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

Abstract

A radiation spacer device includes an implantable balloon and a plurality of duckbill valves. The implantable balloon defines a lumen for holding a fluid therein. The implantable balloon has a flexible body and a neck. The neck defines an aperture into the cavity. A plurality of duckbill valves are disposed within the orifice and nested in series within one another and arranged relative to one another to limit fluid movement out of the cavity.

Description

Technical Field

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

[0002] Fluid-filled balloon spacers for implantation may be subject to leakage or other complications. For example, when pressure is applied to the balloon, the spacing between the target organ and adjacent organs may fluctuate. In some cases, the balloon may deflate while the subject is still receiving treatment. Each of these situations may render the spacer device less effective, resulting in less effectiveness in protecting adjacent organs, or requiring subsequent procedures that may result in increased complications. Summary of the invention

[0003] In one aspect, a radiation spacer device includes: an implantable balloon defining a cavity for retaining a fluid therein, the implantable balloon having a flexible body and a neck defining an opening into the cavity; and a plurality of duckbill valves disposed within the opening into the cavity, wherein the plurality of duckbill valves are nested in series with one another and are arranged relative to one another to limit fluid movement out of the cavity.

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

[0005] In another aspect, a radiation spacer delivery system includes a radiation spacer device, the radiation 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 into the cavity; and a plurality of duckbill valves disposed within the opening into the cavity, wherein the plurality of duckbill valves are nested in series within each other and arranged relative to each other to limit fluid movement out of the cavity. The radiation spacer delivery system also includes an injection assembly, the injection assembly including a slender member, and the syringe includes a chamber and a plunger, wherein the chamber fluid is coupled to the slender member. The radiation spacer delivery system also includes a fluid delivery device, the fluid delivery device including a housing, the housing including a sleeve, a support member and an actuator, and a disengagement mechanism.

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

[0007] In one aspect, a method of protecting against incidental radiation of non-targeted tissue is provided, the method comprising inserting a radiation spacer device between a targeted tissue intended to receive radiation therapy and a non-targeted tissue, wherein the radiation spacer device comprises: 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 into the cavity; and a plurality of duckbill valves disposed within the opening into the cavity, wherein the plurality of duckbill valves are nested in series within each other and arranged relative to each other to restrict fluid from moving out of the cavity. The method also comprises expanding the implantable balloon to create a separation between the targeted tissue and the non-targeted tissue, thereby protecting the non-targeted tissue from the effects of the therapy applied to the targeted tissue.

[0008] The method may also include an aspect in which the targeted tissue is cancerous tissue and the non-targeted 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 disengagement mechanism. The method may also include disengaging the radiation spacer device from the fluid delivery device using the disengagement mechanism. The method may also include an aspect in which the disengagement mechanism is a resistive coil. The method may also include an aspect in which disengaging the radiation spacer device includes thermally ablating the 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 transferring the fluid from an injection assembly to the cavity. The method may also include an aspect in which the injection assembly includes an elongated member and a syringe, the syringe including a chamber for holding the fluid and a plunger. The method may also include an aspect in which transferring the fluid from the injection assembly to the cavity includes actuating the plunger to distribute the fluid from the chamber into the elongated member and into the cavity. Other technical features will be apparent to those skilled in the art from the following drawings, description and claims.

[0009] Additional features and advantages of the aspects described herein will be set forth in the following detailed description, and in part will be apparent to those skilled in the art from that description or may be learned by practicing the aspects described herein, including the following detailed description, claims, and accompanying drawings.

[0010] It should be understood that both the foregoing general description and the following detailed description describe various aspects and are intended to provide an overview or framework for understanding the nature and character 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 accompanying drawings illustrate various aspects described herein and, together with the description, serve to explain the principles and operation of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The embodiments illustrated 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 the illustrative embodiments can be understood when read in conjunction with the following drawings, in which like structures are indicated by like reference numerals, and in which:

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

[0013] Figure 2 Depicted are embodiments according to one or more aspects shown and described herein. Figure 1 A perspective view of an injection needle assembly comprising an elongated member and a syringe;

[0014] Figure 3 Depicted are embodiments according to one or more aspects shown and described herein. Figure 2 A perspective view of an elongated member;

[0015] Figure 4 Depicted are embodiments according to one or more aspects shown and described herein. Figure 1 A perspective view of a delivery system of wherein the injection assembly is disconnected from the fluid delivery device and the radiation spacer device;

[0016] Figure 5 Depicted are embodiments according to one or more aspects shown and described herein. Figure 1 An exploded view of a fluid delivery device and an injection assembly;

[0017] Figure 6 Depicted are embodiments of the present invention in accordance with one or more aspects shown and described herein. Figure 1 The radiating spacer device disconnects the Figure 1 A perspective view of a fluid delivery device;

[0018] Figure 7 Depicted are embodiments according to one or more aspects shown and described herein. Figure 1 Alternative perspectives of the delivery system;

[0019] Figure 8 Depicted is a schematic diagram of a device having an illustrative release mechanism according to one or more aspects shown and described herein. Figure 1 A perspective view of a delivery system;

[0020] Fig. 9 Depicts a device coupled to a fluid delivery device and an illustrative disengagement mechanism according to one or more aspects shown and described herein. Figure 1 A cross-sectional view of a radiation spacer device;

[0021] Fig.10 Depicts an expanded state according to one or more aspects shown and described herein. Figure 1 A perspective view of a radiation spacer device;

[0022] Fig.11A depicts a perspective view of an illustrative tandem nested duckbill valve according to one or more aspects shown and described herein;

[0023] Fig. 11B Depicted Fig.11A A cross-sectional view of a series nested duckbill valve; and

[0024] Fig. 11CDepicts a disconnected state according to one or more aspects shown and described herein. Fig.11A Perspective view of a duckbill valve.

