a patient support apparatus (e.g., an angiography table 12). For example, one or more support plate attachment elements (e.g., straps 26 and / or clamps 28) are installed to secure the support plate assembly to the table 12. If not already attached, the head restraint mechanism 300, shoulder restraints 400, 402, and chest elevator 500 are attached. With reference to FIG. 2 , one or more pads (e.g., shoulder pad 426) may be attached. With reference to FIG. 15 , the chest elevator 500 is lowered, such as by deflating the inflatable membrane 502.

[0097] FIG. 16 is an isometric view of an exemplary head stabilization system 100 with the head harness 200 disconnected from the head restraint mechanism 300, according to at least some embodiments of the present disclosure. With reference to FIGS. 1 , 7 , 8 , and 16 , the patient's head 14 may be secured to the head harness 200 while the head harness 200 is disconnected from the head restraint mechanism 300. In some circumstances, the head harness 200 may be secured to the patient's head 14 before the patient 10 is positioned on the patient support plate 600 and / or table 12. Alternatively, the patient 10 may be placed on the patient support plate 600 and / or table 12 before the head harness 200 is secured to the patient's head 14. In some circumstances, the patient's head may be secured to the head harness 200 while the head harness 200 is attached to the head restraint mechanism 300.

[0098] 7 and 8, head harness 200 is applied and attached to patient's head 14. Halo portion 210 and rear support portion 238 are positioned to substantially surround patient's head 14. Halo adjustment knob 218 is utilized to facilitate mating and securing of halo portion 210 and rear support portion 238. Head restraint strap portion 242 is attached and secured using head restraint strap adjustment knob 246. Chin strap portion 202 is placed over chin / jaw region 38 of patient's head 14, and chin strap portion 234 of halo stabilizers 224, 226 is connected to halo strap portion 232, if not already attached.

[0099] 1 and 16, a patient is positioned on the patient support plate 600 and table 12. For example, the patient 10 may be positioned in a generally supine position (e.g., lying generally horizontally with the front of the torso and face up). The shoulder restraints 400, 402 may be adjusted laterally and / or vertically as needed to engage the patient's shoulders 20, 22 and / or flex the patient's shoulders 20, 22 generally toward the patient's feet. For example, the latch assemblies 410 of the shoulder restraints 400, 402 may be unlocked and / or locked as needed, leaving them in a locked configuration when adjustments are complete.

[0100] 1 , 7-11 , and 16 , the head restraint mechanism 300 can be repositioned as needed to engage the harness connector housing 248 of the head harness 200 with the harness connector assembly 302 of the head restraint mechanism 300 (if not already connected). For example, the harness connector assembly 302 can be loosened (e.g., by loosening the harness connector knob 310) to allow adjustment of the harness connector assembly 302 along the angle guide slot 316. In some exemplary embodiments, the harness connector knob 310 can remain loose while the harness connector housing 248 is engaged with the harness connector assembly. The angle guide 314 can be loosened relative to the pivot arm 318 (e.g., the angle guide adjustment knobs 336, 338 can be loosened) to allow longitudinal adjustment of the angle guide 314 relative to the pivot arm 318. The locking element of the swing lock assembly 324 can be loosened (eg, by loosening the swing adjustment knob 328 ) to allow the swing arm 318 to swing about the head restraint connector 606 .

[0101] After the harness connector housing 248 of the head harness 200 is coupled to the harness connector assembly 302 of the head restraint mechanism 300, the head stabilization system 100 may be adjusted to position and orient the patient's head 14 as desired. For example, the head stabilization system 100 may be adjusted (e.g., various components may be loosened, repositioned, and / or tightened) to facilitate any of the movements described above with respect to Figures 3-6 and / or to stabilize the patient's head 14 in a desired position and / or orientation.

[0102] 9-11, the angle guide 314 can be longitudinally positioned as needed relative to the pivot arm 318. The angle guide adjustment knobs 336, 338 can be tightened to secure the angle guide 314 relative to the pivot arm 318. With reference to FIGS. 3, 9-11, and 15, the lateral flexion of the patient's neck 30 can be adjusted and the locking element of the swing lock assembly 324 can be tightened (e.g., the swing adjustment knob 328 can be tightened) to secure the swing arm 318 in a desired angular orientation about the head restraint connector 606.

[0103] With reference to FIGS. 4 and 7-11, the harness connector assembly 302 can be loosened (e.g., by loosening the harness connector knob 310) to allow for lateral rotational positioning of the patient's head 14. That is, the head harness 200 can be rotated about the harness connector shaft 308. Once the desired orientation is achieved, the harness connector knob 310 can be tightened to engage the tooth surfaces 254, 312, thereby fixing the lateral rotational position of the patient's head 14. With reference to FIGS. 5, 6, and 9-11, the harness connector assembly 302 can be loosened (e.g., by loosening the harness connector knob 310) to allow for adjustment of the extension or compression of the patient's neck 30. That is, the harness connector assembly 302 can be repositioned along the angled guide slot 316. Once the desired position is achieved, the harness connector knob 310 can be tightened to secure the harness connector assembly 302 relative to the angled guide slot 316. Some exemplary methods may include loosening the harness connector assembly 302, adjusting both the lateral rotational position of the patient's head 14 and the extension or compression of the patient's neck 30, and tightening the harness connector assembly.

[0104] 1 and 15, chest elevator 500 can be operated (e.g., inflatable membrane 502 can be at least partially inflated) to raise the patient's upper torso 24 relative to support plate assembly 600.

[0105] An exemplary method of manufacturing the head stabilization system 100 may include installing the head restraint mechanism 300, such as installing the head restraint mechanism 300 on the patient support plate assembly 600. The method may include installing at least one shoulder restraint 400, 402, such as installing at least one shoulder restraint 400, 402 on the patient support plate assembly 600. The method may also include installing the chest elevator 500, such as installing the chest elevator 500 on the patient support plate assembly 600.

[0106] 17 is an isometric view of an alternative exemplary head restraint mechanism 300a according to at least some aspects of the present disclosure. Generally, head restraint mechanism 300a is similar in structure and operation to head restraint mechanism 300 described above, and other head restraint mechanisms may be substituted for head restraint mechanism 300a, or any features of head restraint mechanism 300a may be used, in various other exemplary embodiments according to the present disclosure. Like reference numerals refer to like components. For the sake of brevity, the following description will omit redundant description and focus on the differences between head restraint mechanism 300a and head restraint mechanism 300.

[0107] The exemplary head restraint mechanism 300a is configured to provide three-dimensional positioning of a patient's head. The head restraint mechanism 300a includes a selectively securable harness connector assembly 302a. The exemplary harness connector assembly 302a includes a harness connector body 304a and an opposing harness connector stopper 306a disposed on the harness connector shaft. A harness connector knob 310a is disposed on the harness connector shaft and operates to draw the harness connector knob 310a and the harness connector stopper 306a axially together, such as by threaded engagement between the harness connector knob 310a and the harness connector shaft.

[0108] The head restraint mechanism 300a includes a generally vertically upright, arcuately shaped angled guide 314a with a generally vertically oriented angled guide slot 316a extending therethrough. The harness connector shaft of the harness connector assembly 302a extends through the angled guide slot 316a between the harness connector knob 310a and the harness connector body 304a. The harness connector assembly 302a is slidable up and down generally vertically along the length of the angled guide slot 316a. Tightening the harness connector knob 310a with the stopper 306a of the harness connector assembly 302a within the cavity 250 of the harness connector housing 248 of the head harness 200 acts to secure the head harness 200 relative to the angled guide 314a.

[0109] In this example head restraint mechanism 300a, the angled guide 314a includes a plurality of laterally extending through-holes 314b. The holes 314b are positioned generally along the length of the angled guide slot 316a at the location where it is desired to secure the harness connector assembly 302a. The holes 314b are configured to laterally receive a locking pin 304b therethrough. The pin includes a head 304c that may have a diameter larger than the diameter of the holes 314b. The harness connector body 304a of the harness connector assembly 302a includes a corresponding laterally extending through-hole that may be configured to receive the pin 304b therethrough. When it is desired to lock the harness connector assembly 302a in a particular position along the angled guide slot 316a, the hole in the harness connector body 304a is aligned with one of the holes 314b in the angled guide 314a. The pin 304b is then inserted into the hole in the harness connector body 304a and the selected hole 314b in the angled guide 314a. With the pin 304b in place, the harness connector assembly 302a is secured in the selected position along the angled guide slot 316a. The pin 304b can be used to secure the harness connector assembly 302a in addition to and / or instead of tightening the harness connector knob 310a as described above.

[0110] 18 is an isometric view of an alternative exemplary head harness 1200 according to at least some aspects of the present disclosure. In general, in various other exemplary embodiments according to the present disclosure, head harness 1200 is similar in structure and operation to head harness 200 described above, and head harness 1200 can be used in place of other head harnesses or can use any features of head harness 1200. Like reference numerals refer to like components. For brevity, the following description will omit redundant description and focus on the differences between head harness 1200 and head harness 200.

[0111] The exemplary head harness 1200 includes a chin strap portion 1202 and a halo portion 1210. The halo portion 1210 is connected to the chin strap portion 1202 by a right halo stabilizer 1224 and a left halo stabilizer 1226. The halo stabilizers 1224, 1226 are substantially similar, and for brevity, only the right halo stabilizer 1224 will be described in detail. The right halo stabilizer 1224 includes two removably connected portions: a halo strap portion 1232 and a chin strap portion 1234. The halo strap portion 1232 and the chin strap portion 1234 are secured together by a releasable catch operated by an actuator, such as a release button 1236. When actuated by a user, the release button 1236 releases the chin strap portion 1234 from the halo strap portion 1232. In some embodiments, button 1236 can function as an emergency release that allows the patient to quickly disconnect from head stabilization system 100. The left halo stabilizer 1226 is constructed in a substantially similar manner and includes a similar button that provides emergency release of the chin strap.

[0112] The exemplary head harness 1200 includes a head restraint portion 1240 that extends from front to back across the center of the patient's head. The head restraint portion 1240 includes a head restraint element 1244. The exemplary head harness 1200 includes a connection element, such as a harness connector housing 1248, configured to releasably couple the head harness 1200 to a head restraint mechanism. The harness connector housing 1248 is disposed on the restraint element 1244 and includes a cavity 1250 and a slot 1252 terminating in a generally circular opening 1255, configured to releasably engage corresponding components of the head restraint mechanism, as described below. The slot 1252 and opening 1255 extend through a wall 1256 that at least partially defines the cavity 1250.

[0113] 19 is an isometric view of an alternative exemplary head restraint mechanism 1300 according to at least some aspects of the present disclosure. In general, in various other exemplary embodiments according to the present disclosure, head restraint mechanism 1300 is similar in structure and operation to head restraint mechanisms 300, 300a described above, and head restraint mechanism 1300 may be replaced by other head restraint mechanisms, or any features of head restraint mechanism 1300 may be used. Like reference numerals refer to like components. For brevity, the following description will omit redundant description and focus on the differences between head restraint mechanism 1300 and head restraint mechanisms 300, 300a.

[0114] The exemplary head restraint mechanism 1300 is configured to provide three-dimensional positioning of a patient's head. The head restraint mechanism 1300 includes a selectively securable harness connector assembly 1302. The exemplary harness connector assembly 1302 includes a harness connector knob 1310 and an opposing harness connector stopper 1306 disposed on a harness connector shaft 1308. The harness connector knob 1310 operates to axially draw the harness connector knob 1310 and the harness connector stopper 1306 together, such as by threaded engagement between the harness connector knob 1310 and the harness connector shaft 1308. The head restraint mechanism 1300 includes a generally vertically upstanding arcuate angled guide 1314 having a generally vertically oriented angled guide slot 1316 therethrough. The harness connector shaft 1308 extends through the angled guide slot 1316 between the harness connector knob 1310 and the harness connector stopper 1306. The harness connector assembly 1302 is slidable up and down approximately vertically along the length of the angled guide slot 1316 .

