WO2020091714A1

WO2020091714A1 - Vaginal intensity modulated brachytherapy (imbt) applicator

Info

Publication number: WO2020091714A1
Application number: PCT/TR2019/050900
Authority: WO
Inventors: H. Fadil AKYOL; Fatih BILTEKIN
Original assignee: Hacettepe Universitesi
Priority date: 2018-10-30
Filing date: 2019-10-25
Publication date: 2020-05-07

Abstract

The present invention relates to a brachytherapy (BRT) applicator (1) which enables to perform intensity modulated brachytherapy (IMBT) in gynecologic tumors.

Description

VAGINAL INTENSITY MODULATED BRACHYTHERAPY (IMBT)

APPLICATOR

Technical Field

The present invention relates to a brachy therapy (BRT) applicator which enables to perform intensity modulated brachy therapy (IMBT) in gynecologic tumors.

Background of the Invention

Today, central single-channel applicators are mostly used for vaginal BRT applications. However, in cases where it is required to increase treatment doses or tumor location is asymmetrical or deeper than 5 mm, it is not possible to obtain desired dose distribution around target by central single-channel BRT applicator which is frequently used in conventional methods. In the event that it is requested to increase target coverage, rectum and bladder toxicity based on radiotherapy becomes inevitable. In order to minimize this problem, multi-channel applicators of different designs have been introduced by the manufacturers. However, in the event that tumor size or depth increases or dose increase is requested at a related depth, existing multi-channel applicators lose their advantage and interstitial BRT applications are required. In the event that, tumor location is asymmetrical or its depth is over 1 cm, it is not possible to delivered effective treatment dose by central single-channel and multi channel vaginal applicators. Therefore, interstitial BRT applications requiring interventional procedure are used. In these applications, there is need for applicators which will enable to enhance ease of application and patient comfort by eliminating the invasive procedure required by interstitial BRT in selected patient groups to a large extent in vaginal BRT applications without compromising treatment quality.

The United States patent document no. US2009240095, an application in the state of the art, discloses an applicator used for BRT application and radiation therapy. The applicator helps to minimize the dose received by healthy or normal tissues while delivering the optimum dose to the target area.

The United States patent document no. US2010130807, another application in the state of the art, discloses the advantage of dose distribution to be provided by the multi-channel applicator stated for BRT applications and methods of use thereof. The BRT applicator includes one or more source channels and a movable surface section. The applicator is used by being inserted into the related body cavity or directly into the cavity after the surgical operation or being implanted interventionally thereafter. Therefore, the applicator can be applied in both interstitial and intracavitary BRT methods.

Summary of the Invention

An objective of the present invention is to introduce a BRT applicator which enables to perform IMBT in gynecologic tumors, in particular to vaginal cuff irradiations.

Another objective of the present invention is to introduce a BRT applicator which will enable to perform treatment planning and application with high comfort rate without needing any interventional procedure for some patients requiring interstitial BRT.

Another objective of the present invention is to introduce a BRT applicator which will enable to reduce the doses received by critical organs and to increase the delivered dose to target volume during irradiation of tumors that are deeply located and have asymmetric structure requiring vaginal BRT.

Another objective of the present invention is to introduce a BRT applicator which will enable to keep side effect probabilities in critical tissues around target volume to be the same or less than and to complete treatment in shorter fraction schemes.

Another objective of the present invention is to introduce a BRT applicator which will enable to irradiate different treatment plans successively and to deliver simultaneous additional dose.

Detailed Description of the Invention

“A Vaginal Intensity Modulated Brachytherapy (IMBT) Applicator (1)” introduced to fulfil the objectives of the present invention is shown in the figures attached, in which:

Figure 1 is a sectional view of the inventive BRT applicator parts.

Figure 2 is a three-dimensional view of the inventive BRT applicator parts.

Figure 3 is a general view of the inventive BRT applicator.

The components illustrated in the figures are individually numbered, where the numbers refer to the following:

1. BRT applicator

2. Outer body

21. First guide cavity

3. Inner body

31. Second guide cavity

4. Radiation absorption element 5. Source transfer channel

6. Cap

7. Fixing element

The inventive BRT applicator (1) comprises:

at least one outer body (2) which is fixed to the vaginal cavity in human body;

at least one first guide cavity (21) which is located at the center of the outer body (2);

at least one inner body (3) which is inserted into the outer body (2); at least one second guide cavity (31) which is located at the center of the inner body (3);

at least one radiation absorption element (4) which is inserted into the inner body (3);

at least one source transfer channel (5) which is inserted into the inner body (3);

at least one cap (6) which enables to fix the outer body (2) and the inner body (3) to each other; and

at least one fixing element (7) which enables to fix the outer body (2) externally after it is inserted to the vaginal cavity.

