WO2025068342A1

WO2025068342A1 - Body supporting device for supporting a body part during a medical treatment

Info

Publication number: WO2025068342A1
Application number: PCT/EP2024/077012
Authority: WO
Inventors: Johannes UITERWIJK
Original assignee: Herosupport Sa
Current assignee: Herosupport Sa
Priority date: 2023-09-27
Filing date: 2024-09-26
Publication date: 2025-04-03
Anticipated expiration: 2026-03-27

Abstract

A body supporting device (101) for mounting on a treatment board (102) of a radiation treatment system (100), the treatment board configured for receiving a patient thereon and having a radiation access orifice (103) in which the body supporting device (101) is configured to be removably mounted. The body supporting device comprises a shell (2) and a support frame (4) coupled to the shell, the support frame including a board mounting base (20) configured to be mounted against a border of the radiation access orifice of the treatment board.

Description

Body Supporting Device for Supporting a Body Part during a Medical Treatment

Technical Field

The invention refers to a body supporting device for supporting a body part during a medical treatment, in particular a cancer treatment. In addition, the invention refers further to method for manufacturing a body supporting device for supporting a body part on a treatment board during a medical treatment. In addition, a set comprising the body supporting device and the treatment board is claimed. A computer-readable medium storing data defining both a digital representation of the body supporting device and operating instructions is claimed as well as a computer program for conducting the method steps.

Background of the Invention

There are medical treatments, like radiation treatment for cancer patients that require a reproducible positioning of a patient. In particular radiation treatment requires precise alignment of a body part of a patient for multiple treatment sessions.

WO 2020/099510 A2 discloses a positioning and shaping shell manufacturing method for manufacturing a positioning and shaping shell comprising a positioning step consisting in positioning and supporting a target body portion with a transparent body shaper in a predetermined position on a positioning board presenting at least one transparent portion permitting scanning through it, an image acquisition step consisting in a target body portion surface scan imaging also via the transparent portion of the board and said transparent body support, a software computing step where the acquired image data are sent and processed in a processing unit, and a producing step consisting in producing a 3D positioning and shaping shell model via additive or subtractive manufacturing method based in the processed image data.

The document discloses a treatment board that has many advantages for treating a patient. However, the shaping shell does not provide very precise repeatable alignment of the patient as it is required for some radiation treatment.

Summary of the Invention

The aforementioned problem is solved in a first aspect by a body supporting device for supporting a body part during a medical treatment, in particular a cancer treatment that comprises a shell adapted to receive the body part. The body contact side of the shell is a replica of the surface shape of the respective body part. Replica of the body part means that the surface shape of the respective body part is reproduced such that the body contact side of the shell follows essentially exactly the surface of the body part.

The replica is manufactured by means of generating 3D image data from a scan of the respective body part and subsequently producing the shell from the 3D image data by additive manufacturing. By scanning the respective body part, e.g. a patient’s breast, the shell is perfectly adapted to serve as a support for the body part when it supports the body part during treatment of the same.

A body contact side of the shell comprises a structured surface, in particular a regular structure pattern, in particular a structure pattern of holes or through holes respectively cylinders that go through the material. Wherein in the intended use of the device, the body contact side of the shell is in touch with the respective body part to support it during the medical treatment. The patterned surface provides better positioning of the patient.

A second aspect of the invention refers to a further embodiment of the body supporting device for supporting a body part on a treatment board during a medical treatment, comprising a shell adapted to receive the body part and a support frame at least partially surrounding the shell and connectable to the treatment board.

A body contact side of the shell is a replicate of the surface shape of the respective body part manufactured by means of generating 3D image data from a scan of the respective body part and subsequently producing the shell from the 3D image data by additive manufacturing. In the intended use of the device, the body contact side of the shell is in touch with the respective body part to support it on the treatment board during the medical treatment.

In a further advantageous embodiment according to the second aspect of the invention, a body contact side of the shell comprises a structured surface, in particular a regular structure pattern.

