PROFILE FOR THE ATTACHMENT OF AN IMMOBILISATION MASK

Abstract

Assembly of a carrier (3) for supporting a patient, an immobilisation mask (2) and connection means (13, 21, 22) for connecting the carrier (3) with the immobilisation mask (2), wherein the connection means (13, 21, 22) contain a profile (1) that is provided on a first side to be connected to the immobilisation mask (2) and on a second side contains first connection means (21) for connecting the immobilisation mask (2) to the carrier (3), the connection means (13, 21, 22) comprising carrier connection means (13) on the carrier (3), the first connection means (21) being provided to engage the corresponding carrier connection means (13), wherein a swivel and a swivel anchor point (36) are provided to cooperate such that when swivelling the swivel arm (34) around the swivel anchor point (36) towards the carrier (3), the first connection means (21) are guided to the connected state.

Claims

1-73. (canceled)

74. Profile for connecting a carrier (3) to an immobilisation mask for immobilizing a body part of a patient on the carrier (3), wherein the profile (1) contains at a second side first connection means (5, 15, 21) for connecting the profile (1) to the carrier (3), and at a first side opposite to the second side, second connection means (22) for connecting the profile to the immobilisation mask, and wherein the first connection means (5, 15) are provided, in a connected state, to engage corresponding connection means (13) of the carrier (3), characterized in that the profile (1) comprises a swivel arm (34) provided to cooperate with a swivel anchor point (36) provided to the carrier (3), the swivel arm (34) and the swivel anchor point (36) being provided to cooperate such that when swivelling the swivel arm (34) around the swivel anchor point (36) towards the carrier (3), the first connection means (21) are guided to the connected state where they engage the corresponding connection means of the carrier (3).

75. Profile according to claim 74, wherein the swivel arm (34) and the swivel anchor point (36) engage each other.

76. Profile according to claim 74, wherein the engagement of the swivel arm (34) and the swivel anchor point (36) has substantially a single degree of freedom.

77. Profile according to claim 76, wherein the angle of rotation of the swivel arm (34) around the swivel anchor point (36) during swivelling of the swivel arm (34) is the substantially single degree of freedom.

78. Profile according to claim 74, wherein the swivel arm (34) comprises a gripping part (35) provided to grip at least partly around the swivel anchor point (36).

79. Profile according to claim 78, wherein the swivel anchor point (36) comprises a cylindrical protrusion provided to be surrounded at least partly by the gripping part (35) when it grips at least partly around the swivel anchor point (36).

80. Profile according to claim 74, wherein the swivel arm (34) and the swivel anchor point (36) are connected to each other in a hinge joint.

81. Profile according to claim 74, wherein the first connection means (21) on the profile (1) contains mask connection means (5, 15) that are complementary to and are provided to cooperate with the corresponding carrier connection means (13), and whereby the corresponding carrier connection means (13) are positioned along an outer edge (4) of the carrier (3).

82. Profile according to claim 74, wherein the first connection means (21) comprise an upper lip (10) that is provided, in the connected state, to extend along the upper surface (14) of the edge of the carrier (3), and wherein the first connection means (21) comprise a first lower lip (5) that is provided, in the connected state to extend along the lower side (31) of the carrier (3) and to engage the corresponding connection means (13) at a lower side of the carrier (3).

83. Profile according to claim 82, wherein the lower lip (5) is arranged resiliently.

84. Profile according to claim 82, wherein the first lower lip (5) on a side directed to the carrier (3) is provided with a protrusion (15) that is provided, in the connected state, to engage the corresponding connection means (13) at a lower side of the carrier (3).

85. Profile according to claim 82, wherein the first connection means (21) further comprise a second and third lower lip (6, 7) at opposite sides of the first lower lip (5), wherein the second and third lower lip (6, 7) are provided to extend along the lower side of the carrier (3).

