Wearable inserter for reproducibly aligning body tissues for external radiation therapy treatment programs - Patent Application 20070122999

Abstract

A placement tool (200) for assisting in the treatment of a subject in an external radiation therapy program including one or more external radiation therapy treatment sessions includes an inserter (204) having a proximal end (40) and a distal end (20), the inserter configured for insertion through an entrance into a tube (602) connected to body tissue (610) of the subject, the inserter including an elongate member (210) provided with an elongate member lumen (214) configured to receive an effector shaft (310) of a steering guide (300), and an elongate member lumen (214) configured to insert the effector shaft (310) into the lumen (214) from outside the entrance of the tube. and a guide strand (218) for guiding the guide strand (218) into the lumen (214), the guide strand (218) being at least partially disposed within the lumen (214) and constrained at or toward the distal end (20) of the guide strand (218) to limit or prevent sliding of the guide strand (218) in a proximal direction relative to the lumen (214), wherein the placement tool (200) is configured to move and / or secure the target vessel (602) and body tissue (610) relative to an ionizing radiation therapy beam for an external beam radiation therapy treatment session.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to a wearable device that can move and fixate body tissue relative to an ionizing radiation therapy beam so that the position of the tissue is accurately replicated with each session of an external radiation therapy treatment program. [Background technology]

[0002] background Radiation therapy is the standard of care for many patients with various cancers around the pelvic region. Most of the tissue structures around the pelvic region, such as the bladder, rectum, cervix, uterus, and vagina, are not fixed to the pelvic wall and can move significantly from the day medical images of the treatment area are taken for treatment planning (treatment simulation) to the day the first external radiation therapy treatment is administered and, optionally, for subsequent days that form the duration of the entire radiation therapy program. When these structures move, the ionizing radiation no longer matches the tumor target, making external radiation therapy less effective.

[0003] External beam radiation therapy is often delivered in fractions. This means that lower radiation doses are delivered at frequent intervals (e.g., daily) to allow time for surrounding tissues to heal. Fractionated treatments can last 6–7 weeks, and pelvic organ movement during this period is unpredictable. Our own research has shown that the cervix can move up to 2.2 cm in each direction, which requires the introduction of a large volume margin around the original treatment zone (i.e., cervical cancer), increasing the treatment volume and increasing the incidence of acute and late side effects. Cervical movement between treatment and fractions, or between fractions, can be caused by the filling or emptying of the bladder and rectum, and in part by respiratory movements and intestinal peristalsis. Therefore, patients are asked to empty their rectum and fill their bladder before each fraction. This can reduce uterine displacement but does not reproducibly prevent it. In fact, patients are often unable to keep their bladders filled to the same degree for the entire treatment period (e.g., 28–30 fractions) because bladder inflammation prevents complete filling toward the end of radiation therapy. Furthermore, rectal emptying causes both the anterior and posterior rectal walls to converge inside the high-dose isodose volume surrounding the cervix with a treatment margin of 16–22 mm, so that the entire rectum is contained within the high-isodose volume.

[0004] In recent years, treatment techniques using conformal radiation therapy (multileaf collimator, 360° radiation therapy, CyberKnife, Tomotherapy) have made it possible to deliver very high doses locally to the tumor while sparing surrounding healthy organs with great precision. These techniques offer the greatest benefit when target motion is minimized. Nevertheless, they have not overcome the problem of tissue structure migration from simulation to treatment and / or between fractionated treatment sessions.

[0005] U.S. Patent Application Publication No. 2017 / 312546 A1 describes a fixation system for the rectal cavity that monitors the dose from an ionizing radiation source to a target area, such as the prostate, but the fixation system is not suitable for wear by the subject for the duration of a treatment program (6-7 weeks) or for reproducibility. U.S. Patent Application Publication No. 2008 / 293994 A1 describes a brachytherapy applicator and method, but this device and method is directed to a different field of radiation therapy treatment, namely brachytherapy, in which the radiation source is placed inside the body rather than externally. U.S. Patent Application Publication No. 2008 / 097471 A1 describes systems, methods, apparatus, and devices for performing improved gynecological and urological procedures, particularly those that allow for simultaneous tissue cutting and removal from a target site. This is unrelated to external radiation therapy. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, there is a need to create a system that can repeatedly fixate tissue structures in the pelvic region to benefit from high treatment precision. [Means for solving the problem]

[0007] overview 1. A positioning tool (200) for assisting in the treatment of a subject in an external radiation therapy program including one or more external radiation therapy treatment sessions, comprising: - an inserter (204) having a proximal end (40) and a distal end (20), the inserter comprising: - an elongate member (210) configured to be inserted through an inlet into a tube (602) connected to a body tissue (610) of a target, the elongate member (210) being provided with an elongate member lumen (214) configured to receive an effector shaft (310) of a steering guide (300); - a guide strand (218) for guiding the effector shaft (310) from outside the inlet of the tube into the lumen (214), the guide strand (218) being at least partially disposed within the lumen (214) and constrained at or toward the distal end (20) of the guide strand (218) to limit or prevent sliding of the guide strand (218) in a proximal direction relative to the lumen (214); The placement tool also - a removable steering guide (300) having a proximal end (40) and a distal end (20), the steering guide comprising: an effector shaft (310) disposed at the distal end (20) and configured for repeated, removable insertion into the elongate member lumen (214) along the guide strand (218); a handle portion (316) disposed at the proximal end (40) in fixed relationship to the effector shaft (310) for controlling the position and / or orientation of the effector shaft (310); the effector shaft (310) comprises a body having a guide strand passage (312) for slidable movement along the guide strand (218), the guide strand passage (312) extending at least partially along the length of the body; A placement tool (200) is provided that is configured to move and / or fixate a vessel (602) and body tissue (610) of interest for an external radiation therapy treatment session.

[0008] 1. A positioning tool (200) for assisting in the treatment of a subject in an external radiation therapy program including one or more external radiation therapy treatment sessions, comprising: - an inserter (204) having a proximal end (40) and a distal end (20), the inserter comprising: - an elongate member (210) configured to be inserted through an inlet into a tube (602) connected to a body tissue (610) of a target, the elongate member (210) being provided with an elongate member lumen (214) configured to receive an effector shaft (310) of a steering guide (300); - a guide strand (218) for guiding the effector shaft (310) from outside the inlet of the tube into the lumen (214), the guide strand (218) being at least partially disposed within the lumen (214) and constrained at or toward the distal end (20) of the guide strand (218) to limit or prevent sliding of the guide strand (218) in a proximal direction relative to the lumen (214); A positioning tool (200) is provided that is configured to move and / or fixate a vessel (602) and body tissue (610) of interest relative to an ionizing radiation therapy beam for an external beam radiation therapy treatment session.

[0009] The canal may be the cervix and / or uterus and / or vaginal vault of a subject, the body tissue may be tissue contained in the pelvic region, and the entrance to the canal may be an entrance to the canal within the cervix or vaginal vault.

[0010] The elongate member (210) may be provided with at least one sliding limiter (220) configured to reduce or prevent sliding of the elongate member (210) relative to the tube.

[0011] At least one sliding limiter (220) is an inflatable balloon assembly (230), which may comprise one or more inflatable balloons (231, -a to -h), or an expandable stent (240), a distal protrusion (245), or a stop member (250).

[0012] The inflatable balloon assembly (230) may include one or more inflatable balloons (231, -a-h), each having an inflatable balloon lumen (232) fluidly connected to an inflation lumen (234) extending proximally (40) via an inflation tube (236). The guide strand (218) may be the inflation tube (236).

[0013] The placement tool (200) includes at least two sliding limiters (220); - a first sliding limiter provided at the proximal end (40) of the elongate member (210) and comprising a stop member (250) configured to abut the inlet of the vessel, optionally the stop member (250) being provided with one or more suture channels (252) for suturing the inlet of the vessel; a second sliding limiter including: an inflatable balloon assembly (230), or - a distal projection (245), or an expandable stent (240), It is provided at the distal end (20) of the elongate member (210).

[0014] The guide strands (218) may be permanently or removably attached to the lumen (214).

[0015] The guide strand (218) may be a loose tube (237) configured to receive a stiffening stylet.

[0016] At least a portion of the inserter (204), or one or more imaging markers carried thereby, may be visualized by medical imaging, in particular X-ray medical imaging and / or MR medical imaging. and / or at least a part of the elongate member (210), or one or more imaging markers carried by it, can be visualized by medical imaging, in particular X-ray medical imaging and / or MR medical imaging; and / or - the inserter (204) or the elongate member (210) may be equipped with one or more wireless transponders, which determine the position and / or orientation of the inserter (204) and / or the elongate member (210) in real time by means of a spatial transponder detector, or The elongated member (210) may not be visible in an X-ray image.

[0017] The placement tool (200) may further include a removable steering guide (300) having a proximal end (40) and a distal end (20).

[0018] an effector shaft (310) disposed at the distal end (20) and configured for repeated, removable insertion into the elongate member lumen (214) along the guide strand (218); a handle portion (316) disposed at the proximal end (40) in fixed relationship to the effector shaft (310) for controlling the position and / or orientation of the effector shaft (310).

[0019] The effector shaft (310) can include a body having a guide strand passage (312) for slidable movement along the guide strand (218), the guide strand passage (312) extending at least partially along the length of the body. The guide strand passage (312) can be a groove or lumen in the body effector shaft (310).

[0020] The effector shaft (310) body may be rigid and the elongate member (210) may be flexible and may be stiffened by insertion of the effector shaft (310) into the elongate member lumen (214).

[0021] The handle portion (316) may be configured to be attached to a positioning device configured to adjust and fix the position and / or orientation of the effector shaft (310); Optionally, here The handle portion (316) is provided with a grip locator (330) configured to cooperate with an end effector attachment of a placement device for removable, repeatable, and reproducible attachment of the handle portion (316) to the placement device.

[0022] The removable steering guide (300) also - a transmission (314) connecting the handle portion (316) to the effector shaft (310); - optionally an inflatable transmission balloon (322) provided towards the distal end (20) of the transmission (314); - optionally, the inflatable transmission balloon (322) has a fixed maximum inflated diameter; and / or Optionally, the inflatable transmission balloon (322) carries one or more imaging markers that are visible by medical imaging, and / or Optionally, the inflatable transmission balloon (322) carries one or more wireless transponders for determining the position and / or orientation of the transmission (314) and / or effector shaft (310) in real time by a spatial transponder detector.

[0023] at least a portion of the effector shaft (310) and / or one or more imaging markers carried by the effector shaft (310) are visible by medical imaging, in particular X-ray medical imaging and / or magnetic resonance (MR) medical imaging; and / or - one or more imaging markers carried by at least the distal portion of the transmission (314) and / or the effector shaft (310) are visible by medical imaging, in particular X-ray medical imaging or MR medical imaging; and / or The transmission (314) and / or the effector shaft (310) are arranged with one or more radio transponders for determining the position and / or orientation of the transmission (314) and / or the effector shaft (310) in real time by means of a spatial transponder detector.

[0024] The handle portion (316) of the steering guide (300) may be positioned with a docking beacon (340) configured to provide real-time information regarding the position and optionally the orientation of the steering guide (300), allowing manual, semi-automatic, or automatic docking guidance between the positioning device and the handle portion (316).

[0025] Movement of the tube (602) by the placement tool (200) - during an external radiation therapy treatment session, the body tissue (608) connected to the tube (602) can be exposed to an ionizing radiation beam emitted by the ionizing radiation treatment head (518); Also During an external radiation therapy treatment session, the body tissue (608) connected to the tube (602) can be moved away from the ionizing radiation beam emitted by the ionizing radiation treatment head (518).

[0026] moreover, - a placement tool (200) as described herein; a placement device for adjusting and fixing the position and / or orientation of the handle portion (316) and the effector shaft (310) of the placement tool (200); - the handle portion (316) is configured to be removably attached to the placement device; - A system is provided, wherein the placement device is a robotic arm. [Brief explanation of the drawings]

[0027] [Figure 1] 1 shows an isometric view of an inserter provided herein. [Figure 2A] 1 shows a longitudinal cross-sectional view of an inserter provided herein positioned with a guide strand for removably attaching to a steering guide. [Figure 2B] FIG. 1 shows a longitudinal cross-sectional view of an inserter provided herein arranged with a removable (removable) guide strand with a ball stop, the inserter being provided for removably attaching to a steering guide. [Figure 2C] FIG. 1 shows a longitudinal cross-sectional view of an inserter provided herein arranged with a detachable (removable) guide strand having a threaded distal end, the inserter being adapted to be removably attached to a steering guide. [Figure 2D] 2D shows the detachable (removable) guide strand of FIG. 2C having a threaded distal end. [Figure 3] The different elements of the combinable inserter are shown, including the elongated member (A-D), the proximal sliding limiter (a-b) or none (c), and the distal sliding limiter (i-v); the guide strand is the flexible cord, the elongated member (G-J), and the proximal sliding limiter (g-j); the guide strand is the inflation tube, the elongated member (K-L), the proximal sliding limiter (k-l) or none (m), and the distal sliding limiter (xi-xv); the guide strand is removably attached to the elongated member, the elongated member (M-O), the proximal sliding limiter (n-o) or none (p), and the distal sliding limiter (xvi-xx); and the guide strand is the relaxation tube. [Figure 4] A close-up view of the inflation tube (236) within the inflation lumen (234) is shown. [Figure 5] 1 shows a placement tool (200) as described herein with an inserter (200) and a steering guide (300), with the inserter in the cervical canal. [Figure 6] 10 illustrates an example steering guide provided herein with an alternative arrangement of guide strand passage outlets. [Figure 6A] The angle gamma as seen along line (e) of FIG. 6 is shown. [Figure 7]Each shows a steering guide configuration with an integrated polymer steering wheel and transmission, each having a different configuration of the steering guide guide strand passageway exit. [Figure 8] Each shows a steering guide configuration with an integrated polymer steering wheel and transmission, each having a different configuration of the steering guide guide strand passageway exit. [Figure 9] 1 shows a steering guide with an inflatable transmission balloon. [Figure 10] 10A shows a steering guide in which the guide strand passage is a slot, the entrance to which is shown in detail in FIG. 10A. [Figure 11] 10 shows an alternative configuration of the notch in the handle portion (316) of the steering guide. [Figure 12] 10 shows an alternative configuration of the notch in the handle portion (316) of the steering guide. [Figure 13] 10 shows an alternative configuration of the notch in the handle portion (316) of the steering guide. [Figure 14] 10 shows an alternative configuration of the notch in the handle portion (316) of the steering guide. [Figure 15A] 1 shows a steering guide configuration with an integrated polymer handle and transmission, with a handle portion (316) including notches and corners. [Figure 15B] 1 shows a steering guide configuration with an integrated polymer handle and transmission, with a handle portion (316) including notches and corners. [Figure 15C] 1 shows a steering guide configuration with an integrated polymer handle and transmission, with a handle portion (316) including notches and corners. [Figure 16] This shows the same steering guide configuration as in Figure 15, with the addition of a transmission balloon. [Figure 17] FIG. 17 is a vertical cross-sectional view of the steering guide of FIG. 16. [Figure 18] 18 shows an enlarged view of the lumen of FIG. 17. [Figure 19] 1 shows a steering guide with different docking beacons. [Figure 20] 1 shows a steering guide with different docking beacons. [Figure 21] 1 shows a steering guide with different docking beacons. [Figure 22] 1 shows different inserters positioned within the cervical canal. [Figure 23] 1 shows different inserters positioned within the cervical canal. [Figure 24] 1 shows different inserters positioned within the cervical canal. [Figure 25] 1 shows different inserters positioned within the cervical canal. [Figure 26] 10 illustrates a placement tool comprising an inserter as provided herein positioned within the cervical canal and mounted on a steering guide, and movement of the steering guide to change the position of the cervix and uterus. [Figure 27] 1A and 1B are diagrams of a placement tool inserted into a canal, where different positions of the placement tool (A and B) change the position of the body tissue. [Figure 28] 1A and 1B are diagrams of a placement tool inserted into a canal, where different positions of the placement tool (A and B) change the position of the body tissue. [Figure 29A] 10A and 10B show composite medical images showing modified inserter postures recorded during the simulation and treatment session and before the start of exposure, respectively. [Figure 29B] 29A and 29B show composite medical images showing modified inserter postures recorded during the simulation and treatment session and before the start of exposure, respectively: Fig. 29A is a side view of the inserter; Fig. 29B is an axial view of the inserter. [Figure 30] Dose-volume graphs showing the dose / volume distribution received by the rectum, bladder, and cervical structures when the cervix is ​​not immobilized (a, b, c, respectively) or when the cervix is ​​immobilized (a', b', c'). DETAILED DESCRIPTION OF THE INVENTION

[0028] Detailed Description Before describing the tools and methods of the present invention, it is to be understood that the invention is not limited to the particular systems and methods or combinations described, as such tools and methods and combinations may, of course, vary. It is also to be understood that the terminology used herein is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0029] As used herein, the singular forms "a," "an," and "the" include both singular and plural referents unless the context clearly dictates otherwise.