In a further advantageous embodiment of the first or second aspect, the structured surface is an in particular regular pattern of indentations, in particular, wherein the indentations are dimples and/or through holes, in particular, wherein the axes of the dimples and/or through holes are parallel, very particular, wherein each dimple and/or hole has a diameter d > 6mm. A third aspect refers to a body supporting device for supporting a body part during a medical treatment, in particular a cancer treatment, comprising a shell adapted to receive the body part. The body contact side of the shell is a replica of the surface shape of the respective body part manufactured by means of generating 3D image data from a scan of the respective body part and subsequently produced from the 3D image data by additive manufacturing. The shell has an extended central opening to form what is referred to herein as an “open shell”, in particular a body contact side of the shell comprises an extended central opening of a size adapted to let look through a part of the body part subject to irradiation treatment. For example if the body part is a female breast, the extended central opening is arranged at the location where the nipple is, such that not only the nipple but also a part of the breast project through the extended central opening below the body supporting device.

Advantageously, a body contact side of the shell comprises a structured surface, in particular a regular structure pattern. In the intended use of the device, the body contact side of the shell is in touch with the respective body part to support it during the medical treatment.

Advantageously, the body supporting device comprises not only said central opening but also a support arch to immobilize the body and help to find the right position.

Advantageously, the body supporting device is constructed to be skin touching. Only by touching the skin, the patient might arrange into the correct reproducible position for the treatment.

Further advantageously, the body supporting device helps to keep the shape of the body part. Therefore, reproducible treatment is possible.

In a further advantageous embodiment of the body supporting device, the device comprises a lash that goes over the extended central opening to stabilize the part of the body part that projects out of the extended central opening.

Further advantageously, the open shell comprises a positioning lash arranged such that it crosses the extended central opening, to support the body part projecting through the central opening. The positioning lash helps to position the body part that projects through the central opening. The positioning lash is preferably removed before the treatment. The positioning lash can also comprise or holds a dosimeter and therefore be used for in vivo dosimetry. The measuring device can be integrated in or act as a support.

The features of the first, second or third aspect of the invention are not limited to the respective first, second or third aspect, but are also disclosed for all aspects of the invention. Features of the first aspect are also disclosed for the second and third aspect and vice versa.

Open shell vs. closed shell: for a shell comprising the extended central opening for parts of the body parts, we call it herein an open shell. Any other shell is called herein a closed shell.

Open Breast Shell is designed for whole breast irradiation (WBI) over several fractions. It is designed to treat the breast (+/- the axillary-mammary lymph nodes) without increasing the dose to the breast skin, which would occur if the shell were in direct contact with the skin. The arc element serves different proposes, the main being helping to position the breast.

Closed Breast Shell is designed for Accelerated Partial Breast Irradiation (APBI) or a single fraction, targeting a small region of the breast where the tumor was or is.

Advantages of the Closed Breast Shell:

• Precise millimetric positioning allows for increased radiation dosage during APBI or a single fraction, improving organ-at-risk and healthy tissue sparing.

• Maintains breast position without stretching.

• MRI compatibility enables imaging in the treatment position, enhancing target definition using MRI images.

• Suitable for PET-CT imaging for target delineation.

• If made of ABS (Acrylonitrile Butadiene Styrene) or polyamide, it can be used with all X- ray beam energies, electrons, and light particles, and ABS is recyclable.

• Eliminates the need for permanent skin tattoos on the breast; the shell serves as a spatial reference for patient positioning.

• Covers most of the breast, enhancing patient dignity and modesty.

• Increases comfort.

• Allows for self-positioning.

• Can serve as a holder for in-vivo skin radiation measuring devices.

• Can be extended to shape/included the contralateral breast. Disadvantages of the Closed Breast Shell:

• Increased skin dose where radiation passes through the shell in contact with the X-ray beam. This is mitigated by the small region of skin receiving radiation due to the limited partial breast area being treated.

• The shell may become tight if the breast swells. This is usually not a concern in APBI, as swelling rarely occurs during the short treatment course (typically delivered within a week). For single-fraction or few fractions treatments, it is not a concern.

Advantages of the Open breast Shell:

• Helps replicate the pre-planned body and breast position during each treatment session.