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

[0026] The present disclosure relates, in one form, to a radiation spacer device incorporating an implantable balloon having duckbill valves nested in series for separating tissue to protect against incidental radiation, and also to systems and methods incorporating the implantable balloon. The radiation spacer device described herein includes an implantable balloon that defines a cavity for retaining a fluid. In addition, the radiation spacer device described herein also includes: an implantable balloon having a flexible body and a neck that defines an opening into the cavity; and a plurality of duckbill valves disposed within the opening into the cavity, wherein the plurality of duckbill valves are nested in series with each other and arranged relative to each other to restrict the movement of fluid out of the cavity.

[0027] In addition, the radiation spacer device described herein can be implanted for the length of time that the subject's treatment lasts, but additional procedures increase the risk of complications. Therefore, the devices, systems and methods described herein include biodegradable components that can adapt to the specific needs of the subject. As used herein, "adaptation" means that the radiation spacer device is specially configured, shaped and sized to meet the specific anatomical and therapeutic goals of the subject. "Adaptation" also means that the material forming the implantable balloon and / or the fluid filling the balloon are selected for a specific degradation curve consistent with the expected treatment length and / or needs of the subject or adjusted according to a specific degradation curve consistent with the expected treatment length and / or needs of the subject.

[0028] The radiation spacer device disclosed herein is designed so that in the expanded state, the device is able to create a separation between the targeted tissue and the non-targeted tissue. As used herein, the term "separation" or "displacement" refers to filling the gap between the targeted tissue and the non-targeted tissue or moving the targeted tissue and the non-targeted tissue so that the radiation spacer device creates and fills the gap between the tissues. The space created by the radiation spacer device protects the non-targeted tissue from exposure or unplanned side effects during treatment. The radiation spacer device can reduce the harmful effects of radiation therapy, allow improved targeting, allow higher doses of radiation, and / or allow shorter treatment times.

[0029] In addition, the radiation spacer devices disclosed herein are designed to maintain an expanded state for the intended length of treatment. To prevent deflation of the device, such as by fluid loss, the radiation spacer device can include an inflation medium that gels to prevent fluid loss, and a closure that allows one-way flow into the radiation spacer device but prevents backflow.

[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 nearby organs. Fluid-filled balloon spacers can be implanted to avoid incidental radiation and minimize damage to nearby organs by providing space between the target organ or tissue and nearby organs or tissues at risk.

[0031] As used herein, the term "targeted tissue" refers to a tissue or organ that requires radiation therapy or other treatment. As used herein, the term "non-targeted tissue" refers to a tissue or organ adjacent to a targeted tissue, wherein the non-targeted tissue is at risk of side effects of treating the targeted tissue. In some embodiments, the non-targeted tissue is at risk of incidental radiation.

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

[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 customized according to the unique anatomical structure and treatment needs of the subject. In addition, another advantage of the present disclosure is that the radiation spacer device is uniquely configured to prevent leakage, thereby allowing the space created between the targeted tissue and the non-targeted tissue to be maintained.

[0034] Turning now to the accompanying drawings, Figure 1 An illustrative delivery system 100 is depicted in accordance with various aspects. According to one aspect of the invention, the delivery system 100 can be used in a radiation spacer device delivery procedure, whereby a radiation spacer device 30 (e.g., a balloon) is delivered to a site intended to receive radiation therapy. The delivery system 100 has a proximal extension (e.g., at Figure 1 The proximal end of the coordinate axis of the +x direction) and the distal end extending (for example, in the Figure 1The delivery system 100 generally includes an implantable radiation spacer device 30, an injection assembly 10, and / or a fluid delivery device 20. A greater or lesser number of components may be included without departing from the scope of the present disclosure. As described herein, the various components for the delivery system 100 may be coupled together for delivering fluid to expand the radiation spacer device 30.

[0035] Common Reference Figure 1 , Figure 2 , Figure 3 and Figure 4 , the injection assembly 10 generally includes a slender member 110 and a syringe 120. The injection assembly 10 has a distal end (e.g., Figure 1 The distal end extending in the -x direction of the coordinate axis of the Figure 1 In various aspects, the elongated member 110 extends distally from the syringe 120 (e.g., in the +x direction of the coordinate axis of the syringe). Figure 1 The coordinate axis extends in the -x direction.

[0036] The elongated member 110 may be generally hollow cylindrical and may define an inflation lumen 112. The inflation lumen 112 may extend through the length of the elongated member 110 from an inflation port 118 disposed at the proximal end of the elongated member 110. The elongated member 110 is generally fluidly coupled to the radiation spacer device 30 to enable inflation, as will be described in greater detail below.

[0037] In various aspects, the inflation lumen 112 is configured to receive an inflation fluid 122 and deliver the inflation fluid 122 into the radiation spacer device 30 for expansion, as described in more detail below. As used herein, the term "fluid" refers to any flowable substance having the ability to fill the radiation spacer device 30, such as, but not limited to, biodegradable hydrogels, saline, contrast media, injectable viscous fluids, and the like. In various aspects, the inflation fluid 122 may also include contrast agents, such as iodinated compounds, barium compounds, fluorocarbon compounds, echogenic compounds, anesthetic compounds, gadolinium, radioisotopes, analgesics, drugs, chemotherapeutic agents, and the like. In various aspects, the inflation fluid 122 may also include biocompatible radiation shielding materials, including, but not limited to, polymer composites, tungsten, bismuth, antimony, and the like.

