Radiotherapy applicator and system for delivery of radiotherapy seeds

Abstract

This invention discloses an applicator for delivering radiotherapy seeds to a tumor in a patient via an elongated needle (104). The elongated needle includes a needle handle (204) and a tube of a given length for insertion into the patient. The applicator includes: an elongated applicator tube (106) designed to pass through the elongated needle, wherein the elongated applicator tube defines an internal channel for receiving one or more radiotherapy seeds (110); an applicator handle (210) configured to attach 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] This invention relates generally to radiotherapy, and more particularly to a method for implanting a radiotherapy source into a tumor in an internal organ. Prior Technology

[0002] Avapor emission systems are a powerful tool for radiotherapy of certain types of tumors, including malignant tumors. Proper delivery of the seeds embedded in the avapor emitter is crucial for treatment success. Delivery should place the seeds accurately within the tumor without prematurely exposing the patient and other tissues to radioactive materials and other unhealthy substances.

[0003] One type of ava radiation therapy source is a diffuse ava emitter radiation therapy (DaRT) source containing radium-223 or radium-224 atoms, which has a half-life that is neither too long nor too short for therapeutic purposes.

[0004] Kelson’s U.S. Patent 8,834,837 describes a method for DaRT processing.

[0005] PCT publication WO2015 / 136192, entitled "Brachytherapy Device and Associated Therapeutic Method," describes a container for delivering a radioactive substance through a needle inserted into a channel of an endoscope.

[0006] Wang’s U.S. Patent 4,532,935 describes a bronchial needle comprising an outer catheter, a needle attached to an inner catheter and located inside the outer catheter, and a perforator passing through the needle. Summary of the Invention

[0007] According to embodiments of the present invention, this document provides a device for delivering radiotherapy seeds to a tumor in a patient via a long, thin needle, wherein the long, thin needle includes a needle handle and a needle tube having a given length for insertion into the patient's body, comprising: A slender therapeutic device tube, designed to pass through the slender needle, wherein the slender therapeutic device tube defines an internal channel for receiving one or more radiotherapy seeds; A treatment device handle, configured to attach to the needle handle; and A tube, inside the slender therapeutic device tube, The slender therapeutic tube is longer than the slender needle.

[0008] Depending on the situation, the elongated tube of the device may have a flexibility unsuitable for insertion into a patient's body, but when the elongated needle is in the patient's body, the elongated tube can pass through an internal channel of the elongated needle. Depending on the situation, the elongated tube of the device may have a length such that when the device handle is attached to the needle handle, a distal end of the elongated tube is very close to a distal end of the elongated needle. Depending on the situation, the elongated tube of the device may have a length of at least 20 cm. Depending on the situation, the device may further include a seed dispensing unit configured to grip the device handle and a handle of the swivel, which allows the device handle to move relative to the swivel handle such that the swivel dispenses a seed to the distal end of the elongated tube. Depending on the situation, the seed dispensing unit may include: a housing configured to grip the swivel handle; and a slidable clamp configured to couple to the device handle and slide relative to the housing.

[0009] Depending on the application, the seed dispensing unit includes a guide handle that moves the device handle relative to the sprue handle as the user moves it along one axis of the elongated device tube. Depending on the application, the seed dispensing unit is configured to limit the movement of the guide handle along the axis of the elongated device tube in a single stroke to the length of a single seed. Depending on the application, the seed dispensing unit is configured to require lateral movement of the guide handle to allow further movement along the axis of the elongated device tube after moving the length of a single seed. Depending on the application, the seed dispensing unit is configured to retract the device handle when the sprue handle is secured in place. Depending on the application, the elongated device tube has a length of at least 50 centimeters.

[0010] According to an embodiment of the present invention, a seed allocation unit is further provided, comprising: A device handle holder configured to grip at its distal end one handle of an elongated device containing a plurality of radiotherapy seeds; A handle gripper for a perforated strip, configured to grip one handle of a perforated strip in the elongated therapeutic device; and A housing configured to allow movement of the device handle holder relative to the sprue handle gripper, such that the sprue pushes a seed out of the distal end of the elongated device, wherein the housing is configured to limit the uninterrupted movement of the device handle holder relative to the sprue handle gripper to the length of a single seed, such that further movement is only permitted after an adjustment operation by a human user.

[0011] Depending on the application, the device handle holder includes a guide handle used by the user to move the device handle holder relative to the scalpel handle gripper in a first direction, wherein the housing needs to move in a second direction different from the first direction, so as to move beyond the length of a single seed in the first direction. Depending on the application, the second direction is perpendicular to the first direction. Depending on the application, the device handle holder includes a ratchet that prevents the device handle holder from moving backward after moving the length of a single seed unless a ratchet release button is pressed. Depending on the application, the housing includes one or more ball plungers that limit the uninterrupted movement of the device handle holder relative to the scalpel handle gripper to the length of a single seed.