[0115] In this exemplary embodiment, the harness connector stopper 1306 is in the form of a generally spherical ball configured to be received within the cavity 1250 of the harness connector housing 1248 shown in FIG. 18 . The harness connector shaft 1308 is configured to be received through the slot 1252 and the opening 1255. Tightening the harness connector knob 1310 on the stopper 1306 of the harness connector assembly 1302 within the cavity 1250 of the harness connector housing 1248 of the head harness 1200 operates to secure the head harness 1200 relative to the angled guide 1314. For example, the stopper 1306 can be partially retracted into and / or seated in the opening 1255.

[0116] In some exemplary embodiments, the harness connector knob 1310 may include a release button 1311 that may be configured to facilitate quick removal of the head harness 1200 from the head restraint mechanism 1300 when depressed generally axially along the harness connector shaft 1308.

[0117] FIG. 20 is an isometric view of an alternative exemplary head stabilization system 1400 in use with a patient 10, with the patient 10 positioned in a generally sideways position, in accordance with at least some aspects of the present disclosure. While FIG. 20 shows the patient 10 positioned on its left side, the patient 10 may also be positioned on its left or right side. Generally, in various other exemplary embodiments according to the present disclosure, the head stabilization system 1400 is similar in structure and operation to the head stabilization system 100 described above, and the head stabilization system 1400 may be replaced by other head stabilization systems, or any features of the head stabilization system 1400 may be used. Like reference numbers refer to like components.

[0118] The head stabilization system 1400 is typically positioned on a patient support device, such as the head end of the angiography table 12. The head stabilization system 1400 is configured to facilitate various procedures, such as imaging of the patient's head 14 with one or more imaging devices 16, 18 that can be selectively positioned relative to the table 12. Some exemplary embodiments may be used in connection with procedures that include accessing the cerebrospinal fluid space via, for example, the C1-C2 puncture site 48.

[0119] 21 is an isometric view of an exemplary head stabilization system 1400, according to at least some embodiments of the present disclosure. With reference to FIGS. 20 and 21, the exemplary head stabilization system 1400 is generally configured to facilitate a desired positioning of the patient's head 14 and / or to support and stabilize the patient's head 14 (e.g., to immobilize and hold the patient's head 14), such as during a procedure.

[0120] The exemplary head stabilization system 1400 includes a head harness 1500 configured to engage the patient's head 14 and a head restraint mechanism 1600 to which the head harness 1500 is removably attachable. The head restraint mechanism 1600 is configured to facilitate positioning and stabilization of the patient's head 14 relative to the table 12 using the head harness 1500. The exemplary head stabilization system 1400 includes a torso pad 1450 configured to support and adjust the position of the patient's upper torso 24 and a neck pad 1460 configured to support and / or adjust the position of the patient's neck 30. The torso pad 1450 may be inflatable and / or adjustable to facilitate positioning of the patient 10. The neck pad 1460 may be inflatable and / or adjustable to facilitate positioning of the patient's neck 30. The head restraint mechanism 1600, the torso pad 1450, and the neck pad 1460 are disposed on a support plate assembly 1410. The support plate assembly 1410 is secured to the table 12, such as by one or more support plate attachment elements, such as one or more straps 26 and / or clamps 28. In general, the head stabilization system 1400 enables the patient's head 14 to be positioned and / or oriented in three-dimensional space relative to the imaging devices 16, 18 and the table 12, and stabilizes the patient's head 14 in a desired position.

[0121] 22-25, an overview of possible positioning of the patient's head 14 facilitated by the head stabilization system 1400 is provided to provide context for the following discussion. In general, the exemplary head stabilization system 1400 can be positioned and / or secured in any position and / or orientation within any combination of the ranges of motion described with reference to FIGS. 22-25 to position and / or stabilize the patient's head 14 in a desired position, such as for a procedure.

[0122] 22 is a side elevation view of an exemplary head stabilization system 1400 illustrating vertical positioning of a patient's head 14, according to at least some embodiments of the present disclosure. Generally, this articulation of the head restraint mechanism 1600 positions the patient's head 14 vertically up or down, as indicated by arrow 1476, in a plane generally perpendicular to the upper surface of the support plate assembly 1410. This vertical flexion motion is similar to the movement that occurs when a patient tilts their head to the right or left to contact their ear with the shoulder 20, 22 on the same side without rotating the head 14. This exemplary head stabilization system 1400 facilitates approximately 30° of vertical flexion below center and 30° of vertical flexion above center, for a total range of approximately 60° of lateral flexion from bottom to top.

[0123] 23 is a head elevation view of an exemplary head stabilization system 1400 illustrating rotational positioning of the patient's head 14, according to at least some embodiments of the present disclosure. Generally, this articulation of the head harness 1500 relative to the head restraint mechanism 1600 rotates the patient's head 14 to the patient's right or to the patient's left, as indicated by arrow 1478, in a plane generally perpendicular to the upper surface of the support plate assembly 1410. This movement is generally similar to the movement that occurs when a patient attempts to rotate their head 14 left or right to say "no." This exemplary head stabilization system 1400 facilitates approximately 60° of right rotation and approximately 60° of left rotation, for a total rotation range of approximately 120°.

[0124] 24 and 25 are plan views of an exemplary head stabilization system 1400 illustrating extension and flexion, respectively, of a patient's neck 30, according to at least some embodiments of the present disclosure. Generally, this articulation of the head restraint mechanism 1600 provides posterior (i.e., extension) and anterior (i.e., flexion) extension and flexion of the patient's neck 30, as indicated by arrow 1480, in a plane generally transverse to the upper surface of the support plate assembly 1410. These movements generally resemble those that occur when a patient attempts to nod their head 14 up and down to say "yes." This exemplary head stabilization system 1400 facilitates approximately 25° of posterior neck extension (from neutral) and approximately 25° of anterior neck flexion (from neutral), for a full range of extension and flexion of approximately 50°. The position shown in FIG. 25 can improve access to the cerebrospinal fluid space via the C1-C2 puncture site 48 and facilitate lateral posterior needle introduction. 24 may improve access to the anterior anatomy of the brain. In some cases, it may be advantageous to apply traction to the patient's neck 30. For example, the head restraint mechanism 1600 (via the head harness 1500) may apply a force to the patient's head 14 in a generally upward / cranial direction.

[0125] 26, 26A, and 27 are isometric views of an alternative exemplary head harness 1500 positioned on a patient's head 14, according to at least some aspects of the present disclosure. In general, in various other exemplary embodiments according to the present disclosure, the head harness 1500 is similar in structure and operation to the head harnesses 200, 1200 described above, and the head harness 1500 may be substituted with other head harnesses, or any features of the head harness 1500 may be used. Like reference numbers refer to like components.

[0126] The head harness 1500 is configured to be secured to the patient's head 14 and to be (e.g., releasably) coupled to a head restraint mechanism 1600 ( FIG. 21 ). Generally, the exemplary head harness 1500 is configured to engage the patient's head 14 at the chin / chin region 38, the forehead region 40, and the posterior region 42. In some exemplary embodiments, the head harness 1500 can be configured to securely engage the patient's head in a non-traumatically, non-penetrating manner (e.g., components of the head harness 1500 cannot penetrate the patient's skin).

[0127] The exemplary head harness 1500 includes a chin strap portion 1502 configured to engage the patient's chin / jaw region 38. The chin strap portion 1502 facilitates control of the position of the patient's chin relative to the patient's neck 30. The chin strap portion 1502 includes a right chin strap portion 1504 and a left chin strap portion 1506, which extend forward and downward generally along the patient's mandible and hold a chin pad 1508 against the patient's chin / jaw region 38. The chin strap portions 1504, 1506 may be adjustable, such as by an adjustable buckle-type connector 1534.

[0128] The illustrative head harness 1500 includes one or more chin strap end connectors 1532. The right chin strap portion 1504 is connected to the chin strap end connector 1532 by an adjustable buckle-type connector 1534 with an integrated releasable catch 1568. The chin strap end connector 1532 and the adjustable buckle-type connector 1534 are secured together by a releasable catch 1568 operated by an actuator, such as one or more catch release tabs 1536. When actuated by a user, the catch release tab 1536 releases the adjustable buckle-type connector 1534 from the chin strap end connector 1532. In some embodiments, the catch release tab 1536 can function as an emergency release that allows the patient 10 to be quickly disconnected from the head stabilization system 1400. For example, if the patient's airway is compromised, it may be desirable to quickly access the patient's mouth by removing the chin strap portion 1502 (e.g., by actuating the catch release tab 1536 as an emergency release for the chin strap). In some embodiments, the catch release tab 1536 may be configured for one-handed operation. The left chin strap portion 1506 is constructed in a substantially similar manner to provide for emergency release of the chin strap.

[0129] The exemplary head harness 1500 includes a halo portion 1510 configured to engage the patient's forehead 40 and the side portions 44, 46 of the patient's head 14. The halo portion 1510 includes a right halo strap portion 1512 and a left halo strap portion 1514. The halo strap portions 1512, 1514 extend front to back along the patient's head 14. The halo strap portions 1512, 1514 are coupled at the front to a halo adjustment mechanism 1516 configured to adjust the halo portion 1510 to provide a secure fit to an individual patient's head 14. The halo adjustment mechanism 1516 may include one or more tabs 1572 for alignment clips 1574. The alignment clips 1574 may include radiopaque markings 1576, which may be useful, for example, for calibrating imaging equipment.

[0130] In the exemplary head harness 1500, the halo portion 1510 is connected to the chin strap portion 1502 by a right halo stabilizer 1524 and a left halo stabilizer 1526. Each halo stabilizer 1524, 1526 is generally L-shaped with a generally horizontal top portion attached to the respective halo strap portion 1512, 1514 and a portion closer to the patient's forehead 40 connected to the respective chin strap portion 1504, 1506. In this exemplary embodiment, the halo stabilizers 1524, 1526 are substantially rigid, and each halo strap portion 1512, 1514 is secured through the respective stabilizer 1524, 1526, such as by one or more alignment clips 1528. The alignment clips 1528 may include radiopaque markings 1576, which may be useful, for example, for calibrating the imaging equipment. The chin strap portions 1504, 1506 are pivotally attached to the halo stabilizers 1524, 1526 by ball joint connections 1560 or the like, which allow rotational adjustment to securely fit the individual patient's head 14. Each ball joint connection 1560 includes a generally spherical bearing stud 1562 attached to a chin strap end connector 1532 and a generally spherical socket 1564 integrated into the respective halo stabilizer 1524, 1526. Each chin strap portion 1504, 1506 is connected to an adjustable buckle-type connector 1534 connected to the chin strap end connector 1532, which is connected to the respective stabilizer 1524, 1526.

[0131] The exemplary head harness 1500 includes a rear support portion 1538, which may be in the form of a generally annular ring configured to be centrally positioned on the rear region 42 of the patient's head 14. The rear support portion 1538 is coupled to each of the halo strap portions 1512, 1514 such that the patient's head 14 is substantially circumscribed by the left halo strap portion 1514, the halo adjustment mechanism 1516, the right halo strap portion 1512, and the rear support portion 1538. The rear support portion 1538 and the halo adjustment mechanism 1516 are also connected by a head restraint portion 1540, which extends front to back beyond the center of the top of the patient's head 14.

[0132] In this exemplary embodiment, head restraint portion 1540 includes a front head restraint strap portion 1541, a rear head restraint strap portion 1542, and a head restraint element 1544 disposed thereon. Head restraint portion 1540 may include radiopaque markings 1576, which may be useful, for example, for calibrating imaging equipment. Head restraint portion 1540 may be configured to be adjustable to provide a secure fit to an individual patient's head 14. In this exemplary embodiment, head restraint element 1544 includes a head restraint strap adjustment knob assembly 1546 configured to adjust head restraint strap portions 1541, 1542 to provide a secure fit to the patient's head 14. Front head restraint strap portion 1541 includes a longitudinal slot 1580 such that a row of teeth 1582 is aligned along one side of slot 1580. The rear head restraint strap portion 1542 includes a longitudinal slot 1584 such that a row of teeth 1586 is aligned along one side of the slot 1584 such that the teeth 1586 are aligned opposite the teeth 1582 of the front strap portion 1541 when the strap portions 1541, 1542 are in their deployed positions. The adjustment knob assembly 1546 includes a radially oriented gear 1588 that engages with the teeth 1582, 1586 of the strap portions 1541, 1542 such that, as the adjustment knob assembly 1546 is rotated, the strap portions 1541, 1542 move relative to one another to lengthen or shorten the length of the head restraint portion 1540 and provide a tighter fit around the patient's head 14.