[0038] In various aspects, the 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 protein, N-hydroxysuccinimide (NHS) ester components, such as PEG-(SS)2, PEG-(SS)4, PEG-(SS)8, PEG-(SG)4, PEG-(SG)8, and / or the like. In some aspects, the molecular weight of the PEG component may be in the range of from about 2,000 to about 100,000. As used herein, "biodegradable" and / or "bioabsorbable" refers to a compound that can be absorbed by the surrounding or local tissues of a subject and / or degraded and absorbed by the tissues of a subject.

[0039] Hydrogel can be made up of various cross-linked substances of different amounts, designed to allow hydrogel to last specific time amount in situ before degradation. In various aspects, hydrogel components can be selected based on the degradation time corresponding to the length of expected radiation therapy. In various aspects, the length of expected radiation therapy and therefore the targeting time of hydrogel degradation is up to 18 months, for example, from about 0 month to about 18 months, including 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. It should be understood that time is only a rough guide for the appropriate formulation of targeted hydrogels.

[0040] Elongate member 110 can also define an outlet 114 positioned at the distal end of elongate member 110 and coaxial with inflation lumen 112 such that outlet 114 is in fluid communication with inflation lumen 112 and radiating spacer device 30. In some aspects, elongate member 110 can have a pointed distal end 116.

[0041] In some aspects, the elongate member 110 is sized to fit within the cannula lumen 212 of the fluid delivery device 20, such as Figure 4 and discussed in more detail below. Figures 1 to 4 As shown in , the elongated member 110 can have a circular cross-sectional shape, but it should be understood that the elongated member 110 can have any other suitable cross-sectional shape (e.g., rectangular). The elongated member 110 can 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.

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

[0043] The elongated member 110 and the syringe 120 may include a connection mechanism 130. Corresponding connectors 131 may be provided on the proximal end of the elongated member 110 and the distal end of the syringe 120. The shape and size of the corresponding connectors 131 may generally be designed to releasably interlock, thereby forming the connection mechanism 130. The connection mechanism 130 may be used to couple the syringe 120 to the elongated member 110. For example, in some aspects, the syringe 120 may include a quarter-turn connector or other connector integrated with the distal end of the syringe 120. In some aspects, the various components of the connection mechanism 130 are integrated with the chamber 124 so that the connection mechanism 130 and the chamber 124 are a single integral piece. However, it should be understood that this is merely illustrative, and the various components of the connection mechanism 130 may be separate pieces that are permanently or semi-permanently coupled to the syringe 120 and / or the elongated member 110 (e.g., permanently or semi-permanently coupled to the distal coupling of the syringe).

[0044] A 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 connection mechanism 130 are located adjacent the outlet port 128. In various aspects, the elongated 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 into the radiation spacer device 30, as described in more detail below.

[0045] In various aspects, the inflation port 118 of the elongated member 110 is aligned and sealed with the outlet port 128 of the syringe 120 when the corresponding connector 131 is connected. Illustrative connection mechanisms include, but are not limited to, a LUER-LOCK® (Bard Peripheral Vascular, Tempe AZ) connector, a LUER-SLIP® (Bard Peripheral Vascular, Tempe AZ) connector, a bayonet coupling connector, an L-beam coupling member, or the like. In various aspects, a flow switch can be positioned between the chamber 124 and the elongated member 110 to allow for better control of the dispersion of the inflation fluid 122.

[0046] Reference now Figure 1 , Figure 4 , Figure 5 and Figure 7 , the delivery system 100 generally includes a fluid delivery device 20. The fluid delivery device 20 generally includes a housing 200 coupled to a radiation spacer device 30 and / or an injection assembly 10. In various aspects, such as Fig. 9 As shown in , the delivery system 100 can include a disengagement mechanism 250. In various aspects, the housing 200 includes a cannula 210, a support member 220, and / or an actuator 230.

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

[0048] Still reference Figure 4 and Figure 5 , the housing 200 can include a support member 220 configured to hold the syringe 120. In various aspects, the support member 220 is configured to allow insertion of the elongated member 110. For example, in various aspects, the support member 220 includes a distal plate 222 defining an opening 221. In various aspects, the opening 221 is aligned with the cannula lumen 212 and is shaped such that the elongated member 110 extends through the opening 221 and into the cannula lumen 212.

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

[0050] In various aspects, the actuator 230 can be configured for single-handed actuation by an operator (such as a clinician). Figure 1 , Figure 4 and Figure 5 As depicted in FIG. 2 , the actuator 230 can be coupled to a trigger 233. The trigger 233 can be disposed on the handle 232. In various aspects, the trigger 233 is positioned for actuation when the operator holds the handle 232. In various aspects, such as Figure 5 , the trigger 233 includes a gear 241 that is configured to move a corresponding gear 242 of the actuator 230. The actuator 230 can be any suitable mechanism for moving the plunger 126, including but not limited to a tension actuator handle and the like. In other aspects, the actuator 230 can be a hand wheel or cam that can be actuated using the operator's thumb. Any type of suitable actuator is contemplated and possible.

