The invention relates to a sensor cable for use with a brachy therapy system and to be used as a check cable in a pre-treatment verification step. The sensor cable performs a check function like obstruction detection, but also can determine channel swap, implant shift, perform reconstruction of implant etc.
In cancer treatment, brachytherapy can be applied interstitially, commonly through afterloading lumens inserted into the target volume. In high dose rate treatment, afterloading catheters are connected to an afterloader, so that a radioactive source can sequentially move to each dwell position inside the target area for a pre-planned dwell time. This process may take approximately 10-20 minutes. Other treatments may involve treatments with applicators that may remain longer in a patient's body, up to several days.
From EP3031494 a verification system is known that can confirm the position of a catheter or lumen inserted within the patient. It includes an elongate control element dimensioned for insertion within the lumen. In a typical brachytherapy treatment method, prior to treatment delivery, one or more lumens, including for example, a brachytherapy applicator, a needle, a tube, or a catheter, are positioned within a target treatment area. The lumen is connected to a source of treatment, and a radiotherapy source is delivered from the treatment source and through the lumen into the treatment area. The lumens are positioned within the patient to deliver the radiotherapy source to suitable, pre-determined treatment locations. The treatment source may be a mechatronic or computerized device (e.g., an afterloader), or the treatment may be delivered manually, and the radiotherapy source may either be a small X-ray generating device, a high dose-rate radioactive source, or a low dose-rate radioactive source for use with longer, shorter, or even permanent dwelling times within the patient.
To increase the effectiveness of brachytherapy, clinicians aim to administer an optimal dosage of radiotherapy source to the target tissue. Following diagnosis, brachytherapy treatment may include multiple stages. Imaging of the patient anatomy and disease anatomy (e.g., tumor location, size, shape, density, orientation) may be analyzed to determine the appropriate regions to administer treatment to. During a treatment preparation and/or planning stage, the desired placement, positioning, and orientation of one or more lumens to deliver the treatment to these target treatment regions may then be determined. Additionally, one or more dwell positions (i.e., locations where the radiotherapy source will remain for a period of time) within each lumen may be mapped in order to achieve a desired dose distribution. During these stages, lumens, which may take the form of an applicator (e.g., having one or more individual lumen channels), needles, tubes, or catheters, may be inserted into a patient, and imaging may be used to confirm the position of the lumens. Next, during a treatment delivery stage, one or more radiotherapy sources may be delivered to the lumens, and the patient may undergo radiation treatment.
Movement or misalignment of one or more lumens may affect the amount of radiation treatment delivered to the target tissue. Misalignment could cause delivery of treatment to the wrong area or delivery of the wrong dosage of treatment to the target area which could arise especially in a treatment procedure that takes longer time, or in which multiple treatments are prescribed over longer time periods. In addition organ swelling may affect the accuracy of lumen positioning. Yet, there is often no convenient way to verify positioning of the lumens after the treatment preparation/planning stage to confirm that the treatment will be delivered as planned.
For example, an applicator may be inserted into a patient for treatment planning, and medical imaging may be used to assess positioning of the lumens. Based on this information, a healthcare provider may determine the location of the dwell positions. Imaging and/or tracking devices and/or processing software may be used to assist with the treatment planning based on the location of the applicator within the body. Once treatment preparation and planning are complete, the patient may be moved into a different room for treatment delivery or otherwise prepared for treatment delivery. The treatment delivery room may include shielding to accommodate use of radioactive materials and may not be compatible with the imaging and/or tracking devices used during treatment planning.
For example, it is important to connect the transfer tube to the correct channel and applicator channel/catheter to assure that the source will be positioned in the intended channel. It would be preferable if channel mapping can be performed automatically.
Also, it would be preferable if a reconstruction of the channel path can be based on imaging performed before the treatment, to define the source path in relation to the target. A treatment plan may be made by automatic reconstruction (contouring) of the catheters/applicator lumens, which is used to calculate dwell positions and times.
Furthermore, it would be preferable if a control system is able to determine if the implant (applicator/catheter) remains at intended positions during the complete treatment, e.g. that may detect shifts of the implanted applicator e.g. due to movement of the patient. These types of treatment may be performed with having multiple treatment channels, wherein at the same time one channel may be checked for starting the radiation treatment, while a next channel may be checked for having a proper position, prior to starting the radiation treatment.
The treatment delivery system (e.g., afterloader) may determine radiotherapy source positioning based on indirect measurements, such as the predetermined dwell positions, saved imaging data, the length of the lumens, the distance that the source has been inserted into the lumens, and the connection of transfer tubes to the lumens. Yet, inaccuracies may occur when relying on secondary measurements. For example, any snaking, bunching, or slack that may be created as a wire with a source or sensor is fed into the lumen may result in inaccurate determinations of how far the source or sensor has been inserted and where in the lumen it is located. Thus, following insertion of the lumen into the body for treatment planning purposes, the lumen may shift within the body, and current systems may not be able to directly determine spatial positioning of the lumen. Consequently, current systems may be unable to directly or accurately verify the ultimate location of the radiotherapy source when delivered to the lumen. Shifting of the lumen after the imaging during treatment planning or preparation may go undetected, resulting in inaccurate radiation treatment for the patient.
