Radiation therapy applicator

Abstract

An applicator for delivering radiotherapy seeds to a tumor in a patient through an elongated needle (104). The elongated needle has a needle handle (204) and a needle tube having a predetermined length for insertion into the patient. The applicator has an elongated applicator tube (106) designed to pass through the elongated needle and defining an internal channel for receiving one or more radiotherapy seeds (110), an applicator handle (210) configured to be attached to the needle handle (204), and a stylet (108) within the elongated applicator tube. The elongated applicator tube is longer than the elongated needle.

Description

Technical Field

[0001] [Cross-Reference to Related Applications] This application claims the benefit of U.S. Provisional Patent Application 63 / 159,499 filed on March 11, 2021, which is incorporated into this application by reference.

[0002] The present invention relates generally to radiation therapy, and in particular to a method of implanting a radiation therapy source into a tumor located in a visceral organ.

Background Art

[0003] Alpha particle emitters are a powerful means of radiation therapy for certain types of tumors, including malignant tumors. Appropriate delivery of seeds incorporating alpha particle emitters is critical to successful treatment. Delivery should accurately place the seeds within the tumor without early exposure of the patient's tissue and the like to radioactive materials or other unhealthy substances.

[0004] One type of alpha therapy source is a diffusing alpha-emitter radiation therapy (DaRT) source loaded with radium-223 or radium-224 atoms, which has a half-life that is neither too long nor too short for therapeutic purposes.

[0005] U.S. Patent No. 8,834,837 to Kelson describes a method of DaRT treatment.

[0006] PCT Publication No. WO2015 / 136192 entitled "Brachytherapy (brachytherapy) apparatus and associated treatment methods" describes delivery of a radioactive material container through a needle inserted into an endoscope channel.

[0007] U.S. Patent No. 4,532,935 to Wang describes a bronchoscopic needle comprising an outer catheter, a needle attached to an inner catheter inside the outer catheter, and a stylet passing through the needle. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Publication No. 8,834,837 [Patent Document 2] WO2015 / 136192 publication [Patent Document 3] U.S. Publication No. 4,532,935 [Overview of the project] [Means for solving the problem]

[0009] According to embodiments of the present invention, an applicator for delivering radiotherapy seeds to a patient's tumor through an elongated needle is provided, the elongated needle having a needle handle and a needle tube having a predetermined length for insertion into the patient, The applicator is, An elongated applicator tube designed to pass through an elongated needle, comprising an elongated applicator tube that constitutes an internal channel for receiving one or more radiotherapy seeds, An applicator handle configured to be attached to the needle handle, The stylet inside the elongated applicator tube, It has, The slender applicator tube is longer than the slender needle.

[0010] Optionally, the elongated applicator tube has a flexibility unsuitable for insertion into a patient, but can pass through the internal channels of the elongated needle when the elongated needle is in the patient. Optionally, the elongated applicator tube has a length such that its distal end is close to the distal end of the elongated needle when the applicator handle is attached to the needle handle. Optionally, the elongated applicator tube has a length of at least 20 centimeters. Optionally, the applicator further comprises a seed dispensing unit configured to grasp the applicator handle and the stylet handle in a manner that allows the applicator handle to move relative to the stylet handle so that the stylet pushes seeds out from the distal end of the elongated applicator tube. Optionally, the seed dispensing unit comprises a casing configured to grasp the stylet handle and a slidable holder coupled to the applicator handle and configured to slide relative to the casing.

[0011] Optionally, the seed dispensing unit has a guide handle that moves the applicator handle relative to the stylet handle when moved by the user along the axis of the elongated applicator tube. Optionally, the seed dispensing unit is configured to limit the movement of the guide handle along the axis of the elongated applicator tube in one stroke to the length of a single seed. Optionally, the seed dispensing unit is configured to require lateral movement of the guide handle to allow further movement of the guide handle along the axis of the elongated applicator tube after moving the length of a single seed. Optionally, the seed dispensing unit is configured to retract the applicator handle while the stylet handle is held in place. Optionally, the elongated applicator tube has a length of at least 50 centimeters.

[0012] Furthermore, according to embodiments of the present invention, a seed distribution unit is provided, and this seed distribution unit is An applicator handle holder configured to grasp the handle of an elongated applicator containing multiple radiotherapy seeds at its distal end, A stylet handle gripper configured to grasp the stylet handle inside a long, slender applicator, A casing configured to allow the applicator handle holder to move relative to the stylet handle gripper, such that the stylet pushes the seed out from the distal end of the elongated applicator, It has, The casing is configured to limit the continuous movement of the applicator handle holder relative to the stylet handle grip to the length of a single seed, so that any further movement is permitted only after an adjustment action by a human user.

