Radiation spacer device, delivery system, and method for preventing collateral radiation

Abstract

The radiological spacer device includes an implantable balloon and a plurality of duckbill valves. The implantable balloon defines a cavity for retaining a fluid therein. The implantable balloon has a flexible body and a neck. The neck defines an opening to the cavity. The plurality of duckbill valves are disposed within the opening, nested within each other in series and positioned relative to each other to restrict movement of the fluid out of the cavity.

Description

[Technical Field]

[0001]

[0001] The present disclosure relates generally to radiological spacer devices and delivery systems, and more particularly to devices, systems, and methods for delivering radiological spacer devices. [Background technology]

[0002] Fluid-filled balloon spacers used for implantation can suffer from leakage or other complications. For example, when pressure is applied to the balloon, the space between the target organ and adjacent organs can fluctuate. Depending on the circumstances, the balloon can deflate while the subject is still receiving treatment. Each of these scenarios can render the spacer device less effective, resulting in less effectiveness in protecting adjacent organs or the need for follow-up procedures that may result in increased complications. Summary of the Invention [Means for solving the problem]

[0003]

[0003] In one aspect, a radiological spacer device includes an implantable balloon defining a cavity for holding a fluid therein, the implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity, and a plurality of duckbill valves disposed within the opening to the cavity, the duckbill valves being nested within each other in series and positioned relative to each other to restrict movement of the fluid out of the cavity.

[0004] The radiation spacer device may also include an embodiment in which the implantable balloon is formed from a biodegradable polymer. The radiation spacer device may also include an embodiment in which the flexible body is expandable in response to an increase in the amount of fluid introduced into the cavity. The radiation spacer device may also include an embodiment in which each duckbill valve of the plurality of duckbill valves includes a base portion defining a first lumen portion and a bill portion extending distally from the base portion and defining a second lumen portion having a cross-sectional area that decreases from the first lumen portion to an outlet formed at the distal end of the duckbill valve, wherein the bill portion of the first duckbill valve extends into and is maintained within the first lumen portion of the second duckbill valve such that the bill portion of the first duckbill valve is angularly rotated relative to the bill portion of the second duckbill valve, thereby preventing leakage through the plurality of duckbill valves and restricting movement of fluid out of the cavity. The radiological spacer device may also include an embodiment in which the bill portion of the second duckbill valve is angularly rotated 90 degrees relative to the bill portion of the first duckbill valve. The radiological spacer device may also include an embodiment in which the fluid includes a biodegradable hydrogel. The radiological spacer device may also include an embodiment in which the radiological spacer device has a bioadhesive coating or physical mechanism disposed on the outer surface of the flexible body to reduce mobility of the radiological spacer within the insertion site. Other technical features will be readily apparent to those skilled in the art from the following drawings, description, and claims.

[0005] In another aspect, a radiological spacer delivery system includes a radiological spacer device including an implantable balloon defining a cavity for holding a fluid therein, the implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity, and a plurality of duckbill valves disposed within the opening to the cavity, the plurality of duckbill valves nested within each other in series and positioned relative to each other to restrict movement of the fluid out of the cavity. The radiological spacer delivery system also includes an injection assembly including an elongated member and a syringe having a chamber and a plunger, the chamber fluidly connected to the elongated member. The radiological spacer delivery system also includes a fluid delivery device including a housing having a cannula, a support member, and an actuator, and a detachment mechanism.

[0006] The radiation spacer delivery system may also include an embodiment in which each duckbill valve of the plurality of duckbill valves includes a base portion defining a first lumen portion and a bill portion extending distally from the base portion and defining a second lumen portion having a cross-sectional area that decreases from the first lumen portion to an outlet formed at the distal end of the duckbill valve, wherein the bill portion of the first duckbill valve extends into and is retained within the first lumen portion of the second duckbill valve such that the bill portion of the first duckbill valve is angularly rotated relative to the bill portion of the second duckbill valve, thereby preventing leakage through the plurality of duckbill valves and restricting movement of fluid out of the cavity. The radiation spacer delivery system may also include an embodiment in which the bill portion of the second duckbill valve is angularly rotated 90 degrees relative to the bill portion of the first duckbill valve. The radiation spacer delivery system may also include an embodiment in which the detachment mechanism includes a resistance coil. The radiation spacer delivery system may also include an embodiment in which the fluid is a biodegradable hydrogel. The radiation spacer delivery system may also include an embodiment in which the implantable balloon is a biodegradable polymer. Other technical features will be readily apparent to those skilled in the art from the following drawings, descriptions, and claims.

[0007] In one aspect, a method for protecting non-target tissue from collateral radiation includes inserting a radiation spacer device between target tissue intended to receive radiation therapy and the non-target tissue, the radiation spacer device comprising: an implantable balloon defining a cavity for retaining a fluid therein, the implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity; and a plurality of duckbill valves disposed within the opening to the cavity, the plurality of duckbill valves nested within each other in series and positioned relative to each other to restrict movement of fluid out of the cavity. The method also includes expanding the implantable balloon to create a separation between the target and non-target tissue, thereby protecting the non-target tissue from the effects of the therapy applied to the target tissue.

[0008]

[0008] The method may also include an aspect in which the target tissue is cancerous tissue and the non-target tissue is an adjacent organ. The method may also include an aspect in which the radiation spacer device is coupled to a fluid delivery device. The method may also include an aspect in which the fluid delivery device includes a housing and a detachment mechanism. The method may also include an aspect in which detaching the radiation spacer device from the fluid delivery device using the detachment mechanism. The method may also include an aspect in which the detachment mechanism is a resistive coil. The method may also include an aspect in which detaching the radiation spacer device includes thermally ablating a neck of the implantable balloon with the resistive coil. The method may also include an aspect in which expanding the implantable balloon includes filling the cavity with a fluid. The method may also include an aspect in which the fluid is a biodegradable hydrogel. The method may also include an aspect in which filling the cavity with a fluid includes passing fluid through the cavity from an injection assembly. The method may also include an embodiment in which the injection assembly includes an elongated member and a syringe including a chamber for holding a fluid and a plunger. The method may also include an embodiment in which passing the fluid from the injection assembly to the cavity includes actuation of the plunger to dispense the fluid from the chamber into the elongated member and the cavity. Other technical features may be readily apparent to those skilled in the art from the following drawings, descriptions, and claims.

[0009]

[0009] Additional features and advantages of the embodiments described in this specification will be set forth in the detailed description that follows, and in part will be readily apparent to those skilled in the art from that description, or will be learned by practice of the embodiments described in this specification, including the detailed description that follows, the claims, and the accompanying drawings.

[0010] It is to be understood that both the foregoing general description and the following detailed description are intended to describe various aspects and provide an overview and framework for understanding the nature and characteristics of the claimed subject matter. The accompanying drawings are included to provide a further understanding of the various aspects and are incorporated into and constitute a part of this specification. The drawings illustrate various aspects described herein and, together with the description, serve to explain the principles and operation of the claimed subject matter.

