Apparatus for temporarily inserting and positioning at least one energy emitting source in an animal body

(57) The invention relates to a method and device for temporarily inserting and placing at least one energy-emitting source in an animal body, the device comprising at least a hollow open needle with a proximal and distal needle tip, which body is insertable to create a channel in the body; a guide tube with a proximal and distal guide end insertable into the hollow open needle; wherein the hollow open needle can be withdrawn from the body over the guide tube, a first mounting member for securing the guide tube to the body with the proximal guide end; a catheter tube with a closed distal catheter tube end and an open proximal catheter tube end, which is insertable into the guide tube and body through the proximal guide end with its distal catheter tube end and is attachable to the guide tube; at least one energy radiating source insertable into the catheter tube through the proximal catheter tube end, and which at least one energy radiating source is removed from the catheter tube after a predetermined time.

In accordance with the invention, the hollow open needle and the guide tube are insertable through a portion of the body, with both the proximal and distal ends located outside both sides of the portion of the body, and through a second fastening member for the distal guide end. attach the guide tube to the body.

NL C 1020740

The contents of this patent correspond to the original filed description with claim (s) and any drawings.

Short designation: Method and device for temporarily introducing and placing at least one energy-emitting source in an animal body.

DESCRIPTION

The invention relates to a method for temporarily inserting and placing at least one energy-emitting source in an animal body, comprising at least the steps:

A inserting at least one hollow open needle into the body with a proximal and distal needle tip to provide at least one channel in the body;

B inserting a guide tube with a proximal and distal guide end into the hollow open needle;

C withdrawing the hollow open needle from the body over the guide tube and simultaneously pulling the guide tube into position in the channel in the body;

D attaching the guide tube to the body with the proximal guide end;

E inserting a catheter tube with a closed distal catheter tube end and an open proximal catheter tube end through the proximal guide tube end, with the distal catheter tube end to a predetermined depth in the guide tube and body; and

F introducing at least one energy radiating source into the catheter tube through the proximal catheter tube end and up to the closed distal catheter tube end, and

G removing the at least one energy radiating source from the catheter tube after a predetermined time.

The invention further relates to a device for temporarily inserting and placing at least one energy-emitting source in an animal body, comprising at least:

A a hollow open needle with a proximal and distai

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sewing end to be inserted into the body to provide a channel in the body;

B a guide tube with a proximal and a distal guide end for insertion into the hollow open needle;

C wherein the hollow open needle can be withdrawn from the body over the guide tube;

D a first fastening element for fastening the guide tube with the proximal end to the body, and

E a catheter tube having a closed distal catheter tube end and an open proximal catheter tube end insertable through the proximal guide end with its distal catheter tube end to a predetermined depth in the guide tube and body; and

F at least one energy radiating source insertable into the catheter tube through the proximal catheter tube end and up to the closed distal catheter tube end;

G which at least one energy radiating source is removed from the catheter tube after a predetermined time.

During brachytherapy, a radioactive source is brought in close proximity to cancerous tissue to irradiate that cancerous tissue with radioactive radiation. Several proposals have been made for facilities to perform such processes. Such processes are known, for example, as low dose manual brachytherapy using threads, seeds, grains and tubes, and high dose brachytherapy or remote HDR brachytherapy. In LDR and HDR brachytherapy (LDR = low dose rate, low dose; HDR = high dose rate, high dose), one or more radioactive sources of low and high intensity, respectively, are attached to a distal end of a so-called guidewire, which ie remote charging. Certain cancers, such as prostate or breast cancer, require more than one radiation dose divided over time to be effective. Those doses are given over a period of several days. A patient must be hospitalized during that time. Each time a dose is to be administered during that time, needles are inserted into the patient's body and treatment is started.

It is also known to leave the needles in the body. In particular, HDR brachytherapy requires only a few minutes or less for a dose. For a patient, such a method therefore means a long time in the hospital for some short-term treatments. Patients 10 experience such a method as quite burdensome.

