Mixing syringe system and method for mixing constituent materials

Abstract

The mixing syringe system includes a barrel assembly, a component material reservoir, and a connector housing. The barrel assembly includes a first barrel and a second barrel, defining a first fluid channel and a second fluid channel, with a portion of the first fluid channel located within the second fluid channel. The component material reservoir defines a first reservoir channel and a second reservoir channel offset from the first reservoir channel. The connector housing connects the barrel assembly to the component material reservoir. The connector housing defines a first connector channel and a second connector channel. The first connector channel fluid-couples the first fluid channel to the first reservoir channel, and the second connector channel fluid-couples the second fluid channel to the second reservoir channel.

Description

Technical Field

[0001] Cross - reference to related applications

[0001] This application was filed on June 20, 2023, and claims priority to U.S. Provisional Patent Application No. 63 / 509,157, entitled "MIXING SYRINGE ASSEMBLIES AND METHODS OF MIXING CONSTITUENT MATERIALS", which is hereby incorporated by reference in its entirety.

[0002]

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

Background Art

[0003]

[0003] Prostate cancer is the most common cancer diagnosed in men other than skin cancer. Radiation therapy is an excellent treatment option for prostate cancer. However, radiation exposure can cause unintended side effects in adjacent non - target tissues. Radiation spacers, such as radiation protection spacers, can be implanted to avoid secondary radiation and minimize damage to nearby tissues by creating a space between the target tissue and non - target risk tissues.

[0004]

[0004] Conventional radiation spacers may contain a gelling material that is delivered as a liquid and allowed to harden. However, the components of the gel may start to gel when they come into contact with each other, which can make delivery difficult. Further, the components may need to remain separated until use, otherwise, the components may degrade over time due to limited stability.

Summary of the Invention

[0005]

[0005] Embodiments of the present disclosure relate to various mixing syringe systems that may maintain the separation of the constituent materials until time to use the mixed constituent materials. Embodiments also relate to methods of mixing constituent materials using the mixing syringe assemblies described herein.

[0006]

[0006] In one embodiment, the mixing syringe system for mixing constituent materials may include a barrel assembly, a constituent material reservoir, and a connector housing. The barrel assembly includes a first barrel and a second barrel, defining a first fluid passage from the first barrel and a second fluid passage from the second barrel, with at least a portion of the first fluid passage positioned within the second fluid passage. The constituent material reservoir includes a first storage section and a second storage section, defining a first reservoir passage and a second reservoir passage offset from the first reservoir passage. The connector housing is configured to connect the barrel assembly to the constituent material reservoir. The connector housing defines a first connector passage and a second connector passage. The first connector passage fluidly couples the first fluid passage to the first reservoir passage, and the second connector passage fluidly couples the second fluid passage to the second reservoir passage.

[0007]

[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 detachably coupled to the barrel assembly. The barrel assembly includes a first barrel and a second barrel, defining a first fluid flow path from the first barrel and a second fluid flow path from the second barrel, with at least a portion of the first fluid flow path located within the second fluid flow path. The constituent material reservoir includes a first storage section and a second storage section, defining 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 channel fluid-couples the first fluid channel to the first reservoir channel, and the second connector channel fluid-couples the second fluid channel to the second reservoir channel.

[0008]

[0008] In yet another embodiment, the method for mixing the constituent materials includes coupling a barrel assembly to a constituent material reservoir. The barrel assembly includes a first barrel and a second barrel, defining a first fluid channel from the first barrel and a second fluid channel from the second barrel, with at least a portion of the first fluid channel positioned within the second fluid channel. The constituent material reservoir includes a first storage section and a second storage section, defining a first reservoir channel and a second reservoir channel offset from the first reservoir channel. The method further includes advancing a first plunger through the barrel assembly, thereby advancing a first diluent in the first barrel through the first fluid channel into the first storage section, to mix the first diluent with the first powder in the first storage section.

[0009]

[0009] Further features and advantages of the embodiments described herein will be stated in the following detailed description, and some will be readily apparent to those skilled in the art from that description, or will be recognized by carrying out the embodiments described herein, including the following detailed description, claims, and accompanying drawings.

[0010]

[0010] It is understood that the above general description and the following detailed description together are intended to describe various aspects and to provide an overview or framework for understanding the nature and characteristics of the claimed subject matter. The accompanying drawings are included to provide a further understanding of the various aspects and are incorporated herein and constitute part of this specification. The drawings illustrate the various aspects described herein and, together with the description, are useful in illustrating the principles and operations of the claimed subject matter.

[0011]

[0011] Embodiments described in the drawings are illustrative and exemplary in nature and are not intended to limit the subject matter defined by the claims. The following detailed description of illustrative embodiments should be understood in conjunction with the following drawings, in which similar structures are indicated by similar reference figures. [Brief explanation of the drawing]

[0012] [Figure 1A]

[0012] This is a schematic diagram showing a syringe assembly according to one or more embodiments shown and described herein. [Figure 1B]

[0013] This figure schematically shows a spacer removed from the syringe assembly of Figure 1A according to one or more embodiments shown and described herein. [Figure 1C]

[0014] Figure 1B is a schematic cross-sectional view of a syringe assembly according to one or more embodiments shown and described herein. [Figure 1D]

[0015] This is a schematic cross-sectional view of the syringe assembly of Figure 1C, with the engagement configuration moved according to one or more embodiments shown and described herein. [Figure 2]

[0016] This figure schematically shows a barrel cap coupled to the barrel assembly shown in Figures 1A to 1D, according to one or more embodiments shown and described herein. [Figure 3]

[0017] This figure schematically shows a reservoir cap coupled to a constituent material reservoir according to one or more embodiments shown and described herein. [Figure 4A]

[0018] Figures 1A to 1D schematically show applicators coupled to barrel assemblies, in order to provide applicator assemblies according to one or more embodiments shown and described herein. [Figure 4B]

[0019] This is a schematic cross-sectional view of the applicator assembly shown in Figure 4A, according to one or more embodiments shown and described herein. [Figure 5A]

[0020] This is a substantially perspective view of a barrel assembly according to one or more embodiments shown and described herein. [Figure 5B]

[0021] This is a schematic front view of the barrel assembly shown in Figure 5A, according to one or more embodiments shown and described herein. [Figure 5C]

[0022] This is a schematic cross-sectional view of the barrel assembly shown in Figure 5A, according to one or more embodiments shown and described herein. [Figure 6]

[0023] Figure 6A is a schematic diagram showing a barrel cap connected to the distal end of the barrel assembly shown in Figures 5A-5C, according to one or more embodiments shown and described herein.

[0024] Figure 6B is a substantially cross-sectional view of the distal end of the barrel cap and barrel assembly of Figure 6A, according to one or more embodiments shown and described herein. [Figure 7A]

[0025] This is a substantially perspective view of a constituent material reservoir according to one or more embodiments shown and described herein. [Figure 7B]

[0026] A schematic front view of the constituent material reservoir of FIG. 7A according to one or more embodiments shown and described herein. [Figure 7C]

[0027] A schematic cross-sectional view of the proximal end of the constituent material reservoir of FIG. 7A according to one or more embodiments shown and described herein. [Figure 8]

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

[0029] FIG. 8B is a schematic cross-sectional view of the reservoir cap of FIG. 8A and the distal end of the constituent material reservoir according to one or more embodiments shown and described herein. [Figure 9]

[0030] FIG. 9A is a schematic perspective view of an applicator according to one or more embodiments shown and described herein.