In a preferred embodiment of the invention, the outer body (2) has a cylindrical structure.

In a preferred embodiment of the invention, the outer body (2) is manufactured in various sizes such that it will be suitable for being inserted into the vaginal cavity in human body.

In a preferred embodiment of the invention, the outer body (2) has a cavity that is suitable for inserting the inner body (3) into the outer body (2). In this embodiment of the invention, the outer body (2) has a cylindrical cavity. In a preferred embodiment of the invention, the outer body (2) has a structure such that it will comprise a first guide cavity (21) that is used while proceeding the BRT applicator (1) to the related point in the body at its center, after the inner body (3) is inserted into thereof. In this embodiment of the invention, the first guide cavity (21) has a cylindrical structure.

In a preferred embodiment of the invention, the outer body (2) makes it possible to insert different radiation absorption elements (4) and source transfer channels (5) during same treatment fraction because it is fixed to the vaginal cavity before the inner body (3) is inserted into thereof.

In a preferred embodiment of the invention, the inner body (3) has a structure such that it will be able to fit into the cavity part located in the outer body (2). In this embodiment of the invention, the inner body (3) has a cylindrical structure.

In a preferred embodiment of the invention, the inner body (3) has a size such that it is suitable for entering the outer body (2) and it has cavities wherein at least one radiation absorption element (4) and at least one source transfer channel (5) can be inserted.

In a preferred embodiment of the invention, the inner body (3) has a structure such that it will comprise a second guide cavity (31) that is used while proceeding the BRT applicator (1) to the related point in the body at its center, after the radiation absorption element (4) and at least one source transfer channel (5) are inserted into thereof. In this embodiment of the invention, the second guide cavity (31) has a cylindrical structure.

In a preferred embodiment of the invention, there is at least one channel on the outer wall of the inner body (3). In a preferred embodiment of the invention, the radiation absorption element (4) enables to reduce the dose received by healthy tissues by absorbing the radiation that is emitted from the radioactive source used for tumor treatment.

In a preferred embodiment of the invention, the radiation absorption element (4) is placed in a position that will correspond across the tissue where it is not desired to send radioactive source, into the inner body (3).

In a preferred embodiment of the invention, the radiation absorption element (4) has a structure that is similar to shape of a piece obtained by dividing a cylinder diameter -center of which is empty in a round shape- into four and its every surface is filled.

In a preferred embodiment of the invention, the radiation absorption element (4) has a structure that is similar to shape of a piece obtained by dividing a cylinder diameter -center of which is empty in a round shape- into two, three, five or a desired number and its every surface is filled.

In a preferred embodiment of the invention, the radiation absorption element (4) is modularly attachable and detachable to the inner body (3).

In a preferred embodiment of the invention, it is possible to apply different treatment plans successively due to the fact that the radiation absorption element (4) is modular.

In a preferred embodiment of the invention, the radiation absorption element (4) consists of materials having different densities.

In a preferred embodiment of the invention, the material to be used for production of the radiation absorption element (4) is selected depending on location of critical organs such as rectum and bladder and dose distribution. In a preferred embodiment of the invention, the length of the radiation absorption element (4) is adjusted in accordance with the treatment plan.

In one example of the invention, the radiation absorption element (4) is a material such as lead, titanium, aluminium and Teflon.

In a preferred embodiment of the invention, the source transfer channel (5) has a structure having channels wherein the transfer tubes where the radioactive source will pass are placed.

In a preferred embodiment of the invention, the source transfer channel (5) has suitable dimensions whereby the transfer tubes where the radioactive source will pass can be placed

In a preferred embodiment of the invention, the source transfer channel (5) is placed in a position that will correspond across the tissue where it is desired to send radioactive source, into the inner body (3).

In a preferred embodiment of the invention, the source transfer channel (5) ensures that the radioactive source that will pass through the transfer tubes located inside thereof is sent to the target tissue at desired density.

In a preferred embodiment of the invention, the source transfer channel (5) is modularly attachable and detachable to the inner body (3).

In a preferred embodiment of the invention, it is possible to apply different treatment plans successively due to the fact that the source transfer channel (5) is modular. In a preferred embodiment of the invention, the source transfer channel (5) has a structure that is similar to shape of a piece obtained by dividing a cylinder diameter -center of which is empty in a round shape- into four and at least one channel is located in its inner surface.

In a preferred embodiment of the invention, the source transfer channel (5) has a structure that is similar to shape of a piece obtained by dividing a cylinder diameter -center of which is empty in a round shape- into two, three, five or a desired number and at least one channel is located in its inner surface.

In a preferred embodiment of the invention, part of the source transfer channel (5) at a desired size can be arranged in a filled structure preventing passage of radioactive source.

