Medical devices, systems, and related methods

Abstract

A medical device for use during radiotherapy may include a longitudinal body configured to be positioned within a urethra. The longitudinal body may include a lumen, a distal end, and a proximal end. The first balloon may be coupled to the distal portion of the longitudinal body and fluidly connected to a first port at the proximal end of the longitudinal body. A second balloon may be positioned between the first balloon and the proximal end of the longitudinal body and fluidly connected to a second port at the proximal end of the longitudinal body.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 63 / 484,237, filed on February 10, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] Various aspects of the present disclosure generally relate to systems, devices, and methods for improving radiation therapy. More specifically, various aspects of the present disclosure relate to systems, devices, and / or methods for penile bulb repositioning and / or radiation blocking via a medical device, such as a catheter assembly. Background Art

[0004] Radiation therapy uses high-energy rays or particles to kill cancer cells. Radiation therapy can be used to treat prostate cancer, for example. Intensity-modulated radiation therapy (IMRT) includes the use of, for example, ions and intensity-modulated electromagnetic radiation therapy, which uses, for example, x-rays, to administer treatment to a subject. IMRT is a common type of external beam radiation therapy used for prostate cancer. This intensity-modulated radiation therapy uses a computer-driven machine that moves around the patient while delivering radiation. In addition to conforming the beams and aiming them at the prostate from several angles, the intensity (power) of the beams can be adjusted to limit the dose of radiation that reaches nearby normal tissue. This allows doctors to deliver even higher radiation doses to the cancer while limiting the radiation delivered to normal tissue. However, approximately 25-50% of men who undergo IMRT as a treatment for prostate cancer experience erectile dysfunction in the years following treatment. Radiation dose to the bulbar penis is associated with sexual intercourse ability. For example, in a recent study of 276 patients, an average radiation dose of 20 Gy or more to the bulbar penis was predictive of erectile dysfunction.

[0005] Therefore, there is a need for a system, device, and / or method for repositioning the bulb of the penis to avoid radiation and / or prevent radiation exposure to the bulb of the penis during radiation therapy for prostate cancer. Summary of the Invention

[0006] Various aspects of the present disclosure include medical systems and devices having catheters and methods of using the same, for example, methods of delivering a catheter to a target site in a patient and / or methods of operating a catheter to, for example, move the patient's bulbus penis and / or prevent the patient's bulbus penis from receiving radiation. Each of the aspects disclosed herein can include one or more of the features described in conjunction with any of the other disclosed aspects.

[0007] According to at least one aspect, a medical device for use during radiation therapy may include a longitudinal body configured to be positioned within a urethra. The longitudinal body may include a lumen, a distal end, and a proximal end. A first balloon may be coupled to the distal portion of the longitudinal body and fluidically connected to a first port located at the proximal end of the longitudinal body. A second balloon may be positioned between the first balloon and the proximal end of the longitudinal body and fluidically connected to a second port located at the proximal end of the longitudinal body.

[0008] Any of the aspects disclosed herein may have any of the following features, alone or in any combination. The medical device may be a urinary catheter. The medical device may further include at least one marker adjacent to the second balloon. The at least one marker may be a first marker, and the medical device may further include a second marker. The first marker may be positioned on a side of the second balloon opposite the second marker. In a first configuration, the second balloon may be filled with barium sulfate. Each of the first port and the second port may be configured to be coupled to a syringe. The second balloon may be configured to transition between a fully deflated configuration and a fully expanded configuration. In the fully expanded configuration, the second balloon may have a diameter between 7 mm and 12 mm. The medical device may further include a third balloon positioned adjacent to the second balloon. The medical device may further include an opening fluidically connected to the lumen of the medical device. The opening may be configured to allow urine to pass therethrough.

[0009] In another aspect, a medical device for use during radiation therapy can include a longitudinal body configured to be positioned within the urethra. The longitudinal body can include a lumen, a distal end, and a proximal end. A first balloon can be coupled to the distal portion of the longitudinal body and fluidically connected to a first port located at the proximal end of the longitudinal body. The first balloon can be configured to be positioned within the abdomen. A second balloon can be positioned between the first balloon and the proximal end of the longitudinal body and fluidically connected to a second port located at the proximal end of the longitudinal body. The second balloon can be configured to be positioned adjacent to the bulb of the penis and configured to block radiation.