[0013] Optionally, the applicator handle holder has a guide handle used by the user to move the applicator handle holder in a first direction relative to the stylet handle gripper, and the casing requires movement in a second direction different from the first direction in order to move in the first direction beyond the length of a single seed. Optionally, the second direction is perpendicular to the first direction. Optionally, the applicator handle holder has a ratchet that prevents the applicator handle holder from moving backward after it has moved the length of a seed, unless a ratchet release button is pressed. Optionally, the casing has one or more ball plungers that limit the continuous movement of the applicator handle holder relative to the stylet handle gripper to the length of a single seed.

[0014] Furthermore, according to embodiments of the present invention, a system is provided for delivering radiotherapy seeds to a tumor, the system comprising an endoscope forming an elongated channel, an elongated needle passing through the elongated channel of the endoscope, an elongated applicator passing through the elongated needle and forming an internal channel for receiving one or more radiotherapy seeds, and a stylet within the elongated applicator.

[0015] Optionally, the system comprises a seed delivery unit configured to receive a needle handle at one end and a stylet handle at the other end. Optionally, the seed delivery unit comprises a needle handle holder configured to hold the needle handle, and a proximal compartment that receives the stylet handle. Optionally, the seed delivery unit is configured to push the needle handle holder toward the proximal compartment by a fixed length sufficient to dispense a single seed from an applicator.

[0016] Further, according to an embodiment of the present invention, there is provided a method of delivering a radiotherapy seed to a viscus of a patient, the method comprising: providing an elongate applicator having a length sufficient to extend from outside the patient to the viscus, the elongate applicator comprising one or more radiotherapy seeds at a distal end thereof and a stylet extending through the elongate applicator from a proximal end thereof to the one or more radiotherapy seeds; inserting the elongate applicator into an elongate needle; puncturing the viscus with the elongate needle; dispensing at least one of the seeds into the patient by retracting the elongate needle and the elongate applicator relative to the stylet; .

[0017] Optionally, the step of inserting the elongate applicator into the elongate needle is performed while the elongate needle extends from outside the patient to the viscus. Optionally, the step of inserting the elongate applicator into the elongate needle is performed while the elongate needle is completely outside the patient. Optionally, the method comprises guiding the needle through an endoscope to the vicinity of the viscus. Optionally, the method comprises connecting the needle handle to the handle of the applicator prior to dispensing at least one of the seeds. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] [Figure 1]It is a partial cross-sectional view of a system for delivering radiotherapy seeds according to an embodiment of the present invention. [Figure 2] It is a schematic diagram of the proximal end of a needle in a seed distribution unit according to an embodiment of the present invention. [Figure 3] It is a schematic diagram of the seed distribution unit of FIG. 2 without a needle handle according to an embodiment of the present invention. [Figure 4] It is a schematic diagram of a cradle needle holder for holding a needle handle according to an embodiment of the present invention. [Figure 5] It is an upside-down schematic diagram of a cradle needle holder provided with a guide used for moving the needle holder according to an embodiment of the present invention. [Figure 6] It is a schematic diagram of the back side of a casing of a seed distribution unit in addition to a guide handle according to an embodiment of the present invention. [Figure 7] It is a schematic diagram of a slide frame and a corresponding guide according to an embodiment of the present invention. [Figure 8A] It is a schematic diagram of a ratchet mechanism according to an embodiment of the present invention. [Figure 8B] It is a schematic diagram of a ratchet mechanism according to an embodiment of the present invention. [Figure 9] It is a flowchart of operations performed when implanting a radiotherapy seed into a patient's tumor according to an embodiment of the present invention. [Figure 10A] It is a schematic diagram of an applicator kit according to an embodiment of the present invention. [Figure 10B] It is a schematic diagram of the proximal end of the applicator kit of FIG. 10A with a first fixing element removed according to an embodiment of the present invention. [Figure 11A] It is a schematic top view of a seed distribution unit according to an embodiment of the present invention. [Figure 11B] It is a schematic side view of the seed distribution unit of FIG. 11A with a needle handle and a sheath handle mounted therein. [Figure 12A] It is a side view of the seed distribution unit of FIG. 11A with a stylet carrier mounted therein according to an embodiment of the present invention. [Figure 12B] Figure 11A is a top view of a seed distribution unit according to an embodiment of the present invention, in which a stylet carrier is installed inside. [Modes for carrying out the invention]

