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WO2025231381A1 - Système et procédé de positionnement reproductible d'un patient soumis à des procédures de radiothérapie - Google Patents

Système et procédé de positionnement reproductible d'un patient soumis à des procédures de radiothérapie

Info

Publication number
WO2025231381A1
WO2025231381A1 PCT/US2025/027526 US2025027526W WO2025231381A1 WO 2025231381 A1 WO2025231381 A1 WO 2025231381A1 US 2025027526 W US2025027526 W US 2025027526W WO 2025231381 A1 WO2025231381 A1 WO 2025231381A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
support
region
head
immobilizer
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2025/027526
Other languages
English (en)
Inventor
David Rabeno
Andrew Johnson
Melissa REID
Hannah MIKKELSEN
Kenne ZONY
Sean MCGRENAGHAN
Lindsay MAO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
QFix Systems LLC
Original Assignee
QFix Systems LLC
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 QFix Systems LLC filed Critical QFix Systems LLC
Publication of WO2025231381A1 publication Critical patent/WO2025231381A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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 or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis 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
    • 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 present invention relates generally to an apparatus, a system, and methods for immobilizing a patient's anatomy, and more specifically to immobilizing the patient's anatomy for radiotherapy procedures, including using electrons, photons, protons, and heavy ions.
  • an immobilization apparatus may be provided to facilitate such repeatability.
  • the patient may additionally be positioned such that desirable imaging and treatment angles are not obstructed . This is especially important where critical structures such as the brain, spinal cord, and optic nerves are potentially impacted. Even small obstructions in the field of treatment can render certain angles unavailable to the clinician. As such, it is desirable to create access to a wide range of imaging and treatment angles while maintaining highly accurate and repeatable positioning of the patient.
  • the present invention is directed to an apparatus, a system, and methods of use of the apparatus and system for immobilizing a patient's anatomy for radiotherapy procedures, including using electrons, photons, protons, and heavy ions.
  • an apparatus for positioning and immobilizing a patient undergoing radiotherapy procedures includes a patient support configured to support a patient, an immobilizer configured to restrain the patient's anatomy, and releasable locks.
  • the patient support has a body support region configured to support at least a portion of a body of a patient inferior to the shoulders and a head support region configured to support the head and neck of a patient.
  • the immobilizer is configured to restrain the patient's anatomy, and has at least one frame coupled to at least one formable sheet comprised of low-melting temperature thermoplastic material, which is formable at a first, elevated temperature and rigid at a second, lower temperature.
  • At least a portion of the at least one frame remains substantially perpendicular to a ray extending to a region of interest when coupled to the patient support, thereby creating a continuous transition area and minimizing impacts to imaging and treatment delivery.
  • the releasable locks are coupled to the at least one frame of the immobilizer and are configured to be received by corresponding openings disposed on the head support region of the patient support.
  • the releasable locks are further configured to couple the immobilizer to the head support region of the patient support.
  • the head support region of the patient support is configured such that obstructions to imaging or treatment delivery are minimized and further wherein the releasable locks are positioned such that they do not interfere with imaging or treatment delivery.
  • a system for positioning and immobilizing a patient undergoing radiotherapy procedures includes a patient support configured to support a patient, an immobilizer configured to restrain the patient's anatomy, releasable locks, and a posterior support configured to support the neck of the patient.
  • the patient support has a body support region configured to support at least a portion of a body of a patient inferior to the shoulders and a head support region configured to support the head and neck of a patient.
  • the immobilizer is configured to restrain the patient's anatomy, and has at least one frame coupled to at least one formable sheet comprised of low- melting temperature thermoplastic material, which is formable at a first, elevated temperature and rigid at a second, lower temperature.
  • At least a portion of the at least one frame remains substantially perpendicular to a ray extending to a region of interest when coupled to the patient support, thereby creating a continuous transition area and minimizing impacts to imaging and treatment delivery.
  • the releasable locks are coupled to the at least one frame of the immobilizer and are configured to be received by corresponding openings disposed on the head support region of the patient support.
  • the releasable locks are further configured to couple the immobilizer to the head support region of the patient support.
  • the head support region of the patient support is configured such that obstructions to imaging or treatment delivery are minimized and further wherein the releasable locks are positioned such that it does not interfere with imaging or treatment delivery.