[0031] FIG. 9B is a schematic cross-sectional view of the applicator of FIG. 9A according to one or more embodiments shown and described herein. [Figure 10A]

[0032] A diagram schematically showing a barrel assembly having the barrel caps of FIGS. 6A and 6B aligned with the constituent material reservoir and the reservoir cap of FIGS. 8A and 8B according to one or more embodiments shown and described herein. [Figure 10B]

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

[0034] A diagram schematically showing a barrel assembly and a constituent material reservoir of FIG. 10B connected to each other to provide a mixing syringe assembly according to one or more embodiments shown and described herein. [Figure 10D]

[0035] Figure 10C is a schematic cross-sectional view of a mixing syringe assembly according to one or more embodiments shown and described herein. [Figure 10E]

[0036] This figure schematically shows the flow path through the mixing syringe assembly of Figure 10D in a first direction, according to one or more embodiments shown and described herein. [Figure 10F]

[0037] This figure schematically shows the flow path through the mixing syringe assembly in the second opposite direction to that shown in Figure 10D, according to one or more embodiments shown and described herein. [Figure 10G]

[0038] This is a schematic cross-sectional view of the barrel assembly of Figure 5A aligned with the applicator of Figure 9A, according to one or more embodiments shown and described herein. [Figure 10H]

[0039] Figure 10G shows a schematic cross-sectional view of the applicator coupled to a barrel assembly, to provide an applicator assembly according to one or more embodiments shown and described herein. [Figure 10I]

[0040] This is another schematic cross-sectional view of the applicator of Figure 10H according to one or more embodiments shown and described herein. [Figure 10J]

[0041] This figure schematically illustrates the delivery of a radiation spacer having the applicator shown in Figure 10I according to one or more embodiments shown and described herein. [Modes for carrying out the invention]

[0013]

[0042] This disclosure generally pertains to mixing syringe assemblies for mixing and / or dispensing at least two constituent materials. More specifically, this application pertains to mixing syringe assemblies configured for dispensing radiation spacers. For example, a radiation spacer may be formed of one or more hydrogel materials, which are dispensed to a desired location, such as within a balloon or on themselves, and cured in place to block or substantially block radiation that may be unintentionally directed to healthy tissue instead of target / disease tissue. During the mixing of hydrogels to form a radiation spacer, the multiple materials may need to be bound immediately before and / or at the time of dispensing the radiation spacer into the target location in the body. To maintain the quality of the materials, powder components may need to be kept dry or uncomposed before application. However, during use, powder components may need to be hydrated or mixed with a diluent. Determining the appropriate mixing volume, maintaining sterility, and preventing unnecessary premature mixing can be difficult using traditional methods. Embodiments of the present disclosure may provide constituent materials in a pre-packaged, pre-measured, and ready-to-use syringe assembly that maintains sterility and / or improves mixing and / or dispensing, as described in more detail herein.

[0014]

[0043] In certain embodiments, the liquid component may be contained within the barrel assembly, while the powder component may be contained within the component reservoir. If mixing is desired, the barrel assembly and the component reservoir may be joined together. A connector housing may connect the barrel assembly and the component reservoir. In some embodiments, the barrel assembly may include a first barrel and a second barrel, defining a first fluid passage from the first barrel and a second fluid passage from the second barrel. In some embodiments, at least a portion of the first fluid passage is located within the second fluid passage. Such arrangements may allow for lower profile delivery and more compact components. Furthermore, as will be discussed further below, in certain embodiments, a Luer-type connector is used to enable seamless transitions between standard components and various components of the assemblies described herein.

[0015]

[0044] The directional terms used herein—for example, up, down, right, left, front, back, top, and bottom—are made solely by reference to the depicted figures and are not intended to suggest absolute orientation unless otherwise specified. The directional term "proximal" generally refers to a direction away from the origin, such as towards the handle. The directional term "distal" generally refers to a direction away from the origin, such as towards the tip of the device.

[0016]

[0045] Unless otherwise expressly stated, it is never intended that any method described herein requires its steps to be performed in a specific order, nor that any device requires a specific orientation. Therefore, if a claim for a method does not actually describe the order followed by its steps, or if a claim for any device or assembly does not actually describe the order or orientation to its individual components, or if the steps are limited to a specific order, or if a specific order or orientation to the components of a device or assembly is not described, unless otherwise specifically stated in the claim or description, it is never intended that any order or orientation be presumed in any respect. This applies to any possible non-express basis for interpretation, including logical matters concerning the arrangement of steps, the flow of operations, the order of components, or the orientation of components; plain meaning derived from grammatical organization or punctuation; and the number or type of embodiments described herein.

[0017]

[0046] As used herein, the singular forms “a,” “an,” and “the” include multiple referents unless the context explicitly indicates otherwise. For example, a reference to a “a” component includes embodiments having two or more such components unless the context explicitly indicates otherwise. As used herein, the term “and / or” refers to the inclusion of one or more referents. For example, A and / or B would include embodiments containing only A, only B, or both A and B.

[0018]

[0047] Referring here to the drawings, Figure 1A shows one or more components of the mixing syringe system 10. The mixing syringe system 10 may be used to combine two or more constituent materials, as will be described in more 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 should be noted that the mixing syringe system 10 may include more or fewer components without departing from the scope of this disclosure. For example, and as will be described in more detail below, the mixing syringe system 10 may also include an applicator 700 (for example, shown in Figures 4A and 4B). The various components provided herein may be made of any suitable material such as glass, plastic, metal, etc.

[0019]

[0048] The barrel assembly 100 includes a first barrel 110a and a second barrel 110b; however, it is intended that the barrel assembly 100 may include any number of barrels, such as one or more, two or more, etc. In some embodiments, the barrel assembly 100 includes a barrel body 105 defining the first barrel 110a and the second barrel 110b. That is, the first barrel 110a and the second barrel 110b may be integral with each other. In other embodiments, the first barrel 110a and the second barrel 110b may be joined to each other by welding, adhesive, fasteners, brackets, etc. Each of the first barrel 110a and the second barrel 110b defines internal volumes 111a, 111b which may receive plungers 102a, 102b. That is, the barrel body 105 may define two hollow voids providing separate internal volumes 111a, 111b, similarly shown in Figures 1C and 1D.

[0020]

[0049] Referring again to Figure 1A, the barrel assembly 100 may have a proximal end 113a that provides openings into each of the respective internal volumes 111a, 111b to receive the plungers 102a, 102b. At the distal end 113b opposite the proximal end 113a, the barrel body 105 may include a fluid directioning section 112 that provides a flow path to and from the respective internal volumes 111a, 111b. Such a fluid flow path will be described in more detail below. The fluid directioning section 112 may be integral with the first barrel 110a and the second barrel 110b or coupled to them (by any joining technique such as welding, fasteners, interlocks, etc.).

