Medical applicator

The modular brachytherapy applicator system addresses the challenge of patient-specific anatomical variability by allowing customizable assembly and precise radiation delivery, enhancing treatment accuracy and comfort through interchangeable components and adjustable configurations.

WO2025262317A1PCT designated stage Publication Date: 2025-12-26NUCLETRON OPERATIONS
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Patent Information

Application Number
PCT/EP2025/067449
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-06-21
Filing Date
2025-06-20
Publication Date
2025-12-26

AI Technical Summary

Technical Problem

Current brachytherapy applicators are not adequately adaptable to the unique anatomical and treatment needs of individual patients, requiring hospitals to maintain a large inventory of different types to accommodate various patients, and even then may not achieve optimal radiation source positioning.

Method used

A modular applicator system comprising a tubular central body and interchangeable components, allowing for customizable assembly based on patient-specific anatomy and treatment needs, with features like angled needle channels and adjustable configurations for precise radiation delivery.

Benefits of technology

Enables personalized treatment plans with improved anatomical fit, reduced air gaps, enhanced patient comfort, and accurate dose delivery by allowing for a wide range of radiation source positioning options.

✦ Generated by Eureka AI based on patent content.

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Abstract

Disclosed herein is a kit for a modular applicator, the applicator being suitable for delivering brachytherapy treatment. The kit comprising an elongate central body comprising a first alignment structure on its outer surface and extending along at least a part of its length, and a plurality of components each comprising a central opening through which the elongate central body can pass. The plurality of components comprise a first component configured to be positioned at a distal end of the elongate central body and a second component configured to be positioned on the elongate central body adjacent to the first component. Wherein each of the first and the second component comprises a second alignment structure positioned on an inner surface of the respective central opening and wherein interaction of the first alignment structure of the elongate central body with the second alignment structure of each of the first and second component brings the first and second component into a preferred orientation with respect to one another on the elongate central body.
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Description

[0001] Medical applicator

[0002] This disclosure relates to a medical applicator for cancer treatment, and in particular to applicators suitable for enabling treatment of cancers which affect the female reproductive system via brachytherapy.

[0003] Background

[0004] Brachytherapy is a form of radiation therapy used to treat various types of cancer. It involves the placement of radioactive sources, known as "seeds" or "implants," in or near the tumor site to deliver a targeted dose of radiation. During brachytherapy, the radiation sources are typically placed directly inside the body, either temporarily or permanently, depending on the treatment plan. The radioactive sources emit high-energy radiation, such as gamma rays or X-rays, which damage the DNA of cancer cells, inhibiting their ability to grow and divide. The goal is to deliver a high dose of radiation directly to the tumor while minimizing the exposure to surrounding healthy tissues.

[0005] There are two primary types of brachytherapy: interstitial (IS) and intracavitary (IC). In interstitial brachytherapy, the radiation sources are inserted directly into the tissue surrounding the tumor. This may involve the use of thin needles or catheters to deliver the seeds, ensuring they are properly positioned. This method is commonly used for prostate, breast, head and neck, and gynecological cancers. In intracavitary brachytherapy, the radiation sources are placed within a body cavity close to the tumor site. This is often used for cancers located in hollow organs, such as the uterus, cervix, vagina, esophagus, or bronchial tree. The specific application of brachytherapy depends on the type, size, and location of the tumor(s), as well as the overall health of the patient.

[0006] Brachytherapy applicators are specialized devices used to position and hold the radioactive sources in place. Current systems utilize applicators that consist of tubes which serve as guides for directing the radiation sources to the desired treatment sites. Applicator shape, size, and functionality differ greatly according to the type of cancer the applicator is intended to treat. To provide an example: endometrial and vaginal cancers are examples of cancers which can affect the female reproductive system. Currently, a brachytherapy applicator particularly suited for treating endometrial cancer is very different to an applicator suitable for treating primary vaginal cancer. Even within the same general category of cancer, each patient and each tumour is different. To account for differences in tumour position, shape and placement; patient anatomy; cancer type; and other treatment needs, a hospital must own a large number of brachytherapy applicator types in order to provide its clinicians with the range of options they need to provide effective treatment to a range of patients. Even with a large number of options, it still may not be possible to position the radiation source(s) in optimal positions as required by the particular patient's tumour placement and shape, and their anatomy.

[0007] The present invention seeks to address these and other disadvantages encountered in the prior art by providing an improved medical applicator for radiotherapy.

[0008] Summary

[0009] One or more inventions are set out in the claims.

[0010] Figures

[0011] Specific embodiments are now described, by way of example only, with reference to the drawings, in which:

[0012] Figure 1 depicts a modular applicator according to the present disclosure;

[0013] Figures 2a-d depicts options for central tubes and components which may make up modular applicators in accordance with the present disclosure;

[0014] Figures 3a-f depict modular applicators according to the present disclosure;

[0015] Figure 4 depicts dose profile and possible needle placements using modular applicators according to the present disclosure;

[0016] Figures 5a-l depict mechanisms via which modular applicators can be assembled and held together in accordance with the present disclosure;

[0017] Figure 6 depicts example central tubes according to the present disclosure, in particular those which are suitable for treating endometrial cancer;

[0018] Figure 7 depicts a modular applicator according to the present disclosure;

[0019] Figures 8a-d depict modular applicators according to the present disclosure;

[0020] Figures 9a-g depict possible needle placements using applicators according to the present disclosure.

[0021] Figures lOa-e depict shapes for cuff segments according to the present disclosure;

[0022] Figure 11 depicts a modular applicator according to the present disclosure;

[0023] Figures 12a, 12b depict a needle locking mechanism according to the present disclosure;

[0024] Figure 13 depicts example recommended applicators for particular treatment needs;

[0025] Figure 14 depicts a computer-implemented method according to the present disclosure;

[0026] Figure 15 depicts a system according to the present disclosure;

[0027] Figure 16 depicts an example computer readable media according to the present disclosure.

[0028] Figures 17a-b depict options for components which may make up modular applicators in accordance with the present disclosure; Figure 18a depicts a mechanism via which modular applicators can be assembled and held together according to the present disclosure;

[0029] Figure 19 depicts a modular applicator according to the present disclosure;

[0030] Figures 20a-b depict mechanisms via which modular applicators can be assembled and held together in accordance with the present disclosure;

[0031] Figure 21 depicts a modular applicator according to the present disclosure;

[0032] Figures 22a-b depict options for components which may make up modular applicators in accordance with the present disclosure;

[0033] Figures 23a-b depict modular applicators according to the present disclosure;

[0034] Figures 24a-c depict options for components which may make up modular applicators in accordance with the present disclosure;

[0035] Figures 24d-e depict mechanisms via which modular applicators can be assembled and held together in accordance with the present disclosure;

[0036] Figures 25a-c depict modular applicators according to the present disclosure;

[0037] Figure 26 depicts an example central tube according to the present disclosure;

[0038] Figures 27a-c depict mechanisms via which needles and catheters can be held in an applicator according to the present disclosure;

[0039] Figure 28 depicts a modular applicator according to the present disclosure;

[0040] Figure 29 depicts a method according to the present disclosure;

[0041] Detailed Description

[0042] In overview, and without limitation, the application discloses a medical applicator suitable for brachytherapy. The applicator is 'modular' and can be assembled from any of a plurality of different components, each with different lengths, sizes, shapes, and features in order to optimise the assembled applicator for a large number of potential treatment needs. In this way, the application further relates to a kit for a modular applicator. The kit comprises components which can be assembled to produce an applicator, for example an applicator suitable to deliver brachytherapy treatment and which is sized and otherwise suitable for a particular patient and their anatomy.

[0043] Disclosed herein is a kit for a modular applicator, the applicator being suitable for delivering brachytherapy treatment. The kit comprises a tubular central body comprising a seed passage channel to enable passage of a radioactive seed therethrough, at least one component comprising an opening through which the tubular central body can pass and means for detachably attaching the at least one component to the tubular central body. Optionally, the at least one component comprises a plurality of needle channels, each needle channel configured to guide an interstitial needle. Optionally, at least one of the plurality of needle channels is configured to guide a needle to form an angle offset from, and oblique to, the seed passage channel. Optionally, the at least one of the plurality of needle channels is configured to guide a needle parallel to the seed passage channel. Optionally, the at least one component is a 3d printed component, wherein the 3d printed component is shaped to fit a specific patient's anatomy. Optionally, the at least one component is a cuff segment configured to be positioned at a distal end of the tubular central body. Optionally, the cuff segment comprises an offset frustoconical shape. Optionally, the cuff segment flares outward toward its outer rim. Optionally, the at least one component comprises a plurality of components, each comprising a respective opening through which the tubular central body can pass.

[0044] Optionally, one of the plurality of components is a cuff segment configured to be positioned at a distal end of the modular applicator, wherein another one of the plurality of components is a paravaginal component configured to be positioned alongside the cuff segment in use, wherein both the cuff segment and paravaginal component comprise a plurality of needle channels positioned such that, in use, one or more needles can pass through both the paravaginal component and the cuff segment.

[0045] Optionally, both the cuff segment and the paravaginal component comprise needle channels configured to guide a needle to form an angle offset from, and oblique to, the seed passage channel. Optionally, the tubular central body comprises a recess on its outer surface and along at least a majority of its length, and the at least one component comprises a corresponding ridge positioned on an inner surface of the opening, such that, by interaction of the recess and ridge, the at least one component is guided onto the tubular central body in a particular orientation.

[0046] Optionally, the tubular central body comprises an intrauterine portion configured, in use, to enter the patient's uterus, wherein the intrauterine portion comprises a plurality of tubes, each configured to receive a radioactive seed via the seed passage channel.

[0047] Optionally, each tube of the plurality of tubes is biased away from a central axis defined by the seed passage channel, wherein the tubular central body further comprises a slidable sheath configured to slide over the intrauterine portion and thereby bring the plurality of tubes together. Optionally, the at least one component is configured to removably attach to the slidable sheath.

[0048] Optionally, one or more tubes of the plurality of tubes are opened ended such that a flexible catheter may pass through the seed passage channel, through the tube, and extend out from the open end of the one or more tubes.

[0049] Disclosed herein is a modular applicator comprising a tubular central body comprising a seed passage channel to enable passage of a radioactive seed therethrough, at least one component comprising an opening through which the tubular central body is passed pass and means for detachably attaching the at least one component to the tubular central body.

[0050] Optionally, the modular applicator is assembled from the kit.

[0051] Disclosed herein is a computer-implemented method of generating an optimal applicator configuration, the applicator being suitable for treating a patient via brachytherapy. The method comprises receiving information regarding treatment needs of the patient and outputting, based on the received information, an optimal applicator configuration for the patient's brachytherapy treatment, wherein the optimal applicator configuration comprises a recommended tubular central body selected from a plurality of tubular central body options, and at least one recommended component for attaching to the central tubular body selected from a plurality of component options.

[0052] Optionally, the information regarding the treatment needs of the patient may comprise one or more of: information regarding the location, orientation, and shape of one or more tumours; information regarding the location, orientation, and shape of one or more organs at risk (OARs); information regarding the type of cancer and / or the cancer diagnosis; one or more medical images depicting the patient anatomy; medical information associated with the patient; and / or dose information as prescribed by a clinician or in accordance with an existing treatment plan.

[0053] Optionally, outputting, based on the received information, the optimal applicator configuration comprises using a trained machine learning model. The method further optionally comprising generating a brachytherapy treatment plan based on the received information, wherein the treatment plan comprises using the optimal applicator.

[0054] Disclosed herein is a system configured to perform any method described and disclosed herein, including the method described in the above clauses.

[0055] Disclosed herein is a kit for a modular applicator, the applicator being suitable for delivering brachytherapy treatment. The kit comprises an elongate central body comprising a first alignment structure on its outer surface and extending along at least a part of its length and a plurality of components each comprising a central opening through which the elongate central body can pass. The plurality of components comprise a first component configured to be positioned at a distal end of the elongate central body and a second component configured to be positioned on the elongate central body adjacent to the first component. Each of the first and the second component comprises a second alignment structure positioned on an inner surface of the respective central openings, wherein interaction of the first alignment structure of the elongate central body with the second alignment structure of each of the first and second component brings the first and second component into a preferred orientation with respect to one another on the elongate central body.

[0056] Optionally, the elongate central body comprises at least one passage to enable passage of a radioactive seed therethrough. Optionally, the at least one passage is a plurality of passages, each configured to enable passage of a radioactive seed therethrough. Optionally, the at least one passage is configured to guide a needle or catheter therethrough. Optionally, the needle or catheter is configured to enable passage of the radioactive seed therethrough.

[0057] Optionally, the kit further comprises at least one catheter, each catheter comprising a collar on its outer surface, wherein the collar is positioned at a first predetermined distance from a distal end of the catheter and provides a region of catheter having an increased diameter. Optionally, wherein the collar is resiliently collapsible. Optionally, wherein the at least one passage comprises a region of increased diameter at a second predetermined distance from a distal end of the elongate central body, the second predetermined distance being less than the first predetermined distance.

[0058] Optionally, the catheter and at least one passage are configured such that, during insertion of the catheter into the at least one passage, the collar is resiliently deformed to enable traversal of the catheter through the at least one passage until the collar reaches the region of increased diameter within the at least one passage, thereby enabling the collar to expand within the region of increased diameter and provide resistance to further traversal of the catheter through the at least one channel.

[0059] Optionally, the first alignment structure extends in a direction parallel with a central axis of the elongate central body.

[0060] Optionally, the elongate central body further comprises an end stopper located at a distal end of the elongate central body, wherein the end stopper is configured to engage the first component.

[0061] Optionally, the first alignment structure comprises a ridge and the second alignment structure of each of the first and second component comprises a recess, wherein the recesses are configured to interact with the ridge of the first alignment structure such that the first and second components are brought into the preferred orientation with respect to one another on the elongate central body.

[0062] Optionally, the recess of the first component is elongated in a direction of a central axis of the first component, and the recess of the second component is elongated in a direction of a central axis of the second component, wherein the central axes of the elongate central body, first component, and second component are aligned when the applicator is assembled.

[0063] Optionally, the recess of the first component is a multi-level recess, wherein the muti-level recess comprises an alignment portion and an engagement portion, the engagement portion being recessed to a greater degree than the alignment portion.

[0064] Optionally, the ridge comprises a multi-level ridge comprising an alignment portion and an engagement portion, the engagement portion extending outward from the elongate central body to a greater degree than the alignment portion, and wherein the engagement portion of the multi level ridge is configured to engage with the engagement portion of the multi-level recess.

[0065] Optionally, the first component and the second component each comprise at least one needle channel. Optionally, wherein the at least one needle channel in the first component and the at least one needle channel in the second component align when the first component and the second component are brought into the preferred orientation. Optionally, wherein, when the first component and second component are in the preferred orientation, a needle may be passed through the at least one needle channel in the first component and the at least one needle in the second component. Optionally, wherein the at least one needle channel of the first and second component is configured to guide the needle substantially parallel to a central axis of the elongate central body. Optionally, the at least one needle channel in the first component and / or the at least one needle in the second component is configured to guide the needle to form an angle offset from, and oblique to, a central axis of the elongate central body. Optionally, wherein guiding the needle to form an angle offset from, and oblique to, the central axis comprises guiding the needle to extend out from an outer surface of the first or second component.

[0066] Optionally the plurality of components further comprises one or more extension components, wherein the one or more extension components are each configured to be positioned on the elongate central body. Optionally, wherein each of the one or more extension components comprises a second alignment structure positioned on an inner surface of its central opening, wherein interaction of the first alignment structure of the elongate central body and the second alignment structure of an extension component brings the extension component into the preferred orientation

[0067] Optionally, the one or more extension components each comprise at least one needle channel, wherein the at least one needle channel in the extension components is configured to align with the at least one needle channel in the first and second components respectively when each of the first component, the second component and the one or more extension components are positioned in the preferred orientation.

[0068] Optionally, the plurality of components further comprises a perineal template component comprising a substantially planar plate, the substantially planar plate comprising a plurality of apertures each configured to guide a needle therethrough. Optionally, wherein, when the perineal template component is positioned on the elongate central body, the perineal template component extends radially out from the elongate central body such that the plate extends substantially perpendicular to a central axis of the elongate central body. Optionally, wherein each of the apertures of the perineal template component is configured to guide a needle parallel to the central axis of the elongate central body. Optionally, wherein when the perineal template component is positioned on the elongate central body, the apertures of the plurality of apertures are arranged around the elongate central body. Optionally, at least one of the second component and the one or more extension components comprises third alignment structure located on an outer surface and the perineal template component comprises fourth alignment structure located on an inner surface of the central opening of the perineal template component. Wherein interaction of the third alignment structure of the second component or extension component and the fourth alignment structure of the perineal template component brings the component into a preferred orientation with respect to one another on the elongate central body.

[0069] Optionally, the kit further comprises a fixation element comprising a central opening through which the elongate central body can pass, the fixation element configured to fix the plurality of components in place with respect to the elongate central body.

[0070] Optionally, wherein the first alignment structure further comprises one or more notches positioned at fixed intervals along at least of the length of the elongate central body and wherein the fixation element comprises a wedge located on an inner surface of its central opening, the wedge configured to interact with one of the one or more notches of the first alignment structure.

[0071] Optionally, the elongate central body comprises an intrauterine portion configured, in use, to enter the patient's uterus, wherein the intrauterine portion is configured to receive a radioactive seed via the at least one passage.

[0072] Optionally, the kit further comprises a plurality of options for the first component, each having a different diameter, a plurality of options for the second component, each having one of the different diameters.