[0012] According to an embodiment of the present invention, a system for delivering radiotherapy seeds to a tumor is further provided, comprising: an endoscope defining an elongated channel; an elongated needle passing through the elongated channel of the endoscope; an elongated device passing through the elongated needle and defining an internal channel for receiving one or more radiotherapy seeds; and a tube within the elongated device.

[0013] Depending on the application, the system includes a seed dispensing unit configured to receive a handle of the needle at one end and a handle of the sty at a pair of opposite ends. Depending on the application, the seed dispensing unit includes a needle handle holder configured to secure the needle handle and the handle receiving the sty of the sty to a proximal compartment. Depending on the application, the seed dispensing unit is configured to advance the needle handle holder toward the proximal compartment by a fixed length sufficient to dispense a single seed from the device.

[0014] According to an embodiment of the present invention, a method for delivering radiotherapy seeds to one of the internal organs of a patient is further provided, comprising: A long, slender device is provided, the length of which is sufficient to extend from the outside of the patient to the internal organ, wherein the long, slender device includes one or more radiotherapy seeds at its distal end and a tube passing through the long, slender device to one or more radiotherapy seeds from its proximal end; Insert the elongated therapeutic device into a long, thin needle; The thin needle pierces a hole in the internal organ; and At least one seed is dispensed into the patient's body by retracting the slender needle and the slender therapeutic device relative to the scalpel.

[0015] As appropriate, the elongated needle is inserted into the elongated needle when it extends from the outside of the patient to the internal organ. As appropriate, the elongated needle is inserted into the elongated needle when it is completely outside the patient. As appropriate, the method includes guiding the needle to the vicinity of one of the organs through an endoscope. As appropriate, the method includes connecting one handle of the needle to one handle of the device before dispensing the at least one seed. Simple Explanation of the Diagram

[0016] Figure 1 is a partial cross-section of a system for delivering radiotherapy seeds according to an embodiment of the present invention;

[0017] Figure 2 is a schematic diagram of the proximal end of a needle in a seed distribution unit according to an embodiment of the present invention;

[0018] Figure 3 is a schematic diagram of a seed dispensing unit without a needle handle according to an embodiment of the present invention, as shown in Figure 2.

[0019] Figure 4 is a schematic diagram of a support needle holder for fixing a needle handle according to an embodiment of the present invention;

[0020] Figure 5 is a schematic diagram of an inverted needle holder with a guide for moving a needle holder according to an embodiment of the present invention;

[0021] Figure 6 is a schematic diagram of the back of the outer casing of a seed distribution unit according to an embodiment of the present invention and a guide handle;

[0022] Figure 7 is a schematic diagram of a sliding frame and a corresponding guide according to an embodiment of the present invention;

[0023] Figures 8A and 8B are schematic diagrams of a ratchet mechanism according to one embodiment of the present invention;

[0024] Figure 9 is a flowchart of one of the actions performed when a radiotherapy seed is implanted in a tumor of a patient according to an embodiment of the present invention;

[0025] Figure 10A is a schematic diagram of a therapeutic device kit according to an embodiment of the present invention;

[0026] Figure 10B is a schematic diagram of the proximal end of a therapeutic device kit of Figure 10A with a first fixation element removed, according to an embodiment of the present invention;

[0027] Figure 11A is a schematic top view of a seed allocation unit according to one embodiment of the present invention;

[0028] Figure 11B is a schematic side view of one of the seed dispensing units of Figure 11A, in which a needle handle and a sheath handle are installed; and

[0029] Figures 12A and 12B are respectively a side view and a top view of the seed distribution unit of Figure 11A, which has a through-strip carrier installed therein, according to one embodiment of the present invention. Implementation

[0030] Cross-reference to related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 159,499, filed March 11, 2021, the disclosure of which is incorporated herein by reference.

