Mixing syringe systems and methods of mixing constituent materials

Abstract

A mixing syringe system includes a barrel assembly, a constituent material reservoir, and a connector housing. The barrel assembly includes a first barrel and a second barrel and defines a first fluid flow path and a second fluid flow path, wherein a portion of the first fluid flow path is within the second fluid flow path. The constituent material reservoir defines a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path. The connector housing couples the barrel assembly to the constituent material reservoir. The connector housing defines a first connector flow path and a second connector flow path. The first connector flow path fluidically couples the first fluid flow path to the first reservoir flow path, and the second connector flow path fluidically couples the second fluid flow path to the second reservoir flow path.

Description

MIXING SYRINGE SYSTEMS AND METHODS OF MIXING CONSTITUENT MATERIALSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the priority to U.S. Provisional Patent Application No. 63 / 509,157, filed June 20, 2023, and entitled “MIXING SYRINGE ASSEMBLIES AND METHODS OF MIXING CONSTITUENT MATERIALS,” the entirety of which is incorporated by reference here.BACKGROUNDField

[0002] The present disclosure generally relates to mixing syringe systems and methods of mixing constituent materials and, more particularly, mixing syringe assemblies and methods of mixing constituent materials for radiation spacers.Technical Background

[0003] 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.

[0004] 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.SUMMARY

[0005] Embodiments of the present disclosure are directed to various mixing syringe systems, which may maintain separation of constituent materials until time for use of the mixed constituent materials. Embodiments are also directed to method of mixing constituent materials using the mixing syringe assemblies as described herein.

[0006] In one embodiment, a mixing syringe system for mixing constituent materials may include a barrel assembly, a constituent material reservoir, and a connector housing. The barrelassembly includes a first barrel and a second barrel and defines a first fluid flow path from the first barrel and a second fluid flow path from the second barrel, wherein at least a portion of the first fluid flow path is located within the second fluid flow path. The constituent material reservoir includes a first storage portion and a second storage portion and defines a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path. The connector housing is configured to couple the barrel assembly to the constituent material reservoir. The connector housing defines a first connector flow path and a second connector flow path. The first connector flow path fluidically couples the first fluid flow path to the first reservoir flow path, and the second connector flow path fluidically couples the second fluid flow path to the second reservoir flow path.

[0007] In another embodiment, a mixing syringe system for mixing constituent materials may include a barrel assembly, a constituent material reservoir, a connector housing, and an applicator configured to be removably coupled to the barrel assembly. The barrel assembly includes a first barrel and a second barrel and defines a first fluid flow path from the first barrel and a second fluid flow path from the second barrel, wherein at least a portion of the first fluid flow path is located within the second fluid flow path. The constituent material reservoir includes a first storage portion and a second storage portion and defines a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path. The connector housing is configured to couple the barrel assembly to the constituent material reservoir. The connector housing defines a first connector flow path and a second connector flow path. The first connector flow path fluidically couples the first fluid flow path to the first reservoir flow path, and the second connector flow path fluidically couples the second fluid flow path to the second reservoir flow path.

[0008] In yet another embodiment, a method of mixing constituent materials includes coupling a barrel assembly to a constituent material reservoir. The barrel assembly includes a first barrel and a second barrel and defines a first fluid flow path from the first barrel and a second fluid flow path from the second barrel, wherein at least a portion of the first fluid flow path is located within the second fluid flow path. The constituent material reservoir includes a first storage portion and a second storage portion and defines a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path. The method further includes advancing a first plunger through the barrel assembly to advance a first diluent within the first barrel through the first fluid flow path and into the first storage portion to mix the first diluent with a first powder within the first storage portion.

[0009] 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.

[0010] 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

[0011] 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:

[0012] FIG. 1A schematically depicts a syringe assembly, according to one or more embodiments shown and described herein;

[0013] FIG. IB schematically illustrates a spacer removed from the syringe assembly of FIG. 1 A, according to one or more embodiments shown and described herein;

[0014] FIG. 1C schematically illustrates a cross-section of the syringe assembly of FIG. IB, according to one or more embodiments shown and described herein;

[0015] FIG. ID schematically illustrates a cross-section of the syringe assembly of FIG. 1C moved to a engaged configuration, according to one or more embodiments shown and described herein;

[0016] FIG. 2 schematically depicts a barrel cap coupled to the barrel assembly of FIGS. 1 A-1D, according to one or more embodiments shown and described herein;

[0017] FIG. 3 schematically depicts a reservoir cap coupled the constituent material reservoir of FIGS. 1 A-1D, according to one or more embodiments shown and described herein;

[0018] FIG. 4A schematically depicts an applicator coupled to the barrel assembly of FIGS. 1 A-1D, to provide an applicator assembly, according to one or more embodiments shown and described herein;

[0019] FIG. 4B schematically depicts a cross-section of the applicator assembly of FIG. 4A, according to one or more embodiments shown and described herein;

[0020] FIG. 5 A schematically depicts a perspective view of a barrel assembly, according one or more embodiments shown and described herein;

[0021] FIG. 5B schematically depicts a front view of the barrel assembly of FIG. 5A, according to one or more embodiments shown and described herein;

[0022] FIG. 5C schematically depicts a cross-sectional view of the barrel assembly of FIG. 5 A, according to one or more embodiments shown and described herein;

[0023] FIG. 6A schematically depicts a barrel cap connected to a distal end of the barrel assembly of FIGS. 5A-5C, according to one or more embodiments shown and described herein;

[0024] FIG. 6B schematically depicts a cross-sectional view of the barrel cap and the distal end of the barrel assembly of FIG. 6A, according to one or more embodiments shown and described herein;

[0025] FIG. 7A schematically depicts a perspective view of a constituent material reservoir, according to one or more embodiments shown and described herein;

[0026] FIG. 7B schematically depicts a front view of the constituent material reservoir of FIG. 7A, according to one or more embodiments shown and described herein;

[0027] FIG. 7C schematically depicts a cross section of a proximal end of the constituent material reservoir of FIG. 7A, according to one or more embodiments shown and described herein;

[0028] FIG. 8A schematically depicts a reservoir cap connected to a distal end of the constituent material reservoir of FIGS. 7A-7C, according to one or more embodiments shown and described herein;

[0029] FIG. 8B schematically depicts a cross-sectional view of the reservoir cap and the distal end of the constituent material reservoir of FIG. 8A, according to one or more embodiments shown and described herein;

[0030] FIG. 9A schematically depicts a perspective view of an applicator, according to one or more embodiments shown and described herein;

[0031] FIG. 9B schematically depicts a cross section of the applicator of FIG. 9A, according to one or more embodiments shown and described herein;

[0032] FIG. 10A schematically depicts the barrel assembly with barrel cap of FIGS. 6A and 6B aligned with the constituent material reservoir and reservoir cap of FIGS. 8A and 8B, according to one or more embodiments shown and described herein;

