WO2015136192A1

WO2015136192A1 - Brachytherapy device and associated therapeutic method

Info

Publication number: WO2015136192A1
Application number: PCT/FR2015/050539
Authority: WO
Inventors: Andriy BONDARYEV
Original assignee: Centre Hospitalier De Lens
Priority date: 2014-03-10
Filing date: 2015-03-05
Publication date: 2015-09-17
Also published as: EP3116596A1; FR3018196A1

Abstract

The present invention relates to a device for placing radioactive containers (1) in the area of a cancerous tumour, said device being of the type comprising a hollow needle (4), able to receive at least one container (1) of radioactive product, and a pusher (3) which is mounted so as to slide in said needle (4) along the length of the latter and which allows said container (1) to be pushed out of said needle (4). According to the invention, at least said needle (4) is able to be inserted into the canal of an echo-endoscope (310).

Description

BRACHYTHERAPY DEVICE-THERAPEUTIC METHODE

ASSOCIATED

The present invention relates to a brachytherapy device which comprises a needle capable of being inserted into the channel of an endoscope echo.

The endobrachytherapy method is widely used in the management of malignant tumors of various organs (prostate, cervix, endoluminal bronchial tumors, ENT cancer). One of the techniques used in the treatment of prostate cancer, for example, is the implantation of 1125 radioactive mini-containers into the prostate under ultrasound control by an endo-rectal ultrasound probe. This treatment is a direct intra-tumor implantation of the radioactive source which thus minimizes the harmful effects of radiation on the healthy tissues of neighboring organs.

Specific devices are used for the implementation of brachytherapy. These devices make it possible to precisely position the mini radioactive containers that will remain permanently in the body of the patient. Thus, document US Pat. No. 6,450,937 B1 describes a device for brachytherapy which comprises a hollow needle cannula having a beveled end capable of piercing the skin of a patient, a tube containing the radioactive containers and a pusher. The tube containing the radioactive containers is inserted into the hollow cannula. The pusher that slides in the cannula makes it possible to remove the tube containing the radioactive containers from the latter.

The use of this device is as follows: the tube containing the containers being in the cannula, the patient's skin is pierced with the beveled end of the latter in a translational movement. The beveled end is placed near the tumor. The pusher is inserted into the cannula at the back of the tube containing the radioactive containers. By slidably removing the cannula, the pusher remaining stationary, the tube is removed from radioactive containers out of the cannula without it moving in the body of the patient. In the field of pneumology, CT scans are currently being used to guide the percutaneous implantation of 1125 permanent implantable radioactive sources for the treatment of bronchopulmonary tumors. Other radioactive sources are used in superficial direct application on the surface of endoluminal tumors. The majority of these invasive techniques are not applicable for brachytherapy treatment of mediastinal and intra-abdominal tumors. Indeed, these tumors are surrounded by large mediastinal vessels and near the organs. The current techniques therefore imply too much risk of perforation either of the aforementioned vessels or organs located nearby.

An object of the present invention is to provide a novel brachytherapy device.

Another object of the present invention is to provide a brachytherapy device which is suitable for the treatment in particular of mediastinal and / or intra-abdominal cancerous tumors as well as for invaded mediastinal lymph nodes (mono or multi-site N2), in particular adjacent mediastinal lymph nodes. at the bronchial or tracheal wall.

For this purpose, the present invention provides a device for placing radioactive containers at the level of a cancerous tumor of the type comprising a hollow needle adapted to receive at least one radioactive product container and a pusher slidably mounted in said needle according to the length of the latter and for pushing said container out of said needle.

Typically, according to the invention, at least said needle is adapted to be inserted into the channel of an echo-endoscope.

The needle can thus be a flexible tube or a hollow fiber having a beveled end adapted to penetrate a tumor. Advantageously, the pusher is also adapted to be inserted into said echo endoscope channel.

The implantation of the radioactive product containers is thus done through the echo-endoscope channel which makes it possible to locate the tumor and the surrounding blood vessels. Advantageously, said needle is flexible at least on a portion extending from said beveled end. The needle being flexible it can deform including elastically; it can thus be handled and guided easily through the echo-endoscope channel. By bearing against the wall of the latter, the needle can be directed towards the tumor.

