Mixing syringe systems and associated methods

Abstract

In one embodiment, a mixing syringe system includes a dual barrel syringe, a first vacuum vial, a second vacuum vial, and an adaptor. The dual barrel syringe includes a first barrel portion and a second barrel portion. The adaptor is attachable to the first barrel portion and the second barrel portion. The adaptor includes a first receptacle for receiving the first vacuum vial and a second receptacle for receiving the second vacuum vial. The adaptor includes a piercing tool for piercing and fluidically coupling the first vacuum vial to the first barrel portion and the second vacuum vial to the second barrel portion.

Description

P-29545. W 001 -53516-30171M IXING SYRINGE SYSTEMS AND ASSOCIATED METHODS BACKGROUNDField

[0001] The present disclosure generally relates to syringe systems and methods and, more particularly, syringe systems and methods for mixing constituent materials for radiation spacers.Technical Background

[0002] Prostate cancer is the most common non- skin cancer diagnosed in men. Radiation therapy is an excellent treatment option for prostate cancer. However, radiation exposure can cause unintended side effects in adjacent non- targeted tissue. A radiation spacer, such as a radio protective spacer, can be implanted to avoid collateral radiation and minimize injury to nearby tissues by providing a space between the target tissue and non-targeted tissues at risk.

[0003] Conventional radiation spacers may include gelling materials, which are delivered as a liquid and allowed to cure. However, constituent components of the gel may begin to gel on contact with one another, which may make delivery difficult. Moreover, constituent components may need to remain separate until time of use, otherwise they may degrade over time due to limited stability. This may lead to complicated and / or tedious processes.SUMMARY

[0004] Embodiments of the present disclosure are directed to various syringe systems, which may maintain separation of constituent materials until time for use of the mixed constituent materials.

[0005] In one embodiment, a mixing syringe system includes a dual barrel syringe, a first vacuum vial, a second vacuum vial, and an adaptor. The dual barrel syringe includes a first barrel portion and a second barrel portion. The adaptor is attachable to the first barrel portion and the second barrel portion. The adaptor includes a first receptacle for receiving the first vacuum vial and a second receptacle for receiving the second vacuum vial. The adaptor includes a piercing tool for piercing and fluidically coupling the first vacuum vial to the first barrel portion and the second vacuum vial to the second barrel portion.

[0006] In another embodiment, a mixing syringe system includes a dual barrel syringe, a first vacuum vial, a second vacuum vial, an adaptor, and a collar. The dual barrel syringe includes a first barrel portion and a second barrel portion. The adaptor includes a first receptacle for receiving the first vacuum vial and a second receptacle for receiving the second vacuum vial. The adaptor includes a piercing tool for piercing and fluidically coupling the first vacuum vial to theP-29545. W 001 -53516-30172 first barrel portion and the second vacuum vial to the second barrel portion. The collar is configured to removably couple the dual barrel syringe to the adaptor.

[0007] In yet another embodiment, a method of preparing a mixture of constituent materials for delivery with a mixing syringe system is also disclosed. The method may include coupling an adaptor to a dual barrel syringe, the dual barrel syringe including a first barrel portion housing a first diluent and a second barrel portion housing a second diluent, wherein the adaptor has a first receptacle, a second receptacle, and a piercing tool within both the first receptacle and the second receptacle. The method further includes positioning a first vacuum vial containing a first particulate material under vacuum pressure into the first receptacle, thereby piercing the first vacuum vial and fluidically coupling the first barrel portion to the first vacuum vial. The method further includes positioning a second vacuum vial containing a second particulate material under vacuum pressure into the second receptacle, thereby piercing the second vacuum vial and fluidically coupling the second barrel portion to the second vacuum vial. Fluidically coupling the first vacuum vial to the first barrel portion and the second vacuum vial to the second barrel portion automatically causes the first diluent to flow into the first vacuum vial and the second diluent to flow into the second vacuum vial.

[0008] Additional features and advantages of the aspects described herein will be set forth in the detailed description, which follows, and in part will be readily apparent to those skilled in the art from that description or recognized by practicing the aspects described herein, including the detailed description, which follows, the claims, as well as the appended drawings.

[0009] It is to 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 drawings illustrate the various aspects described herein, and together with the description serve to explain the principles and operations of the claimed subject matter.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The embodiments set forth in the drawings are illustrative and exemplary in nature and 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, wherein like structure is indicated with like reference numerals and in which:P-29545. W 001 -53516-30173

[0011] FIG. 1 schematically depicts an illustrative syringe system including a dual barrel syringe, an applicator, a collar, and an adaptor according to one or more embodiments shown and described herein;

[0012] FIG. 2A schematically depicts a side view of the dual barrel syringe of FIG. 1 in isolation along with a cap, according to one or more embodiments shown and described herein;

[0013] FIG. 2B schematically depicts a perspective view of the cap of FIG. 2 A spaced from the dual barrel syringe, according to one or more embodiments shown and described herein;

[0014] FIG. 2C schematically depicts a perspective view of a distal end of the dual barrel syringe of FIG. 2B, according to one or more embodiments shown and described herein;

[0015] FIG. 3 schematically depicts a perspective view of a proximal end of the adaptor of FIG. 1, according to one or more embodiments shown and described herein;

[0016] FIG. 4 A schematically depicts the collar of FIG. 1 in isolation, according to one or more embodiments shown and described herein;

[0017] FIG. 4B schematically depicts a sectional view of the collar of the FIG. 4A, according to one or more embodiments shown and described herein;

[0018] FIG. 5A schematically depicts a single vacuum vial, according to one or more embodiments shown and described herein;

[0019] FIG. 5B schematically depicts two vacuum vials provided in a vacuum vial assembly, according to one or more embodiments shown and described herein;

[0020] FIG. 6A schematically depicts a spaced apart arrangement of the dual barrel syringe, the collar, and the adaptor of FIG. 1, according to one or more aspects shown and described herein;

[0021] FIG. 6B schematically depicts a longitudinal cross-section of the dual barrel syringe, the collar, and the adaptor of FIG. 6A engaged with one another, according to one or more embodiments shown and described herein;

[0022] FIG. 6C schematically depicts a sectional view of the collar of FIG. 6B rotated to couple the dual barrel syringe to the adaptor and alignment of the vacuum vial assembly of FIG. 5B with the adaptor, according to one or more embodiments shown and described herein;

[0023] FIG. 6D schematically depicts full engagement of the vacuum vial assembly of FIG. 6C into the adaptor and depression of plungers of the dual barrel syringe, according to one or more embodiments shown and described herein;

[0024] FIG. 6E schematically depicts partial withdrawal of the plungers of FIG. 6D, according to one or more embodiments shown and described herein;P-29545. W 001 -53516-30174

[0025] FIG. 7A schematically depicts the dual barrel syringe of FIG. 6E adjacent to the applicator of FIG. 1, according to one or more embodiments shown and described herein;

[0026] FIG. 7B schematically depicts a sectional view of the applicator of FIG. 7A engaged with the dual barrel syringe, according to one or more embodiments shown and described herein;

[0027] FIG. 7C depicts the applicator rotated relative to FIG. 7B to couple to the dual barrel syringe to provide an applicator assembly, according to one or more embodiments shown and described herein; and

[0028] FIG. 7D schematically depicts delivery of a radiation spacer from the applicator assembly of FIG. 7C, according to one or more embodiments shown and described herein.DETAILED DESCRIPTION

[0029] The present disclosure is generally directed to syringe systems for mixing a plurality of constituent materials. Moreover, the present disclosure is directed to syringe systems configured for preparing and / or delivering a radiation spacer to a desired location within a subject. For example, radiation spacers may be formed of one or more hydrogel materials, which may be delivered to a desired location, such as within a balloon or on its own and cured in place to block or substantially block radiation, which may be unintentionally directed toward healthy tissue instead of targeted / diseased tissue. During mixing of the hydrogel for forming a radiation spacer, multiple materials may need to be combined just prior to and / or at delivery of the radiation spacer into a target location within the body. To maintain quality of material, particulate materials may need to be kept dry or un- constituted prior to application. However, during use, particulate materials may need to be hydrated or mixed with a diluent. It may be difficult to determine proper mixing volumes, maintain sterility, and prevent unwanted early mixing using traditional methods. Moreover, conventional mixing procedures may have numerous steps, be difficult to perform, may result in unwanted bubbles / foaming, and / or may provide inconsistent results. Embodiments of the present disclosure may provide constituent materials in prepackaged, pre-measured, ready- to use syringe assemblies, which, as will be described in greater detail herein, improves mixing, maintains sterility, and / or improves delivery. Embodiments further reduce workflow steps as compared to conventional mixing procedures, provide for easy operation, repeatable results, and may minimize bubble formation / foaming.

