WO2025216725A1

WO2025216725A1 - Delivery system for radio-therapeutic cancer treatment

Info

Publication number: WO2025216725A1
Application number: PCT/US2024/023634
Authority: WO
Inventors: Matthew Cullen; Victor Bell; Derek Doyle; Federico SPADOTTO; Franck BOGNER
Original assignee: ClearStream Technologies Ltd
Current assignee: ClearStream Technologies Ltd
Priority date: 2024-04-08
Filing date: 2024-04-08
Publication date: 2025-10-16
Anticipated expiration: 2026-10-08

Abstract

A delivery system for treating cancer and associated methods thereof. The delivery system includes a needle system comprising a needle with a needle lumen supported by a needle hub, and a plurality of beads containing a radio-therapeutic agent. Additionally, the system includes a syringe system comprising a syringe barrel with a syringe cavity, a plunger, a dilutant vial containing a solvent, and a powder vial containing a solute. The plunger is used to mix the solvent with the solute, forming a carrier solution when urged from a first position to a second position. Further urging of the plunger from the second position to a third position causes the carrier solution to be delivered through the needle, forming a matrix that includes the plurality of beads. The matrix is disposed at a target location, e.g., between a rectal wall and prostate. A second hydrogel is deposited to protect the rectal wall.

Description

DELIVERY SYSTEM FOR RADIO-THERAPEUTIC CANCER TREATMENT

BACKGROUND

[0001] Prostate cancer is one of the most prevalent malignancies among men worldwide, representing a significant health burden. Conventional treatment modalities for prostate cancer include surgery, radiation therapy, hormone therapy, chemotherapy, and immunotherapy. However, these treatments may have limitations, including systemic toxicity, damage to surrounding healthy tissues, and limited efficacy, particularly in advanced stages of the disease.

[0002] Radioembolization, also known as selective internal radiation therapy (SIRT), has emerged as a promising therapeutic approach for the treatment of prostate cancer. This technique involves the administration of microscopic radioactive beads directly into the blood vessels that supply the tumor, leading to localized radiation-induced tumor destruction while minimizing damage to healthy tissues. Among the various types of radioembolization beads, yttrium-90 (Y-90) microspheres have gained considerable attention due to their favorable properties, including high energy emission and predictable tissue penetration depth.

[0003] Despite the clinical potential of radioembolization for prostate cancer treatment, challenges remain in achieving precise and efficient delivery of radioembolization beads to the target location within the prostate gland. The successful implementation of radioembolization relies on the development of sophisticated delivery systems capable of navigating the complex vasculature of the prostate while ensuring accurate deposition of the radioactive microspheres within the tumor vasculature.

[0004] Existing delivery systems for radioembolization beads often face limitations such as inadequate targeting precision, suboptimal bead retention within the tumor vasculature, and potential embolization of non-target tissues. Moreover, the variability in prostate anatomy and tumor vasculature among patients further complicates the task of achieving uniform and effective distribution of radioembolization beads.

[0005] Disclosed herein are delivery systems and associated methods directed to address the foregoing. SUMMARY

[0006] In some aspects, the techniques described herein relate to a system for treating prostate cancer including, a needle system including, a needle defining a needle lumen and supported by a needle hub, and a plurality of beads including a radio-therapeutic agent, and a syringe system including, a syringe barrel defining a syringe cavity, a plunger, a dilutant vial containing a solvent, and a powder vial containing a solute, wherein urging the plunger from a first position to a second position causes the solvent to mix with the solute to form a carrier solution, and wherein urging the plunger from the second position to a third position urges the carrier solution through the needle to form a matrix including the plurality of beads.

[0007] In some aspects, the techniques described herein relate to a system, wherein the plurality of beads including the radio-therapeutic agent includes yttrium-90 (Y-90) microspheres.

[0008] In some aspects, the techniques described herein relate to a system, wherein the carrier solution is a saline solution or hydrogel.

[0009] In some aspects, the techniques described herein relate to a system, wherein the first position is proximal to the second position and the second position is proximal to the third position.

[0010] In some aspects, the techniques described herein relate to a system, wherein the plurality of beads are disposed in the needle lumen and secured in place by a distal release liner and a proximal release liner.

[0011] In some aspects, the techniques described herein relate to a system, wherein the plurality of beads are disposed in a hub cavity within the needle hub, the needle hub transitionable between a locked position and an unlocked position by rotating a distal hub portion of the needle hub relative to a proximal hub portion of the needle hub.