It is an object of the present invention to further advance the field of sensor cable devices for use in a brachytherapy afterloader to address these and other challenges.
According to one aspect, a brachytherapy sensor cable is provided to be used in a brachy therapy treatment, comprising a hollow conduit in a proximal part of the sensor cable, so that the sensor cable can be moved through a lumen towards an applicator positioned in a human body and wherein a distal part of the sensor cable comprises a sensor; wherein a hollow passage is formed between the proximal part and the distal part to guide signal wiring of the sensor through the hollow conduit of distal part and proximal part. In an embodiment, the signal wiring is guided towards a connector that is connectable to the afterloader system; where it is noted that in using the term ‘afterloading system’ the sensor cable may be used in a verification device separate from an afterloader device, that contains the radio-active source. Such a separate device could perform the actions of verification and planning separately from the afterloader having the radioactive source, which thereby could improve the treatment logistics, since the pretreatment step could be carried out in a separate room with less safety precautions. Such variations are deemed to be encompassed by the scope of the present claims.
It is noted that the term sensor may be used for signal detection, e.g. of an external field, such as an electromagnetic field, or any other field that can be used for the purpose of tracking a treatment path for providing brachytherapy treatment in patient's tissue to be treated. Examples may be measurement of position, radiation, advanced length within the lumen.
The device according to the invention may enable automatic mapping of a channel source path, so that channel swaps can be prevented. Furthermore channel mapping and reconstruction can be provided using the sensor data of the sensor cable and problems due to implant shifts swelling, that could cause a change to the source path can be automatically identified. The sensor is preferably an electromagnetic tracking device, so that no additional ionization radiation is involved. The sensor may additionally be able to detect reference points such as reference marker rings in applicators or markers that identify transfer tube couplings.
The invention will be further elucidated in the figures:
Aspects of the invention pertain a brachytherapy sensor cable for connection to a brachytherapy afterloader system to be used in a brachy therapy treatment. The sensor cable comprises a hollow conduit. A proximal part of the sensor cable is connectable to an afterloader system, so that the sensor cable can be moved through a lumen towards an applicator positioned in a human body. A distal part of the sensor cable comprises a sensor; a hollow passage is formed between the proximal part and the distal part to guide signal wiring of the sensor through the hollow conduit of distal part and proximal part towards a connector that is connectable to the afterloader system. In an embodiment the hollow conduit is formed of helical strands.
A proximal part may have a different rigidity to the distal part. At least one of the proximal part and the distal part may comprise a hollow conduit of helical threads. Rigidity is matched to lateral bending stiffness, as flexural rigidity which may be regarded as the is resistance of a conduit against bending deformation.
The helical strands are preferably formed with a stiffness of a first magnitude for the proximal part of the cable; and with a stiffness of a second magnitude, lower than the first magnitude, for the distal part of the hollow conduit. In this way the sensor tip can be moved more flexibly through the brachytherapy channel path which may have a small curvature. This enhances the reliability of the sensor location, since it may be reproduced more easily without shifting of the sensor cable due to snaking. Furthermore, the proximal part may be rendered relatively stiffly, so it can withstand the friction force that will increase towards the proximal position, due to the increased contact of the sensor cable with the conduit wherein it moves.
In order to provide a different flexibility helical strands of proximal part and distal part of the hollow conduit may differ in number. Alternatively or additionally, the number of strands of the distal portion is higher than the number of strands of the proximal part; wherein an increased number of strands may render a more flexible distal portion. In another aspect, the angle or pitch of the helical winding may vary, where a small angle may have an increased rigidity relative to a large angle. The invention is not limited to helical strands but may include strands that are parallel to the cable axis. In a preferred embodiment, the strands are welded together in a metal bushing.
Alternatively or additionally, in order to optimize a desired flexibility characteristic of the hollow sensor cable, the helical strands of proximal part and distal part of the hollow conduit may differ in cross sectional form. For example, a cross sectional form of at least the proximal part may be oblate, to increase the friction force between the strands and thereby increasing the stiffness of at least the lower cable. By suitable combination, the cable can be tuned to have the exact flexibility characteristics of a check cable without a sensor; which check cables are known components that are used to test the clearance of the conduits, before actual administration of the brachy therapy treatment.
A hollow passage may be formed by a weld that connects at least some of the helical strands from the distal part to the proximal part of the cable. In another aspect, the sensor may be a 5-DOF position sensor, i.e. the sensor may have five degrees of freedom.
In yet a further aspect, the sensor is provided in a bushing fixed within to the distal part. In certain embodiments, the sensor comprises a coil that extends in part from the bushing in proximal direction.