[0030] In one particular embodiment, a syringe system for mixing of constituent materials includes a dual barrel syringe including a first barrel portion, a second barrel portion. The system further includes an adaptor which is attachable to the first barrel portion and the second barrelP-29545. W 001 -53516-30175 portion. The adaptor may be sized and shaped to receive vacuum vials, as described in greater detail herein. The adaptor may include piercing elements which allow the vacuum vials to be mounted within the adaptor and fluidically coupled to a respective barrel portion. Particulate material may be stored in pre-measured amounts within the vacuum vials, which may maintain sterility and dryness of the particulate. Liquid constituent materials may be stored in pre-measured amounts within the respective first and second barrel portions such that when mounted to a vacuum vial, via the adaptor, vacuum pressure within the vacuum vials causes liquid to evacuate from the first and second barrel portions and into the respective vacuum vials for mixing. Once sufficiently mixed with the pre-measured powder constituent materials, plungers on the dual barrel syringe may be withdrawn to withdraw respective mixtures back into respective barrels. In embodiments, an applicator may then be attached to the dual barrel syringe for delivery of the mixtures within the respective barrels to a target location as described in greater detail herein. Embodiments described herein may provide for quick, efficient mixing and / or delivery of component materials.

[0031] The systems, devices, and methods described herein are described with a quarter turn coupling mechanism that is used to couple components together for the purposes of mixing. It should be understood that the term “quarter turn” as used herein refers to a rotation that completes about one fourth of a lull rotation. That is, a quarter turn rotation rotates about 90° clockwise or counterclockwise. The components described herein are referred to as “quarter turn” components because the components allow about a 90° rotation of components relative to one another. However, it should be understood that the use of quarter turn connectors is only one illustrative example, and other types of connectors (whether tuming / rotating connectors, snap-in connectors, press fit connectors, etc.) are contemplated and included in the scope of the present disclosure. In particular, proposed quarter turn connectors may be further described in International Patent Application No. PCT / US2021 / 023171, entitled “Multi-Component Sealant Delivery Systems Incorporating Quarter Turn Connectors,” filed March 19, 2021, and International Patent Application No. PCT / US2024 / 028909, entitled “Syringe Systems and Associated Methods,” filed May 10, 2024, the entireties of which are hereby incorporated by reference.

[0032] Directional terms as used herein - for example up, down, right, left, front, back, top, bottom - are made only with reference to the figures as drawn and are not intended to imply absolute orientation unless otherwise specified.P-29545. W 001 -53516-30176

[0033] Unless otherwise expressly stated, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any device or assembly claim does not actually recite an order or orientation of individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation of components of an device or assembly is not recited, it is in no way intended that an order or orientation be inferred, in any respect. This holds for any possible nonexpress basis for interpretation, including: matters of logic with respect to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation; and the number or type of embodiments described in the specification.

[0034] As used herein, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0035] Turning now to the figures, FIG. 1 depicts an illustrative syringe system 100 for mixing constituent materials according to various embodiments. The syringe system 100, in accordance with an aspect of the present disclosure, may be used for mixing and / or delivery of a radiation spacer such as noted above.

[0036] The syringe system 100 generally includes a dual barrel syringe 110 and an adaptor 120 for receiving one or more vacuum vials 160 (depicted in FIG. 5 A and 5B). In some embodiments, the syringe system 100 may further include a collar 140 for coupling the adaptor 120 to the dual barrel syringe 110 and / or an applicator 130 for delivery of a radiation spacer or other combined hydrogel material, for example. Systems according to the present disclosure may include a greater or fewer number of components without departing from the scope of the present disclosure. For example, in some embodiments, the syringe system 100 may further include one or more vacuum vials 160 (depicted in FIGS. 5 A and 5B, for example), described in greater detail below. The various components for the syringe system 100 may be keyed via a connection system such that the dual barrel syringe 110 can be coupled to the adaptor 120 for mixing components of a multi-component material, removed from the adaptor 120, and coupled to the applicator 130 for further mixing and delivery of components, as indicated by the dashed lines in FIG. 1 and described herein. When coupled to the adaptor 120, the combination of the adaptor 120 and theP-29545. W 001 -53516-30177 dual barrel syringe 110 may be referred to herein as a mixing apparatus 200, as depicted in FIGS. 6A-6E. When coupled to the applicator 130, the combination of the applicator 130 and the dual barrel syringe 110 may be referred to herein as a delivery apparatus 250, an embodiment of which is depicted in FIG. 7A-7D.

[0037] Still referring to FIG. 1, in embodiments, the dual barrel syringe 110 may include a barrel body 112. The barrel body 112 may define a first barrel portion 112a, a second barrel portion 112b. It is noted that while two barrel portions are depicted, any number of barrel portions are contemplated and possible. In embodiments, the first barrel portion 112a and the second barrel portion 112b may be integral with one another. In other embodiments, the first barrel portion 112a and the second barrel portion 112b may be coupled to one another such as via, welding, adhesives, fasteners, brackets, etc. By being coupled one another or otherwise integral with one another, simultaneous mixing and delivery to and / or from both the first and second barrel portions 112a, 112b may be more easily executed by a user. The barrel body 112 further includes a first port 112a- 1 fluidically coupled to the first barrel portion 112a, and a second port 112b- 1 fluidical ly coupled to the second barrel portion 112b. The dual barrel syringe 110 may further include a plunger 114a, 114b corresponding to each of the first barrel portion 112a and the second barrel portion 112b. That is, the first barrel portion 112a and the second barrel portion 112b may define two hollow voids within which the respective plungers 114a, 114b may slidingly move. The dual barrel syringe 110 may have a proximal end 113a which provides an opening into each of the respective first barrel portion 112a and second barrel portion 112b for receiving the plungers 114a, 114b. At a distal end 113b opposite the proximal end 113a are positioned the first port 112a- 1 and the second port 112b- 1. The first port 112a- 1 and the second port 112b- 1 may be used for delivering material, such as to / from the adaptor 120 or to the applicator 130, as will be described in greater detail herein. As depicted, the first port 112a- 1 and the second port 112b- 1 may be offset, such as radially offset, from a centerline of each respective barrel portion 112a, 112b, such as toward one another as depicted. This may be useful in providing a more compact assembly. However, in some embodiments, the first port 112a- 1 and the second port 112b- 1 may be aligned with the centerline of each respective barrel portion 112a, 112b.

[0038] Referring briefly to FIG. 6B, within each respective barrel portion 112a, 112b may be a first diluent 101a and a second diluent 101b. Diluents may be any liquid component material able to dissolve or suspend a particulate material therein. For example, in some embodiments, the first diluent 101a, the second diluent 101b, or both may be saline, water, deionized water, or the like. The first and second diluents 101a, 101b may be the same or different from one another.P-29545. W 001 -53516-30178Moreover, the first and second diluents 101a, 101b may be provided in the same or differing amounts.