[0030] As used herein, the terms "comprises," "including," and "consisting of" are synonymous with "includes," "including," or "comprises," and are inclusive or open-ended and do not exclude additional, unrecited members, elements, or method steps. As used herein, the terms "comprises," "including," and "consisting of" will be understood to include the terms "consisting of," "consisting of," and "consisting of."

[0031] The recitation of numerical ranges by endpoints includes not only the recited endpoints but also all numbers and fractions subsumed within the respective ranges.

[0032] The terms "about" or "approximately," when used herein in reference to a measurable value such as a parameter, amount, duration, etc., are meant to encompass variations of no more than ±10%, preferably no more than + / -5%, more preferably no more than + / -1%, and even more preferably no more than + / -0.1% from the specified value, to the extent that such variations are appropriate for practice in the disclosed invention. It should be understood that the value to which the "about" or "approximately" modifier refers is itself also specifically and preferably disclosed.

[0033] While the term "one or more" or "at least one," such as one or more or at least one member of a group of members, is clear in itself, by way of further illustration, this term specifically encompasses reference to any one of said members, or any two or more of said members, for example, any ≧3, ≧4, ≧5, ≧6, ≧7, etc. of said members, and up to all of said members.

[0034] All references cited herein are incorporated by reference in their entirety. In particular, the teachings of all references specifically referenced herein are incorporated by reference.

[0035] Unless otherwise defined, all terms used in disclosing the present invention, including technical and scientific terms, have the meanings commonly understood by one of ordinary skill in the art to which this invention belongs. As a further guide, terminology definitions are included to better understand the teachings of the present invention.

[0036] In the following text, various aspects of the invention are defined in more detail. Each aspect so defined can be combined with any other aspect, unless expressly indicated to the contrary. In particular, any feature indicated as being preferred or advantageous can be combined with any other feature indicated as being preferred or advantageous.

[0037] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrase "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment, although they may. Furthermore, as will be apparent to those skilled in the art from this disclosure, particular features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. Furthermore, although some embodiments described herein include some features but not other features included in other embodiments, it will be understood by those skilled in the art that combinations of features from different embodiments are within the scope of the present invention and are meant to form different embodiments. For example, in the appended claims, any of the claimed embodiments may be used in any combination.

[0038] In this description, references are made to the accompanying drawings that form a part hereof, which are shown solely for the purpose of illustrating specific embodiments in which the invention may be practiced. Any reference numbers in parentheses or boldface attached to elements are merely for illustrative purposes and are not intended to be limiting of the elements. It is to be understood that other embodiments may be utilized or structural or logical changes may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

[0039] The terms "distal," or "distal side," or "distal to," and "proximal," or "proximal to," are used throughout the specification and are generally understood in the art to mean toward (proximal) or away (distal) from the practitioner side of a device. Thus, "proximal" means toward the practitioner's side, and thus away from the subject's side. Conversely, "distal" means toward the subject's side, and thus away from the practitioner's side.

[0040] The term "longitudinal" is generally understood in the art to mean along the longer length of a treatment or simulation table. It may be used to refer to the radiation therapy treatment or simulation table itself, a device that can be attached to the radiation therapy treatment or simulation table, or a subject lying on the radiation therapy or simulation table.

[0041] The term "lateral" is generally understood in the art to mean along the shorter length of the treatment or simulation table, i.e., side to side or left to right. It may be used to refer to the radiation therapy treatment or simulation table itself, a device that can be attached to the radiation therapy treatment or simulation table, or a subject lying on the radiation therapy or simulation table.

[0042] The term "superior" is understood to mean toward the subject's head. It may be used to refer to a radiation therapy treatment table or simulation table, or a device attachable to a radiation therapy treatment table or simulation table, or a subject lying on the radiation therapy treatment table or simulation table. The term "inferior" is understood to mean toward the subject's feet. It may be used to refer to a radiation therapy treatment table or simulation table, or a device attachable to a radiation therapy treatment table or simulation table, or a subject lying on the radiation therapy treatment table or simulation table.

[0043] Provided herein is a placement tool for assisting in the treatment of a subject for an external radiation therapy program. The external radiation therapy program includes a simulation of at least one session or portion of an external radiation therapy treatment and / or treatment. The placement tool (200) includes an inserter (204) (e.g., FIGS. 1, 2A-2D) having a proximal end (40) and a distal end (20). The inserter (204) includes an elongate member (210) configured for insertion through an entrance into a vessel connected to bodily tissue. The elongate member (210) may be dimensioned to engage a wall of the vessel such that movement of the placement tool (200) causes movement of the vessel. The elongate member (210) is provided with an elongate member lumen (214) configured to receive an effector shaft (310) of a steering guide (300) (e.g., FIG. 6). The effector shaft (310) may be configured to cooperate with the elongate member (210) such that movement of the steering guide is transmitted to the elongate member (210). The effector shaft (310) may be further configured to stiffen at least a substantial portion of the elongate member (210) when the elongate member (210) is flexible. The elongate member lumen (214) of the inserter (204) may be configured for repeated, removable attachment to the effector shaft (310) of the steering guide (300). The inserter (204) further includes a guide strand (218) for guiding the effector shaft (310) into the lumen (214) from outside the inlet of the tube. A distal end (20) of the guide strand (218) is attached in a fixed relationship to the lumen (214).

[0044] Movement of the tube by the positioning tool (200) causes movement of the target body tissue with respect to the external ionizing radiation therapy beam, particularly with respect to the beam intersection volume of the external ionizing radiation therapy beam. The position and / or orientation (attitude) of the positioning tool can be adjustable and fixed during at least a portion of a treatment session. The fixed attitude of the positioning tool stably fixes the position of the body tissue with respect to the ionizing radiation therapy beam. FIGS. 27 and 28 illustrate the present invention. Movement of the tube by the positioning tool (200) can align the target body tissue with the ionizing radiation therapy beam, for example, with an ionizing radiation therapy isodose volume defined during patient simulation under CT scan or MR. Alternatively, movement of the tube by the positioning tool (200) can move and / or fix the target body tissue away from the ionizing radiation therapy beam, for example, to protect the structure.

[0045] Panel A of Figure 27 shows a placement tool (200) inserted into a target vessel (602) and body tissue (608) connected to the vessel (602). By adjusting the orientation of the placement tool (200) (Panel B), the position of the body tissue (608) can be stabilized, adjusted, and fixed relative to the ionizing radiation beam emitted by the ionizing radiation head, particularly relative to the beam intersection volume (612) (e.g., isocenter). The beam intersection volume (612) has a fixed position in Panels A and B. In the case of Panel B of Figure 27, the body tissue (608) is also a treatment target (610) that is brought into the beam intersection volume (612) for exposure to ionizing radiation. The orientation of the placement tool (200) can be recorded and reapplied in subsequent sessions of fractionated treatment.

[0046] Panel A of Figure 28 shows the placement tool (200) inserted into the target vessel (602) and the body tissue (608) connected to the vessel (602). By adjusting the orientation of the placement tool (200) (Figure 28, panel B), the position of the body tissue (608) can be stabilized, adjusted, and fixed relative to the ionizing radiation beam emitted by the ionizing radiation head, particularly relative to the beam intersection volume (612) (e.g., isocenter). The beam intersection volume (612) has a fixed position in panels A and B. In the case of panel B of Figure 28, the body tissue (608) is not the treatment target (610) and is brought outside the beam intersection volume (612) to avoid exposure to ionizing radiation. The orientation of the placement tool (200) can be recorded and reapplied in subsequent sessions of fractionated treatment.

[0047] The extent of movement of a target organ or tissue between simulation and treatment, or between treatment sessions, is shown in Figures 29A-29B. Each figure is a fused x-ray image of a subject undergoing simulation and treatment of a cervical tumor, with the currently described placement tool (200) inserter (204) inserted into the cervical canal, with images taken during the simulation and the subsequent first treatment session superimposed. The outer margin (614) of the irradiated volume is shown.

[0048] The first position (A) of the placement tool (200) inserter (204) adopted in the simulation corresponded to the natural positioning of the tissue and organs, with minimal active position adjustments by the robotic arm. A second position (B) of the placement tool (200) inserter (204) was recorded during the first subsequent treatment session, prior to any adjustments by the robotic arm. There is a significant difference between the first position (A) and the second position (B). This is due to internal tissue and organ motion between sessions, which displaced the inserter (204) tip by approximately 2.1 cm and correspondingly shifted the location of the treatment target. The new position (B) was at the outer margin of the irradiated volume and received a much lower dose than calculated. The internal motion was corrected by the present system and method by adjusting the position of the placement tool (200) inserter (204) by the robotic arm during the treatment session to correspond to the position recorded during the simulation, leading to a significant reduction in toxicity.

[0049] The effect of the positioning tool on reducing toxicity in adjacent structures is shown in Figure 30, a dose-volume histogram chart showing the relationship between the percentage of irradiated volume for each organ (rectum, bladder, and cervix) and the dose received by said irradiated volumes in the rectum (a, a'), bladder (b, b'), and cervix (c, c'). This was calculated for external beam radiation therapy treatment of the cervix when the cervix was not positioned (in its natural position) (a, b, c) and when the cervix was positioned using the positioning tool (a', b', c'). When the cervix is ​​the treatment target, the rectum (a, a') and bladder (b, b') are affected by radiation toxicity. The margins used in this calculation were 16 mm when the cervix was not positioned (large margin) and 5 mm when the cervix was positioned using the positioning tool.

[0050] In the rectum (a, a'), if the cervix was not positioned using a positioning tool, 50% of the rectal volume was treated with 50 Gy (a 50 When the cervix was positioned using the positioning tool, 13% of the rectal volume received a dose of 50 Gy (a' 50If the cervix is ​​not in place, 30% of the rectal volume receives 70 Gy (a 70 When the cervix was positioned using the positioning tool, 2.5% of the rectal volume received a dose of 70 Gy (a' 70 Therefore, placing the placement tool over the cervix reduced the dose received by the rectum from 50% to 13% (a 3.9-fold reduction) at 50 Gy and from 30% to 2.5% (a 12-fold reduction) at 70 Gy.

[0051] In the bladder (b, b'), when the cervix is ​​not in place, 22% of the bladder volume is treated with 50 Gy (b 50 ) dose. When the cervix was positioned using the positioning tool, 10% of the bladder volume received 50 Gy (b' 50 ) dose. If the cervix is ​​not positioned, 12% of the bladder volume receives 70 Gy (b 70 When the cervix was positioned using the positioning tool, 3% of the bladder volume received a dose of 70 Gy (b' 70 Therefore, placing the placement tool over the cervix reduced the dose received by the bladder from 22% to 10% (a 2.2-fold difference) at 50 Gy and from 12% to 3% (a 4-fold reduction) at 70 Gy.

[0052] For the cervix (c, c'), if the cervix is ​​not positioned, 50 Gy (c 50 When the cervix was positioned using the positioning tool, 100% of the cervical volume received a dose of 50 Gy (c' 50 ) dose. If the cervix is ​​not positioned, approximately 98% of the cervical volume receives 70 Gy (c 70 When the cervix was positioned using the positioning tool, approximately 99.5% of the cervical volume received a dose of 70 Gy (c' 70 ) dose. Thus, the placement tool did not affect cervical volume / dose, with a slight increase in cervical volume receiving the higher 70 Gy dose.

[0053] The results in Figure 30 demonstrate that high doses can be delivered externally to the cervix while reducing complications caused by irradiation of the rectum and bladder. Traditionally, such high doses have had to be delivered via brachytherapy (an internal radiation source), which targets more internal structures but is a more complex and uncomfortable procedure due to the complex intervention required. In fact, the majority of cervical cancer patients are inoperable due to vaginal or parametrial invasion, requiring anesthesia and hospitalization to implant the invasive structures using brachytherapy needles. This is feasible only at a limited number of radiation therapy centers, and therefore not all patients can receive this treatment. This complex brachytherapy intervention can be avoided by immobilizing and positioning the cervix using the present positioning tool (200). Immobilizing and positioning the cervix allows for a higher dose to the cervix without excessive toxicity to surrounding tissues, reducing the need for brachytherapy.

[0054] The canal (602) can be precisely moved and / or fixed by the positioning tool (200) to reposition and fix the canal and body tissue relative to the external ionizing radiation therapy beam. The body tissue may be within the canal or may be a structure that moves as the canal moves (e.g., the prostate gland moving with the rectal canal or the uterus moving with the cervical canal). The canal (602) of interest is preferably a natural body structure canal (passageway), such as the cervical canal (602') and / or a canal created within the uterus (604), vagina (606), or a vaginal vault mass (tumor or tumor recurrence). In Figures 22-26, the positioning tool (200) is positioned within the cervical canal (602'). The canal may also be a surgically formed canal within a tissue mass, such as the vaginal vault or breast.

[0055] The target body tissue (608) associated with the canal refers to the tissue that can be moved by changing the spatial position and / or orientation of the canal, i.e., by changing the spatial position and / or orientation (posture) of the placement tool (200). In other words, the canal is movably connected to the body tissue. The body tissue may be part of the wall of the canal or may be a different tissue structure whose position and / or orientation is affected by the movement of the canal. For example, the position and / or orientation of the bladder, vagina, uterus, and rectum can be changed by changing the spatial position and / or orientation (posture) of the inserter (204) or effector shaft (310) within the cervical canal.

[0056] The body tissue (608) may be a treatment target (610) (e.g., a tumor) and may be tissue introduced into the external ionizing radiation therapy beam for exposure to the beam. Thus, the treated target may be positioned very precisely, allowing for maximum dose acceptance and reduced damage to healthy structures. Alternatively, the body tissue may be tissue that is moved outside of the external ionizing radiation therapy beam, thereby avoiding exposure to the beam. Thus, healthy tissue may be moved away from the target, allowing for more isolated exposure.

[0057] The body tissue (608) may be tissue of a tissue or organ. The body tissue may be tissue structures in the pelvic region, such as the cervix, uterine body, rectum, bladder, vagina, etc., that can be moved by changing the position and / or orientation of the cervix and / or uterus and / or vagina. The body tissue may be tissue structures in the region surrounding the uterus and vagina, such as the rectum, lower colon, bladder, etc., that can be moved by changing the position and / or orientation of the uterus and vagina. It will be appreciated that the placement tool can be used to treat multiple tissues adjacent to a duct.

[0058] During simulation under medical imaging, the tube (602) can be precisely positioned or moved by the positioning tool (200) to align the body tissue with the external ionizing radiation therapy beam, particularly with respect to the position reference, and the position of the positioning tool (200) is recorded, which position will be used for subsequent treatment.

[0059] Radiation therapy is delivered to the subject while the tube is held in one or more treatment positions, which can be replicated for one or more subsequent sessions. This system allows body structures that may change shape or position between sessions to be brought into a known, well-defined position and stabilized during each session.

[0060] For example, if the cervix is ​​positioned in the same spatial position relative to the pelvic bone or the isocenter of the radiation therapy machine during each radiation treatment session, spontaneous cervical movement will be completely eliminated, the volume irradiated around the cervix to account for spontaneous cervical displacement will be significantly smaller, and the safety margin around the cervix may be reduced from 2 cm to 3–4 mm.

[0061] The systems, placement tools, and methods described herein can be used to treat one or more tumors present in body tissue.

[0062] Typically, the ionizing radiation head is moved during a treatment session so that different ionizing radiation beam directions intersect, thereby minimizing damage to surrounding tissue. A beam intersection volume is a volume where different ionizing radiation beam directions intersect during an external radiation therapy treatment session. A simulated beam intersection volume is a volume where various simulated ionizing radiation beam directions intersect during a simulation of an external radiation therapy treatment session. The (simulated) beam intersection volume typically coincides with a tissue target (e.g., a tumor) within a subject.

