Foldably flexible radiation therapy system and method

Abstract

Systems and methods are provided for minimally invasively delivering radiation therapy to a patient, such as a bladder cancer patient. The radiation therapy system includes one or more catheters that can be introduced into the patient's anatomy through a sheath using an intraluminal approach. A proximal end of the one or more catheters is coupled to an afterloader for selectively delivering radiation therapy, and a distal portion of the one or more catheters is transitionable from a non-coiled delivery state within the sheath to a coiled deployed state having a spherical shape within the patient's anatomy, such that the one or more catheters contact at least a portion of the anatomy in the deployed state.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 066,789, filed August 17, 2020, the entire contents of which are incorporated herein by reference.

[0002] This application relates generally to systems and methods using foldable, bendable devices to improve the delivery of radiation therapy to treat muscle-invasive bladder cancer (MIBC). [Background technology]

[0003] The standard treatment for bladder cancer, including muscle-invasive bladder cancer (MIBC), is radical cystectomy with pelvic lymphadenectomy, with or without neoadjuvant brachytherapy. A flexible catheter that can be implanted in the bladder wall is used to administer brachytherapy, a form of radiation therapy in which a radioactive source is placed in or near target tissue.

[0004] Brachytherapy may be used to treat cancer in cases of small tumors or locally advanced tumors. The thin nature of the bladder wall lends itself to the non-invasive, superficial application of brachytherapy. Brachytherapy allows the radiation source to be precisely positioned at the tumor treatment site, allowing high radiation doses to be applied to a small area, such as a tumor, without harming surrounding healthy tissue.

[0005] The radiation source used for high-dose-rate brachytherapy is typically delivered via a technique known as afterloading, which involves precisely positioning a non-radioactive applicator at the treatment site, which is then loaded with the radiation source. Remote afterloading systems provide health care professionals with protection from radiation exposure by securing the radiation source in a shielded enclosure. For example, a remote afterloader may be a small, sealed, 10-curie (1000 psi) battery attached to the end of a stainless steel drive wire. 192 May contain an iridium stepping source.

[0006] Prior to delivering the applicator to the treatment site within the patient, the target treatment site may be determined using MRI-based planning. Once the applicator is properly positioned within the patient, it is connected to an afterloader machine (which houses the radioactive source) through a series of flexible connecting guide tubes. The radioactive source is delivered from the afterloader to a pre-specified location within the applicator. The radioactive source remains in place for a pre-specified length of time, also according to the treatment plan, after which it is returned along the tube to the afterloader. Since the introduction of afterloading catheters, it has been observed that the majority of documented toxicities are transient local ulcerations at the implantation site.

[0007] Brachytherapy for bladder cancer is currently delivered using invasive techniques, such as tissue-penetrating applications using needles or catheters. For example, brachytherapy catheters can be implanted via either an open retropubic approach or an endoscopic surgical approach, as described in "GEC-ESTRO / ACCROP ​​Recommendations for Bladder-Sparing Treatment with Brachytherapy for Muscle-Invasive Bladder Carcinoma" by Bradley R. Pieters et al. Complications of current treatment techniques include urinary tract infection, wound dehiscence, postoperative ileus, hydronephrosis due to distal urethral obstruction, bladder bleeding, and pulmonary embolism. Additionally, acute side effects associated with brachytherapy include localized bruising, swelling, bleeding, discharge, or discomfort within the implantation area. Furthermore, current applicators and methods are inadequate for treating bladder cancer patients because tumors are difficult to target within the bladder. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Provisional Patent Application No. 63 / 066,789 Summary of the Invention [Problem to be solved by the invention]

[0009] In light of the above, it would be desirable to provide a minimally invasive system and method that more efficiently targets tumor cells within the bladder. [Means for solving the problem]

[0010] Provided herein are radiation therapy treatment systems and methods for treating a patient. For example, the radiation therapy system includes a sheath having a proximal end, a distal end, and one or more lumens extending therebetween, and one or more catheters, e.g., one, two, or four catheters, independently movable within the one or more lumens of the sheath. The one or more catheters have a distal portion that is transitionable from a non-coiled delivery state to a coiled deployed state having a spherical shape within a patient's anatomy, e.g., the bladder. In addition, in the coiled deployed state, the one or more catheters are capable of selectively delivering radiation therapy to a target area within the anatomy. For example, each of the one or more catheters can be individually activated to deliver radiation.

[0011] The distal portions of the one or more catheters may be flexible and / or made of a shape-memory material. Thus, the distal portions of the one or more catheters can transition from a non-coiled delivery state to a coiled deployed state when exposed beyond the distal end of the sheath. For example, each of the one or more catheters extends from the proximal end of the distal portion, bends around the longitudinal axis of the distal portion, increasing the radial distance between the one or more catheters and the longitudinal axis, until it reaches the midpoint of the distal portion, extends from the midpoint of the distal portion, bends around the longitudinal axis of the distal portion, decreasing the radial distance between the one or more catheters and the longitudinal axis, until it reaches the distal end of the distal portion. Thus, in the coiled deployed state, at least a portion of the one or more catheters contacts the inner wall of the patient's bladder. In some embodiments, in the coiled deployed state, the bulbous proximal end of the distal portion of one or more catheters can be at a preselected angle from the longitudinal axis of the sheath.

[0012] Also, in the coiled deployed state, each curved portion of the distal portion of the one or more catheters may be at most 0.5 cm from an adjacent curved portion of the distal portion of the one or more catheters. Each of the one or more catheters may be coupled to one another at a distal end of the distal portion. Alternatively or additionally, at least one of the one or more catheters may include a catheter for performing thermotherapy, such that the distal portion of at least one of the one or more catheters applies heat while simultaneously delivering radiation.