[0051] like Figure 6 As shown in FIG. 1 , in various aspects, the fluid delivery device 20 can be separated from the injection assembly 10 and the radiation spacer device 30. In various aspects, the disconnector 256 disengages the actuator 230 from the trigger 233. After the radiation spacer device 30 is inflated, the injection assembly 10 can be removed from the housing 200 along with the actuator 230, as shown in FIG. Figure 4 . After the radiation spacer device 30 has been filled with the inflation fluid 122, as discussed in further detail below, the radiation spacer device 30 can be disconnected from the fluid delivery device 20, thereby allowing the radiation spacer device 30 to remain in place during radiation therapy while the fluid delivery device 20 and / or injection assembly 10 are removed from the body. In various aspects, the fluid delivery device 20 can be separated from the radiation spacer device 30 using a disengagement mechanism 250. Any type of disengagement 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.

[0052] In some aspects, such as Figure 8 and Fig. 9 , the radiation spacer device 30 can be detached from the cannula 210 using mechanical means. In various aspects, the radiation spacer device 30 can be separated from the fluid delivery device 20 by a variety of mechanical methods, which cut, tear or otherwise physically degrade a portion of the radiation spacer device 30 to separate the radiation spacer device 30 from the fluid delivery device 20. This can be achieved by applying a force to the attachment point 224. In various aspects, the detachment mechanism 250 may include a push rod 254. In various aspects, the diameter of the push rod 254 is less than the diameter of the cannula lumen 212. After removing the injection assembly 10, the push rod 254 can be inserted through the cannula lumen 212. The diameter of the push rod 254 can be sufficient to interact with the radiation spacer device 30 and apply a force sufficient to detach the radiation spacer device 30 from the attachment point 224. This allows the operator to remove the radiation spacer device 30 after inflation and allow it to remain in the subject.

[0053] like Fig. 9 As shown in , the disengagement mechanism 250 may include a resistive coil 252 that is communicatively coupled to an electrical conductor (not shown) to disconnect the radiation spacer device 30 using thermal ablation. In various aspects, the disengagement mechanism 250 may include a release mechanism that disengages the radiation spacer device 30 from the cannula 210. In embodiments, the release mechanism may require actuation from an operator. Any suitable release mechanism is contemplated and possible, including but not limited to buttons, toggles, switches, triggers, handles, levers, pedals, and the like.

[0054] In various aspects, the disengagement mechanism 250 is communicatively coupled to the electrical conductor so that the engagement release mechanism initiates an electrical current. As used herein, the term "communicatively coupled" means that the coupled components are capable of exchanging data signals with each other, such as, for example, electrical signals via a conductive medium, electromagnetic signals via air, optical signals via optical waveguides, and the like.

[0055] The resistive coil 252 may be formed using any conductive material, including but not limited to nichrome, copper, stainless steel, titanium, zirconium, nickel titanium (nitinol), ALUMEL® (Concept Alloys, Inc., Whitmore Lake, Michigan) iron-chromium-aluminum alloys such as 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), combinations or alloys thereof, and the like, but any conductive material is contemplated and possible. After the radiating spacer device 30 is expanded, the clinician may engage the release mechanism, triggering the electrical conductor to generate a current that passes through the resistive coil 252, resulting in heating and detachment of the radiating spacer device 30.

[0056] Reference now Figure 1 and 9 , the delivery system 100 generally includes a radiating spacer device 30. The radiating spacer device 30 can include an implantable balloon 300. The implantable balloon 300 can include a flexible body 302 that is configured to expand or inflate, such that in the expanded state, the flexible body 302 defines a cavity 304 that is configured to hold an inflation fluid 122. In various aspects, the implantable balloon 300 can be in fluid communication with the inflation lumen 112 via a neck 306 of the implantable balloon 300.

[0057] In various aspects, the radiation spacing device 30 is coupled to the distal end of the sleeve 210. The implantable balloon 300 can be attached to the fluid delivery device 20 or engaged with the fluid delivery device 20 in various ways. For example, the implantable balloon 300 can be attached to the sleeve 210 by friction, using an adhesive, welding, brazing, 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 expanded state, the device has an internal volume, and in the deflated state, the device has substantially no internal volume. The terms deflated, collapsed, and forms thereof are used interchangeably to refer to the implantable balloon 300 before filling the implantable balloon 300 with the inflation fluid 122. The terms expanded, inflated, and forms thereof are used interchangeably to refer to the action of changing the implantable balloon 300 from a deflated state to an expanded state.

[0058] Implantable balloon 300 can be formed by any suitable means, including but not limited to thermal processing, extrusion blow molding, injection blow molding, solution dip coating on pre-molded lost wax preform and / or film lamination, electrostatic spinning and similar means on pre-molded lost wax preform. The shape and size of implantable balloon 300 can be suitable for matching the specific anatomical structure or treatment needs of the experimenter. In various aspects, implantable balloon 300 can be manufactured into any shape suitable for tissue displacement. The example of suitable shape includes but is not limited to cylindrical, spherical, oblong, pear-shaped, fusiform, disc-shaped and triangular, although other shapes are also contemplated and possible.