[0011]

[0011] The embodiments set forth in the drawings are illustrative and exemplary in nature and are not intended to limit the subject matter defined by the claims. The following detailed description of illustrative embodiments can be understood when read in conjunction with the following drawings, in which like structure is indicated with like reference numerals and in which: [Brief explanation of the drawings]

[0012] [Figure 1]

[0012] FIG. 1 is a side view of an illustrative delivery system including an injection assembly, a radiation spacer device, and a fluid delivery device according to one or more aspects shown and described herein. [Figure 2]

[0013] 2 is a perspective view of the injection needle assembly of FIG. 1 including an elongate member and a syringe according to one or more embodiments shown and described herein. FIG. [Figure 3]

[0014] 3 is a perspective view of the elongate member of FIG. 2 according to one or more embodiments shown and described herein. [Figure 4]

[0015] 2 is a perspective view of the delivery system of FIG. 1 with the injection assembly decoupled from the fluid delivery device and the radiation spacer device according to one or more embodiments shown and described herein. [Figure 5]

[0016] 2 is an exploded view of the fluid delivery device and injection assembly of FIG. 1 according to one or more embodiments shown and described herein. [Figure 6]

[0017] 2 is a perspective view of the fluid delivery device of FIG. 1 disconnected from the radiation spacer device of FIG. 1 according to one or more embodiments shown and described herein. [Figure 7]

[0018] 2 is another perspective view of the delivery system of FIG. 1 according to one or more embodiments shown and described herein. [Figure 8]

[0019] 2 is a perspective view of the delivery system of FIG. 1 with an illustrative detachment mechanism according to one or more embodiments shown and described herein. [Figure 9]

[0020] 2 is a cross-sectional view of the radiation spacer device of FIG. 1 coupled to a fluid delivery device and an illustrative detachment mechanism according to one or more embodiments shown and described herein. [Figure 10]

[0021] 2 is a perspective view of the radiation spacer device of FIG. 1 in an expanded state according to one or more embodiments shown and described herein. [Figure 11]

[0022] FIG. 11A is a perspective view of an illustrative series-nested duckbill valve according to one or more embodiments shown and described herein.

[0023] FIG. 11B is a cross-sectional view of the series-nested duckbill valves of FIG. 11A.

[0024] FIG. 11C is a perspective view of the duckbill valve of FIG. 11A in a disrupted state according to one or more embodiments shown and described herein. DETAILED DESCRIPTION OF THE INVENTION

[0013]

[0025] Reference characters indicate corresponding parts throughout the several views. The examples set forth herein illustrate at least one embodiment of the present disclosure, and such examples should not be construed as limiting the scope of the present disclosure in any way.

[0014]

[0026] The present disclosure, in one form, relates to a radiological spacer device incorporating an implantable balloon with serially nested duckbill valves for separating tissue to protect against collateral radiation, as well as systems and methods incorporating the same. The radiological spacer device described herein includes an implantable balloon defining a cavity for retaining a fluid. Additionally, the radiological spacer device described herein further includes an implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity, and a plurality of duckbill valves disposed within the opening to the cavity, the plurality of duckbill valves being serially nested within one another and positioned relative to one another to restrict movement of fluid out of the cavity.

[0015]

[0027] Furthermore, while the radiological spacer devices described herein may be implanted for the duration of a subject's treatment, additional procedures increase the risk of complications. Therefore, the devices, systems, and methods described herein include biodegradable components that can be adapted to the specific needs of a subject. As used herein, "adapted" means that the radiological spacer device is configured, shaped, and sized specifically to meet the subject's specific anatomical structure and treatment goals. "Adapted" also means that the materials forming the implantable balloon and / or fluid-filled balloon are selected or tailored for specific degradation characteristics consistent with the subject's expected treatment duration and / or needs.

[0016]

[0028] The radiation spacer devices described herein are designed so that, in an expanded state, the devices can create separation between target and non-target tissue. As used herein, the terms "separation" or "displacement" refer to filling a gap between target and non-target tissue, or to displacing target and non-target tissue such that the radiation spacer device creates and fills a gap between the tissues. This space created by the radiation spacer device protects non-target tissue from exposure or unintended side effects during treatment. The radiation spacer device can reduce adverse effects of radiation therapy, enable improved targeting, allow for higher radiation doses, and / or allow for shorter treatment times.

[0017]

[0029] Additionally, the radiation spacer devices described herein are designed to remain in an expanded state for the duration of the intended treatment. To prevent device collapse due to fluid loss or the like, the radiation spacer device can include an inflation medium that gels to prevent fluid loss and a closure that allows fluid flow in one direction but prevents reverse flow into the radiation spacer device.

[0018]

[0030] Prostate cancer is the most common non-skin cancer diagnosed in men. Radiation therapy is an excellent treatment option for prostate cancer. However, radiation exposure can cause unintended side effects in adjacent organs. Fluid-filled balloon spacers can be implanted to avoid collateral radiation and minimize damage to nearby organs by creating a space between the target organ or tissue and nearby organs or tissues at risk.

[0019]

[0031] As used herein, the term "target tissue" refers to a tissue or organ requiring radiation therapy or other treatment. As used herein, the term "non-target tissue" refers to a tissue or organ adjacent to the target tissue, where the non-target tissue is at risk of side effects from treatment of the target tissue. In some embodiments, the non-target tissue is at risk of collateral radiation.

[0020]

[0032] The devices disclosed herein may also be used in other medical procedures and treatments, including, but not limited to, vascular occlusion, punctal occlusion, duct occlusion, and other procedures and treatments requiring the occlusion of a lumen within a subject. In addition, the devices may be used in medical procedures requiring the creation of space within a subject, including, but not limited to, orbital volume augmentation, dental procedures, tissue expansion for reconstructive surgery, vocal cord procedures, etc.

[0021]

[0033] An advantage of the present disclosure is that the biodegradable components reduce the need for follow-up procedures. Additionally, the present disclosure provides a device that can be adapted to a subject's unique anatomy and treatment needs. Yet another advantage of the present disclosure is that the radiological spacer device is uniquely configured to prevent leakage, thereby allowing the created space between target and non-target tissue to be maintained.

[0022]

[0034] Referring now to the drawings, FIG. 1 shows an illustrative delivery system 100 according to various embodiments. The delivery system 100, according to one embodiment of the present disclosure, may be used in a radiological spacer device delivery procedure, whereby a radiological spacer device 30 (e.g., a balloon) is delivered to a site intended to receive radiotherapy. The delivery system 100 has a proximal end extending proximally (e.g., in the +x direction of the coordinate axes of FIG. 1 ) and a distal end extending distally (e.g., in the −x direction of the coordinate axes of FIG. 1 ). The delivery system 100 generally includes an implantable radiological spacer device 30, an injection assembly 10, and / or a fluid delivery device 20. More or fewer components may be included without departing from the scope of the present disclosure. As described herein, the various components for the delivery system 100 are connectable to one another for the purpose of delivering fluid to expand the radiological spacer device 30.

[0023]

[0035] 1, 2, 3, and 4 together, injection assembly 10 generally includes an elongate member 110 and a syringe 120. Injection assembly 10 has a distal end extending distally (e.g., in the −x direction of the coordinate axes of FIG. 1 ) and a proximal end extending proximally (e.g., in the +x direction of the coordinate axes of FIG. 1 ). In embodiments, elongate member 110 extends distally (e.g., in the −x direction of the coordinate axes of FIG. 1 ) from syringe 120.