[0039] Referring collectively to FIG. 1 and FIG. 6B, the plungers 114a, 114b may be slidably disposed, respectively, in the first barrel portion 112a and the second barrel portion 112b of the barrel body 112 and may form a fluidic seal with the barrel body 112 via a seal 114a- 1, 114b- 1 at a distal end of each plunger 114a, 114b. For example, the seal 114a- l, 114b- 1 may be a rubber or similar conformable material for forming a fluid-tight seal with the barrel body 112. At a proximal end of each plunger 114a, 114b may be a pusher flange 114a-2, 114b-2 for a user to engage for advancing the plunger 114a, 114b along the barrel body 112. In some embodiments, a plunger connector 115 may encapsulate both of the pusher flanges 114a-2, 114b-2 thereby synchronizing movement to the plungers 114a, 114b with one another. Such may ensure mixing and / or delivery happens concurrently.

[0040] Referring to FIGS. 2A-2C, the barrel body 112 of the dual barrel syringe 110 is depicted in isolation. As depicted in FIG. 2A, in some embodiments the first port 112a- 1 and the second port 112b- 1 may be initially covered by a cap 500. The cap 500 may be kept in place over the first port 112a-l and the second port 112b- 1 until assembly of the dual barrel syringe 110 to other components of the syringe system 100 is desired. The cap 500 may keep liquid constituent materials, such as the first diluent 101a and the second diluent 101b, from leaking from the dual barrel syringe 110. Once a user is ready to initiate mixing or delivery, the cap 500 may be removed such as depicted in FIG. 2B.

[0041] Referring to FIGS. 1 and 2C, to facilitate coupling with various components of the syringe system 100, the dual barrel syringe may further include a connector integrated with the distal end 113b of the dual barrel syringe 110 about the first port 112a- 1 and the second port 112b- 1. In the embodiments described herein, the barrel body 112 of the dual barrel syringe 110 includes a quarter turn connector 300 integrated with the distal end 113b of the dual barrel syringe 110. More specifically, the various components of the quarter turn connector 300 are integrated with the barrel body 112 such that the quarter turn connector 300 and the barrel body 112 are a single monolithic piece. However, it should be understood that this is merely illustrative and the various components of the quarter turn connector 300 may be separate pieces that are permanently or semi-permanently joined with the barrel body 112 of the dual barrel syringe 110. Further, as described herein, the quarter turn connector 300 is merely illustrative, and other connectors may be utilized in lieu of the quarter turn connector 300 without departing from the scope of the present disclosure.P-29545. W 001 -53516-30179

[0042] The quarter turn connector 300 is generally located at the distal end 113b of the barrel body 112 such that various components of the quarter turn connector 300 are positioned adjacent to the first port 112a- 1 and the second port 112b- l . As will be described herein, the various components of the syringe system 100 may couple to one another via a quarter turn coupling structure. For example, the quarter turn connector 300 is generally shaped and sized to releasably interlock with a corresponding quarter turn connector 450 of the collar 140 (though it is contemplated the quarter turn connector 300 may connect directly to the adaptor 120) and / or with a corresponding quarter turn connector 550 of the applicator 130. As will be described in greater detail herein, when the applicator 130 or the adaptor 120 is coupled to the dual barrel syringe 110 via the quarter turn connectors 300, 400, 450, or 550 thereof the various ports thereof are aligned and sealed with the first port 112a- 1 and the second port 112b- 1 of the dual barrel syringe 110.

[0043] Still referring to FIG. 1 and 2C, the quarter turn connector 300 of the dual barrel syringe 110 may include a first coupling member 306a and a second coupling member 306b. The first coupling member 306a and the second coupling member 306b may be positioned opposite one another such that the first port 112a- 1 and the second port 112b- 1 are positioned between the first coupling member 306a and the second coupling member 306b. For example, the first port 112a- 1 and the second port 112b- 1 may extend adjacent to one another in a distal direction (e.g., in the -x direction of the coordinate axes) in a protruding fashion. In such embodiments, the first port 112a- 1 may be defined by a first port column 314a and the second port 112b- 1 may be defined by a second port column 314b. The first port column 314a and the second port column 314b may include a reduced diameter neck region 316, within which an O-ring or similar sealing device 317 (depicted in FIG. 2B) may be positioned. The sealing device 317 may assist in providing a fluid- tight seal when engaged with various components of the syringe system 100, described in greater detail below.

[0044] Each of the first coupling member 306a and a second coupling member 306b may be positioned in spaced relationship to the respective first port column 314a and the second port column 314b, thereby defining a path therebetween. Each of the first port column 314a and the second port column 314b may be generally shaped and sized to be received within and seal against a corresponding recess formed in the applicator 130 and / or the collar 140, as described in greater detail herein. The distance that the first port column 314a and the second port column 314b extend away from the distal end 113b of the barrel body 112 may generally be a distance that correspondsP-29545. W 001 -53516-301710 to a depth of the recess formed in the applicator 130 and the collar 140 such that the first port column 314a and the second port column 314b may be completely inserted therein.

[0045] The first coupling member 306a and the second coupling member 306b each extend from the distal end 113b of the barrel body 112 of the dual barrel syringe 110 and are generally shaped and sized to retain the applicator 130 or the collar 140 when coupled to the dual barrel syringe 110. Each of the first coupling member 306a and the second coupling member 306b may be a bayonet style coupling member, an L-beam coupling member, or the like. For example, as particularly depicted in FIG. 1, the first coupling member 306a extends distally at a particular distance from the distal end 113b of the barrel body 112, turns about 90 degrees, and extends inward toward a the center axis Cl of the barrel body 112, resulting in a first extension piece 306a- 1 that extends in a direction generally parallel with the center axis Cl of the barrel body 112 (e.g., along the x-axis of the coordinate axes of FIG. 1) and a second extension piece 306a-2 that extends in a direction that is generally perpendicular to the center axis Cl of the barrel body 112 (e.g., along the z-axis of the coordinate axes of FIG. 1), thereby defining a pocket 307a between the distal end 113b of the barrel body 112 and the second extension piece 306a-2. Similarly, the second coupling member 306b extends distally at a particular distance from the distal end 113b of the barrel body 112, turns about 90 degrees, and extends inward toward the center axis Cl of the barrel body 112, resulting in a first extension piece 306b- 1 that extends in a direction generally parallel with the center axis Cl of the barrel body 112 (e.g., along the x-axis of the coordinate axes of FIG. 1) and a second extension piece 306b-2 that extends in a direction that is generally perpendicular to the center axis Cl of the barrel body 112 (e.g., along the z-axis of the coordinate axes of FIG. 1), thereby defining a pocket 307b between the distal end 113b of the barrel body 112 and the second extension piece 306b-2.

[0046] As depicted in FIG. 1-2C, the first coupling member 306a and the second coupling member 306b are located opposite one another. However, this is merely illustrative, and other locations and spacing are contemplated and included within the scope of the present disclosure. Further, while the present embodiment includes a pair of coupling members (e.g., the first coupling member 306a and the second coupling member 306b), this is also merely illustrative. That is, other amounts of coupling members are also contemplated and included within the scope of the present disclosure.

[0047] As noted above, in some embodiments, such as depicted in FIG. 2A, the cap 500 may engage the distal end 113b of the dual barrel syringe 110. For example, the cap 500 may extend over and seal against the first port column 314a and the second port column 314b, therebyP-29545. W 001 -53516-301711 preventing material leakage from respective ports 112a- 1, 112b- 1. In some embodiments, the cap 500 may cover the first and second coupling members 306a, 306b. As depicted in FIG. 2B, the cap 500 may include recesses 502 formed therein that is sized to receive port columns 314a, 314a and engage the corresponding sealing devices 317 to provide a fluid tight seal. Such may ensure integrity of the fluid held within the first barrel portion 112a and the second barrel portion 112b.

[0048] Turning now to FIGS. 1 and 3, the adaptor 120 is attachable to the first barrel portion 112a and the second barrel portion 112b. For example, the adaptor 120 may be couplable to the first barrel portion 112a and the second barrel portion 112b through the collar 140. However, that is only one potential implementation. In some embodiments, the adaptor 120 may directly couple to the first barrel portion 112a and the second barrel portion 112b.

