WO2023213365A1 - A head angle adjustment device and a method for forming a head immobilization cast - Google Patents

A head angle adjustment device and a method for forming a head immobilization cast Download PDF

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Publication number
WO2023213365A1
WO2023213365A1 PCT/DK2023/050100 DK2023050100W WO2023213365A1 WO 2023213365 A1 WO2023213365 A1 WO 2023213365A1 DK 2023050100 W DK2023050100 W DK 2023050100W WO 2023213365 A1 WO2023213365 A1 WO 2023213365A1
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WO
WIPO (PCT)
Prior art keywords
head
angle adjustment
brace
support
rest
Prior art date
Application number
PCT/DK2023/050100
Other languages
French (fr)
Inventor
Erik Langelund
Original Assignee
Candor Aps
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Candor Aps filed Critical Candor Aps
Publication of WO2023213365A1 publication Critical patent/WO2023213365A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/04—Positioning of patients; Tiltable beds or the like
    • A61B6/0407—Supports, e.g. tables or beds, for the body or parts of the body
    • A61B6/0421—Supports, e.g. tables or beds, for the body or parts of the body with immobilising means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
    • A61B90/18—Retaining sheets, e.g. immobilising masks made from a thermoplastic material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B2090/101—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis for stereotaxic radiosurgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N2005/1092—Details
    • A61N2005/1097—Means for immobilizing the patient

Definitions

  • the invention relates to a a head angle adjustment device for use with radiation therapy equipment.
  • the head angle adjustment device comprises a board having an upper support surface arranged for supporting a radiation therapy patient.
  • the invention also relates to a method for forming a head immobilization cast for a radiation therapy patient by means of a head angle adjustment device.
  • a positioning device comprising a angle adjustable head rest by means of which the patient’s head can be tilted to a desired position before a mask is formed over the patient’s face and the positioning device to fixate the patient’s head in the desired position.
  • the head rest is made of a low-density material it will still have a relatively high radiation absorption and the positioning device takes up space around the patient’s head which may be disadvantageous in relation to the radiation therapy equipment.
  • a multidirectional adjustable head fixing device comprises a head support connected at a first end to an operating bed through a multidirectional linkage assembly and supported at another end by an adjustment rod enabling that the tilt angle of a patient’s head may be adjusted.
  • the head support is made of a low- density material, it will still have a relatively high radiation absorption and the head support, and the adjustment rod takes up space around the patient’s head which may be disadvantageous in relation to radiation therapy equipment.
  • An object of the invention is therefore to provide for a better head angle adjustment technique in relation to radiation therapy fixation.
  • the invention provides for a head angle adjustment device for use with radiation therapy equipment.
  • the head angle adjustment device comprises a board having an upper support surface arranged for supporting a radiation therapy patient, wherein a head brace is protruding from a head end of the board, and wherein an upper brace surface of the head brace is arranged above the upper support surface.
  • the head angle adjustment device further comprises a support structure releasably attached to the head brace, wherein the support structure comprises angle adjustment means.
  • the head angle adjustment device comprises a head rest having a first end supported by the board and a second end supported by the angle adjustment means, wherein the angle adjustment means are arranged to adjust a tilt angle of the head rest.
  • Providing the board with a head brace protruding from a head end of the board and having an upper brace surface being displaced upwards in relation to the upper support surface of the board - advantageously so that the head brace is extending around and close to the vertical middle of a supine patient’s head - is advantageous in that the entire back and front of the head of a patient - placed on the head angle adjustment device with the head in the head brace - is free and accessible for radiation therapy equipment.
  • Attaching the support structure comprising the angle adjustment means to the head brace is advantageous in that this ensures better support of the second end of the head rest so that the angle adjustment means may easily adjust the tilt angle of the head rest.
  • attaching the support structure releasably to the head brace is advantageous in that the support structure and the head rest hereby easily can be removed from the head brace once a head cast have been made so that the support structure and the head rest may not be in the way during subsequent radiation therapy or reduce the effect of the radiation therapy due to radiation absorption.
  • angle adjustment means is to be understood as any kind of angle adjuster capable of adjusting a tilt angle of the head rest of a head angle adjustment device. I.e., the term includes any kind of adjusting bolt, adjusting screw, adjustable wedge arrangement, adjustable or interchangeable spacers or other or any combination thereof which may be manually and/or automatically driven.
  • any reference to orientation throughout this document - i.e. up, down, over, under, top, bottom, side etc. - refers to the head angle adjustment device during normal use - i.e., where the board is placed flat on a substantially horizontal surface so that a patient may be placed laying down on the board in a supine position with the back of the head resting on the head rest and so that any vertical displacement of the head rest will cause the angle of the patient’s head to change.
  • the first end of the head rest is supported by the board at one or more board support contact points and wherein the angle adjustment means are arranged to adjust the tilt angle of the head rest by rotating the head rest around the one or more board support contact points.
  • Forming the equipment so that the angle adjustment means rotates the head rest around board support contact points is advantageous in that rotational displacement - i.e., tilt angle displacement - is relatively easy to design - at least compared to linear vertical displacement - and in that this entails a tilting displacement of the head rest which corresponds to the natural tilt of the head and thereby reduces discomfort of the patient using the head angle adjustment device.
  • the angle adjustment means comprises a rotatable support device arranged to support the second end of the head rest and wherein the rotatable support device comprises at least two support surfaces arranged at different distances from a rotational axis of the rotatable support device.
  • Forming the angle adjustment means by means of a rotatable support device comprising different support surfaces arranged at different distances from the rotational axis of the support device is advantageous in that the tilt angle of the head rest hereby easily can be adjusted in predetermined increment by rotating the support device so that the head rest is supported by a new higher or lower support surface.
  • the support structure further comprises a releasable rotation locking device arranged to lock the rotatable support device against rotation in relation to the support structure.
  • a releasable rotation locking device arranged to lock the rotatable support device against rotation in relation to the support structure.
  • the head angle adjustment device further comprises a support pillow placed on the head rest.
  • Making the head angle adjustment device comprise a support pillow placed on the head rest is advantageous in that this increases the comfort of the patient and ensures a larger contact surface which in turn will further prevent the patient from moving during the casting process.
  • the head rest comprises at least one tilt shaft or at least tilt shaft rest arranged at the first end of the head rest, wherein the board comprises the other of the at least one tilt shaft and the at least one tilt shaft rest and wherein the at least one tilt shaft is rotatably supported in the at least one tilt shaft rest.
  • head rest comprise tilt shafts or tilt shaft rests rotatably supported in/supporting corresponding tilt shafts or tilt shaft rests of the board is advantageous in that the head rest and the tilt motion hereby is better supported and more precise.
  • the support structure is releasably attached to an underside of the head brace.
