Wearable insertion device for reproducible alignment of body tissue for external radiotherapy procedures

Abstract

A positioning tool (200) for assisting treatment of a subject in an external radiation therapy procedure comprising one or more external radiation therapy sessions, comprising: an insertion device (204) having a proximal end (40) and a distal end (20), the insertion device comprising: an elongated member (210) configured to be inserted through an entrance into a tube (602) connected to body tissue (610) of a subject and provided with an elongated member lumen (214) configured to receive a manipulation guide device (300) operating mechanism shaft (310); and a guide wire (218) for guiding the operating mechanism shaft (310) from outside the entrance of the tube into the lumen (214), wherein the guide wire (218) is at least partially disposed within the lumen (214) and is restrained at or towards the distal end (20) of the guide wire (218) to restrict or prevent the guide wire (218) from sliding in the proximal direction relative to the lumen (214), wherein the positioning tool (200) is configured to move and / or fix the tube (602) and body tissue (610) of the subject relative to an ionizing radiation therapy beam for the external radiation therapy sessions.

Description

Technical Field

[0001] This device and method relate to the field of fractionated radiotherapy. In particular, it relates to a wearable device that can move and fix body tissue relative to an ionizing radiation beam, such that the tissue's location is accurately reproduced in each cycle of an external radiotherapy procedure. Background Technology

[0002] Radiation therapy is a standard treatment for many patients with various cancers located around the pelvic region. Most of the structures surrounding the pelvic region (bladder, rectum, cervix, uterus, vagina) are not attached to the pelvic wall and can shift significantly from the day medical images of the treatment area are taken for treatment planning (treatment simulation) to the day of the first treatment via external radiation therapy (and the subsequent days that optionally form the duration of the entire radiation therapy program). In cases of such structural shift, external radiation therapy is less effective because the ionizing radiation is no longer aligned with the tumor target.

[0003] External beam radiation therapy is typically administered in fractions, meaning lower doses of radiation are delivered at more frequent intervals (e.g., daily) to allow surrounding tissue time to recover. Fractionated therapy can last 6–7 weeks, and organ movement within the pelvis is unpredictable throughout this period. Based on our own observations, the cervix can move up to 2.2 cm in each direction, requiring a large volume margin to be introduced around the original treatment area (i.e., cervical cancer), thus increasing the treatment volume and leading to a higher incidence of acute and late-stage side effects. Cervical movement between simulations and treatments, or between fractions, can be caused by the filling and emptying of the bladder and rectum and, in part, by respiratory movements and defecation. Therefore, patients are instructed to empty their rectum and fill their bladder before each fraction. This allows for a reduction in uterine displacement but does not prevent it in a reproducible manner. In fact, patients often cannot keep their bladders at the same level of fullness throughout the entire treatment duration (e.g., 28–30 fractions) because inflammation of the bladder near the end of radiation therapy prevents complete filling. In addition, emptying the rectum causes both the anterior and posterior rectal walls to aggregate within a high-dose isodose volume with a therapeutic margin of 16-20 mm around the cervix, resulting in the entire rectum being contained within the high-dose volume.

[0004] For several years, treatment techniques using conformal radiotherapy (multi-leaf collimators, 360° radiotherapy, CyberKnife, and Tomotherapy) have allowed for the local delivery of very high doses while very accurately protecting healthy organs surrounding the tumor. These techniques offer the greatest benefit if the movement of the target to be irradiated is minimized. Nevertheless, they do not overcome the problem of tissue movement from the simulation to the treatment and / or between fractionated sessions.

[0005] US 2017 / 312546 A1 describes a fixation system for the rectal cavity that monitors the dose from an ionizing radiation source to a region of interest (such as the prostate); however, this fixation system is not suitable for subjects to wear for extended periods of continuous treatment (6–7 weeks) and is not reproducible. US 2008 / 293994 A1 describes a brachytherapy delivery device and method; however, these devices and methods relate to a different area of ​​radiation therapy—brachytherapy—where the radiation source is positioned inside the body rather than externally. US 2008 / 097471 A1 describes systems, methods, devices, and apparatus for performing improved gynecological and urological procedures, particularly allowing simultaneous tissue cutting and removal from the target site. It is unrelated to external radiation therapy.

[0006] Therefore, there is a need to create systems that allow for the repeated fixation of tissue structures in the pelvic region to benefit from high treatment precision. Summary of the Invention

[0007] A positioning tool (200) is provided for assisting a subject in an external radiotherapy procedure comprising one or more external radiotherapy sessions, the positioning tool (200) comprising:

[0008] - An insertion device (204) having a proximal end (40) and a distal end (20), the insertion device comprising:

[0009] - An elongated member (210) configured to be inserted through an inlet into a tube (602) connected to the body tissue (610) of the subject, and having an elongated member cavity (214) configured to receive an operating mechanism shaft (310) of a manipulation guide (300); and

[0010] - A guide wire (218) for guiding the operating mechanism shaft (310) from outside the inlet of the tube into the inner cavity (214), wherein the guide wire (218) is at least partially disposed within the inner cavity (214) and is confined at or toward the distal end (20) of the guide wire (218) to limit or prevent the guide wire (218) from sliding relative to the inner cavity (214) in the proximal direction.

[0011] - A removable manipulation guide (300) having a proximal end (40) and a distal end (20), comprising:

[0012] - An operating mechanism shaft (310) located at the distal end (20) is configured to be repeatedly and removably inserted into the elongated member cavity (214) along the guide line (218), and

[0013] A handle (316) fixedly associated with the operating mechanism shaft (310) at the proximal end (40) is used to control the position and / or orientation of the operating mechanism shaft (310).

[0014] The operating mechanism shaft (310) includes a body having a guide line channel (312) for sliding along the guide line (218), the guide line channel (312) being at least partially disposed along the length of the body.

[0015] The positioning tool (200) is configured to move and / or fix the subject’s tubes (602) and body tissues (610) for the external radiotherapy procedure.

[0016] A positioning tool (200) is provided for assisting a subject in an external radiotherapy procedure comprising one or more external radiotherapy sessions, the positioning tool (200) comprising:

[0017] - An insertion device (204) having a proximal end (40) and a distal end (20), the insertion device comprising:

[0018] - An elongated member (210) configured to be inserted through an inlet into a tube (602) connected to the subject's body tissue (610), and having an elongated member cavity (214) configured to receive the operating mechanism shaft (310) of the manipulation guide device (300); and

[0019] - A guide wire (218) for introducing the operating mechanism shaft (310) from outside the inlet of the tube into the inner cavity (214), wherein the guide wire (218) is at least partially disposed within the inner cavity (214) and is confined at or toward the distal end (20) of the guide wire (218) to limit or prevent the guide wire (218) from sliding relative to the inner cavity (214) in the proximal direction.

[0020] The positioning tool (200) is configured to move and / or fix the subject’s tube (602) and body tissue (610) relative to the ionizing radiotherapy beam for use in external radiotherapy procedures.

[0021] The tube may be the subject's cervix and / or uterus and / or vaginal fornix material, and the body tissue may be tissue contained in the pelvic region, and the inlet to the tube may be the inlet to the tube inside the cervix or vaginal fornix material.

[0022] The elongated member (210) may be provided with at least one sliding limiting device (220) configured to reduce or prevent the elongated member (210) from sliding relative to the tube.

[0023] At least one sliding restraint device (220) may be an inflatable balloon assembly (230) including one or more inflatable balloons (231, -a to -h), or an inflatable stent (240), a distal protrusion (245), or a stop member (250).

[0024] The inflatable balloon assembly (230) may include one or more inflatable balloons (231, -a to -h), each having an inflatable balloon lumen (232) in fluid communication with an inflatable lumen (234) extending in the proximal (40) direction via an inflatable tube (236). The guide wire (218) may be the inflatable tube (236).

[0025] The positioning tool (200) may be equipped with at least two sliding limiting devices (220):

[0026] - A first sliding limiting device, comprising a stop member (250) disposed at the proximal end (40) of the elongated member (210) and configured to abut against the inlet of the tube, optionally wherein the stop member (250) is provided with one or more suture passages (252) for suturing to the inlet of the tube, and

[0027] - A second sliding limiting device, comprising a device disposed at the distal end (20) of the elongated member (210):

[0028] -The inflatable balloon assembly (230), or

[0029] -The distal protrusion (245), or

[0030] -The expandable support (240).

[0031] The guide line (218) may be attached to the cavity (214) in a non-removable or removable manner.

[0032] The guide line (218) may be a relaxation tube (237) configured to receive a stiffening tube wire.

[0033] At least a portion of the insertion device (204) or by one or more imaging markers thereon may be visible through medical imaging, particularly through X-ray medical imaging and / or through MR medical imaging.

[0034] and / or

[0035] - At least a portion of the elongated member (210) or by one or more imaging markers thereon may be visible through medical imaging, particularly through X-ray medical imaging and / or through MR medical imaging.

[0036] and / or

[0037] - The insertion device (204) or elongated member (210) may be equipped with one or more radio transponders for determining the position and / or orientation of the insertion device (204) and / or elongated member (210) in real time by means of a space transponder detector, or

[0038] - The elongated member (210) may not be visible by X-ray imaging.

[0039] The positioning tool (200) may also include a removable manipulation guide (300) having a proximal end (40) and a distal end (20), comprising:

[0040] - An operating mechanism shaft (310) located at the distal end (20) is configured to be repeatedly and removably inserted into the elongated member cavity (214) along a guide line (218), and

[0041] - A handle (316) fixedly associated with the operating mechanism shaft (310) at the proximal end (40) for controlling the position and / or orientation of the operating mechanism shaft (310).

[0042] The operating mechanism shaft (310) may include a body having a guide line channel (312) for sliding along a guide line (218), the guide line channel (312) being at least partially along the length of the body. The guide line channel (312) may be a groove or cavity in the body of the operating mechanism shaft (310).

[0043] The main body of the operating mechanism shaft (310) can be rigid, and the elongated member (210) can be flexible and become rigid by being inserted into the elongated member cavity (214) of the operating mechanism shaft (310).

[0044] The handle (316) can be configured to attach to a positioning device, which is configured to adjust and fix the position and / or orientation of the operating mechanism shaft (310).

[0045] Choose one of them

[0046] The handle (316) is provided with a grip positioning device (330), which is configured to cooperate with the end effector accessory of the positioning device for detachably, repeatedly and reproducibly attaching the handle (316) to the positioning device.

[0047] The removable manipulation guide (300) may also include:

[0048] -A transmission device (314) that connects the handle (316) to the shaft (310) of the operating mechanism.

[0049] - Optionally, an inflatable transmission device balloon (322) is disposed toward the distal end (20) of the transmission device (314), wherein:

[0050] -Optionally, the inflatable transmission device balloon (322) has a fixed maximum inflation diameter, and / or

[0051] Optionally, the inflatable actuation balloon (322) carries one or more imaging markers visible through medical imaging, and / or

[0052] Optionally, the inflatable transmission balloon (322) is equipped with one or more radio transponders for real-time identification of the transmission device (314) by a space transponder detector.

[0053] And / or the position and / or orientation of the operating mechanism shaft (310).

[0054] At least a portion of the operating mechanism shaft (310) and / or one or more imaging markers carried by the operating mechanism shaft (310) are visible by medical imaging, particularly by X-ray medical imaging and / or magnetic resonance MR medical imaging;

[0055] and / or

[0056] - At least the distal portion of the transmission device (314) and / or one or more imaging markers carried by the operating mechanism shaft (310) are visible by medical imaging, particularly by X-ray medical imaging or MR medical imaging;

[0057] and / or

[0058] - The transmission device (314) and / or the operating mechanism shaft (310) are provided with one or more radio transponders for determining the position and / or orientation of the transmission device (314) and / or the operating mechanism shaft (310) in real time by means of a space transponder detector.

[0059] The handle (316) of the control guide (300) may be provided with a docking beacon (340), which is configured to provide real-time information about the position and optional orientation of the control guide (300) to allow manual, semi-automatic or automatic docking guidance of the positioning device with the handle (316).

[0060] The tube (602) is moved by the positioning tool (200):

[0061] - Body tissue (608) connected to the tube (602) can be brought into the ionizing radiation beam emitted by the ionizing radiation treatment head (518) during an external radiotherapy treatment session.

[0062] or

[0063] - Body tissue (608) connected to the tube (602) can be moved away from the ionizing radiation beam emitted by the ionizing radiation treatment head (518) during an external radiotherapy treatment.

[0064] A system is also provided, the system comprising:

[0065] - Positioning tools (200) as described in this article;

[0066] - A positioning device for adjusting and fixing the position and / or orientation of the handle (316) and the operating mechanism shaft (310) of the positioning tool (200);

[0067] in

[0068] The handle (316) is configured to be detachably attached to the positioning device; and

[0069] The positioning device is a robotic arm. Attached Figure Description

[0070] Figure 1 An isometric view of the insertion device provided herein is depicted.

[0071] Figure 2A A longitudinal cross-sectional view of the insertion device provided herein is depicted, the insertion device being provided with guide lines for detachable attachment to an actuation guide device.

[0072] Figure 2B A longitudinal cross-sectional view of the insertion device provided herein is depicted, which is provided with a removable (detachable) guide line having a ball stop, and the insertion device is provided for detachable attachment to an actuation guide.

[0073] Figure 2C A longitudinal cross-sectional view of the insertion device provided herein is depicted, which is provided with a removable (detachable) guide with a threaded distal end, the insertion device being provided for detachable attachment to an actuation guide.

[0074] Figure 2D Depicting a threaded distal end Figure 2C Removable (detachable) guide wire.

[0075] Figure 3 Different elements of a combinable insertion device are depicted, including elongated members (A to D), proximal sliding restraints (a to b) or none (c), and distal sliding restraints (i to v), wherein the guide wire is a flexible wire; elongated members (G to J), proximal sliding restraints (g to j), wherein the guide wire is an expansion tube; elongated members (K to L), proximal sliding restraints (k to 1) or none (m), and distal sliding restraints (xi to xv), wherein the guide wire is detachably attached to the elongated members; and elongated members (M to O), proximal sliding restraints (n to 0) or none (p), and distal sliding restraints (xvi to xx), wherein the guide wire is a relaxation tube.

[0076] Figure 4 An enlarged view of the expansion tube (236) inside the expansion cavity (234) is shown.

[0077] Figure 5 The positioning tool (200) described herein is shown, having an insertion device (200) and a manipulation guide device (300); the insertion device is located in the cervical canal.

[0078] Figure 6An exemplary manipulation guide device provided herein is depicted, with an alternative placement having a guide line channel outlet.

[0079] Figure 6A Depicting along Figure 6 The line of sight (e) in the middle is the angle of observation γ.

[0080] Figure 7 and 8 Each depicts a control guide device with an integrated polymer handle and a transmission mechanism, and each has a different configuration of the guide line channel outlet of the control guide device.

[0081] Figure 9 A control and guidance device is described, which is equipped with an inflatable transmission balloon.

[0082] Figure 10 The diagram depicts a manipulation guide device in which the guide line channel is a slot; details of the slot's entrance are shown in... Figure 10A As shown in the image.

[0083] Figures 11 to 14 An alternative construction of the notch in the handle portion (316) of the control guide device is depicted.

[0084] Figure 15A Figure C shows a configuration of a control guide device having an integral polymer handle and a transmission device and having a handle portion (316) that includes a notch and a corner.

[0085] Figure 16 It shows the relationship with Figure 15 A similar maneuvering and guiding device is constructed, which additionally includes a transmission balloon.

[0086] Figure 17 It shows Figure 16 A longitudinal cross-sectional view of the maneuvering and guiding device.

[0087] Figure 18 It shows Figure 17 An enlarged view of the internal cavity.

[0088] Figures 19 to 21 Each device is shown to be equipped with a different docking beacon.

[0089] Figures 22 to 25 Different insertion devices located in the cervical canal are shown.

[0090] Figure 26 The positioning tool provided herein, including an insertion device, is located in the cervical canal and mounted on a manipulation guide, and movement of the manipulation guide changes the position of the cervix and uterus.

[0091] Figure 27 and 28 - An illustration of a positioning tool inserted into a tube, where different orientations (A and B) of the positioning tool change the position of body tissue.

[0092] Figure 29A and 29B Each is illustrated with composite medical images showing changes in the orientation of the insertion device recorded during the simulation, during the treatment, and before the start of exposure. Figure 29A This is a side view of the insertion device. Figure 29B This is an axial view of the insertion device.

[0093] Figure 30 It is a dose-volume curve representing the dose / volume distribution received by the structures of the rectum, bladder, and cervix when the cervix is ​​not fixed (a, b, c, respectively) or when the cervix is ​​fixed (a′, b′, c′). Detailed Implementation

[0094] Before describing the tools and methods of the present invention, it should be understood that the invention is not limited to the specific systems and methods or combinations described, as such tools and methods, and combinations, can certainly vary. It should also be understood that the terminology used herein is not intended to be limiting, as the scope of the invention will be limited only by the appended claims.

[0095] As used herein, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” include both singular and plural references.

