Device for reproducible body tissue alignment in extracorporeal radiotherapy treatment programs

Abstract

This provides placement tools to support the treatment of a target in an extracorporeal radiotherapy program that includes two or more extracorporeal radiotherapy treatment sessions. [Solution] A steering guide 330 is included, having a rigid handle portion 316 positioned at the proximal end in a fixed relationship with respect to the effector shaft 310, for controlling the position and / or direction of the effector shaft, the handle portion being provided with a grip locator 300 configured to cooperate in a positionally repeatable manner with a gripper of a robot arm, the gripper having an open state and a closed state. The grip locator is configured to be fixed within the gripper in the closed state, in which case the movement of the grip locator fixed to the gripper is restricted and prevented.

Description

[Technical Field]

[0001] Field of Invention The devices and methods of the present invention relate to the field of fractionated radiotherapy. In particular, the present invention relates to devices that can move and fix body tissue to an ionizing radiotherapy beam so that the position of the tissue is accurately reproduced in each session of an extracorporeal radiotherapy treatment program. [Background technology]

[0002] background Radiation therapy is the standard treatment for many patients with various cancers around the pelvic region. Most of the tissue structures surrounding 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 treatment with extracorporeal radiotherapy is administered, and optionally, to subsequent days that form the entire duration of the radiotherapy program. Such structural movement reduces the effectiveness of extracorporeal radiotherapy because the ionizing radiation may no longer align with the tumor target.

[0003] In most cases, extracorporeal radiotherapy is performed in fractions. This means that lower doses of radiation are delivered at frequent intervals (e.g., daily) to allow time for surrounding tissues to recover. Fractional treatment can last 6-7 weeks, and the movement of pelvic organs during this period is unpredictable. Our own research indicates that the cervix can move up to 2.2 cm in each direction, which requires introducing a large volume margin around the original treatment zone (i.e., cervical cancer), increasing the treatment volume and raising the incidence of acute and late side effects. Cervical movement between simulation and treatment, or between fractions, can be caused by filling or emptying the bladder and rectum, and partly by respiratory movements and bowel peristalsis. Therefore, patients are asked to empty their rectum and fill their bladder before each fraction. This can reduce uterine displacement, but it cannot prevent uterine displacement in a reproducible manner. In fact, as radiation therapy nears its end, inflammation of the bladder prevents complete filling, so patients often cannot maintain a consistent level of bladder fullness throughout the entire treatment period (e.g., 28-30 fractions). Furthermore, emptying the rectum causes both the anterior and posterior rectal walls to converge within the high-dose isodose volume surrounding the cervix, which has a treatment margin of 16-22 mm, so that the entire rectum is included within the high-dose volume.

[0004] In recent years, treatment techniques using conformal radiotherapy (multileaf collimators, 360° radiotherapy, CyberKnife, TomoTherapy) have made it possible to deliver very high doses locally while preserving healthy organs surrounding the tumor with great precision. These techniques offer the greatest benefits when the movement of the irradiation target is minimized. Nevertheless, they have not overcome the problem of tissue structure migration from simulation to treatment and / or between divided treatment sessions. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] Therefore, in order to reap the benefits of high treatment accuracy, it is necessary to create a system that can repeatedly fix the tissue structure of the pelvic region. [Means for solving the problem]

[0006] overview This specification provides a placement tool (200) for supporting the treatment of a subject in an extracorporeal radiotherapy program that includes two or more extracorporeal radiotherapy treatment sessions, - Includes a steering guide (300) having a proximal end (40) and a distal end (20), the steering guide is - A rigid effector shaft (310) at the distal end (20) configured to be inserted into the tube (602) of the object (50), or to be attached to an inserter (204) configured to be inserted into the tube (602) of the object (50), - Includes a rigid handle portion (316) positioned at the proximal end (40) in a fixed relationship with respect to the effector shaft (310) in order to control the position and / or direction of the effector shaft (310), - The placement tool (200) is configured to move and / or secure the tube (602) and body tissue (610) for an extracorporeal radiotherapy treatment session. - The handle portion (316) is provided with a grip locator (300) configured to cooperate with the gripper (432) of the robot arm (400) in a positionally repeatable manner, and the gripper (432) has an open state and a closed state. A placement tool (200) is provided, configured to be fixed within the gripper (432) in a closed state, in which case the movement of the fixed grip locator (300) relative to the gripper (432) is restricted and prevented.

[0007] The grip locator (300) may have a pair of arms, which are further apart when open than when closed.

[0008] The grip locator (300) may include one or more movement limiters configured to cooperate with one or more complementary movement limiter members of the closed gripper (432). This restricts and prevents the movement of the grip locator (300) fixed to the gripper (432).

[0009] The grip locator (300) may include one or more stopping members configured to cooperate with one or more complementary stopping members of a closed gripper (432).

[0010] The grip locator (300) may have one or more notches (334) and / or one or more protrusions and / or one or more corners (332) configured to cooperate with one or more complementary structures of a closed gripper.

[0011] The grip locator (300) may comprise one or more notches (334), each having a direction, and the edges of the notches may optionally be chamfered. The grip locator (300) may comprise one or more corners (332) positioned along the axial direction of the proximal end of the handle portion (316). The grip locator (300) may comprise at least one notch (334) and at least one corner (332), the at least one notch (334) and at least one corner (332) having different relative directions, preferably perpendicular. At least one notch may be provided within the longitudinal range of the corner.

[0012] moreover: - The placement tool (200) described herein, - A system is provided comprising a robot arm (400), wherein a closed gripper (432) is configured as a rotation and / or movement limiter that restricts and prevents the rotation and / or movement of a grip locator (300) fixed within the gripper (432) relative to the gripper (432).

[0013] Furthermore, a placement tool (200) for supporting the treatment of a target in an extracorporeal radiotherapy program that includes two or more extracorporeal radiotherapy treatment sessions, The steering guide (300) includes a proximal end (40) and a distal end (20), and the steering guide is - A rigid effector shaft (310) at the distal end (20) configured to be inserted into the tube (602) of the object (50) or to be attached to an inserter (204) configured to be inserted into the tube (602) of the object (50), - Includes a rigid handle portion (316) positioned at the proximal end (40) in a fixed relationship with respect to the effector shaft (310) and configured to connect to the end effector mounting fixture (430) of the robot arm (400) in order to control the position and / or direction of the effector shaft (310), - The placement tool (200) is configured to move and / or secure the tube (602) and body tissue (610) for an extracorporeal radiotherapy treatment session. - A placement tool (200) is provided, the handle portion (316) of which is provided with a docking beacon (340) configured to provide information regarding the position and optionally the direction of the steering guide (300) relative to the end effector mounting fixture (430) of the robot arm (400).

[0014] The docking beacon may include a passive docking beacon having a body of a predetermined geometric shape that is recognizable by the robotic arm's visual guidance system. The docking beacon may also include multiple spheres.

[0015] The docking beacon may include an active docking beacon configured to wirelessly emit information that allows for the determination of the position and / or orientation of the handle portion (316). The docking beacon may also include a solid-state gyroscope.

[0016] moreover: - The placement tool (200) described in this specification, - A robot arm (400) arranged together with an end effector attachment (430), and - A processing unit (440) including at least one processor and memory and configured to control the movement of the robot arm (400), where - When the end effector (430) approaches the handle portion (316), the processing unit (440) uses the information to adjust the posture of the end effector (430) in real time and couples the end effector attachment (430) to the handle portion (316) without changing the posture of the steering guide (300) already inserted into the target tube.

[0017] The handle portion (316) may be provided with the grip locator (300) described in this specification, and the end effector attachment (430) may be the gripper (432) described in this specification.

[0018] Furthermore, a placement tool (200) for assisting in the treatment of a target in an external beam radiotherapy program including two or more external beam radiotherapy treatment sessions, - including a steering guide (300) having a proximal end (40) and a distal end (20), the steering guide - is a rigid effector shaft (310) disposed at the distal end (20), - is inserted through an inlet to a tube (602) connected to a target body tissue (610), or - is repeatedly removably inserted into the elongate member lumen (214) of the elongate member (210) of an inserter (204) having a proximal end (40) and a distal end (20), the elongate member (210) being configured to be inserted through an inlet to a tube (602) connected to a target body tissue (610), the rigid effector shaft (310), - Includes a rigid handle portion (316) positioned at the proximal end (40) in a fixed relationship with respect to the effector shaft (310) in order to control the position and / or direction of the effector shaft (310), - The placement tool (200) is configured to move and / or secure the tube (602) and body tissue (610) for an extracorporeal radiotherapy treatment session. - The steering guide (300) is provided with an image acquisition system (360) configured to capture an image from the distal end (361) of the effector shaft (310), and a positioning tool (200) is provided to allow the effector shaft (310) to be inserted into the inlet of the tube (602) or the lumen (214) of the elongated member under the guidance of the captured image.

[0019] The distal end (361) of the effector shaft (310) may be positioned with an image inlet port (364) through which reflected light enters. The distal end (361) of the effector shaft (310) may also be positioned with one or more light outlet ports (362) through which light emitted by a light source exits. The positioning tool (200) may further comprise an inserter (204).

[0020] moreover: - A placement tool (200) as described herein, wherein the handle portion (316) of the placement tool (200) is provided with a grip locator (300) as described herein, - Including a robotic arm (400) described herein arranged together with an end effector mounting fixture (430), A system is provided in which a docking beacon (340) as described herein may be provided on the handle portion (316).

[0021] This specification provides for a placement tool (200) for supporting the treatment of a subject in an extracorporeal radiotherapy program comprising one or more extracorporeal radiotherapy treatment sessions, - Includes an inserter (204) having a proximal end (40) and a distal end (20), the inserter is - Includes an elongated member (210) configured to connect to the body tissue of the subject (610) and be inserted into the tube (602) through the entrance of the tube (602), The placement tool is further enhanced. - Includes a steering guide (300) having a proximal end (40) and a distal end (20), the steering guide is - An effector shaft (310) at the distal end (20) attached to or attachable to the elongated member (210), - Includes a handle portion (316) positioned at the proximal end (40) in a fixed relationship with respect to the effector shaft (310) in order to control the position and / or direction of the effector shaft (310), A placement tool (200) is provided, configured to move and / or fix a target tube (602) and body tissue (610) to an ionizing radiation therapy beam for an extracorporeal radiotherapy treatment session.

[0022] The elongated member (210) has an effector shaft (31) of the steering guide (300). An elongated member lumen (214) configured to accept 0) may be provided, - The effector shaft (310) may be configured for repeated, removable insertion into the elongated member lumen (214).

[0023] The steering guide (300) may further include a transmission (314) that connects the steering wheel portion (316) to the effector shaft (310).

[0024] The steering guide (300) is provided toward the distal end (20) of the transmission (314) and may further comprise an inflatable transmission balloon (322) having a fixed maximum expansion diameter.

[0025] At least a portion of the effector shaft (310) and / or one or more imaging markers supported thereby may be visualized by medical imaging, particularly X-ray medical imaging and / or magnetic resonance, MR, medical imaging. and / or - At least the distal portion of the transmission (314) and / or one or more imaging markers carried thereby may be visualized by medical imaging, in particular by X-ray medical imaging or MR medical imaging. and / or - The transmission (314) and / or effector shaft (310) may be accompanied by one or more radio transponders to determine the position and / or orientation of the transmission (314) and / or effector shaft (310) in real time by a spatial transponder detector.

[0026] At least a portion of the inserter (204), or one or more imaging markers supported thereby, may be visualized by medical imaging, particularly X-ray medical imaging and / or MR medical imaging. and / or - At least a portion of the elongated member (210), or one or more imaging markers supported thereon, can be seen by medical imaging, in particular by X-ray medical imaging and / or MR medical imaging, and / or - The inserter (204) and / or elongated member (210) may be accompanied by one or more wireless transponders to determine the position and / or orientation of the inserter (204) and / or elongated member (210) in real time by a spatial transponder detector, or - The elongated member (210) cannot be seen in X-ray imaging. and / or - At least a portion of the effector shaft (310) and / or one or more imaging markers supported thereby may be visualized by medical imaging, particularly X-ray medical imaging and / or magnetic resonance, MR, medical imaging. and / or - At least the distal portion of the transmission (314) and / or one or more imaging markers carried thereby may be visualized by medical imaging, in particular by X-ray medical imaging or MR medical imaging. and / or - The transmission (314) and / or effector shaft (310) may be arranged with one or more radio transponders to determine the position and / or orientation of the transmission (314) and / or effector shaft (310) in real time by a spatial transponder detector.

[0027] The handle portion (316) may be configured to be attached to a placement device, which is configured to adjust and / or fix the position and / or orientation of the effector shaft (310).

[0028] The handle portion (316) may be provided with a grip locator (330) configured to cooperate with an end effector mounting fixture of the placement device, the grip locator being configured to attach the handle portion (316) to the placement device in a removable, repeatable, and reproducible manner.

[0029] A docking beacon (340) configured to provide real-time information regarding the position and, optionally, the direction of the steering guide (300) may be placed together with the handle portion (316) of the steering guide (300), enabling manual, semi-automatic, or automatic docking guidance between the placement device and the handle portion (316).

[0030] The steering guide (300) may be provided with an image acquisition system (360) configured to acquire an image from the distal tip (361) of the effector shaft (310), enabling the effector shaft (310) to be inserted into the elongated member lumen (214) of the inserter (204) under the guidance of the acquired image.

[0031] The elongated member (210) may be flexible and is hardened by being inserted into the lumen (214) of the elongated member of the effector shaft (310).

[0032] The elongated member (210) may be provided with at least one sliding limiter (220) configured to reduce or prevent sliding of the elongated member (210) relative to the pipe. Optionally, at least one sliding limiter (220) is an inflatable balloon assembly (230) comprising one or more inflatable balloons (231, -a to -i), or an expandable stent (240), distal projection (245), or stopping member (250), Optionally, at least two sliding limiters (220), the first sliding limiter comprising a stop member (250) provided at the proximal end (40) of an elongated member (210) and configured to abut against the inlet of the pipe, and the second sliding limiter comprising an inflatable balloon assembly (230), a distal projection (245), or an expandable stent (240) provided at the distal end (20) of an elongated member (210), Optionally, at least one sliding limiter (220) is a stopper (250) positioned at the proximal end (40) of an elongated member (210) and configured to abut against the inlet of the pipe. Optionally, the stopping member (250) is provided with one or more suture channels (252) for suturing the entrance of the tube. Optionally, the inflatable balloon assembly (230) comprises one or more inflatable balloons (231, -a to -i), each having an inflatable balloon lumen (232) fluidly connected to an expansion lumen (234) extending proximal (40) via an expansion tube (236).

[0033] The inserter (204) is, - The effector shaft (310) may be further provided with a guide strand (218) for guiding it into the lumen (214) from outside the inlet of the tube, the guide strand (218) being positioned at least partially within the lumen (214) and being constrained toward its distal end (20) or toward its distal end (20) to restrict or prevent the sliding of the guide strand (218) in the proximal direction relative to the lumen (214). - Optionally, the effector shaft (310) can be connected to the guide strand (218). The body comprises a guide strand passage (312) provided for sliding along the length of the body, the guide strand passage (312) provided at least partially along the length of the body, and / or - Optionally, the guide strand passage (312) is a groove or lumen of the rigid effector shaft (310), and / or - Optionally, the guide strand (218) is either a cord or an expansion tube (236). - Optionally, the guide strand (218) may be attached to the lumen (214) in a non-removable or removable manner. or - The system may further include a guide sleeve (238) having a sleeve lumen (239) for guiding the effector shaft (310) into the elongated member lumen (214) from outside the inlet of the tube, the distal end (20) of the Geistland (218) being fixedly attached to the elongated member lumen (214), and the guide sleeve lumen being configured to receive the steering guide effector shaft (310) and guide the steering guide effector shaft (310) into the elongated member lumen (214), and - Optionally, the effector shaft (310) is equipped with a body for slidable movement within the guide sleeve lumen.

[0034] The duct may be the cervix, uterus, vaginal fornix, vagina, or vaginal recurrence site. The movement of the pipe (602) using the placement tool (200) is as follows: - During an extracorporeal radiotherapy treatment session, body tissue (608) connected to a tube (602) is irradiated with an ionizing radiation beam emitted by an ionizing radiation therapy head (518). or - During an extracorporeal radiotherapy treatment session, it is possible to keep body tissue (608) connected to the tube (602) away from the ionizing radiation beam emitted by the ionizing radiation therapy head (518).

[0035] moreover: - Placement tools as described herein, - A system is provided which includes a placement device configured to adjust and fix the position and / or orientation of the effector shaft (310).