[0024]

[0036] The elongate member 110 may be generally a hollow cylinder and may define an inflation lumen 112. The inflation lumen 112 may extend through the entire length of the elongate member 110 from an inflation port 118 disposed at the proximal end of the elongate member 110. The elongate member 110 is generally fluidly coupled to the radiological spacer device 30 to enable inflation, which will be described in more detail below.

[0025]

[0037] In embodiments, the inflation lumen 112 is configured to receive and pass an inflation fluid 122 through the radiological spacer device 30 for expansion, as described in more detail below. As used herein, the term “fluid” refers to any flowable substance capable of filling the radiological spacer device 30, such as, but not limited to, biodegradable hydrogels, saline, contrast media, injectable viscous fluids, and the like. In embodiments, the inflation fluid 122 may further include a contrast agent, such as an iodine compound, a baryta compound, a fluorocarbon, an echogenic compound, an anechoic compound, gadolinium, a radioisotope, an analgesic, a pharmaceutical, a chemotherapeutic agent, and the like. In embodiments, the inflation fluid 122 may further include a biocompatible radiation shielding material, such as, but not limited to, a polymer composite, tungsten, bismuth, antimony, and the like.

[0026]

[0038] In embodiments, inflation fluid 122 is a biodegradable hydrogel. Any suitable hydrogel material may be used. Illustrative examples of suitable hydrogel materials include, but are not limited to, albumin, polyethyleneimine (PEI), amine-containing polyethylene glycol (PEG) or proteins, and / or N-hydroxysuccinimide (NHS) ester components such as PEG-(SS)2, PEG-(SS)4, PEG-(SS)8, PEG-(SG)4, PEG-(SG)8, and the like. In some embodiments, the molecular weight of the PEG component may range from about 2,000 to about 100,000. As used herein, the terms “biodegradable” and / or “bioresorbable” refer to compounds that can be absorbed by surrounding or local tissues of a subject and / or that can be broken down and absorbed by the subject's tissues.

[0027]

[0039] Hydrogels can be composed of varying amounts of various crosslinking materials designed to allow the hydrogel to last a specific time in situ before degradation. In embodiments, hydrogel components can be selected based on a degradation time corresponding to the expected duration of radiation therapy. In embodiments, the expected duration of radiation therapy, and thus the targeted time for hydrogel degradation, can range from about 0 to about 18 months, including, for example, about 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, and 18 months, up to 18 months. It should be understood that the time is merely a rough guideline generally used to target the appropriate formulation of the hydrogel.

[0028]

[0040] The elongate member 110 may further define an outlet 114 positioned at the distal end of the elongate member 110 and coaxial with the inflation lumen 112, such that the outlet 114 is in fluid communication with the inflation lumen 112 and the radiological spacer device 30. In some embodiments, the elongate member 110 may have a pointed distal end 116.

[0029]

[0041] In some embodiments, the elongate member 110 is sized to fit within the cannula lumen 212 of the fluid delivery device 20, as shown in FIG. 4 and discussed in more detail below. While the elongate member 110 may have a circular cross-sectional shape as shown in FIGS. 1-4 , it should be understood that the elongate member 110 may have any other suitable cross-sectional shape (e.g., rectangular). The elongate member 110 may be made of any suitable material. Non-limiting examples of suitable materials include, for example, polyurethane, polyamide, polyimide, nylon, acetyl, polytetrafluoroethylene (PTFE), polypropylene, stainless steel, and the like, although any suitable material is contemplated and possible.

[0030]

[0042] As shown in FIG. 2 , syringe 120 may be in fluid communication with inflation lumen 112 of elongate member 110. In embodiments, inflation port 118 is positioned at the proximal end of elongate member 110. In embodiments, inflation port 118 fluidly connects elongate member 110 to syringe 120, as described in more detail herein. As shown in FIGS. 1 , 2 , and 4 , syringe 120 may be coupled to elongate member 110 and configured to dispense inflation fluid 122. In embodiments, syringe 120 includes chamber 124 and plunger 126. Chamber 124 may be, for example, a cylindrical tube configured to hold inflation fluid 122. Syringe 120 may also include outlet port 128 disposed at the distal end of chamber 124 and configured to dispense inflation fluid 122. In some embodiments, the distal end of plunger 126 can be positioned within chamber 124 and can be configured to dispense inflation fluid 122 from chamber 124 through outlet port 128 when plunger 126 is depressed by an operator.

[0031]

[0043] The elongate member 110 and the syringe 120 may include a connection mechanism 130. A corresponding fitting 131 may be disposed on the proximal end of the elongate member 110 and the distal end of the syringe 120. The corresponding fittings 131 may generally be shaped and sized to releasably interlock to form the connection mechanism 130. The connection mechanism 130 may be used to couple the syringe 120 to the elongate member 110. For example, in some embodiments, the syringe 120 may include a quarter-turn fitting or other fitting integrated into the distal end of the syringe 120. In some embodiments, various components of the connection mechanism 130 may be integrated into the chamber 124 such that the connection mechanism 130 and the chamber 124 are a single, unitary part. However, it should be understood that this is merely illustrative and that the various components of the connection mechanism 130 may be separate parts that are permanently or semi-permanently coupled to the syringe 120 and / or elongate member 110 (e.g., permanently or semi-permanently coupled to the distal coupling component of the syringe).

[0032]

[0044] The connector 131 disposed on the syringe 120 is generally located at the distal end of the chamber 124 such that the various components of the connector mechanism 130 are positioned adjacent to the outlet port 128. In aspects, the elongate member 110 is configured to facilitate fluid communication with the outlet port 128 to receive the inflation fluid 122 from the chamber 124 and direct the inflation fluid 122 to the outlet 114 for delivery to the radiation spacer device 30, as described in more detail below.

[0033]

[0045] In embodiments, inflation port 118 of elongate member 110 is aligned and sealed with outlet port 128 of syringe 120 when a corresponding fitting 131 is connected. Illustrative connection mechanisms include, but are not limited to, a LUER-LOCK® (Bard Peripheral Vascular, Tempe, Arizona) fitting, a LUER-SLIP® (Bard Peripheral Vascular, Tempe, Arizona) fitting, a bayonet coupling fitting, or an L-beam connector, etc. In embodiments, a flow diverter may be positioned between chamber 124 and elongate member 110 to allow for better control over the distribution of inflation fluid 122.

[0034]

[0046] 1 , 4 , 5 , and 7 , a delivery system 100 generally includes a fluid delivery device 20. The fluid delivery device 20 generally includes a housing 200 coupled to the radiation spacer device 30 and / or the injection assembly 10. In embodiments such as shown in FIG. 9 , the delivery system 100 may include a detachment mechanism 250. In embodiments, the housing 200 includes a cannula 210, a support member 220, and / or an actuator 230.

[0035]

[0047] 4 and 5 , the housing 200 of the fluid delivery device 20 may include a cannula 210. In embodiments, the cannula 210 extends distally from a support member 220. In embodiments, the distal end of the cannula 210 is coupled to the radiological spacer device 30 at an attachment point 224. In embodiments, the cannula 210 defines a cannula lumen 212. The cannula lumen 212 may have an inner diameter that is larger than the outer diameter of the elongated member 110 such that the elongated member 110 can be inserted through the cannula lumen 212 and into the radiological spacer device 30. In embodiments, the distal end of the elongated member 110 extends beyond the distal end of the cannula 210. In an embodiment, attachment point 224 is disposed within cannula lumen 212 such that the proximal end of radiological spacer device 30 is attached to the inner wall of cannula 210 .

