DE102022209893A1 - Applicator assembly for use in radiotherapy and method of operating a radiotherapy device - Google Patents

Abstract

The invention relates to an applicator arrangement (1) for use in radiation therapy, comprising an applicator (2) which is designed to be connected to a radiation source (10-1) of a radiation therapy device (10) at an interface (2-1) designed for this purpose to be and/or at least partially accommodate the radiation source (10-1), and a drape film (3) for at least partially covering a holding device (10-2) of the radiation therapy device (10), the drape film (3) being in the area of the interface ( 2-1) is firmly connected to the applicator (2). The invention further relates to a method for operating a radiation therapy device (10).

Description

The invention relates to an applicator arrangement for use in radiotherapy and a method for operating a radiotherapy device.

In intraoperative radiotherapy or radiotherapy (IORT), so-called applicators are used for tumor bed irradiation (e.g. in the INTRABEAM system from Carl Zeiss Meditec AG). The applicators provide access to the radiation site in the patient's body. The applicators partially absorb the X-rays and can therefore influence the radiation. This influence must be taken into account when planning radiation treatment. The relevant applicator data (e.g. depth-dose curve) is usually saved on a computer for radiation planning.

Each applicator enables the insertion of a miniaturized movable X-ray source in such a way that an isocenter of the X-ray source as the origin of the X-rays is in a defined position (e.g. in a spherical center of the applicator). The applicator and the X-ray source form a unit for the period of irradiation and are held in position and orientation (position) by a holding device during irradiation. Such a holding device can be, for example, a tripod with several axes of movement or degrees of freedom. Normally, the operator, e.g. a surgeon or an assistant, moves the applicator into the tumor cavity with the aid of the holding device, with the applicator then being held in the desired position by the holding device during the irradiation.

Before and during treatment, at least the part of the holding device that is in (or adjacent to) the sterile area must be covered with a sterile cover. A sterile drape film is used for this. Before treatment, the sterile drape film must be placed on an applicator that is adapted to the size and shape of the treatment. To do this, the applicator must be held awkwardly and placed in the correct position on the drape film. Due to improper handling, unwanted contamination can occur.

The invention is based on the object of improving the handling of the applicator and the drape film when preparing the treatment.

The object is achieved according to the invention by an applicator arrangement with the features of patent claim 1 and a method with the features of patent claim 12. Advantageous embodiments of the invention result from the subclaims.

It is one of the basic ideas of the invention to create an arrangement which includes an applicator and a drape film (which can also be referred to as a cover film) in a state that is already firmly connected to one another. It is provided here that the drape film is firmly connected to the applicator in the area of an interface at which the applicator is connected to a radiation source. Such a connection can include further elements, such as rings, for example a foam ring, or one or more intermediate pieces (s), in which case these are firmly connected to one another, so that overall a solid connection is formed between the applicator and the drape film. The fixed connection between the applicator and the drape film is designed in particular in such a way that a sterile barrier is formed. The connection between the applicator and the drape film can in particular be a cohesive connection, for example an adhesive or welded connection (e.g. by pressure or friction welding). In principle, the connection between the applicator and the drape film can additionally or alternatively also be formed by means of positive connection or frictional connection, as long as a sterile barrier can be formed in this way.

In particular, an applicator arrangement for use in radiation therapy is created, comprising an applicator which is designed to be connected to a radiation source of a radiation therapy device at an interface set up for this purpose and/or to at least partially accommodate the radiation source, and a drape film for at least partially covering a Holding device of the radiation therapy device, the drape film being firmly connected to the applicator in the area of the interface.

Furthermore, in particular, a method for operating a radiation therapy device is provided, wherein the applicator arrangement described in this disclosure is used, the applicator of the applicator arrangement being arranged on a radiation source of the radiation therapy device, and wherein the drape film of the applicator arrangement is wrapped around at least a part of the holding device close to the applicator Radiation therapy device is arranged around.

It is in particular provided that the applicator arrangement is a disposable product and/or is designed and/or used as such. This can ensure improved sterility because no reprocessing of a used applicator has to take place, but rather sterilization only has to take place once after the applicator arrangement has been manufactured. Problems with the spread of germs, which can occur with repeated use, can also be avoided in this way.