[0036] The placement device may include an end effector mount configured for precise, repeatable, and removable attachment to the handle portion (316). The placement device may also include a robotic arm having at least three degrees of freedom of motion for the end effector mount. [Brief explanation of the drawing]

[0037] [Figure 1] An isometric view of the inserter provided herein is shown. [Figure 2A] A longitudinal section view of the inserter provided herein, which is positioned with guide strands for detachable attachment to a steering guide, is shown. [Figure 2B] A longitudinal cross-sectional view of an inserter that is detachably attached to the steering guide is shown. [Figure 2C] The diagram shows a longitudinal section of an inserter provided herein, which is arranged with a removable guide strand equipped with a ball stop section, and the inserter is provided to be removablely attached to a steering guide. [Figure 2D]A longitudinal section view of an inserter provided herein is shown, which is arranged with a removable guide strand having a threaded distal end, and the inserter is provided to be removablely attached to a steering guide. [Figure 2E] Figure 2D shows a removable guide strand with a threaded distal end. [Figure 3A] This shows the different elements of the inserter that can be combined. [Figure 3B] This shows the different elements of the inserter that can be combined. [Figure 3C] This shows the different elements of the inserter that can be combined. [Figure 3D] This shows the different elements of the inserter that can be combined. [Figure 3a] This shows the different elements of the inserter that can be combined. [Figure 3b] This shows the different elements of the inserter that can be combined. [Figure 3c] This shows the different elements of the inserter that can be combined. [Figure 3i] This shows the different elements of the inserter that can be combined. [Figure 3ii] This shows the different elements of the inserter that can be combined. [Figure 3iii] This shows the different elements of the inserter that can be combined. [Figure 3iv] This shows the different elements of the inserter that can be combined. [Figure 3v] This shows the different elements of the inserter that can be combined. [Figure 3E] This shows the different elements of the inserter that can be combined. [Figure 3F] This shows the different elements of the inserter that can be combined. [Figure 3d] This shows the different elements of the inserter that can be combined. [Figure 3e] This shows the different elements of the inserter that can be combined. [Figure 3f] This shows the different elements of the inserter that can be combined. [Figure 3vi] This shows the different elements of the inserter that can be combined. [Figure 3vii] This shows the different elements of the inserter that can be combined. [Figure 3viii] This shows the different elements of the inserter that can be combined. [Figure 3ix] This shows the different elements of the inserter that can be combined. [Figure 3x] This shows the different elements of the inserter that can be combined. [Figure 3G] This shows the different elements of the inserter that can be combined. [Figure 3H] This shows the different elements of the inserter that can be combined. [Figure 3J] This shows the different elements of the inserter that can be combined. [Figure 3K] This shows the different elements of the inserter that can be combined. [Figure 3g] This shows the different elements of the inserter that can be combined. [Figure 3h] This shows the different elements of the inserter that can be combined. [Figure 3j] This shows the different elements of the inserter that can be combined. [Figure 3xi] This shows the different elements of the inserter that can be combined. [Figure 3xii] This shows the different elements of the inserter that can be combined. [Figure 3xiii] This shows the different elements of the inserter that can be combined. [Figure 3xiv] This shows the different elements of the inserter that can be combined. [Figure 3xv] This shows the different elements of the inserter that can be combined. [Figure 3L] This shows the different elements of the inserter that can be combined. [Figure 3M] This shows the different elements of the inserter that can be combined. [Figure 3N] This shows the different elements of the inserter that can be combined. [Figure 3k] This shows the different elements of the inserter that can be combined. [Figure 3l] This shows the different elements of the inserter that can be combined. [Figure 3m] This shows the different elements of the inserter that can be combined. [Figure 3O]This shows the different elements of the inserter that can be combined. [Figure 3P] This shows the different elements of the inserter that can be combined. [Figure 3n] This shows the different elements of the inserter that can be combined. [Figure 3o] This shows the different elements of the inserter that can be combined. [Figure 3p] This shows the different elements of the inserter that can be combined. [Figure 3xvi] This shows the different elements of the inserter that can be combined. [Figure 3xvii] This shows the different elements of the inserter that can be combined. [Figure 3xviii] This shows the different elements of the inserter that can be combined. [Figure 3xix] This shows the different elements of the inserter that can be combined. [Figure 3xx] This shows the different elements of the inserter that can be combined. [Figure 3Q] This shows the different elements of the inserter that can be combined. [Figure 3R] This shows the different elements of the inserter that can be combined. [Figure 3S] This shows the different elements of the inserter that can be combined. [Figure 3T] This shows the different elements of the inserter that can be combined. [Figure 3q] This shows the different elements of the inserter that can be combined. [Figure 3r] This shows the different elements of the inserter that can be combined. [Figure 3s] This shows the different elements of the inserter that can be combined. [Figure 3xxi] This shows the different elements of the inserter that can be combined. [Figure 3xxii] This shows the different elements of the inserter that can be combined. [Figure 3xxiii] This shows the different elements of the inserter that can be combined. [Figure 3xxiv] This shows the different elements of the inserter that can be combined. [Figure 3xxv]The following describes different elements of a combinatorial inserter, including an elongated member (A-D), a proximal sliding restrictor (a-b) or none (c), and a distal sliding restrictor (i-v). The guide strand is a flexible cord, with an elongated member (E-F), a proximal sliding restrictor (d-e) or none (f), a distal sliding restrictor (vi-x), and the guide strand is detachably attached to the elongated member; an elongated member (G-K), a proximal sliding restrictor (g-j), a distal sliding restrictor (xi-xv), and no guide strand; an elongated member (L-N), a proximal sliding restrictor (k-m), and the guide strand is an expandable tube; an elongated member (O-P), a proximal sliding restrictor (n-o) or none (p), and a distal sliding restrictor (xvi-x), and the guide strand is detachably attached to the elongated member. [Figure 4] This shows a magnified view of the expansion tube (236) inside the expansion lumen (234). [Figure 5-1] Figure 5 shows the placement tool (200) described herein, equipped with an inserter (204), together with a guide strand (218) which is a flexible cord (219) and a steering guide (300), with the inserter located inside the cervix. [Figure 5-2] Figure 5' is the same as Figure 5, except that the inserter (204) does not have a guide strand. [Figure 6-1] Figure 6 shows an exemplary steering guide provided herein, with optional alternative arrangements for guide strand passage exits and optional alternative arrangements for balloons. [Figure 6-2] Figure 6' is the same as Figure 6, except that the steering guide does not have a guide strand passage. [Figure 6A] Figures 6 and 6' show the angle gamma as seen along the line of sight (E). [Figure 7] Each shows a steering guide configuration with an integrated polymer handle and transmission, and each has a different configuration of the guide strand passage outlet of the steering guide. [Figure 8-1]Figure 8 shows the configurations of a steering guide with an integrated polymer handle and a transmission, respectively, each having a different configuration of the guide strand passage exit of the steering guide. [Figure 8-2] Figure 8' is similar to Figures 7 and 8, except that the tearing guide is provided without a guide strand passage. [Figure 9-1] Figure 9 shows a steering guide equipped with an inflatable transmission balloon and having guide strand passages. [Figure 9-2] Figure 9' shows the steering guide of Figure 9 without the guide strand passage. [Figure 10] The guide strand passage indicates a steering guide that is a slot. Details of the entrance to the slot are shown in Figure 10A. [Figure 11] An alternative configuration for the steering guide handle portion (316) notch is shown. [Figure 12] An alternative configuration for the steering guide handle portion (316) notch is shown. [Figure 13] An alternative configuration for the steering guide handle portion (316) notch is shown. [Figure 14] An alternative configuration for the steering guide handle portion (316) notch is shown. [Figure 15-1] Figure 15 shows a steering guide configuration having a steering guide passage (Figure 15) or a steering guide without a guide strand passage, having an integrated polymer handle and transmission (Figure 15'), and having a handle portion (316) including notches and corners. [Figure 15-2] Figure 15' shows a steering guide configuration having a steering guide passage (Figure 15) or a steering guide without a guide strand passage (Figure 15') having an integrated polymer handle and transmission, with a handle portion (316) including notches and corners. [Figure 15A]Figure 15 shows a steering guide configuration having a steering guide passage (Figure 15) or a steering guide without a guide strand passage, having an integrated polymer handle and transmission (Figure 15'), and having a handle portion (316) including notches and corners. [Figure 15B] Figure 15 shows a steering guide configuration having a steering guide passage (Figure 15) or a steering guide without a guide strand passage, having an integrated polymer handle and transmission (Figure 15'), and having a handle portion (316) including notches and corners. [Figure 15C] Figure 15 shows a steering guide configuration having a steering guide passage (Figure 15) or a steering guide without a guide strand passage, having an integrated polymer handle and transmission (Figure 15'), and having a handle portion (316) including notches and corners. [Figure 16] The steering guide configuration is similar to that shown in Figure 15 or Figure 15', and a transmission balloon is also provided. [Figure 17-1] Figure 17 is a longitudinal cross-sectional view of the steering guide in Figure 16, where a guide strand passage is provided in the steering guide. [Figure 17-2] Figure 17' shows a longitudinal cross-sectional view of the steering guide in Figure 16, where the steering guide is provided without a guide strand passage. [Figure 18] Figure 17 shows a magnified view of the lumen. [Figure 19] This shows steering guides, each equipped with a different docking beacon. [Figure 20] This shows steering guides, each equipped with a different docking beacon. [Figure 21] This shows steering guides, each equipped with a different docking beacon. [Figure 22-1]Figure 22 shows different inserters positioned within the cervix. In Figures 22 and 23, the inserter is equipped with a guide strand, which is a flexible cord, while in Figures 24 and 25, the inserter is equipped with a guide strand, which is an expansion tube. [Figure 23-1] Figure 23 shows different inserters positioned within the cervix. In Figures 22 and 23, the inserter is equipped with a guide strand, which is a flexible cord, while in Figures 24 and 25, the inserter is equipped with a guide strand, which is an expansion tube. [Figure 24-1] Figure 24 shows different inserters positioned within the cervix. In Figures 22 and 23, the inserter is equipped with a guide strand, which is a flexible cord, while in Figures 24 and 25, the inserter is equipped with a guide strand, which is an expansion tube. [Figure 25-1] Figure 25 shows different inserters positioned within the cervix. In Figures 22 and 23, the inserter is equipped with a guide strand, which is a flexible cord, while in Figures 24 and 25, the inserter is equipped with a guide strand, which is an expansion tube. [Figure 22-2] Figure 22' is similar to Figures 22 through 25, except that the inserter does not have a guide strand. In Figures 22' to 25', the distal sliding limiter is inflated by a laterally positioned expansion tube. [Figure 23-2] Figure 23' is similar to Figures 22 to 25, except that the inserter does not have a guide strand. In Figures 22' to 25', the distal sliding limiter is inflated by a laterally positioned expansion tube. [Figure 24-2] Figure 24' is similar to Figures 22 to 25, except that the inserter does not have a guide strand. In Figures 22' to 25', the distal sliding limiter is inflated by a laterally positioned expansion tube. [Figure 25-2]Figure 25' is similar to Figures 22 through 25, except that the inserter does not have a guide strand. In Figures 22' through 25', the distal sliding limiter is inflated by a laterally positioned expansion tube. [Figure 26-1] Figure 26 shows a placement tool comprising an inserter provided herein, positioned within the cervical canal and mounted on a steering guide, and the movement of the steering guide to change the position of the cervix and uterus. The inserter is provided with a guide strand, which is an expansion tube. [Figure 26-2] Figure 26' is similar to Figure 23, except that the inserter does not have a guide strand. [Figure 27] This shows an inserter equipped with a guide sleeve. [Figure 28] This diagram shows a placement tool inserted into a tube, and the position of the body tissue changes depending on the different orientations of the placement tool (A and B). [Figure 29] This diagram shows a placement tool inserted into a tube, and the position of the body tissue changes depending on the different orientations of the placement tool (A and B). [Figure 30A] These are composite medical images showing changes in the positioning tool (insertor) posture recorded during the simulation, the treatment session, and before the start of exposure. [Figure 30B] Figures 30A and 30B show composite medical images illustrating changes in the position of the insertion tool (insertor) recorded during the simulation, treatment session, and before the start of exposure. Figure 30A is a side view of the insertion tool (insertor), and Figure 30B is an axial view of the insertion tool (insertor). [Figure 31] These dose-volume graphs show the dose / volume distribution received by the rectum, bladder, and cervical structures when the cervix is ​​not fixed (a, b, c, respectively) or when the cervix is ​​fixed (a', b', c'). [Figure 32]This is a diagram of a steering guide that has the function of capturing an image and providing illumination. Panel A shows the steering guide, panel B is a magnified view of the distal end of the effector shaft with an optical exit port and an image input port, and panel C shows an optional auxiliary unit housing electrical equipment, and optionally an image sensor, and optionally a light source. [Figure 33] This is a schematic diagram of a robotic arm that can be attached to a radiotherapy treatment table or simulation table. [Modes for carrying out the invention]

[0038] Detailed explanation Before describing the tools and methods of the present invention, it should be understood that such tools and methods and combinations may naturally vary, and therefore the present invention is not limited to the specific systems and methods or combinations described. Furthermore, it should be understood that the scope of the present invention is limited only by the appended claims, and therefore the terms used herein are not intended to be limiting.

[0039] As used herein, the singular forms "a," "an," and "the" refer to both singular and plural objects unless the context clearly indicates otherwise.

[0040] As used herein, the terms “contains,” “contains,” and “consist of” are used to mean “contains.” The terms "contains," "includes," and "consist of" are synonymous with "contains," "includes," and are comprehensive or unrestricted, and do not exclude any additional members, elements, or method steps not listed herein. As used herein, the terms "contains," "includes," and "consist of" shall be understood to include the terms "consist of," "consist of," and "consist of."

[0041] When specifying a numerical range using endpoints, the range should include not only the specified endpoints but also all numbers and fractions contained within that range.

[0042] When the terms “about” or “approximately” are used herein to refer to measurable values ​​such as parameters, quantities, or durations, they mean to include variations of ±10%, preferably ±5%, more preferably ±1%, and even more preferably ±0.1% from a specified value, and are appropriate to implement in the disclosed invention as long as such variations exist. It should be understood that the values ​​themselves to which the modifiers “about” or “approximately” refer are also to be specifically and preferably disclosed.

[0043] On the other hand, the terms “one or more” or “at least one,” such as one or more or at least one member of a group of members, are self-evident, but by further examples, the terms encompass references to any one of the members, or any two or more of the members, for example, any ≥3, ≥4, ≥5, ≥6, ≥7, etc., and at most all of the members.

[0044] All references cited herein are incorporated herein by reference in their entirety. In particular, the teachings of all references specifically referenced herein are incorporated by reference.

[0045] Unless otherwise specified, all terms used in the disclosure of this invention, including technical and scientific terms, have meanings that are generally understood by those skilled in the art to which this invention pertains. For further guidance, a definition of terms is provided to better understand the teachings of this invention.

[0046] The following text provides more detailed descriptions of various aspects of the present invention. Each of the aspects described herein can be combined with any other aspect unless otherwise explicitly stated. In particular, any feature indicated as preferred or advantageous can be combined with any other feature indicated as preferred or advantageous.

[0047] Throughout this specification, any reference to “one embodiment” or “embodiment” means that certain features, structures, or characteristics described in relation to an embodiment are included in at least one embodiment of the present invention. Thus, the phrases “in one embodiment” or “in a particular embodiment” appearing 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, certain features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. Furthermore, while some embodiments described herein include some features included in other embodiments, and others do not, as will be understood to those skilled in the art, combinations of features from different embodiments are within the scope of the present invention and form different embodiments. For example, in the appended claims, any of the claimed embodiments can be used in any combination.

[0048] The description of this invention refers to accompanying drawings that form part thereof, but these drawings are provided solely for the purpose of illustrating specific embodiments in which the invention can be carried out. Reference numerals in parentheses or bold attached to each element are merely illustrative of that element and do not limit each element. This is not a limitation. It should be understood that other embodiments may be used, or structural or logical modifications may be made, without departing from the scope of the present invention. Therefore, the following embodiments for carrying out the invention should not be construed as restrictive, and the scope of the invention is defined by the appended claims.

[0049] The terms “distal,” “distal side,” or “distal to,” and “proximal,” “proximal side,” or “proximal to,” are used throughout the specification and are generally understood in the art to mean moving toward (proximal to) or toward (distal to) the practitioner of the device. Thus, “proximal” means moving toward the practitioner and therefore away from the side of the object. Conversely, “distal” means moving toward the side of the object and therefore away from the side of the practitioner.

[0050] The term "longitudinal direction" is generally understood in this field to mean along the longer length of the treatment table or simulation table. This can be used to refer to the radiotherapy treatment table or simulation table itself, or devices that can be attached to the radiotherapy treatment table or simulation table, or the object lying on the radiotherapy treatment table or simulation table.

[0051] The term "lateral" is generally understood in this field to mean along the shorter length of the treatment table or simulation table, i.e., from side to side or left to right. This can be used to refer to the radiotherapy treatment table or simulation table itself, or a device that can be attached to the radiotherapy treatment table or simulation table, or an object lying on the radiotherapy treatment table or simulation table.

[0052] The term "upper" is understood to mean the head of the subject. This may be used to refer to a radiotherapy treatment table or simulation table, or a device that can be attached to a radiotherapy treatment table or simulation table, or a subject lying on a radiotherapy treatment table or simulation table. The term "lower" is understood to mean the feet of the subject. This may be used to refer to a radiotherapy treatment table or simulation table, or a device that can be attached to a radiotherapy treatment table or simulation table, or a subject lying on a radiotherapy treatment table or simulation table.

[0053] This specification provides placement tools for assisting the treatment of a subject for an extracorporeal radiotherapy program. An extracorporeal radiotherapy program includes at least one session or portion of an extracorporeal radiotherapy treatment and / or a simulation of the treatment. The placement tool (200) comprises an inserter (204) (e.g., Figures 1, 2A to 2D) having a proximal end (40) and a distal end (20). The inserter (204) comprises an elongated member (210) configured to be inserted through an inlet into a tube connected to body tissue. The elongated member (210) may be sized to engage with the wall of the tube so that the movement of the placement tool (200) causes the tube to move. The elongated member (210) is provided with an elongated member lumen (214) configured to receive an effector shaft (310) of a steering guide (300) (e.g., Figure 6). The effector shaft (310) may be configured to cooperate with the elongated member (210) so that the movement of the steering guide is transmitted to the elongated member (210).

[0054] The inserter (204) may be permanently (e.g., permanently) attached to the steering guide (e.g., Figure 2B). The elongated member lumen (214) of the inserter (204) may be configured to be repeatedly and detachably attached to the effector shaft (310) of the steering guide (300) (e.g., Figures 2A, 2B-2D). The effector shaft (310) is such that if the elongated member (210) is flexible, The inserter (204) may be further configured to harden at least a substantial portion. The inserter (204) may further comprise a guide strand (218) for guiding the effector shaft (310) into the lumen (214) from outside the inlet of the tube. The distal end (20) of the guide strand (218) is fixedly attached to the lumen (214).

[0055] The movement of the tube by the placement tool (200) causes movement of the target tissue with respect to the extracorporeal ionizing radiation therapy beam, particularly with respect to the beam crossing volume of the extracorporeal ionizing radiation therapy beam. The position and / or orientation (posture) of the placement tool can be adjusted and fixed for at least a portion of the treatment session, thereby stably fixing the position of the tissue relative to the ionizing radiation therapy beam. Figures 28 and 29 illustrate the present invention. The movement of the tube by the placement tool (200) can align the target tissue with the ionizing radiation therapy beam, for example, the ionizing radiation therapy isodose volume defined during patient simulation under a CT scan or MR. Alternatively, the movement of the tube by the placement tool (200) can move and / or fix the target tissue away from the ionizing radiation therapy beam, for example, to protect its structure.

[0056] Panel A of Figure 28 shows a placement tool (200) inserted into a target tube (602) and a body tissue (608) connected to the tube (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 with respect to the ionizing radiation beam emitted by the ionizing radiation head, particularly with respect to the beam crossing volume (612) (e.g., the isocenter). The beam crossing volume (612) has a constant position in Panels A and B. In the case of Panel B of Figure 28, the body tissue (608) is also a therapeutic target (610) brought into the beam crossing volume (612) for exposure to ionizing radiation. The orientation of the placement tool (200) can be recorded and reused in subsequent sessions of fractional therapy.

[0057] Panel A of Figure 29 shows a placement tool (200) inserted into a target tube (602) and a body tissue (608) connected to the tube (602). By adjusting the orientation of the placement tool (200) (Panel B of Figure 29), the position of the body tissue (608) can be stabilized, adjusted, and fixed with respect to the ionizing radiation beam emitted by the ionizing radiation head, particularly with respect to the beam crossing volume (612) (e.g., the isocenter). The beam crossing volume (612) has a constant position in Panels A and B. In the case of Panel B of Figure 29, the body tissue (608) is brought outside the beam crossing volume (612) to avoid exposure to ionizing radiation, rather than to the therapeutic target (610). The orientation of the placement tool (200) can be recorded and reused in subsequent sessions of fractional therapy.

[0058] Figures 30A and 30B show the degree of movement of the target organ or tissue between simulation and treatment, or between treatment sessions. Each figure is a fused X-ray image of a subject undergoing simulation and treatment of a cervical tumor, with the placement tool (200) inserter (204) described here inserted into the cervix. Images taken during the simulation are superimposed with the subsequent first treatment session. The external margin (614) of the irradiated volume is shown.