  • a method for creating a customized system configured to position and immobilize a patient undergoing radiotherapy procedures includes the following steps without being limited to any particular order: (a) Placing a patient support on a target modality; (b) Positioning a patient on a patient support; (c) Selecting an appropriate at least one indexer; (d) Activating a posterior support; (e) Placing the posterior support such that it is positioned proximal to the patient's neck on the patient support and on the indexer; (f) Positioning the patient on the patient support such that the patient's head and neck are received by the head support region of the patient support and a formable support cushion; (g) Forming the posterior support to the patient's anatomy; (h) Allowing the posterior support to become rigid; (i) Heating an immobilizer to a first, elevated temperature; (j) Attaching the immobilizer to the head support region; (k) Forming the immobilizer to the patient's anatomical contours; and (I)
  • a method for positioning a patient utilizing a customized system configured to position and immobilize a patient undergoing radiotherapy procedures comprises the following without limitation to any particular order: (a) Placing a patient support on a target modality; (b) Selecting an appropriate at least one indexer; (c) Placing posterior support such that an indexing feature on underside of posterior support mates with the at least one indexer; (d) Positioning the patient on the patient support such that the head of the patient is received within the patient support; (e) Placing a formed immobilizer over the patient's anatomy; and (f) Attaching a formed immobilizer such that it immobilizes the patient.
  • a kit for positioning and immobilizing a patient undergoing radiotherapy procedures.
  • the kit can include a patient support having a body support region configured to support at least a portion of the patient and a head support region configured to support the head and neck of the patient, the head support region of the patient support having mounting apertures to which other components of the kit can be attached; a cushion shaping support configured to be removably attached at the mounting apertures of the head support region of the patient support for shaping a cushion to an anatomy of the patient; and a thermoplastic mask configured to be removably attached at the mounting apertures of the head support region of the patient support for immobilizing the anatomy of the patient.
  • a system for positioning and immobilizing a patient undergoing radiotherapy procedures.
  • the system can include a patient support having a body support region configured to support at least a portion of the patient and a head support region configured to support the head and neck of the patient, the head support region of the patient support having mounting apertures to which other components of the kit can be attached; a cushion shaping support configured to be removably attached at the mounting apertures of the head support region of the patient support for shaping a cushion to an anatomy of the patient; and a thermoplastic mask configured to be removably attached at the mounting apertures of the head support region of the patient support for immobilizing the anatomy of the patient; wherein the cushion shaping support is attached at the mounting apertures of the head support region of the patient support when the cushion is shaped to an anatomy of the patient; and wherein the thermoplastic mask is attached at the mounting apertures of the head support region of the patient support when the anatomy of the patient is immobilized upon removal of the cushion shaping support.
  • FIGURES 1A-1D illustrate an apparatus and a system for positioning and immobilizing a patient undergoing radiotherapy procedures according to embodiments of the invention.
  • FIGURES 2A-2D illustrates the apparatus of FIGURES 1A-1D coupled to an imaging table according to an embodiment of the invention.
  • FIGURE 3 illustrates different orientations of a patient support of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURE 4A illustrates different orientations of an immobilizer of the apparatus of FIGURES 1A-1D connected to a head and shoulder thermoplastic mask according to an embodiment of the invention.
  • FIGURE 4B illustrates different orientations of an immobilizer of the apparatus of FIGURES 1A-1D connected to a head-only thermoplastic mask according to an embodiment of the invention.
  • FIGURE 4C illustrates different orientations of an immobilizer of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURE 4D illustrates details of an interface between the immobilizer and the patient support of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURE 5A illustrates details of a neck support of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURE 5B illustrates details of a head cushion of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURE 5C illustrates different orientations of an indexer of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURE 6A illustrates details of a thermoplastic mask of the apparatus of FIGURES 1A- 1D according to an embodiment of the invention.
  • FIGURE 6B illustrates details of a thermoplastic mask of the apparatus of FIGURES 1A- 1D according to an embodiment of the invention.
  • FIGURE 6C illustrates a head-only thermoplastic mask of the apparatus of FIGURES 1A- 1D before and after molding according to an embodiment of the invention.
  • FIGURE 6D illustrates head-only and head and shoulder thermoplastic masks of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURE 6E illustrates head and shoulder thermoplastic masks of the apparatus of FIGURES 1A-1D before and after molding according to an embodiment of the invention.