[0063] When the radiation therapy device (510) includes an ionizing radiation therapy head (518) that rotates around a single axis, the beam intersection volume is also known as an isocenter, which is the center of rotation of the ionizing radiation beam emitted by the ionizing radiation therapy head (518) during an external radiation therapy treatment session. Isocenters are well known in the art. See, for example, http: / / ozradonc.wikidot.com / isocentre-of-the-linac. Devices with isocenters (linacs) are manufactured, for example, by Varian. The simulated isocenter is the center of rotation of the ionizing radiation beam emitted by the ionizing radiation therapy head (518) during a simulated external radiation therapy treatment session.

[0064] In other systems (e.g., CyberKnife), the radiation therapy device (510) is provided with an ionizing radiation therapy head (518) mounted on a robotic arm having three or more degrees of freedom of movement, allowing for directional control of the ionizing radiation beam around multiple axes. The beam intersection volume is the volume intersected by different directions of the ionizing radiation beam emitted by the ionizing radiation therapy head (518) during an external radiation therapy treatment session. The simulated beam intersection volume is the volume intersected by different directions of the ionizing radiation beam emitted by the ionizing radiation therapy head (518) during a simulation of an external radiation therapy treatment session.

[0065] By external beam radiation therapy program, we mean one or more sessions of radiation therapy delivered to the target treatment area by an external beam radiation therapy source (e.g., a linear accelerator, optionally equipped with a multi-leaf collimator, or a tomotherapy system, or a moving ionizing radiation source such as a CyberKnife system). Treatment can consist of one or more sessions or fractions. With multiple fractions, the total dose is divided into several smaller doses (fractions) delivered at intervals over time. Treatment for cervical tumors typically lasts 28 to 32 fractions, with each fraction delivering a dose of up to 2.6 Gy to the tumor. Fractionation allows healthy tissue surrounding the treatment area time to recover. This system can also be used to deliver treatment in multiple fractions, either as boost therapy or as palliative therapy in the event of bleeding. Higher doses per fraction, such as five 6 Gy or five 4 Gy fractions, or five 7 Gy fractions, can be delivered to the tumor as palliative therapy.

[0066] A radiation therapy program typically consists of a simulation portion and a treatment portion. The simulation portion involves acquiring internal medical images of the subject (e.g., by CT, MRI), usually in three dimensions, while the subject is precisely aligned with an imaging device on a mobile treatment simulation table. These medical images are used to plan the subsequent external beam radiation treatment. From the images, the radiologist determines which tissue structures will receive high doses, low doses, sensitive structures, sessions or fractions, etc. The treatment portion exposes the subject to ionizing radiation.

[0067] The elongate member (210) of the inserter (204) has a proximal end (40) and a distal end (20). The elongate member (210) may be rigid (non-flexible). The elongate member (210) may be flexible, which allows for better body resistance to the elongate member (210) and allows it to remain in place within the canal for up to 2-3 months over the course of fractionated treatment.

[0068] The elongated member (210) is sized for insertion into a canal, particularly into the cervix and / or uterus and / or vaginal vault. The elongated member (210) may have a length of 1 to 10 cm. When the elongated member (210) is configured for placement within the cervix and / or uterus, it may have a length of 1 to 8 cm and a maximum outer diameter of 3 to 8 mm. When the elongated member (210) is configured for placement in the vaginal vault, it may have a length of 1 to 5 cm and a maximum outer diameter of 3 to 8 mm. The diameter of the elongated member (210) may be uniform or may vary from the proximal end to the distal end. For example, the diameter may be larger toward the proximal portion and smaller toward the distal portion. The change in diameter may be gradual. The change in diameter may be gradual over the length of the elongated member (210). A smaller distal diameter provides a more atraumatic entry into the vagina, while a larger diameter toward the proximal portion provides increased stiffness to the elongate member (210). See Tables 2 and 2a for recommended dimensions for various medical applications.

[0069] The effector shaft (310) may be configured to cooperate with the elongate member (210) such that movement of the steering guide is transferred to the elongate member (210).

[0070] The elongate member (210) has an elongate member lumen (214) disposed therein. The elongate member lumen (214) is open at the proximal end (20) to allow for slidable insertion of the effector shaft (310) of the steering guide (300) prior to treatment. The elongate member lumen (214) may be open at or toward the distal end (20), or may be closed. If it is open, it may provide a drainage channel (270), an exit port (272), or a threaded passageway (272, -c) for a removable guide strand (218). The steering guide (300) attached to the inserter (204) or elongate member (210) is rigidly attached. The rigid attachment minimizes play or backlash between the inserter (204) and the handle portion (316) of the steering guide (300).

[0071] The distal tip of the elongate member (210) may be atraumatic (e.g., rounded, dome-shaped, non-incisional). The elongate member (210) may have a circular profile perpendicular to its longitudinal axis. The elongate member (210) may be essentially cylindrical. One or more fins may be disposed on the elongate member (210). Fins are protrusions extending outward from the surface of the elongate member (210). The fins also extend longitudinally. This serves to better secure the elongate member (210) to the inner wall of the canal (e.g., the cervix) and prevent the elongate member from rotating during manipulation with the steering guide. Preferably, the one or more fins are located within the proximal (40) half of the elongate member (210), e.g., within 2-4 cm of the proximal end (40).

[0072] The elongated member (210) may be a rigid tube. Alternatively, the elongated member (210) may be a flexible tube. The advantage of a flexible tube is that it is more comfortable for the subject to wear during the treatment period (e.g., several weeks). The wall of the elongated member (210) may be made from any biocompatible material, such as a polymer. Examples of suitable materials include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, polyurethane, or silicone. Examples of materials used to form the rigid elongated member (210) include polycarbonate, PEEK, carbon fiber, and fiber-reinforced polyacrylamide resin (e.g., Ixef (Solvay)). Examples of materials used to form the flexible elongated member (210) include polyamide, polyimide, polyurethane, or silicone.

[0073] Typically, treatment is first simulated under a CT scan, a PET-CT scan, or an MRI. Subsequent treatment may include one or more X-rays in the treatment room. The elongated member (210) is preferably made from a material compatible with medical imaging, such as CT or MRI. The material may or may not be visible on medical images. Examples of materials that are invisible on CT or CT / PET scans include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, polyurethane, or silicone. To enhance visibility on CT or PET / CT, a small percentage of barium sulfate may be mixed into the material. Examples of materials that are visible on MRI scans include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, polyurethane, or silicone. The pose (position and / or orientation) of the elongated member (210) may be determined directly from medical images of the elongated member (210) under MRI or barium sulfate opacified (CT or PET-CT). Examples of materials that are invisible in CT and CT / PET scans when not mixed with barium sulfate include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, and silicone. If invisible or not sufficiently visible to determine the position and / or orientation of the inserter, one or more imaging markers may be placed on the elongated member (210). This is useful when performing images using the linear accelerator's imaging tools.

[0074] The inserter (204), particularly the elongate member (210), may be provided with one or more imaging markers (206) that can be identified by medical imaging. In FIG. 1, a pair of imaging markers (206) are fixedly attached to the outer surface of the elongate member (210). The imaging markers (206) can be identified by medical imaging. The imaging markers (206) may be provided in a fixed relationship to the elongate member (210), for example, on the inner surface, outer surface, or within the body of the elongate member (210). The imaging markers (206) may be protrusions or depressions. They may be made of the same material as the elongate member (210) and be visible on medical imaging due to their different sizes. The imaging markers (206) may be made of a different material from the elongate member (210), for example, heavy metals such as platinum, platinum-iridium, tantalum, or tungsten, or low-density metals such as titanium or coated aluminum.

[0075] The inserter (204), and in particular the elongate member (210), may be provided with one or more (e.g., two, three, or more) position-determining radio transponders (260), the position of which may be determined and, optionally, tracked using a spatial transponder detector. The terms position-determining radio transponder and transponder are used interchangeably herein. A transponder is sometimes known as a beacon transponder. In FIG. 1, three transponders (260, a, b, c) are provided fixedly mounted at different positions on the outer surface of the elongate member (210).

[0076] The transponder (260) is a device that emits an electromagnetic pulse at a specific frequency detectable by a spatial transponder detector, typically consisting of multiple spatially separated receivers (coils). The timing of the pulses detected by the multiple spatially separated receivers in the position transponder reader allows the transponder's location to be accurately determined. The transponder (260) can receive power inductively. When multiple transponders are present, each transponder may emit a signal at a different frequency. If at least three separately identifiable transponders (260, a, b, c) are placed at different locations on the inserter (204), the orientation of the inserter (204) can also be determined. Examples of such systems are described, for example, in U.S. Patent Nos. 9,248,003 B2 and 9,072,895. The use of transponders reduces the need to align the inserter (204) before radiation therapy using medical imaging, thereby reducing exposure to imaging radiation.

[0077] According to one aspect: - at least a part of the inserter (204) or one or more imaging markers carried by the inserter (204) are made visible by medical imaging, in particular X-ray medical imaging and / or MR medical imaging, and / or - one or more imaging markers carried by at least a part of the elongate member (210) or by the inserter (204) are visible by medical imaging, in particular X-ray medical imaging and / or MR medical imaging, and / or - The inserter (204) and / or the elongated member (210) are arranged with one or more wireless transponders carried by the inserter (204) to determine the position and / or orientation of the inserter (204) and / or the elongated member (210) by means of a spatial transponder detector.

[0078] The guide strand (218) is at least partially disposed within the elongate member lumen (214) and exits therefrom at a proximal end. The effector shaft (310) of the steering guide (300) includes a guide strand passage (312) that receives the guide strand (218). The guide strand passage (312) may be a lumen within the effector shaft (310) or a longitudinal groove in the surface of the effector shaft (310). The guide strand (218) is constrained at or toward the distal end (20) of the guide strand (218), thereby limiting or preventing sliding of the guide strand (218) proximally relative to the lumen (214). This allows tension to be applied to the guide strand (218) in the proximal direction without releasing or displacing the guide strand (218). The guide strand passage of the effector shaft (310) can be threaded through the proximal end of the guide strand, which continues outside the body, and securely guided into the elongate member lumen (214). The guide strand allows for repeated attachment and detachment of the steering guide before and after simulation and / or radiation treatment. Access to the elongate member lumen (214) is possible even when the elongate member lumen (214) is located in situ, e.g., in the cervix.

[0079] The guide strand (218) may be a flexible cord (219) (e.g., comprised of another strand), an inflation tube (236), or a relaxation tube stiffened by a stiffening stylet. The outer diameter of the guide strand (218) is smaller than the inner diameter of the effector shaft (310). It is sized to be threaded through the guide strand passage (312). The guide strand (218) has a narrow cross-sectional profile, e.g., 0.1-2.5 mm (flexible cord), or 1-5 mm (inflation tube), or 1-5 mm (relaxation tube). It has tensile strength to resist tension applied during insertion of the effector shaft (310) of the steering guide (300) into the elongate member lumen (214). It may not be longitudinally expandable. Examples of guide strands (218) that are flexible cords (219) are shown in Figures 1, 2A, 2B, 2C, and 3, panels A, B, C, D, E, F, K, L, a, b, c, d, e, f, k, l, and m.

[0080] The guide strands (218) may be non-removably (e.g., permanently) attached to the inserter (204) or may be removably attached to the inserter (204). If the guide strands (218) are removably attached, preferably such guide strands are flexible cords (219).

[0081] Permanently attached to the introducer (204) may be achieved, for example, by knot attachment to the struts (213) with adhesive during molding production of the elongate member (210). The distal ends of the guide strands (218) are preferably attached in fixed relationship to the elongate member lumen (214), preferably at the distal-most ends of the elongate member lumen (214). Examples of non-removably attached guide strands (218) are shown in Figures 2A and 3, panels A, B, C, D, G, H, and I.

[0082] Removable attachment of guide strands (218, 219) to inserter (204) allows for both actions.

[0083] - reliable guidance of the effector shaft (310) into the elongate member lumen (214), if the guide strands (218, 219) are present;

[0084] - Insertion of a brachytherapy applicator into the elongate member lumen (214) when the guide strands (218, 219) are removed (disconnected).

[0085] There are situations in which treatment begins with an external beam radiation therapy program and then requires brachytherapy. Brachytherapy, well known in the art, is a process of treating a target using an internal ionizing radiation source. The radiation source is placed in a sealed capsule at the end of a flexible cable wrapped around an afterloader storage. If necessary, a pushable cable is routed from the afterloader to a transport tube connected to a brachytherapy applicator at the target. The radiation source is held in place by or within the brachytherapy applicator for the duration of treatment and then retrieved into the afterloader storage. The elongated member (210) can be utilized as a catheter to allow for the introduction of a brachytherapy applicator in the field. When the elongated member (210) is already positioned adjacent to the target, the guide strand (218) is detached and removed, and the applicator is introduced and maintained within the elongated member lumen (214) to irradiate the target.

[0086] If the guide strand (218, 219) is removably attached to the introducer (204), it is typically a flexible cord (219).

[0087] According to one example, the removable guide strands (218, 219) are flexible cords (219) having fixed ends (219, b) provided with stop anchors (219, c).

[0088] The elongate member lumen (214) may have exit ports (272,-a, -b) at its distal end (204). The guide strands (218, 219) are positioned through the proximal entrance (214,-a) into the elongate member lumen (214), distally along the elongate member lumen (214), through the distal exit ports (272,-a, -b), and proximally back to the proximal end of the inserter (204). The guide strands (218, 219) have a fixed end (219,b) and a free end (219,a). The fixed end (219,b) exits through the exit ports (272,-a, -b). The fixed end (219,b) is provided with a stop anchor (219,c). The stop anchor (219,c) is configured to engage with a reciprocating stop (254) on the inserter (204), for example, the elongate member (210) or the stop member (250). The reciprocating stop (254) may be a passageway. The reciprocating stop (254) is located at a proximal end of the inserter (204) that is accessible to a professional when the inserter (204) is in situ. The free end (219,a) exits the elongate member lumen (214) through the proximal inlet (214,a). The free end (219,a) can pass unrestricted through the proximal inlet (214,a) into the elongate member lumen (214), through the outlet ports (272,a,b), and to the reciprocating stop (254).

[0089] Tension applied to the free end (219, a) of the guide strand (218) engages the stop anchor (219, c) with the shuttle stop (254), preventing sliding movement of the guide strand (219) within the elongate member lumen (214). Tension applied to the fixed end (219, b) of the guide strand (218) causes the guide strand (218) to slide within the elongate member lumen (214), with the free end (219, a) passing through the elongate member lumen (214), exit ports (270, a, b, c), and the proximal entrance to the shuttle stop (254), ultimately removing the guide strand (218) from the introducer (204). An example of a removable guide strand (218) with a stop anchor (219, c) is shown in Figure 2B and panels E, F, d, e, and f of Figure 3.

[0090] According to another example, the removable guide strands (218, 219) are flexible cords (219) having threaded distal ends (219, d). The distal end (20) of the elongate member lumen (214) may be provided with a reciprocating threaded passage (272, -c). Axial rotation of the flexible cord (219) in one direction allows the threaded distal ends (219, d) of the guide strands (218, 219) to engage with the reciprocating threaded passage (272, -c) of the inserter (204), thereby attaching the elongate member (210). Rotation in the other direction releases the flexible cord (219) from the elongate member (210). An example of a guide strand (218) with a removable threaded portion (219, d) is shown in Figures 2D, 2E, and panel K of Figure 3.

[0091] According to another example, the detachable guide strands (218, 219) are flexible cords (219) that are detachable by applying a pulling force above a certain threshold. The pulling force may be in the range of 1 kg to 3 kg. In one example, the flexible cord (219) has a breakable portion (219, e) at the distal end that attaches to the inserter (204), specifically the elongate member (210). In another example, the flexible cord (219) is attached to the inserter (204) by a bond that pulls it away from the inserter (204). An example of a guide strand (218) with a breakable portion (219, e) is shown in panel L of Figure 3.

[0092] The guide strands (218), which are flexible cords (219), can be made of any suitable material, preferably a non-ferromagnetic material such as nylon, other polymeric materials, or metals such as nitinol. The guide strands (218), which are inflation tubes, can be made of any suitable material, preferably a non-ferromagnetic material such as a polymer such as polyamide, or a metal such as nitinol. The guide strands (218), which are relaxation tubes, can be made of any suitable material, preferably a non-ferromagnetic material such as a polymer such as polyamide. The guide strands (218) may contain or be coated with an antibacterial agent. Examples of antibacterial agents include silver particles, erythromycin, or other antibiotics. Preferably, the guide strands (218) are made of a radiolucent material. Preferably, the guide strands (218) are made of an MRI-compatible and biocompatible material. The distal ends of the guide strands are preferably attached in fixed relationship to the elongate member lumen (214), preferably at the distal-most ends of the elongate member lumen (214).