[0010] Any of the aspects disclosed herein may include any of the following features, alone or in any combination. The medical device may be a urinary catheter. The medical device may further include at least one marker adjacent to the second balloon. The at least one marker may be a first marker, and the device may further include a second marker. The first marker may be positioned on a side of the second balloon opposite the second marker. In a first configuration, the second balloon may be filled with barium sulfate. The opening may be fluidically connected to the lumen of the medical device. The opening may be configured to allow urine to pass therethrough.

[0011] In one aspect, a method for performing radiation therapy on a patient may include positioning a medical device within the patient's urethra, the medical device comprising: a longitudinal body configured to be positioned within the urethra. The longitudinal body may include a lumen, a distal end, and a proximal end. The medical device may further include: a first balloon coupled to the distal portion of the longitudinal body and fluidly connected to a first port located at the proximal end of the longitudinal body; and a second balloon positioned between the first balloon and the proximal end of the longitudinal body and fluidly connected to a second port located at the proximal end of the longitudinal body. The method may further include: positioning the second balloon adjacent to the patient's penis bulb; expanding the second balloon; and applying radiation to the patient.

[0012] Any of the aspects described herein may include any of the following features, alone or in any combination. The radiation therapy may be intensity modulated radiation therapy (IMRT) or stereotactic body radiation therapy (SBRT). The method may further include blocking the applied radiation using a second balloon. The method may further include inflating the second balloon with barium sulfate. The method may further include positioning at least one marker of the medical device adjacent to the bulb of the penis. The method may further include inflating the first balloon located within the patient's abdomen. The second balloon may be configured to transition between a fully deflated configuration and a fully expanded configuration. In the fully expanded configuration, the second balloon may have a diameter between 7 mm and 12 mm.

[0013] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the disclosure and, together with the description, serve to explain the principles of the disclosure.

[0015] Figure 1 is a perspective view of an exemplary medical device according to aspects of the present disclosure.

[0016] Figure 2 According to various aspects of the present disclosure Figure 1 Side partial cross-sectional view of a medical device positioned within the urethra.

[0017] Figure 3 According to various aspects of the present disclosure Figure 1 Method of operation of a medical device.

[0018] Figure 4 is a perspective view of an exemplary medical device according to aspects of the present disclosure.

[0019] Figure 5 is a perspective view of another exemplary medical device according to aspects of the present disclosure. DETAILED DESCRIPTION

[0020] Reference will now be made in detail to various aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the portion of the device that is farthest from the user when introduced into the patient's body. In contrast, the term "proximal" refers to the portion of the device that is closest to the user when placed in the patient's body. In all figures included in this application, arrows labeled "P" and "D" are used to indicate the proximal and distal directions in the figures. As used herein, the terms "comprises," "comprising," "including," or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example," not "ideal." Furthermore, relative terms, such as, for example, "approximately," "substantially," "substantially," and the like, are used to indicate a possible variation of 10% from a stated value or range.

[0021] Embodiments of the present disclosure seek to improve a physician's ability to use a medical device to move a patient's bulbus penis and / or block the patient's bulbus penis from receiving radiation. The medical devices, systems, and methods discussed herein can help reduce exposure of the bulbus penis and / or other portions of a patient's anatomy to radiation during radiation therapy, help reduce the likelihood of a patient experiencing erectile dysfunction after radiation therapy, and reduce damage to portions of a patient's anatomy during radiation therapy, among other things.

[0022] Figure 1A perspective view of a medical device 100 is shown. The medical device 100 may include a urinary catheter, such as a modified Foley catheter. The medical device 100 may include a longitudinal body 101 including a distal end 102 and a proximal end 103. The body 101 may be tubular, having one or more lumens extending longitudinally through the body 101 from a distal opening 112 (at the distal end 102) to a proximal opening 113 (at the proximal end 103). The central longitudinal axis 199 of the medical device 100 may extend through the opening 112, the central lumen, and the opening 113. In some examples, one or more additional openings 114 may be positioned circumferentially around the body 101 at the distal end 102, and the one or more additional openings 114 may be fluidically connected to the central lumen. In some examples, the one or more additional openings 114, the distal opening 112, and / or the proximal opening 113 may be omitted. In such examples, the medical device 100 may be removed immediately after surgery. For example, the medical device 100 may include one or more additional openings 114 and the proximal opening 113 , but the distal opening 112 may be omitted.