  • FIGURE 7 illustrates different orientations of forming aids for a posterior support that can be used with the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURE 8A illustrates different orientations and configurations of shoulder adapters of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURE 8B illustrates options for shoulder mask attachment points of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURES 9A-9D illustrate device configurations of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • FIGURE 10 illustrates device geometry and size of the apparatus of FIGURES 1A-1D according to an embodiment of the invention.
  • treatments for cancers and other similar radiotherapy procedures occur over a series of treatments (called fractions) which may span several weeks or months. This introduces the potential for change in the patient's anatomy over time. Such changes may be due to normal fluctuations in a patient's physical well-being or may result from the radiotherapy treatment or adjuvant treatments for their underlying condition. For example, patients may lose weight due to side effects of chemotherapy and radiotherapy. Alternately, they may gain weight as a side effect of steroids to provide relief from side effects from their other treatments or to reduce inflammation.
  • Embodiments of this invention can have the capability to adjust the fit of an immobilization device while maintaining desirable dosimetric properties and enabling a wide range of homogeneous, unobstructed angles for delivery of imaging and treatment procedures.
  • the present invention aims to solve this issue according to selected embodiments, offering clearly visible docking locations and an intuitive thermoplastic mask pin system to ensure intuitive and effortless use, resulting in a more efficient setup and treatment process.
  • the apparatus and system as described above result in a device having a conformal design combined with customizable patient positioning options, which optimizes the proton beam penumbra and maximizes treatment angles to achieve improved outcomes.
  • an apparatus 100 for positioning and immobilizing a patient undergoing radiotherapy procedures comprises a patient support 102 configured to support a patient, an immobilizer 104 configured to restrain the patient's anatomy, and releasable locks 108 configured to couple the immobilizer 104 to the patient support 102.
  • the patient support 102 is coupled to an underlying support structure 204 such as an imaging table or treatment couch top, for example.
  • the patient support 102 may have features designed to receive locating features common in the industry disposed on the underlying support structure 204 (shown in FIGURE 2B), such as the non-limiting example of a locating bar with one or more pins 902a-902d (shown in FIGURE 9C).
  • the patient support 102 may be connectable into the structure of the underlying support structure 204 and extend a surface formed by said underlying support structure 204, for example, as an interchangeable couch top insert.
  • the patient support 102 may be configured such that it provides a tapered transition to the structure of the underlying support structure 204 (shown in FIGURE 1C).
  • the edges of the patient support 102 may include side-notches 306 (shown in FIGURE ID), which may allow for the attachment of hand grips 112 (shown in FIGURE 2B) or other accessories.
  • the patient support 102 may include a plurality of holes, such as openings 110, holes 308, holes 310, and holes 802.
  • the openings 110 may be head mask mounting holes.
  • the holes 308 may be shoulder mask mounting holes.
  • the holes 310a may be neck support mounting holes and the holes 310b may be a cranial flap mounting hole.
  • the holes 802 may be shoulder adapter mounting holes (as described below in reference to FIGURE 8A).
  • the apparatus 100 may be configured to connect to hand grips 112 (shown in FIGURE 2B).
  • the hand grips 112 are configured for quick attachment to and removal from the patient support 102 of the apparatus 100.
  • the patient support 102 may be provided with an indexing scale with 5mm increments for attaching the hand grips 112 to accommodate different patient sizes.
  • the patient support 102 has a body support region 302 (shown in FIGURE 3) configured to support at least a portion of a body of a patient.
  • the body support region 302 supports at least the patient's shoulders and upper back.
  • the body support region 302 extends inferiorly and supports at least the remaining portion of the patient's back.
  • the body support region 302 may further include features adapted to receive various accessories to support positioning of the patient, for example, side-notches 306, holes 308, or other such features (as further described above in reference to FIGURE 1).
  • the body support region 302 may include features that enable attachment of such positioning accessories continuously along the length of the body support region 302.
  • the patient support 102 additionally has a head support region 304 configured to support the head and neck of the patient.
  • the head support region 304 is configured such that obstructions to imaging or treatment delivery are minimized.