[0093] The guide strand (218) may be an inflation tube (236), a tube having a lumen fluidly connecting with the distal sliding limiter (220), which is the expandable balloon assembly (230) (see below). The lumen of the inflation tube (236) may allow the passage of a fluid (e.g., liquid, saline) for inflating one or more balloons of the expandable balloon assembly (230). Examples of the guide strand (218) that is an inflation tube (236) are shown in panels G, H, J, h, i, and j of Figure 3, Figure 4, and Figures 24-26. The elongate member (200) may be provided with a crimpable or self-expandable cylindrical body (e.g., a metal mesh) (240) around the exterior of its distal end. This allows a physician to open the metal mesh within a vessel (e.g., inside the uterus (604)) by inflating a balloon (a balloon-expandable mesh) or removing a sliding member (a self-expanding stent) around the mesh. The inflatable balloon assembly (230) allows for the elongate member to resist movement within the uterus. The stitches used to attach the inserter to the cervical introitus may loosen over time as the tumor shrinks. The presence of the distal sliding limiter (220), which is the inflatable balloon assembly (230), prevents the elongate member (210) from sliding downward out of the uterus (604).

[0094] The guide strand (218) may be a relaxation tube (237), which is a tube having a lumen (238) configured to receive a stiffening stylet. The relaxation tube (237) is more flexible without the stiffening stylet and becomes less flexible (stiffer and easier to push) when a stiffening stylet is inserted into the lumen (238). Examples of guide strands (218) that are relaxation tubes (237) are shown in panels M, N, O, P, n, o, p, and xvi to xx of Figure 3. The stiffening stylet is more flexible than the relaxation tube (237). The stiffening stylet may be a metal or polymer wire. The stiffening stylet is not present in the relaxation tube lumen (238) while the introducer (204) is worn by the subject. The relaxation tube (237) without the stiffening stylet provides increased flexibility and better adapts to changes in the subject's shape during insertion, allowing for a more comfortable insertion of the inserter. A stiffening stylet is inserted along the lumen (238) of the relaxation tube (237) before inserting the steering guide. This increases stiffness and allows the guide strand passage (312) of the steering guide's (300) effector shaft (310) to be pushed along the stiffened relaxation tube (237) with reduced buckling, resulting in a faster and less uncomfortable experience for the subject. After simulation of external radiation therapy treatment and / or treatment with a specific position of the inserter (204), the steering guide (300) is removed. The stiffening stylet may be removed after the steering guide (300) is inserted or after the steering guide (300) is removed.

[0095] If the inserter (204) is intended for the cervix (602), the guide strands (218) are long enough to exit through the vagina (606). The trailing ends of the guide strands (218) can be secured with adhesive pads to the subject's skin in the groin, for example, during simulation and radiation therapy treatment and / or between radiation therapy treatment fractions.

[0096] The inserter (204) may include one or more sliding limiters (220). The elongate member (210) may be provided with one or more sliding limiters (220) configured to reduce or prevent sliding of the elongate member (210) relative to the vessel, as shown, for example, in Figures 1, 2A, 2B, 3, 5, and 23-26. The sliding limiter (220) may engage the vessel wall, for example, by friction, or abut against the vessel inlet or outlet. The sliding limiter (220) may be attached in a fixed relationship to the elongate member (210). The sliding limiter (220) may be positioned at a distinct longitudinal position on the elongate member (210). Examples of sliding limiters include an inflatable balloon assembly (230), an expandable stent (240), and a stop member (250).

[0097] There are two sliding limiters (220), each of which may be positioned at a different longitudinal position on the elongate member (210). One sliding limiter (220) may be positioned at the proximal end (40) of the elongate member (210), and the other may be positioned at the distal end (20) of the elongate member (210). One sliding limiter (220) may be a stop member (250), and the other sliding limiter may be an inflatable balloon assembly (230) or an expandable stent (240). This arrangement allows the two sliding limiters (220) to be positioned on the sides of tissue located between the inlet and outlet of the tube, effectively clamping the elongate member (210) against it. Two sliding limiters (220) are positioned at opposite ends of the elongate member (210) in Figure 3 (see combinations of Tables 1a-e) and Figures 24-26. Preferably, one of the two sliding limiters (220) is the proximal stop member (250). The placement of the two sliding limiters (220) can contribute to improved accuracy of uterine placement by reducing the degrees of freedom of the elongated member (210) within the uterine canal (604). Furthermore, this solves a problem observed when the proximal stop member (250) is sutured to the cervix. After multiple divisions, the cervical tumor begins to shrink, loosening the sutures and potentially causing the elongated member to become dislodged. This can be important when the effector shaft (310) is withdrawn after division. By inflating a distally positioned balloon assembly (230) or expandable stent (240), the elongated member (210) is secured within the uterine canal (604) and can withstand tension, for example, during withdrawal of the effector shaft (310).

[0098] The sliding limiter (220) may be an inflatable balloon assembly (230). The inflatable balloon assembly (230) may include one or more (e.g., two, three, four) inflatable balloons (231,-a-h) disposed around at least the distal portion (20) of the elongate member (210), as illustrated in Figure 3 (panels i, ii, iii, vi, vii, viii, xi, xii, xiii, xvi, xvii, xviii, G, H, J), Figures 24, 25, and 26. Two inflatable balloons (231,-a, 231,-b) may be disposed at the distal end of the elongate member (210) and may optionally be diametrically spaced (e.g., Figure 3 (panels i, vi, xi, xvii, G), Figures 24, 25, and 26). An inflatable balloon can be provided at the distal end of the elongate member (210) and can optionally have an annular, e.g., conical (Figure 3, panels ii, vii, xii, xvii, 231-c) or barrel shape (Figure 3, panels iii, viii, xiii, xviii, 231-d; Figure 3, panels I231-h). The walls of the inflatable balloons (231-a-h) can be made from any suitable expandable or non-expandable material. Examples of expandable materials include polyurethane, any elastic polymer, thin film polymer (nylon, compliant polyamide, etc.), or other elastomers. The inflatable balloons (231-a-h) can have a limited maximum inflation size, whereby inflation above the maximum inflation size is resisted. A limited maximum inflation size can be achieved by forming the balloon wall from a non-expandable material, such as PET, semi-compliant, or non-compliant polyamide.

[0099] The inflation lumen (234) may be fluidly connected to the inflatable balloons (231, -a-h). The inflation lumen (234) may extend proximally (40) through an inflation tube (236), such as a catheter or flexible tubing. The inflation lumen (234) may be formed within the guide strand (218), as previously described. Thus, the guide strand (218) may be the inflation tube (236), as shown, for example, in panels G, H, and I of FIG. 3. Alternatively, the inflation tube (236) may be provided external to the elongate member (210), as shown, for example, in panels i, ii, iii, vi, vii, viii, xi, xii, and xiii of FIG. 3. The inflation tube (236) may extend proximally outside the elongate member (210).

[0100] The inflation lumen (234) allows inflation of the inflatable balloon lumen (232) from outside the body canal after the elongate member (210) is positioned. The inflatable balloons (231, -a-h) can be deflated after treatment by releasing inflation fluid (e.g., saline or sterile water) from the balloon lumen (232) via the inflation lumen (234). The inflation fluid may include a contrast agent. Figures 24-26 illustrate a placement tool (200) with an inflatable balloon assembly (230), in which inflatable balloons (231-e, 231-f, 231-h) are positioned within the uterine canal (604) and inflated to prevent or reduce sliding movement of the elongate member (210). Also shown is an inflation tube (236) for controllable inflation and deflation of the balloons (231-e, 231-f, 231-h). As previously mentioned, the inflation tube (236) is a guide strand (218).

[0101] The inflatable balloons (231-a-h) can be used to prevent the elongated member from being extruded from the uterine canal during effector shaft retrieval and improve uterine positioning. In this case, the balloons (231-a-h) can be inflated when the effector shaft (310) of the steering guide (300) is introduced into the elongated member (210). This can contribute to improving the accuracy of uterine positioning by reducing the degrees of freedom of the elongated member (210) within the uterine canal (604). Furthermore, as cervical tumors begin to shrink, the sutures securing the elongated member (210) to the cervix may loosen, potentially causing the elongated member to become dislodged. Inflating the balloons automatically secures the elongated member within the uterine canal. The balloons (231-a to 231-h) can be permanently inflated throughout the treatment period (e.g., 1 to 8 weeks) to prevent the elongated member (210) from becoming dislodged from the uterine canal (604), even between treatments.

[0102] The sliding limiter (220) may be an expandable stent (240). The expandable stent (240) may be disposed around at least the distal portion of the elongate member (210), as illustrated in panels v, x, xv, and xx of Figure 3. It may be made of any suitable expandable material, such as biodegradable metals such as CoCr alloys, Phynox, Nitinol, magnesium alloys, zinc alloys, iron, or biodegradable polymers. The expandable stent may be self-expanding or balloon-expandable. The stent may be covered with a slidable sheath that restricts its shape, allowing it to collapse after treatment. Expandable stents are well known in the art and typically have a tubular shape, with a radially expanding mesh structure in the wall, either cut from a tube or made from braided wire.

[0103] The stop member (250) may be provided at the proximal end of the elongate member (210), as illustrated in panels a, b, d, e, g, h, k, l, n, and o of Figure 3. The stop member functions as a distance limiter that prevents the elongate member (210) from sliding further into the tube when the elongate member (210) abuts the tube entrance. The stop member is disposed at the proximal end of the elongate member (210). The stop member protrudes from the outer surface of the elongate member (210). The stop member (250) is provided in a fixed (non-moving) relationship with respect to the elongate member (210). The stop member (250) may be rigid. The stop member may include an annular structure, which may be formed from the same material as the member (210) or a different material. The stop member (250) may be provided with one or more suture channels (252). The suture channel allows the stop member to be sutured to the entrance of the canal, for example, to the cervical bank. Figures 5 and 23-25, 26 illustrate an inserter (204) with a stop member (250) at the proximal end of the elongate member (210). The placement tool (200) is positioned within the cervix (602) or within the cervix (602) and uterine canal (604), and the stop member abuts the cervical bank (602) to prevent or reduce sliding movement of the elongate member (210).

[0104] The sliding limiter (220) may be a region of the distal portion of the elongate member (210) that includes one or more distal protrusions. The protrusions may be lateral protrusions (245), as illustrated in panels iv, ix, xiv, and xix of Figure 3. The protrusions may be annular rings or segments. The distal protrusions (245) function as a limiter that prevents or reduces further sliding of the elongate member (210) into the vessel when the elongate member (210) abuts the vessel wall. The distal protrusions (245) are disposed at the distal end of the elongate member (210). The distal protrusions (245) protrude from the outer surface of the elongate member (210). The distal protrusions (245) are provided in a fixed (non-moving) relationship with respect to the elongate member (210). The distal protrusions (245) may be rigid. The distal protrusions (245) may include an annular structure. It may be made from the same material as member (210) or from a different material.

[0105] The elongate member (210) may be provided with one or more drainage channels (270,-a,-b,-c) at its distal end (20), as shown, for example, in panels B, C, D, E, F, K, N, O, and P of FIG. 3 . The drainage channels fluidly connect the elongate member lumen (214) with the outer surface of the elongate member (210). The drainage channels (270,-a,-b) may be provided toward the distal end of the elongate member (210). The distal end of the elongate member (210) may be open to the elongate member lumen (214), thereby forming the drainage channels (270,-b). The guide strands (218) may be attached to struts (213) attached to the elongate member lumen (214) that do not obstruct the passage of fluid (e.g., panels C and O of FIG. 3 ). A drainage channel (270, -c) may be provided in the sidewall of the elongate member lumen (214). The drainage channel (270) allows for the safe removal of drainage of fluids that may build up within the uterine canal. Fluids exit the proximal end of the elongate member lumen (214) and enter, for example, the vaginal passageway (606) before and after simulation and / or radiation therapy treatments when the effector shaft is not inside the elongate member. The drainage channel allows fluids to be drained from the canal, significantly reducing the risk of infection. The drainage channel may also function as an exit port for the guide strand (218), or vice versa. The drainage channel may also function as a threaded passageway (272, -c) for the removable guide strand (218), or vice versa. The drainage channel may also function as a threaded passageway (272, -c) for the removable guide strand (218), or vice versa.

[0106] The inserter may be provided with any one of a number of different arrangements of drainage channels (270), lateral limiters (220), exit ports (272), threaded passages (272, -c), and guide strands (218). For example, a distal sliding limiter, a proximal sliding limiter, an exit port, and one or more drainage channels may or may not be provided. If both a drainage channel and distal sliding limiters (i-v) are present, the drainage channel may be adjacent to one of the ends of the distal sliding limiter. In FIG. 3 , any one of the elongate members (A, B, C, D) may be combined with a proximal sliding limiter (a, b) or may not be combined with a proximal sliding limiter (c). The elongate members (A, B, C, D) may or may not include distal sliding limiters (i, ii, iii, iv, v).

[0107] 3, any one of the elongated members (E, F) may be combined with a proximal sliding limiter (d, e) or may not be combined with a proximal sliding limiter (f). The elongated members (E, F) may or may not include a distal sliding limiter (vi, vii, viii, xiv, x). The guide strands are removable.

[0108] Furthermore, in Figure 3, any one of the elongate members (G, H, J) with a distal sliding limiter may be combined with a proximal sliding limiter (g, h) or may not be combined with a proximal sliding limiter (j). The guide strand is an inflation tube.

[0109] 3, any one of the elongated members (K, L) may be combined with a proximal sliding limiter (k, l) or may not be combined with a proximal sliding limiter (m). The elongated members (K, L) may or may not include distal sliding limiters (xi, xii, xiii, xiv, xv). The guide strands are removable.

[0110] Further, in FIG. 3, any one of the elongate members (M, N, O, P) may or may not be combined with a proximal sliding limiter (n, o). The elongate members (M, N, O, P) may or may not include distal sliding limiters (xvi, xvii, xviii, xiv, xv). The guide strand is a relaxation tube. When both distal sliding limiters (i-xx) and a drainage channel or exit port are present, the distal sliding limiters (i-xx) may be positioned within a region (e.g., 211) of the elongate member (210) that does not block the drainage channel.

[0111] Examples of various combinations are shown below in Tables 1a-1e. The exemplary elements referenced in Tables 1a-1e are shown in FIG.

[0112] [Table 1a]

[0113] Table 1a shows exemplary combinations of features for the introducer (204) when the guide strand (218) is a flexible cord (219). Key: A - elongate member, no drainage channel; B - drainage channel in elongate member at distal end; C - elongate member with open distal end; D - drainage channel in elongate member at distal end of side wall. a - proximal stop member (sliding limiter) with suture channel; b - proximal stop member (sliding limiter) without suture channel; c - no proximal stop member (sliding limiter); i - distal balloon pair (sliding limiter); ii - distal cone balloon (sliding limiter); iii - distal barrel balloon (sliding limiter); iv - distal protrusion (sliding limiter); v - expandable stent (sliding limiter); GS guide strand. Figure 3 shows an example implementation of each feature (A, B, C, D, a, b, c, i, ii, iii, iv, v).

[0114] [Table 1b]

[0115] Table 1b shows exemplary combinations of introducer features for cases where the guide strand is removable. Key: E—elongate member with an exit port as a passageway; F—elongate member with an open exit port at the distal end; d—proximal stop member (sliding limiter) with a suture channel and a reciprocating stop; e—proximal stop member (sliding limiter) without a suture channel and with a reciprocating stop; f—elongate member with a reciprocating stop and without a proximal stop member (sliding limiter); vi—distal balloon pair (sliding limiter); vii—distal cone balloon (sliding limiter); viii—distal barrel balloon (sliding limiter); ix—distal protrusion (sliding limiter); x—expandable stent (sliding limiter), GS guide strand. Figure 3 shows exemplary implementations of each feature (E, F, d, e, f, vi, vii, viii, ix, x).