  • Attaching the support structure releasably to the underside of the head brace is advantageous in that this leaves the upper brace surface of the head brace free for attaching heat-formable cast material to the head brace, while it is easy to remove (and attach) the support structure without interfering with the heat-formable cast material.
  • the upper brace surface of the head brace is substantially parallel with the upper support surface of the board.
  • Forming the upper brace surface of the head brace substantially parallel with the upper support surface of the board is advantageous in that this enables that the head cast may be formed more symmetrically and with better support no matter if the head is tilted forward, backward or maintained in a straight position during casting. Furthermore, the parallel arrangement ensures that the head brace is less in the way for radiation therapy equipment.
  • the invention further provides for a method for forming a head immobilization cast for a radiation therapy patient by means of a head angle adjustment device.
  • the method comprises the steps of:
  • Adjusting the tilt angle of the patient’s head by adjusting the tilt angle of the head rest is advantageous in that it hereby is possible to form the cast while the patient’s head is maintained in an angle that is better suited for the subsequent radiation therapy. And removing the support structure and the head rest from the head brace after the heat-formable back cast has hardened is advantageous in that the support structure and the head rest will not absorb radiation or be in the way during subsequent radiation therapy.
  • the tilt angle of the head rest could be adjusted after the patient is placed on the board - either before or after the heat-formable back cast material is connected to the head brace and/or the head rest can be connected to the board before the support structure is connected to the head brace or these two steps can be performed substantially simultaneously.
  • the method further comprises the step of pressing a sheet of heat-formable front cast material down onto the face of the radiation therapy patient while the back of the patient’s head is supported by the hardened heat- formable back cast material and connecting the heat-formable front cast material to the head brace.
  • Forming a front-of-the-head cast while the patient’s head is resting in the back-of- the-head cast is advantageous in that this ensures better and more precise fixation of the patient’s head during the forming and hardening of the front-of-the-head cast. Furthermore, immobilizing the patient’s head by both a back-of-the-head cast and a front-of-the-head cast ensures a very strong and precise fixation of the patient’s head during subsequent radiation therapy.
  • the method further comprises placing the head rest so that so that the second end of the head rest is supported by a rotatable support device of the angle adjustment means, wherein the rotatable support device comprises at least two support surfaces arranged at different distances from a rotational axis of the rotatable support device.
  • the tilt angle of the head rest is adjusted by rotating the rotatable support device.
  • Adjusted tilt angle of the head rest by rotating the rotatable support device is a simple and efficient way of adjusting the tilt angle in fixed increments ensuring that any adjustments setting can easily and securely be reproduced.
  • the method further comprises locking the rotatable support device against rotation in relation to the support structure by means of a releasable rotation locking device before placing the radiation therapy patient with the back of the patient’s head placed on the heat-formable back cast material.
  • Locking the rotatable support device against rotation in relation to the support structure by means of a releasable rotation locking device is advantageous in that it hereby is possible to lock the support device against rotation in relation to the support structure in a simple and efficient manner before movements of the patient’s head could alter the position.
  • the head angle adjustment device is a head angle adjustment device according to any of the previously discussed head angle adjustment devices.
  • fig. 1 illustrates a board, as seen from the top
  • fig. 2 illustrates a board, as seen from the side
  • fig. 3 illustrates a board, as seen in an isometric view
  • fig. 4 illustrates a head rest, as seen from the top
  • fig. 5 illustrates a head rest, as seen from the side
  • fig. 6 illustrates a head rest, as seen in an isometric view
  • fig. 7 illustrates a support structure, as seen from the bottom
  • fig. 8 illustrates a support structure, as seen from the side
  • fig. 9 illustrates a support structure, as seen from the end, fig.
  • FIG. 10 illustrates a support structure, as seen in an isometric view
  • fig. 11 illustrates a head angle adjustment device, as seen from the top
  • fig. 12 illustrates a head angle adjustment device, as seen from the side
  • fig. 13 illustrates a head angle adjustment device, as seen in an isometric view
  • fig. 14 illustrates a head angle adjustment device with heat- formable back cast material, as seen from the top
  • fig. 15 illustrates a head angle adjustment device with heat- formable back cast material, as seen from the side
  • fig. 16 illustrates a patient placed on a head angle adjustment device with heat-formable back cast material, as seen from the side
  • fig. 17 illustrates a patient fixated by heat-formable back cast material and heat-formable front cast material, as seen from the side.
  • Fig. 1 illustrates a board 2, as seen from the top
  • fig. 2 illustrates a board 2, as seen from the side
  • fig. 3 illustrates a board 2, as seen in an isometric view.
  • the board 2 has an upper support surface 3 on which a patient may be laying during casting of back and/or front casts of the patient’s head and e.g., during subsequent radiation therapy.
  • the board 2 comprises a head brace 5 which is protruding from a head end 6 of the board 2.
  • the head brace and thereby the upper brace surface 7 of the head brace 5 is vertically displaced in relation to the upper support surface 3 so that the head brace is positioned substantially at the vertical middle or at least closer to the vertical middle of the head of a patient lying on the board 2 with the head positioned in the head brace 5 as seen in figs. 16 and 17.
  • the upper brace surface 7 of the head brace 5 is vertically displaced approximately 80 mm in relation to the upper support surface 3.
  • the upper brace surface 7 of the head brace 5 could be vertically displaced less in relation to the upper support surface 3 - such as 70 mm, 60 mm, 50 mm, 40 mm or even less or the upper brace surface 7 could be vertically displaced more - such as 90 mm, 100 mm, 110 mm or even more.
  • the board 2 including the head brace 5 are integrally formed and made entirely of a low-density Carbon-fiber-reinforced polymer material that is strong and a has a very low radiation absorption.
  • the board 2 and/or parts of the board could also or instead be made of fiberglass reinforced resin, ceramic, stainless steel or another metal, a composite material or other or any combination thereof and/or the bord 2 could be formed by more interconnected parts.
  • Fig. 4 illustrates a head rest 10, as seen from the top
  • fig. 5 illustrates a head rest 10, as seen from the side
  • fig. 6 illustrates a head rest 10, as seen in an isometric view.
  • the head rest 10 has a first end 11 arranged to be supported by the board 2 and a second end 12 arranged to be supported by angle adjustment means 9 of a support structure 8 as disclosed in relation to figs. 11-16.
  • the head rest 10 is disclosed without a support pillow 18 but as disclosed in figs. 11-16 a support pillow 18 could in another embodiment be placed on the head rest 10.
  • the head rest 10 is provided with three sets of connection holes 28 enabling that the support pillow 18 can be connected to the head rest 10 in three different positions.
  • Fig. 7 illustrates a support structure 8, as seen from the top
  • fig. 8 illustrates a support structure 8, as seen from the side
  • fig. 8 illustrates a support structure 8, as seen from the end
  • fig. 10 illustrates a support structure 8, as seen in an isometric view.
  • the support structure 8 comprises a support brace 29 having a shape substantially corresponding to the shape of the head brace 5 of the board 2.