• The positioning arch facilitates breast positioning and can be removed before treatment.

• The positioning arch can serve as a holder for in-vivo skin radiation measuring devices if left in place.

• MRI compatibility enables imaging in the treatment position, allowing for superior target definition using MRI images.

• Can be used for PET-CT imaging for target delineation.

• The shell does not cover the treated breast, reducing skin dose compared to the supine position.

• If made of ABS (Acrylonitrile Butadiene Styrene), it can be used with all X-ray beam energies, electrons, and light particles, and ABS is recyclable.

• Swelling and redness of the breast skin do not affect the use of the shell because the area susceptible to these issues is not in contact with the shell but falls within the open portion.

• Increases comfort.

• Allows for self-positioning.

• Can enable the treatment of lymph nodes.

• Can be extended to shape/include the contralateral breast.

Disadvantages of the Open breast Shell:

• The breast may stretch, so it is recommended to wait several seconds to allow the breast to assume its stretched form before considering the patient positioned and ready for treatment. This may be more of an issue for elderly individuals with less elastic skin and naturally pendulous breasts.

When performing an MRI or PET-CT without the shell around the breast, it is essential to ensure that the breast is not deformed by contact with an external element.

Further advantageous embodiments of the first, second and third aspect are disclosed:

Advantageously, the body supporting device comprises alignment windows that are arranged such that they correspond to natural marks on the body part.

In a further advantageous embodiment of the invention, the shell comprises at least one pressure release aperture, wherein in the intended use of the body supporting device, the at least one pressure release aperture is adapted to release pressure on a section of the body part.

In a further advantageous embodiment of the invention the support frame comprises vertical support walls arranged at least partially along an outer border of the shell.

In a further advantageous embodiment of the invention, the support frame comprises a lateral treatment opening adapted to let pass a beam for radiation treatment. Advantageously, wherein the lateral treatment opening is arranged such that in the intended use of the body supporting device the lateral treatment opening let pass a beam that is directed lateral or oblique in respect to the treatment board. “Lateral” means lateral to a potential position of the patient positioned on the treatment board.

In a further advantageous embodiment of the invention, the support frame further comprises a support arch attached to a board mounting base of the support frame, wherein in the intended use of the body supporting device, the support arch is adapted to support the body part in lateral direction to the treatment board.

In a further advantageous embodiment of the invention, the support arch comprises at least one pedestal arch, wherein the pedestal arch is connectable to the treatment board. In the intended use of the immobilization device for immobilizing the body part, the pedestal arch connects the support arch to the treatment board and transfers transverse forces acting on the support arch to the treatment board.

In a further advantageous embodiment of the invention, the support frame comprises a body support extension which provides an extension of the support frame, wherein in the intended use of the immobilization device, the body support extension is adapted to receive body parts (e.g. a patient’s armpit and portion of arm) that are not exposed to the medical treatment, or that may serve for complementary treatment. In effect, the extension may also be used for complementary radiation treatment of lymph nodes if the patient is diagnosed with a presence or risk of cancer in the lymph node associated to breast cancer.

In a further advantageous embodiment of the invention, the shell is adapted to receive a breast and an axilla.

In a further advantageous embodiment of the invention, the edges of the shell and/or the support walls are rounded.

A fourth aspect of the invention refers to a set comprising the body supporting device according to the first or second aspect and the treatment board.

A fifth aspect of the invention refers to a Computer-readable medium storing data which defines both a digital representation of the body supporting device or parts thereof according to a first or second aspect of the invention and operating instructions adapted to control an additive manufactured device to fabricate the body supporting device using the digital representation of the body supporting device when said data is relayed to the additive manufactured device.

A sixth aspect of the invention refers to a computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps of a method according to the third aspect.

Other advantageous features of the invention will be apparent from the annexed drawings and the detailed description of embodiments of the invention below.