  • the head support region 304 is configured to be substantially narrower than the body support region 302 and is further configured to support a narrow region defined by the occiput of the patient and back of their neck. This enables the amount of material to be minimized within the head region, thereby improving homogeneity and reducing potential for transitions which may impact imaging or treatment.
  • the head support region 304 may further include holes 310a and 310b (as further described above in reference to FIGURE 1).
  • the apparatus 100 includes an immobilizer 104 configured to restrain the patient's anatomy.
  • the immobilizer 104 has at least one frame 106 coupled to at least one thermoplastic sheet 602 (shown in FIGURE 6E) of formable material.
  • the formable material is a low-melting temperature thermoplastic material.
  • the formable material may be 3.2mm thick thermoplastic material.
  • a non-limiting example of such material known to one having ordinary skill in the art includes polyester-based thermoplastics with or without additional fillers or additives (such as polycaprolactone thermoplastics).
  • the formable sheet 602 is formable at a first, elevated temperature and becomes rigid at a second, lower temperature.
  • the at least one frame 106 of the immobilizer 104 is composed of a material that remains substantially rigid at both temperatures and provides a means for the clinician to manipulate the immobilizer 104 to form it to the patient's anatomy and couple the immobilizer 104 to the patient support 102.
  • the apparatus 100 is composed of materials which minimize attenuation of an x-ray beam.
  • at least the head support region 304 of the patient support 102 is constructed such that it is homogeneous to x-rays.
  • the patient support 102 is constructed such that it is homogeneous to x-rays in both the head support region 304 and the body support region 302.
  • the at least one frame 106 of the immobilizer 104 (shown in FIGURE 4C) is further provided with releasable locks 108, and the head support region 304 of the patient support 102 further has openings 110 corresponding to the releasable locks 108.
  • the openings 110 are configured to receive the releasable locks 108 to removably attach the immobilizer 104 to the head support region 304 of the patient support 102.
  • the releasable locks 108 may include various styles of fasteners, such as clips, pins, plungers, interference locks, pin-and-finger arrangements, swivel locks, and others known to one having ordinary skill in the art.
  • At least three releasable locks 108 and corresponding openings 110 are provided.
  • the releasable locks 108 are positioned such that at least one of the releasable locks 108 is disposed either at or superior to the vertex of the patient's skull and another at least one of the releasable locks 108 is positioned proximal to the junction of the patient's neck and shoulders.
  • At least four releasable locks 108 and corresponding openings 110 are provided and are further positioned such that at least two of the releasable locks 108 are disposed at or superior to the vertex of the patient's skull, on opposing sides of the patient's anatomy, and another at least two of the releasable locks 108 are disposed proximal to the junction of the patient's neck and shoulders, on opposing sides of the patient's anatomy.
  • the interface 402 (shown in FIGURE 4D) between the at least one frame 106 of the immobilizer 104, the releasable locks 108, and the head support region 304 of the patient support 102 are arranged in such a way that the structures do not interfere with imaging or treatment delivery, including proton therapy or heavy ion therapy.
  • the materials for the apparatus's components in at least the head support region 304 of the patient support 102 and the immobilizer 104 are preferably selected to minimize attenuation of x-ray beams. This can be important for kilovolt and megavolt x-ray imaging and treatment.
  • the geometry of the apparatus 100 and its components may be further configured such that inhomogeneities are minimized, especially within a region of interest.
  • the region of interest is a region defined by at least the patient's brain. In certain embodiments, the region of interest may be further expanded to include the patient's spinal column. Such an embodiment implements homogeneity in the head support region 304 and/or a portion of the body support region 302.
  • the at least one frame 106 of the immobilizer 104 and the releasable locks 108 are also configured to minimize inhomogeneities and other inconsistencies in the region of interest.
  • the releasable locks 108 are positioned superiorly and inferiorly to the desired field of imaging or treatment.
  • the releasable locks 108 are substantially perpendicular to the thermoplastic mask 602, but since these locks are located outside of the region of interest, the immobilizer 104 in the region of interest is a blade not an angle. This prevents any material from being along the line of the beam. Further, the releasable locks 108 are not positioned within a path or ray extending to a focal point within the region of interest (such as a tumor or isocenter of a treatment or imaging machine). In practical application, this focal point may be a volume located within the region of interest and may be regular or irregular in shape.