[0036]

[0048] 4 and 5 , housing 200 may include a support member 220 configured to hold syringe 120. In embodiments, support member 220 is configured to allow insertion of elongate member 110. For example, in embodiments, support member 220 includes a distal plate 222 that defines an opening 221. In embodiments, opening 221 is aligned with cannula lumen 212 and is shaped such that elongate member 110 extends through opening 221 and into cannula lumen 212.

[0037]

[0049] The housing 200 may also generally include a handle 232 and an actuator 230 configured to dispense inflation fluid 122 from the chamber 124 of the syringe 120. As shown in Figures 1, 4, 5, and 7, the actuator 230 is coupled to the plunger 126 of the syringe 120 such that movement of the actuator 230 causes an equivalent movement of the plunger 126. Exemplary actuators include, but are not limited to, mechanical actuators, electromechanical actuators, pneumatic actuators, piezoelectric actuators, and hydraulic actuators.

[0038]

[0050] In embodiments, the actuator 230 may be configured for one-handed actuation by an operator, such as a clinician. In some embodiments, as shown in FIGS. 1, 4, and 5, the actuator 230 may be coupled to a trigger 233. The trigger 233 may be disposed on a handle 232. In embodiments, the trigger 233 is positioned for actuation while an operator holds the handle 232. In embodiments such as that shown in FIG. 5, the trigger 233 includes a gear 241 configured to move a corresponding gear 242 on the actuator 230. The actuator 230 may be any suitable mechanism for moving the plunger 126, including, but not limited to, a tension actuator handle, or the like. In other embodiments, the actuator 230 may be a hand wheel or cam that can be actuated using the operator's thumb. Any type of suitable actuator is contemplated and possible.

[0039]

[0051] As shown in FIG. 6 , in embodiments, the fluid delivery device 20 is separable from the injection assembly 10 and the radiation spacing device 30. In embodiments, a disconnector 256 disengages the actuator 230 from the trigger 233. After inflation of the radiation spacing device 30, the injection assembly 10 can be removed from the housing 200 along with the actuator 230, as shown in FIG. 4 , for example. After the radiation spacing device 30 is filled with inflation fluid 122, the radiation spacing device 30 can be disconnected from the fluid delivery device 20, as discussed in more detail below, thereby allowing the fluid delivery device 20 and / or injection assembly 10 to be removed from the body while the radiation spacing device 30 remains in place during the radiation therapy procedure. In embodiments, the fluid delivery device 20 is separable from the radiation spacing device 30 using a detachment mechanism 250. Any type of detachment mechanism known in the art is contemplated and possible. Non-limiting examples of methods and devices for separating the radiation spacer device 30 from the fluid delivery device 20 include mechanical, electrical, thermal, chemical, hydraulic, or sonic mechanisms.

[0040]

[0052] In some embodiments, the radiological spacer device 30 may be detached from the cannula 210 using mechanical means, as shown in, for example, FIGS. 8 and 9 . In embodiments, the radiological spacer device 30 may be separated from the fluid delivery device 20 by a number of mechanical methods that cut, tear, or otherwise physically disassemble a portion of the radiological spacer device 30 to separate the radiological spacer device 30 from the fluid delivery device 20. This may be accomplished by applying force against the attachment point 224. In embodiments, the detachment mechanism 250 may include a push rod 254. In embodiments, the push rod 254 has a diameter smaller than the diameter of the cannula lumen 212. After removal of the injection assembly 10, the push rod 254 may be inserted through the cannula lumen 212. The diameter of the push rod 254 may be sufficient to interact with the radiological spacer device 30 and apply sufficient force to detach the radiological spacer device 30 from the attachment point 224. This allows the operator to remove the radiation spacer device 30 after inflation and for the radiation spacer device 30 to remain within the subject.

[0041]

[0053] 9, the detachment mechanism 250 may include a resistive coil 252 communicatively coupled with electrical conductors (not shown) for severing the radiological spacer device 30 using thermal ablation. In aspects, the detachment mechanism 250 may include a release mechanism that detaches the radiological spacer device 30 from the cannula 210. In embodiments, the release mechanism may require actuation by an operator. Any suitable release mechanism is contemplated and possible, including, but not limited to, a button, a toggle, a switch, a trigger, a knob, a lever, a pedal, and the like.

[0042]

[0054] In embodiments, the detachment mechanism 250 is communicatively coupled to an electrical conductor such that actuation of the release mechanism causes an electrical current to flow. As used herein, the term "communicatively coupled" means that the coupled components can exchange data signals with each other, such as, for example, electrical signals through a conductive medium, electromagnetic signals through air, optical signals through an optical waveguide, etc.

[0043]

[0055] The resistive coil 252 may be formed using any conductive material, including, but not limited to, nickel chromium (nichrome), copper, stainless steel, titanium, zirconium, nickel titanium (nitinol), iron chromium aluminum alloys such as ALUMEL® (Concept Alloys, Inc., Whitmore Lake, Michigan), KANTHAL® (Sandvik Intellectual Property AB, Stockholm, Sweden), CHROMEL® (Concept Alloys, Inc., Whitmore Lake, Michigan), iron nickel alloys, nickel cobalt iron alloys such as KOVAR® (CRS Holdings, Inc., Delaware), and combinations or alloys thereof, although any conductive material is contemplated and possible. After expansion of the radiological spacer device 30, the clinician can activate the release mechanism to activate the electrical conductor to generate an electric current, which is passed through the resistive coil 252, causing heating and detachment of the radiological spacer device 30.

[0044]

[0056] 1-9 , the delivery system 100 generally includes a radiation spacer device 30. The radiation spacer device 30 may include an implantable balloon 300. The implantable balloon 300 may include a flexible body 302 that is configured to expand or inflate in an expanded state to define a cavity 304 configured to hold an inflation fluid 122. In an embodiment, the implantable balloon 300 may be in fluid communication with the inflation lumen 112 via a neck 306 of the implantable balloon 300.

[0045]

[0057] In embodiments, the radiological spacer device 30 is coupled to the distal end of the cannula 210. The implantable balloon 300 can be attached or engaged to the fluid delivery device 20 in a variety of ways. For example, the implantable balloon 300 can be secured to the cannula 210 by friction, with adhesives, welding, soldering, clamping, or any other attachment method known in the art. As used herein, the term "balloon" refers to any expandable device having an inflated or expanded state and a deflated state, such that in the inflated state the device has an internal volume and in the deflated state the device has substantially no internal volume. The terms deflated and collapsed, and their configurations, may be used interchangeably to refer to the implantable balloon 300 prior to filling the implantable balloon 300 with inflation fluid 122. The terms dilation and inflation, and their configurations, may be used interchangeably to refer to the act of changing the implantable balloon 300 from a deflated state to an expanded state.

[0046]

[0058] The implantable balloon 300 may be formed by any suitable means, including, but not limited to, heat treatment, extrusion blow molding, injection blow molding, solution dip coating and / or lamination of a film onto a preformed lost-wax parison, electrospinning, etc. The shape and dimensions of the implantable balloon 300 may be adaptable to fit a subject's particular anatomical structure or treatment needs. In embodiments, the implantable balloon 300 may be fabricated in any shape suitable for tissue displacement. Examples of suitable shapes include, but are not limited to, cylindrical, spherical, elliptical, pear-shaped, spindle-shaped, disc-shaped, and triangular, although other shapes are contemplated and possible.