[0059] The first pose (A) of the placement tool (200) inserter (204) used in the simulation corresponded to the natural placement of tissues and organs, requiring minimal active pose adjustment by the robotic arm. The second pose (B) of the placement tool (200) inserter (204) was recorded in the subsequent first treatment session before adjustment by the robotic arm. There is a significant difference between the first pose (A) and the second pose (B), which is due to the internal movement of tissues and organs between sessions, causing the tip of the inserter (204) to displace by approximately 2.1 cm, and correspondingly shifting the position of the treatment target. The new pose (B) shows the outside of the irradiated volume. The gin was present and received a much lower dose than calculated. Internal movement is corrected by this system and method by adjusting the posture of the placement tool (200) inserter (204) by a robotic arm during the treatment session to correspond to the posture recorded during the simulation, leading to a significant reduction in toxicity.

[0060] Figure 31 shows the effect of the placement tool on reducing toxicity in adjacent structures. It is a dose-volume histogram chart showing the relationship between the proportion of the irradiated volume for each organ (rectum, bladder, cervix) and the dose received by the irradiated volume for the rectum (a, a'), bladder (b, b'), and cervix (c, c'). For extracorporeal radiotherapy treatment of the cervix, calculations were performed for cases where the cervix was not placed (natural position) (a, b, c) and when the cervix was placed using the placement tool (a', b', c'). When the cervix is ​​the treatment target, the rectum (a, a') and bladder (b, b') are affected by radiotoxicity. The margin in this calculation was 16 mm when the cervix was not placed (small margin) and 5 mm when the cervix was placed using the placement tool.

[0061] In the rectum (a, a'), if the cervix is ​​not positioned using a positioning tool, 50% of the rectal volume will be 50 Gy(a 50 ) received a dose of 50 Gy(a') when the cervix was positioned using a positioning tool. 50 ) was received. If the cervix is ​​not present, 30% of the rectal volume was 70 Gy(a 70 ) received a dose of 70 Gy(a') when the cervix was positioned using a positioning tool. 2.5% of the rectal volume was 70 Gy(a') 70 The patient received a dose of 50 Gy. Therefore, when the placement tool was placed on the cervix, the dose received by the rectum decreased from 50% to 13% (3.9 times reduction) at 50 Gy and from 30% to 2.5% (12 times reduction) at 70 Gy.

[0062] In the bladder (b, b'), if the cervix is ​​not located, 22% of the bladder volume is 50 Gy (b 50) received a dose of. When the cervical region is positioned using the positioning tool, 10% of the bladder volume received 50 Gy (b’ 50 ) received a dose of. When the cervical region is not positioned, 12% of the bladder volume received 70 Gy (b 70 ) received a dose of. When the cervical region is positioned using the positioning tool, 3% of the bladder volume received 70 Gy (b’ 70 ) received a dose of. Therefore, when the positioning tool is placed on the cervical region, the dose received by the bladder decreased from 22% to 10% (a difference of 2.2 times) at 50 Gy and from 12% to 3% (a four-fold decrease) at 70 Gy.

[0063] In the cervical region (c, c’), when the cervical region is not positioned, 100% of the cervical volume received 50 Gy (c 50 ) received a dose of. When the cervical region is positioned using the positioning tool, 100% of the cervical volume also received 50 Gy (c’ 50 ) received a dose of. When the cervical region is not positioned, approximately 98% of the cervical volume received 70 Gy (c 70 ) received a dose of. When the cervical region is positioned using the positioning tool, approximately 99.5% of the cervical volume received 70 Gy (c’ 70 ) received a dose of. Therefore, the positioning tool did not affect the volume / dose of the cervical region, and the volume of the cervical region receiving the higher 70 Gy dose increased slightly.

[0064] The results in Figure 31 demonstrate that high doses can be delivered to the cervix from the outside while reducing complications caused by rectal and bladder irradiation. Traditionally, such high doses had to be delivered by close-range radiotherapy (internal radiation source). Close-range radiotherapy is more targeted to internal structures but is more complex. The majority of cervical cancer patients are inoperable due to vaginal or parauterine invasion, requiring anesthesia and hospitalization, and necessitating the implantation of invasive structures using close-range radiotherapy needles. This is only feasible at a limited number of radiotherapy centers, and therefore not all patients can receive this treatment. This complex close-range radiotherapy intervention can be avoided by fixing and positioning the cervix using this placement tool (200). Fixing and positioning the cervix allows for increased dose to the cervix without causing excessive toxicity to surrounding tissues, thus reducing the need for close-range radiotherapy. .

[0065] The tube (602) can be precisely moved and / or fixed by a placement tool (200) to change and fix the position of the tube and body tissue relative to the extracorporeal ionizing radiation therapy beam. The body tissue may be located within the tube or it may be a structure that moves as the tube moves (e.g., the prostate gland moving with the rectal canal, or the uterus moving with the cervix). The target tube (602) is preferably a tube (passage) of a natural body structure, such as the cervix (602') and / or the uterus (604), vagina (606), or a tube created inside the vaginal fornix (tumor or recurrence of a tumor). In Figures 22–25, and Figures 22'–25', Figure 26', and Figure 26', the placement tool (200) is positioned inside the cervix (602'). The tube may be a surgically formed tube, for example, within the vaginal fornix or within a tissue mass such as the breast.

[0066] The body tissues (608) associated with the tube refer to the following tissues, which are movable by changing the spatial position and / or orientation of the tube, i.e., by changing the spatial position and / or orientation (posture) of the placement tool (200). In other words, the tube is movably connected to the body tissues. The body tissues may be part of the tube wall, or they may be different tissue structures whose position and / or orientation is affected by the movement of the tube. 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.

[0067] Body tissue (608) may be the target of treatment (610) (e.g., a tumor) and may be the tissue introduced into the extracorporeal ionizing radiation therapy beam for exposure to the beam. Thus, the target to be treated is positioned very precisely, allowing for maximum dose acceptance and reducing damage to healthy structures. Alternatively, body tissue may be the tissue moved out of the extracorporeal ionizing radiation therapy beam, thereby avoiding exposure to the beam. Thus, healthy tissue can be kept away from the target, allowing for more isolated exposure.

[0068] Body tissue (608) may be tissue of an organ or tissue of an organ. Body tissue may be tissue structures within the pelvic region that can be moved by changing the position and / or orientation of the cervix and / or uterus and / or vagina, such as the cervix, uterine body, rectum, bladder, and vagina. Body tissue may be tissue structures in the region surrounding the uterus and vagina, such as the rectum, lower colon, and bladder, that can be moved by changing the position and / or orientation of the uterus and vagina. It is understood that placement tools can be used to treat multiple tissues adjacent to a canal.

[0069] During simulation under medical imaging, the tube (602) can be precisely positioned or moved by the positioning tool (200) to align body tissue with the extracorporeal ionizing radiation therapy beam, particularly with respect to positional references, and the recorded position of the positioning tool (200) is used for subsequent treatment.

[0070] Radiation therapy is delivered to the subject while the tube is held in one or more treatment positions. These treatment positions can be replicated in one or more subsequent sessions. This system allows for the stabilization of body structures, which may change shape or position between sessions, by bringing them to a known, defined position during each session.

[0071] For example, if the cervix is ​​positioned in the same spatial location relative to the pelvic bone or the isocenter of the radiotherapy machine during each radiotherapy session, spontaneous movement of the cervix is ​​completely eliminated, and the volume irradiated around the cervix to account for spontaneous displacement of the cervix is ​​significantly reduced. As the cervix shrinks, the safety margin around the cervix can decrease from 2 cm to 3-4 mm.

[0072] The systems, placement tools, and methods described herein can be used to treat one or more tumors present in body tissue.

[0073] Typically, the ionizing radiation head moves so that different ionizing radiation beam directions intersect during a treatment session, thereby minimizing damage to surrounding tissue. The beam-crossing volume is the volume in which different ionizing radiation beam directions intersect during an extracorporeal radiotherapy treatment session. The simulated beam-crossing volume is the volume in which various simulated ionizing radiation beam directions intersect during a simulation of an extracorporeal radiotherapy treatment session. The (simulated) beam-crossing volume typically coincides with a tissue target within the subject (e.g., a tumor).

[0074] When a radiotherapy device (510) comprises an ionizing radiation therapy head (518) that rotates around a single axis, the beam crossing volume is also known as the isocenter, which is the rotational center of the ionizing radiation beam emitted by the ionizing radiation therapy head (518) during an extracorporeal radiotherapy 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 rotational center of the ionizing radiation beam emitted by the ionizing radiation therapy head (518) during a simulation of an extracorporeal radiotherapy treatment session.

[0075] In other systems (e.g., CyberKnife), the radiotherapy device (510) is equipped with an ionizing radiation therapy head (518) mounted on a robotic arm having three or more degrees of freedom of movement, thereby enabling directional control of the ionizing radiation beam around multiple axes. The beam crossing volume is the volume at which different directions of ionizing radiation beams emitted by the ionizing radiation therapy head (518) intersect during an extracorporeal radiotherapy treatment session. The simulated beam crossing volume is the volume at which different directions of ionizing radiation beams emitted by the ionizing radiation therapy head (518) intersect during a simulation of an extracorporeal radiotherapy treatment session.

[0076] An extracorporeal radiotherapy (EVA) treatment program refers to one or more sessions of radiation therapy delivered to the target treatment site by an EVA source (e.g., a linear accelerator or TomoTherapy system with optional multi-leaf collimators, or a CyberKnife system, which is an ionizing radiation source that moves around the patient). Treatment may consist of one or more sessions or fractions. If there are multiple fractions, the total dose is divided into several smaller doses delivered at intervals over time (fractions). Typically, the treatment period for cervical tumors is 28 to 32 fractions, with the tumor receiving a dose of up to 2.6 Gy in each fraction. Fractionated treatment gives healthy cells around the treatment site time to recover. This system can also be used to deliver treatment in several fractions as additional therapy or as palliative care in case of bleeding, for example, delivering a high dose in each fraction, such as 6 Gy five times or 4 Gy five times as additional therapy, or 7 Gy five times each as palliative care.

[0077] A radiotherapy program typically consists of a simulation phase and a treatment phase. The simulation phase precedes the treatment phase and usually involves acquiring three-dimensional internal medical images (by CT, MRI) of the subject. During this time, the subject is precisely positioned relative to imaging devices on a movable treatment simulation table. These medical images are used to plan the subsequent extracorporeal radiotherapy treatment. From the images, the radiologist can determine which tissue structures respond to high and low doses. This determines the dose, sensitive structures, and the number of sessions or fractions the patient will receive. The treatment areas described above expose the subject to ionizing radiation.

[0078] The elongated member (210) has a proximal end (40) and a distal end (20). The elongated member (210) may be rigid (non-flexible). The elongated member (210) may also be flexible, which allows the main body to have better resistance to the elongated member (210) and to remain in place within the tube for up to 2-3 months during the course of fractional treatment.

[0079] The elongated member (210) is made to dimensions for insertion into a tube, particularly into the cervix and / or the uterus and / or the recurrent vaginal fornix. The elongated member (210) may have a length of 1 to 10 cm. When the elongated member (210) is configured to be placed in the cervix and / or uterus, its length may be 1 to 8 cm and its maximum outer diameter may be 3 to 8 mm. When the elongated member (210) is configured to be placed in the recurrent vaginal fornix, its length may be 1 to 5 cm and its maximum outer diameter may be 3 to 8 mm. The diameter of the elongated member (210) may be uniform from the proximal end to the distal end, or it may vary. For example, the diameter may be larger towards the proximal end and smaller towards the distal end. 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 results in less trauma during vaginal insertion, while increasing the diameter towards the proximal end improves the rigidity of the slender member (210). Refer to Tables 2 and 2a for recommended dimensions for various medical applications.

[0080] The effector shaft (310) may be configured to cooperate with the elongated member (210) so that the movement of the steering guide is transmitted to the elongated member (210).

[0081] An elongated member (210) may be provided with an elongated member lumen (214). The elongated member lumen (214) is open at its proximal end (40) to allow the effector shaft (310) of the steering guide (300) to be slidably inserted before treatment. The elongated member lumen (214) may be open or closed toward the distal end (20). If it is open, it can provide a drainage channel (270) or an outlet port (272) or a threaded passage (272, -c) for a removable guide strand (218). If the elongated member (210) is permanently attached to the effector shaft (310) of the steering guide (300), the elongated member lumen (214) may be absent or occupied by the effector shaft (310) of the steering guide (300).

[0082] The steering guide (300), attached to the inserter (204) or the elongated member (210), is securely mounted. The rigid mounting minimizes play or backlash between the inserter (204) and the handle portion (316) of the steering guide (300).

[0083] The distal end of the elongated member (210) may be non-traumatic (e.g., having a rounded edge, being dome-shaped, and not requiring an incision). The elongated member (210) may have a circular contour perpendicular to its longitudinal axis. The elongated member (210) may essentially be cylindrical. One or more fins may be provided with the elongated member (210). The fins are projections extending outward from the surface of the elongated member (210). The fins also extend longitudinally. This serves to better secure the elongated member (210) to the inner wall of a tube (e.g., the cervix) and to prevent the elongated member from rotating during operation with the steering guide. Preferably, one or more fins are provided within the proximal (40) half of the elongated member (210), for example, within 2-4 cm of the proximal end (40).

[0084] The elongated member (210) may be a rigid tube. The elongated member (210) may be a flexible tube. The advantage of a flexible tube is that it is more comfortable for the subject while being worn during the treatment period (e.g., several weeks). The walls of the elongated member (210) may be made from any biocompatible material such as polymers. Examples of suitable materials include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, polyurethane, or silicone. Examples of materials used to form a rigid elongated member (210) include polycarbonate, PEEK, carbon fiber, and fiber-reinforced polyacrylamide resin (e.g., Ixef (Solvay)). Examples of materials used to form a flexible elongated member (210) include polyamide, polyimide, polyurethane, or silicone.

[0085] Typically, treatment is first simulated under a CT scan, PET-CT scan, or MRI. Subsequent treatment may include one or more X-ray scans in the treatment room. The elongated member (210) is preferably made from a material suitable for medical imaging such as CT or MRI. The material may or may not be visible on medical images. Examples of materials not visible on CT or CT / PET scans include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, polyurethane, or silicone. A low percentage of barium sulfate may be mixed into the material to improve visibility on CT and PET / CT. Examples of materials visible on MRI scans include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, polyurethane, or silicone. The orientation (position and / or orientation) of the elongated member (210) may be determined directly from medical images of the elongated member (210) under MRI or opaqued with barium sulfate (under CT or PET-CT). Examples of materials that are invisible in CT / PET scans when not mixed with barium sulfate include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, and silicone. If the inserter is invisible or not clearly visible to determine its position and / or orientation, one or more imaging markers may be placed along with the elongated member (210). This is helpful when running images using imaging tools for linear accelerators.

[0086] The inserter (204), particularly the elongated member (210), may be provided with one or more imaging markers (206) that can be identified by medical images. In Figure 1, a pair of imaging markers (206) are fixedly provided on the outer surface of the elongated member (210). The imaging markers (206) can be identified by medical images. The imaging markers (206) may be provided in a fixed relationship with the elongated member (210), for example, on the inner surface, outer surface, or within the body of the elongated member (210). The imaging markers (206) may be protrusions or recesses. They may be made from the same material as the elongated member (210) and may be visible on medical images due to differences in size. The imaging markers (206) may be made from a different material than the elongated member (210), for example, heavy metals such as platinum, platinum-iridium, tantalum, tungsten, or low-density metals such as titanium or coated aluminum.

[0087] The inserter (204), in particular the elongated member (210), may be equipped with one or more (e.g., two, three or more) position-determining radio transponders (260), the positions of which are determined using a spatial transponder detector and may optionally be tracked. The terms position-determining radio transponder and transponder are used interchangeably herein. Transponders are sometimes also known as beacon transponders. In Figure 1, three transponders (260, a, b, c) are fixed to different positions on the outer surface of the elongated member (210).

[0088] A transponder (260) is a device that emits electromagnetic pulses at a specific frequency detectable by a spatial transponder detector, and typically consists of a number of spatially separated receivers (coils). The timing of pulses detected by the device allows for the precise determination of the transponder's position. The transponder (260) can inductively receive power. If multiple transponders are present, each transponder may transmit signals at a different frequency. If at least three separately identifiable transponders (260, a, b, c) are positioned 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. Patents 9,248,003B2 and 9,072,895. The use of transponders reduces the need to align the inserter (204) before radiotherapy using medical imaging, thereby reducing exposure to imaging radiation.

[0089] According to one aspect: - At least a portion of the inserter (204), or one or more imaging markers carried thereon, are visualized by medical imaging, particularly X-ray medical imaging and / or MR medical imaging. and / or - At least a portion of the elongated member (210), or one or more imaging markers supported thereon, are visualized by medical imaging, particularly X-ray medical imaging and / or MR medical imaging. and / or - The inserter (204) and / or the elongated member (210) are each equipped with one or more radio transponders for determining the position and / or orientation of the inserter (204) and / or the elongated member (210) by a spatial transponder detector.

[0090] If the inserter (204) is removable from the steering guide (300), the guide strand (218) may or may not be present. If the guide strand (218) is present, it is at least partially positioned within the elongated member lumen (214) and exits therefrom at its proximal end. The effector shaft (310) of the steering guide (300) may be provided with a guide strand passage (312) for receiving the guide strand (218). The guide strand passage (312) may be a lumen within the effector shaft (310) or a longitudinal groove on the surface of the effector shaft (310). The guide strand (218) is constrained at or toward its distal end (20) to limit or prevent proximal sliding of the guide strand (218) 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) is routed through the proximal end of the guide strand, which continues outside the body, and can be reliably guided into the elongated member lumen (214). The guide strand allows for repeated attachment and removal of the steering guide before and after simulation and / or radiotherapy. Access to the elongated member lumen (214) is possible even when the elongated member lumen (214) is located in its original position, for example, in the cervix.

[0091] The guide strand (218) may be a flexible cord (219) (e.g., composed of another strand) or an expansion tube (236). The outer diameter of the guide strand (218) is smaller than the inner diameter of the effector shaft (310). It is made to dimensions such that it passes through the guide strand passage (312). The guide strand (218) may have a narrow cross-sectional profile of, for example, 0.1 to 2.5 mm (flexible cord) or 1 to 2.5 mm (expansion tube). It may have tensile strength to resist the tension applied thereto while the effector shaft (310) of the steering guide (300) is inserted into the elongated member lumen (214). It may not be expandable in the longitudinal direction. An example of a guide strand (218) that is a flexible cord (219) is shown in Figures 2A, 2C, and 2D. In Figures 2E and 3, this is shown in panels A-F1 and a-f.

[0092] The guide strand (218) may be permanently (e.g., permanently) attached to the inserter (204), or it may be detachably attached to the inserter (204). If the guide strand (218) is detachably attached, it is preferably a flexible cord (219).