[0019] One aspect of several embodiments of the present invention relates to the delivery of radiotherapy seeds to a patient's internal organs in three tubes, each independently operable, with one in between. Delivering the radiotherapy seeds in three tubes improves the flexibility of delivery. In some embodiments, the outer tube is an endoscope, the middle tube is an elongated needle, and the inner tube is an applicator for carrying the seeds. The use of an elongated needle in addition to the endoscope allows the endoscope's properties, such as robustness and visibility, to reach the vicinity of the tumor, while the elongated needle's greater flexibility and smaller diameter allow it to reach the tumor itself. By using an elongated applicator separate from the elongated needle to carry the seeds, the seeds can be delivered to the distal end of the elongated needle by rubbing them against the inner wall of the elongated needle, without passing the seeds through the internal channels of the elongated needle while the needle is inside the patient. Some radiotherapy seeds have active radioactive particles on their outer surface, so when the seeds are passed through the internal channels of an elongated needle, a significant portion of their activity can be lost due to friction against the inner wall of the needle. By inserting a separate elongated applicator, additional seeds can be delivered to the tumor beyond the seeds originally attached to the elongated needle. Furthermore, using an elongated applicator allows the distal end of the elongated needle to be delivered to the tumor without the seeds inside, enabling further flexibility of the elongated needle as needed.

[0020] One aspect of several embodiments of the present invention relates to a system for delivering seeds to a patient's internal organs, comprising two elongated tubes of substantially equal length, one of which houses the other. Optionally, each elongated tube has a handle, which is configured to be joined together so that the distal ends of the elongated tubes are close to each other when the handles are joined. In some embodiments, the inner tube carries one or more radiotherapy seeds and a stylet used to push the seeds out from the distal end of an applicator.

[0021] Figure 1 is a partial cross-sectional view of a system 100 for delivering one or more radiotherapy seeds 110 according to an embodiment of the present invention. The system 100 has an endoscope 102 suitable for insertion into a patient. An elongated needle 104 having a sharp edge 114 (schematically shown in Figure 1), such as those used in the art for taking biopsies, is inserted through a channel in the endoscope 102. The elongated needle 104 optionally comprises an outer sheath 118, in which the elongated needle 104 can slide between a delivery state in which the sharp edge 114 is entirely inside the sheath 118 and an operating state in which the sharp edge 114 is outside the sheath, as shown in Figure 1.

[0022] The applicator 106 (which carries the seeds 100) passes through the needle 104. The stylet 108 inside the applicator 106 is used to push the seeds 110 into the patient. As shown in the figure, the applicator 106 carries five seeds 110, each having an overall length of 0.5 to 2 centimeters. The applicator 106 may carry fewer than five or fewer than three seeds 110, or more than five or more than ten seeds 110.

[0023] The needle 104 is shown within the channel of the endoscope 102, but in some cases, the needle 104 may extend beyond the distal end of the endoscope and enter areas that are too narrow or inaccessible in the endoscope 102. Therefore, overall, at least the distal portion of the elongated needle 104 has sufficient rigidity to be independently maneuverable within the patient, while also having sufficient flexibility to be manipulated through winding, narrow body channels. In some embodiments, the elongated needle 104 has an outer diameter of less than 1.7 mm, less than 1.2 mm, or less than 1 mm, for example, 0.8 mm, and an inner diameter of less than 1.25 mm, less than 1 mm, less than 0.8 mm, or less than 0.6 mm, for example, 0.45 mm. Alternatively or in addition, the elongated needle 104 may have a relatively large outer diameter, for example, greater than 1 mm, greater than 1.2 mm, or greater than 1.5 mm.

[0024] To fit the elongated needle 104, the applicator 106 has an outer diameter less than or equal to the inner diameter of the elongated needle 104. The inner diameter of the applicator 106 is large enough to hold a seed 110 having a diameter optionally greater than 0.3 mm, such as 0.37 mm. The walls of the applicator 106 optionally have a thickness of less than 0.2 mm, less than 0.15 mm, or less than 0.1 mm. Since the applicator 106 is intended to pass through the internal channel of the needle 104, in some embodiments the applicator 106 is very soft and not suitable for passing through the patient on its own. Furthermore, the applicator 106 optionally has high flexibility, and as a result, when placed inside the needle 104, the combined flexibility of the needle 104 and the applicator 106 makes them maneuverable within the patient. Alternatively or in addition to this, if a complex operation is required, the applicator 106 is removed from the needle 104 and returned once the needle is properly positioned. In some embodiments, the applicator 106 has a braided or unbraided composite polyimide tube. The applicator 106 may also be removed from the needle 104 to replenish the seeds 110 at its distal end and reinserted into the needle 104 after the seeds have been replenished. The elongated tube of the applicator 106 is constructed to be sufficiently rigid to allow for removal and reinsertion.