[0116] [Table 1c]

[0117] Table 1c shows exemplary combinations of features for the introducer (204) when the guide strand (218) is an inflation tube (236). Key: G - elongate member with a pair of distal balloons (sliding limiter), H - elongate member with a distal conical balloon (sliding limiter), J - elongate member with a distal barrel balloon (sliding limiter). g - proximal stop member with suture channel (sliding limiter), h - proximal stop member without suture channel (sliding limiter), j - no proximal stop member (sliding limiter). Figure 3 shows exemplary implementations of each feature (G, H, J, g, h, j).

[0118] [Table 1d]

[0119] Table 1d shows examples of combinations of introducer features when the guide strand is removable. Key: K - elongate member (272,-c) with a threaded passage, L - guide strand attached to an elongate member with a breakable connection. k - proximal stop member (sliding limiter) with suture channel, l - proximal stop member (sliding limiter) without suture channel, m - no proximal stop member (sliding limiter). xi - distal balloon pair (sliding limiter), xii - distal cone balloon (sliding limiter), xiii - distal barrel balloon (sliding limiter), xiv - distal protrusion (sliding limiter), xv - expandable stent (sliding limiter), GS guide strand. Figure 3 shows an exemplary implementation of each feature (K, L, k, l, m, xi, xii, xiii, xiv, xv).

[0120] [Table 1e]

[0121] Table 1e shows exemplary combinations of features for the introducer (204) when the guide strand (218) is a relaxation tube (237). Key: M - elongated member, no drainage channel; N - elongated member drainage channel at distal end; O - elongated member open at distal end; P - elongated member drainage channel at distal end of side wall; n - proximal stop member (sliding limiter) with suture channel; o - proximal stop member (sliding limiter) without suture channel; p - no proximal stop member (sliding limiter); xvi - distal balloon pair (sliding limiter); xvii - distal cone balloon (sliding limiter); xviii - distal barrel balloon (sliding limiter); xix - distal protrusion (sliding limiter); xx - expandable stent (sliding limiter). FIG. 3 shows an exemplary implementation of each feature (M, N, O, P, n, o, p, xvi, xvii, xviii, xix, xx).

[0122] The placement tool (200) may further include a removable steering guide (300), as shown in FIGS. 5-21 and 26, for example, to control the position and / or orientation of the inserter (204). The steering guide (300) has a proximal end (40) and a distal end (20). The steering guide (300) may be removably attached to the inserter (204) or the elongate member (210). The steering guide (300) may be provided with a guide strand passageway (312) for slidable movement along the guide strand (218). The guide strand passageway (312) may be provided at least partially along the length of the steering guide (300), for example, along the effector shaft (310) and / or transmission (314), as described below.

[0123] An effector shaft (310) disposed at the distal end (20) of the steering guide (20) is configured for insertion into the elongate member lumen (214) along the guide strand (218). The effector shaft (310) is configured for (repeatable) slidable and removable insertion into the elongate member lumen (214). The effector shaft (310) may have a circular cross-sectional profile perpendicular to its longitudinal axis. The profile may have the same size in the axial direction. The profile may be tapered in the axial direction. A small profile may be present at the distal end.

[0124] The effector shaft (310) may be arranged with one or more indentations on its surface that cooperate with complementary protrusions on the inner surface of the elongate member lumen (214). This arrangement allows the effector shaft (310) to latch within the elongate member lumen (214). The effector shaft (310) can snap into place within the inserter (204). Removal of the effector shaft (310) is accomplished by pulling it, overcoming the force of the latch.

[0125] The effector shaft (310) is preferably rigid. Preferably, it is inflexible. It may be formed from a substantially rigid rod. It may have a straight shape, e.g., for use on the cervix and / or uterus, or it may have a curved shape.

[0126] The effector shaft (310) may be made of a biocompatible, radiovisible material, such as titanium or coated aluminum. To avoid artifacts under CT or PET / CT, it is preferably made of a low-density material. The effector shaft (310) may also be made of an MRI-compatible material, such as titanium or coated aluminum. It may also be made of a biocompatible, high-density material, such as tantalum. However, tantalum causes more artifacts under CT and PET / CT. To reduce artifacts under CT and PET / CT, a radioinvisible inserter (204) may be combined with a radiovisible effector shaft made of a low-density metal, such as titanium or coated aluminum.

[0127] The effector shaft (310) may be provided with a guide strand passageway (312) for slidable movement along the guide strand (218). The guide strand passageway (312) may be a lumen within the effector shaft (310) or a longitudinal groove in the surface of the effector shaft (310) (e.g., FIG. 10, and detailed view 10A). The guide strand passageway (312) may be provided at least partially along the longitudinal length of the effector shaft (310). An inlet (312,-a) to the guide strand passageway is located at the distal end, preferably the distal tip, of the effector shaft (310). The outlets (312,-b1 through -b5) from the guide strand passageway are located proximal (i.e., proximal side) of the inlet (312,-a). FIG. 6 illustrates various possible locations of the inlet (312,-a) and outlet (312,-b) of the guide strand passage (312) when the guide strand passage (312) is a lumen. The outlet (312,-b1) to the guide strand passage (312) can be located at the distal end of the effector shaft (310). The outlet (312,-b2) to the guide strand passage (312) can be located at the proximal end of the effector shaft (310). The outlet (312,-b3) to the guide strand passage (312) can be located at the distal end of the transmission (314). The outlet (312,-b4) to the guide strand passage (312) can be located in the middle portion of the transmission (314). The outlet (312,-b5) to the guide strand passage (312) can be located at the proximal end of the transmission (314).

[0128] In Figure 7, the inlet (312,-a) of the guide strand passage (312) is at the distal tip of the effector shaft (310), and the outlet (312,-b3) is located toward the distal end of the transmission (314). In Figure 8, the outlet (312,-b5) is located where the proximal end of the transmission (314) joins the distal end of the handle portion (316). In Figure 9, the inlet (312,-a) of the guide strand passage (312) is at the distal tip of the effector shaft (310), and the outlet (312,-b2) is located toward the proximal end of the effector shaft (310). The greater the distance from the inlet (a) to the outlet (b), the longer the guide strand (218). In Figures 15, 17 and 18, the inlet (312,-a) of the guide strand passage (312) is at the distal tip of the effector shaft (310) and the outlet (312,-b4) is towards the mid-section of the transmission (314).

[0129] The effector shaft (310) may be made from any suitable biocompatible material, such as medical grade non-ferromagnetic stainless steel, tantalum, titanium, polycarbonate, PEEK, carbon fiber, glass fiber, fiber reinforced polyarylamide resin (e.g., Ixef (Solvay)), aluminum (coated), etc.

[0130] Typically, treatment is first simulated under a CT scan, PETCT scan, or MRI. Subsequent treatment may include one or more X-rays in the treatment room. The effector shaft (310) is preferably made from a material that is compatible with medical imaging, such as CT, MRI, or X-ray. The material may or may not be visible on the medical image.

[0131] If the effector shaft (310) is visible on a medical image, the effector shaft (310)'s orientation can be determined directly from the medical image of the effector shaft (310). When simulating treatment under MRI, the effector shaft (310) can be fabricated from a low-density material, such as PEEK or polycarbonate, or a fiber-reinforced polyarylamide resin (e.g., Ixef (Solvay)), or from an MR-compatible (non-magnetic) material, such as aluminum or titanium, coated with a layer of biocompatible metal (titanium). For CT scan simulation, coated aluminum or titanium, PEEK, polycarbonate, or a fiber-reinforced polyarylamide resin (e.g., Ixef (Solvay)) (mixed with barium sulfate) also offer advantages due to reduced artifacts compared to using a high-density metal, such as stainless steel. Coated aluminum, PEEK, polycarbonate, or fiber-reinforced polyarylamide resin (e.g., Ixef (Solvay)) steering guide (300) (mixed with barium sulfate) is used in the simulation, while stainless steel is used in the processing. Aluminum steering guide (300) or PEEK, polycarbonate, or fiber-reinforced polyarylamide resin (e.g., Ixef (Solvay)) (mixed with or without barium sulfate) are used in the simulation and processing. Most modern imaging devices combined with radiotherapy treatment devices allow good visualization of metal structures or radiovisible polymers, such as the effector shaft (310). In this case, the effector shaft may be visible by itself, and the presence of an imaging marker visible by the imaging device may not be necessary.

[0132] If the effector shaft (310) is not visible or is not visible enough to determine the position and / or orientation of the inserter, one or more imaging markers (350, a, b) may be placed on the effector shaft (310). This is useful when performing imaging using the linear accelerator's imaging tools. The steering guide (300), and in particular the effector shaft (310), may be provided with one or more imaging markers that can be identified by medical imaging. The imaging markers may be provided in a fixed relationship to the effector shaft (310), for example, on the inner surface, outer surface, or body of the effector shaft (310). The imaging markers may be made of a different material than the effector shaft (310), for example, a heavy metal such as platinum, platinum-iridium, tantalum, or tungsten.

[0133] The effector shaft (310) may have a length (E) of 1 to 10 cm, preferably 4 to 10 cm, for insertion into the cervix / uterus. The maximum outer diameter may be 0.3 to 0.7 cm. The diameter of the effector shaft (310) may be uniform or may vary from the proximal end to the distal end. For example, the diameter may be larger toward the proximal portion and smaller toward the distal portion. The change in diameter may be gradual. The change in diameter may vary gradually over the length of the effector shaft (310). The effector shaft may adopt an angle alpha relative to the transmission (e.g., Figure 6). Angle alpha is measured in the plane formed between the transmission and the effector. If the handle and effector shaft are on the same side of the transmission (cis), angle alpha is less than 180 degrees. If the handle and effector shaft are on opposite sides of the transmission (trans), angle alpha is greater than 180 degrees. If the handle and effector shaft are coaxial or straight with respect to one another, the angle alpha is 180 degrees. See Table 2 and Table 2a for dimensions and angles suitable for various medical applications.

[0134] The handle portion (316) disposed at the proximal end (40) of the steering guide (300) is provided in a fixed relationship (position and orientation) with respect to the effector shaft (310). Thus, directional and / or positional movement of the handle portion (316) causes corresponding directional and / or positional movement of the effector shaft (310). The handle portion (316) is preferably rigid, preferably inflexible. It may be formed from a substantially rigid rod.

[0135] The handle portion (316) may have a length (H) of 2 to 50 cm, preferably 15 to 25 cm, for cervical / uterus applications. In very obese subjects, the handle portion (316) may be up to 40 or 50 cm in length. The diameter may be 0.3 to 3 cm, preferably 0.5 to 2 cm.

[0136] The handle portion can adopt an angle beta relative to the transmission (e.g., Figure 6). The angle beta is measured in the plane formed between the transmission and the handle portion. If the handle and effector shaft are on the same side of the transmission (cis), the angle beta is less than 180 degrees. If the handle and effector shaft are on opposite sides of the transmission (trans), the angle beta is greater than 180 degrees. See Table 2 and Table 2a for dimensions and angles suitable for various medical applications.

[0137] The handle portion (316) can be made from any suitable biocompatible material, such as medical-grade non-ferromagnetic stainless steel, tantalum, titanium, polycarbonate, PEEK, carbon fiber, glass fiber, fiber-reinforced polyarylamide resin (e.g., Ixef (Solvay)), polyphenylsulfone (PPSU), aluminum (coated), bioceramics such as aluminosilicates, styrene acrylonitrile, or bioceramic polymer materials. The handle portion (316) can be made from the same material as the transmission (314). The handle portion (316) can have the same diameter as the proximal end (40) of the transmission (314).

[0138] The handle portion (316) can be formed from an imaging-transparent material, such as a polymer rod or tube. For ease of manufacturing, the same material may also be used to form the transmission (314). This can reduce imaging artifacts caused by the transmission (314) in the vaginal region (606)—as will be discussed in more detail below. Examples of suitable polymers include polycarbonate. Other materials that can be used for the handle portion include glass fiber, carbon fiber, fiber-reinforced polyarylamide resins (e.g., Ixef (Solvay)), polyphenylsulfone (PPSU), bioceramics such as aluminosilicates, styrene acrylonitrile, and bioceramic polymer materials. Figures 7, 8, 15-18 show examples of steering guides (300) formed from a polymer handle portion (316) and a transmission (314), both of which have a larger diameter (e.g., 0.8-2.5 cm) compared to the effector shaft (310), which can be formed from a hard metal such as titanium or a hard polymer (polycarbonate, PEEK, fiber-reinforced polyarylamide resin).

[0139] The steering guide (300), particularly the handle portion (316) and / or the transmission (314), may be provided with one or more (e.g., two, three, or more) radio frequency identification (RFID) tags. The RFID tags enable identification of the steering guide (300). The system may be provided with an RFID tag reading unit including an RFID tag reader and a processor or an interface to the processor configured to prevent operation of the robot arm if the RFID tag does not match an expected RFID tag stored in the system. Because radiation oncology departments may have multiple steering guides of different sizes for use with different subjects (e.g., see Table 2 herein), providing an RFID tag prevents providing the wrong steering guide (300) to a subject. The RFID tag may be located within the body of the steering guide (300). In particular, it may be provided within a slot provided in the reinforcing strut (317) (see, e.g., Figures 15, 16, 17, 19-21). For example, it may be placed in a slot in the side of the handle (316). The RFID tag may be rewritable or non-rewritable. A non-writable RFID chip allows the steering guide to be attributed to only one patient, reducing workflow errors. The system cannot rewrite the steering guide RFID chip and use it on another patient.

[0140] The handle portion (316) may be configured to attach to a placement device. Preferably, the attachment is removable. The placement device is configured to adjust and fix the position and / or orientation of the handle portion (316) and, therefore, the effector shaft (310). The placement device typically has an end effector attachment (e.g., a set of jaws, a chuck) for removable attachment to the handle portion. It has a base that is fixed to the floor, ceiling, or a simulation or treatment table. Preferably, the base of the placement device is fixed or fixable to the simulation or treatment table between the subject's legs. The end effector has multiple degrees of freedom of movement (e.g., 3, 4, 5, 6, 7, 8) and end effector position and / or orientation. The placement device may have multiple links connected in a kinematic chain by revolute joints, also known as axes. Having multiple axes (e.g., 3, 4, 5, 6, 7, 8, etc.) allows the end effector to adopt a variety of controllable positions and orientations.

[0141] The joints of the placement device may be passive (non-powered). In a passive system, the joints may be manually adjustable, releasable, or lockable. Once the end effector pose (position and / or orientation) is manually set, the joints are locked, fixing the pose of the end effector attachment.

[0142] The joints of the placement device may be motorized. The placement device may be a robotic arm (RA), where the position of the joints, and therefore the pose (position and / or orientation) of the end effector attachment, can be controlled by electronic signals. The robotic arm may have a "zero gravity mode," where the weight of the arm is supported by the motorized joints, but the pose (position and / or orientation) of the end effector can be manually set and locked. Thus, the robotic arm can operate manually or under electronic control.

[0143] The RA may have a switchable zero-gravity mode. In zero-gravity on mode, the joints of the robotic arm may be supported or unsupported (e.g., by servos) to prevent the arm from collapsing. The orientation of the RA attachment may be manually guided by medical staff or the like. This facilitates connection between the placement tool (200) and the RA attachment when the placement tool (200) is already inserted into a subject. It also allows for manual fine-tuning of the orientation of the steering guide (300) for simulation and treatment. Once connection is made between the RA attachment and the handle portion (316), the zero-gravity mode may be deactivated, and operations may be performed as described elsewhere herein. An RA operating in zero-gravity on mode may continue to record the orientation of the RA attachment, so that when the zero-gravity mode is deactivated (zero-gravity off mode), the RA can continue to be controlled in a treatment or simulation orientation by the controller processing unit (440) and the steering guide (300) without an intervening calibration operation. Thus, upon entering zero-g-off mode, the RA attachment attitude is initially determined from the last registration of the RA attachment attitude upon exiting zero-g-on mode.

[0144] Robotic arms are known in the art and are manufactured, for example, by Universal Robots (Denmark) or Kuka (Germany).

[0145] The placement device (eg, a robotic arm) is typically positioned so that the end effector attachment is located between the patient's legs.