[0033] FIG. 10B schematically depicts the barrel assembly and constituent material reservoir of FIG. 10A with the barrel cap and the reservoir cap removed, according to one or more embodiments shown and described herein;

[0034] FIG. 10C schematically depicts the barrel assembly and the constituent material reservoir of FIG. 10B connected to one another to provide a mixing syringe assembly, according to one or more embodiments shown and described herein;

[0035] FIG. 10D schematically depicts a cross-section of the mixing syringe assembly of FIG. 10C, according to one or more embodiments shown and described herein;

[0036] FIG. 10E schematically depicts flow paths through the mixing syringe assembly of FIG. 10D in a first direction, according to one or more embodiments shown and described herein;

[0037] FIG. 10F schematically depicts flow paths through the mixing syringe assembly in an second, opposite direction of FIG. 10D, according to one or more embodiments shown and described herein;

[0038] FIG. 10G schematically depicts a cross section of the barrel assembly of FIG. 5 A aligned is the applicator of FIG. 9A, according to one or more embodiments shown and described herein;

[0039] FIG. 10H schematically depicts a cross section of the applicator of FIG. 10G coupled to the barrel assembly to provide an applicator assembly, according to one or more embodiments shown and described herein;

[0040] FIG. 101 schematically depicts another cross section of the applicator of FIG. 10H, according to one or more embodiments shown and described herein; and

[0041] FIG. 10J schematically depicts delivery of a radiation spacer with the applicator of FIG. 101, according to one or more embodiments shown and described herein.DETAILED DESCRIPTION

[0042] The present disclosure is generally directed to mixing syringe systems for mixing and / or delivering at least two constituent materials. Moreover, particularly the present application is directed to mixing syringe systems configured for delivering a radiation spacer. 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, powder components may need to be kept dry or unconstituted prior to application. However, during use, powder components 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. Embodiments of the present disclosure may provide constituent materials in prepackaged, premeasured, ready-to use syringe systems, which, as will be described in greater detail herein, maintains sterility and / or improves mixing and / or delivery.

[0043] In particular embodiments, liquid constituent materials may be contained within a barrel assembly while powder components may be contained within a constituent material reservoir. When mixing is desired, the barrel assembly and the constituent material reservoir may be brought together. A connector housing may connect the barrel assembly and the constituent material reservoir. In embodiments, the barrel assembly may include a first barrel and a second barrel and define a first fluid flow path from the first barrel and a second fluid flow path from the second barrel. In embodiments, at least a portion of the first fluid flow path is located within the second fluid flow path. Such may allow for a lower profile delivery end for more compact components. Additionally, as will be discussed further below, in particular embodiments, luer type connectors are used to allow for connection of standard components as well as seamlessly transition between various components of the assemblies described herein.

[0044] 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. The directional term “proximal” generally refers to directions away from point of origin such as toward a handle. The directional term “distal” generally refers to directions away from a point of origin such as toward a tip of a device.

[0045] 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 to 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 to 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.

[0046] 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. As used herein, the term “and / or” refers to inclusion of one or more referents. For example, A and / or B would be inclusive of embodiments including A only, B only, or both A and B.

[0047] Turning now to the drawings, FIG. 1 A depicts one or more components of a mixing syringe system 10. The mixing syringe system 10 may be used for combining two or more constituent materials as will be described in greater detail herein. In particular, the mixing syringe system 10 may be used to mix or combine two or more constituent components of a hydrogel for use as a radiation spacer. The mixing syringe system 10 generally includes a barrel assembly 100, a constituent material reservoir 200, and a connector 300. It is noted that a mixing syringe system 10 may include a greater or fewer number of components without departing from the scope of the present disclosure. For example, and as will be described in greater detail below, the mixing syringe system 10 may also include an applicator 700 (depicted in FIGS. 4A and 4B, for example). The various components as provided herein may be formed of any suitable materials such as glass, plastic, metal, etc.

[0048] The barrel assembly 100 includes a first barrel 110a and a second barrel 110b, however it is contemplated that the barrel assembly 100 may include any number of barrels, such as one or more, two or more, etc. In embodiments, the barrel assembly 100 includes a barrel body105 which defines the first barrel 110a and the second barrel 110b. That is, the first barrel 110a and the second barrel 110b may be integral with one another. In other embodiments, the first barrel 110a and the second barrel 110b may be coupled to one another such as via, welding, adhesives, fasteners, brackets, etc. Each of the first barrel 110 and second barrel 110b define an internal volume I l la, 111b which may receive a plunger 102a, 102b. That is, the barrel body 105 may define two hollow voids providing separate internal volumes I l la, 111b, also depicted in FIGS. 1C and ID.

[0049] Still referring to FIG. 1 A, the barrel assembly 100 may have a proximal end 113a which provides an opening into each of the respective internal volumes I l la, 11 lb for receiving the plungers 102a, 102b. At a distal end 113b opposite the proximal end 113a the barrel body 105 may include a fluid directing portion 112, which provides flow paths to or from the respective internal volumes I l la, 11 lb. Such fluid flow paths will be described in greater detail below. The fluid directing portion 112 may be integral with or coupled (via any coupling technique such as welding, fasteners, interlocks, etc.) to the first barrel 110a and the second barrel 110b.

[0050] Still referring to FIG. 1A, the plungers 102a, 102b may be slidably disposed, respectively, in the first barrel 110a and the second barrel 110b of the barrel body 105 and may form a fluidic seal with the barrel body 105 via a seal at a distal end of each plunger 102a, 102b. For example, the seal may be a rubber or similar material conformable material for forming a fluid-tight seal with the first barrel 110 or the second barrel 110b. The plungers 102a, 102b may be separately actuatable or may be rigidly coupled to one another such that they are actuated simultaneously when either is pushed / pulled in along a longitudinal axis.

[0051] In embodiments, the first barrel 110a and the second barrel 110b may originally hold liquid constituent materials for dissolving or suspending powder / particulates described in greater detail below. Liquid constituent materials may include saline, water, deionized water, or the like. In some embodiments, the liquid constituent material may be a liquid albumin. Accordingly, the first barrel 110a may hold a first diluent and the second barrel 110b may hold a second diluent. The first diluent and the second diluent may be the same or different and / or have the same or different volumes.

[0052] The constituent material reservoir 200 includes a first storage portion 210a and a second storage portion 210b, however it is contemplated that the constituent material reservoir 200 may include any number of storage portions, such as one or more, two or more, etc. In embodiments, the constituent material reservoir 200 includes a reservoir body 205 which definesthe first storage portion 210a and the second storage portion 210b. That is, the first storage portion 210a and the second storage portion 210b may be integral with one another. In other embodiments, the first storage portion 210a and the second storage portion 210b may be coupled to one another such as via, welding, adhesives, fasteners, brackets, etc. Each of the first storage portion 210a and the second storage portion 210b define an internal volume 211a, 211b which may receive a plunger 202a, 202b. That is, the reservoir body 205 may define two hollow voids providing separate internal volumes 211a, 21 lb, depicted in FIGS. 1C and ID.