86. Profile according to claim 74, wherein the swivel arm (34) extends along the first connection means (21).

87. Profile according to claim 74, wherein the swivel arm (34) extends along the second connection means (22).

88. Immobilisation mask for immobilizing a body part of a patient on a carrier (3), wherein the immobilisation mask (2) comprises a sheet (8) of a thermoplastic material for receiving the body part to be immobilized, and at least one profile (1) for connecting the immobilisation mask (2) to the carrier (3) according to claim 74, wherein the profile (1) is connected to the sheet (8) of thermoplastic material at the first side of the at least one profile (1) comprising the second connection means (22).

89. Immobilisation mask according to claim 88, wherein the sheet (8) of thermoplastic material for receiving the body part to be immobilized is chosen from the group, consisting of thermoplastic elastomers, thermoplastic polyurethane, thermoplastic polyisoprene, thermoplastic polyesters, thermoplastic polyolefins, polyvinyl chloride, polystyrene, or a blend of two or more of these materials.

90. Immobilisation mask according to claim 88, wherein the sheet (8) of thermoplastic material is covered with an antibacterial coating.

91. Assembly for radiation therapy, for example proton therapy, of a carrier (3) for supporting a patient, and an immobilisation mask (2) according to claim 88 connectable with the carrier (3) for immobilizing a body part of the patient onto the carrier (3)

92. In a method for immobilizing a body part of a patient on a carrier using an immobilization mask, the improvement wherein the immobilization mask is in accordance with claim 88.

93. A method in accordance with claim 92, wherein the method is for immobilizing a body part of a patient in the course of radiation therapy.

Description

[0037] The invention is illustrated in the accompanying drawings which display preferred embodiments and describe the profile, the immobilisation mask provided with a profile, and an assembly of a carrier, an immobilisation mask and profile for the connection of the immobilisation mask to the carrier or base plate or carrier on which the patient rests. The invention is further illustrated in the description of the figures of these preferred embodiments. In the following figure description, the same reference numbers refer to the same elements.

[0038] FIG. 1 shows a view of the lower side of the connection means (profile) for connecting an immobilisation mask with the carrier for supporting a patient or a portion thereof.

[0039] FIG. 2 shows a cross-section along the line II-II in FIG. 1.

[0040] FIG. 3 shows a cross-section along the line III-III in FIG. 1.

[0041] FIG. 4 shows a view to the upper side of a carrier.

[0042] FIG. 5 shows a view to the lower side of a carrier.

[0043] FIG. 6 shows an immobilisation mask in the connected state with the carrier.

[0044] FIG. 7a shows a view to the immobilisation mask connected with a carrier according to the state of the art. FIG. 7b shows a cross-section of FIG. 7a. FIG. 7c shows a view of the carrier used in FIG. 7a.

[0045] FIGS. 7a, 7b and 7c show the way in which in the state of the art a connection was established between a mask 26 for immobilizing a body part of a patient, for example the head, and a carrier 27 on which the patient rests. As is shown in FIG. 7a, it is known from the state of the art to provide an L- shaped profile 25 along the edge of the mask that engages an opening or slot 28, provided in the surface of the carrier, in the region of the position where the patient rests. The slot 28 needs to be relatively wide, to enable the displacement of the L-shaped profile through the slit to enable its application. To fixate the position of the profile into the slot and to prevent displacement, it is necessary to apply a positioning block 29 or the like into the slot. The presence of the slot, the L-shaped profile and the positioning block disrupt the homogeneity of the material of the carrier at the position where the patient is located, so that there is a risk that the desired radiation dose into the tissue is not achieved.