[0146] To facilitate attachment to a placement device, the handle portion (316) may be provided with a grip locator (300) comprising one or more notches (334) and / or one or more protrusions and / or one or more corners (332) that cooperate with an end effector attachment, which may comprise, for example, a set of jaws or a gripper of a chuck. The grip locator (300) is securely fastened within the closed gripper, limiting and preventing rotation and / or movement between the gripper and the handle portion (316). Exemplary grip locators are shown in FIGS. 11-16 and 19-21. The grip locator (300) may be located at the proximal end of the handle portion (316). The base of the notch (334) may be pointed, flat, or linear (e.g., with an elongated apex). The notch (334) may have straight (e.g., radiused) or chamfered sides. The grip locator (330) allows for highly accurate and repeatable removable attachment of the end effector attachment to the handle portion (316). The grip locator allows for highly repeatable gripping of the handle portion (316) by the gripper and reduced play and backlash. The end effector attachment coupled to the grip position (300) mounts the placement end effector attachment in fixed relationship to the grip position (300).

[0147] The gripper jaws may be provided with one or more protrusions that engage with grip locators (e.g., one or more notches) on the handle portion (316) when the gripper is closed. If the notch has chamfered sides, the chamfered protrusions on the gripper will align the steering guide (300) when closing.

[0148] Examples of notches (334) on a grip locator (330) are shown in Figures 11-13, 15A-15C, 16, and 19-21. In Figure 11, straight-sided notches (334), each with a flat base, are longitudinally separated and located at different radial positions; in Figure 12, a proximal set of straight-sided notches, each with a flat base, are located at the same longitudinal position but at different radial positions, with the distal set of notches located at a different longitudinal position than the proximal set at the same different radial position; and in Figure 13, the notches are arranged similarly to Figure 12, but they have chamfered (V-shaped) sides and a straight bottom. In Figures 15B, 15C, and 16, chamfered-sided (V-shaped) notches (334) with straight bases are located.

[0149] One or more corners (332) of the grip locator (330) may be positioned along the axial direction of the proximal end of the handle portion (316). The corners (332) may be square. There may be only one corner. The grip locator (330), which is a combination of the notch (334) and the corners (332), allows for a stable grip by the end effector attachment when the end effector attachment is a gripper with a pair of jaws. At least one notch and corner may have a different mutual orientation, preferably a perpendicular orientation. At least one notch may be provided within the longitudinal extent of the corner. For example, the corner may extend axially at the proximal end of the handle portion (316), while the base of the notch may extend perpendicular to the axial direction. This ensures completely reproducible fixation of the steering guide to the end effector attachment and eliminates further uncertainty in the position of the steering guide relative to the proximal end of the placement device.

[0150] 15A, 15B, and 15C, 16, the proximal end of the handle portion (316) is provided with a grip locator (330) having a single angle (332) axially aligned with the proximal end of the handle portion (316), with a chamfered sided (V-shaped) notch (334) having a straight base within the longitudinal extent of the angle. Figure 15A shows an end view of the handle portion (316) showing the angle (332).

[0151] The gripper jaws can close to form a profile similar to the cross section of the grip locator 330. In particular, the profile can complement the corners 332 of the grip locator 330. When the jaws are closed, the corners 332 nesting within the jaw profile ensure precise and stable alignment of the steering guide 300 with the placement device.

[0152] The handle portion (316) may be provided with a docking beacon (340) configured to provide information regarding the position and optional orientation of the steering guide (300) relative to the end effector attachment. The docking beacon (340) enables manual, semi-automatic, or automatic guidance of an end effector attachment comprising a gripper (e.g., a set of jaws, a chuck) to the handle portion (316), and in particular to the grip locator (330). The position and optional orientation of the steering guide (300) relative to the end effector attachment may be determined and tracked in real time.

[0153] An exemplary docking beacon (340) is shown in Figures 19-21. The orientation of the end effector attachment can be adjusted in real time as the end effector attachment approaches the handle portion (316) based on the orientation of the docking beacon (340) relative to the end effector attachment, allowing it to be mated without disturbing the orientation of the steering guide (300) already inserted into the target canal. A closed feedback loop can be used to guide the end effector attachment toward the target docking beacon (340). If the approaching end effector attachment deviates from the target handle portion (316), a correction to the approach direction is applied until the approach reaches the target. The closed feedback loop continuously checks and corrects the approach direction. The docking beacon (340) can be provided at the proximal tip of the handle portion (316). The docking beacon can be located on the handle portion (316) proximal to the grip locator (330). The docking beacon (340) may be passive or active, or a combination of passive and active. The docking beacon (340) may be detachable from the handle portion (316). The docking beacon (340) may be non-detachable from the handle portion (316).

[0154] The passive docking beacon consists of a body of a predefined geometric shape that can be recognized by a vision-guided robotic system (e.g., one or more cameras, laser scanners). Vision-guided robotic systems are well known in the art. The shape of the body and its orientation can identify the pose of the handle portion (316). The body of the passive docking beacon can be located at the proximal end, preferably the proximal tip, of the handle portion (316). It can be located proximal to the grip locator (330). An optical recognition system can be provided attached to the end effector attachment.

[0155] The body of the passive docking beacon may comprise multiple spheres (361i-iv), as shown in FIG. 19, for example. The number of spheres may be at least three. The positions and spacing of the spheres are predefined. The orientation of the handle portion (316) can be determined from a two-dimensional image of the spheres and their mutual distances. The distance from the handle portion to the end effector attachment can be determined from a two-dimensional image of the spheres and their diameters, which appear the same in all directions.

[0156] The body of the passive docking beacon may include a two-dimensional shape (344) (e.g., a rectangular shape), for example, as shown in FIG. 20. The rectangular shape is of a predefined size and shape. The orientation of the handle portion (316) can be determined from a two-dimensional image of the rectangle showing the structure cut out according to the orientation. The distance of the end effector attachment from the handle portion can be determined from a non-contact distance measuring device (e.g., a laser or ultrasonic range finder). If the optical recognition system is a laser scanner, a laser range finder may be incorporated.

[0157] The active docking beacon wirelessly transmits information that allows the position and / or orientation of the handle portion (316) to be determined. It may include a solid-state gyroscope (3-axis), a wireless transmitter (e.g., Bluetooth), a controller, and a replaceable or rechargeable power source. The approach angle of the end effector attachment can be adapted according to the attitude of the handle portion (316) transmitted by the active docking beacon. The distance between the end effector attachment and the handle portion (316) can be determined by a non-contact distance measuring device (e.g., a laser or ultrasonic range finder). An exemplary active docking beacon (342) is shown, for example, in FIG. 21 .

[0158] Another example of an active docking beacon is an array of position-determining radio transponders, as described elsewhere herein. The transponders' locations can be tracked in real time by spatial transponder detectors, which typically can achieve sub-millimeter, sub-degree accuracy. The transponders can receive power inductively or from an on-board power source, such as a battery in the steering wheel of a steering guide.

[0159] The handle portion 316 may be connected or connectable to the end effector attachment by manual guidance. If the placement device is a robotic arm (RA), manual docking may be achieved in RA zero-gravity mode. The RA may have a switchable zero-gravity mode. In zero-gravity-on mode, the joints of the robotic arm may be supported or unsupported (e.g., by servos) to prevent the arm from collapsing. The orientation of the RA attachment may be manually guided, for example, by medical staff. This facilitates connection between the placement tool 200 and the RA attachment when the placement tool 200 is already inserted into a subject. It also allows for manual fine-tuning of the orientation of the steering guide 300 for simulation and treatment. Once connection between the RA attachment and the handle portion 316 is made, the zero-gravity mode is deactivated, and operations may be performed as described elsewhere herein. An RA operating in zero-gravity on mode may continue to record the RA attachment's attitude so that when zero-gravity mode is deactivated (zero-gravity off mode), the RA can continue to be controlled in a treatment or simulation attitude by the controller processing unit (440) and steering guide (300) without an intervening calibration operation. Thus, upon entering zero-gravity off mode, the RA attachment's attitude is initially determined from the last registration of the RA attachment's attitude upon exiting zero-gravity on mode.

[0160] If the positioning device is a robotic arm (RA), docking can be achieved by setting the RA attachment on the radiation therapy treatment table to one of the treatment positions and attaching the RA attachment to the handle portion (316) of the steering guide (300) inside the patient. The steering guide (300) is introduced into the patient and placed in the same position as during the simulation using laser light and imaging, and then the robotic arm is adjusted to the same position (treatment position) reached during the simulation. The treatment position is maintained while the steering guide is manually connected to the effector end (gripper) of the robotic arm. Thus, the steering guide will be in the same position inside the patient as during the simulation.

[0161] The effector shaft (310) and the handle portion (316) may be connected by a transmission (314). The transmission (314) is typically a rigid rod. The transmission may be provided in a fixed connection and relationship (i.e., orientation and / or position) with both the effector shaft (310) and the handle portion (316). It may be straight, curved, or may include one or more angled bends. It may be formed from a substantially rigid rod. The rod may be hollow or solid.

[0162] The transmission (314) may have a length (T) of 1 to 30 cm, preferably 10 to 25 cm, and preferably 8 to 20 cm, depending on the type of tumor (e.g., Figure 6). The transmission (314) may have a diameter of 0.3 to 3 cm, preferably 0.3 to 1.5 cm. The handle portion and the plane formed between the transmission and effector shaft may adopt an angle gamma relative to each other (e.g., Figure 6A). See Tables 2 and 2a for dimensions and angles suitable for various medical applications.

[0163] The diameter may be uniform from the proximal end to the distal end, or it may vary. For example, the diameter may be larger toward the proximal portion of the transmission and smaller toward the distal portion. The diameter change may be gradual. A smaller distal diameter may be more traumatic to enter the vagina, while a larger diameter toward the proximal portion may increase the stiffness of the steering guide (300).

[0164] The handle portion (316) may be continuous with the transmission (314). The transmission (314) may have the same diameter (e.g., 0.3-3 cm, preferably 0.5-2 cm) as the handle portion (316) along a portion of its proximal length, e.g., 2.5-3 cm of the proximal length of the transmission (314). By having the larger diameter handle portion (316) continuous with the proximal portion of the transmission (314), the steering guide (300) can be strengthened. Reinforcing struts (317) may be positioned at the corners between the handle portion (316) and the transmission (314) (e.g., Figures 15, 16, and 17).

[0165] The distal portion (20) of the transmission (314) can have a smaller diameter (0.3-1 cm) to make it atraumatic due to its diameter (atraumatic when entering the vagina).

[0166] The guide strand passage (312) may extend from the effector shaft (310) to the transmission (314). The guide strand passage (312, ab) may be a lumen within the transmission (314) or a longitudinal groove in the surface of the transmission (314). The guide strand passage (312) may extend at least partially along the longitudinal length of the transmission (314). In FIG. 6, possible guide strand passage (312) exits on the transmission at the distal end (312, -b3), midsection (312, -b4), or proximal end (312, -b5). In FIG. 7, the guide strand passage (312) exits at the distal end (312, -b3) of the transmission. In FIG. 8, the guide strand passage (312) exits at the proximal end (312, b5) of the transmission. In Figures 15, 17 and 18, the exit of a possible guide strand passage (312) on the transmission is in the central section (312, -b4).

[0167] An inflatable transmission balloon (322) can be provided toward the distal end (20) of the transmission (314), as shown, for example, in Figures 6, 9, 16, 17, 18, and 26. The inflatable transmission balloon (322) can be used to dilate the vagina, preferably to a known or fixed diameter, for radiation therapy. Furthermore, the transmission (314) can be centered within, for example, the vaginal passageway (606). In its expanded state, it can help position the vaginal passageway (606) at a predetermined location and / or orientation and / or diameter for radiation therapy treatment. The diameter of the transmission (314) can be smaller at the distal end (20), allowing the inflatable transmission balloon (322) to enter the vaginal passageway (606) with a narrower transmission (314) with less pain. Inflation of the inflatable transmission balloon (322) dilates the vaginal walls to position them. The wall of the inflatable transmission balloon (322) can be made of any suitable expandable or non-expandable material. Examples of expandable materials include latex, any elastic polymer, thin-film polymer (such as polyurethane), or other elastomers. The inflatable transmission balloon (322) can have a limited expansion size (maximum) whereby expansion beyond the maximum expansion size is resisted (a semi-compliant or non-compliant balloon). In other words, the inflatable transmission balloon (322) can have limited expansion, whereby expansion reproducibly stops at the limited expansion size. Continued expansion with hydraulic pressure above the limited expansion size does not result in further expansion. The limited expansion size is reproducible, for example, over one or more additional treatment sessions. A reproducible limited expansion size ensures that the target is in a corrective position for a specific treatment posture because expansion stops once the limited size is reached. The distance between the inflated balloon wall and the effector shaft is known and / or reproducible. The limited inflation size reduces placement errors in subsequent treatment sessions, especially when repeated treatments are performed in a fractionated treatment program.A limited maximum inflation size can be achieved by forming the balloon wall from a non-expandable material, such as PET, non-compliant, or semi-compliant polyamide. The inflatable transmission balloon (322) can have a maximum inflation diameter of 2.0 to 5 cm. Examples of transmission balloon (322) dimensions and medical applications are shown in Tables 2 and 2a.

[0168] Fluidly connected to the inflatable transmission balloon (322) may be an inflation lumen extending proximally (40) via an inflation tube, such as a catheter or flexible tubing. This structure may be internal to the transmission portion (314) or parallel to the transmission portion (314). The inflatable transmission balloon (322) may be deflated by release of inflation fluid (e.g., saline) after simulation and / or after each session or period of radiation therapy treatment, thereby allowing the steering guide (300) to be withdrawn.

[0169] Fluidly connected to the inflatable transmission balloon (322) is an inflation lumen (328) extending proximally (40) of the steering guide (300) (e.g., FIGS. 17 and 18). The inflation lumen (328) may be within the body of at least a portion of the transmission section (314). The inflation lumen (328) may be external and parallel to at least a portion of the transmission section (314). A fitting (329) (e.g., a Luer fitting) may be disposed at the proximal end of the inflation lumen (328) for connection to a pump. The inflatable transmission balloon (322) may be deflated by release of inflation fluid (e.g., saline or sterile water) after simulation and / or after each session or period of radiation therapy treatment, thereby allowing the steering guide (300) to be withdrawn.

[0170] The transmission balloon (322) can be inflated with saline or sterile water. Optionally, it can contain 0.5-4% contrast agent to make the transmission balloon visible on CT simulation images and / or images created prior to the radiation therapy session or period. Alternatively, the transmission balloon (322) can be provided with one or more imaging markers (e.g., imaging visible wires (longitudinal, helical, circular)). One or more wireless location transponders can be disposed on the inflatable transmission balloon (322).

[0171] An inflatable transmission balloon (322) may be provided toward the distal end (20) of the transmission (314), where: - optionally, the inflatable transmission balloon (322) has a fixed maximum inflated diameter; and / or Optionally, the inflatable transmission balloon (322) carries one or more imaging markers that are visible by medical imaging, and / or Optionally, the inflatable transmission balloon (322) carries one or more wireless transponders for determining the position and / or orientation of the transmission (314) and / or effector shaft (310) by means of a spatial transponder detector.

[0172] The transmission (314) can be made from any suitable biocompatible material, such as medical-grade non-ferromagnetic stainless steel, tantalum, titanium, polycarbonate, PEEK, carbon fiber, fiber-reinforced polyarylamide resin (e.g., Ixef (Solvay)), polyphenylsulfone (PPSU) fiberglass, aluminum (coated), bioceramics such as aluminosilicates, styrene acrylonitrile, or bioceramic polymer materials. The transmission (314) can be made from the same material as the handle portion (316). The proximal end of the transmission (314) can have the same diameter as the distal end of the handle portion (316).

[0173] The transmission (314) can be formed from an imaging-transparent material, such as a polymer rod or tube. For ease of manufacturing, the same material can be used to form the handle portion (316). This can reduce imaging artifacts caused by the transmission (314) in the vaginal region (606), as described in more detail below. Examples of suitable polymers include polycarbonate, polyphenylsulfone (PPSU), and fiber-reinforced polyarylamide resins (e.g., Ixef (Solvay)). Other materials that can be used for the handle portion include fiberglass, carbon fiber, bioceramics such as aluminosilicates, styrene acrylonitrile, bioceramic polymer materials, biocompatible polymeric hard materials, and the like. Figures 7, 8, 15, 16, 19-21 show examples of steering guides (300) formed from a polymer handle portion (316) and a transmission (314), both of which have a larger diameter (e.g., 0.8-2.5 cm) compared to the effector shaft (310), which may be formed from a harder metal such as titanium.