[0059] Implantable balloon 300 can be formed by any biocompatible material. In various aspects, biocompatible material can be a biodegradable polymer. As described herein, biodegradable polymers can include well-tolerated and / or non-reactive when contacting with a subject or its immunoreactive cells and are easy to erode and / or enzymatically degrade and / or dissolve polymers in a subject or its circulatory system over a period of time. Biodegradable polymers allow the radiation spacer device 30 to be eliminated after the treatment is completed, thereby eliminating the need for removal process. Illustrative examples of biodegradable polymers include but are not limited to polylactic acid polymers (PLA, PLLA, PDLA, PDLLA), polycaprolactone (PCL), polylactic acid-co-glycolic acid (PLGA), poly (ethylene glycol) methyl ether-block-poly (lactide-co-glycolide) (PLGA-b-mPEG), poly-4-hydroxybutyric acid (P4HB), combinations thereof and the like.

[0060] In various aspects, the material forming the implantable balloon 300 can be adapted based on the desired mechanical properties (e.g., ductility, forgeability, plasticity, etc.) of the radiation spacer device 30 in vivo and the expected treatment length. For example, a biodegradable polymer can be selected that begins to degrade at the end of radiation therapy. The degradation rate, and therefore the polymer selection, can be determined based on the use of the radiation spacer device 30. When determining an appropriate polymer for forming the implantable balloon 300, the molecular weight, crystal structure, and other various properties of the polymer can be considered.

[0061] In various aspects, when the inflation fluid 122 is a biodegradable hydrogel, both the implantable balloon 300 and the inflation fluid 122 can be formulated to begin to degrade at the expected end of the radiation therapy. In various aspects, this is up to 18 months, such as a range from about 0 months to about 18 months, including 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. It should be understood that the time is only a rough guide for the appropriate formulation of the targeted implantable balloon 300 in general.

[0062] In addition, the material forming the implantable balloon 300 should be flexible enough to allow the flexible body 302 to expand. In various aspects, additives can be included in the material forming the implantable balloon 300 to enhance the desired properties. For example, plasticizers such as triethyl citrate, triacetin, 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 can be added to increase flexibility.

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

[0064] In various aspects, the bioadhesive can form a continuous or discontinuous film between the radiation spacer device 30 and the biological surface. For example, the bioadhesive can include hydroxypropyl methylcellulose, ethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrimidine, polyvinyl alcohol, chitosan, polymethacrylate copolymers, siloxanes, polydimethylsiloxanes, acrylate copolymers, octylacrylamide copolymers, octyl hydrochloride, combinations thereof, and the like.

[0065] like Fig.10 , the implantable balloon 300 generally includes a neck 306 that defines an orifice 308 into the cavity 304. In various aspects, the neck 306 can operably couple the distal end of the fluid delivery device 20 to the radiation spacer device 30. As discussed above, various attachment methods known in the art are contemplated and possible. In various aspects, the neck 306 can define an orifice 308 for passing the inflation fluid 122 into the cavity 304 of the implantable balloon 300. The distal end of the elongated member 110 extends through the cannula lumen 212 and into the orifice 308, thereby fluidly coupling the inflation lumen 112 to the cavity 304.

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

[0067] In various aspects, the cavity 304 can be filled with an inflation fluid 122 to expand or inflate the flexible body 302. In various aspects, the flexible body 302 can expand in response to an increased amount of inflation fluid 122 introduced into the cavity 304. The expansion of the flexible body 302 occurs after the radiation spacer device 30 is inserted into the treatment location, such as between the targeted tissue and the non-targeted tissue. When in the deflated state, the radiation spacer device 30 can be inserted by any suitable insertion method (e.g., an introducer sheath). The clinician can use any suitable guide, including but not limited to ultrasound guidance, guide wires, and the like, to facilitate the insertion and placement of the radiation spacer device 30.

[0068] Once positioned, expansion of the flexible body 302 can be performed to create separation between adjacent tissues. In various aspects, the flexible body 302 is expanded by movement of the inflation fluid 122 from the elongated member 110 to the cavity 304 via the orifice 308 in the neck 306 of the implantable balloon 300. The inflation fluid 122 enables the radiation spacer device 30 to conform to the displaced tissue and create better separation between the targeted tissue and the non-targeted tissue in the expanded configuration. In addition to separation, the inflation fluid 122 can also act as a barrier against heat and / or radiation for further protecting the non-targeted tissue.

[0069] After the implantable balloon 300 is expanded, the radiation spacer device 30 is detached from the fluid delivery device 20. In various aspects, after the implantable balloon 300 is expanded, the distal end of the sleeve 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 retaining the radiation spacer device 30 in place in its expanded state.

[0070] In order to maintain the appropriate space between the targeted tissue and the non-targeted tissue, the radiation spacer device 30 needs to maintain the volume for the expected treatment length. In various aspects, the expanded state is maintained by closing the orifice 308, thereby preventing deflation of the implantable balloon 300. In various aspects, the inflation fluid 122 also helps prevent deflation, such as by using a hydrogel as discussed above.

[0071] In some aspects, closing of the orifice 308 may be accomplished by a valve assembly 40, such as Fig.10 and FIG. 11A to FIG. 11C As used herein, "check valve" and "duckbill valve" refer to valves that allow fluid to flow in one direction while inhibiting reverse flow, and are used interchangeably. In various aspects, such as FIG. 11A to FIG. 11C, one or more duckbill valves 400 can be disposed in the neck 306 of the implantable balloon 300. In various aspects, the radiation spacer device 30 can have a plurality of duckbill valves 400 disposed in the neck 306 of the implantable balloon 300. In various aspects, the neck 306 of the implantable balloon 300 can be reinforced with a tubular sheath (not shown) of a biodegradable material to provide protection and support for the valve assembly 40.