[0073] Disclosed herein is a modular applicator suitable for delivering brachytherapy treatment, the applicator comprises an elongate central body comprising a first alignment structure on its outer surface and extending along at least a part of its length and a plurality of components affixed to the elongate central body, each comprising a central opening. Wherein the elongate central body is positioned through the central opening of each of the plurality of components and the plurality of components comprise a first component positioned at a distal end of the elongate central body and a second component positioned on the elongate central body adjacent to the first component.

[0074] Wherein each of the first and second component comprises a second alignment structure positioned on an inner surface of the respective central openings and wherein interaction of the first alignment structure of the elongate central body with the second alignment structure of each of the first and second component defines a preferred orientation of the first and second component with respect to one another on the elongate central body.

[0075] Optionally, the modular applicator is assembled from the kit.

[0076] Disclosed herein is a method of assembling a modular applicator, the applicator suitable for delivering brachytherapy treatment. The method comprises selecting an elongate central body from a plurality of elongate central bodies, wherein the elongate central body comprises a first alignment structure located on its outer surface and extending along at least a part of its length. The method further comprising selecting a first component from a plurality of components, wherein each of the plurality of components comprises a central opening through which the elongate central body can pass, positioning the first component at a distal end of the elongate central body, selecting a second component from the plurality of components and positioning the second component on the elongate central body adjacent to the first component. Wherein each of the first component and the second component comprises a second alignment structure positioned on an inner surface of the respective central openings, and wherein interaction of the first alignment structure of the elongate central body with the second alignment structure of each of the first and second component brings the first and second component into a preferred orientation with respect to one another on the elongate central body. The method further comprises bringing the first and second component into the preferred orientation on the elongate central body.

[0077] Optionally the method further comprising selecting one or more extension components from the plurality of components, positioning the one or more extension components on the elongate central body adjacent to the second component and bringing the one or more extension components into the preferred orientation on the elongate central body.

[0078] Optionally, the method further comprising selecting a perineal template component from the plurality of components and positioning the selected perineal template component over the elongate central body. Optionally, the method further comprising positioning a fixation element over the elongate central body to affix the position of the selected plurality of components with respect to the elongate central body.

[0079] Disclosed herein is a kit for a modular applicator, the applicator being suitable for delivering brachytherapy treatment. The kit comprises an elongate central body and a plurality of components each comprising a central opening through which the elongate central body can pass. The plurality of components comprises a first component configured to be positioned at a distal end of the elongate central body and a second component configured to be positioned on the elongate central body adjacent to the first component, wherein at least one of the first and second component comprises at least one angled needle channel, the at least one angled needle channel being configured to guide a needle out from the component at an angle oblique to a central axis of the elongate central body.

[0080] Optionally, wherein the elongate central body comprises at least one passage to enable passage of a radioactive seed therethrough. Optionally, wherein the at least one passage is a plurality of passages, each configured to enable passage of a radioactive seed therethrough. Optionally, wherein the first and the second component each further comprise at least one further needle channel, the at least one further needle channel being configured to guide a needle parallel to the central axis of the elongate central body.

[0081] Optionally, the at least one further needle channel is positioned radially closer to the central axis than the at least one angled needle channel.

[0082] Optionally, the plurality of components further comprises one or more extension components, wherein the one or more extension components are each configured to be positioned on the elongate central body.

[0083] Optionally, at least one of the one or more extension components comprises at least one angled needle channel, the at least one angled needle channel being configured to guide a needle out from the at least one extension component at an angle oblique to a central axis of the elongate central body.

[0084] Optionally, the one or more extension components further comprise at least one further needle channel, the at least one further needle channel of each of the one or more extension components respectively being configured to guide a needle parallel to the central axis of the elongate central body.

[0085] Optionally, the kit further comprises a fixation element configured to be positioned on the elongate central body, the fixation element being configured to secure the plurality of components with respect to the elongate central body.

[0086] Optionally, the elongate central body comprises a first alignment structure on its outer surface that extends along at least a part of its length and each of the first and the second component comprises a second alignment structure positioned on an inner surface of their central openings. Wherein interaction of the first alignment structure of the elongate central body with the second alignment structure of each of the first and second component brings the first and second component into a preferred orientation with respect to one another on the elongate central body.

[0087] Optionally, the first component comprises the at least one angled needle channel and the second component comprises a corresponding needle channel configured to guide a needle parallel to the central axis of the elongate central body. Wherein, when the first and second component are in the preferred orientation, the corresponding needle channel aligns with the at least one angled needle channel such that a needle may be passed through the corresponding needle channel in the second component, into the angled needle channel of the first component, and out from the first component at the angle oblique to the central axis.

[0088] Optionally, the at least one angled needle channel is a plurality of angled needle channels, the plurality of needle channels being arranged around the central axis, wherein the second component comprises a plurality of corresponding needle channels arranged such that, when the first and second component are in the preferred orientation, each of the angled needle channels in the first component aligns with a corresponding needle channel of the plurality of corresponding needle channels, such that a plurality of needles may be passed through the second component, into the first component, and out from the first component at an angle oblique to the central axis.

[0089] Optionally, the kit further comprises a plurality of options for the first component. The plurality of options comprise a first option component comprising a first angled needle channel configured to guide a needle out from the first option component at a first angle oblique to the central axis of the elongate central body, and a second option component comprising a second angled needle channel configured to guide a needle out from the second option component at a second, different angle oblique to the central axis.

[0090] Disclosed herein is a modular applicator suitable for delivering brachytherapy treatment, the applicator comprising an elongate central body and a plurality of components affixed to the elongate central body, each comprising a central opening, wherein the elongate central body is positioned through the central opening of each of the plurality of components. The plurality of components comprising a first component configured to be positioned at a distal end of the elongate central body and a second component configured to be positioned on the elongate central body adjacent to the first component. Wherein at least one of the first and second component comprises at least one angled needle channel, the at least one angled needle channel being configured to guide a needle out from at least one of the first and second component at an angle oblique to a central axis of the elongate central body.

[0091] Optionally, the modular applicator further comprises the needle positioned within the at least one angled needle channel.

[0092] Optionally, wherein the modular applicator is assembled from the kit.

[0093] Disclosed herein is a method of assembling a modular applicator, the applicator suitable for delivering brachytherapy treatment, the method comprising selecting an elongate central body from a plurality of elongate central bodies, selecting a first component from a plurality of components, wherein each of the plurality of components comprises a central opening through which the elongate central body can pass, positioning the first component at a distal end of the elongate central body, selecting a second component from the plurality of components and positioning the second component on the elongate central body adjacent to the first component. Wherein at least one of the first and second component comprise at least one angled needle channel, the at least one angled needle channel being configured to guide a needle out from at least one of the first and second component at an angle oblique to a central axis of the elongate central body.

[0094] Optionally, the method further comprising positioning a needle through the at least one angled needle channel. Disclosed herein is a kit for a modular applicator, the applicator being suitable for delivering brachytherapy treatment, the kit comprising an elongate central body and a plurality of components each comprising a central opening through which the elongate central body can pass. The plurality of components comprise a first component configured to be positioned at a distal end of the elongate central body, a perineal template component comprising a plurality of needle apertures, each aperture being configured to guide a needle therethrough and a plurality of extension components, each extension component being configured to be positioned on the central elongate body such that a variable number of extension components may be positioned between the first component and the perineal template component, thereby enabling a distance between the distal end of the elongate central body and the perineal template to be varied.

[0095] Optionally, the kit further comprising a second component configured to be positioned on the elongate central body adjacent to the first component.

[0096] Optionally, the perineal template component comprises a substantially planar plate, the substantially planar plate comprising the plurality of apertures.

[0097] Optionally, when the perineal template component is positioned on the elongate central body, the perineal template component extends radially out from the elongate central body such that the plate extends substantially perpendicular to a central axis of the elongate central body. Optionally, each of the apertures of the perineal template component is configured to guide a needle parallel to the central axis of the elongate central body. Optionally, when the perineal template component is positioned on the elongate central body, the apertures of the plurality of apertures are arranged around the elongate central body.

[0098] Optionally, the kit further comprises a fixation element configured to be positioned on the elongate central body, the fixation element being configured to secure the plurality of components with respect to the elongate central body.

[0099] Disclosed herein is a modular applicator suitable for delivering brachytherapy treatment, the applicator comprising an elongate central body and a plurality of components affixed to the elongate central body, each comprising a central opening, wherein the elongate central body is positioned through the central opening of each of the plurality of components. The plurality of components comprise a first component configured to be positioned at a distal end of the elongate central body, a perineal template component comprising a plurality of needle apertures each configured to guide a needle therethrough and a plurality of extension components, each extension component being removable from the central elongate body such that a variable number of extension components may be positioned between the first component and the perineal template component, thereby enabling a distance between the distal end of the elongate central body and the perineal template to be varied.

[0100] Optionally, the elongate central body comprises at least one passage to enable passage of a radioactive seed therethrough.

[0101] Optionally, the modular applicator is assembled from the kit.

[0102] Disclosed herein is a method of assembling a modular applicator, the applicator suitable for delivering brachytherapy treatment. The method comprises selecting a first component from a plurality of components, wherein each of the plurality of components comprises a central opening through which an elongate central body can pass, positioning the first component at a distal end of the elongate central body. The method further comprises selecting a perineal template component from a plurality of perineal template components, determining, based on a patient's anatomy and / or the patient's treatment needs, a required distance from the distal end of the central elongate body to the perineal template component, determining, based on the required distance, a required number of extension components which should be positioned between the first component and the perineal template component, positioning the required number of extension components on the elongate central body and positioning the perineal template component on the elongate central body.

[0103] Optionally, wherein positioning the perineal template component on the elongate central body comprises positioning the perineal template component on a selected extension component.

[0104] Optionally, the method further comprises positioning a fixation element on the elongate central body adjacent to the plurality of components. Disclosed herein is a computer-implemented method of generating an optimal applicator configuration, the applicator being suitable for treating a patient via brachytherapy. The method comprises receiving information regarding treatment needs of the patient and outputting, based on the received information, an optimal applicator configuration for the patient's brachytherapy treatment. Wherein the optimal applicator configuration comprises a recommended elongate central body selected from a plurality of central elongate body options, a recommended distal component selected from a plurality of distal components for attaching to the elongate central body and at least one recommended extension component for attaching to the elongate central body selected from a plurality of extension component options.

[0105] Optionally, the received information regarding the treatment needs of the patient comprise any one or more of: information regarding the location, orientation, and shape of one or more tumours; information regarding the location, orientation, and shape of one or more organs at risk (OARs); information regarding the type of cancer and / or the cancer diagnosis; one or more medical images depicting the patient anatomy; medical information associated with the patient; and dose information as prescribed by a clinician or in accordance with an existing treatment plan.

[0106] Optionally, wherein outputting the optimal applicator configuration comprises using a trained machine learning model.

[0107] Optionally, the recommended distal component and the recommended at least one extension component comprise a plurality of needle channels, each needle channel configured to guide an interstitial needle.

[0108] Optionally, the optimal applicator configuration further comprises one or more recommended needle channels of the recommended distal component and the at least one recommended extension component to place an interstitial needle in.

[0109] Optionally, the optimal applicator configuration further comprises a recommended angulation of the one or more needles with respect to a central axis of the recommended elongate central body.

[0110] Optionally, the optimal applicator configuration further comprises a recommended perineal template component, selected from a plurality of perineal template components. Optionally, the method further comprising generating one or more recommended configurations for a 3d-printable component. Optionally, wherein the one or more recommended configurations for a 3D printable component comprises: a shape of a recommended distal component; a size of a recommended distal component; and a shape of a recommended perineal template component.

[0111] Optionally, the method further comprises generating instructions for a 3d printing device, based on the one or more recommended configurations.

[0112] Optionally, the method further comprises based on the received information, generating a brachytherapy treatment plan which uses the optimal applicator configuration.

[0113] Optionally, the treatment plan comprises any of: a location of a radioactive source along a specified channel of the optimal applicator configuration, a recommended dwell time of the radioactive source at the recommended location; a recommended type of radiation source; a recommended number of radiation sources.

[0114] Disclosed herein is a computer readable medium comprising instructions which when executed by a computer, cause the computer to carry out any of the steps according to the present invention.

[0115] Disclosed herein a computer program product comprising instructions which, when the program is executed by a computer, cause the computer to carry out any of the steps according to the present invention.

[0116] Disclosed herein is a kit for a modular applicator, the applicator being suitable for delivering brachytherapy treatment, the kit comprising an elongate central body and a plurality of components each comprising a central opening through which the elongate central body can pass. The plurality of components comprising a first component configured to be positioned at a distal end of the elongate central body, a perineal template component comprising a plurality of apertures each configured to guide a needle therethrough and one or more extension components configured to be positioned on the elongate central body between the first component and the perineal template component, wherein the perineal template component is configured to be moveable about a central axis of the elongate central body. Optionally, wherein the elongate central body comprises at least one passage to enable passage of a radioactive seed therethrough.

[0117] Optionally, the needle is configured to enable passage of a radioactive seed therethrough.

[0118] Optionally, the first component and the one or more extension components comprise at least one needle channel configured to guide a needle therethrough.

[0119] Optionally, the perineal template component comprises one or more ridges located on the central opening of the perineal template component.

[0120] Optionally, the one or more extension components comprise one or more recesses located on the outer surface of the one or more extension components respectively, the one or more recesses configured to receive the one or more ridges of the perineal template component such that the perineal template component is brought into a preferred orientation with respect to the elongate central body.

[0121] Figure 1 depicts an example configuration of an applicator apparatus in accordance with the present disclosure. The apparatus comprises a plurality of components, and the apparatus can be disassembled into its component parts and re-assembled, with the same, similar or different component parts, as will be described later herein according to the needs of the treatment and / or the patient.

[0122] The apparatus comprises a central body. The central body is tube-shaped and may be described herein as a central tube. The central tube comprises a central cavity through which, in use, a radioactive source may be moved. The depicted central tube comprises an intrauterine tube, which extends at an angle from the main body of the central tube. In general, the central tube acts as a central foundation on which a particular applicator configuration can be built.

[0123] The depicted applicator apparatus further comprises a cuff segment, a paravaginal segment, and a vaginal segment. While these components are referred to as segments, they may similarly be referred to as "components", "elements", "pieces" or "portions" herein. Each of these components is configured to be inserted inside a patient during use. The apparatus further comprises a perineal template, which in turn comprises a perineal template base and a perineal template extension. The perineal template base is removably coupled to the perineal template extension. The apparatus further comprises a fixation element configured to fix the perineal template and / or the other components which make up the applicator in place during use. Each of these components comprises an opening through which, in an assembled state as depicted in figure 1, the central tube can pass.

[0124] In use, the applicator central tube is connected, at an opposite end to the intrauterine tube, to a transfer tube (not shown). The transfer tube enables a radioactive source to pass from an afterloader and into the cavity of the central tube. The radioactive source can be advanced along the central body, including into the intrauterine tube, to the extent required by the treatment plan.

[0125] In addition, the applicator apparatus can be configured to hold and help position one or more interstitial needles (not shown). Each of the cuff segment, paravaginal segment, vaginal segment components comprise a plurality of channels 105 to secure and guide interstitial needles. The channels are substantially parallel with the central channel of each component. The perineal template also includes a plurality of channels, otherwise named apertures or holes, to guide interstitial needles. These apertures may be provided in a grid pattern.

[0126] These channels are configured to receive and route interstitial needles in which the radiation source can move to treatment sites. This gives clinicians a range of options, and enables them to provide either intracavity and / or interstitial delivery of radiation according to the treatment needs.

[0127] Figures 2a-e depict an example range of options of modular components which may be used to assemble a configuration of an applicator apparatus in accordance with the present disclosure.

[0128] Figure 2a depicts a plurality of different central body options. The different options comprise different lengths to accommodate different components, and in addition comprise different options when it comes to intrauterine tubes. The topmost central tube depicted in figure 2a does not comprise any intrauterine tube. This design may be suitable, for example, when treating endometrial cancers post-hysterectomy.

[0129] The options depicted in figure 2a comprise options with intrauterine tubes of different lengths. The clinician can thereby select the central body which comprise the intrauterine tube most suitable for treating a patient. The central tube may also comprise a plurality of intrauterine tubes, in a manner which will be disclosed in greater detail below. Such central bodies may be particularly suited for treating certain kinds of cancer, for example endometrial cancer. Figure 2b depicts a plurality of different options for the cuff segment. Again, the clinician or other user can select the cuff segment which is most suited for the treatment needs of the patient at hand. The top row of options shows different diameter options, without interstitial needle guidance channels. Each cuff segment in the top row top row is short and rounded in shape. The second row of options shows the same diameter and general shape options as the first row, but with a plurality of interstitial needle guidance channels both comprised within the body of the component, and also around an outer perimeter which are partially enclosed by the component. The third row of options are substantially frustoconical in shape and do not comprise channels for interstitial needles, whereas the fourth row shows the same diameter options as the third row, but with interstitial needle channels. The fifth and sixth row show options which have a 'double dog ear' shape. The diameter of these cuff segments is not constant, and instead increases and flares outward as the cuff segment extends from a first to a second circular face of the segment. The fifth row options do not comprise channel for interstitial needles, but the sixth row options do. The seventh row of options are shaped and configured much like the second row, but with fewer interstitial needle channels. The eight row of options comprise a first and a second circular face which are at an angle to one another, such that the final face is slanted. Finally, the ninth row of options is similar in shape and function to the first row, but these cuff segments are longer.

