Endorectal probe device for effecting radiation treatment of colorectal cancerous tissue in the rectum of a human or animal subject

Abstract

The invention relates to the radiation treatment of colorectal cancerous tissue in the rectum of a human or animal subject. In particular the invention relates to an endorectal probe device for effecting radiation treatment of colorectal cancerous tissue in the rectum of a human or animal subject. Furthermore the invention relates to an afterloading apparatus for effecting radiation treatment of colorectal cancerous tissue in the rectum of a human or animal subject using an endorectal probe device according to the invention. Moreover the invention relates to a method for effecting radiation treatment of colorectal cancerous tissue in the rectum of a human or animal subject, wherein the method implements the endorectal probe device according to the invention.

Claims

1. An endorectal probe device for effecting radiation treatment of colorectal cancerous tissue in a rectum of a human or animal subject, the endorectal probe device comprising: an endorectal catheter probe having an elongated body with a distal probe end and a proximal probe end, which endorectal catheter probe being arranged to be inserted with its proximal probe end within the rectum towards the colorectal cancerous tissue in the rectum; the elongated body of the endorectal catheter probe having at least one longitudinal catheter bore extending from the distal probe end towards the proximal probe end, the at least one longitudinal catheter bore being arranged in guiding an energy emitting source towards the colorectal cancerous tissue for delivering a certain preplanned amount of radiation energy at one or more pre-determined dwell positions near or at the colorectal cancerous tissue; and an endorectal tube having a hollow elongated body with a distal tube end and a proximal tube end, the proximal tube end of the hollow elongated body having an opening and adapted to be arranged within the rectum and against the colorectal cancerous tissue in the rectum, and the hollow elongated body being arranged in movable accommodating the endorectal catheter probe, such that the endorectal catheter probe is positioned with its proximal probe end against the colorectal cancerous tissue, wherein the endorectal catheter probe comprises a radiation shielding disk disposed adjacent to the proximal probe end configured to shield radiation in a longitudinal distal direction.

2. The endorectal probe device according to claim 1, wherein the catheter probe is movable in at least a longitudinal direction within the endorectal tube.

3. The endorectal probe device according to claim 1, wherein the proximal probe end of the endorectal catheter probe is closed.

4. The endorectal probe device according to claim 3, wherein an end face of the closed proximal probe end of the endorectal catheter probe consists of at least one flat surface, wherein the at least one flat surface of the closed proximal probe end exhibits an inclined orientation relative to a longitudinal direction of the endorectal catheter probe.

5. The endorectal probe device according to claim 3, wherein an end face of the closed proximal probe end of the endorectal catheter probe consists of a convex surface.

6. The endorectal probe device according to claim 3, wherein an end face of the closed proximal probe end of the endorectal catheter probe consists of at least one flat surface, wherein the at least one flat surface of the closed proximal probe end exhibits a perpendicular orientation relative to the longitudinal direction of the endorectal catheter probe.

7. The endorectal probe device according to claim 1, wherein the elongated body of the endorectal catheter probe comprises multiple longitudinal catheter bores.

8. The endorectal probe device according to claim 7, wherein the multiple longitudinal catheter bores are arranged in an equidistant manner around a central axis of the elongated body in a circle wise manner.

9. The endorectal probe device according to claim 1, wherein the endorectal catheter probe is transparent to visible light and the radiation used for effecting the radiation treatment.

10. The endorectal probe device according to claim 1, wherein the proximal tube end and/or the proximal probe end is at least partly opaque to the radiation used for effecting the radiation treatment.

11. The endorectal probe device according to claim 1, wherein at least the endorectal tube is made of a rigid material.

12. The endorectal probe device according to claim 1, wherein the elongated body of the endorectal tube has a straight orientation.

13. The endorectal probe device according to claim 1, wherein the endorectal catheter probe is connected with its distal probe end to an afterloading apparatus, and, wherein the energy emitting source is contained in the afterloading apparatus and is arranged to be inserted through at least one longitudinal catheter bore of said endorectal catheter probe towards the one or more pre-determined dwell positions near or at the colorectal cancerous tissue site using a source wire having a proximal end connected to the energy emitting source.

14. The endorectal probe device according to claim 1, wherein the elongated body of the endorectal catheter probe includes a plurality of longitudinal catheter bores extending from the distal probe end towards the proximal probe end.

15. The endorectal probe device according to claim 1, wherein the endorectal catheter probe further comprises a radiation shielding wall coupled to the radiation shielding disk, the radiation shielding wall surrounding the at least one longitudinal catheter bore at the proximal probe end to shield radiation in a radial direction.

16. The endorectal probe device according to claim 1, further comprising a clamping device including a clamp element configured to fixate the endorectal catheter probe and the endorectal tube against unwanted movement.