[0012] In some aspects, the techniques described herein relate to a system, wherein the proximal hub portion includes a first channel system providing fluid communication between a hub port and the hub cavity, the hub cavity disposed in the distal hub portion, the proximal hub portion further including a second channel system providing fluid communication between the hub cavity and the needle lumen, when the needle hub is in the unlocked position. [0013] In some aspects, the techniques described herein relate to a system, wherein a distal end of the plunger includes a cone shape extending longitudinally.

[0014] In some aspects, the techniques described herein relate to a system, wherein the dilutant vial further includes a vial spike disposed on a distal end and defining a lumen, and wherein the plunger in the second position urges the vial spike distally to penetrate a proximal end of the powder vial and provide fluid communication therewith.

[0015] In some aspects, the techniques described herein relate to a system, wherein a distal tip of the plunger in the second position penetrates or compresses a proximal end of the dilutant vial to urge the solvent through the vial spike lumen into the powder vial.

[0016] In some aspects, the techniques described herein relate to a system, wherein the plunger in the third position urges the powder vial distally onto a syringe cavity spike, disposed at a distal end of the syringe cavity and defining a syringe cavity spike lumen, the syringe cavity spike configured to penetrate a distal end of the powder vial and provide fluid communication between the powder vial and the needle system.

[0017] In some aspects, the techniques described herein relate to a system, wherein the plunger in the third position urges the dilutant vial inside of the powder vial to urge the carrier solution into the needle system.

[0018] In some aspects, the techniques described herein relate to a method of placing a matrix including a plurality of beads having a radio-therapeutic agent including, placing a first dilutant vial and a first powder vial within a syringe body, advancing a needle to a target location, advancing a plunger from a first position to a second position to puncture a proximal end of the first powder vial and urge a solvent from the first dilutant vial into the first powder vial to form a carrier solution, advancing the plunger from the second position to a third position to puncture a distal end of the first powder vial and urge the carrier solution through a needle system to mix with the plurality of beads and form the matrix, and disposing the matrix at a target location.

[0019] In some aspects, the techniques described herein relate to a method, wherein the plurality of beads includes yttrium-90 (Y-90) microspheres. [0020] In some aspects, the techniques described herein relate to a method, wherein the target location is an interstitial location between a rectal wall and a prostate.

[0021] In some aspects, the techniques described herein relate to a method, wherein the carrier solution is a saline solution or a hydrogel.

[0022] In some aspects, the techniques described herein relate to a method, wherein the third position is distal to the second position, and the second position is distal to the first position.

[0023] In some aspects, the techniques described herein relate to a method, further including, retracting the plunger from the third position back to the first position, removing the first dilutant vial and the first powder vial from the syringe body, placing a second dilutant vial and a second powder vial into the syringe body, and actuating the plunger from the first position to the second position and to the third position to deposit a protective hydrogel at the target location.

[0024] In some aspects, the techniques described herein relate to a method, wherein protective hydrogel is different from carrier solution and includes a hydrogel having one or both of an increased cross-linked structure and an increased density.

[0025] In some aspects, the techniques described herein relate to a method, wherein the protective hydrogel disposed between the matrix and a rectal wall.

[0026] In some aspects, the techniques described herein relate to a method, wherein the protective hydrogel provides one or both of an increased spacing between the matrix and the rectal wall and provides an increased absorption of radioactivity from the plurality of beads.

BRIEF DESCRIPTION OF DRAWINGS

[0027] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: [0028] FIG. 1 shows a perspective view of a radioembolization delivery system generally including a syringe system and a needle system, in accordance with embodiments disclosed herein.

[0029] FIG. 2 shows a needle system including radioembolization beads disposed in the needle lumen, in accordance with embodiments disclosed herein.

[0030] FIG. 3 A shows a needle system including radioembolization beads disposed in the needle hub, in accordance with embodiments disclosed herein.

[0031] FIG. 3B shows a lateral cross-section view of the needle system of FIG. 3 A in a locked position, in accordance with embodiments disclosed herein.

[0032] FIG. 3C shows a lateral cross-section view of the needle system of FIG. 3 A in an unlocked position, in accordance with embodiments disclosed herein.

[0033] FIG. 3D shows a lateral cross-section view of a distal portion of the needle system of FIG. 3 A, in accordance with embodiments disclosed herein.

[0034] FIG. 4A shows a perspective view of a syringe system, in accordance with embodiments disclosed herein.

[0035] FIG. 4B shows a longitudinal cross-section view of a syringe system, in accordance with embodiments disclosed herein.