[0133] The exemplary head harness 1500 includes a connection element, such as a harness connector housing 1548, configured to releasably couple the head harness 1500 to the head restraint mechanism 1600. In this exemplary embodiment, the harness connector housing 1548 is provided on the head restraint element 1544 and includes a cavity 1550 and a slot 1552 configured to releasably engage corresponding components of the head restraint mechanism 1600, as described below. The slot 1552 extends through a wall 1556 that at least partially defines the cavity 1550. Additionally, the harness connector housing 1548 includes a latch 1557 releasable by an actuator, such as one or more finger tabs 1558, operably coupled to selectively secure the head harness 1500 (e.g., the harness connector housing 1548) to the head restraint mechanism 1600. The finger tabs 1558 function as an emergency release, allowing the head harness 1500 to be quickly removed from the head restraint mechanism 1600 if necessary. In some embodiments, the finger tab 1558 may be configured for one-handed operation.

[0134] In this exemplary embodiment, chin strap portions 1504, 1506, halo strap portions 1512, 1514, and head restraint strap portions 1541, 1542 are constructed from a flexible but substantially inelastic material. Halo stabilizers 1524, 1526 and rear support portion 1538 are constructed from a generally rigid material, such as a rigid polymer or composite material. In some exemplary embodiments, padding can be provided on various patient-contacting surfaces of head harness 1500.

[0135] 28-30 are isometric views of an alternative exemplary head restraint mechanism 1600 according to at least some aspects of the present disclosure. In general, head restraint mechanism 1600 is similar in structure and operation to head restraint mechanisms 300, 300a, and 1300 described above, and other head restraint mechanisms may be substituted for head restraint mechanism 1600, or any features of head restraint mechanism 1600 may be used, in various other exemplary embodiments according to the present disclosure. Like reference numbers refer to like components.

[0136] Generally, the head restraint mechanism 1600 is configured to provide three-dimensional positioning of the patient's head. In this exemplary embodiment, the head restraint mechanism 1600 includes an angled guide 1602 connected to a vertical support 1612 by a connector assembly 1620. The angled guide 1602 is vertically adjustable on the vertical support 1612 in the direction indicated by arrow 1476, and the angled guide 1602 can be secured to the vertical support 1612 in a plurality of positions. The exemplary connector assembly 1620 includes a connector knob retainer 1622 and an opposing connector stopper 1624 disposed on a connector shaft 1626. A connector knob 1630 and a compression spring 1628 are disposed on the connector shaft 1626 and operate to axially draw the connector knob 1630, compression spring 1628, connector knob retainer 1622, and connector stopper 1624 together, such as by threaded engagement between the connector knob 1630 and the connector shaft 1626. The connector knob 1630 includes an axially facing toothed surface (not shown) that faces an axially facing toothed surface 1623 on the connector knob retainer 1622. The toothed surfaces of the connector knob 1630 and the connector knob retainer 1622 may function to secure the position of the connector knob 1630 relative to the connector knob retainer 1622 when the connector assembly 1620 is drawn together. The angled guide 1602 includes an axially facing toothed surface 1610 that faces an axially facing toothed surface 1625 on the connector stopper 1624. The vertical support 1612 includes a through hole 1614 for the connector shaft 1626. The angled guide 1602 includes a through slot 1608 for the connector shaft 1626. The angled guide 1602 can be positioned vertically in multiple positions on the vertical support 1612 using the engagement of the toothed surfaces 1610, 1625.

[0137] 20-23 and 28-30, an exemplary head restraint mechanism 1600 includes a head restraint mechanism connector assembly 1660 that operably couples the head restraint mechanism 1600 to the support plate assembly 1400. In this exemplary embodiment, the head restraint mechanism connector assembly 1660 allows the head restraint mechanism 1600 to be horizontally adjusted in a plane generally transverse to the top surface of the support plate assembly 1400 (and the top surface of the table 12) in the direction indicated by arrow 1482, and selectively locked in a desired position. In this exemplary embodiment, the head restraint mechanism connector assembly 1660 includes a head restraint connector base 1662, a vertical support mounting plate 1664, and one or more locking devices 1668. The head restraint connector base 1662 is installed and coupled to the support plate assembly 1400. The vertical support mounting plate 1664 is adjustable in the direction of arrow 1482 relative to the head restraint connector base 1662. The locking device 1668 operates to draw the vertical support mounting plate 1664 and the head restraint connector base 1662 together. The head restraint mechanism connector assembly 1660 may include an incremental adjustment mechanism that allows the head restraint mechanism 1600 to be positioned in multiple positions relative to the support plate assembly 1410. In this exemplary embodiment, the head restraint connector base 1662 includes a plurality of parallel toothed surfaces 1670, and the vertical support mounting plate 1664 includes a plurality of matching, opposing parallel toothed surfaces 1672. When the vertical support mounting plate 1664 is in a desired position on the head restraint connector base 1662 and the locking device 1668 is operated, the toothed surfaces 1670, 1672 engage to secure the head restraint mechanism 1600 and prevent movement in the direction indicated by arrow 1482. By adjusting the vertical support mounting plate 1664, and thereby adjusting the head restraint mechanism 1600 in the direction of arrow 1482, a force can be applied to the patient's head 14 in a generally upward / cranial direction. Thus, the patient's neck 30 can be placed in tension in a generally vertical direction.

[0138] In this exemplary embodiment, the head restraint mechanism 1600 includes a selectively securable harness connector assembly 1632. The exemplary harness connector assembly 1632 includes a harness connector stopper 1646, a harness connector body 1636, a connector knob retainer 1634, a harness connector spring 1642, a harness connector knob 1640, and a harness connector nut 1652 disposed on a harness connector shaft 1638. The harness connector knob 1640 operates on the harness connector shaft 1638, such as by threaded engagement between the harness connector nut 1652 and the harness connector shaft 1638, to axially draw the harness connector stopper 1646, the harness connector body 1636, the connector knob retainer 1634, the harness connector spring 1642, the harness connector knob 1640, and the harness connector nut 1652 together. The harness connector knob 1640 includes a radially oriented toothed surface 1641 that faces a radially oriented toothed surface 1635 on the connector knob retainer 1634. The toothed surfaces 1635, 1641 can help secure the position of the connector knob 1640 relative to the connector knob retainer 1634 when the connector assembly 1632 is drawn together. The harness connector stopper 1646 is rotatable about the harness connector shaft 1638, providing a range of rotational motion indicated by arrow 1478 and described above with reference to FIG. 23 . The harness connector stopper 1646 includes a generally hemispherical, radially oriented toothed surface 1648 oriented to engage a generally hemispherical cavity on the harness connector body 1636 and radially opposite a toothed surface 1650. Tightening the harness connector knob 1640 fixes the harness connector stopper 1646 relative to the harness connector body 1636 and / or fixes the relative angular position of the toothed surfaces 1648, 1650. Loosening the harness connector knob 1640 operates to allow movement of the harness connector stopper 1646 relative to the harness connector body 1636 and to allow relative angular movement between the toothed surfaces 1648, 1650.

[0139] 24-30 , the harness connector assembly 1632 of the head restraint mechanism 1600 is configured to releasably engage the angled guide 1602 of the head restraint mechanism 1600. The angled guide includes a cavity 1607, an angled guide slot 1604, and an axially oriented toothed surface 1606 along the length of the angled guide slot 1604. The connector knob retainer 1634 is sized and shaped to be received within the cavity 1607 with the angled guide slot 1604 receiving the harness connector shaft 1638. The connector knob retainer 1634 includes an axially oriented toothed surface 1644 that faces the axially oriented toothed surface 1606 on the angled guide 1602. The axially oriented toothed surface 1644 of the connector knob retainer 1634 can engage with a corresponding toothed surface 1606 of the angled guide 1602 at multiple positions along the angled guide 1602. The toothed surfaces 1644, 1606 are engageable at a number of distinct relative angular positions throughout the range of extension and flexion, as indicated by arrows 1480 in FIGS.

[0140] In this exemplary embodiment, the harness connector stop 1646 of the harness connector assembly 1632 has multiple sides of equal length to allow the harness connector body to engage at multiple positions within the cavity 1550 of the harness connector housing 1548. With the harness connector stop 1646 of the harness connector assembly 1632 within the cavity 1550 of the harness connector housing 1548, tightening the harness connector knob 1640 operates to secure the head harness 1500 relative to the angled guide 1602. More specifically, tightening the harness connector knob 1640 secures the connector knob retainer 1634 relative to the angled guide slot 1604 and / or fixes the relative angular position of the toothed surfaces 1644, 1606. Loosening the harness connector knob 1640 operates to allow movement of the harness connector assembly 1632 along the angled guide slot 1604 and / or to allow relative angular movement between the toothed surfaces 1644, 1606.

[0141] 31A, 31B, 32A, 32B, and 33 are isometric views of an alternative exemplary shoulder restraint 1700 according to at least some aspects of the present disclosure. Generally, in various other exemplary embodiments according to the present disclosure, shoulder restraint 1700 is similar in structure and operation to shoulder restraints 400, 402 described above, and shoulder restraint 1700 may be substituted for other shoulder restraints or may use any features of shoulder restraint 1700. Like reference numbers refer to like components.

[0142] Generally, the shoulder restraint 1700 is configured to position and secure a patient's shoulder. The exemplary shoulder restraint 1700 includes a shoulder restraint bracket 1710, a generally rectangular pad assembly 1720, a locking device 1770, and a shoulder restraint base 1780. The exemplary shoulder restraint bracket 1710 includes a hole 1712 for mounting the pad assembly 1720 and a plurality of dimples 1714 generally arranged in radially opposed pairs around the hole 1712. The exemplary pad assembly 1720 includes a pad 1730 and a mounting plate 1740. The exemplary mounting plate includes a plurality of integral mounting tabs 1742, pad grooves 1744, locking tabs 1746, locating pins 1748, and cavities 1750. The mounting tabs 1742 operate to secure the pad assembly 1720 to the shoulder restraint bracket 1710. Locating pins 1748 on the pad mounting plate 1740 engage with corresponding pairs of dimples 1714 on the shoulder restraint bracket 1710. The dimples 1714 and pins 1748 are engageable at a plurality of discrete relative angular positions. Engagement of the dimples 1714 with the pins 1748 fixes the angular position of the pad assembly 1720 on the shoulder restraint bracket 1710. The pad grooves 1744 are positioned opposite each other within the cavity 1750 to allow the pad 1730 to move within the cavity 1750 in the direction indicated by arrow 1760. A locking tab 1746 fixes the position of the pad 1730 on the pad mounting plate 1740.

[0143] The locking device 1770 attaches the shoulder restraint bracket 1710 to the shoulder restraint base 1780. The shoulder restraint base 1780 attaches the shoulder restraint 1700 to, for example, the support plate assembly 600. Rotating the locking device 1770, for example, clockwise, secures the shoulder restraint bracket 1710 to the shoulder restraint base 1780. Rotating the locking device 1770, for example, counterclockwise, allows the shoulder restraint bracket 1710 to rotate relative to the shoulder restraint base 1780. Rotating the shoulder restraint bracket 1710 relative to the shoulder restraint base 1780 allows the shoulder restraint 1700 to be adjusted, for example, to secure the patient's shoulder.

[0144] 34 and 35 are isometric views of an alternative exemplary shoulder restraint 1800 according to at least some aspects of the present disclosure. Generally, shoulder restraint 1800 is similar to shoulder restraint 1700, substituting a generally rectangular pad assembly 1720 for a generally circular pad assembly 1810. In various other exemplary embodiments according to the present disclosure, shoulder restraint 1800 is generally similar in structure and operation to shoulder restraints 400, 402, and 1700 described above, and shoulder restraint 1800 may be substituted for other shoulder restraints or may use any features of shoulder restraint 1800. Like reference numerals refer to like components. The exemplary shoulder restraint 1800 includes a bracket 1710, a pad assembly 1810, a locking device 1770, and a shoulder restraint base 1780. The exemplary pad assembly 1810 includes a pad 1812 and a plurality of integral mounting tabs 1814. The mounting tabs 1814 operate to secure the pad assembly 1810 to the bracket 1710 .

