MEDICAL DEVICE FOR RADIOTHERAPY AND METHOD OF MANUFACTURING THE SAME

Abstract

The present relates to 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.

Claims

1. Positioning and shaping shell manufacturing method for manufacturing a positioning and shaping shell comprising: a positioning step including 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 including partially imaging a target body portion surface 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 including producing a 3D positioning and shaping shell model via additive or subtractive manufacturing method based in the processed image data.

2. Positioning and shaping shell manufacturing method according to claim 1, characterized in that the additive manufacturing method is chosen from the group of 3D printing, thermoforming, pin-matrix system shaping and the subtractive manufacturing method is chosen from the group of drilling, milling, turning and laser shaping.

3. Positioning and shaping shell manufacturing method according to claim 1, characterized in that the target body portion is the breast.

4. Positioning and shaping shell manufacturing method according to claim 1, characterized in that the surface scan imaging is selected from the group composed of Magnetic Resonance or Computer Tomography.

5. Patient positioning device for use in a radiotherapy treatment process comprising: a positioning board, and a positioning and shaping shell manufactured by i) 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, ii) at least partially imaging a target body portion surface via the transparent portion of the board and said transparent body support, iii) processing acquired image data in a processing unit, and iv) producing a 3D oositioning and shaping shell model via additive or subtractive manufacturing method based in the processed image data and reproducing a patients target body portion shape and adapted to be installed on the positioning board so as to receive and immobilize said radiotherapy target body portion of the patients body.

6. Patient positioning device according to claim 5, characterized in that the positioning and shaping shell comprises a hollow portion adapted to receive and house a specific bolus.

7. Patient positioning device to claim 5, characterized in that the positioning and shaping shell is made of silicone.

8. Patient positioning device according to claim 5, characterized in that the transparent portion of the board is made of Plexiglas.

9. Patient positioning device according to claim 5, characterized in that it is adapted to position the patient in a prone position.

10. Patient positioning device according to claim 5, characterized in that the positioning board comprises a titling means adapted to tilt and/or move said target body portion.

11. Patient positioning device according to claim 5, characterized in that it further comprises attaching means for attaching the positioning and shaping shell to the positioning board.

12. Patient poisoning device according to claim 5, characterized in that the positioning and shaping shell is adapted to shape the patient's target body portion.

13. Patient positioning device according to claim 5, characterized in that the positioning and shaping shell is made of two complementary detachable elements.

14. Patient positioning device according to claim 5, characterized in that it comprise other devices next to or in contact with the patient with the shapers having alowed to position them as necessary chosen in the group of sensors, monitoring systems, detectors, feeding systems, anesthesia systems, treatment or Imaging systems, cooing or heating systems, tracing systems, gating systems metamatertals and the same.

15. (canceled)

16. Transparent body shaper to be used in the positioning she manufacturing method of claim 1 adapted to support and position a predetermined target body portion in a specific position adapted for an optimal medical treatment.

17. Patient positioning device according to claim 5, characterized in ha it is adapted to at least partially stop a radiotherapy beam and modulate the radiation.

18. Patient positioning device according to claim 5, characterized in that its capacity to immobilize said radiotherapy target body portion of the patient's body includes that it prevents patients body movements during treatments so that the patient's body can be translated/rotated during irradiation while avoiding collisions between the patient and the treatment machine.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Further particular advantages and features of the invention will become more apparent from the following non-limitative description of at least one embodiment of the invention which will refer to the accompanying drawings, wherein

[0039] FIG. 1 is a schematic that illustrates the process of creating a positioning and shaping shell using a surface scanner through a transparent element tilting a head of a patient according to an embodiment of the present invention;

[0040] FIG. 2A to 2C shows the process of producing a positioning and shaping shell for prone breast treatment according to the present invention;

[0041] FIGS. 3A and 3B illustrates an example of a positioning and shaping shell created as a leg support of the present invention;

[0042] FIG. 4A to 4C represent a positioning and shaping shell according to the present invention

DETAILED DESCRIPTION OF THE INVENTION

[0043] The present detailed description is intended to illustrate the invention in a non-limitative manner since any feature of an embodiment may be combined with any other feature of a different embodiment in an advantageous manner.

[0044] In general, a first aspect of the present invention refers to a new positioning and shaping shell manufacturing method including imaging through a transparent portion of a board and produced by additive or subtractive manufacturing using dedicated computer implemented software.