[0036] FIG. 5 shows a longitudinal cross-section view of a syringe system including a dilutant vial and a powder vial loaded therein, in accordance with embodiments disclosed herein.

[0037] FIG. 6A shows a longitudinal cross-section view of a syringe system at a first stage in a method of use, in accordance with embodiments disclosed herein.

[0038] FIG. 6B shows a perspective view of a syringe system at a first stage in a method of use, in accordance with embodiments disclosed herein.

[0039] FIG. 7A shows a longitudinal cross-section view of a syringe system at a second stage in a method of use, in accordance with embodiments disclosed herein. [0040] FIG. 7B shows a perspective view of a syringe system at a second stage in a method of use, in accordance with embodiments disclosed herein.

[0041] FIG. 8A shows a longitudinal cross-section view of a syringe system at a third stage in a method of use, in accordance with embodiments disclosed herein.

[0042] FIG. 8B shows a perspective view of a syringe system at a third stage in a method of use, in accordance with embodiments disclosed herein.

[0043] FIG. 9A shows a longitudinal cross-section view of a syringe system at a fourth stage in a method of use, in accordance with embodiments disclosed herein.

[0044] FIG. 9B shows a perspective view of a syringe system at a fourth stage in a method of use, in accordance with embodiments disclosed herein.

[0045] FIGS. 10A-10C show an exemplary environment of use for the delivery system, in accordance with embodiments disclosed herein.

DESCRIPTION

[0046] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0047] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”

[0048] In the following description, the terms “or” and “and/or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and/or C” mean “any of the following, A, B, C, A and B, A and C, B and C, A, B and C.” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.

[0049] With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a needle or system disclosed herein includes a portion of the needle or system intended to be near or relatively nearer to a clinician when the needle or system is used on a patient. Likewise, a “proximal length” of, for example, the needle or system includes a length of the needle or system intended to be near or relatively nearer to the clinician when the needle or system is used on the patient. A “proximal end” of, for example, the needle or system includes an end of the needle or system intended to be near or relatively nearer to the clinician when the needle or system is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the needle or system can include the proximal end of the needle or system; however, the proximal portion, the proximal end portion, or the proximal length of the needle or system need not include the proximal end of the needle or system. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the needle or system is not necessarily a terminal portion or terminal length of the needle or system.

[0050] With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a needle or system disclosed herein includes a portion of the needle or system intended to be near or relatively nearer to a patient when the needle or system is used on a patient. Likewise, a “distal length” of, for example, the needle or system includes a length of the needle or system intended to be near or relatively nearer to the patient when the needle or system is used on the patient. A “distal end” of, for example, the needle or system includes an end of the needle or system intended to be near or relatively nearer to the patient when the needle or system is used on the patient. The distal portion, the distal end portion, or the distal length of the needle or system can include the distal end of the needle or system; however, the distal portion, the distal end portion, or the distal length of the needle or system need not include the distal end of the needle or system. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the needle or system is not necessarily a terminal portion or terminal length of the needle or system.

[0051] To assist in the description of embodiments described herein, as shown in FIG. 1, a longitudinal axis extends substantially parallel to an axial length of the needle. A lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes.

[0052] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0053] FIG. 1 shows a radioembolization delivery system (“delivery system”) 100 generally including a needle system 110 and a syringe system 150. A proximal end of the needle system 110 couples with a distal end of the syringe system 150, for example, using a luer lock, spin nut, interference-fit engagement, press-fit engagement, snap-fit engagement, or similar suitable means. Once coupled with the syringe system 150, the needle system 110 is in fluid communication with the syringe system, as described in more detail herein. A user can manipulate the delivery system 100 to penetrate a patient and access a target location within the patient’s body, for example, an interstitial space between the prostate and the rectal wall. Advantageously, the syringe system 150 can be interchanged with different needle systems depending on the requirements of the patient or the procedure. Embodiments of different needle systems are described in more detail herein.

[0054] In an embodiment, the needle system 110 generally includes a needle 112 extending along a longitudinal axis and defining a needle lumen 114. The needle 112 terminates at a sharpened distal tip configured for penetrating a skin surface and subcutaneous tissue layers to access a target location within the body of a patient. A proximal end of the needle 112 is supported by a needle hub 116. The needle hub 116 facilitates coupling the needle system 110 with the syringe system 150 and placing the needle lumen 114 in fluid communication with the syringe system 150.

[0055] In an embodiment, the syringe system 150 generally includes a body 152 having a loading opening 158, through which one or more vials, e.g., a diluent vial 172 and a powder vial 176 can be loaded. The syringe system 150 further includes a plunger having a plunger arm 162 extending through an elongate slot 156 disposed in a side wall of the syringe body 152, as described in more detail herein.