Brief Description of the Drawings

Figure 1 illustrates an embodiment of the body supporting device according to a first or second aspect of the invention. The body contact side of the device is a body supporting device 100 is a replica of the surface shape of the respective body part manufactured by means of generating 3D image data from a scan of the respective body part and subsequently producing the shell from the 3D image data by additive manufacturing. A body contact side of the shell comprises a structured surface, in particular a regular structure pattern. In the intended use of the device, the body contact side of the shell is in touch with the respective body part to support it during the medical treatment;

Figure 2 illustrates an embodiment a support frame of a body supporting device according to an embodiment of the invention, in particular Fig. 2 shows the support frame for an embodiment of the body supporting device according to a second aspect of the invention. The further embodiment of the body supporting device comprises a shell adapted to receive the body part and the support frame that surrounds the shell at least partially and that is connectable to the treatment board 102, as shown in Fig. 3;

Figure 3a is a photograph of an experimental setup and figure 3b a corresponding line drawing illustrating a treatment board with the body supporting device and the supporting frame. Figures 3a, 3b shows how the support frame is adapted to fit a radiation access orifice for the body part in the treatment board. A body contact side of the shell is a replicate of the surface shape of the respective body part manufactured by means of generating 3D image data from a scan of the respective body part and subsequently producing the shell from the 3D image data by additive manufacturing, wherein in the intended use of the device, the body contact side of the shell is in touch with the respective body part to support it on the treatment board during the medical treatment;

Figure 4a illustrates another view of an embodiment of a body supporting device. In particular figure 4a shows a further embodiment of the body supporting device with alignment window holes of diameter d > 6mm;

Figure 4b illustrates another view of an embodiment of a body supporting device. In particular figure 4b shows a further embodiment of the body supporting device with a pressure release aperture;

Figure 5 illustrates an embodiment of a body supporting device mounted to a treatment board with a supporting frame. In particular Fig. 5 shows a further embodiment of the treatment board comprising the body supporting device mounted with a supporting frame to the treatment board;

Figure 6 illustrates an embodiment of the method to manufacture a body supporting device as well as the body supporting device with a patient lying on the treatment table in a treatment position. In particular, Figure 6a shows a body part of the patient, Figure 6b shows the body part aligned in the body supporting device, and Figure 6c shows the body supporting device arranged on the treatment board;

Figure 7 and Figure 8 illustrate different views of an embodiment of a body supporting device that has an open shell. In particular, figure 7 and figure 8 illustrate the body supporting device with an open shell where a part of the body part might look through the extended central opening. A lash can be added over the extended central opening to support the body part that looks through the central opening;

Figure 9a is a photograph of an experimental setup and figure 9b a corresponding line drawing illustrating an embodiment of a treatment board comprising an embodiment of a body supporting device mounted to the treatment board. In particular figures 9a, 9b illustrate the treatment board with the body supporting device with an open shell according to an embodiment of the invention where a support arch is visible. The function of the arch is to align the body part, respective to immobilize the body part;

Figures 10a and 10b illustrate an embodiment of a body supporting device with a support arch. In particular figures 10a, 10b illustrate an embodiment of an open shell that is manufactured by additive manufacturing according to a method of the invention, the open shell comprising a breast positioning lash including connectors in an attached position (Fig. 10a) and a detached position (Fig. 10b). Both the shell and the lash are personalized for a specific patient;

Figures I la and 11b illustrate schematics of a treatment of a patient’s breast with a closed shell (Figure I la) and an open shell (Figure 11b) according to embodiments of the invention. The closed shell is designed for Accelerated Partial Breast Irradiation (APBI) or Single fraction, treating just a small region of the breast where the tumor is or was. Open shell is designed for whole breast irradiation (WBI) on several fractions. It is designed to treat the breast (+/- the axillary-mammary lymphnodes) without breast skin dose increase which would be present with the shell in contact with the skin.

Detailed description of embodiments of the invention

Referring to the figures a radiation treatment system according to embodiments of the invention comprises a treatment board 102 and a body supporting device 101 configured for removable coupling to the treatment board 102. The treatment board 102 comprises a radiation access orifice 103 in which the body supporting device 101 is configured to be positioned. The treatment board 102 is adapted for receiving a patient thereon, the radiation access orifice being positioned under a body part of the patient that is subject to treatment. In the illustrated embodiments, the body part subject to radiation treatment is a breast, in particular of a person suffering from breast cancer. The treatment board 102 may have a configurable radiation access orifice in particular for opening the treatment board on a left side or a right side depending on whether the body part of the patient is on the right side or on the left side.