[0046] A view to an upper side of a preferred embodiment of a carrier or base plate 3 for supporting a patient in radiation therapy is shown in FIG. 4. The preferred embodiment shown in FIG. 4 of the carrier 3 contains a top support surface 14 for supporting the patient. With “along” is meant that the connection means are located at a distance of the edge 4 of the carrier 3 or may be provided in one piece with the carrier, dependent on the nature of the connection means 21 on the profile. Along the edge of the carrier 3, preferably carrier connection means 13, as opposed to mask connection means 21, 22, comprising the first and the second connection means 21, 22, extend at least at one position, that are provided to cooperate with the mask connection means 21, 22 for the connection of the immobilisation mask 2 with the carrier 3. Along the edge 4 of the carrier 3, there is provided preferably on at least one position, an opening 13 for receiving connection means 1 for attaching the immobilisation mask 2 to the carrier 3. Along the edge 4 of the carrier 3, there is provided at least one swivel anchor point 36 for cooperation with swivel arm 34 extending along the connection means 1. More preferably, two or more openings 13 are provided. The amount of openings 13 is usually chosen such that a sufficient amount of profiles 1 can be applied to enable a stable and accurate fixation of the position and posture of the body part of the patient and to allow not more than the desired range of motion. The openings 13 may be applied at random positions along the edge 4 of the carrier. However, preferably, the openings 13 are applied symmetrically relative to the longitudinal axis of the carrier to attain optimal distribution of the tension and tensile force over the immobilisation mask 2 and to enable optimal derivation thereof to the carrier 3 (see FIG. 4). It is further possible to choose the amount of openings 13 such that the carrier 3 is suitable for immobilizing multiple body parts with varying size. Every other arrangement of openings 13 considered suitable by the person skilled in the art may be chosen.

[0047] Furthermore, the carrier 3 along the edge 4 is preferably, at least on position 20, deformed for receiving a profile 1 for attaching the immobilisation mask 2 to the carrier 3. The deformation 20 is preferably such that it is sufficiently large to receive the upper lip 10 of the profile 1 in such a way that the upper surface of the upper lip 10 is flush with the support surface 14 of the base plate or carrier 3 to increase the comfort of the patient. The presence of the deformation 20 hampers the displacement of the profile 1 along and relative to the edge of the carrier 4 and contributes in this way to the provision of a stable, accurate and reproducible connection to the immobilisation mask 2 with the carrier. The deformation also counteracts the possibility of rotation of the profile 1 relative to the carrier 3. Preferably, two or more deformations 20 are provided. The number of deformations 20 is usually chosen such that a sufficient amount of profiles can be applied to enable a stable and accurate fixation of the position and posture of the body part of the patient and to allow no more than the desired range of motion. However, the presence of the deformation is not critical for the invention and can be omitted.

[0048] The dimensions and shape of the deformations 20, if present, may be random. The deformation 20 preferably has the shape of a recess relative to the upper side of the carrier. In other words, the upper surface of the deformation 20 is preferably lowered relative to the upper surface 14 of the carrier. This is shown in FIG. 5. Preferably, the dimensions of the deformations 20 in the longitudinal direction along the edge 4 of the carrier and the dimensions of the deformation 20 in the traverse direction on the carrier 3 are aligned with the dimensions of the profile 1 or connection means that are provided to be incorporated into this deformation. The deformation 20 preferably has nearly the same dimensions as the profile 1 or is slightly larger than the profile 1, such that the profile 1 or at least the upper lip 10 of the profile can be incorporated in the deformation 20. The deformation 20 may function, at the application of the profile, as a guide for guiding the displacement of the profile 1 during the establishment of the connection between the mask 2 and the carrier 3. Since the raised edge of the deformation forms a barrier, the displacement of the profile 1, once installed, is opposed, and the deformation 20 contributes to the stable and accurate fixation of the position and posture of the body part of the patient so as to allow no more than the intended range of motion.

[0049] A view to the lower side of a preferred embodiment of a commonly used carrier 3 for supporting a patient, especially in proton therapy, is shown in FIG. 5. At a position between the edge 4 of the carrier and the opening 13, a guide 11, 111 is preferably provided at the lower side of the carrier for guiding the displacement of the profile 1 at the establishment of the connection of the immobilisation mask 2 with the carrier 3, for example for guiding the displacement of the first lower lip 5 on the profile 1. A preferred embodiment of the guide 11 has for example the shape of two opposite protrusions 11 or rails, in between which, for example, the lip 5 of the profile 1 is displaceable at the establishment of the connection. The two opposite protrusions 11 can however also be positioned such that in between them, two opposing side edges of a profile can be slid, as for example shown in FIG. 5 for a profile not comprising a swivel arm and therefore not according to the invention. In such embodiment, the guide 11 for example has the shape of two opposite protrusions 11 or rails, in between which, for example, the second and the third lip 6, 7 are displaceable at the establishment of the connection. Otherwise, the guide 111 may also have the shape of a single protrusion provided to slide along an edge of the profile 1 according to the invention, preferably opposing the side of the profile from which the swivel arm 34 extends. Once the connection has been established, the protrusions counteract a displacement of the profile, for example the lip 5 and if present the second and the third lip 6, 7, in a direction along the edge and therefore contribute to a stable and accurate fixation of the position and posture of the body part of the patient. Instead of the protrusions or rails 11, an alternative guide, for example a slot or any other alternative deemed suitable by the person skilled in the art, may be used that is adapted to embodiment of the lower lip 5 and, if present, the second and the third lip 6, 7.