[0013] According to one aspect of the present disclosure, a method of delivering a radiation therapy system to treat a patient is provided. For example, the method includes positioning a distal end of a sheath within a patient's anatomy; inserting one or more catheters in an uncoiled delivery state within one or more lumens of the sheath until distal portions of the one or more catheters are positioned adjacent the distal end of the sheath within the patient's anatomy; moving the sheath relative to the one or more catheters until the distal portions of the one or more catheters transition to a coiled deployed state in which the distal portions of the one or more catheters are exposed beyond the distal end of the sheath and have a spherical shape within the patient's anatomy; and selectively delivering radiation therapy to a target area within the anatomy via the distal portions of the one or more catheters in the coiled deployed state. For example, the one or more catheters may be individually activated to deliver radiation. The method may also include applying heat while simultaneously delivering radiation via at least one of the one or more catheters.

[0014] Additionally, the method may further include, after completion of the radiation treatment, moving the sheath relative to the one or more catheters until a distal portion of the one or more catheters transitions from a coiled deployment state within the patient's anatomy to a non-coiled delivery state within the one or more lumens of the sheath, and removing the sheath and the one or more catheters from the patient. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a schematic diagram of an exemplary radiation therapy system constructed in accordance with the principles of the present disclosure; [Figure 2A] FIG. 1 is a side view of an exemplary applicator having two catheters within a sheath in an uncoiled delivery state. [Figure 2B] 2B is a side view of the applicator of FIG. 2A with the catheter partially exposed from the sheath. [Figure 2C] FIG. 2C is a side view of the applicator of FIG. 2B in a delivery state with the catheter deployed. [Figure 3A] FIG. 10 is a side view of an alternative exemplary applicator having one catheter within a sheath in a non-coiled delivery state. [Figure 3B] FIG. 3B is a side view of the applicator of FIG. 3A with the catheter partially exposed from the sheath. [Figure 3C] FIG. 3C is a side view of the applicator of FIG. 3B in a delivery state with the catheter deployed. [Figure 4A] FIG. 10 is a side view of another alternative exemplary applicator having four catheters within a sheath in a non-coiled delivery state. [Figure 4B] 4B is a side view of the applicator of FIG. 4A with the catheter partially exposed from the sheath. [Figure 4C] FIG. 4C is a side view of the applicator of FIG. 4B in a delivery state with the catheter deployed. [Figure 5] 1 is a flowchart of exemplary method steps for delivering radiation therapy in accordance with the principles of the present disclosure. [Figure 6] FIG. 1 is a schematic diagram of exemplary electronics and hardware components of a computing device. [Figure 7] FIG. 1 is a cutaway view of an exemplary catheter with a heater. [Figure 8A] 1 illustrates an alternative embodiment of an applicator having two catheters constructed in accordance with the principles of the present disclosure. [Figure 8B] 1 illustrates an alternative embodiment of an applicator having two catheters constructed in accordance with the principles of the present disclosure. [Figure 8C] 1 illustrates an alternative embodiment of an applicator having two catheters constructed in accordance with the principles of the present disclosure. [Figure 8D] 1 illustrates an alternative embodiment of an applicator having two catheters constructed in accordance with the principles of the present disclosure. [Figure 9A] 1 illustrates an alternative embodiment of an applicator having one catheter constructed in accordance with the principles of the present disclosure. [Figure 9B] 1 illustrates an alternative embodiment of an applicator having one catheter constructed in accordance with the principles of the present disclosure. [Figure 9C] 1 illustrates an alternative embodiment of an applicator having one catheter constructed in accordance with the principles of the present disclosure. [Figure 9D] 1 illustrates an alternative embodiment of an applicator having one catheter constructed in accordance with the principles of the present disclosure. [Figure 10A] 1 illustrates an alternative embodiment of an applicator having four catheters constructed in accordance with the principles of the present disclosure. [Figure 10B] 1 illustrates an alternative embodiment of an applicator having four catheters constructed in accordance with the principles of the present disclosure. [Figure 10C] 1 illustrates an alternative embodiment of an applicator having four catheters constructed in accordance with the principles of the present disclosure. [Figure 10D] 1 illustrates an alternative embodiment of an applicator having four catheters constructed in accordance with the principles of the present disclosure. [Figure 11] 10 depicts another alternative embodiment of an applicator having one catheter constructed in accordance with the principles of the present disclosure. [Figure 12] 10 depicts yet another alternative embodiment of an applicator having one catheter constructed in accordance with the principles of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] These and other features of the present disclosure will become apparent from the following description and the appended claims, taken in conjunction with the accompanying drawings, through which the disclosure will be described with additional specificity and detail, with the understanding that these drawings depict only some embodiments in accordance with the disclosure and therefore should not be considered as limiting the scope of the disclosure.

[0017] In light of the above, it would be desirable to provide a minimally invasive system and method for delivering radiation therapy to a patient, e.g., a patient with bladder cancer. For example, a brachytherapy applicator could be introduced via intracavitary application, such that the brachytherapy applicator is placed inside the organ through a natural orifice. In addition, the applicator could include an expandable catheter, allowing the applicator catheter to cover a larger area within the bladder, thereby enabling more precise and effective targeting of tumor cells anywhere within the patient's bladder.

[0018] Referring now to FIG. 1 , a radiation therapy system 10 for non-invasively administering brachytherapy to a patient is provided. As depicted in FIG. 1 , the system 10 includes an applicator 100 including one or more catheters coupled to an afterloader 200 via a sheath 150, and a computing device 300. The computing device 300 may be a standalone computing device or may be incorporated into the afterloader 200. The computing device 300 may communicate with the afterloader 200 via any known wired or wireless connection (e.g., Bluetooth, Wi-Fi Direct, etc.). The sheath 150 is coupled at its proximal end to the afterloader 200. The distal end of the sheath 150 is sized and shaped to be introduced non-invasively into a patient's organ via an intraluminal approach, for example, through the patient's urethra. When the distal end of the sheath 150 is in the proper position adjacent the treatment site within the patient's bladder, the one or more catheters may be exposed beyond the distal end of the sheath 150, allowing the one or more catheters to transition from a collapsed, non-coiled delivery state within the sheath 150 to an expanded, coiled deployment state within the patient's organ.