[0047]

[0059] The implantable balloon 300 may be formed from any biocompatible material. In embodiments, the biocompatible material may be a biodegradable polymer. As discussed herein, biodegradable polymers may include polymers that are well-tolerated and / or non-reactive when contacted with the subject or the subject's immunoreactive cells, and that are susceptible to erosion and / or enzymatic degradation and / or dissolution over time within the subject or the subject's circulatory system. Biodegradable polymers allow for removal of the radiation spacer device 30 after treatment is completed, thereby eliminating the need for a removal procedure. Illustrative examples of biodegradable polymers include, but are not limited to, polymers of polylactic acid (PLA, PLLA, PDLA, PDLLA), polycaprolactone (PCL), polylactic-co-glycolic acid (PLGA), poly(ethylene glycol) methyl ether-block-poly(lactide-co-glycolide) (PLGA-b-mPEG), poly-4-hydroxybutyrate (P4HB), and combinations thereof.

[0048]

[0060] In embodiments, the material forming the implantable balloon 300 may be tailored based on the desired mechanical properties (e.g., ductility, malleability, plasticity, etc.) of the radiation spacer device 30 in vivo, as well as the intended duration of treatment. For example, a biodegradable polymer may be selected that begins to degrade at the end of the radiation treatment regimen. The degradation rate, and thus the selection of the polymer, may be determined according to the use of the radiation spacer device 30. The molecular weight, crystalline structure, and various other properties of the polymer may all be considered when determining an appropriate polymer for forming the implantable balloon 300.

[0049]

[0061] In embodiments, when inflation fluid 122 is a biodegradable hydrogel, both implantable balloon 300 and inflation fluid 122 can be formulated to begin to degrade at the end of the anticipated radiation therapy treatment. In embodiments, this is from a range of about 0 months to about 18 months, including, for example, about 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, and 18 months, up to 18 months. It should be understood that the time is merely a rough guideline generally used to target a suitable formulation of implantable balloon 300.

[0050]

[0062] Additionally, the material forming the implantable balloon 300 should be sufficiently flexible to allow for expansion of the flexible body 302. In embodiments, additives may be included in the material forming the implantable balloon 300 to enhance desired properties. For example, plasticizers such as triethyl citrate, glyceryl triacetate, acetyl triethyl citrate, polyethylene glycol 400, diethyl phthalate, tributyl citrate, acetylated monoglycerides, glycerol, fatty acid esters, propylene glycol, dibutyl phthalate, combinations thereof, and the like may be added to enhance flexibility.

[0051]

[0063] In embodiments, the implantable balloon 300 may include a bioadhesive coating or other physical features (e.g., hooks, ridges, ridges, etc.) disposed on the exterior surface of the flexible body 302 that can reduce mobility of the implantable balloon 300 within the insertion site. This feature is important for minimizing movement of the radiation spacer device 30 from the implantation site, thereby ensuring protection of non-treated tissue. As used herein, bioadhesive may refer to a natural or synthetic material that can adhere to a biological surface, such as tissue.

[0052]

[0064] In embodiments, the bioadhesive may form a continuous or discontinuous film between the radiological spacer device 30 and the biological surface. By way of example, the bioadhesive may include hydroxypropyl methylcellulose, ethyl cellulose, hydroxypropyl cellulose, polyvinylpyrimidine, polyvinyl alcohol, chitosan, polymethacrylate copolymers, silicone, polydimethylsiloxane, acrylate copolymers, octylacrylamide copolymers, octisalates, combinations thereof, and the like.

[0053]

[0065] As shown in FIG. 10 , the implantable balloon 300 generally includes a neck 306 defining an opening 308 to the cavity 304. In embodiments, the neck 306 may operably couple the distal end of the fluid delivery device 20 to the radiation spacer apparatus 30. As discussed above, a variety of attachment methods known in the art are contemplated and possible. In embodiments, the neck 306 may define the opening 308 for passage of the inflation fluid 122 into the cavity 304 of the implantable balloon 300. The distal end of the elongate member 110 extends through the cannula lumen 212 and into the opening 308, thereby fluidly connecting the inflation lumen 112 to the cavity 304.

[0054]

[0066] In embodiments, opening 308 may be in fluid communication with elongate member 110 and syringe 120 such that inflation fluid 122 may be dispensed from chamber 124 by actuation of plunger 126 and delivered to cavity 304 through inflation lumen 112 .

[0055]

[0067] In embodiments, the cavity 304 may be filled with an inflation fluid 122 to expand or distend the flexible body 302. In embodiments, the flexible body 302 is expandable in response to an increase in the amount of inflation fluid 122 introduced into the cavity 304. Expansion of the flexible body 302 occurs after the radiation spacer device 30 is inserted into a treatment site, such as between a target tissue and a non-target tissue. The radiation spacer device 30 may be inserted by any suitable insertion method (e.g., an introducer sheath) while in a contracted state. A clinician may use any suitable guidance, including, but not limited to, ultrasound guidance, a guidewire, etc., to facilitate insertion and placement of the radiation spacer device 30.

[0056]

[0068] Once positioned, expansion of the flexible body 302 may occur to create separation between adjacent tissues. In embodiments, the flexible body 302 is expanded by movement of inflation fluid 122 from the elongate member 110 through an opening 308 in the neck 306 of the implantable balloon 300 and into the cavity 304. The inflation fluid 122 allows the radiation spacer device 30, in the expanded configuration, to conform to the displaced tissue and create better separation between the target and non-target tissues. In addition to separation, the inflation fluid 122 may also act as a barrier against heat and / or radiation to further protect the non-target tissue.

[0057]

[0069] After the implantable balloon 300 is expanded, the radiation spacer device 30 is detached from the fluid delivery device 20. In embodiments, after expansion of the implantable balloon 300, the distal end of the cannula 210 is withdrawn from the neck 306 of the implantable balloon 300 to separate the fluid delivery device 20 from the radiation spacer device 30, thereby allowing the fluid delivery device 20 to be removed while leaving the radiation spacer device 30 in place in its expanded state.

[0058]

[0070] To maintain adequate spacing between target and non-target tissue, radiation spacer device 30 must maintain its volume over the expected duration of treatment. In embodiments, the expanded state is maintained by closing opening 308, thereby preventing deflation of implantable balloon 300. In embodiments, inflation fluid 122 also helps prevent deflation, such as by using a hydrogel as discussed above.

[0059]

[0071] In some embodiments, closure of the opening 308 may be achieved by a valve assembly 40 such as that shown in FIGS. 10 and 11A-11C. As used herein, the terms "check valve" and "duckbill valve" refer interchangeably to valves that allow unidirectional fluid flow while preventing reverse flow. In embodiments, one or more duckbill valves 400 such as those shown in FIGS. 11A-11C may be disposed in the neck 306 of the implantable balloon 300. In embodiments, the radiation spacer device 30 may have multiple duckbill valves 400 disposed in the neck 306 of the implantable balloon 300. In embodiments, the neck 306 of the implantable balloon 300 may be reinforced with a tubular sheath (not shown) of biodegradable material to provide protection and support to the valve assembly 40.