Advantageously, the pusher is also flexible so as to conform to the shape of the needle which bends in the channel. At least its portion which cooperates with the needle is flexible. Advantageously, the device further comprises a protective envelope of said needle, said envelope comprises an opening for allowing the passage of said beveled end and is flexible at least over a portion of length extending from said opening, said needle being rotatably mounted in said protective casing and the rotation of said needle in said casing causes said needle in translation in said casing.

Advantageously, at least the portion of the envelope that is adapted to be accommodated in the echo endoscope channel is also flexible, so as to follow the movements of the needle.

The protective cover protects the endoscope echo channel from the beveled tip of the needle that could damage or pierce it. The protective envelope also allows the two aforementioned combined movements of the needle in said envelope and in the endoscope echo channel, when the device of the invention is introduced into such a channel.

According to one embodiment, the device of the invention further comprises an element forming a portion of the channel of an endoscope echo, said needle possibly rotatably mounted in said protective envelope is slidably inserted in said channel along its length. and the device also comprises means for fixing said needle on said element.

Advantageously, the device comprises adjustment means in position of said needle in said channel.

Advantageously, said fixing means comprise a hollow support which extends said channel and a clamping ring which cooperates with said element forming said channel and said hollow support for fixing said support on said element. These fixing means also make it possible, as later discussed, adjust the length of the assembly element forming a portion of the channel endoscope echo -support.

According to a particular embodiment, said adjustment means in position of said needle in said channel comprise a threaded rod which passes through the wall of the support and cooperates with the outer surface of said needle / protective envelope for the frictional locking of said needle.

Advantageously, the device of the invention further comprises locking means in position of said needle in said endoscope echo channel.

According to a particular embodiment, said locking means in position comprises a nut rotatably mounted on the outer surface of said needle; said nut is adapted to abut against the end of said casing and / or said support facing the end of said pusher.

According to the invention, the device may comprise at least one radioactive product container housed directly in the light of said needle or inserted in a flexible sheath, itself housed in said needle; said sheath has an opening at each of its ends for the passage of the container out of the sheath and for the passage of said pusher.

The device of the invention may also comprise, in addition, a plug of material capable of preventing the propagation of radiation; the plug is disposed at one end of said sheath so as to prevent said container from coming out of said needle, when said needle contains said sheath. The cap can also be mounted on the beveled end of the needle or on its other end.

The sheath may be flexible, made of metal or any other material, in particular of radio-protective material. .

According to one embodiment, the pusher comprises a stopper. This stopper can be clipped onto the rod and its position can be adjusted along said pusher.

Advantageously, said envelope comprises at its end surrounding said beveled end of said needle protection means to prevent its piercing by said beveled end of said needle. These means of protection may be metal or polymer rings spaced apart from one another along a portion of the sheath or a spring surrounding a portion of the sheath, at the beveled end of the needle.

Advantageously, the end of said needle comprises, in particular at its bevelled end, a visualizable material by echo graphie, which allows to locate the position of the end of the needle by echo graphie and thus to avoid the vessels and surrounding organs.

The present invention also relates to a device comprising a needle according to the invention and an endoscope, more particularly an endoscope echo which has an endoscope echo channel, said needle being at least partially housed along its length in said channel.

As an indication but not limiting, the needle may have a length of at least 600 mm, for example 700 mm. The diameter of the thinnest part of the needle may be, for example, of the order of 1 mm or 1, 2 mm. Such a needle may contain a container of radioactive product, in particular 1125.

The present invention also relates to a method of treating cancerous tumors by brachytherapy, in particular mediastinal and intra-abdominal tumors according to which said tumor is located and an implanted radioactive product container is implanted in said tumor.

According to the invention, typically an echo-endoscope is provided which has a channel and a hollow needle which has a tapered end and contains said container of radioactive product and, in addition, a pusher slidably mounted in said needle, is provided said channel in the vicinity of said tumor, said needle is inserted into said channel, said tumor is pierced with said beveled end, and the pusher is actuated so that its end located in said needle abuts against said container, is removed. said needle of said tumor while leaving said pusher in place.