  • the support brace 29 could be shaped differently and different from the head brace 5 e.g., to reduce material use, to enhance functionality or other.
  • the support brace 29 is arranged to be releasably attached to the head brace 5 by means of connection tracks 30 arranged to engage retainer pins 31 on the underside 21 of the head brace 5 as disclosed in figs. 12-13.
  • the support brace 29 could also or instead be releasably attached to the head brace 5 through other means - such as a key and spline arrangement or another type of interlocking geometry that would allow the support brace 29 to easily be slid onto the head brace 5, or the support brace 29 could also or instead be releasably attached to the head brace 5 through thumbscrews, bolt or screws, a quick-lock or snap-lock arrangement or any other type of connection arrangement that would allow the support brace 29 to be releasably attached to the head brace 5.
  • other means such as a key and spline arrangement or another type of interlocking geometry that would allow the support brace 29 to easily be slid onto the head brace 5, or the support brace 29 could also or instead be releasably attached to the head brace 5 through thumbscrews, bolt or screws, a quick-lock or snap-lock arrangement or any other type of connection arrangement that would allow the support brace 29 to be releasably attached
  • the support structure 8 comprises a support bridge 32 bridging the underside of the support brace 29 and the support structure 8 comprises angle adjustment means 9 which in this embodiment are arranged to extend across the support bridge 32.
  • the angle adjustment means 9 comprise a rotatable support device 14 arranged to support the second end 12 of the head rest 10 as disclosed in relation to figs. 11-16.
  • the rotatable support device 14 comprises six support surfaces 15 arranged at different distances from the rotational axis 16 of the support device 14 so that the second end 12 of the head rest 10 can be vertically supported at six different heights depending on the rotational orientation of the support device 14 so that in this embodiment the angle adjustment means 9 are arranged adjust the tilt angle A of the head rest 10 between six different tilt angles - i.e., in this embodiment the support device 14 is formed as a polygonal eccentric.
  • the support device 14 could comprise more different support surfaces 15 - such as eight, ten, thirteen or even more - or the support device 14 could comprise fewer different support surfaces 15 - such as five, three or even one if the support device 14 was formed as a smooth eccentric.
  • angle adjustment means 9 could also or instead be enabled by a support spindle (not shown) engaging a threaded through hole in the support bridge 32 so that the spindle could be rotated to vertically displace the second end 12 of the head rest 10
  • the angle adjustment means 9 could also or instead be enabled by means of a wedge (not shown) arranged between the support bridge 32 and the second end 12 of the head rest 10 so that the wedge could be linearly displaced to vertically displace the second end 12 of the head rest 10 and/or the angle adjustment means 9 could be enabled in numerous other ways known to the skilled person.
  • the support structure 8 also comprises a releasable rotation locking device 17 arranged to lock the support device 14 against rotation in relation to the support structure 8.
  • the locking device 17 comprises a linearly displaceable spring-biased locking pin 33 extending through a hole in the support bridge 32 to engage the support device 14 so that when the locking pin 33 is manually pulled out of engagement with the support device 14, the support device 14 can be freely rotated.
  • the locking device 17 could be formed in numerous other ways - such as by means of a locking screw, by means of a spring-biased locking ball arranged on the support bridge 32 to engage corresponding locking indentations on the support device 14 or other or any combination thereof.
  • the support device 14 is further provided with a position disc 34 comprising visual indication of the tilt angle A when the support device 14 is rotated to any given position, making it easier to detect the actual tilt angle, to document settings, instruct personnel and other.
  • the support structure 8 is further provided with handles 35 to enable easier attachment and dismounting of the support structure 8 on and from the head brace 5.
  • the head rest 10 and the support structure 8 are predominantly made of a low-density Carbon-fiber-reinforced polymer material that is strong and has a very low radiation absorption.
  • the head rest 10 and the support structure 8 could in another embodiment also or instead be made of fiberglass reinforced resin, ceramic, stainless steel or another metal, a composite material or other or any combination thereof.
  • Fig. 11 illustrates a head angle adjustment device 1, as seen from the top
  • fig. 12 illustrates a head angle adjustment device 1, as seen from the side
  • fig. 13 illustrates a head angle adjustment device 1, as seen in an isometric view.
  • the first end 11 of the head rest 10 is supported by the board 2 at board support contact points 13 in the form of tilt shafts 19 protruding from the first end 11 of the head rest 10 and engaging corresponding tilt shaft rests 20 on the board 2 so that the head rest 10 may rotate in relation to the board 2 without being linearly displaced in any horizontal direction.
  • the tilt shaft rests 20 are open at the top, so that the head rest 10 may easily be connected to or released from the board 2.
  • the tilt shafts 19 could be arranged on the board 2 and the tilt shaft rests 20 could be arranged on the head rest 10.
  • first end 11 of the head rest 10 and the board 2 could be provided with other forms of protrusions engaging other forms of indentions or grooves to ensure that the head rest 10 may rotate in relation to the board 2 without being linearly displaced in any horizontal direction.
  • the first end 11 of the head rest 10 is first attached to the board 2 after which the support structure 8 is attached to the head brace 5 by an operator sliding the support structure 8 in under the head brace 5 so that the connection tracks 30 of the support structure 8 engages the retainer pins 31 on the underside 21 of the head brace 5 and so that the second end 12 of the head rest 10 is supported by the angle adjustment means 9 of the support structure 8.
  • the connection tracks 30 could be formed on the head brace 5 and the retainer pins 31 could be arranged on a topside of the support structure 8.
  • the support structure 8 could be connected to the head brace 5 first after which the head rest 10 is mounted, or the support structure 8 and the head rest 10 could be formed as a single unit that could be mounted in a single operation. After use the support structure 8 and the head rest 10 would be removed in a similar fashion by revering the mounting steps.
  • the head rest 10 is provided with a support pillow 18 to increase the comfort of the user and in this embodiment the angle adjustment means 9 is adjusted so that the head rest 10 is substantially flush with the upper support surface 3 of the board 2 forming a tilt angle A of approximately 0°.
  • the tilt angle A of the head rest 10 can in this embodiment be adjusted to -2.5°, -5°, -7.5°, +3° and +6° in relation to the current position of 0°.
  • the angle adjustment means 9 could obviously be arranged to tilt the head rest 10 to different tilt angles A - such as -1°, - 6°, -10° or even more, and/or +1°, +4.5°, +11° or even more.
  • the angle adjustment means 9 could be arranged to adjust the tilt angle A stepless within a range of -30° to +30°, within a range of -20° to +20°, within a range of -18° to +12° or within another rage.
  • Fig. 14 illustrates a head angle adjustment device 1 with heat-formable back cast material 23, as seen from the top and fig. 15 illustrates a head angle adjustment device 1 with heat-formable back cast material 23, as seen from the side.