[0130] Figure 2c depicts different options for the paravaginal segment. As can be appreciated, just as with the cuff segment options, a variety of diameters can be provided, along with a variety of options for interstitial needle channels. Each row depicts different options for interstitial needle channels, and each column is a different diameter.

[0131] Figure 2d depicts different options for the vaginal segment.

[0132] Figure 2e depicts different options for the perineal template base (first row), each of which have different interstitial channel / aperture patterns and options, and an example of a perineal template extension or extender (second row). As can be appreciated, each perineal template base component comprises an outer perimeter shape that aligns with an inner perimeter shape of the perineal template extension component, allowing the components to fit together easily during assembly. Each component depicted herein may comprise an individual unique tag or marker that enables that component to be uniquely identified in medical images. In an example, the tag or marker may be radio-opaque and / or MR visible.

[0133] To assemble the applicator apparatus, for example into the configuration depicted in figure 1, a clinician or other user first starts with the appropriate central tube. In particular, the central tube that comprises the intrauterine tube depicted in figure 1. The user would then, according to the needs of the treatment and patient at hand, would additionally decide whether a cuff segment, a paravaginal segment, a vaginal segment, a perineal template base and / or an extension are needed. If the user decides that an applicator comprising each of these components is required, then they connect the perineal template base with the perineal template extension by fitting the extender over the base component and aligning the surface geometries of these components to fit them together. Then, the user inserts the central tube into the central aperture in each of the selected cuff segment, paravaginal segment, vaginal segment, and perineal template base component. The user then similarly slides on the fixation element and locks the fixation element in place, thereby affixing the applicator together into a custom configuration optimised and tailored for a particular patient's treatment.

[0134] In use, the user would position the applicator for treatment, and connect one or more transfer tubes to the central channel of the applicator and / or to any interstitial needles positioned in the applicator. An afterloader is used to advance radiation sources / seeds into the central channel and / or interstitial needles in a known way, which need not be discussed in detail herein.

[0135] The modular applicator design disclosed herein is advantageous for several reasons. By tailoring the applicator shape, size, and design for a particular patient, it is possible to achieve an improved anatomical fit, and improve patient comfort. It is also possible to reduce air gaps between the radiation source and the patient tissue, thereby aligning expected and planned dose delivery with realised dose delivery. In addition, there are an extremely large number of options for positioning the radiation source, which in turn means that the treatment plan can be personalised and made more accurate and tailored for the patient's cancer and anatomy. Finally, hospital staff can be confident they have the 'right' applicator to match the patient's cancer, and that additional applicator products are not required. Figures 3a-f depict particular configurations for an applicator assembly in accordance with the present disclosure. The depicted applicators can be assembled by selection of the appropriate options depicted in figures 2a-e. Figures 3a-c depicts applicator assemblies configured to be particularly suitable for treating endometrial cancer in post-hysterectomy. Figure 3a depicts an applicator with no interstitial needle channels, whereas figure 3b depicts an applicator comprising multiple guide channels suitable for IC treatment. Figure 3c depicts an applicator comprising guide channels for IC treatment, in addition to multiple channels for IS treatment.

[0136] Figure 3d depicts an applicator assembly particularly suited for treating primary vaginal & cervical cancers, where the target is positioned in a lower part of the vagina. The applicator comprises a single-channel intrauterine tube, multi-channel components which enable the positioning of IS needles, and a perineal template to enable further IS needle placement.

[0137] Figure 3e depicts an applicator arrangement / configuration suitable for treating inoperable endometrial cancer. The arrangement comprises a multi-channel intrauterine tube, along with multichannel components including the double dog-eared shaped cuff and paravaginal segment to enable both IC and IS needle placement.

[0138] Figure 3f depicts an applicator arrangement / configuration suitable for treating vulval cancer. For this applicator an intrauterine tube is not needed. The applicator comprises a rounded cuff, and cylindrical segments without channels or guides for IC / IS needles. The applicator comprises an IS perineal template, as well as flexible implant tubes.

[0139] Figure 4 depicts different possible needle placements which can be achieved using modular applicator assemblies of the present disclosure. The figures depict both IC and IS needles. IC needles are those which will provide dose from within the cavity, and IS needles are those which will be inserted into patient tissue to provide dosage from the tissue directly surrounding the tumour. The different colours represent different diameter needles. It will be appreciated that a large number of options is made available to the healthcare provider when determining optimal dose profile and needle placement.

[0140] Cuff segments according to the present disclosure may comprise 'parallel' channels which are parallel with the central axis of the applicator, and / or parallel with the central channel of the applicator. These channels enable catheters / needles to extend out from the cuff segment and be positioned substantially along the axis of the applicator, and these are suitable for treating a back wall of a uterus (or a vagina for patients post-hysterectomy). Cuff segments according to the present disclosure may also comprise 'oblique' channels, which extend substantially parallel to the applicator central channel before being configured to divert a needle / flexible catheter out from the cuff segment at an oblique angle.

[0141] Similarly, paravaginal segments according to the present disclosure may comprise 'parallel' channels which are parallel with the central axis of the applicator, and / or parallel with the central channel of the applicator. These channels align with one or more corresponding channels in the cuff segment, and allow a clinician to insert a needle / catheter through the paravaginal segment, through the cuff segment, and potentially out form the end of the cuff segment into the patient's tissue. Paravaginal segments according to the present disclosure may also comprise 'oblique' channels, which extend substantially parallel to the applicator central channel before being configured to divert a needle / flexible catheter out from the paravaginal segment at an oblique angle.

[0142] As can be appreciated from the figure, paravaginal components according to the present disclosure enable the placement of oblique needles which extend from the applicator at an angle. These needles can be IS needles positioned, for example, in the vaginal walls of the patient. The combination of the appropriate cuff segment 404 with the appropriate paravaginal segment 406 gives clinicians a large range of options for needle placement, both for IS and IC treatment. Providing a plurality of options enables clinicians to plan treatment to reduce the effects of either so-called "hot" or "cold" spots.

[0143] The modular components which make up an assembled applicator can be fitted together and held in the correct orientation and alignment in a number of ways. Generally speaking, in one implementation, the components can be assembled and fitted together in any of several ways. In an example, the components (e.g. selections from figures 2b-2e) are fitted onto a central tube (e.g. selections from figure 2a). The user positions and orients the components for their intended purpose, and then locks the components into place using a fixation element. The components stay in their position and orientation by virtue of friction between each component.

[0144] In some implementations, each component, as appropriate, may comprise a small annular lip, extension, or ridge at its proximal end (i.e. the end which, in use, will be closest to the clinician as they insert and position an applicator). This annular extension has a smaller radius than the component generally. Each component may also comprise, as appropriate, a corresponding annular recess which is sized, shaped, positioned, and otherwise configured to accept an annular ridge of another component. By virtue of providing each component with an annular extension on its proximal side and a corresponding annular recess on its distal side, a user is guided to position the components along the central tube, and the friction between each component is increased significantly. This ensures that the components cannot move from the user-selected position and orientation.

[0145] Figures 5a-5e depict one or more mechanisms by which components, for example cuff segments and paravaginal segments, of the present disclosure may be positioned, and / or fixed in place, with respect to a central tube 510. Figures 5a and 5b depict an end section of a central tube 510. The central tube 510 comprises a central channel 513 to accommodate a radioactive source, and / or needles and catheters. The central tube 510 also comprises a recess 511 along its length. The recess 511 is positioned on an underside of the central tube 510 (with respect to its orientation in use). The recess 511 is shaped, positioned and otherwise configured to receive a corresponding ridge positioned on other components which may be fitted onto the central tube.

[0146] In an example, paravaginal segments according to the present disclosure, for example the segment 530 depicted in figure 5e, may comprise elongated ridges / protrusions 531 placed on their inner annular surface. This inner annular surface, when the segment is positioned on a central tube, will contact an outer surface of a central tube. The ridge is elongated in the direction of a central axis of the central tube. The ridges are positioned, shaped, and otherwise configured to interact with the elongated recess 511 of a central tube such that, in use, the user is guided to position the paravaginal segment 530 on the central tube 510 in the correct orientation. By providing similar and corresponding ridges and protrusions on each component, the user is guided to position each component on the central tube in a manner which is appropriate for the assembled applicator and in a manner which will ensure the various channels of the components (for example the paravaginal segment and cuff segment) will align with one another.

[0147] Cuff segments, such as the cuff segment 520 depicted in figure 5c, comprise an elongated ridge 521, much like other components, that fits into the elongated recess 511 of the central tube 510. However, this ridge 521 does not extend along an entire length of the cuff segment 520. The cuff segment also comprises a recess 522. The recess 522 is shaped, positioned, and configured to interact with the end stopper 512 of the central tube. The ridge 521 and recess 522 are positioned along a length of the cuff segment, on an inward facing annular surface of the cuff segment 520. To assemble an applicator, a user slides the cuff segment 520 onto the central tube 510, making sure that the ridge 521 is aligned and fits within the guiding recess 511. As the cuff segment 520 nears the end portion of the central tube 510, the ridge 521 meets the end stopper 512. This defines the maximum degree to which the cuff segment 520 can be slid along the central tube 510.

[0148] Figure 5d depicts a cross-section of the cuff segment 520 located at an end point of the central tube 510. The ridge 521 is in contact with the end stopper 512, preventing movement of the cuff segment 520. In use, another component such as a paravaginal segment will be positioned behind and alongside the cuff segment 510 on the central tube 510, and thereby the cuff segment 510 can be locked in place in its correct orientation at the end of the central tube 510.

[0149] While the mechanism has been described with recesses on the central tube and ridges on the components, the skilled person will appreciate that these features can be 'swapped' and interchanged, for example so that the components comprise grooves or recesses, and the central tube comprises an elongated ridge.

[0150] Figures 5f-i depict a fixation element 570, and the manner in which it may fix components in place with respect to the central tube 510. As shown in figure 5g, the central tube 510 may comprise a series of notches 580 located at fixed intervals along a length of the central tube 510. These notches 580 are shaped, positioned and otherwise configured to receive a corresponding a fixation member such as a notch 575 on an inner surface of the annular fixation element 570. The notch 575 takes the form of a ramp or wedge with a flat back face. The wedges 580 mirror this shape. The fixation element 570 is broadly annular and substantially U-shaped. In other words, element 570 has a cutout such that it can be described as comprising an incomplete ring. The shape can be thought of as comprising two curved arms which curve toward each other, but which do not come into contact while the fixation element is in a rest position. The shape of the fixation element 570, and the resilience of the material it is comprised of, means that its diameter can be adjusted by user pressure, and / or the curved arms can be forced apart. The wedge 575 is positioned on one of these curved arms of the U-shaped fixation element 570.

[0151] In an example, a user places their chosen components on the central tube 510. The components have the correct orientation, as guided by the ridge and groove / recess mechanisms described above. When the user has positioned the desired components on the central tube 510, the user positions the fixation element 570 on the central tube 510. Due to the wedge shape of the protrusion 575 and the recesses 580, the user can easily slide the fixation element 570 along the central tube in a direction toward the distal end of the applicator. When the fixation element 570 is positioned behind the other components, the user can rotate and position the fixation element 570 such that the wedge 575 is positioned in a recess 580. This prevents the fixation element 570 from moving backwards, i.e. in a direction of a proximal end of the applicator, and thereby locks the components in place on the central tube 510. When a user wishes to release the fixation element 570, they simply need to twist, i.e. rotate the fixation element 570. The twisting action forces the curved arms of the element 570 apart slightly, and the wedge 575 can be easily removed from the recess 580.

[0152] Figure 6 depicts a plurality of options for a central tube, in addition to those depicted in figure 2a. These central tubes are particularly suited for forming an applicator optimised for treating endometrial cancer.

[0153] All the central tubes depicted in figure 6 are comprised of MR-safe materials. They applicator components may be comprised of one of more thermoplastics which will enable flexibility, but are also glass-fibre reinforced to prevent breakage.

[0154] The first central tube, 600, comprises a multi-channel main body 606, and a multi-channel intrauterine section 604. The central tube 600 comprises a plurality of channels which extend through a main body 606. Each of the channels 601, 602, 603 is configured to receive a radioactive source or 'seed', which can be passed along the main body of the central tube toward the intrauterine section in use. The plurality of channels comprise a first channel 601, a second channel 602, and a third channel 603 which are each biased out and away from a central axis of the first central tube 600.

[0155] The first central tube 600 further comprises a slideable sheath 605. The slideable sheath 605 is configured to slide along and over the main body 606 of the first central tube 600. Both the slideable sheath 605 and main body 606 are annular in cross-section. The slideable sheath 605 is configured to slide along an axis parallel with, or coincident with, a central axis of the main body. The first central tube 600 comprises a disc-shaped 'stop' 607 which defines the extent to which the slideable sheath 605 can be retracted back and away from the intrauterine portion 604. The slideable sheath 605 is configured to slide over the main body 606 of the central tube 600 toward the intrauterine portion 604. As the slideable sheath reaches the first intrauterine channel 601 and the second intrauterine channel 602, it passes over them and pushes them together. As the slideable sheath 605 continues to move along the main body 606, each of the channels 601, 602 and 603 are brought together to fit under the slideable sheath 605. As the slideable sheath 605 is retracted, i.e. moved in the opposite direction away from the intrauterine portion 604, the channels

[0156] 601, 602 and 603 again open out and splay apart to form the configuration depicted in figure 6.

[0157] In use, a clinician may insert an applicator apparatus comprising the first central tube 600 while the slideable sheath 605 is in an extended position; i.e. while the intrauterine channels 601-603 are held together via the slideable sheath 605. After the intrauterine portion has been inserted into the patient, the clinician can retract the slideable sheath 605, causing the intrauterine channels 601,

[0158] 602, 603 to extend and splay apart. By this action, the channels 601-603 extend toward patient tissue and can be positioned according to the requirements of the treatment plan. When the clinician comes to withdraw the applicator, they can once again move the slideable sheath 605 into the extended position, thereby bringing the channels 601-603 together again to facilitate withdrawal.

[0159] In this way, the first central tube 600 provides a multi-channel intra-uterine portion, thereby providing clinicians with multiple options for source placement, while also enabling simple placement and withdrawal of the applicator in a way that maximises patient comfort. While the depicted implementation comprises three channels in the intrauterine portion 604, it should be understood that any number of biased / outwardly splaying channels can be used.

[0160] The second central tube 610 comprises an intrauterine portion 614 and a main body 616. These components both comprise multiple channels in the manner described above. The intrauterine portion 614 comprises a plurality of flexible tubes. In the depicted implementation, these flexible tubes are flexible catheters. These flexible catheters have some degree of rigidity and extend from the main body 616 in a rest state, but are also configured to bend and deform slightly as they encounter resistance. The flexible catheters extend through the main body 616 such that, in use, a radioactive source can be passed through any of the catheters. This configuration is advantageous as the flexible catheters may be simply removed from the main body 616 to enable sterilisation, and then re-inserted. The third central tube 620 also comprises an intrauterine portion 624 and a main body 626. The intrauterine portion 624 comprises a plurality of hollow tubes which are flexible but semi-rigid. The hollow tubes splay apart as they extend from the main body 626. Each hollow tube is of a sufficient diameter to allow a flexible catheter 629 to pass along it. Each hollow tube is open-ended. As can be appreciated from the figure, the central body 626 comprises a plurality of channels, each of which becomes a hollow tube at the intrauterine portion. In use, a flexible catheter 629 can be passed along a channel in the main body 626, toward the intrauterine portion 624. The flexible catheter passes into one of the hollow tubes of the intrauterine portion 624. Because the hollow tubes are each open-ended, the catheter can continue to be passed through the central tube 620 and out the distal end of the hollow tube(s) in the intrauterine section. This functionality is useful for clinicians since it effectively enables a degree of extension of the intrauterine channels, and this 'extension' can be performed while the applicator is positioned inside the patient. By virtue of pushing the catheters further down the channels of the central tube 630, the clinician can plan for the radioactive source to be positioned as close as possible to a tumour, and the adjustable length of the intrauterine tube enables a clinician to further reduce the air gap between the radioactive source and the tumour.

[0161] The fourth central tube 630 is similar in form to the second central tube 620, though the intrauterine tubes are not open-ended and thus the length of the intrauterine tubes cannot be adjusted. The tubes are reasonably rigid, providing certainty to clinicians that the tubes won't bend or otherwise change position during treatment.

[0162] The fifth central tube 640 comprises a spiral-shaped intrauterine portion 644. The spiral shaped intrauterine comprises at least one helical channel. The portion 644 may be single or multi-channel. The spiral-shaped intrauterine portion 644 is particularly optimised for positioning radiation seeds close to the internal walls of the uterus, and provides clinicians with a large number of options when it comes to dwell position for the radiation seed.

[0163] The radius of the spiral swept out by the helical channel increases as it extends away from the central body 646, so as to match the internal shape of the uterus. The spiral-shaped intrauterine portion 644 is comprised of resiliently collapsible material which can be compressed on insertion of the applicator, and which springs outward after insertion. This means that the applicator head (the intrauterine portion) expands to fill the available space after insertion, and the helical channel is thereby positioned very close and / or in contact with the patient tissue around its entire circumference.

[0164] The central body 640 may also comprise a retractable sleeve (not shown). The retractable sleeve, or sheath, covers and compresses the spiral-shaped intrauterine portion in a 'closed' or 'extended' configuration, and does not cover and compress the intrauterine portion in an 'open' or 'retracted' configuration. This removal sheath facilitates insertion and withdrawal of an applicator comprising the central tube 640 in much the same way as the slideable sheath 605 does for the first central tube 600.