[0021]

[0050] Referring again to Figure 1A, the plungers 102a and 102b may be slidably disposed within the first barrel 110a and the second barrel 110b of the barrel body 105, respectively, and a fluid seal with the barrel body 105 may be formed by a seal at the distal end of each plunger 102a and 102b. For example, the seal may be made of rubber or a similar conformable material to form a fluid sealing seal with the first barrel 110 or the second barrel 110b. The plungers 102a and 102b may act independently, or they may be tightly coupled to each other so that they act simultaneously when either is pushed in / pulled in along the longitudinal axis.

[0022]

[0051] In several embodiments, the first barrel 110a and the second barrel 110b may originally hold a liquid component for dissolving or suspending powders / particles as described in more detail below. The liquid component may include saline solution, water, deionized water, or similar. In some embodiments, the liquid component may be liquid albumin. Accordingly, the first barrel 110 may hold a first diluent, and the second barrel 110b may hold a second diluent. The first and second diluents may be the same or different, and / or have the same or different volumes.

[0023]

[0052] The constituent material reservoir 200 includes a first storage portion 210a and a second storage portion 210b; however, the constituent material reservoir 200 may include any number of storage portions, such as one or more, two or more, etc. In several embodiments, the constituent material reservoir 200 includes a reservoir body 205 defining the 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 each other. In other embodiments, the first storage portion 210a and the second storage portion 210b may be joined to each other by welding, adhesive, fasteners, brackets, etc. Each of the first storage portion 210a and the second storage portion 210b defines internal volumes 211a, 211b which may receive plungers 202a, 202b. In other words, the reservoir body 205 may define two hollow voids providing separate internal volumes 211a, 211b as shown in Figures 1C and 1D.

[0024]

[0053] Referring again to Figure 1A, the constituent material reservoir 200 may have a proximal end 213a that provides an opening into the respective internal volumes 211a, 211b to receive the plungers 202a, 202b. At the distal end 213b opposite the proximal end 213a, the reservoir body 205 may include a directional portion 212 that provides a flow path to and from the respective internal volumes 211a, 211b. Such a fluid flow path will be described in more detail below. The directional portion 212 may be integral with the first storage portion 210a and the second storage portion 210b or coupled to them (by any joining technique such as welding, fasteners, interlocks, etc.).

[0025]

[0054] Referring again to Figure 1, the plungers 202a and 202b may be slidably disposed within the first storage portion 210a and the second storage portion 210b of the reservoir body 205, respectively, and a fluid seal with the reservoir body 205 may be formed by a seal at the distal end of each plunger 202a and 202b. For example, the seal may be made of rubber or a similar conformable material to form a fluid sealing seal with the first barrel 110 or the second barrel 110b. The plungers 202a and 202b may act independently, or they may be tightly coupled to each other so that they act simultaneously when either is pushed in / pulled in along the longitudinal axis. In some embodiments, the constituent material reservoir 200 may not include the plungers 202a and 202b. However, the inclusion of plunger 102a may assist in mixing and moving the material between the constituent material reservoir 200 and the barrel assembly 100.

[0026]

[0055] In several embodiments, the first storage section 210a and the second storage section 210b may initially hold / store the powder components described above. The powder components may be fine particles such as powders or particulate materials, including, but not limited to, albumin, polyethyleneimine (PEI), amine-containing polyethylene glycol (PEG) or proteins, and N-hydroxysuccinimide (NHS) ester components such as PEG-(SS)2, PEG-(SS)4, PEG-(SS)8, PEG-(SG)4, PEG-(SG)8, and / or similar. In some embodiments, the molecular weight of the PEG component may range from about 2,000 to about 100,000. For example, the first storage section 210a may hold sodium carbonate or other pH adjusters, and the second storage section 210b may hold 20,000 MW of PEG-(SS)8. The powder or particulate materials may be biodegradable and / or bioabsorbable. As used herein, “biodegradable” and / or “bioabsorbable” refer to compounds that can be absorbed by the surrounding or local tissues of a subject and / or that can be broken down and absorbed by the subject's tissues.

[0027]

[0056] The powder or particulate material may consist of various amounts of different cross-linking substances designed to allow the hydrogel to persist in situ for a specific period before degrading. In several embodiments, the hydrogel components may be selected based on the degradation time corresponding to the expected length of radiotherapy. In several embodiments, the expected length of radiotherapy, and therefore the target time for hydrogel degradation, is up to 18 months, for example, in the range of about 0 to about 18 months, and includes about 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, and 18 months. It should be understood that the time is only a rough guideline commonly used to target the appropriate formulation of the hydrogel.

[0028]

[0057] As will be described in more detail herein, the connector 300 is configured to connect the barrel assembly 100 to the constituent material reservoir 200. As will be described with reference to further figures, the connector 300 may include a connector housing 302 that defines separate connector 300 channels for fluid coupling the first barrel 110 to the first storage portion 210a and the second barrel 110b to the second storage portion 210b. In some embodiments, the connector housing 302 may be detachably coupled to the barrel assembly 100 and / or the constituent material reservoir 200.

[0029]

[0058] In some embodiments, and as shown in Figure 1A, the barrel assembly 100 and the constituent material reservoir 200 are initially assembled with the connector 300, but do not yet fluid-coupled. For example, the connector 300 may include a spacer 325, which is positioned between the connector housing 302 and the proximal end 213a of the constituent material reservoir 200 to maintain a degree of separation (i.e., a separated relationship) between the constituent material reservoir 200 and the connector housing 302 until fluid communication and engagement are desired. In some embodiments, the spacer 325 may be absent, and instead, the components may simply be maintained in a disassembled state until mixing is desired. For example, Figure 1B shows the spacer 325 removed from the mixing syringe system 10. In some embodiments, and as will be described in more detail herein, caps may be used to close the respective distal ends 113b, 213a of the barrel assembly 100 and the constituent material reservoir 200 until use. Such measures may help prevent the decomposition of the constituent materials within the constituent material reservoir 200 and / or barrel assembly 100.

[0030]

[0059] Figures 1C and 1D show longitudinal cross-sections of the mixing syringe system 10 of Figure 2A in the engagement / disengagement configuration (Figure 1C) and the engagement configuration (Figure 1D), respectively.

[0060] As described above, the fluid directionor portion 112 provides fluid channels to and from the internal volumes 111a and 111b of the first barrel 110a and the second barrel 110b, respectively. The fluid directionor portion 112 may define a first fluid channel 114a from the first barrel 110a and a second fluid channel 114b from the second barrel 110b. At least a portion 520' of the first fluid channel 114a is located within the second fluid channel 114b. For example, each of the first fluid channel 114a and the second fluid channel 114b may direct the fluid toward the centerline C1 of the barrel assembly 100. Around the centerline C1 of the barrel assembly 100, the first fluid channel 114a may be located within the second fluid channel 114b while remaining isolated from the second fluid channel 114b (e.g., the fluids do not mix). In other words, at least a portion of the first fluid channel 114a is located within the second fluid channel 114b.