In a preferred embodiment of the invention, the cap (6) has a dimension suitable for fixing the inner body (3) and the outer body (2) to each other and a cylindrical structure.

In a preferred embodiment of the invention, the fixing element (7) has a structure suitable for providing immobilization of the BRT applicator (1) inside the patient by connecting the BRT applicator (1) to the treatment table externally.

In a preferred embodiment of the invention, the fixing element (7) has a piece that has a structure suitable for holding the outer body (2) from its outer part and a surface that enables connection to the treatment table following this piece.

The inventive BRT applicator (1) enables to form patient-specific dose distribution.

The inventive BRT applicator (1) enables to increase comfort rate of treatment. The inventive BRT applicator (1) prevents harming healthy tissues around target volume through radioactive source by sending radioactive source the target tissue wherein treatment will be administered.

During clinical use of the inventive BRT applicator (1), steps of:

tandem insertion in compliance with the first guide cavity (21) shape into the body cavity;

inserting the inner body (3) into the outer body (2);

fixing the inner body (3) and the outer body (2) to the related place in the human body by proceeding them on the tandem by means of the first guide cavity (21) and the second guide cavity (31);

having computerized tomography (CT) in order to verify the place wherein fixing is performed;

inserting the radiation absorption element (4) and the source transfer channels (5) to the inner body (3) according to the localization of target and critical organs by utilizing CT sections;

determining the length of the radiation absorption element (4) and the position of the source transfer channels (5) by CT; taking the patient to treatment by controlling the planned treatment information upon performing treatment planning over CT sections are followed respectively.

Within these basic concepts; it is possible to develop various embodiments of the inventive vaginal intensity modulated brachytherapy (IMBT) applicator (1); the invention cannot be limited to examples disclosed herein and it is essentially according to claims.

Claims

1. A BRT applicator (1) comprising

at least one outer body (2) which is fixed to the vaginal cavity in human body;

characterized by

at least one inner body (3) which is inserted into the outer body (2); - at least one second guide cavity (31) which is located at the center of the inner body (3);

2. A BRT applicator (1) according to Claim 1; characterized by the outer body (2) which has a cylindrical structure.

3. A BRT applicator (1) according to Claim 1; characterized by the outer body (2) which is manufactured in various sizes such that it will be suitable for being inserted into the vaginal cavity in human body.

4. A BRT applicator (1) according to any of the preceding claims;

characterized by the outer body (2) which has a cavity that is suitable for inserting the inner body (3) into thereof.

5. A BRT applicator (1) according to Claim 4; characterized by the outer body (2) which has a cylindrical cavity.

6. A BRT applicator (1) according to any of the preceding claims;

characterized by the outer body (2) which has a structure such that it will comprise a first guide cavity (21) that is used while proceeding the BRT applicator (1) to the related point in the body at its center, after the inner body (3) is inserted into thereof.

7. A BRT applicator (1) according to any of the preceding claims;

characterized by the first guide cavity (21) which has a cylindrical structure.

8. A BRT applicator (1) according to any of the preceding claims;

characterized by the outer body (2) which makes it possible to insert different radiation absorption elements (4) and source transfer channels (5) during same treatment fraction because it is fixed to the vaginal cavity before the inner body (3) is inserted into thereof.

9. A BRT applicator (1) according to any of the preceding claims;

characterized by the inner body (3) which has a structure such that it will be able to fit into the cavity part located in the outer body (2).

10. A BRT applicator (1) according to Claim 9; characterized by the inner body (3) which has a cylindrical structure.

11. A BRT applicator (1) according to any of the preceding claims;

characterized by the inner body (3) which has a size such that it is suitable for entering the outer body (2) and which has cavities wherein at least one radiation absorption element (4) and at least one source transfer channel (5) can be inserted.

12. A BRT applicator (1) according to any of the preceding claims; characterized by the inner body (3) which has a structure such that it will comprise a second guide cavity (31) that is used while proceeding the BRT applicator (1) to the related point in the body at its center, after the radiation absorption element (4) and at least one source transfer channel (5) are inserted into thereof.

13. A BRT applicator (1) according to any of the preceding claims;

characterized by the inner body (3) which has a cylindrical structure.

14. A BRT applicator (1) according to any of the preceding claims;

characterized by the inner body (3) which has at least one channel on its outer wall.

15. A BRT applicator (1) according to any of the preceding claims;

characterized by the radiation absorption element (4) which enables to reduce the dose received by healthy tissues by absorbing the radiation that is emitted from the radioactive source used for tumor treatment.

16. A BRT applicator (1) according to any of the preceding claims;

characterized by the radiation absorption element (4) which is placed in a position that will correspond across the tissue where it is not desired to send radioactive source, into the inner body (3).