[0165] Each loop of the spiral shape may comprise a unique CT-visible, i.e. radio-opaque, marker. These markers enable each loop to be distinguished in medical images, and thus treatment planning and treatment delivery is facilitated.

[0166] The sixth central tube 650 also comprises a main body 656 and an intrauterine portion 654. The sixth central tube 650 comprises a plurality of flexible channels, which may take the form of flexible catheters, or otherwise be made of flexible, resilient material. The intrauterine portion, 654, comprises a balloon comprised of resilient material. The main body 656 comprises an inflation channel that passes along the main body 656 and is positioned and configured to pass fluid into the balloon. The fluid can be liquid or gas. The balloon is resilient such that, upon pressurised fluid entering the balloon, it expands.

[0167] The plurality of flexible channels are configured for receiving a radioactive source as with the channels described above in connection with the other tubes 600-640. The main body 656 comprises a rigid material which retains its shape. The flexible channels pass along the main body 656 and are then attached to either an inner, or an outer, surface of the balloon. The flexible channels have sufficient rigidity that, in a rest position, they extend away from the main body 656 in the manner depicted in figure 6, but are flexible such that expansion of the balloon causes expansion of the flexible channels.

[0168] In use, a clinician would insert an applicator comprising the sixth central tube 650 into the patient, and would inflate the balloon using the inflation channel and a suitable source of fluid. The balloon, along with the flexible channels, expands inside the patient, bringing the flexible channels close to the interior wall of the patient's uterus. The applicator can be rotated and positioned, and the degree of inflation of the balloon can be adjusted, giving the clinician a range of options for positioning the flexible channels with respect to the patient's anatomy. In particular, such an applicator is particularly beneficial for positioning the channels close to an interior wall of the uterus, while allowing easy and comfortable insertion and withdrawal of the applicator.

[0169] While particular implementations have been described and are shown in the figures, it should be understood that features of each

[0170] Figure 7 depicts an assembled applicator 700 according to the present disclosure. The assembled applicator 700 is comprised of several different components / modules in the manner generally described herein. The assembled applicator 700 is particularly suited for treating inoperable endometrial cancer. The applicator 700 comprises a central tube of the same type and function as the 'first' central tube 600 described above in relation to figure 6. The central tube comprises a multi-channel main body 718, leading to a multi-channel intrauterine portion 702. The depicted applicator 700 has been fitted with a cuff segment 704, with a shape to optimise contact with internal tissue; a paravaginal segment 706 to enable the placement of oblique (angled) needles via the vaginal wall, a vaginal segment 708, and a perineal template base 710 complete with an extension 712. The fixation element (which is not fully visible in the figure) affixes and locks all the components together in the depicted arrangement such that they move with the slideable sheath 716.

[0171] The applicator 700 is depicted with the slideable sheath in its retracted configuration. As described above, when the applicator is to be inserted into a patient, the slideable sheath 716 is moved forward, such that the arms (i.e. resilient flexible channels) are enclosed within the sheath 716. After insertion, the clinician can retract the sheath while pushing forward with the stopping element 720, thereby keeping the perineal template in position against the patient's perineum while the intrauterine section 702 is moved forward into the patient's uterus. As described above, the arms of the intrauterine portion expand as the sheath is retracted in this way. When the time has come to withdraw the applicator 700, then the clinical holds the applicator in place while pulling the stopper 720 backward. Thereby, a simple and comfortable insertion and withdrawal of the applicator is facilitated.

[0172] Figures 8a-d depict a selection of the central bodies depicted in figure 6 from different angles and / or in different configurations. Figures 8a and 8b depict the first central tube 600. Figure 8a depicts the first central applicator tube in a 'closed' configuration in which the slidable sheath 605 is pushed forward to enclose the arms of the intrauterine portion. Figure 8b depicts the same central tube 600 with the main body 606 pushed forward, within the slidable sheath 605. The slidable sheath 605 and main body 606 are slidably coupled to one another. The action of pushing the main body 606 forward within the slidable sheath, and relative to the slidable sheath, causes the plurality of flexible arms to splay outward bi virtue of their natural biasing away from a central axis of the central tube 600.

[0173] Figures 9a-g depict different possible source channel and needle placement options, when appropriate selections are made from the different available cuff segment options depicted in figure 2b, and different available paravaginal segment options depicted in figure 2c. the arrangements get more complex as they progress form a to g. Figure 9a depicts an applicator in which a central channel for the radioactive source is provided. Depending on the choice of central tube (e.g. from figures 2a and 6), the applicator assembly may, or may not, comprise an intrauterine tube which extends from the cuff segment. Figure 9b depicts a multi-channel central tube. Each channel is parallel with each other and with the central axis of the central tube. There may be a central, large diameter channel, surrounded by smaller diameter channels. Each of which allow the placement of a radioactive source. Figure 9c depicts a similar cuff and paravaginal segment to that depicted in figure 9b, but with the addition of a tendon, or catheter, in the central channel which can extend into the patient. Such an approach is suitable for patients who have undergone partial hysterectomies.

[0174] Figure 9d depicts an arrangement in which needles are passed through the channels surrounding the central channels. Figure 9e depicts an arrangement with oblique, i.e. angled needle placement, in addition to a straight needle placement. Figure 9f depicts an arrangement comprising additional oblique needles, suitable for insertion through the vaginal wall. These additional needles may increase insertion accuracy. Finally, figure 9g depicts an applicator with needles positioned via a perineal template.

[0175] Figures lOa-lOe depict cuff segment shapes according to the present disclosure. One issue that can face clinicians in the brachytherapy space as they try to reach an optimal placement and position of the applicator is that the vagina, and other internal tissue associated with the female reproductive system, is not always round, and does not always display rotational symmetry. In an example, if a patent has had their uterus removed, clinicians typically place stitches in order to create a new back wall in the patient's vagina. In this case, the vagina can collapse slightly, or can be opened up slightly to form an atypical shape. Despite this, prior art applicator heads are typically broadly cylindrical in shape, with a regular circular cross-section. This type of known applicator cross-sectional shape is depicted in figure 10a, and this shape is depicted in dashed lines in each of figures lOb-lOe to assist the skilled person in comparing the novel shapes depicted in figures lOb-e with this generally known shape. Speaking generally for each of the cuff segments depicted in figures lOb-e, the goal is to reach a better anatomical fit that matches the internal walls of a patient's vagina, particularly after the vagina has been stitched to create a new back vaginal wall post-hysterectomy. Providing different cuff segment options enables clinicians to make choices which ultimately lead to a better anatomical fit, and thereby to improved dose delivery.

[0176] In addition to depicting cross-sectional shapes of cuff segments, figures 10b, 10c, and lOd additionally depict needle patterns that are possible by using the relevant cuff segment. Each cuff segment has a plurality of needle / catheter channels which enable to the needle placements depicted in the figures.

[0177] For cases where the patient's vagina has collapsed slightly, or otherwise where the patient has an atypically shaped vagina, an applicator shaped in accordance with the shape presented in figure 10b may be an optimal shape for brachytherapy treatment. It is possible to imagine a vagina that has the same cross-sectional shape as the cuff segment depicted in figure 10b; in this case, a cuff segment which is shaped in accordance with the shape depicted in figure 10a is non-optimal, since it cannot reach the back wall of the vagina while still providing a good anatomical fit with the surrounding vaginal walls. This is a problem as, often, it is the back wall of the vagina which the clinician wants to irradiate via brachytherapy treatment. Using a sub-optimally shaped applicator as depicted in figure 10a would lead to air gaps between the radiation source and the tumour, since it is not possible to bring the applicator head close enough to the tumour. By instead using a cuff segment (and accordingly applicator head) shaped as depicted in figure 10b, a better anatomical fit can be achieved, leading to improved dose delivery. In addition, with a better anatomical fit, it can be easier for a clinician to insert needles via the applicator.

[0178] The cuff segments depicted in figure 2b, in particular the 3rdand 4throw, may comprise the cross- sectional shape depicted in figure 10b. The cuff segment comprises a first substantially circular face which, in use, is likely positioned against a paravaginal segment or vaginal segment. This first circular face interfaces with the other components of the applicator and is proximal to a clinician when inserting and positioning the applicator. The second substantially circular face is positioned at an opposite end of the cuff segment and, in use, this second face would be positioned against, or close to, a back wall of the patient's vagina or uterus. This second face is distal to the clinician when inserting and positioning the applicator. The second substantially circular face has a smaller diameter than the first substantially circular face, and the cuff segment smoothly transitions between these two diameters to form a rounded cone shape. Optionally, the cone may be 'offset', in that the centre of the second circular face may not align with the centre of the first circular face along a central axis of the applicator main body. Such an offset, smoothed, frustoconical shape is depicted in figure 10b, and can be appreciated by inspection of the sagittal view of the cuff segment.

[0179] Figure 10c depicts a cuff segment comprising what can informally be called "double dog ear" shape. Cuff segments comprising this kind of cross-sectional shape are depicted in the 5thand 6throw of figure 2b. Again, cuff segments taking this cross sectional shape may be particularly suited for particular patient's anatomies. In an example, post-hysterectomy, after stitching has taken place then a patient's back vaginal wall may take the cross-sectional shape depicted by the applicator / cuff segment of figure 10c. While reference is made to patients that have undergone a hysterectomy, cuff segments with this kind of cross-sectional shape may also be suited to a patient's anatomy who have not undergone this procedure.

[0180] In cross-section through a coronal plane, the cuff segment depicted in figure 10c flares radially outward at its distal face. Approaching the distal face, the diameter of the cuff segment increases to create a bulge on either side of the cuff segment. After reaching a point of maximal diameter, the diameter reduces again toward the distal face. A U-shaped recess is formed in the very end of the cuff-segment. In cross-section through a sagittal plane, the cuff segment comprises a smoothed, broadly cylindrical shape. The result is two curved extensions which take the rough shape of "dog ears", and which extend out from opposing sides of the cuff segment and at a far, distal end of the cuff segment.

[0181] Figure lOd depicts a similar shape to that depicted in figure 10c, but with only a single "dog ear" shape displayed. Figure lOe depicts a cuff link with an alternative shape.

[0182] Figure 11 depicts an assembled brachytherapy applicator 1100, in accordance with the present disclosure. The assembled applicator 1100 comprises a cuff segment 1101 that takes the general form and shape as that shown in figure 10c. As described above, the cuff segment comprises channels which enable needles to be positioned at a variety of angles and positions, for example radially inner channels 1120a which are primarily parallel to a central axis of the applicator body which enable needles to be placed at an angle substantially parallel to the central axis, and also radially outer, angled channels 1120b which angle out and away from the central axis and which enable the placement of oblique, angled needles, for example into patient tissue.

[0183] The assembled applicator 1100 further comprises an extending segment 1190. Extending segments 1190 can be used in any applicator arrangement of the present disclosure. The purpose of the extending segment 1190 is to extend the length of the applicator 1100 according to the treatment requirements, for example to ensure the cuff segment 1101 can be placed proximal to a back wall of the patient's uterus or vagina. The extending segment 1190 can be positioned between any components described herein to provide extra length or extension to the applicator, and thereby to provide the clinician and treatment planning team with additional options for source and needle placement.

[0184] The assembled applicator 1100 comprises a perineal template base 1110 and two template extenders 1112a, b, positioned either side of the template base 1110. As can be appreciated from the figure, the template base 1110 and the base extenders 1112a, b, have complementary outer perimeter shapes, such that the extenders 1112a, b, can fit against the base template 1110. The template base 1110 also comprises a protrusion or ridge, 1111, which extends from a main body of the template base 1110 and is shaped, positioned and otherwise configured to fit into a corresponding recess in the template extenders 1112a, b. This ensures proper placement and fitting of the extenders 1112a, b. The template base 1110 further comprises one or more extensions 1113 which are configured to extend from a main body of the base template 1110 and provide a backing for an extender to be placed against. The protrusion9s) 111 may be positioned at least partially on the extensions 1113. The extensions 1113 provide support for the template. The base plate 1110 and extenders 1112a, b, may also comprise additional attachment means (not shown) to enable the extenders 1112a, b, to be fixed in place, for example channels to enable a screw fitting to lock an extender 112 against an extension 1113.

[0185] Figures 12a, 12b depict a needle locking mechanism in accordance with the present disclosure. When using needles, a clinician wants to place needles right below the surface of the applicator (before inserting the applicator in the patient). Once the applicator is inserted, the clinician wants to insert the needle to a certain (pre-defined) depth. For this, they need a reference length, which is the length of the front of the Guiding Tube to the applicator surface, the length of the Guiding Tube and the length of the needle. By providing the depicted needle locking mechanism in the cuff segment for each channel, the reference lengths can be kept the same for all the different channels, clinicians can insert the needles to the preferred depth independent to which channel they want to use or independent to the design / curve of the channel. It should be understood that the features described above and generally herein in relation to specific component or central tube implementations can be combined together, and that features of a particular component may be used with features of a different component.

[0186] Applicator configuration selection, and accompanying software

[0187] The presently disclosed modular applicator provides clinicians with a range of options for treating different types of cancer, different patient anatomies, and generally providing optimised and personalised brachytherapy treatment.

[0188] The present application also relates to methods of selecting a particular applicator configuration which is optimised for particular treatment needs. This method may be fully or semi-automated, and may be based on information provided by a clinician, or retrieved from a database, about the treatment needs.

[0189] Figure 13 depicts five examples of different treatment needs, and appropriate modular applicator configurations which can be assembled rom available components in the manner disclosed herein in order to optimally treat the patient. The skilled person will appreciate that the figure exists to provide an example of software functionality, and the recommended applicator configurations depicted in the figure may, or may not, in reality be optimised for the particular treatment needs depicted.

[0190] In a first example, a user intends to treat a post hysterectomy patient that has endometrial tumours. A schematic depiction of a medical image showing the patient's anatomy and tumour position(s) is shown in the figure in the first row. The user inputs information into a user interface about the treatment needs, for example information regarding the type of cancer, the tumour shape, location and orientation, the location, orientation and shape of any organs at risk (OARs), as well as any already prescribed dosages including minimum dose to be delivered to the tumour and maximum doses that can safely be delivered to any OARs. Providing this information may comprise providing one or more medical images depicting the patient anatomy. The images may be segmented to depict particular tissues, or the software can run auto-segmentation software in order to extract information about the patient anatomy. In the first example, the user uploads one or more medical images of the patient anatomy, and provides information that the patient is post-hysterectomy and that the cancer is endometrial in nature. This information is processed, and the user receives an output that the appropriate configuration of medical applicator comprises an intravaginal tube, with no intrauterine tube. The software is also able to recommend appropriate options for a cuff segment (e.g. IC single channel), a paravaginal segment (IC and IS multi-channel). The appropriate applicator configuration is depicted in the far right column of the first row.

[0191] The present disclosure therefore relates to a computer implemented method, and system, for recommending an appropriate configuration for a modular applicator. In a second example, based on the inputted treatment and / or patient information, the software recommends two appropriate options for applicator configuration, which enables user-choice.

[0192] The third row of figure 13 depicts three types of cancer which may all be treated by the same applicator configuration (see far right column). In an example, a processor receives information about the patient anatomy. This may take the form of one or more medical images, for example of one of the cancer types shown in figure 13, for example primary vaginal cancer. The one or more images may be CT, MRI, or other imaging modalities, and may be a plurality of 2D slices depicting the 3D treatment volume and / or may be a 3D image.

[0193] The processor segments the images using known auto-segmentation techniques (alternatively, the image(s) may be already segmented by the user). The processor derives, from the one or more images, information regarding the location of tumours in the patient anatomy.

[0194] Based on the location of tumour(s) in the patient anatomy, the processor outputs an appropriate applicator configuration. In the depicted example in the third row, the processor determines that an applicator comprising a central tube comprising a single-channel intrauterine tube is optimal, and that the applicator should be further assembled to comprise IS multi-channel cylinder segments (e.g. paravaginal segments), along with a perineal template base (with no extension) to enable IS needle placement. The processor is further configured to output suggested needle positions and placements, and which channels of the components will be optimal to use when placing these needles. While the overall applicator configuration is the same for each of the depicted three cancer types, these needle suggestions will be different for each type of cancer and depending on the tumour location and patient anatomy.

[0195] In a fourth example, in which a patient has been diagnosed with inoperable endometrial cancer, the user does not provide medical images but instead manually inputs information regarding the type of cancer (e.g. inoperable endometrial) and about the tumour location (e.g. large, multi-site, back wall of uterus). Based on this information, a processor processes the information and outputs an optimal applicator configuration as depicted in the fourth row of figure 13.

[0196] In a fifth example, a processor retrieves one or medical images of a patient. The medical images show patient anatomy, where the patient has vulval cancer with tumours positioned at the vulva. The processor also accesses medical records associated with the patient, which indicate that the patient has been diagnosed with vulval cancer. Based on this information, and the medical images, the processor outputs an optimal applicator configuration as depicted in the figure, in which a perineal template base and extension should be used. A recommended position for each of a plurality of needles and flexible implant tubes is also recommended to the user. In addition, based on the retrieved information, a full treatment plan is generated using the recommended applicator configuration.

[0197] Figure 14 depicts a high-level computer implemented method 1400. At 1410, the processor receives information regarding the treatment needs, or treatment requirements. This information may comprise any of: information regarding the location, orientation, and shape of one or more tumours; information regarding the location, orientation, and shape of one or more OARs; information regarding the type of cancer and / or the cancer diagnosis; one or more medical images depicting the patient anatomy; medical information associated with the patient; dose information as prescribed by a clinician or in accordance with any existing treatment plan.