[0023] The first balloon 104 can be positioned at the distal portion of the body 101, proximal to the distal end 102. The first balloon 104 can be reversibly inflated and can extend around the radially outer surface 130 of the body 101 relative to the central longitudinal axis 199 of the body 101. The first balloon 104 is Figure 1 104 is shown in an expanded configuration and can be spherical when in the expanded configuration. In other examples, the first balloon 104 can be elliptical, tubular, rectangular, spiral or any other shape when in the expanded configuration. When the first balloon 104 is in a deflated configuration, the first balloon 104 can be substantially flush with the radially outer surface 130 of the body 101. The first balloon 104 can have a single chamber or a single chamber configured to receive fluid within the first balloon 104. A first independent catheter (not shown) can fluidically connect the first balloon 104 to the first valve / port 106 located at the proximal end 103 of the body 101, and the first independent catheter can have a proximal opening 116. The first lumen of the first independent catheter can be non-fluidically connected to the central lumen of the body 101, and in some examples, the first independent catheter can be completely positioned within the body 101. In some examples, the central lumen of the body 101 can include multiple catheters.

[0024] In some examples, the first sacculus 104 can have a limited capacity and is only configured to receive approximately 2.0 milliliters of fluid to approximately 3.0 milliliters of fluid. Additionally or alternatively, the first sacculus 104 can be configured to receive approximately 2.0 milliliters of fluid to approximately 100 milliliters of fluid, approximately 4.0 milliliters of fluid to approximately 80.0 milliliters of fluid or approximately 5.0 to approximately 10.0 milliliters of fluid. However, such amount is merely exemplary, and the first sacculus 104 can be configured to receive the fluid of any appropriate amount. The fluid received by the first sacculus 104 can comprise the fluid of such as sterile water or saline. When fluid was received in the first sacculus 104, this first sacculus could be inflated to its complete inflation configuration (or complete expansion configuration). By using a syringe or similar instrument, the fluid of appropriate volume can be injected by the first valve 106, and passes the first independent conduit and enters the first sacculus 104.

[0025] The second balloon 105 can be coupled to the body 101 and positioned between the distal end 102 of the body 101 and the proximal end 103 of the body 101. The second balloon 105 can be reversibly inflated and can extend around the radially outer surface 130 of the body 101 relative to the central longitudinal axis 199 of the body 101. The second balloon 105 is Figure 1 101 . The second balloon 105 is shown in an expanded configuration and can be spherical when in the expanded configuration. In other examples, the second balloon 105 can be elliptical, tubular, rectangular, spiral, or any other shape when in the expanded configuration. In some examples, the second balloon 105 can have a diameter of approximately 7.0-12 mm when in the fully expanded configuration. When the second balloon 105 is in the deflated configuration, the second balloon 105 can be substantially flush with the radially outer surface 130 of the body 101. The second balloon 105 can have a single chamber located within the second balloon 105 that is configured to receive a fluid. A second independent conduit (not shown) can fluidically connect the second balloon 105 to a second valve / port 108 located at the proximal end 103 of the body 101, and the second independent conduit can have a proximal opening 118. The second lumen of the second independent conduit can not be fluidically connected to the central lumen of the body 101, and in some examples, the second independent conduit can be completely positioned within the body 101. In some examples, the second independent conduit of the body 101 can include multiple conduits.

[0026] In some examples, the second balloon 105 can have a limited capacity and be configured only to receive between approximately 2.0 milliliters and approximately 10.0 milliliters of fluid (such as sterile water, saline, or contrast agent) to inflate the second balloon 105 to its fully inflated configuration (or fully expanded configuration). The example capacities of the second balloon 105 provided above are merely exemplary, and the second balloon 105 can have alternative capacities. By using a syringe or similar instrument, a suitable volume of fluid can be injected through the second valve 108 and passed through a second independent catheter into the second balloon 105. Although the second balloon 105 is shown as being located at the approximate longitudinal midpoint of the body 101, the second balloon 105 can be positioned at any portion of the body 101. In other examples, the medical device 100 can include a plurality of second balloons 105 positioned between the distal end 102 and the proximal end 103. In some examples, medical device 100 may not include first balloon 104 , and may include only second balloon 105 positioned between distal end 102 and proximal end 103 .