17. An endorectal probe device for effecting radiation treatment of colorectal cancerous tissue in a rectum of a human or animal subject, the endorectal probe device comprising: an endorectal catheter probe having an elongated body with a distal probe end and a proximal probe end, which endorectal catheter probe being arranged to be inserted with its proximal probe end within the rectum towards the colorectal cancerous tissue in the rectum; the elongated body of the endorectal catheter probe having at least one longitudinal catheter bore extending from the distal probe end towards the proximal probe end, the at least one longitudinal catheter bore being arranged in guiding an energy emitting source towards the colorectal cancerous tissue for delivering a certain preplanned amount of radiation energy at one or more pre-determined dwell positions near or at the colorectal cancerous tissue; and an endorectal tube having a hollow elongated body with a distal tube end and a proximal tube end, the proximal tube end of the hollow elongated body having an opening and adapted to be arranged within the rectum and against the colorectal cancerous tissue in the rectum, and the hollow elongated body being arranged in movable accommodating the endorectal catheter probe, such that the endorectal catheter probe is positioned with its proximal probe end against the colorectal cancerous tissue, wherein the elongated body of the endorectal catheter probe comprises multiple longitudinal catheter bores, and wherein the multiple longitudinal catheter bores extend parallel to each other through the elongated body or wherein near the proximal end of the endorectal catheter probe the multiple longitudinal catheter bores diverge from each other.

18. An endorectal probe device for effecting radiation treatment of colorectal cancerous tissue in a rectum of a human or animal subject, the endorectal probe device comprising: an endorectal catheter probe having an elongated body with a distal probe end and a proximal probe end, which endorectal catheter probe being arranged to be inserted with its proximal probe end within the rectum towards the colorectal cancerous tissue in the rectum; the elongated body of the endorectal catheter probe having at least one longitudinal catheter bore extending from the distal probe end towards the proximal probe end, the at least one longitudinal catheter bore being arranged in guiding an energy emitting source towards the colorectal cancerous tissue for delivering a certain preplanned amount of radiation energy at one or more pre-determined dwell positions near or at the colorectal cancerous tissue; and an endorectal tube having a hollow elongated body with a distal tube end and a proximal tube end, the proximal tube end of the hollow elongated body having an opening and adapted to be arranged within the rectum and against the colorectal cancerous tissue in the rectum, and the hollow elongated body being arranged in movable accommodating the endorectal catheter probe, such that the endorectal catheter probe is positioned with its proximal probe end against the colorectal cancerous tissue, wherein the proximal probe end of the endorectal catheter probe is closed, and wherein an end face of the closed proximal probe end of the endorectal catheter probe consists of a concave surface, or an end face of the closed proximal probe end of the endorectal catheter probe consists of at least one flat surface, wherein the at least one flat surface of the closed proximal probe end exhibits an inclined orientation relative to the longitudinal direction of the endorectal catheter probe.

Description

BRIEF DESCRIPTION OF THE INVENTION

(1) The invention will now be described in more detail with reference to the accompanying drawings, which drawings show in:

(2) FIG. 1 a schematic depiction of a patient being treated with an endorectal probe device according to the invention interconnected to an afterloading apparatus;

(3) FIG. 2 a detailed view of the endorectal probe device according to the invention positioned in the rectum of a patient;

(4) FIG. 3 a clamping device for fixating the endorectal probe device according to the invention relative to the patient;

(5) FIG. 4 a detailed view of an embodiment of an endorectal probe device according to the invention;

(6) FIGS. 5A and 5B further embodiments of an endorectal probe device according to the invention;

(7) FIGS. 6A and 6B further embodiments of an endorectal probe device according to the invention;

(8) FIGS. 7A-7B-7C detailed views of endorectal probe devices according to the invention positioned in the rectum of a patient in dependence of the shape and location of the colorectal cancerous tumor;

(9) FIGS. 8A-8I detailed views of endorectal probe devices according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

(10) For a better understanding of the invention like parts in the drawings are denoted with identical reference numerals.

(11) In the detailed description below as well as in the claims various parts are denoted with the classification “proximal” and “distal”. These classifications are to be considered in relation to the location of the colorectal cancerous tumor to be treated. Hence the classification “proximal” is to be understood as meaning “closest to the tumor to be treated” or “in a direction towards the location of the tumor”. Similarly “distal” is to be understood as meaning “farthest from the tumor to be treated” or “in a direction away from the location of the tumor”.

(12) FIG. 1 shows in very schematic form various elements of a radiation treatment set-up for treating a colorectal cancer tumor inside the rectum of a patient with radiation using an endorectal probe device according to the invention interconnected to an afterloading apparatus.

(13) A patient 1 is shown placed in an all-four position with his/her knees 1a on a treatment table 5, with the torso 1d of the patient 1 being supported by a support rest or support cushion 6. Alternatively the patient 1 rests with his/her torso 1d directly on the knees 1a, resulting in the anal opening 1b being more open for the insertion of the endorectal probe device 10. Fixedly connected to the treatment table 5 is a clamping device 20 for fixedly positioning and orientating an endorectal probe device 10. The endorectal probe device 10 according to the invention is inserted with its proximal device end 10a via the anus 1b into the rectum canal 1c. The endorectal probe device 10 is placed with its proximal device end 10a against a colorectal cancer tumor indicated with reference numeral 2. The colorectal cancer tumor 2 has developed in the rectum tissue wall and is to be treated by internally applying radiation, also called contact .sup.192Ir/gamma/HDR brachytherapy, using the endorectal probe device 10 according to the invention.