An advantage of the applicator arrangement and the method is that the applicator does not have to be laboriously arranged on the drape film before treatment. On the other hand, the applicator is already provided with the drape film firmly attached to it. The step of arranging the applicator on the drape film, which carries a risk of contamination, can therefore be omitted. Furthermore, time and effort can be saved due to the already formed fixed connection.

A radiation source is in particular an X-ray source. In principle, the radiation source can also be another radiation source, for example a radionuclide source, for irradiating tissue.

An applicator is in particular a unit that is arranged on a radiation source, in particular on an (X-ray) radiation source, and is applied to a tumor region for irradiation and/or is introduced into a tumor cavity in a patient. The applicator comes into contact with the patient's tissue and enables access to the irradiation site on or in the patient's body (e.g. as an applicator with a flat surface for use on the body, as an applicator with a spherical shape for use in a tumor cavity or as a needle-shaped applicator for Use in the body without prior tumor removal). The applicator partially absorbs (X-ray) radiation and can therefore influence the radiation depending on the direction via a directional wall thickness. Furthermore, the applicator can also be used for positioning and/or holding tissue within a tumor cavity through appropriate shaping.

The applicator enables, in particular, the insertion of a miniaturized movable X-ray source at the interface in such a way that an isocenter of the X-ray source, as the origin of the X-rays, is in a defined position (e.g. in a spherical center of the applicator). The applicator and the X-ray source form a unit for the period of irradiation and are held in position and orientation (position) by a holding device of a radiation therapy device during irradiation. Such a holding device can be, for example, a tripod with several axes of movement and/or degrees of freedom. Normally, the operator, e.g. a surgeon or an assistant, moves the applicator into the tumor cavity with the aid of the holding device, with the applicator then being held in the desired position by the holding device during the irradiation.

The drape film in particular comprises a suitable plastic. For example, polyethylene (PE) can be used for this. It can be provided that the drape film has one or more elastic bands. A shape of the drape film can basically be designed in any way, as long as complete encapsulation and/or sheathing of the holding device in the desired area is possible.

The holding device can in particular be a tripod. In particular, the stand can be a multi-jointed stand that can be moved about several axes and/or can provide several degrees of freedom for the (X-ray) radiation source and the applicator arranged thereon. The tripod can in particular be a 6-axis tripod. The tripod is in particular supported mechanically and/or motorically, for example with the help of servo motors.

In one embodiment it is provided that the applicator and the drape film are sterile. This means that no sterilization has to be carried out before treatment. In particular, the applicator arrangement is manufactured and/or provided as a sterile disposable product.

In one embodiment it is provided that the drape film is designed to be tubular at least in sections. This enables easier arrangement on the part of the holding device close to the applicator. The tubular drape film can then be pulled over the holding device, in particular over a stand arm, in a simple manner without much effort. It can be provided that the hose shape widens as the distance from the applicator connected to it increases. Furthermore, it can be provided that the hose shape is adapted to the holding device according to a predetermined profile (of the holding device). It can be provided that the tubular drape film has one or more, in particular circular, elastic bands arranged on a circumference of the hose, with which a diameter of the tubular drape film can be locally reduced by elastic tension. This makes it easier to arrange and/or fix the drape film on the holding device. It can also be provided that the applicator arrangement has bands for fixing and/or constricting the drape film.

In one embodiment it is provided that the drape film is in the area of the fixed connection with the interface is broken and the permanent connection is limited to an outside area of the interface. The fixed connection, for example the adhesive or welded connection, runs in particular in a circle around the interface. The drape film can, for example, be broken through a circular recess.