[0056] In an embodiment, as shown in FIG. 2, the needle system 110 includes a plurality of radioembolization beads 120 preloaded within the needle system 110, to provide a “preloaded” needle system 110. For example, as shown in FIG. 2, the plurality of radioembolization beads 120 are preloaded within the needle lumen 114 to provide a preloaded “lumen” needle system 110. The needle system 110 further includes one or more release liners disposed over one or both of the distal end and the proximal end of the needle lumen 114 to retain the radioembolization beads 120 within the needle lumen 114 prior to use, e.g., during transport and storage. Exemplary radioembolization beads include yttrium-90 (Y-90) microspheres, however other radioembolization beads including different radioactive elements are also contemplated.

[0057] In an embodiment, the needle system 110 includes a distal release liner 122A disposed over the distal tip of the needle 112 and adhered thereto to retain the distal release liner 122A in place. Similarly, the needle system 110 includes a proximal release liner 122B disposed over the proximal end of the needle 112, and optionally the needle hub 116 as well, and adhered thereto to retain the proximal release liner 122B in place. Advantageously, the release liners 122A, 122B also maintain a sterile environment within the needle lumen 114 and protect the sharpened distal tip and proximal coupling, respectively, from damage during transport and storage. In an embodiment, each of the release liners includes a pull tab, for example a distal pull tab 124A and a proximal pull tab 124B configured to facilitate grasping the release liner and peeling the release liner from the needle system 110.

[0058] In an exemplary method of use, a needle system 110 is provided including a plurality of radioembolization beads 120 disposed within the needle lumen 114 and retained therein by one or more release liners, as described herein. A proximal release liner 122B is peeled away from the needle system 110, and a proximal end of the needle system 110 is coupled with a distal end of the syringe system 150. The distal release liner 122A is peeled away from the needle system 110, and a distal tip of the needle 112 is urged distally to penetrate a skin surface and advanced to a target location within the patient. Exemplary target locations include, for example, between a prostate and rectal wall. However, it will be appreciated to other target locations within the body of a patient are also contemplated such as interstitial spaces, intravascular, combinations thereof, or the like. The syringe system 150 is then actuated to urge the radioembolization beads 120 out of the needle lumen 114 and deposit the radioembolization beads 120 at the target location, as described in more detail herein.

[0059] FIGS. 3A-3D show an embodiment, of a needle system 210 for use with a syringe system 150. In an embodiment, the needle system 210 includes a plurality of radioembolization beads 120 preloaded within a hub 216 of the needle system 210 to provide a preloaded “hub” needle system 210. As shown in FIG. 3 A, the hub 216 includes a proximal hub portion 220 and a distal hub portion 222 rotatably coupled thereto such that the proximal hub portion 220 and the distal hub portion 222 can rotate about a central longitudinal axis 70 relative to each other but are also retained in a fixed position relative to each other along the longitudinal axis.

[0060] A proximal end of the proximal hub portion 220 is configured to engage the syringe system 150, as described herein, and provide fluid communication between the syringe system 150 and the needle system 210. For example, a hub port 218 is configured to engage a distal port 148 of the syringe system 150 and provide fluid communication therewith. A proximal end of the needle 212 is supported by the proximal hub portion 220 and extends distally through a lumen 208 defined by the distal hub portion 222 to extend distally of the needle hub 216. In an embodiment, the distal hub portion 222 defines a hub cavity 224 in which a plurality of radioembolization beads 120 are stored. As shown in FIG. 3D, the hub cavity 224 extends radially about a distal hub portion lumen 208, through which the needle 212 extends.

[0061] As shown in FIG. 3 A, in an embodiment, the proximal hub portion 220 defines both a first channel system 230 and a second channel system 240. The first channel system 230 extends from the hub port 218 to an inlet 226 of the hub cavity 224 and provides fluid communication therewith. The second channel system 240 extends from an outlet 228 of the hub cavity 224 to a proximal end of the needle lumen 214, and provide fluid communication therewith.

[0062] The first channel system 230 includes one or more channels disposed radially about the central longitudinal axis 70 of the proximal hub portion 220. As shown in FIGS. 3B- 3C, the first channel system 230 includes four channels disposed radially about the central longitudinal axis 70. However, it will be appreciated the first channel system 230 can include greater or fewer numbers of channels, or different configurations of channels, without departing from the spirit of the invention.