[0025] In some embodiments, the length of the applicator 106 is the same as the length of the elongated needle 104 (e.g., a difference of 20 millimeters or less or 10 millimeters or less), so that when the applicator 106 is inserted into the internal channel of the needle 104 and their handles are connected, the distal end of the applicator 106 coincides with the distal end of the needle 104 (within 10 millimeters or within 5 millimeters). In some embodiments, the applicator 106 is longer than the needle 104 by the length of the needle 104's handle (within 5 millimeters).

[0026] In other embodiments, the applicator 106 is longer than the elongated needle 104 to such an extent that it extends beyond the end of the needle 104 by at least 2 centimeters, at least 5 centimeters, or at least 8 centimeters when the handle of the elongated needle 104 is attached. Optionally, the distal end of the applicator 106 has a hard material such as nitinol that can be used to penetrate the tumor with a sharp needle. Inserting the applicator 106 itself into the tumor has the advantage of reducing the diameter of the entry hole. In some embodiments, the distal end of the applicator 106 is pre-shaped at a specific angle to reach specific locations and / or directions that are difficult to access with a needle.

[0027] The elongated tubes of the needle 104 and applicator 106 have lengths of at least 20 centimeters, at least 50 centimeters, at least 80 centimeters, at least 100 centimeters, at least 120 centimeters, or at least 150 centimeters. The stylet 108 is slightly longer overall than the applicator 106 so that it can push out all the seeds 110 from the distal end of the applicator.

[0028] Figure 2 is a schematic diagram of the proximal end of the needle 104 in a seed dispensing unit 200 according to an embodiment of the present invention. The seed dispensing unit 200 is designed so that a human user can controllly move the needle 104 and applicator 106 relative to a stylet 108 in order to dispense seeds 110. As will be described in detail below, the seed dispensing unit 200 includes a casing 201 which receives the needle handle 204 together with a sheath handle 218 at one end and a stylet handle 228 at the other end, allowing the user to controllly push the handles relative to each other. In some embodiments, the seed dispensing unit 200 is designed so that the needle 104 and applicator 106 can be easily retracted relative to the stylet 108 by the length of a single seed in order to release seeds. In some embodiments, before the needle handle 204 is mounted on the seed distribution unit 200, the proximal handle 210 of the applicator 106 is connected to the needle handle 204, for example, by a swivel luer lock 212.

[0029] In some embodiments, at one end, the seed dispensing unit 200 includes a lip 202 of a sliding needle holder 252 designed to hold a needle handle 204, and at the other end, the seed dispensing unit 200 includes a compartment 218 designed to receive a proximal handle 228 of a stylet 108.

[0030] The seed distribution unit 200 is optionally long enough to receive the needle handle 204, the applicator handle 210, and the stylet handle 228 along with several (e.g., at least two, at least three, at least four, or at least five) free spaces between the applicator handle 210 and the stylet handle 228 for the length of the seeds 110, thereby allowing the needle handle 204 to retract together with the applicator handle 210 and release the seeds.

[0031] The applicant found that releasing the seed 110 by retraction of the needle 104 and / or applicator 106 has advantages over pushing the seed forward by the stylet 108. Using release by retraction, entry into the tumor is made by the distal end of the needle 104 and / or applicator 106, which may be suitable for manipulation by having a sharper end than the seed 110, for example. The precise position of the seed may also be determined before the seed is released, and if necessary, the distal end of the applicator 106 may be repositioned before the seed is released.

[0032] In some embodiments, instead of using retraction, the stylet 108 is pushed forward to push the seed 110 from the needle and / or applicator 106 into the tumor.

[0033] Furthermore, Figure 2 shows a ratchet release button 220 that allows the position of the needle holder 252 (Figure 3) relative to the seed distribution unit 200 to be reset, as will be described later with reference to Figure 8.

[0034] Figure 3 is a schematic diagram of a seed dispensing unit 200 without a needle handle 204 according to an embodiment of the present invention. The seed dispensing unit 200 optionally includes a needle holder 252, also referred to herein as a cradle, having a lip 202 for gripping a needle handle 204 (Figure 2). The needle holder 252 is optionally designed to slide relative to the casing 201. Optionally, the needle holder 252 slides within the casing on a slide frame 260 located on the rear wall of the casing 201. The function of the slide frame 260 will be described later with reference to Figure 7.