According to a particular mode of implementation, said needle is rotatably mounted in said channel, the rotation of said needle causes its displacement in translation in said channel, and said tumor is perforated by a combined movement of rotation and translation of said needle in said channel. Advantageously, said channel is disposed near said tumor by introducing said echo-endoscope through an intubation probe disposed in the respiratory system of the patient or directly in the patient's digestive tract.

The method according to the invention comprises the use of an echo-endoscopic guidance technique for implantation of permanent radioactive containers, in particular of 1125, in real time, for endobrachytherapy of tumors. Echo-endoscopy is here proposed for the therapeutic purpose of the adjacent extraluminal or mixed bronchopulmonary (or digestive) tumor for which other therapies are no longer indicated (tumor already irradiated in recurrence or in an unoperable patient). This approach is never used for implantation guidance of radioactive sources in bronchial or digestive extraluminal tumor through natural pathways.

DEFINITIONS

The term "flexible" refers to an element that can deform, possibly elastically, depending on its length; he can bend, bend or curl

The term protective radio refers to a material capable of limiting the propagation of radiation; it can be lead, for example.

The term "radioactive product" refers in particular to cesium-131, palladium-103 and iodine-125. Those skilled in the art are able to choose the most effective radioactive isotope, depending in particular on its radioactive half-life and the type of radioactive isotope. tumor to be treated.

The present invention, its characteristics and the various advantages that it provides will appear better on reading the following description of two particular embodiments of the device of the invention and which refers to the appended drawings in which:

- Figure 1A shows a sectional view along a longitudinal plane of the end of the sheath containing a radioactive product container and the end of the piston according to a first embodiment of the device of the invention; FIG. 1B shows a partial longitudinal sectional view at the end of the needle which cooperates with the pusher, of the first embodiment shown in FIG. 1A;

FIG. 2 shows a longitudinal section of the beveled end of the needle according to a particular embodiment of the invention;

FIG. 3 represents radioactive containers of type 1125 (Seed

1125);

FIG. 4 schematically shows the device of the invention cooperating with an echo-endoscope; and

FIG. 5 shows a longitudinal sectional view of a second embodiment of the device of the invention.

With reference to FIG. 1A, the radioactive product container 1 is disposed in a sheath 2, cylindrical and deformable material, for example metal. The sheath 2 is thus flexible along its length. The pusher 3 is introduced into the sheath 2 and abuts the rear of the container 1. A plug of radio-protective material equips the open end of the sheath 2, located opposite the end of the pusher 3. This plug 5 is removable; it makes it possible to transport the sheath 2 and the device according to the invention containing it without risk of losing the container 1, while limiting the risks of irradiation for the user. For this purpose, the sheath is also made of radio protective material.

With reference to FIG. 1B, according to the first embodiment of the device of the invention, the latter comprises a needle 4 in which the sheath 2 is inserted and a fixing ring (not referenced) of the sheath 2 in the needle 4. The pusher 3 comprises a stop 6 which is detachably engaged in a circular groove formed on the section of the pusher 3.

With reference to FIG. 2, the end of the needle 4 which allows the exit of the container 1 is tapered. The sheath 2 protrudes from the edge of the tapered end to prevent the incomplete expulsion of the container of radioactive product, during the implantation of the latter.

Fig. 3 represents a plurality of radioactive product containers which can be housed one behind the other in the sheath 2, their length being parallel to the length of the sheath 2. With reference to FIG. 4, the echo endoscope tube 200 which forms the echo endoscope channel is introduced close to the tumor T. The ultrasound head 10 generates a linear beam 40. The needle 4 being flexible, it can be deformed so as to exit in a direction not parallel to the channel of the endoscope echo. It can be inclined and deformed so that its beveled end stings and enters the tumor T.

With reference to FIG. 5, a second embodiment will now be described. The elements in common with the first embodiment are referenced identically. The needle 4 is flexible and can bend along its length. It has on its surface at least one thread 41. The needle 4 being hollow, it contains, as shown, two containers of radioactive product 1 which are not contained in a sheath but directly housed in the lumen of the needle 4. The end of the needle 4 which is opposite at the tapered end comprises a handle 43. A nut 45 is rotatably mounted on the outer surface of the needle 4, along the portion of the needle 4 disposed outside the casing 7. The Needle 4 can thus have two different threads along its length. The needle 4 is surrounded by a cylindrical envelope 7 in which the needle 4 is rotatably mounted. The pusher 3 is slidably mounted in the needle 4. The portion 71 of the casing 7 which is opposite the beveled end of the needle 4 has an internal thread 73 formed in a thicker portion. This internal thread 74 cooperates with the external thread 41 of the needle 4. The pusher 3 comprises a gripping member 31 and a clipped abutment 6. At least the part of the casing 7 which does not have the thread 73 is also flexible so as to be able to accompany the deformations and movements of the needle 4.