[0049] Referring again to FIG. 1, the adaptor 120 may generally include an adaptor body 121 having a proximal end 122a and a distal end 122b spaced a distance apart from the proximal end 122a. The adaptor body 121 may define a pair of receptacles including a first receptacle 121a for receiving a first vacuum vial and a second receptacle 121b for receiving a second vacuum vial. Each of the first receptacle 121a and the second receptacle 121b may include structure for receiving a first vacuum vial and a second vacuum vial. In embodiments, the first receptacle 121a and the second receptacle 121b may each be defined by a substantially cylindrical wall (e.g., a first substantially cylindrical wall 124a and a second substantially cylindrical wall 124b, respectively). In some embodiments, the first receptacle 121a and the second receptacle 121b may be separated from one another. In such embodiments, each substantially cylindrical wall 124a, 124b may completely encircle a volume of the respective first receptacle 121a and the second receptacle 121b. However, in some embodiments, such as depicted in FIG. 6B, the first substantially cylindrical wall 124a and the second substantially cylindrical wall 124b may not frilly encircle a volume of the first and second receptacles, respectively. Instead, the first substantially cylindrical wall 124a and the second substantially cylindrical wall 124b may join to one another while leaving an opening between a volume of the first receptacle 121a and a volume of the second receptacle 121b.

[0050] Referring specifically to FIG. 6B, the adaptor 120 may further include a piercing tool 150. The piercing tool 150 may be configured to pierce and fluidically couple a first vacuum vial to the first barrel portion 112a and a second vacuum vial to the second barrel portion 112b. For example, the piercing tool 150 may include a first piercing needle 150a positioned within the first receptacle 121a and a second piercing needle 150b positioned within the second receptacle 121b. Each piercing needle 150a, 150b may include an elongate body 150a-l, 150b-l, a piercingP-29545. W 001 -53516-301712 tip 150a-2, 150b-2, and a needle lumen 150a-3, 150b-3 extending therethrough. The piercing needles 150a, 150b may each by coupled to a needle hub 152a, 152b, such as via overmolding, adhesive or the like. The needle hub 152a, 152b may provide a coupling structure for coupling to a needle retention structure 154a, 154b. For example, the needle retention structures 154a. 154b, may have an increased diameter relative to the piercing needle 150a, 150b so as to radially fill a volume of the first or second receptacle 121a, 121b. In embodiments, there is a first retention structure 154a and a second retention structure 154b. The first retention structure 154a and the second retention structure 154b may be integral or separate from one another. Each of the first retention structure 154a and the second retention structure 154b may be coupled to the adaptor body 121 via any suitable technique, such as press-fit or adhesively coupled. In embodiments, the first retention structure 154a and the second retention structure 154b define a mounting orifice 154a- l, 154b- 1 to receive the respective needle hub 152a, 152b. In embodiments, the needle hubs 152a, 152b may threadingly engage with the respective mounting orifice 154a- l, 154b- 1, though other coupling techniques are contemplated and possible. In some embodiments, the piercing needles 150a, 150b may instead be integral with the respective retention structures 154a, 154b. The piercing tool 150 may be formed of any suitable materials or combination of suitable materials including, metals, polymers, or the like.

[0051] Referring again to FIG. 1 and 3, the adaptor body 121 may further define a first adaptor port 121a- 1 fluidically coupled to the first receptacle 121a and a second adaptor port 121b- 1 fluidically coupled to the second receptacle 121b. Referring again to FIG. 6B, the first adaptor port 121a- 1 may be fluidically coupled to the needle lumen 150a-3 and the second adaptor port 121b- 1 may be fluidically coupled to the second needle lumen 150b-3. The first adaptor port 121a- 1 of the first receptacle 121a and the second adaptor port 121b- 1 of the second receptacle 121b may be arranged within and / or on a proximal end 122a of the adaptor body 121 of the adaptor 120. The first adaptor port 121a- 1 and the second adaptor port 121b-l are generally outputs / inputs that are aligned with other ports of other components as described herein such that materials may be passed therethrough to other system components. In some aspects, the first adaptor port 121a- 1 may be concentrically aligned with the first receptacle 121a and the second adaptor port 121b- 1 may be concentrically aligned with the second receptacle 121b. However, in other aspects, such as the aspect depicted in FIG. 1, the first adaptor port 121a- 1 may be located radially inward of a central area of the first receptacle 121a and the second adaptor port 121b- 1 may be located radially inward of a central area of the second receptacle 121b such that the first adaptor port 121a- 1 andP-29545. W 001 -53516-301713 the second adaptor port 121b- 1 are closer to a center axis C2 of the adaptor body 121 of the adaptor 120 to facilitate alignment with the other components of the syringe system 100 described herein

[0052] Still referring to FIG. 1 and 3, the adaptor 120 may include a quarter turn connector 400 that is substantially identical to that of the dual barrel syringe 110. In particular, the adaptor 120 has a first coupling member 406a and a second coupling member 406b. The first coupling member 406a and the second coupling member 406b each extend from the proximal end 122a of the adaptor body 121 of the adaptor 120 and are generally shaped and sized to retain the collar 140 when coupled to the adaptor 120. Each of the first coupling member 406a and the second coupling member 406b may be a bayonet style coupling member, an L-beam coupling member, or the like. For example, as particularly depicted in FIG. 1 and 3, the first coupling member 406a extends distally at a particular distance from the proximal end 122a of the adaptor body 121, turns about 90 degrees, and extends inward toward the center axis C2 of the barrel body 112, resulting in a first extension piece 406a- 1 that extends in a direction generally parallel with the center axis C2 of the adaptor body 121 (e.g., along the x-axis of the coordinate axes of FIG. l) and a second extension piece 406a-2 that extends in a direction that is generally perpendicular to the center axis C2 of the adaptor body 121 (e.g., along the z-axis of the coordinate axes of FIG. 1), thereby defining a pocket 407a between the proximal end 122a of the adaptor body 121 and the second extension piece 406a-2. Similarly, the second coupling member 406b extends distally at a particular distance from the proximal end 122a of the adaptor body 121, turns about 90 degrees, and extends inward toward the center axis C2 of the adaptor body 121, resulting in a first extension piece 406b- 1 that extends in a direction generally parallel with the center axis C2 of the adaptor body 121 (e.g., along the x-axis of the coordinate axes of FIG. 1) and a second extension piece 406b-2 that extends in a direction that is generally perpendicular to the center axis C2 of the adaptor body 121 (e.g., along the z-axis of the coordinate axes of FIG. 1), thereby defining a pocket 407b between the proximal end 122a of the adaptor body 121 and the second extension piece 406b-2.

[0053] As depicted in FIG. 1, the first coupling member 406a and the second coupling member 406b are located opposite one another. However, this is merely illustrative, and other locations and spacing are contemplated and included within the scope of the present disclosure. Further, while the present embodiment includes a pair of coupling members (e.g., the first coupling member 406a and the second coupling member 406b), this is also merely illustrative. That is, other amounts of coupling members are also contemplated and included within the scope of the present disclosure.P-29545. W 001 -53516-301714

[0054] Additionally, the first adaptor port 121a- 1 and the second adaptor port 121b- 1 may extend adjacent to one another in a protruding fashion. In such embodiments, the first adaptor port 121 a- 1 may be defined by a first adaptor port column 424a and the second adaptor port 121b- 1 may be defined by a second adaptor port column 424b. The first adaptor port 121a- 1 and the second adaptor port 121b- 1 may include a reduced diameter neck region 426, within which an Ciring or similar sealing device 427, depicted in FIG. 3, may be positioned. As will be described in greater detail the sealing device 427, similar to sealing device 317, may assist in providing a fluid - tight seal when engaged with the collar 140, described in greater detail below.