More generally, the invention can be applied to other body parts requiring radiation treatment

SUBSTITUTE SHEET (RULE 26) and that may be accessed through an orifice in a treatment board, such parts requiring accurate positioning and support. Body parts that require accurate position and support for treatment could include for instance a patient’s head, limb, or abdomen. Embodiments of the invention are particularly well adapted for treatment of a patient’s breast which in view of the soft tissue

SUBSTITUTE SHEET (RULE 26) requires well adapted devices for positioning and support during treatment.

The body supporting device comprises a shell 2 and a support frame 4. The shell 2 is configured for receiving therein and thereagainst a body part intended for treatment, and the support frame 4 is configured for mounting and securing the body supporting device to the treatment board 102 and in particular to position the body supporting device to the border of the radiation access orifice 103.

In an embodiment, the shell 2 and support frame 4 may be integrally formed as a continuous single part, for instance manufactured by additive manufacturing techniques in a polymer material such as Acrylonitrile Butadiene Styrene or Polyamide

The selected material for at least the shell portion through which the radiation treatment is intended to be administered, has a high transparency to the radiation treatment beam as well as to imaging systems such as magnetic resonance imaging that may be applied before or during the radiation treatment operation.

In variants, it is possible to provide the shell and support frame as separate parts and further to provide the shell and/or support frame in multi-parts that are assembled together in a final position by bonding, mechanical fixing, or welding.

The shell 2 and support frame 4 may be made of a single material or may be made of a plurality of materials, for instance the shell could be provided with areas that are transparent to treatment and/or transparent to imaging and other areas that are opaque to the treatment radiation and/or to the imaging. In case of a situation where the shell has portions that are opaque to the radiation beam , the shell may be configured to provide precisely dimensioned radiation transparent windows through which radiation treatment may be applied. With regards to imaging, certain areas or reference markings may be provided as opaque features on the shell to provide reference points to improve the accuracy of imaging and the targeting of radiation.

Such different materials may be applied during an additive manufacturing process or by subsequent coating or other layering technologies on the shell structure once formed.

The shell 2 has a body contact side 6 that has a shape personalized to the specific body part of a patient to be treated. The shape of the body part to be treated may be captured during an imaging process with the patient lying on the treatment board 102 in the expected treatment position. The achieved digital representation data of the patient’s body part may be converted into operating instructions to fabricate the body supporting device, or at least the shell 2 thereof. The operating instructions may be transmitted to a 3D printer or other additive manufacturing machine.

Depending on the type of body part and morphology of the patient, various features may be included and geometrically defined for the specific geometry of the body part to be treated as will be explained in more detail further on.

The body contact side 6 of the shell comprises a structured surface 30 with indentations such as dimples or through-holes that provide a frictional grip of the skin of the patient’s body part in contact thereagainst. The frictional grip avoids or reduces movement of the body part relative to the shell in the treatment position.

In a preferred embodiment the structured surface 30 has indentations formed by a plurality of through-holes. The through-holes also have the advantage of reducing the material through which imaging and radiation being treatment occurs as well as providing more comfort, allowing the patient’s skin to breathe, for instance reducing transpiration, and also providing some visual access to the patient’s skin through the through-holes.

Various openings may be provided in the shell. These openings may include alignment windows 12 which are provided to view reference markings on the patient’s skin that should be positioned and visible through the alignment windows 12.

There may further be a central opening 8, 8a, in particular for the treatment of a patient’s breast, through which at least the patient’s nipple projects which forms a main positioning and reference alignment of the body part relative to the shell.

In a closed shell configuration, the central opening 8 is dimensioned to allow substantially only the patient’s nipple to project therethrough.

For an open shell configuration, the central opening is an extended central opening 8a that allows the nipple and a large portion of the patient’s breast to project therethrough, such configuration being better adapted for radiation beam treatment from different angles whereas the closed shell configuration is better adapted for targeted more limited radiation treatment as illustrated in figures I la and 11b.