[0019] Accordingly, one or more catheters are formed of a flexible, shape-memory material and are movably disposed within the lumen of the sheath 150. The one or more catheters are hollow structures having a proximal end coupled to the afterloader 200 and a distal region sized and shaped to be disposed within the target anatomical structure. In the coiled, deployed state, the distal region of the one or more catheters can have a shape that conforms to the target anatomical structure, such as the patient's bladder. For example, the one or more catheters can have a spherical configuration in the coiled, deployed state. Additionally, the one or more catheters have a lumen extending from their proximal end to their distal region, such that the afterloader 200 can deliver a radioactive source to a treatment site within the anatomical structure via the lumen of the one or more catheters.

[0020] As depicted in FIG. 1 , the distal regions of the one or more catheters may have a helical configuration, forming a spherical shape for the one or more catheters. The one or more catheters may be deployed within the patient's bladder so that at least some portion of the one or more catheters is adjacent to various portions of the bladder, so that the target tumor cells will be adjacent to at least some portion of the one or more catheters; the distal end of the sheath 150 need not be positioned directly adjacent to the treatment site during delivery. In other words, the one or more catheters may be deployed to cover a large surface area of ​​the interior surface of the bladder, such that the afterloader 100 can deliver the radioactive source along the one or more catheters adjacent to tumor cells essentially anywhere within the bladder. In accordance with the principles of the present disclosure, the one or more catheters may be formed by a single catheter or multiple catheters, e.g., two or four applicators, as described in more detail below. FIG. 1 depicts an applicator 100 formed from two catheters.

[0021] 2A-2C, an applicator 100 is provided having two independently controllable catheters 102, 104. Each of the catheters 102, 104 can be individually activated by an afterloader 200 to deliver radiation. As shown in FIG. 2A, the catheters 102, 104 can be positioned within the lumen of a sheath 150 in a collapsed state. According to another aspect of the present disclosure, each of the catheters 102, 104 can be positioned within its own lumen within the sheath 150. Thus, the distal end of the sheath 150, with the distal regions of the catheters 102, 104 disposed therein, can be inserted through the patient's urethra and into the patient's bladder.

[0022] 2B, the catheters 102, 104 transition from a non-coiled delivery state to a coiled deployed state within the patient's bladder when the catheters 102, 104 move relative to the sheath 150 such that distal portions of the catheters 102, 104 are exposed beyond the distal end of the sheath 150. Thus, the sheath 150 may be retracted relative to the catheters 102, 104 and / or the catheters 102, 104 may be pushed through the lumen of the sheath 150 to expose the catheters 102, 104 beyond the distal end of the sheath 150. Additionally, the catheters 102, 104 may be deployed to conform to the shape of the anatomy.

[0023] As the catheters 102, 104 transition from the uncoiled delivery state to the coiled deployed state, the distal regions of the catheters 102, 104 unfold into a helical, spherical shape. For example, the catheters 102, 104 may have a helical configuration such that each curved section of the distal region of the catheter 102 is positioned between two curved sections of the distal region of the catheter 104, or vice versa. Specifically, as each of the catheters 102, 104 extends from the distal end of the sheath 150, the catheters curve around the longitudinal axis of the distal region of the applicator 100, increasing the radial distance between the catheter 102, 104 and the longitudinal axis, until they reach the midpoint of the distal portion of the applicator 100, e.g., the portion of the spherical configuration having the largest diameter. The catheters extend from the midpoint of the distal region and continue to curve around the longitudinal axis of the applicator 100, decreasing the radial distance between the catheters 102, 104 and the longitudinal axis, until they reach the distal end of the distal region of the applicator 100. According to one aspect of the present disclosure, the distal ends of the distal portions of the catheters 102, 104 may be fixed together to facilitate stability of the applicator 100 during the transition between the uncoiled delivery state and the coiled deployed state.

[0024] 2C depicts the distal region of applicator 100 in a fully deployed, spherical configuration, allowing each curved portion of the distal region of catheters 102, 104 to contact a portion of the patient's bladder. Each curved portion of the distal region of catheters 102, 104 is spaced from an adjacent curved portion of the distal region of catheters 102, 104 by a distance D, e.g., 0.4 to 0.6 cm, preferably 0.5 cm. Thus, because the curved portions of the distal regions of catheters 102, 104 alternate from the proximal ends of the distal regions of catheters 102, 104 to the distal ends of the distal regions of catheters 102, 104, adjacent curved portions of catheter 102 are spaced at least 0.8 to 1.2 cm, preferably 1 cm, apart, and adjacent curved portions of catheter 104 are spaced at least 0.8 to 1.2 cm, preferably 1 cm, apart. Additionally, the afterloader 200 can deliver the first radioactive source in the catheter 102 and the second radioactive source in the catheter 104 such that the first and second radioactive sources are spaced apart from each other by at least a distance D at all times during operation of the applicator 100 for effective radiation treatment of the treatment site.

[0025] With the applicator 100 positioned within the bladder in a coiled, deployed state, and the curved portions of the distal regions of the catheters 102, 104 capable of contacting various portions of the patient's bladder, the afterloader 200 can deliver one or more radioactive sources to various locations along the distal regions of the catheters 102, 104, essentially adjacent to any portion within the bladder. For example, the afterloader 200 can deliver radiation to a large volume / surface by varying the location of the radioactive sources and delivering radiation for a predetermined "dwell time." One radioactive source may be delivered to a location along the distal region of the catheter 102, and another may be delivered to a location along the distal region of the catheter 104. In this manner, the system 10 should be able to administer effective radiation therapy to targeted tumor cells anywhere within the bladder, without the need to specifically position the applicator 100 adjacent to the targeted tumor cells prior to operation of the system 10.