  • At least one path or ray extending to this focal point are not obstructed and remain substantially perpendicular to the structures of the apparatus 100 along a linear distance where the immobilizer 104 meets an edge of the head support region 304 defined at its upper and lower bounds by the releasable locks 108.
  • at least a portion of the at least one frame 106 defined along this linear distance is configured such that it adjoins the edge of the head support region 304 in a manner that extends a curve or edge of the head support region 304 and remains substantially perpendicular to a path or ray extending to the focal point.
  • the releasable locks 108 are substantially perpendicular to the thermoplastic mask 602, but since the releasable locks 108 are located outside of the region of interest, the immobilizer 104 in the region of interest is a blade not an angle. This prevents any material from being along the line of the beam.
  • At least one shim 604 is provided in association with the immobilizer 104.
  • the shim 604 is configured to adjust a distance between the at least one frame 106 of the immobilizer 104 and the patient support 102.
  • the at least one shim 604 may be one or more separately provided pieces designed to be interposed between the at least one frame 106 and the patient support 102.
  • the plural shims 604 may be stacked to achieve the desired adjustment.
  • Plural shims 604 may be co located with the releasable locks 108 and individually interposed between the releasable locks 108 at each releasable lock 108 and the patient support 102, thereby achieving individual adjustability at each releasable lock 108 in discrete increments.
  • the at least one shim 604 may be integrated into the apparatus 100, e.g. utilizing integrated shims. Such integrated shims offer instant setup feedback and precise control to enable the adjustment of the mask's in critical areas.
  • Each of the at least one integrated shims 604 may be adapted to adjust in discrete 0.5mm increments, with a total range of 4mm. The 4mm range of height adjustment in discrete 0.5 mm increments may allow for optimized immobilization. Other height adjustments, including other height ranges and increments, can be made for a more customized solution.
  • One or more shim pins can be provided. The attachment location of such an integrated shim pin may be strategically located outside of treatment paths, e.g. located superior of the top of a patient's head and/or located clear of posterior oblique treatment angles of 160°/200°.
  • the at least one shim 604 may be integrated into the structure of at least one of the at least one frame 106 of the immobilizer 104 or the patient support 102 without separable pieces. In a further preferred embodiment, the at least one shim 604 is co-located and may further be integrated with the structure of the releasable locks 108. In this embodiment, the at least one shim 604 is adapted to adjust a range of discrete distances between the patient support 102 and the at least one frame 106 at each individual releasable lock 108.
  • the at least a portion of the at least one frame 106 is configured such that the transition area between this portion of the at least one frame 106 and the patient support 102 remains substantially continuous at the adjustment points within the range of discrete distances. This enables adjustability of the immobilizer 104, ensuring appropriate fit and patient positioning throughout the course of treatment while preserving the relevant dosimetric and structural properties that make the apparatus 100 ideal for applications where homogeneity and smooth transitions are required, such as heavy ion therapy and proton therapy.
  • a system 150 (shown in FIGURES 1A-1D) including the above-described apparatus 100 is described.
  • the system 150 further includes additional components configured to support the patient and increase reproducibility of the set up.
  • the additional components further position the patient in such a manner that the region of interest is vertically disposed relative the interface of the immobilizer 104 with the patient support 102, thereby supplementing the availability of certain imaging and treatment angles.
  • the system 150 additionally includes a posterior support 502 (shown in FIGURE 5A and FIGURE 5B), such as a formable cushion, for example, configured to support the neck of the patient.
  • the posterior support 502 is capable of being formed to a patient's anatomy.
  • the posterior support 502 may be a cushion, another sheet of formable thermoplastic material, a sling made of a stretchy or otherwise flexible material, or other such item known to one having ordinary skill in the art.
  • the formable nature of the posterior support 502 is activated by at least one of the following: the introduction of water or heat, the inflation of the cushion with a fluid such as air, or the evacuation of a fluid.
  • the posterior support 502 is a cushion which is formed to the patient's anatomy, which has a first pliable state and a second substantially rigid state. Activating the cushion enables the forming of the cushion to the desired anatomy, at which point it may be transitioned as appropriate to the rigid, formed state.
  • the system 150 may further comprise at least one indexer 114 capable of indexing the posterior support 502 to a region of the patient support 102.
  • the indexer 114 may also be referred to as a neck support.