[0031] One embodiment of the present invention relates to the delivery of radiotherapy seeds to an internal organ of a patient within three tubes, one within another, each tube being operable independently. Delivery of radiotherapy seeds within three tubes increases delivery flexibility. In some embodiments, the outer tube is an endoscope, the middle tube is a slender needle, and the inner tube is a loading device carrying the seed. In addition to the endoscope, the use of the slender needle allows access to the vicinity of a tumor using the properties of the endoscope (such as rigidity and visibility), while simultaneously utilizing the additional flexibility and smaller diameter of the slender needle to reach the tumor itself. Using a slender loading device separate from the slender needle to carry the seed allows delivery of the seed to the distal end of the slender needle while it is inside the patient, without the seed passing through an internal channel of the slender needle, in a manner that allows the seed to rub against the inner wall of the slender needle. Because some radiotherapy seeds have equally active radioactive particles on their outer surfaces, passing the seed through an internal channel of the slender needle can cause the seed to lose a significant portion of its activity due to friction against the inner wall of the slender needle. Individual insertion of a slender syringe allows for the delivery of additional seeds to the tumor beyond the initial seed loaded with the slender needle. Furthermore, using a slender syringe allows for the delivery of the distal end of the slender needle to the tumor without the seed within, thus allowing for further flexibility of the slender needle if necessary.

[0032] One embodiment of the present invention relates to a system for delivering seeds to an internal organ of a patient. The system comprises two elongated tubes of substantially the same length, one tube inserted into the other. Optionally, each elongated tube has a handle, and the handles are configured to couple with the distal ends of the elongated tubes in a manner very close to each other when the handles are coupled. In some embodiments, the inner tube carries one or more radiotherapy seeds and a guide for ejecting the seeds from the distal end of the device.

[0033] Figure 1 is a partial cross-section of a system 100 for delivering one or more radiotherapy seeds 110 to a location within a patient according to an embodiment of the present invention. The system 100 includes an endoscope 102 adapted for insertion into a patient. An elongated needle 104 having a sharp edge 114 (schematically shown in Figure 1) is inserted through a channel of the endoscope 102, such as in the field of performing biopsies. As shown in Figure 1, the elongated needle 104 may be accompanied by an outer sheath 118, wherein the elongated needle 104 can slide between a delivery state in which the sharp edge 114 is completely within the sheath 118 and an operating state in which the sharp edge 114 is outside the sheath.

[0034] One of the implantation devices 106 carrying seeds 110 passes through a needle 104. A guide strip 108 within the implantation device 106 is used to push the seeds 110 into the patient's body. As shown in the figure, the implantation device 106 carries five seeds 110, each seed having a length between 0.5 cm and 2 cm. Note that the implantation device 106 may carry fewer than five or at least three seeds 110, or more than five or at most ten seeds 110.

[0035] Although the needle 104 is shown inside one of the channels of the endoscope 102, in some cases, the needle 104 may extend beyond the distal end of the endoscope and enter areas that are too narrow or inaccessible to the endoscope 102. Therefore, generally, at least one distal portion of the elongated needle 104 is rigid enough to allow independent manipulation within a patient's body, while being flexible enough to move through twisted and 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 even less than 1 mm (e.g., 0.8 mm), and an inner diameter of less than 1.25 mm, less than 1 mm, less than 0.8 mm, or even less than 0.6 mm (e.g., 0.45 mm). Alternatively or additionally, the elongated needle 104 has a relatively large outer diameter, such as greater than 1 mm, greater than 1.2 mm, or even greater than 1.5 mm.

[0036] For the insertion of 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 accommodate the seed 110, which may have a diameter greater than 0.3 mm (e.g., 0.37 mm). The walls of the applicator 106 may have a thickness less than 0.2 mm, less than 0.15 mm, or even less than 0.1 mm. Because the applicator 106 is intended to pass through the internal channel of the needle 104, in some embodiments, the applicator 106 is so flexible that it is not suitable for passing through a patient's body by itself. In addition, the applicator 106 may have a high degree of flexibility such that when located within the needle 104, the combined flexibility of the needle 104 and the applicator 106 still allows it to move within the patient's body. Alternatively or additionally, when complex manipulations are required, the applicator 106 is removed from the needle 104 and returned after the needle is correctly positioned. In some embodiments, the device 106 includes a braided or non-braided composite polyimide tube. The device 106 can also be removed from the needle 104 to be refilled at its distal end with the seed 110, and then reinserted into the needle 104 after refilling with the seed. The elongated tube of the device 106 is configured to be sufficiently rigid to allow for removal and reinsertion.

[0037] In some embodiments, the applicator 106 has a length that is the same as that of the elongated needle 104 (e.g., with a difference of no more than 20 mm or no more than 10 mm), such that when the applicator 106 is inserted into the internal channel of the needle 104 and its handle is connected, the distal end of the applicator 106 coincides with the distal end of the needle 104 (within 10 mm, or even within 5 mm). In some embodiments, the applicator 106 is longer than the handle of the needle 104 by within 5 mm.