[0096] As used herein, the terms “comprising,” “comprises,” and “comprised of” are synonymous with “including,” “includes,” “containing,” or “contains,” and are inclusive or open-ended, without excluding additional, unlisted members, elements, or method steps. It should be understood that the terms “comprising,” “comprises,” and “comprised of” as used herein include the terms “consisting of,” “consists,” and “consists of.”

[0097] The range of values ​​listed by endpoints includes all numbers and fractions that fall within the corresponding range, as well as the listed endpoints.

[0098] When referring to measurable values ​​such as parameters, quantities, durations, etc., the terms "about" or "approximately" as used herein are intended to cover variations of + / -10% or less, preferably + / -5% or less, more preferably + / -1% or less, and even more preferably + / -0.1% or less from the specified value, provided that such variations are suitable for implementation in the disclosed invention. It should be understood that the values ​​referred to by the modifier "about" or "approximately" are themselves specifically and preferably disclosed.

[0099] Given that the terms “one or more” or “at least one” are self-evident as one or more or at least one member of a group of members, by means of further exemplification, the terms particularly cover references to any one of the members, or references to any two or more of the members (e.g., any ≥3, ≥4, ≥5, ≥6 or ≥7 of the members, and up to all of the members).

[0100] All references cited in this specification are incorporated herein by reference in their entirety. In particular, the teachings of all references specifically mentioned herein are incorporated by reference.

[0101] Unless otherwise defined, all terms (including technical and scientific terms) used in this disclosure have the meanings commonly understood by one of ordinary skill in the art to which this invention pertains. Further guidance, including terminology definitions, is provided to better understand the teachings of this invention.

[0102] The various aspects of the invention are defined in more detail in the following paragraphs. Unless expressly indicated to the contrary, each aspect so defined may be combined with any other one or more aspects. In particular, any feature indicated as preferred or advantageous may be combined with any other one or more features indicated as preferred or advantageous.

[0103] Throughout this specification, references to "an embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described with respect to that embodiment is included in at least one embodiment of the invention. Therefore, the phrases "in one embodiment" or "in an embodiment" appearing in multiple places throughout this specification do not necessarily refer to the same embodiment, but may refer to the same embodiment. Furthermore, in one or more embodiments, particular features, structures, or characteristics may be combined in any suitable manner, as will be apparent to those skilled in the art based on this disclosure. Moreover, while some embodiments described herein include some but not others, features in other embodiments, combinations of features from different embodiments are intended to be within the scope of the invention and form different embodiments, as will be understood by those skilled in the art. For example, in the appended claims, any of the claimed embodiments may be used in any combination.

[0104] In the present description of the invention, reference is made to the accompanying drawings, which form a part of the invention, and which illustrate specific embodiments in which the invention may be practiced only by way of example. Reference numerals in parentheses or bold attached to the corresponding elements exemplify these elements by way of example only and are not intended to limit the corresponding elements. It should be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the invention. Therefore, the following detailed description should not be construed in a limiting sense, and the scope of the invention is defined by the appended claims.

[0105] The terms “distal” or “far-side” or “distal” and “proximal” or “proximal” or “proximal” are used throughout the specification and are generally understood in the art to mean the practitioner’s side toward (proximal) or away from (distal) the device. Thus, “proximal” means toward the practitioner’s side and therefore away from the subject’s side. Conversely, “distal” means toward the subject’s side and therefore away from the practitioner’s side.

[0106] The term "longitudinal" is generally understood in the art to mean the longer length along the treatment table or simulation table. It can be used to refer to the radiotherapy treatment table or simulation table itself, to devices that can be attached to the radiotherapy treatment table or simulation table, or to a subject lying on the radiotherapy treatment table or simulation table.

[0107] The term “lateral” is generally understood in the art to mean along the shorter length of the treatment table or simulation table, i.e., from one side to the other or from left to right. It can be used to refer to the radiotherapy treatment table or simulation table itself, or to a device that can be attached to the radiotherapy treatment table or simulation table, or to a subject lying on the radiotherapy treatment table or simulation table.

[0108] The term "superior" is understood to mean the area facing the subject's head. It can be used to refer to a radiotherapy table or simulation table, a device that can be attached to a radiotherapy table or simulation table, or a subject lying on a radiotherapy table or simulation table. The term "inferior" is understood to mean the area facing the subject's feet. It can be used to refer to a radiotherapy table or simulation table, a device that can be attached to a radiotherapy table or simulation table, or a subject lying on a radiotherapy table or simulation table.

[0109] This article provides a positioning tool for assisting subject treatment in external radiotherapy procedures. The external radiotherapy procedure includes at least one course or fractionation of external radiotherapy and / or simulated treatment. The positioning tool (200) includes an insertion device (204) having a proximal end (40) and a distal end (20) (e.g., Figure 1 , 2A (To 2D). The insertion device (204) includes 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 such that movement of the positioning tool (200) causes movement of the tube. The elongated member (210) is provided with an elongated member cavity (214) configured to receive the operating mechanism shaft (310) of the manipulation guide device (300) (e.g., Figure 6 The operating mechanism shaft (310) can be configured to engage with the elongated member (210) to transmit movement of the actuation guide to the elongated member (210). The operating mechanism shaft (310) can be further configured to stiffen at least a majority of the elongated member (210) when the elongated member (210) is flexible. The elongated member cavity (214) of the insertion device (204) can be configured to be repeatedly and detachably attached to the actuation guide (300) of the operating mechanism shaft (310). The insertion device (204) also includes a guide wire (218) for guiding the operating mechanism shaft (310) from outside the tube inlet into the cavity (214). The distal end (20) of the guide wire (218) is fixedly attached to the cavity (214).

[0110] The movement of the tube via the positioning tool (200) causes movement of the subject's body tissues relative to the external ionizing radiation beam, particularly relative to the beam intersection volume of the external ionizing radiation beam. The position and / or orientation (posture) of the positioning tool is adjustable and fixed for at least a portion of the treatment duration. The fixed posture of the positioning tool stably fixes the position of the body tissues relative to the ionizing radiation beam. Figure 27 and 28The invention is illustrated. Movement of the tube via the positioning tool (200) can align the subject's body tissue with the ionizing radiation therapy beam, for example, with a dose volume equal to that of the ionizing radiation therapy, as it has been defined during patient simulation under CT scan or MR. Alternatively, movement of the tube via the positioning tool (200) can move and / or fix the subject's body tissue away from the ionizing radiation therapy beam, for example, to protect the structure.

[0111] exist Figure 27 Figure A depicts a positioning tool (200) inserted into a tube (602) of the subject and body tissue (608) connected to the tube (602). By adjusting the orientation of the positioning tool (200) (Figure B), the position of the body tissue (608) can be stabilized, adjusted, and fixed relative to the ionizing radiation beam emitted by the ionizing radiation head, especially relative to the beam intersection volume (612) (e.g., isocenter). The beam intersection volume (612) has a constant position in Figures A and B. Figure 27 In Figure B, body tissue (608) is also the treatment target (610), which is brought into the beam intersection volume (612) to be exposed to ionizing radiation. The orientation of the positioning tool (200) can be recorded and reapplied in subsequent treatments of fractionated therapy.

[0112] exist Figure 28 In Figure A, a positioning tool (200) inserted into a tube (602) of the subject and body tissue (608) connected to the tube (602) are depicted. The positioning tool (200) is adjusted in position (…). Figure 28 Figure B) shows how the position of body tissue (608) can be stabilized, adjusted, and fixed relative to the ionizing radiation beam emitted by the ionizing radiation head, especially relative to the beam intersection volume (612) (e.g., isocenter). The beam intersection volume (612) has a constant position in Figures A and B. Figure 28 In Figure B, body tissue (608) is not the treatment target (610), and it is brought outside the beam intersection volume (612) to avoid exposure to ionizing radiation. The orientation of the positioning tool (200) can be recorded and reapplied in subsequent sessions of fractionated treatment.

[0113] Between simulations and treatments, or between treatment sessions, the degree of movement of the subject's internal organs or tissues varies. Figures 29A to 29B The images are shown below. Each image is a fused X-ray image of a subject undergoing a simulation and treatment for cervical cancer, in which the positioning tool (200) insertion device (204) described herein has been inserted into the cervical canal, with the simulation and images taken during the subsequent first treatment superimposed. The external margin of the irradiated volume (614) is indicated.

[0114] The first posture (A) of the positioning tool (200) insertion device (204) used in the simulation corresponds to the natural placement of tissues and organs and involves minimal active posture adjustment by the robotic arm. A second posture (B) of the positioning tool (200) insertion device (204) was recorded during the subsequent first treatment session before adjustment by the robotic arm. Significant differences exist between the first posture (A) and the second posture (B) due to internal movement of tissues and organs between treatment sessions (causing approximately 2.1 cm displacement of the insertion device (204) tip) and corresponding displacement in terms of the position of the treatment target. The new posture (B) has an external margin in the irradiated volume and will receive a much lower dose than calculated. This system and method correct for internal movement by adjusting the posture of the positioning tool (200) insertion device (204) by the robotic arm during treatment sessions to correspond to the posture recorded during the simulation, resulting in a significant reduction in toxicity.

[0115] The effect of positioning tools on reducing toxicity in adjacent structures Figure 30 As shown in Figure 43, this is a dose-volume histogram illustrating the relationship between the percentage of irradiated volume in each organ (rectum, bladder, cervix) and the dose received by the irradiated volumes of the rectum (a, a'), bladder (b, b'), and cervix (c, c'). This is calculated for external radiotherapy of the cervix when it is not placed (in its natural position) (a, b, c) and when it is placed using a positioning tool (a', b', c'). When the cervix is ​​the treatment target, the rectum (a, a') and bladder (b, b') are recipients of radiation toxicity. The margin in the current calculation is 16 mm (large margin) when the cervix is ​​not placed, and 5 mm when it is placed using a positioning tool.

[0116] For the rectum (a, a'), when the cervix was not positioned using a positioning tool, 50% of the rectal volume received a dose of 50 Gy (a 50 When the cervix was positioned using a positioning tool, 13% of the rectal volume received a dose of 50 Gy (a' 50 When the cervix was not placed, 30% of the rectal volume received a dose of 70 Gy (a 70 When the cervix was positioned using a positioning tool, 2.5% of the rectal volume received a dose of 70 Gy (a' 70 Therefore, when the cervix is ​​placed using a positioning tool, the dose volume received rectally is reduced from 50% to 13% (3.9-fold reduction) at 50 Gy and from 30% to 2.5% (12-fold reduction) at 70 Gy.

[0117] For the bladder (b, b'), when the cervix was not placed, 22% of the bladder volume received a dose of 50 Gy (b).50 When the cervix was positioned using a positioning tool, 10% of the bladder volume received a dose of 50 Gy (b' 50 When the cervix was not placed, 12% of the bladder volume received a dose of 70 Gy (b 70 When the cervix was positioned using a positioning tool, 3% of the bladder volume received a dose of 70 Gy (b' 70 Therefore, when the cervix is ​​positioned using a positioning tool, the dose volume received by the bladder decreased from 22% to 10% at 50 Gy (2.2-fold difference) and from 12% to 3% at 70 Gy (4-fold reduction).

[0118] For the cervix (c, c'), when the cervix was not placed, 100% of the cervical volume received a dose of 50 Gy (c). 50 When the cervix was positioned using a positioning tool, 100% of the cervical volume received a dose of 50 Gy (c'). 50 When the cervix was not placed, approximately 98% of the cervical volume received a dose of 70 Gy (c 70 When the cervix was positioned using a positioning tool, approximately 99.5% of the cervical volume received a dose of 70 Gy (c'). 70 Therefore, the positioning tool does not affect cervical volume / dose and results in a slight increase in cervical volume when receiving a higher dose of 70 Gy.

[0119] Figure 30 The results confirm that high doses can be delivered externally to the cervix while reducing complications caused by irradiation of the rectum and bladder. Traditionally, such high doses would require delivery via brachytherapy (an internal radiation source), a more targeted but complex and highly uncomfortable procedure requiring sophisticated interventions. In fact, most patients with cervical cancer who are inoperable due to vaginal or parametrial invasion would require brachytherapy needle implantation into invasive structures, which requires anesthesia and hospitalization. This is feasible only in a limited number of radiation therapy centers, making this treatment unavailable to all patients. This complex brachytherapy intervention can be avoided by using this positioning tool (200) to fix and place the cervix. Fixation and placement of the cervix allows for enhanced dose delivery to the cervix without excessive toxicity to surrounding tissues and will reduce the need for brachytherapy.

[0120] The tube (602) can be precisely moved and / or fixed by a positioning tool (200) to change and fix the position of the tube and body tissue relative to the external ionizing radiation therapy beam. The body tissue may be in the tube or may be a structure that moves as the tube moves (e.g., the prostate moving with the rectal canal or the uterus moving with the cervical canal).

[0121] The tube (602) of the subject is preferably a tube (channel) of a natural body structure, such as the cervical canal (602') and / or the uterus (604), the vagina (606), or a tube formed within the vaginal fornix (tumor or tumor recurrence). Figures 22 to 26 In this configuration, the positioning tool (200) is located within the cervical canal (602'). The canal can be formed surgically (e.g., in the vaginal fornix or a tissue mass such as the breast).

[0122] The subject's body tissue (608) associated with the tube refers to tissue that is 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 positioning tool (200)). In other words, the tube is mobilically connected to the body tissue. The body tissue may be part of the tube wall or a different tissue structure whose position and / or orientation are 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 insertion device (204) or the actuating mechanism shaft (310) in the cervix.

[0123] Body tissue (608) may be tissue that is the target of treatment (610) (e.g., a tumor) and will be brought into an external ionizing radiation therapy beam for exposure to the beam; accordingly, one or more targets for receiving treatment are positioned with high precision, thereby allowing for maximum dose and minimizing damage to healthy structures. Alternatively, body tissue may be tissue to be removed from the external ionizing radiation therapy beam to avoid exposure to the beam; accordingly, healthy tissue may be moved away from the target, thereby allowing for more isolated exposure.

[0124] Body tissue (608) can be tissue or organ tissue. Body tissue can be structures in the pelvic region such as the cervix, uterine body, rectum, bladder, and vagina, which can be moved by changing the position and / or orientation of the cervix and / or uterus and / or vagina. Body tissue can be structures in the region surrounding the uterus and vagina such as the rectum, lower colon, and bladder, which can be moved by changing the position and / or orientation of the uterus and vagina. It should be understood that the positioning tool can be used to treat multiple tissues located near the duct.

[0125] During the simulation under medical imaging, the tube (602) can be accurately positioned or moved by the positioning tool (200) to align with body tissue relative to an external ionizing radiation therapy beam, and in particular relative to a position reference, and the orientation of the positioning tool (200) is recorded, which is used for subsequent treatment.

[0126] Radiation therapy is delivered to the subject while the tube is held in one or more treatment positions. One or more treatment positions can be reproduced in one or more subsequent treatment sessions. The system allows body structures that can change shape or position between treatment sessions to be brought to a known, well-defined location and stabilized during each treatment session.

[0127] For example, during each radiotherapy session, when the cervical canal is placed in the same spatial position relative to the pelvic bone or the radiotherapy machine, spontaneous cervical movement completely disappears, and in order to account for spontaneous cervical displacement, the volume to be irradiated around the cervix can be significantly smaller, and the safety margin around the cervix can be reduced from 2 cm to 3-4 mm.

[0128] The systems, localization tools, and methods described in this article can be used to treat one or more tumors present in body tissues.

[0129] Typically, the movement of the ionizing radiation head causes the different ionizing radiation beam directions to intersect during the treatment session, thereby minimizing damage to surrounding tissues. The beam intersection volume is the volume in which different ionizing radiation beam directions intersect during an external radiation therapy session. The simulated beam intersection volume is the volume in which different simulated ionizing radiation beam directions intersect during a simulated external radiation therapy session. The (simulated) beam intersection volume typically coincides with the subject's tissue target (e.g., a tumor).

[0130] In the case where a radiotherapy apparatus (510) is equipped with an ionizing radiation treatment head (518) rotating about a single axis, the beam intersection volume is also referred to as the isocenter, which is the center of rotation of the ionizing radiation beam emitted by the ionizing radiation treatment head (518) during an external radiotherapy session. The isocenter is well known in the art; see, for example, http: / / ozradonc.wikidot.com / isocentre-of-the-linac. Apparatuses with isocenters (linear accelerators (linacs)) are manufactured, for example, by Varian. The simulated isocenter is the center of rotation of the ionizing radiation beam emitted by the ionizing radiation treatment head (518) during a simulated external radiotherapy session.

[0131] In other systems (such as Cyberknife), the radiotherapy device (510) is equipped with an ionizing radiation treatment head (518) mounted on a robotic arm with three or more degrees of freedom, which provides directional control of the ionizing radiation beam about more than one axis. The beam intersection volume is the volume in which the different directions of the ionizing radiation beam emitted by the ionizing radiation treatment head (518) intersect during an external radiotherapy session. The simulated beam intersection volume is the volume in which the different directions of the ionizing radiation beam emitted by the ionizing radiation treatment head (518) intersect during a simulated external radiotherapy session.