[0026] 3A-3C, an alternative exemplary applicator is provided. Applicator 110 is configured similarly to applicator 100 of FIGS. 2A-2C, except that applicator 100 includes a single catheter 112. Thus, catheter 112 can be activated by afterloader 200 to deliver radiation to a treatment site. As shown in FIG. 3A, catheter 112 can be positioned within the lumen of sheath 150 in a collapsed state. Thus, the distal end of sheath 150, with the distal region of catheter 112 disposed therein, can be inserted through the patient's urethra and into the patient's bladder.

[0027] 3B, catheter 112 transitions from a non-coiled delivery state to a coiled deployed state within the patient's bladder when catheter 112 moves relative to sheath 150 such that a distal portion of catheter 112 is exposed beyond the distal end of sheath 150. Additionally, catheter 112 can be deployed to conform to the shape of the anatomy.

[0028] Like catheters 102 and 104, catheter 112 can transition from a collapsed, uncoiled delivery state to an expanded, coiled, deployed state, resulting in the distal region of catheter 112 expanding into a helical, spherical shape. Specifically, as catheter 112 extends from the distal end of sheath 150, catheter 112 curves around the longitudinal axis of the distal region of applicator 110, increasing the radial distance between catheter 112 and the longitudinal axis, until it reaches the midpoint of the distal section of applicator 110, e.g., the portion of the spherical configuration with the largest diameter. As catheter 112 extends from the midpoint of the distal region, it continues to curve around the longitudinal axis of applicator 110, decreasing the radial distance between catheter 112 and the longitudinal axis, until it reaches the distal end of the distal region of applicator 110.

[0029] 3C depicts the distal region of applicator 110 in a fully deployed, spherical configuration in which each curved portion of the distal region of catheter 112 can contact a portion of the patient's bladder. Each curved portion of the distal region of catheter 112 is spaced apart from an adjacent curved portion of the distal region of catheter 112 by a distance D, e.g., 0.4-0.6 cm, preferably 0.5 cm. Thus, afterloader 200 can deliver two or more radioactive source positions within catheter 112 such that the two or more radioactive source positions can be selectively spaced apart from each other by at least distance D during operation of applicator 100 for effective radiation treatment of the treatment site.

[0030] 4A-4C, an alternative exemplary applicator 120 is provided. Applicator 120 is constructed similarly to applicator 100 of FIGS. 2A-2C, except that applicator 120 includes four catheters 122, 124, 126, and 128. Each of catheters 122, 124, 126, and 128 can be individually activated by afterloader 200 to deliver radiation. As shown in FIG. 4A, catheters 122, 124, 126, and 128 can be positioned within a lumen of sheath 150 in a collapsed state. According to another aspect of the present disclosure, each of catheters 122, 124, 126, and 128 can be positioned within its own lumen within sheath 150. Thus, the distal end of sheath 150 can be inserted through the patient's urethra and into the patient's bladder, with the distal regions of catheters 122, 124, 126, 128 disposed therein.

[0031] 4B, catheters 122, 124, 126, 128 transition from a non-coiled delivery state to a coiled deployed state within the patient's bladder when catheters 122, 124, 126, 128 move relative to sheath 150 such that distal portions of catheters 122, 124, 126, 128 are exposed beyond the distal end of sheath 150. Additionally, catheters 122, 124, 126, 128 can be deployed to conform to the shape of the anatomy.

[0032] Like catheters 102 and 104, the distal regions of catheters 122, 124, 126, and 128 unfold into a helical, bulbous shape as catheters 122, 124, 126, and 128 transition from the uncoiled delivery state to the coiled, deployed state. For example, catheters 122, 124, 126, and 128 may have a continuous pattern of helical configuration in the coiled, deployed state, such that a curved portion of the distal region of catheter 122 is positioned adjacent to a curved portion of the distal region of catheter 124, which is further positioned adjacent to a curved portion of the distal region of catheter 126, which is positioned adjacent to a curved portion of the distal region of catheter 128. According to one aspect of the present disclosure, the distal ends of the distal portions of catheters 122, 124, 126, 128 may be fixed together to facilitate stability of applicator 120 during transition between the uncoiled delivery state and the coiled deployed state.

[0033] 4C depicts the distal region of applicator 120 in a fully deployed, spherical configuration in which each curved portion of the distal region of catheters 122, 124, 126, and 128 can contact a portion of the patient's bladder. Each curved portion of the distal region of catheters 122, 124, 126, and 128 is spaced from an adjacent curved portion of the distal region of catheters 122, 124, 126, and 128 by a distance D, e.g., 0.4 to 0.6 cm, preferably 0.5 cm. Thus, the curved portions of the distal regions of catheters 122, 124, 126, 128 alternate from the proximal ends of the distal regions of catheters 122, 124, 126, 128 to the distal ends of the distal regions of catheters 122, 124, 126, 128 such that adjacent curved portions of catheter 122 are spaced at least 1.6 to 2.4 cm apart, preferably 2 cm apart (a first curved portion of the distal region of catheter 122 is adjacent to a first curved portion of the distal region of catheter 124 by a distance of preferably 0.5 cm, and a second curved portion of the distal region of catheter 124 is adjacent to a first curved portion of the distal region of catheter 124 by a distance of at least 0.5 cm). The first curved portion will be adjacent to the first curved portion of the distal region of catheter 126, preferably at a distance of 0.5 cm, the first curved portion of the distal region of catheter 126 will be adjacent to the first curved portion of the distal region of catheter 128, preferably at a distance of 0.5 cm, the first curved portion of the distal region of catheter 128 will be adjacent to the second curved portion of the distal region of catheter 122, preferably at a distance of 0.5 cm, and thus the first and second curved portions of the distal region of 122 will be preferably spaced apart by 2 cm. Similarly, adjacent curved portions of catheter 124 will be spaced apart by at least 1.6 to 2.4 cm, preferably 2 cm, adjacent curved portions of catheter 126 will be spaced apart by at least 1.6 to 2.4 cm, preferably 2 cm, and adjacent curved portions of catheter 128 will be spaced apart by at least 1.6 to 2.4 cm, preferably 2 cm.Additionally, the afterloader 200 may deliver the first radioactive source in catheter 122, the second radioactive source in catheter 124, the third radioactive source in catheter 126, and / or the fourth radioactive source in catheter 128 such that the first, second, third, and / or fourth radioactive sources are spaced apart by at least a distance D from one another at all times during operation of the applicator 120 for effective radiation treatment of the treatment site.