[0174] If the transmission (314) is not visible or is not sufficiently visible to determine the position and / or orientation of the inserter, one or more imaging markers (350, a, b, c) may be placed on the transmission (314). This is useful when performing imaging using the linear accelerator's imaging tools. The steering guide (300), and particularly the transmission (314), may be provided with one or more imaging markers that can be identified by medical imaging. The imaging markers may be provided in a fixed relationship to the transmission (314), for example, on an inner surface, an outer surface, or within the body of the transmission (314). The imaging markers may be made of a different material from the transmission (314), for example, a heavy metal such as platinum, platinum-iridium, tantalum, or tungsten. FIG. 16 shows one or more imaging markers (350, a, b, c) placed on the transmission (314).

[0175] The polymer rod or tube for the transmission (314) may have a larger diameter (e.g., 1 cm) compared to a transmission (314) made from a stronger material, such as titanium or stainless steel. The polymer transmission (314) may significantly reduce artifacts and contribute to obtaining superior images of diseased structures. Some imaging artifacts may arise from any imaging markers present on the transmission (314) or effector shaft (310), which may be made from titanium corresponding to the endocervical portion and any imaging markers placed on the inserter (204), but are less significant than if the entire steering guide (300) were made from metal (e.g., titanium, non-ferromagnetic steel, coated aluminum).

[0176] If made of a polymer or ceramic material, the material of the transmission portion (314) may be mixed with a radiovisible material, such as barium sulfate, for radiovisibility on simulation and control images performed before each radiation therapy session. For radiovisibility, the surface of the transmission portion may be covered with a radiovisible longitudinal circular spiral marker made of a metal (e.g., thin titanium or tantalum wire) or a material mixed with barium sulfate, for example. If made of a polymer material, the transmission portion may also include a radiovisible marker within its structure.

[0177] Angle (alpha) (e.g., FIG. 6) can be formed between the effector shaft (310) and the transmission (314) in the range of 90 to 240 degrees, depending on the location and ease of access of the canal, e.g., the cervix or uterus. An angle (beta) (e.g., FIG. 6) can be formed between the handle portion (316) and the transmission (314) in the range of 70 to 150 degrees, depending on the ease of access. An angle (gamma) (e.g., FIG. 6A) can be formed between the effector shaft (310) and the plane formed by the transmission (314) and the handle portion (316) in the range of 0 or -90 to +90 degrees, depending on the ease of access. See Tables 2 and 2a for dimensions and angles suitable for various medical applications.

[0178] [Table 2]

[0179] Table 2: Exemplary dimensions of the elongate member and steering guide and transmission balloon components. Dimensions may exceed some of the presented subject matter, but are not limited thereto.

[0180] [Table 2a]

[0181] Table 2a: Exemplary dimensions of the elongate member and steering guide and transmission balloon components. Dimensions may exceed some of the presented subject matter, but are not limited thereto.

[0182] As shown in FIG. 26, the inserter (204) moves in response to movement of the effector shaft (310), which in turn moves in response to movement of the transmission (314) and ultimately the handle (316). By positioning the inserter (204), the cervix (602), tissue surrounding the cervix, and uterus (604) can be adjusted and maintained in a fixed position. By inflating the inflatable transmission balloon (322), tissue surrounding the vaginal passageway (606) can also be adjusted and maintained in a fixed position.

[0183] The steering guide (300), in particular the effector shaft (310) and / or the transmission (314) and / or the handle portion (316) and / or the transmission balloon, may be present and equipped with one or more (e.g., two, three or more) position-determining radio transponders (352, a, b, c) that can determine and track their position using spatial transponder detectors.

[0184] The terms positioning radio transponder and transponder are used interchangeably herein. Transponders are sometimes known as beacon transponders. In Figure 16, three transponders (352, a, b, c) are fixedly mounted at different locations on the exterior or interior of the transmission (314). The same transponders (352a-c) are visible on medical images and therefore also function as imaging markers (350a-c).

[0185] A transponder is a device that emits an electromagnetic pulse at a specific radio frequency that can be detected by a spatial transponder detector, typically containing multiple spatially separated receivers (coils). The timing of the pulses detected by the multiple spatially separated receivers in a position transponder reader allows the transponder's location to be accurately determined. Transponders are sometimes known as beacon transponders. Transponders can receive power inductively. Transponders can be powered by an internal power source, such as a battery in the steering guide's handle. When multiple transponders are present, each transponder can emit a signal at a different radio frequency. If at least three separately identifiable transponders are placed at different locations on the steering guide (300), the direction of the effector shaft (310) can also be determined. Examples of such systems are described, for example, in U.S. Patent Nos. 9,248,003 B2 and 9,072,895.

[0186] The use of a transponder reduces the need to align the effector shaft (310) and / or transmission (314) several times prior to radiation therapy treatment using medical imaging, reducing exposure to imaging radiation.

[0187] The transponder allows for real-time capture of the position of the effector shaft (310) and / or transmission (314) during simulation. The transponder also allows for real-time automated guidance (e.g., by a robotic arm) of the position and / or orientation of the effector shaft (310) and / or transmission (314) during treatment to align with a reference pose determined during simulation.

[0188] The transponders also allow for real-time manual guidance, modification, and fixation of the position and / or orientation of the effector shaft (310) according to the position and orientation information captured by the spatial transponder detectors. For example, in a closed feedback loop, the continuous input is the pose of the steering guide (300) and thus the effector shaft (310) determined by one or more (e.g., two, three, or more) position-determining wireless transponders, providing the operator with guidance to manually align the pose of the steering guide (300) and thus the effector shaft (310) with the pose determined during the simulation. In this scenario, the steering guide (300) may be attached by a handle portion (316) to a manually controllable positioning device (e.g., a manually adjustable positioning device with lockable passive joints, or a positioning device that is a robotic arm operating in manual zero-gravity mode). The same transponders and manual control may also allow for the capture and storage of the pose of the steering guide (300) and thus the effector shaft (310) during the simulation.

[0189] According to one aspect: The imaging marker or markers carried by at least a portion of the effector shaft (310) and / or the inserter (204) are visible by medical imaging, in particular X-ray medical imaging and / or MR medical imaging. and / or - one or more imaging markers carried on at least the distal part of the transmission (314) and / or the inserter (204) are visible by medical imaging, in particular by X-ray or MR medical imaging. and / or - The transmission (314) and / or the effector shaft (310) are arranged with one or more wireless transponders carried by the inserter (204) to determine the position and / or orientation of the transmission (314) and / or the effector shaft (310) by means of a spatial transponder detector.

[0190] Treatment is typically performed in a two-phase protocol. The first phase, called simulation, involves acquiring internal medical images of the subject, usually in three dimensions (e.g., from CT or MRI), while precisely aligning the subject with the imaging device on a mobile treatment simulation table. These medical images are used in the second phase of treatment planning. From the images, radiologists determine which tissue structures will receive high doses, low doses, sensitive structures, etc.

[0191] Treatment is typically performed using a linear accelerator to deliver ionizing radiation for radiotherapy. Information obtained during simulation is used to set many parameters of the linear accelerator, including patient position, head movement angle, beam intensity, beam energy, and leaf collimator profile, if present. The linear accelerator may incorporate a low-resolution medical imaging device to rapidly acquire medical images of the subject (e.g., by CT, MRI) to confirm the tissue locations determined during simulation.

[0192] The medical imaging device (simulation) and the linear accelerator are usually located in separate rooms.

[0193] The patient's position relative to the medical imaging device is recorded by placing the subject in a known position relative to the medical imaging device and marking a tattoo on the subject at one or more locations where the projected laser reference lines intersect. The treatment room containing the linear accelerator is equipped with equipment that projects a similar pattern of laser reference lines that intersect at known locations relative to the linear accelerator. Aligning the tattoo with the laser lines reveals the subject's position relative to the linear accelerator. The three-dimensional image recorded by the medical imaging device in one room can be transposed to a radiation treatment volume by a linear accelerator in another room at a later time.

[0194] Before radiation therapy begins, the patient is examined, optionally under anesthesia, and if the tumor is inoperable, the elongated member (210) of the inserter (204) is typically inserted into the target canal (e.g., the cervix). Once in place, the existing sliding limiter (220) is actuated, for example, by suturing the proximal stop member (250), and / or by inflation of the balloon assembly (230), and / or by expansion of the stent (240).

[0195] Before the simulation, the patient lies on the simulation table. The effector shaft (310) of the steering guide (300) is introduced along the trailing guide strand (218) and slidably inserted into the elongated member lumen (214). This step can be performed by the subject themselves. If present, the transmission balloon (322) is inflated with water possibly mixed with 0.5-4% contrast agent. The subject is positioned on a body support (e.g., a simulation couch or table) whose position and / or orientation can be adjusted relative to the imaging device. The patient may be asked to lie in a comfortable position on the simulation table. This allows the patient to find the optimal position on the simulation table for all subsequent treatments. Typically, contrast agent is injected intravenously to better visualize the pelvic vasculature, tumor, and lymph nodes. Once the target's position is confirmed by the radiation oncologist, the target is given markings (e.g., tattoos, reflective markings) on their bare skin to enable accurate positioning of the body relative to the body support, and a laser beam positioned along the patient's axis and sides is used during the radiation therapy treatment session. Medical imaging acquired during the simulation can determine the location of the tissue to be treated. The orientation and / or position of the elongated member (210) and / or effector shaft (310) and / or transmission portion (314) can also be monitored by medical imaging and adjusted by corresponding movement of the handle portion (316). The appropriate orientation and / or position of the elongated member (210) and / or effector shaft (310) and / or transmission portion—which optimally positions the tissue relevant to the treatment—can determine which of these positions will be used as the reference position. The optimal position of the positioning tool (200) can be determined during the simulation, which is typically performed using a CT scan (or, less frequently, an MRI, or a two-step process that fuses the MRI and simulated CT images).For example, if it is determined that the cervix may be positioned too posteriorly, a high dose can be directed to the entire rectal volume. Using a positioning device (e.g., manual or robotic arm), the uterus can be gently moved to a more anterior position during the simulation. This same position is then repeatedly replicated in each treatment session. After the simulation, the tumor and all organs are depicted on each CT slice during the treatment phase. This allows for the prescription of a therapeutic dose to each tumor tissue (e.g., cervix, uterus, bladder, lymph nodes) and prevents the delivery of too high a dose to healthy tissue (e.g., spinal cord, intestine, kidneys).

[0196] Calculations are typically performed by a computer to determine the direction, location, intensity, duration, and frequency of radiation therapy treatments, optimized taking into account the fixed positions of the elongate member (210) and / or effector shaft (310). After simulation, the steering guide (300), effector shaft (310), and possibly the transmission section are removed along with the trailing guide strand (218). This can be performed by the subject. The trailing guide strand (218) can be taped to the subject's skin, e.g., one of the patient's groin areas. The inserter (204) remains in place, e.g., for the next day or week of treatment. It is expected that the position of the tissue structures will have shifted prior to the actual treatment, e.g., due to factors such as lack of fixation to the pelvis, an empty or full bladder, and an empty or full colon.

[0197] Immediately prior to the radiation therapy treatment (e.g., several hours or minutes), the subject is positioned relative to the ionizing radiation therapy head on a body support (e.g., a treatment couch or table) to receive the therapeutic ionizing radiation, e.g., using the aforementioned markings on the bare skin and axial and lateral laser beams. The steering guide (300) effector shaft (310) is introduced along the trailing guide strand (218) and slidably inserted into the elongated member lumen (214). This step can be performed by the subject themselves. In fact, the patient will experience immediate discomfort upon any sudden movement. More precise positioning of the patient on the treatment table is typically achieved using medical imaging assistance (e.g., provided by an X-ray imager positioned relative to the ionizing radiation therapy head) to align the pelvis with the pelvic position determined during the simulation. The orientation and / or position of the elongate member (210) and / or effector shaft (310) can be monitored by medical imaging (typically X-ray) and / or a transponder and adjusted by movement of the corresponding handle portion (316). For example, a positioning device (e.g., a manual device or robotic arm) can be used to align the elongate member (210) and / or effector shaft (310) and / or transmission portion with a reference orientation. Once the orientation and / or position of the elongate member (210) and / or effector shaft (310) and / or transmission portion are set, the external radiotherapy treatment portion (one of several) can begin. The position of the inserter (204) remains fixed throughout the session or period. At the end of the treatment portion, the transmission balloon (322), if present, is deflated by a technician or nurse, and the effector shaft (310) of the steering guide (300) is removed along with the subsequent guide strand (218). This can be performed by the subject. The inserter (100) remains in place, ready for the next radiotherapy treatment, for example, the next day or the following week. The treatment period for such radiation therapy is divided into 1 to 35 sessions.

[0198] As previously mentioned, the placement tool (200) may be provided with a transponder to enable real-time capture of the position of the placement tool (200) during simulation or treatment. The transponder may be provided on the inserter (204) and / or the steering guide (300). In the steering guide, the transponder may be provided on the effector shaft (310), and / or on or in the transmission (314), and / or on or in the handle portion (316), and / or on the inflatable transmission balloon (322), if present.

[0199] The transponders enable real-time guidance of the placement tool (200) during treatment to align it with the reference orientation determined during simulation. The guidance provided can be manual, semi-automated, or automated using a robotic arm. The transponders enable real-time guidance, modification, and fixation of the position and / or orientation of the effector shaft (310) or inserter (204) according to position and orientation information captured by the spatial transponder detector. For example, in a closed feedback loop, continuous input is the orientation of the effector shaft (310) or inserter (204) determined from one or more (e.g., two, three, or more) position-determining wireless transponders, which can provide guidance to align the orientation of the effector shaft (310) or inserter (204) with the orientation determined during simulation. This allows for fine-tuning of the orientation of the placement tool (200) during in-situ simulation or treatment.

[0200] The transponder's real-time guidance may be manual, providing information (e.g., graphical, audible, force feedback) to guide the operator as they manually move and / or secure the placement tool (200). In this scenario, the steering guide (300) may be attached to a manually controllable placement device (e.g., a robotic arm operating in manual zero-gravity mode) by a handle portion (316). The same transponder and manual control may also enable the capture and storage of the pose of the steering guide (300) and, therefore, the effector shaft (310) during the simulation.

[0201] The real-time guidance of the transponder is automatic and provides information to the robotic arm, allowing the actuation of the robotic arm's joints to automatically move the placement tool (200).

[0202] The real-time guidance may be semi-automatic, providing information to the robotic arm and operator to allow partially automatic and partially manual movement of the placement tool (200).

[0203] The transponders function well below the surface of the subject. Not all transponders need to be located inside the patient's body. Transponders located on or within the placement tool (200) need not all be located inside the body. For example, one or two transponders can be located on or within the placement tool (200) in a portion that will be inside the patient's body (e.g., on the inserter (204), the effector shaft (310), or on or within a distal portion of the transmission (314) of the steering guide (300)), while one or two transponders can be located outside the patient's body (e.g., on or within a proximal portion of the transmission (314) of the steering guide (300)).

[0204] In certain prior art techniques, transponders can be implanted within the body to track the location of organs. The present placement tool (200) avoids the need for implantation. The transponders are placed on or within a portion of the placement tool outside the body (e.g., the inserter (204), the steering guide (300)) and are introduced into the body temporarily for only a few minutes each time. These transponders track objects within the body and are placed on the object, not embedded, and some (one or two) can be left outside the body to track the object. This eliminates the need to implant transponders in the subject.

[0205] The wearable inserter facilitates precise, reproducible placement of the tube and surrounding tissue, reducing the need to spread the radiation beam to account for tissue that typically shifts position between treatment segments. It also stabilizes the tube and surrounding tissue during irradiation. In practice, the safety margin can be reduced to millimeters instead of centimeters, significantly reducing radiation exposure to adjacent organs and tissues. For example, if the cervix is ​​treated, irritation to the bladder, rectum, bowel, and pelvic wall is reduced. Because the beam volume is more concentrated (i.e., reduced), the radiation dose can be increased during external beam radiation therapy (conformal radiotherapy), avoiding the need for brachytherapy. For example, for a cervical tumor 4 cm high and 5 cm in diameter, if the classical safety margin is 16 mm, the volume treated with a high dose would be 380 cm. 3 The positioning tool (200) allows the cervix to be fixed and repositioned in the same position before each radiation period, allowing for narrower margins (e.g., 4 mm) to be implemented, resulting in a high-dose volume of 126 cm. 3 This can reduce toxicity by a factor of 3.3, which has a very beneficial effect on reducing toxicity.