In variants with an extended central opening 8a, the shell 2 may further comprise a lash 10 that extends across the central opening 8, configured to support and position the body part. The lash 10 may be integrally formed with the shell, however in preferred embodiments it is removably fixable to the shell by means of connectors 32 such that during treatment the lash 10 may be removed. The lash may be provided with a positioning element 34 for receiving a body portion, for instance comprising a body portion receiving cavity 36, which in the case of breast treatment would be for receiving the patient’s nipple therein, thus insuring a correct breast placement relative to the shell.

The openings may further comprise a pressure release aperture 14 adapted to release pressure on a body section. In particular, in the case of a patient with a voluminous breast to be treated, the pressure release aperture 14 allows easier insertion and removal of the patient’s body section into the shell 2. The shell may further comprise an outer border 18 for additional support and positioning of surrounding body sections of the patient for better overall positioning of the patient on the treatment board 102 and with respect to the radiation access orifice 103.

The support frame 4 comprises a board mounting base 20 that is shaped to form a base that lies against a border of the radiation access orifice, for positioning and fixing the body supporting device to the treatment board 102.

The board mounting base 20 may comprise various features or may simply be a flat flange for clamping to the treatment board with various mechanical devices.

In advantageous embodiments, the support frame further comprises a support arch 28 arranged on an open side of the radiation access orifice 103 when the body supporting device is coupled to the treatment board 102. This support arch 28 forms an arched shape beam supported at opposing ends to the board mounting base 20. The support arch 28 may either be integrally formed with the support frame 4 or may be formed as a separate component that is coupled to the board mounting base 20 or alternatively coupled directly to the treatment board 102.

Preferably, the support arch 28 is integrally formed with the shell 2 such that it provides direct structural strength and rigidity to the shell. The support arch provides on the one hand a mechanical support against vertical and lateral forces to support the patient’s weight and pressure applied vertically and laterally, and on the other hand also increases the available space for positioning and directing the radiation treatment and/or imaging system from an outer side of the treatment table where the radiation access orifice 103 and body supporting device 101 is positioned.

The support arch 28 may be in a form of a pedestal arch that is connectable to the treatment board with mechanical means such as screws, clamps, or other per se well known mechanical fixing devices.

Depending on the patient’s morphology, the support frame may comprise various vertical support walls 22 interconnecting edges of the shell 2 to the board mounting base 20 of the support frame 4, thus providing support to the shell and structural rigidity thereto.

The support frame may further include lateral treatment openings 24 in which a portion of the edge of the shell 2 is decoupled from the board mounting base 20 of the support frame. This allows a radiation beam treatment to pass through in a lateral direction through the lateral treatment opening 24 if this is desired in the treatment plan.

The support frame 4 may further comprise a body support extension 26 adapted to receive body parts not exposed to treatment, for instance in the case of breast radiation treatment the body support extension may be configured to support the patient’s axilla and top part of the arm for better stability and positioning of the body section that is intended to be exposed to treatment.

In a variant, the body support extension 26 could also be used for treatment, for instance for lymph node radiation in conjunction with the breast radiation treatment. List of features

Radiation treatment system

Treatment board 102

Radiation access orifice 103

Body supporting device 101

Shell 2

Body contact side 6

Structured surface 30

Regular structure pattern

Indentations

Dimples

Through holes

Central Opening 8

Extended central opening 8a

Lash 10

Connectors 32

Positioning element 34

Body portion receiving cavity 36

Alignment windows 12

Pressure release aperture 14

Lateral treatment opening 16

Outer border 18

Support frame 4

Board mounting base 20

Vertical support walls 22

Lateral treatment opening 24

Body support extension 26

Support arch 28

Pedestal arch (connectable to the treatment board)

Computer-readable medium digital representation data of the body supporting device operating instructions to fabricate the body supporting device

Claims

1. Body supporting device for supporting a body part during a medical treatment, in particular a cancer treatment, comprising a shell adapted to receive the body part wherein a body contact side of the shell is a replica of the surface shape of the respective body part manufactured by means of generating 3D image data from a scan of the respective body part and subsequently produced from the 3D image data by additive manufacturing, wherein the body contact side of the shell comprises a structured surface, in particular a regular structure pattern, wherein in the intended use of the device, the body contact side of the shell is in touch with the respective body part to support it during the medical treatment.