[0034] As will be appreciated by those skilled in the art, the applicators described herein can include any number of catheters other than one, two, or four catheters, as described above. For example, an applicator can include three catheters, five catheters, or more catheters. The number of catheters an applicator has can be selected based on the target cavity to receive the therapy(ies) described herein. Additionally, each of the catheters of an applicator can have a different preselected diameter, and each of the catheters can be made from a different material depending on the therapy to be provided.

[0035] 5, an exemplary method 500 for delivering radiation therapy in accordance with the principles of the present disclosure is provided. At step 501, as described above, the distal end of sheath 150 can be positioned within a patient's anatomy, such as within the patient's bladder via an intraluminal approach through the patient's urethra. One or more catheters, e.g., catheters 102, 104, 112, 122, 124, 126, 128, of a selected applicator, e.g., applicators 100, 110, or 120, are placed within one or more lumens of sheath 150. Prior to operation of system 10, the distal end of sheath 150 need not be positioned directly adjacent to the target tumor tissue.

[0036] At step 502, sheath 150 is moved relative to a selected applicator disposed therein, such as via retracting sheath 150 or pushing the selected applicator within one or more lumens of sheath 150, until a distal region of the selected applicator is exposed beyond the distal end of sheath 150 within the patient's anatomy. As the distal region of one or more catheters of the selected applicator is exposed beyond the distal end of sheath 150, the distal region of the one or more catheters begins to transition from a non-coiled delivery state to a coiled deployed state until it is fully deployed within the anatomy.

[0037] At step 503, afterloader 200 can selectively deliver radiation treatment to a target treatment site within the anatomy via one or more radioactive sources within the lumens of one or more catheters of a selected applicator. When the radiation treatment is completed, the one or more catheters are transitioned back to a non-coiled delivery state within one or more lumens of sheath 150, and sheath 150 can be removed from the patient along with the one or more catheters of the selected applicator (step 504).

[0038] 6, an exemplary functional block diagram is shown representing hardware and software components of computing device 300. The hardware and software components of computing device 300 may include one or more processing units 301, memory 302, storage 307, communication units 303, and power sources 306, input devices 304, and output devices 305. Computing device 300 may be in communication with the Internet and / or other computing devices.

[0039] The processing unit 301 may be one or more processors configured to run an operating system 308 and / or an afterloader application 309. The afterloader application 309 running on the processing unit 301 may be adapted to control the operation of the afterloader 200 or otherwise implement and oversee the operations and actions of the afterloader 200. The afterloader application 309 may be stored in the storage 307 and adapted to be executed on the processing unit 301. The afterloader application 309 may be a software application and / or software module having one or more sets of instructions suitable for performing the operations of the controller computing device 300 described herein.

[0040] Computing device 300 may optionally run an operating system 308 stored in storage 307 and executed on processing unit 301. Operating system 308 is adapted to control the overall operation of computing device 300 and may cooperate with afterloader application 309 to implement the functionality of computing device 300 described herein. Computing device 305 may also optionally run graphics libraries, other operating systems, and / or any other application programs.

[0041] The memory 302 may include, but is not limited to, volatile memory (e.g., random access memory (RAM)), non-volatile memory (e.g., read-only memory (ROM)), flash memory, or any combination thereof. The communication unit 303 can receive and / or transmit information to other computing devices and / or peripheral devices. The communication unit 303 may be any known communication infrastructure that facilitates communication over any known wired or wireless connection, including according to any known standard, such as any IEEE 802 standard. The power source 306 may be a battery or any other external power source. The storage 307 may include, but is not limited to, removable and / or non-removable storage, such as a magnetic disk, optical disk, or tape.

[0042] Input device(s) 304 may be one or more devices coupled to or incorporated into controlling device 300 for inputting data into controlling device 300. Input device(s) 304 may include, for example, a keyboard, a mouse, a pen, a voice input device (e.g., a microphone), a touch input device (e.g., a touchpad or touchscreen), and / or a camera. Output device 305 may be any device coupled to or incorporated into computing device 300 for outputting or otherwise displaying data (e.g., a display, a speaker, a printer, etc.). As will be appreciated by those skilled in the art, computing device 300 may include additional or fewer components than those depicted in FIG. 6 and may include more than one component of each type of component.

[0043] Referring now to FIG. 7 , an optional thermotherapy applicator is depicted. Because combining radiation therapy with thermotherapy has been observed to improve cancer cell death and cure rates, it may be desirable to combine a conventional radiation therapy applicator with a thermotherapy catheter. For example, a thermotherapy applicator 130 may have functionality and structure similar to applicators 100, 110, and 120, but may further include a heater 131 along at least a portion of applicator 130. As shown in FIG. 7 , heater 131 may be disposed in a wall 135 of distal end 132 of applicator 130 such that heat is applied to targeted tissue of the patient when distal end 132 of applicator 130 is near the targeted tissue. Heater 131 may be electrically isolated from applicator 130.

