Classifications

• • 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
  • 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
• • 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
  • A61B90/17—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins for soft tissue, e.g. breast-holding devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
  • A61F5/37—Restraining devices for the body or for body parts; Restraining shirts
  • A61F5/3707—Restraining devices for the body or for body parts; Restraining shirts for the head
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
  • A61G13/00—Operating tables; Auxiliary appliances therefor
  • A61G13/10—Parts, details or accessories
  • A61G13/12—Rests specially adapted therefor; Arrangements of patient-supporting surfaces
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
  • A61G13/00—Operating tables; Auxiliary appliances therefor
  • A61G13/10—Parts, details or accessories
  • A61G13/12—Rests specially adapted therefor; Arrangements of patient-supporting surfaces
  • A61G13/1205—Rests specially adapted therefor; Arrangements of patient-supporting surfaces for specific parts of the body
  • A61G13/121—Head or neck

Definitions

• the present invention concerns a patient immobilisation assembly for restraining a patient's head.
• embodiments of the present invention concern devices for immobilising the head and neck of a patient during radiotherapy.
• Radiotherapy is a form of cancer treatment which involves the application of radiation directed to a particular situs in a patient's body.
• the applied radiation destroys targeted cancer cells.
• the radiation can also affect some of the normal cells nearby.
• the destruction and damage of nearby healthy tissue can result in severe side effects due to the presence of many critical structures and organs in that part of the body. For this reason, it is very important that radiation is targeted as far as possible so as to destroy only the cancerous cells whilst leaving other nearby structures intact.
• Devices immobilising the position of a patient's head and neck are used to improve the accuracy and reproducibility of positioning the head and neck in medical diagnostic and treatment procedures. These devices are particularly important when a patient is undergoing fractionated radiation therapy where radiation is applied to a patient on a number of different occasions. When undergoing fractionated treatment it is important to try to ensure that a patient is placed in the same position for each treatment session so that the same location can be irradiated throughout the course of treatment.
• a chin strap One of the simplest approaches to assist a patient to maintain their position is with use of a chin strap.
• this approach fails to immobilise the head and neck completely which increases the chances of a patient moving during a treatment session and hence the dangers of detrimental side affects.
• a simple chin strap also fails to ensure that a patient will be positioned consistently during the course of multiple treatment sessions.
• a full-face mask is normally made out of a thermoplastic material which is heated prior to an initial treatment session. The mask is then moulded to a patient's head by being placed over the patient's face and then allowed to set. The resultant full- face mask completely encloses a patient's head and thus restricts movement and allows a patient to be placed into a fixed position for each treatment session. Examples of such full face masks are disclosed in WO03/061477and WO04/032781 .
• the mask covers the vast majority or the entirety of a patient's face with only small apertures for eyeholes, some patient's find existing masks claustrophobic and uncomfortable. Further, although the full-mask approach substantially limits a patient's movement as the mask encloses a patient's head, it is still possible for small movements to occur within the mask. Further as the mask completely obscures a patient's face it is not possible to monitor for movement during treatment.
• WO00/27331 An alternative head restraint for maintaining the position of a patient during a medical procedure such as imaging by position emission tomography (PET) or magnetic resonance imaging (MRI) is disclosed in WO00/27331.
• PET position emission tomography
• MRI magnetic resonance imaging
• WO 00/27331 is an example of a prior art head restraint for use with a tracking system as such the face leaves a portion of the face unobscured.
• the design of the mask of WO 00/27331 suffers from similar problems to the chinstrap prior art.
• An alternative immobilisation assembly that assists with precise positioning of the patient's head during repeated and subsequent treatments and examinations whilst increasing a patient's comfort is therefore desirable.
• a blank for a head restraint comprising: a frame; and a sheet extending across the frame wherein a main aperture and a pair of auxiliary apertures are provided in the sheet, the arrangement of the apertures being such that when the sheet is deformed upon placement on a patient's head the main aperture is such to leave a patient's face substantially free of the sheet and the auxiliary apertures are such to cause a retaining strut to be formed by portions of the sheet between said main aperture and said auxiliary apertures.
• Figure 1 is a frontal view of a blank for an immobilising head restraint in accordance with an embodiment of the present invention.
• Figure 2 is a perspective view of the head and neck of a patient wearing a head restraint formed from the blank of Figure 1.
• Figure 1 is a front view of a head restraint blank 1 in accordance with a first embodiment of the present invention.
• the blank 1 is also illustrated in Figure 2 which comprises a schematic perspective view of the head restraint blank 1 after deformation by a patient's head 4.
• the blank head restraint 1 comprises a rigid U-shaped frame 2 with an integrally formed perforated sheet 3.
• the perforated sheet 3 is made from a thermoplastic which when heated can be deformed by being placed over a patient's head.
• the perforated sheet has three large apertures comprising a main central aperture 10 and two subsidiary triangular apertures 12, 13 provided either side of the main central aperture 10.
• a series of screw holes 14 are provided in the frame 2 enabling the frame 2 to be attached to a restraint platform.
• the arrangement of the apertures 10, 12, 13 in the perforated sheet 3 is such that when the blank 1 is deformed by being placed over a patient's face, the perforated sheet 3 is moulded and stretched to sculpt the contours of the patient's head whilst leaving the patient's face, including eyes, nose and mouth, to be uncovered.