  • this region of the patient support 102 is generally situated at the junction of the head support region 304 and the body support region 302 of the patient support 102, or, in other terms, the junction of the patient's shoulders and neck.
  • the indexer 114 may further assist in providing comfortable positioning by following the contour of the patient's neck and facilitating the contour of the posterior support 502 to the patient's neck.
  • plural indexers 114 may be included with the system 150 such that a clinician may select the appropriate indexer 114 to achieve appropriate positioning or comfort for a wide range of patient anatomies.
  • the indexer 114 may additionally serve to form an indexing feature in an aspect of the posterior support 502, which will assist in reproducibility of the resulting setup. In an embodiment, this indexing feature is disposed on an inferior aspect or the underside of the posterior support 502.
  • the indexer 114 may be composed of a thin plastic shell, which is for example about 1.5mm thick in one embodiment.
  • the indexer 114 may be reusable.
  • Each of the interchangeable indexers 114 may have a different height to accommodate different patient sizes/anatomy. For example, there may be provided three indexers 114 with heights of 40mm (indexer 114a), 50mm (indexer 114b) and 65mm (indexer 114c). Providing multiple options for an indexer enhances patient positioning and improves cushion indexing for better overall comfort and accuracy.
  • the posterior support 502 is substantially contained within a boundary formed by the immobilizer 104, and additionally maintains the substantially continuous transition area of the apparatus 100. This may be optionally facilitated by at least one forming aid 702 (shown in FIGURE 5B and FIGURE 7) which may be included with the system 150.
  • the at least one forming aid 702 ensures a consistent structure of the posterior support 502 which minimizes inhomogeneities such as bulges or wrinkles by providing a smooth guide extending from the edge of the head support region 304 of the patient support 102.
  • the at least one forming aid 702 is configured to be removably attached to the patient support 102 with releasable locks 108 disposed on the forming aid 702 and configured to be receivable by the corresponding openings 110 in the patient support 102, which assists in retaining the posterior support 502 in position while it transitions from the first soft and pliable state to the second, rigid state, at which point it retains the shape of the patient's anatomy and the shape of the forming aid 702.
  • the at least one forming aid 702 may help form customizable head cushions during simulation and are configured such that minimal forming is required by a therapist.
  • the at least one forming aid 702 creates a smooth, consistent outer surface and ensures no interference when installing mask frame.
  • the at least one forming aid 702 may be reusable.
  • the at least one forming aid 702 allows for the consistent and precise creation of customizable head cushions, resulting in improved treatment planning.
  • apparatus 100 can include one set of locator holes 802 in the shoulder area on each side of the patient support 102. It is desirable to have multiple sets of holes 802 at different widths along the patient support 102.
  • One aspect of the invention includes an adapter 804 which contains fixation features for an immobilizer 114 that removably attaches to the device 100 and creates an additional set of locating features (e.g., holes) 802.
  • the adapter 804 may also be reversed and fixated to allow for a narrower set of mounting holes 802 in the device 100.
  • the distance between shoulder mask attachment points may be, for example, about 16.5 inches. Without the use of an adapter 804, the distance between shoulder mask attachment holes 802 may be, for example, about 21 inches. With the adapter 804 fixated to allow for a wider set of mounting holes 802, the distance between shoulder mask attachment points may be, for example, about 24 inches.
  • the options for attachment points may be located such that the main device holes are always accessible. The adapter 804 may be left on the device or may be quickly removed/reconfigured between patient setups.
  • the apparatus 100 may have different configurations, as shown in FIGURES 9A- 9D.
  • the patient support 102 may have a shorter length, for example, 130cm.
  • the patient support 102 may be, for example, 160cm in length.
  • the patient support 102 may be a standalone device including one or more pins 902a-902d and may be, for example, 160 cm in length.
  • the patient support 102 may also be MRI compatible (shown in FIGURE 9D).
  • FIGURE 10 shows exemplary geometry and dimensions of the patient support 102.
  • the length of the patient support 102 may be, for example, 130cm or 160cm.
  • the thickness of the patient support 102 may be, for example, about 1 inch.
  • the maximum width of the patient support 102 may be, for example, 21 inches.