[0072] In various aspects, each duckbill valve 400 has a distally directed (e.g., Figure 1 The distal end extending in the -x direction of the coordinate axis of the Figure 1 The proximal end of the duckbill valve 400 extends in the +x direction of the coordinate axis of the . Each duckbill valve 400 can have a base 402 and a mouth 403. In various aspects, the base 402 can have a generally circular cross-sectional shape, although other shapes are contemplated and possible. In various aspects, the mouth 403 can have a generally flat shape compared to the base 402. In various aspects, the mouth 403 extends distally from the base 402.

[0073] Duckbill valve 400 can define a lumen 412. In various aspects, lumen 412 is in fluid communication with cavity 304 and inflation lumen 112. In various aspects, a distal end of elongated member 110 is disposed within lumen 412 to enable inflation fluid 122 to expand implantable balloon 300. In various aspects, base 402 defines a first lumen portion 413, and mouth 403 defines a second lumen portion 414. In various aspects, second lumen portion 414 can have a reduced cross-sectional area from first lumen portion 413.

[0074] Duckbill valve 400 can be configured to prevent fluid from leaking from implantable balloon 300. In various aspects, mouth 403 defines outlet 406 at the distal end of duckbill valve 400. Outlet 406 can be any acceptable shape (e.g., a slit) that allows for an open configuration and a closed configuration of mouth 403. When inflation fluid 122 passes through duckbill valve 400, inflation fluid 122 generates pressure on mouth 403, thereby maintaining mouth 403 in an open configuration. When the flow of inflation fluid 122 stops, base 403 returns to a flat shape, such as a closed configuration. The closed configuration prevents inflation fluid 122 from leaking out of cavity 304. In various aspects, duckbill valve 400 is arranged so that radiation spacer device 30 does not leak when fully compressed. Such testing, including tension and compression testing, can be performed using any suitable method known in the art, including but not limited to Instron testing and similar tests.

[0075] The duckbill valve 400 can be formed using various conventional molding techniques known in the art (e.g., injection molding). In various aspects, the duckbill valve 400 can be formed from a biodegradable polymer. In various aspects, the duckbill valve 400 can be made from the same material as the implantable balloon 300. The duckbill valve 400 can be made from any material having a degradation profile similar to that of the implantable balloon 300. Any suitable material is contemplated and possible.

[0076] In various aspects, multiple duckbill valves 400 may be nested in series to provide a secure interlock between valves, such as Fig.11A and Fig. 11B . Although two duckbill valves 400 are depicted nested in series, it should be noted that the present disclosure contemplates any additional number of valves. In various aspects, the mouth 403' of the first duckbill valve 400' extends into and is retained in the first lumen portion 413" of the second duckbill valve 400". When the inflation fluid 122 is dispensed from the injection assembly 10, the inflation fluid 122 will force both the mouths 403' and 403" into an open configuration.

[0077] In various aspects, the mouth 403' of the first duckbill valve 400' is angularly rotated relative to the mouth 403" of the second duckbill valve 400". This arrangement further restricts the movement of the inflation fluid 122 out of the cavity 304. In various aspects, the mouth 403' of the first duckbill valve 400' is angularly rotated relative to the mouth 403" of the second duckbill valve 400". The rotation angle allows the inflation fluid 122 to force both the mouths 403' and 403" into the open configuration. Once the flow of the inflation fluid 122 stops, the mouths 403' and 403" return to the closed configuration.

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

[0079] In various aspects, the valve assembly 40 remains in the radiation spacer device 30 after being detached from the fluid delivery device 20. In the absence of a stiffer tubular support, a slight deformation or force against the implantable balloon 300 can open the duckbill valve 400 and allow the inflation fluid 122 to leak out. However, in various aspects, the angular rotation arrangement can allow the 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 a closed configuration, thereby allowing a reverse flow of the inflation fluid 122, the pressure generated by the reverse flow will also reinforce the closed configuration of the first mouth 403'. In addition, moving the radial force vector around the circumference of the duckbill valve 400 allows for a proportional constant sealing action, with multiple duckbill valves 400 exchanging sealing advantages.

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

[0081] In a first embodiment, the present disclosure is directed to a 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 defining an orifice into the cavity; and a plurality of duckbill valves disposed within the orifice, wherein the plurality of duckbill valves are nested in series within each other and arranged relative to each other to limit movement of the fluid out of the cavity.

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

[0083] In a third embodiment, the present disclosure is directed to a radiating spacer device according to any of the preceding embodiments, wherein the implantable balloon is expandable in response to an increasing amount of fluid introduced into the cavity.

[0084] In a fourth embodiment, the present disclosure relates to a radiation spacer device as described in any of the aforementioned embodiments, wherein each duckbill valve of a plurality of duckbill valves comprises: a base defining a first lumen portion; and a mouth extending distally from the base and defining a second lumen portion, the second lumen portion having a cross-sectional area that decreases from the first lumen portion to an outlet formed at a distal end of the duckbill valve; wherein the mouth of the first duckbill valve extends into and is retained in the first lumen portion of the second duckbill valve so that the mouth of the first duckbill valve rotates at an angle relative to the mouth of the second duckbill valve, thereby preventing leakage through the plurality of duckbill valves to limit fluid movement out of the cavity.

[0085] In a fifth embodiment, the present disclosure is directed to the radiating spacer device of any of the preceding embodiments, wherein the mouth of the second duckbill valve is angularly rotated 90 degrees relative to the mouth of the first duckbill valve.