[0044] The heater 131 may be connected via circuitry 133 to a power source (not shown) in electrical communication with the computing device 300. The computing device 300 may run an afterloader application 309 or a stand-alone application to selectively activate the heater 131 to heat targeted tissue. The circuitry may be connected to an independent power source or may use a power source integrated into the afterloader 200. A healthcare professional using the computing device 300 may select all catheters or only specific catheters for application of heat. Alternatively, the afterloader application 309 may automatically apply power to specific catheters based on data received from sensors and / or according to programmed instructions.

[0045] 7 depicts applicator 130 having a heating coil, it is understood that heater 131 can employ any other known heating technique. For example, heater 131 can be a radio frequency (RF) electrode. Alternatively, heater 131 can be one or more fluid channels in wall 135 of applicator 130, with heated fluid introduced into the one or more fluid channels to apply heat to the targeted tissue.

[0046] 8A-8D, an exemplary applicator having two catheters is provided. Applicators 100′, 100″, 100′″, and 100′″ may be similar in configuration to applicator 100 of FIGS. 2A-2C, except that in the deployed state, the distal end of each catheter exits sheath 150 and begins to form a helical spherical shape at a predetermined angle relative to the longitudinal axis of each applicator and sheath 150. For example, as shown in FIG. 8A, in the deployed state, the distal ends of catheters 102′, 104′ of applicator 100′ exit sheath 150 and begin to form a helical spherical shape at a 45-degree angle relative to the longitudinal axis of applicator 100′ and sheath 150.

[0047] As shown in FIGURE 8B, in the unfolded, deployed state, the distal ends of catheters 102'', 104'' of applicator 100'' exit sheath 150 and begin to form a helical, spherical shape that is angled 90 degrees from the longitudinal axis of applicator 100'' and sheath 150. As shown in FIGURE 8C, in the unfolded, deployed state, the distal ends of catheters 102'''', 104'''' of applicator 100''' exit sheath 150 and begin to form a helical, spherical shape that is angled 135 degrees from the longitudinal axis of applicator 100''' and sheath 150. As shown in FIG. 8D, in the unfolded, deployed state, the distal ends of catheters 102'''', 104'''' of applicator 100'''' exit sheath 150 and begin to form a helical, spherical shape that is at an angle of 180 degrees from the longitudinal axis of applicator 100'''' and sheath 150.

[0048] 9A-9D, an alternative exemplary applicator having a single catheter is provided. Applicators 110′, 110″, 110′″, and 110′″ may be similar in configuration to applicator 110 of FIGS. 3A-3C, except that in the deployed state, the distal end of each catheter exits sheath 150 and begins to form a helical spherical shape at a predetermined angle relative to the longitudinal axis of each applicator and sheath 150. For example, as shown in FIG. 9A, in the deployed state, the distal end of catheter 112′ of applicator 100′ exits sheath 150 and begins to form a helical spherical shape at a 45-degree angle relative to the longitudinal axis of applicator 110′ and sheath 150.

[0049] As shown in FIG. 9B, in the unfolded, deployed state, the distal end of catheter 112'' of applicator 110'' exits sheath 150 and begins to form a helical, spherical shape that is angled 90 degrees from the longitudinal axis of applicator 110'' and sheath 150. As shown in FIG. 9C, in the unfolded, deployed state, the distal end of catheter 112'''' of applicator 110'''' exits sheath 150 and begins to form a helical, spherical shape that is angled 135 degrees from the longitudinal axis of applicator 110''' and sheath 150. As shown in FIG. 9D, in the unfolded, deployed state, the distal end of catheter 112'''' of applicator 110'''' exits sheath 150 and begins to form a helical, spherical shape that is angled 180 degrees from the longitudinal axis of applicator 110'''' and sheath 150.

[0050] 10A-10D, an alternative exemplary applicator having four catheters is provided. Applicators 120′, 120″, 120′″, and 120′″ may be similar in configuration to applicator 120 of FIGS. 4A-4C, except that in the deployed state, the distal end of each catheter exits sheath 150 and begins to form a helical spherical shape at a predetermined angle relative to the longitudinal axis of each applicator and sheath 150. For example, as shown in FIG. 10A, in the deployed state, the distal ends of catheters 122′, 124′, 126′, and 128′ of applicator 120′ exit sheath 150 and begin to form a helical spherical shape at a 45-degree angle relative to the longitudinal axis of applicator 120′ and sheath 150.

[0051] As shown in FIGURE 10B, in the unfolded, deployed state, the distal ends of catheters 122", 124", 126", 128" of applicator 100" exit sheath 150 and begin to form a helical, spherical shape that is angled 90 degrees from the longitudinal axis of applicator 120" and sheath 150. As shown in FIGURE 10C, in the unfolded, deployed state, the distal ends of catheters 122"", 124"", 126'", 128'" of applicator 120"' exit sheath 150 and begin to form a helical, spherical shape that is angled 135 degrees from the longitudinal axis of applicator 120" and sheath 150. As shown in FIG. 10D, in the unfolded, deployed state, the distal ends of catheters 122'''', 124'''', 126'''', and 128'''' of applicator 120'''' exit sheath 150 and begin to form a helical, spherical shape that is at an angle of 180 degrees from the longitudinal axis of applicator 120'''' and sheath 150.

[0052] As explained above, those skilled in the art will understand that the applicators described herein can include any number of catheters other than the one, two, or four catheters described above. For example, the applicator can include three catheters, five catheters, or more catheters. Additionally, the catheter(s) exiting the sheath 150 can begin to form a helical, spherical shape at any angle relative to the longitudinal axis of the applicator and sheath 150 other than the 0, 45, 95, 135, and 180 degrees described above. For example, the angle can be 20, 30, 225, 270, etc.