In one embodiment it is provided that the applicator is arranged within the drape film, at least in a delivery state of the applicator arrangement, so that the drape film surrounds the applicator, such that an outer side of the drape film in the use state (i.e. after arranging the drape film around the holding device) is in the When delivered, it faces inwards towards the applicator and access to the interface is not covered by the drape film. Correspondingly, after the drape film has been arranged around the holding device (i.e. in the use state), a side of the drape film that is on the outside in the delivery state points inwards towards the holding device. In other words, the drape film is arranged in an inverted state in the delivery state compared to a use state. In other words, this means that the applicator arrangement can have a delivery state. When delivered, the applicator is expediently arranged within the drape film. In particular, in the delivery state, the drape film can at least essentially surround the applicator. Furthermore, the applicator arrangement can have a use state. In the state of use, the drape film is expediently arranged around the holding device in such a way that one side of the drape film, which is on the outside in the delivery state, points inwards towards the holding device in the state of use. This allows the placement of the applicator and the drape film on the radiation source and the holding device of the radiation therapy device to be accelerated. In particular, the applicator can then be gripped through the, in particular tubular, drape film, the miniaturized (X-ray) radiation source can be arranged in the applicator and the interface can be connected to the (X-ray) radiation source. The drape film, in particular tubular form, is then pulled around the applicator over the holding device and thereby transferred in particular into the state of use. In other words, in this last step the drape film is pulled or turned inside out from left to right.

In particular, in one embodiment of the method it is provided that the applicator is first arranged at the radiation source of the radiation therapy device and then the drape film is pulled along the applicator over the part of the holding device close to the applicator. In this way, the applicator arrangement can be brought into the use state.

In one embodiment it is provided that the applicator arrangement has at least one machine-readable identifier with which the applicator arrangement can be clearly identified. This allows the applicator arrangement to be clearly identified before treatment. This makes it possible to match a shape and/or size with treatment requirements. This also makes it possible to check whether the applicator arrangement has already been used or is unused. This can further increase safety in terms of sterility and contamination.

In one embodiment it is provided that the applicator arrangement has at least one RFID transceiver arranged on the applicator and/or the drape film, which forms and/or provides the at least one machine-readable identification. This enables wireless capture and/or reading of the machine-readable identification. In particular, reading can also be carried out using a detection device (in particular an RFID reader), which does not have to be arranged in the immediate vicinity of the RFID transceiver, but can also be located at some distance in a non-sterile area, for example. The at least one RFID transceiver can in particular be arranged at an end of the drape film that is remote from the applicator.

In one embodiment it is provided that the applicator arrangement has at least one identification that can be optically detected on the applicator and/or the drape film and which forms and/or provides the at least one machine-readable identification. Such an optically detectable identification can be designed, for example, as a barcode or QR code. Detection is then carried out in particular by means of a detection device set up for this purpose. The at least one optically detectable marking can in particular be arranged at an end of the drape film remote from the applicator.

In one embodiment it is provided that the applicator arrangement has at least one human-readable identification with which the applicator arrangement can be clearly identified. This means that the applicator arrangement can also be clearly identified by a user. For example, the at least one human-readable identifier Include letters, numbers, color codes, symbols and/or pictograms.

In one embodiment of the method it is provided that at least one machine-readable and/or human-readable identification of the applicator arrangement used is read out and/or recorded and/or registered in a database by means of at least one detection device. This allows the identity of the applicator arrangement to be detected automatically.

In a further embodiment of the method it is provided that the read and/or recorded and/or registered identification is used to check whether the applicator arrangement used has already been used. This can increase safety in terms of sterility and contamination. In particular, it can be provided that a release signal and/or a blocking signal for operation of the (X-ray) radiation source are generated depending on a check result. If the checking shows that the applicator arrangement has not yet been used, for example because a corresponding entry is missing in a database held for this purpose, then the release signal is generated and output or the blocking signal is deactivated. However, if the checking shows that the applicator arrangement has already been used during a treatment, for example through a corresponding entry in the database, the release signal is not generated or the blocking signal is generated and output. As part of the checking, in particular the identification and/or an identity of the applicator arrangement derived from the identification can be queried in the database.

In one embodiment it is provided that the applicator arrangement is packed in a blister. As a result, the complete applicator arrangement can be provided in a single package, particularly sterile in terms of contents.

Furthermore, an entirety of applicator assemblies is also created, comprising a plurality of applicator assemblies according to one of the embodiments described in this disclosure or according to a combination of embodiments described in this disclosure, wherein the applicator assemblies within the entirety are each individually identified by a unique identifier. The applicator arrangements as a whole differ, in particular at least in groups, in size and/or shape. It can then be provided that, before the treatment, an applicator arrangement suitable for the treatment in terms of size and/or shape is selected from the entire set and used, in particular as a sterile disposable product. After the treatment, the applicator arrangement is in particular disposed of.