[0093] The non-removable attachment to the inserter (204) can be achieved, for example, by knotting it to the support (213) with adhesive during the molding production of the elongated member (210). The distal end of the guide strand (218) is preferably fixedly attached to the elongated member lumen (214), preferably to the most distal end of the elongated member lumen (214). Examples of non-removably attached guide strands (218) are shown in Figures 2A and panels A, B, C, and D of Figure 3.

[0094] By detachably attaching the guide strands (218, 219) to the inserter (204), both operations become possible.

[0095] - If guide strands (218, 219) are present, ensure that the effector shaft (310) is guided into the slender member lumen (214).

[0096] - Insertion of the proximity irradiation applicator into the elongated member lumen (214) when the guide strands (218, 219) are removed.

[0097] There are situations where treatment begins with an extracorporeal radiotherapy program, and subsequently requires close-range radiotherapy. Close-range radiotherapy is well known in the art and is a process of treating a target using an internally ionizing radiation source. The radiation source is located in a sealed capsule at the end of a flexible cable wound around an afterloader storage unit. If necessary, a cable with a certain degree of pushability is sent from the afterloader to a transfer tube connected to a close-range radiotherapy applicator for treatment. The radiation source is held in place by or within the close-range radiotherapy applicator during the treatment period and then retrieved into the afterloader storage unit. The elongated member (210) may be used in-situ as a catheter to enable the introduction of the close-range radiotherapy applicator. If the elongated member (210) is already positioned adjacent to the target, the guide strand (218) is removed and the applicator is introduced into and held within the elongated member lumen (214) in order to irradiate the target.

[0098] If the guide strands (218, 219) are detachably attached to the inserter (204), they are typically flexible cords (219).

[0099] In one example, a removable guide strand (218, 219) is a flexible cord (219) having a fixed end (219, b) with a stop anchor (219, c). The elongated member lumen (214) may have an outlet port (272, -a, -b) at its distal end (20). The guide strand (218, 219) is positioned into the elongated member lumen (214) through a proximal inlet (214, a), distally along the elongated member lumen (214) through the distal outlet port (272, -a, -b), and returns proximal to the proximal end of the inserter (204). The guide strand (218, 219) has a fixed end (219, b) and a free end (219, a). The fixed end (219, b) exits through the outlet port (272, -a, -b). A stop anchor (219, c), such as a ball stop, is provided at the fixed end (219, b). The stop anchor (219, c) is configured to engage with a reciprocating stop section (254) on an inserter (204), such as an elongated member (210) or a stop member (250). The reciprocating stop (254) may be a passage. The reciprocating stop (254) is located at the proximal end of the inserter (204) that is accessible to a specialist when the inserter (204) is in its original position. The free end (219, a) exits the proximal inlet (214, a) into the elongated member lumen (214). The free end (219, a) can pass through the proximal inlet (214, a) into the elongated member lumen (214), the exit port (272, -a, -b), and the reciprocating stop (254) without restriction. The tension on the free end (219, a) of the guide strand (218) engages the stop anchor (219, c) with the reciprocating stop (254), preventing the guide strand (218) from sliding within the elongated member lumen (214). The tension applied to the fixed end (219, b) of the guide strand (218) causes the guide strand (218) to slide within the elongated member lumen (214), while the free end (219, a) passes through the elongated member lumen (214), the exit port (270, -a, -b, -c) and the proximal entrance to the reciprocating stop section (254), ultimately removing the guide strand (218) from the inserter (204). An example of a removable guide strand (218) with a stop anchor (219, c) is shown in Figure 2C and panels E, F, d, e, and f of Figure 3.

[0100] In another example, a removable guide strand (218, 219) is a flexible cord (219) having a threaded distal end (219, d). The distal end (20) of the elongated 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 end (219, d) of the guide strand (218, 219) to engage with the reciprocating threaded passage (272, -c) of the inserter (204), thereby attaching the elongated member (210). Rotation in the other direction releases the flexible cord (219) from the elongated member (210). An example of a guide strand (218) with a removable threaded portion (219, d) is shown in Figures 2D, 2E, and panel O of Figure 3.

[0101] In another example, a removable guide strand (218, 219) is a flexible cord (219) that can be removed by applying a tensile force exceeding a certain threshold. The tensile force may range from 1 kg to 3 kg. In one example, the flexible cord (219) has a breakable portion (219, e) at its distal end, which is attached to an inserter (204), particularly to an elongated member (210). In another example, the flexible cord (219) is attached to the inserter (204) by a coupling that pulls it away from the inserter (204). An example of a guide strand (218) having a breakable portion (219, e) is shown in panel P of Figure 3.

[0102] The guide strand (218), which is a flexible cord (219), can be made from any suitable material, preferably a non-ferromagnetic material such as nylon, or other polymer materials, or a metal such as nitinol. The guide strand (218), which is a relaxation tube, can be made from any suitable material, preferably a non-ferromagnetic material such as a polymer such as polyamide. The guide strand (218), which is an expansion tube, can be made from any suitable material, preferably a polymer such as polyamide, or a non-ferromagnetic material such as a metal such as nitinol. The guide strand (218) may contain an antimicrobial agent or may be coated with an antimicrobial agent. Examples of antimicrobial agents include silver particles, erythromycin, or other antibiotics. Preferably, the guide strand (218) is made from a radiolucent material. Preferably, the guide strand (218) is made from an MRI-compatible and biocompatible material. The distal end of the guide strand is preferably fixedly attached to the most distal end of the elongated member lumen (214).

[0103] The guide strand (218) may also be an expansion tube (236) which is a tube having a lumen that fluidly connects to a distal sliding limiter (220) which is an inflatable balloon assembly (230) (see below). The lumen of the expansion tube (236) is an inflatable balloon assembly The tubular member (210) may be provided with a crimpable or self-expandable cylindrical body (e.g., metal mesh) (240) around the outside of its distal end. This allows the physician to open the metal mesh inside the tube (e.g., inside the uterus (604) by inflating the balloon (balloon-expandable mesh) or by removing a sliding member (self-expanding stent) around the mesh. The inflatable balloon assembly (230) allows the movement of the tubular member inside the uterus to be prevented. The stitches used to attach the inserter to the opening of the cervix may loosen over time as the tumor shrinks. The presence of the distal sliding limiter (220), which is an inflatable balloon assembly (230), prevents the elongated member (210) from sliding downward out of the uterus (604).

[0104] The guide strand (218) may also be a relaxation tube (237), which is a tube having a lumen (238) configured to receive a hardened stylet. The relaxation tube (237) is more flexible in the absence of the hardened stylet, and becomes less flexible (harder and easier to push in) when the hardened stylet is inserted into the lumen (238). Examples of guide strands (218) that are relaxation tubes (237) are shown in panels Q, R, S, T, q, r, t, xxi to xxv of Figure 3. The hardened stylet is more flexible than the relaxation tube (237). The hardened stylet may be a metal or polymer wire. The hardened stylet is not present in the relaxation tube lumen (238) while the inserter (204) is fitted by the subject. The relaxation tube (237) without a hardened stylet has increased flexibility and conforms better to changes in the shape of the subject during insertion, thus enabling a more comfortable insertion of the intubator. Before inserting the steering guide, the hardened stylet is inserted along the lumen (238) of the relaxation tube (237). This increases rigidity and allows the guide strand passage (312) of the effector shaft (310) of the steering guide (300) to be pushed along the hardened relaxation tube (237) with reduced buckling, thus resulting in a faster and less uncomfortable experience for the subject. After simulation of extracorporeal radiotherapy treatment and / or treatment in a specific position of the intubator (204), the steering guide (300) is removed. The hardened stylet may be removed after the steering guide (300) has been inserted or after the steering guide (300) has been removed.

[0105] If the inserter (204) is for the cervix (602), the guide strand (218) is long enough to pass through the vagina (606). The posterior end of the guide strand (218) can be secured with an adhesive pad to the inguinal skin of the subject, for example, between simulation and radiotherapy treatment and / or between radiotherapy treatment segments.

[0106] If the inserter (204) is detachable from the steering guide (300), the inserter may be provided with a guide sleeve (238) having a sleeve lumen (239), the guide sleeve lumen (239) being configured to receive the steering guide effector shaft (310) and guide the steering guide effector shaft (310) into the elongated member lumen (214). The guide sleeve may be attached to the proximal end of the inserter (204) such that the lumen of the elongated member (214) and the lumen of the guide sleeve are continuous. An exemplary guide sleeve is shown in Figure 27.

[0107] The effector shaft (310) of the steering guide (300) can be inserted into the sleeve lumen (239) of the guide sleeve, thereby guiding the effector shaft (310) into the elongated member lumen (214).

[0108] The guide sleeve allows for repeated attachment and removal of the steering guide before and after simulation and / or radiotherapy. Access to the elongated member lumen (214) is possible even when the elongated member lumen (214) is positioned in its original location, for example, in the cervix.

[0109] The guide sleeve (238) may be a thin-walled hollow tube with a flexible wall. The inner diameter of the guide sleeve is larger than the outer diameter of the effector shaft (310). It may have tensile strength to resist the tension applied thereto while the effector shaft (310) of the steering guide (300) is inserted into the guide sleeve. It may not be expandable in the longitudinal direction. When the inserter is used on the cervix, the guide sleeve is long enough to exit through the vagina. The rear end of the guide sleeve may be secured with an adhesive pad to the skin of the target groin, for example, between simulation and radiotherapy treatment and / or between radiotherapy treatment splits.

[0110] The inserter (204) may comprise one or more sliding limiters (220). The elongated member (210) may be provided with one or more sliding limiters (220) configured to reduce or prevent sliding of the elongated member (210) against the pipe, for example as shown in Figures 1, 2A, 2B, 2C, 2D, 3, 5, 5', and 23-25'. The sliding limiters (220) may engage with the wall of the pipe, for example by friction, or abut against the inlet or outlet of the pipe. The sliding limiters (220) may be mounted in a fixed relationship to the elongated member (210). The sliding limiters (220) may be positioned at separate longitudinal locations on the elongated member (210). Examples of sliding limiters include an inflatable balloon assembly (230), an expandable stent (240), and a stopper (250).

[0111] There are two sliding limiters (220), each of which may be positioned at different longitudinal locations on the elongated member (210). One sliding limiter (220) may be positioned at the proximal end (40) of the elongated member (210), and the other at the distal end (20) of the elongated member (210). One sliding limiter (220) may be a stopper (250), and the other sliding limiter may be an inflatable balloon assembly (230) or an expandable stent (240). Such an arrangement allows the two sliding limiters (220) to be positioned on the sides of the tissue located between the inlet and outlet of the tube, effectively clamping the elongated member (210) to it. The two sliding limiters (220) are positioned at both ends of the elongated member (210) in Figure 3 (see combinations in Tables 1a-1e), Figure 24, Figures 24'-26, and Figure 26'. Preferably, one of the two sliding restrictors (220) is a proximal anchor member (250). The arrangement of the two sliding restrictors (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 anchor member (250) is sutured to the cervix. With repeated splitting, the cervical tumor may begin to shrink, the sutures may loosen, and the elongated member may become dislodged. This can be important when the effector shaft (310) is withdrawn after splitting. By inflating a distally positioned balloon assembly (230) or expandable stent (240), the elongated member (210) is fixed within the uterine canal (604) and can withstand the tension applied, for example, during the withdrawal of the effector shaft (310).

[0112] The sliding limiter (220) may also be an inflatable balloon assembly (230). The inflatable balloon assembly (230) may be one or more (e.g., 2, 3, 4) inflatable balloons provided around at least the distal portion (20) of the elongated member (210), as illustrated in Figure 3 (Panels i, ii, iii, vi, vii, viiii, xi, xii, xiii, xvi, xvii, xviii, I, J, K), Figure 21, Figure 22, and Figure 23. It may be equipped with balloons (231, -a to -h). Two inflatable balloons (231, -a, 231, -b) are provided at the distal end of the elongated member (210) and may be optionally arranged diametrically (for example, Figure 3 (Panel i), Figure 24, Figure 24', Figure 22, Figure 25, Figure 22', Figure 25', Figure 26, Figure 26').

[0113] A single inflatable balloon can be provided at the distal end of the elongated member (210) and may optionally have an annular, for example, conical shape (Figure 3, panels ii, vii, xii, xii, xvii, 231, -c; Figure 3, panel M231-g) or barrel shape (Figure 3, panels iii, vii, xiii, xviii, 231, -d; Figure 3, panel N231, -h). The walls of the inflatable balloon (231, -a to -h) may be made from any suitable expandable or non-expandable material. Examples of expandable materials include polyurethane, any elastic polymer, thin-film polymers (such as nylon, compliant polyamides), or other elastomers. The inflatable balloon (231, -a to -h) may have a limited maximum expansion size, thereby resisting expansion beyond the maximum expansion size. The limited maximum expansion size can be achieved by forming the balloon wall from a non-expandable material such as PET, semi-compliant, or non-compliant polyamide.

[0114] The expansion lumen (234) can be fluidly connected to an inflatable balloon (231, -a~-h). The expansion lumen (234) can extend proximal (40) via an expansion tube (236), such as a catheter or a flexible tube. The expansion lumen (234) can be formed within a guide strand (218), as previously described. Thus, the guide strand (218) may be an expansion tube (236), for example, as shown in panels L, M, and N of Figure 3. Alternatively, the expansion tube (236) may be located outside the elongated member (210), for example, as shown in panels i, ii, iii, vi, vii, viiii, xi, xii, xiii, xvi, xvii, xviii, Figure 24', Figure 25', and Figure 26'. The expansion tube (236) can extend proximal outside the elongated member (210).

[0115] The expansion lumen (234) allows for the inflation of an inflatable balloon lumen (232) from the outside of the uterine duct after the elongated member (210) has been positioned. The inflatable balloons (231, -a to -h) can be deflated after treatment by releasing an inflation fluid (e.g., saline or sterile water) from the balloon lumen (232) through the expansion lumen (234). The inflation fluid may contain a contrast agent. Figures 24 to 26 and 24' to 26' illustrate a positioning tool (200) with an inflatable balloon assembly (230), in which the inflatable balloons (231-e, 231-f, 231-h) are positioned within the uterine duct (604) and inflated to prevent or reduce the sliding movement of the elongated member (210). An expansion tube (236) for controllable inflation and deflation of the balloons (231-e, 231-f, 231-h) is also shown. As mentioned above, the expansion tube (236) is a guide strand (218).

[0116] An inflatable balloon (231, -a to -h) may be used to prevent the elongated member from being pushed out of the uterine canal during effector shaft retrieval and to improve uterine positioning. In this case, the balloon (231-a to 231-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 improved accuracy of uterine positioning by reducing the degrees of freedom of the elongated member (210) within the uterine canal (604). Furthermore, as the cervical tumor begins to shrink, the sutures securing the elongated member (210) to the cervix may loosen, potentially causing the elongated member to detach. By inflating the balloon, the elongated member is automatically secured within the uterine canal. The balloon (231-a to 231-h) can be used throughout the treatment period (e.g., 1 to 8 weeks), even between divisions. Even if there is a gap, it can be permanently expanded to prevent the elongated member (210) from detaching from the uterine canal (604).

[0117] The sliding limiter (220) may be an expandable stent (240). The expandable stent (240) may be provided around at least the distal portion of the elongated member (210), as illustrated in panels v, x, xv, and xx of Figure 3. It may be made from any suitable expandable material such as biodegradable metals such as CoCr alloy, Finox, Nitinol, magnesium alloy, and zinc alloy, iron, or biodegradable polymers. The expandable stent may be self-expanding or balloon-expanding. The stent may shrink after treatment by covering it with a sliding sheath that limits its shape. Expandable stents are well known in the art and typically have a tubular shape, with walls that are cut from a tube or made from braided wire and have a radially expanding mesh structure.

[0118] The stopper member (250) may be provided at the proximal end of the elongated member (210), as illustrated in panels a, b, d, e, g, h, k, l, n, and o of Figure 3. The stopper member functions as a distance limiter, preventing the elongated member (210) from sliding further into the pipe when it abuts against the pipe inlet. The stopper member is positioned at the proximal end of the elongated member (210). The stopper member protrudes from the outer surface of the elongated member (210). The stopper member (250) is provided in a fixed (immovable) relationship with the elongated member (210). The stopper member (250) may be rigid. The stopper member may include an annular structure, which may be formed from the same material as member (210) or from a different material. The stopper member (250) may be provided with one or more suture channels (252). The suture channel allows the stopper to be sutured to the entrance of the tube, for example, to the ridge of the cervix. Figures 5, 5' and 23-25, 23'-25' illustrate an inserter (204) with a stopper (250) at the proximal end of an elongated member (210). The placement tool (200) is positioned within the cervix (602), or within the cervix (602) and uterine canal (604), and the sliding movement of the elongated member (210) is prevented or reduced by the stopper contacting the ridge of the cervix (602).

[0119] The sliding limiter (220) may be a region of the distal portion of the elongated member (210) including one or more distal projections. The distal projection may be a lateral projection (245), as illustrated in panels iv, ix, xiv, and xix of Figure 3. The distal projection may be an annular ring or a segment. The distal projection (245) functions as a limiter that prevents or reduces the further sliding of the elongated member (210) into the pipe when the elongated member (210) contacts the pipe wall. The distal projection (245) is located at the distal end of the elongated member (210). The distal projection (245) protrudes from the outer surface of the elongated member (210). The distal projection (245) is provided in a fixed (immovable) relationship with respect to the elongated member (210). The distal projection (245) may be rigid. The distal projection (245) may include an annular structure. This may be formed from the same material as the member (210) or from a different material.

[0120] The elongated member (210) may be provided with one or more drainage channels (270, -a, -b, -c) at its distal end (20), for example, as shown in panels B, C, D, H, J, K of Figure 3. The drainage channels fluidly connect the elongated member lumen (214) to the outer surface of the elongated member (210). The drainage channels (270, -a, -b) may be provided toward the distal end of the elongated member (210). The distal end of the elongated member (210) is open to the elongated member lumen (214), thereby forming a drainage channel (270, -b) (e.g., panels C, G of Figure 3). If a guide strand (218) is present, it can be attached to a support (213) attached to the elongated member lumen (214) that does not obstruct the fluid passage (e.g., panel C of Figure 3). The discharge channel (270, -c) is an elongated member lumen (21 4) may be provided on the side wall. The drainage channel (270) allows for the safe removal of any fluid that may accumulate in the uterine duct. The fluid exits from the proximal end of the elongated member lumen (214) before and after simulation and / or radiotherapy treatment, if the effector shaft is not inside the elongated member, and enters, for example, the vaginal passage (606). The drainage channel allows for the drainage of fluid from the tube, thereby significantly reducing the risk of infection. The drainage channel may also function as an exit port for the guide strand (218) and vice versa. The drainage channel may also function as a threaded passage (272, -c) for a removable guide strand (218) and vice versa.

[0121] The inserter may be provided with any one of a number of different arrangements of a discharge channel (270), an outlet port (272), a threaded passage (272, -c), a lateral restrictor (220), and a guide strand (218). For example, a distal sliding restrictor, a proximal sliding restrictor, and one or more drainage channels may be provided or not. If both drainage channels and distal sliding restrictors (Figure 3, i-xv) are present, the drainage channels may be adjacent to one of the ends of the distal sliding restrictor.