It is known in brachytherapy to introduce a number of needles into a body semi-permanently for the entire duration of the treatment. In that case, a number of needles are introduced into the body, usually by means of a template, and are fixed relative to the body by means of a fastening element. The template can also function as a mounting element. Each of the needles is then provided with a coupling. All needles protrude a certain distance from the body and are provided with a coupling. So-called guide tubes or transfer tubes can be connected to the needles 20 via the couplings. As is known in brachytherapy, a so-called post-loading machine can be used to control the transport of the radiation source from the machine to the needles via the guide tubes or transfer tubes. A post-loading machine is therefore provided with an indexing device. The guide tubes or transfer tubes, the ends of which are coupled to the fastening element, are in turn coupled to the indexer at their other ends. As is known from post-brachytherapy machines provided by, for example, Nucletron BV sold in the Netherlands, a radioactive source on a distal end of a so-called guidewire under the control of the machine is transported from a vault in the machine through the indexer to the guide tube and through the guide tube to a corresponding needle. After a certain time, the wire with the radioactive source is withdrawn into the after-loading machine. In case further irradiation is to be done from another needle, the indexer is controlled to connect a further guide tube 5 to receive the wire with the radioactive source at the end. This is continued until all required irradiations have taken place from the various needles. The needles are then detached from the guide tubes. The patient is then free to walk around with a set of needles in his or her body until the next treatment is due. It is known to use plastic needles that have a small amount of flexibility, rather than non-flexible metal needles. The above description also relates to such flexible plastic needles.

During no treatment periods, the patient is theoretically free to walk around, but in practice the set of needles or flexible tubes protruding from the body prevents the patient from really feeling free.

A method and an apparatus according to the aforementioned preamble are disclosed in U.S. Patent US 20 6,251,060-B1 issued to the applicant of this application.

In US 6,251,060-B1, a radioactive source is inserted through a needle into a guide tube contained in a body, which needle is attached to the body skin with one end by additional means, such as adhesive tape and a fastener. The other end of the insertion needle is inserted into the body to a certain depth, depending on the radiation therapy treatment. In order to obtain proper attachment or placement of the radioactive source within the body, the guide tube or guide shaft may be partially compressed by pressures exerted on the shaft by the body tissue. The non-compressible end portion of the guide shaft

0407 contained in the body serves as an anchor device for the radioactive source contained in the closed end of the shaft in the body.

In order to aid the above complicated insertion process of a radioactive source into the body, the closed end of the guide shaft present in the body is provided with an X-ray-impermeable marker for checking the exact placement of the shaft within the body using known imaging means.

Apart from the complex parts for connecting the guide shaft to the skin of the patient's body, the method and apparatus of US 6,251,060-B1 are subject to problems regarding the exact positioning of the energy radiating source within the guide shaft in the body since the guide shafts are connected to the body skin on one side only and are subject to displacements of the other, closed end in the body in relation to the cancerous tumor to be treated.

Therefore, the method and apparatus for temporarily inserting and placing a radioactive source into an animal body according to US 6,251,060-B1 are not useful for temporarily inserting and precisely placing a radioactive source during subsequent radiotherapy treatment sessions to perform radiotherapy treatments under the same parameters. Furthermore, the known method and device are not suitable for the rapid introduction and placement of an energy-radiating source in a rapid manner without being unpleasant for the patient.

Furthermore, the known method and device according to US 6,251,060-B1 are not suitable for the use of energy-radiating sources with a high dose rate (HDR sources) because of the undesired exposure to radiation of the skin and body tissue in the vicinity of the cancerous growth. .

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The present invention aims to avoid the above-described problems and aims to provide a method and device for temporarily inserting and placing at least one energy-emitting source in an animal body, which method is further characterized by the steps:

H the at least one hollow open needle inserted during step A and the guide tube inserted during step B are inserted through a part of the body with both the proximal and distal ends of the guide tube outside both sides of the part of the remain in the body, and

Attaching the guide tube relative to the body with the diagonal guide end.