[0132] External radiation therapy (EPR) procedures refer to one or more courses of radiation therapy delivered to a subject's treatment site via an external radiation source (e.g., a linear accelerator optionally equipped with a multi-leaved collimator, a tomotherapy system, or any ionizing radiation source that moves around the patient, such as in the Cyberknife system). Treatment may include one or more courses or fractions. In the case of multiple fractions, the total dose is divided into multiple smaller doses, delivered over time at multiple intervals (fractions). Typically, for the treatment of cervical cancer, the duration is 28-32 fractions, with each fraction delivering a dose up to 2.6 Gy to the tumor. With fractionated treatment, healthy cells around the treatment site are given time to recover. Systems can also be used to deliver treatment at high doses / fractions over several fractions as enhancement or as palliative therapy in cases of bleeding, for example, five 6 Gy fractions or five 4 Gy fractions as enhancement or five 7 Gy fractions as palliative therapy delivered to the tumor.

[0133] A typical radiotherapy procedure consists of a simulation phase and a treatment phase. The simulation phase involves acquiring internal medical images (typically three-dimensional) of the subject (e.g., via CT or MRI) while the subject is precisely aligned with a movable treatment simulator relative to the imaging device. These images are used to plan subsequent external radiotherapy. The radiologist uses the images to determine which structures will receive higher doses, which will receive lower doses, sensitive structures, the number of treatment sessions or fractions, and so on. The treatment phase, as shown above, exposes the subject to ionizing radiation.

[0134] The elongated member (210) of the insertion device (204) has a proximal end (40) and a distal end (20). The elongated member (210) can be rigid (non-flexible). The elongated member (210) can also be flexible, which allows for better tolerance of the body to the elongated member (210), which can remain in situ in the tube for up to 2-3 months during the fractionated treatment process.

[0135] The elongated member (210) is sized for insertion into a catheter, particularly in cervical and / or uterine and / or vaginal vault resections. The elongated member (210) can have a length of 1 to 10 cm. When the elongated member (210) is configured for positioning in the cervix and / or uterus, it can have a length of 1-8 cm and a maximum outer diameter of 3-8 mm. When the elongated member (210) is configured for positioning in a vaginal vault resection, it can have a length of 1-5 cm and a maximum outer diameter of 3-8 mm. The diameter of the elongated member (210) can be uniform from proximal to distal or can vary. For example, the diameter can be larger towards the proximal portion and smaller towards the distal portion. The variation in diameter can be gradual. The variation in diameter can be gradual across the length of the elongated member (210). A smaller distal diameter is more non-invasive when entering the vagina, and a larger diameter towards the proximal portion improves the stiffness of the elongated member (210). For preferred dimensions for various medical applications, see Tables 2 and 2a.

[0136] The operating mechanism shaft (310) can be configured to cooperate with the elongated member (210) to transmit movement of the operating guide to the elongated member (210).

[0137] The elongated member (210) may be provided with an elongated member cavity (214). The elongated member cavity (214) is open at the proximal end (40) to allow slidable insertion of the operating mechanism shaft (310) of the manipulating guide device (300) prior to treatment. The elongated member cavity (214) may be open or closed at or toward the distal end (20). When it is open, it may provide a discharge passage (270) or outlet port (272) or threaded channel (272, -c) for a removable guide wire (218).

[0138] The actuation guide (300) attached to the insertion device (204) or the elongated member (210) is rigidly attached. The rigid attachment minimizes the clearance or backlash between the insertion device (204) and the handle portion (316) of the actuation guide (300).

[0139] The distal tip of the elongated member (210) can be non-invasive (e.g., having rounded edges, dome-shaped, and not causing incisions). The elongated member (210) can have a circular profile perpendicular to its longitudinal axis. The elongated member (210) can include a substantially cylindrical form. The elongated member (210) can be provided with one or more fins. Fins are protrusions extending outward from the surface of the elongated member (210). The fins also extend in the longitudinal direction. Their function is to better secure the elongated member (210) to the inner wall of a tube (e.g., the cervix) to prevent it from rotating during operation using a manipulator. Preferably, one or more fins are disposed within the proximal half (40) of the elongated member (210), for example, within 2-4 cm of the proximal end (40).

[0140] The elongated member (210) can be a rigid tube. The elongated member (210) can also be a flexible tube. One advantage of a flexible tube is that it is more comfortable for the subject when worn for the duration of treatment (e.g., several weeks). The walls of the elongated member (210) can be made of any biocompatible material such as a polymer. Examples of suitable materials include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, polyurethane, or silicone. Examples of materials used to form the rigid elongated member (210) include polycarbonate, PEEK, carbon fiber, and fiber-reinforced polyacrylamide resin (e.g., Ixef (Solvay)). Examples of materials used to form the flexible elongated member (210) include polyamide, polyimide, polyurethane, or silicone.

[0141] Typically, a simulated treatment is first performed under CT, PET-CT, or MRI scans. Treatment may then involve acquiring one or more X-ray images in a treatment room. Preferably, the elongated member (210) is made of a material compatible with medical imaging, such as CT or MRI. This material may or may not be visible on the medical images. Examples of materials not visible in CT or CT / PET scans include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, polyurethane, or silicone. To make it visible under CT, PET / CT, the material may be mixed with a low percentage of barium sulfate. Non-examples of materials visible in MRI scans include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, polyurethane, or silicone. The orientation (position and / or orientation) of the elongated member (210) can be determined directly from medical images of the elongated member (210) under MRI or with barium sulfate masking (under CT or PET-CT). Examples of materials not visible in CT and CT / PET scans include polycarbonate, PEEK, carbon fiber, polyamide, polyimide, and silicone. Where it is invisible or not sufficiently visible to determine the location and / or orientation of the insertion device, the elongated member (210) may be provided with one or more imaging markers. This is helpful when performing imaging using imaging tools with a linear accelerator.

[0142] The insertion device (204), particularly the elongated member (210), may be provided with one or more imaging markers (206) that can be recognized by medical images. Figure 1 In this embodiment, a pair of imaging markers (206) are fixed to the outer surface of the elongated member (210). The imaging markers (206) can be identified by medical images. The imaging markers (206) can be fixedly associated 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) can be protrusions or indentations. They can be made of the same material as the elongated member (210) and can be visible on medical images due to size differences. The imaging markers (206) can be made of materials different from those of the elongated member (210), such as heavy metals like platinum, platinum-iridium, tantalum, tungsten, or low-density metals like titanium, coated aluminum, etc.

[0143] The insertion device (204), particularly the elongated member (210), may be equipped with one or more (e.g., two, three, or more) location-determining radio transponders (260), the positions of which can be determined and optionally tracked using a spatial transponder detector. The terms location-determining radio transponder and transponder are used interchangeably herein. A transponder is sometimes referred to as a beacon transponder. Figure 1 In the middle, three transponders (260, a, b, c) are set to be fixed at different positions to the outer surface of the elongated member (210).

[0144] A transponder (260) is a device that emits electromagnetic pulses at a specific frequency detectable by a spatial transponder detector—typically comprising multiple spatially separated receivers (coils). The timing of the pulses detected by the multiple spatially separated receivers in a position transponder reader allows for accurate determination of the transponder's location. The transponder (260) can inductively receive electrical power. In the presence of more than one transponder, each transponder can emit signals at a different frequency. The orientation of the insertion device (204) can also be determined when at least three individually identifiable transponders (260, a, b, c) are positioned at different locations on the insertion device (204). Examples of such systems are described, for example, in US 9,248,003 B2 and US 9,072,895. The use of transponders reduces the need to align the insertion device (204) before radiotherapy using medical imaging, thus reducing exposure to imaging radiation.

[0145] According to one aspect:

[0146] - At least a portion of the insertion device (204) or one or more imaging markers carried by the insertion device (204) are visible by medical imaging, particularly by X-ray medical imaging and / or by MR medical imaging.

[0147] and / or

[0148] - At least a portion of the elongated member (210) or one or more imaging markers carried by the insertion device (204) are visible by medical imaging, particularly by X-ray medical imaging and / or by MR medical imaging.

[0149] and / or

[0150] The insertion device (204) and / or elongated member (210) are provided with one or more radio transponders for determining the position and / or orientation of the insertion device (204) and / or elongated member (210) by means of a space transponder detector.

[0151] A guide wire (218) is at least partially disposed within the cavity (214) of the elongated member and emerges therefrom at its proximal end. The operating mechanism shaft (310) of the actuating guide device (300) includes a guide wire channel (312) for receiving the guide wire (218). The guide wire channel (312) may be an inner cavity within the operating mechanism shaft (310) or a longitudinal groove on the surface of the operating mechanism shaft (310). The guide wire (218) is restricted at or toward its distal end (20) to limit or prevent slippage of the guide wire (218) relative to the cavity (214) in the proximal direction. This allows tension to be applied to the guide wire (218) in the proximal direction without releasing or moving the guide wire (218). The guide wire channel of the operating mechanism shaft (310) may be passed through by the proximal end of a guide wire trailing externally and reliably guided into the cavity (214) of the elongated member. The guide wire allows for repeatable installation and removal of the manipulator before and after simulated and / or radiation therapy. Although the lumen (214) of the elongated member is located in situ, for example in the cervix, access to the lumen (214) of the elongated member remains feasible.

[0152] The guide wire (218) may be a flexible rope (219) (e.g., composed of one or more strands) or an expansion tube (236) or a relaxation tube that will be stiffened by a stiffening tube wire. The outer diameter of the guide wire (218) is smaller than the inner diameter of the operating mechanism shaft (310). Its dimensions are designed to pass through the guide wire channel (312). The guide wire (218) has a narrow cross-sectional profile, such as 0.1 to 2.5 mm (flexible rope), or 1 to 2.5 mm (expansion tube), or 1 to 5 mm (relaxation tube). It has tensile strength to resist the tension applied to the operating mechanism shaft (310) of the actuating guide device (300) when it is inserted into the elongated member cavity (214). It may be non-expandable in the longitudinal direction. An example of the guide wire (218) as a flexible rope (219) is... Figure 1 As shown in 2A, 2B, 2C, and in Figure 3 As shown in Figures A, B, C, D, E, F, K, L, a, b, c, d, e, f, k, l, m.

[0153] The guide wire (218) may be non-removably (e.g., permanently) attached to the insertion device (204) or may be detachably attached to the insertion device (204). In the case where the guide wire (218) is detachably attached, preferably, such a guide wire is a flexible cord (219).

[0154] For example, during the molding production of the elongated member (210), a non-removable attachment to the insertion device (204) can be achieved by using an adhesive and by knotting the attachment to the support (213). The distal end of the guide wire (218) is preferably fixedly attached to the cavity (214) of the elongated member, preferably to the distal end of the cavity (214). An example of a non-removably attached guide wire (218) is shown in... Figure 2A As shown in, and in Figure 3 The figures A, B, C, D, G, H, and I are shown.

[0155] The guide wires (218, 219) are detachably attached to the insertion device (204) to allow both of the following:

[0156] - When the guide lines (218, 219) are present, the operating mechanism shaft (310) is reliably guided into the cavity (214) of the elongated member;

[0157] - When the guide wires (218, 219) are removed (disassembled), the close-range radiotherapy applicator is inserted into the cavity (214) of the elongated member.

[0158] There are situations where treatment begins using an external radiotherapy procedure and subsequently requires brachytherapy. Brachytherapy is well known in the art and is a process of treating a target using an internal ionizing radiation source. The radiation source is housed in a sealed capsule at the end of a flexible cable wound within a breech-loading chamber. When needed, the cable, with a certain thrust, is delivered from the breech-loading chamber into a delivery tube connected to a brachytherapy applicator at the treatment target. During treatment, the radiation source is held in place by or within the brachytherapy applicator and subsequently withdrawn into the breech-loading chamber. An in-situ elongated member (210) can be used as a conduit allowing the introduction of the brachytherapy applicator. With the elongated member (210) already placed near the target, the guide wire (218) is removed and the applicator is introduced into and held within the lumen (214) of the elongated member for irradiation of the target.

[0159] In cases where the guide lines (218, 219) are detachably attached to the insertion device (204), they are typically flexible ropes (219).

[0160] According to one example, the detachable guide lines (218, 219) are flexible ropes (219) having an anchored end (219, b) provided with a stop anchor (219, c). An outlet port (272, -a, -b) may be provided at the distal end (20) of the elongated member cavity (214). The guide lines (218, 219) are configured to pass through a proximal inlet (214, a) of the elongated member cavity (214), along the elongated member cavity (214) in the distal direction, through the distal outlet port (272, -a, -b), and return in the proximal direction to the proximal end of the insertion device (204). The guide lines (218, 219) have an anchored end (219, b) and a free end (219, a). The anchored end (219, b) exits from the outlet port (272, -a, -b). An anchoring end (219, b) is provided with a stop anchor (219, c). The stop anchor (219, c) is configured to engage with a reciprocating stop (254) on the insertion device (204), for example, on the elongated member (210) or the stop member (250). The reciprocating stop (254) can be a channel. The reciprocating stop (254) is located at the proximal end of the insertion device (204), which can be accessed by a specialist when the insertion device (204) is in place. The free end (219, a) exits from the proximal inlet (214, a) of the cavity (214) of the elongated member. The free end (219, a) is able to pass unrestricted through the proximal inlet (214, a), the outlet port (272, -a, -b), and the reciprocating stop (254) of the cavity (214) of the elongated member.

[0161] Tension applied to the free end (219, a) of the guide wire (218) causes the stop anchor (219, c) to engage with the reciprocating stop device (254), thereby preventing the guide wire (219) from sliding within the elongated member cavity (214). Tension applied to the anchoring end (219, b) of the guide wire (219) causes the guide wire (219) to slide within the elongated member cavity (214); the free end (219, a) passes through the proximal inlet and outlet ports (270, -a, -b, -c) of the elongated member cavity (214) and the reciprocating stop device (254) and is eventually removed from the insertion device (204). An example of a guide wire (218) detachable together with the stop anchor (219, c) is shown in Figure 2B As shown in, and in Figure 3 The figures are shown in E, F, d, e, and f.

[0162] According to another example, the detachable guide wires (218, 219) are flexible cords (219) with a threaded (219, d) distal end. The elongated member cavity (214) may be provided with a reciprocating threaded channel (272, -c) at the distal end (20). Axial rotation of the flexible cord (219) in one direction allows the threaded (219, d) distal end of the guide wires (218, 219) to engage with the reciprocating threaded channel (272, -c) of the insertion device (204), thereby attaching the elongated member (210). Rotation in the other direction releases the flexible cord (219) from the elongated member (210). Examples of guide wires (218) with detachable threaded portions (219, d) are shown in Figures 2E, 2F, and... Figure 3 It is shown in Figure K.

[0163] According to another example, the detachable guide wires (218, 219) are flexible cords (219) that are removable by applying a tensile force exceeding a certain threshold. The tensile force can be in the range of 1 to 3 kg. In one example, the flexible cord (219) has a breakable portion (219, e) at its distal end, where it is attached to the insertion device (204), particularly to the elongated member (210). In another example, the flexible cord (219) is attached to the insertion device (204) by a coupling that is torn off from the insertion device (204). An example of a guide wire (218) with a breakable portion (219, e) is... Figure 3 As shown in Figure L.

[0164] The guide wire (218) serving as a flexible cord (219) can be made of any suitable material, preferably a non-ferromagnetic material such as nylon or other polymeric materials, or a metal such as nitinol. The guide wire (218) serving as an expansion tube can be made of any suitable material, preferably a non-ferromagnetic material such as a polymer (e.g., polyamide) or a metal (e.g., nitinol). The guide wire (218) serving as a relaxation tube can be made of any suitable material, preferably a non-ferromagnetic material such as a polymer (e.g., polyamide). The guide wire (218) may contain or be coated with an antibacterial agent; examples of antibacterial agents include silver particles, erythromycin, or other antibiotics. Preferably, the guide wire (218) is made of a radio-transparent material. Preferably, the guide wire (218) is made of an MRI-compatible and biocompatible material. The distal end of the guide wire is preferably attached in a fixed association to the lumen (214) of the elongated member, preferably to the distal end of the lumen (214).

[0165] The guide wire (218) can be an expansion tube (236), which is a tube having an inner cavity in fluid communication with a distal sliding restraint device (220), which is an inflatable balloon assembly (230) – see below. The inner cavity of the expansion tube (236) can allow fluid (e.g., liquid, saline) to pass through to inflate one or more balloons of the inflatable balloon assembly (230). An example of a guide wire (218) as an expansion tube (236) is shown below. Figure 3 The graphs G, H, J, h, i, j Figure 4 As shown in Figures 24 to 26. The elongated member (200) may be provided with a coilable or self-expanding cylinder (e.g., a metal mesh 240) surrounding the distal outer side. This allows the practitioner to open the metal mesh within the tube (e.g., within the uterus (604)) by inflating the balloon (the balloon expands the mesh) or by removing a sliding member (a self-expanding support) around the mesh. The expandable balloon assembly (230) allows for blocking the movement of the elongated member within the uterus. As the tumor shrinks, the sutures used to attach the insertion device to the cervix may loosen over time. The presence of a distal sliding restraint device (220) as part of the expandable balloon assembly (230) prevents the elongated member (210) from sliding downwards from the uterus (604).