[0198] At 1420, the received information is processed. The processing stage may comprise consulting one or more look-up tables, flowcharts and / or decision trees. For example, if a patient has vulval cancer, it is typical to make use of a perineal template and this information can be stored in a look-up table, such that if the information receives at block 1410 indicates that the patient has vulval cancer then the software will recommend the use of a perineal template. Alternatively, or additionally, the processing stage at block 1420 may comprise entering the received information into one or more Al or ML-based models. For example, one or more medical images can first be input into a trained ML model such as a neural network or convolutional neural network. This ML model may segment the medical image(s) and identify the location and shape of tumours present in the patient anatomy. The same model, or a different model, may similarly take this information, and / or the segmented images directly, and process them to output a recommended applicator configuration. In an example, an ML model can be trained using a dataset comprising a plurality of medical images depicting different cancer types and tumour positions in the female reproductive system, such as vaginal and endometrial cancers. Each image has been reviewed by a clinician, who has recommended a particular applicator type for the tumour(s) depicted in the image. This forms the basis of a labelled data set suitable for training an ML model, such as a NN or CNN, to process new images and output recommended applicator configurations.

[0199] Alternatively, a simulation technique such as a Monte Carlo simulation technique may be used. For example, every possible applicator configuration, and / or a subset of possible applicator configurations produced according to the type of cancer to be treated, may form part of a simulation on the patient's anatomy to depict which needle and source positions provide the most accurate dose to the patient's tumour(s) according to the dose prescribed by the clinician.

[0200] At block 1430, an optimal applicator configuration is outputted, or generated, based on the processing. This can comprise outputting the recommended applicator components to the user for example via a GUI or other display device.

[0201] In an implementation, the recommended optimal applicator configuration may comprise one or more bespoke, 3d-printable component recommendations. In an example, based on one or more medical images of a patient, it is determined that a non-standard needle placement will enable optimal treatment to be delivered. In this case, the processor may determine a needle / source placement which would provide an optimal dose distribution, and then, by virtue of determining the number of needles and / or flexible catheters that are required, and / or the angle at which these needles and catheters must be placed, can extrapolate these angles back to (for example) a perineal template base component which comprises channels which enable the optimal needle and / or catheter positioning. In other words, a bespoke, personalised component can be designed which will enable optimal needle and / or catheter placement for the patient's particular treatment needs. In turn, instructions for a 3d printing device are generated in a known way, and are passed to the user to enable them to produce the device. This kind of analysis can be performed for any of the components described herein, and needn't only be based on needle angle and placement but also the patient's anatomy, for example the size and shape of the patient's vagina and uterus.

[0202] In an example, a 3d-printed perineal template can take practically any shape, to align with the patient's anatomy. Similarly, a cuff segment of any size and shape can be generated, thereby enabling a more accurate anatomical fit to be established during treatment.

[0203] At block 1440, optionally, a treatment plan is generated and output based on the received information, and which uses the optimal applicator configuration. The treatment plan may specify particular needle, catheter and channel usages, along with usual brachytherapy treatment plan information such as type and number of radiation source, the location of the radiation source (i.e. how far they should be extended along each channel), dwell times at each location, etc.

[0204] 3D printable components

[0205] As described above, methods of the present disclosure may comprise generating data which can be relayed to an additive manufacturing device to enable the additive manufacturing device to fabricate a bespoke component for fitting to a central tube, ultimately for the purpose of providing hyper-tailored treatment to a patient via brachytherapy.

[0206] The 3D printing process and system itself may be standard. As is known to the skilled person, the 3D printing process typically begins with the use of CAD software. This software allows the user to create a digital model of the object to be printed. The CAD software facilitates the precise manipulation of the object's dimensions, geometry, and overall design, ensuring accurate representation during the fabrication process. According to the present disclosure, this model can be automatically generated based on the treatment needs in question.

[0207] The generated digital model of the component may be saved in a standardized file format, such as STL (Stereolithography) or OBJ (Object). These file formats capture the geometrical data of the component and serve as input for the subsequent stages of the 3D printing process.

[0208] The digital file may be processed using slicing software, which converts the 3D model into a series of two-dimensional cross-sectional layers or slices. Each slice represents a specific layer of the component and includes instructions for the printer on how to deposit material for that particular layer.

[0209] The printer hardware may comprise several components, including: a. Build Platform: The build platform provides a stable surface upon which the component may be printed layer by layer. b. Extruder / Nozzle: The extruder or nozzle is responsible for depositing the printing material, such as thermoplastics or resins, layer by layer based on the instructions provided by the slicing software. c. Control System: The printer is controlled by a central control system, which interprets the instructions from the slicing software and coordinates the movements of various components during the printing process. d. Heating System: Many 3D printers incorporate a heating system to maintain optimal temperature conditions for the printing material, ensuring proper adhesion and solidification.

[0210] The printing material used in 3D printing can vary depending on the desired properties of the object being printed. Common materials include thermoplastics, photopolymers, metals, ceramics, and composites.

[0211] Example system

[0212] Figure 15 illustrates a block diagram of one implementation of a system 1500 which may be used to implement methods according to the present disclosure, in particular the methods discussed above with respect to figures 13 and 14. The system 1500 comprises a computing system 1510 within which a set of instructions, for causing the computing system 1510 to perform any one or more of the methods discussed herein, may be executed.

[0213] The computing system 1510 shall be taken to include any number or collection of machines, e.g. computing device(s), that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methods discussed herein. That is, hardware and / or software may be provided in a single computing device, or distributed across a plurality of computing devices in the computing system. In some implementations, one or more elements of the computing system may be connected (e.g., networked) to other machines, for example in a Local Area Network (LAN), an intranet, an extranet, or the Internet. One or more elements of the computing system may operate in the capacity of a server or a client machine in a client-server network environment, or as a peer machine in a peer-to-peer (or distributed) network environment. One or more elements of the computing system may be a personal computer (PC), a tablet computer, a set-top box (STB), a Personal Digital Assistant (PDA), a cellular telephone, a web appliance, a server, a network router, switch or bridge, or any machine capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken by that machine.

[0214] The computing system 1510 includes controller circuitry 1511 and a memory 1513 (e.g., read-only memory (ROM), flash memory, dynamic random access memory (DRAM) such as synchronous DRAM (SDRAM) or Rambus DRAM (RDRAM), etc.). The memory 1513 may comprise a static memory (e.g., flash memory, static random access memory (SRAM), etc.), and / or a secondary memory (e.g., a data storage device), which communicate with each other via a bus (not shown).

[0215] Controller circuitry 1511 represents one or more general-purpose processors such as a microprocessor, central processing unit, accelerated processing units, or the like. More particularly, the controller circuitry 1511 may comprise a complex instruction set computing (CISC) microprocessor, reduced instruction set computing (RISC) microprocessor, very long instruction word (VLIW) microprocessor, processor implementing other instruction sets, or processors implementing a combination of instruction sets. Controller circuitry 1511 may also include one or more special-purpose processing devices such as an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), a digital signal processor (DSP), network processor, or the like. One or more processors of the controller circuitry may have a multicore design. Controller circuitry 1511 is configured to execute the processing logic for performing the operations and steps discussed herein.

[0216] The computing system 1510 may further include a network interface circuitry 1518. The computing system 1510 may be communicatively coupled to an input device 1520 and / or an output device 1530, via input / output circuitry 1517. In some implementations, the input device 1520 and / or the output device 1530 may be elements of the computing system 1510. The input device 1520 may include an alphanumeric input device (e.g., a keyboard or touchscreen), a cursor control device (e.g., a mouse or touchscreen), an audio device such as a microphone, and / or a haptic input device. The output device 1530 may include an audio device such as a speaker, a video display unit (e.g., a liquid crystal display (LCD) or a cathode ray tube (CRT)), and / or a haptic output device. In some implementations, the input device 1520 and the output device 1530 may be provided as a single device, or as separate devices.

[0217] In some implementations, computing system 1510 includes training circuitry 1518. The training circuitry 1518 is configured to train a method of producing, or generating, an optimal applicator configuration, for example. For example, training circuitry 1518 may train a model for performing a method of optimal applicator configuration generation. The model may comprise a deep neural network (DNN), such as a convolutional neural network (CNN) and / or recurrent neural network (RNN). Training circuitry 1518 may be configured to execute instructions to train a model that can be used to generate the optimal applicator assembly. Training circuitry 1518 may be configured to access training data and / or testing data from memory 1513 or from a remote data source, for example via network interface circuitry 1515. In some examples, training data and / or testing data may be obtained from an external component, such as image acquisition device 1540 and / or treatment device 1550.

[0218] In some implementations, the computing system 1510 may comprise image processing circuitry 1519. Image processing circuitry 1519 may be configured to process image data 1580 (e.g. images, or imaging data), such as medical images obtained from one or more imaging data sources, a treatment device 1550 and / or an image acquisition device 1540.

[0219] Image processing circuitry 1519 may be configured to process, or pre-process, image data. For example, image processing circuitry 1519 may convert received image data into a particular format, size, resolution or the like. In some implementations, image processing circuitry 1519 may be combined with controller circuitry 1511.

[0220] In some implementations, the system 1500 may further comprise an image acquisition device 1540 and / or a treatment device 1550, such as those disclosed herein. The image acquisition device 1540 may be a CT or MRI scanner, for example.

[0221] Image acquisition device 1540 may be configured to output image data 1580, which may be accessed by computing system 1510. Treatment device 1550 may be configured to output treatment data 1560, which may be accessed by computing system 1510.

[0222] Computing system 1510 may be configured to access or obtain treatment data 1560, planning data 1570 and / or image data 1580. Treatment data 1560 may be obtained from an internal data source (e.g. from memory 1513) or from an external data source, such as treatment device 1550 or an external database. Planning data 1570 may be obtained from memory 1513 and / or from an external source, such as a planning database. Planning data 1570 may comprise information obtained from one or more of the image acquisition device 1540 and the treatment device 1550. The various methods described above may be implemented by a computer program. The computer program may include computer code (e.g. instructions) 1610 arranged to instruct a computer to perform the functions of one or more of the various methods described above. The steps of the methods described above may be performed in any suitable order. The computer program and / or the code 1610 for performing such methods may be provided to an apparatus, such as a computer, on one or more computer readable media or, more generally, a computer program product 1600), depicted in Figure 16. The computer readable media may be transitory or non-transitory. The one or more computer readable media 1600 could be, for example, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, or a propagation medium for data transmission, for example for downloading the code over the Internet. Alternatively, the one or more computer readable media could take the form of one or more physical computer readable media such as semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), a rigid magnetic disc, and an optical disk, such as a CD-ROM, CD-R / W or DVD. The instructions 1610 may also reside, completely or at least partially, within the memory 1513 and / or within the controller circuitry 1511 during execution thereof by the computing system 1510, the memory 1513 and the controller circuitry 1511 also constituting computer-readable storage media.

[0223] In an implementation, the modules, components and other features described herein can be implemented as discrete components or integrated in the functionality of hardware components such as ASICS, FPGAs, DSPs or similar devices.

[0224] A "hardware component" is a tangible (e.g., non-transitory) physical component (e.g., a set of one or more processors) capable of performing certain operations and may be configured or arranged in a certain physical manner. A hardware component may include dedicated circuitry or logic that is permanently configured to perform certain operations. A hardware component may comprise a special-purpose processor, such as an FPGA or an ASIC. A hardware component may also include programmable logic or circuitry that is temporarily configured by software to perform certain operations.

[0225] In addition, the modules and components can be implemented as firmware or functional circuitry within hardware devices. Further, the modules and components can be implemented in any combination of hardware devices and software components, or only in software (e.g., code stored or otherwise embodied in a machine-readable medium or in a transmission medium).

[0226] Further components and applicator configurations Figs. 17 to 29 and the following specification depict further components, configurations, options, and associated methods of assembly. The general principles of these components, configurations, options and methods are the same as those depicted and described above in relation to figs. 1 to 16 unless stated to the contrary. As above, the following implementations seek to provide a modular applicator which can be assembled from a kit of components, each with different lengths, sizes, shapes, and features, in order to optimise the assembled applicator for each of a plurality of different potential treatment needs. An advantage of the kits and applicators described herein is that an applicator may be assembled into any of a large number of possible configurations, for example in order to better fit a particular patient's anatomy, to enable more treatment options to be provided, and / or to provide more effective treatment.

[0227] Figures 17a and 17b depict different configurations for components of a brachytherapy kit according to an example of the present invention. As can be appreciated, just as for the cuff segment options and the paravaginal segment options depicted in Figures 2b and 2c respectively, a variety of diameters is provided, along with a variety of options for interstitial needle channels. Each row depicts different options for interstitial needle channels and each column is a different diameter. Each component depicted in figs. 17a, 17b may be generally annular, and comprises a central opening through which the elongate central body can pass, for example an elongate body such as those depicted in fig. 2a, the elongate body depicted in fig. 18a, or as described anywhere else herein.

[0228] In a manner similar to Fig. 2b, Fig. 17a depicts components suitable for placing at the end of an elongate central body. These components are configured to be positioned at a distal end of the elongate central body. As with the components depicted in Fig. 2b, for example the cuff segment 520 depicted in greater detail in Figure 5c, these components have a recess positioned on an inner surface. The recess is shaped, positioned, and configured to interact with an end stopper of the central tube (also referred to herein as an elongate central body).

[0229] In a manner similar to fig. 2c, fig. 17b depicts different options for components which may be positioned further back along the elongate central body, i.e. which are not suitable for positioning at the very end of the elongate central body. These components may be positioned, for example, adjacent along the elongate central body to one of the components depicted in fig. 17a. Figures 18a-c depict various components comprised in a kit suitable for delivering brachytherapy treatment according to an example of the present invention. The kit may comprise an elongate central body 1800 and a plurality of components.

[0230] Figure 18a shows an elongate central body 1800 according to an example of the present disclosure. The elongate central body 1800 has a central body axis which runs through the centre of the elongate central body 1800 parallel to its length. The elongate central body 1800 has a distal end 1815 and an opposite, proximal end (not marked in Fig. 18a). In use, the distal end 1815 is inserted first into a patient. In a manner identical or similar to Figure 5b, the elongate central body 1800 comprises at least one passage to enable passage of a radioactive seed therethrough. The at least one passage may be a central passage. The elongate central body 1800 may comprise an intrauterine tube, similar or identical to those depicted in Fig. 2a. The intrauterine tube may be configured to receive a radioactive seed from the at least one passage of the elongate central body 1800. This enables placement of the radioactive seed at a dwell position inside the patient's uterus, and accordingly extends the various options available for the dwell positions of the radioactive seed.

[0231] The elongate central body 1800 comprises a first alignment structure 1805 positioned on its outer surface and extending along at least a part of its length. The first alignment structure 1805 runs parallel to the length of the elongate central body 1800. The first alignment structure 1805 may be positioned on the underside of the outer surface of the elongate central body 1800 with respect to its orientation in use, however it will be appreciated that the first alignment structure 1805 may be positioned in other configurations with respect to the orientation of the elongate central body in use. According to the present example, the first alignment structure 1805 may comprise a ridge, protrusion or extension, however it will be appreciated that the first alignment structure 1805 may take other configurations such as the configuration depicted in Fig. 5b. In a manner similar to the central tube depicted in Figure 5b, the ridge of the first alignment structure 1805 may comprise a multi-level ridge comprising an alignment portion 1805a and an engagement portion 1805b. The engagement portion 1805b may be located at the distal end 1815 of the elongate central body 1800, and may extend outward from the elongate central body 1800 to a greater degree than the alignment portion 1805a.

[0232] It will be appreciated that the engagement portion 1805b of the multi-level ridge may be identical or similar to the end stopper 512 depicted in Figure 5d. Furthermore, whilst the engagement portion 1805b and the alignment portion 1805a have been described as comprised in one continuous multi- level ridge, it will be appreciated that alternatively the engagement portion 1805b may be comprised in a first ridge and the alignment portion 1805a may be comprised in a second, separate, ridge.

[0233] Figures 18b and 18c depict a first component 1820 and a second component 1825 comprised in the plurality of components according to an example of the invention. The first component 1820 is an example selected from among the plurality of components depicted in fig. 17a, and the second component 1825 is an example selected from among the plurality of components depicted in fig. 17b. The first component 1820 and second component 1825 each comprise a central opening 1830, 1835 through which the elongate central body 1800 can pass. The first component 1820 is configured to be positioned at the distal end 1815 of the elongate central body 1800 and the second component 1825 is configured to be positioned further back along the elongate central body 1800 in a direction parallel to the central axis of the elongate central body 1800, for example adjacent to the first component 1820.

[0234] The first component 1820 and the second component 1825 each comprise one or more features which enable them to be properly positioned and aligned with respect to the elongate central body 1800. The first component 1820 and the second component 1825 each comprise a 'second' alignment structure 1840, 1845, which is referred to as a 'second' alignment structure 1840, 1845 in order to avoid confusion with respect to the 'first' alignment structure 1805 positioned on the elongate central body 1800. The second alignment structure(s) 1840, 1845 are positioned on an inner surface of the respective central openings 1830, 1835. The second alignment structure 1840, 1845 may comprise a recess. The recess of the first component 1820 may be elongated in a direction of a central axis of the first component 1820, and the recess of the second component 1825 may be elongated in a direction of a central axis of the second component 1825. The recess may be configured to interact with the ridge of the first alignment structure 1805 of the central elongate central body 1800 such that the first and second components may be brought into a preferred orientation or alignment with respect to one another on the elongate central body 1800. In this preferred orientation, it will be appreciated that the central axis of the elongate central body 1800, the central axis of the first component 1820, and the central axis of the second component 1825 are aligned when the applicator is assembled.