(14) It is known in the medical field to use afterloading apparatuses (or afterloaders) for the brachytherapy treatment of cancerous tumors using radioactive sources having an intensity greater than that, which can safely be handled. Remote afterloaders are devices generally used in the cancer treatment field to accurately advance and retract a flexible wire (the source wire) containing an energy emitting source over a specified distance for a specific time period. The energy emitting source is often a gamma radiation emitting source, such as a .sup.192Ir source.

(15) In FIG. 1 the afterloading apparatus 30 is depicted in a very schematic manner, but in general may comprise a base, which is preferably placed on wheels, a pedestal and a head. The head is vertically adjustable with respect to the pedestal by means of an adjustment mechanism. Usually the base or pedestal can be positioned manually in a desired location relative to the patient to be treated.

(16) The head contains a flexible simulation or test (“dummy”) wire for testing purposes and a flexible source wire with the energy emitting source, as well as specific control and transport mechanisms to operate both types of wires, as well as a radiation shielded housing for the radiation emitting source. The radiation shielded housing, in which the radiation emitting source is stored in between treatments, prevents unnecessary exposure of radiation towards the environment, in particularly to medical personal and the patient.

(17) The medical procedure according to the invention initiates with placing the afterloading apparatus 30 near the patient 1 to be treated. Prior to the radiation treatment the endorectal probe device 10 is inserted into the rectum and against the tumor 2 to be treated. The endorectal probe device 10 is interconnected to the afterloading apparatus 30 by means of multiple (flexible) closed catheter tubes 40.sub.1-40.sub.2- . . . -40.sub.n (also indicated as “guide tubes”), each catheter tube 40.sub.1-40.sub.2- . . . -40.sub.n being guided in a corresponding catheter bore 13.sub.1-13.sub.2- . . . -13.sub.n of the endorectal probe device 10.

(18) A typical number n of catheter bores 13.sub.1-13.sub.2- . . . -13.sub.n and thus also the number of corresponding catheter or guide tubes 40.sub.1-40.sub.2- . . . -40.sub.n amounts approx. n=2 till 25, but usually n=5 till 15 depending on the desired radiation treatment as pre-planned.

(19) As explained in more detail with reference to FIGS. 2 and 4 the endorectal probe device 10 is composed of an endorectal tube 11 and an endorectal catheter probe 12. The endorectal tube 11 has a hollow elongated body with an internal hollow dimension, which is more or less conformal (in fact slightly larger than) to the outer dimensions of catheter probe 12. According to the initiating step of the method according to the invention the endorectal tube 11 is inserted with its proximal tube end 11a via the anus 1b into the rectum 1c towards and against or around the cancerous tumor 2 in the rectum wall to be treated. Due to the length of the endorectal tube 11, it's distal tube end 11b is exposed and sticks outside the patient's rectum 1b.

(20) Due to the hollow configuration of the endorectal tube 11 as well as the transparent material of which the tube 11 is made, in a next method step according to the invention a visual check to be performed by the medical personnel is possible in order to ascertain the correct position of the proximal tube end 11a relative to the cancerous tumor 2 to be treated. According to a further step of the treatment method according to the invention a repositioning of the proximal tube end 11a is possible until the proximal tube end 11a is properly placed against or more preferably around the cancerous tumor 2. After the visualizing step and if necessary the repositioning step according to the invention, in a subsequent step the distal tube end 11b of the endorectal tube 11 is then fixated relative to the patient 1 and the treatment table 5 by means of the clamping device 20 (explained further).

(21) In a subsequent step, the catheter probe 12 is then slid with its proximal catheter probe end 12a in longitudinal direction in the hollow endorectal tube 11. Due to the proper orientation and alignment of the endorectal tube 11 relative to the cancerous tumor 2, also the catheter probe 12 is properly aligned, in particular as the outer dimensions of the catheter probe 12 are more or less conformal to the inner dimensions of the hollow endorectal tube 11. As such no play exists between both probe device elements 11 and 12 and the proximal catheter probe end 12a abuts or comes in direct contact with the tumor 2 to be treated.

(22) Likewise the distal catheter probe end 12b is exposed outside the patient's rectum 1b and in a next step, the distal catheter probe end 12b is fixated by the clamping device 20 against undesired movements, and misalignments, which might adversely affect the radiation treatment to be performed.

(23) Following the fixating of the endorectal probe device 10 (the assembly of the endorectal tube 11 and the endorectal catheter probe 12) relative to the patient 1 and the treatment table 5 the guide tubes 40.sub.1-40.sub.2- . . . -40.sub.n are connected to the source wire opening (or a multiple of source wire openings) of the afterloading apparatus 30. Prior to the treatment the passage way of each guide tube 40.sub.1-40.sub.2- . . . -40.sub.n until within the catheter bores 13.sub.1-13.sub.2- . . . -13.sub.n is checked (“cleared”) using the test (“dummy”) wire (not shown), which is advanced and retracted from and thru the (head of the) afterloading apparatus into each guide tube 40.sub.1-40.sub.2- . . . -40.sub.n.