[0166] The guide wire (218) can be a relaxation tube (237), which is a tube having an inner cavity (238) configured to receive a stiffening guide wire. The relaxation tube (237) is more flexible without the stiffening guide wire and less flexible (stiffer, with greater thrust) when the stiffening guide wire is inserted into the inner cavity (238). An example of a guide wire (218) as a relaxation tube (237) is shown in Figure 3The stiffening cannula (237) is more flexible than the relaxation cannula (237). The stiffening cannula can be a metal wire or a polymer wire. When the subject wears the insertion device (204), there is no stiffening cannula in the relaxation lumen (238). The relaxation cannula (237) without the stiffening cannula allows for more comfortable wearing of the insertion device because the relaxation cannula (237) has increased flexibility and conforms better to the subject's shape changes during wear. The stiffening cannula is inserted along the lumen (238) of the relaxation cannula (237) before the manipulation guide is inserted; this increases stiffness and allows the guide wire channel (312) of the operating mechanism shaft (310) of the manipulation guide (300) to be pushed along the stiffened relaxation cannula (237) (where buckling is reduced), and thus provides the subject with a faster and less uncomfortable experience. After external radiotherapy and / or simulated therapy in a specific orientation of the insertion device (204), the manipulator (300) is removed. The reinforcing cannula may be removed after the manipulator (300) has been inserted, or after the manipulator (300) has been removed.

[0167] When the insertion device (204) is used for the cervix (602), the guide suture (218) is long enough to exit through the vagina (606). The trailing end of the guide suture (218) can be secured to the skin using an adhesive pad, for example, in the groin area of ​​the subject between simulation and radiotherapy and / or between radiotherapy fractions.

[0168] The insertion device (204) may include one or more sliding limiting devices (220). The elongated member (210) may be provided with one or more sliding limiting devices (220) configured to reduce or prevent sliding of the elongated member (210) relative to the tube, such as, for example, in… Figure 1 As shown in 2A, 2B, 3, 5 and 23 to 26. The sliding restraint device (220) may engage with the tube wall, for example by friction, or abut against the inlet or outlet of the tube. The sliding restraint device (220) may be attached in a fixed association to the elongated member (210). The sliding restraint device (220) may be disposed at discrete longitudinal locations on the elongated member (210). Examples of sliding restraint devices include an inflatable balloon assembly (230), an expandable support (240), and a stop member (250).

[0169] Two sliding restraints (220) may be present, each disposed at a different longitudinal position on the elongated member (210). One sliding restraint (220) may be disposed at the proximal end (40) of the elongated member (210), and the other may be disposed at the distal end (20) of the elongated member (210). One sliding restraint (220) may be a stop member (250), and the other sliding restraint may be an inflatable balloon assembly (230) or an expandable stent (240). This arrangement allows the two sliding restraints (220) to be laterally attached to the tissue disposed between the inlet and outlet of the tube, thereby effectively clamping the elongated member (210) thereon. The two sliding restraints (220) are disposed at... Figure 3 (See combinations in Tables 1a to e), either end of the elongated member (210) in 24 to 26. Preferably, one of the two sliding restraints (220) is a proximal stop (250). The arrangement of the two sliding restraints (220) can help increase the accuracy of uterine positioning by reducing the degrees of freedom of the elongated member (210) within the uterine canal (604). Furthermore, it addresses the problem observed when the proximal stop (250) is sutured to the cervix; after several fractions, the cervical tumor begins to shrink, and the suture may become looser, allowing movement of the elongated member; this may become important when the operating mechanism shaft (310) is withdrawn after a fraction. By inflating the distally placed balloon assembly (230) or the expandable stent (240), the elongated member (210) becomes fixed within the uterine canal (604) and resists tension, for example, during the withdrawal of the operating mechanism shaft (310).

[0170] The sliding restraint device (220) may be an inflatable balloon assembly (230). The inflatable balloon assembly (230) may include one or more (e.g., two, three, four) inflatable balloons (231, -a to -i) disposed around at least the distal portion (20) of the elongated member (210), as in... Figure 3 (Illustrations in Figures i, ii, iii, vi, vii, viii, xi, xii, xiii, xvi, xvii, xviii, G, H, J), 24, 25, and 26. Two inflatable balloons (231,-a, 231,-b) can be disposed at the distal end of the elongated member (210), optionally arranged radially (e.g., Figure 3 (Figs. i, vi, xi, xvii, G), 24, 25, and 26). An inflatable balloon may be disposed at the distal end of the elongated member (210), optionally having an annular form, such as a conical shape. Figure 3 Figures ii, vii, xii, xvii, 231, -c) or barrel-shaped ( Figure 3 , Figures iii, viii, xiii, xviii, 231, -d; Figure 3 (Figure I231, -h). The walls of the inflatable balloon (231, -a to -i) can be made of any suitable expandable or non-expandable material. Examples of expandable materials include polyurethane, any elastic polymer, film polymers (nylon, compliant polyamide, etc.), or other elastomers. The inflatable balloon (231, -a to -h) can have a limited maximum expansion size, thereby resisting expansion at or above 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.

[0171] The inflatable lumen (234) may be fluidly connected to the inflatable balloon (231, -a to -h). The inflatable lumen (234) may extend in the proximal (40) direction via an inflatable tube (236), such as a catheter or flexible conduit. As previously explained, the inflatable lumen (234) may be formed within a guideline (218); correspondingly, the guideline (218) may be the inflatable tube (236), for example, as... Figure 3 As shown in Figures G, H, and I. The expansion tube (236) can alternatively be disposed outside the elongated member (210), for example, as shown in Figures G, H, and I. Figure 3 As shown in Figures i, ii, iii, vi, vii, viiii, xi, xii, xiii. The expansion tube (236) may extend in the proximal direction outside the elongated member (210).

[0172] After the elongated member (210) has been positioned, the inflatable lumen (234) allows the inflatable balloon lumen (232) to be inflated from outside the body tube. The inflatable balloon (231, -a to -h) can be deflated after treatment by releasing an inflatable fluid (e.g., saline or sterile water) from the inflatable lumen (232) via the inflatable lumen (234). The inflatable fluid may contain a contrast agent. Figures 24 to 26 An example is illustrated of a positioning tool (200) equipped with an inflatable balloon assembly (230), wherein the inflatable balloon (231-e, 231-f, 231-h) is located in the uterine canal (604) and is inflated to prevent or reduce slippage of the elongated member (210). An expansion tube (236) for the controlled inflating and deflating of the balloon (231-e, 231-f, 231-h) is also shown. As previously described, the expansion tube (236) is a guide line (218).

[0173] An inflatable balloon (231-a to -h) can be used to prevent the elongated member from being ejected from the uterine canal during retraction of the manipulator shaft and to improve uterine positioning. In this case, the balloon (231-a to -h) can be inflated once the manipulator shaft (310) of the manipulator guide (300) has been introduced into the elongated member (210). This helps improve the accuracy of uterine positioning by reducing the degrees of freedom of the elongated member (210) within the uterine canal (604). Furthermore, once the cervical tumor begins to shrink, the sutures securing the elongated member (210) to the cervix may loosen, allowing possible displacement of the elongated member. By inflating the balloon, the elongated member will be automatically secured within the uterine canal. The balloon (231-a to -h) can be permanently inflated during the duration of treatment (e.g., 1 to 8 weeks) to prevent the elongated member (210) from dislodging from the uterine canal (604) (even between sessions).

[0174] The sliding limiting device (220) can be an expandable support (240). The expandable support (240) can be disposed at least around the distal portion of the elongated member (210), as in Figure 3 The expandable stent is illustrated in Figures v, x, xv, xx. It can be made of any suitable expandable material such as CoCr alloys, phynox, nitinol, biodegradable metals such as magnesium alloys, zinc alloys, iron, or biodegradable polymers. The expandable stent can be self-expanding or balloon-expandable. The stent can be retracted after treatment by covering it with a sliding sheath that restricts its outer contour. Expandable stents are well known in the art and typically have a tubular form with a mesh-like structure (cut from a tube or made of braided filaments) that expands radially.

[0175] The stop member (250) may be disposed near the proximal end of the elongated member (210), such as in Figure 3 The stop member is illustrated in Figures a, b, d, e, g, h, k, l, n, and o. The stop member acts as a distance limiting device to prevent the elongated member (210) from sliding further into the tube as it abuts the tube inlet. The stop member is located at the proximal end of the elongated member (210). The stop member protrudes from the outer surface of the elongated member (210). The stop member (250) is provided in a fixed (non-moving) association with the elongated member (210). The stop member (250) can be rigid. The stop member can include an annular structure. It can be formed of the same material as the member (210), or it can be formed of a different material. The stop member (250) may be provided with one or more suture passages (252). The suture passages allow the stop member to be sutured to the tube inlet, for example, to the dam of the cervix. Figure 5 and 23Examples 25 and 26 illustrate an insertion device (204) with a stop member (250) provided at the proximal end of the elongated member (210). The positioning tool (200) is located in the cervix (602) or in the cervix (602) and uterine canal (604), and the stop member abuts against the dam of the cervix (602) to prevent or reduce the sliding of the elongated member (210).

[0176] The sliding limiting device (220) may be a region at the distal portion of the elongated member (210) including one or more distal protrusions. The protrusions may be lateral protrusions (245), such as... Figure 3 The projection is illustrated in Figures iv, ix, xiv, and xix. The projection can be annular or segmental. The distal projection (245) acts as a restraining device to prevent or reduce further slippage of the elongated member (210) into the tube as it abuts against the tube 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 (non-moving) association with the elongated member (210). The distal projection (245) can be rigid. The distal projection (245) can include annular structures. It can be formed of the same material as the member (210) or it can be formed of a different material.

[0177] The elongated member (210) may have one or more discharge passages (270, -a, -b, -c) at its distal end (20), for example, Figure 3 As shown in Figures B, C, D, E, F, K, N, O, P. A discharge passage fluidly connects the inner cavity (214) of the elongated member to the outer surface of the elongated member (210). Discharge passages (270, -a, -b) may be positioned toward the distal end of the elongated member (210). The distal end of the elongated member (210) may be open to the inner cavity (214), thereby forming the discharge passage (270, -b). A guide line (218) may be attached to a support (213) that is attached to the inner cavity (214) of the elongated member without obstructing the fluid passage (e.g., ...). Figure 3(Figures C and O). A drainage passage (270, -c) may be provided on the sidewall of the lumen (214) of the elongated member. One or more drainage passages (270) allow drainage of fluid that may have been generated within the uterine canal and is to be safely removed. When the operating mechanism shaft is not within the elongated member, fluid exits from the proximal end of the lumen (214), for example, into the vaginal canal (606) before or after simulation and / or radiotherapy. The drainage passage allows fluid to drain from the tube, thus significantly reducing the risk of infection. The drainage passage may also serve as an outlet port for a guide wire (218), and vice versa. The drainage passage may also serve as a threaded channel (272, -c) for a removable guide wire (218), and vice versa.

[0178] The insertion device can be provided with any of a variety of different arrangements of discharge passages (270), side restraints (220), outlet ports (272), threaded channels (272, -c), and guide lines (218). For example, a distal sliding restraint, a proximal sliding restraint, an outlet port, and one or more discharge passages may or may not be provided. In the case of both discharge passages and distal sliding restraints (i to v), the discharge passage may be located on the side of one of the two ends of the distal sliding restraint.

[0179] exist Figure 3 In the process, any one of the elongated members (A, B, C, D) may be combined with the proximal sliding limiting device (a, b) or may not be combined with the proximal sliding limiting device (c); the elongated members (A, B, C, D) may or may not include the distal sliding limiting device (i, ii, iii, iv, v).

[0180] In addition, Figure 3 In the process, any one of the elongated members (E, F) may be combined with the proximal sliding restraint device (d, e) or may not be combined with the proximal sliding restraint device (f); the elongated members (E, F) may or may not include the distal sliding restraint device (vi, vii, viiii, xiv, x); the guide line is detachable.

[0181] In addition, Figure 3 In the process, any one of the elongated members having distal sliding limiting devices (G, H, J) may be combined with a proximal sliding limiting device (g, h) or may not be combined with a proximal sliding limiting device (j); the guide line is an expansion tube.

[0182] In addition, Figure 3In the process, any one of the elongated members (K, L) may be combined with the proximal sliding restraint device (k, 1) or may not be combined with the proximal sliding restraint device (m); the elongated members (K, L) may or may not include the distal sliding restraint device (xi, xii, xiii, xiv, xv); the guide line is detachable.

[0183] In addition, Figure 3 In this configuration, any one of the elongated members (M, N, O, P) may be combined with a proximal sliding restraint device (n, o) or may not be combined with a proximal sliding restraint device (p); the elongated members (M, N, O, P) may or may not include a distal sliding restraint device (xvi, xvii, xviii, xiv, xv); the guide line is a relaxation tube. In the presence of both the distal sliding restraint device (i to xx) and the discharge channel or outlet port, the distal sliding restraint device (i to xx) may be located within a region (e.g., 211) of the elongated member (210) that does not obstruct the discharge channel.

[0184] In the presence of both the remote sliding limit device (i to xx) and the discharge passage or outlet port, the remote sliding limit device (i to xx) can be disposed within an area (e.g., 211) of the elongated member (210) that does not obstruct the discharge passage.

[0185] Examples of different combinations are provided in Tables 1a to 1e below. The exemplary elements mentioned in Tables 1a to 1e... Figure 3 Described in the text.

[0186]

[0187]

[0188] Table 1a shows an exemplary combination of features of the insertion device (204) when the guide line (218) is a flexible cord (219). Explanation: A - elongated member without a discharge passage; B - elongated member with a discharge passage at the distal end; C - elongated member open at the distal end; D - elongated member with a discharge passage at the distal end on the sidewall; a - proximal stop member with a suture passage (sliding restriction device); b - proximal stop member without a suture passage (sliding restriction device); c - no proximal stop member (sliding restriction device); i - a pair of distal balloons (sliding restriction device); ii - distal conical balloon (sliding restriction device); iii - distal barrel balloon (sliding restriction device); iv - distal protrusion (sliding restriction device); v - expandable support (sliding restriction device); GS guide line. Figure 3 Exemplary implementations of each feature (A, B, C, D, a, b, c, i, ii, iii, iv, v) are shown.

[0189]

[0190] Table 1b shows exemplary combinations of insertion device features when the guide wire is detachable. Explanation: E - an elongated member with an outlet port as a channel; F - an elongated member with an outlet port open at the distal end; d - a proximal stop member (sliding restrictor) with a suture passage and a reciprocating stop; e - a proximal stop member (sliding restrictor) without a suture passage but with a reciprocating stop; f - an elongated member without a proximal stop member (sliding restrictor) and with a reciprocating stop; vi - a pair of distal balloons (sliding restrictor); vii - a distal conical balloon (sliding restrictor); viiii - a distal barrel balloon (sliding restrictor); ix - a distal protrusion (sliding restrictor); x - an expandable stent (sliding restrictor); GS - guide wire. Figure 3 Exemplary implementations of each feature (E, F, d, e, f, vi, vii, viiii, ix, x) are shown.

[0191]

[0192]

[0193] Table 1c shows an exemplary combination of features of the insertion device (204) when the guide wire (218) is an expansion tube (236). Explanation: G - an elongated member having a pair of distal balloons (sliding restrictors); H - an elongated member having a distal conical balloon (sliding restrictor); J - an elongated member having a distal barrel balloon (sliding restrictor); g - a proximal stop (sliding restrictor) with a suture passage; h - a proximal stop (sliding restrictor) without a suture passage; j - no proximal stop (sliding restrictor). Figure 3 Exemplary implementations of each feature (G, H, J, g, h, j) are shown.

[0194]

[0195] Table 1d shows an exemplary combination of insertion device features when the guide wire is detachable. Explanation: K - an elongated member with a threaded channel (272, -c); L - a guide wire attached to the elongated member using a detachable connection; k - a proximal stop member (sliding restrictor) with a suture passage; 1 - a proximal stop member (sliding restrictor) without a suture passage; m - no proximal stop member (sliding restrictor); xi - a pair of distal balloons (sliding restrictor); xii - a distal conical balloon (sliding restrictor); xiii - a distal barrel balloon (sliding restrictor); xiv - a distal protrusion (sliding restrictor); xv - an expandable support (sliding restrictor); GS - guide wire. Figure 3 Exemplary implementations of each feature (K, L, k, l, m, xi, xii, xiii, xiv, xv) are shown.