[0122] In Figure 3, any one of the elongated members (A, B, C, D) may be combined with a proximal sliding limiter (a, b), or it may not be combined with a proximal sliding limiter (c). The elongated members (A, B, C, D) may or may not include a distal sliding limiter (i, ii, iii, iv, v).

[0123] Furthermore, in Figure 3, one of the elongated members (E, F) may be combined with the proximal sliding limiter (d, e), or it may not be combined with the proximal sliding limiter (f). The elongated members (E, F) may or may not include the distal sliding limiters (vi, vii, viiii, ix, x). The guide strand is removable.

[0124] Furthermore, in Figure 3, any one of the elongated members (G, H, J, K) may or may not be combined with the proximal sliding limiter (g, h). The elongated members (G, H, J, K) may or may not include the distal sliding limiters (xi, xii, xiii, ix, x). There is no guide strand.

[0125] Furthermore, in Figure 3, one of the elongated members (L, M, N) having distal sliding limiters may be combined with a proximal sliding limiter (k, l), or it may not be combined with a proximal sliding limiter (m). The guide strand is an expansion tube.

[0126] Furthermore, in Figure 3, either one of the elongated members (O, P) may be combined with the proximal sliding limiter (n, o), or it may not be combined with the proximal sliding limiter (p). The elongated members (O, P) may or may not include the distal sliding limiters (xvi, xvii, xviii, xix, xx). The guide strand is removable.

[0127] Furthermore, in Figure 3, any one of the elongated members (Q, R, S, T) may be combined with the proximal sliding limiter (q, r), or it may not be combined with the proximal sliding limiter (s). The elongated members (M, N, O, P) may or may not include the distal sliding limiter (xxi, xxii, xxiii, xxiv, xxv). The guide strand is a relaxed tube.

[0128] When both distal sliding limiters (i-xxv) and drainage channels or outlet ports are present, the distal sliding limiters (i-xxv) may be positioned within a region (e.g., 211) of an elongated member (210) that does not obstruct the drainage channel. Examples of various combinations are shown in Tables 1a-1f below. Exemplary elements referenced in Tables 1a-1f are shown in Figure 3.

[0129] [Table 1a]

[0130] Table 1a shows the characteristics of the inserter (204) when the guide strand (218) is a flexible cord (219). This is an example combination. Key: A - Elongated member, no drainage channel, B - Elongated member at the distal end Drainage channel, C - elongated member with an open distal end, D - drainage channel of the elongated member at the distal end of the side wall. a - proximal stop member (sliding restrictor) with suture channel, b - proximal stop member (sliding restrictor) without suture channel, c - no proximal stop member (sliding restrictor). i - pair of distal balloons (sliding restrictor), ii - distal cone balloon (sliding restrictor), iii - distal barrel balloon (sliding restrictor), iv - distal projection (sliding restrictor), v - expandable stent (sliding restrictor), GS guide strand. Figure 3 shows exemplary implementations of each feature (A, B, C, D, a, b, c, i, ii, iii, iv, v).

[0131] [Table 1b]

[0132] Table 1b shows exemplary combinations of inserter features when the guide strand is removable. Key: E - Elongated member with an exit port as a passage, F - Exit port open at the distal end Elongated member equipped with: d-proximal stop member (sliding restrictor) with suture channel and reciprocating stop section, e-proximal stop member (sliding restrictor) without suture channel and equipped with reciprocating stop section, f-elongated member without proximal stop member (sliding restrictor) and equipped with reciprocating stop section. vi-pair of distal balloons (sliding restrictor), vii-distal conical balloon (sliding restrictor), viii-distal barrel balloon (sliding restrictor), ix-distal Positional projection (sliding limiter), x-expandable stent (sliding limiter), GS guide strand. Figure 3 This shows exemplary implementations of each feature (E, F, d, e, f, vi, vii, viii, viii, ix, x).

[0133] [Table 1c]

[0134] Table 1c shows exemplary combinations of inserter features when guide strands are absent. Key: G - Elongated member, no drainage channel, H - Drainage channel of elongated member at distal end, J - Distal end An open elongated member, a drainage channel for the elongated member at the distal end of the side wall K, a proximal stop member (sliding limiter) with a suture channel g, a proximal stop member (sliding limiter) without a suture channel h (G) - No proximal stopping member (sliding restrictor), xi - Pair of distal balloons (sliding restrictor), xii - Distal conical balloon (sliding restrictor), xiii - Distal barrel balloon (sliding restrictor), xiv - Distal projection (sliding restrictor), xv - Expandable stent (sliding restrictor), GS guide strand. Figure 3 shows the features of each (G Examples of implementations of H, J, K, g, h, j, xi, xii, xiii, xiv, xv) are shown.

[0135] [Table 1d]

[0136] Table 1d shows the characteristics of the inserter (204) when the guide strand (218) is an expansion tube (236). This is an example combination. Key: L - Elongated member with a pair of distal balloons (sliding limiter), M - distal N-Elongated member with a conical balloon (sliding limiter), N-Elongated member with a distal barrel balloon (sliding limiter). k-Proximal stopper (sliding limiter) with suture channel, l-Proximal stopper (sliding limiter) without suture channel, m-No proximal stopper (sliding limiter), GS guide strand. Figure 3 shows exemplary implementations of each feature (L, M, N, k, l, m).

[0137] [Table 1e]

[0138] Table 1e shows exemplary combinations of inserter features when the guide strand is removable. Key: O - Elongated member with threaded passage (272,-c), P - Elongated member with breakable connection Guide strand attached to the proximal stop member (sliding stop) with n-suture channel. (Limiter), o-Proximal stop member without suture channel (sliding limiter), p-No proximal stop member (sliding limiter). xvi-Pair of distal balloons (sliding limiter), xvii-Distal conical balloon (sliding limiter), xviii-Distal barrel balloon (sliding limiter), xix-Distal projection (sliding limiter), xx-Expandable stem Thread (sliding limiter), GS guide strand. Figure 3 shows exemplary implementations of each feature (O, P, n, o, p, xvi, xvii, xviii, xix, xx).

[0139] [Table 1f]

[0140] Table 1f shows the characteristics of the inserter (204) when the guide strand (218) is a relaxation tube (237). This is an example combination. Key: Q - Elongated member, no drainage channel, R - Elongated member at the distal end Drainage channel, S - elongated member with an open distal end, T - drainage channel of the elongated member at the distal end of the side wall. q - proximal stop member (sliding restrictor) with suture channel, r - proximal stop member (sliding restrictor) without suture channel, s - no proximal stop member (sliding restrictor). xxi - pair of distal balloons (sliding restrictor), xxii - distal cone balloon (sliding restrictor), xxiii - distal barrel balloon (sliding restrictor), xxiv - distal projection (sliding restrictor), xxv - expandable stent (sliding restrictor). Figure 3 This shows exemplary implementations of each feature (Q, R, S, T, q, r, s, xxi, xxii, xxiii, xxiv, xxv).

[0141] The placement tool (200) may further include a steering guide (300) for controlling the position and / or direction of, for example, an inserter (204), as shown in Figures 5 to 10, 15 to 21, and 26, 26', and 32A. The steering guide (300) has a proximal end (40) and a distal end (20). The steering guide (300) can be detachably attached to the inserter (204) or an elongated member (210). The steering guide (300) may or may not have a guide strand passage (312) for sliding along a guide strand (218). If a guide strand passage (312) is present, it may be provided at least partially along the length of the steering guide (300), for example, along an effector shaft (310) and / or transmission (314), as will be described later.

[0142] The effector shaft (310), positioned at the distal end (20) of the steering guide, is attached to or can be attached to the inserter (204) or the elongated member (210). The effector shaft (310) may be removably attached to the inserter (204) or the elongated member (210). The effector shaft (310) may be permanently attached to the inserter (204) or the elongated member (310). The effector shaft (310) may be configured for (repeated) sliding and removable insertion into the elongated member lumen (214). The effector shaft (310) may be configured to slide and remove into the elongated member lumen (214) along the guide strand (218) present in the inserter (204). The effector shaft (310) may have a circular cross-sectional shape perpendicular to its longitudinal axis. The shape may have the same size in the axial direction. The outer shape may taper in the axial direction. A small contour may be present at the distal end.

[0143] If the steering guide (300) does not have a guide strand passage (312), the effector shaft (310) can be introduced into the elongated member lumen (214) of the original inserter (204) using a microscope, providing the physician with a line of sight to the elongated member lumen (214). Examples of steering guides (300) without guide strand passages (312) are shown, for example, in Figures 5', 6', 8', 9', 15', 17', 26', and 32A. An image acquisition system (360) illustrated in Figure 32 shows the distal tip (361) of the effector shaft (310) with an image inlet port (364) for receiving object light and multiple light outlet ports (362) for illuminating the object from a light source. Real-time images captured by the image acquisition system (360) help the physician guide the effector shaft (310) into the elongated member lumen (214).

[0144] The effector shaft (310) may be positioned with one or more recesses on a surface that cooperates with complementary projections on the inner surface of the elongated member lumen (214). This arrangement allows the effector shaft (310) to latch into the elongated member lumen (214). The effector shaft (310) can then click into place in the inserter (204). The effector shaft (310) is removed by pulling it over the latching force.

[0145] The effector shaft (310) is preferably rigid. Preferably, it is non-flexible. It may be formed from a substantially rigid rod. It may have a straight shape for use, for example, in the cervix and / or uterus. It may have a curved shape.

[0146] The effector shaft (310) may be provided with guide strand passages (312) for sliding along guide strands (218). The guide strand passages (312) may be tubular in the effector shaft (310) (e.g., Figures 6, 7, 8, 9, 15, 17, 18) or longitudinal grooves on the surface of the effector shaft (310) (e.g., Figure 10, and detail figure 10A). The guide strand passages (312) may be provided at least partially along the longitudinal length of the effector shaft (310). An inlet (312, -a) to the guide strand passage is located at the distal end of the effector shaft (310), preferably at the distal tip. An outlet (312, -b1 to -b5) from the guide strand passage is located proximal (i.e., proximal side) to the inlet (312, -a). Figure 6 shows various possible locations for 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) may be located at the distal end of the effector shaft (310). The outlet (312, -b2) to the guide strand passage (312) may be located at the proximal end of the effector shaft (310). The outlet (312, -b3) to the guide strand passage (312) may be located at the distal end of the transmission (314). The outlet (312, -b4) to the guide strand passage (312) may be located in the middle portion of the transmission (314). The outlet (312, -b5) to the guide strand passage (312) may be located at the proximal end of the transmission (314).

[0147] In Figure 7, the inlet (312, -a) of the guide strand passage (312) is located at the distal end 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) connects with the distal end of the handle portion (316). In Figure 9, the inlet (312, -a) of the guide strand passage (312) is located at the distal end of the effector shaft (310), and the outlet (312, -b2) is located toward the proximal end of the effector shaft (310). The longer the distance from the inlet (a) to the outlet (b), the longer the guide strand (218). In Figures 15, 17, and 18, the entrance (312, -a) of the guide strand passage (312) is located at the distal end of the effector shaft (310), and the exit (312, -b4) is located toward the middle section of the transmission (314).

[0148] The effector shaft (310) 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 polyallylamide resin (e.g., Ixef (Solvay)), or coated aluminum.

[0149] Typically, the treatment is first simulated under a CT scan, PET-CT scan, or MRI. Subsequent treatment may include one or more X-ray scans in the treatment room. The effector shaft (310) is preferably made from a material suitable for medical imaging such as CT, MRI, or X-ray. The material may or may not be visible on the medical images.

[0150] If the effector shaft (310) is visible in the medical image, its 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 manufactured from low-density materials such as PEEK, polycarbonate, fiber-reinforced polyallylamide resin (e.g., Ixef (Solvay)), or from MR-compatible (non-magnetic) materials such as aluminum coated with a layer of biocompatible metal (titanium) or titanium. In CT scan simulations, coated aluminum or titanium, PE EK, polycarbonate, or fiber-reinforced polyallylamide resin (e.g., Ixef(Solvay)) (mixed with barium sulfate) also have advantages because they can reduce artifacts compared to using high-density metals such as stainless steel. One embodiment uses a coated aluminum, PEEK, polycarbonate, or fiber-reinforced polyallylamide resin (e.g., Ixef(Solvay)) steering guide (300) (mixed with barium sulfate) for simulation and stainless steel for processing. Another embodiment uses an aluminum steering guide (300) or PEEK, polycarbonate, or fiber-reinforced polyallylamide resin (e.g., Ixef(Solvay)) (mixed or unmixed with barium sulfate) for simulation and processing. Most modern imaging devices combined with radiotherapy treatment devices allow for good visualization of metallic structures or radiation-visible polymers, such as effector shafts (310). In this case, the effector shaft may be visible on its own, and the presence of imaging markers visible by the imaging device may not be necessary.

[0151] If the effector shaft (310) is not visible or not visible enough to determine the position and / or orientation of the inserter, one or more imaging markers may be placed on the effector shaft (310). This is useful when performing imaging using imaging tools for a linear accelerator. 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, for example, on the inner surface, outer surface, or within the body of the effector shaft (310) in a fixed relationship with the effector shaft (310). The imaging markers may be made from a different material from the effector shaft (310), such as heavy metals such as platinum, platinum-iridium, tantalum, or tungsten.

[0152] The effector shaft (310) may have a length (E) of 1 to 10 cm, preferably 4 to 10 cm, when inserted into the cervix / uterus. The maximum outer diameter may be 0.3 to 0.7 cm. The outer diameter of the effector shaft (310) may be uniform from the proximal end to the distal end, or it may vary. For example, the diameter may increase towards the proximal portion and decrease towards the distal portion. The change in diameter may be gradual. The change in diameter may change gradually over the length of the effector shaft (310). The effector shaft may employ an angle alpha with respect to the transmission (e.g., Figure 6, Figure 6'). The angle alpha is measured in the plane formed between the transmission and the effector. When the handle and effector shaft are on the same side (sis) of the transmission, the angle alpha is less than 180 degrees. When the handle and effector shaft are on opposite sides of the transmission (trans), the angle alpha is greater than 180 degrees. When the handle and effector shaft are coaxial or linear, angle alpha is 180 degrees. Refer to Tables 2 and 2a for dimensions and angles suitable for various medical applications.

[0153] The handle portion (316), positioned at the proximal end (40) of the steering guide (300), is provided in a fixed relationship (position and direction) with respect to the effector shaft (310). Therefore, directional and / or positional movement of the handle portion (316) causes a corresponding directional and / or positional movement of the effector shaft (310). The handle portion (316) is preferably rigid; preferably non-flexible. It may be formed from a substantially rigid rod.

[0154] The handle portion (316) may have a length (H) of 2 to 50 cm, preferably 15 to 25 cm, when applied to the cervix / uterus. In very obese subjects, the length of the handle portion (316) can be up to 40 cm or 50 cm. The diameter may be 0.3 to 3 cm, preferably 0.5 to 2 cm.

[0155] The handle portion can employ an angle beta relative to the transmission (e.g., Figures 6 and 6'). The angle beta is measured within the plane formed between the transmission and the handle portion. When the handle and effector shaft are on the same side (sis) of the transmission, the angle beta is less than 180 degrees. When the handle and effector shaft are on opposite sides of the transmission, the angle beta is greater than 180 degrees. Refer to Tables 2 and 2a for dimensions and angles suitable for various medical applications.

[0156] 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 polyallylamide resin (e.g., Ixef (Solvay)), polyphenylsulfone (PPSU), aluminum (coated), bioceramics such as aluminosilicate, styrene acrylonitrile, or bioceramic polymer materials. The handle portion (316) may be made from the same material as the transmission (314). The handle portion (316) may have the same diameter as the proximal end (40) of the transmission (314).

[0157] The handle portion (316) may be formed from an imaging-permeable material such as a polymer rod or tube. To facilitate manufacturing, the transmission (314) may be formed from the same material. This can reduce imaging artifacts caused by the transmission (314) in the vaginal region (606). This will be explained in more detail below. An example of a suitable polymer is polycarbonate. Other materials that can be used for the handle portion include glass fiber, carbon fiber, fiber-reinforced polyallylamide resin (e.g., Ixef(Solvay)), polyphenylsulfone (PPSU), bioceramics such as aluminosilicates, styrene acrylonitrile, and bioceramic polymer materials. Figures 7, 8, 8', and 15–17' show examples of steering guides (300) formed from a polymer handle portion (316) and a transmission (314), both having a larger diameter (e.g., 0.8–2.5 cm) compared to the effector shaft (310), which can be formed from hard metals such as titanium or hard polymers (polycarbonate, PEEK, fiber-reinforced polyallylamide resin (e.g., Ixef (Solvay))).

[0158] The steering guide (300), particularly the handle portion (316) and / or 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 also include an RFID tag reading unit, which includes an RFID tag reader and a processor or interface to a processor configured to prevent the robotic arm from operating if the RFID tag does not match an expected RFID tag stored in the system. Since the radiology oncology department may have multiple steering guides of different sizes for use with different subjects (see, for example, Table 1 of this specification), the provision of RFID tags prevents the provision of the wrong steering guide (300) to a subject. The RFID tags may be located within the body of the steering guide (300). In particular, they may be located in slots provided in the reinforcing struts (317) (see, for example, Figures 15, 16, 17, 19-21). For example, it may be placed in a slot provided on the side of the handle (316). The RFID tag may be rewritable or non-rewritable. A non-rewritable RFID chip allows the steering guide to be associated with only one patient, reducing workflow errors. The system cannot rewrite the steering guide RFID chip for use on another patient.

[0159] The handle portion (316) may be configured to be attached to the placement device. The attachment is preferably 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, chucks, and grippers) for removable attachment to the handle portion. This has a base fixed to the floor, ceiling, or a simulation table or treatment table, etc. Preferably, the base of the placement device is fixed to or can be fixed to the simulation table or treatment table between the legs of the subject. The end effector has multiple degrees of freedom of movement (e.g., 3, 4, 5, 6, 7, 8) and the position and / or orientation of the end effector. The placement device may have multiple links connected in a kinetic chain by rotary joints, also known as axes. Having many axes (3, 4, 5, 6, 7, 8, etc.) allows the end effector to adopt a variety of controllable positions and orientations.

[0160] The joints of the placement device may be passive (non-motorized). In a passive system, the joints may be manually adjustable, releaseable, and lockable. When the orientation (position and / or direction) of the end effector is manually set, the joints are locked and the orientation of the end effector is fixed. The joints of the placement device may be motorized. The placement device may be a robotic arm (RA). In a robotic arm, the position of the joints, and therefore the orientation (position and / or direction) of the end effector mount (RA mount), can be controlled by electronic signals.