(24) Once it has been ascertained that all guide tubes 40.sub.1-40.sub.2- . . . -40.sub.n are clear and unblocked, the source wire drive means (not shown) present in the (head of the) afterloading apparatus 30 are activated for advancing the source wire (reference numeral 51 in FIG. 2) together with the energy (radiation) emitting source 50 (see also FIG. 2) through an internal guidance path within the afterloading apparatus 30, through the source wire opening and through one of the guide tubes 40.sub.1-40.sub.2- . . . -40.sub.n connected to this source wire opening until into the corresponding catheter bore 13.sub.1-13.sub.2- . . . -13.sub.n in the endorectal probe device towards an pre-determined position (the dwell position) within the relevant catheter bore near the tumor 2 to be treated.

(25) Subsequently the radiation source 50 delivers a therapeutic, predetermined dose of radiation to the tumor during specific pre-planned periods of time (the dwell time). See also FIG. 2. The radiation is emitted towards the tumor under the principals of radioactive decay of radioactive material. After the radiation treatment the source wire drive means retract the source wire 51 together with the radiation source 50 back through the guide tube 40.sub.1-40.sub.2- . . . -40.sub.n into the (head of the) afterloading apparatus 30.

(26) Subsequently the source wire 51 can be advanced through another guide tube 40.sub.1-40.sub.2- . . . -40.sub.n towards a different catheter bore 13.sub.1-13.sub.2- . . . -13.sub.n and towards a subsequent different dwell position (or several dwell positions within the same catheter bore) near or against the tumor to be treated. Thus dependent on the necessary pre-planned radiation treatment it is possible to perform multiple treatment sessions with the same radioactive source at multiple, different treatment (dwell) positions within the rectum 1c of the patient 1.

(27) FIG. 3 depicts an example of a clamping device 20 for use in cooperation with an endorectal probe device 10 according to the invention. The clamping device 20 is composed of a base plate 21 which is to be positioned on the flat surface of the treatment table 5 as shown in FIG. 1. Base plate 21 can be connected to the table 5 using suitable connecting means 21a which can be standardized for general hospital use.

(28) Base plate 21 is provided with a rotating hinge connector 22 which supports a vertical support post 23. The vertical support post 23 is allowed to rotate around its own longitudinal direction and is provided with a first ball hinge 24a. First ball hinge 24a supports a first support bar 25a, which in turn is connected with a second ball hinge 24b. Second ball hinge 24b is subsequently connected to a second support bar 25b to which a support clamp element 26 is mounted.

(29) It will be clear that in another embodiment the clamping device 20 may only comprise the first support bar 25a connected to the first ball hinge 24a, with the support clamp element 26 being mounted to the first support bar 25. Thus in that other embodiment the second ball hinge 24b and second support bar 25b are obviated.

(30) It will be clear that the embodiment of the clamping device as shown in FIG. 3 has more degrees of freedom compared to the embodiment where the second ball hinge 24b and the second support bar 25b are obviated.

(31) In the clamping device 20 as depicted in FIG. 3, the degrees of freedom consists of a rotation movement via rotating hinge connector 22 of the vertical support post 23 around its longitudinal orientation as well as degrees of freedom of the two ball hinges 24a and 24b. As such the support clamp element 26 can be properly positioned relative to the patient (see FIG. 1). Support clamp element 26 clamps (fixates) both the distal tube end 11b and the distal catheter probe end 12b, which are exposed outside the rectum 1c of the patient 1.

(32) In FIG. 2, in combination with FIG. 4, the endorectal probe device 10 consists of two element parts, being the endorectal tube 11 and the endorectal catheter probe 12. The endorectal tube 11 is inserted with its proximal tube end 11a via the anus 1b into the rectum 1c and placed against or around the tumor 2 to be treated.

(33) The endorectal tube 11 is preferably made of a transparent material, in particular a transparent plastic which allows—also due to its hollow configuration—a visual inspection of its position within the rectum 11c with respect to the tumor 2 to be treated. Upon visual inspection by the medical personnel the endorectal tube 11 can be repositioned by manually handling the distal tube end 11b exposed from the anus 1b and by maneuvering the proximal tube end 11a in such manner until the proximal tube end 11a is positioned against and preferably around the cancerous tumor 2 in the rectum tissue wall. Positioning the proximal tube end 11a against and preferably around the cancerous tumor 2 is further improved due to the fact that the hollow endorectal tube 11 is also open at its proximal tube end 11a.

(34) As a proper visual inspection of the proximal tube end 11a relative to the cancerous tumor 2 can also be established by means of the hollow feature of the endorectal tube 11, the endorectal tube 11 can also be made from a non-transparent material, in particular from a metal material. The use of a metal material provides rigidity and stability of the endorectal probe device 10 during the radiation treatment, the metal material also provides a shielding against radiation emitted in undesired directions towards healthy tissue regions.

(35) As the proper orientation of the endorectal tube 11 relative to the cancerous tumor 2 is ascertained, the endorectal tube 11 is fixated using the clamping device 20 (see FIG. 3) by coupling the exposed distal tube end 11b with the support clamp element 26 and subsequently locking the respective vertical hinge connector 22 and the first and second ball hinges 24a and 24b, thus preventing any unwanted displacement and reorientation of the endorectal tube 11 with respect to the cancerous tumor 2.