[0053] Still referring to FIG. 1A, the constituent material reservoir 200 may have a proximal end 213a which provides an opening into each of the respective internal volumes 211a, 211b for receiving the plungers 202a, 202b. At a distal end 213b opposite the proximal end 213a the reservoir body 205 may include a directing portion 212, which provides flow paths to or from the respective internal volumes 211a, 211b. Such fluid flow paths will be described in greater detail below. The directing portion 212 may be integral with or coupled (via any coupling technique such as welding, fasteners, interlocks, etc.) to the first storage portion 210a and the second storage portion 210b.

[0054] Still referring to FIG. 1, the plungers 202a, 202b may be slidably disposed, respectively, in the first storage portion 210a and the second storage portion 210b of the reservoir body 205 and may form a fluidic seal with the reservoir body 205 via a seal at a distal end 113b of each plunger 202a, 202b. For example, the seal may be a rubber or similar material conformable material for forming a fluid-tight seal with the first barrel 110 or the second barrel 110b. The plungers 202a, 202b may be separately actuatable or may be rigidly coupled to one another such that they are actuated simultaneously when either is pushed / pulled in along a longitudinal axis. In some embodiments, the constituent material reservoir 200 may not include plungers 202a, 202b. However, inclusion of plungers 102a may assist with mixing and moving material between the constituent material reservoir 200 and the barrel assembly 100.

[0055] In embodiments, the first storage portion 210a and the second storage portion 210b may initially hold / store the powder constituent materials noted above. The powder constituent material may be a microparticles such as a powder or particulate material, such as but 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. For example, the first storage portion210a may hold sodium carbonate or other pH adjustment agent and the second storage portion 210b may hold PEG-(SG)8 20,000 MW. 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.

[0056] 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 the 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.

[0057] As will be described in greater detail here, the connector 300 is configured to couple the barrel assembly 100 to the constituent material reservoir 200. As will be described with reference to the further figures, the connector 300 may include a connector housing 302 that defines separate connector 300 flow paths for fluidically coupling the first barrel 110 to the first storage portion 210a and the second barrel 110b to the second storage portion 210b. In embodiments, the connector housing 302 may be removably coupled to the barrel assembly 100 and / or the constituent material reservoir 200.

[0058] In some embodiments, and as depicted in FIG. 1 A, the barrel assembly 100 and the constituent material reservoir 200 may be initially assembled with the connector 300 but not yet fluidically coupled. For example, the connector 300 may include a spacer 325, which may be positioned between connector housing 302 and the proximal end 213a of the constituent material reservoir 200 to maintain a degree of separation (i.e., a spaced relationship) between the constituent material reservoir 200 and the connector housing 302 until fluidic communication and engagement are desired. In some embodiments, there may not be a spacer 325 and instead components may simply be kept disassembled until mixing is desired. For example, FIG. IB depicts the spacer 325 removed from the mixing syringe system 10. In some embodiments, and as will be described in greater detail herein, caps may be used to close the respective distal ends113b, 213a of the barrel assembly 100 and the constituent material reservoir 200 until use. Such may assist in preventing constituent material degradation within the constituent material reservoir 200 and / or the barrel assembly 100.

[0059] FIG. 1C and ID illustrate a longitudinal cross-section of the mixing syringe system 10 of FIG. of FIG. 2A in a disengaged configuration (FIG. 1C) and an engaged configuration (FIG. ID), respectively.

[0060] As noted above, the fluid directing portion 112 provides flow paths to or from the respective internal volumes I l la, 111b of the first barrel 110a and the second barrel 110b respectively. The fluid directing portion 112 may define the first fluid flow path 114a from the first barrel 110a and the second fluid flow path 114b from the second barrel 110b. At least a portion 520’ of the first fluid flow path 114a is located within the second fluid flow path 114b. For example, each of the first fluid flow path 114a and the second fluid flow path 114b may direct fluid toward a centerline Cl of the barrel assembly 100. About the centerline Cl of the barrel assembly 100 the first fluid flow path 114a may become located within the second fluid flow path 114b while remaining isolated therefrom (e.g., fluids do not mingle). That is, at least a portion of the first fluid flow path 114a is located within the second fluid flow path 114b.

[0061] In this particular embodiment, a first portion 115a of the first fluid flow path 114a may be formed within or at least partially by a first body portion 112a of the fluid directing portion 112. A second portion 115b of the first fluid flow path 114a may be provided by an elongate tube 117 (e.g., a tube, cannula, or the like). That is, the elongate tube 117 may form part of the first fluid flow path 114a. The elongate tube 117 may be coupled to the first body portion 112a such as within the first portion 115a of the first fluid flow path 114a and provide the second portion 115b of the first fluid flow path 114a therethrough. In embodiments, the elongate tube 117 may be press-fit, adhered, or the like to the first body portion 112a. The elongate tube 117 may be formed of any suitable material to maintain fluid stream separation such as metal, plastic, or the like.

[0062] A first portion 116a of the second fluid flow path 114b may also be formed within the first body portion 112a of the fluid directing portion 112. A second portion 116b of the second fluid flow path 114b may be formed within a second body portion 112b of the fluid directing portion 112 coupled to, such as directly coupled to (e.g., via adhesives, interlocks, fasteners, welding, or the like), the first body portion 112a. That second portion 116b of the second fluid flow path 114b may be provided by a tubular cavity through the second body portion 112b. Insuch embodiments, the elongate tube 117 may positioned within and extend through the second portion 116b of the second fluid flow path 114b. For example, the elongate tube 117 may be positioned concentrically within the second portion 116b of the second fluid flow path 114b. Accordingly, fluid may flow through the second portion 116b of the second fluid flow path 114b around an outer surface of the elongate tube 117. In embodiments, the elongate tube 117 may extend distally beyond an end of the second body portion 112b.

[0063] In embodiments, the fluid directing portion 112, such as the second body portion 112b, may include a mounting structure 140. For receiving and coupling to various components of the mixing syringe system 10. For example, and as shown, the mounting structure 140 may be a luer or threaded connector that receives and couples to the connector 300. For example, the connector housing 302 may include a connecting end 320 configured to be received within and threadingly engage the mounting structure 140. In embodiments and to prevent fluid leakage, the fluid directing portion 112, such as the second body portion 112b, may include an extending wall 120 that extends concentrically within the mounting structure 140 to separate the mounting structure 140 from the second fluid flow path 114b. That is when the connecting end 320 of the connector 300 is received within the mounting structure 140, the connecting end 320 is positioned between the extending wall 120 and the mounting structure 140. For example, the mounting structure 140 and the extending wall 120 may provide a luer type fitting, such as a male portion of a luer fitting which receives and threadingly couples to a female luer fitting provided by the connecting end 320 of the connector 300. The extending wall 120 may engage an inner surface of the mounting end 320 to provide a fluidic seal therewith. Other connecting structure are contemplated and possible. For example, a press fit, or any combination of pins or other type fasteners are contemplated and possible.