[0038] In other embodiments, the device 106 is longer than the slender needle 104 by such a degree that, when its handle is attached, the device 106 extends at least 2 cm, at least 5 cm, or even at least 8 cm beyond the end of the needle 104. Where appropriate, the distal end of the device 106 includes a rigid material, such as nitinol, which allows a sharp needle to puncture a tumor. Inserting the device 106 itself into the tumor has the advantage of forming an entry hole of a relatively small diameter. In some embodiments, the distal end of the device 106 is pre-shaped at a specific angle to achieve a specific position and / or orientation that is more difficult to approach with a needle.

[0039] The slender tubes of the needle 104 and the therapeutic device 106 have a length of at least 20 cm, at least 50 cm, at least 80 cm, at least 100 cm, at least 120 cm, or even at least 150 cm. The tube 108 is generally slightly longer than the therapeutic device 106, so that it can push all the seeds 110 out of the distal end of the therapeutic device.

[0040] Figure 2 is a schematic diagram of a proximal end of a needle 104 in a seed dispensing unit 200 according to an embodiment of the present invention. The seed dispensing unit 200 is designed to allow a human user to controllably move the needle 104 and the applicator 106 relative to a swivel 108 to dispense seeds 110. As explained in detail below, the seed dispensing unit 200 includes a housing 201 that receives a needle handle 204 and a sheath handle 218 at a first end and a swivel handle 228 at a pair of opposite ends, allowing the user to controllably push the handles relative to each other. In some embodiments, the seed dispensing unit 200 is designed to easily retract the needle 104 and the applicator 106 relative to the swivel 108 to the length of a single seed to release the seed. In some embodiments, before the needle handle 204 is loaded into the seed dispensing unit 200, a proximal handle of the applicator 106 (e.g., applicator handle 210) (e.g., by means of a rotary Luer lock 212) is connected to the needle handle 204.

[0041] In some embodiments, at one end, the seed dispensing unit 200 includes a leading edge 202 of a slidable needle holder 252 designed to hold a needle handle 204, and at a pair of opposite ends, the seed dispensing unit 200 includes a compartment 218 designed to receive a sprue handle 228 located at the proximal end of a sprue 108.

[0042] The seed distribution unit 200 is long enough, as appropriate, to receive the needle handle 204, the device handle 210, and the cleaning rod handle 228, and an empty area between the device handle 210 and the cleaning rod handle 228, the length of which is several (e.g., at least 2, at least 3, at least 4, or even at least 5) seeds 110, such that the needle handle 204 and the device handle 210 can retract in one of the ways of releasing seeds.

[0043] The applicant found that releasing the seed 110 via the retractable needle 104 and / or the loading device 106 is advantageous compared to pushing the seed forward via the scalpel 108. Using retractable release, with the needle 104 and / or the loading device 106 inserted distally into the tumor, is more manipulable than the seed 110, for example, by having a sharp end. Furthermore, the precise location of the seed can be determined before release, and the distal end of the loading device 106 can be repositioned if necessary before release.

[0044] However, note that in some embodiments, instead of retraction, the tube 108 is pushed forward to push the seed 110 out of the needle and / or the device 106 into the tumor.

[0045] Figure 2 also shows a ratchet release button 220, which allows the needle holder 252 (Figure 3) to be reset relative to the seed distribution unit 200, as discussed below with reference to Figure 8.

[0046] Figure 3 is a schematic diagram of a seed dispensing unit 200 without a needle handle 204 according to one embodiment of the present invention. The seed dispensing unit 200 may include a needle holder 252, also referred to herein as a support, having a leading edge 202 intended to grip the needle handle 204 (Figure 2). The needle holder 252 may be designed to slide relative to the housing 201. The needle holder 252 may slide on a sliding frame 260 located on the rear wall of the housing 201. The function of the sliding frame 260 is discussed below with reference to Figure 7.

[0047] Referring also to FIG4, FIG4 is a schematic diagram of a stent needle holder 252 without a housing 201 for securing a needle handle 204 according to one embodiment of the present invention. In some embodiments, the stent needle holder 252 is designed to secure a needle handle 204 of a specific size and shape. In other embodiments, the stent needle holder 252 may, for example, receive a plurality of needle handles of different lengths by having a wall 254 on its long axis only at its distal end and not its proximal end. Alternatively or additionally, the stent needle holder 252 may receive a plurality of needle handles of different widths and / or shapes, for example, due to the elasticity of the leading edge 202 and / or the adjustability of the distance between the leading edges 202 mounted on the stent needle holder 252. Alternatively or additionally, the housing 201 may alternatively receive the stent needle holder 252, and when an irregular needle handle 204 is used, the needle handle is equipped with a replacement stent needle holder 252 that properly grips the irregular needle handle 204.