2. Body supporting device for supporting a body part on a treatment board during a medical treatment, comprising a shell adapted to receive the body part, a support frame at least partially surrounding the shell and connectable to the treatment board, wherein the support frame is adapted to fit a recess for the body part in the treatment board, wherein a body contact side of the shell is a replicate of the surface shape of the respective body part manufactured by means of generating 3D image data from a scan of the respective body part and subsequently producing the shell from the 3D image data by additive manufacturing, wherein in the intended use of the device, the body contact side of the shell is in touch with the respective body part to support it on the treatment board during the medical treatment.

3. Body supporting device for supporting a body part on a treatment board during a medical treatment comprising a shell adapted to receive a body part, wherein the body contact side of the shell is a replica of the surface shape of the respective body part manufactured by means of generating 3D image data from a scan of the respective body part and subsequently produced from the 3D image data by additive manufacturing, wherein a body contact side of the shell comprises an opening of a size adapted to let look through a part of the body part, wherein in the intended use of the device, the body contact side of the shell is in touch with the respective body part to support it during the medical treatment.

4. The body supporting device according to claim 2, wherein the body contact side of the shell comprises a structured surface, in particular regular structure pattern.

5. The body supporting device according to claim 1 or 4, wherein the structured surface is an in particular regular pattern of indentations, in particular, wherein the indentations are dimples and/or through holes, in particular, wherein the axes of the dimples and/or through holes are parallel, very particular, wherein each dimple and/or hole has a diameter d >= 6mm.

6. The body supporting device according to one of the preceding claims comprising an opening adapted to let a part of the body part look out.

7. The body supporting device according to one of the preceding claims comprising alignment windows, in particular, wherein in the intended use of the body supporting device the alignment windows are arranged such that they correspond to natural marks on the body part.

8. The body supporting device according to one of the preceding claims, wherein the shell comprises at least one pressure release aperture, wherein in the intended use of the body supporting device, the at least one pressure release aperture is adapted to release pressure on a section of the body part.

9. The body supporting device according to one of the preceding claims, wherein the shell and/or the support frame comprises vertical support walls arranged at least partially along the outer border of the shell.

10. The body supporting device according to one of the preceding claims, wherein the support frame comprises an lateral treatment opening adapted to let pass a beam for radiation treatment, in particular, wherein the lateral treatment opening is arranged such that in the intended use of the body supporting device the lateral treatment opening let pass a beam that is directed lateral or oblique in respect to the treatment board.

11. The body supporting device according to one of the preceding claims, further comprising a support arch attached to the support frame, wherein in the intended use of the body supporting device, the support arch is adapted to support the body part in lateral direction to the treatment board.

12. The body supporting device according to claim 11, wherein the support arch comprises at least one pedestal arch, wherein the pedestal arch is connectable to the treatment board, wherein in the intended use of the immobilization device for immobilizing the body part, the pedestal arch connects the support arch to the treatment board and transfers transverse forces acting on 17 the support arch to the treatment board.

13. The body supporting device according to one of the preceding claims, wherein the support frame comprises a body support extension which is a deformation of the support frame, wherein in the intended use of the immobilization device, the body support extension is adapted to receive body parts that are not exposed to the medical treatment.

14. The body supporting device according to one of the preceding claims wherein the shell is adapted to receive a breast and an axilla.

15. Method for manufacturing a body supporting device for supporting a body part on a treatment board during a medical treatment, wherein the device comprises: a shell adapted to receive the body part, and a support frame at least partially surrounding the shell and connectable to the treatment board, wherein the method comprises the steps of manufacturing the shell that is a replicate of the surface shape of the respective body part by generating 3D image data by scanning the body part, producing the shell from the 3D image data by additive manufacturing.