[0064] Referring briefly to FIG. 2, the connector 300 may not be initially coupled to the barrel assembly 100. Instead, a barrel cap 400 may be coupled to the barrel assembly 100, which may prevent material leakage and maintain sterility until mixing is desired. The barrel cap 400 may include a barrel cap connecting end 410 which may be coupled to the mounting structure 140. For example, the barrel cap connecting end 410 may include a female luer connector which may threadingly engage with the male luer connector of the mounting structure 140 while receiving the extending wall 120. The barrel cap 400 may include a tube receiving recess 420, which may receive the elongate tube 117 may seal against or otherwise prevent leakage from a distal end of the elongate tube 117. In embodiments, the barrel cap 400 may include a sealing device 430, such as an O-ring, which may seal against an outer surface of the elongate tube 117to further prevent fluid leakage around the outer surface of the elongate tube 117 when positioned within the sealing recess 420. When it is desired to mix constituent materials, the barrel cap 400 may be removed from the barrel assembly 100.

[0065] Still referring to FIGS. 1C and ID, the constituent material reservoir 200, such as the reservoir body 205, may also include a directing portion 212, which provides flow paths to or from the respective internal volumes 211a, 211b. The directing portion 212 may define the first reservoir flow path 214a from the first storage portion 210a and the second reservoir flow path 214b from the second storage portion 210b. The first reservoir flow path 214a and the second reservoir flow path 214b may be offset from one another as depicted, such that the first reservoir flow path 214a and the second reservoir flow path 214b do not share a common space. Accordingly, and as depicted, while both the first reservoir flow path 214a and the second reservoir flow path 214b may direct fluid toward the depicted centerline Cl, only one (e.g., the first reservoir flow path 214a) is depicted as being concentric with and extending along the centerline Cl. In some embodiments, and as depicted, a seal 215a, 215b (e.g., a rubber, foil, or other seal) may be located at a distal end 113b of the first reservoir flow path 214a and the second reservoir flow path 214b, which may assist in maintaining sterility and freshness of the powdered constituent materials within the respective first storage portion 210a and the second storage portion 210b.

[0066] As noted above, the connector 300 may include the connector housing 302 that defines separate connector 300 flow paths for fluidically coupling the first barrel 110a to the first storage portion 210a and the second barrel 110b to the second storage portion 210b. As illustrated in FIGS. 1C and ID, for example, the connector housing 302 may define a first connector flow path 314a and a second connector flow path 314b. The first connector flow path 314a may be fluidically coupled to the first fluid flow path 114a and the second connector flow path 314b may be fluidically coupled to the second fluid flow path 114b. For example, when assembled to the barrel assembly 100, the elongate tube 117 may be received within the first connector flow path 314a. As depicted, at least a portion of the second connector flow path 314b may surround the elongate tube 117 and receives flow from the second fluid flow path 114b. In embodiments, the connector 300 may include a seal 330 (such as an O-ring) which seals against an outer surface of the elongate tube 117 to prevent fluid leakage between the first connector flow path 314a and the second connector flow path 314b. Accordingly, and as depicted, a portion of the first connector flow path 314a and the second connector flow path 314b may extend concentrically about the centerline Cl. That is, a portion of the first connector flow path 314a and the second connectorflow path 314b may be coaxial with on another. However, in the depicted embodiment, the flow along the centerline Cl of the second connector flow path 314b may be diverted from extending along the centerline Cl to be radially offset from the centerline Cl or otherwise offset from one another. In embodiments, the first connector flow path 314a may be concentric with the centerline Cl along its entire length.

[0067] In embodiments, at a distal end 113b of each of the first connector flow path 314a and the second connector flow path 314b may be a first needle 316a and a second needle 316b. The first and second needles 216a, 216b may extend to pointed ends which may be configured to pierce the first seal 215a and the second seal 215b respectively. The first needle 216a and the second needle 216b may be press fit or otherwise affixed to the connector housing 302 and extend the first connector flow path 314a and the second connector flow path 314b therethrough. The first needle 316a and the second needle 316b may be formed of any suitable material such as plastic, metal, or the like.

[0068] As depicted in FIG. ID, when moved to an engaged configuration with the constituent material reservoir 200, the first connector flow path 314a fluidically couples the first fluid flow path 114a to the first reservoir flow path 214a and the second connector flow path 314b fluidically couples the fluid flow path to the second reservoir flow path 214b. For example, the first needle 216a may pierce the first seal 215a and the second needle 216b may pierce the second seal 215b thereby providing a continuous flow path between the first barrel 110 and the first storage portion 210a and the second barrel 110b and the second storage portion 210b.

[0069] Referring briefly to FIG. 3, in some embodiments, connector 300 may be provided coupled to the constituent material reservoir 200. For example, the connector housing 302 may be rigidly coupled to the connector 300 such as via adhesive, welding, fasteners, or the like. In such embodiments, the connector 300 may or may not include the first needle 216a and the second needle 216b. Similarly, the connector 300 constituent material reservoir 200 may or may not include the first seal 215a and the second seal 215b. In some embodiments, the connector 300 may be coupled to the constituent material reservoir 200 via a slide arrangement or similar structure to allow movement of the components relative to one another. As depicted, to seal 215a unwanted or inadvertent material flow from the constituent material reservoir 200, a reservoir cap 500 may be included. In the depicted embodiment, the reservoir cap 500 couples to an end of the connector 300 opposite the constituent material reservoir 200. The reservoir cap 500 may include a cap connector 510 which may receive the connecting end 320 of the connector 300 and becoupled thereto. For example, the cap connector 510 may receive and threadingly couple to the connecting end 320 of the connector 300. The reservoir cap 500 may have an extending portion 520 that is received into the first connector flow path 314a and seals against the seal 330 within the first connector flow path 314a. By coupling to the connecting end 320 the reservoir cap 500 seals both the first connector flow path 314a and the second connector flow path 314b.

[0070] Referring again to FIG. ID, when fluidically coupled, the first constituent materials within the respective first and second barrels 110a, 110b may be advanced (e.g., via actuation of the plunger 102a, 102b of the barrel assembly 100) along the first and second fluid flow paths 114a. 114b, respectively, into the first and second connector flow paths 314a, 314b, and then through the first and second reservoir flow paths 214a, 214b to mix with second (e.g., powdered) constituent materials within the first and second storage portions 210a, 210b. The mixing syringe assembly 210 may then be agitated (e.g., shaken) to mix the first and second constituent materials. In some embodiments, the any of the plungers 102a, 102b, 202a, 202b may be pushed or pulled to further assist in in mixing. After mixing, the resulting solutions in the first storage portion 210a and the second storage portion 210b of the constituent material reservoir 200 may be passed back into the syringe assembly 210 (or in some embodiments kept in the constituent material reservoir 200).