[0235] In other words, the second alignment structure 1840 of the first component 1820 is configured to interact with the first alignment structure 1805 of the elongate central body 1800 such that the first component 1820 is brought into a preferred orientation with respect to the elongate central body 1800. Furthermore the second alignment structure 1845 of the second component 1825 is configured to interact with the first alignment structure 1805 of the elongate central body 1800 such that the second component 1825 is brought into a preferred orientation with respect to the first component 1820 on the elongate central body 1805.

[0236] The recess of the first component 1820 may be a multi-level recess comprising an alignment portion 1840a and an engagement portion 1840b. The engagement portion 1840b may be recessed to a greater degree than the alignment portion. In other words, the depth of the engagement portion 1840b may be greater than the depth of the alignment portion 1840a. The engagement portion 1840b of the multi-level recess may be configured to interact with the engagement portion 1805b of the multi-level ridge. Similarly, the alignment portion 1840a of the multi-level recess may be configured to interact with the alignment portion 1805a of the multi-level ridge.

[0237] Whilst the engagement portion 1840b and the alignment portion have been described with respect to one continuous recess, it will be appreciated that the engagement portion 1840b may take the form of a second, separate recess positioned on the inner surface of the central opening 1830 of the first component 1820. In this example, the engagement portion 1840b is located adjacent to, but separated from, the alignment portion.

[0238] By providing alignment or engagement features on the elongate central body 1800 and each component of the plurality of components in this way, a clinician can ensure that all components of the modular applicator are orientated correctly with respect to one another during assembly of the applicator. In addition, a greater degree of engagement between each component and the central body 1800 is provided, preventing accidental rotation of the components with respect to the elongate central body 1800 in use. In this way, the clinician has confidence during assembly of the applicator, patient set-up, and treatment itself that the applicator is properly assembled and that the components are properly fixed with respect to one another.

[0239] When a user comes to assemble the applicator, they select an appropriate first component from the kit, e.g. from among the components depicted in fig. 17a. This selection is informed by the patient anatomy and the treatment needs. For example, a first component 1820 with the most appropriate diameter is selected. The selected first component 1820 is fitted onto the elongate central body 1800 such that the alignment structure 1840 of the first component 1820 aligns with the alignment structure 1805 of the elongate central body 1800. The ridge 1805 of the elongate central body 1800 fits into the first, alignment portion 1840a of the first component 1820. This enables the user to slide the first component 1820 along the elongate central body 1800 toward the distal end 1815 of the elongate central body 1800. As the first component 1820 reaches the distal end 1815, the engagement portion, also referred to as an end stopper herein, 1805b enters the engagement portion 1840b of the first component 1820 but is too large to enter the alignment portion 1840a. The end stopper 1805b abuts the small wall or 'step' created in between the engagement portion 1840b and the alignment portion 1840a of the first component 1820. In this way, the first component 1820 is prevented from moving any further axially along the elongate central body 1800, and is fixed in place such that the first component 1820 may not rotate with respect to the elongate central body 1800.

[0240] Once the first component 1820 has been appropriately positioned on the elongate central body 1800, the second component 1825 may be similarly aligned with the elongate central body 1800 and slid axially along the elongate central body 1800 until it is positioned adjacent to, and in contact with, the first component 1820. Depending on the patient's anatomy and treatment needs, multiple other components may be positioned on the elongate central body 1800, for example multiple other 'second' components selected from among those depicted in fig. 17b and / or suitable 'extension' components, until the appropriate applicator has been assembled. The components may optionally be locked in place by a fixation element in a manner described elsewhere herein.

[0241] Figure 19 depicts an assembled modular applicator 1900 configuration comprising the various components described in relation to Figs. 18a-c. The applicator comprises an elongate central body 1905 and a plurality of components. The plurality of components may comprise any of the various components depicted in Fig. 17. The applicator further comprises a first component 1910 located at a distal end 1915 of the elongate central body 1905. The applicator further comprises a second component 1920 located adjacent to the first component 1910 on the elongate central body 1905. As shown in Fig. 19, the kit may further comprise one or more extension components 1925, 1930 configured to be positioned on the elongate central body 1905 adjacent to the second component 1920. The one or more extension components 1925, 1930 may comprise a second alignment structure similar or identical in form to that as described in relation to the second component 1825.

[0242] Whilst the assembled modular applicator 1900 of Figure 19 depicts two extension components, it will be appreciated that a variable number of extension components can be positioned on the elongate central body 1905. In particular, the one or more extension components 1925, 1930 are configured to be removable from the elongate central body 1905 such that the distance between the first component and a most proximal component placed on the elongate central body can be varied. In other words, the number of extension components positioned on the elongate central body can be varied depending on one or both of a patient's anatomy and the patient's treatment plan. For example, a patient being treated for a tumour located within the vaginal wall would require an applicator having a shorter length, and accordingly fewer extension components, than a patient being treated for a tumour within the uterus. By providing the one or more extension components that can be added or removed from the elongate central body, a more personalised modular applicator can be provided that is personalised to both the patient's anatomy and the patient's treatment plan.

[0243] In this implementation of the assembled applicator 1900 the elongate central body 1905 comprises at least one passage to enable passage of a radioactive seed therethrough. The at least one passage may be a central passage. In use, the applicator 1900 is positioned inside the patient's body, and the radioactive seed is moved through the central passage to each of a plurality of dwell positions and held there for durations determined by the patient's brachytherapy treatment plan.

[0244] Turning to Figure 20a, a fixation element 2000 according to the present example is shown. The fixation element 2000 may have a similar configuration to the fixation element 570 depicted in Figures 5h and 5i. The fixation element 2000 is configured to fix a plurality of components, such as the first component 1820, the second component 1825 and one or more extension components 1925, 1930, in place with respect to the elongate central body 1800. The fixation element 2000 comprises a central opening 2005 through which the elongate central body 1800 can pass. The fixation element 2000 further comprises a fixation structure 2010 on an inner surface of the annular fixation element 2000. The fixation structure 2010 takes the form of a ramp or wedge with a flat back face. The fixation structure 2010 is configured to interact with the first alignment structure 1805 of the elongate central body 1800.

[0245] The fixation element 2000 interacts with the elongate central body 1800 in a manner similar to that depicted and described above with respect to figs. 5g, 5h and 5i. To enable the fixation of the plurality of components with respect to the elongate central body 1800 via the fixation element 2000, the first alignment structure 1805 may comprise one or more notches positioned at fixed intervals along at least a part of the length of the elongate central body 1800. An elongate central body 2020 comprising a first alignment structure 2025, comprising one or more notches 2015a, 2015b, 2015c, 2015d, 2015e is illustrated in Figs. 5g and 20b. Turning to Fig. 20b, the one or more notches 2015a-e are configured to interact with the wedge 2010 of the fixation element 2000. By placing the one or more notches 2015a-e at fixed intervals along at least a part of the length of the elongate central body 2025, when an applicator is assembled, it can be ensured that any components selected to be placed over the elongate central body 2025 are positioned correctly. For example, if the selected components are not positioned correctly, the desired position of the fixation element 2000 will not align with a notch 2015a-e on the elongate central body 2025, indicating that the applicator has been incorrectly assembled. Furthermore, by placing one or more notches 2015a- e at fixed intervals along at least a part of the length of the elongate central body 2025, the fixation element can be used with assembled modular applicators having various different numbers of components.

[0246] Figure 21 depicts an example of an assembled applicator 2100 configuration comprising a fixation element 2105 as described above in relation to Fig. 20a. The assembled applicator configuration 2100 corresponds to the applicator configuration 1900 of Figure 19, viewed from a proximal end 2110 of the elongate central body 2115. A proximal end of the central passage 2120 of the elongate central body is also illustrated in this view.

[0247] Figures 22a-22b depict further configurations of the first component 2200a, 2200c and the second component 2200b, 2200d according to an example of the present invention. The first and second components 2200a-d each comprise at least one needle channel 2205a, 2205b, 2205c, 2205d, 2205e extending in the direction of a central axis of the first component 2200a, 2200c and the second component 2200b, 2200d. The at least one needle channel 2205a-e is configured to guide a needle. The needle is guided substantially parallel to the central axis of the elongate central body 1800. Alternatively, or additionally, the needle may be guided to form an angle offset from, and oblique to, the central axis of the elongate central body 1800.

[0248] For example, the first component 2200c may comprise at least one needle channel 2205d configured to guide a needle to form an angle offset from, and oblique to, a central axis of the elongate central body. Additionally or alternatively, the second component may comprise at least one needle channel configured to guide a needle to form an angle offset from, and oblique to, a central axis of the elongate central body 1800. As described in relation to the first component 2200a, 2200c and the second component 2200b, 2200d, the one or more extension components may also comprise at least one needle channel.

[0249] Figure 23a depicts a configuration of an assembled applicator 2300 according to an example of the present invention. The assembled applicator 2300 comprises components selected from a kit, for example the components depicted in figs, 17a and 17b. As with other applicators described herein, the applicator 2300 comprises an elongate central body 2310 and a plurality of components each comprising a central opening through which the elongate central body 2310 can pass, such that the plurality of components can be positioned over the elongate central body 2310.

[0250] The plurality of components comprises a first component 2320 and a second component 2330. The first component 2320 is configured to be positioned at a distal end 2325 of the elongate central body 2310 and the second component 2330 is configured to be positioned further back along a central axis of the elongate central body 2310, for example, adjacent to the first component 2320 on the elongate central body 2310.

[0251] At least one of the first component 2320 and the second component 2330 comprises at least one needle channel 2340. The at least one needle channel 2340 is comprised of an angled needle channel and is configured to guide a needle out from the component at an angle oblique to a central axis of the elongate central body 2310. Guiding the needle to form an angle offset from, and oblique to, the central axis may comprise guiding the needle to extend out from an outer surface of the first component 2320 or the second component 2330. By providing at least one angled needle channel 2340 to guide a needle out from the component, a greater number of dwell positions for a radioactive seed may achieved. This enables more targeted treatment that can help to avoid healthy tissue.

[0252] In addition to the angled needle channels described above, the first component 2320 and second component 2330 may each comprise at least one further needle channel 2345 , the at least one further needle channel 2345 being configured to guide a needle substantially parallel to the central axis of the elongate central body 2310. The at least one further needle channel 2345 is positioned radially closer to the central axis than the at least one angled needle channel 2340. In this way, a needle may be guided out of the modular applicator 2300 either parallel to the central axis of the elongate central body 2310, or at an oblique angle to the central axis. This enables needles to be placed in a more targeted manner that better aligns with the patient's anatomy and / or treatment needs.

[0253] In other words a first component may comprise a combination of one or more needle channels configured to guide a needle parallel to the central axis of the elongate central body and one or more needle channels that are configured to guide a needle at an oblique angle to the central axis of the elongate central body. In this way, needles may be placed such that radioactive seeds housed in the respective needles may be placed at different dwell positions within the patient. These dwell positions may depend on the anatomy of the patient and the patients treatment plan.

[0254] Similarly, the second component may comprise a combination of one or more needle channels configured to guide a needle parallel to the central axis of the elongate central body and one or more needle channels that are configured to guide a needle at an oblique angle to the central axis of the elongate central body. In this way, needles may be placed such that radioactive seeds housed in the respective needles may be placed at different dwell positions within the patient. These dwell positions may depend on the anatomy of the patient and the patients treatment plan.

[0255] Alternatively, a first component may comprise one or needle channels that are configured to guide a needle parallel to the central axis of the elongate central body, without any further needle channels configured to guide a needle out of the applicator at an oblique angle to the central axis of the elongate central body of the applicator.

[0256] Similarly any of the second component and the one or more extension components may comprise one or needle channels that are configured to guide a needle parallel to the central axis of the elongate central body, without any further needle channels configured to guide a needle out of the applicator at an oblique angle to the central axis of the elongate central body of the applicator.

[0257] Overall, this enables a patient's treatment to be tailored to their specific treatment requirements and ensures accurate treatment delivery.

[0258] Furthermore, when more than one angled needled channel is present in the first and / or second component, the angulation of these needle channels may vary with respect to one another. For example, a first needle channel may guide a needle at a first oblique angle with respect to the elongate central body 2310 and a second needle channel may be configured to guide a needle at a second, larger or smaller oblique angle than the first oblique angle with respect to the elongate central body 2310. Various configurations of needle placement and angulation are depicted in Figure 4. By providing different options for needle placement, the applicator enables a radioactive seed to be positioned at different locations, in turn enabling different treatment options and improving the options available to clinicians.

[0259] The elongate central body 2310 may comprise the first alignment structure depicted in Fig. 18a. Similarly, the first component 2320 may comprise the second alignment structure depicted in Fig. 18b, and the second component 2330 may comprise the second alignment structure depicted in Fig. 18c. In this way, the first component 2320 and the second component 2330 can be brought into a preferred orientation with respect to the elongate central body 2310.

[0260] In such a preferred orientation, a needle channel comprised in the first component 2320 and a needle channel comprised in the second component 2330 are brought into alignment with one another to enable a needle to pass through the channel from the first component into the second component.

[0261] For example, the first component may comprise at least one angled needle channel and the second component may comprise a corresponding needle channel that is configured to guide a needle parallel to the central axis of the elongate central body. When the first component and the second component are brought into the preferred orientation, the corresponding needle channel of the second component aligns with the at least one angled needle channel of the first component such that a needle may be passed through the corresponding needle channel into the angled needle channel of the first component and out from the first component at an angle oblique to the central axis of the elongate central body.

[0262] In other words, the provision of the first alignment structure and the second alignment structure ensures that one or more needle channels comprised in the first component and one or more needle channels comprised in the second component are orientated correctly with respect to the elongate central body, and subsequently with respect to each other. This ensures that a needle is able to pass through the aligned channels of the first component and the second component and out of the applicator. The applicator may further comprise one or more extension components 2350, 2355 configured to be positioned on the elongate central body 2310 at a position adjacent to the second component 2330. Similarly to the first and / or second component, the at least one extension component 2350, 2355 may comprise at least one angled channel (not shown) configured to guide a needle out from the at least one extension component at an angle oblique to the central axis of the elongate central body. The one or more extension components 2350, 2355 may further comprise at least one further needle channel configured to guide a needle parallel to the central axis of the elongate central body 2310. The one or more extension components may further comprise a second alignment structure as described in relation to Fig. 18c to enable orientation and alignment of the one or more extension components 2350, 2355 as described above in relation to the first component 2320 and the second component 2330. In this way, the first component 2320, the second component 2330 and the one or more extension components can be brought into a preferred orientation with respect to the elongate central body 2310.

[0263] In such a preferred orientation, a needle channel comprised in the first component 2320, a needle channel comprised in the second component 2330, and a needle channel comprised in the one or more extension components 2350, 2355 are brought into alignment with one another to enable a needle to pass through the channel from the one or more extension components, to the second component and to the first component.

[0264] Figure 23b depicts another example of an assembled applicator configuration 2360 according to the present invention.

[0265] The applicator configurations 2300, 2360 according to Figures 23a-23b may further comprise the fixation element 2000 as described in relation to Figure 20a.

[0266] Turning to Figures 24a-24c, the plurality of components may further comprise a perineal template component, such as one of different perineal template component options 2400a. 2400b, and 2400c. Each of the perineal template component options 2400a-c comprises a central opening 2405a-c configured to receive an extension component of the one or more extension components.

[0267] Fig. 24a depicts a perineal template component 2400a. Perineal template component 2400a comprises a central annular structure defining the central opening 2405a. Two extending handle portions extend outward from the central annular structure. The two extending handle portions have a generally trapezoidal profile that narrows toward the distal ends. The extending handle portions are used for the purpose of securing the applicator with respect to the patient once it has been inserted into the patient. For example, bandages or other securement elements may be wrapped around or otherwise fastened to the extending handle portions and then tied around the patient's anatomy and / or around structure in the treatment room to ensure that the applicator is secured in the desired position.

[0268] Figs. 24b-c depict perineal template components 2400b, 2400c. Perineal template components 2400b, 2400c comprise a substantially planar plate, the substantially planar plate comprising a plurality of apertures. The plurality of apertures 2410, 2420 are configured to guide a needle therethrough. The plurality of apertures 2410, 2420 may be configured to guide a needle parallel to a central axis of the perineal template components 2400b, 2400c. The perineal template component 2400b further comprises one or more ridges 2430 located on an inner surface of the central opening 2405b of the perineal template component 2400b. The one or more ridges 2430 may be configured to interact with a third alignment component comprised in at least one of the second component and the one or more extension components. The one or more ridges 2430 may also be referred to herein as a fourth alignment structure. Whilst the one or more ridges 2430 have been described in relation to the perineal template component 2400b of Fig. 24b, it will be appreciated that the one or more ridges 2430 may also be comprised in any of the other perineal template configurations described herein.

[0269] Figure 24d depicts an extension component 2450 comprising the third alignment 2455 structure described herein. The third alignment 2455 structure may be located on the outer surface of the second component and the one or more extension components 2450 respectively, and may be elongated in the direction of the central opening 2460 of the extension component. The third alignment structure 2455 may comprise one or more recesses such that the one or more recesses are configured to interact with the one or more ridges 2430 of the perineal template structure 2400b.