[0048] Figure 5 is an inverted schematic diagram of a support needle holder 252 having a guide 256 for moving a needle holder according to an embodiment of the present invention. The guide 256 includes a guide handle 266 located on the outer rear side of a housing 201 and a guide base 262 connected to the needle holder 252. A T-shaped rod 258 is rotatably connected to both the guide handle 266 and the guide base 262 as needed, connecting the guide handle 266 to the guide base 262 in a manner that allows limited rotation of the rod, as discussed in detail below.

[0049] Figure 6 is a schematic diagram of the back of the housing 201 and the guide handle 266 according to one embodiment of the present invention.

[0050] The guide handle 266 can be moved by an operator (e.g., a physician) to release the seed 110 (FIG. 1). In some embodiments, the housing 201 has a groove 238 on its back to allow the rod 258 to slide (FIG. 5).

[0051] Figure 7 is a schematic diagram of a sliding frame 260 and a guide 256 according to one embodiment of the present invention. The sliding frame 260 includes a central groove 272 corresponding to a groove 238 in the housing 201 (Figure 6) and allows the guide 256 to slide along the housing, thereby moving the needle holder 252 backward and releasing the seed from the distal end of one of the slender needles 104.

[0052] In some embodiments, the sliding frame 260 further defines side slots 274 (labeled 274A, 274B, 274C, 274D) on both sides of the central slot 272. Each side slot 274 has one seed length, depending on the situation. The side slots 274 are distributed alternately along the length of the central slot 272, slightly overlapping by about the width of the T-shaped bar 258. As shown, the side slots 274 are only partially etched in the sliding frame 260. In other embodiments, the side slots 274 extend through the entire thickness of the sliding frame 260. Alternatively, in addition to the side slots 274 having one seed length, one or more slots (possibly even all slots) have multiple seed lengths, such as two seeds. In one embodiment, the first side slot 274A has a double length for releasing one of two seeds, and the remaining slots are designed to release a single seed. Alternatively, some or all of the slots 274 have a length less than that of the seed 110, and in order to release the seed, the needle holder 252 is retracted by the length of several (e.g., two or three) slots.

[0053] The guide 256 is designed such that the T-shaped head of the T-shaped rod 258 does not fit into the central slot 272, and requires one edge of the T-shaped head to be in a side slot 274. Therefore, in order to slide along the sliding frame 260, one edge of the T-shaped rod 258 needs to be located in a side slot 274 that allows sliding. First, one edge of the T-shaped rod 258 is located in side slot 274A. In this position, the guide 256 can slide for the length of a single seed 110, thus releasing one seed. Subsequently, the guide handle 266 is pushed perpendicularly to the sliding direction, causing one edge of the T-shaped rod 258 to enter side slot 274B. In this state, the guide 256 can slide for the length of another seed 110. Next, the guide handle 266 is pushed perpendicularly to the sliding direction in a direction opposite to its previous push, causing one edge of the T-shaped rod 258 to enter side slot 274C. This process can continue to release any number of seeds 110 within the self-loading device 106.

[0054] Note that although the above embodiments describe a particular mechanism for limiting the sliding of the needle holder 252, any other suitable mechanism for sliding in steps along the length of the seed 110, such as a ball plunger, may be used, as discussed below with reference to Figures 10A to 12B.

[0055] Figure 8A is a schematic diagram of a ratchet mechanism 280 inside the housing 201 according to one embodiment of the present invention.

[0056] Figure 8B is a schematic diagram of an interaction between a ratchet mechanism 280 and a needle holder 252 according to one embodiment of the present invention.

[0057] Depending on the situation, the ratchet mechanism 280 restricts the movement of the support needle holder 252. Depending on the situation, the needle holder 252 defines a hole 282 along its length, and the ratchet mechanism 280 includes a member 284 having a protrusion 285 configured to engage with the hole 282. In some embodiments, a spring presses the protrusion 285 against the back of the support needle holder 252 such that when the protrusion 285 is above the hole 282, the protrusion 285 engages with the hole and prevents or restricts movement of the needle holder 252. To release the protrusion 285, a user can press a ratchet release button 220. The hole 282 may define a point corresponding to the end of the side groove 274 such that once the needle holder 252 has moved to a certain length, the needle holder 252 cannot move backward without the user pressing the button 220. To release another sub, the user moves the guide 256 laterally in a manner that allows further movement while preventing rearward movement from a current side slot 274. The user then presses button 220 to remove the protruding head 285 from its hole 282 and allow further movement.