16. Set comprising the body supporting device according to one of the preceding claims 1 to 14 and a treatment board.

17. Computer-readable medium storing data which defines both a digital representation of the body supporting device or parts thereof according to claim 1 to 14 and operating instructions adapted to control an additive manufactured device to fabricate the body supporting device using the digital representation of the body supporting device when said data is relayed to the additive manufactured device.

18. Computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps of a method according to claim 15.

19. A body supporting device (101) for mounting on a treatment board (102) of a radiation treatment system (100), the treatment board configured for receiving a patient thereon and having a radiation access orifice (103) in which the body supporting device (101) is configured to be removably mounted, the body supporting device comprising a shell (2) and a support frame (4) coupled to the shell, the support frame including a board mounting base (20) 18 configured to be mounted against a border of the radiation access orifice of the treatment board, the shell comprising a body contact side (6) having a structured surface (30) configured for receiving a patient’s body section thereagainst, the structured surface (30) including indentations formed by dimples or through-holes.

20. The body supporting device of the preceding claim wherein the support frame comprises a support arch (28) arranged on an outer side of the shell adjacent an outer side of the treatment board when the shell is installed on the treatment board.

21. A body supporting device (101) for mounting on a treatment board (102) of a radiation treatment system (100), the treatment board configured for receiving a patient thereon and having a radiation access orifice (103) in which the body supporting device (101) is configured to be removably mounted, the body supporting device comprising a shell (2) and a support frame (4) coupled to the shell, the support frame including a board mounting base (20) configured to be mounted against a border of the radiation access orifice of the treatment board, wherein the support frame comprises a support arch (28) arranged on an outer side of the shell adjacent an outer side of the treatment board when the shell is installed on the treatment board.

22. The body supporting device of either of the two directly preceding claims wherein the support arch is integrally formed with the board mounting base, or is formed as a separate part assembled to the mounting base, or configured to be directly fixed on the treatment table.

23. The body supporting device of any of the three directly preceding claims wherein the support arch is adapted to span substantially across a whole length of the radiation access orifice (103).

24. The body supporting device of any of claims 19 to 23 wherein the support frame further comprises a body support extension (26) adapted to receive a body part not exposed to treatment.

25. The body supporting device according to any preceding claim 19 to 24 wherein the shell comprises one or more openings.

26. The body supporting device of the preceding claim wherein the openings include any one or more of:

RECTIFIED SHEET (RULE 91 ) ISA/EP 19

- a central opening (8) or an extended central opening (8a) configured for projection of a body part therethrough,

- one or more alignment windows (12) configured for viewing reference positions of a patient’s skin,

- one or more pressure release apertures (14) adapted to release pressure of a body section mounted within the body contact side (6) of the shell.

27. The body supporting device according to the preceding claim wherein the central opening is an extended central opening (8a), the shell further comprising a lash (10) spanning across the extended central opening (8a) configured to support or position a body section projecting through the extended central opening (8a).

28. The body supporting device of the preceding claim wherein the lash comprises a position element configured to engage an element of a body section for positioning thereof relative to the shell.

29. The body supporting device of the preceding claim wherein the positioning element (34) is a body portion receiving cavity (36).

30. The body supporting device of claims 19 to 29 wherein the shell comprises a lateral treatment opening (24) between the shell and support frame for lateral radiation treatment of the body section intended to be treated.

31. The body supporting device of any preceding claim 19 to 30 wherein the support frame includes vertical support walls (22) interconnecting the board mounting base (20) to edges of the shell.

32. The body supporting device of any preceding claim 19 to 31 wherein the shell and the support frame are integrally formed as a single component by additive manufacturing.

33. The body supporting device of any preceding claim 19 to 32 wherein the shell (2) comprises a shape produced from a digital representation data of a body section of a patient to be treated by additive manufacturing.

34. A radiation treatment system including a body supporting device (101) according to any 20 preceding claim 19 to 33 and a treatment board (102) comprising a radiation access orifice (103) configured to receive the body supporting device therein with the shell (2) accessible from an underside of the treatment board for radiation treatment.