[0161] RA(400) comprises a base end (422), an effector end (424), and a plurality of intervening linkages (428-1 to -6 or -7) connected by joints (426-1 to -6 or -7). Here, the arrangement of linkages and joints provides the effector end with at least 3, 4, 5, or 6 degrees of freedom (DOF), preferably 6DOF of motion. An exemplary arrangement of joints and linkages is shown in Figure 33, where each joint (426-1 to -6 or -7) is a rotational joint. The joints are typically actuated by a motor, hydraulics, or pneumatics, and the position and orientation of the effector end can be controlled by electronic signals. Each joint, also called a kinematic pair, may provide 1 or 2 degrees of freedom (DOF), preferably 1DOF of motion. The joints may be rotational or linear joints. A rotational joint has one degree of freedom of motion of rotation. A linear joint has one degree of freedom of motion of linear displacement, i.e., sliding. Typically, a robotic arm consists of six joints, each with 1 DOF, generating 6 DOF of motion to the effector end. If the robotic arm includes more than six joints, the effector's position and orientation can be obtained using multiple different combinations of joint positions, providing redundancy useful, for example, when the robotic arm's path is restricted. Joints include those integrated into the RA (Robot Arm) and those added via adapters attached to the effector end of the robotic arm.

[0162] Force sensors can be provided in one or more, preferably all, joints of the RA to detect the application of external forces to the joints. If the joints are rotational joints, joint torque sensors may be embedded in each joint to measure joint torque. External forces may be applied to the links or effector ends. Force detection can detect collisions of the links with other objects such as adjacent instruments or linear accelerator heads, or collisions of the links with objects or medical professionals. By detecting external forces, the forces acting on steerable tools can be detected. Joint torque sensors are already incorporated in some commercially available robot arms, such as those manufactured by Kuka (KukaLBRMed, Germany).

[0163] The robotic arm may be commercially available, for example, manufactured by Kuka, or it may be a commercially available robotic arm adapted to an existing robotic arm. Adaptations include, for example, replacing one or more joints or linkages, or adding one or more controllable degrees of freedom using adapters attached to the end of the effector, thereby creating a new effector end by adding force sensors or grippers to the effector end.

[0164] The RA(400) can be custom-made to comply with size requirements imposed by simulation tables, radiotherapy treatment tables, ionizing radiation therapy heads, medical imaging devices, etc. The operating height of the RA(400), measured from the top surface of the radiotherapy treatment table (512) and simulation table (522) to the maximum operating height of its linkage, may be less than 50-55 cm. Typically, the distance between the simulation table (522) and the top of the CT scanner bore ceiling is 50-55 cm or less. Typically, the distance between the treatment table (512) and the outer surface of the linear accelerator collimator is a maximum of 50 cm. The RA(400) may be compatible with medical imaging (e.g., CT, MRI, or X-ray). The RA(400) may be compatible with ionizing radiation beams emitted by ionizing radiation therapy heads. The RA(400) may be compatible with linear accelerators.

[0165] The operating height of the RA(400), measured from the top surface of the radiotherapy treatment table (512) or simulation table (522) to the maximum operating height of its linkage, may be less than 50-55 cm.

[0166] The processing unit may be configured to limit the operating height of the RA(400), measured from the top surface of the radiotherapy treatment table (512) or simulation table (522) to the maximum operating height of its linkage, to less than 50-55 cm.

[0167] The radiotherapy apparatus (RA) may be controlled by a processing unit (440) comprising a processor and memory. The processing unit may be implemented as a collection of connected computing devices or as a collection of computing devices within a computing device such as a desktop PC, laptop, or dedicated programmable controller. The processing unit may be provided in part or in whole by a processor and memory located within the RA or the radiotherapy device (510) or the medical imaging device (520). The processing unit may be configured to perform one or more of the methods or parts thereof described herein. The processing unit (440) may be configured to control the movement of the RA (400). The processing unit (440) may be configured to control the movement of the placement tool (200), for example, to perform docking of the robotic arm to the handle portion (316).

[0168] The RA may have a switchable zero-gravity mode. In zero-gravity on (zero-gravity) mode, the joints of the robotic arm may or may not be supported (e.g., by servos) to prevent the arm from collapsing. The posture of the RA attachment may be manually guided, for example, by medical staff. This facilitates the connection between the placement tool (200) and the RA attachment when the placement tool (200) has already been inserted into the target. The posture of the steering guide (300) can also be manually fine-tuned for simulation and treatment. Once the 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 in this specification. Since the RA operating in zero-gravity on mode can continue to record the posture of the RA attachment, when the zero-gravity mode is deactivated (zero-gravity off mode), the RA can continue to be controlled to a treatment or simulation posture by the controller processing unit (440) and the steering guide (300) without any intervention calibration operations. Therefore, when entering zero-gravity off mode, the orientation of the RA attachment is initially determined from the last registered orientation of the RA attachment when exiting zero-gravity on mode.

[0169] The positioning device (e.g., a robotic arm) is typically arranged such that the end effector is positioned between the patient's legs. Robotic arms are known in the art and are manufactured, for example, by Universal Robots (Denmark) or Kuka (Germany). The positioning device may be manually adjustable. The positioning device (e.g., a robotic arm) is typically arranged such that the end effector is positioned between the patient's legs.

[0170] To facilitate attachment to the positioning device, the handle portion (316) may be provided with a grip locator (300) configured to cooperate with an end effector fixture (430), and the end effector fixture includes a gripper (432), for example, a set of jaws. The gripper (432) is preferably the end effector fixture (430) of the robotic arm (400).

[0171] The gripper (432) typically includes a pair of arms (jaws). The gripper (432) may be configured such that one or both arms move towards each other (for gripping) or away from each other (for releasing or docking). The gripper (432) usually has an open state (arms further apart) and a closed state (arms further connected). The open gripper (432) is configured such that the arms are positioned on the sides of the grip locator (300). By moving to the closed state, the grip locator (300) will be fixed within the gripper (432).

[0172] The closed gripper (432) may be configured to repeatedly position the grip locator (300). The positioning feature facilitates repeatable positioning such that the gripper (432) and the grip locator (300) cooperate in the same position and / or orientation each time.

[0173] The closed gripper (432) may be configured as a movement (displacement and / or rotation) limiter to limit (prevent or limit) the rotation and / or displacement of the grip locator (300) fixed within the gripper (432) relative to the gripper (432). The grip locator (300) may comprise one or more movement limiters configured to cooperate with one or more complementary movement limiter members of the closed gripper (432). This limits (prevents or limits) the movement of the grip locator (300) fixed to the gripper (432). The cooperating movement limiters also facilitate position-repeatable mounting so that the gripper (432) and grip locator (300) cooperate in the same position and / or direction each time. By avoiding friction, the gripper (432) and associated actuators can be made lighter because they do not need to exert frictional forces.

[0174] A motion limiter restricts (prevents or limits) movement by using a stopping member that restricts rotation and / or displacement (usually without friction). The stopping member engages when the gripper (432) and grip locator (300) cooperate. The cooperating stopping member also facilitates position-repeatable mounting so that the gripper (432) and grip locator (300) cooperate in the same position and / or direction each time. By avoiding friction, the gripper (432) and associated actuator can be made lighter because they no longer need to exert frictional forces.

[0175] By using the gripper (432) (set of arms), the gripper has an open position, meaning that the grip locator (300) can fit into the open jaws, thus allowing for non-contact alignment with the grip locator (300). By closing the gripper (432), the attachment is secured with minimal disruption to the posture of the placement tool (200) inserted into the body, compared to a screw connection which can cause twisting of the placement tool (200).

[0176] The grip locator (300) comprises a longitudinally rigid bar that is part of the handle portion. The grip locator (300) is configured to be inserted into the opening of the gripper (432). In particular, the grip locator (300) is configured to be inserted into the opening of the gripper (432) by a non-axial approach (e.g., radial). As described above, the grip locator (300) may comprise one or more stop members configured to cooperate with one or more complementary stop members of the closed gripper. The stop members of the grip locator (300) may take the form of projections, recesses, notches or corners or similar structures, and the complementary stop members may take the form of complementary structures that tightly engage with the stop members of the grip locator (300). The engagement of the stop members of the grip locator (300) and the (complementary) stop members of the gripper (432) restricts (prevents or limits) rotation and / or displacement. This engagement also facilitates position-reproducible coupling.

[0177] The grip locator (300) may comprise one or more notches (334) and / or one or more protrusions and / or one or more corners (332) that cooperate with the end effector mounting fixture. The configured one or more notches (334) and / or one or more protrusions and / or one or more corners (332) may be configured to cooperate with one or more complementary structures of the closed gripper.

[0178] The grip locator (300) is securely fixed within the closed gripper, restricting and preventing rotation and / or movement between the gripper and the handle portion (316). Exemplary grip locators are shown in Figures 11–16, 19–21, and 32A. The grip locator (300) may be positioned at the proximal end of the handle portion (316). The base of the notch (334) may be pointed, flat, or linear (e.g., a long apex). The notch (334) may have straight (e.g., radial) or chamfered sides. The grip locator (330) enables highly accurate and repeatable detachable mounting of the end effector fixture to the handle portion (316). The grip locator enables high positional repeatability of the grip by the handle portion (316) and reduces play and backlash. The end effector mounting fixture connected to the grip position (300) securely attaches the positioned end effector mounting fixture to the grip position (300) in a fixed relationship.

[0179] The jaws or arms of the gripper (432) may include one or more complementary structures that engage with grip locators on the handle portion (316) when the gripper is closed. The jaws or arms of the gripper (432) may be provided with one or more projections that engage with grip locators (e.g., one or more notches) on the handle portion (316) when the gripper is closed. If the sides of the notches are chamfered, the chamfered projections on the gripper align the steering guide (300) when closed.

[0180] Examples of notches (334) of the grip locator (330) are shown in Figures 11-13, 15A-15C, and 16. In Figure 11, linear side notches (334), each having a flat base, are separated in the longitudinal direction and provided at different radial positions. In Figure 12, a proximal set of linear side notches, each having a flat base, are provided so that their longitudinal positions are the same but their radial positions are different, and a distal set of notches is provided so that their longitudinal positions are different from the proximal set but they are at the same radial position. In Figure 13, the notches are similar to those in Figure 12. They are arranged, but they have chamfered sides (V-shaped) and straight bottoms. In Figures 15B, 15C, and 16, chamfered side (V-shaped) notches (334) with a straight base are provided.

[0181] 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 corner (332) may be square. There may be only one corner. The grip locator (330), which is a combination of a notch (334) and a corner (332), enables a stable grip by the end effector mount when the end effector mount is a gripper having a pair of jaws. At least one notch and corner may have different relative directions, preferably perpendicular. At least one notch may be provided within the longitudinal range 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 fully repeatable fixation of the steering guide to the end effector mount and eliminates further uncertainty in the position of the steering guide relative to the base end of the mounting device.

[0182] In Figures 15B, 15C, and 16, a grip locator (330) is positioned at the proximal end of the handle portion (316), and a chamfered side (V-shaped) notch (334) with a straight base is provided within the longitudinal range of the corner. Figure 15A shows an end view of the handle portion (316) showing the corner (332).

[0183] The gripper jaws (432) can close to form a contour similar to the cross-section of the grip locator (330). In particular, the contour can complement the corners (332) of the grip locator (330). When the jaws are closed, the corners (332) that fit within the contour of the jaws ensure that the steering guide (300) is accurately and stably aligned with the placement device.

[0184] The handle portion (316) may be provided with a docking beacon (340) configured to provide information regarding the position and optional direction of the steering guide (300) relative to the end effector mounting fixture. The docking beacon (340) enables manual, semi-automatic, or automatic guidance of the handle portion (316), particularly to the grip locator (330), of the end effector mounting fixture equipped with a gripper (e.g., a pair of jaws, a chuck). The position and optional direction of the steering guide (300) relative to the end effector mounting fixture can be determined and tracked in real time.

[0185] An exemplary docking beacon (340) is shown in Figures 19-21. The orientation of the end effector mount can be adjusted in real time as the end effector mount approaches the handle portion (316) based on the relative orientation of the docking beacon (340) to the end effector mount, thereby enabling coupling without disturbing the orientation of the steering guide (300) already inserted into the target pipe. The level of pain caused by the shaking when the end effector mount (430) is coupled to the handle is severe (8 out of 10 on the pain scale). The tumor hardens the affected tissue, meaning that the damage from the tumor is transmitted to the nerves. The user cannot visually confirm that the end effector mount (430) is sufficiently aligned and free from displacement. This has been attempted by the inventors, and as a result, angular or linear displacement of the inserted placement tool (200) occurs when the end effector mount (430) (e.g., gripper (432)) closes its jaws. The docking beacon ensures that the end effector mounting fixture (430) is precisely aligned with the handle portion (316) (e.g., the grip locator). When the locking tool (430) engages, especially when the jaws of the gripper (432) close, movement of the inserted placement tool (200) is prevented.

[0186] 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), corrections to the approach direction are applied until the approach reaches the target. The closed feedback loop continuously checks and corrects the approach direction. The docking beacon (340) may be located at the proximal tip of the handle portion (316). The docking beacon may be positioned on the proximal handle portion (316) of the grip locator (330). The docking beacon (340) may be passive, active, or a combination of passive and active. The docking beacon (340) may include a passive docking beacon (340) and / or an active docking beacon. The docking beacon (340) may be detachable from the handle portion (316). The docking beacon (340) may be indestructible from the handle portion (316).

[0187] The passive docking beacon consists of a body with a predetermined geometric shape that is recognizable by a visual guidance robot system (e.g., one or more cameras, laser scanners). Visual guidance robot systems are well known in the art. The shape and orientation of the body allow for the identification of the orientation of the handle portion (316). The body of the passive docking beacon may be positioned at the proximal end, preferably the proximal tip, of the handle portion (316). It may be positioned proximal to the grip locator (330). The optical recognition system may be provided mounted on an end effector fixture.

[0188] The body of the passive docking beacon may comprise multiple spheres (346i-iv), as shown in Figure 19, for example. At least three spheres are required. The positions and spacing of the spheres are predetermined. The orientation of the handle portion (316) can be determined from the two-dimensional images of the spheres and their relative distances. The distance from the handle portion to the end effector mounting fixture can be determined from the two-dimensional images of the spheres and their diameters, which appear the same in any orientation.

[0189] The body of the passive docking beacon may include a two-dimensional shape (347) (e.g., a rectangular shape) as shown, for example, in FIG. 20. The rectangular shape has a predefined size and shape. The direction of the handle portion (316) can be determined from a two-dimensional image of the rectangle showing a structure cut according to the direction. The distance from the handle portion of the end effector fixture can be determined from a non-contact distance measurement device (e.g., a laser or ultrasonic rangefinder). If the optical recognition system is a laser scanner, a laser rangefinder may be incorporated.

[0190] The active docking beacon wirelessly transmits information that enables determination of the position and / or direction of the handle portion (316). This may include a solid-state gyroscope (3-axis). This may include a wireless transmitter (e.g., Bluetooth), a controller, and a replaceable or rechargeable power source. The approach angle of the end effector fixture can be adapted according to the orientation of the handle portion (316) transmitted by the active docking beacon. The distance between the end effector fixture and the handle portion (316) can be determined by a non-contact distance measurement device (e.g., a laser or ultrasonic rangefinder). An exemplary active docking beacon is shown, for example, in FIG. 21.

[0191] Another example of an active docking beacon is an array of positioning wireless transponders described elsewhere in this specification. The position of the transponder can usually be tracked in real time by a spatial transponder detector that can achieve an accuracy of less than a millimeter and less than a degree. The transp onder can receive power inductively or from a built-in power source such as a battery in the handle of the steering guide.

[0192] The handle portion (316) may or may be connected to the end effector mount by manual guidance. If the placement device is a robotic arm, this may be achieved in RA zero-gravity mode. In zero-gravity mode, the joints of the robotic arm are supported (e.g., by servos) to prevent arm collapse, and the orientation of the end effector mount can be manually guided by medical staff to near the handle portion (316) when the distal end of the placement tool (200) is already inserted into the target. Once the connection between the end effector mount and the handle portion (316) is made, the zero-gravity mode is deactivated and operations may be performed as described elsewhere herein. Since the RA operating in zero-gravity mode continues to record the orientation of the end effector mount, when the zero-gravity mode is deactivated, the RA can continue to be controlled to a therapeutic or simulation orientation by the controller and steering guide (300) without any intervention calibration operations.

[0193] Docking can be achieved by setting the orientation of the end effector attachment (430) on the radiotherapy treatment table to one of the treatment orientations, and attaching the end effector attachment (430) to the handle portion (316) of the steering guide (300) inserted into the patient. The steering guide (300) is introduced into the patient's body and positioned in the same location as during the simulation using laser light and imaging, and then the orientation of the robotic arm (400) is adjusted to the same orientation (treatment orientation) achieved during the simulation. The treatment orientation 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 orientation within the patient's body as during the simulation.

[0194] 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 with a fixed connection and relationship (i.e., direction and / or position) to both the effector shaft (310) and the handle portion (316). It may be straight, curved, or include one or more angled bends. It may be formed substantially from a rigid rod. The rod may be hollow or solid.

[0195] The transmission (314) may have a length (T) of 1 to 30 cm, preferably 10 to 25 cm, preferably 8 to 20 cm, depending on the type of tumor (see Figures 6 and 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 the effector shaft may adopt an angle gamma relative to each other (e.g., Figure 6A). For dimensions and angles suitable for various medical applications, please refer to Tables 2 and 2a.

[0196] The diameter may be uniform from the proximal to the distal end, or it may vary. For example, the diameter may increase towards the proximal part of the transmission and decrease towards the distal part. The change in diameter may be gradual. A smaller distal diameter increases the risk of trauma when entering the vagina, while an increase in diameter towards the proximal part improves the rigidity of the steering guide (300).

[0197] The steering wheel portion (316) may be continuous with the transmission (314). The transmission (314) may have a portion of its proximal length that is the same as the steering wheel portion (316). The steering guide (300) may have a diameter (for example, 0.3 to 3 cm, preferably 0.5 to 2 cm), for example, 2.5 to 3 cm of the proximal length of the transmission (314). The steering guide (300) can be reinforced by extending a larger diameter steering section (316) in conjunction with the proximal portion of the transmission (314). Reinforcement struts (317) may be positioned at the corner between the steering section (316) and the transmission (314) (for example, Figures 15, 15', 16, 17, and 17').

[0198] The distal portion (20) of the transmission (314) can have a smaller diameter (0.3-1 cm) to make it non-traumatic in terms of its diameter (non-traumatic when inserted into the vagina).

[0199] 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 on 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 Figure 6, possible exits for the guide strand passage (312) on the transmission are at the distal end (312, -b3), the middle section (312, -b4), or the proximal end (312, -b5). In Figure 7, the exit for the guide strand passage (312) is located at the distal end (312, -b3) of the transmission. In Figure 8, the exit for the guide strand passage (312) on the transmission is located at the proximal end (312, b5). In Figures 15, 17, and 18, the possible guide strand passage (312) exits the transmission at the lower intermediate section (312, -b4) of the transmission portion.