• 1 eine schematische Darstellung einer Ausführungsform der Applikatoranordnung;
• 2 eine schematische Darstellung zur Verdeutlichung einer Ausführungsform der Applikatoranordnung;
• 3a-3c schematische Darstellungen einer Ausführungsform der Applikatoranordnung;
• 4 eine schematische Darstellung einer weiteren Ausführungsform der Applikatoranordnung;
• 5 eine schematische Darstellung einer an einer Halteeinrichtung einer Strahlentherapievorrichtung angeordneten Ausführungsform der Applikatoranordnung.

The invention is explained in more detail below using preferred exemplary embodiments with reference to the figures. Show here:

• 1 a schematic representation of an embodiment of the applicator arrangement;
• 2 a schematic representation to illustrate an embodiment of the applicator arrangement;
• 3a-3c schematic representations of an embodiment of the applicator arrangement;
• 4 a schematic representation of a further embodiment of the applicator arrangement;
• 5 a schematic representation of an embodiment of the applicator arrangement arranged on a holding device of a radiation therapy device.

The 1 shows a schematic representation of an embodiment of the applicator arrangement 1 (in 1 a usage state 21 is shown as an example). The applicator arrangement 1 comprises an applicator 2 and a drape film 3.

The applicator 2 is set up to be connected to a radiation source 10-1 of a radiation therapy device 10 at an interface 2-1 set up for this purpose and/or to at least partially accommodate the radiation source 10-1. In particular, a miniaturized radiation source 10-1 is introduced into the applicator 2 (see also needle 10-3 in 3a) , so that a target of the (X-ray) radiation source 10-1 is arranged within a designated area 2-2 of the applicator 2.

The drape film 3 serves (in the use state 21) to at least partially cover a holding device 10-2 of the radiation therapy device 10. For this purpose, the drape film 3 is or is arranged in particular around a part of the holding device 10-2 close to the applicator and encapsulates this from a sterile area.

The drape film 3 is firmly connected to the applicator 2 in the area of the interface 2-1. The connection can, for example, be designed as a cohesive connection, which can be formed, for example, by gluing and / or welding the drape film 3 to the interface 2-1. Basically, additional or alternative but Positive and/or non-positive connections are also possible.

The applicator 2 and the drape film 3 are sterile at least in a delivery state and/or before use. The fixed connection formed in particular forms a sterile barrier. The drape film 3 separates at least the part of the holding device 10-2 surrounded by the drape film 3 from a sterile area of the treatment area.

It can be provided that the applicator arrangement 1 is packed in a blister pack upon delivery. In particular, the applicator arrangement 1 is packed in the blister after production and then sterilized in a manner known per se.

It can be provided that the drape film 3 is designed to be tubular at least in sections. A diameter of the hose shape can vary and, for example, be adapted to a shape of the holding device 10-2. In principle, the drape film 3 can also have a different shape. Areas with different shapes can also be provided.

The 2 shows a schematic representation to illustrate an embodiment of the applicator arrangement 1. The illustration shows a view from the direction of the (X-ray) radiation source 10-1 in the direction of the interface 2-1. In the embodiment shown, it is provided that the drape film 3 is perforated in the area of the fixed connection 4 with the interface 2-1, that is, has a recess 3-1, and the fixed connection 4 is on one, in particular around the recess 3 -1 circulating, outdoor area of interface 2-1 limited. There, the fixed connection 4 is formed, for example, by the drape film 3 being firmly connected in a connection area 4-1 to a surface of the interface 2-1, for example by an adhesive connection or a welded connection (for example by pressure welding or friction welding).