[0071] As noted above, the now combined constituent materials may be withdrawn or forced back into the barrel assembly 100 (such as via actuation of plungers 102a, 102b, 202a, and / or 202b). In this state, the connector 300, e.g., along with the constituent material reservoir 200, may be detached from the barrel assembly 100. Referring now to FIG. 4A and 4B, an applicator 700 may be coupled, such as removably coupled, to the barrel assembly 100 to provide an applicator assembly 20. For example, the applicator 700 may mount to the mounting structure 140 described above. In other embodiments it is contemplated that the applicator 700 could instead attach to the constituent material reservoir 200.

[0072] Still referring to FIGS. 4A and 4B, the applicator 700 may include an applicator body 710 which includes a mounting end 720 for being coupled to the mounting structure 140. For example, the mounting end 720 may be received within and threadingly engage the mounting structure 140 (though other coupling techniques are contemplated and possible). In such embodiments, the extending portion 120 may engage and seal against an innersurface of the mounting end 720. In embodiments, in embodiments, the mixtures within the first barrel 110 and the second barrel 110b may need to maintain separation until delivery at a desired location withina body. For example, the material may gel on contact, which may make delivery difficult if separation is not maintained. Accordingly, the applicator 700 may also define a first applicator flow path 714a and a second applicator flow path 714b. The first fluid flow path 114a may be fluidically coupled to the first applicator flow path 714a and the second fluid flow path 114b may be fluidically coupled to the second applicator flow path 714b. One or more portions of the first applicator flow path 714a and the second applicator flow path 714b may be, when mounted to the barrel assembly 100, concentric with the centerline Cl. In embodiments, the first applicator flow path 714a may include an applicator seal 730 (e.g., an O-ring), which seals against an outer surface of the elongate tube 117. The second fluid flow path 714b may direct fluid along the outer surface of the elongate tube 117. Coupled to the applicator body 710 may be an inner delivery tube 702a and an outer delivery tube 702b, wherein the inner delivery tube 702a is positioned within, such as concentrically within, the outer delivery tube 702b. The inner delivery tube 702a is fluidically coupled to the first applicator flow path 714a and the outer delivery tube 702b is fluidically coupled to the second applicator flow path 714b. Accordingly, when the plungers 102a, 102b are advanced, the mixed material within the first barrel 110 advance through the first fluid flow path 114a, the first applicator flow path 714a, and the inner delivery tube 702a. Similarly, the mixed material within the second barrel 110b is advanced through the second fluid flow path 114b, the second applicator flow path 714b, and the outer delivery tube 702b.

[0073] Referring now to FIG. 5A-5C another embodiment of a barrel assembly 100’ is generally depicted. The barrel assembly 100’ is substantially similar to the barrel assembly 100 described above. Accordingly, description of the barrel assembly 100 applies equally to the present embodiment unless otherwise noted or apparent. Additionally, similar components are labeled similarly but include an following the reference numeral. Accordingly, the barrel assembly 100’ may include a first barrel 110a’ and a second barrel 110b’ that define separate internal volumes I l la’, 111b’. Plungers 102a’, 102b’ may be positioned within the internal volumes 1 I la’, 11 lb’ for pushing / pulling fluid into / out of the internal volumes 1 I la’, 111b’. At a distal end 113b’ opposite a proximal end 113a’ of the barrel body 105’ may be a fluid directing portion 112’, which provides flow paths to or from the respective internal volumes 1 I la’, 111b’.

[0074] Referring specifically to FIG. 5C, the fluid directing portion 112’ somewhat differs from the fluid directing portion 112 described above. The fluid directing portion 112’ defines a first fluid flow path 114a’ from the first barrel 110a’ and the second fluid flow path 114b’ from the second barrel 110b’. At least a portion 520’ of the first fluid flow path 114a’ is located within the second fluid flow path 114b’. For example, each of the first fluid flow path 114a’ and thesecond fluid flow path 114b’ may direct fluid toward a centerline Cl’ of the barrel assembly 100. About the centerline Cl’ of the barrel assembly 100’ the first fluid flow path 114a’ may become located within the second fluid flow path 114b while remaining isolated therefrom (e.g., fluids do not mingle).

[0075] In this particular, embodiment, a first portion 115a’ of the first fluid flow path 114a’ may be formed within or at least partially by a first body portion 112a’ of the fluid directing portion 112 and a second portion 115b’ of the first fluid flow path 114a may be provided by the elongate tube 117’ (e.g., a tube, cannula, or the like). The elongate tube 117’ may be coupled to the first body portion 112a’ such as within the first portion 115a’ of the first fluid flow path 114a’ and provide the second portion 115b’ of the first fluid flow path 114a there through. As in embodiments above, the elongate tube 117’ may be press-fit, adhered, or the like to the first body portion 112a’.

[0076] A first portion 116a’ of the second fluid flow path 114b’ may also be formed within the first body portion 112a’ of the fluid directing portion 112. A second portion 116b of the second fluid flow path 114b may be formed within a second body portion 112b’ of the fluid directing portion 112. In the depicted embodiment, the second body portion 112b’ is integrally formed with the first body portion 112a’, but may instead be coupled to, such as directly coupled to (e.g., via adhesives, interlocks, fasteners, welding, or the like), the first body portion 112a’. As depicted, the second body portion 112b’ extends distally from the first body portion 112a’ to provide an extending wall 120’. As above, the second portion 116b’ of the second fluid flow path 114b’ may be provided by a tubular cavity through the second body portion 112b’. Accordingly as in the embodiment above, the elongate tube 117’ may positioned within and extend through the second portion 116b’ of the second fluid flow path 114b’.

[0077] In the present embodiment, the second body portion 112b’ may not provide a mounting structure 140 as described above. Instead a mounting structure 140’ may include a locking member 142’. The locking member 142 may have an opening 143’ therethrough such that the second body portion 112b’ and elongate tube 117’ extends through the opening 143’. The opening 143’ may include a threaded portion 144’, which is internally threaded for engaging a mating threaded portion of a connector 300 or applicator 700 such as described above or further described below. Within the opening 143’, such as proximal to the threaded portion 144’ may be a shoulder 146’ which may jut into the opening 143’, thereby narrowing the opening 143’ at a position proximal to the threaded portion 144’. The second body portion 112b’ may include amating shoulder 113’. When assembled, the mating shoulder 113’ may engage the shoulder 146’ and prevent the locking member 142’ being pulled distally off of the second body portion 112b’. The locking member 142’ may be able to rotate relative to the fluid directing portion 112’. Accordingly, the locking member 142’ may be rotated to couple or uncouple the locking member 142 from the connector 300, applicator 700, and / or barrel cap 400 such as described above or further below. The mating shoulder 113’ may also press against the locking member 142’ to provide a stronger coupling force when fully engaged with a connected item.