17. A BRT applicator (1) according to any of the preceding claims;

characterized by the radiation absorption element (4) which has a structure that is similar to shape of a piece obtained by dividing a cylinder diameter -center of which is empty in a round shape- into four and its every surface is filled.

18. A BRT applicator (1) according to any of Claim 1 to 16; characterized by the radiation absorption element (4) which has a structure that is similar to shape of a piece obtained by dividing a cylinder diameter -center of which is empty in a round shape- into two, three, five or a desired number and its every surface is filled.

19. A BRT applicator (1) according to any of the preceding claims;

characterized by the radiation absorption element (4) which is modularly attachable and detachable to the inner body (3).

20. A BRT applicator (1) according to any of the preceding claims;

characterized by the radiation absorption element (4) which makes it possible to apply different treatment plans successively due to the fact that it is modular.

21. A BRT applicator (1) according to any of the preceding claims;

characterized by the radiation absorption element (4) which consists of materials having different densities.

22. A BRT applicator (1) according to any of the preceding claims;

characterized by the radiation absorption element (4) wherein the material to be used for its production is selected depending on location of critical organs such as rectum and bladder and dose distribution.

23. A BRT applicator (1) according to any of the preceding claims;

characterized by the radiation absorption element (4) the length of which is adjusted in accordance with the treatment plan.

24. A BRT applicator (1) according to any of the preceding claims;

characterized by the radiation absorption element (4) an example of which is a material such as lead, titanium, aluminium and Teflon.

25. A BRT applicator (1) according to any of the preceding claims; characterized by the source transfer channel (5) which has a structure having channels wherein the transfer tubes where the radioactive source will pass are placed.

26. A BRT applicator (1) according to any of the preceding claims;

characterized by the source transfer channel (5) which has suitable dimensions whereby the transfer tubes where the radioactive source will pass can be placed

27. A BRT applicator (1) according to any of the preceding claims;

characterized by the source transfer channel (5) which is placed in a position that will correspond across the tissue where it is desired to send radioactive source, into the inner body (3).

28. A BRT applicator (1) according to any of the preceding claims;

characterized by the source transfer channel (5) which ensures that the radioactive source that will pass through the transfer tubes located inside thereof is sent to the target tissue at desired density.

29. A BRT applicator (1) according to any of the preceding claims;

characterized by the source transfer channel (5) which is modularly attachable and detachable to the inner body (3).

30. A BRT applicator (1) according to any of the preceding claims;

characterized by the source transfer channel (5) which makes it possible to apply different treatment plans successively due to the fact that it is modular.

31. A BRT applicator (1) according to any of the preceding claims; characterized by the source transfer channel (5) which has a structure that is similar to shape of a piece obtained by dividing a cylinder diameter - center of which is empty in a round shape- into four and wherein at least one channel is located in its inner surface.

32. A BRT applicator (1) according to any of Claim 1 to 30; characterized by the source transfer channel (5) which has a structure that is similar to shape of a piece obtained by dividing a cylinder diameter -center of which is empty in a round shape- into two, three, five or a desired number and wherein at least one channel is located in its inner surface.

33. A BRT applicator (1) according to any of the preceding claims;

characterized by the source transfer channel (5) part of which at a desired size can be arranged in a filled structure preventing passage of radioactive source.

34. A BRT applicator (1) according to any of the preceding claims;

characterized by the cap (6) which has a dimension suitable for fixing the inner body (3) and the outer body (2) to each other and a cylindrical structure.

35. A BRT applicator (1) according to any of the preceding claims;

characterized by the fixing element (7) which has a structure suitable for providing immobilization of the BRT applicator (1) inside the patient by connecting the BRT applicator (1) to the treatment table externally.

36. A BRT applicator (1) according to any of the preceding claims;

characterized by the fixing element (7) which has a piece that has a structure suitable for holding the outer body (2) from its outer part and a surface that enables connection to the treatment table following this piece.

37. A BRT applicator (1) according to any of the preceding claims; characterized in that it enables to form patient- specific dose distribution.

38. A BRT applicator (1) according to any of the preceding claims;

characterized in that it enables to increase comfort rate of treatment.

39. A BRT applicator (1) according to any of the preceding claims;

characterized in that it prevents harming healthy tissues around target volume through radioactive source by sending radioactive source to the target tissue wherein treatment will be administered.

40. A BRT applicator (1) characterized by following steps of:

inserting the inner body (3) into the outer body (2);

determining the length of the radiation absorption element (4) and the position of the source transfer channels (5) by CT; taking the patient to treatment by controlling the planned treatment information upon performing treatment planning over CT sections respectively during its clinical use.