[0063] The second channel system 240 includes one or more channels disposed radially about the central longitudinal axis 70 of the proximal hub portion 220. As shown in FIGS. 3B- 3C, the second channel system 240 includes four channels disposed radially about the central longitudinal axis. However, it will be appreciated the second channel system 240 can include greater or fewer numbers of channels without departing from the scope of the invention.

[0064] In an embodiment, the proximal hub portion 220 and the distal hub portion 222 are rotatably coupled to each such that the distal hub portion 222 can be rotated about the central longitudinal axis 70 relative to the proximal hub portion 220 between a “locked” position (FIG. 3B) and an “unlocked” position (FIG. 3C). As shown in FIG. 3B, in the locked position, the first channel system 230 and the hub cavity inlet 226 are misaligned preventing any fluid communication therebetween. Similarly, the second channel system 240 and the hub cavity outlet 228 are misaligned, also preventing any fluid communication therebetween. Advantageously, in the locked position, the inlet 226 and the outlet 228 of the hub cavity 224 are blocked and secure the radioembolization beads 120 within the hub cavity 224. As shown in FIG. 3C, in the unlocked position, the first channel system 230 and the hub cavity inlet 226 are aligned allowing fluid communication therebetween. Similarly, the second channel system 240 and the hub cavity outlet 228 are aligned, also allowing fluid communication therebetween.

[0065] In an embodiment, the hub 216 includes a ball-detent torque limiter mechanism or similar mechanism configured to releasably secure the rotation of the proximal hub portion 220 relative to the distal hub portion 222 in either of the locked position or the unlocked position, or at one or more predetermined positions therebetween. Advantageously, this facilitates guiding the rotation of the hub 216 between either of the locked position and the unlocked position, or at a position therebetween to modify the flow rate of the radioembolization beads 120 from the hub 216.

[0066] In an embodiment, the rotation of the proximal hub portion 220 and the distal hub portion 222 is limited to a predetermined arc distance between the locked position and the unlocked position. Exemplary arc distances include 45°, 90°, 180°, 275°, or 360° about the central longitudinal axis 70, or combinations thereof. However, greater or lesser degrees of arc distance are also contemplated. For example, the distal hub portion 222 is configured to rotate 45° in a first direction relative to the proximal hub portion 220, from a locked position to an unlocked position, and rotate 45° in a second direction relative to the proximal hub portion 220, from the unlocked position to a locked position.

[0067] In an exemplary method of use, the needle system 210 is provided as described herein. Once the proximal end of the hub 216 is secured to the syringe system 150, the distal hub portion 222 can be rotated about the longitudinal axis 70 relative to the proximal hub portion 220 from the locked position to the unlocked position to align the first channel system 230 with the hub cavity inlet 226, and to align the second channel system 240 and the hub cavity outlet 228, providing fluid communication therebetween. The syringe system 150 can then be actuated, as described herein, and the radioembolization beads 120 can be urged out of the outlet 228 of the hub cavity 224, through the second channel system 240, and through the needle lumen 214 to a target location. In an embodiment, the distal hub portion 222 can be rotated about the longitudinal axis 70 relative to the proximal hub portion 220 to one or more predetermined positions between the locked position (fully misaligned) and the unlocked position (fully aligned), for example to a position that is 50% aligned to modify a flow rate of radioembolization beads 120 from the hub 216 that is 50% that of the unlocked position. It will be appreciated that the 50% aligned position is exemplary and other predetermined positions that are greater or lesser than 50% are also contemplated.

[0068] FIGS. 4A-4B show further details of the syringe system 150. The syringe system 150 generally includes a body 152 defining a cylindrical shape and having a circular lateral cross-sectional shape. However, it will be appreciated that other cross-sectional shapes are also contemplated. The body 152 defines a cavity 154 that defines a cylindrical shape also having a circular cross-sectional shape. As will be appreciated other cross-sectional shapes are also contemplated, as described herein. The body 152 further includes a port 148 disposed at a distal end and configured to provide fluid communication between the cavity 154 and the needle system 110 coupled with the distal end of the body 152.

[0069] The syringe system 150 further includes a plunger 160 slidably engaged with the cavity 154 of the body 152. The plunger 160 includes an arm 162 extending laterally from a side wall of the plunger 160. The arm 162 extends through an elongate slot 156 disposed in a side wall of the body 152 and extending longitudinally. In use, the arm 162 can be actuated through the slot to slide the plunger 160 along a longitudinal axis. The plunger 160 is slidably engaged with the cavity 154 between a proximal position and a distal position. The syringe system 150 further includes a biasing member 164, for example a compression spring or the like. The biasing member 164 is configured to bias the plunger 160 towards the distal position. In an embodiment, the plunger 160 includes a cone-shaped distal end 166 extending longitudinally.