[0035] See also Figure 4, a schematic diagram of a cradle needle holder 252 holding a needle handle 204 without a casing 201 according to an embodiment of the present invention. In some embodiments, the cradle needle holder 252 is designed to hold a needle handle 204 of a particular size and shape. In other embodiments, the cradle needle holder 252 can accommodate needle handles of multiple different lengths, for example, by having a wall 254 on the long axis only at the distal end and not the proximal end. Alternatively or in addition, the cradle needle holder 252 can accommodate needle handles of multiple different widths and / or shapes, for example, by the elasticity of the lip 202 and / or the adjustability of the distance between the lip 202 that remains attached to the cradle needle holder 252. Alternatively, or in addition to the above, the casing 201 receptively receives a cradle needle holder 252, and if a non-standard needle handle 204 is used, the needle handle is supplied with a replacement cradle needle holder 252 that properly grips the non-standard needle handle 204.

[0036] Figure 5 is a schematic diagram of an inverted cradle needle holder 252 with a guide 256 used to move the needle holder, according to an embodiment of the present invention. The guide 256 has a guide handle 266 located on the rear outer side of the casing 201 and a guide base 262 connected to the needle holder 252. A T-shaped rod 258 is optionally rotatably connected to both the guide handle 266 and the guide base 262 in such a manner that it connects the guide handle 266 to the guide base 262 while allowing limited rotation of the rod, as will be described in detail below.

[0037] Figure 6 is a schematic diagram of the back side of the casing 201 in addition to the guide handle 266, according to an embodiment of the present invention.

[0038] The guide handle 266 can be moved by an operator, such as a physician, to release the seed 110 (Figure 1). In some embodiments, the casing 201 has a slot 238 on its back side, allowing the rod 258 (Figure 5) to slide.

[0039] Figure 7 is a schematic diagram of a slide frame 260 and a guide 256 according to an embodiment of the present invention. The slide frame 260 has a central slot 272, which corresponds to a slot 238 of the casing 201 (Figure 6), and allows the guide 256 to slide along the casing, thereby moving the needle holder 252 backward and releasing the seed from the distal end of the elongated needle 104.

[0040] In some embodiments, the slide frame 260 further comprises side slots 274 (indicated as 274A, 274B, 274C, and 274D) on both sides of the central slot 272. Each side slot 274 optionally has the length of one seed. The side slots 274 are alternately distributed along the length of the central slot 272 with a slight overlap of about the width of the T-shaped rod 258. As shown in the figure, the side slots 274 are formed only partially in the slide frame 260. In other embodiments, the side slots 274 are formed across the entire thickness of the slide frame 260. Instead of the side slots 274 having the length of one seed, one or more slots, and possibly all slots, have multiple seed lengths, for example, the length of two seeds. In one embodiment, the first side slot 274A has twice the length to release two seeds, and the remaining slots are designed to release one seed each. Alternatively, some or all of the slots 274 may have a length shorter than the length of the seed 110 and be retracted by the length of multiple (e.g., two or three) slots to release the seed needle holder 252.

[0041] Guide 256 is designed such that the T-shaped head of the T-shaped rod 258 does not fit into the central slot 272, but rather one end of the T-shaped head must be in one of the side slots 274. Therefore, in order to slide along the slide frame 260, the end of the T-shaped rod 258 must be located within the slidable side slots 274. First, the end of the T-shaped rod 258 is positioned in side slot 274A. In this position, guide 256 can slide the length of a single seed 110 and thus release the seed. Subsequently, guide handle 266 is optionally pushed in a direction perpendicular to the sliding direction so that the end of the T-shaped rod 258 enters side slot 274B. In this state, guide 256 can slide the length of another seed 110. Then, guide handle 266 is pushed in the opposite direction to its previous push, perpendicular to the sliding direction, so that the end of the T-shaped rod 258 enters side slot 274C. This process can be continued by releasing any number of seeds 110 from within the applicator 106.

[0042] Although the above embodiment describes a specific mechanism for limiting the sliding of the needle holder 252, other suitable mechanisms that slide in stages according to the length of the seed 110, such as a ball plunger, may be used, as will be described later with reference to Figures 10A to 12B.

[0043] Figure 8A is a schematic diagram of a ratchet mechanism 280 inside a casing 201 according to an embodiment of the present invention.

[0044] Figure 8B is a schematic diagram of the interaction between the ratchet mechanism 280 and the needle holder 252 according to an embodiment of the present invention.