  • a method for creating a customized system configured to position and immobilize a patient undergoing radiotherapy procedures comprises the following steps:
  • step (f) of the above described method may further comprise at least one of the following:
  • the method may further the following step interposed between steps (j) and (k) :
  • a method for positioning a patient utilizing a customized system configured to position and immobilize a patient undergoing radiotherapy procedures comprises the following steps:
  • the method further comprises the following step:
  • Embodiments of apparatus, systems, kits and methods provided according to aspects of this invention can aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery, and electron, photon and proton treatments.
  • the apparatus, systems, kits and methods are also useful during image acquisition to support treatment planning.
  • An apparatus for positioning and immobilizing a patient undergoing radiotherapy procedures comprising : a patient support configured to support a patient, the patient support having a body support region configured to support at least a portion of a body of the patient and a head support region configured to support the head and neck of the patient; an immobilizer configured to restrain a patient's anatomy, the immobilizer having at least one frame coupled to at least one formable sheet comprising low- melting temperature thermoplastic material which is formable at a first, elevated temperature and rigid at a second, lower temperature, wherein at least a portion of the at least one frame is configured to remain substantially perpendicular to a ray extending to a region of interest when coupled to the patient support, thereby creating a continuous transition area and minimizing or reducing impacts to imaging and treatment delivery; and releasable locks coupled to the at least one frame of the immobilizer and configured to be received by corresponding openings disposed on the head support region of the patient support, wherein the releasable locks are configured
  • the immobilizer further comprises at least one shim configured to adjust a distance between the at least one frame of the immobilizer and the patient support.
  • the immobilizer is further configured such that, when the distance between the at least one frame of the immobilizer and the patient support is adjusted, at least a portion of the at least one frame remains substantially perpendicular to a ray extending to the region of interest and the transition area between the at least one frame and the edge of the head support region remains substantially continuous.
  • the at least one shim is integrated into a structure of at least one of the at least one frame of the immobilizer or the patient support.
  • the apparatus of aspect 1, wherein the at least one shim is co-located with the structure of at least one of the releasable locks.
  • the head support region of the patient support is configured to support only a region defined by a back of a patient's neck and occipital region of a patient's head.
  • the body support region comprises structures configured to receive additional accessories.
  • the structures configured to receive additional accessories permit placement of the additional accessories continuously along a length of the body support region of the patient support.
  • a system for positioning and immobilizing a patient undergoing radiotherapy procedures comprising : the apparatus of aspect 1 and a posterior support configured to support a neck of the patient.
  • the system of aspect 17, wherein the posterior support is configured to be formed to a patient's anatomy.
  • the system of aspect 17, wherein the posterior support is activated by introducing water or heat, or by inflation with or evacuation of a fluid.
  • the system according to one of aspects 17, 18, or 19, further comprising at least one indexer configured to index the posterior support to a region of the patient support.
  • the at least one forming aid being configured to be removably attached to the patient support with releasable locks disposed on the forming aid and configured to be receivable by the corresponding openings in the patient support.
  • a method for creating a customized system configured to position and immobilize a patient undergoing radiotherapy procedures comprising the following steps:
  • step (f) further comprises:
  • step (f) further comprises:
  • An apparatus for positioning and immobilizing a patient undergoing radiotherapy procedures comprising : a patient support configured to support a patient, the patient support having a body support region configured to support at least a portion of a body of a patient and a head support region configured to support the head and neck of a patient; an immobilizer configured to restrain the patient's anatomy, the immobilizer having at least one frame coupled to at least one formable sheet comprising low- melting temperature thermoplastic material which is formable at a first, elevated temperature and rigid at a second, lower temperature, wherein at least a portion of the at least one frame remains substantially perpendicular to a ray extending to a region of interest when coupled to the patient support, thereby creating a continuous transition area and minimizing impacts to imaging and treatment delivery; releasable locks coupled to the at least one frame of the immobilizer and configured to be received by corresponding openings disposed on the head support region of the patient support, wherein the releasable locks are configured to couple the immobil
  • a kit for positioning and immobilizing a patient undergoing radiotherapy procedures comprising : a patient support having a body support region configured to support at least a portion of the patient and a head support region configured to support the head and neck of the patient, the head support region of the patient support having mounting apertures to which other components of the kit can be attached; a cushion shaping support configured to be removably attached at the mounting apertures of the head support region of the patient support for shaping a cushion to an anatomy of the patient; and a thermoplastic mask configured to be removably attached at the mounting apertures of the head support region of the patient support for immobilizing the anatomy of the patient.