[0027] The body 101 may include at least one marking 135, 136. Figure 1 As shown in , the body 101 may include two markers 135, 136. The markers 135, 136 can be positioned on the body 101, adjacent to the second balloon 105. The markers 135, 136 can be visible to the human eye under a computed tomography (CT) scan and / or under an x-ray scan. The markers 135, 136 can extend circumferentially at least partially around the body 101, and in some examples, can extend completely around the body 101. The markers 135, 136 can include tungsten or other heavy metals to block x-rays and allow a user to see the markers 135, 136 under an x-ray scan, a CT scan, or other medical image. In some examples, the markers 135, 136 can include a metal ring extending around the body 101. The markers 135, 136 can be positioned on opposite sides of the second balloon 105. For example, marker 135 can be positioned on a first side of the second balloon 105 (e.g., distal to the second balloon 105), and marker 136 can be positioned on a second side of the balloon 105 opposite the first side (e.g., proximal to the second balloon 105).

[0028] Figure 2 The medical device 100 is shown positioned within the urethra 205 of a patient, with portions of the patient's anatomy shown in cross-section. Figure 2As shown in , once the first balloon 104 is positioned within the abdomen 201, the first balloon 104 can be transformed into an expanded configuration. The abdomen 201 can be a bladder abdomen. By expanding the first balloon 104 in the abdomen 201, the medical device 100 can be prevented from moving proximally through the urethra 205 and, therefore, from falling out of the patient's urethra, thereby effectively anchoring the medical device 100 to the patient. The second balloon 105 can be positioned adjacent to the patient's penis bulb 203, can be positioned proximal to the prostate 213, and can be positioned distal to the scrotum 204. Figure 2 As shown in FIG, when the second balloon 105 is transitioned to the expanded configuration, in some examples, the penile bulb 203 can be pushed proximally, away from the prostate 213.

[0029] Urine and other bodily fluids may travel through one or more of the one or more additional openings 114 or distal openings 112 , through the central lumen of body 101 , and out proximal opening 113 to drain fluids from the patient's abdomen 201 .

[0030] In some examples, the second balloon 105 can be configured to act as a radiation shield and block radiation from moving through the second balloon 105. For example, the second balloon 105 can be made of a material that blocks radiation. In some examples, the second balloon 105 can be filled with a fluid (e.g., a liquid) that blocks radiation, such as barium sulfate or another heavy metal solution (e.g., a contrast agent). In order to block radiation, the second balloon 105 can deflect, absorb and / or otherwise prevent radiation from traveling through the second balloon 105. If the second balloon 105 is filled with a fluid that blocks radiation, then after the radiation is applied, the second balloon 105 can be flushed with saline or another fluid. Therefore, if the medical device 100 remains in the patient's body between radiation treatments (e.g., for urination function), residual radiation blocking agent (e.g., contrast agent, barium sulfate, or another solution) can be eliminated.

[0031] Figure 3A schematic diagram of an exemplary method 300 for operating a medical device 100 is shown. In step 301, a user can first position the medical device 100 within the patient's urethra 205. For example, the user can insert the distal end 102 of the medical device 100 into the opening of the urethra 205 and continue to advance the distal end 102 distally toward the abdomen 201. In step 301, the user can visualize the medical device 100 and (in at least some examples) the markers 135, 136 under a CT scan or x-ray scan (or other type of imaging) of the patient. In some examples, the user can insert the medical device 100 into the urethra 205 and advance the medical device 100 distally through the urethra 205 until the markers 135, 136 are adjacent to the penis bulb 203. In some examples, one marker 135, 136 can be located distal to the penis bulb 203, while one marker 135, 136 can be located proximal to the penis bulb 203. During insertion of the medical device 100 into the urethra 205 and positioning of the second balloon 105 adjacent to the penile bulbs 203, each of the first balloon 104 and the second balloon 105 can be in a deflated configuration. In some examples, before inserting the medical device 100 into the patient, the user can determine the distance from the patient's abdomen 201 to the penile bulbs 203 and position the second balloon 105 approximately the same distance from the first balloon 104 as the distance from the abdomen 201 to the penile bulbs 203. In some examples, to anchor the medical device 100 to the patient, the user can transition the first balloon 104 to an expanded configuration within the abdomen 201 to prevent the medical device 100 from moving proximally through the urethra 205. For example, the user can fill the first balloon 104 with fluid to transition the first balloon 104 to the expanded configuration.