[0196]

[0197] Table 1e shows an exemplary combination of features of the insertion device (204) when the guide wire (218) is a relaxation tube (237). Explanation: M - elongated member, no discharge passage; N - elongated member with discharge passage at the distal end; O - elongated member open at the distal end; P - elongated member with discharge passage at the distal end on the sidewall; n - proximal stop member with suture passage (sliding restrictor); o - proximal stop member without suture passage (sliding restrictor); p - no proximal stop member (sliding restrictor); xvi - a pair of distal balloons (sliding restrictor); xvii - distal conical balloon (sliding restrictor); xviii - distal barrel balloon (sliding restrictor); xviv - distal protrusion (sliding restrictor); xx - expandable stent (sliding restrictor). Figure 3 Exemplary implementations of each feature (M, N, O, P, n, o, p, xvi, xvii, xviii, xix, xx) are shown.

[0198] The positioning tool (200) may also include a removable manipulation guide (300), such as, for example, in Figures 5 to 21 As shown in Figure 26, this is for manipulating the position and / or orientation of the insertion device (204). The manipulation guide (300) has a proximal end (40) and a distal end (20). The manipulation guide (300) may be detachably attached to the insertion device (204) or the elongated member (210). The manipulation guide (300) may be provided with a guide wire channel (312) for its slidable movement along a guide wire (218). The guide wire channel (312) may be provided at least partially along the length of the manipulation guide (300), for example, along an operating mechanism shaft (310) and / or a transmission device (314) as described later below.

[0199] An operating mechanism shaft (310) located at the distal end (20) of the operating guide is configured to be inserted into the elongated member cavity (214) along a guide line (218). The operating mechanism shaft (310) is configured to be (repeatably) slidably and removably inserted into the elongated member cavity (214). The operating mechanism shaft (310) may have a circular cross-sectional outer profile perpendicular to its longitudinal axis. The outer profile may have the same dimensions in the axial direction. The outer profile may taper gradually in the axial direction; the smaller profile may be at the distal end.

[0200] The operating mechanism shaft (310) may have one or more recesses on its surface that engage with complementary protrusions in the inner surface of the elongated member cavity (214). This arrangement allows the operating mechanism shaft (310) to latch within the elongated member cavity (214). The operating mechanism shaft (310) can be engaged in a position within the insertion device (204). Removal of the operating mechanism shaft (310) is performed by pulling against the latching force.

[0201] The operating mechanism shaft (310) is preferably rigid. It is preferably non-flexible. It can be formed essentially of a rigid rod. It can be in a straight form for use, for example, with the cervix, uterus, anus, or vagina. It can be in a straight form for use, for example, with the cervix and / or uterus. It can be in a curved form.

[0202] The operating mechanism shaft (310) can be made of biocompatible, radio-visible materials such as titanium or coated aluminum. It is preferably made of a low-density material to avoid artifacts under CT or PET / CT. The operating mechanism shaft (310) can be made of MRI-compatible materials such as titanium or coated aluminum. It can also be made of biocompatible, high-density materials such as tantalum. However, tantalum will cause more artifacts under CT and PET / CT. To reduce artifacts under CT and PET / CT, a radio-invisible insertion device (204) can be combined with a radio-visible operating mechanism shaft (made of low-density metals such as titanium or coated aluminum).

[0203] The operating mechanism shaft (310) may be provided with a guide wire channel (312) for its slidable movement along the guide wire (218). The guide wire channel (312) may be an inner cavity within the operating mechanism shaft (310) or a longitudinal groove on the surface of the operating mechanism shaft (310) (e.g., Figure 10 and details Figure 10A The guide wire channel (312) may be provided at least partially along the longitudinal length of the operating mechanism shaft (310). The inlet (312, -a) of the guide wire channel is located at the distal end of the operating mechanism shaft (310), preferably at the distal tip. The outlet (312, -b1 to -b5) from the guide wire channel is located at the proximal end (i.e., on its proximal side) of the inlet (312, -a). Figure 6Different possible locations of the inlet (312, -a) and outlet (312, -b) of the guide wire channel (312) are shown, where the guide wire channel is an inner cavity. The outlet (312, -b1) of the guide wire channel (312) can be located at the distal end of the operating mechanism shaft (310). The outlet (312, -b2) of the guide wire channel (312) can be located at the proximal end of the operating mechanism shaft (310). The outlet (312, -b3) of the guide wire channel (312) can be located at the distal end of the transmission device (314). The outlet (312, -b4) of the guide wire channel (312) can be located in the middle of the transmission device (314). The outlet (312, -b5) of the guide wire channel (312) can be located at the proximal end of the transmission device (314).

[0204] exist Figure 7 In this configuration, the inlet (312, -a) of the guide wire channel (312) is located at the distal tip of the operating mechanism shaft (310), and the outlet (312, -b3) is positioned towards the distal end of the transmission device (314). Figure 8 In the middle, the outlet (312, _b5) is located at the junction of the proximal end of the transmission device (314) and the distal end of the handle (316). Figure 9 In this configuration, the inlet (312, -a) of the guide line channel (312) is located at the distal tip of the operating mechanism shaft (310), and the outlet (312, -b2) is positioned towards the proximal end of the operating mechanism shaft (310). The greater the distance between the outlet (b) and the inlet (a), the longer the guide line (218). Figure 15 , 17 In 18, the inlet (312, -a) of the guide line channel (312) is located at the distal tip of the operating mechanism shaft (310), and the outlet (312, -b4) is located toward the middle of the transmission device (314).

[0205] The operating mechanism shaft (310) can be made of any suitable biocompatible material such as medical grade nonferromagnetic stainless steel, tantalum, titanium, polycarbonate, PEEK, carbon fiber, glass fiber, fiber-reinforced polyaramid resin (e.g., Ixef (Solvay)), or coated aluminum.

[0206] Typically, a simulated treatment is first performed under CT or PET CT scans or MRI. Subsequently, the treatment may involve acquiring one or more X-ray images in the treatment room. Preferably, the operating mechanism shaft (310) is made of a material compatible with medical imaging such as CT, MRI, or X-rays. The material may be visible or invisible on the medical images.

[0207] When the operating mechanism shaft (310) is visible on a medical image, the orientation of the operating mechanism shaft (310) can be determined directly from the medical image of the operating mechanism shaft (310). When the treatment is simulated under MRI, the operating mechanism shaft (310) can be made of low-density materials such as PEEK or polycarbonate, fiber-reinforced polyaramid resin (e.g., Ixef (Solvay)), or MR-compatible (non-magnetic) materials such as aluminum coated with a layer of biocompatible metal (titanium), or titanium. For CT scan simulation, coated aluminum or titanium, PEEK, polycarbonate, or fiber-reinforced polyaramid resin (e.g., Ixef (Solvay)) (mixed with barium sulfate) will also be an advantage because it allows for fewer artifacts compared to using high-density metals such as stainless steel. One aspect is that coated aluminum, PEEK, polycarbonate, or fiber-reinforced polyarylamide resin (e.g., Ixef (Solvay)) manipulator guides (300) (mixed with barium sulfate) are used for simulation and stainless steel is used for treatment. Another aspect is that aluminum manipulator guides (300) or PEEK, polycarbonate, or fiber-reinforced polyarylamide resin (e.g., Ixef (Solvay)) (mixed with or without barium sulfate) are used for simulation and for treatment. Most modern imaging devices combined with radiotherapy allow good visibility of any metallic structure or radio-visible polymer such as the manipulator shaft (310). In this case, the manipulator shaft may be visible on its own and may not necessarily require the presence of imaging markers visible to the imaging device.

[0208] Where the operating mechanism shaft (310) is not visible or is visible but insufficient to determine the position and / or orientation of the insertion device, the operating mechanism shaft (310) may be provided with one or more imaging markers (350, a, b). This is helpful when performing imaging using imaging tools with a linear accelerator. The manipulation guide device (300), particularly the operating mechanism shaft (310), may be provided with one or more imaging markers that can be identified by medical images. The imaging markers may be fixedly associated with the operating mechanism shaft (310), for example, on the inner surface, outer surface, or within the operating mechanism shaft (310). The imaging markers may be made of a material different from that of the operating mechanism shaft (310) (e.g., heavy metals, such as platinum, platinum-iridium, tantalum, tungsten, etc.).

[0209] The operating mechanism shaft (310) can have a length (E) of 1-10 cm, preferably 4-10 cm (E) for cervical / uterine insertion. The maximum outer diameter can be 0.3-0.7 cm. The diameter of the operating mechanism shaft (310) can be uniform from proximal to distal or can vary. For example, the diameter can be larger towards the proximal portion and smaller towards the distal portion. The change in diameter can be gradual. The change in diameter can be gradual along the length of the operating mechanism shaft (310). The operating mechanism shaft can adopt an angle α relative to the transmission device (see...). Figure 6 Angle α is measured in the plane formed between the transmission and the operating mechanism. When the handle and the operating mechanism shaft are on the same side of the transmission (forward), angle α is less than 180 degrees; when the handle and the operating mechanism shaft are on opposite sides of the transmission (reverse), angle α is greater than 180 degrees. When the handle and the operating mechanism shaft are coaxial or in a straight line, angle α is 180 degrees. For preferred dimensions and angles for various medical applications, see Tables 2 and 2a.

[0210] A handle portion (316) located at the proximal end (40) of the guide device (300) is provided in a fixed association (position and orientation) with the operating mechanism shaft (310). Accordingly, directional and / or positional movement of the handle portion (316) causes corresponding directional and / or positional movement of the operating mechanism shaft (310). The handle portion (316) is preferably rigid. It is preferably non-flexible. It may be formed substantially of a rigid rod.

[0211] The handle (316) can have a length (H) of 2-50 cm, preferably 15-25 cm for cervical / uterine applications. In very obese subjects, the handle (316) can have a length of up to 40 or 50 cm. The diameter can be 0.3-3 cm, preferably 0.5-2 cm.

[0212] The handle can be positioned at an angle β relative to the transmission mechanism (e.g., Figure 6 Angle β is measured on the plane formed between the transmission and the handle. When the handle and the operating mechanism shaft are on the same side of the transmission (forward), angle β is less than 180 degrees; when the handle and the operating mechanism shaft are on opposite sides of the transmission (reverse), angle β is greater than 180 degrees. For preferred dimensions and angles for various medical applications, see Tables 2 and 2a.

[0213] The handle (316) can be made of any suitable biocompatible material such as medical-grade nonferromagnetic stainless steel, tantalum, titanium, polycarbonate, PEEK, carbon fiber, glass fiber, fiber-reinforced polyaramid resin (e.g., Ixef (Solvay)), polyphenylene sulfone (PPSU), aluminum (coated), bioceramics such as aluminosilicate, styrene-acrylonitrile, or bioceramic-polymer materials. The handle (316) can be made of the same material as the transmission device (314). The handle (316) can have the same diameter as the proximal end (40) of the transmission device (314).

[0214] The handle (316) can be formed from an imaging transparent material such as a polymer rod or tube. For ease of manufacture, the same material can be used to form the transmission device (314); this reduces imaging artifacts caused by the transmission device (314) in the vaginal region (606)—described in more detail below. Examples of suitable polymers include polycarbonate. Other materials that can be used for the handle are glass fiber, carbon fiber, fiber-reinforced polyaramid resins (e.g., Ixef (Solvay)), polyphenylsulfone (PPSU), bioceramics such as aluminosilicates, styrene-acrylonitrile, bioceramic-polymer materials, etc. Figure 7 , 8 Examples of manipulation guides (300) are depicted, which are formed by a polymer handle portion (316) and a transmission device (314) and have a larger diameter (e.g., 0.8-2.5 cm) than an operating mechanism shaft (310) that may be formed by a rigid metal such as titanium or a hard polymer (polycarbonate, PEEK, fiber-reinforced polyaramid resin).

[0215] The manipulation guide (300), particularly the handle (316) and / or the transmission (314), may be provided with one or more (e.g., two, three or more) radio frequency identification (RFID) tags. The RFID tags allow identification of the manipulation guide (300). The system may be provided with an RFID tag reading unit, which includes an RFID tag reader and a processor or interface to the processor, configured to prevent operation of the robotic arm when the RFID tag does not match the expected RFID tag stored in the system. Since radiation oncology departments may have multiple manipulation guides of different sizes (see, for example, Table 2 herein) for different subjects, providing RFID tags prevents the provision of incorrect manipulation guides (300) to subjects. The RFID tags may be disposed within the body of the manipulation guide (300). In particular, they may be disposed within a slot provided in a reinforcing strut (317) (see, for example...). Figure 15 , 16(17, 19 to 21). For example, it can be placed in a slot provided on the side of the handle (316). The RFID tag can be rewritable or non-rewritable. A non-rewritable RFID chip allows the manipulation guide to be attributed to only a single patient, which reduces workflow errors. The system will not allow the manipulation guide RFID chip to be rewritten and used for other patients.

[0216] The handle (316) can be configured to attach to a positioning device; this attachment is preferably non-removable. The positioning device is configured to adjust and fix the position and / or orientation of the handle (316) and thus adjust and fix the position and / or orientation of the operating mechanism shaft (310). The positioning device typically has end effector fittings (e.g., a set of claws, chucks) for non-removable attachment to the handle. It has a base, for example, fixed to a floor, ceiling, or simulation or treatment table. Preferably, the base of the positioning device is fixed to or can be fixed to a simulation or treatment table between the subject's legs. The end effector has multiple degrees of freedom of movement (e.g., 3, 4, 5, 6, 7, 8) and position and / or orientation of the end effector. The positioning device may include multiple links connected in a kinetic chain via rotary joints (also called shafts). It has multiple shafts (e.g., 3, 4, 5, 6, 7, 8) to allow the end effector to take on many controllable positions and orientations.

[0217] The connector of the positioning device can be passive (non-motorized). In a passive system, the connector can be manually adjustable, releasable, and lockable. Once the attitude (position and / or orientation) of the end effector is manually set, the connector is locked and the attitude of the end effector accessory is fixed.

[0218] The connector of the positioning device can be motorized. The positioning device can be a robotic arm (RA). In the robotic arm, the position of the connector, and therefore the attitude (position and / or orientation) of the end effector accessory, is controllable by electronic signals. The robotic arm can have a "zero-gravity mode," in which the weight of the arm is supported by the motorized connector, but the attitude (position and / or orientation) of the end effector can be manually set and then locked. Therefore, the robotic arm can be operated manually or electronically.

[0219] The RA can have a switchable zero-gravity mode. In zero-gravity on (weightless) mode, the robotic arm joint can be supported or unsupported (e.g., by a servo system) to prevent the arm from collapsing. The posture of the RA accessory can be manually guided, for example, by a medical professional. This allows for easy connection between the positioning tool (200) and the RA accessory once the positioning tool (200) has been inserted into the subject. This also allows for manual fine-tuning of the posture of the guiding device (300) for simulation and treatment. Once a connection has been established between the RA accessory and the handle (316), the zero-gravity mode can be deactivated and actions can be performed as described elsewhere herein. The RA operating in zero-gravity on mode can continuously record the posture of the RA accessory so that when the zero-gravity mode is deactivated (zero-gravity off mode), the RA can continue to be controlled by the controller processing unit (440) and the manipulator (300) for a therapeutic or simulation posture without intermediate calibration operations. Therefore, after entering the zero-gravity off mode, the RA accessory's posture is initially determined based on the last recorded posture of the RA accessory when exiting the zero-gravity on mode.

[0220] Robotic arms are known in the field, for example those manufactured by Universal Robots (Denmark) or Kuka (Germany).

[0221] Positioning devices (such as robotic arms) are typically positioned such that the end effector accessory is positioned between the patient's legs.

[0222] To facilitate attachment to a positioning device, the handle (316) may be provided with a gripping positioning device (300) comprising one or more notches (334) and / or one or more protrusions and / or one or more corners (332), which mate with an end effector accessory, wherein the end effector accessory includes a gripping device, such as a set of claws or a chuck. The gripping positioning device (300) becomes securely located within the closed gripping device, thereby limiting and preventing rotation and / or movement between the gripping device and the handle (316). An exemplary gripping positioning device in Figures 11 to 16 As shown in Figures 19 to 21. A grip positioning device (300) may be disposed at the proximal end of the handle portion (316). The base of the notch (334) may be pointed, flat, or linear (e.g., elongated). The notch (334) may have straight edges (e.g., radial edges) or beveled edges. The grip positioning device (330) allows for a very accurate and reproducible mountable-detachable attachment of the end effector accessory to the handle portion (316). The grip positioning device allows the gripping device providing the handle portion (316) to grip with high position repeatability and reduced backlash or recoil. The end effector accessory coupled to the gripping position (300) is attached to the gripping position (300) in a fixed association with the gripping position (300).

[0223] The gripper claw may be provided with one or more protrusions that engage with gripping positioning devices (e.g., one or more notches) on the handle portion (316) when the gripper is closed. When the notch has a bevel, the angled protrusions on the gripper align the operating guide (300) when closed.