[0086] In a sixth embodiment, the present disclosure is directed to the radiation spacer device of any of the preceding embodiments, wherein the fluid comprises a biodegradable hydrogel. The fluid may further comprise a contrast agent, a biocompatible radiation shielding material, a drug, a chemotherapeutic agent, and / or a combination thereof.

[0087] In a seventh embodiment, the present disclosure is directed to the radiation spacer device of any of the preceding embodiments, wherein the radiation spacer device has a bioadhesive coating or a physical mechanism for reducing mobility of the radiation spacer within an insertion site disposed on an outer surface of the flexible body.

[0088] In an eighth embodiment, the present disclosure relates to a radiation spacer delivery system, comprising: a radiation spacer device, the radiation spacer device comprising an implantable balloon and a plurality of duckbill valves, the 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 into the cavity, the plurality of duckbill valves being disposed within the opening into the cavity, wherein the plurality of duckbill valves are nested in series within each other and arranged relative to each other to restrict movement of the fluid out of the cavity; an injection assembly, comprising: an elongated member and a syringe, the syringe comprising a chamber and a plunger, wherein the chamber is fluidly connected to the elongated member; and a fluid delivery device, comprising: a housing, the housing comprising a sleeve, a support member and an actuator, and a disengagement mechanism.

[0089] In a ninth embodiment, the present disclosure is directed to the radiating spacer delivery system of the preceding embodiment, wherein the radiating spacer device is any one of the first to seventh embodiments.

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

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

[0092] In a twelfth embodiment, the present disclosure is directed to the radiation delivery system of any one of the preceding embodiments, wherein the elongated member is positioned distal to the syringe.

[0093] In a thirteenth embodiment, the present disclosure is directed to the radiation delivery system of any one of the preceding embodiments, wherein the actuator is coupled to the trigger via corresponding gears such that an operator pressing the trigger causes the actuator to depress the plunger.

[0094] In a fourteenth embodiment, the present disclosure relates to a radiation delivery system as described in any of the aforementioned embodiments, wherein each duckbill valve of a plurality of duckbill valves comprises: a base defining a first lumen portion; and a mouth extending distally from the base and defining a second lumen portion, the second lumen portion having a cross-sectional area that decreases from the first lumen portion to an outlet formed at a distal end of the duckbill valve; wherein the mouth of the first duckbill valve extends into and is retained in the first lumen portion of the second duckbill valve such that the mouth of the first duckbill valve rotates at an angle relative to the mouth of the second duckbill valve, thereby preventing leakage through the plurality of duckbill valves to limit fluid movement out of the cavity.

[0095] In a fifteenth embodiment, the present disclosure is directed to the radiation delivery system of any one of the preceding embodiments, wherein the mouth of the second duckbill valve is angularly rotated 90 degrees relative to the mouth of the first duckbill valve.

[0096] In a sixteenth embodiment, the present disclosure is directed to the radiation delivery system of any one of the preceding embodiments, wherein the detachment mechanism comprises a resistive coil. The resistive coil can optionally be disposed within a cannula of the fluid delivery device. Additionally, the resistive coil can be disposed at a distal end of the cannula such that it is located near a point of attachment of the radiation spacer device to the cannula. The resistive coil can detach the radiation spacer device by thermally ablating a neck of the implantable balloon with the resistive coil.

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

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

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

[0100] In a twentieth embodiment, the present disclosure relates to a method for protecting non-targeted tissue from associated radiation, the method comprising: inserting a radiation spacer device between a targeted tissue and a non-targeted tissue, wherein the targeted tissue is intended to receive radiation therapy, the radiation spacer device comprising an implantable balloon and a plurality of duckbill valves, the 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 into the cavity, the plurality of duckbill valves being disposed within the opening into the cavity, wherein the plurality of duckbill valves are nested in series within each other and arranged relative to each other to limit movement of the fluid out of the cavity; expanding the implantable balloon to create a separation between the targeted tissue and the non-targeted tissue, thereby protecting the non-targeted tissue from associated radiation.

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

[0102] In a twenty-second embodiment, the present disclosure relates to a method according to any one of the preceding embodiments, wherein the radiation spacer device is coupled to a fluid delivery apparatus.

[0103] In a twenty-third embodiment, the present disclosure is directed to the method of any one of the preceding embodiments, wherein the fluid delivery device comprises a housing and a disengagement mechanism.

[0104] In a twenty-fourth embodiment, the present disclosure relates to a method according to any one of the preceding embodiments, further comprising detaching the radiation spacer device from the fluid delivery apparatus using a detachment mechanism.

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

[0106] In a twenty-sixth embodiment, the present disclosure is directed to the method of any one of the preceding embodiments, wherein detaching the radiating spacer device comprises thermally ablating a neck of the implantable balloon with a resistive coil.

[0107] In a twenty-seventh embodiment, the present disclosure is directed to the method of any one of the preceding embodiments, wherein expanding the implantable balloon comprises filling the lumen with a fluid.

[0108] In a twenty-eighth embodiment, the present disclosure relates to the method of any one of the preceding 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 preceding embodiments, wherein filling the cavity with the fluid comprises transferring the fluid from an injection assembly to the cavity.

[0110] In a thirtieth embodiment, the present disclosure is directed to the method of any one of the preceding embodiments, wherein the injection assembly comprises an elongated member and a syringe comprising a chamber for holding a fluid and a plunger.