[0270] Figure 24e depicts an enlarged view of an applicator 2470 depicting the interaction of the third alignment structure 2455 with the fourth alignment structure 2430 of the perineal template component 2400b. In this example, the applicator 2470 comprises a second component 2465a and two extension components 2465b, 2465c, however it will be appreciated that the applicator may comprise any number of extension components. As shown in Fig. 24e, the third alignment structure 2455 on each of the second component 2465a and the extension components 2465b, 2465c align with one another to form a continuous channel. The respective third alignment structures 2455 may be brought into this preferred alignment through the interaction of the first alignment structure 1805 and the second alignment structures 1820 described in relation to Fig. 18. The one or more ridges 2430 of the perineal template structure 2400b are located in the one or more ridges of the third alignment structures 2455 of each of the extension components 2465a-c respectively. By providing the third alignment structures having a configuration as described herein, it is ensured that the perineal template is placed onto the applicator in a preferred orientation. This is particularly beneficial when the perineal template comprises a plurality of needle channels, as it can be ensured that needles are placed accurately in the respective channels of the perineal template in accordance with a treatment plan, for example. This increases dosage accuracy and reduces the risk of healthy tissue being irradiated.

[0271] Figures 25a-25c depict assembled applicator configurations 2500a-c comprising the perineal template components 2400a-c discussed in relation to Figures 24a-24c.

[0272] Turning specifically to the configuration of Fig. 25b, a modular applicator 2500b comprising the various components described in relation to Figs. 18a-c is shown that is suitable for delivering brachytherapy treatment. The applicator 2500b comprises an elongate central body 2510 and a plurality of components each comprising a central opening through which the elongate central body 2510 can pass. The plurality of components comprise a first component 2520 configured to be positioned at a distal end 2505 of the elongate central body 2510, and a second component 2535 configured to be positioned on the elongate central body adjacent to the first component 2520. The plurality of components further comprise one or more extension components 2530 configured to be positioned on the elongate central body 2510. In this example, the one or more extension components 2530 are positioned adjacent to the second component 2535.

[0273] The applicator 2500b further comprises a perineal template component 2540 comprising a plurality of apertures 2550 each configured to guide a needle therethrough. The central opening of the perineal template component 2540 is configured to receive one of the one or more extension components 2530, such that when the applicator is assembled, the perineal template component 2540 is positioned on one of the one or more extension components 2530. When the perineal template component 2540 is positioned in this way, the perineal template component 2540 extends radially out from the elongate central body, such that the plate extends substantially perpendicular to a central axis of the elongate central body 2510. In this way, each of the apertures 2550 of the perineal template component 2540 are arranged around the elongate central body 2510 Whilst the applicator 2500b depicted in Fig. 25b comprises the perineal template component 2400b of Figure 24b, it will be appreciated that any suitable alternative perineal template component described herein may be used. The applicator 2500b may further comprise a fixation element described in accordance with Fig. 20a.

[0274] Whilst the assembled modular applicator 2500b depicts two extension components, it will be appreciated that a variable number of extension components can be positioned on the elongate central body 2510. In particular, the one or more extension components 2530 are configured to be removable from the central elongate body 2510 such that the distance between the first component and a most proximal component placed on the elongate central body 2510 can be varied. In other words, the number of extension components positioned on the elongate central body 2510 can be varied depending on one or both of a patient's anatomy and the patient's treatment plan. For example, a patient being treated for a tumour located within the vaginal wall would require an applicator having a shorter length, and accordingly fewer extension components, than a patient being treated for a tumour within the uterus. Furthermore, the number of extension components on the elongate central body may be varied depending on a required distance between the first, distal component 2520 and the perineal template component 2540. In this way the perineal template component 2540 can be positioned at different distances from the distal end of the elongate central body 2510 such that different patient anatomy sizes and different required depths of insertion of the applicator be accommodated for. Overall, by providing the one or more extension components that can be added or removed from the elongate central body, a more personalised modular applicator can be provided that is personalised to both the patient's anatomy and the patient's treatment plan.

[0275] Whilst the Figures and accompanying description illustrate the perineal template component configured to be positioned over one of the one or more extension components, in another example, the perineal template component may comprise other means of being positioned on the elongate central body. For example, the perineal template component may comprise an integral component having a central opening configured to receive an elongate central body therethrough. In this example, the perineal template component may be positioned on the elongate central body adjacent to a most proximal component on the elongate central body. Whilst the examples herein have been described with respect to an elongate central body having at least one, central, passage, it will be appreciated that the elongate central body may alternatively comprise a plurality of channels.

[0276] Figure 26 depicts an elongate central body 2600 according to the present example and illustrates a plurality of passages 2610a, 2610b, 2610c, 2610d comprised in the elongate central body 2600. The plurality of passages 2610a, 2610c, 2610d may be arranged at fixed intervals about a central passage 2160b of the elongate central body 2610. The plurality of passages are each configured to enable passage of a radioactive seed therethrough.

[0277] Fig. 27a also depicts an elongate central body 2700. In a similar manner to Fig. 26, the elongate central body 2700 comprises a plurality of passages 2710a-d. As shown in Figure 27a, at least one of the plurality of passages 2710a-d may be configured to guide a needle 27150 therethrough, wherein the needle 2715 is configured to enable passage of a radioactive seed therethrough. In this configuration, a guiding tube is also provided such as the guiding tube depicted in Figures 12a and 12b. The configuration of the guiding tube as described herein, beneficially enables a guiding tube and needle to be inserted into the central tube 2600, after the central tube has been inserted into a patient for example. Additionally or alternatively, at least one of the plurality of passages 2710a-d may be configured to guide a catheter 2720 therethrough, wherein the catheter 2720 is configured to enable passage of a radioactive seed therethrough. The catheter may be comprised in the kit for a modular brachytherapy applicator described herein. Specifically, the kit may comprise at least one catheter.

[0278] Figure 27b depicts an enlarged view of the elongate central body 2700 comprising the plurality of passages 2710a-d. The passage comprises a region of increased diameter 2730 located at a predetermined distance from a distal end of the elongate central body.

[0279] Figure 27c depicts a catheter 2735 according to the present invention. As depicted in Figures 27b- 27c, the catheter 2735 comprises a collar 2725a on its outer surface. The collar 2725a may be positioned at a predetermined distance from a distal end of the catheter to provide a region of catheter having an increased diameter. The predetermined distance may be greater than the predetermined distance described in relation to the region of increased diameter of the passage. The collar may be resiliently collapsible such that when the catheter is inserted into the at least one passage, the collar is resiliently deformed to enable traversal of the catheter through the at least one passage until the collar reaches the region of increased diameter within the at least one passage. When the collar reaches the region of increased diameter it is able to expand within the region of increased diameter and provide a resistance to further traversal of the catheter through the at least one channel. In this way, the collar is configured to mechanically hold the catheter 2720 in place inside the passage such that the catheter 2720 does not contact a patient when placed in the passage.

[0280] The catheter may comprise a further one or more collars 2725b, 2725c configured to mechanically hold the catheter 2735 in place inside the passage. For example a collar may be located on the catheter 2735 externally to the passage and held via a fixation means located outside of the passage on the elongate central body 2700. The number of collars placed around the catheter 2720 may vary depending on the configuration of the applicator. For example, an applicator that comprises more than one extension component may comprise more collars than an applicator configuration having a single extension component. The catheter configuration described herein enables the catheter 2735 to be positioned within the passage to a degree such that it emerges from the distal end of the elongate central portion to a certain (pre-determined) degree, thereby ensuring repeatable catheter placement and improved patient safety by ensuring consistent and accurate radiation dosage. For example, the collars are particularly advantageous when the catheter is intended to be placed below the surface of the passage opening as depicted in Figure 27b. In this way, the catheter 2735 may be secured in this position without contacting the patient.

[0281] Figure 28 depicts an assembled applicator 2800 according to the present example. The applicator 2800 comprises an elongate central body 2805 comprising a plurality of passages 2810a, 2810b, 2810c, 2810d. The applicator further comprises a fixation element 2815. The fixation element 2815, may be similar or identical to the fixation element 2000 described in relation for Fig. 20a The applicator may further comprise other components described herein and is not limited to the configuration described.

[0282] Figure 29 depicts an example of a method 2900 of assembling a modular applicator according to the present disclosure. The method may be performed by a user such as a clinician before brachytherapy treatment is to take place. The method begins at step 2910 where an elongate body is selected from a plurality of elongate central bodies. The plurality of elongate bodies may comprise any one of the elongate central bodies described according to the present disclosure. For example, the kit may comprise one or more of the options depicted in figure 2a. The user selects an elongate central body or tube according to the patient's anatomy and treatment needs.

[0283] At step 2920 a first component is selected from the plurality of components. The first component selected may comprise any one of the first components depicted in Figure 2b or 17a, for example. Again, the user makes the selection according to the patient's anatomy and treatment needs.

[0284] At step 2930 the selected first component is positioned at a distal end of the selected elongate central body. The positioning may comprise sliding the first component over the elongate central body to a distal end of the elongate central body, and then rotating the first component around the elongate central body such that the first alignment structure of the elongate central body is in alignment and interacts with the second alignment structure of the first component. Alternatively, the positioning may comprise rotating the first component such that the second alignment structure of the first component and the first alignment structure of the elongate central body are in alignment with one another, and sliding the aligned first component over the elongate central body to a distal end of the elongate central body. The first component may be slid over the elongate central body until the engagement portion of the recess comprised in the second alignment structure aligns, and interacts with, the engagement portion of the ridge comprised in the first alignment structure.

[0285] At step 2940 a second component is selected from the plurality of components. The second component may comprise any one of the second components depicted in Fig. 17, for example. Again, the user makes the selection according to the patient's anatomy and treatment needs.

[0286] At step 2950 the selected second component is positioned on the elongate central body, adjacent to the first component. Similarly to the first component, the positioning may comprise sliding the second component over the elongate central body, and rotating the second component around the elongate central body such that the first alignment structure of the elongate central body aligns and interacts with the second alignment structure of the second component. Alternatively, the positioning may comprise rotating the second component such that the second alignment structure of the second component and the first alignment structure of the elongate central body are in alignment with one another, and sliding the aligned second component over the elongate central body to a position adjacent to the first component on the elongate central body. In this position the first component and the second component may be in a preferred orientation with respect to one another and the elongate central body.

[0287] The method may further optionally comprise determining, based on the patient's anatomy and / or the patient's treatment needs, a required number of extension components to be positioned on the elongate central body adjacent to the second component. For example, a patient being treated for a tumour in the vaginal wall may require fewer extension components in an assembled applicator than a patient being treated for a tumour in the uterus. The method may further comprise positioning the required number of extension components on the elongate central body. The positioning may comprise sliding the one or more extension components over the elongate central body to a position adjacent to the second component and rotating the one or more extension components around the elongate central body such that the first alignment structure of the elongate central body is in alignment and interacts with the second alignment structure of the one or more extension components. Alternatively, the positioning may comprise rotating the one or more extension components such that the second alignment structure of the one or more extension components and the first alignment structure of the elongate central body are in alignment with one another, and sliding the aligned one or more extension components over the elongate central body to a position adjacent to the second component on the elongate central body.

[0288] In another example, the method may further optionally comprise selecting a perineal template component from a plurality of perineal template components and determining, based on the patient's anatomy and / or the patient's treatment needs, a required distance from the distal end of the elongate central body to the perineal template component. The method may further optionally comprise determining, based on the required distance, a required number of extension components to be positioned between the first component and the perineal template component, and positioning the required number of extension components on the elongate central body, and positioning the perineal template component on the extension component. The positioning of the perineal template component may comprise sliding the selected perineal template component over the one or more extension components to the required distance, and rotating the perineal template component such that the ridges comprised in the perineal template component align and interact with the third alignment structure of one of the one or more extension components. In this configuration the perineal template component may be brought into a preferred orientation with respect to the selected first component, the selected second component and the selected one or more extension components on the elongate central body.

[0289] The method may further optionally comprise positioning a fixation element on the elongate central body at a position adjacent to the selected plurality of components.

[0290] It will be appreciated that steps of the above methods may be omitted, or the method may be performed in a differing order to that of Fig. 29.

[0291] The computer-implemented method of Figure 14 may also be implemented with respect to the various components and configurations described with respect to Figures 18-28. Referring to Figure 14, at step 1410, information is received regarding treatment needs of a patient. The received information may comprise information regarding the location, orientation, and shape of one or more tumours. Additionally or alternatively, the received information may comprise information regarding the location, orientation and shape of one or more organs at risk (OARs). Additionally, or alternative the received information may comprise information regarding the type of cancer and / or the caner diagnosis. The received information may additionally or alternatively comprise medical information associated with the patient and / or dose information as prescribed by a clinician or in accordance with an existing treatment plan.

[0292] At step 1420 the received information may be processed, and at step 1430, an optimal applicator configuration is outputted based on the received information and processing. The outputting may comprise using a trained machine learning model. The optimal applicator configuration comprises a recommended elongate central body selected from a plurality of elongate central body options, a recommended first or distal component selected from a plurality of distal components for attaching to the elongate central body, and at least one recommended extension component for attaching to the elongate central body selected from a plurality of extension components. The number of recommended extension components may depend on the anatomy and the treatment needs of the patient. For example, a patient being treated for a tumour in the vaginal wall may require fewer extension components in an assembled applicator than a patient being treated for a tumour in the uterus.

[0293] The recommended distal component and the recommended at least one extension component may comprise a plurality of needle channels, each needle channel being configured to guide a needle therethrough. In this example, the output may further comprise one or more recommended needle channels of the distal component and the one or more extension components to place the needles in.

[0294] It will be appreciated that the required angulation of the needles may vary depending on the treatment needs and the anatomy of the patient. Accordingly, the optimal applicator configuration output further comprises a recommended angulation of the one or more needles with respect to a central axis of the recommended elongate central body.

[0295] The optimal applicator configuration may further comprise a recommended perineal template component selected from a plurality of perineal template components. For example, the plurality of perineal template components may comprise any one of the perineal template components described herein.

[0296] In some examples, the method may further comprise generating one or more recommended configurations for a 3-d printable component such as a shape of the recommended distal component, a size of the recommended distal component and a shape of the recommended perineal template component. Based on these recommended 3-D printable component configurations, the method may further comprise generating instructions for a 3d printing device.

[0297] Returning the Figure 14, the method may further comprise generating and / or outputting a treatment based on the received information and the optimal applicator configuration. The treatment plan may comprise any one or more of a location of a radioactive source along a specified channel, a recommended dwell time of the radioactive source, a recommended type of radioactive source or a recommended number of radioactive sources.

[0298] It will be appreciated that the modular applicators described herein may comprise further components and are not limited to the configurations described herein.

[0299] Unless specifically stated otherwise, as apparent from the following discussion, it is appreciated that throughout the description, discussions utilizing terms such as " receiving", "determining", "comparing ", "enabling", "maintaining," "identifying," or the like, refer to the actions and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices. It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other implementations will be apparent to those of skill in the art upon reading and understanding the above description. Although the present disclosure has been described with reference to specific example implementations, it will be recognized that the disclosure is not limited to the implementations described, but can be practiced with modification and alteration within the spirit and scope of the appended claims. Accordingly, the specification and drawings are to be regarded in an illustrative sense rather than a restrictive sense. The scope of the disclosure should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

Claims1. A kit for a modular applicator, the applicator being suitable for delivering brachytherapy treatment, the kit comprising: an elongate central body comprising a first alignment structure on its outer surface and extending along at least a part of its length; a plurality of components each comprising a central opening through which the elongate central body can pass, the plurality of components comprising: a first component configured to be positioned at a distal end of the elongate central body; and a second component configured to be positioned on the elongate central body adjacent to the first component; wherein each of the first and the second component comprises a second alignment structure positioned on an inner surface of the respective central openings; wherein interaction of the first alignment structure of the elongate central body with the second alignment structure of each of the first and second component brings the first and second component into a preferred orientation with respect to one another on the elongate central body.

2. The kit of claim 1, wherein the elongate central body comprises at least one passage to enable passage of a radioactive seed therethrough.

3. The kit of claim 1, wherein the at least one passage is a plurality of passages, each configured to enable passage of a radioactive seed therethrough.

4. The kit of claim 2 or claim 3, wherein the at least one passage is configured to guide a needle or catheter therethrough.

5. The of kit of claim 4, wherein the needle or catheter is configured to enable passage of the radioactive seed therethrough.

6. The kit of any of claims 2 to 5, wherein the kit further comprises at least one catheter, each catheter comprising a collar on its outer surface, wherein the collar ispositioned at a first predetermined distance from a distal end of the catheter and provides a region of catheter having an increased diameter.

7. The kit of claim 6, wherein the collar is resiliently collapsible.

8. The kit of claim 6 or claim 7 , wherein the at least one passage comprises a region of increased diameter at a second predetermined distance from a distal end of the elongate central body, the second predetermined distance being less than the first predetermined distance.

9. The kit of claim 8, wherein the catheter and at least one passage are configured such that, during insertion of the catheter into the at least one passage, the collar is resiliently deformed to enable traversal of the catheter through the at least one passage until the collar reaches the region of increased diameter within the at least one passage, thereby enabling the collar to expand within the region of increased diameter and provide resistance to further traversal of the catheter through the at least one channel.

10. The kit of any preceding claim, wherein the first alignment structure extends in a direction parallel with a central axis of the elongate central body.

11. The kit of any preceding claim, wherein the elongate central body further comprises an end stopper located at a distal end of the elongate central body, wherein the end stopper is configured to engage the first component.