  • Fig. 16 illustrates a patient 4 placed on a head angle adjustment device 1 with heat-formable back cast material 23, as seen from the side and fig. 17 illustrates a patient 4 fixated by heat-formable back cast material 23 and heat-formable front cast material 25, as seen from the side.
  • the head angle adjustment device 1 is used for forming a head immobilization cast 22 for a radiation therapy patient 4 by first connecting the head rest 10 to the board 2 after which the support structure 8 is releasably attached to the head brace 5 so that the first end 11 of the head rest 10 is supported by the board 2 and the second end 12 of the head rest 10 is supported the angle adjustment means 9 of the support structure 8.
  • a radiation therapy patient 4 is then placed on the upper support surface 3 of the board 2 in a supine position with the patient’s head 24 placed in the head brace 5 and with the back 27 of the patient’s head 24 placed on the head rest 10 after which the tilt angle A of the head rest 10 is adjusted by means of the angle adjustment means 9 to position the patient’s head 24 in an desired angle in relation to the subsequent stereotactic radiosurgery.
  • the patient’s head 24 is removed from the head brace 5 and the head rest 10, and a sheet of soft and formable heat-formable back cast material 23 is attached to the upper side of the head brace 5 so that the heat-formable back cast material 23 is suspended across the head brace 5 as disclosed in figs. 14 and 15.
  • the patient 4 is again placed on the upper support surface 3 of the board 2 in a supine position with the back 27 of the patient’s head 24 placed on the heat-formable back cast material 23 and the heat-formable back cast material 23 is deformed by moving the patient’s head 24 downwards until the head 24 rests on the head rest 10 again.
  • the heat-formable back cast material 23 is allowed to harden over a period of time after which the support structure 8 and the head rest 10 is removed from the head brace 5 and the patient’s head 24 is fixed in and supported by the hardened back cast material 23 and ready for radiation therapy.
  • the heat-formable back cast material 23 could be attached to the head brace 5 right after the support structure 8 and the head rest 10 was attached to the board 2, and the tilt angle A of the head rest 10 would be adjusted by means of the angle adjustment means 9 after the heat- formable back cast material 23 is deformed by moving the patient’s head 24 downwards until the head 24 rests on the head rest 10.
  • the procedure could further include pressing a sheet of heat-formable front cast material 25 down onto the front i.e., the face 26 of the radiation therapy patient 4 while the back 27 of the patient’s head 24 is supported by the hardened heat-formable back cast material 23.
  • the heat-formable front cast material 25 is then also connected to the head brace 5 and allowed to harden after which a head immobilization cast 22 is formed comprising both a back- of-the-head cast 23 and a front-of-the-head cast 25.

Abstract

Disclosed is a head angle adjustment device (1) for use with radiation therapy equipment. The head angle adjustment device (1) comprises a board (2) having an upper support surface (3) arranged for supporting a radiation therapy patient (4), wherein a head brace (5) is protruding from a head end (6) of the board (2), and wherein an upper brace surface (7) of the head brace (5) is arranged above the upper support surface (3). The head angle adjustment device (1) further comprises a support structure (8) releasably attached to the head brace (5), wherein the support structure (8) comprises angle adjustment means (9). And the head angle adjustment device (1) comprises a head rest (10) having a first end (11) supported by the board (2) and a second end (12) supported by the angle adjustment means (9), wherein the angle adjustment means (9) are arranged to adjust an angle of the head rest (10). A method for forming a head immobilization cast (22) is also disclosed.

Description

A HEAD ANGLE ADJUSTMENT DEVICE AND A METHOD FOR FORMING A HEAD
IMMOBILIZATION CAST
Background of the invention
The invention relates to a a head angle adjustment device for use with radiation therapy equipment. The head angle adjustment device comprises a board having an upper support surface arranged for supporting a radiation therapy patient. The invention also relates to a method for forming a head immobilization cast for a radiation therapy patient by means of a head angle adjustment device.
Description of the Related Art
In relation to radiation therapy such as stereotactic radiosurgery of a patients head it is very important that the patient’s head remains in the exact same position throughout the treatment. It is therefore known to fixate the position of the patient’s head by means of one or more masks made of a thermoplastic material which is first heated to become soft and formable. The soft mask is then place and shaped on the back of the patient’s head and/or over the face of the patient after which the mask will cool down and harden to enable solid fixation of the patient’s head during radiation therapy. Such mask material has a very low radiation absorption that allow radiation therapy through the mask.
However, sometimes it is advantageous to tilt the head of the patient e.g., so that the patient’s head is moved closer to or further away from the chest, and from the international patent application WO 2005/014103 it is therefore known to place the patient on a positioning device comprising a angle adjustable head rest by means of which the patient’s head can be tilted to a desired position before a mask is formed over the patient’s face and the positioning device to fixate the patient’s head in the desired position. However, even though the head rest is made of a low-density material it will still have a relatively high radiation absorption and the positioning device takes up space around the patient’s head which may be disadvantageous in relation to the radiation therapy equipment.
From the Chinese patent application CN 112790875 A a multidirectional adjustable head fixing device is known. The device comprises a head support connected at a first end to an operating bed through a multidirectional linkage assembly and supported at another end by an adjustment rod enabling that the tilt angle of a patient’s head may be adjusted. However, even if the head support is made of a low- density material, it will still have a relatively high radiation absorption and the head support, and the adjustment rod takes up space around the patient’s head which may be disadvantageous in relation to radiation therapy equipment.
An object of the invention is therefore to provide for a better head angle adjustment technique in relation to radiation therapy fixation.
The invention
The invention provides for a head angle adjustment device for use with radiation therapy equipment. The head angle adjustment device comprises a board having an upper support surface arranged for supporting a radiation therapy patient, wherein a head brace is protruding from a head end of the board, and wherein an upper brace surface of the head brace is arranged above the upper support surface. The head angle adjustment device further comprises a support structure releasably attached to the head brace, wherein the support structure comprises angle adjustment means. The head angle adjustment device comprises a head rest having a first end supported by the board and a second end supported by the angle adjustment means, wherein the angle adjustment means are arranged to adjust a tilt angle of the head rest.
Providing the board with a head brace protruding from a head end of the board and having an upper brace surface being displaced upwards in relation to the upper support surface of the board - advantageously so that the head brace is extending around and close to the vertical middle of a supine patient’s head - is advantageous in that the entire back and front of the head of a patient - placed on the head angle adjustment device with the head in the head brace - is free and accessible for radiation therapy equipment. Furthermore, by displacing the upper brace surface upwards it is possible to form a deeper cast of the back of the patient’s head enabling better fixation by means of a back-of-the-head mask while it at the same time is possible to also form a deep cast of the front of the patient’s head.