[0070] In an embodiment, the body 152 includes a loading opening 158 disposed in a side wall and disposed distally on the body 152. The loading opening 158 provides access to the cavity 154 for placing one or more vials 170. The one or more vials 170 define a cylindrical shape and have a circular cross-sectional shape to match the circular cross-sectional shape of the cavity 154. However, it will be appreciated that other cross-sectional shapes such as triangular, rectangular, pentagonal, hexagonal, or similar regular or irregular closed curve polygonal shapes are also contemplated. The one or more vials 170 can be loaded through the loading opening 158 and into the cavity 154.

[0071] In an embodiment, the one or more vials 170 includes a dilutant vial 172 and a powder vial 176. The dilutant vial 172 includes a solvent disposed therein, for example water, saline, or the like. However, it will be appreciated that other hydrophilic, hydrophobic, aqueous, non-aqueous, organic or inorganic solvents are also contemplated. The powder vial 176 includes a solute disposed therein, for example a powder, a hydrocolloid, or the like. However, it will be appreciated that other solutes are also contemplated.

[0072] As shown in FIG. 4A, the dilutant vial 172 is loaded into the cavity 154 and disposed proximally to contact a distal end 166 of the plunger 160. The dilutant vial 172 includes a vial spike 174 disposed at a distal end thereof and defining a spike lumen. As shown in FIG. 4B, the powder vial 176 is then loaded into the cavity 154 and disposed distally between the dilutant vial 172 and the distal end of the body 152 of the syringe system 150.

[0073] As shown in FIG. 5, once loaded, the biasing member 164 can bias the plunger 160 distally to urge the dilutant vial 172 and the powder vial 176 distally and secure the one or more vials 170 in place within the syringe system 150. The needle system, e.g., needle system 110, or needle system 210, can be coupled with syringe system 150 as described herein and the needle tip can be placed at a target location. The user can then urge the plunger arm 162 distally to urge the plunger 160 distally. As the plunger 160 is urged distally, the distal end 166 contacts a proximal end of the dilutant vial 172 and urges the dilutant vial 172 distally such that the vial spike 174, disposed distally, penetrates a proximal end of the powder vial 176 and provides fluid communication between the dilutant vial 172 and the powder vial 176.

[0074] As shown in FIGS. 6A-6B, subsequent to the spike 174 penetrating the powder vial 176, the plunger 160 is continued to be urged distally to where the cone-shaped distal end 166 penetrates and/or compresses the proximal end of the dilutant vial 172 to force the solvent out of the dilutant vial 172 and into powder vial 176, causing the solvent to mix with the solute to create a solution. In an embodiment, the solution is a carrier hydrogel or carrier saline solution. In an embodiment, an outer diameter of the plunger distal end 166 is equal to, or slightly less than, an inner diameter of the dilutant vial 172. As such, as the plunger 160 is urged distally, the plunger fits within the dilutant vial 172.

[0075] In an embodiment, an inner surface of a distal end of the dilutant vial 172 defines a corresponding shape to the outer surface of the plunger distal end 166. For example, where the plunger distal end 166 defines a cone-shape, the inner surface of the distal end of the dilutant vial 172 defines a funnel shape having a similar angled surface to that of the cone 166. As such, once the plunger 160 is advanced to a distal end of the dilutant vial 172, the plunger 160 completely fills the dilutant vial 172 forcing all of the solvent out of the dilutant vial 172, through the lumen of the vial spike 174 and into the powder vial 176. Once the solvent has been urged out of the dilutant vial 172 and into the powder vial 176, the solution will form a carrier, for example a hydrogel or saline solution. It will be appreciated, however, that other carriers are contemplated to fall within the scope of the present invention.

[0076] As shown in FIGS. 7A-7B, the plunger 160 is continued to be urged distally to urge the dilutant vial 172 and the powder vial 176 distally until a distal end of the powder vial 176 abuts against a syringe cavity spike 178. The syringe cavity spike 178 defines a lumen that provides fluid communication with the distal port 148. The syringe cavity spike 178 penetrates a distal end of the powder vial 176 and provides fluid communication between the powder vial 176, the syringe port 148, and needle system 110, 210.