[0045] More particularly, FIG. 1 represents a first aspect of the invention which is a process of using a surface scanner through a transparent element tilting a head of a patient avoiding radiation to the eyes i.e. positioning optimization and creating a positioning and shaping shell for this purpose as well as for patient positioning accuracy, the positioning and shaping shell is available before CT planning and therefore included in the immobilization mask.

[0046] On the other hand, FIGS. 2a to 2c show an alternative process of producing a positioning and shaping shell for prone breast treatment according to another aspect of the present invention. FIG. 2a shows an example of a positioning board with transparent elements, FIG. 2b shows the patient on the positioning board for image via surface scanner and FIG. 2c shows the situation once the positioning and shaping shell has been printed, the patient on the board with the positioning and shaping shell.

[0047] More particularly, these aspects of the invention are specific embodiments of the procedure for manufacturing a patient's body portion positioning and shaping shell comprising a positioning step consisting in positioning and supporting a target body portion of a patient's body with a transparent body shaper in a predetermined position on a positioning board presenting at least one transparent portion permitting scanning through it. In other words, the body shaper allows positioning the body part to image in the optimal position for his future treatment (for imaging treatment or radiotherapy (RT) boluses insert after planning in RT). Then the process comprises an image acquisition step consisting in a target body portion surface scan imaging 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.

[0048] This shell can be used on the patient for CT/MRI image acquisition for radiotherapy RT, bolus insert on the external part of the shell, after CT/MR imaging acquisition for radiotherapy planning is used to determine the bolus characteristics, performing X-ray/MRI/CT image pre- and/or during biopsy, performing X-ray/MRI/CT image for anatomy diagnosis and injection products (for example the injection to replace cartilage), imaging and repeating images to stage the tumor regression progression helping the medical staff to view the body in the same orientation allowing image registration of different imaging modalities example MRI/PET/CT, modifying the body part as needed such as flatten a region for a hyperthermia session which is a long treatment that can last 1-2 hours and allow for image registration of hyperthermia information with planning CT/MRI data and keep the body together and avoid movements when RT treatments allow board movements while the beam is on and reduce patient linac collisions.

[0049] During non-coplanar arc treatments and future treatments with the treatment table moving while irradiating the patient, it will be necessary to assure that no collision is possible between the patient and the treatment machine. Therefore the space around the table and including the patient will need to be modeled in the planning system to avoid collisions. This safe space once defined can be identified prior to the simulated CT by means of transparent walls (curved or linear) that act like body shapers through which the patient's anatomy can be imaged via surface scanners to create positioning shells. This will allow not only to accurately immobilize the patient but also allow the user to know prior CT simulation if the patient's body position is optimal for the treatment foreseen and avoid collisions at treatment.

[0050] This procedure can be useful in several applications including radiotherapy, hyperthermia, biopsy, injections, repeated imaging to verify changes of the investigated area while keeping the body in the same position. It also allows to position bolus.

[0051] Then, FIG. 3a is described which represents an example of a positioning and shaping shell created as a leg support already available at the CT simulation and in which, from the back it is possible to attach a bolus without the need of a new CT scan. FIG. 3b in its turn shows an example of a leg model acquired from a surface scan image prior CT simulation to customize the shaping shell.

[0052] These FIGS. 3a and 3b represent a specific embodiment of a second aspect of the invention which is a positioning device, for use in a radiotherapy treatment process comprising a positioning board, and a silicone or plastic-made positioning and shaping shell reproducing a patient's target body portion shape, preferably comprising a hollow portion adapted to receive and house a specific bolus, and adapted to be installed on the positioning board so as to receive and immobilize said radiotherapy target body portion of the patient's body.

[0053] Although the positing board is not represented, it can comprise a titling means adapted to tilt and/or move the target body portion of the patient's body and attaching means for attaching the positioning and shaping shell to the positioning board.

[0054] On the other hand, the positioning and shaping shell can be made of two complementary detachable elements. In this manner, bolus could be supported/housed even in very complicated shapes of shell. This is explained in more detail below in support of FIGS. 4a to 4c.

[0055] This allows radiotherapy centers to better cure cancer patients, including breast cancer patients, with less side effects. It leads to more accurate and more time-efficient treatments because of better positioning of the patient.

[0056] The device of the present invention allows to better immobilize the target body portion (e.g. the breast or leg or face) using a personalized 3D printed shell. It permits using advanced treatment technique such as protons, and reduce healthy organ irradiation, setup-treatments slot time and imaging radiation.