[0078] FIGS. 6A and 6B illustrate a barrel cap 400’, similar to the barrel cap 400 described above, coupled to the barrel assembly 100’ with the mounting structure 140’. As in the embodiment above, the barrel cap 400’ may include a barrel cap connecting end 410’ which may be coupled to the mounting structure 140’. For example, the barrel cap connecting end 410’ may include a female luer connector which may threadingly engage with the locking member 142’ of the mounting structure 140’. As above, the barrel cap 400’ may include a tube receiving recess 420’, which may receive the elongate tube 117’ and may seal a distal end 113b’ of the elongate tube 117’. The sealing device 430’, such as an O-ring, which may seal against an outer surface of the elongate tube 117’ to further prevent fluid leakage around the outer surface of the elongate tube 117’. Additionally, the extending wall 120’ an inner surface of the barrel cap connecting end 410’, as depicted. When it is desired to mix constituent materials, the barrel cap 400’ may be removed from the barrel assembly 100.

[0079] Referring now to FIGS 7A-7C, another embodiment of a constituent material reservoir 200’ and connector 300’ are depicted. The constituent material reservoir 200’ and the connector 300’ are substantially similar to the constituent material reservoir 200 and the connector 300 described above. Accordingly, description of the constituent material reservoir 200 and the connector 300 applies equally to the present embodiment unless otherwise noted or apparent. Additionally, similar components are labeled similarly but include an following the reference numeral.

[0080] For example, the constituent material reservoir 200’ includes a first storage portion 210a’ and a second storage portion 210b’, which define an internal volume 211a’, 211b’ respectively. A plunger 202a’, 202b’ which may be received, respectively, within each internal volume 211a’, 211b’. That is, the reservoir body 205 may define two hollow voids providing separate internal volumes 211a’, 211b’. Referring to FIG. 7C, the first storage portion 210a’ and the second storage portion 210b are illustrated as including the first reservoir flow path 214a andthe second reservoir flow path 214b. However, in the present embodiment the above described directing portion 212 is incorporated in the connector 300’.

[0081] For example, the connector 300’ includes a connector housing 302 which may include a first housing portion 302a’, which substantially corresponds to the above-described directing portion 212, and a second housing portion 302b’, which includes a connecting end 320’. In embodiments, the first housing portion 302a’ is coupled to the reservoir body 205’ via any suitable coupling techniques (e.g., adhesives, press fit, fasteners, etc.). The connector 300’ defines a first connector flow path 314a’ and a second connector flow path 314b’. The first connector flow path 314a’ may have a first portion 315a’ which is fluidically coupled to the first reservoir flow path 214a’ and directs flow from the first reservoir flow path 214a’ to a centerline Cl’ of the constituent material reservoir 200’ . The first connector flow path 314a’ may have a second portion 315b’ which is fluidically coupled to the first portion 315a’ and direct fluid flow in a direction along and / or concentric with the centerline Cl’. The second connector flow path 314b’ may similarly have a first portion 316a’ which is fluidically coupled to the second reservoir flow path 214b’ and directs flow from the first reservoir flow path 214a’ toward the centerline Cl’ of the constituent material reservoir 200’. The second connector flow path 314b’ may similarly have a second portion 316b’ which is fluidically coupled to the first portion 315a’ and directs flow from the first reservoir flow path 214a’ distally in a direction parallel to but spaced from the centerline Cl’ of the constituent material reservoir 200’. In embodiments, a seal 330’ (e.g., an O-ring) may positioned within the first reservoir flow path 214a’ such as sandwiched between the first housing portion 302a’ and the second housing portion 302b’. The first housing portion 302a’ and the second housing portion 302b’ may be coupled together via any suitable coupling technique (e.g., welding, adhesive, fasteners, press-fit, etc.).

[0082] FIGS. 8A and 8B illustrated a reservoir cap 500’ coupled to the connector 300’ and constituent material reservoir 200’. As above, the reservoir cap 500’ couples to an end of the connector 300’ opposite the constituent material reservoir 200’. The reservoir cap 500’ may include a cap connector 510’ which may receive the connecting end 320’ of the connector 300 and be coupled thereto. For example, the cap connector 510’ may receive and threadingly couple to the connecting end 320’ of the connector 300’. The reservoir cap 500’ may have an extending portion 520’ that is received into the first connector flow path 314a’ and seals against the seal 330’ within the first connector flow path 314a’. The cap 500’ may include a cap extending wall 322’, which encircles to extending portion 520’. The cap extending wall 322’ may extend within and seal against an inner surface of the cap connector 510. Accordingly, by coupling to the connectingend 320’, the reservoir cap 500’ seals both the first connector flow path 314a’ and the second connector flow path 314b’.

[0083] FIGS. 9A and 9B illustrate an applicator 700’ similar to applicator 700 described above. Accordingly, description of the applicator 700’ applies equally to the present embodiment unless otherwise noted or apparent. Additionally, similar components are labeled similarly but include an following the reference numeral. For example, the applicator 700’ may include an applicator body 710’ which includes a mounting end 720’ for being coupled to the mounting structure 140’. For example, the mounting end 720’ may be received within and threadingly engage the mounting structure 140’ (though other coupling techniques are contemplated and possible). As above, the applicator 700’ may also define a first applicator flow path 714a’ and a second applicator flow path 714b’ . One or more portions of the first applicator flow path 714a and the second applicator flow path 714b’ may be, when mounted to the barrel assembly 100’, concentric with the centerline Cl’. In embodiments, the first applicator flow path 714a’ may include an applicator seal 730’ (e.g., an O-ring), which seals against an outer surface of the elongate tube 117 when assembled. Coupled to the applicator body 710’ may be an inner delivery tube 702a’ and an outer delivery tube 702b’, wherein the inner delivery tube 702a’ is positioned within the outer deliver tube 702b’.

[0084] FIGS. 10A-10J illustrate a method of using the mixing syringe system described herein. It is noted that though certain steps are shown, any number of steps are contemplated and possible. Further it is noted that while a particular embodiment is used for illustrative purposes, any of the embodiments herein would may be used or operated in a substantially similar manner.

[0085] In FIG. 10A and 10B, the barrel cap 400’ may be removed from the barrel assembly 100’ and the reservoir cap 500’ may be removed from the constituent material reservoir 200’ and connector 300’. In FIGS. 10C and 10D, the connector 300’ may be inserted over the elongate tube 117’ and received by the mounting structure 140’. In the present embodiment, the locking member 142’ may receive the connecting end 320’ via a threaded engagement. The locking member 142’ may be spun about the connecting end 320’ to secure the connecting end 320’ via the threaded engagement. As depicted, the elongate tube 117’ is received within the first connector flow path 314a’ and is engagement by the seal 330’. Similarly, the extending wall 120’ may engage an inner surface of the connecting end 320’ to form a seal therewith.