• the portions of the perforated sheet 3 between the apertures 10, 12, 13 are stretched so as to form a chin strap 20 and a pair of accompanying side struts 22 either side of the patient's face which together act to restrain the patient's head 4 in place whilst giving the deformed sheet 3 substantial structural rigidity thus ensuring that despite the fact that the patient's face is unenclosed, the mask acts to retain the patient's head 4 in a fixed position when it lies on a cushion 23 provided as part of a restraint platform.
• non-contact motion detection systems such as Vision RT's AlignRT R TM system such as is disclosed in WO2004/004828.
• the perforated sheet 3 substantially fills the entirety of the U-shaped frame 2 with the edge 25 of the perforated sheet 3 at the open end of the U-shaped frame 2 following a serpentine curve initially running approximately perpendicularly to the arms of the frame 2 before moving away from the apex of the U- shaped frame 2 so as to provide a small additional protrusion 26 in the central portion of the sheet 3.
• this protrusion 26 is such to enable the portion of the perforated sheet 3 to form a chin strap 20 which encloses a patient's chin when the blank 1 has been deformed.
• the main central aperture 10 comprises a central rectangular portion 28 and two adjacent wing portions 29, 30 where, the central rectangular portion 28 extends across the middle third of the perforated sheet 3 with the longer sides of the central rectangular portion 28 running parallel with the arms of the U-shaped frame 2.
• the two wing portions 29, 30 each comprise right angled triangular openings each with bases extending half way down the long sides of the central rectangular portion 28 and with each two wing portion 29, 30 having an apex level with the edge 25 of the central rectangular portion 28 remote from the edge 25 of the perforated sheet 3 half way between the long side of the central rectangular portion 28 and the edge 25 of the U- shape frame 2.
• some areas of the sheet 3 are left free of perforations. More specifically, other than in a central area 35 of the section of the sheet 3 and a band 36 immediately adjacent to the open end of the U-shaped frame 2, the portion of the sheet 3 adjacent to the open end of the U-shaped frame 2 is left free from perforations. In use this causes the central area 35 and the section of sheet 3 immediately adjacent to the open end of the U-shaped frame 2 to deform more easily and so accommodate the shape of a patient's chin. Also a band 37 of sheet 3 running across the edge of the main aperture 10 remote from the open end of the U-shaped frame 3 extending across to the arms of the frame 2 is also left free from perforations.
• the two subsidiary triangular apertures 12, 13 each comprise a right-angled triangular opening.
• the two subsidiary triangular apertures 12, 13 lie either side of the main central aperture 10 with a base adjacent to the arms of the U-shaped frame 2 and apex level with the end of the edge of the central rectangular portion 28 of the main central aperture 10 with the hypotenuses of the winged portions 29, 30 of the main aperture 10 and the triangular apertures 12, 13 being parallel to each other.
• the edges of main aperture 10 and the two subsidiary triangular apertures 12, 13 define the edges of a pair of strips 32, 34 of the perforated sheet 3 lying either side of the main aperture 10 connecting the U-shaped frame 2 with the portion of the sheet 3 adjacent to the open end of the U-shaped frame 2.
• these strips 32, 34 are deformed so as to form the struts 22 connecting the chin strap 20 formed from the portion of the sheet 3 adjacent to the open end of the U-shaped frame 2 with a portion of the U-shaped frame 2 further from the open end of the frame 2.
• the perforated sheet 3 will resist further deformation when placed under tension.
• the lower portion of the deformed sheet 3 acts to retain a patient's head 4 in position as this portion of the sheet 3 forms a chin strap 20 which prevents movement of a patient's chin away from the plane of the U-shaped frame 2.
• the portion of the perforated sheet 3 remote from the open end of the U- shaped frame 2 prevents forehead of a patient 4 from being moved away the plane of the U-shaped frame 2.
• main aperture 10 consists of a central rectangular portion 28 and two adjacent wing portions 29, 30, it will be appreciated that the present invention is not limited to this arrangement and a main aperture 10 may have alternative configurations. Thus for example, embodiments could be provided where the main aperture lacks winged portions 29, 30. Alternatively the main aperture could be triangular or in the form of a parallel trapezium. Additionally rather than having straight sides any or all the edges of the main aperture 10 could be curved.
• the wing portions 29, 30 of the main central aperture 10 parallel to the two subsidiary apertures 12, 13, it will be appreciated that the present invention is not limited to these apertures being triangles as illustrated in Figure 1 and 2 and similar arrangements could be provided where the wing portions 29, 30 and two subsidiary apertures 12, 13 comprise of a enclosed apertures with two concave sides.
• edges of the main aperture 10 and the subsidiary apertures 13 should be approximately parallel to each other to assist in the formation of a suitable retaining strut 22.
• the perforated sheet 3 may have perforations of different sizes.
• the arrangement of perforations should be such that large perforations are provided in portions of the sheet 3 which are required to under go greater amounts of deformation.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Engineering & Computer Science (AREA)
• Public Health (AREA)
• Biomedical Technology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Medical Informatics (AREA)
• Heart & Thoracic Surgery (AREA)
• Molecular Biology (AREA)
• Neurosurgery (AREA)
• Pathology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Otolaryngology (AREA)
• Physics & Mathematics (AREA)
• High Energy & Nuclear Physics (AREA)
• Optics & Photonics (AREA)
• Biophysics (AREA)
• Radiology & Medical Imaging (AREA)
• Vascular Medicine (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Nursing (AREA)
• Radiation-Therapy Devices (AREA)
• Orthopedics, Nursing, And Contraception (AREA)
• Respiratory Apparatuses And Protective Means (AREA)

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• 2009
  • 2009-01-26 GB GB0901220.4A patent/GB2467160B/en active Active
• 2010
  • 2010-01-22 US US13/145,667 patent/US8662083B2/en active Active
  • 2010-01-22 JP JP2011546963A patent/JP5226133B2/ja active Active
  • 2010-01-22 WO PCT/GB2010/050095 patent/WO2010084354A1/en not_active Ceased

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