Attaching the support structure comprising the angle adjustment means to the head brace is advantageous in that this ensures better support of the second end of the head rest so that the angle adjustment means may easily adjust the tilt angle of the head rest. And attaching the support structure releasably to the head brace is advantageous in that the support structure and the head rest hereby easily can be removed from the head brace once a head cast have been made so that the support structure and the head rest may not be in the way during subsequent radiation therapy or reduce the effect of the radiation therapy due to radiation absorption.
It should be emphasised that the term “angle adjustment means” is to be understood as any kind of angle adjuster capable of adjusting a tilt angle of the head rest of a head angle adjustment device. I.e., the term includes any kind of adjusting bolt, adjusting screw, adjustable wedge arrangement, adjustable or interchangeable spacers or other or any combination thereof which may be manually and/or automatically driven.
Furthermore, note that any reference to orientation throughout this document - i.e. up, down, over, under, top, bottom, side etc. - refers to the head angle adjustment device during normal use - i.e., where the board is placed flat on a substantially horizontal surface so that a patient may be placed laying down on the board in a supine position with the back of the head resting on the head rest and so that any vertical displacement of the head rest will cause the angle of the patient’s head to change.
In an aspect of the invention, the first end of the head rest is supported by the board at one or more board support contact points and wherein the angle adjustment means are arranged to adjust the tilt angle of the head rest by rotating the head rest around the one or more board support contact points.
Forming the equipment so that the angle adjustment means rotates the head rest around board support contact points is advantageous in that rotational displacement - i.e., tilt angle displacement - is relatively easy to design - at least compared to linear vertical displacement - and in that this entails a tilting displacement of the head rest which corresponds to the natural tilt of the head and thereby reduces discomfort of the patient using the head angle adjustment device.
In an aspect of the invention, the angle adjustment means comprises a rotatable support device arranged to support the second end of the head rest and wherein the rotatable support device comprises at least two support surfaces arranged at different distances from a rotational axis of the rotatable support device.
Forming the angle adjustment means by means of a rotatable support device comprising different support surfaces arranged at different distances from the rotational axis of the support device is advantageous in that the tilt angle of the head rest hereby easily can be adjusted in predetermined increment by rotating the support device so that the head rest is supported by a new higher or lower support surface.
In an aspect of the invention, the support structure further comprises a releasable rotation locking device arranged to lock the rotatable support device against rotation in relation to the support structure. Providing the support structure with a releasable rotation locking device is advantageous in that it hereby is possible to lock the support device against rotation in relation to the support structure in a simple and efficient manner.
In an aspect of the invention, the head angle adjustment device further comprises a support pillow placed on the head rest.
Making the head angle adjustment device comprise a support pillow placed on the head rest is advantageous in that this increases the comfort of the patient and ensures a larger contact surface which in turn will further prevent the patient from moving during the casting process.
In an aspect of the invention, the head rest comprises at least one tilt shaft or at least tilt shaft rest arranged at the first end of the head rest, wherein the board comprises the other of the at least one tilt shaft and the at least one tilt shaft rest and wherein the at least one tilt shaft is rotatably supported in the at least one tilt shaft rest.
Making the head rest comprise tilt shafts or tilt shaft rests rotatably supported in/supporting corresponding tilt shafts or tilt shaft rests of the board is advantageous in that the head rest and the tilt motion hereby is better supported and more precise.
In an aspect of the invention, the support structure is releasably attached to an underside of the head brace.
Attaching the support structure releasably to the underside of the head brace is advantageous in that this leaves the upper brace surface of the head brace free for attaching heat-formable cast material to the head brace, while it is easy to remove (and attach) the support structure without interfering with the heat-formable cast material. In an aspect of the invention, the upper brace surface of the head brace is substantially parallel with the upper support surface of the board.
Forming the upper brace surface of the head brace substantially parallel with the upper support surface of the board is advantageous in that this enables that the head cast may be formed more symmetrically and with better support no matter if the head is tilted forward, backward or maintained in a straight position during casting. Furthermore, the parallel arrangement ensures that the head brace is less in the way for radiation therapy equipment.
The invention further provides for a method for forming a head immobilization cast for a radiation therapy patient by means of a head angle adjustment device. The method comprises the steps of:
• attaching a support structure of the head angle adjustment device releasably to a head brace protruding from a head end of a board of the head angle adjustment device, wherein the board has an upper support surface arranged for supporting the radiation therapy patient, wherein the support structure comprises angle adjustment means and wherein an upper brace surface of the head brace is arranged above the upper support surface,
• placing a head rest of the head angle adjustment device so that a first end of the head rest is supported by the board and so that a second end of the head rest is supported by the angle adjustment means,
• adjusting a tilt angle of the head rest by means of the angle adjustment means,
• connecting a sheet of heat-formable back cast material to the head brace so that the heat-formable back cast material is suspended across the head brace,
• placing the radiation therapy patient on the upper support surface of the board in a supine position with the back of the patient’s head placed on the heat-formable back cast material, • deforming the heat-formable back cast material by moving the patient’s head downwards until the head rests on the head rest,
• allowing the heat-formable back cast material to harden, and
• removing the support structure and the head rest from the head brace.
Adjusting the tilt angle of the patient’s head by adjusting the tilt angle of the head rest is advantageous in that it hereby is possible to form the cast while the patient’s head is maintained in an angle that is better suited for the subsequent radiation therapy. And removing the support structure and the head rest from the head brace after the heat-formable back cast has hardened is advantageous in that the support structure and the head rest will not absorb radiation or be in the way during subsequent radiation therapy.
Note that some of the method steps can be performed in another order - i.e. the tilt angle of the head rest could be adjusted after the patient is placed on the board - either before or after the heat-formable back cast material is connected to the head brace and/or the head rest can be connected to the board before the support structure is connected to the head brace or these two steps can be performed substantially simultaneously.
In an aspect of the invention, the method further comprises the step of pressing a sheet of heat-formable front cast material down onto the face of the radiation therapy patient while the back of the patient’s head is supported by the hardened heat- formable back cast material and connecting the heat-formable front cast material to the head brace.
Forming a front-of-the-head cast while the patient’s head is resting in the back-of- the-head cast is advantageous in that this ensures better and more precise fixation of the patient’s head during the forming and hardening of the front-of-the-head cast. Furthermore, immobilizing the patient’s head by both a back-of-the-head cast and a front-of-the-head cast ensures a very strong and precise fixation of the patient’s head during subsequent radiation therapy.
In an aspect of the invention, the method further comprises placing the head rest so that so that the second end of the head rest is supported by a rotatable support device of the angle adjustment means, wherein the rotatable support device comprises at least two support surfaces arranged at different distances from a rotational axis of the rotatable support device.
Placing the head rest so that so that the second end of the head rest is supported by a rotatable support device comprising different support surfaces arranged at different distances from the rotational axis of the support device is advantageous in that the tilt angle of the head rest hereby easily can be adjusted in predetermined increment by rotating the support device so that the head rest is supported by a new higher or lower support surface.