[0045] Optionally, a ratchet mechanism 280 restricts the movement of the cradle needle holder 252. Optionally, the needle holder 252 has a hole 282 along its length, and the ratchet mechanism 280 includes a member 284 having a bulge head 285 configured to fit into the hole 282. In some embodiments, a spring biases the bulge head 285 against the back of the cradle needle holder 252 so that when the bulge head 285 is over the hole 282, the bulge head 285 fits into the hole and prevents or restricts the movement of the needle holder 252. To release the bulge head 285, the user presses a ratchet release button 220. The hole 282 is optionally formed at a location corresponding to the end of a side slot 274 so that once the needle holder 252 has moved by the seed length, the needle holder 252 cannot move backward unless the user presses the button 220. The user moves the guide 256 laterally in a manner that allows for further movement to release another seed, while preventing it from moving backward due to the current side slot 274. The user then presses button 220 to remove the bulge head 285 from the hole 282 in which it was positioned, allowing it to move further.

[0046] In some embodiments, the fitting of the bulging head 285 into the hole 282 prevents movement both forward and backward, and movement is only possible by pressing the button 220. Alternatively, the fitting of the bulging head 285 into the hole 282 prevents movement backward, but forward movement is permitted by a hole 282 having a forward inclination that allows the bulging head 285 to retract as it moves forward, for example.

[0047] Figure 9 is a flowchart of the operations performed using the system 100 to implant a radiotherapy seed 110 into a patient's tumor, according to an embodiment of the present invention.

[0048] The method shown in Figure 9 optionally begins with the insertion of an endoscope 102 into the patient (302). In some embodiments, a radial ultrasound device is also inserted into the patient to locate the tumor and direct the distal end of the bronchoscope 102 towards the tumor (304). Alternatively or in addition to this, any other method, such as fluoroscopy, may be used to direct the endoscope 102 towards the tumor (306).

[0049] In some embodiments, the needle 104 is inserted into the endoscope 102 before the applicator 106 is inserted into the needle 104. In these embodiments, the needle 104 is inserted into the proximal end of the endoscope 102 and guided through the endoscope to its distal end (310). Optionally, the needle 104 is inserted into the proximal end of the endoscope 102 from the seed distribution unit 200. After the position of the needle 104 is confirmed (312), the applicator 106 is inserted into the proximal end of the needle outside the patient and guided to the tip of the needle 104. The needle then punctures the tissue (330), and the applicator 106, under the control of a user operating the seed distribution unit 200, inserts the seed into the tumor.

[0050] In another embodiment, the needle 104 is inserted into the patient with the applicator 106 pre-attached (324). The needle 104 is attached to the seed distribution unit 200 with the applicator 106 already inside (328), and the needle and applicator together are guided through the endoscope 102 to the tumor (320). The position of the needle 104 relative to the tumor is confirmed (322), and then the needle punctures the tissue (330), and the seed is inserted into the tumor by pushing the stylet 108 out of the seed distribution unit 200.

[0051] Note that the operations in Figure 9 do not necessarily have to be performed in the order shown and / or described, and may be performed in other orders, and / or one or more operations may be performed simultaneously. For example, in some embodiments, the applicator 106 is inserted into the needle 104 only after the needle has punctured the tumor. Imaging to confirm the position of the needle and applicator may be performed optionally and continuously whenever deemed necessary.

[0052] According to the above embodiment, the seed 110 is delivered to the tumor through four channels. 1) External endoscope 102 2) Needle sheath 118 3) Needle 104 4) Applicator 106

[0053] The seed 110 can be delivered through only two channels (e.g., an endoscope or a needle), but the use of an additional channel (e.g., an applicator 106) provides further flexibility to the delivery process. The applicator 106 provides special protection to the seed 110 to prevent it from rubbing against the inner wall of the needle 104, thereby preventing the radioactive nuclide of the seed 110 from being rubbed off by friction.

[0054] Figure 10A is a schematic diagram of an applicator kit 400 according to an embodiment of the present invention.

[0055] Figure 10B is a schematic diagram of the proximal end of the applicator kit 400 with the first fixing element 410 (Figure 10A) removed, according to an embodiment of the present invention.

[0056] The applicator kit 400 includes an applicator 106 loaded with one or more radioactive seeds (Figure 1) near its distal end, and an applicator handle 210 with a swivel Luer lock 212 for connection to a needle handle 204 at its proximal end. The applicator kit 400 further includes a stylet 108 within the applicator 106, which has a stylet handle 420 attached to a stylet carrier 428. Optionally, the stylet carrier has a ball plunger 402 at its bottom for locking the stylet in a desired position within a casing 454, as described later. In addition, the kit 400 includes a first fixing element 410 and a second fixing element 412. As described above, the applicator 106 is designed to be delivered together with the elongated needle 104 (Figure 1). The elongated needle 104 may be supplied with the applicator kit 400 or may be supplied separately.