[0055] The first receptacle 121a and the second receptacle 121b are configured to receive a vacuum vial 160 therein. For example, the vacuum vial 160 may be a VACUTAINER tube such as commercially available from BD. The vacuum vials 160 may be described in further detail below.

[0056] Referring now to FIGS. 1, 4 A, and 4B, the collar 140 is depicted. The collar 140 of the depicted embodiment is configured to receive and rotate to fluidically couple the first port 112a- 1 of the dual barrel syringe 110 to the first adaptor port 121a- 1 of the adaptor 120 and the second port 112b- 1 of the dual barrel syringe 110 to the second adaptor port 12 lb- 1 of the adaptor 120. In particular, the collar 140 may include an internal body 142 and an external housing 145. A portion of the collar 140, such as the external housing 145 or portion thereof may be rotatable relative to the internal body 142.

[0057] The internal body 142 may be formed of any suitable material, e.g., plastic, rubber, metal, glass, ceramic, etc., may define a first communication path 142a and a second communication path 142b. The first communication path 142a may include a first receiving port 142a- 1 at a first end and a second receiving port 142a-2 at an opposite end. The first receiving port 142a- 1 and the second receiving port 142a-2 may be sized to receive the first port column 314a and the first adaptor port column 424a to provide a fluid path therebetween, such as depicted in FIG. 6B. In embodiments, the sealing devices 317, 427 may seal against an internal wall 143 of the internal body 142 thereby preventing component material leakage. Similarly, the second communication path 142b may include a first receiving port 142b- 1 at the first end and a second receiving port 142b-2 at the opposite end. The first receiving port 142b- 1 and the second receiving port 142b-2 may be sized to receive the second port column 314b and the second adaptor port column 424b to provide a fluid path therebetween, such as depicted in FIG. 6B. In embodiments, the sealing devices 317, 427 may seal against an internal wall 143 of the internal body 142 thereby preventing component material leakage.P-29545. W 001 -53516-301715

[0058] The external housing 145 may be formed of any suitable material, e.g., plastic, rubber, metal, glass, ceramic, etc. The external housing 145 may circumscribe the internal body 142 and rotate relative thereto. For example, between the external housing 145 and the internal body 142 may be bearings 144, such as ball bearings, ring bearings, etc., or a sealing device, such as an O-ring. Though two bearings are depicted, any number of bearings may be included. T couple to quarter turn connectors 300 and 400, the external housing 145 includes a first quarter turn connector 450a at a first end and a second quarter turn connector 450b at a second end. The first quarter turn connector 450a and the second quarter turn connector 450b may include a plurality of tabs 452.

[0059] The tabs 452 may be generally formed by a wall 422 of the external housing 145, which houses the internal body 142. That is, the tabs 452 may generally extends radially outward from the wall 422. Each tab 452 is shaped and sized to be received and retained by the pair of coupling members 306a, 306b of quarter turn connector 300 or the coupling members 406a, 406b of quarter turn connector 450 when rotated relative to the quarter turn connector 300, 400. In embodiments, the tabs 452 may have a ramped profile. For example, each tab 452 may have a first thickness (e.g., as defined along the y-axis of the coordinate axes of FIG. 5A and 5B) at one or more first portions thereof, which gradually increases to a second thickness at one or more second portions thereof to allow for compressed holding of the tab 452 by a pair of coupling members within respective pockets thereof For example, the plurality of tabs may include a first adaptor engagement tab 452b- 1 to be engaged by the first adaptor coupling member 406a and a second adaptor engagement tab 452b-2 to be engaged by the second adaptor coupling member 406b. Similarly, the plurality of tabs may include a first barrel engagement tab 452a- 1 configured to be engaged by the first coupling member 306a and a second barrel engagement tab 452a-2 configured to be engaged by the second coupling member 306b. In some embodiments, extending from the tabs 452 may be a stopper projection 456, which may extend perpendicularly from the tabs 452. Each stopper projection 456 may be configured to engage with a corresponding coupling member. In some embodiments, the thickness of the tab 452 may increase toward the stopper projection 456 and decrease in a direction away from the stopper projection 456. Such increase toward the stopper projection 456 may increase sealing pressure as described in embodiments above.

[0060] Referring now to FIGS. 5A and 5B a vacuum vial 160, may include a storage portion 162 and a stopper end 164. The storage portion 162 may be a tube which is closed by the stopper end 164. As depicted in FIG. 6C, the stopper end 164 may include a piercable portionP-29545. W 001 -53516-301716165, which may be pierced by the piercing tool described above. The piercable portion may be a rubber plug or similar type material. A vacuum vial assembly 161 is shown in FIG. 5B. A vacuum vial assembly 161 may include two or more vacuum vials, such as a first vacuum vial 160a and a second vacuum vial 160b. In some aspects, the first vacuum vial 160a and the second vacuum vial 160b are arranged in a substantially longitudinally parallel arrangement. In embodiments, a fixture 170 may receive and hold the first vacuum vial 160a relative to the second vacuum vial 160b. For example, the fixture 170 may include a first receiving recess 170a for receiving the first vacuum vial 160a and a second receiving recess 170b for receiving the second vacuum vial 160b. In embodiments, the first receiving recess 170a and the second receiving recess 170b may fully encircle the first vacuum vial 160a and the second vacuum vial 160b, respectively, or only a portion thereof For example, the first vacuum vial 160a may snap laterally into the first receiving recess 170a and the second vacuum vial 160b may snap laterally into the second receiving recess 170b, as opposed to being longitudinally inserted. The first and second receiving recesses 170a, 170b may be sized to ensure a snug fit with the respective first and second vacuum vials 160a, 160b. Using such a fixture 170 may allow a user to hold and advance both the first vacuum vial 160a and the second vacuum vial 160b simultaneously into the adaptor 120.

[0061] Initially, the first vacuum vial 160a the second vacuum vial 160b each hold a first particulate material 101c and a second particulate material lOld, respectively. It is noted that particulate materials may also refer to powder materials. In embodiments, the first vacuum vial 160a and the second vacuum vial 160b may hold different powder constituent materials, and / or differing amounts. The powder materials may be powder precursors of a desired hydrogel, such as for use as a radiation spacer. Powder materials may include, but are not limited to albumin, polyethylenimine (PEI), an amine containing polyethylene glycol (PEG) or protein, an N- hydroxysuccinimide (NHS) ester component such as PEG-(SS)2, PEG-(SS)4, PEG-(SS)8, PEG- (SG)4, PEG-(SG)8, and / or the like. In some aspects, molecular weights of the PEG components may range from about 2,000 to about 100,000. The powder or particular material may be biodegradable and / or bioabsorbable. As used herein, “biodegradable” and / or “bioabsorbable” refers to a compound that can be absorbed by the surrounding or local tissue of a subject and / or degraded and absorbed by the tissue of the subject.

[0062] The powder or particulate material can be composed of various crosslinking substances of varying amounts, designed to allow the hydrogel to last a specific amount of time in situ before degrading. In aspects, the hydrogel components may be selected based on a degradation time that corresponds to the length of anticipated radiation therapy. In aspects theP-29545. W 001 -53516-301717 length of anticipated radiation therapy, and thus the targeted time for hydrogel degradation is up to 18 months, for example from the range of 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 merely a rough guide generally used to target appropriate formulation of the hydrogel.