In an aspect of the invention, the tilt angle of the head rest is adjusted by rotating the rotatable support device.
Adjusted tilt angle of the head rest by rotating the rotatable support device is a simple and efficient way of adjusting the tilt angle in fixed increments ensuring that any adjustments setting can easily and securely be reproduced.
In an aspect of the invention, the method further comprises locking the rotatable support device against rotation in relation to the support structure by means of a releasable rotation locking device before placing the radiation therapy patient with the back of the patient’s head placed on the heat-formable back cast material.
Locking the rotatable support device against rotation in relation to the support structure by means of a releasable rotation locking device is advantageous in that it hereby is possible to lock the support device against rotation in relation to the support structure in a simple and efficient manner before movements of the patient’s head could alter the position.
In an aspect of the invention, the head angle adjustment device is a head angle adjustment device according to any of the previously discussed head angle adjustment devices.
Hereby is achieved an advantageous embodiment of the invention.
Figures
The invention will be described in the following with reference to the figures in which fig. 1 illustrates a board, as seen from the top, fig. 2 illustrates a board, as seen from the side, fig. 3 illustrates a board, as seen in an isometric view, fig. 4 illustrates a head rest, as seen from the top, fig. 5 illustrates a head rest, as seen from the side, fig. 6 illustrates a head rest, as seen in an isometric view, fig. 7 illustrates a support structure, as seen from the bottom, fig. 8 illustrates a support structure, as seen from the side, fig. 9 illustrates a support structure, as seen from the end, fig. 10 illustrates a support structure, as seen in an isometric view, fig. 11 illustrates a head angle adjustment device, as seen from the top, fig. 12 illustrates a head angle adjustment device, as seen from the side, fig. 13 illustrates a head angle adjustment device, as seen in an isometric view, fig. 14 illustrates a head angle adjustment device with heat- formable back cast material, as seen from the top, fig. 15 illustrates a head angle adjustment device with heat- formable back cast material, as seen from the side, fig. 16 illustrates a patient placed on a head angle adjustment device with heat-formable back cast material, as seen from the side, and fig. 17 illustrates a patient fixated by heat-formable back cast material and heat-formable front cast material, as seen from the side. Detailed description of related art
Fig. 1 illustrates a board 2, as seen from the top, fig. 2 illustrates a board 2, as seen from the side and fig. 3 illustrates a board 2, as seen in an isometric view.
In this embodiment of the invention the board 2 has an upper support surface 3 on which a patient may be laying during casting of back and/or front casts of the patient’s head and e.g., during subsequent radiation therapy. The board 2 comprises a head brace 5 which is protruding from a head end 6 of the board 2. In this embodiment the head brace and thereby the upper brace surface 7 of the head brace 5 is vertically displaced in relation to the upper support surface 3 so that the head brace is positioned substantially at the vertical middle or at least closer to the vertical middle of the head of a patient lying on the board 2 with the head positioned in the head brace 5 as seen in figs. 16 and 17. In this embodiment the upper brace surface 7 of the head brace 5 is vertically displaced approximately 80 mm in relation to the upper support surface 3. However, in another embodiment the upper brace surface 7 of the head brace 5 could be vertically displaced less in relation to the upper support surface 3 - such as 70 mm, 60 mm, 50 mm, 40 mm or even less or the upper brace surface 7 could be vertically displaced more - such as 90 mm, 100 mm, 110 mm or even more.
In this embodiment the board 2 including the head brace 5 are integrally formed and made entirely of a low-density Carbon-fiber-reinforced polymer material that is strong and a has a very low radiation absorption. However, in another embodiment the board 2 and/or parts of the board could also or instead be made of fiberglass reinforced resin, ceramic, stainless steel or another metal, a composite material or other or any combination thereof and/or the bord 2 could be formed by more interconnected parts. Fig. 4 illustrates a head rest 10, as seen from the top, fig. 5 illustrates a head rest 10, as seen from the side and fig. 6 illustrates a head rest 10, as seen in an isometric view.
In this embodiment the head rest 10 has a first end 11 arranged to be supported by the board 2 and a second end 12 arranged to be supported by angle adjustment means 9 of a support structure 8 as disclosed in relation to figs. 11-16.
In this embodiment the head rest 10 is disclosed without a support pillow 18 but as disclosed in figs. 11-16 a support pillow 18 could in another embodiment be placed on the head rest 10. Thus, in this embodiment the head rest 10 is provided with three sets of connection holes 28 enabling that the support pillow 18 can be connected to the head rest 10 in three different positions.
Fig. 7 illustrates a support structure 8, as seen from the top, fig. 8 illustrates a support structure 8, as seen from the side, fig. 8 illustrates a support structure 8, as seen from the end and fig. 10 illustrates a support structure 8, as seen in an isometric view.
In this embodiment the support structure 8 comprises a support brace 29 having a shape substantially corresponding to the shape of the head brace 5 of the board 2. However, in another embodiment the support brace 29 could be shaped differently and different from the head brace 5 e.g., to reduce material use, to enhance functionality or other. In this embodiment the support brace 29 is arranged to be releasably attached to the head brace 5 by means of connection tracks 30 arranged to engage retainer pins 31 on the underside 21 of the head brace 5 as disclosed in figs. 12-13. However, in another embodiment the support brace 29 could also or instead be releasably attached to the head brace 5 through other means - such as a key and spline arrangement or another type of interlocking geometry that would allow the support brace 29 to easily be slid onto the head brace 5, or the support brace 29 could also or instead be releasably attached to the head brace 5 through thumbscrews, bolt or screws, a quick-lock or snap-lock arrangement or any other type of connection arrangement that would allow the support brace 29 to be releasably attached to the head brace 5.
In this embodiment the support structure 8 comprises a support bridge 32 bridging the underside of the support brace 29 and the support structure 8 comprises angle adjustment means 9 which in this embodiment are arranged to extend across the support bridge 32.
In this embodiment the angle adjustment means 9 comprise a rotatable support device 14 arranged to support the second end 12 of the head rest 10 as disclosed in relation to figs. 11-16. In this embodiment the rotatable support device 14 comprises six support surfaces 15 arranged at different distances from the rotational axis 16 of the support device 14 so that the second end 12 of the head rest 10 can be vertically supported at six different heights depending on the rotational orientation of the support device 14 so that in this embodiment the angle adjustment means 9 are arranged adjust the tilt angle A of the head rest 10 between six different tilt angles - i.e., in this embodiment the support device 14 is formed as a polygonal eccentric. However, in another embodiment the support device 14 could comprise more different support surfaces 15 - such as eight, ten, thirteen or even more - or the support device 14 could comprise fewer different support surfaces 15 - such as five, three or even one if the support device 14 was formed as a smooth eccentric.