[0058] In some embodiments, the protruding head 285 is mounted in a hole 282 to prevent both forward and backward movement, and movement is permitted only by pressing button 220. Alternatively, the protruding head 285 is mounted in a hole 282 to prevent backward movement, but forward movement is permitted, for example, by means of a hole 282 having a forward slope, allowing the protruding head 285 to move forward.

[0059] Figure 9 is a flowchart of one of the actions performed using system 100 to implant radiotherapy seed 110 into a tumor of a patient according to one embodiment of the present invention.

[0060] The method in Figure 9 begins, as appropriate, by inserting the endoscope 102 into the patient (302). In some embodiments, a circular ultrasound probe is also inserted (304) into the patient to locate the tumor and guide one distal end of the bronchoscope 102 to the tumor. Alternatively or additionally, any other method may be used to guide the endoscope 102 to the tumor, such as fluoroscopy (306).

[0061] In some embodiments, the needle 104 is inserted into the endoscope 102 before the device 106 is inserted. 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). Depending on the situation, the needle 104 is inserted from the seed dispensing unit 200 into the proximal end of the endoscope 102. After verifying the position of the needle 104 (312), the device 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 (330) the tissue, and under the control of a user operating the seed dispensing unit 200, the device 106 inserts a seed into the tumor.

[0062] In other embodiments, a needle 104 is inserted into the patient, with a loading device 106 pre-loaded therein (324). The needle 104 is mounted (328) in a seed dispensing unit 200, in which the loading device 106 is already present, and the needle and loading device are guided (320) through an endoscope 102 to the tumor. The position of the needle 104 relative to the tumor is verified (322), and then the needle punctures (330) the tissue, and a seed is inserted into the tumor by pushing a tube 108 from the seed dispensing unit 200.

[0063] Note that the actions in Figure 9 may not be performed in the sequence shown and / or described, and the actions may be performed in other sequences and / or one or more actions may be performed simultaneously. For example, in some embodiments, the device 106 is inserted into the needle 104 only after the needle has punctured the tumor. Imaging for verifying the position of the needle and device may be performed at any time deemed necessary (continuously as appropriate).

[0064] According to the above embodiments, the seed 110 is delivered to the tumor through four channels: 1) External endoscope 102 2) Needle sheath 118 3) Needle 104 4) Therapy device 106

[0065] Although the seed 110 can only be delivered in two channels (e.g., endoscope and needle), the use of an additional channel (e.g., device 106) provides greater flexibility in the delivery process. Device 106 provides additional protection for the seed 110 and prevents it from rubbing against the inner wall of the needle 104, so that the radionuclide of the seed 110 is not erased due to friction.

[0066] Figure 10A is a schematic diagram of a therapeutic device kit 400 according to one embodiment of the present invention.

[0067] Figure 10B is a schematic diagram of the proximal end of a therapeutic device kit 400 having a first fixation element 410 (Figure 10A) removed according to one embodiment of the present invention.

[0068] The loading device kit 400 includes: a loading device 106 loaded with one or more radioactive seeds near its distal end (FIG. 1); and a loading device handle 210 having a rotary Luer lock 212 at its proximal end for connection to a needle handle 204. The loading device kit 400 further includes a tube 108 within the loading device 106, having a tube handle 420 mounted on a tube carrier 428. Optionally, the tube carrier includes a ball plunger 402 at its bottom to lock the tube in a desired position within a housing 454, as discussed below. Additionally, the kit 400 includes a first fixing element 410 and a second fixing element 412. As discussed above, the loading device 106 is designed for delivery using an elongated needle 104 (FIG. 1). The elongated needle 104 may be provided with the loading device kit 400 or separately.

[0069] Figure 11A is a schematic top view of a seed allocation unit 450 according to one embodiment of the present invention.

[0070] Figure 11B is a schematic side view of the seed dispensing unit 450 of Figure 11A, in which the needle handle 204 and sheath handle 218 are mounted. The seed dispensing unit 450 includes a housing 454 designed to receive the sheath handle 218 at one end and a cleaning strip carrier 428 (Figure 10A) at the other end. Unlike the seed dispensing unit 200, which receives the cleaning strip handle 228 (Figure 2) in a fixed position, the housing 454 is designed to allow the cleaning strip carrier 428 to slide within the housing. The seed dispensing unit 450 further includes a slider 452 designed to receive the needle handle 204 and slide along the housing 454 with it. A sliding gripper 456 is used by a physician or other medical professional to slide the slider 452. In some embodiments, the housing 454 has one or more ball plungers 460 on its sidewalls, and the slider 452 has corresponding slots designed to stop sliding at a predetermined distance (e.g., the size of a single seed). As discussed below, a notch 458 is defined at the bottom of the housing 454, in which the ball plunger 402 is adapted to lock the sprue carrier 428.