[0224] An example of the notch (334) of the gripping positioning device (330) is shown in Figures 11 to 13 Given in 15A to 15C, 16, 19 to 21. Figure 11 In the middle, the straight-edged notches (334) (each with a flat base) are longitudinally separated and set at different radial positions, in Figure 12 In the middle, a set of proximal straight-edge notches, each with a flat base (having the same longitudinal position but different radial positions), and a set of distal notches (having a slightly different longitudinal position but the same different radial position) are provided, and in... Figure 13 In the middle, the notch is similar to Figure 12 They are arranged, but they have beveled (V-shaped) sides and linear bases. Figure 15B In C and 16, a beveled (V-shaped) notch (334) with a linear base is provided.

[0225] One or more corners (332) of the grip positioning device (330) may be provided along the axial direction of the proximal end of the handle portion (316). The corners (332) may be square. There may be only one corner. The grip positioning device (330), as a combination of a notch (334) and a corner (332), allows for stable gripping by the end effector accessory when it is a gripping device with a pair of claws. At least one notch and corner may have different relative orientations, preferably perpendicular. At least one notch may be provided within the longitudinal span of the corner. For example, the corner may extend along the axial direction at the proximal end of the handle portion (316), while the base of the notch may extend perpendicular to the axial direction; this ensures absolutely reproducible fixation of the manipulation guide relative to the end effector accessory and eliminates additional uncertainty of the manipulation guide relative to the base end of the positioning device.

[0226] Figure 15A In B and C, 16, a grip positioning device (330) is provided at the proximal end of the handle portion (316), which includes a single corner (332) along the axial direction of the proximal end of the handle portion (316), and a beveled (V-shaped) notch (334) with a linear base is provided within the longitudinal span of the corner. Figure 15A An end view of the handle portion (316) depicting the corner (332) is shown.

[0227] The gripper jaws can close to form a profile similar in outline to the cross-section of the gripping positioning device (330); this profile can in particular complement the corners (332) of the gripping positioning device (330). When the gripper jaws are closed, the corners (332) located in the profile of the gripper jaws ensure that the manipulation guide (300) is correctly and stably aligned with the positioning device.

[0228] The handle (316) may be provided with a docking beacon (340) configured to provide information about the position and optional orientation of the manipulation guide (300) relative to the end effector accessory. The docking beacon (340) allows manual, semi-automatic, or automatic guidance of the end effector accessory, including gripping devices (e.g., a set of claws, a chuck), to the handle (316), particularly to the handle positioning device (330). The position and optional orientation of the manipulation guide (300) relative to the end effector accessory can be determined and tracked in real time.

[0229] Example docking beacon (340) in Figures 19 to 21 As shown in the diagram. Based on the relative attitude of the docking beacon (340) and the end effector accessory, the attitude of the end effector accessory can be adjusted in real time as it approaches the handle (316), thereby allowing coupling without interfering with the attitude of the manipulation guide device (300) already inserted in the subject tube. A closed feedback loop can be used to guide the end effector accessory toward the target docking beacon (340); if the approaching end effector accessory deviates from the target handle (316), a correction to the approach direction is applied until the approach is on the target. The closed feedback loop continuously checks and corrects the approach direction. The docking beacon (340) can be located at the proximal tip of the handle (316). The docking beacon can be located on the handle (316) near the handle positioning device (330). The docking beacon (340) can be passive, active, or a combination of passive and active. The docking beacon (340) can be detachable from the handle (316). The docking beacon (340) is non-removable from the handle (316).

[0230] The passive docking beacon comprises a body of a predefined geometry recognizable by a vision-guided robotic system (e.g., one or more cameras, laser scanners). Vision-guided robotic systems are well known in the art. The shape and orientation of the body allow for the recognition of the attitude of the handle portion (316). The body of the passive docking beacon can be positioned at the proximal end of the handle portion (316), preferably at the proximal tip. It can be positioned at the proximal end of a gripping positioning device (330). An optical recognition system can be configured to attach to an end effector accessory.

[0231] The main body of a passive docking beacon may include multiple spheres (361i to iv), such as... Figure 19 As shown in the diagram. The number of spheres can be at least three. The positions and spacing of the spheres are predefined. The orientation of the handle (316) can be determined based on a two-dimensional image of the spheres and their mutual distances. The distance between the end effector fitting and the handle can be determined based on a two-dimensional image of the spheres and their diameters, and will appear the same in any orientation.

[0232] The main body of a passive docking beacon can include a two-dimensional shape (344) (e.g., a rectangle), such as... Figure 20 As shown. The rectangular form has predefined dimensions and shape. The orientation of the handle (316) can be determined from a two-dimensional image of the rectangular form, which presents a steering structure according to the orientation. The distance of the end-operating mechanism accessory from the handle can be determined from a non-contact distance measuring device (e.g., a laser or ultrasonic rangefinder); in the case where the optical recognition system is a laser scanner, it can be combined with a laser rangefinder.

[0233] The active docking beacon wirelessly transmits information that allows determination of the position and / or orientation of the handle (316). It may include a solid-state gyroscope (3-axis). It may include a solid-state gyroscope (3-axis), a wireless transmitter (e.g., Bluetooth), a controller, and a replaceable or rechargeable power source. The approach angle of the end effector accessory can be adjusted based on the attitude of the handle (316), as transmitted by the active docking beacon. The distance between the end effector accessory and the handle (316) can be determined using a non-contact distance measurement device (e.g., a laser or ultrasonic rangefinder). An exemplary active docking beacon (342) is, for example, in… Figure 21 As shown in the image.

[0234] Another example of an active docking beacon is an array of location-determining radio transponders, as described elsewhere in this document. The transponder's position can be tracked in real time by a space transponder detector, which typically provides sub-millimeter, sub-degree accuracy. The transponder can receive power inductively or from a built-in power source (e.g., via a battery located on the handle of the control device).

[0235] The handle (316) can be manually guided to or can be connected to an end effector accessory. In the case of a robotic arm (RA) as the positioning device, manual docking can be performed in RA zero-gravity mode. The RA can have a switchable zero-gravity mode. In zero-gravity-on (weightless) mode, the robotic arm's joint can be supported or unsupported (e.g., via a servo system) to prevent the arm from collapsing. The posture of the RA accessory can be manually guided, for example, by a medical professional. This allows for easy connection between the positioning tool (200) and the RA accessory once the positioning tool (200) has been inserted into the subject. This also allows for manual fine-tuning of the orientation of the guide device (300) for simulation and treatment. Once a connection has been established between the RA accessory and the handle (316), the zero-gravity mode can be deactivated and actions can be performed as described elsewhere herein. The RA operating in zero-gravity on mode can continuously record the posture of the RA accessory, so that when the zero-gravity mode is deactivated (zero-gravity off mode), the RA can continue to be controlled by the controller processing unit (440) and the manipulation guide (300) to a therapeutic or simulated posture without intermediate calibration operations. Therefore, after entering zero-gravity off mode, the posture of the RA accessory is initially determined based on the last recorded posture of the RA accessory when exiting zero-gravity on mode.

[0236] When the positioning device is a robotic arm (RA), docking can be achieved by setting the RA accessory on the radiotherapy table to one of the treatment postures and attaching the RA accessory to the handle (316) of the manipulation guide (300) inside the patient. The manipulation guide (300) is introduced into the patient and placed in the same position as during the simulation using laser light and imaging. Then, the posture of the robotic arm is adjusted to the same posture (treatment posture) achieved during the simulation. The treatment posture is maintained while the manipulation guide is manually connected to the operating mechanism end (gripper) of the robotic arm. Therefore, the manipulation guide will have the same posture inside the patient as during the simulation.

[0237] The operating mechanism shaft (310) and handle (316) can be connected via a transmission device (314). The transmission device (314) is typically a rigid rod. The transmission device can be fixedly connected and positioned (i.e., oriented and / or positioned) to both the operating mechanism shaft (310) and handle (316). It can be straight, curved, or contain one or more angled bends. It can be substantially formed of a rigid rod. The rod can be hollow or solid.

[0238] The transmission device (314) may have a length (T) of 1-30 cm, preferably 8-20 cm (e.g.) Figure 6This depends on the type of tumor. The transmission device (314) can have a diameter of 0.3-3 cm, preferably 0.3-1.5 cm. The handle and the plane formed between the transmission device and the operating mechanism shaft can adopt an angle γ relative to each other (see, for example, see...). Figure 6A For preferred dimensions and angles for various medical applications, see Tables 2 and 2a.

[0239] The diameter can be consistent from proximal to distal or it can vary. For example, the diameter can be larger towards the proximal portion of the actuator and smaller towards the distal portion. The change in diameter can be gradual. When entering the vagina, the smaller distal diameter is more non-invasive, while the larger diameter towards the proximal portion improves the rigidity of the manipulator (300).

[0240] The handle (316) can be connected to the transmission (314). The transmission (314) may have the same diameter (e.g., 0.3-3 cm, preferably 0.5-2 cm) for a portion of its proximal length as the handle (316), for example, 2.5-3 cm of the proximal length of the transmission (314). Allowing the larger diameter of the handle (316) to extend into the proximal portion of the transmission (314) allows for stiffening of the operating guide (300). A support (317) may be provided at the corner between the handle (316) and the transmission (314) (e.g., ...). Figure 15 , 16 17).

[0241] The distal portion (20) of the transmission device (314) may have a small diameter (0.3-1 cm) so that it is non-invasive (non-invasive when entering the vagina).

[0242] The guide wire channel (312) can continue from the operating mechanism shaft (310) into the transmission device (314). The guide wire channel (312, ab) can be an inner cavity within the transmission device (314) or a longitudinal groove on the surface of the transmission device (314). The guide wire channel (312) can extend at least partially along the longitudinal length of the transmission device (314). Figure 6 In the transmission device, the possible guide wire channel (312) outlet is at the distal end (312, -b3), the middle section (312, -b4), or the proximal end (312, -b5). Figure 7 In the transmission device, the guide wire channel (312) outlet is at the far end (312, -b3). Figure 8 In the transmission device, the guide wire channel (312) outlet is at the proximal end (312, _b5). Figure 15 , 17In 18, the possible guide line channel (312) outlet on the transmission device is at the middle section (312, _b4).

[0243] The inflatable transmission balloon (322) can be positioned toward the distal end (20) of the transmission device (314), for example, as Figure 6 , 9 As shown in 16, 17, 18, and 26. The inflatable transmission balloon (322) can be used to dilate the vagina, preferably to a known or fixed diameter, for use in radiotherapy. It can further center the transmission device (314), for example, within the vaginal canal (606). In its inflated state, it helps to position the vaginal canal (606) in a defined location and / or orientation and / or diameter for radiotherapy. The diameter of the transmission device (314) can be smaller at the distal end (20), allowing the inflatable transmission balloon (322) to enter the vaginal canal (606) together with the transmission device (314), which is less painful. The expansion of the inflatable transmission balloon (322) dilates the vaginal wall, thereby positioning the wall. The wall of the inflatable transmission balloon (322) can be made of any suitable expandable or non-expandable material. Examples of expandable materials include latex, any elastic polymer, film polymer (polyurethane, etc.), or other elastomers. The inflatable actuator balloon (322) can have a limited inflation size (maximum), thereby resisting inflation to or beyond the maximum inflation size (semi-compliant or non-compliant balloon). In other words, the inflatable actuator balloon (322) can be expansion-limited, wherein expansion reproducibly stops at the limited inflation size. Continuous inflation by applying hydraulic pressure at or above the limited inflation size will not result in further expansion. The limited inflation size is reproducible, for example, in one or more further treatments. The reproducible limited inflation size ensures that the target is in the correct position for a given treatment posture, as expansion stops once the limited size has been reached. The distance between the inflatable balloon wall and the actuation mechanism axis is known and / or reproducible. In particular for repeated treatments in fractionated treatment procedures, the limited inflation size reduces placement errors in subsequent treatments. The limited maximum inflation size can be achieved by forming the balloon wall from a non-expandable material such as PET, non-compliant, or semi-compliant polyamide. The inflatable actuator balloon (322) can have a maximum inflation diameter of 2.0 to 5 cm. Examples of the size of the transmission balloon (322) and its medical applications are provided in Tables 2 and 2a.

[0244] Fluidly connected to the inflatable transmission balloon (322) may be an inflatable lumen extending in the proximal (40) direction via an inflatable tube such as a catheter or flexible conduit. This structure may be within or parallel to the transmission section (314). The inflatable transmission balloon (322) may be deflated after simulation and / or after each course or fraction of radiotherapy by releasing an inflatable fluid (e.g., saline), thereby allowing the guide device (300) to be withdrawn.

[0245] Fluidly connected to the inflatable transmission balloon (322) may be an inflatable cavity (328) extending in the direction of the proximal end (40) of the manipulation guide (300) (e.g. Figure 17 , 18 The inflatable cavity (328) may be located within at least a portion of the main body of the transmission unit (314). The inflatable cavity (328) may be external and parallel to at least a portion of the transmission unit (314). A fitting (329) (e.g., a Luer fitting) may be disposed proximal to the inflatable cavity (328) for connection to a pump. The inflatable transmission balloon (322) may be reduced in size after simulation and / or after each cycle or fraction of radiotherapy by releasing an inflatable fluid (e.g., saline or sterile water), thereby allowing the manipulation guide device (300) to be withdrawn.

[0246] The transmission balloon (322) can be inflated with saline or sterile water. It may optionally contain 0.5-4% contrast agent, which allows the transmission balloon to be visible on CT simulation images and / or on images prepared prior to a radiotherapy session or fractionation. Alternatively, the transmission balloon (322) may be provided with one or more imaging markers (e.g., imaging visible filaments (longitudinal, spiral, circular)). One or more radio location-determining transponders may be located on the inflatable transmission balloon (322).

[0247] The inflatable transmission balloon (322) can be positioned toward the distal end (20) of the transmission device (314), wherein:

[0248] -Optionally, the inflatable transmission balloon (322) has a fixed maximum inflation diameter, and / or

[0249] -Optionally, the inflatable transmission balloon (322) carries one or more imaging markers visible through medical imaging, and / or

[0250] - Optionally, the inflatable transmission balloon (322) is equipped with one or more radio transponders for determining the position and / or orientation of the transmission (314) and / or operating mechanism shaft (310) by means of a space transponder detector.

[0251] The transmission device (314) can be made of any suitable biocompatible material such as medical-grade non-ferromagnetic stainless steel, tantalum, titanium, polycarbonate, PEEK, carbon fiber, fiber-reinforced polyaramid resin (e.g., Ixef (Solvay)), polyphenylene sulfone (PPSU) glass fiber, aluminum (coated), bioceramics such as aluminosilicate, styrene-acrylonitrile, and bioceramic polymer materials. The transmission device (314) can be made of the same material as the handle portion (316). The transmission device (314) at the proximal end can have the same diameter as the distal end of the handle portion (316).

[0252] The transmission device (314) can be formed from an imaging transparent material such as a polymer rod or tube. For ease of manufacture, the same material can be used to form the handle portion (316); this reduces imaging artifacts caused by the transmission device (314) in the vaginal region (606)—which is described in more detail below. Examples of suitable polymers include polycarbonate, polyphenylene sulfone (PPSU), and fiber-reinforced polyarylamide resins (e.g., Ixef (Solvay)). Other materials that can be used for the handle portion are glass fiber, carbon fiber, bioceramics such as aluminosilicate, styrene-acrylonitrile, bioceramic polymer materials, biocompatible polymeric rigid materials, etc. Figure 7 , 8 Examples of a control guide (300) formed by a polymer handle (316) and a transmission device (314) are depicted in 15, 16, 19-21, and both of them have a larger diameter (e.g. 0.8-2.5 cm) than the operating mechanism shaft (310) (which may be formed of a rigid metal such as titanium).

[0253] Where the transmission device (314) is not visible or is visible but insufficient to determine the position and / or orientation of the insertion device, the transmission device (314) may be provided with one or more imaging markers (350, a, b, c). This is helpful when performing imaging using imaging tools with a linear accelerator. The manipulation guide device (300), particularly the transmission device (314), may be provided with one or more imaging markers that can be identified by medical images. The imaging markers may be fixed relative to the transmission device (314), for example, on the inner surface, outer surface, or body of the transmission device (314). The imaging markers may be made of materials different from those of the transmission device (314), such as heavy metals like platinum, platinum-iridium, tantalum, tungsten, etc. Figure 16 One or more imaging markers (350, a, b, c) are shown on the transmitter (314).

[0254] Compared to a transmission device (314) made of more robust materials such as titanium or stainless steel, the polymer rod or tube used for the transmission device (314) can have a larger diameter (e.g., 1 cm). The polymer transmission device (314) can significantly help reduce artifacts and obtain high-quality images of the affected structures. Some imaging artifacts may arise from any imaging marks present on the transmission device (314), from the actuation mechanism shaft (310) which may be made of titanium corresponding to the inner portion of the cervix, and from any imaging marks set on the insertion device (204), but these will be less significant compared to if the entire manipulation guide device (300) were made of metal (titanium, non-ferromagnetic steel, coated aluminum, etc.).