[0145] 36 is an isometric view of an alternative exemplary head stabilization system 2000 in use on a patient 10, according to at least some aspects of the present disclosure. In various other exemplary embodiments according to the present disclosure, the head stabilization system 2000 is generally similar in structure and operation to the head stabilization systems 100, 1400 described above, and the head stabilization system 2000 may be replaced by other head stabilization systems, or any features of the head stabilization system 2000 may be used. Like reference numbers refer to like components.

[0146] The head stabilization system 2000 is typically positioned on a patient support device, such as the head end of an angiography table 12. The head stabilization system 2000 is configured to facilitate various procedures, such as imaging of the patient's head 14 with one or more imaging devices 16, 18 that can be selectively positioned relative to the table 12. Some exemplary embodiments may be used in connection with procedures that include accessing the cerebrospinal fluid space via, for example, a C1-C2 puncture site 48.

[0147] FIG. 37 is an isometric view of an exemplary head stabilization system 2000 according to at least some embodiments of the present disclosure. With reference to FIGS. 36 and 37 , the exemplary head stabilization system 2000 is generally configured to facilitate desired positioning of the patient's head 14, such as during a procedure, and / or to support and stabilize the patient's head 14 (e.g., to immobilize and hold the patient's head 14). The exemplary head stabilization system 2000 includes a head harness 2200 configured to engage the patient's head 14 and a head restraint mechanism 2300 to which the head harness 2200 is removably attachable. The head restraint mechanism 2300 is configured to facilitate positioning and stabilization of the patient's head 14 relative to the table 12 using the head harness 2200. The exemplary head stabilization system 2000 includes a torso pad 2550 configured to adjust the vertical position of the patient's upper torso 24 and a neck pad 2560 configured to support and / or adjust the position of the patient's neck 30. The torso pad 2550 may be inflatable and / or adjustable to facilitate positioning of the patient 10. The neck pad 2560 may be inflatable and / or adjustable to facilitate positioning of the patient's neck 30. The head restraint mechanism 2000, torso pad 2550, and neck pad 2560 are disposed on a support plate assembly 2600. The support plate assembly 2600 is secured to the table 12 by one or more support plate attachment elements, such as one or more straps 26 and / or clamps 28. In general, the head stabilization system 2000 enables the patient's head 14 to be positioned and / or oriented in three-dimensional space relative to the imaging devices 16, 18 and the table 12, stabilizing the patient's head 14 in a desired position.

[0148] 38-41 , an overview of possible positioning of the patient's head 14 facilitated by the head stabilization system 2000 is provided to provide context for the following discussion. In general, the exemplary head stabilization system 2000 can be positioned and / or secured in any position and / or orientation within any combination of the ranges of motion described with reference to FIGS. 38-41 to position and / or stabilize the patient's head 14 in a desired position, such as for a procedure.

[0149] 38 is a plan view of an exemplary head stabilization system 2000 illustrating lateral positioning of a patient's head 14, according to at least some embodiments of the present disclosure. Generally, this articulation of the head restraint mechanism 2300 provides lateral flexion of the patient's neck 30 to the left or right, as indicated by arrow 2032, in a plane generally parallel to the top surface of the support plate assembly 2600. This lateral flexion motion is similar to the movement that occurs when a patient tilts their head to the right or left to place their ear against the shoulder 20, 22 on the same side without rotating the head 14. This exemplary head stabilization system 2000 facilitates lateral flexion of approximately 30° left of center and approximately 30° right of center, for a total range of lateral flexion of approximately 60° from extreme left to extreme right.

[0150] FIG. 39 is a head elevation view of an exemplary head stabilization system 2000 illustrating rotational positioning of a patient's head 14, according to at least some embodiments of the present disclosure. Generally, this articulation of the head harness 2200 relative to the head restraint mechanism 2300 provides lateral rotation of the patient's head 14 to the left or right, as indicated by arrow 2034, in a plane generally transverse to the upper surface of the support plate assembly 2600. As used herein, "transverse" may refer to a relative angular orientation that is not parallel (e.g., perpendicular or diagonal). This movement generally resembles the movement that occurs when a patient attempts to shake their head 14 from side to side to say "no." This exemplary head stabilization system 2000 facilitates lateral rotation of approximately 60° to the left and approximately 60° to the right, for a total range of lateral rotation of approximately 120°.

[0151] 40 and 41 are side elevation views of an exemplary head stabilization system 2000 illustrating extension and compression, respectively, of a patient's neck 30, according to at least some embodiments of the present disclosure. Generally, this articulation of the head restraint mechanism 2300 provides posterior (i.e., extension) and anterior (i.e., flexion) extension and flexion of the patient's neck 30, as indicated by arrows 2036, in a plane generally perpendicular to the upper surface of the support plate assembly 2600. These movements generally resemble those that occur when a patient attempts to nod their head 14 up and down to say "yes." This exemplary head stabilization system 2000 facilitates approximately 25° of upward neck extension (from neutral) and approximately 25° of downward neck flexion (from neutral), for a full range of extension and flexion of approximately 50°. The position shown in FIG. 40 can improve access to the cerebrospinal fluid space via the C1-C2 puncture site 48 and facilitate lateral posterior needle introduction. 41 may improve access to the anterior anatomy of the brain. In some cases, it may be advantageous to retract the patient's neck 30. For example, the head restraint mechanism 2300 (via the head harness 2200) may apply a force to the patient's head 14 in a generally upward / cranial direction. Thus, the patient's neck 30 may be placed in tension in a generally longitudinal direction.

[0152] 42 and 43 are isometric views of an exemplary head harness 2200 positioned on a patient's head 14, according to at least some aspects of the present disclosure. In various other exemplary embodiments according to the present disclosure, head harness 2200 is generally similar in structure and operation to head harnesses 200, 1200, and 1500 described above, and head harness 2200 may be substituted for other head harnesses or may use any features of head harness 2200. Like reference numbers refer to like components.

[0153] The head harness 2200 is configured to be secured to the patient's head 14 and to be (e.g., releasably) coupled to a head restraint mechanism 2300 ( FIGS. 36 , 37 ). Generally, the exemplary head harness 2200 is configured to engage the patient's head 14 at the chin / chin region 38, the forehead region 40, and the posterior region 42. In some exemplary embodiments, the head harness 2200 can be configured to securely engage the patient's head in a non-traumatically, non-penetrating manner (e.g., components of the head harness 2200 cannot penetrate the patient's skin).

[0154] The exemplary head harness 2200 includes a chin strap portion 2202 configured to engage the patient's chin / jaw region 38. The chin strap portion 2202 facilitates control of the position of the patient's chin relative to the patient's neck 30. The chin strap portion 2202 includes a right chin strap portion 2204 and a left chin strap portion 2206, which extend forward and downward generally along the patient's mandible and hold a chin pad 2208 against the patient's chin / jaw region 38. The chin strap portions 2204, 2206 may be adjustable, such as by a buckle-type connector 2234. The chin strap portions 2204, 2206 may include one or more strap retainers 2266 to secure loose ends of the chin strap portions 2204, 2206.

[0155] The exemplary head harness 2200 includes one or more chin strap end connectors 2232. The right chin strap portion 2204 is connected to the chin strap end connector 2232 by a buckle-style connector 2234 having an integrated, removable catch (not shown). The chin strap end connector 2232 and the buckle-style connector 2234 are secured together by a releasable catch and operated by an actuator, such as a release button 2236. When actuated by a user, the release button 2236 releases the buckle-style connector 2234 from the chin strap end connector 2232. In some embodiments, the release button 2236 can function as an emergency release, allowing the patient 10 to be quickly disconnected from the head stabilization system 2000. For example, if the patient's airway is compromised, it may be desirable to quickly access the patient's mouth by removing the chin strap portion 2202 (e.g., by activating the release button 2236 as an emergency release of the chin strap). In some embodiments, the release button 2236 can be configured for one-handed operation. The left chin strap portion 2206 is constructed in a substantially similar manner to provide an emergency release for the chin strap.

[0156] The exemplary head harness 2200 includes a halo portion 2210 configured to engage the patient's forehead 40 and the side portions 44, 46 of the patient's head 14. The halo portion 2210 includes a right halo strap portion 2212 and a left halo strap portion 2214. The halo strap portions 2212, 2214 extend front to back along the patient's head 14. The halo strap portions 2212, 2214 may be adjustable, such as by an adjustable buckle-type connector 2220, for adjusting the halo strap portions 2212, 2214 to provide a secure fit to an individual patient's head 14. The halo strap portions 2212, 2214 may include one or more strap retainers 2266 to secure loose ends of the halo strap portions 2212, 2214. At the front of the patient's head 14, the halo strap portions 2212, 2214 are coupled to a halo connector housing 2216 by a buckle-style connector 2220 having a releasable catch (not shown) operated by an actuator, such as a release button 2218. When actuated by a user, the release button 2218 releases the buckle-style connector 2220 from the halo connector housing 2216. In some embodiments, the release button 2218 may function as an emergency release allowing the patient 10 to be quickly disconnected from the head stabilization system 2000. In some embodiments, the release button 2218 may be configured for one-handed operation. The halo connector housing 2216 may include one or more tabs 2272 for an alignment clip 2274. The alignment clip 2274 may include radiopaque markings 2276 that may be useful, for example, for calibrating imaging equipment.

[0157] In the exemplary head harness 2200, halo portion 2210 is connected to chin strap portion 2202 by right halo stabilizer 2224 and left halo stabilizer 2226. Each halo stabilizer 2224, 2226 is generally L-shaped with a generally horizontal top portion attached to the respective halo strap portion 2212, 2214 and a portion closer to the patient's forehead 40 connected to the respective chin strap portion 2204, 2206. In this exemplary embodiment, halo stabilizers 2224, 2226 are substantially rigid, and each halo strap portion 2212, 2214 is secured through the respective stabilizer 2224, 2226, such as by one or more alignment clips 2228. Alignment clips 2228 may include radiopaque markings 2276, which may be useful, for example, for calibrating imaging equipment. The chin strap portions 2204, 2206 are pivotally attached to the halo stabilizers 2224, 2226 by ball joint connections 2260 or the like, which allow rotational adjustment to securely fit the individual patient's head 14. Each ball joint connection 2260 includes a generally spherical bearing stud 2262 attached to a chin strap end connector 2232 and a generally spherical socket 2264 integrated into the respective halo stabilizer 2224, 2226. Each chin strap portion 2204, 2206 is connected to an adjustable buckle-type connector 2234 connected to the chin strap end connector 2232, which is connected to the respective stabilizer 2224, 2226.

[0158] The exemplary head harness 2200 includes a rear support portion 2238, which may be in the form of a generally annular ring configured to be centrally positioned about the rear region 42 of the patient's head 14. The rear support portion 2238 is coupled to each of the halo strap portions 2212, 2214 such that the patient's head 14 is substantially circumscribed by the left halo strap portion 2214, the halo connector housing 2216, the right halo strap portion 2212, and the rear support portion 2238. The rear support portion 2238 and the halo connector housing 2216 are also connected by a head restraint portion 2240, which extends front to back across the center of the top of the patient's head 14.

[0159] In this exemplary embodiment, head restraint portion 2240 includes a front head restraint strap portion 2241, a rear head restraint strap portion 2242, and a head restraint element 2244 disposed thereon. Head restraint portion 2240 may include radiopaque markings 2276, which may be useful, for example, for calibrating imaging equipment. Head restraint portion 2240 may be configured to be adjustable to provide a secure fit to an individual patient's head 14. In this exemplary embodiment, head restraint element 2244 includes a head restraint strap adjustment knob assembly 2246 configured to adjust head restraint strap portions 2241, 2242 to provide a secure fit to the patient's head 14. Front head restraint strap portion 2241 includes a cavity 2280 such that a plurality of teeth (not shown) are aligned along one side of cavity 2280. The rear head restraint strap portion 2242 includes a cavity 2284 with a plurality of teeth (not shown) aligned along one side of the cavity 2284 when the strap portions 2241, 2242 are in their installed positions, with the teeth of the rear strap portion 2242 aligned opposite the teeth of the front strap portion 2241. The adjustment knob assembly 2246 includes radially oriented gears (not shown) that engage with the teeth of the strap portions 2241, 2242 as the adjustment knob assembly 2246 is rotated, causing the strap portions 2241, 2242 to move relative to one another and lengthen or shorten the length of the head restraint portion 2240 to provide a secure fit around the patient's head 14.