[0071] Figures 12A and 12B are side and top views, respectively, of a housing 454 in which a guide bar carrier 428 is mounted, according to one embodiment of the present invention.

[0072] In operation, according to some embodiments, the device 106 is mounted in a slender needle 104, and the device handle 210 is attached to the needle handle 204. A sheath shank 218 is positioned on one side of the housing 454, the needle handle 204 is mounted in a slide 452, and the tube carrier 428 slides to the other side of the housing 454. In this state, when the first fixation element 410 and the second fixation element 412 are in place between the device handle 210 and the tube handle 420, the distal tip of the slender needle 104 approaches a tumor to which the seed 110 is to be implanted. Generally, during the delivery of the tip of the slender needle 104 to the tumor, its sharp end retracts into the sheath 118, creating a gap between the sheath shank 218 and the needle handle 204.

[0073] In preparation for seed implantation 110, the first fixation element 410 is removed from the housing 454. To push the needle 104 into the tumor, the sliding gripper 456 slides distally together with the slide 452, thus moving the needle handle 204, the loading device handle 210, and the tube carrier 428 together with the tube handle 420 toward the sheath handle 218. After penetrating a predetermined number of seeds to a suitable distance, the ball plunger 402 at the bottom of the tube carrier 428 locks into the slot 458, preventing the tube carrier 428 from moving. To release the seeds, the sliding gripper 456 slides proximally, thus pulling the needle 104 and loading device 106 distally, while the tube 108 does not move because the tube carrier 428 is locked in place. Therefore, the tube 108 does not allow the seeds to retract with the needle 104, and they remain in the tumor.

[0074] Depending on the situation, in the retracting sliding gripper 456, after retracting various seed lengths, a side wall ball plunger 460 is inserted into a corresponding slot, indicating to the operator that a seed has been released. After releasing a predetermined number of seeds, the second fixing element 412 can be removed to allow the tube handle 420 to slide distally on the tube carrier 428, thereby further pushing the seeds within the device 106 distally. Next, after positioning the distal end of the sheath 118 in an appropriate position relative to a tumor (the same tumor or a different tumor), the operation of inserting the needle 104 into the tumor and retracting the needle is repeated to implant more seeds.

[0075] In some embodiments, the predetermined number of seeds that can be implanted after removing each of the first fixation element 410 and the second fixation element 412 is two. However, in other embodiments, the predetermined number of seeds is greater than two, such as three or four. Alternatively, the predetermined number of seeds is one. Although the device kit 400 described above has only two fixation elements 410 and 412, in other embodiments, a device kit has additional fixation elements, allowing for the implantation of more seeds using the device kit.

[0076] Endoscope 102 can be any suitable type of endoscope, including a bronchoscope, anoscope, arthoscope, colonoscope, colposcope, cystoscope, esophagusoscope, gastroscope, laparoscope, laryngoscope, neuroendoscope, rectoscope, sigmoidoscope, or thoracoscope. Although the above description specifically relates to an endoscope, in some embodiments of the invention, a needle 104 carrying one or more seeds 110 and a device 106 is inserted into a patient through other types of medical probes, with or without observation devices. Still in other embodiments, the needle 104 is inserted directly into the patient without the use of a leading endoscope or medical probe. Summarize

[0077] It will be understood that the methods and apparatus described above are to be interpreted as including means for performing methods and methods of using means. It should be understood that features and / or steps described with respect to one embodiment may sometimes be used with other embodiments, and not all embodiments of the invention have all the features and / or steps shown in a particular figure or described with respect to a particular embodiment. Tasks may not be performed in the exact order described.

[0078] Note that some of the embodiments described above may include structural, operational, or structural details that are not essential to the present invention and are described as examples. The structures and operations described herein may be replaced by equivalents that perform the same function, even if the structures or operations differ, as is known in the art. The embodiments described above are cited as examples, and the present invention is not limited to what has been specifically shown and described above. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described above, as well as variations and modifications that would occur to those skilled in the art upon reading the foregoing description and not disclosed in the prior art. Therefore, the scope of the present invention is limited to the elements and limitations used in the claims, wherein the terms "comprising," "including," "having," and their variations, when used in the claims, should mean "including but not necessarily limited to."