[0255] When made of polymeric or ceramic materials, the transmission unit (314) material can be mixed with a radio-visible material such as barium sulfate to make it radio-visible on analog images and on control images performed before each radiation therapy session. To make it radio-visible, the surface of the transmission unit can also be covered with radio-visible longitudinal, circular, or spiral markings made of metal (e.g., fine titanium or tantalum wire) or of a material mixed with, for example, barium sulfate. When made of polymeric materials, the transmission unit can also contain radio-visible markings within its structure.

[0256] Depending on the location of the tube, such as the cervix or uterus, and the ease of access, an angle (α) of 90 to 240 degrees can be formed between the operating mechanism shaft (310) and the transmission device (314) (e.g. Figure 6 Depending on the ease of access, an angle (β) of 70 to 150 degrees can be formed between the handle (316) and the transmission device (314) (e.g. Figure 6 Depending on the ease of access, an angle (γ) of 0 or -90 to +90 degrees can be formed between the operating mechanism shaft (310) and the plane formed by the transmission device (314) and the handle (316) (e.g. Figure 6A For preferred dimensions and angles for various medical applications, see Tables 2 and 2a.

[0257]

[0258]

[0259] Table 2: Exemplary dimensions of elongated components and portions of the maneuvering guidance and delivery device balloon.

[0260] The size may exceed the range used for some presentation subjects, and it is not intended to be restrictive.

[0261]

[0262] Table 2a: Exemplary dimensions of elongated components and portions of the guiding and transmission balloon. Dimensions may extend beyond some of the subjects presented and are not intended to be limiting.

[0263] like Figure 26 As depicted, the insertion device (204) moves in response to movement of the operating mechanism shaft (310), which in turn moves in response to movement of the transmission device (314) and ultimately to movement of the handle (316). By positioning the insertion device (204), the position of the cervix (602), the position of the tissue surrounding the cervix, and the position of the uterus (604) can be adjusted and held in a fixed position. By inflating the expandable delivery balloon (322), the tissue surrounding the vaginal canal (606) can also be adjusted and held in a fixed position.

[0264] The control guide device (300), particularly the operating mechanism shaft (310) and / or transmission device (314) and / or handle (316) and / or transmission device balloon (if present) may be provided with one or more (e.g., two, three or more) location-determining radio transponders (352, a, b, c), the location of which can be determined and tracked using a space transponder detector.

[0265] The terms location determination radio transponder and transponder are used interchangeably in this document. A transponder is sometimes referred to as a beacon transponder. Figure 16 In this configuration, three transponders (352, a, b, c) are positioned at different locations and fixed to the outer surface or interior of the transmission device (314). The same transponders (352a-c) also serve as imaging markers (350a-c) because they are visible on medical images.

[0266] A transponder is a device that transmits electromagnetic pulses at a specific radio frequency that are detectable by a spatial transponder detector—typically comprising multiple spatially separated receivers (coils). The timing of the pulses detected by the multiple spatially separated receivers in a position transponder reader allows for accurate determination of the transponder's location. Transponders are sometimes referred to as beacon transponders. Transponders can receive electrical power inductively. Transponders can be powered by a built-in power source, for example, by a battery located on the handle of the manipulator. In the presence of more than one transponder, each transponder can transmit a signal at a different radio frequency. The orientation of the manipulator shaft (310) can also be determined when at least three individually identifiable transponders are positioned at different locations on the manipulator (300). Examples of such systems are described, for example, in US 9,248,003 B2 and US 9,072,895. The use of transponders reduces the need for multiple alignments of the manipulator shaft (310) and / or drive mechanism (314) with medical imaging prior to radiotherapy, thus reducing exposure to imaging radiation.

[0267] The transponder allows the position of the operating mechanism shaft (310) and / or drive (314) to be captured in real time during the simulation. The transponder also allows for real-time and automated guidance (e.g., via a robotic arm) of the position and / or orientation of the operating mechanism shaft (310) and / or drive (314) during treatment, aligning them with a reference posture determined during the simulation.

[0268] The transponder also allows for the manual guidance, alteration, and fixation of the position and / or orientation of the manipulator shaft (310) in real time based on position and orientation information captured by the space transponder detector. For example, a closed feedback loop (where the continuous input is the attitude of the manipulator guide (300), and therefore the attitude of the manipulator shaft (310), as determined by the radio transponder from one or more (e.g., two, three, or more) positions) can provide guidance to the operator to manually align the attitude of the manipulator guide (300) and therefore the attitude of the manipulator shaft (310) with the attitude determined during the simulation. In this case, the manipulator guide (300) can be attached via a handle (316) to a manually controllable positioning device (e.g., a manually adjustable positioning device with a lockable passive joint, or a positioning device for robot arm operation in manual zero-gravity mode). The same transponder and manual control can also allow the attitude of the manipulator guide (300) and therefore the attitude of the manipulator shaft (310) to be captured and stored during the simulation.

[0269] According to one aspect:

[0270] - At least a portion of the operating mechanism shaft (310) and / or one or more imaging markers carried by the insertion device (214) are visible through medical imaging, particularly through X-ray medical imaging and / or MR medical imaging.

[0271] and / or

[0272] - At least the distal portion of the transmission device (314) and / or one or more imaging markers carried by the insertion device (214) are visible by medical imaging, particularly by X-ray medical imaging or MR medical imaging.

[0273] and / or

[0274] - The drive unit (314) and / or operating mechanism shaft (310) are provided with one or more radio transponders carried by the insertion device (214) for determining the position and / or orientation of the drive unit (314) and / or operating mechanism shaft (310) by means of a space transponder detector.

[0275] Treatment is typically performed using a two-stage protocol. The first stage, called simulation, involves acquiring internal medical images of the subject, usually in three dimensions (e.g., via CT or MRI), while the subject is precisely aligned on a movable treatment simulation table relative to the imaging equipment. These medical images are used to plan the second stage of treatment. Radiologists use the images to determine which tissue structures will receive higher doses, lower doses, or are considered sensitive structures.

[0276] Treatment is typically performed using a linear accelerator, which distributes ionizing radiation for radiotherapy. Information obtained during simulation is used to set numerous parameters of the linear accelerator, including patient positioning, head movement angles, beam intensity, beam energy, and the profile shape of the blade collimator (if present). The linear accelerator can be combined with low-resolution medical imaging equipment (e.g., via CT, MRI) to rapidly acquire medical images of the subject, thereby confirming the location of tissues identified during simulation.

[0277] Medical imaging equipment (simulation) and linear accelerators are typically arranged in separate rooms.

[0278] The patient's position relative to the medical imaging equipment is recorded by marking the subject with tattoos at one or more locations, where projected laser reference lines are intersecting at known positions relative to the medical imaging equipment. The treatment room, containing the linear accelerator, is equipped with a similar pattern of projected laser reference lines that intersect at known positions relative to the linear accelerator; by aligning the tattoos with the laser lines, the subject's position relative to the linear accelerator is determined. Three-dimensional images recorded by the medical imaging equipment in one room can be transferred to the area used for radiotherapy via the linear accelerator in another room at a later time.

[0279] Prior to the initiation of radiotherapy, the patient is optionally examined under anesthesia, and typically, when the tumor is inoperable, the elongated member (210) of the insertion device (204) is inserted into the subject's tube (e.g., the cervix). Once in place, the sliding restraint device (220) (if present) is activated, for example, by suturing of the proximal stop member (250) and / or by inflating the balloon assembly (230) and / or by expanding the stent (240).

[0280] Prior to the simulation, once the patient is lying on the simulation table, the operating mechanism shaft (310) of the manipulation guide device (300) is introduced along the trailing guide line (218) and slidably inserted into the lumen (214) of the elongated member; this step can be performed by the subject himself. The transmission balloon (322), if present, is inflated using water (possibly mixed with 0.5–4% contrast agent). The subject is positioned on a body support (e.g., a simulation bed or table), the position and / or orientation of which is known and adjustable relative to the imaging device. The patient may be asked to lie in a comfortable position on the simulation table. This allows the patient to find his / her optimal position on the simulation table for himself during all subsequent treatment fractions. Contrast agent is usually injected intravenously to better visualize pelvic vascular structures, tumors, and lymph nodes. Once the subject's position is confirmed by the radiation oncologist, markings (e.g., tattoos, reflective markings) are placed on the subject's exposed skin as described above. This allows for precise positioning of the body relative to a body support using laser beams positioned along the patient's axis and sides during the radiation therapy session. Medical images obtained during the simulation allow the location of the tissue to be treated to be determined. The orientation and / or position of the elongated member (210) and / or the operating mechanism shaft (310) and / or the transmission section (314) can also be monitored by medical imaging and adjusted by corresponding movement of the handle section (316). The appropriate orientation and / or position of the elongated member (210) and / or the operating mechanism shaft (310) and / or the transmission section (which optimally positions the relevant tissue to be treated) can be determined and then used as a reference posture. During simulations performed primarily using CT scans (with less frequent use of MRI, or in a two-step process, fusing MRI images with simulated CT images), the optimal position of the positioning tool (200) can be determined. For example, if it is discovered that the cervix may be located too posteriorly, resulting in high-dose irradiation of the entire rectal area, a positioning device (such as a manual or robotic arm) can be used during simulation to gently bring the uterus to a more anterior position. This same position will be replicated in each subsequent treatment. After the simulation, the tumor and all organs are mapped onto each CT scan used for the treatment phase. This allows for prescribing treatment doses for each tumor tissue (cervix, uterus, bladder, lymph nodes, etc.) and prevents excessive doses from being delivered to healthy tissues (spinal cord, intestines, kidneys, etc.).

[0281] Calculations are typically performed by a computer to determine the direction, location, intensity, duration, and frequency of the radiation therapy, and are optimized taking into account the fixed position of the elongated member (210) and / or the actuating mechanism shaft (310). After the simulation, the actuating mechanism shaft (310) of the manipulating guide device (300), and possibly the transmission portion, is removed along the trailing guide line (218); this can be performed by the subject. The trailing guide line (218) can be affixed to the subject's skin, for example, on one of the patient's groins. The insertion device (204) remains in place for use in the treatment phase, for example, the following day or week. The position of tissue structures will be expected to have been moved before the actual treatment, as these factors, such as whether they are tethered to the pelvis, or whether the bladder is empty or full, or the colon is empty or full, all have an impact.

[0282] Just before the radiation therapy (e.g., hours, minutes), the subject is fitted with a body support (e.g., a treatment bed or table) to receive the therapeutic ionizing radiation and positioned relative to the ionizing radiation treatment head, for example using the aforementioned markings on the bare skin and axial and lateral laser beams. The operating mechanism shaft (310) of the manipulation guide (300) is introduced along the trailing guide line (218) and slidably inserted into the cavity (214) of the elongated member; this step can be performed by the subject himself. In fact, the patient will immediately feel discomfort upon making a sudden movement. The patient is more accurately aligned on the treatment table by aligning the pelvic bones with the position of the pelvic bones determined during simulation, typically with the aid of medical imaging (e.g., provided by an X-ray imager positioned relative to the ionizing radiation treatment head). The orientation and / or position of the elongated member (210) and / or the actuation mechanism shaft (310) are monitored by medical imaging (typically X-ray) and / or by a transponder, and can be adjusted by corresponding movement of the handle (316), for example using a positioning device (e.g., a manual device or a robotic arm), to align it with a reference posture. Once the orientation and / or position of the elongated member (210) and / or the actuation mechanism shaft (310) and / or the transmission part has been set, a treatment fraction (one of several) of external radiotherapy can begin. The position of the insertion device (204) remains fixed during the treatment session or fraction. At the end of the treatment fraction, the transmission balloon (322) is deflated by a technician or nurse, and the actuation mechanism shaft (310) of the manipulator (300) is removed along the trailing guide line (218); this can be performed by the subject. The insertion device (100) remains in place for use in the next radiotherapy session, for example, the following day or week. Such radiation therapy treatments can last for 1-35 fractions.

[0283] As mentioned earlier, the positioning tool (200) may be equipped with a transponder to allow real-time capture of the positioning tool (200)'s attitude during simulation or treatment. The transponder may be located on the insertion device (204) and / or the manipulation guide device (300). On the manipulation guide device, the transponder may be located on the operating mechanism shaft (310) and / or on or inside the transmission device (314) and / or on or inside the handle (316) and / or on the inflatable transmission balloon (322) (if present).

[0284] The transponder allows for real-time guidance of the positioning tool (200) during treatment, aligning it with a reference posture determined during simulation. This guidance can be manual, semi-automatic, or automated by a robotic arm. The transponder allows the position and / or orientation of the manipulator axis (310) or insertion device (204) to be guided, altered, and fixed in real time based on position and orientation information captured by a space transponder detector. For example, a closed feedback loop (where continuous input is the orientation of the manipulator axis (310) or insertion device (204) determined by one or more (e.g., two, three, or more) positions determined by a radio transponder) can provide guidance to align the orientation of the manipulator axis (310) or insertion device (204) with the orientation determined during simulation. This allows for fine-tuning of the orientation of the positioning tool (200) during in-situ simulation or treatment.

[0285] The transponder-guided real-time operation can be manual, providing information (e.g., graphical, audible, force feedback) to guide the operator to manually move and / or fix the positioning tool (200). In this case, the manipulator (300) can be attached to a manually controllable positioning device (e.g., a robotic arm operating in manual zero-gravity mode) via a handle (316). The same transponder and manual control also allow the attitude of the manipulator (300) to be captured and stored during simulation, and thus the attitude of the manipulator shaft (310).

[0286] The transponder can provide real-time guidance automatically, thereby providing information to the robotic arm to automatically move the positioning tool (200) via activation of the robotic arm joint.

[0287] Real-time guidance can be semi-automatic, thereby providing information to the robotic arm and operator to allow for partially automatic and partially manual movement of the positioning tool (200).

[0288] The transponders and imaging markers function well below the subject's surface. It is not necessary for all transponders to be placed inside the patient. Transponders located on or inside the positioning tool (200) do not all need to be inside the body. For example, one or two transponders may be located on or inside the positioning tool (200) that will be part of the patient's body (e.g., on the insertion device (204), the actuation mechanism shaft (310), or on or inside the distal portion of the drive (314) of the manipulation guide (300), and one or two transponders may be located outside the patient's body (e.g., on or inside the proximal portion of the drive (314) of the manipulation guide (300).

[0289] Using certain existing technologies, transponders can be implanted in the body to track the position of organs. This positioning tool (200) avoids the need for implantation; the transponders are located on or within a portion of a positioning tool (e.g., an insertion device (204), a manipulation guide device (300)) outside the body, and are only temporarily introduced into the body for a few minutes during each fraction of treatment. These transponders track objects within the body; they are located on the objects; they are not implanted; and some of them (one or two) can remain outside the body to track said objects. Therefore, it avoids the need to implant transponders into the subject's body.

[0290] Wearable insertable devices facilitate strictly reproducible positioning of the tube and surrounding tissues, reducing the need for beam widening to accommodate tissues that typically change position between treatment fractions. It also secures the tube and surrounding tissues during irradiation. In practice, safety margins can be reduced to millimeter levels instead of centimeter levels, significantly minimizing irradiation of adjacent organs and tissues. For example, in the case of cervical treatment, irritation to the bladder, rectum, intestines, and pelvic wall is reduced. Because the beam has a more concentrated (i.e., reduced) area, the radiation dose can be increased during external radiotherapy procedures (conformal radiotherapy), thus avoiding the need for brachytherapy. For example, for a cervical tumor 4 cm high and 5 cm in diameter, using the classic 16 mm safety margin, the volume treated with a high dose would be 380 cm³. 3 By utilizing a positioning tool (200) that allows the cervix to be brought to the same position before each radiation fraction, a tighter margin (e.g., 4 mm) can be achieved, and the high-dose volume can be reduced to 126 cm. 3 (A 3.3-fold reduction). This has a very beneficial effect on reducing toxicity.

[0291] Wearable insertion devices eliminate the need for patient sedation prior to radiotherapy. This reduces patient trauma and eliminates repetitive trauma for each treatment. The guide wire allows the user (radiation oncologist, physician, radiation technician, subject) to easily position and manipulate the guide device from outside the subject. For gynecological applications, the need for a speculum is eliminated. Patients can also insert the guide device themselves. The guide wire allows for repeated installation and removal of the guide device before and after treatment. Although the wearable insertion device is located in situ, such as in the cervix, it still provides access to the lumen of a slender member (214).

[0292] This article also provides a computer-implemented method for improving the accuracy of site-specific radiotherapy on body tissues of subjects targeted by radiotherapy, comprising:

[0293] - Receive data on the following:

[0294] ○ The position and / or orientation of the positioning tool (200), wherein the insertion device (204) is located inside the subject's tube,

[0295] Based on the reference posture of the positioning tool (200), instructions are output to the positioning device (such as a robotic arm) to adjust the position and / or orientation of the positioning tool (200), thereby adjusting the position and / or orientation of the tube and body tissue, wherein the reference posture is determined during the treatment simulation procedure.