[0032] In step 302, the user may fill the second balloon 105 with fluid to transform the second balloon 105 from a deflated configuration to an expanded configuration. Because the penis bulb 203 is adjacent to the second balloon 105, when the second balloon is expanded, the penis bulb 203 may move due to the force applied by the second balloon 105. The user may expand and deflate the second balloon 105 to change the position of the penis bulb 203. In some examples, the user may position the second balloon 105 between the radiation source and the penis bulb 203 (e.g., distal to the penis bulb 203 or at any other location) to block radiation applied by the radiation source from striking the penis bulb 203. For example, the user may position the second balloon 105 between the radiation source and the penis bulb 203, and then fill the second balloon 105 with a radiation-blocking fluid. In other words, after the balloon 105 is positioned, an imaginary line extending between the radiation source and the penis bulb may intersect the balloon 105. In step 303, the user may then administer radiation therapy to the patient, for example, by directing radiation at the prostate 213. Then, in step 304, the user may remove the medical device 100 from the patient's urethra 205.

[0033] In some examples, the medical device 100 can remain in the patient's body after the radiation treatment. For example, the patient can keep the medical device 100 in the urethra 205 during the entire treatment process, which may include multiple radiation treatment sessions. In some examples, the medical device 100 can remain in the patient's body for several days, a week, two weeks, a month, or any other period of time. If the medical device 100 is to remain in the patient's body, the second balloon 105 can be flushed (e.g., with saline or another fluid) as described above to remove residual radiation-blocking fluid and allow urine to drain from the patient's body through the medical device 100.

[0034] Various aspects of the medical device 100 (eg, the body 101 , the first balloon 104 , and the second balloon 105 ) can be low-cost and disposable (ie, a disposable device).

[0035] Medical device 100 can be used for any type of radiation therapy, such as intensity modulated radiation therapy (IMRT), external beam radiation therapy (EBRT), proton beam therapy, image guided radiation therapy (IGRT), brachytherapy, radium-223 therapy and / or stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation therapy (SABR).

[0036] In some aspects, the medical device 100 can be positioned and repositioned prior to inflation of the first balloon 104 or the second balloon 105. Such positioning and repositioning can be performed under indirect visualization, such as via CT imaging.

[0037] Figure 4A perspective view of another exemplary medical device 400 is shown, and the medical device 400 can have any of the features and attributes described above with respect to the medical device 100. The medical device 400 can include a urinary catheter, such as a modified Foley catheter. The medical device 400 can include a longitudinal body 401 including a distal end 402 and a proximal end 403. The body 401 can be tubular, having one or more central lumens extending longitudinally through the body 401. A central longitudinal axis 499 of the medical device 400 can extend through the body 401. The longitudinal body 401 can include a first longitudinal body 483 and a second longitudinal body 430, and the second longitudinal body 430 can be positioned around the first longitudinal body 483. The first longitudinal body 483 can include a distal opening 412 and a proximal opening 416, and the second longitudinal body 430 can include a proximal opening 413 and a distal opening 484. The second longitudinal body 430 can be sized to receive the first longitudinal body 483 within a central longitudinal lumen (extending from the proximal opening 413 to the distal opening 484 ) of the second longitudinal body 430 , and the first longitudinal body 483 can move proximally or distally within the second longitudinal body 430 .

[0038] In some examples, one or more additional openings 414 can be positioned circumferentially around the body 483 at the distal end 402, and the one or more additional openings 414 can be fluidly connected to the central lumen of the second longitudinal body 483. In some examples, the one or more additional openings 414, the distal opening 412, and / or the proximal opening 413 can be omitted. In such examples, the medical device 400 can be removed immediately after the procedure. For example, the medical device 400 can include one or more additional openings 414 and the proximal opening 413, but the distal opening 412 can be omitted.