[0060]

[0072] In embodiments, each duckbill valve 400 has a distal end extending distally (e.g., in the −x direction of the coordinate axes of FIG. 1 ) and a proximal end extending proximally (e.g., in the +x direction of the coordinate axes of FIG. 1 ). Each duckbill valve 400 may have a base portion 402 and a bill portion 403. In embodiments, base portion 402 may have a generally circular cross-sectional shape, although other shapes are contemplated and possible. In embodiments, bill portion 403 may have a generally flattened shape compared to base portion 402. In embodiments, bill portion 403 extends distally from base portion 402.

[0061]

[0073] Duckbill valve 400 may define a lumen 412. In embodiments, lumen 412 is in fluid communication with cavity 304 and inflation lumen 112. In embodiments, a distal end of elongate member 110 is disposed within lumen 412 to allow inflation fluid 122 to expand implantable balloon 300. In embodiments, base portion 402 defines a first lumen portion 413, and bill portion 403 defines a second lumen portion 414. In embodiments, second lumen portion 414 may have a cross-sectional area that decreases from first lumen portion 413.

[0062]

[0074] The duckbill valve 400 can be configured to prevent fluid leakage from the implantable balloon 300. In embodiments, the bill section 403 defines an outlet 406 at the distal end of the duckbill valve 400. The outlet 406 can be any acceptable shape (e.g., a notch) that allows for open and closed configurations of the bill section 403. As the inflation fluid 122 passes through the duckbill valve 400, the inflation fluid 122 creates pressure on the bill section 403, holding it in the open configuration. When the flow of inflation fluid 122 is stopped, the bill section 403 returns to a flattened shape, e.g., a closed configuration. The closed configuration prevents the inflation fluid 122 from leaking out of the cavity 304. In embodiments, the duckbill valve 400 is positioned to prevent leakage when the radiation spacer device 30 is fully compressed. Such testing, including tensile and compression testing, can be performed using any suitable method known in the art, including, but not limited to, Instron testing.

[0063]

[0075] Duckbill valve 400 may be formed using a variety of conventional molding techniques known in the art (e.g., injection molding). In embodiments, duckbill valve 400 may be formed of a biodegradable polymer. In embodiments, duckbill valve 400 may be made from the same material as implantable balloon 300. Duckbill valve 400 may be made from any material that has similar degradation characteristics as implantable balloon 300. Any suitable material is contemplated and possible.

[0064]

[0076] In embodiments, multiple duckbill valves 400 can be nested in series, such as shown in FIGS. 11A and 11B, to provide a secure interlock between the valves. Note that while two series-nested duckbill valves 400 are shown, any number of additional valves is contemplated by the present disclosure. In embodiments, bill portion 403′ of first duckbill valve 400′ extends into and is retained within first lumen portion 413″ of second duckbill valve 400″. When inflation fluid 122 is dispensed from infusion assembly 10, inflation fluid 122 will cause both bill portions 403′ and 403″ to be in the open configuration.

[0065]

[0077] In an embodiment, bill portion 403' of first duckbill valve 400' is angularly rotated relative to bill portion 403'' of second duckbill valve 400''. This arrangement further restricts the movement of inflation fluid 122 out of cavity 304. In an embodiment, bill portion 403' of first duckbill valve 400' is angularly rotated relative to bill portion 403'' of second duckbill valve 400'' by any suitable angle, such as from about 15 degrees to 90 degrees, including 15 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees, and 90 degrees. In an embodiment, the angular rotation allows inflation fluid 122 to force both bill portions 403' and 403'' into an open configuration. When inflation fluid 122 ceases, bill portions 403' and 403'' return to a closed configuration.

[0066]

[0078] The plurality of duckbill valves 400 may be held in a nested position using any suitable means, including, but not limited to, adhesives, welding, etc. In embodiments, the plurality of duckbill valves 400 are formed to create a secure interlocking connection between the duckbill valves 400. As shown in Figures 11A-11C, the plurality of duckbill valves 400 may be formed with a series of protrusions 408 and grooves 410 that hold the plurality of duckbill valves 400 in a nested configuration.

[0067]

[0079] In embodiments, the valve assembly 40 remains within the radiological spacer device 30 after detachment from the fluid delivery device 20. Without a more rigid tubular support, slight strain or force on the implantable balloon 300 could open the duckbill valve 400 and allow leakage of the inflation fluid 122. However, in embodiments, the angularly rotated arrangement allows a pressure vector to open the second duckbill valve 400'' but close the first duckbill valve 400'. For example, even if the second duckbill valve 400'' fails to return to the closed configuration, allowing the reverse flow of inflation fluid 122, the pressure created by the reverse flow will reinforce the closed configuration of the first duckbill portion 403'. Furthermore, moving the radial force vector around the circumference of the duckbill valve 400 allows for a relatively constant sealing action, with multiple duckbill valves 400 alternating sealing dominance.

[0068]

[0080] The following embodiments also relate to the present disclosure.

[0081] In a first embodiment, the present disclosure relates to a radiological spacer device comprising an implantable balloon defining a cavity for holding a fluid therein, the implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity, and a plurality of duckbill valves disposed within the opening, the plurality of duckbill valves being nested within each other in series and positioned relative to each other to restrict movement of the fluid out of the cavity.

[0069]

[0082] In a second embodiment, the present disclosure relates to the radiation spacer device of the previous embodiment, wherein the implantable balloon is formed from a biodegradable polymer.

[0070]

[0083] In a third embodiment, the present disclosure relates to a radiological spacer device of any of the previous embodiments, wherein the implantable balloon is expandable in response to an increase in the amount of fluid introduced into the cavity.

[0071]

[0084] In a fourth embodiment, the present disclosure relates to a radiological spacer device of any of the previous embodiments, wherein each duckbill valve of the plurality of duckbill valves includes a base portion defining a first lumen portion and a bill portion extending distally from the base portion and defining a second lumen portion having a cross-sectional area that decreases from the first lumen portion to an outlet formed at the distal end of the duckbill valve, wherein the bill portion of the first duckbill valve extends into and is retained within the first lumen portion of the second duckbill valve such that the bill portion of the first duckbill valve is angularly rotated relative to the bill portion of the second duckbill valve, thereby preventing leakage through the plurality of duckbill valves and restricting movement of fluid out of the cavity.

[0072]

[0085] In a fifth embodiment, the present disclosure relates to a radiation spacer device of any of the previous embodiments, wherein the bill portion of the second duckbill valve is angularly rotated by 90 degrees relative to the bill portion of the first duckbill valve.

[0073]

[0086] In a sixth embodiment, the present disclosure relates to the radiation spacer device of any of the previous embodiments, wherein the fluid comprises a biodegradable hydrogel. The fluid may also include a contrast agent, a biocompatible radiation shielding material, a pharmaceutical agent, a chemotherapeutic agent, and / or combinations thereof.

[0074]

[0087] In a seventh embodiment, the present disclosure relates to a radiological spacer device of any of the previous embodiments, having a bioadhesive coating or physical mechanism disposed on the outer surface of the flexible body to reduce mobility of the radiological spacer within the insertion site.