[0296] This article also provides a computer-implemented method for improving the accuracy of site-specific radiotherapy on body tissues of subjects targeted by radiotherapy, comprising:

[0297] - Receive data on the following:

[0298] ○ The position and / or orientation of the insertion device (204) located inside the tube, and / or

[0299] ○ The position and / or orientation of the operating mechanism shaft (310) of the manipulation guide (300) located within the elongated member cavity (214) of the insertion device (204).

[0300] - Output instructions to a positioning device (e.g., a robotic arm) to adjust the position and / or orientation of the insertion device (204) using a manipulation guide (300) based on a reference posture of the insertion device (204) and / or the actuation mechanism shaft (310) and / or the transmission part (314), thereby adjusting the position and / or orientation of the tube and body tissue, wherein the reference posture is determined during a treatment simulation procedure.

[0301] The position and / or orientation of the positioning tool (200) and / or insertion device (204) and / or operating mechanism shaft (310) can be determined based on medical images taken just before radiotherapy (e.g., minutes or hours prior), or based on the position of the transponder attached to the transmission or handle of the positioning tool (200) and / or insertion device (204) and / or operating mechanism shaft (310) and / or manipulation guide. The reference posture can be determined during a simulation of treatment relative to the patient's structure (bones, pelvic bones). Radiotherapy can be administered in fractions.

[0302] This article also provides a computer-implemented method for improving the accuracy of site-specific radiotherapy on body tissues of subjects targeted by radiotherapy, comprising:

[0303] (a) Receiving data via computer regarding the following:

[0304] ○ The position and / or orientation of the positioning tool (200), wherein the insertion device (204) is located within the subject's tube, wherein the position and / or orientation of the positioning tool (200) is determined according to the following:

[0305] ■ One or more transponders (260, a, b, c) attached to the insertion device (204), and / or

[0306] ■ One or more transponders (352a, b, ...) attached to the steering guidance device (300)

[0307] c), and / or

[0308] • One or more optically detectable landmarks (346i-iv, a, b, c) attached to the steering guide (300);

[0309] (b) Output the following real-time instructions to the computer graphical user interface:

[0310] The position and / or orientation of the positioning tool (200) are compared with the reference attitude of the positioning tool (200) determined during the simulation procedure.

[0311] This article also provides a computer-implemented method for improving the accuracy of site-specific radiotherapy on body tissues of subjects targeted by radiotherapy, comprising:

[0312] (a) Receiving data via computer regarding the following:

[0313] ○ The position and / or orientation of the insertion device (204) located inside the tube, and / or

[0314] ○ The position and / or orientation of the operating mechanism shaft (310) of the manipulation guide (300) located in the elongated member cavity (214) of the insertion device (204);

[0315] The position and / or orientation of the insertion device (204) or the operating mechanism shaft (310) are determined according to the following:

[0316] ■ One or more transponders (260, a, b, c) attached to the insertion device (204), and / or

[0317] or

[0318] ■ One or more transponders (352, a, b, c) attached to the control and guidance device (300), and / or

[0319] ■ One or more optically detectable landmarks (346i to iv) attached to the maneuvering guide device (300);

[0320] (b) Output the following real-time instructions to the computer graphical user interface:

[0321] The position and / or orientation of the insertion device (204), and / or

[0322] Position and / or orientation of the operating mechanism shaft (310)

[0323] The orientation is compared with the reference orientation of the insertion device (204) and / or the operating mechanism shaft (310) determined during the simulation process.

[0324] A computing device or system is also provided, which is configured to perform the computer-implemented methods described herein.

[0325] A computer program or computer program product is also provided, having instructions that, when executed by a computing device or system, cause the computing device or system to perform the computer-implemented method described herein.

[0326] A computer-readable medium is also provided on which a computer program as described herein is stored.

[0327] A computer-readable medium is also provided, having stored thereon instructions that, when executed by a computing device or system, cause the computing device or system to perform the computer-implemented methods described herein.

[0328] A data stream representing the computer program or computer program product described herein is also provided.

[0329] A system is also provided, comprising:

[0330] - As described in this article, the positioning tool (200),

[0331] - A positioning device for adjusting and fixing the position and / or orientation of the handle (316) and the operating mechanism shaft (310) of the positioning tool (200).

[0332] in

[0333] The handle (316) is configured to be detachably attached to the positioning device, and

[0334] The positioning device is a robotic arm.

[0335] This article also provides a method for treating body tissues of a subject that are the target of radiotherapy using site-specific fractionated radiotherapy, including:

[0336] (a) Receiving data via computer regarding the following:

[0337] ○ The position and / or orientation of the positioning tool (200), wherein the insertion device (204) is located inside the tube, and / or

[0338] (b) The computer outputs instructions to the positioning device (e.g., a robotic arm) to adjust the positioning tool (200) according to the reference pose of the positioning tool (200), thereby adjusting the position and / or orientation of the tube and body tissue to reproduce the positioning tool (200) as it was during the treatment simulation process;

[0339] (c) Maintain the position and / or orientation of the positioning tool (200) during the fractionation of site-specific fractionated radiotherapy;

[0340] (d) Remove the manipulation guide device (300); and

[0341] (e) Repeat steps (a) through (d) in one or more subsequent fractions of site-specific fractionated radiotherapy.

[0342] This article also provides a method for treating body tissues of a subject that are the target of radiotherapy using site-specific fractionated radiotherapy, including:

[0343] (a) Receiving data via computer regarding the following:

[0344] ○ The position and / or orientation of the insertion device (204) located inside the tube, and / or

[0345] ○ The position and / or orientation of the operating mechanism shaft (310) of the manipulation guide (300) located in the elongated member cavity (214) of the insertion device (204);

[0346] (b) By outputting instructions to a positioning device (e.g., a robotic arm) via a computer to adjust the position and / or orientation of the insertion device (204) and / or the operating mechanism shaft (310) and / or the transmission part (314) using a manipulation guide device (300), thereby adjusting the position and / or orientation of the tube and body tissue to reproduce the position of the insertion device (204) and / or the operating mechanism shaft (310) and / or the transmission part (314) as it is during the treatment simulation process;

[0347] (c) Maintaining the position and / or orientation of the insertion device (204) during the fractionation of site-specific fractionated radiotherapy;

[0348] (d) Remove the manipulation guide device (300); and

[0349] (e) Repeat steps (a) through (d) in one or more subsequent fractions of site-specific fractionated radiotherapy.

[0350] This article also provides a method for treating body tissues of a subject that are the target of radiotherapy using site-specific fractionated radiotherapy, including:

[0351] (a) Determine:

[0352] ○ The position and / or orientation of the positioning tool (200), wherein the insertion device (204) is located inside the tube of the subject, wherein the position and / or orientation of the positioning tool (200) is determined by one or more transponders (260, a, b, c) and / or one or more optically detectable marks (346i-iv) attached to the positioning tool (200);

[0353] (b) Output a real-time indication of the position and / or orientation of the positioning tool (200) to a computer graphical user interface, which is compared with a reference orientation of the positioning tool (200) determined during the simulation process;

[0354] (c) Manually adjust the position and / or orientation of the positioning tool (200) until it matches the reference orientation of the positioning tool (200);

[0355] (d) Maintain the position and / or orientation of the positioning tool (200) during the fractionation of site-specific fractionated radiotherapy;

[0356] (e) Remove the manipulation guide (300) from the positioning tool (200); and

[0357] (f) Repeat steps (a) through (e) in one or more subsequent fractions of site-specific fractionated radiotherapy.

[0358] This article also provides a method for treating body tissues of a subject that are the target of radiotherapy using site-specific fractionated radiotherapy, including:

[0359] (a) Determine:

[0360] ○ The position and / or orientation of the insertion device (204) located inside the tube, and / or

[0361] ○ The position and / or orientation of the operating mechanism shaft (310) of the manipulation guide (300) located in the elongated member cavity (214) of the insertion device (204);

[0362] The position and / or orientation of the inserter (204) or the operating mechanism shaft (310) are determined according to the following:

[0363] ■ One or more transponders (260, a, b, c) attached to the insertion device (204), and / or

[0364] or

[0365] ■ One or more transponders (352, a, b, c) attached to the control and guidance device (204), and / or

[0366] ■ One or more optically detectable landmarks (346, i-iv) attached to the maneuvering guide device (300)

[0367] (b) Output the following real-time instructions to the computer graphical user interface:

[0368] The position and / or orientation of the insertion device (204), and / or

[0369] Position and / or orientation of the operating mechanism shaft (310)

[0370] Compare with the reference orientation of the insertion device (204) and / or the operating mechanism shaft (310) determined during the simulation process.

[0371] (c) Manually adjust the position and / or orientation of the insertion device (204) and / or the operating mechanism shaft (310) until it matches the reference orientation of the insertion device (204) and / or the operating mechanism shaft (310).

[0372] (d) Maintaining the position and / or orientation of the insertion device (204) during the fractionation of site-specific fractionated radiotherapy;

[0373] (e) Remove the manipulation guide device (300); and

[0374] (f) Repeat steps (a) through (e) in one or more subsequent fractions of site-specific fractionated radiotherapy.

Claims

1. A positioning tool (200) for assisting a subject in an external radiotherapy procedure comprising one or more external radiotherapy sessions, the positioning tool (200) comprising: - An insertion device (204) having a proximal end (40) and a distal end (20), the insertion device comprising: - An elongated member (210) configured to be inserted through an inlet into a tube (602) connected to the body tissue (610) of the subject, and having an elongated member cavity (214) configured to receive an operating mechanism shaft (310) of a manipulation guide (300); and - A guide wire (218) for guiding the operating mechanism shaft (310) from outside the inlet of the tube into the inner cavity (214), wherein the guide wire (218) is at least partially disposed within the inner cavity (214) and is confined at or toward the distal end (20) of the guide wire (218) to limit or prevent the guide wire (218) from sliding relative to the inner cavity (214) in the proximal direction. - A removable manipulation guide (300) having a proximal end (40) and a distal end (20), comprising: - An operating mechanism shaft (310) located at the distal end (20) is configured to be repeatedly and removably inserted into the elongated member cavity (214) along the guide line (218), and A handle (316) fixedly associated with the operating mechanism shaft (310) at the proximal end (40) is used to control the position and / or orientation of the operating mechanism shaft (310). The operating mechanism shaft (310) includes a body having a guide line channel (312) for sliding along the guide line (218), the guide line channel (312) being at least partially disposed along the length of the body. The positioning tool (200) is configured to move and / or fix the subject’s tubes (602) and body tissues (610) for the external radiotherapy procedure.

2. The positioning tool (200) according to claim 1, wherein the tube is the subject's cervix and / or uterus and / or vaginal fornix material and the body tissue is tissue contained in the pelvic region, and the inlet to the tube is the inlet to the tube inside the cervix or vaginal fornix material.

3. The positioning tool (200) according to claim 1 or 2, wherein the elongated member (210) is provided with at least one sliding limiting device (220) configured to reduce or prevent the elongated member (210) from sliding relative to the tube.

4. The positioning tool (200) according to claim 3, wherein at least one sliding limiting device (220) is an inflatable balloon assembly (230) comprising one or more inflatable balloons (231, -a to -h), or an inflatable stent (240), a distal protrusion (245), or a stop member (250).

5. The positioning tool (200) according to claim 4, wherein the inflatable balloon assembly (230) comprises one or more inflatable balloons (231, -a to -h), each having an inflatable balloon cavity (232) in fluid communication with an inflatable cavity (234) extending in the proximal (40) direction via an inflatable tube (236).

6. The positioning tool (200) according to claim 5, wherein the guide line (218) is the expansion tube (236).

7. The positioning tool (200) according to claim 4, wherein it is provided with at least two sliding limiting devices (220): - A first sliding limiting device, comprising a stop member (250) disposed at the proximal end (40) of the elongated member (210) and configured to abut against the inlet of the tube, and - A second sliding limiting device, comprising a device disposed at the distal end (20) of the elongated member (210): -The inflatable balloon assembly (230), or -The distal protrusion (245), or -The expandable support (240).

8. The positioning tool (200) according to claim 7, wherein the stop member (250) is provided with one or more suturing passages (252) for suturing to the inlet of the tube.

9. The positioning tool (200) according to claim 1, wherein the guide line (218) is non-removably or removably attached to the cavity (214).

10. The positioning tool (200) according to claim 1, wherein the guide line (218) is a relaxation tube (237) configured to receive a stiffening tube wire.

11. The positioning tool (200) according to claim 1, wherein: -At least a portion of the insertion device (204) or by one or more imaging markers carried thereon is visible through medical imaging. and / or - At least a portion of the elongated member (210) or by one or more imaging markers thereon is visible through medical imaging. and / or - The insertion device (204) or elongated member (210) is provided with one or more radio transponders for determining the position and / or orientation of the insertion device (204) and / or elongated member (210) in real time by means of a space transponder detector, or - The elongated member (210) is not visible by X-ray imaging.

12. The positioning tool (200) according to claim 11, wherein at least a portion of the insertion device (204) or one or more imaging markers thereon are visible by X-ray medical imaging and / or by MR medical imaging.

13. The positioning tool (200) according to claim 11, wherein at least a portion of the elongated member (210) or one or more imaging markers thereon are visible by X-ray medical imaging and / or by MR medical imaging.

14. The positioning tool (200) according to claim 1, wherein the guide line channel (312) is a groove or cavity in the operating mechanism shaft (310).

15. The positioning tool (200) according to claim 1, wherein the main body of the operating mechanism shaft (310) is rigid, and the elongated member (210) is flexible and rigidified by being inserted into the elongated member cavity (214) of the operating mechanism shaft (310).

16. The positioning tool (200) according to claim 1, wherein the handle (316) is configured to be attached to a positioning device, the positioning device being configured to adjust and fix the position and / or orientation of the operating mechanism shaft (310).

17. The positioning tool (200) according to claim 16, wherein The handle (316) is provided with a grip positioning device (330), which is configured to cooperate with the end effector accessory of the positioning device for detachably, repeatedly and reproducibly attaching the handle (316) to the positioning device.

18. The positioning tool (200) according to claim 1, wherein the removable manipulation guide (300) further comprises: - A transmission device (314) that connects the handle (316) to the shaft (310) of the operating mechanism.

19. The positioning tool (200) according to claim 18, wherein the removable manipulation guide (300) further comprises: - An inflatable transmission device balloon (322) is disposed toward the distal end (20) of the transmission device (314).

20. The positioning tool (200) according to claim 19, wherein: - The inflatable transmission device balloon (322) has a fixed maximum expansion diameter.

21. The positioning tool (200) according to claim 19, wherein: - The inflatable transmission balloon (322) has one or more imaging markers visible through medical imaging.

22. The positioning tool (200) according to claim 19, wherein: - The inflatable transmission balloon (322) is equipped with one or more radio transponders for determining the position and / or orientation of the transmission (314) and / or the operating mechanism shaft (310) in real time via a space transponder detector.

23. The positioning tool (200) according to claim 1, wherein: - At least a portion of the operating mechanism shaft (310) and / or one or more imaging markers carried by the operating mechanism shaft (310) are visible through medical imaging; and / or - At least the distal portion of the transmission device (314) and / or one or more imaging markers carried by the operating mechanism shaft (310) are visible through medical imaging; and / or - The transmission device (314) and / or the operating mechanism shaft (310) are provided with one or more radio transponders for determining the position and / or orientation of the transmission device (314) and / or the operating mechanism shaft (310) in real time by means of a space transponder detector.

24. The positioning tool (200) according to claim 23, wherein: - At least a portion of the operating mechanism shaft (310) and / or one or more imaging markers carried by the operating mechanism shaft (310) are visible by X-ray medical imaging and / or magnetic resonance MR medical imaging.

25. The positioning tool (200) according to claim 23, wherein: - At least the distal portion of the transmission device (314) and / or one or more imaging markers carried by the operating mechanism shaft (310) are visible by X-ray medical imaging or MR medical imaging.

26. The positioning tool (200) according to claim 1, wherein the handle (316) of the manipulation guide (300) is provided with a docking beacon (340) configured to provide real-time information about the position of the manipulation guide (300) to allow manual, semi-automatic or automatic docking guidance between the positioning device and the handle (316).

27. The positioning tool (200) according to claim 26, wherein the docking beacon (340) is configured to provide real-time information about the orientation of the manipulation guide (300) to allow manual, semi-automatic or automatic docking guidance of the positioning device with the handle (316).

28. The positioning tool (200) according to claim 1, wherein the tube (602) is moved by the positioning tool (200): - During an external radiotherapy treatment, body tissue (608) connected to the tube (602) is introduced into an ionizing radiation beam emitted by the ionizing radiation treatment head (518). or - During an external radiotherapy treatment, body tissue (608) connected to the tube (602) is moved away from the ionizing radiation beam emitted by the ionizing radiation treatment head (518).

29. A system comprising: - The positioning tool (200) according to any one of claims 1 to 28; - A positioning device for adjusting and fixing the position and / or orientation of the handle (316) and the operating mechanism shaft (310) of the positioning tool (200); in The handle (316) is configured to be detachably attached to the positioning device; and The positioning device is a robotic arm.

Images