[0050] The connection means, more in particular the mask connection means of the connection means, preferably comprise a profile 1 with first connection means 21 at a first side of the profile along which the profile is connectable to the carrier 3, and second connection means 22 at a second side of the profile 1 opposite the first side along which the profile 1 is connectable to the immobilisation mask 2. The first connection means 21 are provided, in the connected state, to engage an outer edge of the carrier. Such connection means enable to establish a connection between the immobilisation mask 2 and the carrier 3, also when the profile is subjected to high tension. The first connection means 21 preferably engage in the thickness direction the outer edge of the carrier. In a possible embodiment, the first connection means 21 exercise a clamping force onto the carrier 3.

[0051] The first connection means 21 preferably comprise an upper lip 10 that is provided to extend, in the connected state, along an upper surface or side of the carrier 14. Preferably, the upper lip 10 is incorporated in a corresponding deformation 20 along the upper surface 14 of the carrier 3. To enable a greater transmission of forces between the immobilisation mask 2 and the carrier 3, the upper lip 10 preferably extends in the longitudinal direction along the edge 4 of the carrier 3. The upper lip 10 may, for example, be curved to optimally follow the shape of the immobilisation mask 2, the upper lip 10 may however also be flat and rectangular or may take any other appropriate shape. The edge 33 of the upper lip may, for example, be curved to optimally follow the shape of the edge of the immobilisation mask as shown in FIG. 1. The upper lip 10 increases the stability of the mask in the connected state with the carrier, since a tilting movement of the profile is counteracted.

[0052] The first connection means 21 preferably also comprise at least one lower lip 5 that is provided to extend in the connected state along a lower surface or lower side of the carrier 31. More preferably, the first connection means 21 comprise a lower lip 5 that is provided on the side directed to the carrier with a protrusion 15 that is provided, in the connected state, to engage corresponding connection means on the lower side of the carrier 3. Preferably, protrusion 15 engages a corresponding opening 13 in the carrier 3. The opening 13 may extend throughout the entire thickness of the carrier 3 or over a section thereof. The first connection means 21 further preferably comprise on a first side of the lower lip 5 a second lower lip 6 which preferably extends in the longitudinal direction along the edge of the carrier 3. The first connection means 21 further preferably comprise at a second side of the lower lip 5 opposite the first side in transverse direction of the lower lip 5, a third lower lip 7 which preferably extends in the longitudinal direction along the edge of the carrier 3. With a resiliently arranged lip 5, an easily detachable connection is provided between the profile 1, in particular between the profile and the carrier 3. The second and third lip 6, 7 may have the same or different shapes, but preferably have a corresponding shape. The second and third lower lips 6, 7 may, for example, be curved to optimally follow the shape of the immobilisation mask, they may however also be rectangular or may take any other appropriate shape. The presence of the second and third lower lip 6, 7 increases the stability of the mask in the connected state with the carrier, since a tilting movement of the profile 1 is counteracted.

[0053] Preferably, at least one swivel arm 34 is provided extending along the connecting means 21, to connect with a corresponding swivel anchor point 36 located on the lower side of the carrier 31.