[0031]

[0061] In this particular embodiment, the first portion 115a of the first fluid channel 114a may be formed within or at least partially by the first body portion 112a of the fluid directionor portion 112. The second portion 115b of the first fluid channel 114a may be provided by an elongated tube 117 (e.g., a tube, cannula, or similar). That is, the elongated tube 117 may form part of the first fluid channel 114a. The elongated tube 117 may be coupled to the first body portion 112a, such as within the first portion 115a of the first fluid channel 114a, and the second portion 115b of the first fluid channel 114a may be provided through the elongated tube 117. In some embodiments, the elongated tube 117 may be press-fitted, bonded, or similar to the first body portion 112a. The elongated tube 117 may be made of any suitable material, such as metal, plastic, or similar, to maintain fluid stream separation.

[0032]

[0062] The first portion 116a of the second fluid channel 114b may also be formed within the first body portion 112a of the fluid directionor portion 112. The second portion 116b of the second fluid channel 114b may be formed within the second body portion 112b of the fluid directionor portion 112, which is coupled to the first body portion 112a, for example, by direct coupling (e.g., by adhesive, interlock, fastener, welding, or similar). The second portion 116b of the second fluid channel 114b may be provided by a tubular cavity passing through the second portion 116b. In such embodiments, an elongated tube 117 may be positioned within and extending through the second portion 116b of the second fluid channel 114b. For example, the elongated tube 117 may be concentrically positioned within the second portion 116b of the second fluid channel 114b. Accordingly, the fluid may flow through the second portion 116b of the second fluid channel 114b and around the outer surface of the elongated tube 117. In some embodiments, the elongated tube 117 may extend distally beyond the end of the second body portion 112.

[0033]

[0063] In several embodiments, the fluid directionation portion 112, such as the second body portion 112, may include a mounting structure 140 for receiving and coupling various components of the mixing syringe system 10. For example, as shown, the mounting structure 140 may be a Luer or screw connector for receiving and coupling a connector 300. For example, the connector housing 302 may include a connecting end 320 that is received within the mounting structure 140 and configured to engage therewith in a screw-like manner. In several embodiments, and to prevent fluid leakage, the fluid directionation portion 112, such as the second body portion 112, may include an extension wall 120 that extends concentrically within the mounting structure 140, separating the mounting structure 140 from the second fluid passage 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 extension wall 120 and the mounting structure 140. For example, the mounting structure 140 and extension wall 120 may receive a Luer-type fitting, for example, a female Luer fitting provided by the connecting end 320 of the connector 300, and provide a male portion of the Luer fitting that connects like a screw. The extension wall 120 may engage with the inner surface of the mounting end 320 to provide a fluid seal with the mounting end 320. Other connection structures are conceivable and possible. For example, press-fit or a combination of pins or other types of fasteners are conceivable and possible.

[0034]

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

[0035]

[0065] Referring again to Figures 1C and 1D, the constituent material reservoir 200, such as the reservoir body 205, may also include a directional portion 212 that provides a flow path to and from the respective internal volumes 211a and 211b. The directional portion 212 may define a first reservoir flow path 214a from the first storage portion 210a and a 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 as shown, so that the first reservoir flow path 214a and the second reservoir flow path 214b do not share common space. Accordingly, and as shown, the first reservoir channel 214a and the second reservoir channel 214b may both direct the fluid toward the indicated centerline C1, but only one (e.g., the first reservoir channel 214a) is shown as being concentric with and extending along the centerline C1. In some embodiments, and as shown, seals 215a, 215b (e.g., rubber, foil, or other seals) may be positioned at the distal ends 113b of the first reservoir channel 214a and the second reservoir channel 214b to help maintain the sterility and freshness of the pulverized constituent materials in the respective first storage section 210a and second storage section 210b.

[0036]

[0066] As described above, the connector 300 may include a connector housing 302 that defines separate connector 300 channels for fluid coupling the first barrel 110a to the first storage section 210a and the second barrel 110b to the second storage section 210b. As shown in Figures 1C and 1D, for example, the connector housing 302 may define a first connector channel 314a and a second connector channel 314b. The first connector channel 314a may be fluid coupled to the first fluid channel 114a, and the second connector channel 314b may be fluid coupled to the second fluid channel 114b. For example, when assembled into a barrel assembly, the elongated tube 117 may be received into the first connector channel 314a. As shown, at least a portion of the second connector channel 314b may surround the elongated tube 117 and receive the flow from the second fluid channel 114b. In several embodiments, the connector 300 may include a seal 330 (such as an O-ring) that seals against the outer surface of the elongated tube 117 to prevent fluid leakage between the first connector channel 314a and the second connector channel 314b. Accordingly, and as shown, portions of the first connector channel 314a and the second connector channel 314b may extend concentrically around the centerline C1. That is, portions of the first connector channel 314a and the second connector channel 314b may be coaxial with each other. However, in the shown embodiments, the flow along the centerline C1 of the second connector channel 314b may deviate from extending along the centerline C1 and be radially offset from the centerline C1 or otherwise offset from each other. In several embodiments, the first connector channel 314a may be concentric with the centerline C1 along its entire length.

[0037]

[0067] In several embodiments, a first needle 316a and a second needle 316b may be present at the distal ends 113b of the first connector channel 314a and the second connector channel 314b, respectively. The first and second needles 216a and 216b may extend to pointed ends which may be configured to perforate the first seal 215a and the second seal 215b, respectively. The first needle 216a and the second needle 216b may be press-fitted to or otherwise fixed to the connector housing 302 and extend into the first connector channel 314a and the second connector channel 314b. The first needle 316a and the second needle 316b may be made of any suitable material such as plastic, metal, or the like.

[0038]

[0068] As shown in Figure 1D, when moved to an engagement configuration with the constituent material reservoir 200, the first connector channel 314a fluid-couples the first fluid channel 114a to the first reservoir channel 214a, and the second connector channel 314b fluid-couples the fluid channel to the second reservoir channel 214b. For example, the first needle 216a may perforate the first seal 215a, and the second needle 216b may perforate the second seal 215b, thereby providing continuous channels between the first barrel 110 and the first storage portion 210a, and between the second barrel 110b and the second storage portion 210b.

[0039]

[0069] Referring briefly to Figure 3, in some embodiments, the connector 300 may be coupled to the constituent material reservoir 200. For example, the connector housing 302 may be firmly coupled to the connector 300 by adhesive, welding, fasteners, or the like. In such embodiments, the connector 300 may or may not include a first needle 216a and a second needle 216b. Similarly, the connector 300 and the constituent material reservoir 200 may or may not include a first seal 215a and a second seal 215b. In some embodiments, the connector 300 may be coupled to the constituent material reservoir 200 by a sliding arrangement configuration or similar structure to allow movement of components relative to each other. As shown, a reservoir cap 500 may be included to seal unwanted or inadvertent material flow from the constituent material reservoir 200. In the shown embodiment, the reservoir cap 500 is coupled to the end of the connector 300 facing the constituent material reservoir 200. The reservoir cap 500 may include a cap connector 510, which may receive and connect to the connecting end 320 of the connector 300. For example, the cap connector 510 may receive the connecting end 320 of the connector 300 and connect to it in a screw-like manner. The reservoir cap 500 may have an extension 520, which is received into the first connector channel 314a and seals against the seal 330 in the first connector channel 314a. By connecting to the connecting end 320, the reservoir cap 500 seals both the first connector channel 314a and the second connector channel 314b.