The device according to the invention is characterized in that the hollow open needle and the guide tube are inserted through a part of the body with both the proximal and distal ends remaining outside both sides of the part of the body, and

<td>by a second</td><td colspan="3">fixing element for the</td><td>with the</td><td>distal</td>

<td>guide end</td><td>ten</td><td>relative to it</td><td>1 body</td><td>to confirm</td><td>of the</td>

<td>guide tube. Through</td><td>it</td><td>placing both</td><td colspan="2">the proximal as</td><td>distal</td>

end of the guide tube outside of both sides of the body and attaching both guide tube ends, proper attachment of the guide tube to the body is obtained, allowing an exact placement of the energy radiating source within the guide tube relative to the cancerous tumor to be treated is guaranteed. This exact placement is maintained during subsequent radiotherapy treatment sessions, and due to the two-sided attachment of each guide tube to the cancerous tumor to be treated, no adverse displacement of the guide tubes can occur, which would lead to a relocation or displacement of the guide tubes within the body. lead.

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· «I

According to a further aspect of the invention, the energy radiating source is inserted into the catheter tube by means of a flexible wire having a proximal and dista wire end, the energy radiating source being attached to the distal wire end of the flexible wire.

More specifically, the catheter tube with the proximal catheter tube end is connected to a recharging device, the flexible wire with the proximal wire end being connected to drive means for the energy emitting source of the recharging device.

This allows the use of multiple radiotherapy treatments in which sources of radiant energy can be easily introduced and withdrawn through the catheter tube and guide tube. Therefore, only a pair of guide tubes need to be inserted into the body near the cancerous tumor to be treated, which guide tubes must be connected to the body at both the distal and proximal ends located outside the body. This not only ensures correct orientation of the guide tubes throughout the radiotherapy treatment, as noted above, but also minimizes patient discomfort.

The inconvenience to the patient is further minimized when in a further aspect of the device according to the invention the catheter tube is made of a flexible material, such as plastic. The flexible catheter tube is therefore very suitable for monitoring the curvature of the body, more particularly the curvature of a woman's chest and chest during insertion.

In order to facilitate subsequent insertion and withdrawal of the catheter tube into each guide tube during subsequent radiotherapy treatments, the guide tube between the proximal and distal guide ends is non-compressible.

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According to a further aspect of the invention, the horizontal end of the guide tube has a smaller diameter than the rest of the guide tube. This property reduces the formation of scars on the surface of the skin on one side of the body where the 5 guide tubes are exposed outside the patient's body.

For the purpose of facilitating and obtaining more accurate placement of the guide tubes relative to the cancerous tumor to be treated, in accordance with the invention, a template is temporarily placed on both sides of the portion of the body 10 for placement of both the proximal and distal ends of the hollow needle. More specifically, both templates are applied to one fixed element.

According to a further aspect of the device according to the invention, the first fastening element has means for fastening to the proximal end of the guide tube, the fastening means comprising two protruding parts which extend parallel to each other and are separated by two slots.

The mounting of the fastener on each proximal end of the guide tube is facilitated by the fact that the two protruding parts are moved apart by the interaction between the slots and the legs of a tweezer-like device.

More specifically, each leg of the tweezer-like device is provided with a notch that interacts with each slot.

According to a further aspect of the device according to the invention, the treatment device can be attached to the fastening element by means of a coupling device, the coupling device having a part of a click coupling, and another part of the click coupling being part of the fastening element, or in which the coupling device has a part of a compression and friction coupling and another part of the compression and friction coupling forms part of the fastening element, or in which the coupling device is one part of a key and lock coupling and another part of the key and lock coupling is part of the fastening element.

For a correct and precise connection between the conduit and. the fastener close to the body skin is the guide tube made of a heat-fusible material and adheres the heat-melted guide tube after cooling and to the fasteners.

In another aspect of the device of the invention, the energy radiating source is a high dose radioactive source.

In accordance with another aspect of the device according to the invention, the energy-emitting source is an activatable energy-emitting source that can be switched between an activated and non-activated state, and more particularly, the activatable energy-emitting source is an X-ray source, a a light-emitting device or a radiation source, such as a radiation source with a high dose (high dose rate), a pulse dose (Pulse Dose Rate) or a low dose (Low Dose Rate).

In accordance with a further aspect of the invention, a vacant wire is introduced into the empty conduit after removing the treatment device.