[0054] As can be seen in the figures, the swivel arm 34 and the swivel anchor point 36 can engage each other. In the embodiment shown in the figures, the engagement of the swivel arm 34 and the swivel anchor point 36 has substantially a single degree of freedom, in this case the angle of rotation of the swivel arm 34 around the swivel anchor point 36 during swivelling of the swivel arm 34. As can be seen in FIG. 1, the swivel arm 34 comprises a gripping part 35 provided to grip at least partly around the swivel anchor point 36. The gripping part 35 shown is in the form of a semi-circular shape provided to grip around a corresponding swivel anchor point 36. In the figures, the swivel gripping point 36 is in the form of a cylindrical protrusion provided to be surrounded at least partly by the gripping part 35 when it grips at least partly around the swivel anchor point 36. Such a connection can be provided in the form of a hinge joint allowing a single degree of freedom, in this case begin the angle of swivelling.

[0055] As can be seen in FIG. 1, the swivel arm extends along the first connection means 21 and the second connection means 22. Other embodiments are however possible, according to the desired configuration and depending on the specific use situation.

[0056] In FIG. 6 it can be seen that the body part to be immobilized is a head and the swivel anchor point 36 is provided below the mandible of the patient positioned on the carrier 3, more in particular, although not shown in FIG. 6, the swivel anchor point is provided below the mental protuberance of the mandible of the patient, even more in particular the swivel anchor point is provided at the height of the Adam's apple of the patient. It can further be seen that the body part is a head and the swivel anchor point 36 is located along the neck of a patient positioned on the carrier 3, more in particular above the clavicle of the patient.

[0057] FIG. 6 further shows the relative difficult position of the different connection means 21, 22 in light of attaching the connection means 21, 22 to the carrier 3.

[0058] Preferably, the outer surface of lip 5 further contains a second lip 32 that counteracts or even prevents a movement of the lip 5 that is directed away from the space 9. The presence of such lip however is not critical for the invention and the lip 32 can therefore be omitted.

[0059] The opening 13 can be arranged centrally in the deformation 20, if present, or asymmetrically.

[0060] The at least one upper lip 10 and at least one lower lip 5, 6, 7, of the first connection means 21 are preferably arranged at a distance from one another and are connected to each other at a connection position 24. Thereby, the first distance between the at least one upper lip 10 and at least one lower lip 5, 6, 7, is preferably chosen such that, at one first side of the connection position 24, it is sufficiently large for receiving a section of the carrier 3 that extends along the edge 4 thereof. The second connection means 22 preferably contain also an upper and a lower lip 16, 17 that are connected to each other at the connection position 24. The upper and lower lip 16, 17 are preferably arranged at a second distance from each other that is sufficiently large for the inclusion of the material along the edge of the immobilisation mask. The first distance can be equal to the second distance, or may be different from it. Connection position 24 connects the first 21 and second connection means 22.

[0061] The first connection means 21 for connecting the profile to the carrier 3, preferably extends in a first direction relative to the connection position 24, in particular in the direction of the carrier 3. The second connection means 22 that connect the profile 1 to the immobilisation mask preferably extend in opposite direction relative to the first connection means 21 and the connection position 24, in particular in the direction of the immobilisation mask.

[0062] The carrier 3 may be provided in every material deemed suitable by the person skilled in the art. The carrier is for example conducted as a plate of carbon fibres impregnated with epoxy resin. However, other materials may be used.

[0063] The profile 1 may be provided in one piece with the immobilisation mask 2 or as a separate component. Preferably, it is provided in one piece with the mask 2 in order to absorb higher tensile forces on the mask with minimal risk of releasing the profile 1. The profile 1 may be provided in another material than the mask, such that for both components the material may be chosen that is optimally adapted to the selected function it performs. This offers, for example, the possibility to choose the material for the mask such that it may directly be shaped to the patient, and to choose the material of the profile 1 such that it exhibits an optimal mechanical strength and minimal deformation to ensure an accurate and reproducible positioning.