[0040]

[0070] Referring again to Figure 1D, once fluid-coupled, the first constituent material in each of the first and second barrels 110a, 110b may be advanced along the first and second fluid channels 114a, 114b, into the first and second connector channels 314a, 314b, and then through the first and second reservoir channels 214a, 214b (e.g., by the plungers 102a, 102b of the barrel assembly 100) to mix with the second (e.g., powdered) constituent material in the first and second storage sections 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, any of the plungers 102a, 102b, 202a, 202b may be pushed or pulled to further assist the mixing. After mixing, the resulting solutions in the first storage portion 210a and the second storage portion 210b within the constituent material reservoir 200 may be returned to the syringe assembly 210 (or, in some embodiments, retained within the constituent material reservoir 200).

[0041]

[0071] As described above, the components to be joined here may be retracted into or forcibly returned to the barrel assembly 100 (for example, by the operation of plungers 102a, 102b, 202a, 202b). In this state, the connector 300 may be detached from the barrel assembly 100, for example, along the component reservoir 200. Referring here to Figures 4A and 4B, the applicator 700 may be coupled to the barrel assembly 100, for example, detachably, to provide the applicator assembly 20. For example, the applicator 700 may be attached to the mounting structure 140 described above. In other embodiments, it is intended that the applicator 700 may instead be attached to the component reservoir 200.

[0042]

[0072] Referring again to Figures 4A and 4B, the applicator 700 may include an applicator body 710, the applicator body 710 including a mounting end 720 for coupling to a mounting structure 140. For example, the mounting end 720 may be received within the mounting structure 140 and engage therewith (although other coupling techniques are intended and possible). In such embodiments, the extension portion 120 may engage with the inner surface of the mounting end 720 and seal thereto. In several embodiments, the mixtures in the first barrel 110 and the second barrel 110b may need to maintain separation until delivery at a desired location within the body. For example, the materials may gel upon contact, which may make delivery difficult if separation is not maintained. Accordingly, the applicator 700 may also define a first applicator channel 714a and a second applicator channel 714b. The first fluid channel 114a may be fluid-coupled to the first applicator channel 714a, and the second fluid channel 114b may be fluid-coupled to the second applicator channel 714b. One or more portions of the first applicator channel 714a and the second applicator channel 714b may be concentric with the center line C1 when attached to the barrel assembly 100. In some embodiments, the first applicator channel 714a may include an applicator seal 730 (e.g., an O-ring) that seals against the outer surface of the elongated tube 117. The second fluid channel 714b may direct the fluid along the outer surface of the elongated tube 117. The applicator body 710 may be connected to an inner discharge tube 702a and an outer discharge tube 702b, the inner discharge tube 702a being concentrically positioned within the outer discharge tube 702b, for example. The inner discharge tube 702a is fluid-coupled to the first applicator flow path 714a, and the outer discharge tube 702b is fluid-coupled to the second applicator flow path 714b. Accordingly, as the plungers 102a and 102b advance, the mixed material in the first barrel 110 advances through the first fluid flow path 114a, the first applicator flow path 714a, and the inner discharge tube 702a.Similarly, the mixed material in the second barrel 110b is advanced through the second fluid channel 114b, the second applicator channel 714b, and the outer discharge tube 702b.

[0043]

[0073] Referring here to Figures 5A-5C, another embodiment of the barrel assembly 100' is shown in its entirety. The barrel assembly 100' is substantially similar to the barrel assembly 100 described above. Accordingly, the description of the barrel assembly 100 applies similarly to this embodiment unless otherwise stated or evident. Furthermore, similar components are similarly labeled, but include a "'" following the reference number. Accordingly, the barrel assembly 100' may include a first barrel 110a' and a second barrel 110b' defining separate internal volumes 111a', 111b'. The plungers 102a', 102b' may be positioned within the internal volumes 111a', 111b' to push in / out of / from the internal volumes 111a', 111b'. At the distal end 113b' opposite the proximal end 113a' of the barrel body 105', a fluid directionor portion 112' may be present, and the fluid directionor portion 112' provides a flow path to and from the respective internal volumes 111a' and 111b'.

[0044]

[0074] Referring particularly to Figure 5C, the fluid directionor portion 112' differs somewhat from the fluid directionor portion 112 described above. The fluid directionor portion 112' defines a first fluid channel 114a' from the first barrel 110a' and a second fluid channel 114b' from the second barrel 110b'. At least a portion 520' of the first fluid channel 114a' is located within the second fluid channel 114b'. For example, each of the first fluid channel 114a' and the second fluid channel 114b' may direct the fluid toward the centerline C1' of the barrel assembly 100. Around the centerline C1' of the barrel assembly 100', the first fluid channel 114a' may be located within the second fluid channel 114b' while remaining isolated from the second fluid channel 114b' (e.g., the fluids do not mix).

[0045]

[0075] In this particular embodiment, the first portion 115a' of the first fluid passage 114a' may be formed within or at least partially by the first body portion 112a' of the first directional portion 112, and the first portion 115b' of the first fluid passage 114a may be provided by an elongated tube 117' (e.g., a tube, cannula, or the like). The elongated tube 117' may be coupled to the first body portion 112a', for example, within the first portion 115a' of the first fluid passage 114a', and the first portion 115b' of the first fluid passage 114a may be provided through the elongated tube 117'. As in the above embodiment, the elongated tube 117' may be press-fitted, bonded, or similar to the first body portion 112a'.

[0046]

[0076] The first portion 116a' of the second fluid channel 114b' may also be formed within the first body portion 112a' of the fluid directional portion 112. The second portion 116b of the second fluid channel 114b may also be formed within the second body portion 112b' of the fluid directional portion 112. In the shown embodiment, the second body portion 112b' is formed integrally with the first body portion 112a', but instead may be bonded to the first body portion 112a', for example, directly bonded to it (e.g., by adhesive, interlock, fastener, or similar). As shown, the second body portion 112b' extends distally from the first body portion 112a' to form an extension wall 120'. As described above, the second portion 116b' of the second fluid channel 114b' may be provided by a tubular cavity passing through the second body portion 112b'. Accordingly, as in the above embodiment, the elongated tube 117' may be positioned within and extending through the second portion 116b' of the second fluid passage 114b'.