Further details, advantages and features of the invention are shown not only in the claims and their properties, alone and / or in combination, but also in the following description of preferred embodiments shown in the drawing, which drawing shows:

Figures 1A-1L schematically show the successive steps of the method according to the invention using an embodiment of a device according to the invention;

Figure 2 shows another embodiment of the device

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according to the invention in more detail;

Figure 3 shows another embodiment of the device according to the invention in more detail.

In Figures 1A through 1L, a body and more particularly a breast of a woman is indicated by the number 1. Templates 5a and 5b can be placed on either side of the chest where needles are to be inserted. In order to achieve proper mutual alignment of the templates 5a and 5b, both templates are mounted on a fixed element (not shown).

Using the templates 5a-5b or using other types of alignment indicia on, for example, the body 1, one or more open needles 2a-2e (for illustrative purposes only, five needles 2a-2e are used here), each provided with a trocar needle 3a-3e disposed therein, inserted into body 1 in the vicinity of a cancerous growth (not shown). Each trocar needle 3a-3e fills an open needle 2a-2e so that a channel, generally 4a-4e (see Figure 1D), is formed during insertion into the body.

As is clearly shown in Figures 1A-1C, the hollow needles 2a-2e are inserted entirely through the part of the body or chest 1, with both ends exposed outside both sides of the chest 1.

Then, as in Figure 1C, the trocar needles

3a-3e withdrawn. The open needles 2a-2e remain in the body, the channels 4a-4e being retained. Then, as shown in Figure 1D, both templates 5a-5b are removed.

Then 2a-2e guide tubes 6a-6e are inserted through each open needle. Once the guide tubes 6a-6e are fully inserted through the open needles 2a-2e, both ends of the guide tubes 6a-6e are exposed outside both sides of the breast. The support provided by needles 2a-2e for maintaining channels 4a-4e is no longer required and the open needles 2a-2e are removed from the chest, as shown in Figure 1F, and along with the removal of the open needles the guide catheters are pushed into place.

Then, each guide tube 6a-6e is further advanced through the body part (or chest 1) until a closed distal end 7a-7e of the guide tube 6a-6e, which is provided with a fastening element 9a9e, abuts the skin of the chest 1. This situation is shown in Figure 1G.

Then, a further mounting member 10ai-10e (see Figure 1H) is slid over the other open proximal end 8a-8e of each guide tube 6a-6e. According to the invention, each fastening element is provided with two protruding parts 14a-14b, which extend parallel to each other and which are separated by two slots 15a-15b (one slot 15a is shown in Figures 1H-1L). These two protruding parts 14a-14b are pressed apart by the interaction between the slots 15a-15b and the legs of a tweezer-like device (not shown) to allow the sliding movement of the fastener 10a-10e over the proximal end 8a-8e of every 20 guide tube.

Once the fasteners 10a-10e are against the skin of the chest 1, as shown in Figure 1H, the two protruding parts 14a-14b are released and by their resilience clamp against and around the open proximal end 8a-8e of each guide tube 6a-6th.

In Figure II, the proximal ends 8a-8e of each guide tube are cut to a desired length.

Then, the fasteners 10a-10e and the open proximal ends 8a-8e of each guide tube 6a-6e are interconnected, for example, by gluing. In a preferred embodiment 30, however, the guide tubes 6a-6e are made of a heat-fusible plastic material, which material, when placed in a heat-

10207 The molten state is brought by means of supplying energy using a suitable device 11, can be brought into contact and after cooling can be firmly connected to the fasteners 10a-10e. These steps are shown in Figures IJ and IK.

After connecting the open proximal ends 8a-8e to the fasteners 10a-10e, the guide tubes 6a-6e are now attached to both sides of the chest 1, ensuring proper fixation of the guide tube for subsequent radiotherapy treatments, without the risk displacement of the guide tubes in the body relative to the cancerous tumor to be treated.

Preferably, the guide tubes are made of a flexible material, such as plastic, to assist the patient in his or her daily behavior during non-treatment periods. This therefore means that the patient is theoretically free to walk outside the hospital since no energy radiating source is present within the guide tubes 6a-6e for a longer period of time. The fasteners 9a-9e and 10a-10e preferably have a round shape, which is considered to be patient or user-friendly since the skin is less irritated.