[0064] Suitable materials for manufacturing the immobilisation mask are for example thermoplastic elastomers, thermoplastic polyurethane, thermoplastic polyisoprene, thermoplastic polyesters, thermoplastic polyolefins, polyvinyl chloride, polystyrene, or a blend of two or more of these materials. Preferred are these polymers that have a relatively low softening temperature wherein the material is deformable, such that these are exceptionally suitable for the manufacturing of immobilisation mask that can directly be formed onto the body part to be immobilized. The body part to be immobilized then serves as a mould for shaping the immobilisation mask. Examples of suitable thermoplastic polyolefins comprise polyethylene, polypropylene or ethylene-propylene co-polymers. Examples of suitable thermoplastic polyesters comprise polyethylene vinyl acetate, polyacrylates or polymethacrylate, polymeric fatty acid esters, in particular poly-ε-caprolactone, for example poly-ε-caprolactone such as available at Perstorp (UK) under the trade name Capa®. Preferred are the polymers of the group of thermoplastic polyurethane, isotactic polypropylene, copolymers of ethylene with 1-butene, a copolymer of ethylene with 1-octene, poly-ε-caprolactone, poly-ε-caprolactone containing thermoplastic polyurethane, as well as mixtures of two or more of these materials. Poly-ε-caprolactone is especially preferred because it has a low melting point and is deformable at temperatures that the human body can tolerate.

[0065] Suitable materials for manufacturing the profile are ABS, polyoxymethylene, polyamide or other equivalent materials.

[0066] This invention also concerns an immobilisation mask for immobilizing a body part of the patient in a previously determined posture of the carrier 3, wherein the immobilisation mask is provided with a profile 1 as described above, for connecting the mask 2 to the carrier 3 for supporting the patient. Preferably, the profile 1 is attached to the mask 2 along the edge of the mask 12, by incorporating the edge 12 of the mask in the second space 19 at the second connection means 22. Attachment can be done, for example, by gluing, by welding, by means of a mechanical connection or by any other connection deemed suitable by the person skilled in the art. Preferably, the connection is established by gluing or welding. Preferably, the profile 1 is as described above. To enable an optimal positioning and immobilizing along the edge of the mask, usually multiple profiles 1 will be applied.

[0067] This invention further concerns the profile 1 for connecting an immobilisation mask 2 to the carrier 3, wherein the mask 2 is provided for immobilizing a body part of a patient in a predetermined posture on the carrier. Preferably, the profile 1 is as described above.

[0068] Connecting an immobilisation mask 2 to the carrier 3 upon which a patient rests, for immobilizing for example the head of the patient occurs by covering the head of the patient with the immobilisation mask that was shaped to the head of the patient. When use is made of an immobilisation mask on which along the edge a plurality of profiles are attached, a connection is established by incorporating the edge 4 of the carrier 3 in the first space 9 of the profile 1 at the side of the first connection means 21, preferably at the height of a recess 20 in the carrier 3. When establishing the connection, the profile is usually placed transversal to the edge 4 of the carrier 3 in the direction of the middle of the carrier 3. The displacement of the profile 1 may be guided by the edges of the recess or deformation 20 at the upper side of the carrier 14 and by the guide 11 at the lower side 31 of the carrier that guides the displacement of the first lip 5 along the lower side 31 of the carrier 3 till the protrusion 15 engages the carrier at the first lip 5 in the corresponding opening 13.

LIST OF REFERENCE NUMBERS

[0069] 1. profile [0070] 2. immobilisation mask [0071] 3. carrier for patient [0072] 4. edge carrier for patient [0073] 5. first lower lip [0074] 6. second lower lip [0075] 7. third lower lip [0076] 8. sheet [0077] 9. first space [0078] 10. upper lip [0079] 11. guide [0080] 12. edge mask [0081] 13. carrier connection means [0082] 14. support surface carrier for patient [0083] 15. protrusion on first lower lip [0084] 16. upper lip second connection means [0085] 17. lower lip second connection means [0086] 18. [0087] 19. second space [0088] 20. deformation in carrier [0089] 21. first connection means [0090] 22. second connection means [0091] 23. [0092] 24. connection position [0093] 25. L-shaped profile [0094] 26. immobilisation mask [0095] 27. carrier [0096] 28. slot in carrier [0097] 29. EVA block- [0098] 30. [0099] 31. lower side carrier [0100] 32. second lip [0101] 33. edge upper lip [0102] 34. swivel arm [0103] 35. gripping part [0104] 36. swivel anchor point [0105] 111. lateral guide