[0047]

[0077] In this embodiment, the second body portion 112b' does not have to provide the mounting structure 140 described above. Instead, the mounting structure 140' may include a locking member 142'. The locking member 142 may have an opening 143' through which the second body portion 112b' and the elongated tube 117' extend through the opening 143'. The opening 143' may include a threaded portion 144', which is internally threaded to engage with a mating threaded portion of the connector 300 or applicator 700, as described above or further below. A shoulder portion 146' may be present within the opening 143', such as proximal to the threaded portion 144', and the shoulder portion 144' may protrude into the opening 143', thereby narrowing the opening 143' at the proximal position of the threaded portion 144'. The second body portion 112b' may include a mating shoulder portion 113'. When assembled, the mating shoulder portion 113' may engage with the shoulder portion 146' to prevent the locking member 142' from being pulled distally from the second body portion 112b'. The locking member 142' may be rotatable relative to the fluid direction portion 112'. Accordingly, the locking member 142' may rotate to engage with or disengage the locking member 142 from the connector 300, applicator 700, and / or barrel cap 400, as described above or further below. The mating shoulder portion 113' may also press against the locking member 142' to provide a stronger binding force when fully engaged with the item being coupled.

[0048]

[0078] Figures 6A and 6B show a barrel cap 400' similar to the barrel cap 400 described above, coupled to a barrel assembly 100' having a mounting structure 140'. As in the above embodiments, the barrel cap 400' may include a barrel cap connection end 410' which may be coupled to the mounting structure 140'. For example, the barrel cap connection end 410' may include a female Luer connector which may engage in a screw-like manner with a locking member 142' of the mounting structure 140'. As described above, the barrel cap 400' may include a tube receiving recess 420' which may receive an elongated tube 117' and seal the distal end 113b' of the elongated tube 117'. A sealing device 430', such as an O-ring, may seal against the outer surface of the elongated tube 117' to further prevent fluid leakage around the outer surface of the elongated tube 117'. Furthermore, the extension wall 120' contacts the inner surface of the barrel cap connecting end 410', as shown. If mixing of the constituent materials is desired, the barrel cap 400' may be removed from the barrel assembly 100.

[0049]

[0079] Referring here to Figures 7A–7C, another embodiment of the constituent material reservoir 200' and connector 300' is shown. The constituent material reservoir 200' and connector 300' are substantially similar to the constituent material reservoir 200 and connector 300 described above. Accordingly, the descriptions of the constituent material reservoir 200 and connector 300 apply equally to this disclosure unless otherwise stated or evident. Furthermore, similar components are similarly labeled, but include a single quote ('') following the reference numeral.

[0050]

[0080] For example, the constituent material reservoir 200' includes a first storage portion 210a' and a second storage portion 210b' defining internal volumes 211a' and 211b', respectively. Plungers 202a' and 202b' may be received within each internal volume 211a' and 211b', respectively. That is, the reservoir body 205 may define two hollow voids providing separate internal volumes 211a' and 211b'. Referring to Figure 7C, the first storage portion 210a' and the second storage portion 210b are shown as including a first reservoir channel 214a and a second reservoir channel 214b. However, in this embodiment, the directional portion 212 described above is incorporated into the connector 300'.

[0051]

[0081] For example, the connector 300' includes a connector housing 302, which may include a first housing portion 302a' substantially corresponding to the directional portion 212 described above, and a second housing portion 302b' including a connecting end 320'. In some embodiments, the first housing portion 302a' is coupled to the reservoir body 205' by any suitable coupling technique (e.g., adhesive, press-fit, fastener, 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 fluid-coupled to the first reservoir flow path 214a' and directs the flow from the first reservoir flow path 214a' to the centerline C1' of the constituent material reservoir 200'. The first connector channel 314a' may have a second portion 315b', which is fluid-coupled to the first portion 315a' and directs the fluid flow along and / or concentrically with the centerline C1'. The second connector channel 314b' may similarly have a first portion 316a', which is fluid-coupled to the second reservoir channel 214b' and directs the flow from the first reservoir channel 214a' toward the centerline C1' of the constituent material reservoir 200'. The second connector channel 314b' may similarly have a second portion 316b', which is fluid-coupled to the first portion 315a' and directs the flow distally from the first reservoir channel 214a' in a direction parallel to but spaced apart from the centerline C1' of the constituent material reservoir 200'. In some embodiments, a seal 330' (e.g., an O-ring) may be positioned within the first reservoir channel 214a', for example, 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 joined together by any suitable joining technique (e.g., welding, adhesive, press-fit, fasteners, etc.).

[0052]

[0082] Figures 8A and 8B show a reservoir cap 500' coupled to a connector 300' and a constituent material reservoir 200'. As described above, the reservoir cap 500' is coupled to the end of the connector 300' facing the constituent material reservoir 200'. The reservoir cap 500' may include a cap connector 510', which may receive and be coupled to the connecting end 320' of the connector 300'. For example, the cap connector 510' may receive the connecting end 320' of the connector 300' and be coupled to it in a screw-like manner. The reservoir cap 500' may have an extension portion 520', which is received into a first connector channel 314a' and seals against the seal 330' in the first connector channel 314a'. The cap 500' may include a cap extension wall 322' surrounding the extension portion 520'. The cap extension wall 322' may extend into and seal against the inner surface of the cap connector 510. Accordingly, by coupling with the connecting end 320', the reservoir cap 500' seals both the first connector channel 314a' and the second connector channel 314b'.

[0053]

[0083] Figures 9A and 9B show an applicator 700' similar to the applicator 700 described above. Accordingly, applicator 700' is similarly applicable to this disclosure unless otherwise stated or evident. Furthermore, similar components are similarly labeled, but include a "'" following the reference numeral. For example, applicator 700' may include an applicator body 710' including a mounting end 720' for coupling to a mounting structure 140'. For example, the mounting end 720' may be received within the mounting structure 140' and engage therewith, like a screw (although other coupling techniques are intended and possible). As described above, applicator 700' may also define a first applicator channel 714a' and a second applicator channel 714b'. One or more portions of the first applicator channel 714a and the second applicator channel 714b' may be concentric with the centerline C1' when mounted to the barrel assembly 100'. In several embodiments, the first applicator channel 714a' may include an applicator seal 730' (e.g., an O-ring) that, when assembled, seals against the outer surface of the elongated tube 117. The applicator body 710' may be coupled with an inner discharge tube 702a' and an outer discharge tube 702b', with the inner discharge tube 702a' positioned within the outer discharge tube 702b'.

[0054]

[0084] Figures 10A–10J illustrate how to use the mixing syringe system described herein. While specific steps are shown, it should be noted that any number of steps are contemplated and possible. Furthermore, while specific embodiments are used for illustrative purposes, it should be noted that any embodiment of the embodiments herein may be used or operated in substantially similar manner.

[0055]

[0085] In Figures 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 component reservoir 200' and connector 300'. In Figures 10C and 10D, the connector 300' may be inserted over an elongated tube 117' and received by a mounting structure 140'. In this embodiment, the locking member 142' may receive the connection end 320' by a screw engagement. The locking member 142' may be rotated around the connection end 320' to secure the connection end 320' by a screw engagement. As shown, the elongated tube 117' is received into the first connector channel 314a' and engaged by the seal 330'. Similarly, the extension wall 120' may engage with the inner surface of the connection end 320' to form a seal with the inner surface.