To perform radiotherapy treatment, hollow needles or catheter tubes 12a-12e, each with a closed distal end 13a-13e, are inserted into the breast 1 through the guide tubes 6a-6e through the open proximal guide tube ends. Preferably, the catheter tubes 12a-12e are each inserted into the guide tube with the closed end 13a-13e to a predetermined depth, the insertion depth for each catheter tube being determined separately, depending on the location of the cancerous growth relative to the guide tubes and the planning parameters of radiotherapy treatment, such as those planned in advance by the medical personnel who administer the sources of radiant energy to the patient.

Within each closed-end hollow catheter tube sew 10, a plurality of radioactive seeds, 11, separated if necessary by non-radioactive spacers 12, are provided. After the closed-end hollow needle 10 for catheter tubes 12a-12e has been in place for a time desired for each radiotherapy treatment, it is withdrawn and can be stored with the radioactive seeds and the non-radioactive spacers therein until the next treatment of the same patient.

However, the method and device according to the invention are very suitable for the use of a high dose or a post-HDR distant brachytherapy. In this radiotherapy, the catheter tubes 12a-12e with their open proximal catheter tube ends are connected via the indexing means of the recharging device to a recharging device (not shown). Thereafter, a flexible source wire (not shown) with its distal free end is inserted into the catheter tube 12a12e up to the closed distal end 13a-13e of the catheter tube.

The flexible wire is therefore connected at its proximal end to the drive means of the energy-emitting source contained in the recharging device. When using the indexing means and the driving means, the flexible wire is passed through one of the several catheter tubes 12a-12e. An energy radiating source is connected to the distal end 13a of the flexible wire and thus is also inserted into the catheter tube 12a by the drive means of the recharging device until the energy radiating source abuts the closed distal end 13a-13e of the catheter tube 12a-12e. . This ensures proper placement of the energy radiating source within the breast 1 relative to the cancerous tumor to be treated. See also the detailed view of figure

2.

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The energy radiating source may be a high dose radioactive source (HDR source) or a low dose radioactive source (LDR source) depending on the type of radiotherapy treatment to be performed.

The energy radiating source may also be an activatable energy radiating source which can be switched between an activated and an unactivated state. The activatable radiation source may be an X-ray emitting source, and more particularly a miniature X-ray emitting source.

This allows the radiation dose to which the cancerous tumor to be treated as well as the skin and healthy body tissue of the patient is exposed to be well controlled.

Since it is desirable to keep the guide tubes 6a-6e open during the insertion of the catheter tube 12a-12e and the flexible wire with the energy radiating source, the guide tubes 12a-12e are made of a material that is flexible and comfortable for the patient but which material is further non-compressible between the diagonal and proximal guide ends.

In order to avoid or reduce scarring of the skin into which the trocar needle 2, 3 with its distal end (reference numerals 7a-7e in Figure 1G-1I) penetrates, needles 2a-2e and guide tubes 6a-6e can be provided from a distal end smaller in diameter than the rest of the needle 2 and the guide tubes 6a-6e. This is shown in Figure 3, where each guide tube 6a-6e is provided with a distal end 7a'-7e 'with a reduced diameter.

This embodiment of the device according to the invention also requires a different order of insertion and placement of the guide tubes in the chest 1. Once the hollow needles 2a-2e are inserted into the body (chest 1), their smaller distal ends are extended outside the body exposed at side 5a (figure 1).

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Then, the guide tubes 6a-6e with a correspondingly small distal end 7a'-7e 'are inserted through the proximal end of the open needle 2a2e (reference 5B in Figure 1A). After removing the open needle 2a-2e, the smaller diagonal ends 7a'-7e 'of each 5 guide tube are connected to the fasteners 9a-9e.

The smaller exit of the guide tube 6a-6e at its distal end through the patient's skin reduces the patient's discomfort during subsequent radiotherapy treatments, and also reduces scarring.

It should be noted that, in accordance with the above, several changes may be obvious to one skilled in the art. Such changes are considered to fall within the scope of the invention.

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