12. The kit of any preceding claim, wherein the first alignment structure comprises a ridge and the second alignment structure of each of the first and second component comprises a recess, wherein the recesses are configured to interact with the ridge of the first alignment structure such that the first and second components are brought into the preferred orientation with respect to one another on the elongate central body.

13. The kit of claim 12 wherein the recess of the first component is elongated in a direction of a central axis of the first component, and the recess of the second component is elongated in a direction of a central axis of the second component, wherein the central axesof the elongate central body, first component, and second component are aligned when the applicator is assembled.

14. The kit of claim 12 or claim 13, wherein the recess of the first component is a multilevel recess, wherein the muti-level recess comprises an alignment portion and an engagement portion, the engagement portion being recessed to a greater degree than the alignment portion.

15. The kit of claim 14, wherein the ridge comprises a multi-level ridge comprising an alignment portion and an engagement portion, the engagement portion extending outward from the elongate central body to a greater degree than the alignment portion, and wherein the engagement portion of the multi level ridge is configured to engage with the engagement portion of the multi-level recess.

16. The kit of any preceding claim, wherein the first component and the second component each comprise at least one needle channel.

17. The kit of claim 16, wherein the at least one needle channel in the first component and the at least one needle channel in the second component align when the first component and the second component are brought into the preferred orientation.

18. The kit of claim 17, wherein, when the first component and second component are in the preferred orientation, a needle may be passed through the at least one needle channel in the first component and the at least one needle in the second component.

19. The kit of any of claims 16 to 18, wherein the at least one needle channel of the first and second component is configured to guide the needle substantially parallel to a central axis of the elongate central body.

20. The kit of claim 19, wherein the at least one needle channel in the first component and / or the at least one needle in the second component is configured to guide the needle to form an angle offset from, and oblique to, a central axis of the elongate central body.

21. The kit of claim 20, wherein guiding the needle to form an angle offset from, and oblique to, the central axis comprises guiding the needle to extend out from an outer surface of the first or second component.

22. The kit of any preceding claim, wherein the plurality of components further comprises one or more extension components, wherein the one or more extension components are each configured to be positioned on the elongate central body.

23. The kit of claim 22, wherein each of the one or more extension components comprises a second alignment structure positioned on an inner surface of its central opening, wherein interaction of the first alignment structure of the elongate central body and the second alignment structure of an extension component brings the extension component into the preferred orientation with respect to the first and second component on the elongate central body.

24. The kit of claim 23, wherein the one or more extension components each comprise at least one needle channel, wherein the at least one needle channel in the extension components is configured to align with the at least one needle channel in the first and second components respectively when each of the first component, the second component and the one or more extension components are positioned in the preferred orientation.

25. The kit of any preceding claim, wherein the plurality of components further comprises a perineal template component comprising a substantially planar plate, the substantially planar plate comprising a plurality of apertures each configured to guide a needle therethrough.

26. The kit of claim 25, wherein, when the perineal template component is positioned on the elongate central body, the perineal template component extends radially out from the elongate central body such that the plate extends substantially perpendicular to a central axis of the elongate central body.

27. The kit of claim 25 or claim 26, wherein each of the apertures of the perineal template component is configured to guide a needle parallel to the central axis of the elongate central body.

28. The kit of any of claims 25 to 27 , wherein when the perineal template component is positioned on the elongate central body, the apertures of the plurality of apertures are arranged around the elongate central body.

29. The kit of any of claims 25 to 28, wherein at least one of the second component and the one or more extension components comprises third alignment structure located on an outer surface; and the perineal template component comprises fourth alignment structure located on an inner surface of the central opening of the perineal template component; and wherein interaction of the third alignment structure of the second component or extension component and the fourth alignment structure of the perineal template component brings the component into a preferred orientation with respect to one another on the elongate central body.

30. The kit of any preceding claim, further comprising a fixation element comprising a central opening through which the elongate central body can pass, the fixation element configured to fix the plurality of components in place with respect to the elongate central body.

31. The kit of claim 30, wherein the first alignment structure further comprises one or more notches positioned at fixed intervals along at least of the length of the elongate central body; and wherein the fixation element comprises a wedge located on an inner surface of its central opening, the wedge configured to interact with one of the one or more notches of the first alignment structure.

32. The kit of claim 2, wherein the elongate central body comprises an intrauterine portion configured, in use, to enter the patient's uterus, wherein the intrauterine portion is configured to receive a radioactive seed via the at least one passage.

33. The kit of any preceding claim, further comprising: a plurality of options for the first component, each having a different diameter,a plurality of options for the second component, each having one of the different diameters.

34. A modular applicator suitable for delivering brachytherapy treatment, the applicator comprising: an elongate central body comprising a first alignment structure on its outer surface and extending along at least a part of its length; a plurality of components affixed to the elongate central body, each comprising a central opening; wherein the elongate central body is positioned through the central opening of each of the plurality of components; the plurality of components comprising: a first component positioned at a distal end of the elongate central body; and a second component positioned on the elongate central body adjacent to the first component; wherein each of the first and second component comprises a second alignment structure positioned on an inner surface of the respective central openings; and wherein interaction of the first alignment structure of the elongate central body with the second alignment structure of each of the first and second component defines a preferred orientation of the first and second component with respect to one another on the elongate central body.

35. The modular applicator of claim 34, wherein the modular applicator is assembled from the kit of any of claims 1 to 33.

36. A method of assembling a modular applicator, the applicator suitable for delivering brachytherapy treatment, the method comprising: selecting an elongate central body from a plurality of elongate central bodies, wherein the elongate central body comprises a first alignment structure located on its outer surface and extending along at least a part of its length; selecting a first component from a plurality of components, wherein each of the plurality of components comprises a central opening through which the elongate central body can pass; positioning the first component at a distal end of the elongate central body;selecting a second component from the plurality of components; positioning the second component on the elongate central body adjacent to the first component; wherein each of the first component and the second component comprises a second alignment structure positioned on an inner surface of the respective central openings, and wherein interaction of the first alignment structure of the elongate central body with the second alignment structure of each of the first and second component brings the first and second component into a preferred orientation with respect to one another on the elongate central body; the method further comprising bringing the first and second component into the preferred orientation on the elongate central body.

37. The method of claim 36, further comprising selecting one or more extension components from the plurality of components,; positioning the one or more extension components on the elongate central body adjacent to the second component; and bringing the one or more extension components into the preferred orientation on the elongate central body.

38. The method of claim 37 further comprising selecting a perineal template component from the plurality of components; and positioning the selected perineal template component over the elongate central body.

39. The method of any of claims 36 to claim 38, further comprising positioning a fixation element over the elongate central body to affix the position of the selected plurality of components with respect to the elongate central body.

40. A kit for a modular applicator, the applicator being suitable for delivering brachytherapy treatment, the kit comprising: an elongate central body; a plurality of components each comprising a central opening through which the elongate central body can pass, the plurality of components comprising:a first component configured to be positioned at a distal end of the elongate central body; and a second component configured to be positioned on the elongate central body adjacent to the first component, wherein at least one of the first and second component comprises at least one angled needle channel, the at least one angled needle channel being configured to guide a needle out from the component at an angle oblique to a central axis of the elongate central body.

41. The kit of claim 40, wherein the elongate central body comprises at least one passage to enable passage of a radioactive seed therethrough.

42. The kit of claim 41, wherein the at least one passage is a plurality of passages, each configured to enable passage of a radioactive seed therethrough.

43. The kit of any of claims 40 to 42, wherein the first and the second component each further comprise at least one further needle channel, the at least one further needle channel being configured to guide a needle parallel to the central axis of the elongate central body.

44. The kit of claim 43, wherein the at least one further needle channel is positioned radially closer to the central axis than the at least one angled needle channel.

45. The kit of any of claims 40 to 43, wherein the plurality of components further comprises one or more extension components, wherein the one or more extension components are each configured to be positioned on the elongate central body .

46. The kit of claim 44, wherein at least one of the one or more extension components comprises at least one angled needle channel, the at least one angled needle channel being configured to guide a needle out from the at least one extension component at an angle oblique to a central axis of the elongate central body.

47. The kit of claim 46, wherein the one or more extension components further comprise at least one further needle channel, the at least one further needle channel of each of theone or more extension components respectively being configured to guide a needle parallel to the central axis of the elongate central body.

48. The kit of any preceding claim further comprising a fixation element configured to be positioned on the elongate central body, the fixation element being configured to secure the plurality of components with respect to the elongate central body.

49. The kit of any preceding claim, wherein the elongate central body comprises a first alignment structure on its outer surface that extends along at least a part of its length; and each of the first and the second component comprises a second alignment structure positioned on an inner surface of their central openings; wherein interaction of the first alignment structure of the elongate central body with the second alignment structure of each of the first and second component brings the first and second component into a preferred orientation with respect to one another on the elongate central body.

50. The kit of claim 49, wherein the first component comprises the at least one angled needle channel; and the second component comprises a corresponding needle channel configured to guide a needle parallel to the central axis of the elongate central body; wherein, when the first and second component are in the preferred orientation, the corresponding needle channel aligns with the at least one angled needle channel such that a needle may be passed through the corresponding needle channel in the second component, into the angled needle channel of the first component, and out from the first component at the angle oblique to the central axis.

51. The kit of claim 50, wherein the at least one angled needle channel is a plurality of angled needle channels, the plurality of needle channels being arranged around the central axis; wherein the second component comprises a plurality of corresponding needle channels arranged such that, when the first and second component are in the preferred orientation, each of the angled needle channels in the first component aligns with a corresponding needle channel of the plurality of corresponding needle channels, such that a plurality ofneedles may be passed through the second component, into the first component, and out from the first component at an angle oblique to the central axis.

52. The kit of any of claims 40 to 51, further comprising a plurality of options for the first component, the plurality of options comprising: a first option component comprising a first angled needle channel configured to guide a needle out from the first option component at a first angle oblique to the central axis of the elongate central body; and a second option component comprising a second angled needle channel configured to guide a needle out from the second option component at a second, different angle oblique to the central axis.

53. A modular applicator suitable for delivering brachytherapy treatment, the applicator comprising: an elongate central body; a plurality of components affixed to the elongate central body, each comprising a central opening; wherein the elongate central body is positioned through the central opening of each of the plurality of components; the plurality of components comprising: a first component configured to be positioned at a distal end of the elongate central body; and a second component configured to be positioned on the elongate central body adjacent to the first component; wherein at least one of the first and second component comprises at least one angled needle channel, the at least one angled needle channel being configured to guide a needle out from at least one of the first and second component at an angle oblique to a central axis of the elongate central body.

54. The modular applicator of claim 53, further comprising the needle positioned within the at least one angled needle channel.

55. The modular applicator of claim 53 or 54, wherein the modular applicator is assembled from the kit of any of claims 1 to 33 or 40 to 52.

56. A method of assembling a modular applicator, the applicator suitable for delivering brachytherapy treatment, the method comprising: selecting an elongate central body from a plurality of elongate central bodies; selecting a first component from a plurality of components, wherein each of the plurality of components comprises a central opening through which the elongate central body can pass; positioning the first component at a distal end of the elongate central body; selecting a second component from the plurality of components; positioning the second component on the elongate central body adjacent to the first component; wherein at least one of the first and second component comprise at least one angled needle channel, the at least one angled needle channel being configured to guide a needle out from at least one of the first and second component at an angle oblique to a central axis of the elongate central body.

57. The method of claim 56, further comprising positioning a needle through the at least one angled needle channel.

58. A kit for a modular applicator, the applicator being suitable for delivering brachytherapy treatment, the kit comprising: an elongate central body; a plurality of components each comprising a central opening through which the elongate central body can pass, the plurality of components comprising: a first component configured to be positioned at a distal end of the elongate central body; a perineal template component comprising a plurality of needle apertures, each aperture being configured to guide a needle therethrough; and a plurality of extension components, each extension component being configured to be positioned on the central elongate body such that a variable number of extension components may be positioned between the first component and the perineal template component, thereby enabling a distance between the distal end of the elongate central body and the perineal template to be varied.

59. The kit of claim 58, further comprising a second component configured to be positioned on the elongate central body adjacent to the first component.

60. The kit of claim 58 or claim 59, wherein the perineal template component comprises a substantially planar plate, the substantially planar plate comprising the plurality of apertures.

61. The kit of any of claims 58 to 60, wherein, when the perineal template component is positioned on the elongate central body, the perineal template component extends radially out from the elongate central body such that the plate extends substantially perpendicular to a central axis of the elongate central body.

62. The kit of any of claims 58 to 61, wherein each of the apertures of the perineal template component is configured to guide a needle parallel to the central axis of the elongate central body.

63. The kit of any of claims 58 to 62, wherein when the perineal template component is positioned on the elongate central body, the apertures of the plurality of apertures are arranged around the elongate central body.

64. The kit of any of claims 58 to 63, further comprising a fixation element configured to be positioned on the elongate central body, the fixation element being configured to secure the plurality of components with respect to the elongate central body.

65. A modular applicator suitable for delivering brachytherapy treatment, the applicator comprising: an elongate central body; a plurality of components affixed to the elongate central body, each comprising a central opening; wherein the elongate central body is positioned through the central opening of each of the plurality of components; the plurality of components comprising: a first component configured to be positioned at a distal end of the elongate central body;a perineal template component comprising a plurality of needle apertures each configured to guide a needle therethrough; and a plurality of extension components, each extension component being removable from the central elongate body such that a variable number of extension components may be positioned between the first component and the perineal template component, thereby enabling a distance between the distal end of the elongate central body and the perineal template to be varied.

66. The applicator of claim 65, wherein the elongate central body comprises at least one passage to enable passage of a radioactive seed therethrough.

67. The modular applicator of claim 65 or 66, wherein the modular applicator is assembled from the kit of any of claims 1 to 33, 40 to 52, or 58 to 64.

68. A method of assembling a modular applicator, the applicator suitable for delivering brachytherapy treatment, the method comprising: selecting a first component from a plurality of components, wherein each of the plurality of components comprises a central opening through which an elongate central body can pass; positioning the first component at a distal end of the elongate central body; selecting a perineal template component from a plurality of perineal template components; determining, based on a patient's anatomy and / or the patient's treatment needs, a required distance from the distal end of the central elongate body to the perineal template component; determining, based on the required distance, a required number of extension components which should be positioned between the first component and the perineal template component; positioning the required number of extension components on the elongate central body; and positioning the perineal template component on the elongate central body.

69. The method of claim 68, wherein positioning the perineal template component on the elongate central body comprises positioning the perineal template component on a selected extension component.

70. The method of claim 68 or claim 69, further comprising positioning a fixation element on the elongate central body adjacent to the plurality of components.

71. A computer-implemented method of generating an optimal applicator configuration, the applicator being suitable for treating a patient via brachytherapy; the method comprising: receiving information regarding treatment needs of the patient; and outputting, based on the received information, an optimal applicator configuration for the patient's brachytherapy treatment; wherein the optimal applicator configuration comprises: a recommended elongate central body selected from a plurality of central elongate body options; a recommended distal component selected from a plurality of distal components for attaching to the elongate central body; and at least one recommended extension component for attaching to the elongate central body selected from a plurality of extension component options.

72. The method of claim 71, wherein the received information regarding the treatment needs of the patient comprise any one or more of: information regarding the location, orientation, and shape of one or more tumours; information regarding the location, orientation, and shape of one or more organs at risk(OARs); information regarding the type of cancer and / or the cancer diagnosis; one or more medical images depicting the patient anatomy; medical information associated with the patient; and dose information as prescribed by a clinician or in accordance with an existing treatment plan.

73. The method of claim 71 or claim 72, wherein outputting the optimal applicator configuration comprises using a trained machine learning model.

74. The method of any of claims 71 to 73, wherein the recommended distal component and the recommended at least one extension component comprise a plurality of needle channels, each needle channel configured to guide an interstitial needle.

75. The kit of any of claims 71 to 73, wherein the optimal applicator configuration further comprises one or more recommended needle channels of the recommended distal component and the at least one recommended extension component to place an interstitial needle in.

76. The method of claim 75, wherein the optimal applicator configuration further comprises a recommended angulation of the one or more needles with respect to a central axis of the recommended elongate central body.

77. The method of any of claims 71 to 76, wherein the optimal applicator configuration further comprises a recommended perineal template component, selected from a plurality of perineal template components.

78. The method of any of claims 71 to 77, further comprising generating one or more recommended configurations for a 3d-printable component.

79. The method of claim 78, wherein the one or more recommended configurations for a 3D printable component comprises: a shape of a recommended distal component; a size of a recommended distal component; and a shape of a recommended perineal template component.

80. The method of any of claims 77 to 79, further comprising generating instructions for a 3d printing device, based on the one or more recommended configurations.

81. The method of any of claims 71 to 80, further comprising, based on the received information, generating a brachytherapy treatment plan which uses the optimal applicator configuration.

82. The method of claim 81, wherein the treatment plan comprises any of: a location of a radioactive source along a specified channel of the optimal applicator configuration, a recommended dwell time of the radioactive source at the recommended location;a recommended type of radiation source; a recommended number of radiation sources.

83. A computer readable medium comprising instructions which when executed by a computer, cause the computer to carry out the steps of any of claims 71 to 82.

84. A computer program product comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps of any of claims 71 to 83.

Citation Information

Patent Citations

  • Myocardial implant with collar

    US20040147868A1

  • Brachytherapy apparatus and methods of using same

    US20100249487A1

  • A rotating shield brachytherapy system

    US20190126064A1