In another embodiment the angle adjustment means 9 could also or instead be enabled by a support spindle (not shown) engaging a threaded through hole in the support bridge 32 so that the spindle could be rotated to vertically displace the second end 12 of the head rest 10, the angle adjustment means 9 could also or instead be enabled by means of a wedge (not shown) arranged between the support bridge 32 and the second end 12 of the head rest 10 so that the wedge could be linearly displaced to vertically displace the second end 12 of the head rest 10 and/or the angle adjustment means 9 could be enabled in numerous other ways known to the skilled person.
In this embodiment the support structure 8 also comprises a releasable rotation locking device 17 arranged to lock the support device 14 against rotation in relation to the support structure 8. In this embodiment the locking device 17 comprises a linearly displaceable spring-biased locking pin 33 extending through a hole in the support bridge 32 to engage the support device 14 so that when the locking pin 33 is manually pulled out of engagement with the support device 14, the support device 14 can be freely rotated. However, in another embodiment the locking device 17 could be formed in numerous other ways - such as by means of a locking screw, by means of a spring-biased locking ball arranged on the support bridge 32 to engage corresponding locking indentations on the support device 14 or other or any combination thereof.
In this embodiment the support device 14 is further provided with a position disc 34 comprising visual indication of the tilt angle A when the support device 14 is rotated to any given position, making it easier to detect the actual tilt angle, to document settings, instruct personnel and other.
In this embodiment the support structure 8 is further provided with handles 35 to enable easier attachment and dismounting of the support structure 8 on and from the head brace 5.
In this embodiment the head rest 10 and the support structure 8 are predominantly made of a low-density Carbon-fiber-reinforced polymer material that is strong and has a very low radiation absorption. However, since the head rest 10 and the support structure 8 are typically removed before radiation therapy the head rest 10 and/or the support structure 8 could in another embodiment also or instead be made of fiberglass reinforced resin, ceramic, stainless steel or another metal, a composite material or other or any combination thereof.
Fig. 11 illustrates a head angle adjustment device 1, as seen from the top, fig. 12 illustrates a head angle adjustment device 1, as seen from the side and fig. 13 illustrates a head angle adjustment device 1, as seen in an isometric view.
In this embodiment the first end 11 of the head rest 10 is supported by the board 2 at board support contact points 13 in the form of tilt shafts 19 protruding from the first end 11 of the head rest 10 and engaging corresponding tilt shaft rests 20 on the board 2 so that the head rest 10 may rotate in relation to the board 2 without being linearly displaced in any horizontal direction. The tilt shaft rests 20 are open at the top, so that the head rest 10 may easily be connected to or released from the board 2. However, in another embodiment the tilt shafts 19 could be arranged on the board 2 and the tilt shaft rests 20 could be arranged on the head rest 10. Or in another embodiment the first end 11 of the head rest 10 and the board 2 could be provided with other forms of protrusions engaging other forms of indentions or grooves to ensure that the head rest 10 may rotate in relation to the board 2 without being linearly displaced in any horizontal direction.
In this embodiment the first end 11 of the head rest 10 is first attached to the board 2 after which the support structure 8 is attached to the head brace 5 by an operator sliding the support structure 8 in under the head brace 5 so that the connection tracks 30 of the support structure 8 engages the retainer pins 31 on the underside 21 of the head brace 5 and so that the second end 12 of the head rest 10 is supported by the angle adjustment means 9 of the support structure 8. However, in another embodiment the connection tracks 30 could be formed on the head brace 5 and the retainer pins 31 could be arranged on a topside of the support structure 8. Also, in another embodiment the support structure 8 could be connected to the head brace 5 first after which the head rest 10 is mounted, or the support structure 8 and the head rest 10 could be formed as a single unit that could be mounted in a single operation. After use the support structure 8 and the head rest 10 would be removed in a similar fashion by revering the mounting steps.
In this embodiment the head rest 10 is provided with a support pillow 18 to increase the comfort of the user and in this embodiment the angle adjustment means 9 is adjusted so that the head rest 10 is substantially flush with the upper support surface 3 of the board 2 forming a tilt angle A of approximately 0°. However, by means of the angle adjustment means 9 the tilt angle A of the head rest 10 can in this embodiment be adjusted to -2.5°, -5°, -7.5°, +3° and +6° in relation to the current position of 0°. However, in another embodiment the angle adjustment means 9 could obviously be arranged to tilt the head rest 10 to different tilt angles A - such as -1°, - 6°, -10° or even more, and/or +1°, +4.5°, +11° or even more. Or the angle adjustment means 9 could be arranged to adjust the tilt angle A stepless within a range of -30° to +30°, within a range of -20° to +20°, within a range of -18° to +12° or within another rage.
Fig. 14 illustrates a head angle adjustment device 1 with heat-formable back cast material 23, as seen from the top and fig. 15 illustrates a head angle adjustment device 1 with heat-formable back cast material 23, as seen from the side. Fig. 16 illustrates a patient 4 placed on a head angle adjustment device 1 with heat-formable back cast material 23, as seen from the side and fig. 17 illustrates a patient 4 fixated by heat-formable back cast material 23 and heat-formable front cast material 25, as seen from the side.
In this embodiment the head angle adjustment device 1 is used for forming a head immobilization cast 22 for a radiation therapy patient 4 by first connecting the head rest 10 to the board 2 after which the support structure 8 is releasably attached to the head brace 5 so that the first end 11 of the head rest 10 is supported by the board 2 and the second end 12 of the head rest 10 is supported the angle adjustment means 9 of the support structure 8. A radiation therapy patient 4 is then placed on the upper support surface 3 of the board 2 in a supine position with the patient’s head 24 placed in the head brace 5 and with the back 27 of the patient’s head 24 placed on the head rest 10 after which the tilt angle A of the head rest 10 is adjusted by means of the angle adjustment means 9 to position the patient’s head 24 in an desired angle in relation to the subsequent stereotactic radiosurgery. After this the patient’s head 24 is removed from the head brace 5 and the head rest 10, and a sheet of soft and formable heat-formable back cast material 23 is attached to the upper side of the head brace 5 so that the heat-formable back cast material 23 is suspended across the head brace 5 as disclosed in figs. 14 and 15. After this the patient 4 is again placed on the upper support surface 3 of the board 2 in a supine position with the back 27 of the patient’s head 24 placed on the heat-formable back cast material 23 and the heat-formable back cast material 23 is deformed by moving the patient’s head 24 downwards until the head 24 rests on the head rest 10 again. After this the heat-formable back cast material 23 is allowed to harden over a period of time after which the support structure 8 and the head rest 10 is removed from the head brace 5 and the patient’s head 24 is fixed in and supported by the hardened back cast material 23 and ready for radiation therapy. However, in another embodiment the heat-formable back cast material 23 could be attached to the head brace 5 right after the support structure 8 and the head rest 10 was attached to the board 2, and the tilt angle A of the head rest 10 would be adjusted by means of the angle adjustment means 9 after the heat- formable back cast material 23 is deformed by moving the patient’s head 24 downwards until the head 24 rests on the head rest 10.