The rod of the pusher 3 is flexible and has a plurality of grooves spaced apart from each other by a distance equal to the length of the container 1 + 2mm. By moving the stopper 6 successively in each of the grooves, it is thus possible to precisely deliver the containers one by one.

In FIG. 5, the device of the invention comprises an external echo endoscope endpiece 30 which defines a portion of the endoscope echo channel 310. The end 33 of the outer endpiece 30 which is oriented toward the gripping element 31 comprises an external thread 35. The device comprises also a cylindrical support 9 whose one end comprises an annular rim 91 which extends in a plane substantially perpendicular to the length of the support cylinder 9. A fixing ring 100 which cooperates with the thread 35 of the tip 30 and with the rim annular 91 of the support cylinder is used to fix the end 33 on the flange 91.

As shown in FIG. 5, the tip 30 is secured to the support cylinder 9 by means of the ring 100. The needle 4 is inserted by rotation in the casing 7 and the casing 7 is slidably mounted in the assembly end 30-cylinder support 9 A perforation 93 is formed in the wall of the support cylinder 9; a threaded rod 95 equipped with a head and a flat end makes it possible to block the casing 7 in the support cylinder 9. By tightening the flat end of the threaded rod 95 against the outer surface of the casing 7, keeps the latter in position by friction

An example of use of the device of the invention will now be described with reference to the above figures. The patient is placed under general anesthesia with assisted ventilation under laryngeal mask or tracheal intubation. The endoscope is introduced by the intubation tube, the laryngeal mask or directly into the digestive tract (esophagus) depending on the location of the tumor to be treated. The tumor is identified with a color echo-doppler and the vascular network is assessed near the tumor. The support cylinder 9 is mounted on the end piece 30 of the endoscope echo channel and by translational displacement of the envelope 7 in the support cylinder 9 the length of the portion of the envelope 7 and thus of the needle 4 is adjusted. inserted into the endoscope echo channel. The threaded rod 95 is tightened so that its end comes into abutment with the outer surface of the envelope 7. By turning the needle 4 by means of the handle 43, the needle 4 is advanced in the envelope 7. Always turning the needle 4, the tumor is then penetrated in a combined rotational and translational movement, checking by ultrasound, in real time, that the needle remains at a distance from the blood vessels. The nut 45 is rotated so as to position it in abutment against the end of the casing 7 protruding from the support 9. The needle 4 and the casing 7 which cooperate in rotation are thus locked in position in the echo-endoscope channel 310. If the needle does not contain already the containers of radioactive product, it is placed or places directly in the needle 4 after removing the pusher 3. The nut 45 ensures a good locking of the needle 4 which allows to insert, without risk of displacement of the needle 4, the containers 1 in the light of the latter. The pusher 3 is replaced. The pusher 3 is then pushed towards the beveled end of the needle 4 so as to pull the container (s) 1 out. The stop 6 limits the stroke of the pusher 3 and allows precise positioning of the container 1 in the tumor. Simultaneously, the needle 4 is removed by turning it in the opposite direction to that previously used. Ultrasound control is performed on the position of the implanted container 1 in the tumor.

The abutment 6 is then moved into a further groove and the aforementioned steps are repeated so as to implant the container 1 situated just behind the one that has just been implanted.

The endoscope echo used may be an EBUS or EUS endoscope.

The tumor may be located in the mediastinal lymph nodes, in the lung; it may also be a malignant digestive tumor or a mediastinal tumor or an invaded mediastinal lymph node.

Claims

claims

1. Device for placing radioactive containers (1) at the level of a cancerous tumor of the type comprising a hollow needle (4), able to receive at least one radioactive product container (1) and a slidably mounted pusher (3) in said needle (4) according to the length thereof and for pushing said container (1) out of said needle (4), characterized in that at least said needle (4) is adapted to be inserted in the channel of an echo-endoscope (310).