[0086] Once connected, constituent materials may be mixed. As illustrated in FIG. 10E, a first liquid constituent material 40a (also referred to as a first diluent) may be positioned withinthe first barrel 110a’ and a second liquid constituent material 40b (also referred to as a second diluent) may be positioned within the second barrel 110b’. As noted above, the liquid constituents 40a, 40b may be the same or different. The liquid constituents may include any diluents such as described above. A first powdered constituent material 42a (also referred to as a first powder) may be positioned within the first storage portion 210a’ and a second powdered constituent material 42b (also referred to as a second powder) may be positioned within the second storage portion 210b’ . The powdered constituent materials may include any of the materials described above and may be the same or different from one another. By depressing the plungers 102a’, 102b’, either simultaneously or separately, the liquid constituent material 40a, 40b may be advanced into the respective reservoir portions 210a’, 210b’. For example, the first liquid constituent material 40a may pass through the first fluid flow path 114a’ (including through the elongate tube 117’) and into the first connector flow path 314a’. The first connector flow path 314a’ may thereafter direct the first liquid constituent material 40a into the first reservoir flow path 214a’ and into the first storage portion 210a’. Similarly, the second liquid constituent material 40b may pass through the second fluid flow path 114b’. The first connector flow path 314b’ may thereafter direct the second constituent material 40b into the second reservoir flow path 214b’ and into the second storage portion 210b’. The fluid flow along the respective paths is illustrated by flow line 60a and flow line 60b. The assembly may then be agitated (e.g., shaken) to thoroughly mix the liquid constituents 40a, 40b with the respective powdered constituents 42a, 42b. In some embodiments, agitation may be provided by depressing and / or pulling the various plungers 102a’, 102b’, 202a’, 202b’ to produce turbulent flow for additional mixing. As illustrated in FIG. 10F, the resulting mixing provides a first mixture 44a in the first storage portion 210a’ and a second mixture 44b in the second storage portion 210b’. Once mixing is complete, the plungers 102a’, 102b’, 202a’, and / or 202b’ may be withdrawn or advanced to move the first mixture 44a and the second mixture 44b back along the flow lines 60a, 60b and back into the respective first barrel 110 and second barrel 110b’. For example, the first plunger 102a’, may be withdrawn to pull the first mixture 44a back into the first barrel 110a’. Similarly, the second plunger 102b’ may be withdrawn to pull the second mixture 44b back into the second barrel 110b’.

[0087] Referring now to FIG. 10G, the constituent material reservoir 200’ and the connector 300’ may be removed from the barrel assembly 100’ . For example, the locking member 142’ may be rotated to allow from uncoupling of the connector 300’ from barrel assembly 100’. The applicator 700’ may then be coupled to the barrel assembly 100’ . For example, the mounting end 720’ may be received within and threadingly engage the mount portion 140’, as depicted inFIG. 10H. For example, the locking member 142’ may be rotated to tightly onto the mounting end 720’. The elongate tube 117’ may be received within the first applicator flow path 714a’ and the applicator seal 730’ may seal against an outer surface of the elongate tube 117. In this manner, flow between the first applicator flow path 714a’ and the second applicator flow path 714b’ may be prevented. Additionally, the extending wall 120’ may engage an inner surface of the mounting end 720’ to form a seal therewith.

[0088] With reference to FIGS. 10H-10J, the distal ends of the inner delivery tube 702a’ and the outer delivery tube 702b’ may be positioned at a desired delivery site such as between diseased tissue and healthy tissue. The first mixture 44a and the second mixture 44b may then be delivered through respective fluid paths. For example, when the first plunger 102a’ is depressed, the first mixture 44a may pass through the first fluid flow path 114a’ of the barrel assembly 100’, distally through the elongate tube 117’. The elongate tube 117’ may thereafter direct the mixture into the first applicator flow path 714a’ so as to be passed through the inner delivery tube 702a’. This path is indicated by flow line 62a. Similarly, when the second plunger 102b’ is depressed, the second mixture 44b may pass through the second fluid flow path 114b’ of the barrel assembly 100’, along an outside surface of the elongate tube 117’ and into the second applicator flow path 714b’, wherein the second mixture 44b travels within the outer delivery tube 702b’ along an outer surface of the inner delivery tube 702a’ . Such flow is indicated by flow line 62b. In embodiments, the inner delivery tube 702a’ may end within a few millimeters (e.g., less than 5, such as 3 or less) from an end of the outer delivery tube 702b’. Such my assist in preventing clogs while delivery the first mixture 44a and the second mixture 44b. As depicted, the first mixture 44a and the second mixture 44b may gel on contact to provide substance 46, which may be a radiation spacer or other type implant.

[0089] In various embodiments, the components described herein may be provided as a kit. Constituent materials may be provided with the barrel assembly and constituent material reservoir in premeasured quantities. Accordingly, an easy to use system may be provided. Moreover, the embodiments with luer-type couplings as described herein may make it easy for practitioners to assemble and disassemble components. In some embodiments, other components may be easily combined. For example, a practitioner may couple a standard syringe to applicator 700 to hydrodissect with saline, for example, or inject other solutions through the dual lumen delivery tube structure. Embodiments described herein, provide for seamless interface to prevent leakage between components and easy, intuitive assembly / delivery.

[0090] Additional features may be described with respect to the following numbered clauses:

[0091] 1. A mixing syringe system for mixing constituent materials comprising: a barrel assembly comprising a first barrel and a second barrel and defining a first fluid flow path from the first barrel and a second fluid flow path from the second barrel, wherein at least a portion of the first fluid flow path is located within the second fluid flow path; a constituent material reservoir comprising a first storage portion and a second storage portion and defining a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path; and a connector housing configured to couple the barrel assembly to the constituent material reservoir, wherein the connector housing defines a first connector flow path and a second connector flow path, wherein the first connector flow path fluidically couples the first fluid flow path to the first reservoir flow path, and the second connector flow path fluidically couples the second fluid flow path to the second reservoir flow path.

[0092] 2. The mixing syringe system of clause 1, wherein the connector housing is threadingly coupled to the barrel assembly.

[0093] 3. The mixing syringe system of any preceding clause, wherein the connector housing comprises a first needle fluidically coupled to the first connector flow path and a second needle fluidically coupled to the second fluid flow path.

[0094] 4. The mixing syringe system of any preceding clause, wherein: the barrel assembly comprises an elongate tube forming part of the first fluid flow path; and the connector housing receives the elongate tube within the first connector flow path.

[0095] 5. The mixing syringe system of clause 4, wherein the elongate tube is position concentrically within the second fluid flow path.

[0096] 6. The mixing syringe system of clause 4 or 5, wherein at least a portion of the second connector flow path surrounds the elongate tube.

[0097] 7. The mixing syringe system of any preceding clause, wherein a portion of the first connector flow path is coaxial with a portion of the second connector flow path.

[0098] 8. The mixing syringe system of any preceding clause, further comprising a spacer configured to hold the barrel assembly in a spaced relationship relative to the constituent material reservoir.