(36) Catheter probe 12 is subsequently inserted with its proximal catheter probe end 12a via the fixated distal tube end 11b into the hollow endorectal tube 11 towards the cancerous tumor 2. As the proximal tube end 11a is properly placed against and preferably around the cancerous tumor 2 likewise the proximal catheter probe end 12a of the catheter probe 12 will abut against the tumor 2. Unlike the open proximal tube end 11a, the proximal catheter probe end 12a is closed and as such the closed proximal probe end face 120a abuts and contacts the cancerous tumor 2 in a direct manner.

(37) The catheter probe 12 is provided with multiple catheter bores 13.sub.1-13.sub.2-, . . . -13.sub.n which catheter bores extend in longitudinal orientation, one of these catheter bores coinciding with the longitudinal axis 12′ (central catheter bore 130). As clearly shown in FIGS. 5A-5B and 6A-6B the number n of catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n can be 2 till 25 and preferably 5 till 15. The plurality of n catheter bores can be arranged in an equidistant manner around the central axis 12′ (see FIG. 4, FIGS. 5A-5B and FIGS. 6A-6B) of the elongated body 12 and in particular in a circle wise manner. In particular the plurality of longitudinal catheter bores 13.sub.1-13.sub.2- . . . -13.sub.n can be arranged in a first group in a circle close to the outer periphery 12c of the elongated body 12. See FIGS. 5A and 5B.

(38) Also a further, second group of longitudinal catheter bores can be arranged in a circle, which is concentric to the circle formed by the first group of catheter bores. Such configuration is for example disclosed in the embodiments depicted in FIGS. 6A and 6B. Likewise the catheter probe 12 can be provided with a central catheter bore 130 with which coincides with the longitudinal axis 12′ of the elongated body 12. See FIGS. 5A-5B and 6A-6B.

(39) FIG. 4 shows the cross section of the endorectal probe device 10 depicting the hollow endorectal tube 11 and the endorectal catheter probe 12 placed within the endorectal tube 11. It is observed that the inner dimensions of the open, hollow endorectal tube 11 are slightly larger than the outer dimensions of the solid elongated catheter probe 12. As such no or a limited amount of play is present between the endorectal tube 11 and the endorectal catheter probe 12.

(40) Only for the sake of clarity two catheter bores 13 are depicted in FIG. 4. Both catheter bores 13 are positioned at a different radius relative to the longitudinal axis 12′. Unlike the embodiments as shown in FIGS. 5A-5B and 6A-6B the catheter probe 12 as shown in FIG. 4 lacks a central catheter bore 130 coinciding with the longitudinal axis 12′.

(41) For illustration purposes only one of the catheter bores is provided with a catheter or guide tube 40.sub.1-40.sub.2- . . . -40.sub.n, which interconnects the catheter probe 12 (in particular the relevant catheter bore) were the afterloading apparatus (not shown). The catheter or guide tube 40.sub.1-40.sub.2- . . . -40.sub.n fills the relevant catheter bore 13 completely until the closed proximal probe end face 120a and serves as a passage way for a source wire 51 which is provided at its proximal end with an energy emitting source 50. The energy emitting source 50 is preferably a radiation emitting source, such as .sup.192Ir-source.

(42) As the close proximal probe end face 120a is placed against the cancerous tumor (not shown) to be treated, said tumor will be exposed directly with radiation emitted by the energy emitting source 50 positioned within the guide tube 40.sub.1-40.sub.2- . . . -40.sub.n at the dwell position within the catheter bore 13 as shown in FIG. 4. The exposure time or dwell time of the radiation emitting source 50 at the respective dwell position within the catheter bore 13 depends on the radiation treatment to be performed and is pre-calculated by the processing means or dosage planning calculation means of the afterloading apparatus 30.

(43) Such radiation dosage plan is generated prior to the actual radiation treatment and is generated by the dosage plan processing means of the afterloading apparatus according to the invention based on information concerning the patient to be treated, in particular the sex and age of the patient as well as visual image information about the location and size of the tumor to be treated. The dosage plan as calculated also contains information on the overall radiation dose to be emitted, the type of energy emitting source to be used, as well as information on the identification and location of the multiple catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n of the endorectal catheter probe 12 through which the energy emitting source 50 is to be inserted towards to tumor 2 to be treated.

(44) Furthermore the dosage treatment plan as calculated contains information on all the dwell positions for each of the multiple catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n at which the energy emitting source 50 is to be positioned as well as the relevant exposure or dwell time corresponding to each calculated dwell position within each catheter bore.

(45) As such an overall treatment plan is devised based on which the patient (the tumor 2) is properly radiated by the energy emitting source 50, which is subsequently pushed from the afterloading apparatus 30 into each individual catheter bore 130, 13.sub.1-13.sub.2- . . . -13.sub.n and positioned at each pre-calculated dwell position within the respective catheter bore for the corresponding pre-calculated dwell time. The radiation treatment plan thus calculated is executed, until the energy emitting source 50 has been positioned during the corresponding dwell time at all dwell positions in the relevant catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n, such that the calculated overall radiation dose distribution has been delivered to the tumor 2 irradiates the cross section of the tumor to be treated. By repeating the radiation treatment multiple times over a certain period of time, the tumor 2 irradiated multiple times, which will ultimately result in a complete response. Over exposure of healthy tissue to radiation is herewith mostly avoided as the latter side effect is undesired due to health issues.