[0160] The exemplary head harness 2200 includes a connection element, such as a harness connector housing 2248, configured to releasably couple the head harness 2200 to the head restraint mechanism 2300. In this exemplary embodiment, the harness connector housing 2248 is provided on the head restraint element 2244 and includes a cavity 2250 and a slot 2252 configured to releasably engage corresponding components of the head restraint mechanism 2300, as described below. The slot 2252 extends through a wall 2256 that at least partially defines the cavity 2250. Additionally, the harness connector housing 2248 includes a latch 2257 releasable by an actuator, such as one or more finger tabs 2258, operably coupled to selectively secure the head harness 2200 (e.g., the harness connector housing 2248) to the head restraint mechanism 2300. The finger tab 2258 functions as an emergency release, allowing the head harness 2200 to be quickly removed from the head restraint mechanism 2300 if necessary. In some embodiments, the finger tab 2258 may be configured for one-handed operation.

[0161] In this exemplary embodiment, chin strap portions 2204, 2206, halo strap portions 2212, 2214, and head restraint strap portions 2241, 2242 are constructed from a flexible but substantially inelastic material. Halo stabilizers 2224, 2226 and rear support portion 2238 are constructed from a generally rigid material, such as a rigid polymer or composite material. In some exemplary embodiments, padding may be provided on various patient-contacting surfaces of head harness 2200.

[0162] 44-46 are isometric views of an exemplary head restraint mechanism 2300 according to at least some aspects of the present disclosure. In general, head restraint mechanism 2300 is similar in structure and operation to head restraint mechanisms 300, 300a, 1300, and 1600 described above, and other head restraint mechanisms may be substituted for head restraint mechanism 2300, or any features of head restraint mechanism 2300 may be used, in various other exemplary embodiments according to the present disclosure. Like reference numbers refer to like components.

[0163] Generally, the head restraint mechanism 2300 is configured to provide three-dimensional positioning of the patient's head. The head restraint mechanism 2300 includes a selectively securable harness connector assembly 2302. The exemplary harness connector assembly 2302 includes a harness connector stopper 2306, a harness connector body 2304, a harness connector knob retainer 2310, a harness connector knob 2308, and a harness connector nut 2312 disposed on a harness connector shaft 2314. The harness connector knob 2308 operates on the harness connector shaft 2314 to axially draw the harness connector stopper 2306, harness connector body 2304, harness connector knob retainer 2310, harness connector knob 2308, and connector nut 2312 together, such as by threaded engagement between the harness connector nut 2312 and the harness connector shaft 2314. The harness connector stopper 2306 is rotatable about the harness connector shaft 2314, providing a range of rotational motion as indicated by arrow 2034 and described above with reference to FIG.

[0164] In this exemplary embodiment, the harness connector stopper 2306 includes a generally hemispherical, axially oriented toothed surface 2316 facing the harness connector body 2304. The harness connector body 2304 includes a generally hemispherical cavity and an axially oriented toothed surface 2318 oriented to oppose and engage the toothed surface 2316 of the harness connector stopper 2306. Tightening the harness connector knob 2308 with the harness connector stopper 2306 of the harness connector assembly 2302 within the cavity 2250 of the harness connector housing 2248 of the head harness 2200 operates to selectively secure the head harness 2200 relative to the angled guide 2320. More specifically, tightening the harness connector knob 2308 secures the harness connector stopper 2306 relative to the harness connector body 2304 and / or fixes the relative angular position of the toothed surfaces 2316, 2318. Loosening the harness connector knob 2308 operates to allow rotation of the harness connector stopper 2306 about the harness connector shaft 2314 and / or relative angular movement between the toothed surfaces 2316, 2318.

[0165] 44-46, the head restraint mechanism 2300 includes an arcuate angled guide 2320 that is substantially vertically upright and has a substantially vertical angled guide slot 2322 therethrough. The harness connector shaft 2314 of the harness connector assembly 2302 extends through the angled guide slot 2322 between the harness connector knob 2308 and the harness connector stopper 2306. The connector knob retainer 2310 and harness connector body 2304 are wider than the angled guide slot 2322 such that the harness connector assembly 2302 is retained on the angled guide 2320. The harness connector assembly 2302 is slidable substantially vertically upward and downward along the length of the angled guide slot 2322, as indicated by arrow 236, to provide a range of neck flexion and extension motion as described above with reference to FIGS.

[0166] In this exemplary embodiment, the angled guide 2320 includes one or more axially oriented toothed surfaces 2324 on one or both sides of the angled guide slot 2322. In this exemplary embodiment, the connector knob retainer 2310 includes one or more axially oriented toothed surfaces for opposing engagement with the toothed surfaces 2324 of the angled guide 2320. With the harness connector knob retainer 2310 of the harness connector assembly 2302 positioned relative to the angled guide 2320, tightening the harness connector knob 2308 operates to selectively secure the harness connector assembly 2302 relative to the angled guide 2320. More specifically, tightening the harness connector knob 2308 secures the knob retainer 2310 relative to the angled guide 2320 and / or fixes the relative angular positions of the toothed surfaces of the harness connector knob retainer 2310 and the angled guide 2320. Loosening the harness connector knob 2308 allows movement of the harness connector assembly 2302 along the angled guide slots 2322 .

[0167] 42-43 and 44-46, the harness connector assembly 2302 of the head restraint mechanism 2300 is configured to releasably engage the harness connector housing 2248 of the head harness 2200. The harness connector stopper 2306 is sized and shaped to be received within the cavity 2250, with the slot 2252 receiving the harness connector shaft 2314. In this exemplary embodiment, the harness connector stopper 2306 of the harness connector assembly 2302 has multiple sides of equal length such that the harness connector stopper 2306 can engage within the cavity 2250 of the harness connector housing 2248 in multiple positions. With the harness connector stopper 2306 of the harness connector assembly 2302 within the cavity 2250 of the harness connector housing 2248, tightening the harness connector knob 2308 operates to selectively secure the head harness 2200 relative to the angled guide 2320. More specifically, tightening the harness connector knob 2308 secures the harness connector stopper 2306 against the angled guide 2320. Loosening the harness connector knob 2308 allows movement of the harness connector assembly 2302 along the angled guide slot 2322.

[0168] 36, 37, and 44-46, head restraint mechanism 2300 includes a head restraint housing 2330 and one or more tilt guide housings 2350, 2352. In this illustrative embodiment, tilt guide housings 2350, 2352 are coupled to head restraint housing 2330. Tilt guide 2320 is operably coupled to tilt guide housings 2350, 2352. Tilt guide housings 2350, 2352 include push button slots 2354 for push button 2358 and push button springs 2360. Tilt guide 2320 includes a plurality of semi-cylindrical cavities 2338 facing the push button 2358. Push button 2358 includes a cavity facing the semi-cylindrical cavities 2338 on tilt guide 2320. The cavity 2338 and push button 2358 on the tilt guide 2320 are positioned to contain a recessed pin 2364. The tilt guide 2320 is incrementally vertically adjustable relative to the head restraint housing 2330 and tilt guide housings 2350, 2352 in the direction generally indicated by arrow 2338 by selectively disposing the recessed pin 2364 in the cavity 2338. The head restraint housing 2330 includes one or more head restraint housing adjustment slots 2332, 2334 for securing the head restraint mechanism 2300 to the support plate assembly 2600. Respective head restraint housing push levers 2336 are operably connected to the head restraint mechanism housing 2330 and selectively secure the head restraint mechanism housing 2330 in a desired vertical position relative to the support plate assembly 2600.

[0169] 47 and 48 are isometric views of an exemplary patient support plate assembly 2600 according to at least some aspects of the present disclosure. In general, the support plate assembly 2600 is similar in structure and operation to the support plate assemblies 600, 1410 described above in various other exemplary embodiments according to the present disclosure, and like reference numbers refer to like components. The patient support plate assembly 2600 may be substituted with other head restraint mechanisms or may use any of the features of the patient support plate assembly 2600. Like reference numbers refer to like components.

[0170] 36, 37, 47, and 48, the patient support plate assembly 2600 is generally configured to secure the head stabilization system 2000 to the table 12 and to support various other components of the head stabilization system 2000. The exemplary patient support plate assembly 2600 includes a substantially flat, substantially rigid support plate 2601 to which the support plate assembly 2600 and other components of the head stabilization system 2000 are attached. The support plate assembly 2600 includes one or more attachment elements, such as support plate fastening slots 2602, 2604, configured to secure the support plate assembly 2600 to a patient support apparatus (e.g., angiography table 12). For example, the support plate fastening slots 2602, 2604 can engage with support plate attachment elements (e.g., straps 26 and / or clamps 28) that secure the patient support plate assembly 2600 to the table 12. Other mounting elements on support plate assembly 2600 may be used in conjunction with other types of support plate mounting elements.

[0171] 36, 37, and 44-48, the exemplary support plate assembly 2600 includes a support plate 2601 and a pivot plate 2640. The pivot plate 2640 operably couples the tilt guide housing 2330 and the support plate 2601. The exemplary support plate 601 includes a pivot plate connector 2606 configured to removably and pivotally couple the pivot plate 2640 to the support plate 2601. The pivot plate connector 2606 includes a connector base 2608 secured to the support plate 2601 and a removable connector cap 2610. The pivot plate 2640 includes a pivot plate bore 2646 disposed proximate one end of the pivot plate 2640. In this exemplary embodiment, the connector cap 2610 extends through the pivot plate bore 2646 of the pivot plate 2640 and is configured to releasably couple with the connector base 2608. For example, the connector cap 2610 may include one or more radially extending tabs 2612 that may be configured to engage corresponding slots 2614 in the connector base 2608. Rotating the connector cap 2610 approximately a quarter turn (e.g., clockwise) secures the connector cap 2610 to the connector base 2608, thereby securing the pivot plate 2640 to the support plate 2601. Similarly, rotating the connector cap 2610 approximately a quarter turn in the opposite direction (e.g., counterclockwise) releases the connector cap 2610 from the connector base 2608, thereby releasing the pivot plate 2640. The pivot plate 2640 is pivotable about a pivot axis 2648 that is substantially perpendicular to the top surface of the support plate assembly 2600 (and the top surface of the table 12) to provide a range of motion for lateral flexion of the patient's neck 30, as shown by arrow 2632 in FIG. 38 . One or more of the interface surfaces of the support plate assembly 2600 may include a lubricating material (e.g., low-friction polytetrafluoroethylene or polyoxymethylene plastic) or bearing elements such as rolling element bearings, for example, to facilitate adjustment of the head restraint mechanism 2300.

[0172] In this exemplary embodiment, the pivot plate 2640 includes a pivot lock slot 2618 that is shaped as substantially a radius relative to the pivot plate bore 2646 and is located near the opposite end of the pivot plate 2640 from the pivot plate bore 2646. The pivot lock slot 2618 includes a plurality of axially oriented teeth 2620 on one or both sides of the pivot lock slot 2618.

[0173] In this exemplary embodiment, the support plate 2601 includes a pivot lock assembly 2660 disposed on a downwardly extending flange 2650 proximate an edge of the support plate 2601. The pivot lock assembly 2660 includes a locking element, such as one or more teeth 2662, operably connected to a pivot lock button 2664. The one or more teeth 2662 can selectively engage one or more of the teeth 2620 of the pivot plate 2640, thereby fixing the angular position of the pivot plate 2640 relative to the support plate 2601. Pressing the pivot lock button 2664 disengages the one or more teeth 2662 from the one or more teeth 2620 of the pivot plate 2640, allowing the pivot plate 2640 to rotate about the axis 2648. One or more teeth 2662 of the pivot lock assembly 2660 can be rotated approximately 90 degrees to allow the one or more teeth 2662 to pass through the pivot lock slots 2618 of the pivot plate 2640, thereby enabling the pivot plate 2640 to be removed from the support plate 2601.