[0057] Figure 11A is a schematic top view of a seed distribution unit 450 according to an embodiment of the present invention.

[0058] Figure 11B is a schematic side view of the seed dispensing unit 450 of Figure 11A, with the needle handle 204 and sheath handle 218 mounted inside. The seed dispensing unit 450 has a casing 454 designed to receive the sheath handle 218 at one end and the stylet carrier 428 (Figure 10A) at the other end. Unlike the seed dispensing unit 200, which receives the stylet handle 228 (Figure 2) in a fixed position, the casing 454 is designed so that the stylet carrier 428 can slide within the casing. The seed dispensing unit 450 further includes a slider 452 designed to receive the needle handle 204 and slide together with it along the casing 454. A slide gripper 456 is used by a physician or other medical professional to slide the slider 452. In some embodiments, the casing 454 has one or more ball plungers 460 on its side wall, and the slider 452 has one or more corresponding notches designed to stop sliding at a predetermined distance, for example, the size of a single seed. A notch 458 is formed at the bottom of the casing 454, into which a ball plunger 402 fits to lock the stylet carrier 428, as will be described later.

[0059] Figures 12A and 12B are a side view and a top view, respectively, of a casing 454 in which a stylet carrier 428 is installed, according to an embodiment of the present invention.

[0060] During operation, according to some embodiments, the applicator 106 is mounted within the elongated needle 104, and the applicator handle 210 is mounted within the needle handle 204. The sheath handle 218 is positioned on one side of the casing 454, the needle handle 204 is mounted within the slider 452, and the stylet carrier 428 slides on the other side of the casing 454. In this configuration, with the first and second fixing elements 410 and 412 positioned between the applicator handle 210 and the stylet handle 420, the distal tip of the elongated needle 104 is brought close to the tumor in which the seed 110 is to be implanted. Typically, while delivering the tip of the elongated needle 104 to the tumor, its sharp end is retracted into the sheath 118 so that a gap exists between the sheath handle 218 and the needle handle 204.

[0061] In preparation for implanting the seed 110, the first fixation element 410 is removed from the casing 454. To push the needle 104 into the tumor, the slide gripper 456 slides distally together with the slider 452, thereby moving the needle handle 204, the applicator handle 210, and the stylet carrier 428 toward the sheath handle 218 together with the stylet handle 420. After a penetration distance suitable for a predetermined number of seeds, the ball plunger 402 at the bottom of the stylet carrier 428 locks into the notch 458, preventing the stylet carrier 428 from moving. To release the seeds, the slide gripper 456 slides proximal, thereby pulling the needle 104 and applicator 106 distally, but the stylet 108 does not move because the stylet carrier 428 is locked in place. Therefore, the stylet 108 prevents the seed from retracting with the needle 104, and the seed remains in the tumor.

[0062] Optionally, when the slide gripper 456 is retracted, after the length of each seed has been retracted, the sidewall ball plunger 460 engages with the corresponding notch, indicating to the operator that the seed has been released. After a predetermined number of seeds have been released, the second fixing element 412 may be removed so that the stylet handle 420 can slide distally on the stylet carrier 428 to push further seeds distally into the applicator 106. Next, after positioning the distal end of the sheath 118 appropriately relative to the tumor (the same tumor or a different tumor), the needle 104 is inserted into the tumor and the needle is retracted, repeating the process to implant further seeds.

[0063] In some embodiments, a predetermined number of seeds that can be embedded after the removal of the first fixing element 410 and the second fixing element 412 is 2. However, in other embodiments, the predetermined number of seeds is greater than 2, for example, 3 or 4. Alternatively, the predetermined number of seeds is 1. In the above description, the applicator kit 400 has only two fixing elements 410 and 412, but in other embodiments, the applicator kit has additional fixing elements so that more seeds can be embedded using the applicator kit.

[0064] The endoscope 102 may be any suitable type of endoscope, including bronchoscopes, anoscopes, arthroscopes, colonoscopes, vaginaloscopes, cystoscopes, esophagoscopes, gastroscopy, laparoscopes, laryngoscopy, neuroendoscopes, rectoscopes, sigmoidoscopy, or thoracoscopy. Although the above description relates particularly to endoscopes, in some embodiments of the present invention, the needle 104 and applicator 106 carrying one or more seeds 110 are inserted into the patient through other types of medical probes, which may or may not include observation devices. In yet another embodiment, the needle 104 is inserted directly into the patient without the use of a primary endoscope or medical probe.