[0053] Referring now to FIG. 11 , another alternative exemplary applicator is provided. As shown in FIG. 11 , applicator 160 can include a catheter 162 that can be activated by an afterloader 200 to deliver radiation in accordance with the principles of the present disclosure. Catheter 162 can be delivered to a target treatment site within a patient in a collapsed delivery state within sheath 150 and self-deploy upon exposure from sheath 150. As shown in FIG. 11 , in the deployed state, the distal portion of catheter 162 can have a preformed spherical or semi-dome shape such that the distal portion of catheter 162 has multiple proximally and distally extending amplitude shapes that proceed circumferentially about the longitudinal axis of applicator 160 and sheath 150. While FIG. 11 depicts catheter 162 having six amplitude shapes, those skilled in the art will understand that catheter 162 can have fewer or more than six amplitude shapes about the longitudinal axis of applicator 160 and sheath 150. 11 depicts applicator 160 having one catheter, applicator 160 may include more than one independently controllable catheter that together form a spherical or semi-dome-like shape with multiple proximally and distally extending amplitudes that progress circumferentially about the longitudinal axis of applicator 160 and sheath 150.

[0054] Referring now to FIG. 12 , another alternative exemplary applicator is provided. As shown in FIG. 12 , applicator 170 can include catheter 172 that can be activated by afterloader 200 to deliver radiation in accordance with the principles of the present disclosure. Catheter 172 can be delivered to a target treatment site within a patient in a collapsed delivery state within sheath 150 and self-deploy upon exposure from sheath 150. As shown in FIG. 12 , in the deployed state, the distal portion of catheter 172 can have a preformed spherical or semi-dome shape such that the distal portion of catheter 172 has multiple amplitude shapes extending transversely to the proximal-distal direction, running from the proximal end of the distal portion of applicator 170 to the distal end of the distal portion of applicator 170 around the longitudinal axis of applicator 160 and sheath 150 (as opposed to the amplitude shapes extending in the proximal / distal direction of catheter 162 of FIG. 11 ). For example, the diameter of the multiple circumferentially extending amplitude shapes of catheter 172 may increase from the proximal end of the distal portion of applicator 170 to the distal end of the distal portion of applicator 170 .

[0055] 12 depicts catheter 172 having four amplitude profiles, those skilled in the art will understand that catheter 172 may have fewer or more amplitude profiles around the longitudinal axis of applicator 170 and sheath 150. Additionally, the distal end of applicator 170 may curve radially inward to form a more spherical shape. For example, the diameters of the multiple circumferential amplitude profiles of catheter 172 may increase from the proximal end of the distal portion of applicator 170 toward the midpoint of the distal portion of applicator 170, and then decrease from the midpoint of the distal portion of applicator 170 toward the distal end of the distal portion of applicator 170. Additionally, although FIG. 12 depicts applicator 170 having one catheter, applicator 170 may include more than one independently controllable catheter, which together form a spherical or semi-dome-like shape having multiple circumferentially extending amplitude shapes that extend around the longitudinal axis of applicator 160 and sheath 150 from the proximal end of the distal portion of applicator 170 to the distal end of the distal portion of applicator 170.

[0056] Examples of the present invention are as follows. [Example 1] 1. A radiation therapy system for treating a patient, comprising: a sheath having a proximal end, a distal end, and one or more lumens extending therebetween; one or more catheters independently movable within the one or more lumens of the sheath, a distal portion of the one or more catheters configured to transition from a non-coiled delivery state to a coiled deployed state having a spherical shape within the patient's anatomy, the one or more catheters configured to selectively deliver radiation therapy to a target area within the anatomy in the coiled deployed state. [Example 2] In the system described in Example 1, The system includes two catheters. [Example 3] In the system described in Example 1, The system includes four catheters. [Example 4] In the system described in Example 1, At least the distal portion of the one or more catheters is made of a shape memory material. [Example 5] In the system described in Example 1, A system wherein at least the distal portion of the one or more catheters is flexible. [Example 6] In the system described in Example 1, The system, wherein the distal portion of the one or more catheters is configured to transition from the uncoiled delivery state to the coiled deployed state when exposed beyond the distal end of the sheath. [Example 7] In the system described in Example 1, A system wherein each of the one or more catheters is configured to be individually activated to deliver radiation. [Example 8] In the system described in Example 1, The system of Example 1, wherein in the coiled deployed state, the spherically shaped proximal end of the distal portion of the one or more catheters is at a preselected angle from the longitudinal axis of the sheath. [Example 9] In the system described in Example 1, each of the one or more catheters extends from a proximal end of the distal section, curves about the longitudinal axis of the distal section while increasing the radial distance between the one or more catheters and the longitudinal axis of the distal section to a midpoint of the distal section, and extends from the midpoint of the distal section, curves about the longitudinal axis of the distal section while decreasing the radial distance between the one or more catheters and the longitudinal axis of the distal section to a distal end of the distal section. [Example 10] In the system described in Example 1, wherein in the coiled deployed state, each curved portion of the distal portion of the one or more catheters is at most 0.5 cm from an adjacent curved portion of the distal portion of the one or more catheters. [Example 11] In the system described in Example 1, The system, wherein the one or more catheters comprise a plurality of catheters, each of the plurality of catheters being coupled to one another at a distal end of the distal section. [Example 12] In the system described in Example 1, The system, wherein the distal portion of the one or more catheters is configured to transition to the coiled deployed state within the patient's bladder. [Example 13] In the system described in Example 12, In the coiled deployed state, at least a portion of the one or more catheters contacts an inner wall of the patient's bladder. [Example 14] In the system described in Example 1, wherein at least one of the one or more catheters comprises a catheter for performing hyperthermia therapy, and wherein the distal portion of at least one of the one or more catheters is configured to apply heat while simultaneously delivering radiation. [Example 15] 1. A method of delivering a radiation therapy system to treat a patient, comprising: positioning a distal end of a sheath within a patient's anatomy; inserting one or more catheters in an uncoiled delivery state within one or more lumens of the sheath until a distal portion of the one or more catheters is positioned adjacent the distal end of the sheath within the anatomy of the patient; moving the sheath relative to the one or more catheters until the distal portions of the one or more catheters are exposed beyond the distal end of the sheath and transition to a coiled, deployed state having a spherical shape within the anatomy of the patient; and selectively delivering radiation therapy to a target area within the anatomical structure via the distal portion of the one or more catheters in the coiled deployed state. [Example 16] In the method described in Example 15, The method, wherein positioning the distal end of the sheath within the anatomy of the patient comprises positioning the distal end of the sheath within the patient's bladder. [Example 17] In the method described in Example 16, In the coiled deployed state, at least a portion of the distal portion of the one or more catheters contacts an inner surface of the patient's bladder. [Example 18] In the method described in Example 15, The method, wherein selectively administering radiation therapy via the distal portions of the one or more catheters comprises individually activating the one or more catheters to deliver radiation. [Example 19] In the method described in Example 15, The method further comprising applying heat while simultaneously delivering radiation via at least one of the one or more catheters. [Example 20] In the method described in Example 15, moving the sheath relative to the one or more catheters after completion of the radiation treatment until the distal portions of the one or more catheters transition from the coiled deployed state within the anatomy of the patient to the uncoiled delivery state within the one or more lumens of the sheath; removing the sheath and the one or more catheters from the patient. While various illustrative embodiments of the invention have been described above, it will be apparent to those skilled in the art that various changes and modifications can be made to the embodiments without departing from the invention. It is further understood that the systems and methods described herein can be used to deliver radiation therapy to organs other than the bladder, and can be used as part of other therapies, including, for example, hyperthermia, cryotherapy, laser therapy, ultrasound therapy, radiofrequency ablation (RFA) therapy, microwave therapy, electroporation therapy, local drug therapy, and drug injection therapy. It is intended that the appended claims cover all such changes and modifications that fall within the true spirit and scope of the invention. [Explanation of symbols]