[0077] In an embodiment, the outer diameter of the dilutant vial 172 is equal to, or slightly smaller than the inner diameter of the powder vial 176. As such, as the plunger 160 is continued to be urged distally, the plunger distal end 166 and dilutant vial 172 assembly is urged into the powder vial 176 to urge the carrier solution, disposed therein, distally out of the powder vial 176, through the cavity spike 178, through the syringe port 148 and into the needle system 110, 210.

[0078] As shown in FIGS. 8A-8B, the plunger 160 can continue to be urged distally to urge the dilutant vial 172 into the powder vial 176 until the carrier 260 is urged out of the syringe system 150. In an embodiment, as the carrier 260 is urged out of the syringe system 150 the carrier 260 is urged through the needle lumen 114 to mix with radioembolization beads 120 and form a matrix 270. The matrix 270 of carrier 260 and radioembolization beads 120 is then urged out of the needle 112 to a target location.

[0079] In an embodiment, as the carrier 260 is urged out of the syringe system 150 the carrier is urged through the needle hub 216 of the needle system 210 (in at least the unlocked position) to mix with the radioembolization beads 120 disposed within the needle hub cavity 224 and form a matrix 270. The matrix 270 is then urged out of the needle hub cavity 224, and through the needle lumen 214 to a target location.

[0080] As shown in FIGS. 9A-9B, once the matrix 270 is deposited at the target location, the plunger 160 can be retracted and the dilutant vial 172 and the powder vial 176 can be removed through the loading opening 158.

[0081] FIGS. 10 A- 10C show schematic views of an exemplary target location within the body, for example between a prostate 302 and a rectal wall 304. The needle distal tip can be advanced to the target location as shown in FIG. 10 A. The system 100 can be actuated, as described herein to form the carrier 260, mix the matrix 270 and deposit the matrix 270 including the radioembolization beads 120 at the target location, as shown in FIG. 10B.

[0082] In an embodiment, a second dilutant vial (not shown) and a second powder vial (not shown) can be loaded into the system 100 after the first dilutant vial 172 and the first powder vial 176 have been removed. The second dilutant vial can contain the same solvent as the first dilutant vial 172 or a different solvent. The second powder vial can contain the same solute as the first powder vial 176 or a different solute. In an embodiment, the system 100 can be actuated a second time to mix the second solvent with the second solute, as described herein and provide a second carrier, for example a second hydrogel layer 280 and dispose the second hydrogel layer 280 between the first matrix and the rectal wall. [0083] In an embodiment, the second hydrogel layer 280 can be a relatively highly cross-linked structure and/or an increased density hydrogel. The second hydrogel layer 280 can be a protective layer to provide increased spacing between the radioembolization beads 120 and the rectal wall 304 to mitigate radiation exposure to the rectal wall 304. In an embodiment, the second hydrogel layer 280 can provide increased absorption of radiation to mitigate radiation exposure to the rectal wall 304.

[0084] Advantageously the system 100 includes different predefined dilutant vials 172 and powder vials 176 to provide different types of carrier, for example saline, hydrogels or the like. Further, different amounts of solvent and solute within the dilutant vials and powder vials, respectively, can provide different concentrations or consistencies of carrier 260. For example, a first carrier mixed with the radioembolization beads can provide a relatively thinner, less viscous consistency to allow the matrix to spread more easily between rectal wall 304 and the prostate 302. A second, protective layer, carrier 280 can provide a relatively more viscous, or more dense, material to provide a physical spacing or increased radioactive absorption.

[0085] Advantageously, different carriers 260 or protective layers 280 can be provided by the same delivery system 100 reducing medical waste and reducing associated costs. Further, different carriers 260 or protective layers 280 can be provided by the same delivery system 100 without having to remove the needle distal tip from the target location, speeding up the delivery process, mitigating repeated needle sticks, and obviating the problems of relocating the same target location.

[0086] Advantageously, the delivery system 100 can be provided with a range of dilutant vials 172, powder vials 176, and needle systems including different amounts of radioembolization beads 120, or combinations thereof, that can be mix and matched depending age, weight, size, and/or gender of the patient, and/or the particular medical procedure or dosage required. In an embodiment, the different dilutant vials and powder vials can be coded with an alphanumeric symbol or color-coded to provide predetermined carriers 260 or protective layers 280.

[0087] Advantageously, delivering radioembolization beads 120 outside of the vascular system, and retained within a carrier, provides a more targeted treatment method. The delivery location of the radioembolization beads is more precise and is less vulnerable to travel within the body being both outside of the vascular system and secured within a carrier such as a hydrogel. Further, with the addition of the second carrier, or protective hydrogel, damage to surrounding healthy tissues is mitigated. Securing the radioembolization beads at the target location by the carrier, and optionally by the protective hydrogel 280 provides a more directed and prolonged exposure to radioactive treatment, increasing the efficacy of the radioembolization beads compare with intravascular delivery. In addition, retrieving and removing the radioembolization beads, after the treatment is complete, is facilitated.