[0200] An inflatable transmission balloon (322) can be positioned toward the distal end (20) of the transmission (314), for example, as shown in Figures 9, 9', 16, 17, 17', 18, 26, and 26'. The inflatable transmission balloon (322) can be used to expand the vagina for radiotherapy, preferably to a known or fixed diameter. Furthermore, the transmission (314) can be concentrated, for example, within the vaginal passage (606). In its inflated state, it helps to position the vaginal passage (606) in a specified position and / or direction and / or diameter for radiotherapy treatment. The diameter of the transmission (314) may be small at the distal end (20), and the inflatable transmission balloon (322) allows the transmission (314) to enter the vaginal passage (606) in a narrower, less painful way. Inflation of the inflatable transmission balloon (322) expands the vaginal wall to accommodate it. The wall of the inflatable transmission balloon (322) can be made from 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) may have a limited maximum expansion size, thereby resisting expansion beyond the maximum expansion size (semi-compliant or non-compliant balloon). In other words, the inflatable transmission balloon (322) may be limited in expansion, and expansion reproducibly stops at the limited expansion size. Continuing to expand by applying hydraulic pressure beyond the limited expansion size will not result in further expansion. The limited expansion size is reproducible, for example, in one or more further treatment sessions. The reproducible limited expansion size ensures that the target is in the corrective position of a particular treatment posture, as expansion stops once the limited size is reached. The distance between the inflated balloon wall and the effector shaft is known and / or reproducible. In particular, when performing repeated treatments in a fractional treatment program, the limited expansion size reduces placement errors in subsequent treatment sessions.The limited maximum expansion size applies to non-expandable materials such as PET, non-compliant, or semi-compliant polyamides. This can be achieved by forming the balloon wall from the material. The inflatable transmission balloon (322) may have a maximum inflation diameter of 2.0 to 5 cm. Dimensions of the transmission balloon (322) and examples of medical applications are shown in Tables 2 and 2a.

[0201] The fluid connection to the inflatable transmission balloon (322) may be an expansion lumen (328) extending proximal (40) to the steering guide (300). This expansion lumen (328) may be located within the body of at least a portion of the transmission portion (314) (e.g., Figures 17, 17', and 18). This expansion lumen (328) is external and can be positioned parallel to at least a portion of the transmission portion (314). A fitting (329) (e.g., a Luer fitting) may be located at the proximal end of the expansion lumen (328) for connection to a pump. The inflatable transmission balloon (322) can be deflated after simulation and / or after each session or period of radiotherapy treatment by releasing an expansion fluid (e.g., saline or sterile water), thereby allowing the steering guide (300) to be pulled out.

[0202] The transmission balloon (322) can be inflated with saline or sterile water. Optionally, it may contain 0.5–4% contrast agent to make the transmission balloon visible on CT simulation images and / or images created prior to a radiotherapy session or period. Alternatively, the transmission balloon (322) may be provided with one or more imaging markers (e.g., to image visible wires (longitudinal, spiral, or circular)). One or more wireless localization transponders can be placed on the inflatable transmission balloon (322).

[0203] An inflatable transmission balloon (322) may be provided toward the distal end (20) of the transmission (314). Here, - Optionally, the inflatable transmission balloon (322) has a fixed maximum inflation diameter, and / or - Optionally, the inflatable transmission balloon (322) carries one or more imaging markers that are visualized by medical imaging, and / or - Optionally, an inflatable transmission balloon (322) carries one or more radio transponders for determining the position and / or orientation of the transmission (314) and / or effector shaft (310) by a spatial transponder detector.

[0204] 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 polyallylamide resin (e.g., Ixef (Solvay)), polyphenylsulfone (PPSU) glass fiber, aluminum (coated), bioceramics such as aluminosilicate, styrene acrylonitrile, or bioceramic polymer materials. The transmission (314) may be made from the same material as the handle portion (316). The proximal end of the transmission (314) may have the same diameter as the distal end of the handle portion (316).

[0205] The transmission (314) may be formed from an imaging-permeable material such as a polymer rod or tube. To facilitate manufacturing, the handle portion (316) may be formed from the same material. This can reduce imaging artifacts caused by the transmission (314) in the vaginal region (606). This will be explained in more detail below. Examples of suitable polymers include polycarbonate, polyphenylsulfone (PPSU), and fiber-reinforced polyallylamide resins (e.g., Ixef (Solvay)). Other materials that can be used for the handle portion Examples of materials include glass fibers, carbon fibers, bioceramics such as aluminosilicates, styrene acrylonitrile, bioceramic polymer materials, and biocompatible polymer rigid materials. Figures 7, 8, 8' and 15 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 an effector shaft (310) which may be formed from a hard metal such as titanium.

[0206] If the transmission (314) is not visible or not sufficiently visible to determine the position and / or orientation of the inserter, the transmission (314) may be accompanied by one or more imaging markers (350, a, b, c). This is useful when performing imaging using imaging tools for a linear accelerator. The steering guide (300), in particular the transmission (314), may be provided with one or more imaging markers that can be identified by medical imaging. The imaging markers may be fixed to the transmission (314) and may be provided, for example, on the inner surface, outer surface, or within the body of the transmission (314). The imaging markers may be made from a different material from the transmission (314), such as heavy metals such as platinum, platinum-iridium, tantalum, or tungsten. Figure 16 shows one or more imaging markers (350, a, b, c) placed on the transmission (314).

[0207] Polymer rods or tubes for the transmission (314) may have a larger diameter (e.g., 1 cm) compared to transmissions (314) made from stronger materials such as titanium or stainless steel. Polymer transmissions (314) can significantly contribute to reducing artifacts and obtaining superior images of the affected structure. Some imaging artifacts may originate from any imaging markers or effector shafts (310) present on the transmission (314), which may be made from titanium corresponding to the intracervical portion and any imaging markers placed on the insertor (204), but not as significant as when the entire steering guide (300) is made of metal (e.g., titanium, non-ferromagnetic steel, coated aluminum).

[0208] If made of polymer or ceramic material, the material of the transmission portion (314) may be mixed with a radiation-visible material such as barium sulfate for radiation visualization on simulation and control images performed before each radiation therapy session. For radiation visualization, the surface of the transmission portion may be covered with radiation-visible longitudinal circular helical markers made of metal (e.g., thin titanium or tantalum wire) or a material mixed with, for example, barium sulfate. If made of polymer material, the transmission portion may also contain radiation-visible markers within the structure.

[0209] An angle (alpha) (e.g., Figures 6 and 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 accessibility of the tube, e.g., the cervix or uterus. An angle (beta) (e.g., Figures 6 and 6') of 70 to 150 degrees can be formed between the handle portion (316) and the transmission (314), depending on the accessibility. An angle (gamma) (e.g., Figure 6A) can be formed between the effector shaft (310) and the plane formed by the transmission (314) and the handle portion (316) from 0 or -90 to +90°, depending on the accessibility. Refer to Tables 2 and 2a for dimensions and angles suitable for various medical applications.

[0210] [Table 2]

[0211] Table 2: Exemplary dimensions of elongated members and parts of steering guides and transmission balloons. Dimensions may exceed, but are not limited to, those shown for some of the subjects.

[0212] [Table 2a]

[0213] Table 2a: Examples of parts for elongated members, steering guides, and transmission balloons Symbolic dimensions. Dimensions may exceed, but are not limited to, those of the presented object.

[0214] As shown in Figures 26 and 26', the inserter (204) moves in response to the movement of the effector shaft (310), then the effector shaft (310) moves in response to the movement of the transmission (314), and finally the movement of the handle (316). By positioning the inserter (204), the position of the cervix (602), the tissues surrounding the cervix, and the uterus (604) can be adjusted and maintained in a fixed position. By inflating the inflatable transmission balloon (322), the tissues surrounding the vaginal passage (606) can also be adjusted and maintained in a fixed position.

[0215] Steering guide (300), particularly the effector shaft (310) and / or transmission (314) and / or steering wheel portion (316) and / or tractor A mission balloon may be present and may be equipped with one or more (e.g., two, three or more) positioning radio transponders (352, a, b, c) that can determine and track its position using a spatial transponder detector.

[0216] The terms "positioning radio transponder" and "transponder" are used interchangeably in this specification. Transponders are sometimes also known as beacon transponders. In Figure 16, three transponders (352, a, b, c) are fixed and mounted at different positions on the exterior or interior of the transmission (314). The same transponders (352a-c) also function as imaging markers (350a-c) as they are visible on the medical image.

[0217] A transponder is a device that emits electromagnetic pulses at a specific radio frequency detectable by a spatial transponder detector, and typically includes a number of spatially separated receivers (coils). The timing of the pulses detected by the number of spatially separated receivers in a position transponder reader allows for the precise determination of the transponder's position. Transponders are sometimes also known as beacon transponders. Transponders can inductively accept power. Transponders can be powered by an internal power source, such as a battery located in the steering guide's handle. If multiple transponders are present, each transponder may transmit signals at a different radio frequency. If at least three distinctly identifiable transponders are positioned at different locations on the steering guide (300), the orientation of the effector shaft (310) can also be determined. Examples of such systems are described, for example, in U.S. Patent Nos. 9,248,003B2 and 9,072,895.

[0218] The use of transponders reduces the need to align the effector shaft (310) and / or transmission (314) several times before radiotherapy treatment using medical imaging, thereby reducing exposure to imaging radiation.

[0219] The transponder enables real-time tracking of the effector shaft (310) and / or transmission (314) during the simulation. The transponder also enables real-time automatic guidance of the position and / or orientation of the effector shaft (310) and / or transmission (314) during treatment (e.g., by a robotic arm) to align with a reference pose determined during the simulation.

[0220] The transponder also allows for the manual guidance, modification, and fixing of the position and / or orientation of the effector shaft (310) in real time, according to position and orientation information captured by the spatial transponder detector. For example, in a closed feedback loop, the continuous input is the attitude of the steering guide (300), and therefore the effector shaft (310), determined by one or more (e.g., two, three, or more) position-determining wireless transponders, and the operator can be provided with guidance to manually match the attitude of the steering guide (300), and thus the effector shaft (310), with the attitude determined during the simulation. In this scenario, the steering guide (300) may be mounted on a manually controllable placement device by a handle portion (316) (e.g., a manually adjustable placement device with lockable passive joints, or a placement device that is a robotic arm operating in manual zero-gravity mode). The same transponder and manual control may also enable the capture and saving of the attitude of the steering guide (300), and thus the effector shaft (310), during the simulation.

[0221] According to one aspect: - At least a portion of the effector shaft (310) and / or one or more imaging markers supported thereby are visible by medical imaging, in particular by X-ray medical imaging and / or MR medical imaging. and / or - At least the distal portion of the transmission (314) and / or one or more imaging markers carried thereon are visible by medical imaging, in particular by radiographic or MRI imaging. and / or - The transmission (314) and / or effector shaft (310) are arranged with one or more radio transponders, and the position and / or orientation of the transmission (314) and / or effector shaft (310) is determined by a spatial transponder detector.

[0222] The steering guide (300) may be equipped with an image acquisition system (360). The image acquisition system (360) acquires an image from the distal tip (361) of the effector shaft (310), and as a result, the effector shaft (310) can be inserted into body tissue or into the slender member lumen (214) of the inserter (204) under the guidance of the acquired image. The image allows, for example, guidance for manual insertion into the inserter (204). This allows the target of the effector shaft (310) to be visualized during insertion, thereby reducing pain during insertion of the effector shaft (310). An example of a steering guide (300) equipped with an image acquisition system (360) is shown in Figure 32A.

[0223] The distal end (361) of the effector shaft (310) may be located with an image inlet port (364) into which light reflected from an object enters. An example of the image inlet port (364) is shown in Figure 32B. The image inlet port (364) may be covered by a transparent window or sealed. The transparent window may be a lens. An image sensor (e.g., CCD, CMOS) is provided, and the captured image is projected and converted into an electronic signal. The image sensor may be located at the distal end (361) of the effector shaft (310), or in the body of the effector shaft (310), or in the body of the transmission (314), or in an auxiliary unit (368). If the image sensor is far from the image inlet port (364), the light may be transmitted using a fiber optic bundle. If the image sensor is located in an auxiliary unit, a connector (366) located within the steering guide (300) may be configured to detachably connect to a cable (367) containing a bundle of optical fibers for transmitting image light from the steering guide to an auxiliary unit (368). An example of the auxiliary unit (368) is shown in Figure 32C. The cable (367) attaches it to the steering guide (300) via the connector (366).

[0224] The distal end (361) of the effector shaft (310) may be located with one or more optical exit ports (362) through which light emitted from a light source exits. An example of an optical exit port (362) is shown in Figure 32B. The light exiting the exit port (362) is used to illuminate an object. The optical exit port (362) may be covered with or sealed by a transparent window. The transparent window may be a lens. The light source may be located in the distal end (361) of the effector shaft (310), in the body of the effector shaft (310), in the body of the transmission (314), or in an auxiliary unit (368). If the light source is located away from the optical exit ports (362), the light may be transmitted using an optical fiber cable. If the light source is in an auxiliary unit, a connector (366) located in the steering guide (300) is detachably coupled to a cable (367) containing an optical fiber cable for transmitting illumination light from the auxiliary unit (368) to the steering guide. This is possible. An example of the auxiliary unit (368) is shown in Figure 32C. The cable (367) attaches it to the steering guide (300) via the connector (366).

[0225] Electronic components of the image acquisition system (360), such as one or more of the processor, memory, I / O ports, power supply, wireless interface, and control unit, may be located partially or entirely within the steering guide. Components not present in the steering guide (300) may be located in an auxiliary unit (368). Signals and / or power may be transmitted from the steering guide to the auxiliary unit (368) via cables (367). Images captured by the image sensor may be displayed on a display such as a screen, a virtual reality viewer, or any device capable of displaying images from electrical signals. Captured images may or may not be saved. Microcameras with an outer diameter of 1 mm, including illumination, are commercially available (e.g., Scoutcam).

[0226] Treatment is typically performed using a two-stage protocol. The first stage, called simulation, involves precisely positioning the target on a mobile treatment simulation table relative to imaging devices, usually while acquiring internal medical images of the target (e.g., via CT or MRI) in three dimensions. These medical images are used for treatment planning in the second stage. From the images, radiologists determine which tissue structures will receive high doses, low doses, sensitive structures, etc.

[0227] Treatment is typically performed using a linear accelerator that irradiates the patient with ionizing radiation for radiotherapy. Information obtained during the simulation is used to set many parameters of the linear accelerator, including the patient's position, head movement angle, beam intensity, beam energy, and, if present, the contour shape of the leaf collimator. The linear accelerator may also incorporate a low-resolution medical imaging device to rapidly acquire medical images of the target (e.g., by MRI or CT) to confirm the location of the tissue determined during the simulation.

[0228] Medical imaging devices (simulations) and linear accelerators are typically located in separate rooms.

[0229] The patient's position relative to the medical imaging device is recorded by marking a tattoo at one or more locations where the projected laser reference lines intersect, with the tattoo positioned in a known positional relationship to the medical imaging device. Treatment rooms containing linear accelerators are also equipped with devices that project a similar pattern of laser reference lines that intersect the linear accelerator at known locations. By aligning the tattoo with the laser lines, the position of the subject relative to the linear accelerator can be determined. The three-dimensional image recorded by the medical imaging device in one room can be later replaced with the volume used for radiation therapy by the linear accelerator in another room.

[0230] Before initiating radiotherapy, the patient is typically examined under anesthesia, and the elongated portion (210) of the intubator (204) is typically inserted into the target tube (e.g., the cervix) under anesthesia and positioned in place. The presence of the sliding limiter (220) is activated, for example, by suturing the proximal stopper (250) and / or by inflating the balloon assembly (230) and / or by expanding the stent (240).

[0231] Before the simulation, once the patient is lying on the simulation table, the effector shaft (310) of the steering guide (300) is introduced along the subsequent guide strand (218) and slidably inserted into the elongated member lumen (214). This step can be performed by the subject itself. If a transmission balloon (322) is present, it is inflated with water mixed with 0.5–4% contrast agent. The subject is then positioned and / or orienting itself. The patient is placed on a body support (e.g., a simulation bed or table) that is known to be adjustable to the imaging device. The patient may be asked to lie down in a comfortable position on the simulation table. This allows the patient to find the optimal position on the simulation table for all subsequent treatment periods. A contrast agent is usually injected intravenously to better visualize pelvic vascular structures, tumors, and lymph nodes. Once the location of the target is confirmed by the radiation oncologist, the target is given markings on its bare skin (e.g., tattoos, reflective markings) as described above to allow for precise positioning of the body relative to the body support, and a laser beam positioned along the patient's body axis and laterally is used during the radiotherapy treatment session. Medical imaging acquired during the simulation allows for the determination of 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 can be adjusted by the corresponding movement of the handle portion (316). The proper orientation and / or positioning of the elongated member (210) and / or effector shaft (310) and / or transmission portion allows for the optimal placement of tissues relevant to treatment and the determination of which to use as the reference position. The optimal position of the placement tool (200) can be determined during simulation, which is mainly performed using CT scans (less frequently using MRI, or a two-step process fusing MRI and simulated CT images). For example, if it is found that the cervix may be positioned too far posteriorly, a high dose of irradiation can be directed to the entire rectal volume, and the cervix can be gently moved to a more anterior position during the simulation using a placement device (e.g., manual or robotic arm). Thereafter, the same position is repeatedly reproduced in each treatment session. After the simulation, the tumor and all organs are plotted on each CT slice during the treatment phase. This allows for the prescription of therapeutic doses to each tumor tissue (cervix, uterus, bladder, lymph nodes, etc.) and prevents excessive doses from being delivered to healthy tissues (spinal cord, intestines, kidneys, etc.).

[0232] Calculations are typically performed by a computer to determine the direction, location, intensity, duration, and frequency of radiotherapy treatment, and are optimized considering the fixed positions of the elongated member (210) and / or effector shaft (310). After the simulation, the steering guide (300), effector shaft (310), and possibly the transmission section are removed along a subsequent guide strand (218), which can be performed by the subject. The subsequent guide strand (218) can be taped to the subject's skin, for example, one side of the patient's groin. The inserter (204) remains in place in preparation for the treatment phase, for example, the following day or week. The position of tissue structures is expected to have shifted before the actual treatment, for example, because they are not fixed to the pelvis, the bladder is empty or full, and the colon is empty or full.

[0233] Immediately before radiotherapy treatment (e.g., several hours or minutes), the subject is positioned relative to the radiotherapy head, using, for example, the aforementioned markings on the bare skin and axial and transverse laser beams, to receive the therapeutic ionizing radiation. The steering guide (300) effector shaft (310) is introduced along the subsequent guide strand (218) and slidably inserted into the elongated member lumen (214). This step can be performed by the subject themselves. In fact, patients immediately feel discomfort if they make sudden movements. More precise positioning of the patient on the treatment table is usually performed by aligning the pelvis to the pelvic position determined during simulation, with the assistance of medical imaging (e.g., provided by an X-ray imager positioned in relation to the radiotherapy head). The orientation and / or position of the elongated member (210) and / or effector shaft (310) are monitored by medical imaging (usually X-ray) and / or a transponder and can be adjusted by the movement of the corresponding handle portion (316). For example, a placement device (e.g., a manual device or a robotic arm) is used to align with a reference orientation. Once the orientation and / or position of the transmission portion is set, the treatment portion (one of several) by extracorporeal radiotherapy can be initiated. The position of the inserter (204) is fixed and maintained throughout the session or period. At the end of the treatment portion, if a transmission balloon (322) is present, it is deflated by a technician or nurse, and the effector shaft (310) of the steering guide (300) is removed along the subsequent guide strand (218). This can be done by the patient. The inserter (100) remains in place in preparation for the next radiotherapy treatment, for example, the following day or the following week. Such a radiotherapy treatment period is divided into 1 to 35 sessions.