[0075]

[0088] In an eighth embodiment, the present disclosure relates to a radiological spacer delivery system comprising: an implantable balloon defining a cavity for holding a fluid therein, the implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity; a radiological spacer device including a plurality of duckbill valves disposed within the opening to the cavity, the duckbill valves being nested within each other in series and positioned relative to each other to restrict movement of fluid out of the cavity; an injection assembly including an elongated member and a syringe having a chamber and a plunger, the chamber fluidly connected to the elongated member; and a fluid delivery device including a housing having a cannula, a support member, and an actuator, and a detachment mechanism.

[0076]

[0089] In a ninth embodiment, the present disclosure relates to the radiation spacer delivery system of the previous embodiment, wherein the radiation spacer device is any of the first to seventh embodiments.

[0077]

[0090] In a tenth embodiment, the present disclosure relates to a radiation delivery system of any of the previous embodiments, wherein a radiation spacer device is positioned at a distal end of the radiation delivery system, optionally attached to a fluid delivery device, such as inside a cannula.

[0078]

[0091] In an eleventh embodiment, the present disclosure relates to a radiation delivery system of any of the previous embodiments, wherein the elongate member is positioned proximal to the radiation spacer device.

[0079]

[0092] In a twelfth embodiment, the present disclosure relates to a radiation delivery system of any of the previous embodiments, wherein the elongate member is positioned distal to the syringe.

[0080]

[0093] In a thirteenth embodiment, the present disclosure relates to a radiation delivery system of any of the previous embodiments, wherein the actuator is coupled to a trigger via a corresponding gear such that depression of the trigger by an operator causes the actuator to depress the plunger.

[0081]

[0094] In a fourteenth embodiment, the present disclosure relates to a radiation delivery system of any of the previous embodiments, wherein each duckbill valve of the plurality of duckbill valves includes a base portion defining a first lumen portion and a bill portion extending distally from the base portion and defining a second lumen portion having a cross-sectional area that decreases from the first lumen portion to an outlet formed at the distal end of the duckbill valve, wherein the bill portion of the first duckbill valve extends into and is held within the first lumen portion of the second duckbill valve such that the bill portion of the first duckbill valve is angularly rotated relative to the bill portion of the second duckbill valve, thereby preventing leakage through the plurality of duckbill valves and restricting movement of fluid out of the cavity.

[0082]

[0095] In a fifteenth embodiment, the present disclosure relates to a radiation delivery system of any of the previous embodiments, wherein the bill portion of the second duckbill valve is angularly rotated by 90 degrees relative to the bill portion of the first duckbill valve.

[0083]

[0096] In a sixteenth embodiment, the present disclosure relates to the radiation delivery system of any of the previous embodiments, wherein the detachment mechanism includes a resistive coil. The resistive coil may optionally be disposed within a cannula of the fluid delivery device. Additionally, the resistive coil may be disposed at the distal end of the cannula so as to be located near the attachment point of the radiation spacer device to the cannula. The resistive coil may detach the radiation spacer device by thermally ablating the neck of the implantable balloon with the resistive coil.

[0084]

[0097] In a seventeenth embodiment, the present disclosure relates to a radiation delivery system of any of the previous embodiments, wherein the fluid is a biodegradable hydrogel.

[0098] In an eighteenth embodiment, the present disclosure relates to a radiation delivery system of any of the previous embodiments, wherein the implantable balloon is a biodegradable polymer.

[0085]

[0099] In a nineteenth embodiment, the present disclosure relates to the use in a patient of a radiation spacer device or a radiation delivery system of any of the previous embodiments.

[0100] In a twentieth embodiment, the present disclosure relates to a method for protecting non-target tissue from collateral radiation, the method comprising the steps of inserting a radiation spacer device between a target tissue intended to receive radiation therapy and the non-target tissue, the radiation spacer device comprising: an implantable balloon defining a cavity for holding a fluid therein, the implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity; and a plurality of duckbill valves disposed within the opening to the cavity, the duckbill valves being nested within each other in series and positioned relative to each other to restrict movement of fluid out of the cavity; and expanding the implantable balloon to create separation between the target tissue and the non-target tissue, thereby protecting the non-target tissue from collateral radiation.

[0086]

[0101] In a twenty-first embodiment, the present disclosure relates to the method of any of the previous embodiments, wherein the target tissue is cancer tissue and the non-target tissue is an adjacent organ.

[0102] In a twenty-second embodiment, the present disclosure relates to the method of any of the previous embodiments, wherein the radiological spacer device is coupled to a fluid delivery device.

[0087]

[0103] In a twenty-third embodiment, the present disclosure relates to the method of any of the previous embodiments, wherein the fluid delivery device comprises a housing and a detachment mechanism.

[0104] In a twenty-fourth embodiment, the present disclosure relates to the method of any of the previous embodiments, further comprising the step of detaching the radiological spacer device from the fluid delivery device using a detachment mechanism.

[0088]

[0105] In a twenty-fifth embodiment, the present disclosure relates to the method of any of the previous embodiments, wherein the detachment mechanism is a resistive coil.

[0106] In a twenty-sixth embodiment, the present disclosure relates to the method of any of the previous embodiments, wherein the step of detaching the radiation spacer device includes the step of thermally ablating the neck of the implantable balloon with a resistive coil.

[0089]

[0107] In a twenty-seventh embodiment, the present disclosure relates to the method of any of the previous embodiments, wherein expanding the implantable balloon includes filling the cavity with a fluid.

[0090]

[0108] In a twenty-eighth embodiment, the present disclosure relates to the method of any of the previous embodiments, wherein the fluid is a biodegradable hydrogel.

[0109] In a twenty-ninth embodiment, the present disclosure relates to the method of any of the previous embodiments, wherein filling the cavity with fluid includes passing fluid from the injection assembly through the cavity.

[0091]

[0110] In a thirtieth embodiment, the present disclosure relates to the method of any of the previous embodiments, wherein the injection assembly comprises an elongate member and a syringe including a chamber for holding a fluid and a plunger.

[0092]

[0111] In a thirty-first embodiment, the present disclosure relates to the method of any of the previous embodiments, wherein the step of passing fluid from the injection assembly to the cavity includes actuating a plunger to dispense fluid from the chamber into the elongate member and the cavity.

[0093]

[0112] In a thirty-second embodiment, the present disclosure relates to a use of the radiation spacer device and / or radiation delivery system of any of the previous embodiments for protecting non-target tissue from collateral radiation, the use comprising the steps of inserting the radiation spacer device between target tissue intended to receive radiation therapy and the non-target tissue, the radiation spacer device comprising: an implantable balloon defining a cavity for holding a fluid therein, the implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity; and a plurality of duckbill valves disposed within the opening to the cavity, the plurality of duckbill valves being nested in series within each other and positioned relative to each other to restrict movement of fluid out of the cavity; and expanding the implantable balloon to create separation between the target tissue and the non-target tissue, thereby protecting the non-target tissue from collateral radiation.

[0094]

[0113] In a thirty-third embodiment, the present disclosure relates to the use of any of the previous embodiments, wherein the target tissue is cancer tissue and the non-target tissue is an adjacent organ.

[0114] In a thirty-fourth embodiment, the present disclosure relates to the use of any of the previous embodiments, wherein the radiological spacer device is coupled to a fluid delivery device.