  • kit of aspect 31 further comprising : a shoulder adapter configured to be removably attached to the body support region of the patient support.
  • kit of aspect 31 further comprising : a neck support configured to be positioned at the head support region of the patient support.
  • kit of aspect 31 further comprising : a hand grip configured to be removably attached to the body support region of the patient support.
  • kit of aspect 31 further comprising : a locating bar configured to be removably attached to the body support region of the patient support.
  • a system for positioning and immobilizing a patient undergoing radiotherapy procedures comprising : a patient support having a body support region configured to support at least a portion of the patient and a head support region configured to support the head and neck of the patient, the head support region of the patient support having mounting apertures to which other components of the kit can be attached; a cushion shaping support configured to be removably attached at the mounting apertures of the head support region of the patient support for shaping a cushion to an anatomy of the patient; and a thermoplastic mask configured to be removably attached at the mounting apertures of the head support region of the patient support for immobilizing the anatomy of the patient; wherein the cushion shaping support is attached at the mounting apertures of the head support region of the patient support when the cushion is shaped to an anatomy of the patient; and wherein the thermoplastic mask is attached at the mounting apertures of the head support region of the patient support when the anatomy of the patient is immobilized upon removal of the cushion shaping support.
  • the system of aspect 36 further comprising : a shoulder adapter configured to be removably attached to the body support region of the patient support.
  • the system of aspect 36 further comprising : a neck support configured to be positioned at the head support region of the patient support.
  • the system of aspect 37 further comprising : a hand grip configured to be removably attached to the body support region of the patient support.
  • the system of aspect 37 further comprising : a locating bar configured to be removably attached to the body support region of the patient support.

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Abstract

Un appareil de positionnement et d'immobilisation d'un patient soumis à des procédures de radiothérapie comprend un support de patient ayant une région de support de corps et une région de support de tête, un dispositif d'immobilisation ayant au moins un cadre couplé à une feuille formable de matériau thermoplastique à basse température de fusion, et des verrous libérables couplés au cadre du dispositif d'immobilisation, reçus par des ouvertures correspondantes disposées sur la région de support de tête, et configurés pour coupler le dispositif d'immobilisation à la région de support de tête. Au moins une partie du cadre reste sensiblement perpendiculaire à un rayon s'étendant jusqu'à une région d'intérêt lorsqu'elle est couplée au support de patient, créant ainsi une zone de transition continue et réduisant au minimum les impacts sur l'imagerie et l'administration de traitement. La région de support de tête réduit au minimum les obstructions à l'imagerie ou à l'administration de traitement et les verrous libérables sont positionnés de telle sorte qu'ils n'interfèrent pas avec l'imagerie ou l'administration de traitement, y compris la protonthérapie ou une autre thérapie par les ions lourds.
PCT/US2025/027526 2024-05-02 2025-05-02 Système et procédé de positionnement reproductible d'un patient soumis à des procédures de radiothérapie Pending WO2025231381A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463641810P 2024-05-02 2024-05-02
US63/641,810 2024-05-02

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016124232A1 (fr) * 2015-02-04 2016-08-11 Dynamic Systems Holding Bv Dispositif, système et procédé pour immobiliser une partie du corps humain
US20190117330A1 (en) * 2014-02-19 2019-04-25 Qfix Systems, Llc Adjustable immobilizer apparatus and method for immobilizing a patient
WO2023213365A1 (fr) * 2022-05-06 2023-11-09 Candor Aps Dispositif de réglage d'angle de tête et procédé de formation d'un moulage d'immobilisation de tête

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190117330A1 (en) * 2014-02-19 2019-04-25 Qfix Systems, Llc Adjustable immobilizer apparatus and method for immobilizing a patient
WO2016124232A1 (fr) * 2015-02-04 2016-08-11 Dynamic Systems Holding Bv Dispositif, système et procédé pour immobiliser une partie du corps humain
WO2023213365A1 (fr) * 2022-05-06 2023-11-09 Candor Aps Dispositif de réglage d'angle de tête et procédé de formation d'un moulage d'immobilisation de tête

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