[0057] In case of breast cancer treatment, the shell of the present invention permits to increase the breast opening on the board also to include the supra-clavicular area, an important region to treat in advanced cancers. it also integrates the use of bolus for superficial tumor treatments.

[0058] Another aspect of the invention relates to the positioning and shaping shell which is a personalized thin hollow support structure acting as a positioning and shaping bolus-support shell, 3D printed with thermoplastic or other materials, using the patient's surface image acquired with a 3D scanner. This positioning and shaping shell is preferably created larger than the region where the foreseen bolus is required and identified using repairs on the patient's skin to determine its location with respect to the patient's body.

[0059] FIGS. 4a to 4c represent a particular embodiment of the positioning and shaping shell which comprises a hollow portion adapted to receive and house a specific bolus, where FIG. 4a shows the bolus shaping shell premade from a surface scan model and ready to be used in combination with immobilizing mask at CT simulation, FIG. 4b shows the two elements that can attach/detach from each other and FIG. 4c shows the presence of the bolus created after CT simulation and planning and hosted in the bolus shaping shell

[0060] The positioning and shaping bolus-support shell preferably has thin physical dimensions and use material or structures that reduce interactions with radiotherapy treatments fields (photons, electrons, protons or others). This is achieved by using hollow or perforated structures.

[0061] Once created the positioning and shaping bolus-support shell is then fitted on the patient prior to any immobilization or positioning and shaping bolus-support shell for CT/MR treatment image acquisition. After radiotherapy simulation and dose planning, the hollow bolus-support structure then hosts the finalized, 3D-printed, optimized bolus by containing or integrating it. In simple cases, a 3D-printed bolus can be placed inside the hollow support structure. In more complicated cases, the upper part of the structure (that can already be attached to an immobilization device) is combined with a lower part of the bolus-support structure. The lower part can be 3D printed using the original's shape, but filled where bolus material is necessary. Very complicated boluses can be created using the flexibility of 3D printers by combining different materials and different filling factors.

[0062] Thanks to this bolus-support structure, it is possible to use an optimal bolus for a specific patient and treatment, without compromising on patient's positioning reproducibility or dose distribution. Also, it permits to use 3D-printed boluses without needing to cut thermo-plastic masks to allow for the fitting of the bolus and thus compromising the mask's rigidity and to improve both patient's comfort and immobilization as the bolus is created on measure from the patient's anatomy creating a perfect fit, even with all accessories necessary to treat the patient (masks, supports, immobilization devices) in place. Finally it permits to avoid pushing on open skin wounds or painful tissue areas to create the bolus and or fit the accessories. The bolus could even avoid contact with damaged skin if supported on healthy skin or fixed to the mask. The use of a hollow bolus-support structure also allows to modify the space around the patients' body surface without the need of new simulation, masks, supports etc and a gain in time and department resources.

[0063] Alternatively one can use a surface optical system that today is used to monitor the patient during treatments (RT align (Vision RT), Optical Surface Monitoring System (Varian Medical system) to acquire patients' body anatomy to create positioning and shaping bolus-support shell using their repairs to allow for positioning the 3D-printed elements on the patients, also prior to treatment.

[0064] One can create for specific areas (such has legs, arms, top of the head etc.) premade sets of different sizes of positioning and shaping bolus-support shells that could be adopted for simulation to speed up the treatment planning process and reduce costs. Such systems should allow sterilization or the use of sterile material between the patient's body and the positioning and shaping bolus-support shell for repeated usage.

[0065] Further advantages of the positioning and shaping shell are listed below: [0066] Position in a reproducible with a body part to treat in the desired position every time; [0067] Allowed to support a bolus in radiotherapy after the bolus position and dimensions are decided following radiotherapy planning (i.e. after CT scan and immobilization tools used); [0068] Made of MRI compatible material it can be used with CT scan and MRI scans on MRI Linacs to improve image registration and do not interfere with a MRI imaging; [0069] It can be used for shaping the body to allow Hyperthermia with using proper shell material such as silicone that interferes only minimally with the heat transfer; [0070] It can be used to interface/support imaging systems, such as echography systems, with the patient body to optimize patients position and accuracy while acquiring images/and or other information

[0071] While the embodiments have been described in conjunction with a number of embodiments, it is evident that many alternatives, modifications and variations would be or are apparent to those of ordinary skill in the applicable arts. Accordingly, this disclosure is intended to embrace all such alternatives, modifications, equivalents and variations that are within the scope of this disclosure. This for example particularly the case regarding the different materials which can be used and the radiotherapy treatment devices which can be used in combination with the present invention.