[0056]

[0086] When connected, the constituent materials may be mixed. As shown in Figure 10E, the first liquid constituent material 40a (also called the first diluent) may be positioned in the first barrel 110a', and the second liquid constituent material 40b (also called the second diluent) may be positioned in the second barrel 110b'. As stated above, the liquid constituent materials 40a and 40b may be the same or different. The liquid constituent material may include any diluent as described above. The first powdered constituent material 42a (also called the first powder) may be positioned in the first storage section 210a', and the second powdered constituent material 42b (also called the second powder) may be positioned in the second storage section 210b'. The powdered constituent material may include any of the materials described above, and may be the same or different from each other. By simultaneously or separately pressing the plungers 102a' and 102b', the liquid components 40a and 40b may advance into their respective reservoir sections 210a' and 210b'. For example, the first liquid component 40a may pass through the first liquid channel 114a' (including passing through the elongated tube 117') and enter the first connector channel 314a'. The first connector channel 314a' may then direct the first liquid component 40a into the first reservoir channel 214a' and into the first storage section 210a'. Similarly, the second liquid component 40b may pass through the second liquid channel 114b'. The first connector channel 314b' may then direct the second liquid component 40b into the second reservoir channel 214b' and into the second storage section 210b'. The fluid flow along each path is indicated by streamlines 60a and 60b. The assembly may then be agitated (e.g., shaken) to thoroughly mix the liquid components 40a, 40b with their respective powdered components 42a, 42b. In some embodiments, agitation may be provided by pushing and / or pulling various plungers 102a', 102b', 202a', 202b' to generate turbulence for further mixing.As shown in Figure 10F, the resulting mixture provides a first mixture 44a in the first storage section 210a' and a second mixture 44b in the second storage section 210b'. Once mixing is complete, plungers 102a', 102b', 202a', and / or 202b' may retract or advance to move the first mixture 44a and the second mixture 44b back along the flow lines 60a, 60b and into the first barrel 110 and the second barrel 110b', respectively. For example, the first plunger 102a' may retract to pull the first mixture 44a back into the first barrel 110a'. Similarly, the second plunger 102b' may retract to pull the second mixture 44b back into the second barrel 110b'.

[0057]

[0087] Referring here to Figure 10G, the component reservoir 200' and connector 300' may be detached from the barrel assembly 100'. For example, the locking member 142' may be rotated to allow the connector 300' to detach from the 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 the mounting portion 140' and engaged therein like a screw, as shown in Figure 10H. For example, the locking member 142' may be rotated to securely fasten onto the mounting end 720'. The elongated tube 117' may be received within the first applicator channel 714a', and the applicator seal 730' may seal against the outer surface of the elongated tube 117'. In this way, flow between the first applicator channel 714a' and the second applicator channel 714b' may be prevented. Furthermore, the extension wall 120' may engage with the inner surface of the mounting end 720' to form a seal with the inner surface.

[0058]

[0088] Referring to Figures 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 affected tissue and healthy tissue. The first mixture 44a and the second mixture 44b may then be delivered through their respective channels. For example, when the first plunger 102a' is pressed, the first mixture 44a may pass through the first liquid channel 114a' of the barrel assembly 100' and distally through the elongated tube 117'. The elongated tube 117' may then direct the mixture into the first applicator channel 714a' so that it passes through the inner delivery tube 702a'. This path is indicated by the streamline 62a. Similarly, when the second plunger 102b' is pressed, the second mixture 44b may pass through the second liquid channel 114b' of the barrel assembly 100', along the outer surface of the elongated tube 117', and into the second applicator channel 714b', and the second mixture 44b may move along the outer surface of the inner discharge tube 702a' within the outer discharge tube 702b'. Such flow is indicated by the flow lines 62b. In some embodiments, the inner discharge tube 702a' may end within a few millimeters (e.g., less than 5 millimeters, e.g., 3 millimeters or less) from the end of the outer discharge tube 702b'. Such a thing may help prevent clogging while dispensing the first mixture 44a and the second mixture 44b. As shown, when the first mixture 44a and the second mixture 44b come into contact, they may gel to provide a substance 46 which may be a radiation spacer or other type of implant.

[0059]

[0089] In various embodiments, the components described herein may be provided as a kit. The constituent materials may be provided in pre-measured quantities by a barrel assembly and a constituent material reservoir. Accordingly, ease of use of the system may be provided. Furthermore, embodiments having the Luer-type coupling described herein may facilitate assembly and disassembly of the components by a practitioner. In some embodiments, other components may be easily combined. For example, a practitioner may connect a standard syringe to the applicator 700 and hydrodissect, for example, with saline or inject other solutions through a double-lumen delivery tube structure. The embodiments described herein provide a seamless interface to prevent leakage between components and easy, intuitive assembly / delivery.

[0060]

[0090] Further features may be described in relation 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, defining a first fluid passage from the first barrel and a second fluid passage from the second barrel, wherein at least a portion of the first fluid passage is located within the second fluid passage; a constituent material reservoir comprising a first storage portion and a second storage portion, defining a first reservoir passage and a second reservoir passage offset from the first reservoir passage; and a connector housing configured to connect the barrel assembly to the constituent material reservoir, defining a first connector passage and a second connector passage, wherein the first connector passage fluidly couples the first fluid passage to the first reservoir passage, and the second connector passage fluidly couples the second fluid passage to the second reservoir passage.

[0061]

[0092] 2. A mixing syringe system as described in Clause 1, wherein the connector housing is screw-like to the barrel assembly.

[0062]

[0093] 3. A mixing syringe system according to Clause 1 or 2, wherein the connector housing comprises a first needle fluid-coupled to the first connector channel and a second needle fluid-coupled to the second connector channel.

[0063]

[0094] 4. A mixing syringe system according to any one of clauses 1 to 3, wherein the barrel assembly comprises an elongated tube that forms part of the first fluid passage, and the connector housing receives the elongated tube into the first connector passage.

[0064]

[0095] 5. A mixing syringe system as described in Clause 4, wherein the elongated tube is positioned concentrically within the second fluid passage.

[0096] 6. A mixing syringe system according to Clause 4 or 5, wherein at least a portion of the second connector channel surrounds the elongated tube.

[0065]

[0097] 7. A mixing syringe system according to any one of clauses 1 to 6, wherein a portion of the first connector flow path is coaxial with a portion of the second connector flow path.

[0066]

[0098] 8. A mixing syringe system according to any one of clauses 1 to 7, further comprising a spacer configured to hold the barrel assembly in a spaced-out relationship with respect to the constituent material reservoir.

[0067]

[0099] 9. A mixing syringe system for mixing constituent materials, comprising a barrel assembly comprising a first barrel and a second barrel, defining a first fluid passage from the first barrel and a second fluid passage from the second barrel, wherein at least a portion of the first fluid passage is located within the second fluid passage; and a barrel assembly comprising a first storage portion and a second storage portion, defining a first reservoir passage and a second reservoir passage offset from the first reservoir passage. A mixing syringe system comprising a reservoir, a connector housing configured to connect the barrel assembly to the constituent material reservoir, the connector housing defining a first connector channel and a second connector channel, the first connector channel fluidly coupling the first fluid channel to the first reservoir channel, and the second connector channel fluidly coupling the second fluid channel to the second reservoir channel, and an applicator configured to be detachably coupled to the barrel assembly.