[0174] In this exemplary embodiment, the pivot plate 2640 includes a pivot plate bore 2670 disposed proximate to the pivot lock slot 2618 of the pivot plate 2640. The support plate 2601 includes a pivot slot 2672 including a flange 2674 on one or both sides of the pivot slot 2672. The pivot slot 2672 is shaped substantially as a radius relative to the pivot plate connector 2606. The exemplary support plate assembly 2600 includes a pivot plate connector cap 2610 configured to releasably and pivotally couple the pivot plate 2640 to the support plate 2601. In this exemplary embodiment, the connector cap 2610 extends through the pivot plate bore 2670 of the pivot plate 2640 and is configured to releasably couple the pivot slot 2672 to the support plate 2601. For example, the connector cap 2610 may include one or more radially extending tabs 2612 that may be configured to engage a corresponding flange 2674 in the support plate 2601. Rotating the connector cap 2610 approximately a quarter turn (e.g., clockwise) may secure the connector cap 2610 to the support plate 2601, thereby securing the pivot plate 2640 to the support plate 2601. Similarly, rotating the connector cap 2610 approximately a quarter turn in the opposite direction (e.g., counterclockwise) disengages the connector cap 2610 from the support plate 2601, thereby releasing the pivot plate 2640. In the exemplary embodiment, the pivot plate 2640 is generally held against the upper surface of the support plate 2601 by the connector cap 2610, but the pivot plate 2640 remains pivotable about a pivot axis 2648 to provide lateral flexion of the patient's neck 30, as shown in FIG. 38 .

[0175] 44-48 , the head restraint mechanism housing 2330 is releasably and selectively positionally coupled onto the pivot plate 2640. For example, the head restraint mechanism housing 2330 is longitudinally slidable relative to the longitudinal axis of the pivot plate 2640 and selectively lockable. In this illustrative embodiment, the pivot plate 2640 includes channels 2642, 2644 for mounting the head restraint mechanism housing 2330. Each channel 2642, 2644 further includes a series of indentations 2646, 2648. The head restraint mechanism housing 2330 includes one or more head restraint mechanism housing adjustment slots 2332, 2334 disposed on the channels 2642, 2644 of the pivot plate 2640. A head restraint housing push lever 2336 engages the indentations 2646, 2648 to selectively lock the head restraint mechanism housing 2330 in a desired longitudinal position relative to the pivot plate 2640. Depressing the head restraint housing push lever 2336 disengages the head restraint housing push lever 2336 from the recesses 2646 , 2648 , allowing the user to reposition the head restraint mechanism housing 2330 relative to the pivot plate 2640 .

[0176] 36-41 , a torso pad 2550 configured to facilitate vertical positioning of the patient's upper torso 24 is disposed on the support plate assembly 2600. The torso pad 2550 may be utilized to elevate the patient's upper torso 24. The exemplary torso pad 2550 includes an inflatable membrane 2552 disposed between the support plate assembly 2600 and the patient's upper torso 24 (e.g., above the support plate assembly 2600 and below the patient's upper torso 24). Inflating the inflatable membrane 2552 generally elevates the patient's upper torso 24 relative to the support plate assembly 2600. Deflating the inflatable membrane 2552 generally lowers the patient's upper torso 24 toward the support plate assembly 2600. The inflatable membrane 2552 may be operably coupled to a pressurized air source 2554 by appropriate tubing, valves, connectors, and the like. In some exemplary embodiments, pressurized air source 2554 may comprise a pressurized air supply system installed in the medical facility, hi other exemplary embodiments, pressurized air source 2554 may comprise a portable air source (e.g., a portable compressor or a portable compressed air tank).

[0177] A neck pad 2560 configured to facilitate vertical positioning of the patient's neck 30 is disposed on the support plate assembly 2600. The neck pad 2560 may be utilized to elevate and / or support the patient's neck 30. An exemplary neck pad 2560 includes an inflatable membrane 2562 disposed between the support plate assembly 2600 and the patient's neck 30 (e.g., above the support plate assembly 2600 and below the patient's neck 30). Inflating the inflatable membrane 2562 generally raises the patient's neck 30 relative to the support plate assembly 2600. Deflating the inflatable membrane 2562 generally lowers the patient's neck 30 toward the support plate assembly 2600. The inflatable membrane 2562 may be operably coupled to the pressurized air source 2554 by appropriate tubing, valves, connectors, etc.

[0178] 49 is an isometric view of an alternative exemplary head stabilization system 2000 in use with a patient 10, who is positioned in a generally lateral position, according to at least some embodiments of the present disclosure. While FIG. 49 shows the patient 10 positioned on its left side, the patient 10 may also be positioned on its left or right side.

[0179] 49-52, an overview of possible positioning of the patient's head 14 facilitated by the head stabilization system 2000 is provided to provide context for the following discussion. In general, the exemplary head stabilization system 2000 can be positioned and / or secured in any position and / or orientation within any combination of the ranges of motion described with reference to FIGS. 49-52 to position and / or stabilize the patient's head 14 in a desired position, such as for a procedure.

[0180] 50 is a side elevation view of an exemplary head stabilization system 2000 illustrating vertical positioning of a patient's head 14, according to at least some embodiments of the present disclosure. Generally, this articulation of the head restraint mechanism 2000 positions the patient's head 14 vertically up or down, as indicated by arrow 2076, in a plane generally perpendicular to the upper surface of the support plate assembly 2600. This vertical flexion motion is similar to the movement that occurs when a patient tilts their head to the right or left to place their ear against the shoulder 20, 22 on the same side without rotating the head 14. This exemplary head stabilization system 2000 facilitates approximately 30° of vertical flexion below center and 30° of vertical flexion above center, for a total range of approximately 60° of lateral flexion from bottom to top.

[0181] 51 is a head elevation view of an exemplary head stabilization system 2000 illustrating rotational positioning of a patient's head 14, according to at least some embodiments of the present disclosure. Generally, this articulation of the head harness 2200 relative to the head restraint mechanism 2300 provides for rotation of the patient's head 14 to the patient's right side or the patient's left side, as indicated by arrow 2078, in a plane generally perpendicular to the top surface of the support plate assembly 2600. This movement is generally similar to the movement that occurs when a patient attempts to rotate their head 14 left or right to say "no." This exemplary head stabilization system 2000 facilitates approximately 60° of right rotation and approximately 60° of left rotation, for a total rotation range of approximately 120°.

[0182] FIG. 52 is a plan view of an exemplary head stabilization system 2000 illustrating extension and flexion of the patient's neck 30, according to at least some embodiments of the present disclosure. Generally, this articulation of the head restraint mechanism 2300 provides posterior (i.e., extension) and anterior (i.e., flexion) extension and flexion of the patient's neck 30, as indicated by arrows 2080, in a plane generally transverse to the upper surface of the support plate assembly 2600. These movements generally resemble those that occur when a patient attempts to nod their head 14 up and down to say "yes." This exemplary head stabilization system 2000 facilitates approximately 25° of posterior neck extension (from neutral) and approximately 25° of anterior neck flexion (from neutral), for a full range of extension and flexion of approximately 50°. In some cases, traction on the patient's neck 30 may be advantageous. For example, the head restraint mechanism 2300 (via the head harness 2200) can apply a force to the patient's head 14 in a generally upward / cranial direction. Thus, the patient's neck 30 can be placed in tension in a generally longitudinal direction.

[0183] 53 and 54 are isometric views of an exemplary head harness 3200 positioned on a patient's head 14, according to at least some aspects of the present disclosure. In general, head harness 3200 is similar in structure and operation to head harnesses 200, 1200, 1500, and 2200 described above, and other head harnesses may be substituted for head harness 3200, or any features of head harness 3200 may be used, in various other exemplary embodiments according to the present disclosure. Like reference numbers refer to like components.

[0184] The head harness 3200 is configured to be secured to the patient's head 14 and to be (e.g., releasably) coupled to a head restraint mechanism. Generally, the exemplary head harness 3200 is configured to engage the patient's head 14 at the chin / chin region 38, the forehead region 40, and the rear region 42. In some exemplary embodiments, the head harness 3200 may be configured to securely engage the patient's head in a non-traumatically, non-penetrating manner (e.g., components of the head harness 3200 should not penetrate the patient's skin).

[0185] The exemplary head harness 3200 includes a chin strap portion 3202 configured to engage the patient's chin / jaw region 38. The chin strap portion 3202 facilitates control of the position of the patient's chin relative to the patient's neck 30. The chin strap portion 3202 includes a right chin strap portion 3204 and a left chin strap portion 3206, which extend forward and downward generally along the patient's mandible and hold a chin pad 3208 against the patient's chin / jaw region 38. The chin strap portions 3204, 3206 may be adjustable, such as by a buckle-type connector 3234.

[0186] The exemplary head harness 3200 includes one or more chin strap end connectors 3232. The right chin strap portion 3204 is connected to the chin strap end connector 3232 by a buckle-style connector 3234 with an integrated releasable catch 3268. The chin strap end connector 3232 and the buckle-style connector 3234 are secured together by the releasable catch 3268. When actuated by a user, the releasable catch 3268 releases the buckle-style connector 3234 from the chin strap end connector 3232. In some embodiments, the releasable catch 3268 may function as an emergency release that allows the patient 10 to quickly disconnect from the head harness 3200. For example, if the patient's airway is compromised, it may be desirable to quickly access the patient's mouth by removing the chin strap portion 3202 (e.g., by actuating the releasable catch 3268 as an emergency release of the chin strap). In some embodiments, the releasable catch 3268 may be configured for one-handed operation. The left chin strap portion 3206 is constructed in a substantially similar manner to provide an emergency release for the chin strap.

[0187] The exemplary head harness 3200 includes a halo portion 3210 configured to engage the patient's forehead 40 and the side portions 44, 46 of the patient's head 14. The halo portion 3210 includes a right halo strap portion 3212 and a left halo strap portion 3214. The halo strap portions 3212, 3214 extend front to back along the patient's head 14. The halo strap portions 3212, 3214 may be adjustable, such as by an adjustable buckle-type connector 3220, for adjusting the halo strap portions 3212, 3214 to provide a secure fit to an individual patient's head 14. The halo strap portions 3212, 3214 may include one or more strap retainers 3266 to secure loose ends of the halo strap portions 3212, 3214. At the front of the patient's head 14, the halo strap portions 3212, 3214 are coupled to a halo connector housing 3216 by a buckle-style connector 3220 having a releasable catch 3270. When actuated by a user, the releasable catch 3270 releases the buckle-style connector 3220 from the halo connector housing 3216. In some embodiments, the releasable catch 3270 may function as an emergency release that allows the patient 10 to quickly disconnect from the head harness 3200. In some embodiments, the releasable catch 3270 may be configured for one-handed operation.

[0188] In the exemplary head harness 3200, the halo portion 3210 is connected to the chin strap portion 3202 by a right ear cover 3224 and a left ear cover 3226. Each ear cover 3224, 3226 is generally shaped to fit over the patient's ear and is attached at an upper portion to the respective halo strap portion 3212, 3214 and connected at a lower portion to the respective chin strap portion 3204, 3206. In this exemplary embodiment, the ear covers 3224, 3226 are substantially rigid, and each halo strap portion 3212, 3214 passes through and is secured to the respective ear cover 3224, 3226. The chin strap portions 3204, 3206 are attached to the ear covers 3224, 3226. Each chin strap portion 3204, 3206 is connected to an adjustable buckle-type connector 3234 that is connected to a chin strap end connector 3232 that is connected to the respective ear cover 3224, 3226.

[0189] The exemplary head harness 3200 includes a rear support portion 3238, which may be in the form of a generally annular ring configured to be centrally positioned about the rear region 42 of the patient's head 14. The rear support portion 3238 is coupled to each of the halo strap portions 3212, 3214 such that the patient's head 14 is substantially circumscribed by the left halo strap portion 3214, the halo connector housing 3216, the right halo strap portion 3212, and the rear support portion 3238. The rear support portion 3238 and the halo connector housing 3216 are also connected by a head restraint portion 3240, which extends front to back across the center of the top of the patient's head 14.