The 3a shows a further embodiment of the applicator arrangement 1. In the embodiment it is provided that the applicator 2 is arranged within the drape film 3, at least in a delivery state 20 of the applicator arrangement 1, so that the drape film 3 surrounds the applicator 2, such that an external one in the use state 21 Page 3-2 of the drape film 3 in the delivery state 20 points inwards towards the applicator 2 and access to the interface 2-1 is not covered by the drape film 3. Based on 3a , 3b and 3c The advantages and use of this embodiment of the applicator arrangement 1 are clarified. In the delivery state 20, the applicator 2 is arranged in the drape film 3, with the drape film 3 compared to the use state 21 (cf. 3c ) on the holding device 10-2 is pulled to the “left” (turned inside out), so that in the use state 21 (ie after arranging the drape film 3 around the holding device 10-2) on the outside side 3-2 of the drape film 3 inwards towards the Applicator 2 points. In this state, access to interface 2-1 is not covered by the drape film 3 ( 3a) . In this state, a user can manually grasp the applicator 2, insert a needle-shaped part 10-3 of the (X-ray) radiation source 10-1 through the interface 2-1 into the applicator 2 and connect the interface 2-1 to the (X-ray) Arrange radiation source 10-1. The drape film 3 can then be turned inside out in the direction of the holding device 10-2 (pulled to the “right”) and in this way pulled along the applicator 2 over the holding device 10-2 ( 3b) until the applicator 2 is no longer covered by the drape film 3 and the drape film 3 is completely pulled over the holding device 10-2 ( 3c ). In this way, the applicator arrangement 1 can be transferred to the use state 21. Finally, the drape film 3 can be fixed to the holding device 10-2, for example using straps 7 designed for this purpose (cf. 5 ) and/or elastic bands (not shown).

The 4 shows a schematic representation of another embodiment. In this embodiment it is provided that the applicator arrangement 1 has at least one machine-readable identification 5 with which the applicator arrangement 1 can be clearly identified. In the embodiment shown, the machine-readable identification 5 is arranged on a side of the drape film 3 that is remote from the applicator. Alternatively or additionally, such a machine-readable identification 5 can also be arranged on the applicator 2. The at least one machine-readable identifier 5 can be, for example, an RFID transceiver 5-1. Alternatively or additionally, the at least one machine-readable identifier 5 can also be an optically detectable identifier 5-2, for example a barcode or a QR code or another suitable code.

It can further be provided that the applicator arrangement 1 has at least one human-readable identification 6 with which the applicator arrangement 1 can be clearly identified. The human-readable identification 6 can, for example, include a unique serial number with which the applicator arrangement 1 can be clearly identified.

The 5 shows a schematic representation of an embodiment of the applicator arrangement 1 arranged on a holding device 10-2 of a radiation therapy device 10. The embodiment of the applicator arrangement 1 shown corresponds to that in the 4 embodiment shown. The same reference numbers designate the same features and terms. The drape film 3 is fixed to the holding device 10-2 with bands 7. The radiation therapy device 10 has at least one detection device 11, which reads the machine-readable identification 5 (and/or the human-readable identification 6). The detection device 11 is in particular arranged on a part of the radiation therapy device 10, which is arranged in the vicinity of the machine-readable identification 5 when the drape film 3 is arranged on the holding device 10-2 of the radiation therapy device 10. The detection device 11 can also be arranged in the non-sterile area. Depending on the design of the machine-readable identification 5, the identification or reading of the identification 5 takes place electromagnetically (e.g. by an RFID reader) and/or optically (e.g. by a camera or a photo sensor in the case of a barcode or a QR code or other code). The human-readable identification 6 can be detected in particular optically, for example by means of a camera.

In particular, it is provided that the at least one machine-readable identification 5 and/or the at least one human-readable identification 6 of the applicator arrangement 1 used is read out and/or recorded and/or registered in a database by means of the at least one detection device 11.

Furthermore, it is particularly provided that the read and/or recorded and/or registered identification 5, 6 is used to check whether the applicator arrangement 1 used has already been used. The checking can be carried out by means of the detection device 11 and/or by means of a control device (not shown) of the radiation therapy device 10. It can then be provided that, depending on a check result, an enable signal and/or a blocking signal are generated and provided, which enable and/or block operation of the (X-ray) radiation source 10-1. When checking, a database query can also be made to a database in which information about the use of applicator arrangements 1 is stored. The database can be provided both locally, for example in the detection device 11 or the control device, or on a central server.

The embodiments described above can also be designed in combination with one another.