[0206] The wearable inserter eliminates the need to sedate the patient before radiation therapy treatment, which reduces trauma to the patient and reduces repeated trauma between treatment sessions. The guide strand allows the user (radiation oncologist, physician, radiologist, subject) to easily locate and operate the steering guide from outside the subject. In gynecological applications, it eliminates the need for a speculum. The patient can also insert the steering guide themselves. The guide strand allows repeated attachment and detachment of the steering guide before and after fractionated treatment. Access to the elongated member lumen (214) is possible even while the wearable inserter is momentarily positioned in situ in the cervix.

[0207] Also provided herein is a computer-implemented method for improving accuracy of site-specific radiation therapy of a subject's body tissue that is a target of radiation therapy treatment, comprising: - receive data relating to: o The position and / or orientation of the placement tool (200) with the inserter (204) positioned within the canal of the subject; A method is provided that includes outputting instructions to a placement device (e.g., a robotic arm) to use and adjust the position and / or orientation of the placement tool (200) according to a reference posture of the placement tool (200), thereby adjusting the position and / or orientation of the vessel and body tissue, wherein the reference posture is determined during a treatment simulation procedure.

[0208] Also provided herein is a computer-implemented method for improving accuracy of site-specific radiation therapy of a subject's body tissue that is a target of radiation therapy treatment, comprising: - receive data relating to: o The position and / or orientation of the inserter (204) placed within the canal, and / or o the position and / or orientation of the effector shaft (310) of the steering guide (300) located within the elongate member lumen (214) of the inserter (204); - outputting commands to a placement device (e.g., a robotic arm) and using a steering guide (300) to adjust the position and / or orientation of the inserter (204) according to a reference orientation of the inserter (204) and / or the effector shaft (310) and / or the transmission portion (314), thereby adjusting the position and / or orientation of the tube and body tissue, wherein the reference orientation was determined during a treatment simulation procedure.

[0209] The position and / or orientation of the placement tool (200) and / or inserter (204) and / or effector shaft (310) can be determined from medical images taken immediately prior to (e.g., minutes or hours after) the radiation therapy treatment, or from the position of a transponder attached to the placement tool (200) and / or inserter (204) and / or effector shaft (310) and / or the handle portion of the transmission or steering guide. The reference pose can be determined during a simulation of the treatment relative to the patient's structures (bones, pelvis). The radiation therapy treatment can be a fractionated treatment.

[0210] Also provided herein is a computer-implemented method for improving accuracy of site-specific radiation therapy of a subject's body tissue that is a target of radiation therapy treatment, comprising: (a) receiving data by computer relating to: o The position and / or orientation of the placement tool (200) at which the inserter (204) is placed within the canal of the subject. The position and / or orientation of the placement tool (200) is determined from:

[0211] one or more transponders (260, a, b, c) attached to the inserter (204), and / or one or more transponders (352a, b, c) attached to the steering guide (300), and / or one or more optically detectable landmarks (346i-iv, a, b, c) attached to the steering guide (300); (b) outputting to a computer graphical user interface a real-time indication of the position and / or orientation of the placement tool (200) compared to a reference pose of the placement tool (200) determined during the simulation procedure.

[0212] Also provided herein is a computer-implemented method for improving accuracy of site-specific radiation therapy of a subject's body tissue that is a target of radiation therapy treatment, comprising: (a) receiving data by computer relating to: o The position and / or orientation of the inserter (204) placed within the canal, and / or o the position and / or orientation of the effector shaft (310) of the steering guide (300) located within the elongate member lumen (214) of the inserter (204); The position and / or orientation of the inserter (204) or effector shaft (310) is determined from the following:

[0213] one or more transponders (260, a, b, c) attached to the inserter (204), and / or one or more transponders (352, a, b, c) attached to the steering guide (300), and / or one or more optically detectable landmarks (346i-iv) attached to the steering guide (300); (b) compared to a reference position of the inserter (204) and / or effector shaft (310) determined during the simulation procedure; the position and / or orientation of the inserter (204), and / or and outputting a real-time indication of the position and / or orientation of the effector shaft (310) to a graphical user interface of the computer.

[0214] Also provided are computing devices or systems configured to perform the computer-implemented methods described herein.

[0215] Also provided is a computer program or computer program product having instructions that, when executed by a computing device or system, cause the computing device or system to perform the computer-implemented methods described herein.

[0216] Also provided is a computer readable medium having stored thereon a computer program as described herein.

[0217] Also provided is a computer-readable medium having stored thereon instructions that, when executed by a computing device or system, cause the computing device or system to perform the computer-implemented methods described herein.

[0218] Also provided is a data stream representing a computer program or computer program product described herein.

[0219] Also provided is a system including: - a placement tool (200) as described herein, - a placement device for adjusting and fixing the position and / or orientation of the handle portion (316) and the effector shaft (310) of the placement tool (200); where The handle portion (316) is configured to be removably attached to a placement device; The placement device is a robotic arm.

[0220] Provided herein are methods for treating bodily tissue in a subject that is a target for radiation therapy treatment using site-specific fractionated radiation therapy, comprising: (a) receiving data by computer relating to: o the position and / or orientation of the placement tool (200) where the inserter (204) is placed within the canal; and / or (b) outputting computerized instructions to a placement device (e.g., a robotic arm) to use and adjust the placement tool (200) according to the reference orientation of the placement tool (200), thereby adjusting the position and / or orientation of the vessel and body tissue to replicate the position of the placement tool (200) during the treatment simulation procedure; (c) maintaining the position and / or orientation of the positioning tool (200) during the site-specific fractionated radiation therapy; (d) removing the steering guide (300); (e) repeating steps (a) through (d) for one or more subsequent portions of the site-specific fractionated radiation therapy.

[0221] Also provided herein is a method of treating a subject's body tissue that is a target for radiation therapy treatment using site-specific fractionated radiation therapy, comprising: (a) receiving data by computer relating to: o The position and / or orientation of the inserter (204) placed within the canal, and / or o the position and / or orientation of the effector shaft (310) of the steering guide (300) located within the elongate member lumen (214) of the inserter (204); (b) outputting computerized instructions to a positioning device (e.g., a robotic arm) to adjust the position and / or orientation of the inserter (204) using the steering guide (300) according to the reference orientation of the inserter (204) and / or the effector shaft (310) and / or the transmission portion (314), thereby adjusting the position and / or orientation of the vessel and body tissue and reproducing the position of the inserter (204) and / or the effector shaft (310) and / or the transmission portion (314) as during the treatment simulation procedure; (c) maintaining the position and / or orientation of the inserter (204) during the site-specific fractionated radiation therapy; (d) removing the steering guide (300); (e) repeating steps (a) through (d) for one or more subsequent portions of the site-specific fractionated radiation therapy.

[0222] Provided herein are methods for treating bodily tissue in a subject that is a target for radiation therapy treatment using site-specific fractionated radiation therapy, comprising: (a) determining: o the position and / or orientation of the placement tool (200), the inserter (204) being placed within the canal of interest, the position and / or orientation of the placement tool (200) being determined from one or more transponders (260, a, b, c) and / or one or more optically detectable landmarks (346i-iv) attached to the placement tool (200); (b) outputting to a computer graphical user interface a real-time indication of the position and / or orientation of the placement tool (200) compared to a reference pose of the placement tool (200) determined during the simulation procedure; and (c) manually adjusting the position and / or orientation of the placement tool (200) until it matches the reference orientation of the placement tool (200); (d) maintaining the position and / or orientation of the positioning tool (200) during the site-specific fractionated radiation therapy; (e) removing the steering guide (300) from the placement tool (200); and (f) repeating steps (a) through (e) for one or more subsequent portions of the site-specific fractionated radiation therapy.

[0223] Also provided herein is a method of treating a subject's body tissue that is a target for radiation therapy treatment using site-specific fractionated radiation therapy, comprising: (a) determining: o The position and / or orientation of the inserter (204) placed within the canal, and / or o the position and / or orientation of the effector shaft (310) of the steering guide (300) located within the elongate member lumen (214) of the inserter (204); The position and / or orientation of the inserter (204) or effector shaft (310) is determined from: one or more transponders (260, a, b, c) attached to the inserter (204), and / or one or more transponders (352, a, b, c) attached to the steering guide (204), and / or one or more optically detectable landmarks (346, i-iv) attached to the steering guide (300); (b) compared to the reference position of the inserter (204) and / or effector shaft (310) determined during the simulation procedure. the position and / or orientation of the inserter (204), and / or outputting a real-time indication of the position and / or orientation of the effector shaft (310) to a computer graphical user interface; (c) manually adjusting the position and / or orientation of the inserter (204) and / or effector shaft (310) until it coincides with the reference position of the inserter (204) and / or effector shaft (310); (d) maintaining the position and / or orientation of the inserter (204) during the site-specific fractionated radiation therapy; (e) removing the steering guide (300); (f) repeating steps (a) through (e) for one or more subsequent portions of the site-specific fractionated radiation therapy.

Claims

1. 1. A positioning tool (200) for assisting in the treatment of a subject in an external radiation therapy program including one or more external radiation therapy treatment sessions, comprising: an inserter (204) having a proximal end (40) and a distal end (20), said inserter comprising: an elongate member (210) configured to be inserted through an entrance into a tube (602) connected to the subject's body tissue (610), the elongate member (210) having an elongate member lumen (214) configured to receive an effector shaft (310) of a steering guide (300); a guide strand (218) for guiding the effector shaft (310) from outside the inlet of the tube into the lumen (214), the guide strand (218) being at least partially disposed within the lumen (214) and constrained at or toward the distal end (20) of the guide strand (218) to limit or prevent sliding of the guide strand (218) in a proximal direction relative to the lumen (214); The placement tool further comprises: A removable steering guide (300) having a proximal end (40) and a distal end (20), said steering guide comprising: an effector shaft (310) disposed at the distal end (20) configured for repeated, removable insertion into the elongate member lumen (214) along the guide strand (218); a handle portion (316) disposed at the proximal end (40) in fixed relationship to the effector shaft (310) for controlling the position and / or orientation of the effector shaft (310); the effector shaft (310) includes a body having a guide strand passage (312) for slidable movement along the guide strand (218), the guide strand passage (312) extending at least partially along the length of the body; The placement tool (200) is configured to move and / or fixate the vessel (602) and the body tissue (610) of the subject for the external radiation therapy treatment session.

2. 2. The placement tool (200) of claim 1, wherein the canal is the cervix and / or uterus and / or vaginal vault of the subject, the body tissue is tissue contained in the pelvic region of the subject, and the entrance to the canal is the entrance to a canal within the cervix or vaginal vault.

3. 3. The placement tool (200) of claim 1 or 2, wherein the elongated member (210) is provided with at least one sliding limiter (220) configured to reduce or prevent sliding of the elongated member (210) relative to the tube.

4. 4. The placement tool (200) of claim 3, wherein at least one sliding limiter (220) is an inflatable balloon assembly (230) including one or more inflatable balloons (231, -a to -h), or an expandable stent (240), a distal protrusion (245), or a stop member (250).

5. 5. The placement tool (200) of claim 4, wherein the inflatable balloon assembly (230) includes one or more inflatable balloons (231, -a through -h), each having an inflatable balloon lumen (232) fluidly connected to an inflation lumen (234) extending proximally (40) via an inflation tube (236).

6. The placement tool (200) of claim 5, wherein the guide strand (218) is the inflation tube (236).

7. At least two sliding limiters (220), namely a first sliding limiter provided at the proximal end (40) of the elongated member (210) and including a stop member (250) configured to abut an inlet of the tube, optionally the stop member (250) being provided with one or more suture channels (252) for suturing the inlet of the tube; the inflatable balloon assembly (230); or the distal projection (245), or the expandable stent (240), a second sliding limiter provided at the distal end (20) of the elongated member (210); The placement tool (200) of any one of claims 4 to 6, wherein:

8. The placement tool (200) of any one of claims 1 to 7, wherein the guide strand (218) is permanently or removably attached to the lumen (214).

9. The placement tool (200) of any one of claims 1 to 8, wherein the guide strand (218) is a relaxed tube (237) configured to receive a stiffening stylet.

10. at least a part of said inserter (204), or one or more imaging markers carried thereby, is visible by medical imaging, in particular X-ray medical imaging and / or MR medical imaging, and / or at least a portion of said elongate member (210), or one or more imaging markers carried thereby, is visible by medical imaging, in particular X-ray medical imaging and / or MR medical imaging; and / or The inserter (204) or elongate member (210) is equipped with one or more wireless transponders for determining the position and / or orientation of the inserter (204) and / or elongate member (210) in real time by a spatial transponder detector; or The placement tool (200) of any one of claims 1 to 9, wherein the elongated member (210) is not visible in an X-ray image.

11. The placement tool (200) of any one of claims 1 to 10, wherein the guide strand passage (312) is a groove or lumen in the effector shaft (310).

12. 12. The placement tool (200) of claim 1, wherein the effector shaft (310) body is rigid and the elongated member (210) is flexible and is stiffened by insertion into the elongated member lumen (214) of the effector shaft (310).

13. A placement tool (200) as described in any one of claims 1 to 12, wherein at least a portion of the effector shaft (310) and / or one or more imaging markers carried by the effector shaft (310) are visible by medical imaging, in particular X-ray medical imaging and / or magnetic resonance, MR medical imaging.

14. The removable steering guide (300) further comprises: a transmission (314) coupling said handle portion (316) to said effector shaft (310); Optionally, an inflatable transmission balloon (322) provided towards the distal end (20) of said transmission (314); Optionally, said inflatable transmission balloon (322) has a fixed maximum inflated diameter; and / or Optionally, said inflatable transmission balloon (322) carries one or more imaging markers that are visible by medical imaging; and / or Optionally, said inflatable transmission balloon (322) carries one or more wireless transponders for determining the position and / or orientation of said transmission (314) and / or said effector shaft (310) in real time by a spatial transponder detector; Optionally, the transponder receives power inductively or from an internal power source.

15. The one or more imaging markers carried by at least a distal portion of the transmission (314) and / or the effector shaft (310) are visible by medical imaging, in particular X-ray medical imaging or MR medical imaging; and / or 15. The placement tool (200) of claim 14, wherein the transmission (314) and / or the effector shaft (310) are positioned with one or more wireless transponders for determining the position and / or orientation of the transmission (314) and / or the effector shaft (310) in real time by a spatial transponder detector.

16. The movement of the tube (602) by the placement tool (200) comprises: directing the body tissue (608) connected to the tube (602) into the ionizing radiation beam emitted by the ionizing radiation treatment head (518) during the external radiation therapy treatment session; or 16. The placement tool (200) of claim 1, wherein the placement tool (200) moves body tissue (608) connected to the tube (602) away from an ionizing radiation beam emitted by an ionizing radiation treatment head (518) during the external radiation therapy treatment session.

17. The handle portion (316) is configured to be attached to a positioning device, the positioning device being configured to adjust and fix the position and / or orientation of the effector shaft (310); Optionally, 17. The placement tool (200) of any one of claims 1 to 16, wherein the handle portion (316) is provided with a grip locator (330) configured to cooperate with an end effector attachment of the placement device for removable, repeatable, and reproducible attachment of the handle portion (316) to the placement device.

18. A placement tool (200) as described in claim 17, wherein the handle portion (316) of the steering guide (300) is arranged with a docking beacon (340) configured to provide real-time information regarding the position and optionally the orientation of the steering guide (300), enabling manual, semi-automatic or automatic docking guidance between the placement device and the handle portion (316).

19. An arrangement tool (200) as described in claim 18, wherein the docking beacon is removable from the handle portion (316) or is non-removable from the handle portion (316).

20. A placement tool (200) as described in claim 18, wherein the docking beacon is an active docking beacon that wirelessly transmits information that enables the position and / or orientation of the handle portion (316) to be determined.

21. A placement tool (200) as described in claim 20, wherein the active docking beacon is an array of position-determining radio transponders.

22. A placement tool (200) as described in claim 21, wherein the transponder receives power inductively or from an internal power source.

23. A placement tool (200) as described in any one of claims 17 to 22, wherein the placement device is a robotic arm.

24. A placement tool (200) according to any one of claims 17 to 23; - the placement device as specified in claim 17 or 18 for adjusting and fixing the position and / or orientation of the handle portion (316) and the effector shaft (310) of the placement tool (200); Including, the handle portion (316) is configured to be removably attached to the placement device; The system wherein the placement device is a robotic arm.

Images