2. Device according to claim 1, characterized in that said needle (4) is flexible at least on a portion extending from said beveled end.

3. Device according to any one of the preceding claims, characterized in that it further comprises a protective envelope (7) of said needle (4), in that said envelope (7) comprises an opening to allow the passage of said tapered end and is flexible at least over a portion of length extending from said opening, in that said needle (4) is rotatably mounted in said protective envelope (7) and in that the rotation of said needle (4) in said envelope (7) drives said needle (4) in translation in said envelope (7).

4. Device according to any one of the preceding claims, characterized in that it further comprises an element (30) forming a portion of the channel (310) of an endoscope echo, in that said needle (4) optionally mounted in said protective envelope (7) is slidably mounted in said portion of said channel (310) along its length and in that it also comprises means (100, 9) for fixing said needle to said element (30). ).

5. Device according to claim 4, characterized in that it comprises means for adjusting the position of said needle (4) in said channel (310).

6. Device according to any one of claims 4 and 5, characterized in that said fixing means comprise a hollow support (9) which extends said channel (310) and a clamping ring (100) which cooperates with said element forming said channel (30) and said hollow support (9) for fixing said support (9) to said member (30).

7. Device according to claim 5, characterized in that said adjustment means in position of said needle in said channel comprise a threaded rod (95) which passes through the wall of said support (9) and cooperates with the outer surface of said needle. (4) / protective casing (7) for frictional locking of said needle (4).

8. Device according to any one of claims 4 to 7, characterized in that it further comprises means for locking in position of said needle in said endoscope echo channel.

9. Device according to claim 8, characterized in that said locking means in position comprises a nut (45) rotatably mounted on the outer surface of said needle (4) and in that said nut (45) is fit to come in abutment against the end of said envelope (7) and / or said support (9) facing the end of said pusher (3).

10. Device according to any one of the preceding claims characterized in that it comprises at least one radioactive product container (1) housed in a flexible sheath (2), itself housed in said needle (4) and in that said sheath (2) has an opening at each of its ends for the passage of the container (1) out of the sheath (2) and for the passage of said pusher

(3).

1 1. Device according to claim 10, characterized in that it comprises, in addition, a plug (5) of material capable of preventing the propagation of radiation and in that the plug (5) is arranged at one end of said sheath (2). ) so as to prevent said container (1) from coming out of said needle

(4) when the latter contains said sheath (2).

12. Device according to claim 1 1, characterized in that said sheath (2) is metal.

13. Device according to any one of the preceding claims characterized in that said pusher (3) comprises a stop (6).

14. applicator device according to claim 13, characterized in that said stopper (6) is clipped on the rod of the pusher (3) and in that its position can be adjusted along said pusher (3).

15. Device according to any one of claims 3 to 14, characterized in that said protective envelope (7) has at its end protection means for preventing its piercing by said beveled end of said needle (4).

16. Device according to any one of the preceding claims, characterized in that said needle comprises, in particular at its beveled end, a visible material on ultrasound.

17. A method of treating cancerous tumors by brachytherapy, in particular mediastinal and intra-abdominal tumors according to which said tumor is located and an implanted radioactive material implanted in said tumor, characterized in that an echo-endoscope is provided which has a channel and a hollow needle (4) which has a beveled end and contains said container of radioactive product (1) and, in addition, a pusher (3) slidably mounted in said needle (4), in that one has said channel (310) in the vicinity of said tumor, in that said needle (4) is inserted into said channel (310), said tumor is pierced with said beveled end and the pusher is actuated ( 3) so that its end located in said needle (4) abuts against said container (1) and in that said needle (4) is removed from said tumor while leaving said pusher (3) square.

18. The method of claim 17, characterized in that said needle (4) is rotatably mounted in said channel (310), in that the rotation of said needle (4) causes its displacement in translation in said channel (310). and in that said tumor is perforated by a combined movement of rotation and translation of said needle.

19. Method according to one of claims 17 and 18, characterized in that said channel (310) is disposed near said tumor by introducing said echo endoscope through an intubation probe disposed in the respiratory system of the patient. or directly in the patient's digestive tract.