(46) The endorectal probe device 10 (assembly of the endorectal tube 11 and the endorectal catheter probe 12) has a longitudinal dimension L of preferably 200-250 mm, with an overall diameter X (of the endorectal tube 11) of 22-32 mm (thickness of the hollow endorectal tube wall is approx. 2 mm) whereas the outer diameter D of the endorectal catheter probe 12 amounts 20-30 mm with the inner diameter d of each catheter bore 130, 13.sub.1-13.sub.2- . . . -13.sub.n of 2-3 mm.

(47) Preferably the endorectal catheter probe 12 is transparent to visible light at also for the radiation used for effecting the radiation treatment, and made from a plastic material 120. As such the catheter probe material 120 does not adversely affect the radiation treatment by absorbing the radiation being emitted by the energy emitting source 50. However in order to prevent an undesired exposure of healthy tissue surrounding the cancerous tumor 2 certain parts of the endorectal tube 11 and/or the endorectal catheter probe 12 can be made of a material, which is opaque to the radiation emitted by the energy emitting source 50.

(48) In particular the proximal tube end 11a can contain or can be made from a material which is opaque to the radiation emitted and as such said opaque part of the proximal tube end 11a will absorb the radiation being emitted in a radial direction relative to the longitudinal axis 12′ of the endorectal catheter probe 12. In particular said part of the proximal tube end 11a can contain partly or can be made entirely from a radiation shielding material such as lead or tungsten with a shielding distance or length Q (see FIG. 4) seen in the parallel direction of the longitudinal axis 12′ of approximately 20-25 mm.

(49) As such it is avoided that radiation emitted by the energy emitting source 50 in a radial direction relative to the longitudinal axis 12′ escapes or leaves the endorectal probe device 10 in radial orientation and as such exposure of the healthy rectum tissue directly adjacent to the endorectal probe device 10 is prevented. In fact only radiation emitted in a frontal direction, meaning in the direction of the closed proximal catheter probe end face 120a (parallel to the longitudinal direction of the axis 12′) and in the direction to the cancerous tumor 2 is emitted.

(50) Another embodiment of an endorectal probe device 10 having radiation shielding capabilities is depicted in FIG. 4. In this embodiment the endorectal catheter probe 12 is provided with an insert material 121 manufactured from a radiation shielded material (which is opaque to radiation). In particular the radiation shielding insert material 121 is manufactured e.g. from lead or tungsten and is composed of a concentric radiation shielding insert wall 121a which extends close to the outer circumferential surface 12c of the endorectal catheter probe 12 with a thickness q of approx. 2-5 mm, as well as in a concentric yet parallel direction to the longitudinal axis 12′ over a distance Q of 20-25 mm starting from the closed proximal probe end face 120a towards the distal probe end 12b.

(51) Similarly the radiation shielding insert 121 is provided with an insert part 121b shaped as a disc which extends perpendicular and in radial orientation to the longitudinal axis 12′ across the cross section of the probe 12 and has a thickness P of 10-15 mm (seen in longitudinal direction).

(52) As such the proximal catheter probe end 12a of the catheter probe 12 is provided with a radiation shielding insert 121 surrounding the proximal catheter bore ends 13a of the catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n. An energy emitting source 50 being positioned at a dwell position near the proximal catheter bore end 13a in one of the catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n can only freely emit radiation via the closed yet unshielded against radiation proximal probe end face 120a in the direction of the tumor 2. The proximal catheter probe end 12a is shielded off against radiation emitted in a radial direction (by means of the concentric radiation shielding insert 121a) as well as in the longitudinal distal orientation (by means of the radially extended radiation shielding insert 121b).

(53) Only radiation will be emitted by the energy emitting source 50 in a frontal direction, seen in the longitudinal direction of the catheter probe 12 towards the proximal end 12a thereof and directly towards the tumor 2 which contacts the closed proximal catheter probe end face (or surface) 120a. See also the embodiments of FIGS. 5a-5b and 6a-6b showing similar configurations of radiation shielding inserts 121a and 121b.

(54) The closed proximal catheter probe end face 120a of the catheter probe 12 is preferably flat and perpendicular to the longitudinal axis 12′ as depicted in FIG. 4 as well as in FIGS. 5A and 5B. This allows for a direct, frontal contacting of the tumor 2 with the flat proximal end face 120a of the catheter probe 12. See also FIG. 7A, depicting a flat closed proximal catheter probe end face 120a of the catheter probe 12 directly abutting the tumor 2, which tumor is located directly under the flat rectum wall 1. This flat shaped embodiment of a closed proximal catheter probe end face 120a of the catheter probe 12 is particular suitable in situations where the tumor 2 is located directly under the flat surface of the rectum wall without deforming the surface of the rectum wall.