[0190] In this exemplary embodiment, the head restraint portion 3240 includes a front head restraint strap portion 3241, a rear head restraint strap portion 3242, and a head restraint element 3244 disposed thereon. The head restraint portion 3240 may include radiopaque markings 3276, which may be useful, for example, for calibrating imaging equipment. The head restraint portion 3240 may be configured to be adjustable to provide a secure fit to an individual patient's head 14. In this exemplary embodiment, the head restraint element 3244 includes a head restraint strap adjustment knob assembly 3246 configured to adjust the head restraint strap portions 3241, 3242 to provide a secure fit to the patient's head 14. The front head restraint strap portion 3241 includes a cavity 3280 such that a plurality of teeth (not shown) are aligned along one side of the cavity 3280. The rear head restraint strap portion 3242 includes a cavity 3284 with a plurality of teeth (not shown) aligned along one side of the cavity 3284 when the strap portions 3241, 3242 are in their deployed positions, with the teeth of the rear strap portion 3242 aligned on the opposite side from the teeth of the front strap portion 3241. The adjustment knob assembly 3246 includes radially oriented gears (not shown) that engage with the teeth of the strap portions 3241, 3242 when the adjustment knob assembly 3246 is rotated, so that the strap portions 3241, 3242 move relative to one another, lengthening or shortening the length of the head restraint portion 3240 to provide a secure fit around the patient's head 14.

[0191] The exemplary head harness 3200 includes a connection element, such as a harness connector housing 3248, configured to releasably couple the head harness 3200 to a head restraint mechanism. In this exemplary embodiment, the harness connector housing 3248 is provided on the head restraint element 3244 and includes a cavity 3250 and a slot 3252 configured to releasably engage corresponding components of the head restraint mechanism. The slot 3252 extends through a wall 3256 that at least partially defines the cavity 3250. Additionally, the harness connector housing 3248 includes a latch 3257 releasable by an actuator, such as, for example, one or more finger tabs 3258 operably coupled to selectively secure the head harness 3200 (e.g., the harness connector housing 3248) to the head restraint mechanism 2300. The finger tabs 3258 function as an emergency release, allowing for quick removal of the head harness 3200 from the head restraint mechanism if necessary. In some embodiments, the finger tabs 3258 may be configured for one-handed operation.

[0192] The exemplary head harness 3200 includes a securement strap assembly 3290 that is positioned at the rear of the patient's head 14 and is intended to engage the base of the patient's skull to further secure the head harness 3200 to the patient's head 14. The securement strap assembly 3290 includes a right strap portion 3292, a left strap portion 3294, a vertical strap portion 3296, and a collector housing 3298. The collector housing 3298 is generally shaped like an inverted T. The right strap portion 3292, the left strap portion 3294, and the vertical strap portion 3296 are connected to the collector housing 3298. The vertical strap portion 3296 is generally connected to the rear support portion 3238 at a bottom central portion of the rear support portion 3238. The right strap portion 3292 is connected to the right ear cover 3224, and the left strap portion 3294 is connected to the left ear cover 3226. The strap portions 3292, 3294 generally connect to the bottom of the respective ear covers 3224, 3226. The right and left strap portions 3292, 3294 may be adjustable to facilitate securing the head harness 3200 to the patient's head 14.

[0193] In this exemplary embodiment, the chin strap portions 3204, 3206, halo strap portions 3212, 3214, and head restraint strap portions 3241, 3242 are constructed from a flexible but substantially inelastic material. The anchoring strap portions 3292, 3294, and 3296 are constructed from a soft, elastic material. The ear covers 3224, 3226, rear support portion 3238, and collector housing 3298 are constructed from a generally rigid material, such as a rigid polymer or composite material. In some exemplary embodiments, padding can be provided on various patient-contacting surfaces of the head harness 3200.

[0194] 55 and 56 are isometric views of an exemplary head harness 3300 placed on a patient's head 14, according to at least some aspects of the present disclosure. In general, head harness 3300 is similar in structure and operation to head harnesses 200, 1200, 1500, 2200, and 3200 described above, and in various other exemplary embodiments according to the present disclosure, head harness 3300 may be replaced by other head harnesses, or any features of head harness 3300 may be used. Like reference numbers refer to like components.

[0195] The head harness 3300 is configured to be secured to the patient's head 14 and to be (e.g., releasably) coupled to a head restraint mechanism. Generally, the exemplary head harness 3300 is configured to engage the patient's head 14 at the chin / chin region 38, the forehead region 40, and the posterior region 42. In some exemplary embodiments, the head harness 3300 may be configured to securely engage the patient's head in a non-traumatically, non-penetrating manner (e.g., components of the head harness 3300 should not penetrate the patient's skin).

[0196] The exemplary head harness 3300 includes a chin strap portion 3302 configured to engage the patient's chin / jaw region 38. The chin strap portion 3302 facilitates control of the position of the patient's chin relative to the patient's neck 30. The chin strap portion 3302 includes a right chin strap portion 3304 and a left chin strap portion 3306, which extend forward and downward generally along the patient's mandible and hold a chin pad 3308 against the patient's chin / jaw region 38. The chin strap portions 3304, 3306 may be adjustable, such as by a buckle-type connector 3334.

[0197] The exemplary head harness 3300 includes one or more chin strap end connectors 3332. The right chin strap portion 3304 is connected to the chin strap end connector 3332 by a buckle-style connector 3334 with an integrated releasable catch 3368. The chin strap end connector 3332 and the buckle-style connector 3334 are secured together by the releasable catch 3368. When actuated by a user, the releasable catch 3368 releases the buckle-style connector 3334 from the chin strap end connector 3332. In some embodiments, the releasable catch 3368 may function as an emergency release that allows the patient 10 to quickly disconnect from the head harness 3300. For example, if the patient's airway is compromised, it may be desirable to quickly access the patient's mouth by removing the chin strap portion 3302 (e.g., by actuating the releasable catch 3368 as an emergency release of the chin strap). In some embodiments, the releasable catch 3368 may be configured for one-handed operation. The left chin strap portion 3306 is constructed in a substantially similar manner to provide an emergency release for the chin strap.

[0198] The exemplary head harness 3300 includes a halo portion 3310 configured to engage the patient's forehead 40 and the lateral portions 44, 46 of the patient's head 14. The halo portion 3310 includes a right halo strap portion 3312 and a left halo strap portion 3314. The halo strap portions 3312, 3314 extend front to back along the patient's head 14. The halo strap portions 3312, 3314 may be adjustable, such as by an adjustable buckle-type connector 3320, for adjusting the halo strap portions 3312, 3314 to provide a secure fit to an individual patient's head 14. The halo strap portions 3312, 3314 may include one or more strap retainers 3366 to secure loose ends of the halo strap portions 3312, 3314. At the front of the patient's head 14, the halo strap portions 3312, 3314 are coupled to a halo connector housing 3316 by a buckle-style connector 3320 having a releasable catch 3370. When actuated by a user, the releasable catch 3370 releases the buckle-style connector 3320 from the halo connector housing 3316. In some embodiments, the releasable catch 3370 may function as an emergency release that allows the patient 10 to quickly disconnect from the head harness 3300. In some embodiments, the releasable catch 3370 may be configured for one-handed operation.

[0199] In the exemplary head harness 3300, the halo portion 3310 is connected to the chin strap portion 3302 by a right ear cover 3324 and a left ear cover 3326. Each ear cover portion 3324, 3326 is shaped to generally cover the patient's ear, with an upper portion attached to the respective halo strap portion 3312, 3314 and a lower portion connected to the respective chin strap portion 3304, 3306. In this exemplary embodiment, the ear covers 3324, 3326 are substantially rigid, and each halo strap portion 3312, 3314 passes through and is secured to the respective ear cover 3324, 3326. The chin strap portions 3304, 3306 are attached to the ear covers 3324, 3326. Each chin strap portion 3304, 3306 is connected to an adjustable buckle-type connector 3334 that is connected to a chin strap end connector 3332 that is connected to the respective ear cover 3324, 3326.

[0200] The exemplary head harness 3300 includes a rear support portion 3338, which may be in the form of a generally annular ring configured to be centrally positioned in the rear region 42 of the patient's head 14. The rear support portion 3338 is coupled to each of the halo strap portions 3312, 3314 such that the patient's head 14 is substantially circumscribed by the left halo strap portion 3314, the halo connector housing 3316, the right halo strap portion 3312, and the rear support portion 3338. The rear support portion 3338 and the halo connector housing 3316 are also connected by a head restraint portion 3340, which extends from front to back across the center of the top of the patient's head 14.

[0201] In this exemplary embodiment, the head restraint portion 3340 includes a front head restraint strap portion 3341, a rear head restraint strap portion 3342, and a head restraint element 3344 disposed thereon. The head restraint portion 3340 may include radiopaque markings 3376, which may be useful, for example, for calibrating imaging equipment. The head restraint portion 3340 may be configured to be adjustable to provide a secure fit to an individual patient's head 14. In this exemplary embodiment, the head restraint element 3344 includes a head restraint strap adjustment assembly 3346 configured to adjust the head restraint strap portions 3341, 3342 to provide a secure fit to the patient's head 14. The front head restraint strap portion 3341 includes a plurality of teeth 3382 aligned on an upper side of the strap portion 3341. The rear head restraint strap portion 3342 includes a plurality of teeth 3386 aligned on the bottom side of the strap portion 3342 such that when the strap portions 3341, 3342 are in their deployed positions, the teeth 3386 are aligned opposite the teeth 3382 of the front strap portion 3341. The adjustment knob assembly 3346 engages the teeth 3382, 3386 of the strap portions 3341, 3342 such that as the adjustment knob assembly 3346 is rotated, the strap portions 3341, 3342 move relative to one another to lengthen or shorten the length of the head restraint portion 3340 to provide a more secure fit around the patient's head 14.

[0202] The exemplary head harness 3300 includes a connection element, such as, for example, a harness connector housing 3348 configured to releasably couple the head harness 3300 to the head restraint mechanism 2300 .

[0203] The exemplary head harness 3300 includes a securement strap assembly 3390 located at the rear of the patient's head 14 and intended to engage the base of the patient's skull to further secure the head harness 3300 to the patient's head 14. The securement strap assembly 3390 includes a right strap portion 3392, a left strap portion 3394, a vertical strap portion 3396, and a collector housing 3398. The collector housing 3398 is generally shaped like an inverted T. The right strap portion 3392, the left strap portion 3394, and the vertical strap portion 3396 are connected to the collector housing 3398. The vertical strap portion 3396 is generally connected to the rear support portion 3338 at a bottom central portion of the rear support portion 3338. The right strap portion 3392 is connected to the right ear cover 3324, and the left strap portion 3394 is connected to the left ear cover 3326. The strap portions 3392, 3394 generally connect to the bottom of the respective ear cover portions 3324, 3326. The right and left strap portions 3392, 3394 may be adjustable to facilitate securing the head harness 3300 to the patient's head 14.

[0204] In this exemplary embodiment, the chin strap portions 3304, 3306, halo strap portions 3312, 3314, and head restraint strap portions 3341, 3342 are constructed from a flexible but substantially inelastic material. The anchoring strap portions 3392, 3394, and 3396 are constructed from a soft, elastic material. The ear cover portions 3324, 3326, rear support portion 3338, and collector housing 3398 are constructed from a generally rigid material, such as a rigid polymer or composite material. In some exemplary embodiments, padding can be provided on various patient-contacting surfaces of the head harness 3300.

[0205] 57 and 58 are isometric views of an exemplary head harness 3400 placed on a patient's head 14, according to at least some aspects of the present disclosure. In general, head harness 3400 is similar in structure and operation to head harnesses 200, 1200, 1500, 2200, 3200, and 3300 described above, and other head harnesses may be substituted for head harness 3400, or any features of head harness 3400 may be used, in various other exemplary embodiments according to the present disclosure. Like reference numbers refer to like components.