[0039] The first balloon 404 can be positioned at a distal portion of the second longitudinal body 483, proximal to the distal end 402. The first balloon 404 can have any of the features of the first balloon 104 described herein, can be reversibly inflated, and can extend around the radially outer surface of the body 483 relative to the central longitudinal axis 499 of the body 483. Figure 4404 is shown in an expanded configuration and can be spherical when in an expanded configuration. When the first balloon 404 is in a deflated configuration, the first balloon 404 can be substantially flush with the radially outer surface of the second longitudinal body 483, and the first balloon 404 can be pushed through the second longitudinal body 430 when in a deflated configuration (e.g., moved proximally or distally through the central lumen of the second longitudinal body 430). The first balloon 404 can have a single chamber or a single chamber configured to receive fluid within the first balloon 404. A first independent catheter (not shown) can fluidically connect the first balloon 404 to the first valve / port 406 located at the proximal end of the body 483, and the first independent catheter can have a proximal opening 416. The first lumen of the first independent catheter can be non-fluidically connected to the central lumen of the first longitudinal body 483, and in some examples, the first independent catheter can be completely positioned within the first longitudinal body 483. In some examples, the central lumen of the first longitudinal body 483 can include multiple catheters.

[0040] When the fluid is received in the first balloon 404, the first balloon can be inflated to its fully inflated configuration (or fully expanded configuration). Using a syringe or similar instrument, a suitable volume of fluid can be injected through the first valve 406 and into the first balloon 404 through the first independent catheter.

[0041] The second balloon 405 can be coupled to the second longitudinal body 430 and positioned between the distal end 402 of the body 430 and the proximal end 443 of the body 430. The second balloon 405 can be reversibly inflated and can extend around the radially outer surface of the body 430 relative to the central longitudinal axis 499. The second balloon 405 is positioned between the distal end 402 of the body 430 and the proximal end 443 of the body 430. Figure 44. The second balloon 405 is shown in an expanded configuration and can be spherical when in the expanded configuration. The second balloon 405 can have any of the features of the second balloon 105 described herein. When the second balloon 405 is in a deflated configuration, the second balloon 405 can be substantially flush with the radially outer surface of the body 430. The second balloon 405 can have a single chamber located within the second balloon 405 that is configured to receive a fluid. A second independent conduit (not shown) can fluidically connect the second balloon 405 to a second valve / port 408 located at the proximal end 443 of the body 430, and the second independent conduit can have a proximal opening 418. The second lumen of the second independent conduit can be non-fluidically connected to the central lumen of the body 430, and in some examples, the second independent conduit can be completely positioned within the body 430. In some examples, the second independent conduit of the body 430 can include multiple conduits. In other examples, the second lumen can be positioned within a portion of the second longitudinal body 430 , such as within a wall forming a central lumen of the second longitudinal body 430 , and can be fluidly connected to the second balloon 405 and the second valve / port 408 .

[0042] Using a syringe or similar instrument, a suitable volume of fluid can be injected through the second valve 408 and through a second independent catheter into the second balloon 405. Although the second balloon 405 is shown as being located at approximately the longitudinal midpoint of the body 430, the second balloon 405 can be positioned at any portion of the body 430. In other examples, the medical device 400 can include multiple second balloons 405 positioned around the second longitudinal body 430.

[0043] The ring 447 can be coupled to the second longitudinal body 430 at a proximal portion of the second longitudinal body 430, and the ring 447 can be flush with and / or form a seal around the first longitudinal body 483. The first longitudinal body 483 can be moved distally and proximally by the ring 447 while the ring 447 maintains a seal between the ring 447 and the first longitudinal body 483. The markings 435, 436 can be positioned around the second longitudinal body 430 and can have any of the characteristics of the markings 135, 136 described herein.

[0044] Figure 5A locking device 550 including a locking buckle 551 is shown. The locking device 550 can be configured to couple to the medical device 400 and lock the medical device, specifically by wrapping the locking buckle 551 around the second longitudinal body 430 (and the first longitudinal body 483 positioned within the second longitudinal body 430) and retaining the medical device 400. The lumen 552 of the locking buckle 551 can be configured to receive the first longitudinal body 483 and the second longitudinal body 430. The locking device 550 can be configured to couple to the patient's skin, such as via an adhesive, a strap, or other coupling mechanism. The locking device 550 can allow a user to lock the medical device 400 in place and can prevent the first longitudinal body 483 from moving relative to the second longitudinal body 430 when the first longitudinal body 483 and the second longitudinal body 430 are coupled to the locking device 550 via the locking buckle 551.