[0057] 10 Radiation Therapy System 100, 100', 100'', 100'''', 100'''' applicators 102, 102', 102'', 102'''', 102'''' catheter 104, 104', 104'', 104''', 104'''' catheter 110, 110', 110'', 110'''', 110'''' applicator 112, 112', 112'', 112'''', 112'''' catheter 120, 120', 120'', 120'''', 120'''' applicator 122, 122', 122'', 122'''', 122'''' catheter 124, 124', 124'', 124'''', 124'''' catheter 126, 126', 126'', 126'''', 126'''' catheters 128, 128', 128'', 128'''', 128'''' catheters 130 Thermotherapy Applicator 131 Heater 132 distal end 133 Circuit Configuration 135 Wall 150 sheath 160 Applicator 162 Catheter 170 Applicator 172 Catheter 200 Afterloader 300 computing devices 301 Processing Unit 302 memory 303 Communication Unit 304 Input Devices 305 Output Devices 306 Power Source 307 Storage 308 Operating Systems 309 Afterloader Application D distance

Claims

1. 1. A radiation therapy system for treating a patient, comprising: a sheath having a proximal end, a distal end, and one or more lumens extending therebetween; one or more catheters independently movable within the one or more lumens of the sheath, wherein a distal portion of the one or more catheters is configured to transition from a non-coiled delivery state to a coiled deployed state having a spherical shape within the patient's anatomy, the one or more catheters being configured to selectively deliver radiation therapy to a target area within the anatomy in the coiled deployed state, wherein a proximal end of the spherical shape of the distal portion of the one or more catheters is not parallel to a longitudinal axis of the sheath in the coiled deployed state.

2. 10. The system of claim 1, The system includes two catheters.

3. 10. The system of claim 1, The system includes four catheters.

4. 10. The system of claim 1, At least the distal portion of the one or more catheters is made of a shape memory material.

5. 10. The system of claim 1, A system wherein at least the distal portion of the one or more catheters is flexible.

6. 10. The system of claim 1, The system, wherein the distal portion of the one or more catheters is configured to transition from the uncoiled delivery state to the coiled deployed state when exposed beyond the distal end of the sheath.

7. 10. The system of claim 1, The system, wherein each of the one or more catheters is configured to be individually activated to deliver radiation.

8. 10. The system of claim 1, each of the one or more catheters extends from a proximal end of the distal section, curves about the longitudinal axis of the distal section while increasing the radial distance between the one or more catheters and the longitudinal axis of the distal section to a midpoint of the distal section, and extends from the midpoint of the distal section, curves about the longitudinal axis of the distal section while decreasing the radial distance between the one or more catheters and the longitudinal axis of the distal section to a distal end of the distal section.

9. 10. The system of claim 1, The system, wherein in the coiled deployed state, the coil comprises a plurality of bent portions, each of the plurality of bent portions of the coil being at most 0.5 cm from an adjacent bent portion of the plurality of bent portions of the coil.

10. 10. The system of claim 1, The one or more catheters comprise a plurality of catheters, each of the plurality of catheters coupled to one another at a distal end of the distal section.

11. 10. The system of claim 1, The system, wherein the distal portion of the one or more catheters is configured to transition to the coiled deployed state within the patient's bladder.

12. 12. The system of claim 11, In the coiled deployed state, at least a portion of the one or more catheters contacts an inner wall of the patient's bladder.

13. 10. The system of claim 1, wherein at least one of the one or more catheters comprises a catheter for performing hyperthermia therapy, and wherein the distal portion of at least one catheter of the one or more catheters is configured to apply heat while simultaneously delivering radiation.

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