[0095]

[0115] In a thirty-fifth embodiment, the present disclosure relates to the use of any of the previous embodiments, wherein the fluid delivery device comprises a housing and a detachment mechanism.

[0116] In a thirty-sixth embodiment, the present disclosure relates to the use of any of the previous embodiments, further comprising the step of detaching the radiological spacer device from the fluid delivery device using a detachment mechanism.

[0096]

[0117] In a thirty-seventh embodiment, the present disclosure relates to the use of any of the previous embodiments, wherein the detachment mechanism is a resistive coil.

[0118] In a thirty-eighth embodiment, the present disclosure relates to the use of any of the previous embodiments, wherein the step of detaching the radiation spacer device includes a step of thermally ablating the neck of the implantable balloon with a resistive coil.

[0097]

[0119] In a thirty-ninth embodiment, the present disclosure relates to the use of any of the previous embodiments, wherein expanding the implantable balloon includes filling the cavity with a fluid.

[0098]

[0120] In a fortieth embodiment, the present disclosure relates to the use of any of the previous embodiments, wherein the fluid is a biodegradable hydrogel.

[0121] In a forty-first embodiment, the present disclosure relates to the use of any of the previous embodiments, wherein the step of filling the cavity with fluid includes passing fluid from the injection assembly through the cavity.

[0099]

[0122] In a forty-second embodiment, the present disclosure relates to the use of any of the previous embodiments, wherein the injection assembly comprises an elongated member and a syringe including a chamber for holding a fluid and a plunger.

[0100]

[0123] In a forty-third embodiment, the present disclosure relates to the use of any of the previous embodiments, wherein the step of passing fluid from the injection assembly to the cavity includes actuating a plunger to dispense fluid from the chamber into the elongated member and the cavity.

[0101]

[0124] Any embodiment can be used in combination with any other embodiment or stand alone from any other embodiment.

[0125] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

1. an implantable balloon defining a cavity for holding a fluid therein, the implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity; a plurality of duckbill valves disposed within the opening, the duckbill valves being nested within one another in series and positioned relative to one another to restrict movement of the fluid out of the cavity; A radiation spacer device comprising:

2. 2. The radiation spacer device according to claim 1, A radiation spacer device, wherein the implantable balloon is formed from a biodegradable polymer.

3. 2. The radiation spacer device according to claim 1, The implantable balloon is expandable in response to an increase in the amount of fluid introduced into the cavity.

4. 2. The radiation spacer device according to claim 1, Each duckbill valve of the plurality of duckbill valves is a base portion defining a first lumen portion; a bill portion extending distally from the base portion and defining a second lumen portion having a cross-sectional area that decreases from the first lumen portion to an outlet formed at the distal end of the duckbill valve; Including, the bill portion of a first duckbill valve extends into and is maintained within the first lumen portion of the second duckbill valve such that the bill portion of the first duckbill valve is angularly rotated relative to the bill portion of the second duckbill valve, thereby preventing leakage through the plurality of duckbill valves and restricting the movement of the fluid out of the cavity; Radiation spacer device.

5. 5. The radiation spacer device according to claim 4, A radiation spacer device, wherein the bill portion of the second duckbill valve is angularly rotated by 90 degrees relative to the bill portion of the first duckbill valve.

6. 2. The radiation spacer device according to claim 1, A radiation spacer device, wherein the fluid comprises a biodegradable hydrogel.

7. 2. The radiation spacer device according to claim 1, A radiological spacer device having a bioadhesive coating or physical mechanism disposed on an exterior surface of the flexible body for reducing mobility of the radiological spacer device within an insertion site.

8. an implantable balloon defining a cavity for holding a fluid therein, the implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity; a plurality of duckbill valves disposed within the opening to the cavity, the duckbill valves being nested within one another in series and positioned relative to one another to restrict movement of the fluid out of the cavity; a radiation spacer device including: an elongated member; a syringe having a chamber and a plunger, the chamber being fluidly connected to the elongated member; an injection assembly including: a housing having a cannula, a support member, and an actuator; and a release mechanism. a fluid delivery device comprising: A radiation spacer delivery system comprising:

9. 9. The radiation spacer delivery system of claim 8, Each duckbill valve of the plurality of duckbill valves is a base portion defining a first lumen portion; a bill portion extending distally from the base portion and defining a second lumen portion having a cross-sectional area that decreases from the first lumen portion to an outlet formed at the distal end of the duckbill valve; Including, the bill portion of a first duckbill valve extends into and is maintained within the first lumen portion of the second duckbill valve such that the bill portion of the first duckbill valve is angularly rotated relative to the bill portion of the second duckbill valve, thereby preventing leakage through the plurality of duckbill valves and restricting the movement of the fluid out of the cavity; Radiation spacer delivery system.

10. 10. The radiation spacer delivery system of claim 9, A radiation spacer delivery system, wherein the bill portion of the second duckbill valve is angularly rotated by 90 degrees relative to the bill portion of the first duckbill valve.

11. 9. The radiation spacer delivery system of claim 8, The radiation spacer delivery system, wherein the detachment mechanism includes a resistive coil.

12. 9. The radiation spacer delivery system of claim 8, A radiation spacer delivery system, wherein the fluid is a biodegradable hydrogel.

13. 9. The radiation spacer delivery system of claim 8, A radiation spacer delivery system, wherein the implantable balloon is made of a biodegradable polymer.

14. 1. A method for protecting non-target tissue from collateral radiation, comprising: inserting a radiation spacer device between a target tissue intended to receive radiation therapy and the non-target tissue, the radiation spacer device comprising: an implantable balloon defining a cavity for holding a fluid therein, the implantable balloon having a flexible body and a neck, the neck defining an opening to the cavity; a plurality of duckbill valves disposed within the opening to the cavity, the duckbill valves being nested within one another in series and positioned relative to one another to restrict movement of the fluid out of the cavity; and expanding the implantable balloon to create separation between the target tissue and the non-target tissue, thereby protecting the non-target tissue from collateral radiation; A method comprising:

15. 15. The method of claim 14, The method, wherein the target tissue is cancer tissue and the non-target tissue is an adjacent organ.

16. 15. The method of claim 14, The method wherein the radiological spacer device is coupled to a fluid delivery device.

17. 17. The method of claim 16, The method, wherein the fluid delivery device comprises a housing and a detachment mechanism.

18. 18. The method of claim 17, The method further comprising detaching the radiation spacer device from the fluid delivery device using the detachment mechanism.

19. 20. The method of claim 18, The method wherein the detachment mechanism is a resistive coil.

20. 20. The method of claim 19, The method, wherein detaching the radiation spacer device comprises thermally ablating the neck of the implantable balloon with the resistive coil.

21. 15. The method of claim 14, The method, wherein expanding the implantable balloon comprises filling the cavity with the fluid.

22. 22. The method of claim 21, The method wherein the fluid is a biodegradable hydrogel.

23. 23. The method of claim 22, The method, wherein filling the cavity with the fluid comprises passing the fluid from an injection assembly into the cavity.

24. 24. The method of claim 23, The method, wherein the injection assembly comprises an elongate member and a syringe including a chamber for holding the fluid and a plunger.

25. 25. The method of claim 24, The method, wherein passing the fluid from the injection assembly through the cavity includes actuating a plunger to dispense the fluid from the chamber into the elongate member and the cavity.

Images