It is furthermore provided in particular that an entirety of applicator arrangements 1 is intended for use. The entirety comprises a plurality of applicator arrangements 1 according to one of the described embodiments and/or according to a combination of the described embodiments. The applicator arrangements 1 are each individually identified within the entirety by a unique identification 5, 6. Within the entirety, the applicators 2 of the applicator arrangements 1, but also the drape films 3, can differ in size and/or shape and/or material, depending on the treatment location and/or treatment goal.

Reference symbol list

1

Applicator arrangement

2

applicator

2-1

interface

2-2

Area (sphere center)

3

Drape foil

3-1

recess

3-2

external side

4

stable connection

4-1

Connection area

5

machine-readable marking

5-1

RFID transceiver

5-2

optically detectable marking

6

human-readable labeling

7

tape

10

Radiation therapy device

10-1

(X-ray) radiation source

10-2

Holding device

10-3

needle-shaped part of the (X-ray) radiation source

11

Detection device

20

Delivery condition

21

Condition of use

Claims (15)

Applicator arrangement (1) for use in radiation therapy, comprising: an applicator (2) which is designed to be connected to an interface (2-1) designed for this purpose to be connected to a radiation source (10-1) of a radiation therapy device (10) and/or to at least partially accommodate the radiation source (10-1), and a drape film (3) for at least partially covering a holding device (10-2) of the radiation therapy device (10 ), whereby the drape film (3) is firmly connected to the applicator (2) in the area of the interface (2-1). Applicator arrangement (1). Claim 1 , characterized in that the applicator (2) and the drape film (3) are sterile. Applicator arrangement (1). Claim 1 or 2 , characterized in that the drape film (3) is at least partially tubular. Applicator arrangement (1) according to one of the preceding claims, characterized in that the drape film (3) is broken in the area of the fixed connection (4) with the interface (2-1) and the fixed connection (4) extends to an outer area of the interface (2-1) limited. Applicator arrangement (1) according to one of the preceding claims, characterized in that the applicator (2) is arranged within the drape film (3) at least in a delivery state (20) of the applicator arrangement (1), so that the drape film (3) covers the applicator (2 ) surrounds, in such a way that a side (3-2) of the drape film (3) which is on the outside in the use state (21) points inwards towards the applicator (2) in the delivery state (20) and access to the interface (2-1) is not possible is covered by the drape film (3). Applicator arrangement (1) according to one of the preceding claims, characterized by at least one machine-readable identification (5) with which the applicator arrangement (1) can be clearly identified. Applicator arrangement (1). Claim 6 , characterized by at least one RFID transceiver (5-1) arranged on the applicator (2) and/or the drape film (3), which forms and/or provides the at least one machine-readable identification (5). Applicator arrangement (1). Claim 6 or 7 , characterized by at least one identification (5-2) that can be optically detected on the applicator (2) and/or the drape film (3), which forms and/or provides the at least one machine-readable identification (5). Applicator arrangement (1) according to one of the preceding claims, characterized by at least one human-readable identification (6) with which the applicator arrangement (1) can be clearly identified. Applicator arrangement (1) according to one of the preceding claims, characterized in that the applicator arrangement (1) is packed in a blister. Set of applicator arrangements (1), comprising a plurality of applicator arrangements (1) according to one of Claims 1 until 10 , whereby the applicator arrangements (1) as a whole are each individually identified by a unique identification (5,6). Method for operating a radiation therapy device (10), wherein an applicator arrangement (1) according to one of Claims 1 until 10 is used, wherein the applicator (2) of the applicator arrangement (1) is arranged on a radiation source (10-1) of the radiation therapy device (10), and wherein the drape film (3) of the applicator arrangement (1) is wrapped around at least a part of the holding device (close to the applicator) 10-2) of the radiotherapy device (10) is arranged around. Procedure according to Claim 12 , characterized in that the applicator (2) is first arranged on the radiation source (10-1) of the radiation therapy device (10) and then the drape film (3) is placed along the applicator (2) over the part of the holding device (10-2) close to the applicator ) is drawn. Procedure according to Claim 12 or 13 , characterized in that at least one machine-readable identification (5) and/or at least one human-readable identification (6) of the applicator arrangement (1) used is read out and/or recorded and/or registered in a database by means of at least one detection device (11). Procedure according to Claim 14 , characterized in that the read and/or recorded and/or registered identification (5,6) is used to check whether the applicator arrangement (1) used has already been used.

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