[0206] The head harness 3400 is configured to be secured to the patient's head 14 and to be (e.g., releasably) coupled to a head restraint mechanism. Generally, the exemplary head harness 3400 is configured to engage the patient's head 14 at the chin / chin region 38, the forehead region 40, and the posterior region 42. In some exemplary embodiments, the head harness 3400 can be configured to securely engage the patient's head in a non-traumatically, non-penetrating manner (e.g., components of the head harness 3400 cannot penetrate the patient's skin).

[0207] The exemplary head harness 3400 includes a chin strap portion 3402 configured to engage the patient's chin / jaw region 38. The chin strap portion 3402 facilitates control of the position of the patient's chin relative to the patient's neck 30. The chin strap portion 3402 includes a right chin strap portion 3404 and a left chin strap portion 3406, which extend forward and downward generally along the patient's mandible and hold a chin pad 3408 against the patient's chin / jaw region 38. The chin strap portions 3404, 3406 may be adjustable, such as by a buckle-type connector 3434.

[0208] The exemplary head harness 3400 includes one or more chin strap end connectors 3432. The right chin strap portion 3404 is connected to the chin strap end connector 3432 by a buckle-style connector 3434 with an integrated releasable catch 3468. The chin strap end connector 3432 and the buckle-style connector 3434 are secured together by the releasable catch 3468. When actuated by a user, the releasable catch 3468 releases the buckle-style connector 3434 from the chin strap end connector 3432. In some embodiments, the releasable catch 3468 may function as an emergency release, allowing the patient 10 to quickly disconnect from the head harness 3400. For example, if the patient's airway is compromised, it may be desirable to quickly access the patient's mouth by removing the chin strap portion 3402 (e.g., by actuating the releasable catch 3468 as an emergency release of the chin strap). In some embodiments, the releasable catch 3468 may be configured for one-handed operation. The left chin strap portion 3406 is constructed in a substantially similar manner to provide an emergency release for the chin strap.

[0209] The exemplary head harness 3400 includes a halo portion 3410 configured to engage the patient's forehead 40 and the side portions 44, 46 of the patient's head 14. The halo portion 3410 includes a right halo strap portion 3412 and a left halo strap portion 3414. The halo strap portions 3412, 3414 extend front to back along the patient's head 14. The halo strap portions 3412, 3414 may be adjustable, such as by an adjustable buckle-type connector 3420, for adjusting the halo strap portions 3412, 3414 to provide a secure fit to an individual patient's head 14. The halo strap portions 3412, 3414 may include one or more strap retainers 3466 to secure loose ends of the halo strap portions 3412, 3414. At the front of the patient's head 14, the halo strap portions 3412, 3414 are coupled to a halo connector housing 3416 by a buckle-style connector 3420 having a releasable catch 3470. When actuated by a user, the releasable catch 3470 releases the buckle-style connector 4320 from the halo connector housing 3416. In some embodiments, the releasable catch 3470 may function as an emergency release that allows the patient 10 to quickly disconnect from the head harness 3400. In some embodiments, the releasable catch 3470 may be configured for one-handed operation.

[0210] In the exemplary head harness 3400, the halo portion 3410 is connected to the chin strap portion 3402 by right and left ear covers 3424 and 3426. Each ear cover 3424, 3426 is generally shaped to fit over the patient's ear and is attached at an upper portion to the respective halo strap portion 3412, 3414 and connected at a lower portion to the respective chin strap portion 3404, 3406. In this exemplary embodiment, the ear covers 3424, 3426 are substantially rigid, and each halo strap portion 3412, 3414 passes through and is secured to the respective ear cover 3424, 3426. The chin strap portions 3404, 3406 are attached to the ear covers 3424, 3426. Each chin strap portion 3404, 3406 is connected to an adjustable buckle-type connector 3434 that is connected to a chin strap end connector 3432 that is connected to the respective ear cover 3424, 3426.

[0211] The exemplary head harness 3400 includes a rear support portion 3438, which may be in the form of a generally annular ring configured to be centrally positioned on the rear region 42 of the patient's head 14. The rear support portion 3438 is coupled to each of the halo strap portions 3412, 3414, such that the patient's head 14 is substantially circumscribed by the left halo strap portion 3414, the halo connector housing 3416, the right halo strap portion 3412, and the rear support portion 3438. The rear support portion 3438 and the halo connector housing 3416 are also connected by a head restraint portion 3440, which extends front to back across the center of the top of the patient's head 14.

[0212] In this exemplary embodiment, the head restraint portion 3440 includes front and rear head restraint strap portions 3442 and a head restraint element 3444 disposed thereon. The head restraint portion 3440 may include radiopaque markings 3476, which may be useful, for example, for calibrating imaging equipment. The head restraint portion 3440 may be configured to be adjustable to provide a secure fit to an individual patient's head 14. In this exemplary embodiment, the head restraint element 3444 includes a front head restraint strap adjustment assembly 3446 configured to allow adjustment of the front head restraint strap portion 3441. The head restraint element 3444 also includes a rear head restraint strap adjustment assembly 3450 configured to allow adjustment of the rear head restraint strap portion 3442. In this exemplary embodiment, the head restraint element 3444 may be adjusted to provide a secure fit to the patient's head 14 by adjusting the head restraint strap portions 3441, 3442 using the head restraint strap adjustment knob assemblies 3446, 3450.

[0213] The exemplary head harness 3400 includes a connection element, such as, for example, a harness connector housing 3448 configured to releasably couple the head harness 3400 to the head restraint mechanism 2300 .

[0214] The exemplary head harness 3400 includes a securement strap assembly 3490 positioned at the rear of the patient's head 14 and intended to engage the base of the patient's skull to further secure the head harness 3400 to the patient's head 14. The securement strap assembly 3490 includes a right strap portion 3492, a left strap portion 3494, a vertical strap portion 3496, and a collector housing 3498. The collector housing 3498 is generally shaped like an inverted T. The right strap portion 3492, the left strap portion 3494, and the vertical strap portion 3496 are connected to the collector housing 3498. The vertical strap portion 3496 is generally connected to the rear support portion 3438 at a bottom central portion of the rear support portion 3438. The right strap portion 3492 is connected to the right ear cover 3424, and the left strap portion 3494 is connected to the left ear cover 3426. The strap portions 3492, 3494 generally connect to the bottom of the respective ear covers 3424, 3426. The right and left strap portions 3492, 3494 may be adjustable to facilitate securing the head harness 3400 to the patient's head 14.

[0215] In this exemplary embodiment, the chin strap portions 3404, 3406, halo strap portions 3412, 3414, and head restraint strap portions 3441, 3442 are constructed from a flexible but substantially inelastic material. The anchoring strap portions 3492, 3494, and 3496 are constructed from a soft, elastic material. The ear covers 3424, 3426, rear support portion 3438, and collector housing 3498 are constructed from a generally rigid material, such as a rigid polymer or composite material. In some exemplary embodiments, padding can be provided on various patient-contacting surfaces of the head harness 3400.

[0216] While the present invention has been illustrated by the description of specific embodiments thereof, and the embodiments have been described in considerable detail, it is in no way intended to restrict or limit the scope of the appended claims to such details. The various features described herein can be used alone or in any combination within and between the various embodiments. Additional advantages and modifications will be readily apparent to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope or spirit of the general inventive concept. [Explanation of symbols]

[0217] 10 patients 12 Angiography Table 14 Patient's head 16, 18 Imaging device 20, 22 Patient's shoulder 24 Patient's upper torso 26 Strap 28 Clamp 30 Patient's neck 38 Chin / Jaw Area 40 forehead area 42 Posterior area 44, 46 Side part 48 C1~C2 puncture site 100, 1400, 2000 Head Stabilization System 200, 1200, 1500, 2200 Head Harness 202, 1202, 1502, 2202 chin strap part 204, 1504, 2204 Right chin strap 206, 1506, 2206 Left chin strap 208, 1508, 2208 Chin pad 210, 1210, 1510, 2210 halo part 212, 1512, 2212 Right halo strap part 214, 1514, 2214 Left halo strap part 216, 1516 Harrow adjustment mechanism 218 Halo adjustment knob 220 Right harrow adjustment hinge 222 Left harrow adjustment hinge 224, 1224, 1524, 2224 Right halo stabilizer 226, 1226, 1526, 2226 Left halo stabilizer 228 Harrow Fastener 232, 1232 Hello strap part 234, 1234 Chin strap part 236, 1236, 1311, 2218, 2236 release button 238, 1538, 2238 Rear support part 240, 1240, 1540, 2240 Head restraint part 242 Head restraint strap part 244, 1244, 1544, 2244 Head restraint element 246 Head restraint strap adjustment knob 248, 1248, 1548, 2248 Harness Connector Housing 250, 1250, 1550, 1750, 2250, 2280, 2338 hollow 252, 1252, 1552, 2252 slots 254, 312, 1610, 1625, 1635, 1641, 1648, 1650, 1670, 1672, 2316, 2318, 2324 Toothed surface 256, 1256, 2256 Wall 257, 1557, 2257 latches 258, 1558, 2258 Finger Tabs 300, 300a, 1300, 1600, 2300 Head restraint mechanism 302, 302a, 1302, 1632, 2302 Harness connector assembly 304, 304a, 1636, 2304 harness connector body 306, 306a, 1306, 1646, 2306 Harness connector stopper 308, 1308, 1638, 2314 Harness connector shaft 310, 310a, 1310, 1640 harness connector knob 314, 314a, 1314, 1602, 2320 Inclined guide 314b through hole 316, 316a, 1316, 2322 Inclined guide slot 318 Swivel Arm 320 Swivel Arm Bore 324 Swivel Lock Assembly 326, 620, 1582, 2620 teeth 328 Swivel adjustment knob 330, 2650 flange 332, 334 Inclined guide adjustment slot 336, 338 Inclined guide adjustment knob 400, 402, 1700, 1800 Shoulder restraints 404 Shoulder restraint part 406 Base 407 Shoulder restraint connection element 408 Longitudinal Slot 409 Horizontal Slot 410 Latch assembly 412 Housing 414 Handle 416 Locking Elements 418 Link Mechanism 420 Boss 422 flange 424 Surface (support plate holding element) 426 Shoulder Pads 500 Chest Elevator 502 Membrane 504 Pressurized Air Source 600, 1410, 2600 Support plate assembly 601, 2601 Support plate 602, 604, 2602, 2604 Support plate fastening slots 606 Head Restraint Mechanism Connector 608, 2608 connector base 610, 2610 Connector Cap 612, 2612 tabs 614, 618 slots 616 Swivel lock engagement element 622, 624 Shoulder restraint connection element 626 Horizontal Slot

Claims

1. a head restraint mechanism configured to be operably disposed on a patient support apparatus; a head harness configured to engage the patient's head, including engaging the chin or jaw region, the forehead region, and the rear region of the patient's head; 1. A head stabilization system comprising: the head harness is removably attachable to and at least partially supported by the head restraint mechanism; 1. A head stabilization system comprising: a head restraint mechanism configured to stabilize the head harness relative to the patient support apparatus and configured to selectively allow lateral flexion of the patient's neck, lateral rotation of the patient's head, and extension and flexion of the patient's neck.

2. the head stabilization system further comprising a pivot arm configured to be operably positioned on the patient support apparatus; the head restraint mechanism is coupled to the pivot arm; The head stabilization system of claim 1 , wherein pivoting the pivot arm selectively pivots the head restraint mechanism relative to the patient support apparatus.

3. the head stabilization system further comprising a patient support plate secured to the patient support apparatus and configured to receive at least a portion of a patient thereon; The head stabilization system of claim 1 , wherein the head restraint mechanism is disposed on the patient support plate.

4. The head stabilization system of claim 1 , further comprising a shoulder restraint comprising a shoulder restraint portion configured to engage the patient's shoulder.

5. 10. The head stabilization system of claim 1, further comprising a torso pad configured to facilitate vertical positioning of the patient's upper torso relative to the head restraint mechanism.

6. 10. The head stabilization system of claim 1, further comprising a neck pad configured to facilitate vertical positioning of the patient's neck relative to the head restraint mechanism.

7. The head stabilization system of claim 1 , wherein the head harness and head restraint mechanism are configured to stabilize the head of the patient with the patient in a generally supine position.

8. The head stabilization system of claim 1 , wherein the head harness and head restraint mechanism are configured to stabilize the head of the patient in a generally sideways position.

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