(55) However, depending on the anatomical orientation of the tumor 2 within the rectum and the associated radiation treatment to be performed the closed proximal catheter probe end face 120a of the catheter probe 12 can also exhibit an inclined orientation relative to the longitudinal axis or direction of the endorectal catheter probe 12. An embodiment wherein the closed proximal catheter probe end face 120a is inclined relative to the longitudinal axis 12′ of the endorectal catheter probe 12 is depicted in FIG. 6A, combined with FIG. 7C in which the endorectal catheter probe 12 exhibits a closed proximal catheter probe end face 120a exhibiting an inclined end face orientation relative to the longitudinal axis. The inclined end face 120a allows for a proper positioning of the endorectal catheter probe 12 against the tumor 2 in situations where the rectum wall also exhibits an inclined tissue surface with respect to the longitudinal axis 12′ of the endorectal catheter probe 12.

(56) FIG. 6B depicts yet another geometry of the closed proximal catheter probe end face 120a of the endorectal catheter probe 12. In this embodiment the closed proximal catheter probe end face 120a of the endorectal catheter probe 12 exhibits a concave surface. This hollow or semi-spherical geometry of the closed proximal catheter probe end face 120a allows for a more accurate positioning of the proximal catheter probe end 12a of the endorectal catheter probe 12 against and around the tumor 2, in particular when the tumor 2 extends or bulges out of the rectum wall. See also FIG. 7B in which the hollow or semi-spherical geometry of the closed proximal catheter probe end face 120a captures and encloses the tumor 2 that in this patient bulges out of the rectum wall 1. The hollow concave geometry of the closed proximal catheter probe end face 120a of the catheter probe 12 insures a proper matching and accommodating of the proximal catheter probe end 12a around and over the tumor 2 and as such guarantees a proper direct frontal radiation of the tumor once the energy emitting source 50 is positioned within one of the catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n near of at the closed catheter probe end surface 120a.

(57) Preferably the plurality of catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n extend parallel to each other throughout the overall longitudinal orientation of the catheter probe 12. These configurations of the catheter bores is for example depicted in FIG. 4, but also in FIG. 5A, and FIG. 6B.

(58) Yet in another configuration the catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n extend parallel to each other over the majority of the longitudinal orientation of the catheter probe 12 but said catheter bores 13.sub.1-13.sub.2- . . . -13.sub.n diverge from each other near the proximal end 12a of the endorectal catheter probe 12. This embodiment is depicted in FIG. 5B where the several catheter bores 13.sub.1-13.sub.2- . . . -13.sub.n extend parallel to each other and close to the central catheter bore 130, but they diverge within the proximal end part 12a which is enclosed by the radiation shielding inserts 121a-121b. It is to be noted that the central catheter probe 130 does not diverge but extends along the longitudinal axis 12′ over the full length of the catheter probe 12.

(59) Furthermore the embodiments of FIGS. 5A-5B depict one group of catheter bores 13.sub.1-13.sub.2- . . . -13.sub.n which are arranged in an equidistance manner around the central axis 12′/the central catheter bore 130 in a circle wise manner close to the outer circumferential surface 12c of the catheter probe 12. The embodiments of FIGS. 6B and 6A depicts two groups of catheter bores 13.sub.1-13.sub.2- . . . -13.sub.n, one group being orientated around the central axis 12′/the central catheter bore 130 in a circle wise manner close to the outer surface 12c, whereas the other group of catheter bores is also arranged in an equidistance circle wise manner around the central bore 130, but inside (concentric to) the circle formed by the outer group of catheter bores.

(60) Preferably the endorectal catheter probe 12 and its configuration of (groups of) plurality of longitudinal catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n is rotational symmetric with respect to its longitudinal central axis 12′. As such its orientation within the endorectal tube 11 is independent. However both the endorectal tube 11 and the endorectal catheter probe 12 can be provided with alignment markings near or at their distal ends 11b and 12b, thus ensuring a correct positioning and orientation of the catheter probe 12 within the endorectal tube 11.

(61) The cylindrical configuration of both the endorectal tube 11 and the endorectal catheter probe 12 also allows to a reorientation of the endorectal catheter probe 12 within the endorectal tube 11 by means of a rotational movement of the endorectal catheter probe 12 around its longitudinal central axis 12′ by means of a manual handling by the medical personnel.

(62) The endorectal catheter probe 12 is preferably manufactured using a 3D printing technique.

(63) Detailed examples of endorectal probe devices according to the invention are depicted in of FIGS. 8A-8H. These embodiments show the several distinct configurations or shapes of the closed proximal catheter probe end face 120a of the proximal catheter probe end 12a of the endorectal catheter probe 12 positioning of against and around the tumor 2.

(64) FIGS. 8A and 8B show two embodiments implementing a flat end face 120a, which is positioned perpendicular to the longitudinal axis 12′ of the catheter probe 12. These embodiments allow for a frontal exposure of the tumor 2 with radiation, by placing the endorectal tube 11 in a frontal orientation directly against and surrounding the tumor 2, and subsequently inserting the endorectal catheter probe 12 inside the already positioned endorectal tube 11, such that the proximal catheter probe end 12a abuts with its flat end face 12 against the tumor 2 for effecting radiation treatment.

(65) FIG. 8C depicts the proximal catheter probe end 12a of an endorectal catheter probe 12 exhibiting a concave surface. This hollow or semi-spherical geometry of the closed proximal catheter probe end face 120a allows for a more accurate positioning of the proximal catheter probe end 12a of the endorectal catheter probe 12 against and around the tumor 2, in particular when the tumor 2 extends or bulges out of the rectum wall.