[0063] In embodiments, each vacuum vial 160 is initially filled with respective powder material such as described above and evacuated and stoppered with the stopper end 164. The vacuum vial 160 may then be stored until ready to use. Each vacuum tube may be evacuated to a pressure less than atmospheric pressure. For example, the vacuum pressure may be chosen, when assembled to the dual barrel syringe 110 through adaptor 120 and collar 140, to be sufficient to draw the first diluent 101a or the second diluent 101b into the respective vacuum vial 160. That is, the vacuum may be sufficient to overcome frictional forces between the barrel body 112 and the plungers 114a, 114b. Desired initial pressure may be based on several factors such as the total volume within a vacuum tube, a volume of fluid needed to be drawn within the vacuum tube (which may be based on desired mixture consistency), etc. Boyle’s law may be used to calculate the vacuum pressure needed within the vacuum tube. For example, Boyle’s law is illustrated below:1P 17 — jk 17 totalvtotal1atmvhead

[0064] where Ptotcis the pressure within the vacuum tube, Vtotalis the total volume within the vacuum tube (accounting for stopper end 164 engagement), Patmis atmospheric pressure (in absolute, e.g., 760 mmHg), and Vheadis equal to Vtotal- Vdraw, where Vdrawis equal to the amount of fluid needed to hydrate the particulate material within the vacuum vial 160. Accordingly, the following formula may solve for Ptotc

[0065] As an non-limiting example, where Vtotaiis approximately 8 mL, Vdrawis approximately 6 mL, and Patmis 760 mmHg, the resulting initial vacuum pressure within the vacuum tube is 190 mmHg (abs), which converted to gauge pressure is - l l psig vacuum. However, it is noted that other pressures are contemplated and possible.

[0066] Turning now to FIGS. 6A-6E, an illustrative method of mixing constituent materials is depicted using the dual barrel syringe 110, the collar 140, and the adaptor 120 described above. FIG. 6 A illustrates the dual barrel syringe 110, the collar 140, and the adaptorP-29545. W 001 -53516-301718120 in spaced relationship with one another. FIG. 6B and 6C illustrate the collar 140 coupling the dual barrel syringe 110 to the adaptor 120. In such embodiments, the first and second ports 112a- 1, 112b- 1 (e.g., first and second port columns 314a, 314b are arranged within respective the first receiving ports 142a- l, 142b- 1 and the first and second adaptor port columns 424a, 424b are arranged within respective second receiving ports 142a-2, 142b-2. The seals 317, 427 may engage the internal walls 413 to provide a fluid tight seal therewith. The external housing 145 may be rotated, relative to the internal body 142 and respective ports, such as by a quarter turn to lock respective tabs 452a- 1, 452a-2, 452b- l, 452b-2 beneath respective coupling members 306a, 306b, 406a, 406b of the dual barrel syringe 110 and the adaptor 120, as depicted in FIG. 6C.

[0067] Once attached, the first vacuum vial 160a containing the first particulate material 101c may be positioned (e.g., advanced proximally) into the first receptacle 121a, thereby piercing the first vacuum vial 160a, such as with the first piercing needle 150a, and fluidically coupling the first barrel portion 112a to the first vacuum vial 160a. Similarly the second vacuum vial 160b containing the second particulate material lOld may be positioned (e.g., advanced proximally) into the second receptacle 121b, thereby piercing the second vacuum vial 160b, such as with the second piercing needle 150b, and fluidically coupling the second barrel portion 112b to the second vacuum vial 160b. In some embodiments, the first vacuum vial 160a and the second vacuum vial 160b may be positioned within the first receptacle 121a and the second receptacle 121b simultaneously, such as where the first vacuum vial 160a and the second vacuum vial 160b are mounted to the fixture 170 as described above. As illustrated in FIG. 6D, upon fluidically coupling the first vacuum vial 160a to the first barrel portion 112a and the second vacuum vial 160b to the second barrel portion 112b, the first diluent 101a is automatically caused to flow into the first vacuum vial 160a and the second diluent 101b is caused to automatically flow into the second vacuum vial 160b. That is, the vacuum pressure within the first vacuum vial 160a and the second vacuum vial 160b acts to draw the fluid constituent materials from the first barrel portion 112a and the second barrel portion 112b into the respective first vacuum vial 160a and the second vacuum vial 160b. As depicted, the first plunger 114a and the second plunger 114b are caused to move distally to advance the fluid into the respective vacuum vial 160a, 160b. Accordingly, user depression of the first plunger 114a and the second plunger 114b may not be needed, thereby simplifying mixing procedures. In embodiments, once the diluents have moved into the respective vacuum vials, the mixing apparatus 200 may then be agitated (e.g., shaken, swirled, or the like) to cause the component materials to swirl or otherwise move within the first vacuum vial 160a and the second vacuum vial 160b to cause the particulate materials and respective diluents to becomeP-29545. W 001 -53516-301719 thoroughly mixed resulting in a first combination 102a within the first vacuum vial 160a and a second combination 102b within the second vacuum vial 160b. In some embodiments, the force at which the first and second diluents 101a, 101b enter the first vacuum vial 160a and the second vacuum vial 160b may be of such turbulence as to cause thorough mixing without need for separate agitation of the mixing apparatus 200. In some embodiments, the plungers 114a, 114b may be repeatedly pulled and depressed to further mix the respective first and second combinations 102a, 102b. Once mixing is completed, which may be visually confirmed by a user, the plungers 114a, 114b may be withdrawn (partial withdrawal is depicted in FIG. 6E) to withdraw respective first and second combinations 102a, 102b back in to the respective first and second barrel portions 112a, 112b while keeping the respective first and second combinations 102a, 102b isolated from one another. In some embodiments, any remaining gas may be purged back into the first vacuum vial 160a and the second vacuum vial 160b through the collar 140 and adaptor 120. Once sufficiently combined and moved back into the respective first barrel portion 112a and the second barrel portion 112b, the collar 140 may be twisted (e.g., quarter turned in the opposite direction) to be removed along with the adaptor 120 and vacuum vials 160a, 160b.

[0068] For delivery and mixing of the first and second combinations 102a, 102b, the applicator 130 may now be connected to the dual barrel syringe 110. Turning now to FIGS. 1 and 7A-7D, in embodiments the applicator 130 has a proximal end 13 la that extends proximally (in the +x direction of the coordinate axes of FIG. 1) and a distal end 131b that extends distally (e.g., in the -x direction of the coordinate axes of FIG. 1). The applicator 130 generally includes a hub 131 and an elongate hollow stylet 148 that extends distally (e.g., in the -x direction of the coordinate axes of FIG. l) from hub 131. Referring to FIG. 7C, the hub 131 may include an inner portion 132a, defining a plurality of input ports 132a- 1, 132a-2 and an outer housing 132b which is rotatable relative to the inner portion 132a. For example, one or more hub bearings 133 may facilitate rotation of the outer housing 132b relative to the inner portion 132a. The hub 131 is configured for removable connection to the dual barrel syringe 110 via a corresponding quarter turn connector 500 such that, when connected, the first input port 132a- 1 of the applicator 130 is aligned and sealed with the first port 112a- 1 of the dual barrel syringe 110 and the second input port 132a-2 of the applicator 130 is aligned and sealed with the second port 112b- 1 of the dual barrel syringe 110, as described in greater detail herein.

[0069] The elongate hollow stylet 148 of the applicator 130 is configured to facilitate fluid communication with the plurality of ports 112a-l, 112b- 1 of the dual barrel syringe 110 so as to receive the first and second combinations 102a, 102b (resulting of mixing component materials)P-29545. W 001 -53516-301720 from the dual barrel syringe 110 and direct the first and second combinations 102a, 102b to the distal end 131b thereof for mixing and delivery, such as generally depicted in FIGS. 7A-7D.

[0070] Referring to FIG. 7B, in embodiments, the elongate hollow stylet 148 may be constructed, for example, of an outer elongate cannula 148a and an inner elongate cannula 148b. Between the outer elongate cannula 148a and the inner elongate cannula 148b may be a first material delivery lumen 148a- 1 and within the inner elongate cannula 148b may be a second material delivery lumen 148b- 1, depicted in FIG. 7B. Accordingly, the outer elongate cannula 148a and the inner elongate cannula 148b may define two separate flow paths such that materials flowing therethrough remain separate until mixed toward a distal end 131b of the applicator 130. The outer elongate cannula 148a may be fixedly coupled to the outer housing 132b, such as via adhesive, pressure fittings, overmolding, or the like. The inner elongate cannula 148b may be fixedly coupled to the inner portion 132a, such as via adhesive, pressure fittings, overmolding, or the like. Accordingly, in embodiments, rotation of the outer housing 132b relative to the inner portion 132a, causes the outer elongate cannula 148a to relate relative to the inner elongate cannula 148b.