If further fixation of the patient’s head is needed the procedure could further include pressing a sheet of heat-formable front cast material 25 down onto the front i.e., the face 26 of the radiation therapy patient 4 while the back 27 of the patient’s head 24 is supported by the hardened heat-formable back cast material 23. The heat-formable front cast material 25 is then also connected to the head brace 5 and allowed to harden after which a head immobilization cast 22 is formed comprising both a back- of-the-head cast 23 and a front-of-the-head cast 25.
The invention has been exemplified above with reference to specific examples of boards 2, support structures 8, head rests 10 and other. However, it should be understood that the invention is not limited to the particular examples described above but may be designed and altered in a multitude of varieties within the scope of the invention as specified in the claims.
List
1. Head angle adjustment device
2. Board
3. Upper support surface of board
4. Patient
5. Head brace
6. Head end of board
7. Upper brace surface
8. Support structure
9. Angle adjustment means
10. Head rest
11. First end of head rest
12. Second end of head rest
13. Board support contact point
14. Rotatable support device
15. Support surface
16. Rotational axis of support device
17. Rotation locking device
18. Support pillow
19. Tilt shaft
20. Tilt shaft rest
21. Underside of head brace
22. Head immobilization cast
23. Heat-formable back cast material
24. Patient’s head
25. Heat-formable front cast material
26. Face of patient’s head
27. Back of patient’s head
28. Connection holes
29. Support brace 30. Connection track
31. Retainer pin
32. Support bridge
33. Locking pin 34. Position disc
35. Handle
A. Tilt angle

Claims

Claims
1. A head angle adjustment device (1) for use with radiation therapy equipment, said head angle adjustment device (1) comprising
• a board (2) having an upper support surface (3) arranged for supporting a radiation therapy patient (4), wherein a head brace (5) is protruding from a head end (6) of said board (2), and wherein an upper brace surface (7) of said head brace (5) is arranged above said upper support surface (3),
• a support structure (8) releasably attached to said head brace (5), wherein said support structure (8) comprises angle adjustment means (9), and
• a head rest (10) having a first end (11) supported by said board (2) and a second end (12) supported by said angle adjustment means (9), wherein said angle adjustment means (9) are arranged to adjust a tilt angle (A) of said head rest (10).
2. A head angle adjustment device (1) according to claim 1, wherein said first end (11) of said head rest (10) is supported by said board (2) at one or more board support contact points (13) and wherein said angle adjustment means (9) are arranged to adjust the tilt angle (A) of said head rest (10) by rotating said head rest (10) around said one or more board support contact points (13).
3. A head angle adjustment device (1) according to claim 1 or 2, wherein said angle adjustment means (9) comprises a rotatable support device (14) arranged to support said second end (12) of said head rest (10) and wherein said rotatable support device (14) comprises at least two support surfaces (15) arranged at different distances from a rotational axis (16) of said rotatable support device (14).
4. A head angle adjustment device (1) according to claim 3, wherein said support structure (8) further comprises a releasable rotation locking device (17) arranged to lock said rotatable support device (14) against rotation in relation to said support structure (8).
5. A head angle adjustment device (1) according to any of the preceding claims, wherein said head angle adjustment device (1) further comprises a support pillow (18) placed on said head rest (10).
6. A head angle adjustment device (1) according to any of the preceding claims, wherein said head rest (10) comprises at least one tilt shaft (19) or at least one tilt shaft rest (20) arranged at said first end (11) of said head rest (10), wherein said board (2) comprises the other of said at least one tilt shaft (19) and said at least one tilt shaft rest (20) and wherein said at least one tilt shaft (19) is rotatably supported in said at least one tilt shaft rest (20).
7. A head angle adjustment device (1) according to any of the preceding claims, wherein said support structure (8) is releasably attached to an underside (21) of said head brace (5).
8. A head angle adjustment device (1) according to any of the preceding claims, wherein said upper brace surface (7) of said head brace (5) is substantially parallel with said upper support surface (3) of said board (2).
9. A method for forming a head immobilization cast (22) for a radiation therapy patient (4) by means of a head angle adjustment device (1), said method comprising the steps of:
• attaching a support structure (8) of said head angle adjustment device (1) releasably to a head brace (5) protruding from a head end (6) of a board (2) of said head angle adjustment device (1), wherein said board (2) has an upper support surface (3) arranged for supporting said radiation therapy patient (4), wherein said support structure (8) comprises angle adjustment means (9) and wherein an upper brace surface (7) of said head brace (5) is arranged above said upper support surface (3), • placing a head rest (10) of said head angle adjustment device (1) so that a first end (11) of said head rest (10) is supported by said board (2) and so that a second end (12) of said head rest (10) is supported by said angle adjustment means (9),
• adjusting a tilt angle (A) of said head rest (10) by means of said angle adjustment means (9),
• connecting a sheet of heat-formable back cast material (23) to said head brace (5) so that said heat-formable back cast material (23) is suspended across said head brace (5),
• placing said radiation therapy patient (4) on said upper support surface (3) of said board (2) in a supine position with the back (27) of said patient’s head (24) placed on said heat-formable back cast material (23),
• deforming said heat-formable back cast material (23) by moving said patient’s head (24) downwards until said head (24) rests on said head rest (10),
• allowing said heat-formable back cast material (23) to harden, and
• removing said support structure (8) and said head rest (10) from said head brace (5).
10. A method according to claim 9, wherein said method further comprises the step of pressing a sheet of heat-formable front cast material (25) down onto the face (26) of said radiation therapy patient (4) while said back (27) of said patient’s head (24) is supported by said hardened heat-formable back cast material (23) and connecting said heat-formable front cast material (25) to said head brace (5).
11. A method according to claim 9 or 10, wherein said method further comprises placing said head rest (10) so that so that said second end (12) of said head rest (10) is supported by a rotatable support device (14) of said angle adjustment means (9), wherein said rotatable support device (14) comprises at least two support surfaces (15) arranged at different distances from a rotational axis (16) of said rotatable support device (14).
12. A method according to claim 11, wherein said tilt angle (A) of said head rest (10) is adjusted by rotating said rotatable support device (14).
13. A method according to claim 11 or 12, wherein said method further comprises locking said rotatable support device (14) against rotation in relation to said support structure (8) by means of a releasable rotation locking device (17) before placing said radiation therapy patient (4) with the back (27) of said patient’s head (24) placed on said heat-formable back cast material (23).
14. A method according to any of claims 9 to 13, wherein said head angle adjustment device (1) is a head angle adjustment device (1) according to any of claims 1-8.
PCT/DK2023/050100 2022-05-06 2023-04-25 A head angle adjustment device and a method for forming a head immobilization cast WO2023213365A1 (en)

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