[0111] In a thirty-first embodiment, the present disclosure is directed to a method as described in any of the preceding embodiments, wherein transferring the fluid from the injection assembly to the cavity comprises actuating the plunger to dispense the fluid from the chamber into the elongated member and into the cavity.

[0112] In a thirty-second embodiment, the present disclosure relates to the use of a radiation spacer device and / or a radiation delivery system as described in any one of the preceding embodiments for protecting non-targeted tissue from associated radiation, the use comprising: inserting a radiation spacer device between a targeted tissue and a non-targeted tissue, wherein the targeted tissue is intended to receive radiation therapy, the radiation spacer device comprising an implantable balloon and a plurality of duckbill valves, the 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 into the cavity, the plurality of duckbill valves being disposed within the opening of the cavity, wherein the plurality of duckbill valves are nested in series within each other and are arranged relative to each other to limit the movement of fluid out of the cavity; expanding the implantable balloon to create a separation between the targeted tissue and the non-targeted tissue, thereby protecting the non-targeted tissue from associated radiation.

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

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

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

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

[0117] In a thirty-seventh embodiment, the present disclosure is directed to the use of any one of the preceding embodiments, wherein the disengagement mechanism is a resistive coil.

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

[0119] In a thirty-ninth embodiment, the present disclosure relates to the use of any one of the preceding embodiments, wherein expanding the implantable balloon comprises filling the lumen with a fluid.

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

[0121] In a forty-first embodiment, the present disclosure relates to the use of any one of the preceding embodiments, wherein filling the cavity with the fluid comprises transferring the fluid from an injection assembly to the cavity.

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

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

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

[0125] Although specific embodiments have been shown 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, these aspects need not be used in combination. Therefore, the appended claims are intended to cover all such changes and modifications within the scope of the claimed subject matter.

Claims

1. A 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 defining an orifice into the cavity; as well as A plurality of duckbill valves are disposed within the orifice, wherein the plurality of duckbill valves are nested in series within one another and are arranged relative to one another to restrict movement of the fluid out of the cavity.

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

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

4. The radiation spacer device of claim 1, wherein each duckbill valve of the plurality of duckbill valves comprises: a base defining a first lumen portion; and a mouth extending distally from the base and defining a second lumen portion having a cross-sectional area that decreases from the first lumen portion to an outlet formed at a distal end of the duckbill valve; wherein the mouth of the first duckbill valve extends into and is retained in the first lumen portion of the second duckbill valve such that the mouth of the first duckbill valve is angularly rotated relative to the mouth of the second duckbill valve, thereby preventing leakage through the multiple duckbill valves to limit movement of the fluid out of the cavity.

5. The radiating spacer device of claim 4, wherein the mouth of the second duckbill valve is angularly rotated 90 degrees relative to the mouth of the first duckbill valve.

6. The radiation spacer device of claim 1, wherein the fluid comprises a biodegradable hydrogel.

7. The radiation spacer device of claim 1, wherein the radiation spacer device has a bioadhesive coating or a physical mechanism for reducing mobility of the radiation spacer within an insertion site disposed on an outer surface of the flexible body.

8. A radiation spacer delivery system, comprising: A 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 defining an opening into the cavity, and a plurality of duckbill valves disposed within the opening into the chamber, wherein the plurality of duckbill valves are nested in series within one another and are arranged relative to one another to restrict movement of the fluid out of the chamber; Injection assembly, including: Slender members, and a syringe comprising a chamber and a plunger, wherein the chamber is fluidly coupled to the elongated member; and A fluid delivery device comprising: A housing including a sleeve, a support member and an actuator, and a disengagement mechanism.

9. The radiation spacer delivery system of claim 8, wherein each duckbill valve of the plurality of duckbill valves comprises: a base defining a first lumen portion; and a mouth extending distally from the base and defining a second lumen portion having a cross-sectional area that decreases from the first lumen portion to an outlet formed at a distal end of the duckbill valve; wherein the mouth of the first duckbill valve extends into and is retained in the first lumen portion of the second duckbill valve such that the mouth of the first duckbill valve is angularly rotated relative to the mouth of the second duckbill valve, thereby preventing leakage through the multiple duckbill valves to limit movement of the fluid out of the cavity.

10. The radiating spacer delivery system of claim 9, wherein the mouth of the second duckbill valve is angularly rotated 90 degrees relative to the mouth of the first duckbill valve.

11. The radiating spacer delivery system of claim 8, wherein the disengagement mechanism comprises a resistive coil.

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

13. The radiating spacer delivery system of claim 8, wherein the implantable balloon is a biodegradable polymer.

14. A method for protecting non-targeted tissue from incidental radiation, the method comprising: inserting a radiation spacer device between a targeted tissue and a non-targeted tissue, wherein the targeted tissue is intended to receive radiation therapy, 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 defining an opening into the cavity, and a plurality of duckbill valves disposed within the opening into the chamber, wherein the plurality of duckbill valves are nested in series within one another and are arranged relative to one another to restrict movement of the fluid out of the chamber; The implantable balloon is expanded to create a separation between the targeted tissue and the non-targeted tissue, thereby protecting the non-targeted tissue from incidental radiation.

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

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

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

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

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

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

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

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

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

24. The method of claim 23, wherein the injection assembly comprises an elongated member and a syringe comprising a chamber for retaining the fluid and a plunger.

25. The method according to claim 24, wherein: Transferring the fluid from the injection assembly to the cavity includes actuating the plunger to dispense the fluid from the chamber into the elongated member and into the cavity.

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