[0071] The inner portion 132a of the hub 131 may further include a plurality of passageways therein for fluidly coupling the first input port 132a- 1 to the first material delivery lumen 148a- 1 and the second input port 132a-2 to the second material delivery lumen 148b- 1. For example, in some aspects, a first channel 134a may fluidically couple the first input port 132a-l to the first material delivery lumen 148a-l by extending through the inner portion 132a from the first input port 132a- l to the first material delivery lumen 148a- 1. In another example, a second channel 134b may couple the second input port 132b- 1 to the second material delivery lumen 148b- 1 by extending through the inner portion 132a from the second input port 132a-2 to the second material delivery lumen 148b-l . The positioning of the first channel 134a and the second channel 134b may be dependent on a location of the first input port 132a- 1 and the second input port 132a-2. For example, the first input port 132a-l and the second input port 132a-2 are spaced to be aligned with the ports 112a- 1, 112b-l of the dual barrel syringe 110. As such, the first input port 132a- 1 and the second input port 132a-2 are generally spaced the same distance radially outward from the center axis C3 of the applicator 130, depicted in FIG. 1.

[0072] Referring to FIGS. 1 and 7C, the corresponding quarter turn connector 500 of the applicator 130 may include two circular recesses 514a, 514b formed within the inner portion 132a for receiving the first port column 314a and the second port column 314b and sealing thereto, suchP-29545. W 001 -53516-301721 as via the seals 317. The quarter turn connector 500 may further include an applicator lip 554 extending radially outward from the outer housing 132b.

[0073] The applicator lip 554 is generally formed by a wall 553 of the outer housing 132b. That is, the applicator lip 554 generally extends radially outward from the wall 553. The applicator lip 554 is shaped and sized to be received and retained by the pair of coupling members 306a, 306b when the corresponding quarter turn connector 500 is rotated relative to the quarter turn connector 300, as described herein. In embodiments, the applicator lip 554 has a first thickness (e.g., as defined along the x-axis of the coordinate axes of FIG. 1) at one or more first portions thereof which gradually increases to a second thickness (e.g., as defined along the x-axis of the coordinate axes of FIG. 1) at one or more second portions thereof to allow for compressed holding of the applicator lips 554 by the pair of coupling members 306a, 306b within the pockets 307a, 307a thereof In some aspects, the applicator lip 554 may extend around an entire periphery of the wall 453. In other aspects, the applicator lip 554 may extend only around a portion of the periphery of the wall 553. In such aspects, a plurality of applicator lips may be used.

[0074] In some aspects, the corresponding quarter turn connector 500 further includes a pair of stopper projections 556 (only one is depicted in FIG. 7A). Each one of the pair of stopper projections 556 extends distally (e.g., in the +x direction of the coordinate axes of FIG. 1, toward the distal end 131b of the applicator 130) from the applicator lip 554. Each one of the pair of stopper projections 556 is aligned on the corresponding quarter turn connector 500 such that the pair of stopper projections 556 contact the coupling members 306a, 306b during a quarter turn rotating motion to hinder further rotational movement of the corresponding quarter turn connector 500 relative to the quarter turn connector 300 beyond a quarter rotation. It should be understood that any number of stopper projections may be used, though the number of stopper projections generally corresponds to the same number of coupling members (or less than the number of coupling members). For example, if the quarter turn connector 300 includes two coupling members 306a, 306b, the corresponding quarter turn connector 500 may include one stopper projection 556 or two stopper projections 556. In some aspects, the pair of stopper projections 556 may extend radially outward from the wall 553 and may not be connected to the applicator lip 554.

[0075] During a method of delivery of a radiation spacer, for example, such as after performing a method of mixing component materials described above, a user may assemble the applicator 130 to the dual barrel syringe 110. When assembled, inner portion 132a receives the first port column 314a within the first circular recess 514a and the second port column 314b withinP-29545. W 001 -53516-301722 the second circular recess 514b, depicted in FIG. 7B. The outer housing 132b may then be rotated to lock the applicator lips 554 to respective first and second coupling member 306a, 306b, as described above, depicted in FIG. 7C. Once locked in place, the plungers 114a, 114b may be advanced distally to cause the respective first and second combinations 102a, 102b flow out of the dual barrel syringe 110 (via pressure from plungers 114a, 114b) through hub 131 and the first material delivery lumen 148a- 1 and the second material delivery lumen 148b- 1. The first and second combinations 102a, 102b may then be allowed to combine at a target delivery site, as illustrated in FIG. 7D.

[0076] Embodiments of the present disclosure may be further described with respect to the following numbered clauses:

[0077] 1. A mixing syringe system comprising: a dual barrel syringe comprising a first barrel portion and a second barrel portion; a first vacuum vial; a second vacuum vial; andan adaptor attachable to the first barrel portion and the second barrel portion, the adaptor comprising a first receptacle for receiving the first vacuum vial and a second receptacle for receiving the second vacuum vial, the adaptor comprising a piercing tool for piercing and fluidically coupling the first vacuum vial to the first barrel portion and the second vacuum vial to the second barrel portion.

[0078] 2. The mixing syringe system of clause 1, wherein the first vacuum vial and the second vacuum vial are under vacuum pressure, and piercing the first vacuum vial and the second vacuum vial automatically causes fluid within the first barrel portion and the second barrel portion to enter the first vacuum vial and the second vacuum vial respectively.

[0079] 3. The mixing syringe system of any preceding clause, wherein each of the first barrel portion and the second barrel portion have a fluid port radially offset from a centerline of the first barrel portion and the second barrel portion.

[0080] 4. The mixing syringe system of any preceding clause, wherein the adaptor comprises a first adaptor port and a second adaptor port radially offset from a centerline of each of the first receptacle and the second receptacle.

[0081] 5. The mixing syringe system of any preceding clause, wherein the piercing tool comprises a first piercing needle positioned within the first receptacle and a second piercing needle positioned within the second receptacle.

[0082] 6. The mixing syringe system of any preceding clause, further comprising an applicator coupleable to the dual barrel syringe and comprising an outer elongate cannula and an inner elongate cannula.P-29545. W 001 -53516-301723

[0083] 7. A mixing syringe system comprising: a dual barrel syringe comprising a first barrel portion and a second barrel portion; a first vacuum vial; a second vacuum vial; an adaptor comprising a first receptacle for receiving the first vacuum vial and a second receptacle for receiving the second vacuum vial, the adaptor comprising a piercing tool for piercing and fluidically coupling the first vacuum vial to the first barrel portion and the second vacuum vial to the second barrel portion; and a collar configured to removably couple the dual barrel syringe to the adaptor.

[0084] 8. The mixing syringe system of clause 7, wherein the first vacuum vial and the second vacuum vial are under vacuum pressure, and piercing the first vacuum vial and the second vacuum vial automatically causes fluid within the first barrel portion and the second barrel portion to enter the first vacuum vial and the second vacuum vial respectively.

[0085] 9. The mixing syringe system of any preceding clause, wherein each of the first barrel portion and the second barrel portion have a fluid port radially offset from a centerline of the first barrel portion and the second barrel portion.

[0086] 10. The mixing syringe system of any preceding clause, wherein the adaptor comprises a first adaptor port and a second adaptor port radially offset from a centerline of each of the first receptacle and the second receptacle.

[0087] 11. The mixing syringe system of any preceding clause, wherein the piercing tool comprises a first piercing needle positioned within the first receptacle and a second piercing needle positioned within the second receptacle.

[0088] 12. The mixing syringe system of any preceding clause, further comprising an applicator coupleable to the dual barrel syringe and comprising an outer elongate cannula and an inner elongate cannula.