[0079] 100: System 102: Endoscopy 104: Fine needle 106: Therapeutic Device 108: Circular 110: Radiotherapy Seeds 114: Sharp edge 118:Sheath 200: Seed Allocation Unit 201: Outer shell 202: The Prelude 204: Needle handle 210: Handle of the therapy device 212: Rotary Luer Lock 218: Sheath handle 220: Button 228: Cleaning rod handle 238: slot 252: Needle holder 254:Wall 256: Guide 258: T-shaped bar 260: Sliding Frame 262: Guiding base 266: Guide Handle 272: Central Slot 274A: Side Groove 274B: Side Groove 274C: Side Groove 274D: Side Groove 280: Ratchet Mechanism 282: Kong 285: Protruding head 302: Insert bronchoscope 102 into the lung airway. 304: Inserting radial ultrasound into the lungs and locating tumor tissue. 306: Fluorescent Perspective Method and Navigation Map Delineation 308: Install needle 104 into seed distribution unit 200 310: Insert needle 104 into bronchoscope 102 and guide needle 104 to the tumor tissue. 312: Navigation verification was performed using a comparison needle 104, fluorescence spectroscopy, and ultrasonic fluorescence spectroscopy maps. 314: Insert the treatment device 106 into the needle 104. 320: Insert needle 104 into bronchoscope 102 and guide needle 104 to the tumor tissue. 322: Navigation verification was performed using a comparison needle 104, fluorescence spectroscopy, and ultrasonic fluorescence spectroscopy maps. 324: Insert the treatment device 106 into the needle 104. 328: Install needle 104 in seed distribution unit 200 330: Tissue aspiration and seed allocation 110 400: Therapy Kit 402: Ball plunger 410: First fixed element 412: Second fixing element 420: Cleaning rod handle 428: Flow carrier 450: Seed Allocation Unit 452: Slider 454: Outer shell 456: Sliding gripper 458: Groove 460: Ball plunger

Claims

1. A seed allocation unit, comprising: An applicator handle holder configured to grasp a handle of an elongate applicator, wherein the elongate applicator includes a plurality of radiotherapy seeds at its distal end; a stylet handle grasper configured to grasp a handle of a stylet within the elongate applicator; a housing allowing the applicator handle holder to move relative to the stylet handle grasper such that the stylet ejects a seed from the distal end of the elongate applicator; and a slidable holder configured to couple to the applicator handle and slide relative to the housing and the stylet handle grasper such that sliding the slidable holder ejects a seed from the distal end of the elongate applicator.

2. The seed allocation unit as requested in item 1, wherein the housing is configured to grip the spool handle gripper.

3. The seed distribution unit as requested in item 1 or 2, wherein the sliding system of the sliding clamp of the device handle that moves relative to the swivel handle is limited to a given length in a single stroke.

4. The seed distribution unit as claimed in claim 3, wherein the sliding mechanism of the sliding clamp that moves the device handle relative to the swivel handle is limited to the length of a single seed in a single stroke.

5. The seed distribution unit as claimed in claim 3, wherein the sliding gripper needs to move laterally to allow the sliding gripper to move further in one direction relative to the tube handle after the given length of movement, moving the device handle.

6. The seed distribution unit as requested in item 1 or 2, wherein the sliding gripper retracts the device handle when the handle of the slid is held in place.

7. A seed allocation unit, comprising: A device handle holder configured to grip a handle of an elongated device, wherein the elongated device includes a plurality of radiotherapy seeds at its distal end; a tube handle gripper configured to grip a handle of a tube, wherein the tube is within the elongated device; and a housing configured to allow movement of the device handle holder relative to the tube handle gripper, such that the tube pushes one or more seeds out of the distal end of the elongated device by retraction of the elongated device, wherein the housing is configured to allow uninterrupted retraction motion of the device handle holder relative to the tube handle gripper along the length of the one or more seeds, such that further movement is only permitted after an adjustment is performed by a human user.

8. The seed distribution unit of claim 7, wherein the device handle holder includes a guide handle used by the user to move the device handle holder in a first direction relative to the sprue handle gripper, and wherein the housing requires the guide handle to move in a second direction other than the first direction so as to move the guide handle in the first direction beyond the length of a single seed.

9. The seed allocation unit of request item 8, wherein the second direction is perpendicular to the first direction.

10. The seed distribution unit of any of claims 7 to 9, wherein the device handle holder includes a ratchet that prevents the device handle holder from moving backward after the length of a seed has been moved unless a ratchet release button is pressed.

11. The seed dispensing unit of any one of claims 7 to 9, wherein the housing includes one or more ball plungers that restrict the uninterrupted movement of the device handle holder relative to the sprue handle gripper to the length of a single seed.

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