[0045] During operation, the medical device 400 can allow a user to reposition the first balloon 404 and / or the second balloon 405, for example, by moving the first balloon 404 closer to or further away from the second balloon 405 while the device 400 is positioned within the patient. Because the first body 483 can move or slide through the second longitudinal body 430, the user can move the first balloon 404 proximally or distally relative to the second balloon 405 by pushing or pulling the proximal portion 491 of the first longitudinal body 483 (which is exposed on the exterior of the second longitudinal body 430). Once the user has positioned the first balloon 404 in the proper position relative to the second balloon 405 via movement of the first longitudinal body 483 relative to the second longitudinal body 430, the user can lock the medical device 400 in that position via the locking device 550, which can then be coupled to the patient or another portion of the operating room (e.g., the patient's bed, surgical tools, a control unit, etc.).

[0046] Although the principles of the present disclosure are described herein with reference to illustrative examples for specific applications, it should be understood that the present disclosure is not limited thereto. Those of ordinary skill in the art and those having access to the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents all fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the foregoing description.

Claims

1. A medical device for use during radiation therapy, the medical device comprising: a longitudinal body configured to be positioned within the urethra, wherein the longitudinal body comprises a lumen, a distal end, and a proximal end; a first balloon coupled to the distal portion of the longitudinal body and fluidly connected to a first port at the proximal end of the longitudinal body; and A second balloon is positioned between the first balloon and the proximal end of the longitudinal body and is fluidly connected to a second port at the proximal end of the longitudinal body.

2. The medical device according to claim 1, wherein The medical device is a urinary catheter.

3. The medical device of claim 1 or 2, further comprising at least one marker adjacent to the second balloon.

4. The medical device according to claim 3, wherein The at least one marker is a first marker, and the medical device further comprises a second marker; wherein the first marker is positioned on a side of the second balloon opposite to the second marker.

5. The medical device according to any one of the preceding claims, wherein In a first configuration, the second balloon is filled with barium sulfate.

6. The medical device according to any one of the preceding claims, wherein Each of the first port and the second port is configured to be coupled to a syringe.

7. The medical device according to any one of the preceding claims, wherein The second balloon is configured to transition between a fully deflated configuration and a fully expanded configuration, wherein the second balloon has a diameter between 7 mm and 12 mm in the fully expanded configuration.

8. The medical device of any preceding claim, further comprising a third balloon positioned adjacent to the second balloon.

9. The medical device of any one of the preceding claims, further comprising an opening fluidly connected to the lumen of the medical device, wherein The opening is configured to allow urine to pass therethrough.

10. A medical device for use during radiation therapy, the medical device comprising: a longitudinal body configured to be positioned within the urethra, wherein the longitudinal body comprises a lumen, a distal end, and a proximal end; a first balloon coupled to the distal portion of the longitudinal body and fluidly connected to a first port at the proximal end of the longitudinal body; wherein the first balloon is configured to be positioned within the abdomen; and A second balloon is positioned between the first balloon and the proximal end of the longitudinal body and is fluidly connected to a second port at the proximal end of the longitudinal body, wherein the second balloon is configured to be positioned adjacent to the bulb of the penis and is configured to block radiation.

11. The medical device according to claim 10, wherein: The medical device is a urinary catheter.

12. The medical device of claim 10 or 11, further comprising at least one marking adjacent to the second balloon.

13. The medical device according to claim 12, wherein: The at least one marker is a first marker, and the medical device further comprises a second marker; wherein the first marker is positioned on a side of the second balloon opposite to the second marker.

14. The medical device according to any one of claims 10 to 13, wherein: In a first configuration, the second balloon is filled with barium sulfate.

15. The medical device of any one of claims 10-14, further comprising an opening fluidly connected to the lumen of the medical device, wherein The opening is configured to allow urine to pass therethrough.

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