[0065] knot It should be understood that the methods and apparatus described above include apparatus for performing the methods and methods for using the apparatus. Features and / or steps described in relation to one embodiment may be used in conjunction with other embodiments, and it should be understood that not all embodiments of the present invention have all features and / or steps shown in a particular figure or described in relation to one particular embodiment. Tasks may not necessarily be performed in the exact order described.

[0066] Some of the embodiments described above may include structures, functions, or details of structures and functions that are not essential to the present invention and are described as illustrative. The structures and functions described herein are replaceable by equivalents that perform the same function, even if the structure or function differs, as is known in the art. The embodiments described above are given as examples, and the present invention is not limited to those specifically shown and described above. Rather, the scope of the present invention includes both combinations and partial combinations of the various features described above, as well as variations and modifications thereof that are not disclosed in the prior art and that a person skilled in the art would conceive of from reading the above description. Accordingly, the scope of the present invention is limited only by the elements and limitations used in the claims, and the terms “comprise,” “include,” “have,” and their inflections, when used in the claims, mean “include, but not necessarily limited.” [Explanation of Symbols]

[0067] 100 Systems 102 Endoscope 104 needles 106 Applicators 108 Stylet 110 Radiation Therapy Seeds 200 seed distribution units

Claims

1. An applicator for delivering radiotherapy seeds to a patient's tumor through a flexible, elongated needle, wherein the flexible, elongated needle comprises a needle handle and a needle tube having a predetermined length for insertion into the patient. The aforementioned applicator is An elongated applicator tube designed to allow the passage of the aforementioned flexible, elongated needle, comprising the elongated applicator tube forming an internal channel for receiving one or more radiotherapy seeds, While the flexible, elongated needle is inserted into the patient, an elongated applicator can be operated separately from the flexible, elongated needle, and an applicator handle is configured to be attached to the needle handle, The stylet inside the elongated applicator tube, It has, The elongated applicator tube is longer than the flexible, elongated needle.

2. The applicator according to claim 1, wherein the elongated applicator tube can pass through the internal channel of the elongated needle when the elongated needle is inside the patient.

3. The applicator according to claim 1, wherein the elongated applicator tube has a length such that when the applicator handle is attached to the needle handle, the distal end of the elongated applicator tube is close to the distal end of the elongated needle.

4. The applicator according to claim 1, wherein the elongated applicator tube has a length of at least 20 centimeters.

5. The applicator according to any one of claims 1 to 4, further comprising a seed distribution unit configured to be connected to the applicator handle and the stylet handle of the stylet, wherein the seed distribution unit has a guide handle for moving the applicator handle relative to the stylet handle so that the stylet pushes seeds out from the distal end of the elongated applicator tube.

6. The aforementioned seed distribution unit is A casing configured to receive the aforementioned stylet handle, A sliding member within the casing, configured to be coupled to the applicator handle and to slide relative to the casing, The applicator according to claim 5, having the following:

7. The seed distribution unit limits the range of movement of the guide handle in one stroke, as described in claim 6.

8. The applicator according to claim 7, wherein the seed distribution unit is configured to limit the range of movement of the guide handle in one stroke to the length of a single seed.

9. The applicator according to claim 8, wherein the seed distribution unit is configured to require lateral movement of the guide handle to enable further movement of the guide handle to achieve relative movement of the applicator handle with respect to the stylet handle after the movement of the length of the single seed.

10. The applicator according to claim 5, wherein the movement of the guide handle of the seed distribution unit is configured to retract the applicator handle while the stylet handle is held in a predetermined position.

11. The applicator according to claim 10, wherein the elongated applicator tube has a length of at least 50 centimeters.

12. A system for delivering radiation therapy seeds to tumors, An endoscope that forms a long, narrow channel, A long, thin needle that passes through the long, thin channel of the endoscope, and includes a proximal handle that allows the long, thin needle to be operated separately from the endoscope, An elongated applicator comprising an elongated needle passing through and constituting an internal channel for receiving one or more radiotherapy seeds, the elongated applicator including an applicator handle that allows the elongated applicator to be operated separately from the elongated needle, The stylet inside the aforementioned elongated applicator, A system that has

13. The system according to claim 12, further comprising a seed dispensing unit, wherein the seed dispensing unit is configured to receive the handle of the needle within one end of the seed dispensing unit and the handle of the stylet within the other end of the seed dispensing unit.

14. The system according to claim 13, wherein the seed distribution unit includes a needle handle connector configured to connect to the handle of the needle, and a proximal compartment for receiving the handle of the stylet.

15. The system according to claim 14, wherein the seed distribution unit includes a guide handle that pushes the needle handle connection toward the proximal compartment by a fixed length sufficient to distribute a single seed from the applicator.

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