(66) FIG. 8D depicts a closed proximal catheter probe end face 120a exhibiting an inclined end face orientation relative to the longitudinal axis. The inclined end face 120a allows for a proper positioning of the endorectal catheter probe 12 against the tumor 2 in situations where the rectum wall also exhibits an inclined tissue surface with respect to the longitudinal axis 12′ of the endorectal catheter probe 12.

(67) FIG. 8E depicts the proximal catheter probe end 12a of an endorectal catheter probe 12 exhibiting a convex or outwardly orientated semi-spherical surface. The embodiment of FIG. 8E is a combination of the embodiment of FIG. 8A as the convex end face 120a is positioned perpendicular to the longitudinal axis 12′. Also this embodiment of the endorectal catheter probe 12 allows for a frontal exposure of the tumor 2 with radiation, wherein the tumor 2 is located deeper below the rectum wall or has created an inner bulge in the rectum wall.

(68) FIG. 8F depicts an endorectal catheter probe 12 exhibiting a combination of the inclined end face 120a of FIG. 8D together with a convex or outwardly orientated semi-spherical surface as depicted in FIG. 8E.

(69) FIG. 8G depicts an endorectal catheter probe 12 exhibiting a three-dimensional end face being composed of two inclined end face parts 120a′ and 120a″ which are both inclined with respect to the longitudinal axis 12′ of the probe 12. Furthermore the common boundary line or vertex line 120b is also inclined with respect to the longitudinal axis 12′ allowing for a versatile end face configuration to be used in specific radiation treatments.

(70) Similarly, the embodiment of FIG. 8H depicts an endorectal catheter probe 12 exhibiting an inclined end face 120a which is inclined in two orthogonal directions with respect to the longitudinal axis 12′ of the probe 12 (as compared to the embodiments of FIGS. 6A and 8D whose end faces 120a are inclined in one orthogonal direction with respect to the longitudinal axis 12′ of the probe 12).

(71) An alternative of the embodiment of FIG. 8D is shown in FIG. 8I. The inclined end surface 120a serves for placement against the tumor to be treated and the catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n are positioned closely below and are running parallel to each other and parallel to the closed catheter probe end surface 120a. Herewith an inclined end surface 120a is obtained that can serve entirely as an energy emitting surface as the energy emitting source 50 can be positioned at different locations within the several catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n and closely below the closed catheter probe end surface 120a at a close distance of the tumor to be treated. In the embodiment of FIG. 8I the inclined end surface 120a is shaped as a flat end surface, however in another version the inclined end surface 120a can also be shaped as a convex or outwardly orientated semi-spherical surface.

(72) In all embodiments shown in FIGS. 8A-8I the proximal catheter probe end face 120a can be properly covered by a protective cover 122 for safety issues, which protective cover 122 can be made from a durable plastic material.

(73) It is remarked that all embodiments of the distinct configurations or shapes of the closed proximal catheter probe end face 120a of the catheter probe 12 insure a proper matching and accommodating of the proximal catheter probe end 12a around and over the tumor 2 depending on the physique of the tumor in the rectum of the patient. Depending on the physique of the tumor 2 (size, dimensions, orientation, bulge in or bulge out with respect to the rectum wall) the proper catheter probe shape of configuration can be selected by the physician administering the radiation treatment.

(74) The proper selection of the most effective probe configuration design guarantees a proper direct frontal radiation of the tumor once the energy emitting source 50 is positioned within one of the catheter bores 130, 13.sub.1-13.sub.2- . . . -13.sub.n near of at the closed catheter probe end surface 120a.

(75) In all treatment situations the endorectal tube 11 is placed directly against and around the tumor 2, and subsequently the properly selected endorectal catheter probe 12 is inserted in the positioned endorectal tube 11, such that the proximal catheter probe end 12a abuts with its specifically configured or shaped end face 12 against the tumor 2 for effecting radiation treatment.

REFERENCE NUMERAL LISTING

(76) 1 patient 1a leg/knee 1b anus 1c rectum 1d torso 2 tumor 5 support table 6 support rest or cushion 10 endorectal probe device 10a proximal probe device end 10b distal probe device end 11 endorectal tube 11a proximal tube end 11b distal tube end 12 endorectal catheter probe 12′ longitudinal probe axis 12a proximal catheter probe end 12b distal catheter probe end 12c outer catheter probe surface 12c′ proximal catheter probe end surface 120 catheter probe material 120a-120a′-120a″ closed proximal catheter probe end face 120b vertex line 121 energy shielding insert material 121a concentric shielding wall 121b transverse shielding wall 122 shielding face of proximal catheter probe end surface 13.sub.1-13.sub.2- . . . -13.sub.n longitudinal catheter bore 13a proximal catheter bore end 130 central catheter bore 130a proximal central bore end 20 clamping apparatus 21 support plate 21a connecting means 22 rotating hinge connector 23 vertical support post 24a first ball hinge 24b second ball hinge 25a first support bar 25b second support bar 26 support clamp element 30 afterloading apparatus 40.sub.1-40.sub.2- . . . -40.sub.n catheter/guide tubes 50 energy emitting source 51 source wire