[0088] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMS What is claimed is:

1. A system for treating prostate cancer, comprising: a needle system comprising: a needle defining a needle lumen and supported by a needle hub; and a plurality of beads including a radio-therapeutic agent; and a syringe system comprising: a syringe barrel defining a syringe cavity; a plunger; a dilutant vial containing a solvent; and a powder vial containing a solute, wherein urging the plunger from a first position to a second position causes the solvent to mix with the solute to form a carrier solution, and wherein urging the plunger from the second position to a third position urges the carrier solution through the needle to form a matrix including the plurality of beads.

2. The system according to claim 1, wherein the plurality of beads including the radio-therapeutic agent includes yttrium-90 (Y-90) microspheres.

3. The system according to claim 1 , wherein the carrier solution is a saline solution or hydrogel.

4. The system according to claim 1, wherein the first position is proximal to the second position and the second position is proximal to the third position.

5. The system according to claim 1, wherein the plurality of beads are disposed in the needle lumen and secured in place by a distal release liner and a proximal release liner.

6. The system according to claim 1, wherein the plurality of beads are disposed in a hub cavity within the needle hub, the needle hub transitionable between a locked position and an unlocked position by rotating a distal hub portion of the needle hub relative to a proximal hub portion of the needle hub.

7. The system according to claim 6, wherein the proximal hub portion includes a first channel system providing fluid communication between a hub port and the hub cavity, the hub cavity disposed in the distal hub portion, the proximal hub portion further including a second channel system providing fluid communication between the hub cavity and the needle lumen, when the needle hub is in the unlocked position.

8. The system according to claim 1, wherein a distal end of the plunger includes a cone shape extending longitudinally.

9. The system according to claim 8, wherein the dilutant vial further includes a vial spike disposed on a distal end and defining a lumen, and wherein the plunger in the second position urges the vial spike distally to penetrate a proximal end of the powder vial and provide fluid communication therewith.

10. The system according to claim 9, wherein a distal tip of the plunger in the second position penetrates or compresses a proximal end of the dilutant vial to urge the solvent through the vial spike lumen into the powder vial.

11. The system according to claim 1 , wherein the plunger in the third position urges the powder vial distally onto a syringe cavity spike, disposed at a distal end of the syringe cavity and defining a syringe cavity spike lumen, the syringe cavity spike configured to penetrate a distal end of the powder vial and provide fluid communication between the powder vial and the needle system.

12. The system according to claim 1, wherein the plunger in the third position urges the dilutant vial inside of the powder vial to urge the carrier solution into the needle system.

13. A method of placing a matrix including a plurality of beads having a radio- therapeutic agent, comprising: placing a first dilutant vial and a first powder vial within a syringe body; advancing a needle to a target location; advancing a plunger from a first position to a second position to puncture a proximal end of the first powder vial and urge a solvent from the first dilutant vial into the first powder vial to form a carrier solution; advancing the plunger from the second position to a third position to puncture a distal end of the first powder vial and urge the carrier solution through a needle system to mix with the plurality of beads and form the matrix; and disposing the matrix at a target location.

14. The method according to claim 13, wherein the plurality of beads includes yttrium-90 (Y-90) microspheres.

15. The method according to claim 13, wherein the target location is an interstitial location between a rectal wall and a prostate.

16. The method according to claim 13, wherein the carrier solution is a saline solution or a hydrogel.

17. The method according to claim 13, wherein the third position is distal to the second position, and the second position is distal to the first position.

18. The method according to claim 13, further comprising: retracting the plunger from the third position back to the first position; removing the first dilutant vial and the first powder vial from the syringe body; placing a second dilutant vial and a second powder vial into the syringe body; and actuating the plunger from the first position to the second position and to the third position to deposit a protective hydrogel at the target location.

19. The method according to claim 18, wherein protective hydrogel is different from carrier solution and includes a hydrogel having one or both of an increased cross-linked structure and an increased density.

20. The method according to claim 18, wherein the protective hydrogel disposed between the matrix and a rectal wall.

21. The method according to claim 20, wherein the protective hydrogel provides one or both of an increased spacing between the matrix and the rectal wall and provides an increased absorption of radioactivity from the plurality of beads.