[0068]

[0100] 10. A mixing syringe system as described in Clause 9, wherein the connector housing is screw-connected to the barrel assembly.

[0069]

[0101] 11. A mixing syringe system according to Clause 9 or 10, wherein the connector housing comprises a first needle fluid-coupled to the first connector channel and a second needle fluid-coupled to the second fluid channel.

[0070]

[0102] 12. A mixing syringe system according to any one of clauses 9 to 11, wherein the barrel assembly comprises an elongated tube that forms part of the first fluid passage, and the connector housing receives the elongated tube into the first connector passage.

[0071]

[0103] 13. A mixing syringe system according to Clause 12, wherein the elongated tube is positioned concentrically within the second fluid passage.

[0104] 14. A mixing syringe system according to Clause 13, wherein at least a portion of the second connector channel surrounds the elongated tube.

[0072]

[0105] 15. A mixing syringe system according to any one of clauses 9 to 14, wherein a portion of the first connector channel is coaxial with a portion of the second connector channel.

[0073]

[0106] 16. A mixing syringe system according to any one of clauses 9 to 15, further comprising a spacer configured to hold the barrel assembly in a spaced-out relationship with respect to the constituent material reservoir.

[0074]

[0107] 17. A method for mixing constituent materials, comprising connecting a barrel assembly to a constituent material reservoir, the barrel assembly comprising a first barrel and a second barrel, defining a first fluid passage from the first barrel and a second fluid passage from the second barrel, at least a portion of the first fluid passage being located within the second fluid passage, the constituent material reservoir comprising a first storage section and a second storage section, defining a first reservoir passage and a second reservoir passage offset from the first reservoir passage, and advancing a first plunger through the barrel assembly, thereby advancing a first diluent in the first barrel through the first fluid passage into the first storage section, to mix the first diluent with a first powder in the first storage section.

[0075]

[0108] 18. A method according to Clause 17, further comprising withdrawing the first plunger, thereby drawing the first mixture of the first diluent and the first powder into the first barrel.

[0076]

[0109] 19. A method according to Clause 17 or 18, further comprising advancing a second plunger through the barrel assembly, thereby advancing the second diluent in the first barrel through the second fluid passage into the second storage portion, to mix the second diluent with the second powder in the second storage portion.

[0077]

[0110] 20. A method according to Clause 19, further comprising withdrawing the second plunger, thereby drawing the second mixture of the second diluent and the second powder into the second barrel.

[0078]

[0111] While specific embodiments have been shown and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Furthermore, while various aspects of the claimed subject matter have been described herein, such aspects do not need to be used in combination. Therefore, the appended claims are intended to cover all such changes and modifications that fall within the scope of the claimed subject matter.

Claims

1. A mixing syringe system for mixing constituent materials, A barrel assembly comprising a first barrel and a second barrel, defining a first fluid passage from the first barrel and a second fluid passage from the second barrel, wherein at least a portion of the first fluid passage is located within the second fluid passage, A constituent material reservoir comprising a first storage section and a second storage section, defining a first reservoir channel and a second reservoir channel offset from the first reservoir channel, A mixing syringe system comprising a connector housing configured to connect the barrel assembly to the constituent material reservoir, the connector housing defining a first connector channel and a second connector channel, wherein the first connector channel fluidly couples the first fluid channel to the first reservoir channel, and the second connector channel fluidly couples the second fluid channel to the second reservoir channel.

2. A mixing syringe system according to claim 1, wherein the connector housing is screw-like to the barrel assembly.

3. A mixing syringe system according to claim 1, wherein the connector housing comprises a first needle fluid-coupled to a first connector flow path and a second needle fluid-coupled to a second connector flow path.

4. A mixing syringe system according to claim 1, The barrel assembly comprises an elongated tube that forms part of the first fluid passage, The connector housing is a mixing syringe system that receives the elongated tube into the first connector channel.

5. A mixing syringe system according to claim 4, wherein the elongated tube is positioned concentrically within the second fluid flow path.

6. A mixing syringe system according to claim 4, wherein at least a portion of the second connector channel surrounds the elongated tube.

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

8. A mixing syringe system according to claim 1, further comprising a spacer configured to hold the barrel assembly in a spaced-out relationship with respect to the constituent material reservoir.

9. A mixing syringe system for mixing constituent materials, A barrel assembly comprising a first barrel and a second barrel, defining a first fluid passage from the first barrel and a second fluid passage from the second barrel, wherein at least a portion of the first fluid passage is located within the second fluid passage, A constituent material reservoir comprising a first storage section and a second storage section, defining a first reservoir channel and a second reservoir channel offset from the first reservoir channel, A connector housing configured to connect the barrel assembly to the constituent material reservoir, comprising a connector housing that defines a first connector flow path and a second connector flow path, wherein the first connector flow path fluidly couples the first fluid flow path to the first reservoir flow path, and the second connector flow path fluidly couples the second fluid flow path to the second reservoir flow path, A mixing syringe system comprising an applicator configured to be detachably coupled to the barrel assembly.

10. A mixing syringe system according to claim 9, wherein the connector housing is screw-like to the barrel assembly.

11. A mixing syringe system according to claim 9, wherein the connector housing comprises a first needle fluid-coupled to the first connector flow path and a second needle fluid-coupled to the second fluid flow path.

12. A mixing syringe system according to claim 9, The barrel assembly comprises an elongated tube that forms part of the first fluid passage, The connector housing is a mixing syringe system that receives the elongated tube into the first connector channel.

13. A mixing syringe system according to claim 4, wherein the elongated tube is positioned concentrically within the second fluid flow path.

14. A mixing syringe system according to claim 13, wherein at least a portion of the second connector channel surrounds the elongated tube.

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

16. A mixing syringe system according to claim 9, further comprising a spacer configured to hold the barrel assembly in a spaced-out relationship with respect to the constituent material reservoir.

17. A method for mixing constituent materials, The step includes joining the barrel assembly to the component material reservoir, The barrel assembly comprises a first barrel and a second barrel, defining a first fluid passage from the first barrel and a second fluid passage from the second barrel, with at least a portion of the first fluid passage positioned within the second fluid passage. The constituent material reservoir comprises a first storage portion and a second storage portion, defining a first reservoir flow path and a second reservoir flow path offset from the first reservoir flow path. A method comprising the step of advancing a first plunger through the barrel assembly, thereby advancing a first diluent in the first barrel through the first fluid channel into the first storage portion, and mixing the first diluent with the first powder in the first storage portion.

18. A method according to claim 17, further comprising the step of withdrawing the first plunger, thereby drawing the first mixture of the first diluent and the first powder into the first barrel.

19. A method according to claim 17, further comprising the step of advancing a second plunger through the barrel assembly, thereby advancing the second diluent in the first barrel through the second fluid channel into the second storage portion, to mix the second diluent with the second powder in the second storage portion.

20. A method according to claim 19, further comprising the step of withdrawing the second plunger, thereby drawing the second mixture of the second diluent and the second powder into the second barrel.

Images