[0089] 13. The mixing syringe system of any preceding clause, wherein the collar defines a first communication path and a second communication path.

[0090] 14. A method of preparing a mixture of constituent materials for delivery with a mixing syringe system, the method comprising: coupling an adaptor to a dual barrel syringe, the dual barrel syringe comprising a first barrel portion housing a first diluent and a second barrel portion housing a second diluent, wherein the adaptor comprises a first receptacle, a second receptacle, and a piercing tool within both the first receptacle and the second receptacle; positioning a first vacuum vial containing a first particulate material under vacuum pressure into the first receptacle, thereby piercing the first vacuum vial and fluidically coupling the first barrel portion to the first vacuum vial; and positioning a second vacuum vial containing a secondP-29545. W 001 -53516-301724 particulate material under vacuum pressure into the second receptacle, thereby piercing the second vacuum vial and fluidically coupling the second barrel portion to the second vacuum vial, wherein fluidically coupling the first vacuum vial to the first barrel portion and the second vacuum vial to the second barrel portion automatically causes the first diluent to flow into the first vacuum vial and the second diluent to flow into the second vacuum vial.

[0091] 15. The method of clause 14, further comprising agitating the first vacuum vial and the second vacuum vial to mix the first diluent with the first particulate material and the second diluent with the second particulate material.

[0092] 16. The method of any preceding clause, wherein coupling the adaptor to the dual barrel syringe comprises coupling a collar to a distal end of the dual barrel syringe and a proximal end of the adaptor, the collar defining a first communication path and a second communication path.

[0093] 17. The method of any preceding clause, further comprising withdrawing a plunger positioned within the first barrel portion and the second barrel portion to pull resulting mixtures from the first vacuum vial into the first barrel portion and from the second vacuum vial into the second barrel portion.

[0094] 18. The method of clause 17, further comprising removing the adaptor from the dual barrel syringe and coupling an applicator to the dual barrel syringe, wherein the applicator comprises an outer elongate cannula and an inner elongate cannula.

[0095] 19. The method of clause 17 or 18, wherein positioning the first vacuum vial within the first receptacle causes a first piercing needle of the piercing tool to pierce the first vacuum vial.

[0096] 20. The method of clause 19, wherein positioning the second vacuum vial within the second receptacle causes a second piercing needle of the piercing tool to pierce the second vacuum vial.

[0097] It should now be understood that the present disclosure relates to various mixing syringe assemblies and methods of mixing constituent materials with mixing syringe assemblies. The various embodiments provided herein may provide ready to use or easily assembled syringe assemblies for easily mixing components. Moreover, embodiments as provided herein may assist in maintaining sterility and / or constituent material integrity, while improving ease of mixing and delivery.

[0098] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing fromP-29545. W 001 -53516-301725 the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

P-29545. W 001 -53516-301726CLAIMS1. A mixing syringe system comprising: a dual barrel syringe comprising a first barrel portion and a second barrel portion; a first vacuum vial; a second vacuum vial; and an adaptor attachable to the first barrel portion and the second barrel portion, the adaptor comprising a first receptacle for receiving the first vacuum vial and a second receptacle for receiving the second vacuum vial, the adaptor comprising a piercing tool for piercing and fluidically coupling the first vacuum vial to the first barrel portion and the second vacuum vial to the second barrel portion.

2. The mixing syringe system of claim 1, wherein the first vacuum vial and the second vacuum vial are under vacuum pressure, and piercing the first vacuum vial and the second vacuum vial automatically causes fluid within the first barrel portion and the second barrel portion to enter the first vacuum vial and the second vacuum vial respectively.

3. The mixing syringe system of claim 1, wherein each of the first barrel portion and the second barrel portion have a fluid port radially offset from a centerline of the first barrel portion and the second barrel portion.

4. The mixing syringe system of claim 1, wherein the adaptor comprises a first adaptor port and a second adaptor port radially offset from a centerline of each of the first receptacle and the second receptacle.

5. The mixing syringe system of claim 1, wherein the piercing tool comprises a first piercing needle positioned within the first receptacle and a second piercing needle positioned within the second receptacle.

6. The mixing syringe system of claim 1, further comprising an applicator coupleable to the dual barrel syringe and comprising an outer elongate cannula and an inner elongate cannula.

7. A mixing syringe system comprising: a dual barrel syringe comprising a first barrel portion and a second barrel portion;P-29545. W 001 -53516-301727 a first vacuum vial; a second vacuum vial; an adaptor comprising a first receptacle for receiving the first vacuum vial and a second receptacle for receiving the second vacuum vial, the adaptor comprising a piercing tool for piercing and fluidically coupling the first vacuum vial to the first barrel portion and the second vacuum vial to the second barrel portion; and a collar configured to removably couple the dual barrel syringe to the adaptor.

8. The mixing syringe system of claim 7, wherein the first vacuum vial and the second vacuum vial are under vacuum pressure, and piercing the first vacuum vial and the second vacuum vial automatically causes fluid within the first barrel portion and the second barrel portion to enter the first vacuum vial and the second vacuum vial respectively.

9. The mixing syringe system of claim 7, wherein each of the first barrel portion and the second barrel portion have a fluid port radially offset from a centerline of the first barrel portion and the second barrel portion.

10. The mixing syringe system of claim 7, wherein the adaptor comprises a first adaptor port and a second adaptor port radially offset from a centerline of each of the first receptacle and the second receptacle.11 . The mixing syringe system of claim 7, wherein the piercing tool comprises a first piercing needle positioned within the first receptacle and a second piercing needle positioned within the second receptacle.

12. The mixing syringe system of claim 7, further comprising an applicator coupleable to the dual barrel syringe and comprising an outer elongate cannula and an inner elongate cannula.

13. The mixing syringe system of claim 7, wherein the collar defines a first communication path and a second communication path.

14. A method of preparing a mixture of constituent materials for delivery with a mixing syringe system, the method comprising:P-29545. W 001 -53516-301728 coupling an adaptor to a dual barrel syringe, the dual barrel syringe comprising a first barrel portion housing a first diluent and a second barrel portion housing a second diluent, wherein the adaptor comprises a first receptacle, a second receptacle, and a piercing tool within both the first receptacle and the second receptacle; positioning a first vacuum vial containing a first particulate material under vacuum pressure into the first receptacle, thereby piercing the first vacuum vial and fluidically coupling the first barrel portion to the first vacuum vial; and positioning a second vacuum vial containing a second particulate material under vacuum pressure into the second receptacle, thereby piercing the second vacuum vial and fluidically coupling the second barrel portion to the second vacuum vial, wherein fluidically coupling the first vacuum vial to the first barrel portion and the second vacuum vial to the second barrel portion automatically causes the first diluent to flow into the first vacuum vial and the second diluent to flow into the second vacuum vial.

15. The method of claim 14, further comprising agitating the first vacuum vial and the second vacuum vial to mix the first diluent with the first particulate material and the second diluent with the second particulate material.

16. The method of claim 14, wherein coupling the adaptor to the dual barrel syringe comprises coupling a collar to a distal end of the dual barrel syringe and a proximal end of the adaptor, the collar defining a first communication path and a second communication path.

17. The method of claim 14, further comprising withdrawing a plunger positioned within the first barrel portion and the second barrel portion to pull resulting mixtures from the first vacuum vial into the first barrel portion and from the second vacuum vial into the second barrel portion.

18. The method of claim 17, further comprising removing the adaptor from the dual barrel syringe and coupling an applicator to the dual barrel syringe, wherein the applicator comprises an outer elongate cannula and an inner elongate cannula.

19. The method of claim 17, wherein positioning the first vacuum vial within the first receptacle causes a first piercing needle of the piercing tool to pierce the first vacuum vial.P-29545. W 001 -53516-30172920. The method of claim 19, wherein positioning the second vacuum vial within the second receptacle causes a second piercing needle of the piercing tool to pierce the second vacuum vial.

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