A further aspect of the invention pertains to brachytherapy control system, to be coupled to a brachytherapy sensor cable according to any previous claims. The control system may be programmed to process input data from the sensor, to create a three-dimensional channel path profile of a treatment path for providing brachytherapy treatment in patient's tissue to be treated. Furthermore, a treatment and a treatment planning module may be provided for calculating a Biological Effective Dose for brachytherapy treatment, based on the actual registered three-dimensional channel path profile from the sensor registration, of a treatment path for providing brachytherapy treatment in patient's tissue to be treated.
In a further aspect the brachytherapy control system has a treatment planning module provided with:
While in the following description, the invention is embodied with a conduit of helical strands, the invention is not limited to that form but could be carried out with alternative flexible hollow conduit designs, that having a stiffness characteristic that makes them suitable for a brachytherapy sensor cable. For instance the conduit may be formed of braided cable sleeves, or coated flexible conduits, eg helical fibers or strips. Additionally, different material will result in different stiffness characteristic (for example, stainless steel, titanium or nitrol will have varying the stiffness characteristics. Also the number of filars of the hollow helical strand tube will influence stiffness characteristics (higher number of filars gives higher flexibility/lower stiffness).
Now turning to
In more detail,
Bushing 118 is a strain relief which prevents fatigue (breaking of laser weld) due to flexing of distal tip when cable is moved through applicator curvatures. Same is applicable for bushing 171 in
To optimize the robustness and use in the imaging environment, which may be a scanner with a high magnetic field strength e.g. >2 T suitable materials may be stainless steel and polymer, e.g. PEEK, Polyimide to not disturb the sensor signal e.g. by ferromagnetic materials. Because the sensor cable may be held close to a radioactive source, parts of the cable may have to withstand gamma radiation. This is in particular relevant for the sensor consisting of coil, core, potting, shrink tube and twisted pair. Such a radiative transit dose may be received by the cable when it moves beside the radioactive source, but also in stored situation in safe. And for scenario when sensor cable steps through applicator while other lumen is used to irradiate the target.
This passage 170 is thereby able to have an electrical lead guided through the conduit 165 while having a mechanical characteristic of a conventional brachytherapy wire cable, that advances a radiation source through a lumen, or that advances a ‘dummy’ through the lumen, and that is equally flexible on both proximal and distal parts, thus providing an optimal balance between prevention ‘snaking’, necessary for allowable distance measurement and smooth advancement and flexibility of the tip, also necessary for smooth advancement especially when the lumens for brachytherapy treatment have some bending radius.
In the remainder,
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During the treatment control stage, treatment planning may occur, and the precise dose distribution and dwell positioning may be mapped out, based on the positioning of the conduits relative to the patient anatomy. During treatment execution, treatment may be delivered via the conduits, and treatment verification may occur before, during, and/or after treatment delivery. Though the embodiment of
As is shown in
It is thus believed that the operation and construction of the present invention will be apparent from the foregoing description and drawings appended thereto. For the purpose of clarity and a concise description, features are described herein as part of the same or separate embodiments, however, it will be appreciated that the scope of the invention may include embodiments having combinations of all or some of the features described.
The sensor cable may applied wherever HDR-BT or PDR-BT is considered a beneficial procedure to apply ionising radiation in the process of cancer treatment. Among others: Prostate Cancer, Glioblastoma Multiforme cancer treatment, Gynaecological cancer treatment, Rectal cancer treatment, Breast cancer treatment, Head & Neck cancer treatment, etc.
It will be clear to the skilled person that the invention is not limited to any embodiment herein described and that modifications are possible which may be considered within the scope of the appended claims. Also kinematic inversions are considered inherently disclosed and can be within the scope of the invention. In the claims, any reference signs shall not be construed as limiting the claim. The terms ‘comprising’ and ‘including’ when used in this description or the appended claims should not be construed in an exclusive or exhaustive sense but rather in an inclusive sense. Thus expression as ‘including’ or ‘comprising’ as used herein does not exclude the presence of other elements, additional structure or additional acts or steps in addition to those listed. Furthermore, the words ‘a’ and ‘an’ shall not be construed as limited to ‘only one’, but instead are used to mean ‘at least one’, and do not exclude a plurality. Features that are not specifically or explicitly described or claimed may additionally be included in the structure of the invention without departing from its scope. Expressions such as: “means for . . . ” should be read as: “component configured for . . . ” or “member constructed to . . . ” and should be construed to include equivalents for the structures disclosed. The use of expressions like: “critical”, “preferred”, “especially preferred” etc. is not intended to limit the invention. To the extent that structure, material, or acts are considered to be essential they are inexpressively indicated as such. Additions, deletions, and modifications within the purview of the skilled person may generally be made without departing from the scope of the invention, as determined by the claims.
Number | Date | Country | Kind |
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2029601 | Nov 2021 | NL | national |
Filing Document | Filing Date | Country | Kind |
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PCT/NL2022/050617 | 11/2/2022 | WO |