[0234] As previously mentioned, the placement tool (200) may be equipped with a transponder to capture the orientation of the placement tool (200) in real time during simulation or treatment. The transponder may be mounted on the inserter (204) and / or the steering guide (300). On the steering guide, the transponder may be mounted on the effector shaft (310), and / or on or inside the transmission (314), and / or on or inside the handle portion (316), and / or on the inflatable transmission balloon (322) (if present).

[0235] The transponder enables real-time guidance of the placement tool (200) during treatment to align with a reference orientation determined during simulation. The guidance provided can be manual, semi-automatic, or automated by a robotic arm. The transponder enables real-time guidance, modification, and fixing 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, the 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, and guidance can be provided to match 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 on-site simulation or treatment.

[0236] Real-time guidance of the transponder may be manual, providing information (e.g., graphical, audible, force feedback) to guide the operator to manually move and / or fix the placement tool (200). In this scenario, the steering guide (300) may be mounted on a placement device (e.g., a robotic arm operating in manual zero-gravity mode) that is manually controllable by a handle portion (316). The same transponder and manual control may also enable the capture and saving of the attitude of the steering guide (300), and by extension, the effector shaft (310), during simulation.

[0237] The transponder's real-time guidance is automated, providing information to the robotic arm, which in turn allows the robotic arm's joints to automatically move the placement tool (200).

[0238] Real-time guidance may be semi-automatic, providing information to the robot arm and operator to enable partially automated and partially manual movement of the placement tool (200).

[0239] The transponders function considerably below the surface of the target. Not all transponders need to be placed inside the patient's body. Not all transponders that are placed on or inside the placement tool (200) need to be placed inside the body. For example, one or two transponders can be placed on or inside the placement tool (200) in the part that will be inside the patient's body (e.g., on the inserter (204), on the effector shaft (310), or stearing One or two transponders may be positioned outside the patient's body (for example, on or inside the distal portion of the transmission (314) of the steering guide (300)).

[0240] In certain prior arts, transponders can be implanted in the body to track the location of organs. This placement tool (200) avoids the need for implantation. The transponders are placed on or inside a part of the external placement tool (e.g., an inserter (204), a steering guide (300)) and are temporarily introduced into the body for only a few minutes during each period. These transponders track objects within the body, are placed on the objects, and are not implanted, with some (one or two) remaining outside the body to track said objects. Thus, there is no need to implant transponders in the target.

[0241] Wearable inserters facilitate the precisely reproducible placement of the tube and surrounding tissue, reducing the need to broaden the radiation beam to account for tissues that typically shift position between treatment areas. They also fix the tube and surrounding tissue in place during irradiation. In practice, safety margins can be reduced from centimeters to millimeters, significantly reducing radiation exposure to adjacent organs and tissues. For example, when the cervix is ​​treated, irritation to the bladder, rectum, intestines, and pelvic wall is reduced. Because the beam volume is more concentrated (i.e., reduced), the radiation dose can be increased during extracorporeal radiotherapy (conformal radiotherapy), avoiding the need for close-range irradiation. For example, in the case of a cervical tumor 4 cm high and 5 cm in diameter, if the classic safety margin is 16 mm, the volume treated with high doses is 380 cm³. 3 This is achieved. Using the placement tool (200), the cervix can be fixed and repositioned in the same position before each radiation period, and a narrower margin (e.g., 4 mm) can be implemented, resulting in a high-dose volume of 126 cm³. 3 It can be reduced to 1 / 3.3 of its original level. This has a very beneficial effect on reducing toxicity.

[0242] The wearable inserter eliminates the need to sedate patients before radiation therapy. This reduces patient trauma and minimizes the recurrence of trauma during each treatment period. The guide strand allows users (radiation oncologists, physicians, radiographers, and subjects) to easily locate and operate the steering guide from outside the subject. In gynecological applications, it eliminates the need for a microscope. Patients can also insert the steering guide themselves. The guide strand allows for repeated attachment and removal of the steering guide before and after fractional therapy. Access to the elongated member lumen (214) is possible even though the wearable inserter is instantaneously positioned in the situ of the cervix.

[0243] Furthermore, this specification provides a computer implementation method for improving the accuracy of site-specific radiotherapy for target body tissues that are the target of radiotherapy treatment, - To receive data regarding the following, o Position and / or orientation of the insertion tool (200) such that the inserter (204) is located inside the target pipe, A method is provided which includes outputting commands to a placement device (e.g., a robotic arm) to adjust the position and / or orientation of the placement tool (200) according to a reference orientation of the placement tool (200), thereby adjusting the position and / or orientation of the tube and body tissue, wherein the reference orientation is determined during a treatment simulation procedure.

[0244] Furthermore, this specification provides a computer implementation method for improving the accuracy of site-specific radiotherapy for target body tissues that are the target of radiotherapy treatment, - To receive data regarding the following, o Position and / or direction of the inserter (204) placed inside the tube, and / or o Steering guide (3 The position and / or direction of the effector shaft (310) of 00), A method is provided which includes 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 is determined during a therapeutic simulation procedure.

[0245] The position and / or orientation of the placement tool (200) and / or inserter (204) and / or effector shaft (310) may be determined from medical images taken immediately before (e.g., a few minutes or hours) the radiotherapy treatment, or from the position of the placement tool (200) and / or inserter (204) and / or effector shaft (310) and / or a transponder attached to the handle portion of the transmission or steering guide. The reference posture may be determined during the simulation of the treatment relative to the patient's structure (bones, pelvis). The radiotherapy treatment may be fractionated.

[0246] Furthermore, this specification provides a computer implementation method for improving the accuracy of site-specific radiotherapy for target body tissues that are the target of radiotherapy treatment. (a) Receiving data on a computer relating to the following: The position and / or orientation of the insertion tool (200) in which the inserter (204) is placed inside the target pipe is determined by the following:

[0247] • 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) A method is provided which includes outputting a real-time indication of the position and / or orientation of the placement tool (200) compared to a reference orientation of the placement tool (200) determined during the simulation procedure to a computer's graphical user interface.

[0248] Furthermore, this specification provides a computer implementation method for improving the accuracy of site-specific radiotherapy for target body tissues that are the target of radiotherapy treatment. (a) Receiving data on a computer relating to the following: o Position and / or direction of the inserter (204) placed inside the tube, and / or o Position and / or direction of the effector shaft (310) of the steering guide (300) located within the elongated member lumen (214) of the inserter (204), The position and / or orientation of the inserter (204) or effector shaft (310) is determined by the following:

[0249] • 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) Compared to the reference position of the inserter (204) and / or effector shaft (310) determined during the simulation procedure, The position and / or direction of the inserter (204), and / or A method is provided which includes outputting a real-time indication of the position and / or direction of the effector shaft (310) to a computer's graphical user interface.

[0250] Furthermore, computing devices or systems configured to perform the computer implementation methods described herein are also provided.

[0251] Also provided are computer programs or computer program products that, when executed by a computing device or system, have instructions causing the computing device or system to perform the computer implementation methods described herein.

[0252] Furthermore, a computer-readable medium storing the computer program described herein is also provided.

[0253] Furthermore, a computer-readable medium is also provided, which, when executed by a computing device or system, stores instructions causing the computing device or system to perform the computer implementation method described herein.

[0254] Furthermore, data streams representing the computer programs or computer program products described herein are also provided.

[0255] This specification provides a method for treating target body tissues that are targets of radiotherapy using site-specific fractionated radiotherapy. (a) Receiving data on a computer relating to the following: o Position and / or direction of the insertion tool (200) in which the inserter (204) is placed inside the pipe, and / or (b) Outputting computer commands to a placement device (e.g., a robotic arm) and adjusting the placement tool (200) according to the reference pose of the placement tool (200), thereby adjusting the position and / or orientation of the tube and body tissue to reproduce the position of the placement tool (200) during the treatment simulation procedure, (c) Maintain the position and / or orientation of the placement tool (200) during the duration of site-specific fractionated radiotherapy, (d) Remove the steering guide (300) and (e) Repeating steps (a) through (d) in one or more subsequent portions of site-specific fractionated radiotherapy.

[0256] This specification also provides a method for treating target body tissues that are targets of radiotherapy using site-specific fractionated radiotherapy. (a) Receiving data on a computer relating to the following: o Position and / or direction of the inserter (204) placed inside the tube, and / or o Position and / or direction of the effector shaft (310) of the steering guide (300) located within the elongated member lumen (214) of the inserter (204), (b) Outputting computer 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 the reference orientation of the inserter (204) and / or effector shaft (310) and / or transmission part (314), thereby adjusting the position and / or orientation of the tube and body tissue, and reproducing the position of the inserter (204) and / or effector shaft (310) and / or transmission part (314) as in the treatment simulation procedure, (c) Maintain the position and / or orientation of the intubator (204) during the duration of site-specific fractionated radiotherapy, (d) Remove the steering guide (300) and (e) Repeating steps (a) through (d) in one or more subsequent portions of site-specific fractionated radiotherapy.

[0257] This specification provides a method for treating target body tissues that are targets of radiotherapy using site-specific fractionated radiotherapy. (a) Determine the following: The position and / or orientation of the placement tool (200) and the inserter (204) are placed inside the target pipe, and the position and / or orientation of the placement tool (200) are 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 a real-time display of the position and / or orientation of the placement tool (200) compared to the reference orientation of the placement tool (200) determined during the simulation procedure to the computer graphical user interface, (c) Manually adjust the position and / or orientation of the placement tool (200) until it matches the reference orientation of the placement tool (200), (d) Maintain the position and / or orientation of the placement tool (200) during the duration of site-specific fractionated radiotherapy, (e) Remove the steering guide (300) from the positioning tool (200), and (f) Repeating steps (a) through (e) in one or more subsequent portions of site-specific fractionated radiotherapy.

[0258] This specification also provides a method for treating target body tissues that are targets of radiotherapy using site-specific fractionated radiotherapy. (a) Determine the following: o Position and / or direction of the inserter (204) placed inside the tube, and / or o Position and / or direction of the effector shaft (310) of the steering guide (300) located within the elongated member lumen (214) of the inserter (204), The position and / or orientation of the inserter (204) or effector shaft (310) is determined by the following: • 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) attached to the steering guide (300), (b) Compared to the reference orientation of the inserter (204) and / or effector shaft (310) determined during the simulation procedure. The position and / or direction of the inserter (204), and / or The real-time display of the position and / or direction of the effector shaft (310) is output to a computer's graphical user interface, (c) Manually adjust the position and / or orientation of the inserter (204) and / or the effector shaft (310) until it matches the reference orientation of the inserter (204) and / or the effector shaft (310), (d) Maintain the position and / or orientation of the intubator (204) during the duration of site-specific fractionated radiotherapy, (e) Remove the steering guide (300) and (f) Repeating steps (a) through (e) in one or more subsequent portions of site-specific fractionated radiotherapy.

[0259] A system may be provided comprising a placement tool (200) as described herein and a placement device as described herein, configured to adjust and fix the position and / or orientation of the handle portion (316) and thus the effector shaft (310). The placement device may be a robotic arm (400, 400a, 400b). The system may further comprise a processing unit (440).

[0260] The handle portion (316) may be configured to be attached to a placement device. The placement device is preferably a robotic arm.

Claims

1. A placement tool (200) for supporting the treatment of a target in an extracorporeal radiotherapy program that includes two or more extracorporeal radiotherapy treatment sessions, - Includes a steering guide (300) having a proximal end (40) and a distal end (20), the steering guide is - The rigid effector shaft (310) at the distal end (20) is configured to be inserted into the tube (602) of the object (50), or to be attached to an inserter (204) configured to be inserted into the tube (602) of the object (50), - Includes a rigid handle portion (316) positioned at the proximal end (40) in a fixed relationship with respect to the effector shaft (310) in order to control the position and / or direction of the effector shaft (310), - The placement tool (200) is configured to move and / or fix the tube (602) and the body tissue (610) for the extracorporeal radiotherapy treatment session. - The handle portion (316) is provided with a grip locator (300) configured to cooperate with the gripper (432) of the robot arm (400) in a positionally repeatable manner, and the gripper (432) has an open state and a closed state. The grip locator (300) is configured to be fixed within the gripper (432) in the closed state, and in this state, the movement of the fixed grip locator (300) relative to the gripper (432) is restricted and prevented, in the positioning tool (200).

2. The positioning tool (200) according to claim 1, wherein the grip locator (300) includes a pair of arms, and in the open position the arms are further apart than in the closed position.

3. The placement tool (200) according to claim 1 or 2, wherein the grip locator (300) includes one or more movement limiters configured to cooperate with one or more complementary movement limiter members of the closed gripper (432), thereby restricting and preventing the movement of the fixed grip locator (300) relative to the gripper (432).

4. The positioning tool (200) according to any one of claims 1 to 3, wherein the grip locator (300) includes one or more stopping members configured to cooperate with one or more complementary stopping members of the closed gripper (432).

5. The positioning tool (200) according to any one of claims 1 to 4, wherein the grip locator (300) includes one or more notches (334) and / or one or more protrusions and / or one or more corners (332) configured to cooperate with one or more complementary structures of the closed gripper.

6. The positioning tool (200) according to any one of claims 1 to 5, wherein the grip locator (300) includes one or more notches (334), each having a direction, and optionally the edges of the notches are chamfered.

7. The positioning tool (200) according to any one of claims 1 to 6, wherein the grip locator (300) includes one or more corners (332) positioned along the axial direction of the proximal end of the handle portion (316).

8. The grip locator (300) has at least one notch (334) and at least The placement tool (200) according to any one of claims 1 to 7, wherein both include one corner (332), and the at least one notch (334) and the at least one corner (332) have different relative directions, preferably perpendicular directions.

9. The placement tool (200) according to any one of claims 4 to 8, wherein at least one notch is provided within the longitudinal range of the aforementioned corner.

10. - A placement tool (200) according to any one of claims 1 to 9, - A system comprising the robot arm (400), wherein the closed gripper (432) is configured as a rotation and / or movement limiter that restricts and prevents the rotation and / or movement of the grip locator (300) fixed within the gripper (432) relative to the gripper (432).

11. A placement tool (200) for supporting the treatment of a target in an extracorporeal radiotherapy program that includes two or more extracorporeal radiotherapy treatment sessions, - Includes a steering guide (300) having a proximal end (40) and a distal end (20), the steering guide is - The rigid effector shaft (310) at the distal end (20) is configured to be inserted into the tube (602) of the object (50), or to be attached to an inserter (204) configured to be inserted into the tube (602) of the object (50), - Includes a rigid handle portion (316) positioned at the proximal end (40) in a fixed relationship with respect to the effector shaft (310) and configured to be coupled to an end effector mounting fixture (430) of the robot arm (400) in order to control the position and / or direction of the effector shaft (310), - The placement tool (200) is configured to move and / or fix the tube (602) and the body tissue (610) for the extracorporeal radiotherapy treatment session. - The positioning tool (200) is provided with a docking beacon (340) on the handle portion (316) configured to provide information regarding the position and, optionally, the direction of the steering guide (300) relative to the end effector mounting fixture (430) of the robot arm (400).

12. The placement tool (200) according to claim 11, wherein the docking beacon includes a passive docking beacon having a body of a predetermined geometric shape recognizable by the visual guidance system of the robot arm.

13. The docking beacon comprises a plurality of spheres, the placement tool (200) according to claim 12.

14. The deployment tool (200) according to any one of claims 11 to 13, wherein the docking beacon includes an active docking beacon configured to wirelessly emit information that enables the position and / or orientation of the handle portion (316) to be determined.

15. The placement tool (200) according to claim 14, wherein the docking beacon includes a solid-state gyroscope.

16. - A placement tool (200) according to any one of claims 11 to 15, - A robotic arm (400) positioned together with an end effector mounting fixture (430), - Includes at least one processor and memory, the robot arm (400) A processing unit (440) configured to control the movement of the - The processing unit (440) is configured to use the information to adjust the orientation of the end effector (430) in real time as the end effector (430) approaches the handle portion (316), and to connect the end effector mounting fixture (430) to the handle portion (316) without changing the orientation of the steering guide (300) which is already inserted into the target pipe.

17. The system according to claim 16, wherein the handle portion (316) of the placement tool (200) is provided with a grip locator (300) according to any one of claims 1 to 10, and the end effector mounting fixture (430) is a gripper (432) according to any one of claims 1 to 10.

18. A placement tool (200) for supporting the treatment of a target in an extracorporeal radiotherapy program that includes two or more extracorporeal radiotherapy treatment sessions, - Includes a steering guide (300) having a proximal end (40) and a distal end (20), the steering guide is - A rigid effector shaft (310) located at the distal end (20), - Inserting through the entrance to a tube (602) related to the body tissue (610) of the subject, or - A rigid effector shaft (310) is configured to perform repeated, removable insertion of an elongated member (210) of an inserter (204) having a proximal end (40) and a distal end (20) into an elongated member lumen (214), the elongated member (210) being inserted through an entrance to a tube (602) connected to the target body tissue (610), - Includes a rigid handle portion (316) positioned at the proximal end (40) in a fixed relationship with respect to the effector shaft (310) in order to control the position and / or direction of the effector shaft (310), - The placement tool (200) is configured to move and / or fix the tube (602) and the body tissue (610) for the extracorporeal radiotherapy treatment session. - The steering guide (300) is provided with an image acquisition system (360) configured to acquire an image from the distal tip (361) of the effector shaft (310), and a positioning tool (200) that allows the effector shaft (310) to be inserted into the inlet of the tube (602) or the elongated member lumen (214) under the guidance of the acquired image.

19. The placement tool (200) according to claim 18, wherein the distal tip (361) of the effector shaft (310) is arranged together with an image inlet port (364) into which reflected light enters.

20. The placement tool (200) according to claim 18 or 19, wherein the distal tip (361) of the effector shaft (310) is arranged together with one or more light exit ports (362) from which light emitted by a light source is emitted.

21. A placement tool (200) further includes the inserter (204).

22. - A placement tool (200) according to any one of claims 18 to 21, wherein the handle portion (316) of the placement tool (200) is provided with a grip locator (300) according to any one of claims 1 to 10, A system comprising: a robot arm (400) according to any one of claims 1 to 10, positioned with the end effector mounting fixture (430).

23. The system according to claim 22, wherein the handle portion (316) is provided with a docking beacon (340) according to any one of claims 11 to 17.

Images