[0099] 9. A mixing syringe system for mixing constituent materials comprising: a barrel assembly comprising a first barrel and a second barrel and defining a first fluid flow path from the first barrel and a second fluid flow path from the second barrel, wherein at least a portion of the first fluid flow path is located within the second fluid flow path; a constituent material reservoir comprising a first storage portion and a second storage portion and defining a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path; a connector housing configured to removably couple the barrel assembly to the constituent material reservoir, wherein the connector housing defines a first connector flow path and a second connector flow path, wherein the first connector flow path fluidically couples to the first fluid flow path to the first reservoir flow path, and the second connector flow path fluidically couples the second fluid flow path to the second reservoir flow path; and an applicator configured to be removably coupled to the barrel assembly.

[0100] 10. The mixing syringe system of clause 9, wherein the connector housing is threadingly coupled to the barrel assembly.

[0101] 11. The mixing syringe system of clause 9 or 10, wherein the connector housing comprises a first needle fluidically coupled to the first connector flow path and a second needle fluidically coupled to the second fluid flow path.

[0102] 12. The mixing syringe system of any of clauses 9-11, wherein: the barrel assembly comprises an elongate tube forming part of the first fluid flow path; and the connector housing receives the elongate tube within the first connector flow path.

[0103] 13. The mixing syringe system of clause 12, wherein the elongate tube is position concentrically within the second fluid flow path.

[0104] 14. The mixing syringe system of clause 13, wherein at least a portion of the second connector flow path surrounds the elongate tube.

[0105] 15. The mixing syringe system of any of clauses 9-14, wherein a portion of the first connector flow path is coaxial with a portion of the second connector flow path.

[0106] 16. The mixing syringe system of any of clauses 9-15, further comprising a spacer configured to hold the barrel assembly in a spaced relationship relative to the constituent material reservoir.

[0107] 17. A method of mixing constituent materials, the method comprising: coupling a barrel assembly to a constituent material reservoir, wherein: the barrel assembly comprises a firstbarrel and a second barrel and defines a first fluid flow path from the first barrel and a second fluid flow path from the second barrel, wherein at least a portion of the first fluid flow path is located within the second fluid flow path; the constituent material reservoir comprises a first storage portion and a second storage portion and defining a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path; and advancing a first plunger through the barrel assembly to advance a first diluent within the first barrel through the first fluid flow path and into the first storage portion to mix the first diluent with a first powder within the first storage portion.

[0108] 18. The method of cause 17, further comprising withdrawing the first plunger to pull a first mixture of the first diluent and the first powder into the first barrel.

[0109] 19. The method of clause 17 or 18, further comprising advancing a second plunger through the barrel assembly to advance a second diluent within the first barrel through the second fluid flow path and into the second storage portion to mixing the second diluent with a second powder within the second storage portion.

[0110] 20. The method of clause 19, further comprising withdrawing the second plunger to pull a second mixture of the second diluent and the second powder into the second barrel.[OHl] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

CLAIMS1. A mixing syringe system for mixing constituent materials comprising: a barrel assembly comprising a first barrel and a second barrel and defining a first fluid flow path from the first barrel and a second fluid flow path from the second barrel, wherein at least a portion of the first fluid flow path is located within the second fluid flow path; a constituent material reservoir comprising a first storage portion and a second storage portion and defining a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path; and a connector housing configured to couple the barrel assembly to the constituent material reservoir, wherein the connector housing defines a first connector flow path and a second connector flow path, wherein the first connector flow path fluidically couples the first fluid flow path to the first reservoir flow path, and the second connector flow path fluidically couples the second fluid flow path to the second reservoir flow path.

2. The mixing syringe system of claim 1, wherein the connector housing is threadingly coupled to the barrel assembly.

3. The mixing syringe system of claim 1, wherein the connector housing comprises a first needle fluidically coupled to the first connector flow path and a second needle fluidically coupled to the second fluid flow path.

4. The mixing syringe system of claim 1, wherein: the barrel assembly comprises an elongate tube forming part of the first fluid flow path; and the connector housing receives the elongate tube within the first connector flow path.

5. The mixing syringe system of claim 4, wherein the elongate tube is position concentrically within the second fluid flow path.

6. The mixing syringe system of claim 4, wherein at least a portion of the second connector flow path surrounds the elongate tube.

7. The mixing syringe system of claim 1, wherein a portion of the first connector flow path is coaxial with a portion of the second connector flow path.

8. The mixing syringe system of claim 1, further comprising a spacer configured to hold the barrel assembly in a spaced relationship relative to the constituent material reservoir.

9. A mixing syringe system for mixing constituent materials comprising: a barrel assembly comprising a first barrel and a second barrel and defining a first fluid flow path from the first barrel and a second fluid flow path from the second barrel, wherein at least a portion of the first fluid flow path is located within the second fluid flow path; a constituent material reservoir comprising a first storage portion and a second storage portion and defining a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path; a connector housing configured to removably couple the barrel assembly to the constituent material reservoir, wherein the connector housing defines a first connector flow path and a second connector flow path, wherein the first connector flow path fluidically couples to the first fluid flow path to the first reservoir flow path, and the second connector flow path fluidically couples the second fluid flow path to the second reservoir flow path; and an applicator configured to be removably coupled to the barrel assembly.

10. The mixing syringe system of claim 9, wherein the connector housing is threadingly coupled to the barrel assembly.

11. The mixing syringe system of claim 9, wherein the connector housing comprises a first needle fluidically coupled to the first connector flow path and a second needle fluidically coupled to the second fluid flow path.

12. The mixing syringe system of claim 9, wherein: the barrel assembly comprises an elongate tube forming part of the first fluid flow path; and the connector housing receives the elongate tube within the first connector flow path.

13. The mixing syringe system of claim 4, wherein the elongate tube is position concentrically within the second fluid flow path.

14. The mixing syringe system of claim 13, wherein at least a portion of the second connector flow path surrounds the elongate tube.

15. The mixing syringe system of claim 9, wherein a portion of the first connector flow path is coaxial with a portion of the second connector flow path.

16. The mixing syringe system of claim 9, further comprising a spacer configured to hold the barrel assembly in a spaced relationship relative to the constituent material reservoir.

17. A method of mixing constituent materials, the method comprising:coupling a barrel assembly to a constituent material reservoir, wherein: the barrel assembly comprises a first barrel and a second barrel and defines a first fluid flow path from the first barrel and a second fluid flow path from the second barrel, wherein at least a portion of the first fluid flow path is located within the second fluid flow path; the constituent material reservoir comprises a first storage portion and a second storage portion and defining a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path; and advancing a first plunger through the barrel assembly to advance a first diluent within the first barrel through the first fluid flow path and into the first storage portion to mix the first diluent with a first powder within the first storage portion.

18. The method of claim 17, further comprising withdrawing the first plunger to pull a first mixture of the first diluent and the first powder into the first barrel.

19. The method of claim 17, further comprising advancing a second plunger through the barrel assembly to advance a second diluent within the first barrel through the second fluid flow path and into the second storage portion to mixing the second diluent with a second powder within the second storage portion.

20. The method of claim 19, further comprising withdrawing the second plunger to pull a second mixture of the second diluent and the second powder into the second barrel.

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